小鼠淋巴细胞增殖法评价热毒宁注射液中间体和制剂的致敏性

周婧,马宏跃*,范麒如,,吴启南,萧伟,*,王团结,,张军峰,詹瑧,佟书娟

中国药学杂志 ›› 2015, Vol. 50 ›› Issue (7) : 586-589.

PDF(631 KB)
PDF(631 KB)
中国药学杂志 ›› 2015, Vol. 50 ›› Issue (7) : 586-589. DOI: 10.11669/cpj.2015.07.006
论著

小鼠淋巴细胞增殖法评价热毒宁注射液中间体和制剂的致敏性

  • 周婧1,马宏跃1*,范麒如2,4,吴启南1,萧伟2,4*,王团结2,4,张军峰3,詹瑧3,佟书娟3
作者信息 +

Allergenicity Evaluation of Reduning Injection and Intermediate Using the Mouse Spleen Cell Proliferation Assay

  • 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
Author information +
文章历史 +

摘要

目的 采用小鼠淋巴细胞增殖法,评价热毒宁注射液中间体和成品制剂的致敏性。方法 热毒宁制剂经3KD超滤富集制备大分子部位,加入小鼠脾脏单个核细胞培养3 d,台盼蓝染色活细胞数目,以评价中药注射液的致敏性强度。结果 热毒宁中间体1号有最强的淋巴细胞刺激作用,随着中间体工艺精制,中间体2~5号的刺激活性依次减弱。使用该模型对热毒宁成品注射液的检测,发现已知具有临床不良反应的批次均有显著淋巴细胞刺激性,而已知无临床不良反应批次无刺激性。并发现两个批次未知样本存在淋巴细胞刺激性。结论 热毒宁的四步精制工艺排除了原料中的淋巴细胞刺激性的物质。热毒宁成品制剂基本没有该刺激作用,但已知临床过敏反应的批次仍具有淋巴细胞刺激作用。3KD超滤富集-单个核细胞体外增殖模型,可用于热毒宁注射液中大分子物质的检测。

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.

关键词

药物过敏反应 / 单个核细胞 / 热毒宁注射液 / 超滤富集

Key words

drug allergic reactions / mononuclear cells / Reduning injection / ultrafiltration concentration

引用本文

导出引用
周婧,马宏跃*,范麒如,,吴启南,萧伟,*,王团结,,张军峰,詹瑧,佟书娟. 小鼠淋巴细胞增殖法评价热毒宁注射液中间体和制剂的致敏性[J]. 中国药学杂志, 2015, 50(7): 586-589 https://doi.org/10.11669/cpj.2015.07.006
ZHOU Jing, MA Hong-yue*, FAN Qi-ru,, WU Qi-nan, XIAO Wei,*, WANG Tuan-jie,, ZHANG Jun-feng, ZHAN Zhen, TONG Shu-juan. Allergenicity Evaluation of Reduning Injection and Intermediate Using the Mouse Spleen Cell Proliferation Assay[J]. Chinese Pharmaceutical Journal, 2015, 50(7): 586-589 https://doi.org/10.11669/cpj.2015.07.006
中图分类号: R965   

参考文献

[1] FENG X Z,ZHOU F,HUANG M,et al. Inhibitive effect of Reduning on the influenza virus FM1 . Chin J New Drugs Clin Remed(中国新药与临床杂志),2007,26(9):663-664. [2] HUANG J J. Document analysis of 28 cases of Reduning injection adverse effect . J Huaihai Med (淮海医药),2011,29 (2):164-165. [3] XIAO X,FU C,LIANG Q L,et al. Determination content of protein in Chinese medicine Injection. Chin Pharm J (中国药学杂志),2012,47(21):1768-1769. [4] DUAN W G,KE J,LI Q F, et al. Detection of condensed tannin in herb injections by use of protein coated PVDF membrane. Chin Tradit Pat Med (中成药),2011,33 (11):1916-1919. [5] GAO X Y,FAN Q,LI N,et al. Characterization and determination of nitrogen in preparation of Qingkailing injection and its intermediate products. China J Chin Mater Med(中国中药杂志),2008,33 (14):1673-1678. [6] GUO S S,WANG Y Z,JIN Y H,et al. Establishment and applicability evaluation of animal model which was suitable to evaluate immediate hypersensitivity induced by injections of traditional Chinese medicine in BN rats. China J Chin Mater Med (中国中药杂志),2011,36 (14):1845-1849. [7] YU F P,HU C H,CUI S X,et al. Analysis of allergic dopants in Ciwujia injection. Chin Pharm J (中国药学杂志),2008,43(5):384-387.[8] ILLING P T, VIVIAN J P, DUDEK N L, et al. Immune self-reactivity triggered by drug-modified HLA-peptide repertoire . Nature, 2012, 486(7404):554-558.

基金

江苏省中药资源产业化过程协同创新中心基金资助项目(ZDXM-1-14);中药制药过程新技术国家重点实验室开放课题资助项目(SKL2010Z0404);江苏省中医药局康缘中医药科技创新基金资助项目(HZ1007KY);江苏高校优势学科建设工程资助项目
PDF(631 KB)

Accesses

Citation

Detail

段落导航
相关文章

/