Page 51 - 《中国药房》2021年12期

醋五味子配方颗粒的特征图谱建立及5种成分的含量测定 Δ

1
刘子祯 ，姜 蕊 ，许冬瑾（1.康美药业股份有限公司，广东 深圳 518000；2.保定市第一中心医院中药药剂
2 #
1＊
科，河北 保定 071000）
中图分类号 R286；R927.1 文献标志码 A 文章编号 1001-0408（2021）12-1453-07
DOI 10.6039/j.issn.1001-0408.2021.12.08

摘 要 目的：建立不同产地五味子制醋五味子配方颗粒的特征图谱，并测定其中5种成分的含量。方法：采用高效液相色谱法
（HPLC）。色谱柱为 Agilent ZORBAX SB-C18，流动相为乙腈-水（梯度洗脱），柱温为 30 ℃，流速为 1.0 mL/min，检测波长为 220
nm，进样量为10 µL。以五味子醇甲为参照，绘制19批醋五味子配方颗粒的HPLC特征图谱；采用《中药色谱指纹图谱相似度评价
系统（2012版）》进行相似度评价并确定共有峰；采用相同方法测定五味子醇甲、五味子醇乙、当归酰基戈米辛H、五味子甲素、五味
子乙素的含量。结果：19批醋五味子配方颗粒共有8个共有峰，相似度均在0.996以上；共指认五味子醇甲、为五味子醇乙、当归酰
基戈米辛H、五味子甲素、五味子乙素等5个共有峰。五味子醇甲、五味子醇乙、当归酰基戈米辛H、五味子甲素、五味子乙素检测
进样量的线性范围分别为 0.030～0.380、0.016～0.195、0.009～0.115、0.006～0.078、0.011～0.138 μg（r＞0.999）；精密度、稳定性
（24 h）、重复性试验的RSD均小于2％；平均加样回收率分别为99.84％、99.54％、99.28％、100.03％、100.27％（RSD小于1.4％，n＝
9）。19 批样品中上述 5 种成分的平均含量分别为 0.15％～0.36％、0.02％～0.16％、0.02％～0.06％、0.02％～0.08％、0.08％～
0.17％，其中河北产样品S18、S19中的5种成分总含量较高，S16、S17样品总含量较低，RSD为42％，其余样品（S1～S15）总含量的
RSD为12％，低于河北产，以吉林产样品含量较高。结论：所建特征图谱及含量测定方法的专属性强、重复性好，可用于评价醋五
味子配方颗粒的质量；辽宁、吉林、黑龙江等3省产五味子制醋五味子配方颗粒的总含量波动较河北省低，以吉林省产质量最佳。
关键词 醋五味子；配方颗粒；高效液相色谱法；特征图谱；含量测定

Establishment of Characteristic Pattern of Vinegar-processed Schisandra chinensis Formula Granules and
Content Determination of 5 Components
1
1
LIU Zizhen ，JIANG Rui ，XU Dongjin（1. Kangmei Pharmaceutical Co.，Ltd.，Guangdong Shenzhen 518000，
2
China；2. Dept. of TCM Pharmacy，Baoding First Central Hospital，Hebei Baoding 071000，China）
ABSTRACT OBJECTIVE：To establish characteristic pattern of vinegar-processed product of Schisandra chinensis formula
granules from different habitats，and to determine the contents of 5 components. METHODS：HPLC method was adopted. The
determination was performed on Agilent ZORBAX SB-C18 column with mobile phase consisted of acetonitrile-water （gradient
elution）at the flow rate of 1.0 mL/min. The column temperature was set at 30 ℃，and detection wavelength was set at 220 nm.
The sample size was 10 µL. Using schisandrin as reference，HPLC characteristic pattern of 19 batches of vinegar-processed
S. chinensis formula granules was drawn. The similarity evaluation was performed with Similarity Evaluation System of TCM
Chromatographic Fingerprints （2012 edition），and common peaks were confirmed. The contents of schisandrin，schisandrol，
angeloylgomisin H，schizandrin and deoxyschizandrin were determined by same method. RESULTS：There were 8 common peaks
in 19 batches of vinegar-processed S. chinensis formula granules，and the similarities were all above 0.996；five of them were
identified as schisandrin，schisandrol，angeloylgomisin H，schizandrin and deoxyschizandrin，respectively. The linear range of
schisandrin，schisandrol，angeloylgomisin H，schizandrin and deoxyschizandrin were 0.030-0.380，0.016-0.195，0.009-0.115，
0.006-0.078 and 0.011-0.138 μg（r＞0.999），respectively. RSDs of precision，stability（24 h）and reproducibility tests were all
lower than 2％. Average recoveries were 99.84％，99.54％，99.28％，100.03％，100.27％（RSD＜1.4％，n＝9）. Average contents
of five components in 19 batches of samples were in the range of 0.15％-0.36％，0.02％-0.16％，0.02％-0.06％，0.02％-0.08％
and 0.08％-0.17％，respectively；among them，total contents of five components in sample S18 and S19 from Hebei province were
relatively high，while those were relatively low in sample S16 and S17（RSD＝42％）；RSD of total content in other samples
（S1-S15）was 12％，and was lower than that of Hebei province；total content of five components were higher in sample from Jilin
province. CONCLUSIONS： Established characteristic pattern and method for the content determination are specific and
reproducible，and can be used for the quality evaluation of vinegar-processed S. chinensis formula granules. The total content
fluctuation of vinegar-processed product of S. chinensis formula granules from Liaoning，Jilin and Heilongjiang provinces is lower than
that in Hebei province，and the quality of vinegar-processed
Δ 基金项目：国家中药标准化项目（No.ZYB2H-Y-GD-13）
S. chinensis formula granules from Jilin province is the best.
＊ 主 管 中 药 师 ，硕 士 。 研 究 方 向 ：中 药 质 量 标 准 。 E-mail：
KEYWORDS Vinegar-processed Schisandra chinensis；
lzz332@126.com
# 通信作者：主管中药师，硕士。研究方向：中药合理用药。E- Formula granules； HPLC； Characteristic pattern； Content
mail：jiangrui54264@126.com determination

中国药房 2021年第32卷第12期 China Pharmacy 2021 Vol. 32 No. 12 ·1453 ·