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
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。

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

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

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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