A gel composition, uses and methods of preparation

Abstract

The application discloses a gel composition, application and preparation method, relates to the technical field of gels. The gel composition comprises luteolin and glycyrrhizic acid; the concentration of the luteolin is 0.5 mg / ml to 2 mg / ml, and the concentration of the glycyrrhizic acid is 5 mg / ml to 20 mg / ml. Through self-assembly of the luteolin and the glycyrrhizic acid, a carrier-free supramolecular hydrogel is formed, the use of high-molecular excipients is avoided, the risk of skin irritation is reduced, the preparation process is simplified, and effective synergistic treatment of psoriasis can be realized.

Description

Technical Field

[0001] This application belongs to the field of gel technology, specifically relating to a gel composition, its application, and its preparation method. Background Technology

[0002] Psoriasis is a skin disease caused by multiple factors. Patients with psoriasis experience intense itching, and in severe cases, may experience chills and high fever. Furthermore, due to its clinical manifestations of thickened, red, and scaly skin, psoriasis significantly negatively impacts patients' social activities and mental health.

[0003] Topical gels are a common dosage form for treating psoriasis, exerting their therapeutic effect by applying the gel to the affected area. However, existing gels generally suffer from poor efficacy and are prone to causing skin irritation and other side effects. Furthermore, the preparation of current gels requires numerous components, making the process cumbersome and hindering large-scale production. Summary of the Invention

[0004] This application provides a gel composition, its application, and a preparation method, enabling the rapid preparation of a gel for treating psoriasis based on two natural components. The technical solution provided in this application is as follows: In a first aspect, embodiments of this application provide a gel composition comprising luteolin and glycyrrhizic acid; wherein the concentration of luteolin in the gel composition is from 0.5 mg / ml to 2 mg / ml, and the concentration of glycyrrhizic acid in the gel composition is from 5 mg / ml to 20 mg / ml.

[0005] Optionally, the concentration of luteolin in the gel composition is 1 mg / ml, and the concentration of glycyrrhizic acid in the gel composition is 10 mg / ml.

[0006] Secondly, embodiments of this application provide the use of the above-described gel composition in the preparation of a medicament for treating psoriasis.

[0007] Thirdly, embodiments of this application provide a method for preparing a gel for treating psoriasis, comprising: dissolving luteolin in water, and adding sodium hydroxide solution to the obtained luteolin aqueous solution until the luteolin aqueous solution becomes transparent, obtaining a luteolin solution with a concentration of 0.5 mg / ml to 2 mg / ml; dissolving glycyrrhizic acid in water, and heating the obtained glycyrrhizic acid aqueous solution to a transparent state, obtaining a glycyrrhizic acid solution with a concentration of 5 mg / ml to 20 mg / ml; mixing the luteolin solution and the glycyrrhizic acid solution, and heating the obtained mixed solution until a transparent mixed solution is obtained; adding hydrochloric acid solution to the transparent mixed solution to adjust the acidity of the solution, and cooling the obtained acidic mixed solution to obtain a gel for treating psoriasis.

[0008] Optionally, the concentration of the luteolin solution is 1 mg / ml, and the concentration of the glycyrrhizic acid solution is 10 mg / ml.

[0009] Optionally, the concentration of sodium hydroxide in the sodium hydroxide solution is 1 mol / L; the concentration of hydrochloric acid in the hydrochloric acid solution is 1 mol / L.

[0010] Optionally, the pH of the acidic mixed solution is 4 to 5.

[0011] Optionally, the pH of the acidic mixed solution is 5.

[0012] Optionally, the cooling process involves cooling the acidic mixed solution to 20°C to 30°C.

[0013] Optionally, the heating temperature of the glycyrrhizic acid aqueous solution is 80°C; the heating temperature of the mixed solution is 80°C.

[0014] In summary, one or more technical solutions provided in the embodiments of this application have at least the following technical effects or advantages: Using luteolin and glycyrrhizic acid at specific concentrations as core components, this method leverages their physicochemical properties under specific acid-base and temperature conditions to achieve self-assembly. Sodium hydroxide is used to adjust the solubility of luteolin, and heating promotes the dissolution of glycyrrhizic acid, ensuring thorough dispersion of the two active molecules in the liquid phase. Mixing and maintaining heating enhances intermolecular movement and contact. Adding hydrochloric acid adjusts the pH to an acidic range, inducing a deprotonation-to-protonation transition in luteolin and glycyrrhizic acid molecules, triggering non-covalent interactions such as hydrogen bonding and π-π stacking, leading to spontaneous aggregation and the formation of a stable three-dimensional network structure. This network structure is then fixed through cooling, resulting in a supramolecular hydrogel that requires no polymeric carrier or chemical cross-linking agent. This process effectively solves the problems of high skin irritation, numerous formulation components, and complex preparation processes associated with traditional gel formulations due to the introduction of exogenous excipients. The resulting gel composition not only retains the pharmacological activities of luteolin and glycyrrhizic acid, achieving a synergistic effect in treating psoriasis, but also significantly improves the product's biocompatibility and safety due to its carrier-free nature. At the same time, the simplified preparation process facilitates cost control and quality uniformity in industrial production, providing a novel drug delivery gel that is highly efficient, safe, and easy to promote for the treatment of psoriasis.

[0015] This application ingeniously utilizes the supramolecular self-assembly characteristics of natural active ingredients to construct a novel gel system that integrates drug efficacy and matrix function, achieving green preparation of the entire chain from raw materials to final products, and has significant systemic advantages and application value.

[0016] The above description is only an overview of the technical solution of this application. In order to better understand the technical means of this application and to implement it in accordance with the contents of the specification, and to make the above and other objects, features and advantages of this application more easily understood, specific embodiments of this application are given below. Attached Figure Description

[0017] The accompanying drawings, which are incorporated in and form part of this specification, illustrate embodiments consistent with this application and, together with the description, serve to explain the principles of this application. It is obvious that the drawings described below are merely some embodiments of this application, and those skilled in the art can obtain other drawings based on these drawings without any inventive effort.

[0018] Figure 1 This is a schematic diagram of the preparation process of luteolin and glycyrrhizic acid self-assembling to form a supramolecular hydrogel.

[0019] Figure 2 These are photographs of glycyrrhizic acid / luteolin supramolecular hydrogels formed under different pH values ​​and concentration ratios.

[0020] Figure 3 This is a timeline diagram illustrating the establishment and treatment experiments of the imimod-induced psoriasis mouse model.

[0021] Figure 4 These are comparative photos showing the improvement of skin lesions on the backs of psoriatic mice in different treatment groups.

[0022] Figure 5 This is a line graph showing the effect of different treatment groups on the change in body weight of psoriatic mice.

[0023] Figure 6 This is a line graph showing the effect of different treatment groups on the PASI score of psoriatic mice. Detailed Implementation

[0024] Exemplary embodiments will now be described in detail, examples of which are illustrated in the accompanying drawings. When the following description relates to the drawings, unless otherwise indicated, the same numbers in different drawings represent the same or similar elements. The embodiments described in the following exemplary embodiments do not represent all embodiments consistent with this application. Rather, they are merely examples of apparatuses and methods consistent with some aspects of this application as detailed in the appended claims.

[0025] The block diagrams shown in the accompanying drawings are merely functional entities and do not necessarily correspond to physically independent entities. That is, these functional entities can be implemented in software, in one or more hardware modules or integrated circuits, or in different network and / or processor devices and / or microcontroller devices.

[0026] The flowcharts shown in the accompanying drawings are merely illustrative and do not necessarily include all content and operations / steps, nor do they necessarily have to be performed in the described order. For example, some operations / steps can be broken down, while others can be combined or partially combined; therefore, the actual execution order may change depending on the specific circumstances.

[0027] Glycyrrhizic acid is a natural product with anti-inflammatory activity and various pharmacological activities. Glycyrrhizic acid and its derivatives have been used to treat chronic inflammation, such as chronic viral hepatitis and atopic dermatitis.

[0028] Luteolin is a natural flavonoid compound derived from various vegetables and fruits. Recent studies have shown its potential in treating psoriasis, primarily through multiple mechanisms including anti-inflammatory, immune-regulating, and skin barrier-repairing effects.

[0029] This application utilizes the supramolecular assembly capabilities of the natural products luteolin and glycyrrhizic acid to form a supramolecular hydrogel through non-covalent interactions such as hydrophobic interactions, π-π stacking, and hydrogen bonds. No additional polymeric carriers or chemical cross-linking agents are required. The preparation method utilizes the principle of alkali dissolution and acid precipitation to induce the self-assembly of the two active ingredients. This hydrogel exhibits anti-inflammatory, antioxidant, and immunomodulatory activities, and shows good therapeutic effects on an imiquimod-induced mouse psoriasis model, making it suitable for preparing drugs to treat psoriasis.

[0030] The first aspect of this application provides a gel composition comprising luteolin and glycyrrhizic acid; the concentration of luteolin in the gel composition is from 0.5 mg / ml to 2 mg / ml, and the concentration of glycyrrhizic acid in the gel composition is from 5 mg / ml to 20 mg / ml. In this application, by limiting the specific concentration range of luteolin and glycyrrhizic acid, a stable supramolecular network structure can be formed between the two in an aqueous environment, thereby solving the problems of high skin irritation and poor biocompatibility caused by the reliance on synthetic polymer carriers in existing gel formulations. Its beneficial effect lies in constructing a "carrier-free" drug delivery system, which reduces the risk of adverse reactions caused by excipients and ensures that both active ingredients can exert anti-inflammatory and anti-proliferative pharmacological effects. Furthermore, within this concentration range, the solubility of luteolin can reach a clear state after alkali adjustment, and glycyrrhizic acid can be completely dissolved under heating conditions and participate in efficient self-assembly. The gel formed by the synergistic effect of the two has suitable mechanical strength and extensibility, making it suitable for topical skin application.

[0031] As an optional implementation, this application provides a gel composition. The concentration of luteolin in the gel composition is 1 mg / ml, and the concentration of glycyrrhizic acid in the gel composition is 10 mg / ml. By introducing this technical feature, the molar ratio of luteolin to glycyrrhizic acid reaches an optimal balance point, thereby further improving gel formation and transdermal absorption efficiency. Specifically, at this specific concentration combination, the intermolecular hydrogen bonds and π-π stacking forces are strongest, resulting in the most dense and uniform gel microstructure. This avoids insufficient gel strength due to too low a concentration or precipitation caused by too high a concentration, significantly improving the clinical applicability and efficacy consistency of the product.

[0032] A second aspect of this application provides the use of the gel composition of any of the above embodiments in the treatment of psoriasis. A gel composition comprising luteolin at a concentration of 0.5 mg / ml to 2 mg / ml and glycyrrhizic acid at a concentration of 5 mg / ml to 20 mg / ml is used to prepare a drug for treating psoriasis. By applying this supramolecular hydrogel with specific concentrations to the treatment of psoriasis, the synergistic mechanism of luteolin inhibiting the NF-κB pathway to reduce inflammation and glycyrrhizic acid regulating immune response and inhibiting T cell activation can be utilized. This solves the problems of insufficient specificity and low safety with long-term use of existing topical preparations. Its beneficial effects include effectively alleviating symptoms of erythema, scaling, and epidermal thickening in a psoriasis model, reducing PASI scores, and no obvious toxic reactions were observed, providing a natural, safe, and effective alternative treatment.

[0033] A third aspect of this application provides a method for preparing a gel for treating psoriasis, comprising: dissolving luteolin in water, and adding sodium hydroxide solution to the resulting luteolin aqueous solution until the luteolin aqueous solution becomes transparent, obtaining a luteolin solution with a concentration of 0.5 mg / ml to 2 mg / ml; dissolving glycyrrhizic acid in water, and heating the resulting glycyrrhizic acid aqueous solution to a transparent state, obtaining a glycyrrhizic acid solution with a concentration of 5 mg / ml to 20 mg / ml; mixing the luteolin solution and the glycyrrhizic acid solution, and heating the resulting mixed solution until a transparent mixed solution is obtained; adding hydrochloric acid solution to the transparent mixed solution to adjust the acidity of the solution, and cooling the resulting acidic mixed solution to obtain a gel for treating psoriasis. In this application, a four-step process of alkali dissolution, thermal dissolution, mixed heating, and acidification cooling is set up. The molecular state is controlled by pH response. Specifically, luteolin is deprotonated and dissolved under alkaline conditions, and glycyrrhizic acid is heated to enhance fluidity. After the two are mixed, they are reprotonated in a weakly acidic environment to trigger non-covalent self-assembly. This solves the problems of cumbersome existing gel preparation processes and dependence on additional cross-linking agents. Its beneficial effect is that it realizes a green manufacturing path that completes gelation by relying only on the properties of the two active ingredients. The whole process does not require a polymer backbone, the process is simple and controllable, suitable for large-scale production, and the final product maintains a high content of active ingredients and has good skin compatibility.

[0034] As an optional implementation, this application provides a method for preparing a gel for treating psoriasis. The concentration of the luteolin solution is 1 mg / ml, and the concentration of the glycyrrhizic acid solution is 10 mg / ml. By introducing this technical feature, the mass transfer efficiency during the dissolution and mixing process of the raw materials is optimized, thereby further improving the preparation cycle and the uniformity of the final product. At this concentration, luteolin can be rapidly and completely dissolved under low-concentration NaOH conditions, reducing the risk of alkali residue. Glycyrrhizic acid can quickly reach a transparent state when heated to 80°C. After mixing and heating, the system is more likely to form a homogeneous and transparent solution, which facilitates subsequent acidification-induced ordered self-assembly. The final gel has a uniform texture, no particle feel, and a short gelation time with high stability.

[0035] As an optional implementation, this application provides a method for preparing a gel for treating psoriasis. The sodium hydroxide solution contains 1 mol / L sodium hydroxide, and the hydrochloric acid solution contains 1 mol / L hydrochloric acid. By introducing this technical feature, the pH adjustment process is precisely controllable without introducing excessive impurities, thereby further improving reaction kinetic efficiency and process reproducibility. Specifically, 1 mol / L NaOH is sufficient to rapidly deprotonate and dissolve luteolin while avoiding excessive concentration that could damage the molecular structure. 1 mol / L HCl allows for precise control of the pH decrease rate during slow addition, preventing localized high acidity from causing uneven precipitation or gel structure defects, ensuring consistency between batches and facilitating quality traceability under GMP conditions.

[0036] As an optional implementation, this application provides a method for preparing a gel for treating psoriasis. The pH of the acidic mixed solution is 4 to 5, which allows luteolin and glycyrrhizic acid molecules to undergo moderate protonation in a weakly acidic environment, thereby achieving a balance between triggering effective self-assembly and avoiding excessive aggregation and precipitation. The beneficial effect is that within this pH range, it can smoothly transition to a gel state, and the formed gel has suitable viscoelasticity, water-holding capacity, and drug release characteristics. At the same time, this pH is close to the physiological environment of the skin, which helps to reduce irritation during medication. If the pH is too high, strong charge repulsion will prevent gel formation, and if the pH is too low, precipitation is likely to occur.

[0037] As an optional implementation, this application provides a method for preparing a gel for treating psoriasis. The pH of the acidic mixed solution is 5, which places the system near the isoelectric point of luteolin and glycyrrhizic acid, minimizing the net molecular charge and maximizing intermolecular attraction. This further enhances the gel's mechanical strength, stability, and transparency. Specifically, the supramolecular network formed at this pH is the most dense and uniform, and the in vitro release curve shows stable and sustained drug release, meeting the requirements for long-acting local treatment. Animal experiments have also confirmed that the gel prepared under these conditions shows the most significant improvement in psoriasis symptoms.

[0038] As an alternative approach, this application provides a method for preparing a gel for treating psoriasis. The cooling process involves cooling an acidic mixed solution to 20°C to 30°C, ensuring a moderate cooling rate during gel formation. This promotes orderly molecular arrangement, further enhancing the optimization of the gel's microstructure and improving user comfort. Specifically, slow cooling to room temperature facilitates the full development of the supramolecular network, avoiding structural disorder or increased brittleness caused by rapid cooling. Furthermore, 20–30°C is close to human body temperature, which is conducive to forming a soft gel texture suitable for skin application, less prone to cracking or dripping. This condition also eliminates the need for additional refrigeration equipment, simplifying the process.

[0039] As an optional implementation, this application provides a method for preparing a gel for treating psoriasis. The heating temperature of the glycyrrhizic acid aqueous solution is 80°C; the heating temperature of the mixed solution is 80°C. By introducing this technical feature, the solubility of glycyrrhizic acid is significantly improved, and the increased molecular motion promotes interaction, thereby further improving drug stability and achieving sufficient homogenization. 80°C is sufficient to complete dissolution and homogenization, but it is lower than the degradation temperature of most active ingredients, ensuring drug stability. At the same time, this temperature can be easily achieved by conventional water bath, with low equipment requirements, suitable for large-scale continuous production. It promotes the contact and interaction between luteolin and glycyrrhizic acid, which is beneficial to the uniform formation of the subsequent gel network.

[0040] Unless otherwise specified, all materials, reagents and instruments used in the embodiments of this application can be obtained through commercial channels.

[0041] Key raw materials: luteolin (purity ≥98%), glycyrrhizic acid (purity ≥98%); sodium hydroxide and hydrochloric acid were of analytical grade; the experimental water was ultrapure water.

[0042] Instruments and equipment: constant temperature water bath, pH meter, magnetic stirrer, electronic balance.

[0043] Characterization and testing methods: Digital photography was used to observe the gel morphology; evaluation indicators for the psoriasis model included macroscopic observation of skin lesions, monitoring of weight changes, and PASI (Psoriasis Area and Severity Index) scores.

[0044] Example 1 This embodiment provides an optimally formulated luteolin-glycyrrhizic acid supramolecular hydrogel and its preparation method.

[0045] The steps are as follows: (1) Weigh out luteolin and dissolve it in ultrapure water. Add 1 mol / L sodium hydroxide solution dropwise while stirring until the solution changes from turbid to completely transparent, obtaining a luteolin solution with a concentration of 1 mg / ml. For example... Figure 1 As shown, Figure 1 This diagram illustrates the preparation process of supramolecular hydrogels formed by the self-assembly of luteolin and glycyrrhizic acid. The diagram clearly shows the entire process mechanism from raw material dissolution, alkali adjustment, mixing and heating to acidification and cooling to form a gel.

[0046] (2) Weigh out glycyrrhizic acid and dissolve it in ultrapure water. Place it in an 80°C constant temperature water bath and heat and stir until the solution becomes completely transparent to obtain a glycyrrhizic acid solution with a concentration of 10 mg / ml.

[0047] (3) Mix the luteolin solution obtained in step (1) with the glycyrrhizic acid solution obtained in step (2), and continue to heat and stir at 80°C until the mixed solution becomes clear and transparent.

[0048] (4) Slowly add 1 mol / L hydrochloric acid solution to the transparent mixed solution obtained in step (3) to adjust the pH value of the solution to 5, then stop heating and let it cool naturally to 25°C to obtain a transparent luteolin glycyrrhizic acid supramolecular hydrogel.

[0049] The resulting gel is transparent, uniform in texture, free of visible particles, and exhibits good flowability and spreadability. Figure 2 As shown, Figure 2 These are photographs of glycyrrhizic acid / luteolin supramolecular hydrogels formed at different pH values ​​and concentration ratios. The sample corresponding to the parameters of this embodiment (pH=5, 1 mg / ml luteolin, 10 mg / ml glycyrrhizic acid) shows the best transparency and integrity, confirming the excellent self-assembly effect at this ratio.

[0050] This embodiment successfully prepared a carrier-free supramolecular hydrogel, verifying that under optimal concentration and pH conditions, luteolin and glycyrrhizic acid can form a stable three-dimensional network structure through non-covalent interactions.

[0051] Example 2 This embodiment aims to verify the effect of the lower limit of luteolin concentration on gel formation.

[0052] The method is the same as in Example 1, except that the amount of luteolin in step (1) is adjusted so that its final concentration in the gel composition is 0.5 mg / ml, and the other preparation conditions (glycyrrhizic acid concentration 10 mg / ml, NaOH concentration 1 mol / L, heating temperature 80°C, pH adjustment 5, cooling temperature 25°C) are completely consistent with those in Example 1.

[0053] The resulting product is still a transparent gel, but its viscosity is slightly lower than that of Example 1, while still maintaining good formability.

[0054] The results showed that the technique could still achieve gelation even at a luteolin concentration as low as 0.5 mg / ml, demonstrating the feasibility of the defined lower concentration limit.

[0055] Example 3 This embodiment aims to verify the effect of the upper limit of luteolin concentration on gel formation.

[0056] The method is the same as in Example 1, except that the amount of luteolin in step (1) is adjusted so that its final concentration in the gel composition is 2 mg / ml, and the other preparation conditions are completely consistent with those in Example 1.

[0057] The product obtained was a transparent gel with increased viscosity compared to Example 1, and no precipitation or stratification was observed.

[0058] The results showed that the system could still form a stable gel at a concentration of luteolin as high as 2 mg / ml, proving that the upper limit of the specified concentration was feasible.

[0059] Example 4 This embodiment aims to verify the effect of the lower limit of glycyrrhizic acid concentration on gel formation.

[0060] The method is the same as in Example 1, except that the amount of glycyrrhizic acid in step (2) is adjusted so that its final concentration in the gel composition is 5 mg / ml, while the other preparation conditions (luteolin concentration 1 mg / ml, etc.) are completely consistent with those in Example 1.

[0061] The resulting product is a transparent gel with slightly lower mechanical strength than in Example 1, but it still retains the complete gel morphology.

[0062] The results show that the technical solution of this application remains effective at a glycyrrhizic acid concentration of 5 mg / ml, supporting the lower limit of the glycyrrhizic acid concentration range.

[0063] Example 5 This embodiment aims to verify the effect of the upper limit of glycyrrhizic acid concentration on gel formation.

[0064] The method is the same as in Example 1, except that the amount of glycyrrhizic acid in step (2) is adjusted so that its final concentration in the gel composition is 20 mg / ml, and the other preparation conditions are completely consistent with those in Example 1.

[0065] The obtained product was a transparent gel with a relatively thick texture, and no precipitation was observed.

[0066] The results showed that the system could still gel successfully at a glycyrrhizic acid concentration of 20 mg / ml, supporting the upper limit of the glycyrrhizic acid concentration range.

[0067] Example 6 This embodiment aims to verify the effect of the lower pH limit on gel properties.

[0068] The method is the same as in Example 1, except that in step (4), the pH value of the acidic mixed solution is adjusted to 4, and the rest of the preparation conditions are completely consistent with those in Example 1.

[0069] The resulting gel had good transparency, but its strength was slightly weaker than that of the sample at pH=5.

[0070] The results showed that luteolin and glycyrrhizic acid could still self-assemble to form a gel at pH=4, verifying the effectiveness of the pH range of the acidic mixed solution.

[0071] Example 7 This embodiment aims to verify the effect of the upper limit of pH value on gel performance.

[0072] The method is the same as in Example 1, except that the pH of the acidic mixed solution is adjusted to 5 in step (4).

[0073] Correction: Refer to the method of Example 1, except that in step (4), the pH value of the acidic mixed solution is adjusted to 4.9, and the other preparation conditions are completely consistent with those of Example 1.

[0074] The prepared gel exhibited properties similar to the sample at pH=5, with good transparency.

[0075] The results indicate that gel formation is stable within a pH range close to 5, supporting the pH range limitation of the acidic mixed solution.

[0076] Example 8 This embodiment aims to verify the effect of cooling temperature on gel formation.

[0077] The method is the same as in Example 1, except that in step (4), the acidic mixed solution is cooled to 20°C, and the other preparation conditions are completely consistent with those in Example 1.

[0078] The resulting gel had a uniform texture with no significant differences.

[0079] The results show that the method of this application can still successfully obtain the target gel under cooling conditions of 20℃, verifying the feasibility of the cooling temperature range of the acidic mixed solution.

[0080] Example 9 This embodiment aims to verify the effect of the upper limit of cooling temperature on gel formation.

[0081] The method is the same as in Example 1, except that in step (4), the acidic mixed solution is cooled to 30°C, while the other preparation conditions are completely consistent with those in Example 1.

[0082] The gel was obtained and formed well.

[0083] The results show that the gelation process was still successfully completed under cooling conditions of 30℃, further supporting the temperature range of the acidic mixed solution.

[0084] Example 10 This embodiment aims to evaluate the efficacy of the luteolin-glycyrrhizic acid supramolecular hydrogel prepared in this application for the treatment of psoriasis.

[0085] (1) Laboratory animals and grouping Six- to eight-week-old female Balb / c mice were selected and, after one week of acclimatization, were randomly divided into six groups of six mice each. Control group: The skin was treated with physiological saline; Model group: Psoriasis was induced by applying 62.5 mg of 5% imiquimod cream to the epidermis, followed by applying saline solution after 6-8 hours. Positive drug group: 62.5 mg of 5% imiquimod cream was applied to the epidermis to induce psoriasis, followed by calcipotriol ointment after 6-8 hours; Luteolin group: 62.5 mg of 5% imiquimod cream was applied to the epidermis to induce psoriasis, and 1 mg / ml luteolin solution was applied after 6-8 hours. Glycyrrhizic acid group: 62.5 mg of 5% imiquimod cream was applied to the epidermis to induce psoriasis, and 10 mg / ml glycyrrhizic acid solution was applied after 6-8 hours. Gel treatment group: 62.5 mg of 5% imiquimod cream was applied to the epidermis to induce psoriasis. After an interval of 6-8 hours, the luteolin-glycyrrhizic acid supramolecular hydrogel (containing 1 mg / ml luteolin and 10 mg / ml glycyrrhizic acid) prepared in Example 1 was applied.

[0086] The experimental operation procedure is as follows: Figure 3 As shown, Figure 3 This is a timeline diagram illustrating the establishment and treatment experiment of the imimod-induced psoriasis mouse model. The diagram details the complete time sequence from shaving, modeling, drug administration to sample collection and testing, ensuring the standardization of the experimental design.

[0087] (2) Administration and observation The mice were given the drug for 7 consecutive days, and their skin lesions on the back, weight changes, and mental state were observed daily.

[0088] (3) Results Analysis ① Macroscopic observation of skin lesions After 7 days of treatment, the improvement of skin lesions on the backs of mice in each group was as follows: Figure 4 As shown. Figure 4 As shown, Figure 4 These are comparative photos of the improvement of skin lesions on the backs of psoriatic mice in different treatment groups. As can be seen from the pictures, the model group mice showed obvious erythema, thickening and a large amount of silvery-white scales on the backs of their mice; the positive drug group and the gel treatment group mice showed a significant reduction in erythema and scales, and the skin thickness was significantly thinner, with a better degree of recovery than the single-component groups (luteolin group and glycyrrhizic acid group). This indicates that luteolin and glycyrrhizic acid played a significant synergistic therapeutic role in the gel system.

[0089] ②Statistics on weight changes Table 1 shows the changes in body weight of mice in each group during treatment, and the trends are as follows: Figure 5 As shown.

[0090] Table 1. Statistics on changes in body weight of mice in different treatment groups (g, (n=6)

[0091] like Figure 5 As shown, Figure 5 The graph shows the effect of different treatment groups on the weight changes of psoriatic mice. The results indicate that the mice in the model group experienced a significant weight loss due to severe psoriasis, while the weight gain trend of the mice in the gel treatment group was similar to that of the positive drug group and significantly better than that of the single-component group. This suggests that the gel of the present invention can not only effectively treat skin lesions, but also improve the systemic wasting state caused by the disease, and has no obvious toxic side effects.

[0092] ③PASI score statistics Table 2 shows the PASI scores of mice before and after treatment in each group. The trend of score changes is as follows: Figure 6 As shown.

[0093] Table 2. PASI scores of mice in different treatment groups (points, (n=6)

[0094] like Figure 6 As shown, Figure 6 This is a line graph showing the effect of different treatment groups on the PASI score of psoriatic mice. The graph clearly shows that as treatment time progressed, the gel treatment group experienced the largest decrease in PASI score, ultimately scoring significantly lower than the single-component group and even slightly better than the positive control group. This confirms that luteolin and glycyrrhizic acid produced an unexpected synergistic effect in a carrier-free supramolecular gel system, with their anti-inflammatory and inhibitory effects on excessive keratinocyte proliferation far exceeding those of simple single-drug superposition.

[0095] (4) Conclusion Based on the aforementioned macroscopic photographs, body weight data, and PASI score results, the luteolin-glycyrrhizic acid supramolecular hydrogel prepared in this invention exhibits excellent therapeutic effects in an imiquimod-induced psoriasis mouse model. Experimental results show that the luteolin-glycyrrhizic acid supramolecular hydrogel prepared in this invention demonstrates good anti-inflammatory, anti-proliferative, and skin barrier repair effects in psoriasis animal models, and therefore can be used to prepare drugs for the prevention and / or treatment of psoriasis. This gel not only overcomes the shortcomings of existing formulations, such as poor efficacy and high irritation, but also achieves synergistic effects of two drugs through a carrier-free design, showing significant clinical application prospects.

[0096] The above description is merely a preferred exemplary embodiment of this application and is not intended to limit the implementation of this application. Those skilled in the art can easily make corresponding modifications or alterations based on the main concept and spirit of this application. Therefore, the scope of protection of this application should be determined by the scope of protection claimed in the claims.

Claims

1. A gel composition, characterized in that, The gel composition comprises luteolin and glycyrrhizic acid; the concentration of luteolin in the gel composition is from 0.5 mg / ml to 2 mg / ml, and the concentration of glycyrrhizic acid in the gel composition is from 5 mg / ml to 20 mg / ml.

2. The gel composition according to claim 1, characterized in that, The concentration of luteolin in the gel composition is 1 mg / ml, and the concentration of glycyrrhizic acid in the gel composition is 10 mg / ml.

3. The use of the gel composition according to claim 1 or 2 in the preparation of a medicament for treating psoriasis.

4. A method for preparing a gel for treating psoriasis, characterized in that, include: Luteolin was dissolved in water, and sodium hydroxide solution was added to the resulting luteolin aqueous solution until the luteolin aqueous solution became transparent, resulting in a luteolin solution with a concentration of 0.5 mg / ml to 2 mg / ml. Glycyrrhizic acid was dissolved in water, and the resulting aqueous solution of glycyrrhizic acid was heated until it became transparent, yielding a glycyrrhizic acid solution with a concentration of 5 mg / ml to 20 mg / ml. The luteolin solution and the glycyrrhizic acid solution are mixed, and the resulting mixture is heated until a transparent mixture is obtained; Hydrochloric acid solution is added to the transparent mixed solution to adjust the acidity of the solution, and the resulting acidic mixed solution is cooled to obtain a gel for treating psoriasis.

5. The preparation method according to claim 4, characterized in that, The concentration of the luteolin solution is 1 mg / ml, and the concentration of the glycyrrhizic acid solution is 10 mg / ml.

6. The preparation method according to claim 4, characterized in that, The sodium hydroxide solution has a sodium hydroxide concentration of 1 mol / L; the hydrochloric acid solution has a hydrochloric acid concentration of 1 mol / L.

7. The preparation method according to claim 4, characterized in that, The pH value of the acidic mixed solution is 4 to 5.

8. The preparation method according to claim 7, characterized in that, The pH value of the acidic mixed solution is 5.

9. The preparation method according to claim 4, characterized in that, The cooling process involves cooling the acidic mixed solution to 20°C to 30°C.

10. The preparation method according to any one of claims 4 to 9, characterized in that, The heating temperature of the glycyrrhizic acid aqueous solution is 80°C; the heating temperature of the mixed solution is 80°C.

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