舒筋通络外用颗粒质量标准的研究(1)
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[摘要] 目的：建立舒筋通络外用颗粒的质量标准。方法：采用薄层鉴别法对制剂中的当归、桂枝、独活、大黄进行定性鉴别；用高效液相色谱法测定大黄素、大黄酚的含量。结果：薄层色谱可明显地检出当归、桂枝、独活、大黄；高效液相色谱法测得大黄素、大黄酚含量之和为34.50～35.24 mg/15 g，大黄素在0.010～0.500 μg范围内线性关系良好(r=0.999 9)，平均回收率为102.3%，RSD为0.93%(n=6)；大黄酚在0.025～1.250 μg范围内线性关系良好(r=0.999 9)，平均回收率为100.4%，RSD为1.30%(n=6)。结论：本方法简单、准确、专属性好，可用于舒筋通络外用颗粒的质量控制。
[关键词] 舒筋通络外用颗粒；薄层鉴别；高效液相色谱；大黄素；大黄酚；质量标准
[中图分类号] R927.2[文献标识码] A [文章编号] 1673-7210(2010)10(a)-038-04
Study on quality standard for Shujin Tongluo Granules
XIA Xi, LIU Ling
(Longjiang Hospital of Shunde District, Guangdong Province, Foshan 528318, China)
[Abstrcat] Objective: To establish the quality standard for Shujin Tongluo Granules. Method: Radix Angelicae Sinensis, Ramulus Cinnamomi, Radix Angelicae Pubescentis, Radix et Rhizoma Rhei in this medicine were identified by TLC. The content of Emodin and Chrysophanol in this medicine was determined by HPLC. Result: Radix Angelicae Sinensis, Ramulus Cinnamomi, Radix Angelicae Pubescentis, Radix et Rhizoma Rhei could be identified by TLC. The total content of Emodin and Chrysophanol were 34.50-35.24 mg per 15 g, the linear ranges of Emodin was at 0.010-0.500 μg (r=0.999 9),the average recovery was 102.3% with a RSD of 0.93% (n=6); the linear ranges of Chrysophanol was at 0.025-1.250 μg (r=0.999 9), the average recovery was 100.4% with a RSD of 1.30%. Conclusion: The method is simple, accurate, and can be used for the quality control of Shujin Tongluo Granules.
[Key words] Shujin Tongluo Granules; TLC; HPLC; Emodin; Chrysophanol; Quality standard
舒筋通络外用颗粒为顺德龙江医院制剂，由当归、大黄、独活、桂枝等十三味中药组成。采用部分药材粉碎成细粉，其余药材水煮醇沉制成稠浸膏后与细粉混合干燥而成的一种外用颗粒剂。使用时加水外洗、外敷均可，具有温经通络，祛瘀止痛的作用，用于跌打损伤，筋骨疼痛，关节不利。本文建立了当归、大黄、独活、桂枝的薄层色谱鉴别，并采用高效液相色谱法对其主要成分大黄素(C15H10O5)和大黄酚(C15H10O4)进行含量测定，现报道如下：
1 仪器与试药
1.1 仪器
Agilent 1100高效液相色谱仪、Agilent化学工作站(美国安捷伦科技有限公司)；METTLER AE240电子分析天平；CQ-20超声波清洗器。
1.2 试药
大黄素、大黄酚对照品及当归、独活、桂枝、大黄对照药材，均由中国药品生物制品检定所提供；舒筋通络外用颗粒，由广东省顺德龙江医院制剂室提供；甲醇光谱纯(天津四友化工厂)；薄层层析硅胶G(化学纯，中国青岛海洋化工集团公司)；其他试剂均为分析纯。
2 方法与结果
2.1 薄层色谱鉴别
2.1.1 当归、桂枝、独活薄层鉴别
因大黄的5个蒽醌类成分对当归、桂枝、独活的薄层色谱鉴别有干扰，故先用0.1 mol/L氢氧化钠溶液将其分离出去；曾用石油醚(60～90℃)-醋酸乙酯(4∶1)为展开剂进行薄层层析 ......
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