中国药品标准
中國藥品標準
중국약품표준
DRUG STANDARDS OF CHINA
2014年
6期
433-437
,共5页
王青晓%刘瑞新%高晓洁%王海波%李振国
王青曉%劉瑞新%高曉潔%王海波%李振國
왕청효%류서신%고효길%왕해파%리진국
香砂养胃片%质量控制%薄层色谱%高效液相色谱%改进
香砂養胃片%質量控製%薄層色譜%高效液相色譜%改進
향사양위편%질량공제%박층색보%고효액상색보%개진
Xiangsha Yangwei Tablets%quality control%TLC%HPLC%improvement
目的:改进并提高香砂养胃片的质量标准。方法:针对原标准存在的部分方法操作繁琐或专属性不强、缺少主要药味的〔鉴别〕或〔含量测定〕项目等问题,改进并提高其质量标准。结果:改进后的TLC鉴别方法专属性强且效率更高,用两个薄层色谱图即能鉴别苍术、广藿香、陈皮、厚朴、木香5种药材;试验发现原标准中豆蔻的TLC鉴别有明显的阴性干扰,应予删除;采用正交试验优化建立了陈皮中橙皮苷的HPLC含量测定方法;将原有的厚朴酚单指标HPLC质控方法改为测定厚朴酚、和厚朴酚双指标。结论:改进提高后的方法简便、快速、准确,能够更有效地控制香砂养胃片的质量。
目的:改進併提高香砂養胃片的質量標準。方法:針對原標準存在的部分方法操作繁瑣或專屬性不彊、缺少主要藥味的〔鑒彆〕或〔含量測定〕項目等問題,改進併提高其質量標準。結果:改進後的TLC鑒彆方法專屬性彊且效率更高,用兩箇薄層色譜圖即能鑒彆蒼術、廣藿香、陳皮、厚樸、木香5種藥材;試驗髮現原標準中豆蔻的TLC鑒彆有明顯的陰性榦擾,應予刪除;採用正交試驗優化建立瞭陳皮中橙皮苷的HPLC含量測定方法;將原有的厚樸酚單指標HPLC質控方法改為測定厚樸酚、和厚樸酚雙指標。結論:改進提高後的方法簡便、快速、準確,能夠更有效地控製香砂養胃片的質量。
목적:개진병제고향사양위편적질량표준。방법:침대원표준존재적부분방법조작번쇄혹전속성불강、결소주요약미적〔감별〕혹〔함량측정〕항목등문제,개진병제고기질량표준。결과:개진후적TLC감별방법전속성강차효솔경고,용량개박층색보도즉능감별창술、엄곽향、진피、후박、목향5충약재;시험발현원표준중두구적TLC감별유명현적음성간우,응여산제;채용정교시험우화건립료진피중등피감적HPLC함량측정방법;장원유적후박분단지표HPLC질공방법개위측정후박분、화후박분쌍지표。결론:개진제고후적방법간편、쾌속、준학,능구경유효지공제향사양위편적질량。
Objective:To improve the quality standard of Xiangsha Yangwei Tablets.Methods:Aiming at the problems existing in o-riginal standard, such as the complicated operation or weak specificity in some methods, the lack of identification or content determina-tion of main medicinal herbs, the quality standard of Xiangsha Yangwei Tablets had been improved.Results:The improved TLC meth-ods were specific and efficient, with two TLC systems, Atractylodes rhizome, Pogostemonis herbs, Citri reticulatae pericarpium, Mag-nolia officinalis and Aucklandiae radix, five kinds of medicinal herbs could be distinguished;the TLC identification of Amomi fructus rotundus had obvious negative interference, should be deleted.A HPLC detemination method of hesperidin in Citri reticulatae peri-carpium was optimized and established by orthogonal test;modified single index of magnolol in original HPLC method to two of magnol-ol and honokiol.Conclusion:The improved method is simple, fast and accurate compared to the original method, which could be bet-ter for quality control of Xiangsha Yangwei Tablets.