熊胆冰片胶囊剂的制备及质量标准研究  

Study on preparation and quality standard of bear bile borneol capsules

作　　者：张馨月 吴澥 郑妍[1] 金鑫[1] 郭建鹏[1] ZHANG Xinyue;WU Xie;ZHENG Yan;JIN Xin;GUO Jianpeng(Key Laboratory of Natural Medicines of the Changbai Mountain Ministry of Education(Yanbian University),Yanji 133002,China;Jilin Vocational and Technical College,Longjing 133400,China)

机构地区：[1]长白山天然药物研究教育部重点实验室(延边大学),吉林延吉133002 [2]吉林职业技术学院,吉林龙井133400

出　　处：《延边大学学报(自然科学版)》2024年第4期34-46,共13页Journal of Yanbian University(Natural Science Edition)

基　　金：吉林省重点研发项目(20230204054YY)。

摘　　要：以熊胆粉(BBP)和冰片为主药制备了以微丸为内容物的熊胆冰片胶囊剂,并建立了其质量标准.采用正交试验法筛选出的冰片-β-环糊精(β-cyclodextrin,β-CD)包合物的最佳制备工艺为冰片∶β-CD=1∶6,包合时间为90 min,包合温度为30℃;以微丸的分布跨度和收率为指标筛选出的稀释剂比例为淀粉∶MCC=2∶1,润湿剂(蒸馏水)比例为50%;采用正交试验得到制备微丸的最佳工艺参数为:挤出频率为30 Hz,滚圆频率为40 Hz,滚圆时间为6 min.该方法制备熊胆冰片胶囊剂其工艺稳定、质量可靠.研究结果可为工业化生产熊胆冰片胶囊剂提供依据.The bear bile powder(BBP)and borneol were used as main ingredients to prepare bear bile borneol capsules with pellets as content,and the quality standard was established.The optimal preparation process for the inclusion complex of borneol-β-cyclodextrin(β-CD)selected by orthogonal experimental method is as follows:borneol:β-CD=1:6,inclusion time of 90 min,and inclusion temperature of 30℃;The diluent ratio selected based on the distribution span and yield of microspheres is starch:MCC=2:1,and the wetting agent(distilled water)ratio is 50%;The optimal process parameters for preparing microspheres were obtained through orthogonal experiments:extrusion frequency of 30 Hz,rolling frequency of 40 Hz,and rolling time of 6 min.The method for preparing bear bile borneol capsules has stable process and reliable quality,which can provide a basis for industrial production of bear bile borneol capsules.

关 键 词：熊胆粉 挤出-滚圆法 微丸 制备工艺 质量标准 

分 类 号：R943.1[医药卫生—药剂学]