ZHOU Jing1, MA Hong-yue1*, FAN Qi-ru2,4, WU Qi-nan1, XIAO Wei2,4*, WANG Tuan-jie2,4, ZHANG Jun-feng3, ZHAN Zhen3, TONG Shu-juan3
1. Nanjing University of Chinese Medicine, Collaborative Innovation Center of Chinese Medicinal Resources Industrialization, Nanjing 210023, China; 2. Jiangsu Kanion Pharmaceutical CO. LTD, Lianyungang 222001, China; 3.Department of Basic Medicine, Nanjing University of Chinese Medicine, Nanjing 210023, China; 4.State Key Laboratory of New Technique for Chinese,Nanjing 210023, China
Abstract��
OBJECTIVE To evaluate the allergenicity of Reduning injection and intermediate using ultrafiltration and the mouse spleen cell proliferation assay.METHODS The samples obtained by 3kd ultra-filtration, were incubated with mouse spleen mononuclear cells for 3 d, and then the trypan blue staining was used to count the alive cells for the evaluation of drug allergenicity.RESULTS Effect of No. 1 of Reduning intermediate was strongest to stimulate proliferation of mononuclear cells, and then actions of No.2-5 decreased in turn, after the refining processing.CONCLUSION A four-step refining process reduces the stimulated actions of Reduning intermediates on the mononuclear cell proliferation. Most Reduning injection have no this action, but several batches of samples with known clinical allergic reaction have the stimulated actions on the mononuclear cell proliferation. Ultrafiltration-mononuclear cell proliferation assay could be used for the determination of macromolecular substances from Reduning injection.
ZHOU Jing-,
MA Hong-Yue-*,
FAN Qi-Ru- etc
.Allergenicity Evaluation of Reduning Injection and Intermediate Using the Mouse Spleen Cell Proliferation Assay[J] Chinese Pharmaceutical Journal, 2015,V50(7): 586-589
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2015, Vol. 50 