摘要
目的:建立天舒胶囊指纹图谱的高效液相色谱分析方法,并对35批天舒胶囊进行相似度评价。方法:采用Phenomenex Luna C18(250 mm×4.6 mm,5μm)为色谱柱,流动相为甲醇-0.1%磷酸溶液,流速为1.0 mL/min,检测波长为276 nm,柱温为30℃和梯度洗脱的方法进行色谱分离。结果:所得天舒胶囊及其对照品的指纹图谱,采用国家药典委员会"中药指纹图谱相似度评价系统(2004 B版)"进行相似性评价,其35批样品的相似度均大于0.85。结论:建立的天舒胶囊HPLC指纹图谱检测方法简便、重复性好,可用于天舒胶囊的质量控制及其安全性评价。
Objective： To establish the fingerprint of Eanshu capsule by high performance liquid chromatography （HPLC） and to evaluate the similarity of 35 batches of Tianshu capsule. Methods： Phenomenex Luna C18 column （250 mm × 4.6 mm, 5 μm） was used for separation. The mobile phase consisted of methanol and 0.1% phosphoric acid solution. The flow rate was 1.0 mL/min using a gradient elution mode. The UV detection wavelength was set at 276 nm and the column temperature was kept at 30℃. Results： Fingerprints of Tianshu capsule and of reference standards were established. The similarity was evaluated by ＂Traditional Chinese Medicine Fingerprint Similarity Evaluation System （2004 B Edition）＂ of National Pharmacopoeia Committee. The similarity factor for 35 batches of samples was over 0.85. Conclusion： The product quality of 35 batches in this study was stable. The fingerprint detection method is easy to use and reliable, and therefore it can be used for quality control of Tianshu capsule or in further studies of safety profiles.
出处
《抗感染药学》
2013年第2期115-118,共4页
Anti-infection Pharmacy
