The Study On The Standard Of Fabrication And Quality Control Method Of Shenning Capsule

PURPOSE：The study aim at reform prescription of the Chinese patent medicine SHENNINGcapsule, which can be used in treating acute and chronic glomerulonephritis and chronicnephropathy, determine the crafts of fabrication, establish a mothed on distinguish the maincomposition of Astragalus, Salvia, Rehmannia and Dogwood by thin layer chromatography,insure their quality, effectiveness,stability and safty, provide a scientifical, reasonable andconveniently medicine for clinical.METHOD：1．Research the fabricate mothed, determine the crafts, and provide a pure Chinesetraditional medicine SHENNING capsule.2. Distinguish the monarch medcine such as Astragalus, Salvia, Rehmannia andDogwood by thin layer chromatography mothed, check the granularity, water content,measure the contents of miltiorrhiza by HPLC method and establish a resonable qualitycontrol mothed.3. Ascertain the stability after inspecting the capsule in0th,1st,2nd,3rd,6th and12thmonth under the room temperature according to the "Chinese pharmacopoeia" that "Themedicine stability tests principle", speculate the period of validity by warming up acceleratetest and regression analysis-based method.4．Statistical method: carry out data analysis by SPSS17.0, the mean of sample adopthomogeneity of variance analysis, t test and t2test, as the data of heterogeneity of variancecompared by non-parametric and rank sum test between groups.RESULTS：1. Determine the new SHENNING formulation, and the preparation was succeded.2．The mothed of TLC distinguish the monarch and his subjects in SHENNING capsuleand the HPLC mothed in measuring the contents of miltiorrhiza was succeded, which insuredquality control motheds. 3．Accelerate experiment by the constant temperature, indicates validity period ofSHENNING is5.88years under room temperature.CONCLUSION：The handicraft of SHENNING granules was reliable, the mothed in checking Astragalus,Salvia, Rehmannia and Dogwood by TLC and measuring the contents of miltiorrhiza byHPLC were can be repeated, it was reliable. The preparetion was succeded.