中药注射剂中蛋白质检查药典方法的假阳性原因探究  

Investigation on False Positive Results with Pharmacopoeia Method of the Protein Examination in Chinese Medicinal Injections

作　　者：郭青[1] 吴晓燕[2] 

机构地区：[1]江苏省食品药品检验所,南京210008 [2]南京中医药大学,南京210029

出　　处：《中国药品标准》2011年第3期219-223,共5页Drug Standards of China

摘　　要：目的:探究中药注射剂中蛋白质检查药典方法的假阳性原因,确保法定检验结果的正确性。方法:采用药典方法对某些中药注射液中间体及成品、增溶剂和助溶剂、中药有效成分进行实验,筛查阳性结果的具体物质,并对这些物质的结构进行归纳。结果:不饱和脂肪酸和酮、环状饱和脂肪酮和碱等有效成分和增溶剂如聚山梨酯、司盘、泊络沙姆,无论与酸产生沉淀与否,都不能采用鞣酸试液进行蛋白质检查;环状饱和脂肪酮如麝香酮、不饱和脂肪酸如亚麻酸、油酸等既不能采用鞣酸试液,也不能采用磺基水杨酸进行蛋白质检查。结论:中药注射剂中如果含有上述遇鞣酸或磺基水杨酸产生阳性结果的物质,会造成蛋白质检查的假阳性结果。Objective： To investigate the causes on false positive results with the pharmacopoeia method of protein examination in Chinese medicinal injections so as to ensure a correct result. Method： The pharmacopoeia method of protein examination in Chinese medicinal injections was used for the investigation, the intermediate and end products of some Chinese medicinal injections, solubilizers and cosolvents, and some effective compounds were tested to find out the specific substances that cause a positive result and summarize the common ground in structure of these substances. Results： For protein examination in Chinese medicinal injection, no matter what precipitation may produce when met with acid, the effective compounds and solubilizers such as Tween, Span and Poloxamer that are unsaturated fatty acid and ketone, saturated fatty ketone and alkaloid in ring structure, have to avoid using tannic acid as reaction agent; unsaturated fatty ketone such as musk ketone, unsaturated fatty acid such as linoleic acid and oleic acid etc. use neither tannic acid nor 5-sulfosalicylic acid as reaction agent. Conclusion： A false positive result would generate in protein examination, if Chinese medicinal injections contain the substances described above that cause a positive reaction with tannic acid or 5-sulfosalicylic acid.

关 键 词：中药注射剂 蛋白质 假阳性 

分 类 号：R921.2[医药卫生—药学]