A combined instant preparation, process for its preparation and use

Abstract

The present application relates to the technical field of preparation, and specifically includes pharmaceutical preparation, food, health preparation, medical device, daily necessities and cosmetics, etc. Specifically, it relates to a combined instant preparation, a preparation method and application thereof. The combined instant preparation comprises at least one layer of low-moisture, instant and porous body and at least one layer of low-moisture, instant and adhesive body containing oil. The porous body comprises a binder and a skeleton support agent, and the weight ratio of the two is 1:10-10:1. The adhesive body comprises oil and a skeleton support agent, and the weight ratio of the two is 1:10-10:1. The combined instant preparation can realize instant dissolution, carry a large amount of oil, and thus improve the product efficacy, and can be used in the fields of daily chemical washing and protection, functional food, etc.

Description

Technical Field

[0001] This invention relates to the field of chemical preparation technology, such as pharmaceutical preparations, food, health products, medical devices, daily necessities and cosmetics, and in particular to a combination of fast-dissolving preparations, its preparation method and application. Background Technology

[0002] Currently, there are oral or topical preparations available on the market in the form of freeze-dried pellets, containing medicinal or skin-care active ingredients. For example, freeze-dried pellets for skincare are made using a freeze-drying process, which ensures the activity of the skincare active ingredients and allows for rapid dissolution and mixing with the solvent during use. However, because freeze-drying is a process that requires a certain amount of oils and surfactants, it is difficult to add sufficient amounts of these ingredients. This is because oils separate from the water phase during freezing, disrupting the structural uniformity and stability of the freeze-dried pellets. Furthermore, the hydrophobic nature of oils can interfere with the drying process, ultimately leading to product disintegration or the inability to maintain the freeze-dried form.

[0003] Therefore, due to the difficulty in adding sufficient oil phase components, existing skincare freeze-dried balls are unable to provide functions such as moisturizing and repairing the skin barrier, which is particularly disadvantageous for skin types that require deep hydration, such as dry skin and sensitive skin. Users also need to use them with additional moisturizing oil or lotion to meet comprehensive skincare needs, which increases the steps and complexity of use. Summary of the Invention

[0004] To address the technical problems of existing freeze-dried pellet products, such as limited efficacy and inconvenience due to the inability to add oil phase components, this invention provides a combined instant-dissolving formulation, its preparation method, and its application. This combined instant-dissolving formulation achieves rapid dissolution and can carry a large amount of oils and surfactants, thereby improving product efficacy.

[0005] To achieve the above objectives, the technical solution adopted by the present invention is as follows:

[0006] A combined instant-dissolving formulation includes at least one layer of a low-water-content, instant-dissolving, porous body and at least one layer of a low-water-content, oil-containing, instant-dissolving binder.

[0007] Furthermore, it can be a two-layer, three-layer, or more structure;

[0008] When a two-layer structure is used, one layer is a loose porous body with low water content and fast dissolution, and the other layer is a binder with low water content, containing oil and being fast dissolution in water or oil.

[0009] When a three-layer structure is adopted, it includes an outer layer and an intermediate layer. The outer layer is a loose porous body with low water content and fast dissolution. There are two outer layers, which are located on both sides of the intermediate layer. The intermediate layer is a binder with low water content, containing oil and being fast dissolvable in water or oil. The intermediate layer is located between the two outer layers and is bonded to the two outer layers respectively.

[0010] When a structure with three or more layers is adopted, at least one layer is a loose porous body with low water content and fast dissolution, and at least one layer is a binder with low water content, containing oil and being fast dissolution in water or oil.

[0011] Furthermore, the weight ratio of the loose porous body to the adhesive is 1:10 to 10:1, preferably 1:5 to 5:1, and more preferably 1:3 to 3:1.

[0012] Furthermore, the loose porous body contains a binder and a skeleton support agent, with a weight ratio of 1:10 to 10:1, preferably 1:5 to 5:1, and more preferably 1:3 to 3:1.

[0013] The binder is selected from one or more of the following: gums, microbial fermentation gums, cellulose derivatives, seaweed extract gums, animal-derived gums, synthetic and semi-synthetic polymers, modified starches, starch, modified cellulose, cellulose ethers, hyaluronic acid, carbomer, sodium alginate, polyvinyl alcohol, polyethylene glycol, polyamino acids, povidone, and sodium polyacrylate. Preferably, it can be selected from one or more of pullulan, xanthan gum, polyvinyl alcohol, gelatin, carbomer, carrageenan, glucomannan, hydroxypropyl methylcellulose, sodium polyacrylate, guar gum, and gum arabic. Its dosage is 3% to 95% of the total loose porous material, preferably 3% to 60%, and further preferably 3% to 20%.

[0014] The skeletal support agent can be selected from sugars, sugar alcohols, dextrins, amino acids, inorganic substances, minerals, proteins, starches, self-emulsifying composite waxes, and modified cellulose, preferably one or more of mannitol, maltodextrin, glycine, trehalose, corn starch, starch, β-cyclodextrin, sugar, and kaolin. Its dosage is 5% to 95% of the total loose porous material, preferably 10% to 80%, and further preferably 30% to 60%.

[0015] Furthermore, the loose porous body also contains active ingredients. These active ingredients are selected from one or more of the following: chemical drug components, traditional Chinese medicine components, natural extracts, bioactive components, disinfectants, nutritional supplements, and components beneficial to skin care; preferably, they may be selected from one or more of ginseng, red ginseng, American ginseng, Lactobacillus acidophilus, vitamin C, caffeine, glycyrrhizin, and palmitoyl tetrapeptide-5. The dosage is 1% to 95% of the total loose porous body material, preferably 1% to 50%, and further, 1% to 30%. It should be noted that when the active ingredient itself has characteristics of oil, surfactant, skeleton agent, or binder, the dosage of the active ingredient is not limited by the above-mentioned dosage range, but belongs to the dosage range of oil, surfactant, skeleton agent, or binder, respectively.

[0016] Furthermore, the loose porous body also contains a surfactant. The surfactant is selected from one or more of anionic surfactants, cationic surfactants, amphoteric surfactants, nonionic surfactants, and amino acid surfactants; preferably, it can be selected from one or more of phospholipids, sodium methylcocoyl taurate, sodium lauroyl glutamate, lauryl glucoside, cocoyl glucoside, cocamidopropyl betaine, sucrose laurate, sodium lauroyl lactylate, sodium cocoyl glutamate, sodium lauroyl ethanesulfonate, sodium lauroyl amphoteric acetate, disodium cocoyl amphoteric diacetate, sodium α-alkenyl sulfonate, sodium lauroyl sarcosinate, sodium cocoyl sarcosinate, and potassium cocoyl glycinate. Its dosage is 1% to 95% of the total loose porous body material, preferably 1% to 50%, and further, 1% to 30%.

[0017] Furthermore, when used in shampoo and shower gels, an HLB value > 10 is required.

[0018] Furthermore, the adhesive is grease, whipped grease, or a mixture of grease and a skeleton support agent; when grease and a skeleton support agent are used, their weight ratio is 1:10 to 10:1. Preferably, it is 1:5 to 5:1, and more preferably 1:3 to 3:1.

[0019] The oil is selected from one or more of the following: animal fats, vegetable oils, synthetic / semi-synthetic oils, camellia oil, *Sapindus mukorossi* oil, hydrogenated vegetable oil, butter, palm oil, anhydrous shortening, petrolatum, shea butter, cocoa butter, coconut oil, lanolin, beeswax, shortening, olive emulsifying wax, hydrogenated lecithin, squalane, and cetearyl alcohol (for emulsification). Its dosage is 10% to 100% of the total binder material, preferably 20% to 80%, and further, 30% to 70%.

[0020] Furthermore, the oil also contains a surfactant, which is selected from one or more of anionic surfactants, cationic surfactants, amphoteric surfactants, nonionic surfactants, and amino acid surfactants; preferably, it may be selected from one or more of phospholipids, sodium methylcocoyl taurate, sodium lauroyl glutamate, lauryl glucoside, cocoyl glucoside, cocamidopropyl betaine, sucrose laurate, sodium lauroyl lactylate, sodium cocoyl glutamate, sodium lauroyl ethanesulfonate, sodium lauroyl amphoteric acetate, disodium cocoyl amphoteric diacetate, sodium α-alkenyl sulfonate, sodium lauroyl sarcosinate, sodium cocoyl sarcosinate, and potassium cocoyl glycinate. The weight ratio of the fat-soluble surfactant to the oil is 1:10 to 10:1, preferably 1:5 to 5:1, and more preferably 1:3 to 3:1.

[0021] The skeletal support agent is selected from sugars, sugar alcohols, dextrins, amino acids, inorganic substances, minerals, proteins, starches, self-emulsifying composite waxes, and modified cellulose, preferably one or more of mannitol, maltodextrin, glycine, trehalose, corn starch, starch, β-cyclodextrin, sugar, and kaolin; its dosage is 5% to 95% of the total material of the binder, preferably 5% to 55%, and further can be 5% to 35%.

[0022] Furthermore, the adhesive also contains an active ingredient; the active ingredient is selected from one or more of chemical drug components, traditional Chinese medicine components, natural extracts, bioactive components, disinfectants, and nutritional supplements; its dosage is 1% to 95% of the total material of the adhesive, preferably 1% to 50%, and more preferably 1% to 30%. It should be noted that when the active ingredient itself has characteristics of oil, surfactant, skeleton agent, or binder, the dosage of the active ingredient is not limited by the above-mentioned dosage range of active ingredients, but belongs to the dosage range of oil, surfactant, skeleton agent, or binder, respectively.

[0023] Furthermore, the low water content in the loose porous body and the binder refers to a moisture content of ≤10%, preferably ≤7%, and more preferably ≤5%.

[0024] Furthermore, when used in skincare product spheres, the following requirements must be met: moisture content ≤ 5% (Karl Fischer method); water activity (Aw) ≤ 0.60; complete dissolution, no foreign matter, and no turbidity. Excessive moisture content (> 5%) leads to active ingredient degradation, oxidation, microbial risk, clumping, and slow reconstitution; insufficient moisture content (< 1%) results in brittle structure, powdering, uneven reconstitution, excipient crystallization, and a poorer skin feel.

[0025] The method for preparing the combined instant dissolving formulation of the present invention includes the following: the loose porous body is obtained by drying, including baking, microwave drying, infrared drying, airflow drying, low-temperature vacuum drying, and freeze drying, and is in the form of a flat or hemispherical shape; the binder is obtained by whipping or emulsification process.

[0026] Freeze-drying, also known as lyophilization, involves freezing. During the freezing stage, water molecules aggregate to form ice crystals, which are dispersed throughout the material. In the vacuum sublimation stage, the solid ice crystals sublimate directly, creating numerous cavities and ultimately forming a low-water-content, hemispherical, porous body. When encountering a solvent such as water, water is instantly drawn into these channels. The contact area between water and the porous body is extremely large, allowing for rapid penetration, dissolution, and mixing. Porous bodies can also be produced through a foaming process in a container. The material is first aerated and foamed, distributing air throughout to create multiple cavities. This is then followed by low-temperature vacuum drying or direct drying to obtain the final low-water-content, hemispherical, porous body. Again, when encountering a solvent such as water, water is instantly drawn into these channels. The contact area between water and the porous body is extremely large, allowing for rapid penetration, dissolution, and mixing.

[0027] The binder is prepared through high-speed stirring and whipping or hot-melting mixing processes, and contains no water or has a moisture content controlled below 5%. The binder is non-flowing at room temperature. Through the whipping process, air is continuously incorporated under high-speed stirring, forming a stable foam system. Countless tiny air bubbles are encapsulated to form a three-dimensional network structure. When placed in the mouth or rubbed in the hands, it rapidly disintegrates under body temperature and pressure, quickly dissolving and mixing with saliva, water, etc., rather than slowly from the outside in, as is traditionally the case. The middle layer of the binder also has a certain degree of viscosity, bonding with the two outer porous layers to form a combined, fast-dissolving formulation. The viscosity of the binder can be derived from the oil itself, or it can be increased by adding sugars, etc.

[0028] Compared with the prior art, the combined instant dissolving formulation of the present invention is equivalent to splitting traditional freeze-dried balls along the central plane and then inserting an oil-containing adhesive to bond them together.

[0029] The combined instant-dissolving preparations described in this invention can be used in the fields of daily chemical personal care products or functional foods to make oral preparations (such as functional foods, pharmaceuticals or health products) or external preparations (bath balls, shampoo balls, skin balls).

[0030] Compared with the prior art, the outstanding effect of the present invention is as follows:

[0031] In addition to achieving rapid dissolution and ease of use, the combined instant-dissolving formulation of this invention, compared to traditional freeze-dried pellets, allows for a higher concentration of oils in its adhesive layer, thereby enhancing product efficacy. For example, in bath and skincare applications, the oils can deeply moisturize the skin, providing a protective barrier; in functional foods, pharmaceuticals, and health products, the oils can provide a better taste and also encapsulate some drug components, improving their stability.

[0032] The following description, in conjunction with the accompanying drawings and specific embodiments, further illustrates the combined instantaneous preparations, their preparation methods, and applications described in this invention. Attached Figure Description

[0033] Figure 1 This is a three-dimensional structural diagram of the combined instant-dissolving formulation of Example 1.

[0034] Figure 2 This is a schematic diagram of the structure of the combined instantaneous preparation of Example 1.

[0035] Figure 3 This is a three-dimensional structural diagram of the combined instant-dissolving formulation of Example 2.

[0036] Figure 4 This is a schematic diagram of the structure of the combined instantaneous preparation of Example 2.

[0037] Figure 5 The change in Erythema Index (EI) values ​​before and after sample use is shown. * indicates a statistically significant difference (p < 0.05) between the time before and after sample use.

[0038] Figure 6 The change in transepidermal water flow (TEWL) values ​​of the subjects' cheeks before and after sample use. ** indicates a statistically significant difference (p < 0.01) between the time before and after sample use.

[0039] Figure 7 The changes in skin lactic acid irritation scores before and after sample use are shown. * indicates a statistically significant difference (p < 0.05) between the time before and after sample use.

[0040] Among them, 1-loose porous body, 2-adhesive body. Detailed Implementation

[0041] Example 1: Macaron Shampoo and Shower Ball

[0042] like Figure 1-2As shown, a combined instant-dissolving formulation, namely a macaron shampoo and body shower ball, includes an outer layer and a middle layer. The outer layer is a low-water-content, instant-dissolving, loose, porous body 1, and there are two outer layers, located on either side of the middle layer. The middle layer is an oil-containing, instant-dissolving adhesive 2, located between and bonded to the two outer layers. Both outer layers are hemispherical, and the middle layer is positioned with a certain distance between the opposite surfaces of the two outer layers, making the middle layer visible.

[0043] The loose porous body 1 contains a binder, a skeleton support agent, and a surfactant. The specific weight ratio of each component is: polyvinyl alcohol 3%, mannitol 47%, sodium lauroyl glutamate 50% (the water content is not included in the above percentages, and the following examples and comparative examples are the same).

[0044] The weight ratio of the components of binder 2 is as follows: butter 80%, starch 8%, sodium lauroyl lactylate 12%. The weight ratio of the loose porous body to the binder is 4:1.

[0045] The specific preparation method of this macaron shampoo and body ball is as follows:

[0046] (1) Preparation of loose porous body: Polyvinyl alcohol raw material and deionized water are mixed at a weight ratio of 1:60, placed in a heating and stirring device, the heating temperature is controlled at 80℃ and the stirring speed is 20-50 rpm, and the stirring is continued for 30 minutes until the polyvinyl alcohol is completely dissolved and then cooled to room temperature to obtain a uniform polyvinyl alcohol solution.

[0047] Mannitol and sodium lauroyl glutamate are mixed evenly according to a preset ratio to obtain a mixed excipient; the mixed excipient is slowly added to the above-mentioned completely dissolved polyvinyl alcohol solution and stirred until the mixed excipient is completely dissolved to form a homogeneous and stable mixed system.

[0048] The above-mentioned mixed system is formed into a hemispherical blank using a quantitative molding equipment. The hemispherical blank is then dried. The drying method can be any one of freeze drying, vacuum drying, or oven drying. The blank is dried until the moisture content reaches the preset standard (4%), thus obtaining a loose porous body.

[0049] (2) Preparation of the binder: Place the butter raw material in a container and heat it at 50°C until the butter is completely softened;

[0050] Place the softened butter in a mixing bowl and beat it until it becomes smooth and fluffy.

[0051] Starch and sodium lauroyl lactylate are premixed evenly to form a premix; during the butter beating process, the premix is ​​added to the butter system in small batches and stirred until it is completely mixed to obtain the binder.

[0052] (3) Assembly: After the adhesive is heated and softened, it is uniformly coated on the hemispherical plane of one of the loose porous bodies prepared above;

[0053] Quickly align another loose, porous hemispherical blank with the hemisphere coated with adhesive to form a complete spherical structure;

[0054] After the assembled blank is left to stand, the adhesive is allowed to solidify and set, and the finished macaron shampoo and body shower ball is obtained.

[0055] In other beneficial embodiments, the structure can also be modified to a two-layer structure, namely: one layer is a loose porous body and the other layer is an adhesive.

[0056] Example 2 Macaron Shampoo and Shower Ball

[0057] like Figure 3-4 As shown, the main difference compared to Example 1 is that both outer layers are flat, and the weight ratio of the components of the loose porous body 1 is: hydroxypropyl starch 15%, β-cyclodextrin 40%, and potassium cocoyl glycinate 45%. The weight ratio of the components of the binder 2 is: hydrogenated vegetable oil 60%, glucose 15%, and sodium lauroyl sarcosinate 25%. The mass ratio of the loose porous body to the binder is 3:1.

[0058] The specific preparation method of this macaron bath bomb is as follows:

[0059] (1) Preparation of loose porous body: Hydroxypropyl starch raw material and deionized water are mixed at a weight ratio of 1:12, placed in a heating and stirring device, the heating temperature is controlled at 60℃ and the stirring speed is 20~50 rpm, and the stirring is continued for 5 minutes until the hydroxypropyl starch is completely dissolved and gelatinized to obtain a uniform hydroxypropyl starch solution.

[0060] β-cyclodextrin and potassium cocoyl glycinate are mixed evenly according to a preset ratio to obtain a mixed excipient; the mixed excipient is slowly added to the above-mentioned completely dissolved hydroxypropyl starch solution and stirred until the mixed excipient is completely dissolved to form a homogeneous and stable mixed system;

[0061] The above-mentioned mixed system is filled into a hemispherical blank using a quantitative molding equipment; the flat blank is dried, and the drying method can be any one of freeze drying, vacuum drying or oven drying, until the moisture content of the blank reaches the preset standard (3%), thus obtaining a loose porous body.

[0062] (2) Preparation of adhesive: Place the hydrogenated vegetable oil raw material in a container and heat it at 50°C until the hydrogenated vegetable oil is completely softened;

[0063] Place the softened hydrogenated vegetable oil in a mixing device and beat it until it has a uniform and fluffy texture.

[0064] Glucose and sodium lauroyl sarcosinate are premixed to form a premix; during the stirring and whipping of hydrogenated vegetable oil, the premix is ​​added to the hydrogenated vegetable oil system in small amounts in several batches, and stirring is continued until it is completely mixed to obtain the binder.

[0065] (3) Assembly: After the adhesive is softened by heating in water, it is evenly coated on the plane of one of the loose porous bodies prepared above;

[0066] Quickly align another loose, porous preform with the preform coated with the adhesive to form a complete flat structure;

[0067] After the assembled blank is left to stand, the adhesive is allowed to solidify and set, and the finished macaron shampoo and body shower ball is obtained.

[0068] In other beneficial embodiments, the structure can also be modified to a two-layer structure, namely: one layer is a loose porous body and the other layer is an adhesive.

[0069] Example 3 Food Balls

[0070] Compared with Example 1, the main difference is that the weight ratio of each component in the loose porous body 1 is: pullulan 3%, polyvinyl alcohol 3%, mannitol 49%, and ginseng extract 45%. The weight ratio of each component in the binder 2 is: butter 30%, starch 30%, fucoxanthin 20%, and coenzyme Q10 20%. The mass ratio of the loose porous body to the binder is 1:4.

[0071] The specific preparation method of this food ball is as follows:

[0072] (1) Preparation of loose porous body: Polyvinyl alcohol raw material and deionized water are mixed at a weight ratio of 1:60, placed in a heating and stirring device, the heating temperature is controlled at 80℃ and the stirring speed is 20~50 rpm, and the stirring is continued for 30 minutes until the polyvinyl alcohol is completely dissolved and then cooled to room temperature to obtain a uniform polyvinyl alcohol solution.

[0073] Pullulan, mannitol, and ginseng extract are mixed evenly according to a preset ratio to obtain a mixed excipient. The mixed excipient is then slowly added to the completely dissolved polyvinyl alcohol solution and stirred until the mixed excipient is completely dissolved to form a homogeneous and stable mixed system.

[0074] The above-mentioned mixed system is formed into a hemispherical blank using a quantitative molding equipment; the hemispherical blank is then dried, and the drying method can be any one of freeze drying, vacuum drying or oven drying, until the moisture content of the blank reaches the preset standard (3%), thus obtaining a loose porous body.

[0075] (2) Preparation of the binder: Place the butter raw material in a container and heat it at 50°C until the butter is completely softened;

[0076] Place the softened butter in a mixing bowl and beat it until it becomes smooth and fluffy.

[0077] Starch, fucoxanthin, and coenzyme Q10 are premixed to form a premix. During the butter beating process, the premix is ​​added to the butter system in small batches and stirred until it is completely mixed to obtain the binder.

[0078] (3) Assembly: After the adhesive is softened by heating in water, it is evenly coated on the hemispherical plane of one of the loose porous bodies prepared above;

[0079] Quickly align and press another loose, porous hemispherical blank with the hemisphere coated with adhesive to form a complete spherical structure;

[0080] The assembled blank is placed in a constant temperature and humidity environment and left to stand until the adhesive solidifies and sets, thus obtaining the finished food ball.

[0081] In other beneficial embodiments, a five-layer structure can also be adopted, namely, from bottom to top: a layer of loose porous body, a layer of adhesive, a layer of loose porous body, a layer of adhesive, and a layer of loose porous body.

[0082] Example 4 Food Balls

[0083] Compared with Example 3, the main difference is that the weight ratio of each component in the loose porous body 1 is: xanthan gum 5%, trehalose 35%, and astragalus extract 60%. The weight ratio of each component in the binder 2 is: hydrogenated vegetable oil 10%, sucrose 55%, and fish oil 35%. The mass ratio of the loose porous body to the binder is 1:2.

[0084] The specific preparation method of this food ball is as follows:

[0085] (1) Preparation of loose porous body: Xanthan gum raw material and deionized water are mixed at a weight ratio of 1:40, and stirred at a stirring speed of 20~50 rpm for 30 minutes until the xanthan gum is completely dissolved to obtain a uniform xanthan gum solution.

[0086] Trehalose and astragalus extract are mixed evenly according to a preset ratio to obtain a mixed excipient; the mixed excipient is slowly added to the above-mentioned completely dissolved xanthan gum solution, and the mixture is stirred and homogenized until the mixed excipient is completely dissolved to form a homogeneous and stable mixed system.

[0087] The above-mentioned mixed system is made into a hemispherical blank using a quantitative canning molding equipment; the hemispherical blank is dried, and the drying method can be any one of freeze drying, vacuum drying or oven drying, until the moisture content of the blank reaches the preset standard (4%), thus obtaining a loose porous body.

[0088] (2) Preparation of adhesive: Place the hydrogenated vegetable oil raw material in a container and heat it at 50°C until the hydrogenated vegetable oil is completely softened;

[0089] Place the softened hydrogenated vegetable oil in a mixing device and beat it until it has a uniform and fluffy texture.

[0090] Sugar and fish oil are premixed evenly to form a premix; during the stirring and whipping of hydrogenated vegetable oil, the premix is ​​added to the hydrogenated vegetable oil system in small amounts in several batches, and stirring is continued until it is completely mixed and homogeneous to obtain the binder.

[0091] (3) Assembly: After the adhesive is heated to 50°C to soften it, it is evenly coated on the hemispherical plane of one of the loose porous bodies prepared above;

[0092] Quickly align another loose, porous hemispherical blank with the hemisphere coated with adhesive to form a complete spherical structure;

[0093] The assembled blank is left to stand until the adhesive has solidified and set, thus obtaining the finished food ball.

[0094] In other beneficial embodiments, the structure can also be modified to a two-layer structure, namely: one layer is a loose porous body and the other layer is an adhesive.

[0095] Example 5: Skin Care Balls

[0096] Compared with Example 1, the main difference is that the weight ratio of each component in the loose porous body 1 is: gelatin 9%, mannitol 90%, and vitamin C 1%. The weight ratio of each component in the binder 2 is: petrolatum 60%, microcrystalline cellulose 20%, and coenzyme Q10 20%. The mass ratio of the loose porous body to the binder is 3:1.

[0097] The specific preparation method for this skincare ball is as follows:

[0098] (1) Preparation of loose porous body: Mix gelatin raw material with deionized water at a weight ratio of 1:20, place it in a heating environment, control the temperature at 60℃, and cool it down to room temperature after the gelatin is completely dissolved to obtain a uniform gelatin solution.

[0099] Mannitol and vitamin C are mixed evenly according to a preset ratio to obtain a mixed excipient; the mixed excipient is slowly added to the above-mentioned completely dissolved gelatin solution and stirred until the mixed excipient is completely dissolved to form a homogeneous and stable mixed system.

[0100] The above-mentioned mixed system is quantitatively filled into a mold to form a hemispherical blank. The hemispherical blank is then dried. The drying method can be any one of freeze-drying, vacuum drying, or oven drying. The blank is dried until the moisture content reaches the preset standard, thus obtaining a loose porous body with a moisture content of 3% and a water activity (Aw) ≤ 0.60. It is completely dissolved, free of foreign matter, and free of turbidity.

[0101] (2) Preparation of adhesive: Place the petrolatum raw material in a container and heat it at 50°C until the petrolatum is completely softened;

[0102] Place the softened petroleum jelly in a mixing bowl and beat it until it becomes smooth and fluffy.

[0103] Microcrystalline cellulose and coenzyme Q10 are premixed evenly to form a premix; during the stirring and whipping of petroleum jelly, the premix is ​​added to the petroleum jelly system in small amounts in batches, and stirring is continued until it is completely mixed and homogeneous to obtain the adhesive.

[0104] (3) Assembly: After the adhesive is heated to 50°C to soften it, it is evenly coated on the hemispherical plane of one of the loose porous bodies prepared above;

[0105] Quickly align another loose, porous hemispherical blank with the hemisphere coated with adhesive to form a complete spherical structure;

[0106] The assembled blank is left to stand until the adhesive has cured and set, thus obtaining the finished skincare ball.

[0107] In other beneficial embodiments, a four-layer structure can also be adopted, namely, from bottom to top: a layer of loose porous body, a layer of adhesive, a layer of loose porous body, and a layer of adhesive.

[0108] Example 6: Skin Care Balls

[0109] Compared with Example 5, the main difference is that the weight ratio of each component in the loose porous body 1 is: 10% carbomer, 80% mannitol, and 10% glycyrrhizin. The weight ratio of each component in the binder 2 is: 54% coconut oil, 45% starch dextrin, and 1% lycopene. The mass ratio of the loose porous body to the binder is 1:2.

[0110] The specific preparation method for this skincare ball is as follows:

[0111] (1) Preparation of loose porous body: Carbomer raw material and deionized water are mixed at a weight ratio of 1:20 and stirred until the carbomer is completely dissolved to obtain a uniform carbomer solution.

[0112] Mannitol and glycyrrhizin are mixed evenly according to a preset ratio to obtain a mixed excipient; the mixed excipient is slowly added to the above-mentioned completely dissolved carbomer solution and stirred until the mixed excipient is completely dissolved to form a homogeneous and stable mixed system.

[0113] The above-mentioned mixed system is formed by quantitative molding equipment by filling into a mold to form a hemispherical blank; the hemispherical blank is dried by any of the following methods: freeze drying, vacuum drying or oven drying, until the moisture content of the blank reaches the preset standard, thus obtaining a loose porous body with a moisture content of 4%.

[0114] (2) Preparation of binder: Place the coconut oil raw material in a container and heat it at 50°C until the coconut oil is completely softened; place the softened coconut oil in a stirring device and stir and beat it to make it uniform and fluffy.

[0115] Starch dextrin and lycopene are premixed evenly to form a premix; during the whipping of coconut oil, the premix is ​​added to the coconut oil system in small amounts in batches, and the mixture is continuously stirred until it is completely mixed to obtain the binder.

[0116] (3) Assembly: After heating and softening the adhesive, it is uniformly coated on the hemispherical plane of one of the loose porous bodies prepared above; the hemispherical blank of the other loose porous body is quickly joined with the hemispherical blank coated with adhesive to form a complete spherical structure; the assembled blank is placed in a constant temperature and humidity environment and left to stand until the adhesive is cured and shaped to obtain the skin care ball finished product.

[0117] In other beneficial embodiments, the structure can also be modified to a two-layer structure, namely: one layer is a loose porous body and the other layer is an adhesive.

[0118] Example 7 Food Balls (the adhesive is made from whipped oil)

[0119] Compared with Example 4, the main difference is that the weight ratio of each component in the loose porous body 1 is: starch 20%, trehalose 35%, sialic acid 10%, and mannitol 35%. The weight ratio of each component in the binder 2 is: butter 86%, DHA algal oil 10%, walnut oil 2%, and fish oil 2%. The mass ratio of the loose porous body to the binder is 2:1.

[0120] The specific preparation method of this food ball is as follows:

[0121] (1) Preparation of loose porous body: Mix starch raw material with deionized water at a weight ratio of 1:10, place it in a stirring position of 20~50 rpm, and stir continuously for 30 minutes until the starch is completely dissolved to obtain a uniform starch solution;

[0122] Trehalose, sialic acid, and mannitol are mixed evenly according to a preset ratio to obtain a mixed excipient; the mixed excipient is slowly added to the above-mentioned completely dissolved starch solution, and the mixture is stirred and homogenized until the mixed excipient is completely dissolved to form a homogeneous and stable mixed system.

[0123] The above-mentioned mixed system is made into a hemispherical preform using a quantitative canning molding equipment; the hemispherical preform is then dried, and the drying method can be any one of freeze drying, vacuum drying or oven drying, until the moisture content of the preform reaches the preset standard, thus obtaining a loose porous body with a moisture content of 5%.

[0124] (2) Preparation of the binder: Place the butter raw material in a container and heat it at 50°C until the butter is completely softened;

[0125] Place the softened butter in a mixing bowl and beat it until it is evenly fluffy and aerated.

[0126] DHA algal oil, fish oil, and walnut oil are premixed evenly to form a premix. During the butter beating process, the premix is ​​added to the butter system in small batches, and the mixture is continuously stirred, aerated, and beaten until it is completely mixed to obtain the binder.

[0127] (3) Assembly: The adhesive is quantitatively filled onto the hemispherical plane of one of the loose porous bodies prepared above; the hemispherical blank of the other loose porous body is quickly assembled with the hemispherical blank coated with adhesive to form a complete spherical structure; the assembled blank is left to stand until the adhesive is cured and shaped to obtain the finished food ball.

[0128] In other beneficial embodiments, the structure can also be modified to a two-layer structure, namely: one layer is a loose porous body and the other layer is an adhesive.

[0129] Example 8: Skin care product ball (the adhesive is made of unwhipped oil)

[0130] Compared with Example 5, the differences include: the weight ratio of each component in the loose porous body 1 is: pullulan 5%, mannitol 80%, starch 10%, and centella asiatica extract 5%. The weight ratio of each component in the binder 2 is: shea butter 90%, squalane 5%, vitamin E 2%, and grape seed oil 3%. The mass ratio of the loose porous body to the binder is 2:1.

[0131] The specific preparation method for this skincare ball is as follows:

[0132] (1) Preparation of loose porous body: Mix pullulan polysaccharide raw material with deionized water at a weight ratio of 1:30, place it under stirring until pullulan polysaccharide dissolves, and obtain a uniform pullulan polysaccharide solution;

[0133] Mannitol, starch, and Centella asiatica extract are mixed evenly according to a preset ratio to obtain a mixed excipient; the mixed excipient is slowly added to the above-mentioned completely dissolved pullulan polysaccharide solution, and stirring is continued until the mixed excipient is completely dissolved to form a homogeneous and stable mixed system.

[0134] The above-mentioned mixed system is formed by quantitative molding equipment by filling into a mold to form a hemispherical blank; the hemispherical blank is dried by any of the following methods: freeze drying, vacuum drying or oven drying, until the moisture content of the blank reaches the preset standard, thus obtaining a loose porous body with a moisture content of 4%.

[0135] (2) Preparation of adhesive: Shea butter raw material is placed in a container and heated at 50°C until the shea butter is completely softened; the softened shea butter is placed in a stirring device; squalane, vitamin E and grape seed oil are premixed evenly to make a premix; during the stirring of coconut oil, the premix is ​​added to the shea butter system in small amounts in batches and stirred continuously until it is completely mixed evenly to obtain the adhesive.

[0136] (3) Assembly: After the adhesive is heated and softened, it is uniformly coated on the hemispherical plane of one of the loose porous bodies prepared above;

[0137] Quickly align another loose, porous hemispherical blank with the hemisphere coated with adhesive to form a complete spherical structure;

[0138] The assembled blank is placed in a constant temperature and humidity environment and left to stand until the adhesive solidifies and sets, thus obtaining the finished skin care ball.

[0139] In other beneficial embodiments, the structure can also be modified to a two-layer structure, namely: one layer is a loose porous body and the other layer is an adhesive.

[0140] To highlight the beneficial effects of the present invention, the following comparative experiments are provided.

[0141] Comparative Example 1: Traditional freeze-dried balls

[0142] Compared with Example 1, the difference is that the middle layer is removed, and only the two outer layers are retained, while the rest remain unchanged.

[0143] The specific preparation method is as follows:

[0144] (1) Preparation of loose porous body: Polyvinyl alcohol raw material and deionized water are mixed in a preset ratio, placed in a heating and stirring device, the heating temperature is controlled at 80℃ and the stirring speed is 20-50 rpm, and the stirring is continued for 30 minutes until the polyvinyl alcohol is completely dissolved and then cooled to room temperature to obtain a uniform polyvinyl alcohol solution.

[0145] Pullulan, mannitol, and sodium lauroyl glutamate are mixed evenly according to a preset ratio to obtain a mixed excipient. The mixed excipient is slowly added to the above-mentioned completely dissolved polyvinyl alcohol solution and stirred until the mixed excipient is completely dissolved to form a homogeneous and stable mixed system.

[0146] The prepared mixture is filled into a hemispherical mold using a quantitative filling device;

[0147] The above-mentioned mixed system is formed into a hemispherical blank using a quantitative molding equipment; the hemispherical blank is then freeze-dried (any one of freeze-drying, vacuum drying or oven drying can be used) until the moisture content of the blank reaches the preset standard (4%), thus obtaining a loose porous body.

[0148] (2) Assembly: A loose, porous hemispherical blank is joined and pressed with another hemispherical blank to form a complete spherical structure;

[0149] The assembled blank is placed in a constant temperature and humidity environment and left to stand until the adhesive has cured and set, thus obtaining the finished product.

[0150] Comparative Example 2

[0151] Compared with Example 1, the difference is that the adhesive is prepared by a direct melt-mixing process, while the rest remains unchanged.

[0152] The specific preparation method is as follows:

[0153] (1) Preparation of loose porous body: exactly the same as in Example 1.

[0154] (2) Preparation of binder: Place the butter raw material in a container and heat it at 50°C until it is completely melted into a liquid state; mix the starch and sodium lauroyl lactylate evenly in advance to make a premix; add the premix to the completely melted butter at once or in batches, and use mechanical stirring at low speed (20 rpm) to simply mix, ensuring that the premix is ​​completely wetted and coated with butter to form a uniform melt mixture; Note: No whipping is performed in this process, no air is introduced, and the mixture is a dense, continuous oily paste.

[0155] (3) Assembly: While the adhesive is still hot (keeping it in a fluid state), it is evenly coated onto the hemispherical plane of one of the loose porous bodies prepared above; the hemispherical blank of the other loose porous body is quickly aligned and pressed with the hemispherical blank coated with adhesive to form a complete spherical structure; the assembled blank is placed in a constant temperature and humidity environment and left to stand until the adhesive cools and solidifies to obtain the finished product.

[0156] Example 9

[0157] The product of Example 1 and the products of Comparative Examples 1-2 were subjected to performance tests, and the results are shown below.

[0158]

[0159] Further clinical verification of the oil control and dandruff removal effects of the macaron shampoo and body shower ball from Example 1 was conducted. The experimental process and results are as follows.

[0160] 1. Experimental Objective

[0161] By recruiting volunteers to conduct home trials, we collected consumers' actual usage experiences and evaluations of the Macaron Shampoo and Body Balls, verifying their efficacy in controlling oil, removing dandruff, and relieving itching in real-life scenarios, as well as product satisfaction.

[0162] 2. Test Methods

[0163] 2.1 Subject Screening

[0164] One hundred volunteers were recruited who met the following criteria: aged 18-50, male or female; reported severe scalp oiliness (obviously oily within 24 hours after washing their hair); reported significant dandruff problems; had not used professional anti-dandruff medications or functional shampoos in the past month; had no serious scalp diseases or history of shampoo allergies; and were willing to participate and sign an informed consent form.

[0165] 2.2 Test Materials

[0166] Experimental group: The oil-controlling and dandruff-reducing shampoo ball prepared in Example 1 of this invention. Control group: Commercially available ordinary refreshing shampoo (without specific dandruff-reducing ingredients).

[0167] 2.3 Experimental Design

[0168] A randomized, double-blind, parallel-controlled design was used, in which 100 participants were randomly assigned to two groups of 50 each.

[0169] Experimental group: using the shampoo ball of this invention; Control group: using commercially available ordinary shampoo.

[0170] 2.4 Usage

[0171] Shampooing frequency: Use once every other day, about 3 times a week; How to use: Take one shampoo ball, add water and rub to create lather, then apply to wet hair and scalp, gently massage for 2-3 minutes, and rinse thoroughly with water; Trial period: Use continuously for 28 days.

[0172] 2.5 Evaluation Method

[0173] Subjective evaluations were collected from participants using a questionnaire survey method before use, 14 days after use, and 28 days after use. Statistical analysis was performed using a 5-point rating scale (1 point = very dissatisfied / no improvement at all, 5 points = very satisfied / significant improvement) or by percentage selection.

[0174] 3. Evaluation Indicators

[0175] Participants evaluated the following indicators using a questionnaire:

[0176] Oil control effect: how long the scalp feels clean after washing, and the rate of oil production.

[0177] Dandruff removal effect: changes in the amount of dandruff, and the degree of dandruff visibility.

[0178] Anti-itch effect: Degree of improvement in scalp itching

[0179] Hair feel: Fluidity, smoothness, and cleanliness of hair after washing

[0180] Product user experience: lathering ability, ease of rinsing, and whether the skin feels dry and tight after washing.

[0181] Overall satisfaction: Would you be willing to continue using it? Would you be willing to recommend it to others?

[0182] 4. Test Results

[0183] Basic information of the participants: A total of 100 participants completed the entire experiment, with 50 participants in each group. Among them, there were 42 males and 58 females, with an average age of 29.6 years. There were no significant differences between the two groups in terms of age, gender, and scalp condition.

[0184] 5. Results Statistics

[0185] 5.1 Evaluation of oil control effect: After 28 days of use, the subjects' evaluation of the product's oil control effect is shown in the table below.

[0186]

[0187] Results analysis: 64% of the subjects in the experimental group reported that their hair remained fresh for more than 24 hours after washing, which was significantly higher than 16% in the control group; 90% of the subjects believed that the oil control effect of the shampoo ball of the present invention was significantly improved, indicating that the product has excellent oil control durability.

[0188] 5.2 Evaluation of dandruff removal effect: The subjects' evaluation of the improvement in dandruff is shown in the table below.

[0189]

[0190] Results analysis: After 28 days of use, 88% of the subjects in the experimental group reported a significant reduction in dandruff, compared to only 30% in the control group. Furthermore, the effect in the experimental group increased with prolonged use (from 76% at 14 days to 88% at 28 days), indicating that the shampoo ball of this invention has a continuously enhanced dandruff-removing effect.

[0191] 5.3 Evaluation of antipruritic effect: The improvement of scalp itching is shown in the table below.

[0192]

[0193] Results analysis: 80% of the subjects in the experimental group reported significant improvement in scalp itching, and 86% of the subjects felt relief from itching within one week of use, indicating that the shampoo ball of the present invention has a rapid anti-itch effect.

[0194] 5.4 Hair feel evaluation: The evaluation of hair condition after washing is shown in the table below.

[0195]

[0196] Results analysis: 76% of the subjects in the experimental group reported that their hair was noticeably more voluminous after washing, and 82% reported that their hair was not dry after washing, indicating that the shampoo ball of the present invention is gentle on the hair while controlling oil and does not damage the hair.

[0197] 5.5 Product Usage Experience Evaluation: The product usage experience evaluation is shown in the table below.

[0198]

[0199] Results analysis: The subjects gave high ratings to the shampoo ball of the present invention. The satisfaction rate in terms of foaming degree, easy rinsing and fragrance all exceeded 90%. In particular, the novel form of the product was highly recognized by 90% of the subjects.

[0200] 5.6 Overall Satisfaction: The overall evaluation after 28 days of use is shown in the table below.

[0201]

[0202] Results analysis: The overall satisfaction rate of the experimental group reached 96% (very satisfied + satisfied), 92% of the subjects expressed their willingness to continue using it, and 90% were willing to recommend it to others, indicating that the shampoo ball of this invention has gained high recognition from consumers.

[0203] 6. Safety Feedback: No adverse reactions such as scalp redness, stinging, or hair loss were reported during the trial. The product is generally mild.

[0204] 7. Experimental Conclusion: Based on the home trial evaluation of 100 consumers, the oil-controlling and dandruff-reducing shampoo ball described in this invention yielded the following conclusions:

[0205] Significant oil control effect: 64% of the subjects felt refreshed for more than 24 hours after washing, and 90% believed that the oil control effect was significantly improved.

[0206] Outstanding dandruff-reducing effect: 88% of the subjects experienced a significant reduction in dandruff after 28 days of use, and the effect increased with the duration of use.

[0207] Rapid relief from itching: 80% of the subjects experienced significant improvement in itching, and 86% felt relief within one week of use.

[0208] Improved hair texture: 76% of the subjects reported that their hair was noticeably more voluminous after washing, and 82% reported that their hair was not dry after washing.

[0209] The product experience was excellent: satisfaction rates for indicators such as foaming ability, ease of rinsing, and fragrance all exceeded 90%.

[0210] High consumer approval rating: Overall satisfaction rate is 96%, 92% are willing to continue using the product, and 90% are willing to recommend it to others.

[0211] In summary, the macaron shampoo and body shower ball of the present invention has excellent oil control, dandruff removal, and itch relief effects in real-world usage scenarios, provides a good user experience, has gained high recognition from consumers, and has good market application prospects.

[0212] Example 10

[0213] Compared with traditional dried / baked foods and fried / puffed foods, the food balls of this application have the following advantages:

[0214]

[0215] The food balls from Example 3 were subjected to a clinical trial investigation. The trial process and results are as follows.

[0216] 1. Purpose of the survey

[0217] By conducting a consumer home trial survey of the weight loss freeze-dried balls described in this invention, information such as changes in weight, body circumference, satiety experience, changes in eating habits, and overall satisfaction of real users during use was collected to verify its auxiliary weight loss effect and product acceptance in daily life scenarios.

[0218] 2. Survey Methodology

[0219] 2.1 Subject Recruitment

[0220] We will recruit 120 volunteer participants through online platforms and offline channels. The selection criteria are as follows: age 20-50 years old, gender not limited; body mass index (BMI) ≥24kg / m² (overweight or obese standard); clear weight loss needs, with stable weight (fluctuation ≤2kg) in the past 3 months; no serious digestive system diseases, metabolic diseases (such as diabetes, thyroid dysfunction), or cardiovascular and cerebrovascular diseases; not pregnant or breastfeeding women; no history of food allergies, especially no allergies to the ingredients contained in the product (such as protein, dietary fiber, etc.); voluntary participation and signing of an informed consent form, promising to use the product as required and cooperate with data recording.

[0221] 2.2 Experimental Grouping

[0222] A randomized, double-blind, placebo-controlled design was used, and 120 participants were randomly assigned to two groups of 60 each.

[0223] Experimental group: Food balls prepared using Example 3 of this invention;

[0224] Control group: Placebo food balls (containing no active weight loss ingredients) with similar appearance and taste.

[0225] 2.3 Usage Method

[0226] Directions for use: Take one capsule twice daily, morning and evening, 30 minutes before meals. No water is needed; simply place the capsule in your mouth to absorb.

[0227] Consumption period: Consume continuously for 8 weeks (56 days).

[0228] Dietary recommendations: Maintain your usual eating habits and do not deliberately diet, but it is recommended to avoid overeating.

[0229] Lifestyle: No additional exercise is required; maintain existing lifestyle habits.

[0230] 2.4 Data Collection Methods

[0231] Adopting a "3+1" data collection model:

[0232] Baseline survey (before use): Collect basic information, height and weight, body circumference, dietary habits, etc.

[0233] Mid-term survey (after 4 weeks of use): Collect data on weight changes, satiety assessments, product acceptance, etc.

[0234] Final survey (after 8 weeks of use): Collect comprehensive data, including weight, measurements, satisfaction, etc.

[0235] Daily record (optional): Participants voluntarily record their daily eating sensations, hunger levels, etc.

[0236] 2.5 Evaluation Indicators

[0237] The method combines a 5-point scoring system, percentage statistics, and specific numerical changes.

[0238]

[0239] 3. Data Statistics: SPSS software was used for data analysis. Paired t-tests were used for within-group comparisons, independent samples t-tests were used for between-group comparisons, and chi-square tests were used for count data. The significance level was set at P < 0.05 (significant) and P < 0.01 (highly significant).

[0240] 4. Survey Results

[0241] Basic information of the participants: A total of 120 participants were enrolled, of whom 115 completed the entire 8-week trial (58 in the experimental group and 57 in the control group), and 5 withdrew midway due to personal reasons. Among the participants who completed the trial, there were 48 males and 67 females, with a mean age of 34.2 years and a mean BMI of 27.6 kg / m². 2 There were no statistically significant differences between the two groups in terms of age, sex, and baseline weight (P > 0.05).

[0242] 5. Results Statistics

[0243] 5.1 Weight changes: The weight changes of the subjects after 8 weeks of use are shown in Table 1.

[0244] Table 1 Comparison of weight changes before and after use (xˉ±s)

[0245]

[0246] Note: Compared with before use, *P<0.05, **P<0.01; compared with after 4 weeks of use, ##P<0.01.

[0247] Results analysis: After 8 weeks of use, the experimental group achieved an average weight loss of 7.36 kg, representing a weight loss rate of 9.86%, which was significantly better than the control group's 1.97 kg (P < 0.01). The weight loss effect in the experimental group increased with the duration of use (3.43 kg in 4 weeks and another 3.93 kg in 8 weeks), indicating that the freeze-dried pellets of this invention have a sustained and stable weight loss effect.

[0248] 5.2 Distribution of weight loss effect: The distribution of weight loss effect of the subjects in the experimental group is shown in Table 2.

[0249] Table 2. Distribution of weight loss effects in the experimental groups (n=58)

[0250]

[0251] Results analysis: 75.9% of the subjects in the experimental group lost more than 5 kg, and 20.7% of the subjects lost more than 10 kg, indicating that the product of this invention has a significant weight loss effect on most users.

[0252] 5.3 Changes in body circumference: The changes in body circumference of the subjects in the experimental group are shown in Table 3.

[0253] Table 3. Changes in body circumference before and after use in the experimental group (xˉ±s, unit: cm)

[0254]

[0255] Note: Compared with before use, **P < 0.01.

[0256] Results analysis: The average waist circumference of the subjects in the experimental group decreased by 8.77 cm, and the waist-to-hip ratio decreased significantly (P<0.01), indicating that the product of this invention has a good effect on reducing abdominal fat and helps to improve body shape.

[0257] 5.4 Satiety and Appetite Control Evaluation: The subjects' evaluation of satiety and appetite control is shown in Table 4.

[0258] Table 4. Evaluation results of satiety and appetite control

[0259] (On a 5-point scale, 1 point = very poor / absolutely not good, 5 points = very good / very obvious)

[0260]

[0261] Results analysis: The experimental group was significantly better than the control group in terms of satiety and appetite control (P<0.01), indicating that the freeze-dried ball food of the present invention can effectively increase satiety, reduce the amount of food consumed at regular meals, and suppress the desire for snacks, thus helping to control calorie intake from the source.

[0262] 5.5 Analysis of satiety duration: The distribution of satiety duration after the subjects in the experimental group consumed the product is shown in Table 5.

[0263] Table 5. Duration of satiety in the experimental group (n=58)

[0264]

[0265] Results analysis: 75.9% of the participants in the experimental group reported that the feeling of fullness could last for more than 3 hours, which was enough to cover the interval between meals and effectively avoid the intake of snacks and extra meals.

[0266] 5.6 Energy perception and mental state: The subjects' evaluation of their energy perception after consumption is shown in Table 6.

[0267] Table 6. Energy Perception Evaluation Results (out of 5)

[0268]

[0269] Note: The lower the fatigue score, the less fatigued you are.

[0270] Results analysis: The subjects in the experimental group did not experience significant fatigue during the weight loss process, and their mental state and daily activity energy scores were significantly better than those in the control group (P<0.01), indicating that the product of this invention can maintain a good energy level while reducing calorie intake and avoid fatigue caused by dieting.

[0271] 5.7 Improvement in defecation: The subjects' evaluation of their defecation is shown in Table 7.

[0272] Table 7 Evaluation of Improvement in Bowel Movements (out of 5)

[0273]

[0274] Results analysis: The experimental group showed significant improvement in bowel regularity and smoothness (P<0.01), indicating that the dietary fiber in the product helps promote intestinal peristalsis and improve constipation.

[0275] 5.8 Product usage experience evaluation: The subjects' evaluation of the product itself is shown in Table 8.

[0276] Table 8 Product User Experience Evaluation (out of 5)

[0277]

[0278] Results analysis: The product received high scores in all user experience indicators, especially in portability (4.72) and ease of consumption (4.66), which were highly recognized, indicating that the freeze-dried ball form has obvious advantages and is suitable for the fast-paced lifestyle of modern people.

[0279] 5.9 Overall satisfaction evaluation: After 8 weeks of use, the overall satisfaction evaluation of the subjects is shown in Table 9.

[0280] Table 9 Overall Satisfaction Evaluation

[0281]

[0282] Results analysis: The overall satisfaction score of the experimental group was 4.42 out of 5. 88.0% of the subjects believed that the weight loss target was met or exceeded, 87.9% were willing to continue using the product, and 84.5% were willing to recommend it to others, indicating that the product of this invention has gained high recognition from consumers.

[0283] 6. Safety Feedback: During the trial, four participants in the experimental group reported mild abdominal bloating initially (two of whom also experienced increased flatulence), which subsided spontaneously after 3-5 days of continued consumption; one participant reported mild diarrhea, which disappeared after adjusting the consumption method (to take after meals). No serious adverse events were reported. All participants' blood routine tests, liver and kidney function, and other safety indicators were within the normal range.

[0284] 7. Survey Conclusion: Based on an 8-week home trial survey of 120 consumers, the following conclusions were reached regarding the weight-loss freeze-dried balls described in this invention:

[0285] 7.1 Significant weight loss effect

[0286] The average weight loss was 7.36 kg, representing a weight loss rate of 9.86%; 75.9% of the participants lost more than 5 kg, and 20.7% lost more than 10 kg; the average waist circumference decreased by 8.77 cm, and the waist-to-hip ratio improved significantly.

[0287] 7.2 Strong feeling of fullness, naturally controlling food intake

[0288] The satiety score after consuming the product before meals was 4.32 out of 5; 75.9% of the participants felt full for more than 3 hours; it effectively reduced the amount of food consumed at main meals and suppressed the desire for snacks.

[0289] 7.3 Abundant energy, no feeling of fatigue

[0290] During the weight loss process, the participants maintained a good mental state and experienced no typical dieting fatigue; their daily activity energy scores were significantly better than the control group.

[0291] 7.4 Improves bowel movements and promotes gut health

[0292] Bowel regularity and ease of defecation are significantly improved; dietary fiber plays a positive role.

[0293] 7.5 Excellent product experience and high acceptance.

[0294] The freeze-dried pellet form received high praise, with a portability score of 4.72; the taste, solubility, and other user experience indicators all received high scores.

[0295] 7.6 High consumer acceptance

[0296] Overall satisfaction score was 4.42 out of 5; 88.0% of participants achieved or exceeded their weight loss expectations; 87.9% were willing to continue using the product, and 84.5% were willing to recommend it to others.

[0297] In summary, the food balls of this invention have significant weight-loss aid effects in real-life scenarios, effectively increasing satiety, controlling appetite, promoting bowel movements, and maintaining good mental state and energy levels. The product has a novel form, is easy to use, and tastes good, gaining widespread consumer recognition and possessing promising market application prospects.

[0298] Example 11

[0299] Compared with traditional skincare products (lotions / serums / creams), the skincare spheres of this application have the following advantages:

[0300]

[0301] The skincare product balls from Example 5 were subjected to a human efficacy evaluation test. The test process and results are as follows.

[0302] 1. Experimental Objective

[0303] Human efficacy evaluation tests were conducted on the soothing skin care ball described in this invention to verify its soothing effect on improving symptoms such as erythema, dryness, tightness, stinging and itching of sensitive skin, and to evaluate its skin barrier repair ability and anti-irritation ability under real use conditions.

[0304] 2. Experimental Basis and Principles

[0305] This experiment followed the basic principles of the Declaration of Helsinki and referenced T / GDCDC 021-2022 "Test Method for Soothing Efficacy of Cosmetics" and T / GDCA 038-2024 "Human Evaluation Method for Soothing Efficacy of Cosmetics".

[0306] Inclusion criteria: Healthy subjects aged 18-60 years with no serious systemic diseases, no history of immunodeficiency or immunosuppression, who voluntarily participated in the trial and signed an informed consent form were selected.

[0307] Exclusion criteria: Individuals who have used antihistamines within the past week or immunosuppressants within the past month; individuals with skin diseases such as eczema or psoriasis at the test site; women who are pregnant, breastfeeding, or planning to conceive; and individuals with a highly allergic constitution.

[0308] 3. Experimental Design

[0309] This experiment uses a self-controlled before-and-after experimental design.

[0310] Sample size: At least 30 valid subjects were included.

[0311] Environmental conditions: The ambient temperature was controlled at (21±1)℃ and the relative humidity was (50±5)% RH, and real-time monitoring was carried out.

[0312] Usage: Subjects used the skin care ball prepared in Example 1 of this invention for skin care after cleansing their face every morning and evening for 28 days.

[0313] 4. Testing Methods and Evaluation Indicators

[0314] Screening tests based on the lactic acid stinging model (applicable to products that claim to quickly relieve stinging and improve sensitivity).

[0315] This plan references T / BDCA 0005-2023 "Test Method for Human Lactic Acid Stinging Test on Soothing Efficacy of Cosmetics".

[0316] Screening period: Lactic acid stinging was screened using a 10% lactic acid solution. The trial was conducted on sensitive individuals who passed the screening (visual analog scale score of lactic acid stinging ≥3 points).

[0317] Testing period: Follow-up visits were conducted before use (D0) and 7 days after use.

[0318] Evaluation indicators:

[0319] Subjective rating: Subjects rated the stinging sensation in the nasolabial fold area on a 4-point scale based on the degree of stimulation they felt (0 points - no stinging sensation, 1 point - mild stinging sensation, 2 points - moderate stinging sensation, 3 points - severe stinging sensation).

[0320] Instrumental testing: Transepidermal water loss (TEWL) values ​​were measured using a Tewameter TM300 to assess skin barrier function; the erythema index (EI) was measured using a Mexameter MX18 to assess the degree of skin redness.

[0321] Experimental results:

[0322] (1) Erythema Index (EI) value

[0323] As shown in Tables 1-1, 1-2 and Figure 5 As shown, after 7 days of sample use, the EI value of the skin erythema decreased by 6.82% (p<0.05), and there was a significant difference in the EI value of the skin erythema before and after the subjects used the sample.

[0324] Table 1-1 Descriptive statistics of Erythema Index (EI) values ​​before and after sample use.

[0325]

[0326] Note: The Shapiro-Wilk test has a significance value > 0.05 for normality testing, and the difference before and after the test follows a normal distribution.

[0327] Table 1-2 Analysis of the differences in Erythema Index (EI) values ​​before and after sample use.

[0328]

[0329] Notes: 1. Rate of change = [(after sample use - before sample use) / before sample use] × 100%. 2. Significant difference: P < 0.05; No significant difference: P ≥ 0.05. 3. * indicates that the two groups of data were compared using a paired t-test; ** indicates that the two groups of data were compared using a rank-sum test.

[0330] (2) Transepidermal flow rate (TEWL) value

[0331] As shown in Tables 2-1, 2-2 and Figure 6 As shown, after 7 days of sample use, the transepidermal water flow (TEWL) value of the subject's cheek decreased by 15.93% (p < 0.01), and the difference in transepidermal water flow (TEWL) value of the cheek before and after sample use was highly significant.

[0332] Table 2-1 Descriptive statistics of transdermal water flow TEWL values ​​before and after sample use

[0333]

[0334] Note: The Shapiro-Wilk test has a significance value of <0.05 for normality, indicating that the difference before and after the test does not follow a normal distribution.

[0335] Table 2-2 Analysis of the differences in TEWL values ​​of transdermal water flow before and after sample use

[0336]

[0337] Notes: 1. Rate of change = [(after sample use - before sample use) / before sample use] × 100%. 2. Significant difference: P < 0.05; No significant difference: P ≥ 0.05. 3. * indicates that the two groups of data were compared using a paired t-test; ** indicates that the two groups of data were compared using a rank-sum test.

[0338] (3) Results of lactic acid stimulation test

[0339] As shown in Tables 3-1, 3-2 and Figure 3 As shown, after 7 days of sample use, the subjects' lactate stimulation scores decreased by 75% (p<0.05), and there was a significant difference in lactate stimulation scores before and after sample use.

[0340] Table 3-1 Descriptive statistics of lactic acid stimulation scores before and after sample use

[0341]

[0342] Note: The Shapiro-Wilk test has a significance value > 0.05 for normality testing, and the difference before and after the test follows a normal distribution.

[0343] Table 3-2 Analysis of differences in skin spots before and after sample use

[0344]

[0345] Notes: 1. Rate of change = [(after sample use - before sample use) / before sample use] × 100%. 2. Significant difference: P < 0.05; No significant difference: P ≥ 0.05. 3. * indicates that the two groups of data were compared using a paired t-test; ** indicates that the two groups of data were compared using a rank-sum test.

[0346] 5. Experimental Conclusions

[0347] Based on a combination of subjective ratings and objective instrument testing results, the soothing skincare ball described in this invention has the following efficacy characteristics:

[0348] Soothing and Repairing: Continuous use of the test sample for 7 days can significantly reduce transepidermal moisture loss and repair the skin barrier.

[0349] Redness reduction effect: Continuous use of the test sample for 7 days can significantly reduce the skin erythema index and improve facial redness.

[0350] Therefore, it can be seen that the skin care ball of the present invention has a significant soothing and repairing effect on sensitive skin.

[0351] The embodiments described above are merely preferred embodiments of the present invention and are not intended to limit the scope of the present invention. Various modifications and improvements made by those skilled in the art to the technical solutions of the present invention without departing from the spirit of the present invention should fall within the protection scope defined by the claims of the present invention.

Claims

1. A combination of fast-dissolving formulations, characterized in that: It includes at least one layer of a low-moisture, fast-dissolving, porous body and at least one layer of a low-moisture, oil-containing, fast-dissolving binder.

2. The combined instant dissolving formulation according to claim 1, characterized in that: The weight ratio of the loose porous body to the adhesive is 1:10 to 10:

1.

3. The combined instant dissolving formulation according to claim 2, characterized in that: The weight ratio of the loose porous body to the adhesive is 1:5 to 5:

1.

4. The combined instant dissolving formulation according to claim 3, characterized in that: The weight ratio of the loose porous body to the adhesive is 1:3 to 3:

1.

5. The combined instant-dissolving formulation according to claim 1, characterized in that: The loose porous body comprises a binder and a skeleton support agent in a weight ratio of 1:10 to 10:

1.

6. The combined instant dissolving formulation according to claim 5, characterized in that: The weight ratio of the adhesive to the skeleton support is 1:5 to 5:

1.

7. The combined instant dissolving formulation according to claim 6, characterized in that: The weight ratio of the adhesive to the skeleton support is 1:3 to 3:

1.

8. The combined instant-dissolving formulation according to any one of claims 5-7, characterized in that: The binder is selected from one or more of the following: gums, microbial fermentation gums, cellulose derivatives, seaweed extract gums, animal-derived gums, synthetic and semi-synthetic polymers, modified starches, starch, modified cellulose, cellulose ethers, hyaluronic acid, carbomer, sodium alginate, polyvinyl alcohol, polyethylene glycol, polyamino acids, povidone, and sodium polyacrylate; the amount of the binder is 3% to 95% of the total amount of loose porous material.

9. The combined instant dissolving formulation according to claim 8, characterized in that: The amount of the binder is 3% to 60% of the total amount of loose porous material.

10. The combined instant-dissolving formulation according to claim 9, characterized in that: The amount of the binder is 3% to 20% of the total amount of loose porous material.

11. The combined instant dissolving formulation according to any one of claims 5-7, characterized in that: The skeleton support is selected from sugars, sugar alcohols, dextrins, amino acids, inorganic substances, minerals, proteins, starches, self-emulsifying composite waxes and modified cellulose, preferably one or more of mannitol, maltodextrin, glycine, trehalose, corn starch, starch, β-cyclodextrin, sugar, and kaolin. The amount of the skeleton support is 5% to 95% of the total amount of loose porous material.

12. The combined instant-dissolving formulation according to claim 11, characterized in that: The amount of the skeleton support agent is 10%-80% of the total amount of loose porous material.

13. The combined instant dissolving formulation according to claim 12, characterized in that: The amount of the skeleton support agent is 30%-60% of the total amount of loose porous material.

14. The combined instant-dissolving formulation according to any one of claims 5-7, characterized in that: The loose porous body also contains functional ingredients; the functional ingredients are selected from one or more of chemical drug ingredients, traditional Chinese medicine ingredients, natural extracts, bioactive ingredients, disinfectants, and nutritional supplements; the amount of the functional ingredients is 1% to 95% of the total amount of loose porous body material.

15. The combined instant-dissolving formulation according to claim 14, characterized in that: The amount of the active ingredient is 1% to 50% of the total amount of loose porous material.

16. The combined instant dissolving formulation according to claim 15, characterized in that: The amount of the active ingredient is 1% to 30% of the total amount of loose porous material.

17. The combined instant-dissolving formulation according to any one of claims 5-7, characterized in that: The porous body further comprises a surfactant; the surfactant is selected from one or more of anionic surfactants, cationic surfactants, amphoteric surfactants, nonionic surfactants, and amino acid surfactants; Its dosage is 1% to 95% of the total amount of loose porous material.

18. The combined instant dissolving formulation according to claim 17, characterized in that: The amount of surfactant used is 1% to 50% of the total amount of loose porous material.

19. The combined instant dissolving formulation according to claim 18, characterized in that: The amount of surfactant used is 1% to 30% of the total amount of loose porous material.

20. The combined instant dissolving formulation according to claim 1, characterized in that: The adhesive is grease, whipped grease, or a mixture of grease and a skeletal support agent; When using grease and scaffold support, the weight ratio of the two is 1:10 to 10:

1.

21. The combined instant dissolving formulation according to claim 20, characterized in that: The weight ratio of the grease to the scaffold support is 1:5 to 5:

1.

22. The combined instant dissolving formulation according to claim 21, characterized in that: The weight ratio of the grease to the scaffold support is 1:3 to 3:

1.

23. The combined instant-dissolving formulation according to any one of claims 20-22, characterized in that: The oil is selected from one or more of animal fats, vegetable oils, synthetic / semi-synthetic oils, camellia oil, *Sapindus mukorossi* oil, palm oil, coconut oil, butter, anhydrous shortening, shea butter, cocoa butter, olive emulsified wax, lanolin, beeswax, shortening, hydrogenated vegetable oil, hydrogenated lecithin, petrolatum, squalane, and cetearyl alcohol. The amount of the oil used is 10% to 100% of the total amount of the binder material.

24. The combined instant dissolving formulation according to claim 23, characterized in that: The amount of grease used is 20% to 80% of the total amount of adhesive material.

25. The combined instant dissolving formulation according to claim 24, characterized in that: The amount of grease used is 30% to 70% of the total amount of binder material.

26. The combined instant dissolving formulation according to claim 23, characterized in that: The oil also contains a surfactant, which is selected from one or more of anionic surfactants, cationic surfactants, amphoteric surfactants, nonionic surfactants, amino acid surfactants, and phospholipid surfactants; the weight ratio of the surfactant to the oil is 1:10 to 10:

1.

27. The combined instant dissolving formulation according to claim 26, characterized in that: The weight ratio of the surfactant to the oil is 1:5 to 5:

1.

28. The combined instant dissolving formulation according to claim 27, characterized in that: The weight ratio of the surfactant to the oil is 1:3 to 3:

1.

29. The combined instant-dissolving formulation according to any one of claims 20-22, characterized in that: The skeleton support agent is selected from sugars, sugar alcohols, dextrins, amino acids, inorganic substances, minerals, proteins, starches, self-emulsifying composite waxes and modified cellulose, preferably one or more of mannitol, maltodextrin, glycine, trehalose, corn starch, starch, β-cyclodextrin, sugar, and kaolin. The amount of the skeleton support agent is 5% to 95% of the total amount of binder material.

30. The combined instant dissolving formulation according to claim 29, characterized in that: The amount of the skeleton support agent is 5%-55% of the total material of the adhesive.

31. The combined instant dissolving formulation according to claim 30, characterized in that: The amount of the skeleton support agent is 5%-35% of the total amount of adhesive material.

32. The combined instant-dissolving formulation according to any one of claims 20-22, characterized in that: The adhesive also contains functional ingredients; the functional ingredients are selected from one or more of chemical drug ingredients, traditional Chinese medicine ingredients, natural extracts, bioactive ingredients, disinfectants, and nutritional supplements; the amount of the functional ingredients is 1% to 95% of the total amount of adhesive material.

33. The combined instant dissolving formulation according to claim 32, characterized in that: The amount of the active ingredient is 1% to 50% of the total amount of the binder material.

34. The combined instant dissolving formulation according to claim 33, characterized in that: The amount of the active ingredient is 1% to 30% of the total amount of the binder material.

35. The combined instant dissolving formulation according to claim 1, characterized in that: The low water content in the loose porous body and the binder refers to a moisture content of ≤10%.

36. The combined instant dissolving formulation according to claim 35, characterized in that: The low water content in the loose porous body and the binder refers to a moisture content of ≤7%.

37. The combined instant dissolving formulation according to claim 36, characterized in that: The low water content in the loose porous body and the binder refers to a moisture content of ≤5%.

38. A method for preparing the combined instant-dissolving formulation according to any one of claims 1-37, characterized in that: The porous material is obtained by drying, including baking, microwave drying, infrared drying, airflow drying, low-temperature vacuum drying, and freeze drying.

39. The method for preparing the combined instant-dissolving formulation according to claim 38, characterized in that: The adhesive is prepared using a whipping or emulsification process.

40. The use of the combined instant-dissolving formulation according to any one of claims 1-37 in the preparation of oral or topical formulations for daily chemical personal care products or functional foods.

Images