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 m L·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。
Objective： There is no determination in quality standard ofXiaoer 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 oualitv standard of Xiaoertuxienin
出处
《中国药事》
CAS
2017年第8期940-943,共4页
Chinese Pharmaceutical Affairs
