Studies on the Preparation Technology and Quality Standard of Baihuasandi Granules
|School||Central South University|
|Keywords||Baihuasandi granules orthogonal design preparation technology quality standard|
OBJECTIVEThrough a systematic study on the preparation technology and quality standard of Baihuasandi Granules，a good foundation is laid for reporting the new drugs application.METHODSThe transfer rate of Quercetin and the yield of extractum were determined as the evaluation standards to optimize and screen out the best extraction process by L(34) orthogonal design, Factors that affected the water extraction were extracting time, water adding amount and soak time. Factors that affected the alcohol precipitation were the concentration of alcohol and the ratio for qualitative of drug (g) and liquid volume (mL). In this study, with the transfer rate of Quercetin and the yield of extractum as the index, the concentrations of alcohol and the ratio of drug and solvent were investigated by single factor experiment to detect their influence on the water extracting technology and alcohol precipitation conditions. A series of experiments have been carried out in order to examine the hydroscopicity, angle of repose and bulk density of granules.In quality standard study, the primary medicines in the Baihuasandi granules are qualitatively tested by the TLC. The contents of Quercetin were determined by HPLC, the conditions were as follows:The Welch-C18 column(180×4.6mm,5μm) was adopted with the mobile phase of water-methanol-0.1% phosphoric acid (42:48:10), at the flow rate of 1.0 mL·min-1,and UV detection wavelength at 360nm,the column temperature was 30℃ RESULTSThe best conditions for water extraction of Baihuasandi granules were as follows:extracting 3 times,20 minutes for the first time,15 minutes for the second time and 15 minutes for the last time,and the added amount of water was 10 times,8 times and 8 times respectively. the herbs needn’t to be soaked.The optimum conditions for alcohol precipitation were as follows: the ratio for liquid volume (ml) and qualitative of drug (g) was 1.5, the concentration of alcohol liquid was 60%, then rest 24 hours. The preparation procedure were as follows:the relative density of extractum was concentrated to 1.20 (50℃), vacuum drying, then adding 16.7%of dextrin to produce granules with 95%alcohol.In quality standard study, the pictures of TLC were clear and negative contrast had no interference, the method was specific reproducible for identication of this Chinese medicine compound. And The evaluation targets of methodology meet the demands of qualitative analysis.CONCLUSIONFrom the results of the study, we can draw a conclusion that the preparation technology is reasonable, the quality of the product is stable and the testing method is scientific. Thus, the study meet the standard of a modem Chinese medicine.