补肾壮骨配方颗粒的HPLC指纹图谱研究

目的：建立补肾壮骨配方颗粒的指纹图谱。方法：采用高效液相色谱（HPLC）法。色谱柱为InertsilC18（250mm×4．6mm.5μm），流动相为乙腈-水（梯度洗脱），流速为1ml／min，检测波长为285nm。采用直观分析和相似度软件评价10批补肾壮骨配方颗粒指纹图谱的相似度。结果：建立了补肾壮骨配方颗粒的指纹图谱，10批样品共标定了9个共有峰，各色谱峰分离度较好、相似度较高，符合中药色谱指纹图谱研究的技术要求。结论：该方法准确、可靠，建立的HPLC指纹图谱可为补肾壮骨配方颗粒的质量控制提供科学准确的依据。

Study on HPLC Fingerprints of Bushen Zhuanggu Formula Granules

OBJECTIVE： To establish HPLC fingerprint of Bushen zhuanggu formula granules. METHODS： HPLC method was adopted. The separation was performed on Inertsil C18（250 mm×4.6 mm, 5 μm） column with mobile phase consisted of acetoni- trile-water （gradient elution） at the flow rate of 1 ml/min. The detection wavelength was set at 285 nm. The fingerprint similarity of 10 batches of Bushen zhuanggu formula granules was evaluated by visual analysis and similarity sottware. RESULTS： Fingerprint spectnma of Bushen zhuanggu formula granules was established. 10 batches of samples were detected and 9 peaks in the chromato- gram were common. There was a high similarity and each chromatographic peak was obtained with good separation, which were in line with the technical requirements of fingerprint of TCM. CONCLUSIONS： This method is accurate and reliable, and HPLC fin- gerprint provides a scientific basis for the quality control of Bushen zhuanggu formula granules.