高速熔融搅拌法制备格列齐特缓释微丸

Preparation of Gliclazide sustained-release pellets by high-speed melt agglomeration

以硬脂酸、单硬脂酸甘油酯为粘合剂,高速熔融搅拌法制备格列齐特缓释微丸,考察处方与工艺因素对体外释放度的影响。结果表明,最优处方、工艺为:制丸温度53℃,粘合剂用量25%,包衣量15%,乳糖含量40%。制备的微丸圆整度好,收率高,在1,2,4,6,8 h的累积释放度分别为25%,32%,52%,65%,82%,释药行为较好,符合药典规定。

Gliclazide sustained-release pellets were prepared by high-speed melt agglomeration using stearic acid and glycerol monostearate as binder. The influence of prescription and technological factors on in vitro release was investigated. The result showed that the optimization of prescription and technological were definited： temperature of water 53 ℃,amount of binders 25% in quantity,amount of coating material15% in quantity,amount of lactose 40% in quantity. The pellets prepared had good roundness and recovery. The releasing degree of prepared pellets at 1,2,4,6,8 h were 25%,32%,52%,65%,82%. The release behavior of gliclazide sustained-release pellets is quite well,meet the requirements of Ch P.