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对杏丁注射液热原检查质量标准的修订研究
引用本文:唐继坤,徐道华,潘正兴,黄武光. 对杏丁注射液热原检查质量标准的修订研究[J]. 中国药品标准, 2002, 3(2): 27-28
作者姓名:唐继坤  徐道华  潘正兴  黄武光
作者单位:贵州省药品检验所,贵阳,550004
摘    要:目的:对杏丁注射液质量标准热原检查项进行修订。方法:采用《中国药典》2000年版二部附录XID“热原检查法”。结果:按人用量4.5倍剂量,用原药液及10%葡萄糖注射液稀释一倍后分别进行实验,3h内均有严重降温现象;按人用量3倍剂量,不管稀释与否,降温均得到明显改善;按人用量的2.25倍剂量,用10%葡萄糖注射液稀释一倍后实验,降温改善更明显。结论:建议将标准修订为,用10%葡萄糖注射液稀释一倍后,按家兔每1kg体重静脉缓慢注射3ml,应符合规定。

关 键 词:杏丁注射液 热原检查 标准修订

STUDY ON THE STANDARD OF TEST FOR PYROGEN OF XINGDING INJECTION
Tang Jikun,Xu Daohu,Pan Zhengxing and Huang Wuguang. STUDY ON THE STANDARD OF TEST FOR PYROGEN OF XINGDING INJECTION[J]. , 2002, 3(2): 27-28
Authors:Tang Jikun  Xu Daohu  Pan Zhengxing  Huang Wuguang
Affiliation:Guizhou Provincal Institute for Drug Control, Guiyang 550004;Guizhou Provincal Institute for Drug Control, Guiyang 550004;Guizhou Provincal Institute for Drug Control, Guiyang 550004;Guizhou Provincal Institute for Drug Control, Guiyang 550004
Abstract:Objective: To revise the standard of test for pyrogen of xingding injection.Method: Test for pyrogen method of the Chinese pharmacopocia 2000 was used.Result: The temperature seriously decreased in three hours in dosage of 4.5 times of the human and the temperature decrease was improved significantly in dosage of 3 times of the human when crude drug and dilution were given respectively.The temperature decrease was improved much more in dosage of 2.25 times of the human.Conclusion: The standard should be resived to use per kg of the rabbits weight 3ml dilution having been diluted one time by 10% glucose injection to inject vein slowly.
Keywords:xingding injection  test for pyrogen  standard revision  
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