摘要
目的制备氢溴酸高乌甲素分散片,考察辅料对其崩解时限、混悬液稳定性的影响。方法以可压成型性和崩解时限为指标进行单因素考察,以选择适宜的填充剂、崩解剂和润滑剂及其用量,以及适宜的压力;以崩解时限及混悬液稳定性为指标从正交实验设计中确定最佳处方,并与普通片剂进行体外溶出比较。结果所选处方工艺制得分散片,外观光洁,在15 s内完全崩解,并通过内径为710μm的筛。分散片溶出速度远快于普通片剂。结论辅料的选择和用量,对于氢溴酸高乌甲素分散片的性质有明显影响,混悬液稳定性受原药、辅料粒度的影响较大。
Objective To prepare lappaconitine Hydrobromide dispersible tablets, investigate additions that affected disintegration time and suspensibility. Methods Single factor investigation was performed to choose suitable kinds and amount of filler, disinter grants, lubricants and proper press by using disintegration time and compressibility as indices. The best formulation was optimized by using orthogonal design which took the disintegration time and the suspensibility as indices. The in vitro dissolution rate of the dispersible tablets was compared with the common tablets. Results The tablets prepared were fine in appearance, disinte- grated within 15s, the suspension screened through the 710μm mesh. The dissolution rate of the dispersible tablets is more rapidly than common tablets. Conclusion The quality of the dispersible tablets is mostly related to the kind and the amount of the additions. The stability of the suspension is affected greatly by the powder size of lappaconitine Hydrobromide and additions.
出处
《时珍国医国药》
CAS
CSCD
北大核心
2008年第5期1197-1199,共3页
Lishizhen Medicine and Materia Medica Research
关键词
氢溴酸高乌甲素
分散片
崩解时限
Lappaconitine hydrobromide
Dispersible tablets
Disintegration time
