A soft capsule outer coating powder composition, a soft capsule outer coating layer and a preparation method thereof

Abstract

The present invention relates to the technical field of food processing, and particularly relates to a soft capsule outer coating powder composition, a soft capsule outer coating layer and a preparation method thereof. The soft capsule outer coating powder composition of the present invention comprises the following components in parts by weight: 60 - 100 parts of starch, 0 - 20 parts of calcium carbonate, 0.5 - 5 parts of magnesium hydrosilicate, 0.1 - 1 part of zein, and 0.2 - 4 parts of colloidal silicon dioxide. This soft capsule outer coating powder composition can not only ensure a uniform outer coating layer, no powder shedding, and a good taste of the soft capsule product, but also ensure that the soft capsule does not adhere, deform, leak pills, etc. under high-temperature and high-humidity storage conditions; at the same time, it overcomes the adhesion problem caused by high contents of plasticizers or humectants and high water content in the capsule skin of chewable soft capsules, greatly increasing the market competitiveness of the product.

Description

Technical Field

[0001] The present invention relates to the technical field of food processing, and particularly relates to a soft capsule outer coating powder composition, a soft capsule outer coating layer and a preparation method thereof. Background Art

[0002] Soft capsules have the advantages of high bioavailability, strong sealing property, covering up the peculiar smell of raw materials, etc., and have great competitive advantages in the food and health food consumer markets. In recent years, in addition to nutritional components, consumers have also paid more and more attention to the taste, smell and convenience of taking products. In the traditional process, in order to increase the chewing taste, it is necessary to increase the dosage of plasticizer and water in the capsule shell of the soft capsule, but problems such as adhesion and oil leakage are likely to occur during the later storage of the product; currently known methods for solving the adhesion of soft capsules mainly include: (1) using gelatin in combination with modified starch, carrageenan, xanthan gum-gellan gum or pullulan polysaccharide, but in the actual production process, it is still necessary to control the moisture content of the capsule shell below 10%, and at the same time, when the storage conditions are higher than 40°C or the relative humidity is greater than 60%, the soft capsules are still likely to adhere into blocks; (2) adding microcrystalline cellulose, lecithin, vegetable oil, etc. to the capsule shell formula. However, this method does not effectively change the taste of the soft capsule, and at the same time, its use has limitations and can only be applied to gelatin-based soft capsules, and even problems such as too long disintegration time or cracking at the seams may occur during storage; (3) performing film coating on the outer layer of the soft capsule or applying anti-adhesion substances such as polydimethylsiloxane. Anti-adhesion substances commonly used in production are acrylic resin, hydroxypropyl methylcellulose, polydimethylsiloxane, etc., but their dosages are limited in food and cannot be applied to food and health foods. The above three methods do not effectively improve the taste of the soft capsule, and the anti-adhesion effect of the soft capsule also needs to be improved.

[0003] In addition, Patent Application CN104606678A discloses a soft soft capsule and a preparation method thereof. By utilizing the property of erythritol having low-temperature crystallization and adding it to the capsule shell of the soft capsule, the taste can be improved to a certain extent, but when the dosage of the humectant is increased in the capsule shell formula or under high-temperature and high-humidity storage conditions, problems such as adhesion and deformation of the product will still occur. Summary of the Invention

[0004] The present invention provides a soft capsule outer coating powder composition, a soft capsule outer coating layer and a preparation method thereof.

[0005] To solve the problems of easy adhesion, deformation, and leakage of soft capsules in the prior art (especially under storage conditions of high humectants, plasticizers, moisture content, or high temperature and high humidity), the present invention has developed a soft capsule outer coating powder composition. The present invention discovers that starch and zein can play a synergistic cooperation role with magnesium silicate hydrate and silica micropowder or with magnesium silicate hydrate, silica micropowder, and calcium carbonate in preventing the adhesion and deformation of soft capsules. Their combined effect is significantly better than the individual effect, and it is applicable to soft capsules prepared from various common raw materials. In addition, starch and zein can better solve the problem of poor taste when using magnesium silicate hydrate, silica micropowder, and calcium carbonate, which is beneficial to improving the overall taste of soft capsule products containing an outer coating layer; while magnesium silicate hydrate, silica micropowder, and calcium carbonate can better solve the problems of poor uniformity and powder shedding of the outer coating layer formed by starch and zein, and improve the uniformity of the outer coating layer and the product appearance.

[0006] Specifically, the present invention provides the following technical solutions:

[0007] The present invention provides a soft capsule outer coating powder composition, and the soft capsule outer coating powder composition contains the following components in parts by weight: 60 - 100 parts of starch, 0 - 20 parts of calcium carbonate, 0.5 - 5 parts of magnesium silicate hydrate, 0.1 - 1 part of zein, and 0.2 - 4 parts of silica micropowder.

[0008] In the above composition, the starch is one or more selected from tapioca starch, corn starch, and potato starch.

[0009] Preferably, the starch is tapioca starch. The present invention discovers that compared with starch sugars, starch hydrolysates, and other types of starch, tapioca starch can cooperate well with zein, silica micropowder, and magnesium silicate hydrate, and promote the improvement of the effect of the composition in preventing the adhesion and deformation of soft capsules.

[0010] In the above-mentioned soft capsule outer coating powder composition, the ratio of the total mass of starch and zein to the total mass of calcium carbonate, magnesium silicate hydrate, and silica micropowder is (80 - 100):(0.7 - 20).

[0011] The present invention discovers that controlling the ratio of the total mass of starch and zein to the total mass of calcium carbonate, magnesium silicate hydrate, and silica micropowder within the above range is more conducive to promoting the cooperation between components and significantly improving the effect of the composition in preventing the adhesion and deformation of soft capsules.

[0012] Preferably, the soft capsule outer coating powder composition contains the following components in parts by weight: 80 - 100 parts of starch, 0 - 20 parts of calcium carbonate, 0.5 - 2 parts of magnesium silicate hydrate, 0.1 - 0.5 part of zein, and 0.2 - 2 parts of silica micropowder.

[0013] The soft capsule outer coating composition described above results in a uniform outer coating of the soft capsule, with no excess powder at the seams. Moreover, even under different conditions such as increasing the amount of plasticizer or humectant in the capsule shell, the water content of the capsule shell reaching 12%-20%, high temperatures of 40°C and above, and storage conditions with a relative humidity of over 60%, it can still ensure that the soft capsules do not stick together, have good free-flowability, and show no deformation or leakage of pills.

[0014] When the above-mentioned soft capsule outer coating composition is applied to chewable soft capsules, it can achieve a better chewing texture when the content of plasticizer or humectant in the capsule shell is increased and the water content of the dried capsule shell reaches 8%-20%. This is beneficial for enhancing the market competitiveness of the product, and at the same time, it will not stick together during storage under high-temperature and high-humidity conditions.

[0015] In some embodiments of the present invention, the soft capsule outer coating composition comprises the following components in parts by weight: 80-100 parts of starch, 10-20 parts of calcium carbonate, 0.5-2 parts of magnesium silicate hydrate, 0.1-0.5 parts of zein, and 0.2-2 parts of colloidal silica.

[0016] In other embodiments of the present invention, the soft capsule outer coating composition comprises the following components in parts by weight: 80-100 parts of starch, 0.5-2 parts of magnesium silicate hydrate, 0.1-0.5 parts of zein, and 0.2-2 parts of colloidal silica.

[0017] To better ensure the appearance and taste of the soft capsule, the above-mentioned soft capsule outer coating composition further comprises a pigment and / or a flavoring agent.

[0018] Preferably, the flavoring agent is an essence and / or fruit powder.

[0019] Preferably, the mass percentage content of the pigment is 0.1%-2%, and / or the mass percentage content of the flavoring agent is 0.1%-8%.

[0020] The particle size of the above-mentioned soft capsule outer coating composition is 200 mesh - 500 mesh (i.e., 100% passes through a 200 mesh - 500 mesh sieve). The particle size affects the retention amount of the outer coating on the surface of the dried soft capsule. If the particles are too large, the outer coating on the surface of the soft capsule will be uneven and not easily retained for a long time.

[0021] The present invention provides the application of the above-mentioned soft capsule outer coating composition in the preparation of soft capsule products.

[0022] The soft capsule outer coating composition of the present invention is applicable to soft capsules prepared from various common raw materials. Therefore, in the above application, the soft capsule can be different types of soft capsules such as gelatin-based soft capsules, plant gum soft capsules, or gelatin-plant gum mixed gum soft capsules.

[0023] The present invention provides a soft capsule outer coating, which comprises the soft capsule outer coating powder composition described above, or is prepared from the soft capsule outer coating powder composition described above.

[0024] The present invention provides a method for preparing the soft capsule outer coating described above, the method comprising: wrapping the soft capsule outer coating powder composition on the outer surface of the soft capsule, and then performing shaping and drying.

[0025] Preferably, the dosage of the outer coating powder composition is 0.5%-5% (more preferably 1%-2%) of the total weight of the soft capsules. If the dosage of the outer coating powder is too little or too much, the outer coating of the soft capsule will be uneven. Moreover, if the dosage is too much, there will be more outer coating powder at the seam, resulting in poor sensory quality and affecting the taste.

[0026] The method for preparing the soft capsule outer coating described above comprises: putting the soft capsule into a powder coating bag containing the soft capsule outer coating powder composition, wrapping the soft capsule outer coating powder composition on the outer surface of the soft capsule, taking out the soft capsule for drying, and after drying, removing the excess soft capsule outer coating powder composition on the surface.

[0027] The method for preparing the soft capsule outer coating described above has the advantages of simple process, high production efficiency, low processing cost, etc.

[0028] The present invention provides a soft capsule product, which comprises a soft capsule body and an outer coating, and the outer coating comprises the soft capsule outer coating powder composition described above, or is prepared from the soft capsule outer coating powder composition described above.

[0029] The soft capsule body described above comprises a capsule shell and contents.

[0030] The present invention provides a method for preparing the soft capsule product described above, the method comprising: proportioning, dissolving the gel according to the raw material formula of the capsule shell of the soft capsule, after evacuating to reach the expected viscosity and moisture requirements, performing pill pressing with the contents of the soft capsule, obtaining the soft capsule after shaping, wrapping the soft capsule outer coating powder composition on the outer surface of the soft capsule to prepare the outer coating, taking out the soft capsule for drying, and after drying, removing the excess outer coating powder composition on the surface.

[0031] In some embodiments of the present invention, the method for preparing the soft capsule product comprises:

[0032] (1) Dissolving the gel: melting the raw materials of the capsule shell of the soft capsule (for example: gelatin or vegetable gum, plasticizer, humectant, pigment, purified water, etc.), waiting until there are no obvious particles in the gel solution, evacuating to the expected viscosity and moisture, filtering, and then keeping the gel solution warm for standby.

[0033] (2) Encapsulation: Feed the content of the soft capsule and the glue solution from step (1) into the encapsulation machine, adjust the equipment parameters and the amount of lubricating oil, set the thickness of the rubber skin and the filling amount of the content, and perform encapsulation.

[0034] (3) Shaping and oil wiping: Feed the encapsulated soft capsules into a rotating cage and wipe off the oil on the surface of the soft capsules.

[0035] (4) Coating the outer layer: Feed the soft capsules with the surface oil wiped off into the next rotating cage and place them in an outer powder bag containing the outer powder composition of the soft capsules to coat the outer layer.

[0036] (5) Drying and shaping: The soft capsules after coating the outer layer continue to be shaped and dried until the moisture content of the capsule skin reaches 8%-20%, and the dried soft capsules are rotated in the rotating cage for another 3-10 minutes.

[0037] The capsule skin raw materials of the above soft capsules may include gelatin, vegetable gum or gelatin-modified starch mixed gum, with or without the addition of sweeteners, flavors or natural fruit juice / powder. Among them, the plasticizer is mainly glycerol, etc., the humectant is mainly sorbitol, etc., and the sweetener can be one or several of xylitol, erythritol, steviol glycoside, mogroside, sucralose, etc.

[0038] In the above step (3), the time for shaping and oil wiping is controlled within 10-30 minutes; the residual oil amount on the surface of the soft capsules is controlled below 5 ppm; the moisture content of the capsule skin is above 25%. Excessive oil on the surface of the soft capsules will affect the retention of the outer layer, and too low moisture content on the surface of the soft capsules will cause the outer layer to not be coated on the surface of the soft capsules.

[0039] In the above step (4), the environmental conditions are controlled at a temperature of 18°C-25°C and a relative humidity of 35%-45%; the process time for coating the outer layer is controlled within 3-10 minutes. If the time is too short, the outer layer cannot effectively adhere to the surface of the soft capsules, and if the time is too long, it will cause unnecessary waste of materials.

[0040] In the above step (4), the ratio of the length of the outer powder bag to the length of the baffle in the rotating cage is 0.5-2:1, and the ratio of its width to the width of the baffle in the rotating cage is 3-4:2. If the outer powder bag is too short or too narrow, the outer layer of the soft capsules in the rotating cage will be uneven, and some soft capsules cannot be coated with the outer layer within the optimal process time, which requires extending the process time for coating the outer layer and increasing the processing cost; if the outer powder bag is too long or too wide, it will cause unnecessary waste of materials.

[0041] The beneficial effects of the present invention at least include: The soft capsule outer coating powder composition provided by the present invention can not only ensure the uniformity of the outer coating layer, no powder dropping, and good taste of the soft capsule product, but also ensure that when the soft capsule is stored under high-temperature and high-humidity conditions (for example, the temperature reaches above 40°C or the relative humidity reaches above 60%), problems such as sticking, deformation, and leakage of pills do not occur; at the same time, it overcomes the sticking problem caused by the high content of plasticizers or humectants in the capsule skin of chewable soft capsules and the relatively high water content in the capsule skin, and ensures a softer and more elastic taste when chewed, greatly increasing the market competitiveness of the product.

[0042] The preparation method of the soft capsule outer coating layer provided by the present invention has simple process, high production efficiency, and low processing cost, and has good application value and popularization significance. Detailed implementation manners

[0043] To make the objectives, technical solutions and advantages of the present invention clearer, the technical solutions in the present invention will be clearly and completely described below. Apparently, the described embodiments are some, but not all, of the embodiments of the present invention. All other embodiments obtained by those of ordinary skill in the art without making creative efforts based on the embodiments in the present invention belong to the scope of protection of the present invention.

[0044] Example 1

[0045] This example provides an outer coating powder composition, which contains the following components in parts by weight: 80 parts of tapioca starch, 16.3 parts of calcium carbonate, 0.5 part of hydrated magnesium silicate, 0.2 part of zein, and 2 parts of microcrystalline silica.

[0046] This example also provides a preparation method of the above outer coating powder composition, which is: mixing all components evenly and then passing through a 300-mesh sieve.

[0047] Example 2

[0048] This example provides an outer coating powder composition, which contains the following components in parts by weight: 80 parts of tapioca starch, 10 parts of calcium carbonate, 1.5 parts of hydrated magnesium silicate, 0.5 part of zein, 0.4 part of microcrystalline silica, 1 part of pigment, and 5.3 parts of essence / fruit powder.

[0049] This example also provides a preparation method of the above outer coating powder composition, which is: mixing all components evenly and then passing through a 300-mesh sieve.

[0050] Example 3

[0051] This example provides an outer coating powder composition, which contains the following components in parts by weight: 99.2 parts of tapioca starch, 0.5 part of hydrated magnesium silicate, 0.1 part of zein, and 0.2 part of microcrystalline silica.

[0052] This embodiment also provides a method for preparing the above-mentioned outer coating powder composition, which is: mixing all components evenly and then passing them through a 300-mesh sieve.

[0053] Example 4

[0054] This embodiment provides a gelatin soft capsule product, which comprises a content, a capsule shell, and the outer coating powder composition of Example 1 wrapped on the outer surface of the capsule shell.

[0055] This embodiment also provides a method for preparing the above-mentioned gelatin soft capsule product, which includes the following steps:

[0056] (1) Gelatin sol preparation: Weigh accurately according to the capsule shell formula of the soft capsule (the weight ratio of each component is: 100 parts of gelatin, 45 parts of glycerol, and 100 parts of water). Add each component to a gelatin melting tank for gelatin melting. Wait until there are no obvious particles in the gelatin solution, evacuate to a viscosity of 18,000 mPa·s, the water content of the gelatin solution is 39%, and transfer the gelatin solution to a heat preservation bucket after filtering through a 100-mesh filter cloth, and keep it at 55°C for standby.

[0057] (2) Pill pressing: Use pure vegetable oil as the content and send it into the pill press together with the gelatin solution in step (1). Adjust the equipment parameters and the amount of lubricating oil used, set the thickness of the capsule shell to 0.72 nm and the filling amount of the content, and perform pill pressing.

[0058] (3) Shaping and oil wiping: Send the soft capsules shaped in step (2) into a rotating cage, and put a clean towel to wipe off the oil on the surface of the soft capsules, and control the time at 15 min.

[0059] (4) Outer coating layer: Send the soft capsules wiped with oil into the next rotating cage, and put them into an outer coating powder bag filled with the outer coating powder composition of Example 1. The ratio of the length of the bag to the length of the rotating cage baffle is 1:1, and the ratio of the width is 1.5:1. Wrap the outer coating layer, and control the time at 5 min.

[0060] (5) Drying and shaping: Send the soft capsules wrapped with the outer coating layer into a new rotating cage to continue shaping and drying. Stop when the water content of the capsule shell reaches 9%-10%, and rotate the dried soft capsules in the rotating cage for another 3 min.

[0061] Example 5

[0062] This embodiment provides a gelatin soft capsule product, which comprises a content, a capsule shell, and the outer coating powder composition of Example 2 wrapped on the outer surface of the capsule shell.

[0063] This embodiment also provides a method for preparing the above-mentioned gelatin soft capsule product, which includes the following steps:

[0064] (1) Sol: Weigh accurately according to the capsule skin formula of the soft capsule (the weight ratio of each component is: 100 parts of gelatin, 45 parts of glycerol, 100 parts of water). Add each component into the gelatin melting tank for gelatin melting. After the gelatin solution has no obvious particles, evacuate to a viscosity of 18000 mpa·s, with the water content of the gelatin solution being 39%. After filtering through a 100-mesh filter cloth, transfer the gelatin solution to a heat preservation barrel and keep it at 55°C for standby.

[0065] (2) Pill pressing: Use pure vegetable oil as the content and send it together with the gelatin solution in step (1) into the pill press. Adjust the equipment parameters and the amount of lubricating oil, set the capsule skin thickness to 0.72 nm and the content filling amount, and carry out pill pressing.

[0066] (3) Shaping and oil wiping: Send the soft capsules shaped in step (2) into a rotating cage, and put clean towels to wipe off the oil on the surface of the soft capsules, with the time controlled within 15 min.

[0067] (4) Outer coating: Send the soft capsules wiped with oil into the next rotating cage, and put them into an outer coating powder bag filled with the outer coating powder composition of Example 2. The ratio of the bag length to the length of the rotating cage baffle is 1:1, and the ratio of the width is 1.5:1. Carry out outer coating, with the time controlled within 5 min.

[0068] (5) Drying and shaping: Send the soft capsules coated with the outer coating into a new rotating cage to continue shaping and drying. Stop when the water content of the capsule skin reaches 9% - 10%. Keep the dried soft capsules in the rotating cage and continue to rotate for 3 min.

[0069] Example 6

[0070] This example provides a chewable soft capsule product, which comprises a content, a capsule skin, and the outer coating powder composition of Example 1 wrapped on the outer surface of the capsule skin.

[0071] This example also provides a preparation method of the above chewable soft capsule product, which comprises the following steps:

[0072] (1) Sol: Weigh accurately according to the capsule skin formula of the soft capsule (the weight ratio of each component is: 100 parts of gelatin, 115 parts of glycerol, 110 parts of water, 45 parts of sorbitol solution, 25 parts of modified starch, 10 parts of natural fruit powder). Add each component into the gelatin melting tank for gelatin melting. After the gelatin solution has no obvious particles, evacuate to a viscosity of 26000 mpa·s, with the water content of the gelatin solution being 33%. After filtering through a 100-mesh filter cloth, transfer the gelatin solution to a heat preservation barrel and keep it at 55°C for standby.

[0073] (2) Pill pressing: Use a uniform oil suspension as the content and send it together with the gelatin solution in step (1) into the pill press. Adjust the equipment parameters and the amount of lubricating oil, set the capsule skin thickness to 0.75 nm and the content filling amount, and carry out pill pressing.

[0074] (3) Shaping and oil wiping: Feed the shaped soft capsules into a rotating cage, and place a clean towel to wipe off the oil on the surface of the soft capsules, with the time controlled within 10 min.

[0075] (4) Coating the outer layer: Feed the soft capsules wiped with oil into the next section of the rotating cage, and place them into an outer powder bag filled with the outer powder composition of Example 1. The ratio of the length of the bag to the length of the rotating cage baffle is 1:1, and the ratio of the width is 1.5:1. Coat the outer layer, with the time controlled within 3 min.

[0076] (5) Drying and shaping: Feed the soft capsules coated with the outer layer into a new rotating cage and continue shaping for 2 h, then place them on a pill drying tray to continue drying. Stop when the moisture content of the capsule skin reaches 14%-18%. Rotate the dried soft capsules in the rotating cage for another 5 min.

[0077] Example 7

[0078] This example provides a chewable soft capsule product, which comprises a content, a capsule skin, and an outer powder composition of Example 2 wrapped on the outer surface of the capsule skin.

[0079] This example also provides a preparation method for the above chewable soft capsule product, which comprises the following steps:

[0080] (1) Sol preparation: Weigh accurately according to the capsule skin formula of the soft capsule (the weight ratio of each component is: 100 parts of gelatin, 115 parts of glycerol, 110 parts of water, 45 parts of sorbitol solution, 25 parts of modified starch, and 10 parts of natural fruit powder). Add each component into a gelatin melting tank for gelatin melting. Wait until there are no obvious particles in the gelatin solution, evacuate to a viscosity of 26000 mPa·s, with the moisture content of the gelatin solution being 33%. After filtering through a 100-mesh filter cloth, transfer the gelatin solution to a heat preservation bucket and keep it at 55°C for standby.

[0081] (2) Pill pressing: Feed the uniform oil suspension as the content and the gelatin solution in step (1) into a pill press. Adjust the equipment parameters and the amount of lubricating oil, set the thickness of the capsule skin to 0.75 nm and the filling amount of the content, and perform pill pressing.

[0082] (3) Shaping and oil wiping: Feed the shaped soft capsules into a rotating cage, and place a clean towel to wipe off the oil on the surface of the soft capsules, with the time controlled within 10 min.

[0083] (4) Coating the outer layer: Feed the soft capsules wiped with oil into the next section of the rotating cage, and place them into an outer powder bag filled with the outer powder composition of Example 2. The ratio of the length of the bag to the length of the rotating cage baffle is 1:1, and the ratio of the width is 1.5:1. Coat the outer layer, with the time controlled within 3 min.

[0084] (5) Drying and shaping: The soft capsules wrapped with the outer layer are sent to a new rotating cage for 2 hours of shaping, and then placed on a pill drying tray for further drying. The drying stops when the moisture content of the capsule skin reaches 14%-18%. The dried soft capsules are rotated in the rotating cage for another 5 minutes.

[0085] Example 8

[0086] This example provides a plant soft capsule product, which includes a content, a capsule skin, and the outer coating powder composition of Example 2 wrapped on the outer surface of the capsule skin.

[0087] This example also provides a preparation method for the above plant soft capsules, which includes the following steps:

[0088] (1) Sol-gel preparation: Weigh accurately according to the capsule skin formula of the soft capsule (the weight ratio of each component is: 100 parts of vegetable gum, 40 parts of glycerol, and 120 parts of water). Add each component to a gel melting tank for gel melting. Wait until there are no obvious particles in the gel solution, evacuate to a viscosity of 32000 mPa·s, with a moisture content of 41% in the gel solution. After filtering through a 100-mesh filter cloth, transfer the gel solution to a heat preservation bucket and keep it at 55°C for standby.

[0089] (2) Pill pressing: Use pure vegetable oil as the content and send it together with the gel solution in step (1) into a pill press. Adjust the equipment parameters and the amount of lubricating oil used, set the capsule skin thickness to 0.75 nm and the content filling amount, and perform pill pressing.

[0090] (3) Shaping and oil wiping: Send the shaped soft capsules after pressing into a rotating cage, and put a clean towel to wipe off the oil on the surface of the soft capsules, with the time controlled within 10 minutes.

[0091] (4) Outer coating: Send the soft capsules after wiping off the oil into the next section of the rotating cage, and put them into an outer coating powder bag filled with the outer coating powder composition of Example 2. The ratio of the bag length to the length of the rotating cage baffle is 1:1, and the ratio of the width is 1.5:1. Perform outer coating, with the time controlled within 3 minutes.

[0092] (5) Drying and shaping: The soft capsules wrapped with the outer layer are sent to a new rotating cage for 2 hours of shaping, and then placed on a pill drying tray for further drying. The drying stops when the moisture content of the capsule skin reaches 14%-16%. The dried soft capsules are rotated in the rotating cage for another 5 minutes.

[0093] Example 9

[0094] This example provides a plant soft capsule product, which includes a content, a capsule skin, and the outer coating powder composition of Example 3 wrapped on the outer surface of the capsule skin.

[0095] This example also provides a preparation method for the above plant soft capsules, which includes the following steps:

[0096] (1) Sol: Weigh accurately according to the capsule skin formula of soft capsules (weight ratio of each component: 100 parts of vegetable gum, 40 parts of glycerin, 120 parts of water). Add each component to the gelatinizing tank for gelatinization. Wait until there are no obvious particles in the glue solution, evacuate to a viscosity of 32000 mPa·s, the moisture content of the glue solution is 41%, and after filtering through a 100-mesh filter cloth, transfer the glue solution to a heat preservation bucket and keep it at 55°C for standby.

[0097] (2) Pill pressing: Use pure vegetable oil as the content and send it into the pill press together with the glue solution in step (1). Adjust the equipment parameters and the amount of lubricating oil, set the capsule skin thickness to 0.75 nm and the content filling amount, and carry out pill pressing.

[0098] (3) Shaping and oil wiping: Send the shaped soft capsules into a rotating cage, and put a clean towel to wipe off the oil on the surface of the soft capsules, and control the time within 10 minutes.

[0099] (4) Outer coating: Send the soft capsules wiped with oil into the next rotating cage, and put them into an outer coating powder bag containing the outer coating powder composition of Example 3. The ratio of the bag length to the length of the rotating cage baffle is 1:1, and the ratio of the width is 1.5:1. Apply the outer coating, and control the time within 3 minutes.

[0100] (5) Drying and shaping: Send the soft capsules coated with the outer coating into a new rotating cage for continued shaping for 2 hours, and then place them on a pill drying tray for continued drying. Stop when the moisture content of the capsule skin reaches 14%-16%, and continue to rotate the dried soft capsules in the rotating cage for 5 minutes.

[0101] Comparative Example 1

[0102] This comparative example provides a gelatin soft capsule product, which includes a content and a capsule skin.

[0103] The preparation method of the above-mentioned gelatin soft capsule product includes the following steps:

[0104] (1) Sol: Weigh accurately according to the capsule skin formula of soft capsules (weight ratio of each component: 100 parts of gelatin, 45 parts of glycerin, 100 parts of water). Add each component to the gelatinizing tank for gelatinization. Wait until there are no obvious particles in the glue solution, evacuate to a viscosity of 18000 mPa·s, the moisture content of the glue solution is 39%, and after filtering through a 100-mesh filter cloth, transfer the glue solution to a heat preservation bucket and keep it at 55°C for standby.

[0105] (2) Pill pressing: Use pure vegetable oil as the content and send it into the pill press together with the glue solution in step (1). Adjust the equipment parameters and the amount of lubricating oil, set the rubber skin thickness to 0.72 nm and the content filling amount, and carry out pill pressing.

[0106] (3) Shaping: Send the shaped soft capsules into a rotating cage for shaping.

[0107] (4) Drying: The soft capsules that have been shaped are sent to a new rotating cage for continued drying, and the drying stops when the moisture content of the capsule skin reaches 9% - 10%.

[0108] Comparative Example 2

[0109] This comparative example provides an outer coating powder composition, which contains the following components in parts by weight: sucrose powder (ground) 80 parts, calcium carbonate 16.3 parts, hydrated magnesium silicate 0.5 part, zein 0.2 part, and microcrystalline silica 2 parts.

[0110] After mixing the above components evenly, all are passed through a 300 - mesh sieve, filled into bags, and reserved for use.

[0111] This comparative example also provides a chewable soft capsule product, which contains contents, a capsule skin, and an outer coating powder composition wrapped on the outer surface of the capsule skin. Among them, the outer coating powder composition is the outer coating powder composition in this comparative example.

[0112] The preparation method of the above - mentioned chewable soft capsule product includes the following steps:

[0113] (1) Sol - gel: Weigh accurately according to the capsule skin formula of the soft capsule (the weight ratio of each component is: gelatin 100 parts, glycerol 115 parts, water 110 parts, sorbitol solution 45 parts, modified starch 25 parts, natural fruit powder 10 parts). Add each component to a gelatinizing tank for gelatinizing. After the glue solution has no obvious particles, evacuate to a viscosity of 26000 mPa·s, with the moisture content of the glue solution being 33%. After filtering through a 100 - mesh filter cloth, transfer the glue solution to a heat - preservation barrel and keep it at 55°C for standby.

[0114] (2) Pelletizing: Use a uniform oil suspension as the content and send it together with the glue solution in step (1) into a pelletizing machine. Adjust the equipment parameters and the amount of lubricating oil used, set the capsule skin thickness to 0.75 nm and the content filling amount, and carry out pelletizing.

[0115] (3) Shaping and oil wiping: Send the shaped soft capsules after pressing into a rotating cage, and put a clean towel to wipe off the oil on the surface of the soft capsules. Control the time within 10 min.

[0116] (4) Coating the outer layer: Send the soft capsules after wiping off the oil into the next - stage rotating cage, and put them into an outer coating powder bag containing the outer coating powder composition of this comparative example. The ratio of the length of the bag to the length of the rotating cage baffle is 1:1, and the ratio of the width is 1.5:1, and carry out coating the outer layer. Control the time within 5 min.

[0117] (5) Drying and shaping: Send the soft capsules after coating the outer layer into a new rotating cage for continued shaping for 2 h, then place them on a drying tray for continued drying. Stop when the moisture content of the capsule skin reaches 14% - 18%, and rotate the dried soft capsules in the rotating cage for another 5 min.

[0118] Comparative Example 3

[0119] This comparative example provides an outer coating powder composition, which contains the following components in parts by weight: 80 parts of maltodextrin, 16.3 parts of calcium carbonate, 0.5 part of magnesium silicate hydrate, 0.2 part of zein, and 2 parts of colloidal silica.

[0120] After mixing the above components evenly, all are passed through a 300-mesh sieve, filled into bags, and reserved for use.

[0121] This comparative example also provides a gelatin soft capsule product, which contains a content, a capsule shell, and an outer coating powder composition wrapped on the outer surface of the capsule shell. Among them, the outer coating powder composition is the outer coating powder composition in this comparative example.

[0122] The preparation method of the above gelatin soft capsule product includes the following steps:

[0123] (1) Sol-gel preparation: Weigh accurately according to the capsule shell formula of the soft capsule (the weight ratio of each component is: 100 parts of gelatin, 45 parts of glycerol, and 100 parts of water). Add each component to a gelatinization tank for gelatinization. Wait until there are no obvious particles in the glue solution, evacuate to a viscosity of 18,000 mPa·s, the moisture content of the glue solution is 39%, and transfer the glue solution to a heat preservation barrel after filtering through a 100-mesh filter cloth, and keep it warm at 55°C for standby.

[0124] (2) Pill pressing: Use pure vegetable oil as the content and send it together with the glue solution in step (1) into a pill press. Adjust the equipment parameters and the amount of lubricating oil used, set the thickness of the rubber skin to 0.72 nm and the filling amount of the content, and carry out pill pressing.

[0125] (3) Shaping and oil wiping: Send the soft capsules shaped in step (2) into a rotating cage, and put a clean towel to wipe off the oil on the surface of the soft capsules. Control the time within 15 minutes.

[0126] (4) Outer coating layer: Send the soft capsules wiped with oil into the next rotating cage, and put them into an outer coating powder bag containing the outer coating powder composition of this comparative example. The ratio of the length of the bag to the length of the rotating cage baffle is 1:1, and the ratio of the width is 1.5:1. Wrap the outer coating layer, and control the time within 5 minutes.

[0127] (5) Drying and shaping: Send the soft capsules wrapped with the outer coating layer into a new rotating cage to continue shaping and drying. Stop when the moisture content of the rubber skin reaches 9% - 10%. Rotate the dried soft capsules in the rotating cage for another 3 minutes.

[0128] Comparative Example 4

[0129] This comparative example provides an outer coating powder composition, which contains the following components in parts by weight: 16.3 parts of calcium carbonate, 0.5 part of magnesium silicate hydrate, and 2 parts of colloidal silica.

[0130] After mixing the above components evenly, all are passed through a 300-mesh sieve, filled into bags, and reserved for use.

[0131] This comparative example also provides a gelatin soft capsule product, which comprises a content, a capsule shell, and an outer coating powder composition wrapped on the outer surface of the capsule shell. Among them, the outer coating powder composition is the outer coating powder composition in this comparative example.

[0132] The preparation method of the above-mentioned gelatin soft capsule product comprises the following steps:

[0133] (1) Gelatin sol preparation: Weigh accurately according to the capsule shell formula of the soft capsule (the weight ratio of each component is: 100 parts of gelatin, 45 parts of glycerol, and 100 parts of water). Add each component into a gelatin melting tank for gelatin melting. Wait until there are no obvious particles in the gelatin solution, evacuate to a viscosity of 18,000 mPa·s, the water content of the gelatin solution is 39%, and transfer the gelatin solution to a heat preservation barrel after filtering through a 100-mesh filter cloth, and keep it at 55 °C for standby.

[0134] (2) Pill pressing: Use pure vegetable oil as the content and send it together with the gelatin solution in step (1) into a pill press. Adjust the equipment parameters and the amount of lubricating oil used, set the thickness of the rubber skin to 0.72 nm and the filling amount of the content, and carry out pill pressing.

[0135] (3) Shaping and oil wiping: Send the soft capsules shaped in step (2) into a rotating cage, and put a clean towel to wipe off the oil on the surface of the soft capsules, and control the time within 15 minutes.

[0136] (4) Outer coating layer: Send the soft capsules wiped with oil into the next rotating cage, and put them into an outer coating powder bag filled with the outer coating powder composition of this comparative example. The ratio of the length of the bag to the length of the rotating cage baffle is 1:1, and the ratio of the width is 1.5:1, and wrap the outer coating layer, and control the time within 5 minutes.

[0137] (5) Drying and shaping: Send the soft capsules wrapped with the outer coating layer into a new rotating cage to continue shaping and drying. Stop when the water content of the rubber skin reaches 9%-10%, and rotate the dried soft capsules in the rotating cage for another 3 minutes.

[0138] Comparative Example 5

[0139] This comparative example provides an outer coating powder composition, which comprises the following components in parts by weight: 80 parts of tapioca starch and 0.2 part of zein.

[0140] Mix the above components evenly and sieve them all through a 300-mesh sieve, then pack them into bags for standby.

[0141] This comparative example also provides a gelatin soft capsule product, which comprises a content, a capsule shell, and an outer coating powder composition wrapped on the outer surface of the capsule shell. Among them, the outer coating powder composition is the outer coating powder composition in this comparative example.

[0142] The preparation method of the above-mentioned gelatin soft capsule product comprises the following steps:

[0143] (1) Sol: Weigh accurately according to the capsule skin formula of the soft capsule (weight ratio of each component: 100 parts of gelatin, 45 parts of glycerin, 100 parts of water). Add each component to the gelatin melting tank for gelatin melting. After the gelatin solution has no obvious particles, evacuate to a viscosity of 18000 mpa·s, with the moisture content of the gelatin solution being 39%. After filtering through a 100-mesh filter cloth, transfer the gelatin solution to a heat preservation bucket and keep it at 55°C for standby.

[0144] (2) Pill pressing: Use pure vegetable oil as the content and send it together with the gelatin solution in step (1) into the pill press. Adjust the equipment parameters and the amount of lubricating oil, set the rubber skin thickness to 0.72 nm and the content filling amount, and carry out pill pressing.

[0145] (3) Shaping and oil wiping: Send the soft capsules shaped in step (2) into a rotating cage, and put clean towels to wipe off the oil on the surface of the soft capsules. Control the time within 15 min.

[0146] (4) Outer coating: Send the soft capsules wiped with oil into the next rotating cage, and put them into an outer coating powder bag containing the outer coating powder composition of this comparative example. The ratio of the bag length to the length of the rotating cage baffle is 1:1, and the ratio of the width is 1.5:1. Carry out outer coating, and control the time within 5 min.

[0147] (5) Drying and shaping: Send the soft capsules coated with the outer coating into a new rotating cage to continue shaping and drying. Stop when the moisture content of the rubber skin reaches 9% - 10%. Keep the dried soft capsules rotating in the rotating cage for another 3 min.

[0148] Comparative Example 6

[0149] This comparative example provides a soft soft capsule product, and its preparation method includes the following steps:

[0150] (1) Prepare soft soft capsules according to the method of Example 1 in Patent Application CN104606678A. The weight ratio of each component in the capsule skin formula is 35 parts of gelatin (bloom strength 180), 35 parts of glycerin, 30 parts of erythritol (200 mesh), and 35 parts of water. Reserve 0.2% of the total weight of erythritol. Put the materials into the gelatin melting tank for gelatin melting. After there are no obvious particles, evacuate. When the viscosity of the gelatin solution reaches 28000 mpa·s, add the reserved erythritol and stir evenly slowly. After filtering through a 140-mesh filter cloth, transfer the gelatin solution to a heat preservation bucket and keep it at 55°C for standby.

[0151] (2) Pill pressing and shaping: Use the content of Example 2 and send it together with the gelatin solution in step (1) into the pill press. Adjust the equipment parameters and the amount of lubricating oil, set the rubber skin thickness to 0.75 nm and the content filling amount, and carry out pill pressing; send the shaped soft capsules into a rotating cage for shaping, with the ambient temperature being 20°C and the relative humidity being 30%.

[0152] (3) Drying and Crystallization: Place the shaped soft capsules non-overlapping on the perforated trays and send them into the drying room for drying. Control the ambient temperature at 25°C and the relative humidity at 40%. Dry until the moisture content of the rubber skin is 8%.

[0153] (4) Conditioning and Homogeneous Crystallization: Send the dried and crystallized soft capsules into a rotating cage for homogeneous crystallization, then place them non-overlapping in the perforated trays and put them in a high-humidity environment for conditioning until the moisture content of the soft capsules reaches 16%. The conditioning ambient temperature is 35°C and the relative humidity is 85%.

[0154] Detection of adhesion, deformation, and leakage of soft capsules in experimental examples

[0155] Pack the soft capsule products prepared in Examples 4-9 and each comparative example separately using bag packaging and bottle packaging, with 1000 capsules per bag and 60 capsules per bottle. Place each group of samples at 50°C and 65% humidity for 7 days, 15 days, and 30 days. After taking them out and placing them at room temperature, compare the situations of soft capsule adhesion, deformation, leakage, etc. The results are shown in Table 1.

[0156] Table 1

[0157]

[0158]

[0159]

[0160] The above results show that compared with the outer coating powder compositions of Comparative Examples 2-5, the outer coating powder compositions of Examples 1-3 are significantly superior in terms of the uniformity of preparing the outer coating layer and preventing the phenomena of adhesion, deformation, and leakage of soft capsules under high-temperature and high-humidity storage conditions. Using the outer coating powder composition of the present invention to prepare the outer coating layer of soft capsules can effectively ensure the prevention of adhesion, deformation, and leakage of soft capsules under high-temperature and high-humidity storage conditions while ensuring the uniformity of the outer coating layer, no powder shedding, and good taste of soft capsule products.

[0161] By comparing the chewing textures of the chewable soft capsules of Example 6 and the chewable soft capsules of Comparative Example 2, it can be seen that the final product moisture contents of the two are the same, the chewing textures are similar, both are relatively soft, and have a feeling of bursting beads; however, the chewable soft capsules of Example 6 have more advantages in preventing adhesion, deformation, and leakage.

[0162] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that they can still modify the technical solutions described in the foregoing embodiments or perform equivalent replacements for some of the technical features; and these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A soft capsule coated powder composition, characterized in that, The soft capsule coating powder composition consists of the following components in parts by weight: 60 - 100 parts of starch, 0 - 20 parts of calcium carbonate, 0.5 - 5 parts of magnesium silicate hydrate, 0.1 - 1 part of zein, and 0.2 - 4 parts of colloidal silicon dioxide.

2. The soft capsule outer coating powder composition according to claim 1, characterized in that, The starch is one or more selected from tapioca starch, corn starch, and potato starch.

3. The soft capsule outer coating powder composition according to claim 2, characterized in that, The starch is tapioca starch.

4. The soft capsule outer wrapping powder composition according to any one of claims 1 to 3, characterized in that, In the soft capsule coating powder composition, the ratio of the total mass of starch and zein to the total mass of calcium carbonate, magnesium silicate hydrate, and colloidal silicon dioxide is (80 - 100):(0.7 - 20).

5. The soft capsule outer coating powder composition according to any one of claims 1 to 3, characterized in that, The soft capsule coating powder composition consists of the following components in parts by weight: 80 - 100 parts of starch, 0 - 20 parts of calcium carbonate, 0.5 - 2 parts of magnesium silicate hydrate, 0.1 - 0.5 part of zein, and 0.2 - 2 parts of colloidal silicon dioxide.

6. The soft capsule outer coating powder composition according to any one of claims 1 to 3, characterized in that The particle size of the soft capsule coating powder composition is 200 mesh - 500 mesh.

7. A soft capsule outer coating powder composition, characterized in that, The soft capsule coating powder composition consists of the soft capsule coating powder composition according to any one of claims 1 - 6, and a pigment and / or a flavoring agent.

8. The soft capsule outer coating powder composition according to claim 7, characterized in that The flavoring agent is essence and / or fruit powder.

9. The soft capsule outer coating powder composition according to claim 7, wherein In the soft capsule coating powder composition, the mass percentage content of the pigment is 0.1% - 2%, and / or the mass percentage content of the flavoring agent is 0.1% - 8%.

10. The soft capsule outer coating powder composition according to any one of claims 7 to 9, characterized in that, The particle size of the soft capsule coating powder composition is 200 mesh - 500 mesh.

11. Use of the soft capsule coating powder composition according to any one of claims 1 - 6 or the soft capsule coating powder composition according to any one of claims 7 - 10 in the preparation of soft capsule products.

12. A soft capsule outer coating, characterized in that, The soft capsule coating layer contains the soft capsule coating powder composition according to any one of claims 1 - 6, or is prepared from the soft capsule coating powder composition according to any one of claims 1 - 6; Or, the soft capsule coating layer contains the soft capsule coating powder composition according to any one of claims 7 - 10, or is prepared from the soft capsule coating powder composition according to any one of claims 7 - 10.

13. The preparation method of the outer wrapping layer of the soft capsule according to claim 12, characterized in that, The method includes: wrapping the soft capsule coating powder composition on the outer surface of the soft capsule, and then performing shaping and drying.

14. The method according to claim 13, characterized in that, The dosage of the coating powder composition is 0.5% - 5% of the total weight of the soft capsules.

15. A soft capsule product, characterized in that, The soft capsule product includes a soft capsule body and a coating layer, and the coating layer contains the soft capsule coating powder composition according to any one of claims 1 - 6, or is prepared from the soft capsule coating powder composition according to any one of claims 1 - 6; Or, the coating layer contains the soft capsule coating powder composition according to any one of claims 7 - 10, or is prepared from the soft capsule coating powder composition according to any one of claims 7 - 10.

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