注射用替考拉宁的组分分析

Component content analysis of teicoplanin for injection

目的采用高效液相色谱法测定4个厂家生产的注射用替考拉宁的组分含量,比较其异同;采用微生物检定法测定效价,初步探讨替考拉宁的组分与活性的关系。方法色谱柱为TSK-GEL ODS-100V（3）,4.6mm×150mm;流动相为磷酸盐缓冲液-乙腈,梯度洗脱;流速1.8mL/min;柱温40℃;检测波长254nm。培养基为抗生素检定用I号培养基,pH7.8~8.0;灭菌缓冲液为磷酸盐缓冲液,pH6.0;试验菌为枯草芽孢杆菌[CMCC（B）63501];高、低浓度分别为20U/mL和10U/mL。结果 4个厂家的产品的TA2-1和TA2-3的含量差异不大,但TA2-2、TA2-4和TA2-5的含量有较大差异;TA2-4和TA2-5的含量较高的产品的活性较高。结论替考拉宁的组分与活性的关系密切,研究者可据此对注射用替考拉宁进行有效的质量控制。

Objective To compare the component content of teicoplanin for injection provided by four manufactures and make preliminary study on the relationship between component content and potency,an HPLC method and microbiological assay were used.Methods A C18 column（TSK-GEL ODS-100V（3）,4.6mm×150mm） was used,and the mobile phase was phosphate buffer-acetonitrile with gradient elution.The flow rate was 1.8mL/min.The column temperature was kept at 40℃,and the detection wavelength was set at 254nm.For microbiological assay,medium No.I,pH7.8~8.0 and sterile phosphate buffer,pH6.0 were used.The test organism was Bacillus subtilis [CMCC（B）63501],and the high and low doses of teicoplanin were 20 and 10U/mL respectively.Results Among different products,no obvious difference was shown in contents of TA2-1 and TA2-3,but there were significant differences in contents of TA2-2,TA2-4 and TA2-5,and the products with higher contents of TA2-4 and TA2-5 shown higher potency.Conclusion The relationship between component content and potency of tecoplanin is closely,so that the quality of the products could be controlled effectively.