Studies On The JiangBai Tablet, A Traditional Chinese Compound Medicine In Anti-peptic

Peptic ulcer primarily occurred in the stomach and duodenum,is a common chronic gastrointestinal diseases.According to its clinical symptoms Peptic ulcer is vested in "Stomachache" category in traditional Chinese medicine.JiangBai Tablet is a compound Chinese medicine on gastric ulcer,containing extraction of Galangal, Cyperus rotundus,lily,and Lindera aggregata.The drug used in this study is JiangBai powder,brown-red,aromatic and spicy.Ethanol-induced gastric ulcer rat model,stress ulcer rat model,pyloric ligation ulcer rat model,acetic acid ulcer rat model,Helicobacter pylori Infection mouse model and Acetic acid achy mouse model were successfully cloned.The protection and therapeutic effects of JiangBai Powder in different doses were investigated on those models.Ulcer index,gastric volume,gastric juice total acidity,pepsin activity, anti-oxidation system(SOD,MDA),growth factor(EGF,VEGF) and Helicobacter pylori(Hp) activity were measured to evaluate the effects;Hp was cultured and the inhibitory effect of the 2-phenyl-heptanone which extracted from galangal on Helicobacter pylori(Hp) in vitro was validated.Antibacterial screening experiments about Galangal,Cyperus rotundus,lily,and Lindera aggregata were carried out too.The results showed that Jiangbai Powder can significantly reduce the ulcer index (P＜0.05)on ethanol-induced gastric ulcer rat model,stress ulcer rat model,pyloric ligation ulcer rat model and acetic acid ulcer rat model;can significantly improve the SOD activity(P＜0.05)and reduce the MDA content(P＜0.05)of ethanol-induced gastric mouse model;can significantly improve the EGF and VEGF level of gastric tissue on Acetic acid ulcer rat model and the pepsin activity(P＜0.05) of the pyloric ligation rat model;It can also reduce the frequency of the turning trunk reaction on Acetic acid achy mouse model;Jiangbai Powder has inhibitory effect on Hp in vitro and the 2-phenyl-heptanone in vivo,which was extracted from galangal.The protection and therapeutic mechanism of Jiangbai Powder on gastric ulcer can be summarized as followings:firstly,Jiangbai Powder may enhance tissue regenerate capacity and anti-oxidation,its specific mechanism remains to be further studied; secondly,Jiangbai Powder has a certain Hp inhibitory effect and the extraction form Galangal and Lindera aggregata may be the main reason.The Jiangbai Powder is inappropriate to be made as capsules or granules for its strong spicy flavor,larger amount of oral administration.Therefore coated tablets were chosen as the suitable dosage form.The moisture absorption and disintegration time were the important problem to solve for the Jiangbai Powder is hygroscopic viscous, poor mobility after water dispersed.So the formulation and tableting procedur were abtained by selecting appropriate accessories,disintegrant and its dosage,rigidity and the best RH%.This experiment investigated the fluidity,hygroscopicity,disintegration of starch microcrystalline cellulose,dextrin,magnesium stearate,silica powder and croscarmellose sodium(CC-Na),selected microcrystalline cellulose as fillers,CC-Na as disintegrant,aerosol as glidants,the ratio of raw materials and adjuvant was 6:4;studied the impact of different dosage of CC-Na(5%,6%,7%,8%) on dissolution,7%was the best dosage;studied the impact of different adding way of disintegrant on dissolution,chose the within plus way of adjuvant;compared the impact of rigidity(7 kg,4 kg) on dissolution,opted 4 kg as the proper rigidity;Determined the moisture absorption rate of Jiangbai granules in different humidity,drawn moisture absorption curve,obtained that the critical relative humidity(CRH)was 68.5%.The formulation of the Jiangbai Tablet is 60%of raw materials,30%of fillers (microcrystalline cellules),7%of the disintegrant(croscarmellose sodium,CC-Na) and 3%of glidants(aerosol);Jiangbai powder and adjuvant were dried,mixed evenly, sieved by 80 mesh,wetted with 70%ethanol,granulated with 30 mesh then tabletted, the tablet weight is 0.4 g and rigidity is 4 kg,the CRH is controlled below 68.5%in the tabletting process.Tablets obtained in this way were met the requirements of Ch.P.2005 in appearance,rigidity,tablets weight variation and dissolution.