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醋酸地塞米松静注乳剂的制备及性质研究
引用本文:全东琴 崔光华 等. 醋酸地塞米松静注乳剂的制备及性质研究[J]. 中国药学杂志, 2001, 36(4): 252-254
作者姓名:全东琴 崔光华 等
作者单位:[1]军事医学科学院毒物药物研究所,北京100850 [2]军事医学科学院毒物药物研究所,北京10085
摘    要: 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2000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。

关 键 词:醋酸地塞米松  静注乳剂  粒度分布
文章编号:1001-2494(2001)04-0252-03
收稿时间:2000-09-21;
修稿时间:2000-09-21

Studies on preparation and properties of intravenous dexamethasone acetate emulsion
QUAN Dong qin,CUI Guang hua,RUAN Jin xiu. Studies on preparation and properties of intravenous dexamethasone acetate emulsion[J]. Chinese Pharmaceutical Journal, 2001, 36(4): 252-254
Authors:QUAN Dong qin  CUI Guang hua  RUAN Jin xiu
Affiliation:Institute of Pharmacology and Toxicology, Academy of Military Medical Sciences, Beijing 100850,China
Abstract:OBJECTIVE To study the formulation and preparation technique of intravenous dexamethasone acetate emulsions and also investigate the properties.METHODS The emulsions were prepared using soybean phospholipids and poloxamer (F 68 ) as the complex emulsifying agent.The stabilized agent and cosurfactant were also added in the formulation.The formulation and preparation technique were selected by orthogonal method and had been amplified on large scale.RESULTS The physico chemical stability was good and the particle size and distribution were almost the same as the Japanese products.CONCLUSION The selected formulation and preparation technique were good and can contribute to the development of the product.
Keywords:dexamethasone acetate  emulsion   particle size
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