对《中国药典》2020年版硫酸阿托品注射液含量测定的修订建议  

Revision suggestions on assay of Atropine Sulfate Injection in the Chinese Pharmacopoeia 2020

作　　者：邹纯才 万艳娟 鄢海燕 ZOU Chuncai;WAN Yanjuan;YAN Haiyan(Wannan Medical College,Wuhu 241002,China)

机构地区：[1]皖南医学院药学院,安徽芜湖241002

出　　处：《中国药品标准》2021年第4期360-366,共7页Drug Standards of China

基　　金：2018年度安徽省省级质量工程项目(2018jyxm1273);2020年安徽省高等学校省级质量工程一流教材建设项目《药物分析实验教程》(2020yljc129)。

摘　　要：目的:针对《中国药典》2020年版中硫酸阿托品注射液含量测定使用三氯甲烷作为萃取硫酸阿托品与酸性染料形成离子对溶剂的局限性,筛选三氯甲烷的替代溶剂并完善含量测定方法,为《中国药典》2020年版硫酸阿托品注射液含量测定的修订提出建议。方法:使用二氯甲烷、环己烷、正丁醇、乙酸乙酯、石油醚、乙醚等有机溶剂替代三氯甲烷对硫酸阿托品与酸性染料形成的离子对进行萃取,同时结合《中国药典》(2020年版)硫酸阿托品注射液含量测定方法,考察水相的pH和静置时间等对含量测定结果的影响。结果:用二氯甲烷作为萃取溶剂,水相pH=4,静置时间为1.5 h,其余条件参照《中国药典》2020年版酸性染料比色法测定硫酸阿托品注射液含量方法,可准确测定硫酸阿托品注射液的含量。线性回归方程为:A=-0.01683+60.6573C(r=0.9997),硫酸阿托品在0.02~0.32 mg·mL^(-1)范围内吸光度与溶液浓度线性关系良好。结论:可用二氯甲烷代替三氯甲烷用于酸性染料比色法测定硫酸阿托品注射液含量。Objective:To screen out the replacement solvent of trichloromethane and improve the assay method of Atropine Sulfate Injection in view of the limitation of using trichloromethane as extraction solvent for ion pairs formed by atropine sulfate and acid dyes in the assay method of Atropine Sulfate Injection in the Chinese Pharmacopoeia 2020.To provide the revision suggestions on the assay of Atropine Sulfate Injection.Methods:Dichloromethane,cyclohexane,n-butanol,ethyl acetate,petroleum ether,ether and other organic solvents were used to extract the ion pairs formed by atropine sulfate and acid dyes instead of trichloromethane.Meanwhile,the effects of the different aqueous phase pH and standing time on the assay results were investigated in combination with the assay method of Atropine Sulfate Injection in the Chinese Pharmacopoeia 2020.Results:The content of Atropine Sulfate Injection was accurately determined under the conditions of dichloromethane as extraction solvent,aqueous phase pH 4,and standing time 1.5 h,and other conditions referred to the acid dye colorimetric method for assay of Atropine Sulfate Injection in the Chinese Pharmacopoeia 2020.The linear regression equation was A=-0.01683+60.6573C(r=0.9997),and the linear range of atropine sulfate fell into 0.02-0.32 mg·mL^(-1).Conclusion:Dichloromethane can be used to replace trichloromethane in the assay of Atropine Sulfate Injection by acid dye colorimetry.

关 键 词：酸性染料比色法 硫酸阿托品注射液 二氯甲烷 

分 类 号：R921.2[医药卫生—药学]