WANG Ai-min, ZHU Di, CHEN Si-ying, et al. Influencing Factors Investigation of Stability of Compound Hongcao Freeze-dried Powder for Injection[J]. Chinese journal of experimental traditional medical formulae, 2015, 21(8): 5-8.
DOI:
WANG Ai-min, ZHU Di, CHEN Si-ying, et al. Influencing Factors Investigation of Stability of Compound Hongcao Freeze-dried Powder for Injection[J]. Chinese journal of experimental traditional medical formulae, 2015, 21(8): 5-8. DOI: 10.13422/j.cnki.syfjx.2015080005.
Influencing Factors Investigation of Stability of Compound Hongcao Freeze-dried Powder for Injection
Objective: To investigate stability of compound Hongcao freeze-dried powder for injection under strong light
high temperature and humidity conditions
and provide a reference for clinical drug safety and efficacy of this formulation. Method: According to the draft quality standards of compound Hongcao freeze-dried powder for injection
influencing factors test on its stability was carried out
changes of indexes including drug content
visible particles
particulate matter
hygroscopic weight
asepsis
pyrogen etc were determined.HPLC was employed to determine contents of isoorientin
orientin and scutellarin with mobile phase of acetonitrile-0.1% phosphoric acid (18:82) and detection wavelength at 350 nm. Result: Samples were loose-like brown substance
color was the 7th yellow standard solution
visible foreign matter
sterile
pyrogen and moisture absorption weight gain were in line with procisions.Peak areas and retention times of 17 chromatographic peaks in 10 batches of samples at high temperatures was stable with similarity of > 0.99
no vascular irritation
no hemolysis and agglomeration.Contents of isoorientin
orientin and scutellarin in samples were 5.80
3.90
16.50 mg
respectively.Each indicators all reached provisions of quality standards draft of compound Hongcao freeze-dried powder. Conclusion: Compound Hongcao freeze-dried powder for injection has good stability.