硝苯地平原料药的粒度及粒度分布研究

摘要

Nifedipine is a kind of high permeability and low solubility of drugs. The solubility of nifedipine in vivo absorption effect is large, the size effect of nifedipine on the quality of products must be inspected. If the granularity of nifedipine between different batches is different, it may lead to the dissolution of inconsistent, which may result in inconsistent absorption, it will on the efficacy and safety have a direct impact. The method of light scattering was used to determine the size of the product. The method is simple, accurate and fast.%硝苯地平是临床常用的心血管系统药物，属于高渗透性，低溶解性药物，溶解性对体内吸收影响较大，需要考察其粒度对产品质量的影响。如果不同批次间粒度有差异，可能导致溶出的不一致，进而可能造成在体内吸收的不一致，对药效性及安全性都有直接的影响。因此，需要对其粒度及粒度分布进行控制，达到用药标准。为此，本研究参考有关资料，经过反复摸索，建立光散射法测定本品的粒度，该方法操作简便，准确快速。