CN1140080A - Stomach-recovering capsule - Google Patents
Stomach-recovering capsule Download PDFInfo
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- CN1140080A CN1140080A CN96102623A CN96102623A CN1140080A CN 1140080 A CN1140080 A CN 1140080A CN 96102623 A CN96102623 A CN 96102623A CN 96102623 A CN96102623 A CN 96102623A CN 1140080 A CN1140080 A CN 1140080A
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- rhizoma
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- gastric
- gastric disease
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- Medicinal Preparation (AREA)
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Abstract
A capsule for curing gastral cavity pain, gastric ulcer and gastritis without any toxic by-effect and obvious gastroentestinal reaction is prepared from 6 Chinese-medicinal materials such as coptis root, evodia fruit, pinellia tuber, tangerine peel, chicken's gizzard-skin and dried sodium sulfate.
Description
The present invention relates to a kind of medicine for the treatment of the gastric abscess of intermingling cold and heat, lifting imbalance, specifically is the Chinese patent medicine of feedstock production with the Chinese herbal medicine; The invention still further relates to the preparation method of this medicine.
Gastric abscess is clinical common frequently-occurring disease, mainly comprises the various gastritis and the peptic ulcer of modern medicine.Motherland's medical science is thought the generation and the improper diet of primary disease, and feelings will is smooth, invade in the exopathogen, due to the gas of impairing the spleen and stomach.Main pathology is changed to dysfunction of the spleen in transportation, liver and loses orderly and clearly, stomach-QI being unable to descend normally, middle burnt retardance, intermingling cold and heat; Clinical manifestation is gently then based on epigastrium feeling of fullness feeling of distension and oppression, heavy then gastralgia, and can hold a sinecure that desire is depressed, belch, pantothenic acid, nausea and vomiting, constipation with dry stool or rare half congealed etc.
Though some Chinese patent medicines for the treatment of gastropathy such as a kind of stomach medicine and preparation method thereof CN1083717A is also arranged, and actual effect is not fairly obvious.
The purpose of this invention is to provide a kind of gastrotherapy agent with effects such as pungent drugs can disperse and bitter drugs can descend, the flat profit of cold and heat, convergence antacid, sending down the abnormal ascending QI pain relievings.
Another object of the present invention provides the preparation method of this gastrotherapy agent.
The object of the present invention is achieved like this: a kind of Weikang capsule for curing gastric disease, its Main Ingredients and Appearance are the medicaments of being made by the following weight proportion raw material
The Rhizoma Coptidis 60 gram Fructus Evodiaes 30 gram Rhizoma Pinelliaes 100 grams
Pericarpium Citri Reticulatae 100 gram Endothelium Corneum Gigeriae Galli 100 gram Matrii Sulfas Exsiccatus 30 grams
Wherein the Rhizoma Pinelliae is the Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) through the Sucus Zingberis Alumen processing process of preparing Chinese medicine, and Endothelium Corneum Gigeriae Galli is fried surperficial dark yellow brown to coke yellow for doing.The indication medicament is a said dosage form on any pharmaceutics.Said medicament is a capsule.
The preparation method of Weikang capsule for curing gastric disease be get Fructus Evodiae, Pericarpium Citri Reticulatae places baking oven, in 60-80 ℃ drying 1 hour, takes out cooling; Get Rhizoma Coptidis, the Rhizoma Pinelliae, Endothelium Corneum Gigeriae Galli, Matrii Sulfas Exsiccatus and put in the baking oven, in 80-100 ℃ of drying 3 hours, take out put cold; Get Rhizoma Coptidis, Fructus Evodiae, the Rhizoma Pinelliae, Pericarpium Citri Reticulatae, the Endothelium Corneum Gigeriae Galli mixed powder that drying puts after cold and be broken into fine powder, cross sieve No. five, mixing; Get dried Matrii Sulfas Exsiccatus, be ground into fine powder fast, plastic bag sealing is standby; Adopt the equivalent incremental method, Matrii Sulfas Exsiccatus and other medicated powder are ground well, sieve; Get the medicated powder behind the above mix homogeneously, adopt during the capsule subpackage device incapsulates.
Because the present invention is made up of pure Chinese medicines of Six-element such as Fructus Evodiae, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens), Rhizoma Coptidis, have effects such as the liver of accent stomach function regulating, pungent drugs can disperse and bitter drugs can descend, coordination of cold and heat, convergence antacid, sending down the abnormal ascending QI pain relieving.
Clinical drug of the present invention uses the result to show that following advantage is arranged: this medicine all has obvious suppression and protective effect to acute ulcer, chronic ulcer and drug-induced ulcer or gastric mucosa injury; Can suppress gastric secretion, thereby reach the generation and the protection ulcer surface of anti-peptic ulcer, promote ulcer healing; Also have tangible analgesia and antiinflammatory action simultaneously, this is a kind of advantage to the treatment peptic ulcer, also provides theoretical foundation for treating acute and chronic gastritis.
Below in conjunction with drawings and Examples the present invention is further described.
Fig. 1 is a process chart of the present invention.
Embodiment 1:
The Rhizoma Coptidis 60 gram Fructus Evodiaes 30 gram Rhizoma Pinelliaes 100 grams
Pericarpium Citri Reticulatae 100 gram Endothelium Corneum Gigeriae Galli 100 gram Matrii Sulfas Exsiccatus 30 grams
Its production method is as follows:
1, the process of preparing Chinese medicine of medical material: the Rhizoma Pinelliae has the effect of stopping nausea and vomiting by lowering the adverse flow of QI, Rhizoma Pinelliae is poisonous, can make when eating raw tongue, pharynx and oral cavity produce numb, swell and ache, toxic and side effects such as sialorrhea, difficulty in opening mouth, so for oral administration generally need not, and with processing the Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) of the process of preparing Chinese medicine through Sucus Zingberis, Alumen.Endothelium Corneum Gigeriae Galli has the effect that activating the spleen helps digestion, controlling nocturnal emission with astringent drugs ends something lost.Activating the spleen helps digestion uses Endothelium Corneum Gigeriae Galli (parched)s, controlling nocturnal emission with astringent drugs to end losing to use the live chickens Endothelium corneum more more, so this product is selected Endothelium Corneum Gigeriae Galli (parched) for use.Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens), Endothelium Corneum Gigeriae Galli, Rhizoma Coptidis, Fructus Evodiae, Pericarpium Citri Reticulatae, Matrii Sulfas Exsiccatus are all by concocting method conventional treatment of Chinese Pharmacopoeia nineteen ninety version.
2, the drying of medical material: Fructus Evodiae contains volatile oil such as evodene, ocimene, obaculactone, evodol in this product prescription, contain volatile oil such as citral, limonene, n-capric aldehyde, capryl alcohol in the Pericarpium Citri Reticulatae, both are baking for a long time at high temperature, volatile oil is scattered and disappeared, thereby influence the nature and flavor and the curative effect of medicine, so adopt 60-80 ℃ of cold drying 1 hour.Rhizoma Coptidis, the Rhizoma Pinelliae, Endothelium Corneum Gigeriae Galli, Matrii Sulfas Exsiccatus do not contain volatile ingredient, in 80-100 ℃ of drying 3 hours, can guarantee the property of medicine, and moisture is reduced to about 5%, are convenient to pulverize.
3, the pulverizing of medical material: Rhizoma Coptidis, Fructus Evodiae, the Rhizoma Pinelliae, Pericarpium Citri Reticulatae, Endothelium Corneum Gigeriae Galli quality are similar, mix comminuting method and are ground into fine powder so adopt.Matrii Sulfas Exsiccatus is a mineral drug, and the powder that is white in color is so adopt polishing directly further to pulverize; Because of its have draw moist, easy deliquescence, thus should grind fast when operating, and standby with plastic bag sealing.
4, the mixing of medicated powder: Matrii Sulfas Exsiccatus is a mineral drug, and matter is heavy, is difficult to direct mixing with other medicated powder, so employing equivalent incremental method makes itself and other abundant mixing of medicated powder.Behind the medicine homodisperse, can guarantee the safe and effective of product quality and medication.
5, the selection of dosage form: this product is the former powder oral capsule of Chinese medicine, and at the beginning of development, what patient took is this medicine medicated powder, because this medicated powder flavor is extremely bitter, hot, the mouthfeel extreme difference, and zest is strong, dose a patient with and bring inconvenience, so later the former powder of crude drug is made water pill, though taking more before, patient makes things convenient for, but owing to contain Matrii Sulfas Exsiccatus in this medicated powder, have draw moist, even coated processing also is difficult to storage of a specified duration, and patient's taking dose is difficult for accurately grasping.Select the former powder tablet of Chinese medicine for use, preparation technology is complicated, and must carry out coating, and taking dose increases, and disintegration is long than capsule, and the curative effect performance wants slower.Select dosage forms such as mixture, syrup, electuary for use, need the lixiviate of process high-temperature water to get and concentrate, the contained volatile ingredient of Fructus Evodiae and Pericarpium Citri Reticulatae completely loses in the prescription, and high temperature can destroy other effective ingredient for a long time, affects the treatment; Because of containing Rhizoma Coptidis mouthfeel extreme difference, patient is difficult to accept, and is difficult for long-time storage.Because all there is weak point in above dosage form, so determine to select for use capsule at last.Because of capsule not only can keep writing out a prescription in the property of medicine and the effective ingredient of each medicine, and softgel shell can cover oral bitterness of crude drug powder and zest, takes the back softgel shell in the rapid disintegrate of gastric, not only guaranteed curative effect, and curative effect can be brought into play rapidly; Capsule also is convenient to store in addition, can prevent to draw moist, is the comparatively ideal at present dosage form of this product.Through clinical verification, select this dosage form for use, obtained comparatively stable curative effect.
For substantive distinguishing features of the present invention and effectiveness are described better, be described in detail its function below in conjunction with pharmacology, pharmacodynamics, clinical trial.
One, the pharmacodynamics test of Weikang capsule for curing gastric disease treatment gastric abscess.
Test material
Be subjected to reagent thing Weikang capsule for curing gastric disease to build street hospital lot number is provided by Zigui County Gui Zhou town: 940701, every capsule includes 0.35g crude drug powder, is mixed with suspension with 0.5% sodium carboxymethyl cellulose before the test.
Positive control drug ranitidine capsule is Minsheng Pharmaceutical Factory, Hangzhou City.'s product, lot number: 940981,0.15g/, make solution before the test.SANJIU WEITAI JIAONANG is Nanfang Pharmaceutical Factory's product, lot number: 940803,0.35g/, make suspension with 0.5% carboxymethylcellulose sodium solution before the test.
Experimental animal: Kunming mouse, the 18-22 gram/only, and the wistar rat, the 180-220 gram/only, male and female have concurrently.
Test method is with reference to " herbal pharmacology research methodologies " such as Qi Chens, People's Health Publisher, 1993,67,70,461,462.Li Yikui " herbal pharmacology experimental methodology " Science and Technology of Shanghai publishing house 1991,241,242,353,454,456.
1, anti-peptic gastric ulcer test
Each treated animal of administration and dosage is all at preceding 45 minutes single administrations of modeling.
Three dosage of Weikang capsule for curing gastric disease are respectively 1.60,0.80,0.40g/Kg.d is equivalent to expect clinical dosage respectively 2.34 times, 1.17 times and 0.59 times; Ranitidine is 0.06g/Kg.d, is equivalent to 1.54 times of clinical dosage.Above dosage all converts by body surface area.
The ulcer index of result of the test blank treated animal model and administration group more all are significant difference (p＜0.01), the large, medium and small dosage of Weikang capsule for curing gastric disease is dose-effect relationship to the suppression ratio of mice stress ulcer, and the heavy dose of group of Weikang capsule for curing gastric disease compares there was no significant difference (p＞0.05) with the ranitidine positive drug.Result of the test sees Table 1
Table 1 Weikang capsule for curing gastric disease is to effect group dosage number of animals ulcer index (mm) suppression ratio of mice stress ulcer
(g/Kg) (only) ((%) blank group 20ml 12 27.03 ± 2.82 stomach health groups 1.60 12 6.33 ± 2.97** 76.58 of X ± SD)
0.80 12 11.56±4.52** 57.24
0.40 12 20.88 ± 4.27**, 22.77 ranitidine groups, 0.06 12 6.13 ± 2.89** 77.34 compares with the blank group: * * P＜0.01
Three kinds of dosage of stomach health are 1.0,0.5,0.25g/Kg.d, are equivalent to 1.11 times of clinical dosage, and above dosage all converts by body surface area.
The ulcer area of result of the test blank treated animal model and ulcer index and each administration group are relatively, all be significant difference (p＜0.01), the large, medium and small dosage of stomach health is dose-effect relationship to the effect of rat pyloric ligation ulcers gastric ulcer model, wherein the heavy dose of group of stomach health compares there was no significant difference (P＞0.05) with ranitidine positive drug group, and result of the test sees Table 2.
Table 2 Weikang capsule for curing gastric disease is to effect group dosage number of animals ulcer area (mm) ulcer index of rat pyloric ligation ulcers ulcer
(g/Kg) (only) ((blank group (N, S) 10ml 11 48.03 ± 23.74 3.09 ± 0.70 stomach health groups (greatly), 1.00 11 2.43 ± 3.41**, 0.82 ± 0.75** of x ± SD) of X ± SD)
(in) 0.5 10 8.20 ± 8.64**, 1.40 ± 0.84**
(little) 0.25 11 15.38 ± 9.05**, 1.91 ± 0.94** ranitidine group, 0.03 10 3.30 ± 3.07**, 0.80 ± 0.63** and blank group compare: * * P＜0.01.
The anti-acute gastric ulcer result of the test of brief summary Weikang capsule for curing gastric disease shows, all has significant therapeutic effect to mice stress gastric ulcer model with to rat pyloric ligation ulcers gastric ulcer model.Large, medium and small three kinds of dosage groups of stomach health and blank group relatively all are significant difference (p＞0.01), and wherein heavy dose of group compares there was no significant difference (P＞0.05) with similar positive drug ranitidine group.
Table 3 Weikang capsule for curing gastric disease causes effect group dosage number of animals ulcer area (mm) the ulcer index ulcer healing rate of coat of the stomach damage to rat acetic acid calcination method
(g/Kg) (only) (((%) blank group (N, S) 10ml 10 58.03 ± 34.86 3.50 ± 0.85 stomach health groups (greatly), 1.00 10 10.44 ± 8.94**, 1.30 ± 0.95** 57.91 of x ± SD) of X ± SD)
(in) 0.5 9 14.65 ± 9.02**, 1.67 ± 1.00** 50.15
(little) 0.25 9 37.24 ± 23.88 2.78 ± 0.83** 20.52 ranitidine groups 0.03 10 11.62 ± 8.06**, 1.40 ± 0.84** 55.60 compares with the blank group: * * P＜0.01.
The anti-chronic gastric ulcer result of the test of brief summary Weikang capsule for curing gastric disease shows that it causes rat acetic acid calcination method has better treatment and protective effect to the coat of the stomach damage model.Wherein large, medium and small three kinds of dosage groups and blank group relatively have significant difference (p＜0.01), and small dose group also has certain therapeutical effect, and heavy dose of group compares there was no significant difference (P＞0.05) with similar medicine ranitidine group.
" Weikang " capsule brings out gastric ulcer or the gastric mucosa injury test shows, gastric ulcer model due to the mouse subcutaneous injection reserpine and the oral ethanol gastric mucosa injury of mice model are all had significant therapeutic effect, and its large, medium and small three kinds of dosage groups and blank group more all are significant difference (p＜0.01); The therapeutic effect of its heavy dose of group slightly is better than similar medicine ranitidine, obviously is better than SANJIU WEITAI, the therapeutic equivalence of middle dosage and SANJIU WEITAI; The effect of the large, medium and small dosage of stomach health is dose-effect relationship.
Table 4 Weikang capsule for curing gastric disease is to effect group dosage number of animals ulcer area (mm) ulcer index of ulcer due to the mouse subcutaneous injection reserpine
(g/Kg) (only) ((blank group (N, S) 20ml 12 25.77 ± 12.73 2.50 ± 0.52 stomach health groups (greatly), 1.60 12 2.03 ± 2.33**, 0.75 ± 0.45** of x ± SD) of X ± SD)
(in) 0.80 12 4.87 ± 6.34**, 0.92 ± 0.51**
(little) 0.40 12 8.24 ± 2.69**, 1.50 ± 0.52** ranitidine group, 0.06 12 2.42 ± 1.51**, 0.83 ± 0.39** and blank group compare: * * P＜0.01.
Table 5 Weikang capsule for curing gastric disease is to effect group dosage number of animals ulcer area (mm) ulcer index of gastric mucosa injury due to the oral ethanol of mice
(g/Kg) (only) ((blank group (N, S) 20ml 12 69.93 ± 42.32 3.50 ± 1.09 stomach health groups (greatly), 1.60 12 2.45 ± 2.46**, 0.67 ± 0.49** of x ± SD) of X ± SD)
(in) 0.80 12 5.49 ± 6.04**, 1.00 ± 0.74**
(little) 0.40 12 30.69 ± 18.45**, 2.42 ± 0.90** ranitidine group, 0.06 12 5.63 ± 5.18**, 1.00 ± 6.03** and blank group compare: * * P＜0.01.
2, gastrointestinal function is tested: to the excretory influence of ligation pylorus rat gastric juice, result of the test sees Table 6.
Administration and dosage: each treated animal successive administration 7 days, every day 1 time, (the blank group was given physiology
Table 6 Weikang capsule for curing gastric disease is to excretory group dosage number of animals gastric juice amount gastric acidity (mol/L) pepsin activity that influences of ligation pylorus rat gastric juice
(g/Kg), (only), (ml) free acid total acid, (μ g/ml/min) blank group, (NS) 20ml 12 9.04 ± 1.35 65.4855 ± 10.9733 112.4945 ± 14.5679 3.3030 ± 0.4463 9 Ling Weikang group, (greatly) 1.60 12 4.65 ± 0.88**, 25.0393 ± 14.3565** 74.8227 ± 19.9513** 2.6002 ± 0.7453**
(in) 0.80 12 6.79 ± 1 70** 34.1210 ± 9.4914**, 86.2200 ± 12.0106**, 2.9308 ± 0.4295**
(little) 0.40 12 8.09 ± 1.20 44.2170 ± 7.7979**, 103.0690 ± 11.6042** 2.8105 ± 0.5810** ranitidine group 0.06 12 5.07 ± 0.82**, 20.8970 ± 12.2400** 62.3870 ± 9.3452** 2.3832 ± 0.4886**
Compare with the blank group: * * P＜0.01.0.5% carboxymethylcellulose sodium solution of saline preparation), isolate fasting after the 5th administration, underwent surgery in 24 hours after the 6th administration, the ligation pylorus, and carry out the 7th administration in duodenum.
Three kinds of dosage of stomach health are 1.0,0.5,0.25g/Kg.d, are equivalent to expect 2.12,1.06,0.53 times of clinical dosage respectively; The dosage of ranitidine is 0.03g/Kg.d, is equivalent to 1.11 times of clinical dosage.Below all convert by body surface area.
Brief summary
Weikang capsule for curing gastric disease shows the test of ligation pylorus rat gastric secretion influence, and it is to suppressing gastric secretion, and reducing gastric acidity (comprising free acid and total acidity) and pepsin output has significant effect; The big or middle dosage group of stomach health surveys every index and the blank group compares, and has significant difference (p＜0.01); Stomach health low dose also has certain influence to gastric secretion, and it suppresses gastric secretion and pepsic output of reduction and blank and more also is significant difference (p＞0.01); Heavy dose of group institute's every index of surveying of stomach health and positive drug ranitidine group comparison there was no significant difference (p＞0.05).
3, analgesic activity
Weikang capsule for curing gastric disease shows that to the analgesic experiment of mouse writhing method and electricity irritation tail-flick method three kinds of agent reach 45-68% to the suppression ratio of turning round body, and pain threshold raising rate reaches 68%-308%, more all is remarkable difference with the blank group, (P＜0.001); Its analgesic effect is better than positive controls medicine SANJIU WEITAI (turning round body suppression ratio and pain threshold raising rate branch is 42.65% and 68% in addition).
4, antiinflammatory action
Weikang capsule for curing gastric disease antiinflammatory result of the test shows, with the various dose gastric infusion, Ovum Gallus domesticus album caused rat paw edema and dimethylbenzene bring out the Mice Auricle edema obvious suppression effect is all arranged.Wherein, the stomach health is better than positive drug SANJIU WEITAI (big or middle dosage) or similar to positive drug (low dose) to the inhibitory action that Ovum Gallus domesticus album causes rat; Xylol brings out the inhibitory action of Mice Auricle edema, and three kinds of dosage of stomach health all are better than positive control drug.
Conclusion
The pharmacodynamics test of Weikang capsule for curing gastric disease is to cure mainly and according to the requirement of Chinese medicine three kind new medicines design, carried out the research of aspects such as anti-peptic ulcer, gastrointestinal function, analgesic test, antiinflammatory test according to its function, comprises 10 contents of the test.Result of the test shows that Weikang capsule for curing gastric disease all has obvious suppression and protective effect to acute gastric ulcer, chronic gastric ulcer and drug-induced gastric ulcer or gastric mucosa injury; The gastric analysis test shows that this medicine can suppress gastric secretion, reduces gastric acid and pepsic output, thereby reduce gastric juice to proteinic digestion, reduce the stimulation of gastric acid, reach the generation and the protection ulcer surface of anti-peptic ulcer, and then promote ulcer healing ulcer surface; Weikang capsule for curing gastric disease also has tangible analgesia and antiinflammatory action, may be a kind of advantage to the treatment peptic ulcer, treats acute and chronic gastritis when being both theoretical foundation is provided.
Above-mentioned result of study confirms that the pharmacodynamics effect of Weikang capsule for curing gastric disease is obvious, and its most pharmacology indexs are better than or are equivalent to positive controls such as SANJIU WEITAI, ranitidine, for further research acute and chronic gastritis of this Drug therapy and peptic ulcer provide scientific basis.
Two, toxicologic study
The Weikang capsule for curing gastric disease prescription drug is a conventional Chinese medicine, does not have the incompatibility of eighteen incompatible medicaments, nineteen medicaments of mutual restraint in the side.With reference to the specification requirement of " study of tcm new drug guide " relevant toxicologic study, carried out toxicity test.
The acute toxicity tests shows, the median lethal dose(LD 50) LD50 of Weikang capsule for curing gastric disease is 4.21g/Kg (calculates by kg body weight, be equivalent to expect 48 times of clinical medicine dose), 95% the credible 4.24 ± 0.55g/Kg that is limited to; Its low dose (2.07g/Kg), calculate by kg body weight be equivalent to expect 24 times of clinical medicine dose), disposable administration, none is only dead for 10 mices, and mice is not produced tangible toxic action.It is clinical safer to illustrate that this medicine is used for.
Long term toxicity test is the result show, Weikang capsule for curing gastric disease with 2.10,1.05,0.525g (medicated powder)/Kg (calculates by kg body weight, be equivalent to expect early 24,12,6 times of clinical application agent, its low dose is higher than the pharmacodynamics effective dose) three kinds of continuous 10 weeks of gastric infusion of dosage, convalescent period observed for 2 weeks, observation through general signs, body weight, behavior, blood cell and blood biochemical are learned the inspection of index, the perusal of important organ and the calculating of organ coefficient, and aspect such as histopathologic examination is comprehensively examined or check.Rare slightly except that the animal wastes of heavy dose group minority, hair color changes slightly and liver and mucous membrane of small intestine occur the slight pathological change, in, small dose group animal and heavy dose of group most animals do not see tangible toxic reaction.Each treated animal is at equal none rats death of administration and convalescent period.In addition, during restoration or the end of term, the residue animal is carried out the observation and the detection of above-mentioned identical items, each treated animal does not see that tangible toxic reaction and toxicity change.The heavy dose that shows this medicine is reversible in the administration phase to toxic reaction and the damaging pathological changes that minority animal related item is caused, and is easy to recover, and can not produce any retardance toxicity.Thereby illustrate Weikang capsule for curing gastric disease recommend clinical medicine dose (the 5.25g/ adult. day) will be safe.
Three, stability test
Specification requirement according to " provisions for new drugs approval " relevant stability of drug products test, this product has been examined or check its stability under terms of packing, carried out (T=40 ℃ of the test of natural storage-stable, light stability test and low temperature accelerated test, RH=75%), the investigation time is three months, and nature storage-stable test continuity was examined or check to 1 year.Detect respectively at 0,1,2,3,6,12 month, its character, discriminating, moisture, disintegration, assay, health examination have no significant change, and meet the regulation of this product quality standard.According to the regulation of (87) No. 268 files of Ministry of Public Health pharmaceutical control and administration, prediction Weikang capsule for curing gastric disease effect duration can reach 2 years.
Four, clinical trial
Weikang capsule for curing gastric disease treatment group is totally 110 examples, inpatient's 82 examples wherein, outpatient's 28 examples; Male's 75 examples, women's 35 examples, men and women's ratio is 2.1: 1; Patient age 19-67 year, 19-29 year 15 examples wherein, 30-39 year 38 examples, 40-49 year 26 examples, 50-59 year 20 examples, 11 examples more than 60 years old; Patient's course of disease did not wait in 2 months-30 years, and wherein 1 year with interior 13 examples, 1-3 51 examples, 46 examples more than 3 years.Press tcm syndrome differentiation and typing, belong to Qi-stagnation type 53 examples, stagnated heat type 26 examples, intermingling cold and heat 31 examples.By doctor trained in Western medicine name of disease classification, gastritis 75 examples, exudative gastritis 53 examples of erythema wherein, smooth erosive gastritis 6 examples, atrophic gastritis 15 examples, hemorrhagic gastritis 1 example; Peptic Ulcers 59 examples, gastric ulcer 24 examples wherein, duodenal bulbar ulcer 35 examples.
Matched group 40 examples, inpatient's 36 examples wherein, outpatient's 4 examples; Male's 23 examples, women's 17 examples, men and women's ratio is 1.4: 1; Patient age 18-67 year, 18-29 year 9 examples wherein, 30-39 year 13 examples, 40-49 year 12 examples, 50-59 year 2 examples, 4 examples more than 60 years old; Year do not wait surplus patient's course of disease 3 months-20, wherein 1 year with interior 8 examples, 1-3 17 examples, 15 examples more than 3 years.Press tcm syndrome differentiation and typing, belong to Qi-stagnation type 20 examples, stagnated heat type 11 examples, intermingling cold and heat 9 examples.By doctor trained in Western medicine name of disease classification, gastritis 27 examples, exudative gastritis 20 examples of erythema wherein, atrophic gastritis 5 examples, protuberance erosive gastritis 2 examples; Peptic Ulcers 15 examples, gastric ulcer 5 examples wherein, duodenal bulbar ulcer 10 examples.
Weikang capsule for curing gastric disease treatment group 80 examples and matched group 40 examples (SANJIU WEITAI matched group 19 examples, ranitidine matched group 21 examples), treat last as situation relatively, treat preceding two groups of there are no significant aspect sex, age, the course of disease and tcm syndrome differentiation and typing differences, have comparability.
The therapeutic effect of Weikang capsule for curing gastric disease:
Weikang capsule for curing gastric disease is treated 110 routine gastric abscess patients, and therapeutic effect is clinical recovery 19 examples, (17.3%), produce effects 56 examples (50.9%), effective 31 examples (28.2%), invalid 4 examples (3.6%); Obvious effective rate 68.2%, total effective rate 96.4%.
Stomach health treatment group 80 examples compare with matched group 40 routine curative effects, and the stomach health reaches the obvious effective rate that ends stomachache at the treatment gastric abscess and all obviously is better than matched group, significant difference.The obvious effective rate of stomach health treatment Peptic Ulcers and gastritis is excellent than ranitidine and SANJIU WEITAI respectively, and comparing difference is remarkable between group, and from the gastroscopy effect analysis, to Peptic Ulcers, the stomach health is suitable with the ranitidine effect; To gastritis, the curative effect of stomach health is better than SANJIU WEITAI, significant difference.Aspect the untoward reaction after taking medicine, the treatment of stomach health is organized none example and gastrointestinal reaction and other side effect are occurred.The ranitidine matched group then has side effect such as obviously feeling sick appears in some cases, loss of appetite.The therapeutic effect of this explanation stomach health is better than SANJIU WEITAI, and is suitable with ranitidine, but do not have the side reaction of ranitidine, thereby is the active drug of treatment gastric abscess.
Stomach health treatment gastric abscess, to Qi-stagnation type, stagnated heat type, intermingling cold and heat curative effect basically identical, curative effect no significant difference between three types, this and our medicine are transferred the liver stomach function regulating in forming, pungent drugs can disperse and bitter drugs can descend, sending down the abnormal ascending QI analgesic effect characteristics match.Stomach health treatment Peptic Ulcers and gastritis, its clinical observation on the therapeutic effect no significant difference, but gastroscopy effect shows that stomach health treatment Peptic Ulcers curative effect is better than gastritis.This may to study course of treatment observing time relevant with this, if the extended treatment time, perhaps can improve the curative effect of treatment gastritis.
The characteristics of stomach health
1, the stomach health is made up of pure Chinese medicines of Six-element such as Fructus Evodiae, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens), Rhizoma Coptidis, has effects such as the liver of accent stomach function regulating, pungent drugs can disperse and bitter drugs can descend, the flat profit of cold and heat, sending down the abnormal ascending QI pain relieving.
2, Weikang capsule for curing gastric disease treatment gastric abscess, its curative effect obviously is better than SANJIU WEITAI and ranitidine, is suitable for the treatment of Qi-stagnation type, stagnated heat type, intermingling cold and heat gastric abscess.
3, stomach health treatment Peptic Ulcers and gastritis, its curative effect obviously is better than SANJIU WEITAI and ranitidine, and does not have the side effect of ranitidine.
4, the Weikang capsule for curing gastric disease clinical practice is without any side effects, does not have tangible gastrointestinal reaction.
Claims (6)
1, a kind of Weikang capsule for curing gastric disease is characterized in that it is the medicament of being made by the following weight proportion raw material
The Rhizoma Coptidis 60 gram Fructus Evodiaes 30 gram Rhizoma Pinelliaes 100 grams
Pericarpium Citri Reticulatae 100 gram Endothelium Corneum Gigeriae Galli 100 gram Matrii Sulfas Exsiccatus 30 grams
2, Weikang capsule for curing gastric disease according to claim 1 is characterized in that the Rhizoma Pinelliae is the Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) of concocting through Sucus Zingberis, Alumen processing.
3, Weikang capsule for curing gastric disease according to claim 1 is characterized in that Endothelium Corneum Gigeriae Galli is to do to fry surperficial dark yellow brown to coke yellow.
4, Weikang capsule for curing gastric disease according to claim 1 and 2 is characterized in that said medicament is a said dosage form on any pharmaceutics.
5, Weikang capsule for curing gastric disease according to claim 4 is characterized in that said medicament is a capsule.
6, Weikang capsule for curing gastric disease according to claim 5 is characterized in that getting Fructus Evodiae, Pericarpium Citri Reticulatae places baking oven, in 60-80 ℃ drying 1 hour, takes out cooling; Get Rhizoma Coptidis, the Rhizoma Pinelliae, Endothelium Corneum Gigeriae Galli, Matrii Sulfas Exsiccatus and put in the baking oven, in 80-100 ℃ of drying 3 hours, take out put cold; Get Rhizoma Coptidis, Fructus Evodiae, the Rhizoma Pinelliae, Pericarpium Citri Reticulatae, the Endothelium Corneum Gigeriae Galli mixed powder that drying puts after cold and be broken into fine powder, cross sieve No. five, mixing; Get dried Matrii Sulfas Exsiccatus, be ground into fine powder fast, plastic bag sealing is standby; Adopt the equivalent incremental method, Matrii Sulfas Exsiccatus and other medicated powder are ground well, sieve; Get the medicated powder behind the above mix homogeneously, adopt during the capsule subpackage device incapsulates.
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| Application Number | Priority Date | Filing Date | Title |
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| CN96102623A CN1049148C (en) | 1996-01-25 | 1996-01-25 | Stomach-recovering capsule |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN96102623A CN1049148C (en) | 1996-01-25 | 1996-01-25 | Stomach-recovering capsule |
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| CN1140080A true CN1140080A (en) | 1997-01-15 |
| CN1049148C CN1049148C (en) | 2000-02-09 |
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| CN96102623A Expired - Fee Related CN1049148C (en) | 1996-01-25 | 1996-01-25 | Stomach-recovering capsule |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1087622C (en) * | 1999-06-22 | 2002-07-17 | 于盈光 | Chinese patent medicine for treating chronic gastritis and peptic ulcer |
| CN102973765A (en) * | 2012-11-16 | 2013-03-20 | 宜昌市九灵中医药研究所 | Traditional Chinese medicine used for treating gastrosis and preparation method thereof |
| CN107875186A (en) * | 2017-11-22 | 2018-04-06 | 甘肃神农文峰药业有限公司 | A kind of place of production of genunie medicinal materials Radix Codonopsis is without sulphur processing method |
-
1996
- 1996-01-25 CN CN96102623A patent/CN1049148C/en not_active Expired - Fee Related
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1087622C (en) * | 1999-06-22 | 2002-07-17 | 于盈光 | Chinese patent medicine for treating chronic gastritis and peptic ulcer |
| CN102973765A (en) * | 2012-11-16 | 2013-03-20 | 宜昌市九灵中医药研究所 | Traditional Chinese medicine used for treating gastrosis and preparation method thereof |
| CN102973765B (en) * | 2012-11-16 | 2014-07-23 | 宜昌市九灵中医药研究所 | Traditional Chinese medicine used for treating gastrosis and preparation method thereof |
| CN107875186A (en) * | 2017-11-22 | 2018-04-06 | 甘肃神农文峰药业有限公司 | A kind of place of production of genunie medicinal materials Radix Codonopsis is without sulphur processing method |
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| Publication number | Publication date |
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| CN1049148C (en) | 2000-02-09 |
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Assignee: Hubei Minkang Pharmaceutical Co., Ltd. Assignor: Li Daoxin|Li Fei Contract fulfillment period: 2008.10.16 to 2014.10.16 contract change Contract record no.: 2009420000001 Denomination of invention: Medicine for curing gastropathy Granted publication date: 20000101 License type: Exclusive license Record date: 2009.1.9 |
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Inventor after: Li Daoxin Inventor after: Li Fei Inventor after: Han Qingbin Inventor after: Li Suyu Inventor after: Li Zhanxiang Inventor after: Xu Chaoqing Inventor before: Li Daoxin Inventor before: Li Fei |
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