摘要
目的：考察盐酸二甲双胍缓释片体外释放影响因素，建立其释放度测定方法。方法：采用UV法测定盐酸二甲双胍缓释片在不同溶出递质、不同方法和不同转速的释放度。结果：UV法测定盐酸二甲双胍缓释片释放度线性关系良好，r=0．9999（n=5），线性范围为2～10mg·L^-1，回收率和稳定性均良好。药物释放受释放方法和递质的影响。盐酸二甲双胍缓释片体外释放曲线在t=0～12h范围内较符合一级动力学方程。结论：方法简便，结果可靠，可作为盐酸二甲双胍缓释制剂生产过程的质量控制依据。
OBJECTIVE To study the factors effecting the releasing rate of metformin hydrochloride sustained-release tablets and establish a determination method for the releasing rate, METHODS The releasing rate of metformin hydrochloride sustained-release tablets was determined by UV in different conditions. RESULTS The calibration curve was linear over the range of 2 - 10 mg·L^-1. The recovery and the stability were good, Drug release was influenced by the method and the release medium. The release profile of metformin hydroehloride sustained-release tablets followed first order processes better over the range of t = 0 - 12 h. CONCLUSION The method is simple and results are reliable. It can be used for quality control.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2006年第4期409-412,共4页
Chinese Journal of Hospital Pharmacy
关键词
盐酸二甲双胍
缓释片
释放度
releasing rate
metformin hydroehloride
sustained release tablets
