小儿咽扁颗粒中绿原酸的含量测定

小儿咽扁颗粒中绿原酸的含量测定

文档编号:SW021 文档字数:9104,页数:25

摘要：本文档建立小儿咽扁颗粒中绿原酸含量的测定方法。采用HPLC法测定小儿咽扁颗粒中绿原酸的含量，采用依利特Hypersil ODS柱，乙腈-0.2%磷酸溶液（10∶90）为流动相，流速为1.0mL/min，超声和回流提取绿原酸的效果相当，但超声方法简单，故选择超声作为提取绿原酸的方法，以50%甲醇作为提取溶媒，提取时间为20分钟，检测波长为327 nm。结果表明：绿原酸在1.016～101.6μg/mL之间呈良好的线性关系(γ=1)，绿原酸含量测定方法，进样精密度良好，绿原酸在50%甲醇中12小时之内稳定，绿原酸含量测定方法，重复性及日间精密度良好，平均加样回收率为98.6％(n=6)，RSD为0.55％。本法操作简便、易行、准确、重现性好，可用于该制剂的质量控制。
关键词：小儿咽扁颗粒；高效液相色谱；绿原酸

The Determination Of Chlorogenic Acid Content In Xiao’er Yan

Abstract: This article is about establishing a method of quality control for assaying chlorogenic acid in Xiao’ er yan bian particle.Xiao’ er yan bian particle was analysized by HPLC.An yi li te Hypersil ODS column was used with a mobile phase consisted of mixture of acetonitrile—0.2%phosphoric acid (10：90,by volume ratio)by flowing rate of 1.0mL/min in this method.The methods of extracting chlorogenic acid by hypersound and backstreaming were equivalented.The hypersound was more convenient ,so we chose hypersound as the method to extract chlorogenic acid. Using 50% (by volume ratio) methanol as the menstruum,the time of extracting was 20 minutes.And VWD detector wavelength was 327nm.The results suggested that the linear range of chlorogenic acid was 1.016～101.6μg/mL (r= 1).The precision of sample introduction was very good by this method and chlorogenic acid was steady in 50% (by volume ratio) methanol in 12 hours . The determination reproducibility and daytime degree of precision of the method were very good.The average recovery was 98.6％ (RSD=0.55％,n=6) . In Conclusion, this was an accurate, simple, rapid qualitative method with good reproducibility to assay chlorogenic acid in Xiao’ er yan bian particle.
Keywords：Xiao’ er yan bian particle；HPLC；Chlorogenic acid

目录
中文摘要 I
英文摘要 II
目录 III
1. 绪论 1
1.1 小儿咽扁颗粒简介 1
1.2 绿原酸简介 2
1.3 高效液相色谱法测定绿原酸含量综述 4
2. 实验部分 6
2.1 实验原料和仪器 6
2.2 色谱条件的选择试验 6
2.3 标准曲线的制备及线性范围的考察试验 7
2.4 精密度考察试验 7
2.5 提取方法的选择试验 7
2.6 提取溶媒选择试验 7
2.7 提取时间选择试验 7
2.8 绿原酸溶液的稳定性试验 7
2.9 重复性及日间精密度试验 8
2.10 回收率试验 8
2.11 绿原酸含量测定方法试验 8
2.12 阴性对照溶液的制备试验 9
2.13 样品的测定及含量限度的确定试验 9
2.14 药材的测定试验 9
2.15 药品标准物质的有关资料 9
3. 结果与讨论 10
3.1 色谱条件的选择 10
3.2 标准曲线的制备及线性范围的考察 11
3.3 精密度考察 12
3.4 提取方法的选择 13
3.5 提取溶媒选择 13
3.6 提取时间选择 13
3.7 绿原酸溶液稳定性试验 14
3.8 重复性及日间精密度 14
3.9 回收率 14
3.10 测定法 15
3.11 样品的测定及含量限度的确定 15
3.12 药材的测定 16
4. 总结与展望 17
致谢 18
参考文献 .19

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