A soft capsule with enhanced immunity and antioxidation and a preparation method thereof

By detecting the stress of the stirring paddle and the distance between the colloids, adjusting the stirring speed and swirling intensity, and refining the degassing process and compression strength, the problems of uneven mixing and high cost in soft capsule preparation have been solved, and the efficient preparation of soft capsules that enhance immunity and have antioxidant properties has been achieved.

CN120860900BActive Publication Date: 2025-12-23CHENGDU RUNXINTANG PHARMA
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Patent Information

Application Number
CN202511411033.X
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2025-09-29
Publication Date
2025-12-23
Estimated Expiration
2045-09-29

AI Technical Summary

Technical Problem

Existing soft capsule preparation technologies cannot respond to changes in material state in real time, resulting in uneven mixing, capsule cap sealing errors, and high costs, and cannot simultaneously meet the needs of enhancing immunity and anti-oxidation.

Method used

By detecting the stress of the stirring paddle and the distance between the colloids, adjusting the stirring paddle speed and swirling intensity, and refining the defoaming process and pressing intensity, we ensure the uniformity of mixing and the quality of the capsules. We also use grape seed extract, astaxanthin oil and natural vitamin E to synergistically enhance immunity and antioxidant effects.

Benefits of technology

This achieves improved uniformity of soft capsule ingredients, reduces oxidative loss, extends shelf life, meets the needs for enhanced immunity and antioxidant effects, and reduces production costs.

✦ Generated by Eureka AI based on patent content.

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Abstract

The present application relates to soft capsule preparation technical field, especially to a kind of soft capsules of enhancing immunity, antioxidant and preparation method thereof, preparation method includes: auxiliary material is placed into stirring equipment and is mixed heating stirring;Stress and the linear distance of glue mass and stirring paddle are detected respectively;According to stress and linear distance, determine the risk of sticking of glue mass protrusion;Determine the rotational flow intensity coefficient of inner rotational flow area of test mixture;Determine the rotating speed of stirring paddle;According to the rotating speed of stirring paddle, the actual mixing heating stirring of auxiliary material is carried out;Defoaming treatment is carried out;In turn, filtering, heat preservation and standing are carried out to output glue liquid, and glue liquid cooling shaping treatment forms upper glue cap and lower glue cap;According to the difference of intensity coefficient, the pressing strength of upper glue cap and lower glue cap is determined;According to the pressing strength, upper glue cap and lower glue cap are pressed to form the soft capsule of enhancing immunity, antioxidant.The present application realizes the promotion of the uniformity, stability and reliability of product quality.
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Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of soft capsule preparation, in particular to a soft capsule for enhancing immunity and resisting oxidation and a preparation method thereof. BACKGROUND

[0002] The soft capsule preparation method in the prior art is usually based on preset fixed process parameters such as fixed stirring speed, fixed stirring time, fixed defoaming time and fixed compression pressure. Once the parameters are set, they will not be changed in the production process. The real-time changes of the material state cannot be responded. When abnormal conditions such as gel and uneven mixing occur, the system cannot automatically detect and correct, and the problem can only be found after the process is completed, resulting in waste products. Quality control relies on destructive sampling detection of the final product. This is a post-repair quality control mode. Once the problem is detected, the entire batch of products may need to be scrapped or reworked, causing great waste. In the prior art, enhancing immunity and resisting oxidation are usually developed as two kinds of nutritional products, which not only cannot meet the needs of people who need to enhance immunity and resist oxidation at the same time, but also increase the cost of research and development and production.

[0003] Chinese Patent Publication No. CN103284153A discloses a soft capsule of cod liver oil and a preparation method thereof. Each 1000 soft capsules contain 450-540g of cod liver oil and 0.45-0.55g of natural vitamin E. Since cod liver oil contains ω-3 fatty acids that are prone to oxidation and deterioration, the product uses fat-soluble natural vitamin E as an antioxidant. To ensure that the microbial indicators meet the requirements, the weighing, sol, ingredients, pill compression, shaping and drying are all completed in a 10 million level clean area. Long-term stability tests show that the product is stable within the effective period of two years, the effective ingredient content, microbial indicators and properties meet the requirements, and the soft capsule shell does not harden or deteriorate. It can be seen that the soft capsule of cod liver oil and the preparation method thereof have the problems of slow stirring speed of the paddle arm of the stirring paddle due to the adhesion of the agglomerates of the auxiliary materials to the paddle arm during the oblique stirring of the auxiliary materials by the stirring paddle, and the existence of mixing differences between the inner rotating flow area and the outer stirring area of the auxiliary materials due to the falling of the agglomerates adhered to the stirring paddle and the formation of the inner rotating flow area under the paddle arm of the stirring paddle due to the stress of the auxiliary materials on the stirring paddle, which causes errors in the fitting process of the prepared capsule cap. SUMMARY

[0004] Therefore, the present invention provides a method for preparing soft capsules that enhance immunity and have antioxidant properties, in order to overcome the problems in the prior art where, during the oblique stirring of the excipients by the stirring paddle, clumps of excipients adhere to the stirring paddle, causing the stirring speed of the stirring paddle arm to slow down, and when the stress of the excipients on the stirring paddle causes the clumps adhering to the stirring paddle to fall off, thus forming an inner swirling region under the stirring paddle arm, resulting in a mixing difference between the excipients in the inner swirling region and the outer stirring region, which leads to errors in the sealing process of the capsule caps.

[0005] To achieve the above objectives, in one aspect, the present invention provides a method for preparing soft capsules that enhance immunity and have antioxidant properties, comprising:

[0006] The auxiliary materials are placed in a mixing device for mixing, heating, and stirring to output a test mixture;

[0007] The stress of the stirring paddle in the stirring device and the straight-line distance between the colloidal particles in the test mixture and the stirring paddle were measured respectively.

[0008] The risk of lumps protruding and adhering in the non-sharp stirring area corresponding to the stirring paddle is determined based on the stress and the straight-line distance.

[0009] The swirling intensity coefficient of the internal swirling flow of the test mixture is determined based on the duration of the risk of adhesion of the colloid protrusions and the current stirring speed of the agitator.

[0010] The rotational speed of the stirring paddle is determined based on the difference between the swirling intensity coefficient of the internal swirling flow of the test mixture and the intensity coefficient of the swirling flow in the sharp stirring region.

[0011] The auxiliary materials are actually mixed, heated, and stirred according to the rotation speed of the stirring paddle to output a basic mixture;

[0012] The base mixture is degassed to output a degassed mixture;

[0013] The degassing mixture is sequentially filtered, kept at a constant temperature and allowed to stand to output the adhesive liquid, and the adhesive liquid is cooled and shaped to form an upper adhesive cap and a lower adhesive cap respectively;

[0014] The pressing strength between the upper and lower rubber caps is determined based on the difference in strength coefficients.

[0015] The lower capsule is filled with raw materials containing grape seed extract, astaxanthin oil, and natural vitamin E oil, and the upper and lower capsules are pressed together according to the specified pressing strength to form a soft capsule that enhances immunity and provides antioxidant benefits.

[0016] Further, the step of determining the risk of the lumps sticking to the convexity of the non-sharp stirring area corresponding to the stirring blade according to the stress and the straight-line distance comprises:

[0017] acquiring the maximum stirring force required for breaking the lumps smaller than the preset distance;

[0018] comparing the stress with the maximum stirring force;

[0019] if the stress is greater than the maximum stirring force, determining that the risk of the lumps sticking to the inner vortex corresponding to the stirring blade exceeds the allowable range.

[0020] Further, the vortex intensity coefficient of the sharp stirring area is a first actual rotating speed of the stirring blade at a first moment; and the vortex intensity coefficient of the inner vortex is a rotating speed difference value between a second actual rotating speed of the stirring blade at a second moment and a third actual rotating speed of the stirring blade at a third moment.

[0021] Further, the third actual rotating speed of the stirring blade is greater than the second actual rotating speed of the stirring blade and smaller than the first actual rotating speed of the stirring blade; the first moment is earlier than the second moment, and the second moment is earlier than the third moment.

[0022] Further, the step of determining the rotating speed of the stirring blade based on the intensity coefficient difference value between the vortex intensity coefficient of the inner vortex and the vortex intensity coefficient of the sharp stirring area of the test mixture comprises:

[0023] respectively acquiring the vortex intensity coefficient of the sharp stirring area and the vortex intensity coefficient of the inner vortex;

[0024] calculating the intensity coefficient difference value between the vortex intensity coefficient of the sharp stirring area and the vortex intensity coefficient of the inner vortex;

[0025] comparing the intensity coefficient difference value with a preset intensity coefficient difference value;

[0026] if the intensity coefficient difference value is greater than the preset intensity coefficient difference value, reducing the rotating speed of the stirring blade.

[0027] Further, the rotating speed of the stirring blade and the intensity coefficient difference value are in a negative correlation.

[0028] Further, if the intensity coefficient difference value is greater than the preset intensity coefficient difference value, simultaneously increasing the pressing strength of the upper glue cap and the lower glue cap.

[0029] Further, the pressing strength and the intensity coefficient difference value are in a positive correlation.

[0030] Further, when the intensity coefficient difference is greater than a preset intensity coefficient difference, the defoaming time length of the base mixture of the inner rotating flow is greater than the defoaming time length of the base mixture of the sharp stirring area.

[0031] The application further provides a soft capsule for enhancing immunity and resisting oxidation, and ingredients of 0.6g / piece, 1000 pieces in total include: auxiliary materials: 380g of soybean oil, 100g of purified water, 100g of gelatin, 40g of glycerol, 18g of beeswax, 0.6g of cochineal, and 0.3g of titanium dioxide; raw materials: 80g of grape seed extract, 50g of astaxanthin oil, 30g of natural vitamin E oil, 30g of lycopene oil, and 12g of lutein oil.

[0032] Compared with the prior art, the present application has the beneficial effects that the risk of the lumps sticking to the convex of the non-sharp stirring area of the stirring paddle corresponding to the stirring paddle is determined by the stress of the stirring paddle and the straight-line distance between the lumps in the test mixture and the stirring paddle, and after the gelatin powder is added, the lumps that cannot be dispersed in time swell and gelate rapidly due to the water in the outer layer, forming a viscous protective layer to wrap the dry powder in the inside, forming lumps that cannot be dissolved, the present application realizes the monitoring, identification and early warning of the risk of the lumps sticking to the convex by judging the risk of the lumps sticking to the convex according to the stress of the stirring paddle and the straight-line distance between the lumps in the test mixture and the stirring paddle; the rotation speed of the stirring paddle is determined by setting the rotational flow intensity coefficient and according to the difference between the rotational flow intensity coefficient of the inner rotational flow and the rotational flow intensity coefficient corresponding to the sharp stirring area, and in the stirring process, the lumps stick to the stirring paddle, so that the resistance of the inner rotational flow corresponding to the non-sharp part of the stirring paddle increases, resulting in that the rotational flow intensity of the inner rotational flow is less than the rotational flow intensity of the sharp stirring area corresponding to the sharp part of the stirring paddle. When the difference between the rotational flow intensity coefficient of the inner rotational flow and the rotational flow intensity coefficient corresponding to the sharp stirring area exceeds the allowable range, it indicates that there is a large difference in the stirring capacity between the non-sharp stirring area and the sharp stirring area, resulting in a difference in the mixing effect of the test mixture in the inner rotational flow and the test mixture in the sharp stirring area. At this time, the rotation speed of the stirring paddle is adjusted according to the difference in the mixing effect of the test mixture in the inner rotational flow and the test mixture in the sharp stirring area, the present application realizes the monitoring of the difference in the mixing effect of the test mixture in the inner rotational flow and the test mixture in the sharp stirring area, and adjusts the rotation speed of the stirring paddle according to the difference in the mixing effect of the test mixture in the inner rotational flow and the test mixture in the sharp stirring area, thereby improving the uniformity of the stirring product; the length of time used for adjusting the defoaming treatment is set, and in the defoaming process, when the difference between the rotational flow intensity coefficient of the inner rotational flow and the rotational flow intensity coefficient corresponding to the sharp stirring area exceeds the allowable range, the stirring capacity of the inner rotational flow is weak, resulting in poor mixing effect of the basic mixture in the inner rotational flow and large amount of residual bubbles, and the length of time required for defoaming treatment is longer, thereby realizing the reduction of the amount of bubbles in the defoamed mixture; the adjustment of the compression strength is set, and in the process of compressing and granulating the upper and lower gum caps, when the intensity coefficient difference is greater than the preset intensity coefficient difference, it indicates that there is a difference in the mixing performance of the upper and lower gum caps, and the quality of the upper gum cap or the lower gum cap made of the mixture in the inner rotational flow of the basic mixture is poor. In order to prevent the upper and lower gum caps from separating after compression, the compression strength of the upper and lower gum caps is adjusted to enhance the bonding capacity of the upper and lower gum caps, thereby improving the quality of the soft capsule particles.

[0033] Further, by acquiring the maximum stirring force required to break the micelles smaller than the preset distance, the stress on the stirring paddle is compared with the maximum stirring force, when the stress is smaller than the maximum stirring force, it indicates that the stirring force is not enough to break all the micelles smaller than the preset distance, at this time, there will be micelles adhering to the non-sharp part of the stirring paddle, resulting in the decrease of the rotational flow intensity of the inner rotational flow, realizing the quantitative monitoring and judgment identification of the risk of micelle convex adhesion.

[0034] Further, by setting a preset intensity coefficient difference, during the stirring process, the difference between the rotational flow intensity coefficient of the inner rotational flow and the rotational flow intensity coefficient corresponding to the sharp stirring area is compared with the preset difference, when the difference between the rotational flow intensity coefficient of the inner rotational flow and the rotational flow intensity coefficient corresponding to the sharp stirring area is greater than the preset difference, it indicates that there is a large difference in the stirring ability between the non-sharp stirring area and the sharp stirring area, resulting in the difference in the mixing effect of the mixture in the inner rotational flow and the mixture in the sharp stirring area exceeding the allowable range, at this time, the rotation speed of the stirring paddle should be reduced to cope with it, realizing the weakening of the adverse flow field and preventing the further deterioration of the micelles, creating a quantitative benchmark for subsequent adjustment.

[0035] Further, by determining the pressing strength of the upper and lower rubber caps according to the intensity coefficient difference, during the pressing process, when the intensity coefficient difference between the rotational flow intensity coefficient of the sharp stirring area and the rotational flow intensity coefficient of the inner rotational flow is greater than the preset intensity coefficient difference, it indicates that the difference in the mixing performance of the upper and lower rubber caps does not meet the requirements, the quality of the upper and lower rubber caps made of the basic mixture in the inner rotational flow is poor, in order to prevent the separation of the upper and lower rubber caps after pressing, the pressing strength of the upper and lower rubber caps is increased to enhance the bonding ability of the upper and lower rubber caps, realizing the compensation for the material inconsistency caused by the front-end manufacturing, and improving the quality of the soft capsule particles.

[0036] Further, by fine management of the defoaming treatment time, the batch of basic mixture whose difference between the rotational flow intensity coefficient of the inner rotational flow and the rotational flow intensity coefficient of the sharp stirring area is greater than the preset intensity coefficient difference is identified. Due to the too large difference in the mixing performance, the amount of entrained bubbles is too large, which requires a longer defoaming time, realizing the targeted elimination of bubbles and further improving the quality of the soft capsule particles.

[0037] Further, specific solutions for synergistically enhancing immunity and antioxidant capacity are provided: In the ingredients, grape seed extract, astaxanthin, lycopene and lutein are powerful antioxidants, and natural vitamin E is both antioxidant and immune boosting. The present application realizes synergistic effect through the compounding of multiple functional ingredients, and at the same time meets two kinds of needs. The preparation process ensures that the active ingredients are perfectly sealed in high-quality capsules, reduces the oxidation loss in the production process, and prolongs the shelf life and efficacy durability of the product.

[0038] Further, the core component of grape seed extract is proanthocyanidin, especially oligomeric proanthocyanidin, which is one of the most powerful natural antioxidants ever discovered. Its antioxidant activity is much stronger than that of vitamin C and vitamin E, and it can effectively scavenge free radicals in the human body, reduce oxidative stress damage to cell membranes, DNA and proteins. Protect vascular endothelial cells, enhance vascular elasticity, improve blood circulation, thereby delaying aging and having antioxidant effects. The core component of astaxanthin oil is astaxanthin, which is a ketocarotenoid belonging to the carotenoid family. It is known as the strongest antioxidant in nature. Its molecular structure allows it to exist in both the inner and outer layers of the cell membrane, protecting the entire cell from oxidative damage. Its ability to scavenge free radicals far exceeds that of beta-carotene, lycopene and vitamin E. Astaxanthin can significantly enhance the body's humoral and cellular immune responses. It can promote the production of immunoglobulins and increase the number and activity of immune cells such as T cells, B cells and natural killer cells, thereby enhancing the body's immune function. The core component of natural vitamin E oil is d-alpha-tocopherol, which is the most biologically active form of vitamin E and is also a major fat-soluble antioxidant that protects cell membranes from lipid peroxidation, interrupts the chain reaction of lipid peroxidation, and protects the integrity and stability of cell membranes. Vitamin E is a key nutrient for maintaining immune system health, can enhance the function of T lymphocytes, and improve the body's resistance to pathogens, thereby enhancing immunity and antioxidant effects. This formula scientifically covers both water-soluble and fat-soluble environments, providing comprehensive antioxidant protection from basic nutrition to top specialties such as astaxanthin and OPCs. The ingredients support, regenerate and supplement each other, forming a powerful antioxidant network and immune support system. Not only does it effectively neutralize various free radicals and slow down oxidative aging, but it also protects immune cells and enhances immune organ function, fundamentally improving the body's overall immunity. At the same time, the intelligent preparation process of the present application maximizes the efficacy of these active ingredients and ensures that they are perfectly sealed in capsules for direct efficacy in the human body. BRIEF DESCRIPTION OF DRAWINGS

[0039] Figure 1 Preparation flowchart of the soft capsule preparation method for enhancing immunity and antioxidant of the embodiment of the present application;

[0040] Figure 2 Structure schematic diagram of the stirring pot 2 of the soft capsule preparation method for enhancing immunity and antioxidant of the embodiment of the present application;

[0041] Figure 3 Flowchart for determining the rotation speed of the stirring paddle based on the difference between the intensity coefficient of the inner rotational flow of the test mixture and the intensity coefficient of the rotational flow of the sharp stirring area of the soft capsule preparation method for enhancing immunity and antioxidant of the embodiment of the present application;

[0042] Figure 4 Flow chart for determining the risk of agglomerate protrusion adhesion of the non-sharp stirring area corresponding to the stirring paddle according to stress and straight-line distance for the preparation method of the soft capsule for enhancing immunity and antioxidation of the embodiment of the present application;

[0043] The reference signs are as follows: 1-ultrasonic ranging sensor, 2-stirring pot, 3-feeding port, 4-stress sensor, 5-stirring paddle, 6-discharging port, 7-sharp stirring area, 8-inner cyclone area. DETAILED DESCRIPTION

[0044] In order to make the objects and advantages of the present application clearer, the present application will be further described in conjunction with embodiments. It should be understood that the specific embodiments described herein merely serve to explain the present application and should not be used to limit the present application.

[0045] The preferred embodiments of the present application will be described below with reference to the accompanying drawings. It should be understood by those skilled in the art that these embodiments merely serve to explain the technical principles of the present application and are not intended to limit the protection scope of the present application.

[0046] It should be noted that, in the description of the present application, the terms indicating the direction or positional relationship such as "upper", "lower", "left", "right", "inner", "outer", etc. are based on the direction or positional relationship shown in the drawings, which is merely for the convenience of description and does not indicate or imply that the device or element must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present application; in addition, it should be noted that, in the description of the present application, unless otherwise explicitly specified and limited, the terms "mounting", "connection", "connecting" should be understood in a broad sense, for example, it can be fixed connection, or detachable connection, or integrally connected; it can be mechanical connection, or electrical connection; it can be directly connected, or indirectly connected through an intermediate medium, or the communication between the two elements inside. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.

[0047] Please refer to Figure 1 , Figure 2 , Figure 3 and Figure 4 , which are respectively the preparation flow chart of the preparation method of the soft capsule for enhancing immunity and antioxidation of the embodiment of the present application, the structure schematic diagram of the stirring pot 2, the flow chart of determining the rotating speed of the stirring paddle based on the intensity coefficient difference between the cyclone intensity coefficient of the inner cyclone of the test mixture and the cyclone intensity coefficient of the sharp stirring area, and the flow chart of determining the risk of agglomerate protrusion adhesion of the non-sharp stirring area corresponding to the stirring paddle according to stress and straight-line distance.

[0048] The application discloses a preparation method of soft capsules with enhanced immunity and oxidation resistance.

[0049] Step S1: placing the auxiliary materials into a stirring device for mixing, heating and stirring to output a test mixture;

[0050] Specifically, the stirring device is a variable-frequency homogenizing stirring pot 2.

[0051] Specifically, the stirring device comprises:

[0052] a stirring paddle 5 for transmitting a stirring torque to the auxiliary materials;

[0053] a stirring motor connected with the stirring paddle 5 for providing a stirring power to the auxiliary materials;

[0054] an ultrasonic ranging sensor 1 arranged above the fan blade of the stirring paddle 5 for detecting a straight-line distance between the test mixture and the stirring paddle 5;

[0055] a stress sensor 4 arranged on the fan blade of the stirring paddle 5 for detecting a stress received by the fan blade of the stirring paddle 5.

[0056] Specifically, the optional range of the heating temperature is 78-82 DEG C, the rated rotating speed of the stirring motor is 250-350 rpm, and the preferred embodiment of the heating temperature is 80 DEG C.

[0057] Step S2: detecting the stress of the stirring paddle 5 in the stirring device and the straight-line distance between the test mixture and the stirring paddle 5 respectively;

[0058] In the implementation, the stress sensor 4 is used to monitor the stress received by the stirring paddle 5 in the stirring process in real time, the stress sensor 4 is arranged on a non-sharp part of the stirring paddle 5 and stretches and contracts together with the stirring paddle 5, and the ultrasonic ranging sensor 1 is used to measure the distance between the test mixture and the stirring paddle 5, and the ultrasonic ranging sensor 1 is arranged above the fan blade of the stirring paddle 5.

[0059] Step S3: determining the risk of the adhesion of the gelatin lumps on the non-sharp stirring area of the stirring paddle 5 according to the stress and the straight-line distance, comprising:

[0060] acquiring a maximum stirring force required for breaking the gelatin lumps smaller than a preset distance;

[0061] comparing the stress with the maximum stirring force;

[0062] if the stress is greater than the maximum stirring force, it is determined that the risk of the adhesion of the gelatin lumps on the non-sharp stirring area of the stirring paddle 5 exceeds an allowable range.

[0063] Optionally, the optional embodiment of the preset distance ranges from 3 cm to 5 cm, and the preferred embodiment is 4 cm. The diameter of the globule smaller than the preset distance is obtained, and the stirring force required for the globule to be broken is obtained according to the product of the globule diameter and the conversion coefficient; wherein the conversion coefficient is a constant reflecting the conversion ratio of the globule diameter to the stirring force required for the globule to be broken, and the optional range of the conversion coefficient is [4 N / cm, 6 N / cm], and the preferred embodiment of the conversion coefficient is 5 N / cm.

[0064] Specifically, during the stirring process, due to the different shear forces caused by the sharp part and the non-sharp part of the stirring paddle 5, after the gelatin powder is added, the outer layer swells and gels rapidly after meeting water, forming a viscous protective layer, which wraps the internal dry powder, forming a globule that cannot be dissolved. The present application determines the risk of globule protrusion adhesion according to the stress of the stirring paddle 5 and the linear distance between the globule in the test mixture and the stirring paddle 5. The monitoring, identification and early warning of the risk of globule protrusion adhesion are as follows: if the actual detection stress is greater than or equal to the standard stirring force, the core reason is that the globule has been partially adhered to the non-sharp part; the adhered globule will rotate synchronously with the stirring paddle 5, breaking the normal balance of the globule being driven by the fluid, causing the stirring paddle 5 to overcome the additional resistance of the globule adhesion, so the actual stress exceeds the standard value. By obtaining the maximum stirring force required for the globule smaller than the preset distance to be broken, the stress on the stirring paddle 5 is compared with the maximum stirring force. When the stress is greater than the maximum stirring force, it means that the stirring force is not enough to break all the globules smaller than the preset distance, and at this time, the globule will adhere to the non-sharp part of the stirring paddle 5, forming globule protrusion adhesion, and at this time, it is determined that the risk of globule protrusion adhesion of the inner rotational flow area 8 corresponding to the stirring paddle 5 exceeds the allowable range.

[0065] Step S4: determining the rotational flow intensity coefficient of the inner rotational flow of the test mixture according to the duration of the risk of globule protrusion adhesion and the current stirring speed of the stirring paddle 5, comprising:

[0066] In implementation, the inner rotational flow area 8 is a weak rotational flow area formed when the non-sharp area has an adhesion risk, and the globule hinders the local fluid flow, causing the rotational flow intensity of the area to decrease.

[0067] Specifically, the stirring speed of the stirring paddle 5 is directly read by the gyroscope built in the stirring pot 2.

[0068] Specifically, the first time point is the time point when the stirring speed of the stirring blade 5 is monitored; the second time point is the time point when the gel movement in the test mixture adheres to the stirring blade 5 blade wall, and the volume of the gel formed on the stirring blade 5 blade wall no longer increases; when the stress gradually increases to be greater than the maximum stirring force, at this time, the stress transmitted to the stirring blade 5 by the test mixture is sufficient to make the adhered gel on the stirring blade 5 fall off through vibration, so that the adhered gel on the stirring blade 5 gradually falls off with the increase of the stress, and because the stirring blade 5 rotates, and the oblique stirring process of the stirring blade 5 forms a relatively closed rotating area below the blade wall, the gel falling off from the blade wall of the stirring blade 5 is easy to rotate in the relatively closed rotating area to form an inner rotating flow area 8, and the time point when all the adhered gel on the blade wall of the stirring blade 5 falls off is recorded as the third time point; the third actual rotating speed of the stirring blade 5 is detected at the third time point.

[0069] The skilled in the art can understand that the change amount of the stirring speed of the stirring blade 5 in the time period from the second time point to the third time point can reflect the strength of the inner rotating flow area 8 formed in this time period, and the rotating flow strength coefficient of the sharp stirring area is represented by the first actual rotating speed of the stirring blade 5 at the first time point, which can reflect the rotating strength of the maximum rotating flow, and by comparing the rotating flow strength coefficient of the sharp stirring area with the rotating flow strength coefficient of the inner rotating flow area 8, the state of the stirring of the auxiliary material can be accurately reflected.

[0070] Step S5: determining the rotating speed of the stirring blade 5 based on the strength coefficient difference between the rotating flow strength coefficient of the inner rotating flow area 8 of the test mixture and the rotating flow strength coefficient of the sharp stirring area;

[0071] respectively acquiring the rotating flow strength coefficient of the sharp stirring area and the rotating flow strength coefficient of the inner rotating flow area 8;

[0072] calculating the strength coefficient difference between the rotating flow strength coefficient of the sharp stirring area and the rotating flow strength coefficient of the inner rotating flow area 8;

[0073] comparing the strength coefficient difference with a preset strength coefficient difference;

[0074] if the strength coefficient difference is greater than the preset strength coefficient difference, reducing the rotating speed parameter of the stirring blade 5.

[0075] The rotating speed of the stirring blade 5 is in a negative correlation relationship with the strength coefficient difference.

[0076] Optionally, the optional range of the preset strength coefficient difference is [5 rpm, 7 rpm], and the preferred embodiment of the preset difference is 6 rpm.

[0077] In the implementation, when the difference between the rotational flow intensity coefficient of the inner rotational flow region 8 and the rotational flow intensity coefficient of the sharp stirring region 7 exceeds the preset intensity coefficient difference value by a value within 2 rpm, the rotational speed of the stirring paddle 5 is adjusted to 0.97 times the current rotational speed of the stirring paddle 5, and the rotational speed of the stirring paddle 5 is reduced by 0.01 times for each 1 rpm that the intensity coefficient difference exceeds the preset intensity coefficient difference value. In a specific embodiment, the intensity coefficient difference between the rotational flow intensity coefficient of the inner rotational flow region 8 and the rotational flow intensity coefficient of the sharp stirring region is 9 rpm, the preset intensity coefficient difference value is 6 rpm, and the current rotational speed of the stirring paddle 5 is 300 rpm. Then, the reduced rotational speed of the stirring paddle 5 is 300 rpm x [0.97 - (9 rpm - 6 rpm - 2 rpm) x 0.01] = 288 rpm.

[0078] In the implementation, the sharp stirring region 7 is a region corresponding to the blade edge and the tip of the stirring paddle 5, which has high linear velocity and strong fluid shear force and no fluid dead angle. The gelatin particles, beeswax crystals, and other easy-to-agglomerate components in the auxiliary materials can be quickly dispersed by the high-speed rotational flow, and the glue liquid has good mixing uniformity and stable rotational flow state.

[0079] Specifically, the inner rotational flow region 8 is a region corresponding to the back of the blade and the transition between the blade and the shaft, i.e., a non-sharp stirring region, which has low linear velocity and is prone to form dead angles and has a high risk of agglomeration. Once there is a risk of agglomeration, it will directly hinder the flow of fluid, causing the rotational flow intensity in this region to decrease and the mixing efficiency to decrease, becoming a weak mixing area.

[0080] At high rotational speeds, the inner rotational flow region 8 is prone to form local vortex collisions, which can exacerbate agglomeration. After appropriately reducing the rotational speed, the fluid flow is more stable, and the collision can be reduced, making it easier for the agglomerates to be carried away from the inner rotational flow region 8 by the fluid, thereby reducing the risk of agglomeration.

[0081] In the implementation, the step is achieved by setting the rotational flow intensity coefficient, and determining the rotating speed of the stirring paddle 5 according to the difference between the rotational flow intensity coefficient of the inner rotational flow area 8 and the rotational flow intensity coefficient corresponding to the sharp stirring area 7. In the stirring process, the colloidal particles adhere to the stirring paddle 5, so that the resistance of the inner rotational flow area 8 corresponding to the non-sharp part of the stirring paddle 5 increases, resulting in that the rotational flow intensity of the inner rotational flow area 8 is less than the rotational flow intensity of the sharp stirring area 7 corresponding to the sharp part of the stirring paddle 5. When the difference between the rotational flow intensity coefficient of the inner rotational flow area 8 and the rotational flow intensity coefficient corresponding to the sharp stirring area 7 exceeds the allowable range, it indicates that there is a large difference in the stirring capacity between the inner rotational flow area 8 and the sharp stirring area 7, resulting in a difference in the mixing effect of the test mixture in the inner rotational flow area 8 and the test mixture in the sharp stirring area 7. At this time, the rotating speed of the stirring paddle 5 is adjusted according to the difference in the mixing effect of the test mixture in the inner rotational flow area 8 and the test mixture in the sharp stirring area 7. The present application realizes the monitoring of the difference in the mixing effect of the test mixture in the inner rotational flow area 8 and the test mixture in the sharp stirring area 7, and adjusts the rotating speed of the stirring paddle 5 according to the difference in the mixing effect of the test mixture in the inner rotational flow area 8 and the test mixture in the sharp stirring area 7, thereby improving the uniformity of the stirring product, and making the enhanced immunity and antioxidant effect of the final product more stable. The uneven mixing is eliminated before the glue output, so as to avoid that the unqualified glue enters the defoaming and cooling shaping process, and the unevenly mixed glue can cause the rubber skin to be broken and leaked, so that the active ingredients such as grape seed extract and astaxanthin are oxidized and invalid.

[0082] Step S6: actually mixing and heating the auxiliary materials according to the rotating speed of the stirring paddle 5 to output the basic mixture;

[0083] The ingredients of 1000 soft capsules of 0.6g / capsule include:

[0084] Auxiliary materials: soybean oil 380g, purified water 100g, gelatin 100g, glycerol 40g, beeswax 18g, cochineal 0.6g, titanium dioxide 0.3g;

[0085] Specifically, the actual mixing and heating stirring time is 5-10 minutes.

[0086] Step S7: defoaming treatment is performed on the basic mixture to output a defoamed mixture;

[0087] When the intensity coefficient difference is greater than the preset intensity coefficient difference, the defoaming time of the basic mixture in the inner rotational flow area 8 is greater than the defoaming time of the basic mixture in the sharp stirring area.

[0088] In the implementation, when the difference between the rotational flow intensity coefficient of the inner rotational flow region 8 and the rotational flow intensity coefficient corresponding to the sharp stirring region 7 exceeds the preset intensity coefficient difference by a value within 2 rpm, the current defoaming duration is increased by 1 minute, and when the difference between the rotational flow intensity coefficient of the inner rotational flow region 8 and the rotational flow intensity coefficient corresponding to the sharp stirring region 7 exceeds the preset intensity coefficient difference by 2 rpm, the defoaming duration is increased by 0.1 minute for each excess of 1 rpm. In a specific embodiment, the difference between the rotational flow intensity coefficient of the inner rotational flow region 8 and the rotational flow intensity coefficient corresponding to the sharp stirring region is 10 rpm, the preset difference is 6 rpm, and the current defoaming duration is 20 minutes. Then, the increased defoaming duration is 20 min + 1 min [(10 rpm - 6 rpm - 2 rpm) ÷ 1 rpm x 0.1 min] = 21.2 min.

[0089] The defoaming process temperature is consistent with the stirring process temperature, and the stirring of 20-25 rpm is applied.

[0090] This step adjusts the defoaming treatment duration. In the defoaming process, when the difference between the rotational flow intensity coefficient of the inner rotational flow region 8 and the rotational flow intensity coefficient corresponding to the sharp stirring region exceeds the allowed range, the stirring ability of the inner rotational flow region 8 is weak, resulting in poor mixing effect of the base mixture in the inner rotational flow region 8 and large amount of residual bubbles, and the defoaming treatment duration is longer. The defoaming mixture bubble amount is reduced. Through fine management of the defoaming treatment duration, the base mixture batch with the difference between the rotational flow intensity coefficient of the inner rotational flow region 8 and the rotational flow intensity coefficient of the sharp stirring region greater than the preset intensity coefficient difference is identified. The base mixture batch has a large difference in mixing performance, resulting in a large amount of entrained bubbles, and requires a longer defoaming time. The bubbles are eliminated in a targeted manner, and the soft capsule particle quality is further improved.

[0091] Step S8: sequentially filtering and heat standing the defoaming mixture to output the glue liquid, and cooling and shaping the glue liquid to form upper and lower glue caps, respectively;

[0092] In the implementation, a double-layer precision filter is used in the filtering process, and the filtering area needs to match the glue liquid delivery amount. The first filter core is 100 mesh to remove particles larger than 0.15 mm, and the second filter core is 200 mesh to remove particles larger than 0.075 mm. Food-grade polypropylene is selected as the material to avoid chemical reaction with cochineal and glycerol in the glue liquid. The filtering pressure is 0.1-0.15 MPa, and the temperature is maintained at 80°C.

[0093] The subsequent heat standing process maintains 80°C for 2-12 hours.

[0094] The cooling and shaping process adopts a double roller calender, and the semi-spherical cap concave rubber is pressed out from the heated roller with two counter-rotating cylindrical dies. The temperature, speed and distance of the roller directly determine the quality of the rubber, and need to be strictly matched with the size of the cap of the 0.6g / pellet soft capsule. The temperature is 80-82℃, the speed is 5-8m / min, and the distance is 0.3-0.4mm. Preferably, the temperature is 80℃, the speed is 6rpm, and the distance is 0.3mm.

[0095] The quantitative delivery pump is used to uniformly deliver the rubber solution after standing and keeping warm to the roller feeding port, and the delivery amount is matched with the roller speed.

[0096] The rotary die cutting machine is used to cut the continuous rubber into circular cap blanks matched with the size of the soft capsule, and to distinguish the upper cap with concave and the lower cap with convex. The size accuracy of the two directly determines the matching degree of the subsequent compression. The cutting efficiency is 100 per minute, and the die needs to be customized according to the 0.6g / pellet specification;

[0097] Step S9: determining the compression strength of the upper cap and the lower cap according to the strength coefficient difference

[0098] If the strength coefficient difference is greater than the preset strength coefficient difference, the compression strength of the upper cap and the lower cap is increased.

[0099] The compression strength and the strength coefficient difference are in a positive correlation.

[0100] When the strength coefficient difference is less than or equal to the preset strength coefficient difference, the conventional compression strength is used; wherein the conventional compression strength is 0.3MPa.

[0101] When the strength coefficient difference is greater than or equal to the preset strength coefficient difference, the compression strength is increased.

[0102] Specifically, if the strength coefficient difference is greater than the preset strength coefficient difference within rpm, the compression strength of the upper cap and the lower cap is adjusted to 1.05 times of the current compression strength of the upper cap and the lower cap. If the strength coefficient difference is greater than the preset strength coefficient difference by more than 1rpm, the compression strength of the upper cap and the lower cap is increased by 0.01 times for every 0.5rpm. In a specific embodiment, the strength coefficient difference is 5rpm, the preset strength coefficient difference is 3rpm, and the current compression strength of the upper cap and the lower cap is 0.3Mpa. Therefore, the increased compression strength of the upper cap and the lower cap is 0.3Mpa x [(5rpm-3rpm-1rpm) ÷ 0.5rpm x 0.01 + 1.05] = 0.321Mpa.

[0103] Specifically, by setting the adjustment compression strength, in the process of compression granulation of the upper and lower gum caps, when the intensity coefficient difference is greater than the preset intensity coefficient difference, it indicates that the mixing performance of the upper and lower gum caps is different, and the quality of the upper or lower gum cap made of the mixture in the inner rotational flow area 8 of the basic mixture is poor. In order to prevent the upper and lower gum caps from separating after compression, the compression strength of the upper and lower gum caps is adjusted to enhance the binding ability of the upper and lower gum caps, and the quality of the soft capsule particles is improved. By determining the compression strength of the upper and lower gum caps according to the intensity coefficient difference, when the intensity coefficient difference between the rotational flow intensity coefficient of the sharp stirring area and the rotational flow intensity coefficient of the inner rotational flow area 8 is greater than the preset intensity coefficient difference, it indicates that the difference in the mixing performance of the upper and lower gum caps does not meet the requirements, and the quality of the upper or lower gum cap made of the basic mixture in the inner rotational flow area 8 is poor. In order to prevent the upper and lower gum caps from separating after compression, the compression strength of the upper and lower gum caps is increased to enhance the binding ability of the upper and lower gum caps, and the quality of the soft capsule particles is improved.

[0104] Step S10: Fill the raw materials containing grape seed extract, astaxanthin oil and natural vitamin E oil into the lower gum cap, and compress the upper gum cap and the lower gum cap according to the compression strength to form soft capsules with enhanced immunity and antioxidant properties.

[0105] The embodiment of the present application also provides a soft capsule with enhanced immunity and antioxidant properties, and the raw material ingredients of 0.6g / particle, 1000 particles in total include:

[0106] Raw materials: grape seed extract 80g, astaxanthin oil 50g, natural vitamin E oil 30g, lycopene oil 30g, and lutein oil 12g.

[0107] In the implementation, an integrated soft capsule machine is used, and the raw materials are fully mixed and then placed into the integrated soft capsule machine for compression using the adjusted compression strength.

[0108] Thus, a soft capsule prepared by a soft capsule preparation method with enhanced immunity and antioxidant properties is prepared, and the raw materials of the soft capsule include grape seed extract, astaxanthin oil, natural vitamin E oil, lycopene oil, and lutein oil.

[0109] The core component of grape seed extract is proanthocyanidin, especially oligomeric proanthocyanidin, which is one of the strongest natural antioxidants discovered so far. Its antioxidant activity is much stronger than that of vitamin C and vitamin E, and it can efficiently scavenge free radicals in the human body and reduce the damage of oxidative stress to cell membranes, DNA and proteins. It protects vascular endothelial cells, enhances vascular elasticity, and improves blood circulation, thereby delaying aging and having antioxidant effects.

[0110] The core component of astaxanthin oil is astaxanthin, which is a ketocarotenoid belonging to the carotenoid family. It is known as the strongest antioxidant in nature. Its molecular structure allows it to exist in both the inner and outer layers of the cell membrane, protecting the entire cell from oxidative damage. Its ability to scavenge free radicals far exceeds that of beta-carotene, lycopene, and vitamin E. Astaxanthin can significantly enhance the body's humoral and cellular immune responses. It can promote the production of immunoglobulins and increase the number and activity of immune cells such as T cells, B cells, and natural killer cells (NK cells), thereby enhancing the body's immune function.

[0111] The core component of natural vitamin E oil is d-alpha-tocopherol, which is the most biologically active form of vitamin E and a major lipid-soluble antioxidant. It mainly protects cell membranes from lipid peroxidation damage, interrupts the chain reaction of lipid peroxidation, and protects the integrity and stability of cell membranes. Vitamin E is a key nutrient for maintaining immune system health, enhancing T lymphocyte function, and improving the body's resistance to pathogens, thereby enhancing immunity and antioxidant effects.

[0112] This formula is designed to scientifically cover both water-soluble and lipid-soluble environments, providing comprehensive antioxidant protection from basic nutrition to top specialties such as astaxanthin and OPCs. The components support, regenerate, and supplement each other, forming a powerful antioxidant network and immune support system.

[0113] The technical solutions of the present application have been described in combination with the preferred embodiments shown in the drawings, but those skilled in the art can easily understand that the protection scope of the present application is obviously not limited to these specific embodiments. Those skilled in the art can make equivalent changes or replacements to related technical features without departing from the principles of the present application, and the technical solutions after such changes or replacements will fall within the protection scope of the present application.

Claims

1. A method for preparing a soft capsule for enhancing immunity and antioxidation, the method comprising the steps of: The method comprises the following steps: ​ putting the auxiliary materials into a stirring device for mixing, heating and stirring to obtain a test mixture; detecting the stress of the stirring paddle in the stirring device and the linear distance between the test mixture and the stirring paddle, respectively; determining the risk of the test mixture in the non-sharp stirring area of the stirring paddle according to the stress and the linear distance; determining the intensity coefficient of the internal vortex of the test mixture according to the duration of the risk and the current stirring speed of the stirring paddle; determining the rotating speed of the stirring paddle based on the intensity coefficient difference between the intensity coefficient of the internal vortex of the test mixture and the intensity coefficient of the sharp stirring area; mixing, heating and stirring the auxiliary materials at the rotating speed of the stirring paddle to obtain a basic mixture; defoaming the basic mixture to obtain a defoamed mixture; filtering and heat-soaking the defoamed mixture in sequence to obtain a glue solution, and cooling and shaping the glue solution to form an upper glue cap and a lower glue cap, respectively; determining the pressing strength of the upper glue cap and the lower glue cap according to the intensity coefficient difference; filling raw materials containing grape seed extract, astaxanthin oil and natural vitamin E oil into the lower glue cap, and pressing the upper glue cap and the lower glue cap to form soft capsules with enhanced immunity and antioxidant capacity at the pressing strength. The intensity coefficient of the sharp stirring area is the first actual rotating speed of the stirring paddle at the first moment; the intensity coefficient of the internal vortex is the rotating speed difference between the second actual rotating speed of the stirring paddle at the second moment and the third actual rotating speed of the stirring paddle at the third moment. The third actual rotating speed of the stirring paddle is greater than the second actual rotating speed of the stirring paddle and less than the first actual rotating speed of the stirring paddle; the first moment is earlier than the second moment, and the second moment is earlier than the third moment.

2. The method of claim 1, wherein the soft capsule is prepared by the following steps: (1) mixing the ingredients of the soft capsule; (2) filling the mixture into a soft capsule; (3) drying the soft capsule; and (4) coating the soft capsule. The method comprises the following steps: obtaining the maximum stirring force required for the crushing of the glue balls smaller than the preset distance; comparing the stress with the maximum stirring force; if the stress is greater than the maximum stirring force, it is determined that the risk of the glue balls in the non-sharp stirring area of the stirring paddle exceeds the allowable range.

3. The method for preparing soft capsules with enhanced immunity and antioxidant properties according to claim 1, characterized in that, The method comprises the following steps: obtaining the intensity coefficient of the sharp stirring area and the intensity coefficient of the internal vortex, respectively; calculating the intensity coefficient difference between the intensity coefficient of the sharp stirring area and the intensity coefficient of the internal vortex; comparing the intensity coefficient difference with the preset intensity coefficient difference; if the intensity coefficient difference is greater than the preset intensity coefficient difference, the rotating speed of the stirring paddle is reduced.

4. The method for preparing the immune-enhancing and antioxidant soft capsules according to claim 3, characterized in that, The rotating speed of the stirring paddle is negatively correlated with the intensity coefficient difference.

5. The method for preparing soft capsules with enhanced immunity and antioxidant properties according to claim 4, characterized in that, If the intensity coefficient difference is greater than the preset intensity coefficient difference, the pressing strength of the upper glue cap and the lower glue cap is increased.

6. The method for preparing the immune-enhancing and antioxidant soft capsules according to claim 5, characterized in that, The pressing strength is positively correlated with the intensity coefficient difference.

7. The method for preparing the immune-enhancing and antioxidant soft capsules according to claim 6, characterized in that, When the intensity coefficient difference is greater than the preset intensity coefficient difference, the defoaming time required by the base mixture of the inner rotational flow is greater than the defoaming time of the base mixture of the sharp stirring area, and the defoaming time is increased accordingly.

Citation Information

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