摘要
目的本文建立了比浊法测定多西环素效价的方法,为比浊法的进一步应用提供了依据。方法以金黄色葡萄球菌为试验菌,采用比浊法测定多西环素的含量,并对微生物比浊法、管碟法测定多西环素制剂的结果进行比较。结果多西环素的线性范围为1.0~3.3u/ml(r=0.9979),片剂平均回收率为99.84%,方法重复性良好(RSD为0.42%)。同时,多西环素制剂的比浊法和管碟法测定结果无显著性差异,可信限率均小于5%。结论比浊法具有简便、精确、快捷的特点,可以应用于该产品的质量控制。
Objective To establish a method for determining the microbial assays of doxycycline by turbidimetric method in or- der to provide a basis for further development. Methods Staphylococcus aureus was chosen as the test organism that the microbiological assay of doxycycline was determined by turbidimetric method while a comparision of turbidimetric method and cyclinder-plate was carried out. Results The linearity range of doxycycline was 1.0 - 3.3 u/ml( r = 0. 997 9). The average recoveries of doxycycline was 99.84%. The method had a good reproducible( RSD:0.42% ). The microbiological assay of doxycycline pharmaceutical preparations were united which determined by turbidimetric method and cylinder-plate method. The confidence rates were also less than 5%. Conclusion The re- suits indicated that the turbidimetric method could be used as quality control because of its convenience,accuracy and quickness.
出处
《药学实践杂志》
CAS
2013年第5期368-370,共3页
Journal of Pharmaceutical Practice
关键词
多西环素
效价含量
比浊法
doxyeycline
microbiological assay
turbidimetric method