Study On Preparation Technology And Quality Standard Of ShenJing Tablet

Purpose:To study the preparation process of ShenJing tablet,and to establish the quality standard of ShenJing.Method:1.By summarizing the literature and combining with the actual production level,the preparation process technical route was designed and got through,and using single factor test and multi-factor,multi-level test optimize the preparation process parameters.finally,the optimum preparation process of the preparation was determined by the small test process verification and the pilot test process verification.2.Refer to Chinese pharmacopoeia 2015 edition,departmental standard,and use chemical analysis,spectral analysis,chromatographic analysis,limit test,characteristic test,biological test to analyzed and investigated the sensory perception,physical and chemical examination,disintegration time limit,weight difference,microbial limit,TLC identification,content determination of the preparation,and to establish the quality standard of ShenJing.3.A method for the simultaneous determination of salidroside and 10-hydroxy-alpha-decenoic acid was established by using multiple evaluation technique.Result:1.The formula is composed of rhodiola rosea,ginseng,huangjing,royal jelly freeze-dried powder,starch,dextrin and magnesium stearate.2.After the study of the small test process verification and the pilot process verification,the optimum preparation process of the preparation was determined as follows:ginseng is broken(60? dry if necessary),crushed into fine powder.The Rhodiola and Huangjing were extracted by adding 10 times and 8 times of water for 2 times,1h each time.The filtrate was concentrated under vacuum drying oven,and pulverized into a fine powder.The dry paste fine powder is thoroughly mixed with ginseng powder,royal jelly lyophilized powder,starch and dextrin.granulation(wetting agent: 85%ethanol;granulation number:18 mesh;formation number:16 mesh),add magnesium stearate,mix well,press,coat,inspect,pack and get the finished product.3.The name and sense organs of the preparation were determined,and physical and chemical examination,disintegration time limit,weight difference and microbial limit were specified.the TLC method for the identification of salidroside,ginsenoside and the content determination method for salidroside,ginsenoside and 10-HAD had were establishhed and the minimum content of each index wasspecified.finally,the quality standard of this product was established.Conclusion:The optimum preparation technology and quality standard of shenjing were selected,the preparation process is reasonable,feasible,stable and controllable.The quality standards formulated are scientific,reasonable,practical and feasible.The method is accurate,sensitive,simple and rapid.