盐酸氨溴索口腔崩解片的制备及质量评价  

Preparation and Quality Evaluation of Ambroxol Hydrochloride Orally Disintegrating Tablets

作　　者：奚炜[1] 杨柳[2] 张书银[1] 熊长友[1] 

机构地区：[1]湖北宜昌市第一人民医院,宜昌市443000 [2]湖北三峡大学护理学院,宜昌市443000

出　　处：《中国药房》2005年第18期1390-1391,共2页China Pharmacy

摘　　要：目的:制备盐酸氨溴索口腔崩解片并对其进行质量评价.方法:以甘露醇为主要辅料制备口腔崩解片,采用分光光度法测定氨溴索含量,并对崩解时限、口感、溶出度进行考查、测定.结果:最佳处方为微晶纤维素50g、甘露醇20g、羟丙基纤维素10g、碳酸氢钠2g;氨溴索检测浓度线性范围为0.005～0.030mg/ml(r=0.9 999),平均回收率为100.50%,平均RSD=0.71%;成品在30s内崩解完全.结论:该制剂具有快速崩解作用,并与市售片等效.OBJECTIVE： To prepare ambroxol hydrochloride orally disintegrating tablets and to evaluate its quality. METHODS： Mannitol was used as main adjuvant to prepare ambroxol hydrochloride orally disintegrating tablet, the UV spectrometry was adopted to determine ambroxol content, the disintegration time, taste and dissolution rate were evaluated. RESULTS： The optimal formulation was composed of MCC 50g, mannitol 20g, L-HPC 10g, and NaHCO3 2g; The detected concentration of ambroxol was linear in the range of 0.005～0.030mg/ml （r=0.9 999）, the average recovery was 100.50% and RSD = 0.71%; The prepared tablets disintegrated completely within 30s. CONCLUSION： The orally disintegrating tablets is quick to disintegrate and is as effective as market tablets.

关 键 词：盐酸氨溴索 口腔崩解片 制备 质量评价 

分 类 号：R974.1[医药卫生—药品] R927.2[医药卫生—药学]