Method for producing enteric soft capsules containing enzyme components and enteric soft capsules produced thereby

Abstract

The present invention relates to a method for manufacturing an enteric soft capsule containing an enzyme component and an enteric soft capsule manufactured thereby, wherein the enzyme component is contained in the soft coating material, thereby reducing the occurrence of denaturation due to gastric acid action and promoting dissolution efficiency in the intestine. The present invention for realizing this is characterized by comprising: a coating material preparation step (ST 1) of preparing a soft coating material comprising gelatin, glycerin, sorbitol, pectin, polyglycitol syrup, gellan gum, purified water, and enzymes; a mixing step (ST 2) of introducing the prepared coating material into a mixer and mixing it uniformly; a capsule molding step (ST 3) of molding the mixed coating material into a capsule shape and simultaneously injecting the contents; a drying step (ST 4) of drying the molded capsule for 3 to 10 days; and a sorting step (ST 5) of sorting the dried capsule for defects.

Description

Technology Field

[0001] The present invention relates to a method for manufacturing an enteric soft capsule, and more specifically, to a method for manufacturing an enteric soft capsule containing an enzyme component that does not dissolve in the stomach but reaches the intestines to maximize the efficacy of the drug contents, and to an enteric soft capsule manufactured thereby. Background Technology

[0003] Generally, people take medications and health functional foods to treat diseases or improve their health. The most common dosage form for these medications or health functional foods is the pill; pills can be broadly classified into tablets and capsules, while capsules can be divided into soft capsules and hard capsules.

[0004] Tablets are a form in which solidified medication is coated to dissolve and be absorbed within the body. Soft capsules are generally manufactured using gelatin, and are produced by placing active ingredients and additives between two sheets made of gelatin and molding them by applying pressure to the sheets. Therefore, soft capsules are formed as a single unit without any separation or cracks.

[0005] These soft capsules have the characteristic of not being broken down by stomach acid during the 2 hours they remain in the stomach and being broken down within 30 or 60 minutes in the intestines, but conventional enteric soft capsules had problems such as gaps forming as partial breakdown occurred due to contact with stomach acid. Prior art literature

[0007] Republic of Korea Patent Registration No. 2911489 (Registered Jan. 8, 2026) Republic of Korea Patent Registration No. 2864596 (Registered Sep. 22, 2025) Republic of Korea Patent Registration No. 1378974 (Registered Mar. 21, 2014) The problem to be solved

[0008] The present invention is proposed to improve upon the problems of the aforementioned conventional technology, and aims to provide a manufacturing technology for enteric soft capsules containing functional enzyme components that can improve the efficiency of reaching the intestines while minimizing decomposition caused by contact with stomach acid. means of solving the problem

[0010] The method for manufacturing a soft capsule according to the present invention for achieving the above objective comprises: a coating material preparation step of preparing a soft coating material comprising gelatin, glycerin, sorbitol, pectin, polyglycitol syrup, gellan gum, purified water, and an enzyme; a mixing step of introducing the prepared coating material into a mixer and mixing it uniformly; a capsule molding step of molding the mixed coating material into a capsule shape while simultaneously injecting the contents; a drying step of drying the molded capsule for 3 to 10 days; and a sorting step of sorting the dried capsule for defects. Effects of the invention

[0012] The method for manufacturing an enteric soft capsule according to the present invention has the effect of reducing the occurrence of degeneration of the capsule surface due to gastric acid action and promoting dissolution efficiency in the intestines, as the soft coating material contains an enzyme component.

[0013] In addition, it exhibits the advantage of improving ease of administration by making it easier to swallow through enhanced surface lubricity of the capsule. Brief explanation of the drawing

[0015] FIG. 1 is a flowchart of the process for manufacturing an enteric soft capsule according to one embodiment of the present invention. FIG. 2 is a photograph of an actual soft capsule manufactured according to the present invention. FIG. 3 is a flowchart of a soft capsule manufacturing process according to another embodiment of the present invention. Specific details for implementing the invention

[0016] Hereinafter, specific embodiments of the present invention will be examined in detail with reference to the attached drawings.

[0017] Embodiments of the present invention may be modified in various forms, and the scope of the present invention should not be interpreted as being limited to the embodiments described in detail below. These embodiments are provided to more fully explain the present invention to those with average knowledge in the art.

[0018] Accordingly, the shapes of components depicted in the drawings may be exaggerated to emphasize clearer explanations. It should be noted that identical components in each drawing may be illustrated with the same reference numeral. Furthermore, detailed descriptions of functions and configurations of known technology that are deemed to unnecessarily obscure the essence of the invention may be omitted.

[0019] First, the process of manufacturing an enteric soft capsule according to one embodiment of the present invention is as follows through the flowchart of FIG. 1.

[0020] <Film Material Preparation Step> (ST 1)

[0021] First, in the material preparation step, a soft coating material is prepared that includes gelatin, glycerin, sorbitol, pectin, polyglycitol syrup, gellan gum, purified water, and enzymes.

[0022] That is, at this time, the coating raw materials are weighed and prepared as follows: gelatin (pork skin) 25~35% by weight, glycerin (plasticizer) 10~20% by weight, sorbitol (plasticizer) 1~10% by weight, pectin (SPL) 1~5% by weight, polyglycitol syrup 0.5~3% by weight, gellan gum (LT-100) 0.01~0.05% by weight, purified water 30~45% by weight, and enzyme 0.1~5% by weight.

[0023] At this time, it is preferable that at least two enzymes among chymotrypsin, lipase, aminopeptidase, sucrase, and carboxypeptidase are selectively prepared as the enzyme in the present invention.

[0024] In particular, chymotrypsin promotes degradation in the intestines by enhancing protein degradation function, lipase and aminopeptidase enhance hydrolysis function, and carboxypeptidase performs the function of improving absorption efficiency in the form of glucose in the small intestine.

[0025] In addition, to increase manufacturing efficiency, the above-mentioned weighed enzyme is placed in a vacuum tank having a temperature of 35 to 45°C and stored for 1 hour to 1 hour and 30 minutes, thereby enhancing the stabilization function that allows the enzyme's activity to be maintained for a long period, and then mixing is performed in the next step.

[0026] <Mixing Step>(ST 2)

[0027] Subsequently, the prepared coating material is fed into a mixer and a process of uniform mixing is carried out.

[0028] At this time, purified water, gellan gum, and polyglycitol syrup are first added to a mixing tank maintained at a temperature of 85 to 95°C and heated, and then gelatin, glycerin, pectin, and enzymes are sequentially added and mixed, and stirring is performed using a stirrer. It is preferable to add the above materials and mix them for 30 to 40 minutes, and then perform degassing treatment.

[0029] In addition, during the stirring process, a vacuum state is maintained for a certain period (5 to 10 minutes) after stirring with a unidirectional stirrer, and then reverse stirring is performed to improve the stirring efficiency between the mixed materials.

[0030] Meanwhile, in the mixing step of the present invention, polyvinylpyrrolidone, trehalose, citrate, and almaget components for film properties and the catalytic function of the enzyme may each be additionally mixed in an amount of 1 to 5 parts by weight based on 100 parts by weight of the enzyme.

[0031] At this time, the mixed polyvinylpyrrolidone promotes enzyme activation due to its characteristics as a water-soluble polymer with a molecular weight of 30,000 to 40,000, trehalose and citrate perform the function of improving the lubricity and transparency of the film, and almaget performs the function of neutralizing stomach acid.

[0032] <Capsule Forming Step> (ST 3)

[0033] Subsequently, the film material mixed as described above is molded into a capsule shape, and the contents are injected simultaneously.

[0034] That is, at this time, the capsule contents material prepared through a separate process and the coating material are each fed into a known soft capsule molding machine, and the capsule contents are contained within the capsule coating material that is being formed into a sheet, and then cut and sealed to form a soft capsule formulation having a certain size.

[0035] At this time, it is preferable to store the capsule contents in a capsule contents storage tank and keep them warm by maintaining a temperature of 45 to 55°C to ensure smooth supply and prevent hardening, and to store the capsule coating material in a capsule coating material storage tank and keep it warm by maintaining a temperature of 55 to 65°C to ensure smooth supply and prevent hardening.

[0036] Here, the soft capsule molding machine uses a known device that supplies the capsule coating material to a pair of rotatingly driven molding rolls while forming it into a sheet and inserts the capsule contents. Here, the soft capsule is molded to a size filled with 150 mg to 1,200 mg of capsule contents so that it is easy for an adult to consume.

[0037] <Drying Stage>(ST 4)

[0038] Afterwards, a drying process is carried out for 3 to 10 days for the capsules produced by the above molding process.

[0039] In other words, the drying step at this stage is carried out in a drying chamber, and it is preferable to perform the drying process for 24 to 48 hours under conditions maintaining a temperature of 15 to 20°C and a humidity of 25 to 30% to increase the drying efficiency of the molded soft capsules.

[0040] <Selection Stage>(ST 5)

[0041] Subsequently, a sorting process is carried out to identify whether the dried capsules are defective.

[0042] At this time, the dried soft capsule is fed into a sorter to separate non-standard products, thereby obtaining a good quality enteric soft capsule (10) as shown in Fig. 2.

[0043] The enteric soft capsule of the present invention, manufactured through such a process, exhibits the effect of reducing the occurrence of denaturation of the capsule surface due to gastric acid action and promoting dissolution efficiency in the intestines, as the soft coating material contains an enzyme component.

[0044] In particular, the functionality of the enzyme can be improved by mixing two or more complex enzymes, and the stabilization function can be improved by storing the enzyme in a vacuum tank before mixing.

[0045] In addition, it exhibits the advantage of improving ease of administration by making it easier to swallow through enhanced surface lubricity of the capsule.

[0047] Meanwhile, FIG. 3 shows a manufacturing process according to another embodiment of the present invention, wherein after the molding step (ST 3), a lubricating coating agent spraying step (ST 3-1) is additionally performed to form a thin film lubricating layer to improve the lubricity of the capsule surface.

[0048] At this time, it is preferable that the sprayed lubricating coating agent has a mixed composition in the ratio of 30-45% by weight of deionized water, 10-30% by weight of triglyceride, 5-20% by weight of sunflower oil, 10-20% by weight of capric triglyceride, 10-15% by weight of magnesium stearate, 1-10% by weight of cellulose acetate phthalate (CAP), and 5-10% by weight of ascorbyl palmitate.

[0049] When such a lubricating coating agent is sprayed, a lubricating coating layer is formed on the surface of the soft capsule in the form of a fine film, resulting in the advantage of smoother swallowing due to improved surface lubricity.

[0050] In particular, the lubricating coating agent contains triglyceride components, which are fatty acid derivatives, to improve the absorption efficiency of the capsule surface, and contains capric triglyceride and sunflower oil components to maximize lubrication efficiency, magnesium stearate improves coating stability by enhancing the adhesive function of the coating agent, and cellulose acetate phthalate and ascorbyl palmitate each improve the transparency of the coating layer and prevent discoloration through the catalytic function of deionized water.

[0052] Furthermore, although specific embodiments of the present invention have been described and illustrated above, it is obvious that the soft capsule manufacturing process of the present invention can be implemented with various modifications by those skilled in the art.

[0053] However, such modified embodiments should not be understood separately from the technical spirit or scope of the present invention, and such modified embodiments should be considered to be included within the appended claims of the present invention. Explanation of the symbols

[0055] 10 : Soft capsules

Claims

Claim 1 A coating material preparation step (ST 1) for preparing a soft coating material comprising gelatin, glycerin, sorbitol, pectin, polyglycitol syrup, gellan gum, purified water, and enzymes; a mixing step (ST 2) for introducing the prepared coating material into a mixer and mixing it uniformly; a capsule molding step (ST 3) for molding the mixed coating material into a capsule shape and simultaneously injecting the contents; a drying step (ST 4) for drying the molded capsules for 3 to 10 days; and a sorting step (ST 5) for sorting the dried capsules for defects; wherein the enzymes prepared in the coating material preparation step (ST 1) are selectively prepared from at least two enzymes among chymotrypsin, lipase, aminopeptidase, sucrase, and carboxypeptidase, and the enzymes prepared in the coating material preparation step (ST 1) are introduced into a vacuum tank having a temperature of 35 to 45°C for stabilization A method for manufacturing an enteric soft capsule containing an enzyme component, wherein the capsule is stored for 1 hour to 1 hour 30 minutes, then mixed with other materials in a mixing step (ST 2), and after the molding step (ST 3), a lubricating coating agent spraying step (ST 3-1) is additionally performed to form a thin lubricating layer to improve the lubricity of the capsule surface, wherein the lubricating coating agent is characterized by having a mixed composition of deionized water, triglycerides, sunflower oil, capric triglycerides, magnesium stearate, cellulose acetate phthalate, and ascorbyl palmitate. Claim 2 delete Claim 3 delete Claim 4 A method for manufacturing an enteric soft capsule containing an enzyme component according to claim 1, characterized in that in the mixing step (ST 2), polyvinylpyrrolidone, trehalose, citrate, and almagate components are additionally mixed in an amount of 1 to 5 parts by weight based on 100 parts by weight of the enzyme. Claim 5 delete Claim 6 An enteric soft capsule containing an enzyme component, characterized by being manufactured by the method of either claim 1 or claim 4.

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