ABSTRACT
Objective:To evaluate the ability of light dispersive colorimetry to detect hemoglobin (Hb) in lipid blood samples and its feasibility as an alternative to plasmapheresis commonly used in the laboratory.Methods:Routine blood samples of 276 inpatients in Fujian Provincial Hospital from July 2020 to July 2021 were collected. Routine blood samples of 276 inpatients were collected. There were 169 males and 107 females, aged from 16 to 97 years. 183 non-lipid blood samples and 93 lipid blood samples were collected.(1) One case each of low, medium and high Hb value in non-lipid blood and lipid blood samples were collected, and the precision and the linearity of light scattering method was detected.(2)Non-lipid blood samples divided into Hb low-value group, median-value group and high-value group, which were measured by light scattering method and colorimetric method to compare Hb values. (3)Non-lipid blood samples were divided into Hb low-value group, median-value group and high-value group. Plasma exchange was carried out with different concentrations of fat emulsion. The bias and linearity of Hbc2 and Hbc1, Hbo2 and Hbc1 were analyzed by MedCalc19.1 software. The Hbc2 and Hbc1 bias ( CV%) and Hbo2 and Hbc1 bias ( CV%) were calculated. T test was used to analyze the influence of different concentrations of triglyceride on Hb bias.(4)Blood samples were divided into Hb low-value group, median-group and high-value group. The Hb of light scattering method was compared with the colorimetric method after plasma exchange. Results:(1)The intrabatch precision of light scattering method for non-lipid blood and lipid blood specimens was within the allowable range ( CV<1.5%), and the good linearity ( R2=1.000).(2)The bias of Hb measured by light scattering method and colorimetric method in the three groups was below 3.5%(-0.58±2.34,0.16±1.52,1.15±1.56), within the allowable total error range. The two methods have the equivalence and good linear relationship ( r=0.999).(3)The concentrations of Hbo2 in the low (except 4.1 mmol/L), medium and high Hbo2 groups were equivalent to those in the non-lipid blood colorimetry (Hbc1), and the two methods were well correlated. The results of light scattering method have nothing to do with the concentration of lipid blood.(4)There was no significant difference of the Hb between the light scattering method and plasma exchange method in three groups ( P>0.05), Both of them have equivalence and good correlation ( R2=0.968,0.948,0.870). Conclusion:Light scattering method can effectively reduce the effect of lipid blood on hemoglobin determination, and can replace the traditional plasma exchange method, which has high clinical application value.
ABSTRACT
OBJECTIVE:To establish the method for the determination of particle size distribution of Budesonide nasal spray, and to analyze the consistency of particle size distribution of spray samples. METHODS:Water was used as dispersant for mixing and dispersing(1800 r/min). The particle sizes [d(0.1),d(0.5),d(0.9)] corresponded to accumulative particle size of 10%,50%and 90%were used as characteristic value. The distribution of granularity was determined by laser scattering method. The consisten-cy of particle size distribution of samples from 2 manufacturers (A,B) were analyzed among different batches or same batch of same manufacturer by SAS 9.3 statistical software. RESULTS:The mean values of d(0.1),d(0.5) and d(0.9) were 3.96 μm, 29.58 μm and 67.10 μm in manufacturer A. The mean values of d(0.1),d(0.5)and d(0.9)were 2.00 μm,7.53 μm and 28.51 μm in manufacturer B. By analysis,there was great difference in particle size of samples from 2 manufacturers. The particle size of the samples from manufacturer A were larger than that of manufacturer B. The consistency among different batches from manufacturer B was better,and the consistency among same batch were all good from 2 manufacturers. CONCLUSIONS:The established meth-od is suitable for particle size distribution of Budesonide nasal spray and the consistency analysis of particle size distribution.
ABSTRACT
Objective:To establish a laser light scattering method for the determination of the particle size distribution of clostridium butyricum enterococcus triple viable powder and compare the results of the sieving method.Methods:The conditions of laser scattering method were as follows:the vibration sampling rate of 80%,the dispersion pressure of 0.05 MPa,the background and sample scan time of 15 s,the shading of 0.5%-5%,the refractive index of the particles of 1.55,the particle absorption rate of 0.01,and the injection volume of 0.1-0.2 g.The eigenvalues of the particle size distribution were determined,which were the particle size cumulative distribution map of 10%,50% and 90% of the particle size value and the volume average particle diameter D.Results:The RSDs of d(0.1),d(0.5) and d(0.9) were less than 5% in the methodology study.The results of laser light scattering method showed that the particle size of 93.3% samples was below 250 μm,that of 64.2% samples was below 150 μm,that of 51.4% samples was below 125 μm,and that of 31.3% samples was below 90 μm.The results of sieving method showed that the particle size of 96.6% was below 250 μm,that of 46.4% samples was below 150 μm,that of 23.5% samples was below 125 μm,and that of 1.4% samples was below 90 μm.Conclusion:Sieving method and laser light scattering method both can characterize the particle size distribution of the sample.The laser light scattering method is simple,accurate and producible,which is suitable for the particle size control of clostridium butyricum enterococcus triple viable powder.