CN110840834B - Preparation process of 30% concentration liquid slow-release salicylic acid - Google Patents
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Abstract
The invention discloses a preparation process of liquid slow-release salicylic acid with the concentration of 30%, which comprises the following steps: under the condition of a first set temperature, adding salicylic acid into a glycerol aqueous solution, uniformly mixing, cooling to a second set temperature, homogenizing until the solution is transparent, heating to a third set temperature, sequentially adding poloxamer and polyethylene glycol, uniformly mixing, cooling to a fourth set temperature, adding a skin feel modifier, and uniformly mixing; wherein the first set temperature is not lower than 60 ℃, the second set temperature is lower than 60 ℃, the third set temperature is not lower than 60 ℃, and the fourth set temperature is higher than 40 ℃. The invention can obviously increase the solubility of the salicylic acid in the water phase so as to improve the bioavailability of the salicylic acid, and can obviously reduce the irritation of the salicylic acid to the skin so as to solve the technical problem that the majority of people cannot tolerate the high-concentration salicylic acid.
Description
Technical Field
The invention belongs to the technical field of dermatology external preparations and preparation thereof, and relates to a preparation process of liquid sustained-release salicylic acid with a concentration of 30%.
Background
The information in this background section is only for enhancement of understanding of the general background of the invention and is not necessarily to be construed as an admission or any form of suggestion that this information forms the prior art that is already known to a person of ordinary skill in the art.
Salicylic acid, also known as salicylic acid, is a Beta Hydroxy Acid (BHA) extracted from willow or poplar, has a molecular formula of C7H6O3, is in the form of white fine needle crystals or white crystalline powder, and has antipyretic, analgesic and anti-inflammatory effects. Salicylic acid has a lipophilic character, is capable of penetrating pores and dissolving dead skin cells, and is frequently widely used in cosmetics as an exfoliating agent. In particular, salicylic acid can be used to treat dandruff, comedones, blackheads, acne, skin wrinkles, skin pigmentation, blemishes, and other skin-related conditions. Because salicylic acid is fat-soluble and insoluble in water, and is easily soluble in organic solvents such as methanol, ethanol, acetone, ether and the like, the prior art generally adopts a large amount of ethanol to dissolve salicylic acid, although the solubility of the salicylic acid can be increased, the increase of the ethanol can also generate obvious stimulation to the skin, and the salicylic acid is easily recrystallized after the ethanol is volatilized, so that the utilization rate of the salicylic acid is reduced.
For water-soluble slow-release salicylic acid, a widely applied technology is beta-cyclodextrin inclusion or chitosan inclusion. The product added with the salicylic acid raw material has mild property, avoids the problem of much irritation, can be accepted by most people, is much more convenient to prepare, but has less effect than that of an alcohol-soluble type after long-term observation, so that the effect can be reflected by longer service cycle. At present, the salicylic acid product can be prepared on the basis of preparing temperature-sensitive gel by poloxamer, and the method has the advantage of slow release, if the gelling temperature of the skin temperature of a human body is fully considered on the components, the finished product is liquid or semisolid at normal temperature, and a layer of hydrogel is formed on the skin to slowly administer the medicine to the skin. This prepared form of the salicylic acid product has milder properties. The concentration of the water-soluble salicylic acid prepared by means of poloxamer only reaches 5%, and the inventor of the invention finds that the water-soluble salicylic acid prepared by means of poloxamer cannot be dissolved at high concentration, and particularly, the water-soluble salicylic acid with the concentration of 30% is difficult to prepare.
Disclosure of Invention
In order to solve the defects of the prior art, the invention aims to provide a preparation process of liquid sustained-release salicylic acid with the concentration of 30%, the preparation process can obviously increase the solubility of the salicylic acid in a water phase so as to improve the bioavailability of the salicylic acid, and can obviously reduce the irritation of the salicylic acid to the skin so as to solve the technical problem that the vast population cannot tolerate the high-concentration salicylic acid.
In order to achieve the purpose, the technical scheme of the invention is as follows:
on one hand, the preparation process of the liquid sustained-release salicylic acid comprises the steps of adding the salicylic acid into a glycerol aqueous solution under the condition of a first set temperature, uniformly mixing, cooling to a second set temperature, homogenizing until the solution is transparent, heating to a third set temperature, sequentially adding poloxamer and polyethylene glycol, uniformly mixing, cooling to a fourth set temperature, adding a skin feel modifier, and uniformly mixing; wherein the first set temperature is not lower than 60 ℃, the second set temperature is lower than 60 ℃, the third set temperature is not lower than 60 ℃, and the fourth set temperature is higher than 40 ℃.
In the experimental process, the inventor of the invention finds that the solubility of salicylic acid can be greatly improved through a specific dissolving process (feeding sequence and temperature change) in a specific proportioning combination of the three specific components, and the concentration of the prepared liquid sustained-release salicylic acid can reach as high as 30%.
On the other hand, the preparation process of the liquid slow-release salicylic acid with the concentration of 30% comprises the step of preparing the liquid slow-release salicylic acid with the concentration of 30% by adopting the preparation process of the liquid slow-release salicylic acid.
In a third aspect, the liquid slow-release salicylic acid is obtained by the preparation process.
The invention has the beneficial effects that:
experiments show that when glycerol, poloxamer and polyethylene glycol are used as solubilizers and are prepared according to a specific preparation sequence and temperature, the solubility of salicylic acid can be greatly increased, and the concentration of the dissolved salicylic acid can reach 30%.
Detailed Description
It is to be understood that the following detailed description is exemplary and is intended to provide further explanation of the invention as claimed. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.
It is noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of exemplary embodiments according to the invention. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, and it should be understood that when the terms "comprises" and/or "comprising" are used in this specification, they specify the presence of stated features, steps, operations, devices, components, and/or combinations thereof, unless the context clearly indicates otherwise.
In view of the problem that water-soluble salicylic acid cannot be dissolved at high concentration, the invention provides a preparation process of liquid sustained-release salicylic acid with the concentration of 30%.
The invention provides a typical embodiment of a preparation process of liquid slow-release salicylic acid, which comprises the steps of adding salicylic acid into a glycerol aqueous solution under the condition of a first set temperature, uniformly mixing, cooling to a second set temperature, homogenizing until the solution is transparent, heating to a third set temperature, sequentially adding poloxamer and polyethylene glycol, uniformly mixing, cooling to a fourth set temperature, adding a skin feel regulator, and uniformly mixing; wherein the first set temperature is not lower than 60 ℃, the second set temperature is lower than 60 ℃, the third set temperature is not lower than 60 ℃, and the fourth set temperature is higher than 40 ℃.
In the experimental process, the inventor of the invention finds that the solubility of salicylic acid can be greatly improved through a specific dissolving process (feeding sequence and temperature change) in a specific proportioning combination of the three specific components, and the concentration of the prepared liquid sustained-release salicylic acid can reach as high as 30%.
In one or more embodiments of this embodiment, the glycerol in the aqueous glycerol solution is present in an amount of 15 to 20% by weight.
In the series of embodiments, the mass fraction of glycerol in the glycerol aqueous solution is 17-18%.
In one or more embodiments of this embodiment, the aqueous glycerol solution is prepared by: heating glycerol and water to 60-100 ℃, and stirring until the glycerol and the water are dissolved and transparent. When the temperature is 88-92 ℃, the dissolving effect is better.
In the series of embodiments, the stirring time is 10-50 min. When the stirring time is 29-31 min, the stirring time is shortened on the premise that the solution is completely dissolved and transparent.
In one or more embodiments of this embodiment, the first set temperature is 60 to 100 ℃. When the temperature is 88-92 ℃, the dissolving effect is better.
In one or more embodiments of the present disclosure, the time for stirring and mixing after adding salicylic acid is 40 to 80 min. When the stirring and mixing time is 59-61 min, the salicylic acid can be ensured to be dissolved, and the stirring time is shortened.
In one or more embodiments of this embodiment, the second set temperature is 30 to 60 ℃. When the temperature is 44-46 ℃, the dissolving effect is better.
In one or more embodiments of the present invention, the homogenizing method is to homogenize for 1-5 times by using a high-pressure homogenizer. The effect is better when homogenizing for 3 times.
In one or more embodiments of this embodiment, the third set point temperature is 60 to 100 ℃. When the temperature is 88-92 ℃, the effect is better.
In one or more embodiments of the embodiment, poloxamer and polyethylene glycol are sequentially added, mixed uniformly and then kept warm for 20-100 min. When the heat preservation time is 58-62 min, the effect is better.
In one or more embodiments of this embodiment, the polyethylene glycol is polyethylene glycol 400.
In one or more embodiments of this embodiment, the fourth set temperature is between 80 ℃ and 40 ℃. When the temperature is 63-67 ℃, the effect is better.
In one or more embodiments of this embodiment, the skin feel modifier is menthol.
In one or more embodiments of the embodiment, the adding mass ratio of the glycerol, the salicylic acid, the poloxamer and the polyethylene glycol is 1:3: 0.4-1: 0.2-0.6.
In one or more embodiments of the embodiment, the adding mass ratio of the salicylic acid to the skin feeling modifier is 3: 0.1-0.4.
The invention also provides a preparation process of the liquid slow-release salicylic acid with the concentration of 30%, which comprises the step of preparing the liquid slow-release salicylic acid with the concentration of 30% by adopting the preparation process of the liquid slow-release salicylic acid.
In a third embodiment of the invention, the liquid sustained-release salicylic acid is obtained by the preparation process.
In one or more embodiments of the present disclosure, the salicylic acid is 15 to 30% by mass, the poloxamer is 7.5 to 8.5% by mass, and the glycerol is 9.5 to 10.5% by mass.
In order to make the technical solution of the present invention more clearly understood by those skilled in the art, the technical solution of the present invention will be described in detail below with reference to specific examples and comparative examples.
Example 1
The preparation process of the liquid slow-release salicylic acid comprises the following steps:
1: 460 parts of water and 100 parts of glycerol are mixed, heated to 90 ℃, and stirred for 30min under the condition of heat preservation until the materials are completely dissolved and transparent.
2: adding 300 parts of salicylic acid, continuously stirring until the salicylic acid is completely dissolved, and keeping the temperature at 90 ℃ and stirring for 60 minutes.
3: cooling to 45 deg.C, homogenizing for 3 times with high pressure homogenizer until it is completely transparent.
4: heating to 90 deg.C, adding 80 parts of poloxamer, adding 40 parts of PEG-400, dissolving completely, and keeping the temperature for 60 min.
5: cooling to 65 ℃, adding 20 parts of menthol, and stirring uniformly.
6: cooling to 40 ℃, and discharging.
Example 2
The preparation process of the liquid slow-release salicylic acid comprises the following steps:
1: 460 parts of water and 100 parts of glycerol are mixed, heated to 80 ℃, and stirred for 50min under the condition of heat preservation until the materials are completely dissolved and transparent.
2: adding 300 parts of salicylic acid, continuously stirring until the salicylic acid is completely dissolved, and keeping the temperature at 80 ℃ and stirring for 100 minutes.
3: cooling to 40 deg.C, homogenizing for 5 times with high pressure homogenizer until it is completely transparent.
4: heating to 80 deg.C, adding 70 parts of poloxamer and 40 parts of PEG-400, dissolving completely, and keeping the temperature for 60 min.
5: cooling to 65 ℃, adding 20 parts of menthol, and stirring uniformly.
6: cooling to 40 ℃, and discharging.
Example 3
The preparation process of the liquid slow-release salicylic acid comprises the following steps:
1: 460 parts of water and 100 parts of glycerol are mixed, heated to 80 ℃, and stirred for 50min under the condition of heat preservation until the materials are completely dissolved and transparent.
2: adding 300 parts of salicylic acid, continuously stirring until the salicylic acid is completely dissolved, and keeping the temperature at 70 ℃ and stirring for 180 minutes.
3: cooling to 40 deg.C, homogenizing for 5 times with high pressure homogenizer until it is completely transparent.
4: heating to 80 deg.C, adding 70 parts of poloxamer and 40 parts of PEG-400, dissolving completely, and keeping the temperature for 60 min.
5: cooling to 65 ℃, adding 20 parts of menthol, and stirring uniformly.
6: cooling to 40 ℃, and discharging.
The experimental results are as follows: the water-soluble slow-release salicylic acid can be obtained in three ways, and the water-soluble slow-release salicylic acid obtained in example 1 is used as the optimal effect.
Comparative example 1
This comparative example is the same as example 1, except that: the glycerol was omitted.
Comparative example 2
This comparative example is the same as example 1, except that: the poloxamer is omitted.
Comparative example 3
This comparative example is the same as example 1, except that: PEG-400 is omitted.
Comparative example 4
This comparative example is the same as example 1, except that: step 1, adding poloxamer; and 4, adding glycerol and then adding PEG-400.
Comparative example 5
This comparative example is the same as example 1, except that: step 1, adding PEG-400; and 4, adding glycerol and then adding poloxamer.
Comparative example 6
This comparative example is the same as example 1, except that: step 1, adding glycerol; and 4, adding PEG-400 and then adding poloxamer.
The solubility of the liquid sustained-release salicylic acid prepared in example 1 and comparative examples 1 to 3 is shown in Table 1.
TABLE 1 solubility of liquid sustained-release salicylic acids prepared in example 1 and comparative examples 1 to 3
| Glycerol | Poloxamers | PEG-400 | Solubility in water | |
| Example 1 | √ | √ | √ | 30% |
| Comparative example 1 | × | √ | √ | 5% |
| Comparative example 2 | √ | × | √ | 10% |
| Comparative example 3 | √ | √ | × | 5% |
The solubility of the liquid sustained-release salicylic acid prepared in example 1 and comparative examples 4 to 6 is shown in Table 2.
TABLE 2 solubility of liquid sustained-release salicylic acids prepared in example 1 and comparative examples 4 to 6
| Glycerol | Poloxamers | PEG-400 | Solubility in water | |
| Example 1 | Frist | Second | Third | 30% |
| Comparative example 4 | Second | Frist | Third | 10% |
| Comparative example 5 | Second | Third | Frist | 10% |
| Comparative example 6 | Frist | Third | Second | 20% |
As is apparent from tables 1 and 2, the solubility of the liquid sustained-release salicylic acid is affected by the composition of the solubilizer in example 1 and the addition sequence of the solubilizer, and the solubility of the liquid sustained-release salicylic acid can be increased only when glycerol, poloxamer and PEG-400 are selected as the solubilizers and added in the order of glycerol, poloxamer and PEG-400.
The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention, and various modifications and changes may be made by those skilled in the art. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.
Claims (17)
1. A preparation process of liquid slow-release salicylic acid is characterized in that salicylic acid is added into a glycerol aqueous solution under the condition of a first set temperature and mixed uniformly, the temperature is reduced to a second set temperature, the solution is homogenized until the solution is transparent, the solution is heated to a third set temperature, poloxamer and polyethylene glycol are sequentially added and mixed uniformly, then the solution is cooled to a fourth set temperature, and a skin feel regulator is added and mixed uniformly; wherein the first set temperature is not lower than 60 ℃, the second set temperature is lower than 60 ℃, the third set temperature is not lower than 60 ℃, and the fourth set temperature is higher than 40 ℃;
the mass fraction of glycerol in the glycerol aqueous solution is 17-18%;
the adding mass ratio of the glycerol to the salicylic acid to the poloxamer to the polyethylene glycol is 1:3: 0.7-0.8: 0.4.
2. The process for preparing a liquid sustained-release salicylic acid according to claim 1 wherein,
the preparation process of the glycerol aqueous solution comprises the following steps: heating glycerol and water to 60-100 ℃, and stirring until the glycerol and the water are dissolved and transparent.
3. The process for preparing liquid sustained-release salicylic acid according to claim 2 wherein the aqueous glycerol solution is prepared by the steps of: heating glycerol and water to 88-92 ℃.
4. The process for preparing liquid sustained-release salicylic acid according to claim 2 wherein the stirring time is 10-50 min.
5. The process for preparing the liquid sustained-release salicylic acid according to claim 4, wherein the stirring time is 29-31 min.
6. The process for preparing the liquid sustained-release salicylic acid according to claim 1, wherein the first set temperature is 60-100 ℃;
or the second set temperature is 30-60 ℃;
or, the third set temperature is 60-100 ℃;
alternatively, the fourth set temperature is between 80 ℃ and 40 ℃.
7. The process for preparing the liquid sustained-release salicylic acid according to claim 1, wherein the first set temperature is 88 to 92 ℃.
8. The process for preparing the liquid sustained-release salicylic acid according to claim 1, wherein the second set temperature is 44-46 ℃.
9. The process for preparing the liquid sustained-release salicylic acid according to claim 1, wherein the third set temperature is 88-92 ℃.
10. The process for preparing the liquid sustained-release salicylic acid according to claim 1, wherein the fourth set temperature is 63-67 ℃.
11. The process for preparing the liquid sustained-release salicylic acid according to claim 1, wherein the salicylic acid is added and then stirred for 40-80 min;
or sequentially adding poloxamer and polyethylene glycol, uniformly mixing, and keeping the temperature for 20-100 min;
or, the homogenizing method is to homogenize for 1 to 5 times by adopting a high-pressure homogenizer.
12. The process for preparing liquid sustained-release salicylic acid according to claim 11 wherein the time for mixing is 59-61 min.
13. The process for preparing the liquid sustained-release salicylic acid according to claim 11, wherein the heat preservation time is 58-62 min.
14. The process for preparing a liquid sustained-release salicylic acid according to claim 11 wherein homogenizing is carried out 3 times.
15. The preparation process of the liquid sustained-release salicylic acid according to claim 1, wherein the adding mass ratio of the salicylic acid to the skin feel modifier is 3: 0.1-0.4.
16. A preparation process of liquid slow-release salicylic acid with a concentration of 30% is characterized by comprising the step of preparing the liquid slow-release salicylic acid with the concentration of 30% by adopting the preparation process of the liquid slow-release salicylic acid as claimed in any one of claims 1-15.
17. A liquid slow-release salicylic acid, which is obtained by the preparation process of any one of claims 1-6.
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