超微粉碎技术提高六味地黄丸(水蜜丸)溶出度的研究

Study on Improvement of Dissolution Rate of Water-honeyed Pills of Six Herbs with Rehmunnia by Technique of Super Fine Crushing

目的 :以丹皮酚为溶出指标 ,对不同粉碎技术制得的六味地黄丸进行溶出度测定 ,探讨粉碎工艺技术的影响。方法 :利用普通粉碎机、贝利微粉机制得药材细粉再制备水蜜丸 ,采用转蓝法和紫外分光光度法进行溶出度测定。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 :建议对六味地黄丸进行溶出度检查 ,同时在制剂工艺中采用超微粉碎来提高其溶出度。

Objective:To evaluate the affection of crushing technologyon on quality. The dissolution of Pills of Six Herbs with Rehmunnia prepared by different crushing technology was determined by taking the dissolution of Paeonol as test marker. Method: The Pills was prepared with the fine powder which was crushed by normal crusher or super fine crusher.The rotatory basket method was used, and the cumulative dissolution percentage was determined by UV. Result: Statistics indicated there was a significant difference in dissolution parameter (T 50 ) between super fine crushing powder Pills and normal fine crushing powder Pills ( P <0.01), and there was a difference in dissolution of different batches of Pills of Six Herbs with Rehmunnia prepared by the normal crush technique ( P <0.05).Conclusion:The determination of dissolution of Pills of Six Herbs with Rehmunnia is necessary. In order to improve the quality of drugs, we should adopt the technique of super fine crushing in the preparation procedure