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甘露醇注射液为中国药典1995年版二部收载,其热原检查仍采用家兔法,但该方法影响因素较多。如家兔法检查甘露醇注射液中热原时,家兔易出现降温,而中国药典1995年版二部附录,对热原检查中结果的判断,家兔降温不作为合格与不合格的判断标准。曾在1986年,国家药典委员会对热原检查中家兔降温问题的处理意见中规定:“降温≤0.4℃为兔温正常波动范围以“0”计;降温值≥0.6℃需找原因重做
Mannitol injection for the Chinese Pharmacopoeia 1995 edition two contained, the pyrogen test is still using rabbit method, but the method of influencing factors. Such as rabbit law check the mannitol injection pyrogen, rabbits prone to cooling, and the Chinese Pharmacopoeia 1995 edition two appendix, pyrogen test results to determine the rabbit cooling is not as qualified and unqualified judgment . In 1986, the State Pharmacopoeia Commission on the pyrogen in the treatment of rabbits to deal with the issue of temperature control comments: “the temperature ≤ 0.4 ℃ for the rabbit temperature fluctuations in the normal range of” 0 "; cooling value ≥ 0.6 ℃ need to find the cause of redo