CN105007949B - Coated composition, coated preparation and its manufacturing method - Google Patents

Abstract

The invention provides a coating composition and a coating preparation coated with the coating composition. By containing (A) alginate and (B) plasticizer, the coating composition does not dissolve in the stomach but dissolves in the intestinal tract, so that the coated active ingredient and the like can reach the intestinal tract without Chipping and falling off occurred, and coating was possible uniformly, and the coating property was excellent.

Description

Coating composition, coating preparation and production method thereof

technical field

The present invention relates to a coating composition used for coating food, pharmaceuticals, etc., a coating preparation, and a production method thereof.

Background technique

Enteric-coated preparations are required that have functional ingredients such as proteins such as lactic acid bacteria and enzymes, maintain their structure by preventing decomposition in the stomach, and allow them to reach the intestinal tract to exert high functional active ingredients. Dissolve and dissolve in the intestinal tract, so that the active ingredient can reach the intestinal tract.

As a protective film for the active ingredient to reach the intestinal tract, there are generally ingredients that do not dissolve under the pH conditions (acidic) in the stomach but dissolve under the pH conditions (neutral to alkaline) of the small intestine, such as methacrylic acid-based high Molecular compounds, shellac, zein, etc.

However, methacrylic polymers are limited to pharmaceutical applications and cannot be used in food. On the other hand, although shellac and zein can also be used for food purposes, they are generally sprayed with organic solvents. Even for food use, it is desired to utilize water-soluble film preparations that can be coated with water in consideration of the environment.

prior art literature

patent documents

Patent Document 1: Japanese Patent Laid-Open No. 2002-193792

Contents of the invention

The problem to be solved by the invention

The purpose of the present invention is to provide a coating composition, a coating preparation coated with the coating composition and a production method thereof. The coating composition does not dissolve in the stomach but dissolves in the intestinal tract, which can make the The coating material, such as the active ingredient of the coating, reaches the intestinal tract, and can be coated uniformly without chipping or falling off, and the coating property is excellent.

means of solving problems

The present inventors found that the coating composition containing alginate and a plasticizer does not dissolve in the stomach but dissolves in the intestinal tract, allowing the coated objects such as active ingredients to reach the intestinal tract, and has excellent coating properties, thereby completing the present invention. invention.

Therefore, the present invention provides the following inventions.

[1]. A coating composition comprising (A) an alginate and (B) a plasticizer.

[2]. The coating composition according to [1], wherein the component (A) is an alginate selected from the group consisting of sodium alginate, potassium alginate, and ammonium alginate.

[3]. The coating composition according to [1] or [2], wherein the component (A) is an alginate (A-1) whose viscosity at 20° C. exceeds 50 mPa·s in a 1% by mass aqueous solution.

[4]. The coating composition according to [1] or [2], wherein the component (A) is an alginate (A-1) whose viscosity at 20° C. exceeds 50 mPa·s in a 1% by mass aqueous solution, and An alginate (A-2) having a viscosity of 50 mPa·s or less in a 1 mass % aqueous solution at 20°C.

[5]. The coating composition according to any one of [1] to [4], which further contains (C) selected from gelatin, pectin, curdlan, pullulan, acacia gum, yellow Ingredients of raw gum, gellan gum, hydroxypropyl methylcellulose, sodium carboxymethylcellulose and hydroxypropyl cellulose.

[6]. The coating composition according to any one of [1] to [5], further comprising (D) fine particles.

[7]. The coating composition according to any one of [1] to [6], wherein the component (B) is glycerin and/or sucrose fatty acid ester.

[8]. The coating composition according to any one of [1] to [7], wherein the content mass ratio represented by (A):(C) is 1:10 to 20:1.

[9]. A coated preparation having a coating film formed from the coating composition according to any one of [1] to [8].

[10]. The enteric coating preparation according to [9], which is an enteric coating preparation in which the coating film is enteric.

[11]. A method for producing a coating preparation, comprising the steps of: spraying a coating solution containing the coating composition according to any one of [1] to [8] and water on an object to be coated, and drying , thereby forming a coating film on the surface of the coated object.

The effect of the invention

The present invention can provide a coating composition, a coating preparation coated with the coating composition and a production method thereof. The coating composition does not dissolve in the stomach but dissolves in the intestinal tract, so that the effectively coated The ingredients reach the intestinal tract and are excellent in coating properties.

Description of drawings

Fig. 1 is a graph showing the results of test examples.

Detailed ways

Next, the present invention will be described in detail.

(1) coating composition

The coating composition of the present invention contains (A) alginate and (B) plasticizer.

(A) Alginate

The alginate is preferably a monovalent alginate such as sodium salt, potassium salt, ammonium salt, or a water-soluble salt of alginic acid. Examples of the alginate include (A-1) an alginate having a viscosity of 1% by mass aqueous solution at 20°C exceeding 50 mPa·s, and (A-2) a viscosity of 1% by mass aqueous solution at 20°C of 50 mPa·s or less Alginate can be used alone or in combination of two or more.

(A-1) Alginate having a viscosity of 1% by mass aqueous solution at 20° C. exceeding 50 mPa·s, preferably exceeding 50 mPa·s and 600 mPa·s or less, more preferably exceeding 50 mPa·s and 400 mPa·s or less Alginate.

(A-2) An alginate having a 1% by mass aqueous solution having a viscosity of 50 mPa·s or less at 20°C is preferably 5 to 50 mPa·s, more preferably 10 to 50 mPa·s. (A-2) The alginate is preferably sodium alginate.

With respect to the coating composition, the compounding amount of (A) component is preferably 5 to 85% by mass (solid matter: when described as solid matter below, it is the ratio to the total amount of components after the solvent is removed, and the coating film in the same proportion.). The range of 10-80 mass % (solid matter) is more preferable, The range of 10-70 mass % (solid matter) is still more preferable, The range of 10-60 mass % (solid matter) is still more preferable.

When mixing (A-1) alginate, the mixing amount is preferably 5 to 85% by mass (solid content), more preferably 10 to 60% by mass (solid content), and still more preferably 20 to 50% by mass based on the coating composition. Mass % (solids) range. More enteric solubility can be obtained by being more than the said range. When it is below the said range, sticking and peeling at the time of coating can be prevented and favorable coating performance can be obtained.

When mixing (A-2) alginate, the mixing amount is preferably 85% by mass (solid content) or less, more preferably 5 to 50% by mass (solid content), and still more preferably 10 to 40% by mass based on the coating composition % (solids) range. When it is more than the said range, enteric-soluble property improves, and coating property becomes favorable.

In the present invention, it is preferable to use (A-1) alginate as (A) alginate. By using such an alginate of a certain length or more, the coating property is good, and high acid resistance can be imparted to the formed coating film. In addition, by using the alginate (A-1) and the alginate (A-2) in combination, the coating performance can be further improved while maintaining enteric solubility.

The use of two types of alginate with different viscosities, such as the above-mentioned (A-1) alginate and (A-2) alginate, is not only from the viewpoint of adjusting the viscosity of the coating solution but from the viewpoint of enteric solubility and coating properties. Choose from two alginates. The mass ratio (A-1):(A-2)((A-1)/(A-2)) is preferably 1:5 to 10:1 (0.2 to 10), more preferably 1:3 to 5:1 (0.33-5), more preferably 1:1.8-3:1 (0.56-3). By being more than the lower limit, the performance of the film under acidification is higher, so that the inelution property is favorable. By being below the upper limit, coatability becomes better.

In addition, in this invention, the viscosity measurement of the alginate was performed using the rotational viscometer (BM type). Use spindle No.1 for viscosities less than 200mPa·s, and spindle No.2 for viscosities above 200mPa·s and less than 1,000mPa·s, measure 1% by mass aqueous solution at 20°C and 30rpm, and take the value after 60 seconds as a measured value.

The viscosity of alginate is roughly proportional to the molecular weight of alginate. For example, the weight average molecular weight (Mw) of the above (A-1) is 800,000 or more, preferably 800,000 to less than 3 million, and more preferably 800,000 to less than 1,900,000. (A-2) has a weight average molecular weight (Mw) of 200,000 to less than 800,000, preferably 300,000 to less than 800,000. In addition, the gel chromatography measurement method of the weight average molecular weight (Mw) of the alginate of this invention is as follows.

(1) Sample preparation

Alginate was dissolved in a mobile phase (0.1M (mol/L) NaNO ₃ aqueous solution) so that the concentration of alginate was 0.1% by mass, and this was used as a sample.

Calibration curves were prepared using standards of various molecular weights (pullulan: Mw=1.66 million, Mw=380,000, Mw=100,000, Mw=12,200, dissolved in the mobile phase at a concentration of 0.1% by mass).

(2) GPC measurement conditions

Chromatographic column: Shodex OHpak SB-806M HQ (8mmI.D.×300mmL., 13μm)

Mobile phase: 0.1M (mol/L) NaNO ₃ aqueous solution

Flow: 0.5mL/min

Temperature: 40°C

Injection volume: 200μL (0.1% in mobile phase)

Detector: Differential Refractive Index (RI) detector

(3) Analysis method

Obtain the standard curve formula through the standard curve sample, and obtain the weight average molecular weight (Mw) converted into pullulan according to the GPC analysis result of the sample.

(B) Plasticizer

Plasticizers include surfactants such as sucrose fatty acid esters, glycerin fatty acid esters, monoglycerin fatty acid esters, and polyoxyethylene sorbitan fatty acid esters; polyalcohols such as glycerin, propylene glycol, and polyethylene glycol; glucose, Sugars such as fructose syrup and sucrose; sugar alcohols such as sorbitol, maltitol, mannitol, erythritol, and xylitol; dodecyl alcohol, tridecyl alcohol, myristyl alcohol, pentadecyl alcohol , Cetyl Alcohol, Heptadecanol, Stearyl Alcohol, Cetyl Alcohol, Isostearyl Alcohol, 2-octyldodecanol and other higher alcohols (suitable for carbon number 6-22); Fatty acid esters (preferably having 6 to 12 carbon atoms) and other fats and oils. These can be used individually by 1 type or in appropriate combination of 2 or more types. Among these, glycerin is preferable from the viewpoint of the plasticizing effect of the coating film, surfactants are preferable from the viewpoint of enteric solubility, and glycerin and/or sucrose fatty acid ester are more preferable.

The compounding quantity of (B) component is preferably 0.1-70 mass % (solid matter) with respect to a coating composition, More preferably, it is 2-50 mass % (solid matter). When it is more than the above range, film peeling during coating can be further suppressed, and when it is less than the above range, stickiness during coating can be suppressed, coating treatment becomes easier, and good enteric solubility can be obtained.

The mass ratio represented by (B)/(A) is preferably in the range of 0.05 to 3.0, more preferably 0.1 to 2.0, still more preferably 0.15 to 1.5, particularly preferably 0.15 to 1.1. When it is within the above range, the film performance under acidification becomes higher, and when it is below the upper limit, coating property becomes better.

Film-forming components other than (A) may be mixed in the coating composition of the present invention. (C) The film-forming component includes gelatin, pectin, curdlan, pullulan, gum arabic, xanthan gum, gellan gum, hydroxypropylmethylcellulose, sodium carboxymethylcellulose, Hydroxypropyl cellulose, agar, chitosan, tamarind gum, locust bean gum, polyvinyl alcohol, ethyl cellulose aqueous dispersion, etc. These can be used individually by 1 type or in appropriate combination of 2 or more types. Among them, gelatin, pectin, curdlan, pullulan, gum arabic, xanthan gum, gellan gum, hypromellose, etc. are preferably selected from the viewpoint of coating properties and combination with component (A). cellulose, sodium carboxymethylcellulose and hydroxypropylcellulose.

At this time, the mass ratio represented by (A):(C)((A)/(C)) is preferably 1:10 to 20:1 (0.1 to 20), more preferably 1:5 to 20:1 (0.2 to 20), more preferably 1:1 to 10:1 (1 to 10). Within this range, it is possible to obtain a tablet excellent in enteric coating performance, which has a higher film performance under acidic conditions, while maintaining coating properties and good appearance.

The mixing amount of the (C) component is preferably 1 to 90% by mass (solid matter), more preferably 5 to 80% by mass (solid matter), and still more preferably 10 to 80% by mass (solid matter) based on the coating composition. By being more than the above-mentioned range, the effect of compounding (C)component can be acquired more, and if it exceeds the said range and it mixes, it may affect enteric solubility.

(D) Microparticles may also be mixed in the coating composition. By mixing fine particles, it is possible to prevent the peeling of the coating film due to the adhesion of the tablets to each other during the coating process. (D) Components include, for example, talc powder, calcium stearate, silicon dioxide, titanium oxide, etc., and may be used alone or in combination of two or more. The particle size of the fine particles is 0.01 to 50 μm, preferably 0.1 to 20 μm. In addition, the measurement of particle diameter was performed using the laser diffraction type particle size distribution analyzer (dry type measurement).

The compounding quantity of (D)component is preferable with respect to a coating composition, 1-80 mass % (solid matter), More preferably, it is 3-60 mass % (solid matter), More preferably, it is 5-40 mass % (solid matter). By being more than the above-mentioned range, the effect of mixing the above-mentioned (D) component can be obtained better, and if it mix|blends exceeding the said range, it may affect film-forming property.

In addition, it is preferable not to contain divalent metal ions such as copper ions, barium ions, and calcium ions in the coating composition. Since alginate is gelled by cross-linking through these ions, the coating property is deteriorated. That is to say, in the case of reacting monovalent alginate with divalent cations to crosslink it, although the dried film is water-insoluble, since the viscosity of the gelation becomes too high, the spray of fine liquid And the extensibility on the tablet becomes difficult. As a result, it becomes difficult to form a uniform film, and the appearance deteriorates, and in addition, the dissolution property may not be stable. The permissible range of the divalent metal ion is preferably 0.25 mol or less, more preferably 0.1 mol or less, per 1 mol of the alginate monomer.

In the coating composition of the present invention, in addition to the above-mentioned components (A) to (D), components commonly used in coating compositions may be used singly or mixed in appropriate amounts of two or more. As such an arbitrary function, an antifoaming agent, a coloring agent, etc. are mentioned.

Examples of antifoaming agents include glycerin fatty acid esters, dimethylpolysiloxane, dimethylpolysiloxane-silica mixture, hydrous silica, silica, etc., and can be used alone or in combination Use two or more.

Examples of coloring agents include catechin tannic acid powder, turmeric extract, yellow ferric oxide, orange essence, brown iron oxide, carbon black, caramel, carmine, carotene liquid, β-carotene, and licorice extract , gold foil, black iron oxide, light silicic anhydride, titanium oxide, ferric oxide, edible blue No. 1, edible yellow No. 4, edible yellow No. 4 aluminum lake, edible yellow No. 5, edible red No. 2, edible Red No. 3, Edible Red No. 102, sodium hydroxide, sodium copper chlorophyllin, copper chlorophyllin, barley green leaf extract, medicinal charcoal, riboflavin butyrate, riboflavin, green tea powder, riboflavin sodium phosphate, etc.

The coating composition of the present invention may contain organic solvents such as water and ethanol within the range not impairing the effects of the present invention. The mixing amount of the solvent in the coating composition is suitably selected within the range of 1 to 98% by mass, preferably 50 to 98% by mass, more preferably 70 to 96% by mass, based on the entire coating composition.

(II) Coating preparation

Using the above-mentioned coating composition, a coating film of the coating composition can be formed on an object to be coated to obtain a coating preparation.

The coating film formed from the coating composition of the present invention contains the above-mentioned (A) component, but as described later, the alginic acid aqueous solution is directly dried to form a water-soluble film. This water-soluble film has the characteristic that under acidic conditions, monovalent cations are substituted with hydrogen ions to form alginic acid to form an insoluble film, which is further dissolved under neutral to alkaline conditions.

The coating composition of the present invention and the coating film formed by the coating composition are enteric, that is, they have the property of "not dissolving in the stomach but dissolving in the intestinal tract, enabling the coated article to reach the intestinal tract". An enteric coating preparation in which the coating film is enteric was obtained.

"Enteric" in the present invention refers to a preparation that allows functional ingredients to reach the intestinal tract. It means that the test is carried out according to the dissolution test method of the Japanese Pharmacopoeia, and the dissolution rate is less than 50% (suitably below 30%) in the dissolution test solution (pH 1.2) equivalent to gastric juice, and the dissolution rate is less than 30% in the equivalent intestinal juice. The dissolution rate in the test solution (pH 6.8) was over 70% in 2 hours.

The shape and dosage form of the article to be coated are not particularly limited, and are not particularly limited to tablets, powders, fine granules, granules and the like. Tablets can be single-layered or more than two-layered. Among them, tablets are preferable from the viewpoint of better exhibiting enteric solubility. The size of the tablet is not particularly limited, and from the viewpoint of easy handling and swallowability of the tablet, the diameter of the tablet is preferably more preferred In addition, the mass of each tablet is suitably about 150 to 700 mg.

The thickness of the coating film is not particularly limited, but is preferably 5 μm to 1 mm, more preferably 10 to 500 μm. In addition, in the case of a tablet, the coating film is preferably 0.5 to 20% by mass, more preferably 1 to 15% by mass, based on the coating preparation. In the case of granules, powders, and powders, it is preferably 10 to 60% by mass, more preferably 15 to 50% by mass. In addition, the content (solid content) of each of the above-mentioned components in the coating film is the same as that of the above-mentioned coating composition.

The article to be coated is not particularly limited, and examples thereof include active ingredients such as foods and pharmaceuticals. Examples include proteins such as lactic acid bacteria, cystine, iron, antibodies, and lactoferrin, peptides, and ATP-2Na, and these may be used alone or in combination of two or more. Among them, high molecular weight components such as protein and water-insoluble components are preferable.

(III) Manufacturing method of coating preparation

The coating composition can be obtained by mixing the above-mentioned necessary components, and the coating preparation can be obtained by the following method: directly spray the coating composition to the object to be coated, or spray the coating solution added with water, and dry it before being coated. A coating film is formed on the surface of the clothing. The coating composition of the present invention is aqueous, so it can be coated with water to form a water-soluble film.

The coating solution contains the coating composition and water, and the water content of the coating solution is preferably 50 to 98% by mass, more preferably 70 to 96% by mass. Moreover, organic solvents, such as ethanol, can also be mixed in the range which does not impair the effect of this invention.

The coating machine is not particularly limited, and a pan coating machine (pancoating machine), a fluidized bed coating machine, a drum coating machine, etc. can be used.

The coating method is not particularly limited, and examples thereof include a method in which the surface of the object to be coated is formed into a film by spraying a coating solution on the object to be coated, followed by heating and drying. The coating solution can be heated appropriately, the temperature is preferably 30-80°C, and the drying temperature is preferably 40-80°C. The rate of adding the coating solution is preferably 1 to 5 g/min with respect to a drying air volume of 1 m ³ /min. In addition, a dip coating method in which an object to be coated is dipped in a coating solution and then dried can also be used. Preferably, the water content in the coating preparation is dried to 0.1 to 20% by mass.

Example

Hereinafter, the present invention will be specifically described by giving Examples and Comparative Examples, but the present invention is not limited to the following Examples. In addition, in the following examples, unless otherwise specified, "%" of the composition represents mass %, and ratio represents mass ratio.

Examples 1-78, Comparative Examples 1-4

Prepare the following plain tablets, prepare the coating solutions with the compositions shown in the following Tables 1-22, and coat the plain tablets according to the following method to prepare coated tablets.

[Tablets]

Mix the following raw materials, and use a tablet machine to compress into tablets (300mg, Thickness 5mm).

<Plain composition>

Lactoferrin: 1,156g

Piper extract powder: 500g

Lactose: 492.5g

Microcrystalline cellulose: 731.5g

Sodium carboxymethylcellulose: 60g

Sucrose fatty acid ester: 30g

Silica particles: 30g

[Preparation of coating solution]

Components (A) and (C) in the coating solution compositions described in Tables 1 to 22 were uniformly dissolved in hot water, respectively, and the dissolved liquid was mixed, and other components were added, and further mixed and stirred. In addition, the right column in a table shows solid content (%).

[coating]

Using a coating machine (manufactured by POWREX (パウレック), POWREX COATER-PRC-05), spray 200 g of plain tablets with 100 g of coating solution (60°C) at an average rate of 2 g/min, and coat at a product temperature of about 50°C . After spraying, it was dried at about 45° C. for 2 minutes to obtain a coated agent (tablet). The thickness of the coating film is in the range of 10 to 200 μm.

[Acidic pH Insolubility Test]

Using the Japanese Pharmacopoeia 1 solution (pH 1.2), the dissolution test was carried out according to the Japanese Pharmacopoeia general test method (paddle method).

◎: Dissolution within 2 hours is 10% or less

○: Dissolution in 2 hours exceeds 10% and is 30% or less

△: Dissolution in 2 hours exceeds 30% and is less than 50%

×: Dissolution in 2 hours is 50% or less

[Neutral to Alkaline pH Dissolution Test]

Using the Japanese Pharmacopoeia 2 solution (pH 6.8), the dissolution test was carried out according to the Japanese Pharmacopoeia general test method (paddle method).

○: Dissolution in 2 hours is 70% or more

△: Dissolution in 2 hours is 30% or more and less than 70%

×: Dissolution in 2 hours is less than 30%

In addition, when it is "△", "○" or "◎" in the above-mentioned [Acidic pH Dissolution Test] and "○" in the above-mentioned [Neutral-Alkaline pH Dissolution Test], it is defined as "enteric-soluble". ".

[Coating properties]

Coatability was evaluated based on the following evaluation criteria.

◎: Uniform coating, no defect or peeling, and the coating surface is glossy.

○: Uniform coating, almost no defect or peeling, but the coating surface is slightly chapped.

Δ: Coating defects were observed on some tablets.

X: Chipping or peeling of the coating was observed on almost all tablets.

【Table 1】

【Table 2】

【table 3】

【Table 4】

【table 5】

【Table 6】

【Table 7】

【Table 8】

【Table 9】

【Table 10】

【Table 11】

【Table 12】

【Table 13】

【Table 14】

【Table 15】

【Table 16】

【Table 17】

【Table 18】

【Table 19】

【Table 20】

【Table 21】

【Table 22】

The number of moles of calcium ions relative to 1 mole of the alginate monomer of Examples 75 to 78 is as follows.

Example 75: 0.014mol

Example 76: 0.027mol

Example 77: 0.041mol

Example 78: 0.054mol

<Test Example 1>

Put 6 coated tablets prepared in Example 38, Example 53, and Comparative Examples 1 and 2 into 100 mL of pH 1.2 (Japanese Pharmacopoeia 1 liquid + pepsin dissolution test liquid) at 37°C, and shake Machine stirring for 2 hours. Then, it was treated at 100° C. for 20 minutes to inactivate pepsin. After cooling to 37° C., 110 mL of a 37° C. pH 8.5 sodium bicarbonate aqueous solution was added to adjust the pH to about 6.0, followed by further shaking and stirring for 2 hours. This liquid was filtered through a 0.45 μm filter and used as an evaluation sample.

Human preadipocytes diluted with visceral adipocyte differentiation medium (Primary Cell Co., Ltd., Tokyo, Japan) to a concentration of 3.0× ¹⁰⁵ cells/ ^cm2 were seeded in 24-well plates, and placed in a 5% concentration _CO2 environment cultured at 37°C for 6 days. Then, 1 mL of a liquid obtained by diluting the evaluation sample 10 times with a culture medium was added, and cultured for 24 hours. The glycerol concentration in the culture supernatant was then measured. Compared with the control group and Comparative Example 1, it was confirmed that the concentration of glycerin in Examples increased by promoting lipolysis by lactoferrin, and that the coated tablets of Examples were enteric-coated. The result is shown in Figure 1.

Raw materials used in the preparation of Examples and Comparative Examples are as follows. In addition, the amount of each component is shown in a table|surface.

【Table 23】

【Table 24】

Claims (9)

1. A coating composition comprising (A) alginate and (B) a plasticizer, as the component (A), seaweed having a viscosity of 1% by mass aqueous solution at 20° C. exceeding 50 mPa·s Alginate (A-1) and an alginate (A-2) whose viscosity at 20°C is 50 mPa·s or less in a 1% by mass aqueous solution. 2. The coating composition according to claim 1, wherein the component (A) is an alginate selected from the group consisting of sodium alginate, potassium alginate, and ammonium alginate. 3. The coating composition according to claim 1 or 2, wherein the component (B) is glycerin and/or sucrose fatty acid ester. 4. The coating composition as claimed in claim 1 or 2, which further contains (C) selected from gelatin, pectin, curdlan, pullulan, gum arabic, xanthan gum, gellan gum, Ingredients of hydroxypropyl methylcellulose, sodium carboxymethylcellulose and hydroxypropyl cellulose. The coating composition according to claim 4, wherein the content mass ratio represented by (A):(C) is 1:10 to 20:1. 6. The coating composition according to claim 1 or 2, further comprising (D) fine particles. The coating preparation which has the coating film formed from the coating composition in any one of Claims 1-6. 8. The coating preparation according to claim 7, which is an enteric coating preparation in which the coating film is enteric. 9. A method for producing a coating preparation, comprising the steps of: spraying a coating solution containing the coating composition according to any one of claims 1 to 6 and water to an object to be coated and drying it, thereby A coating film is formed on the surface of the coating.