注射用丹参多酚酸盐的稳定性再评价

Reevaluation of stability of the salvianolate for injection

目的建立丹参多酚酸盐中丹酚酸B含量测定方法,并补充丹参多酚酸盐与2种溶剂配伍后的稳定性数据。方法HPLC法测定丹酚酸B的含量,色谱柱为YMC-ODS C18（250 mm×4.6 mm,5μm）,流动相为乙腈-0.03%磷酸,流速为1.0 m L/min,检测波长为280 nm。同时将注射用丹参多酚酸盐与0.9%氯化钠溶液及5%葡萄糖溶液2种溶剂模拟临床用药比例配伍,进行丹参多酚酸盐稳定性考察。结果在浓度6.18~61.80μg/m L的范围内,丹酚酸B浓度与峰面积呈良好的线性关系,该方法的精密度、稳定性、重复性、准确度良好。样品中所含丹酚酸B含量在751.82~791.83 mg/g范围内波动,较稳定。室温状态下各配伍液的外观,p H值,稳定性和吸收度均无明显变化。配伍液在6 h内测得10μm以上的微粒95粒,25μm以下的微粒18粒,符合药典规定。结论以HPLC法测定丹酚酸B含量灵敏度高、重现性好,能够满足注射用丹参多酚酸盐的分析要求;注射用丹参多酚酸盐与溶剂配伍后6h内稳定,可安全用于临床。

Objective To establish the method of content determination of Sal B in salvianolate for injection,and supply the stability data of salvianolate for injection after the compatibility with 2 solvents. Methods The content of Sal B was determined by HPLC. The HPLC procedure was performed on the chromatographic column of YMC-ODS C18（ 250 mm × 4. 6 mm,5 μm）,and the mobile phase was acetonitrile-0. 03% phosphoric acid solution. The flow velocity was 1. 0 m L / min and the detection wavelength was 280 nm. At the same time,by simuating clinical medication,salvianolate for injection was mixed with 0. 9% sodium chloride solution and 5% glucose solution in order to investigate the stability of salvianolate. Results Within the range of concentration of 6. 18 ~ 61. 80 μg / m L,Sal B concentration and peak area showed a good linear relationship,the method was good in precision,stability,repeatability and accuracy. The content of Sal B fluctuated from 751. 82 mg / g to 791. 83 mg / g. At the room temperature,there was no significant change in appearance,p H value,stability and the absorbance. The mixed solution was measured 95 particles above 10 μm,18 particles below25 μm within 6 h. Conclusion The Sal B content determined by HPLC has high sensitivity,good reproducibility,and could meet the analysis requirements of salvianolic for injection,it is stabilized within 6h after mixing,it could be safely used in clinical.