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目的:建立胃痛宁片中小茴香油含量均匀度的测定方法,考察胃痛宁片中小茴香油的含量均匀度。方法:以水杨酸甲酯为内标,采用GC法测定样品中小茴香油主成分反式茴香脑的含量。色谱条件:DB-FFAP毛细管柱(30 m×0.32 mm,0.25μm);柱温:145℃;进样口温度:180℃;FID检测器温度:230℃;载气为高纯氮,体积流量:0.8 ml·min-1,空气体积流量:400 ml·min-1,氢气体积流量:35 ml·min-1。对GC法进行方法学考察,并比较不同厂家及同一厂家不同批号胃痛宁片小茴香油的含量均匀度。结果:小茴香油中主要成分反式茴香脑在2.189~35.030μg·ml-1(r=0.999 9)浓度范围内呈良好的线性关系,平均回收率为100.06%,RSD为0.5%(n=9)。不同生产厂家的胃痛宁片以及同一厂家不同批号胃痛宁片中小茴香油含量均匀度均有明显差异。结论:该方法简便快捷,能准确测定该药品的含量均匀度,可用于该制剂的质量控制。
OBJECTIVE: To establish a method for the determination of evenness of fennel oil in Weitongning tablet and to investigate the content uniformity of fennel oil in Weitongning tablet. Methods: Methyl salicylate was used as internal standard. The content of trans-anethole in fennel oil was determined by GC method. Chromatographic conditions: DB-FFAP capillary column (30 m × 0.32 mm, 0.25 μm); column temperature: 145 ° C .; inlet temperature: 180 ° C .; FID detector temperature: 230 ° C .; carrier gas, : 0.8 ml · min-1, air volume flow rate: 400 ml · min-1, hydrogen volume flow rate: 35 ml · min-1. Methodological study on GC method was conducted and the content uniformity of fennel oil from different manufacturers of different batches of the same manufacturer and the same manufacturer was compared. Results: There was a good linear relationship between the content of trans-anethole in fennel oil and the concentration range of 2.189 ~ 35.030μg · ml-1 (r = 0.999 9) with the average recovery of 100.06% and the RSD of 0.5% (n = 9). Stomach Tongning film from different manufacturers and different batches of the same manufacturer Weiteng Ning tablet fennel oil content uniformity were significantly different. Conclusion: The method is simple and rapid, can accurately determine the content uniformity of the drug, can be used for the quality control of the preparation.