华侨大学学报（自然科学版）2025，Vol.46Issue(6)：675-684,10.DOI:10.11830/ISSN.1000-5013.202503032
帕泊昔布仿制片的制备及体外溶出度的一致性考察
Preparation of Palbociclib Imitation Tablets and Investigation of In Vitro Dissolution Consistency
摘要
Abstract
The original formulation of palbociclib tablets was investigated and the consistency of the in vitro dissolution of palbociclib imitation tablets and reference tablets was examined.Referring to the original drug,palbociclib imitation tablets were prepared using direct compression method.The tablet formulation was deter-mined through single-factor experiments and in vitro dissolution method.An in vitro dissolution test was per-formed using high-performance liquid chromatography(HPLC)to evaluate the in vitro dissolution behavior of palbociclib imitation tablets.The palbociclib imitation tablets were compared with the reference tablets to eval-uate the similarity of their dissolution behavior in four different dissolution media.The results showed that the homemade palbociclib imitation tablet formulation met the relevant requirements for tablet quality specified in the pharmacopoeia.The HPLC method for detecting palbociclib in four dissolution media yielded linear correla-tion coefficients greater than 0.99,with objective and accurate measurement results and good recovery rates.The in vitro dissolution profiles of the palbociclib imitation tablets were similar to those of the reference tablets in four dissolution media,with f2 values all greater than 50.关键词
帕泊昔布仿制片剂/高效液相色谱(HPLC)法/体外溶出/一致性评价Key words
palbociclib imitation tablets/high-performance liquid chromatography(HPLC)/in vitro dissolu-tion/consistency evaluation分类
医药卫生引用本文复制引用
施城宇,薛凯琳,孙源培,赵健康,王立强,侯志勇..帕泊昔布仿制片的制备及体外溶出度的一致性考察[J].华侨大学学报（自然科学版）,2025,46(6):675-684,10.基金项目
国家重点研发计划项目(2016YFE0101700) （2016YFE0101700）
福建省高校产学合作重大项目(2019Y4007) （2019Y4007）
华侨大学研究生科研创新基金资助项目(18013071019) （18013071019）
