射银咽炎颗粒的制备工艺和含量测定  

Preparation Process and Content Determination of Sheyin Pharyngitis Granules

作　　者：梁健 吴轶 刘丹政 许龙[3] 沈熊 LIANG Jian;WU Yi;LIU Danzheng;XU Long;SHEN Xiong(Dept.of Pharmacy,Zhongshan Hospital,Fudan University,Shanghai 200032;Dept.of Otolaryngology,Zhongshan Hospital,Fudan University,Shanghai 200032;Hefei Innovation Pharmaceutical Technology Co.,Ltd.,Hefei 230088)

机构地区：[1]复旦大学附属中山医院药剂科,上海200032 [2]复旦大学附属中山医院耳鼻喉科,上海200032 [3]合肥创新医药技术有限公司,安徽合肥230088

出　　处：《中国医药工业杂志》2023年第11期1601-1606,共6页Chinese Journal of Pharmaceuticals

基　　金：上海市临床重点专科建设项目(shslczdzk06504)。

摘　　要：该研究采用流化床法制备射银咽炎颗粒,以流化床雾化压力、流化温度和喷液速率为考察指标,颗粒合格率(即粒径180~2000μm颗粒占总量的比例)和溶化时间为评价指标,采用Box-Behnken设计优化工艺参数,并采用高效液相色谱-二极管阵列检测(HPLC-DAD)法测定颗粒剂中绿原酸、哈巴苷、哈巴俄苷、次野鸢尾黄素的含量。结果显示,优化条件为雾化压力22 kPa,进风温度66℃,喷液速率1.55 mL/min,所得颗粒的合格率和溶化时间分别为91.51%和42.87 s。颗粒剂中绿原酸、哈巴苷、哈巴俄苷、次野鸢尾黄素的含量分别为3.22、0.72、0.63和0.16 mg/g。The study utilized a fluidized bed method to prepare Sheyin pharyngitis granules.The Box-Behnken design was used to optimize the process parameters,with the fluidized bed atomization pressure,fluidization temperature,and spray liquid rate as the investigation indicators,and the qualification rate(namely the proportion of the granules with the particle size of 180-2000μm to total granules)and dissolution time as the evaluation indicators.Additionally,the high-performance liquid chromatography method coupled with a diode array detector(HPLC-DAD)was established to determine contents of chlorogenic acid,harpagide,harpagoside and irisflorentin in the granules.The results indicated that the optimized process parameters were as follows:an atomization pressure of 22 kPa,an inlet air temperature of 66℃,and a spray liquid rate of 1.55 mL/min.The qualification rate and dissolution time of the obtained granules were 91.51%and 42.87 s,respectively.The contents of chlorogenic acid,harpagide,harpagoside and irisflorentin in the granules were 3.22,0.72,0.63 and 0.16 mg/g,respectively.

关 键 词：射银咽炎颗粒 流化床 BOX-BEHNKEN设计 绿原酸 哈巴苷 哈巴俄苷 次野鸢尾黄素 

分 类 号：R944.27[医药卫生—药剂学]