黄芪注射液浓缩液微乳的制备及其体外释放实验评价研究

目的:制备黄芪注射液浓缩液微乳,并对其质量及体外释放进行评价。方法:采用伪三元相图法,结合稳定性考察,优选处方;采用HPLC法测定黄芪注射液浓缩液微乳中黄芪甲苷的含量;采用紫外分光光度法测定黄芪总皂苷的含量,并对微乳的类型、载药量、体外释放等进行考察。结果:优选黄芪注射液浓缩液微乳处方为:OP为乳化剂,丙三醇为助乳化剂,油酸乙酯为油相,四者比例为4∶4∶2∶2.58。线性范围:0.0041456~0.0404560 mg/ml,r=0.9991,平均回收率为96.60%,RSD为0.76%。平均载药量:黄芪总皂苷含量为13.54 mg/ml,黄芪甲苷含量为0.3885 mg/ml。微乳在24 h内缓慢释放。结论:该剂型稳定,方法简单,重现性好;体外释放有一定程度的缓释作用。

Preparation of Astragalus mongholicus injection concentrated solution microemulsion and evaluation releasing in vitro

Objective: Astragalus mongholicus injection concentrated solution microemulsion is prepared and estimated for quality and releasing in vitro.Method: Optimization anagraph was established by ternary phase diagram and stability investigation.AstragalosideIV was determined by HPLC,milkvetch root con-saponin was surveyed with UV Spectrophotometric.Releasing in vitro and carrying dosage was inspected.Results: Optimization anagraph of Astragalus mongholicus injection concentrated solution microemulsion was constituted by OP(emulsifier),Gly(subsidiary emulsifier),aethylis oleas(oil phase).Proportion is 4∶4∶2∶2.58.A linear limit of 0.0041456～0.0414560 mg/ml,r=0.9999,The average recovery was 96.60%.RSD=0.76%,the average carrying dosage: Milkvetch root con-saponin was 13.54 mg/ml,AstragalosideIV was 0.3885 mg/ml.Dosage in microemulsion was slow-released in 24 hour.Conclusions: The dosage form was stabile,means simple,reproducibility fine,releasing in vitro was delayed released.