KR102515460B1 - Method For Preparing Tablet Comprising Arginine And Ginseng - Google Patents

Abstract

The present invention comprises the steps of coating a coating solution containing a hydrophilic polymer on arginine powder; and tableting a mixture containing the coated arginine and ginseng powder. According to the present invention, tablets containing both ginseng and arginine and having quality stability such as properties and hardness can be manufactured. Therefore, even when the tablet is stored for a long period of time, surface cracking may be prevented and hardness reduction of the tablet may not occur.

Description

Method for preparing tablets containing arginine and ginseng {Method For Preparing Tablet Comprising Arginine And Ginseng}

The present invention relates to a method for preparing a tablet containing arginine and ginseng.

Ginseng (Panax ginseng C.A. Meyer) is a perennial herb belonging to the genus Panax of the Araliaceae family. It has herbal medicinal properties such as strengthening the lungs.

The main physiologically active substances of ginseng include saponin, also called ginsenoside, essential oil components, polyacetylene, phenol components, glycosides and acid peptides, and various other components such as vitamins, sugars, and minerals. The physiological activity of ginseng in general has been reported to include central nervous system action, immune function enhancement action, and anticancer action. In particular, about 40 types of ginsenosides have been discovered so far, and it has been confirmed that they have a wide range of effects on the central nervous system, endocrine system, immune system, metabolic system, etc. These ginsenosides may have actions similar to or opposite to each other, and it is known that certain components exert various efficacies alone or through interactions of several types.

Until now, herbal products including ginseng have been generally consumed in the form of liquid extracts or decoctions. However, in recent years, various types of tablets, pills, capsules, jelly types, etc. Research on formulations is being actively conducted.

For example, it can be formulated in the form of pills or tablets containing ginseng. Patent Document 1 discloses a method of producing a red ginseng pill by grinding red ginseng into powder and kneading it with honey.

Research is also being conducted on tablet formulations containing red ginseng, but when manufacturing tablets, red ginseng raw materials, for example, dried powder of red ginseng concentrate, have strong moisture absorption characteristics, As defective products are mass-produced due to the occurrence of king, the tableting machine becomes unreasonable and causes machine failure. In addition, when the manufactured refined product has low hardness, if the pressure of the tablet press is excessively increased to increase the hardness, the tablet press becomes unreasonable and deteriorates. there is. Therefore, with respect to tablets containing red ginseng, studies on tablets and methods for manufacturing the same have been continuously conducted, in which both the ease of manufacture and the quality stability of the final product are secured.

On the other hand, arginine is a kind of essential amino acid and is a source of nitrogen monoxide (NO) in the body. Nitric oxide acts as a strong vasodilator and relaxes the arteries to facilitate blood flow, so it is difficult to treat coronary heart disease such as angina pectoris. diseases and circulation-related diseases such as hypertension. In addition, it is known that arginine has a guanidine group in its molecule as a characteristic functional group, has excellent adsorption to skin and hair, and exhibits effects such as antioxidant action, immunomodulatory function, and wound healing.

While the present inventors were developing tablets containing both ginseng and arginine, these tablets were more vulnerable to moisture than general tablets due to the hygroscopic properties of ginseng and the adsorbing properties of arginine, and the acid-base reaction between ginseng and arginine It was found that water (H ₂ O) affected the swelling of arginine and accelerated the deterioration of tablets. In particular, although tablets containing ginseng and arginine are of good quality immediately after manufacture, cracks and shattering of tablets due to the reaction between ginseng and arginine were found over time. Accordingly, the inventors of the present invention found that physical properties such as properties and hardness of tablets are improved and quality stability is secured by first coating arginine powder using a hydrophilic polymer and then blending it with ginseng powder and tableting, thereby completing the present invention. did

Korean Registered Patent No. 10-1171038

The present invention is a method for manufacturing a tablet containing ginseng and arginine, in which the reaction between components adversely affecting the quality of the tablet is blocked, so that even when the tablet is stored for a long time, the properties and hardness are maintained constant, and thus the quality stability is excellent. It is an object to provide a method for manufacturing tablets.

In addition, an object of the present invention is to provide a tablet containing ginseng and arginine, in which quality stability such as appearance and hardness is secured.

One aspect of the present invention comprises the steps of coating a coating solution containing a hydrophilic polymer on arginine powder; and tableting a mixture containing the coated arginine powder and ginseng powder.

Another aspect of the present invention provides a tablet containing ginseng and arginine prepared by the above manufacturing method.

According to the tablet manufacturing method of the present invention, tablets containing both ginseng and arginine and having quality stability such as properties and hardness can be manufactured. Therefore, even when the tablet is stored for a long period of time, cracking of the surface of the tablet may be prevented and a decrease in hardness of the tablet may not occur.

1 is a photograph of the surface of tablets prepared according to Examples and Comparative Examples.

Hereinafter, the present invention will be described in more detail to aid understanding of the present invention.

Terms or words used in this specification and claims should not be construed as being limited to ordinary or dictionary meanings, and the inventor may appropriately define the concept of terms in order to explain his or her invention in the best way. It should be interpreted as a meaning and concept consistent with the technical idea of the present invention based on the principle that there is.

One aspect of the present invention comprises the steps of coating a coating solution containing a hydrophilic polymer on arginine powder; and tableting a mixture containing the coated arginine powder and ginseng powder.

1. Arginine coating step

The tablet of the present invention contains both ginseng and arginine. In order to solve problems such as cracking of the surface of the tablet and weakening of hardness during long-term storage due to the reaction between ginseng and arginine, the manufacturing method of the present invention is arginine powder. It is characterized in that it comprises the step of coating a coating solution containing a hydrophilic polymer on the.

In the present invention, arginine may be specifically L-arginine. Arginine can be produced by fermentation or extraction from protein in a conventional manner, but is not particularly limited thereto.

The arginine powder may have an average particle diameter of 74 μm to 1 mm, or 105 μm to 500 μm, or 125 μm to 180 μm, but is not limited thereto.

In the present invention, the hydrophilic polymer is a food raw material and food additive having properties capable of lowering reactivity with ginseng powder by being coated on arginine powder, for example, methyl cellulose (MC), hydroxypropyl cellulose ( HPC), Hydroxypropylmethylcellulose (HPMC), Hydroxyethylcellulose (HEC), Hydroxyethylmethylcellulose (HEMC), Polyvinyl Alcohol (PVA), Polydextrose, Sodium Carboxymethylcellulose It may include at least one selected from the group consisting of carboxymethyl cellulose, sodium CMC) and sodium carboxymethyl starch.

The coating solution for coating the hydrophilic polymer on the arginine may include a solvent including at least one selected from the group consisting of water and alcohol, and the alcohol may include ethanol or an aqueous ethanol solution. The ethanol aqueous solution is 5% (v / v) to 99% (v / v) ethanol aqueous solution, or 5% (v / v) to 90% (v / v) ethanol aqueous solution, or 25% (v / v) to It may be 85% (v/v) ethanol aqueous solution, or 30% (v/v) to 80% (v/v) ethanol aqueous solution, or 60% (v/v) to 80% (v/v) ethanol aqueous solution. , but not limited thereto.

The coating solution may include 60 to 99 parts by weight, or 70 to 95 parts by weight, or 80 to 90 parts by weight of the solvent based on 100 parts by weight of the coating solution.

When the solvent includes alcohol and water, the alcohol may be included in an amount of 60 to 100 parts by weight, or 70 to 95 parts by weight, or 80 to 95 parts by weight, based on 100 parts by weight of the solvent, and 0 to 40 parts by weight of water. Part, or 5 to 30 parts by weight, or 5 to 20 parts by weight may be included, but is not limited thereto.

In addition, the coating solution may include a hydrophilic polymer in an amount of 1 to 40 parts by weight, or 5 to 30 parts by weight, or 10 to 20 parts by weight based on 100 parts by weight of the coating solution, but is not limited thereto.

In the present invention, the 'coating' may be performed in a conventional manner. For example, coating may be performed through fluidization and spraying using a fluidized bed coater, but is not particularly limited thereto. In addition, for smooth coating, the size of the arginine powder is adjusted to a particle size suitable for coating through a method such as wet granulation, for example, granules having an average particle diameter of 125 μm to 1 mm, 177 μm to 841 μm, or 250 μm to 500 μm After forming, it can be used for coating.

In the coating step, the coating rate of the hydrophilic polymer calculated according to Equation 1 below may be 5 to 60%, preferably 10 to 40%, and more preferably 15 to 30%. Not limited.

[Equation 1]

Coating rate (%) = (weight of hydrophilic polymer / weight of arginine) × 100

If it is less than the lower limit of the above numerical range, the coating of the hydrophilic polymer on the arginine powder may not be performed smoothly, and if it exceeds the upper limit of the above numerical range, the effect of improving the quality of the tablet according to the coating may be insignificant compared to the input amount of the hydrophilic polymer. .

2. Tableting step

The manufacturing method of the present invention includes tableting a mixture including the coated arginine powder and ginseng powder.

The term 'ginseng powder' referred to in the present invention includes both ginseng pulverized powder obtained by mechanically pulverizing ginseng and ginseng concentrate powder obtained by concentrating and/or drying ginseng extract.

The average particle diameter of ginseng powder used for tablet manufacturing may be 100 μm to 125 μm, or 100 μm to 120 μm, but is not limited thereto. In addition, in order to obtain a particle diameter suitable for tableting, granules having an average particle diameter of 210 μm to 2 mm, or 297 μm to 1 mm, or 595 μm to 840 μm, or 297 μm to 595 μm were prepared through a granulation process with the ginseng powder. After forming, it can be used for tableting. If the size of the ginseng powder is less than the lower limit, problems may occur in flowability during tableting, a capping phenomenon in which the upper portion of the tablet is peeled off from the body, or a laminating phenomenon in which the tablet is horizontally split to form stripes or peeled off in layers may occur. If the amount of ginseng powder exceeds the upper limit, tablets having a uniform surface may not be obtained. However, the particle size of the ginseng powder used may vary depending on the composition and characteristics of the raw material of the tablet to be manufactured.

The ginseng can be used without limitation, such as cultivated or commercially available. The ginseng includes variously processed ones, for example, at least any one selected from the group consisting of fresh ginseng, misam, black ginseng, wild ginseng, camphor ginseng, wild ginseng, dehydrated ginseng, enzyme-treated fine ginseng, fermented ginseng, red ginseng, and fermented red ginseng. It may be one, but is not limited thereto. Fresh ginseng refers to raw ginseng that has maintained its original form, and misam refers to the thin root of ginseng. Red ginseng is raw ginseng that has been steamed, cooked, and dried, and a browning reaction occurs during the drying process, resulting in a light yellowish brown to reddish brown color. Black ginseng refers to ginseng that has changed to black by steaming and drying red ginseng several times. Wild ginseng refers to ginseng that grows naturally, and camphor ginseng refers to wild ginseng that has been planted and grown. Sanyangsam is ginseng cultivated by artificially planting and transplanting seeds or seedlings under forests in the mountains.

When the powder is obtained by grinding the ginseng, the grinding may be performed in a conventional manner and is not particularly limited. The crushing step may be performed in one or more steps.

In the present invention, 'extract' refers to a substance extracted from ginseng by any method, and is used in the sense of including all of the extracted extract, the concentrate obtained therefrom, and the dried product and powder of the concentrate. The extract can be obtained by extracting from ginseng or its dried product, and can also be extracted from the powder of the ginseng or its dried product.

When obtaining an extract from ginseng, the ginseng extract may be obtained from ginseng in a conventional manner. For example, solvent extraction, ultrasonic extraction, filtration and reflux extraction, etc. conventionally known conventional extraction methods can all be used, preferably by using solvent extraction or reflux extraction. The extraction process may be repeated several times, and then additional steps such as concentration or lyophilization may be performed. Specifically, the obtained extract may be concentrated under reduced pressure to obtain a concentrate, and the concentrate may be lyophilized and then a high-concentration extract powder may be prepared using a grinder. The extract also includes fractions obtained by further fractionating the extract.

When obtaining an extract from the ginseng, at least one selected from the group consisting of water, organic solvents, supercritical fluids, and mixtures thereof may be used as an extraction solvent. The organic solvent is an alcohol, preferably a C1-C4 lower alcohol, hexane (n-hexane), ether, glycerol, propylene glycol, butylene glycol, ethyl acetate, methyl acetate, dichloromethane, chloroform, ethyl acetate, benzene and It may be any one selected from the group consisting of these mixed solvents, preferably ethanol. For example, when a mixture of water and an organic solvent is used as the extraction solvent, the mixture of water and the organic solvent may preferably be a mixture of water and a C1-C4 lower alcohol, more preferably a mixture of water and ethanol. may be a mixture.

According to the present invention, since arginine is coated with a hydrophilic polymer and does not react with ginseng powder, the weight ratio of ginseng ground powder, ginseng concentrate powder, and coated arginine powder is not limited to a specific content. However, if the ginseng powder is not in a suitable state for tableting, tableting is not smooth and the binding force of the tablet may be reduced, and if the arginine coating is not properly applied, the surface may become uneven and the hardness may decrease during storage.

The mixture, which is a raw material for tableting, used during tableting may further include at least one selected from the group consisting of an excipient, a binder, a disintegrant, a lubricant, an adsorbent, and a moisturizer.

The excipient may include at least one selected from the group consisting of lactose, starch, sucrose, glucose, dextrin, mannitol, sorbitol, inorganic salts, and cellulose.

The binder is 1 selected from the group consisting of starch paste, sugar syrup, gelatin, CMC sodium (CMC-Na), cellulose derivatives such as hydroxypropyl methylcellulose (HPMC), gum arabic and polyvinylpyrrolidone (PVP) May include more than one species.

The disintegrant is at least one selected from the group consisting of croscarmellose, sodium starch glycolate, CMC-Ca, crospovidone, alginic acid and cellulose derivatives can include

The lubricant may include at least one selected from the group consisting of colloidal silica, talc, calcium stearate, magnesium stearate, stearic acid, magnesium stearate, and sodium stearyl fumarate.

The adsorbent may include at least one selected from the group consisting of colloidal silica, powdered cellulose, and activated charcoal.

The moisturizing agent may include at least one selected from the group consisting of glycerin, propylene glycol, and sorbitol.

Mixing of the coated arginine powder and ginseng powder included in the mixture may be performed in a conventional manner, and is not particularly limited.

In addition, in the present invention, the tableting step may be performed by a conventional method, and for example, it may be performed using rotary tableting equipment such as GRC-15S (Sejong), (KTMD, KTMSA, KTSA, KTSS Series (Keumseong Industrial Machinery), etc. can

Another aspect of the present invention provides a tablet manufactured by the above manufacturing method. For example, the tablet of the present invention may have a hardness of 5 to 30 kp, or 10 to 20 kp, or 10 to 15 kp.

In addition to the coated arginine powder and ginseng powder, the tablet of the present invention may further contain at least one selected from the group consisting of an excipient, a binder, a disintegrant, a lubricant, an adsorbent, and a moisturizer.

Since the same content as described above applies to the coated arginine powder, ginseng powder, other functional materials, excipients, binders, disintegrants, lubricants, adsorbents, moisturizers, and controlled-release additives, other detailed descriptions are omitted.

Hereinafter, the present invention will be described in detail with Examples and Comparative Examples.

However, the following Examples and Comparative Examples are only for exemplifying the present invention, and the content of the present invention is not limited by the following Examples and Comparative Examples.

Example 1

1-1. arginine coating

20 parts by weight of hydroxypropylmethylcellulose (Lotte Fine Chemical) was added to 4 parts by weight of water and 76 parts by weight of ethanol, and mixed to prepare 100 parts by weight of a coating solution.

Hydroxypropylmethylcellulose was coated at a coating rate of 20% on arginine powder having an average particle diameter of 250 μm to 500 μm using a bottom spray fluidized bed coater.

1-2. Manufacture of red ginseng tablets

Red ginseng pulverized powder (Korea Ginseng Corporation) having an average particle diameter of 105 μm before tableting was prepared into wet granules in order to improve flowability and secure a uniform particle diameter of a certain size. The coated arginine powder and pulverized red ginseng powder were separated into uniform particle sizes, and the coated arginine powder and pulverized red ginseng powder were mixed at a ratio of 3:7 and compressed into tablets.

Example 2

2-1. arginine coating

Hydroxypropylmethylcellulose coating was performed on the arginine powder in the same manner as in Example 1-1.

2-2. Manufacture of red ginseng tablets

Red ginseng concentrate powder (Korea Ginseng Corporation) having an average particle diameter of 125 μm before tableting was prepared into wet granules to improve flowability and to secure a uniform particle diameter of a certain size. The coated arginine powder and red ginseng concentrate powder were separated into uniform particle sizes, and arginine powder and red ginseng concentrate powder were further mixed with 1% stearic acid as a lubricant in a ratio of 3:7 to tablet.

Example 3

3-1. arginine coating

Hydroxypropylmethylcellulose coating was performed on the arginine powder in the same manner as in Example 1-1.

3-2. Manufacture of red ginseng tablets

Red ginseng pulverized powder (Korea Ginseng Corporation) having an average particle diameter of 105 μm before tableting and red ginseng concentrate powder (Korea Ginseng Corporation) having an average particle diameter of 125 μm were prepared into wet granules in order to improve flowability and ensure a uniform particle size of a certain size. The coated arginine powder, red ginseng powder, and red ginseng concentrate powder were separated into uniform particle sizes, and arginine powder, red ginseng powder, and red ginseng concentrate powder were mixed with 1% stearic acid as a lubricant in a weight ratio of 2:5:3 and compressed into tablets.

Example 4

4-1. arginine coating

Hydroxypropylmethylcellulose coating was performed on the arginine powder in the same manner as in Example 1-1, except that the coating rate of hydroxypropylmethylcellulose was changed to 30%.

4-2. Manufacture of red ginseng tablets

Red ginseng pulverized powder (Korea Ginseng Corporation) having an average particle diameter of 105 μm before tableting was prepared into wet granules in order to improve flowability and secure a uniform particle diameter of a certain size. The coated arginine powder and pulverized red ginseng powder were separated into uniform particle sizes, and the coated arginine powder and pulverized red ginseng powder were mixed with 1% stearic acid as a lubricant in a ratio of 5:5 and compressed into tablets.

Comparative Example 1

In Example 1, red ginseng tablets were prepared in the same manner as in Example 1, except that arginine coating was not performed.

Experimental example

The tablets prepared in the above Examples and Comparative Examples were left at room temperature for 3 months. Thereafter, the properties of the tablet are observed, and if no cracks are found on the surface of the tablet and the shape and hardness are maintained above the quality standard, it is 'acceptable'. A decrease in was evaluated as 'unsuitable'.

In addition, the hardness was measured using a tablet hardness tester at the beginning and after 3 months of tablet manufacture, and the results are shown in Table 1 below.

In addition, Fig. 1 shows a photograph of the surface of the tablets prepared according to Examples and Comparative Examples after 14 days.

Example 1 Example 2 Example 3 Example 4 Comparative Example 1 appearance fitness fitness fitness fitness incongruity Hardness
(kp) Early 12.5 11.6 12.7 12.4 11.3 3 months later 12.5 11.6 12.7 12.4 2.1

From the above results, in the case of Examples 1 to 3 in which arginine powder was coated with hydroxypropylmethylcellulose at a coating rate of 20% and then mixed with ginseng concentrate powder and / or ginseng pulverized powder and tableted, the tablet properties were constant It can be confirmed that there is no decrease in hardness even when the tablet is maintained and stored for the set shelf life of the tablet.

In addition, even in the case of Example 4 in which the coating rate of hydroxypropylmethylcellulose was 30%, the properties of the tablet were kept constant and there was no decrease in hardness.

On the other hand, in the case of Comparative Example 1 in which the arginine powder was not coated and mixed with ginseng powder, it was found that it was not preferable to manufacture it as a tablet because the hardness was greatly reduced.

Claims (9)

Coating a coating solution containing a hydrophilic polymer on the arginine powder; and
tableting a mixture comprising the coated arginine powder and wet-granulated ginseng powder to have an average particle diameter of 297 μm to 595 μm. The method of claim 1,
The hydrophilic polymer is methyl cellulose (MC), hydroxypropyl cellulose (HPC), hydroxypropyl methyl cellulose (HPMC), hydroxyethyl cellulose (HEC), hydroxyethyl methyl cellulose (HEMC), polyvinyl alcohol (PVA) , A method comprising at least one selected from the group consisting of polydextrose, sodium carboxymethyl cellulose (CMC), and sodium carboxymethyl starch. The method of claim 1,
Method in which the coating rate of the hydrophilic polymer according to Formula 1 in the coating is 5 to 60%:
[Equation 1]
Coating rate (%) = (weight of hydrophilic polymer / weight of arginine) × 100 The method of claim 1,
The ginseng powder has an average particle diameter of 100 μm to 125 μm. The method of claim 1,
The arginine powder has an average particle diameter of 105 μm to 500 μm. The method of claim 1,
The coating solution further comprises a solvent containing at least one selected from the group consisting of water and alcohol. The method of claim 6,
The coating solution is based on 100 parts by weight of the coating solution,
1 to 40 parts by weight of a hydrophilic polymer; and
A method comprising 60 to 99 parts by weight of a solvent. The method of claim 1,
The method of claim 1, wherein the ginseng powder includes ground ginseng powder and ginseng concentrate powder. The method of claim 1,
The method of claim 1, wherein the tablet has a hardness of 5 to 30 kp.

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