经肠内饲管给药的口服药品的需求增多，但以往对此研究不够深入细致，监管力度也不大。为确保这种给药方式安全有效，美国食品药品管理局（FDA）于2021年6月发布了“经肠内饲管给药的口服药品：体外试验和说明书建议”供企业用的指导原则。提出了临床前体外试验的具体而详细的建议，建议的试验类型包括回收率试验、沉降量和再分散性试验、在指定分散介质中的使用稳定性试验、粒度分布研究、肠溶衣药品的耐酸性试验和缓释制剂溶出度试验。还提出了这类给药方式药品说明书的撰写建议，特别是给药说明的详细建议并列举了示例。我国目前还没有类似的指导原则，详细介绍FDA该指导原则，供我国这方面的研究和监管人员参考。以期将经肠内饲管给药的口服药品的体外试验和说明书的撰写落到实处。

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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