高效液相色谱法检测中药制剂中非法添加的抗真菌药物

目的建立检测中药制剂中可能非法添加的8种化学抗真菌药物的高效液相色谱法。方法色谱柱为Luna ODS C18柱(250 mm×4.6 mm,5μm),流动相为甲醇-0.2%磷酸二氢钾水溶液梯度洗脱,流速为1 mL/min,检测波长为200～400 nm;柱温为35℃。结果在该色谱条件下,氟康唑、灰黄霉素、酮康唑、克霉唑、伊曲康唑、硝酸益康唑、硝酸咪康唑、盐酸特比萘芬8种抗真菌化学药物可得到有效分离、检测,平均回收率分别为93.92%,90.63%,95.88%,99.34%,97.82%,97.16%,97.91%,85.12%,RSD分别为0.30%,0.21%,0.41%,0.36%,1.39%,0.39%,0.52%,0.19%。结论该方法简便、准确,重现性好,可用于中药制剂及中成药中抗真菌化学药物的筛查。

Detection of Antifungal Chemical Drugs Illegally Added into Traditional Chinese Medicine Preparations by HPLC

Objective To establish a HPLC method for the detection of 8 kinds of antifungal chemical drugs probably illegally added into the traditional Chinese medicine preparations.Methods The HPLC method was developed.The separation was performed on the Luna ODS C18 column（250 mm×4.6 mm,5 μm）.The mobile phase consisted of methanol-0.2%potassium dihydrogen phosphate aqueous solution with the gradient elution.The flow rate was 1 mL/min.The detection wavelength was 200-400 nm and the column temperature was kept at 35 ℃.Results Under this developed chromatographic conditions,8 kinds of antifungal chemical drugs including fluconazole,griseofulvin,ketoconazole,clotrimazole,itraconazole,econazole,miconazole nitrate,terbinafine hydrochloride were able to be separated and detected effectively.The average recovery rates were 93.92%,90.63%,95.88%,99.34%,97.82%,97.16%,97.91%and 85.12%,RSD were 0.30%,0.21%,0.41%,0.36%,1.39%,0.39%,0.52%,0.19%,respectively.Conclusion The established method is simple,accurate and better reproducible,and can be used for screening detection of illegally added antifungal chemical drugs in the traditional Chinese medicine preparations and the Chinese patent medicine preparations.