汉防已甲素壳聚糖微球的制备和质量研究

Preparation and Characteristics of Tetrandrine Chitosan Microspheres

目的对汉防己甲素壳聚糖微球的制备工艺和制得的微球的质量进行研究。方法以壳聚糖为载体，采用乳化交联法制备汉防己甲素壳聚糖微球。在单因素考察的基础上，利用正交试验设计优化汉防己甲素壳聚糖微球制备工艺，并对制得微球的粒径，形态，工艺重复性，稳定性，体外突释情况等进行研究。结果制得的微球的形态圆整，微球的平均粒径为（9．73±1．34）μm，粒径在9—12μm的占总数的85％以上，载药量为（32．21±3．21）％，包封率为（40．33±5．32）％，最佳工艺条件重复性良好。结论筛选的最佳处方工艺可制备性质优良的微球。

OBJECTIVE To prepare tetrandrine christon microspheres, and evaluate its characteristics. METHODS The microspheres were prepared by emulsion chemical cross-linking method using chitosan as wall material. Based on the result of single-factor selecting experiment, the preparation methods were evaluated by orthogonal experiment method. The mean diameter and the size distribution of microspheres, the drug loading, the envelop efficiency ; the reproducibility of pharmaceutical technology and the stability of optimized microspheres were examined. RESULTS The tetrandrine chitosan microspheres were regular in their morphology. The average particle size of microspheres was （9.73 ± 1.34）μm, with over 85 % of the microspheres being in the range of 9 - 12 μm; The drug loading and their envelop efficiency were （32.21 ± 3.21 ）% and （40.33 ± 5.32 ）% , respectively. The reproducibility and stability of pharmaceutical technology was good. CONCLUSION The optimized preparation could prepare good qualities of tetrandrine christon microspheres.