KR20090130580A - Pharmaceutically stable chewable soft capsule composition - Google Patents

Abstract

PURPOSE: A chewable soft capsule composition is provided to conveniently administer the capsule and improve administration. CONSTITUTION: A chewable soft capsule contains 10-99.7 weight% of pharmacologically active ingredient and functional ingredient, 0.01-20 weight% of perfume, 0.01-20 weight% of sweetener, 0.01-20 weight% of mixture of surfactant, suspending agent or their mixture based on total weight of capsule. The capsule also contains 0.1-60 weight% of starch, 10-80 weight% of gelatin, 1.0-60 weight% of one or two more ingredient among sugar, sugar alcohol or poly valent alcohol, 0.01-10 weight% of sweetener, 0.01-10 weight% of perfume and 10-60 weight% of purified water.

Description

Pharmaceutically Stable Chewable Soft Capsule Composition

FIELD OF THE INVENTION The present invention relates to a pharmaceutically stable chewable soft capsule composition, in particular containing pharmacologically active ingredients or ingredients of functional foods, sweeteners, flavoring agents, and surfactants, suspending agents or mixtures thereof in the contents of the filling. Formulations characterized in that the coating composition of the capsule contains acid treated gelatin, succinate gelatin or mixtures thereof, starch, sweeteners, flavorings, purified water and sugars, sugar alcohols, polyhydric alcohols or two or more selected mixtures thereof. It is related with the chewable soft capsule which is stable.

Representative formulations of current capsules include hard capsules and soft capsules. Soft capsules are formulations that dissolve or suspend one or more pharmacologically active ingredients or ingredients of functional foods in one or more liquid (or semi-solid) excipients to produce liquid or paste-like materials and fill the gelatine coating. to be. The film of the soft capsule is composed of gelatin, plasticizers such as glycerin, sorbitol solution and water, and is prepared by adding colorant, opacifying agent, flavoring agent, preservative, enteric coating agent, etc. as necessary.

Soft capsules are usually taken by swallowing with water into the airway oral cavity. However, soft capsules may cause discomfort depending on children, the elderly, or personal taste, and there is a disadvantage that can not be taken without water.

Chewable forms of soft capsules that can be swallowed by chewing capsules are examples of formulations that improve the disadvantages of ingestion.

By the way, when the soft capsule is consumed as it is chewed, the contents containing most of the pharmacologically active ingredients have problems such as causing an unpleasant taste and aroma, and various aroma or sweetener ingredients to improve the taste and aroma of the contents. Although chewable soft capsules were prepared by the addition, there was a problem such as being unstable chemically due to crosslinking with the gelatin component, which is a coating composition, and interaction with the contents.

Currently, tablet or jelly type is known as a chewable type formulation containing flavor and aroma. Techniques for such formulations discloses delicious chewable tablets incorporating a combination of vanilla and grape flavors for oral administration of cetirizine dihydrochloride in WO2003 / 084511. No. 1998-067711 discloses an improved chewable formulation containing a sugar or juice component in a gelatin base. In addition, as a chewable type soft capsule related technology, glycerin, D-sorbitol solution, a suitable amount of citric acid, and a leading agent having a surface tension-enhancing effect are added to gelatin substrate in Korean Patent Publication No. 10-2004-0008294, and a food coloring compound is formulated. The soft capsule for bad breath removal and oral cleaning produced by the method for producing a bilayer liquid is disclosed. In addition, Korean Patent Publication No. 10-0647034 discloses a patent for a manufacturing method for easily improving chewing properties by manufacturing a thickness of 0.1 to 0.5 mm before drying a soft capsule through a thin film cooling system.

However, the formulations developed so far have focused on simply improving the taste and aroma of the product when chewing, and most of them are simply improving the chewing feeling by thinning the film thickness. Therefore, the capsule disintegration delay, film hardening phenomenon, contents leakage (leak) of the capsule product by interaction with the aldehyde or ketone group present in the amino acid residue of the gelatin, the coating composition of the chewable soft capsule, and various kinds of sugars and additives and flavors Film instability and problems with poor texture during chewing still need to be improved.

The present inventors have studied diligently to minimize the cross-linking between the coating components and interactions with the contents in the filling content and the coating composition of the chewable soft capsule, and as described later in the coating composition and the filling content of the chewable soft capsule, Processed gelatin and succinate gelatin, starch, particularly preferably modified starch, fragrance, sweeteners, surfactants and suspending agents in a soft capsule prepared by the transfer of the disintegration and the main ingredient of the problem of the existing product It is possible to provide a chewable soft capsule that can be prevented, and the chewing feeling is soft and the sticking between the capsules is improved and the leakage and the appearance deformation of the contents are small, so that the chewable soft capsules having excellent preservability can be provided. To discover and complete the present invention.

Accordingly, an object of the present invention is 10 to 99.7% by weight, 0.01 to 20% by weight, 0.01 to 20% by weight of sweeteners, 0.01 to 20% by weight of sweeteners, and surfactants, based on the weight of the filling content of the soft capsule 0.01 to 20% by weight of a suspending agent or a mixture thereof, and 0.1 to 60% by weight starch, 10 to 80% by weight gelatin, sugars (sucrose, sucrose, starch syrup, etc.) based on the weight in the coating composition of the soft capsule, 1.0-60% by weight of one or two or more selected components of sugar alcohols (sorbitol, maltitol, polyglycitol syrup, xylitol), and polyhydric alcohols (glycerine, ethylene glycol, polyethylene glycol, propylene glycol), sweetener 0.01 It is to provide a pharmaceutically stable chewable soft capsule, characterized in that it contains ~ 10% by weight, fragrance 0.01 ~ 10% by weight, and purified water 10 ~ 60% by weight.

A further object of the present invention is 10 to 80% by weight of acid treated gelatin, succinate gelatin or mixtures thereof, 0.1 to 60% by weight, 0.01 to 10% by weight, sweetener 0.01, based on the weight of the coating composition of the soft capsule 1 wt% to 60 wt% of sugar, sugar alcohol, polyhydric alcohol, or 1 to 60 wt% of selected components, and 10 to 60 wt% of purified water. To provide.

A still further object of the present invention is 10 to 99.7% by weight, 0.01 to 20% by weight, 0.01 to 20% by weight of sweetener and 0.01 to 20% by weight of a pharmacologically active ingredient or functional food, based on the weight of the filling content of the soft capsule, surfactant, suspension It is to provide a pharmaceutically stable chewable soft capsule, characterized in that it contains 0.01 to 20% by weight of the agent or a mixture thereof.

The chewable soft capsule of the present invention can be conveniently taken anytime and anywhere without water, has excellent texture during chewing, and improves the feeling of feeling by adding taste and flavor control ingredients. In addition, due to the characteristics of the manufacturing method, since the physicochemical properties of the capsule coating by the pharmacologically active ingredient or functional food component are not changed, the pharmaceutical instability such as disintegration delay, curing phenomenon, and contents leakage (leak) is improved.

 The invention, in one aspect, 0.01 to 20% by weight, preferably 0.01 to 10% by weight, sweetener 0.01 to 20% by weight, preferably 0.01 to 10% by weight, based on the weight in the filling content composition of the soft capsule and 0.01 to 20% by weight, preferably 0.01 to 15% by weight of surfactants, suspending agents or mixtures thereof, and 0.1 to 60% by weight, preferably 2 to 40% by weight, in the coating composition of the soft capsule, 10 to 80% by weight gelatin, preferably 15 to 55% by weight, sugars (sucrose, white sugar, starch syrup, etc.), sugar alcohols (sorbitol, maltitol, polyglycitol syrup, xylitol), or polyalcohols (glycerine, ethylene Glycol, polyethylene glycol, propylene glycol) 1.0 to 60% by weight, preferably 10 to 50% by weight, sweetener 0.01 to 10% by weight, preferably 0.01 to 8% by weight, fragrance 0.01 to 10% by weight, preferably 0.01 to 8% by weight and purified water 10 to 6 It provides a pharmaceutically stable chewable soft capsule, characterized in that it contains 0% by weight, preferably 10 to 40% by weight.

In a further aspect, the present invention, 10 to 80% by weight of acid treated gelatin, succinate gelatin or mixtures thereof, 0.1 to 60% by weight starch, 0.01 to 10% by weight based on the weight of the coating composition of the soft capsule , 0.01 to 10% by weight of sweetener and sugar, sugar alcohol, polyhydric alcohol or one or two or more selected components of 1 to 60% by weight, purified water 10 to 60% by weight of the pharmaceutically acceptable chewable soft capsules It provides a coating composition.

In still another aspect, the present invention provides a pharmacologically active ingredient or 10 to 99.7% by weight, 0.01 to 20% by weight of perfume, preferably 0.01 to 10% by weight, based on the weight of the filling content of the soft capsule , Sweetener 0.01 to 20% by weight, preferably 0.01 to 10% by weight and 0.01 to 20% by weight, preferably 0.01 to 15% by weight of surfactants, suspending agents or mixtures thereof Provide a stable chewable soft capsule.

Gelatin, the most commonly used for soft capsule coatings, is a substance obtained by hydrolyzing collagen, which constitutes the connective tissue of an animal.Polypeptide chain is a polymer in the form of supercoiled polymer. to be. However, such polypeptide chains include highly reactive active groups (-COOH, -NH ₂ , -OH) such as glutamic acid, aspartamic acid, glutamine, hydroxyproline, and the like, and include cysteine, cystine, methionine, and the like. It may also include the -SH group.

The activating groups between the gelatin molecules form covalent bonds over time, gradually forming a large network molecule. Due to this phenomenon, gelatin does not dissolve in water and hardening occurs such that the entire coating of the soft capsule becomes insoluble and delays disintegration. Due to this hardening, chewable soft capsules are hard to chew and chew, very bad chew, and gelatin residues do not melt, making it difficult to remain between teeth or throat.

The formation of the network structure of gelatin molecules can be divided into two types: cross-linking between gelatin components and interaction between gelatin and contents.

First, in the case of crosslinking between the gelatin components, the insolubilization mechanism of the gelatin is mainly carried out by a carbonylamine reaction, which proceeds rapidly when the aldehyde compound is present inside the coating and contains a lot of moisture. In addition, the gelatin self-condensation reaction causes the amino group of the general gelatin itself to react with the carboxyl group to form an amide bond to cause disintegration delay. Formation of amino bonds is accelerated at higher temperatures.

In addition, commonly used filling contents that can affect the formation of networks between gelatin molecules include tannins, minerals and natural sweeteners (e.g. sugars or sugar alcohols such as sorbitol, enzymatically treated steviosides), synthetic sweeteners (e.g. , Acesulfame-K, etc., natural and synthetic flavors (e.g. vanilla and almond flavors with aldehydes; lemon, peppermint and orange flavors with terpene; apricot flavor with lactones) And peach flavors; apple flavors including esters), and excipient components (e.g., alcohols, aldehyde groups or ketone groups included in polyoxyethylene sorbitan fatty acid esters, etc.), In the case of soft capsules containing these ingredients, the entire coating is insoluble, causing a hardening phenomenon such as delayed disintegration and a bad feeling of chewing. You can.

In addition, in the case of a drug formulation having a hydroxyl group, an aldehyde group is formed by oxidation, and the amino group of the aldehyde group and gelatin crosslinks through a carbonylamine reaction to delay disintegration. When iron, chromium, or aluminum ions are transferred to water in the film, they chelate with carboxyl groups in the gelatin molecules to form a network between the gelatin molecules.

The inclusion of a component containing an aldehyde group (-CHO), especially in the contents of the filling, readily reacts with the amino group of ordinary gelatin (-NH ³⁺ ), resulting in aldehyde hydrolysis or self-condensation to form macromolecules with ketone compounds. It is known.

Furthermore, when the filling contents are unsaturated fats or fats and oils, they react with oxygen in the air to form alcohols, aldehydes, or ketones, which react with the free amine groups of the gelatin to cause gelatin disintegration and film hardening.

Such formation of gelatinous macromolecules leads to disadvantages such as delayed disintegration, poor chewing feeling, and formation of residues in chewing, resulting in insoluble properties of soft capsules.

In addition, due to the nature of gelatin, there is a problem in that the stickiness, decolorization of the capsules and the adhesive strength of the adhesive site are reduced, and the capsules are easily ruptured and the contents leak (leak).

The present invention was able to improve the above various problems by adopting the respective components in consideration of the problems of the reactivity between these materials.

The filling content of the chewable soft capsule of the present invention may include, but is not limited to, a pharmacologically active ingredient or a functional food ingredient. It may be particularly suitable to include the contents of vegetable and animal fats and oils, preferably. More preferred filling contents may be pharmacologically active ingredients or functional foods comprising saturated fatty acids, unsaturated fatty acids, special fatty acids, or essential fatty acids. Examples of the most preferred active ingredients include saturated fatty acids having 1 to 30 carbon atoms, unsaturated fatty acids having 4 to 24 carbon atoms having at least one double bond in the molecule, special fatty acids having 4 to 18 carbon atoms, essential fatty acids, and mixtures thereof. . Specific examples include, but are not limited to, refined fish oil, evening primrose oil, jarra oil, borage oil, linseed oil, walnut oil, and the like.

The content of the filling content is preferably included in an amount of 40 (modified to 10) to 99.7% by weight based on the filling content of the capsule.

In the composition of the chewable soft capsule of the present invention, the surfactant has been adopted as a component for masking the malodor of the filling contents. Conventionally, soft capsule products, particularly soft capsule products containing vegetable or animal fats and oils, such as refined fish oil, evening primrose oil, shelled oil, linseed oil, borage oil, walnut oil, are most commonly swallowed with water. In particular, products containing refined fish oil, etc. have a characteristic fishy taste and aroma when ingested with water, and thus have a phenomenon of reflux from the stomach.

The content of the surfactant is preferably included in an amount of 0.01 to 20% by weight, more preferably 0.01 to 10% by weight based on the weight of the filling content composition of the capsule.

The surfactant preferably has an HLB value of 10 or more, and for example, polyoxyethylene sorbitan fatty acid esters, phospholipids, polyoxyethylene stearates, and sorbents. Sorbitan esters, ethoxylated alchol, ethoxylated castor oil or hydrogenated castor oil, ethoxylated stearates, polyethylene glycol-polyoxypropylene copolymers 1 or more types, such as a block copolymer, is mentioned.

More preferably, the surfactant is polyoxyethylene 20 sorbitan monolaurate, polyoxyethylene (4) sorbitan monolaurate, polyoxyethylene 20 sorbitan mono Palmitate (Polyoxyethylene 20 sorbitan monopalmitate), Polyoxyethylene 20 sorbitan monostearate, Polyoxyethylene (4) Polyoxyethylene (4) sorbitan monostearate, Polyoxyethylene 20 Polyoxyethylene 20 sorbitan tristearate, Polyoxyethylene 20 sorbitan monooleate, Polyoxyethylene (5) Polyoxyethylene (5) sorbitan monooleate, Polyoxy Polyoxyethylene 20 sorbitan trioleate, 20 polyoxyethylene Polyoxyethylene 20 sorbitan monoisostearate, sorbitan di-isooctadecanoate, (Z, Z) -sorbitan di-9-octadecanoate ((Z, Z) -sorbitan di-9-octadecanoate, Sorbitan monododecanoate, Sorbitan monoisooctadecanoate, (Z) -Sorbitan mono-9-octadecanoate ((Z ) -Sorbitan mono-9-octadecenoate, Sorbitan monohexadecanoate, Sorbitan mono-octadecanoate, Sorbitan sesqui-isooctadecanoate -isooctadecanoate), (Z) -Sorbitan sesqui-9-octadecanoate ((Z) -Sorbitan sesqui-9-octadecenoate), Sorbitan sesqui-octadecanoate, Sorbitan Sorbitan tri-isooctadecanoate, (Z, Z, Z) -sorbitan Tri-9-octadecenoate ((Z, Z, Z) -Sorbitan tri-9-octadecenoate), and sorbitan tri-octadecanoate can be used selected from the group consisting of, These ingredients include, including trade names, Cremophor EL, Docusate sodium, Labrasol, Nonoxynol-9,10, Octoxynol-9, OEG-100 monostearate, PEG-32 dioleate, PEG-4 monolaulate, PEG-40 monostearate, PEG-8 monolaurate, PEG-8 monostearate, Pluronic F108, Pluronic F127, Pluronic F168, Pluronic F87, Pluronic L44, Poloxamer 188, Poloxamer 235, Polyoxyethylene oleyl ether, Polysorbate 20, Polysorbate 21, Polysorbate 40, Polysorbate 60, Polysorbate 65, Polysorbate 80, Polysorbate 85, Potassium oleate, Sodium oleate, Sucrose monolaurate, Triethanollamine oleate, Glyceryl Monooleate, Phospholipids ).

The fragrance component in the composition of the present invention serves to block odor or mask unpleasant tastes, and specific examples thereof include lemon balm, parsley seed oil, lemongrass oil, fennel, menthol, and the like; Vanilla and almond flavors including aldehydes; Lemon, peppermint and orange flavors with terpene; Apricot and peach flavors containing lactones; It includes one or more of vegetable, animal natural or synthetic flavors such as apple flavor with esters. Their form may be selected from the group consisting of oil or water soluble ingredients of powder or liquid type and combinations thereof.

The fragrance of the above ingredients may be included 0.01 to 20% by weight based on the weight of the filling content, preferably from 0.01 to 10% by weight.

In addition, it is good to be included in 0.01 to 10% by weight based on the weight of the capsule film, preferably it is preferably used in 0.01 to 8% by weight.

The sweetener of the above components is to improve the taste and aroma, sugar or non-sugar natural sweeteners such as sugars, sugar alcohols, enzyme treatment stevioside for sweetness, sugars or non-aspartame, saccharin, acesulfame-K, etc. It is preferable to contain 1 or more types of saccharide synthetic sweeteners.

It is preferable that 0.01 to 20% by weight based on the weight of the filling contents is included, preferably 0.01 to 10% by weight.

In addition, the sweetener is preferably included in 0.01 to 10% by weight based on the weight of the capsule of the capsule, preferably used in 0.01 to 8% by weight.

Specific examples of sweeteners include sugars, glucose, starch syrup, fructose, maltose, lactose, sugars such as xylose, lactose and fructooligosaccharides, sugar alcohols such as sorbitol and maltitol, glycyrrhizin, enzymatically treated steviosides, tomateins and the like. It can be selected from the group consisting of natural sweeteners, including non-saccharide glycosides and proteins, and synthetic sweeteners such as aspartame, saccharin, alitam, acesulfame-K, and combinations thereof.

If the filling content component of the chewable soft capsule comprises a powder, it is preferred to optionally include a suspending agent to ensure homogeneity.

As the suspending agent, for example, glyceryl mono-, di-, tri-fatty acid, bee's wax, animal stearate, hydrogenated vegetable oil ( hydrogenated vegetable oil, partially hydrogenated vegetable oil, and the like.

The suspending agent may be included in an amount of 0.01 to 20% by weight based on the weight of the filling contents, and preferably 0.01 to 15% by weight.

In addition, in the present invention, by using acid-treated gelatin, succinate gelatin or a mixture thereof in the chewable soft capsule coating composition, it is possible to prevent disintegration and curing during long-term storage of the soft capsule, thereby preventing deterioration of texture during chewing. .

Acid-treated gelatin is processed by collecting gelatin from cattle, pigs, poultry, and fish, treating acid, extracting hot water, and filtering, concentrating, and drying.

The method of preparing succinic gelatin is obtained by extracting the hides of cows and pigs, extracting them by acid treatment, filtering, concentrating and drying the succinic acid and then preparing the filtration, concentration and drying processes.

Succinate gelatin has a chemical structure in which the amino group (-NH ³⁺ ) of normal gelatin is succinylated and substituted with a carboxyl group (-COOH). This improved quality is much better than that of ordinary gelatin.

The content of gelatin is preferably included in 10 to 80% by weight based on the weight of the coating, more preferably 15 to 55% by weight.

By containing at least one starch as a film constituent of the chewable soft capsule according to the present invention, it prevents the transition of the water-soluble filling contents (active ingredient) to the film, thereby improving the curing phenomenon, and sticking phenomenon between the capsules during long-term storage. ), And can provide a soft capsule excellent in preservation with little appearance deformation.

The content of starch is preferably included 0.1 to 60% by weight based on the weight of the film, more preferably 2 to 40% by weight. When the ratio of starch exceeds 40% by weight, the viscosity of the composition is low, making the sheet difficult to form due to the difficulty in forming the capsule, and the adhesion between the capsules is remarkably low, resulting in a leaking content. There is a concern that not only the feeling becomes worse and sticking occurs between capsules, but also that the deformation of the capsule becomes severe during long-term storage.

Starch is a polysaccharide composed of glucose, which is contained in large amounts in the form of particles in storage organs such as seeds and rhizomes of higher plants. It is a complex of amylose (20-25%) linked only by α-1,4-bond and amylopectin (75-80%) including side chains of α-1,6 bond.

The natural starch is insoluble in cold water and hot water, and swells and disperses by heating to show geological phenomenon. In addition, the viscosity rises with the progress of gelatinization, it is impossible to maintain a constant viscosity. In addition, as gelatinization is accelerated by stirring and pressure, the viscosity decreases rapidly, and aging occurs due to preservation.

The use of modified starch in the starch is more desirable to overcome the problems of conventional chewable soft capsules. The modified starch is partially polymerized with acid, alkali, salt, oxidizing agent, enzyme or heat to natural starch, or converted into derivative by polymer reaction such as methylation and acetylation. Modified starch has many advantages, especially with improved gel stability, aging stability shear resistance and the like.

Examples of modified starches that may be particularly preferably used in the composition of the present invention include oxidized starch, acetylated distarch adipate, acetylated distarch phosphate, and octenyl sodium starch starch. sodium octenyl succinate, monostarch phosphate, distarch phosphate, phosphated distarch phosphate, starch acetate, hydroxypropyl distarch phosphate, Hydroxypropyl starch, and the like, and natural starch includes, for example, corn starch, potato starch, sweet potato starch, buckwheat starch, barley starch, sorghum starch, wheat starch, tapioca starch, rice starch, and the like. Mixtures may be preferably used. In particular, starch acetate, starch oxide, and corn starch are more preferable.

In the coating composition, one of sugar (sucrose, white sugar, syrup, etc.), sugar alcohol (sorbitol, maltitol, polyglycitol syrup, xylitol), or polyhydric alcohol (glycerine, ethylene glycol, polyethylene glycol, propylene glycol) It is preferred to contain 1.0 or 60% by weight, preferably 10 to 50% by weight of dogs or two or more selected components. The sugar, sugar alcohol or polyhydric alcohol may function as a plasticizer. It acts as a factor that makes gelatin's elasticity prevent hardening of gelatin and maintains flexibility.

Purified water is preferably included in an amount of 10 to 60% by weight, preferably 10 to 40% by weight based on the weight of the coating composition.

The capsule base used in the capsule coat of the present invention may be any material as long as it is a substance which can be used as the base of the soft capsule coat which improves chewability. For example, proteins (gelatin hydrolyzate, collagen, collagen hydrolyzate, casein), polysaccharides (amylase, polygallacturonic acid, agar, carragenan, dalm gum ( Dammar Gum, Tamarind Gum, Guar Gum, Xanthan Gum, Arabic Gum, Gelan Gum, Natural Gum (Masticatory Substances), Karaya Gum ( Karaya Gum, Psyllium Gum, Tara Gum, Tragacanth Gum, Gum Ghatti, Ester Gum, Pectin, Alginic Acid, etc. are preferable. Is available.

The coating composition may further comprise a pigment. The chewable soft capsules of the present invention are ingested by children and the elderly in nature, so it is necessary to use a pigment that is safe for the body. In general, tar and non-tar synthetic coloring agents that are widely used may inhibit the action of digestive enzymes and cause liver and kidney disorders, and some are allergens. In order to improve such a hazard, in the present invention, it is preferable to use natural pigments to represent the color of the coating. Natural pigments are pigments extracted and purified from natural substances and include animal pigments, vegetable pigments and microbial pigments. Animal pigments include cochineal pigments and lac pigments, which are extracted from the dried shells of shellfish and tobacco beetle (Cochinyl), and vegetable pigments are the three pigments of gardenia fruit, gardenia, safflower. Sulfur and beet red, purple sweet potato pigment, paprika, grape skin pigment, red cabbage pigment, rupein pigment, caramel pigment, carrot pigment, black color and the like. In addition, it is possible to use lead, lead, and the like.

The chewable soft capsule composition of the present invention may be prepared in the form of liquid or paste in a conventional manner.

Hereinafter, the present invention will be described in more detail with reference to Examples, but the present invention is not limited to these Examples.

Example 1 Preparation of Chewable Soft Capsules

Next, the filling composition of Table 2 was used as the coating composition of the soft capsule shown in Table 1, and the filling contents of Table 2 were filled and molded to have a content of 1000 mg by using a rotary die method, and then dried to prepare a soft capsule. Table 2 corresponds to unsaturated fatty acid = tablet oil, aldehyde group = lemon flavor, ketone group = aspartame, acesulfame-K.

Composition (% by weight) of the capsule base Ingredient Name Plain Gelatin 1 Regular Gelatin 2 General: Pumpkin = 2: 1 General: Pumpkin Mountain = 1: 1 Succinate Gelatin  Acid Treated Gelatin Plain Gelatin 44 44 29.3 22 Succinate Gelatin 14.7 22 44 Acid treated gelatin 44 glycerin 11 11 11 11 11 Polyglycitol Syrup * 21 15 15 15 15 15 Purified water 35 30 30 30 30 30

Composition: Sorbitol 30-40%, Maltitol 30-40%

Composition of filling contents Ingredient Name  Compounding ratio (%)  Refined Fish Oil 86.5  Lemon scent 0.5  Lemon lime flavored cotton 2.0  Aspartame 0.5  Acesulfame-K 0.2  Lemon flavor powder 2.5  Vitamin C 0.3  Vitamin E 0.5  lecithin 2.0  White lead 5.0

Test Example 1: Characteristic Test of Chewable Soft Capsule

For long-term storage stability experiments of the soft capsules prepared in Example 1, stored for 2 years at room temperature for the first, 6 months, 12 months, 18 months, 24 months and 4 months under accelerated conditions (40 ° C, 75% RH) While preserving, first, 1 month, 2 months, 3 months, 4 months after the disintegration, chew taste and texture experiments were conducted. The results are shown in Tables 3 to 6 below.

Disintegration test method and standards were in accordance with the common standard test method of the Korean Pharmacopoeia and Food Code, and was specifically carried out as follows. Insert one sample into each of the six glass plates and insert the auxiliary plate. The tester was operated at 37 ± 2 ° C with water as the test solution and the sample disintegrated when the residue of the sample was in a glass tube or when it was a soft substance that was not clearly rounded or was a fragment of the capsule coat and recorded the time. do. The common criteria of Korean Pharmacopoeia and Food Code are appropriate when all samples disintegrate within 20 minutes.

Disintegration time of normal gelatin and succinate gelatin (acceleration condition 40 ℃, 75% RH) Gelatin type At the time of manufacture 1 month 2 months 3 months 4 months Plain Gelatin 1 12 minute, 30 seconds 15 minutes 20 minutes 20 minutes or more 20 minutes or more Plain Gelatin 2 8 minute, 20 seconds 10 minutes 13 minutes 20 minutes 20 minutes or more Normal Gelatin: Pumpkin Gelatin = 2: 1 7 minute, 40 seconds 8 minutes 20 seconds 12 minutes 05 seconds 14 minutes 50 seconds 17 minute, 30 seconds Normal Gelatin: Pumpkin Gelatin = 1: 1 7 minute, 10 seconds 8 minutes 10 minutes 20 seconds 13 minutes 15 minutes Succinate Gelatin 6 minute, 50 seconds 7 minute, 05 seconds 9 minute, 10 seconds 11 minute, 05 seconds 13 minutes Acid treated gelatin 7 minute, 50 seconds 8 minute, 14 seconds 13 minute, 05 seconds 15 minute, 10 seconds 18 minutes

Disintegration time of normal gelatin and succinate gelatin (at room temperature) Gelatin type At the time of manufacture 6 months 12 months 18 months 24 months Plain Gelatin 1 12 minute, 30 seconds 20 minutes or more 20 minutes or more 20 minutes or more 20 minutes or more Plain Gelatin 2 8 minute, 20 seconds 20 minutes 20 minutes or more 20 minutes or more 20 minutes or more Normal Gelatin: Pumpkin Gelatin = 2: 1 7 minute, 40 seconds 13 minutes 15 minutes 16 minute, 50 seconds 19 minute, 20 seconds Regular gelatin: Pumpkin acid Latin = 1: 1 7 minute, 10 seconds 10 minutes 13 minutes 14 minutes 16 minutes Succinate Gelatin 6 minute, 50 seconds 8 minutes 10 minutes 12 minutes 15 minutes Acid treated gelatin 8 minutes 00 seconds 12 minutes 50 seconds 16 minutes 2 seconds 16 minute 59 seconds 20 minutes 10 seconds

As can be seen from the above test results, disintegration was improved by adding a plasticizer such as polyglycitol syrup when using general gelatin, and when comparing general gelatin with gelatin succinate and acid treated gelatin, When succinate gelatin and acid treated gelatin were used as capsules having a problem of delayed disintegration, the disintegration problem was improved, and the result was more improved in succinate gelatin than acid treated gelatin.

In addition, the taste and texture at the time of chewing of the normal gelatin and succinic gelatin were compared and the results are shown in the following Tables 5 to 6 (unit: number of testers).

In the chewing texture test, each of the three soft capsules according to Example 1 was taken, and then the subjects were judged to have the best taste and texture among the chewable soft capsules prepared in Example 1 for 30 subjects. The choice was made.

Acceleration condition [40 ℃, 75% RH] (Unit: Number of testers) Gelatin type At the time of manufacture 1 month 2 months 3 months 4 months Plain Gelatin 1 0 0 0 0 0 Plain Gelatin 2 0 0 0 0 0 Regular Gelatin: Pumpkin Gelatin = 2: 1 0 0 0 0 0 Regular Gelatin: Pumpkin Angel Latin = 1: 1 2 2 One 0 0 Succinate Gelatin 20 20 13 27 28 Acid treated gelatin 8 8 6 3 2

Room temperature conditions (unit: number of testers) Gelatin type At the time of manufacture 6 months 12 months 18 months 24 months Regular Gelatin 1 0 0 0 0 0 Regular Gelatin 2 0 0 0 0 0 Regular Gelatin: Pumpkin Gelatin = 2: 1 One One 0 0 0  Regular gelatin: Pumpkin gelatin = 1: 1 2 2 One 0 0  Succinate Gelatin 19 20 22 24 26  Acid treated gelatin 8 7 7 6 4

As can be seen from the above experimental results, when comparing general gelatin, acid-treated gelatin, succinate gelatin, succinate gelatin had the best taste and texture during chewing, followed by acid-treated gelatin and the worst texture It was a soft capsule prepared using ordinary gelatin. In addition, as the concentration of succinate gelatin increases, chewing feeling was obtained.

Example 2: Preparation of Coating Composition

Glycerin 320g, polyglycitol syrup 100g, starch oxide 80g was added to 220 g of purified water, mixed and stirred. Then, 260 g of succinate gelatin was added and warmed to 60-80 ° C.

20 g of purified water and 4 g of citric acid, 4 g of aspartame, acesulfame-K 1.6 g, and 15 g of cacao pigment were completely dissolved in a separate container, and 7.5 g of peppermint flavoring oil (oil) was added and mixed (mixture 2).

The formulations 1 and 2 were dispersed homogeneously by vigorous stirring 30 minutes before molding, and then the pressure was removed to complete the composition for the coating of the soft capsule according to the present invention.

Examples 3 to 4: Preparation of Coating Composition

According to the method of Example 2, the composition for coating of the soft capsule was prepared as the compounding ratio of each component is shown in following Tables 7-8. (Weight in the following table refers to the weight of the cell before drying.)

     ingredient     Content (g) Formulation 1 Succinate Gelatin 300 glycerin 280 Polyglycitol Syrup 120 Purified water 180 Acetic acid starch 120 Formulation 2 Citric acid 10 Thomas Martin 5 Acesulfame-K 0.5 Orange Flavoring Flavor (Oil) 10 Gardenia Yellow 10

     ingredient     Content (g) Formulation 1 Succinate Gelatin 320 glycerin 280 Polyglycitol Syrup 100 Purified water 200 Modified starch 100 Formulation 2 Citric acid 8 Saccharin Sodium 0.5 Stevioside 0.5 Natural Lemon Flavoring Agent (Oil) 8 Safflower yellow 13

Comparative Example 1: Preparation of Coating Composition for Soft Capsule

300 g of glycerol, 80 g of polyglycitol syrup, and 304 g of succinate gelatin were added to 316 g of purified water, and heated to 60 to 80 ° C., followed by stirring under reduced pressure to melt and swell (compound 1). 15 g of purified water and 5 g of citric acid, 0.5 g of sodium saccharin, 0.5 g of stevioside, and 13 g of yellow safflower were added to a separate container and completely dissolved by adding 10 g of lemon flavoring oil (mixture 2). The formulations 1 and 2 were vigorously stirred and homogeneously dispersed 30 minutes prior to molding, and then the pressure was removed to remove the air bubbles, thereby completing the composition for coating the soft capsule according to the present invention.

Comparative Example 2: Preparation of Coating Composition for Soft Capsule

According to the method of Comparative Example 1, the composition for film coating of the soft capsule was prepared as shown in Table 9 below.

     ingredient     Content (g) Formulation 1 gelatin 280 glycerin 300 Polyglycitol Syrup 100 Purified water 320 Formulation 2 Orange Flavoring Flavor (Oil) 8 Citric acid 10 Thomas Martin 3 Acesulfame-K 0.5 Gardenia Yellow 10 Gardenia Yellow 15

Test Example 2: Physical property test of soft capsule

Solution 1 was prepared by dissolving 120 mg of coconut oil and 40 mg of lead. In a separate container, 420 mg of medium chain fatty acid triglyceride (MCT), 10 mg of lecithin, 38 mg of lemon flavourant, and 600 mg of sorbitol are mixed and stirred while adding the solution 1, and the contents are milled and defoamed to make the filling contents. This was prepared in the usual manner and then used in the test examples for each of the following details.

Test Example 2-1: Long-term Storage Stability Test

In the soft capsules according to Examples 2 to 4, Comparative Examples 1 and 2, the hardness, burst strength, disintegration, appearance and texture at the time of initial, 6 months, 12 months and 24 months while being stored at room temperature for 2 years Stability test was conducted over 6 items of adhesive thickness.

Test Example 2-2: Hardness Test

After taking six soft capsules according to Examples 2 to 4, Comparative Examples 1 and 2, respectively, the hardness was measured using a Varis hardness tester (U-73). The average value of the measured hardness is shown in Table 10.

Hardness test result (Unit: Newton / 20 seconds) first 6 months 12 months 24 months Example 2 2.3 2.1 2.2 2.2 Example 3 1.8 1.7 1.8 1.8 Example 4 1.7 1.6 1.7 1.6 Comparative Example 1 3.5 0.9 0.5 0.4 Comparative Example 2 3.6 2.0 0.8 0.6

As can be seen from the experimental results of Table 10, the soft capsules according to Examples 2 to 4 are maintained in the initial hardness with little change in hardness even after two years, the soft capsules according to Comparative Examples 1 and 2 In the case of, the hardness decreased rapidly after one year.

Test Example 2-3: Film thickness measurement test

About the capsules manufactured in Examples 2-4 and Comparative Examples 1-2, the capsule film thickness (both sides, an initial joint part, and a final joint part) was measured according to the following method. (1) Cut the capsule into short diameters to remove the contents, and then wash with volatile organic solvents such as acetone and alcohol. (2) It is allowed to stand until the solvent volatilizes at room temperature. (3) Observe the cross section upward with an optical microscope, measure the film thickness of the five capsules on the basis of the scale, and calculate the average value.

Film thickness test result (unit: mm) Example 2 Example 3 Example 4 Comparative Example 1 Comparative Example 2 Both side thickness (mm) 0.508 0.512 0.521 0.203 0.246 Initial joint thickness (mm) 0.597 0.603 0.599 0.288 0.258 Final junction thickness (mm) 0.489 0.499 0.485 0.211 0.203

As can be seen from the results of Table 11, the capsule containing the starch prepared according to Examples 2 to 4 has a film adhesion thickness of 0.4 to 0.6 mm, so that the adhesion between the coatings was good, so that no contents leaked out. The capsules prepared according to 1 and 2 had an outflow of contents with a film thickness of 0.2 mm.

Test Example 2-4: Burst Strength Measurement Test

After taking three soft capsules according to Examples 2 to 4, Comparative Examples 1 and 2, respectively, the bursting strength was measured using a burst strength meter (No. 174886) of Jujihara Seisakusho. The average value of the measured burst strength is shown in Table 3.

Burst Strength Test Result Table (Unit: Kg) first 6 months 12 months 24 months  Example 2 18 18 17 15  Example 3 18 17 17 16  Example 4 20 20 19 18  Comparative Example 1 15 11 8 4  Comparative Example 2 16 10 6 5

As can be seen from the experimental results of Table 12, the soft capsules according to Examples 2 to 4 were maintained unchanged in the initial strength even after two years, but the soft capsules according to Comparative Examples 1 and 2 In case of long term preservation, the strength decreased rapidly.

Test Example 2-5: Appearance Test

In Examples 2 to 4, Comparative Examples 1 and 2, each of 100 different soft capsules was subjected to an external appearance test for 2 years at room temperature, and the results are shown in Table 13.

Appearance test result table (discoloration, the number of deformations) first 6 months 12 months 24 months Example 2 0 0 0 0 Example 3 0 0 0 0 Example 4 0 0 0 0 Comparative Example 1 0 3/100 70/100 100/100 Comparative Example 2 0 0 30/100 48/100

As can be seen from the results in Table 13, the soft capsules according to Examples 2 to 4 retained their initial appearance with little change in appearance even after two years, but in the case of soft capsules according to Comparative Examples 1 and 2. There were many capsules that caused deformation and discoloration during long-term preservation.

Test Example 2-6: Texture Test at Mastication

After taking three soft capsules according to Examples 2 to 4, Comparative Examples 1 and 2, respectively, the flavor of the chewable soft capsules prepared in Examples 3 to 5, Comparative Examples 1 and 2, respectively, for 30 people We decided to choose the best one in texture.

Taste and texture test results during chewing (unit: number of testers) first 6 months 1 year 2 years flavor Texture flavor Texture flavor Texture flavor Texture Example 2 9 10 11 10 10 9 9 10 Example 3 12 8 9 9 9 10 9 9 Example 4 9 11 10 11 11 11 12 11 Comparative Example 1 0 0 0 One 0 0 0 0 Comparative Example 2 0 One 000 0 0 0 0 0

As can be seen from the results of Table 14, the soft capsules according to Examples 2 to 4 were superior in taste and texture in comparison with the soft capsules according to Comparative Examples 1 and 2 even after two years.

In the following examples, the main components include vegetable and animal fats and oils such as saturated fatty acids having 1 to 30 carbon atoms, at least one double bond in a molecule, unsaturated fatty acids having 4 to 24 carbon atoms, special fatty acids having 4 to 18 carbon atoms, and essential fatty acids. It is an embodiment showing the result of improving the taste and aroma by adding sweetener and flavoring to the filling contents.

Example 5 Preparation of Soft Capsules Containing Refined Fish Oil

The contents of the soft capsule were prepared as shown in the following table by the blending ratio of each of the contents components containing refined fish oil as a main component.

Example 5-1   ingredient  Weight (g) Formulation 1 Refined Fish Oil 92.65 Beeswax 6.0 lecithin 0.5 Aspartame 0.2 Acesulfame-K 0.05 Vitamin c 0.1 Orange flavor 0.2 Lemon scent 0.3

Example 5-2   ingredient  Weight (g) Formulation 2 Refined Fish Oil 91.7 Beeswax 6.0 lecithin 0.5 Aspartame 0.5 Acesulfame-K 0.2 Vitamin c 0.2 Orange flavor 0.4 Lemon scent 0.2

Example 5-3   ingredient  Weight (g) Formulation 3 Refined Fish Oil 90.3 Beeswax 6.0 lecithin 0.5 Aspartame 0.7 Acesulfame-K 0.3 Vitamin c 0.4 Orange flavor 1.0 Lemon scent 0.8

Example 5-4   ingredient  Weight (g) Formulation 4 Refined Fish Oil 90.2 Beeswax 6.0 lecithin 0.5 Aspartame 1.0 Acesulfame-K 0.05 Vitamin c 0.1 Orange flavor 0.2 Lemon scent 0.3

In order to test the taste and aroma preference of the contents, the contents having the composition ratios of Examples 5-1 to 5-4 were selected for 30 people, which were judged to be excellent in taste and aroma, respectively.

Contents Taste, Flavor Preference Result Table (Unit: Number of Testers) Example 5-1 Example 5-2 Example 5-3 Example 5-4   preference 3 25 2 0

Taste and aroma preference test according to the content composition ratio As a result, the composition ratio of Example 5-2 is determined to have the best taste and aroma preference, 0.2 ~ 0.7% by weight of aspartame of the contents of the contents, Acesulfame-K 0.05 A composition ratio of 0.3% by weight to 0.2% to 1.0% by weight of the orange flavor of the fragrance component was found to be particularly preferred.

Example 6 Preparation of a Soft Capsule Comprising Evening Primrose Seed Oil.

The coating composition of the soft capsule was prepared as the compounding ratio of each filling content component which contains evening primrose seed oil as a main component as follows.

Example 6-1   ingredient  Weight (g) Formulation 1 Evening Primrose Oil 92.65 White lead 6.0 Polysorbate 80 0.5 Enzyme Treatment Stevioside 0.2 Acesulfame-K 0.05 Vitamin c 0.1 Strawberry flavor 0.2

Example 6-2   ingredient  Weight (g) Formulation 2 Evening Primrose Oil 91.7 White lead 6.0 Polysorbate 80 0.5 Enzyme Treatment Stevioside 0.5 Acesulfame-K 0.2 Vitamin c 0.2 Strawberry flavor 0.6

Example 6-3   ingredient  Weight (g) Formulation 3 Evening Primrose Oil 90.3 White lead 6.0 Polysorbate 80 0.5 Enzyme Treatment Stevioside 0.7 Acesulfame-K 0.3 Vitamin c 0.4 Strawberry flavor 1.2

Example 6-4   ingredient  Weight (g) Formulation 4 Evening Primrose Oil 90.2 White lead 6.0 Polysorbate 80 0.5 Enzyme Treatment Stevioside 1.0 Acesulfame-K 0.5 Vitamin c 0.4 Strawberry flavor 1.6

In order to test the taste and aroma preference of the contents, the contents having the composition ratios of Examples 6-1 to 6-4 were selected for 30 people, which were judged to be excellent in taste and aroma, respectively.

Contents Taste, Flavor Preference Result Table (Unit: Number of Testers) Example 6-1 Example 6-2 Example 6-3 Example 6-4 preference 3 26 One 0

Taste and aroma preference test according to the content composition ratio, the composition ratio of Example 6-2 is determined to have the best taste and aroma preference, 0.2 ~ 0.7% by weight of the enzymatic treatment stevioside of the taste component, acesulfame A composition ratio of -K 0.05 to 0.3% by weight and strawberry flavor of 0.2 to 1.2% by weight was preferred.

Example 7 Preparation of Soft Capsules Containing Sola Oil

The contents of the soft capsule were prepared by blending the contents of each of the contents, which contained jara oil as a main ingredient, as follows.

Example 7-1   ingredient  Weight (g) Formulation 1 Jarayu 92.7 Soybean Cured Oil 6.0 Polysorbate 80 0.5 Aspartame 0.3 Vitamin c 0.1 Yogurt flavor 0.2 Vanilla flavor 0.2

Example 7-2   ingredient  Weight (g) Formulation 2 Jarayu 91.7 Soybean Cured Oil 6.0 Polysorbate 80 0.5 Aspartame 0.6 Vitamin c 0.2 Yogurt flavor 0.6 Vanilla flavor 0.4

Example 7-3   ingredient  Weight (g) Formulation 3 Jarayu 90.6 Soybean Cured Oil 6.0 Polysorbate 80 0.5 Aspartame 0.9 Vitamin c 0.4 Yogurt flavor 1.0 Vanilla flavor 0.6

Example 7-4   ingredient  Weight (g) Formulation 4 Jarayu 89.7 Soybean Cured Oil 6.0 Polysorbate 80 0.5 Aspartame 1.2 Vitamin c 0.4 Yogurt flavor 1.4 Vanilla flavor 0.8

In order to test the taste and aroma preference of the contents, the contents having the composition ratios of Examples 7-1 to 7-4 were selected for 30 people, each of which was judged to have excellent taste and aroma.

Contents Taste, Flavor Preference Result Table (Unit: Number of Testers) Example 7-1 Example 7-2 Example 7-3 Example 7-4 preference 4 25 One 0

Taste and aroma preference test according to the content composition ratio As a result of the experiment, the composition ratio of Example 7-2 is determined to have the best taste and aroma preference, the content of aspartame 0.2 ~ 0.9% by weight, yogurt flavor 0.2 of the flavor component A composition ratio of ˜1.0 wt% and vanilla flavor 0.2 to 0.6 wt% was found to be preferred.

Example 8 Preparation of Soft Capsules Including Borage Oil

The contents of the soft capsule were prepared by blending the contents of each of the contents containing borage oil as a main component as follows.

Example 8-1   ingredient  Weight (g) Formulation 1 Borage 92.9 Beeswax 6.0 Soybean Cured Oil 0.5 Enzyme Treatment Stevioside 0.3 Vitamin c 0.1 Grape 0.2

Example 8-2   ingredient  Weight (g) Formulation 2 Borage 92.1 Beeswax 6.0 Soybean Cured Oil 0.5 Enzyme Treatment Stevioside 0.6 Vitamin c 0.2 Grape 0.6

Example 8-3   ingredient  Weight (g) Formulation 3 Borage 91.2 Beeswax 6.0 Soybean Cured Oil 0.5 Enzyme Treatment Stevioside 0.9 Vitamin c 0.4 Grape 1.0

Example 8-4   ingredient  Weight (g) Formulation 4 Borage 90.5 Beeswax 6.0 Soybean Cured Oil 0.5 Enzyme Treatment Stevioside 1.2 Vitamin c 0.4 Grape 1.4

For the taste and aroma preference test of the contents, the contents having the composition ratios of Examples 8-1 to 8-4 were selected for thirty persons, each of which was judged to have excellent taste and aroma.

Contents Taste, Flavor Preference Result Table (Unit: Number of Testers) Example 8-1 Example 8-2 Example 8-3 Example 8-4 preference 4 23 3 0

Taste and aroma preference test according to the content composition ratio, the composition ratio of Example 8-2 is determined to have the best taste and aroma preference, 0.2 ~ 0.9% by weight of the flavor component of the enzyme component stevioside, Composition ratios of 0.2% to 1.0% by weight of grapes were found to be preferred.

Example 9 Preparation of Soft Capsules Containing Flax Seed Oil

The intracapsular composition of the soft capsule was prepared as follows by blending the proportions of each of the contents components containing linseed oil as a main component.

Example 9-1   ingredient  Weight (g) Formulation 1 Linseed oil 92.9 Polysorbate 80 0.5 Thomas Martin 0.3 Lactic acid 0.1 Grape 0.2

Example 9-2   ingredient  Weight (g) Formulation 2 Linseed oil 92.1 Polysorbate 80 0.5 Thomas Martin 0.6 Lactic acid 0.2 Grape 0.6

Example 9-3   ingredient  Weight (g) Formulation 3 Linseed oil 91.2 Polysorbate 80 0.5 Thomas Martin 0.3 Lactic acid 0.4 Grape 1.0

Example 9-4   ingredient  Weight (g) Formulation 4 Linseed oil 90.5 Polysorbate 80 0.5 Thomas Martin 0.6 Lactic acid 0.4 Grape 1.4

For the taste and aroma preference test of the contents, the contents having the composition ratios of Examples 9-1 to 9-4 were selected for thirty persons, which were judged to be excellent in taste and aroma, respectively.

Contents Taste, Flavor Preference Result Table (Unit: Number of Testers) Example 1-1 Example 1-2 Example 1-3 Example 1-4 preference 7 19 One 3

Taste and aroma preference test according to the content composition ratio, the composition ratio of Example 9-2 is determined to have the best taste and aroma preference, 0.3 ~ 0.6% by weight of the flavor component of the contents, grape flavor of the flavor component Composition ratios of 0.2 to 1.0% by weight were found to be preferred.

As described above, in the filling contents and film composition of the chewable soft capsule of the present invention, one or more flavor raw materials, synthetic sweeteners or natural sweeteners corresponding to vegetable or animal natural flavors and synthetic flavors, among the sugar sweeteners and non-sugar sweeteners One or more types were used, and surfactants having an HLB value of 10 or more were added to mask the contents and the taste of the coating. In addition, a suspending agent was used to ensure homogeneity. Also, the coating composition was subjected to acid treatment of gelatin or succinate gelatin to minimize the crosslinking between the coating components and the interaction with the contents. Migration can be prevented, and the addition of starch softens chewing chewing (chewing) and improves sticking between capsules.

Claims (16)

10 to 99.7 weight% of ingredients of pharmacologically active ingredients or functional foods, 0.01 to 20 weight% of flavors, 0.01 to 20 weight% of sweeteners and surfactants, suspending agents or mixtures thereof by weight in the filling contents of the soft capsules 20 to 20% by weight, and 0.1 to 60% by weight starch, 10 to 80% by weight gelatin, one or two or more selected components of sugar, sugar alcohol or polyalcohol by weight in the coating composition of the soft capsule A pharmaceutical stable chewable soft capsule, characterized in that it contains by weight, 0.01 to 10% by weight sweetener, 0.01 to 10% by weight perfume and 10 to 60% by weight purified water. 2. A pharmaceutically stable chewable capsule according to claim 1, wherein said pharmacologically active ingredient or functional food ingredient comprises a filling content of a vegetable or animal fat or oil. 3. The chewable soft capsule according to claim 2, wherein the pharmacologically active ingredient or functional food ingredient is a pharmacologically active ingredient or functional food comprising a saturated fatty acid, unsaturated fatty acid, special fatty acid, or essential fatty acid. The method of claim 2, wherein the pharmacologically active ingredient or functional food component is a saturated fatty acid having 1 to 30 carbon atoms, unsaturated fatty acids having 4 to 24 carbon atoms having at least one double bond in the molecule, special fatty acids having 4 to 18 carbon atoms, And at least one component selected from the group consisting of essential fatty acids and mixtures thereof. The method of claim 1, wherein the surfactant is polyoxyethylene sorbitan fatty acid esters (phospholipids), phospholipids (polyoxyethylene stearates), sorbitan esters (sorbitan esters), ethoxylation Ethoxylated alchol, ethoxylated castor oil or hydrogenated castor oil, ethoxylated stearates, polyethylene glycol-polyoxypropylene copolymers and block copolymers, and mixtures thereof A pharmaceutically stable chewable soft capsule comprising at least one selected from the group consisting of: The method according to claim 5, wherein the surfactant is polyoxyethylene 20 sorbitan monolaurate, polyoxyethylene (4) sorbitan monolaurate, polyoxyethylene 20 Sorbitan monopalmitate, polyoxyethylene 20 sorbitan monostearate, polyoxyethylene (4) sorbitan monostearate, polyoxyethylene 20 sorbitan monostearate Polyoxyethylene 20 sorbitan tristearate, Polyoxyethylene 20 sorbitan monooleate, Polyoxyethylene (5) Sorbitan monooleate (Polyoxyethylene (5) sorbitan monooleate ), Polyoxyethylene 20 sorbitan trioleate, Polyoxyethylene 20 Polyoxyethylene 20 sorbitan monoisostearate, Sorbitan di-isooctadecanoate, (Z, Z) -Sorbitan di-9-octadecanoate ((Z, Z ) -sorbitan di-9-octadecanoate, Sorbitan monododecanoate, Sorbitan monoisooctadecanoate, (Z) -Sorbitan mono-9-octadecanoate (( Z) -Sorbitan mono-9-octadecenoate, Sorbitan monohexadecanoate, Sorbitan mono-octadecanoate, Sorbitan sesqui-isooctadecanoate sesqui-isooctadecanoate), (Z) -sorbitan sesqui-9-octadecanoate ((Z) -Sorbitan sesqui-9-octadecenoate), sorbitan sesqui-octadecanoate, sorb Sorbitan tri-isooctadecanoate, (Z, Z, Z) -Sor A pharmaceutical formulation selected from the group consisting of tantri-9-octadecenoate ((Z, Z, Z) -Sorbitan tri-9-octadecenoate), and sorbitan tri-octadecanoate Stable chewable soft capsule.        The method of claim 1, wherein the suspending agent is glyceryl mono-, di-, tri-fatty acid, bee's wax, animal stearate, hydrogenated vegetable oil, and partially hydrogenated vegetable oil. Pharmaceutically stable chewable soft capsules selected from the group consisting of hydrogenated vegetable oil). 2. The pharmaceutically stable chewable capsule of claim 1, wherein the fragrance is natural or synthetic fragrance. The method of claim 1, wherein the sweetener is a pharmaceutically stable chewable soft capsules selected from the group consisting of sugars, sugar alcohols, non-saccharide glycosides, natural sweeteners and synthetic sweeteners including proteins, and mixtures thereof. The method of claim 1, wherein the starch is oxidized starch, acetylated distarch adipate, acetylated distarch phosphate, starch sodium octenyl succinate, phosphoric acid Monostarch phosphate, distarch phosphate, phosphated distarch phosphate, starch acetate, hydroxypropyl distarch phosphate, hydroxypropyl starch starch) selected from the group consisting of modified starch, corn starch, potato starch, sweet potato starch, buckwheat starch, barley starch, sorghum starch, wheat starch, tapioca starch, rice starch, and natural starch selected from the group consisting of Pharmaceutically stable chewable capsules. 10 to 80% by weight of acid treated gelatin, succinic gelatin or mixtures thereof, 0.1 to 60% by weight, 0.01 to 10% by weight, 0.01 to 10% by weight, sweeteners 0.01 to 10% by weight and sugars, based on the weight of the coating composition of the soft capsule, A coating composition of a pharmaceutically acceptable chewable soft capsule, comprising 1 to 60% by weight of sugar alcohol, one or more polyhydric alcohols, or 10 to 60% by weight of purified water. The method of claim 11, wherein the base of the coating protein, polysaccharides, polygalacturonic acid (polygalacturonic acid), agar (agar), carragenan (Carragenan), Dammar Gum, Tamarind Gum, Guar Guar gum, Xanthan Gum, Arabic Gum, Gelan Gum, Natural Gum, Masticatory Substances, Karaya Gum, Psyllium Gum, Tara Tara Gum, Tragacanth Gum, Gum Ghatti, Ester Gum, Pectin, Alginic Acid, and mixtures thereof The composition for the film of the chewable soft capsule containing the above components. 12. The composition according to claim 11, further comprising a cochineal pigment and a lac pigment obtained by extracting from a natural substance in addition to the coating composition and extracting from a dried body of shellworms and cockroach (Cochinyl) as tablets. Animal pigment selected from the group, Gardenia fruit, the three pigments obtained from gardenia sulfur, gardenia blue, safflower yellow and beet red, purple sweet potato pigment, paprika, grape skin pigment, red cabbage pigment, loupein pigment, black color group Pharmaceutically stable chewable soft capsules comprising at least one pigment component selected from caramel pigments, carrot pigments, vegetable pigments and microbial pigments selected from among. 10 to 99.7% by weight of the pharmacologically active ingredient or functional food, 0.01 to 20% by weight, 0.01 to 20% by weight of sweeteners and surfactants, suspending agents or mixtures thereof, based on the weight of the filling contents of the soft capsule A pharmaceutically stable chewable soft capsule, comprising: by weight. The pharmaceutically stable chewable soft capsule of claim 14, wherein the fragrance is natural or synthetic fragrance. 15. The pharmaceutically stable chewable capsule of claim 14, wherein the sweetener is selected from the group consisting of sugars, sugar alcohols, non-saccharide glycosides, natural sweeteners and synthetic sweeteners including proteins, and mixtures thereof.