CN113188961A - Detection method for equivalent volume particle size distribution of medical compressed atomizer fog particles - Google Patents
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- 239000002245 particle Substances 0.000 title claims abstract description 81
- 238000001514 detection method Methods 0.000 title claims abstract description 9
- 230000006835 compression Effects 0.000 claims abstract description 18
- 238000007906 compression Methods 0.000 claims abstract description 18
- 238000012360 testing method Methods 0.000 claims abstract description 18
- 238000000034 method Methods 0.000 claims abstract description 10
- 238000001228 spectrum Methods 0.000 claims abstract description 10
- 238000003921 particle size analysis Methods 0.000 claims abstract description 6
- 238000005507 spraying Methods 0.000 claims abstract description 4
- 239000003595 mist Substances 0.000 claims description 9
- 238000005259 measurement Methods 0.000 claims description 7
- 230000035945 sensitivity Effects 0.000 claims description 7
- 239000003814 drug Substances 0.000 abstract description 16
- 230000000694 effects Effects 0.000 abstract description 7
- 239000007921 spray Substances 0.000 abstract description 5
- 238000004519 manufacturing process Methods 0.000 abstract description 4
- 238000011369 optimal treatment Methods 0.000 abstract description 2
- 210000002345 respiratory system Anatomy 0.000 description 6
- 238000000889 atomisation Methods 0.000 description 5
- 210000000621 bronchi Anatomy 0.000 description 4
- 239000007788 liquid Substances 0.000 description 4
- 210000004072 lung Anatomy 0.000 description 4
- 239000007789 gas Substances 0.000 description 3
- 238000011160 research Methods 0.000 description 3
- 201000010099 disease Diseases 0.000 description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 210000000214 mouth Anatomy 0.000 description 2
- 210000000056 organ Anatomy 0.000 description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 2
- 206010021143 Hypoxia Diseases 0.000 description 1
- 206010035664 Pneumonia Diseases 0.000 description 1
- 239000000443 aerosol Substances 0.000 description 1
- 238000003915 air pollution Methods 0.000 description 1
- 208000006673 asthma Diseases 0.000 description 1
- 230000008021 deposition Effects 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 238000002664 inhalation therapy Methods 0.000 description 1
- 208000030603 inherited susceptibility to asthma Diseases 0.000 description 1
- 208000030500 lower respiratory tract disease Diseases 0.000 description 1
- 239000011859 microparticle Substances 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 210000003456 pulmonary alveoli Anatomy 0.000 description 1
- 230000000241 respiratory effect Effects 0.000 description 1
- 208000023504 respiratory system disease Diseases 0.000 description 1
- 230000028327 secretion Effects 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 231100000331 toxic Toxicity 0.000 description 1
- 230000002588 toxic effect Effects 0.000 description 1
- 238000012795 verification Methods 0.000 description 1
- 230000009385 viral infection Effects 0.000 description 1
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N15/00—Investigating characteristics of particles; Investigating permeability, pore-volume or surface-area of porous materials
- G01N15/02—Investigating particle size or size distribution
- G01N15/0205—Investigating particle size or size distribution by optical means
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Abstract
The invention discloses a method for detecting equivalent volume particle size distribution of fog particles of a medical compression atomizer, which comprises the following steps: step S1), performing energy spectrum test after background test of the laser particle analyzer, aligning a nozzle to a test tube for spraying, and acquiring and storing data after a oscillogram is stable to obtain particle size analysis data; respectively calculate Er(V1)、Er(V2) And Er(V3) (ii) a By the formula
Calculating a relative error rate E of the measuring instrumentr(V); obtaining the real value interval [ V-E ] of the particle size distribution of the equivalent volume of the fog particlesr(V),V+Er(V)]. Compared with the prior art, the method for detecting the equivalent volume particle size distribution of the spray particles of the medical compressed atomizer has wide application range, can provide a metering detection method for production enterprises, standardizes the production of the spray particles, can ensure the accuracy and reliability of the medical compressed atomizer used in the market, and can ensure the use of the medical compressed atomizerThe patient can achieve the optimal treatment effect in dosage and frequency in a short time, the body and even life safety of the patient is ensured, and the side effect of the medicine on the body is reduced to the maximum extent.
Description
Technical Field
The invention relates to the field of medical equipment detection, in particular to a method for detecting equivalent volume particle size distribution of fog particles of a medical compression atomizer.
Background
With the development of industry, air pollution is severe, and the number of respiratory disease patients is greatly increased due to the sudden cold and warm climate during season change. At present, diseases such as bronchial asthma, respiratory virus infection, pneumonia and the like are in a high-incidence stage, and aerosol inhalation is one of the most effective methods for treating the diseases. Because the medicine directly enters the target organ of the respiratory tract and the lung by inhalation, the curative effect is faster and more effective than the oral medicine, and the dosage is only one tenth of the dosage of other administration modes at most, the toxic and side effect of the medicine is obviously reduced, especially for children. In inhalation therapy, the inhalation device plays a key role in how the drug is delivered to the respiratory tract and lungs of the patient.
The types of medical atomizers are three, and the main types are gas compression type air compression atomizers, ultrasonic atomizers and net atomizers. The atomizer of the ultrasonic atomizer has no selectivity to the atomized particles, so most of the generated medicine particles can only be deposited in the upper respiratory tract such as the oral cavity, the throat and the like, and the lower respiratory tract diseases can not be effectively treated due to the small deposition amount of the lung. Meanwhile, as the fog particles generated by the ultrasonic atomizer are large and the atomization is fast, the patient inhales excessive water vapor, the respiratory tract is humidified, the thick and dry secretion which partially blocks the bronchus in the respiratory tract originally expands after absorbing water, the respiratory tract resistance is increased, and the oxygen deficiency phenomenon can be generated. The mesh type atomizer extrudes a liquid medicine through holes of a nozzle type mesh type spray head by up-and-down vibration of a vibrator, sprays the liquid medicine by utilizing micro ultrasonic vibration and a mesh type spray head structure, and is convenient to carry and use at any time and any place.
Biomedical engineering research shows that the medicine with atomized particles of about 10 microns can only be deposited in oral cavity and throat parts, the medicine with the diameter of (3-6) microns can enter bronchus, and particles with the diameter of less than 2 microns can enter the finest bronchus and alveoli and be deposited in target organs. Most of the medical compressed atomized particles are about (1-5) mu m, so that the medicine can be fully deposited in the lung. Assessment of the therapeutic efficacy in addition to the diameter of the microparticles, another major factor is the amount of aerosolized drug per minute and the density or concentration of the mist. Medical clinical experiments show that the best atomization rate is (0.15-0.45) ml/min. The medical compression type atomization has large atomization amount which can reach more than 0.10ml/min and just can reach the best atomization effect.
The gas compression type air compression atomizer forms high-speed airflow by utilizing compressed air through a fine pipe orifice, the generated negative pressure drives the liquid medicine to be sprayed onto the obstruction together, and the liquid drops splash to the periphery under high-speed impact to be changed into mist-shaped particles to be sprayed out from the air outlet pipe. The gas compression type air compression atomizer is directly connected to the throat of a patient through a throat pipe, so that the medicine can directly reach the bronchus and alveolus of the patient.
According to the metering device related to the medical compressed atomizer, an inventor searches an IEC international electrotechnical commission international standard website, database articles such as a Hopkinson area, a Wanfang database, a Upu and the like, a China Standard service network, a national market supervision bureau website and various search websites for related information to obtain a standard that no medical compressed atomizer exists internationally, national standards and industrial standards for the medical compressed atomizer are not established at present at home, and related national standard documents refer to 'medical ultrasonic atomizer' (YY 0109-. But the detection method of the equivalent volume particle size distribution of the medical compressed atomizer fog particles is not mentioned.
Disclosure of Invention
Aiming at the problems in the prior art, the invention aims to provide a method for detecting the equivalent volume particle size distribution of the atomized particles of the medical compressed atomizer, and the method can be used for detecting the medical compressed atomizer and ensuring the accurate and reliable operation of the medical compressed atomizer.
The detection method for the equivalent volume particle size distribution of the atomized particles of the medical compression atomizer comprises the following steps:
step S1), opening a laser particle analyzer and detection software, and respectively checking whether a laser and a light path are normal;
step S2) carrying out energy spectrum test after the background test of the laser particle analyzer, displaying an energy spectrum test view, aiming a nozzle at a test tube for spraying, generating a waveform pattern on the energy spectrum test view, and acquiring and storing data after the waveform pattern is stable to obtain particle size analysis data;
step S3) according to the relative extended error rate U on the laser particle analyzer calibration certificate given by provincial institute of metrologyrel(Vs) Calculating relative error rate of laboratory instruments
Step S4) measuring the relative error rate E of the mist sprayed by the atomizing cup by using a laser particle size analyzer according to the formula (1) and measuring the particle size measurement result of the mistr(V2)；
Step S5) according to the formula
Calculating the particle size transparency relative error rate Er(V3)；
Step S6) calculating the relative error rate E of the measuring instrument according to the formula (2)r(V)；
Wherein, | ciI is the sensitivity coefficient, typically 1, k1、k2、k3Is a constant, usually 2 or 3, n is the number of measurements, ViFor the particle size measured the ith time with a laser particle sizer a single time,
measuring the average value of n-time particle sizes by using a laser particle size analyzer, wherein a is the maximum allowable error of volume calibration of the laser particle size analyzer;
step S7) obtaining a real value interval [ V-E ] of the particle size distribution of the equivalent volume of the fog particles according to the particle size analysis data obtained in the step S2) and the relative error rate obtained in the step S6)r(V),V+Er(V)]。
The research result of the invention can be applied to medical compression atomizers produced at home and abroad in the market, has wide application range and large amount, scientific research equipment also adopts novel instruments with high accuracy and reliability, and some instruments even have metering standards, not only can provide a metering detection method for manufacturing enterprises to standardize the production of the medical compression atomizers, but also can carry out metering detection on the medical compression atomizers in the market, ensure the accuracy and reliability of the medical compression atomizers in use, reduce medical disputes, provide legal guarantee for government supervision, more importantly, ensure that patients using the medical compression atomizers can achieve optimal treatment effect in dosage and frequency of medicine in a short time, ensure the body and even life safety of the patients, and reduce the side effect of the medicine on the body to the maximum extent. The metrological verification of the medical compression atomizer can save more unnecessary cost for hospitals and families, the life is only once, the inaccurate medical compression atomizer can cause harm to human bodies, some harm can not be reversed, sequela and even life can be threatened, and strong guarantee is provided for serving people with large quality, rebirth and promotion.
Detailed Description
The present invention is described in further detail below.
Step S1) according to the relative extended error rate U on the laser particle analyzer calibration certificate given by provincial institute of metrologyrel(Vs)＝2％，k12, sensitivity | ci1 is obtained
Step S2), opening a laser particle analyzer and detection software, and respectively checking whether a laser and a light path are normal;
step S3) carrying out energy spectrum test after the background test of the laser particle analyzer, displaying an energy spectrum test view, aiming a nozzle at a test tube for spraying, generating a waveform pattern on the energy spectrum test view, and acquiring and storing data after the waveform pattern is stable to obtain particle size analysis data;
step S4) the mist ejected from the atomizing cup was measured by the laser particle size analyzer in step S3, and weighed under the same conditionsRepeating the measurement 10 times, respectively measuring results of (%) 47.612, 47.671, 47.397, 47.368, 47.262, 47.496, 47.463, 47.441, 47.413 and 47.493, and measuring relative error rate E of the particle diameter of the mist sprayed from the atomizing cup by using a laser particle size analyzer according to formula (1)r(V2)＝0.117％；
Step S5) because a is 0.5%, k23 according to the formula
Calculating the particle size transparency relative error rate Er(V3)＝0.29％；
Calculating a relative error rate E of the measuring instrument according to equation (2)r(V)＝2.1％；
Wherein, | ciI is the sensitivity coefficient, typically 1, k1、k2、k3Is constant, k in this example1、k32, k23, n is the number of measurements, in this example n is 10, ViFor the particle size measured the ith time with a laser particle sizer a single time,
in order to measure the average value of 10-time particle sizes by using a laser particle analyzer, a is the maximum allowable error of volume calibration of the laser particle analyzer, and in the embodiment, a is 0.5%;
step S6) obtaining the real value interval [ V-E ] of the particle size distribution of the equivalent volume of the fog particles according to the relative error rate obtained in the step S1 and the particle size obtained in the step S4r(V),V+Er(V)]。
The above are merely examples of the present invention, and modifications, improvements and the like made by researchers within the technical scope of the present invention are included in the protection scope of the present invention.
Claims (5)
1. The detection method for the equivalent volume particle size distribution of the atomized particles of the medical compression atomizer is characterized by comprising the following steps of:
step S1), opening a laser particle analyzer and detection software, and respectively checking whether a laser and a light path are normal;
step S2) carrying out energy spectrum test after the background test of the laser particle analyzer, displaying an energy spectrum test view, aiming a nozzle at a test tube for spraying, generating a waveform pattern on the energy spectrum test view, and acquiring and storing data after the waveform pattern is stable to obtain particle size analysis data;
step S3) calculating the relative error rate E of the experimental instrumentr(V1)；
Step S4) calculating the relative error rate E of the particle size measurement resultsr(V2)；
Step S5) calculating a granularity transparency relative error rate Er(V3)；
Step S6) calculating the relative error rate Er(V)；
Step S7) obtaining a real value interval [ V-E ] of the particle size distribution of the equivalent volume of the fog particles according to the particle size analysis data obtained in the step S2 and the relative error rate obtained in the step S6)r(V),V+Er(V)]。
2. The method for detecting the equivalent volume and particle size distribution of the mist particles of the medical compressed atomizer according to claim 1, wherein step S3) is specifically as follows: relative extended error rate U on laser particle sizer calibration certificate given by provincial institute of metrologyrel(Vs) Computing
Wherein, | ciI is the sensitivity coefficient, typically 1, k1Is a constant, typically 2 or 3.
3. The method for detecting the particle size distribution of the medical compressed atomizer in the equivalent volume of the atomized particles as claimed in claim 1, wherein step S4) is specifically performed: measuring the particle size of the mist sprayed from the atomizing cup by a laser particle size analyzer according to the formula (1) to determine the relative error rate Er(V2)；
In the formula, Er(V2) Is the relative error rate of particle size measurements, where ciI is the sensitivity coefficient, usually 1, n is the number of measurements, ViFor the particle size measured the ith time with a laser particle sizer a single time,
the average value of n-order particle diameters is measured by a laser particle sizer.
4. The method for detecting the equivalent volume and particle size distribution of the mist particles of the medical compressed atomizer according to claim 1, wherein step S5) is specifically as follows: according to the formula
Calculating the particle size transparency relative error rate Er(V3) Wherein, | ciI is the sensitivity coefficient, typically 1, k2Is a constant, typically 2 or 3, and a is the maximum allowable error of the volume calibration of the laser particle size analyzer.
5. The method for detecting the particle size distribution of the mist equivalent volume of a compressed atomizer for medical use according to claim 1, wherein the relative error rate E of a measuring instrument is calculated according to the formula (2)r(V)；
In the formula, Er(V1) Relative error rate for laboratory instruments; er(V2) Relative error of particle size measurementA difference rate; er(V3) Particle size transparency relative error rate; l ciI is the sensitivity coefficient, typically 1, k1、k2、k3Is a constant, usually 2 or 3, k3Is a constant, typically 2 or 3.
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