Quality Standard for Infantile Bronchitis Traditional Chinese Medicine Lotion / 中国药师

ABSTRACT

Objective:To establish the quality standard for infantile bronchitis traditional Chinese medicine lotion. Methods:TLC was used for the qualitative identification of Ephedra herba, Paeonia lactiflora Pall. , Poria cocos, Fructus aurantii and Epimedium brev-icornu Maxim. . HPLC was used for the content determination of ephedrine hydrochloride, pseudoephedrine hydrochloride and paeoni-florin. The chromatography conditions for ephedrine hydrochloride and pseudoephedrine hydrochloride were as follows an AElichrom Pdar-Phenyl Polyphenyl ether-bonded phenyl-bonded silica column (250 mm × 4. 6 mm, 5μm) was used, the mobile phase was aceto-nitrile-0. 2% phosphoric acid solution (199), the flow rate was 1. 0ml·min-1, the detection wavelength was 210 nm, the column temperature was 30℃ and the injection volume was 10 μl. The chromatography conditions for paeoniflorin were as followsan Inertsil ODS-3 C18 column (250 mm × 4. 6 mm, 5 μm) was used, the mobile phase was acetonitrile-0. 1% phosphoric acid solution (1585), the flow rate was 1. 0 ml·min-1, the detection wavelength was 230 nm, the column temperature was 30℃ and the injection vol-ume was 10 μl. Results:The TLC results of Ephedra herba, Paeonia lactiflora Pall. , Poria cocos, Fructus aurantii and Epimedium brevicornu Maxim. showed clear spots with good resolution. Ephedrine hydrochloride, pseudoephedrine hydrochloride and paeoniflorin had a good linear relationship within the range of 10.11-101.10 μg·ml-1(r=0.9996), 10.08-100.80 μg·ml-1(r=0.9991) and 20.50-102.5 μg·ml-1(r =0.9996), respectively. The average recovery was 98.80% (RSD =1.87%, n =6), 98.77%(RSD=1. 72%, n=6) and 99. 57% (RSD=1. 56%, n=6), respectively. Conclusion: The established quality standard can be used for the quality control of infantile bronchitis traditional Chinese medicine lotion.