牛黄清心丸中黄曲霉毒素的检测

Rapid analysis of aflatoxin in Niuhuang Qingxin pills

目的:采用胶体金免疫层析技术(GICA)对牛黄清心丸(局方)中黄曲霉毒素总量和黄曲霉毒素B1的含量进行检验,建立含有29味药材的复杂基质中黄曲霉毒素的快速筛查的方法。方法:以38批次牛黄清心丸(局方)的水丸和蜜丸为研究对象,采用GICA快速检测样品中黄曲霉毒素含量,并选用免疫亲和柱-高效液相色谱(IAC-HPLC)的方法进行比对,排除假阳性结果。结果:38批次样品有5批次检出黄曲霉毒素,检出率为13.16%,但均未超过中国药典2010年版限量规定,合格率为100%。经IAC-HPLC法验证,有3批次为假阳性结果。结论:GICA方法操作简单、快速,适合大规模快速筛查使用,但由于中成药复杂基质影响,有时会出现假阳性结果,建议和IAC-HPLC方法联合使用,以提高数据可靠性。

Objective： To develop the immune colloidal gold technique（ GICA） for fast detection of the total amount of aflatoxin and the content of aflatoxin B1 in Niuhuang Qingxin pills（ pharmacopoeia） so as to establish a rapid screening method for aflatoxin in the complex matrix composed of 29 herbal medicines. Methods： Totally 38 batches of samples were studied. In order to avoid false positives,aflatoxin in water-bindered pills and water-honeyed pills were determined by GICA and were compared by immunoaffinity column-high performance liquid chromatography（ IAC-HPLC）. Results： The positive detection rate for aflatoxin was 13. 16%（ 5 batches）,which did not exceed the Ch P 2010 requirements. The qualified rate of the 38 batches was 100%. The results from the GICA analysis were verified by the IAC-HPLC tests which revealed that 3 batches had false positive results. Conclusion： The GICA method was easy,rapid and suitable for large-scale screening. As some false positive results may occur due to the matrix effects,it is suggested that a combination of GICA with IAC-HPLC method be used for further validation.