Study On Preparation Technology And Quality Control Of Fufang Xiaozuan Granules

Objective: To study and develop the preparation technology of Fufang Xiaozuan granules,establish the content determination method of Fufang Xiaozuan granules and discuss its anti-inflammatory effect on rats with chronic pelvic inflammation,so as to provide theoretical and experimental research basis for the industrial production of Fufang Xiaozuan granules.Methods:(1)Research on the extraction process of Fufang Xiaozuan granules: the central test-response surface method was adopted to optimize the extraction process of Fufang Xiaozuan with the weighted calculation of total flavonoids,total saponins and paste yield as evaluation indexes.The ethanol concentration,solid-liquid ratio and extraction time were investigated.(2)Research on the preparation molding technology: the dry paste obtained from the extraction was made into granules,and the concentration of ethanol,particle size,hygroscopicity,solubility and flavoring agent were investigated to optimize the best preparation technology.(3)Quality control study: HPLC method was used to determine the content of catechin,epicatechin and protocatechuic acid in the Fufang Xiaozuan granules.(4)The pharmacodynamics of Fufang Xiaozuan granules on rats with chronic pelvic inflammation: the anti-inflammatory effects of Fufang Xiaozuan granules were investigated from the aspects of body weight,uterine swelling degree and swelling rate,serum levels of interleukin-1β(IL-1β),IL-6,malonaldehyde(MDA)and superoxide dismutase(SOD).Results:(1)Based on the preliminary experiment and the results of single factor investigation,the extraction process of the Fufang Xiaozuan formula was further optimized by the central point experiment-response surface methodology.The optimized extraction parameters obtained are: 95%ethanol was used as the extraction solvent,the ratio of liquid to material was1:13,and the time was 100 min.(2)The optimal molding process of Fufang Xiaozuan granules: the process was to take a daily dose of Fufang Xiaozuan dry paste powder and add excipients to 18 g.The excipients are sucrose: medicinal dextrin =2:1 with85% ethanol as wetting agent and add 0.04-0.045% stevioside at the same time to pelletize.(3)To attain a convenient,efficient and accurate quality control method for Fufang Xiaozuan granules by establishing Quantitative analysis of multicomponents by single-marker for the detection of the three components in Fufang Xiaozuan granules(4)The results of pharmacodynamics study showed that the Fufang Xiaozuan granules prepared by three different extraction methods all had certain therapeutic effects on chronic pelvic inflammatory disease,and the mechanism might be related to the inhibition of the expression of pro-inflammatory factors and the enhancement of the body’s antioxidant capacity.In conclusion,the granules made by alcohol extract has the best therapeutic effect among the three.Conclusion: The extraction and preparation process of Fufang Xiaozuan granules were optimized by central design-response surface methodology and pharmacodynamics study.A method for the determination of catechin,epicatechin and protocatechuic acid in Fufang Xiaozuan granules was established.The pharmacodynamics results showed that the Fufang Xiaozuan granules prepared by the optimized process had a good anti-inflammatory effect on chronic pelvic inflammation on rats.The developed technology is stable and feasible,the product quality is stable and controllable,and the anti-inflammatory experiment results showed that good anti-inflammatory effect had been produced.The experimental results provided a theoretical basis for the further popularization and application of the Fufang Xiaozuan granules.