KR20180015437A - Composition for Tableting Comprising Natural Excipient - Google Patents

Abstract

The present invention relates to a composition for tableting using a natural excipient. More specifically, by using the composition of the present invention in the preparation of tablets, tablets with excellent qualities composed of chicory fibers, whole milk powder, yeast, and a kelp extract as a natural excipient can be provided. Water and alcohol granules may be further added to improve flowability. Conventionally, the formulation of a tableting preparation uses chemical substances as a main component, but since the present invention uses a natural raw material, an environmentally friendly composition for tableting can be provided.

Description

Composition for Tableting Comprising Natural Excipient Containing Natural Excipients [

The present invention relates to a tableting composition comprising a natural excipient. More specifically, it is composed of natural chicory fiber, whole milk powder, yeast and seaweed extract as an excipient in the production of tablets.

Conventionally, the chemical formulation is used as a main component in the formulation of the tablet formulation, but since the present invention uses a natural raw material, it is possible to provide an environmentally friendly composition for tablet formulation.

Tablets are prepared by mixing tablets with excipients and compressing tablets with tablets to prepare tablets of a certain type. For the purpose of binding agents, lubricants, disintegrants, and release agents, lactose, celluloses, starches, inorganic salts, sugar alcohols Etc. are used in the tabletting process.

Excipients are used in pharmaceuticals and foodstuffs for the mixing of excipients and active ingredients, liquidity, tableting and hardness during tablet preparation, rapid disintegrability, sticking of the tablet punches, , Capping and laminating where the tablets are peeled off, and the like.

Binders are water, glycerol, gum arabic, tragacanth, saccharides, glycerol, rubber, etc. in order to bind the medicine or food of the powder with tablets to give elasticity and tackiness.

The lubricant is added to prevent the adhesion of the granules during the granulation of the pharmaceutical and to improve the gloss of the tablets, and includes purified talc stearic acid and its salts, boric acid powder, liquid paraffin, sodium benzoate, carbo wax, polyethylene glycol and hydrogenated vegetable oil.

Disintegrants include starches, carbonates, etc. in which tablets, capsules and the like are added to promote disintegration in digestive juices.

Korean Patent Registration No. 10-0661782 (a tablet having improved tabletting properties and a method for producing the above-described water) is intended to provide a tablets having good usability and excellent tabletting, abrasion resistance, and mechanical strength in the prior art related to the present invention . (3) a quantity of water that is at least equal to the moisture content at 12% humidity, equilibrated at 25 DEG C; and (3) a powder or granular mixture comprising (1) an effective amount of a pharmacologically active substance; and And a tableting agent having an average particle size of 100 mu m or less is compounded in a ratio of 1 to 50 wt% based on the mixture, and then the resultant mixture is kneaded.

Korean Patent Laid-Open No. 10-2011-0063549 relates to a process for producing granules containing as a main component a tableting aid for lactose and cellulose main components, granules obtained by the process and their use as excipients for tableting. Korean Patent Registration No. 10-0713138 discloses a chewing gum composition comprising a chewing gum base and a mixture in which the chewing gum composition is excluded from the chewing gum composition by granulating in a separate process, Which is a process for producing tablet gum. Korean Patent Laid-Open Publication No. 10-2015-0068490 discloses a tableting nutritional supplement composition comprising a matrix having a tableting filler liquid lubricant wherein the matrix with filler lubricant comprises an oily liquid finely dispersed in the oil insoluble material, Wherein the composition is substantially free of stearate.

Korean Patent Registration 10-0661782

Recently, there has been an increasing number of cases in which medicines, foods, or functional foods are provided as tablets or capsules to suit the convenience of the user to carry and diet. However, excipients such as magnesium stearate, cellulose derivatives, starch, lactose, dicalcium phosphate, sorbitol, polyvinylpyrrolidone, and polyethylene glycol are widely used. Moreover, while the amount of drug used in these tablets is very small, most of the excipients used in large quantities are chemical substances and do not deserve a natural excipient to replace them. Accordingly, the tablets are being miniaturized so as to be easy to take, and there is a tendency to prefer a natural-oriented binder which can reduce the volume of the binder which occupies a large volume among the excipients and increase the hardness of the tablets.

The fluidity and the volatility generated when the main component and the excipient are mixed in the manufacturing process of the tablet are important. There should be no obstacle to fixation such as sticking, capping, laminating, etc. where powder adheres to the surface of tablet punch and the surface of tablet is scratched. Tablets that are tableted should also meet the appropriate hardness and fast disintegration time, and should be free of low abrasion to the external impact of the tablet and no change in properties during storage. Generally, when a water-soluble polymer is contained in a tablet, it is known that when the tablet is collapsed with saliva or water in the oral cavity, the water-soluble polymer is dissolved to thereby manifest viscosity and the penetration of water into the tablet is inhibited, It is pointed out as a disadvantage.

The present invention consists of natural powdered milk and yeast as an excipient in the production of tablets, and further contains a chicory fiber and a seaweed extract to reinforce the binding force. In addition, granulation processes with water and alcohol may be included to improve fluidity.

The chicory fiber acts as a binder and excipient, the powdered milk acts as a glidant and disintegrant, and the yeast is used as an excipient. Seaweed extracts are also used to control the binding force. In addition, water and alcohol can be used to improve the fluidity of granular raw materials to improve fluidity.

Accordingly, the present invention aims at solving the problems that arise in tabletting while using natural raw materials as excipients.

Chicory is a perennial plant of Asteraceae. It is an alkaline food rich in dietary fiber. Its roots are slightly cooked and eaten with butter. Leaves are eaten as a salad. Leaves are grown in the spring. Plants are used as feed or grass. Flowers are used as a stimulant for the central nervous system and as a drug to enhance cardiac activity. Fiber, which is dried and crushed by chicory, is effective for diet because of low calories. It is good for preventing constipation because it is rich in carotene, vitamin B2 and vitamin C as well as potassium, iron, and dietary fiber. Ingredients promote intestinal digestion, It lowers the absorption of cholesterol, which is good for beauty, prevention of adult diseases and diabetes. In addition, the inulin of chicory improves the intestinal flora and reduces the absorption of cholesterol in the intestines by eliminating 50% of the cholesterol in the stomach, thereby lowering the total cholesterol content in the liver and blood, reducing the glucose uptake and preventing diabetes . The chicory fiber was 700 μm in size (made in Belgium).

Whole milk powder was prepared by homogenizing crude oil (3000 psi), sterilizing it at 90 ° C for 3 minutes, pre-heating it at 71 ° C, spray drying it by high-pressure pump (2500psi) 2 to 4%. Cool the particles and seal them. Due to its high fat content, it is easy to oxidize and is stored at room temperature for 3 to 7 months. It is used as a raw material for confectionery, baking, and ice cream. When water is poured, it is reduced to milk and is used as a reducing euro. It is rich in nutrients such as protein, milk fat, carbohydrate, etc., with calories of 495kcal, carbohydrate of 38g, fat of 27g, protein of 25g, calcium of 950mg and sodium of 420mg per 100g of whole milk powder. Whole milk powder was purchased from a domestic company (Seoul Milk) and used.

Yeast is a single-celled organism composed of a single cell of 3-4 μm in size. It is able to obtain energy by decomposing the saccharide saccharide without oxygen supply. It grows at 10 ° C. to 37 ° C. and reproduces by germination. Pyruvic acid is decomposed in the inorganic respiration process to release alcohol and carbon dioxide. In the organic breathing process, only water and carbon dioxide are released, which is used for the fermentation of bread and beer. In addition, yeast cells contain vitamin B and D as well as fat and protein, so they are also used in feeds and medicines. In particular, brewer's yeast activates Bifidobacterium bacterium, which is beneficial to the intestinal tract, and is effective for constipation. The rich vitamins B and D and various minerals are effective in anti-aging, fatigue recovery, hair loss prevention, skin beauty, and removal of waste products and toxins. In addition, the brewer's yeast activates bifidobacteria, which are beneficial bacteria in the intestines, and is effective for constipation. The yeast was selected from among yeast (selected from domestic, Lithuanian, or Mexican) pulverized to a size of 50 to 70 mesh.

Kelp contains carotenoids such as mannit and laminarin, which are formed as a result of carbon assimilation (carbon assimilation), as well as various pigments such as carotenes, xanthophylls and chlorophyll, and alginic acid, which is a component of the cell wall And contains amino acids such as iodine, vitamin B2 and glutamic acid. These ingredients are 16% moisture, 7% protein, 1.5% fat, 49% carbohydrates, and 26.5% inorganic salts. 20% of carbohydrates are cellulose and the rest are polysaccharides such as alginate and laminarin. In particular, it contains a large amount of inorganic salts such as iodine, potassium, and calcium, and kelp greatly contributes to constipation. Alginic acid is abundant to prevent absorption of fat to help dieting, prevention of arteriosclerosis and hypertension, and cholesterol .

Seaweed extract (extraxt) is a concentrate obtained by hot water extraction from sea tangle. Korean sea tangle (karaku) was purchased with a size of 40 mesh or more.

Ethanol is produced by the fermentation of sugar by yeast. The major components are ethyl alcohol (15-16%), wine (7-14%), beer (3-4%), distilled spirits Contains ethanol of brandy (35-55%). Ethanol has strong sterilizing power, has low toxicity and has washing power, so it is used for disinfection of hands and skin. It is used for precipitation in the separation of DNA with non-polar solvent. It is used as surface disinfectant in tissue culture. It can also be used as an analytical reagent in addition to industrial solvents, synthetic raw materials, medicinal tincture, and main tablet. Ethanol (Shinyoung product) was used. In addition, as a natural excipient, calcium carbonate powder, Lacto Iron, Lacto Vitamin B6, Lacto B9 folic acid, MNY dry yeast, dried yeast zinc, dried yeast vitamin D, dried yeast manganese, dried yeast molybdenum, dried yeast vitamin B1, , Dried yeast selenium, rice extract powdered magnesium glucan, powdery mushroom powder, aloe whole leaf, spirulina and dry yeast biotin.

The present invention is a natural raw material which exhibits good tableting properties at low pressure, high hardness of tablets, low wear and tear, and fast disintegration. Therefore, it is possible to obtain better physical properties than the conventional chemical excipients and to improve the workability.

1 shows a manufacturing process diagram of the present invention.

The present invention can provide tablets having excellent qualities composed of chicory fiber, whole milk powder, yeast, seaweed extract, acerola extract powder, iron powder derived from lactic acid bacteria, and zinc-containing dry yeast as natural excipients in the production of tablets. Water and alcohol may also be included for fluidity.

The tableting composition for oral administration of the present invention may further include carbohydrates, minerals, vitamins, functional substances and nutrients in natural products.

The processing aid may be selected from the group consisting of absorbents, diluents, fragrances, colorants, stabilizers, fillers, binders, disintegrants, lubricants, anti-adsorbents, sugar or film coatings, preservatives, buffers, artificial sweeteners, natural sweeteners, dispersants, thickeners, Some combinations include, but are not limited to.

Specifically, the carbohydrate may be selected from, but not limited to, starch, dextrin, sugar, glucose, maltose, fructose, sorbitol, sucrose, mannitol, sorbitol, lactose and maltodextrin.

Minerals include but are not limited to iron, iodine, magnesium, zinc, selenium, copper, calcium, manganese, silicon, molybdenum, vanadium, boron, nickel, tin, phosphorus, chromium, cobalt, It is not.

The functional material may be selected from, but not limited to, carotenoids, phytosterols, polyphenols, choline, isocitol, omega-3 fatty acids, probiotics and glucosamine.

Vitamins are vitamins such as vitamin C, vitamin E, thiamine (vitamin B1), riboflavin (vitamin B2), niacin (vitamin B3), pyridoxine (vitamin B6), folic acid, cobalamin (vitamin B12), pantothenic acid (And vitamin A precursors), vitamin D, vitamin K, and other B-complex vitamins, and mixtures thereof.

Nutrients include, but are not limited to, organic acids, amino acids, peptides, and mixtures thereof.

Lacto Vitamin B6 [B6 20%] by InterCell, Lacto B9 [Folic Acid 1%] by InterCell Co., Ltd .; and other natural excipients such as seaweed calcium powder (calcium 32% Dried yeast [manufactured by LALMIN, manufactured by LALMIN, dried yeast [0.2% of molybdenum], manufactured by LALMIN, manufactured by LALMIN Co., Manufactured by InterCell, manufactured by InterCell [11% of vitamin B2] manufactured by InterCell, dried yeast (0.2% of selenium) manufactured by PHARMACHEM LABORATORIES.INC, rice extract powder (magnesium 16%) manufactured by LALMIN Co., One or two or more selected from the group consisting of imported indigenous rice, aloe vermicelli imported from Mexico, imported from Spirulina Taiwan, dried yeast [biotin 0.45%], InterCell, etc. can be used.

≪ Example 1-4 >

10 to 40 parts by weight of whole powdered milk, 25 to 60 parts by weight of chicory fiber, 4 to 50 parts by weight of yeast powder, 5 to 10 parts by weight of seaweed extract, 7 to 10% by weight of extracted acerola (natural vitamin C) 15 to 18 parts by weight of iron-derived lactic acid bacteria, 13 to 18 parts by weight of zinc-containing dry yeast, and 10 to 50% by weight of purified water or ethanol are mixed with a super mixer and then mixed with a food such as a plate- Or as a health functional food. The formulations of the pharmaceutical preparations can be made into a variety of granules, pellets, tablets, capsules, powders and the like according to known methods, but the detailed description thereof will be omitted.

In fluidized bed granulation, a mixture of powdered milk or a pharmaceutically acceptable food or pharmaceutical excipient, a mixture of yeast powder and sea tangle extract is put into a fluidized bed granule container, and the temperature of the air sucked is adjusted to 60 to 70 ° C Drying granules can be obtained by spraying a solution of chicory fiber while warming. Other methods can be used such as a general super mixer assembly process or a granulation process using a ribbon type mixer.

10 to 40% by weight of whole milk powder, 30 to 60% by weight of chicory fiber, 3 to 80% by weight of yeast powder, 5 to 20% by weight of seaweed extract, 10 to 50% by weight of purified water or ethanol The mixture was mixed with the mixing ratios of Examples 1-4 and the control group, and the resulting mixture was tableted using a rotary tablet machine with an average tablet weight of 530 ± 30 milligrams and an average hardness of 10 ± 3 kg.

 Compounding ratio (unit: parts by weight) division Natural excipient Control group additive Example 1 Example 2 Example 3 Example 4 additive Addition amount Whole milk powder 30 25 18 18 Lactose 10 Chicory fiber 57.7222 59 58 25 glucose 88.5 Yeast powder 4.1128 0 5 40 Stearic acid Mg One Seaweed extract 0 0 5 0 SiO ₂ 0.5 Other 8.165 16 14 17 Other 0 system 100 100 100 100 system 100 Purified water Suitable amount Suitable amount Suitable amount Suitable amount Suitable amount Suitable amount spirits Suitable amount Suitable amount Suitable amount Suitable amount Suitable amount Suitable amount

* The above purified water and alcohol are not included in the total since they are evaporated during manufacture.

The above-mentioned guitar is the same as the embodiment 1; Acerola extract powder (natural vitamin C), Example 2; Iron-derived iron powder, Example 3 and Example 4; Zinc-containing dry yeast.

Table 2 shows the results of observing and measuring the disintegration time, the degree of abrasion, and the sticking of the tablets prepared as described above by a known method.

Test result of puncture division Example 1 Example 2 Example 3 Example 4 Control group Hardness (kp) 7 7 8 8 8 Disintegration time (minutes) - 16 15 14 15 Attachment none none none none Has a little Marson (%) 0.01 or less 0.01 or less 0.01 or less 0.01 or less 0.01 or less

* The chewable formulation of Example 1 was not tested separately because there was no disintegration in the test items in the Health Functional Food Act.

It can be seen from the results of the tableting test of the composition for tableting using the natural excipient of the present invention and the composition using the non-natural excipient as a control group that the composition of the present invention is excellent.

<Examples 5-10>

1 g of vitamin C (ascorbic acid) in health functional foods, 2 g of methylsulfonylmethane as an osteoarthritis protection agent, 1.5 g of glucosamine as an arthritis preventing agent, and 100 mg of hyaluronic acid as a skin- 1 to 4 and the preparation method, respectively, and the resulting mixture was compressed into tablets using a rotary tablet press with an average tablet weight of 530 ± 30 milligrams and an average hardness of 10 ± 3 kg.

Food, medicines, health functional food combination ratio (parts by weight) division/
additive Example 5 Example 7 Example 8 Example 10 Vitamin C
Ascorbic acid Dietary sulfur
MSM For joints
Glucosamine For skin
Hyaluronic acid Whole milk powder 18 18 18 18 Chicory minutes 57 56 56.5 57.9 Yeast powder 5 5 5 5 Seaweed powder 5 5 5 5 Natural iron 14 14 14 14 The component One 2 1.5 0.1 system 100 100 100 100

These components represent vitamin C (ascorbic acid) in health functional foods, dietary sulfur in osteoarthropathic preparations, glucosamine in anti-arthritic drugs, and hyaluronic acid content in skin-beauty agents.

The excipient of the present invention is a natural raw material which has good stability at low pressure, high hardness of tablets at the time of tableting, low degree of abrasion / abrasion and fast disintegration, and thus has better physical properties and improved workability than conventional chemical excipients, There is a possibility.

Claims (6)

A tableting composition comprising at least one natural excipient selected from chicory fiber, whole milk powder, yeast and sea tangle extract The tableting composition according to claim 1, wherein the tableting composition further comprises at least one selected from water and alcohol (s). The composition for tableting according to claim 1, wherein the composition for tableting is selected from the group consisting of acerola extract powder, iron powder derived from lactic acid bacteria, zinc dry yeast, calcium alginate powder, Lacto Iron, Lacto Vitamin B6, Lacto B9 folate, MNY dry yeast, dry yeast zinc, (Or two or more) selected from the group consisting of dry yeast manganese, dry yeast molybdenum, dry yeast vitamin B1, dry yeast vitamin B2, dry yeast selenium, rice extract powder magnesium glucan, powdery mildew tea, aloe vera leaves, spirulina and dry yeast biotin A tableting composition comprising a naturally occurring excipient, characterized in that it further comprises The tableting composition according to claim 1, wherein the tableting composition further comprises one or more selected from carbohydrates, minerals, vitamins, functional materials and nutrients as an excipient. A tabletable food composition comprising food and / or food acceptable in the composition of any one of claims 1 to 4 A composition for skin care comprising a health functional food and an excipient acceptable to the health functional food according to any one of claims 1 to 4

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