水合氯醛肠溶胶囊释放度测定方法的研究

Study on release determination method of Chloral Hydrate Enteric-coated Capsule

目的:建立水合氯醛肠溶胶囊释放度测定方法。方法:以水为释放介质,采用碘化N-乙基喹那啶为显色剂,在605 nm处测定紫外吸收并计算累计释药量。结果:该方法在1.00～9.00μg/ml浓度范围内有良好的线性关系(r=0.999 8);样品溶液在8 h内稳定,平均回收率为99.8%,RSD=0.54%,30 min累积释放度达到90%以上。结论:该法操作简便、快捷、准确,稳定可靠,可用于水合氯醛肠溶胶囊释放度的测定。

Objective：To assay method for release of the Chloral Hydrate Enteric-coated Capsule by UV.Methods：Purified water was taken as release medium and quinaldine ethiodide was taken as chromogenic agent.The release of Chloral Hydrate Enteric-coated Capsules was determined at wavelength of 605 nm.Results：In the concentration range of 1.00-9.00 μg/ml,the method owned good linearity（r=0.999 8）.The sample solution kept stable within 8 hours.The average recovery was 99.8%,RSD=0.54%,the cumulative release rate was over 90% after 30 min.Conclusion：This method is simple,convenient,accurate,stable and reliable to be used in assaying for release of the Chloral Hydrate Enteric-coated Capsule.