Study on quality standard for Kangfuling granules / 医学研究生学报

ABSTRACT

Objective Kangfuling granules can be used for the treatment of radiation damage , but its quality criteria has not been established .This paper aimed to establish the quality criteria of Kangfuling granules to control its quality . Methods Radix as-tragali and Radix angelicae sinensis in the formula both were identified qualitatively by TLC .The content of astragaloside IV was exam-ined by HPLCAgilent Zorbax Extend-C18 (4.6 mm ×250 mm, 5μm) was used as the chromatographic column .The mobile phase was consisted of acetonitrile-water (3268) with a flow rate at 1.0 mL/min.The evaporative light scattering detector was used to detect the compound.The content of astragaloside IV and ferulaic acid was examined by HPLC Agilent Zorbax SB-C18 (4.6 mm ×250 mm, 5 μm) was used as the chromatographic column .The mobile phase was consisted of acetonitrile-0.085% phosphoric acid water (1783) with a flow rate at 1.0 mL/min.The wave length was 320 nm and column temperature was set at 35℃. Results The same color spot was shown in the chromatogram of the test sample and the control sample in the corresponding position with no interference of negative control.The linear range for Astragaloside IV 0.030 6 mg/mL~0.612 0 mg/mL with R2 =0.999.The RSD of stability test was 2.17%.The RSD of precision test was 1.89%.The RSD of re-peatability test was 1.58%.The average recovery was 101.26%. The linear range for ferulaic acid 0.24-4.80 μg/mL with R2 =0.999.The RSD of stability test was 1.37%.The RSD of precision test was 0.83%.The RSD of repeatability test was 1.14%.The average recovery was 98.39%.This product was tentatively calculat-ed according to the dry matter , the amount of Astragaloside IV and ferulaic acid should not be less than 0.19 mg/g and 0.08 mg/g, re-spectively. Conclusion In this study, the established TLC was used for the qualitative identification of Kangfuling granules , and the content of Astragaloside IV and ferulaic acid was not less than 0.19 mg and 0.08 mg in per gram of Kangfuling granules , respectively. The established standard is suitable for the quality control of Kangfuling granules .