化學(xué)仿制藥口服溶液劑是可能豁免人體生物等效性研究的口服給藥劑型，其藥學(xué)研究關(guān)注點(diǎn)與口服固體制劑、注射劑等劑型均有一定差異，但目前國內(nèi)尚未出臺相關(guān)藥學(xué)研究技術(shù)指導(dǎo)原則。簡要介紹了化學(xué)仿制藥口服溶液劑藥學(xué)研究中需要關(guān)注的問題，包括處方工藝、質(zhì)量研究、穩(wěn)定性研究等方面，重點(diǎn)關(guān)注了微生物控制方面的內(nèi)容，結(jié)合審評實(shí)踐提出了研究建議；同時在國內(nèi)外相關(guān)法規(guī)要求的基礎(chǔ)上，探討了豁免人體生物等效性研究的相關(guān)要求。旨在為后續(xù)化學(xué)仿制藥口服溶液劑的藥學(xué)研究提供更多參考。

Oral solution generic drugs is an oral dosage form that the in vivo bioequivalence study may be waived, and its concerns on pharmaceutical study is different from oral solid generic drugs or injection, but there is no guideline for pharmaceutical study of oral solution in China. The concerns of the pharmaceutical study of oral solution generic drugs were briefly introduced, including formulation and manufacturing process, quality and stability studies,microbial control was focused in addition. Some suggestions were put forward based on the review practice, and the related requirements of biowaiver were discussed. In order to provide more references for the follow-up study on pharmaceutics of oral solution generic drugs.