盐酸二甲双胍缓释片释放度的比较

目的制备盐酸二甲双胍缓释片，并与国外相同缓释片的释放度进行比较。方法以HPMC（K4M）和CMC-Na为缓释材料制备盐酸二甲双胍缓释片，采用相似因子法对实验室自制的和国外进口的盐酸二甲双胍缓释片的释放度进行考察。结果自制缓释片和进口缓释片1h的累计释放百分率分别为27．71％±0．97％和25．30％±2．03％，6h的累计释放百分率分别为67．47％±1．45％和70．34％±1．17％，12h的累计释放百分率分均大于85％；两种样品释放曲线的f2为（84．18±4．67）。结论自制的缓释片具有12h缓释效果；两种制剂的缓释曲线经相似因子法f2比较不存在显著性差异。

Study on the release rate of s-release tablets in vitro

Aim To prepare the sustained-release tablets, and evaluate the vitro release rate of the sustained-release tablets compared with the imported tablets. Method In this study, the metformin hydrochloride sustained-release tablets were formulated with hydroxypropyl methylcellulose （HPMC） and sodium earboxymethyl cellulose （CMC-Na） by wet granulation technique, and the vitro release rate of the two sustained-release tablets were studied by similarity factor. Results The accumulation vitro release rate of the reference sus- tained-release tablets in 1 h,6 h were 27. 71% ±0. 97% ,67.47% ± 1.45% ,and 5,30% ±2.03% ,70.34% ± 1.17% for the imported tablets. The accumulation vitro release rate in 12h were over 85% for the two tablets. The f2 for the two tablets was 84.18±4.67. Conclusion The results showed that the metformin hydrochloride sustained-release tablets were able to maintain sustained release for 12 h; The vitro release behaviors were equivalent evaluated by similarity factor.