Preparation and Quality Evaluation of Ambroxol Hydrochloride Orally Disintegrating Tablets / 中国药房

ABSTRACT

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.