Immediate release 到底是不是速释呢?

发布日期:2020-09-29

Immediate release在业内多年来一直被默认为是速释,那么欧美到底是怎么定义Immediate release的呢?对应国内的准确翻译到底应该是什么呢?

  • 首先来看USP

  • EP Glossary中对Immediate-release(也叫Conventional-release)的定义:a release of active substance(s) that is not deliberately modified by aspecial formulation design and/or manufacturing method. 即未采用特殊处方设计和/或生产方法故意修饰的药物释放。

  • 中国药典四部

  • 根据CDE发布的

因此,Immediate-release在国内对应的翻译是常释。而常释剂型里面只有满足15分钟内API的溶出达到标示量的85%以上才叫快速溶出。

划重点

常释剂型并不全是快速溶出哦,所以Immediate release翻译为速释是不准确的。以后看到Immediate-release(IR)不要再叫“速释”啦,CDE的官方翻译是“常释”。

知识小拓展

缓释,迟释在各国药典的定义:

1. USP

  • Modified-release:when the rateand/or time of release of the drug substance is altered as compared to whatwould be observed or anticipated for an immediate-release product. Two modified-releaseprofiles, delayed-release and extended-release, are recognized.与IR剂型相比,药物释放的速率和/或时间有所改变。MR包含delayed-release和extended-release。

  • Extended-release:when thedeliberate formulation achieves prolongation of drug substance release comparedto that observed or anticipated for an immediate-release dosage form. 与IR剂型相比,有意的改变处方实现药物释放的延长

  • Delayed-release:when deliberateformulation achieves a delay in the release of the drug substance for someperiod of time after initial administration. 即有意改变处方实现首次给药后一段时间内药物延迟释放

2.EP Glossary 

  • Prolonged-release:is amodified-release dosage form showing a slower release of active substance(s)than that of a conventional-release dosage form administered by the same route.Prolonged release is achieved by a special formulationdesign and/or manufacturing method. Equivalent term: extended-release dosageform.缓释剂型是调释剂型的一种,在相同给药途径下,与常规释放剂型相比,药物释放缓慢。通过特殊的处方设计和/或生产方法可以实现缓慢释放。等同术语:extended-release.

  • Delayed-release:is amodified-release dosage form, usually administered orally, where the onset ofrelease of the active substance(s) is adjusted to take place after a specifictime or at a specific location in the gastrointestinal tract. Delayed releaseis achieved by a special formulation design and/ormanufacturing method.迟释剂型是调释剂型的一种,通常口服给药,将药物的释放调整为在特定时间后或在胃肠道中的特定位置发生。通过特殊的处方设计和/或生产方法可以实现延迟释放

3.中国药典2020年版四部

  • 缓释制剂,系指在规定的释放介质中,按要求缓慢地非恒速释放药物,与相应的普通制剂比较,给药频率减少一半或有所减少,且能显著增加患者用药依从性的制剂。

  • 控释制剂,系指在规定的释放介质中,按要求缓慢地恒速释放药物,与相应的普通制剂比较,给药频率减少一半或有所减少,血药浓度比缓释制剂更加平稳,且能显著增加患者用药依从性的制剂。

  • 迟释制剂,系指在给药后不立即释放药物的制剂,包括肠溶制剂、结肠定位制剂和脉冲制剂等。

综上,Modified-release对应翻译是调释,Extended-release/Prolonged-release是缓释,Delayed-release是迟释。

知识点总结如下

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