医药导报
醫藥導報
의약도보
HERALD OF MEDICINE
2014年
12期
1627-1630
,共4页
四味清口含片%桂皮醛%橙皮苷%色谱法,高效液相%含量测定
四味清口含片%桂皮醛%橙皮苷%色譜法,高效液相%含量測定
사미청구함편%계피철%등피감%색보법,고효액상%함량측정
Siweiqing buccal tablets%HesPeridin%Cinnamaldehyde%ChromatograPhy,high Performance liquid%Content determination
目的：建立同时测定四味清口含片中桂皮醛和橙皮苷含量的方法。方法采用高效液相色谱法( HPLC)：色谱条件为Inertsil ODS_SP(4.6 mm×150 mm,5μm)色谱柱分离,检测波长为290 nm,流动相为乙腈-水进行梯度洗脱,流速为1.0 mL·min-1,柱温为30℃,理论板数不低于3000。结果桂皮醛进样量在0.025~0.500μg,橙皮苷进样量在0.10~2.00μg范围内与峰面积积分值线性关系均良好；在精密度实验、稳定性实验、重复性实验中,桂皮醛和橙皮苷峰面积的相对标准偏差(RSD)分别为1.16%和1.03%,1.27%和1.08%,1.23%和1.28%；桂皮醛的平均加样回收率为99.24%,RSD为1.65%(n=9),橙皮苷的平均加样回收率为99.39%,RSD为1.85%(n=9)。结论该方法具有良好的专属性和重复性,加样回收率实验符合要求,能准确、稳定地对四味清口含片中桂皮醛和橙皮苷含量进行定量测定,可作为该制剂的质量控制方法。
目的：建立同時測定四味清口含片中桂皮醛和橙皮苷含量的方法。方法採用高效液相色譜法( HPLC)：色譜條件為Inertsil ODS_SP(4.6 mm×150 mm,5μm)色譜柱分離,檢測波長為290 nm,流動相為乙腈-水進行梯度洗脫,流速為1.0 mL·min-1,柱溫為30℃,理論闆數不低于3000。結果桂皮醛進樣量在0.025~0.500μg,橙皮苷進樣量在0.10~2.00μg範圍內與峰麵積積分值線性關繫均良好；在精密度實驗、穩定性實驗、重複性實驗中,桂皮醛和橙皮苷峰麵積的相對標準偏差(RSD)分彆為1.16%和1.03%,1.27%和1.08%,1.23%和1.28%；桂皮醛的平均加樣迴收率為99.24%,RSD為1.65%(n=9),橙皮苷的平均加樣迴收率為99.39%,RSD為1.85%(n=9)。結論該方法具有良好的專屬性和重複性,加樣迴收率實驗符閤要求,能準確、穩定地對四味清口含片中桂皮醛和橙皮苷含量進行定量測定,可作為該製劑的質量控製方法。
목적：건립동시측정사미청구함편중계피철화등피감함량적방법。방법채용고효액상색보법( HPLC)：색보조건위Inertsil ODS_SP(4.6 mm×150 mm,5μm)색보주분리,검측파장위290 nm,류동상위을정-수진행제도세탈,류속위1.0 mL·min-1,주온위30℃,이론판수불저우3000。결과계피철진양량재0.025~0.500μg,등피감진양량재0.10~2.00μg범위내여봉면적적분치선성관계균량호；재정밀도실험、은정성실험、중복성실험중,계피철화등피감봉면적적상대표준편차(RSD)분별위1.16%화1.03%,1.27%화1.08%,1.23%화1.28%；계피철적평균가양회수솔위99.24%,RSD위1.65%(n=9),등피감적평균가양회수솔위99.39%,RSD위1.85%(n=9)。결론해방법구유량호적전속성화중복성,가양회수솔실험부합요구,능준학、은정지대사미청구함편중계피철화등피감함량진행정량측정,가작위해제제적질량공제방법。
Objective To establish a method for the determination of hesPeridin and cinnamaldehyde in siweiqing buccal tablets. Methods A high Performance liquid chromatograPhy ( HPLC) method was established. The chromatograPhic conditions were as follows: the chromatograPhic column Inertsil ODS_SP ( 4. 6 mmí150 mm, 5 μm ) with the mixture of acetonitrile and water as mobile Phase in gradient mode,the detection waVelength of 290 nm,the flow rate of 1. 0 mL·min-1 ,the column temPerature of 30℃,the theoretical Plate number no less than 3 000. Results The linear relationshiP between content and Peak area was obtained in the range of 0. 025-0. 500 μg for cinnamaldehyde and 0. 10-2. 00 μg for hesPeridin. RSD of the Peak area of cinnamaldehyde and hesPeridin for the Precision test,the stability test and the rePeatability test were 1. 16%and 1. 03%,1. 27%and 1. 08%,1. 23%and 1. 28%,resPectiVely. The aVerage recoVery of cinnamaldehyde was 99. 24%with RSD of 1. 65%(n=9). The aVerage recoVery of hesPeridin was 99. 39%with RSD of 1. 85%(n=9). Conclusion The method can be aPPlied to quantitatiVe assay of cinnamaldehyde and hesPeridin in siweiqing buccal tablets with good reProducibility and sPecificity. The recoVery result met the accePtance criteria. The method can effectiVely control the quality of siweiqing buccal tablets with good sPecificity,reProducibility and stability,and can be aPPlied to the quality control of siweiqing buccal tablets.
