KR100720817B1 - Preparation containing plant extracts and method to manufacture the same - Google Patents

Abstract

The present invention discloses a plant extract-containing preparation and a method for producing the same. The plant extract-containing preparation according to the present invention and a method for preparing the same are coated on a pellet seed, in particular, a pellet extract of sucrose or microcrystalline cellulose, and coated with a concentrate of a plant extract, in particular, aloe extract or green tea extract, By forming a coating film, it can effectively mask the unpleasant taste of plant extracts, especially the bitter taste of aloe extract or the astringent taste of green tea extract, thus increasing the content of the extract while being suitable for consumer use of the product. In addition, the manufacturing process can be simplified to increase the production efficiency. In addition, it is easy to adjust the elution pattern of the extract by the coating amount of the coating agent, the final particle size can be freely selected by simple operation in the manufacturing process, the appearance of the prepared final product is excellent, well mixed with excipients, etc. In addition, the plant extract, particularly aloe extract or green tea extract, is very suitable for use as a dietary supplement or medicine. Furthermore, the plant extract containing formulations especially containing lactic acid bacteria according to the present invention are effective in improving constipation, such as improving constipation symptoms and increasing the number of bowel movements, and are excellent in ease of taking, and also excellent in palatability such as taste of the product. To achieve.

Aloe extract, green tea extract, bitter, astringent, pelleted, fluidized bed, coating, constipation improvement

Description

Formulations containing plant extracts and a method for producing the same {PREPARATION CONTAINING PLANT EXTRACTS AND METHOD TO MANUFACTURE THE SAME}

1 is a schematic view showing the configuration of a formulation containing an aloe extract according to an embodiment of the present invention,

2A is a schematic diagram showing a bottom spray coating apparatus for the preparation of a formulation according to one embodiment of the present invention;

Figure 2b is a schematic diagram showing an enlarged interior of the production container in Figure 2a,

Figure 3 is a graph showing the extract dissolution rate with time of the preparation containing aloe extract according to Examples 1 to 3 and Comparative Examples of the present invention,

4 is a graph showing a comparison of evaluation results regarding the degree of improvement in constipation symptoms of the formulation of Example 1 and the formulation of Example 4 containing lactic acid bacteria in Test Example 3 of the present invention;

FIG. 5 is a graph showing an evaluation result regarding the degree of change in defecation frequency of the formulation of Example 1 and the formulation of Example 4 containing lactic acid bacteria in Test Example 3 of the present invention;

FIG. 6 is a graph showing a comparison of evaluation results regarding product taste satisfaction of the formulation of Example 1 and the formulation of Example 4 containing lactic acid bacteria in Test Example 3 of the present invention;

FIG. 7 is a graph showing the evaluation result regarding the degree of ease of defecation of the formulation of Example 1 and the formulation of Example 4 containing lactic acid bacteria in Test Example 3 of the present invention;

8 is a graph showing a comparison of the results of the evaluation of the effects of the formulation of Example 1 and the formulation of Example 4 containing lactic acid bacteria in Test Example 3 of the present invention;

9 is a graph showing a comparison of evaluation results regarding the satisfaction of the efficacy of the formulation of Example 1 and the formulation of Example 4 containing lactic acid bacteria in Test Example 3 of the present invention;

Fig. 10 is a graph showing the evaluation results regarding the ease of taking of the formulation of Example 1 and the formulation of Example 4 containing lactic acid bacteria in Test Example 3 of the present invention.

* Description of the main parts of the drawings *

1: pellet seed 2: first coating layer

3: 2-1 coating layer 4: 2-2 coating layer

10: filter housing 20: expansion chamber

30: Production container 31: Coating chamber

32: plate-type air dispersion plate 33: spray nozzle

34: injection 35: particle flow

36: partition

The present invention relates to a preparation containing a plant extract and a method for producing the same, and in particular, when the plant extract, in particular, aloe extract or green tea extract is applied orally ingested in a dietary supplement or medicine, etc. Unpleasant taste, in particular, the aloe extract, the bitter taste or the green tea extract can hide the astringent taste, and also the content of the extract is high, and further contains lactic acid bacteria, especially effective in improving constipation symptoms, The present invention relates to a formulation containing a plant extract, which is excellent in convenience and taste of a product, and a method for producing the same.

Plant extracts have been applied to a variety of dietary supplements and medicines. As many uses in recent years, the extract from aloe and green tea etc. are typical, for example.

The aloes are generally classified into ornamental aloes, pharmacopoeial aloes, and edible (medical) aloes.The ornamental aloes include rekulbifolia and eugenda. Aloe, Curranso Aloe, and edible (medicinal) Aloe are typically Aloe Vera and Aloe Aborescens. Among them, aloe aborescens promotes the secretion of gastric acid, which facilitates blood circulation of the stomach wall, thereby promoting the movement of the stomach, promoting the cardiac function, and promoting the blood circulation, and the anthraquinone-based substance contained in the intestinal peristalsis It is known to actively help with bowel movements.

On the other hand, the green tea contains a large amount of polyphenols, unlike the general plants are known to have various physiological activities such as anticancer effect, antioxidant effect, antibacterial effect. Among the polyphenols, catechin is well known as an ingredient that shows the efficacy of green tea. Especially, EGCg in green tea catechin has antioxidative effect to lower cholesterol, triglyceride elevation inhibition, anti-tumor, anti-cancer and skin care, obesity inhibition, heavy metals. Clinical trials have reported a number of effects, including elimination, mutagenicity, hypotension, central nervous system activation, and cardiovascular disease.

Due to such usefulness, plant extracts such as aloe or green tea extracts are increasingly used in the fields of health supplements and medicines.

However, in plant extracts that can be used in the fields of dietary supplements and medicines, the bitter or astringent taste may cause discomfort to oral intake. In particular, aloe extract has a unique bitter taste, and green tea extract Astringent taste is present, which significantly impairs intake.

Therefore, in order to conceal such unpleasant taste when ingesting the plant extract, various methods or various forms of preparations have been developed.

For example, a tablet-type formulation coated with fructose or the like which has a sweet taste after formulation, or a formulation formulated in powder or granule form is mainly used for those who have difficulty in taking such a tablet form.

However, in the case of infants, children, the elderly, or the like, the oral intake of the tablet-type preparation is uncomfortable or burdensome, and also has the disadvantage of causing discomfort due to the bitter taste of the drug.

In addition to the above tablet formulations, they may be formulated in granule form or dry syrup.

However, the general granular form is a situation that does not completely conceal the unpleasant taste of the plant extract, and also has a problem that the content of the extract is relatively low, about 30 to 40%.

In the case of the dry syrup, there has been a method of improving the bitter taste of the drug by chemical and technical operations or by changing the pharmaceutical composition. For example, a method of using lipoprotein to form a complex with a drug to conceal bitter taste, or a method of adding a fragrance or sweetener to a pharmaceutical composition has been developed. However, these methods also did not completely conceal the unpleasant taste such as bitterness or astringent taste, and the content of the extract was also not satisfactory.

On the other hand, the following are known with respect to the technique of concealing the unpleasant taste of the drug.

That is, Japanese Unexamined Patent Application Publication No. Hei 4-282312 discloses a method of coating a granule with a water-soluble coating, and Japanese Unexamined Patent Application Publication No. Hei 7-267850 melts waxes having a melting point of 40 to 100 ° C. in it. A method of obtaining a powdered medicine by dispersing and solidifying a drug having an unpleasant flavor is disclosed. On the other hand, Japanese Patent Laid-Open No. 4-346937 discloses a method of reducing bitter taste through mixing with a gelatin agent.

However, such techniques also have a problem that the manufacturing process is complicated or insufficient effects do not effectively mask the unpleasant taste.

Therefore, it is suitable for oral ingestion by sufficiently concealing the bitterness or astringent taste of the plant extract, especially aloe extract or green tea extract, while at the same time increasing the content of the extract, the unpleasant taste of the plant extract is not complicated. Formulations for concealment and methods for producing them have been sought after.

Furthermore, when taking a plant extract or a drug selected to ameliorate symptoms such as constipation, there is a need for a formulation that has no resistance to taking the recipient and has high potency.

Accordingly, the present invention has been made to solve the above problems and needs,

An object of the present invention, when orally ingested a plant extract, especially aloe extract or green tea extract, can effectively conceal the peculiar bitterness or astringent taste, and also contain a plant extract which can increase the content of the extract. To provide a formulation.

Another object of the present invention, when orally ingested plant extracts, particularly aloe extract or green tea extract, can effectively conceal the peculiar bitter or astringent taste, increase the content of the extract, the manufacturing process is simple, It is to provide a method for the preparation of a formulation containing a plant extract.

It is still another object of the present invention to provide a preparation containing a plant extract having an excellent effect on improving constipation, such as improving constipation symptoms and increasing the number of bowel movements, and which is easy to take and excellent in taste such as the taste of the product.

The object of the present invention as described above, pellet seed (seed) (1); A first coating layer (2) of concentrated plant extract formed on the seed (1); A shellac (shellac) or a cellulose-based coating base 2-1 coating layer (3) formed on the coating layer (2); And a second-2 coating layer 4 of shellac or cellulose-based coating base formed on the second-2 coating layer 3.

Another object of the present invention as described above, the step of forming a first coating layer (2) by coating the concentrated plant extract on the pellet seed (1); Coating a shellac or cellulose-based coating base dissolved in a solvent on the first coating layer 2 to form a 2-1 coating layer 3 (S2); And coating the shellac or cellulose-based coating base dissolved in the solvent on the second-first coating layer 3 to form the second-second coating layer 4 (S3). It is achieved by a method for the preparation of a formulation containing an extract.

Another object of the present invention as described above, the plant extract is achieved by a formulation containing a plant extract further comprises lactic acid bacteria. In addition, the formulation containing the plant extract is preferably used for improving constipation.

Hereinafter, the preparation containing the plant extract according to the present invention and the preparation method thereof will be described in detail.

First, the preparation containing the plant extract according to the present invention will be described in detail.

Figure 1 is a schematic diagram showing the configuration of a formulation containing a plant extract according to an embodiment of the present invention.

The preparation containing the plant extract according to the present invention comprises, first, a pellet seed (1) used as a core, a first coating layer (2) of the concentrated plant extract coated on the pellet seed (1), said The second coating layers 3 and 4 of shellac and / or cellulosic coating base formed on the first coating layer 2 are included.

At this time, the second coating layer (3, 4) of the shellac 2-1 coating layer 3, and the 2-2 coating layer of the cellulose-based coating base formed on the 2-1 coating layer (3) It is suitable in terms of providing a double coating film as described below to more effectively conceal the unpleasant taste of the plant extract.

In addition, the second-2 coating layer 4 preferably further includes silicon dioxide to prevent caking and static electricity.

The pellet seed (1) is preferably composed of white sugar or microcrystalline cellulose, wherein the pellet seed (1) is more preferably a pellet seed of 200 to 800㎛, particles of such a pellet seed (1) Size is an important factor in determining the final particle size as described below. In addition, as the pellet seed 1, when the cyclic pellet seed is applied, the coated final particles also have a ring shape, which is preferable in appearance.

As the concentrated plant extract forming the first coating layer 2, it is suitable to use concentrated aloe extract as shown in Figure 1, or concentrated green tea extract.

In the case of the concentrated aloe extract, the aloe powder is concentrated to a high concentration using ethanol (alcohol), and in the case of the concentrated green tea extract, the green tea powder is concentrated to a high concentration using alcohol (alcohol).

According to the present invention, as can be seen in the following Examples 1 to 3, the content of the plant extract (aloe extract) is more than 50%, and forms a separate coating layer on the pellet seed, which is the core, high concentration of 80-90% or more There is no difficulty in the content of.

The aloe powder uses, for example, aloe vera, aborescens extract powder of Martin Bauer, France, in particular one selected from aloe powder containing sugar or dextrin as excipient.

The green tea powder is suitably applied to the catechin content of the green tea component is in the range of 30 to 95% by weight.

The shellac is a material resistant to water or acid, and forms a coating layer of the shellac, in particular, the second-1 coating layer 3 of the shellac, thereby blocking the hygroscopicity of the first coating layer 2 and Elution of the extract from the coating layer 2 can be properly maintained.

As the cellulose-based coating base, it is suitable to apply methyl cellulose, ethyl cellulose or hydroxypropyl methyl cellulose, or a mixture of two or more thereof. In particular, first forming a coating film of shellac, and then, second, forming a coating film using the cellulose-based coating base as described above, unpleasant taste of plant extracts, in particular, bitter taste of aloe extract or astringent taste of green tea extract Can be shielded almost completely.

Meanwhile, to the above formulations, white sugar or microcrystalline cellulose is applied as the pellet seed 1, the concentrated aloe extract or the concentrated green tea extract is applied to the first coating layer 2, and the shellac is applied to the second-1 coating layer 3 And, in the case of applying the silicon dioxide and the cellulose coating base to the 2-2 coating layer 4, containing 10 to 70 parts by weight of the white sugar or microcrystalline cellulose, the concentrated aloe extract or concentrated green tea extract 10 to 90 It is preferably included in parts by weight, 0.1 to 5 parts by weight of the shellac, 0.1 to 2 parts by weight of the silicon dioxide, and 1 to 10 parts by weight of the cellulose-based coating base.

When the white sugar or microcrystalline cellulose is less than 10 parts by weight, the dosage of the coating material is increased, and thus there is a problem of an increase in cost due to an increase in working time. When it exceeds 70 parts by weight, the content of the active ingredient becomes small. It is not preferable because there is a problem of function expression.

When the concentrated aloe extract or the concentrated green tea extract is less than 10 parts by weight, the content of the active ingredient is reduced to cause a problem of the expression of the function, if it exceeds 90 parts by weight, the formation of a double coating film for the unpleasant taste masking This is not desirable because it is not done efficiently.

When the shellac is less than 0.1 part by weight, the hygroscopicity blocking effect of the coating layer of the concentrated aloe extract or the coating layer of the concentrated green tea extract is inferior, and when it exceeds 5 parts by weight, there is a limit in dissolution of the extract. On the other hand, when 2 to 3 parts by weight of the shellac is applied, more preferable results can be obtained in terms of hygroscopicity blocking or extract dissolution.

When the silicon dioxide is less than 0.1 part by weight, it is not suitable for preventing the caking phenomenon and antistatic at the time of coating, and when it exceeds 2 parts by weight, it is not preferable because it causes elution delay of the active ingredient.

When the said cellulose coating base is less than 1 weight part, it is difficult to fully conceal bitterness, and when it exceeds 10 weight part, there exists a possibility that the elution of an extract may become difficult.

In this case, in particular, the weight ratio of the white sugar or the microcrystalline cellulose constituting the concentrated aloe extract or the concentrated green tea extract and the pellet seed (that is, the weight of the plant extract: the weight of the white sugar or the microcrystalline cellulose) can be optimized. More preferably, the weight ratio is 1: 4 to 4: 1.

Outside of the above range, that is, when the weight ratio of the pellet seed of sucrose or microcrystalline cellulose is greater than that of the concentrated plant extract, the effective ingredient becomes smaller and the difficulty in expressing the efficacy occurs, and the pellet seed of the sucrose or microcrystalline cellulose compared to the concentrated plant extract When the weight ratio of is smaller, the coating material is increased, so that the working time is delayed and the production cost is increased accordingly.

In this case, sweeteners, fragrances, flavorings, coloring agents, ordinarily used in the sugar or microcrystalline cellulose, plant extracts, or shellac and / or cellulose coating bases of the above formulations, respectively, in order to increase the dosage. Or two or more additives such as stabilizers, thickeners, extenders, preservatives, pH adjusters, excipients or copulation agents.

The sweetener may serve to further mask bitter taste, with respect to a total of 1 part by weight of each or two or more of white sugar or microcrystalline cellulose, plant extracts, or shellac and / or cellulose coating bases used in the formulation, It is preferable to contain 0.5-2 weight part of sweeteners from a viewpoint of dosage. As such a sweetener, white sugar, glucose, D-sorbitol, etc. can be used, for example.

The fragrance may be orange oil, juice extract, cinnamon oil, spearmint oil, peppermint, vanilla, peppermint oil, rose oil, lemon oil, and the like.

In addition, the formulation, by adjusting the coating amount of the coating layer (2, 3, 4), by adjusting the content of the extract, by adjusting the dissolution pattern of the extract can be designed to match the physiological activity of the human body taking it In addition, it becomes possible to appropriately conceal an unpleasant taste.

And, the final particles formed are suitable to have a range of approximately 300 to 1000㎛ by adjusting the size of the seed, coating amount, etc., and furthermore, apparently suitable to be cyclic, which is a cyclic granule formulation having an aloe extract in the coated formulation. In this case, the appearance of the product is particularly excellent.

The coated formulations are very suitable for use in dietary supplements or medicaments, when formulating the supplements or medicaments, pharmaceutically acceptable carriers, excipients, binders, disintegrants, solubilizers, suspending agents, Each or two or more of a preservative or a weight agent may be included. In particular, the coated agent may be mixed well with excipients such as sugar alcohol, dextrin, starch, sucrose, and the like.

In the dietary supplement or medicine, the effective dose of the coated formulation is 500 to 2000 mg / sachet (2.5 g), preferably 1000 to 1500 mg / sachet (2.5 g), to be administered 1-2 times a day Can be.

However, the dosage level for a particular consumer may vary depending on the weight age, sex, health condition, diet, time of administration, administration method, excretion rate, residual feeling, smooth bowel movement, severity of disease, and the like.

Such supplements or medicines are effective in constipation and other anti-cancer, antibacterial, blood circulation.

In the present invention, in order to improve the constipation improvement effect, especially constipation symptom improvement, increase in the number of bowel movements, lactic acid bacteria were added to the vegetable extract. The most effective combination for improving constipation symptoms is to use aloe extract as a plant extract and add lactic acid bacteria to it.

Lactic acid bacteria that can be used include lactobacillus, lactococci, bifidus and the like.

Examples of the lactic acid bacterium include L. acidophilus, L, casei, L. gasseri, L, delbrueckii, L. helveticus, L. fermentum and the like.

The lactic acid bacterium includes, for example, S.thermophilus, S.lactis, E.faecium, E.faecalis, and the like.

The bifidus bacteria means, for example, cultivated in B. bifidum, B.infantis, B.brave, B.longum and the like suitable for edible.

As the amount of use, it is preferable to use the lactic acid bacteria alone or in a mixture of 10 ⁷ to 10 ¹⁰ / g, more preferably 10 ⁸ / g.

As can be seen in Test Example 3, even when tested with the plant extract Aloe extract itself shows the effect of improving constipation symptoms, the effect of increasing the number of bowel movements, reducing the residual feeling, facilitating bowel movements (ie, improving constipation) It is excellent in the speed of manifestation of the effect, satisfaction of the efficacy, ease of taking, and shows no effect of embryonic symptoms.

Furthermore, in the case of the formulation with lactic acid bacteria added to the aloe extract, compared to the case without the addition of lactic acid bacteria, constipation symptoms are improved, the frequency of defecation is increased, the ease of taking or taste of the product is better Done.

Next, a method for preparing a coated formulation covering the unpleasant taste of the plant extract according to the present invention will be described in detail.

Figure 2a is a schematic diagram showing a bottom spray coating apparatus for the preparation of the formulation, according to an embodiment of the present invention, Figure 2b is a schematic diagram showing an enlarged interior of the production vessel 30 in Figure 2a.

As shown in FIG. 2A, the apparatus for bottom spray coating comprises a filter housing 10, an expansion chamber 20 opened below the filter housing, and a production vessel 30 opened below the expansion chamber. As shown in FIG. 2B, the production container 30 includes a coating chamber 31 and a dish-shaped air dispersion plate 32 opened below. The coating chamber 31 is provided with a partition 36 for coating and an injection nozzle 33 inside the partition 36, and for coating into the partition 36 from the spray nozzle 33. Injection liquid is injected. In the interior of the coating chamber 31, the flow of particles 35 is controlled to proceed into the coating partition 36, and after coating, the particles in the coating chamber 31 proceed to the expansion chamber 20. .

First, through the coating apparatus as described above, the concentrated plant extract is coated on the pellet seed 1 to form the first coating layer 2 (S1).

At this time, it is preferable to use white sugar or microcrystalline cellulose as the pellet seed (1). As a concentrated plant extract, aloe powder is dissolved in ethanol (alcohol), and green tea powder is dissolved in the concentrated aloe extract concentrate or ethanol (alcohol). It is preferable to use the concentrated green tea extract concentrate, in which case, the sugar or microcrystalline cellulose is flowed into the pellet seed (1), and the aloe powder concentrate is dissolved by dissolving aloe powder in ethanol (alcohol). It is more preferable to coat by dissolving the green tea powder in to spray the concentrated green tea extract concentrate by the bottom spray method.

That is, aloe powder is dissolved in ethanol (alcohol) and dissolved in a high concentration in a fluidized bed granulator (Glatt, GPCG-1), while flowing sugar or microcrystalline cellulose pellets as seeds (1), in particular cyclic pellets as seeds (1). Green tea powder was dissolved in aloe extract concentrate or ethanol (alcohol) concentrated by spraying the concentrated tea extract concentrate concentrated at high concentration through a nozzle using a bottom spray method, so that the pellet seed (1) Apply the coating layer (2). At this time, by adjusting the desired content, it is possible to coat the first coating layer (2) of aloe or green tea, and to have a content of about 80 to 90% by weight or more.

On the other hand, as described above, when lactic acid bacteria are added to plant extracts such as aloe extract, an effective amount of lactic acid bacteria is added to the concentrated plant extracts, and the concentrated liquid to which the lactic acid bacteria are added is sprayed through a nozzle by a bottom spray method.

Next, the shellac and / or cellulose-based coating base dissolved in the solvent is coated on the first coating layer 2, for example, by bottom spray coating, to form the 2-1 coating layer 3 and the 2-2 coating layer ( 4) (S2, S3).

Meanwhile, at this time, forming the shellac 2-1 coating layer 3 first (S2), and forming the 2-2 coating layer 4 of the cellulose-based coating base thereon (S3) to form a double coating film It is preferable because it effectively masks an unpleasant taste.

It is preferable to use alcohol as a solvent in the step S2 or S3, it is preferable to dissolve the cellulose-based coating base in the solvent with silicon dioxide in the step S3, it is preferable to use a mixture of ethanol and purified water as the solvent. In this case, the ethanol and purified water are used in a mixture of 7: 3 based on the weight ratio, so that the spraying, drying and fluidity of the coating solution is good, it is suitable for work.

It is more preferable to use at least one selected from the group consisting of methyl cellulose, ethyl cellulose and hydroxypropyl methyl cellulose as the cellulose-based coating base.

Although the present invention has been described in particular focusing on reducing the unpleasant taste of plant extracts, the present invention is not limited thereto. In addition to the plant extracts, the present invention is also applicable to various drugs having difficulty in oral administration due to the unpleasant taste. It will be understood by those skilled in the art. In addition, it will be understood by those skilled in the art that various modifications are possible as long as the technical spirit of the present invention is included.

Hereinafter, the present invention will be described in more detail by explaining preferred embodiments of the present invention. However, the present invention is not limited to the following examples, and various forms of embodiments can be implemented within the scope of the appended claims, and the following examples are only common to those skilled in the art to complete the present disclosure. It is intended to facilitate the implementation of the invention to those with knowledge.

Example 1

First, the aloe powder (Martin Bauer, France) was concentrated with ethanol (alcohol) while 750 g of various cyclic pellet seeds having a particle size of 500 to 850 µm were flowed in a fluidized bed granulator (Glatt GPCG-1). Solid amount: 900g) was coated with aloe layer by the bottom spray method, and 24.75g of the primary coating film shellac was dissolved in 300.0g of anhydrous ethanol for the purpose of concealing the bitter taste and coated by the bottom spray method, 33.0g of the secondary coating film ethyl cellulose, dioxide 3.3 g of silicon was dissolved in a mixture of 238.0 g of ethanol and 92.0 g of purified water, and coated with a bottom spray method to obtain a product in which bitter taste was concealed. The formulation had an aloe extract content of about 51% by weight.

Example 2

As in Example 1, aloe powder (French Martin Bauer) was concentrated in ethanol (alcohol) while 750 g of white sugar mixed pellet seed having a particle size of 500 to 850 µm was flowed in a fluidized bed granulator (Glatt GPCG-1). The aloe layer (solid weight: 900 g) was coated with a layer of aloe by spraying the bottom, and 33.0 g of ethyl cellulose and 3.3 g of silicon dioxide were mixed with a 238.0 g of ethanol and 92.0 g of purified water as a primary coating film for the purpose of concealing bitter taste. It melt | dissolved, it coated by the bottom spray method, 24.75g of shellac was melt | dissolved in 300.0g of anhydrous ethanol by the secondary coating film, and it coated by the bottom spray method, and obtained the product which concealed the bitter taste.

In the case of Example 2, it was observed that the surface of the final product is unevenly formed by affecting the ethyl cellulose coating film of the primary coating film by ethanol used as the solvent of the shellac in the process of coating the secondary coating film shellac, In contrast with 1, it was found to be undesirable.

Example 3

As in Example 1, aloe powder (French Martin Bauer) was concentrated with ethanol (alcohol) while 700 g of a circular sugar pellet seed having a particle size of 200 to 350 µm was flowed in a fluidized bed granulator (Glatt GPCG-1). The aloe layer (solid weight: 1000 g) was coated with an aloe layer by the bottom spray method, and 24.75 g of the primary coating film shellac was dissolved in 300.0 g of anhydrous ethanol for the purpose of concealing the bitter taste, and then coated by the bottom spray method, and the second coating film ethylcellulose 33.0 g and 3.3 g of silicon dioxide were dissolved in a mixture of 238.0 g of ethanol and 92.0 g of purified water, and the resultant was coated by a bottom spraying method to obtain a product that concealed bitter taste. The formulation had an aloe extract content of about 55% by weight.

Example 4

In Example 4, in the preparation of Example 1, in particular, in the step of forming a layer of aloe extract on the saccharide pellets seeded with sugar, B. longum in the bifidus bacteria was added to the aloe extract at 10 ⁷ to 10 ¹⁰ grains / g. After the formation of the formulation was carried out in the same manner as in Example 1.

Example 5

In Example 5, in the preparation of Example 1, L. acidophilus in lactic acid bacilli was added to the aloe extract in a step of forming a layer of aloe extract in the circumferential ring-shaped pellet seed, 10 ⁷ ~ 10 ¹⁰ / g. After the formation of the formulation was carried out in the same manner as in Example 1.

Comparative Example 1

In Comparative Example 1, unlike the above examples, the first seed was not cyclic pellet of white sugar, but 850 g of aloe powder was seeded, and about 5% by weight of shellac (50 g) was used as a secondary coating. 10 wt% (100 g) of cellulose was coated by the bottom spray method while flowing in a fluidized bed granulator (Glatt GPCG-1) to obtain a product. Considering that the formulation is about 85% by weight of the aloe powder itself, the aloe content is about 60% by weight, but it has been found that it does not conceal the bitter taste of aloe.

In the case of Comparative Example 1, it is thought that more than about 30% by weight of the coating base amount is required.

Comparative Example 2

600 g of aloe powder as a seed, coated with about 30% by weight of hardened oil (300 g), and about 10% by weight (100 g) of ethyl cellulose were coated by a bottom spray method while flowing in a fluidized bed granulator (Glatt GPCG-1). The product was obtained. Considering that the content of the aloe powder itself of the formulation is about 60% by weight, the aloe content is about 42% by weight, but it has been found that it does not conceal the bitter taste of aloe.

[Test Example 1]

The formulations of Examples 1 to 3 and Comparative Examples according to the present invention were carried out in a buffer according to the following method to determine the amount of aloe eluted with time. 3 is a graph showing the extract dissolution rate with time of the coated formulation according to Examples 1 to 3 and Comparative Examples of the present invention.

The measurement was performed in accordance with the second dissolution test method of the Korean Pharmacopoeia, 900 mL (0.166 mg / ml) of PBS buffer solution at pH 7.0 by weighing the corresponding amount of 10 mg of aloe for each preparation. , 100 rpm / min, 37 ± 0.5 ° C.

After the start of the dissolution experiment, a certain amount was taken over time, filtered through a 0.45 μm filter and analyzed by measuring the absorbance with a UV-VIS spectrometer. UV detection wavelength was 512 nm which shows the maximum absorption band.

As shown in Figure 3, the formulations of Examples 1 to 3 according to the present invention can be confirmed that the release almost occurs in the initial 5 minutes showing the bitter taste is released within 90 minutes, while the comparative example From the early days, aloe was released, and I could not help but feel the bitter taste in my mouth.

[Test Example 2]

After the tasting of 10 trained professional panelists, the sensory tests of the formulations of Examples 1-3 and the formulations of Comparative Examples were carried out using a 9-point scale (the larger the degree, the closer to 9).

bitter Outlier Overall harmony Example 1 2.1 1.6 6.9 Example 2 3.1 2.9 5.9 Example 3 2.5 2.3 5.5 Comparative Example 1 6.5 3.2 3.2 Comparative Example 2 4.5 4.5 4.1

As shown in Table 1, the formulations of Examples 1 to 3 according to the present invention were found to be more effective in concealing the bitter taste of aloe than in the comparative examples to facilitate the administration to the subject.

[Test Example 3]

Using the formulation of Example 1 and the formulation of Example 4 containing the lactic acid bacteria as a test sample, the effects on the improvement of constipation symptoms and the like were evaluated.

The evaluation items included improvement of constipation symptoms, increase and decrease in the number of bowel movements, the degree of residual feeling, the taste of the product, the presence or absence of symptomatic symptoms, the ease of defecation, the timing of effect manifestation, the satisfaction of the efficacy, and the ease of taking. . The evaluation method was performed as follows.

The experiment was performed on 59 women in their 20s and 40s with constipation. After grouping two groups of similar conditions according to age and degree of constipation symptoms, the formulation of Example 1 and the formulation of Example 4 were provided for each group.

A questionnaire was conducted for each item classified into five categories of improvement of constipation symptoms. Table 2 below shows the test results regarding the degree of improvement in constipation symptoms.

division                                              First group: providing the formulation of Example 1 Group 2: providing the formulation of Example 4 Improvement of constipation symptoms (unit: number of people selected)                                              Very improved (5 points) 6 7 Some improvement (four points) 24 15 No change (3 points) 4 3 A little worse (two points) Very bad (1 point) 5-point scale comparison 4.06 4.16

4 is a graph showing the degree of improvement of constipation in comparison with the evaluation results by the five-point scale method of the formulation of Example 1 and the formulation of Example 4 containing lactic acid bacteria.

As can be seen from Table 2 and Figure 4, compared with the case of Example 1 containing only aloe, the case of Example 4 containing lactic acid bacteria was found to have a somewhat high evaluation in the degree of improvement in constipation symptoms.

In addition, in this Test Example 3, a questionnaire was conducted regarding each item classified into five kinds of increase and decrease of bowel movements, and the average value of scores by the five-point scale method was compared with the number of people (selection number) of each group that selected the item. It was. Table 3 below shows the test results regarding the degree of change in the number of bowel movements.

division                                              First group: providing the formulation of Example 1 Group 2: providing the formulation of Example 4 Number of defecation changes (unit: number of people selected) Very high (5 points) 3 6 A little increase (four points) 19 14 No change (3 points) 12 5 A little decrease (two points) Very low (one point) 5-point scale comparison 3.74 4.04

FIG. 5 is a graph showing the evaluation results by the 5-point scale method of the formulation of Example 1 and the formulation of Example 4 containing lactic acid bacteria with respect to the degree of change in bowel movement.

As can be seen from Table 3 and Figure 5, compared with the case of Example 1 containing only aloe, the case of Example 4 containing lactic acid bacteria was shown to have a greater degree of increase in the number of bowel movements.

In addition, in this Test Example 3, a questionnaire was conducted regarding each item classified into five kinds of increase and decrease of the residual amount, and the number of people (selection number) of each group that selected the item was evaluated. Table 4 below shows the test results regarding the degree of increase and decrease of residual feeling.

division                                              First group: providing the formulation of Example 1 Group 2: providing the formulation of Example 4 Residual amount (unit: number of people selected) Very increased Little increase 3 No change 6 7 Little decrease 21 15 Very reduced 4 3

As can be seen from Table 4, the case of Example 1 containing only aloe and the case of Example 4 containing lactic acid bacteria were evaluated to be similar in the residual feeling.

In addition, in this Test Example 3, a questionnaire was conducted for each item classified into five kinds of taste satisfaction of the product, and the average value of the number of people (selection number) and the score by the five-point scale method of each group that selected the item was selected. Compared. Table 5 below shows the test results regarding the satisfaction of product taste.

division                                              First group: providing the formulation of Example 1 Group 2: providing the formulation of Example 4 Taste of the product (unit: number of people selected) Very satisfied (five points) 5 8 Some satisfaction (four points) 13 5 Normal (three points) 10 9 Some dissatisfaction (two points) 5 2 Very dissatisfied (1 point) One One 5-point scale comparison 3.47 3.68

FIG. 6 is a graph showing the results of evaluation by the 5-point scale method of the formulation of Example 1 and the formulation of Example 4 containing lactic acid bacteria with respect to the satisfaction of product taste. FIG.

As can be seen from Table 5 and Figure 6, compared with the case of Example 1 containing only aloe, the case of Example 4 containing lactic acid bacteria was found to have a better evaluation in the satisfaction of the taste of the product.

In addition, in this Test Example 3, a questionnaire was conducted regarding each item classified into five levels of ease of bowel movement, and the number of people (selection number) of each group who selected the item was compared with the average value of the score by the 5-point scale method. It was. Table 6 below shows the test results on the degree of ease of bowel movement.

division                                              First group: providing the formulation of Example 1 Group 2: providing the formulation of Example 4 Ease of defecation (unit: number of people selected) Very soft (five points) 7 8 Somewhat soft (four points) 25 12 No change (3 points) 2 5 A little difficulty (two points) Very difficult (1 point) 5-point scale comparison 4.15 4.12

FIG. 7 is a graph showing the evaluation results by the 5-point scale method of the formulation of Example 1 and the formulation of Example 4 containing lactic acid bacteria with respect to the degree of ease of bowel movement.

As can be seen from Table 6 and Figure 7, in the ease of bowel movement, compared to the case of Example 1 containing only aloe, the case of Example 4 containing lactic acid bacteria showed a slightly smaller but almost similar score.

In addition, in this Test Example 3, a questionnaire was conducted regarding each item classified into five kinds of effect expression time, and the number of people (selection number) of each group that selected the item was compared with the average value of the score by the 5-point scale method. Table 7 below shows the test results regarding the timing of effect expression.

division                                              First group: providing the formulation of Example 1 Group 2: providing the formulation of Example 4 Timing of Effect Immediately (5 points) One Within 5 hours (4 points) 5 5 Within 10 hours (3 points) 22 8 Within 2-3 days (2 points) 4 8 Within 1 week (1 point) One 5-point scale comparison 2.88 2.64

8 is a graph showing the results of evaluation by the 5-point scale method of the formulation of Example 1 and the formulation of Example 4 containing lactic acid bacteria with respect to the timing of effect expression.

As can be seen from Table 7 and Figure 8, in contrast to the case of Example 1 containing only aloe, the case of Example 4 containing lactic acid bacteria was slightly lower in the time of effect expression, but it can be seen that it was evaluated to a similar degree there was.

In addition, in this Test Example 3, a questionnaire was conducted for each item classified into five types of satisfaction satisfaction, and the average value of scores by the five-point scale method was compared with the number of people (selection number) of each group that selected the item. Table 8 below shows the test results regarding the satisfaction of efficacy.

division                                              First group: providing the formulation of Example 1 Group 2: providing the formulation of Example 4 Satisfaction of efficacy Very satisfied (five points) 7 8 Some satisfaction (four points) 14 6 Normal (three points) 11 5 Some dissatisfaction (two points) One 5 Very dissatisfied (1 point) One One 5-point scale comparison 3.74 3.6

9 is a graph showing the results of evaluation by the five-point scale method of the formulation of Example 1 and the formulation of Example 4 containing lactic acid bacteria with respect to the satisfaction of efficacy.

As can be seen from Table 8 and Figure 9, in contrast to the case of Example 1 containing only aloe, it was found that the case of Example 4 containing lactic acid bacteria was evaluated as a similar degree, although slightly less in the satisfaction of efficacy.

In addition, in this Test Example 3, a questionnaire was conducted for each item classified into five types of ease of taking, and the average value of scores by the five-point scale method was compared with the number of people (selection number) of each group that selected the item. Table 9 below shows the test results regarding the ease of taking.

division                                              First group: providing the formulation of Example 1 Group 2: providing the formulation of Example 4 Ease of taking Very convenient (5 points) 7 5 A little convenience (four points) 6 11 Normal (three points) 11 4 A little uncomfortable (2 points) 8 5 Very uncomfortable (1 point) 2 5-point scale comparison 3.24 3.65

10 is a graph showing the preparation of Example 1 and the preparation of Example 4 containing lactic acid bacteria in terms of ease of taking.

As can be seen from Table 9 and FIG. 10, it was found that the case of Example 4 containing lactic acid bacteria was evaluated as superior in the ease of taking, as compared with the case of Example 1 containing only aloe.

In addition, in this Test Example 3, a questionnaire about the presence or absence of symptom of the stomach pain and the presence of other symptoms was conducted. The number of people in each group who selected the item was compared. Table 10 below shows the test results for the presence or absence of embryonic symptoms and the presence of other symptoms.

division                                              First group: providing the formulation of Example 1 Group 2: providing the formulation of Example 4 Embryo symptoms (unit: number of people selected) has exist 18 11 none 16 12 Other symptoms (swollenness, minor headache) -2 (two people in group 1 complain of different symptoms) -2 (two people in group 2 complain of different symptoms)

As described above, when lactic acid bacteria were added to the aloe extract, which is a plant extract, it was effective in improving constipation symptoms and increasing the number of bowel movements, and further, in terms of ease of taking and taste of the product.

The plant extract-containing preparation according to the present invention and a method for preparing the same, unlike the prior art, coating the concentrate of the plant extract, in particular, the aloe extract or green tea extract on the pellet seed, in particular, the pellet seed of white sugar or microcrystalline cellulose, the coating film, In particular, by forming a double coating film, it effectively masks the unpleasant taste of the plant extract, especially the bitter taste of the aloe extract or the astringent taste of the green tea extract, and thus concealed so as to be suitable for consumer use of the product, while the content of the extract To achieve the effect. Furthermore, the method for producing a coated formulation that hides the unpleasant taste of the plant extract according to the present invention achieves the effect that the production process is particularly simplified compared to the prior art to increase production efficiency.

In addition, the plant extract-containing preparation according to the present invention and a method for producing the same, it is easy to adjust the dissolution pattern of the extract by the coating amount of the coating agent, free selection of the final particle size by a simple operation in the manufacturing process, The appearance of the final product is excellent, and well mixed with excipients, such as a plant extract, especially aloe extract or green tea extract is very suitable for use as a dietary supplement or medicine.

In particular, the plant extract containing the preparation according to the present invention has an excellent effect in improving constipation, such as improving constipation symptoms, increased bowel recovery by containing lactic acid bacteria in particular.

Although the present invention has been described in connection with the above-mentioned preferred embodiments, it is possible to make various modifications or variations without departing from the spirit and scope of the invention. Accordingly, the appended claims will cover such modifications and variations as fall within the spirit of the invention.

Claims (21)

Pellet seed (1); A first coating layer (2) of concentrated plant extract formed on the seed (1); 2-1 coating layer (3) of shellac or cellulose-based coating base formed on the coating layer (2); And In the shell comprising a shellac or cellulose-based coating 2-2 coating layer (4) formed on the 2-1 coating layer (3), the 2-1 coating layer 3 and the 2-2 coating layer (4) is a formulation containing a plant extract, characterized in that the different coating base. delete The method of claim 1, The second-1 coating layer 3 is a coating layer of shellac; The second-2 coating layer 4 is a coating layer of a cellulose-based coating base; The second-2 coating layer (4) is a formulation containing a plant extract, characterized in that it further comprises silicon dioxide. The method of claim 3, wherein the formulation is Formulations containing a plant extract, characterized in that the particle size of the formulation is 300 to 1000㎛. The method of claim 3, wherein the pellet seed (1), A formulation containing a plant extract, characterized by consisting of white sugar or microcrystalline cellulose. The method of claim 5, wherein the pellet seed (1), Formulations containing a plant extract, characterized in that the pellet seed of 200 to 800㎛. The method of claim 3, wherein the concentrated plant extract, A formulation containing a plant extract, characterized in that the concentrated aloe extract or concentrated green tea extract. The method of claim 3, wherein the cellulose-based coating base, A formulation containing a plant extract, characterized in that at least one selected from the group consisting of methyl cellulose, ethyl cellulose and hydroxypropyl methyl cellulose. The method of claim 5, wherein the formulation, 10 to 70 parts by weight of the white sugar or microcrystalline cellulose; 10 to 90 parts by weight of the concentrated plant extract; 0.1 to 5 parts by weight of the shellac; 0.1 to 2 parts by weight of the silicon dioxide; And Formulation containing a plant extract, characterized in that consisting of; 1.0 to 10 parts by weight of the cellulose-based coating base. The method of claim 9, wherein the formulation, Formulation containing a plant extract, characterized in that the weight ratio of the concentrated plant extract and white sugar or microcrystalline cellulose is 1: 4 to 4: 1. The method of claim 3, wherein the formulation is Plants characterized in that they are formulated with at least one selected from the group consisting of pharmaceutically acceptable carriers, excipients, binders, disintegrants, solubilizers, suspending agents, preservatives and weighting agents for use in the dietary supplements or pharmaceuticals. Formulations containing extracts. The method according to any one of claims 1 or 3 to 11, The plant extract is a formulation containing a plant extract, characterized in that it further comprises lactic acid bacteria. The method of claim 12, The formulation is a formulation containing a plant extract, characterized in that used for improving constipation. The method according to claim 1 or 3 to 11, wherein the formulation is The plant extract is a concentrated aloe extract, containing a plant extract, characterized in that it is used for improving constipation. Coating the concentrated plant extract on the pellet seed 1 to form a first coating layer 2 (S1); Coating a shellac or cellulose-based coating base dissolved in a solvent on the first coating layer 2 to form a second coating layer 3 (S2); and In the coating of the shellac or cellulosic coating base, dissolved in a solvent on the 2-1st coating layer 3, to form a 2-2 coating layer (4), the second -1 coating layer (3) and the second-second coating layer (4) is a method for producing a formulation containing a plant extract, characterized in that the different coating base. delete The method of claim 15, The step S2 is a step of forming a second-first coating layer 3 by coating shellac, dissolved in a solvent, on the first coating layer 2; Step S3 is a step of forming a second-2 coating layer 4 by coating a cellulose-based coating base dissolved in a solvent on the second-1 coating layer 3; The step S3 is a method for producing a formulation containing a plant extract, characterized in that the cellulosic coating base is dissolved in a solvent together with silicon dioxide. The method of claim 17, wherein the step S1, A method for producing a formulation containing a plant extract, characterized by using white sugar or microcrystalline cellulose as the pellet seed (1). The method of claim 17, wherein the step S1, As a concentrated plant extract, the aloe powder concentrate prepared by dissolving aloe powder in ethanol (alcohol) or the green tea powder concentrate prepared by dissolving green tea powder in ethanol (liquor) is used. Manufacturing method. The method of claim 17, wherein the step S1, A method for producing a formulation containing a plant extract, characterized in that at least one selected from the group consisting of methyl cellulose, ethyl cellulose and hydroxypropyl methyl cellulose is used as the cellulosic coating base. The method according to any one of claims 15 or 17 to 20, The step S1 is a method for producing a formulation containing a plant extract, characterized in that further adding lactic acid bacteria to the plant extract.

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