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2015, v.25(02) 86-89+95

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超临界CO_2抗溶剂法制备谷维素/PVP-K30固体分散体
Preparation of Oryzanol/PVP-K30 Solid Dipersions by Supercritical CO_2 Anti-Solvent Technology

朱甜,缪虹刚,林文,王志祥,黄德春,颜庭轩
ZHU Tian,MIAO Honggang,LIN Wen,WANG Zhixiang,HUANG Dechun,YAN Tingxuan

摘要(Abstract):

目的制备谷维素/PVP-K30固体分散体,提高谷维素的体外溶出度。方法采用超临界CO2抗溶剂法,以回收率为主要评价指标,在单因素试验的基础上设计正交试验优选制备谷维素/PVP-K30固体分散体的工艺,对最优工艺下得到的复合物进行红外光谱(IR)及扫描电镜(SEM)的表征,并测定其体外溶出度。结果制备谷维素/PVP-K30的最优工艺为:谷维素质量浓度14 mg/m L,结晶压力14 MPa,结晶温度55℃,溶液体积流量0.9 m L/min。此条件下产品平均回收率为88.22%,IR和SEM表明固体分散体中谷维素可能与PVP-K30发生氢键作用并以无定型形式存在,体外溶出度实验表明谷维素/PVP-K30固体分散体能显著提高谷维素的体外溶出度。结论超临界CO2抗溶剂法制备维素/PVP-K30固体分散体工艺可行,谷维素溶出度显著提高。
OBJECTIVE To improve the in vitro dissolution rate of oryzanol,oryzanol / PVP-K30 solid dispersions were prepared.METHODS With recovery rate and drug-loading rate as the main evaluation indexs,on the basis of single factor experiments,orthogonal experimental design was used to optimize the preparation process of oryzanol / PVP-K30 solid dispersions by supercritical CO2anti-solvent technology. The experiments such as DSC,IR,SEM and in vitro dissolution were used to analyze the optimal process combination. RESULTS The orthogonal experimental optimization process conditions were set as follows: mass concentration of oryzanol 14 mg / m L,crystallization pressure 14 MPa,crystallization temperature 55 ℃,solvent flow rate 0. 9 m L / min. Under the optimal conditions,the average recovery rate of the solid dispersion was 88. 22%,IR and DSC analysis showed that oryzanol in the solid dispersion was amorphous form,and hydrogen bond may have been formed between oryzanol and PVP-K30. The experiments of in vitro dissolution showed that the dissoluion rate of oryzanol / PVP-K30 solid dispersions was significantly increased. CONCLUSION Supercritical CO2anti-solvent technology is feasible to prepare oryzanol / PVP-K30 solid dispersions.

关键词(KeyWords): 超临界CO2抗溶剂法;谷维素;固体分散体;溶出度
supercritical CO2anti-solvent technology;oryzanol;solid dispersion;dissoluion rate

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基金项目(Foundation): 江苏省自然科学基金资助项目(BK2012763)

作者(Author): 朱甜,缪虹刚,林文,王志祥,黄德春,颜庭轩
ZHU Tian,MIAO Honggang,LIN Wen,WANG Zhixiang,HUANG Dechun,YAN Tingxuan

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