Film-forming agent composition, lobed kudzuvine root-containing film candy as well as preparation method and application of lobed kudzuvine root-containing film candy

Abstract

The invention relates to a film-forming agent composition, a lobed kudzuvine root-containing film candy as well as a preparation method and application of the lobed kudzuvine root-containing film candy, and belongs to the technical field of foods. The technical problem to be solved is to improve the problems of large oral liquid volume, inconvenience in carrying, poor taste, poor solubility, low bioavailability, difficulty in taking and the like of the traditional kudzuvine root preparations, such as kudzuvine root oral liquid, kudzuvine root tablets, kudzuvine root capsules and the like, and the invention provides the kudzuvine root-containing diaphragm candy with unique flavor, high dissolution speed and good oral adhesion. According to the key point of the technical scheme, the film-forming agent composition is composed of sodium carboxymethyl cellulose and hydroxypropyl methyl cellulose.

Description

Technical Field

[0001] This invention relates to the field of food technology, specifically to a film-forming agent composition, a film-forming candy containing kudzu root, its preparation method, and its application. Background Technology

[0002] For understanding the technical content of this invention: Kudzu root, a traditional plant used both as food and medicine, has a long history of application in my country. It contains various active ingredients such as puerarin and daidzein, possessing multiple pharmacological effects including hangover relief, liver protection, improved cardiovascular function, and antioxidant properties, making its application in hangover relief and liver protection widely recognized. However, traditional kudzu root preparations, such as kudzu root oral liquid, tablets, and capsules, have some shortcomings. For example, oral liquids are bulky and inconvenient to carry, and may have a poor taste; tablets and capsules require water to take, which is inconvenient in situations where water is scarce or swallowing is difficult, and can also pose challenges for children, the elderly, or those with swallowing difficulties.

[0003] Film-form candies, as a novel functional ingredient delivery system, have received increasing attention and application in recent years. They are thin-film preparations composed of raw materials and film-forming agents, typically resembling postage stamps in size and shape. Film-form candies possess many unique advantages, such as convenient consumption, flexible dosage, portability, good taste, and high bioavailability. Among these, the film-forming agent is one of the core raw materials determining product quality. The core characteristic of film-form candies is the formation of a continuous, uniform film structure on or inside the candy surface through the film-forming agent. The film-forming agent is crucial in achieving this process, playing a vital role throughout the entire process of film formation, performance maintenance, and the final presentation of product characteristics. The film-forming agent directly affects the candy's taste, shape, and shelf life by regulating the film's mechanical strength, flexibility, and stability. Film-form candies often contain ingredients susceptible to environmental influences (such as vitamins, probiotics, and flavorings), and the film-forming agent provides protection by constructing a "barrier." The taste of film-form candies (such as melt-in-your-mouth texture and smoothness) is largely determined by the film layer characteristics, with the film-forming agent being a key regulatory factor.

[0004] Therefore, given the beneficial pharmacological effects of kudzu root and the unique advantages of membrane candies, developing a kudzu root-containing membrane candy is of great significance. This would not only provide consumers with a more convenient and efficient way to consume kudzu root products, but also further expand the application areas of kudzu root, enrich the variety of membrane candy formulations, and provide more references and practical experience for the application of membrane candy technology in the field of natural medicines.

[0005] Relevant patent documents retrieved: This document, published in China (CN117322500A) on January 2, 2024, discloses a kudzu root compound compressed candy with hangover-relieving and liver-protecting effects, and its preparation method. The kudzu root compound compressed candy is composed of the following components in parts by weight: 8-40 parts kudzu root powder, 8-40 parts blueberry enzyme, 3-12 parts ginseng powder, 2-15 parts goji berry powder, 1-5 parts vitamin C, 2-16 parts xylitol, 1-3 parts citric acid, 10-22 parts microcrystalline cellulose, and 0.1-2.5 parts magnesium stearate. The components in this compressed candy work synergistically to provide excellent hangover-relieving and liver-protecting effects, replenish energy promptly, and quickly eliminate post-drinking discomfort.

[0006] The document, published in China (CN105707397A) on June 29, 2016, discloses a vitamin health candy. This candy combines vitamin A, vitamin D, xylitol, traditional Chinese medicine, and excipients. The raw material formula by weight is as follows: vitamin A 25-50 parts, vitamin D 25-50 parts, kudzu root extract 15-45 parts, glycyrrhizic acid 2-20 parts, propolis powder 5-35 parts, xylitol 20-60 parts, low-substituted hydroxypropyl cellulose 1-10 parts, croscarmellose sodium cellulose 1-10 parts, magnesium stearate 0.5-5 parts, and a coating agent 20-120 parts. The coating agent consists of hydroxypropyl methylcellulose, polyethylene glycol 6000, talc, iron oxide palmitate, and maltitol. This invention uses vitamin A, vitamin D, and xylitol as the main raw materials, which not only greatly improves the health benefits of the candy, but also achieves an auxiliary protective effect against chemically induced liver damage by adding xylitol and some traditional Chinese medicine excipients. It is suitable for diabetic patients, people who want to lose weight, people in a sub-healthy state, the elderly, and children.

[0007] This document, published in China (CN106822054A) on June 13, 2017, discloses a method for preparing an oxiracetam oral film. The film is made from oxiracetam, a film-forming material, a filler, a plasticizer, a sweetener, and a salivary stimulant. The film-forming material comprises maltodextrin and at least one other polymeric film-forming material. This other polymeric film-forming material is selected from one or more combinations of hydroxypropyl cellulose, amylopectin, sodium alginate, pullulan, povidone-vinyl acetate, or sodium carboxymethyl cellulose. This method solves technical problems such as poor mechanical properties, long disintegration time, brittleness, and easy breakage of the film, thereby ensuring product quality.

[0008] Relevant non-patent literature retrieved: The journal *Food Industry* published an article titled "Development and Research of Kudzu Root Hangover Relief Lozenges," Volume 1, dated February 20, 2010. This article discloses the preparation of a lozenge product with hangover relief effects using kudzu root extract and tea polyphenols as the main raw materials. Through taste evaluation and orthogonal experiments, the optimal formula for the lozenges was determined to be: 16g kudzu root extract, 3.5g tea polyphenol extract, 25g sucrose, 5g taurine, 3g vitamin C, 25g mannitol, 3g starch, 10g maltodextrin, 6g glucose, 0.5g magnesium stearate, 1.6g acidulant (1.28g malic acid + 0.32g citric acid), and 0.1g menthol.

[0009] The journal *China Food Additives*, with the article titled "Research and Development Status of the Nutritional and Health Benefits of Kudzu Root at Home and Abroad," Volume 6, published on December 15, 2002, discloses the hypoglycemic, lipid-lowering, and hangover-relieving effects of puerarin. High doses of puerarin can lower blood sugar, but have no effect on adrenaline-induced hyperglycemia; it can also significantly lower serum cholesterol, but has no significant effect on serum free fatty acids and triglycerides. Kudzu root has a papaverine-like antispasmodic effect on isolated intestinal segments of mice and guinea pigs. Kudzu root can effectively antagonize alcohol-induced lipid peroxidation damage to liver and testicular tissues, and is expected to be developed as a reliable hangover remedy. Kudzu root contains daidzein, which can decompose acetaldehyde toxicity, prevent the weakening of brain function due to alcohol's inhibitory effect, inhibit the absorption of alcohol in the gastrointestinal tract, and promote the metabolism and excretion of alcohol in the blood.

[0010] The prior art represented by the aforementioned literature has at least the following unresolved technical problems or defects: (1) Poor solubility, insufficient dispersion of kudzu root powder, and incomplete dissolution of small molecule excipients. The relevant evidence is: Publication No. CN117322500A. In the preparation method of kudzu root compound compressed candy disclosed in this document, in the raw material component mixing stage, kudzu root powder, blueberry enzyme, ginseng powder, wolfberry powder, and powders such as vitamin C, xylitol, citric acid, and microcrystalline cellulose are uniformly mixed according to the weight ratio to obtain premixed powder. Among them, kudzu root powder contains fiber and starch, and water-soluble excipients such as sugar alcohol and sweeteners are directly mixed with kudzu root powder. If the stirring intensity is insufficient, agglomerates are easily formed due to hydrogen bonding, which may result in local crystallization or precipitation (such as xylitol is easy to precipitate in a low humidity environment), resulting in uneven sweetness of tablets or decreased mechanical strength.

[0011] (2) Insufficient product stability. Relevant evidence is provided by CN117322500A, which discloses a method for preparing kudzu compound compressed candy. The compressed tablets are dried in a constant temperature drying oven to obtain kudzu compound compressed candy. The drying temperature is 40-60℃ and the drying time is 1-2h. The kudzu powder in this literature contains starch and fiber and has strong water absorption. If the drying temperature or time is insufficient, the moisture content of the tablets may exceed the standard (>5%), leading to microbial growth or component degradation. In particular, the oven drying method in this literature is prone to uneven temperature distribution, resulting in a large difference in moisture content between the edge and the center of the tablets. For example, the edge may be over-dried while the center is moist, affecting product stability.

[0012] (3) The product has insufficient mechanical strength. The relevant evidence is: CN117322500A, which discloses the preparation method of kudzu compound compressed candy. However, the method does not involve defoaming treatment after mixing the materials. During the compression process, residual air may form internal pores in the tablet, which leads to stress concentration around the pores. The tablet is easy to break during transportation or storage, and the mechanical strength is reduced. At the same time, residual air accelerates the oxidation of components such as puerarin, which increases the risk of oxidation and thus shortens the shelf life of the product. Summary of the Invention

[0013] The purpose of this invention is to provide: A film-forming agent composition, a film-forming candy containing kudzu root, and related technologies, to solve the technical problems of traditional kudzu root preparations such as inconvenience in carrying, poor taste, inconvenient use, poor solubility, and low bioavailability, or a combination thereof.

[0014] Terminology Explanation: Unless otherwise defined, all technical terms in this document have the same meanings as commonly understood by one of ordinary skill in the art to which the subject matter of the claims pertains. Unless otherwise stated, all patents, patent inventions, and publications cited in this document are incorporated herein by reference in their entirety. If multiple definitions exist for terms in this document, the definitions in this chapter shall prevail.

[0015] It should be understood that the above brief description and the following detailed description are exemplary and for illustrative purposes only, and do not limit the subject matter of the invention in any way. In this invention, the singular is used in conjunction with the plural unless otherwise specifically stated. It should also be noted that, unless otherwise stated, the use of “or” or “or” means “and / or”. Furthermore, the use of the term “comprising” and other forms such as “including,” “containing,” and “contains” are not limiting.

[0016] Definitions of standard chemical terms can be found in the references Chinese Pharmacopoeia 2025 edition and Complete Explanation of Pharmacological Terminology.

[0017] Unless otherwise stated, conventional methods within the scope of the art, such as thickness and uniformity measurement, weight difference and unit area weight measurement, moisture content measurement, tensile strength testing, disintegration time testing, and sensory characteristic testing, shall be used.

[0018] Unless specifically defined herein, the use of all commercially available products herein employs standard techniques. For example, it may be carried out using the manufacturer's instructions for use with the kit, or in accordance with methods known in the art or the description of this invention. The techniques and methods described herein can generally be implemented according to conventional methods well known in the art, based on the descriptions in the various summary and more specific documents cited and discussed in this specification.

[0019] The term "kudzu root" as used in this article refers to the dried root of the legume *Pueraria lobata* or *Pueraria thomsonii* (also known as kudzu vine), which has both medicinal and edible properties. Its morphological characteristics include a robust vine, large tuberous roots, abundant fiber (compared to wild kudzu) and high starch content (compared to kudzu vine), resulting in a powdery and glutinous texture. It is mainly distributed in Henan, Hunan, Zhejiang, and Sichuan provinces of China.

[0020] The term "puerarin" as used in this article refers to an isoflavone compound extracted from the dried roots of the legumes Pueraria lobata or Pueraria thomsonii. It is one of the main active ingredients of kudzu root and has clear pharmacological activity and clinical application value.

[0021] The term "daidzein" as used in this article refers to a naturally occurring isoflavone glycoside compound, mainly derived from legumes such as soybean (Glycine max), kudzu (Pueraria lobata), and three-lobed kudzu, and is one of the important active ingredients in these plants.

[0022] The term "film candy" as used in this article refers to a type of candy that is made from sugar (or sugar substitutes) as the main ingredient, with or without added ingredients, and is processed into a film-like shape. It is a type of candy that combines regular shape and convenience.

[0023] The term "hydroxypropyl methylcellulose" as used in this article refers to a semi-synthetic polymer compound obtained by chemical modification of natural cellulose, belonging to the non-ionic cellulose ether derivatives. It possesses multiple properties such as water solubility, film-forming ability, and thickening ability, and is widely used in various fields such as medicine, food, building materials, and cosmetics.

[0024] The term "sodium carboxymethyl cellulose" as used in this article refers to an anionic cellulose ether derivative obtained by chemical modification of natural cellulose. It has the characteristics of good water solubility, strong thickening properties, and high stability, and is one of the most widely used cellulose ethers in the industrial field.

[0025] The term "sugar alcohol" as used in this article refers to a class of polyol compounds produced by the reduction reaction of sugars (such as monosaccharides and disaccharides). These compounds contain multiple hydroxyl groups (-OH) in their molecules and are derivatives of carbohydrates. Because they have a sweet taste similar to sugars and special metabolic characteristics, they are widely used as food additives and functional ingredients.

[0026] The term "sweetener" as used in this article refers to a class of substances that can impart sweetness to food, beverages and other products by stimulating taste receptors to produce a sweet sensation. They are widely used in the food, pharmaceutical, and daily chemical industries. Their core function is to replace or partially replace sugars (such as sucrose) to provide sweetness, while also adjusting the taste of the product, reducing calories, or meeting the needs of specific groups of people.

[0027] The term "plasticizer" as used in this article refers to a substance that can insert itself between polymer molecular chains, reducing intermolecular forces and thus enhancing the material's flexibility, plasticity, and processability, while preventing embrittlement. It is commonly used in plastics (such as adding plasticizers to PVC to make it softer), coatings (to improve the extensibility of coatings), and pharmaceutical films (to regulate the brittleness of films).

[0028] The term "film-forming composition" as used in this article refers to a substance that forms a continuous, uniform thin film on the surface of a substrate through solvent evaporation, chemical reaction, or physical curing. After film formation, it can serve as a protective, adhesive, or functional carrier, such as film-forming agents used in cosmetics for setting makeup (to maintain makeup longevity), film-forming materials in pharmaceutical films (as drug carriers), and film-forming resins in coatings (to isolate the substrate from the external environment).

[0029] The term "purified water" as used in this article refers to water that has undergone deep purification processes such as distillation, reverse osmosis, and ion exchange, resulting in extremely low levels of impurities (such as minerals, microorganisms, and organic matter). Due to its high purity, it is widely used in pharmaceuticals (as a diluent for preparations and as cleaning water), food processing (in high-cleanliness production processes), and laboratory analysis, and must meet specific quality standards (such as those stipulated in the pharmacopoeia).

[0030] The term "vacuum degree" used in this article refers to a physical quantity that characterizes the degree of rarefaction of gas in a vacuum environment. It is usually expressed as a pressure value (units include Pascals, Torr, etc.). The lower the pressure, the higher the vacuum degree. It is commonly used in vacuum drying (to reduce material oxidation), vacuum coating (to reduce impurity interference), vacuum packaging (to extend the shelf life of food), etc. The core principle is to utilize a low-pressure environment to achieve specific process requirements.

[0031] The term "bioavailability" as used in this article refers to the relative amount and rate at which a drug or nutrient is absorbed by the body and enters the systemic circulation after administration via extravascular routes (such as oral or intramuscular injection).

[0032] The term "mixing" as used in this article refers to the process of combining two or more different substances (which may be solid, liquid, gas, or a combination of different states) through physical or mechanical means to form a macroscopically homogeneous or relatively homogeneous dispersion system.

[0033] The term "defoaming" as used in this article refers to the process of removing dissolved or entrained gases (such as air bubbles in liquids or pore gases in solid slurries) from materials using methods such as vacuum, heating, and ultrasound. The aim is to prevent gases from affecting product quality; for example, defoaming in coatings can reduce defects such as pinholes and bubbles in the coating film.

[0034] The term "coating" as used in this article refers to the process of uniformly applying liquid slurry, solution, or molten material to the surface of a substrate through methods such as brushing, spraying, or dipping, followed by subsequent treatments (such as drying and curing) to form a thin film. In pharmaceutical oral films (where the drug is uniformly distributed), the uniformity of the coating directly affects the performance of the final product.

[0035] The term "drying" as used in this article refers to the process of reducing the moisture content of a material by evaporating moisture or volatile solvents through means such as heating, ventilation, or vacuum. Depending on the characteristics of the material, methods such as hot air drying, freeze drying (preserving heat-sensitive components), and vacuum drying (suitable for easily oxidizable materials) can be selected. The purpose is to extend shelf life (such as for food) or to promote material curing (such as coatings drying into a film).

[0036] The term "hangover relief" as used in this article refers to the process of reducing the adverse effects of alcohol on the body (such as headaches and nausea) by promoting alcohol metabolism (e.g., activating alcohol dehydrogenase and aldehyde dehydrogenase) or reducing alcohol absorption (e.g., protecting the gastric mucosa). Common methods include taking hangover relief products containing ingredients such as kudzu root and Japanese raisin tree fruit, or using dietary methods (such as honey water). The core principle is to accelerate the breakdown of alcohol into harmless substances.

[0037] The term "liver protection" as used in this article refers to measures taken to protect the structure and function of liver cells by supplementing the liver with nutrients needed for liver metabolism (such as glutathione and silymarin) or inhibiting the activity of liver-damaging substances, in response to factors that may damage the liver, such as alcohol, drugs, and toxins. It is commonly used by people who drink alcohol or take medication regularly to maintain normal liver metabolic capacity through health supplements or drugs.

[0038] The term "oral adhesion" as used in this article refers to the ability of oral materials (such as oral films and lozenges) to maintain adhesion to the oral mucosa through physical or chemical action after contact. Its strength directly affects the retention time of the material in the oral cavity (e.g., films require sufficient adhesion to ensure adequate drug release), and is influenced by factors such as the material's hydrophilicity and mucosal humidity.

[0039] The term "stirring" as used in this article refers to the operation of mixing multiple substances evenly by means of machinery or manual agitation. Specifically, it refers to the process of creating flow in a container with the help of external forces (such as rotating blades, stirring rods, airflow, etc.) to achieve uniform mixing of solids, liquids, or gases.

[0040] The term "disintegration time" used in this article refers to the time it takes for a solid dosage form (tablets, films, etc.) to completely disintegrate into particles in a simulated gastrointestinal fluid or oral environment (e.g., 37°C, specific medium). It is a key indicator for measuring the release performance of a formulation (e.g., rapid disintegration can accelerate drug absorption), and different formulations have specific standards (e.g., ordinary tablets are usually required to disintegrate within 15 minutes).

[0041] The term "tensile strength test" as used in this article refers to a test in which a material specimen is stretched at a constant speed until it breaks using a tensile testing machine, and the maximum tensile stress (the ratio of the maximum load to the cross-sectional area of ​​the specimen) that it can withstand is determined. This test is used to evaluate the fracture resistance of materials; for example, packaging films need to pass this test to ensure they are not easily damaged during transportation. The unit is usually MPa.

[0042] The term "film thickness testing" as used in this article refers to the test that measures the thickness of a thin film (coating, film agent, etc.) using contact methods (such as micrometers or digital thickness gauges) or non-contact methods (such as laser thickness gauges). Because the uniformity of film thickness directly affects its mechanical properties and barrier properties (e.g., uneven thickness can easily lead to localized damage), it is a crucial quality control step in production.

[0043] The term "physical property testing of membranes" as used in this article refers to a series of tests performed on the physical properties of thin films, including thickness and tensile strength. The purpose is to verify whether the membrane meets the application requirements.

[0044] The term "flexibility" as used in this article refers to the property of a material to resist breakage or damage when subjected to bending, folding, or torsion by external forces. It is usually assessed by repeatedly folding and bending the material to a specific angle (such as 180°) and observing whether cracks appear, in order to avoid breakage during use.

[0045] The term "mechanical properties" used in this article refers to the mechanical characteristics exhibited by a material under external forces, including tensile strength, compressive strength, hardness, and elastic modulus. These properties reflect a material's ability to resist deformation or fracture and are the core basis for material selection.

[0046] The term "backing material" as used in this article refers to the material located on one side of the diaphragm body that serves to support, protect, isolate, or assist in the molding process.

[0047] The term "water-soluble film-forming material solution" as used in this article refers to a uniformly dispersed system with a certain viscosity formed by dissolving a water-soluble film-forming material (a water-soluble polymer with film-forming properties) in water or an aqueous solvent. This system can be dried through processes such as coating and casting to form a thin film. Such solutions are widely used in pharmaceuticals, food (e.g., sheet candies, oral instant films), cosmetics, and packaging. Their core function is to form a thin film with specific properties (such as flexibility, water solubility, and biocompatibility) after the solvent evaporates.

[0048] The term "film-forming solution" as used in this article refers to a dispersion system in which a film-forming material (a substance with film-forming ability, mostly a polymer compound) is dissolved or uniformly dispersed in a solvent, forming a dispersion system with a specific viscosity that can be applied through processes such as coating, casting, and dip coating, and then cured into a thin film after solvent evaporation or chemical reaction. It is a core intermediate product in the preparation of thin film materials and is widely used in packaging, pharmaceuticals, food, electronics, coatings, and other fields.

[0049] The term "sweet solution" as used in this article refers to a homogeneous liquid system with a sweet flavor, formed by dissolving or dispersing sweet substances (components that stimulate the taste buds to produce a sweet sensation) in a solvent. It is widely used in food processing, beverage preparation, and pharmaceutical formulation (to mask bitterness), and its core function is to provide sweetness in liquid form, while allowing for adjustment of sweetness, mouthfeel, and stability as needed.

[0050] In a first aspect, the present invention provides: a film-forming composition comprising sodium carboxymethyl cellulose and hydroxypropyl methyl cellulose.

[0051] Among them are the technical features: sodium carboxymethyl cellulose and hydroxypropyl methyl cellulose.

[0052] Preferably, in the film-forming agent composition, the mass ratio of hydroxypropyl methylcellulose to sodium carboxymethyl cellulose is 2-4:1; more preferably, the mass ratio of hydroxypropyl methylcellulose to sodium carboxymethyl cellulose is 2-3:1. Even more preferably, the mass ratio of hydroxypropyl methylcellulose to sodium carboxymethyl cellulose is 2.8:1.

[0053] The film-forming agent composition further comprises at least one of polyvinyl alcohol, sodium alginate, corn starch, pullulan, xanthan gum, and pectin.

[0054] Preferably, the film-forming agent composition further comprises at least one of polyvinyl alcohol, corn starch, and pectin; more preferably, the film-forming agent composition further comprises at least one of polyvinyl alcohol and corn starch; most preferably, the film-forming agent composition further comprises polyvinyl alcohol.

[0055] Based on further solutions to the technical problems of the present invention, or simultaneous solutions to multiple technical problems, the preferred solution in the technical solution provided in the first aspect of the present invention includes: In the first preferred embodiment, the film-forming agent composition comprises sodium carboxymethyl cellulose and hydroxypropyl methylcellulose. Preferably, the mass ratio of hydroxypropyl methylcellulose to sodium carboxymethyl cellulose in the film-forming agent composition is 2-4:1; more preferably, the mass ratio is 2.8:1. This technical solution, while addressing the technical problem of "improving the solubility, mechanical properties, and bioavailability of film-forming candies," further addresses the technical problem of "further improving the solubility, mechanical properties, and bioavailability of film-forming candies."

[0056] Secondly, the present invention provides the use of the above-mentioned film-forming agent composition in the preparation of film-forming candies.

[0057] Among them, the technical feature is the application of the above-mentioned film-forming agent composition.

[0058] The preferred application of the above-mentioned film-forming agent is in the preparation of film-forming candies containing kudzu root.

[0059] The application of the above-mentioned film-forming agent is further preferred in that: the above-mentioned film-forming agent composition forms a continuous and uniform film structure on the surface or inside of the candy through its own film-forming properties, giving the product shape and integrity; the film formed by the above-mentioned film-forming agent composition can significantly improve the physical stability of the candy, resist the influence of the external environment on the product, and has the effects of moisture and water resistance, oxygen isolation, and temperature resistance regulation; the above-mentioned film-forming agent composition can also control the dissolution rate of the film in the oral cavity.

[0060] Thirdly, the present invention provides: a film-forming candy containing kudzu root, comprising: the above-mentioned film-forming agent composition, kudzu root powder, sugar alcohol, sweetener and plasticizer.

[0061] These include technical features such as sugar alcohols, sweeteners, and plasticizers.

[0062] The technical feature sugar alcohol is selected from at least one of xylitol, erythritol, sorbitol, maltitol, isomaltitol, and D-mannitol.

[0063] The preferred sugar alcohol in the technical feature is at least one of xylitol, erythritol, sorbitol, and maltitol.

[0064] Among them, the preferred sugar alcohols are xylitol and sorbitol.

[0065] Among them, the preferred sugar alcohol in terms of technical characteristics is xylitol.

[0066] The sweetener used in this process is selected from at least one of the following: sucralose, steviol glycosides, mogrosides, neotame, acesulfame potassium, and aspartame.

[0067] The preferred sweetener is selected from at least one of sucralose, steviol glycosides, acesulfame potassium, and aspartame.

[0068] The preferred sweeteners are sucralose and acesulfame potassium.

[0069] The preferred sweetener is sucralose.

[0070] The plasticizer in the technical feature is selected from at least one of glycerin, polyethylene glycol, sorbitol, and maltitol.

[0071] The preferred plasticizer is selected from at least one of glycerin, maltitol, and polyethylene glycol.

[0072] The preferred plasticizers are glycerin and polyethylene glycol.

[0073] The preferred plasticizer among the technical features is glycerin.

[0074] Preferably, the above-mentioned kudzu-containing film candy comprises, by weight: 20-45 parts of film-forming agent composition, 20-45 parts of kudzu powder, 20-30 parts of sugar alcohol, 0.1-0.15 parts of sweetener, and 5-8 parts of plasticizer.

[0075] For example: 20-30 servings, 30-40 servings, 25-45 servings, 20-38 servings, 30-35 servings, or 28-42 servings of kudzu root powder; 23-30 parts, 22-28 parts, 23-29 parts, 25-30 parts, or 21-25 parts sugar alcohol; Film-forming agent compositions in quantities of 20-30 parts, 30-40 parts, 25-45 parts, 20-38 parts, 30-35 parts, or 28-42 parts; 0.1-0.13 parts, 0.1-0.14 parts, 0.1-0.12 parts, 0.11-0.13 parts, or 0.12-0.15 parts of sweetener; 5-7 parts, 6-8 parts, 5-6 parts, 7-8 parts, or 6-7 parts of plasticizer.

[0076] For further examples: 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 40 or 45 servings of kudzu root powder; 21, 22, 23, 24, 25, 26, 27, 28, 29, or 30 servings of sugar alcohol; Film-forming agent compositions in quantities of 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 40, or 45 parts; 0.1, 0.11, 0.12, 0.13, 0.14, or 0.15 parts of sweetener; 5, 6, 7 or 8 parts plasticizer.

[0077] More preferably, the above-mentioned kudzu-containing film candy comprises, by weight: 20-40 parts of the film-forming agent composition, 20-35 parts of kudzu powder, 20-30 parts of sugar alcohol, 0.1-0.14 parts of sweetener, and 5-7 parts of plasticizer.

[0078] More preferably, the above-mentioned kudzu-containing film candy comprises, by weight: 35-40 parts of the film-forming agent composition, 25-35 parts of kudzu powder, 25-30 parts of sugar alcohol, 0.11-0.13 parts of sweetener, and 5-7 parts of plasticizer.

[0079] Most preferably, the above-mentioned kudzu-containing film candy comprises, by weight: 37 parts of the film-forming agent composition, 30 parts of kudzu powder, 28 parts of sugar alcohol, 0.12 parts of sweetener, and 6 parts of plasticizer.

[0080] Based on further solutions to the technical problems of the present invention, or simultaneous solutions to multiple technical problems, the preferred solution in the technical solution provided in the third aspect of the present invention includes: The first preferred option uses a sugar alcohol selected from at least one of xylitol, erythritol, sorbitol, maltitol, isomaltitol, and D-mannitol. Preferably, the sugar alcohol is at least one of xylitol, erythritol, sorbitol, and maltitol; further preferably, it is xylitol or sorbitol; and even more preferably, it is xylitol. This technical solution, having already addressed the technical problem of "improving the solubility, taste, and bioavailability of sheet candies," further addresses the technical problem of "further improving the solubility, taste, and bioavailability of sheet candies."

[0081] The second preferred option uses a sweetener selected from at least one of sucralose, steviol glycosides, mogrosides, neotame, acesulfame potassium, and aspartame. Preferably, the sweetener is at least one of sucralose, steviol glycosides, acesulfame potassium, and aspartame; further preferably, it is sucralose or acesulfame potassium; and even more preferably, it is sucralose. This technical solution, while addressing the technical problem of "improving the solubility, taste, and bioavailability of film-coated candies," further addresses the technical problem of "further improving the solubility, taste, and bioavailability of film-coated candies."

[0082] The third preferred option uses a plasticizer selected from at least one of glycerin, polyethylene glycol, sorbitol, and maltitol; preferably, the plasticizer is at least one of glycerin, maltitol, and polyethylene glycol; further preferably, the plasticizer is glycerin or polyethylene glycol; and even more preferably, the plasticizer is glycerin. This technical solution, having already addressed the technical problem of "improving the solubility, taste, and bioavailability of sheet candies," further addresses the technical problem of "further improving the solubility, taste, and bioavailability of sheet candies."

[0083] The fourth preferred embodiment has the following weight proportions for each component: 20-45 parts kudzu root powder, 20-30 parts sugar alcohol, 20-45 parts film-forming agent composition, 0.1-0.15 parts sweetener, and 5-8 parts plasticizer; wherein, the preferred weight proportions for each component are: 20-35 parts kudzu root powder, 20-30 parts sugar alcohol, 20-40 parts film-forming agent composition, 0.1-0.14 parts sweetener, and 5-7 parts plasticizer; wherein, the further preferred weight proportions for each component are: 25-35 parts kudzu root powder, 25-30 parts sugar alcohol, 35-40 parts film-forming agent composition, 0.11-0.13 parts sweetener, and 5-7 parts plasticizer; wherein, the even more preferred weight proportions for each component are: 30 parts kudzu root powder, 28 parts sugar alcohol, 37 parts film-forming agent composition, 0.12 parts sweetener, and 6 parts plasticizer. This technical solution, having already addressed the technical problem of "improving the solubility, taste, and bioavailability of sheet candies," further addresses the technical problem of "further improving the solubility, taste, and bioavailability of sheet candies."

[0084] Fourthly, the present invention provides a method for preparing the above-mentioned kudzu-containing film candy, comprising the steps of dissolving the above-mentioned components in a solvent, mixing, defoaming, coating, and drying to obtain the composition.

[0085] It includes technical features such as solvent, mixing, defoaming, coating, and drying.

[0086] The technical feature is that the solvent is selected from at least one of water, ethanol, glycerol, and acetic acid; The preferred solvents for the technical features are: water, ethanol, and glycerin. The preferred solvent for the technical feature is water or ethanol. The solvent for the technical feature is further preferably water.

[0087] The preferred solvents for the technical features are: purified water, ultrapure water, distilled water, drinking water, and mineral water.

[0088] The technical feature of mixing is selected from at least one of the following: stirring mixing, high-speed shear mixing, and step mixing.

[0089] Among them, the preferred combination of technical feature mixing is a combination of high-speed shear mixing and stepwise mixing; The preferred method for mixing the technical features is as follows: first, the sugar alcohol, sweetener, plasticizer, and film-forming agent composition is dissolved in a solvent and stirred until completely dispersed; finally, kudzu root powder is added and mixed at high speed. A more preferred method is to first dissolve the sugar alcohol, sweetener, and plasticizer in a solvent to form a homogeneous solution; then add the film-forming agent composition and stir to dissolve; finally, add kudzu root powder and mix at high speed.

[0090] The preferred speed of the high-speed stirring mixture is 100-2000 r / min, and more preferably 300-1500 r / min.

[0091] The defoaming technology is selected from at least one of the following: vacuum defoaming with stirring, centrifugal defoaming, ultrasonic defoaming, and step-by-step defoaming.

[0092] The preferred defoaming feature is vacuum defoaming with stirring; The vacuum defoaming process described above is further preferably characterized by a vacuum degree of 0.05-0.1 MPa. The vacuum defoaming process is further preferably characterized by a vacuum degree of 0.09-0.1 MPa.

[0093] The technical feature coating is selected from at least one of the following: dip coating, roller coating, doctor blade coating, atomized coating, and curtain coating.

[0094] The preferred coating methods for the technical features are: dip coating, roller coating, and doctor blade coating. Among them, the technical feature coating is further preferably: roller coating or blade coating; Among them, the technical feature coating is further preferably: blade coating; The thickness of the blade coating is preferably 0.01-1 mm, and more preferably 0.09 mm.

[0095] The technical drying method is selected from at least one of the following: freeze drying, oven drying, air drying, blow drying, natural drying, and vacuum drying.

[0096] The preferred drying technique is at least one of baking, air drying, and blow drying. Among them, the technical feature of drying is further preferably: drying; More preferably, the drying temperature is 80-95℃, and most preferably 85-90℃.

[0097] Preferably, the preparation method of the kudzu root-containing membrane candy includes the following steps: (1) Weigh out 30 parts of kudzu root powder, 28 parts of xylitol, 37 parts of hydroxypropyl methylcellulose and sodium carboxymethyl cellulose in a mass ratio of 2.8:1, 0.12 parts of sucralose, and 6 parts of glycerin according to the formula; (2) Dissolve xylitol, sucralose and glycerol in pure water and stir until completely dispersed to prepare a sweet solution for later use; (3) Add hydroxypropyl methylcellulose and sodium carboxymethyl cellulose in a mass ratio of 2.8:1 to the sweet solution in step (2), mix and stir thoroughly until completely dispersed, and prepare a water-soluble film-forming material solution for later use; (4) Add kudzu root powder to the water-soluble film-forming material solution in step (3), stir thoroughly at a speed of 300-1500 r / min for 4.5-6 hours, and perform vacuum defoaming treatment at a vacuum degree of 0.09-0.1 MPa to obtain the film-forming solution for later use. (5) Use a coating machine to evenly coat the film-forming solution in step (4) onto a flat backing material with a thickness of 0.9 mm, and dry it at 85-90℃. After drying, peel it off and cut it according to the weight requirements to obtain the required kudzu root film candy.

[0098] Based on further solutions to the technical problems of the present invention, or simultaneous solutions to multiple technical problems, the preferred solution in the technical solution provided in the fourth aspect of the present invention includes: The first preferred embodiment uses a solvent selected from at least one of water, ethanol, glycerol, and acetic acid; preferably, the solvent is water, ethanol, or glycerol; further preferably, the solvent is water or ethanol; even more preferably, the solvent is water; and the technically characteristic solvent is even more preferably purified water, ultrapure water, distilled water, drinking water, or mineral water. This technical solution, based on solving the technical problem of "improving the solubility of membrane candies and enhancing bioavailability," further solves the technical problem of "further improving the solubility of membrane candies and enhancing bioavailability."

[0099] The second preferred method is to select at least one of the following: stirring mixing, high-speed shear mixing, kneading mixing, and step mixing; wherein, the preferred method is to use a combination of high-speed shear mixing and step mixing. A further preferred method of mixing is as follows: first, the sugar alcohol, sweetener, plasticizer, and film-forming agent composition is dissolved in a solvent and stirred until completely dispersed; finally, kudzu root powder is added and mixed at high speed. An even more preferred method is as follows: first, the sugar alcohol, sweetener, and plasticizer are dissolved in a solvent to form a homogeneous solution; then, the film-forming agent composition is added and stirred until dissolved; finally, kudzu root powder is added and mixed at high speed. The speed of the high-speed mixing is preferably 100-2000 r / min, more preferably 300-1500 r / min. This technical solution, while addressing the technical problem of "improving the solubility and bioavailability of film-forming candies," further addresses the technical problem of "further improving the solubility and bioavailability of film-forming candies."

[0100] The third preferred method is defoaming, which is selected from at least one of the following: stirring vacuum defoaming, centrifugal defoaming, ultrasonic defoaming, and stepwise defoaming; wherein, the preferred method is stirring vacuum defoaming; the vacuum defoaming is further preferably characterized by a vacuum degree of 0.05-0.1 MPa; and the vacuum defoaming is even more preferably characterized by a vacuum degree of 0.09-0.1 MPa. This technical solution, based on solving the technical problem of "improving the solubility and bioavailability of membrane candies," further solves the technical problem of "further improving the solubility and bioavailability of membrane candies."

[0101] The fourth preferred method involves coating techniques selected from at least one of: dip coating, roller coating, blade coating, atomized coating, and curtain coating; wherein the coating is preferably: dip coating, roller coating, or blade coating; further preferably: roller coating or blade coating; even more preferably: blade coating; wherein the thickness of the blade coating is preferably 0.01-1 mm, and even more preferably 0.09 mm. This technical solution, based on solving the technical problem of "improving the solubility and bioavailability of membrane candies," further solves the technical problem of "further improving the solubility and bioavailability of membrane candies."

[0102] The fifth preferred method involves drying selected from at least one of the following: freeze drying, oven drying, air drying, blow drying, natural drying, and vacuum drying; preferably, oven drying, air drying, and blow drying; further preferably, oven drying; and even more preferably, the drying temperature is 80-95℃, most preferably 85-90℃. This technical solution, while addressing the technical problem of "improving the solubility and bioavailability of membrane candies," further addresses the technical problem of "further improving the solubility and bioavailability of membrane candies."

[0103] Embodiments 1-5 of this invention at least support the protection scope of claims 1-2.

[0104] Regarding the substances involved in claims 1-2: sodium carboxymethyl cellulose, hydroxypropyl methyl cellulose, and their proportions, etc.

[0105] The technical feature "in the film-forming agent composition, the mass ratio of hydroxypropyl methylcellulose to sodium carboxymethyl cellulose is 2-4:1" is summarized as "the mass ratio of hydroxypropyl methylcellulose to sodium carboxymethyl cellulose is 2:1", "the mass ratio of hydroxypropyl methylcellulose to sodium carboxymethyl cellulose is 4:1", and "the mass ratio of hydroxypropyl methylcellulose to sodium carboxymethyl cellulose is 2.8:1". Therefore, those skilled in the art can reasonably presume that the technical feature "the mass ratio of hydroxypropyl methylcellulose to sodium carboxymethyl cellulose is 2-4:1", its subordinate concepts, its substantially equivalent technical means, and technical means that can be replaced by conventional technical means and common knowledge based on the existing level of technology should all fall within the protection scope of claims 1-2.

[0106] Embodiments 4-5 of this invention at least support the protection scope of claims 9-11.

[0107] Regarding the use of the film-forming composition in the preparation of film-forming candies as described in claims 4-5.

[0108] The technical feature "application in the preparation of film-forming candies" is summarized by the foregoing explanation and / or the corresponding technical features in Examples 1-5, such as "the above-mentioned film-forming agent composition, through its own film-forming properties, forms a continuous and uniform thin film structure on the surface or inside of the candy, giving the product shape and integrity; the film formed by the above-mentioned film-forming agent composition can significantly improve the physical stability of the candy, resist the influence of the external environment on the product, and has the effects of moisture and water resistance, oxygen isolation, and temperature regulation; the above-mentioned film-forming agent composition can also control the dissolution rate of the film in the oral cavity" and "the desired kudzu film-forming candies can be obtained." Therefore, those skilled in the art can reasonably presume that the technical feature "application in the preparation of film-forming candies," its subordinate concepts, its substantially equivalent technical means, and technical means that can replace it within the scope of conventional technical means and common knowledge based on the existing level of technology should all fall within the protection scope of claims 4-5. Embodiments 1-5 of this invention at least support the protection scope of claims 6-8.

[0109] For claims 6-8, sugar alcohols, sweeteners, plasticizers, etc.

[0110] The technical feature "sugar alcohol" is derived from the aforementioned explanation and / or the corresponding technical features "xylitol, erythritol, sorbitol, maltitol, isomaltitol, D-mannitol," etc., in Examples 1-5, through the common feature "a class of polyol compounds generated from sugars through a reduction reaction, containing multiple hydroxyl groups (-OH) in the molecule." Therefore, those skilled in the art can reasonably presume that the technical feature "sugar alcohol," its subordinate concepts, its substantially equivalent technical means, and technical means that can replace "sugar alcohol" based on existing technology and conventional technical means and common knowledge should all fall within the protection scope of claims 6-8. For example, replacing "sugar alcohol" with "sugar-derived polyols" while keeping other technical features unchanged still falls within the protection scope of claims 6-8 of this invention.

[0111] Examples 1-5 and Comparative Example 9 verified that when the "sugar alcohol type" is selected from xylitol, the solubility of the film candy can be significantly improved, the bioavailability can be increased, and the taste can be enhanced.

[0112] The technical feature "sweetener" is derived from the aforementioned explanation and / or the corresponding technical features "sucralose, steviol glycosides, mogrosides, neotame, acesulfame potassium, aspartame," etc., in Examples 1-5, through the common feature "a substance that can impart sweetness to food, beverages, and other products, producing a sweet sensation by stimulating taste receptors." Therefore, those skilled in the art can reasonably presume that the technical feature "sweetener," its subordinate concepts, its substantially equivalent technical means, and technical means that can replace "sweetener" based on existing technology and conventional technical means and common knowledge, should all fall within the protection scope of claims 6-8. For example, replacing "sweetener" with "aspartame" while keeping other technical features unchanged still falls within the protection scope of claims 6-8 of this invention.

[0113] The technical feature "plasticizer" is derived from the aforementioned explanation and / or the corresponding technical features "glycerol, polyethylene glycol, sorbitol, maltitol," etc., in Examples 1-5, through the common feature "a substance that can insert between polymer molecular chains, reduce intermolecular forces, thereby enhancing the flexibility, plasticity, and processability of the material, and preventing material embrittlement." Therefore, those skilled in the art can reasonably presume that the technical feature "plasticizer," its subordinate concepts, its substantially equivalent technical means, and technical means that can replace "plasticizer" based on existing technology and conventional technical means and common knowledge should all fall within the protection scope of claims 6-8. For example, replacing "plasticizer" with "maltitol," etc., while keeping other technical features unchanged, still falls within the protection scope of claims 6-8 of this invention.

[0114] Examples 1-5 and Comparative Example 10 verified that when the "plasticizer type" is selected from glycerin, it can further significantly improve the solubility, bioavailability, and taste of the film candy.

[0115] The technical features “20-45 parts kudzu root powder, 20-30 parts sugar alcohol, 20-45 parts film-forming agent composition, 0.1-0.15 parts sweetener, and 5-8 parts plasticizer” are summarized from the corresponding technical features in the foregoing explanation and / or Examples 1-5, such as “20 parts kudzu root powder, 20 parts sugar alcohol, 20 parts film-forming agent composition, 0.1 parts sweetener, and 5 parts plasticizer”; “45 parts kudzu root powder, 30 parts sugar alcohol, 45 parts film-forming agent composition, 0.15 parts sweetener, and 8 parts plasticizer”; and “30 parts kudzu root powder, 28 parts sugar alcohol, 37 parts film-forming agent composition, 0.12 parts sweetener, and 6 parts plasticizer”. Therefore, based on reasonable presumption, those skilled in the art can determine that the technical feature “20-45 parts of kudzu root powder, 20-30 parts of sugar alcohol, 20-45 parts of film-forming agent composition, 0.1-0.15 parts of sweetener, and 5-8 parts of plasticizer”, its subordinate concepts, its essentially equivalent technical means, and technical means that can replace it within the scope of conventional technical means and common knowledge based on the existing technical level should all belong to the content recorded in “20-45 parts of kudzu root powder, 20-30 parts of sugar alcohol, 20-45 parts of film-forming agent composition, 0.1-0.15 parts of sweetener, and 5-8 parts of plasticizer”.

[0116] Embodiments 1-5 of this invention at least support the protection scope of claims 9-10.

[0117] For claims 9-10, the processes involved are: mixing, defoaming, coating, and drying.

[0118] The technical feature "mixing" is derived from the aforementioned explanation and / or the corresponding technical features "at least one of stirring mixing, high-speed stirring mixing, and stepwise mixing" in Examples 1-5, and is summarized by the common feature "the process of mixing two or more different substances by physical or mechanical means to form a macroscopically uniform or relatively uniform dispersion system." Therefore, those skilled in the art can reasonably presume that the technical feature "mixing," its subordinate concepts, its substantially equivalent technical means, and technical means that can replace "mixing" based on existing technology and conventional technical means and common knowledge should all fall within the protection scope of claims 9-10. For example, replacing "mixing" with "mixing and dispersion" while keeping other technical features unchanged still falls within the protection scope of claims 9-10 of this invention.

[0119] The technical feature "defoaming" is derived from the aforementioned explanation and / or the corresponding technical features in Examples 1-5, such as "at least one of stirring vacuum defoaming, centrifugal defoaming, ultrasonic defoaming, and stepwise defoaming," through the common feature "the process of uniformly coating a liquid slurry, solution, or molten material onto the surface of a substrate by brushing, spraying, dipping, etc., and then forming a thin film through subsequent treatment (such as drying and curing)." Therefore, those skilled in the art can reasonably presume that the technical feature "defoaming," its subordinate concepts, its substantially equivalent technical means, and technical means that can replace "defoaming" based on existing technology and conventional technical means and common knowledge should all fall within the protection scope of claims 9-10. For example, replacing "defoaming" with "negative pressure defoaming" while keeping other technical features unchanged still falls within the protection scope of claims 9-10 of this invention.

[0120] The technical feature "coating" is derived from the common feature "a process of mixing two or more different substances through physical or mechanical means to form a uniform or relatively uniform dispersion system" in the aforementioned explanation and / or Examples 1-5, such as "at least one of impregnation coating, roller coating, doctor blade coating, atomization coating, and curtain coating". Therefore, those skilled in the art can reasonably presume that the technical feature "coating", its subordinate concepts, its substantially equivalent technical means, and technical means that can replace "coating" based on the existing level of technology and conventional technical means and common knowledge should all fall within the protection scope of claims 9-10. For example, replacing "coating" with "film coating" while keeping other technical features unchanged still falls within the protection scope of claims 9-10 of this invention.

[0121] The technical feature "drying" is derived from the aforementioned explanation and / or the corresponding technical features in Examples 1-5, such as "at least one of freeze-drying, oven-drying, air-drying, blow-drying, natural drying, and vacuum drying," through the common feature "a process of reducing the moisture content of a material by evaporating moisture or volatile solvents through heating, ventilation, vacuum, or other means." Therefore, those skilled in the art can reasonably presume that the technical feature "drying," its subordinate concepts, its substantially equivalent technical means, and technical means that can replace "drying" based on existing technology and conventional technical means and common knowledge, should all fall within the protection scope of claims 9-10. For example, replacing "drying" with "dehydration treatment" while keeping other technical features unchanged still falls within the protection scope of claims 9-10 of this invention.

[0122] The beneficial effects of this invention are as follows: The present invention has at least the following beneficial effects: (1) This invention uses kudzu root powder, which is a water extract of kudzu root, as the main raw material to prepare a film candy containing kudzu root. This preparation increases the solubility of kudzu root, reduces the bitterness of kudzu root, and has excellent characteristics such as melting in the mouth, good taste, small amount of excipients, and portability.

[0123] (2) The film candy dissolves in the oral cavity and is partially absorbed by the oral mucosa, thus greatly improving its bioavailability.

[0124] (3) Compared with the prior art, the present invention has better technical effects in terms of the solubility, bioavailability and product stability of membrane candies.

[0125] According to experimental tests, the present invention reduces the solubility of film candies from that of existing compressed candies and capsules to below 50 seconds.

[0126] According to experimental tests, this invention improves bioavailability compared to existing compressed candies and capsules by avoiding the first-pass effect and increasing absorption efficiency.

[0127] (4) Compared with the prior art, the present invention provides a technical solution with a different technical concept, and its technical effect is equivalent to or slightly improved with the prior art. The difference between the technical concept of the present invention and the prior art includes that, in order to improve solubility and bioavailability, the product form adopted by the present invention is a film candy form, which dissolves quickly after entering the mouth (or dissolves on the oral mucosa), releases ingredients quickly, achieves the purpose of rapid absorption, and has a more refreshing taste, etc., while the prior art mostly adopts the form of compressed candy, which is harder when chewed, needs to be dissolved by saliva or broken by chewing, and releases ingredients more slowly.

[0128] Furthermore, based on the present invention: 1. Based on the comparison of Example 3 and Comparative Examples 1 and 2, the present invention uses a drying temperature range of 85-90℃ for the film candy. The drying temperature of Comparative Example 1 is 70-75℃, which is too low. The high water content in the film candy results in low strength after film formation, making it easy to stick to the palate during use and affecting the disintegration of the film candy in the mouth. The drying temperature of Comparative Example 2 is 96-100℃, which is too high. The low water content in the film candy results in a brittle film after film formation, leading to low strength after film formation and easy breakage during use.

[0129] 2. Based on the comparison of Example 3 and Comparative Examples 3-4, the present invention utilizes a combination of hydroxypropyl methylcellulose and sodium carboxymethyl cellulose, achieving new technical effects and improving the solubility and bioavailability of the film-coated candy. The combined technical effect is superior to the sum of the effects of each individual technique.

[0130] 3. Based on the comparison of Example 3 and Comparative Examples 7-8, the present invention intentionally selects a narrower range not mentioned in the prior art, namely, a film-forming agent composition of two specific components, namely "hydroxypropyl methylcellulose and sodium carboxymethyl cellulose", from the broad range of "hydroxypropyl methylcellulose, amylopectin, sodium alginate, pullulan, povidone-vinyl acetate or sodium carboxymethyl cellulose" disclosed in the prior art. This has achieved unexpected technical effects such as "improving the tensile strength and flexibility of the film candy, while shortening the disintegration time, etc."

[0131] 4. Among them, Example 3 and Comparative Example 11 verified that using purified water as a solvent can further significantly improve the solubility, bioavailability and taste of the film candy. Detailed Implementation

[0132] The following non-limiting embodiments are intended to enable those skilled in the art to gain a more comprehensive understanding of the present invention, but do not limit the invention in any way. The following content is merely an exemplary description of the scope of protection claimed by the present invention, and those skilled in the art can make various changes and modifications to the present invention based on the disclosed content, and such changes should also fall within the scope of protection claimed by the present invention.

[0133] The present invention will be further described below by way of specific embodiments. Unless otherwise specified, all instruments, devices, equipment, reagents, products, etc., used in the embodiments of the present invention are obtained through conventional commercial means.

[0134] In the following embodiments, The hydroxypropyl methylcellulose was purchased from Anhui Shanhe Pharmaceutical Excipients Co., Ltd., and the model number is SH-FE5.

[0135] Sodium carboxymethyl cellulose was purchased from Anhui Shanhe Pharmaceutical Excipients Co., Ltd., model number: SH-SJJ-800.

[0136] Kudzu root powder: purchased from Ningxia Guosheng Biotechnology Co., Ltd., model number 50:1.

[0137] Polyvinyl alcohol: purchased from Jiangxi Alpha High-Tech Pharmaceutical Co., Ltd., model number: 1788.

[0138] Corn starch: purchased from Anhui Shanhe Pharmaceutical Excipients Co., Ltd., model number: SH-M.

[0139] Pectin: Purchased from Henan Guangheng Food Ingredients Co., Ltd., model number: 501.

[0140] Example 1 A type of kudzu root film-coated candy, by weight, comprises the following raw and auxiliary materials: 20 parts kudzu root powder, 20 parts sugar alcohol, 20 parts film-forming agent composition, 0.1 parts sweetener, 5 parts plasticizer, and purified water.

[0141] The sugar alcohol mentioned is xylitol; The film-forming agent composition is hydroxypropyl methylcellulose and sodium carboxymethyl cellulose in a mass ratio of 2.8:1; The sweetener is sucralose; The plasticizer is glycerin; The preparation method of the membrane candy is as follows: (1) Weigh the corresponding weight of raw materials according to the formula; (2) Place purified water in a mixing tank, add sugar alcohol, sweetener and plasticizer, stir until completely dispersed, and prepare a sweet solution for later use; (3) Add the film-forming agent composition to the sweet solution and mix thoroughly until completely dispersed to obtain a water-soluble film-forming material solution for later use; (4) Add kudzu root powder to the water-soluble film-forming material solution, stir thoroughly and defoam, and prepare the film-forming solution for later use; (5) Use a coating machine to evenly coat the above film-forming solution onto a flat backing material and dry it. After drying, peel it off and cut it according to the weight requirements to obtain the desired kudzu root film candy.

[0142] In step (4), the stirring speed of the kudzu root solution is 1200 r / min; the vacuum degree of vacuum defoaming is 0.09-0.1 MPa, and the stirring and defoaming time is 5 hours.

[0143] The coating thickness is 0.9 mm.

[0144] The drying temperature for the film candy in step (5) is 85-90℃.

[0145] Example 2 A type of kudzu root film-coated candy, by weight, comprises the following raw and auxiliary materials: 45 parts kudzu root powder, 30 parts sugar alcohol, 45 parts film-forming agent composition, 0.15 parts sweetener, 8 parts plasticizer, and purified water.

[0146] The sugar alcohol mentioned is xylitol; The film-forming agent composition is hydroxypropyl methylcellulose and sodium carboxymethyl cellulose in a mass ratio of 2.8:1; The sweetener is sucralose; The plasticizer is glycerin; The preparation method of the membrane candy is as follows: (1) Weigh the corresponding weight of raw materials according to the formula; (2) Place purified water in a mixing tank, add sugar alcohol, sweetener and plasticizer, stir until completely dispersed, and prepare a sweet solution for later use; (3) Add the film-forming agent composition to the sweet solution and mix thoroughly until completely dispersed to obtain a water-soluble film-forming material solution for later use; (4) Add kudzu root powder to the water-soluble film-forming material solution, stir thoroughly and defoam, and prepare the film-forming solution for later use; (5) Use a coating machine to evenly coat the above film-forming solution onto a flat backing material and dry it. After drying, peel it off and cut it according to the weight requirements to obtain the desired kudzu root film candy.

[0147] In step (4), the stirring speed of the kudzu root solution is 300 r / min; the vacuum degree of vacuum defoaming is 0.09-0.1 MPa, and the stirring and defoaming time is 6 hours.

[0148] The coating thickness is 0.9 mm.

[0149] The drying temperature for the film candy in step (5) is 85-90℃.

[0150] Example 3 A type of kudzu root film-coated candy, by weight, comprises the following raw and auxiliary materials: 30 parts kudzu root powder, 28 parts sugar alcohol, 37 parts film-forming agent composition, 0.12 parts sweetener, 6 parts plasticizer, and purified water.

[0151] The sugar alcohol mentioned is xylitol; The film-forming agent composition is hydroxypropyl methylcellulose and sodium carboxymethyl cellulose in a mass ratio of 2.8:1; The sweetener is sucralose; The plasticizer is glycerin; The preparation method of the membrane candy is as follows: (1) Weigh the corresponding weight of raw materials according to the formula; (2) Place purified water in a mixing tank, add sugar alcohol, sweetener and plasticizer, stir until completely dispersed, and prepare a sweet solution for later use; (3) Add the film-forming agent composition to the sweet solution and mix thoroughly until completely dispersed to obtain a water-soluble film-forming material solution for later use; (4) Add kudzu root powder to the water-soluble film-forming material solution, stir thoroughly and defoam, and prepare the film-forming solution for later use; (5) Use a coating machine to evenly coat the above film-forming solution onto a flat backing material and dry it. After drying, peel it off and cut it according to the weight requirements to obtain the desired kudzu root film candy.

[0152] In step (4), the stirring speed of the kudzu root solution is 1500 r / min; the vacuum degree of vacuum defoaming is 0.09-0.1 MPa, and the stirring and defoaming time is 4.5 hours.

[0153] The coating thickness is 0.9 mm.

[0154] The drying temperature for the film candy in step (5) is 85-90℃.

[0155] Example 4 Unlike Example 3, the film-forming agent composition is hydroxypropyl methylcellulose and sodium carboxymethyl cellulose in a mass ratio of 2:1, all other aspects are the same.

[0156] Example 5 Unlike Example 3, the film-forming agent composition is hydroxypropyl methylcellulose and sodium carboxymethyl cellulose in a mass ratio of 4:1, all other aspects are the same.

[0157] Example 6 Unlike Example 3, the film-forming agent composition is hydroxypropyl methylcellulose, sodium carboxymethyl cellulose and polyvinyl alcohol in a mass ratio of 2.8:1:1, and all other components are the same.

[0158] Example 7 Unlike Example 3, the film-forming agent composition is hydroxypropyl methylcellulose, sodium carboxymethyl cellulose and corn starch in a mass ratio of 2.8:1:1, and all other components are the same.

[0159] Example 8 Unlike Example 3, the film-forming agent composition is hydroxypropyl methylcellulose, sodium carboxymethyl cellulose and pectin in a mass ratio of 2.8:1:1, and all other components are the same.

[0160] Comparative Example 1 Unlike Example 3, the temperature for drying the sheet candies was 70-75°C, but all other conditions were the same.

[0161] Comparative Example 2 Unlike Example 3, the temperature for drying the sheet candies was 96-100°C, but all other conditions were the same.

[0162] Comparative Example 3 The difference from Example 3 is that the film-forming agent is hydroxypropyl methylcellulose, but everything else is the same.

[0163] Comparative Example 4 The difference from Example 3 is that the film-forming agent is sodium carboxymethyl cellulose, but everything else is the same.

[0164] Comparative Example 5 Unlike Example 3, the film-forming agent composition is hydroxypropyl methylcellulose and sodium carboxymethyl cellulose in a mass ratio of 5:1, all other aspects are the same.

[0165] Comparative Example 6 Unlike Example 3, the film-forming agent composition is hydroxypropyl methylcellulose and sodium carboxymethyl cellulose in a mass ratio of 1:1, all other aspects are the same.

[0166] Comparative Example 7 Unlike Example 3, the film-forming agent is hydroxypropyl methylcellulose and polyvinyl alcohol in a mass ratio of 2.8:1, otherwise the same.

[0167] Comparative Example 8 Unlike Example 3, the film-forming agent is hydroxypropyl methylcellulose and corn starch in a mass ratio of 2.8:1, otherwise the same.

[0168] Comparative Example 9 The difference from Example 3 is that the sugar alcohol used is sorbitol, but everything else is the same.

[0169] Comparative Example 10 The difference from Example 3 is that the plasticizer is polyethylene glycol, but everything else is the same.

[0170] Comparative Example 11 The difference from Example 3 is that the solvent is ethanol, but everything else is the same.

[0171] Example 1: Sensory Testing Thirty volunteers were selected to evaluate the membrane's appearance, including its integrity, smoothness, uniform color, and absence of obvious bubbles. The scores were as follows: Integrity and smoothness, consistent thickness, uniform color, and absence of obvious bubbles (85-100 points); Relatively complete and smoothness, relatively consistent thickness, relatively uniform color, and a few obvious bubbles (70-84 points); Incomplete and roughness, inconsistent thickness, uneven color, and obvious bubbles (<70 points). The average score was used.

[0172] Test Example 2: Physical Property Testing of Membranes Thirty volunteers were selected to rate the membrane's strength and flexibility, categorizing them into three levels: good (85-100 points), poor (70-85 points), and very poor (≤70 points). The performance test results for different formulation samples are shown in Table 1.

[0173] Test Example 3: Tensile Strength Test Testing method: Tensile strength, also known as ultimate tensile strength, refers to the maximum force required to break an oral film.

[0174] The test was performed using an intelligent electronic tensile testing machine.

[0175] Tensile strength calculation formula: Tensile strength = Applied stress / Cross-sectional area.

[0176] Among them, films with low tensile strength are more brittle.

[0177] Test Example 4: Film Thickness Measurement A thickness gauge is used to measure the sample. A 100mm wide sample without wrinkles or other defects is placed on the test platform, and the measurement begins. The instrument automatically calculates the sample result.

[0178] Example 5: Moisture Content Test A halogen rapid moisture analyzer was used for testing. The halogen moisture analyzer was turned on, and the temperature was set to 105℃ and the time to 10 minutes. A 3g sample of the material to be tested was placed into the halogen moisture analyzer. The test was completed, and the results were recorded.

[0179] Example 6: Disintegration Time Detection The membrane candies prepared in each example and comparative example were placed in a petri dish containing 20 mL of purified water at a temperature of 37 ± 0.5 °C, and the time for complete dissolution of the sample was recorded. This time is the disintegration time. Among them, a dissolution time ≤ 50 s is considered rapid dissolution; a dissolution time of 50 s-120 s is considered moderate dissolution; and a dissolution time > 120 s is considered slow dissolution.

[0180] Table 1. Performance test results of Examples 1-8

[0181] Table 2. Performance test results of Comparative Examples 1-5

[0182] Table 3. Performance test results of Comparative Example 6-11

[0183] Verification of technical effectiveness and / or analysis of technical problem solving The results above show that the orally disintegrating films prepared in Examples 1-5 exhibit good flexibility, mechanical properties, and disintegration properties. In Comparative Example 7, the film-forming materials were hydroxypropyl methylcellulose and polyvinyl alcohol. Polyvinyl alcohol showed good film-forming effect and improved mucosal adhesion, but it also resulted in excessively sticky film surface and affected the dissolution rate of the candy. In Comparative Example 1, due to the low drying temperature, the high water content in the candy led to lower film strength after molding, making it prone to sticking to the palate during use and affecting the disintegration of the candy in the mouth. In Comparative Example 2, due to the high drying temperature, the low water content in the candy resulted in a brittle film after molding, leading to lower film strength and easy breakage during use.

[0184] Compared with Comparative Examples 3-4, Example 3 uses a single component of the film-forming agent composition of the present invention, resulting in a film with poor flexibility, and its tensile strength and disintegration time are not as good as those obtained by using hydroxypropyl methylcellulose and sodium carboxymethyl cellulose in combination. Compared with Comparative Examples 7-8, Example 3 replaces the components in the film-forming agent composition of the present invention with "polyvinyl alcohol" and "corn starch", which significantly prolongs the disintegration time. In Comparative Example 11, after replacing the solvent in the preparation of the film candy with ethanol, the film-forming effect, tensile strength, flexibility, and disintegration time of the film candy are not as good as those in Example 3 because ethanol will evaporate during the drying process.

[0185] In summary, the oral dissolving film prepared according to the embodiments of the present invention has a simple preparation process, good flexibility, mechanical properties and disintegration properties, and has broad application prospects.

[0186] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, and is not intended to limit the scope of protection of the present invention. Simple modifications or equivalent substitutions made by those skilled in the art to the technical solution of the present invention do not depart from the essence and scope of the technical solution of the present invention.

Claims

1. A film-forming agent composition, characterized in that, The film-forming agent composition consists of sodium carboxymethyl cellulose and hydroxypropyl methyl cellulose.

2. The film-forming agent composition according to claim 1, characterized in that, In the film-forming agent composition, the mass ratio of hydroxypropyl methylcellulose to sodium carboxymethyl cellulose is 2-4:1, preferably 2-3:1, and more preferably 2.8:

1.

3. The film-forming composition according to any one of claims 1-2, characterized in that, The film-forming agent composition further comprises at least one of polyvinyl alcohol, sodium alginate, corn starch, pullulan, xanthan gum, and pectin, preferably at least one of polyvinyl alcohol, corn starch, and pectin, more preferably at least one of polyvinyl alcohol and corn starch, and most preferably polyvinyl alcohol.

4. The use of the film-forming composition according to any one of claims 1-3 in the preparation of film-forming candies.

5. The application according to claim 4, characterized in that, The film candy is a film candy containing kudzu root.

6. A film-form candy containing kudzu root, characterized in that, It includes the film-forming composition according to any one of claims 1-3, kudzu root powder, sugar alcohol, sweetener and plasticizer.

7. The kudzu-containing film candy according to claim 6, characterized in that, The sugar alcohol is at least one of xylitol, erythritol, sorbitol, maltitol, isomaltitol, and D-mannitol, preferably at least one of xylitol, erythritol, sorbitol, and maltitol, more preferably xylitol and sorbitol, and most preferably xylitol; The sweetener is at least one of sucralose, steviol glycosides, mogrosides, neotame, acesulfame potassium, and aspartame, preferably at least one of sucralose, steviol glycosides, acesulfame potassium, and aspartame, more preferably sucralose and acesulfame potassium, and most preferably sucralose. The plasticizer is at least one of glycerol, polyethylene glycol, sorbitol, and maltitol, preferably at least one of glycerol, maltitol, and polyethylene glycol, more preferably glycerol and maltitol, and most preferably glycerol.

8. The kudzu-containing film candy according to any one of claims 6-7, characterized in that, The kudzu-containing film-forming candy comprises, by weight, 20-45 parts of the film-forming agent composition according to any one of claims 1-3, 20-45 parts of kudzu root powder, 20-30 parts of sugar alcohol, 0.1-0.15 parts of sweetener, and 5-8 parts of plasticizer; preferably, by weight, it comprises: 20-40 parts of the film-forming agent composition according to any one of claims 1-3, 20-35 parts of kudzu root powder, 20-30 parts of sugar alcohol, and 0.1-0.14 parts of sweetener. The film-forming agent comprises 5-7 parts by weight; more preferably, it comprises, by weight: 35-40 parts of the film-forming agent composition according to any one of claims 1-3, 25-35 parts of kudzu root powder, 25-30 parts of sugar alcohol, 0.11-0.13 parts of sweetener, and 5-7 parts of plasticizer; most preferably, it comprises, by weight: 37 parts of the film-forming agent composition according to any one of claims 1-8, 30 parts of kudzu root powder, 28 parts of sugar alcohol, 0.12 parts of sweetener, and 6 parts of plasticizer.

9. A method for preparing a kudzu-containing membrane candy according to any one of claims 6-8, characterized in that, The process includes the following steps: dissolving each component in a solvent, mixing, defoaming, coating, and drying.

10. The preparation method according to claim 9, characterized in that, The solvent is at least one of water, ethanol, glycerol, propylene glycol, and acetic acid, preferably water, ethanol, and glycerol, more preferably water and ethanol, and most preferably water; The mixing process combines high-speed stirring and stepwise mixing. Preferably, the sugar alcohol, sweetener, plasticizer, and film-forming agent composition is first dissolved in a solvent and stirred until completely dispersed; then, kudzu root powder is added and mixed with high-speed stirring. More preferably, the sugar alcohol, sweetener, and plasticizer are first dissolved in a solvent to form a homogeneous solution; then, the film-forming agent composition is added and stirred until dissolved; finally, kudzu root powder is added and mixed with high-speed stirring. Preferably, the high-speed stirring speed is 100-2000 r / min, more preferably 300-1500 r / min; The defoaming is performed by stirring and vacuum defoaming. Preferably, the vacuum degree of stirring and vacuum defoaming is 0.05-0.1 MPa. More preferably, the vacuum degree of stirring and vacuum defoaming is 0.09-0.1 MPa. The coating is a blade coating, and the thickness of the blade coating is 0.01-1 mm, more preferably 0.09 mm; The drying process is called baking, and the baking temperature is 80-95℃, more preferably 85-90℃.

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