CN103251848A - Pharmaceutical composition for preventing and treating gastric cancer and precursor lesion of gastric cancer - Google Patents

Abstract

The invention discloses a pharmaceutical composition for preventing and treating gastric cancer and precursor lesion of gastric cancer. The composition comprises the main effective components of river deer milk, Codonopsis pilosula, Rhizoma Atractylodis Macrocephalae, Poria cocos, semen coicis, Chinese yam and tangerine pith. The composition integrates functions of several effective components of traditional Chinese medicines which have the synergetic and supplementary effect, and has good effect for improving the function of the digestive system and preventing and treating gastric cancer and precursor lesion of gastric cancer.

Description

A kind of be used to the pharmaceutical composition of preventing and treating gastric cancer and cercinoma prophase pathologic change thereof

Technical field

The invention belongs to compound Chinese medicinal preparation and field of health care products, is to be the pharmaceutical composition that is used for improving digestive system function and prevention, treatment gastric cancer and cercinoma prophase pathologic change thereof of feedstock production with Chinese medicine.

Background technology

Various chronic gastritiss, gastric and duodenal ulcers are common frequently-occurring diseases, and according to investigations, that suffers from chronic gastritis more than 50 years old reaches 50% and the gastric and duodenal ulcers disease has 10% people to suffer from this disease in life at it, and easily recurrence, can cancerate in the course of time.Gastric cancer is one of common malignancy, and its sickness rate and mortality rate all occupy the prostatitis of malignant tumor in China.The canceration of gastric epithelial cell is a progressive process, and in the normal experience lasting preventing precancerous lesion of stomach cancer stage for many years, some patient finally can be developed into gastric cancer.Therefore prevent or the treatment gastric precancerous lesion, stoping precancerous lesion to be converted into pernicious gastric cancer is an important channel that prevents and treats gastric cancer, and China's cancer morbidity and patient death rate are significant for reducing.How with this type of gastroenteropathy of western medicine, lay particular emphasis on the gastrointestinal local patholoic change at present, the globality of the body of having slipped, and drug price costliness, toxic and side effects is big, the relapse rate height.

The inventor is through research with keen determination; especially pass through the research of river deer treasured to the therapeutical effect of gastric precancerous lesion and treatment mechanism; can protect the effect of gastric mucosa function and control gastric precancerous lesion and then the generation of prevention gastric cancer well based on the river deer treasured; the invigorating the spleen and benefiting QI of comprehensive Radix Codonopsis, the Rhizoma Atractylodis Macrocephalae, Poria, Semen Coicis, Rhizoma Dioscoreae, vascular aurantii again; improve the Chinese medicine composition of gastrointestinal function, for gastrotherapy and Prevention and Treatment of Stomach Cancer provide new therapeutic scheme.

Summary of the invention

The invention provides a kind of be used to the pharmaceutical composition that improves digestive system function and prevention, treatment gastric cancer and cercinoma prophase pathologic change thereof.

This pharmaceutical composition is under the guidance of theory of Chinese medical science, optimizes and selects that Chinese medicine formula obtains, and each component comprehensively plays a role, and has good curing and preventive effect for above-mentioned disease.

Pharmaceutical composition of the present invention is made by following raw materials in weight portion: the precious 20-35 part of river deer, peeling Radix Codonopsis 6-10 part, peeling Rhizoma Atractylodis Macrocephalae 5-10 part, peeling Poria 8-12 part, peeling Rhizoma Dioscoreae 8-12 part, Semen Coicis 8-12 part, vascular aurantii 2-5 part, compound vitamin B 0.5-1 part, vitamin D 0.5-1 part, calcium 0.5-1 part, ferrum 0.5-1 part, zinc 0.5-1 part, Fructus Hordei Germinatus lactose 15-20 part, starch 10-15 part.With said components drying, pulverizing, grind the back altogether and crossed 200 mesh sieves, make granule or make tablet or optionally be prepared into clinical other dosage form commonly used with conventional method.

Each composition all has the effect of certain strengthening the spleen and nourishing the stomach in the compositions of the present invention, wherein:

River deer treasured: invigorating the spleen and replenishing QI, building body, food stagnation removing appetizing;

Radix Codonopsis: gas in replenishing QI to invigorate the spleen, the lung moistening and production of body fluid promoting, the strong fortune;

The Rhizoma Atractylodis Macrocephalae: spleen invigorating helps in fortune, the removing dampness freely, stomach function regulating helps digestion;

Poria: burnt in spleen invigorating eliminating dampness by diuresis, the fortuneization, stomach function regulating helps digestion;

Semen Coicis: spleen benefiting and stimulating the appetite, transmitting and distributing the fluids, clear middle cuticula;

Rhizoma Dioscoreae: spleen invigorating helps fortune, stomach reinforcing tonify deficiency, holds concurrently and transfer the lung kidney;

Vascular aurantii: fragrant is amusing, circulation of qi promoting is whetted the appetite, help digestion smooth in;

The Fructus Hordei Germinatus lactose: the strengthening the spleen to promote digestion stomach reinforcing also increases sweet taste, is in harmonious proportion all product;

Vitamin B, D and calcium, ferrum, zinc etc.: vitimin supplement and trace element are conducive to help gastrointestinal function recovery and building body etc.

Starch: excipient and filler.

Above-mentioned active component is combined through special ratios, plays invigorating spleen and reinforcing stomach, the comprehensive function of building body.

The consumption of raw material components of the present invention is also groped to sum up to draw through the inventor in a large number, and each amounts of components all has better curative effect in the following portions by weight scope.

The invention provides pharmaceutical composition, made by the raw material of following weight portion:

Preferably made by the raw material of following weight portion:

Can add various conventional adjuvant required when preparing different dosage form in the pharmaceutical composition of the present invention, be prepared into any peroral dosage form commonly used as disintegrating agent, lubricant, binding agent etc. with the method for Chinese medicinal of routine, as granule, pill, powder, tablet, capsule, oral liquid etc.

The specific embodiment

Effective ingredient river deer treasured among the present invention can adopt method well known in the art to obtain, for example raise and train the above newborn river deer of breeding three generations and sucking river deer milk back stomach, especially form Off-white solid or semi-solid block in abomasum (glandular stomach) meeting, underwent operative is drying to obtain after taking out.

Particularly: 1. select the above newborn river deer of breeding three generations of raising and train of 12 ages in days to raise with river deer breast bottlefeeding.After three hours, lump can be touched in this breast river deer glandular stomach position;

2. newborn river deer is anaesthetized sterilization, bring aseptic operating room into, be fixed in operating-table, carry out live body and perform the operation, cut glandular stomach open, take out Off-white solid or semi-solid block, dry, pulverizing, namely obtaining can be for the river deer treasured of the present invention's use.

Certainly, the present invention also can adopt the precious raw material medicine of commercially available river deer, and the river deer treasured of the concrete employing of following examples institute is the commercially available prod.

Embodiment 1:

Take by weighing each raw material by following parts by weight: river deer treasured 25, peeling Radix Codonopsis 8, the peeling Rhizoma Atractylodis Macrocephalae 6, peeling Poria 10, Semen Coicis 10, peeling Rhizoma Dioscoreae 10, vascular aurantii 4, compound vitamin B 0.5, vitamin D 0.5, calcium 0.5, ferrum 0.5, zinc 0.5, Fructus Hordei Germinatus lactose 15; Drying, pulverizing, mixing, and with 15 parts of figurations of starch, filling, grind superfine end altogether, cross 200 mesh sieves, make granule altogether, be pressed into tablet, hereinafter referred to as the precious tabellae stomachicus of river deer, every middle river deer treasured content is amounted to 30 milligrams.

Below further set forth the beneficial effect of pharmaceutical composition of the present invention by testing example, test the routine clinical research effect that has comprised pathological changes before the present composition is for reversing stomach.

Test example 1:

Year March in March, 2010 to 2013, the outpatient service of my the spleen-stomach disease section of institute is according to the tentative suggestion of digestive endoscopy branch of Chinese Medical Association chronic gastritis endoscopic classification grade scale in 2003 and treatment, through pathological diagnosis be chronic atrophic gastritis (CAG) companion mucosa intestinal epithelial metaplasia (Im) and (or) dysplasia (Dys) patient 200 examples, man's 116 examples, woman's 84 examples, age 25-83 year.Be divided into treatment at random and organize 100 examples (male 53 examples, women 47 examples), matched group 100 examples (male 63 examples, women 37 examples).Positive 148 examples of helicobacter pylori (Hp) wherein, negative 52 examples of Hp.Merge bile reflux 38 examples, gastric cancer family history 32 examples are arranged.Aspect comparing differences such as two groups of ages, sex, severity extent do not have significance (P＞0.05).

Exclusion standard: 1, with other gastrointestinal tract disease patients, as malignant tumor of digestive tract, peptic ulcer etc.; 2, with the systemic disease person, as severe cardiac liver renal failure, diabetes, autoimmune disease etc.; 3, gestation or women breast-feeding their children; 4, allergic constitution or to this test medication allergy sufferers; 5, further consultation or the person of following up a case by regular visits on schedule.

One, Therapeutic Method

The precious tabellae stomachicus of river deer of oral embodiment 1,2 slices/time, every day 3 times are organized in treatment.Matched group is taken WEIFUCHUN PIAN (being produced by Hu Qingyu Pharmaceutical Workshop, Hangzhou pharmaceutical factory), 4 slices/time, every day 3 times.Two groups was a course for the treatment of with 3 months all, serve on 2 courses for the treatment of.Withdraw the medicine that all influence this research during the treatment.

Two, detect index

Clinical symptoms (upper abdominal pain, abdominal distention, acid regurgitation, belch, poor appetite, nausea and vomiting) before and after the selected patient is marked; Going gastroscopy and pathological biopsy, Hp before and after the treatment respectively checks.

Three, curative effect judging standard

(1) clinical efficacy diagnostic criteria

Cure: clinical symptom disappearance or basic the disappearance;

Produce effects: clinical symptoms is obviously improved;

Effectively: clinical symptoms makes moderate progress;

Invalid: clinical symptoms is not improved or is increased the weight of.

Total effective rate=(healing+produce effects+effectively)/total routine number * 100%.

(2) gastroscope, pathological diagnosis standard

The gastric mucosal lesions degree evaluation is as follows with reference to the whole nation, digestive endoscopy branch of Chinese Medical Association Dalian in 2003 chronic gastritis thematic classification standard under the gastroscope:

The classification of chronic gastritis endoscopic classification

The evaluation criteria that changes the gastric mucosa pathological tissue adopts the standard in the national chronic gastritis meeting in 2000.

(3) anti-Hp curative effect diagnostic criteria

The Hp positive: the RUT experiment is positive;

The Hp feminine gender: the RUT experiment is negative.

Four, statistical procedures

Adopt the SPSS11.5 statistical software to carry out statistical disposition, enumeration data relatively adopts X ²Check.

Five, result

(1) two group of clinical efficacy relatively

Two groups for the treatment of back clinical efficacies compare, and difference has significance (X ²=9.072, P＜0.05).See the following form.

The two groups of patients clinical curative effects in treatment back are (example) relatively

(2) two groups of gastroscopes, pathology curative effects compare

Treatment group gastroscope result shows total effective 83 examples, invalid 17 examples, and total effective rate 83.00%, matched group are respectively 66 examples, 34 examples, and 66.00%, two group of comparing difference of total effective rate has significance (X ²=7.606, P＜0.05); Treatment group pathology (CAG, Im, Dys) result shows that total effectively number is respectively 80,72 and 31 examples, invalid number is respectively 20,10 and 4 examples, total effective rate is respectively 80.00%, 87.80%, 88.57%, matched group pathology (CAG, Im, Dys) result shows that total effectively number is respectively 64,49 and 18 examples, invalid number is respectively 36,20,10 examples, its total effective rate is respectively 64.00%, 71.01% and 64.29%, two group of comparing difference statistical significance (X ²=5.308-6.349, P＜0.05).

(3) anti-Hp curative effect relatively

After 2 course of therapy, positive 59 examples for the treatment of group Hp, negative 24 examples, matched group is respectively 58,7 examples, and two groups of comparing differences have significance (X ²=7.249, P＜0.05)

Conclusion

The precious tabellae stomachicus of river deer can significantly improve patient's CAG clinical symptoms, and gastroscope, pathology and Hp assay obviously are better than matched group, and therefore compositions of the present invention is the active drug of present gastric precancerous lesion patient reversal therapies.

Claims (3)

1. One kind the prevention or the treatment gastric precancerous lesion pharmaceutical composition, made by the raw material of following weight portion:

   
2. 2. pharmaceutical composition according to claim 1, made by the raw material of following weight portion:

   

   
3. 3. pharmaceutical composition according to claim 1 and 2, it is prepared to granule, pill, powder, tablet, capsule or oral liquid.