联合色谱法和UV评价中药制剂体外溶出度

Investigation of Determination and Evaluation for in vitro Dissolution of Chinese Medicine Preparations by Co-Chromatography and UV

目的:探讨联合色谱法和UV用于评价中药制剂体外溶出度的可行性。方法:以0.1 mol.L-1HCL为释放介质,小柴胡片为研究对象,按《中国药典》2005年版测定该制剂的体外溶出度,采用UV测定释放液在272 nm处吸收度,通过HPLC测定黄芩苷含量。释放液的UV吸收成分被分解为特定成分(黄芩苷)和非特定成分(除黄芩苷外的成分)两部分。结果:HPLC可反映特定成分黄芩苷的溶出度;通过扣除释放液中黄芩苷的UV吸收值,UV可用于描述非特定成分的溶出度。结论:联合色谱法和UV可较好地评价中药制剂的体外溶出度。

Objective： To investigate feasibility of UV and co-chromatography for evaluating in vitro dissolution of Chinese medicine preparations. Method： With 0.1 mol·L-1 hydrochloric acid as release medium,in vitro dissolution of Xiaochaihu tablets was determined according to the 2005 edition of ＇Chinese Pharmacopoeia＇,absorbance of release solution at 272 nm was determined by UV,the content of baicaline was determined by HPLC.UV absorption ingredients of this solution were divided into two parts—the defined ingredient （baicaline） and the undefined ingredients （other ingredients）. Result： HPLC could reflect dissolution of baicaline（the defined ingredient）;UV could describe dissolution of other ingredients through deducting UV absorption of baicaline from release solution. Conclusion： In vitro dissolution of Chinese medicine preparations could be better measured and assessed by co-chromatography and UV.