HK1088236B - A composition for promoting defecation to expelling toxin and losing weight and reducing blood fat and the preparation method thereof - Google Patents

Description

Composition with functions of relaxing bowels, expelling toxin, losing weight and reducing fat and preparation method thereof

Technical Field

The invention relates to a traditional Chinese medicine composition with functions of relaxing bowels, expelling toxin, losing weight and reducing fat, in particular to a medicine which is prepared by taking plant Chinese herbal medicines as raw materials and has functions of relaxing bowels, expelling toxin, losing weight and reducing fat.

Background

In real life, one person in ten people has the problem of constipation. Constipation is not considered to be a big disease, but seriously affects the quality of life of people and brings much trouble to people. Physicians commonly classify constipation into three major categories: slow transit, outlet obstruction, and mixed. The currently clinically applied drugs for treating constipation include: bulk laxatives, stimulant laxatives, lubricity laxatives, osmotic laxatives, and the like. The principal representative of bulk purgatives is magnesium sulfate. However, it is not suitable for patients with intestinal hypomotility because it does not increase the colonic tension. The stimulant laxatives are mainly used for people with constipation and need to relieve constipation, and are not suitable for long-term application because they stimulate the intestinal mucosa and intestinal wall nerve plexus and may cause large intestine muscle weakness to form drug dependence. The main disadvantages of lubricity purgatives are poor taste and weak action, and poor absorption of fat-soluble vitamins caused by long-term application. The main disadvantage of osmotic laxatives is that they ferment under the action of bacteria to produce gas, which causes discomfort such as abdominal distension.

Traditional Chinese medicine accumulates abundant clinical experience in long-term treatment practice. However, the modern Chinese medicament which utilizes the modern technology and combines the modern preparation process has not been provided so far.

Disclosure of Invention

The invention aims to provide a traditional Chinese medicine composition with functions of relaxing bowels, expelling toxin, losing weight and reducing fat, which can quickly and effectively treat constipation and greatly reduce stimulation to intestinal tracts and other physiological injuries.

The invention also aims to provide a preparation method of the traditional Chinese medicine composition.

In order to achieve the purpose, the novel formula of the medicine is formed by combining the modern pharmacological research achievement and various previous proved formulas according to the understanding and the treatment principle of the traditional Chinese medicine on intestinal diseases such as constipation and the like, removing grains and extracting essence according to the theory of the traditional Chinese medicine.

The raw materials for preparing the medicine comprise the following components in percentage by weight:

25-400 parts of polygonum multiflorum, 30-500 parts of cassia seed and 30-600 parts of aloe.

30-150 parts of medlar, 30-150 parts of donkey-hide gelatin, 20-100 parts of ginseng

The raw materials for preparing the medicine also contain the following components in percentage by weight:

50-200 parts of immature bitter orange and 20-100 parts of bighead atractylodes rhizome

The preferable weight ratio of the raw materials for preparing the medicine of the invention is as follows:

60-150 parts of polygonum multiflorum, 80-180 parts of cassia seed, 100 parts of aloe and 200 parts of aloe

30-100 parts of medlar, 30-100 parts of donkey-hide gelatin, 20-80 parts of ginseng

80-150 parts of immature bitter orange and 20-80 parts of bighead atractylodes rhizome

The optimal weight ratio of the raw materials is as follows:

80-120 parts of polygonum multiflorum, 100 parts of cassia seed, 150 parts of aloe and 160 parts of aloe

50-80 parts of medlar, 40-80 parts of donkey-hide gelatin, 20-50 parts of ginseng

80-120 parts of immature bitter orange and 30-50 parts of bighead atractylodes rhizome

In the above formula, fructus Aurantii Immaturus and Atractylodis rhizoma can be replaced by one or two of radix aucklandiae and pericarpium Citri Tangerinae, colla Corii Asini can be replaced by radix Angelicae sinensis, and one or more of Polygoni Multiflori radix, semen Cassiae and Aloe can be replaced by radix et rhizoma Rhei.

The raw materials can be prepared into common clinical medicine dosage forms, such as pills, tablets, granules, oral liquid, capsules, paste, emulsions, chewable agents, injections and the like according to a conventional preparation process.

Preferably capsules, tablets, granules.

The method for measuring the active ingredients of the solid dosage form comprises the following steps:

(1) method for measuring ginsenoside

Preparation of control solutions: accurately weighing ginsenoside Rg₁Adding methanol to appropriate amount of Re reference substances to obtain ginsenoside Rg contained in 1ml₁0.5mg and 0.4mg of ginsenoside Re0.4mg as reference solutions;

preparation of a test solution: pulverizing the product, precisely weighing about 1.0g, dissolving in water, filtering, extracting with water saturated n-butanol for 4 times, washing the extractive solution with sodium hydroxide solution twice, evaporating n-butanol in evaporating dish, dissolving in methanol, and filtering;

chromatographic conditions are as follows: octadecylsilane chemically bonded silica is used as a filling agent;

acetonitrile-0.05% phosphoric acid solution with volume ratio of 99: 400 as mobile phase;

the detection wavelength is 203 nm;

the determination method comprises the following steps: precisely sucking 10 μ l of each of the reference solution and the sample solution, and measuring with liquid chromatograph.

(2) Emodin determination method

Preparation of control solutions: accurately weighing emodin reference substance 5mg, placing in 50ml measuring flask, dissolving and diluting with methanol, measuring 1ml, placing in 25ml measuring flask, adding methanol to scale, and making into solution containing emodin 4 μ g per 1ml as reference solution;

preparation of a test solution: pulverizing the product, precisely weighing about 1.0g, dissolving in water, filtering, evaporating, dissolving in methanol, filtering, volatilizing methanol, adding 10ml of 2.5mol/L sulfuric acid solution, ultrasonic treating for 5min, adding 10ml of chloroform, heating under reflux for 1 hr, cooling, transferring to a separating funnel, washing the container with a small amount of chloroform, adding into the separating funnel, separating chloroform layer, extracting with chloroform, mixing chloroform layers, dehydrating with anhydrous sodium sulfate, volatilizing chloroform solution, precisely adding 10ml of methanol into the residue, and dissolving.

Chromatographic conditions are as follows: octadecylsilane chemically bonded silica is used as a filling agent;

methanol-0.1 percent phosphoric acid solution with the volume ratio of 85: 15 is taken as a mobile phase;

the detection wavelength is 254 nm;

the determination method comprises the following steps: precisely sucking 5 μ l of each of the reference solution and the sample solution, and measuring with liquid chromatograph.

Each gram of solid content contains: ginsenoside Rg₁And ginsenoside Re 0.08-1.5 mg and emodin 1-100 mg.

The preparation process of the preparation of the invention is as follows:

grinding colla Corii Asini into fine powder (80 mesh) or melting; extracting Ginseng radix, Polygoni Multiflori radix, semen Cassiae and Aloe with alcohol, refluxing with 40-80% ethanol for 1-3 times, each for 1-3 hr, filtering, recovering ethanol, and concentrating; adding 5-10 times of water into the medlar, the immature bitter orange and the white atractylodes rhizome, soaking for 0.5-3 hours, decocting for 1-3 hours, adding 5-10 times of water, and decocting for 1-3 hours; mixing decoctions, filtering, concentrating under reduced pressure to water ratio of 1: 1-3: 1, adjusting alcohol to 40-85%, cold precipitating for 12-48 hr, filtering, concentrating under reduced pressure to obtain extract, mixing with the ethanol reflux extract or drying, adding colla Corii Asini powder or melted solution and adjuvant, and making into clinically acceptable dosage forms by conventional preparation method.

The medicine provided by the invention has a good curative effect on constipation. To show the therapeutic effect of the present invention on constipation, we made a lot of experimental studies, and the following experimental examples are used to further illustrate the present invention.

Pharmacodynamics of the preparation of the invention

1. Mouse small intestine propulsion test of the preparation of the invention

The purpose is as follows: the effect of the formulation of the present invention on the rate of intestinal transit in mice was observed.

1.1 materials and methods

1.1.1 animals:

60 Kunming mice, each half of which is male and female, weigh 18-22 g, are raised in advance for three days to adapt to the environment. The animal center of Nanjing university of traditional Chinese medicine provides, the certification number: SYXK (Su) 2002-0053.

1.1.2 drugs:

the preparation of the invention is provided by Shandong Lunan pharmaceutical Co.

From cisapride, siennan, poplarm, pharmaceutical co.

Activated carbon (powder) is available from Shanghai chemical reagent company of China medicine (group).

1.1.3 Instrument:

surgical instruments, scales, glass plates, etc

1.1.4 medicine preparation:

the original medicine of the preparation of the invention is tawny traditional Chinese medicine dry powder, and according to the dosage requirement, the preparation dry powder of the invention is prepared into large, medium and small doses by using 10 percent carbon powder aqueous solution. The cisapride is prepared into a liquid medicine of 0.195mg/ml by using a 10% aqueous solution of charcoal as a positive medicine. The preparation is administered by intragastric administration at 10ml/kg, i.e. at dosage of 5.38g crude drug/kg (large dose), 1.79g crude drug/kg (medium dose) and 0.60g crude drug/kg (small dose), cisapride 1.95mg/kg as positive drug control group, and blank group is administered with 10% charcoal powder aqueous solution of the same volume.

1.1.5 methods of experiment:

60 healthy Kunming mice were taken, half female and half male, fasted for 24 hours, and randomly divided into 6 groups of 10 mice (half female and half male). Preparing 10% suspension with carbon powder as marker and physiological saline as control group respectively; the positive group is prepared into three dose groups of 1.95mg/kg (0.195mg/ml) liquid medicine and 0.60, 1.79g and 5.38g crude drug/kg by using 10% carbon powder water solution. The tested drugs of each dosage group are prepared by 10 percent carbon powder suspension, and are administrated by intragastric administration of 0.1ml/10g mice, and cervical dislocation is killed 30 minutes after intragastric administration. Immediately, the gastrointestinal tract was removed by laparotomy, laid flat on a glass plate, and the distance traveled by the carbon tip in the intestine and the small intestine (from the pylorus to the ileocecal region) were measured to calculate the percent propulsion. And (4) carrying out statistical analysis on the test results, comparing each administration group with a normal control group, carrying out t test between groups, and judging whether a significant difference exists.

1.2 results of the experiment

1.2.1 carbon dust propelling test results are shown in Table 1.

TABLE 1 Effect of the formulations of the present invention on the propulsion of charcoal dust in the small intestine of mice (χ + -SD)

^*0.05＜P＜0.01，^***P < 0.001 compared to blank

As can be seen from Table 1, the preparation of the present invention has the effect of promoting the intestinal peristalsis of normal mice with the crude drugs of 0.60, 1.79 and 5.38 g/kg, andwith significant difference (^*P＜0.05 ^**P＜0.01 ^***P＜0.001)。

During the study we found: the bitter orange and the white atractylodes rhizome have no obvious difference in curative effect by replacing the costustoot and the tangerine peel.

2. Effect of the preparation of the present invention on Constipation model mouse intestinal propulsion

The purpose is as follows: the effect of the preparation of the present invention on the rate of intestinal transit in constipation model mice was observed.

2.1 materials and methods

2.1.1 animals:

60 Kunming mice, male and female, with the weight of 18-22 g, are raised in advance for three days to adapt to the environment. The animal center of Nanjing university of traditional Chinese medicine provides, the certification number: SYXK (Su) 2002-0053.

2.1.2 drugs:

the preparation of the invention is provided by Shandong Lunan pharmaceutical Co.

From cisapride, siennan, poplarm, pharmaceutical co.

Activated carbon (powder) is available from Shanghai chemical reagent company of China medicine (group).

The product of compound diphenoxylate Changzhou Kangpu pharmaceutical Co Ltd (Wu-jin pharmaceutical factory operated in the former country)

2.1.3 Instrument:

surgical instruments, scales, glass plates, etc

2.1.4 medicine preparation:

the original medicine of the preparation is tawny traditional Chinese medicine dry powder, and according to the dosage requirement, the dry powder 3 of the preparation uses 10 percent carbon powder aqueous solution liquid medicine as large, medium and small dosage. The cisapride is prepared into 0.195mg/ml by using 10% charcoal aqueous solution and is administrated by intragastric administration according to 10ml/kg, 1.95mg/kg of cisapride is taken as a test positive drug control group, and the blank group is administrated with 10% charcoal powder aqueous solution with the same volume. The molding medicine compound diphenoxylate (2.5 mg/tablet) is prepared into 2.5mg/ml, 50 tablets are prepared into 50ml by normal saline, and the stomach is irrigated according to 10ml/kg, namely the dosage is 0.025 g/kg..

2.1.5 methods of experiment:

taking 60 mice, each half of male and female, randomly dividing the mice into 6 groups, and 10 mice (each half of male and female), setting 3 dose groups of small, medium and large, respectively 5.38, 1.79 and 0.60g of crude drug/kg, setting 1.95g/kg of cisapride as a positive control group, and giving 10% carbon powder suspension to the blank control group and the model group, wherein the groups are administrated to the mice by gastric lavage according to 10 ml/kg. Before the experiment, animals in each group are fasted for 24h (free drinking water), the experiment is started, the model group, the positive group and the 3 dosage groups of the preparation are respectively administered with the compound diphenoxylate at the rate of 20mg/kg, and the blank control group is administered with the same volume of distilled water. After 30min, 10ml/kg of 10% charcoal powder-containing drug suspension is respectively administered at corresponding dose. 30min later, cervical vertebrae were removed to kill the animals, the abdominal cavity was opened to separate mesentery, the intestinal canal from the pylorus, the lower end to the ileocaecal region at the upper end was cut and placed on a glass plate, the small intestine was gently pulled into a straight line, the length of the intestinal canal was measured as the "total length of the small intestine", the length of the ink advanced from the pylorus to the front edge of the ink was measured as the "ink advanced length", and the ink advanced rate between groups was calculated. The test results were statistically processed and are shown in Table 2

2.2 results of the experiment

TABLE 2 Effect of the formulations of the present invention on Constipation mouse intestinal transit (χ + -SD)

# P < 0.001 compared with blank group,^*P＜0.05 ^**P＜0.01 ^***p < 0.001 compared to model group

As shown in Table 2, the preparation of the present invention has the effect of promoting the peristalsis of constipation model mice in the dosage groups of 1.79 and 5.38g crude drug/kg, and has significant difference (^*P＜0.05 ^**P＜0.01 ^***P is less than 0.001), no effect of 0.60g crude drug/kg of the preparation of the invention on the small intestine peristalsis of constipation model mice is observed (P is more than 0.05)

During the study we found: the colla Corii Asini is replaced by radix Angelicae sinensis with unchanged curative effect.

3. Test for counting wet feces of mice in constipation model by using preparation provided by the invention

The purpose is as follows: the effect of the preparation of the present invention on the time required for the first defecation of a constipation model mouse and the number, weight and frequency of the defecation granules in different time periods were observed.

3.1 test materials:

3.1.1 animals:

60 Kunming mice, half of which are male and female, weigh 1g to 22g, are raised in advance for three days to adapt to the environment. The animal center of Nanjing university of traditional Chinese medicine provides, the certification number: SYXK (Su) 2002-0053.

3.1.2 test drugs:

the preparation of the invention is provided by Shandong Lunan pharmaceutical Co.

From cisapride, siennan, poplarm, pharmaceutical co.

Activated carbon (powder) is available from Shanghai chemical reagent company of China medicine (group).

The compound diphenoxylate Changzhou Kangpu pharmaceutical industry Limited company (the former country has armed forces into the pharmaceutical factory).

3.1.3 Instrument:

mouse metabolism cage and the like

3.1.3 preparation of the medicine:

the original medicine of the preparation of the invention is tawny traditional Chinese medicine dry powder, and the dry powder of the preparation of the invention is mixed with 10 percent carbon powder aqueous solution according to the dosage requirement to prepare large, medium and small dosage. The cisapride is prepared into 0.195mg/ml by using 10% carbon powder aqueous solution and is administrated by intragastric administration according to 10ml/kg, 1.95g/kg of cisapride is used as a test positive drug control group, and the same volume of 10% carbon powder aqueous solution is administrated to a blank group. The molding medicine compound diphenoxylate (2.5 mg/tablet) is prepared into 2.5mg/ml, 50 tablets are prepared into 50ml by normal saline, and the stomach is irrigated according to 10ml/kg, namely the dosage is 0.025 g/kg..

3.1.4 Experimental methods:

60 mice are taken, the grouping and administration methods are the same as 2.1.5, animals in each group before the experiment are fasted for 12 hours (free drinking water), the experiment is started, a model group, a positive group and 3 dose groups of the preparation of the invention, 5.38, 1.79 and 0.60g crude drug/kg, the compound diphenoxylate is orally administered to the mice according to 20mg/kg respectively, and the blank control group is administered with distilled water with the same volume. After 30min, the positive group and the three dose groups of the preparation of the invention are respectively gavaged with 10% carbon powder drug suspension to mice according to 10 ml/kg. The model group and the blank control group are both given with the same volume of 10% carbon powder-containing aqueous solution, the 6 groups of animals are all placed in a mouse metabolism cage for observation, normal drinking water is carried out, the time required by the first defecation of each animal is recorded by taking the first defecation of the mouse as a standard, the accumulated defecation grain number and the defecation weight (wet weight) of the 2h, 4h, 6h and 8h mice are respectively observed, and the defecation frequency is calculated. The test results were statistically processed.

3.2 Experimental results:

the test results are shown in Table 3

4. Effect of the formulations of the invention on the gastrointestinal phenol Red content of rats

4.1 test materials and methods:

4.1.1 animals:

the SD rats are 40, can be used for both male and female, have the weight of 180-220 g, and are raised for three days in advance to adapt to the environment. The animal center of Nanjing university of traditional Chinese medicine provides, the certification number: SYXK (Su) 2002-0053.

4.1.2 drugs:

the preparation is provided by Shandong Lunan pharmaceutical Co Ltd

② Xishabili Xian Yanseng pharmaceutical Co Ltd

③ phenol Red Shanghai reagent three factories

Fourthly, four factory of Shanghai reagent of sodium hydroxide

Experimental plant of special schools such as Shanghai chemical engineering of barium hydroxide

Barium sulfate Shanghai Shaxing reagent factory

4.1.3 Instrument:

electronic balance, Shanghai balance instrument factory

② centrifuge Germany

③ Spctiamax190 American MD

4.1.4 drug configuration:

the original medicine of the preparation of the invention is tawny traditional Chinese medicine dry powder, and according to the dosage requirement, the dry powder is mixed with distilled water to prepare large dose, medium dose and small dose. The cisapride is prepared into a liquid medicine of 0.135mg/ml as a positive medicine. The preparation is administered by intragastric administration at 10ml/kg, i.e. the dosage is 3.73g crude drug/kg (large dose), 1.24g crude drug/kg (medium dose) and 0.41g crude drug/kg (small dose), 1.35mg/kg of cisapride is used as a positive drug control group, and the blank group is administered with the same volume of physiological saline. Phenol red dextrin: heating 10% phenol red solution at a ratio of 1g flour per 15ml to obtain dextrin. Phenol red solution: accurately preparing 1.0 mg% phenol red solution, dividing into 10 tubes from 0-9 ml with gradient of 1ml, sequentially adding 0.1% NaOH to make the volume of each tube reach 10ml, and mixing thoroughly.

4.1.5 methods of experiment:

taking 50 SD rats with half each male and female, randomly dividing into four groups, 10 rats (half each male and female), after fasting for 48 hours, starting an experiment, and testing drug groups: 0.41, 1.24 and 3.73g crude drugs/kg, 1.35mg/kg positive drug cisapride, and the same volume of normal saline is given to a control group, and the control group is respectively administrated to rats by gastric gavage with 10 ml/kg. 1.5h after administration, phenol red paste 1ml/100g was orally administered. After 30min, the animal was sacrificed by cutting its head, and the abdomen was opened along the midline of the abdomen, and the cardia, pylorus and ileocecal part were ligated to free the stomach and small intestine. Equally dividing the small intestine section into 6 sections, sequentially cutting, washing the content with distilled water, finally fixing the volume to 6ml, and then respectively adding 0.15nmol/l of Ba (OH)₂2ml, fully mixing, standing for 3-5 minutes, and adding 2ml of 5% ZnSO₂After shaking forcefully and uniformly, centrifuging for 10min at 3000r/min, taking 4ml of supernatant, adding 10% NaOH0.5ml, mixing, measuring the optical density value, and checking the phenol red content in each section of small intestine by referring to a phenol red standard curve, thereby quantitatively judging the small intestine excretion function status of the rat to show the change range of the gastrointestinal excretion function. The residual quantity of phenol red in the stomach and intestinal tracts of animals of different groups is measured and used as an indication of the change of the gastrointestinal excretion function.

4.2 Experimental results:

the test results are shown in Table 4

The results show that the preparation of the invention has the phenol red content in each intestinal segment and the phenol red content in the blank group of 3.73g and 1.24g crude drug/kg dose groupsAll comparisons are significantly different (^*P＜0.05 ^**p＜0.01 ^***p is less than 0.001), the 0.41g crude drug/kg dose group has significant difference in I, II intestinal segment compared with the blank group (^*P＜0.05 ^***p is less than 0.001), so that the preparation has obvious promotion effect on the small intestine excretion function of rats by quantitative judgment.

5. Effect of the preparation of the invention on isolated ileum of rabbits

The influence of the drug on the contraction frequency and amplitude of the spontaneous activities of the duodenum of the rabbits is observed.

5.1 test materials and methods:

5.1.1 animals:

japanese big ear white rabbits, 4-6 kg weight, are raised in advance for three days to adapt to the environment. The animal center of Nanjing university of traditional Chinese medicine provides, the certification number: SYXK (Su) 2002-0053.

5.1.2 drugs:

the preparation is provided by Shandong Lunan pharmaceutical Co.

② Xishabili Xian Yanseng pharmaceutical Co.

③ a pharmaceutical factory of Jiangsu Nantong, atropine sulfate.

The other reagents are all chemical pure commercial products.

5.1.3 Instrument:

[ PowerLab Australian AD instruments Co

② micro sample injector

③ centrifuger

5.1.4 preparation of the medicine:

according to the dosage requirement, 2.5g of the preparation dry powder (1g crude drug/0.29 g dry powder) is diluted to 20ml (8.62g crude drug/ml) by distilled water, the supernatant is taken by centrifugation to obtain a large dose, 8ml of the supernatant is taken out and distilledDiluting with water to 24ml (2.87g crude drug/ml), collecting 10ml, diluting with distilled water to 30ml (0.96g crude drug/ml), collecting 10ml, and diluting with distilled water to 30ml (0.32g crude drug/ml); 10ul of the solution was added to the bath at the respective final concentrations: 5.747X 10^-3、1.916×10^-3、6.385×10^-4、2.128×10^-4g/ml。

5.1.5 methods of experiment:

taking Japanese big ear white rabbits with the weight of 1000 +/-100 g, and taking off cervical vertebrae to kill after the rabbits are both male and female and are fasted for 24 hours without water prohibition. Laparotomy, remove mesentery by surgical scissors, take out ileum, place in dish, wash gently for several times, and tie the two ends with thread. Hanging isolated ileum in Mai's bath containing Kreb's solution, attaching one end of the isolated ileum to an L-shaped ventilation tube, fixing, and supplying 5% CO₂The other end of the oxygen is fixed on a pressure transducer, the load is preset to be 1g, the bath temperature is 37.5 ℃, the stability is 1h, and the MacLab is used for tracing. After the spontaneous rhythm has recovered, the baseline is traced and a fresh preparation of atropine sulfate solution (final concentration 6.7X 10) is administered at an appropriate concentration^-7) Tracing the intestinal canal contraction curve, and after tracing is finished, washing for 2-3 times by Kreb's solution, wherein each time interval is 5 min; after the spontaneous rhythm is recovered, a test drug with a certain concentration is given, the contraction curve of atropine sulfate is measured as above, the contraction height after histamine is added is measured, and the amplitude reduction rate is calculated.

5.1.6 results of the experiment:

table 5. effect of the formulation of the invention on isolated ileum of rabbits (χ ± SD) n ═ 6

Compared with atropine group^*，p＜0.05，^**p is less than 0.01 compared with atropine group

The results show that the preparation of the invention can antagonize atropine to enlarge the contraction amplitude of spontaneous activity of intestinal smooth muscle,results before and after administration were tested by paired t-tests, and differences were significant (< 0.01). But had no effect on the frequency of contraction (P > 0.05). The formulation of the present invention was found to be 5.747X 10^-3、1.916×10^-3、6.385×10^-4It can excite smooth muscle of gastrointestinal tract.

The following examples are provided to further disclose the present invention, and it should be noted that these examples are only the preferred embodiments of the present invention, and do not limit the scope of the present invention as claimed.

Example 1

25 parts of polygonum multiflorum, 500 parts of cassia seed and 600 parts of aloe

150 parts of medlar, 150 parts of donkey-hide gelatin, 100 parts of ginseng

Grinding colla Corii Asini into fine powder (80 mesh sieve); extracting Ginseng radix, Polygoni Multiflori radix, semen Cassiae, and Aloe with alcohol; adding 50% ethanol 10+8 times of the amount of the medicinal materials, and refluxing for 2 times, each time for 1.5 hr; adding 8 times of water into the medlar, soaking for 1 hour, decocting for 1.5 hours, adding 6 times of water, and decocting for 1.5 hours; mixing decoctions, filtering, concentrating under reduced pressure to obtain medicinal material and water at ratio of 2: 1, mixing with the reflux liquid, adjusting alcohol to 60%, cold precipitating for 24 hr, vacuum filtering, concentrating under reduced pressure to obtain extract, adding colla Corii Asini powder and adjuvant, granulating, drying, granulating, and packaging to obtain granule.

The method for measuring the active ingredients comprises the following steps:

method for measuring ginsenoside

Preparation of control solutions: accurately weighing ginsenoside Rg₁Adding methanol to appropriate amount of Re reference substances to obtain ginsenoside Rg contained in 1ml₁0.5mg and 0.4mg of ginsenoside Re0.4mg as reference solutions;

preparation of a test solution: pulverizing the content of the product, precisely weighing about 1.0g, dissolving in water, filtering, extracting with water saturated n-butanol for 4 times, washing the extractive solution with sodium hydroxide solution twice, evaporating n-butanol in evaporating dish, dissolving in methanol, and filtering;

chromatographic conditions are as follows: octadecylsilane chemically bonded silica is used as a filling agent;

acetonitrile-0.05% phosphoric acid solution with volume ratio of 99: 400 as mobile phase;

the detection wavelength is 203 nm;

the determination method comprises the following steps: precisely sucking 10 μ l of each of the reference solution and the sample solution, and measuring with liquid chromatograph.

Emodin determination method

Preparation of control solutions: accurately weighing emodin reference substance 5mg, placing in 50ml measuring flask, dissolving and diluting with methanol, measuring 1ml, placing in 25ml measuring flask, adding methanol to scale, and making into solution containing emodin 4 μ g per 1ml as reference solution;

preparation of a test solution: pulverizing the content of the product, precisely weighing about 1.0g, dissolving in water, filtering, evaporating to dryness, dissolving in methanol, filtering, volatilizing methanol, adding 10ml of 2.5mol/L sulfuric acid solution, ultrasonic treating for 5min, adding 10ml of chloroform, heating under reflux for 1 hr, cooling, transferring to a separating funnel, washing the container with a small amount of chloroform, adding into the separating funnel, separating the chloroform layer, extracting with chloroform, mixing the chloroform layers, dehydrating with anhydrous sodium sulfate, volatilizing the chloroform solution, precisely adding 10ml of methanol into the residue, and dissolving to obtain the final product.

Chromatographic conditions are as follows: octadecylsilane chemically bonded silica is used as a filling agent;

methanol-0.1 percent phosphoric acid solution with the volume ratio of 85: 15 is taken as a mobile phase;

the detection wavelength is 254 nm;

the determination method comprises the following steps: precisely sucking 5 μ l of each of the reference solution and the sample solution, and measuring with liquid chromatograph.

The measurement result shows that each gram of solid content contains: ginsenoside Rg₁And soap of ginsengThe total amount of glycoside Re is 1.0mg, and emodin is 50 mg.

Example 2

400 parts of polygonum multiflorum, 30 parts of cassia seed, 600 parts of aloe

150 parts of medlar, 150 parts of donkey-hide gelatin, 100 parts of ginseng

Grinding colla Corii Asini into fine powder (sieving with 80 mesh sieve); extracting Ginseng radix, Polygoni Multiflori radix, semen Cassiae and Aloe with alcohol for 3 hr for 1 time, filtering, recovering ethanol, and concentrating; adding 5 times of water into the medlar, soaking for 0.5 hour, decocting for 1 hour, adding 5 times of water, and decocting for 1 hour; mixing decoctions, filtering, concentrating under reduced pressure to obtain medicinal material and water at ratio of 3: 1, adjusting alcohol to 40%, cold precipitating for 48 hr, filtering, concentrating under reduced pressure to obtain extract, mixing with ethanol reflux extract, drying, adding colla Corii Asini powder, dextrin and sugar powder, granulating, drying, and packaging to obtain granule.

The method for measuring the active ingredients comprises the following steps: same as above

The measurement result shows that each gram of solid content contains: ginsenoside Rg₁And ginsenoside Re 1.5mg and emodin 1 mg.

Example 3

400 parts of polygonum multiflorum, 500 parts of cassia seed and 30 parts of aloe

150 parts of medlar, 150 parts of donkey-hide gelatin, 100 parts of ginseng

Grinding colla Corii Asini into fine powder (sieving with 80 mesh sieve); extracting Ginseng radix, Polygoni Multiflori radix, semen Cassiae, and Aloe with alcohol for 2 hr for 3 times, filtering, recovering ethanol, and concentrating; adding 10 times of water into medlar, soaking for 3 hours, decocting for 1.5 hours, adding 10 times of water, and decocting for 3 hours; mixing decoctions, filtering, concentrating under reduced pressure to obtain medicinal material and water at ratio of 1: 1, adjusting alcohol to 85%, cold precipitating for 12 hr, filtering, concentrating under reduced pressure to obtain extract, mixing with ethanol reflux extract, drying, adding colla Corii Asini powder and adjuvant, granulating, and encapsulating to obtain capsule.

The method for measuring the active ingredients comprises the following steps: same as above

The measurement result shows that each gram of solid content contains: ginsenoside Rg₁And ginsenoside Re 1.0mg and emodin 25 mg.

Example 4

400 parts of polygonum multiflorum, 500 parts of cassia seed and 600 parts of aloe

30 parts of medlar, 150 parts of donkey-hide gelatin and 100 parts of ginseng

Grinding colla Corii Asini into fine powder (sieving with 80 mesh sieve); extracting Ginseng radix, Polygoni Multiflori radix, semen Cassiae and Aloe with alcohol for 2 times (each time for 2 hr), filtering, recovering ethanol, and concentrating; adding 6 times of water into the medlar, soaking for 2.5 hours, decocting for 2 hours, adding 5 times of water, and decocting for 2.5 hours; mixing decoctions, filtering, concentrating under reduced pressure to obtain medicinal material and water at ratio of 1.5: 1, adjusting alcohol to 50%, cold precipitating for 36 hr, filtering, concentrating under reduced pressure to obtain extract, mixing with ethanol reflux extract, drying, adding colla Corii Asini powder and appropriate amount of adjuvants, granulating, and tabletting to obtain tablet.

The method for measuring the active ingredients comprises the following steps: same as above

The measurement result shows that each gram of solid content contains: ginsenoside Rg₁And ginsenoside Re 0.1mg and emodin 75 mg.

Example 5

400 parts of polygonum multiflorum, 500 parts of cassia seed and 600 parts of aloe

150 parts of medlar, 30 parts of donkey-hide gelatin, 100 parts of ginseng

Grinding colla Corii Asini into fine powder (80 mesh) or melting; extracting Ginseng radix, Polygoni Multiflori radix, semen Cassiae, and Aloe with alcohol for 3 times (1 hr each time), filtering, recovering ethanol, and concentrating; adding 8 times of water into the medlar, soaking for 0.5 hour, decocting for 3 hours, adding 6 times of water, and decocting for 2 hours; mixing decoctions, filtering, concentrating under reduced pressure to obtain medicinal materials and water at ratio of 2.5: 1, adjusting alcohol to 55%, cold precipitating for 48 hr, filtering, concentrating under reduced pressure to obtain extract, mixing with ethanol reflux extract, drying, adding colla Corii Asini powder and appropriate amount of starch, and making into pill.

The method for measuring the active ingredients comprises the following steps: same as above

The measurement result shows that each gram of solid content contains: ginsenoside Rg₁And ginsenoside Re 0.3mg and emodin 15 mg.

Example 6

400 parts of polygonum multiflorum, 500 parts of cassia seed and 600 parts of aloe

150 parts of medlar, 150 parts of donkey-hide gelatin, 20 parts of ginseng

Grinding colla Corii Asini into fine powder (sieving with 80 mesh sieve); extracting Ginseng radix, Polygoni Multiflori radix, semen Cassiae, and Aloe with alcohol for 2 times (2.5 hr each time), filtering, recovering ethanol, and concentrating; soaking fructus Lycii in 10 times of water for 3 hr, decocting for 1 hr, adding 8 times of water, and decocting for 1 hr; mixing decoctions, filtering, concentrating under reduced pressure to obtain medicinal material and water at ratio of 3: 1, adjusting alcohol to 60%, cold precipitating for 48 hr, filtering, concentrating under reduced pressure to obtain extract, mixing with ethanol reflux extract, drying, adding colla Corii Asini powder, mixing, and sieving to obtain powder.

The method for measuring the active ingredients comprises the following steps: same as above

The measurement result shows that each gram of solid content contains: ginsenoside Rg₁And ginsenoside Re 0.08mg and emodin 65 mg.

Example 7

25 parts of polygonum multiflorum, 500 parts of cassia seed and 600 parts of aloe

150 parts of medlar, 150 parts of donkey-hide gelatin, 100 parts of ginseng

Immature bitter orange 200 parts and white atractylodes rhizome 100 parts

Melting colla Corii Asini; extracting Ginseng radix, Polygoni Multiflori radix, semen Cassiae and Aloe with alcohol for 2 times (1.5 hr each time), filtering, recovering ethanol, and concentrating; adding 9 times of water into the medlar, the immature bitter orange and the white atractylodes rhizome, soaking for 1.5 hours, decocting for 2 hours, adding 7 times of water, and decocting for 1.5 hours; mixing decoctions, filtering, concentrating under reduced pressure to water ratio of 3: 1, adjusting alcohol to 75%, cold precipitating for 48 hr, filtering, concentrating under reduced pressure to obtain extract, mixing with ethanol reflux extract, adding colla Corii Asini powder, adding 10 times of water, stirring, cold precipitating for 48 hr, filtering, concentrating the filtrate, adjusting pH to 8, adding 0.1% active carbon, boiling for 30min, filtering, adding water for injection, filtering, fine filtering, bottling, sterilizing, and inspecting to obtain injection.

Example 8

400 parts of polygonum multiflorum, 30 parts of cassia seed, 600 parts of aloe

150 parts of medlar, 3150 parts of donkey-hide gelatin, 100 parts of ginseng

Immature bitter orange 200 parts and white atractylodes rhizome 100 parts

Melting colla Corii Asini; extracting Ginseng radix, Polygoni Multiflori radix, semen Cassiae and Aloe with alcohol for 2 times (each time for 2 hr), filtering, recovering ethanol, and concentrating; adding 8 times of water into the medlar, the immature bitter orange and the white atractylodes rhizome, soaking for 1.5 hours, decocting for 2.5 hours, adding 5 times of water, and decocting for 2 hours; mixing decoctions, filtering, concentrating under reduced pressure to water ratio of 2: 1, adjusting alcohol to 80%, cold precipitating for 48 hr, filtering, concentrating under reduced pressure to obtain extract, mixing with ethanol reflux extract, adding colla Corii Asini melted solution, adding 10 times of water, stirring, cold precipitating for 48 hr, filtering, concentrating the filtrate, adjusting pH to 4, adding 0.1% active carbon, heating and boiling for 30min, filtering, adding water for injection, filtering, fine filtering, freeze drying, aseptically packaging, and inspecting to obtain powder for injection.

Example 10

400 parts of polygonum multiflorum, 500 parts of cassia seed and 30 parts of aloe

150 parts of medlar, 150 parts of donkey-hide gelatin, 100 parts of ginseng

Immature bitter orange 200 parts and white atractylodes rhizome 100 parts

Melting colla Corii Asini; extracting Ginseng radix, Polygoni Multiflori radix, semen Cassiae, and Aloe with alcohol for 1.5 hr for 2 times, filtering, recovering ethanol, and concentrating; adding 8 times of water into the medlar, the immature bitter orange and the white atractylodes rhizome, soaking for 2.5 hours, decocting for 2 hours, adding 6 times of water, and decocting for 1.5 hours; mixing decoctions, filtering, concentrating under reduced pressure to water ratio of 3: 1, adjusting alcohol to 85%, cold precipitating for 48 hr, filtering, concentrating under reduced pressure to obtain extract, mixing with ethanol reflux extract, adding colla Corii Asini powder, melting, adding 10 times of water, cold precipitating for 48 hr, filtering, concentrating the filtrate, adjusting pH to 7, adding 0.1% active carbon, heating and boiling for 30min, filtering, adding water for injection, filtering, fine filtering, bottling, sterilizing, and inspecting to obtain infusion.

Example 11

400 parts of polygonum multiflorum, 500 parts of cassia seed and 600 parts of aloe

30 parts of medlar, 150 parts of donkey-hide gelatin and 100 parts of ginseng

Immature bitter orange 200 parts and white atractylodes rhizome 100 parts

Melting colla Corii Asini; extracting Ginseng radix, Polygoni Multiflori radix, semen Cassiae and Aloe with alcohol for 2 times (each time for 2 hr), filtering, recovering ethanol, and concentrating; adding 10 times of water into the medlar, the immature bitter orange and the white atractylodes rhizome, soaking for 0.5 hour, decocting for 2 hours, adding 8 times of water, and decocting for 1.5 hours; mixing decoctions, filtering, concentrating under reduced pressure to water ratio of 3: 1, adjusting ethanol to 65%, cold precipitating for 36 hr, filtering, concentrating under reduced pressure to obtain extract, mixing with ethanol reflux extract, adding colla Corii Asini powder, melting, adding ethanol with specified concentration, stirring, and filtering to obtain tincture.

Example 12

400 parts of polygonum multiflorum, 500 parts of cassia seed and 600 parts of aloe

150 parts of medlar, 30 parts of donkey-hide gelatin, 100 parts of ginseng

Immature bitter orange 200 parts and white atractylodes rhizome 100 parts

Grinding colla Corii Asini into fine powder (sieving with 80 mesh sieve); extracting Ginseng radix, Polygoni Multiflori radix, semen Cassiae, and Aloe with alcohol for 2 times (1.5 hr each time), filtering, recovering ethanol, and concentrating; adding 8 times of water into the medlar, the immature bitter orange and the white atractylodes rhizome, soaking for 1 hour, decocting for 3 hours, adding 6 times of water, and decocting for 3 hours; mixing decoctions, filtering, concentrating under reduced pressure to water ratio of 1: 1, adjusting alcohol to 80%, cold precipitating for 48 hr, filtering, concentrating under reduced pressure to obtain extract, mixing with ethanol reflux extract, drying, adding colla Corii Asini powder, mixing, heating to melt matrix, adding dried powder, mixing, pouring into suppository coated with release agent, cooling, and taking out to obtain suppository.

Example 13

400 parts of polygonum multiflorum, 500 parts of cassia seed and 600 parts of aloe

150 parts of medlar, 150 parts of donkey-hide gelatin, 20 parts of ginseng

Immature bitter orange 200 parts and white atractylodes rhizome 100 parts

Melting colla Corii Asini; extracting Ginseng radix, Polygoni Multiflori radix, semen Cassiae, and Aloe with alcohol for 2 times, filtering the medicinal liquid, recovering ethanol, and concentrating; adding 10 times of water into the medlar, the immature bitter orange and the white atractylodes rhizome, soaking for 2 hours, decocting for 2 hours, adding 8 times of water, and decocting for 2 hours; mixing decoctions, filtering, concentrating under reduced pressure to water ratio of 2: 1, adjusting ethanol to 50%, cold precipitating for 12 hr, filtering, concentrating under reduced pressure to obtain extract, mixing with ethanol reflux extract, adding colla Corii Asini powder, melting, adding water, filtering, adding sucrose, boiling, dissolving, filtering, concentrating to obtain syrup, mixing with the above concentrated solution, boiling, cooling, adding antiseptic and essence, and diluting with water to obtain syrup.

Example 14

400 parts of polygonum multiflorum, 500 parts of cassia seed and 600 parts of aloe

150 parts of medlar, 150 parts of donkey-hide gelatin, 100 parts of ginseng

50 parts of immature bitter orange and 100 parts of bighead atractylodes rhizome

Melting colla Corii Asini; extracting Ginseng radix, Polygoni Multiflori radix, semen Cassiae, and Aloe with alcohol for 2 times (1.5 hr each time), filtering, recovering ethanol, and concentrating; adding 8 times of water into the medlar, the immature bitter orange and the white atractylodes rhizome, soaking for 1 hour, decocting for 1.5 hours, adding 6 times of water, and decocting for 1.5 hours; mixing decoctions, filtering, concentrating under reduced pressure to water ratio of 3: 1, adjusting ethanol to 65%, cold precipitating for 48 hr, filtering, concentrating under reduced pressure to obtain extract, mixing with ethanol reflux extract, adding appropriate amount of colla Corii Asini solution, adding water, filtering, bottling, and sterilizing to obtain mixture.

Example 15

400 parts of polygonum multiflorum, 500 parts of cassia seed and 600 parts of aloe

150 parts of medlar, 150 parts of donkey-hide gelatin, 100 parts of ginseng

Immature bitter orange 200 parts and white atractylodes rhizome 20 parts

Grinding colla Corii Asini into fine powder (sieving with 80 mesh sieve); extracting Ginseng radix, Polygoni Multiflori radix, semen Cassiae, and Aloe with alcohol for 2 times (1.5 hr each time), filtering, recovering ethanol, and concentrating; adding 8 times of water into the medlar, the immature bitter orange and the white atractylodes rhizome, soaking for 2.5 hours, decocting for 2 hours, adding 6 times of water, and decocting for 2 hours; mixing decoctions, filtering, concentrating under reduced pressure to obtain medicinal material and water at ratio of 3: 1, adjusting alcohol to 55%, cold precipitating for 12 hr, filtering, concentrating under reduced pressure to obtain extract, mixing with ethanol reflux extract, drying, adding colla Corii Asini powder, mixing, adding dextrin, magnesium stearate and stevioside, and granulating with dry granulating machine.

Example 16

60 parts of polygonum multiflorum, 180 parts of cassia seed and 200 parts of aloe

100 parts of medlar, 100 parts of donkey-hide gelatin, 80 parts of ginseng

Immature bitter orange 150 parts and bighead atractylodes rhizome 80 parts.

Grinding colla Corii Asini into fine powder (sieving with 80 mesh sieve); extracting Ginseng radix, Polygoni Multiflori radix, semen Cassiae, and Aloe with alcohol for 2 times (1.5 hr each time), filtering, recovering ethanol, and concentrating; adding 8 times of water into the medlar, the immature bitter orange and the white atractylodes rhizome, soaking for 2.5 hours, decocting for 2 hours, adding 6 times of water, and decocting for 2 hours; mixing decoctions, filtering, concentrating under reduced pressure to obtain medicinal material and water at ratio of 3: 1, adjusting alcohol to 55%, cold precipitating for 12 hr, filtering, concentrating under reduced pressure to obtain extract, mixing with ethanol reflux extract, drying, adding colla Corii Asini powder, mixing, adding dextrin, magnesium stearate and stevioside, and granulating with dry granulating machine.

Example 17

150 parts of polygonum multiflorum, 80 parts of cassia seed and 200 parts of aloe

100 parts of medlar, 100 parts of donkey-hide gelatin, 80 parts of ginseng

Immature bitter orange 150 parts and bighead atractylodes rhizome 80 parts.

Grinding colla Corii Asini into fine powder (sieving with 80 mesh sieve); extracting Ginseng radix, Polygoni Multiflori radix, semen Cassiae, and Aloe with alcohol for 2 times (1.5 hr each time), filtering, recovering ethanol, and concentrating; adding 8 times of water into the medlar, the immature bitter orange and the white atractylodes rhizome, soaking for 2.5 hours, decocting for 2 hours, adding 6 times of water, and decocting for 2 hours; mixing decoctions, filtering, concentrating under reduced pressure to water ratio of 3: 1, adjusting alcohol to 55%, cold precipitating for 12 hr, filtering, concentrating under reduced pressure to obtain extract, mixing with ethanol reflux extract, drying, adding colla Corii Asini powder, mixing above fine powder with dextrin and sugar powder, granulating, drying, and packaging to obtain granule.

Example 18

150 parts of polygonum multiflorum, 180 parts of cassia seed and 100 parts of aloe

100 parts of medlar, 100 parts of donkey-hide gelatin, 80 parts of ginseng

Immature bitter orange 150 parts and bighead atractylodes rhizome 80 parts.

Grinding colla Corii Asini into fine powder (sieving with 80 mesh sieve); extracting Ginseng radix, Polygoni Multiflori radix, semen Cassiae, and Aloe with alcohol for 2 times (2.5 hr each time), filtering, recovering ethanol, and concentrating; soaking fructus Lycii in 10 times of water for 3 hr, decocting for 1 hr, adding 8 times of water, and decocting for 1 hr; mixing decoctions, filtering, concentrating under reduced pressure to water ratio of 1: 1, adjusting alcohol to 60%, cold precipitating for 48 hr, filtering, concentrating under reduced pressure to obtain extract, mixing with ethanol reflux extract, drying, adding colla Corii Asini powder dextrin, mixing with 65% ethanol, granulating, drying, and packaging.

Example 19

150 parts of polygonum multiflorum, 180 parts of cassia seed and 200 parts of aloe

30 parts of medlar, 100 parts of donkey-hide gelatin and 80 parts of ginseng

Immature bitter orange 150 parts and bighead atractylodes rhizome 80 parts.

Grinding colla Corii Asini into fine powder (sieving with 80 mesh sieve); extracting Ginseng radix, Polygoni Multiflori radix, semen Cassiae, and Aloe with alcohol for 2 times (2.5 hr each time), filtering, recovering ethanol, and concentrating; soaking fructus Lycii in 10 times of water for 3 hr, decocting for 1 hr, adding 8 times of water, and decocting for 1 hr; mixing decoctions, filtering, concentrating under reduced pressure to water ratio of 1: 1, adjusting alcohol to 60%, cold precipitating for 48 hr, filtering, concentrating under reduced pressure to obtain extract, mixing with ethanol reflux extract, drying, adding colla Corii Asini powder dextrin, mixing with 65% ethanol, granulating, drying, making into capsule, and packaging.

Example 20

150 parts of polygonum multiflorum, 180 parts of cassia seed and 200 parts of aloe

100 parts of medlar, 30 parts of donkey-hide gelatin, 80 parts of ginseng

Immature bitter orange 150 parts and bighead atractylodes rhizome 80 parts.

Grinding colla Corii Asini into fine powder (sieving with 80 mesh sieve); extracting Ginseng radix, Polygoni Multiflori radix, semen Cassiae, and Aloe with alcohol for 2 times (1.5 hr each time), filtering, recovering ethanol, and concentrating; adding 8 times of water into the medlar, the immature bitter orange and the white atractylodes rhizome, soaking for 2.5 hours, decocting for 2 hours, adding 6 times of water, and decocting for 2 hours; mixing decoctions, filtering, concentrating under reduced pressure to water ratio of 3: 1, adjusting alcohol to 55%, cold precipitating for 12 hr, filtering, concentrating under reduced pressure to obtain extract, mixing with ethanol reflux extract, drying, adding colla Corii Asini powder, mixing, granulating with dry granulating machine, encapsulating, and packaging.

Example 21

150 parts of polygonum multiflorum, 180 parts of cassia seed and 200 parts of aloe

100 parts of medlar, 100 parts of donkey-hide gelatin, 20 parts of ginseng

Immature bitter orange 150 parts and bighead atractylodes rhizome 80 parts.

Grinding colla Corii Asini into fine powder (sieving with 80 mesh sieve); extracting Ginseng radix, Polygoni Multiflori radix, semen Cassiae, and Aloe with alcohol for 2 times (1.5 hr each time), filtering, recovering ethanol, and concentrating; adding 8 times of water into the medlar, the immature bitter orange and the white atractylodes rhizome, soaking for 2.5 hours, decocting for 2 hours, adding 6 times of water, and decocting for 2 hours; mixing decoctions, filtering, concentrating under reduced pressure to water ratio of 3: 1, adjusting alcohol to 55%, cold precipitating for 12 hr, filtering, concentrating under reduced pressure to obtain extract, mixing with ethanol reflux extract, drying, adding colla Corii Asini powder, mixing, granulating with dry granulating machine, encapsulating, and packaging.

Example 22

150 parts of polygonum multiflorum, 180 parts of cassia seed and 200 parts of aloe

100 parts of medlar, 100 parts of donkey-hide gelatin, 80 parts of ginseng

80 parts of immature bitter orange and 80 parts of bighead atractylodes rhizome.

Grinding colla Corii Asini into fine powder (sieving with 80 mesh sieve); extracting Ginseng radix, Polygoni Multiflori radix, semen Cassiae, and Aloe with alcohol for 2 times (1.5 hr each time), filtering, recovering ethanol, and concentrating; adding 8 times of water into the medlar, the immature bitter orange and the white atractylodes rhizome, soaking for 2.5 hours, decocting for 2 hours, adding 6 times of water, and decocting for 2 hours; mixing decoctions, filtering, concentrating under reduced pressure to obtain medicinal material and water at ratio of 0.8: 1, adjusting alcohol to 55%, cold precipitating for 12 hr, filtering, concentrating under reduced pressure to obtain extract, mixing with ethanol reflux extract, drying, adding colla Corii Asini powder, mixing, adding dextrin, magnesium stearate and stevioside, granulating with dry granulating machine, encapsulating, and packaging.

Example 23

150 parts of polygonum multiflorum, 180 parts of cassia seed and 200 parts of aloe

100 parts of medlar, 100 parts of donkey-hide gelatin, 80 parts of ginseng

Immature bitter orange 150 parts and bighead atractylodes rhizome 20 parts.

Grinding colla Corii Asini into fine powder (sieving with 80 mesh sieve); extracting Ginseng radix, Polygoni Multiflori radix, semen Cassiae, and Aloe with alcohol for 2 times (1.5 hr each time), filtering, recovering ethanol, and concentrating; adding 8 times of water into the medlar, the immature bitter orange and the white atractylodes rhizome, soaking for 2.5 hours, decocting for 2 hours, adding 6 times of water, and decocting for 2 hours; mixing decoctions, filtering, concentrating under reduced pressure to water ratio of 1: 1, adjusting alcohol to 55%, cold precipitating for 12 hr, filtering, concentrating under reduced pressure to obtain extract, mixing with ethanol reflux extract, drying, adding colla Corii Asini powder, mixing, granulating with dry granulating machine, encapsulating, and packaging.

Example 24

80 parts of polygonum multiflorum, 150 parts of cassia seed and 160 parts of aloe

80 parts of medlar, 80 parts of donkey-hide gelatin, 50 parts of ginseng

120 parts of immature bitter orange and 50 parts of bighead atractylodes rhizome.

Grinding colla Corii Asini into fine powder (sieving with 80 mesh sieve); extracting Ginseng radix, Polygoni Multiflori radix, semen Cassiae, and Aloe with alcohol for 2 times (1.5 hr each time), filtering, recovering ethanol, and concentrating; adding 8 times of water into the medlar, the immature bitter orange and the white atractylodes rhizome, soaking for 2.5 hours, decocting for 2 hours, adding 6 times of water, and decocting for 2 hours; mixing decoctions, filtering, concentrating under reduced pressure to water ratio of 1: 1, adjusting alcohol to 55%, cold precipitating for 12 hr, filtering, concentrating under reduced pressure to obtain extract, mixing with ethanol reflux extract, drying, adding colla Corii Asini powder, mixing, granulating with dry granulating machine, encapsulating, and packaging.

Example 25

120 parts of polygonum multiflorum, 100 parts of cassia seed and 160 parts of aloe

80 parts of medlar, 80 parts of donkey-hide gelatin, 50 parts of ginseng

120 parts of immature bitter orange and 50 parts of bighead atractylodes rhizome.

Grinding colla Corii Asini into fine powder (sieving with 80 mesh sieve); extracting Ginseng radix, Polygoni Multiflori radix, semen Cassiae, and Aloe with alcohol for 2 times (1.5 hr each time), filtering, recovering ethanol, and concentrating; adding 8 times of water into the medlar, the immature bitter orange and the white atractylodes rhizome, soaking for 2.5 hours, decocting for 2 hours, adding 6 times of water, and decocting for 2 hours; mixing decoctions, filtering, concentrating under reduced pressure to water ratio of 1: 1, adjusting alcohol to 55%, cold precipitating for 12 hr, filtering, concentrating under reduced pressure to obtain extract, mixing with ethanol reflux extract, drying, adding colla Corii Asini powder, mixing, granulating with dry granulating machine, encapsulating, and packaging.

Example 26

120 parts of polygonum multiflorum, 150 parts of cassia seed and 160 parts of aloe

80 parts of medlar, 40 parts of donkey-hide gelatin, 50 parts of ginseng

120 parts of immature bitter orange and 50 parts of bighead atractylodes rhizome.

Grinding colla Corii Asini into fine powder (sieving with 80 mesh sieve); extracting Ginseng radix, Polygoni Multiflori radix, semen Cassiae, and Aloe with alcohol for 2 times (1.5 hr each time), filtering, recovering ethanol, and concentrating; adding 8 times of water into the medlar, the immature bitter orange and the white atractylodes rhizome, soaking for 2.5 hours, decocting for 2 hours, adding 6 times of water, and decocting for 2 hours; mixing decoctions, filtering, concentrating under reduced pressure to water ratio of 1: 1, adjusting alcohol to 55%, cold precipitating for 12 hr, filtering, concentrating under reduced pressure to obtain extract, mixing with ethanol reflux extract, drying, adding colla Corii Asini powder, mixing, granulating with dry granulating machine, encapsulating, and packaging.

Example 27

120 parts of polygonum multiflorum, 150 parts of cassia seed and 160 parts of aloe

80 parts of medlar, 80 parts of donkey-hide gelatin, 20 parts of ginseng

120 parts of immature bitter orange and 50 parts of bighead atractylodes rhizome.

Grinding colla Corii Asini into fine powder (sieving with 80 mesh sieve); extracting Ginseng radix, Polygoni Multiflori radix, semen Cassiae, and Aloe with alcohol for 2 times (1.5 hr each time), filtering, recovering ethanol, and concentrating; adding 8 times of water into the medlar, the immature bitter orange and the white atractylodes rhizome, soaking for 2.5 hours, decocting for 2 hours, adding 6 times of water, and decocting for 2 hours; mixing decoctions, filtering, concentrating under reduced pressure to water ratio of 1: 1, adjusting alcohol to 55%, cold precipitating for 12 hr, filtering, concentrating under reduced pressure to obtain extract, mixing with ethanol reflux extract, drying, adding colla Corii Asini powder, mixing, granulating with dry granulating machine, encapsulating, and packaging.

Example 28

120 parts of polygonum multiflorum, 150 parts of cassia seed and 160 parts of aloe

80 parts of medlar, 80 parts of donkey-hide gelatin, 50 parts of ginseng

Immature bitter orange 120 parts and white atractylodes rhizome 30 parts

Grinding colla Corii Asini into fine powder (sieving with 80 mesh sieve); extracting Ginseng radix, Polygoni Multiflori radix, semen Cassiae, and Aloe with alcohol for 2 times (1.5 hr each time), filtering, recovering ethanol, and concentrating; adding 8 times of water into the medlar, the immature bitter orange and the white atractylodes rhizome, soaking for 2.5 hours, decocting for 2 hours, adding 6 times of water, and decocting for 2 hours; mixing decoctions, filtering, concentrating under reduced pressure to water ratio of 1: 1, adjusting alcohol to 55%, cold precipitating for 12 hr, filtering, concentrating under reduced pressure to obtain extract, mixing with ethanol reflux extract, drying, adding colla Corii Asini powder, mixing, granulating with dry granulating machine, encapsulating, and packaging.

Example 29

100 parts of polygonum multiflorum, 120 parts of cassia seed and 130 parts of aloe

65 parts of medlar, 60 parts of donkey-hide gelatin, 30 parts of ginseng

Radix aucklandiae 90 parts

Adding 8 times of water into radix aucklandiae, soaking for 2 hr, steam distilling for 5 hr, collecting volatile oil, and grinding colla Corii Asini into fine powder (sieving with 80 mesh sieve); extracting Ginseng radix, Polygoni Multiflori radix, semen Cassiae, and Aloe with alcohol for 2 times (1.5 hr each time), filtering, recovering ethanol, and concentrating; adding 8 times of water into the residue after oil extraction of fructus Lycii and radix aucklandiae, soaking for 2.5 hr, decocting for 2 hr, adding 6 times of water, and decocting for 2 hr; mixing decoctions, filtering, concentrating under reduced pressure to water ratio of 1: 1, adjusting alcohol to 55%, cold precipitating for 12 hr, filtering, concentrating under reduced pressure to obtain extract, mixing with ethanol reflux extract, drying, adding colla Corii Asini powder, mixing, granulating with dry granulating machine, encapsulating, and packaging.

Example 30

100 parts of polygonum multiflorum, 120 parts of cassia seed and 130 parts of aloe

65 parts of medlar, 60 parts of donkey-hide gelatin, 30 parts of ginseng

Radix aucklandiae 90 parts and Atractylodis rhizoma 30 parts

Adding 8 times of water into radix aucklandiae, soaking for 2 hr, steam distilling for 5 hr, collecting volatile oil, and grinding colla Corii Asini into fine powder (sieving with 80 mesh sieve); extracting Ginseng radix, Polygoni Multiflori radix, semen Cassiae, and Aloe with alcohol for 2 times (1.5 hr each time), filtering, recovering ethanol, and concentrating; adding 8 times of water into the dregs of the decoction after extracting oil from the medlar, the largehead atractylodes rhizome and the costustoot, soaking for 2.5 hours, decocting for 2 hours, adding 6 times of water, and decocting for 2 hours; mixing decoctions, filtering, concentrating under reduced pressure to water ratio of 1: 1, adjusting alcohol to 55%, cold precipitating for 12 hr, filtering, concentrating under reduced pressure to obtain extract, mixing with ethanol reflux extract, drying, adding colla Corii Asini powder, mixing, granulating with dry granulating machine, encapsulating, and packaging.

Example 31

100 parts of polygonum multiflorum, 120 parts of cassia seed and 130 parts of aloe

65 parts of medlar, 60 parts of donkey-hide gelatin, 30 parts of ginseng

120 parts of immature bitter orange and 30 parts of costustoot

Adding 8 times of water into radix aucklandiae, soaking for 2 hr, steam distilling for 5 hr, collecting volatile oil, and grinding colla Corii Asini into fine powder (sieving with 80 mesh sieve); extracting Ginseng radix, Polygoni Multiflori radix, semen Cassiae, and Aloe with alcohol for 2 times (1.5 hr each time), filtering, recovering ethanol, and concentrating; adding 8 times of water into the dregs of the decoction after extracting oil from the medlar, the largehead atractylodes rhizome and the costustoot, soaking for 2.5 hours, decocting for 2 hours, adding 6 times of water, and decocting for 2 hours; mixing decoctions, filtering, concentrating under reduced pressure to water ratio of 1: 1, adjusting alcohol to 55%, cold precipitating for 12 hr, filtering, concentrating under reduced pressure to obtain extract, mixing with ethanol reflux extract, drying, adding colla Corii Asini powder, mixing, granulating with dry granulating machine, encapsulating, and packaging.

Example 32

120 parts of polygonum multiflorum, 150 parts of cassia seed and 160 parts of aloe

80 parts of medlar, 80 parts of angelica and 50 parts of ginseng

Immature bitter orange 120 parts and white atractylodes rhizome 30 parts

Adding 8 times of water into the angelica, soaking for 2 hours, distilling for 5 hours by steam, and collecting volatile oil for later use; extracting Ginseng radix, Polygoni Multiflori radix, semen Cassiae, and Aloe with alcohol for 2 times (1.5 hr each time), filtering, recovering ethanol, and concentrating; adding 8 times of water into the residues after oil extraction of the barbary wolfberry fruit, the immature bitter orange, the largehead atractylodes rhizome and the Chinese angelica, soaking for 2.5 hours, decocting for 2 hours, adding 6 times of water, and decocting for 2 hours; mixing decoctions, filtering, concentrating under reduced pressure to water ratio of 1: 1, adjusting alcohol to 55%, cold precipitating for 12 hr, filtering, concentrating under reduced pressure to obtain extract, mixing with ethanol reflux extract, drying, adding colla Corii Asini powder, mixing, granulating with dry granulating machine, encapsulating, and packaging.

Example 33

120 parts of rhubarb, 150 parts of cassia seed and 160 parts of aloe

80 parts of medlar, 80 parts of donkey-hide gelatin, 50 parts of ginseng

Immature bitter orange 120 parts and white atractylodes rhizome 30 parts

Grinding colla Corii Asini into fine powder (sieving with 80 mesh sieve); extracting Ginseng radix, radix et rhizoma Rhei, semen Cassiae, and Aloe with alcohol for 2 times (1.5 hr each time), filtering, recovering ethanol, and concentrating; adding 8 times of water into the medlar, the immature bitter orange and the white atractylodes rhizome, soaking for 2.5 hours, decocting for 2 hours, adding 6 times of water, and decocting for 2 hours; mixing decoctions, filtering, concentrating under reduced pressure to water ratio of 1: 1, adjusting alcohol to 55%, cold precipitating for 12 hr, filtering, concentrating under reduced pressure to obtain extract, mixing with ethanol reflux extract, drying, adding colla Corii Asini powder, mixing, granulating with dry granulating machine, encapsulating, and packaging to obtain the final product

Example 34

Radix Polygoni Multiflori 120 parts, radix Et rhizoma Rhei 150 parts, Aloe 160 parts

80 parts of medlar, 80 parts of donkey-hide gelatin, 50 parts of ginseng

Immature bitter orange 120 parts and white atractylodes rhizome 30 parts

Grinding colla Corii Asini into fine powder (sieving with 80 mesh sieve); extracting Ginseng radix, Polygoni Multiflori radix, radix et rhizoma Rhei, and Aloe with alcohol for 2 times (1.5 hr each time), filtering, recovering ethanol, and concentrating; adding 8 times of water into the medlar, the immature bitter orange and the white atractylodes rhizome, soaking for 2.5 hours, decocting for 2 hours, adding 6 times of water, and decocting for 2 hours; mixing decoctions, filtering, concentrating under reduced pressure to water ratio of 1: 1, adjusting alcohol to 55%, cold precipitating for 12 hr, filtering, concentrating under reduced pressure to obtain extract, mixing with ethanol reflux extract, drying, adding colla Corii Asini powder, mixing, granulating with dry granulating machine, encapsulating, and packaging.

Example 35

120 parts of fleece-flower root, 150 parts of cassia seed, 160 parts of rhubarb

80 parts of medlar, 80 parts of donkey-hide gelatin, 50 parts of ginseng

Immature bitter orange 120 parts and white atractylodes rhizome 30 parts

Grinding colla Corii Asini into fine powder (sieving with 80 mesh sieve); extracting Ginseng radix, Polygoni Multiflori radix, semen Cassiae, and radix et rhizoma Rhei with alcohol for 2 times (1.5 hr each time), filtering, recovering ethanol, and concentrating; adding 8 times of water into the medlar, the immature bitter orange and the white atractylodes rhizome, soaking for 2.5 hours, decocting for 2 hours, adding 6 times of water, and decocting for 2 hours; mixing decoctions, filtering, concentrating under reduced pressure to water ratio of 1: 1, adjusting alcohol to 55%, cold precipitating for 12 hr, filtering, concentrating under reduced pressure to obtain extract, mixing with ethanol reflux extract, drying, adding colla Corii Asini powder, mixing, granulating with dry granulating machine, encapsulating, and packaging.

Example 36

120 parts of rhubarb, 30 parts of white atractylodes rhizome and 160 parts of aloe

80 parts of medlar, 80 parts of donkey-hide gelatin, 50 parts of ginseng

Immature bitter orange 120 parts

Grinding colla Corii Asini into fine powder (sieving with 80 mesh sieve); extracting Ginseng radix, radix et rhizoma Rhei, and Aloe with alcohol for 2 times (1.5 hr each time), filtering, recovering ethanol, and concentrating; adding 8 times of water into the medlar, the immature bitter orange and the white atractylodes rhizome, soaking for 2.5 hours, decocting for 2 hours, adding 6 times of water, and decocting for 2 hours; mixing decoctions, filtering, concentrating under reduced pressure to water ratio of 1: 1, adjusting alcohol to 55%, cold precipitating for 12 hr, filtering, concentrating under reduced pressure to obtain extract, mixing with ethanol reflux extract, drying, adding colla Corii Asini powder, mixing, granulating with dry granulating machine, encapsulating, and packaging.

Example 37

Radix Polygoni Multiflori 120 parts, radix Et rhizoma Rhei 150 parts, rhizoma Atractylodis Macrocephalae 30 parts

80 parts of medlar, 80 parts of donkey-hide gelatin, 50 parts of ginseng

Immature bitter orange 120 parts

Grinding colla Corii Asini into fine powder (sieving with 80 mesh sieve); extracting Ginseng radix, Polygoni Multiflori radix, and radix et rhizoma Rhei with alcohol for 2 times, each time for 1.5 hr, filtering the medicinal liquid, recovering ethanol, and concentrating; adding 8 times of water into the medlar, the immature bitter orange and the white atractylodes rhizome, soaking for 2.5 hours, decocting for 2 hours, adding 6 times of water, and decocting for 2 hours; mixing decoctions, filtering, concentrating under reduced pressure to water ratio of 1: 1, adjusting alcohol to 55%, cold precipitating for 12 hr, filtering, concentrating under reduced pressure to obtain extract, mixing with ethanol reflux extract, drying, adding colla Corii Asini powder, mixing, granulating with dry granulating machine, encapsulating, and packaging.

Example 38

120 parts of rhubarb, 150 parts of cassia seed and 30 parts of bighead atractylodes rhizome

80 parts of medlar, 80 parts of donkey-hide gelatin, 50 parts of ginseng

Immature bitter orange 120 parts

Grinding colla Corii Asini into fine powder (sieving with 80 mesh sieve); extracting Ginseng radix, semen Cassiae, and radix et rhizoma Rhei with alcohol for 2 times, 1.5 hr each time, filtering medicinal liquid, recovering ethanol, and concentrating; adding 8 times of water into the medlar, the immature bitter orange and the white atractylodes rhizome, soaking for 2.5 hours, decocting for 2 hours, adding 6 times of water, and decocting for 2 hours; mixing decoctions, filtering, concentrating under reduced pressure to water ratio of 1: 1, adjusting alcohol to 55%, cold precipitating for 12 hr, filtering, concentrating under reduced pressure to obtain extract, mixing with ethanol reflux extract, drying, adding colla Corii Asini powder, mixing, granulating with dry granulating machine, encapsulating, and packaging.

Example 39

120 parts of rhubarb, 120 parts of immature bitter orange and 30 parts of bighead atractylodes rhizome

80 parts of medlar, 80 parts of donkey-hide gelatin, 50 parts of ginseng

Grinding colla Corii Asini into fine powder (sieving with 80 mesh sieve); extracting Ginseng radix, semen Cassiae, and radix et rhizoma Rhei with alcohol for 2 times, 1.5 hr each time, filtering medicinal liquid, recovering ethanol, and concentrating; adding 8 times of water into the medlar, the immature bitter orange and the white atractylodes rhizome, soaking for 2.5 hours, decocting for 2 hours, adding 6 times of water, and decocting for 2 hours; mixing decoctions, filtering, concentrating under reduced pressure to water ratio of 1: 1, adjusting alcohol to 55%, cold precipitating for 12 hr, filtering, concentrating under reduced pressure to obtain extract, mixing with ethanol reflux extract, drying, adding colla Corii Asini powder, mixing, granulating with dry granulating machine, encapsulating, and packaging.

Claims (9)

1. A traditional Chinese medicine composition with functions of relaxing bowels, expelling toxin, losing weight and reducing fat is characterized by being prepared from the following raw materials in parts by weight:

25-400 parts of polygonum multiflorum, 30-500 parts of cassia seed, 30-600 parts of aloe

30-150 parts of medlar, 30-150 parts of donkey-hide gelatin, 20-100 parts of ginseng.

2. The composition according to claim 1, characterized in that it further comprises:

50-200 parts of immature bitter orange and 20-100 parts of bighead atractylodes rhizome.

3. The composition according to claim 2, wherein the weight ratio of the raw materials is:

60-150 parts of polygonum multiflorum, 80-180 parts of cassia seed, 100 parts of aloe and 200 parts of aloe

30-100 parts of medlar, 30-100 parts of donkey-hide gelatin, 20-80 parts of ginseng

80-150 parts of immature bitter orange and 20-80 parts of bighead atractylodes rhizome.

4. The composition according to claim 3, wherein the weight ratio of the raw materials is:

80-120 parts of polygonum multiflorum, 100 parts of cassia seed, 150 parts of aloe and 160 parts of aloe

50-80 parts of medlar, 40-80 parts of donkey-hide gelatin, 20-50 parts of ginseng

80-120 parts of immature bitter orange and 30-50 parts of bighead atractylodes rhizome.

5. The Chinese medicinal composition according to any one of claims 1 to 4, wherein the Chinese medicinal composition is prepared into any clinically acceptable dosage form.

6. The composition of claim 5, wherein the dosage form of the composition is capsule, tablet or granule.

7. The Chinese medicinal composition according to claim 6, wherein each gram of the Chinese medicinal composition comprises: ginsenoside Rg₁And ginsenoside Re of 0.08-1.5 mg.

8. The Chinese medicinal composition according to claim 7, wherein the determination method of the effective component ginsenoside comprises the following steps:

of control solutionsPreparation: accurately weighing ginsenoside Rg₁Adding methanol to appropriate amount of Re reference substances to obtain ginsenoside Rg contained in 1ml₁0.5mg and 0.4mg of ginsenoside Re0.4mg as reference solutions;

preparation of a test solution: pulverizing the product, collecting 1.0g, accurately weighing, dissolving in water, filtering, extracting with water saturated n-butanol for 4 times, washing the extractive solution with sodium hydroxide solution twice, evaporating n-butanol in evaporating dish, dissolving in methanol, and filtering;

chromatographic conditions are as follows: octadecylsilane chemically bonded silica is used as a filling agent;

acetonitrile-0.05% phosphoric acid solution with volume ratio of 99: 400 as mobile phase;

the detection wavelength is 203 nm;

the determination method comprises the following steps: precisely sucking 10 μ l of each of the reference solution and the sample solution, and measuring with liquid chromatograph;

9. the Chinese medicinal composition according to claim 1, 2, 3 or 4, characterized in that it is prepared according to the following method: grinding colla Corii Asini into fine powder, sieving with 80 mesh sieve or melting; extracting Ginseng radix, Polygoni Multiflori radix, semen Cassiae and Aloe with alcohol, refluxing with 40-80% ethanol for 1-3 times, each for 1-3 hr, filtering, recovering ethanol, and concentrating; adding 5-10 times of water into the medlar, the immature bitter orange and the white atractylodes rhizome, soaking for 0.5-3 hours, decocting for 1-3 hours, adding 5-10 times of water, and decocting for 1-3 hours; mixing decoctions, filtering, concentrating under reduced pressure to water ratio of 1: 1-3: 1, adjusting alcohol to 40% -85%, cold precipitating for 12-48 hr, filtering, concentrating under reduced pressure to obtain extract, mixing with the ethanol reflux extract or drying, adding colla Corii Asini powder or melted solution and adjuvant, and making into clinically acceptable dosage forms by conventional preparation method.