Tatke Pratima A, Nidhiya I S R, Deshpande S G
Department of Pharmaceutical Chemistry, C. U. Shah College of Pharmacy, SNDT Women's University, Santacruz (West), Mumbai, India.
Toxicol Int. 2012 May;19(2):106-11. doi: 10.4103/0971-6580.97196.
Gynocare capsules, is a polyherbal formulation, are used as uterine tonic and for treating gynaecological ailments like infertility, leucorrhea, and menstrual disorders. The formulation contains ingredients of herbal origin, such as, extracts of Ashoka, Vasaka, Durva, Chandan, Musk, and so on. It was evaluated for its safety at the therapeutic dose level by a repeated dose oral toxicity study in albino Wistar rats. The herbal formulation was administered orally at a therapeutic dose of 100 mg/kg/day, for 90 days. All animals were monitored daily for their health status and signs of abnormalities. The body weight, water consumption, and food intake were measured once weekly. At the end of the experimental period, various hematological and biochemical parameters were estimated and histopathologies of selected organs were conducted. The study resulted from the long-term oral administration of Gynocare capsules (100 mg/kg), did not cause any relevant signs of toxicity nor significant changes in the physical, hematological and biochemical parameters. However, statistically significant differences were seen in the relative organ weights of adrenal gland, ovary, and serum creatinine levels. The reduction in ovary weight revealed the possibility of the drug targeting the ovary. Moreover, no pathological features were identified in the treated group as monitored by the histopathological analysis of the internal organs. The study established that Gynocare capsules at the dose given (100 mg/kg) did not induce any remarkable or significant toxic effects, indicating that it was safe in rats following oral administration for 90 consecutive days.
妇科保健胶囊是一种多草药配方制剂，用作子宫滋补剂，用于治疗诸如不孕、白带异常和月经紊乱等妇科疾病。该配方含有草药成分，如无忧花提取物、瓦萨卡、杜尔瓦、檀香、麝香等。通过对白化Wistar大鼠进行重复剂量口服毒性研究，评估了其在治疗剂量水平下的安全性。将该草药制剂以100毫克/千克/天的治疗剂量口服给药，持续90天。每天监测所有动物的健康状况和异常体征。每周测量一次体重、饮水量和食物摄入量。在实验期结束时，评估了各种血液学和生化参数，并对选定器官进行了组织病理学检查。长期口服妇科保健胶囊（100毫克/千克）的研究结果表明，未引起任何相关的毒性体征，也未导致身体、血液学和生化参数发生显著变化。然而，肾上腺、卵巢的相对器官重量和血清肌酐水平出现了统计学上的显著差异。卵巢重量的减轻表明该药物可能作用于卵巢。此外，通过对内部器官的组织病理学分析监测，治疗组未发现病理特征。该研究证实，给予剂量为100毫克/千克的妇科保健胶囊不会诱导任何显著或明显的毒性作用，表明连续90天口服给药对大鼠是安全的。
