湿生扁蕾质量标准的提升研究  

Study on the upgrade of quality standard for Gentianopsis paludosae Herb

作　　者：次旦多吉 旺杰次仁 达娃卓玛 阳勇[2] 秦伟瀚[2] CIDAN Duoji;WANGJIE Ciren;DAWA Zhuoma;YANG Yong;QIN Weihan(NMPA Key Laboratory of Quality Evaluation Research in Traditional Chinese Medicine(Tibetan Medicine),Tibet Food and Drug Inspection and Research Institute,Lhasa,Tibet,850000 P.R.China;Chongqing Academy of Chinese Materia Medica,Chongqing,400065 P.R.China)

机构地区：[1]西藏自治区食品药品检验研究院国家药品监督管理局中药(藏药)质量控制重点实验室,西藏拉萨850000 [2]重庆市中药研究院,重庆400065

出　　处：《华西药学杂志》2023年第5期537-541,共5页West China Journal of Pharmaceutical Sciences

摘　　要：目的 修订提高藏药湿生扁蕾的质量标准。方法 按2020年版《中国药典》中四部通用检测方法,测定湿生扁蕾的水分含量;采用TLC法,以三氯甲烷-甲醇-甲酸(20:1:0.2)为展开剂,定性鉴别湿生扁蕾;采用HPLC法,以甲醇-0.4%甲酸为流动相,在254 nm处定量检测獐牙菜苷和木犀草素的含量。结果 湿生扁蕾的水分含量为8.07%~9.95%、浸出物为15.82%~30.81%;9~588μg·mL-1獐牙菜苷、8~493μg·mL-1木犀草素与峰面积积分的线性关系良好(r分别为0.9999、0.9998);獐牙菜苷、木犀草素的平均回收率分别为100.52%、100.79%;湿生扁蕾药材中獐牙菜苷、木犀草素的含量分别为0.57%~1.94%、0.14%~0.54%。结论 所制定的湿生扁蕾质量标准准确、可靠,能够控制湿生扁蕾的质量。OBJECTIVE To revise and improve the quality standard of Tibetan medicine Gentianopsis paludosae Herb(GPH).METHODS The moisture content of GPH was determined with reference to the four general detection methods of Chinese Pharmacopoeia 2020 edition.TLC method was used to qualitatively identify GPH with chloroform-methanol-formic acid(20∶1∶0.2)as the developing agent.The content of sweroside and luteolin was quantitatively detected by HPLC with methanol:0.4%formic acid as mobile phase at a wavelength of 254 nm.RESULTS The moisture content of GPH was between 8.07%and 9.95%,the extract was between 15.82%and 30.81%.The linear relationship between sweroside and chromatographic peak area was good within the range of 9-588μg·mL-1(r=0.9999),the luteolin was within the range of 8-493μg·mL-1(r=0.9998)and the chromatographic peak area integral value was in a good linear relationship.The average recoveries of sweroside and luteolin were 100.52%and 100.79%.The contents of sweroside and luteolin in the medicinal materials of GPH were between 0.57%-1.94%and 0.14%-0.54%,respectively.CONCLUSION The quality standard of GPH formulated in this experiment is accurate and reliable,and can control the quality of GPH.

关 键 词：藏药材 湿生扁蕾 质量标准 质量控制 獐牙菜苷 木犀草素 鉴别 浸出物 水分 含量测定 

分 类 号：R917[医药卫生—药物分析学]