CN1201797C - Medicine for treating gastritis and preparation process thereof - Google Patents
Medicine for treating gastritis and preparation process thereof Download PDFInfo
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- CN1201797C CN1201797C CNB031173209A CN03117320A CN1201797C CN 1201797 C CN1201797 C CN 1201797C CN B031173209 A CNB031173209 A CN B031173209A CN 03117320 A CN03117320 A CN 03117320A CN 1201797 C CN1201797 C CN 1201797C
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Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The present invention discloses a medicine for treating gastritis, which at least contains raw medicinal materials of green tangerine peel and nutgrass flatsedge. The present invention is prepared according to certain weight proportion, wherein the raw medicinal materials also comprise costustoot, officinal magnolia bark, jiuxiang bug, medcinal evodia fruit, heterophylly falsestarwort root, atractylodes rhizome, Chinese fevervine herb, yanhusuo and coptis root which are made into the present invention by preparation according to the weight proportion. In addition, the present invention also discloses a preparation method of the medicine. The medicine of the present invention has the functions of liver clearing, spleen strengthening, middle warmer regulation and pain alleviation. The present invention is used for treating gastritis.
Description
Technical field
The present invention relates to a kind of medicine for the treatment of gastritis and preparation method thereof, specifically, be a kind of Chinese medicine preparation and preparation method thereof.
Background technology
Gastric abscess claims stomachache again, is meant that the nearly pit of the stomach of gastral cavilty place pain is the disease of primary symptom.This disease is occupied extremely important status in internal disease, its morbidity is extensive, and the men and women all can suffer from blue or green lacking, and is clinical commonly encountered diseases, frequently-occurring disease.Divide by TCM Syndrome Type, single person is less for the card feelings, and the overwhelming majority is compound card, and the wet resistance of holding concurrently with deficiency and coldness especially, stagnation of QI person are many; Disease by doctor trained in Western medicine is divided, and chronic superficial gastritis is maximum.Because the develop rapidly of gastroscope technology, binding of pathological is learned biopsy, and is very easy to the diagnosis of chronic superficial gastritis, yet still lacks reliable means in treatment.At present, can be in order to the existing many kinds of the Chinese patent medicine of treatment chronic superficial gastritis, as the Lignum Aquilariae Resinatum ball of having a respite, smaller part summer mixture, Rhizoma Zingiberis Recens removing pathogen in the heart sheet, SANJIU WEITAI electuary, aplotaxis carminative pill, KUAIWEI PIAN, stomach function regulating sheet and middle reason spleen ball, peratodynia sheet, stomach clever sheet alive, stomach reinforcing capsule, fragrant sand half stomach electuary, cyperus-amomum stomach electuary, JIANWEI WAN, SHIXIANG pill for relieving pain, Bi bell stomachache electuary, compound sheet, stomach nourishing granule etc.But populous because of China, this sick sickness rate is higher, and comparatively speaking, existing kind is not enough.More owing to the TCM Syndrome Type complexity of chronic superficial gastritis, clinical single card is less, and compound card is many especially.And in the existing kind, rarer in order to cure mainly compound card person, the kind of its disease syndrome of stagnation of liver qi and spleen deficiency that specially effects a permanent cure is more rare.So the tcm product of exploitation treatment chronic gastritis has wide practical value and market prospect.
Summary of the invention
The object of the present invention is to provide a kind of pharmaceutical preparation for the treatment of gastritis.
Another object of the present invention provides the preparation method and its usage of this medicine.
Technical scheme of the present invention: the invention provides a kind of medicine for the treatment of gastritis, it is by containing the medicament that following raw materials by weight proportions is made at least:
3.2~4.8 parts of 3.2~4.8 portions of Rhizoma Cyperis of Pericarpium Citri Reticulatae Viride.
Wherein crude drug also contains:
1.6~2.4 parts of 4~6 parts of Fructus Evodiaes of 1.6~2.4 portions of Aspongopuss of 4~6 parts of Cortex Magnoliae Officinalis of the Radix Aucklandiae.
Further, crude drug also contains:
2.4~3.6 parts of 4~6 portions of Rhizoma Coptidis of 4~6 parts of Rhizoma Corydalis of 2.4~3.6 parts of Herba Paederiaes of 8~12 parts of Rhizoma Atractylodis of Radix Pseudostellariae.
Preferably, it is the medicament of being made by following raw materials by weight proportions:
1.6~2.4 parts of 3.2~4.8 parts of Fructus Evodiaes of 3.2~4.8 portions of Rhizoma Cyperis of Pericarpium Citri Reticulatae Viride
4~6 parts of 1.6~2.4 parts of Herba Paederiaes of 4~6 parts of Cortex Magnoliae Officinalis of the Radix Aucklandiae
4~6 parts of 4~6 parts of Radix Pseudostellariae 8~1 2 part Rhizoma Corydalis of Aspongopus
2.4~3.6 parts of 2.4~3.6 portions of Rhizoma Coptidis of Rhizoma Atractylodis.
Preferred, it is the medicament of being made by following raw materials by weight proportions:
5 parts of 2 parts of Radix Aucklandiae of 4 parts of Fructus Evodiaes of 4 portions of Rhizoma Cyperis of Pericarpium Citri Reticulatae Viride
10 parts of 5 parts of Radix Pseudostellariaes of 5 portions of Aspongopuss of 2 parts of Herba Paederiaes of Cortex Magnoliae Officinalis
3 parts of 3 portions of Rhizoma Coptidis of 5 parts of Rhizoma Atractylodis of Rhizoma Corydalis.
Said medicament is a said dosage form on any pharmaceutics, and specifically, said medicament is any peroral dosage form commonly used, as pill, powder, tablet, capsule, and oral agents, more particularly this medicament is a sugar free granule.
The present invention also provides the application of each raw material in the medicine of the acute and chronic gastritis of preparation treatment of weight proportion.
The present invention also provides its preparation technology:
A, get Pericarpium Citri Reticulatae Viride earlier,, sieve 50%~65% pulverizing wherein, standby;
B, residue Pericarpium Citri Reticulatae Viride and Fructus Evodiae, the Radix Aucklandiae, Rhizoma Cyperi, Rhizoma Atractylodis, Cortex Magnoliae Officinalis are extracted volatile oil with steam distillation, keep volatile oil, and be standby;
C, medicinal residues and Rhizoma Coptidis, Herba Paederiae, Aspongopus, Radix Pseudostellariae, Rhizoma Corydalis that the b step is carried behind the oil are fried in shallow oil altogether, fry in shallow oil altogether 2 times, add the water of 7 times of amounts for the first time, add the water of 6 times of amounts for the second time, decoct 1 hour at every turn, and medicinal liquid filters, and concentrates, and drying is collected the dry extract powder;
D, the Green Tangerine Peel with adding a step in the dry extract of c step, the volatile oil of b step and the adjuvant of pharmaceutically using always are made pharmaceutical preparation.
Medicament selection Pericarpium Citri Reticulatae Viride of the present invention, Rhizoma Cyperi combination, wherein selecting Pericarpium Citri Reticulatae Viride for use is because of Pericarpium Citri Reticulatae Viride bitter in the mouth suffering, slightly warm in nature, main liver, spleen, the stomach warp of returning, be longer than dispersing the stagnated live-QI to relieve the stagnation of QI, circulation of qi promoting removes expands digesting and appetizing, this side selects this product for use, at the pathogenesis of stagnation of liver-QI and stomach-QI, can effectively alleviate the gastral cavilty distending pain, two sides of body are attacked and are scurried, lack of appetite uncomfortable in chest, symptoms such as belch acid regurgitation; Rhizoma Cyperi, acrid in the mouth and little hardship is sweet, property is flat, mainly returns Liver Channel and current three warmers, the function dispersing the stagnated live-QI to relieve the stagnation of QI, regulating QI to relieve pain, this product is comprehensively at liver constraint and blockage, QI stagnating in middle-JIAO, gastralgia, distension, the etiology and pathogenesis of all diseases of belch; Cold not hot, hot fragrant and not dry strong, promote qi circulation opening is stagnant and not high violent, so two medicines are made monarch drug altogether.
Except Pericarpium Citri Reticulatae Viride, outside the Rhizoma Cyperi, the present invention also selects the Radix Aucklandiae, Cortex Magnoliae Officinalis, and Aspongopus, Fructus Evodiae is because of the Radix Aucklandiae, property and flavor of peppery and warm, the master goes into spleen, Liver Channel, is promoting the circulation of QI to relieve pain product commonly used; Fructus Evodiae acrid in the mouth bitterness temperature is apt to into liver, stomach two warps, its regulating QI to relieve pain, and the power of warming middle-JIAO dampness is strong; Cortex Magnoliae Officinalis is arduous warm in nature, and the master goes into the taste warp, is main effect with circulation of qi promoting except that expanding turbid with dampnessization.Aspongopus, hot sweet slightly warm in nature, the function regulating QI to relieve pain, warming middle-JIAO is supporing yang; More than four medicines, approximate with Pericarpium Citri Reticulatae Viride, Rhizoma Cyperi performance function, the same usefulness of compatibility, the mutual-assistance is intended to increase the soothing the liver circulation of qi promoting of monarch drug, the effect of relieving pain by regulating middle-JIAO for helping.Both can eliminate the cause of disease, can alleviate the symptom of the stagnation of QI again, so be all ministerial drug.
In order to reach better therapeutic, the present invention also makes up with Radix Pseudostellariae, Rhizoma Atractylodis, Herba Paederiae, Rhizoma Corydalis.This is because Radix Pseudostellariae, and nature and flavor are sweet flat, can strengthening the spleen gas, and nourishing stomach-YIN; Rhizoma Atractylodis are arduous and warm, the spleen strengthening and damp drying; The Herba Paederiae nature and flavor are worked hard and are put down, and are longer than the pain relieving dyspepsia and intestinal stasis relieving; Radix Pseudostellariae, Rhizoma Atractylodis, Herba Paederiae three medicines, double see insufficiency of the spleen of the disease of effecting a permanent cure altogether is in order to set upright.Because of gastral cavilty pain, just sick pain is gone into network for a long time at gas again, Rhizoma Corydalis blood-activating and qi-promoting and pain relieving in order to promoting blood circulation to remove obstruction in the collateral, eliminates the stasis of blood to stagnate in the side, and alleviate gastralgia, the double blood stasis of controlling chronic prolonged illness; Rhizoma Coptidis nature and flavor bitter cold, heat clearing and damp drying, clearing stomach detoxifcation is controlled the wet resistance of the stagnation of QI in order to double.Accumulate and steam and heat-transformation; And restriction Fructus Evodiae isothermal medicine help fire.The above five tastes all in order to the treatment accompanied symptoms, make for assistant altogether.
Medicine of the present invention has soothing liver and strengthening spleen, and the function of relieving pain by regulating middle-JIAO for treatment gastritis provides a kind of new way, because medicine of the present invention can be prepared to the sugar-free granule, is applicable to diabetic to take simultaneously.
The specific embodiment
Below by testing the beneficial effect of further setting forth medicine of the present invention.These tests comprise pharmacodynamics test, and pharmacological toxicology is learned test, the clinical observation on the therapeutic effect test.
Test example 1 medicine of the present invention is to the influence of acute and chronic gastritis animal model
1, experiment material
(1) medicine
1. be subjected to the reagent thing: medicine of the present invention.Clinical consumption 4 grams/time, 3 times/day.4 gram/bags, every gram contain primary crude drug 4 grams.Three dosage groups are established in test: the clinical dosage of drafting of medicine of the present invention is the former medicines of 48 grams every day, by the about 50 kilograms of calculating of the general body weight of adult, human dosage is 0.96 gram former medicine/kilogram, it is 4.8 gram former medicine/kilograms, 9.6 gram former medicine/kilograms, 14.4 gram former medicine/kilograms that large, medium and small test dose is set, and is clinical 5 times, 10 times, 15 times of drafting dosage.
2. positive drug: SANJIU WEITAI KELI, three nine-day periods after the winter solstice, pharmaceutical factory produced, lot number: 20001116,2 times/day, 1 bag/time, 20 gram/bags.Attending effectiveness: anti-inflammatory analgetic, regulate the flow of vital energy and be good for the stomach, be used for superficial gastritis, erosive gastritis.Authentication code: ZZ-5012-defends in Guangdong the accurate word (1994) of medicine No. 904001.
3. other medicines: salicylic acid, analytical pure, chemical reagent three factories in Tianjin produce, lot number: 940418 first nitro nitroguanidines (MNNG), FLUKA company product, lot number: 19990402
(2) animal SD rat
2, experimental technique and result
(1) medicine of the present invention causes the influence of rat acute gastritis model to salicylic acid
Get 60 of body weight 140~180 gram healthy SD rats, male and female half and half, be divided into blank group, model group, the heavy dose of group of medicine of the present invention (14.4 gram former medicine/kilogram) at random, dosage group in the medicine of the present invention (9.6 gram former medicine/kilogram), medicine small dose group of the present invention (4.8 gram former medicine/kilogram), six groups of SANJIU WEITAI KELI positive controls (4 gram granule/kilogram), 10 every group.Irritate stomach in continuous six days respectively with 1.0 milliliters/100 gram volumes and respectively organize medicinal liquid (wherein blank group, model group gavage distilled water), fasting 12 hours, in last administration in the 7th day after 1 hour except that blank rat matched group, each organizes rat with 20 mMs/rise salicylic acid (0.5% sodium carboxymethyl cellulose) suspension oral gavage, and dosage 10 milliliters/100 grams were put to death rat after 4 hours, take out full stomach, fix with 10% formalin, cut off after 15 minutes, rat stomach inflammation is respectively organized in observation, and a situation arises.Judge classification with following standard: "-" no gastritis takes place; "+" contrafluxion, mild inflammation; " ++ " is serious congested, and local inflammation is obvious; " +++" the visible diffuse inflammation variation of full stomach.Be designated as 0,1,2,3 respectively.
Model group rat after irritating stomach with 20 mMs/rise salicylic acid 4 hours, its stomach local inflammation is obvious.Have obviously than model group and alleviate and the large, medium and small dosage group of medicine of the present invention causes rat acute stomach local inflammation to salicylic acid.The results are shown in following table.
Table 1 medicine of the present invention causes the influence of rat acute gastritis model to salicylic acid
The scoring of group dosage number of animals gastritis
(restraining former medicine/kilogram) (only)
Blank group-10 0
Salicylic acid model group-10 18
Heavy dose+salicylic acid group 14.4 10 4
Middle dosage+salicylic acid group 9.6 10 9
Low dose+salicylic acid group 4.8 10 9
SANJIU WEITAI+salicylic acid group 4 gram granule/kilograms 10 6
Annotate: " gastritis scoring " is the summation that the inflammation standard of 10 animals is judged the classification marking value.
(2) medicine of the present invention is to the influence of rat chronic gastritis model
Get 60 of body weight 140~180 gram healthy SD rats, male and female half and half, be divided into dosage group (9.6 gram former medicine/kilogram) in blank group, model group, the heavy dose of group of medicine of the present invention (14.4 gram former medicine/kilogram), the medicine of the present invention, medicine small dose group of the present invention (4.8 gram former medicine/kilogram), six groups of SANJIU WEITAI KELI positive controls (4 gram granule/kilogram) at random, 10 every group.Got first nitro nitroguanidine 2 gram in per three days, be made into the preservation liquid of 1 grams per liter, lucifuge, 4 ℃ of cold preservations with 200 milliliters of distilled water.Be mixed with concentration with preservation liquid every day is that the diluent of 100 mg/litre is put in the brown bottle, allows model group and medicine group freely drink, and irritates 2 milliliters/time in stomach with 40% ethanol simultaneously, the blank group gives distilled water and drinks, irritate 2 milliliters/time in stomach, secondary, totally 10 weeks weekly with distilled water.The 11st week beginning, medicine group begin to irritate stomaches by following dosage with 1 milliliter/100 gram volumes every day, and model group and blank group give isopyknic distilled water, continuous 6 weeks.The 17th week, rat is put to death, get stomach, the place cuts off in greater gastric curvature.10% formalin is fixed, and makes the pathology sections observation.The model group rat is after 16 all MNNG and 40% ethanol gavage, and visible antrum layer of check pathological section and a large amount of kitchen range lymphocytic infiltrations of tela submucosa and lymphocyte are assembled, the body of stomach cell infiltration, and serious mucomembranous surface is slightly rotten to the corn, cell detachment.After 6 weeks, its inflammatory conditions has clear improvement with Drug therapy of the present invention, and antrum is dispersed in cell infiltration on a small quantity, and body of stomach is dispersed in a little cell infiltration.Its result sees table 2 for details.
Table 2 medicine of the present invention is to the influence of rat chronic gastritis model
Each organizes rat check pathological section situation statistics (only)
The gastric antrum body of stomach
(the gram inflammatory cell soaks dosage
Number of animals
Former medicine/public affairs
(only) a large amount of kitchen range pouring profits are serious
Jin)
Group
It is thin that the crust cellular infiltration is dispersed in scorching a little inflammation on a small quantity
Normal normal mucosa surface
And lymphocyte cellular infiltration born of the same parents are soaked into
It is slight rotten to the corn,
Assemble
Cell detachment
Blank group 10-10--10--
The chronic gastritis model
10 - - 8 2 - 9 1
Group
Medicine of the present invention is big
10 14.4 1 - 9 3 - 7
The dosage group
In the medicine of the present invention
10 9.6 1 1 8 1 2 7
The dosage group
Medicine of the present invention is little
10 4.8 1 9 1 2 7
The dosage group
SANJIU WEITAI KELI
4 gram granules
10
1 1 8 1 1 8
Matched group
/ kilogram
Result of the test shows: medicine of the present invention can obviously alleviate the acute stomach local inflammation that salicylic acid causes rat, and can reduce first nitro nitroguanidine (MNNG) and 40% ethanol and cause the stomach pathologic of chronic gastritis rat model to change.Show that medicine of the present invention has certain therapeutical effect to acute and chronic gastritis animal model.
The anti-inflammatory analgetic experiment of test example 2 medicines of the present invention
1, experiment material
(1) medicine
1. be subjected to the reagent thing: medicine of the present invention 4 grams/time, 3 times/day.4 gram/bags, every gram contain primary crude drug 4 grams.Three dosage groups are established in test: the clinical dosage of drafting of medicine of the present invention is the former medicines of 48 grams every day, by the about 50 kilograms of calculating of the general body weight of adult, human dosage is 0.96 gram former medicine/kilogram, it is 4.8 gram former medicine/kilograms, 9.6 gram former medicine/kilograms, 14.4 gram former medicine/kilograms that large, medium and small test dose is set, and is clinical 5 times, 10 times, 15 times of drafting dosage.
2. positive drug: etidocine tablet (indometacin enteric-coated tablet), Jintan City, Jiangsu Province pharmaceutical manufacturing, No. the 311806th, the accurate word (1985) of Su Wei medicine, lot number 200003313, anti-inflammatory analgesic is used for rheumatoid arthritis.Oral one time 1,2~3 times on the one, increase to one in case of necessity 4~6, divide and take for 3~4 times.25 milligrams/sheet.
Codeine phosphate tablets is produced along pharmaceutical factory in Beijing, and the accurate word (1996) of medicine is defended No. 115002 in the capital.Lot number: 20000205, analgesic, cough medicine.Oral one time 15 milligrams-30 milligrams, one day 30 milligrams-90 milligrams.
(2) animal SD rat, the KM mice
2, experimental technique and result
(1) influence of medicine xylol induced mice auricle edema of the present invention
Get 50 of the healthy Kunming mouses of body weight 18~22 grams, male and female half and half, be divided into dosage group (9.6 gram former medicine/kilogram), medicine small dose group of the present invention (4.8 gram former medicine/kilogram), five groups of indometacin positive controls (80 milligrams/kilogram) in blank group, the heavy dose of group of medicine of the present invention (14.4 gram former medicine/kilogram), the medicine of the present invention at random, 10 every group.Irritate stomach respectively in continuous seven days with 0.3 milliliter/10 grams and respectively organize medicinal liquid, the blank group gives with the volume distilled water, after the last administration 30 minutes, dimethylbenzene dripped in mouse right ear cause inflammation, put to death mice after 15 minutes, punch in mice left and right sides ears same area with card punch, and the both sides auricle of weighing respectively, the two auricle weight differences (being the swelling degree) of surveying calculated.Inhibitory rate of intumesce=(the average swelling rate of the matched group-average swelling rate of administration group)/average swelling rate of matched group.
Behind continuous seven days gastric infusions of the heavy dose of group of medicine of the present invention mice, the mice caused by dimethylbenzene xylene ear thickness obviously reduces, and compares with the blank group, and the swelling degree obviously reduces, and significant difference is arranged.Detailed results sees Table 3.
The influence of table 3 medicine xylol of the present invention auricle edema
Group dosage number of animals swelling degree inhibitory rate of intumesce
(restraining former medicine/kilogram) (only) (mg (%) of X ± SD)
Blank group-10 8.6 ± 3.3-
Heavy dose of group 14.4 10 5.3 ± 1.8
*24.48
Middle dosage group 9.6 10 6.9 ± 2.9 10.50
Small dose group 4.8 10 8.4 ± 3.0 2.87
7.5 milligrams/kilogram 10 2.0 ± 0.9 of indometacin
* *63.21
Annotate: compare with the distilled water group, "
*" p<0.05, "
*" p<0.01, "
* *" p<0.001;
(2) medicine of the present invention is to the bullate influence of rat granuloma
Get 50 of body weight 120~160 gram healthy SD rats, male and female half and half, be divided into dosage group (9.6 gram former medicine/kilogram), medicine small dose group of the present invention (4.8 gram former medicine/kilogram), five groups of indometacin positive controls (80 milligrams/kilogram) in blank group, the heavy dose of group of medicine of the present invention (14.4 gram former medicine/kilogram), the medicine of the present invention at random, 10 every group.During test, 3.0 milligrams/100 gram anesthesia of lumbar injection pentobarbital sodium.Strange portion iodophor disinfection about every Mus, and cut an osculum, subcutaneous with about 20 milligrams of sterilization cotton balls of pincet weighing from the osculum implantation, sew up immediately.From performing the operation the same day, each group was irritated stomach respectively in continuous seven days with 1.0 milliliters/100 grams and is respectively organized medicinal liquid, and the blank group gives with the volume distilled water, after the last administration 1 hour, open former otch, cotton balls is taken out together with connective tissue on every side, reject fat, put to dry in the baking oven and weigh.With claim weight deduct the former weight of cotton balls and promptly get granulomatous nt wt net weight, calculate the granulomatous weight of per 100 gram body weight rats, and carry out statistics t check.
The heavy dose of group of medicine of the present invention rat gavaged Drug therapy of the present invention in continuous seven days after implanting the sterilization cotton balls, granulomatous weight obviously reduces on its cotton balls, compares with the blank group, and significant difference is arranged.Detailed results sees the following form 4.
Table 4 medicine of the present invention is to the bullate influence of rat granuloma (X ± SD)
Group dosage number of animals granuloma is heavy
(restraining former medicine g/kg) (only) mg/100g body weight
Blank group-10 212.2 ± 35.2
Heavy dose of group 14.4 10 179.2 ± 24.2
*
Middle dosage group 9.6 10 193.6 ± 20.6
Small dose group 4.8 10 209.3 ± 34.9
7.5 milligrams/kilogram 10 94.1 ± 14.5 of indometacin
* *
Annotate: compare with the distilled water group, "
*" p<0.05, "
*" p<0.01, "
* *" p<0.001.
Result of the test shows: medicine of the present invention can obviously reduce the mice caused by dimethylbenzene xylene ear thickness, obviously reduces and implants the granuloma weight on the cotton balls in the rat body, and tangible antiinflammatory action is arranged.
(3) medicine of the present invention is to the influence of mice hot plate test
Get 50 of the healthy Kunming kind female mices that body weight 18~22 gram meets the hot plate test requirement, be divided into 5 groups at random, 10 every group.Each administration group dosage is respectively dosage group (9.6 gram former medicine/kilogram) in the heavy dose of group of medicine of the present invention (14.4 gram former medicine/kilogram), the medicine of the present invention, medicine small dose group of the present invention (4.8 gram former medicine/kilogram), codeine phosphate matched group (9 milligrams/kilogram), gastric infusion.Blank group filling stomach gives the distilled water with volume.Successive administration 7 days, after the last administration 0,45,90,120 minute, hot plate was measured its pain threshold.
Successive administration 7 days after the last administration 90 minutes, the hot plate of dosage group mice was measured pain threshold and is obviously improved in the heavy dose of group of medicine of the present invention mice, the medicine of the present invention.With compare before the last administration, significant difference is arranged.The hot plate of the heavy dose of group of medicine of the present invention mice was measured pain threshold and is then more obviously improved by 120 minutes, and compared before the last administration, and utmost point significant difference is arranged.Detailed results sees the following form 5.
Table 5 medicine of the present invention is to the analgesic activity of mice
Percentage rate is improved in the pain threshold threshold of pain after the preceding threshold of pain administration of group animals administer
Number meansigma methods (s) (%)
(only) be 45min 90min 120min 45min 90min 120min (s)
Blank group 10 20.03 ± 4.20 20.49 ± 4.09 20.81 ± 3.79 20.86 ± 3.91 2.30 3.89 4.14
Heavy dose of group 10 20.10 ± 3.41 23.41 ± 3.91 25.71 ± 4.83
* △26.45 ± 5.86
* △ △16.47 27.91 31.59
Middle dosage group 10 20.03 ± 3.84 22.25 ± 3.56 24.68 ± 4.14
* △22.92 ± 4.46 11.08 23.22 14.43
Small dose group 10 19.59 ± 3.21 19.87 ± 3.36 20.08 ± 3.39 20.15 ± 3.45 1.43 2.50 2.86
Codeine group 10 19.83 ± 3.04 56.41 ± 7.40
* * △ △ △39.01 ± 5.73
* * △ △ △33.78 ± 4.20
* * △ △ △184.47 96.72 70.35
Annotate: compare with the blank group "
*" p<0.05, "
*" p<0.01, "
* *" before p<0.001 and self medicine relatively "
*" p<0.05, "
△ △" p<0.01, "
△ △ △" p<0.001.
(4) medicine of the present invention is to the influence of mice acetic acid twisting method test
Get 50 of the healthy Kunming mouses of body weight 18~22 grams, male and female half and half are divided into 5 groups at random, 10 every group.Each administration group dosage is respectively dosage group (9.6 gram former medicine/kilogram) in the heavy dose of group of medicine of the present invention (14.4 gram former medicine/kilogram), the medicine of the present invention, medicine small dose group of the present invention (4.8 gram former medicine/kilogram), codeine positive controls (9 milligrams/kilogram), gastric infusion.Blank group filling stomach gives the distilled water with volume.Successive administration 7 days, after the last administration 60 minutes, each organized respectively that lumbar injection 0.9% glacial acetic acid 0.1 milliliter/10 grams bring out writhing response, calculates every Mus writhing response number of times in 15 minutes.
After 7 days, the heavy dose of group of medicine of the present invention mice is brought out the writhing response number of times to 0.9% glacial acetic acid and obviously reduces at continuous irrigation stomach medicine of the present invention, and the writhing response suppression ratio reaches 23.46%, compares with the blank group, and significant difference is arranged.Detailed results sees the following form 6.
Table 6 medicine Dichlorodiphenyl Acetate of the present invention causes the influence of mouse writhing reaction
Group number of animals dosage is turned round body suppression ratio P value
(only) (restraining former medicine/kilogram) (inferior) (%)
Blank group 10-32.4 ± 8.55--
Heavy dose of group 10 14.4 24.8 ± 6.92 23.46<0.05
Middle dosage group 10 9.6 28.3 ± 7.67 12.65>0.05
Small dose group 10 4.8 32.8 ± 7.50-1.23>0.05
10 9 milligrams/kilogram 0.0 ± 0.00 100<0.001 of codeine groups
Annotate: the P value is to compare with model group.
Result of the test shows: medicine analgesic activity of the present invention is obvious, can obviously improve the hot plate pain threshold of mice, and can reduce the writhing response number of times that acetic acid brings out mice.
Test example 3 medicines of the present invention are to the influence of animals with spleen deficiency gastrointestinal function
1, experiment material
(1) medicine
Be subjected to the reagent thing: medicine of the present invention 4 grams/time, 3 times/day.4 gram/bags, every gram contain primary crude drug 4 grams.Three dosage groups are established in test: the clinical dosage of drafting of medicine of the present invention is the former medicines of 48 grams every day, by the about 50 kilograms of calculating of the general body weight of adult, human dosage is 0.96 gram former medicine/kilogram, it is 4.8 gram former medicine/kilograms, 9.6 gram former medicine/kilograms, 14.4 gram former medicine/kilograms that large, medium and small test dose is set, and is clinical 5 times, 10 times, 15 times of drafting dosage.
Positive drug: BUZHONG YIQI WAN, Nanchong, Sichuan pharmaceutical factory produces, lot number: 010305001, authentication code: ZZ-0208-defends in the river the accurate word (1998) of medicine No. 013626, function with cure mainly: invigorating the spleen and replenishing QI, ascending up spleen-Qi and Yang.Be used for weakness of the spleen and stomach, sinking of QI of middle-JIAO, fatigue and asthenia, lack of appetite abdominal distention, chronic diarrhea, proctoptosis, uterine prolapse.Usage and consumption: oral, one time 6 gram, 2~3 times on the one.
(2) animal KM mice, the SD rat
2, experimental technique
Make spleen deficiency animal model (biology department of the moulding Beijing Normal University digestive physiology scientific research group of traditional Chinese medical science syndrome of spleen-deficiency animal model, Chinese Medical Journal, 1980,60 (2): 83) according to the bibliographical information mode
(1) medicine of the present invention is to the influence of mice with spleen deficiency intestinal motility due to the Radix Et Rhizoma Rhei
Get 60 of the healthy Kunming mouses of body weight 18~22 grams, male and female half and half, be divided into dosage group (9.6 gram former medicine/kilogram), medicine small dose group of the present invention (4.8 gram former medicine/kilogram), six groups of BUZHONG YIQI WAN positive controls in blank group, model group, the heavy dose of group of medicine of the present invention (14.4 gram former medicine/kilogram), the medicine of the present invention at random, 10 every group.Except that the blank group, each group gavaged 200% Radix Et Rhizoma Rhei decocting liquid in continuous seven days with 0.3 milliliter/10 grams, gavaged the distilled water except that blank group and model group in the 8th day, all the other four groups gavage each dosage medicinal liquid respectively simultaneously, continuous seven days, fasting 12 hours, in last administration next day (containing 50% carbon element prepared Chinese ink) back 30 minutes, taking off neck puts to death, open the abdominal cavity and separate mesentery, the clip upper end is to pylorus, and the lower end is to the intestinal tube of ileocecum portion, gently draw small intestinal to be in line, survey intestinal tube length overall and prepared Chinese ink propulsive distance in intestinal tube.Calculate the propulsive percentage rate of prepared Chinese ink with formula, and note observing and respectively organize the small intestinal volume and whether increase.
After gavaging Radix Et Rhizoma Rhei in continuous 14 days for mice with Radix Et Rhizoma Rhei to cause model of spleen deficiency, the prepared Chinese ink of model group mice advances percentage rate and flatulence ratio obviously to increase, and intestinal tympanites length obviously extends, and compares with the blank group, and utmost point significant difference is arranged.And after 7 days, beginning to use Drug therapy of the present invention up to 14 days in modeling, the prepared Chinese ink of the mice of the heavy dose of group of medicine of the present invention advances percentage rate, flatulence and intestinal tympanites length ratio obviously to reduce, and compares with model group, and utmost point significant difference is arranged.Detailed results sees the following form 7.
Table 7 medicine of the present invention is to the influence of mice with spleen deficiency intestinal motility due to the Radix Et Rhizoma Rhei
Group dosage number of animals prepared Chinese ink propelling rate intestinal tympanites length flatulence
Restrain (%) (cm) ratio of former medicine/kg (only)
(%)
Blank group-10 55.2 ± 6.6 13 2.08
Radix Et Rhizoma Rhei model group 60 10 77.2 ± 14.5
△ △ △49 8.10
Heavy dose+Radix Et Rhizoma Rhei group 14.4 10 58.9 ± 10.2
*15.0 2.69
Middle dosage+Radix Et Rhizoma Rhei group 9.6 10 71.7 ± 19.7
△21.0 3.59
Low dose+Radix Et Rhizoma Rhei group 4.8 10 73.3 ± 15.8
△ △47.0 8.47
BUZHONG YIQI WAN+Radix Et Rhizoma Rhei group 1.8 gram/kilograms 10 60.6 ± 11.7
*00
Annotate: compare with the Radix Et Rhizoma Rhei model group, "
*" p<0.05, "
*" p<0.01, compare with the blank group, "
△" p<0.05, "
△ △" p<0.01.
(2) medicine of the present invention causes the influence of the gastric emptying of Mice with Spleen model to reserpine
Get 60 of the healthy Kunming mouses of body weight 18~22 grams, male and female half and half, be divided into dosage group (9.6 gram former medicine/kilogram), medicine small dose group of the present invention (4.8 gram former medicine/kilogram) in blank group, model group, the heavy dose of group of medicine of the present invention (14.4 gram former medicine/kilogram), the medicine of the present invention at random, six groups of BUZHONG YIQI WAN positive controls, 10 every group.Except that the blank group, 0.3 milligram/kilogram of every mice subcutaneous injection of reserpine every day, each administration group is according to dosage irritated stomach and is given medicine simultaneously, and blank group, model group give the distilled water with volume.Continuous 14 days, fasting was 24 hours after the last administration, gave 0.1% methyl orange aqueous solution of every mouse stomach 0.2ml.Put to death after 20 minutes, win stomach, place beaker, add 10 ml distilled waters, regulate PH to 6~6.5 with NaHCO3, separation of supernatant is surveyed methyl orange residual rate in each mice stomach with colorimetry.
The model group mice is behind 0.3 milligram/kilogram of continuous 14 days subcutaneous injection of reserpine, and the methyl orange residual rate obviously reduces in the stomach, compares with the blank group, and significant difference is arranged.Dosage group mice gavaged medicine of the present invention at continuous 14 days in the subcutaneous injection of reserpine in medicine of the present invention heavy dose of group mice and the medicine of the present invention, and the methyl orange residual rate obviously increases in the mice stomach as a result, compares with model group, and significant difference is arranged.
Table 8 medicine of the present invention causes the influence (X ± SD) of the gastric emptying of Mice with Spleen model to reserpine
Group number of animals dosage (restraining former medicine/kilogram) methyl orange residual rate (%)
Blank group 10-33.93 ± 5.27
Model group 10-27.81 ± 5.82
△
Heavy dose of group 10 14.4 34.58 ± 5.63
*
Middle dosage group 10 9.6 35.03 ± 6.12
*
Small dose group 10 4.8 26.25 ± 6.64
△
Invigorating the spleen and replenishing QI group 10 1.8 gram/kilograms 33.394 ± 6.78
*
Annotate: compare with model group, "
*" p<0.05, "
*" p<0.01, compare with the blank group, "
△" p<0.05, "
△ △" p<0.01.
Result of the test shows: medicine of the present invention has tangible spleen reinforcing and improves the effect of the gastrointestinal function of animals with spleen deficiency model, can make that the methyl orange residual rate obviously increases in the mice with spleen deficiency stomach, the prepared Chinese ink that obviously reduces mice advances percentage rate, flatulence and intestinal tympanites length ratio.
(3) medicine of the present invention causes the influence of the spleen and stomach function of rat model of spleen deficiency to Radix Et Rhizoma Rhei
Get 60 of body weight 180~220 gram healthy SD rats, male and female half and half, be divided into dosage group (9.6 gram former medicine/kilogram), medicine small dose group of the present invention (4.8 gram former medicine/kilogram), six groups of BUZHONG YIQI WAN positive controls in distilled water blank group, model group, the heavy dose of group of medicine of the present invention (14.4 gram former medicine/kilogram), the medicine of the present invention at random, 10 every group.Each group is with 1.0 milliliters/100 grams, gavaged 200% Radix Et Rhizoma Rhei decocting liquid (except the blank group) of 2.0 gram former medicine/milliliters in continuous 14 days, according to dosage simultaneously in continuous 10 days of gastric infusion in afternoon, blank group, model group give the distilled water with volume to each administration group afterwards.After the last administration 1 hour, irritate respectively that 1 milliliter of stomach 20%D-xylose aqueous solution/only, 5 hours urines are collected in fasting, survey respectively organize rat urinate in D-xylose content, put to death the weight that rat claims its spleen, stomach, thymus simultaneously, and calculate its organ index.Get rat intestine and place water, amount is respectively organized the floating length of rat intestine in water, and calculates floating long all data of rate (the floating length/intestinal segment total length of water midgut) and all do statistical procedures.
The model group rat is after gavaging 200% Radix Et Rhizoma Rhei decocting liquid in continuous 24 days, and D-xylose content has very obviously decline in the rat urine, shows that rat reduces the metabolic capacity of D-xylose.Simultaneously, the floating long rate of rat intestine obviously increases.Compare with the blank group, utmost point significant difference is arranged.And the heavy dose of group of medicine of the present invention rat is used Drug therapy of the present invention 10 days simultaneously after gavaging 200% Radix Et Rhizoma Rhei decocting liquid in continuous 14 days.D-xylose content begins obvious rising in the rat urine as a result, compares with model control group, and significant difference is arranged.The floating long rate of rat intestine obviously reduces.Compare with model control group, utmost point significant difference is arranged.Can obviously influence organ coefficients such as the spleen of rat, thymus and gavage 200% Radix Et Rhizoma Rhei decocting liquid.Compare with the blank group, organ coefficients such as the spleen of rat, thymus significantly reduce.Obviously increase through organ coefficients such as the spleen of Drug therapy rat of the present invention, thymus.Compare with model control group, significant difference is arranged.Detailed results sees the following form 9,10.
Table 9 medicine of the present invention to Radix Et Rhizoma Rhei cause Rats with Spleen-deficiency D-xylose content and intestinal tympanites influence
(X±SD)
The floating long rate of group animal dosage D-xylose content intestinal
Number (restraining former medicine/kilogram) (restraining/5 hours urine) (%)
Blank group 10-0.18 ± 0.05 36.9 ± 16.1
Model group 10-0.11 ± 0.04
△ △60.6 ± 22.0
△ △
Model+heavy dose group 10 14.4 0.16 ± 0.06
*45.2 ± 17.0
*
Model+middle dosage group 10 9.6 0.10 ± 0.05 38.9 ± 19.1
Model+small dose group 10 4.8 0.12 ± 0.05 31.6 ± 11.2
Model+invigorating middle warmer group 10 1.8 gram/kilograms 0.15 ± 0.04
*48.0 ± 21.6
*
Annotate: compare with model group, "
*" p<0.05, "
*" p<0.01, compare with the blank group, "
△" p<0.05, "
△ △" p<0.01.
Table 10 medicine of the present invention causes the influence (X ± SD) of the taste stolen goods device coefficient of rat model of spleen deficiency to Radix Et Rhizoma Rhei
| Group animal dosage (primary spleen index thymus index adrenal gland index stomach index is counted medicine gram/kilogram) (only) |
| Blank group 10-0.2801 ± 0.0333 0.1405 ± 0.0340 0.0191 ± 0.0056 0.7267 ± 0.0422 model group 10-0.2446 ± 0.0405 △ 0.1031±0.0338 △0.0160 ± 0.0056 0.6907 ± 0.0541 model+heavy dose group 10 14.4 0.2744 ± 0.0295 *0.1300 ± 0.0268 0.0189 ± 0.0065 0.7233 ± 0.0332 model+middle dosage group 10 9.6 0.3051 ± 0.0589 * 0.1471±0.0358 *0.0210 ± 0.0063 0.7583 ± 0.0871 model+small dose group 10 4.8 0.2591 ± 0.0533 0.1168 ± 0.0129 0.0166 ± 0.0028 0.7188 ± 0.0571 model+invigorating middle warmer group 10 1.8 gram/kilograms 0.3003 ± 0.0705 * 0.1455±0.0490 * 0.0199±0.0034 0.7751±0.0913 * |
Annotate: compare with model group, "
*" p<0.05, compare " △ " p<0.05 with the blank group.
Result of the test shows: medicine of the present invention can also obviously improve the D-xylose content in the Rats with Spleen-deficiency urine, and the organ coefficients such as spleen, thymus of Rats with Spleen-deficiency are obviously increased.
By above pharmacodynamics test, draw to draw a conclusion: medicine of the present invention has antiinflammatory, analgesia and spleen reinforcing and improves the effect of gastrointestinal function, and acute and chronic gastritis animal model is had certain therapeutical effect.
4 acute toxicity tests of test example
After giving mouse stomach with mice maximum tolerated dose 76 gram former medicine/kilograms, mice is movable normal, and chroma of hair is ingested and drained normally, does not have dead mouse in seven days, cuts open after seven days and kills mice, perusal mice internal organs, no abnormality seen phenomenon.The LD that shows the mice oral administration
50Greater than 76 gram former medicine/kilograms, illustrate that this medicine has certain safety.
Test example 5 long term toxicity tests
With stomach recovering particles 52 gram former medicine/kilograms, 28.8 gram former medicine/kilograms, 19.2 gram former medicine/three dosage of kilogram (54 times, 30 times, 20 times of suitable clinical dosage respectively), continuous 13 weeks irritate stomach and give rat respectively.Its rat behavior, outward appearance, body weight gain, hemogram, blood biochemical are all no abnormal, and the pathological anatomy and the pathological tissue chemical examination of the rat heart, liver, spleen, lung, kidney, brain, thyroid, thymus, adrenal gland, uterus, ovary or 13 kinds of internal organs such as testis, prostate there is no drug toxicity reaction.Show that this medicine under determined clinical using dosage, takes safety for a long time.
The test of test example 6 clinical observation on the therapeutic effect
The 106 routine patients (age is in the majority with 40~49 years old) that data is comparatively complete in the Drug therapy chronic superficial gastritis syndrome of stagnation of liver qi and spleen deficiency of the present invention add up, chronic superficial gastritis 42 examples, chronic atrophic gastritis 36 examples, chronic superficial atrophic gastritis 28 examples, 64 examples are given birth to intestinalization, 9 examples are with dysplasia, concurrent gastric and duodenal ulcers, cholecystitis, gastroptosis, chronic hepatitis person's 39 examples.All cases all have the gastral cavilty distending pain, lack of appetite, belch or pantothenic acid, weak disease such as grade; And make a definite diagnosis, and get rid of diseases such as organic disease such as liver, gallbladder, pancreas and diabetes through fibergastroscope.Efficacy determination disappears with tcm symptoms such as gastric abscesss, and the normal person of gastroscopy is a clinical recovery; Symptom obviously alleviates, and the gastroscopy inflammation alleviates to taking a turn for the better; Symptom does not have obvious alleviation, and gastroscopy does not have the improver for invalid.Result: clinical recovery 69 examples, 32 examples that take a turn for the better, invalid 5 examples; After 3 course of therapy, 69 examples are with the intestinal survivor, and 7 examples disappear, and 15 examples take a turn for the better, 9 example companion dysplasia persons, and 3 examples disappear.Illustrate that this is effective to chronic gastritis with bright medicine.
Mode below by embodiment further specifies the present invention, but does not therefore limit the present invention among the described scope of embodiments.
Embodiment 1
Pericarpium Citri Reticulatae Viride 336g Rhizoma Cyperi 336g Fructus Evodiae 168g Radix Aucklandiae 420g Cortex Magnoliae Officinalis 168g Herba Paederiae 420g Aspongopus 420g Radix Pseudostellariae 840g Rhizoma Corydalis 420g Rhizoma Atractylodis 252g Rhizoma Coptidis 252g
Preparation method is:
More than ten simply, get Pericarpium Citri Reticulatae Viride 200g and be ground into fine powder earlier, be ground into micropowder again, cross 400 mesh sieves, standby; Residue Pericarpium Citri Reticulatae Viride, Fructus Evodiae, the Radix Aucklandiae, Rhizoma Cyperi, Rhizoma Atractylodis, Cortex Magnoliae Officinalis add 10 times of water gagings and extract the about 4.5ml of volatile oil with steam distillation, usefulness 28g β 3-cyclodextrin ultrasonic enclose 20 minutes under 45 ℃ condition, and sucking filtration, 40 ℃ of dryings 4 hours, standby; Medicinal liquid filters, and filtrate device is in addition preserved, and is standby; Medicinal residues and Rhizoma Coptidis, Herba Paederiae, Aspongopus, Radix Pseudostellariae, the Rhizoma Corydalis carried behind the oil are fried in shallow oil 2 times altogether, add the water of 7 times of amounts for the first time, add the water of 6 times of amounts for the second time, decoct 1 hour at every turn, and medicinal liquid filters, filtrate for later use; Merge above-mentioned two kinds of filtrates, centrifugal with 4000 rev/mins speed, get the clear paste of supernatant concentration, spray drying under the condition of 170~180 ℃ of inlet temperature, 90~100 ℃ of leaving air temps to relative density 1.08 (60 ℃); Collect the dry extract powder, add dextrin 59g, protein sugar 25g, the clathrate of Pericarpium Citri Reticulatae Viride micropowder and above-mentioned volatile oil is lower than 58% at relative humidity, principal pressure 4.5~5.5Mpa, dry granulation under the condition of lateral pressure 0.25Mpa, granule are crossed 10 mesh sieves, and packing is promptly.
Embodiment 2
Pericarpium Citri Reticulatae Viride 403.2g Rhizoma Cyperi 403.2g Fructus Evodiae 201.6g Radix Aucklandiae 504g Cortex Magnoliae Officinalis 201.6g Herba Paederiae 504g Aspongopus 504g Radix Pseudostellariae 1008g Rhizoma Corydalis 504g Rhizoma Atractylodis 252g Rhizoma Coptidis 302.4g
Preparation method:
More than ten simply, get Pericarpium Citri Reticulatae Viride 262g and be ground into fine powder earlier, be ground into micropowder again, cross 400 mesh sieves, standby; Residue Pericarpium Citri Reticulatae Viride, Fructus Evodiae, the Radix Aucklandiae, Rhizoma Cyperi, Rhizoma Atractylodis, Cortex Magnoliae Officinalis add 10 times of water gagings and extract the about 5.4ml of volatile oil with steam distillation, usefulness 33.6g β 3-cyclodextrin ultrasonic enclose 20 minutes under 45 ℃ condition, and sucking filtration, 40 ℃ of dryings 4 hours, standby; Medicinal liquid filters, and filtrate device is in addition preserved, and is standby; Medicinal residues and Rhizoma Coptidis, Herba Paederiae, Aspongopus, Radix Pseudostellariae, the Rhizoma Corydalis carried behind the oil are fried in shallow oil 2 times altogether, add the water of 7 times of amounts for the first time, add the water of 6 times of amounts for the second time, decoct 1 hour at every turn, and medicinal liquid filters, filtrate for later use; Merge above-mentioned two kinds of filtrates, centrifugal with 4000 rev/mins speed, get the clear paste of supernatant concentration, spray drying under the condition of 170~180 ℃ of inlet temperature, 90~100 ℃ of leaving air temps to relative density 1.08 (60 ℃); Collect the dry extract powder, add dextrin 70.8g, protein sugar 30g, the clathrate of Pericarpium Citri Reticulatae Viride micropowder and above-mentioned volatile oil is lower than 58% at relative humidity, principal pressure 4.5~5.5Mpa, dry granulation under the condition of lateral pressure 0.25Mpa, granule are crossed 10 mesh sieves, and packing is promptly.
Embodiment 3 Pericarpium Citri Reticulatae Viride 268.8g Rhizoma Cyperi 268.8g Fructus Evodiae 134.4g Radix Aucklandiae 336g Cortex Magnoliae Officinalis 134.4g Herba Paederiae 336g Aspongopus 336g Radix Pseudostellariae 672g Rhizoma Corydalis 336g Rhizoma Atractylodis 201.6g Rhizoma Coptidis 201.6g
Preparation method:
More than ten simply, get Pericarpium Citri Reticulatae Viride 134.4g and be ground into fine powder earlier, be ground into micropowder again, cross 400 mesh sieves, standby; Residue Pericarpium Citri Reticulatae Viride, Fructus Evodiae, the Radix Aucklandiae, Rhizoma Cyperi, Rhizoma Atractylodis, Cortex Magnoliae Officinalis add 10 times of water gagings and extract the about 3.6ml of volatile oil with steam distillation, usefulness 22.4g beta-schardinger dextrin-ultrasonic enclose 20 minutes under 45 ℃ condition, and sucking filtration, 40 ℃ of dryings 4 hours, standby; Medicinal liquid filters, and filtrate device is in addition preserved, and is standby; Medicinal residues and Rhizoma Coptidis, Herba Paederiae, Aspongopus, Radix Pseudostellariae, the Rhizoma Corydalis carried behind the oil are fried in shallow oil 2 times altogether, add the water of 7 times of amounts for the first time, add the water of 6 times of amounts for the second time, decoct 1 hour at every turn, and medicinal liquid filters, filtrate for later use; Merge above-mentioned two kinds of filtrates, centrifugal with 4000 rev/mins speed, get the clear paste of supernatant concentration, spray drying under the condition of 170~180 ℃ of inlet temperature, 90~100 ℃ of leaving air temps to relative density 1.08 (60 ℃); Collect the dry extract powder, add dextrin 47.2g, protein sugar 20g, the clathrate of Pericarpium Citri Reticulatae Viride micropowder and above-mentioned volatile oil is lower than 58% at relative humidity, principal pressure 4.5~5.5Mpa, dry granulation under the condition of lateral pressure 0.25Mpa, granule are crossed 10 mesh sieves, and packing is promptly.
The relevant references of pharmacological evaluation:
1. China national drug surveilance office " provisions for new drugs approval "
2. Ministry of Health of the People's Republic of China's study of tcm new drug guide
3. pharmacological experimental methodology such as Xu's uncle cloud
4. the disease model of laboratory animal such as Zhu Yu
5. execute modern medicine experimental zoologies such as new formal plan
6. Qi Chen waits the herbal pharmacology research methodology
7. thank new product of Chinese medicine exploitations and application such as elegant fine jade
Thunder wait tirelessly suffer from a deficiency of the kidney, insufficiency of the spleen moulding animal immune, the Ultrastructural comparative study new Chinese medicine of endocrine organ and clinical pharmacology, 1997,7 (10): 208
9. stomach nourishing granule such as Lin Jiang influences new Chinese medicine and clinical pharmacology, 1999,9 (10): 273 to rat atrophic gastritis mucosa tissue form and gut hormone
10. Academy of Traditional Chinese Medicine, Beijing, Beijing Hospital of Traditional Chinese Medicine is about the clinical observation and the experimentation Chinese Medical Journal of insufficiency of the spleen essence, 1982,62 (1): 22
11. Radix Codonopsis such as marquis family's jade to stress type rat stomach electricity, the influence of stomach motion and gastric emptying is in conjunction with magazine, 1989,9 (1): 31
12. animals with spleen deficiency model due to the Heilongjiang Traditional Chinese Medicine university traditional Chinese medical science taste seminar intemperance of taking food and treatment by Chinese herbs are observed, combination of Chinese and Western medicine magazine, 1983,3 (5): 295
Wait drugs for dispelling internal cold to white mice gastric emptying and the active influence of isolated rabbit small intestinal 13. open bright, 1984,12
14. the experimentation of Weitai capsule for treating stomach disease such as Wang Jie treatment atrophic gastritis, new Chinese medicine and clinical pharmacology, 1999,1 (10): 21
15. stomach Yiganning capsule anti-experimental character gastric ulcer effects such as Wang Jianhua, new Chinese medicine and clinical pharmacology, 1996.7 (2): 19
Claims (6)
1, a kind of medicine for the treatment of gastritis is characterized in that: it is the medicament that is prepared from by the following weight proportion raw material:
3.2~4.8 parts on Pericarpium Citri Reticulatae Viride, 3.2~4.8 parts of Rhizoma Cyperis, 1.6~2.4 parts of Fructus Evodiaes,
4~6 parts of the Radix Aucklandiae, 1.6~2.4 parts of Cortex Magnoliae Officinalis, 4~6 parts of Herba Paederiaes,
4~6 parts of Aspongopuss, 8~12 parts of Radix Pseudostellariaes, 4~6 parts of Rhizoma Corydalis,
2.4~3.6 parts of Rhizoma Atractylodis, 2.4~3.6 parts of Rhizoma Coptidis.
2, the medicine of treatment gastritis according to claim 1, wherein the weight proportion of each component is:
4 parts on Pericarpium Citri Reticulatae Viride, 4 parts of Rhizoma Cyperis, 2 parts of Fructus Evodiaes, 5 parts of the Radix Aucklandiae,
2 parts of Cortex Magnoliae Officinalis, 5 parts of Herba Paederiaes, 5 parts of Aspongopuss, 10 parts of Radix Pseudostellariaes,
5 parts of Rhizoma Corydalis, 3 parts of Rhizoma Atractylodis, 3 parts of Rhizoma Coptidis.
3, the medicine of treatment gastritis according to claim 1 and 2 is characterized in that said medicament is an oral formulations.
4, the medicine of treatment gastritis according to claim 3 is characterized in that said medicament is a sugar free granule.
5, by the application of each described pharmaceutical composition of claim 1~4 in the medicine of the acute and chronic gastritis of preparation treatment.
6, a kind of method for preparing the medicine of the described treatment gastritis of claim 1, it comprises the steps:
A, get Pericarpium Citri Reticulatae Viride earlier,, sieve 50%~65% pulverizing wherein, standby;
B, residue Pericarpium Citri Reticulatae Viride and Fructus Evodiae, the Radix Aucklandiae, Rhizoma Cyperi, Rhizoma Atractylodis, Cortex Magnoliae Officinalis are extracted volatile oil with steam distillation, keep volatile oil, and be standby;
C, medicinal residues and Rhizoma Coptidis, Herba Paederiae, Aspongopus, Radix Pseudostellariae, Rhizoma Corydalis that the b step is carried behind the oil are fried in shallow oil altogether, fry in shallow oil altogether 2 times, add the water of 7 times of amounts for the first time, add the water of 6 times of amounts for the second time, decoct 1 hour at every turn, and medicinal liquid filters, and concentrates, and drying is collected the dry extract powder;
D, the Green Tangerine Peel with adding a step in the dry extract of c step, the volatile oil of b step and the adjuvant of pharmaceutically using always are made pharmaceutical preparation.
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