安神温胆丸质量标准的的研究大的论文.docVIP

摘 要 安神温胆丸由半夏、陈皮、酸枣仁（炒）、远志、五味子、人参、竹茹、地黄、茯苓、枳实、朱砂、大枣和甘草组成。具有和胃化痰、安神定志的功效。临床用于治疗心胆虚怯、触事易惊、心悸不安、心悸不寐等症。安神温胆丸的质量状况直接关系到用药的安全性和有效性。建立安神温胆丸质量标准，采用薄层色谱法对安神温胆丸中的陈皮、五味子、人参、甘草、酸枣仁进行鉴别，用高效液相色谱法，采用Kromasil C18柱（4.6×250mm，5μm），以甲醇-水（60：40）为流动相，流速：0.8mL/min，检测波长为250nm，柱温：35℃；对五味子中五味子醇甲进行含量测定。结果显示：五味子醇甲的进样量在0.017-0.52μg范围内成良好的线性，r=1.0（n=5）。五味子醇甲的平均回收率为99.83%，RSD=0.86%（n=6）。得出结论，该方法操作简便，准确可靠，重现性好，可用于控制安神温胆丸的质量。 关键词： 安神温胆丸 质量标准 薄层色谱法 高效液相色谱法 含量测定 Abstract Anshenwendan Pill By the system Pinellia Tuberifera Tenore, Pericarpium Citri Reticulatae, Spine Date Seed (speculation), Polygala, Schisandra, Radixe Ginseng, Caulis Bambusae In Taenia, Chinese Foxglove, Fructus Aurantii Immaturus, Cinnabar, Fructus and Jujubae anLicorice,and stomach with phlegm, calm the nerves of the effectiveness of Dingzhi. Bile for the treatment of clinical heart weak, inconsistent things easy to panic and anxiety heart palpitations, insomnia and other symptoms of heart palpitations. Its direct bearing on the authenticity of the merits of clinical drug safety and efficacy. To establish a quality standard for Anshenwendan Pill. Pericarpium Citri Reticulatae, Fructus Schisandrae Chinensis, Radix et Rhizoma Ginseng, Radix et Rhizoma Glycyrrhizae and ziziphas jujuba mill were identified by TLC,and the content of Schisandrin was measured by HPLC. Kromasil C18 column (4.6×250mm, 5μm) was used, for the determination of the content of Schisandrin, the mobile phase was liquid of both methanol and water (60:40), flow rate was 0.8mL/min,and the detection wavelength was 250nm; the column temperature: 35℃. Results: The calibration curve of Schisandrin was linear over the range of giving Schisandrin between 0.017 and 0.52μg, with the correlation RSD=0.86% (n=6). Conclusion: The method is simple, accurate and highly repeatable.It is suitable for the quality control of the Anshenwendan Pill. Keywords: Anshenwendan Pill Quality Standard TLC HPLC Content - 目 录 摘 要 I Abstract II 目 录 III 1 前 言 1 1.1 安神温胆丸背景 1 1.2