李江 陈凌云 付鹏 余晓玲

摘要：目的建立復方臭灵丹合剂的质量标准。方法采用TLC对桔梗和鱼腥草进行定性鉴别，依据《云南省中药材（民族药材）质量标准研究技术指导原则（试行）》对其进行分析方法验证及重现性考察。采用HPLC对合剂中的洋艾素和金丝桃苷进行定量分析，同时进行相关方法学的考察。结果桔梗和鱼腥草TLC鉴别色谱图中，供试品与对照药材相应位置上均显相同颜色的特征斑点，阴性无干扰，且分析方法验证与重现性考察均合格。洋艾素和金丝桃苷分别在2.59～55.47 μg/mL和4.02～51.68 μg/mL范围内线性关系良好，回归方程分别为Y1=43.24X-12.39（R=0.999 6）和Y2=63.82X-30.04（R=0.999 4），准确度试验中，平均加样回收率分别为100.06%和100.14%，RSD值分别为2.36%和2.74%（n=9），其余方法学考察均合格，洋艾素和金丝桃苷的平均含量分别为2.41 μg/mL和9.95 μg/mL。结论建立的质量标准稳定可行。

关键词：复方臭灵丹合剂;桔梗;鱼腥草;洋艾素;金丝桃苷;质量标准

中图分类号：R285.5文献标志码：A文章编号：1007-2349（2021）02-0058-06

Study on the Quality Standard of Compound Laggera Pterodonta Mixture

LI Jiang1， FU Peng1， CHEN Ling-yun1，2， YU Xiao-ling1， 3

（1. Yunnan University of Traditional Chinese Medicine， Kunming 650500， China;

2. Key Laboratory of External Drug Delivery System and Preparation Technology Research in Universities

of Yunnan Province， Kunming 650500， China;

3. Traditional Chinese Medicine Hospital of Kunming City， Kunming 650011， China）

【Abstract】Objective： To establish the quality standard of Compound Laggera Pterodonta Mixture. Methods： TLC was used to qualitatively identify Platycodon grandiflorum and Houttuynia cordata. According to the "Technical Guidelines for Research on Quality Standards of Chinese Medicinal Materials （Ethnic Medicinal Materials） in Yunnan Province （Trial）"， the analytical methods were verified and reproducible. HPLC was used to quantitatively analyze the artemitin and hyperoside in the mixture， and the related methodology was investigated at the same time. Results： In the TLC identification chromatogram of Platycodon grandiflorum and Houttuynia cordata， the test product and the control medicinal material showed the characteristic spots of the same color on the corresponding positions， negative and no interference. The analytical method verification and reproducibility inspection were all qualified. Artemitin and hyperoside had a good linear relationship in the range of 2.59 to 55.47μg/mL and 4.02 to 51.68μg/mL， respectively. The regression equations were Y1=43.24X-12.39 （R=0.999 6） and Y2=63.82X-30.04 （R=0.9994）， respectively. In the accuracy test， the average sample recovery rates were 100.06% and 100.14%， respectively and the RSD values were 2.36% and 2.74% （n=9）， respectively. The other methodological investigations were qualified. The average contents of artemitin and hyperoside were 2.41 μg/mL and 9.95 μg/mL， respectively. Conclusion： The established quality standards are stable and feasible.

【Key words】Compound Laggera Pterodonta Mixture;Platycodon grandiflorum;Houttuynia cordata;Artemitin;Hyperoside;Quality standard

上呼吸道感染是以咳嗽、咽痛及发热等为主要症状，与细菌或病毒感染有关的疾病[1]，其发病机制与气道广泛炎症、气道的上皮细胞损伤、气道高反应性、气道神经炎症、β肾上腺素能受体功能的改变、M胆碱能受体功能的改变等有关，并通过炎症细胞、细胞因子、炎症介质、神经递质、神经肽、免疫球蛋白等起作用[2]，其治疗药物以抗病毒及抗生素类药物为主[3]。

复方臭灵丹合剂中臭灵丹为君药主要含洋艾素、金腰乙素、槲皮素等黄酮类成分[4]，具有清热解毒的功效，常用于治疗上呼吸道感染[5]，鱼腥药中金丝桃苷具有抑菌抗菌的作用[6]，西青果主要含多酚，类黄酮类成分，具有抗炎，抗菌作用[7]，其余滇柴胡、桔梗等药味对此过程亦有抑制作用[8-9]。……