| 摘要: |
| 目的：建立基于标准汤剂栀子炭配方颗粒的质量标准，为其质量评价提供依据。方法： 通过15 批标准汤剂建立栀子炭中栀子苷的含测方法;建立特征指纹图谱进行相似度评价;通过液质联用技术对6个共有峰进行分析鉴定;制备3批配方颗粒，测定出膏率及栀子苷的含量，计算转移率。通过特征指纹图谱对栀子炭药材、饮片和标准汤剂、中间体和配方颗粒进行相关性研究。结果： 通过方法学考察，建立了栀子苷的含测方法和特征指纹图谱;15 批标准汤剂的栀子苷含量为80.6～127.1 mg/g，栀子苷从饮片到标准汤剂的转移率范围在63.3%~101.5 %;3批配方颗粒含量为78.6～82.5 mg/g，标准汤剂到配方颗粒的转移率范围为61.6%～69.8%。栀子炭标准汤剂和配方颗粒的指纹图谱均呈现6个特征峰，分别鉴定为山栀苷、京尼平苷酸、羟异栀子苷、鸡矢藤次苷甲酯、京尼平龙胆二糖苷和栀子苷;15批栀子炭的标准汤剂和3批配方颗粒的指纹图谱相似度均＞0.9。药材、饮片、标准汤剂、中间体和配方颗粒的指纹图谱相关性分析发现6个共有特征峰在不同样品中均有出现，且相似度＞0.98。结论：本研究建立了基于标准汤剂栀子炭配方颗粒的质量标准，为栀子炭配方颗粒的工艺研究提供了基础。 |
| 关键词: 栀子炭 标准汤剂 栀子苷 特征指纹图谱 配方颗粒 质量标准 |
| DOI： |
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| Establishment of quality standard based on the standard decoction of gardenia charcoal formulated granules |
| SHEN Bingbing,ZHANG Dan,CHEN Lin |
| (Institute of Traditional Chinese Medicine Resources，Hunan Academy of Chinese Medicine，Changsha 410013，Hunan，China) |
| Abstract: |
| Objective: To establish the quality standard based on the standard decoction of gardenia charcoal formulated granules，and to provide a basis for quality assessment.Methods: A total of 15 batches of standard decoction were used to establish the method for determining the content of geniposide in gardenia charcoal，and characteristic fingerprints were established to assess similarity.Liquid chromatography-mass spectrometry was used for the identification of 6 common peaks;3 batches of formulated granules were prepared to measure extract yield and the content of geniposide，and the transfer rate was calculated.Characteristic fingerprints were used to perform correlation analysis of the medicinal material，decoction pieces，standard decoction，intermediates，and formulated granules of gardenia charcoal.Results: The method for determining the content of geniposide and characteristic fingerprints were established after methodological validation.The content of geniposide was 80.6-127.1 mg/g in the 15 batches of standard decoction，and the transfer rate of geniposide from decoction pieces to standard decoction ranged from 63.3% to 101.5%.The content of geniposide was 78.6-82.5 mg/g in the 3 batches of formulated granules，and the transfer rate of geniposide from standard decoction to formulated granules ranged from 61.6% to 69.8%.There were 6 characteristic peaks in the fingerprints of both standard decoction and formulated granules of gardenia charcoal，which were identified as shanzhiside，geniposidic acid，hydroxyisogeniposide，scandoside methyl ester，genipin gentiobioside，and geniposide.The fingerprints showed a similarity of >0.9 for all 15 batches of standard decoction and 3 batches of formulated granules.The correlation analysis showed that all 6 common characteristic peaks were observed in the medicinal material，decoction pieces，standard decoction，intermediates，and formulated granules，with a similarity of >0.98.Conclusion: This study establishes the quality standard based on the standard decoction of gardenia charcoal formulated granules，which provides a basis for research on the processing of gardenia charcoal formulated granules. |
| Key words: gardenia charcoal standard decoction geniposide characteristic fingerprint formulated granules quality standard |
