CN111450163B

CN111450163B - Coptis pharmaceutical composition and application thereof

Info

Publication number: CN111450163B
Application number: CN201910048846.5A
Authority: CN
Inventors: 李学刚; 叶小利
Original assignee: Southwest University
Current assignee: Southwest University
Priority date: 2019-01-18
Filing date: 2019-01-18
Publication date: 2021-10-08
Anticipated expiration: 2039-01-18
Also published as: CN111450163A

Abstract

The invention belongs to the technical field of traditional Chinese medicine preparation, and particularly relates to a coptis chinensis medicine composition for treating stomach diseases and application thereof. The coptis medicinal composition adopts superfine powder of coptis and evodia and an effervescent disintegrant, when the medicinal composition is contacted with gastric juice, the medicinal composition is instantly boiled and disintegrated, a large amount of coptis alkaloid and evodia alkaloid are released in a short time, gastric microorganisms are killed, and diseases and gastric cancer caused by gastric microorganisms are cured; the adopted superfine powder of the coptis and the evodia is raw medicinal material powder, active ingredients are completely released, the curative effect on stomach diseases is excellent, and the condition that the curative effect is insufficient due to insufficient extraction of certain alkaloids when an extract is adopted is avoided; the adopted effervescent disintegrant does not contain acid, only contains sodium carbonate or sodium bicarbonate, and has better moisture resistance and higher storage stability.

Description

Coptis pharmaceutical composition and application thereof

Technical Field

The invention belongs to the technical field of traditional Chinese medicine preparation, and particularly relates to a coptis chinensis medicine composition and application thereof.

Background

Huang Lian was recorded in Shen nong Ben Cao Jing, listed as the superior. Coptis root, rhizoma Coptidis is bitter in taste and cold in nature, and has the effects of purging pathogenic fire, removing toxic substance, clearing heat, and eliminating dampness. Can be used for treating dysphoria, coma, vexation, insomnia, damp-heat, abdominal distention, emesis, abdominal pain, dysentery, conjunctival congestion, toxic swelling, aphtha, eczema, scald, hematemesis, and epistaxis. The famous classic formula ZUOJIN pill with Coptidis rhizoma as main material is from Danxi Xin Fa, has effects of purging liver fire, removing dampness, and relieving oppression and knot, is mainly used for treating liver fire invasion of stomach, tongue and groove mixed acid regurgitation, emesis hypochondriac pain, tendon hernia and lump, cholera and spasm, etc., and is a famous Chinese medicine prescription for treating stomach diseases. However, zuojin pills are prepared by a rough process (6 parts of coptis root and 1 part of evodia rutaecarpa are crushed into fine powder, sieved, mixed uniformly and made into pills with water, see the' 2015 edition of Chinese pharmacopoeia), and have poor taste and large volume; meanwhile, researches find that the effective components of the Zuojin pill are dissolved in gastric juice at a slow speed and quickly leave the stomach to enter the small intestine along with the peristalsis of the stomach, so that the curative effect of the Zuojin pill on the stomach is weakened. Based on the ZUOJIN pill, the volume is remarkably reduced by extracting and processing the developed ZUOJIN capsule; however, the active ingredients of the coptis chinensis alkaloid are rich, the solubility of hydrochloride of partial active ingredients is low, especially, the coptis chinensis is a perennial medicinal material, the lignification and the fibrosis are serious, and the cell wall is blocked, so that the active ingredients are not fully extracted in the existing extraction process; meanwhile, the residence time of the Zuojin capsule in the stomach is not enough, and the curative effect is not satisfactory (see the 'Chinese pharmacopoeia' 2015 edition, the loss of effective components is more than 15%).

In order to prolong the retention time of the Zhaojin capsule in the stomach, Zhao Xinhui et al developed the gastric floating tablet of Zhaojin capsule (Zhao Xinhui, Liu Dou, kojiu jin storehouse. hydroxypropyl methylcellulose influenced the floating performance and drug release characteristics of the gastric floating sustained release tablet of Zhaojin, Chinese patent medicine 29 (7): 988, 2007.), but still did not solve the problem of insufficient extraction of the components of Coptidis rhizoma and evodia rutaecarpa. Patent technologies and documents and the like for extracting Zuojin pills by ethanol or water and then processing the Zuojin pills into various floating tablets or microemulsion gels and the like are reported, but the problem of total alkaloid loss in the existing extraction technology is still not well solved.

Patent ZL200510087258.0 discloses a rapid dispersion solid formulation of zujin comprising: pulverizing or extracting the Chinese medicinal materials of ZUOJIN pill, micronizing to obtain main materials, mixing with adjuvants selected from disintegrating agent, adhesive, suspending agent, glidant, correctant, and color correcting agent, and making into preparation by conventional technique, wherein the particle sizes of all the main materials and adjuvants are less than 75 μm. The disintegrating agent of the technology comprises super carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, cross-linked polyvinylpyrrolidone, cross-linked sodium carboxymethyl cellulose, starch and microcrystalline cellulose; the binder comprises povidone; the suspending agent comprises xanthan gum, carbomer, HPMC, and guar gum; the glidant comprises superfine silica gel powder, talcum powder and magnesium stearate; the corrigent comprises various essences, and the corrigent is pigment with any gram of medicine. The speed of the product for releasing the effective components of the coptis chinensis is not fast enough.

Disclosure of Invention

In order to solve the problems, firstly, the coptis chinensis and the evodia rutaecarpa are further refined on the basis of the prior art, but after the superfine powder after being refined is subjected to pelleting, the release speed is detected, and the release speed is not greatly improved; in the test, the ultra-fine 'ultra-micro powder' is found to be easy to form small particles, so that the release degree is not ideal.

Subsequently, a disintegrating agent is added, and theoretically, the disintegrating agent is beneficial to improving the 'disintegration' of the particles, and the dissolution of the active ingredients and the floating of the medicine are accelerated, but actually, the release degree is not obviously improved; through a large number of researches, part of auxiliary materials (such as sodium carboxymethyl starch in a disintegrating agent, xanthan gum serving as a suspending agent and the like) in the medicine and the coptis alkaloid easily form insoluble salt, so that the solubility of the coptis alkaloid is reduced and the coptis alkaloid is not easily released. Further research and screening of a large number of experiments are carried out on the coptis alkaloid to obtain a specific disintegrating agent which does not react with the coptis alkaloid; after the special disintegrating agent is added, the speed of releasing the effective components is obviously accelerated.

In order to further improve the dissolution speed, an effervescent agent is added into the formula, the effervescent agent can release the effective ingredients of the medicine instantly, and the experimental result shows that the addition of the effervescent agent (such as a compound of sodium bicarbonate and citric acid) can accelerate the disintegration of the product, but reduces the release of part of coptis alkaloid; intensive research finds that the citric acid in the effervescent agent and part of the coptis alkaloid form a double salt, the solubility of the coptis alkaloid is reduced, and the amount of the released effective components is reduced; on the other hand, if the citric acid is not added, the carbon dioxide can not be released, and the effervescent effect can not be formed; based on the fact that the stomach contains a large amount of hydrochloric acid, the inventor only selects alkali metal carbonate or bicarbonate as an effervescent agent and simultaneously combines the effervescent agent with a specific disintegrating agent and superfine micropowder, so that the product can rapidly release gas and disintegrate at the moment of contacting with the gastric juice, a large amount of effective ingredients are released at the moment, the concentration of the effective ingredients in the gastric juice is rapidly increased, and gastric microorganisms are killed.

The technical scheme provided by the invention is as follows: a coptis chinensis pharmaceutical composition comprises the following components by weight: 400-800 parts of coptis chinensis superfine powder, 50-150 parts of fructus evodiae superfine powder, 1-100 parts of effervescent disintegrant and/or 1-100 parts of disintegrant, wherein the coptis chinensis superfine powder and the fructus evodiae superfine powder are both obtained by sieving with a 500-mesh sieve, the effervescent disintegrant is a substance which can generate carbon dioxide when contacting with acid in pharmaceutics, and the disintegrant is selected from starch or/and microcrystalline cellulose.

Preferably, the effervescent disintegrant is sodium carbonate and/or sodium bicarbonate.

Preferably, the coptis pharmaceutical composition comprises by weight: 500 portions of coptis superfine powder, 50 to 150 portions of evodia superfine powder, 10 to 100 portions of effervescent disintegrant and 10 to 100 portions of disintegrant.

Preferably, the coptis pharmaceutical composition comprises by weight: 500 portions of coptis superfine powder, 50 to 150 portions of evodia superfine powder, 50 to 100 portions of effervescent disintegrant and 50 to 100 portions of disintegrant.

More preferably, the mass ratio of the coptis chinensis superfine powder to the fructus evodiae superfine powder is 6: 1.

Preferably, the coptis chinensis superfine powder and the fructus evodiae superfine powder are obtained by sieving with a 5000-mesh sieve.

The composition can be immediately disintegrated and boiled after entering stomach, and can rapidly release high concentration Coptidis rhizoma alkaloid and other effective components, kill stomach helicobacter pylori and other microorganisms, and cure stomach diseases.

The application of the rhizoma coptidis medicinal composition in preparing a medicament for treating gastropathy. Preferably, the stomach disease is a stomach disease caused by helicobacter pylori, and more preferably, the stomach disease is gastric cancer or gastric ulcer.

Preferably, the medicament is a pill or a tablet prepared from the coptis chinensis medicinal composition, or a pill or a tablet prepared from the coptis chinensis medicinal composition and a medicinal auxiliary material which is prepared into a certain dosage form and is added.

Preferably, the medicament is a pill and the gastric disorder is gastric cancer. More preferably, the pills are prepared by uniformly mixing superfine coptis powder and superfine evodia powder in the medicinal composition, then adding water solution of a disintegrating agent and an effervescent disintegrating agent for spraying, and then pelleting and drying.

The invention has the beneficial effects that:

1. the coptis medicinal composition disclosed by the invention is prepared by matching superfine powder of coptis and evodia and an effervescent disintegrant, when the medicinal composition is contacted with gastric juice, the medicinal composition is instantly boiled and disintegrated, a large amount of coptis alkaloid is released in a short time, gastric microorganisms are killed, and diseases and gastric cancer caused by gastric microorganisms are cured;

2. in the coptis medicinal composition, the superfine powder of the coptis and the evodia is adopted, so that the active ingredients are completely released, the curative effect on stomach diseases is excellent, and the condition that the curative effect is insufficient due to insufficient extraction of some alkaloids when the extract is adopted is avoided;

3. the effervescent disintegrant in the coptis medicinal composition does not contain acid, only contains sodium carbonate and sodium bicarbonate, and has higher storage stability.

Detailed Description

In the following, the technical solutions in the embodiments of the present invention will be clearly and completely described, and it is obvious that the described embodiments are only some embodiments of the present invention, and not all embodiments. All other embodiments, which can be obtained by a person skilled in the art without any inventive step based on the embodiments of the present invention, belong to the scope of the present invention.

In addition, unless otherwise specifically indicated, various starting materials, reagents, instruments and equipment used in the present invention may be commercially available or prepared by existing methods.

EXAMPLE 1 effervescent Zuojin pill preparation

400g of coptis chinensis and 150g of fructus evodiae, and crushing the coptis chinensis and the fructus evodiae into 500 meshes; dissolving 1g of sodium bicarbonate in a proper amount of water, granulating according to the traditional water-pelleting process, and drying to obtain the Zuojin pill.

EXAMPLE 2 effervescent Zuojin pill preparation

800g of coptis chinensis and 50g of fructus evodiae, and crushing the coptis chinensis and the fructus evodiae into 5000 meshes; 1g of microcrystalline cellulose, and uniformly mixing the microcrystalline cellulose and the medicine powder; granulating according to conventional water-pill process, and oven drying to obtain ZUOJIN pill.

EXAMPLE 3 effervescent Zuojin pill preparation

600g of coptis chinensis and 100g of fructus evodiae, and crushing into 50000 meshes; 100g of sodium carbonate and 100g of hydroxypropyl cellulose; mixing microcrystalline cellulose and the medicinal powder uniformly; dissolving sodium carbonate in appropriate amount of water, granulating according to conventional water-pelleting process, and oven drying to obtain ZUOJIN pill.

EXAMPLE 4 effervescent Zuojin pill preparation

600g of coptis chinensis and 100g of fructus evodiae, and crushing the coptis chinensis and the fructus evodiae into 500000 meshes; 50g of sodium bicarbonate and 50g of starch; mixing starch and medicinal powder; dissolving sodium bicarbonate in appropriate amount of water, granulating according to conventional water-pelleting process, and oven drying to obtain ZUOJIN pill.

EXAMPLE 5 effervescent Zuojin pill preparation

600g of coptis chinensis and 100g of fructus evodiae, and crushing the coptis chinensis and the fructus evodiae into 10000 meshes; 10g of sodium bicarbonate and 10g of microcrystalline cellulose; mixing microcrystalline cellulose and the medicinal powder uniformly; dissolving sodium bicarbonate in appropriate amount of water, granulating according to conventional water-pelleting process, and oven drying to obtain ZUOJIN pill.

EXAMPLE 6 comparative experiment on release rate of active ingredient of product obtained by the present invention

(1) Test drug 1: effervescent zuojin pills prepared according to example 1.

(2) Test drug 2: effervescent zuojin pills were prepared as in example 5.

(3) Control drug 1: the ZUOJIN pill is prepared according to the preparation process of ZUOJIN pill in 2015 edition of Chinese pharmacopoeia.

(4) Control drug 2: 600g of coptis chinensis and 100g of fructus evodiae, and the medicaments are crushed to 500 meshes, and are prepared into Zuojin pills according to the preparation process of Zuojin pills under the item of the 2015 edition of Chinese pharmacopoeia.

(5) Control drug 3: 600g of coptis chinensis and 100g of fructus evodiae, and the medicaments are crushed to 5000 meshes, and are prepared into zuojin pills according to the preparation process of zuojin pills under the item of the 2015 edition of Chinese pharmacopoeia.

(6) Control drug 4: 600g of coptis chinensis and 100g of fructus evodiae, and the medicaments are crushed into 50000 meshes, and are prepared into Zuojin pills according to the preparation process of Zuojin pills under the item of the 2015 edition of Chinese pharmacopoeia.

(7) Control drug 5: 600g of coptis chinensis, 100g of fructus evodiae, 10g of citric acid and 4.4g of sodium bicarbonate, and the Zuojin pill is prepared by crushing the medicines into 50000 meshes and preparing the Zuojin pill according to the preparation process of the Zuojin pill under the item of the national pharmacopoeia 2015 edition.

(8) Control drug 6: 600g of coptis chinensis, 100g of fructus evodiae and 10g of croscarmellose sodium, and the medicaments are crushed into 50000 meshes, and the Zuojin pill is prepared according to the preparation process of the Zuojin pill under the item of the 'Chinese pharmacopoeia' 2015 edition.

(9) Control drug 7: zuojin pellets prepared according to example 1 of patent ZL 200510087258.0: taking 600g of coptis chinensis and 100g of fructus evodiae, carrying out ultrafine grinding, sieving with 400 meshes, uniformly mixing 100 parts of powder per volume with auxiliary materials, tabletting, and coating with a new fefield coating material.

In vitro release assay: the first method, the basket-rotating method, was used to determine the release in the appendix of the Chinese pharmacopoeia (second part) of the 2015 edition. 1000ml of artificial gastric juice, and the temperature (37 +/-0.5) DEG C. Taking about 5 pills of the medicine (controlling the consistent amount of the coptis medicine), precisely weighing, putting into 6 dry rotating baskets, adjusting the rotating speed of the rotating baskets to be 100r/min, after the rotating baskets are stable, putting the rotating baskets into a constant-temperature dissolution cup, immediately timing when a sample contacts a dissolution medium, directly sampling 3ml (supplementing a fresh medium by 3ml after each sampling) after the specified time, and filtering by using a 0.22 mu m microporous membrane. Taking the filtrate, respectively measuring the contents of berberine, coptisine, palmatine and epiberberine by an HPLC method, and calculating the accumulated release degree. The results are shown in Table 1.

TABLE 1 Release degree of drug in Artificial gastric juice (mg/L)

As can be seen from Table 1, the tested drugs are put into the artificial gastric juice, and a certain amount of coptis alkaloid is released into the artificial gastric juice within 0.1 minute; substantially complete release into artificial gastric fluid in 5 minutes; the control drug 1 (traditional Zuojin pill) released coptis alkaloid very slowly, even by 30 minutes, half of the coptis alkaloid released was not yet tested, at which time the drug gradually left the stomach; the release rate of the contrast medicine is obviously higher than that of the traditional Zuojin pill, but the release rate is obviously lower than that of the 'effervescent Zuojin pill' (test medicine), and the released coptis alkaloid is only about 70 percent of that of the effervescent Zuojin pill in 30 minutes. Meanwhile, the patent technology (ZL200510087258.0) processed ZUOJIN pill has the defects that the coptis alkaloid is difficult to completely release, even 60 minutes, the coptis alkaloid cannot be completely released, and even the release of some alkaloids (such as berberine and coptisine) is lower than that of the traditional ZUOJIN pill. This may be associated with the patent application (ZL200510087258.0) of sodium carboxymethyl starch in the formulation, which is negatively charged, and which forms an insoluble salt in combination with positively charged coptis alkaloids (especially partially poorly water-soluble alkaloids such as berberine and coptisine) and is insoluble in gastric juice.

From the alkaloid release rates in the control drugs 1-4, the speed of releasing the active ingredients of the drugs and the amount of the released drugs are slightly increased but not significantly increased as the crushed particle size of the drugs becomes smaller (control drugs 1-4); compared with the control drug groups 4, 5 and 6, the dissolution of the coptis alkaloid is not increased but decreased after the effervescent agent or the disintegrant (croscarmellose sodium) containing citric acid is added, and particularly, the berberine and the coptisine with smaller water solubility are decreased more.

Example 7 comparison of anti-Helicobacter Pylori (HP) Effect

(1) Test drug 1: effervescent zuojin pills prepared according to example 1.

(2) And test drug 2: effervescent zuojin pills were prepared as in example 5.

(3) And control drug 1: the ZUOJIN pill is prepared according to the preparation process of ZUOJIN pill in 2015 edition of Chinese pharmacopoeia.

(4) And control drug 2: 600g of coptis chinensis and 100g of fructus evodiae, and the medicaments are crushed to 500 meshes, and are prepared into Zuojin pills according to the preparation process of Zuojin pills under the item of the 2015 edition of Chinese pharmacopoeia.

(5) And a control drug 3: 600g of coptis chinensis and 100g of fructus evodiae, and the medicaments are crushed to 5000 meshes, and are prepared into zuojin pills according to the preparation process of zuojin pills under the item of the 2015 edition of Chinese pharmacopoeia.

(6) And control drug 4: 600g of coptis chinensis and 100g of fructus evodiae, and the medicaments are crushed into 50000 meshes, and are prepared into Zuojin pills according to the preparation process of Zuojin pills under the item of the 2015 edition of Chinese pharmacopoeia.

(7) And a contrast drug 5: 600g of coptis chinensis, 100g of fructus evodiae, 10g of citric acid and 4.4g of sodium bicarbonate, and the Zuojin pill is prepared by crushing the medicines into 50000 meshes and preparing the Zuojin pill according to the preparation process of the Zuojin pill under the item of the national pharmacopoeia 2015 edition.

(8) And a control drug 6: 600g of coptis chinensis, 100g of fructus evodiae and 10g of croscarmellose sodium, and the medicaments are crushed into 50000 meshes, and the Zuojin pill is prepared according to the preparation process of the Zuojin pill under the item of the 'Chinese pharmacopoeia' 2015 edition.

(9) And control drug 7: zuojin pellets prepared according to example 1 of patent ZL 200510087258.0: taking 600g of coptis chinensis and 100g of fructus evodiae, carrying out ultrafine grinding, sieving with 400 meshes, uniformly mixing 100 parts of powder per volume with auxiliary materials, tabletting, and coating with a new fefield coating material.

Animal experiments (Yangchen et al. experimental study of gastric Youkang gastric floating tablets against helicobacter pylori and gastric ulcer. pharmaceutical journal of Chinese Hospital, 2018, 38(5), 482)): (1) preparation of HP-infected mouse model: feeding Kunming mice adaptively for 1d, fasting for 12h, sterilizing each mouse with 0.2mL ethanol, and recovering normal drinking water after 2 h. The pretreated mice were then fasted for 12h and then each mouse was gavaged with 0.5mL of HP suspension (1X 109 CFU. mL-1) for 4 times at 12-hour intervals. Recovering drinking water after 2h after last gastric lavage. After 5 weeks 5 mice were sacrificed at random and antral tissues were taken for urease, bacteriological smear examination and histological examination to determine whether HP was successfully infected. (2) animal grouping and administration: the molded animals were randomly divided into 11 groups of 15 animals each, namely: the dosage of a normal control group, a model control group, a test drug 1 group (1.8 g.Kg-1. d-1), a test drug 2 group (1.8 g.Kg-1. d-1) and a control drug 1-5 group (1.8 g.Kg-1. d-1) is converted by a conversion coefficient method, and the dosage is 12g (the dosage administered by Chinese pharmacopoeia) taken by an adult every day. Each administration group has 0.4mmL-1 (prepared from purified water to obtain test solution), and normal control group and model group are administered with equal amount of physiological saline 0.4mL each time, 1 time per day, and continuously for 5 weeks. (3) Detection indexes are as follows: after the last administration, fasting was performed for 24h, the animals were sacrificed and antral tissues were taken for urease, bacteriological smear examination and histological examination to determine the presence of HP. Under the aseptic condition, taking out the stomach of the rat, cutting the rat along the greater curvature of the stomach, washing residues with sterile physiological saline, cutting the antrum part along the longitudinal axis, cutting the antrum into three parts, and using one part for smear microscopy: sticking the mucosa surface of the antrum of the stomach of the mouse on a glass slide for smear, and performing microscopic examination after gram staining; one part was used for histological examination: fixing the gastric tissue block by formaldehyde, and performing HE staining and Giemsa staining on the tissue section respectively; the other part was used for urease test. In 3 detection methods, the mouse gastric mucosa is determined to have HP infection as long as 2 detection methods are positive, and the 3 detection methods are negative, and the mouse gastric mucosa is diagnosed to have no HP infection. The results are shown in Table 2.

TABLE 2 clearance of helicobacter pylori by the drug

Medicine	Clearance (%)
		Experimental drug 1	86
Experimental drug 2	93
		Control drug 1	33
Control drug 2	40
		Control drug 3	47
Control drug 4	47
		Control drug 5	40
Control drug 6	40
		Control drug 7	53

As can be seen from Table 2, the test drugs exhibited high clearance of helicobacter pylori, and particularly the test drug 2 was very desirable; the traditional Zuojin pill has low clearance rate, and the effect is increased along with the reduction of the crushing granularity; after the effervescent agent or the disintegrant (croscarmellose sodium) containing citric acid is added, the clearance rate of helicobacter pylori is reduced; the clearance rate of the product of the patent technology to the helicobacter pylori is improved compared with the traditional Zuojin pill, but the product is still not ideal and is obviously lower than the test drug group.

Example 8 comparison of anti-gastric cancer Effect

(1) Test drug 1: effervescent zuojin pills prepared according to example 1.

(2) And test drug 2: effervescent zuojin pills were prepared as in example 5.

(7) And a contrast drug 5: 600g of coptis chinensis, 100g of fructus evodiae, 10g of citric acid and 4.4g of sodium bicarbonate, and is prepared into Zuojin pills according to the preparation process of Zuojin pills under the item of the 'Chinese pharmacopoeia' 2015 edition.

90 BALB/c-nu nude mice with 4 weeks old are fed in a single cage, a barrier isolation system is balanced for 3-5 days, and sterile feed and water are sufficient. Nude mice were randomly divided into 9 groups of 10 mice each, each group of nude mice was inoculated with gastric cancer tumor cells (BGC-823) (0.1 mL/mouse) except for the negative control group, the mice were sacrificed after 30 days by administering experimental drug at a dose of 1.8g/Kg, the mice were sacrificed, tumor masses were removed, weighed, analyzed and compared for the average weight of tumor tissues of each group, and the results are shown in Table 3.

TABLE 3 antitumor Effect test

Test group	Mean tumor weight/g	Tumor incidence/%)
			Negative control group	0.00±0.00	0
Positive control group	1.51±0.54	100
			Test group 1	0.71±0.35*	80
Test group 2	0.64±0.21**#	60
			Control group 1	1.21±0.47	100
Control group 2	1.10±0.31	100
			Control group 3	1.02±0.33	100
Control group 4	0.99±0.32	90
			Control group 5	1.11±0.35	100
Control group 6	1.13±0.23	100
			Control group 7	0.91±0.37*	90

The test results showed that both the drug group and the control drug group had anti-gastric cancer effects compared to the positive control group (#group): the test drug group has obvious effect on resisting gastric cancer, the anti-cancer effect of the test drug group reaches an obvious level, and particularly the test drug group 2 reaches an extremely obvious level; the test drug group also had the effect of preventing gastric cancer. The traditional Zuojin pill also has certain effect of inhibiting the growth of tumor, but is not obvious and does not reach the obvious level; the anti-cancer effect is increased along with the reduction of the granularity of the superfine powder; after citric acid and a disintegrating agent (croscarmellose sodium) are added, the inhibition rate of gastric cancer is reduced; the patent medicine group also has the effect of inhibiting and preventing gastric cancer, but the effect is obviously poorer than that of the experimental group. Compared with the patent technology drug group, the effect of inhibiting and preventing the seed tumor is obviously improved (#), and the obvious level is achieved.

Claims

1. The coptis pharmaceutical composition is characterized by comprising the following components in parts by weight: 400 portions of coptis superfine powder, 50 to 150 portions of evodia superfine powder and 1 to 100 portions of effervescent disintegrant; or 400-800 parts of coptis superfine powder, 50-150 parts of evodia superfine powder, 1-100 parts of effervescent disintegrant and 1-100 parts of disintegrant; the coptis chinensis superfine powder and the evodia rutaecarpa superfine powder are obtained by sieving with a 500-mesh sieve, the effervescent disintegrant is sodium bicarbonate, and the disintegrant is microcrystalline cellulose.

2. The coptis pharmaceutical composition according to claim 1, which consists of the following components by weight: 500 portions of coptis superfine powder, 50 to 150 portions of evodia superfine powder, 10 to 100 portions of effervescent disintegrant and 10 to 100 portions of disintegrant.

3. The coptis pharmaceutical composition according to claim 2, which consists of the following components by weight: 500 portions of coptis superfine powder, 50 to 150 portions of evodia superfine powder, 50 to 100 portions of effervescent disintegrant and 50 to 100 portions of disintegrant.

4. The coptis chinensis pharmaceutical composition as claimed in claim 1, wherein the mass ratio of the coptis chinensis superfine powder to the fructus evodiae superfine powder is 6: 1.

5. Use of the pharmaceutical composition of coptis chinensis as claimed in any one of claims 1 to 4 for the preparation of a medicament for treating gastric diseases, wherein the gastric diseases are those caused by helicobacter pylori.

6. The use of claim 5, wherein the gastric disorder is gastric cancer or gastric ulcer.

7. The use according to claim 6, wherein the medicament is a pill or tablet prepared from the Coptidis rhizoma pharmaceutical composition according to any one of claims 1-4 by itself, or a pill or tablet prepared from the Coptidis rhizoma pharmaceutical composition according to any one of claims 1-4 by mixing with pharmaceutical excipients to be added in a certain dosage form.

8. The use of claim 7, wherein the pellets are prepared by a process comprising: mixing Coptidis rhizoma micropowder and fructus evodiae micropowder of the Coptidis rhizoma pharmaceutical composition of any one of claims 1-4, adding aqueous solution of disintegrating agent and effervescent disintegrant, spraying, making pill, and drying.