甲硝唑在孕妇和乳妇中的临床药理研究

STUDY ON CLINICAL PHARMACOLOGY OF METRONIDAZOLE IN PREGNNT AND BREAST-FEEDING WOMEN

本文对甲硝唑在各期妊娠妇女中的组织穿透性在哺乳期妇女乳汁中的分泌进行了研究。结果表明，甲硝唑易穿过血胎盘屏障，进入各组织体液中。孕妇及乳妇接受单次静滴甲硝唑５００ｍｇ后，绒膜、蜕膜、胎儿、胎盘、脐带和羊水等组织、体液中的平均药物浓度可为同期母血浓度的２９～５３％，脐血为８９％。乳汁中药物浓度可与同期母血相当，给药后１ｈ为７．８５ｍｇ／Ｌ１２ｈ时尚可测得１．６７ｍｇ／Ｌ，乳汁药物平均半衰期为６．１７±２．１９ｈ．根据本研究结果提出在孕妇、乳妇中合理应用甲硝唑的建议。本文建立的甲硝唑组织、体液浓度高效液相色谱测定法简单、灵敏、可靠。不但适用于甲硝唑临床药理研究，还适用于甲硝吐临床血药浓度监测。

The tissue penetration of Metronidazole in pregnant wom-en of different gestation period and the excretion of the drug in breast milk in breast-feeding mothers were determined.The results showed that Metronidazole penetrated through blood-placenta barrier to various tissues and body fluids easily.Following a single intravenous infusion of 500mg of Metronidazole in pregnant and breast-feeding women,the mean drug concentrations in various tissues and body fluids such as chorion,endom-etrium,fetus,placenta,umbilical tissue and amniotic fluid were 29～53%f that in maternal blood at the same time,umbilical blood being 89%. The drug concentration in breast milk was almost equal to that in mate-rnal blood time. 1 hour after the drug admin istration,the mean milk dr-ug concentration was7.85 mg/L,.67mg/L 12 hours later,The elimina-ion half-life in breast milk was 6.17 ±2.19 h,Based upon the results of this study,the rational use of Metronidazole in pregnant and breast-fee-ding women was proposed.Tbe HPLC assay of the concentrations of Me-tronidazole in tissues and body fluids is simple、sensitive and reliable.It can be used not only in the study of clinical pharmacology but also in monitoring the clinical drug concentration of Metronidazole.