舒心通脉口服液质量标准研究

Quality Standard for Shuxintongmai Oral Liquid

目的建立舒心通脉口服液的质量控制方法。方法采用薄层色谱法对制剂中三七、延胡索进行定性鉴别,采用高效液相色谱法(HPLC法)对制剂中主要成分丹参素钠和原儿茶醛进行含量测定。结果薄层色谱中斑点清晰,阴性对照无干扰;HPLC法精密度、重现性良好,丹参素钠进样量线性范围为0.8～4μg(r=0.9997),原儿茶醛进样量线性范围是0.16～0.8μg(r=0.9996),丹参素钠与原儿茶醛的加样回收率分别为102.1%和104.8%,RSD分别为0.79%和1.76%。结论所用方法可有效控制舒心通脉口服液的质量。

Objective To establish the quality standard for Shuxintongmai oral liquid, Methods Radix Notoginseng and rhizoma corydalis were identified by TLC. The contents of sodium salvianic A and protocatechuic aldehyde in Shuxintongmai oral liquid were determined by HPLC. Results The TLC spots developed were fairly and simply identical. HPLC was accurate and reproducible. Sodium salvianic A showed a good linear relationship at a range of 0, 8 -4 μg. The recovery rate was 102. 1% and RSD was 0. 79%. Protocatechuic aldehyde showed a good linear relationship at a range of 0. 16 -0, 8 μg. The recovery rate was 104. 8% and RSD was 1.76%, Conclusion These methods can be used for the quality control of Shuxintongmai oral liquid efectively.