Effects of Unani Anxiolytics (Somina) on General Reproductive Performance and Teratology in Rats

Abstract

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 (2 nd group: 285 mg/kg/day) and the high dose of somina (3 rd 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 (γGT), 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.

Biochemical and Histopathological Effects on Liver Profile due to Acute and Subacute Oral Toxicity of Somina on Rats

“…Further, the cardiovascular activity of somina showed its hypotensive effect [3], positive inotropic and negative chronotropic effects [4]. Despite the scientific activities and significant effects of Somina, some of the single dose toxicological studies showed that somina is practically non-toxic [5], and did not produce any teratological effect [6]. However, these alternative herbal medicines have a risk of toxicity for human [7].…”

The Effect of Liman Leaves Extract on Fetal Rat Development

“…abnormalities which can be seen macroscopically. Fetal abnormalities were observed by looking at all external parts of the fetus from the head to the extremities using a surgical microscope [13][14][15][16].…”