目的 探討梔子總苷緩釋片多組分體外釋放度評價方法。方法 采用轉(zhuǎn)籃法測定釋放度，HPLC法測定羥異梔子苷、京尼平龍膽二糖苷、梔子苷的釋放速率，UV法測定梔子總苷釋放速率，采用相似因子法和釋放機制評價多組分釋放的同步性。結(jié)果 羥異梔子苷、京尼平龍膽二糖苷、梔子總苷與梔子苷釋放速率相近，與梔子苷釋放度的相似因子分別為81%、72%、91%，釋放機制均符合Higuchi方程，說明梔子總苷緩釋片多組分是均衡釋放的。結(jié)論 本法可用于梔子總苷緩釋片多組分體外釋放度評價。

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.

國家重點基礎(chǔ)研究發(fā)展計劃（973計劃）項目（2012CB724001）