中成药2024,Vol.46Issue(7) :2157-2163.DOI:10.3969/j.issn.1001-1528.2024.07.006

不同工艺对养肝降草合剂整体质量的影响

Effects of different processes on the overall quality of Yanggan Jiangcao Mixture

刘玉鑫 朱亚苹 田立元 吴磊
中成药2024,Vol.46Issue(7) :2157-2163.DOI:10.3969/j.issn.1001-1528.2024.07.006

不同工艺对养肝降草合剂整体质量的影响

Effects of different processes on the overall quality of Yanggan Jiangcao Mixture

刘玉鑫 1朱亚苹 1田立元 1吴磊1
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作者信息

  • 1. 南京中医药大学附属医院,江苏 南京 210029;南京中医药大学第一临床医学院,江苏 南京 210029
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摘要

目的 考察提取、浓缩、离心、灭菌工艺对养肝降草合剂整体质量的影响.方法 分析采用菲罗门Luna C18色谱柱(250 mm×4.6 mm,5 μm);流动相乙腈-0.1%磷酸,梯度洗脱;体积流量1 mL/min;柱温20℃.建立HPLC指纹图谱,测定红景天苷、栀子苷、连翘酯苷A、特女贞苷、甘草酸、白术内酯Ⅲ的含量,并计算其转移率.结果 15批不同工艺下样品指纹图谱中有 20 个共有峰,相似度大于 0.950.6 种成分在各自范围内线性关系良好(r≥0.999 0),平均加样回收率 96.96%~106.69%,RSD 0.97%~2.87%,转移率大于 80%,总转移率大于 90%.结论 养肝降草合剂在不同工艺下均具有较好的稳定性.

Abstract

AIM To investigate the effects of extraction,concentration,centrifugation,sterilization processes on overall quality of Yanggan Jiangcao Mixture.METHODS The analysis was performed on a 20℃ thermostatic Phenomenex Luna C18column(250 mm×4.6 mm,5 μm),with the mobile phase comprising of acetonitrile-0.1% phosphoric acid flowing at 1 mL/min in a gradient elution manner.The HPLC fingerprints were established,after which the contents of salidroside,geniposide,forsythoside A,specnuezhenide,glycyrrhizic acid and atractylenolideⅢ,along with the calculation of their transfer rates.RESULTS There were twenty common peaks in the fingerprints for fifteen batches of samples under different processes with the similarities of more than 0.950.Six constituents showed good linear relationships within their own ranges(r≥0.999 0),whose average recoveries were 96.96%-106.69% with the RSDs of 0.97%-2.87%,and the transfer rates and total transfer rates were more than 80% and more than 90%,respectively.CONCLUSION Yanggan Jiangcao Mixture demonstrates good stability under different processes.

关键词

养肝降草合剂/提取工艺/浓缩工艺/离心工艺/灭菌工艺/HPLC指纹图谱/含量测定

Key words

Yanggan Jiangcao Mixture/extraction process/concentration process/centrifugation process/sterilization process/HPLC fingerprints/content determination

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基金项目

国家中医药管理局2023年中药创新能力提升项目(k2023BZ04)

江苏省中医院院级课题(Y22051)

江苏省中医院科主任提升项目(Y2022ZR19)

出版年

2024
中成药
国家食品药品监督管理局,信息中心中成药信息站,上海中药行业协会

中成药

CSTPCD北大核心
影响因子:1.217
ISSN:1001-1528
参考文献量15
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