以乳糖为辅料的苯磺酸氨氯地平片工艺优化

Technology Optimization of Amlodipine Besylate Tablets Using Lactose as Excipient

关键词:  苯磺酸氨氯地平片  乳糖  工艺优化  有关物质

Key words:  amlodipine besylate tablets  lactose  technology optimization  related substances

摘要:

目的 优化以乳糖为辅料的苯磺酸氨氯地平片生产工艺，以适应中国药典2015年版对苯磺酸氨氯地平片有关物质的控制要求。方法 采用正交试验法对粉末直接压片处方的工艺进行优化，并将优化后工艺与直接压片工艺产品同时进行加速试验，比较有关物质和溶出度。结果 优化工艺如下：将苯磺酸氨氯地平粉碎为100目，与微晶纤维素混合，以2% HPMC制粒并包裹颗粒，干燥，再与原处方中辅料混合，压片。经工艺优化的苯磺酸氨氯地平片，考察期内有关物质明显低于粉末直接压片工艺，溶出度符合中国药典2015年版规定。结论 该技术方案可为处方中含乳糖的苯磺酸氨氯地平片的制备提供一种新的思路。

Abstract:

OBJECTIVE To optimize the production technology of amlodipine besylate tablets using lactose as the excipient, and meet the requirements of Chinese pharmacopoeia 2015 edition for the control of the related substances in amlodipine besylate tablets. METHODS It was optimized that the technology of powder direct compression by orthogonal tests. At the same time, the accelerated test for the products about optimized and previous technology was carried out, in order to compare the related substances and dissolution in the products. RESULTS The optimum process was as follows: amlodipine besylate was milled to the particles through a 100-mesh screen, mixing the particles with microcrystalline cellulose, granulating and coating the granules with 2% HPMC, drying, mixing with other excipients in the original formulation, tableting. During the study period, the related substances in the amlodipine besylate tablets of optimized technology were significantly lower than that of the previous technology, and the dissolution was in accordance with the provisions of the Chinese Pharmacopoeia 2015 edition. CONCLUSION This new concept may be provided for the preparation of the amlodipine besylate tablets using lactose as excipient.