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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。
Objective: To compare the quality of Huoxiangzhengqi water among the five manufacturers currently circulating on the market. METHODS: Five batches of five manufacturers were tested for differences in the amount of loading and the ethanol content. Routine HPLC method was used to determine the content of honokiol and honokiol in the drug. The column was SHIMADZU. HPLC-20AT ODSC18 (150 mm x 4.6 mm) column, mobile phase acetonitrile:water = 60:40 (2% glacial acetic acid), detection wavelength 294 nm. RESULTS: The HPLC method showed good linearity between honokiol (r=0.9998) and magnolol (r=0.9999) in the range of 1 to 100 mg·L-1, and the average recovery rate of honokiol was 99.02%. RSD = 1.78%; the average recovery of honokiol was 99.15%, and RSD = 0.97%. The differences in water loading capacity, ethanol content, honokiol and honokiol produced by different manufacturers were in line with the relevant regulations in the 2005 edition of the Chinese Pharmacopoeia, but the differences in the content of honokiol and honokiol were greater. Big. Conclusion: It is recommended to further study the production process, stabilize the API, and formulate scientific and uniform quality standards.