复方沙塔干口服液质量标准研究

·86· Chinese Journal of Information on TCM Nov.2015 Vol.22 No.11 复方沙塔干口服液质量标准研究

余双英1,2,刘绣华1,3,张凤2,朴淑娟2,陆文铨2

1.河南大学化学化工学院,河南 开封 475004；

2.第二军医大学附属长征医院药学部,上海 200003；

3.河南大学天然药物与免疫工程重点实验室,河南 开封 475004

摘要：目的建立复方沙塔干口服液的质量标准。方法采用薄层色谱法对该制剂中的君药川芎进行专属

性鉴别；采用高效液相色谱法对川芎中有效成分阿魏酸进行含量测定。色谱柱：Diamonsil C18柱(4.6 mm×250 mm,

5 μm)；流动相：甲醇-1%冰醋酸,梯度洗脱(0～5 min,35%甲醇；5～8 min,35%→23%甲醇；8～22 min,23%甲醇)；检测波长：322 nm；流速：1.0 mL/min；柱温：30 ℃；进样量：5 μL。结果阿魏酸进样量在0.039 4～0.630 0 μg范围内线性关系良好(r＝0.999 7,n＝7),平均加样回收率为98.22%,RSD＝2.62%(n＝6)。结论本

研究所建立的质量标准结果准确,灵敏度高,重复性良好,可用于复方沙塔干口服液的质量控制。

关键词：复方沙塔干口服液；阿魏酸；高效液相色谱法；薄层色谱法；质量标准

DOI：10.3969/j.issn.1005-5304.2015.11.024

中图分类号：R284.1 文献标识码：A 文章编号：1005-5304(2015)11-0086-03

Study on Quality Standards for Compound Shatagan Oral Liquid YU Shuang-ying1,2, LIU Xiu-hua1,3, ZHANG Feng2, PIAO Shu-juan2, LU Wen-quan2(1.College of Chemistry and Chemical Engineering, Henan University, Kaifeng 475004, China；2.Department of Pharmacy, Changzheng Hospital, Second Military Medical University, Shanghai 200003, China；3.Key Laboratory of Natural Drug and Immune Engineering of Henan Province, Henan University, Kaifeng 475004, China)

Abstract：Objective To establish the quality standards for compound Shatagan Oral Liquid. Methods Chuanxiong Rhizoma was identified by TLC. The content of ferulic acid was determined by HPLC. Separation was performed on a Diamonsil C18 column (4.6 mm × 250 mm, 5 μm) with a mobile phase consisting of methanol-1% acetic acid solution in gradient elution (0-5 min, 35% methanol；5-8 min, 35%→23% methanol；8-22 min, 23% methanol) at 30 ℃；The flow rate was 1.0 mL/min；The injection volume was 5 μL；The detection wavelength was 322 nm. Results Ferulic acid showed a good linear relationship in the range of 0.039 4-0.630 0 μg (r＝0.999 7, n＝7). The average recovery was 98.22% and RSD was 2.62% (n＝6). Conclusion The method is reliable, sensitive and with repeatability, which can be used as the quality control method for compound Shatagan Oral Liquid.

Key words：compound Shatagan Oral Liquid；ferulic acid；HPLC；TLC；quality standard

复方沙塔干口服液是第二军医大学附属长征医院自主研制,由川芎和水蛭2味药组成的复方制剂,具有活血化瘀、散结行气、祛风止痛作用,临床用于治疗中风偏身麻木、半身不遂等病症。方中川芎属活血化瘀药,功效活血行气、祛风止痛,具有扩张血管、抗血栓、改善微循环等作用,其主要有效成分为阿魏酸[1-2]。该制剂现行质量标准比较简单,为保证各批次

基金项目：军队中药口服液类特色制剂的质量标准研究(14ZJZ02-4)

通讯作者：陆文铨,E-mail：lwqp@ 产品质量稳定可控,实现临床用药的疗效稳定、安全、可靠,本试验采用薄层色谱法对该制剂中的君药川芎进行专属性鉴别,并采用高效液相色谱法(HPLC)测定有效成分阿魏酸的含量。

1 仪器与试药

Agilent 1200高效液相色谱仪(Agilent,美国),包括G1311A输液泵、G1329A自动进样器、G1316A柱温箱、G1314B-VWD紫外检测器、Chemstation色谱工作站；十万分之一天平(Sartorius CPA225D,德国)；超声仪(SK7200H型,上海科导超声仪器有限公司)。 复方沙塔干口服液(批号分别为131015、131102、