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Preparation of Sustained-release Silybin Microspheres by Spherical Crystallization Technique

球晶制粒技术制备水飞蓟宾缓释微球(英文)

作     者:胡容峰 朱家壁 马凤余 许向阳 孙玉亮 梅康康 李 师 HU Rong-feng;ZHU Jia-bi;MA Feng-yu;XU Xiang-yang;SUN Yu-liang;MEI Kang-kang;LI Shi

作者机构:中国药科大学药剂研究所江苏南京210009 安徽中医学院药剂教研室安徽合肥230038 

出 版 物:《Journal of Chinese Pharmaceutical Sciences》 (中国药学(英文版))

年 卷 期:2006年第15卷第2期

页      面:83-91页

学科分类:1008[医学-中药学(可授医学、理学学位)] 10[医学] 

主  题:silybin sustained-release microsphere solid dispersion spherical crystallization technique 

摘      要:Aim To improve the dissolution rate and bioavailability of silybin. Methods Sustained-release silybin microspheres were prepared by the spherical crystallization technique with soliddispersing and release-retarding polymers. A differential scanning calorimeter and an X-ray diffractometer were used to investigate the dispersion state of silybin in the microspheres. The shape, surface morphology, and internal structure of the microspheres were observed using a scanning electron microscope. Characterization of the microspheres, such as average diameter, size distribution and bulk density of the microspheres was investigated. Results The particle size of the microspheres was determined mainly by the agitation speed. The dissolution rate of silybin from microspheres was enhanced by increasing the amount of the dispersing agents, and sustained by the retarding agents. The release rate of microspheres was controlled by adjusting the combination ratio of the dispersing agents to the retarding agents. The resuits of X-ray diffraction and differential scanning calorimetry analysis indicated that silybin was highly dispersed in the microspheres in amorphous state. The release profiles and content did not change after a three-month accelerated stability test at 40 ℃ and 75% relative humidity. Conclusion Sustained-release silybin microspheres with a solid dispersion structure were prepared successfully in one step by a spherical crystallization technique combined with solid dispersion technique. The preparation process is simple, reproducible and inexpensive. The method is efficient for designing sustained-release microspheres with water-insoluble drugs.

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