Preparation process of cleaning and disinfecting solution and neutralizing tablet for orthokeratology lens

Abstract

The invention discloses a preparation process of a cleaning and disinfecting solution and a neutralizing tablet for an orthokeratology lens, which comprises the following steps: firstly, selecting high-purity hydrogen peroxide, and adding a stabilizer, a pH regulator and the like to prepare 3% hydrogen peroxide; secondly, selecting Korean polyethylene glycol 6000, Germany BASF poloxamer 407, analytic-grade EDTA (Ethylene Diamine Tetraacetic Acid)-disodium, catalase and the like to prepare a neutralizing tablet; 3% hydrogen peroxide and the neutralization tablet are subjected to a neutralization reaction, and the cleaning and disinfection capacity and hydrogen peroxide and enzyme preparation residues are measured. The cleaning disinfectant for the orthokeratology lens, disclosed by the invention, is stable in property and good in sterilizing effect after being compounded; a high-activity enzyme preparation and a surfactant are added into the neutralization tablet and are efficient in neutralization, high in cleaning and disinfecting capacity and free of drug resistance; nursing is simple, no residues exist, eye irritation is avoided, and the liquid can directly enter eyes after being cleaned and disinfected; the lens does not need to be rubbed in the nursing process, the lens damage risk is greatly reduced, and it is guaranteed that the lens is convenient to use.

Description

Technical Field

[0001] The present invention relates to the field of preparation technology of orthokeratology lens cleaning and disinfection solution, and in particular to a preparation technology of orthokeratology lens cleaning and disinfection solution and neutralization sheet. Background Art

[0002] Hydrogen peroxide is a colorless, transparent liquid, an aqueous solution obtained by mixing hydrogen peroxide with water. Its disinfection mainly relies on the hydrogen peroxide in it. It is a peroxide that can kill bacteria and disinfect, especially for microorganisms including bacterial propagules, spores, fungi and viruses. It is inherently unstable and easily hydrolyzed. Its disinfection principle is to decompose hydrogen peroxide to generate water molecules and oxygen atoms, and use oxygen atoms to enter the interior of microorganisms, causing changes in related enzymes of bacteria, or destroying the nucleic acid structure of viruses, thereby killing bacteria and playing a disinfection role.

[0003] However, hydrogen peroxide has a strong oxidizing property. If 3% hydrogen peroxide is used directly to clean and disinfect orthokeratology lenses, the residual hydrogen peroxide on the lens surface after cleaning is very irritating and cannot be worn directly. Even if it is rinsed with care solution, some residue will remain. In addition, 3% hydrogen peroxide is inconvenient to carry. If it is spilled during use, it will cause certain damage to the human body surface. This greatly limits its application. A preparation process for a cleaning and disinfection solution and a neutralizing sheet for orthokeratology lenses. Summary of the invention

[0004] Based on the technical problems existing in the background technology, the present invention proposes a preparation process for a cleaning and disinfecting solution and a neutralizing sheet for orthokeratology lenses.

[0005] The present invention provides a preparation process for a cleaning and disinfecting solution and a neutralizing sheet for orthokeratology lenses, comprising the following steps: S1: Mix 30% hydrogen peroxide, EDI test water, EDTA-disodium, sodium dihydrogen phosphate, disodium hydrogen phosphate, sodium chloride, Pluronic 17R4 and DEOUESTO 2060S evenly, and test the hydrogen peroxide content and pH; S2: Select hydroxypropyl methylcellulose and soak it in 50 times EDI water for 8 hours in advance to make it into a uniform transparent viscous liquid for use. Use a rotational viscometer to test the viscosity, which is 6000-1000mpa.s (rotor No. 3, 12RPM). S3: Select polyethylene glycol 6000, sodium chloride, filler, boric acid and borax and grind them through 80 mesh sieve by water circulating cooling grinder respectively for later use; S4: Select EDTA-disodium, hydroxypropyl methylcellulose, polyvinyl pyrrolidone, catalase, polymer enzyme preparation and vitamin B12 and pass them through 80 mesh sieves to ensure that the particle size of the material is uniform and set aside; S5: Select poloxamer and use a mortar dried at 105°C, grind it slowly (30 times / min), and then pass it through an 80-mesh sieve for later use; S6: Take S3, S4 and S5 and mix them in a three-dimensional mixer for 15 to 20 minutes (speed 45 rpm) to make 999 g of uniform powder; set aside; S7: Take 900g of the evenly mixed S6, put it into a trough mixer, spray 50ml of analytical grade anhydrous ethanol, start stirring, mix for 5 minutes (speed 30 rpm), after it becomes wet powder, add the pre-soaked adhesive S2, continue stirring for 10 minutes, and turn off stirring. Manually test the material, knead it into a ball, rub it and it will fall apart easily, set aside; S8: Take S7 and make it into uniform wet granules through a 20-mesh sieve for later use; S9: Take S8 and put it into a hot air circulation drying oven for low temperature drying for 6 to 8 hours. Use a fast moisture meter to test the moisture content to be between 0.7 and 1.0%, and set aside. S10: Take S9 and sieve it through an 18-mesh sieve to make granules for later use; S11: Take S10 and the remaining 99g of S6 and add them into a three-dimensional mixer and mix for 15-20 minutes (speed 45 rpm) to make 1000g, set aside; S12: Take S11 and add it to the rotary tablet press for tableting (tablet weight 0.1g / tablet). Turn on the dehumidifier during the whole process to ensure that the ambient temperature and humidity meet the set process requirements. Check the difference in the tablets every 15 minutes, and control the error within 0.1g + 10%, the tablet surface should be smooth, without stains, spots, or cracks. Take 10 tablets, blow off the surface powder, add them to the friability tester, rotate them 100 times, and the weight loss should not exceed 1.0%; take 6 tablets and use the disintegration time tester to measure, the disintegration time should be less than 15 minutes; take 1 tablet and dissolve it in 50ml, 25℃ test water, and use a calibrated acidometer to measure the pH.

[0006] Preferably, in S1, the 30% hydrogen peroxide is of analytical grade, and the pH value of the 3% hydrogen peroxide is 4.0-7.0.

[0007] Preferably, in S2 to S12, the neutralizing tablets are selected from Lotte polyethylene glycol 6000 from South Korea and poloxamer 407 from BASF of Germany, high-purity analytical grade EDTA-disodium, polyvinyl pyrrolidone, sodium chloride, boric acid and borax from national medicines, pharmaceutical grade vitamin B12, hydroxypropyl methylcellulose and polymer enzyme preparations, food grade lactose and catalase, and the pH of the neutralizing tablets is 6.2 to 7.2.

[0008] Preferably, in S4, the neutralizing sheet polymer enzyme preparation is selected from polymer enzyme preparation A enzyme, trypsin or elastase, and vitamin B12 is a natural product, and the main component is cobalamin.

[0009] Preferably, in S5, the neutralizing poloxamer is selected from Poloxamer 407 of BASF, Germany.

[0010] Preferably, in the preparation of the neutralized tablets S3, the low-temperature pulverizing temperature is controlled within the range of 25°C to 30°C, in S9, the low-temperature drying temperature is controlled within the range of 35 to 40°C, in S12, the ambient temperature range is 16 to 20°C, and the humidity range is 45% to 60%.

[0011] Preferably, the neutralization tablet filler is selected from one of calcium sulfate, calcium hydrogen phosphate, nano-β-cyclodextrin and soluble starch.

[0012] Preferably, the neutralization tablet high molecular enzyme preparation content is 300U + 200 U / tablet, catalase content is 1.50 + 0.6mUA.

[0013] The 3% hydrogen peroxide and neutralization tablets made using the above process technology have been neutralized and tested. After 60 minutes of neutralization, the residual hydrogen peroxide was detected to be 0, with strong protein removal ability and no irritation when worn directly. The entire reaction process has stable foaming, uniform gas production, and no liquid overflow. The process is mature, safe, and stable, meeting the requirements for cleaning and disinfection of orthokeratology lenses. Implementation

[0014] The present invention will be further explained below in conjunction with specific embodiments. Example

[0015] This embodiment proposes a preparation process for a cleaning and disinfecting solution and a neutralizing sheet for orthokeratology lenses, comprising the following steps: S1: 30% hydrogen peroxide, EDI test water, EDTA-disodium, sodium dihydrogen phosphate, disodium hydrogen phosphate, sodium chloride, Pluronic 17R4 and DEOUESTO 2060S were mixed evenly, and the hydrogen peroxide content was tested to be 3.0% and the pH was 4.5; S2: Take 1g of hydroxypropyl methylcellulose and add it to 99g of EDI water and soak it for 8 hours in advance to make it into a uniform transparent viscous liquid for later use. Use a rotational viscometer to test the viscosity, which is 5875mpa.s (rotor No. 2, 30RPM), and set it aside; S3: Select polyethylene glycol 6000, sodium chloride, filler, boric acid and borax, respectively grind them through 80-mesh sieve using a water-circulating cooling grinder, and set aside; S4: Select 2% EDTA-disodium, hydroxypropyl methylcellulose, polyvinyl pyrrolidone, 5% catalase, high molecular enzyme preparation and vitamin B12 and pass them through 80 mesh sieve respectively to ensure that the particle size of the material is uniform and set aside; S5: Select poloxamer and use a mortar dried at 105°C, grind it slowly (30 times / min), and then pass it through an 80-mesh sieve for later use; S6: Take S3, S4 and S5 and mix them in a three-dimensional mixer for 17 minutes (speed 45 rpm) to make 999 g of uniform powder; set aside; S7: Take 999g of the evenly mixed S6, put it into a trough mixer, spray 50ml of analytical grade anhydrous ethanol, start stirring, mix for 5 minutes (speed 30 rpm), after it becomes wet powder, add the pre-soaked adhesive S2, continue stirring for 10 minutes, and turn off stirring. Manually test the material, knead it into a ball by hand, and it is easy to disperse when rubbed, and set aside; S8: Take S7 and make it into uniform wet granules through a 20-mesh sieve for later use; S9: Take S8 and put it into a hot air circulation drying oven for low temperature drying for 7.5 hours. Use a fast moisture meter to check the moisture content to be between 0.8%, and set aside. S10: Take S9 and sieve it through an 18-mesh sieve to make granules for later use; S11: Take S10 and add it into a three-dimensional mixer and mix for 16 minutes (speed 45 rpm) to make 1000 g, set aside; S12: Take S11 and add it to the rotary tablet press for tableting (tablet weight 0.1g / tablet). Turn on the dehumidifier during the whole process to ensure that the ambient temperature and humidity meet the set process requirements. Check the difference in the tablets every 15 minutes, and the error is controlled at 0.1g+10%. The tablet surface should be smooth, without stains, spots, or cracks. Take 10 tablets, blow off the surface powder, add them to the friability tester, rotate 100 times, and the weight loss is 0.8%; take 6 tablets and use the disintegration time limit tester to measure, and the disintegration time is 10 minutes; take 1 tablet and dissolve it in 50ml, 25℃ test water, and use a calibrated acidometer to measure the pH to 6.4. Example

[0016] This embodiment proposes a preparation process for a cleaning and disinfecting solution and a neutralizing sheet for orthokeratology lenses, comprising the following steps: S1: 30% hydrogen peroxide, EDI test water, EDTA-disodium, sodium dihydrogen phosphate, disodium hydrogen phosphate, sodium chloride, Pluronic 17R4 and DEOUESTO 2060S were mixed evenly, and the hydrogen peroxide content was tested to be 3.0% and the pH was 7.0; S2: Take 1g of hydroxypropyl methylcellulose and add it to 33g of EDI water and soak it for 8 hours in advance to make it into a uniform transparent viscous liquid for later use. Use a rotational viscometer to test the viscosity, and the viscosity is 12500mpa.s (rotor No. 4, 30RPM), and set aside; S3: Select polyethylene glycol 6000, sodium chloride, filler, boric acid and borax, respectively grind them through 80-mesh sieve using a water-circulating cooling grinder, and set aside; S4: Select EDTA-disodium 8%, hydroxypropyl methylcellulose, polyvinyl pyrrolidone, catalase 10%, polymer enzyme preparation and vitamin B12 and pass them through 80 mesh sieve respectively to ensure that the particle size of the material is uniform and set aside; S5: Select poloxamer and use a mortar dried at 105°C, grind it slowly (30 times / min), and then pass it through an 80-mesh sieve for later use; S6: Take S3, S4 and S5 and mix them in a three-dimensional mixer for 18 minutes (speed 45 rpm) to make 999 g of uniform powder; set aside; S7: Take 800g of the evenly mixed S6, put it into a trough mixer, spray 50ml of analytical grade anhydrous ethanol, start stirring, mix for 5 minutes (speed 30 rpm), add the pre-soaked adhesive S2 after it becomes wet powder, continue stirring for 12 minutes, and turn off stirring. Manually test the material, knead it into a ball, rub it and it will fall apart easily, and set it aside; S8: Take S7 and make it into uniform wet granules through a 20-mesh sieve for later use; S9: Take S8 and put it into a hot air circulation drying oven for low temperature drying for 6 hours. Use a fast moisture meter to check the moisture content to be between 0.7%, and set aside; S10: Take S9 and sieve it through an 18-mesh sieve to make granules for later use; S11: Take the remaining 199 g of S10 and S6 and add them into a three-dimensional mixer and mix for 17 minutes (speed 45 rpm) to make 1000 g for later use; S12: Take S11 and add it to the rotary tablet press for tableting (tablet weight 0.1g / tablet). Turn on the dehumidifier during the whole process to ensure that the ambient temperature and humidity meet the set process requirements. Check the difference in the tablets every 15 minutes, and the error is controlled at 0.1g+10%. The tablet surface should be smooth, without stains, spots, or cracks. Take 10 tablets, blow off the surface powder, add them to the friability tester, rotate 100 times, and the weight loss is 0.7%; take 6 tablets and use the disintegration time limit tester to measure, and the disintegration time is 25 minutes; take 1 tablet and dissolve it in 50ml, 25℃ test water, and use a calibrated acidometer to measure the pH to 6.9. Example

[0017] This embodiment proposes a preparation process for a cleaning and disinfecting solution and a neutralizing sheet for orthokeratology lenses, comprising the following steps: S1: 30% hydrogen peroxide, EDI test water, EDTA-disodium, sodium dihydrogen phosphate, disodium hydrogen phosphate, sodium chloride, Pluronic 17R4 and DEOUESTO 2060S were mixed evenly, and the hydrogen peroxide content was 3.0% and the pH was 6.6; S2: Select 1g of hydroxypropyl methylcellulose and add it to 49g of EDI water and soak it for 8 hours in advance to make it into a uniform transparent viscous liquid for later use. Use a rotational viscometer to test the viscosity, which is 7565mpa.s (rotor No. 3, 15RPM), and set aside; S3: Select polyethylene glycol 6000, sodium chloride, filler, boric acid and borax, respectively, and grind them through an 80-mesh sieve using a water-circulating cooling grinder for later use; S4: Select 5% EDTA-disodium, hydroxypropyl methylcellulose, polyvinyl pyrrolidone, 8% catalase, high molecular enzyme preparation and vitamin B12 and pass them through 80 mesh sieve respectively to ensure that the particle size of the material is uniform and set aside; S5: Select poloxamer and use a mortar dried at 105°C, grind it slowly (30 times / min), and then pass it through an 80-mesh sieve for later use; S6: Take S3, S4 and S5 and mix them in a three-dimensional mixer for 16 minutes (speed 45 rpm) to make 999 g of uniform powder; set aside; S7: Take 900g of the evenly mixed S6, put it into a trough mixer, spray 50ml of analytical grade anhydrous ethanol, start stirring, mix for 7 minutes (speed 30 rpm), after it becomes wet powder, add the pre-soaked adhesive S2, continue stirring for 13 minutes, and turn off stirring. Manually test the material, knead it into a ball, rub it and it will fall apart easily, set aside; S8: Take S7 and make it into uniform wet granules through a 20-mesh sieve for later use; S9: Take S8 and put it into a hot air circulation drying oven for low temperature drying for 8 hours. Use a fast moisture meter to check the moisture content to be between 0.6%, and set aside; S10: Take S9 and sieve it through an 18-mesh sieve to make granules for later use; S11: Take the remaining 99g of S10 and S6 and add them into a three-dimensional mixer and mix for 15 minutes (speed 45 rpm) to make 1000g, set aside; S12: Take S11 and add it to the rotary tablet press for tableting (tablet weight 0.1g / tablet). Turn on the dehumidifier during the whole process to ensure that the ambient temperature and humidity meet the set process requirements. Check the difference in the tablets every 15 minutes, and control the error within 0.1g + 10%, the tablet surface should be smooth, without stains, spots, or cracks. Take 10 tablets, blow off the surface powder and add them to the friability tester, rotate 100 times, and the weight loss is 0.6%; take 6 tablets and use the disintegration time tester to measure, the disintegration time is 18 minutes; take 1 tablet and dissolve it in 50ml, 25℃ test water, and use a calibrated acidometer to measure the pH to 6.7.

[0018] The present invention proposes a preparation process for a corneal reshaping lens cleaning and disinfection solution and a neutralizing sheet, which has the advantages of safety, high efficiency, ease of use, simple process, and suitability for industrial production, and implementation three is the best embodiment.

[0019] The above description is only a preferred specific implementation manner of the present invention, but the protection scope of the present invention is not limited thereto. Any technician familiar with the technical field can make equivalent replacements or changes according to the technical scheme and inventive concept of the present invention within the technical scope disclosed by the present invention, which should be covered by the protection scope of the present invention.

Claims

1. A process for preparing a cleaning and disinfecting solution and a neutralizing tablet for orthokeratology lenses, characterized in that: The following steps are involved: S1: Mix 30% hydrogen peroxide, EDI test water, EDTA-disodium, sodium dihydrogen phosphate, disodium hydrogen phosphate, sodium chloride, Pluronic 17R4 and DEOUESTO 2060S evenly, and test the hydrogen peroxide content and pH; S2: Select hydroxypropyl methylcellulose and soak it in 50 times EDI water for 8 hours in advance to make it into a uniform transparent viscous liquid for use. Use a rotational viscometer to test the viscosity, which is 6000-1000mpa.s (rotor No. 3, 12RPM). S3: Select polyethylene glycol 6000, sodium chloride, filler, boric acid and borax and grind them through 80 mesh sieve by water circulating cooling grinder respectively for later use; S4: Select EDTA-disodium, hydroxypropyl methylcellulose, polyvinyl pyrrolidone, catalase, polymer enzyme preparations and vitamin B 12 Pass them through 80-mesh sieves respectively to ensure uniform particle size and set aside; S5: Select poloxamer and use a mortar dried at 105°C, grind it slowly (30 times / min), and then pass it through an 80-mesh sieve for later use; S6: Take S3, S4 and S5 and mix them in a three-dimensional mixer for 15 to 20 minutes (speed 45 rpm) to make 999 g of uniform powder; set aside; S7: Take 900g of the evenly mixed S6, put it into a trough mixer, spray 50ml of analytical grade anhydrous ethanol, start stirring, mix for 5 minutes (speed 30 rpm), after it becomes wet powder, add the pre-soaked adhesive S2, continue stirring for 10 minutes, and turn off stirring. Manually test the material, knead it into a ball, rub it and it will fall apart easily, set aside; S8: Take S7 and make uniform wet granules through a 20-mesh sieve for later use; S9: Take S8 and put it into a hot air circulation drying oven for low temperature drying for 6 to 8 hours. Use a fast moisture meter to test the moisture content to be between 0.7 and 1.0%, and set aside. S10: Take S9 and sieve it through an 18-mesh sieve to make granules for later use; S11: Take S10 and the remaining 99g of S6 and add them into a three-dimensional mixer and mix for 15-20 minutes (speed 45 rpm) to make 1000g, set aside; S12: Take S11 and add it to the rotary tablet press for tableting (tablet weight 0.1g / tablet). Turn on the dehumidifier during the whole process to ensure that the ambient temperature and humidity meet the set process requirements. Check the difference in the tablets every 15 minutes, and the error should be controlled at 0.1g+10%. The tablet surface should be smooth, without stains, spots, or cracks. Take 10 tablets, blow off the surface powder, add them to the friability tester, rotate 100 times, and the weight loss should not exceed 1.0%; take 6 tablets and use the disintegration time limit tester to measure, and the disintegration time should be less than 30 minutes; take 1 tablet and dissolve it in 50ml, 25℃ test water, and use a calibrated acidometer to measure the pH.

2. The orthokeratology lens cleaning and disinfecting solution and neutralizing tablet according to claim 1, characterized in that: The hydrogen peroxide is of analytical grade, the neutralizing tablets are selected from South Korea's Lotte polyethylene glycol 6000 and Germany's BASF poloxamer 407, national medicine high-purity analytical grade EDTA-disodium, polyvinyl pyrrolidone, sodium chloride, boric acid and borax, medical grade vitamin B12, hydroxypropyl methylcellulose and polymer enzyme preparations, food grade lactose and catalase.

3. The orthokeratology lens cleaning and disinfecting solution and neutralizing tablet according to claim 1, characterized in that: The pH value of the 3% hydrogen peroxide solution is 4.0-7.0, and the pH value of the neutralization tablet is 6.2-7.

2.

4. The orthokeratology lens cleaning and disinfecting solution and neutralizing tablet according to claim 1, characterized in that: The neutralizing sheet polymer enzyme preparation is selected from one of polymer enzyme preparation A enzyme, trypsin or elastase.

5. The orthokeratology lens cleaning and disinfecting solution and neutralizing tablet according to claim 1, characterized in that: The neutralizing tablet vitamin B 12 It is a natural product, and its main ingredients are cobalamin and poloxamer 407 from BASF of Germany.

6. The orthokeratology lens cleaning and disinfecting solution and neutralizing tablet according to claim 1, characterized in that: The structural formula of the neutralizing tablet polymer enzyme activator is as follows: Among them, a:b:c:d=(2-5):(1-2):(5-10):(2-4); X is a halogen; Y is an alkyl chain segment; R is an alkyl chain segment.

7. The orthokeratology lens cleaning and disinfecting solution and neutralizing tablet according to claim 1, characterized in that: In the preparation of the neutralized tablets, the low-temperature crushing temperature in S3 is controlled within the range of 25°C to 30°C, the low-temperature drying temperature in S9 is controlled within the range of 35°C to 40°C, the ambient temperature in S12 is within the range of 16°C to 20°C, and the humidity is within the range of 45% to 60%.

8. The orthokeratology lens cleaning and disinfecting solution and neutralizing tablet according to claim 1, characterized in that: The neutralization tablet filler is selected from one of calcium sulfate, calcium hydrogen phosphate, nano-β-cyclodextrin and soluble starch.

9. The orthokeratology lens cleaning and disinfecting solution and neutralizing tablet according to claim 1, characterized in that: The neutralization tablet high molecular enzyme preparation content is 300U + 200 U / tablet, catalase content is 1.50 + 0.6mUA.

10. The orthokeratology lens cleaning and disinfecting solution and neutralizing tablet according to claim 1, characterized in that: The total mass of the neutralization tablet is 100%, and the mass percentage of each component is: High molecular weight enzyme preparation 0.1~3% Polyethylene glycol 6000 1~30% Poloxamer 0.1~2% EDTA-disodium 0.1~3% Polyvinylpyrrolidone 1~10% Sodium chloride 1~30% Boric acid 0.1~3% Borax 0.1~2% Vitamin B 12 1~5% Hydroxypropyl methylcellulose 0.1~3% Lactose 0.1~3% Catalase 1-15% The balance is filler.

11. The orthokeratology lens cleaning and disinfecting solution and neutralizing tablet according to claim 1, characterized in that: The total mass of the neutralization tablet is 100%, and the mass percentage of each component is: High molecular weight enzyme preparation 0.1~1% Polyethylene glycol 6000 1~15% Poloxamer 0.1~1% EDTA-disodium 0.1~1% Polyvinylpyrrolidone 1~5% Sodium chloride 1~15% Boric acid 0.1~1% Borax 0.1~1% Vitamin B 12 1~2.5% Hydroxypropyl methylcellulose 0.1~1% Lactose 0.1~1% Catalase 1-7% The balance is filler.