首页|熊胆冰片胶囊剂的制备及质量标准研究

熊胆冰片胶囊剂的制备及质量标准研究

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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.
Study on preparation and quality standard of bear bile borneol capsules
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.

bear bile powderextruding-rounding methodpelletspreparation technologyquality standard

张馨月、吴澥、郑妍、金鑫、郭建鹏

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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

吉林职业技术学院,吉林 龙井 133400

熊胆粉 挤出-滚圆法 微丸 制备工艺 质量标准

2024

延边大学学报(自然科学版)
延边大学

延边大学学报(自然科学版)

影响因子:0.388
ISSN:1004-4353
年,卷(期):2024.50(4)