肾宝片需氧菌总数测量不确定度评定

Evaluation of Uncertainty in the Count Test of Total Aerobic Bacteria in Shenbao Tablets

目的评定肾宝片需氧菌总数的测量不确定度。方法统计20份同一批号肾宝片的需氧菌总数,建立数学模型,分析测量不确定度的来源,并评定其的分量,采用合成的方法确定需氧菌总数测量的不确定度。结果肾宝片需氧菌总数的测量确定度来源主要有样品重复性检测、玻璃量器、加样体积、天平称量,其相对标准不确定度分别为0.0155,0.0046,0.0046,0.0082。结论样品重复性检测是影响肾宝片需氧菌总数测量不确定度评定的主要因素,需氧菌总数测量不确定度评定主要误差来源于微生物分布的不均匀性。

Objective To evaluate the uncertainty in the count test of the total number of aerobic bacteria in Shenbao Tablets.Methods The total number of aerobic bacteria in 20 samples of Shenbao Tablets with the same batch number was counted,the mathematical model was established to analyze the uncertainty sources and to evaluate the uncertainty components.The uncertainty of the count test of total aerobic bacteria was evaluated by the synthetic method.Results The main sources of the uncertainty of the count test of total aerobic bacteria in Shenbao Tablets were sample repeatability test,glass gauge,sample volume and weighing with balance.The relative standard uncertainties were 0.0155,0.0046,0.0046 and 0.0082,respectively.Conclusion The repeatability test of samples is the main factor affecting the uncertainty evaluation of the total number of aerobic bacteria in Shenbao Tablets.The main error of the evaluation of uncertainty in the count test of the total aerobic bacteria is due to the uneven distribution of microorganisms.