Benvenuti Claudio, Setnikar Ivo
Medical Department, Rottapharm | Madaus, Monza, Italy.
Arzneimittelforschung. 2011;61(11):605-9. doi: 10.1055/s-0031-1300562.
To verify the single dose bioavailability of two oral formulations of soy isoflavones, with and without lactobacilli, in menopausal women in antibiotic therapy.
Twelve menopause women (mean age 54.3 years, BMI 25.0 kg/m2) participated in a controlled cross-over study. Reference and test treatments were: R = tablets containing soy isoflavones 60 mg (genistin 30 mg + daidzin 30 mg) + calcium and vitamin D3; E = R + 500 million vital spores of Lactobacillus sporogenes (E is Estromineral, a food supplement containing soy isoflavones 60 mg, calcium 141 mg and vitamin D3 5 microg). The design included 2 periods of 5 days of amoxicillin + clavulanate treatment with a 2-week wash-out. After each period alternatively a single dose of each formulation was given in randomised sequence. Genistein and daidzein were determined in plasma by HPLC, sampled 10 times within 24 h after dosing.
Genistein pharmacokinetics parameters were higher after E than after R administration: peak plasma concentration (Cmax) +24.3%, area under the concentration curve (AUC0-24) +24.4% and mean residence time +11.0%. Daidzein Cmax and AUC showed a larger variability on R, evidenced by higher scatter from the mean on the formulation without lactobacilli.
A trend is shown for a greater absorption of genistein from a formulation containing lactobacilli.
验证两种含或不含乳酸菌的大豆异黄酮口服制剂在接受抗生素治疗的绝经后女性中的单剂量生物利用度。
12名绝经后女性（平均年龄54.3岁，体重指数25.0kg/m²）参与了一项对照交叉研究。参比和受试治疗分别为：R = 含60mg大豆异黄酮（染料木苷30mg + 黄豆苷30mg）+ 钙和维生素D3的片剂；E = R + 5亿个产孢乳酸杆菌活孢子（E为Estromineral，一种含有60mg大豆异黄酮、141mg钙和5μg维生素D3的食品补充剂）。研究设计包括两个为期5天的阿莫西林+克拉维酸治疗期，中间有2周的洗脱期。在每个治疗期后，交替随机给予每种制剂的单剂量。给药后24小时内采集10次血样，采用高效液相色谱法测定血浆中的染料木素和黄豆苷元。
与给予R制剂后相比，给予E制剂后染料木素的药代动力学参数更高：血浆峰浓度（Cmax）提高24.3%，浓度曲线下面积（AUC0-24）提高24.4%，平均驻留时间提高11.0%。黄豆苷元的Cmax和AUC在R制剂组的变异性更大，这在不含乳酸菌的制剂组中表现为均值的离散度更高。
含乳酸菌的制剂中染料木素的吸收呈现更高的趋势。
