| Objective:to establish a methods of extraction process online testing of ZhongSheng pill, lay a foundation for process control of all links in ZhongSheng pill production process, ensure the controllability and stability of the product quality.Methods:1. Quality control(QC) of crude drugs:to identify the variety and determinate the content of each crude drugs of ZhongSheng pill according to the Chinese Pharmacopoeia(2005 Version)2. Technical study of extraction process:According to the characteristics and function of effective constituent in ZhongSheng pill, we determine to choose Caffeicacid, Paeoniflorin, Polydatin and Baicalin as measurement indicators. Influence of preprocessor, extracting volume, extracting temperature, extractive heated, rate of heating and extraction process"dynamic"on extraction process was investigated to find marker components which can represent other effective constituent during the extract process, and to determine the most significant factors which can influence the content of marker components.3. Research on on-line detecting methods:using UV absorption spectrum as a means of on-line detection, Baicalin as control index, to get the best laboratorial extraction process. By processing the spectral data, we set up a model of on-line detecting method which is regarding the UV absorption spectrum of various laboratorial extract situation as standard reference data, determine the trend change in the extraction process and production situation(including abnormal condition), instruct production.Results:1. Result of quality control(QC) of crude drugsAll of the crude drugs of ZhongSheng pill are involved in the Chinese Pharmacopoeia(2005 Version), we carry out quality control in accordance with the law and the results are accepted with correlative request.2. Technical study of extraction process2.1 Research on preprocessor:We observed the mesh narrow effect of main crude drugs of ZhongSheng pill, the results shows the extraction efficiency of Taraxacum and Red Paeony Root can reach 85% without treatment, therefore these two kins of medicinal extract directly. While Baical Skullcap Root and Polygonum cuspidatum Sieb. et Zucc can reach a higher extraction efficiency when plane into woodflour.2.2 Research on extracting volume:the results shows that the best extraction process is ten times volume of solvent.2.3 Research on extracting temperature:Baical Skullcap Root and Polygonum cuspidatum Sieb. et Zucc extraction temperature effect is the most obvious, they need higher temperature to extract while Taraxacum and Red Paeony Root can be extract under lower temperature.2.4 Research on extractive heated:After a period of time putting in high-temperature place, the content of caffeicacid in the extractive declined, it indicate that caffeicacid is the most sensitive one to temperature among Caffeicacid, Paeoniflorin, Polydatin and Baicalin, long time under high temperature can make caffeicacid degradation..2.5 Research on rate of heating:Results shows that the faster it heated the faster and more completely of effective components extraction, especially for Baical Skullcap Root and Polygonum cuspidatum Sieb. et Zucc, the extraction efficiency of these two medicinal materials grow obviously with the rate of heating.2.6 Research on extraction process"dynamic":Extraction process"dynamic"can improve the extraction efficiency of all effective components, prevent herbal accumulation during the process of extraction.3. Research on on-line detecting methodsSet up a UV test methods of on-line detecting on the content of baicalin of ZhongSheng pill. Using this method can we monitor extractive online by UV-Vis absorption, calculate the content of marker component by spectra data, component content changes reflect the actual situation in the process of extracting. We simulate real extraction process in the laboratory (including various of abnormal conditions) and set up on-line testing model according to each process parameter index content changes feedback. Using this model can we judge the production trend via spectra data, adjust production process in time. and realize on-line detecting in extraction process.Conclusion:The extraction process on-line detecting methods of ZhongSheng pill was able to give a real time monitoring to the content change of baicalin during the production, ensure product quality.
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