止痒搽剂质量控制标准的方法研究  

Method Analysis on Quality Control Standard of Anti-itch Liniment

作　　者：叶吉明[1] 杨景然 刘宇[1] 陈米林 冉忠梅[1] 周培德 柏永强 YE Jiming;YANG Jingran;LIU Yu;CHEN Milin;RAN Zhongmei;ZHOU Peide;BAI Yongqiang(Department of Pharmacy,The First People's Hospital of Yunnan Province,Kunming,Yunnan,China 650032;School of Science,Ningbo University of Technology,Ningbo,Zhejiang,China 315211;Department of Quality,Kunming Sainuo Pharmacy Co.,Ltd.,Kunming,Yunnan,China 650051)

机构地区：[1]云南省第一人民医院药学部,云南昆明650032 [2]宁波工程学院理学院,浙江宁波315211 [3]昆明赛诺制药股份有限公司质量部,云南昆明650051

出　　处：《昆明学院学报》2021年第3期114-118,共5页Journal of Kunming University

摘　　要：为制定止痒搽剂的质量控制标准,参照2015年版《中国药典:四部》中的原料药与制剂稳定性实验指导原则,采用气相色谱法对止痒搽剂中麝香草酚、薄荷脑、甘油和乙醇的含量进行测定,并对其系统稳定性进行考察.结果表明,薄荷脑和麝香草酚的质量浓度在0.016~0.161 mg/mL内与峰面积呈良好线性关系,平均加样回收率分别为100.19%和102.89%,RSD分别为0.60%和1.10%.说明测定结果特异性强,重现性良好,能够满足2015年版《中国药典:四部》中的相关要求.To establish the quality control standard of anti-itch liniment,referring to the guiding principles of stability test on APIs and preparations in Chinese Pharmacopoeia Part Four 2015 edition,Gas Chromatography is used to determine the content of thymol,menthol,ethanol and glycerin in anti-itch liniment and observe the system stability.The results show that the mass concentration of menthol and thymol is in the range of 0.016—0.161 mg/mL respectively and has a good linear relationship with the peak area.The average sample recovery rate is 100.19%and 102.89%respectively;RSD is 0.60%,1.10%respectively.So this method has strong specificity and good reproducibility,fully meets the relevant demands in Chinese Pharmacopoeia Part Four 2015 edition.

关 键 词：气相色谱法 麝香草酚 薄荷脑 乙醇 质量标准 

分 类 号：R284.1[医药卫生—中药学]