Garg S, Taluja V, Upadhyay S N, Talwar G P
National Institute of Immunology, New Delhi, India.
Contraception. 1993 Dec;48(6):591-6. doi: 10.1016/0010-7824(93)90120-v.
Praneem polyherbal cream, a spermicidal formulation, has been developed at the National Institute of Immunology, which makes use of Praneem, a purified extract from the dried seeds of an ancient Indian plant Azadirachta indica (Neem), extract from the pericarp of fruits of Sapindus species and quinine hydrochloride. These ingredients have a synergistic spermicidal activity and an optimised formula was derived. The components were made into a water-soluble cream base prepared by using pharmaceutically acceptable base and stabilised by addition of IP grade antioxidant and preservatives. The cream is devoid of irritation and sensitization potential, as seen with standard Draize test on normal and abraded skin of rabbits and by 21-day cumulative skin sensitivity in human volunteers. The formulation was found to be safe under subacute toxicity studies in monkeys. The formulation has shown high contraceptive efficacy in rabbits and in monkeys after intravaginal application. The shelf-life of the cream at room temperature is estimated to be 18 months by accelerated stability studies.
普拉内姆多草药乳膏是一种杀精制剂，由国家免疫研究所研发，它利用了普拉内姆（一种从古老的印度植物印楝（楝树）干燥种子中提取的纯化提取物）、无患子属果实果皮提取物和盐酸奎宁。这些成分具有协同杀精活性，并由此得出了优化配方。这些成分被制成一种水溶性乳膏基质，该基质采用药学上可接受的基质制备，并通过添加IP级抗氧化剂和防腐剂来稳定。如在对正常和擦伤皮肤的兔子进行的标准Draize试验以及在人类志愿者中进行的21天累积皮肤敏感性试验所示，该乳膏没有刺激和致敏的可能性。在猴子的亚急性毒性研究中发现该制剂是安全的。该制剂经阴道给药后在兔子和猴子身上均显示出高避孕效果。通过加速稳定性研究估计，该乳膏在室温下的保质期为18个月。
