| 注射用尼莫地平脂肪乳的制备及质量研究 |
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| 引用本文： | 卢隆桂,谢依侨,司徒少金,张蜀,吕小迅,秦凌浩,程佳音,杨刘宇峰,杨帆.注射用尼莫地平脂肪乳的制备及质量研究[J].广东医药学院学报,2014(3):265-268. |
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| 作者姓名： | 卢隆桂 谢依侨 司徒少金 张蜀 吕小迅 秦凌浩 程佳音 杨刘宇峰 杨帆 |
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| 作者单位： | [1]广东药学院药剂学教研室,广东广州510006 [2]广州白云山明兴制药有限公司,广东广州510250 [3]广东药学院药物研究所,广东广州510006 [4]广东药学院微生物学与免疫学教研室,广东广州510006 |
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| 基金项目： | 广东省教育部产学研结合项目（2011B090400164）; 广州市重大科技计划项目（201300000046） |
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| 摘 要： | 目的制备尼莫地平脂肪乳,并对其质量进行研究。方法通过二步乳匀法制备尼莫地平脂肪乳,并对其pH值、粒径分布、Zeta电位、酸值、过氧化值和药物质量浓度进行测定。结果所制备的乳剂外观呈乳白色,pH值为6.5-7.0,平均粒径约为180 nm,Zeta电位约为-45 mV,酸值为3.87 mmol/L,过氧化值符合规定,药物质量浓度约为0.8 mg/mL。结论自制尼莫地平脂肪乳的理化性质符合国家相关质量标准检查项目的要求。
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| 关 键 词： | 尼莫地平 脂肪乳 质量研究 酸值 过氧化值 |
Preparation and quality investigation of injectable nimodipin fat emulsion |
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| Authors: | LU Longgui XIE Yiqiao SITU Shaojin ZHANG Shu LYU Xiaoxun QIN Linghao CHENG Jiayin YANG Liuyufeng YANG Fan |
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| Institution: | 1.Department of Pharrnaeeuties ; 3. Drug Research Institute ; 4. Deparmentt of Microbiology and Immunology, Guangdong Pharmaceutical University, Guangzhou 510006, China; 2. Guangzhou Baiyunshan Mingxing Pharmaceutical Company Limited, Guangzhou 510250, China) |
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| Abstract: | Objective To prepare nimodipine fat emulsion and study its quality.Methods Nimodipine fat emulsion was prepared by two-step homogenization.The pH,particle size distribution,Zeta potential,acid value, peroxide value and drug content of nimodipine fat emulsion were determined.Results The appearance of the prepared fat emulsion was milky white.The pH value was between 6.5-7.0.The average particle size was about 180 nm and the Zeta potential was about-45 mV.Acid value was 3.87 mmol/L and drug content was about 0.8 mg/mL.Conclusion The prepared nimodipine fat emulsion meets the relevant national quality standards. |
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| Keywords: | nimodipine fat emulsion quality investigation acid value peroxide value |
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