贯叶连翘提取物新制剂设计及其质量研究-植物学专业论文.docxVIP

质的筛选，溶出曲线的绘制，溶出规律的研究)、含量测定(总金丝桃素，总黄 质的筛选，溶出曲线的绘制，溶出规律的研究)、含量测定(总金丝桃素，总黄 酮，金丝桃素)。结果表明，普通片和薄膜衣片的质量相近，薄膜包衣工艺对制 剂的最终质量没有明显影响。 在稳定性研究中，进行了影响因素试验、加速试验和室温留样试验。结果表 明，普通片和薄膜衣片对高湿度环境(RH92％)不具有很好的稳定性，在加速试 验和室温留样试验中，普通片与薄膜衣片显示出相似的稳定性。 通过小鼠强迫游泳实验和小鼠悬尾实验，证实了贯叶连翘提取物制成的片剂 在抗抑郁方面是确有活性的。通过与空白对照和阳性对照比较，证明贯叶连翘普 通片或包衣片在实验剂量上的活性明显优于空白对照，且比阳性对照的活性更好 或者至少与其相当。比较普通片与原料药的活性、包农片与普通片的活性，各组 间没有显著性差异，证明在制剂过程中，无论是制片还是包衣工艺，对制剂的活 性均没有显著性影响。 国外上市产品主要是贯叶连翘的普通片和普通胶囊制剂，而本论文在研究制 剂成型工艺的基础上，更采用了制剂手段对片剂的质量进行保护。本论文的研究 结果为加快贯叶连翘制剂在国内的上市提供了基础。 关键词：贯叶连翘；薄膜包衣；微丸；片剂；质量评价：稳定性；药效学 Title：Study Title：Study On New Preparations ofHypericumpe咖ratum L．Extracts Speciality：Botany Name：Gan Liangchun Supervisor：Pm￡Yang Depo ABSTRACT Hypericum perforatum L．(HP)is a sort of wilding of Hypericum which belongs to Guttiferae．Modem phamaacology has proved the efficacy of HP in the mild to moderate depression．Today,HP has been successful in Germany and other European and American countries as the most salable herbal antidepressant。However,there are no relevant preparations in our country．In order to exploit the abundant HP resources and develop new antidepressants，HP preparations were studied with the lip from Our country as the material in this paper． Hypericins，hyperfofins and flavonoids contained in HP are the main active compositions for depression．Because of the instability of part active compositions to light，oxygen and heat，film—coating Was adopted to protect the preparations．We researched the feasibility that tihn—coated pellets and film—coated tablets were produced．We also evaluated the quality of the two preparations． During the research of film-coated pellets，the extract from HP served as the material．The formulations of the pellets and the film were optimized with the method of single factor investigation．The guidelines included the appearance，the feasibility of making pellets and coating them，the conglutination between the pellets，etc．The preparation technology was established．The items in the quality system offilm—