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目的:制备甲磺酸雷沙吉兰(rasagiline mesylate,RM)鼻用凝胶剂并对其进行质量评价。方法:以外观、涂展性以及释放度为评价指标,采用正交试验优选RM鼻用凝胶剂的处方及制备工艺;对所制备RM鼻用凝胶剂的外观、pH值、药物与防腐剂的含量、释放度以及有关物质等质量指标进行研究。结果:RM鼻用凝胶剂的最佳处方组成为:0.5%的RM,0.4%的卡波姆940,0.05%的尼泊金乙酯,20%的丙二醇,三乙醇胺及水适量;该制剂的理想pH值约为6.5;制剂的外观、pH值、RM与防腐剂的含量以及有关物质等质量指标均符合2010年版《中华人民共和国药典》有关要求。结论:RM鼻用凝胶剂组成合理,制备工艺简单,质量稳定可控,是一种有开发前景的经鼻给药新制剂。
Objective: To prepare rasagiline mesylate (RM) nasal gel and evaluate its quality. Methods: According to the appearance, spreadability and release degree as evaluation indexes, orthogonal test was used to optimize the preparation and preparation of RM nasal gel. The appearance, pH value, drug and antiseptic Agent content, release and quality indicators such as related substances to study. Results: The optimum formulation of RM nasal gel was 0.5% RM, 0.4% carbomer 940, 0.05% paraben, 20% propylene glycol, triethanolamine and water. The formulation Of the ideal pH value of about 6.5; formulation appearance, pH, RM and preservative content and related substances and other quality indicators are in line with the 2010 edition of “People’s Republic of China Pharmacopoeia” the relevant requirements. Conclusion: RM nasal gel composition is reasonable, the preparation process is simple, stable and controllable quality, is a promising nasal preparation of new agents.