化学仿制药口服溶液剂是可能豁免人体生物等效性研究的口服给药剂型，其药学研究关注点与口服固体制剂、注射剂等剂型均有一定差异，但目前国内尚未出台相关药学研究技术指导原则。简要介绍了化学仿制药口服溶液剂药学研究中需要关注的问题，包括处方工艺、质量研究、稳定性研究等方面，重点关注了微生物控制方面的内容，结合审评实践提出了研究建议；同时在国内外相关法规要求的基础上，探讨了豁免人体生物等效性研究的相关要求。旨在为后续化学仿制药口服溶液剂的药学研究提供更多参考。

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.