建立牛痘疫苗致炎兔皮提取物注射液的细菌内毒素检查法
Establishment of bacterial endotoxins test in extracts injection from rabbit skin inflamed by vaccinia virus
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摘要: 目的 建立牛痘疫苗致炎兔皮提取物注射液的细菌内毒素检查法。 方法 按照中国药典2010年版(二部)附录Ⅺ E细菌内毒素检查法进行干扰试验。 结果 牛痘疫苗致炎兔皮提取物注射液经100倍稀释后,用灵敏度λ为0.5 EU/ml的鲎试剂进行实验,供试品不干扰细菌内毒素检查。 结论 建立的牛痘疫苗致炎兔皮提取物注射液细菌内毒素检查可行。
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关键词:
- 细菌内毒素 /
- 鲎试剂 /
- 牛痘疫苗致炎兔皮提取物注射液 /
- 干扰试验
Abstract: Objective To establish a method for the detection of bacterial endotoxin in extracts injection from rabbit skin inflamed by vaccinia virus. Methods The interference test was carried out according to the guideline and procedure specified in appendix Ⅺ E, volume two, chinese pharmacopoeia 2010 edition. Results By using tachypleus amebocyte lysates which sensitivity was 0.5 EU/ml, the sample did not interfere with the bacterial endotoxins test when it was diluted 100 times. Conclusion The established method of bacterial endotoxins test for extracts injection from rabbit skin inflamed by vaccinia virus was feasible. -
[1] 中国药典2010版. 二部[S]. 2010. 附录99. [2] 中国药品生物制品检定所. 中国药品检验标准操作规范[M]. 北京: 中国医药科技出版社,2005: 287. [3] 高 锦,付 聪,嵇 扬,等. 复方氯解磷定注射液细菌内毒素的检查方法[J]. 药学实践杂志,2008,26(2):133. [4] 胡宇驰,杨赟昀,朱春玥,等. 醋酸戈舍瑞林缓释植入剂细菌内毒素检查方法学研究[J]. 药学实践杂志,2010,28(1):36. -
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