CN1478508A - A traditional Chinese medicine composition for treating fatty liver and preparation method thereof - Google Patents

Abstract

A Chinese medicine for treating fatty liver is prepared from 16 Chinese-medicinal materials including oriental wormwood, haw, wolfberry fruit, tangerine, etc through distilling, decocting, or alcohol extracting. Its advantage is high curative effect.

Description

A traditional Chinese medicine composition for treating fatty liver and preparation method thereof

field of invention

The invention relates to a traditional Chinese medicine composition, in particular to a traditional Chinese medicine composition for treating fatty liver, and to a preparation method of the composition.

Background technique

Fatty liver refers to the accumulation of fat in liver cells caused by various reasons, which is a common clinical phenomenon. The fat content of the normal liver accounts for about 3-5% of the wet weight of the liver. When fat is accumulated, the fat content of the liver can be as high as 40-50% of the liver weight. Under different etiologies, the fat accumulated in the liver can be triglycerides, phospholipids, glycolipids, cholesterol lipids, etc. But the vast majority of fatty liver is due to the accumulation of triglycerides.

In recent years, with the improvement of people's material living standards and the increase of alcohol consumption and high-fat diet, the incidence of fatty liver has been increasing year by year, and it has become one of the common clinical diseases in internal medicine. In particular, there are more and more young and middle-aged patients, which seriously affect their health, work and quality of life. Therefore, the clinical and experimental researches against fatty liver are increasing day by day. The prevention and treatment of fatty liver has become an increasingly important topic in clinical and basic research of traditional Chinese and Western medicine.

The latest research data on fatty liver at home and abroad show that modern medicine mainly focuses on the research of lipid metabolism, and has made some progress in the diagnosis methods and pathological research of fatty liver. In terms of treatment, currently commonly used therapeutic drugs are all systemic therapeutic drugs, which are not targeted to fatty liver. Therefore, the treatment of fatty liver with traditional Chinese medicine or integrated traditional Chinese and Western medicine has received more and more attention. Drugs and methods for treating fatty liver combined with systemic hyperlipidemia are increasing day by day. However, there are no successful precedents for drugs that can both lower lipids and improve the disordered state of lipid metabolism in the whole body, and can directly prevent liver fibrosis and sclerosing necrosis caused by fat accumulation in the liver. Therefore, it is an important topic at present to study new drugs that combine lipid-lowering and liver-protection, which can not only reduce blood lipid, but also regulate and restore liver damage caused by blood lipid accumulation.

The drug of the present invention is guided by the theory of traditional Chinese medicine, combined with the understanding of modern medicine on fatty liver and the latest progress of traditional Chinese medicine in treating fatty liver, through clinical observation, screening effective drugs, and according to the basic principles of clearing away heat and dampness, removing turbidity and detoxification, it is developed A new prescription for the treatment of fatty liver.

Contents of the invention

One object of the present invention is to disclose a new traditional Chinese medicine composition for treating fatty liver; another object of the present invention is to disclose a method for preparing a new traditional Chinese medicine composition for treating fatty liver.

The crude drug composition and proportioning of pharmaceutical composition of the present invention are as follows (by weight):

Capillary 240-300 parts by weight Cassia seed 240-300 parts by weight

Rhubarb 130-190 parts by weight Polyporus 240-300 parts by weight

Hawthorn 240-300 parts by weight Alisma 240-300 parts by weight

The crude drug composition of pharmaceutical composition of the present invention can add following medicine:

Trichosanthes 240-300 parts by weight Ligustrum lucidum 240-300 parts by weight

Eclipta 240-300 parts by weight Goji berries 240-300 parts by weight

Atractylodes 190-240 parts by weight Atractylodes 190-240 parts by weight

Chenpi 130-190 parts by weight Small thistle 130-190 parts by weight

Bupleurum 130-190 parts by weight

The crude drug composition of the pharmaceutical composition of the present invention can also be added on the basis of the above: 40-60 parts by weight of licorice.

Among them, cassia seeds are stir-fried, rhubarb is stewed with wine, Atractylodes macrocephala is fried with bran, Bupleurum is roasted with vinegar, atractylodes is fried with bran, and Ligustrum lucidum is better steamed with wine.

In the prescription, Yin Chen and Cassia Semen are used as monarch drugs to clear away heat and dampness, expel turbidity and detoxify. Among them, Yinchen enters the liver and gallbladder meridian, which is a special medicine for clearing heat, detoxifying and promoting dampness; Cassia seed enters the liver and kidney meridians, and has the functions of clearing liver and improving eyesight, diuresis and laxative. The two medicines are combined to form the merit of clearing the liver and detoxifying, promoting dampness and letting out turbidity, and are the king medicine of the prescription. Rhubarb, Alisma, Polyporus, and Hawthorn are the ministerial medicines in the prescription, promoting blood circulation and removing stasis, promoting stagnation and eliminating accumulation. Accumulation of dampness and heat, disharmony of veins, stagnation of blood stagnation, and accumulation of liver meridian are important reasons for the formation of fatty liver. Because of the lack of power of the king's medicine to promote dampness, remove stasis and clear turbidity, we use rhubarb, which is bitter and cold, to purify heat and poison, break up stagnation, remove blood stasis, cleanse the stomach, open a way for dampness and heat, and let the evil of dampness and heat go away from the stool. In the prescription, Alisma and Polyporus coryza are combined together, diuresis, expelling dampness and purging heat. Among them, Alisma diarrhea is sweet and cold, enters the kidney and bladder meridian, and its special function is to diuresis, dampness and heat. Polyporus chinensis is sweet and flat, enters the spleen, kidney and bladder meridian, and is also an essential product for diuresis and dampness, and diuresis without hurting yin. The combination of the two can promote the dampness and heat to go away with urination. Combined with rhubarb, it can make the damp heat disappear before and after. Hawthorn is good at changing diet, invigorating the spleen and stomach, regulating qi and eliminating blood stasis. It is used in this prescription to promote blood circulation and remove stasis, promote stagnation and eliminate accumulation. Combined with rhubarb, the power of removing stasis, dredging collaterals and stagnation is even better.

Adjuvant: Atractylodes atractylodes, Atractylodes macrocephala, tangerine peel, Bupleurum, Trichosanthes melon, wolfberry, privet, eclipta, and thistle. Because Alisma and Polyporus in the prescription are more effective in invigorating the spleen and transporting dampness than invigorating the spleen and transporting dampness, so Atractylodes atractylodes Rhizome and Atractylodes macrocephala are added to invigorate the spleen and stomach, dispel dampness and transform turbidity. Combined with tangerine peel to regulate qi and regulate the middle, dry damp and wake up the spleen. The combination of various medicines is used to assist the monarch and ministers in clearing heat, promoting dampness, purging turbidity and detoxification; Bupleurum bupleurum is used to soothe the liver qi and regulate the liver, and the other is to direct the power of the whole prescription to the sick place; Gualou is sweet, bitter and cold, enters the lung and stomach The large intestine meridian clears away phlegm and dissipates stagnation, smoothes the intestines and stagnates, and also has the function of soothing the liver and soothing the liver; Lycium barbarum is sweet and flat, nourishes the kidney and replenishes essence, nourishes the liver and improves eyesight. Ligustrum lucidum is bitter and sweet, and its merits are good for nourishing the liver and kidney, and strengthening the waist and knees. Eclipta licorice is sour and cool, and it is also a product for cooling blood, tonifying kidney and benefiting yin. The combination of the three nourishes the kidney and softens the liver, clears heat and purifies fire, nourishes the liver and clears the liver; thistle is sweet and cool, is a product for cooling blood, removing stasis, detoxification and dampness, and can assist monarchs and ministers in clearing heat, promoting dampness and eliminating phlegm.

Herbs: Glycyrrhiza reconcile various medicines, and harmonize the urgency and urgency as the traditional Chinese herbal medicine. In addition, Bupleurum can lead various medicines into the liver meridian, and also has the function of citing the meridian and repaying it.

In summary, the prescription of the present invention is composed of monarchs, ministers and assistants. Although there are many flavors of medicines, the compatibility is strict and orderly. Without injuring the blood, it has the functions of clearing heat and promoting dampness, detoxification and turbidity, removing stasis and softening the liver. Indications of fatty liver syndrome is damp-heat resistance, symptoms include body obesity, chest fullness, abdominal distension, liver pain, fatigue, general sleepiness, nausea, thirst, reluctance to drink, yellow urine, and uncomfortable stool , Red tongue with yellow thick fur, slippery and rapid pulse and other evidence. Or have a history of alcoholism, hepatitis, and significantly increased blood lipids.

The preparation method of this pharmaceutical composition:

Take the above sixteen flavors, take Bupleurum, Atractylodes atractylodes, Atractylodes macrocephala, and tangerine peel, grind them, add capillary wormwood and boil to extract the volatile oil, use β-cyclodext to refine the inclusion compound of the volatile oil, add water to decoct the dregs for 0.4-1 hour, filter, and filter the filtrate with After distillation, the aqueous solutions are combined; another Alisma, Ligustrum lucidum, Rhubarb, and Cassia are crushed, heated and refluxed with ethanol for three times, each time for 1-2 hours, the extracts are combined, filtered, and the filtrate is collected after recovering ethanol; Trichosanthes and other medicines are decocted twice with water, each time for 0.5-1.5 hours, combined with the decoction, filtered, the filtrate is combined with the above extract, concentrated and added with dextrin, stirred well, spray-dried; take the dry powder, add volatile oil β- Cyclodextrin inclusion compound, 10 parts by weight of protein sugar, after mixing evenly, finally through conventional procedures directly or adding pharmaceutically acceptable excipients to make clinically acceptable dosage forms, such as tablets, pills, chewables, oral Liquid formulations, capsules, granules, etc.

The composition has a remarkable effect on the treatment of fatty liver. It can significantly reduce the increase of blood lipid and the increase of fat content in the liver caused by drugs, high-fat diet and alcohol. Pathological changes have a significant improvement.

The composition preparation (Zhiganping granules) can significantly reduce serum TCH, TC, and LDL caused by ethionine and high-fat diet plus alcohol, and significantly increase the reduced HDL. The strength of the dose is equivalent to that of lovastatin, which can restore TCH and LDL to normal levels. It can significantly reduce the increase of intrahepatic TG and Gn content, and the effect strength of high dose is equivalent to that of lovastatin, and can restore intrahepatic TC and Cn to normal levels. It has a significant improvement effect on rat liver fatty degeneration, small focal damage, and inflammatory cell infiltration. Zhiganping granule can significantly reduce the increase of serum AST and ALT levels in mice caused by ip CCl ₁ , and the effect strength of high and medium doses is equivalent to that of biphenyl biphenyl.

The following experimental examples are used to further illustrate the present invention. The following materials are applicable to each experimental example. Material:

Drug under test: Zhiganping granule liquid: equivalent to 4.5g/m1 crude drug content, provided by Jiangsu Yangzhou Zhonghui Pharmaceutical Co., Ltd., batch number: 980620. The daily dosage for people is 85.5g crude drug. When used, it is mixed with water to form a suspension with the desired concentration.

Lovastatin: produced by North China Pharmaceutical Co., Ltd., batch number 971102. The daily dosage is 40mg.

Biphenyl Shuangzhi Dropping Pills: produced by Peking Union Medical College Pharmaceutical Factory, batch number: 980406. Human daily dosage is 75-150mg.

Dosage setting: The daily dosage for a 70kg person is 85.5g. After conversion, the high, small, and low doses of rats are 30.8g.kg, 15.4g/kg, and 7.7g/kg, respectively, which are equivalent to 25.2, 12.6, and 6.3 times the daily dose of a 70kg person, according to the volume of 1ml/100g body weight Oral administration. The high, medium, and low doses of mice are 44.5g/kg, 22.2g/kg, and 11.1g/kg, respectively, equivalent to 36.4, 18.2, and 9.1 times the daily dose of a 70kg person, and administered in a volume of 0.2ml/10g body weight medication. Water control group and positive control drug. All were administered intragastrically according to the same volume as above. The dose of lovastatin for rats was 7.2mg/kg, equivalent to 12.6 times of the daily dose for a 70kg person, and the dose of biphenyl difatide for mice was 11.7mg/kg, equivalent to 12.6 times of the daily dose. The dosage of biphenyl double fat mice was 11.7mg/kg, equivalent to 18.2 times of the daily dose of 70kg person.

Experimental animals: Kunming white mice, purchased from the Experimental Animal Center of Shandong Medical University, certificate number: Lu Dongzhi 970102. Wistar rats were purchased from the Experimental Animal Center of Shandong Province, certificate number: Ludongzhi No. 970101.

Test equipment: ultraviolet spectrophotometer UV-2100, cryogenic centrifuge, tissue homogenizer, etc.

Experimental Example 1. The composition preparation (Zhiganping Granules) on the influence of ethionine-induced fatty liver Wistar rats 60, male, were randomly divided into six groups according to body weight: normal control group, ethionine model control group, lovastatin control group, high-dose, low-dose and low-dose groups of Zhiganping. Intragastric administration of 1ml/100g, 10 people in a row. On the 8th day of administration, except for the normal control group, ethionine 250 mg/kg ¹ was given to each group ig. On the 10th day, fast for 12 hours, take blood from orbital vein, centrifuge at 2500rpm for 15min, get serum, measure CHO, TG, tlDL, LDL, the results are carried out between groups t test, see Table 1: rats were dissected immediately after blood was taken, and part was taken Liver homogenate was used to measure the content of glycogen Gn ^{2, 3} and ^TC1 in the liver tissue, and the results were carried out by t-test between groups, as shown in Table 2: another part of the liver was fixed in 10% formalin for histopathological examination: the specimen was excised Block→tissue fixation→post-fixation treatment→tissue block staining→paraffin sectioning method→step by step dehydration, transparency, 30 minutes each time needle→second wax immersion, 90 minutes for the first time, 30 minutes for the second time→embedding→slicing→ Adhesive → Dewaxing → Ethanol hydration at various levels → Washing → Conventional HE staining → Dehydration step by step, 20 minutes each time → Transparent secondary → Resin sealing → Examination under light microscope. The evaluation criteria are as follows, and the results are analyzed by Ridit, see Table 3. Table 1 The effect of Zhiganping Granules on rat body weight (g) (x±s, n=20) group dose TCH (mmol/L) TG (mmol/L) HDL (mmol/L) LDL (mmol/L )

(G/KG) Normal control group --- 2.573 ± 0.321 0.766 ± 0.310 0.536 ± 0.018 1.6810.183 Model control group --- 3.959 ± 0.914 ### 2.351 ± 0.833 ### 0.066##2.593 ± 0.93988888 #0.0072 2.553 ± 0.660 *** 1.609 ± 0.233 ###*0.358 ± 0.072 ###*1.847 ± 0.708 High dose 30.8 2.626 ± 0.651 ** 1.708 ± 0.366,070###* *1.915 ± 0.731 Dose 15.4 3.016 ± 0.500*1.676 ± 0.505 ###*0.340 ± 0.078 ### 2.241 ± 0.536#Low dose 7.7 3.297 ± 0.230 ###*2.051##0.390 ± 0.041#0.041# 2.286±0.345## Note: Compared with the normal control group #p<0.01, ##p<0.01, ###p<0.001

Compared with the model control group *p<0.05, *p<0.01, ***p<0.001

It can be seen from the results in Table 1 that TCH, TG, and LDL were all significantly increased, while HDL was significantly decreased after oral administration of ethionine to humans and mice. After administration of Zhiganping Granules, the elevated TCH, TC, and LDL can be significantly reduced, while the reduced HDL can be significantly increased. The intensity of the drug effect has a certain dose-dependent relationship. The strength is equivalent to that of lovastatin (0.0072g/kg), and it can restore TCH and LDL to normal levels. Table 2 The effect of Zhiganping granules on the changes of TG and Gn in the liver of rats induced by ethionine ( x±s, n=10) Group Dose TG(mmol/100g) Gn(g/100g)

(G/KG) Normal control group --- 0.900 ± 0.321 0.636 ± 0.120 model control group --- 1.446 ± 0.223 ### 1.238 ± 0.313 ### 0 0.0072 0.997 ± 0.711 ± 0.127 *** High dose 30.8 0.732 ± 0.330 *** 0.681 ± 0.237 *** Dose 15.061 ± 0.405*0.909 ± 0.209 ##*Low dose 7.2 1.251 ± 0.969 ± 0.240 ###*Note: p<0.01, ###p<0.001

Compared with the model control group *p<0.05, **p<0.01, ***p<0.001

It can be seen from the results in Table 2 that the contents of TG and Gn in the liver of rats were significantly increased after intragastric administration of ethionine. After administration of Zhiganping Granules, TG and Gn in the liver can be significantly reduced, and the intensity of its pharmacodynamic effect has an obvious dose-dependent relationship. The effect intensity of high dose (30.8g/kg) is equivalent to that of lovastatin (0.0072g/kg). , can restore the intrahepatic TG and Gn to normal levels.

Pathological examination report: Except for the slight swelling of the liver tissue in the model control group, there was no greasy feeling or other abnormalities. The appearance of the livers in the other groups showed no abnormality. The degree of lesions in each group was scored according to the following grades:

a. There is no obvious corresponding change in the slice, which is "-".

b. Corresponding pathological changes are occasionally seen on the film, the lesions are scattered or single, and the lesion range accounts for less than 1/4 of the entire field of view, which is "+".

c. The corresponding pathological changes are obvious, distributed in flakes or clusters, and the lesion range accounts for 1/4-1/2 of the full field of view, which is counted as "++".

d. The degree of corresponding lesion is serious, and the lesion is distributed in large sheets, occupying the entire lobe or more than 1/2 of the entire field of view, which is counted as "+++". Table 3 Effect of Liganping Granules on Ethionine-induced Liver Pathological Changes Groups Dose n Fatty degeneration Small focal ring death Inflammatory cell infiltration

(g/kg)-+++ +++-++ +++-++ +++ normal control group --- 10 10 1 0 9 1 0 0 2 7 1 0 model control group-- -10 10 5 4 0 ### 1 7 2 0 ### 0 8 20 Low dose 7.2 10 10 1 0 *** 7 7 0 ** 2 7 1 0 Dose 15.4 10 10 30 0** *7 7 0 0 ** 3 7 0 0*High doses 30.8 10 20 0 ** 9 9 0 *** 1 6 0*Luozetin 0.0072 10 10 0 ** 8 8 0** * 2 8 0 0*Note: Compared with the normal control group, p<0.001

Compared with the model control group *p<0.05, **p<0.01, ***p<0.001

It can be seen from the data in Table 3 that Zhiganping Granules can significantly improve the hepatic steatosis, focal necrosis and inflammatory cell infiltration in rats induced by ethionine.

Experimental example 2. the influence of this composition preparation (fatty liver flat granule) on alcoholic fatty liver

70 Wistar male rats, weighing 150-180g, 10 were taken as the normal control group, and the rest were given a mixed feed made of 79.5% corn flour, 20% lard, and 0.5% cholesterol, and 30% ethanol as a drink 5. After feeding for one month, blood was collected from some animals to measure CHO, TG, HDL, and LDL, and they were killed for histopathological examination to confirm that a fatty liver model had been formed. The rest of the animals are now randomly divided into 5 groups: model control group, biphenyl double lipid control group, Zhiganping high, medium and low dose groups. In addition to the normal control group, ig administration, 1ml/100g, once per person, for 30 consecutive days Day, normal control group ig equivalent amount of NS. After fasting for 12 hours after the last dose of medicine, blood was taken from orbital vein, centrifuged at 2500rpm for 15 minutes, serum was taken, CHO, TG, HDL, LDL were measured, the results were carried out: t-test between groups, see Table 4: rats were dissected immediately after blood was taken to take part Liver homogenate was used to measure glycogen 23 and TG in the liver tissue, and the results were carried out by t test between groups, as shown in Table 5: Take another part of the liver and fix it with 10% formalin for histopathological examination (the method is the same as before), and the evaluation criteria As follows, the results are analyzed by Ridit, see Table 6. The influence of table 4 Zhiganping granule on blood lipid changes in alcoholic fatty liver rats ( x±s, n=10) Group Dose TCH(mmol/L) TG(mmol/L) HDL(mmol/L) LDL(mmol/L)

(G/KG) Normal control group --- 2.460 ± 0.530 0.766 ± 0.310 0.659 ± 0.172 1.557 ± 0.600 Model control group --- 3.372 ± 1.079#2.447 ± 0.813#0.233 ± 0.061#1.689 ± 1.247 Luova他汀       0.0072   2.553±0.660      1.636±0.532###*  0.306±0.060###*     1.613±0.687高剂量         30.8     2.160±0.447**    1.640±0.319###*  0.366±0.070###***   1.193±0.607中Dose 15.4 2.574 ± 0.731 1.655 ± 0.451 ###*0.290 ± 0.081 1.503 ± 0.825 Low dosage 7.7 2.626 ± 0.617 1.842 ± 0.638 ± 0.052 1.364 ± 0.669 Note: #P <0.05, normally controlled group <0.05, 0 0.05, 0.001

Compared with the model control group *p<0.05, **p<0.05, **p<0.01

It can be seen from the results in Table 4 that the blood TCH and TG of rats with alcoholic fatty liver were significantly increased, HDL was significantly decreased, and LDL had no significant change. After administration of Zhiganping Granules, the elevated TCH and TG can be significantly reduced, while the reduced HDL can be significantly increased, and there is no significant effect on LDL.

Table 5 The effect of Zhiganping granules on the changes of TG and Gn in the liver of alcoholic fatty liver rats ( x±s, n=10)

Groups Dose TG(mmol/100g) Gn(mmol/100g)

(g/kg)

Normal control group --- 0.689±0.241 0.715±0.350

Model control group --- 2.201±0.700### 1.259±0.473##

Lovastatin 0.0072 0.781±0.454*** 0.820±0.416*

High dose 30.8 0.982±0.289#*** 0.723±0.330**

Medium dose 15.4 0.985±0.283#*** 0.997±0.348

Low dose 7.7 1.053±0.389#*** 1.251±0.553#

Note: Compared with the normal control group #p<0.05, ##p<0.01, ###p<0.001

Compared with the model control group *p<0.05, **p<0.01, ***p<0.001

It can be seen from the results in Table 5 that the contents of TG and Gn in the liver of rats with alcoholic fatty liver were significantly increased. After the administration of Zhiganping Granules, the elevated intrahepatic TG and Gn can be significantly reduced, and there is an obvious dose-dependent relationship in the intensity of the drug effect. )quite.

Pathological examination report: the capsule of the organs in the model group was slightly tense, the color of the slices was slightly yellow, and there was a slight greasy feeling, and the appearance of the other groups had no obvious abnormalities. Slicing is the same as above. Microscopic examination: the liver of the model group had fatty degeneration in varying degrees, the cytoplasm was empty and bright, and round lipid droplets of different sizes were scattered in the cytoplasm. The membranous area is obvious, distributed along the central area of the leaflet. Necrosis and inflammatory cell infiltration can be seen in some areas. No fibrotic hyperplasia was seen. The lesions in the other groups were not obvious. The ratings are as follows:

1. There is no obvious corresponding pathological change in the section, which is "-".

2. Corresponding pathological changes are occasionally seen on the film, the lesions are scattered or single, and the lesion range accounts for more than 1/4 of the entire field of view, which is "+".

3. The corresponding pathological changes are obvious, distributed in flakes or clusters, and the lesion range accounts for 1/4-1/2 of the entire visual field, which is counted as "++".

4. The severity of the corresponding lesion is serious, and the lesion is distributed in large sheets, occupying the entire lobe or more than 1/2 of the entire field of view, which is counted as "+++". Table 6 Effect of Zhiganping Granules on Pathological Changes of Alcoholic Fatty Liver Rats Group Dose n Fatty degeneration Small focal ring death Inflammatory cell infiltration

(g/kg)-+++ +++-++ +++-++++ normal control group --- 10 9 1 0 0 8 2 0 2 7 1 0 model control group-- -10 0 2 4 4 ### 0 6 4 0 ### 0 8 2 0 Low dose 7.2 10 9 1 0 *** 8 2 0 *** 2 8 0*Dose 15.4 10 8 2 0 0 *** 7 3 0 *** 3 7 0 0*High doses 30.8 10 0 0 0 *** 8 0 *** 4 0*Luo Suetine 0.0072 10 9 1 0 0 ** * 9 1 0 0*** 2 8 0 0*Note: Compared with the normal control group###p＜0.001

Compared with the model control group *p<0.05, **p<0.01, ***p<0.001

It can be seen from the data in Table 6 that Zhiganping Granules can significantly improve liver steatosis, small focal necrosis, and inflammatory cell infiltration in alcoholic fatty liver rats. Experimental example 3. the composition preparation (fatty liver flat granules) on the impact of liver damage caused by _CCl

72 Kunming mice of 18-20g, half male and half male, were randomly divided into six groups according to body weight: normal control group, model control group, biphenyl double lipid control group, high, medium and low dose groups of Zhiganping. Orally administered about 0.2ml/10g, 7 people in a row. 2 hours after the last dose, in addition to the normal control group, ip 0.25% CCl ₁ -olive oil 10ml/kg ^[6] , 24 hours later, blood was taken from the orbital vein, centrifuged at 2500rpm for 15 minutes, serum was taken, AST and ALT were measured, and the results were compared between groups. Test, see Table 7: Dissect the mice immediately after blood collection, take part of the liver, and fix it with 10% formalin for histopathological examination (the method is the same as before), the evaluation criteria are as follows, and the results are analyzed by Ridit, as shown in Table 8.

Table 7 Effect of Zhiganping Granules on serum AST and ALT in mice with liver injury caused by CCL ₁ (x±s, n=12)

Group Dose (g/kg) AST(U) ALT(U)

Normal control group --- 47.2±13.5 51.1±15.5###

Model control group --- 129.3±26.5### 206.5±15.4###***

Biphenyl double lipid group 0.0117 89.5±24.3###** 127.5±26.7###***

Low dose 44.5 86.8±24.0###** 125.6±19.8###***

Medium dose 22.2 92.6±17.5###** 129.8±19.2###***

High dose 11.2 99.1±30.6###* 140.3±20.3###*** Note: Compared with normal control group #p＜0.05, ###p＜0.001

Compared with the model control group *p<0.05, **p<0.01, ***p<0.001

It can be seen from the results in Table 7 that the levels of serum AST and ALT were significantly increased after ip administration of CCL ₁ to mice. After administration of Zhiganping Granules, the elevated serum AST and ALT can be significantly reduced, but the serum AST and ALT cannot be restored to normal levels, and the intensity of the drug effect has a certain dose-dependent relationship. 1. The effect strength of medium dose (22.2g/kg) is equivalent to that of biphenyl double fat (0.0117g/kg).

Pathological examination results: No obvious swelling, atrophy and obvious necrosis were found in the appearance of the specimens in the 6 groups, and there was no obvious greasy feeling on the cut surface. Microscopic examination: Compared with the normal control group, obvious liver cell necrosis, eosinophilic degeneration and inflammatory cell infiltration were seen in the model control group and each medication group, mainly located around the central vein and the portal area, and the lesions in the middle lobules were relatively mild. There was no fibrous tissue hyperplasia and fatty degeneration in each group. Compared with the injury control group, the degree of degeneration and necrosis in each treatment group was lighter, but the performance of cytoplasmic loosening was not much different among the groups. Injury manifestations such as hepatic cytoplasmic loosening, hepatocyte eosinophilia, and liver cell necrosis, and anti-injury performance of inflammatory cell infiltration are scored according to the following criteria:

Various damages of liver cells:

(-) indicates no obvious pathological changes.

(+) means that occasionally a few cells have corresponding pathological changes, and the distribution is scattered.

(++) indicates that about 1/3 of the cells have corresponding pathological changes, and the distribution is wide.

(+++) indicates that about half or more of the cells have corresponding pathological changes.

Inflammatory cell infiltration:

(-) indicates that almost no inflammatory cells were seen.

(+) indicates that inflammatory cells are occasionally seen in most fields of view.

(++) indicates that scattered distribution is easily seen in most fields of view.

(+++) indicates that inflammatory cells are more common and gather locally, replacing part of the cell structure. Table 8 Effect of Zhiganping Granules on liver pathological changes caused by CCL ₁

Dosage Hepatocyte Loosening Hepatocyte Eosinophilia Hepatocyte Necrosis Hepatocyte Infiltration Group

(g/kg) --- + + ++ +++ --- + + ++ +++ --- + + ++ +++ --- + + ++ +++ normal control group --- 12 3 8 1 0 8 1 0 0 7 5 0 0 0 4 8 0 0 Model Control Group-12 2 7 2 1 0 2 4 6 ### 0 5 4 3#3 7 1 Low dose 11.2 12 8 1 1 0 2 8 2 ### 1 4 6 1 ### 3 6 2 1 Dose 22.2 12 4 8 0 0 3 8 1 ### 0 ### 4 6 1 0 High Dose 44.5 12 8 2 0 01 9 2 ### 1 8 3 0 ##*3 7 1 1 Lianhebenzen Diplide Group 0.0117 8 2 6 0 0 4 4 0 ###*0 3 1 ## 3 6 2 1 Note : Compared with the normal control group ##p<0.01, ###p<0.001

Compared with the model control group *p<0.05

It can be seen from the data in Table 8 that after the mice were given CCL ₁ , the liver pathological changes were mainly hepatocyte eosinophilic degeneration and hepatocyte necrosis, and only the high-dose group (44.5g/kg) had a significant effect on hepatocyte necrosis after being given Zhiganping Granules. Significant improvement, the rest have no obvious effect. Experimental example 4. the influence of this composition preparation (zhiganping granule) on hyperlipidemia caused by high-fat diet

60 Wistar male rats, weighing 120-140g, were divided into 6 groups: normal control group, model control group, lovastatin control group, high-, medium-, and low-dose groups of Zhiganping, and all rats except the normal control group ig fat emulsion ^[7] ml/100g (10% cholesterol, 20% lard, 2% sodium cholate, 1% methylthiouracil), once a day, for 7 consecutive people. The normal control group received the same amount of NS. Administration began on the 8th day, 1ml/100g, once a day, for 10 consecutive days, and the normal control group ig the same amount of NS. Fast for 12 hours after the last dose. Blood was taken from the orbital vein, centrifuged at 2500rpm for 15min, and the serum was taken to measure CHO, TG, HDL, and LDL.

Table 9 The effect of Zhiganping granule on the change of blood fat in rats caused by high-fat diet ( x±s, n=10)

Group Dose TCH(mmol/L) TG(mmol/L) HDL(mmol/L) LDL(mmol/L)

(g/kg)

Normal control group --- 2.086±0.265 0.732±0.227 0.663±0.175 1.177±0.359

Model control group --- 4.038±0.392### 1.765±0.546### 0.427±0.092## 2.416±0.590###

Lovastatin 0.0072 2.126±0.832*** 1.325±0.541## 0.574±0.133* 0.811±0.840***

High dose 30.8 2.356±0.486*** 1.382±0.362### 0.591±0.112** 1.036±0.457***

Medium dose 15.4 2.432±0.360#*** 1.454±0.446### 0.555±0.119* 1.012±0.365***

Low dose 7.7 2.559±0.439##*** 1.531±0.117### 0.526±0.081#* 1.010±0.105***

Note: Compared with the normal control group #p<0.05, ##p<0.01, ###p<0.001

Compared with the model control group **p<0.05, **p<0.01, ***p<0.001

It can be seen from the results that after intragastric administration of rats with high-fat diet, TCH, TG, and LDL in the blood did not increase significantly, but HDL decreased significantly. After administration of Zhiganping Granules, the elevated TCH and LDL were significantly reduced, while the reduced HDL was significantly increased, and it also had a certain effect on reducing TG, but there was no statistical difference.

The results of the above experimental examples show that: (1) Zhiganping Granules can significantly reduce the TCH, TG, and LDL elevations caused by ethionine, while significantly increasing the reduced HDL. There is a certain dose-dependent relationship, and the high-dose (30.8g/kg) intensity of action has a certain subject-dependent relationship with the intensity of lovastatin. kg), it can restore TCH and LDL to normal levels. It has a significant reduction effect on the significant increase of TG and Gn content in the liver caused by ethionine, and its medicinal effect has an obvious dose-dependent relationship. Ding (0.0072g/kg) is equivalent, and can restore TG and Gn in the liver to normal levels. It has a significant improvement effect on ethionine-induced rat liver fatty degeneration, small focal necrosis, and inflammatory cell infiltration. (2) Zhiganping Granules can significantly reduce the elevated levels of serum TCH and TG in rats with alcoholic fatty liver. The strength is comparable to that of lovastatin (0.0072g/kg). It has a significant improvement effect on liver fatty degeneration, small focal necrosis and inflammatory cell infiltration in alcoholic fatty liver rats. (3) Zhiganping Granules can significantly reduce the increase of serum AST and ALT levels in mice caused by ip CCL ₁ , but cannot restore serum AST and ALT to normal levels, and its drug effect has a certain dose-dependence Relationship, high dose (44.5g/kg), medium dose (22.2g/kg) of the effect strength and biphenyl fat (0.0117g/kg) equivalent. For the pathological changes in the liver of mice caused by ip CCL ₁ , only the high-dose group (44.5mg/kg) can significantly improve the necrosis of liver cells, and the rest have no obvious effect. (4) Zhiganping Granules can significantly reduce the increase of TCH and LDL in the blood caused by high-fat diet, significantly increase the reduced HDL, and also have a certain reduction effect on TG, but there is no statistical difference .

The following embodiments can all achieve the effects of the above experimental examples. Example 1:

Capsicum chen 270g Cassia seeds 270g Rhubarb 162g

Polyporus 270g Hawthorn 270g Alisma 270g

Among them, cassia seeds are stir-fried, and rhubarb is stewed with wine.

Extract volatile oil by decocting capillary, and use β-cyclodext to refine clathrate of volatile oil; take Alisma, rhubarb, and cassia seeds, grind them, heat and reflux with ethanol to extract three times, each time for 1.5 hours, combine the extracts, filter, and recover the ethanol from the filtrate Collect in another container; take Polyporus and Hawthorn and add water to decoct twice, each time for 1 hour, combine the decoction, filter, concentrate, add 250g of dextrin, stir well, and spray dry; take dry powder, add volatile oil β-cyclodextrin Inclusion compound, protein sugar 10g, after mixing evenly, dry granulation to make 500g of granules to obtain granules. Each gram is equivalent to 3 grams of the original medicinal material, 8g in each bag, orally, 8g each time, 3 times a day, or as directed by the doctor. Example 2:

Capsicum chen 270g Cassia seeds 270g Rhubarb 162g

Polyporus 270g Hawthorn 270g Alisma 270g

Gualou 270g Ligustrum lucidum 270g Eclipta 270g

Wolfberry 270g Atractylodes 216g Atractylodes 216g

Chenpi 162g Small thistle 162g Bupleurum 162g

Among them, cassia seeds are stir-fried, rhubarb is stewed with wine, Atractylodes macrocephala is fried with bran, Bupleurum is roasted with vinegar, atractylodes is fried with bran, and Ligustrum lucidum is steamed with wine.

Take the above fifteen flavors, take Bupleurum, Atractylodes Rhizome, Atractylodes Rhizoma Atractylodes Rhizoma Atractylodes Rhizoma Atractylodes Rhizoma Atractylodes Rhizoma Atractylodes Rhizoma Atractylodes Rhizoma Atractylodes Rhizoma Atractylodes Rhizoma Atractylodes Rhizoma Atractylodes Rhizoma Atractylodes Rhizoma Atractylodes Rhizoma Atractylodes Rhizoma Atractylodes Atractylodes Rhizoma Atractylodes Rhizoma Atractylodes Atractylodes Rhizoma Atractylodes Atractylodes Rhizoma Atractylodes Atractylodes Atractylodes Rhizoma Atractylodes Atractylodes Atractylodes Atractylodes Atractylodes Atractylodes Atractylodes Atractylae Atractylodes Atractylodes Atractylodes Atractylodes Atractylodes Atractylodes Atractylodes oriba is 0.5 hour, filter, filtrate and distillation Combine the aqueous solutions; take another Alisma, Ligustrum lucidum, rhubarb, and cassia seeds, grind them, heat and reflux with ethanol for three times, 1.5 hours each time, combine the extracts, filter, and collect the ethanol from the filtrate in another device; then take Trichosanthes and other The drug is decocted twice with water, each time for 1 hour, the decoction is combined, filtered, the filtrate is combined with the above extract, concentrated, added 250g of dextrin, stirred well, spray-dried; take the dry powder, add β-cyclodextrin for clathrate 10g of protein sugar, mixed evenly, dry granulated to make 1000g of granules to obtain granules. Each gram is equivalent to 3 grams of the original medicinal material, 8g in each bag, orally, 8g each time, 3 times a day, or as directed by the doctor.

Example 3:

Capsicum chen 270g Cassia seeds 270g Rhubarb 162g

Polyporus 270g Hawthorn 270g Alisma 270g

Gualou 270g Ligustrum lucidum 270g Eclipta 270g

Wolfberry 270g Atractylodes 216g Atractylodes 216g

Chenpi 162g Small thistle 162g Bupleurum 162g Licorice 54g

Among them, cassia seeds are stir-fried, rhubarb is stewed with wine, Atractylodes macrocephala is fried with bran, Bupleurum is roasted with vinegar, atractylodes is fried with bran, and Ligustrum lucidum is steamed with wine.

Take the above sixteen flavors, take Bupleurum, Atractylodes Rhizome, Atractylodes Rhizoma Atractylodes Rhizoma Atractylodes Rhizoma Atractylodes Rhizoma Atractylodes Rhizoma Atractylodes Rhizoma Atractylodes Rhizoma Atractylodes Rhizoma Atractylodes Rhizoma Atractylodes Rhizoma Atractylodes Rhizoma Atractylodes Rhizoma Atractylodes Rhizoma Atractylodes Rhizoma Atractylodes Rhizoma Atractylodes Rhizoma Atractylodes Atractylodes Rhizoma Atractylodes Atractylodes Rhizoma Atractylodes Atractylodes Rhizoma Atractylodes Atractylodes Rhizoma Atractylodes Atractylodes Atractylodes Atractylodes Atractylodes Rhizoma Atractylodes Atractylodes Atractylodes Atractylodes Atractylae Atractylodes Atractylodes Atractylodes Atractylodes Atractylodes oriba is 0.5 hour, filter, filtrate and distillation Combine the aqueous solutions; take another Alisma, Ligustrum lucidum, rhubarb, and cassia seeds, grind them, heat and reflux with ethanol for three times, 1.5 hours each time, combine the extracts, filter, and collect the ethanol from the filtrate in another device; then take Trichosanthes and other The drug is decocted twice with water, each time for 1 hour, the decoction is combined, filtered, the filtrate is combined with the above extract, concentrated, added 250g of dextrin, stirred well, spray-dried; take the dry powder, add β-cyclodextrin for clathrate 10g of protein sugar, mixed evenly, dry granulated to make 1000g of granules to obtain granules. Each gram is equivalent to 3.56 grams of the original medicinal material, 8g in each bag, orally, 8g each time, 3 times a day, or as directed by the doctor. Example 4:

Capsicum chen 260g Cassia seeds 260g Rhubarb 172g

Polyporus 260g Hawthorn 260g Alisma 280g

Gualou 280g Ligustrum 280g Eclipta 280g

Lycium barbarum 250g Atractylodes atractylodes 226g Atractylodes atractylodes 206g

Chenpi 172g Small thistle 170g Bupleurum 150g Licorice 58g

Among them, cassia seeds are stir-fried, rhubarb is stewed with wine, Atractylodes macrocephala is fried with bran, Bupleurum is roasted with vinegar, atractylodes is fried with bran, and Ligustrum lucidum is steamed with wine.

Take the above sixteen flavors, take Bupleurum, Atractylodes Rhizome, Atractylodes Rhizoma Atractylodes Rhizoma Atractylodes Rhizoma Atractylodes Rhizoma Atractylodes Rhizoma Atractylodes Rhizoma Atractylodes Rhizoma Atractylodes Rhizoma Atractylodes Rhizoma Atractylodes Rhizoma Atractylodes Rhizoma Atractylodes Rhizoma Atractylodes Rhizoma Atractylodes Rhizoma Atractylodes Rhizoma Atractylodes Atractylodes Rhizoma Atractylodes Atractylodes Rhizoma Atractylodes Atractylodes Rhizoma Atractylodes Atractylodes Atractylodes Atractylodes Rhizoma Atractylodes Atractylodes Atractylodes Atractylodes Rhizoma Atractylodes Atractylodes Atractylodes Atractylodes Rhizoma Atractylodes Atractylodes Atractylodes Atractylodes Atractylodes Atractylodes Atractylodes Atractylodes M or M or Mt. Combine the aqueous solutions; take another Alisma, Ligustrum lucidum, rhubarb, and cassia seeds, grind them, heat and reflux with ethanol for three times, 1.5 hours each time, combine the extracts, filter, and collect the ethanol from the filtrate in another device; then take Trichosanthes and other The drug is decocted twice with water, each time for 1 hour, the decoction is combined, filtered, the filtrate is combined with the above extract, concentrated, added 250g of dextrin, stirred well, spray-dried; take the dry powder, add β-cyclodextrin for clathrate Material, protein sugar 10g, after mixing evenly, dry granulate to make 500 soft capsules, each gram is equivalent to 3.56 grams of the original medicinal material, each capsule contains 4g, orally, two capsules at a time, 3 times a day, or as directed by the doctor.

Claims (12)

1, a kind of Chinese medicine compositions for the treatment of fatty liver is characterized in that this pharmaceutical composition made by following raw material medicaments:

Herba Artemisiae Scopariae 240-300 weight portion Semen Cassiae 240-300 weight portion

Radix Et Rhizoma Rhei 130-190 weight portion Polyporus 240-300 weight portion

Fructus Crataegi 240-300 weight portion Rhizoma Alismatis 240-300 weight portion.

2, pharmaceutical composition as claimed in claim 1 is characterized in that this pharmaceutical composition made by following raw material medicaments:

Herba Artemisiae Scopariae 270 weight portion Semen Cassiaes 270 weight portions

Radix Et Rhizoma Rhei 162 weight portion Polyporus 270 weight portions

Fructus Crataegi 270 weight portion Rhizoma Alismatis 270 weight portions.

3, pharmaceutical composition as claimed in claim 1 is characterized in that this pharmaceutical composition made by following raw material medicaments:

Herba Artemisiae Scopariae 240-300 weight portion Semen Cassiae 240-300 weight portion

Radix Et Rhizoma Rhei 130-190 weight portion Polyporus 240-300 weight portion

Fructus Crataegi 240-300 weight portion Rhizoma Alismatis 240-300 weight portion

Fructus Trichosanthis 240-300 weight portion Fructus Ligustri Lucidi 240-300 weight portion

Herba Ecliptae 240-300 weight portion Fructus Lycii 240-300 weight portion

Rhizoma Atractylodis 190-240 weight portion Rhizoma Atractylodis Macrocephalae 190-240 weight portion

Pericarpium Citri Reticulatae 130-190 weight portion Herba Cirsii 130-190 weight portion

Radix Bupleuri 130-190 weight portion.

4, pharmaceutical composition as claimed in claim 3 is characterized in that this pharmaceutical composition made by following raw material medicaments:

Herba Artemisiae Scopariae 270 weight portion Semen Cassiaes 270 weight portions

Radix Et Rhizoma Rhei 162 weight portion Polyporus 270 weight portions

Fructus Crataegi 270 weight portion Rhizoma Alismatis 270 weight portions

Fructus Trichosanthis 270 weight portion Fructus Ligustri Lucidi 270 weight portions

Herba Ecliptae 270 weight portion Fructus Lycii 270 weight portions

The Rhizoma Atractylodis 216 weight portion Rhizoma Atractylodis Macrocephalaes 216 weight portions

Pericarpium Citri Reticulatae 162 weight portion Herba Cirsiis 162 weight portions

Radix Bupleuri 162 weight portions.

5, pharmaceutical composition as claimed in claim 1 is characterized in that this pharmaceutical composition made by following raw material medicaments:

Herba Artemisiae Scopariae 240-300 weight portion Semen Cassiae 240-300 weight portion

Radix Et Rhizoma Rhei 130-190 weight portion Polyporus 240-300 weight portion

Fructus Crataegi 240-300 weight portion Rhizoma Alismatis 240-300 weight portion

Fructus Trichosanthis 240-300 weight portion Fructus Ligustri Lucidi 240-300 weight portion

Herba Ecliptae 240-300 weight portion Fructus Lycii 240-300 weight portion

Rhizoma Atractylodis 190-240 weight portion Rhizoma Atractylodis Macrocephalae 190-240 weight portion

Pericarpium Citri Reticulatae 130-190 weight portion Herba Cirsii 130-190 weight portion

Radix Bupleuri 130-190 weight portion Radix Glycyrrhizae 40-60 weight portion

6, pharmaceutical composition as claimed in claim 5 is characterized in that this pharmaceutical composition made by following raw material medicaments:

Herba Artemisiae Scopariae 270 weight portion Semen Cassiaes 270 weight portions

Radix Et Rhizoma Rhei 162 weight portion Polyporus 270 weight portions

Fructus Crataegi 270 weight portion Rhizoma Alismatis 270 weight portions

Fructus Trichosanthis 270 weight portion Fructus Ligustri Lucidi 270 weight portions

Herba Ecliptae 270 weight portion Fructus Lycii 270 weight portions

The Rhizoma Atractylodis 216 weight portion Rhizoma Atractylodis Macrocephalaes 216 weight portions

Pericarpium Citri Reticulatae 162 weight portion Herba Cirsiis 162 weight portions

Radix Bupleuri 162 weight portion Radix Glycyrrhizaes 54 weight portions.

7, pharmaceutical composition as claimed in claim 5 is characterized in that this pharmaceutical composition made by following raw material medicaments:

Herba Artemisiae Scopariae 260 weight portion Semen Cassiaes 260 weight portions

Radix Et Rhizoma Rhei 172 weight portion Polyporus 260 weight portions

Fructus Crataegi 260 weight portion Rhizoma Alismatis 280 weight portions

Fructus Trichosanthis 280 weight portion Fructus Ligustri Lucidi 280 weight portions

Herba Ecliptae 280 weight portion Fructus Lycii 250 weight portions

The Rhizoma Atractylodis 226 weight portion Rhizoma Atractylodis Macrocephalaes 206 weight portions

Pericarpium Citri Reticulatae 172 weight portion Herba Cirsiis 170 weight portions

Radix Bupleuri 150 weight portion Radix Glycyrrhizaes 58 weight portions.

8, as claim 1,2,3,4,5,6 or 7 described pharmaceutical compositions, it is characterized in that the preferred stewed with wine Radix Et Rhizoma Rhei of Radix Et Rhizoma Rhei in this pharmaceutical composition, Semen Cassiae is preferably fried Semen Cassiae.

9, as claim 3,4,5,6 or 7 described pharmaceutical compositions, it is characterized in that the preferred Rhizoma Atractylodis Macrocephalae (parched with bran) of the Rhizoma Atractylodis Macrocephalae in this pharmaceutical composition, the preferred Radix Bupleuri (processed with vinegar) of Radix Bupleuri, the preferred parched with bran Rhizoma Atractylodis of Rhizoma Atractylodis, the preferred Fructus Ligustri Lucidi (steamed with wine) of Fructus Ligustri Lucidi are best.

10, as claim 1,2,3,4,5,6 or 7 or described pharmaceutical composition, it is characterized in that this pharmaceutical composition also can add excipient and make clinical acceptable forms.

11, as claim 3,4,5,6 or 7 described preparation of drug combination methods, it is characterized in that this method is: get Radix Bupleuri, Rhizoma Atractylodis, the Rhizoma Atractylodis Macrocephalae, Pericarpium Citri Reticulatae pulverizing, add Herba Artemisiae Scopariae and decoct extraction volatile oil, volatile oil is with beta-schardinger dextrin-system clathrate, medicinal residues decoct with water 0.4-1 hour, filter, filtrate merges with the distillation rear solution; Other gets Rhizoma Alismatis, Fructus Ligustri Lucidi, Radix Et Rhizoma Rhei, Semen Cassiae pulverizing, extracts three times with alcohol heating reflux, and each 1-2 hour, merge extractive liquid, filtered, device collection in addition behind the filtrate recycling ethanol; Get all the other medicines such as Fructus Trichosanthis again and decoct with water twice, each 0.5-1.5 hour, collecting decoction filtered, and filtrate merges with said extracted liquid, concentrates the adding dextrin, stirs evenly spray drying; Get dry powder, add volatile oil beta cyclodextrin inclusion complex, protein sugar 10 weight portions are behind the mix homogeneously, at last directly or add pharmaceutically acceptable excipient and make clinical acceptable forms, as tablet, oral liquid, capsule, granule through conventional operation.

12, preparation of drug combination method as claimed in claim 11, it is characterized in that this method is: get Radix Bupleuri, Rhizoma Atractylodis, the Rhizoma Atractylodis Macrocephalae, Pericarpium Citri Reticulatae pulverizing, add Herba Artemisiae Scopariae and decoct extraction volatile oil, volatile oil is with beta-schardinger dextrin-system clathrate, medicinal residues decoct with water 0.5 hour, filter, filtrate merges with the distillation rear solution; Other gets Rhizoma Alismatis, Fructus Ligustri Lucidi, Radix Et Rhizoma Rhei, Semen Cassiae pulverizing, extracts three times with alcohol heating reflux, and each 1.5 hours, merge extractive liquid, filtered, device collection in addition behind the filtrate recycling ethanol; Get all the other medicines such as Fructus Trichosanthis again and decoct with water twice, each 1 hour, collecting decoction filtered, and filtrate merges with said extracted liquid, concentrated adding dextrin 250 weight portions, stirred evenly spray drying; Get dry powder, add volatile oil beta cyclodextrin inclusion complex, protein sugar 10 weight portions, behind the mix homogeneously, dry granulation gets granule.