摘要
目的优化处方及考察制备、包衣工艺,确定适合工业生产的最佳处方。方法单因素法分别考察填充剂、崩解剂、黏合剂及包衣对氯沙坦钾片均匀分散时间的影响,在此基础上采用正交试验设计对其处方进行进一步优化,并对制备工艺进行试验筛选。结果氯沙坦钾片的处方组成为:填充剂为微晶纤维素、乳糖,崩解剂为5%低取代羟丙基纤维素,黏合剂为5%交联聚乙烯吡咯烷酮K30醇-水混合溶液,包衣液为15%欧巴代。结论制备的氯沙坦钾片,各项指标均符合规定,工艺稳定可靠。
Objective To optimize prescriptions,investigate preparation and coating technology,and to determine the best prescription for industrial production.Methods The single-factor method was adopted for investigating the effect of the filling agent,disintegrating agent and binding agent,and coating solution on the average dispersing time of losartan potassium tablets,followed by orthogonal experiments for further optimization.Results The prescription of losartan potassium tablets involved 5% L-HPC as the disintegrating agent,MCC and lactin as the filling agent,5%PVPK30 alcohol-water mixed solution as the binding agent,and 15%opadry as coating solution.Conclusion Each index of the prescription of losartan potassium tablets meet requirewents.The technology is stable and reliable.
出处
《解放军药学学报》
CAS
2012年第1期45-48,51,共5页
Pharmaceutical Journal of Chinese People's Liberation Army
关键词
氯沙坦钾
单因素法
正交试验
优化处方
losartan potassium
single-factor method
orthogonal experiment
optimized prescription
