中国兽药杂志
中國獸藥雜誌
중국수약잡지
CHINESE JOURNAL OF VETERINARY DRUG
2015年
2期
40-43
,共4页
于丽娜%徐嫄%韩宁宁%赵晖%郝利华
于麗娜%徐嫄%韓寧寧%趙暉%郝利華
우려나%서원%한저저%조휘%학리화
微生物检定法%硫酸卡那霉素注射液%效价%不确定度
微生物檢定法%硫痠卡那黴素註射液%效價%不確定度
미생물검정법%류산잡나매소주사액%효개%불학정도
microbiological method%kanamycin monosulfate for injection%biological value%uncertainty evaluation
为研究微生物检定法（管碟法）测定硫酸卡那霉素注射液生物效价试验中各因素对结果的影响，采用不确定度分析，将影响因素归纳为称量、稀释、加样、测定、平行试验，量化各不确定度分量，评估各因素的影响因子。结果表明，牛津杯加样体积对测定结果影响最大，提示试验中应尽可能精确控制加样体积。
為研究微生物檢定法（管碟法）測定硫痠卡那黴素註射液生物效價試驗中各因素對結果的影響，採用不確定度分析，將影響因素歸納為稱量、稀釋、加樣、測定、平行試驗，量化各不確定度分量，評估各因素的影響因子。結果錶明，牛津杯加樣體積對測定結果影響最大，提示試驗中應儘可能精確控製加樣體積。
위연구미생물검정법（관설법）측정류산잡나매소주사액생물효개시험중각인소대결과적영향，채용불학정도분석，장영향인소귀납위칭량、희석、가양、측정、평행시험，양화각불학정도분량，평고각인소적영향인자。결과표명，우진배가양체적대측정결과영향최대，제시시험중응진가능정학공제가양체적。
To evaluate the uncertainty of determination of kanamycin monosulfate for injection by the microbiological method in Chinese Veterinary Pharmacopoeia ( edition 2010 ) , a mathematied model was established to evaluate the factors affecting sample determination. Each component of uncertainty was calculated by analyzing the various variable parameters among the procedures. The combined uncertainty was finally obtained by synthesizing the uncertainties of various component variables. The volume of sample added into Oxford Cup effects result most. As a result, the added volume should be controlled accurately in the test.
