RESUMEN
【Objective】 To explore the optimal sampling scheme for functional indexes of blood components, so as to ensure the accuracy of sampling. 【Methods】 The operation characteristic curves of 5 sampling schemes as (4, 1), (6, 1), (8, 2), (10, 2) and (12, 3) were drawn based on the characteristic curve theory of sampling inspection, the discriminability of those 5 sampling schemes was compared, and the risk of misjudgment and omission of sampling schemes was analyzed. 【Results】 The discriminability of 5 sampling schemes from high to low were (10, 2), (6, 1), (12, 3), (8, 2) and (4, 1), ; the operation characteristic curves of scheme (10, 2) were in basic concordance with (6, 1), (12, 3) and (8, 2) as the percent defective was <0.25. The risk of misjudgment of the 5 sampling schemes was low, and the risk of omission was high in scheme (4, 1)(0.738, 3), and low in (10, 2) and (6, 1) (0.525 6 and 0.533 9, respectively). 【Conclusion】 On the premise of strictly controlling the process of blood collection and supply and ensuring the quality of blood preparations, the sampling scheme (4, 1) can effectively monitor the stability of the whole process. However, for blood preparations with high nonconforming rate, sampling scheme (6, 1) or (10, 2) was recommended as the sampling amount should be elevated appropriately.
RESUMEN
Objective:To provide specific suggestions for the reasonable application of various quality sampling inspection methods for Chinese herbal medicines in order to improve the scientificity of sampling inspection plan. Methods:The sampling inspection pro-gram and the overall quality of Chinese herbal medicines in Hubei province from 2014 to 2016 were reviewed and the existing problems were analyzed, finally, suggestions for improvement were proposed for the future work. Results and Conclusion:The current sampling inspection methods have made certain achievements;however, each method still needs optimization. It is suggested that the supervision sampling inspection be standardized to solidify the basis of sampling inspection, special sampling inspection be arranged periodically to target the complicated and recurring quality issues, and evaluation sampling inspection be strengthened for certain varieties to evaluate the overall quality status and discover the risk signals.