论文部分内容阅读
目的:考察不同厂家缬沙坦胶囊体外溶出度曲线,比较不同厂家药品的内在质量,为药品质量控制和临床用药提供参考。方法:用光纤传感过程分析技术监测4个厂家缬沙坦胶囊在pH 6.8,pH 4.5,pH 1.2及水4种溶出介质的溶出过程。采用f2因子法对溶出曲线的相似性进行评价。结果:4个厂家缬沙坦胶囊在pH 6.8磷酸盐缓冲液中30 min时溶出度均大于80%符合药典规定,但溶出曲线差异很大;在其他3种介质中的溶出度偏低且存在较大差异;比较结果说明不同药厂缬沙坦胶囊的质量存在显著性差异。结论:采用FODT法过程分析检测固体制剂的溶出曲线比单点溶出度测定更能直观反映不同厂家制剂工艺、均匀度和药品质量的差异。对不同来源的相同制剂考察不同溶出介质的溶出曲线是非常有必要的。
OBJECTIVE: To investigate the in vitro dissolution profiles of valsartan capsules from different manufacturers and to compare the intrinsic qualities of drugs from different manufacturers so as to provide reference for the quality control and clinical medication of drugs. Methods: The dissolution process of four manufacturers of valsartan capsules at pH 6.8, pH 4.5, pH 1.2 and water was monitored by optical fiber sensing process analysis. The f2 factor method was used to evaluate the similarity of dissolution curves. Results: The dissolution rates of valsartan capsules in pH 6.8 phosphate buffer solution at 30 min were all above 80%, which were in accordance with the regulations of Pharmacopoeia, but the dissolution curves were quite different. The dissolution rate in the other three media was low and existed The results showed that there were significant differences in the quality of valsartan capsules between different pharmaceutical companies. Conclusion: The dissolution curve of the solid preparation by FODT method is more intuitive than the single-point dissolution method to reflect the differences of preparation, uniformity and drug quality of different manufacturers. It is necessary to investigate the dissolution profiles of different dissolution media for the same formulation from different sources.