论文部分内容阅读
目的:建立光纤溶出法对吲哚美辛凝胶膏剂释放度进行检测。方法:光纤溶出法使用光纤溶出仪按照中国药典桨碟法实验,以0.9%氯化钠溶液-乙醇(50∶50)为释放介质,温度为32℃,体积为900 mL,转速为100 r·min~(-1)。对各取样时间点获得的样品平行进行HPLC法测定,通过测定结果的比较来验证光纤溶出法的准确性,并通过不同工艺处方的样品依法检验来验证光纤溶出法的区分性。结果:光纤溶出法通过比较所获得的释放曲线,HPLC法与光纤溶出法释放相关性良好,而不同工艺处方的样品之间差异显著。结论:所建立的光纤溶出法准确简便,对不同工艺处方的样品也有一定的区分性。
Objective: To establish an optical fiber dissolution method for the determination of indomethacin gel ointment release. Methods: The optical fiber dissolution method was used according to the Chinese Pharmacopoeia and the method of optical fiber dissolution. The dissolution rate was 0.9% sodium chloride solution-ethanol (50:50), the temperature was 32 ℃, the volume was 900 mL and the rotational speed was 100 r · min ~ (-1). The samples obtained at each sampling time point were measured by HPLC in parallel. The accuracy of the optical fiber dissolution method was verified by the comparison of the measured results. The discrimination of the optical fiber dissolution method was verified by the sample test according to different prescriptions. Results: Compared with the release curve obtained by the optical fiber dissolution method, the correlation between the HPLC method and the optical fiber dissolution method was good, and the difference between the samples of different prescriptions was significant. Conclusion: The established optical fiber dissolution method is accurate and convenient, and it also has certain distinction on samples of different process prescriptions.