某抗风湿中药医院制剂中添加结晶样物质的检测

Analysis of Crystalline Substances in a TCM Hospital Preparation for Treatment of Rheumatism

目的对某抗风湿中药医院制剂中可能添加的结晶样物质进行检测。方法在体式显微镜下挑选出制剂中的可疑结晶状物质后,分别采用气相色谱质谱联用仪以及高效液相色谱质谱联用仪进行检测。气相色谱质谱联用采用Agilent HP-5MS毛细管柱,电子轰击电离源测定。液相色谱质谱联用采用Agilent Zorbax SB-C18色谱柱,以乙腈和0.1%甲酸为流动相,电喷雾离子源测定。结果在该医院制剂中可检出吡罗昔康、醋酸泼尼松、吲哚美辛、布洛芬和维生素B2等5种化学药品。结论个别中药医院制剂中添加化学药品的情况应引起重视。

OBJECTIVE To analyze the potential adulterations in a traditional Chinese medicine hospital preparation for the treatment of rheumatism.METHODS The suspicious crystalline substances were isolated under a stereoscopic microscope,and analyzed with GC-MS and UHPLC-MS.GC-MS measurements were preformed on an Agilent HP-5MS column with ion electron impact ionization.UHPLC-MS measurements were preformed with Agilent Zorbax SB-C18 as stationary phase and the mixture of acetontrile-0.1%formic acid as mobile phase under electronic spray ionization mode.RESULTS Five kinds of chemical drugs were identified from the hospital preparation,including piroxicam,prednisone acetate,indomethacin,ibuprofen and vitamin B2.CONCLUSION More attention should be paid to the adulteration in some hospital preparations.