Adomnicăi M, Dobrescu G, Ionescu G D, Costea I, Mungiu O C, Teslariu E, Filip C, Iosep R
Laboratorul central de testare a medicamentiului, Institutul de Medicină şi Farmacie, Iaşi.
Rev Med Chir Soc Med Nat Iasi. 1990 Apr-Jun;94(2):369-73.
The teratogen action of Boicil tablets was studied in two animal species, rats and mice, the prefertilization and implantation stages being the main interest. Three generations of animals were followed up. The active powder suspended in distilled water (0.1 ml/10 g for mice and 1 ml/100 g for rats) was administered per os in a single dose, prepared on spot and in two doses, 2 mg/kg body weight and 20 mg kg body weight, respectively. The administered doses were equivalent to the daily maximum therapeutic dose prescribed in humans (110 mg active principle). The first gestational day was determined differently in the two species. For estimating the effect on prefertilization, Boicil tablets was administered for 5 days before making and for its effects on the number of implantations during the first 3 gestational days. The two parameters under investigation were within normal limits and all newborn animals followed up for three generations did not present pathological microscopic and gross alterations or somatic malformations. It was concluded that Boicil tablets is not teratogenic.
在大鼠和小鼠这两种动物身上研究了波西尔片的致畸作用，主要关注受精前和着床阶段。对三代动物进行了跟踪。将活性粉末悬浮于蒸馏水中（小鼠为0.1毫升/10克，大鼠为1毫升/100克），按单剂量经口给药，现场配制，分两个剂量，分别为2毫克/千克体重和20毫克/千克体重。给药剂量相当于人类规定的每日最大治疗剂量（110毫克活性成分）。在这两个物种中确定妊娠首日的方法不同。为评估对受精前的影响，在交配前5天给予波西尔片，评估其对妊娠前3天着床数量的影响。所研究的两个参数均在正常范围内，对三代新生动物进行跟踪，未发现病理微观和大体改变或躯体畸形。得出结论：波西尔片无致畸性。
