Chinese General Practice ›› 2024, Vol. 27 ›› Issue (06): 758-764.DOI: 10.12114/j.issn.1007-9572.2023.0233
• Original Research • Previous Articles
Received:
2023-03-13
Revised:
2023-07-04
Published:
2024-02-20
Online:
2023-11-21
Contact:
GAO Yi
通讯作者:
高怡
作者简介:
基金资助:
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URL: https://www.chinagp.net/EN/10.12114/j.issn.1007-9572.2023.0233
阻力档位 | 流量(L/s) | |||||||
---|---|---|---|---|---|---|---|---|
0.250 | 0.500 | 0.750 | 1.000 | 1.250 | 1.500 | 1.750 | 2.000 | |
R1 | ||||||||
标准流量/容积模拟器PIF(L/s) | 0.250 | 0.500 | 0.750 | 1.000 | 1.250 | 1.500 | 1.750 | 1.999 |
PF810 PIF(L/s) | 0.267 | 0.483 | 0.717 | 0.967 | 1.217 | 1.400 | 1.657 | 1.887 |
重复度(L/s) | 0 | 0 | 0 | 0 | 0 | 0 | 0.017 | 0.017 |
绝对误差(L/s) | 0.017 | -0.017 | -0.033 | -0.033 | -0.033 | -0.100 | -0.094 | -0.113 |
相对误差(%) | 6.667 | -3.333 | -4.444 | -3.333 | -2.667 | -6.667 | -5.355 | -5.638 |
线性度(%) | 0 | 2.326 | 0 | 0 | 4.762 | -0.378 | 1.007 | |
R2 | ||||||||
标准流量/容积模拟器PIF(L/s) | 0.250 | 0.500 | 0.750 | 1.000 | 1.250 | 1.500 | 1.746 | 1.954 |
PF810 PIF(L/s) | 0.250 | 0.483 | 0.717 | 0.957 | 1.200 | 1.450 | 1.617 | 1.833 |
重复度(L/s) | 0 | 0 | 0 | 0.017 | 0 | 0.017 | 0 | 0 |
绝对误差(L/s) | 0 | -0.017 | -0.033 | -0.043 | -0.050 | -0.050 | -0.129 | -0.120 |
相对误差(%) | 0 | -3.333 | -4.444 | -4.333 | -4.000 | -3.346 | -7.407 | -6.166 |
线性度(%) | 3.448 | 2.326 | 1.045 | 0.556 | 0.014 | 4.895 | -0.484 | |
R3 | ||||||||
标准流量/容积模拟器PIF(L/s) | 0.250 | 0.500 | 0.750 | 1.000 | 1.250 | 1.497 | 1.726 | 1.935 |
PF810 PIF(L/s) | 0.267 | 0.483 | 0.713 | 0.950 | 1.183 | 1.377 | 1.580 | 1.783 |
重复度(L/s) | 0 | 0 | 0.017 | 0 | 0 | 0 | 0.017 | 0 |
绝对误差(L/s) | 0.017 | -0.017 | -0.037 | -0.050 | -0.066 | -0.121 | -0.146 | -0.152 |
相对误差(%) | 6.667 | -3.333 | -4.889 | -5.000 | -5.303 | -8.051 | -8.438 | -7.848 |
线性度(%) | 0 | 2.804 | 1.404 | 1.375 | 3.942 | 1.586 | 0.351 | |
R4 | ||||||||
标准流量/容积模拟器PIF(L/s) | 0.250 | 0.500 | 0.750 | 1.000 | 1.249 | 1.488 | 1.697 | 1.909 |
PF810 PIF(L/s) | 0.250 | 0.480 | 0.717 | 0.950 | 1.153 | 1.367 | 1.550 | 1.767 |
重复度(L/s) | 0 | 0.017 | 0 | 0 | 0.017 | 0 | 0 | 0 |
绝对误差(L/s) | 0 | -0.020 | -0.033 | -0.050 | -0.096 | -0.121 | -0.147 | -0.142 |
相对误差(%) | 0 | -4.000 | -4.444 | -5.000 | -7.689 | -8.129 | -8.684 | -7.446 |
线性度(%) | 4.167 | 1.860 | 1.754 | 3.994 | 1.820 | 1.708 | -0.298 | |
R5 | ||||||||
标准流量/容积模拟器PIF(L/s) | 0.250 | 0.500 | 0.750 | 0.999 | 1.215 | 1.456 | 1.680 | 1.987 |
PF810 PIF(L/s) | 0.233 | 0.467 | 0.700 | 0.933 | 1.100 | 1.333 | 1.373 | 1.450 |
重复度(L/s) | 0 | 0 | 0 | 0 | 0 | 0.017 | 0.033 | 0 |
绝对误差(L/s) | -0.017 | -0.033 | -0.050 | -0.066 | -0.115 | -0.123 | -0.306 | -0.537 |
相对误差(%) | -6.667 | -6.667 | -6.692 | -6.573 | -9.480 | -8.450 | -18.235 | -27.040 |
线性度(%) | 3.571 | 2.410 | 1.657 | 4.503 | 0.590 | 13.340 | 15.940 |
Table 1 Quality control evaluation results of PF810 flow test for inhalation drug quantitative assessment instrument
阻力档位 | 流量(L/s) | |||||||
---|---|---|---|---|---|---|---|---|
0.250 | 0.500 | 0.750 | 1.000 | 1.250 | 1.500 | 1.750 | 2.000 | |
R1 | ||||||||
标准流量/容积模拟器PIF(L/s) | 0.250 | 0.500 | 0.750 | 1.000 | 1.250 | 1.500 | 1.750 | 1.999 |
PF810 PIF(L/s) | 0.267 | 0.483 | 0.717 | 0.967 | 1.217 | 1.400 | 1.657 | 1.887 |
重复度(L/s) | 0 | 0 | 0 | 0 | 0 | 0 | 0.017 | 0.017 |
绝对误差(L/s) | 0.017 | -0.017 | -0.033 | -0.033 | -0.033 | -0.100 | -0.094 | -0.113 |
相对误差(%) | 6.667 | -3.333 | -4.444 | -3.333 | -2.667 | -6.667 | -5.355 | -5.638 |
线性度(%) | 0 | 2.326 | 0 | 0 | 4.762 | -0.378 | 1.007 | |
R2 | ||||||||
标准流量/容积模拟器PIF(L/s) | 0.250 | 0.500 | 0.750 | 1.000 | 1.250 | 1.500 | 1.746 | 1.954 |
PF810 PIF(L/s) | 0.250 | 0.483 | 0.717 | 0.957 | 1.200 | 1.450 | 1.617 | 1.833 |
重复度(L/s) | 0 | 0 | 0 | 0.017 | 0 | 0.017 | 0 | 0 |
绝对误差(L/s) | 0 | -0.017 | -0.033 | -0.043 | -0.050 | -0.050 | -0.129 | -0.120 |
相对误差(%) | 0 | -3.333 | -4.444 | -4.333 | -4.000 | -3.346 | -7.407 | -6.166 |
线性度(%) | 3.448 | 2.326 | 1.045 | 0.556 | 0.014 | 4.895 | -0.484 | |
R3 | ||||||||
标准流量/容积模拟器PIF(L/s) | 0.250 | 0.500 | 0.750 | 1.000 | 1.250 | 1.497 | 1.726 | 1.935 |
PF810 PIF(L/s) | 0.267 | 0.483 | 0.713 | 0.950 | 1.183 | 1.377 | 1.580 | 1.783 |
重复度(L/s) | 0 | 0 | 0.017 | 0 | 0 | 0 | 0.017 | 0 |
绝对误差(L/s) | 0.017 | -0.017 | -0.037 | -0.050 | -0.066 | -0.121 | -0.146 | -0.152 |
相对误差(%) | 6.667 | -3.333 | -4.889 | -5.000 | -5.303 | -8.051 | -8.438 | -7.848 |
线性度(%) | 0 | 2.804 | 1.404 | 1.375 | 3.942 | 1.586 | 0.351 | |
R4 | ||||||||
标准流量/容积模拟器PIF(L/s) | 0.250 | 0.500 | 0.750 | 1.000 | 1.249 | 1.488 | 1.697 | 1.909 |
PF810 PIF(L/s) | 0.250 | 0.480 | 0.717 | 0.950 | 1.153 | 1.367 | 1.550 | 1.767 |
重复度(L/s) | 0 | 0.017 | 0 | 0 | 0.017 | 0 | 0 | 0 |
绝对误差(L/s) | 0 | -0.020 | -0.033 | -0.050 | -0.096 | -0.121 | -0.147 | -0.142 |
相对误差(%) | 0 | -4.000 | -4.444 | -5.000 | -7.689 | -8.129 | -8.684 | -7.446 |
线性度(%) | 4.167 | 1.860 | 1.754 | 3.994 | 1.820 | 1.708 | -0.298 | |
R5 | ||||||||
标准流量/容积模拟器PIF(L/s) | 0.250 | 0.500 | 0.750 | 0.999 | 1.215 | 1.456 | 1.680 | 1.987 |
PF810 PIF(L/s) | 0.233 | 0.467 | 0.700 | 0.933 | 1.100 | 1.333 | 1.373 | 1.450 |
重复度(L/s) | 0 | 0 | 0 | 0 | 0 | 0.017 | 0.033 | 0 |
绝对误差(L/s) | -0.017 | -0.033 | -0.050 | -0.066 | -0.115 | -0.123 | -0.306 | -0.537 |
相对误差(%) | -6.667 | -6.667 | -6.692 | -6.573 | -9.480 | -8.450 | -18.235 | -27.040 |
线性度(%) | 3.571 | 2.410 | 1.657 | 4.503 | 0.590 | 13.340 | 15.940 |
Figure 3 Blan-altman plot of the PF810 VI instrument for quantitative evaluation of inhaled medication and the standard value of the standard flow/volume simulator
流量 | R1 | R2 | R3 | R4 | R5 | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1.000 L | 2.000 L | 3.000 L | 4.000 L | 1.000 L | 2.000 L | 3.000 L | 4.000 L | 1.000 L | 2.000 L | 3.000 L | 4.000 L | 1.000 L | 2.000 L | 3.000 L | 4.000 L | 1.000 L | 2.000 L | 3.000 L | 4.000 L | |
0.500 L/s | ||||||||||||||||||||
均值VI(L) | 0.993 | 1.980 | 2.960 | 3.900 | 1.000 | 1.980 | 2.967 | 3.977 | 1.000 | 1.960 | 2.960 | 3.960 | 0.990 | 2.010 | 2.943 | 3.967 | 1.000 | 1.980 | 2.970 | 4.010 |
重复度(L/s) | 0.010 | 0 | 0 | 0 | 0 | 0 | 0.010 | 0.030 | 0 | 0 | 0 | 0.020 | 0 | 0 | 0.010 | 0.010 | 0 | 0 | 0 | 0 |
绝对误差(L/s) | -0.007 | -0.020 | -0.040 | -0.033 | 0 | -0.020 | -0.033 | -0.023 | 0 | -0.040 | -0.040 | -0.040 | -0.010 | 0.010 | -0.047 | -0.033 | 0 | -0.020 | -0.030 | 0.010 |
相对误差(%) | -0.667 | -1.000 | -1.333 | -0.847 | 0 | -1.000 | -1.111 | -0.583 | 0 | -2.000 | -1.333 | -1.000 | -1.000 | 0.500 | -1.572 | -0.833 | 0 | -1.000 | -1.000 | 0.250 |
线性度(%) | 0.889 | 0.800 | -0.192 | 1.333 | 0.533 | 0.286 | 2.667 | 0 | 0 | -1.333 | 2.284 | -0.391 | 1.333 | 0.400 | -1.143 | |||||
1.000 L/s | ||||||||||||||||||||
均值VI(L) | 1.000 | 1.983 | 2.950 | 3.960 | 1.000 | 1.980 | 2.943 | 3.950 | 1.000 | 1.990 | 2.960 | 3.970 | 1.010 | 2.010 | 2.990 | 4.010 | 1.000 | 1.980 | 2.960 | 3.960 |
重复度(L/s) | 0 | 0.010 | 0 | 0 | 0 | 0 | 0.010 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
绝对误差(L/s) | 0 | -0.017 | -0.043 | -0.040 | 0 | -0.020 | -0.047 | -0.048 | 0 | -0.010 | -0.040 | -0.030 | 0.010 | 0.010 | -0.010 | 0.010 | 0 | -0.020 | -0.040 | -0.040 |
相对误差(%) | 0 | -0.833 | -1.448 | -1.000 | 0 | -1.000 | -1.583 | -1.209 | 0 | -0.500 | -1.333 | -0.750 | 1.000 | 0.500 | -0.333 | 0.250 | 0 | -1.000 | -1.333 | -1.000 |
线性度(%) | 1.111 | 1.068 | -0.095 | 1.333 | 1.095 | -0.029 | 0.667 | 1.200 | -0.286 | 0 | 0.800 | -0.762 | 1.333 | 0.800 | 0 | |||||
1.500 L/s | ||||||||||||||||||||
均值VI(L) | 1.000 | 1.970 | 2.930 | 3.920 | 1.000 | 1.990 | 2.970 | 3.970 | 1.000 | 1.970 | 2.940 | 3.940 | 1.000 | 1.980 | 2.960 | 3.970 | 0.983 | 1.980 | 2.990 | 3.150 |
重复度(L/s) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.010 | 0 | 0 | 0 |
绝对误差(L/s) | 0 | -0.030 | -0.049 | -0.049 | 0 | -0.010 | -0.030 | -0.030 | 0 | -0.030 | -0.020 | -0.049 | 0 | -0.020 | -0.040 | -0.030 | -0.017 | -0.020 | -0.010 | -0.002 |
相对误差(%) | 0 | -1.500 | -1.656 | -1.243 | 0 | -0.500 | -1.000 | -0.750 | 0 | -1.500 | -0.676 | -1.237 | 0 | -1.000 | -1.333 | -0.750 | -1.667 | -1.000 | -0.333 | -0.047 |
线性度(%) | 2.000 | 0.777 | 0 | 0.667 | 0.800 | 0 | 2.000 | -0.403 | 0.844 | 1.333 | 0.800 | -0.286 | 0.222 | -0.400 | -0.249 |
Table 2 Quality control evaluation results of PF810 volume test for inhalation drug quantitative assessment instrument
流量 | R1 | R2 | R3 | R4 | R5 | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1.000 L | 2.000 L | 3.000 L | 4.000 L | 1.000 L | 2.000 L | 3.000 L | 4.000 L | 1.000 L | 2.000 L | 3.000 L | 4.000 L | 1.000 L | 2.000 L | 3.000 L | 4.000 L | 1.000 L | 2.000 L | 3.000 L | 4.000 L | |
0.500 L/s | ||||||||||||||||||||
均值VI(L) | 0.993 | 1.980 | 2.960 | 3.900 | 1.000 | 1.980 | 2.967 | 3.977 | 1.000 | 1.960 | 2.960 | 3.960 | 0.990 | 2.010 | 2.943 | 3.967 | 1.000 | 1.980 | 2.970 | 4.010 |
重复度(L/s) | 0.010 | 0 | 0 | 0 | 0 | 0 | 0.010 | 0.030 | 0 | 0 | 0 | 0.020 | 0 | 0 | 0.010 | 0.010 | 0 | 0 | 0 | 0 |
绝对误差(L/s) | -0.007 | -0.020 | -0.040 | -0.033 | 0 | -0.020 | -0.033 | -0.023 | 0 | -0.040 | -0.040 | -0.040 | -0.010 | 0.010 | -0.047 | -0.033 | 0 | -0.020 | -0.030 | 0.010 |
相对误差(%) | -0.667 | -1.000 | -1.333 | -0.847 | 0 | -1.000 | -1.111 | -0.583 | 0 | -2.000 | -1.333 | -1.000 | -1.000 | 0.500 | -1.572 | -0.833 | 0 | -1.000 | -1.000 | 0.250 |
线性度(%) | 0.889 | 0.800 | -0.192 | 1.333 | 0.533 | 0.286 | 2.667 | 0 | 0 | -1.333 | 2.284 | -0.391 | 1.333 | 0.400 | -1.143 | |||||
1.000 L/s | ||||||||||||||||||||
均值VI(L) | 1.000 | 1.983 | 2.950 | 3.960 | 1.000 | 1.980 | 2.943 | 3.950 | 1.000 | 1.990 | 2.960 | 3.970 | 1.010 | 2.010 | 2.990 | 4.010 | 1.000 | 1.980 | 2.960 | 3.960 |
重复度(L/s) | 0 | 0.010 | 0 | 0 | 0 | 0 | 0.010 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
绝对误差(L/s) | 0 | -0.017 | -0.043 | -0.040 | 0 | -0.020 | -0.047 | -0.048 | 0 | -0.010 | -0.040 | -0.030 | 0.010 | 0.010 | -0.010 | 0.010 | 0 | -0.020 | -0.040 | -0.040 |
相对误差(%) | 0 | -0.833 | -1.448 | -1.000 | 0 | -1.000 | -1.583 | -1.209 | 0 | -0.500 | -1.333 | -0.750 | 1.000 | 0.500 | -0.333 | 0.250 | 0 | -1.000 | -1.333 | -1.000 |
线性度(%) | 1.111 | 1.068 | -0.095 | 1.333 | 1.095 | -0.029 | 0.667 | 1.200 | -0.286 | 0 | 0.800 | -0.762 | 1.333 | 0.800 | 0 | |||||
1.500 L/s | ||||||||||||||||||||
均值VI(L) | 1.000 | 1.970 | 2.930 | 3.920 | 1.000 | 1.990 | 2.970 | 3.970 | 1.000 | 1.970 | 2.940 | 3.940 | 1.000 | 1.980 | 2.960 | 3.970 | 0.983 | 1.980 | 2.990 | 3.150 |
重复度(L/s) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.010 | 0 | 0 | 0 |
绝对误差(L/s) | 0 | -0.030 | -0.049 | -0.049 | 0 | -0.010 | -0.030 | -0.030 | 0 | -0.030 | -0.020 | -0.049 | 0 | -0.020 | -0.040 | -0.030 | -0.017 | -0.020 | -0.010 | -0.002 |
相对误差(%) | 0 | -1.500 | -1.656 | -1.243 | 0 | -0.500 | -1.000 | -0.750 | 0 | -1.500 | -0.676 | -1.237 | 0 | -1.000 | -1.333 | -0.750 | -1.667 | -1.000 | -0.333 | -0.047 |
线性度(%) | 2.000 | 0.777 | 0 | 0.667 | 0.800 | 0 | 2.000 | -0.403 | 0.844 | 1.333 | 0.800 | -0.286 | 0.222 | -0.400 | -0.249 |
PF810模拟阻力档位 | 阻抗值[kPa1/2·(L·min)-1] | 相对误差(%) |
---|---|---|
低阻力 | ||
R2 | 0.025 | -0.70 |
准纳器(Accuhaler®/Diskus®) | 0.025 | |
中阻力 | ||
R3 | 0.035 | -3.72 |
都保(Turbuhaler®) | 0.036 | |
高阻力 | ||
R5 | 0.043 | 1.94 |
吸乐(HandiHaler®) | 0.042 |
Table 3 Comparison of simulated resistance of PF810 and internal resistance of DPI inhaler for inhalation drug quantitative assessment instrument
PF810模拟阻力档位 | 阻抗值[kPa1/2·(L·min)-1] | 相对误差(%) |
---|---|---|
低阻力 | ||
R2 | 0.025 | -0.70 |
准纳器(Accuhaler®/Diskus®) | 0.025 | |
中阻力 | ||
R3 | 0.035 | -3.72 |
都保(Turbuhaler®) | 0.036 | |
高阻力 | ||
R5 | 0.043 | 1.94 |
吸乐(HandiHaler®) | 0.042 |
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