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.