大品种复方鳖甲软肝片的质量控制研究.pdfVIP

0.738~1.371mg/g。 ③ 整合溶出度能更好地表征中药复方整体的溶出情况。 结论 原料的产地以及粉碎粒度对其药效存在一定的影响；中间品波动范围的规定 对全程监控成品质量有一定的辅助作用；复方鳖甲软肝片质量可通过多成分整合 溶出度进行一致性评价。 关键词：复方鳖甲软肝片；过程分析技术；生物效价；抗肝纤维化 II 万方数据 ABSTRACT Quality contro and evaluation is the key scientificproblems of modernization, [1,2] hotspot and difficulty in the study of Traditiona Chinese medicine (TCM) . Key th tasks during China’s 12 Five-Year Plan would focus on the development of the components of Chinese herba medicine (CHM), clearing the foundation of pharmacodynamic substance and promoting quality standard. Based on our present studyof quality contro of CHM,medica workers has put many innovativeways to build and improvethe quality standards of CHM, such as diversified quality contro [3,4] andevaluationandbiologica potency,etc . FDA put forward Current Good Manufacturing Practices (2002) and Process [5] Analytica Technology (2004) . Medica workers can find, “pharmaceutica companies should strengthen the understanding and contro of raw materials, intermediates and critica quality andperformance characteristics ofprocesses. Only in this way can we ensure the quality of end product.” Meanwhile, we put forward production process quality contro management concept “raw material- intermediate- endproduct”.AndusetheconcepttostudyCompoundBiejiaRuanganTablet(CBRT) andestablishabetterqualitycontro modeofCBRT. Objective Use the production proc