心脑通口服液质量标准提高研究  

Quality Standard Improvement of Xinnaotong Oral Liquid

作　　者：曾令军[1] 宋洪涛[1] 李蔚[2] 吴新安[2] 

机构地区：[1]南京军区福州总医院药学科,福建福州350025 [2]解放军105医院药剂科,安徽合肥230031

出　　处：《解放军药学学报》2016年第5期417-419,436,共4页Pharmaceutical Journal of Chinese People's Liberation Army

基　　金：基金项目:基于HPLC和TLC技术提高22种军队医疗机构非标准制剂质量标准的研究;No.14ZJZ17

摘　　要：目的提高并完善心脑通口服液的质量标准。方法修订现行标准中黄芪和川芎的TLC鉴别,增加泽泻的TLC鉴别;建立心脑通口服液中阿魏酸的HPLC含量测定方法,以DIKMA Diamonsil C18（4.6 mm×250 mm,5μm）为色谱柱,甲醇-0.1%磷酸溶液（26∶74）为流动相,检测波长为321 nm,流速为1.0 ml·min^-1。结果 TLC斑点清晰,分离良好,阴性无干扰;阿魏酸在9.72-97.2μg·ml-1范围内呈良好线性关系（r=0.9999）,平均加样回收率为98.89%。结论提高后的质量标准准确、稳定、专属性强,可用于心脑通口服液的质量控制。Objective To improve the quality standard of Xinnaotong oral liquid. Methods The TLC identification methods of astragali radix and Chuanxiong rhizoma were revised while those of alismatis rhizoma were established. The content of ferulic acid in Xinnaotong oral liquid was determined by HPLC on a column of DIKMA Diamonsil C18（ 4. 6 mm × 250 mm,5 μm） with a mobile phase of methanol-0. 1% phosphoric acid（ 26∶ 74）. The detection wavelength was 321 nm at a flow rate of 1. 0 ml·min^-1. Results TLC spots were clear and well-separated without any interference from the negative sample. A good linear relationship was established between the peak response and the concentration of ferulic acid over the range of 9. 72-97. 2 μg·ml-1（ r = 0. 9999）. The mean recovery of ferulic acid was 98. 89%. Conclusion The quality standard established is accurate,stable,and specific,which can be used for quality control of Xinnaotong oral liquid.

关 键 词：心脑通口服液 TLC HPLC 阿魏酸 质量标准 

分 类 号：R927.2[医药卫生—药学]