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Journal of Chinese Pharmaceutical Sciences ›› 2018, Vol. 27 ›› Issue (6): 436-441.DOI: 10.5246/jcps.2018.06.044

• Original articles • Previous Articles     Next Articles

Detection of bacterial endotoxin in paclitaxel liposome

Yusheng Pei, Tong Cai*, Guolai Zhang, Chen Chen, Hua Gao   

  1. National Institutes for Food and Drug Control, Beijing 102629, China
  • Received:2018-04-12 Revised:2018-05-03 Online:2018-06-30 Published:2018-05-30
  • Contact: Tel.:+86-010-53851594, E-mail: teddyct@163.com
  • Supported by:
    The National Major Scientific and Technological Special Project for “Significant New Drugs Development” of China (Grant No. 2015ZX09303001), Sub-task “study on methods for detection and evaluation of pyrogen substances in new preparations” (Grant No. 2015ZX093030012002).

Abstract:

Based on current research, there are three technologies during the test of bacterial endotoxin of liposomes: (1) extraction of bacterial endotoxin from liposomes; (2) addition of bacterial endotoxin in the process of recovery test; and (3) elimination of the interference factors from drugs and excipients. In the present study, we pointed out that the key technologies to test bacterial endotoxin from paclitaxel liposome included following steps: extraction of bacterial endotoxins from ethanol-dissolved liposomes; preparation of positive control of recovery solution by adding 0.01 mL standard endotoxins in 1 mL liposome ethanol solution; and the use of 0.5% human albumin to eliminate the interference from detection, and accurate detection of the bacterial endotoxin of liposomes.

Key words: Bacterial endotoxin test, Paclitaxel, Liposome, Drug delivery system

CLC Number: 

Supporting: