中成药
中成藥
중성약
CHINESE TRADITIONAL PATENT MEDICINE
2010年
3期
356-359
,共4页
山庄降脂片%指纹图谱%橙黄决明素%高效液相色谱法
山莊降脂片%指紋圖譜%橙黃決明素%高效液相色譜法
산장강지편%지문도보%등황결명소%고효액상색보법
Shanzhuang Jiangzhi Tablet%HPLC%fingerprint%quality control
目的:建立山庄降脂片(决明子,山楂,荷叶)的指纹图谱检测标准,为中成药产品及生产工艺过程质量控制提供有效的方法.方法:采用Diamonsil~(TM) C_(18)(150 mm×4.6 mm,5 μm)色谱柱;B相为甲醇,D相为0.1%磷酸组成的梯度洗脱液;柱温30℃;流速1.0 mL/min;检测波长254 nm;分析时间:55 min.结果:对10批山庄降脂片样品进行了HPLC分析,建立了该制剂含17个共有峰的指纹图谱.结论:该方法稳定可靠,可以有效地用于山庄降脂片生产过程的质量控制和产品的质量评价.
目的:建立山莊降脂片(決明子,山楂,荷葉)的指紋圖譜檢測標準,為中成藥產品及生產工藝過程質量控製提供有效的方法.方法:採用Diamonsil~(TM) C_(18)(150 mm×4.6 mm,5 μm)色譜柱;B相為甲醇,D相為0.1%燐痠組成的梯度洗脫液;柱溫30℃;流速1.0 mL/min;檢測波長254 nm;分析時間:55 min.結果:對10批山莊降脂片樣品進行瞭HPLC分析,建立瞭該製劑含17箇共有峰的指紋圖譜.結論:該方法穩定可靠,可以有效地用于山莊降脂片生產過程的質量控製和產品的質量評價.
목적:건립산장강지편(결명자,산사,하협)적지문도보검측표준,위중성약산품급생산공예과정질량공제제공유효적방법.방법:채용Diamonsil~(TM) C_(18)(150 mm×4.6 mm,5 μm)색보주;B상위갑순,D상위0.1%린산조성적제도세탈액;주온30℃;류속1.0 mL/min;검측파장254 nm;분석시간:55 min.결과:대10비산장강지편양품진행료HPLC분석,건립료해제제함17개공유봉적지문도보.결론:해방법은정가고,가이유효지용우산장강지편생산과정적질량공제화산품적질량평개.
AIM:To establish an effective and convenient method for applying HPLC fingerprints to quality control in the production of Shanzhuang Jiangzhi Tablet(Semen cassiae,Fructus crataegi,and Folium nelumbinis).METHODS:Diamonsil~(TM) C_(18)(150 mm×4.6 mm,5 μm)analytical column was used and eluted with a gradient program consisted of phase B(methanol)and phase D(1 % phosphoric acid)and detected at 254 nm;the column temperature was 30℃.The flow rate was 1.0 mL/min.RESULTS:Ten batches of sample tablets were tested and gained HPLC fingerprint of the tablet containing 17 common peaks.CONCLUSION:This validated method is available for quality evaluation and quality control in Shanzhuang Jiangzhi Tablet.
