薄荷油滴丸的制备工艺优化与质量评价  

Optimization of Preparation Process and Quality Evaluation of Peppermint Oil Dropping Pills

作　　者：杜卓[1] 刘正 严宇枫 林洁诚 余小姚 周宝珠 陈灏文 郭嘉亮 彭立生[2] DU Zhuo;LIU Zheng;YAN Yufeng;LIN Jiecheng;YU Xiaoyao;ZHOU Baozhu;CHEN Haowen;GUO Jialiang;PENG Lisheng(Department of Parmacy,Medical School,Foshan University,Foshan 528000,China;Department of Hepatology,Shenzhen Traditional Chinese Medicine Hospital,Shenzhen 518033,China)

机构地区：[1]佛山科学技术学院医学院药学系,佛山528000 [2]深圳市中医院肝病科,深圳518033

出　　处：《医药导报》2023年第4期547-551,共5页Herald of Medicine

基　　金：国家自然科学基金资助项目(81872832,82173781);广东省自然科学基金-面上项目(2019A1515010806);广东省教育厅普通高校科研项目特色创新类项目(2019KTSCX195);佛山科学技术学院2020年广东省科技创新战略专项资金(pdjh2020b0626)。

摘　　要：目的研究薄荷油滴丸的制备工艺并建立质量评价方法,筛选最优处方工艺。方法以滴丸成型、质量差异、脆碎度减重百分比、硬度大小、硬度差异为评价指标,采用L_(9)(3^(4))正交设计实验方法筛选制备滴丸的处方工艺。结果筛选出薄荷油滴丸的最优制备工艺:薄荷油含量百分比45%,滴制温度85℃,冷凝液高度8 cm,滴制距离6 cm。最优工艺所制滴丸中薄荷油含量为37.37%(RSD=1.45%,n=3);薄荷油浓度线性范围为0.09245~0.3698 mg·mL^(-1)(R^(2)=0.9998);平均加样回收率为97.98%(RSD=0.63%,n=3)。结论以最优工艺制得薄荷油滴丸外观圆整光洁,质量差异符合2020版《中华人民共和国药典》要求,制备滴丸的最优工艺稳定可行。Objective To study the preparation process of peppermint oil dripping pills and establish a quality evaluation method to screen the optimal formulation process.Methods Taking drop pill appearance,weight difference,friability weight loss percentage,hardness,and hardness difference as evaluation indicators,the L_(9)(3^(4))orthogonal design experiment method was used to screen the formulation process of dropping pills.Results The optimal preparation process of peppermint oil dripping pills was screened out:the percentage of peppermint oil content was 45%,and the dripping temperature was 85℃,and the height of the condensate was 8 cm,and the dripping distance was 6cm.The content of peppermint oil in the dripping pills prepared by the optimal process was 37.37%(RSD=1.45%,n=3);the linear range of peppermint oil concentration was 0.09245-0.3698 mg·mL^(-1)(R^(2)=0.9998);the average sample recovery rate was 97.98%(RSD=0.63%,n=3).Conclusion The peppermint oil dripping pills prepared under the optimal process have a round and smooth shape,and the weight difference meets the requirements of the 2020 edition of the Chinese Pharmacopoeia.The optimal process for preparing dripping pills is stable and feasible.

关 键 词：薄荷油滴丸 制备工艺 正交设计 质量评价 

分 类 号：R283[医药卫生—中药学] R94[医药卫生—中医学]