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栀子总苷缓释片多组分体外释放度研究
引用本文:闫光军,李守信,刘武占,苏瑞强,张则平,赵志全.栀子总苷缓释片多组分体外释放度研究[J].国外医药(植物药分册),2014(5):485-488.
作者姓名:闫光军  李守信  刘武占  苏瑞强  张则平  赵志全
作者单位:鲁南制药集团股份有限公司;中药制药共性技术国家重点实验室;山东省中药制药新技术重点实验室;
基金项目:国家重点基础研究发展计划(973计划)项目(2012CB724001)
摘    要: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。

关 键 词:栀子总苷缓释片  羟异栀子苷  京尼平龙胆二糖苷  栀子苷  释放度

Release of multi-components in GardeniaTotal Glycosides Sustained-release Tablets in vitro
Authors:Yan Guang-jun  LI Shou-xin  Liu Wu-zhan  SU Rui-qiang  ZHANG Ze-ping  ZHAO Zhi-quan
Institution:1. Lunan Pharmaceutical Group Co., Ltd., Linyi 276006, China 2. State Key Laboratory of Generic Manufacture Technology of Chinese Traditional Medicine, Linyi 276006, China 3. Shandong Provincial Key Laboratory of New Manufacture Technology ofTCM, Linyi 276006, China)
Abstract: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.
Keywords:GardeniaTotal Glycosides Sustained-release Tablets  gardenoside  genipingeniobioside  geniposide  release
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