注射用凍干制劑作為注射劑中的常用劑型之一，在藥品注冊(cè)申報(bào)中占較高比例。基于劑型特點(diǎn)、風(fēng)險(xiǎn)防范，梳理總結(jié)了注射用凍干制劑新藥申報(bào)中常見的藥學(xué)問(wèn)題，包括未進(jìn)行合理的滅菌或無(wú)菌工藝篩選與研究，未結(jié)合品種特點(diǎn)開展處方工藝開發(fā)，有關(guān)物質(zhì)分析方法的檢出能力研究不充分，配伍穩(wěn)定性、輸液管路相容性研究不全面等。結(jié)合相關(guān)行業(yè)指南及指導(dǎo)原則，從處方工藝開發(fā)、質(zhì)量研究、穩(wěn)定性研究等方面，闡述了注射用凍干制劑藥學(xué)審評(píng)的基本考慮，以期為該類制劑的研發(fā)申報(bào)和技術(shù)評(píng)價(jià)提供參考。

As one of the commonly used dosage forms in injection, lyophilized preparations for injection account for a high proportion in drug registration applications. Based on the characteristics of dosage forms and based on risks, this paper summarizes the common pharmaceutical problems of lyophilized preparations for injection in the new drug application. For example, the rationality of sterilization or aseptic process screening and research is insufficient, pharmaceutical development without considering the characteristics of the drug products, insufficient research on the detection ability of related substances analysis methods, incomplete research on compatibility stability and infusion pipeline compatibility, etc. Combining relevant industry guidelines and guidances, the basic considerations for pharmaceutical evaluation of freeze-dried formulations for injection were elaborated from the aspects of pharmaceutical development, quality studies, stability studies, etc, in order to provide reference for the research and development of such preparations.

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