Study on the Improvement of Mailuoning Granule's Quality Standard

OBJECTIVE To improve the product quality standard of Mailuoning granules. METHODS The existing quality standards were added and revised, the thin layer chromatography(TLC) identification method of Achyranthis Bidentatae Radix and Scrophulariae Radix in the formula was revised, and the HPLC identification method of Dendrobii Caulis was added, the HPLC determination method of Scrophulariae Radix was revised. RESULTS The TLC patterns of Achyranthis Bidentatae Radix and Scrophulariae Radix in Mailuoning granules showed spots of the same color on the same position as the corresponding control medicinal materials or the reference substance, and the negative control had no interference. The HPLC pattern of Dendrobii Caulis for testing the product chromatogram presented a chromatographic peak consistent with the retention time of the reference chromatographic peak, and the negative control had no interference. The content of Scrophulariae Radix was determined using Alltima^TM C₁₈ chromatographic column(4.6 mm×250 mm, 5 μm), the mobile phase was acetonitrile-0.03% phosphoric acid solution(gradient elution), the flow rate was 1.0 mL·min^-1; the detection wavelength was 203 nm(0-20 min) and 280 nm(20-40 min). The column temperature was 25℃. The linear range of harpagide and harpagoside was 0.070 51-1.057 6 and 0.021 42-0.321 4 μg(r>0.999 7); the average recoveries were 97.87% and 100.96%(RSD<2%, n=6). CONCLUSION The developed methods is simple, accurate, reliable and specific, which can improve the quality standard of this preparation.