CN109157632B

CN109157632B - Formula and preparation method of granules for treating epigastric pain

Info

Publication number: CN109157632B
Application number: CN201811357557.5A
Authority: CN
Inventors: 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: 2021-09-14
Anticipated expiration: 2038-11-15
Also published as: CN109157632A

Abstract

The invention discloses a formula of granules for treating epigastric pain and a preparation method thereof, belongs to the technical field of traditional Chinese medicine formula preparations, and provides a special traditional Chinese medicine preparation for treating epigastric pain and a preparation method thereof aiming at the problem that in the prior art, the epigastric pain caused by various chronic stomach diseases such as peptic ulcer, non-atrophic gastritis, functional dyspepsia, atrophic gastritis, erosive gastritis and the like can not be cured for a long time. The traditional Chinese medicine composition disclosed by the invention has an obvious curative effect on epigastric pain, in particular epigastric pain which cannot be cured for a long time by a conventional method. The selected medicinal materials are easy to obtain, good in safety, free of any toxic or side effect, low in cost and not easy to relapse after the epigastric pain is cured, and the Chinese medicinal composition is worthy of wide clinical popularization and application.

Description

Formula and preparation method of granules for treating epigastric pain

Technical Field

The invention relates to a formula of granules for treating epigastric pain and a preparation method thereof, belongs to the technical field of traditional Chinese medicine formula preparations, and aims to provide a traditional Chinese medicine formula preparation for treating epigastric pain.

Background

Gastropathy is the most widespread disease in the world, and epigastric pain is the most common symptom in gastropathy. According to the world health organization, the number of people who die of gastrointestinal diseases every year in the world is more than 6000 million, acute or chronic gastric diseases including peptic ulcer, non-atrophic gastritis, functional dyspepsia, and other more serious gastric diseases occur almost to different degrees in the whole life of people, and any type of gastric disease is accompanied by different types of epigastric pain, and may relapse at any time after healing. With the acceleration of modern life rhythm and the change of dietary conditions, the incidence rate of epigastric pain is higher than the joint and even higher than the first symptoms of all visceral diseases. How to treat epigastric pain symptoms caused by various factors becomes an important subject for the medical interface.

In order to further develop the medicine for treating epigastric pain, the inventor develops the theory of spleen yin science through clinical research and experience accumulation in nearly thirty years, provides a series of academic findings that spleen yin is the basis of acquired basis, spleen yin pathological changes have deficiency and excess, and the like, discloses the internal storage mechanism and the clinical characteristics of spleen yin deficiency symptoms and excess symptoms in various diseases from a unique visual angle, removes blind areas, theoretical forbidden areas and clinical error areas of predecessors on spleen yin cognition, provides and practices the nature and taste of spleen-nourishing medicines for the first time, demonstrates the difference of spleen yin deficiency and stomach yin deficiency symptoms, establishes the diagnosis standard, the prescription selection medication standard and the curative effect judgment standard of spleen yin deficiency symptoms and excess symptoms, establishes a set of complete spleen yin clinical diagnosis and treatment system, and creates a unique formula thought of 'granule' for treating epigastric pain, and a specific preparation method thereof through a series of addition, subtraction and addition, the invention solves the technical problems of treating spleen and stomach diseases, spleen diseases, stomach or stomach diseases, and stomach pain which is caused by spleen or stomach diseases and even unhealed long-term illness by creative labor.

Disclosure of Invention

The invention provides a formula and a preparation method of a granule for treating epigastric pain, aiming at solving the problem that the epigastric pain caused by complication of spleen and stomach, splenopathy, stomach or stomach illness and spleen can not be cured in various chronic stomach diseases such as peptic ulcer, non-atrophic gastritis, functional dyspepsia, atrophic gastritis, erosive gastritis and the like in the prior art, and taking the theory of deficiency of spleen-yin as guidance, and the granule is used for treating epigastric pain with the symptoms of abdominal fullness and distention, anorexia, fatigue, hypodynamia, dry stool and the like. The granules adopt a high-quality traditional Chinese medicine formula, have the effects of harmonizing stomach and benefiting yin, detoxifying and removing blood stasis, and regulating qi to alleviate pain, are beneficial to the perfection of the functions of the digestive system, and can also enhance the body resistance and improve the body immunity function, thereby achieving the effect of treating both principal and secondary aspect of disease, having obvious curative effect on treating epigastric pain, and providing a clinical prescription with higher practical value for solving the problem of intractable epigastric pain. In order to solve the technical problems, the invention adopts the following technical scheme.

The specific implementation mode is as follows:

the granular formulation for treating epigastric pain of the invention comprises the following traditional Chinese medicines in parts by weight: 20-41 parts of lily, 20-41 parts of tartary buckwheat, 3-8 parts of walnut kernel, 4-9 parts of coptis chinensis, 1-5 parts of evodia rutaecarpa, 5-14 parts of cuttlebone, 6-15 parts of thunberg fritillary bulb, 6-15 parts of angelica dahurica, 6-15 parts of ligusticum wallichii, 4-11 parts of cardamom, 1-4 parts of cooked rhubarb, 6-15 parts of dandelion and 1-4 parts of honey-fried licorice root, and the effects and effects of the used medicinal materials are respectively as follows.

Buckwheat rhizome: is root and rhizome of Fagopyrum tataricum (L.) Gaertn. Has the effects of invigorating spleen, activating stagnancy, regulating qi-flowing, relieving pain, removing toxic substance and relieving swelling. It can be used for treating gastralgia and dyspepsia.

Walnut kernel: is dried mature seed of Juglans regia L. Besides relieving epigastric pain, walnut kernel can also help tartary buckwheat to harmonize stomach and alleviate pain because of its sweet warm nature, qi-tonifying and blood-nourishing actions.

Lily: the product is dried fleshy scale of Lilium tigrinum Thunb, Lilium browniae F.E.Brown var. viridullum Baker, or Lilium pumilum DC. Sweet and bland in flavor, neutral in nature, entering spleen and stomach meridians, heart meridian and lung meridian. Has effects in invigorating spleen, regulating stomach function, moistening lung, relieving cough, clearing away heart-fire, tranquilizing mind, and nourishing viscera. It is mainly responsible for abdominal distention and epigastric pain due to pathogenic qi, and can relieve constipation, strengthen the middle-jiao and replenish qi.

Coptis chinensis: is dried rhizome of Coptis chinensis Franch, Coptis delloidea C.Y.Cheng et Hsiao or Coptis Teata wall. The coptis root and the tartary buckwheat head have the effect of treating the root and the root of diseases caused by liver and stomach stagnated heat and damp-heat stagnation.

Evodia fruit: dried near-ripe fruits of rutaecarpa (Juss.) benth, Evodia rutaecarpa (Juss.) benth, var. officinalis (Dode) Huang or rutaecarpa glabrata rutaecarpa (Juss.) benth, var. bodinieri (Dode) Huang of Rutacarpa, rutaecarpa is pungent, bitter, warm, with the functions of lowering adverse qi and preventing vomiting, Wang Yun: wu Zhu Yu enters Jueyin (liver) with pungent and heat-energy to move qi and relieve depression, also can induce heat to descend, is combined with Huang Lian to make Zuo jin Wan, which has synergistic action on relieving symptoms.

Cuttlebone: dried inner shell of Sepiella maindroni DeRochebrune or Sepia esculenta Hoyle belonging to family Sepiidae. Cuttlebone is salty in taste, slightly warm, astringent, hemostatic, antacid and analgesic.

Thunberg fritillary bulb: dried bulb of Fritillaria thunbergii Miq. Digging when the plants wither in early summer, removing impurities, cleaning, moistening thoroughly, slicing into thick pieces, and drying. Bitter and cold in nature. Resolving stagnation, dispersing pathogen accumulation, dispersing lung qi, clearing heat, eliminating phlegm, and relieving cough. It can be used together with Os Sepiae to make WUBEI powder for treating gastric cavity pain, acid regurgitation, and hunger.

Radix angelicae: angelica dahurica. Is a plant belonging to the family Umbelliferae. The plants are distributed in northeast and northeast China of China, grow in areas with the altitude of 200-1,500 meters, and generally grow under forests, forest borders, stream sides, shrubs and valley grasslands; warm in nature, pungent, fragrant in smell and slightly bitter. The main functions are promoting granulation, relieving pain, promoting blood circulation and expelling pus.

Ligusticum wallichii: ligusticum wallichii is the dried rhizome of Ligusticum chuanxiong Hort which is a plant of Umbelliferae, is mainly produced in Pengzhou and Dujiang province of Sichuan province, is one of the Chinese medicinal materials in Sichuan origin, is warm in nature and pungent in taste, and enters liver channel, gallbladder channel, pericardium channel and spleen and stomach channel. Chuan Xiong has the actions of moving qi and relieving depression, promoting blood circulation to stop pain, treating wind-cold headache and dizziness, and cold arthralgia with spasm of tendons and muscles.

Round cardamom: dried mature fruit of Amomum cardamomum Amomurn kravanh Pierre ex Gagnep. or Amomum cardamomum Amomum compactum Soland ex Maton of Zingiberaceae. Bai Dou ren is pungent and warm in property and enters lung, spleen and stomach meridians. Bai Dou kou has the action of regulating qi and relieving epigastric distention, and is indicated for epigastric pain, abdominal distention, belching and gastric regurgitation.

Dandelion: taraxacum mongolicum hand. -Mazz, Compositae, Taraxacum perennial herbs. The root is slightly conical, is bent, is 4-10 cm long, has a tan surface, is shrunken, and has brown or yellowish-white hairy antler at the head of the root. Has the functions of clearing away heat and toxic material and treating various inflammatory gastropathy.

Cooked rhubarb: is processed product of dried root and rhizome of Rheum palmatum L, Rheum tanguticum Maxim, ex Balf. or Rheum officinale of Polygonaceae. Da Huang is bitter and cold in nature and purging it is commonly indicated for interior excess syndrome, while Da Huang is used lightly to relieve its nature, which is aimed at guiding herbs downward into stomach and directing the six fu-organs to direct them downward without pain, so they all work together to get the effect of relieving pain.

Honey-fried licorice root: glycyrrhiza uralensis Fisch (Glycyrrhiza uralensis Fisch) belonging to family Leguminosae and genus Glycyrrhiza, has strong root and rhizome. After stir-baked with honey, the tonifying property is enhanced. The moxibustion of licorice root has sweet and neutral nature and flavor, and enters heart, lung, spleen and stomach meridians. Has effects of invigorating spleen, regulating stomach function, invigorating qi, and recovering pulse. Can be used for treating weakness of the spleen and the stomach, lassitude and hypodynamia, palpitation and intermittent pulse, and has the function of harmonizing the other drugs.

Auxiliary materials: adjuvants are required in the preparation process of various dosage forms.

1. And (3) stevia: is mixed glycoside mainly containing steviosin (C38H 60018).

2. Starch: is polysaccharide granule prepared from caryopsis of Zeamays L.of Gramineae or root tuber of Manihotutissima Pohl of Euphorbiaceae.

Compatibility principle：

The compatibility method and theoretical basis of the present invention are described in detail below.

From the patent library, hundreds of published patent documents and thousands of published national document databases about the treatment of epigastric pain diseases can be retrieved, the compatibility principle and the treatment method of the traditional Chinese medicine are mostly used for solving the technical problem of treating epigastric pain by using the traditional Chinese medicine theory or the ancestral medical prescription, the theory is almost established on the basis of spleen yang, spleen qi and stomach yin, and the traditional Chinese medicine is effective to a plurality of epigastric pain diseases. However, some epigastric pain is often treated with poor or poor curative effect in clinic, and the clinical symptoms are not seen in a few cases. Aiming at epigastric pain with poor treatment effect, the invention applies a spleen yin clinical diagnosis and treatment system created by the inventor for more than thirty years, forms a compatibility principle theoretical system based on the theory of spleen yin deficiency (New Tang Xin (Jing) New Chi scientific and technical literature publisher pub published in 1992, 8 months in 1992), inputs the spleen yin theory of the inventor of high education textbooks in the national traditional Chinese medicine industry (the traditional Chinese medicine basis-traditional Chinese medicine academy-teaching material ISBN 978-7-5132-.

The formula of the invention aims at the special pathogenesis of spleen-yin clinical symptoms, and forms related multidimensional data relationships which are unclear, difficult to distinguish cause and effect, variable mixing and multiple cause and effect cause difficult-to-say multi-factor symptom results according to spleen-yin deficiency and qi weakness, which cause the invasion of vital qi deficiency and pathogenic factors, and the combination of deficiency and excess, and the diseases along viscera and stomach or the disease of the stomach and viscera. Aiming at epigastric pain caused by various factors, the traditional Chinese medicine formula with unique curative effect for treating both the spleen and the stomach of refractory epigastric pain is created based on the clinical thinking of treating the disease, seeking the root cause and treating both the symptoms and root causes.

The invention takes lily, tartary buckwheat and walnut kernel as main materials, and is matched with other medicinal ingredients to assist and complement each other, thus forming a rational and legal prescription with complete and rigorous compatibility. In the formula, the tartary buckwheat is slightly bitter and slightly cold, strengthens the spleen, promotes stagnation, regulates qi to alleviate pain, detoxifies and reduces swelling, the walnut kernels are sweet and warm, supplements qi and nourishes blood, harmonizes the stomach, moistens the intestines, warms the lung and tonifies the kidney, after the two are combined, the cold and warm compatibility is leveled, the bitter and moist are combined, the taste is sweet and light, the physical addition is not needed, the quality change of chemical regeneration is generated, the efficacies of the lily for tonifying the spleen, the stomach, the lung, the pain relieving and the five internal organs are added, and the special idea for diagnosing and treating the epigastric pain, which is in full-bodied state with the original efficacy of the unit medicine, of tonifying the spleen, the stomach, the qi and the yin, and deficiency and excess is formed. After other medicines are added, the compatibility is complete and precise, and the traditional Chinese medicine composition has unexpected curative effects on gastric cavity pain caused by gastric and duodenal ulcers, acute and chronic gastritis with erosion, gastritis with bile reflux and the like, even partial gastric cancer and other difficult and serious symptoms, such as deficiency of spleen-yin and stomach-yin, deficiency of yin and qi, alternate deficiency and excess, heat stagnation of the liver and stomach, damp stagnation, persistent gastric cavity (or rib) pain, gastric upset, pantothenic acid and belch gas, pressing or pressing refusal, and particularly on intractable gastric cavity pain caused by various reasons.

Analysis with the composition drug: the medicine of the formula mainly has the functions of removing toxicity with slight bitterness and cold, relieving hyperacidity and promoting granulation, and takes the functions of soothing the liver with pungent-warm property, regulating qi and relieving depression as the auxiliary. In the formula of the invention, the tartary buckwheat head has the effects of clearing away heat and toxic materials and promoting blood circulation to remove blood stasis, and the walnut kernel and the tartary buckwheat head have the effect of treating and curing diseases caused by liver and stomach stagnated heat and damp-heat stagnation. However, the cuttlebone has the effects of astringing to stop bleeding, relieving hyperacidity and pain and the thunberg fritillary bulb has the effects of clearing heat, resolving masses and reducing phlegm, and the combination of the cuttlebone and the thunberg fritillary bulb has the effects of relieving hyperacidity, stopping bleeding and pain when being used as the auxiliary first three medicines, but the pharmacodynamic mechanism of the cuttlebone has qualitative change after being used as the adjuvant first three main medicines, the effect of the cuttlebone is steeply increased, and the effect is multiplied. Although publications CN200310115980, CN200710018234 and the like apply the effects of astringency and hemostasis, relieving hyperacidity and pain, clearing heat and dissipating stagnation by combining cuttlebone and thunberg fritillary bulb, the difference of the invention is that the cuttlebone and the thunberg fritillary bulb are respectively compatible with the first three main medicines and the second three auxiliary medicines, so that the invention plays a role of assistant medicines and adjuvant medicines, promotes the first three main medicines and the second three auxiliary medicines to be completely fused, and can generate unexpected treatment effect on epigastric pain caused by spleen-yin deficiency.

The evodia rutaecarpa and the dahurian angelica root are both pungent and warm herbs which are used as adjuvant drugs, have the functions of combining cold and heat, warming and clearing, ascending and descending the bitter taste with pungent flavor and dispersing stagnated heat, also enhance the functions of descending adverse qi, stopping vomiting and controlling acid, and have the effect of helping to recover the ascending and descending functions of the transportation and transformation of the spleen and the stomach. The combination of the cooked rhubarb and the prepared licorice root, radix et rhizoma Rhei Praeparata mediates the former principal and the guiding herbs to guide the middle energizer, and they are used to dredge the stomach and intestine without pain and to guide the meridians and collaterals. The formula benefits the spleen to treat the stomach, treats deficiency and excess simultaneously, attacks pathogenic factors without damaging healthy energy, strengthens healthy energy and attacks pathogenic factors, highlights the characteristics of people retention and people oriented in the traditional Chinese medical treatment, and has the beneficial effects that: has unique curative effect on various epigastric pains, in particular chronic intractable yin deficiency chronic intractable epigastric pains.

The 13 Chinese herbal medicines are skillfully prepared and reasonably compatible, the medicines are compatible with each other, and the adjuvant can improve the efficacy of the main medicine; compatibility of the components is reinforced, so that the performance and the curative effect of the medicine are improved; mutual incompatibility and compatibility of medicines can reduce or eliminate the toxic and side effects of the medicines. The medicines are mutually coordinated to play the specific effects of tonifying spleen and stomach, and soothing qi and relieving pain. Particularly, the walnut kernel is a medicine and food combined traditional Chinese medicine, contains antioxidant and alpha-linolenic acid, can protect nitric oxide and tissue mucosa, is compatible with the tartary buckwheat to generate instant fusion, is favorable for exerting the pain relieving effect of the tartary buckwheat, obtains precious experience of tired use and experience through creative labor practice, and is also one of important factors and main technical characteristics of the invention. Therefore, the formula fills a gap of a special medicine for treating part of intractable epigastric pain.

Process for preparation of：

The preparation method and the process of the granular preparation for treating epigastric pain comprise the following steps:

processing and processing of medicinal materials:

lily: removing impurities, sieving to remove ash, parching with slow fire to slight yellow, taking out, and cooling;

buckwheat rhizome: cleaning, slicing and airing;

peeling semen Juglandis, removing impurities and separated wood membrane, storing in a drying container, and drying in shade;

rhizoma Coptidis, removing impurities, moistening, slicing, air drying, and mashing;

removing impurities from fructus evodiae, cleaning, slicing, and air drying;

removing impurities from Os Sepiae, cleaning, drying, and smashing into small pieces;

thunberg fritillary bulb: cutting, cleaning, moistening, slicing into thick slices, and drying; breaking into pieces when in use;

radix angelicae: removing impurities, separating into large and small pieces, slightly soaking, moistening, slicing into thick pieces, and drying;

ligusticum wallichii: removing impurities, separating into small and large pieces, soaking, cleaning, moistening, slicing, and drying;

round cardamom: and removing impurities. Mashing;

cooked rhubarb: stewing with wine or steaming with wine until the inside and the outside are black;

dandelion: removing impurities, cleaning, cutting into segments, and drying;

honey-fried licorice root: parching with honey until yellow to dark yellow, taking out when it is not sticky, and cooling.

The above-mentioned medicinal materials are processed according to the item of the variety in pharmacopeia (appendix), and the quality standard and inspection method of raw and auxiliary materials should meet the regulations of the first edition of Chinese pharmacopeia in 2005.

The preparation method and process of the granules comprise the following steps:

(1) taking all the thunberg fritillary bulb according to the weight part of the prescription, and crushing to obtain 80-100 meshes of medicinal powder for later use;

(2) taking one half of lily tartary buckwheat, walnut kernels, coptis chinensis, fructus evodiae and cuttlebone in parts by weight of a prescription, and crushing the lily tartary buckwheat, the walnut kernels, the coptis chinensis, the fructus evodiae and the cuttlebone into powder of 80-100 meshes for later use;

(3) detecting the powder recovery rate of the crushed traditional Chinese medicine components in the steps (1) and (2), wherein the average powder recovery rate is 80-95%;

(4) mixing the rest half of the lily tartary buckwheat, the walnut kernels, the coptis chinensis, the evodia rutaecarpa and the cuttlebones with the rest of the medicines which are not crushed and are in the whole prescription in parts by weight, adding clear water, standing and soaking for 15-30 minutes;

(5) filtering the soaked medicine in the step (4) to prepare decoction;

(6) adding clear water 2-4 times of the total amount of the medicines in the step (5) into the first decoction, decocting for 20-30 minutes after boiling, and extracting liquid medicine for later use; adding clear water which is 3-5 times of the total amount of the medicines in the step (5) into the second decoction, decocting for 30-40 minutes after boiling, and extracting liquid medicine for later use; adding clear water which is 4-6 times of the total amount of the medicines in the step (5) into the third decoction, decocting for 40-50 minutes after boiling, and extracting liquid medicine for later use;

(7) uniformly mixing the first, second and third extracted liquid medicines in the step (6), and standing for 3-6 hours;

(8) filtering the liquid medicine obtained in the step (7), pumping into a concentration tank, and concentrating the filtrate into clear paste with the relative density of 1.3-1.5;

(9) adding stevia into the medicinal powder and the clear paste obtained in the step (1), the step (2) and the step (8), wherein the stevia accounts for 0.5-1.5% of the total amount of the medicinal powder and the clear paste, and starch accounts for 5-15% of the total amount of the medicinal powder and the clear paste, and then uniformly mixing;

(10) adding the uniformly mixed medicine materials in the step (9) into a granulator for forming, and drying the formed granules at the drying temperature of 75-90 ℃;

(11) and (4) packaging the dried particles into small bags for each taking in a packaging machine, wherein each bag can be packaged into 5-10 g.

The preparation process of the granule for treating epigastric pain needs to meet the standard and quality requirement of the quality management system of the drug production quality management standard (goodmafacture pharmaceutical products).

The dosage form of the traditional Chinese medicine preparation for treating epigastric pain according to any one of claims 1 to 5 can be prepared into decoction, pills, capsules, tablets, powder, oral liquid or other dosage forms according to the "quality control regulations for drug production" of the quality control system.

Quality standard：

The quality standard is the basis for controlling the product quality. The traditional Chinese medicine preparation for treating epigastric pain is required to be detected from various items such as preparation, identification, inspection and the like according to the requirements of the appendix of the first edition of Chinese pharmacopoeia 2005. In the identification item, adopting microscopic identification method and thin-layer chromatography to respectively identify Bulbus Lilii, radix Et rhizoma Fagopyri Tatarici, semen Juglandis, rhizoma Coptidis, fructus evodiae, Os Sepiae, Bulbus Fritillariae Thunbergii, radix Angelicae Dahuricae, rhizoma Chuanxiong, fructus Amomi rotundus, radix Et rhizoma Rhei preparata, herba Taraxaci, and radix Glycyrrhizae Preparata, and comparing with control and negative sample; under the examination item, three batches of 9 samples are respectively taken for examination on granularity, moisture, solubility, loading difference and microbial limit, and the examination results are all in the limit range. Methodological validation was performed under the microbiological limits examination item.

Patent drug identification：

The content of berberine hydrochloride in the granule for treating epigastric pain is determined by adopting high performance liquid chromatography.

(1) Instruments and reagents: american Agilent1100 liquid chromatograph; the invention relates to a granule for treating epigastric pain; berberine hydrochloride reference (identification institute of Chinese medicinal biological products, 110713-one 200208).

(2) Chromatographic conditions are as follows: a chromatographic column: diamonsil C18 (250X 4.6mm)4 μm; mobile phase: acetonitrile-0.033 mol/l potassium dihydrogen phosphate solution (29:71, pH value adjusted to 2.0 by phosphoric acid); flow rate: 1mL min-1; detection wavelength: and 370 nm.

(3) Preparation of control solutions: weighing berberine hydrochloride reference substance dried at 100 deg.C for 5 hr, and adding mobile phase to obtain solution containing 0.1mg per 1 ml.

(4) Linear range test: precisely weighing 15.0mg of berberine hydrochloride reference substance, placing the berberine hydrochloride reference substance in a 15ml measuring flask, adding 1% of hydrochloric acid methanol to dissolve and dilute the berberine hydrochloride reference substance to a scale, precisely weighing 0.05ml, 0.1ml, 0.2ml, 0.4ml and 0.8ml, respectively placing the berberine hydrochloride reference substance in a 10ml measuring flask, adding 1% of hydrochloric acid methanol to the scale, shaking up and filtering, taking 10 mu l of subsequent filtrate to inject into a liquid chromatograph, measuring, taking the peak area product as a vertical coordinate (Y), taking the concentration of the berberine hydrochloride solution as a horizontal coordinate (X), and obtaining a regression equation as follows: Y-5X 10-5X-0.5225, r-0.9999, the conclusion indicates: the concentration of the berberine hydrochloride solution is injected in the range of 5.0-80.0 mu g/ml, and the peak area of the sample and the corresponding solution concentration form a good linear relation.

(5) Taking 10g of the product, grinding, adding 50ml of methanol, placing on a water bath, heating and refluxing for 1 hour, cooling, filtering, and taking the filtrate as a test solution. Adding methanol 20ml into control medicinal material 0.4g, and making into control medicinal material solution by the same method. Performing thin-layer chromatography (appendix VI B of the first part of the Chinese pharmacopoeia 2005), sucking 5 μ l of test solution, dropping 2 μ l of control solution on the same silica gel G thin-layer plate, developing with benzene-ethyl acetate-methanol-isopropanol-concentrated ammonia solution (12: 6: 3: 3: 1) as developing agent in a chromatographic cylinder saturated with ammonia vapor, taking out, air drying, and inspecting under ultraviolet lamp (365 nm). The same yellow fluorescent spot appears on the chromatogram of the test solution at the position corresponding to the chromatogram of the control solution. The patent medicine should conform to the regulations of the corresponding dosage form (appendix of the first edition of Chinese pharmacopoeia 2005).

(6) Taking the product, and observing under a microscope: 1-6 cells of non-glandular hair, which are straight or curved, and the wall end joint is expanded. The calcium oxalate cluster crystal diameter is 20-86 um, and the edge angle is sharp. The calcium oxalate needle crystals are fine, have the length of 10-32 mu m and are irregularly filled in the parenchyma cells. The diameter of the epidermal cells of the seed coat is 18-58 mu m, and the surface appearance is strip-shaped.

Stability test：

According to the guideline of the stability test of the medicine in the appendix of the second part of the edition 2005 of Chinese pharmacopoeia, the stability inspection items are determined as appearance shape, thin-layer chromatography identification, water content inspection and microorganism limit inspection in the acceleration and long-term test by combining the characteristics of the traditional Chinese medicine preparation for treating epigastric pain, and the stability of the preparation variety is detected according to the inspection item results.

1. Influence factor test: packaging with medicinal polypropylene composite film, standing at 60 deg.C, humidity (90% +/-5%, 25 deg.C) and strong light (5000I ×) for 10 days, and sampling for 5 days and 10 days. Influence factor test results: the product is placed for 10 days at 60 deg.C and humidity (95% +/-5%, 25 deg.C), and has the advantages of shape, chromatographic identification, water content, and microorganism limitation meeting the requirements, and stable product quality.

2. And (3) accelerated test: the medical polypropylene composite membrane is adopted for packaging, the medical polypropylene composite membrane is placed for 6 months under the conditions of temperature (40 ℃ plus or minus 2 ℃) and humidity (75% + orminus 5%), and sampling and inspecting are respectively carried out for 0 month, 1 month, 2 months, 3 months and 6 months. As a result: after an accelerated test for 6 months, the shape, the chromatographic identification, the moisture and the microbial limit of the sample all accord with the regulations, and the product quality is stable.

3. Long-term sample retention test: packaging with medicinal polypropylene composite film, and standing at 25 + -2 deg.C and humidity (60% + -10%). Samples were taken at 0, 3, 6, and 12 months for examination. As a result: the results of long-term test for 12 months show that the shape, the chromatographic identification, the water content and the microbial limit all accord with the regulations, and the product quality is stable.

The stability test result is as follows; after the accelerated test investigation for 6 months, all indexes are basically unchanged. The long-term test for 12 months shows that all indexes have no obvious change. The validity period was initially set to 12 months based on the results of the accelerated test and the long-term stability test.

Acute toxicity test：

The granular preparation for treating epigastric pain is administrated by gastric lavage to mice, observed for 7 days, LD50 of the mice is more than 25.0g/kg and is 90 times of clinical recommended dose (0.25 g/kg of adult clinical recommended dose), the mice are gavaged at 45.0g/kg and the volume is 30ml/kg, the tested mice freely move after the administration, the activity is reduced after 12 hours, no 1 mouse dies after 12 hours, and all experimental mice have hair closely attached to the body and have luster, diet, excrement and other conditions. The weight of the tested animals is increased after 7 days. According to clinical observation results and acute toxicity experiment results, the quality of the medicine is proved to be safe.

Method of treatment: the usage and dosage.

(1) Calculating the granules according to the standard of the drug content detected by the small forming package; the dosage of the patent medicine is 1-5 g for each time according to the disease condition three times a day.

(2) The people who are happy, spicy and greasy are forbidden to smoke and drink; use with cautions for pregnant women.

Examples of the invention：

The different weight parts of the formula are adopted in the embodiment, so that the formula is suitable for patients with asymptomatic epigastric pain.

Example 1: a granule for treating epigastric pain is prepared from the following traditional Chinese medicine components in parts by weight: 39 parts of lily, 38 parts of tartary buckwheat, 6 parts of walnut kernel, 7 parts of coptis chinensis, 3 parts of evodia rutaecarpa, 12 parts of cuttlebone, 13 parts of thunberg fritillary bulb, 13 parts of angelica dahurica, 13 parts of ligusticum wallichii, 9 parts of cardamom, 3 parts of cooked rhubarb, 13 parts of dandelion and 3 parts of honey-fried licorice root.

Example 1 the preparation method and process steps of the granule for treating epigastric pain are the same as the above mentioned "preparation process".

Example 2: a granule for treating epigastric pain is prepared from the following traditional Chinese medicine components in parts by weight: 22 parts of lily, 19 parts of tartary buckwheat, 4 parts of walnut kernel, 5 parts of coptis chinensis, 1 part of evodia rutaecarpa, 5 parts of cuttlebone, 7 parts of thunberg fritillary bulb, 6 parts of angelica dahurica, 8 parts of ligusticum wallichii, 5 parts of cardamom, 1 part of cooked rhubarb, 6 parts of dandelion and 1 part of honey-fried licorice root.

Example 2 the preparation method and process steps of the granule for treating epigastric pain are the same as the above mentioned "preparation process".

Example 3: a granule for treating epigastric pain is prepared from the following traditional Chinese medicine components in parts by weight: 28 parts of lily, 30 parts of tartary buckwheat, 4 parts of walnut kernel, 6 parts of coptis chinensis, 3 parts of fructus evodiae, 8 parts of cuttlebone, 11 parts of thunberg fritillary bulb, 9 parts of angelica dahurica, 12 parts of ligusticum wallichii, 6 parts of cardamom, 3 parts of cooked rhubarb, 9 parts of dandelion and 2 parts of honey-fried licorice root.

Example 3 the preparation method and process steps of the granule for treating epigastric pain are the same as the above mentioned "preparation process".

Criteria for efficacy assessment：

Four efficacy outcomes were used for the evaluation criteria.

And (3) curing: the epigastric pain symptom disappears, the appetite is enhanced, the intestines and the stomach are unobstructed, the epigastric pain symptom is not caused, and the epigastric pain does not relapse after healing.

The method has the following advantages: obviously improving the epigastric pain symptom, enhancing appetite, smoothing intestines and stomach, and obviously relieving the epigastric pain symptom.

The effect is shown: the symptoms of epigastric pain are improved, the appetite is realized, the intestines and the stomach are smooth, and the symptoms of epigastric pain are relieved.

And (4) invalidation: the epigastric pain symptoms are not improved, and the epigastric pain symptoms are not obviously changed before administration.

Observation of therapeutic effects：

The observation of the curative effect adopts the commonly used Sanjiuweitai granules for comparison.

Compared with the prior art, the granule for treating epigastric pain has the following beneficial effects: the efficacy of the formulation of the present invention (using the formulation of example 3 above) in treating epigastric pain was compared with that of the granule of saururus chinensis var. The method comprises the following steps: randomly dividing 364 collected epigastric pain patients into a treatment group and a control group, wherein 200 cases of the treatment group are orally taken by the granules (three times a day for an adult, 5g for each time, and 7-10 days as a treatment course); 164 cases of the control group, oral Sanjiuweitai granules (following the product instruction for oral administration), and observing the treatment result of the epigastric pain patients;

after 1-2 courses of treatment, the results were as follows:

the total effective rates of the treatment group and the control group are respectively 92.4 percent and 73.2 percent, and the significant difference (P <0.01) is obtained through statistical treatment. And (4) conclusion: the invention has obvious curative effect on epigastric pain patients. In clinical use for more than 30 years, no obvious serious adverse reaction caused by taking the epigastric pain granules is found at present, and the epigastric pain traditional Chinese medicine preparation is proved to be safe and effective when being taken in conventional dose treatment and has low toxic and side effects. In long-term administration of large dose, no uncomfortable symptoms, nausea or diarrhea, etc.

1. The invention is a pure Chinese medicinal preparation, and has the following beneficial effects: the compatibility of various medicinal materials brings out the best in each other, has the effects of dispelling cold and drying dampness, soothing the liver and regulating qi, promoting qi circulation and regulating middle warmer, warming middle warmer and strengthening spleen, and is suitable for treating epigastric pain caused by symptoms such as acute and chronic gastroenteritis, gastric ulcer, gastrorrhagia, stomachache, nausea and vomiting by adjusting the parameters of the formula according to various epigastric pain symptoms.

2. The invention has good curative effect, small toxic and side effect, safety and reliability, can be used for a long time, and has scientific and reasonable preparation method.

Clinical cases:

Clinical cases were randomly drawn patients of recent years.

Case 1: liu XX, female, 50 years old, Yuanchan city, Yuchuan county, Sichuan province. The stomach illness has been in the past for many years, and the onset of the disease is aggravated for one month. Epigastric pain, nausea, vomiting, lassitude, abdominal distension with low fever. The effect is poor when the medicine is used for treating the chronic rhinitis. The physician was examined as erosive gastritis with duodenal ulcer by the introduction to the friend. After the traditional Chinese medicine preparation is taken for one month, the symptoms basically disappear. The treatment is continued for one month, the symptoms are completely disappeared, and the superficial gastritis is rechecked. Thereafter, the body is healthy. Visit at 11 months and 3 days in 2018: no relapse occurs in 10 years, and the probability is shown: "ten years of illness, one decade of treatment".

Case 2: liao XX, male, 53 years old, Sichuan province urban. Patients have stomach ache and gastrectasia, nausea, hiccup, choking gas, inappetence, lassitude and daily emaciation. The curative effect is not good enough in 30 years, and the pain is very painful when the pain occurs. The patient is diagnosed by introduction, gastric ulcer and epigastric pain are confirmed, after two continuous months, the symptoms of the stomachache and the gastrectasia are obviously relieved, the pain is continuously consolidated for 30 years after one month, the patient is Huolukang, the pain is eliminated, the stomach function is recovered to be normal, the ulcer is completely cured after rechecking, and the patient can drink wine as usual after that, which surprises the rest of people. Visit on day 4 of 11 months in 2018: so far, there was no recurrence for 5 years.

Case 3: papermulberry X, male, Alibaba president. Initial diagnosis in 2018, 4 months and 1 day. Patients suffering from epigastric pain take various medicines for 2 years, the curative effect is poor, and the patients are diagnosed with the epigastric pain in a special way with the same name. After the traditional Chinese medicine preparation is taken for half a month (1 course of treatment), the stomachache is obviously improved, and the stomachache disappears after the traditional Chinese medicine preparation is continuously taken for half a month, and the stomachache does not relapse after the follow-up visit after half a year.

Case 4: WanX, male, 34 years old, farmer. Epigastralgia with anorexia, bitter sour water in mouth, lassitude, asthenia, cold body, aversion to wind, emaciation, frequent dizziness and blurred vision. The patients go to a plurality of hospitals for treatment and are treated by a plurality of methods, and the improvement is not seen. The diagnosis is made by the introduction of friend, epigastric pain and consumptive disease are diagnosed, after taking the traditional Chinese medicine preparation for half a month, the symptoms are obviously relieved, after taking the traditional Chinese medicine preparation for 1 month, the symptoms are completely disappeared, and after 3 months, follow-up visit is carried out without relapse.

Therapeutic results：

Statistics of treatment outcomes partial statistics of patients treated in the last two years were taken.

Nearly 10 ten thousand patients have been treated in three decades, and the total effective rate reaches 95.7 percent after two treatment courses of treatment according to 6253 patients received in the statistics part of 2017 and 2018, wherein 4207 patients are cured, 1216 patients are effective, 562 patients are effective and 268 patients are ineffective.

The above description is only an embodiment of the present invention, but the scope of the present invention is not limited thereto, and any changes or substitutions that are not thought of through the inventive work should be included in the scope of the present invention.

Claims

1. The traditional Chinese medicine composition for treating yin deficiency epigastric pain is characterized by comprising the following traditional Chinese medicine components in parts by weight: 20-41 parts of lily, 20-41 parts of tartary buckwheat, 3-8 parts of walnut kernel, 4-9 parts of coptis chinensis, 1-5 parts of evodia rutaecarpa, 5-14 parts of cuttlebone, 6-15 parts of thunberg fritillary bulb, 6-15 parts of angelica dahurica, 6-15 parts of ligusticum wallichii, 4-11 parts of cardamom, 1-4 parts of cooked rhubarb, 6-15 parts of dandelion and 1-4 parts of honey-fried licorice root;

the yin-deficiency epigastric pain belongs to the epigastric pain caused by yin deficiency of spleen and stomach, yin deficiency, weak qi, alternate deficiency and excess, stagnation heat of liver and stomach and dampness stasis;

the main medicines compatible in the traditional Chinese medicine composition comprise lily, tartary buckwheat and walnut kernel.

2. The traditional Chinese medicine composition for treating yin deficiency epigastric pain according to claim 1, is further characterized by comprising the following traditional Chinese medicine components in parts by weight: 25-35 parts of lily, 25-35 parts of tartary buckwheat, 4-6 parts of walnut kernel, 5-7 parts of coptis chinensis, 1-3 parts of evodia rutaecarpa, 7-11 parts of cuttlebone, 8-12 parts of thunberg fritillary bulb, 8-12 parts of angelica dahurica, 7-12 parts of ligusticum wallichii, 5-9 parts of cardamom, 2-3 parts of cooked rhubarb, 8-12 parts of dandelion and 1-3 parts of honey-fried licorice root.

3. The traditional Chinese medicine composition for treating yin deficiency epigastric pain according to claim 1, is further characterized by comprising the following traditional Chinese medicine components in parts by weight: 38 parts of lily, 39 parts of tartary buckwheat, 6 parts of walnut kernel, 7 parts of coptis chinensis, 3 parts of evodia rutaecarpa, 12 parts of cuttlebone, 13 parts of thunberg fritillary bulb, 13 parts of angelica dahurica, 13 parts of ligusticum wallichii, 9 parts of cardamom, 3 parts of cooked rhubarb, 13 parts of dandelion and 3 parts of honey-fried licorice root.

4. The traditional Chinese medicine composition for treating yin deficiency epigastric pain according to claim 1, is further characterized by comprising the following traditional Chinese medicine components in parts by weight: 22 parts of lily, 24 parts of tartary buckwheat, 4 parts of walnut kernel, 5 parts of coptis chinensis, 2 parts of evodia rutaecarpa, 6 parts of cuttlebone, 7 parts of thunberg fritillary bulb, 7 parts of angelica dahurica, 8 parts of ligusticum wallichii, 6 parts of cardamom, 2 parts of cooked rhubarb, 7 parts of dandelion and 2 parts of honey-fried licorice root.

5. The traditional Chinese medicine composition for treating yin deficiency epigastric pain according to claim 1, is further characterized by comprising the following traditional Chinese medicine components in parts by weight: 30 parts of lily, 32 parts of tartary buckwheat, 5 parts of walnut kernel, 6 parts of coptis chinensis, 2 parts of evodia rutaecarpa, 9 parts of cuttlebone, 10 parts of thunberg fritillary bulb, 10 parts of angelica dahurica, 10 parts of ligusticum wallichii, 7 parts of cardamom, 2 parts of cooked rhubarb, 10 parts of dandelion and 2 parts of honey-fried licorice root.