| Objective: Biological Liuwei has combined classical Traditional ChineseMedicine（TCM）Liuwei Dihuangtang and Photosynthetic Bacteria organically.Withthe changing of substantial foundation caused by Photosynthetic Bacteriametabolism,its pharmacological effects has also changed.Study showed thatBiological Liuwei is better than classical Liuwei Dihuangtang on the aspect of anti-aging.In order to improve the stability of this medicine and satisfy modernrequirement of drug using,we’ll extract Biological Liuwei’s effectivecomponents,develop a new TCM film-coated tablet with the extact and formulate thequality standard draft of the film-coating tablet.Methods:①The preparation of Biological Liuwei: Prepared Biological Liuweiwith the using of ready-made technology as crude material;②Establishment ofanalytic method: Investigated methodology combined with modern chemical andinstrumental technology such as TLC,UV visible spectrophotometry,HPLC,etc.③Study of extraction technology: Optimized the extraction method of BiologicalLiuwei’s effective components by means of orthogonal experiment,and investigatedoptimal technological condition for eliminating residual n-Butyl Alcohol.④Study oftablet’s preparation technology: Investigated the prescription of tablet core, qualityof semi-finished products and condition of tablet pressing,then investigated thetechnological parameters of film-coating.⑤Study of quality standard: Researchedthe quality standard of preparation with reference of related rule in the《ChinesePharmacopoeia(2010)》.⑥Study of preliminary stability experiment: Examinedimportant parameters of film-coated tablet during high temperature, high humidityand high light experiment, as well as acceleration experiment and long-term experiment.Results:①Systematical analytic methods has been established and it providedreliable accordance for later quantitative and qualitative analysis;②Optimalextraction technology of Biological Liuwei’s effective components was: Five times of95%ethanol added into Biological Liuwei.The ethanol soluble part of the mixture wasconcentrated and extracted three times with24hour at every time by the same volumeof Petroleum Ether,Ethyl Acetoacetate respectively; And determined optimaltechnique conditions for eliminating residual n-Butyl Alcohol;③The prescriptiondesign was:40%of Biological Liuwei’s effective components,50.5%ofMicrocrystalline Cellulose(MCC),5%of Crospovieone (PVPP) was added beforemaking powder and4%of Carboxymethylstach Sodium(CMS-Na) was added afterreshaping powder,the appropriate amount of5%PVP K-30absolute ethanolsolution,0.5%of Magnesium Stearate（MS）;The relative humidity of environmentshould been lower than75.3%during storage and transportation;④Optimaltechnology parameters of film coating was: the temperature of air inlet was50℃;Therotation speed of Film coating machine was40~50rpm, Atomization velocity was2~3mL/min and atomization pressure was2~3bar,Curing time was nine hour;⑤Detection method of important indices such as appearance, tablet weightdifference,disintegration time limit was formulated.And quality standard draft wasprotocoled.⑥The result of preliminary stability experiment shows that importantdetection indices of Biological Liuwei’s effective components tablet was not changedsignificantly under the condition of high temperature,high humidity and high light indefinite range.And the preparation was stable during acceleration experiment andlong-term experiment.Conclusion： The formation techniques of Biological Liuwei’s effectivecomponents tablet was stable and the quality detection method is reliable.The Biological Liuwei’s effective components, which had significant anti-agingeffective,was developed into a TCM film-coated tablet.On the one hand,it has solvedproblems such as the extract powder has high viscosity and stronghygroscopicity,etc.On the other hand,it’ll benefit the compliance of drug use.So thisstudy has provided important reference for the research and production of new TCMpreparation. |
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