中成药

目的 评价苓桂术甘汤质量。方法 分析采用BP C₁₈ Plus色谱柱(250 mm×4.6 mm, 5μm);流动相0.1%磷酸-乙腈，梯度洗脱；体积流量0.8 mL/min;柱温30℃;检测波长220 nm。建立基准样品、现代制剂、传统高压锅代煎样品、智能代煎样品(各3批)HPLC指纹图谱。以甘草苷为内标，计算芹糖甘草苷、肉桂酸、桂皮醛、甘草酸、白术内酯Ⅲ、白术内酯Ⅱ相对校正因子，一测多评法测定其含量。再进行主成分分析、聚类分析。结果 12批样品指纹图谱中有26个共有峰，相似度均大于0.95,其中智能代煎样品与基准样品的相似度最高。7种成分在各自范围内线性关系良好(r≥0.999 6),平均加样回收率90.72%～104.16%,RSD 0.48%～6.11%,一测多评法所得结果与外标法接近。各批样品聚为2类，现代制剂、智能代煎样品对基准样品的还原度较高。结论 该方法稳定可靠，可用于苓桂术甘汤各用药形式的质量控制，其智能代煎样品可最大程度还原基准样品的物质基础分布。

AIM To evaluate the quality of Linggui Zhugan Decoction.METHODS The analysis was performed on a 30 ℃ thermostatic BP C₁₈ Plus column(250 mm×4.6 mm, 5 μm), with the mobile phase comprising of 0.1%phosphoric acid-acetonitrile flowing at 0.8 mL/min in a gradient elution manner, and the detection wavelength was set at 220 nm. The HPLC fingerprints for reference samples, modern preparations, traditional pressure cooker-decocting samples and intelligent decocting samples(3 batches each) were established. Liquiritin was used as an internal standard to calculate the relative correction factors of liquiritin apioside, cinnamic acid, cinnamaldehyde, glycyrrhizic acid, atractylenolide Ⅲ and atractylenolide Ⅱ, after which the content determination was made by quantitative analysis of multi-components by single-marker(QAMS). Subsequently, principal component analysis and cluster analysis were performed.RESULTS There were 26 common peaks in the fingerprints for 12 batches of samples with the similarities of more than 0.95, among which the intelligent decocting samples demonstrated the highest similarity to the reference samples. Seven constituents showed good linear relationships within their own ranges(r≥0.999 6), whose average recoveries were 90.72%-104.16%with the RSDs of 0.48%-6.11%. The result obtained by QAMS approximated those obtained by external standard method. Various batches of samples were clustered into 2 types, the modern preparations and intelligent decocting samples exhibited high reducibilities to reference samples.CONCLUSION This stable and reliable method can be used for the quality control of various dosage forms of Linggui Zhugan Decoction, whose intelligent decocting samples can preserve the material composition of reference samples to the greatest extent.