超微粉碎技术在枳术丸中的应用及其溶出影响研究

The Application of the Micronization Technology in Zhizhu-Pills and the Produced Impact of its Dissolution

目的:对经微粉化制备的枳术丸与枳术丸进行显微、理化鉴别、溶出情况对比研究,探索超微粉碎对丸剂质量的影响。方法:采用TLC法鉴别枳实与白术、采用HPLC法测定枳术丸橙皮苷的体外溶出情况,并采用了Weibull分布模型进行溶出动力学模拟。结果:超微粉碎与普通粉碎后TLC无显著差别,经微粉化制备的枳术丸各时间点的有效成分溶出较普通丸剂快。结论:枳术丸经超微粉碎后橙皮苷溶出量增加,溶出速度明显提高。

Objective： To search for the micronization impact to the pill preparation, we carry out a series of comparative study on the micro characteristic,TLC characteristic,dissolution results of Ultro-micro and Normal powder of Zhizhu pill. Method： Using Fructus Aurantii Immaturus and Rhizoma Atractylodis Macrocephalae, the TLC information can be identified. Taking Hesperidin as the index component, the dissolution character were compared. The Weibull distribution analysis system were also applied. Result：We can see the almost similar TLC characteristic in the two pills, however the significant differences can be identified in the dissolution study on the Uhro-micro and the normal pills. Obviously, the dissolution rate and the total quantity of Hesperidin in the ultro-micro pills were increaseed. Conclusion： The active component of the pills can not be destructed in the process of micronization. Moreover, this behavior truly increase the vitro-utilization of the preparation.