摘要
目的:根据国内10省份不同厂家辛伐他汀片的溶出度测定结果评价药品质量。方法:参照《日本药品品质再评价工程》,分别以水、pH 1.2盐酸溶液、pH 4.0醋酸盐缓冲液和pH 6.8磷酸盐缓冲液(均含0.5%十二烷基硫酸钠)为溶出介质,考察原研制剂与国产仿制制剂的溶出行为,采用相似因子(f_2)法,考察10种辛伐他汀片与原研制剂溶出曲线的相似性。结果:国内10省份不同厂家生产的辛伐他汀片中大部分f_2均<50,溶出曲线与原研制剂不相似。结论:国产辛伐他汀片仿制制剂与原研制剂质量存在显著差异,仿制制剂质量标准有待提高。
OBJECTIVE：To evaluate the quality of Simvastatin tablet from different manufacturers in 10 provinces by determining their dissolution. METHODS：Referring to Japan Drug Quality Reevaluation Project,water,pH 1.2 Hydrochloric acid solution,pH 4.0 Acetate buffer solution and p H 6.8 Phosphate buffer solution（containing 0.5% sodium dodecyl sulfate）were used as dissolution media to incestigate the dissolution of original and different domestic preparations,and f_2 factor method was conducted to investigate the similarity of dissolution between 10 kinds of Simvastatin tablet and original preparations. RESULTS：The f_2 of Simvastatin tablet from most of those manufacturers in 10 provinces were less than 50,and the dissolution and original preparations were dissimilar. CONCLUSIONS：The domestic Simvastatin tablet shows significant difference with original preparations,and the quality standard of generic-made need to be further improved.
出处
《中国药房》
CAS
北大核心
2016年第9期1275-1278,共4页
China Pharmacy
关键词
辛伐他汀
溶出度
相似因子
质量
Simvastatin
Dissolution
Similar factor
Quality
