XU Chunfang, FU Zhiqin, YANG Hong, ZHANG Ni, LI Zexuan, ZOU Luoying, TAO Xia. Determination of in Vitro dissolution of Kunxian Capsules based on multi-index components[J]. Chinese Journal of Modern Applied Pharmacy, 2022, 39(9): 1149-1154. DOI: 10.13748/j.cnki.issn1007-7693.2022.09.003
    Citation: XU Chunfang, FU Zhiqin, YANG Hong, ZHANG Ni, LI Zexuan, ZOU Luoying, TAO Xia. Determination of in Vitro dissolution of Kunxian Capsules based on multi-index components[J]. Chinese Journal of Modern Applied Pharmacy, 2022, 39(9): 1149-1154. DOI: 10.13748/j.cnki.issn1007-7693.2022.09.003

    Determination of in Vitro dissolution of Kunxian Capsules based on multi-index components

    • OBJECTIVE To effectively control the internal quality of Kunxian capsules by dissolution determination of Kunxian capsules based on multi-index components. METHODS The analysis was performed on Agilent Zorbax SB-C18 column(250 mm×4.6 mm, 5 μm), using acetonitrile and 0.1% phosphoric acid solution as the mobile phase at a flow rate of 0.8 mL.min–1for gradient elution. The column temperature was 33 ℃, and the detection wavelength was 270 nm. The dissolution test was carried out with basket method, and using 900 mL pH 6.8 phosphate buffer as the dissolution medium, and the rotation speed was 100 r·min–1. The dissolution test of epimedin A, epimedin B, epimedin C and icariin in preparations were performed on HPLC, calculate and map the accumulative dissolution curve, and then compared the dissolution of products from different batches through the similarity factor(f2). RESULTS Good linearity relationships separated with epimedin A, epimedin B, epimedin C and icariin(r=0.999 9), and the average recovery were 100.9%(RSD=1.29%), 102.1%(RSD=1.18%), 100.8%(RSD= 1.30%) and 99.9%(RSD=0.92%), respectively, The dissolution curve of 4 components in Kunxian capsules from different batches had high similarity, the similarity factor(f2) were all > 67. CONCLUSION The method is convenient, accurate, practicable, it has good specificity, and can help to perfect the equality evaluation system of Kunxian capsule.
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