不同厂家克拉霉素缓释片溶出度考察

Comparison of Dissolutions of Clarithromycin Sustained Release Tablets in Vitro Coming from Different Pharmaceutical Factories

目的:考察不同厂家的克拉霉素缓释片体外溶出度,为药品采购及临床选用药物提供参考。方法:采用转篮法进行体外溶出度实验,并用高效液相色谱法测定克拉霉素缓释片溶出含量,计算累积溶出百分率;以威布尔方程(Weibull's equation)拟合溶出参数t_(50)、t_d、t_(80)、m,再对参数进行方差分析。结果:3家生产厂的克拉霉素缓释片体外溶出参数t_(50)、t_d、t_(80)、m,经比较其差异有统计学意义(P<0.01)。结论:不同厂家生产的克拉霉素缓释片溶出度存在显著差异,采购药品及临床用药时应加以注意。

Objective： To study the dissolutions of clarithromycin sustained release tablets from different manufacturers in vitro and to provide a reference for drug purchase and clinical use of drugs. Methods：The dissolution test was carried out by basket method. The concentration of clarithromycin was measured by HPLC. The accumulative dissolution was calculated and the Weibull＇s equation was used to model the dissolution parameters. The difference between different groups was statistically evaluated by variance analysis. Results ： Significant difference was found in clarithromycin sustained release tablets coming from three manufacturers in dissolution parameters t50, td, t80, m（P〈0.01）. Conclusion ： There were significant differences in dissolution parameters in the clarithromycin sustained release tablets coming from different manufacturers. It was indicated that attention should be paid to drug purchase and clinical applications.