氨磷汀水分测定方法比较
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[摘要] 目的:比较干燥失重法、卡氏法、减压干燥法、甲苯法四种方法测定氨磷汀结晶水含量的效果。方法:分别用上述四种方法测定氨磷汀结晶水含量,并对结果进行比较。结果:氨磷汀样品不能采用干燥失重法测定水分。80℃减压干燥法,虽然干燥前后样品有关物质没有明显变化,但12 h之内并不能完全将结晶水从样品中分离出来。甲苯法所需求的样品量过大,且甲苯对人体伤害较大。卡氏法能够较好地测定氨磷汀三水化合物的水分。结论:卡氏法测定氨磷汀三水化合物的水分需要样品量小、检测时间短、操作简便。
[关键词] 氨磷汀;水分测定;方法
[中图分类号] R286.0 [文献标识码]B [文章编号]1674-4721(2010)06(a)-061-02
The comparision of moisture determination methods in amifostine
LI Hong, CHEN Xingyu, LI Yuefen
(The Second People's Hospital of Liangshan Prefecture,Xichang615000,China)
[Abstract] Objective:To compare the effect of using four methods including the loss on drying method, Carclan method, drying under reduced pressure method ,and methyl benzene, to determine the crystal water content in amifostine. Methods:The above-mentioned four methods were adopted to determine the level ofcrystal water content in amifostine and the results were compared. Results: The results were analyzed and compared. Amifostine samples can not be determined by loss on drying moisture. 80℃ vacuum drying, although the material in the samples did not change before and after drying, but within 12 hours of crystal water could not completely separate from the sample.Toluene method needed a large of samples and impact on human health greatly. The level of moisture content in amifostine thihydrate could be tested by the Carclan method. Conclusion: The Cartesian method has some advantages such as less in sample size,the testing time is short, easy to operate.
[Key words] Amifostine; Moisture determination; Methods
氨磷汀(amifostine)化学名为顺-[2-(3-氨丙基)胺乙基]二氢硫代磷酸三水化合物,分子式为C5H15N2O3PS·3H2O,为正常细胞保护剂,临床上主要用于各种癌症的辅助治疗。在对肺癌、卵巢癌、乳腺癌、鼻咽癌、骨肿瘤、消化道肿瘤、血液系统肿瘤等多种癌症患者进行化疗前应用本品,可明显减轻化疗药物所产生的肾脏、骨髓、心脏、耳及神经系统的毒性,而不降低化疗药物的药效。本品理论含水量为20.15%,美国药典27版规定其含水分应在19.2%～21.2%,故须对水分进行严格控制,本试验采用4种方法对3批氨磷汀进行了测定,并进行比较。
1材料与方法
1.1干燥失重法
1.1.1仪器及试剂DZF-6021减压干燥箱,DT100B电子分析天平、氨磷汀AS-20090812、AS-20090813、AS-20090814、氨磷汀标准品(本实验室3次精制标定)。
1.1.2试验方法参照中国药典(附录Ⅷ L干燥失重测定方法)操作,试验条件为常压、温度105℃。
1.2 减压干燥法
1.2.1仪器及试剂 DZF-6021减压干燥箱,DT100B电子分析天平,1M/TCJ24-JP-120H真空泵,五氧化二磷(AR)、氨磷汀AS-20090812、AS-20090813、AS-20090814、氨磷汀标准品(本实验室3次精制标定)。
1.2.2试验方法 参照中国药典(附录Ⅷ L干燥失重测定方法)操作,本品对热不稳定故试验条件控制在压力小于10mmHg、温度选择60、80℃两个温度点。
1.3 甲苯法
1.3.1仪器及试剂中国药典(附录ⅧM水分测定法 第二法)测定玻璃仪器1组、甲苯(AR)、氨磷汀AS-20090812、AS-20090813、AS-20090814、氨磷汀标准品(本实验室3次精制标定) ......
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