Study On Quality Control Of Large Variety Compound Biejia Ruangan Tablets

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, efc[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.ObjectiveUse the production process quality control management concept "raw material-intermediate-end product" to study CBRT and establish a better quality control mode of CBRT.Methods① 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 condensation temperature and the range of volatile component were defined.③ The contents of paeoniflorin, phillyrin, ginsenoside Rgi and adenosine of ten batches of CBRT were determined at different times. The self-defined weighting coefficient based on the contents has been created to establish the integral dissolution model. In addition, the biological potency of CBRT was measured by MTT assay. Then, the f2 similar factor was used to evaluate the similarity of integral dissolution and biological dissolution.Results① 200 mesh of Carapax Trionycis sample from Shangcheng, Henan is the best.② From our studies, volatile component was phillyrin. The condensation temperature and content of phillyrin was 60℃ and 0.738～1.371 mg/g.③ The integral dissolution based on biological test of CBRT was demonstrated that it may be a promising supplement for CBRT quality evaluation.ConclutionsFrom the experimental results of Carapax Trionycis, volatile component and CBRT, we could obtain the effect of Chinese medicine can be influenced by regions and particle sizes. The content of volatile component could monitor the end product quality. The integral dissolution can be a promising supplement for CBRT quality evaluation.