目的 探讨栀子总苷缓释片多组分体外释放度评价方法。方法 采用转篮法测定释放度，HPLC法测定羟异栀子苷、京尼平龙胆二糖苷、栀子苷的释放速率，UV法测定栀子总苷释放速率，采用相似因子法和释放机制评价多组分释放的同步性。结果 羟异栀子苷、京尼平龙胆二糖苷、栀子总苷与栀子苷释放速率相近，与栀子苷释放度的相似因子分别为81%、72%、91%，释放机制均符合Higuchi方程，说明栀子总苷缓释片多组分是均衡释放的。结论 本法可用于栀子总苷缓释片多组分体外释放度评价。

Objective To explore the evaluation method for in vitro release of multi component in Gardenia Total Glycosides Sustained-release Tablets. Methods Rotating basket method was carried out to determine the release rate. HPLC method was employed to assess the release rate of gardenoside, genipingeniobioside, and geniposide, and UV method was used to determine the total glycosides. Results The release rates of gardenoside, genipingeniobioside, geniposide, and total glycosides were similar. Similarity factors were 81%, 72%, and 91%. The data of cumulative release rate fitted best with Higuchi model. The release of Gardenia Total Glycosides Sustained-release Tablets had a well-balanced release behavior. Conclusion Quality of multi-components in Gardenia Total Glycosides Sustained-release Tablets can be controlled effectively by the method.

国家重点基础研究发展计划（973计划）项目（2012CB724001）