Study of Bacterial Endotoxin Test on 84 Drugs for Injection

CI Tong;ZHNG Guo-li;LI o;XIO Hu;ZHOU Jin-ping;ZHOU Li;CO Chun-rn;JIN Xin;JING Su-yun;ZHNG Xio-lin;LU Jing;ZHNG Ting-ting;LI ming;WNG Jing-rong;LIU Yong-guo;LI Jin-fei;ZHOU Zhi;CHEN ng-shu;YOU o-xing;LIU Ting-kui;YE Xio-qing;LI Yn-lin;HN Wen-hu;ZHNG Li-li0;ZHOU Ji-chun0;XU Xio-yue0;LI Zhn0;ZHOU Xio-ping;LI Qing-zhong;CHEN Zhi-ying;NIU Hui-ling;ZHOU Su-wen;XIO Wen-hu;YNG Y-ting;TIN Hong;OUYNG Jie-hu;LING Chun-hu;QIO Yn-ling;LU Hi-xi;WNG Di-yn;LU Yi-hong;WNG Xiu-ying;LIU Tong;WNG Dn;LI Sheng-gng;YNG Xio-feng;LIU Guo-hu;GUO Ming;ZHU Qing-fen;PIO Jin-hu;DONG Pei-zhi;GO Tin-hong;YN Ling-xio0;ZHO Yu-zhen0;XIO Zhen0;TNG Li-ming;ZHNG Zhen-yu;M Yu-ping;ZHNG Xio-ping;HN Wu-cheng;RUI Jing;SUN Shu-lin;HN Jing;YUN Qing-hu;GO Qiu-fng;YE Xio-min;HUNG Xio-dong;ZHENG Yu-pei;YNG Lin;DILINUER;YE Qing;GO Ju-zhen;ZHNG Hong-yu;WNG Li;WNG Lu;YO Zhi;ZHNG Jin-song;KUNG Rong;JI Yng;DI Y-min;JING Chun-li

Chinese Pharmaceutical Journal ›› 2010, Vol. 45 ›› Issue (2) : 150-155.

PDF(930 KB)
PDF(930 KB)
Chinese Pharmaceutical Journal ›› 2010, Vol. 45 ›› Issue (2) : 150-155.

Study of Bacterial Endotoxin Test on 84 Drugs for Injection

  • CAI Tong1, ZHANG Guo-lai1,LI Bo1*,XIAO Hua2,ZHOU Jian-ping3, ZHOU Li3, CAO Chun-ran3, JIN Xin3, JIANG Su-yun4, ZHANG Xiao-lian4,LU Jing4,ZHANG Ting-ting4, LI ming5,WANG Jiang-rong5, LIU Yong-guo5,LI Jin-fei6,ZHOU Zhi7,CHEN Bang-shu7,YOU Bo-xiang7,LIU Ting-kuai7,YE Xiao-qing8,LI Yan-lin8,HAN Wen-hua9,ZHANG Li-li10,ZHOU Ji-chun10,XU Xiao-yue10,LI Zhan10,ZHOU Xiao-ping11,LI Qing-zhong11,CHEN Zhi-ying11,NIU Hui-ling11,ZHOU Su-wen12,XIAO Wen-hua12,YANG Ya-ting12,TIAN Hong13,OUYANG Jie-hu13,LIANG Chun-hua14,QIAO Yan-ling14,LU Hai-xia14,WANG Dai-yan15,LU Yi-hong15,WANG Xiu-ying16,LIU Tong16,WANG Dan16,LI Sheng-gang17,YANG Xiao-feng17,LIU Guo-hua18,GUO Ming18,ZHU Qing-fen18,PIAO Jin-hua19,DONG Pei-zhi19,GAO Tian-hong19,YAN Ling-xiao20,ZHAO Yu-zhen20,XIAO Zhen20,TANG Li-ming21,ZHANG Zhen-yu21,MA Yu-ping21,ZHANG Xiao-ping21,HAN Wu-cheng22,RUI Jing23,SUN Shu-lian23,HAN Jing23,YUAN Qing-hua23,GAO Qiu-fang24,YE Xiao-min24,HUANG Xiao-dong25,ZHENG Yu-pei25,YANG Lin25,DILINUER26,YE Qing26,GAO Ju-zhen27,ZHANG Hong-yu27,WANG Li27,WANG Lu27,YAO Zhi28,ZHANG Jin-song28,KUANG Rong28,JI Yang29,DI Ya-min29,JIANG Chun-lai29
Author information +
History +

Abstract

OBJECTIVE To screen the drug for injection with Pyrogen test in Ch.P(2000)VolⅡ, to evaluate the possibility for the replacement with bacterial endotoxin test; and to investigate the methodology of the bacterial endotoxin test for all kinds of injections required for Pyrogen test in Ch.P(2000) Vol Ⅱ. METHODS Interference tests were done on each sample of injections by using bacterial endotoxin gel-method. The samples were provided by the collaboration of Pharmacology Divisions of Institute for Drug Control in 28 provinces or cities. RESULTS Determined the no interference concentration or the minimum no interference dilution of each drug and whether the drug is valid for bacterial endotoxin test. CONCLUSION 84 drugs for injection are valid for bacterial endotoxin test, and 16 drugs for injection are not suitable for bacterial endotoxin test.

Key words

KEY WORDS injection / bacterial endotoxin test / investigate the methodology

Cite this article

Download Citations
CI Tong;ZHNG Guo-li;LI o;XIO Hu;ZHOU Jin-ping;ZHOU Li;CO Chun-rn;JIN Xin;JING Su-yun;ZHNG Xio-lin;LU Jing;ZHNG Ting-ting;LI ming;WNG Jing-rong;LIU Yong-guo;LI Jin-fei;ZHOU Zhi;CHEN ng-shu;YOU o-xing;LIU Ting-kui;YE Xio-qing;LI Yn-lin;HN Wen-hu;ZHNG Li-li0;ZHOU Ji-chun0;XU Xio-yue0;LI Zhn0;ZHOU Xio-ping;LI Qing-zhong;CHEN Zhi-ying;NIU Hui-ling;ZHOU Su-wen;XIO Wen-hu;YNG Y-ting;TIN Hong;OUYNG Jie-hu;LING Chun-hu;QIO Yn-ling;LU Hi-xi;WNG Di-yn;LU Yi-hong;WNG Xiu-ying;LIU Tong;WNG Dn;LI Sheng-gng;YNG Xio-feng;LIU Guo-hu;GUO Ming;ZHU Qing-fen;PIO Jin-hu;DONG Pei-zhi;GO Tin-hong;YN Ling-xio0;ZHO Yu-zhen0;XIO Zhen0;TNG Li-ming;ZHNG Zhen-yu;M Yu-ping;ZHNG Xio-ping;HN Wu-cheng;RUI Jing;SUN Shu-lin;HN Jing;YUN Qing-hu;GO Qiu-fng;YE Xio-min;HUNG Xio-dong;ZHENG Yu-pei;YNG Lin;DILINUER;YE Qing;GO Ju-zhen;ZHNG Hong-yu;WNG Li;WNG Lu;YO Zhi;ZHNG Jin-song;KUNG Rong;JI Yng;DI Y-min;JING Chun-li. Study of Bacterial Endotoxin Test on 84 Drugs for Injection[J]. Chinese Pharmaceutical Journal, 2010, 45(2): 150-155

References


[1] Ch.P(2000)VolⅡ(中国药典2000年版,二部)[S]. 2000.
[2] Ch.P(2000)VolⅡ(中国药典2000年版,二部)[S].2000: Appendix Ⅺ E.
[3] USP25 [S].2002.
[4] BP2002[S].2002.
PDF(930 KB)

217

Accesses

0

Citation

Detail

Sections
Recommended

/