复方地氯咽炎喷雾剂的制备与质量评价

Preparation and Quality Evaluation of Compound Dexamethasone and Chlorhexidine Pharyngitis Spray

目的制备复方地氯咽炎喷雾剂并评价其质量。方法以地塞米松磷酸钠和醋酸氯己定为主药,蒸馏水为主要溶剂制备喷雾剂。采用高效液相色谱法测定主药含量。按照2010年版《中国药典》对喷雾剂的要求和方法对制剂进行检测。结果所制喷雾剂为无色透明液体,每瓶总喷次、每喷量、每喷主药含量等均符合规定。地塞米松磷酸钠质量浓度在10～200μg/mL范围内与峰面积线性关系良好(r=0.9995),平均回收率100.30%,RSD=1.76%(n=6);醋酸氯己定质量浓度在10～200μg/mL范围内与峰面积线性关系良好(r=0.9996),平均回收率98.53%,RSD=3.26%(n=6)。结论该制剂制备工艺简单可行,含量测定方法简便可靠,有望开发成治疗急慢性咽炎的新制剂。

Objective To prepare the compound pharyngitis spray of dexamethasone and chlorhexidine,then establish its quality control method.Methods The compound pharyngitis spray was prepared using dexamethasone sodium phosphate and chlorhexidine acetate as principal agents and distilled water as primary solvent.The test was conducted according to China Pharmacopoeia in 2010 edition of the spray of the requirements and methods.The content of dexamethasone sodium phosphate and chlorhexidine acetate was determined by HPLC.Results The compound pharyngitis spray was colorless clearing solution.The total spray bottle,each spray volume and the uniformity of delivered dose was all according to relative regulate.The dexamethasone concentration was linear within the range of 10-200 μg/mL（r=0.999 5）,the average recovery rate was 100.30%,RSD was 1.76%（n=6）;the chlorhexidine acetate concentration was linear within the range of 10-200 μg/mL（r=0.999 6）,the average recovery rate was 98.53%,RSD was 3.26%（n=6）.Conclusion The preparation technology is simple,feasible and reproducible.The determination method is simple and reliable.It is expected to be a new preparation for the treatment of acute and chronic pharyngitis.