摘要
目的:筛选盐酸埃他卡林(iptakalim hydrochloride)片的处方及优化工艺,对本片进行质量研究。方法:处方及工艺研究采用比较法,含量、含量均匀度及溶出度测定为溶剂萃取酸性色素比色法(BCG法),有关物质检查采用HPLC法(示差折光检测器)。结果:所选处方合理、工艺可行;BCG法灵敏、可靠、重复性好、操作简单,能够很好地控制本片的质量。结论:按照该处方及工艺压制的盐酸埃他卡林片具有良好的稳定性;制定了本片的制剂质量标准,为新药报批提供了制剂研究资料。
Objective：To screen formulations, optimize preparing process and study the quality control of iptakalim hydrochloride tablets. Methods：The comparison method was used in formulation and process study. The solvent extraction acidic pigment color method （the BCG method） was used in content determination, content uniformity and dissolution. A HPLC method was applied in related substances assay. Results：A reasonable formulation and feasible preparation were developed. The BCG method established was sensitive, reliable and simple with good reproducibility. The quality of iptakalim hydrochloride tablets was controlled very well. Conclusion：Iptakalim hydrochloride tablets prepared with the optimized formulation and process demonstrated good stability. This study formulated the quality standard and offered preparation study for the new preparation registration.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2007年第20期1702-1704,共3页
Chinese Journal of New Drugs
基金
国家1035工程重点项目(969010101)
关键词
盐酸埃他卡林片
处方
工艺
含量测定
iptakalim hydrochloride tablets
formulation
technique
content determination
