大品种复方鳖甲软肝片的质量控制研究-中药学专业论文.docx

万方数据 万方数据 0.738~1.371 mg/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 ABSTRACT Quality control and evaluation is the key scientific problems of modernization, hotspot and difficulty in the study of Traditional Chinese medicine (TCM)[1,2]. Key tasks during China’s 12th Five-Year Plan would focus on the development of the components of Chinese herbal medicine (CHM), clearing the foundation of pharmacodynamic substance and promoting quality standard. Based on our present study of quality control of CHM, medical workers has put many innovative ways to build and improve the quality standards of CHM, such as diversified quality control and evaluation and biological potency, etc[3,4]. FDA put forward Current Good Manufacturing Practices (2002) and Process Analytical Technology (2004)[5]. Medical workers can find, “pharmaceutical companies should strengthen the understanding and control of raw materials, intermediates and critical quality and performance characteristics of processes. Only in this way can we ensure the quality of end product.” Meanwhile, we put forward production process quality control management concept “raw material- intermediate- end product”. And use the concept to study Compound Biejia Ruangan Tablet (CBRT) and establish a better quality control mode of CBRT. Objective Use the production process quality control management concept “raw material- intermediate-end product” to study CBRT and establish a better quality control mode of CBRT. Methods ① The samples from different regions and particle sizes were determined with the HPLC method. Use the LX-2 hepatic stellate cells as a hepatic fibrosis model to determine the anti-fibrotic of Carapax Trionycis. Then, the best region and particle size of Carapax Trionycis was cleared. ② The contents of volatile components which were condensed by different temperatures were determined with the HPLC method. The con