CN112957254A - Carbon dioxide indicator, applications and methods - Google Patents

Carbon dioxide indicator, applications and methods Download PDF

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Publication number
CN112957254A
CN112957254A CN202110157118.5A CN202110157118A CN112957254A CN 112957254 A CN112957254 A CN 112957254A CN 202110157118 A CN202110157118 A CN 202110157118A CN 112957254 A CN112957254 A CN 112957254A
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China
Prior art keywords
carbon dioxide
indicator
bag
dioxide indicator
agent
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Pending
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CN202110157118.5A
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Chinese (zh)
Inventor
应丹青
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Nanjing Tianhua Technology Development Co ltd
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Nanjing Tianhua Technology Development Co ltd
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Priority to CN202110157118.5A priority Critical patent/CN112957254A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/18Arrangements for indicating condition of container contents, e.g. sterile condition

Abstract

The invention discloses a carbon dioxide indicator, application and a method, and belongs to the technical field of detection reagents. The method comprises the following steps: acid-base regulator, color-changing agent, surfactant, mildew inhibitor, ultraviolet resisting agent and diluent. The carbon dioxide indicator prepared by the invention can sense the concentration of carbon dioxide, and changes color according to the concentration of the carbon dioxide so as to try out that the carbon dioxide in the container is not leaked and ensure that the sodium bicarbonate is not deteriorated, thereby improving the use safety.

Description

Carbon dioxide indicator, applications and methods
Technical Field
The invention belongs to the technical field of detection reagents, and particularly relates to a carbon dioxide indicator, and application and a method thereof.
Background
The existing pharmaceutical sodium bicarbonate solutions are widely used in many fields, such as antidotes, artificial kidney dialysis solutions, peritoneal dialysis solutions, infusion solutions, artificial cerebrospinal fluids, intraocular irrigation fluids, etc. In such an aqueous pharmaceutical solution, the sodium bicarbonate ions are in equilibrium and as the carbon dioxide gas escapes, the pH of the aqueous solution gradually rises.
This can greatly impair the value of the use of sodium bicarbonate solutions over time, since one of the main objectives in using such a pharmaceutical solution is to maintain or correct the acid-base equilibrium. And the concentration of sodium bicarbonate ions in the solution is generally controlled to avoid harm. In addition, to prevent aging, pharmaceutical sodium bicarbonate solutions are now commonly packed in gas-tight plastic containers for the purpose of preventing carbon dioxide gas from volatilizing, thereby maintaining the requisite balance of sodium bicarbonate ion concentration and solution PH.
However, the gas permeability of the pharmaceutical plastic container material itself is such that, after such container is filled with an aqueous solution containing bicarbonate ions, carbon dioxide gas will permeate through the plastic container into the atmosphere over time, thereby causing an increase in the pH of the solution. Loss of carbon dioxide gas and an increase in solution PH can cause solution quality problems.
In order to overcome the defect that the sodium bicarbonate solution plastic container can not block the loss of carbon dioxide, the sodium bicarbonate solution inner packaging bag is placed in a high-barrier packaging material, and carbon dioxide gas is filled into the space between the two bags for protection.
However, even this two-pack technique is not completely effective in eliminating the effects of pinholes in, for example, the outer high barrier bag and the resulting gradual loss of carbon dioxide gas as a result of extended shelf life, and aqueous solutions with rising pH over time should be discarded as soon as possible to avoid inadvertent patient hazards.
Disclosure of Invention
The invention aims to solve the technical problems in the background technology, and provides a liquid carbon dioxide indicator with uniform and stable color, which can perform sensitive, correct and effective color indication and can visually distinguish the colors from the senses.
The invention adopts the following technical scheme: the carbon dioxide indicator comprises the following components in percentage by mass:
0.1% -10% of an acid-base regulator;
1% -10% of a color-changing agent;
0.1% -5% of a surfactant;
0.1% -5% of a mildew inhibitor;
1% -5% of an anti-ultraviolet agent;
70% -80% of a diluent;
the indicator changes color when the concentration of carbon dioxide reaches or exceeds a predetermined concentration, 3% of the predetermined concentration.
The pH value of the reagent is adjusted by the pH adjusting agent, and the color-changing agent is a main component for color development and color change; the surfactant is used for promoting components to be uniformly dispersed, the mildew preventive is used for preventing microorganisms from breeding, the ultraviolet resistant agent is used for preventing the color change effect from being attenuated, and the diluent is used for enabling the solution to be uniformly dissolved.
In a further embodiment, the pH adjusting agent is at least one of sodium hydroxide, citric acid, sodium bicarbonate, or sodium carbonate.
In a further embodiment, the color-changing agent is at least one of thymolphthalein, bromocresol green, bromothymol blue, methyl orange, methyl yellow, or phenol red.
In a further embodiment, the surfactant is cetyl alcohol or sodium dodecylbenzenesulfonate.
In a further embodiment, the mold inhibitor is one of calcium propionate, sodium sorbate, or benzoic acid.
In further embodiments, the anti-uv agent is carbon black, a benzophenone-based or a benzotriazole-based compound.
In further embodiments, the diluent is at least one of ethanol or distilled water.
The sodium bicarbonate solution was tested using a carbon dioxide indicator as described above.
An application method of a carbon dioxide indicator specifically comprises the following steps:
step one, preparing a carbon dioxide indicator according to a proportion;
step two, heat-sealing and packaging the carbon dioxide indicator in a film by adopting a liquid packaging machine to form an indicator bag;
thirdly, attaching the indicator bag to the outer wall of the container filled with the sodium bicarbonate, and sealing the container and the indicator bag by using a packaging bag;
and step four, when the concentration of the carbon dioxide in the packaging bag is more than or equal to 3%, the carbon dioxide indicator is changed from green to yellow.
The carbon dioxide indicator comprises: acid-base regulator, color-changing agent, surfactant, mildew inhibitor, ultraviolet resisting agent and diluent.
In a further embodiment, the package is pressed from polypropylene and polypropylene/or polyethylene;
the wrapping bag is bilayer structure, the wrapping bag is visual material.
The invention has the beneficial effects that: the carbon dioxide indicator prepared by the invention can sense the concentration of carbon dioxide, and changes color according to the concentration of the carbon dioxide so as to try out whether the sodium bicarbonate in the container is deteriorated or not, thereby improving the use safety.
Drawings
Fig. 1 is a schematic view of the structure of an indicator pouch.
Each of the labels in fig. 1 is: carbon dioxide indicator 1, film 2.
Detailed Description
The invention is further described with reference to specific examples.
In the prior art, in order to overcome the problem that a plastic container of sodium bicarbonate solution cannot block the loss of carbon dioxide, an inner packaging bag of sodium bicarbonate solution is placed in a high-barrier packaging material, and carbon dioxide gas is filled into a space between the two bags for protection (for example, japanese patent laid-open nos. 49675/1993, 261141/1993 and 339512/1994).
However, even this two-pack technique is not completely effective in eliminating the effects of pinholes in, for example, the outer high barrier bag and the resulting gradual loss of carbon dioxide gas as a result of extended shelf life, and aqueous solutions with rising pH over time should be discarded as soon as possible to avoid inadvertent patient hazards.
Many studies have been made to detect changes in carbon dioxide concentration in the middle of such a double-bag packaging interlayer of a bicarbonate drug solution. There is also a need to produce a large array of indicators that indicate changes in carbon dioxide concentration, and the advent of such technology has been a continuing need in the industry.
Detection of CO in bicarbonate liquid in Japan2Whether the leakage occurs or not is indicated by a gas-permeable plastic box containing bicarbonate-containing liquid or by carbon dioxide indicator ink printed on the outer bag, but the indicator process is complicated and the phenomenon of uneven color also occurs, and the invention has been developed on the basis of the reasons.
Accordingly, it is an object of the present invention to provide a liquid, uniform and stable carbon dioxide indicator which provides sensitive, accurate and effective color indication and visual sensory discrimination.
The carbon dioxide indicator comprises the following components in percentage by mass:
0.1% -10% of an acid-base regulator;
1% -10% of a color-changing agent;
0.1% -5% of a surfactant;
0.1% -5% of a mildew inhibitor;
1% -5% of an anti-ultraviolet agent;
70% -80% of a diluent;
the pH value of the reagent is adjusted by the pH adjusting agent, and the color-changing agent is a main component for color development and color change; the surfactant is used for promoting components to be uniformly dispersed, the mildew preventive is used for preventing microorganisms from breeding, the ultraviolet resistant agent is used for preventing the color change effect from being attenuated, and the diluent is used for enabling the solution to be uniformly dissolved.
In a further embodiment, the pH adjusting agent is at least one of sodium hydroxide, citric acid, sodium bicarbonate, or sodium carbonate.
In a further embodiment, the color-changing agent is at least one of thymolphthalein, bromocresol green, bromothymol blue, methyl orange, methyl yellow, or phenol red.
In a further embodiment, the surfactant is cetyl alcohol or sodium dodecylbenzenesulfonate.
In a further embodiment, the mold inhibitor is one of calcium propionate, sodium sorbate, or benzoic acid.
In further embodiments, the anti-uv agent is carbon black, a benzophenone-based or a benzotriazole-based compound.
In further embodiments, the diluent is at least one of ethanol or distilled water.
The sodium bicarbonate solution was tested using a carbon dioxide indicator as described above.
An application method of a carbon dioxide indicator specifically comprises the following steps:
step one, preparing a carbon dioxide indicator according to a proportion;
step two, heat-sealing and packaging the carbon dioxide indicator in a film by adopting a liquid packaging machine to form an indicator bag;
thirdly, attaching the indicator bag to the outer wall of the container filled with the sodium bicarbonate, and sealing the container and the indicator bag by using a packaging bag; the packaging bag herein has high barrier properties, particularly, good carbon dioxide gas barrier properties.
And step four, when the concentration of the carbon dioxide in the packaging bag is more than or equal to 3%, the carbon dioxide indicator is changed from green to yellow.
The carbon dioxide indicator comprises: acid-base regulator, color-changing agent, surfactant, mildew inhibitor, ultraviolet resisting agent and diluent.
In a further embodiment, the package is pressed from polypropylene and polypropylene/or polyethylene; the wrapping bag is bilayer structure, the wrapping bag is visual material.
In this embodiment, the reason why the film is formed by pressing polypropylene and polypropylene/or polyethylene is that the film made of polypropylene and/or polyethylene has the characteristic of carbon dioxide permeability, so that the indicator liquid in the packaging film can detect carbon dioxide.
Example 1
Step one, preparing a carbon dioxide indicator: the following reagents are respectively selected according to the mass percentage: 8% of sodium hydroxide, 2% of bromocresol green and 2% of bromothymol blue, 4% of hexadecanol, 3% of calcium propionate, 4% of carbon black and 77% of ethanol.
Step two, preparing a film: the film is of a double-layer structure, the first layer is polypropylene, the second layer is also polypropylene, and the film is formed by pressing;
step three, heat-sealing and packaging the carbon dioxide indicator prepared in the step one in a film by adopting a liquid packaging machine to form an indicator bag; the packaged form of the indicator is a back seal;
and step four, attaching the indicator bag to the outer wall of the container filled with the sodium bicarbonate, and sealing the container and the indicator bag by using a packaging bag.
Example 2
Step one, preparing a carbon dioxide indicator: the following reagents are respectively selected according to the mass percentage: 5 percent of sodium bicarbonate and 4 percent of sodium carbonate, 1 percent of bromothymol blue, 5 percent of sodium dodecyl benzene sulfonate, 0.2 percent of sodium sorbate, 0.2 percent of benzoic acid, 5 percent of benzotriazole compounds and 79.6 percent of ethanol.
Step two, preparing a film: the film is of a double-layer structure, the first layer is polypropylene, the second layer is polyethylene, and the film is formed by pressing;
step three, heat-sealing and packaging the carbon dioxide indicator prepared in the step one in a film by adopting a liquid packaging machine to form an indicator bag; the packaged form of the indicator is a three-sided package;
and step four, attaching the indicator bag to the outer wall of the container filled with the sodium bicarbonate, and sealing the container and the indicator bag by using a packaging bag.
Example 3
Step one, preparing a carbon dioxide indicator: the following reagents are respectively selected according to the mass percentage: 10% of citric acid, 8% of methyl orange, 0.1% of sodium dodecyl benzene sulfonate, 5% of sodium sorbate, 1% of benzotriazole compound and 75.9% of ethanol.
Step two, preparing a film: the film is of a double-layer structure, the first layer is made of polyethylene, and the second layer is also made of polyethylene and is formed by pressing;
step three, heat-sealing and packaging the carbon dioxide indicator prepared in the step one in a film by adopting a liquid packaging machine to form an indicator bag; the packaged form of the indicator is a three-sided package;
and step four, attaching the indicator bag to the outer wall of the container filled with the sodium bicarbonate, and sealing the container and the indicator bag by using a packaging bag.
When the sodium bicarbonate decomposed out carbon dioxide and leaked out of the container, the carbon dioxide indicator changed from green to yellow when the concentration reached 3%.
Example 4
Step one, preparing a carbon dioxide indicator: the following reagents are respectively selected according to the mass percentage: 0.8 percent of citric acid, 7.6 percent of methyl orange, 4.2 percent of sodium dodecyl benzene sulfonate, 3.2 percent of sodium sorbate, 4.8 percent of benzotriazole compounds and 79.4 percent of ethanol are mixed to prepare the composition.
Step two, preparing a film: the film is of a double-layer structure, the first layer is polypropylene, the second layer is also polypropylene, and the film is formed by pressing;
step three, heat-sealing and packaging the carbon dioxide indicator prepared in the step one in a film by adopting a liquid packaging machine to form an indicator bag; the packaged form of the indicator is a three-sided package;
and step four, attaching the indicator bag to the outer wall of the container filled with the sodium bicarbonate, and sealing the container and the indicator bag by using a packaging bag.
When the sodium bicarbonate decomposed out carbon dioxide and leaked out of the container, the carbon dioxide indicator changed from green to yellow when the concentration reached 3%.
Example 5
Step one, preparing a carbon dioxide indicator: the following reagents are respectively selected according to the mass percentage: 10 percent of citric acid, 8 percent of methyl orange, 2.4 percent of sodium dodecyl benzene sulfonate, 3.4 percent of sodium sorbate, 5 percent of benzotriazole compound and 71.2 percent of ethanol.
Step two, preparing a film: the film is of a double-layer structure, the first layer is polypropylene, the second layer is also polypropylene, and the film is formed by pressing;
step three, heat-sealing and packaging the carbon dioxide indicator prepared in the step one in a film by adopting a liquid packaging machine to form an indicator bag; the packaged form of the indicator is a three-sided package;
and step four, attaching the indicator bag to the outer wall of the container filled with the sodium bicarbonate, and sealing the container and the indicator bag by using a packaging bag.
Example 6
Step one, preparing a carbon dioxide indicator: the following reagents are respectively selected according to the mass percentage: 10 percent of citric acid, 8 percent of methyl orange, 2.4 percent of sodium dodecyl benzene sulfonate, 3.4 percent of sodium sorbate, 5 percent of benzotriazole compound and 71.2 percent of ethanol.
Step two, preparing a film: the film is of a double-layer structure, the first layer is polypropylene, the second layer is also polypropylene, and the film is formed by pressing;
step three, heat-sealing and packaging the carbon dioxide indicator prepared in the step one in a film by adopting a liquid packaging machine to form an indicator bag; the packaged form of the indicator is a three-sided package;
and step four, attaching the indicator bag to the outer wall of the container filled with the sodium bicarbonate, and sealing the container and the indicator bag by using a packaging bag.
Detection example 1
Filling 10% CO into the interlayer between the inner packaging bag and the outer high barrier bag of the prepared sodium bicarbonate solution2The indicator can change from green to yellow when the mixed gas volume of air is 200ml, and the color change is visually checked when a pinhole (larger diameter about 500 μm) is punched in the outer high barrier bag. After several hours, the indicator turned from yellow to green and at this point the relative concentration of carbon dioxide gas in the interlayer of the inner and outer bags was 0.2%.
Detection example 2
Filling 30% CO into the interlayer between the inner packaging bag and the outer high barrier bag of the prepared sodium bicarbonate solution2The indicator can change from green to yellow when the mixed gas volume of air is 400ml, and the color change is visually checked when a pinhole (larger diameter about 500 μm) is punched in the outer high barrier bag. After several hours, the indicator turned from yellow to green and at this point the relative concentration of carbon dioxide gas in the interlayer of the inner and outer bags was 0.2%.
Detection example 3
Filling 90% CO into the interlayer between the inner packaging bag and the outer high barrier bag of the prepared sodium bicarbonate solution2The indicator can change from green to yellow when the mixed gas volume of air is 400ml, and the color change is visually checked when a pinhole (larger diameter about 500 μm) is punched in the outer high barrier bag. After several hours, the indicator turned from yellow to green and at this point inside the interlayer of the inner and outer bagsThe relative concentration of carbon dioxide gas was 0.2%.
The mechanism of occurrence of discoloration was analyzed as follows: the pH values of the indicators caused by different concentrations of carbon dioxide are different, and the carbon dioxide concentration is characterized by displaying different colors in different pH value ranges by using the color-changing agent.
The indicator is used for only carrying out sensory indication on whether a rated amount of carbon dioxide exists in the interlayer of the inner package and the outer package of the sodium bicarbonate solution, the indicator is green when being put into the packaging bag for use, the corresponding green color of the indicator changes into yellow when the carbon dioxide with a certain concentration in the interlayer is sensed, and the indicator changes from yellow to green if the carbon dioxide in the interlayer leaks.

Claims (10)

1. The carbon dioxide indicator is characterized by comprising the following components in percentage by mass:
0.1% -10% of an acid-base regulator;
1% -10% of a color-changing agent;
0.1% -5% of a surfactant;
0.1% -5% of a mildew inhibitor;
1% -5% of an anti-ultraviolet agent;
70% -80% of a diluent;
the indicator changes color when the concentration of carbon dioxide reaches or exceeds a predetermined concentration.
2. The carbon dioxide indicator of claim 1, wherein the pH adjusting agent is at least one of sodium hydroxide, citric acid, sodium bicarbonate, or sodium carbonate.
3. The carbon dioxide indicator of claim 1, wherein the color change agent is at least one of thymolphthalein, bromocresol green, bromothymol blue, methyl orange, methyl yellow, or phenol red.
4. The carbon dioxide indicator of claim 1, wherein the surfactant is cetyl alcohol or sodium dodecylbenzenesulfonate.
5. The carbon dioxide indicator of claim 1, wherein the mold inhibitor is one of calcium propionate, sodium sorbate, or benzoic acid.
6. The carbon dioxide indicator according to claim 1, wherein the ultraviolet light resistant agent is carbon black, a benzophenone compound or a benzotriazole compound.
7. The carbon dioxide indicator of claim 1, wherein the diluent is at least one of ethanol or distilled water.
8. Sodium bicarbonate solution to be tested using a carbon dioxide indicator according to any of claims 1 to 7.
9. An application method of a carbon dioxide indicator is characterized by comprising the following steps:
step one, preparing a carbon dioxide indicator according to a proportion;
step two, heat-sealing and packaging the carbon dioxide indicator in a film by adopting a liquid packaging machine to form an indicator bag;
thirdly, attaching the indicator bag to the outer wall of the container filled with the sodium bicarbonate, and sealing the container and the indicator bag by using a packaging bag;
step four, when the concentration of the carbon dioxide in the packaging bag is more than or equal to 3%, the carbon dioxide indicator is changed from green to yellow;
the carbon dioxide indicator comprises: acid-base regulator, color-changing agent, surfactant, mildew inhibitor, ultraviolet resisting agent and diluent.
10. The method for using a carbon dioxide indicator according to claim 9, wherein the packaging bag is formed by pressing polypropylene and polypropylene/or polyethylene;
the wrapping bag is bilayer structure, the wrapping bag is visual material.
CN202110157118.5A 2021-02-04 2021-02-04 Carbon dioxide indicator, applications and methods Pending CN112957254A (en)

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Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1222069A (en) * 1996-06-17 1999-07-07 株式会社大塚制药工场 Package for container of liquid medicine containing bicarbonate and pH indicator
JP2003093474A (en) * 2001-06-14 2003-04-02 Otsuka Pharmaceut Factory Inc Bicarbonate containing chemical solution housed in package arranged with carbon dioxide indicator
CN1411496A (en) * 1999-12-15 2003-04-16 凸板印刷株式会社 Ink composition for detecting carbon dioxide and carbon dioxide indicator using same, and package having carbon dioxide indicator therein
US20080075633A1 (en) * 2006-09-25 2008-03-27 Rafael Ostrowski Carbon dioxide detector having borosilicate substrate
WO2008039423A2 (en) * 2006-09-25 2008-04-03 Nellcor Puritan Bennett Llc Carbon dioxide detector having borosilicate substrate
CN105213187A (en) * 2014-07-03 2016-01-06 四川科伦药业股份有限公司 A kind of packaging of sodium bicarbonate injection
CN105267034A (en) * 2014-07-03 2016-01-27 四川科伦药业股份有限公司 Package of sodium bicarbonate injection
CN107436303A (en) * 2017-07-10 2017-12-05 深圳九星印刷包装集团有限公司 Time passage instruction device
CN206809496U (en) * 2016-11-16 2017-12-29 华仁药业股份有限公司 A kind of packaging system with barrier property
CN109715777A (en) * 2016-07-25 2019-05-03 金诺斯公司 Device and compositions related and method for surface cleaning
CN211894410U (en) * 2019-12-27 2020-11-10 中国大冢制药有限公司 Sodium bicarbonate injection plastic packaging system with leakage indicating function

Patent Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1222069A (en) * 1996-06-17 1999-07-07 株式会社大塚制药工场 Package for container of liquid medicine containing bicarbonate and pH indicator
CN1411496A (en) * 1999-12-15 2003-04-16 凸板印刷株式会社 Ink composition for detecting carbon dioxide and carbon dioxide indicator using same, and package having carbon dioxide indicator therein
JP2003093474A (en) * 2001-06-14 2003-04-02 Otsuka Pharmaceut Factory Inc Bicarbonate containing chemical solution housed in package arranged with carbon dioxide indicator
US20080075633A1 (en) * 2006-09-25 2008-03-27 Rafael Ostrowski Carbon dioxide detector having borosilicate substrate
WO2008039423A2 (en) * 2006-09-25 2008-04-03 Nellcor Puritan Bennett Llc Carbon dioxide detector having borosilicate substrate
CN105213187A (en) * 2014-07-03 2016-01-06 四川科伦药业股份有限公司 A kind of packaging of sodium bicarbonate injection
CN105267034A (en) * 2014-07-03 2016-01-27 四川科伦药业股份有限公司 Package of sodium bicarbonate injection
CN109715777A (en) * 2016-07-25 2019-05-03 金诺斯公司 Device and compositions related and method for surface cleaning
CN206809496U (en) * 2016-11-16 2017-12-29 华仁药业股份有限公司 A kind of packaging system with barrier property
CN107436303A (en) * 2017-07-10 2017-12-05 深圳九星印刷包装集团有限公司 Time passage instruction device
CN211894410U (en) * 2019-12-27 2020-11-10 中国大冢制药有限公司 Sodium bicarbonate injection plastic packaging system with leakage indicating function

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