雷诺嗪缓释片的制备与研究

Ranolazine sustained-release tablets and Research

目的:雷诺嗪缓释片的制备方法与研究。方法:运用缓释技术制备雷诺嗪片,采用高效液相色谱法测定主药雷诺嗪的含量;高效液相法测定主药雷诺嗪的有关物质;并按《中华人民共和国药典》2005年版二部附录XD第一法依法测定其释放度。结果:制备的雷诺嗪缓释片含量测定平均为102.4%,RSD为0.76%;有关物质测定平均为0.3%,RSD为0.8%;本品每片在2小时、6小时和12小时的释放量应分别为标示量的20～40%、40～70%和80%以上,均应符合规定。结论:该制剂制备工艺可行,重现性好,适合大生产。

Objective ：ranolazine sustained-release tablets of preparation and research, enteric-coated capsule shell to avoid the stomach caused by accidental release brittle.Methods：Preparation of sustained-release technology and coating technology Ranolazine tablets by high performance liquid chromatography the content of the main drug ranolazine; HPLC with ranolazine main drug related substances; and press the ＂Republic of China Pharmacopoeia＂ ,2005 edition Appendix XD determined accordingto the release of the first law degree. Results： The of ranolazine sustained-release tablets prepared by an average determination of 100.5%, RSD 0.28%; related substances measured an average of 100.5%, RSD 0.28% ;Each of the product in 2 hours, 6 hours and 12 hours of release should be separately labeled amount of 20% to 40%, 40% to 70% and 80%, and shall comply with regulations. Conclusion ：The preparation process is feasible, reproducible, and suitable for mass production.