楼黄胶囊的药学研究-生药学专业论文.docxVIP

中文摘要 中文摘要 中文摘要 楼黄胶囊是一种纯中药复方制剂，是由姜黄和重楼两种中药的有效部位组成， 具有较好的抗肿瘤效果，能够显著抑制肿瘤细胞生长。本课题对该复方制剂的制备 工艺和质量标准进行了系统的试验研究，同时对如何提高楼黄胶囊主要药效成分重 楼皂苷的吸收进行了初步的研究。 采用正交试验方法考察了重楼总皂苷的最佳提取工艺，即重楼药材用 8 倍量 60%乙醇，加热回流提取 3 次，每次 2h。利用大孔吸附树脂富集重楼皂苷，其工艺 流程为：每克药材所需湿树脂为 0.43 ml，提取液浓缩至 1:5 g 生药/ml，离心，上清 液通过已处理的药用级别的 D101 树脂柱，2 BV/h 作为吸附流速，30 %乙醇以 2 BV/h 流速洗脱 2 个树脂床体积，65 %，75 %的乙醇以 4 BV/h 流速各洗脱 3 BV，收集富 含重楼皂苷的洗脱液。姜黄药材用 10 倍量的水加热回流提取 3 次，每次 2h。重楼 总皂苷和姜黄水提液混合后，干燥，药粉与辅料等按比例 6:4 混合，加入适量的 85% 乙醇，制粒，干燥，整粒，装胶囊，即得楼黄胶囊。 在质量标准研究中，对楼黄胶囊复方中重楼皂苷进行了薄层色谱鉴别试验，采 用 HPLC 法测定重楼皂苷Ⅰ、Ⅱ、Ⅶ、H 和三个姜黄素类成分的含量，并进行了系 统的方法学考察。暂定本品每粒胶囊含重楼皂苷Ⅰ、Ⅱ、Ⅶ、H 的和不得少于 13 mg， 三个姜黄素类成分的和不得少于 1.2 mg。该制剂工艺合理可行，成品质量稳定可控。 为了提高重楼皂苷的在肠道内的吸收，研究了固体分散体和磷脂复合物的制备 方法，通过肠外翻囊实验比较其在大鼠小肠的吸收发现，泊洛沙姆 F127 制备的固 体分散体明显提高了重楼皂苷在水中的溶解能力，促进了重楼皂苷在小肠内的吸收， 从而一定程度上提高重楼皂苷的生物利用度，而磷脂复合物并没有明显提高重楼皂 苷的吸收。 关键词：楼黄胶囊、树脂、制备工艺、质量标准、吸收 AB ABSTRACT ABSTRACT Louhuang Capsule was a compound preparation of Traditional Chinese Medicine, and was composed of the effective compositions of Rhizoma paridis and Carcuma longa aqueous extract, which possesses good antitumor effect and capability of inhibiting growth of tumor cell obviously. The preparation technology and quality standard of Louhuang Capsule were studied systematically. The Rhizoma paridis saponins are the main active ingredients, and the preliminary study on new formulations of saponins was conducted to improve their absorption in rat intestine. According to the orthogonal experimental design, the optimum extracting conditions of saponins from Rhizoma Paridis was showed as following: extracting solvent was 60% ethanol, solid-liquid ratio was 1:8, extracting time was 2 h and extracting three times. The optimum parameters for the preparation of Rhizoma paridis saponins with D101 macroporous resin were confirmed as followed: for adsorption, 0.43 ml/g of the ratio of wet resin and raw medicine, 2.3 mg/ml of sample solution concentration, 2 bed volume/h of absorbtion flow rate; for desorption, 2 bed volume of ethanol–water (30:70, v/v)