医药导报
醫藥導報
의약도보
HERALD OF MEDICINE
2015年
6期
791-795
,共5页
巩伟%刘忠良%赵庆华%文凤娥%李鹏%张琨%赵梅
鞏偉%劉忠良%趙慶華%文鳳娥%李鵬%張琨%趙梅
공위%류충량%조경화%문봉아%리붕%장곤%조매
板蓝根颗粒%(R,S)-告依春%含量限度%色谱法,高效液相
闆藍根顆粒%(R,S)-告依春%含量限度%色譜法,高效液相
판람근과립%(R,S)-고의춘%함량한도%색보법,고효액상
Banlangen Granules%(R,S)-epigoitrin%Content limitation%Chromatography,high performance liquid
目的:建立高效液相色谱(HPLC)法测定板蓝根颗粒中(R,S)-告依春的含量并讨论含量限度。方法色谱柱为 SHIMADZU VP-ODS 柱(150 mm×4.6 mm,5μm),流动相为甲醇-0.02%磷酸溶液(7:93),流速1.0 mL·min-1,检测波长为245 nm,自动进样器进样,进样量10μL。分别依照转移率、测定结果统计数据讨论含量限度。结果(R, S)-告依春在0.0587~150.3495μg·mL-1质量浓度范围内线性关系良好(r=0.9997,n=7),低、中、高加入量平均回收率分别为98.72%,98.40%,98.60%,RSD 分别为1.84%,0.50%,1.82%。依照转移率、测定结果统计数据确定含量限度存在问题。结论该法操作方便、结果准确,精密度好,专属性强,可用于板蓝根颗粒的质量控制;(R,S)-告依春的含量限度应依据药动学和药效学数据确定。
目的:建立高效液相色譜(HPLC)法測定闆藍根顆粒中(R,S)-告依春的含量併討論含量限度。方法色譜柱為 SHIMADZU VP-ODS 柱(150 mm×4.6 mm,5μm),流動相為甲醇-0.02%燐痠溶液(7:93),流速1.0 mL·min-1,檢測波長為245 nm,自動進樣器進樣,進樣量10μL。分彆依照轉移率、測定結果統計數據討論含量限度。結果(R, S)-告依春在0.0587~150.3495μg·mL-1質量濃度範圍內線性關繫良好(r=0.9997,n=7),低、中、高加入量平均迴收率分彆為98.72%,98.40%,98.60%,RSD 分彆為1.84%,0.50%,1.82%。依照轉移率、測定結果統計數據確定含量限度存在問題。結論該法操作方便、結果準確,精密度好,專屬性彊,可用于闆藍根顆粒的質量控製;(R,S)-告依春的含量限度應依據藥動學和藥效學數據確定。
목적:건립고효액상색보(HPLC)법측정판람근과립중(R,S)-고의춘적함량병토론함량한도。방법색보주위 SHIMADZU VP-ODS 주(150 mm×4.6 mm,5μm),류동상위갑순-0.02%린산용액(7:93),류속1.0 mL·min-1,검측파장위245 nm,자동진양기진양,진양량10μL。분별의조전이솔、측정결과통계수거토론함량한도。결과(R, S)-고의춘재0.0587~150.3495μg·mL-1질량농도범위내선성관계량호(r=0.9997,n=7),저、중、고가입량평균회수솔분별위98.72%,98.40%,98.60%,RSD 분별위1.84%,0.50%,1.82%。의조전이솔、측정결과통계수거학정함량한도존재문제。결론해법조작방편、결과준학,정밀도호,전속성강,가용우판람근과립적질량공제;(R,S)-고의춘적함량한도응의거약동학화약효학수거학정。
Objective To establish HPLC method for determination of (R,S)-epigoitrin in Banlangen granules and discuss the content limitation. Methods The samples were separated on SHIMADZU VP-ODS (150 mm×4. 6 mm, 5 μm) and the mobile phase consisted of methol-0. 02% phosphoric acid solution (7:93) at a flow rate of 1. 0 mL. min-1 . The detection wavelength was set at 245 nm and the injection volume (in automatic sampler) was 10 μL. The content limitation was assessed according to the transfer rate and statistical data of the results. Results (R,S)-epigoitrin showed a good linear relationship at concentration of 0. 058 7 – 150. 349 5 μg·mL-1(r = 0. 999 7, n = 7). The average recovery rate was 98. 72% , 98. 40% and 98. 60% , respectively; RSD was 1. 84% , 0. 50% and 1. 82% , respectively. The content limitation of (R,S)-epigoitrin was unreasonable according to the transfer rate and the statistical data of the results. Conclusion The method is easy and simple to operate, accurate and stable in results, and highly specific, thus it is applicable for the quality control of Banlangen granules. The content limitation should be determined on the basis of pharmacokinetic and pharmacodynamic data.