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目的:研制聚维酮碘泡腾颗粒。方法:以溶液pH、颗粒性状及溶化性为指标筛选处方及工艺,并制定质量标准。结果:以酒石酸、碳酸氢钠为泡腾剂,聚维酮醇液作黏合剂制得的聚维酮碘泡腾颗粒符合临床用药要求。结论:本制剂工艺简便,质量可控。
Objective: To develop Povidone Iodine effervescent granules. Methods: The solution pH, particle properties and solubility as an indicator screening prescription and technology, and to develop quality standards. Results: Povidone iodine effervescent granules with tartaric acid and sodium bicarbonate as effervescent agents and Povidone alcohol as binders met clinical requirements. Conclusion: The preparation process is simple, quality controllable.