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目的建立中药复方制剂消乳散的UPLC指纹图谱,对制剂进行质量控制。方法采用Kromat Universil XB C_(18)色谱柱(150 mm×2.1 mm,3μm),以乙腈-质量分数为0.1%的磷酸水为流动相,进行梯度洗脱,柱温:30℃,流速:0.1 m L·min-1,检测波长:254 nm;建立消乳散的UPLC指纹图谱,运用“中药色谱指纹图谱相似度评价系统软件”对10批制剂进行相似度评价,并指认其特征峰。结果建立的消乳散UPLC指纹图谱共标示出16个共有峰,10批制剂的指纹图谱与对照指纹图谱的相似度的均值为0.989~0.998,均大于0.90,满足质量要求。结论上述建立的UPLC指纹图谱精密度、重复性和稳定性均良好,可以用于消乳散的质量评价,可为消乳散的整体质量控制提供科学依据。
OBJECTIVE To establish the UPLC fingerprinting of Xiaoyan San, a traditional Chinese medicine preparation for quality control of the preparation. Methods The column was eluted with Kromat Universe XB C 18 column (150 mm × 2.1 mm, 3 μm) using acetonitrile - 0.1% phosphoric acid as mobile phase at a column temperature of 30 ℃ and a flow rate of 0.1 m L · min-1, the detection wavelength was 254 nm. The UPLC fingerprints of Xiao Xia Powder were established, and the similarity of 10 batches of preparations was evaluated by using the similarity evaluation system of Chinese traditional medicine chromatographic fingerprinting system . Results The UPLC fingerprints of Xiao milk powder UPLC showed a total of 16 common peaks. The average of the similarity of fingerprints and control fingerprints of 10 batches of preparations was 0.989 ~ 0.998, all of which were greater than 0.90, satisfying the quality requirements. Conclusion The UPLC fingerprints established above are of good precision, repeatability and stability and can be used to evaluate the quality of consumer milk powder, which can provide a scientific basis for the overall quality control of consumer milk powder.