十味参归灌肠液的质量标准研究

Study on quality standard of Shiweishengui filling and intestinal juice

关键词:  十味参归灌肠液  质量标准  丹酚酸B  延胡索  丹参  桃仁  赤芍  TLC  HPLC

Key words:  Shiweishengui filling and intestinal juice  quality standard  Dan phenolic acid B  rhizoma Corydalis  Salvia miltiorrhiza  peach kernel  Radix Paeoniae Rubra  TLC  HPLC

摘要:

本文建立了十味参归灌肠液的质量标准。试验采用薄层色谱法（TCL）对制剂中的延胡索、丹参、桃仁、赤芍进行定性鉴别，采用高效液相色谱法（HPLC）对制剂中的丹酚酸B进行含量测定。结果显示，本研究建立的上述4味药材的薄层鉴别方法，色谱图特征斑点分离清晰、集中；建立的丹酚酸B含量测定方法，专属性和重复性高，丹酚酸B对照品进样量为54.55～545.5 μg时，与峰面积呈良好的线性关系，丹酚酸B回收率为102.77%，RSD=1.01%。本文建立的定性定量方法可有效控制中药制剂十味参归灌肠液的质量。

Abstract:

This article is to establish the quality standard of Shiweishengui filling and intestinal juice.Thin layer chromatography (TCL) was used to qualitatively identify rhizoma Corydalis,Salvia miltiorrhiza,peach kernel and Radix Paeoniae Rubra in the preparation.The content of Dan phenolic acid B in the preparation was determined by high performance liquid chromatography (HPLC).The results showed that the TLC identification methods for the above four herbs were established and the chromatogram was characterized by clear and concentrated spots.The established method for the determination of Dan phenolic acid B content had high specificity and repeatability.When the injection amount of Dan phenolic acid B reference substance was 54.55-545.50 μg,it had a good linear relationship with the peak area.The recovery rate of Dan phenolic acid B was 102.77%,RSD=1.01%.The qualitative and quantitative method established in this paper can effectively control the quality of the traditional Chinese medicine preparation "Shiweishengui filling and intestinal juice".