| 摘要: |
| 目的：建立复方乳酸依沙吖啶软膏中氧化锌的含量测定方法。方法：采用络合滴定法对同一批次复方乳酸依沙吖啶软膏供试品进行氧化锌含量测定，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，氧化锌在6.0~56.5 mg范围内线性关系良好，线性方程Y=0.245 196 X+0.050 564（R=0.999 4）；氧化锌检出限为0.13 mg，定量限为0.43 mg；精密度试验氧化锌重复性实验相对标准偏差（RSD）为1.5%（n=6)，氧化锌中间精密度RSD为1.3%（n=12）；所有加标水平氧化锌平均回收率为100.3%（RSD=2.7%）。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氧化锌的含量测定。 |
| 关键词: 复方乳酸依沙吖啶软膏 氧化锌 含量测定 络合滴定法 |
| DOI：doi:10.13407/j.cnki.jpp.1672-108X.2024.02.001 |
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| 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 |
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| Determination of Zinc Oxide in Compound Ethacridine Lactate Ointment by Complexometric Titration |
| Zhang Jian1, Wang Xiaoling1, Wei Jinghai1, Liu Zongyang1, Li Yunqing2, Wang Hailun1, Wang Wenli1, An Fang1 |
| ((1. Beijing Children’s Hospital, Capital Medical University, Beijing 100045, China; 2. Beijing Traditional Chinese Medicine Hospital, Beijing Capital Medical University, Beijing 100169, China)) |
| Abstract: |
| Objective: To establish a determination method of zinc oxide in compound ethacridine lactate ointment. Methods: Content of zinc oxide in the same batch of compound ethacridine lactate ointment was determined by complexometric titration, and the specificity, linear range, precision and accuracy were analyzed to judge the applicability of the method. Results: The method was specialized. Zinc oxide was linear related in the mass range from 6.0 to 56.5 mg. The linear equation was Y=0.245,196 X+0.050,564 (R=0.999,4). The limit of zinc oxide detection was 0.13 mg, and the quantitative limit was 0.43 mg. The repetitive RSD (relative standard deviation) of zinc oxide in precision experiment was 1.5% (n=6), with intermediate precision of 1.3% (n=12). The average recycle rate of each additive amount of zinc oxide in accuracy test was 100.3% (RSD=2.7%). Conclusion: The method is simple, rapid, and the results are in accordance with the requirements of general rule 9101 in Pharmacopoeia of People’s Republic of China (2020 Edition), which is suitable for the determination of zinc oxide in compound ethacridine lactate ointment. |
| Key words: compound ethacridine lactate ointment zinc oxide content determination complexometric tritration |
