液相色谱-质谱联用法检测治疗哮喘中药制剂中非法掺入化学药物成分

LC-MS detection of chemical components illegally adulterated into traditional Chinese medicine anti-asthma preparations

目的:建立检测治疗哮喘中药制剂中可能非法添加的4种化学药物成分(沙丁胺醇、茶碱、醋酸氢化可的松、醋酸泼尼松)的专属性方法。方法:采用 XTerra^(TM)-C_(18)色谱柱(2.1 mm×150 mm,5μm),以甲醇-10 mmol·L^(-1)醋酸铵溶液为流动相,以梯度洗脱程序进行洗脱。通过与对照品的液相色谱保留时间、紫外吸收光谱、相对分子质量、二级质谱信息比较,对治疗哮喘中药制剂中非法掺入的化学药物进行鉴别。结果:受试治疗哮喘中药制剂中分别检测到化学药物沙丁胺醇、茶碱、醋酸氢化可的松、醋酸泼尼松。结论:方法选择性强,结果准确可靠,可作为治疗哮喘中药制剂中非法掺入4种化学药物成分的有效检验方法,结果令人满意。

Objective：To establish a specific method for the identification of 4 chemical components （salbutamol, theophylline ,hydroeortisone acetate, prednisone acetate ） which may illegally adulterated into traditional Chinese medicine anti -asthma preparations. Method：The detection was performed on XTerraTM - C18 column （2. 1 mm× 150 mm, 5 μm） by gradient elution with methanol （A） -10 mmol· L^-1 ammonium acetate （B） as the mobile phase. After separated by HPLC, the extraction of the traditional Chinese medicine anti - asthma preparations was analyzed. The compounds illegally added were identified by chromatographic behavior, UV spectrum, relative molecular mass and mass spectral data in comparison with those of reference substances. Results： Salbutamol, theophylline, hydrocortisone acetate, prednisolone acetate were found in traditional Chinese medicine anti -asthma preparations. Conclusion：The method is selective, accurate and suitable for the detection of 4 chemical compounds illegally adulterated into traditional Chinese medicine anti - asthma preparations.