牛黄清心丸中黄曲霉毒素的检测

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 ChP 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 r esults may occur due to the matrix effects,it is suggested that a combination of GICA with IAC-HPLC method be used for further validation.

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