NATURAL PRODUCT RESEARCH AND DEVELOPMENT ›› 2024, Vol. 36 ›› Issue (10): 1761-1776. doi: 10.16333/j.1001-6880.2024.10.013

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Study on the quality standard of fresh Leonurus japonicus Houtt. formula granules based on standard decoction

LIU Liao-yuan1,2,HONG Wan-min2,ZHANG Zhi-peng2,ZHANG Zheng2,CHENG Yu-jie2,HUANG Yao2,XU Jie2,SUN Dong-mei2*   

  1. 1Guangdong Provincial Key Laboratory of Research and Development in Traditional Chinese Medicine,Guangzhou 510095,China;2Guangdong Provincial Key Laboratory of Traditional Chinese Medicine Formula Granule,Guangdong Yifang 
    Pharmaceutical Co.,Ltd.,Foshan 528244,China
  • Online:2024-10-28 Published:2024-10-28

Abstract:

To establish the quality standard of fresh Leonurus japonicus Houtt. formula granules based on the standard decoction.Twenty batches of fresh L. japonicus medicinal materials were collected,according to the management standard for traditional Chinese medicine decocting room in medical institutions and the technical requirements for quality control and standard formulation of traditional chinese medicine formula granules,the decoction slices were processed,decocted,concentrated and freeze-dried to prepare  L. japonicus standard decoction,the paste rate,the content of leonurine hydrochloride and stachydrine hydrochloride of 20 batches of  L. japonicus standard decoction were determined,and the chromatogram which could characteriz the main chemical components was constructed to characterize fresh L.japonicus.At the same time,based on the the consistency with the paste rate,content of indicator components,and chromatogram with the standard decoction of fresh  L. japonicus,three batches of fresh  L. japonicus formula granules were produced in scale to verify the rationality of the formulated quality standards for fresh  L. japonicus formula granules.The results showed that the extract rate of 20 batches of fresh  L. japonicus standard decoction ranged from 4.43% to 8.02%,the contents of leonurine hydrochloride and stachydrine hydrochloride were 2.11-9.05 mg/g,16.86-82.59 mg/g,respectively the range of dry extract was 5.0%-8.5%,and the contents of leonurine hydrochloride and stachydrine hydrochloride were 1.0-5.3 mg/g,9.0-60.0 mg/g.And on the characteristic chromatogram 8 characteristic peaks were calibrated,respectively the information of formula granule pattern was consistent with standard decoction.So the quality standard of fresh  L. japonicus formula granules based on standard decoction is reasonable and feasible,which can provide reference for the formulation of national standard of fresh  L. japonicus formula granules.

Key words: fresh Leonurus japonicus, standard decoction, formula granules, paste rate, content, characteristic chromatogram

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