黄芩苷溶解度及注射用冻干粉的制备

Solubility of Baicalin and Freeze-Dried Powder Preparation for Injection

目的:研究黄芩苷溶解度及注射用黄芩苷冻干粉制备工艺。方法:采用紫外分光光度法测定加入不同增溶剂和不同pH值的磷酸盐缓冲液后黄芩苷粉末在水中的溶解度,选择出最优基质和最大溶解度,并对黄芩苷水溶液进行冷冻干燥,以成品的外观、复溶性及澄明度为标准考察注射用黄芩苷冻干粉的制备工艺。结果:磷酸盐缓冲液(pH=7.0)可增加黄芩苷在水中的溶解度,黄芩苷溶解度为75.82mg·mL-1。最佳冻干工艺采用快冻法,加入5%的甘露醇,升华温度为25℃,干燥8h。结论:黄芩苷溶解度增加,适合制备注射用冻干粉。该工艺制备的黄芩苷成型性好,水溶性好并且制剂稳定。

Objective：This study is about the baicalin solubility and the injection of baicalin preparation of freeze-dried powder.Methods：Using UV spectrophotometry by adding different solvents and different pH values phosphate buffer solution of baicalin after the powder in water solubility,select the optimal substrate and the maximum solubility,and baicalin aqueous solution freeze-dried,to the appearance of finished products,re-soluble,and clarity as a standard of baicalin for injection preparation of freeze-dried powder injection process.Results：Phosphate buffer（pH = 7.0）increase of baicalin in water solubility,the solubility of baicalin to 75.82mg·mL^-1.Optimum freeze-drying process using fast freeze method,adding 5% of mannitol,sublimation temperature is 25℃,dry 8 hours.Conclusion：Increase solubility of baicalin,suitable for preparation of freeze-dried powder for injection.The process of baicalin prepared by forming good,good water-soluble and stable formulations.