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目的建立了赤丹胶囊制剂的HPLC指纹图谱,用于控制赤丹胶囊的质量。方法采用HPLC法。色谱柱为Zorbax Extend-C18柱(250mm×4.6mm,5μm);流动相为甲醇-水(磷酸调pH3.0),梯度洗脱;体积流量为1mL/min;检测波长为254nm;柱温为20℃;进样量为10μL。中药色谱指纹图谱相似度评价系统的操作规范(版本2004A)计算。结果该制剂10批的指纹图谱相似度都达到0.90以上,制剂生产工艺稳定可行。结论本法可作为赤丹胶囊质量控制方法。
Objective To establish the HPLC fingerprint of Chidan capsule preparation for controlling the quality of Chidan capsules. Method using HPLC method. The column was a Zorbax Extend-C18 column (250mm×4.6mm, 5μm); the mobile phase was methanol-water (pH 3.0 adjusted by phosphoric acid), gradient elution; the volumetric flow rate was 1 mL/min; the detection wavelength was 254 nm; the column temperature was 20°C; injection volume 10 μL. Calculation of the Operating Specifications (Version 2004A) of the Chromatographic Fingerprint Similarity Evaluation System of Traditional Chinese Medicine. Results The similarity of fingerprints of the 10 batches of the preparation reached more than 0.90, and the preparation process was stable and feasible. Conclusion This method can be used as a quality control method for Chidan capsules.