GC法比较不同企业脑立清制剂中3种挥发性成分含量

Determination and Comparison of Three Volatile Components in Naoliqing Preparations from Different Enterprises by GC

目的建立气相色谱法(GC)同时测定脑立清系列制剂中薄荷脑、龙脑、冰片(以龙脑和异龙脑总和计)3种指标性成分,比较不同企业脑立清制剂3种成分含量差异。方法采用Agilent HP INNOWAX色谱柱(30 m×0.32 mm,0.25μm),恒流模式,流速:1 ml/min;分流进样,分流比:20:1,火焰离子化检测器(FID),测定3种指标成分的含量,并对结果进行统计学分析。结果 3种成分均能达到良好分离,薄荷脑、异龙脑、龙脑分别在0.0353~1.7630 mg/ml、0.0242~1.2122 mg/ml、0.0253~0.7591 mg/ml浓度范围内与色谱峰峰面积呈良好的线性关系;3种剂型平均回收率分别在99.5%~100.4%,99.1%~99.9%,99.6%~100.2%之间。频数分布图中,薄荷脑、龙脑和冰片3个指标基本呈正态分布;3个指标成分的箱式分布图,分布状况基本一致,不同企业间产品质量存在差异。不同剂型之间因生产工艺的差异,3种指标性成分的含量也存在一定差异。结论该方法同时测定多种成分,方法准确可靠,专属性强,可用于脑立清系列制剂中挥发性成分的质量控制。

Objective To establish a GC method for simultaneous determination of three components in different Naoliqing preparations, including menthol, borneol and synthetic borneol(calculated as the sum of borneol and isoborneol), and compare the content differences of three components in Naoliqing preparations from different enterprises. Methods The analysis was carried out on Agilent HP INNOWAX chromatographic column(30 m×0.32 mm,0.25 μm), using constant flow mode at a flow rate of 1 ml/min;split injection was adopted, and the split ratio was 20:1. Flame ionization detector(FID) was used to determine the contents of three index components, and the results were statistically analyzed. Results The results showed that the three components were well separated. The linear ranges of menthol, isoborneol and borneol were 0.0353-1.7630 mg/ml, 0.0242-1.2122 mg/ml and 0.0253-0.7591 mg/ml,respectively. The average recoveries were 99.5 %-100.4 %, 99.1 %-99.9 % and 99.6 %-100.2 %, respectively. The frequency distribution diagrams showed that three indicators including menthol, borneol and synthetic borneol were basically normally distributed;in the box-type distribution diagrams, distributions of three indicator components were basically the same, and there were differences in product quality between different enterprises. Due to the differences in production processes of different dosage forms, there were also certain differences in the contents of three indicator components. Conclusion The method was specific, precise and reliable. It can be used for the quality control of different Naoliqing preparations.