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三七伤药片的质量控制研究

The Quality Control Research of Sanqi Shangyao Pian

【作者】 彭江云

【导师】 饶高雄;

【作者基本信息】 云南中医学院 , 中药学, 2016, 硕士

【摘要】 本论文由四章组成。第一章为前言,第二章介绍了三七伤药片中君药三七的质量控制指标研究,第三章介绍了三七伤药片中骨碎补和赤芍的质量控制指标研究,第四章为三七伤药片质量标准研究综述。三七伤药片为《中国药典》收载中药复方制剂特色品种,具有舒筋活血,散瘀止痛之功效。用于跌打损伤,风湿瘀阻,关节痹痛;急慢性扭挫伤、神经痛见上述征候者。处方组成:三七,制草乌,雪上一枝蒿,冰片,骨碎补,红花,接骨木,赤芍;方中药材多为骨科特色药材,药效显著。鉴于三七伤药片质量控制标准研究的不完整性及局限性,本论文针对三七伤药片君药三七的3个主要成分:人参皂苷Rg1、Rb1及三七皂苷R1,利用薄层色谱技术对其进行定性鉴别方法研究,建立准确、快速的薄层鉴别方法;利用高效液相色谱技术对其所含三七皂苷R1和人参皂苷Rg1、Rb1进行定量测定方法研究,以色谱峰面积对进样量进行回归,R1、Rg1和Rb1的回归方程分别为:y=7.5134×104x+1225(R2=0.9999)、y=2.0575×104x-1384(R2=1)、y=2.2012×104x-1643(R2=1);R1、Rg1和Rb1对照品分别在如下范围呈良好线性关系:0.2447~1.2234 ug、0.8384~4.1918 ug、0.8287~4.1436 ug。平均加样回收率分别为97.86%(RSD=1.88%)、99.12%(RSD=1.78%)、98.50%(RSD=1.87%),该法准确度高,稳定性好。对组分骨碎补中的柚皮苷和赤芍中的芍药苷,利用薄层色谱技术分别对其进行定性鉴别方法研究,建立准确、快速的薄层鉴别方法;利用高效液相色谱技术对其所含柚皮苷和芍药苷进行定量测定方法研究,以色谱峰面积对进样量进行回归,柚皮苷和芍药苷的回归方程分别为:y=1.0482×103x-1046.6(R2=0.99)、y=3.6045×102x-425.37(R2=0.99);柚皮苷和芍药苷对照品分别在如下范围呈良好线性关系:2.3032~34.5480 ug、2.0594~30.8910 ug。平均加样回收率分别为103.67%(RSD=1.77%)、104.45%(RSD=1.32%),该法准确度高,稳定性好。

【Abstract】 This thesis consists of four chapters. The chapter 1 is preface. The chapter 2 studies on quality control of research for Sanqi component of Sanqi Shangyao Pian. The chapter 3 studies on quality control of research for Gusuibu & Chishao component of Sanqi Shangyao Pian. The chapter 4 is reviewed for Sanqi Shangyao Pian quality standards research.Sanqi Shangyao Pian is of compound preparations for traditional Chinese medicine, "Chinese Pharmacopoeia" is recorded. It has the function & indication of relaxing tendons and scattered stasis pain. Used for injuries, rheumatism stasis resistance, joint certification of pain; Acute or chronic torsion contusion, neuralgia, see the signs. The composition of prescription: Sanqi, Zhicaowu, Xueshangyizhigao, Bingpian, Gusuibu, Honghua, Jiegumu, Chishao. The party more are for orthopedic characteristic medicine, efficacy significantly.In view of Sanqi Shangyao Pian of quality control standards is limited. This paper is for the three main ingredients of the gentleman medicine components of Sanqi: panaxnotoginseng saponins R1 and ginseng saponin Rg1 & Rb1, applicating of thin layer chromatography for qualitative identification method, to establish an accurate and rapid method for the identification of thin layers. The method of quantitative determination of panaxnotoginseng saponins R1, ginsenoside Rg1 & Rb1 by high performance liquid chromatography was studied. Of the quantity of sample regression by chromatographic peak area, the regression equation of the R1, Rg1 and Rb1, respectively: y=7.5134×104x+1225.8( R2=0.9999), y=2.0575×104x-1384.8(R2=1), y=2.2012×104x-1643.2(R2=1); R1, Rg1 and Rb1 reference substance respectively had good linear relationship in the following range: 0.2447 ~ 1.2234 ug, 0.8384 ~ 4.1918 ug, 0.8287 ~ 4.1436 ug. The average recoveries were 97.86%(RSD=1.88%), 99.12%(RSD=1.78%), 98.50%(RSD=1.87%). The method has high accuracy and good stability.For the ingredients of naringin in Gusuibu and paeoniflorin in Chishao, respectively applicating of thin layer chromatography for qualitative identification method research, to establish an accurate and rapid method for the identification of thin layers. The method of quantitative determination of naringin, paeoniflorin by high performance liquid chromatography was studied.By chromatographic peak area to return sample quantity, the regression equation of naringin and paeoniflorin, respectively: y=1.0482×103x-1046.6(R2=0.99), y=3.6045×102x-425.37(R2=0.99).Naringin and paeoniflorin reference substance respectively had good linear relationship in the following range: 2.3032 ~ 34.5480 ug, 2.0594 ~ 30.8910 ug. The average recoveries were 103.67%(RSD=1.77%), 104.45%(RSD=1.32%). The method has high accuracy and good stability.

  • 【分类号】R286.0
  • 【被引频次】1
  • 【下载频次】311
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