化浊散结除痹颗粒的制备工艺优化研究OA

Objective To optimize the preparation technology of Huazhuo Sanjie Chubi Granules.Methods An ultra-performance liquid chromatography(UPLC)method was established for the simultaneous determination of multiple components in the compound formula.The transfer rates of neoastilbin,isoastilbin,neoisoastilbin,astilbin,and berberine hydrochloride,along with the extract yield,were used as evaluation criteria.The effects of extraction time,water addition volume,and extraction frequency on the extraction process of Huazhuo Sanjie Chubi Granules were investigated through single-factor tests combined with an orthogonal test.The optimal forming process was selected by evaluating the angle of repose,screening excipients,and conducting process validation.The finalized process was further verified through pilot-scale production.Results The optimized preparation process for Huazhuo Sanjie Chubi Granules was as follows:extract the herbal pieces by heated reflax twice,first with 12 times the amount of water for 1.5 hours,then again with 12 times the amount of water for 1.0 hour.Combine the decoctions and concentrate under reduced pressure to a density of 1.07-1.08 g·cm³(65-75℃).Add 5％maltodextrin and perform spray drying(inlet temperature 175-185℃,outlet temperature 90-100℃).Add 0.3％silicon dioxide,0.1％magnesium stearate(based on the weight of dry extract powder),and an appropriate amount of maltodextrin.Mix uniformly and prepare granules via dry granulation,followed by particle sizing and packaging.Three batches prepared during the pilot-scale production showed satisfactory performance across all evaluation criteria,with minimal inter-batch variation.Conclusion The optimized preparation technology for Huazhuo Sanjie Chubi Granules is stable and reliable,providing a research foundation for the process standardization of this granule formulation.