Consistency Evaluation of Dissolution Curves of Cefixime Capsules
10.3870/j.issn.1004-0781.2024.03.017
- VernacularTitle:头孢克肟胶囊溶出曲线一致性评价研究
- Author:
Weiwen YE
1
;
Lin GAO
;
Guowei CAI
;
Yecai LAI
;
Fei QIN
Author Information
1. 广州白云山医药集团股份有限公司白云山制药总厂/广东省化学药原料与制剂关键技术研究重点实验室,广州 510515
- Keywords:
Cefixime capsules;
Dissolution curves;
Consistency evaluation;
High performance liquid chromatography
- From:
Herald of Medicine
2024;43(3):424-430
- CountryChina
- Language:Chinese
-
Abstract:
Objective To develop a method for rapid determination of the dissolution of cefixime capsules,to explore the consistency of the dissolution curves of the generic and reference preparations in different media,and to assess the reliability of the in vitro dissolution evaluation method according to the results of bioequivalence studies.Methods The dissolution test was performed by the paddle method at 50 r·min-1,using pH1.2 hydrochloric acid solution,pH6.8 phosphate buffer solution,pH7.5 phosphate buffer solution,and water as the dissolution media.And a high-performance liquid chromatography(HPLC)method with a core-shell column was established to determine the dissolution curves of the generic and reference preparations respectively.The bioequivalence of the generic and reference preparations was evaluated through the bioequivalence(BE)test.Results The similarity factors(f2)of the three batches of the generic and reference preparations in the four media were greater than 60.The fasting and postprandial pharmacokinetic parameters(Cmax,AUC0-t,AUC0-∞)of the generic and reference preparations in hu-mans were all in line with the bioequivalence standard.Conclusion The in vitro dissolution behavior of the generic and refer-ence preparations was consistent,and the two preparations were bioequivalent.The method is simple and quick,and it can be em-ployed to measure the dissolution of cefixime capsules,which can provide references for the consistency evaluation of cefixime capsules.
