定量检测茵栀黄注射液细菌内毒素方法的建立及应用
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摘要
目的建立茵栀黄注射液中细菌内毒素的定量检测方法,与家兔法热原检测结果相比较,以确定动态显色基质法用于茵栀黄注射液中细菌内毒素定量检测的可行性。方法采用光度法中的动态显色基质法对茵栀黄注射液进行干扰试验,以明确供试品对动态显色法鲎试剂是否有干扰作用,确立不干扰浓度,并与家兔法热原检测结果相比较。结果使用动态显色法鲎试剂对茵栀黄注射液稀释至37.5倍时无干扰作用,回收率为50%～200%;家兔法检查3批茵栀黄注射液热原结果均符合规定,动态显色法与家兔法检查结果一致。结论动态显色基质法用于茵栀黄注射液中细菌内毒素含量的定量检测是可行的,相较于家兔法热原检查,其结果更稳定可靠,操作方便快捷,灵敏度高。
Objective To establish a quantitative detection method for bacterial endotoxin in Yinzhihuang Injection, which was compared with the rabbit pyrogen test results, so as to determine the feasibility of dynamic chromogenic matrix method for quantitative detection of bacterial endotoxin in Yinzhihuang Injection. Methods Dynamic chromogenic matrix reagent in spectrophotometry was used to interfere Yinzhihuang Injection, determine whether the test article had a disturbing effect on horseshoe crab agent of dynamic chromogenic matrix method, also used to determine non-interference concentration and compared with rabbit pyrogen test results. Results Dynamic chromogenic matrix method was used to detect the endotoxin in Yinzhihuang Injection with 37.5-fold diluted concentration, the recovery rates was within 50%-200%, and pyrogenous results of 3 batches of Yinzhihuang Injection by rabbit method test were in line with the provisions. Dynamic chromogenic matrix method was consistent with the inspection result of rabbit method. Conclusion It is feasible for the quantitative detection of bacterial endotoxin content in Yinzhihuang Injection by dynamic chromogenic matrix method. Compared to the rabbit pyrogen test, the result is more stable and reliable, with the advantages of convenient operation and high sensitivity.
Objective To establish a quantitative detection method for bacterial endotoxin in Yinzhihuang Injection, which was compared with the rabbit pyrogen test results, so as to determine the feasibility of dynamic chromogenic matrix method for quantitative detection of bacterial endotoxin in Yinzhihuang Injection. Methods Dynamic chromogenic matrix reagent in spectrophotometry was used to interfere Yinzhihuang Injection, determine whether the test article had a disturbing effect on horseshoe crab agent of dynamic chromogenic matrix method, also used to determine non-interference concentration and compared with rabbit pyrogen test results. Results Dynamic chromogenic matrix method was used to detect the endotoxin in Yinzhihuang Injection with 37.5-fold diluted concentration, the recovery rates was within 50%-200%, and pyrogenous results of 3 batches of Yinzhihuang Injection by rabbit method test were in line with the provisions. Dynamic chromogenic matrix method was consistent with the inspection result of rabbit method. Conclusion It is feasible for the quantitative detection of bacterial endotoxin content in Yinzhihuang Injection by dynamic chromogenic matrix method. Compared to the rabbit pyrogen test, the result is more stable and reliable, with the advantages of convenient operation and high sensitivity.
引文
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[12] 张玉臣. 茵栀黄注射液细菌内毒素的检测[J]. 西北药学杂志, 2008, 23(5): 314-315.
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[15] 董艳丽, 刘峰, 曹桂敏. 灯盏花素注射液细菌内毒素检查法的研究[J]. 中国医药导报, 2007, 4(5): 124-124.
[2] 孙哲. 细菌内毒素检验[J]. 世界最新医学信息文摘, 2012, 12(9): 128-130.
[3] 汤秋华. 动态浊度法测定血液透析液的细菌内毒素含量[J]. 海峡药学, 2013, 25(9): 76-78.
[4] 陈秀强, 韦曦, 刘丽珍, 等. 血液透析用水及透析液质量监测结果分析[J]. 中华医院感染学杂志, 2012, 22(3): 550-551.
[5] Hirata N, Yanaqawa Y, Satoh M, et al. Dendritic cell-derived TNF-alpha is responsible for development of IL-10-producing CD4 + T cells[J]. Cell Immunol, 2010, 261(1): 37-41.
[6] Newby AC. Metalloproteinase expression in monocytes and macrophages and its relationship to atheroselerotic plaque instability[J]. Arterioscler Thremb Vasc Biol, 2008, 28(12): 2108-2114.
[7] 邵英光, 李京华, 魏桂林, 等. 内毒素的去除策略[J]. 广州化学, 2003, 28(2): 38-45.
[8] 宋晓坤, 李利娟. 5种中药注射液细菌内毒素检测方法的建立[J]. 中草药, 2006, 37(12): 1819-1821.
[9] 郝然, 刘婷, 易艳, 等. 动态浊度法检测5种中药注射液的内毒素含量[J]. 中国实验方剂学杂志, 2011, 17(24): 120-123.
[10] 曹春雨, 刘婷. 显色基质法检测6种中药注射液内毒素含量[J]. 中国实验方剂学杂志, 2010, 16(9): 88-91.
[11] 王梅娟. 动态浊度法定量检测茵栀黄注射液中细菌内毒素[J]. 现代中西医结合杂志, 2010, 19(10): 1249-1250.
[12] 张玉臣. 茵栀黄注射液细菌内毒素的检测[J]. 西北药学杂志, 2008, 23(5): 314-315.
[13] 国家药典委员会. 中华人民共和国药典(四部)[M]. 北京: 中国医药科技出版社, 2015: 154-157.
[14] 中华人民共和国卫生部药典委员会. WS 3-B-2736-97 中华人民共和国卫生部药品标准中药成方制剂第十四册[S]. 北京: 人民卫生出版社, 1997.
[15] 董艳丽, 刘峰, 曹桂敏. 灯盏花素注射液细菌内毒素检查法的研究[J]. 中国医药导报, 2007, 4(5): 124-124.