Oral film agent for dispelling effects of alcohol and protecting liver and preparation method of oral film agent

Abstract

The invention provides a hangover-alleviating and liver-protecting oral film agent and a preparation method thereof, and belongs to the technical field of medicines. The oral film agent for dispelling effects of alcohol and protecting liver provided by the invention is prepared from the following raw materials in percentage by mass: 0.1-5% of puerarin, 1-10% of dendrobium polysaccharide, 40-60% of starch, 10-30% of a polymer film-forming material, 0.1-5% of a plasticizer, 1-10% of a disintegrating agent, 0.01-1% of a flavoring agent and the balance of deionized water. The film agent achieves the effects of dispelling the effects of alcohol and protecting the liver through the synergistic effect of multiple components, has the advantages of being rapid in effect taking, high in bioavailability, convenient to carry and the like, and animal experiments show that the film agent can remarkably reduce the blood alcohol concentration, improve the liver injury index and improve the antioxidant enzyme activity, and a new solution is provided for dispelling the effects of alcohol and protecting the liver.

Description

Technical Field

[0001] The present invention relates to the technical field of medicine, and in particular to an oral film for relieving alcohol and protecting the liver and a preparation method thereof. Background Art

[0002] The current market for hangover relief and liver protection is showing a rapid growth trend, but problems such as product homogeneity, technical bottlenecks and lack of consumer trust need to be overcome urgently.

[0003] 1. Market status: Diversified development driven by demand

[0004] The market size of liver protection products continues to expand: consumers are shifting from "post-hangover sobering" to "daily maintenance", and demand is surging in scenarios such as late-night recovery and social protection. This is driving product forms to upgrade from traditional tablets and oral liquids to portable and snack-like products, such as the rise of emerging categories such as hangover gummies and oral films.

[0005] Ingredients and technology iteration: Traditional medicine and food have the same origin: ingredients such as Pueraria lobata, Hovenia dulcis, and turmeric dominate the market. For example, Wanglaoji Getai Ming'an beverage is based on Pueraria lobata extract, and Korean hangover products generally add Hovenia dulcis.

[0006] Innovative technology applications: Marine phospholipid delivery systems (such as Fengshi Qingxing) and complex peptide technologies (such as Guangyao Baiyunshan Pueraria Root and Turmeric Complex Peptide) enhance bioavailability, while nanocrystal and enzymatic modification technologies improve the absorption efficiency of active ingredients. Microbial interventions: Probiotics (such as the AKK001 strain) and Lactobacillus plantarum fermented drinks enhance alcohol detoxification and liver protection by regulating intestinal flora.

[0007] Consumer groups are differentiated: Young professionals rely on hangover remedies to relieve the stress of socializing and tend to choose ready-to-eat, attractive products, such as hangover jelly and portable drink bars. Middle-aged and elderly consumers prefer traditional Chinese medicine preparations, such as liver-protecting tablets and liver-nourishing teas, emphasizing ingredient safety and long-term benefits.

[0008] Core deficiency: the dual dilemma of technology and market.

[0009] Single mechanism of action and insufficient synergistic effects: Existing products often focus on a single function, such as alcohol absorption (waxy corn starch) or metabolic stimulation (puerarin), lacking multi-target synergy. For example, silybin can only repair 30% of chemically induced liver damage and has limited effectiveness against alcoholic liver disease. Combination products (such as oral films containing dendrobium polysaccharides and golden taro starch) are still in the laboratory stage.

[0010] Outdated dosage forms and low bioavailability. Limitations of traditional dosage forms: Tablets and capsules have long disintegration times (≥30 minutes), making liquid beverages inconvenient to carry and difficult to meet immediate needs. Ingredient absorption barriers: The bioavailability of fat-soluble ingredients such as curcumin and dihydromyricetin is less than 5%, requiring phospholipid encapsulation and nanoemulsification technologies to enhance efficacy.

[0011] Homogeneous competition and a crisis of trust. Formula similarity: Over 80% of products on the market are based on kudzu root and milk thistle, lacking differentiation and making it difficult for consumers to choose.

[0012] It can be seen that most of the hangover products on the market are in the form of tablets, capsules or oral liquids, which have problems such as slow absorption, inconvenience in carrying, and poor taste. For example, traditional Chinese medicine preparations rely on a large amount of solvent extraction, resulting in low bioavailability of the active ingredients. At the same time, existing hangover products mostly focus on a single mechanism (such as adsorbing alcohol or promoting metabolism) and lack multi-target synergy. For example, although the dihydromyricetin orally disintegrating film agent uses nanocrystal technology to improve its solubility, it does not combine liver-protecting polysaccharide components. In addition, ordinary starch is only used as a filler and its functional modification potential has not been fully utilized.

[0013] This invention addresses the shortcomings of existing technologies by providing an oral film formulation that utilizes multi-component, multi-target synergy, combined with functional starch. This combination of "metabolic acceleration + antioxidant + mucosal protection" achieves a 1+1 > 2 effect through ingredient compounding, achieving the dual benefits of rapid hangover relief and liver and stomach protection. In the future, products demonstrating this "multi-target synergy + personalized intervention + clinical validation" will become mainstream in the market, driving the industry towards scientific and standardized development. Summary of the Invention

[0014] The purpose of the present invention is to provide an oral film for detoxification and liver protection, which can accelerate alcohol metabolism, enhance the liver's detoxification ability, reduce gastric mucosal irritation, and prevent acute drunkenness reaction.

[0015] In order to achieve the above-mentioned object of the invention, the present invention provides the following technical solutions:

[0016] The invention provides an oral film for sobering up and protecting the liver. The film is composed of the following raw materials in percentage by mass: 0.1-5% of puerarin, 1-10% of dendrobium polysaccharide, 40-60% of starch, 10-30% of a polymer film-forming material, 0.1-5% of a plasticizer, 1-10% of a disintegrant, 0.01-1% of a flavoring agent, and the balance being deionized water.

[0017] Preferably, the starch is composed of porous golden taro starch, porous kudzu root starch, porous waxy corn starch and modified corn starch in a mass ratio of 1-2:1-2:1-2:1-2:1-2.

[0018] Preferably, the porous golden taro starch, porous kudzu root starch, and porous waxy corn starch are all porous starches modified by saccharifying enzyme and α-amylase, with a specific surface area of ​​≥20m 2 / g.

[0019] Preferably, the polymer film-forming material is one or more of polyvinyl alcohol, hydroxypropyl methylcellulose and polyvinyl pyrrolidone.

[0020] Preferably, the plasticizer is glycerol or polyethylene glycol.

[0021] Preferably, the disintegrant is sodium carboxymethyl starch or microcrystalline cellulose.

[0022] Preferably, the flavoring agent is xylitol or green tea essence.

[0023] The present invention also provides a method for preparing the alcohol-relieving and liver-protecting oral film, comprising the following steps:

[0024] 1) Puerarin was extracted by macroporous adsorption resin method, and Dendrobium polysaccharide was extracted by ultrasound-assisted method;

[0025] 2) preparing porous golden taro starch, porous kudzu root starch, and porous waxy corn starch by enzymatic hydrolysis;

[0026] 3) dissolving puerarin, dendrobium polysaccharide, porous golden taro starch, porous kudzu root starch, porous waxy corn starch, modified corn starch, polymer film-forming material, plasticizer, disintegrant, and flavoring agent in deionized water to form a uniform gel;

[0027] 4) The glue solution is cast on a polyester film and cut into a film after drying.

[0028] The oral film for alcohol detoxification and liver protection provided by the present invention accelerates alcohol metabolism through puerarin, enhances antioxidant capacity through dendrobium polysaccharides, absorbs and delays alcohol absorption through porous golden taro starch, promotes metabolism and protects mucosa through porous kudzu starch, forms a gel to absorb alcohol and release active ingredients through porous waxy corn starch, and enhances stability through multiple ingredients. It achieves the synergistic effect of "metabolic acceleration + antioxidant + mucosal protection" and can more comprehensively play the role of alcohol detoxification and liver protection than single-function alcohol detoxification products (such as those that can only absorb alcohol or promote metabolism). Animal experiments show that it can significantly reduce blood alcohol concentration (the blood alcohol concentration of the medium-dose group 2 hours after drinking is significantly lower than that of the model group and the positive control group), improve liver damage indicators (ALT and AST levels are close to those of the normal control group) and enhance the activity of antioxidant enzymes (SOD, CAT), while reducing MDA content. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 This is a graph showing the blood alcohol concentration test results for each group in Example 2;

[0030] Figure 2 This is a graph showing the liver injury indicator ALT results for each group in Example 2;

[0031] Figure 3 This is a graph showing the AST results of the liver damage index in each group in Example 2;

[0032] Figure 4 This is the SOD result diagram of each group in Example 2;

[0033] Figure 5 This is the MDA result diagram of each group in Example 2;

[0034] Figure 6 This is the antioxidant index CAT result diagram of each group in Example 3;

[0035] Figure 7 Graph showing the blood alcohol concentration test results for each group in Example 3;

[0036] Figure 8 This is a graph showing the liver injury indicator ALT results for each group in Example 3;

[0037] Figure 9 This is a graph showing the AST results of the liver damage index in each group in Example 3;

[0038] Figure 10 This is the SOD result diagram of each group in Example 3;

[0039] Figure 11 This is the MDA result diagram of each group in Example 3;

[0040] Figure 12 This is the antioxidant index CAT result diagram of each group in Example 3. DETAILED DESCRIPTION

[0041] The technical solutions provided by the present invention are described in detail below with reference to the embodiments, but they should not be construed as limiting the scope of protection of the present invention.

[0042] Puerarin: Accelerates alcohol metabolism by activating alcohol dehydrogenase (ADH) and acetaldehyde dehydrogenase (ALDH), while inhibiting free radical damage to liver cells;

[0043] Dendrobium polysaccharide: Enhances liver antioxidant capacity (increases SOD and CAT activity) and reduces alcohol-induced lipid peroxidation;

[0044] Porous golden taro starch: Golden taro starch is modified by saccharifying enzyme and α-amylase to form a porous structure, which absorbs alcohol molecules and delays their absorption, while promoting metabolism by enhancing ADH / ALDH activity.

[0045] Porous Pueraria starch: Pueraria starch is modified with saccharifying enzymes and α-amylase to form a porous structure that can promote metabolism, protect mucous membranes, and relieve alcohol-induced syndrome symptoms;

[0046] Porous waxy corn starch: Waxy corn starch is modified with saccharifying enzymes and α-amylase to form a porous structure, which can form a gel to absorb alcohol, slowly release active ingredients, and prolong the duration of the hangover effect;

[0047] Modified corn starch (purchased from Shandong Zhongyou Biotechnology Co., Ltd.) can enhance stability through physical adsorption and chemical cross-linking.

[0048] Extraction method of active ingredients

[0049] Puerarin extraction: Using the macroporous adsorption resin method, the kudzu root is crushed and extracted with 40-90% ethanol 2-5 times. After concentration, it is purified by resin column to obtain puerarin with a purity of ≥98%;

[0050] Dendrobium polysaccharide extraction: After the Dendrobium rhizome is crushed, 10 times the volume of deionized water is added, and ultrasonic-assisted extraction (power 200-500W, temperature 40-60°C) is performed 2-3 times. After concentration, the extract is precipitated with ethanol and freeze-dried to obtain the Dendrobium polysaccharide extract.

[0051] Example 1

[0052] 1. Weigh the raw materials (based on 100g of film)

[0053] Puerarin 2g, dendrobium polysaccharide 5g, porous golden taro starch, porous kudzu root starch, porous waxy corn starch and modified corn starch 10g each, polyvinyl alcohol (PVA) 20g, glycerol 3g, sodium carboxymethyl starch (CMS-Na) 8g, xylitol 0.5g, and the balance is deionized water.

[0054] 2. Preparation steps: Mix the above-mentioned puerarin, dendrobium polysaccharide, porous golden taro starch, porous kudzu starch, porous waxy corn starch and modified corn starch with polyvinyl alcohol, sodium carboxymethyl starch, glycerol and xylitol, add deionized water and stir to dissolve, ultrasonically degas, cast on a polyester film, dry at 50°C for 3 hours, and cut into 5 cm × 5 cm films to obtain the finished product.

[0055] The preparation method of puerarin is as follows: 100 g of Pueraria root was ground, then added with 5 times the volume of 70% ethanol. Ultrasonic extraction (power 300 W, 40°C) was performed twice, each time for 1 hour. The combined extracts were concentrated to an extract, and then applied to a macroporous adsorption resin column (AB-8 type) and eluted with 50% ethanol. The eluate was collected and dried under reduced pressure to obtain 2.3 g of puerarin (purity 98.5%).

[0056] Extraction of Dendrobium polysaccharide: 200 g of Dendrobium rhizome was ground and added with 10 times the volume of deionized water. Ultrasonic extraction (power 400 W, 50°C) was performed three times, each for 2 hours. The combined extracts were concentrated to 1 / 5 of the original volume, and precipitated by adding 3 times the volume of 95% ethanol. The precipitate was collected by centrifugation and freeze-dried to obtain 12 g of Dendrobium polysaccharide (purity 85%).

[0057] The preparation methods for the porous golden yam starch, porous kudzu root starch, and porous waxy corn starch are as follows: 50g each of golden yam starch, kudzu root starch, and waxy corn starch are weighed, each added with 500ml of deionized water, and gelatinized at 95°C for 30 minutes. After cooling to 40°C, 0.3g of saccharifying enzyme and 0.3g of α-amylase are added and enzymatic hydrolysis is carried out for 8 hours. 0.5g of glutaric acid is added and cross-linked for 2 hours. The mixture is washed three times with acetone and vacuum dried to obtain 42g each of porous golden yam starch, porous kudzu root starch, and porous waxy corn starch.

[0058] Example 2

[0059] 1. Animal Experiment Design

[0060] Grouping: 60 Kunming mice were randomly divided into 6 groups (10 mice in each group): normal control group (normal saline 2 g / kg), model group (normal saline 2 g / kg), positive control group (Neptune Golden Bottle, 1.5 g / kg), low-dose group (film prepared in Example 1 2 g / kg), medium-dose group (film prepared in Example 1 6 g / kg), and high-dose group (film prepared in Example 1 10 g / kg).

[0061] Administration method: Except for the normal control group, the mice in other groups were gavaged with 56% vol liquor (20 ml / kg) 30 minutes after the drug was administered.

[0062] Detection indicators:

[0063] Blood alcohol concentration: Blood was collected from the eye socket 2 hours after drinking and measured by gas chromatography;

[0064] Liver damage indicators: serum ALT and AST activities were measured 24 hours after alcohol infusion;

[0065] Antioxidant capacity: Detection of SOD, CAT activity and MDA content in liver tissue. Figures 1 to 3 shown.

[0066] Depend on Figure 1 ($$ indicates P < 0.01 compared with the normal group; * indicates P < 0.05, ** indicates P < 0.01 compared with the model group). This indicates that all dose groups of the film had a certain ability to reduce blood alcohol content in a dose-dependent manner. Furthermore, the film prepared in this application demonstrated a superior alcohol-lowering effect compared to the existing drug, Neptune Golden Bottle. Two hours after alcohol administration, the blood alcohol concentration in the medium-dose group decreased to (38.2 ± 8.7) mg / dL, significantly lower than the model group (128.5 ± 15.3) mg / dL (P < 0.01), and superior to the positive control group (68.9 ± 10.2) mg / dL.

[0067] Depend on Figures 2-3($$ indicates P<0.01 compared with the normal group; * indicates P<0.05, ** indicates P<0.01 compared with the model group) It can be seen that the ALT and AST in the medium-dose film group were (35.3±7.2) U / L and (58.6±2.6) U / L, respectively, which were significantly lower than those in the model group (ALT 54.3±8.2 U / L, AST 92.4±9.8 U / L) (P<0.01), and close to the level of the normal control group.

[0068] Depend on Figures 4-6 ($$ indicates P<0.01 compared with the normal group; * indicates P<0.05, ** indicates P<0.01 compared with the model group) It can be seen that the SOD and CAT activities of the liver tissue in the dosage group in Example 1 were (11.3±1.5) U / mg prot and (41.7±2.5) U / mg prot, respectively, which were significantly higher than those in the model group SOD (5.3±1.5 U / mg prot, CAT 21.3±2.4 U / mg prot); the MDA content (1.2±0.1) nmol / mg prot was significantly lower than that in the model group (2.2±0.1) nmol / mg prot (P<0.01).

[0069] Example 3

[0070] Using the preparation method of Example 1, films were prepared after removing puerarin, dendrobium polysaccharide, porous kudzu root starch, porous golden taro starch, porous waxy corn starch, and modified corn starch. The efficacy of each group was compared according to the experimental process of Example 2 using medium doses (i.e., medium dose film group, medium dose film group (without puerarin), medium dose film group (without dendrobium polysaccharide), medium dose film group (without kudzu root starch), medium dose film group (without golden taro starch), medium dose film group (without waxy corn starch), and medium dose film group (without modified starch)). The results are as follows. Figures 7-12 As shown (compared with the medium-dose group of the same film, # indicates P < 0.05, ## indicates P < 0.01).

[0071] Depend on Figures 7-12 It can be seen that after removing any of the above ingredients, the oral film prepared in this application significantly reduces its alcohol-lowering, liver-protecting, and antioxidant effects. This shows that the various ingredients in this application have a synergistic effect, and the interaction between the various ingredients jointly achieves excellent alcohol-resolving, liver-protecting, and antioxidant effects.

[0072] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present invention. These improvements and modifications should also be regarded as within the scope of protection of the present invention.

Claims

1. An oral film for detoxifying alcohol and protecting the liver, characterized in that: The invention is composed of the following raw materials in percentage by mass: 0.1-5% of puerarin, 1-10% of dendrobium polysaccharide, 40-60% of starch, 10-30% of polymer film-forming material, 0.1-5% of plasticizer, 1-10% of disintegrant, 0.01-1% of flavoring agent, and the balance is deionized water.

2. The alcohol-relieving and liver-protecting oral film according to claim 1, characterized in that: The starch is composed of porous golden taro starch, porous kudzu root starch, porous waxy corn starch and modified corn starch in a mass ratio of 1-2:1-2:1-2:1-2.

3. The alcohol-relieving and liver-protecting oral film according to claim 2, characterized in that: The porous golden taro starch, porous kudzu root starch and porous waxy corn starch are all porous starches modified by saccharifying enzyme and α-amylase, with a specific surface area of ​​≥20m 2 / g.

4. The alcohol-relieving and liver-protecting oral film according to claim 3, characterized in that: The polymer film-forming material is one or more of polyvinyl alcohol, hydroxypropyl methylcellulose and polyvinyl pyrrolidone.

5. The alcohol-relieving and liver-protecting oral film according to claim 4, characterized in that: The plasticizer is glycerol or polyethylene glycol.

6. The alcohol-relieving and liver-protecting oral film according to claim 5, characterized in that: The disintegrant is sodium carboxymethyl starch or microcrystalline cellulose.

7. The alcohol-relieving and liver-protecting oral film according to claim 6, characterized in that: The flavoring agent is xylitol or green tea essence.

8. A method for preparing the alcohol-relieving and liver-protecting oral film according to any one of claims 1 to 7, characterized in that: The following steps are involved: 1) Puerarin was extracted by macroporous adsorption resin method, and Dendrobium polysaccharide was extracted by ultrasound-assisted method; 2) preparing porous golden taro starch, porous kudzu root starch, and porous waxy corn starch by enzymatic hydrolysis; 3) dissolving puerarin, dendrobium polysaccharide, porous golden taro starch, porous kudzu root starch, porous waxy corn starch, modified corn starch, polymer film-forming material, plasticizer, disintegrant, and flavoring agent in deionized water to form a uniform gel; 4) The glue solution is cast on a polyester film and cut into a film after drying.

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