中国临床药学杂志

目的建立维生素C微丸缓释胶囊体外释放度检测方法,评价其体外释放特性。方法以0.01 mol·L^-1盐酸-0.03%乙二胺四乙酸二钠-0.05%L-半胱氨酸溶液为释放介质,介质体积为1 000mL,转速为50 r·min^-1,采用紫外-可见分光光度法于243 nm波长处测定吸光度,转篮法评价体外释放特性。结果维生素C质量浓度在1.028～1 2.336 mg·L^-1内与其吸收度之间呈良好线性关系(r=0.9999);平均回收率为99.56%,RSD为0.86%。结论维生素C微丸缓释胶囊具有较好的释药性能和良好的缓释效果,符合《中国药典》要求。

AIM To establish a method of in vitro release rate on sustained-release capsules of vitamin C pellets and characterize their release behavior.METHODS The medium was 0.01 mol·L^-1 hydrochloride solution and 0.03% disodium EDTA and 0.05%L-cysteine;the volume was 1 000 mL;the rotation speed was 50 r·min^-1 and the absorbability was determined at 243 nm by ultraviolet-visible(UV) spectrophotometry.Rotate-basket method was employed to evaluate its in vitro release efficiency.RESULTS Vitamin C concentration in the 1.028-12.336 mg·L^-1 showed a good linear relationship with its absorbability(r=0.999 9).The average recovery was 99.56%,and RSD was 0.86%. CONCLUSION According to the Chinese pharmacopoeia standards,sustained-release capsules of vitamin C pellets have a better performance and a good sustained-release efficiency.