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心痛舒喷雾剂 HPLC 指纹图谱、含量测定及指标成分传递规律
研究 Δ
梁万徽 ,陶舒悦 ,左池靖 ,汪 杰 ,刘 艳 ,余卫东 ,彭 灿 1, 2, 3, 4, 5 # ,王 茜 (1.安徽中医药大学药学院,
1*
1
1
1
1, 5
1
1
合肥 230012;2.省部共建安徽道地中药材品质提升协同创新中心,合肥 230012;3.安徽省乡村振兴协同技
术服务中心,合肥 230012;4.安徽省现代中药产业共性技术研究中心,合肥 230012;5.药物制剂技术与应用
安徽省重点实验室,合肥 230012)
中图分类号 R917 文献标志码 A 文章编号 1001-0408(2023)23-2861-07
DOI 10.6039/j.issn.1001-0408.2023.23.08
摘 要 目的 建立心痛舒喷雾剂高效液相色谱(HPLC)指纹图谱,对其指认成分进行含量测定,并探究饮片、中间体、喷雾剂中指
标成分的传递规律,为心痛舒喷雾剂的工艺把关和质量控制提供参考。方法 采用《中药色谱指纹图谱相似度评价系统(2012
版)》建立13批心痛舒喷雾剂的HPLC指纹图谱,并指认共有峰;采用HPLC法对指认成分进行含量测定;以牡丹皮中的丹皮酚和
川芎中的阿魏酸为指标成分,考察两者在饮片、中间体、喷雾剂中的传递规律。结果 13批心痛舒喷雾剂中共有33个共有峰,相似
度均≥0.994;共指认了8个成分,分别为没食子酸(5号峰)、氧化芍药苷(9号峰)、绿原酸(10号峰)、咖啡酸(14号峰)、芍药苷(17
号峰)、阿魏酸(21号峰)、洋川芎内酯Ⅰ(27号峰)、丹皮酚(31号峰)。8个成分的含量分别为0.590 3~0.719 7、0.565 7~0.851 3、
0.279 4~0.368 1、0.080 6~0.106 1、1.922 5~3.033 5、0.151 3~0.191 6、0.250 6~0.336 0、3.056 7~4.161 0 mg/mL。丹皮酚和阿魏
酸从饮片→喷雾剂的平均转移率分别为63.76%、38.06%,其中在牡丹皮的渗漉提取和减压浓缩工艺中丹皮酚的损失超30%,在川
芎的水蒸气蒸馏提取工艺中阿魏酸的损失超50%。结论 建立的心痛舒喷雾剂HPLC指纹图谱及含量测定方法重复性好、专属性
强;牡丹皮的渗漉提取和减压浓缩及川芎的水蒸气蒸馏提取是引起指标成分转移率下降的关键工艺。
关键词 心痛舒喷雾剂;高效液相色谱法;指纹图谱;含量测定;成分传递规律
HPLC fingerprint, content determination and transferring patterns of index components of Xintongshu
spray
1
1
LIANG Wanhui ,TAO Shuyue ,ZUO Chijing ,WANG Jie ,LIU Yan ,YU Weidong ,PENG Can 1, 2, 3, 4, 5 ,WANG
1
1
1
1
Qian (1. School of Pharmacy, Anhui University of Chinese Medicine, Hefei 230012, China;2. MOE-Anhui
1, 5
Joint Collaborative Innovation Center for Quality Improvement of Anhui Genuine Chinese Medicinal Materials,
Hefei 230012, China;3. Rural Revitalization Collaborative Technical Service Center of Anhui Province, Hefei
230012, China;4. Generic Technology Research Center for Anhui TCM Industry, Hefei 230012, China;
5. Anhui Provincial Key Laboratory of Pharmaceutical Preparation Technology and Application, Hefei 230012,
China)
ABSTRACT OBJECTIVE To establish the HPLC fingerprint of Xintongshu spray, determine the contents of identified
components, and investigate the transferring patterns of the index components of decoction pieces, intermediates and spray, so as
to provide scientific reference for technology management and quality control of Xintongshu spray. METHODS HPLC fingerprints
of 13 batches of Xintongshu spray were established by the Similarity Evaluation System for Chromatographic Fingerprints of TCM
(2012 edition), and common peaks were identified; the contents of identified components were determined by HPLC. The paeonol
in Moutan Cortex and ferulic acid in Chuanxiong Rhizoma were used as index components to investigate the transferring patterns of
them in decoction pieces, intermediates and spray. RESULTS
Δ 基金项目 安徽省科技重大专项(No.202103a07020001);亳州市 There were a total of 33 common peaks in the fingerprints of
科技重大专项揭榜挂帅项目(No.bzzd2021002) 13 batches of Xintongshu spray, and the similarities were
*第一作者 硕士研究生。研究方向:中药复方药效物质基础。
more than 0.994. Eight components were identified, i.e. gallic
E-mail:1551457923@qq.com
# 通信作者 副教授,硕士生导师,博士。研究方向:中药制剂与分 acid (peak 5), oxypaeoniflorin (peak 9), chlorogenic acid
析。E-mail:pengcanking@hotmail.com (peak 10), caffeic acid (peak 14), paeoniflorin (peak 17),
中国药房 2023年第34卷第23期 China Pharmacy 2023 Vol. 34 No. 23 · 2861 ·