【作者】 胡波；

【导师】 方梅；

【作者基本信息】 四川大学 ， 药物分析， 2007， 硕士

【摘要】 腰息痛胶囊是由白芷、草乌（制）、续断、牛膝、三七、威灵仙、秦艽、杜仲、何首乌、桑寄生、当归、赤芍等22味中药和化药对乙酰氨基酚组成的中西药复方制剂。本文对腰息痛胶囊质量控制进行了全面研究，为腰息痛胶囊的质量控制奠定了基础。1．对腰息痛胶囊中各味药的化学成分和药理作用进行了深入的研究和分析。建立了腰息痛胶囊中的多味中药的薄层层析（TLC）鉴别方法，包括白芷、三七、杜仲、牛膝、威灵仙、当归和赤芍。其色谱斑点清晰，重复性好，专属性强，此方法的确立为腰息痛胶囊的定性鉴别提供了依据。2．进行了三批试制样品的制剂通则检查，分别测定了水分、装量差异、崩解时限和微生物限度等项目，结果均符合规定通则要求。3．建立了反相高效液相法测定腰息痛胶囊中欧前胡素的含量。采用Shim—pack vp—DOS（4.6×150mm，5μ）C₁₈色谱柱，以乙腈—水（52：48）为流动相，检测波长为248nm，试验结果表明，欧前胡素与其它成分峰达到基线分离，进样量在0.0983—1.5728μg之间时，峰面积和进样量线性关系良好，相关系数r值为0.9999，回收率为98.58％，RSD为1.20％，方法准确度高，耐用性好。并对白芷药材中欧前胡素的进行了相应的含量测定。4．建立了反相高效液相法测定腰息痛胶囊中对乙酰氨基酚的含量，采用Shim—pack vp—DOS（4.6×150mm，5μ）C₁₈色谱柱，以甲醇—水（24：76）为流动相，检测波长为257nm，试验结果表明，进样量在0.115—3.68μg之间时，峰面积和进样量线性关系良好，相关系数r值为0.9999，回收率为99.32％，RSD为0.87％，方法准确度高，耐用性好。5．建立了腰息痛胶囊中乌头碱TLC限度检查的方法。操作简便，专属性强。更多还原

【Abstract】 Yaoxitong capsule is composed with 22 kinds of traditional Chinese Medicine（include Dahurian Angelica Root, Kusnezoff Monkshood Root, Himalayan Teasel Root, Twotoothed Achyranthes Root, Sanchi etc.）and paracetamol. This paper is about integrated quality assessment for Yaoxitong capsule, and the results are provide basis for establish method to control quality of Yaoxitong capsule.1. To analyze and research chemical composition and pharmacological action for each consist of Yaoxitong capsule. In this paper, Dahurian Angelica Root, Sanchi, Eucommia Bark, Twotoothed Achyranthes Root, Chinese clematis root, Chinese Angelica and Red Peony Root in Yaoxitong capsule were identified by TLC with the posts clear, reproducible and only, it was effective to differentiate these materials in Yaoxitong capsule.2. We checked the moisture, weight variation, time limit and microbial limit for disintegration of three samples Yaoxitong capsule, the results were according with order.3. To establish method to determined imperatorin content in Yaoxitong capsule by HPLC. The chromatography is performed on a Shim—pack vp—DOS C₁₈ column （4.6×150mm, 5μ） with acetonitrile—water （52:48） as the mobile phase and the absorbance was monitored at 248 nm. The calibration curve was linear in the range of 0.0983—1.5728μg with the correlation coefficient 0.9999. The mean recovery was 98.58% （RSD= 1.20%）. The same method to determine imperatorin content in Dahurian Angelica Root for control quality of Yaoxitong capsule.4. To establish method to determined paracetamol content in Yaoxitong capsule by HPLC. The chromatography is performed on a Shim—pack vp—DOS C₁₈ column （4.6×150mm, 5μ） with Methanol—water （24:76） as the mobile phase and the absorbance was monitored at 257 nm. The calibration curve was linear in the range of 0.115—3.68μg with the correlation coefficient 0.9999. The mean recovery was 99.32% （RSD= 0.87%）.5. Establish TLC to aconitine limit test in Yaoxitong capsule. The method is convenient and specificity.更多还原