《美国药典》新通则<232>和<233>元素杂质控制新标准和方法介绍及其对医药界的影响  

New Standard and Method for Elemental Impurities Control in <232> and <233> New General Rules of USP and Effects of Them on Pharmaceutical Industry

作　　者：张慧敏[1] 余灵芝[1] 陈旭[1] 冯常强[1] 

机构地区：[1]浙江省台州医院药剂科,浙江临海317000

出　　处：《中国药房》2014年第17期1601-1604,共4页China Pharmacy

摘　　要：目的:介绍《美国药典》(USP)新通则<232>和<233>中的药品元素杂质控制的新标准和方法,并分析其对医药行业的影响。方法:与现行标准比较USP新通则中元素杂质控制的新标准和方法以及重金属检查法的异同,并分析各元素杂质定量检测方法的优缺点及运行成本,对相关生产厂家提出建议。结果与结论:新通则明确要求测定各元素杂质含量而不是总量,即由半定量转为定量控制,并规定了15种金属元素杂质的每日允许接触限值及原料药和辅料中元素杂质的限量值;新通则推荐的两种重金属检查分析方法为电感耦合等离子体原子发射光谱法和电感耦合等离子体质谱法,可大大提高杂质检出能力,但仪器总运行成本较高。准备进入美国市场或已有产品销售的原料药或制剂生产厂家需对检测分析手段从软件和硬件上进行升级,并开发和验证合适的金属杂质检测方法。新通则的实施能更好地控制药品中的元素杂质含量。OBJECTIVE： To introduce new standard and method for elemental impurities control in 〈232〉 and 〈233〉 new gen- eral roles of United States Pharmacopenia （USP）, and to analyze the effects of them on pharmaceutical industry. METHODS： The existing standard was compared with new standard and method for elemental impurities control and heavy metal tests in new gener- al rules of USE The characteristics and operating costs of quantitative detection methods for elemental impurities were analyzed to put forward the suggestions for relevant manufacturers. RESULTS ＆ CONCLUSIONS： New general rules clearly demanded that the content of each elemental impurity rather than total content of elemental impurity should be determined, in another word, semi- quantitative control changed into quantitative control; provided daily exposure limits of 15 elemental impurities and the limits of ele- mental impurities in raw materials and excipients. ICP-AES and ICP-MS were recommended methods for the determination of heavy metals; the detection ability had been improved greatly but they were more costly. The manufacturers, which are making ready to enter the USA market or have sold raw material and preparations in the market, should upgrade, develop and validate the detection method of metal impurity in fields of software and hardware. The implementation of new rules can control the contents of elemental impurity better.

关 键 词：美国药典 新通则 元素杂质 重金属检查 仪器分析 

分 类 号：R921[医药卫生—药学] R924