Seamless soft capsule as well as preparation method and application thereof

Abstract

The invention provides a film-forming composition, a seamless soft capsule shell prepared from the film-forming composition, and a seamless soft capsule containing the soft capsule shell. The film-forming composition comprises: 1%-4% of a first gelling agent; 0.5%-10% of high ester pectin; 0.75 to 15% of a plasticizer; and at least 80% water wherein the first gelling agent is a low acyl gellan gum. The film-forming composition is low in solution viscosity and high in gel strength at room temperature, the seamless soft capsule prepared by dripping the film-forming composition as a film-forming material is high in strength and uniform in appearance, and the dried soft capsule product can be quickly disintegrated in a water medium.

Description

Technical Field

[0001] The invention relates to the field of soft capsules, in particular to seamless soft capsules and a preparation method and application thereof. Background Art

[0002] Seamless soft capsules are formed by the "dripping method", where the rubber material and contents flow out simultaneously from multiple nozzles in a concentric circle, and under different flow rates of each liquid and the conduction of a specific frequency, a spherical capsule with a stable filling and no gaps is finally formed. At present, the seamless capsule rubber technology is concentrated on gelatin. Gelatin, as the basic material of the seamless capsule shell membrane, has the following advantages: excellent solubility, high mechanical strength of the membrane and controllable viscosity, and the gel is reversible with temperature changes. However, the disadvantages are also obvious: cross-linking reactions are prone to occur, cold chain transportation is required, and gelatin from pigs, cattle, etc. is used, which may also be rejected by vegetarians and vegans.

[0003] CA3211920A1 discloses a seamless capsule shell composition, which comprises low acyl gellan gum, oxidized starch, calcium chloride, plasticizer and water, wherein the low acyl gellan gum solution reacts with calcium ions to generate a thermally irreversible gel structure, causing the shell solution to gel in advance during coextrusion. And at the moment when the seamless soft capsule is dripped on the shaping coolant, the capsule shell of the seamless soft capsule is instantly solidified and shaped due to the rapid action of calcium ions. Although the capsule shell strength is large, its shape is uneven and a uniform spherical structure cannot be prepared. In addition, the seamless soft capsule enhanced by curing is difficult to pass the disintegration test of the aqueous medium.

[0004] Existing technologies are all based on low acyl gellan gum combined with divalent metal ions for molding, and the use of a second gelling agent to assist in improving the gel properties of the gel solution. These result in high oil leakage rate and severe eccentricity during product molding, or failure to meet the disintegration test of the product in the later stage. Therefore, it is particularly urgent to research and develop a plant-based seamless soft capsule with uniform molding appearance, low oil leakage rate, and qualified disintegration test. Summary of the invention

[0005] The inventors have found through experiments that, in a film-forming composition with a high water content, low acyl gellan gum, pectin, water and a plasticizer are used as a film-forming composition to prepare soft capsules. Without adding alkali metal ions, the composition exhibits excellent low viscosity and high instantaneous gel strength at the moment of dripping, and there is no cracking or oil leakage during the drying process after shaping. Moreover, the dried soft capsules can quickly disintegrate in an aqueous medium disintegration test.

[0006] In one aspect, the present invention provides a film-forming composition comprising, by weight:

[0007] 1%-4% first gelling agent;

[0008] 0.5%-10% high ester pectin;

[0009] 0.75-15% plasticizer; and

[0010] At least 80% water,

[0011] Wherein, the first gelling agent is low acyl gellan gum.

[0012] In some embodiments, the content of divalent metal ions in the film-forming composition is insufficient to gel with the low acyl gellan gum. In some preferred embodiments, the content of divalent metal ions in the film-forming composition is 0.015% or less.

[0013] In some embodiments, the film-forming composition does not have additional added divalent metal ions, such as salts that provide divalent metal ions, such as Ca, Mn, Mg salts.

[0014] In some embodiments, the high ester pectin has a weight average molecular weight of 20,000 to 200,000 Da.

[0015] In some embodiments, the content of high ester pectin is 0.5%-0.83%, 0.83%-1%, 0.5%-1%, 1%-10% or 0.83%-10%. In a preferred embodiment, the content of high ester pectin is 0.83%.

[0016] In some embodiments, the low acyl gellan gum has less than 25% acetyl groups and less than 15% glyceryl groups per repeating unit.

[0017] In some embodiments, the content of the first gelling agent is 1%-2.5%, 2.5%-4%, or 2%-3%. In a preferred embodiment, the content of the first gelling agent is 2.5%.

[0018] In some embodiments, the plasticizer is selected from glycerol, sorbitol, xylitol, erythritol, maltitol and lactitol, and in a preferred embodiment, the plasticizer is glycerol. In some embodiments, the content of the plasticizer is 0.75-2%, 2%-15%, 0.75%-5% or 1%-3%. In a preferred embodiment, the content of the plasticizer is 2%.

[0019] In some embodiments, the film-forming composition further comprises an additive selected from at least one of a sweetener, a pigment, an opacifier and a flavor.

[0020] In a preferred embodiment, the sweetener content is below 2%, more preferably 1%.

[0021] In a preferred embodiment, the pigment content is below 2%, more preferably 0.15%.

[0022] In a preferred embodiment, the fragrance content is below 1%, more preferably 0.1%.

[0023] In a preferred embodiment, the sunscreen content is below 0.5%, more preferably 0.5%.

[0024] In some embodiments, the sweetener is selected from sucralose, neotame, aspartame, alitame, saccharin sodium, acesulfame potassium, psicose, advantame, cyclamate, thaumatin, steviol glycosides, mogroside, isomaltulose, ammonium glycyrrhizinate, monopotassium and tripotassium glycyrrhizinate, and D-mannitol.

[0025] In some embodiments, the sunscreen is selected from titanium dioxide, zinc oxide, and calcium carbonate.

[0026] In some embodiments, the pigment is selected from allura red, brilliant blue, lemon yellow, sunset yellow, cochineal, turmeric, annatto, gardenia yellow, gardenia blue, amaranth, safflower yellow, vegetable carbon black, carotene, and sodium copper chlorophyllin.

[0027] In some embodiments, the flavor is selected from peach flavor, strawberry flavor, cherry flavor, cantaloupe flavor, apple flavor, grape flavor, banana flavor, lemon flavor, jasmine flavor, blueberry flavor, fruity flavor, grapefruit flavor, olive flavor, and sweet orange flavor.

[0028] In some embodiments, the film-forming composition further comprises a second gelling agent selected from the group consisting of carrageenan, high acyl gellan gum, partially deacylated gellan gum, sodium alginate and agar.

[0029] In some embodiments, the content of the second gelling agent is 0.1%-0.5%, 0.1%-0.25%, 0.2%-0.3% or 0.25%-0.5%. In a preferred embodiment, the content of the second gelling agent is 0.25%.

[0030] In another aspect, the present invention provides a seamless soft capsule shell comprising the film-forming composition disclosed herein. In some embodiments, the water content in the film-forming composition is dried to 6-20 wt%.

[0031] In another aspect, the present invention provides a seamless soft capsule shell comprising the film-forming composition disclosed herein, wherein the water content in the film-forming composition is dried to 6-20 wt %.

[0032] In another aspect, the present invention provides a seamless soft capsule comprising the seamless soft capsule shell disclosed herein and contents.

[0033] In some embodiments, the contents are selected from the group consisting of oils, suspensions, and emulsions.

[0034] In some embodiments, the contents include one or more of chemical drugs, traditional Chinese medicine powder or extracts, plant extracts, plant oils or animal fats, vitamins, minerals, and carotenoids.

[0035] In some embodiments, the vegetable oil or animal fat is selected from MCT oil, DHA algae oil, fish oil, flaxseed oil, rice bran oil, evening primrose oil, borage oil, wheat germ oil, conjugated linoleic acid, Ganoderma lucidum spore oil, pear oil, krill oil, garlic oil, almond oil, perilla seed oil, olive oil, squalene, sesame oil, pumpkin seed oil, safflower seed oil, shea butter, camellia oil, saw palmetto extract oil, walnut oil, castor oil, grape seed oil, cottonseed oil, peanut oil, soybean oil, corn oil, sunflower seed oil, rapeseed oil and palm oil.

[0036] In some embodiments, the vitamin is selected from fat-soluble vitamins. In some embodiments, the vitamin is selected from vitamin A, vitamin D, vitamin E and vitamin K.

[0037] In some embodiments, the carotenoid is selected from lutein, lutein esters, beta-carotene, lycopene, and zeaxanthin.

[0038] In some embodiments, a seamless soft capsule is prepared by the following method: the method comprises preparing using the composition disclosed herein.

[0039] In some preferred embodiments, the method comprises sol, dripping and drying steps, wherein

[0040] (1) Sol: A) mixing the first gelling agent, high ester pectin, plasticizer and water, and stirring until the mixture is uniform; B) heating and stirring the mixture of step A) at 60-98° C. until the colloid is completely dissolved; C) removing bubbles,

[0041] (2) dripping: the gelatin solution is transported to the dripper of the seamless soft capsule production equipment, the contents are added to the dripper, and the seamless soft capsules are produced by dripping, and the pellets are formed by rotating the cage, and

[0042] (3) Drying: Drying the capsules until the moisture content of the capsule shell is 6-20%.

[0043] In other embodiments, the seamless soft capsule is prepared by the following method:

[0044] (1) Sol: A) using part of water and / or plasticizer to completely disperse the additives at room temperature, then adding to the remaining water and stirring, then adding the first gelling agent and high ester pectin and stirring until the mixture is uniform; B) heating and stirring at 60-98° C. until the colloid is completely dissolved; C) removing bubbles,

[0045] (2) dripping: the gelatin solution is transported to the dripper of the seamless soft capsule production equipment, the contents are added to the dripper, and the seamless soft capsules are produced by dripping, and the pellets are formed by rotating the cage, and

[0046] (3) Drying: Drying the capsules until the moisture content of the capsule shell is 6-20%.

[0047] In another aspect, the present invention provides a method for preparing a seamless soft capsule, which comprises preparing the capsule using the composition disclosed herein.

[0048] In some preferred embodiments, the method comprises sol, dripping and drying steps, wherein

[0049] (1) Sol: A) mixing the first gelling agent, high ester pectin, plasticizer and water, and stirring until the mixture is uniform; B) heating and stirring the mixture of step A) at 60-98° C. until the colloid is completely dissolved; C) removing bubbles,

[0050] (2) dripping: the gelatin solution is transported to the dripper of the seamless soft capsule production equipment, the contents are added to the dripper, and the seamless soft capsules are produced by dripping, and the pellets are formed by rotating the cage, and

[0051] (3) Drying: Drying the capsules until the moisture content of the capsule shell is 6-20%.

[0052] In other preferred embodiments, the method comprises sol, dripping and drying steps, wherein

[0053] (1) Sol: A) using part of water and / or plasticizer to completely disperse the sweetener, pigment, flavor and opacifier at room temperature, and then adding them to the remaining water and stirring, and then adding the first gelling agent and high ester pectin and stirring until the mixture is uniform; B) heating and stirring at 60-98° C. until the colloid is completely dissolved; C) removing bubbles,

[0054] (2) dripping: the gelatin solution is transported to the dripper of the seamless soft capsule production equipment, the contents are added to the dripper, and the seamless soft capsules are produced by dripping, and the pellets are formed by rotating the cage, and

[0055] (3) Drying: Drying the capsules until the capsule shell moisture content is 6-20%.

[0056] In another aspect, the present invention provides the use of the film-forming composition disclosed herein or the seamless soft capsule disclosed herein in food, medicine and / or cosmetics. In a preferred embodiment, the food is a health food. DETAILED DESCRIPTION

[0057] During the experiment, the inventor found that when only low-acyl gellan gum, plasticizer and a high content of water (more than 80%) were used as film-forming compositions to prepare soft capsules, the film was very brittle and almost impossible to gel. The shell of the seamless soft capsule could not quickly gel and formed, resulting in direct collapse and shattering in the coolant. When low-acyl gellan gum, additional divalent metal ions, plasticizer and a high content of water (more than 80%) were used as film-forming compositions to prepare soft capsules, whether the divalent metal ions were added before the sol or added after the seamless soft capsules were formed and solidified, the product appearance was uneven or the product disintegration test failed.

[0058] High ester pectin can gel in low pH and high sugar environment, so in the high ester pectin solution system with high water content (more than 80%), the high ester pectin solution does not gel at room temperature. Low acyl gellan gum itself hardly gels, and can only form gel after adding monovalent and divalent metal ions. When low acyl gellan gum and high ester pectin are compounded, according to known inferences, the compounded solution should maintain a non-gel state. However, the inventors were surprised to find that the compounded colloid not only gels, but also has a greatly increased gel strength compared to existing products. A strong gel strength is formed in the instant of dripping seamless soft capsules, which meets the molding requirements. There is no cracking and oil leakage of soft capsules during the drying process, and the product shows the ability of rapid disintegration in aqueous media. The inventors have found through experiments that soft capsules can be prepared by using low-acyl gellan gum, high-ester pectin, water and plasticizer as film-forming compositions. Without the addition of alkali metal ions, the glue liquid exhibits excellent low viscosity and high gel strength. At the same time, the glue liquid has a certain toughness after gelling, which not only ensures that the glue liquid has sufficient flowability during the molding process, but also the seamless soft capsules after drop molding have high gel strength and excellent impact resistance during the drying process. The surface of the formed film is smooth, the drop-molded soft capsules do not leak oil, the product disintegration test is qualified, and it is suitable for large-scale production.

[0059] During the molding process of seamless soft capsules, the compounded glue solution is wrapped by the dripper in a high-temperature molten state and then cooled and shaped into a spherical sphere in the coolant. When the glass transition temperature of the film-forming composition solution is higher than room temperature, the solution can solidify quickly in the coolant and quickly enter the glass state, showing high film-forming strength. The addition of high-ester pectin also improves the gel strength of gellan gum. The gel strength of the seamless soft capsule glue solution after complete gel curing is >1000g / cm2, so that the capsule shell of the seamless soft capsule has sufficient strength. Ensure that the composition capsule shell has high gel strength to meet the needs of the capsules in the subsequent drying process. Sufficient strength, thereby resisting rolling and capsule stacking during the drying process. If the solidification temperature of the film-forming composition solution is particularly high, during the molding process, the film-forming composition solution needs to be in a high temperature state to ensure the low viscosity required for molding, and the solution is stored at high temperature for a long time, causing the film-forming composition colloid to degrade and the molding difficulty to increase. In the present application, due to the addition of pectin and low acyl gellan gum, the viscosity of these two colloids is low, resulting in a seamless soft capsule solution viscosity of <1000cp under 80°C insulation conditions, without the need for excessively high temperatures. All of these contribute to the formation of a spherical sphere with uniform appearance after dripping of the seamless soft capsule, and the capsule shell has a sufficiently strong strength, so that the soft capsule does not leak oil after final drying. In addition, the addition of high ester pectin also avoids the additional addition of divalent metal ions, and avoids the inability of gellan gum to disintegrate in an aqueous medium after gelling.

[0060] the term

[0061] As used herein, the term "comprising" is synonymous with "including", "containing", and is inclusive or open-ended, and does not exclude additional unrecited elements or method steps. "Comprising" is a technical term used in the claim language, meaning that the elements are present, but other elements may also be added and still form a structure or method within the scope of the claim.

[0062] The term "and / or" is used to describe the association relationship of associated objects, indicating that there can be three types of relationships. For example, A and / or B can mean: A exists alone, B exists alone, and A and B exist at the same time. A and B can be singular or plural. The character " / " generally indicates that the associated objects are in an "or" relationship.

[0063] The term "at least one" means one or more, and "plurality" means two or more. "At least one of the following" or similar expressions refers to any combination of these items, including any combination of single items or plural items. For example, "at least one of a, b or c", or "at least one of a, b and c" can all mean: a, b, c, ab (i.e. a and b), ac, bc, or abc, where a, b, c can be single or plural, respectively.

[0064] Unless otherwise indicated, "%" used herein means percent by weight.

[0065] The term "high ester pectin" herein refers to pectin having a degree of esterification (e.g., degree of methyl esterification) of not less than 50%, such as 50-80%. In this article, the degree of esterification refers to the degree of substitution of esterification. In one or more embodiments, the degree of esterification of high ester pectin described herein is not less than 50%, such as not less than 60%, not less than 70%, such as not less than 80%, such as not less than 85%, such as not less than 90%. In one or more embodiments, the degree of esterification of high ester pectin described herein is not more than 90%, not more than 89%, not more than 88%, not more than 87%, not more than 86%, not more than 85%, not more than 84%, not more than 83%, not more than 82%, not more than 81%, not more than 80%, not more than 79%, not more than 78%, not more than 77%, not more than 76%, not more than 75%, not more than 74%. For example, the degree of esterification of the high ester pectin described herein is 50-85%. In a preferred embodiment, the degree of esterification of the high ester pectin herein is 50-70%, for example 60%, 51-61%, 52-62%, 53-63%, 54-64%, 55-65%, 56-66%, 57-67%, 58-68%, 59-69%.

[0066] High ester pectin can only form gels at soluble solids content above 65% and pH between 2.0-3.8. Gel formation occurs at the interface of cross-linked polymers, where hydrogen bonds and repulsion between methyl groups allow sugars and water to enter the pectin network.

[0067] The meanings of the terms "low acyl gellan gum", "high acyl gellan gum" and "partially deacylated gellan gum" are well known in the art and are generally understood in the art herein. For example, "low acyl gellan gum" may refer to gellan gum having less than 25% acetyl groups and less than 15% glycerol residues as substituents per repeating unit; "high acyl gellan gum" may refer to gellan gum having more than 40% acetyl groups and more than 45% glycerol residues as substituents per repeating unit; "partially deacylated gellan gum" refers to gellan gum containing 25% to 40% acetyl residues per repeating unit.

[0068] The term "divalent metal ion" has the meaning known in the art and refers to a metal atom having two valence electrons, such as Ca2+, Mn2+, Mg2+, etc.

[0069] The term "Dalton" refers to the unit of molecular weight, represented herein by the symbol Da.

[0070] Film-forming composition

[0071] The present invention provides a film-forming composition, which comprises by weight: 1%-4% of a first gelling agent; 0.5%-10% of high ester pectin; 0.75-15% of a plasticizer; and at least 80% of water, wherein the first gelling agent is low acyl gellan gum.

[0072] In some embodiments, the first gelling agent is present in an amount of 1%, 2%, 3%, or 4%. In other embodiments, the high ester pectin is present in an amount of 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, or 15%. In other embodiments, the plasticizer is present in an amount of 0.75%, 0.8%, 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, or 15%. In other embodiments, the water content is at least 80%, at least 81%, at least 82%, at least 83%, at least 84%, at least 85%, at least 86%, at least 87%, at least 88%, at least 89%, at least 90%, at least 91%, at least 92%, at least 93%, at least 94%, at least 95%, at least 96% or at least 97%. In some embodiments, the content of divalent metal ions in the film-forming composition is insufficient to gel with the low acyl gellan gum. In some preferred embodiments, the content of divalent metal ions in the film-forming composition is 0.015% or less.

[0073] In some embodiments, the weight average molecular weight of high ester pectin is 20,000 to 200,000 Da, for example, 20,000, 30,000, 40,000, 50,000, 60,000, 70,000, 80,000, 90,000, 100,000, 110,000, 120,000, 130,000, 140,000, 150,000, 160,000, 170,000, 180,000, 190,000 or 200,000 Da.

[0074] In some embodiments, the content of high ester pectin is 0.5%-0.83%, 0.83%-1%, 0.5%-1%, 1%-10% or 0.83%-10%. For example, 0.5%, 0.83%, 1%, or 10%. In a preferred embodiment, the content of high ester pectin is 0.83%.

[0075] In some embodiments, the low acyl gellan gum has less than 25% acetyl groups and less than 15% glyceryl groups per repeating unit. In some embodiments, the low acyl gellan gum has less than 25% acetyl groups and less than 15% glyceryl groups per repeating unit.

[0076] In some embodiments, the content of the first gelling agent is 1%-2.5%, 2.5%-4%, or 2%-3%. In a preferred embodiment, the content of the first gelling agent is 2.5%.

[0077] In some embodiments, the plasticizer is selected from glycerol, sorbitol, xylitol, erythritol, maltitol and lactitol. In a preferred embodiment, the plasticizer is glycerol. In some embodiments, the content of the plasticizer is 0.75-2%, 2%-15%, 0.75%-5% or 1%-3%. In a preferred embodiment, the content of the plasticizer is 2%.

[0078] In some embodiments, the film-forming composition further comprises an additive selected from at least one of a sweetener, a pigment, an opacifier and a flavor.

[0079] In a preferred embodiment, the sweetener content is below 2%, more preferably 1%.

[0080] In a preferred embodiment, the pigment content is below 2%, more preferably 0.15%.

[0081] In a preferred embodiment, the fragrance content is below 1%, more preferably 0.1%.

[0082] In a preferred embodiment, the sunscreen content is below 0.5%, more preferably 0.5%.

[0083] In some embodiments, the sweetener is selected from sucralose, neotame, aspartame, alitame, saccharin sodium, acesulfame potassium, psicose, advantame, cyclamate, thaumatin, steviol glycosides, mogroside, isomaltulose, ammonium glycyrrhizinate, monopotassium and tripotassium glycyrrhizinate, and D-mannitol.

[0084] In some embodiments, the sunscreen is selected from titanium dioxide, zinc oxide, and calcium carbonate.

[0085] In some embodiments, the pigment is selected from allura red, brilliant blue, lemon yellow, sunset yellow, cochineal, turmeric, annatto, gardenia yellow, gardenia blue, amaranth, safflower yellow, vegetable carbon black, carotene, and sodium copper chlorophyllin.

[0086] In some embodiments, the flavor is selected from peach flavor, strawberry flavor, cherry flavor, cantaloupe flavor, apple flavor, grape flavor, banana flavor, lemon flavor, jasmine flavor, blueberry flavor, fruity flavor, grapefruit flavor, olive flavor, and sweet orange flavor.

[0087] In some embodiments, the film-forming composition further comprises a second gelling agent selected from the group consisting of carrageenan, high acyl gellan gum, partially deacylated gellan gum, sodium alginate and agar.

[0088] In some embodiments, the content of the second gelling agent is 0.1%-0.5%, 0.1%-0.25%, 0.2%-0.3% or 0.25%-0.5%. In a preferred embodiment, the content of the second gelling agent is 0.25%.

[0089] Seamless soft capsule shell

[0090] In some embodiments, the present invention provides a seamless soft capsule shell comprising a film-forming composition disclosed herein. In some embodiments, the water content in the film-forming composition is dried to 6-20wt%, for example, the water content is 6wt%, 7wt%, 8wt%, 9wt%, 10wt%, 11wt%, 12wt%, 13wt%, 14wt%, 15wt%, 16wt%, 17wt%, 18wt%, 19wt% or 20wt%.

[0091] In some embodiments, the present invention provides a seamless soft capsule shell, which comprises a film-forming composition disclosed herein, wherein the water content in the film-forming composition is dried to 6-20wt%, for example, the water content is 6wt%, 7wt%, 8wt%, 9wt%, 10wt%, 11wt%, 12wt%, 13wt%, 14wt%, 15wt%, 16wt%, 17wt%, 18wt%, 19wt% or 20wt%.

[0092] In some embodiments, the present invention provides a seamless soft capsule shell prepared from the film-forming composition disclosed herein, which comprises the film-forming composition disclosed herein, and wherein the water content in the film-forming composition is dried to 6-20wt%, for example, the water content is 6wt%, 7wt%, 8wt%, 9wt%, 10wt%, 11wt%, 12wt%, 13wt%, 14wt%, 15wt%, 16wt%, 17wt%, 18wt%, 19wt% or 20wt%.

[0093] Seamless soft capsule

[0094] The present invention provides a seamless soft capsule, which comprises the seamless soft capsule shell disclosed herein and contents.

[0095] In some embodiments, the contents are selected from the group consisting of oils, suspensions, and emulsions.

[0096] In some embodiments, the contents include one or more of chemical drugs, traditional Chinese medicine powder or extracts, plant extracts, plant oils or animal fats, vitamins, minerals, and carotenoids.

[0097] In some embodiments, the vegetable oil or animal fat is selected from MCT oil, DHA algae oil, fish oil, flaxseed oil, rice bran oil, evening primrose oil, borage oil, wheat germ oil, conjugated linoleic acid, Ganoderma lucidum spore oil, pear oil, krill oil, garlic oil, almond oil, perilla seed oil, olive oil, squalene, sesame oil, pumpkin seed oil, safflower seed oil, shea butter, camellia oil, saw palmetto extract oil, walnut oil, castor oil, grape seed oil, cottonseed oil, peanut oil, soybean oil, corn oil, sunflower seed oil, rapeseed oil and palm oil.

[0098] In some embodiments, the vitamin is selected from fat-soluble vitamins. In some embodiments, the vitamin is selected from vitamin A, vitamin D, vitamin E and vitamin K.

[0099] In some embodiments, the carotenoid is selected from lutein, lutein esters, beta-carotene, lycopene, and zeaxanthin.

[0100] In some embodiments, a seamless soft capsule is prepared by the following method: the method comprises preparing using the composition disclosed herein.

[0101] In some preferred embodiments, the method comprises sol, dripping and drying steps, wherein

[0102] (1) Sol: A) mixing the first gelling agent, high ester pectin, plasticizer and water, and stirring until the mixture is uniform; B) heating and stirring the mixture of step A) at 60-98° C. until the colloid is completely dissolved; C) removing bubbles,

[0103] (2) dripping: the gelatin solution is transported to the dripper of the seamless soft capsule production equipment, the contents are added to the dripper, and the seamless soft capsules are produced by dripping, and the pellets are formed by rotating the cage, and

[0104] (3) Drying: Drying the capsule until the water content of the capsule shell is 6-20%, for example, the water content is 6wt%, 7wt%, 8wt%, 9wt%, 10wt%, 11wt%, 12wt%, 13wt%, 14wt%, 15wt%, 16wt%, 17wt%, 18wt%, 19wt% or 20wt%.

[0105] In other embodiments, the seamless soft capsule is prepared by the following method:

[0106] (1) Sol: A) using part of water and / or plasticizer to completely disperse the additives at room temperature, then adding to the remaining water and stirring, then adding the first gelling agent and high ester pectin and stirring until the mixture is uniform; B) heating and stirring at 60-98° C. until the colloid is completely dissolved; C) removing bubbles,

[0107] (2) dripping: the gelatin solution is transported to the dripper of the seamless soft capsule production equipment, the contents are added to the dripper, and the seamless soft capsules are produced by dripping, and the pellets are formed by rotating the cage, and

[0108] (3) Drying: Drying the capsule until the water content of the capsule shell is 6-20%, for example, the water content is 6wt%, 7wt%, 8wt%, 9wt%, 10wt%, 11wt%, 12wt%, 13wt%, 14wt%, 15wt%, 16wt%, 17wt%, 18wt%, 19wt% or 20wt%.

[0109] Preparation method

[0110] The present invention provides a method for preparing seamless soft capsules, which comprises using the composition disclosed herein for preparation.

[0111] In some preferred embodiments, the method comprises sol, dripping and drying steps, wherein

[0112] (1) Sol: A) mixing the first gelling agent, high ester pectin, plasticizer and water, and stirring until the mixture is uniform; B) heating and stirring the mixture of step A) at 60-98° C. until the colloid is completely dissolved; C) removing bubbles,

[0113] (2) dripping: the gelatin solution is transported to the dripper of the seamless soft capsule production equipment, the contents are added to the dripper, and the seamless soft capsules are produced by dripping, and the pellets are formed by rotating the cage, and

[0114] (3) Drying: Drying the capsule until the water content of the capsule shell is 6-20%, for example, the water content is 6wt%, 7wt%, 8wt%, 9wt%, 10wt%, 11wt%, 12wt%, 13wt%, 14wt%, 15wt%, 16wt%, 17wt%, 18wt%, 19wt% or 20wt%.

[0115] In other preferred embodiments, the method comprises sol, dripping and drying steps, wherein

[0116] (1) Sol: A) using part of water and / or plasticizer to completely disperse the sweetener, pigment, flavor and opacifier at room temperature, and then adding them to the remaining water and stirring, and then adding the first gelling agent and high ester pectin and stirring until the mixture is uniform; B) heating and stirring at 60-98° C. until the colloid is completely dissolved; C) removing bubbles,

[0117] (2) dripping: the gelatin solution is transported to the dripper of the seamless soft capsule production equipment, the contents are added to the dripper, and the seamless soft capsules are produced by dripping, and the pellets are formed by rotating the cage, and

[0118] (3) Drying: Drying the capsule until the water content of the capsule shell is 6-20%, for example, the water content is 6wt%, 7wt%, 8wt%, 9wt%, 10wt%, 11wt%, 12wt%, 13wt%, 14wt%, 15wt%, 16wt%, 17wt%, 18wt%, 19wt% or 20wt%.

[0119] Example

[0120] The embodiments of the present application will be described in detail below in conjunction with the examples. It will be appreciated by those skilled in the art that the following examples are only used to illustrate the present application and should not be considered as limiting the scope of the present application. If the specific conditions are not specified in the examples, they are carried out according to the conditions recommended by the normal conditions or manufacturers. If the reagents or instruments used do not specify the manufacturer, they are all conventional products that can be obtained commercially. If not specifically indicated, the amounts listed are all based on the gross weight and described in mass percentage. The present application should not be construed as being limited to the specific embodiments described.

[0121] 1. Materials

[0122] The materials used in the following examples are all commercially available.

[0123] Low acyl gellan gum (22% acetyl and 13% glycerol residue substitution)

[0124] High ester pectin (60% esterification)

[0125] 2. Soft Capsule Preparation

[0126] (1) Sol: A) Add gellan gum, pectin, plasticizer and water according to the specific amounts used in the following examples, and stir until the mixture is uniform; B) Heat and stir at 60-98°C until the colloid is completely dissolved; C) Remove the bubbles to obtain a sol solution. In the examples involving the use of additives such as sweeteners, pigments, sunscreens and flavors, the following steps are used to make a sol: A) Use part of the water / plasticizer to completely disperse the sweeteners, pigments, sunscreens and flavors at room temperature, add them to the remaining water and stir, then add gellan gum and pectin and stir until the mixture is uniform; B) Heat and stir at 60-98°C until the colloid is completely dissolved; C) Remove the bubbles to obtain a sol solution.

[0127] (2) Dripping production: A seamless soft capsule production line is used to transport the gelatin solution to the dripper of the seamless soft capsule production equipment. After the functional contents are added into the dripper, seamless soft capsules are produced by dripping and further shaped by cage rotation.

[0128] (3) Drying: Dry the formed or cage-shaped capsules until the moisture content of the capsule shell is 6-20%.

[0129] 3. Evaluation indicators

[0130] (1) Molding

[0131] 1) Pellet breakage rate (n): Use the quantitative statistical method to count the number of broken pills during the drop molding process (before drying) / the total number of produced pills*100%. The smaller the pellet breakage rate, the more suitable the gel temperature, the higher the strength of the rubber skin, and the more stable the molding.

[0132] 2) Appearance of soft capsules: observe whether the appearance of the soft capsules just after the drop-molding process (before drying) is uniform and whether the surface is smooth. If both meet the requirements, the score is 100. If the appearance is uneven or the surface of the capsule shell is not smooth, the appearance score is 0. The higher the score, the better the quality of the capsule.

[0133] (2) Disintegration performance in aqueous medium

[0134] According to the general rules of the four volumes of the Chinese Pharmacopoeia <0921> Disintegration test is conducted on soft capsules according to the provisions in the disintegration test. Disintegration refers to the complete disintegration, dissolution or fragmentation under the specified conditions. Except for insoluble coating materials or broken capsule shells, all should pass through the sieve. If a small amount (about less than 1 / 3) cannot pass through the sieve, but it has softened or lightly floated and has no hard core, it can be considered to meet the requirements, that is, the disintegration end point. Take the dried seamless soft capsule in a water medium (temperature is 37℃±1℃), use a disintegration instrument and a 6-hole hanging basket for testing (if it floats on the liquid surface, a baffle can be added). The soft capsule disintegrates within the specified time of 60 minutes.

[0135] (3) Comprehensive evaluation

[0136] The comprehensive score of seamless soft capsules was calculated according to Table 1. The molding pill breakage rate index, appearance evaluation index and disintegration evaluation index in water medium were used to score and comprehensively evaluate the production feasibility of seamless soft capsules. The total score of the comprehensive evaluation of the three indicators must be 6 points or above to meet the industrial production of seamless soft capsules. The higher the score, the better the overall performance. In the production process of seamless soft capsules, molding and disintegration evaluation in water medium both play an indispensable and key role, which directly affects the feasibility of commercial production. Therefore, the molding pill breakage rate and disintegration evaluation in water medium each account for 40%.

[0137] In summary, the comprehensive evaluation is obtained by combining the pill breakage rate (40%), the appearance evaluation (20%), and the disintegration evaluation in water medium (40%). The comprehensive evaluation must be above 6 points to realize the industrial production of seamless soft capsules.

[0138] Table 1

[0139]

[0140] (4) Evaluation of divalent metal ion content

[0141] The magnesium content is determined according to the second method of GB 5009.241-2017; the calcium content is determined according to the third method of GB 5009.92-2016. The content of divalent metal ions in the film-forming composition is the sum of the magnesium ion content and the calcium ion content.

[0142] Example 1-5, Comparative Example 1-4: Effect of component content in seamless soft capsules

[0143] According to the formula in Table 2, seamless soft capsules were prepared according to the above method and the performance was tested.

[0144] Table 2

[0145]

[0146]

[0147] Embodiment 1-5 adjusts the ratio of low acyl gellan gum and high ester pectin in the formula, even under high water content, the viscosity of the film-forming composition is less than 1000cp at 80°C, and the seamless soft capsule can maintain a uniform sphere when dripped into the coolant. And the glass transition temperature T of the solution is greater than 20°C, which allows the film-forming composition to be quickly cooled in the coolant to reach a glassy state, and improves its own gel strength to more than 1000g, which also ensures that the seamless soft capsule just dripped and formed maintains no deformation in appearance during the drying stage, good uniformity, no cracking and oil leakage, low molding broken pill rate, and increased yield. The seamless soft capsules prepared in Embodiment 1-5 have high roundness and good uniformity after drying, can quickly disintegrate in an aqueous medium, and the comprehensive evaluation indexes of the products are all higher than 6, which are suitable for large-scale production requirements.

[0148] In a system with high water content, the high ester pectin solution belongs to an acidic solution. When added to the low acyl gellan gum solution, the mixed solution is in an acidic system, and the H+ ions in the high ester pectin can promote the low acyl gellan gum to form a high-strength gel after cooling. When the high ester pectin is in a high water content system, the high ester pectin self gel is limited, so the high ester pectin molecular chain segments are interspersed in the gellan gum gel network. After the composition solution cools the gel and forms the capsule skin of the seamless soft capsule after drying, when the dried seamless soft capsule disintegrates in the aqueous medium, the high ester pectin acts as a disintegrant, and the seamless soft capsule rapidly expands after encountering water, and the high ester pectin chain segment is in a non-gel state, and the galacturonic acid radical in the chain segment robs the low acyl gellan gum molecular chain segment for connection H+ ions, so that the low acyl gellan gum is quickly degelated and dissolved in the aqueous medium. The finally dried soft capsule macroscopically manifests as rapid disintegration in the aqueous medium.

[0149] Compared with the formula of Examples 1-5, the proportion of low acyl gellan gum in Comparative Example 1 is too large. Although the gel strength of the film-forming composition increases, it is beneficial for the soft capsule not to break during drying, but the viscosity of the film-forming composition at 80°C exceeds 1000cp, so that the film-forming composition solution is dripped into the coolant, and the viscosity is too large to cause uneven appearance, increased molding breakage rate, and increased disintegration time in the aqueous medium. In Comparative Example 2, the proportion of low acyl gellan gum is too low, the gel strength of the film-forming composition decreases, the molding breakage rate increases, and the appearance is uneven. In Comparative Example 3, the proportion of pectin is too large. Although the disintegration time in the aqueous medium is shortened, the gel strength of the film-forming composition decreases, the viscosity increases, resulting in an increase in the molding breakage rate and an uneven appearance. In Comparative Example 4, the proportion of pectin is too low, the gel strength of the film-forming composition decreases, the molding breakage rate increases, and the disintegration time in the aqueous medium increases. And the comprehensive indicators of the products of Comparative Examples 1-4 are all less than 6, which does not meet the requirements of large-scale production of products.

[0150] Example 6-7, Comparative Example 5-6: Effect of high ester pectin weight average molecular weight

[0151] According to the formula in Table 3, seamless soft capsules were prepared according to the above method and the performance was tested.

[0152] Table 3

[0153]

[0154]

[0155] Examples 6 and 7 respectively use high ester pectin with a weight average molecular weight of 20000Da and 200000Da, and the comprehensive indexes of the products are all higher than 6, while Comparative Examples 5 and 6 use high ester pectin with a weight average molecular weight of 10000Da and 250000Da, the former has an increased disintegration time in aqueous medium, and the latter has a viscosity of more than 1000cp at 80°C, resulting in an increased pellet breakage rate. However, the comprehensive evaluation of both products is higher than 6, meeting the requirements of large-scale production.

[0156] Comparative Example 7-19

[0157] A seamless soft capsule formula in the prior art was selected for preparation as a control for the present application. According to the formulas in Table 4 and Table 5, seamless soft capsules were prepared according to the above method and performance tests were performed.

[0158] Table 4

[0159]

[0160] Note: “ / ” indicates that no dry sample was disintegrated in water medium

[0161] Comparative Example 7 only adds low acyl gellan gum, glycerol and water, because low acyl gellan gum gel needs the participation of monovalent and divalent metal ions to form at low temperatures, so the film-forming composition cannot gel at room temperature. Comparative Example 8 adds monovalent metal ions (sodium citrate dihydrate) on the basis of Comparative Example 7, although the film-forming composition can form gel at room temperature, its gel strength is less than 1000g, the molding broken pill rate is high, and the product appearance is uneven. Comparative Examples 9 and 10 add calcium chloride on the basis of Comparative Example 7, the former is to add calcium chloride to the film-forming composition before drip molding, so that the gel strength of the film-forming composition is increased, but what it generates is thermal irreversible gel, the difficulty increases during the dripping process, and the molding broken pill rate increases, and the latter is to add the seamless soft capsule after dripping into the calcium chloride curing agent to solidify, but the gel strength of the film-forming composition is low during its dripping, and the molding broken pill rate of the transfer curing process is extremely high. And both use divalent metal ions to enhance gel strength, which causes the dried product to be unable to disintegrate in an aqueous medium. Comparative Example 11 is based on Comparative Example 7, and citric acid is added. Although the gel strength of the film-forming composition is enhanced, the product cannot disintegrate in the water medium after drying. Comparative Example 12 is composed of high acyl gellan gum, high ester pectin, glycerin and water. The gel strength of its film-forming composition is low, the viscosity at 80°C is greater than 1000cp, and its glass transition temperature T is lower than 20°C, which makes it in a highly elastic state in the coolant at room temperature. The pill breakage rate increases during the drying process, and it may even fail to dry. Comparative Example 9' does not add high ester pectin, and the addition of 0.03% calcium chloride causes the divalent metal ion content in the film-forming composition to reach 0.015%, and the final product is basically unable to form a gel network.

[0162] Table 5

[0163]

[0164]

[0165] Comparative Example 13 uses partially deacylated gellan gum, and the glass transition temperature of its film-forming composition is low, the gel strength is low, the viscosity is large, the molding pill breaking rate increases, and the comprehensive evaluation of the final product is less than 6, which does not meet the requirements of large-scale production. Comparative Examples 14 and 15 only add partially deacylated gellan gum or high acyl gellan gum, and its viscosity is large, the strength is low, and it is basically impossible to drip and form seamless soft capsules. Comparative Example 16 only adds high-ester pectin, and high-ester pectin needs to gel under high coexisting solutes and low pH conditions. In all formulations of the present invention, the water content is in the range of more than 80%, and high-ester pectin cannot form gel under such conditions. Comparative Examples 17 and 18 use partially deacylated gellan gum or high acyl gellan gum in combination with low acyl gellan gum, and the gel strength of its film-forming composition only relies on the gel of partially deacylated gellan gum or high acyl gellan gum itself, and its strength is low, the water medium disintegration time increases, and the product comprehensive evaluation is lower than 6, which is not suitable for large-scale production of seamless soft capsules. Comparative Example 19 uses low acyl gellan gum, sodium alginate, glycerol and water. The disintegration time in the aqueous medium after drying is short, but the gel strength of the film-forming composition is low, the molding pill breakage rate is increased, and the method has a high raw material loss rate and high cost.

[0166] Examples 8-12: Effect of Additives

[0167] According to the formula in Table 6, seamless soft capsules were prepared according to the above method and the performance was tested.

[0168] Table 6

[0169]

[0170]

[0171] In Examples 8-12, sweeteners, flavors, pigments and other additives were added to Example 1, and the resulting soft capsules had a low pill breakage rate, a short aqueous medium disintegration time, a high comprehensive product evaluation, and met the requirements for large-scale production.

[0172] Examples 13-17: Effect of the Second Gelling Agent

[0173] According to the formula in Table 7, seamless soft capsules were prepared according to the above method and the performance was tested.

[0174] Table 7

[0175]

[0176]

[0177] Examples 12-16 are based on Example 1 and add a second gelling agent such as carrageenan, high acyl gellan gum, partially deacylated gellan gum, sodium alginate and agar. The viscosity of the film-forming composition is appropriate and the gel strength is high. The prepared seamless soft capsules have a short disintegration time in aqueous medium. The comprehensive evaluation of the products is higher than 6, which meets the requirements of large-scale production.

[0178] Although the present invention has been described with reference to illustrative embodiments, it will be appreciated by those skilled in the art that various other changes, omissions and / or additions may be made and that elements of the described embodiments may be substituted with substantial equivalents without departing from the spirit and scope of the present invention. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the present invention without departing from the scope of the present invention. Therefore, it is not intended herein to limit the present invention to the specific disclosed embodiments for carrying out the present invention, but rather it is intended that the present invention will include all embodiments within the scope of the appended claims.

Claims

1. A film-forming composition comprising, by weight: 1%-4% first gelling agent; 0.5%-10% high ester pectin; 0.75-15% plasticizer; and At least 80% water, in, The first gelling agent is low acyl gellan gum, Preferably, the content of divalent metal ions in the film-forming composition is insufficient to make the low acyl gellan gum form a gel, and more preferably, the content of divalent metal ions in the film-forming composition is less than 0.015%.

2. The film-forming composition of claim 1, wherein the weight average molecular weight of the high ester pectin is 20,000 to 200,000 Da, and / or the content of the high ester pectin is 0.5%-0.83%, 0.83%-1%, 0.5%-1%, 1%-10% or 0.83%-10%, preferably 0.83%.

3. The film-forming composition according to claim 1 or 2, wherein each repeating unit of the low acyl gellan gum has less than 25% of acetyl groups and less than 15% of glyceryl groups; and / or the content of the first gelling agent is 2%-3%, preferably 2.5%.

4. The film-forming composition according to any one of claims 1 to 3, wherein the plasticizer is selected from glycerol, sorbitol, xylitol, erythritol, maltitol and lactitol, preferably glycerol; and / or the content of the plasticizer is 0.75%-5% or 1%-3%, preferably 2%.

5. The film-forming composition according to any one of claims 1 to 4, further comprising an additive selected from at least one of a sweetener, a pigment, a sunscreen and a flavor, Preferably: The sweetener content is below 2%, more preferably 1%; The pigment content is below 2%, more preferably 0.15%; The fragrance content is below 1%, more preferably 0.1%; and / or The content of the sunscreen agent is below 0.5%, more preferably 0.5%, Preferably: The sweetener is selected from sucralose, neotame, aspartame, alitame, saccharin sodium, acesulfame potassium, psicose, advantame, cyclamate, thaumatin, steviol glycosides, mogroside, isomaltulose, ammonium glycyrrhizinate, monopotassium and tripotassium glycyrrhizinate and D-mannitol; The sunscreen is selected from titanium dioxide, zinc oxide and calcium carbonate; The pigment is selected from allura red, brilliant blue, lemon yellow, sunset yellow, cochineal, turmeric, annatto, gardenia yellow, gardenia blue, amaranth, safflower yellow, vegetable carbon black, carotene and sodium copper chlorophyllin; and / or The flavor is selected from peach flavor, strawberry flavor, cherry flavor, cantaloupe flavor, apple flavor, grape flavor, banana flavor, lemon flavor, jasmine flavor, blueberry flavor, fruit acid flavor, grapefruit flavor, olive flavor and sweet orange flavor.

6. The film-forming composition according to any one of claims 1 to 5, further comprising a second gelling agent selected from the group consisting of carrageenan, high acyl gellan gum, partially deacylated gellan gum, sodium alginate and agar, Preferably, the content of the second gelling agent is 0.1%-0.5% or 0.2%-0.3%, more preferably 0.25%.

7. A seamless soft capsule shell comprising the film-forming composition according to any one of claims 1 to 6; preferably, the water content in the film-forming composition is dried to 6-20 wt%.

8. A seamless soft capsule comprising the seamless soft capsule shell of claim 7 and contents, preferably, the contents are selected from oils, suspensions and emulsions, Preferably, the contents include one or more of chemical drugs, Chinese medicine powder or Chinese medicine extract, plant extract, vegetable oil or animal fat, vitamins, minerals and carotenoids. Preferably, the vegetable oil or animal fat is selected from MCT oil, DHA algae oil, fish oil, linseed oil, rice bran oil, evening primrose oil, borage oil, wheat germ oil, conjugated linoleic acid, ganoderma lucidum spore oil, calyx oil, krill oil, garlic oil, almond oil, perilla seed oil, olive oil, squalene, sesame oil, pumpkin seed oil, safflower seed oil, shea butter, camellia oil, saw palmetto extract oil, walnut oil, castor oil, grape seed oil, cottonseed oil, peanut oil, soybean oil, corn oil, sunflower seed oil, rapeseed oil and palm oil. Preferably, the vitamin is selected from fat-soluble vitamins, preferably, the vitamin is selected from vitamin A, vitamin D, vitamin E and vitamin K, Preferably, the carotenoids are selected from lutein, lutein esters, beta-carotene, lycopene and zeaxanthin.

9. The seamless soft capsule of claim 8, which is prepared by the following method: the method comprises using the film-forming composition of any one of claims 1 to 6 for preparation, preferably, the method comprises sol, dripping and drying steps, wherein (1) Sol: A) mixing the first gelling agent, high ester pectin, plasticizer and water, and stirring until the mixture is uniform; B) heating and stirring the mixture of step A) at 60-98° C. until the colloid is completely dissolved; C) removing bubbles, (2) dripping: the gelatin solution is transported to the dripper of the seamless soft capsule production equipment, the contents are added to the dripper, and the seamless soft capsules are produced by dripping, and the pellets are formed by rotating the cage, and (3) Drying: Drying the capsules until the moisture content of the capsule shell is 6-20%.

10. The seamless soft capsule of claim 8, which is prepared by the following method: the method comprises using the film-forming composition of claim 5 or 6 for preparation, preferably, the method comprises sol, dripping and drying steps, wherein (1) Sol: A) using part of water and / or plasticizer to completely disperse the additives at room temperature, then adding to the remaining water and stirring, then adding the first gelling agent and high ester pectin and stirring until the mixture is uniform; B) heating and stirring at 60-98° C. until the colloid is completely dissolved; C) removing bubbles, (2) dripping: the gelatin solution is transported to the dripper of the seamless soft capsule production equipment, the contents are added to the dripper, and the seamless soft capsules are produced by dripping, and the pellets are formed by rotating the cage, and (3) Drying: Drying the capsules until the moisture content of the capsule shell is 6-20%.

11. A method for preparing seamless soft capsules, comprising using the film-forming composition according to any one of claims 1 to 6 for preparation, preferably, the method comprises sol, dripping and drying steps, wherein (1) Sol: A) mixing the first gelling agent, high ester pectin, plasticizer and water, and stirring until the mixture is uniform; B) heating and stirring the mixture of step A) at 60-98° C. until the colloid is completely dissolved; C) removing bubbles, (2) dripping: the gelatin solution is transported to the dripper of the seamless soft capsule production equipment, the contents are added to the dripper, and the seamless soft capsules are produced by dripping, and the pellets are formed by rotating the cage, and (3) Drying: Drying the capsules until the moisture content of the capsule shell is 6-20%.

12. A method for preparing seamless soft capsules, comprising using the composition of claim 5 or 6 for preparation, preferably, the method comprises sol, dripping and drying steps, wherein (1) Sol: A) using part of water and / or plasticizer to completely disperse the sweetener, pigment, flavor and opacifier at room temperature, and then adding them to the remaining water and stirring, and then adding the first gelling agent and high ester pectin and stirring until the mixture is uniform; B) heating and stirring at 60-98° C. until the colloid is completely dissolved; C) removing bubbles, (2) dripping: the gelatin solution is transported to the dripper of the seamless soft capsule production equipment, the contents are added to the dripper, and the seamless soft capsules are produced by dripping, and the pellets are formed by rotating the cage, and (3) Drying: Drying the capsules until the capsule shell moisture content is 6-20%.

13. Use of the film-forming composition according to any one of claims 1 to 6 or the seamless soft capsule according to any one of claims 8 to 10 in food, medicine and / or cosmetics, preferably, the food is a health food.

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