目的建立罗通定缓释片体外释放度测定方法,评价其体外释药行为。方法用紫外分光光度法和体外释放度试验,考察罗通定缓释片在不同释放介质中和不同释放时间的累积释放度。结果罗通定在281nm处有最大吸收,在5~250μg/ml内与吸收度呈良好的线性关系:Y=0.0143X+0.0378,r=0.9999。罗通定缓释片在人工胃液中的体外释药行为理想,符合Higuchi方程:Mt/M∞=0.3933t^1/2-0.2274,r=0.9992。结论本法简便、快速,适用于罗通定缓释片的质量控制。
Objective To establish a UV method to determine the release degree of rotundine sustained-release tablets and to evaluate its in-vitro release behavior. Methods Ultraviolet speetrophotometry was applied to determine the release degree of rotundine sustained-release tablets with different release mediums. Results Rotundine had the highest absorptive peak at 281 nm mavelenth and a good linearity in the range of 5 - 250μg/ml ( Y = 0. 0143X + 0. 0378, r = 0.9999). Rotundine sustained-release tablets had a good release behavior in gastric juice, which fits the Higuchi Square : Mt/M∞ = 0. 3933t^1/2 - 0.2274, r = 0. 9992. Conclusion This method is simple, rapid, and can be used for the quality control of rotundine sustained-release tablets.