摘要
目的:比较用HPLC法和微生物法测定人血浆中头孢丙烯浓度的差异。方法:10名健康志愿者单剂量口服头孢丙烯片500 mg,分别用HPLC法和微生物法测定血浆中药物浓度。结果:HPLC法线性范围为0．143～14．300μg／mL,低、中、高浓度(0．357 5、1．430 0、7．150 0μg／mL)的回收率分别为(101．75±7．71)％、(96．89±2．55)％和(98．70±1．67)％(n= 6);3种浓度的日内、日间RSD分别为7．58％0、2．63％、1．69％和7．11％、3．77％、2．01％(n=6)。微生物法线性范围为0．25～3．00μg／mL,低、中、高浓度(0．50、1．75、3．00μg／mL)的回收率分别为(96．37±5．99)％、(108．26±8．39)％和(105．12±10．35)％(n=5);3种浓度的日内、日间RSD分别为9．84％、7．75％、6．22％和10．05％、8．31％、7．87％(n=5)。结论:两种方法回收率和精密度均符合要求,受试者各时间点平均血药浓度测定值无显著性差异。
Objective： To compare HPLC method and microbiological assay for determination of the contents of cefprozil in human plasma. Methods： Ten healthy volunteers were given a single oral dose of cefprozil 500 mg. The HPLC method and microbiological assay were used to determine the cefprozil plasma concentrations, respectively. Results： The calibration curve of HPLC method was linear within the range of 0. 143-14. 300 μg/mL. The recovery rates of HPLC method for 3 concentrations （0. 357 5,1. 430 0,7. 150 0 μg/mL） were （101.75±7.71）%, （96.89±2.55）% and （98.79±1.67）%, respectively （n=6）. Intra-day RSD were 7.58%, 2.63% and 1.69%, respectively and inter-day RSD were 7.11%, 3.77% and 2.01%, respectively （n=6）. The calibration curve of microbiological assay was linear in the range of 0.25-3.00 μg/mL. The recovery rates of microbiological assay for 3 concentrations （0.50, 1.75, 3.00 μg/mL） were （96.37 ± 5.99） %, （ 108.26 ± 8.39）% and （105.12±10.35）%, respectively （n=5）. Intra-day RSD were 9.84%, 7.75% and 6.22%, respectively and inter-day RSD were 10. 05 %, 8.31% and 7.87 %, respectively （n = 5 ）. Conclusion ： The recovery rate and the precision of the two methods are found to be similar. There is no significant difference in cefprozil plasma concentrations measured by HPLC method and microbiological assay.
出处
《药学服务与研究》
CAS
CSCD
2006年第5期348-350,共3页
Pharmaceutical Care and Research
关键词
头孢丙烯
色谱法
高压液相
微生物法
血药浓度
cefprozil
chromatography, high pressure liquid
microbiological assay
plasma concentration
