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目的:建立蒲参胶囊的指纹图谱分析方,为蒲参胶囊的质量控制提供新方法。方法:采用RP-HPLC,AgilentZORBAX SB-C18色谱柱(4.6 mm×250 mm,5μm),流动相0.1%磷酸水溶液-乙腈系统,线性梯度洗脱,检测波长254 nm,进样量10μL。结果:建立了蒲参胶囊的HPLC指纹图谱,以二苯乙烯苷为参照峰,确立了蒲参胶囊指纹图谱中其余18共有峰,测定了12批蒲参胶囊HPLC指纹图谱与对照图谱的相似度。结论:建立的HPLC指纹图谱有较好的精密度、重复性和稳定性,适用于蒲参胶囊的质量控制。
OBJECTIVE: To establish a fingerprinting analysis method for Po-shen capsule and to provide a new method for the quality control of Po-shen capsule. Method: The mobile phase was eluted with 0.1% phosphoric acid aqueous solution - acetonitrile on a Agilent ZORBAX SB-C18 column (4.6 mm × 250 mm, 5 μm) using RP-HPLC with a linear gradient of 254 nm. The injection volume was 10 μL. Results: The HPLC fingerprints of Pu Shen Capsules were established, and the other 18 common peaks in the fingerprint of Pu Shen Capsule were established by using stilbene glycosides as the reference peak. The similarity of the HPLC fingerprints and control maps of 12 batches of Pu Shen Capsules was determined . Conclusion: The established HPLC fingerprint has good precision, repeatability and stability, and is suitable for the quality control of Pu Shen Capsules.