CN109157632A

CN109157632A - It is a kind of to treat epigastric pain Granular formulations and preparation method

Info

Publication number: CN109157632A
Application number: CN201811357557.5A
Authority: CN
Inventors: 汤新; 汤一新
Original assignee: Sichuan Weixing Biotechnology Co Ltd
Current assignee: Sichuan Weixing Biotechnology Co Ltd
Priority date: 2018-11-15
Filing date: 2018-11-15
Publication date: 2019-01-08
Anticipated expiration: 2038-11-15
Also published as: CN109157632B

Abstract

Epigastric pain Granular formulations and preparation method are treated the invention discloses a kind of, belong to Traditional Chinese medicine formula preparation technical field, the present invention provides one kind for epigastric pain obstinate problem caused by a variety of chronic gastropathies such as peptic ulcer in the prior art, non-atrophic gastritis, functional dyspepsia FD, atrophic gastritis, erosive gastritis, provides the Chinese materia medica preparation and preparation method of a kind for the treatment of epigastric pain with a unique characteristic.The present invention especially uses the cureless epigastric pain of conventional method to have significant curative effect treatment epigastric pain using the formula of lily, tartarian buckwheat root and rhizome, walnut kernel, the coptis, evodia rutaecarpa, cuttlebone, fritillaria thunbergii, the root of Dahurain angelica, Rhizoma Chuanxiong, cardamom, prepared RADIX ET RHIZOMA RHEI, dandelion, radix glycyrrhizae preparata composition.The medicinal raw material of selection is easy to get, and safety is good, without any side effects, and low in cost, epigastric pain controls difficulty in relapse after healing, is worth in clinical wide popularization and application.

Description

It is a kind of to treat epigastric pain Granular formulations and preparation method

Technical field

Epigastric pain Granular formulations and preparation method are treated the present invention relates to a kind of, for treating the Chinese medicine preparation of epigastric pain Preparation belongs to Traditional Chinese medicine formula preparation technical field.

Background technique

Stomach trouble is widest a kind of disease in the world, and epigastric pain is then the most common symptom in stomach trouble.According to The number of gastrointestinal disease is died of 60,000,000 or more in World Health Organization's statistics, the whole world every year, and people's in life nearly all can be different Occur to degree acute or chronic stomach trouble, including peptic ulcer, non-atrophic gastritis, functional dyspepsia FD and other Even more serious stomach trouble, and the stomach trouble of any type, all can may be used also with the different epigastric pain of weight, and after curing It can recur at any time.With the quickening of modern life rhythm, the variation of eating condition rises the incidence of epigastric pain even more successively Height, or even it is in the first place of the symptom of all viscera diseases.Gastral cavilty pain symptom caused by treatment many factors how is solved, is become The important topic that medical field faces.

In order to further research and develop the drug to epigastric pain treatment, the present inventor passes through nearly clinical research in 30 years and experience Accumulation, excavate " spleen yin " it is theoretical, propose " spleen yin be in the sheet of the foundation of acquired constitution this ", " spleen yin disease, which becomes, actual situation " etc. It is special to disclose the memory mechanism and clinic of syndrome of deficiency of spleen yin and real example in a variety of diseases from unique visual angle for a series of creative academic ideas Sign has walked out blind area, theoretic forbidden zone and mistaken ideas clinically of the forefathers in spleen yin understanding, has been put forward for the first time and has practiced taste The nature and flavor of spleen drug and classification demonstrate the deficiency of the spleen-yin syndrome of deficiency of stomach yin and control difference, formulated the diagnosis mark of " syndrome of deficiency of spleen yin and real example " Quasi-, Selection drug standard and curative effect judging standard, creation have summed up the spleen yin clinical diagnosis and treatment system of complete set, the present invention " treating epigastric pain particle " unique formula thinking adds and subtracts proportion and its specific preparation method by series, with creativeness Labour invention solves the technology in terms of the gastral cavilty pain of simultaneously sick treatment taste, the lienopathla and stomach or stomach trouble and spleen or even obstinate disease Problem.

Summary of the invention

The present invention provides one kind in the prior art in face of peptic ulcer, non-atrophic gastritis, functional digestive Common taste and the sick, lienopathla and stomach or stomach trouble and spleen draw in a variety of chronic gastropathies such as bad, atrophic gastritis, erosive gastritis The epigastric pain obstinate problem risen is guidance with the deficiency of the spleen-yin theory, provides treatment epigastric pain Granular formulations and preparation side Method is shown in abdominal fullness and distention, indigestion and loss of appetite deficiency of food, fatigue and weakness, the symptoms such as dry and hard excrement for solving treatment epigastric pain companion.The present invention Granula selects high-quality Chinese medicine formula, has the effect of stomach function regulating benefiting yin, removing toxic substances stagnation resolvation, regulating qi-flowing for relieving pain, not only facilitates Digestive Function of uniting it is perfect, additionally it is possible to enhance Abwehrkraft des Koepers, improve body's immunity, it is right to achieve the effect that treating both manifestation and root cause of disease Treating epigastric pain has significant curative effect, provides the clinic side with larger practical value to solve cureless epigastric pain Medicine.In order to solve the above technical problems, the present invention uses following technical scheme.

Specific embodiment:

The present invention treats epigastric pain granule prescription by the Chinese medicinal composition of following parts by weight: 20~41 parts of lily, tartarian buckwheat root and rhizome 20~ 41 parts, 3~8 parts of walnut kernel, 4~9 parts of the coptis, 1~5 part of evodia rutaecarpa, 5~14 parts of cuttlebone, 6~15 parts of fritillaria thunbergii, the root of Dahurain angelica 6 ~15 parts, 6~15 parts of Rhizoma Chuanxiong, 4~11 parts of cardamom, 1~4 part of prepared RADIX ET RHIZOMA RHEI, 6~15 parts of dandelion, 1~4 part of radix glycyrrhizae preparata use Medicinal material efficacy effect be respectively.

Tartarian buckwheat root and rhizome: for the root and rhizome of polygonaceae plant tartary buckwheat Fagopyrum tataricum (L.) Gaertn..Have Invigorating the spleen row is stagnant, regulating qi-flowing for relieving pain, the efficacy of removing toxicity for detumescence effect.Cure mainly gastral cavity pain, indigestion.

Walnut kernel: for the drying and ripening and son of juglandaceae plant English walnut Juglans regia L..Walnut kernel, which removes, collaboration Tartarian buckwheat root and rhizome is alleviated outside epigastric pain, the auxiliary gas blood-nourishing effect of Yin Qiganwen, therefore can help tartarian buckwheat root and rhizome protecting the stomach and relieve the pain again.

Lily: this product is liliaceous plant tiger lily Lilium lancifoliumThunb, lily Lilium brownie The dry meat scale leaf of F.E.Brown var.viridulumBaker or Lilium tenuifolium Lilium pumilumDC..Slightly sweet flavor, It is mild-natured, enter taste warp, the heart channel of Hang-Shaoyin, lung channel.There are beneficial spleen and stomach, moistening lung to arrest cough, clearing away the heart fire and tranquillizing, support the effect of the five internal organs.Main perverse trend abdomen Swollen, epigastric pain, and the sharp stool and urine of energy, tonifying middle-Jiao and Qi.

The coptis: for cohosh coptis Coptis chinensis Franch., the triangle leaf coptis Coptisdelioidea C.Y.Cheng et Hsiao or cloud connect the dry rhizome of Coptis teata Wall..Coptis cooperation For tartarian buckwheat root and rhizome to syndrome of liver-stomach heat, disease caused by dampness and heat stasis plays the role of Zhi Genzhiben.

Evodia rutaecarpa: for rutaceae evodia rutaecarpa Evodia rutaecarpa (Juss.) Benth., Shi Hu Evodia Rutaecarpa (Juss.) Benth.var.officinalis (Dode) Huang or thin hair evodia rutaecarpa Evodia The drying almost ripe fruit of rutaecarpa (Juss.) Benth.var.bodinieri (Dode) Huang, evodia rutaecarpa nature and flavor are pungent, The function of bitter, temperature, tool stopping nausea and vomiting by lowering the adverse flow of QI, Wang Ang are said: " hot negative (liver) promoting qi circulation and removing obstruction in the collateral that can enter to faint of evodia rutaecarpa, and hot downlink can be drawn ", Matching with the coptis is Zuojin Wan, there is the function of collaboration to releasing symptom.

Cuttlebone: for Sepiidae animal sepiella maindroni de Rochebrune Sepiella maindroni deRochebrune or golden cuttlefish The drying inner casing of Sepia esculenta Hoyle.Cuttlebone taste is salty, the hemostasis of tepor, Bearberry Extract, hyperacidity and pain relief.

Fritillaria thunbergii: the dry bulb of liliaceous plant fritillaria thunbergii Fritillaria thunbergii Miq..Early summer plant It is excavated when withered, removes impurity, clean, moisturize, cutting sheet, drying.It is bitter in taste, cold.Open strongly fragrant dissipating bind, promoting the dispersing function of the lung heat-clearing, resolving sputum stop Cough.It shares with cuttlebone as Medicinal powder of cuttlefish and firtillary bulb, there are the gastral cavity pain of the liver-stomach disharmony interpretation of the cause, onset and process of an illness, general acid regurgitation water, noisy seemingly famines for treatment.

The root of Dahurain angelica: Angelica dahurica.For the plant of Umbelliferae angelica.It is distributed in northeast and the China of China's Mainland The ground such as north, are grown on 200 meters to 1 of height above sea level, 500 meters of area, be generally born in hayashishita, border, by small stream, shrubbery and mountain valley meadow； Warm-natured, acrid flavour, gas fragrance, slight bitter.Major function: myogenic pain relieving, apocenosis of invigorating blood circulation.

Rhizoma Chuanxiong: Rhizoma Chuanxiong be umbelliferae Rhizoma Chuanxiong Ligusticum chuanxiong Hort dry rhizome, main product in The ground such as Sichuan Province Pengzhou, Dujiang weir are one of Genuine crude drugs in Sichuan, warm-natured, acrid flavour, return liver warp, gallbladder channel, pericardium channel, taste Through.Rhizoma Chuanxiong effect promote breath and open depression, promoting blood circulation and stopping pain, method wind-dryness are wet, and former with controlling, hypochondriac pain abdomen aches, air-cooled headache rotation is dizzy, arthritis muscle contraction.

Cardamom: zingiberaceous plant Amomum cardamomum Amomurn kravanh Pierre ex Gagnep. or amomum compactum Soland ex Maton The dry mature fruit of Amomum compactum Soland ex Maton.Roud cardamon seed pungent-warm enters lung, spleen, the warp of stomach three.White peas or beans Cool benevolence function regulating the flow of QI to ease the stomach, controls the diseases such as epigastric pain abdominal distension, gas gastric disorder causing nausea.

Dandelion: Taraxacum mongolicum Hand.-Mazz, composite family, Dandelion herbaceos perennial.Root Slightly in coniform, bending, 4~10 centimetres long, surface sepia, shrinkage, there is the young pilose antler of brown or yellow-white on root head.Effect is clear Thermal detoxification treats the important drugs of a variety of inflammatory stomach trouble.

Prepared RADIX ET RHIZOMA RHEI: for polygonaceae plant rheum officinale Rheum palmatum L., Rheum tanguticum Maxim Rheumtanguticum The processed product of the drying root and rhizome of Maxim, ex Balf. or Rheum officinale Rheum officinale Baill..Rheum officinale is bitter It is cold rush down under, be usually used in the card of inner reality, use prepared RADIX ET RHIZOMA RHEI, gently to delay its property, it is intended to enter stomach priming downlink, and because of the six hollow viscera must keep its unobstructed, No pain by smooth breath, common cooperation is to gather the function for eliminating pain.

Radix glycyrrhizae preparata: Radix Glycyrrhizae (scientific name: Glycyrrhiza uralensis Fisch) pulse family, Glycyrrhiza perennial herb, root It is sturdy with rhizomes.After honey toast, the property of help enhances.Moxibustion Radix Glycyrrhizae nature and flavor are sweet, flat, return heart, lung, spleen, stomach meridian.With tonifying spleen and Stomach, Yiqi and vein recovery effect.For weakness of the spleen and the stomach, fatigue and weakness, severe palpilation, knotted pulse, the function of coordinating the drug actions of a prescription is had both herein.

Auxiliary material: the auxiliary material of addition is needed in various dosage form manufacturing process.

1. Steviosin: for the mixing glycosides based on Steviosin (C38H60018).

2. starch: caryopsis or euphorbia plant cassava for gramineae plant maize ZeamaysL. ManihotutilissimaPohl. polysaccharide particle obtained in root tuber.

Combination principle:

Medicine compatibility method and theoretical basis of the invention described below.

Up to a hundred published patent documents and national data in literature can be retrieved from patent library searching " epigastric pain " illness The numerous documents in relation to treating epigastric pain illness in thousands of of library it is found that be all utilized mostly in its combination principle and treatment method Traditional theory of traditional Chinese medical science or hospital handed down from one's ancestors solve the technical problem for the treatment of epigastric pain, and theory is almost built upon spleen It is effective to many epigastric pain diseases on the basis of sun, temper and stomach-Yin.But it is clinical also common to have the treatment of part epigastric pain Weary effect or unsatisfactory curative effect, and clinical findings are not within minority.For the epigastric pain illness for controlling weak curative effect, the present invention has been used through this The spleen yin clinical diagnosis and treatment system of creation in inventor more than 30 years constitutes the combination principle theory body based on the deficiency of the spleen-yin theory System's (No. 180 scientific and technical literature publishing houses of one new (Beijing) New Gordon word of TCM Spleen yin theory research soup publish in August, 1992), typing Spleen yin theory (the Chinese medicine basic medical-higher learning of Chinese medicine-teaching material of the present inventor of national Chinese medicine industry higher education teaching material ISBN 978-7-5132-0853-6CIP data core word (2012) the 069482nd), constitute under spleen yin theoretical direction taste simultaneously Disease is with taste with the combination principle and its theoretical system controlled.

For formula of the invention for the special interpretation of the cause, onset and process of an illness of the clinical disease of spleen yin, according to the deficiency of spleen-YIN deficiency of Yin, gas is weak, causes just Empty heresy is invaded, actual situation mutually and, along internal organs mutually thus disease and stomach internal organs or stomach internal organs lesion fu-viscera disease involving zang-viscera, form related multidimensional data relationship Confused, difficulty divides cause and effect, and variable mixes, and multiple cause and effect leads to the multifactor disease result of cause and effect hard to say.The present invention is for each Epigastric pain caused by kind factor is faced card thinking in line with " searching for the primary cause of disease in treatment, this is in primary and giving consideration to both the incidental and fundamental ", is createed for refractory The taste of property epigastric pain are simultaneous to be controlled, the tcm prescription of special effect.

The present invention is mutually made by based on lily, tartarian buckwheat root and rhizome, walnut kernel, being equipped with the mutually auxiliary phase assistant of other flavour of a drug, and it is complete to form compatibility Cooperate with rigorous principle-method-recipe-medicines.Tartarian buckwheat root and rhizome slight bitter is slightly cold in side, invigorating the spleen, stagnant, the regulating qi-flowing for relieving pain of row, removing toxicity for detumescence, the sweet temperature of walnut kernel Auxiliary gas blood-nourishing, stomach function regulating, ease constipation, warm lung, kidney tonifying, after the two is harmonious, temperature of trembling with fear compatibility turns flat, and hardship profit is harmonious and taste becomes sweet light, No longer it is the addition of physics and the qualitative change of chemical new life has occurred, is subject to lily benefit spleen, stomach function regulating, moistening lung, analgesic, the function for supporting the five internal organs Effect closes and forms beneficial spleen and stomach, the gas yin people having the same aspiration and interest, actual situation and the epigastric pain controlled taken on an entirely new look with unit medicament script effect and examine Control special thinking.After assistant makes other flavour of a drug, compatibility is more complete rigorous, to gastric and duodenal ulcer, acute or chronic gastritis with rotten Rotten, gastritis belongs to yin deficiency of spleen and stomach, yin deficiency with gastral cavity pain caused by the difficult severe such as bile reflux etc. or even part gastric cancer, disease Gas is weak, and actual situation is alternate, hair tonic syndrome of liver-stomach heat, moisture stasis blocking symptoms include duration gastral cavilty (or and side of body rib) pain, noisy, pantothenic acid, Gas, happiness is pressed or tenderness person, and the intractable epigastric pain not recovered for a long time is caused especially for many reasons, has unexpected treatment Effect, three tastes main ingredient with their own characteristics combine together through the chemical combination collaboration of rigorous compatibility, and formed main ingredient characterized by integrally and It is the monarch of monarch with one, completes a kind of innovating on the basis of succession again, clinical implementation hundred is tested with hundred, becomes this hair One of the technical characteristics of bright formula.

To form Pharmaceutical Analysis: inventive formulation pharmic function is dredged based on the slightly cold removing toxic substances of slight bitter, relieving haperacidity myogenic with pungent-warm Liver, qi-regulating open it is strongly fragrant supplemented by.Tartarian buckwheat root and rhizome is clearing heat and detoxicating in inventive formulation, activates blood circulation and disperses blood clots, and walnut kernel cooperates tartarian buckwheat root and rhizome strongly fragrant to liver stomach Disease caused by heat, dampness and heat stasis plays the role of Zhi Genzhiben.However cuttlebone astringing to arrest bleeding, hyperacidity and pain relief, fritillaria thunbergii heat-clearing Dissipating bind resolving sputum, as auxiliary, first three taste medical instrument has the effect of relieving haperacidity hemostasis and pain-relieving for the two combination, but assists first three taste as ministerial drug Its control effect and mechanism has the variation of matter after main ingredient, and effectiveness increases suddenly, generates more times of effect.Though there is publication number The documents such as CN200310115980, CN200710018234 apply cuttlebone and fritillaria thunbergii has shared astringing to arrest bleeding, relieving haperacidity stops Bitterly, heat-clearing mass-dissipating efficacy, but the present invention is a difference in that the two respectively with first three taste main ingredient and rear adjuvant taste compatibility, is played Ministerial drug assisted ability promotes first three taste main ingredient and rear adjuvant taste complete fusion, enables the invention to the gastral cavilty for the deficiency of the spleen-yin disease Pain generates unexpected therapeutic effect, in view of the control effect and mechanism that basic theory is different and has, produces two in other documents Person is combined different effects, is the innovation to the prior art, creates unexpected significant curative effect, is novelty of the present invention One of embodiment and technical characteristics.

Evodia rutaecarpa, two medicine of the root of Dahurain angelica are the product of pungent-warm, are the assistant of main ingredient, and fever and chills are mutually simultaneous, using warming and heat-clearing simultaneously, the bitter drop of pungent liter, pungent It dissipates hot and suffocating, also enhances drop check and spit the effect of relieving haperacidity, effect helps the elevating function for restoring transporting and transforming function of the spleen and stomach.Prepared RADIX ET RHIZOMA RHEI is processed sweet Careless two medicines share, and mediate in preceding master, medicine is made to be allowed to middle coke, play dredging stomach and intestine, lead to without pain, and guiding action.The complete beneficial spleen in side Control stomach, actual situation with control, attack it is evil do not hurt just, righting and attack heresy, highlight Chinese medicine and cure the disease and stay people, people-oriented feature, and it is existing Technology is compared, the beneficial effects of the present invention are: to the epigastric pain that a variety of epigastric pains especially chronic and refractory deficiency of Yin does not recover for a long time, With unique curative effect.

The 13 ingenious prescriptions of taste Chinese herbal medicine of the invention, reasonable compatibility, drug mutually make compatibility, and main ingredient function can be improved in adjuvant Effect；Mutual reinforcement between compatibility improves performance effects and curative effect of medication；Mutual restraint between two drugs compatibility makes its poisonous side effect of medicine mitigate or disappear.Drug phase Mutual coordinative role plays the special efficacy of beneficial spleen and stomach, analgesic of having a respite altogether.Walnut kernel especially of the invention is during medicine is eaten and used simply Medicine can protect nitrogen oxide and protective tissue mucous membrane, get instant result with the generation of tartarian buckwheat root and rhizome compatibility containing antioxidant and alpha-linolenic acid Fusion, be conducive to the performance of tartarian buckwheat root and rhizome analgesic effect, and obtain the tired tired invaluable experience tested through creative work practice, It is that the present invention takes one of the one of key factor of effect and technical characteristics.Therefore, we have filled up the intractable stomach in part One blank of gastral cavity pain special efficacy recipe.

Preparation process:

The present invention treats the preparation method of epigastric pain granule and process includes the following steps:

The processing and processing of medicinal material:

Lily: removing impurity, and well sifted ash bits are fried with slow fire yellowish, when tack-free, taking-up is cooled down；

Tartarian buckwheat root and rhizome: clean slice dries；

Walnut kernel: removing the peel point, removes the wooden diaphragm of impurity and separation, stores in drying receptacle, sets at shady and cool drying；

The coptis: except impurity is gone out, rear shave is moisturized, is dried, the used time smashs to pieces；

Evodia rutaecarpa: except impurity is gone out, clean slice dries；

Cuttlebone: except impurity is gone out, clean dry pounds into fritter；

Fritillaria thunbergii: cutting is cleaned, and is moisturized, is cut sheet, dry；Used time breaks into fragment；

The root of Dahurain angelica: removing impurity, separates size, slightly soaks, moisturize, cut sheet, dry；

Rhizoma Chuanxiong: removing impurity, separates size, slightly steeps, and cleans, moisturizes, shave, dry；

Cardamom: impurity is removed.Used time smashs to pieces；

Prepared RADIX ET RHIZOMA RHEI: according to wine stew or wine steam method stew or steam to it is inside and outside be in black；

Dandelion: removing impurity, cleans, dissection, dry；

Radix glycyrrhizae preparata: it fries according to bake with honey to yellow to buff, takes out, cool down when tack-free.

Above-mentioned medicinal material is processed by pharmacopeia (annex) kind and is executed under item, and supplementary material specification quality standard and inspection method are answered Meet China's coastal port one regulation.

The preparation method and process of granule include the following steps:

(1) fritillaria thunbergii of whole prescription parts by weight is taken all to crush, medicinal powder is 80~100 mesh after crushing, spare；

(2) the lily tartarian buckwheat root and rhizome, walnut kernel, the coptis, evodia rutaecarpa, cuttlebone crushing for taking half prescription parts by weight, after crushing Medicinal powder is 80~100 mesh, spare；

(3) traditional Chinese medicinal components crushed to above-mentioned steps (1), step (2) carry out medicinal powder and crush receipts powder rate detection, and average medicinal powder receives powder Rate is 80%~95%；

(4) by the lily tartarian buckwheat root and rhizome of remaining half prescription parts by weight, walnut kernel, the coptis, evodia rutaecarpa, cuttlebone and it is other not After the full prescription parts by weight drug mixing crushed plus clear water is standing and soaking 15~30 points of kinds；

(5) drug after impregnating step (4) carries out filtering out preparation decoction；

(6) 2~4 times of clear water that step (5) drug total amount is added are decocted for the first time, 20~30 points of kinds are decocted after boiling, extract medical fluid out It is spare；3~5 times of clear water of step (5) drug total amount are added in second of decoction, and 30~40 points of kinds are decocted after boiling, and extraction medical fluid is standby With；Third time decocts 4~6 times of clear water that step (5) drug total amount is added, and 40~50 points of kinds are decocted after boiling, and extraction medical fluid is spare；

(7) by (6) first, second and third extraction liquid medicine mixings of step, 3~6 hours are stood；

(8) concentration will be evacuated to after step (7) medical filtration to fill, filtrate is concentrated into the clear cream that relative density is 1.3~1.5；

(9) by above-mentioned steps (1), step (2), medicinal powder and clear cream obtained by step (8) be added medicinal powder and clear cream total amount 0.5~ 1.5% Steviosin, 5~15% starch that medicinal powder and clear cream total amount is added, then mix；

(10) granulator molding, shaped granule drying is added in the spice after mixing step (9), and drying temperature is 75~90 DEG C；

(11) drying particle enters packing machine and is packaged into each taking pouch, and every bag can be packaged as 5~10 grams.

The preparation process of above-mentioned treatment epigastric pain granule must meet quality management system " quality control of pharmaceutical production rule Model " (GoodManufacturePracticeofMedicalProducts) standard and quality requirement.

The present invention is according to claim 1 to the dosage form of the Chinese materia medica preparation of the treatment epigastric pain formula of any one described in 5 By " pharmaceutical production quality management practices " of quality management system be made decoction, pill, capsule, tablet, powder, oral solution or Other dosage forms.

Quality standard:

Quality standard is to control the foundation of product quality.It must be in strict accordance with " one annex regulation of Chinese Pharmacopoeia 2005 version is wanted It asks, the Chinese materia medica preparation for the treatment of epigastric pain is detected from all items such as preparation method, identification, inspection.Micro- mirror is used in identifying item Other method, thin-layered chromatography are respectively to the lily, tartarian buckwheat root and rhizome, walnut kernel, the coptis, evodia rutaecarpa, cuttlebone, fritillaria thunbergii, white in prescription The root of Dahurian angelica, Rhizoma Chuanxiong, cardamom, prepared RADIX ET RHIZOMA RHEI, dandelion, radix glycyrrhizae preparata are identified, and are compareed with reference substance and negative sample；It is checking Under, three batches of 9 samples need to be all taken respectively to examine to granularity, moisture, melting, content uniformity and limit test of microbe It surveys, testing result is all in limits.Under limit test of microbe item, methodology validation is carried out.

Patent medicine identifies:

Using the content of Berberine hydrochloride in high effective liquid chromatography for measuring treatment epigastric pain granule.

(1) instrument and reagent: U.S.'s Agilent1100 liquid chromatograph；Treatment epigastric pain granule of the invention；Hydrochloric acid Jamaicin reference substance (Chinese pharmaceutical biological product identifies institute, 110713-200208).

(2) chromatographic condition: chromatographic column: 4 μm of Diamonsil C18 (250 × 4.6mm)；Mobile phase: second is fine- (2.0) 29:71 is with phosphoric acid regulating ph value to 0.033mol/l potassium dihydrogen phosphate；Flow velocity: 1mLmin-1；Detection wavelength: For 370nm.

(3) preparation of reference substance solution: precision is weighed in 100 DEG C of dry 5 hours Berberine hydrochloride reference substances, adds flowing Solution of every 1ml containing 0.1mg is mutually made.

(4) range of linearity is tested: precision weighs Berberine hydrochloride reference substance 15.0mg, sets in 15ml measuring bottle, adds 1% hydrochloric acid Methanol makes to dissolve and be diluted to scale, and precision measures 0.05ml, 0.1ml, 0.2ml, 0.4ml, 0.8ml, sets 10ml measuring bottle respectively In, add 1% hydrochloric acid methanol to scale, shakes up, filter, 10 μ l of subsequent filtrate is taken to inject liquid chromatograph, measurement, with integrating peak areas For ordinate (Y), Berberine hydrochloride solution concentration is abscissa (X), acquires regression equation are as follows: Y=5x10- 5X-0.5225, r =0.9999, conclusion shows: Berberine hydrochloride solution concentration sample introduction within the scope of 5.0~80.0 μ g/ml, peak area and opposite Answer solution concentration in good linear relationship.

(5) this product 10g is taken, it is finely ground, add methanol 50ml, set and be heated to reflux in water-bath 1 hour, let cool, filters, filtrate conduct Test solution.Control medicinal material 0.4g separately is taken, adds methanol 20ml, is made in the same way of control medicinal material solution.According to thin-layered chromatography (" in State's pharmacopeia " 2005 years one VI B of annex of version) test, 5 μ l of test solution, 2 μ l of control medicinal material solution are drawn, point is dry same respectively On one silica gel g thin-layer plate, with benzene-acetate-methanol-isopropanol -- strong ammonia solution (12:6:3:3:1) is solvent, sets ammonia In the chromatography cylinder of saturated with vapor, it is unfolded, takes out, dry, set and inspected under ultraviolet lamp (365nm).In sample chromatogram, with it is right According on the corresponding position of medicinal material chromatography, identical yellow fluorescence spot is shown.Patent medicine should meet related items under corresponding dosage form item It provides (one annex of China's coastal port).

(6) take this product, set microscopically observation: 1~6 cell of nonglandular hair, straight or bending, wall end joint is expanded. Calcium oxalate cluster crystal 20~86um of diameter, the sharp point of corner angle.Needle-like calcium oxalate crystal is tiny, 10~32 μm long, is irregularly filled in thin-walled In cell.18~58 μm of epidermis chrotoplast diameter of kind, it is in bar shaped that surface, which is seen,.

Stability experiment:

According to " two annex of Chinese Pharmacopoeia 2005 version " medicine stability test guideline ", in combined treatment epigastric pain The characteristics of medicine preparation, accelerate stability inspection item being determined as appearance type shape, thin-layer chromatography reflects in long term test Not, water content inspection, limit test of microbe detect the stability of this preparation variety with this inspection item result.

1, influence factor is tested: medical polypropylene composite film packaging is used, at temperature (60 DEG C), humidity (90% ± 5%, 25 DEG C), it places 10 days under conditions of strong light (5000I ×), and investigated respectively at 5 days, sampling in 10 days.Influence factor test knot Fruit: this product is except its type shape, chromatographic identification, water after placing 10 days in the case of temperature (60 DEG C), humidity (95% ± 5%, 25 DEG C) Divide, microbial limit meets regulation, stable product quality.

2, accelerated test: using medical polypropylene composite film packaging, at temperature (40 DEG C ± 2 DEG C), humidity (75% ± 5%) it places 6 months under conditions of, is investigated respectively at sampling in 0,1,2,3,6 month.As a result: accelerated test 6 months, sample Type shape, chromatographic identification, moisture, microbial limit meet regulation, stable product quality.

3, keep sample test for a long time: using medical polypropylene composite film packaging, at temperature (25 DEG C ± 2 DEG C), humidity (60% ± 10%) it is placed under conditions of.It is investigated respectively at sampling in 0,3,6,12 month.As a result: through long term test 12 months the result shows that, Type shape, chromatographic identification, moisture, microbial limit meet regulation, stable product quality.

Stability test result is；It is investigated by 6 months accelerated tests, indices are basically unchanged.Long term test 12 Show that indices are without significant change within a month.According to accelerated test and long-term stable experiment as a result, will tentatively be set to validity period 12 months.

Anxious poison experiment:

Treatment epigastric pain granular preparation of the invention is administered to intragastric administration on mice, observes 7 days, to LD50 > 25.0g/kg of mouse, is 90 times (adult clinic recommended dose 0.25g/kg) of clinical recommended dose, for mouse with 45.0g/kg, volume is 30ml/kg filling Stomach, freely, appearance activity is reduced after 12 hours for test mice activity after administration, all real without 1 dead mouse after 12 hours It tests mouse hair and is close to body, glossy, diet, excrement and other situations are without exception.Animal subject weight has increase after 7 days. According to clinical observation result and anxious malicious experimental result, it was demonstrated that the drug quality is safe.

Treatment method: usage and dosage.

(1) the content of dispersion criterion calculation that granule is detected by molding inner wrapping；Three times a day, it is taken every time by conditions The patent medicine that 1~5 gram of content of dispersion.

(2) avoid the greasy object of good fortune chili oil, avoid tobacco and wine；Pregnant woman is used with caution.

Example scheme:

The present embodiment uses the epigastric pain patient that different parts by weight formulas is suitable for not symptom.

Embodiment 1: a kind of granule for treating epigastric pain is made of the traditional Chinese medicinal components of following parts by weight: 39 parts of lily, hardship 38 parts of chinese bulbous onion, 6 parts of walnut kernel, 7 parts of the coptis, 3 parts of evodia rutaecarpa, 12 parts of cuttlebone, 13 parts of fritillaria thunbergii, 13 parts of the root of Dahurain angelica, Rhizoma Chuanxiong 13 Part, 9 parts of cardamom, 3 parts of prepared RADIX ET RHIZOMA RHEI, 13 parts of dandelion, 3 parts of radix glycyrrhizae preparata.

The preparation method and processing step that embodiment 1 treats epigastric pain granule are the same as aforementioned " preparation process ".

Embodiment 2: a kind of granule for treating epigastric pain is made of the traditional Chinese medicinal components of following parts by weight: 22 parts of lily, hardship 19 parts of chinese bulbous onion, 4 parts of walnut kernel, 5 parts of the coptis, 1 part of evodia rutaecarpa, 5 parts of cuttlebone, 7 parts of fritillaria thunbergii, 6 parts of the root of Dahurain angelica, 8 parts of Rhizoma Chuanxiong, cardamom 5 parts, 1 part of prepared RADIX ET RHIZOMA RHEI, 6 parts of dandelion, 1 part of radix glycyrrhizae preparata.

The preparation method and processing step that embodiment 2 treats gastral cavity pain granule are the same as aforementioned " preparation process ".

Embodiment 3: a kind of granule for treating epigastric pain is made of the traditional Chinese medicinal components of following parts by weight: 28 parts of lily, hardship 30 parts of chinese bulbous onion, 4 parts of walnut kernel, 6 parts of the coptis, 3 parts of evodia rutaecarpa, 8 parts of cuttlebone, 11 parts of fritillaria thunbergii, 9 parts of the root of Dahurain angelica, 12 parts of Rhizoma Chuanxiong, 6 parts of cardamom, 3 parts of prepared RADIX ET RHIZOMA RHEI, 9 parts of dandelion, 2 parts of radix glycyrrhizae preparata.

The preparation method and processing step that embodiment 3 treats gastral cavity pain granule are the same as aforementioned " preparation process ".

Efficacy assessment standard:

Evaluation criteria uses four kinds of efficacy results.

Cure: gastral cavilty pain symptom disappear, appetite enhancing, stomach is unobstructed, no gastral cavilty pain symptom, more after do not recur.

Effective: gastral cavilty pain symptom is obviously improved, and appetite enhancing, stomach is unobstructed, and gastral cavilty pain symptom is relieved.

Effective: gastral cavilty pain symptom improves, and has appetite, stomach is more unobstructed, and gastral cavilty pain symptom is alleviated.

Invalid: gastral cavilty pain symptom is without improvement, without significant change before gastral cavilty pain symptom and medication.

Observation of curative effect:

Observation of curative effect uses common SANJIU WEITAI KELI and compares.

Compared with prior art, generated beneficial effect is treatment epigastric pain granule of the invention: invention formulation (being formulated using previous embodiment 3) is compared observation with the curative effect of SANJIU WEITAI KELI treatment epigastric pain.Method: it will be collected into 364 epigastric pain patients be randomly divided into treatment group and control group, treatment group 200 takes orally granule of the present invention (adult one Day three times, each 5g, 7~10 days as one therapeutic course)；Control group 164, oral SANJIU WEITAI KELI (abides by its product description clothes Method), observe the treatment results situation of epigastric pain patient；

It is as a result as follows after 1-2 course of therapy:

Two groups of total effective rates for the treatment of and control are respectively 92.4% and 73.2%, be statistically analyzed significant difference (P < 0.01).Conclusion: the present invention, which treats epigastric pain patient, significant curative effect.It is clinical it is nearly more than 30 years in use, not yet sending out up to now Existing an example is due to taking apparent serious adverse reaction caused by epigastric pain granule of the present invention, it was demonstrated that in epigastric pain of the present invention Medicine preparation is safe and effective when regular dose treatment is taken, and toxic side effect is low.In long-term, high-dose is taken, no malaise symptoms, Nausea or diarrhea etc..

1, the present invention is pure Chinese medicinal preparation, and generated beneficial effect is: various medicinal material compatibilities bring out the best in each other, and has cold dispelling Eliminating dampness, liver-smoothing, qi-regulating, in promoting the circulation of qi tune, warming middle-JIAO and strengthening the spleen the effect of, the parameter of formula is increased and decreased for all kinds of epigastric pain illnesss Adjustment, to be suitable for epigastric pain illness caused by the symptoms such as acute chronic gastroenteritis, gastric ulcer, gastrorrhagia, stomachache, nausea and vomiting.

2, good effect of the present invention, toxic side effect are small, securely and reliably, can be used for a long time, preparation method is scientific and reasonable.

Clinical case:

Clinical case is the sufferer in recent years randomly selected.

Case 1: Liu XX, female, 50 years old, Sichuan Province Leshan people from Muchuan County.Before have stomach trouble history for many years, aggravate breaking-out January. Patient's epigastric pain, nausea and vomiting, lassitude, abdominal distension, when with low-heat.Used a variety of drug therapies, poor effect.It is situated between through friend It continues to examine, checks as erosive gastritis with duodenal ulcer.After taking Chinese materia medica preparation January of the present invention, symptom disappears substantially. Treatment January is continued to strengthen, symptom all disappears, and check turns superficial gastritis.Thereafter health.On November 3rd, 2018 with It visits: without recurrence, sighing with deep feeling and say within 10 years: " not seeing a doctor within 10 years, one keeps an eye on 10 years ".

Case 2: Liao XX, male, 53 years old, Sichuan Province people from Chengdu.Patient has a stomach-ache, gasteremphraxis, there is nausea, hiccup, gas of choking, appetite Depressed, burnout day is thin.A variety of drug therapies, curative effect is not good enough between 30 years, and there is breaking-out in when pain, and painful pole is very.Come through friend's introduction It examines, is diagnosed as gastric ulcer, epigastric pain, take Chinese materia medica preparation of the present invention, after continuous two months, have a stomach-ache, gasteremphraxis symptom significantly mitigates, After continuing to strengthen January, 30 years ailing suddenly health, not only pain is eliminated, and stomach functional rehabilitation is normal, and check ulcer is cured completely, It can be drunk unexpectedly later such as ordinary person, enable companions surprised endlessly.Follow-up on November 4 in 2018: 5 years so far without recurrence.

Case 3: Chu X, male, Alibaba vice president.First visit on April 1 in 2018.Patient suffers from epigastric pain 2 years, takes excessive Kind drug therapy, unsatisfactory curative effect, special trip is out of admiration for a famous person to examine.After taking Chinese materia medica preparation half a month of the present invention (1 course for the treatment of), stomachache is obvious good Turn, continue to take Chinese materia medica preparation half a month of the present invention, stomachache disappears, and follow-up is without recurrence after half a year.

4: ten thousand X of case, male, 34 years old, peasant.Epigastric pain is with receiving poor anorexia, more misery sour waters in mouth, fatigue and weakness, and body is cold Anemophobia, gynecological ailments are often had a dizzy spell.Excessive family's hospital admission is removed, used a variety of methods to treat, and did not improved.Through friend People introduces to examine, and is diagnosed as epigastric pain, consumptive disease, takes Chinese materia medica preparation of the present invention after half a month, above-mentioned symptom is substantially reduced, continues to take It is all disappeared with symptom after 1 month, follow-up is not recurred after March.

Treatment results:

The statistics for the treatment of results has taken the nearly 2 years part statistical data for curing patient.

Patient nearly 100,000 are cured over 30 years, 6253 accepted for medical treatment according to, 2 years 2018 statistics parts in 2017 Example patient calculates, and through two course of therapy, wherein curing 4207, effective 1216, effective 562, invalid 268, always has Efficiency is up to 95.7%.

The above description is merely a specific embodiment, but scope of protection of the present invention is not limited thereto, any The change or replacement expected without creative work, should be covered by the protection scope of the present invention.

Claims

1. a kind of formula for treating epigastric pain granule, which is characterized in that be by lily, tartarian buckwheat root and rhizome, walnut kernel, the coptis, Wu Zhu Cornel, cuttlebone, fritillaria thunbergii, the root of Dahurain angelica, Rhizoma Chuanxiong, cardamom, prepared RADIX ET RHIZOMA RHEI, dandelion, 13 kinds of Chinese medicinal compositions of radix glycyrrhizae preparata Chinese medicine composition, It is made of the traditional Chinese medicinal components of following parts by weight；20~41 parts of lily, 20~41 parts of tartarian buckwheat root and rhizome, 3~8 parts of walnut kernel, the coptis 4~9 Part, 1~5 part of evodia rutaecarpa, 5~14 parts of cuttlebone, 6~15 parts of fritillaria thunbergii, 6~15 parts of the root of Dahurain angelica, 6~15 parts of Rhizoma Chuanxiong, cardamom 4~11 Part, 1~4 part of prepared RADIX ET RHIZOMA RHEI, 6~15 parts of dandelion, 1~4 part of radix glycyrrhizae preparata.

2. a kind of formula for treating epigastric pain granule according to claim 1, it is further characterized in that, by following parts by weight Traditional Chinese medicinal components composition；25~35 parts of lily, 25~35 parts of tartarian buckwheat root and rhizome, 4~6 parts of walnut kernel, 5~7 parts of the coptis, evodia rutaecarpa 1~3 Part, 7~11 parts of cuttlebone, 8~12 parts of fritillaria thunbergii, 8~12 parts of the root of Dahurain angelica, 7~12 parts of Rhizoma Chuanxiong, 5~9 parts of cardamom, prepared RADIX ET RHIZOMA RHEI 2~3 Part, 8~12 parts of dandelion, 1~3 part of radix glycyrrhizae preparata.

3. a kind of formula for treating epigastric pain granule according to claim 1, it is further characterized in that, by following parts by weight Traditional Chinese medicinal components composition；38 parts of lily, 39 parts of tartarian buckwheat root and rhizome, 6 parts of walnut kernel, 7 parts of the coptis, 3 parts of evodia rutaecarpa, 12 parts of cuttlebone, Zhejiang 13 parts of fritillaria, 13 parts of the root of Dahurain angelica, 13 parts of Rhizoma Chuanxiong, 9 parts of cardamom, 3 parts of prepared RADIX ET RHIZOMA RHEI, 13 parts of dandelion, 3 parts of radix glycyrrhizae preparata.

4. a kind of formula for treating epigastric pain granule according to claim 1, it is further characterized in that, by following parts by weight Traditional Chinese medicinal components composition；22 parts of lily, 24 parts of tartarian buckwheat root and rhizome, 4 parts of walnut kernel, 5 parts of the coptis, 2 parts of evodia rutaecarpa, 6 parts of cuttlebone, bulb of thunberg fritillary Female 7 parts, 7 parts of the root of Dahurain angelica, 8 parts of Rhizoma Chuanxiong, 6 parts of cardamom, 2 parts of prepared RADIX ET RHIZOMA RHEI, 7 parts of dandelion, 2 parts of radix glycyrrhizae preparata.

5. a kind of formula for treating epigastric pain granule according to claim 1, it is further characterized in that, by following parts by weight Traditional Chinese medicinal components composition: 30 parts of lily, 32 parts of tartarian buckwheat root and rhizome, 5 parts of walnut kernel, 6 parts of the coptis, 2 parts of evodia rutaecarpa, 9 parts of cuttlebone, bulb of thunberg fritillary Female 10 parts, 10 parts of the root of Dahurain angelica, 10 parts of Rhizoma Chuanxiong, 7 parts of cardamom, 2 parts of prepared RADIX ET RHIZOMA RHEI, 10 parts of dandelion, 2 parts of radix glycyrrhizae preparata.

6. a kind of formula for treating epigastric pain granule according to claim 1, it is further characterized in that, claim 1 institute The main ingredient of compatibility in a kind of formula for treating epigastric pain granule stated are as follows: lily, tartarian buckwheat root and rhizome, walnut kernel.

7. a kind of preparation method for treating epigastric pain granule, which is characterized in that this method be by lily, tartarian buckwheat root and rhizome, walnut kernel, The coptis, evodia rutaecarpa, cuttlebone, fritillaria thunbergii, the root of Dahurain angelica, Rhizoma Chuanxiong, cardamom, prepared RADIX ET RHIZOMA RHEI, dandelion, 13 kinds of Chinese medicinal compositions of radix glycyrrhizae preparata and by The traditional Chinese medicinal components of following parts by weight are made；20~41 parts of lily, 20~41 parts of tartarian buckwheat root and rhizome, 3~8 parts of walnut kernel, 4~9 parts of the coptis, 1~5 part of evodia rutaecarpa, 5~14 parts of cuttlebone, 6~15 parts of fritillaria thunbergii, 6~15 parts of the root of Dahurain angelica, 6~15 parts of Rhizoma Chuanxiong, 4~11 parts of cardamom, 1~4 part of prepared RADIX ET RHIZOMA RHEI, 6~15 parts of dandelion, 1~4 part of radix glycyrrhizae preparata；The step of granule is made is as follows；

Step (1): the fritillaria thunbergii of whole prescription parts by weight is taken all to crush, medicinal powder is spare after crushing；

Step (2): taking the lily tartarian buckwheat root and rhizome, walnut kernel, the coptis, evodia rutaecarpa, cuttlebone crushing of half prescription parts by weight, Medicinal powder is spare after crushing；

Step (3): medicinal powder receives the detection of powder rate after crushing to the traditional Chinese medicinal components that above-mentioned steps (1), step (2) crush；

Step (4): by the lily tartarian buckwheat root and rhizome of remaining half prescription parts by weight, walnut kernel, the coptis, evodia rutaecarpa, cuttlebone with After other full prescription parts by weight drug mixing not crushed plus clear water is standing and soaking 15~30 points of kinds；

Step (5): the drug after step (4) are impregnated carries out filtering out preparation decoction；

Step (6): decocting 2~4 times of clear water that step (5) drug total amount is added for the first time, and 20~30 points of kinds, extraction are decocted after boiling Medical fluid is spare；3~5 times of clear water of step (5) drug total amount are added in second of decoction, and 30~40 points of kinds are decocted after boiling, extract medicine out Liquid is spare；Third time decocts 4~6 times of clear water that step (5) drug total amount is added, and 40~50 points of kinds are decocted after boiling, extracts medical fluid out It is spare；

Step (7): by (6) first, second and third extraction liquid medicine mixings of step, 3~6 hours are stood；

Step (8): concentration is evacuated to after medical filtration after mixing, standing and is filled, filtrate is concentrated into clear cream；

Step (9): Steviosin and starch is added in medicinal powder obtained by above-mentioned steps (1), step (2), step (8) and clear cream, then It mixes；

Step (10): granulator molding, shaped granule drying is added in the spice after step (9) are mixed；

Step (11): drying particle enters packing machine and is packaged into each taking pouch, and every bag can be packaged as 5~10 grams.

8. a kind of preparation method for treating epigastric pain granule according to claim 7, it is further characterized in that；

It (1) is 80~100 mesh after medicinal powder described in step (1) crushes in claim 7；

It (2) is 80~100 mesh after medicinal powder described in step (2) crushes in claim 7；

(3) it is 80%~95% that average medicinal powder described in step (3), which receives powder rate, in claim 7；

(4) relative density of clear cream is 1.3~1.5 after being concentrated described in step (8) in claim 7；

(5) Steviosin of addition described in step (9) is the 0.5~1.5% of medicinal powder and clear cream total amount in claim 7；

(6) starch of addition described in step (9) is the 5~15% of medicinal powder and clear cream total amount in claim 7；

(7) drying temperature of particle described in step (10) is 75~90 DEG C in claim 7.