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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。
OBJECTIVE To establish a method for the in vitro release of vitamin C pellets and evaluate its in vitro release characteristics. Methods 0.01mol·L -1 hydrochloric acid -0.03% disodium edetate -0.05% L-cysteine solution as the release medium, medium volume 1000mL, speed 50r · min ~ ( -1). The absorbance was measured at a wavelength of 243 nm by UV-Vis spectrophotometry, and the spinach method was used to evaluate the in vitro release characteristics. Results There was a good linear relationship between the concentration of vitamin C and its absorption in the range of 1.028-1.2336 mg · L -1 (r = 0.9999). The average recovery was 99.56% and the RSD was 0.86%. Conclusion Vitamin C pellets sustained-release capsules have good release properties and good sustained-release effect, in line with the “Chinese Pharmacopoeia” requirements.