KR100603715B1 - Preparation of soft capsules containing persimmon vinegar - Google Patents

Abstract

The present invention relates to a persimmon vinegar-containing process for producing a soft capsule containing a persimmon vinegar concentrate and polyethylene glycols, specifically, a commercially available persimmon vinegar solution to 10 from ² to 10 steps of concentration ^4-fold, the persimmon vinegar concentrate, 20 to 30% by weight of polyethylene glycol The present invention relates to a method for producing a persimmon vinegar-containing soft capsule comprising mixing and stirring 70 to 80 wt% and lecithin 0 to 8 wt% and filling the licorice concentrate composition with a conventional soft capsule film.

Persimmon vinegar, soft capsule, plasticizer, polyethylene glycol

Description

Preparation method of persimmon vinegar-containing soft capsules {Preparation of soft capsules containing persimmon vinegar}

The present invention relates to a method for producing a persimmon vinegar-containing soft capsule comprising a persimmon vinegar concentrate and polyethylene glycol.

More specifically, the step of concentrating the commercial persimmon vinegar 10 ² to 10 ⁴ times, mixing and stirring 20 to 30% by weight of the persimmon vinegar concentrate, 70 to 80% by weight polyethylene glycol and 0 to 8% by weight of lecithin and the It relates to a method for producing a persimmon vinegar-containing soft capsule comprising the step of filling the persimmon vinegar concentrate composition in a conventional soft capsule film.

Persimmon ( Diosoyros kaki ) is an alkaline fruit, rich in nutrition, containing about 11-15% of glucose, fructose and other sugars. Vitamin C contains about 20 to 50 mg, which is about 5 to 12 times the amount of apples per 100g More than this apple, it is rich in vitamin A and contains a lot of tannic acid, which gives off a bitter taste. In particular, tannin is known to play a role in lowering blood pressure without altering ECG as well as pharmacological action that stops diarrhea or improves upset stomach, and is actively researching pharmacological action of persimmon as well as food. .

On the other hand, as a method of maximizing the functional components contained in persimmon vinegar to drink persimmon has been used since ancient times, persimmon vinegar has been recorded in the forest economy (山林 經濟) as a new fruit vinegar in the late Joseon Dynasty. In the case of vinegar, it is widely used as a seasoning all over the world, and vinegar components are very important for human metabolism in 1953 when Krabs and Kipman published the TCA cycle theory. It is known to affect. Vinegar contains acetic acid and a large amount of organic acids involved in the Crab's circuit, so it does not accumulate lactic acid in the body and proceeds smoothly with the Crab's circuit, which is good for fatigue recovery and makes the blood weakly alkaline. As a raw material of such vinegar, various kinds of fruits, cereals, etc. have been used, and the persimmon vinegar produced by fermenting persimmon as a main raw material has better flavor than other vinegars such as apple vinegar or brown rice vinegar, and contains a lot of polyphenol-based tannins. It has been shown to be effective in strengthening blood pressure and strengthening blood vessels. In addition, persimmon vinegar contains acetic acid, which is a main component, and a large amount of organic acid, which is involved in the crab circuit, and is known to be effective for restoring fatigue due to intense exercise or overwork, to improve appetite, and to prevent various adult diseases.

Currently, domestic consumption of persimmon vinegar is used as a seasoning agent for acidic foods when cooking food. However, the direct consumption of health food is to dilute the concentration of persimmon vinegar and drink it like a dietary supplement by adding honey. In general, even a sweet diluent is very painful and difficult to drink because of the strong smell and taste of persimmon vinegar, and because it is a liquid, it is inconvenient to carry and difficult to use as a food material. Was requested. In other words, persimmon vinegar is generally 4% of acidity, so its unique smell and taste is so strong that it is not suitable for direct drinking, and it is liquid, so it is restricted in handling persimmon vinegar, blending with other foods, usability and utility. Therefore, a method of powdering persimmon vinegar was attempted to overcome this problem.

As part of the technique of powdering persimmon vinegar, Korean Patent No. 257771 discloses powdered persimmon vinegar obtained by encapsulating the persimmon vinegar molecule using dextrin's molecular inclusion property, enclosing the fragrance of persimmon vinegar with a gum, and then drying it. The manufacturing method of is disclosed.

In addition, Korean Patent No. 351603 discloses a method of dry powdering by adding excipients such as persimmon leaf extract and dextrin, lactose and gum to the persimmon vinegar concentrate in order to shield the unique aroma and taste of persimmon vinegar during the preparation of persimmon vinegar powder.

However, the powdered persimmon vinegar is not completely removed the acidity of the persimmon vinegar problem when drinking the liquid persimmon vinegar is expressed as it is, if you drink the powder as it is uncomfortable when taking the powder can not be removed.

Therefore, there is a need for a method of reliably shielding the unique aroma and taste of persimmon vinegar for food and drinking, and also convenience of taking it is required.

In general, capsules include hard capsules filled with medicines in gelatin capsules and soft capsules formed by foreskin formation with elastic gelatin membranes, which are encapsulated in gelatin. Unpleasant taste or smell can not be detected, and when wetted in water, it can slip and swallow easily, release of the drug from the capsule is quick, coloring is possible, and the manufacturing process is relatively simple and mass production is possible. It is widely used as the mainstream of solid preparations with tablets.

Among these, the hard capsules may be difficult to completely seal, and may have a phenomenon of absorbing moisture and curing with time.

Soft capsules, on the other hand, are products used in medicines or health supplements, and have the advantages of high stability, easy absorption in the digestive system, and simple ingestion. In general, soft capsules are filled with medicines with liquid, paste, and tablet formulations between two capsule bases (base capsules, corresponding to the outer coating of capsules), which are plasticized by adding plasticizers such as glycerol and sorbitol to gelatin. It is manufactured by compression molding using (型).

The inventors of the present invention have been searching for a method for effectively masking the unique taste and aroma of persimmon vinegar and facilitating the eating and drinking of persimmon vinegar, and manufacturing a soft capsule containing the persimmon vinegar concentrate not only suppresses the loss of the active ingredient but also greatly eases the taking. The present invention was completed by confirming the increase.

 It is an object of the present invention to provide an optimal method for producing a persimmon vinegar-containing soft capsule that effectively masks the sour taste of persimmon vinegar to facilitate taking of persimmon vinegar.

In order to achieve the above object, the present invention provides a method for producing a persimmon vinegar-containing soft capsule containing a persimmon vinegar concentrate and polyethylene glycol.

In another aspect, the present invention is the step of concentrating the commercial licorice vinegar 10 ² to 10 ⁴ times, mixing and stirring 20 to 30% by weight of the licorice concentrate, 70 to 80% by weight polyethylene glycol and 0 to 8% by weight of lecithin and the persimmon vinegar It relates to a method for producing a persimmon vinegar-containing soft capsule comprising the step of filling the concentrate composition into a conventional soft capsule film.

Hereinafter, the present invention will be described in detail.

First, in the present invention, the persimmon vinegar concentrate is used as the active ingredient in persimmon vinegar-containing soft capsules.

It is preferable that the said persimmon vinegar concentrate concentrates the density | concentration to about 10 <^2> -10 <^4> times using commercially available persimmon vinegar.

As used herein, "commercial persimmon vinegar" refers to a persimmon vinegar solution made by acetic acid fermentation or diluted in a certain concentration, and distributed in the market, and its concentration is about 2 to 5 ° Brix.

At a concentration less than 10 ² times that of commercially available persimmon vinegar, it contains up to approximately 70 to 80% of water, so that even when emulsified using a fat-soluble base when preparing a capsule content of a soft capsule, it is separated without transferring to an emulsion or suspension state. Therefore, molding with a soft capsule is almost impossible.

That is, when the commercial persimmon vinegar is concentrated approximately 10 ² times or more, the stability of the formulation can be achieved.

As a plasticizer contained in the content of the soft capsule agent in this invention, polyethyleneglycol which is a water-soluble base is preferable. More preferably, it is polyethylene glycol 400. Alternatively, lecithin may be used.

When the persimmon vinegar concentrate containing a large amount of water using a fat-soluble base as a plasticizer is forcibly mixed with the fat-soluble base, the water phase and the oil phase of the capsule contents are separated.

That is, in the production of persimmon vinegar-containing soft capsules according to the present invention, the concentration of the persimmon vinegar concentrate to be used and the kind of plasticizer to be used serve as important factors. When using a persimmon vinegar concentrate with a high moisture content, it is important to reduce the water content by concentrating more than 10 ² times of commercial persimmon vinegar, and also to mix with an aqueous base to transfer the capsule contents to an emulsion or suspension state without separating them from each other. Do. If even concentration of the commercially available persimmon vinegar solution at least 10 ² times the concentration of emulsion is mixed with a lipid-soluble base is separated from the capsule contents the capsule film as the time has passed after molding the soft capsule stability of such formulations split film of the capsule This falls extremely.

Specifically, the capsule content of the present invention preferably contains 20 to 30 wt% of the persimmon vinegar concentrate, 70 to 80 wt% of polyethylene glycol, and 0 to 8 wt% of lecithin.

The soft capsule coating according to the present invention can be formulated and used in a conventional manufacturing method by a conventional soft gel formulation.

Specifically, in the present invention, gelatin, concentrated glycerin, and D-sorbitol solution are mixed, stirred with the addition of purified water, and then a soft capsule is molded by a conventional filling method using a rotary automatic filling machine which is a general method.

In addition, the soft capsule containing the persimmon vinegar of the present invention is molded as described above and made into a prototype through a drying and sorting process.

Persimmon vinegar-containing soft capsule of the present invention comprises the steps of concentrating the commercially available persimmon vinegar solution 10 times ^{from 2} to 10 ^4; Mixing 20 to 30% by weight of the persimmon vinegar concentrate, 70 to 80% by weight of polyethylene glycol, and 0 to 8% by weight of lecithin; And filling the persimmon vinegar concentrate composition with a conventional soft capsule film.

The soft capsule containing persimmon vinegar prepared by the above method showed good results in stability, disintegration and dissolution test. In particular, there was no leakage phenomenon in which the film and the contents were separated or the film was cracked, which showed excellent results in terms of stability.

The present invention will be described in more detail with reference to the following examples, but the scope of the present invention is not limited to these examples, and various modifications and variations are possible within the protection scope of the present invention described in the claims. It will be apparent to those of ordinary skill in the art.

Example 1 Preparation of Persimmon Vinegar-Containing Soft Capsule

As a persimmon vinegar, 10 ² times the concentration of commercially available persimmon vinegar was used.

75% propylene glycol was added to a preparation tank preheated to 25 to 30 ° C., followed by adding persimmon vinegar x 20% and lecithin 5%, followed by stirring to prevent foaming in a stirrer rotating 60 times per minute.

Next, the coating composition was poured into a dissolving tank preheated at 70 ° C., 9 kg of purified water, 3 kg of concentrated glycerin, and 2 kg of D-sorbitol solution while stirring, adjusting the controller to 90 ° C., followed by defoaming after adjusting the controller to 90 ° C. In this case, 'defoaming' refers to a process of removing bubbles.

The capsule contents and the coating composition were transferred to an M3 molding machine, and then the extension and the guide were preheated and molded.

Comparative Example 1 Preparation of Persimmon Vinegar-Containing Soft Capsule

Composition of capsule contents ingredient Persimmon cooking oil Coconut Cured Oil White lead lecithin Twin 80 weight% 20 65 10 3 2 0 20 60 13 5 2 0 20 60 0 8 2 10 20 60 0 8 2 10 20 65 0 0 2 13 15 60 15 8 2 0 15 65 13 5 2 0 15 65 0 5 2 13 15 60 0 8 2 15 15 55 13 3 2 12 10 60 20 8 2 0 10 60 18 10 2 0 10 65 0 10 2 13 10 65 0 8 2 15 10 60 0 8 2 10

The persimmon vinegar extract used 10 times the concentration of commercially available persimmon vinegar. The preparation tank preheated to 25-30 ° C. was mixed in the formulation of Table 1 above and stirred in a stirrer rotating 60 times per minute.

However, according to the prescription according to Table 1, even if the persimmon vinegar X was emulsified in a fat-soluble base, all of them were separated without transferring to an emulsion or suspension state, and molding into a soft capsule was impossible.

Comparative Example 2 Preparation of Persimmon Vinegar-Containing Soft Capsule

Persimmon vinegar was mixed in the formulation of Table 1 using 10 ² times the concentration of commercially available persimmon vinegar and stirred in a stirrer rotating 60 times per minute.

Preparation of the coating composition and molding of the soft capsule were carried out in the same manner as in Example 1.

Test Example 1 Evaluation of Stability of Formulations

The soft capsules prepared according to Example 1 were subjected to a long-term storage test to evaluate the stability.

In order to establish the shelf life under storage conditions, soft capsules were stored at room temperature as a method for establishing physicochemical and biological stability of medicines over a long period of time and analyzed whether they meet the criteria of Table 2 at regular intervals.

Stability Test Criteria Item standard Test Methods Constellation Brown soft capsule with dark brown contents Visual observation Weight deviation Within ± 10.0% Complies with the Korean Pharmacopoeia General Test Method Disintegration test Within 20 minutes (water) Complies with the Korean Pharmacopoeia General Test Method content 95.0-105.0% Method by measuring total acidity

A total of 9 samples were used for 3 lots (3 per lot), and the storage conditions were stored for 12 months at a temperature of 25 ± 2 ° C and a relative humidity of 60 ± 5%. The test items were analyzed in.

The appearance was found to be good for all three lots of mash points.

Weight deviation Lot number Start of test 3 months 6 months 9 months 12 months 02001 Highest +2.3 +2.1 +2.2 +2.7 +1.9 Lowest -0.9 -0.8 -1.0 -1.9 -1.0 02003 Highest +0.8 +1.7 +2.6 +1.1 +3.0 Lowest -0.6 -1.4 -2.0 -0.9 -2.0 02005 Highest +1.9 +1.7 +2.4 +2.4 +3.0 Lowest -1.0 -2.1 -0.7 -1.4 -1.5

content Lot number Start of test 3 months 6 months 9 months 12 months 02001 101.2 99.4 100.5 100.4 99.7 02003 99.0 99.8 100.5 99.7 99.7 02005 99.9 100.8 100.3 100.3 99.4 Average 100.4 100.0 100.4 100.3 99.6

Disintegration Test Lot number Start of test 3 months 6 months 9 months 12 months 02001 6'01 " 7'28 " 8'09 " 7 "25" 8'15 " 02003 7'57 " 7'29 " 8'18 " 8'09 " 8'23 " 02005 7'48 " 7'33 " 8'28 " 8'12 " 8'39 "

As can be seen in Table 3, all the weight deviations satisfy the criteria within ± 3.0%, and as can be seen in Table 4, the content is maintained in the range of 99.6 to 100.4%, prepared as shown in Table 5. Immediately after, all three formulations of three lots (three per lot) disintegrated within 7.57 minutes, meeting the disintegration test criteria of the Korean Pharmacopoeia that "should disintegrate within 20 minutes and leave no sample residue."

The change of appearance with time of the soft capsule manufactured by the comparative example 2 was observed visually.

As a result, the capsule contents were separated from the coating and the soft capsule coating cracked over time. That is, in the case of forming a soft capsule, the adhesion defect was 30%, and after 1 hour, the adhesion defect was 20% (50% in total). In addition, the film cracking phenomenon was less than 10% after 4 hours, 12 hours, 24 hours, 48 hours, 72 hours after molding, but the leakage phenomenon was larger as time passed.

<Test Example 2> Dissolution test of the formulation

Three lots (3 per lot) of soft capsules containing persimmon vinegar prepared according to Example 1 were used in accordance with the dissolution test method of the Korean Pharmacopoeia General Test Method using a total of nine formulations. As the eluate, 500 ml of the third solution (water) of the Pharmacopoeia Disintegration Test was used, and it was tested according to the Dissolution Test Method 2 (paddle method). For quantification, the dissolution rate was calculated by calculating the acidity yield by measuring the total acidity.

Lot number 2.5 minutes 5 minutes 7.5 10 20 30 40 60 90 120 02001 5.2 18.3 53.7 82.0 99.2 100.8 100.7 100.6 100.3 100.5 02003 3.8 14.3 55.3 71.1 99.9 100.3 100.3 100.3 100.6 100.3 02005 3.2 15.3 59.1 95.0 99.5 100.6 100.4 100.2 100.7 100.3

As can be seen from the table, the same degree of dissolution was shown for the three manufactured lot products, and was eluted at about 70% or more in 20 minutes within 10 minutes.

This is because, as confirmed in Test Example 1, since all of the preparations disintegrate within 8 minutes, the content solution solubilized in the capsule dissolves into the eluate when the soft capsule base disintegrates.

As described above, when the concentration of the commercially available persimmon vinegar solution according to the invention with more than 10 ² times, and to miscible with the water-soluble base is polyethylene glycol manufacturing the soft capsule it can be produced excellent persimmon vinegar-containing soft capsule in the stability of the preparation Persimmon vinegar is completely masked for its tasting taste and aroma.

Claims (3)

Concentrating the persimmon vinegar stock solution 10 ² to 10 ⁴ times, mixing 20 to 27% by weight of the persimmon vinegar concentrate, 70 to 77% by weight polyethylene glycol and 3 to 8% by weight lecithin and stirring the persimmon vinegar concentrate composition A method for producing a persimmon vinegar-containing soft capsule comprising the step of filling the soft capsule film. The method of claim 1, wherein the polyethylene glycol is polyethylene glycol 400, a method for producing a persimmon vinegar-containing soft capsule. The soft capsule coating according to claim 1, wherein the soft capsule coating is prepared by mixing, stirring, and defoaming gelatin, concentrated glycerin, and D-sorbitol solution.