TWI587880B - Can be made into the composition of enteric capsule shell, enteric capsule shell and its process - Google Patents

Description

It can be made into the composition of enteric capsule shell, enteric capsule shell and its preparation process

The present invention relates to a composition which can be made into an enteric capsule shell; the present invention relates to an enteric capsule shell and a process thereof.

In the field of oral medicine, capsules are a widely used pharmaceutical form. The drug is loaded into the capsule to avoid direct contact between the drug and the taste organ, causing nausea or decomposition by saliva, and allowing the drug to react with the outside world. Air, light and other factors that may cause the deterioration of the drug are isolated, and also have the function of delaying the release of the drug.

The main component of the capsule is gelatin, which dissolves in gastric acid and releases the drug loaded in it. Or, some drugs may cause serious side effects if released in the stomach, such as non-steroidal anti-inflammatory. Nonsteroidal anti-inflammatory drugs (NSAIDs) can cause damage to the gastric mucosa, stomach bleeding or perforation.

In order to overcome the above problems, an enteric capsule shell is developed on the market which can prevent the drug component contained in the enteric capsule shell from being released in the strong acid environment of the stomach, while the enteric capsule shell moves to the intestinal tract to be relatively alkaline. In the environment, the pharmaceutical ingredients contained in the enteric capsule shell are released and absorbed by the intestines, thereby reducing the side effects of the pharmaceutical ingredients on the stomach.

The preparation method of the enteric capsule shell on the market is divided into two types, one of which is after the preparation of the general capsule without the acid-proof property, and then the outer capsule is wrapped with an enteric film to form an enteric capsule shell. The enteric film coat has an acid-resistant property by the enteric film coat, and the enteric film coat has a solubility varying with a pH value. Generally, the enteric film coat is made of cellulose acetate glutamate ( Cellulose acetate phthalate, CAP), hydroxypropyl methylcellulose phthalate (HPMCP), cellulose acetate hydroxypropylated succinate Hydroxypropyl methylcellulose acetate succinate, HPMP-AS), acrylic copolymers or shellac. However, the preparation process of the enteric capsule shell by the method is complicated, and the components of the enteric film coat are required to be dissolved in the organic solvent. Therefore, the capsule which has been loaded with the pharmaceutical ingredient is usually wrapped in the enteric film coat. The residual organic solvent occurs.

Another method for preparing an enteric capsule shell is a double dipping method which is modified from a dip molding process used in a general capsule process in which a soaking needle is sequentially immersed in a The gelatin solution and an enteric film coating solution are dried to form an enteric capsule shell, but since the composition of the enteric film coating solution is the same as that of the above-mentioned enteric film coating, it must be dissolved in the organic solvent, so the second soaking The method still has the problem of residual organic solvent, and the equipment used in the secondary immersion method is more expensive than the general immersion forming method, and the production cost is also increased. Therefore, the enteric capsule shells currently on the market still have problems such as complicated process steps, expensive preparation, and residual organic solvents.

The purpose of this creation is to produce an enteric capsule shell which has excellent acid resistance characteristics and no problem of residual organic solvents in the conventional apparatus and process for producing capsules.

The present invention provides a composition capable of being made into an enteric capsule shell comprising: a water-soluble enteric polymer having a molecular weight of 20 kDa to 1000 kDa, the water-soluble enteric polymer Soluble in water and comprising at least one hydrophobic functional group and at least one hydrophilic functional group; a water-soluble film-forming polymer, which is gelatin, pullulan, polyvinyl alcohol, Modified starch, cellulose ester, or a combination thereof, and having a molecular weight of 50 kDa to 815 kDa; a coagulant, which is gellan gum or carrageen, and The molecular weight is from 450 kDa to 550 kDa; and a gelling aid; the water-soluble enteric polymer, the water-soluble film-forming polymer, the total weight of the aggregating agent and the coagulant is 100 wt %, the water-soluble enteric polymer has a weight percentage (wt%) of 5 wt% to 25 wt%, and the water-soluble film-forming polymer has a weight percentage of 71 wt% to 94.45 wt%. The weight percentage of the aggregating agent is from 0.5 wt% to 3 wt%, Weight percent based coagulant is 0.005 wt% to 1 wt%.

The water-soluble enteric polymer has acid-resistance property, and the acid-resistant property means that the water-soluble enteric polymer is water-insoluble in a gastric acid environment, and is water-soluble in an intestinal environment, and requires special explanation. Yes, the water-soluble enteric polymer does not contain gelatin, polytriglucose, polyvinyl alcohol, modified starch or cellulose ester.

The composition which can be made into an enteric capsule shell is used as a starting material for the subsequent preparation of the enteric capsule shell, and the component which can be made into the composition of the enteric capsule shell is soluble in water, and thus is used for preparing the intestine. The organic solvent is not required for the soluble capsule shell, so the problem of residual organic solvent can be avoided.

Preferably, the water-soluble enteric polymer is pectin, propylene glycol alginate (PGA) or xanthan gum; more preferably, the water-soluble one The enteric polymer is pectin or propylene glycol alginate; more preferably, the water-soluble enteric polymer is pectin.

Preferably, the water-soluble enteric polymer has a molecular weight of from 40 kDa to 400 kDa; more preferably, the water-soluble enteric polymer has a molecular weight of from 50 kDa to 200 kDa.

Preferably, the ratio of the hydrophobic functional group to the hydrophilic functional group of the water-soluble enteric polymer is from 30:70 to 70:30; more preferably, the water-soluble enteric polymer is hydrophobic The ratio of the functional functional group to the hydrophilic functional group is from 40:60 to 60:40; even more preferably, the ratio of the hydrophobic functional group to the hydrophilic functional group of the water-soluble enteric polymer is from 45:55 to 55:45. When the ratio of the hydrophobic functional group is less than 30%, the enteric capsule shell prepared from the composition capable of being made into the enteric capsule shell will excessively absorb water in the aqueous solution to cause appearance deformation, which may result in enteric capsules. The drug component loaded in the shell is released at an unintended position due to deformation.

Preferably, the hydrophobic functional group of the water-soluble enteric polymer comprises a methoxy group or a propylene glycol or a combination thereof; the hydrophilic function of the water-soluble enteric polymer The group includes a carboxyl group or an amino group or a combination thereof.

More preferably, the hydrophobic functional group of the water-soluble enteric polymer comprises a methoxy group; and the hydrophilic functional group of the water-soluble enteric polymer comprises a carboxylic acid group.

Preferably, the modified starch comprises hydroxypropylated starch or hydroxyethylated starch.

Preferably, the cellulose ester comprises hydroxypropyl methylcellulose (HPMC), hydroxypropyl cellulose, methylcellulose, hydroxyethyl cellulose. Or hydroxyethyl methylcellulose.

Preferably, the water-soluble film-forming polymer has a molecular weight of from 50 kDa to 400 kDa.

Preferably, the coagulant is a monovalent cation salt, a divalent cation salt or a trivalent cation salt; more preferably, the coagulant is a monovalent cation salt, so that the enteric capsule shell can be made into an enteric capsule. The composition is dried at a high temperature (e.g., 70 ° C to 90 ° C) during the preparation of the enteric capsule shell to accelerate the speed of the process without causing brittle fracture of the enteric capsule shell.

More preferably, the monovalent cation salt is potassium chloride (KCl) or sodium chloride (NaCl); the divalent cation salt is calcium chloride (CaCl ₂ ) or magnesium chloride (magnesium chloride) , MgCl ₂ ).

The present invention further provides a method for preparing an enteric capsule shell, comprising: mixing a composition of an enteric capsule shell and water as described above to obtain a capsule shell mixture; heating and then cooling the capsule shell mixture, Obtaining a capsule shell preparation liquid; soaking a soaking needle into the capsule shell preparation liquid, and removing the soaking needle from the capsule shell preparation liquid to obtain a soaking needle with a glue solution; and drying the glued glue The liquid is soaked in the needle to obtain the enteric capsule shell from the soaking needle.

Preferably, the step of heating and then cooling the capsule shell mixture to obtain the capsule shell preparation liquid comprises: heating the capsule shell mixture at a temperature of 65 ° C to 90 ° C; cooling the capsule shell mixture Liquid to obtain the capsule shell preparation liquid.

More preferably, the temperature at which the capsule shell mixture is heated is between 75 ° C and 85 ° C.

Preferably, the step of drying the glue-impregnated soaking needle to obtain the enteric capsule shell from the soaking needle comprises: drying the temperature of the soaking needle with the glue solution at 20 ° C to The enteric capsule shell was obtained from the soaking needle at 90 °C.

More preferably, the temperature of the soaking needle with the glue is between 20 ° C and 80 ° C; more preferably, the temperature of the dipping needle with the glue is between 20 ° C. Up to 70 ° C.

Alternatively, the temperature of the dipping needle with the glue is between 70 ° C and 80 ° C.

Preferably, the step of heating and then cooling the capsule shell mixture to obtain the capsule shell preparation liquid comprises: heating the capsule shell mixture; cooling the capsule shell mixture at a temperature of 50 ° C to 60 ° C, to obtain the capsule shell preparation liquid.

Preferably, the temperature of the capsule shell preparation liquid is maintained between 50 ° C and 60 ° C.

Preferably, the capsule shell preparation has a pH of from pH 4 to pH 6.

The present invention further provides an enteric capsule shell comprising: a water-soluble enteric polymer having a molecular weight of 20 kDa to 1000 kDa, the water-soluble enteric polymer soluble in water and comprising at least one hydrophobic function And a water-soluble film-forming polymer, which is gelatin, polytriglucose, polyvinyl alcohol, modified starch, cellulose ester or a combination thereof, and has a molecular weight of 50 kDa to 815 kDa; An agglutinating agent, which is a gellan gum or carrageenan, and has a molecular weight of 450 kDa to 550 kDa; and a moisture; the water-soluble enteric property is 100% of the total weight of the enteric capsule shell The weight percentage of the molecule is 5 wt% to 25 wt%, the weight percentage of the water-soluble film-forming polymer is 65 wt% to 90.5 wt%, and the weight percentage of the aggregating agent is 0.5 wt% to 3 wt%. The weight percentage of water is from 4 wt% to 7 wt%.

Preferably, the water-soluble enteric polymer is pectin, propylene glycol alginate or trisanthine; more preferably, the water-soluble enteric polymer is pectin or propylene glycol alginate; More preferably, the water-soluble enteric polymer is pectin.

Preferably, the water-soluble enteric polymer has a molecular weight of from 40 kDa to 400 kDa; more preferably, the water-soluble enteric polymer has a molecular weight of from 50 kDa to 200 kDa.

Preferably, the ratio of the hydrophobic functional group to the hydrophilic functional group of the water-soluble enteric polymer is from 30:70 to 70:30; more preferably, the water-soluble enteric polymer is hydrophobic The ratio of the functional functional group to the hydrophilic functional group is from 40:60 to 60:40; even more preferably, the ratio of the hydrophobic functional group to the hydrophilic functional group of the water-soluble enteric polymer is from 45:55 to 55:45.

Preferably, the hydrophobic functional group of the water-soluble enteric polymer comprises a methoxy or propylene glycol group or a combination thereof; the hydrophilic functional group of the water-soluble enteric polymer comprises a carboxylic acid group or an amino group or Its combination.

More preferably, the hydrophobic functional group of the water-soluble enteric polymer comprises a methoxy group; and the hydrophilic functional group of the water-soluble enteric polymer comprises a carboxylic acid group.

Preferably, the modified starch comprises hydroxypropylated starch or hydroxyethylated starch.

Preferably, the cellulose ester comprises hydroxypropylmethylcellulose, hydroxypropylcellulose, methylcellulose, hydroxyethylcellulose or hydroxyethylmethylcellulose.

Preferably, the water-soluble film-forming polymer has a molecular weight of from 50 kDa to 400 kDa.

The composition of the enteric capsule shell can be prepared according to the preparation method of the enteric capsule shell, and the enteric capsule shell can be prepared with excellent acid resistance and acid resistance. The enteric polymer is water-insoluble in a gastric acid environment (about pH 1.2), and water-soluble in the intestinal environment (about pH 6.8), and is completely free of organic solvents during the process, so it can be avoided. The problem of residual organic solvents.

Example 1

The present embodiment provides a method for preparing an enteric capsule shell, which is prepared by mixing a composition which can be made into an enteric capsule shell and dissolving in 6.1 kg of deionized water to obtain deionized water. a capsule shell mixture, the capsule shell mixture is heated and stirred at 80 ° C until completely dissolved, and cooled to 55 ° C to obtain a capsule shell preparation liquid, wherein the capsule shell preparation liquid has a pH value of pH 4.5.

The composition capable of being made into an enteric capsule comprises a water-soluble enteric polymer, a water-soluble film-forming polymer, a coagulating agent and a coagulant, and the water-soluble enteric polymer has acid resistance. The acid-resistant property means that the water-soluble enteric polymer is water-insoluble in a gastric acid environment (about pH 1.2), and water-soluble in an intestinal environment (about pH 6.8), and the water-soluble enteric property is high. The molecule is pectin (molecular weight 40kDa to 400 kDa), pectin contains hydrophobic functional group (methoxy group) and hydrophilic functional group (carboxylic acid group), and the hydrophobic functional group of pectin and hydrophilic functional group The ratio is 30:70, and the ratio of the functional groups of the pectin is determined according to the United States Pharmacopeial Convention (USP<33>); the water-soluble film-forming polymer is hydroxypropylmethylcellulose. The molecular weight is about 80 kDa; the agglutinating agent is aramid, and its molecular weight is about 500 kDa; the coagulant is potassium chloride, which can be made into a composition of an enteric capsule shell (referred to as "composition" in Table 1 The amount of each component used in the ")" is shown in Table 1.

Pour the capsule shell preparation liquid into the glue tank, and maintain the temperature of the capsule shell preparation liquid at 50 ° C to 55 ° C, soak a soaking needle in the capsule shell preparation liquid, and soak the needle from the capsule shell The preparation liquid is removed to obtain a soaking needle with a glue solution, and the soaking needle with the glue liquid is dried at 80 ° C to obtain a transparent enteric capsule shell, and the components of the enteric capsule shell are The weight percentage series is shown in Table 1. Table 1: The amount of each component in the composition of the enteric capsule shells of Examples 1 to 4 and Comparative Examples 1 to 3 and the weight percentage of each component in the enteric capsule shell Example 2

The present embodiment provides a preparation method of an enteric capsule shell, which is substantially the same as the preparation method of the enteric capsule shell of Example 1, except that the water-soluble film-forming polymer is polytriglucose (pullulan). Its molecular weight is about 805 kDa. The amounts of the ingredients used in the composition of the enteric capsule shell are shown in Table 1, and the weight percentages of the ingredients in the enteric capsule shell are shown in Table 1. Example 3

The present embodiment provides a preparation method of an enteric capsule shell, which is substantially the same as the preparation method of the enteric capsule shell of Example 1, except that the water-soluble enteric polymer is propylene glycol alginate (propylene). Glycol alginate) having a molecular weight of about 240 kDa, alginate propylene glycol having a hydrophobic functional group (propylene glycol group) and a hydrophilic functional group (carboxylic acid group), and the ratio of hydrophobic functional groups to hydrophilic functional groups of alginate propylene glycol It is 35:65; the water-soluble film-forming polymer is hydroxypropylmethylcellulose, and its molecular weight is about 130 kDa. The amounts of the ingredients used in the composition of the enteric capsule shell are shown in Table 1, and the weight percentages of the ingredients in the enteric capsule shell are shown in Table 1. Example 4

The present embodiment provides a preparation method of an enteric capsule shell, which is substantially the same as the preparation method of the enteric capsule shell of Example 1, except that the water-soluble enteric polymer is pectin and pectin. The ratio of the hydrophobic functional group to the hydrophilic functional group is 40:60; and the insoluble capsule having the glue solution is dried at 30 ° C to obtain the enteric capsule shell which is transparent. The amounts of the ingredients used in the composition of the enteric capsule shell are shown in Table 1, and the weight percentages of the ingredients in the enteric capsule shell are shown in Table 1. Comparative Example 1

The present invention provides a preparation method of an enteric capsule shell, which is substantially the same as the preparation method of the enteric capsule shell of Example 1, except that the water-soluble enteric polymer is pectin and pectin. The ratio of hydrophobic functional groups to hydrophilic functional groups is 28:72. The amounts of the ingredients used in the composition of the enteric capsule shell are shown in Table 1, and the weight percentages of the ingredients in the enteric capsule shell are shown in Table 1. Comparative Example 2

This comparative example provides a preparation method of an enteric capsule shell, which is substantially the same as the preparation method of the enteric capsule shell of Example 1, except that the coagulant is calcium chloride, and the capsule shell mixture The system is heated and stirred at 90 ° C, and the soaked needle with the glue solution is dried at 70 ° C to obtain an enteric capsule shell, but the surface of the enteric capsule shell is cracked. The amounts of the ingredients used in the composition of the enteric capsule shell are shown in Table 1, and the weight percentages of the ingredients in the enteric capsule shell are shown in Table 1. Comparative Example 3

The present invention provides a preparation method of an enteric capsule shell, which is substantially the same as the preparation method of the enteric capsule shell of Example 1, except that the water-soluble enteric polymer is pectin and pectin. The ratio of hydrophobic functional groups to hydrophilic functional groups is 72:28. The amounts of the ingredients used in the composition of the enteric capsule shell are shown in Table 1, and the weight percentages of the ingredients in the enteric capsule shell are shown in Table 1. Test case

The enteric capsule shells prepared in the above Examples 1 to 4 and Comparative Examples 1 to 3 were individually filled with acetaminophen (solid powder) according to the United States Pharmacopeial Convention (USP). <711>) An in-vitro dissolution test was performed.

In the first stage of the in vitro dissolution test, the enteric capsule shell was placed in a simulated gastric acid solution. The pH value of the simulated gastric acid solution was pH 1.2 and the temperature was 37 ° C. The enteric capsule was placed in the simulation. After 2 hours in the gastric acid solution, the concentration of the filler (ie, acetaminophen) in the simulated gastric acid solution was measured, and the concentration measured at this time was the first-stage dissolution test concentration, and the concentration was measured by the first-stage dissolution test and The elution rate of the acetaminophen in the first stage of the in vitro dissolution test can be determined by the weight of the filler. For the detailed calculation method, please refer to USP<711>.

The second stage of the in vitro dissolution test is carried out after the first stage of the in vitro dissolution test, which adjusts the pH value of the simulated gastric acid solution to pH 6.8 within five minutes to obtain a simulated intestinal solution, which simulates the intestine The channel solution simulates the intestinal environment. After the enteric capsule is placed in the simulated intestinal solution for 45 minutes, the concentration of the filler in the simulated intestinal solution is measured, and the concentration measured at this time is the second stage dissolution. The concentration of the test can be determined by the second stage dissolution test concentration and the weight of the filler. The dissolution rate of the second stage of the in vitro dissolution test can be determined. For the detailed calculation method, please refer to USP<711>.

The dissolution rates of the first stage and the second stage of the insoluble dissolution test of the enteric capsule shells prepared in Examples 1 to 4 and Comparative Examples 1 and 3 are shown in Table 2. Table 2: The dissolution rate of the first stage and the second stage of the insoluble dissolution test of the enteric capsule shells prepared in Examples 1 to 4 and Comparative Examples 1 and 3

The dissolution rate of the enteric capsule shell prepared in Comparative Example 1 in the first stage of the in vitro dissolution test was as high as 35%, and the enteric capsule shell prepared in Comparative Example 1 was severely in the appearance of the enteric capsule shell in the in vitro dissolution test. The deformation is that the ratio of the hydrophobic functional group to the hydrophilic functional group of the pectin used in Comparative Example 1 is 28:72, and when the ratio of the hydrophilic functional group is too high, the enteric capsule shell is easily prepared. Excessive water absorption causes deformation, so that the filled contents of the prepared enteric capsule shell are released under unintended conditions; in contrast, the enteric capsule shells prepared in Examples 1 to 4 are in the first stage of the in vitro dissolution test. The dissolution rate is less than 16%, and the appearance of the enteric capsule shell prepared is complete, and the dissolution rate of the enteric capsule shell prepared in Examples 1 to 4 is greater than 60% in the in vitro dissolution test. The prepared enteric capsule shell has excellent acid resistance.

The insoluble capsule shell prepared in Comparative Example 2 has no correlation data on the dissolution rate of the first stage and the second stage of the in vitro dissolution test because the coagulant is dried at 70 ° C when it is calcium chloride. When the soaking needle with the glue is applied, the formed enteric capsule shell will be brittle and cannot be used. Therefore, when calcium chloride or other divalent cation salt is used as a coagulant, the drying temperature should be set at least low. At 60 ° C, this will increase the time required for drying, which will be detrimental to the rapid production of the enteric capsule shell; the dissolution rate of the first stage of the in vitro dissolution test prepared by the enteric capsule shell prepared in Example 1 It is less than 10%, and the appearance of the enteric capsule shell is complete. This shows that the creation of the present invention can be dried at a high temperature, which is advantageous for the rapid production of the enteric capsule shell.

The dissolution rate of the enteric capsule shell prepared in Comparative Example 3 in the first stage of the in vitro dissolution test was as high as 38%, which was because the ratio of the hydrophobic functional group to the hydrophilic functional group of the pectin used in Comparative Example 3 was At 72:28, when the ratio of the hydrophobic functional group is too high, the prepared enteric capsule shell dissolves in the in vitro dissolution test, so that the filled shell of the enteric capsule shell is unintended. Release in case.

The above description is only illustrative of the present invention, and is not intended to limit the scope of the present invention. The scope of the present invention is defined by the scope of the patent application, and is not limited to the above embodiments. Any equivalents of the above-disclosed technical contents may be modified or modified to equivalent variations, without departing from the scope of the present invention. The content of the technical solution, any simple modification, equivalent change and modification of the above embodiment according to the technical essence of the present invention are still within the scope of the technical solution of the present invention.

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Claims (18)

A composition capable of being made into an enteric capsule shell, comprising: a water-soluble enteric polymer having a molecular weight of 20 kDa to 1000 kDa, the water-soluble enteric polymer comprising at least one hydrophobic a functional group and at least one hydrophilic functional group, the ratio of the at least one hydrophobic functional group to the at least one hydrophilic functional group is from 30:70 to 70:30; a water-soluble film-forming polymer which is gelatin or poly Triglucose, polyvinyl alcohol, modified starch, cellulose ester or a combination thereof, and having a molecular weight of 50 kDa to 815 kDa; an agglutinating agent which is a gellan gum or carrageenan, and has a molecular weight of 450 kDa to 550 kDa; a coagulant; the water-soluble enteric polymer, the water-soluble film-forming polymer, the total weight of the coagulant and the coagulant is 100% by weight, and the weight percentage of the water-soluble enteric polymer is 5wt % to 25% by weight, the water-soluble film-forming polymer is 71% by weight to 94.45% by weight, the aggregating agent is 0.5% by weight to 3% by weight, and the coagulant is 0.005wt by weight. % to 1wt%. The composition of the enteric capsule shell according to claim 1, wherein the ratio of the hydrophobic functional group to the hydrophilic functional group of the water-soluble enteric polymer is from 40:60 to 60:40. The composition of the enteric capsule shell according to claim 2, wherein the ratio of the hydrophobic functional group to the hydrophilic functional group of the water-soluble enteric polymer is from 45:55 to 55:45. The composition of the enteric capsule shell according to any one of claims 1 to 3, wherein the hydrophobic functional group of the water-soluble enteric polymer comprises a methoxy group or a propylene glycol group or a combination thereof; The hydrophilic functional group of the water-soluble enteric polymer comprises a carboxylic acid group or an amino group or a combination thereof. The composition of the enteric capsule shell according to any one of claims 1 to 3, wherein the hydrophobic functional group of the water-soluble enteric polymer comprises a methoxy group; the water-soluble enteric property is high The hydrophilic functional group of the molecule comprises a carboxylic acid group. The composition of the enteric capsule shell according to any one of claims 1 to 3, wherein the water-soluble enteric polymer is pectin, propylene glycol alginate or trisanthine. According to the invention of claim 6, the composition of the enteric capsule shell can be prepared, wherein the water-soluble enteric polymer is pectin or propylene glycol alginate. According to claim 7, the composition of the enteric capsule shell can be prepared, wherein the water-soluble enteric polymer is pectin. The composition of the enteric capsule shell according to any one of claims 1 to 3, wherein the coagulant is a monovalent cation salt or a divalent cation salt. The composition of the enteric capsule shell according to claim 9 wherein the coagulant is a monovalent cation salt. The composition of the enteric capsule shell according to any one of claims 1 to 3, wherein the water-soluble enteric polymer has a molecular weight of from 40 kDa to 400 kDa. The composition of the enteric capsule shell according to claim 9, wherein the water-soluble enteric polymer has a molecular weight of from 50 kDa to 200 kDa. A method for preparing an enteric capsule shell, comprising: mixing the composition of the enteric capsule shell and water according to any one of the preceding claims 1 to 12 to obtain a capsule shell mixture; heating Cooling the capsule shell mixture to obtain a capsule shell preparation liquid; soaking a soaking needle into the capsule shell preparation liquid, and removing the soaking needle from the capsule shell preparation liquid to obtain a soaking needle with a glue solution And drying the soaking needle with the glue to obtain the enteric capsule shell from the soaking needle. The method for preparing an enteric capsule shell according to claim 13, wherein the step of heating and then cooling the capsule shell mixture to obtain a capsule shell preparation liquid comprises: heating the capsule shell mixture at a temperature of 65 ° C to 90 ° C; the capsule shell mixture was cooled to obtain the capsule shell preparation liquid. The method for preparing an enteric capsule shell according to claim 13, wherein the step of drying the soaking needle with the glue to obtain the enteric capsule shell from the soaking needle comprises: drying the soaked with the glue solution The temperature of the needle is between 20 ° C and 90 ° C to obtain the enteric capsule shell from the soaking needle. An enteric capsule shell comprising: a water-soluble enteric polymer having a molecular weight of from 20 kDa to 1000 kDa, the water-soluble enteric polymer soluble in water and comprising at least one hydrophobic functional group and at least one hydrophilicity a functional group, the ratio of the at least one hydrophobic functional group to the at least one hydrophilic functional group is from 30:70 to 70:30; a water-soluble film-forming polymer which is gelatin, polytriglucose, polyvinyl alcohol, Modified starch, cellulose ester or a combination thereof, and having a molecular weight of 50 kDa to 815 kDa; an agglutinating agent which is a gellan gum or carrageenan, and has a molecular weight of 450 kDa to 550 kDa; and water; and the enteric capsule shell The total weight is 100%, the weight percentage of the water-soluble enteric polymer is 5 wt% to 25 wt%, and the weight percentage of the water-soluble film-forming polymer is 65 wt% to 90.5 wt%, and the weight percentage of the aggregating agent It is from 0.5% by weight to 3% by weight, and the weight percentage of water is from 4% by weight to 7% by weight. The enteric capsule shell according to claim 16, wherein the water-soluble enteric polymer is pectin, propylene glycol alginate or trisanthine. The enteric capsule shell according to claim 16, wherein the hydrophobic functional group of the water-soluble enteric polymer comprises a methoxy group or a propylene glycol group or a combination thereof; and a hydrophilic functional group of the water-soluble enteric polymer; A carboxylic acid group or an amino group or a combination thereof is included.