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目的:建立参灵草口服液HPLC指纹图谱,客观评价参灵草口服液的质量状况。方法:建立参灵草口服液的指纹图谱。DIKMA SpursilTMC18-EP色谱柱(4.6 mm×250 mm,5μm),流动相乙腈-0.1%H3PO4梯度洗脱,流速1 m L·min-1,检测波长260 nm。通过指纹图谱,用参灵草口服液组方中各原药材和各有效成分为对照,鉴定参灵草口服液中各药材的主要成分和各有效成分。用指纹图谱的相似度评判参灵草口服液的质量。结果:指纹图谱的精密度峰、重复性和稳定性的保留时间平均RSD均<0.5%,峰面积平均RSD均<4%。参灵草口服液各组方药材的主要成分均在参灵草口服液指纹图谱中出现。在参灵草口服液中可鉴定出各药材中的活性成分。54批参灵草口服液水溶性成分相似度均>0.95,醇溶性成分相似度均>0.98。结论:参灵草口服液包含了各药材的主要有效成分。质量稳定,安全有效。指纹图谱方法可为参灵草口服液的质量评价提供较全面的信息。
Objective: To establish the HPLC fingerprints of Shenlingcao oral liquid and to evaluate the quality of Shenlingcao oral liquid objectively. Method: The fingerprint of Shenlingcao oral solution was established. DIKMA SpursilTMC18-EP column (4.6 mm × 250 mm, 5 μm) was used. The mobile phase was eluted with a gradient of acetonitrile-0.1% H3PO4 at a flow rate of 1 mL / min. The detection wavelength was 260 nm. Through the fingerprinting, the main ingredients and active ingredients of each ingredient in Shenlingcao Oral Liquid were identified by using the original medicinal materials and the active ingredients in the prescriptions of Shenlingcao Oral Liquid. Judging the Quality of Shenlingcao Oral Liquid by Fingerprint Similarity. Results: The average RSDs of retention times, precision peaks, repeatability and stability of fingerprints were all less than 0.5%, and the average RSD of peak area was less than 4%. Shenlingcao Oral Liquids The main ingredients of each group of herbs are in Linglingcao Oral Liquid fingerprint appears. In the ginseng oral liquid can identify the active ingredients in the herbs. The similarity of water-soluble components of 54 ginseng oral liquids were all> 0.95, and the similarity of alcohol-soluble components were all> 0.98. Conclusion: Shenlingcao oral liquid contains the main active ingredients of each medicine. Stable quality, safe and effective. The fingerprinting method can provide more comprehensive information for the quality evaluation of Shenlingcao Oral Liquid.