正交设计优选丁香酚滴丸的制备工艺  

Optimization of the Preparation Process of Eugenol Dropping Pills by Orthogonal Design

作　　者：杜卓[1] 叶泉英[1] 林洁诚 邝翠琼 莫玉芳[2] 余小姚 李海仪 郭嘉亮 DU Zhuo;YE Quanying;LIN Jiecheng;KUANG Cuiqiong;MO Yufang;YU Xiaoyao;LI Haiyi;GUO Jialiang(Department of Parmacy,Medical School,Foshan University,Foshan 528000,China;Department of Parmacy,the First People’s Hosptal of Foshan City,Guangdong Province,Foshan 528000,China)

机构地区：[1]佛山科学技术学院医学院药学系,佛山528000 [2]广东省佛山市第一人民医院药学部,佛山528000

出　　处：《医药导报》2021年第8期1100-1104,共5页Herald of Medicine

基　　金：国家自然科学基金资助项目(81872832,81503031);广东省自然科学基金-面上项目(2019A1515010806)。

摘　　要：目的对丁香酚滴丸的制备工艺及质量评价进行考察,筛选出最合适的处方工艺,研制出符合2015版《中华人民共和国药典》规定的丁香酚滴丸。方法采用L^(9)(3^(4))正交设计试验法筛选处方工艺制备滴丸,建立丁香酚滴丸含量测定方法。结果优选的丁香酚滴丸处方是:药物占总质量百分比为2.5%,药液温度为80℃,冷凝液下落距离为18 cm,药液滴距为6 cm。所制备丁香酚滴丸圆整度良好,硬度合适,质量差异符合《中华人民共和国药典》标准。结论该实验所制备丁香酚抗冠心病滴丸外观良好、硬度合适、滴丸质量差异符合2015版《中华人民共和国药典》对滴丸质量的要求。Objective The preparation process parameters and quality estimation of eugenol dropping pill were investigated to screen for the best preparation condition and to prepare the eugenol dropping pills that meet the requirements of the Chinese Pharmacopoeia 2015.Methods The L^(9)(3^(4))orthogonal design test method was used to screen the prescription and prepare the dropping pill.And the method for quality determination of eugenol dripping pills was established.Results The optimal prescription for preparing eugenol dropping pill is:The percentage of drugs in total mass was 2.5%,the temperature of the drug solution was 80℃,the dropping distance of the condensate was 18 cm,and the dropping distance of the drug solution was 6 cm.The results showed that the prepared dropping pills had good roundness,moderate hardness,and the mass difference meets the Chinese Pharmacopoeia’s standard.Conclusion The eugenol anti-coronary heart disease dropping pills prepared in the experiment have good appearance,suitable hardness,and the mass difference of dropping pills are in accordance with the requirements of Chinese Pharmacopoeia 2015.

关 键 词：丁香酚 滴丸 制备工艺 正交设计 质量评价 

分 类 号：R286[医药卫生—中药学]