Effect of 60Co Irradiation on 3 Active Ingredients in Compound Hemostatic Capsules / 中国药师

ABSTRACT

Objective: To establish an HPLC method for the simultaneous determination of 3 active components in compound he-mostatic capsules and investigate the content changes before and after 60Co-γ ray irradiation. Methods: An Agilent-C18column (250 mm×4. 6 mm, 5 μm) was adopted and the flow rate was 1. 0 ml·min-1. The mobile phase consisted of acetonitrile-0. 5% phosphor-ic acid solution (triethylamine was used to adjust pH to 6) with gradient elution, the detection wavelength was 254 nm (0-35 min) and 281 nm (35-55 min), and the column temperature was 35℃. The compound hemostatic capsules were irradiated at 5, 8 and 10 kGy, respectively, and the contents of the 3 active components in compound hemostatic capsules were compared before and after the radia-tion,and the t-test was applied to investigate the significance. Results: Typhaneoside,isorhamnetin-3-O-neohesperidin and tetrahydro-palmatine respectively within the concentration range of 0. 018-0. 11 mg·ml-1,0. 020-0. 120 mg·ml-1and 0. 011-0. 066 mg·ml-1 showed a good linear relationship with the peak area. The average recovery was 97. 7% , 98. 7% and 99. 3% with the RSD of 0. 9% , 0. 9% and 0. 5% , respectively (n=6). After the irradiation, the contents of the three active components in compound hemostatic capsules all showed changes. Under the dose of 8 kGy, the content changes of typhaneoside and isorhamnetin-3-O- neohesperidin showed no statistical significance (P>0. 05),and when the dose increased to 10 kGy,the content of tetrahydropalmatine exhibited sig-nificant difference (P<0. 05). Conclusion: The established determination method for compound hemostatic capsule shows such ad-vantages as high recovery, good repeatability, simple operation and promising separation, which can be used as a quality control meth-od for compound hemostatic capsules. The sterilization effect of 60Co-γ ray irradiation on compound hemostatic capsules is significant without notable changes in the active components. When the irradiation dose is equal to or below 5 kGy,the change of each component is not obvious,which can provide reference for the radiation sterilization of compound hemostatic capsules.