摘要
目的:建立骨刺片制剂的指纹图谱测定方法和骨刺片指纹图谱的共有模式,比较、评价不同企业产品之间、相同企业不同批次产品之间的稳定性。方法:以乙腈-0.1%醋酸溶液为流动相,按照一定的梯度进行洗脱,柱温30℃,流速0.8 ml·min-1,检测波长283 nm,使用中药色谱指纹图谱相似度评价软件对结果进行评价。结果:本次抽检的6个厂家共100批骨刺片样品中只有一批样品的相似度<0.8,其余批次的产品制剂质量稳定,相似度>0.9。结论:HPLC指纹图谱技术快捷方便、稳定可靠,能有效的监测中药制剂的质量,值得在中药制剂质量控制方面推广应用。
OBJECTIVE To establish HPLC fingerprints of ingredients from Guci tablets,compare and evaluate homogeneity and stability of the products from different enterprises and different batches from same enterprises.METHODS Guci tablets were eluted at certain gradient on Inertsil ODS-SP C18（250 mm×4.6 mm,5μm）column with acetonitrile-0.1% acetic acid as the mobile phase,at a flow rate of 0.8 ml·min^-1 and column temperature of 30 ℃.Similarity of products were evaluated by using chromatographic fingerprint software.RESULTS Samples from100 batches of Guci tabletsI from6 enterprises were tested,only one batch with a similarity〈0.8,the rest have stable quality with a similarity〉0.9.CONCLUSION HPLC fingerprint technology is fast and convenient,stable and reliable,can be used to control quality of traditional Chinese medicines.This technology is worthy to be popularized in quality control of TCM products.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2015年第4期314-317,共4页
Chinese Journal of Hospital Pharmacy
关键词
骨刺片
指纹图谱
质量控制
Guci tablets
HPLC fingerprint
quality control
