阅读说明：本技术 一种制备医用超声耦合剂无菌产品可安全使用的方法 (method for preparing medical ultrasonic coupling agent sterile product capable of being safely used ) 是由 袁国正 张爱辉 喻晓兰 李凤秀 于 2019-09-05 设计创作，主要内容包括：本发明公开了一种制备医用超声耦合剂无菌产品可安全使用的方法,包括如下步骤：S1.将未经灭菌的医用超声耦合剂料装入不锈钢桶内,蒸汽灭菌；所述的医用超声耦合剂料的配方如下：卡波姆0.5-1.5％；丙二醇3-5％；丙三醇1-3％；三乙醇胺1-2％；纯净水余量；S2.灭菌后,医用超声耦合剂料降温至25℃～80℃进行包装,包装袋为铝复合膜包装袋；所述铝复合膜包装袋为四层膜结构,所述四层膜由外而内依次为聚酯层、铝箔层、聚酰胺或凯夫拉层、聚乙烯或聚丙烯层；S3.包装完成后终端热力灭菌。为了方便手术台使用,普通无菌产品的铝复合膜包装袋再套一层特制的纸塑袋再进行一次灭菌。本发明技术方案与其它方法相比操作简单、产品质量好,生产成本低。(The invention discloses a method for preparing a medical ultrasonic coupling agent sterile product which can be safely used, and the method comprises the following steps: s1, filling an unsterilized medical ultrasonic coupling agent material into a stainless steel barrel, and performing steam sterilization; the formula of the medical ultrasonic coupling agent is as follows: carbomer 0.5-1.5%; 3-5% of propylene glycol; 1-3% of glycerol; 1-2% of triethanolamine; the balance of purified water; s2, after sterilization, cooling the medical ultrasonic coupling agent material to 25-80 ℃ for packaging, wherein the packaging bag is an aluminum composite film packaging bag; the aluminum composite film packaging bag is of a four-layer film structure, and the four-layer film sequentially comprises a polyester layer, an aluminum foil layer, a polyamide or Kevlar layer and a polyethylene or polypropylene layer from outside to inside; and S3, performing terminal thermal sterilization after packaging is completed. In order to facilitate the use of the operating table, a layer of special paper-plastic bag is sleeved on an aluminum composite film packaging bag of a common sterile product, and then the aluminum composite film packaging bag is sterilized once. Compared with other methods, the technical scheme of the invention has the advantages of simple operation, good product quality and low production cost.)

1. A method for preparing a medical ultrasonic couplant sterile product which can be safely used is characterized by comprising the following steps:

S1, filling an unsterilized medical ultrasonic coupling agent material into a stainless steel barrel, and placing the stainless steel barrel into a steam sterilization device with the pressure of 0.14-0.22 Mpa for sterilization; the formula of the medical ultrasonic coupling agent comprises the following components in percentage by weight: carbomer 0.5-1.5%; 3-5% of propylene glycol; 1-3% of glycerol; 1-2% of triethanolamine; the balance of purified water;

S2, after sterilization, cooling the medical ultrasonic coupling agent to 25-80 ℃ for packaging, wherein the packaging bag is an aluminum composite film packaging bag; the aluminum composite film is of a four-layer film structure, and the four-layer film sequentially comprises a polyester layer, an aluminum foil layer, a polyamide or Kevlar layer and a polyethylene or polypropylene layer from outside to inside;

And S3, performing terminal thermal sterilization after packaging is completed.

2. The method for preparing the medical ultrasonic couplant sterile product safe to use as claimed in claim 1, wherein the steps further comprise the steps of sleeving a layer of paper-plastic bag on the outer layer of the packaging bag after terminal thermal sterilization, and then sterilizing; the sterilization method of the paper-plastic bag is thermal sterilization or ethylene oxide gas sterilization.

3. The method for preparing a medical ultrasonic couplant sterile product safe to use according to claim 1 or 2, wherein steam temperature for sterilization of S1 is 121 ℃ to 134 ℃ for 20 minutes.

4. The method for preparing a medical ultrasonic couplant sterile product safe to use according to claim 1 or 2, wherein the terminal thermal sterilization operation S3 is to put the packaged medical ultrasonic couplant into a sterilization device and sterilize at 124-126 ℃ for 4.0-6.5 min.

5. the method for preparing a medical ultrasonic couplant sterile product safe to use according to claim 1, wherein the polyester layer is 12um thick, the aluminum foil layer is 9um thick, the polyamide or kevlar layer is 20um thick, and the polyethylene or polypropylene layer is 12um thick.

6. The method for preparing a medical ultrasonic couplant sterile product safe to use as claimed in claim 1, wherein the formulation of the medical ultrasonic couplant is as follows by weight percent: 1% of carbomer; 4% of propylene glycol; 2% of glycerol; 1.5 percent of triethanolamine; 91.5 percent of purified water; the carbomer, the propylene glycol and the glycerol are all of pharmaceutical grade, the triethanolamine is chemically pure, and the purified water is water and is obtained by filtering through a reverse osmosis membrane.

7. The method for preparing a sterile product of medical ultrasound couplant for safe use according to claim 6, wherein the preparation method of the medical ultrasound couplant is as follows: dissolving carbomer with purified water, adding triethanolamine to neutralize until the pH value of the solution is 6.5-7.2, adding the humectants propylene glycol and glycerol, stirring uniformly, and removing bubbles in vacuum to obtain the carbomer.

8. the method for preparing a sterile product of medical ultrasonic couplant for safe use according to claim 1, wherein said packaging of S2 is performed by a domestic general type DC-338-3 high-speed packaging machine; the four-layer film comprises a polyester layer, an aluminum foil layer, a polyamide layer and a polypropylene layer from outside to inside in sequence.

9. the method for preparing the medical ultrasonic couplant sterile product safe to use as claimed in claim 8, wherein the packaging speed is 15-18 bags per minute, each bag is filled with 10-40 g of medical ultrasonic couplant, and the packaging bag is heat-sealed by four sides.

10. The sterile product of medical ultrasound couplant obtained by the method for preparing the sterile product of medical ultrasound couplant safe for use according to any one of claims 1-9.

Technical Field

The invention relates to the field of sterilization of medical ultrasonic coupling agents, in particular to a thermal sterilization method for preparing a medical ultrasonic coupling agent sterile product which can be safely used.

background

The medical ultrasonic couplant is a gel preparation used for ultrasonic examination of human body, and is aimed at eliminating air between ultrasonic probe and examined position of human body, and strengthening coupling between ultrasonic probe and examined position so as to make sound wave conduction be not attenuated by air influence to obtain reliable detection result. At present, the ultrasonic wave propagation medium used for cavity, puncture operation and the like must use a medical ultrasonic couplant sterile product, so that bacteria infection in the diagnosis and operation process can be avoided.

When the product is not available in the market in the past, medical institutions can only contain the common couplant in a vessel and sterilize in a steam pressure boiler, after sterilization is finished, the couplant is cooled and sent to an operating room for use, and the unused sterilized couplant cannot be reserved for use so as to avoid infection. The appearance of small-package medical ultrasonic coupling agent sterile products brings great convenience to ultrasonic treatment operations. Currently, manufacturers adopt a cobalt 60 irradiation sterilization method to produce aseptic products of medical ultrasonic couplants. Publication No. CN106729775A discloses a sterile medical ultrasonic couplant for a cavity and a preparation method thereof, which comprises the following components in parts by weight: 0.5-2 parts of carbomer; 0.05-0.3 part of vitamin E; 3 parts of zedoary turmeric oil; 0.5-2.5 parts of an antibacterial agent; 1-3.5 parts of triethanolamine; 10-22 parts of a wetting agent; 200-300 parts of purified water. The preparation method comprises the following steps: uniformly dispersing carbomer in an antibacterial agent and a wetting agent, adding 2/3 weight of purified water, stirring for swelling, adding the rest 1/3 weight of purified water, uniformly mixing, adding vitamin E and zedoary turmeric oil, uniformly mixing, adding triethanolamine, uniformly stirring, filling and sealing, and performing cobalt 60 irradiation sterilization to obtain the product. According to the technical scheme, the cobalt 60 irradiation is adopted for sterilization, and the cobalt 60 irradiation equipment is constructed, so that a plurality of environmental risks exist and the cost is high in the aspects of site selection, construction cost, technical training of operators, production management and the like. In addition, the cobalt 60 processing medical ultrasonic couplant has quality risk, and medical supplies which can be sterilized by irradiation are regulated in 13 types abroad, and more than 140 types are provided in total, but the cobalt 60 processing medical ultrasonic couplant does not comprise materials containing water components. Because the free radicals of the water molecules dissociated by the radiation of the cobalt 60 can cause the chemical substances in the ultrasonic couplant to generate a cracking reaction, the viscosity of the couplant is reduced.

A complete set of sterilization packaging equipment has been developed abroad for many years, and the plastic bag sterile packaging equipment takes Brilliant bags of DuPont Canada and FPS-2000LL plastic bag sterile packaging devices of Elecster Finland as examples, packaging films are subjected to 10% hydrogen peroxide immersion sterilization and residual liquid scraping, then are subjected to strong irradiation sterilization by ultraviolet lamp chambers (5 ultraviolet lamps at the upper part and 40 ultraviolet lamps at the lower part and 13 ultraviolet lamps at the lower part and 15W ultraviolet lamps at the lower part), then are introduced into a former to fold the packaging films into angles, and are subjected to longitudinal heat sealing, filling, transverse sealing cutting and printing to complete product packaging. Sterile air is obtained through high-temperature steam sterilization and a special filter cylinder, the sterile air is introduced into the sterile package and then divided into two paths, one path of sterile air is sent into an ultraviolet lamp sterilization chamber, the other path of sterile air is sent into the upper part of a filling chamber and is sprayed out from a nozzle under the pressure of 0.15-0.2 Mpa, the sterile air in the ultraviolet lamp chamber, a film cylinder opening and a filling sealing chamber is kept to be rapidly heated and sterilized by an overpressure heater, the temperature of the sterile air is kept for a period of time by a retainer, and then the sterile air is cooled to room temperature. The aseptic packaging machine has strict sterilization, complex process and high operation cost, the price of the whole packaging machine is up to millions of RMB, a large amount of sterilization preparations are consumed during packaging, an aseptic production place is required, the production cost is high, and the aseptic quality of the product is not easy to guarantee.

In view of the above situation, the method for preparing the medical ultrasonic couplant sterile product, which is simple to operate, excellent in product quality and low in production cost, is researched, and has significant social and economic benefits.

Disclosure of Invention

Aiming at the defects in the prior art, the invention aims to provide a method for preparing a medical ultrasonic couplant sterile product which can be used safely, the obtained product has excellent and stable quality and safe and reliable use, and the investment and the production cost are saved.

in order to achieve the purpose, the technical scheme provided by the invention is as follows:

A method for preparing a medical ultrasonic couplant sterile product which can be safely used comprises the following steps:

S1, filling an unsterilized medical ultrasonic coupling agent material into a stainless steel barrel, and placing the stainless steel barrel into a steam sterilization device with the pressure of 0.14-0.22 Mpa for sterilization; the formula of the medical ultrasonic coupling agent comprises the following components in percentage by weight: carbomer 0.5-1.5%; 3-5% of propylene glycol; 1-3% of glycerol; 1-2% of triethanolamine; the balance of purified water;

S2, after sterilization, cooling the medical ultrasonic coupling agent to 25-80 ℃ for packaging, wherein the packaging bag is an aluminum composite film packaging bag; the aluminum composite film is of a four-layer film structure, and the four-layer film sequentially comprises a polyester layer, an aluminum foil layer, a polyamide or Kevlar layer and a polyethylene or polypropylene layer from outside to inside;

And S3, performing terminal thermal sterilization after packaging is completed.

The carbomer is acrylic resin.

the method for preparing the medical ultrasonic coupling agent sterile product can be safely used, firstly, the formula of the medical ultrasonic coupling agent is selected, the coupling performance of the formula of the coupling agent is good, and the image is clear; the lubricating property is good, and the use is convenient; no corrosion and no damage to the probe; has no irritation, no allergy, no pollution and easy removal, and is an ideal ultrasonic coupling agent. And secondly, designing a coupling agent, performing steam high-temperature sterilization, wherein the chemical components of the product are stable and do not generate degradation reaction under the protection of steam, and then performing terminal sterilization operation after packaging by using an aluminum composite film. The selection and combination of materials of all layers of the aluminum composite film packaging bag are obtained through long-term research by the inventor, the outer layer is polyester, the middle layer is aluminum foil which is mainly used for blocking gas, illumination and microorganisms and is added with polyamide or Kevlar which plays a role in strengthening and bonding, and the innermost layer is a polyethylene or polypropylene layer. The aluminum composite film packaging bag can resist the high temperature of 125-140 ℃, and the barrier indexes such as air permeability and transmittance are basically close to zero as long as no pin hole is generated due to the bending of the aluminum foil. In the invention, the aluminum composite film packaging bag and the packaging production equipment do not need to be sterilized, and the packaging environment does not need to be sterile, thereby reducing the production cost and saving the equipment investment and construction cost.

Preferably, the steps further comprise the steps of sleeving a layer of paper-plastic bag on the outer layer of the packaging bag after terminal thermal sterilization, and then sterilizing; the sterilization method of the paper-plastic bag is thermal sterilization or ethylene oxide gas sterilization. In order to facilitate the use of the operating table, a layer of specially-made paper-plastic bag is sleeved outside the aluminum composite film packaging bag, and then the bag is sterilized once again, so that the use is convenient and the safety is high. The paper-plastic bag can be sterilized by heat or ethylene oxide gas.

Preferably, the steam temperature for sterilization in S1 is 121 ℃ to 134 ℃ for 20 minutes. Under the conditions of the steam temperature and the sterilization time, the sterilization effect is good.

Preferably, the terminal thermal sterilization operation of S3 is to put the packaged medical ultrasonic coupling agent into a sterilization device, and sterilize for 4.0-6.5 min at 124-126 ℃.

in particular, the packaging machine for bag making and filling packaging uses a non-sterile packaging common gel ordinary automatic bag making and filling material device, and the packaging machine is mainly controlled by a film drawing and folding device, a longitudinal and transverse heat sealing device and a bag cutting and printing mechanism through cursor induction. The metering of the material can be manually and coarsely adjusted and the rotating speed of the feeding screw rod can be finely adjusted, and the price of the whole packaging machine only needs tens of thousands of RMB at most.

Preferably, the thickness of the polyester layer is 12um, the thickness of the aluminum foil layer is 9um, the thickness of the polyamide or kevlar layer is 20um, and the thickness of the polyethylene or polypropylene layer is 12 um. With the above thickness, the aluminum foil does not bend to cause pinholes, and the barrier properties of the packaging bag, such as air permeability and transparency, are almost zero.

Preferably, the formulation of the medical ultrasound coupling agent comprises the following components in percentage by weight: 1% of carbomer; 4% of propylene glycol; 2% of glycerol; 1.5 percent of triethanolamine; 91.5 percent of purified water; the carbomer, the propylene glycol and the glycerol are all of pharmaceutical grade, the triethanolamine is chemically pure, and the purified water is water and is obtained by filtering through a reverse osmosis membrane. Further, the preparation method of the medical ultrasonic coupling agent comprises the following steps: dissolving carbomer with purified water, adding triethanolamine to neutralize until the pH value of the solution is 6.5-7.2, adding the humectants propylene glycol and glycerol, stirring uniformly, and removing bubbles in vacuum to obtain the carbomer. The medical ultrasonic coupling agent has a simple formula, does not need to add a preservative or a bactericide, and is mild and effective.

Specifically, the packaging of S2 adopts a domestic common type DC-338-3 high-speed packaging machine; the four-layer film comprises a polyester layer, an aluminum foil layer, a polyamide layer and a polypropylene layer from outside to inside in sequence. The packaging speed is 15-18 bags per minute, each bag is filled with 10-40 g of medical ultrasonic coupling agent, and the four sides of the packaging bag are heat-sealed. And (4) performing terminal thermal sterilization on the packaged couplant to obtain a common sterile product. Bacteria exist on the surface of the aluminum composite film of the packaging bag of the common sterile product, and the tearing opening of the common sterile product must be sterilized by 65 percent alcohol or other disinfectants before use. In order to facilitate the use of the operating table, a layer of special paper-plastic bag is sleeved on an aluminum composite film packaging bag of a common sterile product, and then the aluminum composite film packaging bag is sterilized once. The paper-plastic bag can be sterilized by heat or ethylene oxide gas.

The invention also protects the medical ultrasonic couplant sterile product obtained by the method for preparing the medical ultrasonic couplant sterile product and the application of the medical ultrasonic couplant sterile product in the aspect of medical treatment.

Compared with the prior art, the invention has the beneficial effects that:

the invention adopts a high-temperature treatment system, the sterilization temperature before packaging the coupling agent can reach 121-134 ℃, the chemical components of the coupling agent product are stable under the protection of steam in the sterilization process, the degradation reaction can not occur, and the viscosity of the coupling agent can not be reduced. The couplant product is subjected to terminal thermal sterilization after being packaged, the aluminum composite film material of the packaging bag and packaging production equipment do not need to be subjected to sterilization treatment, and the packaging environment does not need to be sterile, so that the production cost is reduced, and the equipment investment and construction cost are saved. Compared with other methods in the prior art, the method for preparing the medical ultrasonic coupling agent sterile product which can be safely used has the advantages of simple operation, good product quality, low production cost, capability of killing bacteria and bacterial spores and long sterilization period of validity of more than 10 years.

Detailed Description

In order to make the objects and advantages of the invention more concise, the invention will be described in more detail with reference to the following examples, to which it is in no way limited. The following examples are merely preferred examples of the present invention and are only illustrative of the present invention and should not be construed as limiting the scope of the present invention. It should be understood that any modification, equivalent replacement, and improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention. Therefore, the protection scope of the present invention should be subject to the appended claims.

The raw materials of the ultrasonic couplant to which the following examples apply are all commercially available.