摘要
目的采用四甲基偶氮唑盐(MTT)比色法从细胞增殖角度、结合高效液相色谱法(HPLC),探讨生物方法评价中药固体制剂体外溶出度的可行性,旨在弥补单纯化学方法难以客观反映中药固体制剂溶出度检测的不足。方法以复方鳖甲软肝片为模型药,考察在pH 7.4 PBS溶出介质中,不同溶出时间的复方鳖甲软肝片溶出液对LX-2肝星状细胞的抑制作用,提出基于细胞抑制率所得复方鳖甲软肝片的累积溶出度,结合HPLC测定芍药苷指标成分所得溶出度,运用f2相似因子法进行相关性评价。结果 f2相似因子小于50,表明单纯化学方法所测的指标成分溶出度不能等同于全方的生物效价。结论生物方法有望成为评价中药固体制剂体外溶出度的手段之一。
OBJECTIVE To explore the new pattern of Chinese medicine solid preparations （CMSP） in vitro dissolution, a meth- od testing the cell inhibition rate in combination with HPLC was used. METHODS MTF assay was used to obtain the characteristic cell inhibition rate by Fufangbiejiaruangan tablet dissolving solutions at the pH 7.4 （ phosphate buffer） dissolution medium at different times. From these results, the cumulative dissolution of Fufangbiejiaruangan tablets based on cell inhibition rate was obtained. The dis- solution rate of paeoniflorin was determined by HPLC method. Then f2 similar factor method was used to evaluate the relevance of these two methods. RESULTS f2 values was less than 50, indicating that there is a poor correlation between the two methods of measuring the dissolution rate. It is unfeasible to determine CMSP in vitro dissolution just by using paeoniflorin cumulative dissolution. CON- CLUSION Biological testing is expected to become CMSP in vitro dissolution of one of the evaluation tools.
出处
《中国药学杂志》
CAS
CSCD
北大核心
2013年第23期2018-2021,共4页
Chinese Pharmaceutical Journal
基金
国家新药创制重大专项(2011ZX09201-201-14
2011ZX09201-201-35)
国家自然科学基金资助项目(81073069)
