Effect of 60Co-γ Ray Irradiation on the Four Components in Tongmai Granules / 中国药师

ABSTRACT

Objective: To study the effect of 60Co-γ ray irradiation on the contents of danshensu,protocatechuic aldehyde,puerarin and salviamolic acid B in Tongmai granules by HPLC. Methods: An Agilent ZORBAX Eclipse XDB C18(2) column (250 mm × 4. 6 mm,5 μm) was adopted and the wavelength of UV detection was 280 nm at the flow rate of 1. 0 ml·min-1. The mobile phase consisted of 0. 1% phosphoric acid (B) and acetonitrile (A) with gradient elution, and the column temperature was 35℃. Tongmai granules were irradiated by 60Co-γ ray respectively at 0, 2, 5,10 and kGy,the contents of the active ingredients were compared before and after the irradiation. Results: The linear range of danshensu,protocatechuic aldehyde,puerarin and salviamolic acid B was 0. 098-4. 925 μg, 0. 028-1. 411 μg, 0. 378-18. 882 μg and 0. 218-10. 888 μg, respectively. The average recovery was 99. 8% , 97. 7% , 99. 9% and 99. 9% , respectively. When the radiation dose was not more than 2 kGy, the contents of the five components did not change significantly (P>0. 05). After 5 kGy radiation, the contents of protocatechuic aldehyde and salviamolic acid B were signifi-cantly different (P <0. 05). Conclusion: The dose of 60Co ray should be controlled not more than 2 kGy, and the sterilization method is safe and effective for Tongmai granules.