The Study On Preparation Technology And Quality Standardof Shiweibaihe Capsules

Objective:Traditional Chinese medicine(TCM) prescriptionof shiweibaihe capsulesis composed of Lily, Sophora flavescens, Radix Paeoniae Alba, Qingpi,Herba Agrimoniae, myrrh,yanhusuo,dandelion,Radix Notoginseng,licorice,et al., which have efficacy of qinghuashire, heweianchang, xiaozhangdingtong,and indicatestomachache, gastrectasia heartburn caused by shireyunjie,weishihejiang,pishijianyun.According to the Chinese herbal medicine new medicine technicalrequirements,Theoptimum preparationprocessand the method of determining the contents fromquantitative analysisto qualitative analysis was establishedin the paper by using the modern preparation technology and the method of orthogonal experiment.study the formulation and preparation procedure of Shiweibaihe Capsules and develop amethod for quality standards.Methods:The extraction process wasstudied by orthogonal experimental test as guided by water volume, extracting time, soaking time as factorsand the yield of extractas measuring index.The bestest granulating conditions of shiweibaihecapsuleswas studied,andby single-factor parallel to the experimentalmethods to inspect various affecting the capsule molding factors.The method of quality determination is as follows:Using the method of TLC toidentify the Radix Notoginseng inshiweibaihe Capsule.UsingHPLCto analyze thepaeoniflorin.Based on production process and the quality standards the quality of each batch is tested,and the long-term stability of the capsules is investigated by accelerated test.Results:The optimal extraction conditions:The first time used 11 times water,while the second used 4 times water.the time for each extraction was 1h respectively. The bestestgranulating conditions:Wetting agent was 95% alcohol.The proportion of extraction powder,dextrin and starch was 8:1:1.Shiweibaihe capsule’s qualitystandard is initialestablished.The identification by TLC was distinct, the spots were clearand specific. Determination method of paeoniflorin was linear at range of 2.112-11.374μg/ml.Thequalitystandard is sensitive,accurate,repeatableandspecifie.Qualityof the capsule is stablewithinoneyear.Conclusion:The water-soluble active components of the prescription can be extracted simultaneously by the extraction which is reasonable, feasible,and effective.Itcan be used for the preparation of Shiweibaihe Capsules. The grain of capsule made by thegranulating technology have goodproperties of shaping and small weight deviation. A quick, easy and accurate method was established and used for quality control of Shiwei Baihe Capsule.