Light-guiding gel and process for its production

Abstract

The application provides a light-guiding gel and a production process thereof. The light-guiding gel is prepared from the following raw materials in percentage by mass: 0.3-0.4% of carbomer, 0.08-0.12% of polylactic acid-glycolic acid copolymer, 1.4-1.6% of shea butter, 4.5-5.5% of glycerol, 0.1-0.2% of preservative, 0.3-0.35% of triethanolamine, 1.6-2.2% of MIST BASE (HIGH), 0.008-0.012% of essence and the balance of purified water. The light-guiding gel prepared by the application has super light transmission and heat conduction properties and good biological safety. The application not only effectively improves the treatment effect, but also greatly relieves the burning sensation of the skin, avoids thermal damage, greatly reduces the discomfort, and is beneficial to the skin barrier repair.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of medical gels, in particular to a light-guiding gel and a production process thereof. BACKGROUND

[0002] Tissue necrotic cells cannot regenerate, which will cause infection of local tissue. Such infection will cause bacteria to multiply, and the bacteria will invade the blood, causing sepsis.

[0003] With the rapid development of medical technology, photoelectric treatment methods have been widely used to improve skin problems. It is undeniable that photoelectric treatment methods based on the principle of photothermal effect cause certain thermal damage to the skin, and laser physicians will try to minimize the thermal damage to the skin caused by laser and intense pulsed light treatment methods. However, the photothermal effect generated when intense pulsed light is emitted causes a certain range of thermal damage to the surrounding tissue of the target tissue, causing the patient's skin to produce transient erythema, flushing, swelling, and even blisters, purpura, and exudation. The patient feels a burning sensation, pain, dryness, and tightness on the face, and the pain-sensitive person is difficult to endure.

[0004] Light-guiding gel, originally known as photonic cold gel, has a high-molecular network structure, so it is soft in texture and can maintain a certain shape. In terms of composition, the gel composition is safe, non-toxic, and has a pleasant odor, and even direct contact with the laser treatment head will not cause damage and corrosion to the laser treatment head. From the environmental point of view, the cold gel is mild in nature, highly safe, non-toxic, and has no side effects, and will not cause environmental pollution. In terms of properties, the cold gel has almost no irritation to human skin, and the probability of allergy is almost zero. It can also absorb a large amount of water from the surrounding environment, and can play a moisturizing and hydrating role. In addition, after contacting the cold gel, the skin feels cool and comfortable, has a calming, soothing, anti-inflammatory, and analgesic effect, can not only supplement the loss of skin moisture caused by thermal damage in time, but also can relieve the burning sensation of the skin. The cold gel is easy to use, easy to clean, has good lubricating properties, can perfectly combine with the machine performance, and has strong light transmission, heat insulation, and heat conduction properties, and does not damage the probe. It is an ideal medium for heat conduction, light transmission, and skin rejuvenation, and is widely used in intense pulsed light treatment, becoming an essential product for patients to relieve pain, burning, dryness, and discomfort. The light-guiding gel has good clinical experimental effect, and is widely used in clinical practice.

[0005] During the cold compress process of the light guide gel, the surrounding blood vessels can be contracted, the peripheral blood flow can be reduced, and the permeability of the blood vessels can be changed, so that the exudation can be reduced and the edema can be prevented, and meanwhile the metabolism of cells can be weakened and the nerve excitability can be reduced, so that the analgesic purpose can be achieved; and the light coupling effect can be enhanced, the gel can isolate air, the diffuse reflection can be reduced, more energy can be gathered under the skin, and the medical treatment effect can be increased. However, during the treatment process of the strong pulse light by using the light guide gel, the skin still produces a certain burning sensation, and even a pain sensation appears. Therefore, the prescription and the process of the light guide gel need to be further researched and optimized. SUMMARY

[0006] In view of this, the present application provides a light guide gel and a production process thereof, which effectively improve the heat conduction performance, greatly relieve the burning sensation of the skin, avoid heat damage, and greatly reduce the discomfort.

[0007] The technical scheme of the present application is as follows:

[0008] A light guide gel is prepared from the following raw materials in mass percentage: 0.3-0.4% of carbomer, 0.08-0.12% of polylactic acid-glycolic acid copolymer, 1.4-1.6% of shea butter, 4.5-5.5% of glycerol, 0.1-0.2% of preservative, 0.3-0.35% of triethanolamine, 1.6-2.2% of MIST BASE (HIGH), 0.008-0.012% of essence, and the balance of purified water.

[0009] Further, the light guide gel is prepared from the following raw materials in mass percentage: 0.36% of carbomer, 0.1% of polylactic acid-glycolic acid copolymer, 1.5% of shea butter, 5% of glycerol, 0.15% of preservative, 0.32% of triethanolamine, 2% of MIST BASE (HIGH), 0.01% of essence, and the balance of purified water.

[0010] Further, the carbomer is a homopolymer B type.

[0011] Further, the mass ratio of DLLA to GA in the polylactic acid-glycolic acid copolymer is 65-70:30-35.

[0012] Further, the manufacturer of the MIST BASE (HIGH) is H&AP PHARMACHEM in South Korea.

[0013] Further, the essence is lemon essence.

[0014] The production process of the light guide gel comprises the following steps:

[0015] (1) according to the prescription amount respectively take each raw material, add purified water in the prescription amount 65-75wt% ratio to the container, then slowly pour the carbomer into the container, soak for 12-24h;

[0016] (2) add the preservative, glycerol and shea butter to the container, stir and heat, set the stirring speed: 450-550rpm; after heating to 75-85℃, add polylactic acid-glycolic acid copolymer, homogenize, homogenization speed: 4500-5500rpm, homogenization time: 5-8min; after homogenization stops, continue to stir, keep the material temperature in the container at 75-85℃, heat for 30-40min, then cool to below 45℃ with cooling water;

[0017] (3) add triethanolamine, MIST BASE(HIGH) and essence to the container in sequence, add the remaining purified water in the prescription amount to the container, stir to obtain the light-conducting gel.

[0018] Further, in step (2), the homogenization uses a digital high-speed dispersion homogenizer.

[0019] Further, in step (2), the stirring uses an overhead stirrer.

[0020] Compared with the prior art, the present application has the following beneficial effects:

[0021] (1) The present application uses homopolymer carbomer, polylactic acid-glycolic acid copolymer, shea butter, glycerol, triethanolamine, MIST BASE(HIGH) and the like as raw materials, and scientifically prepares the light-conducting gel, which has good light transmission and heat conduction properties, and good biological safety.

[0022] (2) The present application adds polylactic acid-glycolic acid copolymer and shea butter in the prescription, which has good biocompatibility and biological activity, can significantly improve the gel heat conduction performance, not only effectively improves the treatment effect, but also greatly relieves the burning sensation of the skin, avoids thermal damage, greatly reduces the discomfort, and is beneficial to skin barrier repair.

[0023] (3) The present application uses polylactic acid-glycolic acid copolymer (DLLA:GA=65:35), which further helps to improve the heat conduction performance and further improves the use comfort. DETAILED DESCRIPTION

[0024] In order to better understand the technical content of the present application, the following specific examples are provided to further illustrate the present application.

[0025] The experimental methods used in the examples of the present application are conventional methods unless otherwise specified.

[0026] The materials, reagents, etc. used in the embodiments of the present application, if not specifically stated, can be obtained from commercial channels. The manufacturer of MIST BASE (HIGH) used in the present application is H&AP PHARMACHEM of South Korea, and the Chinese name is silicone emulsion.

[0027] The model specifications of some of the equipment used in the present application are as follows:

[0028]

[0029]

[0030] Example 1

[0031] Prescription table

[0032]

[0033] Production process

[0034] (1) Put 70% of the purified water of the prescription batch into the container, then weigh the carbomer and slowly pour it into the container, soak for more than 12 hours;

[0035] (2) Put the weighed hydroxyphenyl ethyl ester, glycerol and shea butter into the container, place it on the overhead stirrer for stirring and heat it with a constant temperature closed electric furnace. The overhead stirrer is set to a stirring speed of 500 rpm. After heating to 80℃±5℃, add polylactic acid-hydroxyacetic acid copolymer, and use a digital high-speed dispersion homogenizer to homogenize at a speed of 5000 rpm for 5 minutes. After homogenization stops, continue to stir until completely dissolved, and keep the material temperature in the container at 80℃±5℃, heat for 30 minutes, then cool it with cold water to below 45℃;

[0036] (3) Put the weighed triethanolamine, MIST BASE (HIGH) and lemon essence into the container in turn, add the remaining purified water of the prescription amount into the container, stir until completely dissolved, and the material appears as a milky white transparent gel. The light guide gel is prepared.

[0037] Example 2

[0038] Prescription table

[0039]

[0040] Production process

[0041] (1) Put 70% of the purified water of the prescription batch into the container, then weigh the carbomer and slowly pour it into the container, soak for more than 12 hours;

[0042] (2) Weighed hydroxyphenyl ethyl ester, glycerol, and add them to the container, place it on the overhead stirrer for stirring and heat it with the constant temperature closed electric furnace, set the stirring speed of the overhead stirrer to 500 rpm; after heating to 80±5℃, add polylactic acid-glycolic acid copolymer, homogenize it with the digital high-speed dispersion homogenizer, homogenization speed: 5000 rpm, homogenization time: 5 minutes; after stopping homogenization, continue stirring until complete dissolution, and keep the temperature of the material in the container at 80±5℃, heat for 30 minutes, then cool it down to below 45℃ with cooling water;

[0043] (3) Weighed triethanolamine, MIST BASE (HIGH), and lemon essence, add them to the container in sequence, add all the purified water remaining in the prescription to the container, stir until complete dissolution, and the material appears as a milky white transparent gel, thus preparing the light-conducting gel.

[0044] Example 3

[0045] Prescription table

[0046]

[0047]

[0048] Production process

[0049] (1) Weighed purified water in the prescription batch in the proportion of 70%, add it to the container, then weigh the carbomer and slowly pour it into the container, soak for more than 12 hours;

[0050] (2) Weighed hydroxyphenyl ethyl ester, glycerol, and add them to the container, place it on the overhead stirrer for stirring and heat it with the constant temperature closed electric furnace, set the stirring speed of the overhead stirrer to 500 rpm; after heating to 80±5℃, add polylactic acid-glycolic acid copolymer, homogenize it with the digital high-speed dispersion homogenizer, homogenization speed: 5000 rpm, homogenization time: 5 minutes; after stopping homogenization, continue stirring until complete dissolution, and keep the temperature of the material in the container at 80±5℃, heat for 30 minutes, then cool it down to below 45℃ with cooling water;

[0051] (3) Weighed triethanolamine, MIST BASE (HIGH), and lemon essence, add them to the container in sequence, add all the purified water remaining in the prescription to the container, stir until complete dissolution, and the material appears as a milky white transparent gel, thus preparing the light-conducting gel.

[0052] Example 4

[0053] The main difference from Example 1 is that the polylactic acid-glycolic acid copolymer (DLLA: GA = 50:50).

[0054] Prescription table

[0055]

[0056]

[0057] Production process is prepared according to example 1.

[0058] Comparative example 1

[0059] In this comparative example, polylactic acid-glycolic acid copolymer and shea butter are not added in the prescription, and are replaced by polylactic acid and coconut oil. The specific prescription is as follows.

[0060] Prescription table

[0061] No. Ingredient Name Prescribed Proportion (% by mass) 1 Carbomer (homopolymer type B) 0.36 2 Polylactic acid 0.1 3 Coconut oil 1.5 4 Glycerin 5 5 Hydroxyphenyl ethyl ester 0.15 6 Triethanolamine 0.32 7 MIST BASE (HIGH) 2 8 Lemon flavor 0.01 9 Purified water 90.56 Total 100％

[0062] Production process

[0063] (1) Put 70% of the purified water of the prescription batch into the container, then weigh the carbomer and slowly pour it into the container, soak for more than 12 hours;

[0064] (2) Put the weighed hydroxyphenyl ethyl ester, glycerol and coconut oil into the container, place it on the overhead stirrer for stirring and heat it with a constant temperature sealed electric furnace. The stirring speed of the overhead stirrer is set to 500 rpm. After heating to 80℃±5℃, use a digital high-speed dispersion homogenizer for homogenization, with a homogenization speed of 5000 rpm and a homogenization time of 5 minutes. After homogenization, continue to stir until completely dissolved, and keep the temperature of the material in the container at 80℃±5℃, heat for 30 minutes, then cool it down to below 45℃ with cooling water;

[0065] (3) Put the weighed triethanolamine, MIST BASE(HIGH) and lemon essence into the container in turn, and add all the remaining purified water of the prescription into the container, stir until completely dissolved, and prepare the light guide gel.

[0066] Comparative example

[0067] Prescription table

[0068] No. Ingredient Name Prescribed Proportion (% by mass) 1 Carbomer (homopolymer type B) 0.46 2 Glycerin 6.5 3 Hydroxyphenyl ethyl ester 0.15 4 Triethanolamine 0.32 5 MIST BASE (HIGH) 2 6 Lemon flavor 0.01 7 Purified water 90.56 Total 100％

[0069] Production process

[0070] (1) Put 70% of the purified water of the prescription batch into the container, then weigh the carbomer and slowly pour it into the container, soak for more than 12 hours;

[0071] (2) Weighed hydroxyphenyl ethyl ester, glycerol, and placed in a container, placed on the overhead stirrer for stirring and heating with constant temperature closed electric furnace, the overhead stirrer was set to stirring speed: 500 rpm; after heating to 80℃±5℃, add polylactic acid-glycolic acid copolymer, homogenize with digital high-speed dispersion homogenizer, homogenization speed: 5000 rpm, homogenization time: 5 minutes; after homogenization stop, continue to open the stirring to completely dissolve, and keep the container temperature at 80℃±5℃, heat preservation for 30 minutes, then cool to below 45℃ with cooling water;

[0072] (3) Weighed triethanolamine, MIST BASE(HIGH) and lemon essence, added to the container in turn, all the remaining purified water in the prescription was added to the container, stirred to completely dissolve, the material body presented milky white transparent gel, and the light guide gel was prepared.

[0073] Test example

[0074] 1. Skin sensitization test

[0075] The light guide gel prepared in examples 1-4 and comparative example 1, and control example was prepared into a test solution, and the skin sensitization test was carried out according to the method of GB / T16886.10-2017, the results showed that the light guide gels prepared in examples 1-4 and comparative example 1, and control example had no sensitization.

[0076] 2. Light guide gel performance test

[0077] The light guide gels prepared in examples 1-4 and comparative example 1 were tested for thermal conductivity, light transmittance, etc., and compared with the light guide gel of the control example, and the thermal conductivity improvement percentage was calculated.

[0078] (1) Thermal conductivity detection: TC3000 type thermal conductivity measuring instrument was used to measure the thermal conductivity of the light guide gel.

[0079] (2) Light transmittance detection: the light guide gel was cut into small pieces (20mm×10mm×5mm), placed in a cuvette (40mm×10mm×5mm), and then ultrapure water was injected into the cuvette. The light transmittance of the light guide gel was measured at 500nm with a 721B visible spectrophotometer.

[0080] (3) Thermal conductivity improvement percentage=(thermal conductivity of example / thermal conductivity of comparative example-thermal conductivity of control example) / thermal conductivity of control example*100%.

[0081] The results are shown in the following table 1:

[0082]

[0083] The results of Table 1 show that the light transmittance and the thermal conductivity of the light guide gel prepared in Examples 1-4 and Comparative Example 1 are improved compared with the control, and the thermal conductivity is significantly improved, in which the thermal conductivity of Examples 1-4 is improved more obviously.

[0084] In which, the thermal conductivity effect of Example 1 is better than that of poly-lactic acid-glycolic acid copolymer (DLLA: GA = 50:50) compared with Example 4.

[0085] In Comparative Example 1, poly-lactic acid-glycolic acid copolymer and shea butter are not added, but poly-lactic acid and coconut oil are added, and compared with Example 1, the light transmittance and the thermal conductivity of the gel are decreased.

[0086] The above only describes the preferred embodiments of the present application and is not intended to limit the present application. Any modification, equivalent replacement, improvement, etc. made within the principles and principles of the present application shall be included in the protection scope of the present application.

Claims

1. A light-guiding gel, characterized in that, It is prepared from the following raw materials in the indicated mass percentages: 0.3%~0.4% carbomer, 0.08%~0.12% polylactic acid-glycolic acid copolymer, 1.4%~1.6% shea butter, 4.5%~5.5% glycerin, 0.1%~0.2% preservative, 0.3%~0.35% triethanolamine, 1.6%~2.2% MIST BASE (HIGH), 0.008%~0.012% lemon flavor, and the balance being purified water; wherein the carbomer is a homopolymer type B; and the mass ratio of DLLA to GA in the polylactic acid-glycolic acid copolymer is 65~70:30~35.

2. The light-guiding gel according to claim 1, characterized in that, It is made from the following raw materials in weight percentages: 0.36% carbomer, 0.1% polylactic acid-glycolic acid copolymer, 1.5% shea butter, 5% glycerin, 0.15% preservative, 0.32% triethanolamine, 2% MIST BASE (HIGH), 0.01% fragrance and the balance purified water.

3. The light-guiding gel according to claim 1, characterized in that, The manufacturer of the MIST BASE (HIGH) is H&A PHARMACHEM in South Korea.

4. The light-guiding gel according to claim 1, characterized in that, The preservative is ethylparaben.

5. The manufacturing process of the light-guiding gel according to any one of claims 1-4, characterized in that, Includes the following steps: (1) Weigh each raw material according to the prescription dosage, add 65-75 wt% of the prescription amount of purified water into the container, and then slowly pour carbomer into the container and soak for 12-24 hours; (2) Add the preservative, glycerin and shea butter to a container, stir and heat, and set the stirring speed to 450~550 rpm; After heating to 75~85℃, add polylactic acid-glycolic acid copolymer and homogenize. Homogenize at a speed of 4500~5500 rpm for 5~8 minutes. After homogenization stops, continue stirring and keep the temperature of the material in the container at 75~85℃ for 30~40 minutes. Then cool down to below 45℃ with cooling water. (3) Add triethanolamine, MIST BASE (HIGH) and fragrance to the container in sequence, add all the remaining purified water in the prescription to the container, stir, and obtain the light guide gel.

6. The production process of the light guide gel according to claim 5, characterized in that, In step (2), the homogenization is performed using a digital display high-speed dispersion homogenizer.

7. The manufacturing process of the light-guiding gel according to claim 5 or 6, characterized in that, In step (2), the stirring is performed using a top-mounted stirrer.

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