| 刘厚权.清热散结胶囊指纹图谱技术研究[J].实用中西医结合临床,2018,18(11): |
| 清热散结胶囊指纹图谱技术研究 |
| Study on Fingerprint Mapping of Qinghezanzanjie Capsule |
| 投稿时间：2018-07-25 修订日期：2018-08-16 |
| DOI： |
| 中文关键词: 清热散结胶囊 质量标准 高相液相色谱指纹图谱 |
| 英文关键词: qingzhi sanjie capsule Quality standards High phase liquid chromatography fingerprint |
| 基金项目: |
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| 摘要点击次数: 819 |
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| 中文摘要: |
| 目的：建立清热散结胶囊的高效液相色谱指纹图谱色谱方法，为该产品的质量控制提供参考。方法：以十八烷基硅烷键合硅胶为固定相；流动相A为乙腈，流动相B为0.05%磷酸水溶液，流速为1.0ml/min，柱温为25℃-35℃，检测波长0min-220nm，15min-280nm，30min-325nm，40min-360nm，采用梯度洗脱法，建立清热散结胶囊的HPLC指纹图谱色谱方法,并进行不同批次的清热散结胶囊的HPLC指纹图谱色谱的相似度评价分析。结果：建立的清热散结胶囊HPLC指纹图谱色谱方法精密度、重现性、溶剂稳定性良好；色谱图谱共有12个特征峰；对不同批次的清热散结胶囊产品的指纹图谱相似度大于0.90。结论：本研究所建立的清热散结胶囊HPLC指纹图谱与对照品图谱的相似度均大于0.90，说明该方法能有效表征其质量，为清热散结胶囊的质量控制提供依据。 |
| 英文摘要: |
| Abstract: objective: to establish the hplc fingerprint chromatography method for qingzhengzanjie capsule, and provide reference for the quality control of the product. Methods: The 18 alkyl silane was used as the stationary phase. The flow phase A is acetonitrile, the flow phase B is an aqueous phosphate solution of 0.05 %, the flow rate is 1.0 ml/min, the column temperature is 25 °C -35 °C, the detection wavelength is 0min-220 nm, 15min-280 nm, 30min-325 nm, 40min-360nm, using the gradient elution method, HPLC fingerprint chromatography method was established, and the similarity of HPLC fingerprint chromatography was evaluated in different batches. results: The HPLC fingerprint chromatogram method of the deheated bulk capsule was established. The precision, reproducibility and solvent stability were good. There are 12 characteristic peaks in chromatography; Fingerprint similarity was greater than 0.90 for different batches of heat-clearing capsule products. Conclusion: The similarity between HPLC fingerprint profile and the reference map of the heat-clearing capsules established in this paper is greater than 0.90, which indicates that the method can effectively characterize the quality of the capsules and provide a basis for the quality control of the heat-clearing capsules.
Key words: qingzhi sanjie capsule; Quality standards; High phase liquid chromatography fingerprint; |
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