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摘要：铁缺乏是世界上最常见的营养疾病。硫酸亚铁是一种生物利用率高且价格低廉的铁营养强化剂, 但这种铁盐性质活泼, 容易氧化变色, 产生异, 因此需要将其制备成便于服用的制剂。微丸是直径小于1.5mm的球形或类球形颗粒制剂，它具有流动性好，易填装胶囊，装量差异小，释药稳定等特点。微丸在药剂学领域中的应用十分广泛，作为药物的载体，它既可以进一步压制成片剂，又可填充胶囊，不仅提高了药物稳定性，而且可有效地调节药物释放速率。硫酸亚铁微丸不仅可以作为一种口服制剂，而且可以直接加入食物中，以作为解决乳制品、面制品中铁营养强化的一种有效途径。本论文主要研究内容是以微晶纤文素和乳糖作为辅料，以聚吡咯烷酮K30作为粘合剂，采用流化床制粒法制备硫酸亚铁微丸；考察相关的制备工艺，并对微丸的性能进行了考察，为进一步的研究提供数据支持。制备硫酸亚铁微丸的最佳工艺条件为：进风温度60℃、蠕动泵流速1.0~2.0mL/min、雾化压力0.04~0.1 mpa、风机频率为25Hz、粘合剂水溶液浓度30 g/mL；制得的硫酸亚铁微丸流动性较好、药物的均匀度良好，在粘合剂中加入抗氧化剂柠檬酸可显著减少硫酸亚铁的氧化。35677
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毕业论文关键词：工艺参数；物料参数；微丸；硫酸亚铁
Preparation of ferrous sulfate pellets
Abstract: Iron deficiency is the most common nutritional disease in the world.. Ferrous sulfate is a biological utilization rate of high and low price of iron nutrition fortifier, but the iron nature lively, easy oxidation discoloration, produce peculiar smell. Therefore, it is necessary the prepared for taking the preparation. Micro pellets diameter less than 1.5 mm spherical or quasi spherical particles preparation. It has good fluidity, easy filling capsules, load small differences in release drug stability etc. characteristics. Pellets in the pharmacy field is widely used, as a drug carrier, it can further compressed into tablets, and capsule filling, not only improve the drug stability, and can effectively adjust the drug release rate. The iron pellets can be used as an oral preparation and can be added directly to food as an effective way to strengthen iron nutrition in milk and flour products. The main content of this thesis is with microcrystalline cellulose and lactose as accessories to pyrrolidone K30 as a binder, ferrous sulfate pellets were prepared by fluidized bed granulation; investigation related to the preparation process, and on the performance of the micro pill were investigated, to provide data support for the further research. Preparation of ferrous sulfate pellets of the optimum preparation process for: inlet air temperature is 60 DEG C, velocity of peristaltic pump 1.0~2.0mL/min, atomization pressure MPa 0.04~0.1, wind machine frequency of 25Hz, binder concentration was 30g/ml; preparation of ferrous sulfate micro pill liquidity better, drug good uniformity, in the adhesive added antioxidants citric acid can significantly reduce the oxidation of ferrous sulfate.
Keywords: process parameters; material parameters; pellet; ferrous sulfate
目录
1 引言1
1.1 微丸的分类1
1.1.1 速释微丸2
1.1.2 骨架型控释微丸2
1.1.3 膜控型微丸3
1.1.4 膜控-骨架型微丸3
1.2 微丸的制备方法3
1.2.1 包衣锅法制备微丸3
1.2.2 沸腾床制粒包衣法制备微丸3
1.2.3 流化床制粒法制备微丸3
1.2.4 液相法制备微丸4
1.2.5 震动喷嘴装置法制备微丸4
1.2.6 挤出-滚圆法制备微丸4
1.2.7 熔融法制备微丸5
1.3 辅料的概述5
1.3.1 蜡质及不溶性阻滞剂5
1.3.2 熔融粘合剂5
1.3.3 薄膜材料5
1.3.4 增塑剂6
1.3.5 微晶纤文素6
1.3.6 乳糖6
1.4 铁离子含量分析方法7
1.4.1邻二氮杂菲法测定铁含量7