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镇咳宁软胶囊的研制

The Research of Zhenkening Soft Capsules

【作者】 陆国胜

【导师】 牛泱平;

【作者基本信息】 浙江工业大学 , 制药工程, 2009, 硕士

【摘要】 中成药是中华民族宝贵的文化遗产,其疗效历经几千年的验证毋庸置疑。目前,随着社会的发展,科学的进步及生活水平的提高,人们对药品的关心度和需求量不断增加,中医药在治疗、康复、养生等方面的特色和优势也不断得到发挥,中药及天然药物的应用已经受到国内外的普遍重视,并以其特有的疗效和安全性正在逐渐为国际社会所接受。镇咳宁软胶囊是镇咳宁糖浆改变剂型而研制的新药。本研究确立了镇咳宁软胶囊有效成分的提取方法,选择恰当的赋形剂和适当的胶皮配比,确立压丸的成型工艺。确立采用甘草流浸膏、桔梗、盐酸麻黄碱3味药进行定性薄层鉴别,采用高效液相色谱法测定镇咳宁软胶囊中盐酸麻黄碱的含量,制定含量限度,研究镇咳宁软胶囊稳定性,以确认镇咳宁软胶囊是否符合要求。鉴于此,本研究在这方面进行了有益的尝试,以镇咳宁软胶囊为研究对象,运用新方法、新技术对其进行工艺改革,剂型优化,并采用现代分析手段进行质量控制,力求探寻中药现代化的可行性思路。本研究以中医药理论为指导,采用现代技术试验手段,对镇咳宁软胶囊进行二次开发,为中药现代化提供可靠的实验数据,从而为开发出剂型先进、质量可控、科技含量高,有国际竞争力的产品打下坚实的基础。

【Abstract】 Proprietary Chinese medicine is a valuable cultural heritage of Chinese. It’s no doubt about its efficacy after thousands of years of certification. Currently, with the development of society, scientific progress and improvement of the living standard, the people’s concern and demand for drugs are increasing. Chinese medicine has been playing a more and more important role of the characteristics and advantages in the treatment, rehabilitation, health and other aspects. The application of Chinese medicine and natural medicine has been taking the widespread attention by whole world. its unique efficacy and safety are being gradually accepted by the international community.Zhenkening soft capsules was changed and developed from Zhenkening Syrup as new drugs. This study established the town to cough rather the craft of Zhenkening soft capsules. The fabrication process used to Gancaoliujingao, Jiegeng, Ephedrini Hydrochloridtlm, three ingredients ephedrine hydrochloride the qualitative TLC. Zhenkening soft capsules using HPLC determination of the content of ephedrine hydrochloride capsules, The Zhenkening soft capsules limits of content was to confirm whether it meets the requirement of Zhenkening soft capsules.The present study, under the guidance of the Traditional Chinese Medicinal (TCM) theory and practice, using modern experiment technology and method, to redevelopment the Zhenkening soft capsules, which provides the reliable experiment datum for the traditional Chinese medicinal modernization, and set up the strong foundation for developing new product with advanced dosage form, quality controllable, the high technology content and owning the international competitive power.

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