氨氯地平分散片的产业化研究

Study on Industrialization of Amlodipine Dispersible Tablets

由于氨氯地平在水中溶解度为微溶,极大程度地影响了其溶出效果,降低了生物利用度。本文将原料以微粉化的方式提高了氨氯地平的生物利用度,并以粉末直压的生产工艺直接制成氨氯地平分散片。并以性状、溶出度、有关物质、含量等一些列的关键质量参数对其进行了稳定性考察,稳定性存放的测试结果完全符合中国药典的要求。并按要求开展与原研品进行质量一致性评价,评价结果为相似。

The solubility of amlodipine in water is slightly soluble,which greatly affects its dissolution effect and reduces its bioavailability.In this paper,the bioavailability of amlodipine was improved in the form of ultrafine powder,and amlodipine dispersible tablets were directly prepared by the production process of powder direct compression.The stability was investigated by analyzing some key quality parameters,such as character,dissolution,related substances,content and so on.The test results of stable storage completely met the requirements of Chinese Pharmacopoeia.According to the requirements,the quality consistency evaluation with the original research products was carried out,and the evaluation results were similar.