CN1282475C - Combination of medication for treating gallbladder disease and preparation method - Google Patents

Abstract

The present invention relates to a medicine composition for treating gallbladder disease, which is mainly prepared from herba lysimachiae, cape jasmine fruit, phellodendron bark, semen cassiae and chuanxiong rhizome. Cortex magnoliae officinalis, tree peony bark, dry radix ginseng, cassia twig, etc. can be added. The prepared oral preparation is mainly used for clearing away heat, eliminating dampness, promoting Qi circulation, resolving stagnation, activating blood circulation, dissipating blood stasis, benefiting Qi and strengthening the body resistance. The condition that a medicine for clearing away heat and expelling dampness can be administered for a long time so that the vital Qi is consumed can be prevented. The medicine composition has the functions of taking a temporary solution and effecting a permanent cure, and the curative effect is fully enhanced.

Description

A kind of pharmaceutical composition for treating gallbladder disease and preparation method thereof

technical field

The invention belongs to a pharmaceutical composition for treating gallbladder disease derived from traditional Chinese medicine and a preparation method thereof, in particular to a pharmaceutical composition for treating cholelithiasis and/or cholecystitis and an industrially applicable preparation method thereof.

Background technique

Cholelithiasis is characterized by right upper quadrant pain, right shoulder pain, bitter mouth and constipation, or yellow body and eyes as the main clinical manifestations. Chinese medicine believes that the gallbladder is attached to the liver and is the organ of the middle essence. Bile is "formed by borrowing the remaining qi from the liver, overflowing into the gallbladder and accumulating". Emotional disorders, stagnation of liver qi, or stagnation of qi for a long time, stagnation of qi and blood stasis; improper diet, excessive fat and sweetness, dysfunction of the spleen, internal stagnation of dampness and heat, poor drainage, etc., resulting in liver failure and gallbladder failure Falling, stagnation of qi and blood, pain if blocked; damp heat fumigation, resulting in jaundice; stagnation of qi and blood stasis, incomprehensible accumulation of damp and heat, poor excretion of bile, eventually forming sand and gravel. The drugs related to the treatment of cholelithiasis in the prior art, Lidanshi Paishi Tablets, Lidanshi Granules, Danshitong Capsules, etc., are mostly medicines that are simply limited to clearing away heat and removing dampness. For example: 03119335.8 "Paishi powder and its preparation and application method", including Desmodium, Hyjinsha, Curcuma longa, Turmeric, Polygonum cuspidatum, Raspberry, Patrinia, Atractylodes rhubarb, Rhubarb, Ume, Gardenia, Citrus aurantium, Qingpi, Cyperus Cyperi, Bupleurum, Woody Fragrance, Clematis. Another example: 99111536.8 "Drugs for the treatment of calculus", including gallinacea, desmodium, sea ginseng, knotweed, gentian, artemisia annua, capillary wormwood, skullcap, phellodendron, gardenia, turmeric, aurantium, Biancu, Paeonol, Radix Paeoniae Rubra, Plantago Seed, Guangxixiang, Toosendan, White Poria, Alisma, Polyporus, Papaya, Nanbupleurum, Rhubarb, etc. Another example: Lidan Paishi Tablets contain betel nut and Glauber's salt. Chewing betel nut can induce and aggravate the onset of bronchial asthma (excerpted from "Chinese Journal of Tuberculosis and Respiratory" 2001 Issue 03). People who chew betel nut have a high incidence of oral cancer, and betel nut is also related to fibrosis of the oral submucosa, which is a hidden danger of malignant transformation of the mouth, pharynx, and esophagus ("Foreign Medicine·Medical Geography Volume" 1998 02 issue). According to the theory of traditional Chinese medicine, Glauber's salt is a purgative agent, and long-term use can cause vomiting, diarrhea, dehydration, and disturbance of water and electrolyte balance, which can easily damage the righteousness. In short, for patients with cholelithiasis, due to liver and gallbladder damp-heat stagnation for a long time, long-term use of heat-clearing and damp-dispelling medicines will consume righteousness, and easily damage the spleen and stomach, resulting in spleen-stomach qi deficiency, which may make it more difficult to treat damp-heat, or affect the stability of the curative effect. Therefore, simply clearing away heat and removing dampness will treat the symptoms but not the root cause.

Contents of the invention

The technical problem to be solved by the present invention is to study the pharmaceutical composition for treating cholelithiasis and/or cholecystitis and its industrially applicable preparation method. The medicinal composition not only has a significant effect of clearing away heat and removing dampness, but also can soothe the liver and regulate qi, promote blood circulation and remove blood stasis. The wet medicine consumes the righteousness, but also has the functions of invigorating Qi and strengthening the body, improving the human body's ability to eliminate evil, treating both symptoms and root causes, and comprehensively improving the therapeutic effect.

In order to solve the above problems, the present invention provides the following technical solutions.

A pharmaceutical composition for treating gallbladder disease, characterized in that it is mainly made of the following raw materials by weight: Desmodium 5-10 parts Gardenia 2.5-5 parts Phellodendron 1.5-3 parts Cassia 2-4 parts Rhizoma Chuanxiong 1.5- 3 parts; Its preparation method comprises the following steps:

1) Weighing raw materials Desmodium, Gardenia; Phellodendron Cortex, Semen Cassiae, Rhizoma Chuanxiong, set aside;

2) extract the volatile oil from Rhizoma Chuanxiong and Desmodium in the weight ratio; the volatile oil is clathrated with β-cyclodextrin, and the volatile oil clathrate B is dried for subsequent use;

3) Merge the dregs after extracting the volatile oil with gardenia, phellodendron, and cassia seeds, extract with water to obtain a water extract; concentrate the water extract, add ethanol, let stand, take the supernatant, reclaim ethanol, and concentrate the extract , mixed with the volatile oil inclusion complex B of 2), to obtain the active ingredient of the medicament of the present invention.

The pharmaceutical composition of the present invention, wherein the crude drug also includes: Magnolia officinalis 2-4 parts, Cortex Moutan 1.5-3 parts, Sun-dried ginseng 1-2 parts, Guizhi 1.5-3 parts; its preparation method comprises the following steps:

1) Weigh the raw materials Desmodium chinensis, gardenia, Cortex Phellodendri, Semen Cassiae, Rhizoma Chuanxiong, Magnolia Officinalis, Cortex Moutan, Sun-dried Ginseng, Guizhi, and set aside;

2) Distilling the Cortex Moutan in the weight ratio to obtain paeonol crystals; the paeonol crystals are clad with β-cyclodextrin to obtain inclusion A, which is set aside; the paeonol crystals in the weight ratio Extract volatile oil from Guizhi, Chuanxiong and Desmodium; volatile oil is encapsulated with β-cyclodextrin to obtain inclusion B, which is set aside;

3) Alternatively, mix Moutan Cortex, Guizhi, Chuanxiong, Desmodium, and Yinchen for steam distillation, collect the distillate D, and set aside;

4) Merge the dregs of extracted volatile oil with gardenia, Phellodendron cork, Semen Cassiae, Magnolia officinalis, and Sun-dried Ginseng, and extract with water to obtain a water extract; concentrate the water extract, add ethanol, let it stand, and take the supernatant, Recover ethanol and concentrate to obtain the extract of water extract;

5) Mix the extract extract of 4) with the inclusion complex A and inclusion complex B of 2) to obtain the active component of the medicine of the present invention; or, mix the extract extract of 4) with the distillate D of 3) , to obtain the active ingredient of the medicament of the present invention.

The aforementioned pharmaceutical composition, wherein the raw materials also include: 2.5-5 parts of capillary, 1-2 parts of rhubarb, 1.5-3 parts of Pinellia chinensis, 2.5-5 parts of hawthorn, 1.5-3 parts of peach kernel, and 1-2 parts of safflower , and one or more mixtures selected from 2.5-5 parts of Rhizoma Cyperus, 1.5-3 parts of Citrus Fructus Citrus Fructus and 1.5-3 parts of Muxiang.

The dosage of each component of the pharmaceutical composition is preferably: 5-10 parts of Desmodium, 2.5-5 parts of Gardenia, 1.5-3 parts of Cortex Phellodendri, 2-4 parts of Semen Cassiae, 1.5-3 parts of Rhizoma Chuanxiong, 2-4 parts of Magnolia officinalis 1.5-3 parts of peony bark, 1-2 parts of raw sun-dried ginseng, 1.5-3 parts of cassia twig, 2.5-5 parts of capillary, 1-2 parts of rhubarb, 1.5-3 parts of Pinellia chinensis, 2.5-5 parts of hawthorn , 1.5-3 parts of peach kernel, 1-2 parts of safflower, 2.5-5 parts of Cyperus cyperi, 1.5-3 parts of Citrus aurantium, and 1.5-3 parts of woody fragrance.

The dosage of each component of the pharmaceutical composition is more preferably: 5 parts of Desmodium, 2.5 parts of Gardenia, 1.7 parts of Cortex Phellodendri, 2 parts of Semen Cassiae, 1.7 parts of Rhizoma Chuanxiong, 2 parts of Magnolia officinalis, 1.7 parts of Cortex Moutan, 1 part of Sun-dried Ginseng 1.7 parts of Guizhi, 2.5 parts of capillary, 1 part of rhubarb, 1.7 parts of Pinellia chinensis, 2.5 parts of hawthorn, 1.7 parts of peach kernel, 1 part of safflower, 2.5 parts of Cyperus cyperi, 1.7 parts of Citrus aurantium, and 1.7 parts of woody fragrance.

The preparation method of the pharmaceutical composition of the present invention comprises the following steps:

1) Weigh the raw materials Desmodium, Gardenia, Phellodendron, Cassia, Rhizoma Chuanxiong, Magnolia officinalis, Cortex Moutan, Sun-dried Ginseng, Guizhi, Yinchen, Rhubarb, Pinellia, Peach Kernel, Safflower, Hawthorn, Cyperus Cyperi, Citrus aurantium or/and woody, for later use; 2) extract the cassia seed, magnolia officinale, sun-dried ginseng, rhubarb and pinellia chinensis with 5-80% ethanol as solvent, concentrate to obtain alcohol Extraction of the extract; 3) steam distilling the Cortex Moutan in the weight ratio to obtain paeonol crystals; the paeonol crystals are clad with β-cyclodextrin to obtain clathrate A, which is set aside; The volatile oil is extracted from capillary, osmanthus twig, chuanxiong and Desmodium in the weight ratio, and one or more raw materials selected from Muxiang, Rhizoma Cyperi and Fructus Aurantii; the volatile oil is encapsulated with β-cyclodextrin , to obtain inclusion B, for later use; 4) or, mix Moutan bark, woody root, Cyperus cyperi, Citrus aurantium, Guizhi, Chuanxiong, Desmodium, and capillary for steam distillation, and collect distillate D for later use; 5 ) combine gardenia, phellodendron, peach kernel, safflower and hawthorn, extract with water to obtain a water extract; concentrate the water extract, add ethanol, adjust the alcohol content to 50-80%, let stand, take the supernatant, and recover Ethanol, after concentrating, gets water extract extract; 6) takes 5) water extract extract, 2) alcohol extract extract, 3) inclusion complex A and inclusion complex B mix, obtain the present invention The active component of the medicine; or, the water extract extract of 5) is mixed with the alcohol extract extract of 2) and the distillate D of 4) to obtain the active component of the medicine of the present invention.

In the preferred preparation method of the pharmaceutical composition: extract the cassia seeds, magnolia officinalis officinale, sun-dried ginseng, rhubarb and pinellia chinensis with 50-60% ethanol as a solvent, and concentrate to a relative density of about 1.10- After 1.20°C (50°C), the alcohol extract extract was obtained; steam distilled the Moutan cortex with the weight ratio to obtain paeonol crystals; the paeonol crystals were wrapped with β-cyclodextrin and dried Material A, standby; the capillary, osmanthus twig, chuanxiong and Desmodium in the weight ratio, and one or more raw materials selected from woody, Cyperus and Fructus Citrifolia, extract volatile oil; volatile oil is extracted with β -Cyclodextrin inclusions, dry volatile oil inclusions B, set aside; extract gardenia, phellodendron, peach kernel, safflower and hawthorn with water to obtain a water extract; concentrate the water extract to a relative density of about 1.10-1.20 (50 ℃) After the extract, add ethanol, adjust the alcohol content to 55-70% and let stand, take the supernatant, recover the ethanol, concentrate to a relative density of about 1.10-1.20 (50°C), add the extract of the alcohol extract, Mixing and drying to obtain medicinal powder; taking the medicinal powder and mixing with inclusion complex A and inclusion complex B to obtain the active component of the medicine of the present invention; mixing the active component of the medicine of the present invention with pharmaceutically acceptable excipients.

In the preparation method of the preferred pharmaceutical composition: the weight ratio of magnolia officinalis, rhubarb, cassia, sun-dried ginseng, and Pinellia chinensis is soaked with 60% ethanol for 24 hours, percolated, and the collection speed is 3ml/min, and the collection is 10 times Measure the ethanol percolation liquid, recover the ethanol to the extract with a relative density of about 1.15 (50°C); steam distill the Moutan cortex, collect 7 times the distillate, and collect the distilled aqueous solution in another container; refrigerate the distillate overnight and filter , to obtain paeonol crystals, add an appropriate amount of ethanol to dissolve, then use β-cyclodextrin for inclusion, dry the inclusions, grind them into fine powder A, and set aside; Extract the volatile oil with Desmodium chinensis and capillary wormwood, collect the aqueous solution after extracting the volatile oil in another device, use β-cyclodextrin inclusion for the volatile oil, dry the inclusion, and crush it into fine powder B for later use; extract the volatile oil residue and The dregs of Moutan cortex are decocted with gardenia, phellodendron, peach kernel, safflower, and hawthorn twice, each time for 2 hours, the decoction, the aqueous solution after extracting volatile oil and paeonol are combined, filtered, and the filtrate is concentrated to a relatively high temperature. The density is about 1.15 (50°C), add ethanol to adjust the alcohol content to 60%, let it stand for 24 hours, pour the supernatant to recover the ethanol and concentrate it to a relative density of about 1.15 (50°C), add alcohol extraction extract, mix and drying to obtain the active ingredient of the medicine of the present invention; the active ingredient of the medicine of the present invention is mixed with pharmaceutically acceptable adjuvants to make granules or capsules, tablets, mixtures, and syrups.

The treatment of cholelithiasis or gallbladder disease by the pharmaceutical composition of the present invention is not limited to the traditional methods of clearing heat and removing dampness, promoting gallbladder and expulsion of stones, but also using methods such as soothing the liver and regulating qi, promoting qi to relieve stagnation, promoting blood circulation and removing blood stasis, and other methods. When the bar is up, the liver blood is filled, the bile is released smoothly, and the damp heat is self-transformed. The treatment of cholelithiasis is mainly based on clearing away heat and removing dampness, promoting qi to relieve depression, and promoting blood circulation to remove blood stasis, and has received good curative effect.

In the prescription, Glycyrrhiza chinensis is sweet, bitter, and slightly cold, and it belongs to the liver, gallbladder, and bladder meridians. It is good at clearing dampness and heat in the liver, gallbladder, and bladder. Fructus Gardeniae is bitter and cold, returns to the liver and gallbladder meridians, has the function of clearing heat and promoting dampness, and is used for liver and gallbladder damp-heat syndrome. Phellodendron Phellodendri is bitter and cold, and returns to the kidney, bladder, and large intestine meridian. It has the function of clearing away heat and dampness, and cooperates with monarch medicine to strengthen the effect of clearing away heat and promoting dampness. Semen Cassiae is bitter, sweet, salty, slightly cold, and returns to the Liver and Large Intestine Meridian. Its function is to assist the monarch drug in clearing away heat and improving eyesight, moistening the intestines and laxative. Rhizoma Chuanxiong is pungent and warm, returns to the liver and gallbladder meridian, has the function of promoting blood circulation and promoting qi, dispelling wind and relieving pain, and is an adjuvant medicine. "Compendium of Materia Medica" says: "Chuanxiong blood qi medicine can dry dampness, stop diarrhea and dysentery, promote qi and relieve depression."

Magnolia officinalis in the prescription is bitter, pungent and warm, and belongs to the spleen, stomach and large intestine meridians. Coupled with Moutan bark, it enhances the effect of promoting blood circulation and removing blood stasis. Raw sun-dried ginseng is sweet and slightly bitter. It has great functions of invigorating vitality, nourishing the five internal organs, regulating the middle, clearing away heat and dampness, and promoting qi and activating blood. , easy to damage the spleen and stomach, resulting in deficiency of spleen and stomach qi, ginseng can invigorate qi and strengthen the body, improve the body's ability to eliminate evil, and has the effect of assisting and assisting, so it is also listed as an adjuvant drug. Guizhi is pungent, sweet, and warm. The use of this prescription seems to be contrary to the damp-heat pathogenesis of gallstones, but "The Classic of Shuzheng" says: "Guizhi can benefit the joints, warm the meridians and open the veins." "Medical Zhongzhong Shenxilu" said that it is a good medicine for soothing the liver. Cholelithiasis is difficult to resolve due to damp-heat stagnation for a long time, and Guizhi anti-adjuvant is beneficial to play the role of clearing heat and dampness, promoting qi and activating blood.

Capillary wormwood is bitter, pungent, and slightly cold, and returns to the spleen, stomach, liver, and gallbladder meridian. It is good at clearing damp and heat, and reducing jaundice. The effect of clearing heat and promoting dampness is even stronger when combined with Phellodendron Phellodendri. Rhubarb is bitter and cold, and it returns to the spleen, stomach, large intestine, and liver meridian. It has the function of purging heat and dredging the internal organs, cooling blood and detoxifying. Compatibility of rhubarb with magnolia bark and citrus aurantium (Xiaochengqi soup) can relieve heat knots. Pinellia pinellia is pungent and warm, and its merits are good at drying dampness and eliminating phlegm, lowering qi and eliminating fullness, reducing adverse flow and relieving vomiting. Cassia seeds are combined with rhubarb to assist the monarch medicine to clear away heat, and at the same time, it can significantly strengthen the effect of dampness and heat. The combined use of the four medicines of Yin Chen, Phellodendron Phellodendron, Rhubarb, and Semen Cassiae can further enhance the effects of the monarch drug on clearing away heat and dampness, promoting gallbladder and removing stones, and can be used as a minister drug together. Cyperi cyperi is pungent, slightly bitter, slightly sweet, flat, promotes qi and relieves depression. "Compendium of Materia Medica" records that "Cyphora cyperi can benefit the triple burner, relieve six stagnation, eliminate food accumulation, tarsal swelling and abdominal distension", "it is the foot Jueyin liver, less hands Yang Sanjiao qi component is the main drug, and it also stimulates the twelve meridian qi components." The woody fragrance is pungent, bitter, warm, promotes the circulation of qi and relieves pain, eliminates food and invigorates the spleen. Fructus Aurantii is bitter, pungent, sour, warm, dispelling qi and eliminating stagnation, dispelling blood stasis and dispelling mass. Magnolia bark, pinellia, Cyperus cyperi, Citrus aurantium, and woody fragrance soothe the liver and relieve depression, promote qi and relieve pain. Cortex Moutan and Ligusticum Chuanxiong, if combined with peach kernels that are bitter, sweet, and calm, return to the liver, large intestine meridian, promote blood circulation and remove blood stasis, and laxative, safflower that is pungent and warm, promote blood circulation, relieve pain, and sweet, slightly warm, Belonging to the spleen, stomach, liver meridian, function of digestion and harmonizing the stomach, hawthorn for promoting blood circulation and removing blood stasis, the effect of these five herbs for promoting blood circulation and removing blood stasis can be significantly strengthened, and combined with Qi-promoting medicine, it can treat Qi and blood at the same time, and the Qi and blood can flow smoothly. Damp heat self-transformation. Therefore, it is listed as an adjuvant together.

There are 18 herbs in the whole prescription, most of which are heat-clearing and damp-reducing products. According to the etiology, pathogenesis, and syndrome characteristics of cholelithiasis from different aspects, prescriptions and medicines can be formulated to clear heat and dampness, promote qi and blood stasis, and promote gallbladder and stone removal. It is suitable for damp-heat stagnation syndrome of cholelithiasis. Right upper quadrant pain (dull pain, distending pain, tingling pain), tenderness or paroxysmal, or even unbearable colic, painful shoulder and back, or high fever and chills, yellow sclera, yellow urine, constipation, red tongue, It can be taken by patients with dark red or ecchymosis, white or yellow greasy tongue coating, and rapid, slippery or thready pulse.

The contrast drug "Lidan Paishi Tablet" of the pharmacodynamic test of the present invention is composed of 250g of Desmodium, 250g of capillary, 75g of Scutellaria baicalensis, 75g of woody fragrance, 75g of turmeric, 125g of rhubarb, 125g of betel nut, and 50g of aurantium aurantium (stir-fried bran). , Glauber's salt (refined) 25g, magnolia officinalis (ginger) 50g composition. Compared with the present invention, Scutellaria baicalensis, turmeric, betel nut, and Glauber's salt are removed from the formula; gardenia, cork, cassia, pinellia, Cyperus cyperi, Rhizoma Chuanxiong, peach kernel, safflower, Moutan bark, hawthorn, and cassia twig are added to enhance liver soothing. Relieve depression, promote qi and relieve pain, promote blood circulation and remove blood stasis; adding raw sun-dried ginseng can invigorate qi and strengthen the body, so that the human body's ability to eliminate evil can be improved, which is more conducive to the improvement of clinical efficacy than simply clearing away heat and dampness, and promoting qi.

The most preferred prescription of the pharmaceutical composition of the present invention is composed of desmodium, gardenia, capillary, cortex, rhubarb, cassia, magnolia officinalis, Cyperus cyperi, Citrus aurantium, Pinellia fragrans, woody, Chuanxiong, Moutan cortex, hawthorn, peach kernel, red Made from flowers, raw sun-dried ginseng and osmanthus twigs. Desmodium in the prescription, sweet, bitter, slightly cold, belongs to the liver and gallbladder meridian, good at clearing liver and gallbladder damp heat, and is a commonly used medicine for clearing away heat and promoting gallbladder stones. , used with money grass to enhance the power of clearing away heat and dampness. Rhubarb relieves heat and clears blood stasis, cools blood and detoxifies, Magnolia officinalis dries dampness and blood stasis, promotes Qi, relieves nausea; , it is actually Xiaochengqi Decoction, which lightens heat knots and relieves pain; cassia seed assists rhubarb to clear away heat and laxative. Rhizoma Cyperi, Cyperi radixe, promoting Qi and relieving pain; Pinellia to dry dampness and harmonize the stomach; Magnolia officinalis, Rhizoma Rhizoma Cyperi, Pinellia Pinellia, Woody Fragrance, and Citrus aurantium are combined to strengthen the function of soothing the liver, relieving depression, promoting Qi and relieving pain. Ligusticum chuanxiong and safflower promote blood circulation and promote qi, dissipate blood stasis and relieve pain, peach kernel promote blood circulation and remove blood stasis, moisten intestines and laxative, peony bark clears heat and cools blood, removes stagnant heat in blood, promotes blood circulation and removes blood stasis, hawthorn eliminates food and harmonizes stomach, promotes blood circulation and stimulates menstrual flow. Combined use of the five medicines has a stronger effect of promoting blood circulation and removing blood stasis, and when combined with qi-promoting medicines such as magnolia officinalis, Cyperi cyperi, and woody incense, it can treat qi and blood at the same time. Raw sun-dried ginseng greatly invigorates vitality, nourishes the five internal organs, adjusts the middle coke, and is included in clearing heat and dampness, promoting qi and promoting blood circulation, which can prevent long-term use of heat-clearing and damp-removing medicines from depleting righteousness, and patients with cholelithiasis are often vulnerable to liver and gallbladder dampness and heat. Spleen and stomach, resulting in deficiency of spleen and stomach qi, ginseng can invigorate qi and strengthen the body, and improve the body's ability to eliminate evil. Guizhi is pungent, sweet and warm. The use of this prescription seems to be contrary to the damp-heat pathogenesis of cholelithiasis, but it is said in "The Classic of Shuzheng": "Guizhi can benefit the joints, warm the meridians and open the meridians." Cinnamomum twig anti-Zuo, taking its properties of dredging the meridians, is beneficial to play the role of clearing away heat, removing dampness, promoting qi and activating blood. All medicines are used in combination to play the functions of clearing heat and dampness, promoting qi and removing blood stasis, promoting gallbladder and removing stones. This prescription is unique and novel in conception. It mainly focuses on clearing away heat and dampness, and at the same time pays attention to promoting qi and relieving stagnation, promoting blood circulation and removing blood stasis. From different aspects, according to the etiology, pathogenesis, and syndrome characteristics of cholelithiasis, the formulation of prescriptions has achieved great success. Satisfactory curative effect.

In this clinical trial, the pharmaceutical composition granules of the present invention have a better effect on clinical symptoms and signs such as pain, anorexia, constipation, pantothenic acid, nausea, bitter mouth, dry throat, etc. good curative effect. Both gallbladder stone expulsion and gallbladder inflammation improvement showed good curative effect.

Detailed ways

Embodiment one

1. Phase II clinical research

Phase II clinical research approval number of the pharmaceutical composition of the present invention for the treatment of cholelithiasis complicated by chronic cholecystitis with damp-heat and qi-blood stasis syndrome: State Drug Administration No. 2001ZL250

Test center: Affiliated Hospital of Nanjing University of Traditional Chinese Medicine, Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, West China Hospital of Sichuan University (First Affiliated Hospital of West China University of Medical Sciences), Affiliated Hospital of Shaanxi Academy of Traditional Chinese Medicine

Purpose of the test: To evaluate the efficacy and safety of the pharmaceutical composition granules of the present invention in treating cholelithiasis complicated with chronic cholecystitis with damp-heat and qi-blood stasis syndrome

Experimental design: stratified block randomized, parallel controlled, double-blind, multi-center clinical trial

Subject population: in line with the diagnosis of gallstone disease combined with chronic cholecystitis and the syndrome differentiation of damp heat and qi and blood stasis in traditional Chinese medicine

Treatment scheme: the pharmaceutical composition granules of the present invention, orally, 1 bag each time, 3 times a day. The placebo of Lidan Paishi Tablets (that is, the blank tablet of Lidan Paishi Tablets), 8 tablets each time, once in the morning and evening.

Control group: the placebo of the pharmaceutical composition of the present invention (ie the blank granule of the pharmaceutical composition of the present invention) was taken orally, 1 bag each time, 3 times a day. Lidan Paishi Tablets, orally, 8 tablets each time, once in the morning and evening. The course of treatment is 8 weeks.

Main curative effect indicators: distension and pain in the right hypochondriac; stone and gallbladder condition (B-ultrasound)

Secondary efficacy indicators: anorexia, constipation, pantothenic acid, nausea, bitter mouth, dry throat, tongue pulse. Liver function tests (ALT, AST, ALP, r-GT, TBIL, DBIL); serum cholesterol.

Safety indicators: blood, urine, stool routine, electrocardiogram, liver function (ALT, AST), renal function (BUN, Scr)

Statistics: The comprehensive curative effect and the curative effect of gallstone disease expulsion (B-ultrasound) are respectively selected from the full analysis set and the protocol set analysis

According to the protocol set: 105 cases in the test group and 100 cases in the control group

Efficacy results: According to the protocol set, the recovery rate of B-ultrasound stone removal in the experimental group was 9.52%, and the total effective rate was 30.47%. The recovery rate of the control group was 4.00%, and the total effective rate was 22.00%. On the 42nd day of treatment, the disappearance rate of pain in the right hypochondriac was better than that in the control group.

According to the protocol set: the recovery rate of the test group was 77.14%, the total effective rate was 80.95%, and that of the control group were 66.00% and 70.00%.

The recovery rate of the test group is 75.42%, the total effective rate is 79.66%, and the control group is 60.53%, 65.04%.

2. Phase III clinical research

Phase III Clinical Study on the Treatment of Cholelithiasis Complicated by Chronic Cholecystitis with Damp-heat Syndrome of Qi and Blood Stasis with the Pharmaceutical Composition of the Present Invention

Approval number: State Drug Administration No. 2001ZL250

Test centers: Affiliated Hospital of Nanjing University of Traditional Chinese Medicine, Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, West China Hospital of Sichuan University (First Affiliated Hospital of West China University of Medical Sciences), Affiliated Hospital of Shaanxi Academy of Traditional Chinese Medicine, Nanjing General Hospital of Nanjing Military Command, Changzhou Hospital of Traditional Chinese Medicine

Test start and end date: May 06, 2003 to May 13, 2004

Purpose of the test: To evaluate the efficacy and safety of the pharmaceutical composition granules of the present invention in the treatment of cholelithiasis complicated with chronic cholecystitis with damp-heat and qi-blood stasis syndrome

Experimental design: stratified block randomized, parallel controlled, double-blind, multi-center clinical trial

Subject population: in line with the diagnosis of gallstone disease combined with chronic cholecystitis and the syndrome differentiation of damp heat and qi and blood stasis in traditional Chinese medicine

Treatment scheme: test group: the pharmaceutical composition granules of the present invention, orally, 1 bag each time, 3 times a day. The placebo of Lidan Paishi Tablets (that is, the blank tablet of Lidan Paishi Tablets), 8 tablets each time, once in the morning and evening.

Control group: the placebo of the pharmaceutical composition of the present invention (ie the blank granules of the pharmaceutical composition of the present invention), orally, 1 bag each time, 3 times a day. Lidan Paishi Tablets, orally, 8 tablets each time, once in the morning and evening.

Continuous medication for 8 weeks is a course of treatment, and a follow-up visit is performed every 2 weeks. The observation time is 1 course of treatment. After the end of the clinical trial, the patients were treated according to the current clinical practice.

Main curative effect indicators: disappearance rate of right hypochondriac distension and pain, stone expulsion rate.

Secondary efficacy indicators: stones and gallbladder; symptoms and signs; liver function test

Safety indicators: blood, urine, stool routine, electrocardiogram, liver and kidney function

Statistics: The disappearance rate of right hypochondriac pain disappearance rate, stone expulsion rate, and comprehensive curative effect were analyzed using the data of the full analysis set and the protocol set respectively

According to the protocol set: 313 cases in the experimental group and 99 cases in the control group

Curative effect results: the pharmaceutical composition of the present invention has good curative effect on pain, anorexia, constipation, pantothenic acid, nausea and other clinical symptoms and signs in the treatment of cholelithiasis complicated with chronic cholecystitis with damp-heat and qi and blood stasis syndrome. Both gallbladder stone expulsion and gallbladder inflammation improvement showed good curative effect.

The medicinal composition of the invention is effective and safe for treating cholelithiasis complicated with chronic cholecystitis with damp-heat and qi-blood stasis syndrome. Main efficacy indicators: the number of pain attacks and the degree of pain in the treatment group were better than those in the control group.

According to the plan set: the cure rate of B-ultrasound stone removal treatment group was 12.46%, the total effectiveness was 37.70%, and the control group was 4.04% and 19.19%. Full analysis set: B-ultrasound calculus removal curative effect treatment group had a cure rate of 12.12%, and the total effectiveness was 36.67%, while that of the control group was 4.63% and 19.44%. The curative effect, recovery rate and total effectiveness of B-ultrasound stone removal are all better in the treatment group than in the control group.

Secondary curative effect index: The curative effect of anorexia, constipation, pantothenic acid, nausea, bitter mouth and dry throat in the treatment group was better than that in the control group.

The curative effect of gallbladder wall and bile sound transmission after gallbladder B-ultrasound examination was better in the treatment group than in the control group.

According to the plan set: the cure rate of the treatment group was 76.68%, the total effectiveness was 77.32%, and the control group was 44.44% and 45.45%, respectively. The 95% CI (16.39, 47.34) of the difference in the total effective rate. Full analysis set: the cure rate of the treatment group was 73.86%, the total effectiveness was 74.43%, and the control group was 46.49% and 47.37%, respectively. The 95% CI (12.74, 41.39) of the difference in the total effective rate. Symptom comprehensive curative effect, recovery rate, and total effectiveness are all better in the treatment group than in the control group.

In order to exclude center differences, the comprehensive curative effect, recovery rate and total effectiveness of the two groups stratified by center were superior to those in the control group. In the treatment group, 3 cases were grade 3 in safety evaluation, and 2 cases were grade 4 in safety evaluation. The difference in safety evaluation between the two groups was not statistically significant.

Embodiment two

The raw medicinal materials used in the pharmaceutical composition of the present invention are all pharmacopoeia varieties, and all are commercially available decoction pieces.

Prescription: Desmodium 5 grams, Gardenia 2.5 grams, Phellodendron 1.7 grams, Cassia 2 grams, Rhizoma Chuanxiong 1.7 grams, Magnolia officinalis 2 grams, Cortex Moutan 1.7 grams, Sun-dried ginseng 1 gram, Guizhi 1.7 grams, Capillaris 2.5 grams, 1 gram of rhubarb, 1.7 grams of French pinellia, 2.5 grams of hawthorn, 1.7 grams of peach kernel, 1 gram of safflower, 2.5 grams of Cyperus cypress, 1.7 grams of citrus aurantium, and 1.7 grams of woody fragrance.

1. Take the prescribed amount of magnolia officinalis, rhubarb, cassia seed, raw sun-dried ginseng, and Pinellia five flavors and grind them into coarse powder, use 60% ethanol as solvent, soak for 24 hours, percolate, collect 6 times the amount at a collection speed of 3ml/min (Based on the weight of medicinal materials), recover ethanol to form an extract, with a relative density of about 1.20 (50°C).

2. Take the prescribed amount of Cortex Moutan and pulverize it into coarse powder, steam distill it, collect 10 times the amount (by weight of the medicinal material) of the distillate, and collect the distilled aqueous solution in another device. Refrigerate the distillate overnight, filter to obtain paeonol crystals, use β-CD for inclusion, dry the inclusion, and pulverize into fine powder to obtain inclusion A, which is set aside.

3. Take the prescribed amount of Muxiang, Rhizoma Cyperi, Fructus Citrus Fructus Citrus Citrifolia, Guizhi, and Ligusticum Chuanxiong, and grind them into coarse powder, soak them with Desmodium Chrysanthemum and Yinchen for 2 hours, add 7 times the amount (that is, 7 times the weight of the medicinal materials) of water, and extract the volatile oil 4 hours. The aqueous solution after extracting the volatile oil was collected in another device. The volatile oil was clad with β-CD, and the clathrate was dried and pulverized into a fine powder to obtain clathrate B, which was set aside.

4. In step 3, decoct the medicinal dregs after extracting the volatile oil and the medicinal dregs of Moutan Cortex with gardenia, cork, peach kernel, safflower, and hawthorn in water for 2 hours each time. The aqueous solutions after phenol were combined, filtered, and the filtrate was concentrated to a relative density of about 1.15 (50°C), adding ethanol to adjust the alcohol content to 60%, and standing for 24 hours, pouring the supernatant to recover the ethanol and concentrating to a relative density of about 1.10 (50 ℃) clear ointment, dry, get fine powder C, set aside.

5. Take fine powder C, add appropriate amount of dextrin, appropriate amount of sweetener, use the alcohol extraction extract in step 1 to granulate, dry, add inclusions A and inclusions B, mix evenly, make granules, and pack into bags. Three times a day, 1 bag each time/equivalent to 46.9 grams of crude drug.

Embodiment three

Prescription: 5 grams of Desmodium, 2.5 grams of Gardenia, 1.5 grams of Cortex Phellodendri, 2 grams of Semen Cassiae, 1.5 grams of Chuanxiong, 2 grams of Magnolia officinalis, 1.5 grams of Moutan Cortex, 1 gram of Sun-dried Ginseng, and 1.5 grams of Guizhi.

1. Extract the Semen Cassiae, Magnolia Magnolia officinalis, and Sun-dried Ginseng containing 80% ethanol as a solvent, and after concentration, obtain an extract of the alcohol extract, with a relative density of about 1.10 (50° C.);

2. Steam distill the Cortex Moutan of the described weight ratio, collect 7 times the amount (by medicinal material weight) distillate, refrigerate overnight, filter to obtain paeonol crystals; paeonol crystals add appropriate amount of ethanol after dissolving , use β-CD for inclusion, dry the inclusion, and pulverize into fine powder to obtain inclusion A, which is set aside.

3. Extract the volatile oil from the cassia twigs, chuanxiong and Desmodium in the weight ratio; the aqueous solution after extracting the volatile oil is collected in another device; the volatile oil is clad with β-CD, and the clathrate is dried and pulverized into fine powder to obtain clathrate Object B, spare.

4. Merge the dregs after extracting the volatile oil, the dregs of Moutan Cortex with Gardenia and Cortex Phellodendri, extract with water to obtain a water extract; combine the water extract and the aqueous solution after extracting the volatile oil, concentrate, add ethanol, and adjust the alcohol content reach 60%, stand still, take the supernatant, recover ethanol, concentrate to obtain a clear paste, dry to obtain a fine powder C, and set aside.

5. The granulation method is the same as step 5 of Example 2 (without adding sweetener), filling capsules and packing.

Embodiment Four

Prescription: 10 grams of Desmodium, 5 grams of Gardenia, 3 grams of Cortex Phellodendri, 4 grams of Cassia, 3 grams of Rhizoma Chuanxiong, 4 grams of Magnolia officinalis, 3 grams of Moutan Cortex, 2 grams of Sun-dried Ginseng, 3 grams of Guizhi, 5 grams of Yin Chen, 2 grams of rhubarb, 3 grams of French pinellia, 5 grams of hawthorn, 3 grams of peach kernel, 2 grams of safflower, 5 grams of Cyperus cypress, 3 grams of Citrus aurantium, and 3 grams of woody fragrance.

1, magnolia officinale, rhubarb, Semen Cassiae, sun-dried ginseng, and Pinellia five flavors of the described weight ratio are pulverized into coarse powder, and 5% ethanol is used as solvent, soaked for 24 hours, percolated, and the collection speed is 3ml/min. Collect 10 times the amount (according to the weight of medicinal materials), and recover ethanol to form an extract with a relative density of about 1.10 (50°C).

2, the Cortex Moutan of described weight ratio is pulverized into coarse powder, steam distillation, collects 7 times of amount (by medical material weight) distillate, and the aqueous solution after distillation is collected in another device. Refrigerate the distillate overnight, filter to obtain paeonol crystals, add appropriate amount of ethanol to dissolve, use β-CD for inclusion, dry the inclusion, and crush it into fine powder to obtain inclusion A, which is set aside.

3. Grind the woody, Cyperus cyperi, Fructus Citrus Fructus Citrus Fructus Citrii Fructus, Cinnamomum twig, and Rhizoma Chuanxiong of the described weight ratio into coarse powder, soak with Desmodium Desmodium and Capillary wormwood for 2 hours, add 7 times the amount (that is, 7 times the weight of the medicinal material) water, to extract the volatile oil for 4 hours. The aqueous solution after extracting the volatile oil was collected in another device. The volatile oil was clad with β-CD, and the clathrate was dried and pulverized into a fine powder to obtain clathrate B, which was set aside.

4. The dregs after extracting volatile oil and the dregs of Moutan cortex are decocted with gardenia, cork, peach kernel, safflower, and hawthorn twice, each time for 2 hours, and the decoction, the aqueous solution after extracting volatile oil and paeonol Merge, filter, concentrate the filtrate to a relative density of about 1.10 (50°C), add ethanol, adjust the alcohol content to 70%, let it stand for 24 hours, pour the supernatant to recover the ethanol and concentrate to a relative density of about 1.10 (50°C ), add 20% dextrin by weight of the clear paste, fully stir, and spray dry to obtain fine powder C for subsequent use.

5. The granulation method is the same as that in step 5 of Example 2 (without adding sweetener), and an appropriate amount of granules are made, tableted, and packaged.

Embodiment five

Prescription: Desmodium 5 grams, Gardenia 2.5 grams, Phellodendron 1.5 grams, Cassia 2 grams, Rhizoma Chuanxiong 1.5 grams, Magnolia officinalis 2 grams, Moutan bark 1.5 grams, Sun-dried ginseng 1 gram, Guizhi 1.5 grams, Capillaris 2.5 grams, 1 gram of rhubarb, 1.5 grams of French pinellia, 2.5 grams of hawthorn, 1.5 grams of peach kernel, 1 gram of safflower, 2.5 grams of Cyperus cypress, 1.5 grams of Citrus aurantium, and 1.5 grams of woody fragrance.

1. Grind the cortex of peony, woody incense, Cyperus cyperi, Citrus aurantium, cinnamon twig, and Chuanxiong into coarse powder, soak it with Desmodium syringae and Capillary wormwood for 2 hours, add 7 times the amount (that is, 7 times the weight of the medicinal materials) Water, collect the distillate of 3 times the weight of the medicinal material, and set aside.

2. Extract the dregs of the volatile oil and the prescribed amount of magnolia officinalis, rhubarb, cassia, sun-dried ginseng, pinellia, five flavors, gardenia, phellodendron, peach kernel, safflower, and hawthorn, and decoct twice, each time for 2 hours , combined the decoction, filtered, the filtrate was concentrated to a relative density of about 1.15 (50°C), added ethanol, and the alcohol content reached 60%, stood for 24 hours, poured the supernatant to recover the ethanol and concentrated to a relative density of about 1.15 (50°C) extract, set aside.

3. Take the extract in step 2 and the distillate in step 1, add an appropriate amount of simple syrup, stir evenly, and make a syrup. Fill it and serve.

Embodiment six

Prescription: Desmodium 5 grams, Gardenia 2.5 grams, Phellodendron 1.7 grams, Cassia 2 grams, Rhizoma Chuanxiong 1.7 grams, Magnolia officinalis 2 grams, Cortex Moutan 1.7 grams, Sun-dried ginseng 1 gram, Guizhi 1.7 grams, Capillaris 2.5 grams, 1 gram of rhubarb, 1.7 grams of French pinellia, 2.5 grams of hawthorn, 1.7 grams of peach kernel, 1 gram of safflower, 2.5 grams of Cyperus cypress, 1.7 grams of citrus aurantium, and 1.7 grams of woody fragrance.

1. Grind the cortex of peony, woody incense, Cyperus cyperi, Citrus aurantium, cinnamon twig, and Chuanxiong into coarse powder, soak it with Desmodium syringae and Capillary wormwood for 2 hours, add 7 times the amount (that is, 7 times the weight of the medicinal materials) Water, collect the distillate of 3 times the weight of the medicinal material, and set aside.

2. Extract the dregs of the volatile oil and the prescribed amount of magnolia officinalis, rhubarb, cassia, sun-dried ginseng, pinellia, five flavors, gardenia, phellodendron, peach kernel, safflower, and hawthorn, and decoct twice, each time for 2 hours , combined the decoction, filtered, the filtrate was concentrated to a relative density of about 1.15 (50°C), added ethanol, and the alcohol content reached 60%, stood for 24 hours, poured the supernatant to recover the ethanol and concentrated to a relative density of about 1.15 (50°C) extract, set aside.

3. Take the extract in the above step 2 and the distillate in step 1, add an appropriate amount of sweetener, add an appropriate amount of distilled water, stir evenly, and make a mixture. Fill it and serve.

Embodiment seven

Prescription: Desmodium 5 grams, Gardenia 2.5 grams, Phellodendron 1.5 grams, Cassia 2 grams, Chuanxiong 1.5 grams.

Soak Rhizoma Chuanxiong and Desmodium in water for 2 hours, add 7 times the amount (7 times the weight of the medicinal materials) of water, and extract the volatile oil; the aqueous solution after extracting the volatile oil is collected in another device; the volatile oil is wrapped with β-cyclodextrin, Dried volatile oil inclusion complex B, set aside;

Combine the dregs after extracting the volatile oil with the prescribed amount of gardenia, Phellodendron phellodendron, and Semen Cassiae, and extract with water to obtain a water extract; combine the water extract and the aqueous solution after extracting the volatile oil, concentrate to a relative density of about 1.15 (50°C), add Ethanol, adjust the alcohol content to 50%, let it stand still for 24 hours, take the supernatant, recover the ethanol, concentrate, dry, and obtain the medicinal powder; take the medicinal powder and mix the volatile oil complex B, and pack into capsules.

Claims (10)

1. A pharmaceutical composition for treating gallbladder disease, characterized in that it is mainly made of the following raw materials in parts by weight: Desmodium 5-10 parts Gardenia 2.5-5 parts Phellodendron 1.5-3 parts Cassia 2-4 parts Rhizoma Chuanxiong 1.5-3 servings. 2. The preparation method of the pharmaceutical composition of claim 1, comprising the following steps: 1) Weighing raw materials Desmodium, Gardenia; Phellodendron Cortex, Semen Cassiae, Rhizoma Chuanxiong, set aside; 2) extract the volatile oil from Rhizoma Chuanxiong and Desmodium in the weight ratio; the volatile oil is clathrated with β-cyclodextrin, and the volatile oil clathrate B is dried for subsequent use; 3) Merge the dregs after extracting the volatile oil with gardenia, phellodendron, and cassia seeds, extract with water to obtain a water extract; concentrate the water extract, add ethanol, let stand, take the supernatant, reclaim ethanol, and concentrate the extract , mixed with the volatile oil inclusion complex B of 2), to obtain the active ingredient of the medicament of the present invention. 3. The pharmaceutical composition as claimed in claim 1, wherein the raw materials include: Magnolia officinalis 2-4 parts, Cortex Moutan 1.5-3 parts, Sun-dried Ginseng 1-2 parts, Guizhi 1.5-3 parts. 4. The preparation method of the pharmaceutical composition according to claim 3, comprising the following steps: 1) Weigh the raw materials Desmodium chinensis, gardenia, Cortex Phellodendri, Semen Cassiae, Rhizoma Chuanxiong, Magnolia Officinalis, Cortex Moutan, Sun-dried Ginseng, Guizhi, and set aside; 2) Distilling the Cortex Moutan in the weight ratio to obtain paeonol crystals; the paeonol crystals are clad with β-cyclodextrin to obtain inclusion A, which is set aside; the paeonol crystals in the weight ratio Extract volatile oil from Guizhi, Chuanxiong and Desmodium; volatile oil is encapsulated with β-cyclodextrin to obtain inclusion B, which is set aside; 3) Alternatively, mix Moutan Cortex, Guizhi, Chuanxiong, Desmodium, and Yinchen for steam distillation, collect the distillate D, and set aside; 4) Merge the dregs of extracted volatile oil with gardenia, Phellodendron cork, Semen Cassiae, Magnolia officinalis, and Sun-dried Ginseng, and extract with water to obtain a water extract; concentrate the water extract, add ethanol, let it stand, and take the supernatant, Recover ethanol and concentrate to obtain the extract of water extract; 5) Mix the extract extract of 4) with the inclusion complex A and inclusion complex B of 2) to obtain the active component of the medicine of the present invention; or, mix the extract extract of 4) with the distillate D of 3) , to obtain the active ingredient of the medicament of the present invention. 5. The pharmaceutical composition according to claim 3, wherein the raw materials also include: 2.5-5 parts of capillary, 1-2 parts of rhubarb, 1.5-3 parts of Pinellia chinensis, 2.5-5 parts of hawthorn, 1.5-3 parts of peach kernel, red 1-2 parts of flowers, and one or more mixtures selected from 2.5-5 parts of Cyperus cyperi, 1.5-3 parts of Citrus aurantium and 1.5-3 parts of woody fragrance. 6. The pharmaceutical composition according to claim 5, wherein the dosage of the raw material is: 5-10 parts of Desmodium, 2.5-5 parts of Gardenia, 1.5-3 parts of Cortex Phellodendri, 2-4 parts of Semen Cassiae, 1.5-3 parts of Chuanxiong, thick 2-4 parts of pomegranate, 1.5-3 parts of Moutan bark, 1-2 parts of raw sun-dried ginseng, 1.5-3 parts of cassia twig, 2.5-5 parts of capillary, 1-2 parts of rhubarb, 1.5-3 parts of Pinellia chinensis, hawthorn 2.5-5 parts, 1.5-3 parts of peach kernel, 1-2 parts of safflower, 2.5-5 parts of Cyperus cyperi, 1.5-3 parts of Citrus aurantium, 1.5-3 parts of woody fragrance. 7. The pharmaceutical composition according to claim 6, wherein the dosage of the raw material is: 5 parts of Desmodium, 2.5 parts of Gardenia, 1.7 parts of Cortex Phellodendri, 2 parts of Semen Cassiae, 1.7 parts of Rhizoma Chuanxiong, 2 parts of Magnolia officinalis, 1.7 parts of Cortex Moutan, raw 1 part of sun-dried ginseng, 1.7 parts of cassia twig, 2.5 parts of capillary, 1 part of rhubarb, 1.7 parts of pinellia, 2.5 parts of hawthorn, 1.7 parts of peach kernel, 1 part of safflower, 2.5 parts of Cyperus cyperi, 1.7 parts of aurantium, woody 1.7 servings. 8. The preparation method of the pharmaceutical composition according to any one of claims 5-7, comprising the following steps: 1) Weigh the raw materials Desmodium, Gardenia, Phellodendron, Cassia, Rhizoma Chuanxiong, Magnolia officinalis, Cortex Moutan, Sun-dried Ginseng, Guizhi, Yinchen, Rhubarb, Pinellia, Peach Kernel, Safflower, Hawthorn, Cyperus Cyperi, Citrus aurantium or/and woody fragrance, spare; 2) extracting the Semen Cassiae, Magnolia officinalis officinale, Sun-dried Ginseng, Rhubarb and Pinellia chinensis in the weight ratio with ethanol containing 5-80% as a solvent, and concentrated to obtain the extract of the alcohol extract; 3) Distilling the Cortex Moutan in the weight ratio to obtain paeonol crystals; the paeonol crystals are clad with β-cyclodextrin to obtain inclusion A, which is set aside; the paeonol crystals in the weight ratio are Extract volatile oil from capillary, cinnamon twig, chuanxiong and Desmodium, and one or more raw materials selected from Muxiang, Rhizoma Cyperi and Aurantium citrus; the volatile oil is encapsulated with β-cyclodextrin to obtain inclusion B ,spare; 4) Alternatively, mix Moutan bark, woody incense, Cyperus cyperi, Citrus aurantium, Guizhi, Chuanxiong, Desmodium, and capillary for steam distillation, and collect the distillate D for later use; 5) Combine gardenia, cork, peach kernel, safflower and hawthorn, extract with water to obtain a water extract; concentrate the water extract, add ethanol, adjust the alcohol content to 50-80%, let stand, take the supernatant, Recover ethanol and concentrate to obtain water extract extract; 6) Mix the water extract extract of 5), the alcohol extract extract of 2), and the inclusion complex A and inclusion complex B of 3) to obtain the active component of the medicament of the present invention; Or, take 5) water extract extract and 2) alcohol extract extract and 4) distillate D and mix to obtain the active component of the medicine of the present invention. 9. The preparation method of the pharmaceutical composition according to claim 8, wherein Extract the cassia seed, magnolia officinale, sun-dried ginseng, rhubarb and pinellia with 50-60% ethanol as solvent, concentrate to 50°C relative density of 1.10-1.20, and obtain the alcohol extract extract ; Distilling the Cortex Moutan in the weight ratio to obtain paeonol crystals; the paeonol crystals are clad with β-cyclodextrin, and the paeonol crystals are clathrated with β-cyclodextrin, and clathrate A is dried for later use; The volatile oil is extracted from capillary, osmanthus twig, chuanxiong and desmodium in the weight ratio, and one or more raw materials selected from woody, Cyperus and Citrus aurantii; the volatile oil is wrapped with β-cyclodextrin Knot, dry volatile oil clathrate B, set aside; Extract gardenia, cork, peach kernel, safflower and hawthorn with water to obtain water extract; concentrate the water extract into an extract with a relative density of 1.10-1.20 at 50°C, add ethanol to adjust the alcohol content to 55-70% and let stand , take the supernatant, recover ethanol, concentrate to 50 ° C relative density 1.10-1.20, add the extract of alcohol extract, mix, dry, and obtain medicinal powder; take medicinal powder and mix inclusion substance A and inclusion substance B to obtain The active ingredient of the medicament of the present invention; the active ingredient of the medicament of the present invention is mixed with a pharmaceutically acceptable auxiliary material. 10. The preparation method of the pharmaceutical composition of claim 9, wherein The weight ratio Magnolia officinalis officinale, rhubarb, Semen Cassiae, raw sun-dried ginseng, and Pinellia chinensis were soaked for 24 hours with 60% ethanol, percolated, and the collection speed was 3ml/min, and 10 times the amount of ethanol percolated liquid was collected, and the ethanol was reclaimed to Extract with a relative density of about 1.15 at 50°C; steam distill Moutan cortex, collect 7 times the distillate, and collect the distilled aqueous solution in another container; refrigerate the distillate overnight, filter to obtain paeonol crystals, add appropriate amount of ethanol to dissolve Finally, use β-cyclodextrin for inclusion, dry the inclusion, crush it into fine powder A, and set aside; extract the volatile oil of Muxiang, Rhizoma Cyperi, Fructus Citrus Fructus Citrus Fructus Citrus Fructus Aurantii, Guizhi, Ligusticum Chuanxiong, Desmodium Chrysanthemum, and Capillaris. The aqueous solution after the volatile oil is collected in another device, the volatile oil is included with β-cyclodextrin, the inclusion is dried, pulverized into fine powder B, and set aside; the medicinal residues after extracting the volatile oil and the medicinal residues of Moutan Cortex are mixed with gardenia, Phellodendron, Decoct peach kernels, safflower, and hawthorn twice with water, 2 hours each time, combine the decoction, the aqueous solution after extracting volatile oil and paeonol, filter, concentrate the filtrate to a relative density of about 1.15 at 50°C, add ethanol, and adjust the content The amount of alcohol reaches 60%, let it stand for 24 hours, pour the supernatant to reclaim the ethanol and concentrate it to a relative density of about 1.15 at 50°C, add the alcohol extraction extract, mix, and dry to obtain the active component of the medicine of the present invention; The active components of the medicine are mixed with pharmaceutically acceptable auxiliary materials to make granules or capsules, tablets, mixtures, and syrups.