Adapalene gel and production process thereof

Abstract

The invention discloses adapalene gel and a production process. The adapalene gel is prepared from carbomer 980, poloxamer 188, propylene glycol, edetate disodium, phenoxyethanol, methylparaben, sodium hydroxide, purified water, azone and plant essential oil. The method comprises the following steps: 1, preparing raw materials; step 2, preparing an adapalene dispersion; 3, preparing an active phase; step 4, auxiliary material treatment; step 5, preparing a gel matrix; step 6, gelatinizing and adjusting; step 7, ultrasonic dispersion treatment; and step 8, quality detection and packaging. According to the invention, the plant essential oil is added in the preparation process of the gel matrix, so that pungent smells of various auxiliary materials in the product are covered, and smell stimulation to a user is avoided; the azone is added in the preparation process, so that the skin permeation effect of the product is improved, and the use effect of the product is improved; ultrasonic dispersion equipment is used for dispersing the product, so that the texture of the gel is finer and more uniform, and the use experience of a user is improved.

Description

Technical Field

[0001] The invention relates to the technical field of adapalene gel, in particular to adapalene gel and a production process. Background Art

[0002] Adapalene gel is a topical retinoic acid drug, mainly used to treat mild to moderate acne vulgaris. Adapalene can inhibit the release of inflammatory mediators, reduce the infiltration of inflammatory cells, thereby relieving the redness, swelling and pain of acne, and can also inhibit the excessive secretion of sebaceous glands, reduce the oil on the skin surface, to prevent the further development and recovery of acne. It has a certain effect of promoting skin repair and regeneration, can stimulate the synthesis of collagen, and reduce the scars and pigmentation left after acne. The existing adapalene gel and production process can basically meet the daily use needs, but there are still certain shortcomings. First, the existing adapalene gel is limited by the traditional formula, and its smell is often the original smell of the formula raw materials, which may cause olfactory stimulation to the user; second, the existing adapalene gel has insufficient permeability and cannot treat the deeper layer of the skin, affecting the use effect; third, the existing production process will directly fill and package after mixing, and the gel texture is relatively rough, which affects the user's use experience; therefore, it is necessary to design adapalene gel and production process. Summary of the invention

[0003] The purpose of the present invention is to provide adapalene gel and a production process to solve the problems raised in the above background technology.

[0004] To achieve the above purpose, the present invention provides the following technical scheme: adapalene gel, which comprises carbomer 980, poloxamer 188, propylene glycol, disodium edetate, phenoxyethanol, methylparaben, sodium hydroxide, purified water, azone and plant essential oil, wherein the weight proportions of the components are respectively: 40-50 parts of carbomer 980, 2-5 parts of poloxamer 188, 20-30 parts of propylene glycol, 1-3 parts of disodium edetate, 1-2 parts of phenoxyethanol, 1-2 parts of methylparaben, 1-3 parts of sodium hydroxide, 15-25 parts of purified water, 1-3 parts of azone and 1-2 parts of plant essential oil.

[0005] The production process of adapalene gel comprises the following steps: step 1, raw material preparation; step 2, adapalene dispersion preparation; step 3, active phase preparation; step 4, auxiliary material processing; step 5, gel matrix preparation; step 6, gelation and adjustment; step 7, ultrasonic dispersion treatment; step 8, quality inspection and packaging;

[0006] Wherein in the above step 1, 40-50 parts of Carbomer 980, 2-5 parts of Poloxamer 188, 20-30 parts of Propylene Glycol, 1-3 parts of Disodium Edetate, 1-2 parts of Phenoxyethanol, 1-2 parts of Methylparaben, 1-3 parts of Sodium Hydroxide, 15-25 parts of Purified Water, 1-3 parts of Azone and 1-2 parts of Plant Essential Oil are weighed respectively according to the weight of each group and set aside;

[0007] In the above step 2, the adapalene and poloxamer 188 prepared in the above step 1 are added to ethanol, and the liquid is spray-dried after heating and stirring to obtain an adapalene dispersion for later use;

[0008] In the above step 3, the adapalene dispersion prepared in the above step 2 and the propylene glycol prepared in the step 1 are mixed and stirred uniformly to obtain an active phase for standby use;

[0009] In the above step 4, the carbomer 980, propylene glycol, disodium edetate, phenoxyethanol and methylparaben prepared in the above step 1 are purified or diluted for later use;

[0010] In the above step 5, the carbomer 980, purified water, disodium edetate, phenoxyethanol, methylparaben, azone and plant essential oil prepared in the above step 1 are mixed and stirred evenly, and then sodium hydroxide is added to adjust the pH value to an appropriate range for standby use;

[0011] In the above step 6, the active phase prepared in the above step 3 and the gel matrix prepared in the above step 4 are mixed and stirred evenly for later use;

[0012] In the above step 7, the gel prepared in the above step 5 is added into an ultrasonic dispersion device for dispersion to obtain a finer and more uniform gel;

[0013] In the above step eight, the prepared adapalene gel is subjected to quality inspection to ensure that its quality meets the requirements, and then the qualified gel product is packaged, labeled and provided with instructions.

[0014] As a further technical solution of the present invention, in the step 2, the specific operation of preparing the adapalene dispersion is to add the adapalene and poloxamer 188 prepared in the step 1 to ethanol, then heat to 55-65° C., stir until the raw materials are completely dispersed, and then transfer the liquid into a spray drying equipment for spray drying. The spray drying conditions are 105-115° C., a gas flow rate of 400-600 L / h, and a spray flow rate of 15-25 ml / min, so as to obtain an adapalene dispersion with a particle size D90 less than 5 μm.

[0015] As a further technical solution of the present invention, in step 4, the specific process of the treatment is to disperse Carbomer 980 in an appropriate amount of water, and then heat it to 260° C. for 30 minutes, with appropriate stirring during the process.

[0016] As a further technical solution of the present invention, in the step 4, propylene glycol is filtered and sorted to remove impurities; and appropriate amounts of water are added to disodium edetate, phenoxyethanol and methylparaben to dissolve and dilute them.

[0017] As a further technical solution of the present invention, in the step 5, the specific process of preparing the gel matrix is ​​to mix the treated carbomer 980 and propylene glycol, add disodium edetate, phenoxyethanol and methylparaben after stirring evenly, stir evenly again, then add azone and plant essential oil, mix and stir evenly and set aside.

[0018] As a further technical solution of the present invention, in step six, the prepared active phase is slowly added to the gel matrix and continuously stirred to be evenly dispersed in the gel matrix. Water or other solvents can be added to adjust the viscosity and fluidity of the gel according to actual conditions.

[0019] As a further technical solution of the present invention, in step six, after the active phase and the gel matrix are mixed, the pH value is detected, and then sodium hydroxide solution is added to adjust the pH value to meet product requirements.

[0020] As a further technical solution of the present invention, in step seven, the specific operation of ultrasonic dispersion treatment is to add the gel into an ultrasonic dispersion device, the ultrasonic frequency of the ultrasonic dispersion device is 20 to 50 Hz, the single ultrasonic time is between 0.3 and 0.8, and the temperature is controlled at 30 to 50°C.

[0021] As a further technical solution of the present invention, in step eight, the quality inspection includes product appearance, viscosity, pH value, drug content, etc., and the product label and instructions indicate the product name, specifications, usage, dosage, expiration date and other information.

[0022] Compared with the prior art, the present invention has the following beneficial effects: the adapalene gel and production process, through the plant essential oil added in the process of preparing the gel matrix, the natural fragrance contained in the plant essential oil masks the irritating odors of various auxiliary materials in the product, thereby avoiding olfactory stimulation to the user, and at the same time, when the user uses it, these fragrances act on the brain through the olfactory system, so that the user can be mentally relaxed; at the same time, through the azone added in the process of preparing the gel matrix, the effect of the product penetrating the skin is effectively improved, so that the product can treat the deep skin of the acne location, and the use effect of the product is improved; after the adapalene gel is prepared, it is dispersed using an ultrasonic dispersion device, so that the texture of the gel is more delicate and uniform, and the user experience is effectively improved. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 It is a flow chart of the preparation method of the present invention. DETAILED DESCRIPTION

[0024] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0025] Please see attached Figure 1 , a technical solution provided by the present invention:

[0026] Embodiment 1:

[0027] The invention discloses an adapalene gel, wherein the formula includes carbomer 980, poloxamer 188, propylene glycol, disodium edetate, phenoxyethanol, methylparaben, sodium hydroxide, purified water, azone and plant essential oil, and the weight proportions of the components are respectively: 40 parts of carbomer 980, 2 parts of poloxamer 188, 20 parts of propylene glycol, 1 part of disodium edetate, 1 part of phenoxyethanol, 1 part of methylparaben, 1 part of sodium hydroxide, 25 parts of purified water, 1 part of azone and 1 part of plant essential oil.

[0028] The production process of adapalene gel comprises the following steps: step 1, raw material preparation; step 2, adapalene dispersion preparation; step 3, active phase preparation; step 4, auxiliary material processing; step 5, gel matrix preparation; step 6, gelation and adjustment; step 7, ultrasonic dispersion treatment; step 8, quality inspection and packaging;

[0029] Wherein in the above step 1, 40 parts of Carbomer 980, 2 parts of Poloxamer 188, 20 parts of propylene glycol, 1 part of disodium edetate, 1 part of phenoxyethanol, 1 part of methylparaben, 1 part of sodium hydroxide, 25 parts of purified water, 1 part of Azone and 1 part of plant essential oil are weighed respectively according to the weight parts of each group, and set aside;

[0030] Wherein in the above step 2, the adapalene and poloxamer 188 prepared in the above step 1 are added to ethanol, and the liquid is spray-dried after heating and stirring to obtain an adapalene dispersion for standby use; the specific operation of preparing the adapalene dispersion is to add the adapalene and poloxamer 188 prepared in step 1 to ethanol, and then heat to 55° C., stir until the raw materials are completely dispersed, and then transfer the liquid into a spray drying equipment for spray drying, the spray drying conditions are 105° C., the gas flow rate is 400 L / h, and the spray flow rate is 15 ml / min, so as to obtain an adapalene dispersion, and its particle size D90 is less than 5 μm;

[0031] In the above step 3, the adapalene dispersion prepared in the above step 2 and the propylene glycol prepared in the step 1 are mixed and stirred uniformly to obtain an active phase for standby use;

[0032] In the above step 4, the carbomer 980, propylene glycol, disodium edetate, phenoxyethanol and methylparaben prepared in the above step 1 are purified or diluted for standby use; the specific process of the treatment is to disperse the carbomer 980 in an appropriate amount of water, and then heat it to 260° C. for 30 minutes, stirring appropriately during the process; filter and sort the propylene glycol to remove impurities; disodium edetate, phenoxyethanol and methylparaben are respectively added with appropriate amounts of water for dissolution and dilution;

[0033] Wherein, in the above step 5, the carbomer 980, purified water, disodium edetate, phenoxyethanol, methylparaben, azone and plant essential oil prepared in the above step 1 are mixed and stirred evenly, and then sodium hydroxide is added to adjust the pH value to an appropriate range for standby use; the specific process of preparing the gel matrix is ​​as follows: the treated carbomer 980 and propylene glycol are mixed, and after stirring evenly, disodium edetate, phenoxyethanol and methylparaben are added, and stirred evenly again, and then azone and plant essential oil are added, and the mixture is mixed and stirred evenly for standby use;

[0034] In the above step 6, the active phase prepared in the above step 3 and the gel matrix prepared in the above step 4 are mixed and stirred evenly for use; the prepared active phase is slowly added to the gel matrix, and is continuously stirred to be evenly dispersed in the gel matrix, and water or other solvents can be added according to actual conditions to adjust the viscosity and fluidity of the gel; after the active phase and the gel matrix are mixed, the pH value is detected, and then sodium hydroxide solution is added to adjust the pH value to meet the product requirements;

[0035] In the above step 7, the gel prepared in the above step 5 is added to the ultrasonic dispersion device for dispersion to obtain a more delicate and uniform gel; the specific operation of the ultrasonic dispersion treatment is to add the gel to the ultrasonic dispersion device, the ultrasonic frequency of the ultrasonic dispersion device is 20 Hz, the single ultrasonic time is 0.3, and the temperature is controlled at 30°C;

[0036] In the above step eight, the prepared adapalene gel is subjected to quality inspection to ensure that its quality meets the requirements, and then the qualified gel product is packaged and labeled and provided with instructions; the quality inspection includes product appearance, viscosity, pH value, drug content, etc. The product label and instructions indicate the product name, specifications, usage, dosage, expiration date and other information.

[0037] Embodiment 2:

[0038] The invention discloses an adapalene gel, wherein the formula includes carbomer 980, poloxamer 188, propylene glycol, disodium edetate, phenoxyethanol, methylparaben, sodium hydroxide, purified water, azone and plant essential oil, and the weight proportions of the components are respectively: 50 parts of carbomer 980, 5 parts of poloxamer 188, 30 parts of propylene glycol, 3 parts of disodium edetate, 2 parts of phenoxyethanol, 2 parts of methylparaben, 3 parts of sodium hydroxide, 20 parts of purified water, 3 parts of azone and 2 parts of plant essential oil.

[0039] The production process of adapalene gel comprises the following steps: step 1, raw material preparation; step 2, adapalene dispersion preparation; step 3, active phase preparation; step 4, auxiliary material processing; step 5, gel matrix preparation; step 6, gelation and adjustment; step 7, ultrasonic dispersion treatment; step 8, quality inspection and packaging;

[0040] Wherein in the above step 1, 50 parts of Carbomer 980, 5 parts of Poloxamer 188, 30 parts of propylene glycol, 3 parts of disodium edetate, 2 parts of phenoxyethanol, 2 parts of methylparaben, 3 parts of sodium hydroxide, 20 parts of purified water, 3 parts of Azone and 2 parts of plant essential oil are weighed according to the weight of each group and set aside;

[0041] In the above step 2, the adapalene and poloxamer 188 prepared in the above step 1 are added to ethanol, and the liquid is spray-dried after heating and stirring to obtain an adapalene dispersion for standby use; the specific operation of preparing the adapalene dispersion is to add the adapalene and poloxamer 188 prepared in step 1 to ethanol, and then heat to 60° C., stir until the raw materials are completely dispersed, and then transfer the liquid into a spray drying equipment for spray drying, the spray drying conditions are 110° C., the gas flow rate is 600 L / h, and the spray flow rate is 25 ml / min, so that the adapalene dispersion can be obtained, and its particle size D90 is less than 5 μm

[0042] In the above step 3, the adapalene dispersion prepared in the above step 2 and the propylene glycol prepared in the step 1 are mixed and stirred uniformly to obtain an active phase for standby use;

[0043] In the above step 4, the carbomer 980, propylene glycol, disodium edetate, phenoxyethanol and methylparaben prepared in the above step 1 are purified or diluted for standby use; the specific process of the treatment is to disperse the carbomer 980 in an appropriate amount of water, and then heat it to 260° C. for 30 minutes, stirring appropriately during the process; filter and sort the propylene glycol to remove impurities; disodium edetate, phenoxyethanol and methylparaben are respectively added with appropriate amounts of water for dissolution and dilution;

[0044] Wherein, in the above step 5, the carbomer 980, purified water, disodium edetate, phenoxyethanol, methylparaben, azone and plant essential oil prepared in the above step 1 are mixed and stirred evenly, and then sodium hydroxide is added to adjust the pH value to an appropriate range for standby use; the specific process of preparing the gel matrix is ​​as follows: the treated carbomer 980 and propylene glycol are mixed, and after stirring evenly, disodium edetate, phenoxyethanol and methylparaben are added, and stirred evenly again, and then azone and plant essential oil are added, and the mixture is mixed and stirred evenly for standby use;

[0045] In the above step 6, the active phase prepared in the above step 3 and the gel matrix prepared in the above step 4 are mixed and stirred evenly for use; the prepared active phase is slowly added to the gel matrix, and is continuously stirred to be evenly dispersed in the gel matrix, and water or other solvents can be added according to actual conditions to adjust the viscosity and fluidity of the gel; after the active phase and the gel matrix are mixed, the pH value is detected, and then sodium hydroxide solution is added to adjust the pH value to meet the product requirements;

[0046] In the above step 7, the gel prepared in the above step 5 is added to the ultrasonic dispersion device for dispersion to obtain a more delicate and uniform gel; the specific operation of the ultrasonic dispersion treatment is to add the gel to the ultrasonic dispersion device, the ultrasonic frequency of the ultrasonic dispersion device is 50 Hz, the single ultrasonic time is 0.5, and the temperature is controlled at 50°C;

[0047] In the above step eight, the prepared adapalene gel is subjected to quality inspection to ensure that its quality meets the requirements, and then the qualified gel product is packaged and labeled and provided with instructions; the quality inspection includes product appearance, viscosity, pH value, drug content, etc. The product label and instructions indicate the product name, specifications, usage, dosage, expiration date and other information.

[0048] Embodiment 3:

[0049] The invention discloses an adapalene gel, wherein the formula includes carbomer 980, poloxamer 188, propylene glycol, disodium edetate, phenoxyethanol, methylparaben, sodium hydroxide, purified water, azone and plant essential oil, and the weight proportions of the components are respectively: 45 parts of carbomer 980, 3 parts of poloxamer 188, 25 parts of propylene glycol, 2 parts of disodium edetate, 1 part of phenoxyethanol, 1 part of methylparaben, 2 parts of sodium hydroxide, 25 parts of purified water, 2 parts of azone and 2 parts of plant essential oil.

[0050] The production process of adapalene gel comprises the following steps: step 1, raw material preparation; step 2, adapalene dispersion preparation; step 3, active phase preparation; step 4, auxiliary material processing; step 5, gel matrix preparation; step 6, gelation and adjustment; step 7, ultrasonic dispersion treatment; step 8, quality inspection and packaging;

[0051] Wherein in the above step 1, 45 parts of Carbomer 980, 3 parts of Poloxamer 188, 25 parts of Propylene Glycol, 2 parts of Disodium Edetate, 1 part of Phenoxyethanol, 1 part of Methylparaben, 2 parts of Sodium Hydroxide, 25 parts of Purified Water, 2 parts of Azone and 2 parts of Plant Essential Oil are weighed respectively according to the weight of each group and set aside;

[0052] Wherein in the above step 2, the adapalene and poloxamer 188 prepared in the above step 1 are added to ethanol, and the liquid is spray-dried after heating and stirring to obtain an adapalene dispersion for standby use; the specific operation of preparing the adapalene dispersion is to add the adapalene and poloxamer 188 prepared in step 1 to ethanol, and then heat to 65° C., stir until the raw materials are completely dispersed, and then transfer the liquid into a spray drying equipment for spray drying, the spray drying conditions are 115° C., the gas flow rate is 500 L / h, and the spray flow rate is 25 ml / min, so as to obtain an adapalene dispersion, and its particle size D90 is less than 5 μm;

[0053] In the above step 3, the adapalene dispersion prepared in the above step 2 and the propylene glycol prepared in the step 1 are mixed and stirred uniformly to obtain an active phase for standby use;

[0054] In the above step 4, the carbomer 980, propylene glycol, disodium edetate, phenoxyethanol and methylparaben prepared in the above step 1 are purified or diluted for standby use; the specific process of the treatment is to disperse the carbomer 980 in an appropriate amount of water, and then heat it to 260° C. for 30 minutes, stirring appropriately during the process; filter and sort the propylene glycol to remove impurities; disodium edetate, phenoxyethanol and methylparaben are respectively added with appropriate amounts of water for dissolution and dilution;

[0055] Wherein, in the above step 5, the carbomer 980, purified water, disodium edetate, phenoxyethanol, methylparaben, azone and plant essential oil prepared in the above step 1 are mixed and stirred evenly, and then sodium hydroxide is added to adjust the pH value to an appropriate range for standby use; the specific process of preparing the gel matrix is ​​as follows: the treated carbomer 980 and propylene glycol are mixed, and after stirring evenly, disodium edetate, phenoxyethanol and methylparaben are added, and stirred evenly again, and then azone and plant essential oil are added, and the mixture is mixed and stirred evenly for standby use;

[0056] In the above step 6, the active phase prepared in the above step 3 and the gel matrix prepared in the above step 4 are mixed and stirred evenly for use; the prepared active phase is slowly added to the gel matrix, and is continuously stirred to be evenly dispersed in the gel matrix, and water or other solvents can be added according to actual conditions to adjust the viscosity and fluidity of the gel; after the active phase and the gel matrix are mixed, the pH value is detected, and then sodium hydroxide solution is added to adjust the pH value to meet the product requirements;

[0057] In the above step 7, the gel prepared in the above step 5 is added to the ultrasonic dispersion device for dispersion to obtain a more delicate and uniform gel; the specific operation of the ultrasonic dispersion treatment is to add the gel to the ultrasonic dispersion device, the ultrasonic frequency of the ultrasonic dispersion device is 40 Hz, the single ultrasonic time is 0.6, and the temperature is controlled at 40°C;

[0058] In the above step eight, the prepared adapalene gel is subjected to quality inspection to ensure that its quality meets the requirements, and then the qualified gel product is packaged and labeled and provided with instructions; the quality inspection includes product appearance, viscosity, pH value, drug content, etc. The product label and instructions indicate the product name, specifications, usage, dosage, expiration date and other information.

[0059] The adapalene gel obtained in the above examples was tested respectively and compared with the adapalene gel on the market. The results are shown in the following table:

[0060] Average particle size (nm) pH Example 1 13 4.8 Example 2 14 4.9 Example 3 12 5.1 Comparative Example 30 5.8

[0061] Based on the above, the advantages of the present invention are that, by adding the plant essential oil in the process of preparing the gel matrix, the natural aroma contained in the plant essential oil masks the pungent smell of various auxiliary materials in the product, thereby avoiding olfactory stimulation to the user. At the same time, when the user uses it, these aromas act on the brain through the olfactory system, so that the user can be mentally relaxed; at the same time, by adding azone in the process of preparing the gel matrix, the effect of the product penetrating the skin is effectively improved, so that the product can treat the deep skin of the acne location, thereby improving the use effect of the product; after the adapalene gel is prepared, it is dispersed using an ultrasonic dispersion device, so that the texture of the gel is more delicate and uniform, and the user experience is effectively improved.

[0062] It will be apparent to those skilled in the art that the invention is not limited to the details of the exemplary embodiments described above and that the invention can be implemented in other specific forms without departing from the spirit or essential features of the invention. Therefore, the embodiments should be considered exemplary and non-limiting in all respects, and the scope of the invention is defined by the appended claims rather than the foregoing description, and it is intended that all variations falling within the meaning and scope of the equivalent elements of the claims be included in the invention. Any reference numeral in a claim should not be considered as limiting the claim to which it relates.

Claims

1. Adapalene gel, the formula comprising: Carbomer 980, poloxamer 188, propylene glycol, disodium edetate, phenoxyethanol, methylparaben, sodium hydroxide, purified water, azone and plant essential oil, characterized in that the weight proportions of the components are respectively: 40-50 parts of carbomer 980, 2-5 parts of poloxamer 188, 20-30 parts of propylene glycol, 1-3 parts of disodium edetate, 1-2 parts of phenoxyethanol, 1-2 parts of methylparaben, 1-3 parts of sodium hydroxide, 15-25 parts of purified water, 1-3 parts of azone and 1-2 parts of plant essential oil.

2. The production process of adapalene gel comprises the following steps: Step 1, raw material preparation; Step 2, adapalene dispersion preparation; Step 3, active phase preparation; Step 4, auxiliary material processing; Step 5, preparation of gel matrix; Step 6, gelation and adjustment; Step 7, ultrasonic dispersion treatment; Step 8, quality inspection and packaging; It is characterized in that: Wherein in the above step 1, 40-50 parts of Carbomer 980, 2-5 parts of Poloxamer 188, 20-30 parts of Propylene Glycol, 1-3 parts of Disodium Edetate, 1-2 parts of Phenoxyethanol, 1-2 parts of Methylparaben, 1-3 parts of Sodium Hydroxide, 15-25 parts of Purified Water, 1-3 parts of Azone and 1-2 parts of Plant Essential Oil are weighed respectively according to the weight of each group and set aside; In the above step 2, the adapalene and poloxamer 188 prepared in the above step 1 are added to ethanol, and the liquid is spray-dried after heating and stirring to obtain an adapalene dispersion for later use; In the above step 3, the adapalene dispersion prepared in the above step 2 and the propylene glycol prepared in the step 1 are mixed and stirred uniformly to obtain an active phase for standby use; In the above step 4, the carbomer 980, propylene glycol, disodium edetate, phenoxyethanol and methylparaben prepared in the above step 1 are purified or diluted for later use; In the above step 5, the carbomer 980, purified water, disodium edetate, phenoxyethanol, methylparaben, azone and plant essential oil prepared in the above step 1 are mixed and stirred evenly, and then sodium hydroxide is added to adjust the pH value to an appropriate range for standby use; In the above step 6, the active phase prepared in the above step 3 and the gel matrix prepared in the above step 4 are mixed and stirred evenly for later use; In the above step 7, the gel prepared in the above step 5 is added into an ultrasonic dispersion device for dispersion to obtain a finer and more uniform gel; In the above step eight, the prepared adapalene gel is subjected to quality inspection to ensure that its quality meets the requirements, and then the qualified gel product is packaged and labeled and provided with instructions.

3. The adapalene gel production process according to claim 2, characterized in that: In the step 2, the specific operation of preparing the adapalene dispersion is to add the adapalene and poloxamer 188 prepared in the step 1 into ethanol, then heat to 55-65° C., stir until the raw materials are completely dispersed, and then transfer the liquid into a spray drying device for spray drying. The spray drying conditions are 105-115° C., a gas flow rate of 400-600 L / h, and a spray flow rate of 15-25 ml / min, so as to obtain an adapalene dispersion with a particle size D90 less than 5 μm.

4. The adapalene gel production process according to claim 2, characterized in that: In step 4, the specific process of the treatment is to disperse Carbomer 980 in an appropriate amount of water, and then heat it to 260° C. for 30 minutes, stirring appropriately during the process.

5. The adapalene gel production process according to claim 2, characterized in that: In the step 4, propylene glycol is filtered and processed to remove impurities; and appropriate amounts of water are added to disodium edetate, phenoxyethanol and methylparaben to dissolve and dilute them.

6. The adapalene gel production process according to claim 2, characterized in that: In the step 5, the specific process of preparing the gel matrix is ​​to mix the treated Carbomer 980 and propylene glycol, add disodium edetate, phenoxyethanol and methylparaben after stirring evenly, stir evenly again, then add azone and plant essential oil, mix and stir evenly and set aside.

7. The adapalene gel production process according to claim 2, characterized in that: In the step six, the prepared active phase is slowly added to the gel matrix and continuously stirred to be evenly dispersed in the gel matrix. Water or other solvents may be added to adjust the viscosity and fluidity of the gel according to actual conditions.

8. The adapalene gel production process according to claim 2, characterized in that: In the step six, after the active phase and the gel matrix are mixed, the pH value is detected, and then sodium hydroxide solution is added to adjust the pH value to meet the product requirements.

9. The adapalene gel production process according to claim 2, characterized in that: In the step seven, the specific operation of ultrasonic dispersion treatment is to add the gel into an ultrasonic dispersion device, the ultrasonic frequency of the ultrasonic dispersion device is 20 to 50 Hz, the single ultrasonic time is between 0.3 and 0.8, and the temperature is controlled at 30 to 50°C.

10. The adapalene gel production process according to claim 2, characterized in that: In step eight, quality inspection includes product appearance, viscosity, pH value, drug content, etc. The product label and instructions indicate product name, specifications, usage, dosage, expiration date and other information.

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