Medicinal gel solution for infantile eczema and preparation method thereof

Abstract

The invention discloses a medicinal gel liquid for infant eczema and a preparation method thereof, comprising the following steps: step 1, preparing a gel matrix solution; step 2, preparing a drug solution; step 3, mixing and adding; step 4, gel forming; and step 5, pH adjustment and degassing. The advantages of the invention are as follows: a Nocardia rubrum cell wall skeleton emulsion plays a major therapeutic role as an effective component, effectively targeting the cause of eczema while reducing potential risks to infant skin; glycyrrhizic acid has a calming, anti-inflammatory and anti-allergic system, which enhances the overall anti-allergic effect and reduces the incidence of allergic reactions of infant skin to drugs and external stimuli; hyaluronic acid and trehalose can not only alleviate the problem of dry skin that may occur during the treatment of eczema, but also enhance the skin barrier function, which is beneficial to the healthy recovery of the skin; and the proportion of the components can be adjusted according to actual conditions to improve the high adaptability of the drug preparation.

Description

Technical Field

[0001] The invention relates to the technical field of infant medicine, and in particular to a medicinal gel liquid for infant eczema and a preparation method thereof. Background Art

[0002] Infant eczema is a common inflammatory skin disease with a high incidence rate. Because infant skin is delicate and sensitive and has weak resistance to external stimuli, eczema often causes symptoms such as itching, redness, swelling, and desquamation, which seriously affect the quality of life and healthy growth of infants. Some drugs currently on the market for the treatment of infant eczema have many problems. For example, some drugs contain hormones, and long-term use may have adverse effects on the growth and development of infants. The dosage form of some drugs is not suitable for infant skin, and is not easily absorbed after application, and is prone to residue, or has a strong greasy feeling, causing discomfort to infants or even resistance to use. Therefore, drugs used to treat infant eczema need to have higher safety, mildness and effectiveness.

[0003] However, the existing clinical treatment methods for infantile eczema are diverse, but all have certain limitations. Although traditional glucocorticoid drugs can quickly relieve symptoms, long-term use can easily cause adverse reactions such as skin atrophy, pigmentation, and capillary dilation. Especially for the delicate skin of infants and young children, these side effects may pose a potential threat to their future skin health. Non-hormonal drugs such as calcineurin inhibitors are relatively safe, but they may cause local irritation, increase the risk of infection, and are relatively expensive, which limits their widespread application. They can often only relieve a single symptom and are difficult to meet the dual needs of anti-inflammatory and anti-allergic and hydrating and moisturizing at the same time. Some drugs that only focus on anti-inflammatory may cause dryness and desquamation of infant skin, further damaging the skin barrier function, and some simple moisturizing products have little effect on the treatment of eczema. Therefore, there is an urgent need for a medicinal gel solution for infant eczema and a preparation method thereof to improve the treatment effect of infant eczema.

[0004] At present, there is an urgent need for a medicinal gel solution for infant eczema and a preparation method thereof, a new type of pharmaceutical preparation that can effectively treat infant eczema and fully protect and repair the delicate skin of infants and young children. Therefore, the development of a medicinal gel solution for infant eczema and a preparation method thereof has important practical significance. In order to solve the above problems, the present invention proposes a medicinal gel solution for infant eczema and a preparation method thereof. Summary of the invention

[0005] The technical problem to be solved by the present invention is to provide a new type of pharmaceutical preparation which can effectively treat infantile eczema and fully protect and repair the delicate skin of infants and young children, a medicinal gel liquid for infantile eczema and a preparation method thereof.

[0006] In order to solve the above technical problems, the present invention is solved by the following technical solutions: a medicinal gel solution for infant eczema and a preparation method thereof, comprising the following steps:

[0007] Step 1, preparation of gel matrix solution: slowly add the gel matrix into part of the solvent, stirring while adding, the stirring speed is 200-300 rpm, and the stirring is continued until the gel matrix is ​​fully swollen, the swelling time is 18-36 hours, and the gel matrix solution is obtained;

[0008] Step 2, preparation of drug solution: dissolving the Nocardia rubrum cell wall skeleton emulsion and glycyrrhizic acid in the remaining solvent respectively, heating in a water bath, controlling the water temperature at 35-45° C., and stirring at a speed of 300-500 rpm until all components are completely dissolved to obtain a drug solution;

[0009] Step 3, mixing and adding: adding hyaluronic acid and optional trehalose to the drug solution, and continuing stirring for 30 to 60 minutes until the mixture is uniformly mixed;

[0010] Step 4, gel forming: slowly drop the mixed drug solution into the gel matrix solution at a dropping speed of 1-2 ml / s, and stir at a speed of 400-600 rpm to fully mix the two, then add the preservative and stir for 10-20 minutes to make it evenly dispersed;

[0011] Step 5, pH adjustment and degassing: Use an appropriate amount of sodium hydroxide or hydrochloric acid solution to adjust the pH value of the mixed system to 5.0-7.0, and then place it in a vacuum environment for degassing treatment, the vacuum degree is -0.05 to -0.08MPa, and the degassing time is 30 to 60 minutes to obtain a medicinal gel solution for infant eczema.

[0012] Preferably, the gel matrix is ​​first slowly added to part of the solvent and fully swelled under stirring to obtain a gel matrix solution, the swelling time is 12-24 hours, and then 0.01g of glycyrrhizic acid is added to a mixed solution consisting of N-CWS emulsion and PBS (0.01M, pH5.4), mixed and ultrasonically dissolved for 5 minutes to completely dissolve the glycyrrhizic acid, and then the prescribed amount of trehalose (optional), hyaluronic acid, and glycerol (optional) are added, and the mixed drug solution is slowly dripped into the gel matrix solution while stirring at a stirring speed of 300-500 rpm, and then a preservative is added, and after stirring evenly, the pH value is adjusted to 5.5-7.0, and finally it is allowed to stand for degassing, and the glycyrrhizic acid-based N-CWS gel is obtained within 10 minutes.

[0013] Preferably, the following components are included by weight:

[0014] Nocardia rubrum cell wall skeleton emulsion: 3-10 parts;

[0015] Glycyrrhizic acid: 1-5 parts;

[0016] Hyaluronic acid: 2-6 parts;

[0017] Trehalose: 0-4 parts;

[0018] Preservatives: 0.1-0.3 parts;

[0019] Solvent: 50-70 parts.

[0020] Preferably, the gel matrix is ​​one or more selected from carbomer and hydroxypropyl methylcellulose, and the preservative is benzyl alcohol or phenoxyethanol.

[0021] Preferably, the solvent is one or more of water for injection and purified water, the vacuum degree in the degassing step is -0.05 to -0.08 MPa, and the degassing time is 30 to 60 minutes.

[0022] Preferably, the stirring speed in the swelling step is 100-200 rpm, and the heating and dissolving step adopts a water bath heating method.

[0023] Preferably, the dripping speed in the dripping and mixing step is 0.5-1.5 ml / s, and the pH value is adjusted by using one or more of sodium hydroxide solution and hydrochloric acid solution.

[0024] Preferably, when the added amount of trehalose is 0 parts, the proportions of the other components are adjusted accordingly, and good calming, anti-inflammatory, anti-allergic and hydrating and moisturizing effects can still be maintained; when the added amount of glycerol is 0 parts, the proportions of the other components are adjusted accordingly, and good calming, anti-inflammatory, anti-allergic and hydrating and moisturizing effects can still be maintained.

[0025] Preferably, the main effective ingredients of the Nocardia rubra cell wall skeleton emulsion include peptidoglycan, mycolic acid and arabinogalactan. The peptidoglycan is an important component of the bacterial cell wall. In N-CWS, peptidoglycan constitutes its basic skeleton structure. The mycolic acid is a special component in N-CWS, and the arabinogalactan is a component of N-CWS.

[0026] Preferably, the gel matrix solution preparation step: slowly adding the gel matrix to part of the solvent, stirring at a stirring speed of 200-300 rpm until fully swollen, the swelling time is 18-36 hours, to obtain a gel matrix solution; the drug solution preparation step: dissolving the Nocardia rubrum cell wall skeleton emulsion and glycyrrhizic acid in the remaining solvent, heating in a water bath at 35-45° C. and stirring at 300-500 rpm until completely dissolved, to obtain a drug solution; the mixing step: adding hyaluronic acid and trehalose (if any) Add) into the drug solution and stir for 30 to 60 minutes until it is uniform; gel forming step: slowly add the drug solution dropwise into the gel matrix solution at a dropping speed of 1 to 2 ml / s, while stirring at 400 to 600 rpm, then add the preservative and stir for 10 to 20 minutes; pH adjustment and degassing step: adjust the pH value to 5.0-7.0 with sodium hydroxide or hydrochloric acid solution, degas at a vacuum degree of -0.05 to -0.08 MPa for 30 to 60 minutes to obtain a medicinal gel solution for infant eczema.

[0027] Compared with the prior art, the present invention has the following beneficial effects:

[0028] 1. The ingredients selected for the medicinal gel liquid for infant eczema and the preparation method thereof of the present invention are highly safe and mild. The Nocardia rubrum cell wall skeleton emulsion plays a major therapeutic role as an effective ingredient. Its source and mechanism of action have been strictly screened and verified. While effectively targeting the cause of eczema, it minimizes the potential risk of irritation to infant skin. The Nocardia rubrum cell wall skeleton (N-CWS) is a new type of biological immunomodulator, which has the functions of regulating the body's immune function, promoting cytokine secretion, and enhancing the local immune defense ability of the skin. It shows good application prospects in the treatment of various skin diseases. It can stimulate the body's immune system, inhibit inflammatory response, and accelerate skin tissue repair. It has high safety and is not prone to drug resistance and serious adverse reactions, providing a new direction for the treatment of infant eczema.

[0029] 2. The medicinal gel for infant eczema of the present invention and its preparation method The red Nocardia cell wall skeleton emulsion plays a major therapeutic role as an effective ingredient. Peptidoglycan can activate the body's immune system, especially macrophages and dendritic cells. When applied to the eczema site of infants and young children, the immune cells can be activated to engulf harmful pathogens, regulate local immune responses, and reduce the damage of inflammatory responses to the skin of infants and young children; mycolic acid can enhance the recognition ability of immune cells to pathogen-associated molecular patterns (PAMPs), thereby more effectively activating the immune defense mechanism. In the treatment process of infant eczema, the enhancement of recognition ability helps the immune system to accurately respond to skin infections and inflammations, and avoid excessive inflammatory responses from causing further damage to the delicate skin of infants and young children; Arabinogalactan can interact with cell surface receptors in the immune system and regulate the secretion of cytokines. Cytokines play a key role in controlling inflammatory responses and promoting skin repair, which helps to alleviate the symptoms of infant eczema and promote skin healing.

[0030] 3. The medicinal gel solution for infant eczema of the present invention and its preparation method are as follows: Glycyrrhizic acid is a natural active ingredient extracted from licorice, which has multiple pharmacological effects such as anti-inflammatory, anti-allergic, and antioxidant, and can effectively reduce skin inflammation and itching symptoms caused by eczema. It can be used in combination with N-CWS to exert a synergistic therapeutic effect. At the same time, trehalose has good moisturizing and stabilizing biological macromolecular structures, which can enhance the stability of the gel and protect skin cells from damage by the external environment; hyaluronic acid is a highly efficient moisturizer that can increase the moisture content of the skin and repair damaged skin barriers; glycerol also has the function of moisturizing and improving the spreadability of the preparation; glycyrrhizic acid further enhances the overall anti-allergic effect, reduces the incidence of allergic reactions of infant skin to drugs and external stimuli, and provides a comprehensive protective barrier for the delicate skin of infants;

[0031] 4. The medicinal gel solution for infantile eczema of the present invention and the preparation method thereof construct an efficient hydrating and moisturizing network through hyaluronic acid and trehalose (which can be added as needed). Hyaluronic acid can form a moisturizing film on the skin surface, lock a large amount of moisture, keep the skin hydrated, help maintain the normal physiological function of the skin, and promote skin self-repair; trehalose is a natural moisturizer with excellent moisturizing properties and protective effects on biofilms. It can effectively prevent skin moisture loss even in dry or harsh environments, enhance skin barrier function, and is conducive to healthy recovery of the skin;

[0032] 5. The medicinal gel solution for infant eczema of the present invention and the preparation method thereof can adjust the disclosed component ratios according to actual conditions. This feature gives the drug preparation a high degree of adaptability. Infants of different age groups, different disease severity and different skin types have different needs for drugs. For infants with milder conditions, the proportion of the active ingredient, Nocardia rubrum cell wall skeleton emulsion, can be appropriately reduced, and the dosage of auxiliary ingredients can be adjusted accordingly to reduce the burden of the drug on the skin and achieve mild treatment while ensuring the therapeutic effect; for children with more serious conditions and obvious inflammatory reactions, the proportion of the active ingredient can be increased, and the ratio of the sedative, anti-inflammatory and anti-allergic ingredients can be optimized to enhance the therapeutic efficacy of the drug and quickly relieve symptoms. The flexibility enables the drug of the present invention to accurately meet the personalized treatment needs of various types of infant eczema patients and improve the effectiveness and pertinence of the treatment. DETAILED DESCRIPTION

[0033] Unless the context clearly dictates otherwise, unmodified nouns and nouns modified by "the" include singular and plural referents.

[0034] As used in the specification and claims, the terms "comprises," "comprising," "having," "may," "containing," and variations thereof as used herein refer to open transitional phrases, terms, or words that require the presence of specified ingredients / steps and allow for the presence of other ingredients / steps. However, such descriptions should be interpreted as also describing compositions or methods as "consisting of" and "consisting essentially of" the recited ingredients / steps, which allows for the presence of only the specified ingredients / steps and any unavoidable impurities that may result therefrom, and excludes other ingredients / steps.

[0035] Numerical values ​​in the specification and claims of this application should be understood to include the same numerical values ​​when reduced to the same number of significant figures and numerical values ​​that differ from the stated value by less than the experimental error of ordinary measurement techniques of the type described in this application for determining the stated value.

[0036] All ranges disclosed herein are inclusive of the indicated endpoints and are independently combinable (eg, the range of "2 grams to 10 grams" includes the endpoints 2 grams and 10 grams, and all intermediate values).

[0037] The terms "about" and "approximately" can be used to include any numerical value that can be varied without changing the basic function of the value. When used with a range, "about" and "approximately" also disclose the range defined by the absolute values ​​of the two endpoints, for example, "about 2 to about 4" also discloses a range of "2 to 4". Generally, the terms "about" and "approximately" can refer to ±10% of the indicated number. However, for temperature, the term "approximately" refers to ±1°C.

[0038] Unless expressly stated otherwise, the percentages of elements are to be considered as percentages by weight of the alloy in question.

[0039] The present disclosure may refer to the temperature of certain method steps. It should be noted that these specifications generally refer to the temperature set by the heat source (such as a furnace), and not necessarily the temperature that the heated material must reach.

[0040] The following description is used to disclose the present invention and enable those skilled in the art to implement the present invention. The preferred embodiments described below are only examples, and those skilled in the art may think of other obvious variations. The basic principles of the present invention defined in the following description may be used for other embodiments, variations, improvements, equivalents, and other technical solutions that do not deviate from the spirit and scope of the present invention.

[0041] Embodiment 1:

[0042] Weigh 5 parts of Nocardia rubrum cell wall skeleton emulsion, 3 parts of glycyrrhizic acid, 4 parts of hyaluronic acid, 2 parts of trehalose, 12 parts of carbomer, 0.3 parts of phenoxyethanol and 65 parts of water for injection according to weight.

[0043] First, prepare a carbomer solution according to step 1, and the swelling time is 24 hours. Then prepare a drug solution according to step 2, and the water bath temperature is 40°C. Then mix hyaluronic acid and other ingredients according to step 3, and then add the drug solution to the carbomer solution according to step 4, with a dropping speed of 1.5 ml / s and a stirring speed of 500 rpm. Stir for 15 minutes after adding phenoxyethanol. Finally, adjust the pH value to 6.0 according to step 5, degas at a vacuum degree of -0.06MPa for 45 minutes to obtain a gel solution.

[0044] Embodiment 2:

[0045] Weigh 4 parts of Nocardia rubrum cell wall skeleton emulsion, 2 parts of glycyrrhizic acid, 3 parts of hyaluronic acid, 10 parts of carbomer, 0.2 parts of phenoxyethanol, and 70 parts of water for injection (trehalose is not added in this example) by weight.

[0046] The preparation process is similar to that of Example 1, wherein the carbomer solution is prepared first, and then the drug solution is prepared. After mixing, the mixture is added dropwise to form the solution, and the pH value is adjusted to 6.5. The solution is degassed to obtain a gel solution.

[0047] Comparative Example 1:

[0048] A conventional eczema gel formula without glycyrrhizic acid, hyaluronic acid and trehalose and without anti-allergic and moisturizing auxiliary ingredients was used to prepare the gel according to a conventional method for comparative experiments on efficacy and safety with the examples of the present invention.

[0049] Experimental example:

[0050] A certain number of children diagnosed with infantile eczema were selected and randomly divided into a treatment group (using the gel solution of Example 1 or 2 of the present invention) and a control group (using the gel of Comparative Example 1). The treatment was carried out according to the prescribed medication method and course of treatment, and the disappearance of eczema in the two groups of children, the skin state and the presence or absence of adverse reactions were observed. The results showed that the symptoms of eczema in the children in the treatment group were significantly improved, the skin redness, swelling, itching and the like were alleviated, and no obvious adverse reactions occurred, while the control group was inferior to the treatment group in terms of efficacy and skin protection, indicating that the medical gel solution for infantile eczema of the present invention has significant advantages.

[0051] Example 3: Preparation of trehalose-containing medicinal gel for infantile eczema

[0052] Formula (parts by weight):

[0053] 5 parts of Nocardia rubrum cell wall skeleton emulsion

[0054] 3 parts of glycyrrhizic acid

[0055] 4 parts of hyaluronic acid

[0056] 2 parts of trehalose

[0057] Carbomer 12 parts

[0058] Phenoxyethanol 0.3 parts

[0059] Water for injection 65 parts

[0060] Preparation steps:

[0061] 1. Preparation of gel matrix solution: Slowly add carbomer to 30 parts of water for injection, and continue stirring at a stirring speed of 250 rpm until the carbomer is fully swollen. The swelling time is 24 hours to obtain a carbomer solution.

[0062] 2. Preparation of drug solution: Dissolve the Nocardia rubrum cell wall skeleton emulsion and glycyrrhizic acid in the remaining 35 parts of water for injection respectively, heat to 40°C in a water bath, and stir at 400 rpm until all components are completely dissolved to obtain a drug solution.

[0063] 3. Mixing and adding: Add hyaluronic acid and trehalose to the drug solution and continue stirring for 45 minutes until the mixture is evenly mixed.

[0064] 4. Gel formation: Slowly add the drug solution to the carbomer solution, control the dropping speed at 1.5 ml / s, and stir at 500 rpm to fully mix the two. Then add phenoxyethanol and stir for 15 minutes to make it evenly dispersed.

[0065] 5. pH adjustment and degassing: Use sodium hydroxide solution to adjust the pH value of the mixed system to 6.0, and then place it in a vacuum environment for degassing treatment with a vacuum degree of -0.06MPa and a degassing time of 45 minutes to obtain a medicinal gel solution for infant eczema.

[0066] Example 4: Preparation of a medicinal gel solution for infantile eczema without trehalose

[0067] Formula (parts by weight):

[0068] 4 parts of Nocardia rubrum cell wall skeleton emulsion

[0069] 2 parts of glycyrrhizic acid

[0070] 3 parts of hyaluronic acid

[0071] Carbomer 10 parts

[0072] Phenoxyethanol 0.2 parts

[0073] Water for injection 70 parts

[0074] Preparation steps:

[0075] 1. Preparation of gel matrix solution: Carbomer was added to 35 parts of water for injection, and the mixture was stirred and swelled at 200 rpm for 30 hours to obtain a carbomer solution.

[0076] 2. Preparation of drug solution: dissolve the Nocardia rubrum cell wall skeleton emulsion and glycyrrhizic acid in the remaining 35 parts of water for injection, heat to 38° C. in a water bath, and stir at 350 rpm until completely dissolved to obtain a drug solution.

[0077] 3. Mixing and adding: Add hyaluronic acid to the drug solution and stir for 30 minutes to mix well.

[0078] 4. Gel formation: Slowly drip the drug solution into the carbomer solution at a dripping rate of 1 ml / s, stir and mix at 400 rpm, add phenoxyethanol and stir for 10 minutes.

[0079] 5. pH adjustment and degassing: adjust the pH to 6.5 with hydrochloric acid solution, degas at -0.05 MPa vacuum for 30 minutes to obtain a gel solution.

[0080] Comparative Example 2: Conventional eczema gel (without key auxiliary ingredients)

[0081] Formula (parts by weight):

[0082] 6 parts of Nocardia rubrum cell wall skeleton emulsion

[0083] Carbomer 15 parts

[0084] Phenoxyethanol 0.4 parts

[0085] Water for injection 78.6 parts

[0086] Preparation steps:

[0087] 1. Add carbomer to 40 parts of water for injection and stir to swell for 20 hours.

[0088] 2. Dissolve the Nocardia rubra cell wall skeleton emulsion in the remaining water for injection, heat to 42°C and stir to dissolve.

[0089] 3. Mix the two, add phenoxyethanol, stir evenly, adjust the pH to 5.5, and vacuum degas (vacuum degree -0.07MPa, degassing time 50 minutes).

[0090] Experimental example: comparative experiment on efficacy and safety

[0091] Experimental subjects: 120 children diagnosed with infantile eczema were selected and randomly divided into three groups, each with 40 cases. The gel solution of Example 3, the gel solution of Example 4 and the gel of Comparative Example 2 were used respectively.

[0092] Experimental method: According to the prescribed medication method, apply the corresponding gel to the eczema area of ​​the children 2-3 times a day for 4 consecutive weeks, and observe and record the improvement of eczema symptoms and the occurrence of adverse skin reactions (such as redness, swelling, itching, dryness, etc.) in each group of children.

[0093] Experimental results:

[0094] Treatment effect: The eczema symptoms of the children in Example 3 and Example 4 groups were significantly alleviated after 2 weeks of treatment. After 4 weeks of treatment, the eczema cure rates reached 70% and 65%, respectively, while the cure rate of the comparative example 1 group was only 30%.

[0095] Safety: Only a very small number of children in Example 3 and Example 4 groups experienced mild and transient skin redness, and no other serious adverse reactions occurred; in the comparative example 2 group, more children experienced dry skin and aggravated itching, etc.

[0096] Embodiment 5: A medicinal gel solution for infantile eczema and a preparation method thereof, comprising the following steps:

[0097] Step 1: Preparation of gel matrix solution:

[0098] Slowly add the gel matrix to part of the solvent while stirring at a speed of 200-300 rpm, and continue stirring until the gel matrix is ​​fully swollen for 18-36 hours to obtain a gel matrix solution;

[0099] Step 2: Preparation of drug solution:

[0100] Dissolve the Nocardia rubrum cell wall skeleton emulsion and glycyrrhizic acid in the remaining solvent respectively, use a water bath heating method to control the water temperature at 35-45° C., and stir at a speed of 300-500 rpm until all components are completely dissolved to obtain a drug solution;

[0101] Step 3: Mixing and adding:

[0102] Add hyaluronic acid and optional trehalose to the drug solution and continue stirring for 30 to 60 minutes until the mixture is uniform;

[0103] Step 4: Gel Forming:

[0104] Slowly drop the mixed drug solution into the gel matrix solution at a dropping speed of 1-2 ml / s, and stir at a speed of 400-600 rpm to fully mix the two, then add the preservative and stir for 10-20 minutes to make it evenly dispersed;

[0105] Step 5: pH adjustment and degassing:

[0106] An appropriate amount of sodium hydroxide or hydrochloric acid solution is used to adjust the pH value of the mixed system to 5.0-7.0, and then the mixed system is placed in a vacuum environment for degassing treatment with a vacuum degree of -0.05 to -0.08 MPa and a degassing time of 30 to 60 minutes to obtain a medicinal gel solution for infant eczema.

[0107] The specific steps are as follows: the staff slowly adds the gel matrix to part of the solvent, stirring while adding, the stirring speed is 200-300 rpm, and the stirring is continued until the gel matrix is ​​fully swollen, the swelling time is 18-36 hours, and the gel matrix solution is obtained. At this time, the staff then dissolves the red Nocardia cell wall skeleton emulsion and glycyrrhizic acid in the remaining solvent respectively, and 0.01g of glycyrrhizic acid is added to the mixed solution composed of N-CWS emulsion and PBS (0.01M, pH5.4), and mixed ultrasonically for 5 minutes to completely dissolve the glycyrrhizic acid, and adopts a water bath heating method to control the water temperature at 35-45°C, and stirs at a speed of 300-500 rpm until all components are completely dissolved to obtain a drug solution. At this time The staff adds hyaluronic acid and optional trehalose to the drug solution and continues stirring for 30 to 60 minutes until it is evenly mixed. At this time, the staff slowly drips the mixed drug solution into the gel matrix solution, and the dripping speed is controlled at 1-2 ml / s. At the same time, it is stirred at a speed of 400-600 rpm to fully mix the two. Then, a preservative is added and stirred for 10 to 20 minutes to make it evenly dispersed. Finally, the staff uses an appropriate amount of sodium hydroxide or hydrochloric acid solution to adjust the pH value of the mixed system to 5.0-7.0, and then places it in a vacuum environment for degassing treatment. The vacuum degree is -0.05 to -0.08MPa, and the degassing time is 30 to 60 minutes to obtain a medicinal gel solution for infant eczema.

[0108] Those skilled in the art should understand that the above description and the embodiments of the present invention shown are only examples and do not limit the present invention. The purpose of the present invention has been fully and effectively achieved. The functions and structural principles of the present invention have been demonstrated and explained in the embodiments. Without departing from the principles, the embodiments of the present invention may have any deformation or modification. Although the embodiments of the present invention have been shown and described, it is understood by those of ordinary skill in the art that various changes, modifications, substitutions and variations can be made to these embodiments without departing from the principles and spirit of the present invention. The scope of the present invention is defined by the attached claims and their equivalents. This specific embodiment is only an explanation of the present application, and it is not a limitation of the present application. After reading this specification, those skilled in the art can make modifications to the present embodiment without creative contribution as needed, but as long as they are within the scope of the claims of the present application, they are protected by the patent law.

Claims

1. A medicinal gel solution for infantile eczema and a preparation method thereof, characterized in that: The following steps are involved: Step 1, preparation of gel matrix solution: slowly add the gel matrix into part of the solvent, stirring while adding, the stirring speed is 200-300 rpm, and the stirring is continued until the gel matrix is ​​fully swollen, the swelling time is 18-36 hours, and the gel matrix solution is obtained; Step 2, preparation of drug solution: dissolving the Nocardia rubrum cell wall skeleton emulsion and glycyrrhizic acid in the remaining solvent respectively, heating in a water bath, controlling the water temperature at 35-45° C., and stirring at a speed of 300-500 rpm until all components are completely dissolved to obtain a drug solution; Step 3, mixing and adding: adding hyaluronic acid and optional trehalose to the drug solution, and continuing stirring for 30 to 60 minutes until the mixture is uniformly mixed; Step 4, gel forming: slowly drop the mixed drug solution into the gel matrix solution at a dropping speed of 1-2 ml / s, and stir at a speed of 400-600 rpm to fully mix the two, then add the preservative and stir for 10-20 minutes to make it evenly dispersed; Step 5, pH adjustment and degassing: Use an appropriate amount of sodium hydroxide or hydrochloric acid solution to adjust the pH value of the mixed system to 5.0-7.0, and then place it in a vacuum environment for degassing treatment, the vacuum degree is -0.05 to -0.08MPa, and the degassing time is 30 to 60 minutes to obtain a medicinal gel solution for infant eczema.

2. A medicinal gel solution for infantile eczema and a preparation method thereof according to claim 1, characterized in that: First, the gel matrix is ​​slowly added to part of the solvent and fully swelled under stirring to obtain a gel matrix solution. The swelling time is 12-24 hours. Then, 0.01 g of glycyrrhizic acid is added to a mixed solution consisting of N-CWS emulsion and PBS (0.01 M, pH 5.4). The mixture is ultrasonically mixed for 5 minutes to completely dissolve the glycyrrhizic acid. Then, the prescribed amount of trehalose (optional), hyaluronic acid, and glycerol (optional) are added. The mixed drug solution is slowly dripped into the gel matrix solution while stirring at a speed of 300-500 rpm. Then, a preservative is added. After stirring evenly, the pH value is adjusted to 5.5-7.

0. Finally, the mixture is allowed to stand for degassing to obtain a glycyrrhizic acid-based N-CWS gel within 10 minutes.

3. A medicinal gel solution for infantile eczema and a preparation method thereof according to claim 1, characterized in that: By weight, it contains the following components: Nocardia rubrum cell wall skeleton emulsion: 3-10 parts; Glycyrrhizic acid: 1-5 parts; Hyaluronic acid: 2-6 parts; Trehalose: 0-4 parts; Preservatives: 0.1-0.3 parts; Solvent: 50-70 parts.

4. A medicinal gel solution for infantile eczema and a preparation method thereof according to claim 1, characterized in that: The gel matrix is ​​one or more selected from carbomer and hydroxypropyl methylcellulose, and the preservative is benzyl alcohol or phenoxyethanol.

5. The medicinal gel solution for infantile eczema and the preparation method thereof according to claim 1, characterized in that: The solvent is one or more of water for injection and purified water. The vacuum degree in the degassing step is -0.05 to -0.08 MPa, and the degassing time is 30 to 60 minutes.

6. The medicinal gel solution for infantile eczema and the preparation method thereof according to claim 1, characterized in that: The stirring speed in the swelling step is 100-200 rpm, and the heating and dissolving step adopts a water bath heating method.

7. The medicinal gel solution for infantile eczema and the preparation method thereof according to claim 1, characterized in that: The dripping speed in the dripping and mixing step is 0.5-1.5 ml / s, and the pH value is adjusted by using one or more of sodium hydroxide solution and hydrochloric acid solution.

8. The medicinal gel solution for infantile eczema and its preparation method according to claim 2, characterized in that: When the added amount of trehalose is 0 parts, the proportions of the other components are adjusted accordingly, and good calming, anti-inflammatory, anti-allergic and hydrating and moisturizing effects can still be maintained. When the added amount of glycerol is 0 parts, the proportions of the other components are adjusted accordingly, and good calming, anti-inflammatory, anti-allergic and hydrating and moisturizing effects can still be maintained.

9. The medicinal gel solution for infantile eczema and the preparation method thereof according to claim 1, characterized in that: The main effective ingredients of the Nocardia rubrum cell wall skeleton emulsion include peptidoglycan, mycolic acid and arabinogalactan. The peptidoglycan is an important component of the bacterial cell wall. In N-CWS, peptidoglycan constitutes its basic skeleton structure. The mycolic acid is a special component in N-CWS, and the arabinogalactan is a component of N-CWS.

10. A medicinal gel solution for infantile eczema and a preparation method thereof according to claims 1-9, characterized in that: The following steps are involved: Preparation steps of the gel matrix solution: slowly adding the gel matrix into a portion of the solvent, stirring at a stirring speed of 200-300 rpm until fully swollen, the swelling time being 18-36 hours, to obtain a gel matrix solution; The steps of preparing the drug solution are as follows: dissolving the Nocardia rubrum cell wall skeleton emulsion and glycyrrhizic acid in the remaining solvent respectively, heating in a water bath at 35-45° C. and stirring at 300-500 rpm until completely dissolved, to obtain a drug solution; Mixing step: Add hyaluronic acid and trehalose (if added) to the drug solution and stir for 30 to 60 minutes until uniform; Gel forming step: slowly add the drug solution to the gel matrix solution at a dropping speed of 1-2 ml / s while stirring at 400-600 rpm, then add the preservative and stir for 10-20 minutes; pH adjustment and degassing steps: adjust the pH value to 5.0-7.0 with sodium hydroxide or hydrochloric acid solution, degas for 30-60 minutes at a vacuum degree of -0.05 to -0.08 MPa to obtain a medicinal gel solution for infant eczema.