Study On Quality And Formula And Preparation Technology Of Gliclazide Sustained-release Tablets

Objective Launched in 2001, the French servier company specifications 30 mg of gliclazide zyban(gliclazide sustained- release tablets) to enter the market, in 2003 after entering our country, research and development of domestic production enterprises, has been used for 10 years. French servier now launched specifications 60 mg of gliclazide zyban, intended for intensive diabetes patients, reduce the number of patients with drug use, to reduce the incidence of adverse reactions, and improve the medication compliance of patients, so as to achieve a better therapeutic effect. Now the preparation specifications has not yet come into our market. For the convenience of patients with drug use in our country, to overcome the high cost of imported drugs,reduce the economic burden of patients, this topic proposed for specification of 60 mg gliclazide zyban to beat, provide resources for domestic drug manufacturing enterprises.Methods With French servier company 30 mg specifications of gliclazide zyban for reference preparations, using hydroxypropyl methyl cellulose K30 M as skeleton material, in vitro release as examining index, optimizing domestic zyban accessories,with orthogonal experiment to optimize the prescription, to establish the determination method of in vitro, the degree of the products and content determination etc., and the stability of the products.Results Character determines the homemade columns together, the best prescriptionand preparation technology, in the process of homemade, since the products appearance, content and in vitro release of the index is not obvious difference with reference preparations, quality control.Conclusion: Optimization of gliclazide zyban(60mg/tablet) prescription is reasonable, the technology is feasible, reliable quality, good stability, low cost, the data can provide reference for domestic production enterprises.