| 引用本文:阮玥，林燕，张晓燕，余世荣，石金敏.四逆汤高效液相指纹图谱的建立及含量测定[J].世界中医药,2020,(20):. |
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| 四逆汤高效液相指纹图谱的建立及含量测定 |
| Establishment of High Performance Liquid Chromatographic Fingerprint of Sini Decoction and Its Content Determination |
| 投稿时间：2019-04-30 |
| DOI：10.3969/j.issn.1673-7202.2020.20.003 |
| 中文关键词: 高效液相色谱法 四逆汤 指纹图谱 次乌头碱 6-姜酚 甘草苷 含量测定 药理实验 |
| English Keywords:High performance liquid chromatography Sini Decoction Fingerprint Hypaconitine 6-gingerol Glycyrrhizin Content determination Pharmacological experiment |
| 基金项目:湖北省卫计委和计划生育委员会科研项目(WJ2015MB232) |
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| 中文摘要: |
| 目的：通过高效液相色谱法（HPLC）对四逆汤进行指纹图谱的建立。方法：对HPLC法进行常规的可靠性方法学考察，包括专属性、精密度、稳定性等，然后进一步采用HPLC对四逆汤进行指纹图谱的建立，在此基础上比较10批不同四逆汤样品的相似度，并进行含量测定。结果：1）线性回归考察中结果显示在一定的线性范围内四逆汤中的次乌头碱对照品、6-姜酚对照品、和甘草苷对照品溶液线性关系考察均显示良好。2）乌头碱、6-姜酚和甘草苷在精密度试验、稳定性试验和重复性试验中RSD值分别为0.47%、0.86%、0.39%，2.11%、2.63%、1.95%，1.58%、1.97%、1.02%，均显示四逆汤在HPLC检测中的精密度、稳定性和重复性均较好。3）四逆汤中次乌头碱、6-姜酚和甘草苷的含量测定中10个不同批次的四逆汤在3个成分中差异均无统计学意义（P<0.05），其平均测得量为（12.86±0.18）μg/mL、（62.91±0.78）μg/mL、（349.96±0.26）μg/mL。结论：采用高效液相对四逆汤进行指纹图谱的建立和相似度比较分析及含量测定发现，四逆汤的质量稳定性均一，可作为临床疗效的稳定性提供药理学实验依据。 |
| English Summary: |
| To establish the fingerprint of Sini Decoction by high performance liquid chromatography(HPLC).Methods:The routine reliability methodology of HPLC method was investigated，including specificity，precision and stability etc.，and HPLC was used for the establishment of fingerprint of Sini Decoction.On this basis，the similarity of 10 batches of different Sini Decoction samples were compared，and the content was determined.Results:1)The results of linear regression investigation showed within a certain linear range，the linear relationship of the subaconitine reference substance，6-gingerol reference substance，and glycyrrhizin reference substance solution in Sini Decoction showed good results.2)The RSD values of aconitine，6-gingerol and glycyrrhizin in precision test，stability test and repeatability test were 0.47%，0.86%，0.39%，2.11%，2.63%，1.95%，1.58%，1.97% and 1.02%，respectively，which showed that Sini Decoction had good precision，stability and repeatability in HPLC detection.3)In the determination of the contents of sub-aconitine，6-gingerol and glycyrrhizin in Sini Decoction，there was no significant difference among the 3 components in 10 different batches of Sini Decoction，and the average contents were(12.86±0.18)ug/mL,(62.91±0.78)ug/mL and(349.96±0.26)ug/mL.Conclusion:HPLC relative to Sini Decoction was used for the establishment of fingerprints，similarity comparison analysis and content determination found that that Sini Decoction had uniform quality and stability，which could provide pharmacological experimental basis for the stability of clinical efficacy. |
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