姜黄素新制剂的比较药代动力学和提高健康成人生物利用度的证据。

IF 0.9 4区 医学 Q4 PHARMACOLOGY & PHARMACY International journal of clinical pharmacology and therapeutics Pub Date : 2022-12-01 DOI:10.5414/CP204257
Akiko Hirose, Yoshitaka Kuwabara, Yoko Kanai, Chieko Kato, Yuji Makino, Fukumoto Yoshi, Kazumoto Sasaki
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引用次数: 1

摘要

目的:Theracurmin含有姜黄素成分CR-033P,具有很高的生物利用度。为了比较CR-033P、CR-043P中使用变性淀粉替代分散剂胶的CR-043P和含有新开发的无定形姜黄素的TS-P1三种组合物的药代动力学,采用随机双盲交叉研究(3路、3期)。材料与方法:健康成人接受单剂量姜黄素胶囊(TS-P1 45 mg, CR-033P 90 mg, CR-043P 90 mg)。给药后24 h采血,采用高效液相色谱-串联质谱法测定血浆总姜黄素浓度。结果:TS-P1和CR-043P在0-24h浓度时间曲线下的AUC面积略低于CR-033P,而TS-P1与CR-043P表现出生物等效性。此外,TS-P1在AUC0-12h方面与CR-033P表现出生物等效性,而CR-043P的AUC0-12h有低于CR-033P的趋势。TS-P1的AUC0-12h高于CR-043P。差异有统计学意义(p max。TS-P1的Cmax倾向于高于CR-033P, CR-043P的Cmax倾向于略低于CR-033P, TS-P1的Cmax倾向于高于CR-043P。结论:新开发的TS-P1组合物与CR-033P组合物相比,除了更高的血浆浓度外,似乎具有类似的姜黄素全身暴露。此外,CR-043P和CR-033P之间只有少数显著差异。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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Comparative pharmacokinetics of new curcumin preparations and evidence for increased bioavailability in healthy adult participants.

Objective: Theracurmin, which contains the curcumin composition, CR-033P, has been demonstrated to be highly bioavailable. To compare the pharmacokinetics of the three compositions, CR-033P, CR-043P using modified starch as an alternative to the dispersant gum ghatti used in the CR-033P, and TS-P1 containing the newly developed amorphous curcumin, a randomized double-blind crossover study (3-way, 3-period) was conducted.

Materials and methods: A single dose of the curcumin capsules (TS-P1 45 mg, CR-033P 90 mg, and CR-043P 90 mg) was administered to healthy adult participants. Blood sampling was performed 24 hours after capsule administration, and the plasma concentration of total curcumin was determined using high-performance liquid chromatography coupled with tandem mass spectrometry.

Results: TS-P1 and CR-043P tended to have a slightly lower area under the concentration time curve (AUC) 0-24h than CR-033P, while TS-P1 displayed bioequivalence to CR-043P. Further, TS-P1 displayed bioequivalence to CR-033P in terms of AUC0-12h, while that of CR-043P tended to be lower than that of CR-033P. TS-P1 had a higher AUC0-12h than CR-043P. A statistically significant difference (p < 0.001) was found between the preparations in terms of Cmax. TS-P1 tended to have a higher Cmax than CR-033P, CR-043P tended to have a slightly lower Cmax than CR-033P, and TS-P1 tended to have a higher Cmax than CR-043P.

Conclusion: The newly developed TS-P1 composition seemed to display similar curcumin systemic exposure except for a higher plasma concentration than the CR-033P composition. Further, only a few significant differences were found between CR-043P and CR-033P.

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来源期刊
CiteScore
1.70
自引率
12.50%
发文量
116
审稿时长
4-8 weeks
期刊介绍: The International Journal of Clinical Pharmacology and Therapeutics appears monthly and publishes manuscripts containing original material with emphasis on the following topics: Clinical trials, Pharmacoepidemiology - Pharmacovigilance, Pharmacodynamics, Drug disposition and Pharmacokinetics, Quality assurance, Pharmacogenetics, Biotechnological drugs such as cytokines and recombinant antibiotics. Case reports on adverse reactions are also of interest.
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