Preparation and Quality Study of Mizolastine Sustained-release Tablet / 中国药房

ABSTRACT

OBJECTIVE:To prepare mizolastine sustained-release tablet and evaluate its quality.METHODS:The tablet was prepared with hydroxy propyl methylcellulose as controlled release agent,bitartaricum kalium as antacid and mizolastine as principal agent.The contents of mizolastine and the relative substances,the drug release rate in different medium(water,hydrochloric acid,and buffer phosphate),and the stability of the preparation were investigated(within 10 days).RESULTS:The preparation was well-formed in shape.the labeled content of the principal agent was 99.56%～102.39%;the content of the relative substances was less than 0.2%;its in vitro release rates in 3 different medium,were all above 80% after 2 h,and its stability was up to the standard.CONCLUSION:The prepared mizolastine sustained-release tablet is reasonable in formulation,feasible in preparation process and its quality is up to the standard.