CN1981860A - Chinese-medicinal composition for treating chronic gastritis and atrophic gastritis and its production - Google Patents

Abstract

A Chinese medicine in the form of particles for treating chronic gastritis and chronic atrophic gastritis and preventing stomach cancer is prepared from 10 Chinese-medicinal materials including notoginseng, white peony root, dandelion herb, liquorice root, etc. Its preparing process is also disclosed.

Description

The Chinese medicine composition and the preparation method of treatment chronic gastritis, chronic atrophic gastritis

Technical field

The present invention relates to a kind of pharmaceutical composition, relating in particular to a kind of is the Chinese medicine composition of the treatment chronic gastritis that forms of feedstock production and the canceration in early stage of prevention stomach with the Chinese herbal medicine, and the preparation method of this Chinese medicine composition, belongs to the field of Chinese medicines.

Background technology

In digestive system disease, chronic atrophic gastritis is comparatively common disease, account for the clinical patient's of being examined 13%, and sickness rate raises along with the increase at age.Gastric epithelial makes after the infringement of suffering repeatedly and the intrinsic body of gland atrophy or the disappearance of mucosa produces pathological changes.The normal companion of serious atrophic gastritis sees that intestinal epithelial metaplasia or atypical hyperplasia are arranged, might develop into gastric cancer, gastric mucosa atrophy--intestinal epithelial metaplasia--atypical hyperplasia--gastric cancer, be considered to a kind of progressive process that gastric cancer takes place, so people are called a kind of of disease before the gastric cancer cancer with atrophic gastritis in recent years.Gastric cancer is one of common malignancy the most, and China has 15～160,000 people to die from gastric cancer every year approximately, and M ﹠ M occupy first of the various malignant tumor.Because the cause of disease to gastric cancer is also clear fully, old friends implement at the primary prevention of the gastric cancer cause of disease very difficult.Prevent and treat gastric mucosa early and transform, become people's research emphasis in recent years to the canceration direction.Gastric mucosa atrophy is the important stage of gastric mucosal lesion, and the intestinal epithelial metaplasia or the atypical hyperplasia for the treatment of the atrophy of gastric mucosa early and producing on this basis are the important contents of present digestive system disease clinical therapeutics.

Chronic atrophic gastritis clinical mainly shows as gastral cavilty feeling of fullness, stifled vexed discomfort, food postemphasis, or doublely sees characteristics such as distending pain, analyzes by motherland's theory of medicine, belongs to the category of feeling of fullness, stomachache.

The disease of feeling of fullness comes across " interior warp " the earliest, claims "No", " expiring ", " not plug ", " not diaphragm ".As " element is asked. the treatment in accordance with local conditions opinion " and cloud: " cold in ZANG-organs leading to distention with fullness "; The most pure virginity will be discussed greatly " cloud: " answering of the sun, the gas of fainting is up,--, heart stomach is given birth to cold, and chest and diaphragm is unfavorable, and is pained not full ", these are meant that all the chest and diaphragm painful abdominal mass is vexed, the notion of epigastric oppression plug.Eastern Han Dynasty's Zhang Zhongjing clearly proposes: " this is painful abdominal mass for the feeling fullness but no pain person ", to its origin cause of formation, Zhong Jing thinks the main typhoid sun stage, and the doctor is purgation early, and a positive exogenous pathogen ancient attendants in charge of cart and horses for aristocrats is due to the lifting imbalance.Sui. Chao Yuanfang (550-630 A.D.) " General Treatise on the Cause and Symptoms of Diseases. all painful abdominal masss is waited " name of " eight painful abdominal masss ", " all painful abdominal masss " is proposed, the non-only end of the reason that causes painful abdominal mass be described, general its pathogenesis, but nothing more than disharmony of nutrient QI with defensive QI, negative and positive completely cut off, vim and vigour are jammed, must not declare logical.Song. and Zhu Danxi " danxi's experiential therapy. painful abdominal mass " cloud: " whether same, also not refreshed painful abdominal mass person is ".Gold dollar Lee Dong Yuan advocates saying of taste greatly, proposes the viewpoint of " disorder of the spleen and stomach caused by internal damage, all kinds of diseases and ailments are by life ", points out that the trouble of feeling of fullness and weakness of the spleen and stomach have substantial connection.More detailed, bright to the Ming and Qing times to the understanding of feeling of fullness. and Wang Kentang " Standards of Diagnosis and Treatment. painful abdominal mass " on the forefathers basis, painful abdominal mass differentiates that with bloated think and expand in abdomen that its disease is tangible, painful abdominal mass is under the heart, its disease is invisible." Jing Yue's complete work. feeling of fullness " dialectical rather distinct to primary disease, " painful abdominal mass person, the meaning that the painful abdominal mass plug is not opened also, full person, the meaning that distension is not all right also.Lid is full then closely bloated, and painful abdominal mass then needn't expand also.So epigastric fullness has greatly to doubt and distinguishes, then at deficiency and excess two words, all have heresy to have to stagnate and painful abdominal mass person, stuffiness syndrome of excess type also, naivete does not have and stagnates and painful abdominal mass person, stuffy sensation of deftciency type also.Have bloated, pain is arranged and full person, real fullly yet do not have and expand painless and full person, fullness sensation due to deficiency also.Stuffiness syndrome of excess type real completely person can loose and can disappear, stuffy sensation of deftciency type fullness sensation due to deficiency person, temperature compensation greatly ".Li Zhongzi's cloud: " have too far damp and hot,--be painful abdominal mass person, divide disappear about, rule together with wet ", Lin Peiqin cloud: " rage impairing the liver, QI rising in reverse order and painful abdominal mass " etc.Aspect the Therapeutic Principle, Zhong Jing initiates on the basis of determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs, serves as treatment feeling of fullness all cards with five XIEXIN TANG, and is dialectical clear and definite, cube precise and appropriate, taken over for back physicians from a family for generations family always.Lin Peiqin " Lei Zheng Zhi Cai. feeling of fullness " in opinion is controlled outstanding detailed, " painful abdominal mass of typhoid fever (calentura) is within outer; so should hardship let out; the painful abdominal mass of miscellaneous diseases, outside interior, so should suffering diffusing " proposed, and with the feeling of fullness of miscellaneous diseases be divided into that the cold retention of phlegm that stagnates of appetite, diet cold and coolly injure one's stomach, taste weakened YANG QI, chronic deficiency of QI of middle-JIAO, precise and tinyly do not change, some pattern of syndrome such as insufficiency of the spleen mistake fortune, the insufficiency of stomach stagnation of QI, point out that it also has cold and heat and asthenia and sthenia other, should classify and control it, make a careful and detailed analysis, because of card choosing side, directive significance arranged to clinical.

Take a broad view of the argumentation of ancient Chinese medicine doctor to feeling of fullness, as can be seen: the paathogenic factor of feeling of fullness mainly comprises: eating and drinking without temperance, lead an irregular life, cold damaging the spleen and stomach, invasion of pathogenic factor from the exterior into the interior, invade in damp and hot, feelings will discord, mental disorder are fought knot and weakness of the spleen and stomach for suffering from, sick position is many at taste, and relates to liver; The treatment aspect emphasizes that void then should be mended, stuffiness syndrome of excess type is worked as the side's of controlling principle of rushing down.

Yet, at present, many based on relief of symptoms for the western medical treatment of chronic atrophic gastritis about the present Research of the clinical therapeutics of chronic atrophic gastritis and unsatisfactory, there is no the improvement effect for the gastric mucosa that atrophy takes place, only we can say and take stopgap measures, do not effect a permanent cure.The Chinese patent medicine that has been used for the treatment of chronic atrophic gastritis clinically has a large amount in variety; such as: (its primary raw material has SANJIU WEITAI KELI: Foliumet Ramulus Evodiae; Folium Et Cacumen Murrayae; Radix Zanthoxyli; the Radix Aucklandiae; Radix Scutellariae; Poria; Radix Rehmanniae; the Radix Paeoniae Alba); (its prescription mainly contains following medical material to the WENWEISHU granule: Radix Codonopsis; Radix Astragali Preparata; Radix Aconiti Lateralis Preparata (system); Cortex Cinnamomi; Fructus Psoraleae; Herba Cistanches (system); the Rhizoma Atractylodis Macrocephalae (stir-fry); Rhizoma Dioscoreae; Fructus Crataegi (stir-fry); Fructus Mume; Fructus Amomi; Pericarpium Citri Reticulatae); the YANGWEISHU granule; (its prescription mainly contains following medical material: Radix Codonopsis; the Rhizoma Atractylodis Macrocephalae (stir-fry); Rhizoma Polygonati (steaming); Rhizoma Dioscoreae; Radix Glehniae; Fructus Mume; Radix Scrophulariae; Semen Cuscutae; Rhizoma Zingiberis; Pericarpium Citri Reticulatae; Fructus Crataegi (parched)); (its prescription mainly contains following medical material to MOLUO DAN: Bulbus Lilii; Radix Ophiopogonis; Herba Dendrobii; Poria; the Rhizoma Atractylodis Macrocephalae (parched with bran); the Radix Linderae; the Radix Paeoniae Alba; Radix Notoginseng; Rhizoma Corydalis (processed with vinegar); Endothelium Corneum Gigeriae Galli (frying fragrant); Radix Scrophulariae; Radix Angelicae Sinensis); (its prescription mainly contains following medical material to WEINAI AN JIAONANG: the Radix Astragali; Radix Notoginseng; Radix Ginseng Rubra; Margarita layer powder; the artificial Calculus Bovis); (its prescription mainly contains following medical material to WEIFUCHUN PIAN: Radix Ginseng; Herba Rabdosiae glaucocalycis; Fructus Aurantii (parched); positive stomach sheet, its prescription mainly contains following medical material: Ramulus Et Folium Pithecellobii Lucidi; Pericarpium Citri Reticulatae; Radix Schefflerae Arboricolae (Caulis et Folium Schefflerae Arboricolae); the Radix Aucklandiae; Radix Glycyrrhizae; aluminium hydroxide; magnesium oxide; bismuth subnitrate); (its prescription mainly contains following medical material to stomach nourishing granule: the Radix Astragali; Radix Codonopsis; Pericarpium Citri Reticulatae; Rhizoma Cyperi; the Radix Paeoniae Alba; Rhizoma Dioscoreae; Fructus Mume; Radix Glycyrrhizae); (its prescription mainly contains following medical material to the WEILEXIN granule: Hericium erinaceus (Bull. Ex Fr.) Pers.); (its prescription mainly contains following medical material to compound recipe Radix Notoginseng capsule for treating stomachache: Radix Notoginseng; Rhizoma Corydalis; Rhizoma Cyperi; Fructus Evodiae; Fructus Toosendan; the Radix Paeoniae Alba; Pseudobulbus Bletillae (Rhizoma Bletillae); dried Alumen; magnesium oxide; sodium bicarbonate etc.); having a stomachache, (its prescription mainly contains following medical material to peaceful sheet: Herba Taraxaci; Radix Gentianae; Radix Glycyrrhizae dry extractum; fennel oil; Semen Hyoscyami extractum; aluminium hydroxide); (its prescription mainly contains following medical material to the Veytalo oral liquid for relaxation: the Hericium erinaceus (Bull. Ex Fr.) Pers. concentrated solution; Lac regis apis).Above-mentioned these Chinese patent medicines all have certain curative effect for chronic atrophic gastritis, but also all in various degree exist uncertain therapeutic efficacy cut, can not treating both the principal and secondary aspects of a disease etc. defective, be needing to demand the problem that solves at present urgently so develop the Chinese medicine composition of the treatment chronic atrophic gastritis of a kind of determined curative effect, treating both the principal and secondary aspects of a disease.

Summary of the invention

The present invention's technical problem at first to be solved is to overcome the deficiencies in the prior art, treatment chronic gastritis, the chronic atrophic gastritis of a kind of determined curative effect, treating both the principal and secondary aspects of a disease is provided and has the Chinese medicine composition that prevents stomach canceration in early stage.

The present invention's technical problem at first to be solved realizes by following technological approaches:

A kind of Chinese medicine composition for the treatment of chronic gastritis, chronic atrophic gastritis and having the canceration effect in early stage of prevention stomach, make by following bulk drugs:

Radix Pseudostellariae 90-110 part, Herba Dendrobii 40-60 part, Radix Notoginseng 4-6 part, Rhizoma Curcumae 30-50 part, Radix Curcumae 30-50 part, Radix Paeoniae Alba 30-50 part, Herba Hedyotidis Diffusae 56.67-76.67 part, Herba Taraxaci 73.33-93.33 part, Herba Scutellariae Barbatae 40-60 part, Radix Glycyrrhizae 10-30 part.

Preferably, the weight portion of each crude drug is: 100 parts of Radix Pseudostellariaes, 50 parts of Herba Dendrobiis, 5 parts of Radix Notoginseng, 40 parts of Rhizoma Curcumae, 40 parts of Radix Curcumaes, 40 parts of the Radix Paeoniae Albas, 66.67 parts of Herba Hedyotidis Diffusaes, 83.33 parts of Herba Taraxacis, 50 parts of Herba Scutellariae Barbataes, 20 parts in Radix Glycyrrhizae.

The inventor passes through clinical research for many years, in conjunction with modern achievement in research, the main pathological characteristic that sums up chronic atrophic gastritis is that weakened body resistance (mainly being deficiency of both QI and YIN) stagnant heat is for suffering from, on this basis, in conjunction with the dialectical principle that combines with differential diagnosis of diseases, summary is the pharmaceutical composition of the present invention of the main rule of treatment with supplementing QI and nourishing YIN, regulating the flow of QI to dissipate blood stasis, heat clearing away eliminating stagnation, tries out in clinical, obtains comparatively ideal therapeutic effect for chronic atrophic gastritis.

Chronic atrophic gastritis is that gastric epithelial makes the intrinsic body of gland atrophy or the disappearance of mucosa after the infringement of suffering repeatedly, produces pathological changes.The normal companion of serious atrophic gastritis sees that intestinal epithelial metaplasia or atypical hyperplasia are arranged.The chronic atrophic gastritis main clinical manifestation is: gastral cavilty feeling of fullness, stifled vexed discomfort, food postemphasis or doublely see that distending pain etc. is arranged, the category that should belong to diseases such as " stomach painful abdominal mass ", " gastric abscess " by motherland's theory of medicine differential diagnosis of diseases, its sick position is at taste, with the liver associated, weakened body resistance (mainly being deficiency of both QI and YIN) stagnant heat is its main pathologic basis.Taste occupy Central Region, and The spleen is in charge of sending up essential substances, the stomach being liable to sending digested food downward, and the taste lifting is suitable, and then the ascending or descending movement of vital Qi operation is normal, and internal organs meridians extremity bones of the body collectively gets it and supplements nutrition and normal operation.The taste rising-falling tone and, normally be prerequisite with liver controlling conveyance and dispersion, catharsis degree of having, then rising-falling tone and.If invasion of pathogenic factor from the exterior into the interior, seven emotions are become estranged, eating and drinking without temperance, turbid damp internal resistance, mental disorder are fought knot, weakness of the spleen and stomach, cause the taste abnormal ascending-descending of QI, the card that often causes feeling of fullness takes place, so " element is asked. the hexa-atomic big piece of writing of discussing of just recording " and cloud: " lunar is extremely, for long-pending drink is denied a diaphragm ", " card is controlled and converge to be mended. feeling of fullness " cloud: " and painful abdominal mass is held by the moon volt sun; QI and blood is not transported and formed, and is under the heart, is positioned at central authorities; fill up the painful abdominal mass plug, all wet soil be disease also ".Taste deficiency of qi and yin, the deficiency of vital energy then spleen fortune lose strongly, and the cloudy stomach that loses then loses and moistens, and taste lifting painful abdominal mass plug and be the disease of the stifled vexed discomfort of feeling of fullness must eat that then more to cause strong fortune not normal, so the food postemphasis.Pathological changes with the passing of time, disease must be gone into network and be formed the stagnant trouble of the stasis of blood.Positive exogenous pathogen poison is easily invaded, and with the passing of time the stasis of blood stagnates, and gives birth in the evil poison, and pathogenic heat more cause the taste lifting and are obstructed, and increases the weight of the stifled vexed uncomfortable card of feeling of fullness.

Pharmaceutical composition of the present invention is the rule of treatment with supplementing QI and nourishing YIN, regulating the flow of QI to dissipate blood stasis, heat clearing away eliminating stagnation, select compositions such as Radix Pseudostellariae, Herba Dendrobii, Radix Notoginseng, Rhizoma Curcumae, Radix Curcumae, the Radix Paeoniae Alba, Herba Hedyotidis Diffusae, Herba Taraxaci, Herba Scutellariae Barbatae, Radix Glycyrrhizae for use, Radix Pseudostellariae, Herba Dendrobii yin nourishing stomach reinforcing are thought monarch in the side, the void of reason taste, target is to effect a permanent cure; Join Radix Notoginseng, Rhizoma Curcumae, Radix Curcumae, Radix Paeoniae Alba regulating the flow of QI to dissipate blood stasis and think minister, the stasis of blood stagnates to such an extent that go, and then lifting can be answered; Herba Hedyotidis Diffusae, Herba Taraxaci, the peaceful stomach of Herba Scutellariae Barbatae heat clearing away removing toxic substances are thought assistant, treating both the principal and the secondary aspects of a disease at the same time; The Radix Glycyrrhizae coordinating the actions of various ingredients in a prescription.In the side all medicines mutually and, play the effect of supplementing QI and nourishing YIN, regulating the flow of QI to dissipate blood stasis, heat clearing away eliminating stagnation altogether.

The used crude drug of the present invention all can be bought from common pharmacy and obtain, and its specification meets national medical standard.

Medicine activity component of the present invention can add various adjuvants required when preparing different dosage form, for example disintegrating agent, lubricant, adhesive etc., method of Chinese medicinal with routine is prepared into any oral formulations commonly used, can be pill, capsule, tablet, powder, granule or oral liquid etc. for example, be preferably granule.

Preferably, a kind of preparation of drug combination method of the present invention may further comprise the steps:

(1) takes by weighing each raw material by following weight portion: Radix Pseudostellariae 90-110 part, Herba Dendrobii 40-60 part, Radix Notoginseng 4-6 part, Rhizoma Curcumae 30-50 part, Radix Curcumae 30-50 part, Radix Paeoniae Alba 30-50 part, Herba Hedyotidis Diffusae 56.67-76.67 part, Herba Taraxaci 73.33-93.33 part, Herba Scutellariae Barbatae 40-60 part, Radix Glycyrrhizae 10-30 part;

(2) get Rhizoma Curcumae, Radix Curcumae and extract volatile oil after, medicinal residues decoct with water, decoction liquor is centrifugal, gets supernatant, extracting solution A;

(3) get Radix Pseudostellariae, Herba Dendrobii, the Radix Paeoniae Alba, Herba Hedyotidis Diffusae, Herba Taraxaci, Herba Scutellariae Barbatae, Radix Glycyrrhizae and decoct with water, collecting decoction, filtration, extracting solution B;

(4) Radix Notoginseng is used alcohol reflux, extracting solution filters, and reclaims ethanol, gets extracting solution C;

(5) merge said extracted liquid A, B, C, concentrating under reduced pressure, centrifugal, get supernatant, get extracting solution D;

(6) get Rhizoma Curcumae, Radix Curcumae volatile oil, add among the extracting solution D, get the pharmaceutical preparation intermediate, make finished product through preparations shaping technology again; Perhaps the dry extract that makes after drying of extracting solution D is made the preparation intermediate again, adds Rhizoma Curcumae, Radix Curcumae volatile oil, mixing, and drying is made finished product through preparations shaping technology.

In the above-mentioned preparation method, wherein preferably the medicinal residues of Rhizoma Curcumae and Radix Curcumae are added 8～15 times of weight decoctings in the step (2) and boiled 1～3 hour; Step preferably decocts with water twice with Radix Pseudostellariae, Herba Dendrobii, the Radix Paeoniae Alba, Herba Hedyotidis Diffusae, Herba Taraxaci, Herba Scutellariae Barbatae, Radix Glycyrrhizae in (3), adds 8～15 times of weight decoctings for the first time and boils 1～3 hour, adds 8～15 times of weight decoctings 1～3 hour for the second time; In the step (4) preferably with Radix Notoginseng with 50%～90% alcohol reflux 3 times; For the first time 4～8 times of weight 50%～90% ethanol extractions are 1～3 hour, and 4～8 times of weight 50%～90% ethanol extractions are 1～3 hour for the second time, and 4～8 times of weight 50%～90% ethanol extractions are 1～3 hour for the third time.

Usage and consumption: the dosage of medicine of the present invention depends on concrete dosage form, and factor such as age of patient, body weight, health status.As guidance: granule, each oral 7g that is grown up, every day 3 times, three months is a course of treatment, treats 1-3 the course of treatment.

The specific embodiment

Further describe the present invention by the following examples, it should be understood that these embodiment only are used for the purpose of illustration, never limit protection scope of the present invention.

The preparation of [embodiment 1] granule

Take by weighing each raw material by following weight: Radix Pseudostellariae 10000g, Herba Dendrobii 5000g, Radix Notoginseng 500g, Rhizoma Curcumae 4000g, Radix Curcumae 4000g, Radix Paeoniae Alba 4000g, Herba Hedyotidis Diffusae 6667g, Herba Taraxaci 8333g, Herba Scutellariae Barbatae 5000g, Radix Glycyrrhizae 2000g;

Above-mentioned ten flavor medical materials are handled through clean, clean system; After getting Rhizoma Curcumae, Radix Curcumae and extracting volatile oil with the water vapour extracting method, medicinal residues add 8 times of weight decoctings and boiled 1.5 hours, merge decoction liquor, and are centrifugal, extracting solution A; Get Radix Pseudostellariae, Herba Dendrobii, the Radix Paeoniae Alba, Herba Hedyotidis Diffusae, Herba Taraxaci, Herba Scutellariae Barbatae, Radix Glycyrrhizae and decoct with water twice, add 10 times of weight decoctings for the first time and boiled 2 hours, add 8 times of weight decoctings 1.5 hours for the second time, collecting decoction filters, extracting solution B; After getting Radix Notoginseng powder and being broken into coarse grain, with 70% alcohol reflux three times, 6 times of weight were extracted 2 hours for the first time, and 5 times of weight were extracted 1.5 hours for the second time, and 4 times of weight were extracted 1 hour for the third time, merged, and filtered, and reclaimed ethanol, extracting solution C; Merge said extracted liquid A, B, C, be evaporated to relative density 1.05～1.10 (60 ℃), centrifugal, get extracting solution D; Get extracting solution D, drying gets extract powder.Get extract powder, transfer to 7000 grams with lactose, mix thoroughly, dry-pressing becomes granule, adds Rhizoma Curcumae, Radix Curcumae volatile oil, mixing, and granulate, packing, promptly.

The preparation of [embodiment 2] capsule

Take by weighing each raw material by following weight: Radix Pseudostellariae 9000g, Herba Dendrobii 4000g, Radix Notoginseng 400g, Rhizoma Curcumae 3000g, Radix Curcumae 3000g, Radix Paeoniae Alba 3000g, Herba Hedyotidis Diffusae 5667g, Herba Taraxaci 7333g, Herba Scutellariae Barbatae 4000g, Radix Glycyrrhizae 1000g;

Above-mentioned ten flavor medical materials are through cleaning, making only and handle; After getting Rhizoma Curcumae, Radix Curcumae and extracting volatile oil with the vapor extraction method, medicinal residues decoct with water, and decoction liquor is centrifugal, extracting solution A; Get Radix Pseudostellariae, Herba Dendrobii, the Radix Paeoniae Alba, Herba Hedyotidis Diffusae, Herba Taraxaci, Herba Scutellariae Barbatae, Radix Glycyrrhizae and decoct with water, collecting decoction filters, extracting solution B; After getting Radix Notoginseng powder and being broken into coarse grain,, merge, filter, reclaim ethanol with alcohol reflux three times, extracting solution C; Merge said extracted liquid A, B, C, concentrating under reduced pressure relative density 1.05～1.10 (60 ℃), centrifugal, get extracting solution D; Get extracting solution D, drying gets extract powder.Get extract powder, add adjuvant (as starch) and transfer to 5000 grams in right amount, mix thoroughly, dry-pressing becomes granule, and granulate adds Rhizoma Curcumae, Radix Curcumae volatile oil, and mixing is encapsulated, packing, promptly.

The preparation of [embodiment 3] tablet

Take by weighing each raw material by following weight: Radix Pseudostellariae 11000g, Herba Dendrobii 6000g, Radix Notoginseng 600g, Rhizoma Curcumae 5000g, Radix Curcumae 5000g, Radix Paeoniae Alba 5000g, Herba Hedyotidis Diffusae 7667g, Herba Taraxaci 9333g, Herba Scutellariae Barbatae 6000g, Radix Glycyrrhizae 3000g;

Above-mentioned ten flavor medical materials are through cleaning, making only and handle; After getting Rhizoma Curcumae, Radix Curcumae and extracting volatile oil with the vapor extraction method, medicinal residues add 15 times of weight decoctings and boiled 3 hours, merge decoction liquor, and are centrifugal, extracting solution A; Get Radix Pseudostellariae, Herba Dendrobii, the Radix Paeoniae Alba, Herba Hedyotidis Diffusae, Herba Taraxaci, Herba Scutellariae Barbatae, Radix Glycyrrhizae and decoct with water twice, add 15 times of weight decoctings for the first time and boiled 3 hours, add 15 times of weight decoctings 3 hours for the second time, collecting decoction filters, extracting solution B; After getting Radix Notoginseng powder and being broken into coarse grain, with 90% alcohol reflux three times, 8 times of weight were extracted 3 hours for the first time, and 8 times of weight were extracted 3 hours for the second time, and 8 times of weight were extracted 3 hours for the third time, merged, and filtered, and reclaimed ethanol, extracting solution C; Merge said extracted liquid A, B, C, be evaporated to relative density 1.05～1.10 (60 ℃), centrifugal, get extracting solution D; Get extracting solution D, drying gets extract powder.Get extract powder, transfer to 10000 grams in right amount with adjuvant (as starch, dextrin or low-substituted hydroxypropyl cellulose), mix thoroughly, dry-pressing becomes granule, and granulate adds Rhizoma Curcumae, Radix Curcumae volatile oil, adds right amount of auxiliary materials, mixing, and tabletting, packing, promptly.

The preparation of [embodiment 4] pill

Take by weighing each raw material by following weight: Radix Pseudostellariae 10500g, Herba Dendrobii 4500g, Radix Notoginseng 450g, Rhizoma Curcumae 4500g, Radix Curcumae 4500g, Radix Paeoniae Alba 3500g, Herba Hedyotidis Diffusae 6617g, Herba Taraxaci 8000g, Herba Scutellariae Barbatae 5500g, Radix Glycyrrhizae 2500g;

Above-mentioned ten flavor medical materials are through cleaning, making only and handle; After getting Rhizoma Curcumae, Radix Curcumae and extracting volatile oil with the vapor extraction method, medicinal residues add 8 times of weight decoctings and boiled 1 hour, merge decoction liquor, and are centrifugal, extracting solution A; Get Radix Pseudostellariae, Herba Dendrobii, the Radix Paeoniae Alba, Herba Hedyotidis Diffusae, Herba Taraxaci, Herba Scutellariae Barbatae, Radix Glycyrrhizae and decoct with water twice, add 8 times of weight decoctings for the first time and boiled 1 hour, add 8 times of weight decoctings 1 hour for the second time, collecting decoction filters, extracting solution B; After getting Radix Notoginseng powder and being broken into coarse grain, with 50% alcohol reflux three times, 4 times of weight were extracted 1 hour for the first time, and 4 times of weight were extracted 1 hour for the second time, and 4 times of weight were extracted 1 hour for the third time, merged, and filtered, and reclaimed ethanol, extracting solution C; Merge said extracted liquid A, B, C, be evaporated to relative density 1.05～1.10 (60 ℃), centrifugal, get extracting solution D; Get extracting solution D, drying gets extract powder, is crushed and screened into fine powder E.

General ball: make binding agent with ethanol, water or refined honey.A small amount of fine powder E is put into cylinder, start the pill cylinder, spray adds binding agent in a small amount, constantly be stirred to and make fine powder be moistening graininess, add an amount of fine powder E again, stirring evenly overlays on the granule it, and spray adds binding agent successively again, make powder slowly add the tiny pill of great achievement with the method, cross the sieve in 1mm aperture, the piller of getting the 1mm aperture sieve places the pill cylinder, continues to spray to add binding agent and spread to add fine powder E, cross the sieve in 2mm-2.5mm aperture, get the piller that sieves and make the ball kind; Add the ball kind in addition in the pill cylinder, start the pill cylinder, spray adds suitable amount of adhesive, adds an amount of fine powder again after stirring makes the piller moistening, becomes the piller that diameter is 3.0mm～3.5mm size with the general ball of the method to it, sieves; Get the piller that sieves again and drop in the pill cylinder, start pellet processing machine, more successively constantly spray add an amount of binding agent and spread and add fine powder, pill is strengthened gradually, be 4.5mm～5.0mm size to the piller diameter till.Take out, sieve, the wet ball of getting ball footpath 4.5-5.0mm range size carries out drying;

Dry: the ball stand dish that will wet, drying gets the ball embryo;

Coating: place the pill cylinder to roll every cylinder ball embryo, and spray into Rhizoma Curcumae, Radix Curcumae volatile oil, stir evenly, take out, get coated pill with Sprayable.

The preparation of [embodiment 5] powder

Take by weighing each raw material by following weight: Radix Pseudostellariae 10000g, Herba Dendrobii 5000g, Radix Notoginseng 500g, Rhizoma Curcumae 4000g, Radix Curcumae 4000g, Radix Paeoniae Alba 4000g, Herba Hedyotidis Diffusae 6667g, Herba Taraxaci 8333g, Herba Scutellariae Barbatae 5000g, Radix Glycyrrhizae 2000g;

Above-mentioned ten flavor medical materials are through cleaning, making only and handle; After getting Rhizoma Curcumae, Radix Curcumae and extracting volatile oil with the vapor extraction method, medicinal residues add 12 times of times of weight decoctings and boiled 1.5 hours, merge decoction liquor, and are centrifugal, extracting solution A; Get Radix Pseudostellariae, Herba Dendrobii, the Radix Paeoniae Alba, Herba Hedyotidis Diffusae, Herba Taraxaci, Herba Scutellariae Barbatae, Radix Glycyrrhizae and decoct with water twice, add 14 times of weight decoctings for the first time and boiled 2 hours, add 12 times of weight decoctings 1.5 hours for the second time, collecting decoction filters, extracting solution B; After getting Radix Notoginseng powder and being broken into coarse grain, with 70% alcohol reflux three times, 8 times of weight were extracted 2 hours for the first time, and 8 times of weight were extracted 1.5 hours for the second time, and 6 times of weight were extracted 1 hour for the third time, merged, and filtered, and reclaimed ethanol, extracting solution C; Merge said extracted liquid A, B, C, be evaporated to relative density 1.05～1.10 (60 ℃), centrifugal, get extracting solution D; Get extracting solution D, drying gets extract powder, adds appropriate amount of auxiliary materials (as starch, lactose), adds volatile oil, mixing, and packing, promptly.

The preparation of [embodiment 6] oral liquid

Take by weighing each raw material by following weight: Radix Pseudostellariae 10000g, Herba Dendrobii 5000g, Radix Notoginseng 500g, Rhizoma Curcumae 4000g, Radix Curcumae 4000g, Radix Paeoniae Alba 4000g, Herba Hedyotidis Diffusae 6667g, Herba Taraxaci 8333g, Herba Scutellariae Barbatae 5000g, Radix Glycyrrhizae 2000g;

Above-mentioned ten flavor medical materials are through cleaning, making only and handle; After getting Rhizoma Curcumae, Radix Curcumae and extracting volatile oil with the vapor extraction method, medicinal residues add 8 times of water weight and decocted 1.5 hours, merge decoction liquor, and are centrifugal, extracting solution A; Get Radix Pseudostellariae, Herba Dendrobii, the Radix Paeoniae Alba, Herba Hedyotidis Diffusae, Herba Taraxaci, Herba Scutellariae Barbatae, Radix Glycyrrhizae and decoct with water twice, add 10 times of weight decoctings for the first time and boiled 2 hours, add 8 times of weight decoctings 1.5 hours for the second time, collecting decoction filters, extracting solution B; After getting Radix Notoginseng powder and being broken into coarse grain, with 70% alcohol reflux three times, 6 times of weight were extracted 2 hours for the first time, and 5 times of weight were extracted 1.5 hours for the second time, and 4 times of weight were extracted 1 hour for the third time, merged, and filtered, and reclaimed ethanol, extracting solution C; Merge said extracted liquid A, B, C, be evaporated to relative density 1.05～1.10 (60 ℃), centrifugal, get extracting solution D; Get Rhizoma Curcumae, Radix Curcumae volatile oil and an amount of cosolvent (as: polyoxyethylene sorbitan monoleate), add among the extracting solution D, get extracting solution E; Get extracting solution E, add correctives, fill is sealed, packing, promptly.

[test example 1] Chinese medicine composition of the present invention is observed the test of cure of chronic gastritis rat model

One, test material

(1) laboratory animal: the SD rat, body weight 200-215g, regular grade is provided by Department of Health of Guangdong Province medical experimental animal field, Guangdong Province's laboratory animal certification of fitness: 94022.

(2) trial drug: 1. for the reagent thing: the granule that the embodiment of the invention 1 is prepared.2. positive control medicine: stomach nourishing granule, the 15g/ bag, lot number: 940408, produce by Chinese Hangzhou second pharmaceutical factory of traditional Chinese medicine.All prepare during above drug study with distilled water.

(3) main agents: 1. deoxycholic acid sodium salt.The 10g/ bottle, lot number: 920420.serva company produces, the import packing of biological chemical reagent shop, Shanghai; 2.95%, ethanol analytical pure, lot number: 940420-2, Guangzhou Chemical Reagent Factory production.

(4) animal experiment technique condition: animal observation ward, regular grade, the zoopery condition detects the certificate of competency, probatio inspectionem pecuoarem word: No. 9435.

Two, test method

(1) animal model preparation: get 80 of rats, male and female half and half, under the same conditions by the male and female sub-cage rearing, 5 in every cage, routine feeding standard particle feedstuff.Wherein 20 as the normal control group, all the other animals carry out modeling, concrete grammar is to gavage rat every 10 days with 60% ethanol in first month, concrete dosage is that every rat once gavages 2ml 60% ethanol, during make beverage with 20mmol/L deoxycholic acid sodium solution (distilled water preparation) and arbitrarily drink by rat; Drink by rat with 30% ethanol and 10mmol/L deoxycholic acid sodium solution respectively in second and third month, by turns once every 7 days.Randomly draw the minority animal before modeling finishes and do histopathologic examination, after the affirmation modeling success, carry out the grouping experiment treatment in end modeling in the 90th day and observe.

(2) laboratory animal grouping and treatment: the modeling animal is divided into four groups at random: the blank group, for the large and small dosage treatment group of reagent thing, positive control medicine treatment group, and establish the normal control group simultaneously.

For of 5 times, the 10 times administrations of reagent thing by clinical consumption, suitable crude drug amount 12.3g/kg, 24.6g/kg; The positive control medicine is by 10 times of administrations of clinical consumption (3.75g/Kg); To be made into the administration concentration of 1.23g/ml and 2.46g/ml for the large and small dosage of reagent thing respectively; The positive control medicine is mixed with the administration concentration of 0.375g/ml; The treatment treated animal is all irritated the Weishang by the 1.0ml/100g body weight and is stated medicine, and the blank group is irritated isopyknic distilled water, and be administered once every day, and continuous 40 days, each animal routine feeding carried out relevant index after administration finishes and detects.

(3) observation index and method of testing

1. body weight change: duration of test, per two weeks weigh once, and off-test is each treated animal body weight change relatively.

2. gastric analysis: Drug therapy finishes, each treated animal fasting 24 hours (freely drinking water) is put to death animal with the cervical vertebra dislocation method, wins full stomach, flush away surface blood stains, blot with filter paper, cut gastral cavity open, with 5ml distilled water flushing gastral cavity along greater gastric curvature, and in above-mentioned washing liquid, embathe 3 times, the supernatant of gastric juice specimen is analyzed, used the titration measuring free acid, survey pepsin activity with wheat Te Shi method.

3. histopathology is observed: along lesser gastric curvature from glandular stomach to pylorus get one of holostrome coat of the stomach (3 * 10mm), use 10% formalin fixed, the routine paraffin wax section, HE dyes, and makes om observation.The inflammation degree is divided 4 grades (1-4 branches): " 1 " NIP; " 2 " have the inflammatory cell that is dispersed on a small quantity at stomach mazaedium or bottom; " 3 " all have more inflammatory cell at the gastric mucosa each several part; " 4 " have gathering cell infiltration in heaps in mucosa.Observe the holostrome gastric mucosa under low power lens, 10 visuals field are got in each section: comprise 4 in hole portion, 1 of hole body intersection, 4 of bodies, 1 of glandular stomach and glandular stomach intersection.By the inflammation classification in each visual field, press hole portion, hole body boundary, body, glandular stomach and four positions of glandular stomach intersection, get its average and compare.Measuring muscular layer of mucosa thickness with micrometer, is measurement unit with um, and 8 visuals field are got in each section, and each four of hole portion, bodies are obtained the average of hole portion, body respectively, reflect the connective tissue proliferation situation with this.

Three, experimental result

(1) influence that rat body weight is changed

The modeling rat is finished from the 2nd thoughtful modeling, and the normal matched group of its body weight gain descends, and animal appearance fur drying, lack gloss, the movable minimizing becomes thin, through Drug therapy, increase to some extent than the blank group for two dosage groups of reagent thing and the growth of positive control medicine treatment group rat body weight.

(2) to the influence of free acidity and pepsin activity in the gastric juice

1. the normal matched group of blank group rat stomach liquid Titrable acid descends, raise for the blank group of examination medication therapy groups, positive control medicine treatment group rat, but not statistically significant (seeing Table 1).

2. pepsin activity descends to some extent than normal group in the blank group rat gastric juice, but no difference of science of statistics supplies more also no difference of science of statistics (seeing Table 1) of reagent thing and positive control medicine treatment group and blank group.

The variation of table 1 chronic gastritis rat treatment back gastric juice Titrable acid pepsin activity

Group	Number of animals (only)	Gastric juice Titrable acid (mmol/l)	Pepsin activity (active unit/ml)
				Normal control group blank group is organized positive control medicine group for reagent thing small dose group for reagent thing heavy dose	10 15 13 13 13	10.46±3.08 9.04±2.84 10.03±2.18 10.52±2.22 10.6±2.5	62.3±10.4 52.5±19.4 50.8±12.5 56.2±11.3 54.0±11.8

(3) pathology of gastric mucosa histological observation

1. perusal: rats in normal control group gastric mucosa pinkiness, surfacing is smooth, and feel elasticity is better.The sticking more shallow or kermesinus of color of blank treated animal stomach, the surface lacks gloss, and there is tongue shape thing on the animal surface that has, erases with hands, and blood vessel is easily seen under the mucosa, and feel elasticity is relatively poor, and for examination medication therapy groups gastric mucosa of rat pale red or kermesinus, surperficial tongue shape thing is less.

2. om observation:

(1) stomach lining inflammation changes: the gastric epithelial of rats in normal control group is complete, the body of gland that dense arrangement is arranged in the lamina propria, as seen a small amount of lymphocyte that is dispersed in the lamina propria of glandular stomach and glandular stomach intersection, part gastric antrum portion, hole body interface, at the lymphocyte that as seen the mucosa bottom is dispersed on a small quantity, body of stomach does not have obvious cell infiltration.

The inflammation degree of blank group rat gastric antrum portion, body of stomach, glandular stomach and glandular stomach intersection and hole body interface is all more obvious, especially heavier with the inflammation degree of gastric antrum portion, glandular stomach and glandular stomach interface, lymphocyte and neutrophilic infiltration are arranged in the body of stomach lamina propria, little vasodilation hyperemia, the mucosal thickness attenuation, intrinsic gland parietal cell quantity slightly reduces, in the gastric antrum portion lamina propria of part animal more lymphocyte and neutrophilic infiltration are arranged, the position body of gland that has shortens or the body of gland spacing broadens.

Supply the inflammation degree of gastric antrum portion, body of stomach, hole body interface, glandular stomach and the glandular stomach interface of reagent thing and positive control medicine treatment treated animal all to alleviate, improve comparatively obviously (seeing Table 2) with gastric antrum portion, hole body interface than blank group.

The variation of table 2 chronic gastritis rat treatment back each inflammation of gastric mucosa

Group	Number of animals (only)	The inflammation degree (X ± SD)
						Hole portion	The hole body has a common boundary	Body	Glandular stomach and glandular stomach have a common boundary
		Normal control group blank group is organized positive control medicine group for reagent thing small dose group for reagent thing heavy dose	10 15 12 12 12	1.38±0.25 2.27±0.36 1.82±0.23** 1.94±0.07* 1.93±0.12*	1.75±0.50 2.01±.02 1.55±0.52** 1.5±0.51** 1.83±0.46					1.31±0.13 1.55±0.25## 1.31±0.11 1.41±0.19 1.50±0.18	1.38±0.47 2.13±0.35## 1.91±0.3 1.79±0.36* 1.82±0.28*

Compare with the normal control group: ##P＜0.01, compare with the blank group: * P＜0.05, * * P＜0.01.

(2) variation of gastric mucosa connective tissue: the muscular layer of mucosa of normal control treated animal body of stomach is thinner, and its thickness is 1/10 of mucosal thickness, and the place is thicker at the wrinkle wall.Hole portion mucous layer is then thicker, especially with near the pylorus place for very, the position that has can reach about 1/4 of mucosal thickness, muscular layer of mucosa is mainly the muscle fiber tissue, and a small amount of connective tissue is only arranged.

The muscular layer of mucosa of blank group obviously thickens, and more all to have the muscle fiber of the position muscular layer of mucosa that significant difference (P＜0.01.P＜0.001) has to arrange disorderly with normal group respectively for hole portion, body flesh layer thickness, and upwards hypertrophy is cut apart and held intrinsic body of gland.Muscular layer of mucosa thickness for the gastric antrum portion of reagent thing and positive control medicine treatment group or body of stomach is all thin than blank group, and the change of and positive control medicine treatment group heavy dose of for the reagent thing is remarkable (seeing Table 3) comparatively.(P＜0.01)

The variation of table 3 chronic gastritis rat treatment back lamina muscularis mucosae gastris thickness

Group	Number of animals (only)	Lamina muscularis mucosae gastris thickness (um)
				Hole portion	Body
		Normal control group blank group is organized positive control medicine group for reagent thing small dose group for reagent thing heavy dose	10 15 12 12 12			40.4±4.35 55.63±10.30### 49.25±8.63** 39.19±9.21** 42.45±9.41	37，79±7.15 61.18±17.43### 53.07±9.59** 42.39±11.48** 45.24±5.29

Four, conclusion (of pressure testing)

The inflammation degree of non-treatment group (blank group) rat model gastric antrum portion, hole body boundary, body of stomach, glandular stomach and glandular stomach intersection mucosa increases the weight of than normal group, and is more obvious with gastric antrum portion and glandular stomach and glandular stomach intersection; Gastric antrum portion, the sticking flesh layer of body of stomach obviously thicken; The gastric juice Titrable acid also descends than normal group.Treatment group model rat is through (dosage is respectively 12.3g/kg for the reagent thing, 24.6g/kg) and positive control medicine (dosage is respectively 3.75g/kg) treatment 40 days, the inflammation degree of its gastric antrum portion, hole body boundary, body of stomach, glandular stomach and glandular stomach intersection gastric mucosa all alleviates than the blank group, and is more obvious with the effect of gastric antrum portion, hole body boundary, glandular stomach and glandular stomach intersection; The thickness for the treatment of treated animal gastric antrum, the sticking flesh layer of body of stomach simultaneously is also than the obvious attenuation of blank group; The gastric juice Titrable acid also returns near normal.But pepsin activity does not have evident difference in each treated animal gastric juice.Above result shows that Chinese medicine composition of the present invention has the good curing effect to experimental chronic gastritis.

[test example 2] Chinese medicine composition of the present invention is observed the experimental therapy of chronic atrophic gastritis rat

One, test material

(1) laboratory animal: the SD rat, body weight 200-213g, regular grade is provided by Department of Health of Guangdong Province medical experimental animal field, Guangdong Province's laboratory animal certification of fitness: No. 94022.

(2) medicine: 1. for the reagent thing: the granule that the embodiment of the invention 1 is prepared.2. positive control medicine: the vitacoenzyme coated tablet, the 0.2g/ sheet, lot number: 940708, the Taishan, Guangdong chemical pharmaceutical factory produces.All prepare during above drug study with distilled water.Vitacoenzyme removes coating earlier when preparation.

(3) main agents: 1. deoxycholic acid sodium salt.The 10g/ bottle, lot number: 920420.ser va company produces, the import packing of biological chemical reagent shop, Shanghai.

(4) animal experiment technique condition: animal observation ward is a regular grade, and zoopery condition in Guangdong Province's detects the certificate of competency, probatio inspectionem pecuoarem word: No. 9435.

Two, test method

(1) model preparation: only get rat SD80, male and female half and half, under the same conditions by the male and female sub-cage rearing, 5 in every cage, routine feeding standard particle feedstuff.Wherein 20 as the normal control group, and all the other animals carry out modeling.The modeling animal makes beverage with 0.2% sodium deoxycholate, every rat is irritated gastric irritation with the hot boiled water of 55 ℃ of 2ml every day, and in the 1st week of modeling and immunity once at every rat skin lower injection adjuvant antigen (the Emulsion 0.3ml that the normal saline tissue homogenate of gastric mucosa of rat of the same race and the complete Freund's adjuvant of equivalent are made into) the 5th week.During modeling, each treated animal routine feeding.Modeling is 90 days continuously, randomly draws before modeling finishes and carries out the pathology of gastric mucosa histological examination on a small quantity, after the success of affirmation model, finishes to carry out GP TH in modeling.

(2) laboratory animal grouping and treatment: the modeling animal is divided into four groups at random: the blank group, for reagent thing size dosage treatment group, vitacoenzyme treatment group, and establish the normal control group simultaneously, for 5 times, 10 times administrations (the suitable crude drug amount 12.3g/kg of reagent composition granule by clinical consumption, 24.6g/kg), be made into following dosage 1.23g/ml, 2.46g/ml respectively for the reagent thing; Vitacoenzyme is equivalent to crude drug amount 0.25g/kg by 5 times of administrations of clinical consumption per day, is made into the dosage of 0.025g/ml; The treatment treated animal is all irritated the Weishang by the 1.0ml/100g body weight and is stated medicine, and the blank group is irritated isopyknic distilled water, and be administered once every day, and continuous 60 days, each treated animal routine feeding carried out gastric analysis after administration finishes and histopathology is observed.

(3) observation index and method of testing

1. body weight change: duration of test, per two weeks weigh once, and off-test is each treated animal body weight change relatively, and according to body weight change banknotes-system curve chart.

2. gastric analysis: Drug therapy finishes, each treated animal fasting 24 hours (freely drinking water) is put to death animal with the cervical vertebra dislocation method, wins full stomach, flush away surface blood stains, blot with filter paper, cut gastral cavity open, with 5ml distilled water flushing gastral cavity along greater gastric curvature, and in above-mentioned washing liquid, embathe 3 times, the supernatant of gastric juice specimen is analyzed, used the titration measuring free acid, survey pepsin activity with wheat Te Shi method.

3. histopathology is observed: along lesser gastric curvature from glandular stomach to pylorus get one of holostrome coat of the stomach (3 * 10mm), use 10% formalin fixed, the routine paraffin wax section, HE dyes, and makes om observation.The inflammation degree is divided 4 grades (1-4 branches): " 1 " NIP; " 2 " have the inflammatory cell that is dispersed on a small quantity at stomach mazaedium or bottom; " 3 " all have more inflammatory cell at the gastric mucosa each several part; " 4 " have gathering cell infiltration in heaps in mucosa.Observe the holostrome gastric mucosa under low power lens, 10 visuals field are got in each section: comprise 4 in hole portion, 1 of hole body intersection, 4 of bodies, 1 of glandular stomach and glandular stomach intersection.Inflammation according to each visual field is divided progression, presses hole portion, hole body boundary, body, glandular stomach and four positions of glandular stomach intersection, gets its average and compares.Measure gastric mucosa thickness with micrometer, muscular layer of mucosa thickness is measurement unit with um, and 8 visuals field are got in each section, and each four of hole portion, bodies are asked the average of hole portion, body respectively, reflect the connective tissue proliferation situation with this.And measure the body of stomach gastric pits degree of depth and gastric gland length, get its ratio and compare.

Three, result of the test

(1) influence that rat body weight is changed

The modeling rat is since the 4th week, and the normal matched group of its body weight gain percentage rate reduces gradually, and the outward appearance hair color shows slightly drying, becomes thin.During 60 days Drug therapys of animal via, treatment group body weight gain rate increases than the blank group, serves as obviously with the vitacoenzyme group, and secondly for reagent composition granule low dose, heavy dose of group is near with blank winding.

(2) to the influence of free acidity and pepsin activity in the gastric juice

Table 4 chronic atrophic gastritis rat treatment back gastric juice Titrable acid. the variation of pepsin activity

Group	Number of animals (only)	Gastric juice Titrable acid (mmol/l)	Pepsin activity (active unit/ml)
				Normal control group blank group is organized the vitacoenzyme group for reagent thing small dose group for reagent thing heavy dose	10 11 13 10 10	10.96±3.06 8.04±2.60# 9.88±2.61 10.66±1.74* 11.30±3.16**	61.45±13.2 54.25±15.13 59.01±14.74 64.38±l8.79 52.86±22.43

Compare with normal group: #P＜0.05, compare with the blank group: * P＜0.05, * * P＜0.01

1. blank group rat stomach liquid Titrable acid obviously reduces than normal group, raises than the blank group for reagent composition granule treatment group, vitacoenzyme treatment group, and the effect of and vitacoenzyme treatment group heavy dose of for the reagent thing is obvious (table 4) comparatively.

2. respectively organize the white enzymatic activity no difference of science of statistics of stomach (table 4) in the rat gastric juice.

(3) pathology of gastric mucosa histological observation

1. perusal: the rats in normal control group gastric mucosa is light red, and surfacing is smooth, and the holostrome coat of the stomach is thicker, and feel elasticity is better.The sticking paler colour of blank treated animal stomach has not to be light grey, and the surface is with loose tongue shape thing, and dendritic blood vessel is easily seen under the thin mucosa of mucosa.For reagent composition granule and vitacoenzyme treatment group gastric mucosa kermesinus or light gray, have also with a small amount of tongue shape thing.

2. om observation:

The morphosis of finding gastric mucosa is identical with chronic gastritis normal control group under the normal arrangement of mirrors.The blank group in the gastric antrum portion lamina propria seen being dispersed in property lymphocyte and neutrophilic infiltration, and part animal cell infiltration is comparatively obvious.Between the little vasodilation hyperemia of matter.Mucosal thickness is than the obvious attenuation of normal group, and body of gland shortens or be thinner.Muscular layer of mucosa obviously thickens, the muscular layer of mucosa of part animal the hypertrophy that makes progress.Body of stomach gastric pits size, shape are inconsistent, and length increases, the obvious normal group of ratio of gastric pits and body of gland length.Being dispersed in property lymphocyte and neutrophil infiltration are on a small quantity arranged, obviously in the lamina propria with the mucosa bottom.Between the little vasodilation hyperemia of matter.The lamina propria body of gland of part animal expansion or form cryptomere, the cyst wall cell volume diminishes or is comparatively flat, the parietal cell number slightly reduces, muscular layer of mucosa obviously thickens, and have muscular layer of mucosa make progress hypertrophy, cut apart and hold the lamina propria phenomenon.

Compare with blank group for reagent composition granule, vitacoenzyme treatment group, the congested degree of the cell infiltration of hole portion and body and little vasodilation alleviates, and portion is more obvious with hole; The gastric pits size is more consistent, and length reduces, and gastric pits and body of gland length ratio reduce to some extent than the blank group, and is comparatively obvious with the effect of vitacoenzyme group, secondly is for reagent composition granule small dose group, then changes not obvious for the heavy dose of group of reagent composition granule; Gastric mucosa thickness treatment group also increases than the blank group, and is comparatively obvious with the increase of heavy dose group and vitacoenzyme group; Mucomembranous skin thickness also than the obvious attenuation of blank group, the results are shown in Table 5.6.

The variation of table 5 chronic atrophic gastritis rat treatment back each inflammation of gastric mucosa

Group	The inflammation degree
					Hole portion	The hole body has a common boundary	Body	Glandular stomach and glandular stomach have a common boundary
	Normal control group blank group is organized the vitacoenzyme group for reagent thing small dose group for reagent thing heavy dose	1.54±0.49 1.98±0.16## 1.75±0.23* 1.68±0.20* 1.73±0.13*	1.20±0.14 1.53±0.51# 1.46±0.51 1.36±0.50 1.36±0.51	1.40±0.54 1.56±0.21 1.42±0.17 1.43±0.20 1.36±.21					1.40±0.54 1.81±0.40# 1.84±0.38 1.82±0.40 1.64±0.50

Annotate: 1.* (#): P＜0.05** (##): P＜0.01 (following same meaning)

Table 6 chronic atrophic gastritis rat treatment back gastric mucosa, mucomembranous skin thickness, the variation of gastric pits and body of gland length ratio

Group	Mucosal thickness (X ± SD)		Mucomembranous skin thickness (um, X ± SD)		Gastric pits length is than body of gland length
						Hole portion	Body	Hole portion	Body
	Normal control group blank group supplies the heavy dose of group of examination vitacoenzyme group for the examination small dose group	348.9±32.9 278.1±32.1## 306.1±42.3 329.1±31.5** 327.4±29.1**	602.6±92.6 630.4±61.4 680.3±77.0 709.6±39.3 702.5±67.3	31.91±5.58 46.38±7.61## 41.03±7.45 36.17±6.35* 37.59±8.12*	28.81±15.70 56.67±14.83### 45.58±10.20* 44.38±10.85* 43.60±7.18**						0.26±0.02 0.34±0.05## 0.30±0.05 0.32±0.04 0.28±0.05*

Annotate: ###P＜0.001

The inflammation degree of non-treatment group (blank group) rat model gastric mucosa increases the weight of than normal group, and is comparatively obvious with gastric antrum portion and glandular stomach and glandular stomach intersection; The obvious attenuation of gastric antrum portion mucosal thickness, gastric antrum portion, body of stomach muscular layer of mucosa then obviously thicken; Gastric pits and gastric gland body length ratio obviously increase; The gastric juice Titrable acid descends.The sticking flesh layer of body of stomach obviously thickens; The gastric juice Titrable acid also descends than normal group.Treatment group model rat is through treating 60 days for reagent thing and vitacoenzyme, and the more non-treatment group of its stomach lining inflammation alleviates, and improves comparatively obvious with gastric antrum portion inflammation; Gastric antrum portion mucosal thickness obviously increases simultaneously, and gastric antrum portion, body of stomach muscular layer of mucosa thickness are also than the obvious attenuation of blank group; The blank group of the ratio of gastric pits and body of gland length reduces to some extent; The gastric juice Titrable acid returns to normal level.

In sum, the chronic atrophic gastritis rat is through Drug therapy of the present invention after 60 days, the histopathology variation of gastric mucosa is clearly better, showing as the more non-treatment group of treatment group stomach lining inflammation alleviates, the more non-treatment group of gastric mucosa thickness obviously increases, muscular layer of mucosa thickness is obviously attenuation then, and the gastric juice Titrable acid recovers to some extent simultaneously, and The above results shows that medicine of the present invention has therapeutical effect preferably to experimental chronic atrophic gastritis.

[test example 3] Chinese medicine composition prevention MNNG of the present invention brings out the experiment of rat glandular stomach cancer precancerous lesion effect

One, the foundation of rat glandular stomach cancer precancerous lesion model

(1) MNNG solution preparation:

Reagent: N-methyl-N '-nitro-N-nitrosoguanidine (N-Methl-N-nitro-N-nitrosofuanidine, MNNG), Fluka company produces, lot number: 327080 1493.Faint yellow crystallization product, 4 ℃ of refrigerators are preserved.

Get MNNG2g in beaker, add distilled water 2000ml, put on the magnetic stirring apparatus and stir, until medicine dissolution (about 3 to 4 hours), promptly get and contain MNNG1g/L storage liquid (mother solution), preserve under 4 ℃ of refrigerator lucifuges, with 10 times of tap water dilutions, be the solution (whole liquid) that contains MNNG100ug/ml during use.All process for preparation all needs lucifuge.Mother solution was joined once in 5 days, and whole liquid is joined once every day.

(2) laboratory animal and raising condition:

120 of pure lines Wistar rats, male, the about 100 ± g of body weight is available from No.1 Military Medical Univ.'s Animal House.Divide cage to feed 5 in every cage, the commercially available pellet of feed.Routine begins experiment after raising January.Be coated with the drinking-water bottle with lucifuge with the dirty oil lacquer, 100mg/ml MNNG solution is poured in the bottle, drink for rat.Renew bright MNNG liquid every day, room temperature is controlled at 22-28 ℃.Rat is weighed once weekly, and keeps cage tool cleaning.

(3) pathological diagnosis and observation thereof:

From experiment, all dead rats all do postmortem.Stomach is drawn materials, and 10% formalin solution is fixed, specimens paraffin embedding slices, and conventional H E dyeing, microscopically is observed mucosa infection.

Since the 14th weekend, every randomly drawing 7 of rats 2 weeks, fasting be can't help water 24 hours, pentobarbital sodium 20mg/kg intramuscular injection anesthesia after the ether light anaesthesia, the skin of abdomen sterilization is cut open the belly, get gland lesser gastric curvature one fritter (hole portion) holostrome and do pathological section, microscopically is observed mucosa infection.Postoperative rat fasting again be can't help water 24 hours, conventional then the raising.Promptly randomly draw 42 of rats (each 7) altogether and do biopsy, observe its pathological change process the 14th, 16,18,20,22,24 weekends.

Two, animal grouping and medication

(1) preparation of experiment medicine and solution thereof

For the reagent thing: the dry extract that the embodiment of the invention 1 is prepared, the 1g dry extract is equivalent to 7.14g gram crude drug, and adult's dosing every day is equivalent to dry extract 19.2g.

Positive control drug: vitacoenzyme, produce lot number 940702 by the Taishan, Guangdong chemical pharmaceutical factory.Every 0.2g of vitacoenzyme coated tablet, clinical adult every day 4 times, each 4.

(2) laboratory animal grouping, medication and method for breeding

Different dosing group rat weigh respectively (1 time weekly), calculate and need dose every day, for reagent thing heavy dose is that (this dosage was to give the rat dosage every day in 4.8g dry extract/kg/50ml/ days, calculate with rat body weight, every kg gives the 4.8g dry extract, these dry extracts all are dissolved in the 50ml water, feed to rat), low dose of: 1.6g dry extract/kg/50ml/ days (15 times, 5 times of quite clinical consumption respectively), vitacoenzyme 0.53g/kg/50ml/ days (being equivalent to 10 times of clinical consumptions), medicine is dissolved in a certain amount of water.By the administration of every group of every cage rat body weight.Change with body weight weekly and adjust dosage.

The 25th week of all modeling rats first day random packet, be divided into 29 of blank groups, for 27 of the heavy dose of groups of reagent thing, for 27 of reagent thing small dose group, 26 of vitacoenzyme groups.5 of every afternoons are to point in mornings 8 next day, and each experimental group gives corresponding medicinal liquid for freely drinking (blank group drink tap water) respectively, mornings 8 next day point, determine that a bottle inner liquid medicine has been drunk after, change tap water and supply freely to drink to point in afternoons 5.Each group is control amount of drinking water every day suitably, to guarantee that treating medicinal liquid every day has all drunk.Medicine ended from 25 week to 36 weekends.Experimental session gives commercially available pellet and feeds.Room temperature is controlled at 22-28 ℃.

(3) observational technique and index

Dead rat all does postmortem during testing for the 25th thoughtful 36 weekends, observe intraperitoneal pathological changes situation, get full stomach and suspicious organs and tissues with 10% formalin fixed, suspicious lesions and tumor predilection site are drawn materials with other suspicious internal organs, specimens paraffin embedding slices, conventional H E dyeing, ordinary optical microscope is observed stomach and other organ disease.

Test the 33rd all every group put to death 4 of rats at random, 4 groups totally 16.Observe the pathologic condition of animal stomach during treating.

All put to death survival rats 36 weekends, laparotomy exploration stomach, intestinal, liver and abdominal cavity pathological changes situation, measure, the tumorigenic position of rat respectively organized in record, number, size, type and transfer case substantially, the typical case that typical tumor and tumor are caused shows photographic recording.Do the pathology inspection with said method, types of organization, differentiation degree, growth pattern and the intramural invasion of rat tumor respectively organized in record.

Three, result of the test

According to biopsy result during the modeling, MNNG freely feeds the drink rat, brings out rat to 20 thoughtful 24 Zhou Houneng the precancerous lesion of glandular stomach cancer takes place.After stopping drinking MNNG, continue to feed the drink tap water, supply reagent and positive control drug to 36 week, perusal and tissue slice pathologic finding find that the lotus tumor appears in the rat glandular stomach, it is obvious wherein to feed drink tap water group rat tumor intramural invasion, there are 3 to reach progressive stage or advanced carcinoma, illustrate and stop drinking that rat canceration process is still continuing development behind the MNNG.After rat stops drinking MNNG, feed drink and supply reagent thing three months, pathological examination results is found for the low dose of continuation development that can block glandular stomach cancer precancerous lesion effectively in 12 weeks of administration of reagent thing.Result of the test shows that Chinese medicine composition of the present invention has the effect of control rat glandular stomach precancerous lesion.

The III phase clinical observation on the therapeutic effect of [test example 4] traditional Chinese medicine composition for treating chronic atrophic gastritis of the present invention

Medicine II clinical trial phase of the present invention shows: with drug particles of the present invention with each oral 7g, every day 3 times, treat chronic atrophic gastritis (deficiency of both QI and YIN hold concurrently stagnant heat in knot card) on the dosage in continuous use March and the basis of the course of treatment, determined curative effect, patient's syndrome (is comprised cardinal symptom: the gastral cavilty feeling of fullness, scorching hot and the minor symptom of gastralgia and gastral cavilty: upset in the stomach, localized pain, spiritlessness and weakness, indigestion and loss of appetite lack of appetite, dry mouth with bitter taste and constipation with dry stool) all be significantly improved, to gastroscopy and the suggested atrophy of biological tissue pathologic finding, inflammation, intestinalization and atypical hyperplasia etc. all have clearly to be improved, onset time generally was no more than for 1 week, was certain time-effect relationship in 3 months the course of treatment.Do not see any toxic and side effects and the serious adverse events of drug-induced in the II clinical trial phase, safety is good.II clinical trial phase result shows the effective and safe drug of medicine of the present invention for the treatment chronic atrophic gastritis.

On the basis of II clinical trial phase, carried out the III phase clinical observation on the therapeutic effect test of Drug therapy chronic atrophic gastritis of the present invention, concrete observational technique and observed result are as follows:

The III clinical trial phase adopt parallel control, at random, the method for designing of double blinding, multiple center trial.Whole test is finished by domestic 4 hospital national drug clinical research bases are collaborative.

One, physical data

Be not less than 300 examples according to " new Chinese medicine clinical research specification requirement " III clinical trial phase test group case load, consider to be no more than 20% the rate that withdraws from simultaneously, test group and matched group are gone into group at random in 3: 1 ratio.So the sample size of this test is defined as 480 examples, wherein 360 examples are organized in treatment, matched group 120 examples.At aspects such as age, sex, the course of disease, severity extent, tcm syndrome, gastroscope and pathologic findings, learn to handle by statistics before two groups of treatments, P all＞O.05, the difference not statistically significant illustrates between two groups to have comparability.

(1) case source and each center experimenter's distribution situation: as shown in table 7.

Each center experimenter's distribution situation of table 7

The center	The treatment group				Matched group				Add up to
													Selected	IT T	PP	Come off, reject	Selected	IT T	PP	Come off, reject	Selected	IT T	PP	Come off, reject
	1	75	75	75	0	25	25	25	0	100	100	100													0
2													72	72	72	0	24	24	24	0	96	96	96	0
	3	90	90	82	8	30	30	26	4	120	120	108													12
4													9O	99	99	l	3l	30	30	l	121	119	119	2
	Add up to	327	326	318	9	110	109	105	5	437	435	423													14

Annotate: test center: l refers to No.1 Hospital of Guiyang Traditional Chinese Medicine College; 2 refer to Shanxi Institute of Traditional Chinese Medicine; 3 refer to Gansu Affiliated Hospital of the college of traditional Chinese medicine; 4 refer to Hospital Affiliated To Chengdu Traditional Chinese Medicine Univ.

(2) two groups of case rejectings, dropping situations compare: as shown in table 8.

Table 8 a liang group comes off, rejects case relatively

Group	Include total routine number in	Finish the routine number of observation by scheme	Come off, reject routine number	Statistic	P
						Treatment group matched group	327 110	318 105	9 5	(0.3732 corrected X 2)	O.5413

Treatment group and matched group come off, reject the case situation by statistics credit analyse P＞O.05, difference not statistically significant.

(3) come off, reject among the selected experimenter person-time, time, reason and the statistical data analysis collection that entered thereof be as shown in table 9.

Table 9 test performance and system juice analytical data collection

Group	Selected	Reject	Come off	Finish routine number by scheme	Efficacy analysis		Safety analysis
								ITT	PP
					Treatment group matched group adds up to	327 110 437				0 1 2	9 4 12	318 105 423	326 109 435	318 105 423	326 109 435

Two, diagnose dialectical standard

1. doctor trained in Western medicine chronic atrophic gastritis diagnostic criteria: formulate with reference to " the clinical research guideline of new Chinese medicine treatment chronic atrophic gastritis ", " gastroenterology " (Pan state suzerainty compiles, and publishes in 1996) and in May, 2000 Jinggang Mountain " national chronic gastritis seminar common recognition suggestion " related content.

2. the traditional Chinese medical science deficiency of both QI and YIN dialectical standard of knot card in the stagnant heat of holding concurrently: formulate with reference to related content in " the clinical research guideline of new Chinese medicine treatment chronic atrophic gastritis ", " the clinical research guideline of new Chinese medicine treatment syndrome of spleen-deficiency ", " the clinical research guideline of new Chinese medicine treatment gastric abscess ", " the clinical research guideline of new Chinese medicine treatment epigastric fullness ".

Three, test case standard

1, includes the case standard in

(1) meets doctor trained in Western medicine chronic atrophic gastritis or companion's intestinal epithelial metaplasia or atypical hyperplasia (slight, moderate) diagnostic criteria person.

(2) meet the traditional Chinese medical science deficiency of both QI and YIN dialectical standard of knot card in the stagnant heat (before the treatment tcm syndrome integration and more than 9 minutes) of holding concurrently.

(3) age: 18-65 year.

(4) including preceding 2 weeks of test in interior is chronic atrophic gastritis through gastroscope and pathological diagnosis, or companion's intestinal epithelial metaplasia or atypical hyperplasia person.

Do not participate in other clinical trial persons in (5) 2 weeks.

(6) taken the treatment of other related drugs but more than 2 weeks of drug withdrawal.

(7) informed consent, aspiration is tried.Obtain the Informed Consent Form process and should meet the GCP regulation.

Allly meet above-mentioned seven point plan person, can include the test case in.

2, get rid of the case standard

(1) through gastroscope and pathologic finding ulcer, gastric cancer or non-atrophic gastritis person are arranged.

(2) chronic atrophic gastritis companion atypical hyperplasia (severe) person.

(3) gestation or women breast-feeding their children.

(4) allergic constitution or to this medicine constituent has allergies person.

(5) be associated with serious primary disease such as cardiovascular and cerebrovascular vessel, liver, kidney, pancreas and hemopoietic system, psychotic.

3, case is rejected and is come off:

(1) including the back in finds not meet chronic atrophic gastritis (deficiency of both QI and YIN hold concurrently stagnant heat in knot card) the dialectical standard of diagnosis and is not included in the person by mistake.

(2) not medication in accordance with regulations can't be judged curative effect, or data is not congruent affects the treatment or safety judgement person.

(3) to medicine group part allergy sufferers.Naturally come off in the observation, lose and visit or death cases.

(4) improper broken blind indivedual cases in the blind trial.

(5) experimenter's compliance poor, serious adverse events takes place, difficult continuation reception test person such as complication or special physiological variation and bolter are voluntarily taken place.

(6) drug combination in the non-prescribed limit particularly share the bigger medicine of trial drug influence, influences effectiveness or safety judgement person.

Four, therapeutic scheme

1, trial drug: (1) is for the reagent thing: the granule that the embodiment of the invention 1 is prepared.(2) positive control medicine: (Pharmaceutical Factory, Bethune Medical Univ. produces the WEILEXIN granule, and authentication code: the accurate word Z22023628 of traditional Chinese medicines), standard is numbered WS ₃-B-2183-96.Main component is a Hericium erinaceus (Bull. Ex Fr.) Pers. extractum.It is close with Chinese medicine composition of the present invention that its function cures mainly, and is the comparatively sure similar medicine of present domestic curative effect, meets to generally acknowledge that effectively similar comparable principle is so this test selects for use it as positive control drug

2, observational technique:

Test is adopted at random, double blinding, positive drug parallel control, polycentric test method, select the sex in age 18-65 year, the hold concurrently diagnosis of knot card in the stagnant heat, the sufferer of dialectical standard of the deficiency of both QI and YIN that meets chronic atrophic gastritis is the object of observation, after the random assortment experimenter enters test group or matched group, accept the Drug therapy in 3 months (12 week).Every example is tried patient and taken a kind of medicine according to random number, and is each 1 bag, every day 3 times, oral.Other similar medicines are used in the duration of test nonjoinder.

Test is by observing the variation that sufferer is treated forward and backward tcm syndrome, helicobacter pylori inspection (urease methods), gastroscopy and biological tissue pathologic finding, and the safety of observing the forward and backward patient of medication detects the variation of index and the not generation of adverse events is arranged, and with the dependency of trial drug, simultaneously with reference substance relatively, estimate gastritis the disappear curative effect and the safety of treatment chronic atrophic gastritis (deficiency of both QI and YIN hold concurrently stagnant heat in knot card).

Five, curative effect determinate standard

(1), gastroscopic observation curative effect

(1) clinical recovery: gastroscope confirms that the recovery of chronic atrophic gastritis gastric mucosa situation is normal or disappears.

(2) produce effects: gastroscope confirms chronic atrophic gastritis gastric mucosa atrophy situation improvement 2 degree.

(3) effective: gastroscope confirms chronic atrophic gastritis gastric mucosa atrophy situation improvement 1 degree.

(4) invalid: as not increase the weight of even the gastroscope finding has to improve.

(2), biological tissue pathology curative effect

1, the curative effect of body of gland atrophy

(1) clinical recovery: biopsy confirms that the body of gland atrophy recovers normal or disappearance.

(2) produce effects: biopsy confirms that the body of gland atrophy improves 2 degree.

(3) effective: biopsy confirms that the body of gland atrophy improves 1 degree.

(4) invalid: as not increase the weight of even histology's finding has to improve.

2, to the curative effect of intestinalization

(1) clinical recovery: biopsy confirms that intestinal epithelial metaplasia recovers normal or disappearance.

(2) produce effects: biopsy confirms that intestinal epithelial metaplasia improves 2 degree.

(3) effective: biopsy confirms that intestinal epithelial metaplasia makes moderate progress, but does not reach 2 degree.

(4) invalid: as not increase the weight of even histology's finding has to improve.

3, to the curative effect of atypical hyperplasia:

(1) clinical recovery: biopsy confirms that the atypical hyperplasia recovery is normal or disappears.

(2) produce effects: biopsy confirms atypical hyperplasia improvement 2 degree.

(3) effective: biopsy confirms atypical hyperplasia improvement 1 degree.

(4) invalid: as not increase the weight of even histology's finding has to improve.

4, to the curative effect of inflammation:

(1) clinical recovery: inflammation disappears.

(2) produce effects: inflammation degree improvement 2 degree.

(3) effective: the mucosa infection scope is dwindled more than 1/2, inflammation degree improvement 1 degree.

(4) invalid: even do not reach effective standard deterioration person on the contrary.

(3), the curative effect of tcm syndrome

1, the curative effect of tcm syndrome

Therapeutic index=(before treating the syndrome integration and-treat back syndrome integration and)/syndrome integration and * 100% before treating

(1) clinical recovery: after medication 1 course of treatment, sings and symptoms disappear substantially (therapeutic index 〉=90%).

(2) produce effects: after medication 1 course of treatment, sings and symptoms obviously improves (90%＞therapeutic index 〉=70%).

(3) effective: after medication 1 course of treatment, sings and symptoms has and improves (70%＞therapeutic index 〉=30%).

(4) invalid: after medication 1 course of treatment, sings and symptoms does not have obviously and alleviates (therapeutic index＜30%).

2, individual event symptom curative effect:

(1) clinic control: transference cure.

(2) produce effects: symptom take an evident turn for the better (6 minutes → 2 minutes or 3 minutes → 1 minute).

(3) effective: symptom take a turn for the better to some extent (6 minutes → 4 minutes, 4 minutes → 2 minutes or 3 minutes → 2 minutes, 2 minutes → 1 minute).

(4) invalid: symptom does not have the change or the person of increasing the weight of.

(4) safety evaluatio standard

1 grade: safety, there is not any untoward reaction.

2 grades: compare safety,, need not do any processing and can continue administration if any untoward reaction.

3 grades: safety issue is arranged, moderate untoward reaction is arranged, can continue administration after processing.

4 grades: because of test is ended in untoward reaction.

Five, observation of curative effect result

(1) gastroscopic observation curative effect

Treatment back gastroscope points out two groups of chronic atrophic gastritis patient curative effects relatively shown in table 10 (PP):

The two groups of gastroscopic observation curative effects in table 10 treatment back are (pp) relatively

Group	The example number	The gastroscopic observation curative effect				Cure-remarkable-effectiveness rate (%)	Effective percentage (%)
								Clinical recovery	Produce effects	Effectively	Invalid
		Treatment group matched group	313 ％ 104 ％	39 12.46 4 3.85	41 13.10 3 2.88							119 38.02 26 25.00	114 36.42 71 68.27	25.56 6.73	63.58 31.73

^*Annotate: the case load that gastroscope is pointed out atrophy and finished observation and check by scheme before referring to treat.

Two groups of patient's gastroscope prompting curative effects compare, through rank test, and Hc=33.9706, df=1, p=0.0000, P＜0.05, difference has statistical significance.According to the principle of binomial distribution as can be known:

The treatment group: cure-remarkable-effectiveness rate 25.56% (95% confidence interval: 20.819%～30.769%), total effective rate 63.58% (95% confidence interval: 57.979%～68.918%);

Matched group: cure-remarkable-effectiveness rate 6.73% (95% confidence interval: 2.749～13.377%), total effective rate 31.73% (95% confidence interval: 22.949%～41.584%).

Two groups of curative effects credit are by statistics analysed and are shown that the treatment group is better than matched group (P＜0.05) to chronic atrophic gastritis (deficiency of both QI and YIN hold concurrently stagnant heat in knot card) patient's gastroscopy effect.

(2) pathology curative effect

1, atrophy curative effect

The atrophy curative effect of two groups of patient's pathologic finding promptings is shown in table 11 (PP):

Table 11 liang group patient's atrophy curative effect (pathology) is (PP) relatively

Group	The example number *	Atrophy curative effect (pathology)				Cure-remarkable-effectiveness rate (%)	Effective percentage (%)
								Clinical recovery	Produce effects	Effectively	Invalid
		Treatment group matched group	313 ％ 104 ％	46 14.70 8 7.69	26 8.31 1 0.96							135 43.13 31 29.81	106 33.87 64 61.54	23.00 8.65	66.13 38.46

* annotate: sick inspection prompting atrophy and finish the case load of observing and checking by scheme before referring to treat.

The atrophy curative effect of two groups of patient's pathologic finding promptings compares, through rank test, and Hc=24.7460, df=1, p=0.0000, P＜0.05, difference has statistical significance.

The treatment group: cure-remarkable-effectiveness rate 23.00% (95% confidence interval: 18.456%～28.069%), total effective rate 66.13% (95% confidence interval: 60.598%～71.362%); Matched group: cure-remarkable-effectiveness rate 8.65% (95% confidence interval: 4.034%～15.793%), total effective rate 38.46% (95% confidence interval: 29.086%～48.512%).

Two groups of curative effects credit are by statistics analysed and are shown that the treatment group is better than matched group (P＜0.05) to chronic atrophic gastritis (deficiency of both QI and YIN hold concurrently stagnant heat in knot card) patient's atrophy (pathology) curative effect.

2, inflammation curative effect

The inflammation curative effect of two groups of patient's pathologic finding promptings is shown in table 12 (PP):

The table 12 treatment two groups of chronic atrophic gastritis patient inflammation curative effects in back (pathology) are (PP) relatively

Group	The example number *	Inflammation curative effect (pathology)				Cure-remarkable-effectiveness rate (%)	Effective percentage (%)
								Clinical recovery	Produce effects	Effectively	Invalid
		Treatment group matched group	299 ％ 96 ％	33 11.04 8 8.33	47 15.72 7 7.29							124 41.47 29 30.21	95 31.77 52 54.17	26.76 15.63	68.23 45.83

Two groups of patient's pathology prompting inflammation curative effects compare, through rank test, and Hc=13.5340, df=1, p=0.0002, P＜0.05, difference has statistical significance.According to the principle of binomial distribution as can be known:

The treatment group: cure-remarkable-effectiveness rate 26.76% (95% confidence interval: 21.823%～32.156%), total effective rate 68.23% (95% confidence interval: 62.621%～73.468%); Matched group: cure-remarkable-effectiveness rate 15.63% (95% confidence interval: 9.017%～24.458%), total effective rate 45.83% (95% confidence interval: 35.617%～56.314%).

Two groups of curative effects credit are by statistics analysed and are shown that the treatment group is better than matched group (P＜0.05) to chronic atrophic gastritis (deficiency of both QI and YIN hold concurrently stagnant heat in knot card) patient's inflammation (pathology) curative effect.

3, the intestinal chemotherapy is imitated

The intestinal chemotherapy of two groups of patient's pathologic finding promptings is imitated shown in table 13 (PP):

Table 13 a liang group patient intestinal chemotherapy is imitated (pathology) relatively

Group	The example number *	The intestinal chemotherapy is imitated (pathology)				Cure-remarkable-effectiveness rate (%)	Effective percentage (%)
								Clinical recovery	Produce effects	Effectively	Invalid
		Treatment group matched group	158 ％ 54 ％	68 43.04 15 27.78	0 0.00 0 0.00							23 14.56 7 12.96	67 42.41 32 59.26	43.04 27.78	57.59 40.74

^*Annotate: the case load of sick inspection prompting intestinalization before referring to treat.

Two groups of patient's pathology prompting intestinal chemotherapy are imitated relatively, through rank test, and Hc=4.8649, df=1, p=0.0274, P＜0.05, difference has statistical significance.

The treatment group: cure-remarkable-effectiveness rate 43.04% (95% confidence interval: 35.198%～51.144%), total effective rate 57.59% (95% confidence interval: 49.491%～65.408%); Matched group: cure-remarkable-effectiveness rate 27.78% (95% confidence interval: 16.455%～41.644%), total effective rate 40.74% (95% confidence interval: 27.56%～54.966%).

Two groups of curative effects credit are by statistics analysed and are shown that the treatment group is better than matched group (P＜0.05) to chronic atrophic gastritis (deficiency of both QI and YIN hold concurrently stagnant heat in knot card) patient's intestinalization (pathology) curative effect.

4, atypical hyperplasia curative effect

The atypical hyperplasia curative effect of two groups of patient's pathologic finding promptings is shown in table 14 (PP):

Table 14 liang group patient's atypical hyperplasia curative effect (pathology) relatively

Group	The example number *	Atypical hyperplasia curative effect (pathology)				Cure-remarkable-effectiveness rate (%)	Effective percentage (%)
								Clinical recovery	Produce effects	Effectively	Invalid
		Treatment group matched group	31 ％ 13 ％	20 64.52 4 30.77	0 0.00 0 0.00							4 12.90 0 0.00	7 22.58 9 69.23	64.52 30.77	77.42 30.77

^*Annotate: the case load of sick inspection prompting atypical hyperplasia before referring to treat

The curative effect of two groups of patient's pathology prompting atypical hyperplasias compares, through rank test Hc=6.2005, and df=1, p=0.0128, P＜0.05, difference has statistical significance.

The treatment group: cure-remarkable-effectiveness rate 64.52% (95% confidence interval: 45.370%～80.773), total effective rate 77.42% (95% confidence interval: 58.904%～90.406%); Matched group: cure-remarkable-effectiveness rate 30.77% (95% confidence interval: 9.092%～61.426%), total effective rate 30.77% (95% confidence interval: 9.092%～61.426%).

Two groups of curative effects credit are by statistics analysed, and difference has statistical significance (P＜0.05), show that the treatment group is better than matched group to chronic atrophic gastritis (deficiency of both QI and YIN hold concurrently stagnant heat in knot card) patient's atypical hyperplasia (pathology) curative effect.

(3) therapeutic effect of syndrome

1, syndrome total effects

Two groups of chronic atrophic gastritis patient tcm syndrome curative effects are shown in table 15 (ITT), table 16 (PP):

The two groups of patient's tcm syndrome curative effects in table 15 treatment back are (ITT) relatively

Group	The example number	The tcm syndrome curative effect				Cure-remarkable-effectiveness rate (%)	Effective percentage (%)
								Clinical recovery	Produce effects	Effectively	Invalid
		Treatment group matched group	326 ％ 109 ％	49 15.03 7 6.42	189 57.98 51 46.79							75 23.01 41 37.61	l3 3.99 10 9.17	73.011 53.21	96.01 90.83

Two groups of patient's tcm syndrome curative effects (ITT) compare, through rank test, and Hc=16.9596, df=1, p=0.0000, P＜0.05, difference has statistical significance.

The treatment group: cure-remarkable-effectiveness rate 73.01% (95% confidence interval: 67.839%～77.750%), total effective rate 96.01% (95% confidence interval: 93.277%～97.860%); Matched group: cure-remarkable-effectiveness rate 53.21% (95% confidence interval: 43.411%～62.832%), total effective rate 90.83% (95% confidence interval: 83.775%～95.512%).Two groups of curative effects compare, and difference has statistical significance (P＜0.05)

The two groups of patient's tcm syndrome curative effects in table 16 treatment back are (PP) relatively

Group	The example number	The tcm syndrome curative effect				Cure-remarkable-effectiveness rate (%)	Effective percentage (%)
								Clinical recovery	Produce effects	Effectively	Invalid
		Treatment group matched group	318 ％ 105 ％	49 15.41 7 6.67	189 59.43 51 48.57							73 22.96 41 39.05	7 2.20 6 5.71	74.84 55.24	97.80 94.29

Two groups of patient's tcm syndrome curative effects (PP) compare, through rank test, and Hc=16.5126, df=1, p=0.0000, P＞0.05, difference not statistically significant.

Cure-remarkable-effectiveness rate 74.84% (95% confidence interval: 69.698%～79.518%), total effective rate 97.80% (95% confidence interval: 95.517%～99.111%); Matched group: cure-remarkable-effectiveness rate 55.24% (95% confidence interval: 45.220%～64.953%), total effective rate 94.29% (95% confidence interval: 87.977%～97.874%).Two groups of curative effects compare, and difference has statistical significance (P＜0.05).

Show that the treatment group is better than matched group to chronic atrophic gastritis (deficiency of both QI and YIN hold concurrently knot card in the stagnant heat) patient's tcm syndrome curative effect.

2, syndrome onset time and curative effect curve

The variation of two groups of patient's tcm syndrome integrations is shown in table 17, table 18.

Table l7 treats forward and backward tcm syndrome integration relatively for two groups

	The treatment group			Matched group
							Sample number	Average	Standard deviation	Sample number	Average	Standard deviation
	The treatment before the treatment 1W after the treatment 3W after the treatment 5W after the treatment 7W after the treatment 9W after the treatment 11W after the treatment 12W after	326 326 326 322 318 318 318 318	20.83 18.29 15.06 12.65 10.66 8.66 6.75 5.15	6.48 6.19 5.95 5.62 5.17 4.61 4.04 3.61	109 109 109 106 105 l05 105 105	21.62 18.90 16.10 13.89 11.73 10.99 8.77 7.34							6.38 6.35 6.27 6.11 5.75 7.99 5.42 5.01
ITT difference PP							326 318	15.49 15.81	6.22 5.95	109 105	14.06 14.59	5.93 5.35

Annotate: " W " is the designate in " week " in the table.

Table 18 liang each treatment stage syndrome integration statistical result of group

The treatment group				Matched group
							The homogeneity test of variance analysis of variance table	X 2＝183.2431 KW＝1276.5610	P=0.0000 is similar to X 2The test of significance that distributes, p=0.0000		X 2＝29.12431 KW＝323.5938	P=0.0001 is similar to X 2The test of significance that distributes, p=0.0000
Compare between group	Poor between group	The t value	Significant level	Poor between group	The t value	Significant level
							Before the treatment＜-〉 1w after behind the 1w＜-〉 3w after behind the 3w＜-〉 5w after behind the 5w＜-〉 7w after behind the 7w＜-〉 9w after behind the 9w＜-〉 11w after behind the 11w＜-〉 treatment after	171.70 274.21 238.54 214.96 237.03 231.75 202.58	4.1823 6.6790 5.7922 5.1873 5.7021 5.5752 4.8733	0.0000 0.0000 0.0000 0.0000 0.0000 0.0000 0.0000	70.43 82.77 72.73 75.64 42.32 65.64 51.89	2.6837 3.1537 2.7518 2.8357 1.5827 2.4548 1.9404	0.00742 0.00167 0.00605 0.00468 0.11387 0.01430 0.05266

Annotate: " W " is the designate in " week " in the table.

By, treatment 1 week back preceding to treating, 3 week the back, 5 week the back, 7 week the back, 11 week back and the analysis showed that of the tcm syndrome scoring when finishing the course of treatment: two groups of patients' tcm syndrome integration all has remarkable decline (P＜0.01) after 1 week of treatment, the treatment group is whenever in the syndrome integration significant level (P＜0.01) that all descended than the previous stage of treatment the latter half, the syndrome onset time that shows Drug therapy chronic atrophic gastritis of the present invention (deficiency of both QI and YIN hold concurrently knot card in the stagnant heat) was no more than for 1 week, and was certain time-effect relationship in the course of treatment in March.The reduction value of treatment back treatment group tcm syndrome integration is 15.81 ± 5.95 (ITT:15.49 ± 6.22), the reduction value of matched group is 14.59 ± 5.35 (ITT:14.06 ± 5.93), two groups of tcm syndrome integrations and reduction value are learned processing by statistics, and difference has statistical significance (P＜0.05).

The tcm syndrome integration differential is relatively before and after two groups of treatments:

The ITT data set: through the t check, two handle homogeneity of variance (p=0.5617), and its average significance test of difference is t=2.1149 as a result, p=0.0350, and difference has statistical significance.

The PP data set: through the t check, two handle homogeneity of variance (p=0.2019), and its average significance test of difference is t=1.8593 as a result, p=0.0637, and difference has statistical significance.

Comprehensive above-mentioned data illustrate before and after the treatment group treatment that improvement to the tcm syndrome integration is greater than matched group.

(4) symptom curative effect

1, tcm symptom classification curative effect

Each tcm symptom Grading treatment of treatment group and matched group is forward and backward through rank test, and the P value is all less than 0.05, and it is remarkable to treat forward and backward differences, medication is described after two groups of each symptoms of the traditional Chinese medical science all significantly improve.

2, cardinal symptom curative effect (PP)

A gastral cavilty feeling of fullness curative effect: the results are shown in Table 19.

Table 19 liang group patient gastral cavilty feeling of fullness curative effect

Group	The example number	Gastral cavilty feeling of fullness curative effect				Cure-remarkable-effectiveness rate (%)	Effective percentage (%)
								Clinical recovery	Produce effects	Effectively	Invalid
		Treatment group matched group	301 ％ 102 ％	76 25.25 24 23.53	83 27.57 29 28.43							114 37.87 37 36.27	28 9.30 12 11.76	52.82 51.96	90.70 88.24

Two groups of patient's gastral cavilty feeling of fullness curative effects compare, Hc=0.1740, and df=1, p=0.6766, P＞0.05, the difference not statistically significant illustrates that two groups of gastral cavilty feeling of fullness curative effects are similar.

B gastralgia curative effect: shown in table 20.

Table 20 liang group patient gastralgia curative effect relatively

Group	The example number	The gastralgia curative effect				Cure-remarkable-effectiveness rate (%)	Effective percentage (%)
								Clinical recovery	Produce effects	Effectively	Invalid
		Treatment group matched group	300 ％ 101 ％	216 72.00 54 53.47	33 11.00 20 19.80							30 10.00 19 18.81	21 7.00 8 7.92	83.00 73.27	93.00 92.08

Two groups of patient's gastralgia curative effects compare, Hc=10.1293, and df=1, p=0.0015, P＜0.05, difference has statistical significance, illustrates that treatment group gastralgia curative effect is better than matched group.

The scorching hot curative effect of C gastral cavilty: shown in table 21.

The scorching hot curative effect of the two groups of patient's gastral cavilties in table 21 treatment back is (PP) relatively

Group	The example number	The scorching hot curative effect of gastral cavilty				Cure-remarkable-effectiveness rate (%)	Effective percentage (%)
								Clinical recovery	Produce effects	Effectively	Invalid
		Treatment group matched group	277 ％ 95 ％	189 68.23 47 49.47	16 5.78 15 15.79							51 18.41 20 21.05	21 7.58 13 13.68	74.01 65.26	92.42 86.32

Two groups of scorching hot curative effects of patient's gastral cavilty compare, Hc=8.8860, and df=1, p=0.0029, P＜0.05, difference has statistical significance, illustrates that the scorching hot curative effect of treatment group gastral cavilty is better than matched group.

In sum, medicine of the present invention to the curative effect of chronic atrophic gastritis (deficiency of both QI and YIN hold concurrently knot card in the stagnant heat) patient's cardinal symptom is respectively: the cure-remarkable-effectiveness rate 52.82% of gastral cavilty feeling of fullness, total effective rate 90.70%; The cure-remarkable-effectiveness rate 83.00% of gastralgia, total effective rate 93.00%; The cure-remarkable-effectiveness rate 74.01% that gastral cavilty is scorching hot, total effective rate 92.42%.With matched group relatively, medicine of the present invention is better than positive control medicine (P is all＜0.05) to gastralgia and the scorching hot curative effect of gastral cavilty, and to the curative effect of gastral cavilty feeling of fullness with contrast medicine similar (P＞0.05).

2, minor symptom curative effect (PP)

Treatment back two groups of patient's traditional Chinese medical science time disease curative effect is shown in table 22:

Table 22 treatment back two groups of loyalty person's traditional Chinese medical science time disease curative effect is (PP) relatively

Doctor's symptom	Group	Unusual routine number	The symptom curative effect				Cure-remarkable-effectiveness rate (%)	Total effective rate (%)	Hc	P
											Face more	Produce effects	Effectively	Invalid
			Gastral cavity is noisy, and to have the slow-witted food of the tired power in the place of deciding to do less bitter taste just dry and hard	Treatment group treatment of control group group treatment of control group group treatment of control group group treatment of control group group treatment of control group group control group	288 93 286 94 288 96 289 93 297 97 249 86	179 49 235 60 114 26 134 36 188 54 163 49									24 10 1 0 25 8 33 12 35 8 38 4	55 18 0 1 93 41 94 25 54 23 41 27	30 16 50 33 56 21 28 20 20 12 7 6	70.49 63.44 82.52 63.83 48.26 35.42 57.79 51.61 75.08 63.92 80.72 61. 63	89.58 82.80 82.52 64.89 80.56 78.13 90.31 78.49 93.27 87.63 97.19 93.02	3.0490 13.5560 3.7713 3.5254 3.1658 4.8822	0.0808 0.0002 0.0521 0.0604 0.0752 0.0271

Treatment back each traditional Chinese medical science minor symptom curative effect of two groups of chronic atrophic gastritis patients relatively, through rank test, show that the treatment group is better than matched group (P is all＜0.05) to the curative effect of localized pain, constipation with dry stool, and two groups of curative effects to upset in the stomach, spiritlessness and weakness, indigestion and loss of appetite lack of appetite and dry mouth with bitter taste similar (P all＞0.05).

Medicine of the present invention to the cure-remarkable-effectiveness rate and the total effective rate of the minor symptom of chronic atrophic gastritis (deficiency of both QI and YIN hold concurrently knot card in the stagnant heat) is respectively: upset in the stomach 70.49%, 89.58%, localized pain 82.52%, 82.52%, spiritlessness and weakness 48.26%, 80.56%, indigestion and loss of appetite lack of appetite 57.79%, 90.31%, dry mouth with bitter taste 75.08%, 93.27% and constipation with dry stool 80.72%, 97.19%.Compare with matched group, show that the treatment group is better than matched group (P is all＜0.05) to the curative effect of localized pain, constipation with dry stool, and two groups of curative effects to upset in the stomach, spiritlessness and weakness, indigestion and loss of appetite lack of appetite and dry mouth with bitter taste similar (P all＞0.05).

(5) picture of the tongue, pulse condition curative effect

Two groups of patient's tongues, pulse condition curative effect are shown in table 23:

Table 23 liang group patient picture of the tongue, pulse condition curative effect are relatively

Tongue, pulse condition	Group	Treat front/rear picture of the tongue, pulse condition				Normalization rate (%)	P In the group	P Between group
									(-)/ (-)	(-)/ (+)	(+)/ (-)	(+)/ (+)
		The picture of the tongue pulse condition	Treatment group (318 example) matched group (105 example) treatment group (318 example) matched group (105 example)	3 0 24 3	1 0 1 1								165 51 159 52	149 54 134 49	52.55 48.57 54.27 51.49	0.0000 0.0000 0.0000 0.0000	0.6074 0.2865

Treat forward and backward picture of the tongue, pulse condition curative effect relatively for two groups, through pairing design X 2 test, two groups of P all＜0.05, difference has statistical significance, illustrates that two groups of unusual picture of the tongue, pulse conditions to chronic atrophic gastritis (deficiency of both QI and YIN hold concurrently stagnant heat in knot card) patient all have significant curative effect.

Two groups tongue, pulse condition curative effect be through the contingency table X 2 test, and P is all greater than 0.05, and the difference not statistically significant illustrates that two groups chronic atrophic gastritis (deficiency of both QI and YIN hold concurrently stagnant heat in knot card) patient's picture of the tongue, pulse condition curative effect is similar.

By to the forward and backward patient's of medication tongue, the analysis of pulse condition, show the gastritis unusual picture of the tongue of granule to chronic atrophic gastritis (deficiency of both QI and YIN hold concurrently stagnant heat in knot card) patient that disappear: light red tongue is fat tender or tooth seal, white and thin fur arranged; Or dimly red tongue or purple dark, or ecchymosis is arranged; Or red tongue with yellow fur; Red tongue with a little fluid, the few and pulse condition of tongue: thready pulse or deep-thready pulse, or stringy and rapid pulse or string are puckery, and (P＜0.05) all is significantly improved.Compare difference not statistically significant (P＞0.05) with matched group.

(7) helicobacter pylori curative effect

Two groups to treat forward and backward helicobacter pylori check result more shown in table 24:

The forward and backward two groups of patient's helicobacter pylori check results of table 24 treatment relatively

Group	Treat front/rear helicobacter pylori check result				Clearance rate (%)	P In the group
							(-)/(-)	(-)/(+)	(+)/(-)	(+)/(+)
	Treatment group (312 example) matched group (102 example)	115 39	4 0	96 14							97 49	49.74 22.22	0.0000 0.0005

By table 24 as seen, treat forward and backward helicobacter pylori inspection relatively for two groups, through pairing design X 2 test, P all＜0.05, difference has statistical significance, and two groups of effects that helicobacter pylori had remarkable removing are described.

Treat forward and backward helicobacter pylori check result through the contingency table X 2 test for two groups, card side=16.0130, df=3, showing horizontal p=0.0011, P＜0.05, difference has statistical significance, in conjunction with curative effect rate explanation treatment group group chronic atrophic gastritis patient helicobacter pylori is removed curative effect and is better than matched group.

By comparing to treating forward and backward helicobacter pylori check result, show that two groups all have the effect (P all＜0.05) of remarkable removing to chronic atrophic gastritis (deficiency of both QI and YIN hold concurrently knot card in the stagnant heat) patient's helicobacter pylori, the clearance rate of treatment group is 49.74%, the matched group clearance rate is 22.22%.Two groups relatively, illustrates that treatment group group is better than matched group (P＜0.05) to chronic atrophic gastritis patient helicobacter pylori removing curative effect

Six, the multicenter curative effect relatively

Demonstrate,prove curative effect, gastroscopy effect and pathology curative effect relatively between Drug therapy chronic atrophic gastritis of the present invention (deficiency of both QI and YIN hold concurrently knot card in the stagnant heat) the III clinical trial phase multicenter, credit is analysed by statistics, difference not statistically significant (P＞0.05) illustrates that each center curative effect is similar.

Seven, safety evaluatio

In the III clinical trial phase process, serious adverse events does not take place, for 1 grade of reagent thing safety evaluatio.

The III clinical trial phase is observed conclusion: adopt multicenter, at random, double blinding and show traditional Chinese medicine composition for treating chronic atrophic gastritis of the present invention (deficiency of both QI and YIN hold concurrently stagnant heat in knot card) determined curative effect with the III clinical trial phase result of positive drug parallel control, and general curative effect is better than the positive control medicine, do not see the toxic and side effects and the adverse events of drug-induced in the clinical trial, confirm that further Chinese medicine composition of the present invention is the safe and effective medicine of treatment chronic atrophic gastritis (deficiency of both QI and YIN hold concurrently knot card in the stagnant heat).

Claims (10)

1. a Chinese medicine composition for the treatment of chronic gastritis, chronic atrophic gastritis and the canceration in early stage of prevention stomach is characterized in that being made by following bulk drugs: Radix Pseudostellariae 90-110 part, Herba Dendrobii 40-60 part, Radix Notoginseng 4-6 part, Rhizoma Curcumae 30-50 part, Radix Curcumae 30-50 part, Radix Paeoniae Alba 30-50 part, Herba Hedyotidis Diffusae 56.67-76.67 part, Herba Taraxaci 73.33-93.33 part, Herba Scutellariae Barbatae 40-60 part, Radix Glycyrrhizae 10-30 part.

2. according to the Chinese medicine composition of claim 1, it is characterized in that the weight portion of each crude drug is: 100 parts of Radix Pseudostellariaes, 50 parts of Herba Dendrobiis, 5 parts of Radix Notoginseng, 40 parts of Rhizoma Curcumae, 40 parts of Radix Curcumaes, 40 parts of the Radix Paeoniae Albas, 66.67 parts of Herba Hedyotidis Diffusaes, 83.33 parts of Herba Taraxacis, 50 parts of Herba Scutellariae Barbataes, 20 parts in Radix Glycyrrhizae.

3. according to the Chinese medicine composition of claim 1, it is characterized in that being prepared into any oral formulations according to Chinese medicine conventional formulation method.

4. according to the Chinese medicine composition of claim 3, it is characterized in that described oral formulations is pill, capsule, tablet, powder, granule or oral liquid.

5. according to the Chinese medicine composition of claim 4, it is characterized in that described oral formulations is a granule.

6. method for preparing the Chinese medicine composition of claim 1 may further comprise the steps:

(1) takes by weighing each raw material by following weight portion: Radix Pseudostellariae 90-110 part, Herba Dendrobii 40-60 part, Radix Notoginseng 4-6 part, Rhizoma Curcumae 30-50 part, Radix Curcumae 30-50 part, Radix Paeoniae Alba 30-50 part, Herba Hedyotidis Diffusae 56.67-76.67 part, Herba Taraxaci 73.33-93.33 part, Herba Scutellariae Barbatae 40-60 part, Radix Glycyrrhizae 10-30 part;

(2) get Rhizoma Curcumae, Radix Curcumae and extract volatile oil after, medicinal residues decoct with water, decoction liquor is centrifugal, gets supernatant, extracting solution A;

(3) get Radix Pseudostellariae, Herba Dendrobii, the Radix Paeoniae Alba, Herba Hedyotidis Diffusae, Herba Taraxaci, Herba Scutellariae Barbatae, Radix Glycyrrhizae and decoct with water, collecting decoction, filtration, extracting solution B;

(4) Radix Notoginseng is used alcohol reflux, extracting solution filters, and reclaims ethanol, gets extracting solution C;

(5) merge said extracted liquid A, B, C, concentrating under reduced pressure, centrifugal, get supernatant, get extracting solution D;

(6) get Rhizoma Curcumae, Radix Curcumae volatile oil, add among the extracting solution D, get the pharmaceutical preparation intermediate, make finished product through preparations shaping technology again; Perhaps the dry extract that makes after drying of extracting solution D is made the preparation intermediate again, adds Rhizoma Curcumae, Radix Curcumae volatile oil, mixing, and drying is made finished product through preparations shaping technology.

7. according to the method for claim 6, it is characterized in that in the step (2) that medicinal residues with Rhizoma Curcumae and Radix Curcumae add 8～15 times of weight decoctings and boiled 1～3 hour.

8. according to the method for claim 6, it is characterized in that in the step (3) Radix Pseudostellariae, Herba Dendrobii, the Radix Paeoniae Alba, Herba Hedyotidis Diffusae, Herba Taraxaci, Herba Scutellariae Barbatae, Radix Glycyrrhizae being decocted with water twice, for the first time add 8～15 times of weight decoctings and boiled 1～3 hour, add 8～15 times of weight decoctings 1～3 hour for the second time.

9. according to the method for claim 6, it is characterized in that in the step (4) Radix Notoginseng with 50%～90% alcohol reflux 2～3 times; For the first time 4～8 times of weight 50%～90% ethanol extractions are 1～3 hour, and 4～8 times of weight 50%～90% ethanol extractions are 1～3 hour for the second time, and 4～8 times of weight 50%～90% ethanol extractions are 1～3 hour for the third time.

10. the Chinese medicine composition of claim 1 is preparing the purposes for the treatment of in chronic gastritis, chronic atrophic gastritis and prevention stomach canceration in the early stage medicine.