KR100905028B1 - Edible Film - Google Patents

Abstract

The present invention relates to an edible film composition comprising a waxy starch hydrolyzate, a modified starch and a water soluble polymer, an edible film comprising the same and a snow soluble preparation. The edible film of the present invention has excellent film formability, has excellent solubility and fineness in the oral cavity, and can be easily manufactured at low cost, so that the oral detergent or bad breath remover for cleanliness in the oral cavity and the absorption of the drug in the oral cavity are excellent. It can be usefully used as a snow soluble preparation for.

Edible film, waxy starch hydrolyzate, modified starch, water soluble polymer

Description

Edible Film

The present invention relates to an edible film composition and an edible film comprising a waxy starch hydrolyzate, modified starch and a water soluble polymer.

In general, an edible film is prepared by adding plasticizers, emulsifiers, sweeteners, acidulants, flavoring agents and other additives based on water-soluble polymers such as pullulan, sodium alginate, pectin, gelatin, carrageenan, xanthan gum, locust bean gum, and the like.

US Patent Publication No. 2005/0031675 discloses a soluble edible film using pullulan as a film forming material, and US Pat. No. 6,656,493 discloses a water soluble edible film comprising sodium alginate and maltodextrin. US Pat. No. 6,709,669 describes a soluble edible film prepared using gelatin, US Pat. No. 7,132,113 uses an edible film comprising hydroxypropyl cellulose and modified starch, US Pat. No. 6,419,903 uses hydroxypropylmethyl. An edible film comprising cellulose and pregelatinized starch is disclosed, respectively.

These conventional techniques disclose edible films made of water-soluble polymers, but these water-soluble polymers have excellent film-forming ability, but are very expensive, supply is not smooth, and the dissolution rate in the oral cavity is slow. There is a problem to use as a drug carrier for administration.

In order to overcome the problems of the soluble edible film according to the prior art, US Patent No. 6,528,088 discloses a film containing a starch and a plasticizer, Japanese Patent Laid-Open No. 2005306960, a high amylose modified starch and a general modified starch and gel A soluble edible film comprising a topical agent is disclosed.

However, the above-mentioned edible film of US Patent No. 6,528,088 has a high sensory foreign matter because a large amount of plasticizer is used together with a high molecular weight starch and modified starch. In addition, the edible film of JP2005306960A has a film forming ability in which a gelling agent and a plasticizer are added to a mixture of high amylose-modified starch and ether-modified starch or maltodextrin. There is a lack of solubility in the oral cavity and it is remarkably sensual.

In addition, the starch and modified starch used in the above-described US Patent No. 6,528,088 and Japanese Patent Laid-Open No. 2005306960 not only have an inconvenience in operation due to aging in an aqueous solution at room temperature, but also a gel formed by aging when the storage time is long in a storage tank. This filter net is blocked or included in the film being produced, causing film quality problems.

The present invention is to provide an edible film composition and an edible film comprising the same that can be produced in a low time in the oral cavity and excellent film formability, excellent microporous and low cost.

The present invention provides an edible film composition comprising a waxy starch hydrolyzate, modified starch, and a water-soluble polymer, an edible film comprising the same, and a method of manufacturing the same.

The edible film of the present invention has excellent film formability, has excellent solubility and fineness in the oral cavity, and can be easily manufactured at low cost, so that the oral detergent or bad breath remover for cleanliness in the oral cavity and the absorption of the drug in the oral cavity are excellent. It can be usefully used as a snow soluble preparation for.

The present invention provides an edible film composition comprising a waxy starch hydrolyzate, modified starch and a water-soluble polymer and an edible film comprising the same.

In the present invention, waxy starch hydrolysate means a hydrolyzate of waxy starch. Here, the waxy starch means a starch having a higher content of amylopectin than an amylose content, and preferably means a starch including amylopectin of 80% or more, more preferably 90% or more. Waxed starch may be, but is not limited to, for example, starch derived from one or more plants selected from the group consisting of rice, wheat, sweet potatoes, potatoes, corn and tapioca, and may be readily obtained by genetic manipulation or hybridization. have.

 The waxy starch hydrolyzate may be formed by acid treatment or enzymatic treatment of waxy starch. In addition, in order to increase the aging stability, the oxidized, etherified or esterified waxy starch may be acid treated or enzymatically treated, or the acid treated or enzyme treated waxy starch may be oxidized, etherified or esterified.

The acid treatment can be performed by organic or inorganic acid treatment. For example, waxy starch can be hydrolyzed by treating organic acids such as acetic acid, formic acid, citric acid, malic acid, or inorganic acids such as hydrochloric acid, sulfuric acid, phosphoric acid, and the like.

The enzyme treatment can be carried out by one or more enzymes selected from the group consisting of, for example, alpha amylase, heat resistant alpha amylase, fluranase, isoamylase, glucoamylase and beta amylase.

Conventionally, when starch is used as a film former, general starch, waxy starch, or high amylose starch has been used. However, while high amylose starch has excellent film forming ability, it has very low oral solubility and sensory slippery, and waxy starch is less sensory slippery but significantly lower film forming ability. General starch has a disadvantage in that the film forming ability is lower than high amylose starch, and the slipperiness is severe compared to waxy starch. In the present invention, the hydrolyzate of waxy starch is used as a film forming agent to compensate for these disadvantages. As can be seen in the examples below, the waxy starch hydrolyzate is very soluble in the oral cavity and is not functionally slippery.

The 20% solution of the waxy starch hydrolyzate preferably has a viscosity of 500 to 5000 cps. If it is lower or higher than this, the film forming ability is poor. The viscosity is measured by stirring 80% by weight of water and 20% by weight of waxy starch hydrolyzate using a Brookfield viscometer at 40 ° C.

On the other hand, modified starch refers to starch modified through one or more modification reactions, such as oxidation reaction, esterification reaction, etherification reaction, crosslinking reaction, alphalation reaction.

In one embodiment, the modified starch is oxidized starch, acetyladipic acid starch, acetyl phosphate starch, octenyl succinyl sodium starch, octenyl succinyl starch, octenyl phosphate starch, monophosphate starch, phosphate starch phosphate It may be at least one starch selected from the group consisting of starch acetate, starch oxide acetate, hydroxyethyl starch, hydroxypropyl phosphate starch and hydroxypropyl starch. Preferably, the modified starch may be at least one starch selected from the group consisting of starch oxide, octenylsuccinyl sodium starch, low viscosity octenylsuccinyl starch, starch oxide starch and hydroxypropyl starch.

In one embodiment, the modified starch may be a modified starch comprising less than 50% amylose. In another embodiment, the modified starch may be a modified starch comprising less than 40% amylose. In another embodiment, the modified starch may be a modified starch comprising less than 35% amylose. In another embodiment, the modified starch may be a modified starch comprising less than 30% amylose.

The edible film composition of the present invention also includes a water soluble polymer.

In one embodiment, the water-soluble polymer is pullulan, gelatin, pectin, low viscosity pectin, hydroxypropylmethylcellulose, low viscosity hydroxypropylmethylcellulose, alginic acid, low viscosity alginic acid, sodium alginate, carrageenan, gum arabic, guar gum It may be one or more water-soluble polymers selected from the group consisting of, locust bean gum, xanthan gum, gellan gum and agar. Preferably, the water-soluble polymer may be at least one water-soluble polymer selected from the group consisting of pullulan, gelatin, pectin, low viscosity pectin, low viscosity alginic acid, hydroxypropylmethyl cellulose and low viscosity hydroxymethyl cellulose.

In the present invention, there are no limitations on the weight parts of the waxy starch hydrolyzate, modified starch and water-soluble polymer included in the edible film composition, and the weight parts of the components may be arbitrarily changed according to the use of the edible film composition. For example, when the edible film of the present invention is used as a snow-soluble preparation, it is necessary to properly adjust the weight parts of the components so that even if the content of the drug is high, the film strength is not affected. In one embodiment of the invention, the edible film composition may comprise a waxy starch hydrolyzate, modified starch and a water-soluble polymer in the ratio of 1 to 90 parts by weight: 1 to 90 parts by weight: 1 to 90 parts by weight. In another embodiment of the present invention, the edible film composition may include a waxy starch hydrolyzate, modified starch and a water-soluble polymer in a ratio of 10 to 50 parts by weight: 10 to 50 parts by weight: 10 to 70 parts by weight.

In the edible film, the waxy starch hydrolyzate, modified starch and the water-soluble polymer may be included in 40 to 99 parts by weight based on the total weight of the edible film. Preferably, the waxy starch hydrolyzate, modified starch and water-soluble polymer may be included in an amount of 50 to 95 parts by weight based on the total weight of the edible film.

Edible film compositions of the present invention may further comprise one or more additives in addition to waxy starch hydrolyzate, modified starch and water-soluble polymer.

The additive may be a filler, a plasticizer, a sweetener, an acidulant, a flavoring agent, an emulsifier, a bad breath remover, a coloring agent, a refreshing agent, and the like.

Fillers reduce the slippery properties of the film in the oral cavity and serve to impart backbone to the film. It also reduces the sticking properties of the films and can control the sticking and dissolution rates of the film in the oral cavity and the dissolution rate of the drug. The filler may be added 1 to 15 parts by weight based on the total weight of the edible film composition.

In one embodiment, the filler may be one or more components selected from the group consisting of microcrystalline cellulose, cellulose polymers, magnesium carbonate, calcium carbonate, limestone powder, silicates, clays, talc, titanium dioxide and calcium phosphate.

Plasticizers can be used to control the flexibility of the film. The plasticizer may be added in an amount of 0.1 to 15 parts by weight based on the total weight of the edible film composition.

In one embodiment, the plasticizer is at least one selected from the group consisting of sorbitol, maltitol, xylitol, glycerin, polyethylene glycol, propylene glycol, hydrogenated syrup, syrup, glycerin, triacetin, glycerol oleate, sucrose fatty acid ester, and medium chain fatty acid. It may be a component.

The edible film composition of the present invention may include a sweetener. Sweeteners may be added 1 to 10 parts by weight based on the total weight of the edible film composition.

In one embodiment, the sweetener is sugar, glucose, maltose, oligosaccharide, dextrin, invert sugar, fructose, lactose, galactose, starch syrup, sorbitol, maltitol, xylitol, erythritol, hydrogenated syrup, mannitol, trehalose, aspartame, acesulfame salt , Neotime, sucralose, taumartin, saccharin, licorice extract, stevioside, enzymatically treated stevioside, neohesperidine and monelin.

The edible film composition of the present invention may also further comprise an acidulant. The acidulant, together with the sweetener, controls the taste and may play a role in stimulating the generation of saliva so that the edible film can be dissolved well. The acidulant may be added in an amount of 0.1 to 10 parts by weight based on the total weight of the edible film composition.

In one embodiment, the acidulant may be at least one component selected from the group consisting of citric acid, malic acid, fumaric acid, tartaric acid, ascorbic acid, succinic acid, adipic acid and lactic acid.

The edible film composition of the present invention may also include perfume. Since the edible film of the present invention is a product that is dissolved and eaten in the oral cavity, it is necessary to add an appropriate flavor. The flavor may be natural flavors, artificial flavors or mixtures thereof. Natural flavors may be extracts from the leaves, flowers, fruits and the like of plants, oils of plants and the like. For example, fruit essences such as apples, peaches, grapes, strawberries, bokbunja, raspberries, cherries, plums, citron, pineapple, apricots, quince and the like can be used as natural flavorings. Plant oils include spearmint oil, cinnamon oil, peppermint oil, lemon oil, clove oil, bay oil, thyme oil, cedar leaf oil, nutmeg oil and sage ( sage) oil, almond oil, and the like. In addition, artificial flavors of fruits, such as lemons, oranges, grapes, limes, strawberries and artificial synthetic flavors such as vanilla, chocolate, coffee, cocoa, pine needles, ginseng, red ginseng, citrus may be used. The amount of the perfume used depends on a number of factors such as the type, type, and desired strength of the perfume used in general, and may generally include 1 to 15 parts by weight based on the total weight of the edible film composition.

Perfume in oil form may be used together with an emulsifier to make it compatible with water-soluble substances. The amount of the emulsifier may be adjusted according to the type and amount of the fragrance, and may generally be added in an amount of 0.1 to 10 parts by weight based on the total weight of the edible film composition.

In one embodiment, the emulsifier may be one or more components selected from the group consisting of glycerin fatty acid esters, sucrose fatty acid esters, lecithin, enzymatically treated lecithin, polysorbates, sorbitan fatty acid esters and propylene glycol.

In addition to the perfume, the edible film composition of the present invention may further include a bad breath remover to reduce oral odor. The bad breath remover can control the content thereof, and generally 0.1 to 10 parts by weight may be added to the total weight of the edible film composition. In one embodiment, the bad breath remover may be a metal salt. The metal salt may be, for example, one or more components selected from the group consisting of metal salts of chlorite, copper gluconate, zinc chloride, zinc citrate and zinc gluconate. In another embodiment, the bad breath remover is triclosan, alexidine, hextidine, benzalkonium chloride, salicylicanilide, domiphen bromide, tetradecylpyridinium chromide, N-tetradecyl-4-ethylpyridinium chloride , Octenidine, iodine, sulfonamide, bisbiguanide, phenols, delmopinol, octapinol, chlorhexitin, nisin preparation, nystatin, sangguinrin, cetylpyridinium chloride, red ginseng extract, green tea Extracts, seaweed extracts, herbal extracts, grapefruit extracts, apple extracts, thyme, thymol, antibiotics, geraniol, carbachol, citral, hinokithiol, eucalyptol, catechol, methylsalicylate and hydrogen peroxide It may be one or more components selected from the group consisting of. Such one or more bad breath remover components may be used together or independently with the one or more metal salts.

In addition, the edible film composition of this invention can contain the pigment | dye suitable for a product. The pigment may be appropriately adjusted in its content as necessary, and may generally be added in an amount of 0.01 to 10 parts by weight based on the total weight of the edible film composition. The pigment may be a natural or synthetic pigment.

The edible film composition of the present invention may also further comprise a freshener. The coolant may be, for example, but not limited to, WS3, WS23 or Questais-L. The freshener may be suitably adjusted in amount as necessary and may generally be added in an amount of 0.01 to 5 parts by weight based on the total weight of the edible film composition.

The edible film of the present invention can be used not only as an oral cleaning agent and a bad breath removing agent, but also as a snow-soluble agent.

The present invention therefore also provides a snow-soluble preparation comprising a waxy starch digest, a modified starch, a water soluble polymer and a pharmaceutically active ingredient.

Pharmaceutically active ingredients include, but are not limited to, antidiabetic agents such as, for example, glymepiride, pioglitazone, and the like; Agents for treating insomnia such as zolpidem, eszopiclone and the like; Urogenital therapeutics such as tolterodine, tropium and the like; Anti-obesity agents such as sibutramine and the like; Enzymes such as streptokinase and the like; Peptic ulcer solvents such as omeprazole; Antitussive expectorants, such as clebuterol hydrochloride; Skin disease treatment agents such as finasteride and the like; Antiemetic agents such as ondansetron; Antidepressants such as fluoxetine and the like; Antihistamines such as fexofenadine hydrochloride; Antipyretic analgesic agents such as aspirin, ibuprofen, meloxycam and the like; Hormonal agents such as testosterone and the like; Therapeutic agents for circulatory organs such as felodipine, atorvastatin, ammodidicamramic acid, doxazosin, simvastatin, lercanidipine and the like; Therapeutic agents for the digestive system such as pamotidine, lansoprazole, and the like; Psychonetics such as paroxetine, and the like; Erectile dysfunction agents such as sildenafil, tadalafil, and the like; Osteoporosis therapeutics; Arthritis agents; Epilepsy treatments; Muscle relaxants; Brain function improvers; Schizophrenic agents; Immunosuppressants; Antibiotic; Anticancer agent; Anticancer adjuvant; Vaccines; Mouthwashes; Anemia treatment agents; Constipation therapy; vitamin; Nutrients; Lactic acid bacteria; Comprehensive cold medicine; Or health functional foods.

The kind of pharmaceutically active ingredient which can use the edible film of this invention as a drug delivery system is not limited. Any drug that can be administered orally through the mouth can be used. For example, the pharmaceutically active ingredient is triclosan, cetyl pyridium chloride, domiphen bromide, quaternary ammonium salt, zinc compound, acid guinarin, fluoride, alexidine, octonidine, EDTA, aspirin, acetaminophen, ibuprofen, keto Propene, Diflunisal, Phenopropene Calcium, Naproxen, Tolmetin Sodium, Indomethacin, Benzonatate, Caramiphene, Edsylate, Menthol, Dextromeropane, Hydrobromide, Hydrochloride, Crofedianol , Diphenhydramine, pseudoephedrine, phenylephrine, phenylpropanolamine, pseudoephedrine sulfate, brompheniramine maleate, chlorpheniramine maleate, carbinoxamine maleate, clemastine fumarate, dexchlorpheniramine Latex, diphenhydramine hydrochloride, diphenhydramine citrate, diphenylpyralinehydrochloride, doxylamine succinate, fr Metazin hydrochloride, pyrylamine maleate, tripyleneamine citrate, triprolidine hydrochloride, acribastine, loratadine, bromfenyramine, dexbromfenyramine, guapefensin, ifepac, calcium Iodide, terpinhydrate, loperamide, pamotidine, ranitidine, omeprazole, lansoprazole, aliphatic alcohol, nicotine, caffeine, strikinin, picrotoxin, pentylenetetrazole, phenyhydantoin, phenobarbital, primidone , Carbamezepine, etosuccimid, metsuccimid, pensuccimid, trimmethadione, diazepam, benzodiazepines, phenacemid, phenturide, acetazolamidesultiam, bromidevodopa, amantadine, morphine, heroin, hydro Mortin, methopone, oxymorphone, levorpanone, codeine, hydrocondon, gycodone, nalnorphine, naloxone, naltrexone, salicylate. Phenylbutyrate, indomethacin, phenacetin, chlorpromazine, methotreeprazine, haloperidon, clozapine, reserpin, imiprazine, tranilcif, lomine, phenelzin, iridium, apomorphine, sildenafil, One selected from the group consisting of tadanafil, vardenafil, zolpidem tartrate, bambuterine hydrochloride, galantamine chloride, galcarmine dipine, paroxetine hydrochloride, meloxycamp, tolteridine tartarate and doxazosin mesylate The above components may be used.

The present invention also provides an edible film comprising the above edible film composition.

The edible film of the present invention will preferably form a thin film that maintains an appropriate range of tensile strength and toughness in a very thin film state. In one embodiment, the thickness of the edible film of the present invention is 20 μm to 100 μm, preferably 40 μm to 60 μm. If the thickness exceeds 100㎛, the sensory slipperiness increases, so it can be slightly compensated by adjusting the addition amount of sweetener, acidulant, gelling agent, filler, fragrance, etc.However, if too thick, melting time increases and overcomes sensory slippery Not easy to do

The present invention also provides a method for producing an edible film.

In one embodiment, the method of making an edible film of the present invention

(1) preparing an edible film composition comprising a waxy starch hydrolyzate, modified starch and a water soluble polymer;

(2) putting the edible film composition into a molding machine to mold the film at 50 to 80 ° C;

(3) may comprise aging the molded film at a relative humidity of 50 to 70% for 1 to 10 days.

Method for producing an edible film according to the present invention can be carried out through the following process, for example.

(1) crude liquid process

a) First solution manufacturing process: Wax starch hydrolyzate and modified starch water-soluble polymer are added to boiling water and dissolved completely.

b) 2nd solution manufacturing process: The 2nd solution which mixed additives, such as a pigment, a sweetener, an acidulant, and a filler, is prepared.

c) Third solution manufacturing process: A third solution is prepared by mixing menthol, perfume and freshener with an emulsifier.

d) 4th solution manufacturing process: The 4th solution is prepared by mixing the said 2nd solution and the said 3rd solution.

e) 5th solution manufacturing process: It raises the temperature to 60 degreeC or more, and mixes the said 1st solution and the said 4th solution, and manufactures a 5th solution.

(2) forming process

The fifth solution is filtered and then introduced into a molding machine to form a film. At this time, the temperature of the molding machine is 50 to 80 ℃ and manufactured in roll form through a belt drum dryer.

(3) Aging process

The molded film contains moisture suitable for slitting or cutting through a aging process of about 1 to 10 days at a relative humidity of 50 to 70%. The moisture content at this time is 10 to 14% is appropriate.

The following process may be further performed as a subsequent process of the manufacturing method.

(4) cutting process

The aged rolls are slit into small rolls, cut into appropriate sizes and filled into small containers.

(5) Packing process

Products in filled, small containers are labeled and repacked on film or put into blisters for production.

EXAMPLE

Experimental Example 1: Evaluation of film forming power, quality and solubility according to the type of starch

In order to confirm the superiority of the waxy starch hydrolyzate, high amylose corn starch (A), corn starch (B), waxy corn starch (C), waxy corn starch hydrolyzate (D) by varying the type of starch Table 1 An edible film was prepared with the composition of, and the film forming power, taste, and solubility were evaluated.

As modified starch, starch oxide, starch oxide starch, hydroxypropyl corn starch (HP starch), and low viscosity octenylsuccinyl starch (low viscosity OS starch) were used.

As the high amylose corn starch (A), Amylogel 03001 of cargill (cargill), corn starch (B), waxy corn starch (C) and waxy corn starch hydrolyzate (D), the target corn starch Subjected corn starch and BTR waxed starch were used respectively. The low viscosity OS starch was used by reacting OS starch (trade name: HITEX) obtained from the company with 1N hydrochloric acid for 1 hour to lower the viscosity.

HP starch was used by low viscosity by reacting Kreation D8 obtained from Avebe with 1N hydrochloric acid for 1 hour. The starch oxide acetate was used by reacting the oxidized starch of the object with acetic anhydride. At this time, the degree of acetyl group substitution was 3% (containing three acetyl groups per 100 molecules of glucose). The low viscosity HPMC used Demacol HE 5/6 BV. Low viscosity pectin was used with GENU Pectin DSS from CP kelco. Low viscosity alginic acid used MSC login. Gelatin used Geltech's 100Bloom product, and pullulan used Shanghai Biotechnology Co., Ltd.'s product.

[Table 1] Film forming power, microcrystalline and solubility according to the type of starch

Compounding cost Starch Starch content (%) Modified starch Modified starch content (%) Water soluble polymer Water Soluble Polymer Content (%) Film formation Taste Solubility (seconds) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 A B C D A B C D A B C D A B C D A B C D 10 8 15 25 10 8 15 25 10 8 15 25 10 8 15 25 10 8 15 25 Oxygen Starch Oxygen Starch Oxygen Starch Oxygen Starch Oxygen Starch HP Starch HP Starch HP Starch HP Starch Low Viscosity OS Starch Low Viscosity OS Starch Low Viscosity OS Starch Low Viscosity OS Starch HP Starch HP Starch HP Starch HP Starch Starch oxide 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 Low Viscosity Alginic Acid Low Viscosity Alginate Low Viscosity Alginic Acid Low Viscosity Alginate Low Viscosity Pectin Low Viscosity Pectin Low Viscosity Pectin Low Viscosity Pectin Gelatin Gelatin Gelatin Gelatin Pullulan Pullulan Pullulan Pullulan Low Viscosity HPMC Low Viscosity HPMC Low Viscosity HPMC 15 15 15 15 13 13 13 13 25 25 25 25 22 22 22 22 20 20 20 20 Medium Heavy Load Medium Heavy Load Medium Load Heavy load Heavy load Heavy load Heavy load 21 16 11 10 19 14 10 10 16 13 8 7 16 12 8 7 25 16 11 10

* Starch, modified starch, water-soluble polymer content is the added solids content of the total solids (wt / wt).

As can be seen from Table 1, the use of waxy starch hydrolysates with modified starch and water-soluble polymers is superior in terms of film formation, microporousity and solubility compared to those of high amylose starch, ordinary starch and waxy starch. Results are shown.

Preparation Example 1

According to the following method was added in the component ratio of Table 2 to prepare an edible film.

(1) Water was heated to 90 ° C. or higher, and waxy starch hydrolyzate, hydroxypropyl starch and pectin were added to prepare a 10% solution. The temperature of the stock solution was cooled to 70 ° C.

(2) a pigment, a high sweetener, citric acid, and microcrystalline cellulose were mixed into the one-step solution to prepare a two-step solution.

(3) A menthol, a perfume and an emulsifier were dissolved in water at 60 ° C. and then emulsified to prepare a three-step solution.

(4) a 4-step solution was prepared by mixing the 2-step solution and the 3-step solution. The 4 step solution was filtered and then put into a molding machine to form a film, and aged for 7 days at 60% relative humidity. The product was packaged in a container after slitting and cutting.

TABLE 2
Component (unit: parts by weight) Preparation Example 1 Comparative Production Example 1 Comparative Production Example 2 Comparative Production Example 3 Waxy Starch Hydrolyzate High Amylose Corn Starch Corn Starch Wax Corn Starch Hydroxypropyl Starch Pectin Microcrystalline Cellulose Sucralose Aspartame Licorice Extract Citric Acid Menthol Coffee Flavor Polysorbate Glycerin WS-3 Blue No. 1 Eucalyptol 36.8---29.4 7.4 7.5 1.5 1.5 1.5 0.9 5.1 5.7 0.9 0.9 0.7 0.1 0.1 -18.9--37.7 9.4 9.6 1.9 1.9 1.9 1.1 6.6 7.4 1.1 1.1 0.9 0.2 0.2 --15.7-39.2 9.8 10.0 2.0 2.0 2.0 1.2 6.9 7.6 1.2 1.2 1.0 0.2 0.2 ---25.9 34.5 8.6 8.8 1.7 1.7 1.7 1.0 6.0 6.7 1.0 1.0 0.9 0.2 0.2
* Calculation calculated by assuming 10% moisture after film production

delete

delete

Comparative Production Example 1

The same procedure as in Preparation Example 1 was conducted except that high amylose starch was added instead of waxy starch hydrolysate.

Comparative Production Example 2

Corn starch was added instead of waxy starch hydrolyzate.

Comparative Production Example 3

The same process as in Preparation Example 1 was conducted except that waxy starch was added instead of waxy starch hydrolysate.

Experimental Example 2:

The film forming power, film solubility and functional slipperiness of the edible films of Production Example 1 and Comparative Production Examples 1 to 3 were evaluated. The film forming power was good in the order of Comparative Production Example 1> Comparative Production Example 2> Comparative Production Example 3 = Preparation Example 1, and the solubility and the sensory slipperiness of the film were in Preparation Example 1> Comparative Production Example 3> Comparative Production Example 2> Comparative Production Example 1 was good in order.

Preparation Examples 2 to 5

Unlike hydroxypropyl starch as the modified starch in Preparation Example 1, an edible film was prepared according to the composition of Table 3 using starch oxide acetate, starch oxide, and octenylsuccinyl sodium starch as modified starch.

Starch oxide, starch oxide, octenyl succinyl sodium starch was not significantly different in film forming ability, film solubility, and functional slippery except for ease of use.

TABLE 3
Component (unit: parts by weight) Preparation Example 2 Preparation Example 3 Preparation Example 4 Preparation Example 5 Waxy Starch Hydrolyzate Hydroxypropyl Starch Oxide Acetic Acid Starch Oxide Starch Octenylsuccinyl Sodium Starch Pectin Microcrystalline Cellulose Sucralose Aspartame Licorice Extract Citric Acid Menthol Lemon Flavor Polysorbate Glycerin WS-3 Yellow No. 4 34.2 27.4---13.7 7.0 1.4 1.4 1.4 0.8 5.0 5.3 0.8 0.8 0.7 0.1 34.2-27.4--13.7 7.0 1.4 1.4 1.4 0.8 5.0 5.3 0.8 0.8 0.7 0.1 34.2--27.4-13.7 7.0 1.4 1.4 1.4 0.8 5.0 5.3 0.8 0.8 0.7 0.1 34.2---27.4 13.7 7.0 1.4 1.4 1.4 0.8 5.0 5.3 0.8 0.8 0.7 0.1
* Calculation calculated by assuming 10% moisture after film production

delete

delete

Preparation Example 6 to Preparation Example 9

The food film was prepared using gelatin, pullulan, and hydroxypropyl methyl cellulose instead of pectin as the water-soluble polymer in the mixing ratio of Table 4.

TABLE 4
Component (unit: parts by weight) Preparation Example 6 Preparation Example 7 Preparation Example 8 Preparation Example 9 Wax Starch Hydrolyzate Hydroxypropyl Starch Oxidized Starch Pectin Gelatin Pullulan Hydroxypropylmethylcellulose Microcrystalline Cellulose Sucralose Aspartame Licorice Extract Citric Acid Menthol Grape Scent Polysorbate Glycerin WS-3 Cochinyl Extract Pigment Eucalyptol 33.3 26.7-16.0---6.8 1.3 1.3 1.3 0.8 4.7 5.2 0.8 0.8 0.7 0.1 0.1 28.4 22.7--28.4--5.8 1.1 1.1 1.1 0.7 4.0 4.4 0.7 0.7 0.6 0.1 0.1 29.4-23.5--25.9-6.0 1.2 1.2 1.2 0.7 4.1 4.6 0.7 0.7 0.6 0.1 0.1 28.4-22.7---28.4 5.8 1.1 1.1 1.1 0.7 4.0 4.4 0.7 0.7 0.6 0.1 0.1
* Calculation calculated by assuming 10% moisture after film production

delete

delete

As a result of evaluating film forming power, film solubility and functional slipperiness, film forming power was good in the order of gelatin> pullulan> hydroxymethyl cellulose> pectin. The solubility and the sensory slipperiness of the film were good in the order of gelatin> pullulan> hydroxypropylmethylcellulose> pectin.

Preparation Example 10 to Preparation Example 14

The film was prepared according to the composition of Table 5 by adding pharmaceutically active ingredients including melatonin and zolpidem tartrate.

TABLE 5
Component (parts by weight) Preparation Example 10 Preparation Example 11 Preparation Example 12 Preparation Example 13 Preparation Example 14 Wax Starch Hydrolyzate Hydroxypropyl Starch Oxidized Starch Hydroxypropylmethylcellulose Gelatin Pullulan Microcrystalline Cellulose Sucralose Aspartame Licorice Extract Citric Acid Menthol Strawberry Flavor Polysorbate Glycerin WS-3 Blue No. 1 Melatonin zolpidem tartarate galantamine Chlorinated Tadalafil Vardenafil 25.0 20.0-22.0-- 5.2 1.0 1.0 1.0 0.6 3.5 3.9 0.6 0.6 0.5 0.1 15.0---- 22.1 17.7--19.4-4.6 0.9 0.9 0.9 0.5 3.1 3.4 0.5 0.5 0.4 0.1-25.0--- 25.6-20.6--22.7 5.3 1.0 1.0 1.0 0.6 3.6 4.0 0.6 0.6 0.5 0.1--12.8-- 25.7-20.7-22.7-5.4 1.0 1.0 1.0 0.6 3.6 4.0 0.6 0.6 0.5 0.1---12.5- 27.5-21.9 24.3--5.7 1.1 1.1 1.1 0.7 3.9 4.3 0.7 0.7 0.6 0.1----6.3
* Calculation calculated by assuming 10% moisture after film production

delete

delete

As a result of evaluating film forming power, film solubility and sensory slipperiness, there was no big problem when the dose of the medicinal active ingredient was less than 20%, but when the 30% or more was added, the film forming power and the strength decreased.

Claims (3)

A waxy starch hydrolyzate having a viscosity of 500-5000 cps at 40 ° C. as a hydrolyzate of waxy starch having an amylopectin content of at least 90% by weight; At least one modified starch selected from the group consisting of starch oxide, octenylsuccinyl sodium starch, octenylsuccinyl sodium starch, starch oxide starch and hydroxypropyl starch having an amylose content of less than 30% by weight; Water-soluble polymers which are gelatin, pullulan or mixtures thereof; And Contains a pharmaceutically active ingredient, 10 to 50 parts by weight of the waxy starch hydrolyzate, 10 to 50 parts by weight of modified starch and 10 to 70 parts by weight of water-soluble polymer, characterized in that Snow soluble preparations. The method of claim 1, The pharmaceutical active ingredient may be used for treating diabetes; Insomnia therapy; Urogenital therapy; Obesity treatment; Enzymes; Peptic ulcer solvents; Antitussive expectorants; Skin disease treatments; Antiemetic agent; Antidepressants; Antihistamines; Antipyretic analgesic agents; Hormonal preparations; Circulatory therapy; Treatments for the digestive system; Mental neurological agents; Erectile dysfunction treatment; Osteoporosis therapeutics; Arthritis agents; Epilepsy treatments; Muscle relaxants; Brain function improvers; Schizophrenic agents; Immunosuppressants; Antibiotic; Anticancer agent; Anticancer adjuvant; Vaccines; Mouthwashes; Anemia treatment agents; Constipation therapy; vitamin; Nutrients; Lactic acid bacteria; Comprehensive cold medicine; Or one or more ingredients selected from the group consisting of dietary supplements. The method of claim 1, The active ingredient is triclosan, cetyl pyridium chloride, domiphen bromide, quaternary ammonium salt, zinc compound, acid guinarin, fluoride, alexidine, octonidine, EDTA, aspirin, acetaminophen, ibuprofen, ketoprofen, dif Rooneysal, Phenopropenecalcium, Naproxen, Tolmethinine Sodium, Indomethacin, Benzonatate, Caramiphene, Edicillate, Menthol, Dextromerophane, Hydrobromide, Hydrochloride, Cropedinool, Diphenhydramine , Pseudoephedrine, phenylephrine, phenylpropanolamine, pseudoephedrine sulfate, brompheniramine maleate, chlorpheniramine maleate, carbinoxamine maleate, clemastine fumarate, dexchlorpheniramine maleate, diphenhydra Minhydrochloride, Diphenhydramine Citrate, Diphenylpyrroline Hydrochloride, Doxylamine Succinate, Promethazine Drochloride, Pyrylamine Maleate, Tripelinamine Citrate, Triprolidine Hydrochloride, Acribastine, Loratadine, Bromfeniramine, Dexbromfenyramine, Guapefensin, Ifecac, Calcium Iodide , Terpinhydrate, loperamide, pamotidine, ranitidine, omeprazole, lansoprazole, aliphatic alcohol, nicotine, caffeine, strikinin, picrotoxin, pentylenetetrazole, phenyhydrantoin, phenobarbital, primidone, carr Bamzepine, Etosuccimid, Metsuccimid, Pensuccimid, Trimmethadione, Diazepam, Benzodiazepines, Penacemide, Peneturide, Acetazolamide Sultiam, Bromydredodopa, Amantadine, Morphine, Heroin, Hydromortin , Methopone, oxymorphone, levorpanone, codeine, hydrocondon, gycodone, nalnorphine, naloxone, naltrexone, salicylate. Phenylbutyrate, indomethacin, phenacetin, chlorpromazine, methotreeprazine, haloperidon, clozapine, reserpin, imiprazine, tranilcif, lomine, phenelzin, iridium, apomorphine, sildenafil, One selected from the group consisting of tadanafil, vardenafil, zolpidem tartrate, bambuterine hydrochloride, galantamine chloride, galcarmine dipine, paroxetine hydrochloride, meloxycamp, tolteridine tartarate and doxazosin mesylate Snow soluble preparation which is the above component.