Preparation And Quality Standard Study Of Shenshuaikang Granules

Objective: The present studies are aim to optimize the extraction and molding technology,determine the optimum preparation process and establish the quality standards of Shenshuaikang granules,which could be used to control the quality during the process of production.Meanwhile,the primary stability was also investigated to provide basis for preparation packaging and storage.Methods: The orthogonal design was used and the major influential factors of Shenshuaikang granules extraction(decoction time,water times and medicinal material particle)were detected to determine the optimum conditions of extraction,which was evaluated with emodin content and dry extract yield.The main influential factors of the molding technique including the excipients proportion,dosages and ethanol concentrations were evaluated with yield of qualified granules,dissolubility,hygroscopicity and liquidity.The optimal technique of Shenshuaikang granules was investigated by central composite design-response surface methodology.Radix Astragali,Radix et Rhizome Rhei,Lycii Fructus,Radix et Rhizome Glycyrrhizae were identified by thin-layer chromatography(TLC).The content of Radix et Rhizome Rhei was measured by high performance liquid chromatography(HPLC).Agilent HC-C18(4.6 mm ID× 250 mm,5?m)column was used.The column temperature was 30?.Methyl alcohol-0.1%phosphoric acid solution(85:15)was used as mobile phase.The detection wavelength was 254 nm.The flow rate was 1.0 ml/min.Three batches of Shenshuaikang granules were put in the incubator(temperature 40? ± 2?,relative humidity 75% ± 5%).The samples were collected after 0,1,2,3 and 6 month storage for identification,examination,content determination and microbial limit test.Results: The optimum conditions of extraction technology by orthogonal design of granules were as follows: the water times was 12;the decoction time was 60 min;the medicinal material particle size was fine powder.Under this extraction technology,emodin content was 0.1928mg/g and dry extract yield was 8.82%.The optimal molding technique by CCD-response surface methodology were as follows: the proportion of excipents(soluble starch: dextrin)was 2.5:1;the dosages of excipents was 2:1;the ethanol concentration was 60%.In TLC chromatograms,the feature spot was obvious without interference of negative control.Emodin and Chrysophanol showed a perfect linear relationship at 1.8~18.0 ?g/ml and 0.5~12.0 ?g/ml(r = 0.9997,r = 0.9997).The Average recoveries of added sample were 99.94 %(RSD = 1.26 %)and 100.69 %(RSD = 1.88 %).The primary stability test showed that the three batches samples conformed to the regulation under the condition of the temperature of 40? ± 2? and relative humidity of 75% ± 5%.Conclusions: The optimum extraction determined by orthogonal design shows that the result is stable and reliable;the method is simple and feasible.The granules produced by the optimal molding technique using the three factors five levels of CCD-response surface method show the excellent moisture resistance,moderate granularity.Moreover,the results of validation test also indicate that the predictability and reliability of the model is outstanding.The method is convenient,accurate and reliable for the quality control of Shenshuaikang Granules.The primary stability test shows that the stability of preparation is pleasurable in the normal room temperature.