复方青银片工艺及质量标准研究-药物化学专业毕业论文.docx

成都中医药大学硕士毕业论文
中文摘要
复方青银片由中药大青叶、金银花、山豆根和西药对乙酰氨基酚、马来酸氯苯那敏、维生素c等药组成,主要用于风热感冒, 流行性感冒。本实验通过工艺和质量标准研究,筛选出复方青银片的最佳工艺路线及工艺条件,进行三批中试生产,结果表明, 制剂工艺合理可行。并制定了质量标准,进行了初步稳定性试验。结果表明成品质量可控,性质稳定。
制各工艺研究采用正交试验方法,筛选出中药部分的最佳水提工艺。通过单因素试验,得出最佳除杂、浓缩干燥条件。考虑到处方中各药的性质,采用干法制粒、压片,通过试验筛选出最佳辅料及其用量。
质量标准中建立了大青叶、山豆根、对乙酰氨基酚、马来酸氯苯那敏、维生素C的薄层鉴别方法:各项检查均符合片剂项下的要求;用高效液相色谱法测定了制剂中绿原酸、对乙酰氨基酚、维生素C的含量,方法简单、专属性强、重现性好。并对腺苷和马来酸氯苯那敏的含量测定作了考察。
三批中试样品经初步稳定性试验考察,各项考核项目均符合规定,考察结果表明本品基本稳定。
关键词:复方青银片制各工艺质量标准
复方青银片工艺及质量标准研究
Abstract
Compound QingYin tablet consisits of Chinese herb Folium Isatidis,Flos Lonicerae,Radix Sophorae Tonkinensis,and chemical medicine Paracetamol,Chlorphenamne is applied mainly to treat rheum and rheum preparation process of this product were quality standard was established and the preliminary stability was test of quality and the basic stability of three batchs of tablets have showed that the production technique was reasonable and practical,the quality
was the quality ofthe end product was stable.
In the stud)7 of the preparation process,the optimum water extracting condition of the Chinese herb was selected by orthogonal we have explored the best conditions of the purification,extration and concentration methods by single—factor experiment was carried out on the adjuvant and the manufacturing process of to the experiment
results and the characters ponents in the preparation,we cail
determine the type and dosage of adjuvant,also the manufacturing
process was ascertained.
The quality standard established the thin chromatography identifiction of Folium Isatidis,Radix Sophorae Tonkinensis, Paracetamol,Chlorphenamne Maleale,Vitamin C,and every checks all meets the standard of the content of’ Chlomgenic Acid,Paracetamol,Vitamin C in the preparation were measured by High performance liquid studies showed that th