Soft capsule coating agent as well as preparation method and application thereof

Abstract

The invention discloses a soft capsule coating agent which comprises the following components in percentage by mass: 40-60% of pectin, 15-30% of a humectant, 10-20% of medium chain triglyceride, 10-20% of carnauba wax, 5-10% of hydroxypropyl methyl cellulose and 0.1-10% of glycerol, wherein the humectant is prepared from at least one of sorbitol, xylitol and isomaltitol. The invention also discloses a preparation method of the soft capsule coating agent and a soft capsule containing the soft capsule coating agent. According to the soft capsule coating agent disclosed by the invention, the problems of high-temperature and high-humidity deformation and caking of soft capsules and aging of capsule skins after long-time storage can be improved, and meanwhile, the soft capsule coating agent is good in barrier property and better in protection of soft capsule products.

Description

Technical Field

[0001] The present invention relates to the technical field of coating, and in particular to a soft capsule coating agent and a preparation method and application thereof. Background Art

[0002] Soft capsules refer to capsules that are directly coated with a certain amount of liquid drugs or nutrients, or that are dissolved or dispersed with suitable excipients to make solutions, suspensions, emulsions or semi-solids, and then sealed in spherical or elliptical soft capsule materials. They are widely used in the fields of medicine, food, cosmetics, etc. At present, the formula of soft capsule rubber is relatively mature, but there are also many problems that need to be solved: 1. Soft capsules will deform and stick together under high temperature and high humidity conditions, which will pose certain challenges to the transportation and shelf storage stability of soft capsule products. At the same time, due to the high-temperature deformation and bonding characteristics, cold chain transportation of soft capsule products is usually required in my country from May to October, which increases the transportation cost of the product; 2. Soft capsules with gelatin as the main capsule material will age during long-term storage, resulting in prolonged disintegration and dissolution time of the soft capsule, decreased dissolution rate or even complete insolubility, which poses a challenge to the quality of soft capsule products; 3. At present, the contents of soft capsules are mainly oil-based. Due to frequent opening of the cover and exposure to air during use by consumers, the peroxide value and acid value of the active ingredient of the product will not meet national standards or be unqualified due to improper storage by consumers.

[0003] Zhang Yinghua et al. conducted experimental research on soft capsule coating, and used acrylic resin, titanium dioxide, talcum powder, polyethylene glycol and ethanol to make a coating solution to coat the oxtail vegetable soft capsule to improve the problem of soft capsule rubber aging. Although this embodiment delays the problem of soft capsule rubber aging, the acrylic resin used is not a food raw material, and titanium dioxide and talcum powder have been banned by EU regulations. Patent CN106727416A proposes a film coating premix for soft capsules to solve the problems of soft capsules being difficult to store, easy to bond, and deformed, but its formula composition still uses more non-food and health food raw materials, and talcum powder is used as an anti-adhesive agent, and the overall formula is difficult to use in health food. Looking at the current research on soft capsule coating, there are few reports on the impact of coating on active ingredients, peroxide value and acid value in the product, and soft capsule coating formulas and technologies with cleaner, safer and more protective performance are in urgent need of research. Summary of the invention

[0004] The technical problem to be solved by the present invention is to provide a soft capsule coating agent, which can improve the problems of soft capsule deformation, agglomeration and long-term storage rubber aging, and has good barrier properties, thereby providing better protection for soft capsule products.

[0005] In order to solve the above technical problems, the present invention provides the following technical solutions:

[0006] The first aspect of the present invention provides a soft capsule coating agent, comprising the following ingredients by mass percentage: 40-60% pectin, 15-30% humectant, 10-20% medium chain triglyceride, 10-20% carnauba wax, 5-10% hydroxypropyl methylcellulose, and 0.1-10% glycerol;

[0007] Wherein, the moisturizing agent includes at least one of sorbitol, xylitol and isomalt.

[0008] In the soft capsule coating agent provided by the present invention, pectin and hydroxypropyl methylcellulose mainly play the role of film-forming agents, and the purpose is to form a protective film, which helps to protect the active ingredients inside the soft capsule from the influence of the external environment. The inventor found that compared with other film-forming agents, when pectin and hydroxypropyl methylcellulose are selected as the film-forming agents and the ratio between them is controlled to be (8-12): (1-2), the obtained coating agent has better film-forming ability, and can form a smooth and uniform film layer on the surface of the soft capsule by spraying, which is beneficial to improve the barrier property of the coating. When only pectin or hydroxypropyl methylcellulose is used as the film-forming agent, or the ratio of pectin and hydroxypropyl methylcellulose is not within the ratio range of (8-12): (1-2), the film-forming performance of the coating agent will be greatly reduced, which not only affects the appearance, smell and taste of the soft capsule, but also reduces the performance of the soft capsule in high temperature and high humidity environment, resulting in the soft capsule being easily bonded, deformed and leaking oil.

[0009] In the present invention, the ratio between pectin and hydroxypropyl methylcellulose can be 12:1, 10:1, 8:1, 6:1, 5:1, 4:1, etc., and is more preferably (5-10):1.

[0010] In the soft capsule coating agent provided by the present invention, the coating film can be modified by adding the ingredients of humectant, medium chain triglyceride, carnauba wax and glycerol to improve its performance. Among them, when the ratio of the ingredients of humectant, medium chain triglyceride, carnauba wax and glycerol is controlled to be (15-30): (10-20): (10-20): (0.1-10), the coating agent obtained has good fluidity and processability, further improves the film-forming ability of the coating agent, and helps to form a more uniform film layer; on the other hand, the ingredients of sorbitol, medium chain triglyceride, carnauba wax and glycerol can not only act on the film-forming agent alone to improve the performance of the film-forming agent, but also can further improve the performance of the film-forming agent through the synergistic effect between each other, so that the formed coating film layer has excellent high temperature and high humidity resistance, and is not easy to cause adhesion, aging and other problems when placed for a long time under high temperature and high humidity environment; at the same time, the formed coating film layer also has excellent barrier properties, can isolate moisture, and better protect the active material in the soft capsule. When any of the components is missing, or the ratio of sorbitol, medium-chain triglycerides, carnauba wax and glycerin is not within the range of (15-30):(10-20):(10-20):(0.1-10), the coating film layer's ability to resist high temperature and high humidity and its barrier properties are significantly reduced.

[0011] Sorbitol acts as a moisturizer in the formula, absorbing and retaining moisture, helping to maintain the softness and elasticity of the coating material, coordinating the plasticizing effect of glycerol on the rubber skin, improving the mechanical strength and durability of the soft capsule, and preventing the coating layer from becoming fragile due to excessive dryness; Brazilian palm wax and medium-chain triglycerides can form an oil layer on the film layer of pectin and hydroxypropyl methylcellulose, reducing the impact of moisture on the soft capsule, helping to extend the shelf life of the soft capsule, and reducing the adhesion between capsules, so that the soft capsule will not be damp and agglomerated during packaging and use. At the same time, medium-chain triglycerides in the formula can help improve the fluidity and processing performance of the coating material, making it easier to evenly apply the coating material on the soft capsule to ensure the uniformity of the coating layer.

[0012] Furthermore, in the soft capsule coating agent, the mass ratio of sorbitol, medium chain triglycerides, carnauba wax and glycerin is (20-30):(15-20):(15-20):(2-5).

[0013] Furthermore, the soft capsule coating agent includes the following ingredients by mass percentage: 40-55% pectin, 20-25% sorbitol, 10-20% medium chain triglycerides, 10-20% carnauba wax, 5-10% hydroxypropyl methylcellulose, and 0.1-5% glycerol.

[0014] Furthermore, the soft capsule coating agent also includes 0.01-1% of other components, and the other components include at least one of pigments and flavors.

[0015] The second aspect of the present invention provides a method for preparing the soft capsule coating agent, comprising the following steps:

[0016] S1. Add 4 to 11.5 times the mass of the coating agent raw material to the mixing drum and start stirring; then add the formulated amount of the coating agent raw material and keep stirring for 30 to 60 minutes to obtain a coating solution;

[0017] S2. Turn on the coating machine, add the soft capsule to the coating machine, turn on the hot air, keep the temperature of the soft capsule at 25 to 40 ° C; while turning the coating pan, control the speed of the coating pan at 3 to 5 rpm; then spray the coating liquid from the spray gun for coating;

[0018] S3. After all the coating liquid has been used up, the coated soft capsules are placed on a tray and placed in an environment with a temperature of 15-30°C and a humidity of 20-35%. When the moisture content of the rubber reaches 3-10%, the soft capsules are collected and the coating is completed.

[0019] Furthermore, in step S1 of the present invention, when adding the coating agent raw material, the coating agent raw material is preferably added uniformly to the center of the vortex to prevent the powder from floating on the liquid surface and promote the dissolution of the coating agent raw material. After all the coating agent raw materials are added, the stirring speed is reduced to make the vortex disappear, thereby reducing the generation of bubbles and preventing bubbles from entering the coating liquid.

[0020] In step S2 of the present invention, when coating, the temperature of the soft capsule is preferably controlled at 25-40°C, for example, 25°C, 28°C, 30°C, 32°C, 35°C, 38°C, 40°C, etc. If the temperature is too high, the soft capsule coating cannot be carried out, because the soft capsule will begin to soften and stick if the temperature is too high; if the temperature is too low, the coating agent cannot be attached to the surface of the soft capsule and dry in time, which will also cause sticking.

[0021] Furthermore, in step S2 of the present invention, the spray gun pressure is preferably 0.23-0.6 MPa, for example, it can be 0.23 MPa, 0.25 MPa, 0.3 MPa, 0.35 MPa, 0.4 MPa, 0.45 MPa, 0.5 MPa, 0.55 MPa, 0.6 MPa, etc.

[0022] The atomization pressure will affect the dispersed droplet size of the coating agent. If the atomization pressure is not well controlled, the surface of the soft capsule may be unevenly coated, making the capsule surface not smooth. In the present invention, the atomization pressure is preferably 0.4-0.8Mpa, for example, 0.4Mpa, 0.45Mpa, 0.5Mpa, 0.55Mpa, 0.6Mpa, 0.65Mpa, 0.7Mpa, 0.75Mpa, 0.8Mpa, etc.

[0023] Flattening pressure refers to the angle at which the coating liquid is sprayed out of the spray gun, which is equivalent to the contact angle between the atomized coating liquid and the soft capsule. By controlling the flattening pressure, the shape of the droplets sprayed from the spray gun can be adjusted. If the atomization pressure is not properly controlled, uneven spray coating may result. At the same time, since flat droplets dry faster than round droplets, the flattening pressure during the spraying process will also affect the coating speed. By controlling the appropriate flattening pressure, the coating speed can be accelerated. In the present invention, the flattening pressure is preferably 0.25 to 0.5 MPa, for example, it can be 0.25 MPa, 0.3 MPa, 0.35 MPa, 0.4 MPa, 0.45 MPa, 0.5 MPa, and the like.

[0024] The third aspect of the present invention provides a soft capsule, comprising a soft capsule shell and contents contained in the soft capsule shell, wherein the surface of the soft capsule shell has a coating formed by the soft capsule coating agent.

[0025] Furthermore, the mass of the coating accounts for 0.5-1.5wt% of the total mass of the soft capsule shell and the contents, for example, it can be 0.5%, 0.8%, 1.0%, 1.2%, 1.5%, etc.

[0026] Compared with the prior art, the present invention has the following beneficial effects:

[0027] 1. The soft capsule coating agent provided by the present invention can improve the deformation, agglomeration and rubber aging problems of the soft capsule under high temperature and high humidity conditions after coating the soft capsule product; at the same time, the coating film has good barrier properties, provides better protection for the soft capsule product, and significantly reduces the degradation rate of the active ingredient of the product, the peroxide value of the product and the acid value growth rate.

[0028] 2. The soft capsule coating agent provided by the present invention has all raw materials that can be used in health food and meet international requirements, and has high safety. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 are photos of the soft capsule samples of Comparative Example 1(a) and Example 1(b);

[0030] Figure 2This is a comparison diagram of the soft capsule samples of Comparative Example 1 (a) and Example 1 (b) after being placed in a constant temperature and humidity chamber (T: 37°C RH: 75%) for three months;

[0031] Figure 3 It is a comparison chart of the peroxide values ​​of the soft capsule samples of Comparative Example 1 and Example 1 in the cover opening test;

[0032] Figure 4 The figure is a comparison chart of the acid values ​​of the soft capsule samples of comparative example 1 and example 1 in the opening test. DETAILED DESCRIPTION

[0033] The technical solutions in the embodiments of the present invention will be described clearly and completely below in combination with the embodiments of the present invention and the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative work are within the scope of protection of the present invention.

[0034] Example 1

[0035] The soft capsule coating agent provided in this embodiment includes the following ingredients in percentage by mass: 45% pectin, 25% sorbitol, 10% medium chain triglycerides, 10% carnauba wax, 7.5% hydroxypropyl methylcellulose, and 2.5% glycerol.

[0036] The preparation method of the soft capsule coating agent of the present embodiment comprises the following steps:

[0037] S1. Add 5.25 times the amount of purified water of the coating powder into the mixing bucket and start stirring; add the formulated amount of coating agent evenly to the center of the vortex to prevent the powder from floating on the surface of the liquid; after all the coating agent is added, reduce the stirring speed to make the vortex disappear, and keep stirring for 45 minutes before use.

[0038] S2. After turning on the high-efficiency coating machine, add the soft capsule into the high-efficiency coating machine, turn on the hot air, and rotate the coating pot at the same time. Keep the material temperature at 25-40℃. The coating pot speed is controlled at 3 rpm for coating. The inlet air temperature of the coating machine is set to 50-60℃; the spray gun pressure in the drum is maintained at 0.5Mpa, the atomization pressure is 0.6Mpa, and the flattening pressure is 0.3Mpa. Among them, the amount of coating agent is 1.5% of the amount of soft capsule.

[0039] S3. After all the coating solution has been used up, the coated soft capsules are placed on a tray and kept at a temperature of 25°C and a humidity of 30%. When the moisture content of the rubber reaches 7%, the soft capsules are collected and the coating is completed.

[0040] Example 2

[0041] The soft capsule coating agent provided in this embodiment includes the following ingredients in percentage by mass: 40% pectin, 20% sorbitol, 12% medium chain triglycerides, 12% carnauba wax, 8% hydroxypropyl methylcellulose, and 8% glycerol.

[0042] The preparation method of the soft capsule coating agent of the present embodiment comprises the following steps:

[0043] S1. Add 4 times the amount of purified water as the coating powder into the mixing bucket and start stirring; evenly add the formulated amount of coating agent to the center of the vortex to prevent the powder from floating on the surface of the liquid; after all the coating agent is added, reduce the stirring speed to make the vortex disappear, and keep stirring for 45 minutes before use.

[0044] S2. After turning on the high-efficiency coating machine, add the soft capsule into the high-efficiency coating machine, turn on the hot air, and rotate the coating pot at the same time. Keep the material temperature at 25-40℃. The coating pot speed is controlled at 3 rpm for coating. The inlet air temperature of the coating machine is set to 50-60℃; the spray gun pressure in the drum is maintained at 0.5Mpa, the atomization pressure is 0.6Mpa, and the flattening pressure is 0.3Mpa. Among them, the amount of coating agent is 1.1% of the amount of soft capsule.

[0045] S3. After all the coating solution has been used up, the coated soft capsules are placed on a tray and kept at a temperature of 25°C and a humidity of 30%. When the moisture content of the rubber reaches 7%, the soft capsules are collected and the coating is completed.

[0046] Example 3

[0047] The soft capsule coating agent provided in this embodiment includes the following ingredients in percentage by mass: 40% pectin, 20% sorbitol, 15% medium chain triglycerides, 15% carnauba wax, 5% hydroxypropyl methylcellulose, and 5% glycerol.

[0048] The preparation method of the soft capsule coating agent of the present embodiment comprises the following steps:

[0049] S1. Add 6 times the amount of purified water as the coating powder into the mixing bucket and start stirring; evenly add the formulated coating agent to the center of the vortex to prevent the powder from floating on the surface of the liquid; after all the coating agent is added, reduce the stirring speed to make the vortex disappear, and keep stirring for 45 minutes before use.

[0050] S2. After turning on the high-efficiency coating machine, add the soft capsule into the high-efficiency coating machine, turn on the hot air, and rotate the coating pot at the same time. Keep the material temperature at 25-40℃. The coating pot speed is controlled at 3 rpm for coating. The inlet air temperature of the coating machine is set to 50-60℃; the spray gun pressure in the drum is maintained at 0.5Mpa, the atomization pressure is 0.6Mpa, and the flattening pressure is 0.3Mpa. Among them, the amount of coating agent is 0.8% of the amount of soft capsule.

[0051] S3. After all the coating solution has been used up, the coated soft capsules are placed on a tray and kept at a temperature of 25°C and a humidity of 30%. When the moisture content of the rubber reaches 7%, the soft capsules are collected and the coating is completed.

[0052] Example 4

[0053] The soft capsule coating agent provided in this embodiment includes the following ingredients in percentage by mass: 45% pectin, 25% xylitol, 10% medium chain triglycerides, 10% carnauba wax, 7.5% hydroxypropyl methylcellulose, and 2.5% glycerol.

[0054] The preparation method of the soft capsule coating agent of this embodiment is the same as that of Example 1.

[0055] Example 5

[0056] The soft capsule coating agent provided in this embodiment includes the following ingredients in percentage by mass: 45% pectin, 25% isomalt, 10% medium chain triglyceride, 10% carnauba wax, 7.5% hydroxypropyl methylcellulose, and 2.5% glycerol.

[0057] The preparation method of the soft capsule coating agent of this embodiment is the same as that of Example 1.

[0058] Comparative Example 1

[0059] The soft capsules provided in this comparative example are not coated.

[0060] Comparative Example 2

[0061] The soft capsule coating agent provided in this comparative example comprises the following ingredients in percentage by mass: 52.5% pectin, 25% sorbitol, 10% medium chain triglyceride, 10% carnauba wax and 2.5% glycerol.

[0062] The preparation method of the soft capsule coating agent of this comparative example is the same as that of Example 1.

[0063] Comparative Example 3

[0064] The comparative example provides a soft capsule coating agent, which comprises the following ingredients by mass percentage: 52.5% hydroxypropyl methylcellulose, 25% sorbitol, 10% medium chain triglyceride, 10% carnauba wax, and 2.5% glycerol.

[0065] The preparation method of the soft capsule coating agent of this comparative example is the same as that of Example 1.

[0066] Comparative Example 4

[0067] The soft capsule coating agent provided in this comparative example comprises the following ingredients in percentage by mass: 60% pectin, 20% medium-chain triglyceride, 10% carnauba wax, 7.5% hydroxypropyl methylcellulose and 2.5% glycerol.

[0068] The preparation method of the soft capsule coating agent of this comparative example is the same as that of Example 1.

[0069] Comparative Example 5

[0070] The comparative example provides a soft capsule coating agent, which comprises the following ingredients by mass percentage: 45% pectin, 25% sorbitol, 10% carnauba wax, 7.5% hydroxypropyl methylcellulose, and 12.5% ​​glycerol.

[0071] The preparation method of the soft capsule coating agent of this comparative example is the same as that of Example 1.

[0072] Comparative Example 6

[0073] The soft capsule coating agent provided in this comparative example comprises the following ingredients in percentage by mass: 45% pectin, 25% sorbitol, 10% medium chain triglyceride, 7.5% hydroxypropyl methylcellulose and 12.5% ​​glycerol.

[0074] The preparation method of the soft capsule coating agent of this comparative example is the same as that of Example 1.

[0075] Comparative Example 7

[0076] The comparative example provides a soft capsule coating agent, which comprises the following ingredients by mass percentage: 45% xanthan gum, 25% sorbitol, 10% medium chain triglyceride, 10% carnauba wax, 7.5% hydroxypropyl methylcellulose and 2.5% glycerol.

[0077] The preparation method of the soft capsule coating agent of this comparative example is the same as that of Example 1.

[0078] Comparative Example 8

[0079] The comparative example provides a soft capsule coating agent, which comprises the following ingredients by mass percentage: 45% pectin, 25% sorbitol, 10% medium chain triglyceride, 10% carnauba wax, 7.5% hydroxyethyl cellulose and 2.5% glycerol.

[0080] The preparation method of the soft capsule coating agent of this comparative example is the same as that of Example 1.

[0081] Comparative Example 9

[0082] The comparative example provides a soft capsule coating agent, which comprises the following ingredients by mass percentage: 40% pectin, 25% sorbitol, 10% medium chain triglyceride, 10% carnauba wax, 12.5% ​​hydroxypropyl methylcellulose and 2.5% glycerol.

[0083] The preparation method of the soft capsule coating agent of this comparative example is the same as that of Example 1.

[0084] Comparative Example 10

[0085] The comparative example provides a soft capsule coating agent, which comprises the following ingredients by mass percentage: 49% pectin, 25% sorbitol, 10% medium chain triglyceride, 10% carnauba wax, 3.5% hydroxypropyl methylcellulose, and 2.5% glycerol.

[0086] The preparation method of the soft capsule coating agent of this comparative example is the same as that of Example 1.

[0087] Comparative Example 11

[0088] The comparative example provides a soft capsule coating agent, which comprises the following ingredients by mass percentage: 45% pectin, 30% sorbitol, 7.5% medium chain triglyceride, 7.5% carnauba wax, 7.5% hydroxypropyl methylcellulose, and 2.5% glycerol.

[0089] The preparation method of the soft capsule coating agent of this comparative example is the same as that of Example 1.

[0090] Comparative Example 12

[0091] The comparative example provides a soft capsule coating agent, which comprises the following ingredients by mass percentage: 45% pectin, 12.5% ​​sorbitol, 10% medium chain triglyceride, 22.5% carnauba wax, 7.5% hydroxypropyl methylcellulose, and 2.5% glycerol.

[0092] The preparation method of the soft capsule coating agent of this comparative example is the same as that of Example 1.

[0093] Comparative Example 13

[0094] The comparative example provides a soft capsule coating agent, which comprises the following ingredients by mass percentage: 45% pectin, 15% sorbitol, 25% medium chain triglyceride, 5% carnauba wax, 7.5% hydroxypropyl methylcellulose, and 2.5% glycerol.

[0095] The preparation method of the soft capsule coating agent of this comparative example is the same as that of Example 1.

[0096] Comparative Example 14

[0097] The comparative example provides a soft capsule coating agent, which comprises the following ingredients by mass percentage: 45% pectin, 25% sorbitol, 7.5% medium chain triglyceride, 2.5% carnauba wax, 7.5% hydroxypropyl methylcellulose, and 12.5% ​​glycerol.

[0098] The preparation method of the soft capsule coating agent of this comparative example is the same as that of Example 1.

[0099] Comparative Example 15

[0100] The comparative example provides a soft capsule coating agent, which comprises the following ingredients by mass percentage: 45% pectin, 25% sorbitol, 10% short-chain triglyceride, 10% carnauba wax, 7.5% hydroxypropyl methylcellulose, and 2.5% glycerol.

[0101] The preparation method of the soft capsule coating agent of this comparative example is the same as that of Example 1.

[0102] Comparative Example 16

[0103] The comparative example provides a soft capsule coating agent, which comprises the following ingredients by mass percentage: 45% pectin, 25% sorbitol, 10% medium chain triglyceride, 10% beeswax, 7.5% hydroxypropyl methylcellulose, and 2.5% glycerol.

[0104] The preparation method of the soft capsule coating agent of this comparative example is the same as that of Example 1.

[0105] The formulations of the soft capsule coating agents of the embodiments and comparative examples are shown in Table 1.

[0106] Table 1

[0107]

[0108]

[0109] Performance Testing

[0110] 1. Sensory test

[0111] With reference to GB / T 10220-2012 “General Theory of Sensory Analysis Methodology”, 80 professional tasters were recruited to evaluate the appearance, smell, taste and overall preference of the soft capsules of Examples 1-5 and Comparative Example 1 according to a 9-point preference scale. The results are shown in Appendix 2.

[0112] Table 2

[0113] Appearance odor Taste Overall likeability Example 1 6.06 6.36 5.48 5.7 Example 2 5.92 6.17 5.64 5.65 Example 3 6.15 6.23 5.79 5.61 Example 4 6.09 6.19 5.57 5.59 Example 5 6.14 6.21 5.61 5.64 Comparative Example 1 5.69 6.3 5.54 5.62

[0114] From the comparison in Table 2, it can be seen that there is no significant difference in the sensory taste of the soft capsule samples before and after coating, and the sensory evaluation of the coated soft capsule is consistent with that of the uncoated sample.

[0115] 2. High temperature and high humidity environment test

[0116] The soft capsule samples of the embodiment and the comparative example were bottled with the same specifications and packaging materials, and then placed in a constant temperature and humidity chamber (T: 37°C, RH: 75%), and samples were taken every month to observe the status of the soft capsules in the bottles. Scoring was performed according to the scoring criteria in Table 3, and the results are shown in Appendix 4.

[0117] Table 3

[0118]

[0119] Table 4

[0120]

[0121]

[0122] See also Figure 1 Compared with the uncoated soft capsule samples, the appearance of the coated soft capsule samples is not much different.

[0123] See also Figure 2 After being placed in a high temperature and high humidity environment for three months, the uncoated soft capsule sample showed obvious surface collapse and deformation, and oil leakage occurred; while the soft capsule sample coated with the coating agent of Example 1 had a surface condition significantly better than that of the uncoated sample after being placed in a high temperature and high humidity environment for three months, and no obvious deformation or oil leakage occurred.

[0124] Please refer to Table 4. The coated soft capsule samples in Examples 1-3 were placed in a high temperature and high humidity environment for 1 to 3 months, and their scores were all maintained above 80. The appearance of the samples remained normal, with no obvious abnormalities such as adhesion and oil leakage.

[0125] In Comparative Example 1, the score of the uncoated soft capsule sample was greatly reduced after being placed in a high temperature and high humidity environment, and the accelerated score for 3 months was only 25. This shows that the uncoated soft capsule sample is not resistant to a high temperature and high humidity environment, and is prone to adhesion, deformation, oil leakage, etc.

[0126] Compared with Example 1, in Comparative Examples 2 to 6, when any one of the ingredients is missing in the coating agent formula, the score of the soft capsule sample for resistance to high temperature and high humidity environment will be greatly reduced. For example, in Comparative Example 2, the coating agent formula does not contain hydroxypropyl methylcellulose. From the results, the comprehensive score of the soft capsule sample accelerated for 1 month is 70, the comprehensive score accelerated for 2 months is 55, and the comprehensive score accelerated for 3 months is only 33. Although it is improved compared with the uncoated sample, it is still far equal to Example 1. Similarly, Comparative Examples 3-6 have similar results. This shows that the various components in the coating agent of the present invention are very critical and indispensable, and the lack of any component will have a great impact on the resistance to high temperature and high humidity of the soft capsule sample.

[0127] In the present invention, the selection of ingredients in the coating agent formula is very critical. If pectin, hydroxypropyl methylcellulose, and medium-chain triglycerides are replaced by other components, the performance of the coating agent will change, and the high temperature and high humidity resistance of the soft capsule sample will be significantly reduced. For example, in Comparative Example 15, short-chain triglycerides are used instead of medium-chain triglycerides. From the results, the comprehensive score of the soft capsule sample accelerated for 1 month is 73, the comprehensive score accelerated for 2 months is 57, and the comprehensive score accelerated for 3 months is 45, which is significantly reduced compared with Example 1. Similarly, Comparative Examples 7-8 and 16 also have similar results.

[0128] In addition, the ratio of pectin to hydroxypropyl methylcellulose in the coating agent is also very critical. Taking Comparative Examples 9-10 as examples, the ratios of pectin to hydroxypropyl methylcellulose in the coating agent are 3.2:1 and 14:1, respectively, which exceed the ratio of (8-12): (1-2). From the results, the comprehensive score of the soft capsule sample in Comparative Example 9 accelerated for 1 month is 75, the comprehensive score accelerated for 2 months is 63, and the comprehensive score accelerated for 3 months is 46, which is significantly lower than that in Example 1. Comparative Example 10 also has similar results.

[0129] Similarly, the ratio of sorbitol, medium chain triglyceride, carnauba wax and glycerol in the coating agent is also very critical. Taking Comparative Example 11 as an example, the ratio of sorbitol, medium chain triglyceride, carnauba wax and glycerol is pectin 30:7.5:7.5:2.5, which exceeds the range of (15-30):(10-20):(10-20):(0.1-10). From the results, the comprehensive score of the soft capsule sample accelerated for 1 month is 68, the comprehensive score accelerated for 2 months is 57, and the comprehensive score accelerated for 3 months is 45, which is significantly lower than that of Example 1.

[0130] Therefore, compared with the uncoated soft capsule samples in Comparative Example 1 and the coated soft capsule samples in Comparative Examples 2-16, the coated soft capsules using the formula of the present invention have a higher comprehensive score, indicating that they have better resistance to high temperature and high humidity, and are placed in a high temperature and high humidity environment for a long time without deformation or oil leakage.

[0131] 3. Disintegration time test

[0132] After the soft capsule samples of the embodiment and the comparative example were bottled according to the same specifications and the same packaging materials, they were placed in a constant temperature and humidity chamber (T: 37°C, RH: 75%), respectively. Referring to the disintegration time limit test method of Part IV 0921 of the Chinese Pharmacopoeia 2020 edition, samples were taken every month to measure the disintegration time limit of the soft capsules. The results are shown in Appendix 5.

[0133] Table 5

[0134]

[0135]

[0136] Please refer to Table 5. In Comparative Example 1, when the soft capsules were not coated with a coating agent, the disintegration time of the soft capsule sample accelerated for 1 month reached 18 minutes, the disintegration time accelerated for 2 months reached 29 minutes, and the disintegration time accelerated for 3 months reached 46 minutes.

[0137] In Examples 1-5, when the coating agent of the present invention is used to coat the soft capsule, the disintegration time of the soft capsule sample is significantly reduced. For example, in Example 1, the disintegration time of the soft capsule sample accelerated for 1 month is 12 minutes, the disintegration time accelerated for 2 months reaches 21 minutes, and the disintegration time accelerated for 3 months is only 27 minutes.

[0138] When any one of the ingredients is missing in the coating agent formula, the disintegration time of the soft capsule sample can be greatly extended. As in Comparative Example 2, the coating agent formula does not contain hydroxypropyl methylcellulose. From the results, the disintegration time of the soft capsule sample accelerated for 1 month reached 21min, the disintegration time accelerated for 2 months reached 33min, and the disintegration time accelerated for 3 months reached 51min, and the disintegration time compared with Example 1 increased significantly. This shows that the coating has aged under high temperature and high humidity, so the time of disintegration is extended. Similarly, there is a similar result in Comparative Examples 3-6. This shows that various components are very critical in the coating agent of the present invention, and none of them can be missing, and the lack of any component can have a great impact on the disintegration performance of the soft capsule sample.

[0139] In the present invention, the selection of ingredients in the coating agent formula is very critical. If pectin, hydroxypropyl methylcellulose, and medium-chain triglycerides are replaced by other components, the performance of the coating agent will be changed, and the disintegration of the soft capsule sample will be greatly extended. As in Comparative Example 15, short-chain triglycerides are used to replace medium-chain triglycerides. From the results, the disintegration time of the soft capsule sample accelerated by 1 month reached 18min, the disintegration time accelerated by 2 months reached 27min, and the disintegration time accelerated by 3 months reached 36min, and the disintegration time increased significantly compared with Example 1. Similarly, Comparative Examples 7-8 and 16 also have similar results.

[0140] In addition, the ratio of pectin to hydroxypropyl methylcellulose in the coating agent is also very critical. Taking Comparative Examples 9-10 as examples, the ratios of pectin to hydroxypropyl methylcellulose in the coating agent are 3.2:1 and 14:1, respectively, which exceed the ratio of (8-12): (1-2). From the results, the disintegration time of the soft capsule sample of Comparative Example 9 accelerated for 1 month reached 19 minutes, the disintegration time accelerated for 2 months reached 26 minutes, and the disintegration time accelerated for 3 months reached 34 minutes, which is a certain increase compared with Example 1. Comparative Example 10 also has similar results.

[0141] Similarly, the ratio of sorbitol, medium chain triglycerides, carnauba wax and glycerol in the coating agent is also very critical. Taking Comparative Example 11 as an example, the ratio of sorbitol, medium chain triglycerides, carnauba wax and glycerol is pectin 30:7.5:7.5:2.5, which exceeds the range of (15-30):(10-20):(10-20):(0.1-10). From the results, the disintegration time of the soft capsule sample accelerated for 1 month reached 18 minutes, the disintegration time accelerated for 2 months reached 24 minutes, and the disintegration time accelerated for 3 months reached 37 minutes, which is a certain increase compared with Example 1.

[0142] 4. Peroxide value and acid value test

[0143] The soft capsule samples of Example 1 and Comparative Examples 1-16 were bottled with the same specifications and packaging materials, and the lids were opened and closed every day to simulate consumers taking the soft capsules. The peroxide value and acid value of the soft capsules of the Example and Comparative Examples were measured every 7 days. The results are shown in Tables 6-7 respectively.

[0144] Table 6

[0145]

[0146]

[0147] Table 7

[0148]

[0149]

[0150] Please refer to Tables 6-7. In the daily exposure of consumers to open the lid, the peroxide value and acid value will gradually increase due to exposure to air. Compared with the uncoated soft capsules in Comparative Example 1, the growth rate of the soft capsule samples after coating is significantly lower than that of the uncoated soft capsule samples. Among them, the growth rates of the peroxide value and acid value of the soft capsule samples coated with the coating agents of Examples 1 to 5 are significantly lower than those of the coated soft capsules in other comparative examples. This shows that the coating film formed by the coating agent provided by the present invention has better barrier properties and better protection for the soft capsule product, thereby significantly reducing the degradation rate of the active ingredient of the product, the peroxide value of the product and the growth rate of the acid value.

[0151] The above-described embodiments are only preferred embodiments for fully illustrating the present invention, and the protection scope of the present invention is not limited thereto. Equivalent substitutions or changes made by those skilled in the art based on the present invention are within the protection scope of the present invention. The protection scope of the present invention shall be subject to the claims.

Claims

1. A soft capsule coating agent, characterized in that: The invention comprises the following ingredients by mass percentage: 40-60% pectin, 15-30% moisturizer, 10-20% medium chain triglyceride, 10-20% carnauba wax, 5-10% hydroxypropyl methylcellulose, and 0.1-10% glycerin; Wherein, the moisturizing agent includes at least one of sorbitol, xylitol and isomalt.

2. A soft capsule coating agent according to claim 1, characterized in that: The soft capsule coating agent comprises the following ingredients by mass percentage: 40-55% pectin, 20-25% moisturizer, 10-20% medium chain triglyceride, 10-20% carnauba wax, 5-10% hydroxypropyl methylcellulose and 0.1-5% glycerol.

3. A soft capsule coating agent according to claim 1, characterized in that: In the soft capsule coating agent, the ratio of pectin to hydroxypropyl methylcellulose is (5-10):

1.

4. A soft capsule coating agent according to claim 1, characterized in that: In the soft capsule coating agent, the mass ratio of the moisturizer, medium-chain triglyceride, carnauba wax and glycerin is (20-30):(15-20):(15-20):(2-5).

5. A soft capsule coating agent according to claim 1, characterized in that: The soft capsule coating agent also includes 0.01-1% of other components, and the other components include at least one of pigments and flavors.

6. The method for preparing a soft capsule coating agent according to any one of claims 1 to 5, characterized in that: The following steps are involved: S1. Add 4 to 11.5 times the mass of the coating agent raw material to the mixing drum and start stirring; then add the formulated amount of the coating agent raw material and keep stirring for 30 to 60 minutes to obtain a coating solution; S2. Turn on the coating machine, add the soft capsule to the coating machine, turn on the hot air, keep the temperature of the soft capsule at 25 to 40 ° C; while turning the coating pan, control the speed of the coating pan at 3 to 5 rpm; then spray the coating liquid from the spray gun for coating; S3. After all the coating liquid has been used up, the coated soft capsules are placed on a tray and placed in an environment with a temperature of 15-30°C and a humidity of 20-35%. When the moisture content of the rubber reaches 3-10%, the soft capsules are collected and the coating is completed.

7. A soft capsule coating agent according to claim 6, characterized in that: In step S1, when adding the coating agent raw material, the coating agent raw material is added to the center of the vortex formed by stirring; after all the coating agent raw materials are added, the stirring speed is reduced to make the vortex disappear.

8. A soft capsule coating agent according to claim 6, characterized in that: In step S2: in the drum of the coating machine, the spray gun pressure is 0.23-0.6 MPa, the atomization pressure is 0.4-0.8 MPa, and the flattening pressure is 0.25-0.5 MPa.

9. A soft capsule, comprising a soft capsule shell and contents contained in the soft capsule shell, characterized in that: The surface of the soft capsule shell has a coating formed of the soft capsule coating agent according to any one of claims 1 to 5.

10. The soft capsule according to claim 9, characterized in that The mass of the coating accounts for 0.5-1.5 wt % of the total mass of the soft capsule shell and the contents.

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