不同厂家香丹注射液中丹参素钠和原儿茶醛含量的比较

目的：建立以高效液相色谱法同时测定香丹注射液中丹参素钠和原儿茶醛含量的方法,并比较不同厂家生产的香丹注射液中丹参素钠和原儿茶醛含量的差异,以控制香丹注射液的质量。方法：色谱柱为AlltimaC18柱（150mm×4.6mm,5μm）,流动相为甲醇-0.5%冰醋酸（90∶10）,检测波长为280nm。结果：丹参素钠、原儿茶醛的进样量分别在0.26～1.58μg（r=0.9995）、0.12～0.73μg（r=0.9996）范围内与各自峰面积的积分值呈良好的线性关系;丹参素钠、原儿茶醛的平均回收率分别为99.8%、99.7%,RSD分别为0.4%（n=6）、0.4%（n=6）。共测定12家企业生产的16批香丹注射液,丹参素钠、原儿茶醛含量范围分别为1.02～2.08mg·mL^-1、0.24～0.51mg·mL^-1。结论：该方法简便、准确、无干扰,可用于同时测定香丹注射液中丹参素钠和原儿茶醛的含量;不同厂家生产的香丹注射液之间存在显著质量差异,建议厂家重视原药材质量,改善制剂工艺,提高产品质量。

Contents of Sodium Danshensu and Protocatechuic Aaldehyde in Xiangdan Injections from Different Manufacturers

OBJECTIVE：To establish a HPLC method for the simultaneous determination of the contents of sodium Danshensu and protocatechuic aldehyde in Xiangdan injection and compare the differences in the contents of sodium Danshensu and protocatechuic aldehyde in Xiangdan injections from different manufacturers so as to control the quality of Xiangdan injections.METHODS：The chromatographic column was Alltima C18 column（150 mm × 4.6 mm,5 μm）,and.The mobile phase consisted of methanol -0.5% acetic acid（90：10） and detection wavelength was set at 280 nm.RESULTS：The linear ranges of sodium Danshensu and protocatechuic aldehyde were 0.26-1.58 μg（r = 0.999 5） and 0.12-0.73 μg（r = 0.999 6） respectively;and the average recovery rates of which were 99.8% and 99.7% respectively,with RSDs of 0.4%（n = 6） and 0.4（n = 6）,respectively.The contents of sodium Danshensu and protocatechuic aldehyde in a total of 16 batches of Xiangdan injections from 12 manufacturers determined were 1.02-2.08 mg·mL -1and 0.24-0.51 mg·mL1,respectively.CONCLUSION：This method is simple,accurate and free of interference,thus it can be used for the simultaneous determination of sodium Danshensu and protocatechuic aldehyde in Xiangdan injections;There are significant differences in the quality of Xiangdan injection from different manufacturers,therefore,manufacturers should attach great importance to the quality of the crude drugs,improve the preparation techniques and the quality of products.