乌天麻多酚口服液的制备、质量评价及药效学研究

Study on the preparation,quality control and pharmacodynamics of Gastrodia elata f.glauca oral liquid

目的制备乌天麻多酚口服液,进行体外质量评价并考察其防治偏头痛的疗效。方法考察乌天麻多酚口服液的制备工艺,并对制备的样品进行质量评价;比较4个不同产地乌天麻所制备口服液的指纹图谱的相似度。将SD大鼠随机分为正常组、模型组、阳性组、天麻素组和乌天麻口服液组(135、270、540 mg·kg^(-1)),于给药第6、14天皮下注射硝酸甘油致大鼠偏头痛,观察其行为学,第14天造模3 h后采集血浆并处死大鼠,收取脑组织用于生化和病理检测。结果乌天麻多酚口服液的制备方法可行,口服液的质量符合《中国药典》中的相关要求;口服液中天麻素、对羟基苯甲醇和巴利森苷A、B、C、E等6种成分的含量分别为2.72±0.03、2.07±0.04、10.30±0.06、5.76±0.26、1.07±0.05、6.75±0.13 mg·mL^(-1);贵州普安、湖北随州、四川乐山、云南昭通产乌天麻所制备口服液的指纹图谱的相似度均大于0.85,成分含量较为均一。乌天麻多酚口服液可缓解大鼠的偏头痛,调节血浆中一氧化氮、CGRP和脑干5-羟色胺的水平,并改善脑区病理损伤。结论所建乌天麻多酚口服液的制备工艺可重复,质量可靠。制备的乌天麻多酚口服液具有显著地缓解偏头痛的作用。

OBJECTIVE To prepare the oral liquid of Gastrodia elata Bl.f.glauca S.Chow(G.elata f.glauca)polyphenol,to evaluate its quality in vitro,and to investigate its efficacy in the prevention and treatment of migraine.METHODS The preparation process of G elata f.glauca polyphenol oral liquid was investigated,and the quality of oral liquid was evaluated.The similarity of fingerprint spectra of oral liquid prepared from four dfferent regions of G.elata f.glauca were compared.The SD rats were randomly divided into the blank control group,model group,positive group,gastrodin group,low dose,middle dose and high dose(135.0,270.0,540.0 mg·kg-')of oral liquid group.The rate model of migraine was induced by subcutaneous injection of nitroglycerin on the 6th and 14th day of administration,then the behavior of rats was observed.On the 14th day,after modeling for 3 hours,plasma samples were collected,and brain tissue was collected for biochemical and pathological detection.RESULTS The preparation method of G.elata f.glauca polyphenol oral liquid was feasible.The quality of oral liquid met the relevant requirements of the Chinese Pharmacopoeia.The contents of gastrodin,p-hydroxy benzyl alcohol and parishin A,B,C and E in the oral liquid were 2.72±0.03,2.07±0.04,10.30±0.06,5.76±0.26,1.07±0.05 and 6.75±0.13 mg·kg^(-1),respectively.The fingerprint similarity of the oral liquid prepared from G.elata f.glauca from four producing areas,namely Pu'an Guizhou,Suizhou,Hubei,Leshan,Sichuan,and Zhaotong,Yunnan,was greater than O.85,and the content of the components was relatively uniform.The G.elata f.glauca polyphenol oral liquid could alleviated migraine behavior in rats,regulated plasma NO,CGRP,and brainstem 5-HT levels,and ameliorated brain pathological damage.CONCLUSION The established preparation process of G.elata f.glauca polyphenol oral liquid is repeatable,with reliable quality.The prepared G.elataf.glauca polyphenol oral liquid has a significant relieving effect on migraine.