CN115637075A - Formula and preparation method of pressure steam sterilization indicating ink - Google Patents
Formula and preparation method of pressure steam sterilization indicating ink Download PDFInfo
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- CN115637075A CN115637075A CN202211065896.2A CN202211065896A CN115637075A CN 115637075 A CN115637075 A CN 115637075A CN 202211065896 A CN202211065896 A CN 202211065896A CN 115637075 A CN115637075 A CN 115637075A
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Abstract
The invention provides an indicating ink for pressure steam sterilization, and relates to the technical field of pressure steam sterilization. The sterilization indicating ink formula comprises the following materials in parts by weight: 5-20% of connecting material, 10-40% of reaction factor bismuth compound, 10-30% of resistance regulating factor of sulfur compound, 5-10% of resistance regulating factor and 40-60% of diluent. The preparation method of the pressure steam sterilization indicating ink comprises the following steps: adding the diluent into an ink barrel, adding the binder, the color-developing factor and the resistance-adjusting factor, uniformly stirring, grinding for 4-5h by a machine to obtain ink, printing, polishing oil and drying. The invention is suitable for monitoring the pressure steam sterilization effect of hospitals and epidemic prevention departments. The invention relates to a special chemical indicator card for pressure steam sterilization, which indicates whether a sterilization effect is achieved or not by changing the original color of an indicator into black after a period of time under the condition of certain pressure steam.
Description
Technical Field
The invention relates to the technical field of steam sterilization, in particular to a formula of indicating ink for pressure steam sterilization and a preparation method thereof.
Background
The information in this background section is only for enhancement of understanding of the general background of the invention and is not necessarily to be construed as an admission or any form of suggestion that this information forms the prior art that is already known to a person of ordinary skill in the art.
Various products and articles including medical instruments, implements and instruments require sterilization and disinfection prior to use to prevent biological contamination of wound sites, samples, organs, etc. Many sterilization processes are used, including contacting the product or item with a sterilizing agent. Examples of such disinfectants include steam, ethylene oxide, hydrogen peroxide, and the like. Steam sterilization is widely used because steam sterilizers can be used to subject batches of articles to sterilization conditions for up to 24 hours or more. In hospital medical treatment, various therapeutic medical devices are used, and these products require a strict sterilization treatment before use. The unqualified sterilization can cause the occurrence of hospital infection, and serious patients cause medical disputes. The method can judge whether the sterilization of the apparatus is qualified or not, and can trace back the apparatus at any time, and the apparatus can be stored for a long time as a proof that the sterilization of medical apparatuses in hospitals is qualified. Therefore, higher demands are made on routine examination and rapid identification of the sterilization effect.
Adequate sterilization conditions are typically monitored by placing an appropriate sterilization indicator in the sterilization chamber along with the product and/or item to be sterilized. Various sterilization indicators, including chemical indicators and biological indicators, are known and used for this purpose. The advantage of a chemical indicator is that it can be read immediately after the sterilization process is complete. The steam sterilization indicator composition used includes a polyvalent metal compound such as lead carbonate and sulfur. When the color of the indicator is fully developed under steam sterilization conditions, the indicator becomes brown or black.
Due to environmental problems, lead compounds have been replaced by other polyvalent metal compounds. As described in U.S. patent No.6,200,000, it has been proposed to replace lead in a given steam sterilization indicator composition with bismuth. U.S. Pat. No. 5,916,816 (Read), which includes, for example: bismuth carbonate was used. Thus, there is a continuing need for lead-free chemical indicators that are capable of indicating that the conditions of a steam sterilization process have been met. The invention relates to a chemical indicator composition, a chemical indicator comprising the composition, use of the indicator to determine the effectiveness of a sterilization process, a bismuth (III) compound selected from at least one organic group.
The patent CN 106634173A discloses a non-fading pressure steam sterilization chemical indication ink, a preparation method thereof and application thereof, wherein the ink is prepared from the following raw materials in percentage by weight: 15-30% of a connecting material; 20-30% of copper-containing compound; 5-10% of a sulfur-containing compound; 1-5% of a catalyst; 40-50% of a solvent; the preparation method comprises the following steps: firstly, dissolving a connecting material in a solvent, then sequentially adding a copper-containing compound, a sulfur-containing compound and a catalyst, stirring, and grinding to obtain a product; when in use, the product is used for gravure, flexible plate or silk screen plate, and is made into pressure steam sterilization chemical monitoring products in the form of indicating cards, indicating labels or indicating adhesive tapes, and can also be made into packaging materials. The invention can avoid the problem that the conventional bismuth salt chemical indicating ink or lead salt chemical indicating ink fades in the process of storing in a sterile room after changing color; the preparation method and the application are simple and feasible.
The ink has the problems that according to the national standard inspection requirements: and the qualified program is 134, 4min qualified black and 132, 3min qualified black, although the catalyst is present, no resistance regulating factor is added, so that the black gradient is not distinguished obviously, and false negative appears in the detection process of the instrument.
The patent CN 110128882A discloses steam sterilization chemical indicating ink rich in iron ions, a preparation method and application thereof, belongs to the field of chemical ink, and particularly relates to steam sterilization chemical indicating ink rich in iron ions, a preparation method and application thereof, which can avoid the harm of heavy metals; the preparation method and the application are simple and easy to implement.
The ink has the problems that the inspection requirements are met according to the general rule 1 of the sterilization chemical indicator of the medical health care products in the national standard GB 18282.1-2015: and the qualified program is 134, 4min qualified black and 132, 3min unqualified black, although the catalyst is added, the sensitivity is not enough, the color is developed into gray, the gradient distinction between the gray and the black is not obvious, and a false negative result appears in the detection process of a resistance instrument.
At present, common chemical indicating ink contains heavy metals such as lead ions, manganese ions or copper ions, and heavy metal poisoning of human bodies can be caused by excessive intake of the heavy metals. CN201611181226.1 adopts copper-containing compound to prepare chemical indicating ink, which avoids the harm of lead, but copper is heavy metal, and still has harm after directly contacting with human body in large quantity.
The patent US2014/0370604A1 adopts an organic bismuth compound, carbonate, a sulfur source, water and the like to prepare the aqueous pressure steam sterilization chemical indicator composition, and is more environment-friendly compared with solvent-based components. Most of the commercially available chemical indicators to date adopt a metal sulfide color-changing component, use a metal compound or a metal salt, sulfur powder or organic sulfur as a sulfur source, and after pressure steam sterilization, the two components are subjected to chemical reaction with the assistance of other auxiliaries to generate a metal sulfide with a darker color. However, the chemical indicator can be in direct contact with medical instruments during use, and heavy metal components in the indicator can inevitably contaminate wounds of patients who are operated, so that the indicator using the heavy metal formula has the risk of foreign body infection after operation.
Disclosure of Invention
In order to solve the above problems, the present invention provides a bismuth (III) compound. The steam sterilization chemical indication ink has simple and easy monitoring method, can prepare any color, has visual and accurate result, and is adhered with a layer of high-temperature resistant polishing oil after the printing of the ink is finished, wherein the polishing oil comprises the following components: maleic acid rosin ester. The problems that after sterilization, the chemical indicating ink is used for feathering and dyeing, and ink is dropped to pollute instruments can be avoided. The sterilization agent is nontoxic and harmless, can avoid the harm of heavy metal, and meets different sterilization temperature requirements; the invention also provides a preparation method and application thereof.
In order to achieve the purpose, the invention adopts the following technical scheme:
the invention provides an indicating ink for pressure steam sterilization, which comprises the following raw materials in parts by weight: 5-20% of connecting material, 10-40% of reaction factor bismuth compound, 10-30% of sulfur compound, 5-10% of resistance adjusting factor and 40-60% of diluent, wherein the sum of the percentages of the raw materials is 100%.
The invention provides a pressure steam sterilization lead-free indicator, which can be used for indicating whether a product is sterilized or not and providing a lead-free environment for medical workers, wherein the color of the indicator ink can be changed after sterilization.
In a second aspect of the present invention, there is provided a method for preparing a pressure steam sterilization indicating ink, comprising:
adding the diluent, the binder, the color factor and the resistance adjusting factor into the ink, uniformly mixing, grinding for 4-5h to obtain the ink, printing, polishing with varnish, and drying to obtain the ink.
In a third aspect of the present invention, there is provided a method for using the above-mentioned pressure steam sterilization indicating ink, comprising:
placing the indicator card in the middle of the package of the object to be sterilized; carrying out sterilization operation, taking out the indicator card after the sterilization is finished, and observing the color change of the indicator part;
if the color of the indicator part of the indicator card reaches or is darker than the standard black color, the indicator card indicates that the sterilized article meets the sterilization required condition; if the indicator portion does not change color or is lighter than "standard black," it indicates that the sterilized article is "not satisfactory for sterilization".
The indicator can be used for gravure or silk screen printing plates, and can also be made into sterilization chemical detection products in special forms such as indicator cards, indicator labels, indicator tapes and the like. The sterilization process of the instruments can be visually observed by hospitals and users by using the packaging material or the detection product printed by the indicator, the sterilization quality of each sterilized object can be monitored, and medical supplies or instruments which are not sterilized or are unqualified in sterilization are effectively prevented from being used for patients.
The invention has the advantages of
(1) The chemical indicator does not contain heavy metal lead, thereby avoiding lead exposure of hospital personnel, providing a lead-free environment and avoiding environmental pollution.
(2) By adjusting the combination of the components of the printing ink, the requirements of different sterilization temperature requirements can be met, and the standard of sterilization application in hospitals can be reached.
(3) The chemical indicator provided by the invention has the qualified rate of 100% according to the relevant regulations of four types of indicators in GB 18282.1. After high-temperature pressure steam sterilization, the color development effect is observed, and the indication ink is coated with gloss oil (maleic acid rosin ester), does not bleed, dye or drop, and does not cause ink flow to pollute medical instruments. Can not pollute the sterilized articles and can not cause harm to human bodies. Meanwhile, the chemical indicator has the effective period of 12 months.
(4) The preparation method is simple, strong in practicability and easy to popularize.
Drawings
The accompanying drawings, which are incorporated in and constitute a part of this specification, are included to provide a further understanding of the invention, and are incorporated in and constitute a part of this specification, illustrate exemplary embodiments of the invention and together with the description serve to explain the invention and not to limit the invention.
Fig. 1 is a third party test report according to embodiment 1 of the present invention.
Detailed Description
It is to be understood that the following detailed description is exemplary and is intended to provide further explanation of the invention as claimed. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.
A pressure steam sterilization indicating ink which solves the above-mentioned problems of the background art.
In order to achieve the purpose, the invention is realized by the following technical scheme: the material is prepared from the following materials in parts by weight: the material is prepared from the following materials in parts by weight: 5-20% of connecting material, 10-40% of reaction factor bismuth compound, 10-30% of resistance regulating factor of sulfur compound, 5-10% of resistance regulating factor and 40-60% of diluent.
Further, the connecting material is one or more of polyethylene resin, polyvinyl chloride resin, acrylate resin and polyamide resin. And various derivatives of cellulose.
Further, the reaction factor is bismuth salt compound selected from bismuth (III) oxide and bismuth subcarbonate. The bismuth (III) compound is one or more of bismuth subsalicylate, bismuth acetate, bismuth citrate, bismuth potassium citrate, bismuth lactate, bismuth oxalate, bismuth benzoate, bismuth tartrate, bismuth sodium tartrate and bismuth potassium tartrate. The sulfur compound is one or more of sulfur, iron sulfide, sodium sulfide and potassium sulfide.
Further, the resistance regulating factor is at least two of sodium oxide, potassium oxide, calcium oxide and lithium oxide. The amount of resistance adjustment factor is the main component controlling the reaction rate and the amount of product. The resistance adjusting factor adjusts the black and light development of the ink by adjusting the addition amount and the composition of the resistance adjusting factor, and is a key factor influencing the color change degree.
Further, the diluent is alcohol, ester, ketone and aromatic hydrocarbon. In certain embodiments, the solvent is selected from the group consisting of n-propyl acetate, n-propanol, methanol, ethanol, butyl acetate, n-butanol, cyclohexanone, and combinations thereof.
A preparation method of the pressure steam sterilization indicating ink is characterized by comprising the following steps:
s1, weighing raw materials according to 100g of production, dissolving 10-12g of connecting material by using 40-45g of diluent, and stirring until the connecting material is completely dissolved to obtain a first mixed solution.
And S2, adding 30-35g of bismuth salt compound into the first mixed solution obtained in the operation step S1, and uniformly stirring to obtain a second mixed solution.
And S3, adding 10-12g of sulfur compound into the second mixed solution obtained in the step S2, uniformly stirring, and stirring for 10min to obtain a third mixed solution.
And S4, sequentially adding 5.0-10g of resistance adjusting factors into the third mixed solution obtained in the step S3, and stirring for 10min. And (4) grinding for 4-5h by a machine.
And S5, printing and drying.
And S6, polishing oil on a polishing machine and drying.
And S7, color development and inspection are qualified.
And S8, cutting and packaging.
The present invention is described in further detail below with reference to specific examples, which are intended to be illustrative of the invention and not limiting.
The invention provides a technical scheme that: the pressure steam sterilizing indicating ink consists of connecting material 5-20 wt%, reaction factor bismuth compound 10-40 wt%, sulfur compound 10-30 wt%, resistance regulating factor 5-10 wt% and diluent 40-60 wt%.
The connecting material is one or more of polyethylene resin, polyvinyl chloride resin, acrylate resin and polyamide resin. And various derivatives of cellulose. Serving as an ink printing connection to the cardboard.
The reaction factor is bismuth salt compound selected from bismuth oxide (III) and bismuth subcarbonate. The bismuth (III) compound is one or more of bismuth subsalicylate, bismuth acetate, bismuth citrate, bismuth potassium citrate, bismuth lactate, bismuth oxalate, bismuth benzoate, bismuth tartrate, bismuth sodium tartrate and bismuth potassium tartrate. The sulfur compound is one or more of sulfur, iron sulfide, sodium sulfide and potassium sulfide. The bismuth compound and the sulfur compound react under the participation of water vapor to generate a bismuth sulfide black compound.
The resistance regulating factor is at least two of sodium oxide, potassium oxide, calcium oxide and lithium oxide. The reaction speed is adjusted by adding an anti-microbial regulating factor, and the color development depth at different time and temperature is met.
The diluent is alcohol, ester, ketone and aromatic hydrocarbon. In certain embodiments, the solvent is selected from the group consisting of n-propyl acetate, n-propanol, methanol, ethanol, butyl acetate, n-butanol, toluene, cyclohexanone, and combinations thereof. The diluent dissolves the binder, making the system a uniform ink system.
A method for preparing an indicating ink for pressure steam sterilization comprises the following specific steps:
example 1
S1, weighing 100g of raw materials according to production, dissolving 20g of acrylate resin (U.S. DuPont EAA2002 ethylene acrylate resin) by using 40g of diluent butyl acetate, and stirring until the raw materials are completely dissolved to obtain a first mixed solution.
And S2, adding 20g of bismuth tartrate into the first mixed solution obtained in the operation step S1 to obtain a second mixed solution.
And S3, adding 10g of sodium sulfide into the second mixed solution obtained in the step S2, and stirring for 10min to obtain a third mixed solution.
S4, sequentially adding 8g of sodium oxide and 2g of lithium oxide into the third mixed solution obtained in the operation step S3; and (4) stirring uniformly.
And S5, screen printing with the thickness of 1-3 threads and drying.
S6, polishing oil of a polishing machine with 30% of maleic acid rosin ester, controlling the thickness of 2-5 wires by screen printing, partially polishing printing ink, and drying at 60-80 ℃.
And S7, color development and inspection are qualified.
And S8, cutting and packaging.
Example 2
S1, weighing 100g of raw materials according to production, dissolving 10g of ethyl cellulose and 10g of nitrocellulose in 20g of diluent toluene and 10g of cyclohexanone, and stirring until the ethyl cellulose and the nitrocellulose are completely dissolved to obtain a first mixed solution.
And S2, adding 20g of bismuth salicylate into the first mixed solution obtained in the step S1 to obtain a second mixed solution.
And S3, adding 20g of potassium sulfide into the second mixed solution obtained in the step S2, and stirring for 10min to obtain a third mixed solution.
And S4, sequentially adding 8g of potassium oxide and 2g of calcium oxide into the third mixed solution obtained in the operation step S3, and uniformly stirring.
And S5, printing and drying.
S6, polishing oil of a polishing machine with 30% of maleic acid rosin ester, controlling the thickness of 2-5 wires by screen printing, partially polishing printing ink, and drying at 60-80 ℃.
And S7, color development and inspection are qualified.
And S8, cutting and packaging.
Comparative example 1
The difference from example 1 is that no varnish (rosin maleate) was used.
Comparative example 2
The difference from example 1 is that the resistance adjustment was performed without adding a resistance adjustment factor.
Comparative example 3
The difference from example 1 is that sodium carbonate is added for resistance adjustment.
The detection is carried out according to the requirements of four types of indicators in GB18282.1, and the effects are shown in Table 1:
TABLE 1
Therefore, after the chemical indicator is used and detected by a pressure steam resistance detection instrument at 132 ℃ for 4min, the indicator reaches standard black; after a steam sterilization process at 130 ℃ for 3min, the indicator did not reach the standard black color. The color development distinction degree is obvious. Meets the relevant regulations of the four indicators in GB 18282.1.
After high-temperature pressure steam sterilization, the color development effect is observed, and the indication ink is coated with gloss oil, does not bleed, is not dyed, does not drop ink, and does not flow to pollute medical instruments. Can not pollute the sterilized articles and can not cause harm to human bodies.
The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention, and various modifications and changes may be made by those skilled in the art. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.
Claims (10)
1. The pressure steam sterilization indicating ink is characterized by comprising the following raw materials in parts by weight: 5-20% of connecting material, 10-40% of reaction factor bismuth compound, 10-30% of sulfur compound, 5-10% of resistance regulating factor and 40-60% of diluent, wherein the sum of the percentages of the raw materials is 100%.
2. The pressure steam sterilization indicating ink of claim 1, wherein the binder is at least one of acrylate and methacrylate polymers, poly (vinyl acetate) and poly (vinyl chloride) and copolymers thereof, polyethylene resins, polyvinyl chloride resins, acrylate resins, polyamide resins, various derivatives of cellulose.
3. The pressure steam sterilization indicating ink of claim 1, wherein the reaction factor is a bismuth salt compound selected from bismuth (III) oxide or bismuth subcarbonate.
4. The pressure steam sterilization indicator ink of claim 1, wherein the bismuth (III) compound is at least one of bismuth subsalicylate, bismuth acetate, bismuth citrate, bismuth potassium citrate, bismuth lactate, bismuth oxalate, bismuth benzoate, bismuth tartrate, bismuth sodium tartrate, and bismuth potassium tartrate.
5. The indication ink for pressure steam sterilization as defined in claim 1, wherein the sulfur compound is at least one of elemental sulfur, ferrous sulfide, sodium sulfide, potassium sulfide.
6. The pressure steam sterilization indicator ink of claim 1, wherein the resistance modifier is at least two of sodium oxide, potassium oxide, calcium oxide, and lithium oxide.
7. The pressure steam sterilization indicating ink of claim 1, wherein the diluent is at least one of an alcohol, an ester, a ketone, and an aromatic hydrocarbon.
8. The pressure steam sterilization indicating ink of claim 1, wherein the solvent is selected from at least one of n-propyl acetate, n-propanol, methanol, ethanol, butyl acetate, n-butanol, cyclohexanone.
9. A method of making a pressure steam sterilization indicating ink, comprising:
adding the diluent, the binder, the color-developing factor and the resistance-adjusting factor into the ink, uniformly mixing, grinding for 4-5h to obtain the ink, printing, polishing with oil, and drying to obtain the ink.
10. A method of using the pressure steam sterilization indicator ink of any one of claims 1-8, comprising:
placing the indicator card in the middle of a package of articles to be sterilized; carrying out sterilization operation, taking out the indicator card after the sterilization is finished, and observing the color change of the indicator part;
if the color of the indicator part of the indicator card reaches or is deeper than the standard black color, the indicator card indicates that the sterilized article meets the sterilization required condition; if the indicator portion does not change color or is lighter than "standard black," it indicates that the sterilized article is "not satisfactory for sterilization".
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Cited By (1)
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CN116704874A (en) * | 2023-08-07 | 2023-09-05 | 山东新华医疗器械股份有限公司 | Chemical indicator and preparation method thereof |
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US20140370604A1 (en) * | 2011-12-20 | 2014-12-18 | 3M Innovative Properties Company | Water-based sterilization indicator composition |
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US5916816A (en) * | 1996-09-27 | 1999-06-29 | Minnesota Mining And Manufacturing Company | Steam sterilization indicator compositions |
US20110275159A1 (en) * | 2008-12-31 | 2011-11-10 | 3M Innovative Properties Company | Chemical indicator composition, indicators and methods |
US20140370604A1 (en) * | 2011-12-20 | 2014-12-18 | 3M Innovative Properties Company | Water-based sterilization indicator composition |
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Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
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CN116704874A (en) * | 2023-08-07 | 2023-09-05 | 山东新华医疗器械股份有限公司 | Chemical indicator and preparation method thereof |
CN116704874B (en) * | 2023-08-07 | 2023-10-20 | 山东新华医疗器械股份有限公司 | Chemical indicator and preparation method thereof |
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