热原用兔敏感性检查方法的探讨

目的 通过热原用兔对细菌内毒素敏感性的调查，探讨用细菌内毒素检查热原检查用兔的可行性。方法 用国家颁发的细菌内毒素标准品，按中国药典2005年版二部附录“热原检查法”进行检查，剂量分别为5，10 EU·kg^-1，计算平均最大升温值和升温率(≥0.6 ℃)，并按中国药典阳性判断结果的标准进行判断。结果 细菌内毒素静脉注射5 EU·kg^-1，家兔平均最大升温值为0.50 ℃，升温率为55.0%，小于初试不合格的判断要求，大于复试后不合格的判断要求；细菌内毒素静脉注射10 EU·kg^-1，平均最大升温值为0.77 ℃，升温率为86%，均大于初试不合格的判断要求。结论 用静脉注射细菌内毒素的方法，可以对热原用家兔进行细菌内毒素敏感性检查，剂量5 EU·kg^-1可成为检查的限度剂量。

Inspection Method of the Sensitivity of Pyrogen Rabbits

OBJECTIVE To investigate the feasibility of the mehtod which tests the pyrogen rabbits with banterial endotoxin and study the sensitivity of pyrogen rabbits to bacterial endotoxin.METHODS Experiment was conducted according to pyrogen test in Ch.P（2005） Vol Ⅱ.Rabbits were administered by intravenous injection with different doses of bacterial endotoxin standard state（5,10 EU.kg-1）.Average maximum temperature value and temperature rise rate（≥0.6 ℃） were calculated and the results were judged by the positive results of the Ch.P standards.RESULTS When rabbits were administered by intravenous injection with dose of 5 EU.kg-1,average maximum temperature value of rabbits was 0.5 ℃ and temperature rise rate was 55.0%.The results were less than the first test failed to judge requriements and unqualified to judge more than re-testing requirements.When rabbits were administered by intravenous injection with dose of 10 EU.kg-1,average maximum temperature value of rabbits was 0.77 ℃ and temperature rise rate was 86.0%.The results were greater than the first test failed to judge requriements.CONCLUSION When rabbits were administered by intravenous injection with dose of 5 EU.kg-1 of bacterial endotoxin,we can test the sensitivity of pyrogen rabbits to bacterial endotoxin.The dose of 5 EU.kg-1 may be a checking limit dose.