摘要
目的:制备盐酸氨溴索分散片并测定其溶出度。方法:选用微晶纤维素为填充剂,羧甲基淀粉钠、低取代羟丙纤维素、交联聚维酮为崩解剂,薄荷油与阿斯帕坦为矫味剂,羟丙甲纤维素-E50为粘合剂,硬脂酸镁为润滑剂,微粉硅胶为助流剂,纯化水为润湿剂。采用紫外分光光度法测定其溶出度。结果:盐酸氨溴索分散片含量测定的线性范围为8～30μg·ml^(-1),平均回收率为100.22%(RSD为0.34%,n=9);3批样品30 min溶出度均大于99%。结论:本制剂处方工艺可靠,检测方法简便、准确、适用于医院配制和应用。
Objective： To study the preparation technology and dissolution determination for ambroxal hydrochloride dispersible tablets. Method： Ambroxol hydrochloride dispersible tablets were prepared using microcrystalline cellulose as the diluent, sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose and crosspovidone as the disintegrants, peppermint oil and asipatan as the flavoring, hypromellose-E50 as the adhesive, magnesium stearate as the lubricant, aerosil as the glidant, and purified water as the mois- tening agent. The dissolution of the dispersible tablets was determined by UV spectropflotomery. Result： The detected concentration of ambroxol hydrochloride was linear within the range of 8-30μg·ml^-1. The average recovery was 100. 22% with RSD of 0. 34% （n =9）. The dissolution of 3 batches of samples was all above 99% in 30 min. Conclusion： The preparation technology is reliable, and the method is simple and accurate, which can be used in hospital production.
出处
《中国药师》
CAS
2011年第5期678-680,共3页
China Pharmacist
关键词
盐酸氨溴索
分散片
制备
溶出度
Ambroxol hyAroehloride
Dispersible tablets
Preparation
Dissolution
