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刘丽琴.解毒软肝合剂质量控制方法研究 [J].浙江中西医结合杂志,2022,32(3):
解毒软肝合剂质量控制方法研究
Study on Quality Control Method of Jieduruangan Mixture
投稿时间:2021-08-26  修订日期:2021-12-22
DOI:
中文关键词:  解毒软肝合剂  炙甘草  叶下珠  赤芍  芍药苷  质量控制
英文关键词:Jieduruangan mixture  Glycyrrhizae Radix et Rhizoma Praeparata Cummelle  Phyllanthus urinaria L  Paeoniaeradix Rubra  paeoniflorin  quality control
基金项目:
作者单位E-mail
刘丽琴* 杭州市红十字会医院 juan.wang@farfavour.com 
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中文摘要:
      目的 建立解毒软肝合剂的质量评价体系。方法 采用TLC法对合剂中炙甘草、叶下珠、赤芍进行定性鉴别;使用HPLC法定量检测合剂中芍药苷含量;选择Diamonsil C18色谱柱(250×4.6 mm,5 μm);选择乙腈(A)-0.1%磷酸水溶液(B)作为流动相,进行梯度洗脱,条件为0~30 min 14% A; 30~60 min 14~90% A; 60~61 min 90~14% A;61~70 min 14% A;以230 nm作为检测波长;以1.0 mL.min-1为流动性流速;柱温设定为30 ℃;每次进样10μL。结果 TLC方法展开的色谱图分离度好,斑点清晰。HPLC方法结果显示,芍药苷在0.1177~0.5885μg范围内线性关系良好,平均回收率达到99.06%。结论 TLC与HPLC相结合的质量评价体系呈现较好的精密度、重复性、稳定性,可运用于解毒软肝合剂的质量控制。 关键词:解毒软肝合剂;炙甘草;叶下珠;赤芍;芍药苷;质量控制
英文摘要:
      Study on Quality Control Method of Jieduruangan Mixture LIIU Liqin1*, WANG Ying1,CHEN Hongbin2(1.Zhejiang Integrated Traditional and Western Medicine Hospital, Hangzhou 310003, China;2.Zhejiang Huisong Pharmaceutical Co., Ltd., Hangzhou 310005, China) Objective: abstract To establish the quality control method of Jieduruangan mixture. Methods Thin layer chromatography(TLC)was used to identify Glycyrrhizae Radix et Rhizoma Praeparata Cum melle;Phyllanthus urinaria L;Paeoniaeradix Rubr. Establish an HPLC method for determination the content of paeoniflorin. The method was performed with Diamonsil C18(4.6 mm×250 mm,5?μm) column and gradient elution with acetonitrile (A)-0.1% phosphoric acid (B) as the mobile phase,gradient elution;0~30 min 14% A; 30~60min 14~90 A; 60~61 min 90~14 A;61~70min 14% A, the detection wavelength was 230 nm and the flow rate was 1.0 mL·min-1, the column temperature was 30℃ and the injection volume was 10μL. Results TLC showed clear spots and good resolution. Paeoniflorin showed a good linear relationship in the range of 0.1177~0.5885μg, the average recovery of paeoniflorin was 99.06%. Conclusion The method has good precision, repeatability, stability,it can be used for the quality control of Jieduruangan mixture. KEY WORDS: Jieduruangan mixture; Glycyrrhizae Radix et Rhizoma Praeparata Cum melle; Phyllanthus urinaria L;Paeoniaeradix Rubra; Paeoniflorin; Quality control
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