恩诺沙星肠溶微粒包衣工艺研究

enrofloxacin particles

关键词:  恩诺沙星  肠溶包衣 微料  方法学 正交试验

Key words:  Enrofloxacin  Enteric coating  Particles Methodology  Orthogonal experiment

摘要:

目地：研究恩诺沙星微料肠溶包衣的制备工艺,并对其进行质量评价。方法：采用紫外分光光度法测定肠溶微料在释放介质中恩诺沙星含量；以酸中药物释放量为指标,以枪压、包衣速度、进风温度为因素,采用L9(34)正交试验确定恩诺沙星微料肠溶包衣的最佳工艺。结果：以0.1mol/L盐酸溶液为溶剂,恩诺沙星在2.0μg/ml～8.0μg/ml范围内线性良好,样品平均加样回收率99.88%,日间RSD=0.33%,日内平均RSD=0.47%,3小时测定吸收度几乎没变化。设定枪压0.24MPa,包衣速度60ml/min,进风温度50℃进行肠溶包衣制作的微料剂各项指标符合要求。结论：本研究建立的恩诺沙星含量测定方法,操作简单,结果可靠,符合要求；通过正交试验,能够获得恩诺沙星肠溶包衣制备最佳工艺流程。

Abstract:

Objective: To investigate the Preparation process of enteric coating enrofloxacin particles and quality evaluation of them.Methods: This research uses the ultraviolet spectrophotometric method to determine enrofloxacin content. Take the factors like Flow tate of jetting,Inlet air temperature and gun pressure into consideration, the optimized formula of the enteric coating enrofloxacion particles was determined by L9(34) orthogonal test design. Results:With the 0.1mol/L hydrochloric acid as the resolver,the density of2.0μg/ml～8.0μg/ml ,the extinction value and the density assume and the linear relationship.The average recovery rate is 99.90% and daytime deviation RSD=0.33%,The average days of deviation RSD=0.47%,Within 3 hours, there is almost nothing changed in absorption. Flow tate of jetting was 60ml/min,Inlet air temperature was 50℃ and the gun pressure was0.24MPa.such enteric-coated granules prepared by bottom spray coating method are in line with the quality requirements. Conclusion:This method is simple in operation,and the result is reliable. The optimized technology of preparing film coating in enteric coating enrofloxacin particles Can be obtained by orthogonal experiment.