固肾止遗双子颗粒的制备工艺研究

Preparation technology of Gushen Zhiyi double seeds granules

目的探究固肾止遗双子颗粒的制备工艺。方法采用单因素试验结合星点设计优化,以五味子醇甲含量及干膏得率作为评价指标,进一步优选工艺,以颗粒的成型率、休止角、堆密度、吸湿率、溶化性作为考察指标,对辅料的种类、用量、润湿剂及干燥时间进行工艺优化,按2020年版《中国药典》对制得的颗粒进行相关检查。结果颗粒剂最佳提取工艺:提取次数2次,溶媒量8倍,提取时间2 h。制剂工艺:选择糊精和微晶纤维素作为辅料,糊精与微晶纤维素比例为2∶1,70%乙醇作为润湿剂,颗粒剂干燥时间2 h。验证试验结果显示,3批固肾止遗双子颗粒大小、粒度均匀,外观呈米黄色,气微香,溶化性、成品率、含水量各项指标均符合2020年版《中国药典》相关项下的规定。结论此研究可为固肾止遗组方后续的体内研究提供理论依据,并为进一步的工业化生产提供技术指导。

Objective To improve the preparation technology of Gushen Zhiyi double seeds granules.Methods The single-factor test combined with central composite design was used to optimize the process,with the content of schisandrin A and dry extract yield as the evaluation indexes.The forming rate,resting angle,stack density,moisture absorption rate and dissolubility of the granules were used as evaluation indexes.The type,amount,wetting agent and drying time of auxiliary materials were optimized,and the prepared granules were inspected according to the Chinese Pharmacopoeia(2020 Edition).Results The best extraction process for the granules included 2 extractions,8 times of solvents,extraction for 2 h.The preparation process:dextrin and microcrystalline cellulose served as excipients for this preparation,the ratio of dextrin to microcrystalline cellulose was 2∶1,70%ethanol was used as the wetting agent,and the drying lasted 2 h.The granule validation results:three batches of Gushen Zhiyi granules showed uniform size and particle size,with beige appearance.The slight fragrance,and the indexes of solubility,yield and water content all met the requirements of the Chinese Pharmacopoeia(2020 Edition).Conclusion This study provides a theoretical basis for the subsequent in vivo pharmacological experimental study of the formula and technical guidance for further industrial production.