| Liuweiwuling tablet, which is approved for sale in2006falls into the category of three kinds of traditional Chinese medicine. With the function of nourishing the kidney and liver and invigorating the circulation of the role of detoxification, it is commonly used in clinical treatment of chronic hepatitis B and won the title of" The Third Top10Influential Brand in Liver kind medicine market in China ". It is a processed traditional Chinese medicine (TCM) which contains schisandrae chinensis fructus, forsythiae furcus, ligustrilucidi furcus, curcuma zedoary, sonchus brachyotus and ganoderma lucidum. Content item in the original drug registration standard only contains eoxyschizandrin determination to the complexity of Chinese herbalmedicinal ingredient s and mechanism of action, the single component content determination is difficult to fully reflect the quality of medicine. With a view to improve the quality control, enhance market competitiveness, in this thesis the improvement of the breed quality standard were studied.On the basis of summarizing the literature research, and ingredients composition and function analysis of Liuweiwuling tablet, In this thesis I choose the the five guideposts of phillyrin, schisandrin, Schisantherin A, eoxyschizandrin and schisandrin, and test the content determination of five components adopting high performance liquid chromatography (HPLC) method with its advantages of high pressure, high efficiency, high speed, high sensitivity, wide applicable scope.For full control of product quality at the same time, I use the fingerprint technology which is currently widely accepted for its rich information and reflection of the overall performance of the Chinese traditional medicine ingredients to carry out the HPLC fingerprint method study on Liuweiwuling tablet.1. This thesis measured the five main active ingredient of phillyrin, schisandrin, Schisantherin A, eoxyschizandrin and schisandrin of Liuweiwuling tablet,with high performance liquid chromatography (HPLC) method, using AgilentZorbaxSB-C18 column and1%acetonitrile-phosphate solution as mobile phase gradient elution, detection wavelength of230nm.Experimental results showed that5kinds of index component separation is good; its linearity, precision, stability, repeatability and recovery are also good;20samples of five component content is stable and there is no significant difference.2. This thesis studied and established the HPLC fingerprint method of Liuweiwuling tablet, with high performance liquid chromatography (HPLC) method,using AgilentZorbaxSB-C18column and1%acetonitrile-phosphate solution as mobile phase gradient elution, detection wavelength of230nm.The experiment produced a total of25common peaks, and illuminated the source of common peaks and part of chromatographic peak qualitatively. Fingerprint of20batches of samples generated are of high similarity and smaller difference.3. This thesis gives the long term stability test of the samples and investigates the content of5kinds of indexes of composition and their fingerprint matching. The experiment shows that three batches of samples for5kinds of component content determination results and fingerprint matching have no obvious change, thus it proves that the measuring method of the content and the fingerprint method has good feasibility.With the component content determination and fingerprint study on Liuweiwuling tablet, this thesis provides the reference and technical support to improve the product quality standard and comprehensive control of product quality which can improve product quality, enhance the competitiveness of enterprises and guarantee the drug’s safety and effectiveness. |
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