市售盐酸氟桂利嗪胶囊剂质量评价

Quality evaluation of different flunarizine preparations

目的 对市售四厂家的盐酸氟桂利嗪胶囊剂进行质量评价。方法 就外观、含量、溶出、杂质、均匀度和包装密封性等方面进行分析比较。结果 各厂家产品溶出度均在药典要求范围内。以高效液相色谱法测定含量 ,A ,B和C厂家的产品在标示量的± 10 %范围内 ;含量均匀度A和B符合药典要求 ;A厂家和B2 ,B3产品的杂质总量小于 1.5 % ,B1,C ,D的杂质总量在 1.5 6 %～ 10 .96 %间。水泡眼包装密封性仅B厂家略有问题。

OBJECTIVE: To evaluate the qualities of flunarizine capsules from four manufacturers. METHOD: The contents of flunarizine in the preparations were determined by HPLC. The package and appearance, dissolution, uniformity and related substances were also examined. RESULTS: The 9/12 flunarizine products were above 90% of the labeled content. The dissolution and fill-mass content complied with the general criteria of the 2000ed Chinese Pharmacopoeia. The total related substances of the product A, B, C and D were less than 0.79%, 1.82% 2.04% and 10.96%, respectively. CONCLUSION: The quality of the product A was found to be better here.