摘要
为解决不透X线标志物供应不足的问题,研究制备一种高载药量硫酸钡包衣微丸作为不透X线标志物,探索其用于结肠传输功能检查,为慢传输型便秘的临床诊断及治疗提供参考依据。首先,采用挤出滚圆法制备硫酸钡微丸丸芯,通过粉末层积法在丸芯外包裹药物层,得到硫酸钡微丸。其次,结合流化床包衣技术制备硫酸钡包衣微丸,以体外稳定性、圆整度、收率等为指标,利用单因素试验和正交试验优化包衣处方和工艺参数。最后,通过透射电镜进行外观形态观察,并对硫酸钡包衣微丸的显影性和影响因素进行考察。结果表明,硫酸钡包衣微丸包衣液以3%乙基纤维素乙醇溶液为主要材料,包衣增重7.5%;所得的优化包衣参数为包衣液流速为6 Hz、雾化压力为3 MPa、进风温度为70℃、风机频率为30 Hz;制备的硫酸钡包衣微丸抗腐蚀性强,在酸碱中稳定,由内而外显影密度增强,显影效果清晰,在高温、高湿和光照条件下性质稳定。所研制的高载药量硫酸钡包衣微丸性质良好、处方合理、制备工艺稳定可行,可为临床提供一种新的成像清晰、质量稳定、价格低廉的不透X线标志物。
Aiming at the problem of inadequate supply of radioopaque markers,the preparation of high drug loading coated pellets of barium sulfate used as radioopaque markers for examining colonic transit function was explored,providing a reference for the clinical diagnosis and treatment of slow transit constipation.Firstly,extrusion-spheronization process was used to prepare the barium sulfate-loaded pellet cores,and the powder layering technique was applied to prepare the barium sulfate pellets.Then,the pellets were prepared by fluidized bed coating technology.The coating process and formulation parameters on the properties of the pellets were optimized by single factor test and orthogonal test based on the index of in vitro stability,roundness,and yield.Finally,transmission electron microscopy was used to observe the appearance,and the radiopacity and the influence factor experiment of high drug loading coated pellets of barium sulfate were investigated.The results show that the barium sulfate coated pellets are prepared with 3%EC ethanol solution as the coating solution,and coating weight increases by 7.5%.The obtained optimal coating process parameters are as follows:the flow rate of coating solution is 6 Hz,the atomization pressure is 3 MPa,the temperature of inlet air is 70℃,and the fan frequency is 30 Hz.Coated pellets of barium sulfate have high corrosion resistant property,and are stable in simulated gastrointestinal environment.The image density is gradually strengthened from inside to outside with satisfactory imaging,and coated pellets of barium sulfate are stable in the high temperature,high moisture and strong light conditions.The prepared high drug loading coated pellets of barium sulfate have good properties,the formulation is reasonable and the preparation method is stable.It can provide a new radioopaque marker with clear imaging,stable quality and low cost for clinical diagnosis.
作者
谢英花
马项项
孟晗川
何庆庆
马燕山
XIE Yinghua;MA Xiangxiang;MENG Hanchuan;HE Qingqing;MA Yanshan(School of Chemical and Pharmaceutical Engineering,Hebei University of Science and Technology,Shijiazhuang,Hebei 050018,China;Department of Radiology,Shijiazhuang Hospital of Traditional Chinese Medicine,Shijiazhuang,Hebei 050051,China)
出处
《河北科技大学学报》
CAS
北大核心
2022年第6期634-641,共8页
Journal of Hebei University of Science and Technology
基金
河北省自然科学基金-生物医药联合基金培育项目(H2021208003)。
关键词
药剂学
慢传输型便秘
结肠传输试验
不透X线标志物
影响因素实验
质量研究
pharmaceutics
slow transit constipation
colonic transit
radioopaque markers
influence factor experiment
quality research
