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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: To study the solubility of baicalin and preparation technology of baicalin lyophilized powder for injection. Methods: The solubility of baicalin powder in water was determined by UV spectrophotometry after adding different solubilizer and different pH value of phosphate buffer. The optimum matrix and the maximum solubility were selected. The baicalin aqueous solution was freeze-dried. The appearance, re-solubility and clarity as the standard test preparation of baicalin for injection freeze-dried powder preparation. Results: Phosphate buffer (pH = 7.0) increased the solubility of baicalin in water. The solubility of baicalin was 75.82 mg · mL-1. The best freeze-drying process using fast freezing method, adding 5% mannitol, sublimation temperature of 25 ℃, dried 8h. Conclusion: The baicalin solubility increases, suitable for the preparation of lyophilized powder for injection. The baicalin prepared by the process has good formability, good water solubility and stable formulation.