Medical sodium hyaluronate sterile application and processing method thereof

Abstract

The invention relates to the technical field of medical dressings, in particular to a medical sodium hyaluronate sterile application and a processing method thereof.The medical sodium hyaluronate sterile application is prepared from 0.15 part of sodium hyaluronate, 0.15 part of carbomer, 3 parts of glycerin, 0.06 part of triethanolamine, 0.06 part of capryloyl hydroximic acid, 0.75 part of 1, 2-butanediol, 0.19 part of 1, 2-hexanediol and purified water.According to the medical sodium hyaluronate sterile application and the processing method thereof, the medical sodium hyaluronate sterile application can be obtained by conducting natural wetting on carbomer U21 for 10-15 min and conducting stirring at the speed of 30-35 r / min; sodium hyaluronate is dispersed in glycerol for 5-8 minutes under the assistance of 20-30kHz ultrasonic waves, so that effective components are fully dissolved, and precipitation is avoided.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical dressings, in particular to a medical sodium hyaluronate sterile dressing and a processing method thereof. BACKGROUND

[0002] In the field of medical dressings, sodium hyaluronate is widely used in wound care, postoperative repair and other scenarios due to its good moisturizing property, biocompatibility and wound healing promoting characteristics. In the preparation process of existing medical dressings, the following technical problems are often encountered: Insufficient uniformity of component dispersion: As a macromolecular substance, sodium hyaluronate is prone to aggregation if the dispersion process is not proper, which leads to uneven distribution of effective components in the dressing and affects the use effect; if the wetting and swelling process of matrix materials such as carbomer is not properly controlled, it will also cause uneven texture of the gel matrix.

[0003] Difficult to control sterility: In traditional dressing production, if the equipment material does not meet the medical standard (such as rough surface, easy to leave residue), or the filling and film sealing process precision is insufficient, it may introduce microbial contamination, which is difficult to meet the sterility requirement.

[0004] Low production process precision: The existing method lacks precise specification for parameters such as material ratio, stirring speed and temperature control, which leads to inconsistent dosage of the dressing, poor packaging sealing, and affects the stability and safety of the product. SUMMARY

[0005] The purpose of the present application is to provide a medical sodium hyaluronate sterile dressing and a processing method thereof to solve the problems raised in the background.

[0006] The technical solution of the present application is: a medical sodium hyaluronate sterile dressing and a processing method thereof, including sodium hyaluronate 0.15 parts, carbomer 0.15 parts, glycerol 3 parts, triethanolamine 0.06 parts, octanoyl hydroxamic acid 0.06 parts, 1,2-butanediol 0.75 parts, 1,2-hexanediol 0.19 parts, purified water, including the following preparation method: Step S1: about 20 parts of purified water is weighed into a stirring tank, and the actual amount of purified water is recorded.

[0007] Step S2: 25 parts of purified water is taken in a rinsing barrel for rinsing the utensils; Step S3: about 25 parts of purified water is taken in a liquid preparation barrel, and 0.15 parts of carbomer U21 is slowly and uniformly scattered on the surface of the purified water, and after natural wetting, it is stirred uniformly; Step S4: take a clean container, weigh 0.06 parts of triethanolamine, pour it into the liquid preparation barrel, rinse the container containing triethanolamine from the rinsing barrel several times, then pour it into the liquid preparation barrel, and fully stir to make it swell. And record the actual amount of triethanolamine; Step S5: adjust the stirring tank speed to 40 rpm, slowly pour the solution in the solution preparation bucket into the stirring tank, and then rinse the solution preparation bucket with purified water from the rinsing bucket in small amounts and multiple times. Step S6: take a clean container, weigh 0.75 parts of 1,2-butanediol and 0.19 parts of 1,2-hexanediol, mix them evenly, then weigh 0.06 parts of octanoyl hydroxamic acid, add it to the mixture of 1,2-butanediol and 1,2-hexanediol, heat and stir in a 50°C water bath until completely dissolved, then pour it into the stirring tank, rinse the remaining purified water in the rinsing bucket into the stirring tank in small amounts and multiple times. Record the actual amount of 1,2-butanediol, 1,2-hexanediol and octanoyl hydroxamic acid used; Step S7: take a clean container, weigh 3 parts of glycerol, then weigh 0.15 parts of sodium hyaluronate into the glycerol, mix them evenly, then pour them into the stirring tank. Record the actual amount of glycerol and sodium hyaluronate used; Step S8: calculate the total amount of all the materials used above, subtract the total amount of the materials used above from the total preparation amount of 100 parts to get the amount of purified water still needed to complete the preparation, then weigh the final amount of purified water, rinse the container in step S7 in small amounts and multiple times, and slowly pour it into the stirring tank.

[0008] Step S9: use a patch filling machine to fill, then use a plastic sealing machine to seal the film after boxing.

[0009] Preferably, the carbomer U21 has a natural wetting time of 10-15 minutes and a stirring speed of 30-35 rpm.

[0010] Preferably, when the triethanolamine container is rinsed, the amount of water used for each rinse is 1 / 3-1 / 2 of the container volume, and the number of rinses is 2-3 times.

[0011] Preferably, when the sodium hyaluronate is dispersed in glycerol, ultrasonic waves are used for auxiliary dispersion, the ultrasonic frequency is 20-30 kHz, and the dispersion time is 5-8 minutes.

[0012] Preferably, the inner walls of the stirring tank, rinsing bucket and solution preparation bucket are polished, the surface roughness Ra is ≤0.8 μm, and the material is 316L stainless steel.

[0013] Preferably, the filling precision of the patch filling machine is ±0.5 g, the sealing film temperature of the plastic sealing machine is 120-130°C, and the sealing film pressure is 0.3-0.5 MPa.

[0014] Preferably, when the 50°C water bath is heated, the stirring paddle is made of polytetrafluoroethylene, and the distance between the stirring blade and the solution preparation bucket wall is 2-3 cm The present application provides a medical sodium hyaluronate sterile dressing and its processing method by improvement, which has the following improvements and advantages compared with the prior art. The sodium hyaluronate is dispersed in glycerol by 20-30 kHz ultrasonic wave for 5-8 minutes through natural wetting for 10-15 minutes and stirring at 30-35 revolutions per minute by Carbopol U21, so as to ensure that the active ingredients are fully dissolved and avoid precipitation; The device is rinsed multiple times in the rinsing barrel containing 25 parts of purified water, so as to reduce material residues and improve raw material utilization; The stirring tank and liquid preparation barrel are made of 316L stainless steel, and the inner wall is polished to a roughness Ra≤0.8 μm, so as to reduce the risk of impurity adhesion and ensure a clean production environment; The filling precision of the dressing filling machine is ±0.5 g, the film sealing temperature of the plastic sealing machine is controlled at 120-130 °C, and the pressure is 0.3-0.5 MPa, so as to ensure accurate product dosage and good packaging sealing performance; A polytetrafluoroethylene stirring paddle is used when heated in a 50 °C water bath, and the distance between the blade and the barrel wall is 2-3 cm, so as to avoid dead angles during stirring and ensure uniformity of material mixing. BRIEF DESCRIPTION OF DRAWINGS

[0015] The present application will be further explained in conjunction with the drawings and examples: Figure 1 is a process flow chart of the dressing preparation of the present application; Figure 2 is a key process parameter control flow chart of the present application. DETAILED DESCRIPTION

[0016] The present application will be described in detail below, and the technical solutions in the embodiments of the present application will be clearly and completely described. Obviously, the described embodiments are only part of the embodiments of the present application, not all embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor belong to the scope of protection of the present application.

[0017] The present application provides a medical sodium hyaluronate sterile dressing and its processing method by improvement, and the technical solution of the present application is: As shown in Figure 1 - Figure 2 A medical sodium hyaluronate sterile dressing and its processing method, including sodium hyaluronate 0.15 parts, carbomer 0.15 parts, glycerol 3 parts, triethanolamine 0.06 parts, octanoyl hydroxamic acid 0.06 parts, 1,2-butanediol 0.75 parts, 1,2-hexanediol 0.19 parts, purified water, including the following preparation method: Step S1: about 20 parts of purified water is weighed and poured into a stirring tank, and the actual amount of purified water is recorded.

[0018] Step S2: Take 25 parts of purified water in the rinsing barrel for rinsing the utensils; Step S3: Take about 25 parts of purified water in the liquid preparation barrel, and then take 0.15 parts of carbomer U21 and evenly scatter it on the surface of the purified water. After natural wetting, stir evenly; Step S4: Take a clean container, weigh 0.06 parts of triethanolamine, pour it into the liquid preparation barrel, and then rinse the container containing triethanolamine with a small amount of purified water from the rinsing barrel several times, and then pour it into the liquid preparation barrel. Stir well to make it swell. Record the actual amount of triethanolamine used.

[0019] Step S5: Adjust the stirring speed of the stirring tank to 40 rpm, slowly pour the solution in the liquid preparation barrel into the stirring tank, and then rinse the liquid preparation barrel with a small amount of purified water from the rinsing barrel several times and pour it into the stirring tank.

[0020] Step S6: Take a clean container, weigh 0.75 parts of 1,2-butanediol and 0.19 parts of 1,2-hexanediol, mix well, then weigh 0.06 parts of octanoyl hydroxamic acid, add it to the mixture of 1,2-butanediol and 1,2-hexanediol, heat and stir in a 50°C water bath until completely dissolved, then pour it into the stirring tank. Rinse the container with the remaining purified water from the rinsing barrel several times and pour it into the stirring tank. Record the actual amount of 1,2-butanediol, 1,2-hexanediol and octanoyl hydroxamic acid used.

[0021] Step S7: Take a clean container, weigh 3 parts of glycerol, then weigh 0.15 parts of sodium hyaluronate into the glycerol, and pour it into the stirring tank after it is completely dispersed. Record the actual amount of glycerol and sodium hyaluronate used.

[0022] Step S8: Calculate the total amount of all the above materials, subtract the total amount of the above materials from the total amount of 100 parts, and get the amount of purified water needed to complete the preparation. Weigh the final amount of purified water, rinse the container in step S7 several times, and slowly pour it into the stirring tank.

[0023] Step S9: Use the patch filling machine to fill, and then use the plastic sealing machine to seal the film.

[0024] Further, the natural wetting time of the carbomer U21 is 10-15 minutes, and the stirring speed is 30-35 rpm. Limiting the natural wetting time of carbomer U21 to 10-15 minutes and the stirring speed to 30-35 rpm can ensure that the carbomer is fully swollen and dispersed, avoid gel clumping due to insufficient wetting, and ensure the uniformity of the patch matrix.

[0025] Furthermore, when rinsing the triethanolamine container, the amount of water used for each rinse is 1 / 3 to 1 / 2 of the container volume, and the rinsing is performed 2 to 3 times. Clearly defining that the amount of water used for each rinse is 1 / 3 to 1 / 2 of the container volume and the rinsing is performed 2 to 3 times can effectively reduce the material residue on the inner wall of the container, ensure the accurate addition of triethanolamine, and avoid deviations in the component ratio.

[0026] Furthermore, when the sodium hyaluronate is dispersed in glycerol, ultrasonic-assisted dispersion is used. The ultrasonic frequency is 20-30kHz, and the dispersion time is 5-8 minutes. The 20-30kHz ultrasonic-assisted dispersion of sodium hyaluronate for 5-8 minutes utilizes the ultrasonic cavitation effect to accelerate the dispersion of sodium hyaluronate in glycerol, prevent the aggregation of large molecules, and improve the dissolution efficiency of the active ingredients.

[0027] Furthermore, the inner walls of the mixing tank, rinsing tank, and dispensing tank are all polished with a surface roughness Ra≤0.8μm and are made of 316L stainless steel. The equipment is made of 316L stainless steel with an inner wall roughness Ra≤0.8μm. This material is corrosion-resistant and has a smooth surface, which can reduce the risk of material adhesion, meet the requirements of medical aseptic production, and facilitate equipment cleaning and disinfection.

[0028] Furthermore, the filling accuracy of the dressing filling machine is ±0.5g, the sealing temperature of the sealing machine is 120-130℃, and the sealing pressure is 0.3-0.5MPa. The filling accuracy of ±0.5g ensures that the dosage of the medicine in each dressing is consistent. The sealing temperature of 120-130℃ combined with the pressure of 0.3-0.5MPa can form a tight and sterile package, preventing the dressing from being contaminated by microorganisms during storage.

[0029] Furthermore, during the 50°C water bath heating, the stirring paddle is made of polytetrafluoroethylene (PTFE), and the distance between the stirring blade and the wall of the mixing tank is 2-3 cm. The use of PTFE stirring paddle during 50°C water bath heating has good temperature resistance and stable chemical properties. The 2-3 cm distance between the stirring blade and the tank wall can avoid dead zones in the stirring and ensure that components such as octanoyl hydroxamic acid are mixed evenly during heating and dissolution.

[0030] The foregoing description enables those skilled in the art to make or use the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the invention. Therefore, the invention is not to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A sterile medical sodium hyaluronate dressing and its processing method, comprising 0.15 parts sodium hyaluronate, 0.15 parts carbomer, 3 parts glycerin, 0.06 parts triethanolamine, 0.06 parts capryloyl hydroxamic acid, 0.75 parts 1,2-butanediol, 0.19 parts 1,2-hexanediol, and purified water, characterized in that: The preparation methods include the following: Step S1: Weigh approximately 20 portions of purified water and pour them into a mixing tank, and record the actual amount of purified water used; Step S2: Take 25 portions of purified water into a rinsing tank and use it to rinse the utensils; Step S3: Take about 25 parts of purified water into the mixing tank, then weigh 0.15 parts of carbomer U21 and slowly and evenly spread it on the surface of the purified water, let it be naturally moistened, and then stir evenly. Step S4: Take a clean container, weigh 0.06 parts of triethanolamine, pour it into the mixing tank, and rinse the container with a small amount of purified water from the rinsing tank several times. Then pour the rinsed container into the mixing tank and stir thoroughly to allow it to swell. Record the actual amount of triethanolamine used. Step S5: Adjust the speed of the mixing tank to 40 rpm, slowly pour the solution from the mixing tank into the mixing tank, then take an appropriate amount of purified water from the rinsing tank and rinse the mixing tank in small amounts several times, then pour it into the mixing tank. Step S6: Take a clean container, weigh 0.75 parts of 1,2-butanediol and 0.19 parts of 1,2-hexanediol, mix them thoroughly, then weigh 0.06 parts of capryloyl hydroxamic acid and add it to the mixture of 1,2-butanediol and 1,2-hexanediol. Heat and stir in a 50°C water bath until completely dissolved, then pour into a mixing tank. Rinse the container with the remaining purified water in the rinsing tank in small amounts several times before pouring it into the mixing tank. Record the actual amounts of 1,2-butanediol, 1,2-hexanediol, and capryloyl hydroxamic acid used. Step S7: Take a clean container, weigh 3 parts of glycerin, then weigh 0.15 parts of sodium hyaluronate and pour them into the glycerin. After dispersing them completely, pour them into a mixing jar and record the actual amount of glycerin and sodium hyaluronate used. Step S8: Calculate the total amount of all the above materials. Subtract the total amount of the above materials from the total amount of 100 parts to obtain the amount of purified water that still needs to be added to balance the mixture. Weigh the final amount of purified water and rinse the container in step S7 in small amounts several times. Slowly pour the purified water into the mixing tank. Step S9: Fill the boxes using a coating filling machine, and then seal them with a plastic sealer after packaging.

2. The medical sodium hyaluronate sterile dressing and its processing method according to claim 1, characterized in that: The natural wetting time of the carbomer U21 is 10-15 minutes, and the stirring speed is 30-35 rpm.

3. The medical sodium hyaluronate sterile dressing and its processing method according to claim 1, characterized in that: When rinsing the triethanolamine container, the amount of water used for each rinse is 1 / 3 to 1 / 2 of the container's volume, and the number of rinses is 2 to 3.

4. The medical sodium hyaluronate sterile dressing and its processing method according to claim 1, characterized in that: When the sodium hyaluronate is dispersed in glycerol, ultrasonic-assisted dispersion is used, with an ultrasonic frequency of 20-30 kHz and a dispersion time of 5-8 minutes.

5. The medical sodium hyaluronate sterile dressing and its processing method according to claim 1, characterized in that: The inner walls of the mixing tank, rinsing tank, and dispensing tank are all polished, with a surface roughness Ra≤0.8μm, and are made of 316L stainless steel.

6. The medical sodium hyaluronate sterile dressing and its processing method according to claim 1, characterized in that: The filling accuracy of the dressing filling machine is ±0.5g, the sealing temperature of the sealing machine is 120-130℃, and the sealing pressure is 0.3-0.5MPa.

7. The medical sodium hyaluronate sterile dressing and its processing method according to claim 1, characterized in that: When heating in a 50°C water bath, the stirring paddle is made of polytetrafluoroethylene, and the distance between the stirring blade and the wall of the liquid preparation tank is 2-3 cm.

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