摘要
目的:建立芪葵方基准样品的高效液相色谱(HPLC)指纹图谱及多指标成分含量测定方法。方法:根据中药饮片临床煎煮规范,制备15批芪葵方基准样品,并建立基准样品的HPLC指纹图谱,明确指纹图谱中峰归属、相似度范围以及干膏率和指标性成分含量范围,建立芪葵方基准样品的质量评价体系。结果:15批基准样品共标定24个共有峰,且相似度大于0.96。基准样品中8种指标性成分含量分别为毛蕊异黄酮葡萄糖苷0.0327~0.0603 mg/mL、芦丁0.0418~0.0644 mg/mL、金丝桃苷0.4976~0.7845 mg/mL、2,3,5,4’-四羟基二苯乙烯-2-O-β-D-葡萄糖苷0.1124~0.2097 mg/mL、异槲皮苷0.3387~0.5420 mg/mL、棉花皮素-8-O-葡萄糖醛酸1.0336~1.5524 mg/mL、毛蕊异黄酮0.0094~0.0163 mg/mL、芒柄花黄素0.0025~0.0046 mg/mL。15批基准样品的干膏率范围为27.78%~33.86%,平均干膏率为30.81%。结论:芪葵方基准样品质量评价方法科学可行且质量稳定,可作为芪葵方制剂开发工艺研究以及生产过程质量控制的依据。
Objective:To establish an HPLC fingerprint and multi index component content determination method for the benchmark sample of Qikui formula.Methods:According to the clinical decoction standards of traditional Chinese medicine decoction,15 batches of Qikui formula benchmark samples were prepared,and HPLC fingerprint of the benchmark samples were established.The peak attribution and similarity range in the fingerprint chromatogram were clarified,and the dry paste rate and indicator component content range were determined.A quality evaluation system for Qikui formula benchmark samples was established.Results:A total of 24 common peaks were calibrated for 15 batches of benchmark samples,and the similarity was greater than 0.96.The content of the eight indicator components in the benchmark sample were 0.0327-0.0603 mg/mL(calycosin-7-glucoside),0.0418-0.0644 mg/mL(rytin),0.4976-0.7845 mg/mL(hyperoside),0.1124-0.2097 mg/mL(2,3,5,4'-tetrahydroxy-silbene-22-O-β-D-glucoside),0.3387-0.5420 mg/mL(isoquercitrin),1.0336-1.5524 mg/mL(gossypetin 8-O-beta-D-glucuronide),0.0094-0.0163 mg/mL(calycosin),and 0.0025-0.0046 mg/mL(formononetin),respectively.The range of dry paste yield for 15 batches of benchmark samples was 27.78%-33.86%,with an average dry paste yield of 30.81%.Conclusions:The quality evaluation method for the benchmark sample of Qikui formula is scientifically feasible and stable,and it can serve as a basis for the research of Qikui formula development process and quality control throughout the production process.
作者
倪昌荣
管敏
施敏
NI Changrong;GUAN Min;SHI Min(Afffliated Hospital of Nanjing University of Chinese Medicine,Nanjing Jinagsu 210029,China)
出处
《中医药导报》
2025年第8期79-85,共7页
Guiding Journal of Traditional Chinese Medicine and Pharmacy
基金
江苏省中医院院级课题(Y2022ZR22)。
关键词
芪葵方
基准样品
高效液相色谱
指纹图谱
多指标成分
含量测定
质量评价
Qikui formula
benchmark sample
high performance liquid chromatography
fingerprint chromatogram
multi index components
content determination
quality evaluation
