盐酸青藤碱控释微丸的制备及含量测定

Preparation and assay of sinomenine hydrochloride controlled-release pellets

目的制备盐酸青藤碱控释微丸,并为溶出度的测定建立体外含量测定方法。方法采用膜控技术,离心造粒法制备盐酸青藤碱控释微丸。采用紫外分光光度法进行含量测定。结果盐酸青藤碱在10～80μg/ml范围内线性相关性良好,C=66.7A+0.002,r=0.9999,精密度和回收率均符合中国药典2005版的规定。结论微丸的表面光滑圆整,含量测定方法快速、准确、重现性好,可用于该制剂溶出度的测定。

Objective To prepare sinomenine hydrochloride controlled-release pellets and establish an in vitro assay for percent dissolution of the pellets. Methods Membrane controlled-release technique and centrifugal coating pelletization were used to prepare sinomenine hydrochloride controlled release pellets. UV spectrophotometry was used to determine the percent dissolution of the preparation. Results Sinomenine hydrochloride showed good linear correlation within a concentration range of 10-80 μg/mL （C=66.7A＋0.002,r=0.9999）. Average recovery rate and precision degree of the method met the requirements of Chinese Pharmacopoeia 2005. Conclusion The pellets has smooth surface. The UV spectrophotometry used for determining percent dissolution of the preparation yielded quick ,accurate and reproducible results.