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已发表论文
脂质体米托蒽醌血浆总浓度和游离浓度的测定及其在成人复发或难治性外周 T 细胞淋巴瘤患者中的临床应用
Authors Xu Y , Zhang Q, Qie H, Gao X , Gao J , Feng Z , Wang M
Received 22 May 2025
Accepted for publication 3 November 2025
Published 14 November 2025 Volume 2025:19 Pages 10093—10108
DOI https://doi.org/10.2147/DDDT.S542030
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Professor Tamer Ibrahim
Yuxiang Xu, Qi Zhang, Hongxin Qie, Xiaonan Gao, Jinglin Gao, Zhangying Feng, Mingxia Wang
Department of Clinical Pharmacology, The Fourth Hospital of Hebei Medical University, Shijiazhuang, 050011, People’s Republic of China
Correspondence: Mingxia Wang, Department of Clinical Pharmacology, The Fourth Hospital of Hebei Medical University, 12 Jiankang Road, Shijiazhuang, 050011, People’s Republic of China, Tel +86-311-86296233, Email 46700792@hebmu.edu.cn
Purpose: Currently reported methods for determining plasma concentration of mitoxantrone primarily measure total drug concentration. However, methodologies for quantifying liposomal mitoxantrone, particularly the free drug fraction, are lacking. Since the free drug represents the pharmacologically active moiety responsible for therapeutic effects, this study aimed to establish a detection method for total and free concentration of liposomal mitoxantrone in human plasma, while also exploring the temporal changes in drug concentration throughout the dosing cycle for liposomal mitoxantrone.
Patients and Methods: For total mitoxantrone, the mobile phase consisted of 10 mmol/L KH2PO4 and methanol, UV detection was performed at a wavelength of 610 nm and protein precipitation was utilized as a pretreatment method. For free mitoxantrone, a gradient elution program in 6.5 min using the mobile phase that made up by 0.2% formic acid and 10mM ammonium acetate water (A) and acetonitrile (B) after a simple pretreatment by solid phase extraction. Sixty-eight total mitoxantrone samples from 35 patients and 61 free mitoxantrone samples from 31 patients with relapsed or refractory peripheral T-cell lymphoma who received intravenous infusions of liposomal mitoxantrone-based chemotherapy regimen were determined.
Results: The linear calibration range of total and free mitoxantrone were 0.1– 5 μg/mL and 5– 500 ng/mL (r2> 0.99), respectively. Both intra- and inter-batch precision were less than 10.15%, and the accuracy ranged from 91.07% to 116.82%. The average total concentration in T-cell lymphoma patients after 12 hours of administration was 10.47 μg/mL, while the average free concentration was 272.22 ng/mL.
Conclusion: In this study, we established UPLC and UPLC-MS/MS methods for determining the total and free concentrations of liposomal mitoxantrone which were highly efficient, accurate, specific and suitable for clinical application and investigating the pharmacokinetics. Correlation analysis revealed that gender might be an important factor influencing the concentration of liposomal mitoxantrone in patients with relapsed or refractory peripheral T-cell lymphoma.
Keywords: liposomal mitoxantrone, UPLC, total concentration, free concentration, UPLC-MS/MS, relapsed or refractory peripheral T-cell lymphoma
Department of Clinical Pharmacology, The Fourth Hospital of Hebei Medical University, Shijiazhuang, 050011, People’s Republic of China
Correspondence: Mingxia Wang, Department of Clinical Pharmacology, The Fourth Hospital of Hebei Medical University, 12 Jiankang Road, Shijiazhuang, 050011, People’s Republic of China, Tel +86-311-86296233, Email 46700792@hebmu.edu.cn
Purpose: Currently reported methods for determining plasma concentration of mitoxantrone primarily measure total drug concentration. However, methodologies for quantifying liposomal mitoxantrone, particularly the free drug fraction, are lacking. Since the free drug represents the pharmacologically active moiety responsible for therapeutic effects, this study aimed to establish a detection method for total and free concentration of liposomal mitoxantrone in human plasma, while also exploring the temporal changes in drug concentration throughout the dosing cycle for liposomal mitoxantrone.
Patients and Methods: For total mitoxantrone, the mobile phase consisted of 10 mmol/L KH2PO4 and methanol, UV detection was performed at a wavelength of 610 nm and protein precipitation was utilized as a pretreatment method. For free mitoxantrone, a gradient elution program in 6.5 min using the mobile phase that made up by 0.2% formic acid and 10mM ammonium acetate water (A) and acetonitrile (B) after a simple pretreatment by solid phase extraction. Sixty-eight total mitoxantrone samples from 35 patients and 61 free mitoxantrone samples from 31 patients with relapsed or refractory peripheral T-cell lymphoma who received intravenous infusions of liposomal mitoxantrone-based chemotherapy regimen were determined.
Results: The linear calibration range of total and free mitoxantrone were 0.1– 5 μg/mL and 5– 500 ng/mL (r2> 0.99), respectively. Both intra- and inter-batch precision were less than 10.15%, and the accuracy ranged from 91.07% to 116.82%. The average total concentration in T-cell lymphoma patients after 12 hours of administration was 10.47 μg/mL, while the average free concentration was 272.22 ng/mL.
Conclusion: In this study, we established UPLC and UPLC-MS/MS methods for determining the total and free concentrations of liposomal mitoxantrone which were highly efficient, accurate, specific and suitable for clinical application and investigating the pharmacokinetics. Correlation analysis revealed that gender might be an important factor influencing the concentration of liposomal mitoxantrone in patients with relapsed or refractory peripheral T-cell lymphoma.
Keywords: liposomal mitoxantrone, UPLC, total concentration, free concentration, UPLC-MS/MS, relapsed or refractory peripheral T-cell lymphoma