《洋金花胶囊的含量测定方法和指纹图谱研究》-毕业论文（设计）.doc

摘 要 洋金花为茄科植物白曼陀罗Datura metel L.的干燥花，是一味传统的中药。其制剂或复方在治疗银屑病上具有疗效好、复发率低、方法简便、疗程短等优点。 本文对五类新药洋金花胶囊的中间体，即洋金花治疗银屑病有效部位的质量标准进行了初步研究，制定了该中间体的质量评价方法。以3-O-β-D-葡萄吡喃糖基(1→2)葡萄吡喃糖基、7-O-α-L-鼠李吡喃糖基山柰酚为对照品，采用比色法对中间体中的总黄酮进行含量测定，以高效液相法对中间体中对照品进行含量测定。通过对10批洋金花胶囊中间体的含量测定，其总黄酮含量55.4%±0.31%，指标性成分含量3.4%±0.13%。因此建议以总黄酮含量52%，指标性成分含量3%作为洋金花胶囊中间体质量评价指标。该方法简便、易行，其测定结果可作为判定洋金花胶囊质量的依据之一。 本文同时对洋金花胶囊中间体进行了指纹图谱研究，建立了高效液相色谱指纹图谱的研究方法，并进行了方法学考察，确定了指纹图谱测定条件。通过对十批中间体指纹图谱的研究，确定了12个峰为指纹图谱的共有峰。以对照品为参照物，对其他色谱峰的相对保留时间和相对峰面积进行计算，作为技术参数评价中间体的质量。利用ExceL软件，依据相似度原理得出的不同计算方法，计算了十批中间体指纹图谱间的相似度。其中夹角余弦和相关系数值均大于0.95，加权欧式距离趋近于0，表明各批次间相似度高，该制剂的生产工艺稳定、可靠。 本文研究结果证明，通过对中间体质量标准和指纹图谱的研究，实现了对洋金花胶囊的中间体整体特征的表达，即定性与定量的结合，为建立洋金花治疗银屑病有效部位及其制剂洋金花胶囊的质量评价提供了可靠的依据和重要的基础。 关键词: 洋金花胶囊 质量标准 含量测定 指纹图谱 银屑病 ABSTRACT Flos Daturae is a traditional herb which is the dry flower of Datura metel L.. Medinces made of Flos Daturae in treating Psoriasis have many advantag es, such as marked curative effect,low relapse rate,simple and convenient method,short course of treatment. We studied the quality criterion of the effective part of yangjinhua capsu le which is the fifth type of new medicine and established the method to eval- uate the quality of half-production. The standard material is Kaempferol-3-O- β-D-glucopyranosyl(1→2)-β-D-glucopyranosyl、7-O-α-L-rhamnopyranoside. The total flavonoids were determined by colorimetric method. The standard material was determined by HPLC. The results are 55.4%±0.31% and 3.4% ±0.13% respectively. So we suggest the content of total flavanoids be 52% and standard material be 3%. The results can be used as the evaluating critetion. The fingerprint of yangjinhua capsule’s half-production was also studied. We not only set up the study method but also inspect the method and determi ne the experimental condition. Through the fingerprint study of ten batches ha lf-production , twelve peaks were defined as the common peaks. The relative time and relative area were calculated to the