处方中的辅料对瑞舒伐他汀钙片溶出的影响  

Effect of inactive ingredient on the dissolution of rosuvastatin calcium tablets

作　　者：何华 宋丽洁 吴青青 陈佩佩 潘玉婷 赵旺明 HE Hua;SONG Li-jie;WU Qing-qing;CHEN Pei-pei;PAN Yu-ting;ZHAO Wang-ming(Drug Research Institute of Yangtze River Pharmaceutical Group Co.,Ltd.,Jiangsu Taizhou 225321,China)

机构地区：[1]扬子江药业集团有限公司药物研究院,江苏泰州225321

出　　处：《中国医院药学杂志》2022年第14期1437-1441,1446,共6页Chinese Journal of Hospital Pharmacy

摘　　要：目的:通过对比溶出曲线,研究处方中的辅料对瑞舒伐他汀钙片溶出的影响。方法:采用粉末直接压片工艺,通过单因素试验,考察处方中乳糖的型号、微晶纤维素的来源、钙盐的种类、交联聚维酮的型号及用量、硬脂酸镁的用量和包衣粉的用量对瑞舒伐他汀钙片溶出的影响。结果:不同的乳糖型号(T80、PW80、315)、微晶纤维素来源(PH102、M102、102)、硬脂酸镁用量(0.5%、1%、2%)、包衣粉用量(2%、3%、4%)对溶出的影响差异较小,钙盐的种类(磷酸钙、无水磷酸氢钙、碳酸钙)、交联聚维酮的型号(XL、XL-10)及用量(3%、5%)对溶出的影响有一定差异。结论:处方中的稳定剂及崩解剂对瑞舒伐他汀钙片的溶出有影响,填充剂、润滑剂及包衣粉对溶出影响较小。OBJECTIVE To study the effect of inactive ingredient on the dissolution of rosuvastatin calcium tablets by comparing the dissolution curves.METHODS By powder direct compression technology,with single-factor experiments,the influence of the types of lactose,the sources of microcrystalline cellulose,the types of calcium salt,the types and dosages of crospovidone,the dosages of magnesium stearate and coating powder on the dissolution of rosuvastatin calcium tablets was studied.RESULTS The different types of lactose(T80,PW80,315),sources of microcrystalline cellulose(PH102,M102,102),dosages of magnesium stearate(0.5%,1%,2%) and coating powder(2%,3%,4%) had little effect on the dissolution.The types of calcium salt(calcium phosphate,anhydrous calcium hydrogen phosphate,calcium carbonate),types of crospovidone(XL,XL-10) and dosages(3%,5%) had some difference on the dissolution.CONCLUSION The stabilizers and disintegrating agents in the formulation had influence on the dissolution of rosuvastatin calcium tablets,while the fillers,lubricants and coating powder had little influence on the dissolution.

关 键 词：辅料 瑞舒伐他汀钙片 溶出 直接压片 

分 类 号：R944[医药卫生—药剂学]