Soft capsule material and its preparation method and soft capsule

Abstract

This invention relates to the field of soft capsule technology, and particularly to a soft capsule material, its preparation method, and soft capsules. The soft capsule material comprises the following components in parts by weight: 3-25 parts modified zinc oxide, 30-100 parts plasticizer, and 40-150 parts gelling agent; wherein the modified zinc oxide comprises zinc oxide and a modifier, the weight ratio of zinc oxide to the modifier being (1-19):1, and the mesh size of the zinc oxide being 120-3000 mesh. The soft capsule material of this invention has light-blocking properties, stable color, and no food safety issues.

Description

Technical Field

[0001] This invention relates to the field of soft capsule technology, and in particular to a soft capsule material, its preparation method, and a soft capsule. Background Technology

[0002] Soft capsules are a dosage form that disintegrates rapidly, has high bioavailability, and is easy to store and carry. For light-sensitive and unstable drugs, they can be filled into opaque capsules to prevent the effects of moisture, oxygen in the air, or light on the drug, thereby improving its stability.

[0003] Titanium dioxide (TiO2) is opaque, with good whiteness and gloss, and was widely used as a white food pigment in the past, not only in the food industry but also in flexible capsules for whitening and light-blocking effects. However, the application of titanium dioxide is limited by two main factors: First, flexible capsules contain gelling agents. When titanium dioxide and gelling agents coexist for extended periods, titanium dioxide, due to its photochemical activity, generates oxygen atoms under light excitation in the presence of air and water. This strong oxidizing property degrades organic media and promotes browning of the gelling agent, i.e., the Maillard reaction, causing the flexible capsule to turn yellow. When the flexible capsule contains pigments such as caramel coloring, fading may also occur. Second, in recent years, the safety of titanium dioxide has been increasingly questioned. In 2020, the European Commission adopted Regulation (EC) 1272 / 2008, classifying titanium dioxide as a Group 2 suspected carcinogen, which may cause cancer through inhalation. Titanium dioxide was officially banned throughout Europe on August 7, 2022, and is no longer authorized as a food additive.

[0004] It is evident that soft capsule materials currently still have the problem of not being able to stably and safely perform their light-blocking function. Summary of the Invention

[0005] Based on this, the present invention provides a soft capsule material, its preparation method, and a soft capsule to solve the problem that soft capsule materials cannot stably and safely perform their light-blocking function.

[0006] The first aspect of this invention provides a soft capsule material, the technical solution of which is as follows:

[0007] A soft capsule material comprising the following components in parts by weight:

[0008] 3-25 parts modified zinc oxide, 30-100 parts plasticizer and 40-150 parts gelling agent;

[0009] The modified zinc oxide comprises zinc oxide and a modifier, wherein the weight ratio of zinc oxide to modifier is (1~19):1, and the mesh size of zinc oxide is 120 mesh to 3000 mesh.

[0010] In some embodiments, the soft capsule material comprises the following components in parts by weight:

[0011] 10-25 parts modified zinc oxide, 40-60 parts plasticizer and 90-110 parts gelling agent.

[0012] In some embodiments, the weight ratio of zinc oxide to modifier is (1~15):1.

[0013] In some embodiments, the weight ratio of zinc oxide to modifier is (1~7):1.

[0014] In some embodiments, the modifier is modified starch.

[0015] In some embodiments, the modified starch is selected from one or more of acid-treated starch, acetate starch, and hydroxypropyl starch.

[0016] In some embodiments, the plasticizer is selected from one or more of glycerol, sorbitol, and polyethylene glycol.

[0017] In some embodiments, the gelling agent is selected from one or more of starch, gelatin, carrageenan, and gellan gum.

[0018] In some embodiments, colorants and / or flavoring agents are also included.

[0019] In some embodiments, the weight ratio of the modified zinc oxide to the colorant is (3~25):(0.01~10); and / or

[0020] The weight ratio of the modified zinc oxide to the flavoring agent is (3~25):(0.01~10).

[0021] In some embodiments, the colorant is selected from one or more of caramel coloring, lemon yellow coloring, allure red coloring, and brilliant blue coloring.

[0022] In some embodiments, the flavoring agent is selected from one or more of sugar alcohols, glycosides, flavorings, fragrances, fruit juices, and fruit powders.

[0023] In some embodiments, water is also included, wherein the water accounts for 5 wt% to 20 wt% of the mass of the soft capsule material.

[0024] The second aspect of this invention provides a method for preparing a soft capsule material, the technical solution of which is as follows:

[0025] A method for preparing a soft capsule material includes the following steps:

[0026] The modified zinc oxide is prepared by mixing the zinc oxide and the modifier;

[0027] A modified zinc oxide suspension is prepared by mixing a portion of the plasticizer with the modified zinc oxide.

[0028] A transparent adhesive solution is prepared using the remaining plasticizer and gelling agent;

[0029] The modified zinc oxide suspension and the transparent adhesive were mixed to prepare the adhesive solution;

[0030] The soft capsule material is prepared using the adhesive solution.

[0031] A third aspect of the present invention provides a soft capsule comprising contents and a soft capsule material covering the contents, the soft capsule material being described above.

[0032] Compared with traditional solutions, the present invention has the following advantages:

[0033] The flexible capsule material of this invention incorporates modified zinc oxide, which includes zinc oxide and a modifier. Compared to titanium dioxide, modified zinc oxide is chemically less reactive and is less likely to react with gelling agents in air, water, and light environments over extended periods, thus reducing the likelihood of yellowing or fading and contributing to color stability. Furthermore, modified zinc oxide has the potential to meet the whiteness and light-blocking requirements of flexible capsule materials. Moreover, modified zinc oxide poses no food safety concerns. This invention involves blending modified zinc oxide, plasticizer, and gelling agent in appropriate proportions to obtain a flexible capsule material with good light-blocking properties, high whiteness, stable color, and good food safety. In summary, the flexible capsule material of this invention provides light-blocking functionality, stable color, and eliminates food safety concerns. Detailed Implementation

[0034] The present invention will be further described in detail below with reference to specific embodiments. The present invention can be implemented in many different forms and is not limited to the embodiments described herein. Rather, these embodiments are provided to provide a thorough and complete understanding of the disclosure of the present invention.

[0035] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.

[0036] the term

[0037] Unless otherwise stated or in case of contradiction, the terms or phrases used herein shall have the following meanings:

[0038] In this invention, the selection range of "and / or", "or / and", and "and / or" includes any one of two or more related listed items, as well as any and all combinations of the related listed items. These arbitrary and all combinations include any two related listed items, any more related listed items, or a combination of all related listed items. It should be noted that when at least three items are connected using at least two conjunctions selected from "and / or", "or / and", and "and / or", it should be understood that the technical solution undoubtedly includes technical solutions connected by "logical AND", and also undoubtedly includes technical solutions connected by "logical OR". For example, "A and / or B" includes three parallel solutions: A, B, and A+B. For example, the technical solution of "A, and / or, B, and / or, C, and / or, D" includes any one of A, B, C, and D (that is, a technical solution that is connected by "logical OR"), as well as any and all combinations of A, B, C, and D, that is, combinations of any two or three of A, B, C, and D, and also combinations of all four of A, B, C, and D (that is, a technical solution that is connected by "logical AND").

[0039] In this invention, terms such as "multiple", "various", "multiple times", and "multi-dimensional" are used, unless otherwise specified, to refer to a quantity greater than or equal to 2. For example, "one or more" means one or more types.

[0040] In this invention, the terms "optionally," "optionally," and "optional" refer to options that are optional, meaning they are selected from either "with" or "without." If multiple "optional" options appear in a technical solution, unless otherwise specified and there are no contradictions or mutual constraints, each "optional" option is independent.

[0041] In this invention, the terms "first aspect," "second aspect," "third aspect," and "fourth aspect," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance or quantity, nor should they be construed as implicitly indicating the importance or quantity of the indicated technical features. Moreover, "first," "second," "third," and "fourth," etc., serve only as a non-exhaustive enumeration and should be understood not to constitute a closed limitation on quantity.

[0042] In this invention, numerical intervals (i.e., numerical ranges) are involved. Unless otherwise specified, the selected numerical distributions within the aforementioned numerical intervals are considered continuous, and include the two endpoints (i.e., the minimum and maximum values) of the numerical range, as well as every value between these two endpoints. Unless otherwise specified, when a numerical interval refers only to integers within that interval, it includes the two endpoint integers of the numerical range, as well as every integer between the two endpoints. In this document, this is equivalent to directly listing every integer. For example, if t is an integer selected from 1 to 10, it means that t is any integer selected from the group of integers consisting of 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10. Furthermore, when multiple ranges are provided to describe features or characteristics, these ranges can be merged. In other words, unless otherwise specified, the ranges disclosed herein should be understood to include any and all subranges included therein.

[0043] Unless otherwise specified, the temperature parameters in this invention can be either constant temperature treatment or variations within a certain temperature range. It should be understood that the constant temperature treatment allows temperature fluctuations within the precision range controlled by the instrument. Fluctuations are permitted within ranges such as ±5℃, ±4℃, ±3℃, ±2℃, and ±1℃.

[0044] To address the problem that titanium dioxide, when used in flexible capsule materials, cannot stably and safely enable the flexible capsule to perform its light-shielding function, the first aspect of this invention provides a flexible capsule material. In one embodiment, the flexible capsule material comprises the following components in parts by weight:

[0045] 3-25 parts modified zinc oxide, 30-100 parts plasticizer and 40-150 parts gelling agent;

[0046] The modified zinc oxide comprises zinc oxide and a modifier, wherein the weight ratio of zinc oxide to modifier is (1~19):1, and the mesh size of zinc oxide is 120 mesh to 3000 mesh.

[0047] The soft capsule material of this embodiment incorporates modified zinc oxide, which includes zinc oxide and a modifier. Compared to titanium dioxide, modified zinc oxide is chemically less reactive and is less likely to react with the gelling agent in air, water, and light exposure for extended periods, thus reducing the likelihood of yellowing or fading of the soft capsule material and promoting color stability. Simultaneously, modified zinc oxide has the potential to meet the whiteness and light-blocking requirements of soft capsule materials. Furthermore, modified zinc oxide poses no food safety concerns. This embodiment involves blending modified zinc oxide, a plasticizer, and a gelling agent in appropriate proportions to obtain a soft capsule material with good light-blocking properties, high whiteness, stable color, and good food safety. In summary, the soft capsule material of this invention provides light-blocking functionality, stable color, and eliminates food safety concerns.

[0048] In this embodiment, the weight ratio of zinc oxide to the modifier is (1~19):1. It is understood that the weight ratio of zinc oxide to the modifier includes, but is not limited to, 1:1, 3:1, 5:1, 7:1, 9:1, 11:1, 13:1, 15:1, 17:1, and 19:1. Preferably, the weight ratio of zinc oxide to the modifier is (1~15):1. More preferably, the weight ratio of zinc oxide to the modifier is (1~10):1. Even more preferably, the weight ratio of zinc oxide to the modifier is (1~7):1. Even more preferably, the weight ratio of zinc oxide to the modifier is (2~6):1.

[0049] In this embodiment, the zinc oxide has a mesh size of 120 to 3000 mesh. It can be understood that the mesh size of the zinc oxide includes, but is not limited to, 120 mesh, 300 mesh, 600 mesh, 1500 mesh, and 3000 mesh.

[0050] Optionally, the modifier is modified starch.

[0051] Further optionally, the modified starch is selected from one or more of acid-treated starch, acetate starch, and hydroxypropyl starch.

[0052] The modified zinc oxide described above can replace titanium dioxide in flexible packaging materials. It has the potential to meet the requirement of a white, opaque appearance, and its color stability is superior to titanium dioxide. It does not require light-protected storage, and the packaging material is no longer limited; both opaque and transparent bottles can be used. Furthermore, in terms of food safety, it can be promoted and applied in the EU, Canada, the US, and China markets, meeting the needs of the international market environment.

[0053] Understandably, the modified zinc oxide is present in parts by weight, including but not limited to 3 parts, 8 parts, 12 parts, 15 parts, 16 parts, 20 parts, 24 parts, and 25 parts. Preferably, the modified zinc oxide is present in parts by weight of 10 to 25 parts.

[0054] The plasticizer is present in parts by weight, including but not limited to 30, 40, 45, 50, 60, 70, 80, 90, and 100 parts. Preferably, the plasticizer is present in parts by weight of 40 to 60 parts.

[0055] The gelling agent is available in parts by weight, including but not limited to 40, 60, 80, 90, 100, 120, 140, and 150 parts. Preferably, the gelling agent is available in parts by weight of 90 to 110 parts.

[0056] Optionally, the soft capsule material comprises the following components in parts by weight:

[0057] 10-25 parts modified zinc oxide, 40-60 parts plasticizer and 90-110 parts gelling agent.

[0058] Optionally, the plasticizer is selected from one or more of glycerol, sorbitol and polyethylene glycol.

[0059] Optionally, sorbitol can be provided by sorbitol liquid, wherein the weight percentage of sorbitol in the sorbitol liquid can be 40wt% to 80wt%.

[0060] Optionally, the gelling agent is selected from one or more of starch, gelatin, carrageenan, and gellan gum.

[0061] Optionally, the flexible capsule material also includes a colorant. When the flexible capsule material does not contain a colorant, it is opaque white and does not easily yellow after prolonged exposure to air and water or light, exhibiting stable color. When the flexible capsule material contains a colorant, it exhibits a specific color and does not easily fade after prolonged exposure to air and water or light. Optionally, the weight ratio of the modified zinc oxide to the colorant is (3~25):(0.01~10).

[0062] Optionally, the soft capsule material further includes a flavoring agent. Optionally, the weight ratio of the modified zinc oxide to the flavoring agent is (3~25):(0.01~10).

[0063] Optionally, the colorant is selected from one or more of caramel coloring, lemon yellow coloring, allure red coloring, and brilliant blue coloring.

[0064] Optionally, the flavoring agent is selected from one or more of sugar alcohols, glycosides, flavorings, fragrances, fruit juices, and fruit powders.

[0065] Optionally, the soft capsule material also includes water, wherein the water accounts for 5 wt% to 20 wt% of the mass of the soft capsule material.

[0066] A second aspect of the present invention provides a method for preparing the above-mentioned soft capsule material. In one embodiment, the method for preparing the soft capsule material includes the following steps:

[0067] The modified zinc oxide is prepared by mixing the zinc oxide and the modifier;

[0068] A modified zinc oxide suspension is prepared by mixing a portion of the plasticizer with the modified zinc oxide.

[0069] A transparent adhesive solution is prepared using the remaining plasticizer and gelling agent;

[0070] The modified zinc oxide suspension and the transparent adhesive were mixed to prepare the adhesive solution;

[0071] The soft capsule material is prepared using the adhesive solution.

[0072] Optionally, the zinc oxide and the modifier are mixed in a mixer. Further optionally, the mixing speed is 5 rpm to 20 rpm, and the mixing time is 10 min to 30 min.

[0073] When the plasticizer is liquid, the step of preparing a modified zinc oxide suspension by mixing a portion of the plasticizer with the modified zinc oxide includes the following steps: mixing a portion of the plasticizer with the modified zinc oxide to obtain a modified zinc oxide suspension.

[0074] When the plasticizer is solid, the step of preparing a modified zinc oxide suspension by mixing a portion of the plasticizer with the modified zinc oxide includes the following steps: a portion of the plasticizer can be dissolved in water first, and then mixed with the modified zinc oxide to obtain a modified zinc oxide suspension.

[0075] Optionally, the mass of plasticizer used in the mixed zinc oxide is equal to the mass of zinc oxide.

[0076] Understandably, mixing modified zinc oxide with a plasticizer also includes the step of filtering the resulting suspension.

[0077] Optionally, the preparation of the transparent adhesive using the remaining portion of the plasticizer and gelling agent includes the following steps: mixing the remaining portion of the plasticizer, gelling agent and water, heating until the gelling agent is completely dissolved, to obtain the transparent adhesive.

[0078] Optionally, the system temperature is heated to 70°C to 90°C.

[0079] When the soft capsules also include flavoring agents, the flavoring agents are mixed with water and added to a mixture of plasticizer, gelling agent and water, and then heated to prepare a transparent adhesive solution.

[0080] When the soft capsule also includes a colorant, the colorant is added to the mixture of modified zinc oxide suspension and transparent adhesive to adjust the color and prepare the adhesive.

[0081] Optionally, the preparation of the soft capsule material using the adhesive solution includes the following steps:

[0082] The adhesive solution is coated and dried to obtain a soft capsule material.

[0083] Understandably, the application of adhesive is accomplished using an adhesive spreader.

[0084] Optionally, the material is dried until the water content in the soft capsule material is 5 wt% to 20 wt%.

[0085] A third aspect of the present invention provides a soft capsule, in one embodiment of which the soft capsule includes contents and a soft capsule material covering the contents, the soft capsule material being described above.

[0086] The soft capsule of this embodiment has all the advantages of the soft capsule material described above, which will not be repeated here.

[0087] The following description is further illustrated with specific embodiments and comparative examples. Unless otherwise specified, the raw materials involved in the following specific embodiments and comparative examples are all commercially available. Unless otherwise specified, the instruments used are all commercially available. Unless otherwise specified, the processes involved are conventionally selected by those skilled in the art.

[0088] Preparation method of soft capsule material

[0089] Method 1:

[0090] (1) Preparation of modified zinc oxide: Zinc oxide and modified starch were put into a mixer, the mixing speed was set to 10 rpm, and the mixture was mixed for 20 min. After the mixing was completed, the mixture was discharged and set aside for later use.

[0091] (2) Preparation of modified zinc oxide suspension: Mix modified zinc oxide with an equal mass of plasticizer, stir evenly, filter, and obtain modified zinc oxide suspension for later use;

[0092] (3) Preparation of transparent adhesive solution: Mix the remaining plasticizer, purified water and gelling agent, heat to 70-80℃ until the gelling agent is completely dissolved to obtain transparent adhesive solution for later use;

[0093] (4) Preparation of the adhesive solution: Add the modified zinc oxide suspension to the transparent adhesive solution, stir and adjust the color to obtain the adhesive solution;

[0094] (5) Preparation of soft capsule material: Take an appropriate amount of adhesive liquid and inject it into the adhesive spreader. After spreading the adhesive, dry it until the mass ratio of water in the soft capsule material is 5wt%~20wt%.

[0095] Method 2:

[0096] (1) Preparation of transparent adhesive solution: Mix plasticizer, purified water and gelling agent, heat to 70-80℃ until the gelling agent is completely dissolved to obtain transparent adhesive solution for later use;

[0097] (2) Preparation of soft capsule material: Take an appropriate amount of transparent adhesive liquid and inject it into the adhesive spreader. After spreading the adhesive, dry it until the mass ratio of water in the soft capsule material is 5wt%~20wt%.

[0098] Method 3:

[0099] (1) Preparation of titanium dioxide suspension: Titanium dioxide is mixed with an equal mass of plasticizer, stirred evenly, filtered, and titanium dioxide suspension is obtained for later use;

[0100] (2) Preparation of transparent adhesive solution: Mix the remaining plasticizer, purified water and gelling agent, heat to 70-80℃ until the gelling agent is completely dissolved to obtain transparent adhesive solution for later use;

[0101] (3) Preparation of adhesive solution: Add titanium dioxide suspension to transparent adhesive solution, stir and adjust color to obtain adhesive solution;

[0102] (4) Preparation of soft capsule material: Take an appropriate amount of adhesive liquid and inject it into the adhesive spreader. After spreading the adhesive, dry it until the mass ratio of water in the soft capsule material is 5wt%~20wt%.

[0103] Method 4:

[0104] (1) Preparation of zinc oxide / modified starch suspension: Zinc oxide / modified starch is mixed with an equal mass of plasticizer, stirred evenly, filtered, and zinc oxide / modified starch suspension is obtained for later use;

[0105] (2) Preparation of transparent adhesive solution: Mix the remaining plasticizer, purified water and gelling agent, heat to 70-80℃ until the gelling agent is completely dissolved to obtain transparent adhesive solution for later use;

[0106] (3) Preparation of adhesive solution: Add zinc oxide suspension or modified starch suspension to transparent adhesive solution, stir and adjust the color to obtain adhesive solution;

[0107] (4) Preparation of soft capsule material: Take an appropriate amount of adhesive liquid and inject it into the adhesive spreader. After spreading the adhesive, dry it until the mass ratio of water in the soft capsule material is 5wt%~20wt%.

[0108] Method 5:

[0109] (1) Preparation of zinc oxide / titanium dioxide suspension: Zinc oxide / titanium dioxide is mixed with an equal mass of plasticizer, stirred evenly, filtered, and zinc oxide / titanium dioxide suspension is obtained for later use;

[0110] (2) Preparation of transparent adhesive solution: Mix the remaining plasticizer, purified water and gelling agent, heat to 70-80℃ until the gelling agent is completely dissolved to obtain transparent adhesive solution for later use;

[0111] (3) Preparation of adhesive solution: Add zinc oxide suspension and titanium dioxide suspension to transparent adhesive solution in sequence, stir and adjust the color to obtain adhesive solution;

[0112] (4) Preparation of soft capsule material: Take an appropriate amount of adhesive liquid and inject it into the adhesive spreader. After spreading the adhesive, dry it until the mass ratio of water in the soft capsule material is 5wt%~20wt%.

[0113] Method Six:

[0114] (1) Preparation of modified titanium dioxide / calcium carbonate / magnesium oxide: Titanium dioxide / calcium carbonate / magnesium oxide and modified starch were put into a mixer, the mixing speed was set to 10 rpm, and the mixture was mixed for 20 min. After the mixing was completed, the mixture was discharged and set aside for later use.

[0115] (2) Preparation of modified titanium dioxide / calcium carbonate / magnesium oxide suspension: Mix the modified titanium dioxide / calcium carbonate / magnesium oxide with an equal mass of plasticizer, stir evenly, filter, and obtain the modified titanium dioxide / calcium carbonate / magnesium oxide suspension for later use;

[0116] (3) Preparation of transparent adhesive solution: Mix the remaining plasticizer, purified water and gelling agent, heat to 70-80℃ until the gelling agent is completely dissolved to obtain transparent adhesive solution for later use;

[0117] (4) Preparation of adhesive solution: Add modified titanium dioxide suspension, calcium carbonate suspension or magnesium oxide suspension to transparent adhesive solution, stir and adjust the color to obtain adhesive solution;

[0118] (5) Preparation of soft capsule material: Take an appropriate amount of adhesive liquid and inject it into the adhesive spreader. After spreading the adhesive, dry it until the mass ratio of water in the soft capsule material is 5wt%~20wt%.

[0119] Method Seven:

[0120] (1) Preparation of modified zinc oxide: Zinc oxide and modified starch were put into a mixer, the mixing speed was set to 10 rpm, and the mixture was mixed for 20 min. After the mixing was completed, the mixture was discharged and set aside for later use.

[0121] (2) Preparation of modified zinc oxide suspension: Mix modified zinc oxide with an equal mass of plasticizer, stir evenly, filter, and obtain modified zinc oxide suspension for later use;

[0122] (3) Preparation of transparent adhesive solution: Mix the remaining plasticizer, purified water and gelling agent, heat to 70-80℃ until the gelling agent is completely dissolved to obtain transparent adhesive solution for later use;

[0123] (4) Preparation of adhesive solution: Mix the modified zinc oxide suspension and the colorant, then add it to the transparent adhesive solution, stir and adjust the color to obtain the adhesive solution;

[0124] (5) Preparation of soft capsule material: Take an appropriate amount of adhesive liquid and inject it into the adhesive spreader. After spreading the adhesive, dry it until the mass ratio of water in the soft capsule material is 5wt%~20wt%.

[0125] Method Eight:

[0126] (1) Preparation of titanium dioxide suspension: Titanium dioxide is mixed with an equal mass of plasticizer, stirred evenly, filtered, and titanium dioxide suspension is obtained for later use;

[0127] (2) Preparation of transparent adhesive solution: Mix the remaining plasticizer, purified water and gelling agent, heat to 70-80℃ until the gelling agent is completely dissolved to obtain transparent adhesive solution for later use;

[0128] (3) Preparation of adhesive solution: Mix titanium dioxide suspension and colorant, then add to transparent adhesive solution, stir and adjust color to obtain adhesive solution;

[0129] (4) Preparation of soft capsule material: Take an appropriate amount of adhesive liquid and inject it into the adhesive spreader. After spreading the adhesive, dry it until the mass ratio of water in the soft capsule material is 5wt%~20wt%.

[0130] Method Nine:

[0131] (1) Preparation of modified zinc oxide: Zinc oxide and modified starch were put into a mixer, the mixing speed was set to 10 rpm, and the mixture was mixed for 20 min. After the mixing was completed, the mixture was discharged and set aside for later use.

[0132] (2) Preparation of modified zinc oxide suspension: Mix modified zinc oxide with an equal mass of plasticizer, stir evenly, filter, and obtain modified zinc oxide suspension for later use;

[0133] (3) Preparation of flavoring agent solution: Dissolve the flavoring agent in an appropriate amount of purified water, filter, and obtain the flavoring agent solution for later use;

[0134] (4) Preparation of transparent adhesive solution: Mix the remaining plasticizer, purified water, flavoring agent solution and gelling agent, heat to 70-80℃ until the gelling agent is completely dissolved to obtain transparent adhesive solution for later use;

[0135] (5) Preparation of adhesive solution: Add modified zinc oxide suspension to transparent adhesive solution, stir and adjust color to obtain adhesive solution;

[0136] (6) Preparation of soft capsule material: Take an appropriate amount of adhesive liquid and inject it into the adhesive spreader. After spreading the adhesive, dry it until the mass ratio of water in the soft capsule material is 5wt%~20wt%.

[0137] Evaluation methods for soft capsule materials

[0138] Light-blocking properties of the rubber: The refractive index of the prepared soft capsule material is measured using an ellipsometer. The higher the refractive index value, the stronger the light-blocking ability.

[0139] Rubber whiteness: The obtained soft capsule material is measured using a colorimeter to determine the "L" value. The "L" value represents the brightness of the object, with 0-100 representing black to white.

[0140] Rubber stability: After the prepared soft capsule material is exposed to light for 1 month, the "ΔE*" value is measured using a colorimeter. "ΔE*" is the total color difference, and the higher the value, the greater the color difference.

[0141] Based on the test results of the above test items, the scoring method in Table 1 was used for evaluation to obtain the final scores of the soft capsule materials of each embodiment and each comparative example.

[0142] Table 1

[0143]

[0144] Examples 1-6, Comparative Examples 1-4

[0145] Referring to Method 1 and Table 2, soft capsule materials of Examples 1 to 6 and Comparative Examples 3 to 4 were obtained.

[0146] Referring to Method 2 and Table 2, the soft capsule material of Comparative Example 1 was obtained.

[0147] Referring to Method 3 and Table 2, the soft capsule material of Comparative Example 2 was obtained.

[0148] Table 2

[0149]

[0150] Note: " / " indicates no addition; modified zinc oxide consists of 120-mesh zinc oxide and acid-treated starch in a weight ratio of 3:1; titanium dioxide has a mesh size of 120 mesh.

[0151] As shown in Table 2, in Examples 1-6, with the addition of modified zinc oxide in appropriate proportions, the light-blocking properties, whiteness, and stability of the soft capsule material were significantly improved, resulting in higher overall scores and a significant improvement in the overall situation. Control Example 1 shows the overall situation of the soft capsule material without other components added to the transparent adhesive, exhibiting no light-blocking properties, no whiteness, and high stability. Control Example 2 shows the overall situation of the soft capsule material with added titanium dioxide to the transparent adhesive. Although the light-blocking properties and whiteness were good, the stability was the worst. Compared to Control Example 1, this demonstrates that adding titanium dioxide affects the stability of the soft capsule material. In Control Examples 3-4, the proportion of modified zinc oxide was inappropriate, resulting in lower light-blocking and whiteness scores in Control Example 3, and failure to form Control Example 4, with low overall scores in both cases.

[0152] Compare with Examples 5 and 6

[0153] Referring to Method 4 and Table 3, soft capsule materials of Comparative Examples 5 to 6 were obtained.

[0154] Table 3

[0155]

[0156] As shown in Table 3, in Example 4, when zinc oxide (120 mesh) and modified starch (acid-treated starch) were mixed in an appropriate ratio, the opacity, whiteness, and stability of the soft capsule material were significantly improved, resulting in a higher overall score and a significant improvement in the overall condition. In Control Example 5, only modified starch was added; although the stability of the soft capsule material was good, the opacity and whiteness were poor, resulting in a lower overall score. In Control Example 6, only zinc oxide was added; although it improved the opacity, the whiteness and stability scores of the soft capsule material were low, resulting in a lower overall score.

[0157] Examples 7-10, Comparative Examples 7-8

[0158] Referring to Method 1 and Table 4, soft capsule materials of Examples 7 to 10 and Comparative Examples 7 to 8 were obtained.

[0159] Table 4

[0160]

[0161] As shown in Table 4, when modified zinc oxide is added to the soft capsule material in an appropriate ratio, in Examples 4 and 7-10, the stability of the soft capsule material is improved, and the whiteness and opacity scores are also higher, resulting in a higher overall score and a significant improvement in the overall situation, as the zinc oxide (120 mesh) and modified starch (acid-treated starch) in the modified zinc oxide are mixed in an appropriate ratio.

[0162] Compare with Examples 9 to 12

[0163] Referring to Method 5 and Table 5, the soft capsule material of Comparative Example 9 was obtained.

[0164] Referring to Method 6 and Table 5, soft capsule materials of Comparative Examples 10 to 12 were obtained.

[0165] Table 5

[0166]

[0167] As shown in Table 5, in Comparative Examples 9-10, when titanium dioxide was added to the transparent adhesive, regardless of whether zinc oxide or modified starch was added, the stability scores of the soft capsule material were not high, far lower than those of Example 4, but higher than those of Comparative Example 2. In Comparative Examples 11-12, when modified starch was combined with calcium carbonate or magnesium oxide in the transparent adhesive, the light-blocking, whiteness, and stability scores of the soft capsule material were not high, far lower than those of Example 4, resulting in a low overall score.

[0168] Examples 11-14, Comparative Examples 13-14

[0169] Referring to Method 1 and Table 6, soft capsule materials of Examples 11 to 14 and Comparative Examples 13 to 14 were obtained.

[0170] Table 6

[0171]

[0172] As shown in Table 6, in Examples 2 and 11-14, the mesh size of the modified zinc oxide was within a suitable range. Higher mesh sizes resulted in higher light-blocking properties of the soft capsule material and a higher overall score. In Control Examples 13-14, the mesh size of the zinc oxide was unsuitable. Specifically, too low a mesh size resulted in large particle size, affecting the healing process during shot blasting of the soft capsule material; while too high a mesh size resulted in fine particle size, increasing the specific surface area of ​​the powder. Adding this to the adhesive increased the viscosity of the adhesive, affecting molding, and resulting in an overall score of 0.

[0173] Examples 15-16, Comparative Examples 15-16

[0174] Referring to Method 7 and Table 7, the soft capsule materials of Examples 15 and 16 were obtained.

[0175] Referring to Method 8 and Table 7, soft capsule materials of Comparative Examples 15 to 16 were obtained.

[0176] Table 7

[0177]

[0178] Note: " / " indicates no addition; modified zinc oxide is composed of 120-mesh zinc oxide and acid-treated starch in a weight ratio of 3:1; titanium dioxide has a mesh size of 120 mesh; caramel coloring is added, and the soft capsule material is brown; lemon yellow, bright blue, and allura red colorings are added, and the soft capsule material is the corresponding color, so the evaluation index of the whiteness of the rubber is deleted.

[0179] As shown in Table 7, when colorants are added to the transparent adhesive to make colored soft capsules, the colored soft capsules in Examples 15-16, which added titanium dioxide, faded significantly after being exposed to light, indicating a low stability score and poor overall performance. In contrast, Examples 15-16, which added an appropriate proportion of modified zinc oxide, showed a significant improvement in the stability of the soft capsules, resulting in a higher overall score and a marked improvement in the overall situation.

[0180] Example 17, Comparative Examples 17-18

[0181] Referring to Method 1 and Table 8, the soft capsule material of Example 17 was obtained.

[0182] Referring to Method 2 and Table 8, the soft capsule material of Comparative Example 17 was obtained.

[0183] Referring to Method 3 and Table 8, the soft capsule material of Comparative Example 18 was obtained.

[0184] Table 8

[0185]

[0186] Note: " / " indicates no addition; modified zinc oxide consists of 120-mesh zinc oxide and acid-treated starch in a weight ratio of 3:1; titanium dioxide has a mesh size of 120 mesh.

[0187] Table 8 shows that when gelatin is combined with other colloids in the transparent adhesive solution, such as carrageenan and gellan gum, Comparative Example 17, which represents the overall condition of the soft capsule material without other components in the transparent adhesive solution, shows that the soft capsule material has no light-blocking properties and no whiteness, but high stability. Comparative Example 18, which added titanium dioxide, showed better light-blocking properties and whiteness in the soft capsule material, but the worst stability. Compared with Comparative Example 17, this demonstrates that adding titanium dioxide affects the stability of the soft capsule material. Example 17 added an appropriate proportion of modified zinc oxide, which significantly improved the light-blocking properties, whiteness, and stability of the soft capsule material, resulting in a higher overall score and a significant improvement in the overall condition. Compared with Example 3, this shows that adding other colloids does not affect the stability of the soft capsule material.

[0188] Examples 18-19, Comparative Examples 19-20

[0189] Referring to Method 1 and Table 9, the soft capsule materials of Examples 18 to 19 were obtained.

[0190] Referring to Method 3 and Table 9, soft capsule materials of Comparative Examples 19 to 20 were obtained.

[0191] Table 9

[0192]

[0193] As shown in Table 9, in Examples 18-19, when the modified starch in the modified zinc oxide was replaced with acetate starch or hydroxypropyl starch, the light-blocking properties, whiteness, and stability of the soft capsule material were significantly improved compared to Control Examples 1-2, resulting in a higher overall score. In Control Examples 19-20, when the transparent adhesive was combined with titanium dioxide and acetate starch or hydroxypropyl starch, the stability of the soft capsule material was not significantly improved, and was far lower than that of Examples 18-19, resulting in a lower overall score.

[0194] Examples 20-22

[0195] Referring to Method 1 and Table 10, the soft capsule materials of Examples 20 to 21 were obtained.

[0196] Referring to Method Nine and Table 10, the soft capsule material of Example 22 was obtained.

[0197] Table 10

[0198]

[0199] Note: " / " indicates no addition; the modified zinc oxide consists of 120-mesh zinc oxide and acid-treated starch in a weight ratio of 3:1.

[0200] Table 10 shows that in Examples 20-21, when other components, such as sorbitol or polyethylene glycol, were added to the plasticizer in the transparent adhesive, the addition of an appropriate proportion of modified zinc oxide significantly improved the light-blocking properties, whiteness, or stability of the soft capsule material, resulting in a higher overall score, with effects comparable to Example 4. In Example 22, when flavoring agents, such as steviol glycosides, were added to the transparent adhesive, the addition of an appropriate proportion of modified zinc oxide significantly improved the light-blocking properties, whiteness, or stability of the soft capsule material, resulting in a higher overall score, with effects comparable to Example 4. This indicates that adding other substances, such as flavoring agents, has almost no impact on the light-blocking properties, whiteness, or stability of the soft capsule material.

[0201] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0202] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims.

Claims

1. A soft capsule material, characterized in that, The components include the following parts by weight: 3-25 parts modified zinc oxide, 30-100 parts plasticizer and 40-150 parts gelling agent; The modified zinc oxide comprises zinc oxide and a modifier, wherein the weight ratio of zinc oxide to modifier is (1~19):1, the mesh size of zinc oxide is 120 mesh to 3000 mesh, the modifier is modified starch, the modified starch is selected from one or more of acid-treated starch, acetate starch and hydroxypropyl starch, the gelling agent is selected from one or more of starch, gelatin, carrageenan and gellan gum, and the plasticizer is selected from one or more of glycerol, sorbitol and polyethylene glycol.

2. The soft capsule material according to claim 1, characterized in that, The soft capsule material comprises the following components in parts by weight: 10-25 parts modified zinc oxide, 40-60 parts plasticizer and 90-110 parts gelling agent.

3. The soft capsule material according to claim 2, characterized in that, The weight ratio of zinc oxide to modifier is (1~15):

1.

4. The soft capsule material according to any one of claims 1 to 3, characterized in that, It also includes colorants.

5. The soft capsule material according to claim 4, characterized in that, The weight ratio of the modified zinc oxide to the colorant is (3~25):(0.01~10).

6. The soft capsule material according to claim 4, characterized in that, The colorant is selected from one or more of caramel coloring, lemon yellow coloring, allure red coloring, and brilliant blue coloring.

7. The soft capsule material according to any one of claims 1 to 3, characterized in that, It also includes flavoring agents.

8. The soft capsule material according to claim 7, characterized in that, The weight ratio of the modified zinc oxide to the flavoring agent is (3~25):(0.01~10).

9. The soft capsule material according to claim 7, characterized in that, The flavoring agent is selected from one or more of sugar alcohols, glycosides, flavorings, fruit juices, and fruit powders.

10. The soft capsule material according to any one of claims 1 to 3, 5 to 6, and 8 to 9, characterized in that, It also includes water, which accounts for 5 wt% to 20 wt% of the mass of the soft capsule material.

11. A method for preparing a soft capsule material according to any one of claims 1 to 10, characterized in that, Includes the following steps: The modified zinc oxide is prepared by mixing the zinc oxide and the modifier; A modified zinc oxide suspension is prepared by mixing a portion of the plasticizer with the modified zinc oxide. A transparent adhesive solution is prepared using the remaining plasticizer and gelling agent; The modified zinc oxide suspension and the transparent adhesive were mixed to prepare the adhesive solution; The soft capsule material is prepared using the adhesive solution.

12. A soft capsule, characterized in that, It includes contents and a soft capsule covering the contents, the soft capsule being as described in any one of claims 1 to 10.

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