中药复方制剂补肾壮阳胶囊高效液相指纹图谱研究

目的：建立中药复方补肾壮阳胶囊（WSKY）的HPLC指纹图谱，对不同批次间制剂进行质量控制。方法：色谱柱：采用C₁₈色谱柱（4.6 mm×250 mm，5 μm），以乙腈-水（各含体积分数为0.1%的甲酸）为流动相进行梯度洗脱，流速为0.5 mL·min^-1，进样量10 μL，柱温30℃，检测波长270 nm；建立补肾壮阳胶囊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12批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：建立的补肾壮阳胶囊HPLC指纹图谱的专属性、精密度、重复性和稳定性均良好；12批制剂的指纹图谱与对照指纹图谱的相似度值在0.921~0.970之间；覆盖该复方13味组方中药的13个共有特征指纹峰得到明确的化学指认。结论：上述建立的主要特征峰化学成分明确的HPLC指纹图谱基本反映该中药复方制剂中各味组方中药，多成分的整体特征，可以用于市售前产品的质量评价，以上工作可为提高WSKY整体质量控制方法提供实验依据。

HPLC fingerprint of Warm Supplementing Kidney Yang (WSKY) capsules

OBJECTIVE To establish the HPLC fingerprint of Warm Supplementing Kidney Yang (WSKY) capsules in different batches with similarity assay for quality control.METHODS The separation was developed on a C₁₈ column(4.6 mm×250 mm, 5 μm), by gradient elution with acetonitrile-water (both containing 0.1% formic acid) as the mobile phase, flow rate at 0.5 mL·min^-1, detection wavelength at 270 nm and column temperature at 35℃. An HPLC fingerprint of WSKY was set up and the quality of 12 batches of WSKY was evaluated by similarity assay. Furthermore, the main characteristic peaks in HPLC fingerprint of WSKY were identified by comparing the retention times with those chemical reference substances and were assigned preliminarily to the individual herbs.RESULTS The established HPLC fingerprint of WSKY was specific, precise, reproducible and stable. The similarity of 12 batches of WSKY was about 0.921 to 0.970. Thirteen main characteristic peaks from thirteen herbs of WSKY were chemically identified.CONCLUSION The established HPLC fingerprint with chemically identified main characteristic peaks represents the profile of WSKY and can be used for quality evaluation. The above work can provide the experimental basis to improve overall quality control of WSKY.