| 脑蛋白水解物注射液的生物安全性研究 |
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| 引用本文： | 肖贵南,陈琪,孙清萍,盛英美.脑蛋白水解物注射液的生物安全性研究[J].中国医药导报,2012,9(7):105-106. |
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| 作者姓名： | 肖贵南 陈琪 孙清萍 盛英美 |
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| 作者单位： | 广东省药品检验所,广东广州,510180 |
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| 基金项目： | 广东省食品药品监管局药检系统课题 |
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| 摘 要： | 目的研究脑蛋白水解物注射液的生物安全性。方法对过敏反应、异常毒性、降压物质等非标准收载项目以及细菌内毒素等标准项目进行研究分析,结果用于评价脑蛋白水解物注射液的生物安全性。结果按照设计的质量标准进行检查,1批样品出现了过敏反应,6批样品出现了降压反应,其余样品符合标准要求。结论需要进一步关注脑蛋白水解物注射液的生物安全性问题。
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| 关 键 词： | 脑蛋白水解物注射液 生物安全性 检查 |
Study on biological safety of Cerebroprotein Hydrolysate Injection |
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| XIAO Guinan
,
CHEN Qi SUN
,
Qingping
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SHENG Yingmei.Study on biological safety of Cerebroprotein Hydrolysate Injection[J].China Medical Herald,2012,9(7):105-106. |
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| Authors: | XIAO Guinan CHEN Qi SUN Qingping SHENG Yingmei |
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| Institution: | Guangdong Institute for Drug Control,Guangdong Province,Guangzhou 510180,China |
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| Abstract: | Objective To study the biological safety of Cerebroprotein Hydrolysate Injection(CHI).Methods The non-standard subject of test for allergic reaction,test for abnormal toxicity,test for depressor substances and standard subject of test for bacterial endotoxins were carried out to evaluate the biological safety of CHI.Results According to the designed quality standard,allergic reaction occurred in one batch of CHI and depressor reaction occurred in 6 batches of CHI,other batches of CHI conformed the requirements of standard.Conclusion It needs to pay more attention to the biological safety of CHI. |
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| Keywords: | Cerebroprotein Hydrolysate Injection Biological safety Test |
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