常释、缓释、迟释在中美欧中的翻译到底应该是什么呢?Immediate\Extended\Delayed-release)

Immediate release 到底是不是速释呢?

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?

USP中的定义

  • 首先来看USP<1151>对Immediate-release(IR)的定义:observed when nodeliberate effort has been made to modify the drug substance release profile.即没有故意修饰药物的释放,比如使用崩解剂或润滑剂的胶囊和片剂,也被认为是Immediate release的。

EEP中的定义

  • 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。

中国药典的定义

  • 中国药典四部<9013>只有缓释、控释和迟释制剂的定义。
  • 根据CDE发布的<以药动学参数为终点评价指标的化学药物仿制药人体生物等效性研究技术指导原则>其中提到的 口服常释制剂即对应FDA指南BioequivalenceStudies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA中的Immediate-release。

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<1151>:

  • 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<9013>缓释、控释和迟释制剂指导原则的定义:

  • 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

FDAEUNMPA
Immediate-releaseConventional-release/Immediate-release常释
Modified-releaseModified-release调释
Extended-releaseProlonged-release/Extended-release缓释
Delayed-releaseDelayed-release迟释

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