亮菌甲素注射液与不同溶媒的配伍稳定性考察

Study on compatible stability of armillarisin injection with different kinds of solvents

目的 考察亮菌甲素与6种常用输液的配伍稳定性及其荧光强度随溶剂pH值的变化情况.方法 采用高效液相色谱法测定亮菌甲素注射液与0.9％氯化钠注射液、5％葡萄糖注射液、10％葡萄糖注射液、葡萄糖氯化钠注射液、木糖醇注射液及乳酸钠林格注射液配伍后亮菌甲素的含量,采用pH测定仪测定其酸碱度变化,同时观察溶液的颜色及澄明度.配置不同pH梯度的缓冲盐溶液,考察亮菌甲素在不同pH环境下荧光强度的变化.结果 本实验所建立的色谱条件对亮菌甲素注射液的检测专属性好,亮菌甲素在5.0 - 80 μg/mL浓度范围内与其峰面积呈良好的线性关系（r2 =0.999 9）.高、中、低3种浓度的平均回收率分别为103.72％（RSD=0.17％）、103.98％（RSD=0.01％）、103.67％（RSD=0.25％）;6种配伍溶液在24 h时测得的药物含量均在98.61％ - 100.29％范围内.当溶液pH为5-8时,呈蓝色荧光黄色液体;pH为4-5时,肉眼观察微弱蓝色荧光;pH为2-4时,肉眼观察为无色透明液体,在紫外灯下可见微弱蓝色荧光.结论 亮菌甲素在不同pH值的溶媒中的荧光强度不同,荧光的强弱不影响药物的稳定性,该药物与6种常用输液配伍后24 h内稳定性良好.

Objective To investigate compatible stability of armillarisin injection with 6 kinds of commonly used infusions, and observe the changs of fluorescence intensity with armillarisin in different pH of solvents. Methods The content changes of armillarisin injection were determined by HPLC after combined with 0. 9% sodium chloride inje cetion,5% glucose injection, 10% glucose injection,glucose and sodium chloride injection,xylitol injection and sodium lactate ringer＇s injection, pH detector was used to determine the changes of pH value. The color and clarity were ob served at the same time. The change of fluorescence intensity with armillarisin in different pH environments was investi gated. Results Armillarisin showed a good linear relationship within the range of 5.0 - 80 ixg/mL （ r2 = 0. 999 9 ）. The average recovery of the three different concentrations of armillarisin was 103.72% （RSD =0. 17% ） ,103.98% （RSD = 0. 01% ） ,103.67% （RSD =0. 25% ）. The content of armillarisin were obtained 98.61% - 100. 29% after 24 h. When the pH value was 5 - 8, the color of the solvent of armillarisin showed the blue fluorescent yellow, pH value was 4 - 5, the color of the solvent of armillarisin showed the weak blue fluorescence with eyes. pH value was 2 - 4, the color of the solvent of armillarisin showed weak blue fluorescence under UV light. Conclusion The different fluorescence in- tensity of arrnillarisin in different pH of solvents which does not affect the stability of armillarisin, and the stability for armillarisin compatible with the 6 kinds of commonly used infusions within 24 h is good.