CN113116976A

CN113116976A - Application of traditional Chinese medicine composition in preparation of medicine for preventing or treating digestive internal diseases

Info

Publication number: CN113116976A
Application number: CN202110613070.4A
Authority: CN
Inventors: 张贵民; 李蔚群; 郝大伟
Original assignee: Lunan Pharmaceutical Group Corp
Current assignee: Lunan Pharmaceutical Group Corp
Priority date: 2021-03-20
Filing date: 2021-06-02
Publication date: 2021-07-16

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly discloses application of a traditional Chinese medicine composition in preparation of a medicine for preventing or treating digestive system diseases. The traditional Chinese medicine composition is prepared from 11 raw medicinal materials of schizonepeta, divaricate saposhnikovia root, incised notopterygium rhizome, doubleteeth pubescent angilica root, Chinese thorowax root, whiteflower hogfennel root, Szechuan lovage rhizome, bitter orange, Indian buead, platycodon root and liquoric root, and the invention is a new application of developing a product Jingfang preparation on. Pharmacological experiments show that the traditional Chinese medicine composition can effectively reduce the activity of serum amylase and serum lipase, relieve inflammatory reaction, reduce the release level of inflammatory cytokines TNF-alpha and IL-6 in serum, enhance the activity of SOD in pancreatic tissues, reduce the content of MDA in the tissues, treat both symptoms and root causes, and has exact treatment effect on pancreatitis.

Description

Application of traditional Chinese medicine composition in preparation of medicine for preventing or treating digestive internal diseases

Technical Field

The invention relates to a new application of a traditional Chinese medicine composition, in particular to an application of the traditional Chinese medicine composition in preparing a medicine for preventing or treating digestive internal diseases, and belongs to the technical field of traditional Chinese medicines.

Background

The department of gastroenterology is a medical discipline for researching diseases of esophagus, stomach, small intestine, large intestine, liver, gallbladder and pancreas, and the like, and the diseases of the department of gastroenterology mainly comprise gastrointestinal diseases, liver diseases, biliary diseases, pancreatic diseases, peritoneal and mesenteric diseases and the like, wherein the pancreatic diseases comprise pancreatic congenital diseases, pancreatic injury diseases, pancreatic inflammatory diseases, pancreatic cystic lesions and pancreatic secretory tumors.

Pancreatitis (pancreatitis) is a disease of pancreas caused by the self-digestion of trypsin, and the pancreas has edema, hyperemia, hemorrhage, necrosis, and high amylase content in laboratory blood and urine. Pancreatitis is classified into acute pancreatitis and chronic pancreatitis, and its clinical manifestations include abdominal pain, abdominal distention, nausea, emesis, fever, etc. Pancreatitis is caused by multiple reasons, wherein acute pancreatitis is caused by biliary tract diseases, alcoholism, binge drinking and eating, operation and injury, infection, hyperlipidemia, hypercalcemia and the like; chronic pancreatitis is a disease of chronic progressive destruction of the pancreas caused by repeated attacks of acute pancreatitis. Pancreatitis is a common pancreatic disease, wherein Acute Pancreatitis (AP) is a common clinical acute abdomen, the mortality rate is 5% -10%, and 20% -30% of patients can develop Severe Acute Pancreatitis (SAP). SAP often secondary infection, peritonitis, shock, etc. many complications, the fatality rate is up to 36% -50%, therefore acute pancreatitis has the onset urgent, progress fast, complication many, disease incidence and disease fatality rate high grade characteristic; the most common complications of chronic pancreatitis are pseudocyst formation and mechanical obstruction of the duodenum, common channel, and are associated with the development of pancreatic cancer.

In the prior art, most pancreatitis treatment adopts operation or chemical treatment, wherein the operation treatment easily causes secondary damage to patients, and the treatment cost is expensive and is not easy to be accepted by the patients; the chemical medicine treatment generally mainly uses antibiotics and hormones, but can only relieve symptoms in a short time, treats symptoms but not root causes, has low cure rate and more adverse reactions and side effects, and seriously influences the life quality of patients. Traditional Chinese medicine has unique insights on the onset and treatment of pancreatitis. In recent years, with the further development of the traditional Chinese medicine and the continuous and deep research on the curative effect mechanism of pancreatitis, the traditional Chinese medicine is combined and applied to treat pancreatitis on the basis of the conventional treatment of western medicine, so that the curative effect can be obviously improved, the state of an illness can be relieved, and the occurrence of complications can be reduced. Pancreatitis belongs to the categories of epigastric pain, abdominal pain, splenic cardialgia, pancreas heat and the like in traditional Chinese medicine, causes of the pancreatitis comprise exogenous pathogenic factors invasion, drinking, overeating, ascaris internal disturbance, emotional disorder, biliary tract stone resistance and the like, and the treatment of pancreatitis takes the treatment principles of clearing internal organs and discharging turbidity, clearing heat and removing toxicity, activating blood circulation to dissipate blood stasis, promoting qi circulation and relieving pain.

The Jingfang preparation is derived from ancient prescription Jingfang toxin-vanquishing powder, is prepared from eleven raw material medicines of schizonepeta, divaricate saposhnikovia root, incised notopterygium rhizome, doubleteeth pubescent angelica root, Chinese thorowax root, whiteflower hogfennel root, Szechuan lovage rhizome, bitter orange, Indian buead, platycodon root, liquoric root and the like, has the effects of inducing sweat, relieving exterior syndrome, dispelling wind and eliminating dampness, and is clinically used for treating symptoms of wind-cold type cold, headache. In recent years, with the deep development of the research of the traditional Chinese medicine preparation, more and more effects of the Jingfang preparation are discovered.

Disclosure of Invention

The invention aims to provide the application of the traditional Chinese medicine composition in preparing medicines for preventing or treating digestive internal diseases, particularly pancreatitis, and increase the medication selectivity of patients. The invention is further developed by a new application based on the clinical use feedback of the existing Chinese patent medicine product 'Jingfang preparation', namely the new application of the Jingfang preparation in treating digestive system diseases.

The invention aims to solve the technical problem of providing an application of a traditional Chinese medicine composition in preparing a medicine for preventing or treating digestive internal diseases, wherein the traditional Chinese medicine composition is prepared from schizonepeta, divaricate saposhnikovia root, notopterygium root, radix angelicae pubescentis, radix bupleuri, radix peucedani, ligusticum wallichii, fructus aurantii, poria cocos, platycodon grandiflorum and liquorice.

The digestive medical diseases described in the present invention include, but are not limited to, pancreatitis.

Preferably, the pancreatitis is acute pancreatitis or chronic pancreatitis.

The pancreatitis of the invention includes but is not limited to pancreatitis caused by virus infection, alcoholism, biliary tract disease and metabolic disorder.

Preferably, said pancreatitis is viral pancreatitis.

The traditional Chinese medicine composition is prepared from the following traditional Chinese medicine components:

preferably, the traditional Chinese medicine composition is prepared from the following traditional Chinese medicine components:

the traditional Chinese medicine composition is an oral medicine preparation, and preferably, the oral medicine preparation is one of granules, tablets, capsules, oral liquid, mixture, syrup or microcapsules.

The preparation method of the oral pharmaceutical preparation comprises the following steps:

A. extracting volatile oil from 7 medicinal materials of schizonepeta, divaricate saposhnikovia root, incised notopterygium rhizome, doubleteeth pubescent angilica root, whiteflower hogfennel root, szechuan lovage rhizome and bitter orange respectively to obtain the volatile oil of the 7 medicinal materials respectively, and distilling the residue, the szechuan lovage rhizome and the bitter orange to obtain aqueous solution for later use;

B. b, adding the volatile oil obtained in the step A into beta-cyclodextrin respectively to prepare an inclusion compound;

C. b, preparing the water solution of the distilled rhizoma ligustici wallichii and the fructus aurantii obtained in the step A into a 20-30% ethanol solution as a solvent, and percolating the residues of the rhizoma ligustici wallichii and the fructus aurantii obtained in the step A and the poria cocos to obtain percolate for later use;

D. decocting the residues of the schizonepeta, the divaricate saposhnikovia root, the incised notopterygium rhizome, the doubleteeth pubescent angilica root and the whiteflower hogfennel root obtained in the step A and the rest three medicines of the Chinese thorowax root, the platycodon root and the liquoric root in water for 1 to 3 times, wherein each time of the decoction is 1 to 3 hours, filtering the decoction, and concentrating the filtrate to an extract with the relative density of 1.18 to 1;

E. mixing the percolate obtained in the step C and the extract obtained in the step D, uniformly mixing, standing, filtering, and concentrating the filtrate to obtain an extract with the relative density of 1.22-1.28 at 50-60 ℃;

F. and D, taking the extract obtained in the step E and the beta-cyclodextrin inclusion compound obtained in the step B, and preparing an oral medicinal preparation directly or by adding a pharmaceutically acceptable excipient through a conventional process.

In one embodiment, the Jingfang preparation is Jingfang granules, and the preparation method comprises the following steps:

C. b, preparing a 25% ethanol solution of the distilled water solution of the ligusticum wallichii and the fructus aurantii obtained in the step A as a solvent, and percolating the residues of the ligusticum wallichii and the fructus aurantii obtained in the step A and the poria cocos to obtain a percolate for later use;

D. decocting the residues of the schizonepeta, the divaricate saposhnikovia root, the incised notopterygium rhizome, the doubleteeth pubescent angilica root and the whiteflower hogfennel root obtained in the step A and the rest three medicines of the Chinese thorowax root, the platycodon root and the liquoric root in water for 3 times, 2 hours for each time, combining decoction, filtering, and concentrating the filtrate to an extract with the relative density of 1.23 at the;

E. c, combining the percolated liquid obtained in the step C and the extract obtained in the step D, uniformly mixing, standing, filtering, and concentrating the filtrate to an extract with the relative density of 1.26 at 50-60 ℃;

F. and E, belt-type vacuum drying the extract obtained in the step E under the conditions of vacuum degree of-0.08 MPa to-0.10 MPa and drying temperature of 63 ℃, crushing the extract into fine powder, sieving the fine powder, adding the beta-cyclodextrin inclusion compound obtained in the step B, and uniformly mixing the fine powder to obtain the Jingfang extract fine powder, wherein the weight ratio of the extract to the sucrose powder in the formula is as follows: hydroxypropyl starch: mannitol 3: 2: 0.5 excipient, mixing, granulating, drying, and grading.

In another embodiment, the Jingfang preparation is a Jingfang mixture, and the preparation method comprises the following steps:

A. extracting volatile oil from 7 medicinal materials of schizonepeta, divaricate saposhnikovia root, incised notopterygium rhizome, doubleteeth pubescent angilica root, whiteflower hogfennel root, szechuan lovage rhizome and bitter orange respectively, and collecting the distilled aqueous solution in another container;

B. b, preparing a 25% ethanol solution of the distilled water solution of the ligusticum wallichii and the fructus aurantii obtained in the step A as a solvent, and percolating the residues of the ligusticum wallichii and the fructus aurantii obtained in the step A and the poria cocos to obtain a percolate for later use;

C. decocting the rest 5 kinds of residues with bupleuri radix, radix Platycodi, Glycyrrhrizae radix and water for three times, filtering, mixing filtrates, concentrating, mixing with the filtrate, standing, filtering, concentrating, adding appropriate amount of sodium benzoate and the volatile oil obtained in step A, stirring, and adding water to obtain mixture.

Compared with the prior art, the invention has the following remarkable technical effects:

the traditional Chinese medicine composition can effectively reduce the activity of serum amylase and serum lipase, relieve inflammatory reaction, reduce the release level of inflammatory cytokines TNF-alpha and IL-6 in serum, enhance the activity of SOD in pancreatic tissues, reduce the content of MDA in the tissues and have a certain treatment effect on acute pancreatitis.

The inventors note that the use of the invention is derived from clinical use feedback of Jingfang preparations. Currently, Jingfang preparations are marketed as Jingfang granules (produced by Shandong New times pharmaceutical Co., Ltd.) and Jingfang mixture (produced by Lunan Thick pharmaceutical Co., Ltd.). In the clinical use process of the Jingfang preparation, the Jingfang preparation is unexpectedly found to improve clinical symptoms of abdominal pain, abdominal distension, nausea, vomiting and the like of a patient to a certain extent for the individual patient suffering from pancreatitis.

Based on the clinical use feedback of the Jingfang preparation, the inventor carries out a series of developments on the application of the Jingfang preparation in the treatment of digestive internal diseases. In order to verify the efficacy of the Jingfang preparation in treating the digestive system diseases, particularly pancreatitis, the inventor carries out animal experimental research, the following description only takes an acute pancreatitis experimental model as an example, and the inventor also carries out pharmacological experimental research on other digestive system diseases, chronic pancreatitis and the like recorded in the specification.

Experimental example 1 Effect of drugs on acute pancreatitis in rats

1 Material

1.1 Experimental animals healthy male SD rats, 60, body weights (200 + -20) g, provided by Jinanpunyue Experimental animals Breeding Co., Ltd., Experimental animal license number: SCXK (lu) 2014007. The method is characterized in that the animal is bred adaptively for 1 week in a clean-grade animal laboratory before experiment, male and female parts are separated, the room temperature is 20-25 ℃, the relative humidity is 40% -60%, natural illumination is carried out, and free food intake and drinking are carried out.

1.2 electronic analytical balance model AG285 electronic analytical balance (Mettler-Toledo, Switzerland), full-automatic biochemical analyzer (Beckmann Kulter Co., Ltd., USA), low-temperature high-speed centrifuge (Sigma Co., USA), and electric heating thermostat water bath kettle model GB11240-89 (Beijing medical equipment Provisions Corp.); rat TNF-alpha, IL-6, SOD, MDA enzyme-linked immunosorbent assay kit (Sigma company, USA); sodium taurolite (Sigma, usa), sodium pentobarbital (chemical ltd. hongbo, dennan); the tested drug is Jingfang granules (produced by Shandong New Times pharmaceutical Co., Ltd.), and the positive control drug is gabexate mesylate (produced by Changzhou Siyao pharmaceutical Co., Ltd.).

2 method

2.1 grouping and administration of drugs 60 healthy SD rats were selected and randomly divided into 6 groups, namely, a sham operation group, a model control group, a gabexate mesylate positive control group (referred to as a "positive control group"), a Jingfang granule high dose group (referred to as a "test high dose group"), a Jingfang granule medium dose group (referred to as a "test medium dose group") and a Jingfang granule low dose group (referred to as a "test low dose group"), each group consisting of 10 rats, each half of which is male and female. Except for the sham operation group, the other 5 groups of rats are all established into an acute pancreatitis rat model by adopting a retrograde cholangiopancreatic injection method of 5% sodium taurocholate solution, and the concrete steps are as follows: rats were fasted for 12 hours before surgery, but water was not contraindicated. Injecting 2.5% pentobarbital sodium solution (1ml/kg) into an abdominal cavity for anesthesia, performing routine disinfection on the skin at the upper middle part of an abdominal wall by using 75% alcohol, descending an abdominal median incision under aseptic conditions, opening the abdominal cavity, lifting the stomach and duodenum, finding a pancreatic duct opening, incising the duodenum at a position about 15mm below the opening, placing a plastic tube (30 mm in length and 3mm in diameter) into the plastic tube, respectively ligating the far end and the near end of the pancreatic duct opening, ligating the far end of the duodenal incision to form a 20 mm-long duodenal closed loop, then injecting 0.3ml of 5% sodium taurocholate solution into the closed loop, filling the closed loop, flowing back into the pancreatic duct, closing the abdomen, and limiting drinking water after operation. The sham group only opened the abdominal cavity and gently turned the pancreas and closed the abdomen.

2.2 after the drug is administered and the model is constructed for 30min, the drug is administered according to the dose conversion coefficients of different animals in the appendix of the guidelines on clinical research of new traditional Chinese medicines, wherein the positive control group is injected with 0.01g/kg of gabexate mesylate in the abdominal cavity, the test high dose group, the test medium dose group and the test low dose group are sequentially drenched with 9.0g/kg (2 times of the human dose), 4.5g/kg (1 time of the human dose) and 2.25g/kg (0.5 time of the human dose), and the sham operation group and the model control group are drenched with normal saline with equal volume.

2.3 detection index and method

12 hours after administration, rats were anesthetized with 2.5% sodium pentobarbital solution. Blood was collected from the inner canthus of the eye, and then the rats were sacrificed to take pancreatic tissue and stored in centrifuge tubes at-80 ℃ in a refrigerator.

(1) Determination of serum Amylase (AMS) and serum Lipase (LPS) activities in serum: blood is taken from the inner orbit of the eye of each group of rats, centrifugation is carried out for 10min at 5000r/min under the condition of low temperature, the upper serum is taken, and the activity level of AMS and LPS is measured by a full-automatic biochemical analyzer.

(2) Measuring the content of inflammatory cytokines TNF-alpha and IL-6 in serum: blood is taken from the inner orbit of the eye of each group of rats, centrifugation is carried out for 10min at 5000r/min under the condition of low temperature, the upper serum is taken, the TNF-alpha and IL-6 levels of the serum are detected by adopting an ELISA method, and the measurement of each index is strictly operated according to the instruction of a kit.

(3) Determination of pancreatic tissue SOD and MDA: taking part of pancreatic tissue, washing, drying with absorbent paper, weighing, placing into a 10ml centrifugal tube, adding appropriate amount of normal saline, homogenizing to obtain 10% tissue homogenate, centrifuging at 4 deg.C for 10min at 3500r/min, and collecting supernatant to determine SOD activity level and MDA content. The measurement of each index was carried out strictly according to the kit instructions.

2.4 statistical processing SPSS19.0 statistical software was used for analysis, and experimental data were expressed as mean. + -. standard deviation

"is expressed in terms of form. The comparison among groups adopts one-factor analysis of variance toP < 0.05 indicates that the difference is statistically significant.

3 results

(1) Compared with a sham operation group, the AMS and LPS activity in the serum of the rat of the model control group is obviously improved, and the difference has statistical significance (P is less than 0.05), which indicates that the acute pancreatitis rat model of the experiment is successful. Compared with the model control group, the AMS and LPS activity in the serum of the rats of the positive control group and the experimental high, medium and low dose groups is obviously reduced, and the difference has statistical significance (P is less than 0.05). The results show that the Jingfang granules can effectively treat acute pancreatitis. The results are shown in Table 1.

TABLE 1 Effect of Jingfang granules on AMS and LPS Activity in rats with acute pancreatitis: (

n＝10)

Note: comparison with sham group: p < 0.05 is denoted by "+"; comparison with model control group: p < 0.05 is indicated by "A".

(2) Compared with a sham operation group, the contents of inflammatory cytokines TNF-alpha and IL-6 in the serum of the rat of the model control group are obviously increased, and the differences have statistical significance (P is less than 0.05), which indicates that the acute pancreatitis rat model of the experiment is successful. Compared with the model control group, the positive control group and the experimental high, medium and low dose groups have obviously reduced contents of TNF-alpha and IL-6 in the rat serum, and the difference has statistical significance (P is less than 0.05). The results show that the Jingfang granules can play a role in relieving the inflammatory reaction of rats with acute pancreatitis to a certain extent by inhibiting the release of inflammatory cytokines TNF-alpha and IL-6. The results are shown in Table 2.

TABLE 2 Effect of Jingfang granules on TNF-alpha and IL-6 levels in rats with acute pancreatitis: (

n＝10)

(3) Compared with a sham operation group, the SOD activity in the pancreatic tissues of the rats in the model control group is obviously reduced, the MDA content is obviously increased, and the difference has statistical significance (P is less than 0.05), which indicates that the acute pancreatitis rat model of the experiment is successful. Compared with the model control group, the activity of SOD in pancreatic tissues of rats in the positive control group and the experimental high, medium and low dose groups is obviously improved, the MDA content is obviously reduced, and the difference has statistical significance (P is less than 0.05). The results are shown in Table 3.

TABLE 3 Effect of Jingfang granules on SOD Activity and MDA content in rats with acute pancreatitis: (

n＝10)

The experimental results show that the Jingfang granules can effectively reduce the activity of serum amylase and serum lipase, relieve inflammatory reaction, reduce the release level of inflammatory cytokines TNF-alpha and IL-6 in serum, enhance the activity of SOD in pancreatic tissues, reduce the content of MDA in the tissues and have certain treatment effect on acute pancreatitis.

Detailed Description

The present invention is further illustrated below by specific examples in order to provide those skilled in the art with a full understanding of the present invention, but it should be understood by those skilled in the art that the examples of the present invention are not to be construed as limiting the present invention in any way.

Example 1 preparation of Jingfang granules

D. decocting the residues of the schizonepeta, the divaricate saposhnikovia root, the incised notopterygium rhizome, the doubleteeth pubescent angilica root and the whiteflower hogfennel root obtained in the step A and the rest three medicines of the Chinese thorowax root, the platycodon root, the liquoric root and the like in water for 2 times, 2 hours for each time, combining decoction liquids, filtering, and concentrating the filtrate to an extract with the relative density of 1.;

E. c, combining the percolated liquid obtained in the step C and the extract obtained in the step D, uniformly mixing, standing, filtering, and concentrating the filtrate to an extract with the relative density of 1.25 at 50-60 ℃;

F. and E, belt-type vacuum drying the extract obtained in the step E under the conditions of vacuum degree of-0.08 MPa to-0.10 MPa and drying temperature of 65 ℃, crushing the extract into fine powder, sieving the fine powder, adding the beta-cyclodextrin inclusion compound obtained in the step B, and uniformly mixing the fine powder to obtain the Jingfang extract fine powder, wherein the weight ratio of the extract to the sucrose powder in the formula is as follows: hydroxypropyl starch: mannitol 3: 2: 0.7 excipient, mixing, granulating, drying, and grading.

Example 2 preparation of Jingfang tablets

C. b, preparing the water solution of the distilled hemlock parsley and the bitter orange obtained in the step A into 20 percent ethanol solution as a solvent, and percolating the dregs of the hemlock parsley and the bitter orange obtained in the step A and the tuckahoe to obtain percolate for later use;

D. decocting the residues of the schizonepeta, the divaricate saposhnikovia root, the incised notopterygium rhizome, the doubleteeth pubescent angilica root and the whiteflower hogfennel root obtained in the step A and the rest three medicines of the Chinese thorowax root, the platycodon root, the liquoric root and the like in water for 3 hours, filtering, and concentrating the filtrate to an extract with the relative density of 1.18 at the;

E. c, combining the percolated liquid obtained in the step C and the extract obtained in the step D, uniformly mixing, standing, filtering, and concentrating the filtrate to an extract with the relative density of 1.22 at 50-60 ℃;

F. and E, belt-type vacuum drying the extract obtained in the step E under the conditions of vacuum degree of-0.08 MPa to-0.10 MPa and drying temperature of 63 ℃, crushing the extract into fine powder, sieving the fine powder, adding the beta-cyclodextrin inclusion compound obtained in the step B, uniformly mixing the fine powder to obtain the Jingfang extract fine powder, adding the starch, the dextrin and the sucrose (weight ratio is 5: 1: 2) in a formula amount, uniformly mixing the mixture to prepare coarse granules, drying, crushing, sieving, granulating, drying at low temperature, finishing granules, adding 0.35% of magnesium stearate, uniformly mixing, and pressing the mixture into 10000 tablets to obtain the Jingfang extract.

Example 3 preparation of Jingfang capsules

C. b, preparing a 30% ethanol solution of the distilled water solution of the ligusticum wallichii and the fructus aurantii obtained in the step A as a solvent, and percolating the residues of the ligusticum wallichii and the fructus aurantii obtained in the step A and the poria cocos to obtain a percolate for later use;

D. decocting the residues of the schizonepeta, the divaricate saposhnikovia root, the incised notopterygium rhizome, the doubleteeth pubescent angilica root and the whiteflower hogfennel root obtained in the step A and the rest three medicines of the Chinese thorowax root, the platycodon root, the liquoric root and the like in water for 3 times, wherein each time lasts for 1 hour, combining the decoction, filtering the decoction, and concentrating the filtrate to an extract with the relative;

E. c, combining the percolated liquid obtained in the step C and the extract obtained in the step D, uniformly mixing, standing, filtering, and concentrating the filtrate to an extract with the relative density of 1.28 at 50-60 ℃;

F. and E, belt-type vacuum drying the extract obtained in the step E under the conditions of vacuum degree of-0.08 MPa to-0.10 MPa and drying temperature of 67 ℃, crushing the extract into fine powder, sieving the fine powder, adding the beta-cyclodextrin inclusion compound obtained in the step B, uniformly mixing the fine powder to obtain the Jingfang extract fine powder, adding the starch and the microcrystalline cellulose (the weight ratio is 6: 1) in a formula amount, uniformly mixing, granulating, drying, grading, filling, polishing in a polishing machine, and removing damaged capsules to obtain the Jingfang extract.

EXAMPLE 4 preparation of Jingfang oral liquid

C. b, preparing a 22% ethanol solution of the water solution of the distilled rhizoma ligustici wallichii and the fructus aurantii obtained in the step A as a solvent, and percolating the residues of the rhizoma ligustici wallichii and the fructus aurantii obtained in the step A and the poria cocos to obtain a percolate for later use;

D. decocting the residues of the schizonepeta, the divaricate saposhnikovia root, the incised notopterygium rhizome, the doubleteeth pubescent angilica root and the whiteflower hogfennel root obtained in the step A and the rest three medicines of the Chinese thorowax root, the platycodon root, the liquoric root and the like in water for 2 times, 2.5 hours for each time, combining the decoctions, filtering, and concentrating the filtrate to an extract with the relative density of 1.;

E. c, combining the percolated liquid obtained in the step C and the extract obtained in the step D, uniformly mixing, standing, filtering, and concentrating the filtrate to an extract with the relative density of 1.23 at 50-60 ℃;

F. and E, adding the cyclodextrin inclusion compound obtained in the step B, 32g of sodium benzoate and 2.1kg of cane sugar into the extract obtained in the step E, adding water to 10L, uniformly stirring, refrigerating for 24 hours, filtering, adjusting the pH value to 7.3 by using a sodium hydroxide solution, encapsulating, and sterilizing to obtain the cyclodextrin inclusion compound.

Example 5 preparation of Jingfang microcapsules

C. b, preparing 27% ethanol solution of the water solution of the distilled rhizoma ligustici wallichii and the fructus aurantii obtained in the step A as a solvent, and percolating the residues of the rhizoma ligustici wallichii and the fructus aurantii obtained in the step A and the poria cocos to obtain percolate for later use;

D. decocting the residues of the schizonepeta, the divaricate saposhnikovia root, the incised notopterygium rhizome, the doubleteeth pubescent angilica root and the whiteflower hogfennel root obtained in the step A and the rest three medicines of the Chinese thorowax root, the platycodon root, the liquoric root and the like in water for 3 times, wherein each time lasts for 1.5 hours, combining the decoctions, filtering the decoction, and concentrating the filtrate to an extract with the relative;

E. c, combining the percolated liquid obtained in the step C and the extract obtained in the step D, uniformly mixing, standing, filtering, and concentrating the filtrate to an extract with the relative density of 1.27 at 50-60 ℃;

F. adding the cyclodextrin clathrate obtained in step B into the fluid extract obtained in step E, mixing, granulating, belt-type vacuum drying at 55 deg.C under vacuum degree of-0.08 MPa-0.10 MPa, and pulverizing to obtain herba Schizonepetae extract fine powder;

G. weighing fine powder of the Jingfang extract in the step F and sodium complexing protein according to the formula: maltodextrin 3:2 mixture as capsule wall material, octadecanol: titanium dioxide 3: 1 is antiadherent, polyethylene glycol: citric acid ═ 3: adding the capsule wall material, the anti-sticking agent and the plasticizer into purified water, heating and stirring at 55 ℃ to dissolve the capsule wall material, preparing a capsule wall material solution with the mass fraction of 34%, cooling to room temperature, adding the fine powder of the Jingfang extract under stirring, and adding 1.19% of sucrose fatty acid ester of the total amount of the preparation formula: homogenizing and emulsifying soybean phospholipid 8: 5 composite emulsifier to obtain emulsion;

H. and G, carrying out spray drying on the emulsion in the step G under the conditions of air inlet temperature of 162 ℃, spray pressure of 0.45MPa and feeding speed of 22.5ml/min, collecting the microcapsules, and cooling to obtain the microcapsule.

Example 6 preparation of a Jingfang mixture

Example 7 preparation of Jingfang granules

EXAMPLE 8 preparation of Jingfang mixture

Claims

1. The application of a traditional Chinese medicine composition in preparing a medicine for preventing or treating digestive internal diseases is characterized in that the traditional Chinese medicine composition is prepared from the following traditional Chinese medicine components: herba schizonepetae, radix sileris, notopterygium root, radix angelicae pubescentis, radix bupleuri, radix peucedani, rhizoma ligustici wallichii, fructus aurantii immaturus, poria cocos, platycodon grandiflorum and liquorice.

2. The use of claim 1, wherein the digestive medical disease includes, but is not limited to, pancreatitis.

3. The use of claim 2, wherein said pancreatitis comprises acute pancreatitis and chronic pancreatitis.

4. Use according to claim 2, wherein said pancreatitis includes, but is not limited to, pancreatitis caused by viral infection, alcoholism, biliary tract disease, metabolic disorders.

5. The use of claim 2, wherein said pancreatitis is viral pancreatitis.

6. The use of claim 1, wherein the Chinese medicinal composition is prepared from the following Chinese medicinal components:

7. the use of claim 1, wherein the Chinese medicinal composition is prepared from the following Chinese medicinal components:

8. the use of claim 1, wherein the Chinese medicinal composition is an oral pharmaceutical formulation.

9. The use of claim 8, wherein the oral pharmaceutical formulation is one of granules, tablets, capsules, oral liquid, mixture, syrup or microcapsules.

10. Use according to claim 8 or 9, wherein the process for the preparation of the oral pharmaceutical formulation comprises the following steps: