【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)(250×4.6mm,5μm),流动相为甲醇-0.1%磷酸水溶液,梯度洗脱；流速为0.8mL·min-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)(250×4.6mm,5μm),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0.8mL·min-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)(250×4.6mm,5μm);流动相为乙腈-0.1mol·L-1醋酸铵(磷酸调pH至3.0),梯度洗脱；检测波长为335nm；流速为0.8mL·min-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)(250mm×4.6mm×5μm), mobile phase was methanol-0.1%phosphoric acid, with gradient elution; flow rate was0.8mL·min-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 x4.6mm×5μm), mobile phase was methanol-tetrahydrofuran-0.1%phosphoric acid (14:14:72), detection wavelength was335nm, flow rate wsa0.8mL·min-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)(250mm×4.6mm×5μm); 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 was0.8mL·min-1; column temperature was35℃.Results:The characteristics spots of the scutellarin in TLC were clear, without the negative interference, toxic ingredients pyromeconic acid shalln’t 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 similarity>0.99, 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6-8Abstract8-10引言11-13第一部分 质量标准研究13-531 样品收集情况132 鉴别项研究13-172.1 仪器与试药142.2 鉴别实验14-162.3 拟定方法的温湿度考察16-173 检查项研究17-353.1 焦袂康酸17-253.2 溶出度25-354 含量测定项研究35-474.1 仪器与试药35-364.2 对照品溶液的制备364.3 测定波长的选择36-374.4 流动相的选择37-384.5 供试品溶液的制备38-404.6 专属性考察40-414.7 线性关系考察414.8 进样精密度试验41-424.9 稳定性试验42-434.10 检测限434.11 定量限434.12 重复性试验43-444.13 回收率试验44-454.14 样品含量测定45-464.15 耐用性考察46-475 质量标准草案47-526 小结与讨论52-53第二部分 灯盏花素系列品种指纹图谱研究53-751 参照物531.1 参照物的选择531.2 参照物的制备532 仪器与试药53-543 实验过程54-593.1 供试品溶液的制备543.2 流动相的选择54-563.3 色谱柱的选择563.4 柱温的选择56-573.5 测定波长的选择57-583.6 色谱条件的确定58-594 指纹图谱的建立59-635 指纹图谱标准的确立635.1 色谱条件与系统适应性实验635.2 共有峰的确定635.3 评定标准636 指纹图谱的方法学验证63-746.1 精密度试验63-656.2 稳定性试验65-676.3 重复性试验67-686.4 色谱图谱的完整性68-696.5 专属性考察69-706.6 灯盏花素原料图谱70-736.7 耐用性考察73-747 小结与讨论74-75第三部分 总结和展望75-77致谢77-78参考文献78-80附录1 灯盏花素系列品种质量标准研究概况80-93参考文献89-93附录2 攻读学位期间主要研究成果及发表论文93
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