论文部分内容阅读
目的 研究醋酸地塞米松静注乳剂的处方及制备工艺 ,并对其性质进行考察。方法 以国产注射用大豆磷脂、泊洛沙姆 (poloxamer)为复合乳化剂 ,加入适量的稳定剂及助表面活性剂 ,用正交设计筛选出较优的处方及工艺 ,并经过中试放大制备出醋酸地塞米松静注乳剂。结果 制备的乳剂符合中国药典 2 0 0 0年版对静注乳剂的要求 ,与日本产品相比 ,粒度分布无明显差异 ,30℃下考察 6个月 ,物理及化学性质稳定。结论 筛选出的处方工艺经中试放大制备的静注乳剂性质稳定 ,为此产品的开发奠定基础
Objective To study the prescription and preparation technology of intravenous dexamethasone acetate emulsion and study its properties. Methods The domestic injection of soybean phospholipid and poloxamer as the composite emulsifier, adding the appropriate amount of stabilizer and cosurfactant, using orthogonal design screening out the better prescription and process, and after the pilot scale amplification preparation Dexamethasone intravenous emulsion. Results The prepared emulsion complied with the requirements of the Chinese Pharmacopoeia 2000 edition for intravenous emulsion. Compared with Japanese products, there was no significant difference in particle size distribution. After 30 minutes of 6 months observation, its physical and chemical properties were stable. CONCLUSIONS The prescriptions of the selected prescriptions are stable in nature and have laid the foundation for the development of this product.