High-stability soybean lecithin oily softgel capsule contents and preparation method thereof

WO2026202884A2PCT designated stage Publication Date: 2026-10-01ZIRAOUI NOUR-EDDINE
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Patent Information

Application Number
PCT/IB2026/057470
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Filing Date
2026-07-16
Publication Date
2026-10-01

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Abstract

The present invention discloses high-stability soybean lecithin oily softgel capsule contents and a preparation method thereof, and relates to the technical field of food functional ingredients and softgel capsule preparations. The oily softgel capsule contents, calculated on the basis of 100% by total weight, consist of: fluid soybean lecithin 74.0% to 76.0%; caprylic / capric triglyceride 23.5% to 25.5%; mixed tocopherols 0.30% to 0.36%; and L-ascorbyl palmitate 0.12% to 0.16%. According to the invention, caprylic / capric triglyceride is used to adjust the viscosity of the system, mixed tocopherols and L-ascorbyl palmitate are compounded as two antioxidant components to produce a synergistic effect, and the preparation is carried out in combination with low-temperature vacuum dehydration, nitrogen-protected mixing, vacuum degassing and filtration processes. The resulting contents have a viscosity adapted for softgel capsule filling, low moisture content and good oxidative stability, and can improve the storage stability of the finished product.
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Description

[0001] DESCRIPTION

[0002] High-Stability Soybean Lecithin Oily Softgel Capsule Contents and Preparation Method Thereof

[0003] Technical Field

[0004] The present invention relates to the technical field of food functional ingredients and softgel capsule preparations, and specifically relates to high-stability soybean lecithin oily softgel capsule contents and a preparation method thereof.

[0005] Background Art

[0006] Soybean lecithin is a natural phospholipid mixture extracted during soybean oil processing, mainly comprising phosphatidylcholine, phosphatidylethanolamine, phosphatidylinositol and other components, and is widely used as a nutritional supplement ingredient in the fields of foods and health foods. Fluid soybean lecithin has a relatively high viscosity at room temperature, and its molecular structure contains unsaturated fatty acid chains, which are susceptible to quality deterioration under the influence of oxygen, moisture, temperature and other factors. Therefore, it is usually made into a softgel capsule dosage form, in which the capsule shell isolates external light and oxygen, thereby improving administration convenience and product storage stability. For softgel capsule products, the rheological properties, moisture level, antioxidant capacity and compatibility with the gelatin capsule shell of the contents directly affect rotary-die encapsulation efficiency, drying process control and the shelf life of finished products, and are core issues that need to be comprehensively balanced in the development of lecithin softgel capsule formulas.

[0007] At present, common soybean lecithin softgel capsule contents mostly use ordinary vegetable oils such as soybean oil and corn oil as dilution carriers to adjust system viscosity, in combination with a single vitamin E component to delay oxidation, and some formulas also introduce water, ethanol or whiteDESCRIPTION

[0008] beeswax to adjust the state of the contents. Although such schemes can satisfy basic filling production requirements, obvious shortcomings remain in practical application. Ordinary vegetable oils mostly contain many unsaturated fatty acids and have limited oxidative resistance themselves; during long-term storage they are prone to rancidity and instead increase the oxidation risk of the overall oil phase. Additionally added water or ethanol changes the polarity state of the contents and can readily undergo moisture or small-molecule substance migration with the gelatin capsule shell during storage, causing capsule shell hardening, leakage and other problems. Waxy components such as white beeswax have poor compatibility with the phospholipid system and are prone to stratification and precipitation after prolonged standing, destroying the uniform state of the contents. In addition, most formulas lack strict control over moisture residues and oxygen contact during preparation, and it is difficult to ensure long-term storage stability of the finished product by relying only on the quality of the raw materials themselves.

[0009] Summary of the Invention

[0010] The purpose of the present invention is to make up for the deficiencies of the prior art by providing high- stability soybean lecithin oily softgel capsule contents and a preparation method thereof. The present invention optimizes the component ratio and preparation process of soybean lecithin softgel capsule contents, uses caprylic / capric triglyceride instead of traditional vegetable oil to adjust system viscosity, and compounds mixed tocopherols with L-ascorbyl palmitate to form a synergistic antioxidant effect, while adding no additional water, ethanol or white beeswax, thereby reducing the risk of component stratification and capsule shell leakage during storage. In the preparation stage, low-temperature vacuum dehydration, nitrogen-protected mixing, vacuum degassing and filtration are used toDESCRIPTION

[0011] control moisture residues and oxygen contact throughout the process, thereby reducing oxidative degradation of phospholipids during processing. The resulting contents have a viscosity suitable for continuous softgel encapsulation, low moisture content and good oxidative stability, and can effectively improve the storage stability of the finished product.

[0012] To solve the above technical problems, the present invention provides the following technical solution: in one aspect, high- stability soybean lecithin oily softgel capsule contents are provided, wherein the oily softgel capsule contents, calculated on the basis of 100% by total weight, consist of the following components:

[0013] fluid soybean lecithin 74.0% to 76.0%;

[0014] caprylic / capric triglyceride 23.5% to 25.5%;

[0015] mixed tocopherols 0.30% to 0.36%;

[0016] L-ascorbyl palmitate 0.12% to 0.16%;

[0017] the oily softgel capsule contents contain no additionally added water, ethanol, soybean oil, corn oil, fish oil, sunflower seed oil, perilla oil or white beeswax;

[0018] the oily softgel capsule contents are prepared by low-temperature vacuum dehydration, nitrogen-protected mixing, vacuum degassing and filtration.

[0019] Further, the oily softgel capsule contents, calculated on the basis of 100% by total weight, consist of: fluid soybean lecithin 75.00%; caprylic / capric triglyceride 24.52%; mixed tocopherols 0.34%; and L-ascorbyl palmitate 0.14%.

[0020] Further, the fluid soybean lecithin has an acetone-insoluble matter content of 58.0% to 65.0%, a phosphatidylcholine content of 12.0% to 20.0%, a moisture content of <=0.80%, and an initial peroxide value of <=3.0 mmol / kg.DESCRIPTION

[0021] Further, the total content of caprylic triglyceride and capric triglyceride in the caprylic / capric triglyceride is >=95.0%, the acid value is <=0.50 mg KOH / g, the iodine value is <=1.0 g 12 / 100 g, and the peroxide value is <=1.0 mmol / kg.

[0022] Further, the mass ratio of the mixed tocopherols to the L-ascorbyl palmitate is 2.1 to 2.7:1, and the combination of the two can improve the antioxidant capacity of the system through a synergistic effect of free-radical scavenging and component regeneration.

[0023] Further, the oily softgel capsule contents have a moisture content of <=0.30% as measured by the Karl Fischer method and a dynamic viscosity of 3500 mPa s to 5200 mPa s as measured at 40°C, and can be directly adapted to continuous softgel capsule rotary-die production.

[0024] Further, after the oily softgel capsule contents are sealed and subjected to accelerated storage at 40°C and 75% relative humidity for 30 days, the peroxide value is <=5.0 mmol / kg and the phosphatidylcholine retention rate is >=92.0%, corresponding to a low oil leakage risk of the finished softgel capsules.

[0025] In another aspect, a preparation method for high-stability soybean lecithin oily softgel capsule contents is provided, the preparation method comprising the following steps:

[0026] 51, heating caprylic / capric triglyceride to 50°C to 56°C, under nitrogen protection first adding L-ascorbyl palmitate and stirring until completely dissolved, then adding mixed tocopherols, and stirring for 10 to 20 minutes to obtain an antioxidant oil phase;

[0027] 52, treating fluid soybean lecithin at 42°C to 48°C under a vacuum degree of -0.085 MPa to -0.095 MPa for 20 to 40 minutes to obtain dehydrated fluid soybean lecithin;

[0028] 53, cooling the dehydrated fluid soybean lecithin obtained in step S2 toDESCRIPTION

[0029] 38°C to 44°C, slowly adding the antioxidant oil phase obtained in step SI under nitrogen protection, and stirring for 20 to 35 minutes to obtain a mixed oil phase;

[0030] 54, degassing the mixed oil phase obtained in step S3 at a vacuum degree of -0.080 MPa to -0.095 MPa for 10 to 20 minutes to remove tiny bubbles entrained in the material liquid and avoid pores in the capsules during rotary-die encapsulation;

[0031] 55, filtering the degassed mixed oil phase through an 80-mesh to 100-mesh filter to remove trace impurities and agglomerated particles, thereby obtaining the high- stability soybean lecithin oily softgel capsule contents.

[0032] Further, the dehydrated fluid soybean lecithin obtained in step S2 has a moisture content of <=0.30%.

[0033] Further, during the nitrogen protection process in step SI and step S3, the oxygen content in the headspace of the mixing tank is controlled below 5.0%; in step S3, the stirring speed is 60 r / min to 120 r / min, and the material temperature during mixing is controlled at 40°C to 43 °C, thereby reducing oxidative damage to phospholipid components caused by high temperature.

[0034] Compared with the prior art, the high-stability soybean lecithin oily softgel capsule contents and the preparation method thereof have the following beneficial effects:

[0035] I. The present invention adopts an oil phase system in which fluid soybean lecithin is compounded with caprylic / capric triglyceride, and combines it with an antioxidant combination composed of mixed tocopherols and L-ascorbyl palmitate, thereby adjusting the rheological properties of the contents while ensuring the proportion of soybean lecithin. Caprylic / capric triglyceride has good compatibility with phospholipid components, can adjustDESCRIPTION

[0036] the system viscosity to a suitable range for softgel capsule filling without a high addition amount, and has a high degree of saturation and strong oxidative stability, so that after replacing traditional vegetable oil, it can reduce the oxidation risk introduced by unsaturated oils. The combined action of the two antioxidant components can enhance the antioxidant capacity of the oil phase through a synergistic mechanism of free-radical scavenging and component regeneration. Meanwhile, the system contains no additionally added water, ethanol or white beeswax, which can reduce the possibility of moisture migration and component stratification during storage and lower the probability of oil leakage in softgel capsules.

[0037] II. Through the combination of low-temperature vacuum dehydration, nitrogen-protected mixing and vacuum degassing processes, the present invention controls the residual moisture and oxygen contact of the materials throughout the preparation process. Low-temperature vacuum dehydration can remove free water carried in the fluid soybean lecithin raw material, control the overall moisture of the system at a relatively low level, and reduce factors inducing phospholipid hydrolysis and capsule shell moisture migration. The mixing process under nitrogen protection can reduce the probability of contact between the materials and oxygen, and in combination with a relatively low processing temperature, can reduce oxidative degradation of phospholipids during preparation. The vacuum degassing and filtration processes can remove bubbles and trace impurities entrained in the material liquid, ensure the uniformity of the material liquid, adapt to continuous softgel capsule filling production, and help maintain the appearance stability of the finishedDESCRIPTION

[0038] product during storage.

[0039] Other advantages, objectives and features of the present invention will be set forth in part in the following description, and in part will be apparent to those skilled in the art based on examination and study of the following, or may be learned from the practice of the present invention.

[0040] Brief Description of the Drawings

[0041] To more clearly describe the embodiments of the present invention or the technical solutions in the prior art, the drawings required for the description of the embodiments or the prior art are briefly introduced below. Obviously, the drawings described below are merely some embodiments of the present invention, and those of ordinary skill in the art may obtain other drawings based on these drawings without creative effort.

[0042] Fig. 1 is a preparation flow chart of the high- stability soybean lecithin oily softgel capsule contents of the present invention;

[0043] Fig. 2 is a flow chart of the low-temperature vacuum dehydration process for fluid soybean lecithin according to the present invention;

[0044] Fig. 3 is a flow chart of the preparation of the antioxidant oil phase and the nitrogen-protected mixing process according to the present invention.

[0045] Specific Embodiments

[0046] The technical solutions of the present invention are further described below through specific tests. Unless otherwise specified, the raw materials used in the following tests are all food-grade commercially available products, and the operating methods used are conventional operations in the art unless otherwise specified.

[0047] The test raw materials and detection methods are as follows.

[0048] Test raw materials:

[0049] Fluid soybean lecithin: acetone-insoluble matter content 62.1%,DESCRIPTION

[0050] phosphatidylcholine content 15.4%, moisture content 0.62%, and initial peroxide value 2.2 mmol / kg;

[0051] Caprylic / capric triglyceride: total content of caprylic triglyceride and capric triglyceride 97.3%, acid value 0.18 mg KOH / g, iodine value 0.4 g 12 / 100 g, and peroxide value 0.3 mmol / kg;

[0052] Mixed tocopherols: total tocopherol content 70.2%;

[0053] L-ascorbyl palmitate: food grade, meeting the requirements for use as a food additive;

[0054] Refined soybean oil: food grade I, acid value 0.15 mg KOH / g and peroxide value 0.4 mmol / kg.

[0055] Detection methods:

[0056] Moisture content: determined by the Karl Fischer volumetric method. Before determination, the sample was thoroughly mixed at 40°C, and the average of three parallel determinations was taken.

[0057] Dynamic viscosity: determined by a rotational viscometer. The sample was equilibrated at 40°C + / - 0.5 °C for 20 min before determination, and the result was expressed in mPa s.

[0058] Peroxide value: determined by the iodine titration method for edible oils and fats, with the result expressed in mmol / kg.

[0059] Phosphatidylcholine content: determined by high-performance liquid chromatography, using a normal-phase silica gel chromatographic column for separation, an n-hexane-isopropanol-water system as the mobile phase, evaporative light scattering detection, and external- standard quantification.

[0060] Phosphatidylcholine retention rate: calculated as the ratio of the phosphatidylcholine content after the accelerated storage test to the initial phosphatidylcholine content, expressed as a percentage.

[0061] Softgel capsule oil leakage rate: The contents of each group were prepared into softgel capsules with a fill weight of 750 mg per capsule usingDESCRIPTION

[0062] the same shell formula and rotary-die encapsulation process. For each group, 1000 capsules were taken, placed at 40°C and 75% relative humidity for 30 days, and the number of softgel capsules with obvious oil leakage traces was counted to calculate the oil leakage rate. The softgel capsule shell was prepared from gelatin, glycerol, sorbitol solution and purified water at a mass ratio of 100:38:12:90. After rotary-die encapsulation, the capsules were first dried for 24 h at 20°C to 25°C and 25% to 35% relative humidity, and then equilibrated for 48 h at 22°C to 28°C and 35% to 45% relative humidity.

[0063] Accelerated storage test: The prepared softgel capsules were sealed and placed in a constant-temperature and constant-humidity chamber at 40°C and 75% relative humidity for 30 consecutive days. Upon completion, samples were taken to determine the peroxide value and phosphatidylcholine content of the contents.

[0064] Example 1

[0065] In this example, high-stability soybean lecithin oily softgel capsule contents were prepared, with a total charge amount of 1000.0 g. The raw material composition was: fluid soybean lecithin 750.0 g, caprylic / capric triglyceride 245.2 g, mixed tocopherols 3.4 g, and L-ascorbyl palmitate 1.4 g.

[0066] The complete preparation process of this example is shown in Fig. 1, and the specific operations of each process are as follows:

[0067] SI, preparation of antioxidant oil phase: The flow of this step and the subsequent nitrogen-protected mixing process is shown in Fig. 3. Caprylic / capric triglyceride was charged into a clean mixing tank and heated to 52°C; nitrogen was introduced into the tank to replace the air in the headspace, and continuous nitrogen introduction was maintained to keep the oxygen content in the tank below 5.0%. L-ascorbyl palmitate was first added and stirred for 12 minutes until the material was completely dissolved, then mixed tocopherols were added, and stirring was continued for 5 minutes untilDESCRIPTION

[0068] the system was uniform, thereby obtaining an antioxidant oil phase.

[0069] 52, low-temperature vacuum dehydration of fluid soybean lecithin: The process flow of this step is shown in Fig. 2. Fluid soybean lecithin was charged into a vacuum mixing tank, slowly heated to 45 °C, and the vacuum system was started. The vacuum degree in the tank was controlled at -0.090 MPa, and dehydration was carried out with heat preservation for 30 minutes under these conditions. After treatment, sampling and testing were performed, and the moisture content of the dehydrated soybean lecithin was 0.28%.

[0070] 53, mixing under nitrogen protection: The dehydrated soybean lecithin was cooled to 42°C, nitrogen was continuously introduced to maintain the oxygen content in the tank at <=5.0%, and the antioxidant oil phase described above was slowly added. The stirring speed was controlled at 90 r / min, and stirring was continued for 30 minutes. During mixing, the material temperature was maintained at 41 °C to 42°C, and after the system became uniform and transparent, a mixed oil phase was obtained.

[0071] 54, vacuum degassing: The mixed oil phase was maintained at about 41 °C, the vacuum degree was controlled at -0.085 MPa, and degassing was performed for 15 minutes to remove tiny bubbles entrained during mixing.

[0072] 55, filtration and discharge: The degassed mixed oil phase was filtered through a 100-mesh screen to remove trace impurities, thereby obtaining the finished contents.

[0073] Example 2

[0074] In this example, high-stability soybean lecithin oily softgel capsule contents were prepared, with a total charge amount of 1000.0 g. The raw material composition was: fluid soybean lecithin 750.1 g, caprylic / capric triglyceride 245.0 g, mixed tocopherols 3.5 g, and L-ascorbyl palmitate 1.4 g.

[0075] The preparation steps were as follows:

[0076] SI, preparation of antioxidant oil phase: Caprylic / capric triglyceride wasDESCRIPTION

[0077] charged into a mixing tank, heated to 50°C, nitrogen was introduced to replace the air in the tank and maintain the oxygen content below 5.0%, L-ascorbyl palmitate and mixed tocopherols were added at one time, and continuous stirring was performed for 18 minutes until the materials were completely dissolved and dispersed, thereby obtaining an antioxidant oil phase.

[0078] 52, low-temperature vacuum dehydration of fluid soybean lecithin: Fluid soybean lecithin was charged into a vacuum mixing tank, heated to 44 °C, and the vacuum degree was controlled at -0.088 MPa. Dehydration was carried out with heat preservation for 35 minutes; sampling and testing showed that the moisture content of the dehydrated soybean lecithin was 0.29%.

[0079] 53, mixing under nitrogen protection: The dehydrated soybean lecithin was cooled to 41 °C, the antioxidant oil phase was added under nitrogen protection, the stirring speed was controlled at 80 r / min, and stirring was continued for 32 minutes. During mixing, the material temperature was maintained at 40°C to 42°C, thereby obtaining a uniform mixed oil phase.

[0080] 54, vacuum degassing: The mixed oil phase was degassed for 18 minutes at a vacuum degree of -0.085 MPa.

[0081] 55, filtration and discharge: The degassed material was filtered through a 100-mesh screen to obtain the finished product.

[0082] Example 3

[0083] In this example, high-stability soybean lecithin oily softgel capsule contents were prepared, with a total charge amount of 1000.0 g. The raw material composition was: fluid soybean lecithin 760.0 g, caprylic / capric triglyceride 235.5 g, mixed tocopherols 3.1 g, and L-ascorbyl palmitate 1.4 g.

[0084] The preparation steps were as follows:

[0085] SI, preparation of antioxidant oil phase: Caprylic / capric triglyceride was heated to 55 °C, and L-ascorbyl palmitate and mixed tocopherols were addedDESCRIPTION

[0086] under nitrogen protection and stirred for 15 minutes until dissolved and mixed uniformly, thereby obtaining an antioxidant oil phase. During nitrogen protection, the oxygen content in the headspace of the mixing tank was controlled below 5.0%.

[0087] 52, low-temperature vacuum dehydration of fluid soybean lecithin: Fluid soybean lecithin was heated to 46°C and dehydrated for 25 minutes under a vacuum degree of -0.092 MPa. Sampling and testing showed that the moisture content of the dehydrated soybean lecithin was 0.29%.

[0088] 53, mixing under nitrogen protection: The dehydrated soybean lecithin was cooled to 43 °C, the antioxidant oil phase was added under nitrogen protection, the stirring speed was controlled at 100 r / min, and stirring was continued for 25 minutes. During mixing, the material temperature was maintained at 41 °C to 43 °C, thereby obtaining a mixed oil phase.

[0089] 54, vacuum degassing: The mixed oil phase was degassed for 12 minutes at a vacuum degree of -0.090 MPa.

[0090] 55, filtration and discharge: The degassed material was filtered through an 80-mesh screen to obtain the finished product.

[0091] Comparative Example 1

[0092] This comparative example directly used fluid soybean lecithin as softgel capsule contents, without adding any other component and without carrying out low-temperature vacuum dehydration, nitrogen-protected mixing or vacuum degassing treatment, and the sample was directly tested and prepared into softgel capsules.

[0093] Comparative Example 2

[0094] In this comparative example, the total raw material mass was the same as in Example 1, and the preparation process was completely the same as in Example 1, except that caprylic / capric triglyceride was replaced with an equal mass of refined soybean oil.DESCRIPTION

[0095] The raw material composition was: fluid soybean lecithin 750.0 g, refined soybean oil 245.2 g, mixed tocopherols 3.4 g, and L-ascorbyl palmitate 1.4 g.

[0096] Comparative Example 3

[0097] In this comparative example, the total raw material mass was the same as in Example 1, and the preparation process was completely the same as in Example 1, except that mixed tocopherols and L-ascorbyl palmitate were not added, and the amounts of the two omitted components were made up by an equal mass of caprylic / capric triglyceride.

[0098] The raw material composition was: fluid soybean lecithin 750.0 g and caprylic / capric triglyceride 250.0 g.

[0099] Comparative Example 4

[0100] In this comparative example, the total raw material mass was the same as in Example 1, and the preparation process was completely the same as in Example 1, except that L-ascorbyl palmitate was not added, and the amount of the omitted component was made up by an equal mass of caprylic / capric triglyceride.

[0101] The raw material composition was: fluid soybean lecithin 750.0 g, caprylic / capric triglyceride 246.6 g, and mixed tocopherols 3.4 g.

[0102] Comparative Example 5

[0103] The raw material composition of this comparative example was completely the same as that of Example 1, except that the preparation process was adjusted as follows: the fluid soybean lecithin was not subjected to low-temperature vacuum dehydration, nitrogen protection was not introduced during mixing, and the mixing temperature was increased to 60°C, while the filtration step remained the same as in Example 1.

[0104] Comparative Example 6

[0105] In this comparative example, the total raw material mass was the same asDESCRIPTION

[0106] in Example 1, and the preparation process was basically performed with reference to Example 1, except that a 30% ethanol-water solution in an amount of 1.0% by mass was additionally added to the formula, and the amount of caprylic / capric triglyceride was reduced by an equal amount. The ethanol-water solution was added during the mixing stage.

[0107] The raw material composition was: fluid soybean lecithin 750.0 g, caprylic / capric triglyceride 235.2 g, 30% ethanol-water solution 10.0 g, mixed tocopherols 3.4 g, and L-ascorbyl palmitate 1.4 g.

[0108] Test Results and Analysis

[0109] The samples prepared in Examples 1 to 3 and Comparative Examples 1 to 6 above were tested for various indicators according to the detection methods described above, and were prepared into softgel capsules for accelerated storage tests. The test results are shown in the following table.

[0110] Viscosity at Initial PV / PV after 30 d / PC retention

[0111] Sample Moisture / % Oil leakage / %

[0112] 40°C / mPa-s mmol / kg mmol / kg / %

[0113] Ex. 1 0.23 4050 2.0 3.5 96.4 0.8 Ex. 2 0.24 3750 2.1 3.7 95.8 0.9 Ex. 3 0.25 4550 2.1 3.9 95.5 1.0 Comp. Ex. 1 0.62 9100 2.4 6.8 89.7 3.8 Comp. Ex. 2 0.24 4850 2.2 5.4 92.1 1.5 Comp. Ex. 3 0.24 3980 2.2 5.8 90.8 1.0 Comp. Ex. 4 0.23 4050 2.1 4.8 92.9 0.9 Comp. Ex. 5 0.54 4240 2.8 5.1 91.8 2.6 Comp. Ex. 6 0.78 4620 2.6 5.0 92.4 2.3

[0114]

[0115] From the results of Examples 1 to 3, it can be seen that the oily contents prepared using the formula and process of the present invention have low moisture content, a 40°C dynamic viscosity suitable for softgel capsule filling requirements, and a low initial peroxide value. After accelerated storage for 30 days, the increase in peroxide value is small, the phosphatidylcholine retention is good, the corresponding softgel capsule oil leakage rate is low,DESCRIPTION

[0116] and all indicators show stable performance.

[0117] Compared with Example 1, Comparative Example 1 directly used untreated fluid soybean lecithin, resulting in a significantly higher viscosity that is difficult to use directly for softgel capsule filling. In addition, the moisture content was high and there was no antioxidant protection; after accelerated storage, oxidation was more severe, active component loss was greater, and the softgel capsule oil leakage rate was higher, indicating that a single fluid soybean lecithin cannot be directly used as stable softgel capsule contents.

[0118] From the results of Comparative Example 2, after refined soybean oil replaced caprylic / capric triglyceride, the viscosity could be adjusted to a certain extent, but soybean oil itself had a high degree of unsaturation. After accelerated storage, the peroxide value increased significantly, the phosphatidylcholine retention rate decreased, and the softgel capsule oil leakage rate also increased, indicating that caprylic / capric triglyceride can both adjust viscosity in this system and better maintain the oxidative stability of the oil phase.

[0119] Comparing the results of Comparative Examples 3 and 4 with Example 1, when no antioxidant was added, the oxidation degree of the system after accelerated storage was significantly deepened, and the active component retention rate decreased. When only mixed tocopherols were added, the antioxidant effect was weaker than that of the two antioxidants used in combination, indicating that the combined use of mixed tocopherols and L-ascorbyl palmitate can more effectively delay phospholipid oxidation.

[0120] Comparative Example 5 omitted the low-temperature vacuum dehydration and nitrogen protection processes and simultaneously increased the mixing temperature. As a result, the initial moisture content and peroxide value of the final contents both increased, the stability after acceleratedDESCRIPTION

[0121] storage decreased, and the softgel capsule oil leakage rate increased significantly, indicating that the combination of low-temperature dehydration and nitrogen protection has a direct effect on controlling the initial quality of the product and improving storage stability.

[0122] Comparative Example 6 introduced an ethanol-water solution into the system, causing the moisture content of the contents to increase greatly, and the oil leakage rate of the softgel capsules after accelerated storage increased significantly. This indicates that not additionally adding water and ethanol is more conducive to maintaining the stability of the softgel capsule shell and reducing leakage problems.

[0123] In summary, through the mutual cooperation of component ratios and preparation processes, the present invention can obtain soybean lecithin oily softgel capsule contents with suitable viscosity, low moisture content and good oxidative stability, and can solve practical problems of existing similar products such as unsuitable viscosity, insufficient oxidative stability and poor compatibility with the capsule shell.

[0124] The foregoing are merely preferred embodiments of the present invention and do not limit the present invention in any form. Although the present invention has been disclosed above by way of preferred embodiments, they are not intended to limit the present invention. Any person skilled in the art may make some changes or modifications to the technical content disclosed above as equivalent embodiments without departing from the scope of the technical solution of the present invention. Any simple modifications, equivalent changes and modifications made to the above embodiments according to the technical essence of the present invention without departing from the content of the technical solution of the present invention shall still fall within the scope of the technical solution of the present invention.

Claims

CLAIMS1. A high-stability soybean lecithin oily softgel capsule contents, characterized in that the oily softgel capsule contents, calculated on the basis of 100% by total weight, consist of the following components:fluid soybean lecithin 74.0% to 76.0%;caprylic / capric triglyceride 23.5% to 25.5%;mixed tocopherols 0.30% to 0.36%;L-ascorbyl palmitate 0.12% to 0.16%;the oily softgel capsule contents contain no additionally added water, ethanol, soybean oil, corn oil, fish oil, sunflower seed oil, perilla oil or white beeswax;the oily softgel capsule contents are prepared by low-temperature vacuum dehydration, nitrogen-protected mixing, vacuum degassing and filtration.

2. The high-stability soybean lecithin oily softgel capsule contents according to claim 1, characterized in that the oily softgel capsule contents, calculated on the basis of 100% by total weight, consist of: fluid soybean lecithin 75.00%; caprylic / capric triglyceride 24.52%; mixed tocopherols 0.34%; and L-ascorbyl palmitate 0.14%.

3. The high-stability soybean lecithin oily softgel capsule contents according to claim 1, characterized in that the fluid soybean lecithin has an acetone-insoluble matter content of 58.0% to 65.0%, a phosphatidylcholine content of 12.0% to 20.0%, a moisture content of <=0.80%, and an initial peroxide value of <=3.0 mmol / kg.

4. The high-stability soybean lecithin oily softgel capsule contents according to claim 1, characterized in that the total content of caprylic triglyceride and capric triglyceride in the caprylic / capric triglyceride is >=95.0%, the acid value is <=0.50 mg KOH / g, the iodine value is <=1.0 g 12 / 100 g, and the peroxide value is <=1.0 mmol / kg.

5. The high-stability soybean lecithin oily softgel capsule contentsCLAIMSaccording to claim 1, characterized in that the mass ratio of the mixed tocopherols to the L-ascorbyl palmitate is 2.1 to 2.7:1.

6. The high-stability soybean lecithin oily softgel capsule contents according to claim 1, characterized in that the oily softgel capsule contents have a moisture content of <=0.30% as measured by the Karl Fischer method and a dynamic viscosity of 3500 mPa s to 5200 mPa s as measured at 40°C.

7. The high-stability soybean lecithin oily softgel capsule contents according to claim 1, characterized in that, after sealing and accelerated storage at 40°C and 75% relative humidity for 30 days, the oily softgel capsule contents have a peroxide value of <=5.0 mmol / kg and a phosphatidylcholine retention rate of >=92.0%.

8. A preparation method for high- stability soybean lecithin oily softgel capsule contents, the method being used to prepare the high- stability soybean lecithin oily softgel capsule contents according to any one of claims 1 to 7, characterized in that the preparation method comprises the following steps:51, heating caprylic / capric triglyceride to 50°C to 56°C, adding L-ascorbyl palmitate and mixed tocopherols under nitrogen protection, and stirring for 10 to 20 minutes to obtain an antioxidant oil phase;52, treating fluid soybean lecithin at 42°C to 48°C under a vacuum degree of -0.085 MPa to -0.095 MPa for 20 to 40 minutes to obtain dehydrated fluid soybean lecithin;53, cooling the dehydrated fluid soybean lecithin obtained in step S2 to 38°C to 44°C, adding the antioxidant oil phase obtained in step SI under nitrogen protection, and stirring for 20 to 35 minutes to obtain a mixed oil phase;54, degassing the mixed oil phase obtained in step S3 at a vacuum degree of -0.080 MPa to -0.095 MPa for 10 to 20 minutes;55, filtering the degassed mixed oil phase through an 80-mesh toCLAIMS100-mesh filter to obtain the high-stability soybean lecithin oily softgel capsule contents.

9. The preparation method for high- stability soybean lecithin oily softgel capsule contents according to claim 8, characterized in that the dehydrated fluid soybean lecithin obtained in step S2 has a moisture content of <=0.30%.

10. The preparation method for high- stability soybean lecithin oily softgel capsule contents according to claim 8, characterized in that during the nitrogen protection process in step SI and step S3, the oxygen content in the headspace of the mixing tank is controlled below 5.0%; in step S3, the stirring speed is 60 r / min to 120 r / min, and the material temperature during mixing is controlled at 40°C to 43°C.