• 中国核心期刊(遴选)数据库收录期刊
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中国药物评价 ›› 2019, Vol. 36 ›› Issue (5): 358-362.

• 评价技术与方法 • 上一篇    下一篇

柳烯酸溶液喷雾剂质量标准改进的研究

徐威驰,陈冬华,严全鸿   

  1. 广东省药品检验所,广东省药品检验所,广东省药品检验所
  • 出版日期:2019-10-28 发布日期:2019-10-28

Improving Quality Standards of Salicylic Acid and Undecylenic Acid Liquid Spray

  1. Guangdong Institute for Drug Control,Guangdong Institute for Drug Control,
  • Online:2019-10-28 Published:2019-10-28

摘要: 目的:探讨柳烯酸溶液喷雾剂质量标准的改进方法。方法:采用HPLC法和GC法分别对水杨酸和十一烯酸组分进行含量测定;建立柳烯酸溶液喷雾剂中水杨酸(HPLC法)和十一烯酸(GC法)定量检测的方法。结果:含量测定方法准确可行;水杨酸和十一烯酸的浓度分别在0.02~0.25 mg·mL-1和0.08~0.58 mg·mL-1范围内有良好的线性关系(r=1.000 0,n=7和r=0.999 8,n=7),平均回收率分别为100.7%(RSD为0.8%,n=9)和100.6%(RSD为2.0%,n=9)。结论:完善后的质量标准具有专属性强、准确度高、重复性好的特点,可用于该制剂的质量控制。

关键词: 质量标准, 柳烯酸溶液喷雾剂, 水杨酸, 十一烯酸, 含量测定

Abstract: Objective: The improvement method of quality standards of Salicylic Acid and Undecylenic Acid Liquid Spray was discussed. Methods: The contents of Salicylic Acid and Undecylenic Acid were determined by HPLC and GC respectively. To establish a HPLC method for content determination of Salicylic Acid and a GC method for content determination of Undecylenic Acid in Salicylic Acid and Undecylenic Acid Liquid Spray. Results:The method for content determination is accurate and practicable. There were linear relationship within 0.02-0.25 mg·mL-1 for Salicylic Acid and 0.08-0.58 mg·mL-1 for Undecylenic Acid(r=1.000 0, n=7 and r=0.999 8, n=7).Their average recoveries were 100.7%(RSD was 0.8%,n=9),and 100.6% (RSD was 2.0%, n=9). Conclusion:The improved quality standards are specific,accurate and reproducible. They can be used for quality control of Salicylic Acid and Undecylenic Acid Liquid Spray.

Key words: Quality standards, Salicylic acid and undecylenic acid liquid spray, Salicylic acid, Undecylenic acid, Content determination