[The evaluation of the teratogenesis and embryotoxicity of the pharmaceutical product Boicil tablets. I. The effect of the pharmaceutical product Boicil tablets on fertilization and implantation in rats and mice].
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.
Adomnicăi
M
M
Laboratorul central de testare a medicamentiului, Institutul de Medicină şi Farmacie, Iaşi.
Dobrescu
G
G
Ionescu
G D
GD
Costea
I
I
Mungiu
O C
OC
Teslariu
E
E
Filip
C
C
Iosep
R
R
D000014:Abnormalities, Drug-Induced / Q000209:etiology*; D000818:Animals; D000893:Anti-Inflammatory Agents / Q000633:toxicity*; D004305:Dose-Response Relationship, Drug; D010064:Embryo Implantation / Q000187:drug effects*; D004622:Embryo, Mammalian / Q000187:drug effects*; D005260:Female; D005306:Fertilization / Q000187:drug effects*; D006027:Glycosides / Q000633:toxicity*; D051379:Mice; D010936:Plant Extracts / Q000633:toxicity; D010946:Plants, Medicinal; D010947:Plants, Toxic; D051381:Rats; D011919:Rats, Inbred Strains; D012503:Saponins / Q000633:toxicity*; D013256:Steroids; D013607:Tablets; D013997:Time Factors; D014703:Veratrum
D000893:Anti-Inflammatory Agents; C050166:Boicil; D006027:Glycosides; D010936:Plant Extracts; D012503:Saponins; D013256:Steroids; D013607:Tablets
Evaluarea teratogenezei şi embriotoxicităţii la produsul farmaceutic Boicil-comprimate. Nota I: Efectul produsului farmaceutic Boicil-comprimate asupra fertilizării şi implantării la şobolani şi şoareci.