有关厄贝沙坦和氢氯噻嗪的处方研发和工艺的研究的论文.doc

复方降压药物HT-1的制剂工艺研究
作者:黎湖升
指导教师:李永辉张彩云
摘要: 目的:制备出一种治疗高血压的复方制剂。方法:通过查阅相关文献专利与分析对照药的理化性质,来制定这种复方制剂的处方,得到试验方向。从实验结果验证各个辅料、制备工艺和制备过程对处方的影响,筛选合适的辅料种类和用量,研究药物中活性成分的性质与作用机理,确定稳定的工艺和提高制剂的合格率。再根据对照药或药典给予的质量标准对其研发结果进行考核,确保研发结果有效准确。利用研发出的处方与工艺进行放大生产,通过测量脆碎度、崩解时间、降解产物、粒度大小分布、溶出度、含量均匀度等理化性质,验证制备工艺的可行性,并完善制备工艺。最终用符合质量标准的工艺,制备出复方片剂。将制备好的复方片剂与对照药的性质进行对比,检测复方制剂是否符合质量标准,确定制备出的复方片剂为合格的。结果:制备出的复方制剂符合质量标准。结论:该课题是使用一种系统有效的研究方法,所制备的复方制剂是合格的治疗高血压药物。
关键词:高血压;处方;工艺;
research on the preparation process pound HT-1preparation for hypertension
Author: Li Husheng
Tutors: Li Yonghui,Zhang Caiyun
Abstract: Objective To establish a treatment pound preparation for hypertension. Methods formulate the prescription through consult relevant literature、 patent and analysis of reference drug’s physicochemical properties . Confirm the effect of various material and product process from the experimental result to select suitable material ang the dosage, study the mechanism of action of the active constituents,ascertain an stable process and improve the acceptability of the the developed formulation and technology for scale-up production , by measuring the friability, disintegration time, degradation products, particle size distribution, dissolution, content uniformity and other physicochemical properties, verify the feasibility of the technology .using qualified product process to produce pound pare the pound with the reference to detect whether pound meets the quality Conclusion This task used a systematic and effective method,and the pound was qualified.
Key words:hypertension prescription crafts
目录
前言…………………………………………………………………………1第二章处方分析与设计……………………………………………………………2
2. 复方片剂的质量标准………………………………………………………………3
第三章处方筛选……………………………………………………………………6
辅料……………………………………………………………………………7
优化处方………………………………………………………………………8
辅料实验………………………………………………………………………8
仪器与试药………………………………………………………………8
仪器……………………………………………………………………8
试药…………………………………………………