葛根素注射液上市后产品质量比较

目的：对国内4个厂家葛根素注射液的质量进行考察，为控制产品质量提供科学依据。方法：采用RP-HPLC法，紫外检测器(λ=250 nm)测定葛根素含量，色谱柱为Luna 5μm C18 150 mm×4.6 mm，流动相为甲醇-水(28：72)，葛根素在0.01～0.13 mg/ml内线形良好(γ=0.9992，n=6)，RSD为1.60％(n=6)。结果：4种产品在含量和色泽方面存在差异。结论：为保证葛根素注射液的质量和疗效，进一步提高产品质量并且规范质量标准势在必行。

COMPARATIVE STUDY ON QUALITY OF 4 PUERARIN INJECTION PRODUCTS OF DIFFERENT MANUFACTURER

OBJECTIVE: In order to provide data for quality control of puerarin injection products,4 samples of different manufacturer were analyzed. METHODS: The puerarin content of the products was determined by RP-HPLC in Luna C18 column(150 mm×4.6mm,5tm) using a mobile phase of MeOH:H2O= 28:72 and a UV detector of 250 nm.RESULTS: A standard curve was obtained with a liner range of 0.01～0.13 mg/ml(γ =0.999 2,n=6) and a RSD of 1.60%(n=6).The puerarin content and color of the 4 products are quite different.CONCLUSION:In order to guarantee the quality and safety of the products,it is necessary to unify the specification and to improve the manufacture process of puerarin injection products.