Abstract: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.
何轶, 李静, 余坤子, 王菲菲, 张聿梅, 于健东, 戴忠, 马双成. 某抗风湿中药医院制剂中添加结晶样物质的检测[J]. 中国药学杂志, 2020, 55(7): 549-556.
HE Yi, LI Jing, YU Kun-zi, WANG Fei-fei, ZHANG Yu-mei, YU Jian-dong, DAI Zhong, MA Shuang-cheng. Analysis of Crystalline Substances in a TCM Hospital Preparation for Treatment of Rheumatism. Chinese Pharmaceutical Journal, 2020, 55(7): 549-556.
HUANG B B, XU M Z, YANG Q Y, et al. Review of the approved supplementary testing methods and items on identifying adulterated chemical substances in traditional Chinese medicine preparations and herbal medicines [J]. Chin J Pharm Anal(药物分析杂志), 2014, 34 (9):1701-1708.
[2]
HUANG B B, YANG Q Y, XU M Z, et al. Review on the management of supplementary testing methods and items and recommendations for furture development [J]. Chin Pharm Aff(中国药事), 2014, 28 (5):453-456.
[3]
LIU X. Primary exploration on drug supplementary testing methods and items [J]. Chin Food Drug Admin (中国食品药品监管), 2014, (10):59-60.
[4]
YUN J, SHIN K J, CHOI J, et al. Identification and structural elucidation of a new sildenafil analogue, dithiopropylcarbodenafil, from a premixed powder intended as a dietary supplement [J]. J Chromatogr B, 2018, 1072:273-281.
[5]
KEE C L, GE X, LOW M Y, et al. Structural elucidation of a new sildenafil analogue using high-resolution orbitrap mass spectrometry [J]. Rapid Commun Mass SP, 2013, 27:1380-1384.
[6]
GE X, LI L, KOH H L, et al. Identification of a new sildenafil analogue in a health supplement [J]. J Pharm Biomed, 2011, 56:491-496.
[7]
LUO J N, TAN L, CAO L, et al. Determination of 15 antiepileptic and hypnotic compounds illegally adulterated into traditional Chinese medicines by LC-MS/MS [J]. Chin J Biochem Pharm (中国生化药物杂志), 2010, 31 (3):162-166.
[8]
ZHU X H, MA P F, XU X, et al. Quanlitative determination of sedative-hypontic drugs illegally added in health foods and traditional Chinese medicines by GC-MS [J]. Chin Pharm (中国药业), 2012, 21 (19):36-38.
[9]
ZHU X H, LI T, MA P F, et al. GC-MS identification of benzodiazepine drugs [J]. Chin J Pharm Anal (药物分析杂志), 2012, 31(12):2289-2293.
[10]
HE Y, ZHANG Y, LU J, et al. Isolation and structural elucidation of abietic acid as the main adulterant in an herbal drug for the treatment of psoriasis [J]. J Pharm Biomed, 2012, 66:345-348.
[11]
LIU Y W, ZOU Y H, YIN H M. Identification of a tadalafil analogue based on Q-TOF-MS [J]. Chin Pharm J(中国药学杂志), 2016,51(23):79-82.
[12]
GONG L P, TIAN C Y, GUO C C, et al. Rapid screening and quantitative detection of 24 illegally added anti-inflammatory painkillers in traditional Chinese medicines and health foods by ultra performance liquid chromatography-quadrupole/electrostaticfield orbitrap high resolution mass spectrometry [J]. Chin Pharm J(中国药学杂志), 2015, 50(24):2154-2159.
[13]
GAO Q, CHE B Q, ZHANG Z, et al. Identification of 16 sedative-hyponotic drugs in traditional Chinese medicines and health foods by LC-MS/MS [J]. J Chin Pharm Univ(中国药科大学学报), 2008, 39 (2):142-146.
[14]
HUANG X J, GAO Q, ZHU X Y, et al. Simultaneous determination of nine antiviral agents illegally adulterated into traditional Chinese medicines by HPLC-MS /MS [J]. Chin Pharm J(中国药学杂志), 2014, 49(5):419-422.
[15]
LIU Z T, YANG L P. Identification of 5 kinds of quinolones in hospital preparation by LC-MS [J]. Shanxi Med J (山西医药杂志), 2018, 47(3):581-582.
[16]
XIAO L H, GUAN X Y, LIU J J, et al. Identification of estazolam in traditional Chinese medicine and health foods by GC-MS/MS [J]. Chin Mod Med (中国当代医药), 2013, 20(13):53-54.
[17]
LIU J J, XIAO L H, GUAN X Y, et al. GC-MS determination of 14 sedative-hyponotic drugs illegal mixed in traditional Chinese medicines and health foods [J]. Chin J Pharm Anal (药物分析杂志), 2011, 31 (2):376-379.
[18]
LI T, ZHU X H, LIN F. GC-MS determination of chemical drugs in Chinese patent medicine and health food [J]. Chin J Pharm Anal (药物分析杂志), 2010, 30(11):2212-2215.
[19]
MCFADDEN W H. GC-MS and Its Application on the Organic Analysis[M]. Beijing:Science Press, 1983:14-21.