不同厂家藿香正气水质量比较研究及分析

目的:比较目前市场上流通的5个厂家藿香正气水的质量状况。方法:对5个厂家5批次药品进行装量差异和乙醇含量等常规检查,采用改进的高效液相色谱(HPLC)法测定药品中厚朴酚与和厚朴酚的含量,色谱柱为SHIMADZU HPLC-20AT ODSC18(150mm×4.6mm)柱,流动相为乙腈∶水=60∶40(2%冰乙酸),检测波长294nm。结果:改进HPLC方法测得和厚朴酚(r=0.9998)与厚朴酚(r=0.9999)在1～100mg·L-1范围内线性关系良好,厚朴酚的平均回收率为99.02%,RSD=1.78%;和厚朴酚的平均回收率为99.15%,RSD=0.97%。不同厂家生产的藿香正气水装量差异、乙醇含量、厚朴酚与和厚朴酚总量均符合2005年版《中国药典》中相关规定,但厚朴酚与和厚朴酚的含量差异较大。结论:建议进一步研究生产工艺,稳定原料药,并制定出科学、统一的质量标准。

Comparative Study and Analysis on the Quality of Huoxiang Zhengqi Tincture from Different Manufacturers

OBJECTIVE： To reflect the quality situation of Huoxiang zhengqi of 5 batches tincture on the market. METHODS： The load capacity and the content of ethanol of 5 batches of Huoxiang zhengqi tinctures from different manufacturers were investigated. The content of honokiol and magnolol was measured by improved HPLC method. The determination was performed on SHIMADZU HPLC-20AT ODS C18（150 mm×4.6 mm）column with acetonitrile-water （60 ∶ 40, 2% acetic acid ） as mobile phase at detection wavelength of 294 nm. RESULTS： The linear range of magnolol was 1～100 mg·L-1 （r=0.999 8） with an average recovery of 99.02% （RSD=1.78%）. The linear range of honokiol was 1～100 mg·L-1 （r=0.999 9） with an average recovery of 99.15% （RSD=0.97%）. The load capacity, the content of ethanol, the content of honokiol and magnolol in Huoxiang zhengqi tinctures from different manufacturers were in line with the requirement of Chinese Pharmacopeia. There was great difference in the content of honokiol and magnolol from different manufacturers. CONCLUSION： It is suggested to further study production process and material stability to formulate scientific and uniform quality standard.