Stability research of Xiaoer Ganmaoning Oral Liquid based on chromatographic peak matching and image sensory evaluation.
10.19540/j.cnki.cjcmm.20210525.302
- Author:
Qi WANG
1
;
Jia-Liang HU
2
;
Ruo-Fei DU
2
;
Fei WU
3
;
Xiao LIN
1
;
Yi FENG
2
Author Information
1. College of Chinese Materia Medica, Shanghai University of Traditional Chinese Medicine Shanghai 201203, China.
2. Engineering Research Center of Modern Preparation Technology of Traditional Chinese Medicine of Ministry of Education,Shanghai University of Traditional Chinese Medicine Shanghai 201203, China.
3. College of Chinese Materia Medica, Shanghai University of Traditional Chinese Medicine Shanghai 201203, China Engineering Research Center of Modern Preparation Technology of Traditional Chinese Medicine of Ministry of Education,Shanghai University of Traditional Chinese Medicine Shanghai 201203, China.
- Publication Type:Journal Article
- Keywords:
HPLC characteristic chromatogram;
Xiaoer Ganmaoning Oral Liquid;
image processing;
precipitate;
quality control;
stability
- MeSH:
Chromatography, High Pressure Liquid/methods*;
Drugs, Chinese Herbal/chemistry*;
Quality Control;
Scutellaria baicalensis/chemistry*
- From:
China Journal of Chinese Materia Medica
2022;47(6):1573-1581
- CountryChina
- Language:Chinese
-
Abstract:
The high performance liquid chromatography(HPLC) characteristic chromatogram of Xiaoer Ganmaoning Oral Liquid(oral liquid for short) was established. The medicinal materials corresponding to characteristic peaks, their index components and ranges of similarity with the reference chromatograms were clarified. The similarity between the characteristic chromatograms of 10 batches of the oral liquid and the reference chromatogram was higher than 0.994. Eighteen characteristic peaks were identified, which were derived from different medicinal materials including Scutellariae Radix, Arctii Fructus, Lonicerae Japonicae Flos, Gardeniae Fructus and Forsythiae Fructus. Further, 11 characteristic peaks were assigned by the comparison with reference substances as chlorogenic acid, neochlorogenic acid, cryptochlorogenic acid, isochlorogenic acid A, isochlorogenic acid C, baicalin, baicalein, wogonin, scutellarin, forsythiaside A and arctiin. Also, the characteristic chromatogram of precipitate in the oral liquid was established, and the similarity between characteristic chromatograms of 10 batches of the precipitate and the reference chromatogram was higher than 0.940. The 14 characteristic peaks originating from the precipitate and those from the oral liquid were consistent in retention time, and the content of all index components in the precipitate was lower than 5% of that in the oral liquid. Moreover, the stability of precipitate during the accelerated stability test was explored with filtration and Matlab-based image sensory evaluation. The precipitate mass and precipitation degree both increased over the stability test duration significantly. The stability of the oral liquid was used as a model system in this study to establish the integrated quality control system which related to medicinal materials, preparations and precipitate with HPLC characteristic chromatograms and image sensory evaluation, which lays a foundation for the exploration of the quantity value transfer of the oral liquid.
