[1]施城宇,薛凯琳,孙源培,等.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.[doi:10.11830/ISSN.1000-5013.202503032]
　SHI Chengyu,XUE Kailin,SUN Yuanpei,et al.Preparation of Palbociclib Imitation Tablets and Investigation of In Vitro Dissolution Consistency[J].Journal of Huaqiao University(Natural Science),2025,46(6):675-684.[doi:10.11830/ISSN.1000-5013.202503032]
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帕泊昔布仿制片的制备及体外溶出度的一致性考察()
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《华侨大学学报（自然科学版）》[ISSN:1000-5013/CN:35-1079/N]

卷:
第46卷
期数:
2025年第6期
页码:
675-684
栏目:
出版日期:
2025-11-20

文章信息/Info

Title:
Preparation of Palbociclib Imitation Tablets and Investigation of In Vitro Dissolution Consistency
文章编号:
1000-5013(2025)06-0675-10
作者:
施城宇1;  薛凯琳1;  孙源培1;  赵健康1;  王立强1;  侯志勇1; 2
1. 华侨大学 生物医学学院, 福建 泉州 362021;2. 中国人民解放军联勤保障部队第 962 医院, 黑龙江 哈尔滨 150080
Author(s):
SHI Chengyu1;  XUE Kailin1;  SUN Yuanpei1;  ZHAO Jiankang1;  WANG Liqiang1;  HOU Zhiyong1; 2
1. School of Biomedical Sciences, Huaqiao University, Quanzhou 362021, China; 2. No. 962 Hospital of the Joint Logistic Support Force of the Chinese People’s Liberation Army, Harbin 150080, China
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
Keywords:
palbociclib imitation tablets;  high-performance liquid chromatography(HPLC);  in vitro dissolution;  consistency evaluation
分类号:
R944.4
DOI:
10.11830/ISSN.1000-5013.202503032
文献标志码:
A
摘要:
探究帕泊昔布片剂的原研处方并对帕泊昔布仿制片剂与参比片剂的体外溶出度一致性进行考察。参照原研药品,利用直接压片法制备帕泊昔布仿制片,通过单因素实验与体外溶出度法确定片剂处方;采用高效液相色谱(HPLC)法开展体外溶出度试验,以评价帕泊昔布仿制片剂的体外溶出行为;将帕泊昔布仿制片剂与参比片剂进行比较,评估其在4种溶出介质中溶出行为的相似性。结果表明:自制的帕泊昔布仿制片剂处方符合药典中对片剂质量的相关要求;通过HPLC法对4种溶出介质中的帕泊昔布进行检测,线性相关结果显示R2均大于0.99,测量结果客观准确,且回收率较好;4种溶出介质中帕泊昔布仿制片剂的体外溶出度与参比片剂相似,f2值均大于50。
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 determined through single-factor experiments and in vitro dissolution method. An in vitro dissolution test was performed 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 evaluate 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 correlation 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.

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备注/Memo

备注/Memo:
收稿日期: 2025-03-29
通信作者: 侯志勇(1972-),男,副主任药师,博士,主要从事创新药物的研究。E-mail:mpp5358@163.com。
基金项目: 国家重点研发计划项目(2016YFE0101700); 福建省高校产学合作重大项目(2019Y4007); 华侨大学研究生科研创新基金资助项目(18013071019)https://hdxb.hqu.edu.cn/
更新日期/Last Update: 2025-11-20