目的：制备复方布洛肾素那敏片，并对所制备的样品与原研市售品进行释放度一致性研究，确保自制品与原研市售品释放度相似。方法采用湿法制粒和流化床干燥制备复方布洛肾素那敏片；采用高效液相色谱法进行体外释放度的检测。结果自制品在四种溶出介质中与原研市售品进行溶出曲线比对，其f2值都﹥50。结论本制剂制备工艺操作简便，释放度相似更能保证自制品与市售品的质量一致性。%Objective To prepare Allergy and Congestion Relief and compare the original commercial product Advil and as-prepared products with consistency of release rate. At the same time to ensure that the as-prepared products are consistent with release rate of Advil. Methods Allergy and Congestion Relief was prepared by the wet granulation,drying by fluidized bed and detecting the release rate by HPLC. Results Compared the as-prepared products of dissolution curve to Advil in four dissolution medias,the date of f2 ﹥50. Conclusion The preparation process was simple,and the similar re-lease rate can ensure consistency in the quality of self-made products and Advil.
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