检查中药中非法掺入枸橼酸西地那非的方法研究  

Studies on the Methods for Determining Sildenafile Citrate Illegally Mixed in Traditional Chinese Medicine Preparations

作　　者：张启明[1] 尹华[1] 黄海伟[1] 朱维华[1] 俞如英[1] 

机构地区：[1]中国药品生物制品检定所

出　　处：《药物分析杂志》2002年第4期315-317,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:检查补肾壮阳的中药及中药保健品中非法掺入化学药——拘橼酸西地那非。方法:建立薄层色谱法、高效液相色谱法对可能掺入枸橼酸西地那非的中药及中药保健品进行分离分析,并用高效液相色谱-二极管阵列检测以及直接电喷雾离子阱质谱-质谱联用技术进行定性鉴定。结果:测定了22个厂家、十多种剂型的65批产品,发现其中13批非法掺入了枸橼酸西地那非。结论:所建方法专属性强、灵敏度高(单位制剂中含有μg级的枸橼酸西地那非即可检出),可作为监督检查此类掺假制剂的有效方法。Objective: To identify sildenafile citrate mixed illegally in traditional Chinese medicine ( TCM ) preparations. Methods: TLC and HPLC methods were established for the separation and determination of the organic extract of TCM preparations, and sildenafile citrate was identified by diode array detector and ESI - MS - MS. Results: 65 batches of more than ten dosages produced by several manufactories were determined. 13 batches of which contained sildenafile citrate. Conclusion: The methods are specific and sensitive ( the limit of detection was μg for each dose) , they can be used to detect the illegal TCM preparations.

关 键 词：枸橼酸西地那非 薄层色谱 高效液相色谱 质谱 补肾壮阳中药 药品质量监督 

分 类 号：R286.0[医药卫生—中药学]