肺结核丸的质量控制方法研究中药学专业论文.docxVIP

研究生优秀毕业论文 相应的位置上，显相同颜色的荧光斑点，阴性样品色谱在与对照药材、 相应的位置上，显相同颜色的荧光斑点，阴性样品色谱在与对照药材、 对照品色谱相应的位置上不显任何颜色的斑点。 (2)含量测定中，二苯乙烯苷在289．5～4342ng范围内与峰面积呈 良好的线性关系，回归方程Y=3000．2064X+264097．5013(r为0．9995)； 平均回收率为98．61％(n=6)；RSD值为0．79％。在分析浓度下，24小时 内基本稳定(RsD=O．88％)。 (3)建立了肺结核丸HPLC指纹图谱测定方法，通过lO批样品确定 了10个共有峰，鉴别了其中4个共有峰，初步确定了8个共有峰的归 属，10批样品相似度在0．908～0．989之间。 结论：(1)薄层色谱法鉴别处方中三味药材，其鉴别方法快速简便， 各斑点清晰、圆整，分离度良好，无阴性干扰，可作为肺结核丸的定性 鉴别方法。 (2)高效液相色谱法测定肺结核丸中二苯乙烯苷的含量，其方法简 便快速，准确可靠，可用于肺结核丸的质量控制。 (3)所建立的肺结核丸HPLC指纹图谱测定方法，经方法学考察证 实，具有良好的精密度、重现性和稳定性，各共有峰间分离度良好，为 有效地控制肺结核丸的质量提供试验依据。 关键词：肺结核丸，定性鉴别，含量测定，指纹图谱 万方数据 Study Study on the Quality Control Method of Feijiehe Pills ABSTRACT Objective：The quality standard of Feijiehe Pills is recorded in the ninth volume of Preparation Standard for Chinese patent medicine issued by Sate Ministry of Public Health(1994)．The current quality standard is not perfect，it only contains the microscopic identification，the weight variation and the time limit of dissolution，it has been unable to meet the requirements of the modernization of traditional Chinese medicine quality control，it call not effectively control the comprehensive quality of medicines，the quality and safety of medicines can not be fully guaranteed．Therefore，based on the current quality standard，this paper made systematic study on determination method for traits identification，content determination and HPLC fingerprint of Feijiehe pills，in order to provide the experimental basis for the scientific evaluation of its quality Methods：(1)Using the thin—layer chromatography to carry on the the qualitative distinction of Polygonum Multiflori Radix Praeparata，Bletillae Rhizoma，Eupolyphaga Steleophaga in Feijiehe Pills．Polygonum Multiflori Radix Praeparata：a silica gel G plate was adopted with developingsolvent consisted ofEthyl acetate，methanol and water(20：2：1)，inspected at 365nm． Bletillae Rhizoma：a silica gel G plate was adopted with developing solvent consisted of Cyclohexane，ethyl acetate and methanol(6：2．5：1)，an alcoboli