| 对杏丁注射液热原检查质量标准的修订研究 |
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| 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. |
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| 作者姓名： | 唐继坤 徐道华 潘正兴 黄武光 |
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| 作者单位： | 贵州省药品检验所,贵阳,550004 |
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| 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。
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| 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 |
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| Authors: | Tang Jikun Xu Daohu Pan Zhengxing and Huang Wuguang |
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| Institution: | 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 |
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| 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. |
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| Keywords: | xingding injection test for pyrogen standard revision |
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