| 本文已被：浏览 1136次 下载 966次 |
码上扫一扫！ |
| 酸碱滴定法测定复方乳酸依沙吖啶软膏中硼酸的含量 |
| 张建1,王晓玲1,魏京海1,刘宗洋1,李云晴2,王海伦1,王文莉1,安芳1 |
|
|
| (1. 首都医科大学附属北京儿童医院,北京 100045;2. 首都医科大学中医药临床医学院,北京 100069) |
|
| 摘要: |
| 目的:建立复方乳酸依沙吖啶软膏中硼酸的含量测定方法。 方法:采用酸碱滴定法对同一批次复方乳酸依沙吖啶软膏供试品进行硼酸含量测定,对其专属性、线性范围、精密度、准确度实验结果进行数据分析,以判断方法的适用性。 结果:本实验方法专属性良好,硼酸在 5. 05~51. 60 mg 范围内线性关系良好,线性方程 Y = 0. 160 498X+0. 051 24(r = 0. 999 98);硼酸检出限为 0. 2 mg,定量限为 0. 6 mg;重复性实验相对标准差(RSD)为 0. 37%(n = 6),精密度实验 RSD 为 0. 58%(n = 12);硼酸平均加样回收率为 99. 1% ~100%(RSD<1. 0%)。 结论:该方法简单、快速,测定结果均符合《中华人民共和国药典》2020 年版四部通则9101 要求,适用于复方乳酸依沙吖啶软膏中硼酸的含量测定。 |
| 关键词: 复方乳酸依沙吖啶软膏 硼酸 含量测定 酸碱滴定法 |
| DOI：10. 13407/ j. cnki. jpp. 1672-108X. 2023. 09. 002 |
|
| 基金项目:首都医科大学附属北京儿童医院研究平台专项,编号 YPT202101 |
|
| Content Determination of Boric Acid in Compound Ethacridine Lactate Ointment by Acid-Base Titration Method |
| Zhang Jian1, Wang Xiaoling1, Wei Jinghai1, Liu Zongyang1, Li Yunqing2, Wang Hailun1, Wang Wenli1, AnFang1 |
| (1. Beijing Children’s Hospital, Capital Medical University, Beijing 100045, China; 2. School of Traditional Chinese Medicine, Capital Medical University, Beijing 100069, China) |
| Abstract: |
| To establish a method for determining the boric acid content in compound ethacridine lactate ointment. Methods: Boric acid content of the same batch of compound ethacridine lactate ointment was determined by the acid-base titration method, experimental results of specificity, linear range, precision and accuracy were analyzed to evaluate its applicability. Results: The method demonstrated good specificity. Boric acid showed good linearity in the range from 5. 05 to 51. 60 mg, with the linear equation Y = 0. 160,498X+0. 051,24 (r = 0. 999,98). The detection limit of boric acid was 0. 2 mg, and the limit of quantification was 0. 6 mg, the relative standard deviation (RSD) of repeatability experiment was 0. 37% (n = 6), and the RSD of precision experiment was 0. 58% (n = 12). The average recovery rate of boric acid ranged from 99. 1% to 100% (RSD<1. 0%). Conclusion: The experimental method is simple and fast, and all the determination results are in accordance with the requirements of the part Ⅳ general rule 9101, Pharmacopoeia of the People’ s Republic of China 2020. Therefore, it is suitable for the determination of boric acid in compounded ethacridine lactate ointment. |
| Key words: compound ethacridine lactate ointment boric acid content determination acid-base tritracion |
