CN112353863A - Application of Jingfang preparation in preparation of medicine for treating gastric ulcer and preparation method of Jingfang preparation - Google Patents

Application of Jingfang preparation in preparation of medicine for treating gastric ulcer and preparation method of Jingfang preparation Download PDF

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CN112353863A
CN112353863A CN202011009484.8A CN202011009484A CN112353863A CN 112353863 A CN112353863 A CN 112353863A CN 202011009484 A CN202011009484 A CN 202011009484A CN 112353863 A CN112353863 A CN 112353863A
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root
extract
preparation
jingfang
volatile oil
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关永霞
邵明杰
杜昊忱
郝大伟
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Lunan Pharmaceutical Group Corp
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Lunan Pharmaceutical Group Corp
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    • A—HUMAN NECESSITIES
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    • A61K36/185—Magnoliopsida (dicotyledons)
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    • A61K47/6949—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes
    • A61K47/6951—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes using cyclodextrin
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    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
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Abstract

The invention discloses an application of a Jingfang preparation in preparing a medicine for treating gastric ulcer and a preparation method thereof, belonging to the field of medicines. The Jingfang preparation is prepared from 11 raw material medicines 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 has the effects of sweating, relieving exterior syndrome, dispelling wind and. The Jingfang preparation can effectively treat stress gastric ulcer and chronic gastric ulcer caused by acetic acid, inhibit gastric acid secretion, reduce free acid and total acidity in gastric juice, simultaneously has the function of reducing the activity of pepsin, treats both principal and secondary aspects of diseases, and has exact treatment effect on gastric ulcer.

Description

Application of Jingfang preparation in preparation of medicine for treating gastric ulcer and preparation method of Jingfang preparation
Technical Field
The invention relates to application of a Jingfang preparation and a preparation method thereof, in particular to application of the Jingfang preparation in preparation of a medicine for treating gastric ulcer and a preparation method thereof, and belongs to the field of traditional Chinese medicines.
Background
Gastric Ulcer (Gastric Ulcer) belongs to one of peptic ulcers, and particularly refers to ulcers occurring in the Gastric horn, antrum, cardia, and hiatal hernia. Gastric ulcer is more clinically manifested than other peptic ulcers, and is typically manifested by chronic, periodic, and rhythmic postprandial pain in the upper abdomen, and may also be accompanied by digestive tract symptoms such as dyspepsia, nausea, vomiting, and belching. In the onset of gastric ulcer, helicobacter pylori infection is the main cause of gastric ulcer induction, and gastric acid and pepsin-induced mucosal autodigestion are the main damage factors leading to ulcer formation, and the view of 'acid-free and ulcer-free' is generally agreed. Gastric ulcer is the most common digestive system disease in clinical digestive internal medicine, is mostly caused in middle-aged and elderly people of 40-60 years old, has long course of disease, is easy to relapse, can cause upper gastrointestinal hemorrhage, gastric perforation and other diseases, and even can possibly cause canceration. In recent years, with the accelerated social rhythm, the incidence of gastric ulcer caused by irregular diet, excessive pressure and the like of people is increased year by year, and the work and life of patients are seriously influenced.
At present, aiming at the pathogenesis and the pathogenesis characteristics of gastric ulcer, the western medicine treatment of gastric ulcer mainly takes antacid and helicobacter pylori resistance as main components, and the treatment medicines mainly comprise antacid (sodium bicarbonate and sodium hydroxide), proton pump inhibitor (omeprazole, lansoprazole, and the like), H2 receptor blocker (cimetidine, ranitidine, famotidine, and the like), gastric mucosa protective agent (misoprostol, and the like), helicobacter pylori resistance medicine (metronidazole, and the like), and the like. According to traditional Chinese medicine, gastric ulcer belongs to the categories of epigastric pain, gastric abscess, stomach deficiency, spleen and stomach deficiency-cold and the like, and is mainly caused by emotional stimulation, improper diet, incoordination between liver and stomach and spleen and stomach injury, liver and stomach incoordination, spleen and stomach deficiency-cold, liver and stomach stagnated heat, blood stasis blocking collaterals, stomach yin deficiency and other symptoms. In recent years, the traditional Chinese medicine treatment for gastric ulcer gradually draws attention and attention of people, however, the traditional Chinese medicine preparation for treating gastric ulcer in the current market is complex in components, has many adverse reactions and has a non-obvious effect.
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. The monarch drugs of the prescription, namely the schizonepeta and the divaricate saposhnikovia root, which are pungent and warm in nature, can induce sweat, release exterior and dissipate wind evil, and eliminate the first disease of all diseases; ministerial drugs of notopterygium root and radix angelicae pubescentis are pungent and warm in nature and disperse, wind-cold-damp evil in upper and lower parts of the body is cured, ligusticum wallichii is capable of promoting blood circulation and dispelling wind, radix bupleuri is pungent and disperse to release muscles, notopterygium root and radix angelicae pubescentis are capable of dispelling exogenous evil and relieving pain; fructus Aurantii is used for depressing qi, radix Platycodi is used for opening lung, radix Peucedani is used for eliminating phlegm, Poria is used for eliminating dampness, and radix Glycyrrhizae is used as adjuvant drug and guiding drug. The combination of the medicines can cure the disease by sweating and fever abatement, blood circulation and wind pain elimination, lung qi promotion, phlegm dampness elimination, cough elimination and cold elimination. 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.
In the clinical application process of the Jingfang preparation, the inventor finds that the Jingfang preparation has the effect of treating gastric ulcer. Pharmacodynamic tests show that the Jingfang preparation is an effective prescription for treating gastric ulcer, can effectively resist stress gastric ulcer and chronic gastric ulcer caused by acetic acid, can inhibit gastric acid secretion, reduce free acid and total acidity in gastric juice, has the effect of reducing the activity of pepsin, has exact and obvious treatment effect on gastric ulcer, can achieve the effect of treating both symptoms and root causes, provides a new choice for clinical medication, and embodies the curative effect characteristics of the compound traditional Chinese medicine, such as integrity, multiple target spots and multiple component synergistic effect.
Disclosure of Invention
The invention aims to provide application of a Jingfang preparation in preparation of a medicine for treating gastric ulcer. The prescription Jingfang preparation of the invention is derived from ancient prescription Jingfang antiphlogistic powder, and series Jingfang preparations such as Jingfang granules, Jingfang tablets and the like are prepared by relying on the prior art. The application of the invention is discovered in the clinical application process of company medicines, and then proved by related pharmacodynamic tests, the invention has greater commercial value.
The application of the Jingfang preparation in preparing the medicine for treating the gastric ulcer is characterized in that the Jingfang preparation is prepared from the following traditional Chinese medicine components:
Figure BDA0002697101980000021
preferably:
Figure BDA0002697101980000022
the test result shows that the Jingfang preparation can effectively resist stress gastric ulcer and chronic gastric ulcer caused by acetic acid, inhibit gastric acid secretion, reduce free acid and total acidity in gastric juice, simultaneously has the function of reducing the activity of pepsin, treats both principal and secondary aspect of disease, and has exact and obvious treatment effect on the gastric ulcer.
The invention also aims to provide a traditional Chinese medicine oral preparation containing the traditional Chinese medicine composition and a preparation method thereof, wherein the traditional Chinese medicine oral preparation is one of granules, tablets, capsules and microcapsules.
The preparation method of the traditional Chinese medicine oral 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. b, 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 2-3 times, wherein each time lasts for 1.5-2.5 hours, merging decoction, filtering, and concentrating the filtrate to an extract with the relative density of 1.18-1.;
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.
The preferred dosage form of the present invention is a granule, and the preparation method of the granule 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 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.
Another preferred dosage form of the present invention is a pellet formulation, and the method for preparing the microcapsule formulation 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 a 28% 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 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 1.25 at 50-60 ℃;
F. taking the clear paste obtained in the step E, adding the cyclodextrin inclusion compound obtained in the step B, uniformly mixing, preparing into granules, carrying out belt type vacuum drying, and crushing to obtain fine powder of the Jingfang extract for later use;
G. weighing the fine powder of the Jingfang extract, the capsule wall material, the anti-sticking agent and the plasticizer in the step F according to the formula, adding the capsule wall material, the anti-sticking agent and the plasticizer into purified water, heating and stirring at 54 ℃ to dissolve the capsule wall material, preparing a capsule wall material solution with the mass fraction of 33%, cooling to room temperature, adding the fine powder of the Jingfang extract and the emulsifier in a stirring state, homogenizing and emulsifying to obtain an emulsion for later use;
H. and G, carrying out spray drying on the emulsion in the step G under the conditions of air inlet temperature of 165 ℃, spray pressure of 0.40MPa and feeding speed of 21.5ml/min, collecting the microcapsules, and cooling to obtain the microcapsule.
Preferably, the belt type vacuum drying condition in the step F is vacuum degree of-0.08 MPa-0.10 MPa, and the drying temperature is 56 ℃.
Preferably, the capsule material in the step G is sodium complexing protein: maltodextrin 3:2, anti-tack agent octadecanol: titanium dioxide 3: 1, the plasticizer is polyethylene glycol: citric acid ═ 3: 1.
preferably, the emulsifier of step C is a sucrose fatty acid ester: the soybean lecithin is 8: 5 of the composite emulsifier, and the dosage of the composite emulsifier is 1.18 percent of the total amount of the preparation formula according to the mass fraction.
In order to verify the effect of the Jingfang preparation on treating gastric ulcer, the inventor carries out corresponding animal test research. It should be noted that the animal experimental study is selected from the representative formula and the preparation method thereof, and the other formulas and products obtained by the preparation method thereof involved in the invention relate to the experiment and the result thereof, which are not exhaustive due to space limitation.
Experimental example 1 Effect of drugs on stress gastric ulcer in mice
1 Material
1.1 healthy KM mice of experimental animals, half each male and female, 60 mice, body weight (20 + -2) g, provided by Lunan pharmaceutical group, Inc., and license number of experimental animals: SYXK (lu) 20180008. 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 Instrument, reagents and drug AG285 model electronic analytical balance (Mettler-Toledo, Switzerland), SZX12 dissecting microscope (Olympus, Japan); formaldehyde (shanghai alatin biochemical science and technology, ltd); the test drug was the Jingfang granules (manufactured by Shanghai pharmaceutical Co., Ltd., Shandong province) of example 4, the positive control drug was the omeprazole capsule (batch No. 19069001, Ryokun Rudekang pharmaceutical technology Co., Ltd., Beijing), and the negative control drug was the Schizonepeta radix Saposhnikoviae compound granules (manufactured by Shanghai pharmaceutical Co., Ltd., Shang province) of comparative example 1.
2 method
2.1 healthy KM mice were divided into 6 groups, i.e., a model control group, an omeprazole capsule positive control group (abbreviated as "positive control group"), a schizonepeta and ledebouriella compound granule negative control group (abbreviated as "negative control group"), a schizonepeta and ledebouriella compound granule high-dose group (abbreviated as "test high-dose group"), a schizonepeta and ledebouriella granule medium-dose group (abbreviated as "test medium-dose group"), and a schizonepeta and ledebouriella granule low-dose group (abbreviated as "test low-dose group"), each group containing 10 mice each with half of male and female. The groups are subjected to intragastric administration, dose reduction is carried out according to dose reduction coefficients of different animals in annexes in the clinical research guiding principle of new traditional Chinese medicines, a positive control group is subjected to intragastric administration by 0.008g/kg of omeprazole capsules, a negative control group is subjected to intragastric administration by 7.5g/kg of schizonepeta and radix sileris compound granules, a test high dose group, a test medium dose group and a test low dose group are respectively subjected to intragastric administration by 9g/kg, 4.5g/kg and 2.25g/kg of schizonepeta and radix sileris compound granules, equivalent to 2 times, 1 time and 0.5 time of human equivalent dose, the administration volume is 10ml/kg, a model control group is subjected to administration by equal-volume physiological saline, and administration is carried out 1 time per day for 6 days continuously.
2.2 test criteria and methods fasting without water was started after the administration on day 5, and 1 hour after the administration on day 6, the limbs of each group of mice were fixed on a template and immersed in water at (20. + -. 1) ° C for 16 hours (overnight). The animals were removed, sacrificed, dissected and ligated to the pylorus and cardia, respectively, and 1 ml/piece of 1% formaldehyde solution was injected into the stomach. After fixation for 10 minutes, the stomach wall was cut along the greater curvature of the stomach, laid flat on a light-transmitting glass plate, the number of ulcer points in the glandular stomach was read under a dissecting mirror, and the ulcer inhibition rate was calculated.
Ulcer inhibition (%) as ═ total number of ulcer points in model control group-total number of ulcer points in each administration group/total number of ulcer points in model control group × 100%
2.3 statistical processing SPSS19.0 statistical software was used for analysis, and the experimental data were expressed as "mean. + -. standard deviation
Figure BDA0002697101980000051
"is expressed in terms of form. The comparison among groups was performed by one-way anova, with P < 0.05 indicating that the difference was statistically significant.
3 results
Compared with a model control group, the number of ulcer points of mice in a positive control group and a test high, medium and low dose group is obviously reduced, and the difference has statistical significance (P is less than 0.05), wherein the ulcer inhibition rate of the test high dose group is as high as 68.4%; compared with a model control group, the number of ulcer points of a negative control group mouse is slightly reduced, and no significant difference exists; compared with a negative control group, the number of ulcer points of mice in a high, medium and low dose group is obviously reduced, the difference has statistical significance (P is less than 0.05), and the ulcer inhibition rate is obviously increased. The above results indicate that the Jingfang granules can effectively resist the stress gastric ulcer of the mice. The results are shown in Table 1.
TABLE 1 Effect of Jingfang granules on stress gastric ulcer in mice: (
Figure BDA0002697101980000061
n＝10)
Figure BDA0002697101980000062
Note: comparison with model control group: p < 0.05 is denoted by "+"; comparison with negative control group: p < 0.05 is indicated by "A".
Experimental example 2 Effect of drug on acetic acid-induced chronic gastric ulcer in rat model
1 Material
1.1 experimental animal SPF grade SD rat, half of male and female, 60, weight (200 + -20) g, provided by Jinanpunyue experimental animals breeding Limited, the license number of experimental animal: SCXK (lu) 20190003. 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 instruments, reagents and medicines AG285 type electronic analytical balance (Mettler-Toledo, Switzerland), 02764 type electric heating constant temperature water bath (Shanghai) instruments science and technology, Inc.), GL-20A full-automatic freezing high speed centrifuge (Hunan instruments and meters general works centrifuge factory); chloral hydrate, glacial acetic acid, formaldehyde (shanghai alatin biochem technologies ltd.); the test drug was the Jingfang granules (manufactured by Shanghai pharmaceutical Co., Ltd., Shandong province) of example 4, the positive control drug was the omeprazole capsule (batch No. 19069001, Ryokun Rudekang pharmaceutical technology Co., Ltd., Beijing), and the negative control drug was the Schizonepeta radix Saposhnikoviae compound granules (manufactured by Shanghai pharmaceutical Co., Ltd., Shang province) of comparative example 1.
2 method
2.1 grouping and administration of groups 60 SD rats were taken, fasted and water was not prohibited for 24h, anesthetized by intraperitoneal injection with 10% chloral hydrate (3.5mL/kg), the abdominal wall was cut longitudinally about 2cm under the xiphoid process by 0.5cm, the stomach was found, and the abdominal wall was removed gently. A glass tube with the inner diameter of 5mm and the length of 30mm is vertically arranged on a gastric body serosa layer, 0.2mL of glacial acetic acid is added into the glass tube, and the glacial acetic acid is dipped by a cotton swab after 1.5 min. After the above operations are completed, the stomach is gently returned to the abdominal cavity, the omentum is covered, and tissues of the peritoneum and the abdominal wall are sutured.
After normal diet, animals are randomly divided into 6 groups on the next day, namely a model control group, an omeprazole capsule positive control group (called as a ' positive control group ' for short), a schizonepeta and ledebouriella compound particle negative control group (called as a ' negative control group ' for short), a schizonepeta and ledebouriella compound particle high-dose group (called as a ' test high-dose group ' for short), a schizonepeta and ledebouriella particle medium-dose group (called as a ' test medium-dose group ' for short) and a schizonepeta and ledebouriella particle low-dose group (called as a ' test low-dose group. The groups are subjected to intragastric administration, dose reduction is carried out according to dose reduction coefficients of different animals in annexes in the clinical research guiding principle of new traditional Chinese medicines, a positive control group is subjected to intragastric administration by 0.008g/kg of omeprazole capsules, a negative control group is subjected to intragastric administration by 3.75g/kg of schizonepeta and radix sileris compound granules, a test high dose group, a test medium dose group and a test low dose group are sequentially subjected to intragastric administration by 9g/kg, 4.5g/kg and 2.25g/kg of schizonepeta and radix sileris compound granules, equivalent to 2 times, 1 time and 0.5 time of human equivalent dose, the administration volume is 10ml/kg, a model control group is subjected to administration by equal-volume physiological saline, 1 time per day and 14 days of continuous administration.
2.2 test indexes and method after last administration on day 14, after fasting for 1h, rats are deeply anesthetized by intraperitoneal injection of 10% chloral hydrate by 1mL, laparotomy is performed, 3-5mL of blood is taken from abdominal aorta, after heat preservation is performed for 30min in water bath at 36-37 ℃, 3500r/min is centrifuged for 10min, supernatant is taken for standby, pylorus and cardia are ligated, and 10mL of 4% formaldehyde solution is injected from pylorus. Taking stomach, fixing in formaldehyde solution for 15min, cutting along the greater curvature of stomach to promote appetite, spreading on glass plate, and measuring the transverse and vertical diameter d of ulcer1、d2Calculating the ulcer area S (mm)2) As an ulcer index, and an ulcer inhibition rate was calculated.
Ulcer area S ═ pi × d1/2×d2/2
Ulcer inhibition (%) as ═ total ulcer area of model control group-total ulcer area of each administration group/total ulcer area of model control group × 100%
2.3 statistical processing SPSS19.0 statistical software was used for analysis, and the experimental data were expressed as "mean. + -. standard deviation
Figure BDA0002697101980000073
"is expressed in terms of form. The comparison among groups was performed by one-way anova, with P < 0.05 indicating that the difference was statistically significant.
3 results
Compared with a model control group, the ulcer indexes of rats in a positive control group and a high-dose, medium-dose and low-dose test group are obviously reduced, and the difference has statistical significance (P is less than 0.05), wherein the ulcer inhibition rate of the high-dose test group is as high as 62.8%; the ulcer index of the negative control group rats is slightly reduced, and no significant difference exists; compared with a negative control group, the ulcer indexes of rats in the high, medium and low dose groups are obviously reduced, the difference has statistical significance (P is less than 0.05), and the ulcer inhibition rate is obviously improved. The above results indicate that Jingfang granules are effective against acetic acid induced chronic gastric ulcer in rats. The results are shown in Table 2.
TABLE 2 Effect of Jingfang granules on acetic acid induced ulceration in rats: (
Figure BDA0002697101980000071
n＝10)
Figure BDA0002697101980000072
Note: comparison with model control group: p < 0.05 is denoted by "+"; comparison with negative control group: p < 0.05 is indicated by "A".
Experimental example 3 Effect of drug on amount of gastric juice, free acid and total acidity of gastric juice, and pepsin activity in rat
1 Material
1.1 experimental animal SPF grade SD rat, half of male and female, 60, weight (200 + -20) g, provided by Jinanpunyue experimental animals breeding Limited, the license number of experimental animal: SCXK (lu) 20190003. 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 instruments, reagents and medicines of pentobarbital, sodium hydroxide, hydrochloric acid (Jinan Hongbo chemical Co., Ltd.), and phenolphthalein reagent (Shanghai Michelin Biochemical technology Co., Ltd.); model 02764 electric heating thermostat water bath (shanghai instrument science and technology, inc.), T6200 drying box (siemer feishel science and technology, usa), capillary glass tube (changzhou kogaku crystal glass, inc.), and model AG285 electronic analytical balance (Mettler-Toledo, switzerland); the test drug was the Jingfang granules (manufactured by Shanghai pharmaceutical Co., Ltd., Shandong province) of example 4, the positive control drug was the omeprazole capsule (batch No. 19069001, Ryokun Rudekang pharmaceutical technology Co., Ltd., Beijing), and the negative control drug was the Schizonepeta radix Saposhnikoviae compound granules (manufactured by Shanghai pharmaceutical Co., Ltd., Shang province) of comparative example 1.
2 method
2.1 SD rats are divided into groups and molded, 60 SD rats are randomly divided into 6 groups, namely a model control group, an omeprazole capsule positive control group (short for a positive control group), a schizonepeta and ledebouriella compound particle negative control group (short for a negative control group), a schizonepeta and ledebouriella compound particle high-dose group (short for a test high-dose group), a schizonepeta and ledebouriella particle medium-dose group (short for a test high-dose group) and a schizonepeta and ledebouriella particle low-dose group (short for a test low-dose group), and 10 rats are divided into half of each group. After fasting for 24h, the rats were individually subjected to gavage. The dose is converted according to dose conversion coefficients of different animals in annexes in the clinical research guiding principle of new traditional Chinese medicines, a positive control group is filled with 0.008g/kg of omeprazole capsules, a negative control group is filled with 3.75g/kg of schizonepeta and radix sileris compound granules, a test high dose group, a test medium dose group and a test low dose group are sequentially filled with 9g/kg, 4.5g/kg and 2.25g/kg of schizonepeta and radix sileris granules, which are equivalent to 2 times, 1 time and 0.5 time of equivalent doses for human beings, the administration volume is 10ml/kg, and a model control group is filled with equal-volume physiological saline.
2.2 detection indexes and methods after administration for 1h by rats, 30mg/kg of pentobarbital sodium is injected into the abdominal cavity, the abdominal cavity is cut after anesthesia, a plastic tube with the diameter of about 5mm is inserted into the stomach through the pylorus by the duodenum, and the plastic tube is tied and fixed at the pylorus for collecting gastric juice. Then a plastic tube is inserted into the anterior stomach from the oral cavity through the esophagus, the lower end of the esophagus is tied and fixed, and 1.5ml of physiological saline with the pH value of 7.0 and the temperature of 35 ℃ is slowly injected into the stomach through the tube. Collecting gastric juice flowing out within 1h, and measuring the volume by using a measuring cylinder; measuring free acidity and total acidity of gastric juice in gastric juice by acid-base titration (titration with 0.01mol/L NaOH, phenolphthalein as indicator); pepsin activity was measured by the moter capillary method.
2.3 statistical processing SPSS19.0 statistical software was used for analysis, and the experimental data were expressed as "mean. + -. standard deviation
Figure BDA0002697101980000091
"is expressed in terms of form. The comparison among groups was performed by one-way anova, with P < 0.05 indicating that the difference was statistically significant.
3 results
Compared with the model control group, the rats with positive control group and high, medium and low dosage groups have obviously reduced gastric juice amount, free acid and total acidity of gastric juice and pepsin activity, and the difference has statistical significance (P is less than 0.05); the indexes of the rats in the negative control group are slightly reduced, and no significant difference exists; compared with a negative control group, the gastric fluid volume, free acid and total acidity of gastric juice and the activity of pepsin of mice in high, medium and low dose groups are obviously reduced, and the difference has statistical significance (P is less than 0.05). The results show that the Jingfang granules can effectively inhibit gastric acid secretion, reduce free acid and total acidity in gastric juice and simultaneously have the function of reducing the activity of pepsin. The results are shown in Table 3.
TABLE 3 influence of Jingfang granule on rat stomach fluid amount, free acid and total acidity of gastric juice, and pepsin activity: (
Figure BDA0002697101980000092
n＝10)
Figure BDA0002697101980000093
Note: comparison with model control group: p < 0.05 is denoted by "+"; comparison with negative control group: p < 0.05 is indicated by "A".
The experimental results show that the Jingfang granules can effectively resist stress gastric ulcer and chronic gastric ulcer caused by acetic acid, inhibit gastric acid secretion, reduce free acid and total acidity in gastric juice, simultaneously have the function of reducing the activity of pepsin, and have exact and obvious treatment effect on the gastric ulcer.
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 capsules
Figure BDA0002697101980000094
Figure BDA0002697101980000101
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 29% 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 1.24 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 and the microcrystalline cellulose (the weight ratio is 7: 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 2 preparation of Jingfang tablets
Figure BDA0002697101980000102
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 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 1.22 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: 1) in a formula amount, uniformly mixing the mixture to prepare coarse granules, drying, crushing, sieving, granulating, drying at low temperature, finishing granules, adding 0.3% of magnesium stearate, uniformly mixing the granules and pressing the granules into 10000 tablets to obtain the Jingfang extract.
Example 3 preparation of Jingfang capsules
Figure BDA0002697101980000111
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 hemlock parsley and the bitter orange obtained in the step A into 26 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 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 1.23 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 superfine silica gel powder and the low-substituted hydroxypropyl cellulose (the weight ratio is 5: 1.5: 2) in the formula amount, uniformly mixing the mixture, granulating, drying, grading, filling, polishing in a polishing machine, and removing damaged capsules to obtain the Jingfang extract.
Example 4 preparation of Jingfang granules
Figure BDA0002697101980000112
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 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, the liquoric root and the like in water for 3 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 1.26 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.
EXAMPLE 5 preparation of Jingfang tablets
Figure BDA0002697101980000121
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 a 24% 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 2 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 1.28 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 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 microcrystalline cellulose, the low-substituted hydroxypropyl cellulose and the mannitol (the weight ratio is 4: 3: 0.5) in a formula amount, uniformly mixing the mixture to prepare coarse granules, drying, crushing, sieving, granulating, drying at low temperature, finishing granules, adding 0.2% of magnesium stearate and 0.1% of talcum powder, uniformly mixing, and pressing the mixture into 10000 tablets.
Example 6 preparation of Jingfang granules
Figure BDA0002697101980000131
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 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 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 1.26 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, uniformly mixing the fine powder to obtain the Jingfang extract fine powder, adding the sucrose powder and the dextrin (weight ratio of 3: 2) in the formula amount, uniformly mixing the mixture to prepare granules, drying the granules, and preparing 10kg of granules to obtain the Jingfang extract.
Example 7 preparation of Jingfang microcapsules
Figure BDA0002697101980000132
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 a 28% 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 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 1.25 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 56 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 54 ℃ to dissolve the capsule wall material, preparing a capsule wall material solution with the mass fraction of 33%, cooling to room temperature, adding the fine powder of the Jingfang extract under stirring, and adding 1.18 percent 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 165 ℃, spray pressure of 0.40MPa and feeding speed of 21.5ml/min, collecting the microcapsules, and cooling to obtain the microcapsule.
Example 8 preparation of Jingfang granules
Figure BDA0002697101980000141
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 a 27% 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, 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 1.24 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 sucrose powder, the hydroxypropyl starch and the mannitol (the weight ratio is 4: 2: 0.5) in the formula amount, uniformly mixing the mixture to prepare granules, drying and finishing the granules to prepare 10kg of the extract.
Example 9 preparation of Jingfang capsules
Figure BDA0002697101980000151
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 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 2 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 1.25 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 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 and the superfine silica gel powder (the weight ratio is 3.5: 1) according to the formula amount, uniformly mixing the mixture, granulating, drying, grading, filling, polishing in a polishing machine, and removing damaged capsules to obtain the Jingfang extract.
Comparative example 1 preparation of compound granule of Schizonepeta and Ledebouriella root
Schizonepeta tenuifolia 0.97kg
Radix Saposhnikoviae 0.97kg
A. Extracting volatile oil from herba Schizonepetae and radix Saposhnikoviae respectively to obtain volatile oil of 2 medicinal materials, and collecting the residue after distillation;
B. b, adding the volatile oil obtained in the step A into beta-cyclodextrin respectively to prepare an inclusion compound;
C. b, decocting the schizonepeta herb and divaricate saposhnikovia root dregs obtained in the step A in water for 3 times, each time lasting for 2 hours, combining the decoctions, filtering, and concentrating the filtrate to an extract with the relative density of 1.26 at the temperature of 60-70 ℃;
D. and C, taking the extract obtained in the step C, carrying out belt type vacuum drying under the conditions of vacuum degree of-0.08 MPa to-0.10 MPa and drying temperature of 63 ℃, crushing into fine powder, sieving, adding the beta-cyclodextrin inclusion compound obtained in the step B, and mixing uniformly to obtain fine powder of the Jingfang extract, wherein the weight ratio of the added formula amounts is sucrose powder: hydroxypropyl starch: mannitol 4: 1: 2, mixing, granulating, drying, and grading.

Claims (9)

1. Application of JINGFENG preparation in preparing medicine for treating gastric ulcer is provided.
2. The use according to claim 1, wherein the Jingfang preparation is an oral pharmaceutical preparation, preferably the oral pharmaceutical preparation is one of granules, tablets, capsules and microcapsules.
3. The use of claim 2, wherein the oral pharmaceutical formulation is prepared from the following Chinese medicinal components:
Figure FDA0002697101970000011
preferably, the oral pharmaceutical preparation is prepared from the following traditional Chinese medicine components:
Figure FDA0002697101970000012
4. the use according to claim 2 or 3, wherein the process for the preparation of the oral pharmaceutical formulation 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 herba Schizonepetae, radix Saposhnikoviae, Notopterygii rhizoma, radix Angelicae Pubescentis and radix Peucedani obtained in step A with the rest bupleuri radix, radix Platycodi and Glycyrrhrizae radix in water, filtering, and concentrating the filtrate to obtain extract with relative density of 1.18-1.25 at 60-70 deg.C;
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.
5. The use according to claim 4, wherein the preparation of the granules 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 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.
6. Use according to claim 4, characterized in that the microcapsules are prepared by a process comprising 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 a 28% 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 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 1.25 at 50-60 ℃;
F. taking the clear paste obtained in the step E, adding the cyclodextrin inclusion compound obtained in the step B, uniformly mixing, preparing into granules, carrying out belt type vacuum drying, and crushing to obtain fine powder of the Jingfang extract for later use;
G. weighing the fine powder of the Jingfang extract, the capsule wall material, the anti-sticking agent and the plasticizer in the step F according to the formula, adding the capsule wall material, the anti-sticking agent and the plasticizer into purified water, heating and stirring at 54 ℃ to dissolve the capsule wall material, preparing a capsule wall material solution with the mass fraction of 33%, cooling to room temperature, adding the fine powder of the Jingfang extract and the emulsifier in a stirring state, homogenizing and emulsifying to obtain an emulsion for later use;
H. and G, carrying out spray drying on the emulsion in the step G under the conditions of air inlet temperature of 165 ℃, spray pressure of 0.40MPa and feeding speed of 21.5ml/min, collecting the microcapsules, and cooling to obtain the microcapsule.
7. The method of claim 6, wherein the belt vacuum drying conditions in step F are vacuum degree of-0.08 MPa-0.10 MPa, and drying temperature is 56 ℃.
8. The method of claim 6, wherein step G the capsule material is sodium complexing: maltodextrin 3:2, anti-tack agent octadecanol: titanium dioxide 3: 1, the plasticizer is polyethylene glycol: citric acid ═ 3: 1.
9. the method according to claim 6, wherein the emulsifier of step C is a sucrose fatty acid ester: the soybean lecithin is 8: 5 of the composite emulsifier, and the dosage of the composite emulsifier is 1.18 percent of the total amount of the preparation formula according to the mass fraction.
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