CN102755418A - Medicinal composition for treating precancerous lesions of chronic atrophic gastritis and preparation method thereof - Google Patents
Medicinal composition for treating precancerous lesions of chronic atrophic gastritis and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a medicinal composition for treating precancerous lesions of chronic atrophic gastritis and a preparation method thereof. The composition consists of the following bulk pharmaceuticals in parts by weight: 10-20 parts of orange immature fruit, 15-30 parts of barbed skullcap herb, 10-15 parts of polygonum cillinerve (nakai) ohwi and 10-20 parts of heterophylly falsestarwort root. The preparation method comprises the following steps of: drying one tenth to three fifth of polygonum cillinerve (nakai) ohwi at a low temperature, and smashing into fine powder of 100-200 meshes to obtain I for later use; adding water into the remaining polygonum cillinerve (nakai) ohwi, orange immature fruit, barbed skullcap herb and heterophylly falsestarwort root in an amount of 6-10 times the total amount of the remaining polygonum cillinerve (nakai) ohwi, orange immature fruit, barbed skullcap herb and heterophylly falsestarwort root for decocting and extracting for 2-4 times, every time for 0.5-2 hours, filtering, combining filtrates, and concentrating under reduced pressure till the relative density is 1.30-1.35 at 50 DEG C to obtain II for later use; and mixing I and II fully and uniformly, drying at a low temperature under reduced pressure, adding conventional auxiliary materials, and preparing into powder, tablets, particles, hard capsules and pills according to the conventional process. As proved by clinical observational research, the medicinal composition has the effect of treating precancerous lesions of chronic atrophic gastritis.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition of treating precancerous lesions of chronic atrophic gastritis and preparation method thereof, belong to field of traditional Chinese medicine pharmacy.
Background technology
Gastric cancer is still the important cause of the death of whole world malignant tumor so far, also is the malignant tumor that the present M & M of China all ranks first.Numerous research datas show; Carninomatosis becomes (Precancerous lesions of gastric cancer gastric mucosal cell often experienced stomach before the canceration cell before; PLGC) evolving stage; The pathological change in this stage is intestinal metaplasia in gastric mucosa and dysplasia, and research confirms that it is the pathologic basis of intestinal-type gastric cancer morbidity.It is generally acknowledged that the above dysplasia of moderate belongs to the cercinoma prophase pathologic change of gastric cancer, this type of patient is many with intestinal epithelial metaplasia.The foreign literature report, particularly with intestinal epithelial metaplasia and/or dysplasia person, the incidence rate of gastric cancer can be up to 9-10% for chronic atrophic gastritis (CAG).Therefore, discerning and control PLGC early is the important channel that prevents and treats gastric cancer to the development of the aspect of gastric cancer.In the end of the year 1991, State Planning Commission and State Administration of Traditional Chinese Medicine classify gastric precancerous lesion as one of special topic for tackling key problems of eight or five Chinese medicine prevention major disease researchs, have reflected the attention of country to this case study.
Research to PLGC is the most active field of domestic and international gastric cancer study on prevention at present.But external research does not still have breakthrough; The tracing study of PLGC is still the major measure of prevention; Treatment then is primarily aimed at precancerous condition such as the chronic atrophic gastritis of gastric cancer etc. to be carried out, in case when with severe dysplasia the canceration trend being arranged, then consider the row surgical operation.Necessarily prevent prevention and reverse preventive and therapeutic effect although the recent research retinoid induces differentiation agent that P of Rats LGC is developed to have to gastric cancer; But still rest on animal experiment stage and do not use it clinical, selenium yeast and folic acid to people's gastric mucosaization give birth to, the reversal therapies effect of dysplasia still under study for action.Chinese medicine PLGC has significant curative effect advantage, and increasing in recent years research shows that Chinese medicine preparation is significant to the curative effect of PLGC reverse property treatment.Comprehensive domestic and foreign literature report, total effective rate are more than 90%, and gastroscope and pathology curative effect are about 60-70%, and intestinal epithelial metaplasia and atrophic lesion antidromicity all can occur and take a turn for the better the bright prospects of having showed the Chinese medicine primary disease.
The generation of CAG and helicobacter pylori (HP) infect relevant, and HP is that to have a poison of damp and hot characteristic evil, invades the stomach internal organs, and indigestion hinders spleen, gastric qi stagnate then and fall not normal, glutted, the belch of upper abdomen; The stagnant then transformation failure of spleen of temper, distension, poor appetite, inappetence; The stagnation of QI is blood stasis then, goes into network with the evil bridle for a long time of seasonal noxious pathogen, coagulates mutually with blood, and the malicious stasis of blood is handed over resistance, and gastral cavilty is pain repeatedly.QI and blood poison stasis of blood indigestion network, stagnating is knot, the active proliferation of gastric mucosa intestinal gland metaplasia for a long time.Combining and returning pathogenesis is stagnation of QI poison knot, and the stomach network is become estranged.Poison is the cause of disease, and its stagnation of QI, to coagulate the stasis of blood be the pathomechanism that forms under the evil condition of HP poison infecting.Depression and stagnation of QI, the malicious stasis of blood knot mutually are to cause the damage of stomach network, the basic reason of hamartoplasia.Promoting QI to circulate and dispersing the agglomeration of the pathogens, eliminating toxic substances to remove stasis are worked as in the treatment legislation.
Summary of the invention
The object of the invention is to provide a kind of pharmaceutical composition of treating precancerous lesions of chronic atrophic gastritis and preparation method thereof.
The present invention seeks to realize through following technical scheme.
The crude drug of medicinal substances compositions of the present invention consists of:
Fructus Ponciri Trifoliatae (Fructus Ponciri Trifoliatae Immaturus) 10～20 weight portions, Herba Scutellariae Barbatae 15～30 weight portions, Antenoron filiforme herb 10～15 weight portions, Radix Pseudostellariae 10～20 weight portions.
The crude drug composition of medicinal substances compositions of the present invention is preferably:
Fructus Ponciri Trifoliatae (Fructus Ponciri Trifoliatae Immaturus) 14 weight portions, Herba Scutellariae Barbatae 16 weight portions, Antenoron filiforme herb 10 weight portions, Radix Pseudostellariae 10 weight portions.
The crude drug composition of medicinal substances compositions of the present invention is preferably:
Fructus Ponciri Trifoliatae (Fructus Ponciri Trifoliatae Immaturus) 11 weight portions, Herba Scutellariae Barbatae 28 weight portions, Antenoron filiforme herb 11 weight portions, Radix Pseudostellariae 18 weight portions.
The crude drug composition of medicinal substances compositions of the present invention is preferably:
Fructus Ponciri Trifoliatae (Fructus Ponciri Trifoliatae Immaturus) 13 weight portions, Herba Scutellariae Barbatae 25 weight portions, Antenoron filiforme herb 12 weight portions, Radix Pseudostellariae 15 weight portions.
The crude drug composition of medicinal substances compositions of the present invention is preferably:
Fructus Ponciri Trifoliatae (Fructus Ponciri Trifoliatae Immaturus) 16 weight portions, Herba Scutellariae Barbatae 20 weight portions, Antenoron filiforme herb 13 weight portions, Radix Pseudostellariae 13 weight portions.
The crude drug composition of medicinal substances compositions of the present invention is preferably:
Fructus Ponciri Trifoliatae (Fructus Ponciri Trifoliatae Immaturus) 18 weight portions, Herba Scutellariae Barbatae 15 weight portions, Antenoron filiforme herb 14 weight portions, Radix Pseudostellariae 11 weight portions.
Said Antenoron filiforme herb is that wine is processed Antenoron filiforme herb.With clean or cutting after Antenoron filiforme herb, add a certain amount of wine and stir, promptly get.
Crude drug of the present invention is the Chinese medicine medical material, can on market, buy.Wherein, Fructus Ponciri Trifoliatae (Fructus Ponciri Trifoliatae Immaturus), Antenoron filiforme herb two flavor medicines can't be calibrated standard, and existing specification requirement with the used Fructus Ponciri Trifoliatae (Fructus Ponciri Trifoliatae Immaturus) of the present invention, Antenoron filiforme herb is explained as follows:
One, Fructus Ponciri Trifoliatae (Fructus Ponciri Trifoliatae Immaturus) is the fruit of Rutaceae Poncirus plant trifoliate orange Poncirus trifoliata (L.) Raf..
Ecological environment is often cultivated in the roadside, hedgerow is made on limit, field, flower garden.Be distributed in provinces such as Hebei, Shaanxi, Gansu.All there is cultivation in our province middle part Qin crust mountain area.
Growth characteristics machaka or dungarunga.
Form is described high 5-7 rice, and Herb does not have hair.Branch is many, and is flat slightly.Corner angle are arranged, and the sturdy Spina jujubae of close life stings long 1-7 centimetre, and base portion is flat.The trifoliolate leaf alternate; Lobule papery or nearly keratin, the transparent oil droplet point of tool; Terminal leaflet sheet obovate or ellipse, long 2.5-6 centimetre, wide 1.5-3 centimetre, nose-circle and nick, its wedge shape, adnation lobule ellipticity is avette, base portion deflection, edge tool cognate or nearly full edge; The long 1-3 of petiole centimetre, wing is arranged.Hua Dansheng or paired axil are given birth to, and Chang Xianye is open, and yellow-white has fragrance; Sepal 5, long 5-6 millimeter; Petal 5, long 1.8-3 centimetre, common 20 (or the 8-20) of stamen, filigree separates, varying length; The nearly spheroidal of ovary, close by pubescence.Hesperidium aurantium is spherical and slightly flat, 3-5 centimetre in footpath, and orange-yellow, the tool fine hair has fragrance.The florescence 4-5 month, the fruit phase 9-10 month.
Cultivation or the suitable warm environment of cultivation (cultivation) technology, happiness light, cold-resistant.Suitable moistening and well-drained sand loam cultivation.Seminal propagation is main, and the fruit picking in October is put in the basin, and basin is embedded in dark about half chi in the soil, vexed decayed fruit skin.Spring next year, before sowing, take out, edulcoration dries in the shade, the drill seeding then, about 1 cun of earthing can be emerged after 1 month, and the seedling phase needs often to keep ground moistening, transplants after 2 years.
Processing in production place after the beginning of autumn when fruit with maturation and color when not changeing Huang win, dry, cut off carpopodium, cut away half or shredding is dried in the shade.
Process of preparing Chinese medicine method is soaked into the back section with former medicinal clear water, dries to give birth to and uses.
Two, Antenoron filiforme herb is the tuber of Polygonaceae arsesmart floating and thready pulse knotweed Polygonum cillinerve (Nakai) chwi [P.multiflorum Thunb.var.cillinerve (Nakai) Steward].
Ecological environment is born in hillside, roadside, limes marginis and the stone riprap seam.Be distributed in ground such as northeast, northwest.All there is distribution in the Qinling Mountains and the Bashan Mountain, Fuping, more too in vain.
The perennial climing property draft of growth characteristics.
Form is described rhizome and is expanded block, wooden.Stem is elongated, hollow, tip branch.The leaf alternate; The long 0.5-5 of petiole centimetre, last mask ditch, following mask cement papillae or tool ciliolum; Ochrea is membranous, and brown is close to transparent; The oval shape of blade is oval, and long 6-11 centimetre, wide 3-6 centimetre.The panicle axil is given birth to or give birth on the top; Bennet is obvious; Perianth 5 splits, white or lavender, outside sliver master pulse tool wing; Stamen 8; Stigma 3, peltate.The pyrene prismatic, black purple is by the perianth of the membranous wing that enlarges is wrapped.Summer at florescence.
The cultivation or (cultivation) technology of cultivation
Processing in production place spring, autumn excavate, and remove stem and leaf, and fibrous root is cleaned, and section is dried subsequent use, or faces with preceding wine and process or vinegar system.
Process of preparing Chinese medicine method is got crude drug, removes impurity, cleans, and runs through, and cuts sheet, drying, sieve dedust bits.The decoction pieces character is irregular oblong, square circle or circular piece sheet.Pale brown color in surface or rufous, unevenness, there is muscle arteries and veins point nearly center.Periphery bronzing or brownish black, matter is hard, feeble QI perfume (or spice) and bitter in the mouth.In the storage drying receptacle, put aeration-drying place.
Pharmaceutical composition of the present invention adds conventional adjuvant; According to common process, process powder, tablet, granule, hard capsule, soft capsule, drop pill, pill, honeyed pill, soft extract with bee honey agent, microgranule, slow releasing preparation, controlled release preparation, quick releasing formulation, oral liquid or ejection preparation.
Pharmaceutical composition of the present invention can prepare as follows:
Get 1/10～3/5 Antenoron filiforme herb, cold drying is ground into 100 orders～200 order fine powders, gets I, and is subsequent use; All the other Antenoron filiforme herbs and Fructus Ponciri Trifoliatae (Fructus Ponciri Trifoliatae Immaturus), Herba Scutellariae Barbatae, crown prince participate in 6～10 times of water gagings and fry in shallow oil and carry 2～4 times, and frying in shallow oil the time of carrying is 0.5h～2h, filter, and merging filtrate is evaporated to 50 ℃ of relative densities 1.30～1.35, II, subsequent use; With I, the abundant mixing of II, low-temperature reduced-pressure is dry, adds conventional adjuvant, according to common process, processes powder, tablet, granule, hard capsule, pill.
Pharmaceutical composition of the present invention preferably is prepared as follows method:
Get 1/3 Antenoron filiforme herb, cold drying is ground into 100 order fine powders, gets I, and is subsequent use; All the other Antenoron filiforme herbs and Fructus Ponciri Trifoliatae (Fructus Ponciri Trifoliatae Immaturus), Herba Scutellariae Barbatae, crown prince participate in 8 times of water gagings and fry in shallow oil and carry 3 times, fry in shallow oil the time of carrying to be followed successively by 1.5h, 1h, 0.5h at every turn, filter, and merging filtrate is evaporated to 50 ℃ of relative densities 1.30～1.35, II, subsequent use; With I, the abundant mixing of II, low-temperature reduced-pressure is dry, adds conventional adjuvant, according to common process, processes powder, tablet, granule, hard capsule, pill.
The arduous temperature of monarch drug Fructus Ponciri Trifoliatae (Fructus Ponciri Trifoliatae Immaturus) has the eliminating stagnation of regulating the flow of vital energy effect in the crude drug of the present invention, is longer than and controls gastral cavilty distension pain; " Zhejiang medicinal plants will " carrier has the function of " be good for the stomach and regulate the flow of vital energy, removing obstruction for relieving pain ", " controlling the gastral cavilty distending pain; dyspepsia ", but and treatment of esophagus cancer, " national Chinese herbal medicine compilation " carrier have " invigorating the stomach and promoting digestion; promoting the circulation of QI to relieve pain " effect, cure mainly stomachache.These article are regulated the flow of vital energy, are good at brokenly to loose, and the eliminating stagnation heavily fortified point that disappears effectively, anti-hypertrophy is the QI regulating medicine with antitumaous effect.The ministerial drug Herba Scutellariae Barbatae, hot flat, have " the heat-clearing and toxic substances removing pain relieving, blood circulation promoting and blood stasis dispelling, anticancer " function, be usually used in treating various tumors; The adjuvant drug Antenoron filiforme herb is the local medical herbs of Qin's crust mountain area treatment stomachache, the property bitter cold, and one of its function heat-clearing and toxic substances removing strengthens the ministerial drug antipyretic and antidote functions; Processed with wine has digestion promoting function, its two promoting blood circulation and cooling blood, and dissipation stomach network coagulates the stasis of blood; Stagnation resolvation is with fixed attention loose, and channels is beneficial to the mucosa reparation with smooth." Bashan Mountain, Qinling Mountains natural drug will " records and promotes the ulcer healing effect.The sweet flat little hardship of messenger drug Radix Pseudostellariae, QI invigorating nourishing the stomach, reinforcing both QI and YIN; Be usually used in weakness after being ill, fatigue and weakness and Tianjin are few thirsty, and lid one of which primary disease Chang Jiuyan is not healed; Often injure the temper stomach-Yin, the ability of these article tool QI invigorating nourishing the stomach is for assistant makes it; The monarch-minister drug bitter cold is prone to the moon of feeling frustrated among its two side again, joins Radix Pseudostellariae and takes a tonic or nourishing food to build up one's health gas the moon, prevents monarch-minister drug bitter cold impairment of YIN.Four Chinese medicine thing compatibility is played promoting QI to circulate and dispersing the agglomeration of the pathogens altogether, the merit of eliminating toxic substances to remove stasis, and remarkable analgesic effect is arranged.Its eliminating stagnation is to be used for realizing through dispelling the stagnated QI, and knot looses malicious stagnation resolvation is loose, and knot looses to disappear and hardly gives birth to suppress intestinalization.Detoxifcation can be eliminated the cause of disease (HP infection), and is cold with heat extraction, can improve damp and hot symptoms such as heartburn, bitter taste effectively, and pain relieving is the sign that blood stasisization is loose.Compound compatibility is organized rigorous, and gas, poison, blood are ruled together, and effectiveness is concentrated; Pathogenesis treatment combines with symptom treatment; The treatment of macroscopic view syndrome combines with gastric mucosa microcosmic lesions treatment, has embodied the uniformity of side with disease, so chronic atrophic gastritis companion intestinalization is given birth to; Card belongs to stagnation of QI poison knot, and the person of becoming estranged is evident in efficacy for the stomach network.Have promoting QI to circulate and dispersing the agglomeration of the pathogens, the effect of pathological changes cures mainly chronic atrophic gastritis before the eliminating toxic substances to remove stasis, reversing stomach, accompanies dysplasia or intestinal epithelial metaplasia, and gastral cavilty distension pain is heartburn, acid regurgitation, and belch, xerostomia is waited bitterly for card and is belonged to the double deficiency of both QI and YIN of malicious stasis of blood friendship resistance.
Following experimental example and embodiment are used to further specify but are not limited to the present invention.
The clinical observation of experimental example 1 pharmaceutical composition of the present invention (pressing embodiment 1 preparation) treatment chronic atrophic gastritis gastric precancerous lesion
1. data and method
1.1 clinical data: the patient that selected case all derives from Affiliated Hospital's in February, 2000～2004 year outpatient service in February and is in hospital, totally 107 examples.Be divided into treatment group and matched group at random.57 examples are organized in treatment, male 36 examples, women 21 examples; 28～67 years old age, average 45.2 years old, the course of disease 3～21 years, average 11.1 years; Among the gastric gland body atrophy companion, the incomplete colonization of severe gives birth to 30 examples, moderate dysplasia 19 examples, severe dysplasia 2 examples, in, the incomplete colonization of severe gives birth to companion's moderate dysplasia 6 examples.Matched group 50 examples, male's 27 examples, women's 23 examples, 30～65 years old age, average 46.8 years old, medical history 2～23 years, average 11.5 years; In, the incomplete colonization of severe gives birth to 29 examples, moderate dysplasia 15 examples, severe dysplasia 2 examples, in, the incomplete colonization of severe gives birth to companion's moderate dysplasia 4 examples.Age, sex, the course of disease etc. do not have significance meaning (P＞0.05) through statistical analysis between two groups, have comparability.
1.2 case is included standard in: " chronic atrophic gastritis (CAG) fibergastroscope and pathological diagnosis standard and chronic gastritis combination of Chinese and Western medicine diagnosis, dialectical and criterion of therapeutical effect " that diagnostic criteria is formulated with reference to the diagnostic criteria and the nineteen eighty-two Chongqing meeting of Ministry of Public Health " the clinical research guideline of new Chinese medicine treatment chronic atrophic gastritis " formulation made a definite diagnosis; The poison stasis of blood hands over resistance pattern of syndrome standard to meet the primary symptom gastralgia, and is glutted, noisy, scorching hot, inferior disease bitter taste, and belch, poor appetite, red tongue with yellow fur, the purple dim or stasis of blood of matter, deep pulse possesses 3 persons.Voluntary partner treatment person; Gestation or women breast-feeding their children, or be associated with important organ (after one's own heart, brain, lung, liver, kidney) disease patient eliminating.
1.3 Therapeutic Method: adopt random packet, controlled observation method, treatment group give granule of the present invention (every contains crude drug 2.5g), and be oral, each 4, and every day 3 times; Matched group gives WEIFUCHUN PIAN (specification 0.35g/ sheet), and is oral by Huqingyutang Pharmaceutical Co., Ltd., Hangzhou City (the accurate word Z20040003 of traditional Chinese medicines), and each 4, every day 3 times.All be 1 course of treatment March, observes two courses of treatment altogether, the various medicines of the treatment chronic gastritis precancerous lesion of stopping using during the treatment.
1.4 MAIN OUTCOME MEASURES: (1) clinical symptoms is improved situation.Carry out by " case history account "; Gastralgia before and after the itemized record treatments, distension, belch, scorching hot, noisy, poor appetite, picture of the tongue, pulse condition etc.; Adopt the symptom integral method; By do not have, light, in, weigh 4 grades and count 0,2,4,6 fen respectively, total mark changed situation before and after treatment finished back statistics treatment.(2) gastroscope and pathologic finding.Carry out gastroscopy before the treatment with in the first quarter moon of treatment back, observe the mucosa color and luster, situation such as blood vessel perspective, petechia, erosion, and by the body of gland atrophy degree do not have, gently, in, weight classification.(3) pathology of gastric mucosa biopsy.Inflammatory changes, body of gland atrophy, IM or ATP pathological changes situation are observed in the biopsy of diseased region fixed point biopsy tissue, according to each item lesion degree be divided into nothings, gently, in, weigh 4 grades, treat the front and back statistical.(4) HP detects, and row HP detects before and after the treatment.(5) carry out the three big routines and the heart, liver, kidney safety detection, untoward reaction record in the treatment before and after the treatment.
1.5 statistical method: measurement data is used X with t check, enumeration data
2Check
1.6 efficacy assessment standard: with reference to " Ministry of Health of the People's Republic of China. new Chinese medicine clinical research guideline " work out.Clinical recovery: clinical cardinal symptom, sign disappear, and gastroscope and biological tissue pathologic finding confirm that body of gland atrophy, IM and ATP recover normal or disappearance; Produce effects: clinical symptoms, sign disappear basically, integration reduce 2/3 or more than, gastroscope check and biological tissue pathologic finding confirm that body of gland atrophy, IM and ATP recover normal or alleviate 2 degree.Effectively: cardinal symptom, sign obviously alleviate, integration reduce 1/3 or more than, gastroscope check mucosa infection scope is dwindled more than 1/2, the biological tissue pathologic finding confirms the body of gland atrophy, IM and ATP alleviate.Invalid: as not reach effective standard or deterioration person.
2. result
2.1 clinical efficacy is (seeing table 1) relatively: treatment group total effective rate is 91.23%; The matched group total effective rate is 74.00%, and the treatment group obviously is superior to matched group, and significant difference is arranged.
The clinical symptoms curative effect relatively between table 1PLGC group
Compare * P＜0.05 with matched group
2.2 gastroscope and pathological change be (seeing table 2) relatively: treatment group gastric mucosa body of gland atrophy 57 examples, treatment back atrophy 30 examples, clinical cure 27 examples, cure rate 47.4%; Matched group gastric mucosa atrophy 50 examples, treatment back atrophy 39 examples, clinical cure 11 examples, 22%, two group of cure rate of cure rate relatively has significant difference (P＜0.05).Wherein 6 example companion moderate ATP of 36 routine IM patients, clinical cure 19 examples, cure rate 52.8% are organized in treatment; Among the matched group 33 routine patients, wherein 4 examples are accompanied moderate ATP, clinical cure 6 examples, cure rate 18.2%.Two groups of cure rates relatively have significant difference (P＜0.05).Treatment group ATP27 example wherein among the 6 example companions, severe IM, is cured 17 examples, cure rate 63.0%; Control group A TP21 example wherein among the companion, severe IM4 example, is cured 5 examples, and 23.8%, two group of cure rate of cure rate relatively has significance meaning (P＜0.01).
Gastroscope and histopathology are relatively before and after the table 2 liang group treatment
2.3 main clinic symptoms is improved situation (seeing table 3): the treatment group is being improved stomachache, and flatulence is heartburn; Belch, aspect such as noisy is evident in efficacy, and before the treatment significant difference is arranged relatively; With after the treatment of control group relatively, the treatment group is being improved stomachache, is being superior to matched group aspect heartburn, noisy, and significant difference is arranged; Improving flatulence, aspects such as belch are superior to matched group.
A primary symptom integrated value relatively (is divided X ± S) before and after the treatment of table 3 liang group
Annotate: with * * P＜0.01 relatively before the treatment, with △ P＜0.05 relatively after the treatment of control group
2.4 the curative effect of anti-HP relatively: positive 32 examples of treatment group HP before the treatment, its HP clearance rate 48.5% of treatment back, HP eradication rate 44.7%; Positive 24 examples of matched group HP; Its HP clearance rate 31.5% of treatment back, eradication rate 23.3%.Anti-HP clearance rate is organized in treatment, eradication rate all is superior to matched group, and significant difference is arranged.
2.5 toxic and side effects: finish back check hemogram, urine, stool and the heart, liver, the no abnormal change of renal function in treatment, treatment is organized 3 routine patients and in the week of taking medicine, loose stool occurred, adds norfloxacin and defecate after 3 days and often become a full member.
2.6 follow up a case by regular visits to: the check of after 30 routine patients carry out March more than the produce effects, making an appointment after treatment finishes, wherein in 24 for example about further consultations, stomach discomfort, glutted, accidental stomachache appear in 4 examples, and gastroscope and pathologic finding are chronic atrophic gastritis.
3. conclusion
The clinical efficacy of the preceding pathological changes of granule reversing stomach of the present invention has been observed in this research, and the result shows, effective percentage 91.23%; Clinical cure rate 47.4% to gastric mucosa atrophy; To IM clinical cure rate 52.8%, to ATP cure rate 63.0%, its curative effect has been compared the significance meaning with matched group; And do not find obvious toxic and side effects, show that pharmaceutical composition of the present invention is more satisfactory treatment PLGC Chinese medicine preparation.
Experimental example 2 preparation of pharmaceutical compositions technical studies of the present invention
(1) preparation technology's mentality of designing
Crude drug of the present invention is made up of four flavor Chinese medicines such as Fructus Ponciri Trifoliatae (Fructus Ponciri Trifoliatae Immaturus)s; Its compound preparation composition is comparatively complicated, this research according to Chinese medical theory keep and the prerequisite of decoction same dose and clinical efficacy under, in conjunction with the characteristics of modern interrelated data and Chinese medicine preparation; Preparation of pharmaceutical compositions method of the present invention is designed as follows: 1. continue to use the method that decoction water is put forward; To Fructus Ponciri Trifoliatae (Fructus Ponciri Trifoliatae Immaturus), Herba Scutellariae Barbatae, Antenoron filiforme herb in the prescription, Radix Pseudostellariae adopts water extraction, and extracting solution concentrate drying under cryogenic conditions is processed dry extract.2. the Antenoron filiforme herb to frying in shallow oil behind the need adopts part to beat powder and water is proposed the granulation of concentrate mixing low temp drying and crushing; Because Antenoron filiforme herb contains anthraquinone class composition; Poor heat stability, decocting are carried facile hydrolysis in the process, granulate so part adopts directly to pulverize; Both can guarantee that anthraquinone class composition utilized to greatest extent in the Antenoron filiforme herb, and can keep former decoction to take the crude drug amount again simultaneously and in taking limits, remain unchanged.This method is as above divided processing can make the quality of the pharmaceutical preparations reach effectively stable, and composition is complete, and clinical effectiveness improves.Taking dose dwindles, and method for making is easy, is easy to realize suitability for industrialized production.
(2) experimentation
1. water extraction: for curative effect and the decoction that guarantees preparation is equal to, beat the powder except that the part Antenoron filiforme herb in the prescription, all adopt the extraction conditions of decoction, promptly with water boiling and extraction.
1. water extraction is measured: take by weighing Fructus Ponciri Trifoliatae (Fructus Ponciri Trifoliatae Immaturus), Herba Scutellariae Barbatae, Antenoron filiforme herb, Radix Pseudostellariae mixed powder by embodiment 1 recipe quantity and be broken into 10 order left and right sides coarse powder; With the tap water be solvent, according to " Chinese pharmacopoeia appendix XA of version in 2000 " algoscopy of extractum " down " hot dipping " carry out, the result shows that its leaching rate is 12 ± 0.4%.
2. extraction time and number of times: the condition that combines decoction to fry in shallow oil to carry and the character of prescription Chinese medicine; Through multiple extraction test and middle trial production; The result shows that the solvent dosage is 8 times, and frying in shallow oil and carrying number of times is 3 times, and extraction time is followed successively by 1.5h, 1h, 0.5h; Its relative extraction ratio is all more than 90.5%, so the preferable condition that the said extracted condition is carried as water.
2. pulverize: Antenoron filiforme herb is the tuber of Palggonum ciliinerve (Nakai) Qhwi of polygonaceae plant floating and thready pulse knotweed in the prescription.Antenoron filiforme herb contains anthraquinones (chrysophanol, emodin, chrysophanic acid, physcione etc.), wine plant glycoside and Radix Aristolochiae Kaempferi methanol, the second element has multiple biological activity; For making the active ingredient basically identical of itself and decoction; Make the crude drug amount of taking of drug combination preparation of the present invention consistent simultaneously, adopt Antenoron filiforme herb partly to be ground into fine powder with decoction.
1. the mensuration of chrysophanol, emodin in the Antenoron filiforme herb: according to " Chinese pharmacopoeia version in 2000 one " Radix Et Rhizoma Rhei " is carried out to " assay " method down; Through the medical material of three batches of separate sources is measured; Its total amount that contains emodin and chrysophanol is all more than 0.40%, and method is reliable, stable.
2. crushing quantity: (fry in shallow oil twice, whenever fried in shallow oil 30 minutes with the decoction decocting method.Antenoron filiforme herb is fried in shallow oil for the first time under the back and was fried in shallow oil 15 minutes); By " " Radix Et Rhizoma Rhei " item of Chinese pharmacopoeia version in 2000 " assay " method down carries out; Take limits 300g, 250g, 200g, 150g, 100g, 50g with capsule, crushing quantity is pressed embodiment 1 prepared, measures the total amount of chrysophanol, emodin; It is basic identical that the result shows that 150g crushing quantity and decoction contain the total amount of chrysophanol, emodin, so the optimal dose of pulverizing as Antenoron filiforme herb with 150g.
(3) technology explanatory notes
1. the fineness of the pulverizing of Antenoron filiforme herb must be more than 100 orders, to guarantee its bioavailability.For crushing process being easy to carry out stable with the thermal sensitivity biological activity, carry out cold drying before the pulverizing.
2. must to concentrate concentration at the water extract be that 1.30～1.35 (50 ℃) back adds to the Antenoron filiforme herb fine powder, and drying and crushing both had been beneficial to the drying of water extract, guaranteed Antenoron filiforme herb fine powder and water extract mix homogeneously simultaneously.
3. owing to the heat time heating time of preparation dry extract is longer; In order to prevent thermal sensitivity active ingredient failure loss; In the concentrate drying process, should control the heated time and the heating temperature of medicine especially, adopt the concentrate under reduced pressure at low temperature method so concentrate, drying should adopt the vacuum dehydrating at lower temperature method.
The specific embodiment
Following embodiment all can realize the said effect of above-mentioned experimental example.
Embodiment 1 hard capsule of the present invention
[prescription] Fructus Ponciri Trifoliatae (Fructus Ponciri Trifoliatae Immaturus) 700g Herba Scutellariae Barbatae 800g Antenoron filiforme herb (wine is processed) 500g Radix Pseudostellariae 500g
[method for making] got Antenoron filiforme herb 160g, and cold drying is ground into 100 order fine powders, gets I, and be subsequent use.All the other Antenoron filiforme herbs and Fructus Ponciri Trifoliatae (Fructus Ponciri Trifoliatae Immaturus), Herba Scutellariae Barbatae, crown prince participate in 8 times of water gagings and fry in shallow oil and carry 3 times, fry in shallow oil the time of carrying to be followed successively by 1.5h, 1h, 0.5h at every turn, filter, and merging filtrate is evaporated to relative density 1.30～1.35 (50 ℃), II, subsequent use.With I, the abundant mixing of II, low-temperature reduced-pressure is dry, is ground into 80 order fine powders, adds debita spissitudo (85%) alcohol granulation with 20 mesh sieves, cold drying, and granulate is loaded in No. 0 hard capsule case, makes 0.4g/ * 1000 altogether, packs promptly to get.Every contains crude drug 2.5g.Oral, each 4, every day 3 times.
Embodiment 2 granules of the present invention
[prescription] Fructus Ponciri Trifoliatae (Fructus Ponciri Trifoliatae Immaturus) 1100g, Herba Scutellariae Barbatae 2800g, Antenoron filiforme herb (wine is processed) 1100g, Radix Pseudostellariae 1800g.
[method for making] got Antenoron filiforme herb 400g, and cold drying is ground into 200 order fine powders, gets I, and be subsequent use.All the other Antenoron filiforme herbs and Fructus Ponciri Trifoliatae (Fructus Ponciri Trifoliatae Immaturus), Herba Scutellariae Barbatae, crown prince participate in 10 times of water gagings and fry in shallow oil and carry 2 times, and fry in shallow oil the time of carrying is 1h at every turn, filter, and merging filtrate is evaporated to relative density 1.30～1.35 (50 ℃), II, subsequent use.With I, the abundant mixing of II, low-temperature reduced-pressure is dry, is ground into 80 order fine powders, adds debita spissitudo (85%) alcohol granulation with 20 mesh sieves, cold drying, and granulate, packing promptly gets.
Embodiment 3 tablets of the present invention
[prescription] Fructus Ponciri Trifoliatae (Fructus Ponciri Trifoliatae Immaturus) 1300g, Herba Scutellariae Barbatae 2500g, Antenoron filiforme herb 1200g, Radix Pseudostellariae 1500g.
[method for making] got Antenoron filiforme herb 600g, and cold drying is ground into 200 order fine powders, gets I, and be subsequent use.All the other Antenoron filiforme herbs and Fructus Ponciri Trifoliatae (Fructus Ponciri Trifoliatae Immaturus), Herba Scutellariae Barbatae, crown prince participate in 6 times of water gagings and fry in shallow oil and carry 3 times, fry in shallow oil the time of carrying to be followed successively by 1.5h, 1h, 0.5h at every turn, filter, and merging filtrate is evaporated to relative density 1.30～1.35 (50 ℃), II, subsequent use.With I, the abundant mixing of II, low-temperature reduced-pressure is dry, is ground into 80 order fine powders, adds debita spissitudo (85%) alcohol granulation with 20 mesh sieves, cold drying, and granulate, tabletting promptly get.
Embodiment 4 pills of the present invention
Get Fructus Ponciri Trifoliatae (Fructus Ponciri Trifoliatae Immaturus) 1600g, Herba Scutellariae Barbatae 2000g, Antenoron filiforme herb 1300g, Radix Pseudostellariae 1300g, add conventional adjuvant,, process pill according to common process.
Embodiment 5 powders of the present invention
Get Fructus Ponciri Trifoliatae (Fructus Ponciri Trifoliatae Immaturus) 1800g, Herba Scutellariae Barbatae 1500g, Antenoron filiforme herb 1400g, Radix Pseudostellariae 1100g, add conventional adjuvant,, process powder according to common process.
Claims (10)
1. a pharmaceutical composition of treating precancerous lesions of chronic atrophic gastritis is characterized in that the crude drug of this medicinal substances compositions consists of: Fructus Ponciri Trifoliatae (Fructus Ponciri Trifoliatae Immaturus) 10～20 weight portions, Herba Scutellariae Barbatae 15～30 weight portions, Antenoron filiforme herb 10～15 weight portions, Radix Pseudostellariae 10～20 weight portions.
2. pharmaceutical composition as claimed in claim 1 is characterized in that the crude drug of this medicinal substances compositions consists of: Fructus Ponciri Trifoliatae (Fructus Ponciri Trifoliatae Immaturus) 14 weight portions, Herba Scutellariae Barbatae 16 weight portions, Antenoron filiforme herb 10 weight portions, Radix Pseudostellariae 10 weight portions;
Or Fructus Ponciri Trifoliatae (Fructus Ponciri Trifoliatae Immaturus) 11 weight portions, Herba Scutellariae Barbatae 28 weight portions, Antenoron filiforme herb 11 weight portions, Radix Pseudostellariae 18 weight portions.
3. pharmaceutical composition as claimed in claim 1 is characterized in that the crude drug of this medicinal substances compositions consists of: Fructus Ponciri Trifoliatae (Fructus Ponciri Trifoliatae Immaturus) 13 weight portions, Herba Scutellariae Barbatae 25 weight portions, Antenoron filiforme herb 12 weight portions, Radix Pseudostellariae 15 weight portions.
4. pharmaceutical composition as claimed in claim 1 is characterized in that the crude drug of this medicinal substances compositions consists of: Fructus Ponciri Trifoliatae (Fructus Ponciri Trifoliatae Immaturus) 16 weight portions, Herba Scutellariae Barbatae 20 weight portions, Antenoron filiforme herb 13 weight portions, Radix Pseudostellariae 13 weight portions.
5. pharmaceutical composition as claimed in claim 1 is characterized in that the crude drug of this medicinal substances compositions consists of: Fructus Ponciri Trifoliatae (Fructus Ponciri Trifoliatae Immaturus) 18 weight portions, Herba Scutellariae Barbatae 15 weight portions, Antenoron filiforme herb 14 weight portions, Radix Pseudostellariae 11 weight portions.
6. like described any one pharmaceutical composition of claim 1-5, it is characterized in that said Antenoron filiforme herb is that wine is processed Antenoron filiforme herb.
7. like described any one pharmaceutical composition of claim 1-5; It is characterized in that getting crude drug; Add conventional adjuvant; According to common process, process powder, tablet, granule, hard capsule, soft capsule, drop pill, pill, honeyed pill, soft extract with bee honey agent, microgranule, slow releasing preparation, controlled release preparation, quick releasing formulation, oral liquid or ejection preparation.
8. like described any one preparation of drug combination method of claim 1-5, it is characterized in that this method is:
Get 1/10～3/5 Antenoron filiforme herb, cold drying is ground into 100 orders～200 order fine powders, gets I, and is subsequent use; All the other Antenoron filiforme herbs and Fructus Ponciri Trifoliatae (Fructus Ponciri Trifoliatae Immaturus), Herba Scutellariae Barbatae, crown prince participate in 6～10 times of water gagings and fry in shallow oil and carry 2～4 times, and frying in shallow oil the time of carrying is 0.5h～2h, filter, and merging filtrate is evaporated to 50 ℃ of relative densities 1.30～1.35, II, subsequent use; With I, the abundant mixing of II, low-temperature reduced-pressure is dry, adds conventional adjuvant, according to common process, processes powder, tablet, granule, hard capsule, pill.
9. method for preparing as claimed in claim 8 is characterized in that this method is:
Get 1/3 Antenoron filiforme herb, cold drying is ground into 100 order fine powders, gets I, and is subsequent use; All the other Antenoron filiforme herbs and Fructus Ponciri Trifoliatae (Fructus Ponciri Trifoliatae Immaturus), Herba Scutellariae Barbatae, crown prince participate in 8 times of water gagings and fry in shallow oil and carry 3 times, fry in shallow oil the time of carrying to be followed successively by 1.5h, 1h, 0.5h at every turn, filter, and merging filtrate is evaporated to 50 ℃ of relative densities 1.30～1.35, II, subsequent use; With I, the abundant mixing of II, low-temperature reduced-pressure is dry, adds conventional adjuvant, according to common process, processes powder, tablet, granule, hard capsule, pill.
10. like the application of described any one pharmaceutical composition of claim 1-5 in the medicine of preparation treatment precancerous lesions of chronic atrophic gastritis.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| RU2519766C1 (en) * | 2013-03-05 | 2014-06-20 | Зухра Фаниловна Эделева | Method of treating gastritis |
| CN115444883A (en) * | 2022-10-19 | 2022-12-09 | 陕西中医药大学 | A Chinese medicinal powder composition for preventing and treating chronic atrophic gastritis and gastric precancerous lesion |
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2012
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| 《中华中医药学刊》 20110331 王捷虹 "中医"治未病"思想在胃癌高危人群干预中的应用" 第29卷, 第3期 * |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| RU2519766C1 (en) * | 2013-03-05 | 2014-06-20 | Зухра Фаниловна Эделева | Method of treating gastritis |
| CN115444883A (en) * | 2022-10-19 | 2022-12-09 | 陕西中医药大学 | A Chinese medicinal powder composition for preventing and treating chronic atrophic gastritis and gastric precancerous lesion |
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| CN102755418B (en) | 2014-09-17 |
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