关键词: 参麦地黄丸, 需氧菌总数, 不确定度

Abstract:

Objective： In order to reasonably characterize the measurement results， the influencing factors in the measurement process of total aerobic microbial count in shenmai dihuang pills were analyzed， and an evaluation method for the measurement uncertainty was established.Methods： The result of total aerobic microbial count in shenmai dihuang pills was determined according to the general rule of 1105 of the fourth part of Chinese Pharmacopoeia （2020 edition）.According to the mathematical model for calculating measured values， analyze the uncertainty components that affect the measured values， and calculate the test sample weight W， dilution volume V_F， sample volume V， colony number N， repeatability R， etc. based on the GUM method Class A assessment method. For the standard uncertainties of the five input quantities， the expanded uncertainty was calculated using a synthetic method.Results： The measurement value of total aerobic microbial count per g of shenmai dihuang pills was 785 cfu. The synthetic standard uncertainty was 19 cfu，while the standard uncertainty of the measurement value and repeatability measurement were 10 cfu and 16 cfu respectively. Then taking the inclusion factor k=2， while inclusion probability was about 95%， the expanded uncertainty was 38 cfu. So the detection result of the total aerobic microbial count per g of shenmai dihuang pills was （785±38） cfu.Conclusion： Measurement repeatability and colony count were the main sources of measurement uncertainty of total aerobic microbial count in shenmai dihuang pills. It is recommended to mix the sample well and ensure stable operation so that the colonies are clearly visible to obtain measurement values closer to the true value.

Key words: Shenmai dihuang pills； , Total aerobic microbial count； , Uncertainty