摘要
目的建立中药复方肠泰浸膏的HPLC指纹图谱,以对该制剂进行质量控制。方法采用C_(18)色谱柱(250 mm×4.6mm,5μm),以甲醇-水(含0.05%磷酸)为流动相进行梯度洗脱,紫外检测波长270 nm,流速1.0 mL·min^(-1),建立复方肠泰浸膏HPLC指纹图谱。运用"中药色谱指纹图谱相似度评价系统软件"对16批在研制剂进行相似度评价,通过比对化学分离对照品的保留时间,对主要特征峰进行明确化学指认并初步确定组方中药来源。结果建立的复方肠泰浸膏HPLC指纹图谱的专属性、精密度、重复性和稳定性均良好;16批制剂的指纹图谱与对照品图谱的相似度值为0.948~0.999;覆盖该复方四味组方中药的6个主要特征峰均得到明确的化学指认,指认峰面积约占总峰面积的70%。结论所建立的HPLC指纹图谱表达了上述中药复方制剂中多组分的整体特征,可以用于该复方肠泰浸膏的质量评价。
AIM To establish the HPLC fingerprint of Changtai extractum, a traditional Chinese medicine prescription, coupled with similarity assay for the quality control of its products. METHODS The separation was performed on a C18 column （250 mm × 4.6 mm, 5 μm） by gradient elution with methanol-water （ containing 0. 05% H3PO4） as the mobile phase with flow rate of 1.0 mL· min^-1 The UV detection was set at 270 nm. An HPLC fingerprint of Changtai extractum was set up and the quality of 16 batches of Changtai extractum was evalua- ted by similarity assay. Furthermore, the main characteristic peaks in HPLC fingerprint were identified by compa- ring the retention time with those of chemical reference substances and were assigned preliminarily to the individual herbs. RESULTS The established HPLC fingerprint was specific, precise, reproducible and stable. The similarity of 16 batches was between 0. 948 and 0. 999. Six main characteristic peaks from four herbs of Changtai extracturn were chemically identified, which occupied 70% peak area of all the main peaks. CONCLUSION The es- tablished HPLC fingerprint with chemically identified main characteristic peaks represents the profile of Changtai extractum and can he used for quality evaluation of its products. The above work can provide the experimental basis to improve overall quality control of Changtai extractum.
出处
《中国临床药学杂志》
CAS
2017年第3期185-189,共5页
Chinese Journal of Clinical Pharmacy
基金
国家自然科学基金(编号81274164
81473175)
