| 复方乳酸钠山梨醇注射液细菌内毒素检查法的研究 |
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| 引用本文： | 王慧玉,蒋小君,潘太彬. 复方乳酸钠山梨醇注射液细菌内毒素检查法的研究[J]. 海峡药学, 2010, 22(8): 79-80 |
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| 作者姓名： | 王慧玉 蒋小君 潘太彬 |
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| 作者单位： | 浙江省丽水市中医院,丽水,323000;浙江济民制药有限公司,台州,318020;浙江省台州市黄岩区第三人民医院,台州,318020 |
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| 摘 要： | 目的通过复方乳酸钠山梨醇注射液细菌内毒素检查（BET）的干扰实验,建立用细菌内毒素检查法代替家兔法检查热原。方法根据《中国药典》2005年版二部收载的细菌内毒素法的要求进行实验。结果将复方乳酸钠山梨醇注射液经2倍稀释可消除干扰,可用标示灵敏度0．25EU·mL^-1的鲎试剂检测样品中的细菌内毒素。结论可以用细菌内毒素检查法代替家兔法来控制复方乳酸钠山梨醇注射液的质量。
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| 关 键 词： | 复方乳酸钠山梨醇注射液 细菌内毒素 热原 |
Study of testing method of bacterial toxin in compound sodium lactate and sorbitol injection |
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| WANG Hui-yu,JIANG Xiao-jun,PAN Tai-bin. Study of testing method of bacterial toxin in compound sodium lactate and sorbitol injection[J]. Strait Pharmaceutical Journal, 2010, 22(8): 79-80 |
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| Authors: | WANG Hui-yu JIANG Xiao-jun PAN Tai-bin |
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| Affiliation: | 1. Zhejiang Lishui Chinese Medicine hospital Lishui 323000,China; 2. Zhejiang Chimin Pharmaceutical Co., Ltd. Taizhou 318020, China; 3. Zhejiang Taizhou Huangyan third people of hospital Taizhou 318020, China) |
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| Abstract: | OBJECTIVE Through the compound sodium lactate sorbitol injection bacterial endotoxin test （BET）of the interference experiment with the establishment of bacterial endotoxin test instead of the original inspection of rabbits. METHODS According to the ＂Chinese Pharmacopoeia＂ 2005 version 2 contains the bacterialtoxin at the request of law. RESULTS Will compound sodium lactate sorbitol injection can be diluted by 2 times to eliminate interference, can be marked sensitivity of 0.25 EU· mL^- 1 of the TAL testing samples of bacterial toxins. CONCLUSION Bacterial toxin can be used instead of rabbit test compound of sodium lactate to control the quality of sorbitol injection. |
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| Keywords: | Compound sodium lactate sorbitol injection bacterial toxin pyrogen |
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