4厂家左氧氟沙星片溶出度考察

Comparison of Dissolution Rates of Levofloxacin Tablets Produced by 4 Manufactures

目的:比较4厂家左氧氟沙星片的溶出度,为临床用药提供参考。方法:采用紫外分光光度法,分别测定4厂家左氧氟沙星片不同时间内的累积溶出百分率,并以威布尔公式计算出溶出参数T50、Td、T80、m的值,再对参数进行方差分析。结果:4厂家左氧氟沙星片溶出度均符合2000年版《中国药典》规定,但其T50、Td、T80、m值间均有显著性差异(P<0.01)。结论:有关厂家应严格按照《中国药典》规定控制产品的内在质量,以保证临床用药安全、有效。

OBJECTIVE： To compare the dissolution rates of levofloxacin tablets produced in 4 domestic pharmaceutical manufacturers in order to provide the evidence for its clinical use.METHODS： UV spectrohpotmetry was used to determine the cumulative dissolution rates of these 4 kinds of levofloxacin tablets at different time points, the dissolution parameters of T50, Td,T80,and M were calculated by Weibull formula, then variance analysis was made .RESULTS：The dissolution rates of these 4 kinds of levofloxacin tablets all met the standards recorded in 2000 edition of China Pharmacopoeia, but significant differences were found in parameters of T50, Td, T80, and M（P 〈 0.01） ,CONCLUSION： The manufacturers should strictly obey the standards recorded in China Pharmacopoeia for the quality control of the products in order to ensure the safety and efficacy of clinical drug use.