Research on quality control of the potential allergic ingredient scutellarin in Shuganning Injection
10.19778/j.chp.2026.01.006
- VernacularTitle:舒肝宁注射液中潜在致敏成分野黄芩苷的质量控制研究
- Author:
HE Feng
;
CAO Lu
;
YANG Cuiping
;
LI Jing
;
ZHANG Quan
;
WANG Jinjin
;
Lü Yanni
;
HAN Shengli
- Publication Type:Journal Article
- Keywords:
scutellarin;
Shuganning Injection;
high performance liquid chromatography;
determination
- From:
Drug Standards of China
2026;27(1):0037-0042
- CountryChina
- Language:Chinese
-
Abstract:
Objective: Scutellarin in Shuganning injection has potential allergenicity and is prone to causing anaphylactoid reactions. There is an urgent need to establish a simple and rapid chromatographic quantitative method to achieve the limit control of scutellarin in Shuganning injection.
Methods: For scutellarin, HPLC method was used in the quantitative analysis using a Shim-pack GIS C18 (2.1 mm×150 mm, 5 μm) column. The mobile phase was a blend of 0.1% trifluoroacetic acid in water and acetonitrile, and gradient elution progress was applied for the whole process. The flow rate was 0.3 mL·min-1 and the column temperature was maintained at 37 ℃. The detecting wavelength was 320 nm.
Results: The linear regression equation was y=51 456x-27 352, the correlation coefficient r=0.999 8, namely the calibration curve was linear in the range of 1.02-102.00 μg·mL-1; the average recovery was 103.76%; the detection and quantification limit for determining scutellarin was 0.16 μg·mL-1 and 0.57 μg·mL-1, respectively; the injection sample was stable at room temperature for 48 h.
Conclusion: This method is easy to operate, reproducible and has high accuracy, thus can be used for quality control of Shuganning injection.
- Full text:202606291108097797520260206.pdf
