Judy William V
Integr Med (Encinitas). 2022 Feb;21(1):28-34.
The results for the absorption and bioavailability of different product formulations of Coenzyme Q10 (CoQ10) that are found in the literature are highly variable and confusing to CoQ10 researchers and consumers.
The study intended to measure and compare the single-dose absorption and steady-state bioavailability of three types of Crystal Free (CF) CoQ10 formulations-CF CoQ10, crystalline CQ10, and dry-powder CoQ10.
The researcher designed a randomized double-blind laboratory study for the three formulations that was conducted by the same laboratory and investigators and used the same protocol, the same analytical laboratory, and the same methods of analysis.
Participants were matched groups of normal males and females.
Single-dose absorption and steady-state bioavailability was determined for nine CoQ10 formulations: (1) three formulations of CF CoQ10 in lipid-based softgels, (2) three formulations of crystalline CoQ10 in lipid-based softgels, and (3) three formulations of dry-powder CoQ10 in two-piece, hard gelatin capsules. Plasma profiles were constructed and used to calculate the plasma level at Cmax and the percentage of the dose. From the steady-state bioavailability profiles, the plasma concentrations and the area under the curve (AUC) were determined. From that data, the relationship between the single-dose absorption and the steady-state bioavailability was derived using a linear regression analysis.
The single-dose absorption was significantly greater for the CF group compared to that for the crystalline and dry-powder groups ( ≤ .001). The absorption and bioavailability of the crystalline group was significantly greater than that for the dry-powder group ( ≤ .001). For the CF group, the Δ Cmax was 1.83 ± 0.58 ug/ml, the % absorption was 7.03 ± 2.03, the steady-state CoQ10 level was 3.28 ±0.92 ug/ml, and the AUC was 32.80 ± 10.05 ug/ml x days. For the crystalline group, the Δ Cmax was 1.40 ±0.24, the % absorption 3.08 ± 0.53, the steady-state plasma level was 2.50 ± 0.54 ug/ml, and the AUC was 7.55 ± 1.87 ug/ml x days. For the dry powder group, the Δ Cmax was 0.33 ± 0.05 ug/ml, the % absorption was 1.28 ± 0.96 %, the steady-state plasma CoQ10 level was 1.55 ± 0.43 ug/ml, and the AUC was 5.34 ± 1.10 ug/ml x days. The CF formulation's absorption and bioavailability were superior to that of the crystalline and the dry powder formulations. The relationship between the single-dose absorption and the steady-state bioavailability was described by the linear equation y = 1.26 x 1.60.
The CF formulation was superior in absorption and steady-state bioavailability compared to the crystalline and dry powder formulations. The linear relationship between the single-dose absorption and the steady-state bioavailability gives an estimate of the steady-state bioavailability in a 24-hour study compared to a longer and more expensive 30-day study.
文献中报道的不同辅酶Q10（CoQ10）产品制剂的吸收和生物利用度结果差异很大，这让CoQ10研究人员和消费者感到困惑。
本研究旨在测量和比较三种无定形（CF）CoQ10制剂——CF CoQ10、结晶型CoQ10和干粉状CoQ10的单剂量吸收和稳态生物利用度。
研究人员针对这三种制剂设计了一项随机双盲实验室研究，该研究由同一实验室和研究人员进行，采用相同的方案、相同的分析实验室和相同的分析方法。
参与者为正常男性和女性的匹配组。
测定了九种CoQ10制剂的单剂量吸收和稳态生物利用度：（1）三种脂质基软胶囊中的CF CoQ10制剂，（2）三种脂质基软胶囊中的结晶型CoQ10制剂，（3）三种两片式硬明胶胶囊中的干粉状CoQ10制剂。构建血浆浓度曲线，并用于计算Cmax时的血浆水平和剂量百分比。根据稳态生物利用度曲线，测定血浆浓度和曲线下面积（AUC）。根据这些数据，使用线性回归分析得出单剂量吸收与稳态生物利用度之间的关系。
CF组的单剂量吸收显著高于结晶型组和干粉状组（P≤.001）。结晶型组的吸收和生物利用度显著高于干粉状组（P≤.001）。对于CF组，ΔCmax为1.83±0.58μg/ml，吸收百分比为7.03±2.03，稳态CoQ10水平为3.28±0.92μg/ml，AUC为32.80±10.05μg/ml×天。对于结晶型组，ΔCmax为1.40±0.24，吸收百分比为3.08±0.53，稳态血浆水平为2.50±0.54μg/ml，AUC为7.55±1.87μg/ml×天。对于干粉状组，ΔCmax为0.33±0.05μg/ml，吸收百分比为1.28±0.96%，稳态血浆CoQ10水平为1.55±0.43μg/ml，AUC为5.34±1.10μg/ml×天。CF制剂的吸收和生物利用度优于结晶型和干粉状制剂。单剂量吸收与稳态生物利用度之间的关系由线性方程y = 1.26x + 1.60描述。
与结晶型和干粉状制剂相比，CF制剂在吸收和稳态生物利用度方面更具优势。单剂量吸收与稳态生物利用度之间的线性关系为在24小时研究中估计稳态生物利用度提供了依据，相比更长且更昂贵的30天研究。
