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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 prepare ambroxol hydrochloride dispersible tablets and determine the dissolution rate. Methods: Microcrystalline cellulose was used as filler, sodium carboxymethyl starch, low-substituted hydroxypropylcellulose and crospovidone as disintegrating agents, peppermint oil and aspartame as flavoring agents, hypromellose Su-E50 as a binder, magnesium stearate as a lubricant, silica gel as a flow aid, purified water as a wetting agent. The dissolution rate was determined by UV spectrophotometry. Results: The linear range of ambroxol hydrochloride dispersible tablets was 8 ~ 30μg · ml ~ (-1), the average recovery was 100.22% (RSD = 0.34%, n = 9) Greater than 99%. Conclusion: The preparation of the preparation process is reliable, the detection method is simple and accurate, suitable for the preparation and application of the hospital.