Uncoated enteric soft capsule composition

Abstract

The invention provides an uncoated enteric-coated soft capsule composition, and relates to the technical field of health-care product preparations. The enteric soft capsule composition is composed of an enteric sol skin layer and functional contents wrapped in the enteric sol skin layer. The enteric sol skin layer can be prepared from gelatin, glycerol, purified water, pectin, locust bean gum, agar and the like; the soft capsule can also be prepared from gelatin, glycerin, purified water, gellan gum, carrageenan, xanthan gum and the like. The enteric soft capsule is composed of the enteric sol skin layer and the functional content, the enteric sol skin layer prepared from specific components and proportions can protect the capsule from being disintegrated in gastric juice, and the enteric effect is achieved; a traditional coating layer is replaced by the soft rubber layer, so that additional negative effects caused by a traditional enteric capsule coating can be avoided.

Description

Technical Field

[0001] The present application relates to the technical field of health care product preparations, and in particular to an uncoated enteric soft capsule composition. Background Art

[0002] Enteric-coated capsules refer to hard capsules made by filling granules or pellets coated with enteric materials into capsules, or hard capsules or soft capsules made of suitable enteric materials. Enteric-coated preparations refer to preparations that do not release or almost do not release drugs in the stomach within a specified time, but can release most or all of the drugs in a certain part of the intestine after entering the intestine. Enteric-coated capsules are a type of enteric-coated preparations.

[0003] Compared with other capsules, enteric-coated capsules have the following advantages: 1. Protect gastric mucosa from irritation: Some drugs may cause irritation and damage to the gastric mucosa, and enteric-coated capsules can prevent such irritation in the gastric acid environment. 2. Prolong the duration of drug action: Enteric-coated capsules can prolong the residence time of drugs in the small intestine, increase the contact area between the drug and the intestinal wall, and thus increase the amount of drug absorbed by the intestine; 3. Reduce drug dosage: Because enteric-coated capsules have a protective effect, they can reduce the dosage of drugs and reduce the burden of drugs on other organs of the human body. 4. Improve the utilization rate of capsules: Enteric-coated capsules mainly deliver drugs absorbed by the small intestine to this part at the highest possible concentration, thereby improving bioavailability.

[0004] However, traditional enteric capsules achieve the enteric effect through coating (enteric material wrapped outside) and enteric hard capsule shells, but ordinary coating has the following problems: 1. Adhesion: During the coating process, if the droplets collide with other particles without being completely dried, the particles may stick together. This will cause the coating film to tear from the tablet core, forming an uncoated area or a local over-thickness phenomenon, affecting the uniformity and integrity of the coating; 2. Affecting the mechanical properties of the tablet core: The hardness and brittleness of the tablet core have a decisive influence on the quality of the film coating. If the mechanical properties of the tablet core are not good, it is difficult to ensure the quality of the film even if the film coating is barely carried out; 3. Increased production costs: Although coating can improve the stability of the drug and the patient's medication experience, the coating process may increase production costs, including material costs, equipment costs, and production time costs; 4. May affect the dissolution and absorption of the drug: If the quality of the coating layer is poor, such as uneven or too thick, it may affect the dissolution rate and absorption of the drug, thereby affecting the efficacy. Summary of the invention

[0005] The purpose of the present application is to provide an uncoated enteric soft capsule composition, which has the effect of maintaining excellent enteric disintegration performance without the need for coating.

[0006] In order to solve the above technical problems, the technical solution adopted in this application is:

[0007] The present application provides an uncoated enteric soft capsule composition, which consists of an enteric gum layer and functional contents wrapped in the gum layer.

[0008] The composition of the enteric gel cortex can be composed of gelatin, glycerin, purified water, pectin, locust bean gum and agar; it can also be composed of gelatin, glycerin, purified water, gellan gum, carrageenan and xanthan gum.

[0009] Compared with the prior art, the embodiments of the present application have at least the following advantages or beneficial effects:

[0010] The enteric soft capsule of the present application is composed of an enteric gel layer and functional contents, wherein the enteric gel layer prepared with specific components and proportions can protect the capsule from being disintegrated in gastric juice and achieve an enteric effect; the soft gel layer replaces the traditional coating layer, thereby avoiding the negative effects caused by the additional coating of the traditional enteric capsule, and simplifies the preparation process of the enteric soft capsule after omitting the coating, thereby achieving an enteric effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings required for use in the embodiments will be briefly introduced below. It should be understood that the following drawings only show certain embodiments of the present application and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other related drawings can be obtained based on these drawings without paying creative work.

[0012] Figure 1 The glue-making equipment used in Example 1 of the present application;

[0013] Figure 2 The pellet pressing device used in Example 1 of the present application;

[0014] Figure 3 This is the enteric-coated soft capsule product prepared in Example 1 of the present application. DETAILED DESCRIPTION

[0015] In order to make the purpose, technical scheme and advantages of the embodiments of the present application clearer, the technical scheme in the embodiments of the present application will be described clearly and completely below. If the specific conditions are not specified in the embodiments, they are carried out according to the conventional conditions or the conditions recommended by the manufacturer. If the manufacturer is not specified for the reagents or instruments used, they are all conventional products that can be purchased commercially.

[0016] It should be noted that, in the absence of conflict, the embodiments and features in the embodiments of the present application can be combined with each other. The present application will be described in detail below with reference to specific embodiments.

[0017] The invention discloses an uncoated enteric soft capsule composition, which consists of an enteric gelatin layer and functional contents wrapped in the gelatin layer.

[0018] In some embodiments of the present application, the functional contents include one or more of fish oil, krill oil, garlic oil, probiotic composition, and Chinese medicine extract.

[0019] In some embodiments of the present application, the components of the enteric gum layer include gelatin, glycerin, purified water, pectin, locust bean gum and agar.

[0020] In some embodiments of the present application, the components of the enteric gum layer are, by mass percentage, 37-42% gelatin, 17-18% glycerol, 35-40% purified water, 0.5-8% pectin, 0.1-2.0% locust bean gum and 0.1-2.0% agar.

[0021] Gelatin is a mixture of polypeptide molecules with a wide molecular weight distribution. It is a hydrolyzed product of collagen protein and has good water holding capacity, gelling and thermal reversibility, so it is widely used in the food industry. However, it has a low melting temperature and is prone to adhesion at high temperatures.

[0022] Glycerol has a small molecular size, a low glass transition temperature (-52°C), and a high ratio of hydroxyl groups to molecular weight in a single molecule, so it has good permeability. This application uses it as a plasticizer, mainly by inserting into the middle of a polymer molecular chain, reducing the intermolecular attraction between adjacent polymer chains, improving the mobility of polymer chains, and reducing the crystallinity of polymer molecular chains, thereby improving the elasticity and operability of the rubber and increasing its stretchability.

[0023] Pectin is a complex acidic heteropolysaccharide that is widely found in the primary cell walls of various higher terrestrial plants in nature and is often used in the food industry as a gelling agent, thickener, emulsifier, etc. The low-ester pectin and gelatin compound of the present application have good synergistic effects, because the positively charged gelatin and the anionic polysaccharide are combined together by electrostatics, generating a strong attraction to form a complex, and the charged pectin promotes the aggregation of gelatin molecules.

[0024] Agar is a widely used seaweed polysaccharide with extremely strong gelling ability. The gel formed is thermoreversible, but it has disadvantages such as high brittleness and easy dehydration shrinkage. Therefore, it needs to be used in combination with other colloids.

[0025] Locust bean gum is a linear galactomannan obtained from the endosperm of Robinia tree seeds. Locust bean gum has no gelling properties and has the characteristics of high viscosity at low concentrations. The locust bean gum-agar compounding principle of the present application: in the process of agar molecules aggregating to form a three-dimensional network, locust bean gum molecules participate in it, and the hydrogen bonding between the two molecules promotes the gelation process of the mixed gel system, thereby rapidly increasing the apparent viscosity of the composite solution. The skeleton structure mesh of the composite gel becomes smaller and denser, and the gel hardness, chewing resistance, and elasticity show a decreasing trend, but the cohesion shows an increasing trend.

[0026] In some embodiments of the present application, the above-mentioned enteric soft capsule composition is prepared by the following process: purified water, glycerin, pectin, locust bean gum and agar are heated and stirred, then gelatin is added, stirred until the gelatin is dissolved, and vacuumed to obtain a gelatin solution; the gelatin solution and the functional contents are pressed into soft capsules.

[0027] In some embodiments of the present application, the components of the enteric gum layer include gelatin, glycerin, purified water, gellan gum, carrageenan and xanthan gum.

[0028] In some embodiments of the present application, the components of the enteric gum layer are, by mass percentage, 38.5-41% gelatin, 16.2-19.2% glycerol, 36.3-39.75% purified water, 0.05-6.0% gellan gum, 0.2-2.5% carrageenan and 0.35-2.0% xanthan gum.

[0029] Gellan gum is an extracellular polysaccharide produced by Sphingomonas paucimobilis under aerobic fermentation conditions. It is a linear tetrasaccharide repeating unit polymer composed of glucose, glucuronic acid and rhamnose connected in a ratio of 2:1:1. Gellan gum can usually form a gel at a dosage of 0.05%, maintain a high gel strength and viscosity at 90°C, and remain stable in the pH range of 2 to 10, that is, it has the characteristics of low gel dosage, good stability, acid resistance and high temperature resistance.

[0030] Carrageenan, also known as carrageenan and stag bean gum, is a water-soluble colloid extracted from red algae and one of the world's three major algae industrial products (agar, carrageenan, and alginate). Gelatin as a base material for gel rubber has some shortcomings, such as: the rubber is greatly affected by temperature. Carrageenan shows stronger moisture resistance and thermal stability. The use of gelatin-carrageenan compound in this application can improve the temperature and moisture resistance of single gelatin rubber while also improving its thermal stability.

[0031] Xanthan gum is a polysaccharide extracted from the fermentation of Xanthomonas bacteria, also known as xanthan gum. Xanthan gum is soluble in water and can form a high-viscosity colloid at a low concentration (1%). Xanthan gum has multiple advanced structures in the solution: the side chains in the molecule are reversely wound around the main chain skeleton to form a helical structure, the molecules form a rod-shaped double helix structure through secondary forces, and then rely on weak forces to form a double helix mesh structure, which makes xanthan gum have a very strong ability to tolerate acid, alkali, salt and temperature. It maintains good viscosity within the appropriate pH range (4-10). Only under more extreme pH conditions (1-3 or 11-12) and at a concentration of 0.3%, its viscosity will change. Xanthan gum will show obvious synergistic effects after compounding with other hydrophilic colloids. This effect significantly increases the viscosity of the compound solution and can improve the acid resistance of a single gelatin rubber.

[0032] In some embodiments of the present application, the above-mentioned enteric soft capsule composition is prepared by the following process: purified water, glycerin, gellan gum, carrageenan and xanthan gum are heated and stirred, and then gelatin is added, stirred until the gelatin is dissolved, and vacuumed to obtain a gelatin solution; the gelatin solution and the functional contents are pressed into soft capsules.

[0033] In some embodiments of the present application, the heating temperature is 80-85°C.

[0034] The features and performance of the present application are further described in detail below in conjunction with the embodiments.

[0035] Example 1

[0036] A non-coated enteric soft capsule composition, which consists of an enteric gelatin layer and functional contents wrapped in the gelatin layer;

[0037] The components of the enteric gel cortex are gelatin 150 42.00%, glycerol 18.00%, purified water 39.30%, pectin 0.50%, locust bean gum 0.10% and agar 0.10%; the functional content is fish oil;

[0038] The preparation method is as follows: put purified water, glycerin, pectin, locust bean gum, and agar into Figure 1In the shown gelatinization equipment, heating and stirring, when the temperature rises to 80℃, gelatin is added, vacuumized, and cooking begins. Cook under negative pressure for 50min, and the vacuum degree must reach -0.05MPa. Stir and heat until the gelatin is completely dissolved. After the cooking is completed, vacuumize for 10min, and the vacuum degree reaches above -0.06MPa, and the glue liquid is ready for use; during the pill pressing process, the contents are filtered with 100 mesh, the pill pressing machine speed is 3.0rpm, and a 10# olive-shaped mold is used for pressing, and the rubber thickness range is 0.60-0.85mm. The glue liquid insulation temperature is 60.0℃, the gelatin box temperature is 65℃, the spray body temperature is 40.0℃, and the glue drum temperature is 20℃. The soft capsule pill press is used to press the glue liquid and the contents into soft capsules. After drying, soft capsules that meet the requirements are obtained. The moisture control range of the soft capsule rubber is: 8-15%. The qualified capsule has a smooth surface, no oil leakage, no deformation, no special-shaped pills, flat seams, and intact interfaces.

[0039] The soft capsules prepared in this example were tested for disintegration time according to the disintegration time test method of Chinese Pharmacopoeia 0921 and the enteric-coated capsule test method in capsules. The results were as follows: the soft capsules were tested in hydrochloric acid solution (9→1000) for 2 hours without a baffle, and there was no crack or disintegration in the capsule shell of each capsule; the baffle was added and tested in artificial intestinal fluid, and the capsules disintegrated for 15 minutes, which met the disintegration time standard for enteric-coated soft capsules.

[0040] Example 2

[0041] A non-coated enteric soft capsule composition, which consists of an enteric gelatin layer and functional contents wrapped in the gelatin layer;

[0042] The components of the enteric gel cortex are gelatin 150 41.00%, glycerin 18.00%, purified water 37.50%, pectin 2.00%, locust bean gum 0.50% and agar 1.00%; the functional content is fish oil;

[0043] The preparation method is as follows: put purified water, glycerin, pectin, locust bean gum and agar into a gelatinization container, heat and stir, and when the temperature rises to 85°C, put in gelatin, vacuumize and start cooking. Cook for 60 minutes under negative pressure, and the vacuum degree must reach -0.04MPa. Stir and heat until the gelatin is completely dissolved. After the cooking is completed, vacuumize for 12 minutes, and the vacuum degree reaches above -0.06MPa. The gelatin solution is ready for use; during the pill pressing process, the contents are filtered through 120 meshes, the pill pressing machine speed is 3.0rpm, and a 10# olive-shaped mold is used for pressing, and the thickness of the rubber skin ranges from 0.60 to 0.85mm. The gelatin solution insulation temperature is 65.0°C, the gelatin box temperature is 65°C, the spray body temperature is 38.0°C, and the rubber drum temperature is 23°C. The gelatin solution and the contents are pressed into soft capsules using a soft capsule pill press. After drying, soft capsules that meet the requirements are obtained. The moisture control range of the soft capsule rubber skin is: 8-15%. Qualified capsules have smooth surfaces, no oil leakage, no deformation, no special-shaped capsules, flat seams and intact interfaces.

[0044] The soft capsules prepared in this example were tested for disintegration time, and the results showed that the soft capsules were tested in hydrochloric acid solution (9→1000) for 2 hours without baffles, and each capsule shell had no cracks or disintegration; and the baffles were added and tested in artificial intestinal fluid, and the capsule shell disintegrated for 12 minutes, which met the disintegration standard of enteric-coated soft capsules.

[0045] Example 3

[0046] A non-coated enteric soft capsule composition, which consists of an enteric gelatin layer and functional contents wrapped in the gelatin layer;

[0047] The components of the enteric gel cortex are gelatin 150 40.00%, glycerin 18.00%, purified water 35.90%, pectin 4.00%, locust bean gum 0.10% and agar 2.00%; the functional content is fish oil;

[0048] The preparation method is as follows: put purified water, glycerin, pectin, locust bean gum and agar into a gelatinization container, heat and stir, and when the temperature rises to 85°C, put in gelatin, vacuumize and start cooking. Cook for 55 minutes under negative pressure, and the vacuum degree must reach -0.08MPa. Stir and heat until the gelatin is completely dissolved. After the cooking is completed, vacuumize for 5 minutes, and the vacuum degree reaches above -0.06MPa. The gelatin solution is ready for use; during the pill pressing process, the contents are filtered through 150 mesh, the pill pressing machine speed is 3.0rpm, and a 10# olive-shaped mold is used for pressing, and the thickness of the rubber skin ranges from 0.60 to 0.85mm. The temperature of the gelatin solution is 60°C, the temperature of the gelatin box is 60°C, the temperature of the spray body is 40.0°C, and the temperature of the rubber drum is 20°C. The gelatin solution and the contents are pressed into soft capsules using a soft capsule pill press. After drying, soft capsules that meet the requirements are obtained. The moisture control range of the soft capsule rubber skin is 8-15%. Qualified capsules have smooth surfaces, no oil leakage, no deformation, no special-shaped capsules, flat seams and intact interfaces.

[0049] The soft capsules prepared in this example were tested for disintegration time, and the results showed that the soft capsules were tested in hydrochloric acid solution (9→1000) for 2 hours without baffles, and each capsule shell had no cracks or disintegration; and the baffles were added and tested in artificial intestinal fluid, and the capsule shell disintegrated for 14 minutes, which met the disintegration standard of enteric-coated soft capsules.

[0050] Example 4

[0051] A non-coated enteric soft capsule composition, which consists of an enteric gelatin layer and functional contents wrapped in the gelatin layer;

[0052] The components of the enteric gel layer are gelatin 180 37.00%, glycerin 18.00%, purified water 36.50%, pectin 6.00%, locust bean gum 2.00% and agar 0.50%; the functional content is krill oil;

[0053] The preparation method is as follows: put purified water, glycerin, pectin, locust bean gum and agar into a gelatinization container, heat and stir, and when the temperature rises to 82°C, put in gelatin, vacuumize and start cooking. Cook under negative pressure for 55 minutes, and the vacuum degree must reach -0.06MPa. Stir and heat until the gelatin is completely dissolved. After the cooking is completed, vacuumize for 10 minutes, and the vacuum degree reaches above -0.06MPa. The gelatin solution is ready for use; during the pill pressing process, the contents are filtered through 100 mesh, the pill pressing machine speed is 3.0rpm, and a 10# olive-shaped mold is used for pressing, and the thickness of the rubber skin ranges from 0.60 to 0.85mm. The temperature of the gelatin solution is 60.0°C, the temperature of the gelatin box is 70°C, the temperature of the spray body is 42.0°C, and the temperature of the rubber drum is 18°C. The gelatin solution and the contents are pressed into soft capsules using a soft capsule pill press. After drying, soft capsules that meet the requirements are obtained. The moisture control range of the soft capsule rubber skin is 8-15%. Qualified capsules have smooth surfaces, no oil leakage, no deformation, no special-shaped capsules, flat seams and intact interfaces.

[0054] The soft capsules prepared in this example were tested for disintegration time, and the results showed that the soft capsules were tested in hydrochloric acid solution (9→1000) for 2 hours without baffles, and each capsule shell had no cracks or disintegration; and the baffles were added and tested in artificial intestinal fluid, and the capsule shell disintegrated for 14 minutes, which met the disintegration standard of enteric-coated soft capsules.

[0055] Example 5

[0056] A non-coated enteric soft capsule composition, which consists of an enteric gelatin layer and functional contents wrapped in the gelatin layer;

[0057] The components of the enteric gel cortex are gelatin 180 38.00%, glycerin 17.00%, purified water 35.00%, pectin 8.00%, locust bean gum 1.00% and agar 1.00%; the functional content is garlic oil;

[0058] The preparation method is as follows: put purified water, glycerin, pectin, locust bean gum and agar into a gelatinization container, heat and stir, and when the temperature rises to 80°C, put in gelatin, vacuumize and start cooking. Cook for 60 minutes under negative pressure, and the vacuum degree must reach -0.08MPa. Stir and heat until the gelatin is completely dissolved. After the cooking is completed, vacuumize for 12 minutes, and the vacuum degree reaches above -0.06MPa. The gelatin solution is ready for use; during the pill pressing process, the contents are filtered through 100 mesh, the pill pressing machine speed is 3.0rpm, and a 10# olive-shaped mold is used for pressing, and the thickness of the rubber skin ranges from 0.60 to 0.85mm. The gelatin solution insulation temperature is 60.0°C, the gelatin box temperature is 70°C, the spray body temperature is 38.0°C, and the rubber drum temperature is 23°C. The gelatin solution and the contents are pressed into soft capsules using a soft capsule pill press. After drying, soft capsules that meet the requirements are obtained. The moisture control range of the soft capsule rubber skin is: 8-15%. Qualified capsules have smooth surfaces, no oil leakage, no deformation, no special-shaped capsules, flat seams and intact interfaces.

[0059] The soft capsules prepared in this example were tested for disintegration time, and the results showed that the soft capsules were tested in hydrochloric acid solution (9→1000) for 2 hours without a baffle, and each capsule shell had no cracks or disintegration; and the baffle was added and tested in artificial intestinal fluid, and the capsule shell disintegrated for 16 minutes, which met the disintegration standard of enteric-coated soft capsules.

[0060] Comparative Example 1

[0061] A non-coated enteric soft capsule composition, which consists of an enteric gelatin layer and functional contents wrapped in the gelatin layer;

[0062] The components of the enteric gel layer are gelatin 150 36.00%, glycerin 16.00%, purified water 33.00%, pectin 10.00%, locust bean gum 2.50% and agar 2.50%; the functional content is krill oil;

[0063] The preparation method is as follows: put purified water, glycerin, pectin, locust bean gum, and agar into a gelatinization container, heat and stir, and when the temperature rises to 80°C, put in gelatin, evacuate, and start cooking. Cook under negative pressure for 50 minutes, and the vacuum degree must reach -0.06MPa. Stir and heat until the gelatin is completely dissolved. After the cooking is completed, evacuate for 10 minutes, and the vacuum degree reaches above -0.06MPa. The gelatin solution is ready for use; during the pill pressing process, the gelatin solution is too viscous to be pressed into pills, so qualified enteric soft capsules cannot be prepared.

[0064] Comparative Example 2

[0065] A non-coated enteric soft capsule composition, which consists of an enteric gelatin layer and a functional content wrapped in the gelatin layer; 42.00% gelatin 150, 18.00% glycerol, and 40.00% purified water; the functional content is krill oil;

[0066] The preparation method is as follows: the purified water and glycerol are heated and stirred, and when the temperature rises to 80°C, gelatin is added, vacuumized, and cooking is started. Cook under negative pressure for 60 minutes, and the vacuum degree needs to reach -0.06MPa. Stir and heat until the gelatin is completely dissolved. After the cooking is completed, vacuumize for 10 minutes, and the vacuum degree reaches above -0.06MPa, and the glue liquid is ready for use; during the pill pressing process, the contents are filtered through 100 mesh, the pill pressing machine speed is 3.0rpm, and a 10# olive-shaped mold is used for pressing, and the rubber thickness range is 0.60-0.85mm. The glue liquid insulation temperature is 60.0°C, the gelatin box temperature is 65°C, the spray body temperature is 40.0°C, and the glue drum temperature is 20°C. The glue liquid and the contents are pressed into soft capsules using a soft capsule pill press. After drying, soft capsules that meet the requirements are obtained. The moisture control range of the soft capsule rubber is 8-15%. The qualified capsule has a smooth surface, no oil leakage, no deformation, no special-shaped pills, flat seams, and intact interfaces.

[0067] The soft capsules prepared in this example were tested for disintegration time. The results showed that the soft capsules disintegrated in a hydrochloric acid solution (9→1000) for 10 min, which did not meet the disintegration standard of enteric-coated soft capsules.

[0068] Example 6

[0069] A non-coated enteric soft capsule composition, which consists of an enteric gelatin layer and functional contents wrapped in the gelatin layer;

[0070] The components of the enteric gel cortex are gelatin 150 41.00%, glycerin 17.20%, purified water 39.75%, gellan gum 0.05%, carrageenan 1.00% and xanthan gum 1.00%; the functional content is fish oil;

[0071] The preparation method is as follows: put purified water, glycerin, gellan gum, carrageenan and xanthan gum into a gelatinization container, heat and stir, and when the temperature rises to 82°C, put in gelatin, vacuumize and start cooking. Cook for 50 minutes under negative pressure, and the vacuum degree must reach -0.05MPa. Stir and heat until the gelatin is completely dissolved. After the cooking is completed, vacuumize for 10 minutes, and the vacuum degree reaches above -0.06MPa, and the glue liquid is ready for use; during the pill pressing process, the contents are filtered with 100 mesh, the pill pressing machine speed is 3.0rpm, and a 10# olive-shaped mold is used for pressing, and the thickness of the rubber skin ranges from 0.60 to 0.85mm. The glue liquid insulation temperature is 60.0°C, the gelatin box temperature is 65°C, the spray body temperature is 40.0°C, and the glue drum temperature is 20°C. The soft capsule pill press is used to press the glue liquid and the contents into soft capsules. After drying, soft capsules that meet the requirements are obtained. The moisture control range of the soft capsule rubber skin is: 8-15%. Qualified capsules have smooth surfaces, no oil leakage, no deformation, no special-shaped capsules, flat seams and intact interfaces.

[0072] The soft capsules prepared in this example were tested for disintegration time, and the results showed that the soft capsules were tested in hydrochloric acid solution (9→1000) for 2 hours without a baffle, and each capsule shell had no cracks or disintegration; and the baffle was added and tested in artificial intestinal fluid, and the capsule shell disintegrated for 16 minutes, which met the disintegration standard of enteric-coated soft capsules.

[0073] Example 7

[0074] A non-coated enteric soft capsule composition, which consists of an enteric gelatin layer and functional contents wrapped in the gelatin layer;

[0075] The components of the enteric gel layer are gelatin 150 40.00%, glycerin 17.20%, purified water 38.30%, gellan gum 0.50%, carrageenan 2.00% and xanthan gum 2.00%; the functional content is fish oil;

[0076] The preparation method is as follows: put purified water, glycerin, gellan gum, carrageenan and xanthan gum into a gelatinization container, heat and stir, and when the temperature rises to 80-85°C, put in gelatin, vacuumize and start cooking. Cook for 50 minutes under negative pressure, and the vacuum degree must reach -0.05MPa. Stir and heat until the gelatin is completely dissolved. After the cooking is completed, vacuumize for 10 minutes, and the vacuum degree reaches above -0.06MPa, and the glue liquid is ready for use; during the pill pressing process, the contents are filtered through 100 mesh, the pill pressing machine speed is 3.0rpm, and a 10# olive-shaped mold is used for pressing, and the thickness of the rubber skin ranges from 0.60 to 0.85mm. The glue liquid insulation temperature is 60.0°C, the gelatin box temperature is 65°C, the spray body temperature is 40.0°C, and the glue drum temperature is 20°C. The soft capsule pill press is used to press the glue liquid and the contents into soft capsules. After drying, soft capsules that meet the requirements are obtained. The moisture control range of the soft capsule rubber skin is: 8-15%. Qualified capsules have smooth surfaces, no oil leakage, no deformation, no special-shaped capsules, flat seams and intact interfaces.

[0077] The soft capsules prepared in this example were tested for disintegration time, and the results showed that the soft capsules were tested in hydrochloric acid solution (9→1000) for 2 hours without a baffle, and each capsule shell had no cracks or disintegration; and the baffle was added and tested in artificial intestinal fluid, and the capsule shell disintegrated for 13 minutes, which met the disintegration standard of enteric-coated soft capsules.

[0078] Example 8

[0079] A non-coated enteric soft capsule composition, which consists of an enteric gelatin layer and functional contents wrapped in the gelatin layer;

[0080] The components of the enteric gel cortex are gelatin 150 40.00%, glycerin 19.20%, purified water 38.30%, gellan gum 2.00%, carrageenan 0.20% and xanthan gum 0.30%; the functional content is fish oil;

[0081] The preparation method is as follows: put purified water, glycerin, gellan gum, carrageenan and xanthan gum into a gelatinization container, heat and stir, and when the temperature rises to 80-85°C, put in gelatin, vacuumize and start cooking. Cook for 50 minutes under negative pressure, and the vacuum degree must reach -0.05MPa. Stir and heat until the gelatin is completely dissolved. After the cooking is completed, vacuumize for 10 minutes, and the vacuum degree reaches above -0.06MPa, and the glue liquid is ready for use; during the pill pressing process, the contents are filtered through 100 mesh, the pill pressing machine speed is 3.0rpm, and a 10# olive-shaped mold is used for pressing, and the thickness of the rubber skin ranges from 0.60 to 0.85mm. The glue liquid insulation temperature is 60.0°C, the gelatin box temperature is 65°C, the spray body temperature is 40.0°C, and the glue drum temperature is 20°C. The soft capsule pill press is used to press the glue liquid and the contents into soft capsules. After drying, soft capsules that meet the requirements are obtained. The moisture control range of the soft capsule rubber skin is: 8-15%. Qualified capsules have smooth surfaces, no oil leakage, no deformation, no special-shaped capsules, flat seams and intact interfaces.

[0082] The soft capsules prepared in this example were tested for disintegration time, and the results showed that the soft capsules were tested in hydrochloric acid solution (9→1000) for 2 hours without baffles, and each capsule shell had no cracks or disintegration; and the baffles were added and tested in artificial intestinal fluid, and the capsule shell disintegrated for 18 minutes, which met the disintegration standard of enteric-coated soft capsules.

[0083] Example 9

[0084] A non-coated enteric soft capsule composition, which consists of an enteric gelatin layer and functional contents wrapped in the gelatin layer;

[0085] The components of the enteric gel layer are gelatin 150 39.00%, glycerin 16.20%, purified water 36.30%, gellan gum 4.00%, carrageenan 2.50% and xanthan gum 2.00%; the functional content is krill oil;

[0086] The preparation method is as follows: put purified water, glycerin, gellan gum, carrageenan and xanthan gum into a gelatinization container, heat and stir, and when the temperature rises to 82°C, put gelatin, vacuumize and start cooking. Cook for 50 minutes under negative pressure, and the vacuum degree must reach -0.07MPa. Stir and heat until the gelatin is completely dissolved. After the cooking is completed, vacuumize for 10 minutes, and the vacuum degree reaches above -0.06MPa, and the glue liquid is ready for use; during the pill pressing process, the contents are filtered with 100 mesh, the pill pressing machine speed is 3.0rpm, and a 10# olive-shaped mold is used for pressing, and the thickness of the rubber skin ranges from 0.60 to 0.85mm. The glue liquid insulation temperature is 60.0°C, the gelatin box temperature is 65°C, the spray body temperature is 40.0°C, and the glue drum temperature is 20°C. The soft capsule pill press is used to press the glue liquid and the contents into soft capsules. After drying, soft capsules that meet the requirements are obtained. The moisture control range of the soft capsule rubber skin is: 8-15%. Qualified capsules have smooth surfaces, no oil leakage, no deformation, no special-shaped capsules, flat seams and intact interfaces.

[0087] The soft capsules prepared in this example were tested for disintegration time, and the results showed that the soft capsules were tested in hydrochloric acid solution (9→1000) for 2 hours without a baffle, and each capsule shell had no cracks or disintegration; and the baffle was added and tested in artificial intestinal fluid, and the capsule shell disintegrated for 16 minutes, which met the disintegration standard of enteric-coated soft capsules.

[0088] Example 10

[0089] A non-coated enteric soft capsule composition, which consists of an enteric gelatin layer and functional contents wrapped in the gelatin layer;

[0090] The components of the enteric gel layer are gelatin 150 38.50%, glycerin 16.20%, purified water 36.30%, gellan gum 6.00%, carrageenan 1.50% and xanthan gum 1.50%; the functional content is garlic oil;

[0091] The preparation method is as follows: put purified water, glycerin, gellan gum, carrageenan and xanthan gum into a gelatinization container, heat and stir, and when the temperature rises to 80-85°C, put in gelatin, vacuumize and start cooking. Cook for 50 minutes under negative pressure, and the vacuum degree must reach -0.05MPa. Stir and heat until the gelatin is completely dissolved. After the cooking is completed, vacuumize for 10 minutes, and the vacuum degree reaches above -0.06MPa, and the glue liquid is ready for use; during the pill pressing process, the contents are filtered through 100 mesh, the pill pressing machine speed is 3.0rpm, and a 10# olive-shaped mold is used for pressing, and the thickness of the rubber skin ranges from 0.60 to 0.85mm. The glue liquid insulation temperature is 60.0°C, the gelatin box temperature is 65°C, the spray body temperature is 40.0°C, and the glue drum temperature is 20°C. The soft capsule pill press is used to press the glue liquid and the contents into soft capsules. After drying, soft capsules that meet the requirements are obtained. The moisture control range of the soft capsule rubber skin is: 8-15%. Qualified capsules have smooth surfaces, no oil leakage, no deformation, no special-shaped capsules, flat seams and intact interfaces.

[0092] The soft capsules prepared in this example were tested for disintegration time, and the results showed that the soft capsules were tested in hydrochloric acid solution (9→1000) for 2 hours without a baffle, and each capsule shell had no cracks or disintegration; and the baffles were added and tested in artificial intestinal fluid, and the capsule shell disintegrated for 13 minutes, which met the disintegration standard of enteric-coated soft capsules.

[0093] Comparative Example 3

[0094] A non-coated enteric soft capsule composition, which consists of an enteric gelatin layer and functional contents wrapped in the gelatin layer;

[0095] The components of the enteric gel layer are gelatin 150 36.50%, glycerin 16.20%, purified water 33.30%, gellan gum 8.00%, carrageenan 3.00% and xanthan gum 3.00%; the functional content is krill oil;

[0096] The preparation method is as follows: put purified water, glycerin, gellan gum, carrageenan, and xanthan gum into a gelatinization container, heat and stir, and when the temperature rises to 80-85°C, put in gelatin, evacuate, and start steaming. Steam under negative pressure for 60 minutes, and the vacuum degree must reach -0.06MPa. Stir and heat until the gelatin is completely dissolved. After steaming, evacuate for 12 minutes, and the vacuum degree reaches above -0.06MPa. The gelatin solution is ready for use. During the pill pressing process, the gelatin solution is too viscous to be pressed into pills, so qualified enteric soft capsules cannot be prepared.

[0097] The embodiments described above are part of the embodiments of the present application, rather than all of the embodiments. The detailed description of the embodiments of the present application is not intended to limit the scope of the present application for protection, but merely represents the selected embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without making creative work belong to the scope of protection of the present application.

Claims

1. A non-coated enteric soft capsule composition, characterized in that: The enteric soft capsule composition consists of an enteric rubber layer and functional contents wrapped in the rubber layer.

2. The uncoated enteric soft capsule composition according to claim 1, characterized in that: The functional contents include one or more of fish oil, krill oil, garlic oil, probiotic composition, and traditional Chinese medicine extract.

3. The uncoated enteric soft capsule composition according to claim 2, characterized in that: The components of the enteric gum layer include gelatin, glycerin, purified water, pectin, locust bean gum and agar.

4. The uncoated enteric soft capsule composition according to claim 3, characterized in that: In terms of mass percentage, the components of the enteric gum layer are 37-42% gelatin, 17-18% glycerol, 35-40% purified water, 0.5-8% pectin, 0.1-2.0% locust bean gum and 0.1-2.0% agar.

5. The uncoated enteric soft capsule composition according to claim 4, characterized in that: The enteric soft capsule composition is prepared by the following process: purified water, glycerin, pectin, locust bean gum and agar are heated and stirred, then gelatin is added, stirred until the gelatin is dissolved, and vacuumized to obtain gelatin solution; the gelatin solution and functional contents are pressed into soft capsules.

6. The uncoated enteric soft capsule composition according to claim 2, characterized in that: The components of the enteric gum layer include gelatin, glycerin, purified water, gellan gum, carrageenan and xanthan gum.

7. The uncoated enteric soft capsule composition according to claim 6, characterized in that: In terms of mass percentage, the components of the enteric rubber layer are 38.5-41% gelatin, 16.2-19.2% glycerol, 36.3-39.75% purified water, 0.05-6.0% gellan gum, 0.2-2.5% carrageenan and 0.35-2.0% xanthan gum.

8. The uncoated enteric soft capsule composition according to claim 7, characterized in that: The enteric soft capsule composition is prepared by the following process: purified water, glycerin, gellan gum, carrageenan and xanthan gum are heated and stirred, then gelatin is added, stirred until the gelatin is dissolved, and vacuumized to obtain gelatin solution; the gelatin solution and functional contents are pressed into soft capsules.

9. The uncoated enteric soft capsule composition according to claim 5 or 8, characterized in that: The heating temperature is 80-85°C.

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