摘要
目的:对10家生产企业的29批健胃消食片采用HPLC法建立指纹图谱,为其质量控制提供有效的依据。方法:采用Kromasil C18柱,以乙腈-0.1%磷酸水溶液为流动相进行梯度洗脱,流速1.0ml/min,检测波长220nm,运用国家药典委员会指纹图谱相似度计算软件,确定指纹图谱共有峰,计算相似度。结果:通过对10家生产企业29批次样品的色谱图进行考察,发现之间差异较大;16批健民健胃消食片的色谱图相似,能建立指纹图谱,共确定了7个共有峰,其相似度均大于0.90。结论:29批次的样品无法共同建立指纹图谱进行评价;所建立的HPLC指纹图谱具有较好的精密度和重现性,可以有效表示健民健胃消食片的质量特点,能够有效控制产品质量。
Objective HPLC fingerprints of 29 batches of Jianwei Xiaoshi tablets which from 10 Pharmaceutical companies were established to provide an effective method of quality control for them. Methods Kromasil C18 column was used with acetonitrile -0. 1% phosphate aqueous as the mobile phase by gradient elution; the flow rate was 1.0ml/min, and the detection wavelength was at 220nm. Fingerprint similarity evaluation software was used to determine common fingerprint peaks, calculate the similarity. Results HPLC chromatograms of 29 batches of Jianwei Xiaoshi tablets which from 10 Pharmaceutical companies are divers; 7 common peaks were i- dentified in fingerprints from 16 batches of Jianwei Xiaoshi tablets of Jianmin, the similarity was greater than 0. 90. Conclusion 29 batches of Jianwei Xiaoshi tablets which from 10 Pharmaceutical companies cannot establish unified HPLC fingerprints; HPLC fingerprint established has better precision and reproducibility, and can effectively characterize the quality of Jianwei Xiaoshi tablets of Jianmin and control the product quality.
出处
《中国民族民间医药》
2016年第8期14-16,共3页
Chinese Journal of Ethnomedicine and Ethnopharmacy
