| 引用本文: | 卢定强,常亚军,凌岫泉,贾静,党安旺.左旋氨氯地平溶析结晶工艺的研究[J].中国现代应用药学,2010,27(11):1006-1009. |
| .Study on Solventing-out Crystallization Process of Levoamlodipine[J].Chin J Mod Appl Pharm(中国现代应用药学),2010,27(11):1006-1009. |
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| 摘要: |
| 目的 研究利用溶析结晶法提纯左旋氨氯地平的工艺。方法 采用差重法测定正庚烷-二氯甲烷混合溶剂的溶解度，研究了左旋氨氯地平溶析结晶的温度、反溶剂的含量及导入方式、搅拌转速对左旋氨氯地平的纯度和收率的影响。结果 左旋氨氯地平在正庚烷-二氯甲烷溶液中的溶解度随着正庚烷浓度的升高而减小，确定了最佳结晶条件为温度：25 ℃；正庚烷/二氯甲烷质量比为1.5~1.75；搅拌速度：300 r·min-1。结论 该结晶工艺得到的产品纯度和收率较高，其工艺具有操作简易、易于工业化等特点，同时也为氨氯地平单一对映体制备成各种剂型开辟良好的前景。 |
| 关键词: 左旋氨氯地平 溶析结晶 纯度 收率 |
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| Study on Solventing-out Crystallization Process of Levoamlodipine |
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LU Dingqiang1 2 CHANG Yajun1 LING Xiuquan1 JIA Jing1 DANG Anwang1
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| Abstract: |
| OBJECTIVE To study the solventing-out crystallization process of levoamlodipine. METHODS The gravimetric method was used to measure the solubility of levoamlodipine in the mixture of n-heptane and dichloromethane. It is studied the effect factors on the purity and the yield of levoamlodipine crystallization which included the temperature, the quantity of anti-solvent, the flow rate of n-heptane introduced into levoamlodipine dichloromethane solution and the rotary speed. RESULTS The solubility of levoamlodipine in the mixture increased remarkably during the reduction of the n-heptane’s ratio at the fixed temperatures. The optimized condition was temperatures: 25 ℃; the mass ratio of n-heptane to dichloromethane: 1.5-1.75; rate of rotation: 300 r·min-1. CONCLUSION The product obtained from the crystallization process has the higher purity and yield. The technology has the advantages such as simple operation, easy-to-industrialization and so on. What is more, it is opening up good prospects for preparation of the single amlodipine enantiomer of a variety of formulation. |
| Key words: levoamlodipine solventing-out crystallization purity yield |
