EFFECTS OF UNANI ANXIOLYTICS (SOMINA) ON GENERAL REPRODUCTIVE PERFORMANCE AND TERATOLOGY IN RATS
Keywords:Somina, Teratogenic activity, Two-generation reproductive toxicity, F1 breed, F2 breed, Uterine growth index, Fertility index
Objective: Somina (herbal medicine) is used in Pakistan as Unani anxiolytics. It is composed of five medicinal plants. The current work was designed to evaluate the general reproductive and teratogenic effects of somina in two consecutive generations of rats according to the OECD guideline.
Methods: Fertility study (a two-phase study) was done in Sprague-Dawley rats. 1st part: three groups' female rats (10 rats each group) received different doses orally. First group: The control group (saline), a single oral human dose of somina (2nd group: 285 mg/kg/day) and the high dose of somina (3rd group: 1g/kg/day) during the whole period of gestation till the delivery of pups named as F1 Breed. For the second part of study ten females were selected from each F1 breed (control, somina 285 mg/kg/d, somina 1g/kg/day) and administered the same treatment from day first of mating than the entire period of gestation until F1 breed delivered pups (F2 breed). For F1 and F2 breed the fertility index and litter size were determined. Some of the female rats (F1 and F2) were anesthetized and autopsied. The blood sample was subjected to biochemical analysis and serum liver function test: bilirubin, gamma-glutamyl transferase (Î³GT), alanine aminotransferase (ALT: SGPT), aspartate aminotransferase (AST: SGOT) and alkaline phosphatase (ALP) were measured spectrophotometrically. The uterine growth index, fertility index, and litter size were also measured to evaluate the teratogenic effects of somina treated rats.
Results: The data showed that any significant different (P>0.05) was not found during the maternal examination (uterine growth index, fertility index) and reproductive parameters (litter size, the quantity of fetus, aborted or absorbed fetus) in somina treated rats as compare to control rats (P>0.05). Control and treated Pups did not show any significant (P>0.05) malformation and any congenital defects. Non-significant (P>0.05) changes were observed in liver function test. It was found normal in all groups. Macroscopic autopsy examination also did not reveal any significant (P>0.05) pathological findings in the liver, kidneys, and uterus.
Conclusion: The oral administration of somina during the gestational period of pregnant female rats was not teratogenic/fetotoxic. Any adverse or deleterious effects were not observed at the dose of 285 mg/kg (human dose) or 1g/kg (3times greater than the human dose) during pregnancy, and it is safe in rats.
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