Disclosure of Invention
The invention utilizes three components of lipoic acid, propolis and aloe extract to realize synergistic effect, can effectively resist and inhibit bacteria, can effectively inhibit and eliminate dental plaque, can effectively treat oral cavities such as halitosis and canker sore, can effectively relieve gingival bleeding, and has a relieving effect on diabetic mouth disease lesions.
In order to achieve the purpose, the invention adopts the following technical scheme:
in a first aspect, the present invention provides a mouthwash comprising a propolis extract, lipoic acid, and an aloe vera extract.
The propolis extract has the functions of diminishing inflammation and inhibiting bacteria, and harmful bacteria in the needle mouth cavity can play a role in inhibiting. The aloe extract can be used as a bacteriostatic agent, and the barbaloin and aloe polysaccharide contained in the aloe extract have the effects of diminishing swelling, promoting tissue regeneration, repairing tissue injury, promoting wound healing and the like, can promote wound healing, has obvious treatment effect on oral mucosal ulcer, and has a certain hypoglycemic effect according to research. Lipoic acid as an antioxidant promotes oral microcirculation, reduces bleeding from the gums, and prevents gingivitis. By utilizing mutual promotion among the lipoic acid, the propolis and the aloe extract, the three components play a synergistic role, so that the oral liquid has the effects of effectively resisting and inhibiting bacteria, effectively inhibiting and removing dental plaque, effectively treating oral cavity diseases such as halitosis and oral ulcer, effectively relieving gingival bleeding and relieving diabetic mouth disease lesions.
In the invention, the propolis extract and the aloe extract are extracted by adopting known methods in the field, and the propolis extract and the aloe extract extracted by different extraction methods do not cause the difference in the efficacy of the mouthwash of the invention, and do not influence the mouthwash of the invention.
According to the present invention, the mouthwash comprises 0.1 to 10% by mass of the propolis extract, for example, 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9% or 10%, preferably 0.1 to 3%, and further preferably 1%, and the specific points between the above values are not exhaustive, and the specific points included in the range are not limited to the space and for the sake of brevity.
According to the invention, the mouth wash comprises 0.1-10% by mass of lipoic acid, for example 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.8%, 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9% or 10%, preferably 0.1-3%, and further preferably 1.5%, and the specific values between the above values are limited by the space and for the sake of brevity, and the invention is not exhaustive of the specific values included in the range.
According to the present invention, the mouthwash comprises 0.1 to 30% by mass of aloe vera extract, for example, 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 10%, 12%, 13%, 15%, 16%, 18%, 20%, 22%, 23%, 25%, 26%, 28% or 30%, preferably 0.5 to 10%, and more preferably 5%, and the specific points between the above values are not limited to space and for the sake of brevity, and the invention is not exhaustive of the specific points included in the range.
In the invention, the lipoic acid, the propolis extract and the aloe extract are within the mass percentage range of the application, and the three substances can exert synergistic effect to the maximum extent so as to interact with each other, and especially have obvious relieving effect on diabetic mouth disease lesion.
According to the invention, the mouthwash also comprises auxiliary materials.
Preferably, the auxiliary material is any one or a combination of at least two of a sweetening agent, a solvent, a humectant, a freshener, a solubilization stabilizer, a pH regulator or an essence, preferably the combination of the solvent, the humectant, the solubilization stabilizer and the pH regulator, and further preferably the combination of the sweetening agent, the solvent, the humectant, the freshener, the solubilization stabilizer, the pH regulator and the essence.
The inventor surprisingly finds that the effect can be enhanced by adding the auxiliary materials, and the lipoic acid, the propolis extract and the aloe extract can be matched with each other, so that the efficacy is enhanced, the pain of patients with diabetes and mouth disease can be relieved while bacteriostasis is realized, and the auxiliary materials are safe and non-irritant through various skin tests.
Preferably, the solvent is ethanol.
According to the invention, the humectant is used for protecting oral mucosa and enabling the oral environment to be in a relatively humid state, and can well relieve dry mouth symptoms of diabetic patients, wherein the humectant is sorbitol and/or glycerol, and when the humectant is a mixture of sorbitol and glycerol, the sorbitol and the glycerol can be compounded in any proportion.
Preferably, the solubilizing stabilizer is any one of or a mixture of at least two of PEG-60 hydrogenated castor oil, PEG-40 hydrogenated castor oil, Tween 20 or Tween 80.
According to the present invention, the pH adjusting agent is a pH adjusting agent that is conventional in the art, and any agent that can perform a pH adjusting function is possible, and is not particularly limited herein, and any one or a mixture of at least two of sodium bicarbonate, sodium citrate, or citric acid is used as the pH adjusting agent in the present invention.
Preferably, the sweetener is any one or a mixture of at least two of xylitol, saccharin sodium or aspartame.
Preferably, the cooling agent is any one or a mixture of at least two of menthol, peppermint oil or menthol lactate.
Preferably, the essence is any one of mint essence, wintergreen essence or green tea essence.
Preferably, the mouthwash comprises the following raw materials in percentage by mass:
wherein the sum of the content percentages of the components is 100 percent.
The sweetener is 0.5-20% by weight, for example, it may be 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, 25, and specific points between the above values, which are not intended to be exhaustive for the invention and for brevity.
The solvent is 5-50% by mass, for example, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 23%, 25%, 28%, 30%, 32%, 35%, 36%, 38%, 40%, 42%, 43%, 45%, 48%, 50%, and specific values therebetween, and for brevity and clarity, the present invention is not intended to be exhaustive of the specific values included in the ranges.
The humectant may be present in an amount of 8-40% by weight, such as 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 22%, 23%, 24%, 25%, 26%, 28%, 30%, 32%, 33%, 35%, 36%, 38%, 40%, and any particular values therebetween, and the invention is not intended to be exhaustive of the particular values included in the ranges for brevity and conciseness.
The mass percentage of the cooling agent is 0.01-1%, for example, 0.01%, 0.02%, 0.03%, 0.05%, 0.06%, 0.08%, 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1%, and specific values therebetween, are not limited to space and for the sake of brevity, and the invention is not intended to be exhaustive of the specific values included in the range.
The mass percentage of the solubilizing stabilizer is 0.3-5%, and for example, it may be 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1%, 1.2%, 1.5%, 1.8%, 2%, 2.2%, 2.3%, 2.5%, 2.8%, 3%, 3.2%, 3.5%, 3.6%, 3.8%, 4%, 4.2%, 4.5%, 4.6%, 4.8%, 5%, and specific values therebetween, which are not intended to be limiting to space and for brevity, and the invention is not intended to be exhaustive of the specific values included in the range.
The mass percentage of the pH adjuster is 0.3-10%, for example, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, or 10%, and the specific values between the above values are not exhaustive and for the sake of brevity.
The perfume may be 0.1-2% by mass, for example, 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1%, 1.2%, 1.3%, 1.4%, 1.5%, 1.6%, 1.7%, 1.8%, 1.9% or 2%, and the specific values between the above values are limited by space and for brevity, and the invention is not exhaustive of the specific values included in the range.
Preferably, the mouthwash comprises the following raw materials in percentage by mass:
wherein the sum of the content percentages of the components is 100 percent.
As the optimal technical scheme, the mouthwash comprises the following raw materials in percentage by mass:
in another aspect, the present invention provides a method for preparing the mouthwash according to the first aspect, comprising the following steps:
(1) adding sweetener and Aloe Barbadensis Miller extract into deionized water, stirring to dissolve, adding humectant, and stirring to obtain clear and transparent water solution;
(2) adding essence into solubilization stabilizer, mixing, adding propolis extract, and stirring to obtain dark brown oily solution;
(3) adding lipoic acid and a freshener into ethanol, and stirring until the lipoic acid and the freshener are uniformly dissolved to form a clear and transparent solution;
(4) adding the oily solution obtained in the step (2) into the solution obtained in the step (3), and uniformly stirring to form a transparent clear brown oily solution;
(5) and (3) slowly adding the oily solution obtained in the step (4) into the aqueous solution obtained in the step (1), stirring while adding until the mixture is uniform to form a clear and transparent solution, adjusting the pH value, standing overnight, and filtering and sterilizing to obtain a finished product.
Preferably, the pH adjustment in step (5) is the addition of a pH adjuster.
Preferably, the adjustment of the pH to a pH of 3 to 7, for example 3, 3.1, 3.2, 3.3, 3.5, 3.6, 3.7, 3.8, 3.9, 4, 4.2, 4.3, 4.5, 4.6, 4.8, 5, 5.2, 5.3, 5.5, 5.6, 5.8, 6, 6.2, 6.3, 6.5, 6.8, 7, preferably 4 to 6, and the specific values between the above values, are limited to space and for the sake of brevity, the invention is not exhaustive of the specific values included in the range.
In the invention, the prepared mouthwash is a yellow or brown transparent clear solution.
Compared with the prior art, the invention has at least the following beneficial effects:
(1) the lipoic acid, the propolis and the aloe extract of the mouthwash are mutually promoted, the lipoic acid, the propolis and the aloe extract of the mouthwash exert a synergistic effect, can effectively resist and inhibit bacteria in oral cavities, can effectively inhibit and remove dental plaque, can effectively treat oral cavities such as halitosis and oral ulcer to effectively relieve gingival bleeding, and can also have a relieving effect on diabetic mouth disease lesions;
(2) the mouthwash disclosed by the invention is safe and reliable, does not stimulate the skin, is long-acting in nourishing, can relieve the pain of the diabetic mouth-changing patient while inhibiting bacteria and deodorizing, has double effects, and can be used for a long time;
(3) the preparation method is simple, easy to operate and low in cost, is beneficial to industrial production, and lays a foundation for marketization.
Example 4
The mouthwash comprises the following raw materials in percentage by mass:
the preparation method is the same as example 1.
Comparative example 1
Same as example 1 except that there is no propolis extract, lipoic acid and aloe vera extract compared to example 1.
Comparative example 2
Compared with example 1, the method is the same as example 1 except that no propolis extract is added.
Comparative example 3
Compared to example 1, the same as example 1 except that lipoic acid is not present.
Comparative example 4
Compared to example 1, the same as example 1 except that there is no aloe vera extract.
Comparative example 5
The method is the same as example 1 except that the mass percent of the propolis extract is 15% compared with example 1.
Comparative example 6
The same procedure as in example 1 was repeated, except that the content of lipoic acid was 15% by mass as compared with example 1.
The working performance of examples 1 to 4 and comparative examples 1 to 6 was examined as follows:
(1) bacteriostasis:
strain: staphylococcus aureus, Escherichia coli, Bacillus dysenteriae, Pseudomonas aeruginosa, Streptococcus C, and Candida albicans;
the specific test method comprises the following steps: pouring culture medium of each test bacterium into a culture dish, sucking required test bacterium suspension into the culture dish by a liquid transfer gun after the culture medium is completely solidified, uniformly coating by a coating rod, dipping circular filter paper sheets into the mouthwash of the invention, uniformly placing the filter paper sheets on the culture medium coated with the bacterium suspension, sealing a seal film of the culture dish, horizontally inverting and culturing for a period of time, taking out and measuring the diameter of a bacteriostatic ring by a cross method, and evaluating the bactericidal activity according to the existence of the bacteriostatic ring and the size of the bacteriostatic ring.
The test results are shown in table 1:
TABLE 1
As can be seen from table 1, compared with comparative examples 1 to 6, examples 1 to 4 greatly improve the bacteriostatic effect by blending the mass fractions of the propolis extract, the lipoic acid and the aloe extract, and comparative example 4, examples 1 to 3 can further improve the bacteriostatic effect by further controlling the mass fraction of the propolis extract to 0.1 to 3%, the mass fraction of the lipoic acid to 0.1 to 3% and the mass fraction of the aloe extract to 0.5 to 10%; it is apparent from comparative examples 5 to 6 that the effects are remarkably inferior to those of examples 1 to 4 when the weight fractions of lipoic acid, propolis extract and aloe extract are out of the ranges.
(2) Clinical observations
360 people with diabetes and oral diseases in the age range of 30-70 years are selected as trial objects by adopting a civil survey grading method, the trial objects are randomly and equally divided into 12 groups, and the mouthwash prepared by the embodiment and the comparative example is used for 2 times a day and is used for four months.
And (4) counting the test results:
the using effects of the ingredients are divided into 5 points: 5 is the highest score, which means very good and very effective; 4, the method has good and obvious effect; 3, the classification is acceptable and has effect; no effect was observed for a score of 3 or less, which was not acceptable. The average score of each item is as follows.
The results are shown in table 2 below:
TABLE 2
As can be seen from table 2, compared to comparative examples 1 to 6, examples 1 to 4 greatly improve the effect of relieving diabetic mouth disease by formulating the mass fractions of the propolis extract, lipoic acid and aloe extract, and comparative example 4, examples 1 to 3 can further improve the relieving effect by further controlling the mass fraction of the propolis extract to 0.1 to 3%, the mass fraction of the lipoic acid to 0.1 to 3% and the mass fraction of the aloe extract to 0.5 to 10%; it is apparent from comparative examples 5 to 6 that the effects are remarkably inferior to those of examples 1 to 5 when the weight fractions of lipoic acid, propolis extract and aloe extract are out of the ranges.
Secure data
The anti-inflammatory and bacteriostatic preparation has good anti-inflammatory and bacteriostatic effects, but the safety needs to be paid attention to in the application process, so the following safety test is carried out.
1. Multiple (acute) skin irritation test
Multiple (acute) skin irritation tests were performed according to technical specifications for cosmetic safety (2015 edition), and the results demonstrated that: the thioctic acid 20% and propolis extract 20% or less are safe and non-irritant.
2. Mucosal irritation test
The mouth wash of the invention is used for carrying out stimulation tests on oral mucosa and gingival mucosa of rabbits and puppies, and the results prove that: the mouthwash of the invention has no irritation to mucosa and no pathological damage.
Experiments prove that the anti-inflammation and bacteriostatic preparation is an article which is harmless, non-toxic, free of side effects and free of stimulation and has a large safety factor.
The above embodiments show that the propolis composition is reasonably prepared by using the proper propolis extract, the lipoic acid and the aloe extract, and the proportion of the three components is adjusted, so that the propolis extract, the lipoic acid and the aloe extract have a synergistic effect, can relieve the pain of patients with diabetes mouth diseases, has double effects, is safe and non-irritant, and can be used for a long time.
The applicant states that the present invention is illustrated by the above examples to show the detailed process equipment and process flow of the present invention, but the present invention is not limited to the above detailed process equipment and process flow, i.e. it does not mean that the present invention must rely on the above detailed process equipment and process flow to be implemented. It should be understood by those skilled in the art that any modification of the present invention, equivalent substitutions of the raw materials of the product of the present invention, addition of auxiliary components, selection of specific modes, etc., are within the scope and disclosure of the present invention.