緩控釋微丸膠囊是常見的緩控釋制劑，已逐漸成為緩控釋制劑研究開發(fā)的熱點(diǎn)之一。緩控釋微丸膠囊處方工藝研究是否充分，不僅是保證藥品質(zhì)量的基本前提，還是滿足臨床用藥的基礎(chǔ)。原輔料控制全面、處方設(shè)計(jì)合理、生產(chǎn)工藝穩(wěn)定重現(xiàn)等是處方工藝研究的重點(diǎn)?；趪H人用藥品注冊技術(shù)協(xié)調(diào)會(huì)指導(dǎo)原則和國內(nèi)外相關(guān)文獻(xiàn)以及審評中接觸到的實(shí)際案例，并結(jié)合緩控釋微丸膠囊制劑特點(diǎn)，圍繞緩控釋微丸膠囊處方工藝研究關(guān)注點(diǎn)，提出處方工藝開發(fā)過程中的一般考慮，以期為緩控釋微丸制劑的研究和注冊申報(bào)提供思路和建議。

Extended and controlled release micropill capsules is common sustained-release preparations, and have gradually become one of the hotspots in the research and development of sustained-release preparations. Whether the research on the formulation process of extended and controlled release micropill is sufficient is not only a basic prerequisite for ensuring drug quality, but also a foundation for meeting clinical needs. Comprehensive control of raw materials and auxiliary materials, rational prescription design, and stable and reproducible production processes are the focus of prescription process research. Based on the guiding principles of The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), relevant domestic and foreign literature, as well as actual cases encountered in reviews, and combined with the characteristics of extended and controlled release micropill capsules, this article focuses on the research focus of extended and controlled release micropill capsules formulation technology, and proposes general considerations in the formulation process development, in order to provide ideas and suggestions for the research and registration application of extended and controlled release micropill capsules.

R285.5