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首页> 外文期刊>The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology >Systemic absorption of clindamycin after intravaginal administration of clindamycin phosphate ovule or cream.
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Systemic absorption of clindamycin after intravaginal administration of clindamycin phosphate ovule or cream.

机译：阴道注射克林霉素磷酸胚珠或乳膏后，克林霉素的全身吸收。

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摘要

The absolute bioavailability of clindamycin phosphate vaginal ovule with comparison to a reference treatment of clindamycin phosphate sterile solution, as well as the relative bioavailability of the ovule compared to clindamycin phosphate vaginal cream, was evaluated in 12 healthy adult female volunteers. Subjects were randomly assigned to receive either the ovule or cream formulation intravaginally for 3 consecutive days during the two-way crossover portion of the study. During a third treatment period, all subjects received 100 mg of clindamycin as a 4-minute intravenous infusion of clindamycin phosphate sterile solution (10 mg/mL). Clindamycin concentrations in serum were assayed by a high-performance liquid chromatography method with detection by mass spectrometry. Pharmacokinetic analyses of the serum data indicated low systemic absorption of clindamycin from the vaginal cream (about 4%), consistent with results of previous bioavailability studies. Following intravaginal administration of the clindamycin phosphate ovule, systemic absorption averaged 30%, which was approximately sevenfold greater than after dosing with the vaginal cream. The higher drug absorption for the ovule may be related to differences in formulation effects on the vaginal membrane. Nevertheless, systemic exposure to clindamycin from the ovule is still considerably lower than from a therapeutic oral dose.
机译：在12位健康的成年女性志愿者中，评估了与克林霉素磷酸酯无菌溶液的参考治疗相比，克林霉素磷酸酯阴道胚珠的绝对生物利用度，以及与克林霉素磷酸酯阴道霜相比胚珠的相对生物利用度。在研究的双向转换部分中，受试者被随机分配连续3天接受阴道内的胚珠或乳膏制剂。在第三次治疗期间，所有受试者均接受100 mg克林霉素的4分钟静脉注射克林霉素磷酸盐无菌溶液（10 mg / mL）。通过高效液相色谱法和质谱检测法测定血清中的克林霉素浓度。血清数据的药代动力学分析表明，克林霉素从阴道乳膏中的全身吸收较低（约4％），与先前的生物利用度研究结果一致。阴道内施用克林霉素磷酸胚珠后，全身吸收平均为30％，约为阴道用药后的7倍。胚珠对药物的较高吸收可能与制剂对阴道膜的作用不同有关。然而，从胚珠到克林霉素的全身暴露仍然比口服治疗剂量低得多。

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