Absence of Teratogenic Effect of Liv.52 in Albino Rats

The teratogenic potential of Liv.52, a commonly used liver protective and rejuvenating agent of herbal “Ayurvedic” origin, was studied. The crude powder suspended in normal saline was administered orally to female pregnant rats in a dose of 100 mg/100 g of body weight during the entire period of gestation. This dose of Liv.52 had no adverse effect on body weight, growth and size of the offspring as compared to controls (non-drug treated). It did not induced any limb deformity in any of the offspring of the treated animals. There was no significant difference in fertility index (FI), lactation index (LI), gestation index (GI), live birth index (LBI) and Teratogenicity index (TI) in the Liv.52-treated animals as compared to the normal control group of animals. Thus, Liv.52 was found to be devoid of any teratogenicity in rats. INTRODUCTION Liv.52, a compound herbal remedy, is one of the most extensively used preparations for a variety of liver disorders in this country. A number of experimental and clinical studies have provided ample proof of its liver protective effect in these disorders. As the remedy is used for prolonged periods, particularly in cases of infective hepatitis both in males and females, the possibility of any teratogenicity in spite of its innocuous nature cannot be excluded. Therefore, the present study was carried out to evaluate the presence of such activity, if any. EXPERIMENTAL PROCEDURES Liv.52 powder supplied by The Himalaya Drug Company was suspended in normal saline and given orally to pregnant female rats in this study. The study was carried out by the method of Persaud and Ellington (1968), Shott et al., (1971) and Singh et al., (1981) in healthy female, nonpregnant albino rats weighing between 180-200 g. They were maintained on a special semifluid diet consisting of whole-wheat flour (10.0 g), milk powder (1.0 g), glucose (0.1 g) and water (100 ml). This diet was allowed ad libitum. The animals were divided in two groups consisting of 12 animals each and co-habited with healthy adult male rats of proven fertility. Vaginal smears were examined daily under the microscope and the day they showed thick clumps of spermatozoa was designated as day ‘0’ of pregnancy. Animals of the first group served as controls and were treated with normal saline. Animals of the second group were treated with Liv.52 powder suspended in normal saline which was administered orally with the help of a feeding cannula at a dose of 100 mg/100 g body weight daily during the entire period of gestation, beginning from day ‘0’ of pregnancy. The pregnant animals were watched daily for abortions. The animals were allowed to continue to term till delivery for any evidence of teratogenicity and malformations. Further, the offspring were sacrificed and their internal organs such as the heart, lungs, spleen, gastrointestinal viscera and gonads were examined grossly and microscopically for any evidence of teratogenicity. The reproductive indices, viz. fertility index (FI), gestation index (GI), live birth index (LBI), lactation index (LI) and teratogenicity index (TI) were calculated according to Shott et al., (1971). RESULTS The results are summarized in Table 1. Table 1: Reproductive indices for rats chronically treated with Liv.52 Number of rats Total No. of pups born Indices % Treatment Dose, route & administration M at ed Pr eg na nt