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葡萄糖酸氯己定中的有毒杂质

[Toxic impurities in chlorhexidine digluconate].

作者信息

Kohlbecker G

出版信息

Dtsch Zahnarztl Z. 1989 Apr;44(4):273-6.

PMID:2702165
Abstract

Three preparations of chlorhexidine-digluconate were analysed for contamination with a newly developed high-pressure liquid chromatographic method. Of special interest was p-chloroaniline, a toxic as well as a carcinogenic compound. We found concentrations from 1.7 to 8.5 mmol p-chloroaniline per mol chlorhexidine-digluconate, i.e. five-fold differences in the different products. Besides p-chloroaniline many other contaminating substances were found, amongst others p-chlorophenyl-isocyanate and p-chlorophenyl-carbodiimide. The least contamination was found in a branded article, and the highest degree of contamination in a "no-name"-product. During a storage period of half a year in dark glass bottles in a solution of 0.2% under various light and temperature values the p-chloroaniline concentrations increased linearly with the period of storage, with the exception of storage in the dark at 5 degrees C. A constant temperature of 35 degrees C in the dark caused a greater increase than storing at 20-25 degrees C in the dark or the light or in direct sunlight. Therefore under similar conditions it is mostly warmth which causes an increase in toxic compounds.

摘要

采用一种新开发的高效液相色谱法对三种葡萄糖酸氯己定制剂进行了污染分析。特别值得关注的是对氯苯胺,它是一种有毒且致癌的化合物。我们发现每摩尔葡萄糖酸氯己定中对氯苯胺的浓度为1.7至8.5毫摩尔,即不同产品之间相差五倍。除了对氯苯胺外,还发现了许多其他污染物,其中包括对氯苯基异氰酸酯和对氯苯基碳二亚胺。在一个品牌产品中发现的污染物最少,而在一个“无品牌”产品中污染程度最高。在0.2%的溶液中,于不同光照和温度条件下,在深色玻璃瓶中储存半年期间,除了在5摄氏度黑暗环境中储存外,对氯苯胺浓度随储存时间呈线性增加。在黑暗中35摄氏度恒温条件下导致的增加幅度大于在20 - 25摄氏度黑暗、光照或直射阳光下储存的情况。因此,在类似条件下,主要是温度导致有毒化合物增加。

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J Indian Soc Periodontol. 2012 Apr;16(2):213-7. doi: 10.4103/0972-124X.99264.
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Clin Microbiol Rev. 2004 Oct;17(4):863-93, table of contents. doi: 10.1128/CMR.17.4.863-893.2004.