【关键词】灯盏花素分散片 灯盏花素滴丸 质量标准 野黄芩苷【英文关键词】Breviscapine dispersible tablets Breviscapine Dropping Pill Quality standards Wild yellow baicalin灯盏花素分散片论文：灯盏花素系列品种质量标准研究【中文摘要】对灯盏花素滴丸、灯盏花素分散片 2个系列品种进行质量标准研究并统一其质量标准,为灯盏花素系列品种提供质控依据。方法：通过薄层色谱法研究并统一两品种专属性的鉴别条件；采用高效液相色谱法对其可能存在的有毒成分焦袂康酸建立了检查方法,色谱柱为 Agilent C18(TC)(2504.6mm,5m),流动相为甲醇-0.1%磷酸水溶液,梯度洗脱；流速为 0.8mLmin-1,检测波长为270nm,柱温为 35；根据中国药典 2010年版二部附录 XC第二法,对两品种的溶出度项目进行检查,并确立了统一的测定方法；采用高效液相色谱法建立统一两品种的野黄芩苷含量测定方法,色谱柱为 Agilent C18(TC)(2504.6mm,5m),流动相为甲醇-四氢呋喃-0.1%磷酸溶液(14：14：72),检测波长为 335nm,流速为 0.8mLmin-1,柱温为 35；建立灯盏花素滴丸、分散片及灯盏花素原料的 HPLC指纹图谱分析方法。采用高效液相色谱法,色谱柱为 Agilent C18(TC)(2504.6mm,5m);流动相为乙腈-0.1molL-1 醋酸铵(磷酸调 pH至 3.0),梯度洗脱；检测波长为 335nm；流速为 0.8mLmin-1;柱温为 35。结果：野黄芩苷的薄层鉴别特征斑点清晰、阴性无干扰,其有毒成分焦袂康酸规定不得检出；在统一的溶出条件下,灯盏花素滴丸和灯盏花素分散片分别在 30min、20min 溶出限度为含量的 70%、80%；通过高效液相色谱法测定灯盏花素滴丸和灯盏花素分散片中野黄芩苷含量,测定方法专属性强、准确性和重复性好；应用“中药色谱指纹图谱相似度评价系统”对灯盏花素滴丸、灯盏花素分散片及灯盏花素原料各批次进行了质量评价,相似度均0.99,方法精密度、稳定性和重复性良好。结论：以灯盏花素系列品种为示范性研究品种研究其质量标准,为中药质量标准研究和信息化体系建设平台子课题中成药质量标准研究平台建设提供依据。【英文摘要】:To study the quality standards two series of varieties of Breviscapine Dropping Pill and breviscapine dispersible tablets,and to harmonize its quality standards,as to provide quality control basis to Breviscapine series of varieties.Method:Through thin layer chromatography to reunificate the exclusive identification conditions of the two varieties; using high performance liquid chromatography method to establish the examination method examing toxic ingredients pyromeconic acid exist probably, column was Agilent C18(TC)(250mm4.6mm5m), mobile phase was methanol-0.1%phosphoric acid, with gradient elution; flow rate was0.8mLmin-1, the detection wavelength was270nm, column temperature was35; reference to the second method of Chinese Pharmacopoeia2010edition two Appendix XC, two varieties of dissolution item to be checked, and established a unified determination; using high performance liquid chromatography to establish a unified method determining the scutellarin of two varieties, the column was Agilent C18(TC)(250mm x4.6mm5m), mobile phase was methanol-tetrahydrofuran-0.1%phosphoric acid (14:14:72), detection wavelength was335nm, flow rate wsa0.8mLmin-1, the column temperature was35; to establish HPLC fingerprint analysis method of Breviscapine Dropping Pill, dispersible tablets and Breviscapine raw materials. Using high performance liquid chromatography, column was Agilent C18(TC)(250mm4.6mm5m); mobile phase was acetonitrile-0.1mol-L-1ammonium phosphate(using acetic acid adjust to pH3.0), gradient elution; the detection wavelength was335nm; a flow rate was0.8mLmin-1; column temperature was35.Results:The characteristics spots of the scutellarin in TLC were clear, without the negative interference, toxic ingredients pyromeconic acid shallnt be detected; under the uniform dissolution conditions, the content of dissolution limits for Breviscapine Dropping Pill and breviscapine dispersible tablets were70%,80%at30minutes and20minutes, respectively; determining the content of the scutellarin of Breviscapine Dropping Pill and breviscapine dispersible tablets by High Performance Liquid Chromatography Method with good spccificity,accuracy and repeatability; appling the Traditional Chinese medicine chromatographic fingerprint similarity of evaluation system to assess the quality of the batches of Breviscapine Dropping Pill, breviscapine dispersible tablets and Breviscapine raw materials,the similarity0.99, the precision, stability and reproducibility of the method was good. Conclusion:Using series of varieties of Breviscapine as the demonstration varieties to study the quality standards,and for traditional Chinese medicine quality standards and sub-project of information system construction platform of proprietary Chinese medicines provide the basis.【目录】灯盏花素系列品种质量标准研究 中文摘要 6-8 Abstract 8-10 引言 11-13 第一部分 质量标准研究 13-53 1 样品收集情况 13 2 鉴别项研究 13-17 2.1 仪器与试药 14 2.2 鉴别实验 14-16 2.3 拟定方法的温湿度考察 16-17 3 检查项研究 17-35 3.1焦袂康酸 17-25 3.2 溶出度 25-35 4 含量测定项研究 35-47 4.1 仪器与试药 35-36 4.2 对照品溶液的制备 36 4.3 测定波长的选择 36-37 4.4 流动相的选择 37-38 4.5 供试品溶液的制备 38-40 4.6 专属性考察 40-41 4.7 线性关系考察 41 4.8 进样精密度试验 41-42 4.9 稳定性试验 42-43 4.10 检测限 43 4.11 定量限 43 4.12 重复性试验 43-44 4.13 回收率试验 44-45 4.14 样品含量测定 45-46 4.15 耐用性考察 46-47 5 质量标准草案 47-52 6 小结与讨论 52-53 第二部分 灯盏花素