CN109974820A - Pen-type insulin syringe Dose accuracy detection device and method - Google Patents

Pen-type insulin syringe Dose accuracy detection device and method Download PDF

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Publication number
CN109974820A
CN109974820A CN201910191063.2A CN201910191063A CN109974820A CN 109974820 A CN109974820 A CN 109974820A CN 201910191063 A CN201910191063 A CN 201910191063A CN 109974820 A CN109974820 A CN 109974820A
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China
Prior art keywords
pen
type insulin
insulin syringe
accuracy
rotary shaft
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CN201910191063.2A
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CN109974820B (en
Inventor
饶兰
严鑫能
方旭超
张培茗
余勇
刘浩宇
王成
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Kailian Medical Technology (shanghai) Co Ltd
University of Shanghai for Science and Technology
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Kailian Medical Technology (shanghai) Co Ltd
University of Shanghai for Science and Technology
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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01FMEASURING VOLUME, VOLUME FLOW, MASS FLOW OR LIQUID LEVEL; METERING BY VOLUME
    • G01F25/00Testing or calibration of apparatus for measuring volume, volume flow or liquid level or for metering by volume

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  • Physics & Mathematics (AREA)
  • Fluid Mechanics (AREA)
  • General Physics & Mathematics (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

The invention discloses a kind of pen-type insulin syringe Dose accuracy detection device and methods, the branch of the present apparatus is set up in electronic balance top surface and is provided with elongated slot, measuring cup is set to the scale pan, rotary shaft is set to cradle top surface, the rotation of motor driven rotary shaft, grip block side connect rotary shaft and overturn in company with rotary shaft, and grip block opens up the through-hole of clamping pen-type insulin syringe between two parties, when grip block is overturn to horizontal position, pen-type insulin syringe syringe needle is located in measuring cup.This method drives pen-type insulin syringe syringe needle to be located in measuring cup by grip block, and setting detection dosage calculates accuracy limit value needed for determining and burst error;Electronic balance weighs the detection dose value of the insulin in injection rate cup and is compared with accuracy limit value and burst error, obtains Dose accuracy value.The present apparatus and method fill up the blank of pen-type insulin syringe Dose accuracy detection, ensure that the accuracy and safety of pen-type insulin syringe injection dosage.

Description

Pen-type insulin syringe Dose accuracy detection device and method
Technical field
The present invention relates to medical instrument detection technique field more particularly to a kind of pen-type insulin syringe Dose accuracies Detection device and method.
Background technique
Pen-type insulin syringe is a kind of needle-type injection medical instrument, and pen-type insulin syringe is main as shown in Figure 1: It is made of insulin dose adjusting key 11, pen-type insulin syringe core 12 and injection needle 13, by adjusting insulin agent Amount adjusting key 11 controls the dosage of insulin injection, from pen-type insulin syringe syringe needle 12 to human injection's insulin.
The examination criteria for not having pen-type insulin syringe injection dosage domestic at present, do not find yet correlation-detection system with The literature research of method, and the domestic test for pen-type insulin syringe is with reference to disposable insulin syringe standard YY/T 0197 is executed.But the standard comparing is simple, and the required precision of pen-type insulin syringe dosage, Bu Nengbao is not achieved Demonstrate,prove the accuracy and safety of pen-type insulin syringe.For pen-type insulin syringe, international standard ISO 11608-1 and It is the project that needle-type injection system (NIS) must satisfy that ISO 11608-4, which defines Dose accuracy, therefore for pen type pancreas islet The Dose accuracy detection of plain syringe is considerable.
Summary of the invention
Technical problem to be solved by the invention is to provide a kind of pen-type insulin syringe Dose accuracy detection devices And method, the present apparatus and method fill up the blank that pen-type insulin syringe Dose accuracy detects, reduce human factor and ring Influence of the border factor to testing result, improves detection working efficiency, ensure that the standard of pen-type insulin syringe injection dosage True property and safety.
In order to solve the above technical problems, pen-type insulin syringe Dose accuracy detection device of the present invention includes electronics day Flat, bracket, measuring cup, grip block, rotary shaft and motor, the branch is set up in the electronic balance top surface and cradle top surface is placed in the middle It is provided with elongated slot, the measuring cup is set to the scale pan of the electronic balance and is located in the bracket, and the rotary shaft passes through axle sleeve It is arranged vertically set on the cradle top surface and with the elongated slot, the motor is set to the cradle top surface and drives the rotation Shaft rotation, the grip block side connect the rotary shaft and overturn in company with the rotary shaft, and the grip block is opened between two parties If the through-hole of clamping pen-type insulin syringe, when the grip block is overturn to horizontal position, pen-type insulin syringe lower section It overturns through the elongated slot in the bracket and syringe needle is located in the measuring cup.
Further, the grip block side is climbed by ear is fixedly connected with the rotary shaft.
Further, the present apparatus further includes rubber ring, and the rubber ring is set to the through-hole wall that the grip block opens up between two parties.
Further, the present apparatus further includes host computer, the host computer and the electronic balance communication connection.
A kind of pen-type insulin syringe Dose accuracy detection method based on above-mentioned detection device includes the following steps:
Step 1: starting motor overturns grip block to upright position, pen-type insulin syringe insertion by rotary shaft In the through-hole of grip block, being again started up motor overturns grip block to horizontal position, and pen-type insulin syringe lower section is through elongated slot In overturning to bracket and syringe needle is located in measuring cup;
Step 2: adjusting the detection dosage of key assignments insulin by the dosage of pen-type insulin syringe, it is computed really Accuracy limit value needed for fixed and burst error;
Step 3: the insulin of setting is detected dosage injection rate cup, insulin detection agent in electronic balance scale taken amount cup Magnitude is simultaneously compared with accuracy limit value and burst error, obtains pen-type insulin syringe Dose accuracy value.
Further, the accuracy limit value calculation formula is as follows:
If Vset≤ TP, then:
U=Vset
L=Vset
If Vset> TP, then:
U=Vset+(β×Vset)/100
L=Vset-(β×Vset)/100
Wherein, U be the accuracy limit value upper limit, L be accuracy limit value lower limit, TP be transition point volume, TP=(100 × α)/ β, VsetDosage is detected for the insulin of setting, α is absolute error, and β is relative error.
Further, the burst error is calculated as follows:
A) for given test dose, the dosage average and standard deviation of test of many times are determined;
B) according to dosage average and standard deviation, determine that confidence level is 95% error coefficient;
C) mistake of two-sided statistical is calculated in the product of dosage average plus or minus standard deviation and error coefficient Poor section A:
Wherein:For dosage average, k is error coefficient, and s is standard error.
Further, insulin detection dose value is transmitted to host computer in the measuring cup that the electronic balance weighs, and host computer will The weight value weighed is converted to bulking value, and is compared with accuracy limit value and burst error, stores and exports pen type pancreas Island element syringe Dose accuracy value.
Since pen-type insulin syringe Dose accuracy detection device of the present invention and method use above-mentioned technical proposal, That is the branch of the present apparatus is set up in electronic balance top surface and is provided with elongated slot, and measuring cup is set to the scale pan of electronic balance, and rotary shaft is set to It cradle top surface and is arranged vertically with elongated slot, motor driven rotary shaft rotation, grip block side connects rotary shaft and in company with rotation Shaft overturning, grip block opens up the through-hole of clamping pen-type insulin syringe between two parties, when grip block is overturn to horizontal position, pen type Insulin syringe lower section is overturn through elongated slot in bracket and syringe needle is located in measuring cup.This method is by pen-type insulin syringe It is inserted into the through-hole of grip block and makes grip block overturning that pen-type insulin syringe syringe needle be driven to be located at amount by rotary shaft by motor In cup, setting detection dosage, and calculate and determine required accuracy limit value and burst error;Electronic balance weighs in injection rate cup Insulin detection dose value and be compared with accuracy limit value and burst error, obtain pen-type insulin syringe dosage Accuracy value.The present apparatus and method fill up pen-type insulin syringe Dose accuracy detection blank, reduce human factor and Influence of the environmental factor to testing result, improves detection working efficiency, ensure that pen-type insulin syringe injection dosage Accuracy and safety.
Detailed description of the invention
The present invention will be further described in detail below with reference to the accompanying drawings and embodiments:
Fig. 1 is pen-type insulin syringe structural schematic diagram;
Fig. 2 is pen-type insulin syringe Dose accuracy structure of the detecting device schematic diagram of the present invention;
Fig. 3 is bracket, rotary shaft and grip block connection schematic diagram in the present apparatus.
Specific embodiment
Embodiment is as shown in Figure 1, Figure 2 and Figure 3, and pen-type insulin syringe Dose accuracy detection device of the present invention includes Electronic balance 2, bracket 3, measuring cup 4, grip block 5, rotary shaft 6 and motor 7, the bracket 3 are set to 2 top surface of electronic balance simultaneously And 3 top surface of bracket is provided with elongated slot 31 between two parties, the measuring cup 1 is set to the scale pan of the electronic balance 2 and is located at the bracket 3 Interior, the rotary shaft 6 is set to 3 top surface of bracket by axle sleeve 61 and is arranged vertically with the elongated slot 31, and the motor 7 is set In 3 top surface of bracket and the rotary shaft 6 is driven to rotate, 5 side of grip block connects the rotary shaft 6 and companion The rotary shaft 6 is overturn, and the grip block 5 opens up the through-hole 51 of clamping pen-type insulin syringe 1, the grip block 5 between two parties When overturning to horizontal position, 1 lower section of pen-type insulin syringe is through in the elongated slot 31 overturning to the bracket 3 and syringe needle position In in the measuring cup 4.
Preferably, 5 side of grip block climbs 52 by ear and is fixedly connected with the rotary shaft 6.
Preferably, the present apparatus further includes rubber ring 8, and the rubber ring 8 is set to the through-hole 51 that the grip block 5 opens up between two parties Inner wall.Rubber ring is for improving and the frictional force of pen-type insulin syringe, it is ensured that pen-type insulin syringe is reliably located at folder It holds in the through-hole of plate, and facilitates the position for adjusting pen-type insulin syringe insertion grip block through-hole.
Preferably, the present apparatus further includes host computer 9, the host computer 9 and 2 communication connection of electronic balance.Host computer Integrated accuracy detection system, and electronic balance is connected by serial ports, each detection data of electronic balance can be generalized machine and adopt Collect and processing forms electrical form.
A kind of pen-type insulin syringe Dose accuracy detection method based on above-mentioned detection device includes the following steps:
Step 1: starting motor overturns grip block to upright position, pen-type insulin syringe insertion by rotary shaft In the through-hole of grip block, being again started up motor overturns grip block to horizontal position, and pen-type insulin syringe lower section is through elongated slot In overturning to bracket and syringe needle is located in measuring cup;
Step 2: adjusting the detection dosage of key assignments insulin by the dosage of pen-type insulin syringe, it is computed really Accuracy limit value needed for fixed and burst error;
Step 3: the insulin of setting is detected dosage injection rate cup, insulin detection agent in electronic balance scale taken amount cup Magnitude is simultaneously compared with accuracy limit value and burst error, obtains pen-type insulin syringe Dose accuracy value.
Preferably, the accuracy limit value calculation formula is as follows:
If Vset≤ TP, then:
U=Vset
L=Vset
If Vset> TP, then:
U=Vset+(β×Vset)/100
L=Vset-(β×Vset)/100
Wherein, U be the accuracy limit value upper limit, L be accuracy limit value lower limit, TP be transition point volume, TP=(100 × α)/ β, VsetDosage is detected for the insulin of setting, α is absolute error, and β is relative error.
Preferably, the burst error is calculated as follows:
A) for given test dose, the dosage average and standard deviation of test of many times are determined;
B) according to dosage average and standard deviation, determine that confidence level is 95% error coefficient;
C) mistake of two-sided statistical is calculated in the product of dosage average plus or minus standard deviation and error coefficient Poor section A:
Wherein:For dosage average, k is error coefficient, and s is standard error.
Preferably, insulin detection dose value is transmitted to host computer in the measuring cup that the electronic balance weighs, and host computer will The weight value weighed is converted to bulking value, and is compared with accuracy limit value and burst error, stores and exports pen type pancreas Island element syringe Dose accuracy value.
Due to parent drugs insulin preparation higher cost, this method is in practical application, can choose suitable reagent Carry out experiment test.Selection for reagent, concrete scheme can determine the physics of insulin agent by consulting pertinent literature Property and relevant testing conditions choose the liquid reagent for having similar physical property to original insulin agent, by selected liquid Check experiment is arranged in reagent and insulin agent, selects the test reagent that most suitable both errors are minimum and meet the requirements of the standard, To reduce testing cost.
The present apparatus and method breach the difficult point of the domestic test macro for not being exclusively used in pen-type insulin syringe at present, The influence of human factor and environmental factor to testing result is reduced, detection working efficiency is improved, ensure that pen-type insulin is infused The accuracy and safety of emitter injection dosage.

Claims (8)

1. a kind of pen-type insulin syringe Dose accuracy detection device, it is characterised in that: the present apparatus includes electronic balance, branch Frame, measuring cup, grip block, rotary shaft and motor, the branch is set up in the electronic balance top surface and cradle top surface is provided between two parties Elongated slot, the measuring cup are set to the scale pan of the electronic balance and are located in the bracket, and the rotary shaft is set to by axle sleeve It the cradle top surface and is arranged vertically with the elongated slot, the motor is set to the cradle top surface and drives the rotary shaft Rotation, the grip block side connect the rotary shaft and overturn in company with the rotary shaft, and the grip block opens up folder between two parties The through-hole of special pen-type insulin syringe, when the grip block is overturn to horizontal position, pen-type insulin syringe lower section is through institute Elongated slot is stated to overturn in the bracket and syringe needle is located in the measuring cup.
2. pen-type insulin syringe Dose accuracy detection device according to claim 1, it is characterised in that: the folder It holds plate side and is climbed by ear and be fixedly connected with the rotary shaft.
3. pen-type insulin syringe Dose accuracy detection device according to claim 1 or 2, it is characterised in that: this Device further includes rubber ring, and the rubber ring is set to the through-hole wall for pressing from both sides special plate and opening up between two parties.
4. pen-type insulin syringe Dose accuracy detection device according to claim 3, it is characterised in that: the present apparatus It further include host computer, the host computer and the electronic balance communication connection.
5. a kind of pen-type insulin syringe Dose accuracy detection based on any one of Claims 1-4 detection device Method, it is characterised in that this method includes the following steps:
Step 1: starting motor overturns grip block to upright position, pen-type insulin syringe insertion clamping by rotary shaft In the through-hole of plate, being again started up motor overturns grip block to horizontal position, and pen-type insulin syringe lower section is overturn through elongated slot In to bracket and syringe needle is located in measuring cup;
Step 2: adjusting the detection dosage of key assignments insulin by the dosage of pen-type insulin syringe, it is computed determining institute Need accuracy limit value and burst error;
Step 3: the insulin of setting is detected dosage injection rate cup, insulin detects dose value in electronic balance scale taken amount cup And be compared with accuracy limit value and burst error, obtain pen-type insulin syringe Dose accuracy value.
6. pen-type insulin syringe Dose accuracy detection method according to claim 5, it is characterised in that: the standard Exactness limit value calculation formula is as follows:
If Vset≤ TP, then:
U=Vset
L=Vset
If Vset> TP, then:
U=Vset+(β×Vset)/100
L=Vset-(β×Vset)/100
Wherein, U be the accuracy limit value upper limit, L be accuracy limit value lower limit, TP be transition point volume, TP=(100 × α)/β, Vset is the insulin detection dosage of setting, and α is absolute error, and β is relative error.
7. pen-type insulin syringe Dose accuracy detection method according to claim 5, it is characterised in that: the mistake Poor section is calculated as follows:
A) for given test dose, the dosage average and standard deviation of test of many times are determined;
B) according to dosage average and standard deviation, determine that confidence level is 95% error coefficient;
C) error region of two-sided statistical is calculated in the product of dosage average plus or minus standard deviation and error coefficient Between A:
Wherein:For dosage average, k is error coefficient, and s is standard error.
8. pen-type insulin syringe Dose accuracy detection method according to claim 5, it is characterised in that: the electricity Insulin detection dose value is transmitted to host computer in the measuring cup that sub- balance weighs, and the weight value weighed is converted to volume by host computer Value, and be compared with accuracy limit value and burst error, store and export pen-type insulin syringe Dose accuracy value.
CN201910191063.2A 2019-03-13 2019-03-13 Device and method for detecting dosage accuracy of pen type insulin syringe Active CN109974820B (en)

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Application Number Priority Date Filing Date Title
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Cited By (2)

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CN113588035A (en) * 2021-07-30 2021-11-02 山东省医疗器械和药品包装检验研究院 Dosage accuracy detection method for pen type insulin syringe
CN117109899A (en) * 2023-08-28 2023-11-24 巨翊科技(上海)有限公司 Measuring device and measuring method for motion parameters of push injection part of handle

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Publication number Priority date Publication date Assignee Title
CN113588035A (en) * 2021-07-30 2021-11-02 山东省医疗器械和药品包装检验研究院 Dosage accuracy detection method for pen type insulin syringe
CN113588035B (en) * 2021-07-30 2023-10-17 山东省医疗器械和药品包装检验研究院 Pen type insulin syringe dosage accuracy detection method
CN117109899A (en) * 2023-08-28 2023-11-24 巨翊科技(上海)有限公司 Measuring device and measuring method for motion parameters of push injection part of handle
CN117109899B (en) * 2023-08-28 2024-03-22 巨翊科技(上海)有限公司 Method for measuring motion parameters of push injection part of handle

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