Medical sterile ultrasonic coupling agent and preparation method thereof

Abstract

The invention relates to the technical field of medical coupling agents, and discloses a medical sterile ultrasonic coupling agent which comprises the following components: carbomer, a humectant, a quaternary ammonium salt disinfectant, a preservative, a pH regulator and purified water. A preparation method of the medical sterile ultrasonic coupling agent comprises the following steps: step 1, dispersing the carbomer in part of purified water, stirring until the carbomer is completely swelled, adding the preservative and the pH regulator, and continuously stirring for 20 minutes; step 2, dissolving a quaternary ammonium salt disinfectant and a humectant in the residual purified water, uniformly mixing, adding into the gel in the step 1, and vacuumizing and stirring for 10 minutes; and step 3, performing irradiation sterilization after filling to obtain a finished product. Compared with the prior art, the invention has the advantages that: the quaternary ammonium salt is used for replacing triclosan, so that skin irritation and environmental pollution are avoided, and the safety is high. A solubilizer is not needed, and the production process is simplified. According to the invention, the compatibility problem of quaternary ammonium salt and carbomer is solved through a special process, and the stability and viscosity of the product are ensured.

Description

Technical Field

[0001] This invention relates to the field of medical coupling agent technology, specifically to a sterile medical ultrasound coupling agent and its preparation method. Background Technology

[0002] Modern medical ultrasound examinations require the use of coupling gels. To avoid cross-infection when using coupling gels, disinfectant coupling gels have emerged on the market. These coupling gels use carbomer gel as a base and add triclosan as a disinfectant to disinfect the ultrasound probe and the patient's skin, reducing the risk of infection. Currently, the vast majority of sterile or non-sterile disinfectant ultrasound coupling gels on the market use triclosan as a disinfectant.

[0003] However, recent scientific research indicates that triclosan poses risks such as skin irritation, sensitization, endocrine disruption, carcinogenicity, and teratogenicity. Triclosan has poor water solubility, requiring the addition of solubilizers to dissolve it in carbomer gels. The addition of solubilizers complicates the process and increases the risk of skin irritation and allergies. Summary of the Invention

[0004] The technical problem to be solved by the present invention is to overcome the above-mentioned technical difficulties and provide a medical sterile ultrasound coupling agent and its preparation method, which uses quaternary ammonium salt to replace triclosan as a disinfectant, and at the same time solves the compatibility problem between quaternary ammonium salt and carbomer.

[0005] To solve the above-mentioned technical problems, the technical solution provided by the present invention is as follows:

[0006] A sterile medical ultrasound coupling agent comprises the following components: carbomer, humectant, quaternary ammonium salt disinfectant, preservative, pH adjuster, and purified water.

[0007] Furthermore, the medical sterile ultrasound coupling agent comprises the following components in parts by weight: 0.1-1% carbomer, 1-10% humectant, 0.01-0.5% quaternary ammonium salt disinfectant, 0.01-0.5% preservative, 0.1-1% pH adjuster, and the remainder purified water.

[0008] Furthermore, the carbomer includes, but is not limited to, carbomers 934, 940, 941, 970, 980, 2020, and U20.

[0009] Furthermore, the moisturizer is an alcohol-based moisturizer, including but not limited to: glycerin, propylene glycol, polyethylene glycol, and sorbitol.

[0010] Furthermore, the quaternary ammonium salt disinfectant is a single-chain, double-chain, or compound quaternary ammonium salt, including but not limited to: benzalkonium chloride, benzalkonium bromide, dialcyldimethylammonium chloride, dialcyldimethylammonium bromide, and the quaternary ammonium salt disinfectant is one or more of the above components in combination.

[0011] Furthermore, the preservatives include, but are not limited to, potassium sorbate, sodium benzoate, phenoxyethanol, and parabens.

[0012] Furthermore, the pH adjuster includes, but is not limited to, triethanolamine, sodium hydroxide, potassium hydroxide, alkaline inorganic or organic salts.

[0013] A method for preparing the aforementioned sterile medical ultrasound coupling agent, the preparation method is as follows:

[0014] Step 1: Disperse carbomer in a portion of purified water, stir until fully swollen, add preservative and pH adjuster, and continue stirring for 20 minutes;

[0015] Step 2: Dissolve the quaternary ammonium salt disinfectant and humectant in the remaining purified water, mix well, and then add to the gel from Step 1. Stir under vacuum for 10 minutes.

[0016] Step 3: After filling, the product is sterilized by irradiation to obtain the finished product.

[0017] It is worth mentioning that:

[0018] Purified water should comply with the requirements of the Chinese Pharmacopoeia.

[0019] Quaternary ammonium salt disinfectants are gentle on human skin, have excellent disinfection effects, are easily degradable, and are environmentally friendly. They are often formulated into solutions for cleaning and disinfecting skin, wounds, and object surfaces, such as benzalkonium chloride, chlorhexidine, and disinfectant wipes. This invention uses a quaternary ammonium salt disinfectant to replace triclosan in the disinfection coupling agent. Because quaternary ammonium salts are highly soluble, no solubilizer is needed, simplifying the production process. At the same time, the basic functions of the ultrasonic coupling agent are preserved, significantly reducing the harm of triclosan to humans and improving the disinfection effect.

[0020] Because carbomer is an anionic polymer and quaternary ammonium salts are cationic disinfectants, similar manufacturers have encountered problems such as flocculation, precipitation, and reduced viscosity when mixing these two raw materials due to technical issues, resulting in incomplete product formation. This invention solves these problems by selecting appropriate raw material types and employing a specialized process.

[0021] The advantages of this invention compared to the prior art are:

[0022] 1. This invention uses quaternary ammonium salts instead of triclosan, avoiding skin irritation and environmental pollution, and is highly safe.

[0023] 2. This invention eliminates the need for a solubilizer, simplifying the production process.

[0024] 3. This invention solves the compatibility problem between quaternary ammonium salts and carbomer through a special process, ensuring product stability and viscosity.

[0025] 4. This invention ensures the sterility of the product by using irradiation sterilization. Detailed Implementation

[0026] In the description of this invention, it should be understood that, unless otherwise stated, "a plurality of" means two or more. Furthermore, the term "comprising" and any variations thereof are intended to cover non-exclusive inclusion.

[0027] The present invention will now be described in further detail with reference to the embodiments.

[0028] In specific implementation of the embodiments of the present invention:

[0029] Example 1

[0030] A sterile medical ultrasound coupling agent comprises the following components in parts by weight: 0.5% carbomer 980, 5% glycerol, 3% propylene glycol, 0.1% benzalkonium chloride, 0.1% decyl dimethyl ammonium chloride, 0.2% phenoxyethanol, 0.5% triethanolamine, and 90.6% purified water.

[0031] The carbomer includes, but is not limited to, carbomer 934, 940, 941, 970, 980, 2020, and U20. The humectant is an alcohol-based humectant, including, but not limited to, glycerin, propylene glycol, polyethylene glycol, and sorbitol. The quaternary ammonium salt disinfectant is a single-chain, double-chain, or compound quaternary ammonium salt, including, but not limited to, benzalkonium chloride, benzalkonium bromide, dialcyldimethylammonium chloride, dialcyldimethylammonium bromide, or a combination of one or more of the above components. The preservative includes, but is not limited to, potassium sorbate, sodium benzoate, phenoxyethanol, and parabens. The pH adjuster includes, but is not limited to, triethanolamine, sodium hydroxide, potassium hydroxide, and alkaline inorganic or organic salts.

[0032] A method for preparing the aforementioned sterile medical ultrasound coupling agent, the preparation method is as follows:

[0033] Step 1: Disperse Carbomer 980 in 40% purified water, swell it, then add phenoxyethanol and triethanolamine, and stir for 20 minutes;

[0034] Step 2: Dissolve benzalkonium chloride, disdecyldimethylammonium chloride, glycerol, and propylene glycol in the remaining purified water, add them to the gel from Step 1, and stir under vacuum for 10 minutes;

[0035] Step 3: After filling, the mixture is sterilized by gamma ray irradiation to obtain a sterile coupling agent.

[0036] Example 2

[0037] A sterile medical ultrasound coupling agent comprises the following components in parts by weight: Carbomer 980: 0.3%, Glycerin: 6%, Polyethylene Glycol 400: 2%, Benzalkonium Bromide: 0.15%, Didecyl Dimethyl Ammonium Bromide: 0.05%, Phenoxyethanol: 0.1%, Triethanolamine: 0.4%, and Purified Water: Balance to 100%.

[0038] A method for preparing the aforementioned sterile medical ultrasound coupling agent, the preparation method is as follows:

[0039] Step 1: Disperse Carbomer 980 in 30% purified water and stir until completely swollen. Add phenoxyethanol and triethanolamine and continue stirring for 20 minutes.

[0040] Step 2: Dissolve benzalkonium bromide, dicedyldimethylammonium bromide, glycerol, and polyethylene glycol 400 in the remaining purified water, mix well, and slowly add to the gel from Step 1. Stir under vacuum for 10 minutes.

[0041] Step 3: Fill the tubes into sterile packaging tubes and sterilize them by gamma ray irradiation to obtain the finished product.

[0042] Example 3

[0043] A sterile medical ultrasound coupling agent comprises the following components in parts by weight: Carbomer 940: 0.8%, Sorbitol: 4%, Propylene Glycol: 5%, Didecyl Dimethyl Ammonium Chloride: 0.2%, Benzalkonium Chloride: 0.1%, Methylparaben: 0.15%, Sodium Hydroxide: 0.3%, and Purified Water: Balance to 100%.

[0044] A method for preparing the aforementioned sterile medical ultrasound coupling agent, the preparation method is as follows:

[0045] Step 1: Disperse Carbomer 940 in 50% purified water, let it stand and swell, then add methylparaben and sodium hydroxide solution, and stir for 30 minutes until a uniform gel is formed;

[0046] Step 2: Dissolve decyl dimethyl ammonium chloride, benzalkonium chloride, sorbitol, and propylene glycol in the remaining purified water, heat to 40°C to promote dissolution, cool, add to the gel from Step 1, and vacuum degas and stir for 15 minutes.

[0047] Step 3: After filling, the mixture is sterilized by electron beam irradiation (dose 15kGy) to obtain a high-viscosity coupling agent.

[0048] The present invention and its embodiments have been described above, and this description is not restrictive. If those skilled in the art are inspired by this description and design similar embodiments without departing from the spirit of the invention, such embodiments should fall within the protection scope of the present invention.

Claims

1. A sterile medical ultrasound coupling agent, characterized in that, It includes the following components: carbomer, humectant, quaternary ammonium salt disinfectant, preservative, pH adjuster, and purified water.

2. The medical sterile ultrasound coupling agent according to claim 1, characterized in that, It includes the following components by weight: 0.1-1% carbomer, 1-10% humectant, 0.01-0.5% quaternary ammonium disinfectant, 0.01-0.5% preservative, 0.1-1% pH adjuster, and the remainder purified water.

3. The medical sterile ultrasound coupling agent according to claim 2, characterized in that: The carbomers include, but are not limited to, carbomers 934, 940, 941, 970, 980, 2020, and U20.

4. The medical sterile ultrasound coupling agent according to claim 2, characterized in that: The moisturizer is an alcohol-based moisturizer, including but not limited to: glycerin, propylene glycol, polyethylene glycol, and sorbitol.

5. The medical sterile ultrasound coupling agent according to claim 2, characterized in that: The quaternary ammonium salt disinfectant is a single-chain, double-chain, or compound quaternary ammonium salt, including but not limited to: benzalkonium chloride, benzalkonium bromide, dialcyldimethylammonium chloride, dialcyldimethylammonium bromide, and the quaternary ammonium salt disinfectant is one or more of the above components.

6. The medical sterile ultrasound coupling agent according to claim 2, characterized in that: The preservatives include, but are not limited to, potassium sorbate, sodium benzoate, phenoxyethanol, and parabens.

7. The medical sterile ultrasound coupling agent according to claim 2, characterized in that: The pH adjuster includes, but is not limited to, triethanolamine, sodium hydroxide, potassium hydroxide, and alkaline inorganic or organic salts.

8. A method for preparing a sterile medical ultrasound coupling agent according to any one of claims 1 to 7, characterized in that, The preparation method is as follows: Carbomer is swollen and mixed with a quaternary ammonium salt solution, then filled and sterilized by irradiation to obtain a sterile medical ultrasound coupling agent.