贝母丸与贝杏甘含片体外溶出行为的比较

Comparison of in vitro dissolution between Fritillaria Pill and Beixinggan Buccal Tablets

目的:通过比较贝母丸(贝母、苦杏仁、甘草)和贝杏甘含片(70乙醇贝母渗漉液、苦杏仁浸膏、甘草浸膏)体外溶出度来评价中药固体剂型的改进。方法:贝母素甲和贝母素乙作为贝母丸和贝杏甘含片的累积溶出百分率计算的对照品。结果:由试验结果得知,贝杏甘含片在60min内溶出量可达95,而贝母丸则需要180min。结论:应用测定溶出度方法可作为控制制剂质量以及制剂改进的依据。

AIM： To compare the dissolution in vitro between Beimu Pills （Bulbus fritillariae cirrhosae, Radix et Rhizoma glycyrrhizae, Semen armeniacae amarum） and Beixinggan Buccal Tablet （70% alcohol percolate of Bulbus fritillariae cirrhosae; extract of Radix et Rhizoma glycyrrhizae and extract of semen armeniacae amarum） to evaluate the reform of the traditional solid preparation. METHODS： Verticine and verticinone were adopted as the reference substance for the calculation of cumulative dissolution percentage. RESULTS： Cumulative dissolution reached 95% of dissolution rate, it took 60 min for Beixinggan Buccal Tablet and it took 180 min for Beimu Pills at the same condition. CONCLUSION： Dissolution method applied to the control over TCM preparation quality and to the reform of preparation can be recognized as one of the quality standard.