论文部分内容阅读
目的:测定正大青春宝药业有限公司(A)、德国拜耳公司(B)、天津市中央制药厂(C)、丽珠集团丽珠制药厂(D)、上海信谊药厂(E)、广东省制药工业公司华南制药厂(F)、上海世康特制药有限公司(G)、海南省普利制药厂(H)生产尼莫地平片/胶囊溶出度。方法:按部颁标准[WSl-(X-100)-95Z](以15％乙醇为溶出介质)测定尼莫地平溶出度。结果:各药厂产品的体外溶出百分率与时间关系均符合成布尔分布函数方程,其中A、B、C、D4厂家生产尼莫地平片溶出均符合部颁标准规定的溶出限度。将国内7个厂家的产品与德国拜耳公司生产的尼莫通片体外溶出参数分别进行t检验分析:C、D、E3厂与B厂产品的T_(50)、T_d之间无显著性差异(P>0.05);A、F、G、H4厂与B厂产品的T_(50)、T_d有极显著性差异(P<0.01),其中A厂产品释药明显较B厂快,而F、C、H3厂产品的释药明显比B厂慢。结论:正大青春宝药业有限公司的尼莫地平片体外溶出度已达到国内先进水平。
OBJECTIVE: To determine whether Chia Tai Qingchunbao Pharmaceutical Co., Ltd. (A), Germany Bayer (B), Tianjin Central Pharmaceutical Factory (C), Livzon Pharmaceutical Group (L), Shanghai Xinyi Pharmaceutical Factory (E) South China Pharmaceutical Factory of Guangdong Pharmaceutical Industry Company (F), Shanghai Shikang Te Pharmaceutical Co., Ltd. (G), Hainan Puli Pharmaceutical Factory (H) Production of nimodipine tablets / capsules. Methods: The dissolution standard of nimodipine was determined according to the ministerial standard [WSl- (X-100) -95Z] (15% ethanol as dissolution medium). Results: The percentages of in vitro dissolution of various pharmaceutical products were in accordance with the distribution function of Cheng Bourd. The dissolution of nimodipine tablets produced by manufacturers A, B, C, and D4 all met the dissolution limits prescribed by the Ministry of Standards. The t-test analysis of in vitro dissolution parameters of 7 domestic manufacturers and Nimotong tablets produced by Bayer in Germany showed no significant difference between T_ (50) and T_d of products C, D, E3 and B P <0.05). There was a significant difference (P <0.01) between T_ (50) and T_d of A, F, G, H4 and B plants, C, H3 factory product release significantly slower than the B plant. Conclusion: The dissolution rate of nimodipine tablets of Chia Tai Qingchunbao Pharmaceutical Co., Ltd. has reached the advanced level in China.