| Background and purposeWei Nai An(WNA)capsule is a famous doctor Liang Naijin combined with decades of clinical experience,developed by the selection of drugs.The pro-duction has good effect on eliminating inflammation,protecting gastric muco-sa and alleviating gastralgia,etc,and also on gastric mucosa damage disease and great economic and social profits,which consists of Astragalus,Panax notoginseng,red ginseng,pearl layer powder,artificial bezoar.But since the production going into operation for many years,the preparation process and formulation has been no improvement,making the clinical dose is bigger.In order to further adapt to the consumer to put forward higher requirements of proprietary Chinese medicine,as well as the progress of modern advanced production technology,it is necessary to proceed the WNA capsule for secondary development,and gastric trouble in the prescription of relatively simple her-bs,the main active ingredient is clear,good secondary development feasibi-lity.And also,the prescription of herbs is relatively simple,meanwhile,the main active ingredient is clear,which provides a good secondary deve-lopment feasibility for it.Our earlier stage kept the original prescription no Change,through absor-bing and integrateding the modern extraction,separation,preparation techno-logy and other new technology and method in pharmacodynamics experiment under the guidance of the secondary development research,then got a new preparation(called new Wei Nai An tablet,the following are the same),which reduces the dose.So,whether it can maintain or enhance curative effect or not at the same time is the key link for the successful implementation of the secondary development.Therefore,this study references the WNA capsule clinical indic-ations and new drug application requirements,designs a series of gastrointe-stinal mucosa damage related models to investigate the new WNA tablet pharma-cological actions,and in the meantime,checks the effects against the original,expecting from the perspective of pharmacodynamics confirm the rationality and repeatability of the process parameters upfront,in order to provide sci-entific and objective of pharmacodynamic data for the secondary development to the success of the stomach is Ann capsule to provide scientific and objective of pharmacodynamic data,and to provide reliable results for the clinical research or the efficacy of clinical application in the future.MethodsThe clinical indications of fNA capsule include peptic ulcer,chronic superficial gastritis,atrophic gastritis,etc.So the new dosage forms of pharmacodynamics test design should be centered on the indications like figh-ting ulcer,suppression of acid,mucosal protection,adjusting gastrointes-tinal movement,antiinflammatory analgesic,etc.According to the new drug for declareation,the reagent should set high,medium and low three dose groups,a positive control drug group,model control group,and according to the characterristics of the studies in the project,we add the original drug treatment group so that we not only can know whether new dosage forms is effective or not,but also can compares the effects with the original.1.According to the“chronic gastritis" function,using Iodoacetamide(IAM)to establish chronic superficial gastritis model and adopting N-methyl-N’-nit ro-N-nitrosoguanidine(MNNG)to building the model of chronic atrophic gastri-tis,in order to study the new WNA tablet of prevention and control of chronic gastritis role.2.In order to research the new WNA tablets in gastrointestinal peristalsis and gastric secretion role,we use two models,one is mice gastric emptying test,another is gastric analysis experimental.3.Adopting hydrochloric acid ethanol,indomethacin,stress ulcer and chronic gastric ulcer four models respectively to evaluate the effect of new WNA tablet on gastric mucosa protection.4.We use three models to investigate the effect of new WNA tablet on anti-inflammatory and analgesic,they are xylene induced inflammation experiment.granuloma caused by cotton ball experiment and acetic acid induced pain exper-iment.Results1.the efficacy of new WNA tablet on the prevention and control of chronic gastritis(1)the role of chronic superficial gastritisFrom the macroscopic observation we can know,the new WNA tablet(2.18±1.43)and WNA capsule(2.56 ± 1.26)inflammation integral was significantly lower than the model group(4.39±1.42,P<0.01),the inflammatory inhibition rate respectively were 50.34%,41.69%,and from the microscopic observation we can see,the new WNA tablet(2.88 ±1.63)and WNA capsule(3.09±1.59)inflammation integral was significantly lower than the model group(5.00 ±1.38,P<0.01),the inflammatory inhibition rate respectively were 42.4%and 38.2%.(2)the role of chronic atrophic gastritisThe new WNA tablet(74.35±7.18)and WNA capsule(69.54±11.76)emptying rate was significantly higher than that of model group(48.60±7.77),but the differrrence is not statistically significant.2.the efficacy of new WNA tablet on the gastric function(1)the role of gastric emptyingThe emptying rate of the new WNA tablet(74.35±7.18%)and capsule(69.54± 11.76%)was significantly higher than the model group(48.60±7.77%,P<0.01),but the differrrence is not statistically significant.(2)the role of gastric acid and pepsin secretionCompared with model group,the data of the new WNA tablet and capsule in the following indicators including gastric secretion volume(3.58ml,4.78 ml),free acid(43mEq/L,80mEq/L),total acidity(99.5mEq/L,113.5mEq/L),total acid discharge(74.05uEq/h,109.14uEq/h),pepsin activity(663.04activity unit/h,906.21activity unit/h)and pepsin activity(478.21activity unit/ml,839.64 activity unit/ml)were significantly reduced(P<0.01,P<0.05).3.the efficacy of new WNA tablet on the the hydrochloric acid and gastric mucosa(1)the role of gastric ulcer induced by hydrochloric acidIn the model of ethanol induced gastric ulcer,the gastric ulcer index(UI)of the new WNA tablet(73.00±44.93)and capsule(94.17±71.03)was signific-antly lower than the model group(180.85 ± 60.28,P<0.01),ulcer inhibition rate were 59.64%、47.93%.(2)the role of gastric ulcer induced by indomethacinIn the model of indomethacin induced gastric ulcer,the UI of the new WNA tablet(5.4±4.248)and capsule(7.8±5.493)was significantly lower than the model group(21.5± 10.814,P<0.01,P<0.05),ulcer inhibition rate were 74.88%、63.72%.(3)the role of gastric mucosa damage induced by stress ulcerIn the model of stress ulcer,the UI of the new WNA tablet(18.07±5.98)and capsule(21.93±4.17)was significantly lower than the model group(35.79±13.89,P<0.01,P<0.05),ulcer inhibition rate were 49.51%、38.73%.(4)the role of chronic gastric ulcer induced by glacial acetic acidIn the model of chronic gastric ulcer,the UI of the new WNA tablet(0.39±0.14)and capsule(0.42 ± 0.05)was significantly lower than the model group(0.55±0.11,P<0.05),ulcer inhibition rate were 29.09%、23.64%.4.the efficacy of new WNA tablet on anti-inflammatory and analgesic(1)the role of acute inflammation caused by xyleneThe auricle of swelling degree of the new WNA tablet(3.560±2.491mg)and capsule(3.855±2.125mg)was significantly lower than the model group(5.708± 1.789mg,P<0.05),the ulcer inhibition rate respectively were 37.63%、32.46%.(2)the role of chronic inflammation caused by cotton ballThe granuloma weight of the new WNA tablet(80.60±9.69mg)and capsule(89.39± 12.18mg)was significantly lower than the model group(109.66±19.07mg,P<0.01),the ulcer inhibition rate respectively were 26.5%、18.48%.(3)the role of pain caused by glacial acetic acidThe writhing times of the new WNA tablet(9.33±9.55times)and capsule(12.62±11.82times)was significantly lower than the model group(36.25 ± 13.11 times,P<0.01),but there is no statistically significant difference between them.ConclusionThe new WNA tablet has good therapeutical effect on the following several aspects such as fighting ulcer,suppression of acid,mucosal protection,adju-sttting gastrointestinal movement and anti-inflammatory analgesic.And in the same doses,the curative effect has a tendency to increase is a little better than the WNA capsule,Compareing with the WNA capsule,the new WNA tablet has a tendency to enhance the curative effect. |
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