健脾祛湿丸(浓缩丸)质量标准研究  

Study on the Quality Standards of Jianpi Qushi Pills(Concentrated Pills)

作　　者：王萍 依孜提·帕力哈提 夏米西奴尔·艾买提江 WANG Ping;Yiziti·PALIHAQI;Xiamixinuer·AIMAITEJIANG(The Fourth Clinical Medical College of Xinjiang Medical University,Urumqi,Xinjiang,China 830000;Key Laboratory of Traditional Chinese Medicine Processing,Urumqi,Xinjiang,China 830000;School of Traditional Chinese Medicine,Xinjiang Medical University,Urumqi,Xinjiang,China 830000;Yining People's Hospital,Yining,Xinjiang,China 835000)

机构地区：[1]新疆医科大学第四临床医学院,新疆乌鲁木齐830000 [2]新疆中药炮制研究重点实验室,新疆乌鲁木齐830000 [3]新疆医科大学中医学院,新疆乌鲁木齐830000 [4]新疆维吾尔自治区伊宁市人民医院,新疆伊宁835000

出　　处：《中国药业》2025年第6期65-71,共7页China Pharmaceuticals

基　　金：新疆地产中药民族药新药研发项目[2016-01-03]。

摘　　要：目的建立健脾祛湿丸(浓缩丸)的质量标准。方法对全方药味分别进行薄层色谱(TLC)鉴别;采用高效液相色谱(HPLC)法测定落新妇苷、盐酸小檗碱、丹酚酸B的含量。结果土茯苓和黄柏、苦参、连翘、茯苓、白术、丹参、薏苡仁、白花蛇舌草的TLC图谱斑点清晰,分离度好,阴性对照无干扰。落新妇苷、盐酸小檗碱、丹酚酸B质量浓度分别在0.02~0.10 mg/mL,0.176~0.88 mg/mL,0.0144~0.072 mg/mL范围内与峰面积线性关系良好(r=0.9994,0.9994,0.9998,n=5),精密度、稳定性、重复性试验结果的RSD均小于2.0%;平均加样回收率分别为99.38%,101.53%,100.82%,RSD分别为1.94%,0.69%,1.31%(n=6)。结论该研究所建质量标准操作快速简便,结果准确,可用于健脾祛湿丸(浓缩丸)的质量控制。Objective To establish the quality standards of Jianpi Qushi Pills(concentrated pills).Methods Thin Layer Chromatography(TLC)was used for the identification of the herbal ingredients in the formula;High-Performance Liquid Chromatography(HPLC)was employed to determine the content of astilbin,berberine hydrochloride and salvianolic acid B.Results The TLC chromatograms of the herbs,including Smilacis Glabrae Rhizoma and Phellodendri Chinensis Cortex,Poria,Coicis Semen,Atractylodis Macrocephalae Rhizoma,Sophorae Flavescentis Radix,Forsythiae Fructus,Herba Hedyotidis,Salviae Miltiorrhizae Radix et Rhizoma,showed clear spots with good separation,and no interference from the negative control.The linear ranges of astilbin,berberine hydrochloride and Salvianolic acid B were 0.02 to 0.10 mg/mL,0.176 to 0.88 mg/mL,and 0.0144 to 0.072 mg/mL,respectively(r=0.9994,0.9994,0.9998,n=5).The results of precision,stability,and repeatability tests showed that the relative standard deviations(RSDs)were all less than 2.0%.The average recovery rates were 99.38%,101.53%,and 100.82%,with RSDs of 1.94%,0.69%,and 1.31%(n=6),respectively.Conclusion The established quality standards are simple,quick,and accurate,and can be used for quality control of Jianpi Qushi Pills(concentrated pills).

关 键 词：健脾祛湿丸(浓缩丸) 质量标准 薄层色谱法 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学] R927[医药卫生—药学] R286