保肝降脂颗粒质量标准

Quality Standards of Baogan Jiangzhi Granules

摘要:

目的：建立保肝降脂颗粒的质量标准。方法：采用TLC对保肝降脂颗粒中丹参、香附、片姜黄进行定性鉴别；通过HPLC同时测定保肝降脂颗粒中绿原酸和丹酚酸B含量，流动相乙腈（A）-0.5%甲酸水溶液（B）梯度洗脱（0~10 min，10%A；10~20 min，10%~15%A；20~30 min，15%~20%A；30~53 min，20%~30%A；53~60 min，30%~10%A），绿原酸、丹酚酸B检测波长分别为327，286 nm。结果：建立的丹参、香附、片姜黄TLC鉴别方法中斑点清晰且阴性对照无干扰。绿原酸、丹酚酸B线性范围分别为0.050 8~0.571 5，0.326~3.26 μg，平均回收率分别为100.56%（RSD 2.00%），100.50%（RSD 1.59%）。结论：建立的方法定性专属性强、定量准确度高，适用于保肝降脂颗粒的质量控制。

Abstract:

Objective: To establish quality standards of Baogan Jiangzhi granules. Method: TLC was used to identify Salviae Miltiorrhizae Radix et Rhizoma, Cyperi Rhizoma and Rhizoma Wenyujin Concisum in Baogan Jiangzhi granules.HPLC was adopted to determine contents of chlorogenic acid and salvianolic acid B with mobile phase of acetonitrile(A)-0.5% formic acid(B) gradient elution(0-10 min, 10%A;10-20 min, 10%-15%A;20-30 min, 15%-20%A;30-53 min, 20%-30%A;53-60 min, 30%~10%A), detection wavelength of these two ingredients were 327 and 286 nm, respectively. Result: Established TLC had clear spots without interference of the negative control sample.Linear ranges of chlorogenic acid and salvianolic acid B were 0.050 8-0.571 5 and 0.326-3.26 μg, average recoveries were 100.56%(RSD 2.00%) and 100.50%(RSD 1.59%), respectively. Conclusion: These methods was accurate and specific, which were suitable for quality control of Baogan Jiangzhi granules.