刺五加注射液致敏物质检测及去除方法

Methods of the Test and the Elimination of Bacterial Endotoxin in Ciwujia Injection

为探讨刺五加注射液中致敏物质的检测方法及去除手段,采用间接酶联免疫吸附试验(ELISA法)检测刺五加注射液中的致敏物质,同时考察超滤工艺对刺五加注射液大分子物质的截留效果。结果表明,被检测的3个厂家的刺五加注射液中致敏物质均在规定限度内,各含量无显著性差异;分子量为10 000 D的超滤膜能够显著截留刺五加注射液中的致敏物质。研究认为,间接ELISA法可以检测刺五加注射液中的致敏物质,超滤技术能够有效地去除刺五加注射液中的致敏物质。本研究不但提供了检测刺五加注射液中致敏物质含量的参考方法,还探讨了利用超滤技术去除中药注射液致敏物质的技术手段,从而为刺五加注射液生产工艺的改进提供了新的思路。

This experiment was conducted to research the methods of measurement and elimination of bacterial endotoxin in ciwujia injection by using ultrafiltration.The ELISA was used to determine the content of bacterial endotoxin of ciwujia injection and the sorption effect of ultrafiltration on ciwujia injection was measured.The results showed that the bacterial endotoxin in ciwujia injections from three different companies were within the limit of Chinese standard.No significant difference of contents was found among the three groups.The bacterial endotoxin of ciwujia injection was significantly eliminated by 10 000 dalton ultrafitration.The results suggest that ELISA method can be used to determine the bacterial endotoxin in ciwujia injections and Ultrafiltration technology can effectively eliminate the bacterial endotoxin of ciwujia injection.The results of the present study not only supplied the methods to determine the concentration of the endotoxin in ciwujia injection,but also found the technical way to eliminate the bacterial endotoxin in ciwujia injection by using ultrafiltration,which could supply some new ideas about how to improve the technology in the production of ciwujia injection.