基于光学显微及电镜分析技术的土霉素片溶出行为解析  

Study on the dissolution behavior of oxytetracycline tablets based on optical and electron microscope analysis

作　　者：张少萌 张冬 杨天风 丁维靖 ZHANG Shaomeng;ZHANG Dong;YANG Tianfeng(Hebei Drug Evaluation Center,Hebei,Shijiazhuang 050090,China)

机构地区：[1]河北省药品审评中心,石家庄市050090 [2]河北省药品医疗器械检验研究院 [3]河北省儿童医院

出　　处：《河北医药》2024年第13期2055-2060,共6页Hebei Medical Journal

摘　　要：目的 建立土霉素片溶出度测定方法,考察不同企业产品体外溶出行为的差异;利用光学显微、电镜分析技术追溯引发溶出行为差异的根本原因。方法 采用桨法-HPLC法测定溶出度,采用光学显微及电镜分析技术对片芯中土霉素与辅料形态与溶出行为进行分析。结果 土霉素在18.5~92.6μg/mL浓度范围内线性关系良好,平均回收率为98.4%,RSD为0.7%(n=9),方法准确可靠。偏光显微镜法和扫描电镜法的分析结果显示制剂中原、辅料的晶体形态与存在状态与药物的溶出行为存在一定的相关性。结论 对于多晶型药物,利用光学显微及电镜分析与溶出度相结合的方法可更有效、全面地评价其口服固体制剂的质量。Objective To establish a method for determining the dissolution of oxytetracycline tablets in evaluating differences of in vitro dissolution behavior of products from different enterprises.The root cause of the difference in dissolution behavior was traced by optical microscopy and electron microscopy technology.Methods The dissolution rate was determined by paddle method or high-performance liquid chromatography(HPLC)method.The morphology and dissolution behavior of oxytetracycline and excipients in the tablet core were analyzed by optical and electron microscopy.Results The linear relationship of oxytetracycline was good in the concentration range from 18.5 to 92.6μg/mL,with the average recovery of 98.4%,relative standard deviation(RSD)of 0.7%(n=9),and the method was accurate and reliable.The results of polarizing microscopy and scanning electron microscopy showed that the crystal morphology and existence state of the raw materials and excipients were related to the dissolution behavior of oxytetracycline.Conclusion For polymorphic polycrystalline drugs,the quality of oral solid preparations can be evaluated more effectively and comprehensively by the combination of optical microscopy and electron microscopy analysis.

关 键 词：土霉素片 溶出行为 光学显微 电镜分析 药物评价 

分 类 号：R944.4[医药卫生—药剂学]