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以短小芽孢杆菌为检定菌，比较了培养基原料对抑菌圈的影响，进行了检定菌的分离和敏感活性测定，标准曲线的可倍限率检测；一剂量和二剂量法的可靠性试验；样品效价测定和统计分析，确认我们建立的硫酸西梭霉素的生测方法是准确、可行的。＊ｐ＜０．００１），试品间和偏离平行不显著（＊ｐ＞０．０５），可倍限率小于５％，本实验成立。按ｎ次实验结果合并计算，处理２＃、３＃两批样品的实验结果，见表４。经统计分析，２＃样品标定效价为６２９ｕｇ／ｍｇ，可倍限率４．１９％。３＃样品标定效价５７９ｕｇ／ｍｇ，可倍限率３．７１％。３结论３．１硫酸西梭霉素生物效价测定，美国药典［１］以表皮葡萄球菌作检定菌。我们用短小芽孢杆菌作检定菌，抑菌圈清晰，菌液易于保藏，测定结果准确，复现性强。因此，短小芽孢杆菌可作为硫酸西梭霉素的检定菌，培养时间１４～１６小时，培养温度３５～３７℃。３．２采用标准曲线法和二剂量法进行生物效价测定。前者标准品溶液校正点为５ｕｇ／ｍｌ，后者标准品溶液浓度分别为１０ｕｇ／ｍｌ，５ｕｇ／ｍｌ，剂距比２：１。３．３试验结果表明，培养基的原料直接影响检定菌的生长和样品扩散，从而影响抑菌圈的大小和清晰程度。蛋白陈和琼脂的质量尤为重量。?
Bacillus pumilus was used as the test strain to compare the effect of the medium on the bacteriostasis inhibition zone. The separation of the test bacteria and the determination of the sensitivity activity were carried out, and the limit test of the standard curve was carried out. The reliability test of one dose and two doses The sample titer and statistical analysis confirmed that the bioassay method of sisamycin sulfate we established was accurate and feasible. * P <0.001). There was no significant difference between the samples and the parallel deviation (* p> 0.05), and the limit of multiple was less than 5%. The experiment was established. Press n times the experimental results were combined to calculate the experimental results of 2 #, 3 # two batches of samples, shown in Table 4. According to the statistical analysis, the titer of 2 # sample was 629ug / mg, the limit of 4.19%. The titer of 3 # sample was 579ug / mg, which was 3.71% of the limit. 3 Conclusion 3.1 sisamycin biological potency determination, the United States Pharmacopoeia [1] Staphylococcus epidermidis for the test bacteria. We use Bacillus pumilus as test bacteria, bacteriostasis clear, easy to store bacteria, the determination of accurate results, reproducibility and strong. Therefore, Bacillus pumilus can be used as a test of fosfomycin sulfate, culture time 14 to 16 hours, culture temperature 35 ~ 37 ℃. 3.2 using standard curve method and two dosimetry biological potency determination. The former standard solution of the calibration point of 5ug / ml, the latter standard solution concentrations were 10ug / ml, 5ug / ml, the distance ratio of 2: 1.3.3 The test results show that the media directly affect the test material Growth and sample diffusion, which affects the size and clarity of inhibition zone. The quality of protein Chen and agar is particularly heavy. ?