明胶空心胶囊以及肠溶明胶空心胶囊鉴别试验改进研究  

Improvement study on the identification test of vacant gelatin capsules and enterosoluble vacant gelatin capsules

作　　者：郭文旭 王丹丹 周涛 章蔼静 陈悦 GUO Wen-xu;WANG Dan-dan;ZHOU Tao;ZHANG Ai-jing;CHEN Yue(Zhejiang Institute for Food and Drug Control,Zhejiang Key Laboratory of Drug Contact Material Quality Control Research,Hangzhou 310052,China;China Pharmaceutical University,Nanjing 210009,China;Guangdong Kaiping Jinyi Capsule Co,Kaiping 529300,China)

机构地区：[1]浙江省食品药品检验研究院浙江省药品接触材料质量控制研究重点实验室,杭州310052 [2]中国药科大学,南京210009 [3]广东开平金亿胶囊有限公司,开平529300

出　　处：《药物分析杂志》2024年第2期368-372,共5页Chinese Journal of Pharmaceutical Analysis

基　　金：浙江省药品监管系统科技计划项目(2022004)。

摘　　要：目的:对比国内外药典中明胶类空心胶囊鉴别试验的差异,优化鉴别试验方法,提高鉴别结果的专属性。方法:采用双缩脲反应对明胶类空心胶囊进行鉴别,通过加入适量的吸附活性炭,消除空心胶囊中色素的遮蔽效应。结果:鉴别方法经优化后,胶囊溶液中色素被活性炭吸附,胶囊溶液呈现澄清无色溶液,双缩脲反应显色后能产生明显的蓝紫色。结论:该方法对比国内外药典方法,能显著提高对明胶类空心胶囊鉴别的专属性,可为《中华人民共和国药典》中明胶空心胶囊和肠溶明胶空心胶囊鉴别试验的优化改进提供科学合理的修订建议。Objective:To compare the differences in identification tests of vacant gelatin capsules and enterosolu⁃ble vacant gelatin capsules in the four national pharmacopoeias,optimize the identification test methods and improve the specificity of identification results.Methods:The biuret method was used to identify vacant gelatin capsules and enterosoluble vacant gelatin capsules,and an appropriate amount of adsorbed activated carbon was added to eliminate the masking effect of pigments in capsules.Results:The identification method was optimized,the pigment in the capsule solution was adsorbed by activated carbon,and the capsule solution showed a clarified colorless solution,which could produce a distinct violet after the color development by biuret reaction.Conclusion:This method can significantly improve the specificity of vacant gelatin capsules and enterosoluble vacant gelatin capsules identification compared with domestic and foreign pharmacopoeia methods.It can provide scientific and reasonable revision suggestions for the optimization and improvement of the identification test of va⁃cant gelatin capsules and enterosoluble vacant gelatin capsules in the Chinese Pharmacopoeia.

关 键 词：药典 明胶空心胶囊 肠溶明胶空心胶囊 鉴别试验 双缩脲反应 活性炭吸附 

分 类 号：R917[医药卫生—药物分析学]