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›› 2004, Vol. 4 ›› Issue (2): 150-154.

• 过程与工艺 • 上一篇    下一篇

微细硫酸沙丁胺醇颗粒的制备

续京,刘晓林,陈剑锋   

  1. 北京化工大学教育部超重力工程研究中心
  • 出版日期:2004-04-20 发布日期:2004-04-20

Preparation of Ultrafine Medicine Particles of Salbutamol Sulfate

XU Jing,LIU Xiao-lin,CHEN Jian-feng   

  1. 北京化工大学教育部超重力工程研究中心
  • Online:2004-04-20 Published:2004-04-20

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被引次数

36

摘要： 以沙丁胺醇和硫酸为反应物，在乙醇溶液中制备微细硫酸沙丁胺醇. 对影响产物粒径和产率的因素，如硫酸浓度、反应温度、搅拌转速和反应时间等进行了研究. 结果表明，当硫酸浓度为2.5 mol/L、反应温度为5oC、搅拌转速为900 r/min、反应时间为10 min时，可以得到短轴为800 nm左右、长径比为8~20、且短轴尺寸分布较窄的棒状硫酸沙丁胺醇微粒，产品收率为92.7%，纯度为98.5%. 经红外光谱、X射线衍射和紫外分光光度计分析测定证实，产物各项指标均符合中华人民共和国药典(2000年版二部)和英国药典(B. P., 1993)的要求.

关键词: 硫酸沙丁胺醇, 微细微粒, 反应结晶

Abstract: It is well known that ultra-fine salbutamol sulfate medicine particles have higher bioavailability than larger sized particles. A novel technology to synthesize ultra-fine particles of salbutamol sulfate was proposed. In the experiment, salbutamol and sulphuric acid were used as reactants and ethanol was used as the solvent. The effects of concentration of sulphuric acid, reaction temperature, stirring speed and reaction time on the preparation of salbutamol sulfate particles were investigated. The results showed that ultra-fine particles of salbutamol sulfate can be prepared and well-controlled under the following conditions: concentration of sulphuric acid 2.5 mol/L, reaction temperature 15oC, stirring speed 900 r/min and reaction time 10 min. The rod-like particles with mean diameter (short axis) of 800 nm, average aspect ratio of 8~20 and narrow size distribution were successfully obtained. The purity of the drug particles is higher than 98% and the yield is 92.7%. The crystal structure of particles was analyzed with IR, XRD and UV. The properties of salbutamol sulfate powders prepared meet the standard of Chinese Pharmacopoeia (2000) and B. P. (1993).

Key words: salbutamol sulfate, ultra-fine particles, reactive precipitation