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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 explore the feasibility of combined chromatography and UV for the evaluation of in vitro dissolution of traditional Chinese medicine preparations. Methods: 0.1mol.L-1HCL as the release medium, Xiao Chai Hu tablet for the study, according to “Chinese Pharmacopoeia” 2005 edition determination of the dissolution rate of the preparation in vitro, measured by UV absorption of the release liquid at 272 nm, determined by HPLC Baicalin content. The UV absorbing component of the release liquid is decomposed into two components, the specific component (baicalin) and non-specific components (excluding baicalin). Results: HPLC can reflect the dissolution of the baicalin, a specific ingredient. By deducting the UV absorbance of baicalin in the release solution, UV can be used to describe the dissolution of nonspecific ingredients. Conclusion: Combined chromatography and UV can be better evaluated in vitro dissolution of Chinese medicine formulations.