作者：伍利华, 钟林江, 杨俊莉, 张小雪, 马焓彬, 刘涛

作者单位：成都大学药学与生物工程学院, 四川 成都 610106

关键词：金莲花系列制剂;指纹图谱;抑菌活性;谱-效关系;再评价研究

摘要：

通过体外抑菌活性检测结合化学指纹图谱分析，对金莲花系列制剂4种剂型进行再评价。以药用生药量为指标，采用试管二倍稀释法测定金莲花系列制剂的最小抑菌生药量；采用高效液相色谱法建立金莲花系列制剂的指纹图谱；通过“中药色谱指纹图谱相似度评价系统（药典委员会2004A版）”对金莲花4种指纹图谱进行相似度分析；基于“Statistical Product and Service Solutions”软件，对抑菌活性值和色谱指纹图谱数据进行相关性分析，简述指纹图谱特征峰与抑菌作用的相关性。金莲花4种制剂指纹图谱相似度良好。金莲花口服液抑菌生药量最小，各成分相对峰面积与抑菌生药量相关性良好，峰1、3、4、5、6、7、8、9、11、12与生药量负相关，峰 2、13与生药量正相关。其中峰1、7、8、9、11对金黄色葡萄球菌抑菌生药量相关性与其他峰相比有显著性差异（P<0.05），峰3（P<0.05）、12（P<0.01）对大肠杆菌的抑菌生药量相关性有显著差异。结果表明金莲花口服液剂型质量较优，运用谱-效相关性分析能较好地对剂型进行再评价。

Study on the spectrum-effect relationship of Jinlianhua series preparations based on in vitro bacteriostasis
WU Lihua, ZHONG Linjiang, YANG Junli, ZHANG Xiaoxue, MA Hanbin, LIU Tao
School of Pharmacy and Bioengineering, Chengdu University, Chengdu 610106, China
Abstract: Four dosage forms of trollflower series preparations were reevaluated by in vitro antibacterial activity detection and chemical fingerprint analysis. The minimal antimicrobial dosage of trollflower series preparations was determined by tube double dilution method with medicinal crude drug as index. HPLC was used to establish the fingerprint of trollflower series preparations. The similarity of four fingerprints of trollflower was analyzed through the "similarity evaluation system of chromatographic fingerprint of traditional Chinese medicine (pharmacopoeia committee 2004A edition)". Based on statistical product and service solutions software, correlation analysis was carried out between antibacterial activity value and chromatographic fingerprint data, the correlation between fingerprint characteristic peak and bacteriostasis was briefly described. Fingerprints of four preparations of trollflower have good similarity. The relative peak area of each component with the smallest bacteriostatic crude drug of trollflower oral liquid has a good correlation with the bacteriostatic crude drug. Peak 1, 3, 4, 5, 6, 7, 8, 9, 11, 12 is negatively correlated with the crude drug dosage. Peak 2, 13 is positively correlated with the crude drug dosage. Among them, peak 1, 7, 8, 9, 11 showed significant difference in the correlation between antibacterial and antibiotic doses to Staphylococcus aureus (P<0.05) compared to other peaks, Peak 3 (P<0.05) and Peak 12 (P<0.01) have significant differences in the correlation of antimicrobial and antibiotic doses to E. coli. The quality of Jinlianhua oral liquid is better. Spectrum-effect correlation analysis can be used to re-evaluate the dosage form better.
Keywords: trollflower series preparations;fingerprints;antimicrobial activity;spectrum-effect relationship;re-evaluation study
2019, 45(11):51-56  收稿日期: 2019-02-25;收到修改稿日期: 2019-04-29
基金项目: 四川省科技厅2018年科技项目（2018ZR0107，2018TJPT0049）
作者简介: 伍利华(1990-),女,四川资阳市人,助理工程师,硕士,从事中成药再评价及中药资源综合利用研究
参考文献
[1] 刘涛, 郭晓恒, 万德光, 等. 基于中成药工艺与质量控制的再评价模式商建[J]. 中草药, 2011, 42(10):1873-1877
[2] 秦昆明, 郑礼娟, 沈保家, 等. 谱效关系在中药研究中的应用及相关思考[J]. 中国中药杂志, 2013, 38(1):26-31
[3] 雷蓉, 冯丽, 刘永利, 等.金莲花的研究进展[J].中药材, 2015, 38(5):1085-1091.
[4] 刘静, 刘建中, 郭金甲, 等. 金莲花片治疗上呼吸道感染临床观察[J]. 湖北中医杂志, 2007(10):29
[5] 李勇军, 蒋礼, 何燕玲, 等. 金莲花胶囊高效液相色谱指纹图谱研究[J]. 中国药业, 2018, 27(2):23-25
[6] 任桂玲, 郭艳玲, 董晓强, 等. 金莲花口服液HPLC指纹图谱及有效成分含量测定[J]. 承德医学院学报, 2014, 31(6):463-465
[7] 万思琦, 刘立雅, 刘梦思, 等. 荭草苷药理作用机制研究[J]. 医学研究杂志, 2018, 47(6):183-186
[8] 潘杰, 刘德胜, 颜贵明. 数据分析应用于中药谱效关系中的研究进展[J]. 中医药学报, 2018, 46(4):119-122
[9] 李力, 潘倩雯, 刘宏. 灰色关联度分析法在中药谱效学研究中的应用[J]. 中国药房, 2018, 29(11):1581-1584
[10] 颜娟, 郑茂东, 崔玉环. 牡荆苷的药理作用研究进展[J]. 山东医药, 2017, 57(17):110-112
[11] 姚兰, 焦安妮, 冯琳琳, 等. 大叶冬青药材的黄嘌呤氧化酶抑制作用的谱效关系研究[J]. 中草药, 2018(20):4838-4843
[12] 徐玉玲, 贺桢翔, 刘钱, 等. 基于纤维蛋白原活性的红花注射液抗凝血谱-效关系研究[J]. 中国测试, 2019, 45(2):59-63
[13] 刘涛, 冯晶晶, 李鹏程, 等. 元胡止痛系列制剂4种工艺比较[J]. 中成药, 2017, 39(4):851-854