CAJ | 학술논문

[目的]建立参附滴丸、中间体浸膏中皂苷类成分的HPLC指纹图谱，为科学评价和有效控制参附滴丸的质量提供分析方法。[方法]采用Hypersil BDS C18柱（250 mm×4.6 mm，5μm）色谱柱，柱温25℃，流动相为乙睛、水，梯度洗脱，流速1.0mL·min-1，检测波长203nm，对参附滴丸、中间体浸膏中皂苷类成分分别进行指纹图谱测定，并比较分析两者之间的相似度及相关性。[结果]初步建立了10批参附滴丸和中间体浸膏中皂苷类成分的HPLC指纹图谱，其中滴丸确定了11个共有峰，而中间体浸膏则16个共有峰，中间体浸膏比滴丸多出5个共有峰，精密度和重复性实验中各共有峰相对保留时间和相对峰面积的RSD均小于3％，指纹图谱相似度均在0.9以上。[结论]所建立的HPLC指纹图谱方法具有较好的重复性，为参附滴丸的质量评价提供了有效的分析方法。
[목적]건립삼부적환、중간체침고중조감류성분적HPLC지문도보，위과학평개화유효공제삼부적환적질량제공분석방법。[방법]채용Hypersil BDS C18주（250 mm×4.6 mm，5μm）색보주，주온25℃，류동상위을정、수，제도세탈，류속1.0mL·min-1，검측파장203nm，대삼부적환、중간체침고중조감류성분분별진행지문도보측정，병비교분석량자지간적상사도급상관성。[결과]초보건립료10비삼부적환화중간체침고중조감류성분적HPLC지문도보，기중적환학정료11개공유봉，이중간체침고칙16개공유봉，중간체침고비적환다출5개공유봉，정밀도화중복성실험중각공유봉상대보류시간화상대봉면적적RSD균소우3％，지문도보상사도균재0.9이상。[결론]소건립적HPLC지문도보방법구유교호적중복성，위삼부적환적질량평개제공료유효적분석방법。
[Objective]The fingerprint chromatograms were established for quality evaluation of saponins in SHENFU Dropping Pil s and intermediate products by HPLC,thus to provide the analysis method for quality evaluation and quality control of the SHENFU Dropping Pil s.[Method]The analysis was performed on a Hypersil BDS C18 column(250mm ×4.6mm,5μm) at 25℃ with the mobile phase consisted of acetonitrile and water for gradient elution with the flow rate at 1.0mL·min-1. The detection of wavelength was at 203nm. Similarity and correlation of the fingerprints of the saponins in SHENFU Dropping Pil s and intermediate products were analyzed.[Result]Under the above chromatographic conditions, HPLC fingerprint of saponins in 10 batches SHENFU Dropping Pil s and 10 batch intermediate products was set up. 11 common peaks were found from SHENFU Dropping Pil s and 16 common peaks were found from intermediate products. Intermediate products had more 5 common peaks than SHENFU Dropping Pil s. The relative standard de-viations for relative retention time and relative peak areas were less than 3% in the precision and repeated test. Al of the similarity of samples was above 0.9.[Conclusion]The establishment of HPLC fingerprint had high repeatability. The method could be used for the quality evaluation of SHENFU Drop-ping Pil s.