CN115025209A - Lysozyme-containing personal care gel - Google Patents

Lysozyme-containing personal care gel Download PDF

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CN115025209A
CN115025209A CN202210666847.8A CN202210666847A CN115025209A CN 115025209 A CN115025209 A CN 115025209A CN 202210666847 A CN202210666847 A CN 202210666847A CN 115025209 A CN115025209 A CN 115025209A
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personal care
gel
lysozyme
oxymatrine
care gel
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潘宏涛
潘先莲
卢亚萍
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Zhejiang Qingkang Biotechnology Co ltd
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Zhejiang Qingkang Biotechnology Co ltd
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    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
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    • A61K9/0034—Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
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Abstract

The invention relates to a personal care gel preparation, wherein the weight ratio of active ingredients of lysozyme, subprostrate sophora and oxymatrine is 1: (1-5): (1-5). The personal care gel preparation has simple preparation method and stable quality, and the three active ingredients can exert respective effects and can also synergistically treat gynecological diseases such as vaginitis and the like caused by various bacteria and fungi. In addition, the lysozyme, the subprostrate sophora and the oxymatrine are natural in source and have no toxic or side effect.

Description

Lysozyme-containing personal care gel
Technical Field
The invention relates to the field of medicines, and in particular relates to a personal care gel containing lysozyme.
Background
Vaginitis is a group of disorders that cause vulvovaginal symptoms such as itching, burning, irritation and abnormal fluid discharge, and is believed by western medicine theory to be caused by dysbacteriosis in women. The western medicine treatment mode is mainly to adopt oral or external antibacterial drugs to inhibit pathogenic microorganisms, for example, nitroimidazole antibacterial drugs are commonly used for trichomonas vaginitis, clindamycin antibacterial drugs are commonly used for bacterial vaginitis besides the nitroimidazole antibacterial drugs, and azole and polyene antibacterial drugs are commonly used for candida vaginitis. However, the excessive application of the western antibacterial drugs is easy to cause pathogenic microorganisms to generate drug resistance, so that the disease condition is repeated.
Vaginitis belongs to leukorrheal diseases in the traditional Chinese medicine category, and the traditional Chinese medicine considers that the cause of the leukorrheal diseases is damp evil and the root cause is dysfunction of spleen and kidney. The traditional Chinese medicine adopts a method of treatment based on syndrome differentiation to regulate the spleen and eliminate dampness and warm the kidney to arrest astringency, so that the vaginitis is fundamentally treated, and the disease condition is not easy to repeat. The existing research proves that the traditional Chinese medicine external treatment has higher effective rate and less adverse reaction than the western medicine treatment.
The external preparation is a medicinal preparation directly applied to skin and mucous membrane, can exert local treatment effect, can enter systemic circulation through skin or mucous membrane absorption to achieve the purpose of systemic treatment, and can reduce irritation and adverse reaction of the medicament to gastrointestinal tract, avoid first pass effect of liver and improve bioavailability of the medicament. With the development of modern science and technology, the application of novel external preparations (such as transdermal preparations and transmucosal preparations) in medical, gynecological, pediatric and other diseases is becoming widespread. In recent years, the market of gynecological traditional Chinese medicine external application has the leading dosage forms of lotion and suppository, and the gynecological traditional Chinese medicine external application new preparation has film and gel.
Gels are semisolid preparations having gelling properties made of a drug and a suitable matrix, and are generally classified into water-soluble gels and organic gels (or oil-soluble gels) according to the gel matrix. The drug in the water-soluble gel can be dissolved in the water-dispersible solvent; the drug in the organogel should be soluble in the oil dispersion solvent. According to different preparation methods, the gel can be divided into environment-sensitive gel, liposome gel, micro-emulsion gel and the like, and the environment-sensitive gel such as temperature-sensitive gel, magnetic-responsive polymer gel microspheres, pH-sensitive gel and the like is prepared by utilizing different sensitivity degrees of the gel to physical environments such as temperature, magnetic field, pH and the like; mixing gel matrix with phospholipid and cholesterol to obtain liposome gel with slow release effect; the microemulsion gel capable of improving the solubility of the insoluble drug is prepared by mixing the drug with a proper water phase, an oil phase and an emulsifier according to a certain proportion. The adhesiveness of the gel can make the medicine act on the affected part for a long time, and better promote the absorption of the effective components and exert the medicine effect. In addition, the gel can be more convenient for patients to take medicine and improve the compliance of the medicine taking.
Lysozyme, also known as muramidase or N-acetylmuramyl glycan hydrolase, is an alkaline enzyme that hydrolyzes mucopolysaccharides in pathogenic bacteria. The bacterial lysis is achieved by breaking the beta-1, 4 glycosidic bond between N-acetylmuramic acid and N-acetylglucosamine in the cell wall, breaking down the cell wall insoluble mucopolysaccharide into soluble glycopeptides, causing the contents of the broken cell wall to escape.
The radix Sophorae Tonkinensis is dried root and rhizome of Sophora tonkinensis Gagnep of Leguminosae, also called radix Sophorae Tonkinensis, and is mainly distributed in Guangxi and Guizhou provinces, and has effects of clearing heat and detoxicating, and relieving swelling and sore throat. Modern pharmacological research shows that the subprostrate sophora has the pharmacological effects of resisting tumor, virus, pain, inflammation, liver injury, oxidation, immunity and the like. The radix Sophorae Tonkinensis contains alkaloids, flavonoids, and triterpenes, and its main active ingredients include matrine, oxymatrine, cytisine, sophocarpine, sophorol, formononetin, vietnamese sophorol, radix Sophorae Tonkinensis extract, Korean sophoricoside, and trifoliol pterocarpus santalin.
The oxymatrine is the most main alkaloid component in the radix sophorae flavescentis, and has obvious anti-inflammatory, analgesic and anti-tumor effects. The in vivo anti-inflammatory effect results prove that each dose group of oxymatrine can reduce the swelling degree of the ears of mice, reduce the times of acetic acid torsion of the mice under test and relieve the swelling degree of the feet of the rats. The oxymatrine is injected into the abdominal cavity of a BALB/C mouse, and the result shows that the oxymatrine can reduce the proportion of Tfh cells of the BALB/C mouse, inhibit the transcription of Tfh cell Bcl-6mRNA, reduce the secretion level of IL-21 of the mouse and have obvious effect of regulating the immune function of the Tfh cells. The oxymatrine is acted on mice with immunological liver injury caused by ConA, and the result shows that a oxymatrine high-dose group can obviously reduce ALT activity, inhibit AST, TBIL, CD4+ IL-17A expression and up-regulate the proportion of CD4+ CD25+ FoxP3+ Treg, and the oxymatrine has a better protection effect on the mice with immunological liver injury induced by ConA.
At present, the application of lysozyme, sophocarpidine and oxymatrine in the field of personal care gel has not been reported.
Disclosure of Invention
The invention aims to solve the technical problem of providing a personal care gel preparation which can effectively inhibit bacteria and has natural active ingredient sources.
The technical scheme adopted by the invention for solving the problems is to provide a personal care gel preparation, wherein the weight ratio of active ingredients of lysozyme, subprostrate sophora and oxymatrine is 1: (1-5): (1-5).
Preferably, in the personal care gel preparation, the weight ratio of lysozyme, subprostrate sophora and oxymatrine is 1: (1-3): (1-3).
More preferably, in the personal care gel preparation, the weight ratio of lysozyme, subprostrate sophora and oxymatrine is 1:1: 2.
preferably, the lysozyme is extracted from egg white.
Preferably, the personal care gel preparation further comprises pharmaceutically acceptable auxiliary materials.
More preferably, the pharmaceutically acceptable adjuvant is selected from one or more of a gel base, a humectant, a solubilizer and a solvent.
Further preferably, the pharmaceutically acceptable auxiliary materials comprise a gel matrix, a humectant, a solubilizer and a solvent.
Preferably, the gel matrix is selected from one or more of sodium carboxymethylcellulose, carbomer, poloxamer and hydroxypropyl methylcellulose; more preferably, the gel matrix is a composition of sodium carboxymethyl cellulose and poloxamer; further preferably, the gel matrix is a composition of sodium carboxymethyl cellulose and poloxamer 188, and the weight ratio of the sodium carboxymethyl cellulose to the poloxamer 188 is (1-10): 1; most preferably, the gel matrix is a combination of sodium carboxymethylcellulose and poloxamer 188 in a weight ratio of 8: 1.
Preferably, the humectant is glycerin or propylene glycol; more preferably, the humectant is glycerin.
Preferably, the solubilizer is tween 80 or tween 60; more preferably, the solubilizer is tween 80.
Preferably, the solvent is distilled water.
More preferably, the pharmaceutically acceptable auxiliary materials are sodium carboxymethylcellulose, poloxamer 188, glycerol, tween 80 and distilled water.
Further preferably, the personal care gel preparation is prepared from the following components in percentage by weight: 0.25% lysozyme, 0.25% subprostrate sophora, 0.5% oxymatrine, 8% sodium carboxymethylcellulose, 1% poloxamer 188, 15% glycerol, 5% tween 80 and 70% distilled water.
The second aspect of the present invention provides a method for preparing the personal care gel preparation, which comprises the following steps:
(1) mixing lysozyme, subprostrate sophora and oxymatrine with solubilizer uniformly to obtain medicinal liquid;
(2) adding a humectant into the gel matrix, uniformly mixing, and uniformly mixing with the liquid medicine prepared in the step (1);
(3) and (3) adding a solvent into the solution obtained in the step (2), stirring for swelling, and standing for 24 hours to obtain the nano-composite material.
The third aspect of the invention also provides the use of the personal care gel formulation described above in the manufacture of a medicament for inhibiting bacteria and/or fungi.
Preferably, the bacteria and/or fungi are staphylococcus aureus and/or candida albicans.
More preferably, the invention also provides the application of the private gel preparation in preparing a medicament for simultaneously inhibiting staphylococcus aureus and candida albicans.
The fourth aspect of the invention also provides an application of the gel matrix composition in improving the chemical stability of the personal care gel preparation, wherein the gel matrix composition comprises sodium carboxymethyl cellulose and poloxamer 188, and the weight ratio of the sodium carboxymethyl cellulose to the poloxamer 188 is (1-10): 1.
preferably, the weight ratio of the sodium carboxymethylcellulose to the poloxamer 188 is 8: 1.
preferably, the improvement of the chemical stability of the personal care gel preparation refers to the reduction of the generation amount of the subprostrata sophora and/or oxymatrine impurities in the preparation.
More preferably, the improvement of the chemical stability of the personal care gel preparation refers to the reduction of the generation amount of the subprostrata sophora root extract and oxymatrine impurity in the preparation at the same time.
The invention has the positive and beneficial effects that:
surprisingly, it has been found through repeated experiments that the combination of lysozyme with sophoricine and oxymatrine has a synergistic effect on inhibiting the generation of bacteria and/or fungi. The personal care gel preparation has simple preparation method and stable quality, and the three active ingredients can exert respective effects and can also synergistically treat gynecological diseases such as vaginitis and the like caused by various bacteria and fungi. In addition, the lysozyme, the subprostrate sophora and the oxymatrine are natural in source and have no toxic or side effect.
Detailed Description
The present invention will be further described with reference to the following examples, but the embodiments of the present invention are not limited thereto. The experimental procedures used in the following examples are all conventional procedures unless otherwise specified. The lysozyme used in examples and experimental examples was lysozyme extracted from egg white.
Example 1 personal Care gel formulation G1 containing Lysozyme
Mixing 0.25g lysozyme, 0.25g subprostrate sophora and 0.5g oxymatrine with 5g tween 80 to obtain medicinal liquid; adding 15g of glycerol into a mixture of 8g of sodium carboxymethylcellulose and 1g of poloxamer 188, uniformly mixing, and uniformly mixing with the liquid medicine; and continuously adding 70G of distilled water, stirring for swelling, and standing for 24 hours to obtain a personal care gel preparation G1.
Example 2 personal Care gel formulation G2 containing Lysozyme
Mixing 0.25g lysozyme, 0.5g subprostrate sophora and 0.25g oxymatrine with 5g tween 80 uniformly to obtain medicinal liquid; adding 15g of glycerol into a mixture of 8g of sodium carboxymethylcellulose and 1g of poloxamer 188, uniformly mixing, and uniformly mixing with the liquid medicine; and continuously adding 70G of distilled water, stirring for swelling, and standing for 24 hours to obtain a personal care gel preparation G2.
Example 3 personal Care gel formulation G3 containing Lysozyme
Mixing 0.25g lysozyme, 0.6g subprostrate sophora and 0.15g oxymatrine with 5g tween 80 to obtain medicinal liquid; adding 15g of glycerol into a mixture of 8g of sodium carboxymethylcellulose and 1g of poloxamer 188, uniformly mixing, and uniformly mixing with the liquid medicine; and continuously adding 70G of distilled water, stirring for swelling, and standing for 24 hours to obtain a personal care gel preparation G3.
Example 4 personal Care gel formulation G4 containing Lysozyme
Mixing 0.25g lysozyme, 0.25g subprostrate sophora and 0.5g oxymatrine with 5g tween 80 to obtain medicinal liquid; adding 15g of glycerol into a mixture of 4.5g of sodium carboxymethylcellulose and 4.5g of poloxamer 188, uniformly mixing, and uniformly mixing with the liquid medicine; and continuously adding 70G of distilled water, stirring for swelling, and standing for 24 hours to obtain a personal care gel preparation G4.
Example 5 personal Care gel formulation G5 containing Lysozyme
Uniformly mixing 0.25g of lysozyme, 0.25g of subprostrate sophora and 0.5g of oxymatrine with 5g of tween 80 to obtain liquid medicine; adding 15g of glycerol into a mixture of 2g of sodium carboxymethylcellulose and 7g of poloxamer 188, uniformly mixing, and uniformly mixing with the liquid medicine; and continuously adding 70G of distilled water, stirring for swelling, and standing for 24 hours to obtain the personal care gel preparation G5.
Comparative example 1 personal Care gel formulation C1 containing Lysozyme
Mixing 0.25g lysozyme, 0.25g subprostrate sophora and 0.5g oxymatrine with 5g tween 80 to obtain medicinal liquid; adding 15g of glycerol into 9g of sodium carboxymethylcellulose, uniformly mixing, and uniformly mixing with the liquid medicine; and continuously adding 70g of distilled water, stirring for swelling, and standing for 24 hours to obtain the personal care gel preparation C1.
Comparative example 2 personal Care gel formulation C2 containing Lysozyme
Mixing 0.25g lysozyme, 0.25g subprostrate sophora and 0.5g oxymatrine with 5g tween 80 to obtain medicinal liquid; adding 15g of glycerol into a mixture of 8g of sodium carboxymethylcellulose and 1g of poloxamer 407, uniformly mixing, and uniformly mixing with the liquid medicine; and continuously adding 70g of distilled water, stirring for swelling, and standing for 24 hours to obtain the personal care gel preparation C2.
Test example 1 curative effect of personal care gel preparation of the present invention in bacterial and mycotic vaginitis of rabbits
1. Test method
1.1, establishment of vaginitis model
Washing vagina of a rabbit with 0.01ml/L phosphate buffer solution for 3 times, injecting 0.2ml of staphylococcus aureus suspension into cervix of the rabbit through a catheter, checking the red and swollen state of vulva and vagina and the condition of secretion after 1 time every day and 3 consecutive days, and taking vaginal and cervical secretion from a vaginal swab and performing smear staining microscopy on the vaginal and cervical secretion. The rabbit vulva and vagina generate obvious edema, and the secretion of the vagina and the cervix contain a large amount of infectious pathogenic bacteria, which indicates that the preparation of the rabbit bacterial vaginitis model is successful.
After the vagina of the rabbit is washed for 3 times by using 0.01ml/L phosphate buffer solution, 0.2ml candida albicans suspension is injected into the cervix of the rabbit through a catheter, 1 time per day is carried out, after 3 consecutive days, the red and swollen state of the vulva and the vagina and the condition of secretion are checked, and the vaginal swab is used for smear staining microscopy of the vaginal and cervical secretion. When the vagina of the rabbit is obviously congested, red and swollen, accompanied by a large amount of purulent secretion and a large amount of infectious bacteria can be seen through microscopic examination, the successful preparation of the rabbit mycotic vaginitis model is proved.
1.2 test groups and dosing regimens
The 60 bacterial vaginitis model rabbits are divided into a model group and test groups 1-5 according to the invention by a numerical method, and each group comprises 10 rabbits. The model group was administered with sterile physiological saline, and the test groups 1 to 5 were administered with the personal care gels prepared in examples 1 to 5 of the present invention, respectively, at a dose of 0.2g gel/kg weight in a micro syringe manner so as to be uniformly distributed in the vagina and cervix, 1 time per day, for 7 days continuously. Observing general behaviors of animals, vulva states and secretion conditions every day, killing the rabbits by an air embolism method after last administration for 24 hours, taking vaginal tissues, fixing the vaginal tissues by 10% neutral formaldehyde, wrapping the vaginal tissues by paraffin, slicing the vaginal tissues, and staining the vaginal tissues by HE (high-intensity electrophoresis) for pathological examination. Grading diagnosis standard of pathological scoring of vaginal tissue biopsy: grading according to four basic indexes of congestion, edema, hemorrhage and inflammatory cell infiltration, wherein the edema without the transfusion is (-) and the mild is (+) and the moderate is (+) and the severe is (+ ++), and the grading is according to the pathological grade, the (-) is 0, the (+) is 1, the (+) is 2 and the + + +) is 3. According to pathological grade integrals of the model rabbits of each test group after treatment, the treatment effect of the personal care gel for treating bacterial vaginitis is investigated.
In addition, 60 model rabbits with mycotic vaginitis are taken, and the treatment effect of the private care gel for treating the mycotic vaginitis is examined according to the grouping scheme, the administration mode and the experimental method of the model rabbits with the bacterial vaginitis.
2. Test results
The effect of the personal care gel formulations of the present invention on bacterial and mycotic vaginitis rabbit models is shown in tables 1 and 2.
TABLE 1 pathological scoring results of bacterial vaginitis rabbit with gel preparation of the present invention
Figure BDA0003691854340000061
TABLE 2 pathological scoring results of the gel preparation of the present invention on rabbit suffering from mycotic vaginitis
Figure BDA0003691854340000062
The test results of the above tables 1 and 2 show that pathological grade scores of the bacterial vaginitis and mycotic vaginitis rabbits treated by the private care gel of the invention 1-5 are both obviously smaller than those of the model group (compared with the model group, the scores have obvious difference), which indicates that the private care gel of the invention can effectively treat gynecological diseases such as vaginitis and the like. Particularly, under the condition that the total amount of the active ingredients is kept unchanged (the total amount of the three active ingredients is 1g/100g of the gel preparation), the treatment effect of the personal care gel (test group 1) containing 1:1:2 lysozyme, subprostrata and oxymatrine is even better than that of the preparation (test groups 2-5) with other proportions, and the unexpected excellent effect is generated.
Test example 2 chemical stability study of personal care gel formulation of the present invention
1. Test method
The test set up 5 test groups, wherein test groups 1-3 used the personal care gel formulations of the present invention prepared in examples 1 and 4-5, respectively, and test groups 4-5 used the personal care gel formulations prepared in comparative examples 1-2, each test group repeating 3 samples. Storing the 5 test groups for 10 days at 60 deg.C and 75% RH respectively, taking out, measuring the content of subprostrata sophora extract and oxymatrine in the preparation of each test group, and calculating the average content of subprostrata sophora extract and oxymatrine in each test group.
2. Test results
The average values of the contents of sophoricoside and oxymatrine in each test group are shown in table 3 below.
TABLE 3 content of subprostrate sophora and oxymatrine in personal care gel preparation of the present invention under high temperature and high humidity
Test group Subprostrate sophora extract content (%) Oxymatrine content (%)
Test group 1 99.21％ 99.08％
Test group 2 98.17％ 97.35％
Test group 3 97.42％ 98.39％
Test group 4 94.57％ 93.75％
Test group 5 93.18％ 94.06％
As can be seen from the data of the content of active ingredients in the above table, the gel formulations of test groups 1 to 3 (examples 1 and 4 to 5) had no significant decrease in the content of both vietnamese and oxymatrine after storage under high temperature and high humidity conditions, and the content of active ingredients was maintained at 97% or more. In contrast, in test 4 (comparative example 1), where poloxamer 188 was omitted, and in test 5 (comparative example 2), where poloxamer 188 was replaced with an equal amount of poloxamer 407, the content of both subprostrata in the gel formulation after storage was less than 95%, indicating that both active ingredients produced a large amount of impurities during storage and that the stability was not good. The results of the above comparative tests show that the gel matrix selected by the invention can effectively inhibit the generation of impurities of subprostrata sophora and oxymatrine, and the gel preparation of the invention is expected to have good stability in the production and storage processes.

Claims (10)

1. The personal care gel preparation is characterized in that the weight ratio of active ingredients of lysozyme, subprostrate sophora and oxymatrine is 1: (1-5): (1-5).
2. The personal care gel formulation of claim 1, wherein the weight ratio of lysozyme, sophoricine, and oxymatrine is 1: (1-3): (1-3).
3. The personal care gel formulation of claim 2, wherein the weight ratio of lysozyme, sophoricidin, and oxymatrine is from 1:1: 2.
4. the personal care gel formulation of any one of claims 1-3, further comprising a pharmaceutically acceptable excipient selected from one or more of a gel base, a humectant, a solubilizer, and a solvent.
5. The personal care gel formulation of claim 4, wherein the gel base is selected from one or more of sodium carboxymethylcellulose, carbomers, poloxamers, and hydroxypropylmethylcellulose; more preferably, the gel matrix is a composition of sodium carboxymethyl cellulose and poloxamer; further preferably, the gel matrix is a composition of sodium carboxymethyl cellulose and poloxamer 188, and the weight ratio of the sodium carboxymethyl cellulose to the poloxamer 188 is (1-10): 1.
6. the personal care gel formulation of claim 4, wherein the humectant is glycerin or propylene glycol.
7. The personal care gel formulation of claim 4, wherein the solubilizing agent is Tween 80 or Tween 60.
8. A method of making the personal care gel formulation of any one of claims 4-7, comprising the steps of:
(1) uniformly mixing lysozyme, subprostrate sophora and oxymatrine with a solubilizer to obtain a liquid medicine;
(2) adding a humectant into the gel matrix, uniformly mixing, and uniformly mixing with the liquid medicine prepared in the step (1);
(3) and (3) adding a solvent into the solution obtained in the step (2), stirring for swelling, and standing for 24 hours to obtain the nano-composite material.
9. Use of an intimate gel formulation according to any of claims 1 to 7 in the manufacture of a medicament for the inhibition of bacteria and/or fungi.
10. Use of a gel matrix composition for increasing the chemical stability of an intimate gel formulation according to any of claims 1 to 7, wherein the gel matrix composition comprises sodium carboxymethylcellulose and poloxamer 188 in a weight ratio (1-10): 1.
CN202210666847.8A 2022-06-13 2022-06-13 Lysozyme-containing personal care gel Pending CN115025209A (en)

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