辛芷鼻用喷雾剂的制备及质量标准的分析-preparation and quality standard analysis of xinzhi nasal spray.docxVIP

中文摘要 中文摘要 辛芷鼻用喷雾剂是由白芷、辛夷两味中药制成的复方制剂，具有 祛风燥湿、通利鼻窍的功效，主要用于治疗急、慢性鼻炎、变态反应 性鼻炎、鼻窦炎、感冒等引起的鼻阻塞。在中医药理论指导下，根据 大量的文献资料，结合处方中各药物成分的理化性质，依据国家药品 注册管理办法的规定，采用现代药学研究技术，对辛芷鼻用喷雾剂的 制备工艺、质量标准和初步稳定性试验进行了试验研究。 提取工艺研究中，分别以辛夷挥发油收率、白芷中欧前胡素含量 及干膏率为指标，采用单因素试验和正交试验相结合的方法对提取工 艺进行了考察；纯化工艺研究中，用大孔吸附树脂对白芷中香豆素类 化合物进行富集纯化，采用单因素考察法筛选出最佳纯化工艺，并建 立了白芷提取物的质量标准；成型工艺研究中，对鼻用喷雾剂中附加 剂的种类和用量进行了筛选，并确定了鼻用喷雾剂的制备工艺。 质量标准研究中，建立了白芷、辛夷的薄层色谱鉴别方法和欧前 胡素的含量测定方法，并对样品的稳定性进行了初步稳定性考察。 研究结果表明，辛芷鼻用喷雾剂制备工艺科学、合理、可行；质 量标准稳定、可控，制剂性质基本稳定。 关键词：辛芷鼻用喷雾剂 鼻阻塞 制备工艺 质量标准 Abstract Abstract Spraying Agent of Biond Magnolia Flower and Angelica Dahurica is a compound preparation contained Angelica dahurica and Biond magnolia flower. It has the function of dispelling wind and removing dampness. It is mainly to treat the nasal obstruction originated by acute rhinitis, chronic rhinitis, allergia nasitis ， nasosinusitis and catarrhal rhinitis. With the guidance of the theories of Traditional Chinese Medicine, on the basis of abundant literature materials, in combination with the property of each ingredient in this prescription, we systematically studied Preparation Process, Quality Standard and Preliminary Stability by according as the national drugs registration policing method and adopting the modern pharmacy research technology. In the study of preparation craftwork，with the yield of aetherolea of Biond magnolia flower, the content of imperatorin in Angelica dahurica and as the evaluation indexes, the single factor test and orthogonal test was adopted. The Macroporous Resin is used to purify and concentrate the Coumarins of Angelica dahurica, and the single factor test was adopted. The quality criteria of extractive of Angelica dahurica are also established. In the preparation process, the denomination and dosage of the supplemental agent in the spraying agent is bolted, and the preparation is ascertained. In Quality standard research, TLC was adopted to distinguish Angelica dahurica and Biond Magnolia Flower. HPLC method was adopted to