柴丹解郁颗粒的药学部分研究-药剂学专业论文.docxVIP

中 文 摘 要 柴丹解郁颗粒是由柴胡、丹参、延胡索、郁金、酸枣仁五味中药制成的 复方制剂，具有疏肝解郁、活血安神、清心泻火的功效，本方主治肝郁、血 瘀、气郁化火所致的失眠，抑郁焦虑，头痛等各种神经症及神经障碍，在临 床已使用多年，经数千例患者使用，药效得到充分肯定。本课题在中医药理 论的指导下，应用现代制药技术，并依据国家药品注册管理办法，对制剂的 制备工艺，质量标准和稳定性试验进行了系统研究。 根据处方的功能主治及药物所含成分的理化性质，拟定了工艺路线，采 用单因素筛选法考察郁金挥发油的提取工艺，用正交试验以多指标综合评分 方法优选丹参、柴胡、延胡索醇提工艺和酸枣仁、丹参醇提后的药渣的水提 工艺，确定了适宜提取方法及工艺条件。对浓缩、干燥、成型工艺条件及辅 料进行了相应的考察，确定了柴丹解郁颗粒的制备工艺。研究制定了制剂的 质量标准，对方中四味药进行了薄层色谱鉴别研究，最终以丹参、柴胡、延 胡索的鉴别方法简便，重现性和专属性良好而收入标准；采用高效液相色谱 法同时对制剂中丹参酮ⅡA 和丹酚酸 B 进行含量测定，进行了系统的方法学研 究，试验结果均符合要求，根据多批样品的测定结果，制订了丹参酮ⅡA 和丹 酚酸 B 的含量限度，暂定本品每袋含丹参酮ⅡA 不得少于 2. 5mg，含丹酚酸 B 不得少于 40mg。 采用常温留样考察进行了制剂的长期稳定性试验。研究结果表明：该制 剂制备工艺合理可行，质量标准可控，成品质量基本稳定。 关键词：柴丹解郁颗粒 制备工艺 质量标准 长期稳定性 Abstract Chaidan jieyu Granule is a compound preparation which consists of five Chinese herbs(Radix Bupleuri, Radix et Rhizoma Salviae Miltiorrhiza, Rhizoma Corydalis, Radix Curcumae, Semen Ziziphi Spinosae). It has the functions of dispersing the stagnated liver-Qi to relieve restless, promote blood circulation for tranquilization, clear away heat-fire. using in treating insomnia, worriment, headache and all kinds of nerval symptom because of depressing liver, Qi ,and blood. Under the guidance of Traditional Chinese medicine theory, applying modern pharmaceutical technology and according to correlative regulations of patent traditional Chinese medicine, we systematically studied the Preparation process, Quality standard and Preliminary Stability . On the basis of the function and treatment as well as the characers of the effective component of the herbs, the preparation process is designed to studying the extraction of volatile oil, alcohol-extract and water-extract, the optimum extract conditions about alchohol-extract and water-extract were selected by using orthogonal design which use quite a few assessing norms to evaluate them comprehensively. At the same time the optimal condensing and moulding conditions were screened. The quality standard was set up, which includes the thin layer chromatography identification of three