Study On Quality Control And Optimization Of Extraction Process For Xinshen Ning Tablets

Xinshen Ning Tablets consist of Ziziphi spinosae semen,Gardeniae fructus,Polygalae radix,Poria,Glycyrrhizae radix et rhizome and so on.It can reinforce the liver blood,healthy the spirit of heart,clear heat and relieve fidgetness, filling with heart-liver blood deficiency,dreaminess,irritability,irritability and eating less. Except that, it has an effect on the neurasthenia,anxiety and assoiciated symptoms significantiy.Both sedation,but nourish dffort, solve the problem from the inside into out.Xinshen Ning Tablets protect cardiomyocytes, antiodant, and has a lipid-lowring effect.The tablet had received the standard drugs contained in Hebei Province(1975 and1991),named Zhenjinganmian Pian.It had received in the national standard,named Xinshen Ning by2012.(WS-1041(ZD-0410)2002-2012Z).Chemical composition of traditional chinese medicine has a high degree of complexity,and overall therapeutic.The base of chinese medicine preparation technology and quality reasearch is weak.Quality control is not comprehensive enough.The current standard of Xinshen Ning includes only the determination of geniposide.So it is necessary to add the test project and index for studying the quality. And,using the comprehensive index as evaluation to explore the parameters of extraction process for Xinshen Ning.Then,refining, perfecting and optimizing the process parameters.Thus,the subject made a systematic study about extracting technology and testing standards of the process.The whole study is useful to improve the quality standard of Xinshen Ning, guarantee the stability of drug efficacy,and to provide a reference for process and quality standard of other products.Objective:1 To establish content determination method of geniposide and liquiritin in Xinshenning Tablets by using HPLC, and to determin two components,and to add item of content determination.2 To study the composition of semen ziziphi spinosae in Xinshenning Tablets,then,to establish the content determination method.3 To study systematicaiiy condition was optimized by Plackett-Burnman,Box-Behnken and response surface methodology with the comprehensive index.Then to refine,perfect and optimize the process parameters.Methods:1 The content determination of geniposide and liquiritin in Xinshen Ning tablets was performed on a Inertsil ODS-3(5μm,4.6mm×250mm) column,chromatographic conditions were determine wavelength:238nm,flow rate:1.0m L/min,column temperature 25℃, the mobilephase consisted of acetonitrile-water,sample size 10μL.2 Repeated and improved the literature’s method that the jujuboside A,B and spinosin in ziziphi spinosae semen of the xinshenning tablets. HPLC was used to establelish a determination method of spinosin in ziziphi spinosae semen of Xinshen Ning tablets. Perkin Elmer C18 column(5μm,4.6mm×250mm)was used.HPl C analysis was 25℃ and the mobilephase consisted of acetonitrile-water(0.1% acetic acid glacial),the detection wavelength was at 335nm;The flow rate :1.0ml/min, sample size 10μL.3 With the dry extract rate, the transfer rate ofgeniposide and spinosin as indexs, filtering the significancent factor by Plackett-Burnman design, and optimizing the significancent factor by Box-Behnken design,and processing the index,and optimizing the extraction process by reseponse surface analysis for Xinshen NingResults:1 The content determination method of geniposide and liquiritin in Xinshen Ning tablets was established by HPLC. The linear range of geniposide and liquiritin were 16.30~407.9 μg/m L(r=0.9999)and7.400-185.9μg/m L(r=0.9999).the average recovery of geniposide andliquiritin were 99.05%,RSD=1.28%(n=9)and98.00%,RSD=1.84%,(n=9),respectively.2 The method for spinosin is available.The linear range of spinosin is3.339-53.42μg/m L(r=0.9999),the average recovery of spinosin is100.91%,RSD=1.63%(n=9),respectively.3 The optimal extracting condition was extracted 3 times with 7.5 fold70% alcohol, 1.5 h for each time.Conclution:1This method is accurate,sensive,simple,stability,and has good reproducibility.It is suitable for the quality control of Xinshen Ning tablets.This method can be used as one of quality control means of Xinshen Ning tablets.2 Repeated,verificated and improved the literature’s methods,The result is that HPl C chromatograms for jujuboside A and jujuboside B of Xinshenning tablets is not the best.The method for spinosin isaccurate,sensive,simple,andstability,and has good reproducibility.It is suitable for the quality control of Xinshen Ning tablets.3 The optimized process condition was simple and feasible. It can be used the production.