盐酸氨溴索口腔崩解片的制备及质量评价

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=0.9999),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。

Preparation and Quality Evaluation of Ambroxol Hydrochloride Orally Disintegrating Tablets

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 spec-trometry 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.