Establishment of preparation process and quality standard for Zhenggu Pills
10.3969/j.issn.1001-1528.2025.09.006
- VernacularTitle:正骨丸制备工艺及其质量标准建立
- Author:
Wen-ming ZHANG
1
;
Zi-fang FENG
1
;
Li-hong GU
1
;
Ping QIN
1
;
Zhen-hua BIAN
1
;
Min-min HU
1
;
Xiao-wei CHEN
1
Author Information
1. 南京中医药大学附属无锡医院,江苏无锡 214071
- Publication Type:Journal Article
- Keywords:
Zhenggu Pills;
preparation process;
quality standard;
orthogonal test;
single factor test;
TLC;
HPLC
- From:
Chinese Traditional Patent Medicine
2025;47(9):2863-2869
- CountryChina
- Language:Chinese
-
Abstract:
AIM To establish the preparation process and quality standard for Zhenggu Pills.METHODS With decoction time,decoction frequency and water addition as influencing factors,comprehensive score for extract yield and transfer rates of epicatechin and naringin as an evaluation index,the decoction process was optimized by orthogonal test.With sugarless paste relative density,medicinal powder fineness,sugarless paste-corn starch ratio,drying temperature and drying time as influencing factors,soft material traits,pill formability,moisture and disintegration time limit as evaluation indices,the formability process was optimized by single factor test.TLC was adopted in the qualitative identification of Dipsaci Radix,salt-processed Psoraleae Fructus,cooked Rhei Radix et Rhizoma and Notoginseng Radix et Rhizoma.HPLC was used for the content determination of paeoniflorin and naringin.RESULTS The optimal decoction process was determined to be 0.5 h for decoction time,two times for decoction frequency,and 10 times for water addition,the comprehensive score was 0.93.The optimal formability process was determined to be 1.21-1.22 for sugarless paste relative density,80 mesh for medicinal powder fineness,1∶0.17-1∶0.18 for sugarless paste-corn starch ratio,70 ℃ for drying temperature,and 24 h for drying time,good soft material traits and pill formability were observable,and moisture and disintegration time limit accored with 2020 edition of Chinese Pharmacopoeia requirements.The TLC spots were clear without negative interference.Two constituents showed good linear relationships within 61.30-490.41 μg/mL(r=0.999 8)and 3.27-26.18 μg/mL(r=0.999 8),whose average recoveries were 100.15％and 98.15％with the RSDs of 0.55％and 2.30％,respectively.CONCLUSION This stable,reliable and specific method can be used for the production and quality evaluation of Zhenggu Pills.
