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�й�ҩѧ��־ 2010, Vol. 45 Issue (21) :1667-1670    DOI:
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1.�Ͼ���ҽҩ��ѧ���Ͼ� 210046; 2.����ʡʳƷҩƷ���������Ͼ� 210008
WU Xiao-yan1, WANG Jing1, GUO Qing2, DI Liu-qing1*
1. Nanjing University of Chinese Medicine, Nanjing 210029, China��2. Jiangsu Institute for Food and Drug Control, Nanjing 210008, China

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Abstract�� OBJECTIVE To assay three components, which are effective but potentially cause ADRs, in 79 batches of Mailuoning Injections in order to conduct a safety analysis on the injection. METHODS The HPLC method was used for the analysis, the experiment was carried out on an Agilent Zorbax SB-C18 column (4.6 mm��250 mm��5 ��m) in a gradient elution with the mobile phase of MeOH-0.1% formic acid solution. DAD was used for detection, and the quantitative wavelength was set at 283 nm for 5-hydroxymethyl furfural and 325 nm for chorogenic acid and caffeic acid respectively. The column temperature was 20 ��.RESULTS In 79 batches of samples, 5-hydroxymethyl furfural, chorogenic acid and caffeic acid were in the range of 0.15%-0.41% (RSD=19.34%), 0.03%-0.07% (RSD=15.83%) and 0.02%-0.05% (RSD=18.88%), with average value of 0.28%, 0.05% and 0.03%, respectively.CONCLUSION The results showed that the variability of three components contained in 79 batches of samples were fluctuated to some extent. The mean of 5-hydroxymethyl furfural reached 0.28% that could have potential riskness in use, based on the limitation of 0.02% required in the standard of glucose injection.
Keywords�� 5-hydroxymethyl furfural,   chorogenic acid,   caffeic acid,   Mailuoning Injecton,   safety analysis     
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.Determination and Safety Analysis of 5-Hydroxymethyl Furfural, Chlorogenic Acid and Caffeic Acid in Mailuoning Injection[J]  Chinese Pharmaceutical Journal, 2010,V45(21): 1667-1670
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