Compound oral gargle composition and preparation method thereof

Abstract

The invention discloses a compound oral gargle composition and a preparation method thereof, and relates to the technical field of oral gargle. The compound oral gargle composition comprises the following components: a compound active component, a mucous membrane repairing agent, an anti-inflammatory synergist, a humectant, a solubilizer, a flavoring agent, a pH regulator and water, the content sum of the components is 100 wt%, the compound active component is povidone iodine and tinidazole, and the mucous membrane repairing agent is at least one of chitosan, zinc hyaluronate and silk fibroin. Through the synergistic effect of the composite active ingredients and the mucous membrane repairing agent, the curative effect is improved, the oral environment can be effectively improved, and the effects of diminishing inflammation, repairing mucous membranes and the like are achieved.

Description

Technical Field

[0001] The present invention relates to the technical field of oral rinses and associated medical devices, and in particular to a compound oral rinse composition and a preparation method thereof. Background Art

[0002] Oral diseases are common health issues affecting humans, including gingivitis, periodontitis, oral ulcers, and pericoronitis. These conditions not only cause discomfort, such as pain, swelling, and bad breath, but can also affect normal functions like eating and speaking. In severe cases, they can even impact overall health. The oral cavity harbors a complex microbial community, where pathogens such as bacteria and fungi thrive under favorable conditions, making them a key factor in the development of oral diseases. Currently, a wide variety of oral rinses are available on the market for treating oral diseases. However, existing oral rinses have significant deficiencies in terms of active ingredient synergy, mucosal repair function, and stability control: 1) Single active ingredient: Most commercially available mouthwashes use a single antibacterial ingredient (such as chlorhexidine, povidone iodine, tinidazole, etc.), which has limited efficacy against complex oral infections (such as mixed anaerobic and fungal infections) and can easily lead to drug resistance with long-term use; 2) Mucosal repair is lacking: Pathological conditions such as chemotherapy-induced oral mucositis and oral ulcers require synergistic repair ingredients, but traditional mouthwashes (such as sodium borate solutions) only provide basic cleansing functions and lack repair capabilities; 3) Ethanol dependence: Most mouthwashes require 15wt%-27wt% ethanol to dissolve fat-soluble ingredients, resulting in strong oral irritation and unsuitable for patients with mucosal injuries. Summary of the Invention

[0003] The present invention provides a compound oral rinse composition and a preparation method thereof, which are used to solve multiple technical problems in the prior art, such as poor synergy of active ingredients, mucosal repair function and stability.

[0004] The technical solution adopted in the present invention is as follows: A compound oral rinse composition, characterized in that it comprises the following components: a composite active ingredient, a mucosal repair agent, an anti-inflammatory synergist, a humectant, a solubilizer, a flavoring agent, a pH regulator, and water, wherein the sum of the contents of each component is 100wt%, the composite active ingredient is povidone iodine and tinidazole, and the mucosal repair agent is at least one of chitosan, zinc hyaluronate, and silk fibroin.

[0005] Preferably, the content of povidone iodine in the composition is 0.4 wt % to 1 wt %, and the content of tinidazole is 0.2 wt % to 1 wt %.

[0006] Preferably, the content of chitosan in the composition is 0 or 0.1 wt% to 1 wt%, the content of zinc hyaluronate is 0 or 0.01 wt% to 1 wt%, and the content of silk fibroin is 0 or 0.1 wt% to 1 wt%.

[0007] Preferably, the anti-inflammatory synergist is at least one of the plant extracts baicalin, paeonol, zinc acetylsalicylate, flunixin meglumine, dipotassium glycyrrhizate, thymopentin, tripeptide-1 copper, and liposomal curcumin, accounting for 0.01wt% to 0.3wt% of the composition.

[0008] Preferably, the humectant is one or more of glycerol, propylene glycol, sorbitol, and trehalose, accounting for 1 wt% to 5 wt% of the composition.

[0009] Preferably, the solubilizer is one or more of PEG 200, PEG 300, PEG 400, and PEG 600, accounting for 0.3 wt% to 1.5 wt% of the composition.

[0010] Preferably, the flavoring agent is any one of xylitol, erythritol, and isomalt, accounting for 0.5 wt % to 4 wt % of the composition.

[0011] Preferably, the pH adjuster is any one of a citric acid-sodium citrate buffer system, an acetic acid-sodium acetate buffer system, and a lactic acid-sodium lactate buffer system, accounting for 0.1 wt% to 1 wt% of the composition, and the pH adjuster adjusts the pH value of the composition to 5.5-6.5.

[0012] The method for preparing the composition described in any of the above schemes comprises the following steps: (1) Pre-dissolution in the dark: First, add the solubilizer, flavoring agent, and moisturizer to water and stir to dissolve, then add the anti-inflammatory synergist and dissolve with ultrasound to obtain a solubilized phase; in a dark environment, add the composite active ingredient to water and stir to dissolve, then filter through a PVDF pre-filter to obtain an active ingredient solution; in a dark environment, cool the solubilized phase to 25°C and slowly add the active ingredient solution to maintain a pH of 5.5–5.8 to obtain the main solution system; (2) Mixing and volume adjustment: In a light-proof environment, add the mucosal repair agent dropwise to the main solution system, add the pH adjuster to the above mixed solution, and adjust the solution pH to 5.8±0.1; (3) In a light-proof environment, the above-mentioned composite liquid is subjected to multi-stage sterilization filtration, and then aseptically filled and sterilized. The filtrate is filled into a light-proof and heat-insulated liquid storage unit, and then nitrogen is filled and sealed.

[0013] In summary, compared with the prior art, the present invention has the following advantages and beneficial effects: 1. The present invention improves the therapeutic effect through the synergistic effect of the composite active ingredients and the mucosal repair agent, which can effectively improve the oral environment, play the role of anti-inflammatory and mucosal repair; 2. The present invention adopts step-by-step dissolution, first adding solubilizing, moisturizing, and anti-inflammatory ingredients, and then adding active ingredients, and adding povidone iodine in a dark place to avoid photolysis. The added solubilizing agent solves the precipitation of tinidazole, thereby effectively solving the problem of poor stability of the prior art. 3. The present invention effectively avoids the irritation of the mucosa by the high concentration of ethanol in traditional mouthwashes by using a mild solubilizing ingredient; the pH buffer system simulates the physiological environment of the oral cavity, avoids the large pH fluctuations of traditional mouthwashes, and further reduces mucosal irritation. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] Figure 1 This is a flow chart of the preparation process of the compound oral rinse composition provided by the present invention. DETAILED DESCRIPTION

[0015] The present invention will be described in detail below in conjunction with specific embodiments and examples, and the advantages and various effects of the present invention will be more clearly presented. It should be understood by those skilled in the art that these specific embodiments and examples are for illustrating the present invention, rather than for limiting the present invention.

[0016] Throughout this specification, unless otherwise specified, the terms used herein should be understood to have the meaning commonly used in the art. Therefore, unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. In the event of any conflict, the present specification shall take precedence.

[0017] Unless otherwise specified, various raw materials, reagents, instruments and equipment used in the present invention can be purchased from the market or prepared by existing methods.

[0018] Example 1 The compound oral rinse composition provided in this embodiment has a formula as shown in Table 1; Table 1 Formula ratio of compound oral rinse composition 1

[0019] Its preparation process is as follows Figure 1 As shown, the specific preparation steps are as follows: S1. Predissolution (protect from light): Add PEG 400, xylitol, and glycerol to 40°C water for injection and stir to dissolve. Add baicalin and sonicate for 20 minutes (power 300W). Separately, dissolve povidone iodine and tinidazole in 25°C water for injection, stir in the dark, and filter through a 0.45 μm PVDF membrane. Cool the solubilized phase to 25°C and slowly add the active ingredient solution to maintain a pH of 5.6 ± 0.1.

[0020] S2. Mixing and adjusting the volume: Add zinc hyaluronate to the main solution and stir at 200 rpm for 30 min; add citric acid-sodium citrate buffer and adjust the pH to 5.8±0.1.

[0021] S3. Sterilization and filling: filter through two stages of 0.22μm PES membrane in sequence, fill into the liquid storage unit of the quantitative injection device (medical PP liner, 40ml), and seal with nitrogen.

[0022] Example 2 The compound oral rinse composition provided in this embodiment has a formula as shown in Table 2; Table 2 Formula ratio of compound oral rinse composition 2

[0023] Its preparation process is as follows Figure 1 As shown, the specific preparation steps are as follows: S1. Predissolution (protect from light): Add PEG 400, xylitol, and glycerol to 40°C water for injection and stir to dissolve. Add baicalin and sonicate for 20 minutes (power 300W). Separately, dissolve povidone iodine and tinidazole in 25°C water for injection, stir in the dark, and filter through a 0.45 μm PVDF membrane. Cool the solubilized phase to 25°C and slowly add the active ingredient solution to maintain a pH of 5.6 ± 0.1.

[0024] S2. Mixing and adjusting to volume: Add citric acid-sodium citrate buffer and adjust the pH to 5.8±0.1.

[0025] S3. Sterilization and filling: filter through two stages of 0.22μm PES membrane in sequence, fill into the liquid storage unit of the quantitative injection device (medical PP liner, 40ml), and seal with nitrogen.

[0026] Example 3 The compound oral rinse composition provided in this embodiment has a formula as shown in Table 3; Table 3 Formula ratio of compound oral rinse composition 3

[0027] Its preparation process is as follows Figure 1 As shown, the specific preparation steps are as follows: S1. Predissolution (protect from light): Add PEG 400, xylitol, and glycerol to 40°C water for injection and stir to dissolve. Add baicalin and sonicate for 20 minutes (power 300W). Separately, dissolve povidone iodine in 25°C water for injection, protect from light, and stir. Pass the solution through a 0.45 μm PVDF membrane. Cool the solubilized phase to 25°C and slowly add the active ingredient solution to maintain a pH of 5.6 ± 0.1.

[0028] S2. Mixing and adjusting the volume: Add zinc hyaluronate to the main solution and stir at 200 rpm for 30 min; add citric acid-sodium citrate buffer and adjust the pH to 5.8±0.1.

[0029] S3. Sterilization and filling: filter through two stages of 0.22μm PES membrane in sequence, fill into the liquid storage unit of the quantitative injection device (medical PP liner, 40ml), and seal with nitrogen.

[0030] Example 4 The compound oral rinse composition provided in this embodiment has a formula as shown in Table 4; Table 4 Formula ratio of compound oral rinse composition 4

[0031] Its preparation process is as follows Figure 1 As shown, the specific preparation steps are as follows: S1. Predissolution (protect from light): Add PEG 400, xylitol, and glycerol to 40°C water for injection and stir to dissolve. Add baicalin and sonicate for 20 minutes (power 300W). Separately, dissolve tinidazole in 25°C water for injection, protect from light, and stir. Pass the mixture through a 0.45 μm PVDF membrane. Cool the solubilized phase to 25°C and slowly add the active ingredient solution to maintain a pH of 5.6 ± 0.1.

[0032] S2. Mixing and adjusting the volume: Add zinc hyaluronate to the main solution and stir at 200 rpm for 30 min; add citric acid-sodium citrate buffer and adjust the pH to 5.8±0.1.

[0033] S3. Sterilization and filling: filter through two stages of 0.22μm PES membrane in sequence, fill into the liquid storage unit of the quantitative injection device (medical PP liner, 40ml), and seal with nitrogen.

[0034] Example 5 The compound oral rinse composition provided in this embodiment has the same formula as that of Example 1; The preparation method comprises the following steps: mixing and dissolving the composite active ingredient, a mucosal repair agent, an anti-inflammatory synergist, a moisturizer, a solubilizer, a flavoring agent, a pH regulator and water to obtain a composition 5.

[0035] Example 6

[0036] The compound oral rinse composition provided in this embodiment has a formula as shown in Table 5; Table 5 Formula ratio of compound oral rinse composition 6

[0037] Its preparation process is as follows Figure 1As shown, the specific preparation steps are as follows: S1. Predissolution (protect from light): Add PEG 400, xylitol, and glycerol to 40°C water for injection and stir to dissolve. Add baicalin and sonicate for 20 minutes (power 300W). Separately, dissolve povidone iodine and tinidazole in 25°C water for injection, stir in the dark, and filter through a 0.45 μm PVDF membrane. Cool the solubilized phase to 25°C and slowly add the active ingredient solution to maintain a pH of 5.6 ± 0.1.

[0038] S2. Mixing and volume adjustment: chitosan was added to the main solution and stirred at 200 rpm for 30 min; citric acid-sodium citrate buffer was added and the pH was adjusted to 5.8±0.1.

[0039] S3. Sterilization and filling: filter through two stages of 0.22μm PES membrane in sequence, fill into the liquid storage unit of the quantitative injection device (medical PP liner, 40ml), and seal with nitrogen.

[0040] Example 7 The compound oral rinse composition provided in this embodiment has a formula as shown in Table 6; Table 6 Formula ratio of compound oral rinse composition 7

[0041] Its preparation process is as follows Figure 1 As shown, the specific preparation steps are as follows: S1. Predissolution (protect from light): Add PEG 400, xylitol, and glycerol to 40°C water for injection and stir to dissolve. Add baicalin and sonicate for 20 minutes (power 300W). Separately, dissolve povidone iodine and tinidazole in 25°C water for injection, stir in the dark, and filter through a 0.45 μm PVDF membrane. Cool the solubilized phase to 25°C and slowly add the active ingredient solution to maintain a pH of 5.6 ± 0.1.

[0042] S2. Mixing and volume adjustment: Add silk fibroin to the main solution and stir at 200 rpm for 30 min; add citric acid-sodium citrate buffer and adjust the pH to 5.8±0.1.

[0043] S3. Sterilization and filling: filter through two stages of 0.22μm PES membrane in sequence, fill into the liquid storage unit of the quantitative injection device (medical PP liner, 40ml), and seal with nitrogen.

[0044] Example 8 The compound oral rinse composition provided in this embodiment has a formula based on that of Example 1, except that zinc hyaluronate is replaced with chitosan, zinc hyaluronate, and silk fibroin in equal proportions by mass.

[0045] The compound oral rinse composition provided in this embodiment has a formula as shown in Table 7; Table 7 Formula ratio of compound oral rinse composition 8

[0046] Its preparation process is as follows Figure 1 As shown, the specific preparation steps are as follows: S1. Predissolution (protect from light): Add PEG 400, xylitol, and glycerol to 40°C water for injection and stir to dissolve. Add baicalin and sonicate for 20 minutes (power 300W). Separately, dissolve povidone iodine and tinidazole in 25°C water for injection, stir in the dark, and filter through a 0.45 μm PVDF membrane. Cool the solubilized phase to 25°C and slowly add the active ingredient solution to maintain a pH of 5.6 ± 0.1.

[0047] S2. Mixing and volume adjustment: Add zinc hyaluronate, silk fibroin, and chitosan to the main solution and stir at 200 rpm for 30 min; add citric acid-sodium citrate buffer and adjust the pH to 5.8±0.1.

[0048] S3. Sterilization and filling: filter through two stages of 0.22μm PES membrane in sequence, fill into the liquid storage unit of the quantitative injection device (medical PP liner, 40ml), and seal with nitrogen.

[0049] Test performance 1. In vitro antibacterial efficacy test The antibacterial activity of the compound oral rinses was evaluated by measuring the minimum inhibitory concentration (MIC) and inhibition zone diameter of different sample concentrations against Porphyromonas gingivalis and Staphylococcus aureus using the two-fold agar plate dilution method. In the experiment, the bacterial solution and the mouthwash at different concentrations were diluted, spread on agar plates, and incubated in a constant temperature incubator. Bacterial growth was observed, and the lowest drug concentration that resulted in no bacterial growth was defined as the MIC. Furthermore, the antibacterial efficacy and synergistic effects of the different formulations were compared by measuring the inhibition zone diameters, thereby comprehensively evaluating their in vitro antibacterial activity.

[0050] Table 8 In vitro antibacterial efficacy test results

[0051] As can be seen from the test results in Table 8, the composite active ingredients (povidone iodine and tinidazole) of Example 1 provide the core antibacterial effect, while zinc hyaluronate acts as a mucosal repair agent to enhance the synergistic antibacterial and diffusion effects. Preparation processes such as ultrasound and filtration ensure uniform dissolution and stability of the ingredients, thereby exhibiting optimal antibacterial efficacy.

[0052] The MIC of Example 2 was slightly higher than that of Example 1, but the zone of inhibition was significantly reduced (by approximately 22%). The absence of zinc hyaluronate reduced mucosal repair and antibacterial synergy, leading to a weakened antibacterial diffusion capacity (reduced zone of inhibition), but the core active ingredients (povidone-iodine and tinidazole) still maintained basic antibacterial efficacy (small change in MIC).

[0053] The MIC of Example 3 was significantly increased (by 55% compared to Example 1), and the zone of inhibition was reduced. Tinidazole is a key active ingredient in the compound, and its absence disrupts the synergistic antibacterial mechanism with povidone-iodine, resulting in a decrease in overall antibacterial efficacy, particularly against P. gingivalis (where the MIC increased significantly), and a weakened diffusion capacity.

[0054] Example 4 showed a higher MIC (61% increase compared to Example 1) and a smaller zone of inhibition. Povidone-iodine is a broad-spectrum antibacterial agent; its absence weakened its inhibition against Staphylococcus aureus (reduced zone of inhibition) and lost its synergistic effect with tinidazole, significantly reducing overall antibacterial efficacy. This, similar to Example 3, highlights the necessity of a combination of active ingredients.

[0055] Example 5 has the same formulation as Example 1, but the simplified process (direct miscibility) omits key steps like light protection, sonication, and filtration. This may result in incomplete dissolution or degradation of active ingredients (such as povidone-iodine and tinidazole). Consequently, antimicrobial efficacy is significantly reduced: the MIC rises to 15.5 μg / mL (due to low drug solubility, requiring higher concentrations for bacterial inhibition), and the inhibition zone decreases to 17.0 mm (due to uneven distribution of ingredients, resulting in reduced antimicrobial activity). This is even worse than Example 4, indicating that the overall quality is more affected by the process than by the absence of a single ingredient.

[0056] In Example 6, chitosan, as a mucosal repair agent, exhibits inherent antibacterial properties (particularly against Gram-positive bacteria such as Staphylococcus aureus). Compared to Example 3, the MIC was 8.4 μg / mL (slightly higher than in Example 1 due to chitosan's weaker effect against P. gingivalis, but still effective against tinidazole and povidone-iodine), and the zone of inhibition was 23.8 mm (significantly higher than 19.0 mm in Example 3 due to chitosan partially replacing the antibacterial synergistic effect of zinc hyaluronate, particularly enhancing inhibition against S. aureus).

[0057] In Example 7, the silk fibroin primarily played a repairing role, with weak antimicrobial properties. Therefore, its efficacy was similar to that of Example 3: the MIC was 8.7 μg / mL (slightly higher than in Example 1 due to the lack of antimicrobial contribution) and the inhibition zone was 19.1 mm (similar to Example 3 due to the lack of additional antimicrobial synergy provided by the silk fibroin).

[0058] The compound of Example 8 (chitosan, zinc hyaluronate, and silk fibroin in equal proportions) combines the antibacterial properties of chitosan with the synergistic restorative effects of zinc hyaluronate. The MIC dropped to 7.9 μg / mL (slightly better than in Example 1, due to the synergistic effect of chitosan and zinc hyaluronate on Porphyromonas gingivalis), and the zone of inhibition increased to 25.0 mm (better than in Example 1, due to the enhanced inhibition of Staphylococcus aureus by chitosan and zinc hyaluronate).

[0059] 2. Evaluation of mucosal repair effect An oral ulcer model was established in healthy SD rats (weighing 200-250 g). Ulcers were induced on the left cheek by burning with 40% glacial acetic acid. The rats were randomly divided into several groups: a control group, a model group, and a mouthwash treatment group. Topical administration of the drug was performed daily for 7 consecutive days after surgery. Experimental materials included the prepared mouthwash (containing mucosal repair components such as zinc hyaluronate), sterile saline, hematoxylin and eosin staining reagents, and reagents for detecting inflammatory factors. The experimental procedures included ulcer area measurement, hematoxylin and eosin staining of tissue sections to observe epithelial regeneration, and expression levels of inflammatory factors (such as interleukin-1α and tumor necrosis factor-α). The ulcer healing time, histological scores, and molecular biological markers were compared among the different treatment groups to evaluate the promoting effect of the mucosal repair components of the mouthwash and its mechanism.

[0060] The test results are shown in Table 9: Table 9 Mucosal repair test results

[0061] As can be seen from Table 9, Example 1 achieves efficient healing of oral ulcers through the triple synergy of "antibacterial-anti-inflammatory-repair". This is because zinc hyaluronate forms a hydrated film to reduce the resistance to epithelial cell migration, while baicalin inhibits inflammatory factors (TNF-α) and reduces microenvironmental interference. Povidone iodine / tinidazole synergistically clears pathogens from the wound, blocks infectious inflammation and prolongs the healing period. Zinc ions activate prolyl hydroxylase and promote collagen cross-linking; tinidazole inhibits bacterial collagenase degradation.

[0062] The results of Example 2 showed that the re-epithelialization rate decreased, the ulcer healing time was prolonged, and the collagen content decreased, indicating that the lack of hydration and lubrication of hyaluronic acid increased the resistance to epithelial cell migration, and zinc deficiency led to a decrease in collagen synthase activity.

[0063] The results of Example 3 showed that the healing time increased by 21.0% (povidone-iodine alone was insufficient). Povidone-iodine is effective against aerobic bacteria, but cannot penetrate anaerobic biofilms. Residual infection leads to repeated inflammation. Tinidazole is an irreplaceable specific antibacterial agent for anaerobic bacteria. Although its absence is better than the group without the repair agent, it is still weaker than the complete formula.

[0064] In Example 4, povidone-iodine (another antibacterial component) was missing, but the mucosal repair agent was intact, resulting in similar efficacy to the tinidazole-deficient group. The reduced antibacterial activity may have affected infection control, with indicators consistent with those in Example 3 (re-epithelialization 110.0 μm² / h, healing 7.5 days), indicating a secondary effect of the active ingredient deletion.

[0065] The formulation of Example 5 is the same as that of Example 1, but the preparation process is simplified (direct miscibility rather than stepwise dissolution). This can lead to aggregation, degradation, or reduced bioavailability of the ingredients (e.g., insufficient ultrasound for baicalin). Consequently, all indicators significantly deteriorated: re-epithelialization rate of 95.0 μm² / h (a 24% decrease compared to intact), healing time of 8.5 days (a 37% increase), and collagen content of 35.0 μg / mg (a 17% decrease). Process optimization is crucial for stability (refer to steps S1-S3 in Example 1).

[0066] In Example 6, chitosan replaced zinc hyaluronate as a mucosal repair agent. Chitosan exhibits bioadhesive properties and promotes healing, but may not be as effective as zinc hyaluronate (referring to the literature showing zinc hyaluronate is superior for oral restorations). Consequently, re-epithelialization was 115.0 μm² / h (an 8% decrease compared to intact), healing time was 6.8 days (a 10% increase), and collagen was 40.0 μg / mg (a slight decrease). These data reflect a slight disadvantage of the alternative restorative agent.

[0067] The silk fibroin in Example 7, as a repair agent, can promote cell migration, but its efficiency may be lower than that of zinc hyaluronate (especially collagen synthesis). Re-epithelialization was 110.0 μm² / h (a 12% decrease compared to intact), healing time was 7.0 days (a 13% increase), and collagen content was 39.0 μg / mg (a 7% decrease). Silk fibroin's effectiveness in oral applications was stable but slightly inferior.

[0068] The combination in Example 8 (chitosan, zinc hyaluronate, and silk fibroin in equal proportions) may synergistically enhance repair through multiple mechanisms (e.g., zinc ions promote collagen formation, chitosan acts as an antibacterial agent, and silk fibroin acts as a barrier). Consequently, the results were slightly better than those in Example 1: re-epithelialization of 135.0 μm² / h (an 8% improvement), healing time of 5.8 days (a 6% reduction), and collagen of 45.0 μg / mg (a 7% increase). These results demonstrate that combination strategies are often effective in improving efficacy.

[0069] Finally, it should be noted that the terms "comprises," "comprising," or any other variations thereof are intended to encompass non-exclusive inclusion, such that a process, method, article, or apparatus that includes a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such process, method, article, or apparatus. Although preferred embodiments of the present invention have been described, additional changes and modifications may be made to these embodiments by those skilled in the art once the basic inventive concepts are known. Therefore, the appended claims are intended to be interpreted as including the preferred embodiments and all changes and modifications that fall within the scope of the invention.

[0070] The above-described embodiments merely represent specific implementation methods of the present application. While the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of protection of the present application. It should be noted that a person skilled in the art could make various modifications and improvements without departing from the technical concept of the present application, and these modifications and improvements are all within the scope of protection of the present application.

Claims

1. A compound oral rinse composition, characterized in that: The invention comprises the following components: a composite active ingredient, a mucosal repair agent, an anti-inflammatory synergist, a moisturizer, a solubilizer, a flavoring agent, a pH regulator, and water, the sum of the contents of each component being 100wt%. The composite active ingredient is povidone iodine and tinidazole, and the mucosal repair agent is at least one of chitosan, zinc hyaluronate, and silk fibroin.

2. The composition according to claim 1, wherein The content of povidone iodine in the composition is 0.4wt%-1wt%, and the content of tinidazole is 0.2wt%-1wt%.

3. The composition according to claim 1, wherein The content of chitosan in the composition is 0 or 0.1wt% to 1wt%, the content of zinc hyaluronate is 0 or 0.01wt% to 1wt%, and the content of silk fibroin is 0 or 0.1wt% to 1wt%.

4. The composition according to claim 1, wherein The anti-inflammatory synergist is at least one of plant extracts selected from baicalin, paeonol, zinc acetylsalicylate, flunixin meglumine, dipotassium glycyrrhizate, thymopentin, tripeptide-1 copper, and liposomal curcumin, accounting for 0.01 wt% to 0.3 wt% of the composition.

5. The composition according to claim 1, wherein The moisturizing agent is one or more of glycerin, propylene glycol, sorbitol, and trehalose, accounting for 1 wt% to 5 wt% of the composition.

6. The composition according to claim 1, wherein The solubilizer is one or more of PEG 200, PEG 300, PEG 400, and PEG 600, accounting for 0.3 wt% to 1.5 wt% of the composition.

7. The composition according to claim 1, wherein The flavoring agent is any one of xylitol, erythritol, and isomalt, accounting for 0.5 wt % to 4 wt % of the composition.

8. The composition according to claim 1, wherein The pH regulator is any one of a citric acid-sodium citrate buffer system, an acetic acid-sodium acetate buffer system, and a lactic acid-sodium lactate buffer system, accounting for 0.1 wt% to 1 wt% of the composition. The pH regulator adjusts the pH value of the composition to 5.5-6.

5.

9. The method for preparing the composition according to any one of claims 1 to 8, wherein: The steps include: (1) Pre-dissolution in the dark: First, add the solubilizer, flavoring agent, and moisturizer to water and stir to dissolve, then add the anti-inflammatory synergist and dissolve with ultrasound to obtain a solubilized phase; in a dark environment, add the composite active ingredient to water and stir to dissolve, then filter through a PVDF pre-filtration membrane to obtain an active ingredient solution; In a dark environment, cool the solubilized phase to 25°C and slowly add the active ingredient solution to maintain the pH at 5.5–5.8 to obtain the main solution system. (2) Mixing and volume adjustment: In a light-proof environment, add the mucosal repair agent dropwise to the main solution system, add the pH adjuster to the above mixed solution, and adjust the solution pH to 5.8±0.1; (3) In a light-proof environment, the above-mentioned composite liquid is subjected to multi-stage sterilization filtration, and then aseptically filled and sterilized. The filtrate is filled into a light-proof and heat-insulated liquid storage unit, and then nitrogen is filled and sealed.

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