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目的:研制一种治疗阴道真菌感染的新型微乳泡沫制剂及质量检验方法。方法:根据药品审评中心的技术指导原则、《中华人民共和国药典》(2010年版二部)附录IL对喷雾剂的通则要求,对纳米银抗菌泡沫剂的处方组成、制备工艺进行实验研究。结果:纳米银抗菌泡沫剂组分中吐温80、甘油、十二烷基硫酸钠、硬脂酸的最佳用量分别为5%、10%、1.5%以及0.5%。制剂质量符合《中国药典》2010年版气雾剂通则项下的要求。结论:纳米银抗菌泡沫剂的处方合理,工艺可行,性能稳定。制备的3批工艺验证产品符合制订质量标准要求。
Objective: To develop a new type of microemulsion foam preparation for the treatment of vaginal fungal infection and its quality testing method. Methods: According to the technical guidelines of the Center for Drug Evaluation and the General Requirements of IL for Aerosol Spray in the Appendix of Pharmacopoeia of the People’s Republic of China (2010 Edition 2), the prescription composition and preparation process of nano-silver antibacterial foam were studied. Results: The optimal dosage of Tween 80, glycerin, sodium lauryl sulfate and stearic acid were 5%, 10%, 1.5% and 0.5% respectively. Preparation of quality in line with the “Chinese Pharmacopoeia” 2010 version of Aerosol General requirements. Conclusion: The prescription of nanometer silver antibacterial foam is reasonable, the technology is feasible and the performance is stable. Preparation of three batches of process validation products in line with the development of quality standards.