CN111686146A - Antibacterial, anti-inflammatory and antipruritic composition and preparation method thereof - Google Patents
Antibacterial, anti-inflammatory and antipruritic composition and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a bacteriostatic, anti-inflammatory and antipruritic composition, which contains N-acetylneuraminic acid and a honeysuckle extract, has good repairing, anti-inflammatory and anti-allergy effects, can effectively relieve skin itch caused by mosquito bites, and can quickly eliminate the phenomena of skin redness and swelling caused by mosquito bites and the like. The composition is a homogeneous liquid preparation, has good stability, no essence, no pungent smell, high consumer acceptance, convenient use, cool and comfortable use feeling, no pollution to clothes, safe components, suitability for all people, simple preparation process and contribution to quantitative production.
Description
Technical Field
The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to a bacteriostatic, anti-inflammatory and antipruritic composition and a preparation method thereof.
Background
Along with the warming-up of the climate, a large number of mosquitoes breed, and the probability that people are bitten by the mosquitoes is obviously increased. When mosquitoes bite the human body, saliva in the salivary glands of the mosquitoes can be injected into the skin of the human body. The saliva of the mosquito contains a plurality of anticoagulant chemical substances, so that petechia ecchymosis appears on the skin of the bitten human body; meanwhile, saliva of mosquitoes contains allergy-related proteins such as salivary allergens, natural antigen proteins and adenosine deaminase, and the substances cause local or systemic allergic reactions after a human body is bitten. This dermatitis caused by mosquito bites is called insect dermatitis and is a common condition in dermatology.
Insect dermatitis is usually characterized in that pimples, wheal, edematous erythema, blisters, herpes dunghii, ecchymosis and the like appear at the local part of a bite, the center of a skin lesion can see the bite trace, and the skin lesion has stabbing pain, burning pain and extreme itching with different degrees, wherein the most common skin pruritus is used, the pruritus is caused by anaphylactic reaction at the bite part of a person due to mosquito bite, and the pruritus can cause physiological and psychological unpleasant feelings, thereby bringing troubles to the life of people.
The common external preparation for local itching relieving of the skin contains various chemical components, the defects of large smell, inconvenience in smearing and unsatisfactory itching relieving effect exist generally, and the smell of part of products can also cause unpleasant feeling.
Disclosure of Invention
Based on the above, in order to solve the disadvantages and shortcomings of the prior art, the invention aims to provide a bacteriostatic, anti-inflammatory and antipruritic composition and a preparation method thereof. The composition contains N-acetylneuraminic acid and honeysuckle extract, has good antibacterial, anti-inflammatory and itching relieving effects, has no pungent smell, and is high in user acceptance degree.
In order to realize the purpose, the technical scheme adopted by the invention is as follows:
the antibacterial, anti-inflammatory and antipruritic composition comprises the following components in parts by weight: 0.01-10 parts of N-acetylneuraminic acid and 0.01-10 parts of honeysuckle extract.
Preferably, the antibacterial, anti-inflammatory and antipruritic composition comprises the following components in parts by weight: 4-6 parts of N-acetylneuraminic acid and 4-6 parts of honeysuckle extract.
Most preferably, the bacteriostatic anti-inflammatory and antipruritic composition comprises the following components in parts by weight: 5 parts of N-acetylneuraminic acid and 5 parts of honeysuckle extract.
N-acetylneuraminic acid is an important component of cell membrane protein and is involved in various physiological functions on the cell surface. N-acetylneuraminic acid has the functions of improving intelligence and memory, resisting senile dementia, improving the absorption of vitamins and minerals by intestinal tracts, resisting bacteria and viruses, improving immunity and the like.
The honeysuckle extract mainly contains chlorogenic acid, the chlorogenic acid has complex and various antibacterial mechanisms, has broad-spectrum antibacterial effect, and has certain inhibition effect on gram-negative bacteria, gram-positive bacteria, mold and partial viruses.
According to experimental research, the N-acetylneuraminic acid and the honeysuckle extract have good antibacterial, anti-inflammatory and antipruritic effects when used in combination in the above dosage.
Preferably, the antibacterial, anti-inflammatory and antipruritic composition also comprises the following components in parts by weight: 0.01-1 part of glyceryl caprylate, 0.01-1 part of caprylyl hydroximic acid, 0.01-1 part of p-hydroxyacetophenone, 0.1-10 parts of ethanol, 0.1-2 parts of dipotassium glycyrrhizinate and 0.01-0.05 part of EDTA disodium.
Preferably, the formulation of the antibacterial, anti-inflammatory and antipruritic composition is liquid, ointment, cream or gel; more preferably a liquid agent.
Preferably, every 100 parts by weight of the antibacterial, anti-inflammatory and antipruritic composition is composed of the following components in parts by weight: 0.01-10 parts of N-acetylneuraminic acid, 0.01-10 parts of honeysuckle extract, 0.01-1 part of glyceryl caprylate, 0.01-1 part of caprylyl hydroximic acid, 0.01-1 part of p-hydroxyacetophenone, 0.1-10 parts of ethanol, 0.1-2 parts of dipotassium glycyrrhizinate, 0.01-0.05 part of EDTA disodium and the balance of water.
Most preferably, every 100 parts by weight of the antibacterial anti-inflammatory and antipruritic composition is composed of the following components in parts by weight: 5 parts of N-acetylneuraminic acid, 5 parts of honeysuckle extract, 0.5 part of caprylic glyceride, 0.5 part of caprylyl hydroxamic acid, 0.5 part of p-hydroxyacetophenone, 5 parts of ethanol, 1 part of dipotassium glycyrrhizinate, 0.02 part of EDTA disodium and the balance of water.
Preferably, the preparation method of the antibacterial anti-inflammatory and antipruritic composition comprises the following steps:
(1) mixing glyceryl caprylate, caprylyl hydroximic acid, p-hydroxyacetophenone and ethanol, and adding appropriate amount of water to dissolve;
(2) heating the rest water to 80-90 ℃, keeping the temperature constant for 20-40 min, and then adding dipotassium glycyrrhizinate and EDTA disodium for dissolving;
(3) and (3) cooling the solution obtained in the step (2) to 40-45 ℃, then adding the solution obtained in the step (1), uniformly stirring, then adding N-acetylneuraminic acid and the honeysuckle extract, uniformly stirring, and filtering by using a sterile sterilization membrane to obtain the antibacterial, anti-inflammatory and antipruritic composition.
In the step (2), the heated water at the temperature of 80-90 ℃ is subjected to constant temperature treatment, so that the sterilization effect can be achieved.
Preferably, in the step (3), the cooling rate is 0.2-0.6 ℃/min. Cooling at this rate ensures that the dissolved component system is more stable as a homogeneous phase, without agglomeration.
Compared with the prior art, the invention has the beneficial effects that: 1. the composition contains N-acetylneuraminic acid and honeysuckle extracts, has good repairing, anti-inflammation and anti-allergy effects, can effectively relieve skin itch caused by mosquito bites, and can quickly eliminate skin red swelling and the like caused by mosquito bites. 2. The composition is a homogeneous liquid preparation, has good stability, no essence, no pungent smell, high consumer acceptance, convenient use, cool and comfortable use feeling, no pollution to clothes, safe components, suitability for all people, simple preparation process and contribution to quantitative production.
Detailed Description
To better illustrate the objects, aspects and advantages of the present invention, the present invention is further illustrated by the following examples. It is apparent that the following examples are only a part of the embodiments of the present invention, and not all of them. It should be understood that the embodiments of the present invention are only for illustrating the technical effects of the present invention, and are not intended to limit the scope of the present invention. The starting materials used in the examples of the present invention are all commercially available unless otherwise specified.
The chlorogenic acid content of the honeysuckle extract used in the examples is more than or equal to 5%; the sterile sterilization membrane is a Millipore filter membrane with the model of 0.22 um; ethanol was purchased from Shanghai Tantake Technique, Inc. and had a purity of not less than 99.7%.
Examples 1 to 7
Examples 1 to 7 provide bacteriostatic, anti-inflammatory and antipruritic compositions, the formulation composition of which is shown in table 1.
The preparation method of the antibacterial, anti-inflammatory and antipruritic composition of the embodiment 1-7 comprises the following steps:
(1) mixing glyceryl caprylate, caprylyl hydroximic acid, p-hydroxyacetophenone and ethanol, and adding appropriate amount of water to dissolve;
(2) heating the rest water to 85 ℃, keeping the temperature for 30min (or keeping the temperature at 80-90 ℃ for 20-40 min), adding dipotassium glycyrrhizinate and EDTA disodium, and dissolving;
(3) and (3) cooling the solution obtained in the step (2) to 45 ℃ (40-45 ℃) at the speed of 0.6 ℃/min (0.2-0.6 ℃/min), then adding the solution obtained in the step (1), stirring uniformly, then adding N-acetylneuraminic acid and the honeysuckle extract, stirring uniformly, and filtering by using a sterile aseptic membrane to obtain the antibacterial, anti-inflammatory and itching-relieving composition.
TABLE 1 formulation composition of bacteriostatic, anti-inflammatory and antipruritic compositions
Comparative examples 1 to 3
The compositions of comparative examples 1 to 3 were prepared in the same manner as in the examples, as shown in Table 2.
TABLE 2 formulation composition of the compositions
| Components | Comparative example 1 | Comparative example 2 | Comparative example 3 |
| N-acetylneuraminic acid | 10g | 0g | 0g |
| Honeysuckle extract | 0g | 10g | 10g |
| Glycerol caprylate | 0.5g | 0.5g | 0g |
| Octanoyl hydroximic acid | 0.5g | 0.5g | 0g |
| P-hydroxyacetophenone | 0.5g | 0.5g | 1.5g |
| Ethanol | 5g | 5g | 5g |
| Glycyrrhizic acid dipotassium salt | 1g | 1g | 1g |
| EDTA disodium salt | 0.02g | 0.02g | 0.02g |
| Water (W) | To 100g | To 100g | To 100g |
Test for anti-inflammatory Effect
A sample to be tested: the compositions prepared in examples 1-7 and comparative examples 1-3.
Positive control: hydrocortisone butyrate cream 13101304, 20g:20mg, produced by Tianjin Jinyao pharmaceutical Co.
Negative control: and (5) purifying the water.
Experimental animals: the test mice are Kunming, SPF grade and male; weight: 22-25 g.
Feeding conditions are as follows: the test animals were kept in cages, and 6 animals of the same sex were kept in each cage. The feed is SPF level experimental grain rat food. The drinking water is sterilized purified water. The padding at the bottom of the cage is poplar wood chips which are sterilized before use and are replaced every two days. The laboratory temperature is 20-22 ℃, the humidity is 55% -60%, and the light and dark period is 12 hours.
The test method comprises the following steps: 144 mice of the above specification were prepared and randomly divided into 12 groups: a positive control group using a positive control, a negative control group using a negative control, examples 1 to 7 using the compositions of examples 1 to 7, respectively, and comparative examples 1 to 3 using the compositions of comparative examples 1 to 3, respectively. The right ear of each mouse group was smeared with the test substance of the corresponding group twice a day for six consecutive days. On the seventh day, after 1 hour of administration, the groups were washed out with distilled water, wiped clean with dry cotton balls, the right ear was coated with 0.2 mL/xylene, the left ear was used as a control, the animals were sacrificed after 2 hours, the same area of the ears was cut off with a punch having a diameter of 8mm, and the difference between the weights of the right and left ears was measured as swelling degree. The swelling degree of each group was calculated and statistically processed by the LSD test of the one-way anova function of the SPSS15.0 software (overall sample data is homogeneity of variance), the results are shown in table 3.
TABLE 3 Effect of test samples on swelling of mouse auricles by Paralyne
| Group of | Dosage form | Animal number (only) | Swelling degree of auricle (g) |
| Example 1 | 1mL | 12 | 0.0035±0.0013** |
| Example 2 | 1mL | 12 | 0.0041±0.0014** |
| Example 3 | 1mL | 12 | 0.0042±0.0022** |
| Example 4 | 1mL | 12 | 0.0055±0.0016** |
| Example 5 | 1mL | 12 | 0.0052±0.0023** |
| Example 6 | 1mL | 12 | 0.0070±0.0034** |
| Example 7 | 1mL | 12 | 0.0061±0.0022** |
| Comparative example 1 | 1mL | 12 | 0.0075±0.0015** |
| Comparative example 2 | 1mL | 12 | 0.0078±0.0014** |
| Comparative example 3 | 1mL | 12 | 0.0082±0.0012** |
| Positive control group | / | 12 | 0.0048±0.0008** |
| Negative control group | / | 12 | 0.0085±0.0023 |
Note: as compared to negative control group, indicates p <0.01
The results in table 3 show that the swelling degree of the auricle of the test sample and the positive control group is significantly different (p is less than 0.01) compared with the swelling degree of the auricle of the negative control group, and the statistical significance is achieved.
The swelling degree of auricles of the mice in the groups of examples 1-7 is obviously lower than that of the mice in the groups of comparative examples 1-3, and the composition has better anti-inflammatory effect when containing N-acetylneuraminic acid and honeysuckle extract; the swelling degree of the auricle of the mice in the group of the comparative example 3 is also obviously higher than that of the mice in the group of the comparative example 2, which shows that in addition to the influence of the N-acetylneuraminic acid and the honeysuckle extract on the anti-inflammatory effect of the composition, other components in the composition influence the anti-inflammatory effect, and the composition containing the components used in the formula has better anti-inflammatory effect.
The compositions of example 1, example 2 and example 3 differ only in the ratio of N-acetylneuraminic acid to the honeysuckle extract, whereas the swelling degree of the auricles of the mice of example 1 is significantly lower than that of the mice of example 2 and example 3, as can be seen from the data in table 3; the composition has the best anti-inflammatory effect when the mass ratio of the N-acetylneuraminic acid to the honeysuckle extract is 1: 1.
The compositions of example 1, example 4 and example 5 differ only in the content of N-acetylneuraminic acid and honeysuckle extract in the composition, while it can be seen from the data in table 3 that the swelling degree of the auricles of the mice of example 1 group is significantly lower than that of the mice of example 4 group and the mice of example 5 group; it is shown that, as the content of N-acetylneuraminic acid and the content of honeysuckle extract are increased, the anti-inflammatory effect of the composition is also enhanced, and when the content of N-acetylneuraminic acid and the content of honeysuckle extract are respectively increased to 5 parts by weight, the anti-inflammatory effect of the composition is optimal, and the content is continuously increased, which in turn causes the anti-inflammatory effect of the composition to be reduced. Therefore, when the content of N-acetylneuraminic acid and the content of the honeysuckle extract in the composition are respectively 5 parts by weight, the anti-inflammatory effect of the composition is best.
The mice of example 6 and example 7 had significantly higher degrees of swelling of the pinna than the mice of example 1, indicating that the anti-inflammatory effect of the composition was best when prepared with the formulation of example 1.
Test of bacteriostatic Effect
A sample to be tested: the compositions prepared in examples 1-7 and comparative examples 1-3.
The test method comprises the following steps: plate counting method
(1) And (3) adding 3mL of staphylococcus aureus liquid into 11 sterile test tubes respectively.
(2) 1mL of physiological saline was added to 1 tube as a control bacterial suspension, and 1mL of the test sample (i.e., the compositions prepared in examples 1 to 7 and comparative examples 1 to 3) was added to the remaining 10 tubes as experimental bacterial suspensions, and the test suspensions were mixed uniformly.
(3) 11 test tubes were placed in a 37 ℃ constant temperature shaking table for 2 h.
(4) Using a gradient dilution method, using sterile water to perform gradient dilution on the bacterial suspension, wherein the dilution is performed by 5 gradients which are respectively 10-1、10-2、10-3、10-4、10-5And (4) diluting the solution.
(5) 1mL of each dilution was pipetted into the corresponding number of dishes, and about 20mL of beef extract peptone medium (45 ℃) was poured into the corresponding number of dishes and mixed immediately.
(6) After solidification, the mixture is inverted and cultured in an incubator at 37 ℃ for 48 hours.
(7) Counting the colonies in the culture dish, selecting the colonies with the number of 30-300 CFU/dish to calculate the colonies of the experimental group and the control group. And calculating the bacteriostasis rate by taking the experimental group as a numerator and taking the control group as a denominator. Each set of experiments was repeated three times. The results are shown in Table 4.
TABLE 4 bacteriostasis rates
| Test article | The antibacterial rate is% |
| Example 1 | 85 |
| Example 2 | 80 |
| Example 3 | 79 |
| Example 4 | 72 |
| Example 5 | 74 |
| Example 6 | 60 |
| Example 7 | 71 |
| Comparative example 1 | 50 |
| Comparative example 2 | 53 |
| Comparative example 3 | 48 |
As can be seen from the results in table 4: the bacteriostatic rate of the composition of examples 1-7 is obviously higher than that of the composition of comparative examples 1-3, which shows that the composition has better bacteriostatic effect when containing N-acetylneuraminic acid and honeysuckle extract at the same time; the bacteriostatic rate of the composition of comparative example 3 was lower than that of the composition of comparative example 2, which indicates that, in addition to N-acetylneuraminic acid and the honeysuckle extract affecting the bacteriostatic effect of the composition, other components in the composition also affect the bacteriostatic effect, and the composition containing the components used in the formula of the present invention has a better bacteriostatic effect.
The compositions of example 1, example 2 and example 3 are different only in the proportion of N-acetylneuraminic acid and honeysuckle extract, and the bacteriostatic rate of the composition of example 1 is obviously higher than that of the compositions of example 2 and example 3; the antibacterial effect of the composition is best when the mass ratio of the N-acetylneuraminic acid to the honeysuckle extract is 1: 1.
The compositions of example 1, example 4 and example 5 are different only in the content of N-acetylneuraminic acid and honeysuckle extract in the composition, while the bacteriostatic rate of the composition of example 1 is significantly higher than that of the compositions of example 4 and example 5; the antibacterial effect of the composition is enhanced along with the increase of the content of the N-acetylneuraminic acid and the content of the honeysuckle extract, and when the content of the N-acetylneuraminic acid and the content of the honeysuckle extract are respectively increased to 5 parts by weight, the antibacterial effect of the composition is optimal, the content is continuously increased, and the antibacterial effect of the composition is reduced. Therefore, when the content of the N-acetylneuraminic acid and the content of the honeysuckle extract in the composition are respectively 5 parts by weight, the bacteriostatic effect of the composition is best.
The bacteriostatic ratio of the compositions of examples 4 and 5 was significantly lower than that of the composition of example 1, indicating that the bacteriostatic effect of the compositions was the best when prepared with the formulation of example 1.
Test for antipruritic Effect
A sample to be tested: the compositions prepared in examples 1-7 and comparative examples 1-3.
The trial method comprises the following steps: 20 volunteers aged 12-50, respectively trying the above samples, spraying the samples on the mosquito bite parts, and recording the samples reaching itching relieving effect within 1 minute. The statistical results are shown in table 5.
TABLE 5 antipruritic effects
| Test article | Trial number (human) | The number of people who can achieve the effect of relieving itching within 1 minute(human) |
| Example 1 | 20 | 18 |
| Example 2 | 20 | 13 |
| Example 3 | 20 | 14 |
| Example 4 | 20 | 10 |
| Example 5 | 20 | 10 |
| Example 6 | 20 | 7 |
| Example 7 | 20 | 9 |
| Comparative example 1 | 20 | 1 |
| Comparative example 2 | 20 | 2 |
| Comparative example 3 | 20 | 1 |
The trial results in table 5 show that the composition of the present invention has a good antipruritic effect on pruritus caused by mosquito bite, and is quick in effect, wherein the composition of examples 1 to 3 has a good antipruritic effect, and the composition of example 1 has a best antipruritic effect.
In conclusion, the composition provided by the invention has good anti-inflammatory, antibacterial and antipruritic effects and is quick in effect. The composition is cool and comfortable to use, does not pollute clothes, has no stimulation to skin, is convenient to use, and has no pungent smell after being fed back by volunteers.
Finally, it should be noted that the above embodiments are only used for illustrating the technical solutions of the present invention and not for limiting the protection scope of the present invention, and although the present invention is described in detail with reference to the preferred embodiments, it should be understood by those skilled in the art that modifications or equivalent substitutions can be made on the technical solutions of the present invention without departing from the spirit and scope of the technical solutions of the present invention.
Claims (9)
1. The antibacterial, anti-inflammatory and antipruritic composition is characterized by comprising the following components in parts by weight: 0.01-10 parts of N-acetylneuraminic acid and 0.01-10 parts of honeysuckle extract.
2. The bacteriostatic, anti-inflammatory and antipruritic composition according to claim 1, which comprises the following components in parts by weight: 4-6 parts of N-acetylneuraminic acid and 4-6 parts of honeysuckle extract.
3. The bacteriostatic, anti-inflammatory and antipruritic composition according to claim 1, which comprises the following components in parts by weight: 5 parts of N-acetylneuraminic acid and 5 parts of honeysuckle extract.
4. The bacteriostatic, anti-inflammatory and antipruritic composition according to claim 1, further comprising the following components in parts by weight: 0.01-1 part of glyceryl caprylate, 0.01-1 part of caprylyl hydroximic acid, 0.01-1 part of p-hydroxyacetophenone, 0.1-10 parts of ethanol, 0.1-2 parts of dipotassium glycyrrhizinate and 0.01-0.05 part of EDTA disodium.
5. The bacteriostatic, anti-inflammatory and antipruritic composition according to any one of claims 1 to 4, wherein the composition is in the form of liquid, ointment, cream or gel.
6. The antibacterial, anti-inflammatory and antipruritic composition is characterized in that each 100 parts by weight of the composition comprises the following components in parts by weight: 0.01-10 parts of N-acetylneuraminic acid, 0.01-10 parts of honeysuckle extract, 0.01-1 part of glyceryl caprylate, 0.01-1 part of caprylyl hydroximic acid, 0.01-1 part of p-hydroxyacetophenone, 0.1-10 parts of ethanol, 0.1-2 parts of dipotassium glycyrrhizinate, 0.01-0.05 part of EDTA disodium and the balance of water.
7. The bacteriostatic, anti-inflammatory and antipruritic composition according to claim 6, wherein each 100 parts by weight of the composition comprises the following components in parts by weight: 5 parts of N-acetylneuraminic acid, 5 parts of honeysuckle extract, 0.5 part of caprylic glyceride, 0.5 part of caprylyl hydroxamic acid, 0.5 part of p-hydroxyacetophenone, 5 parts of ethanol, 1 part of dipotassium glycyrrhizinate, 0.02 part of EDTA disodium and the balance of water.
8. The method for preparing the bacteriostatic, anti-inflammatory and antipruritic composition according to claim 6 or 7, which comprises the following steps:
(1) mixing glyceryl caprylate, caprylyl hydroximic acid, p-hydroxyacetophenone and ethanol, and adding appropriate amount of water to dissolve;
(2) heating the rest water to 80-90 ℃, keeping the temperature constant for 20-40 min, and then adding dipotassium glycyrrhizinate and EDTA disodium for dissolving;
(3) and (3) cooling the solution obtained in the step (2) to 40-45 ℃, then adding the solution obtained in the step (1), uniformly stirring, then adding N-acetylneuraminic acid and the honeysuckle extract, uniformly stirring, and filtering by using a sterile sterilization membrane to obtain the antibacterial, anti-inflammatory and antipruritic composition.
9. The method for preparing the bacteriostatic, anti-inflammatory and antipruritic composition according to claim 8, wherein in the step (3), the cooling rate is 0.2-0.6 ℃/min.
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