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目的 :以葛根素为溶出指标 ,对不同粉碎技术制得的愈风宁心片进行溶出度测定 ,探讨粉碎工艺技术对其质量影响。方法 :利用普通粉碎机、超微粉碎机制得葛根药材再制备片剂 ,采用转蓝法和高效液相色谱法进行测定。结果 :不同粉碎技术制得的制剂间溶出度差异极显著 (P <0 .0 1) ;普通粉碎工艺技术制得的制剂 ,不同批次间溶出度差异显著 (P <0 .0 5 )。结论 :建议对愈风宁心片进行溶出度检查 ,同时在制剂工艺中应采用细胞级粉碎技术粉碎生药来提高产品质量
Objective : To determine the dissolution of Yufeng Ningxin Tablets produced by different comminution techniques with puerarin as the dissolution index, and to discuss the impact of comminution technology on its quality. Methods : Pueraria lobata medicinal materials were prepared by ordinary pulverizer and ultrafine pulverization mechanism and then tablets were prepared. The method was determined by the transfer blue method and high performance liquid chromatography. RESULTS: There was a significant difference in dissolution rate among the preparations prepared by different comminution techniques (P < 0.01), and there was a significant difference in the dissolution of the preparations obtained by ordinary comminution technology (P <0. 05). Conclusion: It is recommended that the dissolution test of Yufengningxin Tablets should be conducted. At the same time, cell-level crushing technology should be used to crush the crude drug in the preparation process to improve the product quality.