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两种环孢素口服溶液制剂在猫体内的药代动力学和生物等效性

Pharmacokinetics and bioequivalence of two cyclosporine oral solution formulations in cats.

作者信息

Yang Yuxin, Kong Jingyuan, Liu Yu, Wu Qinyao, Cao Yuying, Qiu Jicheng, Zhang Lu, Gong Xiaohui, Zhao Fuhua, Cao Xingyuan, Wang Jianzhong

机构信息

Department of Veterinary Pharmacology and Toxicology, College of Veterinary Medicine, China Agricultural University, Beijing, China.

China Institute of Veterinary Drug Control, Beijing, China.

出版信息

Front Vet Sci. 2022 Aug 10;9:940472. doi: 10.3389/fvets.2022.940472. eCollection 2022.

Abstract

The pharmacokinetic profiles and bioequivalence of two cyclosporine oral solutions were investigated in cats. Twenty-four cats were randomly allocated to two equally sized treatment groups in a randomized four-cycle, and dual-sequence cross-over design. Test and reference articles were orally administered in a single dose of 7 mg/kg Bodyweight. Serial blood samples were collected, and blood cyclosporine concentration was determined by ultra-performance liquid chromatography-mass spectrometry (UPLC-MS/MS). No significant differences were present in the major pharmacokinetic parameters (C, AUC,) between the two formulations. The blood profiles of cyclosporine following the administration of both formulations were similar. The findings of the study suggested that the two articles were bioequivalent for cyclosporine oral solution.

摘要

在猫身上研究了两种环孢素口服溶液的药代动力学特征和生物等效性。24只猫被随机分配到两个大小相等的治疗组,采用随机四周期、双序列交叉设计。试验制剂和参比制剂均以7mg/kg体重的单剂量口服给药。采集系列血样,采用超高效液相色谱-质谱联用仪(UPLC-MS/MS)测定血中环孢素浓度。两种制剂的主要药代动力学参数(Cmax、AUC)无显著差异。两种制剂给药后的环孢素血药浓度曲线相似。该研究结果表明,两种制剂的环孢素口服溶液具有生物等效性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b314/9399922/36a014503c38/fvets-09-940472-g0001.jpg

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