中国医院用药评价与分析
中國醫院用藥評價與分析
중국의원용약평개여분석
Evaluation and Analysis of Drug-Use in Hospitals of China
2015年
10期
1316-1319
,共4页
腹可安片%质量标准%研究%东莨菪内酯%没食子酸
腹可安片%質量標準%研究%東莨菪內酯%沒食子痠
복가안편%질량표준%연구%동랑탕내지%몰식자산
Fuke'an pills%Quality standard%Studies%Scopoletin%Gallic acid
目的：采用高效液相色谱法测定东莨菪内酯、没食子酸的含量，建立腹可安片质量标准，以控制产品质量。方法：通过薄层色谱法对扭肚藤、车前草、石榴皮、火炭母进行薄层鉴别。东莨菪内酯使用C18色谱柱；乙腈-水-冰醋酸（V∶V∶V＝13∶87∶1）为流动相，检测波长为345 nm；没食子酸使用C18色谱柱，以甲醇-0.5％冰醋酸（V∶V＝7∶93）为流动相，检测波长为270 nm。结果：薄层鉴别中东莨菪内酯和没食子酸得到很好的分离，当东莨菪内酯在3.44～41.28μg／ml浓度范围内呈线性关系（ r＝0.9999，n＝5），加样回收率为（100.6±1.07）％（n＝9）；当没食子酸在10.52～63.12μg／ml浓度范围内呈线性关系（r＝0.99993，n＝6），加样回收率为（99.73±0.52）％（n＝9）。结论：本法简便、准确、可靠、专属性强、重现性好，可作为腹可安片的质量标准。
目的：採用高效液相色譜法測定東莨菪內酯、沒食子痠的含量，建立腹可安片質量標準，以控製產品質量。方法：通過薄層色譜法對扭肚籐、車前草、石榴皮、火炭母進行薄層鑒彆。東莨菪內酯使用C18色譜柱；乙腈-水-冰醋痠（V∶V∶V＝13∶87∶1）為流動相，檢測波長為345 nm；沒食子痠使用C18色譜柱，以甲醇-0.5％冰醋痠（V∶V＝7∶93）為流動相，檢測波長為270 nm。結果：薄層鑒彆中東莨菪內酯和沒食子痠得到很好的分離，噹東莨菪內酯在3.44～41.28μg／ml濃度範圍內呈線性關繫（ r＝0.9999，n＝5），加樣迴收率為（100.6±1.07）％（n＝9）；噹沒食子痠在10.52～63.12μg／ml濃度範圍內呈線性關繫（r＝0.99993，n＝6），加樣迴收率為（99.73±0.52）％（n＝9）。結論：本法簡便、準確、可靠、專屬性彊、重現性好，可作為腹可安片的質量標準。
목적：채용고효액상색보법측정동랑탕내지、몰식자산적함량，건립복가안편질량표준，이공제산품질량。방법：통과박층색보법대뉴두등、차전초、석류피、화탄모진행박층감별。동랑탕내지사용C18색보주；을정-수-빙작산（V∶V∶V＝13∶87∶1）위류동상，검측파장위345 nm；몰식자산사용C18색보주，이갑순-0.5％빙작산（V∶V＝7∶93）위류동상，검측파장위270 nm。결과：박층감별중동랑탕내지화몰식자산득도흔호적분리，당동랑탕내지재3.44～41.28μg／ml농도범위내정선성관계（ r＝0.9999，n＝5），가양회수솔위（100.6±1.07）％（n＝9）；당몰식자산재10.52～63.12μg／ml농도범위내정선성관계（r＝0.99993，n＝6），가양회수솔위（99.73±0.52）％（n＝9）。결론：본법간편、준학、가고、전속성강、중현성호，가작위복가안편적질량표준。
OBJECTIVE:The HPLC method was adopted to determined the content of scopoletin and gallic acid, the method for the quality control of Fuke'an pills was developed, so as to control the product quality.METHODS:The thin-layer of Jasminum elongatum, Plantago asiatica L., Pericarpium granati and Chinese knotweed herb were determined by TLC.The scopoletin used C18 column, acetonitrile-water-ice-acetid acid (V∶V∶V=13∶87∶1) was set as mobile phase, and the wavelength of detector was set at 345 nm.The gallic acid used C18 column, methanol-0.5%ice -acetid acid ( V∶V=7∶93) was set as mobile phase, and the wavelength of detector was set at 270 nm. RESULTS:Scopoletin and gallic acid had been separated well in the thin-layer identification.When the line range of scopoletin was 3.44 μg/ml~41.28 μg/ml (r=0.999 9,n=5), the average recovery was [(100.6 ±1.07)%(n=9)].When the line range of gallic acid was 10.52μg/ml~63.12μg/m (r=0.999 93,n=5), the average recovery was [ (99.73 ±0.52%) ( n=9 ) ] .CONCLUSIONS: The method is simple, accurate, reliable with good specificity and reproducibility, it can be used as the quality standard of Fuke'an pills.
