摘要
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 mL·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 fingerprint of Xiaoru San of compound preparation of traditional Chinese medicine,for the quality control of its products. Methods The separation was developed on a Kromat Universil XB C_（18）column（ 150 mm × 2. 1 mm,3 μm）,with acetonitrile- 0. 1%（ φ） phosphoric acid water as mobile phase with gradient elution,column temperature of 30 ℃,the flowrate of0. 1 mL·min^-1,detection wavelength at 254 nm. An UPLC fingerprint of Xiaoru San was set up by using＂traditional Chinese medicine chromatographic fingerprint similarity evaluation system software＂; 10 batches of preparation were evaluated for their similarity,and its characteristic peaks were identified. Furthermore,the main characteristic peaks in HPLC fingerprint of Xiaoru San were identified. Results A total of 16 common peaks were identified in the UPLC fingerprints of Xiaoru San,The similarity of 10 batches of Xiaoru San was about 0. 989 to 0. 998. Conclusions The established UPLC fingerprint of Xiaoru San is specific,precise,reproducible and stable,and can be used for quality evaluation of Xiaoru San. The above work can provide the experimental basis to improve overall quality control of Xiaoru San.
出处
《沈阳药科大学学报》
CAS
CSCD
北大核心
2016年第12期965-969,共5页
Journal of Shenyang Pharmaceutical University
