复方新会陈皮含片的加速稳定性试验考察  

Accelerated stability test investigation of compound Xinhui pericarpium citri reticulatae buccal tablets

作　　者：张俊杰 梁志云[1] 昌水平[1] 张明[1] ZHANG Jun-jie;LIANG Zhi-yun;CHANG Shui-ping;ZHANG Ming(Pharmacy Department of Jiangmen Xin Hui Hospital of Traditional Chinese Medicine,Jiangmen City,Guangdong Province,529100,China)

机构地区：[1]广东省江门市新会区中医院药剂科,广东江门529100

出　　处：《蛇志》2020年第4期429-430,共2页Journal of Snake

摘　　要：目的考察复方新会陈皮含片制剂的稳定性。方法按《中国药典》2015版四部原料药物与制剂稳定性试验指导原则,进行加速稳定性试验,考察片剂性状、重量差异、药物鉴别、崩解时限、脆碎度、含量测定、微生物限度各指标变化情况。结果复方新会陈皮含片在温度(30±2)℃、相对湿度(65±5)%的恒温恒湿条件下,各指标基本无变化,均符合质量标准的规定。结论复方新会陈皮含片的质量稳定性良好。Objective To study the accelerated stability test of compound Xinhua pericarpium citri reticulatae buccal tablets.Methods According to the guiding principles of stability test of raw materials and preparations in Chinese Pharmacopoeia,2015 edition,Part 4.Conducting accelerated stability test,to investigating the changes of tablet characters,drug identification,disintegration time limit,brittleness,content determination and microbial limit.Results Compound Xinhui pericarpium citri reticulatae buccal tablets were tested for 6 months under the conditions of temperature(30±2)℃and relative humidity(65±5)%,all the test indexes were within the scope specified in the quality standard.Conclusion The quality stability of compound Xinhua pericarpium citri reticulatae buccal tablets was stable.

关 键 词：复方新会陈皮含片 加速试验 稳定性 

分 类 号：R28[医药卫生—中药学]