标题: USP想要大大扩展眼科制剂<771>的内容 [打印本页] 作者: xiaoxiao 时间: 2015-10-19 09:23 PM 标题: USP想要大大扩展眼科制剂<771>的内容 20151014 ECA新闻：USP想要大大扩展眼科制剂<771>的内容
USP wants to considerably expand the Monograph for Ophthalmic Preparations <771>
USP想要大大扩展眼科制剂<771>的内容
The considerably expanded draft monograph <771> in the American pharmacopeia includes topical ophthalmic products like eye drops as well as ophthalmic preparations for injection purposes. These products are manufactured using terminal sterilisation, sterile filtration and aseptic filtration. An overview lists and describes the different pharmaceutical forms in more detail: solutions, suspensions, ointments, gels, emulsions, strips, injections, inserts and implants. However, the part on product quality is particularly interesting, especially the general tests. According to this, all ophthalmic preparations are to undergo a test to determine the integrity of the packaging and to test for visible particles. A 100% test is only mentioned for ophthalmic preparations for injections in transparent containers. If this is not possible due to the characteristics of the containers, reference is made to random sample tests in monograph <790>. The requirements with regard to subvisible particles are depending on the route of adminstration: According to the draft, products for intraocular use are to correspond with the the monograph Particulate Matter in Ophthalmic Solutions <789>, products for extraocular use should comply with the monograph Particulate Matter in Injections <788>.
USP中大大扩展的眼科制剂各论<771>包括了局部眼药，像滴眼液，以及眼用注射剂。这些药品采用了最终灭菌、无菌过滤和灭菌过滤方法来生产。其中列出并描述了不同剂型详细的内容：溶液、混悬液、膏剂、胶、乳剂、注射剂、插入和植入物。药品的质量部分非常有意思，尤其是常规测试。据此，所有眼用制剂都要经过一个测试来确定包装的完整性，测试可见颗粒。100%测试只有在透明容器中的注射用眼剂里提到了。如果因为容器的特性而无法实施的话，则要根据各论<790>随机取样测试。关于不可见颗粒物的要求取决于摄入途径：根据草案，眼内用制剂要符合眼用溶液内颗粒物<789>的要求，眼外用制剂则要符合注射剂内颗粒物<788>的要求。
The inclusion of a limit value for invisible particles in ophthalmic preparations is currently being discussed in Europe, too. You can find information on the discussion of expanding monograph 1163 on the EDQM homepage.
眼用制剂里的不可见颗粒物的限度值目前在欧洲也正在讨论中。你可以在EDQM官网首页对各论1163的讨论中找到相关信息。
Further sections in the USP monograph discuss sterility, preservatives and endotoxins (in injectable products). The requirements described for leachables/extractables that may come from the packaging are also new. It is pointed out that a risk assessment of leachables/extractables is not easy to perform, as there is little data about substances that can be absorbed via the eye. Therefore, data that has been determined for other routes of administration can be used for the risk analysis.
USP各论中还有内容也讨论了无菌性、防腐剂和内毒素（注射剂中）。新的内容还有来自包材的可浸出物/可萃出物要求。其中指出可浸出物/可萃出物的风险评估并不易实施，因为只有很少的关于可能通过眼睛吸收的物质的数据。因此，其它给药途径中所得到的数据可以用于风险分析。
Furthermore, the special tests that may be relevant for ophthalmic preparations are listed, such as viscosity, particle size distribution (in suspensions/emulsions) and drop size.
另外，其中还列出了可能与眼用制剂有关的特殊测试，例如，粘度、粒径分布（在混悬液/乳剂）和液滴大小。
The planned changes to monograph <771> can be found in the Pharmacopeial Forum. Access is free, all you have to do is register once free of charge. Comments may be submitted until 30 November 2015.
各论<771>计划的变更可以在药典论坛找到。登录是免费的，你只要进行免费注册就可以了。征求意见截止日期为2015年11月30日。