姜雪敏,杨立志.小儿吐泻宁质量标准中含量测定研究[J].中国药事,2017,(8):940-943 |
小儿吐泻宁质量标准中含量测定研究 |
Study on the Assay Method for Xiaoertuxiening Quality Standard |
投稿时间:2016-08-18 |
DOI:10.16153/j.1002-7777.2017.08.018 |
中文关键词: 中药制剂 质量标准 小儿吐泻宁 厚朴酚 和厚朴酚 高效液相色谱法 |
英文关键词: Chinese medicine preparations quality standard Xiaoertuxienin particles Magnolol Honokiol HPLC |
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中文摘要: |
目的:小儿吐泻宁的质量标准中无含量测定项目,本文建立小儿吐泻宁中厚朴酚与和厚朴酚的含量测定方法,为该药品的质量标准修订提供参考。方法:采用高效液相色谱法,ZORBAX SBC18色谱柱,以甲醇-水(70:30)为流动相,检测波长为294 nm,流速为1.0 mL·min-1。结果:厚朴酚进样量在0.0403~0.8056μg内与峰面积具有良好的线性关系(r=1.0000)、和厚朴酚进样量在0.0604~1.2074μg内与峰面积具有良好的线性关系(r=1.0000),厚朴酚的平均回收率为97.8%,RSD=1.5%;和厚朴酚的平均回收率为98.0%,RSD=1.0%。厚朴酚含量为1.43 mg·袋-1,和厚朴酚含量为4.19 mg·袋-1。结论:本文建立的方法符合方法学验证要求,可为小儿吐泻宁的质量标准含量测定项目修订提供参考。 |
英文摘要: |
Objective: There is no determination in quality standard of Xiaoer tuxiening. In this paper, we set up a method for determination of magnolol and honokiol to provide references for the revision of the quality standard of this medicine. Methods: To establish a method by HPLC, the separation was performed on a ZORBAX SB-C18 column by using Methanol-Water (70:30) as mobile phase. The UV detection was set at 294nm; flow rate was 1.0mL·min-1. Results: The magnolol was in good linearity between the peak area and injection volume in the ranges of 0.0403~0.8056 μg (r=1.0000); The honokiol was in good linearity between the peak area and injection volume in the ranges of 0.0604~1.2074 μg (r=1.0000); The average recovery of magnolol was 97.8%, RSD=1.5%; The average recovery of honokiol was 98.0%, RSD=1.0%. The content of magnolol was 1.43mg·package-1, and honokiol content was 4.19mg·package-1. Conclusion: The method meets its validation requirements, and can provide references for the revision of the quality standard of Xiaoertuxienin. |
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