毕微,闫中天,刘晓红,黄竹青,何仲贵
BI Wei1,YAN Zhong-tian1,LIU Xiao-hong1,HUANG Zhu-qing2,HE Zhong-gui1(1.School of Pharmacy

• 1:沈阳药科大学药学院
• 2:辽宁中医药大学职业技术学院

摘要(Abstract)：

目的提高维生素D3在制剂中的稳定性与体外溶出度。方法采用冷冻干燥法制备维生素D3-羟丙基-β-环糊精包合物;通过差示扫描量热法验证包合物的形成;采用加热和光照实验考察包合物的稳定性;采用《中华人民共和国药典》溶出度测定法考察包合物的体外溶出度。结果与维生素D3相比,维生素D3-羟丙基-β-环糊精包合物对光、热的稳定性显著提高,在高温或强光条件下存放10 d,包合物中维生素D3的含量下降均在6%以内;体外溶出度在60 min内达到97%以上,是包合前的5倍。结论维生素D3经羟丙基-β-环糊精包合后能显著提高稳定性和体外溶出度。
Objective To prepare the vitamin D3-hydroxypropyl-β-cyclodextrin complex and determine its stability and dissolution characteristics.Methods The inclusion complex of vitamin D3-hydroxypropyl-β-cyclodextrin was prepared by freeze-drying way.The differential scanning calorimetric method was used for identification of the complex.Results Vitamin D3 entirely decomposed at 60 ℃,40 ℃ and(4 500±500)lx within 10 d,while its complex with hydroxypropyl-β-cyclodextrin still retained more than 97% of the original content.The dissolution rate of vitamin D3 increased as 5 times as that of pure drug.Conclusions The vitamin D3-hydroxypropyl-β-cyclodextrin complex can significantly improve the stability and dissolution rate of vitamin D3.

关键词(KeyWords)： 维生素D3;羟丙基-β-环糊精;冷冻干燥;稳定性;溶出度
vitamin D3;hydroxypropyl-β-cyclodextrin;lyophilization;stability;dissolution

Abstract:

Keywords:

基金项目(Foundation): 国家九五科技攻关项目(96-902-02-09)

作者(Author): 毕微,闫中天,刘晓红,黄竹青,何仲贵
BI Wei1,YAN Zhong-tian1,LIU Xiao-hong1,HUANG Zhu-qing2,HE Zhong-gui1(1.School of Pharmacy

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