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质量控制分析方法:纯净水:用于配制药房的水净化系统和美国药典用水,第1部分。

Quality-control analytical methods: aqua pura: water purification systems and United States pharmacopeia waters for the compounding pharmacy, part 1.

作者信息

Latta Kenneth S, Cabaleiro Joe, Whitehead Paul, Edison Doug

机构信息

Duke University Medical Center Durham, North Carolina.

出版信息

Int J Pharm Compd. 2011 Mar-Apr;15(2):133-44.

PMID:23696083
Abstract

The types of water used most often in a compounding pharmacy are potable water, purified water, and sterile water (water for injection or irrigation). Of those three types, purified water is most frequently used; it is essential as a clean glassware rinse and is used in the compounding and reconstitution of frequently prescribed no sterile compounds, such as antibiotic suspensions. Using the appropriate water is absolutely essential to good compounding practice. Purified water cannot be substituted for sterile water for irrigation or injection, and if the last step in washing glassware and pharmaceutical implements is not a thorough purified-water rinse, the cross-contamination of preparations with drugs or chemicals (the presence of which can be missed even during potency testing) can occur. In this first of a series of three articles, we briefly review the types of United States Pharmacopeia water used most frequently in compounding, discuss the basic types of water purification systems that can be used in a compounding, discuss the basic types of water purification systems that can be used in a compounding pharmacy, and answer questions about water purification systems that are of interest to compounding pharmacists. Part 2 will provide current information from the United States Pharmacopeia about various waters, and part 3 will present testimonials from compounders who are using an in-house water purification system and additional information about water purification systems from manufacturers or vendors of that equipment (a Table comparing various water purification systems will be included for easy reference).

摘要

在配制药房中最常使用的水的类型有饮用水、纯化水和无菌水(注射用水或冲洗用水)。在这三种类型中,纯化水使用最为频繁;它对于清洗玻璃器皿至关重要,并且用于配制和复溶常用的非无菌化合物,如抗生素混悬液。使用合适的水对于良好的配制操作绝对至关重要。纯化水不能替代冲洗或注射用的无菌水,并且如果清洗玻璃器皿和制药器具的最后一步不是用纯化水彻底冲洗,制剂就可能会被药物或化学物质交叉污染(即使在效价检测期间也可能检测不到其存在)。在这三篇系列文章的第一篇中,我们简要回顾了配制中最常使用的美国药典规定的水的类型,讨论了可用于配制的水净化系统的基本类型,回答了配制药剂师感兴趣的关于水净化系统的问题。第2部分将提供美国药典关于各种水的最新信息,第3部分将展示使用内部水净化系统的配制人员的推荐意见以及该设备制造商或供应商提供的关于水净化系统的更多信息(将包含一个比较各种水净化系统的表格以便查阅)。

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