Optimization Of Alcohol Precipitation Technology Of Chaifuxiaoru Granules Based On Index Components And Pharmacodynamics

Objective:Using the change of multi index components with the alcohol precipitation before and after and the pharmacodynamic test to optimized the alcohol precipitation process of Chai Fu Xiao Ru granule, and adopting the three batch production process validation with observing the effects of this product for breast hyperplasia in rats.Methods: With the chemical composition of multi-index( Saikosaponin a,Saikosaponin d, hesperidin, ferulic acid) and impurity removal rate as a comprehensive index, single factor experiment was used to investigate and optimize the best relative density of the initial paste and the best concentration of ethanol precipitation for the alcohol precipitation process of Chai Fu Xiao Ru granule. The HPLC method was applied to determine the the Saikosaponin a, Saikosaponin d,hesperidin and ferulic acid in Alcohol precipitation, and the methodology of the content determination has been investigated. The anti-inflammatory and analgesic functions of necessity to the alcohol precipitation and different concentration of alcohol precipitation were investigated by the model that xylene induced inflammation of the ear and acetic acid induced analgesic in mice. Through the test of three batches of production research, verifying the optimized extraction process. To establish the model of rat with hyperplasia of mammary glands,further study on the pharmacodynamics of Chai Fu Xiao Ru granule.Results:The relative density range of the optimum initial paste was 1.1-1.15, and the optimum concentration of alcohol precipitation was 60%. The method used in the determination of content is reliable and specific. Pharmacodynamic results indicated that the anti-inflammatory and analgesic effects after alcohol precipitation test are superior to extract alcohol precipitation before, and the 60% of ethanol concentration had the best efficacy. The three batch process shows that the process is stable and reasonable. In addition, Chai Fu Xiao Ru granule which optimized by the alcohol precipitation process can treat the rats with hyperplasia of mammary glands.Conclusion: Optimization of alcohol precipitation process can preserve the active ingredient perfectly, it provided the experimental basis for the rationality of traditional Chinese medicine alcohol precipitation process.