目的 為我國(guó)仿制藥參比制劑目錄的建立提供借鑒和參考。方法 簡(jiǎn)要介紹國(guó)內(nèi)外參比制劑的選擇要求，以《2018年底前須完成仿制藥一致性評(píng)價(jià)品種目錄》為基礎(chǔ)，匯總了世界衛(wèi)生組織（WHO）、美國(guó)橙皮書、日本橙皮書、國(guó)家食品藥品監(jiān)督管理總局（CFDA）等數(shù)據(jù)庫(kù)的參比制劑信息，并對(duì)289個(gè)待評(píng)價(jià)品種的參比制劑概況進(jìn)行總結(jié)。結(jié)果 289個(gè)參與一致性評(píng)價(jià)的品種中與國(guó)外參比制劑劑型規(guī)格均匹配的有126個(gè)，與國(guó)外的參比制劑的劑型或規(guī)格存在差異的有49個(gè)，國(guó)外沒有明確參比制劑的有89個(gè)。結(jié)論 由于匹配的參比制劑數(shù)目較少，參比制劑的選擇難度較大，因此政府要建立科學(xué)有效的評(píng)價(jià)指標(biāo)，相關(guān)企業(yè)也要主動(dòng)選擇參比制劑，主動(dòng)進(jìn)行對(duì)比研究，盡快推動(dòng)參比制劑目錄的確定。

Objective To provide references for the reference drug directory construction of generic drugs in China. Methods The selection of domestic and foreign reference preparation was introduced and information on reference preparation in WHO Orange Book, the US Orange Book, Japan Orange Book and CFDA databases was summaried, which based on the catalog past the consistency of the evaluation by the end of 2018. Results In the 289 varieties whitch involved in of consistency evaluation, there are 126 varieties found that match dosage form and strength in the foreigh reference drug. There are 49 varieties found that different with foreigh reference drug at dosage form or strength. And without a clear reference drug have 87 varieties. Conclusion It is more difficult to make a decision due to the less number of the reference drug. Therefore, the government should establish a scientific and effective evaluation index. The relevant enterprises should actively select and comparative study in the choice of reference drug and to promote the decision of reference drug directory as soon as possible.