The Study On Pharmaceutical Technology And Quality Standard Of Zhiwei Anshen Concentrated Pills

Objective:To study the preparation process and quality standards of Zhiwei Anshen Concentrate Pills.Methods:Single factor test and orthogonal test were used to evaluate the comprehensive scores of Schisandra arborvitae,Polygala saponin and extract yield.The extraction times,extraction time and water addition times were investigated and the best extraction process was optimized.The optimal molding process of Zhiwei Anshen Concentrate Pills was studied.The quality standards of Zhiwei Anshen Concentrated Pills were studied.Thin-layer chromatography was used to identify Shouwuteng and Suanzaoren in Zhiwei Anshen Pills.The method for the determination of schisin and saponin content in Zhiwei Anshen Pills was studied by HPLC.The determination method for the content of saponins of Polygala tenuifolia was:-0.5%aqueous solution of phosphoric acid(20:80)as mobile phase,detection wavelength at 210 nm,flow rate at 1 ml/min;determination of schisandrin content in methanol:water(25:75)as mobile phase,detection wavelength at 250 nm,flow rate 1 ml/min.The content of geniposide was determined by using acetonitrile-water(10:90)as the mobile phase,the detection wavelength was 238 nm,and the flow rate was 1 ml/min.Results:The best preparation process of Zhiwei Anshen Concentrate Pills was:according to the proportion of prescriptions,the prescriptions were taken into group prescriptions,semen date,and gardenia powder into fine powder;In 90 minutes,the extracts were combined and concentrated to a thick paste(60℃.)having a relative density of 1.30 to 1.40.The fine powder was mixed with the above fine powder to form pellets,which were dried and obtained.The TLC identification method for Shouwuteng and Suanzaoren in Zhiwei Anshen Concentrate Pills was established.The method for the determination of Polygala saponin,Schizandrol,and Geniposide in Zhiwei Anshen Concentrate Pills was established by HPLC.The linear relationship was good in the range of 23.56～117.80μg/ml,and the average recovery rate was determined.100.89%,RSD was 2.59%;Schizandrol A had a good linearity in the range of 10.312～51.560μg/ml,the average recovery was 101.07%,RSD was 2.28%,and geniposide was in the range of 0.8376～4.1880μg/ml.The internal linearity was good,the average recovery was 100.17,and the RSD was 2.70%.Conclusion:The preparation process of Zhiwei Anshen Concentrated Pills is reasonable,stable,and feasible.The established quality standards are stable and reliable,and can effectively control the quality of this preparation.