CN102228551B

CN102228551B - Chinese medicinal composition for preventing and treating injury of gastric mucosa and preparation method thereof

Info

Publication number: CN102228551B
Application number: CN201110181724A
Authority: CN
Inventors: 王智森; 高飞
Original assignee: 王智森
Current assignee: Shijiazhuang Zangnuo Pharmaceutical Co., Ltd.
Priority date: 2011-06-30
Filing date: 2011-06-30
Publication date: 2012-09-26
Anticipated expiration: 2031-06-30
Also published as: CN102228551A

Abstract

The invention discloses a Chinese medicinal composition for preventing and treating injury of gastric mucosa and a preparation method thereof. The Chinese medicinal composition comprises the active ingredients prepared from the following Chinese medicines in part by weight: 24 to 65 parts of astragalus, 18 to 40 parts of Indian buead, 5 to 26 parts of Mongolian dandelion herb, 3 to 15 parts of medicinal evodia fruit, 3 to 21 parts of angelica dahurica and 0.5 to 9 parts of calcined oyster shell. The invention also provides a preparation containing the Chinese medicinal composition and a preparation method thereof. The Chinese medicinal composition for preventing and treating the injury of gastric mucosa has the effects of supplementing qi and tonifying spleen, clearing away heat and eliminating dampness and lowering adverse flow of qi and harmonizing stomach under the action of the medicines to achieve the effect of protecting the gastric mucosa. Experiments prove that the Chinese medicinal composition can be used for preventing and treating gastric mucosa diseases.

Description

A kind of Chinese medicine composition of preventing and treating gastric mucosa injury and preparation method thereof

Technical field

The present invention relates to a kind of Chinese medicine compound, be specifically related to Chinese medicine composition of a kind of prevention and treatment gastric mucosa injury and preparation method thereof.

Background technology

Gastric mucosa disease is modal a kind of disease in many gastropathy, and clinical manifestation is pantothenic acid, belch, feels sick, vomits or chronic after the meal middle Upper abdominal pain when serious melena and hematemesis to be arranged.Along with social life rhythm is accelerated and huge operating pressure, usually cause people's diet irregular, do not drink and do not eat or crapulent situation has generation frequently.People's dietary habit simultaneously, pica, reasons such as the pungent and excessive drinking of surfeit all are to cause the major incentive of gastric mucosa damage.According to statistics, U.S. gastrointestinal disease sickness rate male is 10%, and the women is 5%: Japan is 5-10%; Germany is 12.3%.China's gastrointestinal disease average attack rate is 11.43%.

The medical expert finds through a large amount of investigation in recent years; People between 20 to 40 years old; Only there is 47% gastric mucosa more normal; But this period is labour force the most prosperous and the most powerful period just, and it has well imagined to the influence that the mankind bring, so the gastric mucosa disease will become one of 21 century subject matter of being faced of human health.

The medicine of the treatment gastric mucosa injury that occurs in the market has antacid (sodium bicarbonate etc.), gastric mucosa protectant (bismuth potassium citrate etc.), and anti-helicobacter pylori medicine etc., but these drug side effectes are big, and be prone to recurrence, be prone to develop immunity to drugs.In recent years, Chinese herbal medicine relaxes, is difficult for producing drug resistance, characteristics such as is fit to take for a long time with its property of medicine, receives consumers in general's favor more and more deeply.Therefore, the present invention is raw material from cooking culture and traditional Chinese medical science traditional theory with the Chinese herbal medicine, in conjunction with theory of Chinese medical science, and reasonable compatibility, collaborative playing a role can better be brought into play the effect of protection gastric mucosa.

Summary of the invention

The object of the present invention is to provide a kind of to prevent and to treat Chinese medicine composition of gastric mucosa damage and preparation method thereof.

The Chinese medicine composition of control gastric mucosa damage provided by the invention contains the active component of being processed by following parts by weight of Chinese traditional medicine: Radix Astragali 24-65 part, Poria 18-40 part, Herba Taraxaci 5-26 part, Fructus Evodiae 3-15 part, Radix Angelicae Dahuricae 3-21 part, Concha Ostreae (calcined) 0.5-9 part.

Preferably, this Chinese medicine composition contains the active component of being processed by following parts by weight of Chinese traditional medicine: Radix Astragali 35-58 part, Poria 20-26 part, Herba Taraxaci 9-24 part, Fructus Evodiae 5-12 part, Radix Angelicae Dahuricae 5-12 part, Concha Ostreae (forging) 3-6 part.

Further preferred, this Chinese medicine composition contains the active component of being processed by following parts by weight of Chinese traditional medicine: 50 parts of the Radixs Astragali, 22 parts in Poria, 17 parts of Herba Taraxacis, 10 parts of Fructus Evodiaes, 10 parts of the Radixs Angelicae Dahuricae, 5 parts of Concha Ostreaes (forging).

The Chinese medicine composition of control gastric mucosa damage provided by the invention also contains pharmaceutically acceptable carrier or diluent.

Said Chinese medicine composition is peroral dosage forms such as tablet, pill, capsule, granule, preferred capsule.

The present invention also provides the method for the Chinese medicine composition for preparing above-mentioned control gastric mucosa injury, may further comprise the steps:

1) the various medicines with above-mentioned weight proportion screen respectively, pick, put in order;

2) with the direct crushing screening of medicine, add pharmaceutically acceptable carrier or diluent,, be prepared into various dosage forms according to the equivalent method mix homogeneously that progressively increases.

2) Radix Astragali, Poria, Herba Taraxaci, Fructus Evodiae are carried out water extraction, relative density was 1.30～1.35 when decoction liquor was concentrated into 60 ℃, and drying gets dry extract;

3) with step 2) dry extract that obtains pulverizes and sieves, and the Radix Angelicae Dahuricae, Concha Ostreae mix homogeneously with pulverizing add pharmaceutically acceptable carrier or diluent, according to the equivalent method mix homogeneously that progressively increases, are prepared into various dosage forms.

Further preferably, the method for preparing above-mentioned preparation may further comprise the steps:

1) the various medicines with above-mentioned weight proportion screen respectively, pick, put in order; 2) Radix Astragali, Poria, Herba Taraxaci, Fructus Evodiae are extracted:

Get the Radix Astragali, Poria, Herba Taraxaci, Fructus Evodiae decocte with water 2 times, add 10 times of water gagings at every turn, decocted 2 hours, filter and merge, decoction liquor, filtering residue discards, relative density was 1.30～1.35 when decoction liquor was evaporated to 60 ℃, vacuum drying, dry extract;

3) then with step 2) dry extract that obtains pulverized 100 mesh sieves, with the Radix Angelicae Dahuricae, the Concha Ostreae mix homogeneously of pulverizing, cross the 40-100 mesh sieve, added pharmaceutically acceptable carrier or diluent then, according to the equivalent method mix homogeneously that progressively increases, was prepared into various dosage forms.

The medicine material that the present invention adopts is described as follows:

The Radix Astragali: be the root of leguminous plant Radix Astagali, Radix Astragali.The sweet in the mouth slightly warm in nature is returned lung, spleen, liver, kidney channel, invigorating QI to consolidate the body surface resistance is arranged, effects such as expelling pus and promoting granulation.Its chemical constituent mainly contains glycoside, polysaccharide, aminoacid and trace element.Clinical research finds that with Radix Astragali injection intramuscular injection for treating gastric and duodenal ulcers, each cardinal symptom all has improvement in various degree after one week of medication.Has extremely strong antiulcer activity (Jia Shuqin, 1994) with astragalus root as the decoct of principal agent.Zhao Wei medium (1999) confirms that through mice ethanol property gastric mucosa injury model and the model experiment of rat pylorus ligation property gastric mucosa injury Radix Astragali essenc can reduce the gastric mucosa of animal damage index, has tangible gastric mucosal protective effect.Radix Astragali essenc can improve the gastric mucosal protective effect of H2 receptor antagonist cimetidine in addition, the prompting Radix Astragali essenc can with antiulcerative Combined application such as cimetidine treatment peptic ulcer.Wang Changhong etc. (1994) research compound astragalus membranaceus soup has the significant protection effect to gastric mucosa, has preventing or alleviates the effect of indometacin to rat pipe film injury.The pharmacopeia recommended amounts of the Radix Astragali is 9-30g/ day, and this product consumption is 3.0g/ day.

Poria: be the dry sclerotia of Polyporaceae fungus Poria.Sweet in the mouth, light, property are flat, GUIXIN, lung, spleen, kidney channel.Has promoting diuresis to eliminate damp pathogen, spleen invigorating, the effect of mind calming.Mainly contain polysaccharide, triterpene and other constituents (Li Ping etc., 2004).The experimental result that He Wei etc. (1995) drink to three kinds of experimental gastric ulcer rat oral gavages with Poria shows that Poria is drunk in the effect link of anti-gastric mucosa injury, and its barrier function that strengthens gastric mucosa is forced the inhibitory action of gastric acid secretion more important.A lot of in addition is the main prescription treatment gastroenteropathy of also preparing for the postgraduate qualifying examination with the Poria, is used for the treatment of gastric ulcer, (Yan Yongchao, 1995) evident in efficacy like the Poria decoction for Resuscitation.The pharmacopeia recommended amounts of Poria is 6-12g/ day, and this product consumption is 1.32g/ day.

Herba Taraxaci: be herb according to section's plant dandelion.Bitter but sweet flavor is cold in nature, returns liver, stomach warp, can heat-clearing and toxic substances removing, and dispersing swelling and dissipating binds, the impairment of YIN not though its flavor is bitter, though property is cold and do not upset one's stomach, can make damp and hotly clearly, the expectorant stasis of blood must be changed.The modern pharmacological research Herba Taraxaci contains multiple elements such as glucose, taraxacin, taraxol, inose, vitamin A, vitamin B, vitamin C; Helicobacter pylori is killed and inhibitory action; Can make the gastric mucosa injury reparation, inflammation is eliminated (Zhi Yuanlin, 1999).The pharmacopeia recommended amounts of Herba Taraxaci is 3-9g/ day, and this product consumption is 1.02g/ day.

Fructus Evodiae: be the dry almost ripe fruit of rutaceae Fructus Evodiae.Hot, bitter, hot.Return liver, spleen, stomach, kidney channel.Dispersing cold for relieving pain is arranged, effects such as stopping nausea and vomiting by lowering the adverse flow of QI.Wei Ning (2004) etc. discovers that the Fructus Evodiae water extract has tangible antiulcer action, finds that simultaneously Fructus Evodiae decoction can reduce the rat gastric secretion, and can reduce gastric acidity, embodies the protective effect to gastric mucosa.The pharmacopeia recommended amounts of Fructus Evodiae is 1.5-4.5g/ day, and this product consumption is 0.6g/ day.

The Radix Angelicae Dahuricae: be the dry root of the samphire Radix Angelicae Dahuricae.Suffering, temperature.Return stomach, large intestine, lung meridian.Discover that the Radix Angelicae Dahuricae has detumescence and pain relieving, granulation promoting with hold back the dual regulation therapeutical effect of infections, can eliminate swelling, healing ulcer, softening spot promotes the recovery of impaired gastric mucosa.Can ooze out through diminishing inflammation, eliminate swelling, promoting blood circulation to remove stagnancy, activating collaterals and eliminating stagnation; Removing dampness is let out turbid, and function of nervous system is regulated in the QI and blood regulating; Eliminating pathogenic factor for supporting vital QI, the peaceful network that stops blooding, softening inflammation fiber spot; Putrefaction-removing granulation-promoting, the number of ways of convergence ulcer and obtain the damaged ulcer (Shi Ping Wu etc., 1996) of treatment gastrointestinal mucosa.The pharmacopeia recommended amounts of the Radix Angelicae Dahuricae is 3-9g/ day, and this product consumption is 0.6g/ day.

Concha Ostreae (calcined): be the calcining product of the long oyster shell of Ostreidae animal.Become, be slightly cold.Return liver, gallbladder, kidney channel.Has the astringent or styptic treatment for spontaneous sweating effect of convergence, the treatment of the acid regurgitation that can be used for having a stomachache.Hu Qixing (1975) discovers, the function that Concha Ostreae has antacid, pain relieving, hemostasis, restrains, removes the rotten and lets fresh grow is that the compound oyster shell of principal agent looses peptic ulcer is had the obvious suppression effect with Concha Ostreae (forging).Nie Shuqin etc. (1994) discover; Concha Ostreae and Concha Ostreae (calcined) all have the effect of inhibition test gastric ulcer; It is active that wherein Concha Ostreae (calcined) can obviously improve anti-tentative gastric ulcer, simultaneously HCl type ulcer, dehydrated alcohol type ulcer and pylorus ligation ulcer had tangible preventive effect.The pharmacopeia recommended amounts of Concha Ostreae is 9-30g/ day, and this product consumption is 0.3g/ day.

In compound preparation, many all have the mutual compatibility between the Radix Astragali, Poria, Herba Taraxaci, Fructus Evodiae, the Radix Angelicae Dahuricae, the Concha Ostreae with the relevant compound recipe of protection gastric mucosa.Wang Changhong etc. (1994) discover, are that the compound astragalus membranaceus soup that main compatibility of drugs forms has the significant protection effect to gastric mucosa with the Radix Astragali, Herba Taraxaci.Discover the Poria decoction for Resuscitation treatment gastroenteropathy (Yan Yongchao, 1995) evident in efficacy that compatibility of drugss such as Poria and Fructus Evodiae form.Luo Changyi etc. (2000) are through clinical discovery, and the normal and Radix Astragali compatibility of the Radix Angelicae Dahuricae is got Radix Astragali QI invigorating and blood producing; Blood fills the merit of meat length, and the two combination brings out the best in each other; So the Huangqi Jianzhong Tang that compatibilities such as the clinical Radix Astragali commonly used, the Radix Angelicae Dahuricae form adds flavor treatment gastroenteropathy, curative effect is obvious.The Radix Bupleuri that forms with compatibilities such as Poria, Concha Ostreaes adds Os Draconis Concha Ostreae soup treatment peptic ulcer, (Zhang Guoan etc., 2000) evident in efficacy.The contained Radix Hemsleyae Macrospermae gastrointestinal ball that is used for treatments such as gastrointestinal tract inflammation, ulcer is formed by medical material compatibilities such as Radix Astragali 66g, Fructus Evodiae 33g in country's Chinese herbal medicine standard compilation internal medicine taste fascicle.

The Chinese medicine composition of control gastric mucosa injury provided by the invention has the following advantages: all medicines share, and play replenishing QI to invigorate the spleen, clearing away heat and eliminating dampness, normalizing the stomach by guiding QI downward effect altogether and reach the effect of protection gastric mucosa.Can prevent and treat gastric mucosa disease through evidence pharmaceutical composition provided by the invention.

The specific embodiment

Following examples are used to explain the present invention, but are not used for limiting scope of the present invention.

Embodiment 1:

1, form (weight):

Radix Astragali 50g, Poria 22g, Herba Taraxaci 17g, Fructus Evodiae 10g, Radix Angelicae Dahuricae 10g, Concha Ostreae (calcined) 5g.

2, method for preparing:

1) the various medicines with above-mentioned weight proportion screen respectively, pick, put in order, concoct;

2) Radix Astragali, Poria, Herba Taraxaci, Fructus Evodiae decocte with water are 2 times, add 10 times of water gagings at every turn, decoct 2 hours.Be evaporated to the clear paste that (0.065Mpa, 75 ℃) to relative density is 1.30～1.35 (60 ℃ of surveys);

3) concentrated solution carries out vacuum (0.085Mpa, 65 ℃) drying, gets dry extract, pulverizes 100 mesh sieves, gets fine powder A;

4) Radix Angelicae Dahuricae is ground into fine powder, crosses 100 mesh sieves; Concha Ostreae (forging) is pulverized, and crosses 80 mesh sieves, mix fine powder B;

5) mix A, B powder, add the dextrin of finished product preparation 9.1g, the magnesium stearate of 0.44g, mix homogeneously, encapsulated.

Embodiment 2: the extraction process parameter is confirmed

Based on summary, conclusion,, draft this preparation and operate as follows in conjunction with the production practical experience to documents and materials:

1) Radix Angelicae Dahuricae, Concha Ostreae (forging) beat powder and are used as medicine;

2) Radix Astragali, Poria, Herba Taraxaci, Fructus Evodiae water decoct, and filter, and filtrating is condensed into clear paste;

3) with above-mentioned aloof from politics and material pursuits drying under reduced pressure, pulverizing, mixing, granulation, granulate, filling, packing.

More specific for the part technical parameter that makes disintegrating process, extraction process, carried out the investigation of technological parameters such as flour extraction, solvent addition, extraction time, extraction time respectively.

1, disintegrating process is investigated

1.1 the angelica root disintegrating process is investigated: take by weighing three parts of the clean medical materials of the Radix Angelicae Dahuricae, each 100g after 60 ℃ of dryings, is ground into fine powder, crosses 100 mesh sieves, flour extraction is calculated in weighing, and the result sees table 1.

Table 1: the angelica root disintegrating process is investigated the result

Result of the test shows that the average flour extraction that the Radix Angelicae Dahuricae is pulverized is 95.1%, and flour extraction is more stable, has producing feasibility.Be used as medicine with the capacity fine powder in the preparation, with the accuracy that guarantees to feed intake.

1.2 Concha Ostreae (calcined) pulverizing medicinal materials technology is investigated: take by weighing three parts of the clean medical materials of Concha Ostreae (calcined), each 100g pulverizes, and crosses 80 mesh sieves, and flour extraction is calculated in weighing, and the result sees table 2.

Table 2: Concha Ostreae (forging) pulverizing medicinal materials technology is investigated the result

Result of the test shows that the average flour extraction that Concha Ostreae (calcined) is pulverized is 93.4%, and flour extraction is more stable, has producing feasibility, is used as medicine with capacity Concha Ostreae (calcined) powder in the preparation, with the accuracy that guarantees to feed intake.

2, the decocting extraction process is investigated

Confirming of test objective and performance assessment criteria: through multifactorial orthogonal test, the preferred parameters of whose extraction process.Promote cream yield and crude polysaccharides amount as performance assessment criteria, to select optimum process parameters with water.

Table 3: water is carried the experimental factor water-glass

In order to investigate the technological parameter of water extraction, we select L9 (34) orthogonal test:

Test method and result: take by weighing Radix Astragali 50g, Poria 22g, Herba Taraxaci 17g, Fructus Evodiae 10g respectively, amount to 99g, be divided into 9 parts, 1～9 tested number of randomization numbering.For decocting number of times, amount of water and decocting time, on the basis of above-mentioned factor, each factor designs 3 levels according to the principal element that influences water boiling and extraction, and factor and level see Table 4.Make an experiment by each tested number requirement among the orthogonal table L9 (34), filter, filtrating concentrates and is settled to certain volume, supplies test (dried cream yield, crude polysaccharides assay) to use.

2.1 the mensuration of dried cream yield: measure reserve liquid 100ml, put in the exsiccant evaporating dish, water bath method behind the vacuum drying, is weighed rapidly, is calculated as follows dried cream yield, and the result sees table 3.

Table 3: water is carried L ₉(3 ⁴) orthogonal table and orthogonal experiments

2.3.2 the assay of crude polysaccharides (with reference to Wang Guangya chief editor's " health food functional component detection method ")

1) instrument: UV-7504 ultraviolet-uisible spectrophotometer (Xinmao Instrument Co., Ltd., Shanghai); Centrifuge (Anting Scientific Instrument Factory, Shanghai); Constant water bath box (big Yongxing Instr Ltd. of Beijing section)

2) reagent:

Dextran standard (west, Shanghai precious biosphere Science and Technology Ltd. provides);

All the other reagent are analytical pure: water is distilled water;

Alcoholic solution (80%): add dehydrated alcohol 80ml, mixing in the 20ml water; Sodium hydroxide solution (100g/l): weighing sodium hydroxide 100g is dissolved in water and is diluted to 1L, adds solid water-free sodium sulfate to saturated, subsequent use; DDTC storing solution: take by weighing 3.0g CuSO ₄5H ₂O, the 30.0g sodium citrate is dissolved in water and is diluted to 1L, and mixing is subsequent use; DDTC solution: get DDTC storing solution 50ml, add water 50ml, add solid sodium sulfate 12.5g behind the mixing and make its dissolving.Face with newly joining; Detergent: water intaking 50ml adds DDTC solution 10ml, sodium hydroxide solution 10ml, mixing; Sulfuric acid solution (10%): get concentrated sulphuric acid 100ml and join in the water of the 800ml left and right sides, mixing is diluted to 1L after the cooling; Phenol solution (50g/L): take by weighing purifying phenol 5.0g, be dissolved in water and be diluted to 100ml, mixing.Solution is put the refrigerator mesochite and was preserved 1 month.

3) preparation of glucosan standard reserving solution:

It is fixed to take by weighing the accurate title of the dextran standard 0.5g that is dried to constant weight, is dissolved in water, and is settled to 50ml, and mixing is put in the refrigerator and preserved.This solution 1ml contains the 10.0mg glucosan.

4) the glucosan standard is used the preparation of liquid:

Draw glucosan standard reserving solution 1.0ml, place the 100ml volumetric flask, add water to scale, mixing is put in the refrigerator and is preserved.This solution 1ml contains glucosan 0.10mg.

5) drafting of standard curve

Accurately absorption glucosan titer 0,0.10,0.20,0.40,0.60,0.80,1.00ml (being equivalent to glucosan 0,0.01,0.02,0.04,0.06,0.08,0.10mg) place the 25ml color comparison tube respectively, and accurately supplementing water adds 50g/L phenol solution 1.0ml to 2.0ml; Mixing; Add concentrated sulphuric acid 10.0ml, careful mixing is put and is boiled 2min in the boiling water bath; The cooling back uses spectrophotometer to be reference in the 485nm wavelength with blank reagent solution, and the 1cm cuvette is measured absorbance.With glucosan concentration is abscissa, and absorbance is a vertical coordinate, the drawing standard curve.

6) preparation of sample solution

Precision is measured medicinal liquid 2.0ml, puts in the 50ml centrifuge tube, adds dehydrated alcohol 20ml, and behind the mixing 5min, with 3000r/min repeatable operation 3～4 times, residue is with water dissolution and be settled to 5.0ml, mixing.Precision is measured filtrating 2ml and is placed the 20ml centrifuge tube, adds 100g/L sodium hydroxide solution 2.0ml, DDTC solution 2.0ml, boils 2min in the boiling water bath, cooling; With the centrifugal 5min of 3000r/min, abandoning supernatant, residue is with milliliter washing of cleaning mixture number; Centrifugal back abandoning supernatant, repeatable operation 3 times, residue dissolves with 10% (volume fraction) sulfuric acid solution 2.0ml and is transferred in the 50ml volumetric flask; Thin up is to scale, and mixing promptly gets.

7) algoscopy: accurately draw sample determination liquid 2.0ml and place the 25ml color comparison tube, add 50g/L phenol solution 1.0ml, mixing; Add the careful mixing of concentrated sulphuric acid 10.0ml; Put and boil 2min in the boiling water bath, be cooled to room temperature, with spectrophotometer in the 485nm wavelength; With the reagent blank is reference, and the 1cm cuvette is measured absorbance.Find beta-dextran content from standard curve, crude polysaccharides content in the calculation sample, the result sees table 4.

Table 4: water is promoted cream yield and the variance analysis of crude polysaccharides amount

F _{005 (22)}=19.0, F _{0.01 (22)}=99.0 (the D value is empty row, does not have data, works to reduce error)

Can be known by The results of analysis of variance in result of the test and the table 6 in the table 5, serve as when investigating index with dried cream yield, A ₃＞A ₂＞A ₁, B ₃＞B ₂＞B ₁, C ₃＞C ₂＞C ₁, A, B, each factor affecting of C are followed successively by C＞A＞B, and wherein the C factor affecting is the most remarkable, and significant difference is arranged; A, B factor affecting are less, and there was no significant difference is so optimised process is A ₃B ₃C ₃

With crude polysaccharides content serves as when investigating index, A ₃＞A ₂＞A ₁, B ₃＞B ₂＞B ₁, C ₂＞C ₃＞C ₁, A, B, each factor affecting of C are followed successively by C＞A＞B, and wherein the C factor affecting is the most remarkable, and significant difference is arranged; A, B factor affecting are less, and there was no significant difference is so optimised process is A ₃B ₃C ₂

Take all factors into consideration: the purpose of this technology is intended to extract effective ingredient in the medical material, dwindles the volume of preparation, reduces dose, and simultaneously from reducing cost, energy savings and enhance productivity and set out confirms that the decocting part optimum process condition of this technology is A ₃B ₃C ₂, promptly taking by weighing medical material, decocte with water 2 times adds 10 times of water gagings at every turn, decocts 2 hours.

2.4 selection process demonstration test: take by weighing Radix Astragali 50g, Poria 22g, Herba Taraxaci 17g, Fructus Evodiae 10g respectively, amount to 99g, parallelly be divided into 3 parts; According to the process conditions of screening, decocte with water 2 times adds 10 times of water gagings at every turn; Decocted 2 hours, and filtered merging filtrate; Filtrating concentrating is settled to certain volume, supplies test (dried cream yield, crude polysaccharides assay) to use.Test method is extracted quadrature with reference to decocting and is investigated item method down, and result of the test sees Table 7.

Table 7: decocting extracts the demonstration test result

The checking result shows that it is 22.16% that decocting extracts average dried cream yield, and the crude polysaccharides average content is 1.122g; The highest i.e. the 9th comparison of crude polysaccharides content in demonstration test result and the orthogonal table, so crude polysaccharides content and the 9th basically identical are this technology basic feasible solution; So confirm that extraction process by water is A3B3C2; Be decocte with water 2 times, add 10 times of water gagings at every turn, decocted 2 hours.

3, separation and purification

Medical material is after water boiling and extraction, and what obtain is medicinal residues, precipitate, other solid impurity and the mixture that contains the extracting solution of active ingredient, for effectively removing impurity, reduces dose, and aqueous extract adopts 200 mesh sieves to filter.

4, concentrate

For preventing that effective ingredient receives heat damage for a long time; Adopt concentrating under reduced pressure equipment to concentrate; According to the character and the operating condition of medicine, confirm with the aqueous extract concentrating under reduced pressure (0.065～-0.075Mpa, 75 ℃) be the clear paste of 1.30～1.35 (60 ℃ of surveys) to relative density.

5, dry, pulverizing

Above-mentioned water is put forward clear paste vacuum (0.085Mpa, 65 ℃) drying, and the inventory that control simultaneously is dried is overflowed outside the dish in case material bubbles.Vacuum drying: be in airtight container, to carry out exsiccant method behind the vacuumizing, its decapacitation adds speed, reduces outside the temperature, can also make exsiccant material loosen, be easy to pulverize.Obtain dry extract after the drying, dry extract obtains dried cream powder after pulverizing.

Embodiment 3: safety is investigated

1, material

1.1 experiment medicine: according to the medicine of embodiment 1 preparation, the yellow Pu Indian buead capsule of called after is perhaps tried thing, is provided by Shijiazhuang Cangnuo Biological Technology Co.,Ltd, and content is brown granular and powder.Adult's recommended amounts every day is 2100mg/60kg.BW.

1.2 laboratory animal: Kunming mouse and SD rat are provided production licence number by Sichuan Academy of Medical Sciences institute of lab animals: SCXK (river) 2004-16.SPF level.

2, test method

2.1 large and small Mus acute toxinology experiment:

Adopt each 20 of Kunming mouse and SD rats respectively, male and female half and half, mice body weight 18-22g, rat body weight 180-220g, large and small Mus is divided into two groups respectively at random, and 10 every group, male and female half and half.Test is established dose groups of 15000mg/kgBW by the maximum tolerated dose method.Taking by weighing 75g is tried behind thing adding distil water to the 200ml mixing subsequent use.Large and small Mus is all irritated stomach by twice per os of 20ml/kgBW and is tried thing, gap 4h.Irritate the preceding animal fasting 16h of stomach, do not limit drinking-water, observe poisoning symptom and the death condition of animal in 14 days, during off-test, weigh, put to death animal, do gross anatomy.

2.2 genetic toxicity test:

2.2.1Ames test: use and induce male rat liver S through Polychlorinated biphenyls (Aroclor 1254) ₉, be mixed with S by standard method ₉As activation system, (20 μ g/ ware 2-aminofluorenes are used for TA with indirect mutagen after the mixed liquor ₉₇, TA ₉₈, TA ₁₀₀, 50 μ g/ wares 1, the 8-dihydroxyanthraquinone is used for TA ₁₀₂Bacterium) measures the S9 activity.TA is adopted in test ₉₇, TA ₉₈, TA ₁₀₀, TA ₁₀₂Four kinds of bacterial strains are tried thing and are established five dose groups of 8,40,200,1000,5000 μ g/ wares and solvent control group (distilled water), spontaneous matched group and positive controls.At first preparation is tried the thing working solution: accurately take by weighing 5.0g and tried thing; Adding distil water is to 100ml, and mixing is high workload concentration 50mg/ml; Get this working solution 100 μ l during test and add plate; Be the highest thing final concentration (5000 μ g/ ware) that tried, with the highest to be tried the thing final concentration be the basis with 5 times of distilled water both down dilute following concentration, high pressure steam sterilization.Adding and do not adding S ₉Experimental condition under carry out flat board and mix method test.Make three parallel wares for every group, repeated trials once.-S ₉Positive control: TA ₉₇And TA ₉₈4-nitroquinoline-N-oxide with 0.5 μ g/ ware; TA ₁₀₀1.5 the Hydrazoic acid,sodium salt (NaN of μ g/ ware ₃); TA ₁₀₂Ametycin (MMC) with 1.0 μ g/ wares; + S ₉Positive control TA ₁₀₂With 1 of 50 μ g/ wares, 8-dihydroxyanthraquinone, its excess-three bacterial strain adopt the 2-aminofluorene (2-AF) of 20 μ g/ wares.The volume that every ware adds positive control is 0.1ml.

2.2.2 PCEMNR micronucleus test: adopt 50 of Kunming mouses; Body weight 20-30g; Male and female half and half; Test group is established 2500mg/kgBW, 5000mg/kgBW, three dose groups of 10000mg/kgBW, other establish solvent (distilled water) contrast and cyclophosphamide positive controls (CP, 40mg/kgBW).Take by weighing 2.5g, 5.0g, 10.0g and tried thing and 0.04gCP, adding distil water to 20ml mixing gets final product respectively.Irritate the long-pending 20mg/kgBW, two minor tick 24h of pressing of body of stomach.

Put to death animal in taking off cervical vertebra to 6h after being tried thing for the second time; Get the breastbone marrow and carry out film-making by regulation in " health food check and assessment technique standard " (2003) year version; Fixing; After the Giemsa dyeing; Under oily mirror, contain the micronucleus cell number in every mouse 1000 polychromatic erythrocytes of counting (PCE), calculate the permillage of micronucleus.Observe the ratio (PCE/NCE) of polychromatic erythrocyte and mature erythrocyte in 200 erythrocyte.

2.2.3 mouse sperm deformity test: adopt 25 of male mouse of kunming; Body weight 25-30g; Mice is divided into 5 groups at random, every group of 5 animals, 2500mg/kgBW, 5000mg/kgBW, three dose groups of 10000mg/kgBW are established in experiment; Other establish solvent (distilled water) contrast and cyclophosphamide positive controls (CP, 60mg/kgBW).Taking by weighing 2.5g, 5.0g, 10.0g is tried thing adding distil water to 20ml mixing and is got final product.Irritate the long-pending 20mg/kgBW that presses of body of stomach, every day, per os was irritated stomach once, continuous irrigation stomach 5 days.

In give first tried thing after the 35th day; Taking off cervical vertebra puts to death animal and gets the bilateral epididymis and carry out film-making; By the regulation in " health food check and assessment technique standard " (2003) year version, methanol is fixed, after the dyeing of 1% Yihong; 1000 complete sperms of every animal counting under high power lens, record sperm deformity, lopsided type and calculating rate of teratosperm.

2.330 it feeding trial: select 80 of ablactation SD rats for use; Male and female half and half; Body weight is 67-73g, and 875mg/kgBW, 1750mg/kgBW, three dose groups of 3500mg/kgBW (be equivalent to respectively human body recommended intake 25,50,100 times) are established in test, and other establishes the normal feedstuff matched group; Every group of 20 rats, male and female half and half.

Test is adopted and is mixed feeding, and converting in 10% of rat body weight is food-intake, and configuration contains the 15kg feedstuff that is tried thing 0.875%, 1.75%, 3.50% respectively.Take by weighing 131.25g, 262.5g, 525g and tried thing, join successively in the 3kg feedstuff earlier, fully behind the stirring and evenly mixing, more last feedstuff is added wherein, once more fully behind the stirring and evenly mixing, machine-shaping, dry for standby.The single cage ad lib of every rat every day, continuous 30 days, general performance, behavior, poisoning symptom and the death condition of observing animal every day were calculated food-intake weekly twice, and claimed body weight one time, according to food intake dose, calculated food utilization.

After the off-test, through femoral artery sacrificed by exsanguination animal, and blood sampling; Measure hematological indices with conventional method, mark the test kit that good Science and Technology Ltd. provides, measure blood biochemistry index with CX4 type automatic clinical chemistry analyzer and Guangzhou that U.S. Beckman Coulter Inc. produces; Dissect animal and observe the internal organs change; Claim that liver,kidney,spleen, testis are heavy, calculate its dirty body ratio, get liver,kidney,spleen, gastrointestinal, testis (ovary) and make histopathological examination.Duration of test animal ad lib, drinking-water.

3, test data statistics: the PCEMNR micronucleus test adopts X 2 test, and rank test is adopted in the mouse sperm deformity test, and the feeding trial data were through the variance test of homogeneity in 30 days; Variance is neat; Carry out variance analysis, less than 0.05, then compare in twos with the Dunnett method like the P value; Uneven, then carry out data transaction, still uneven, use rank test instead, less than 0.05, then use Dunnet ' s T3 method to compare in twos like the P value, above-mentioned statistics is all used the SPSS11.0 software processes.

4, result

4.1 acute toxinology experiment: the results are shown in Table 1

Table 1: yellow Pu Indian buead capsule is to large and small Mus acute oral toxicity test result

Can be found out by table 1: give general performance and the equal no abnormality seen of behavior tried large and small Mus behind the thing, do not see animal dead in the observation period, yellow Pu Indian buead capsule all greater than 15000mg/kgBW, belongs to nontoxic by the acute toxicity classification to large and small Mus acute oral MTD value.

4.2 genetic toxicity test

4.2.1Ames test: the result sees table 2 and table 3.

Table 2: yellow Pu Indian buead capsule Salmonella reversion test result (for the first time)

Annotate: above result is the means standard deviation of 3 plates

Table 3: yellow Pu Indian buead capsule Salmonella reversion test result (for the first time)

Annotate: above result is the means standard deviation of 3 plates

By visible in table 2, the table 3: compare with solvent control group; No matter adding or do not adding under the S9 condition; Average the returning of yellow each dose groups of Pu Indian buead capsule becomes the bacterium colony number average not above two times; And average the returning of positive controls becomes the bacterium colony number average above more than two times, presents obvious positive reaction, and The above results shows: Huangpu Indian buead capsule does not induce four kinds of bacterial strains to return the change clump count to be increased.

4.2.2 the PCEMNR micronucleus test: the result sees table 4.

Table 4: yellow Pu Indian buead capsule micronucleus test result

Annotate: compare with negative control group, ^*P＜0.01.

Can find out from table 4: compare with negative control group, the micronucleus permillage of the male and female Mus of three dose groups of yellow Pu Indian buead capsule there are no significant difference (P＞0.05), the cyclophosphamide positive controls then significantly increases (P＜0.01).The result surface: yellow Pu Indian buead capsule does not bring out the PCEMNR micronuclear rates and increases.

4.2.3 the mouse sperm deformity test: the result sees table 5.

Table 5: yellow Pu Indian buead capsule is to the mouse sperm deformity result of the test

Annotate: compare with negative control group, ^*P＜0.01.

Can find out from table 5: compare with negative control group, each dose groups rate of teratosperm there was no significant difference (P＞0.05) of yellow Pu Indian buead capsule, the cyclophosphamide positive controls then significantly increases (P＜0.01).It is main that the sperm deformity type mainly shows with unsetting, Wugou.The above results shows: yellow Pu Indian buead capsule is tried thing and is not brought out the mouse sperm deformity rate and increase.

4.3 30 days feeding trials of rat:

The duration of test animal health condition is good, the body weight sustainable growth, every group give yellow Pu Indian buead capsule after each treated animal poisoning symptom does not all appear, also do not see animal dead yet.

4.3.1 yellow Pu Indian buead capsule is to the influence of rat body weight: the results are shown in Table 6

Table 6: yellow Pu Indian buead capsule is to the influence

of rat body weight

Visible by table 6: compare the body weight there was no significant difference (P＞0.05) of the initial body weight of three dose groups male and female of yellow Pu Indian buead capsule rat, 1-4 week body weight and the 30th day with matched group.

4.3.2 yellow Pu Indian buead capsule is to the rat influence of food-intake weekly: the result sees table 7

Table 7: yellow Pu Indian buead capsule is to the rat influence of food-intake weekly

Visible by table 7, compare the food-intake weekly of three dose groups male and female of yellow Pu Indian buead capsule rat there are no significant difference (P＞0.05) with matched group.

4.3.3 yellow Pu Indian buead capsule is to the influence of rat food utilization

Table 8: yellow Pu Indian buead capsule is to the influence

of rat food utilization

Visible by table 8: compare food utilization weekly of three dose groups male and female of yellow Pu Indian buead capsule rat and total foodstuff utilization rate there are no significant difference (P＞0.05) with matched group.

2.3.4 the influence that yellow Pu Indian buead capsule is learned rat blood: the results are shown in Table 9.

Table 9: yellow Pu Indian buead capsule is learned the influence

of index to rat blood

Visible by table 9, compare the hematological indices of three dose groups male and female of yellow Pu Indian buead capsule rat there are no significant difference (P＞0.05) with matched group (dosage is 0 group).

4.3.5 yellow Pu Indian buead capsule is to the biochemical influence of rat blood in latter stage

Visible by table 10; Compare with matched group, the latter stage of three dose groups of yellow Pu Indian buead capsule, the dose groups glutamic oxaloacetic transaminase, GOT significantly reduced (P＜0.05) in rarely seen male Mus among the blood biochemistry detection result; Glutamic oxaloacetic transaminase, GOT reduces no physiological significance, and institute's measured value is in this chamber in normal range; There are no significant for all other index differences (P＞0.05), and institute's measured value is in this chamber range of normal value.

4.3.6 yellow Pu Indian buead capsule is to the influence of the dirty body ratio of rat

The result sees table 11, compare with matched group, the liver bodies of three dose groups male and female rats than, spleen body than the testis body ratio of, kidney body ratio and male Mus there are no significant difference (P＞0.05).

4.3.7 pathological examination: the results are shown in Table 12-18.

Put to death animal after the off-test, carry out gross anatomy, the naked eyes no abnormality seen changes.

The histopathological examination result shows: matched group has the interior slight cell infiltration of matter between 1 routine hepatic tissue; Yellow Pu Indian buead capsule high dose group has 1 routine hepatic tissue portal area inflammatory cell slightly to soak into; Abovely find to be the spontaneous pathological changes of animal, do not see that yellow Pu Indian buead capsule high dose group causes that the animal toxic injury changes.

Table 12: yellow Pu Indian buead capsule is to histology's influence of rat liver

Pathological changes (example)	Blank group N=20	High dose group N=20
			By membrane change	0	0
Hepatic congestion, edema	0	0
			It is downright bad that lobules of liver is dispersed in a ring	0	0
It is downright bad that lobules of liver is dispersed in the special mess shape	0	0
			Lobules of liver hydropic degeneration, acidophilia become	0	0
Proliferation of fibrous tissue, little bile duct proliferation	0	0
			The slight steatosis of lobules of liver	0	0
Liver portal area inflammatory cell infiltration	1	1
			Extramedullary hemopoiesis	0	0

Table 13: yellow Pu Indian buead capsule is to histology's influence of rat kidney

Pathological changes (example)	Blank group N=20	High dose group N=20
			By membrane change	0	0
Messangial cell hypertrophy, degeneration, cell infiltration	0	0
			Cast in tubular degeneration, necrosis, the renal tubules	0	0
Glomerule hyaline degeneration, sclerosis	0	0
			The focal cell infiltration of matter, fibroplasia between kidney	0	0
Focal renal tubules, collecting tubule expansion	0	0
			Focal renal tubular cell degeneration, collecting tubule cytopathy	0	0
The degeneration of renal calices mucosa, mucosa undertissue cell infiltration, fibroplasia	0	0
			Simple cyst	0	0

Table 14: yellow Pu Indian buead capsule is to histology's influence of Rats Spleen

Pathological changes (example)	Blank group N=20	High dose group N=20
			Red pulp expansion, proliferation of fibrous tissue	0	0
The acini lienalis atrophy	0	0
			Pigmentation	0	0
Snius lienis expansion, congested, cell infiltration	0	0
			The macrophage hypertrophy	0	0
Granuloma forms	0	0
			Lymphadenosis	0	0
Extramedullary hemopoiesis	0	0

Table 15: yellow Pu Indian buead capsule is to histology's influence of rat stomach

Pathological changes (example)	Blank group N=20	High dose group N=20
			Mucous epithelium degeneration, necrosis	0	0
The mucous epithelium intestinalization	0	0

Pigmentation	0	0
			The lamina propria cell infiltration	0	0
The lamina propria body of gland reduces	0	0
			Lamina propria body of gland hyperplasia	0	0

Table 16: yellow Pu Indian buead capsule is to histology's influence of jejunum in rats

Table 17: yellow Pu Indian buead capsule is to histology's influence of rat testicle

Table 18: yellow Pu Indian buead capsule is to histology's influence of rat ovary

5, test brief summary

5.1 yellow Pu Indian buead capsule is pressed the acute toxicity classification to large and small Mus acute oral toxicity test MTD＞15000mg/kgBW as a result, belongs to nontoxic level.

5.2 three genetic toxicity tests (Salmonella reversion test, PCEMNR micronucleus test and mouse sperm deformity test) result does not see yellow Pu Indian buead capsule mutagenic action.

5.330 it feeding trial, visible animal growth is normal, the body weight sustainable growth; The figure is active; Smooth submissive by hair, large and small just no abnormality seen changes, and rat blood is learned conventional sense and blood biochemistry index check in latter stage and other each item indexs all in range of normal value.The histopathological examination result except that the spontaneous pathological changes of animal, does not see that being tried the object height dose groups causes that the animal toxic injury changes.

Embodiment 4: to the defencive function-zoopery of gastric mucosa damage

1, material

1.1 experiment medicine:

The medicine of embodiment 1 preparation, the yellow Pu Indian buead capsule of called after is provided by Shijiazhuang Cangnuo Biological Technology Co.,Ltd, content system brown granular and powder, human body recommended amounts every day is 2.1g/60kgBW; Do the solvent configuration with distilled water and tried thing;

1.2 laboratory animal: 48 of the SD male rats that provides by Sichuan Academy of Medical Sciences institute of lab animals, body weight 160-180g, experimental animal room is the SPF level, temperature 20-25 ℃, relative humidity 40-70%.

1.3 dosage is selected: yellow Pu Indian buead capsule is established 175mg/kgBW, 525mg/kgBW, three dose groups of 1050mg/kgBW (be equivalent to respectively human body recommended amounts 5,15,30 times).Take by weighing 4.375g, 13.125g, the yellow Pu Indian buead capsule of 26.25g respectively, adding distil water is to 250mL successively, and fully behind the mixing, refrigerator is preserved.

2, experimental technique: the acute gastric mucosal lesion modelling is adopted in experiment:

Give the tried thing of various dose by the 10mL/kgBW per os rat every day of three dose groups, and the blank group gives distilled water.Continuous irrigation stomach 30 days is claimed body weight weekly one time, and stomach dosage is irritated in adjustment.The animal fasting can't help water 24 hours before dissecting.

Experiment finishes the thing that tried of each dose groups filling stomach various dose group on the same day and only irritates stomach dehydrated alcohol 1.0mL/ after 1 hour again; Put to death animal after 1 hour; Get stomach, fixing after 20 minutes in 10% formalin, the stomach after fixing is cut off clean gastric content along greater gastric curvature; Gastric mucosa is launched, with vernier caliper measurement gastric mucosa injury area.

3, data statistics: adopt SPSS 11.0 software processes.Statistical method is with the statistical method of feeding experiment in 30 days among the embodiment 3.

4, result

4.1 yellow Pu Indian buead capsule is to the influence of rat body weight

Table 1: yellow Pu Indian buead capsule is to the influence

of rat body weight

Visible by table 1, compare with the blank group, give initial body weight, the mid-term body weight and finish body weight there was no significant difference (P＞0.05) of three dose groups animals of yellow Pu Indian buead capsule.

2.2 yellow Pu Indian buead capsule is to the influence of rat stomach mucosa injury area:

Table 2: yellow Pu Indian buead capsule is to the influence

of rat stomach mucosa injury area

Dosage (mg/kgBW)	Number of animals (only)	Impaired area (the mm of gastric mucosa ²)	P
				0	12	356.43±171.83
175	12	238.89±109.28	0.291
				525	12	136.28±101.08	0.007
1050	12	54.01±28.22	0.001

Visible by table 2; Compare with the blank group, three dose groups of yellow Pu Indian buead capsule are to the caused rat pipe film injury area of dehydrated alcohol, and the low dose group damaged area reduces; But no difference of science of statistics (P＞0.05), middle and high dose groups then have significant difference (P＜0.01).

4, conclusion:

Yellow Pu Indian buead capsule behind 30 days continuous per os filling stomach SD male rats, its well-grown, body weight sustainable growth.Can significantly reduce middle and high dose groups animal because of the caused rat acute gastric mucosa injury of dehydrated alcohol area.Thus decidable this tried thing gastric mucosa damage had assistant protection function, the result is positive.

Embodiment 5: to the assistant protection function-human feeding trial of gastric mucosa injury

1, material

1.1 sample: according to the product of embodiment 1 preparation, yellow Pu Indian buead capsule is produced by medical bioengineering production base, three former magnificent states, every net weight 0.35g, the human body recommended amounts is: every day 2 times, each 3, promptly every day 2.1g.

1.2 experimenter crowd: select to meet criterion person by the principle of voluntariness and participate in human feeding trial as the experimenter.

1.2.1 experimenter's choice criteria

1.2.1.1 meet the chronic superficial gastritis diagnostic criteria and make a definite diagnosis through gastroscope.The chronic superficial gastritis diagnostic criteria: course of disease delay, clinical symptoms such as in various degree dyspepsia, upper abdominal pain, heartburn, belch, acid regurgitation, abdominal distention are arranged, the epigastrium mild tenderness can be arranged.Meet diagnostic criteria of chronic superficial gastritis fibergastroscope and biopsy diagnostic criteria, and get rid of the gastric ulcer person.

1.2.1.2 age 18-65 year.

1.2.2 experimenter's exclusion standard

Age is under-18s or over-65s person;

Gestation or women breast-feeding their children, allergic constitution reaches this sample allergy sufferers;

The Secondary cases chronic gastritis;

Be associated with serious general disease such as cardiovascular, cerebrovascular, liver, kidney and hemopoietic system and psychotic;

Clinical symptoms total mark＞12 minute person, sign are classified as serious symptom person;

Often medication, be addicted to drink, a large amount of smoker;

The patient that digestive system and ulcer is arranged;

Taking the other treatment medicine or accepting the other treatment person;

Take the article relevant in a short time, have influence on judgement person the result with being tried function;

Edible in accordance with regulations given the test agent can't be judged effect or data not umbra sound effect or security judgement person.

1.3 key instrument

Gastroscope: the Japanese Pan Tai product main frame EMP-3000 of company, gastroscope 290P.

2, EXPERIMENTAL DESIGN and divide into groups to require: the no organic diseases of 110 examples, the chronic superficial gastritis volunteer that meets the standard of including in are divided into two groups at random; Test-meal group, each 55 example of matched group; The test-meal group is taken yellow Pu Indian buead capsule, and matched group is taken placebo, and be 30 days observing time.Placebo outward appearance, color and luster, weight are identical with yellow Pu Indian buead capsule.The duration of test normal diet, do not change original dietary habit.

Before the test, harmonious check between test-meal group and matched group organized, wherein age, sex, course of disease there was no significant difference (P＞0.05) relatively.The experimenter adopts the method for contrast between own control and group, before and after relatively the test-meal group is tested, and the variation of clinical symptoms integration, sign integration, gastroscope review result.

2.1 instructions of taking: consumption and time: everyone each 3 of experimenters, every day 2 times, warm water takes, and duration of test does not change original dietary habit, normal diet, and all article close of stopping using with these article function, be 30 days observing time.

2.2 observation index:

2.2.1 safety indexes: ordinary circumstance: the experimenter is mental status, diet situation, sleep, defecation, blood pressure etc. during test-meal.

2.2.2 inspection index:

Blood routine inspection: hemoglobin, erythrocyte, numeration of leukocyte;

Routine urinalysis: urine protein, glucose in urine, little fecal occult blood, urine erythrocyte, UBG;

Stool routine; Biochemical indicator comprises glutamic oxaloacetic transaminase, GOT, glutamate pyruvate transaminase, total protein, albumin, blood urea nitrogen, creatinine, T-CHOL, triglyceride, fasting glucose.

Inspection Chest X-rays, electrocardiogram and Abdominal B type ultrasonography before on-test.

2.2.3 effect property index: inspection during with on-test and end.

2.2.4 observation of symptoms: according to clinical symptoms weight statistics integrations such as stomachache, belch, acid regurgitation, abdominal distention, inappetence, few foods.

2.2.5 sign is observed: according to tenderness degree record experimenter sign integration under the xiphoid-process.

2.2.6 gastroscopic observation: each 15 example of test-meal group and matched group, the experimenter carries out gastroscope check, the situation of change before and after the viewing test when off-test.

3, date processing: all own control data can adopt paired t-test; Two groups of means relatively adopt t check in groups; The latter need carry out homogeneity test of variance; The data of nonnormal distribution or heterogeneity of variance are carried out the conversion of suitable variable, wait to satisfy the normal state variance neat after, carry out the t check with data converted; If translation data still can not satisfy the neat requirement of normal state variance, use t check or rank test instead; But the coefficient of variation too data of big (like CV＞50%) is used rank test.

4, the result judges

Test-meal group self relatively compares between test-meal group and matched group group after the test-meal before and after the test-meal, and clinical symptoms, sign integration obviously reduce, and the gastroscope review result has improvement or do not increase the weight of, and this given the test agent of decidable has assistant protection function to gastric mucosa injury.

5, result

5.1 ordinary circumstance

5.1.1 test-meal group and matched group sex, age and the course of disease are relatively

Off-test is because of failing to adhere to taking this product ablation experiment person 10 examples, and wherein test-meal group and control group be 5 examples respectively, and this tests 100 examples actual completion, the results are shown in Table 1.

Table 1: test-meal group and matched group sex, age course of disease situation are relatively

Each 50 example of test-meal group and matched group.Sex, age, course of disease comparing difference do not have significance (P＞0.05) between two groups, have comparability.

5.1.2 test preceding two groups of experimenter's Chest X-rays, Abdominal B type ultrasonography, the equal no abnormality seen of electrocardiogram.Two groups of experimenter's defecation of duration of test, blood pressure, spirit, diet, sleep are no abnormal.

5.2 safety observation index

5.2.1 routine blood test and blood biochemistry index situation of change before and after the test

Table 2: the routine blood test situation compares

before and after two groups of tests

Table 3: the biochemical indicator situation compares

before and after two groups of tests

From table 2,3 visible, relatively erythrocyte, numeration of leukocyte, content of hemoglobin, glutamate pyruvate transaminase, glutamic oxaloacetic transaminase, GOT, total protein, albumin, T-CHOL, triglyceride, blood glucose, blood urea nitrogen, creatinine all were in normal range before and after the experimenter tested.

5.2.2 routine urinalysis, stool routine situation of change before and after the test: routine urinalysis before and after two groups of experimenters test, stool routine is checked equal no abnormality seen.

5.3 effect property index

5.3.1 symptom, sign integration situation are relatively before and after two groups of tests

Visible by table 4:

1) tests preceding each clinical symptoms integration, total symptom integral, sign integration there was no significant difference (P＞0.05) for two groups;

2) self compare before and after the test-meal group test, each clinical symptoms integration, total symptom integral, sign integration obviously reduce, and difference has significance (P＜0.01).

3) compare test-meal group and matched group test back, and stomachache in each clinical symptoms of test-meal group, belch, abdominal distention, acid regurgitation, few food stagnation branch obviously are lower than matched group, and difference has highly significant property (P＜0.01); Total symptom integral, sign integration obviously reduce, and compare with matched group, and difference has highly significant property (P＜001).

Table 4: test front and back symptom, sign integration situation relatively for two groups

* compare P＜0.01 with matched group test back; With comparison △ P＜0.01 before the test-meal of this group.

5.3.2 two groups of test back 15 routine gastroscope results relatively

Table 5: two groups of test back 15 routine gastroscope results relatively

Can find out from table 5: each 15 example of test-meal group and matched group, test back gastroscopy is compared, and test-meal group gastroscope improvement situation is superior to matched group (P＜0.05).

6, test brief summary

Through statistics, self relatively reach test back test-meal group and matched group before and after the test of test-meal group relatively, clinical symptoms, sign integration obviously reduce, and difference has significance (P＜0.01); Two groups of each the 15 routine gastroscope checks in test back, test-meal group gastroscope improvement situation is superior to matched group (P＜0.05).Experimenter blood before and after the test, urine, just routine and liver, renal function each item detect index all in normal range; No abnormality seens such as spirit, sleep, defecation before and after the test-meal of test-meal group; And health is had no adverse effects.According to the criterion of " health food check and assessment technique standard ", think that yellow Pu Indian buead capsule has assistant protection function to gastric mucosa injury.

Embodiment 6: yellow Pu Indian buead capsule

1, forms (weight: g): 65 parts of the Radixs Astragali, 37 parts in Poria, 15 parts of Herba Taraxacis, 9 parts of Fructus Evodiaes, 7 parts of the Radixs Angelicae Dahuricae, 2 parts of Concha Ostreae (calcined)s.

2, method for preparing:

2) then medicine is crushed to 60 orders, adds the dextrin of finished product preparation 9.1%, 0.44% magnesium stearate, mix homogeneously, encapsulated.

3) usage and dosage: every day 2 times, each 4.

Embodiment 7: yellow Pu Indian buead capsule

1, forms (weight: kg): 45 parts of the Radixs Astragali, 29 parts in Poria, 12 parts of Herba Taraxacis, 7 parts of Fructus Evodiaes, 6 parts of the Radixs Angelicae Dahuricae, 2 parts of Concha Ostreae (calcined)s.

2, method for preparing:

2) Radix Astragali, Poria, Herba Taraxaci, Fructus Evodiae decocte with water are 2 times, add 10 times of water gagings at every turn, decoct 2 hours.75 ℃-0.065Mpa is evaporated to the clear paste that relative density is 1.30～1.35 (60 ℃ of surveys);

5) mix A, B powder, add the dextrin of finished product preparation 9.1%, 0.44% magnesium stearate, mix homogeneously, encapsulated.

6) usage and dosage: every day 2 times, each 4.

Embodiment 8: yellow Pu Indian buead capsule

1, forms (weight: g): 37 parts of the Radixs Astragali, 40 parts in Poria, 25 parts of Herba Taraxacis, 14 parts of Fructus Evodiaes, 20 parts of the Radixs Angelicae Dahuricae, 6 parts of Concha Ostreae (calcined)s.

2, method for preparing:

2) Radix Astragali, Poria, Herba Taraxaci, Fructus Evodiae decocte with water are 2 times, add 10 times of water gagings at every turn, decoct 2 hours, and 75 ℃-0.065Mpa is evaporated to the clear paste that relative density is 1.30～1.35 (60 ℃ of surveys);

6) usage and dosage: every day 2 times, each 4.

Embodiment 9: yellow Pu Indian buead capsule

1, forms (weight: g): 52 parts of the Radixs Astragali, 38 parts in Poria, 26 parts of Herba Taraxacis, 5 parts of Fructus Evodiaes, 3 parts of the Radixs Angelicae Dahuricae, 2.6 parts of Concha Ostreae (calcined)s.

2, method for preparing:

6) usage and dosage: every day 2 times, each 4.

Though, used general explanation, the specific embodiment and test in the preceding text, the present invention has been done detailed description, on basis of the present invention, can to some modifications of do or improvement, this will be apparent to those skilled in the art.Therefore, these modifications or improvements all belong to the scope of protection of present invention without departing from theon the basis of the spirit of the present invention.

Claims

1. a Chinese medicine composition of preventing and treating the gastric mucosa damage is characterized in that the active component of this Chinese medicine composition is processed by following parts by weight of Chinese traditional medicine: Radix Astragali 35-58 part; Poria 20-26 part, Herba Taraxaci 9-24 part, Fructus Evodiae 5-12 part; Radix Angelicae Dahuricae 5-12 part, Concha Ostreae (calcined) 3-6 part.

2. Chinese medicine composition according to claim 1 is characterized in that, the active component of this Chinese medicine composition is processed by following parts by weight of Chinese traditional medicine: 50 parts of the Radixs Astragali, 22 parts in Poria, 17 parts of Herba Taraxacis, 10 parts of Fructus Evodiaes, 10 parts of the Radixs Angelicae Dahuricae, 5 parts of Concha Ostreae (calcined)s.

3. claim 1 or 2 said Chinese medicine compositions is characterized in that, the adjuvant of this Chinese medicine composition is pharmaceutically acceptable carrier or diluent.

4. Chinese medicine composition according to claim 3 is characterized in that, said Chinese medicine composition is tablet, pill, capsule or granule.

5. a method for preparing the described Chinese medicine composition of claim 3 is characterized in that, this method may further comprise the steps:

1) with the Radix Astragali, Poria, Herba Taraxaci, Fructus Evodiae, the Radix Angelicae Dahuricae, Concha Ostreae (calcined) screen respectively, pick, put in order;

3) with step 2) dry extract that obtains pulverizes and sieves, and the Radix Angelicae Dahuricae, Concha Ostreae (calcined) mix homogeneously with pulverizing add pharmaceutically acceptable carrier or diluent, according to the equivalent method mix homogeneously that progressively increases, are prepared into various dosage forms.

6. method according to claim 5 is characterized in that, this method may further comprise the steps:

2) Radix Astragali, Poria, Herba Taraxaci, Fructus Evodiae are extracted:

7. a method for preparing the described Chinese medicine composition of claim 3 is characterized in that, this method may further comprise the steps:

8. the application of each described Chinese medicine composition of claim 1-4 in the medicine of preparation prevention and treatment gastric mucosa injury.