經(jīng)腸內(nèi)飼管給藥的口服藥品的需求增多，但以往對(duì)此研究不夠深入細(xì)致，監(jiān)管力度也不大。為確保這種給藥方式安全有效，美國(guó)食品藥品管理局（FDA）于2021年6月發(fā)布了“經(jīng)腸內(nèi)飼管給藥的口服藥品：體外試驗(yàn)和說(shuō)明書(shū)建議”供企業(yè)用的指導(dǎo)原則。提出了臨床前體外試驗(yàn)的具體而詳細(xì)的建議，建議的試驗(yàn)類(lèi)型包括回收率試驗(yàn)、沉降量和再分散性試驗(yàn)、在指定分散介質(zhì)中的使用穩(wěn)定性試驗(yàn)、粒度分布研究、腸溶衣藥品的耐酸性試驗(yàn)和緩釋制劑溶出度試驗(yàn)。還提出了這類(lèi)給藥方式藥品說(shuō)明書(shū)的撰寫(xiě)建議，特別是給藥說(shuō)明的詳細(xì)建議并列舉了示例。我國(guó)目前還沒(méi)有類(lèi)似的指導(dǎo)原則，詳細(xì)介紹FDA該指導(dǎo)原則，供我國(guó)這方面的研究和監(jiān)管人員參考。以期將經(jīng)腸內(nèi)飼管給藥的口服藥品的體外試驗(yàn)和說(shuō)明書(shū)的撰寫(xiě)落到實(shí)處。

The demand for oral administration of drugs via enteral feeding tube is increasing, but the previous research on this is not deep and detailed, and the supervision is not strong. In order to ensure the safety and effectiveness of this administration method, FDA issued the Oral Drug Products Administered Via Enteral Feeding Tube:In Vitro Testing and Labeling Recommendations Guidance for Industry in June 2021. Specific and detailed recommendations for preclinical in vitro testing are put forward. The recommended testing types include recovery testing, sedimentation volume and redispersibility testing, in-use stability in designated dispersion media, particle size distribution study, acid resistance testing for dug products with an enteric coating and dissolution testing for extended-release drug products. It also puts forward recommendations on the writing of drug product labelings for this kind of administration, especially the detailed recommendations for administration instructions, and lists examples. At present, there is no similar guidance in China. This guidance of FDA is introduced in detail for the reference of researchers and regulators in this field. It is expected that the in vitro testing of oral drug products administered via enteral feeding tube and the writing of the drug product labeling will be implemented.

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