目的 比較分析我國與歐盟兒童非處方藥（OTC） （化學(xué)藥品單方制劑）相同活性成分對(duì)應(yīng)劑型與規(guī)格的異同，為我國兒童OTC（化學(xué)藥品單方制劑）適宜劑型和規(guī)格的科學(xué)補(bǔ)充與完善提供參考和建議。方法 檢索國家藥品監(jiān)督管理局（NMPA）官網(wǎng)，梳理出我國兒童OTC（化學(xué)藥品）清單，并從中篩選出單方制劑的活性成分；以篩選出的活性成分為檢索對(duì)象，從歐洲藥品管理局總部（HMA）官網(wǎng)、藥智網(wǎng)、藥物在線網(wǎng)站中檢索歐盟兒童OTC；采用描述性統(tǒng)計(jì)分析方法，比對(duì)我國與歐盟具有相同活性成分的兒童OTC（化學(xué)藥品單方制劑）劑型與規(guī)格的異同，為進(jìn)一步優(yōu)化我國兒童OTC提供借鑒。結(jié)果 我國兒童OTC（化學(xué)藥品單方制劑）對(duì)應(yīng)的活性成分共計(jì)72個(gè)，其中17個(gè)活性成分檢索到了歐盟兒童OTC單方制劑。對(duì)我國與歐盟17個(gè)相同活性成分對(duì)應(yīng)的劑型與規(guī)格進(jìn)行梳理。在劑型方面，歐盟兒童OTC中涉及劑型17種，其中獨(dú)有劑型4種，咀嚼膠囊為我國兒童OTC（化學(xué)藥品）缺失劑型；我國兒童OTC（化學(xué)藥品單方制劑）涉及劑型25種，其中獨(dú)有劑型13種。在規(guī)格方面，歐盟兒童OTC規(guī)格為53個(gè)，其中獨(dú)有規(guī)格33個(gè)；我國兒童OTC（化學(xué)藥品單方制劑）規(guī)格為90個(gè)，其中獨(dú)有規(guī)格70個(gè)。此外，少數(shù)活性成分對(duì)應(yīng)的劑型與規(guī)格在我國未納入兒童OTC，而歐盟已納入。結(jié)論 與歐盟相比，我國兒童OTC（化學(xué)藥品單方制劑）劑型與規(guī)格種類更加豐富，特別是口服固體制劑種類繁多；歐盟部分獨(dú)有劑型具有兒童使用優(yōu)勢，其獨(dú)有的單劑量包裝規(guī)格提高了兒童用藥安全性。我國相關(guān)部門應(yīng)借鑒歐盟先進(jìn)經(jīng)驗(yàn)，加大對(duì)兒童OTC適宜劑型與規(guī)格的開發(fā)。

Objective To compare and analyze the similarities and differences in the corresponding dosage forms and specifications of the same active ingredients in over-the-counter (OTC) (chemical single-ingredient preparation) for children between China and European Union, in order to provide reference and suggestions for the scientific supplementary opinions and improvement of suitable dosage forms and specifications for OTC (chemical single-ingredient preparation) for children in China. Methods The official website of the National Medical Products Administration (NMPA) was searched to sort out the list of OTC (chemical drugs) for children in China, and the active ingredients of single-ingredient preparation were screened from it; Using the screened active ingredients as the search object, EU children's OTC were searched from the European Medicines Agency (HMA), Yaozh website, and Drug future website; Using descriptive statistical analysis methods, the similarities and differences were compared in dosage forms and specifications of OTC (chemical single-ingredient preparation) for children with the same active ingredients between China and European Union, and provide reference for further optimizing OTC for children in China. Results There are 72 active ingredients of OTC (chemical drugs) single-ingredient preparation for children in China, of which 17 active ingredients were retrieved from OTC singleingredient preparation for children in European Union. Sort out the dosage forms and specifications corresponding to 17 identical active ingredients in China and European Union. In terms of dosage forms, 17 dosage forms are involved in these 17 active ingredients of OTC for children in European Union, including four exclusive dosage forms, and chewing capsules are lacking in OTC (chemical singleingredient preparation) for children in China; 25 dosage forms are involved in OTC (chemical single-ingredient preparation) for children in China, including 13 exclusive dosage forms. In terms of specifications, there are 53 drug specifications in European Union, including 33 unique specifications; There are 90 specifications in China, including 70 unique specifications. Dosage forms and specifications corresponding to a few active ingredients have not been included in OTC (chemical single-ingredient preparation) of children in China, while OTC (chemical single-ingredient preparation) of children in European Union has included them. Conclusion Compared to the European Union, China offers a more diverse range of OTC (chemical single-ingredient preparation) formulations and specifications for children, particularly with a wide variety of oral solid dosage forms. Some unique dosage forms in the European Union have advantages for children, and the unique single-dose packaging specifications improve the safety of pediatric drugs. Relevant departments in China can learn from the advanced experience of European Union and research more suitable dosage forms and specifications of OTC for children.

R283.6

中國非處方藥物協(xié)會(huì)自我藥療教育專業(yè)委員會(huì)課題（CMNASMEC-2021-03）