复方青银片工艺及质量标准研究

【作者】 梁恒兴；

【导师】 董小萍； 郭力；

【作者基本信息】 成都中医药大学 ， 药物化学， 2004， 硕士

【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。 制备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。更多还原

【Abstract】 Compound QingYin tablet consisits of Chinese herb Folium Isatidis, Flos Lonicerae, Radix Sophorae Tonkinensis, and chemical medicine Paracetamol, Chlorphenamne Maleate, Vitamin C, etc. It is applied mainly to treat rheum and rheum epidemic. The preparation process of this product were screened, the quality standard was established and the preliminary stability was investigated. The 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 controllable, and the quality of the end product was stable.In the study of the preparation process, the optimum water extracting condition of the Chinese herb was selected by orthogonal experiment. Then we have explored the best conditions of the purification, extration and concentration methods by single-factor experiment. Contrast experiment was carried out on the adjuvant and the manufacturing process of tablets. According to the experiment results and the characters of the components in the preparation, we can 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 Maleate, Vitamin C, and every checks all meets the standard of the pharmacopeia. The content of Chlorogenic Acid, Paracetamol, Vitamin C in the preparation were measured by High performance liquid chromatography. The studies showed that these methods were sufficiently simple, sensetive and reproducible.Stability studies of three batchs of tablets demonstrated the every checks all meets the standard of the pharmacopeia, and the end product was stable.更多还原