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摘要： 目的 研究藤茶的药代分布情况及其与牛蒡子配伍的临床功效。方法 采用不同剂量喂养大鼠36天，末次给药1 h测量其心、肺、肝、脾、肾、心血组织样品中的二氢杨梅素含量;选取105例慢性咽炎人志愿受试者，随机分为试食组和对照组，分别为53例、52例，连续给药30天，观察试食前后的安全性和功效性指标，采用自身对照，组间对照统计分析。结果 大鼠各项组织中均未检出二氢杨梅素;临床试食未见明显不良反应，安全性指标正常，试食组临床症状及清咽体征有效率分别为62.05%、57.63%，高于对照组改善率，差异有统计学意义。结论 藤茶与牛蒡子配伍具有良好的清咽功效，且在该试验剂量下安全性高。
关键词：藤茶 ; 牛蒡子 ; 高效液相 ; 慢性咽炎
Abstract： Objective To study the Pharmacokinetics distribution of Ampelopsis grossedentata and the clinical efficacy of compatibility with Fructus arctiine. Methods The rats were fed with diffe-rent doses for 36 days， and the content of dihydromyricetin in the heart， lung， liver， spleen， kidney， heart and blood tissue samples was measured 1 hour after the last dose ; Choose 105 patients with chronic pharyngitis who are voluntarily tested， and randomly divide them into a test group with 53 cases and a control group with 52 cases. The drugs are continuously administered for 30 days. The safety and efficacy indicators of each group before and after the test are observed. Contrast statis-tical analysis.Results No residues of dihydromyricetin were detected in rat tissues ; There were no obvious adverse reactions in the clinic， and the safety indicators were normal. The effective rates of clinical symptoms and pharynx clearing signs in the test group were 62.05% and 57.63%， respectively， which were higher than the improvement rate in the control group， and the difference was statistically significant. Conclusion The compatibility of Ampelopsis grossedentata and Fructus arctiine has a good pharynx clearing effect， and the safety is high at this test dose.
Key words：Ampelopsis grossedentata ; Fructus arctiine ; HPLC ; Chronic pharyngitis
【中图分类号】R4 【文献标识码】A 【文章编号】1673-9026（2021）09-056-02
显齿蛇葡萄叶（Ampelopsis grossedentata），是葡萄科蛇葡萄属显齿蛇葡萄的茎叶，贵州等地多称作藤茶或霉茶。2013年显齿蛇葡萄叶被批准为新食品原料，藤茶具有清热降压，平肝利湿，活血通络的功效。藤茶中富含黄酮类化合物，其中二氢杨梅素（dihydromyricelin，DMY）高达18%以上，是其标志性成分。有许多试验研究发现藤茶和二氢杨梅素具有抗氧化、抗炎症、解酒醒酒、保肝、抗病原体、抗微生物、抗肿瘤及调血脂等多方面的药理作用[1-2]。苏东林等[3]利用二氢杨梅素对大鼠灌胃14天，实验毒性小，可耐受剂量为5 g/kg。钟正贤等[4]证明大鼠长期进食藤茶中总黄酮成分后未发现明显毒性，推段临床拟用剂量安全。欧贤红等[5]给予家兔口服二氢杨梅素，结果表明二氢杨梅素进入家兔体内后表现出吸收迅速、分布范围广泛、代谢速度快、半衰期短的特征。牛蒡子，药典载明其为菊科二年生草本植物牛蒡（Arctium lappa L.）的干燥成熟果实，药物功效包括疏散风热、宣肺祛痰、利咽透疹和解毒消肿[6-7]。本项目组通过研究藤茶中二氢杨梅素药代动力学分布特征及其与牛蒡子配伍的临床观察，充分研究该配伍的安全性及功效性。确保藤茶牛蒡子配伍用药安全的前提下，对后续清咽功能的保健食品开发提供了实验依据。
1 材料与方法
1.1 药材与试剂
藤茶（采购自贵州江口梵净山云峰野生植物开发有限公司，批号20180620）;牛蒡子（采购自安国市深豪药业有限公司，批号171101）;藤茶牛蒡子受试物（牛蒡子以生药量计，服用量约4 g/d）;藤茶牛蒡子浓缩液（藤茶牛蒡子受试物与无菌水按比例提取、浓缩，即得）;二氢杨梅素对照品（18031501，成都曼斯特生物科技有限公司）;二氢槲皮素对照品（AF20041364，成都埃法生物科技有限公司）;甲醇、磷酸、乙酸乙酯、醋酸、醋酸鈉、生理盐水等均购自北京化工厂。
关键词：藤茶 ; 牛蒡子 ; 高效液相 ; 慢性咽炎
Abstract： Objective To study the Pharmacokinetics distribution of Ampelopsis grossedentata and the clinical efficacy of compatibility with Fructus arctiine. Methods The rats were fed with diffe-rent doses for 36 days， and the content of dihydromyricetin in the heart， lung， liver， spleen， kidney， heart and blood tissue samples was measured 1 hour after the last dose ; Choose 105 patients with chronic pharyngitis who are voluntarily tested， and randomly divide them into a test group with 53 cases and a control group with 52 cases. The drugs are continuously administered for 30 days. The safety and efficacy indicators of each group before and after the test are observed. Contrast statis-tical analysis.Results No residues of dihydromyricetin were detected in rat tissues ; There were no obvious adverse reactions in the clinic， and the safety indicators were normal. The effective rates of clinical symptoms and pharynx clearing signs in the test group were 62.05% and 57.63%， respectively， which were higher than the improvement rate in the control group， and the difference was statistically significant. Conclusion The compatibility of Ampelopsis grossedentata and Fructus arctiine has a good pharynx clearing effect， and the safety is high at this test dose.
Key words：Ampelopsis grossedentata ; Fructus arctiine ; HPLC ; Chronic pharyngitis
【中图分类号】R4 【文献标识码】A 【文章编号】1673-9026（2021）09-056-02
显齿蛇葡萄叶（Ampelopsis grossedentata），是葡萄科蛇葡萄属显齿蛇葡萄的茎叶，贵州等地多称作藤茶或霉茶。2013年显齿蛇葡萄叶被批准为新食品原料，藤茶具有清热降压，平肝利湿，活血通络的功效。藤茶中富含黄酮类化合物，其中二氢杨梅素（dihydromyricelin，DMY）高达18%以上，是其标志性成分。有许多试验研究发现藤茶和二氢杨梅素具有抗氧化、抗炎症、解酒醒酒、保肝、抗病原体、抗微生物、抗肿瘤及调血脂等多方面的药理作用[1-2]。苏东林等[3]利用二氢杨梅素对大鼠灌胃14天，实验毒性小，可耐受剂量为5 g/kg。钟正贤等[4]证明大鼠长期进食藤茶中总黄酮成分后未发现明显毒性，推段临床拟用剂量安全。欧贤红等[5]给予家兔口服二氢杨梅素，结果表明二氢杨梅素进入家兔体内后表现出吸收迅速、分布范围广泛、代谢速度快、半衰期短的特征。牛蒡子，药典载明其为菊科二年生草本植物牛蒡（Arctium lappa L.）的干燥成熟果实，药物功效包括疏散风热、宣肺祛痰、利咽透疹和解毒消肿[6-7]。本项目组通过研究藤茶中二氢杨梅素药代动力学分布特征及其与牛蒡子配伍的临床观察，充分研究该配伍的安全性及功效性。确保藤茶牛蒡子配伍用药安全的前提下，对后续清咽功能的保健食品开发提供了实验依据。
1 材料与方法
1.1 药材与试剂
藤茶（采购自贵州江口梵净山云峰野生植物开发有限公司，批号20180620）;牛蒡子（采购自安国市深豪药业有限公司，批号171101）;藤茶牛蒡子受试物（牛蒡子以生药量计，服用量约4 g/d）;藤茶牛蒡子浓缩液（藤茶牛蒡子受试物与无菌水按比例提取、浓缩，即得）;二氢杨梅素对照品（18031501，成都曼斯特生物科技有限公司）;二氢槲皮素对照品（AF20041364，成都埃法生物科技有限公司）;甲醇、磷酸、乙酸乙酯、醋酸、醋酸鈉、生理盐水等均购自北京化工厂。