Coenzyme Q10 soft capsule and preparation method thereof

Abstract

The invention relates to a coenzyme Q10 soft capsule and a preparation method thereof, and belongs to the technical field of health care products. The problems that an existing product wall material is insufficient in compactness and poor in stability, and contents are prone to seeping out are solved. The soft capsule is composed of a content and a wall material according to a specific mass ratio, the content contains coenzyme Q10, soybean oil, vitamin E and phospholipid, and the wall material contains gelatin, glycerin, an aloe-tremella mixed extract and purified water. The aloe-tremella mixed extract is prepared through pretreatment of fresh aloe, preparation of tremella powder, construction of a mixed system, ultrasonic extraction and post-treatment, natural active mucopolysaccharide and tremella polysaccharide contained in the aloe-tremella mixed extract can be synergistically crosslinked, and the aloe-tremella mixed extract, gelatin and glycerin jointly construct a compact wall material structure. The preparation method is simple in process, easy in parameter control and free of special equipment, the product can improve illumination and oxidation stability and reduce the content exudation rate, physicochemical properties and use safety are both considered, and the preparation method is suitable for industrial production.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of health products, and relates to a coenzyme Q10 soft capsule and a preparation method thereof. BACKGROUND

[0002] Coenzyme Q10 is a key substance in the respiratory chain of human cell mitochondria, has multiple physiological functions such as participating in energy metabolism, scavenging free radicals, antioxidation, protecting the cardiovascular system, enhancing immunity, and has been widely used in the field of health products. Coenzyme Q10 soft capsules become one of the most mainstream coenzyme Q10 health product dosage forms on the market at present due to the advantages of convenient taking, high bioavailability, and effective protection of active ingredients from external environment.

[0003] Coenzyme Q10 itself is a fat-soluble substance, contains multiple unsaturated bonds in the molecular structure, and is easy to be oxidatively degraded under the conditions of light, oxygen and high temperature, resulting in loss of active ingredients and decline of product efficacy; at the same time, the wall material of the coenzyme Q10 soft capsule serves as the core protection barrier of the content, and its compactness and stability directly determine the storage period, active ingredient retention rate and use safety of the product.

[0004] However, the existing coenzyme Q10 soft capsule wall material has the technical defects of insufficient compactness, large intermolecular gap, weak anti-aging ability and poor light stability, and it is difficult to meet the stability requirements of high-quality products, and it is urgent to develop a new wall material system that can effectively improve the storage stability and light stability while ensuring the qualified physicochemical properties (such as suitable disintegration time) of the product, reduce the content leakage rate and oxidation risk, and has a simple preparation method, controllable cost and is suitable for industrial production. SUMMARY

[0005] The purpose of the present application is to overcome the technical defects of insufficient compactness, poor stability and easy leakage of the content of the existing coenzyme Q10 soft capsule wall material, and to provide a coenzyme Q10 soft capsule and a preparation method thereof.

[0006] The present application uses fresh aloe mucilage and dried tremella powder as raw materials, grinds the dried tremella into powder, then adds fresh aloe mucilage to form a mixed system, and prepares a mixed extract after optimizing the extraction process; the natural active mucopolysaccharide in fresh aloe mucilage and tremella polysaccharide in tremella powder form a synergistic crosslinking effect, together with gelatin and glycerol to construct a compact wall material network structure, achieving the technical effects of "low leakage rate and high oxidation resistance".

[0007] The purpose of the present application can be achieved by the following technical solutions:

[0008] A coenzyme Q10 soft capsule, which is composed of content and wall material in a mass ratio of 1:0.9-1.3.

[0009] As a preferred technical solution of the present application, the content is composed of the following components by mass fraction: coenzyme Q10 105-15 parts, soybean oil 70-85 parts, vitamin E 1-4 parts, phospholipid 1-2 parts.

[0010] As a preferred technical solution of the present application, the wall material is composed of the following components by mass fraction: gelatin 28-36 parts, glycerol 13-19 parts, aloe-silver fungus mixed extract 6-13 parts, purified water 38-46 parts.

[0011] As a preferred technical solution of the present application, the preparation method of the aloe-silver fungus mixed extract comprises the following steps:

[0012] W1. Fresh aloe pretreatment: take fresh aloe leaves, wash and peel to take gelatinous pulp, grind to paste with colloid mill, filter with 100 mesh filter cloth, and collect fresh aloe mucilage;

[0013] W2. Silver fungus powder preparation: take dried silver fungus and grind to 80-120 mesh powder;

[0014] W3. Mixed system construction: according to the mass ratio of fresh aloe mucilage to silver fungus powder 1.2-2.0:1, add silver fungus powder to fresh aloe mucilage, stir at 150-200 rpm for 15-20 min to form mixed slurry;

[0015] W4. Ultrasonic extraction: add purified water to the mixed slurry, and the total mass of fresh aloe mucilage and purified water is 9-13 times the mass of silver fungus powder, ultrasonic extraction under the conditions of ultrasonic power 350-550 W, extraction temperature 55-75 ℃, and extraction time 35-65 min;

[0016] W5. Post-treatment: filter the extract liquid with 100 mesh filter cloth, and concentrate the filtrate under reduced pressure to a solid content of 22-32% at 62-72 ℃ and a vacuum degree of -0.09~-0.07 MPa.

[0017] As a preferred technical solution of the present application, the content is composed of the following components by mass fraction: coenzyme Q10 105-15 parts, soybean oil 70-85 parts, vitamin E 1-4 parts, phospholipid 1-2 parts.

[0018] As a preferred technical solution of the present application, the wall material is composed of the following components by mass fraction: gelatin 28-36 parts, glycerol 13-19 parts, aloe-silver fungus mixed extract 6-13 parts, purified water 38-46 parts.

[0019] As a preferred technical solution of the present application, the mass ratio of fresh aloe mucilage to silver fungus powder is 1.5:1.

[0020] A preparation method of the coenzyme Q10 soft capsule as described above comprises the following steps:

[0021] X1. Add coenzyme Q10, soybean oil, vitamin E and phospholipid into a stirring tank, and mix uniformly under constant temperature stirring;

[0022] X2. Add gelatin, glycerol and purified water into a dissolving tank, and stir at 52-62℃ for 32-42 min until the gelatin is completely dissolved, then add the aloe-silver fungus mixed extract, continue to stir at 220-320 rpm for 22-32 min, and keep the temperature at 46-51℃;

[0023] X3. Input the content and wall material liquid into a soft capsule pill press, and press into shape under the conditions of a pill pressing temperature of 26-31℃, a roller speed of 2.5-4.5 r / min, and a rubber thickness of 0.9-1.3 mm;

[0024] X4. Dry under the conditions of a temperature of 21-26℃ and a relative humidity of 42-52% for 13-17 h, and obtain the product.

[0025] As a preferred technical solution of the present application, the constant temperature stirring in step X1 refers to stirring at a speed of 350-550 rpm for 18-23 min under the condition of 32-42℃.

[0026] As a preferred technical solution of the present application, the drying in step X4 refers to drying under the conditions of a temperature of 26-32℃ and an air speed of 1.2-2.2 m / s for 9-13 h.

[0027] As a preferred technical solution of the present application,

[0028] The present application has the following advantages:

[0029] (1) The present application uses fresh aloe mucilage and silver fungus powder to prepare a mixed extract, the fresh aloe mucilage contains natural active mucopolysaccharide with complete structure and strong synergy, and forms a high-efficiency cross-linking effect with the silver fungus polysaccharide in the silver fungus powder, and together with the gelatin and glycerol, forms a dense wall material structure, which significantly improves the light stability and oxidation stability of the coenzyme Q10 soft capsule and reduces the content leakage rate, solving the problems of insufficient activity of the dried raw material extract and poor modification effect of single component in the prior art.

[0030] (2) The preparation process of the aloe-silver fungus mixed extract is optimized in a targeted manner, the silver fungus is first ground into powder and then mixed with fresh aloe mucilage to ensure that the two are fully dispersed, and the subsequent ultrasonic extraction conditions are mild, which can maximize the retention of mucopolysaccharide activity; at the same time, the fresh aloe raw material has a wide source and low cost, and has good compatibility with gelatin and glycerol, which will not cause the wall material to be too hard or delayed disintegration, and can balance the physical and chemical properties of the product and the use safety.

[0031] (3) The preparation method of the coenzyme Q10 soft capsule of the scheme has simple process, easy-to-control parameters, does not need special equipment, the processing technology of fresh aloe mucilage can be adapted to industrial production line, the product has high qualified rate, long shelf life, and has good market application prospect. DETAILED DESCRIPTION

[0032] In order to further illustrate the technical means and effects adopted by the present application to achieve the predetermined object of the application, the specific embodiments, structures, features and effects according to the present application are described in detail as follows in combination with examples.

[0033] The specific sources of the components are as follows

[0034] Fresh aloe vera: Baotong nursery in Yanyang County, Yancheng

[0035] Dried tremella fuciformis: Fujian Kangwang Food Co., Ltd.

[0036] Dried poria cocos: Hubei Dasyanzhibao Agricultural Products Development Co., Ltd.

[0037] Dried Chinese yam: Qinyang City Zhongdehai Pharmaceutical Co., Ltd.

[0038] Dried Astragalus membranaceus: Bozhou Jinbo Pharmaceutical Co., Ltd.

[0039] Dried Ophiopogon japonicus: Bozhou Fushanyuan Pharmaceutical Co., Ltd.

[0040] Dried medlar: Ningxia Juhuatai Manor Medlar Planting Co., Ltd.

[0041] Gelatin: Guangzhou Huaxi Biological Engineering Co., Ltd., item number 101

[0042] Coenzyme Q10: Shaanxi Ge Run Biological Technology Co., Ltd.

[0043] Soybean oil: Shijiazhuang Xuyi Grain and Oil Co., Ltd.

[0044] Vitamin E: Guangzhou Huaxi Biological Engineering Co., Ltd., item number 1011

[0045] Phospholipid: Guangzhou Jinmanyuan Biological Technology Co., Ltd., item number 042

[0046] Example 1

[0047] (1) Preparation of aloe vera-tremella fuciformis mixed extract

[0048] 1. Fresh aloe pretreatment: Take fresh aloe leaves 50.0 kg, rinse the surface 3 times with flowing purified water to remove dirt and impurities; remove the outer skin of the aloe leaves with a stainless steel knife, and take about 32.0 kg of internal gel-like pulp; put the pulp into a colloid mill, set the grinding gap to 0.05 mm, and grind twice to a fine paste; filter the paste with a 100-mesh filter cloth, collect the filtrate (fresh aloe mucilage) about 28.5 kg, and the residue (coarse fiber) about 3.5 kg, discard the residue;

[0049] 2. Preparation of tremella powder: Take dried tremella 9.6 kg, put it into a super micro grinder, set the grinding cavity cooling water temperature to 16℃, the grinding speed to 3200r / min, grind for 6 min, stop for 2 min, repeat 2 times; transfer the ground material to a 100-mesh standard sieve, use a vibrating sieve machine (amplitude 3.2 mm, frequency 52 Hz) to sieve, collect the undersize powder (tremella powder) about 9.2 kg, and the oversize particles about 0.4 kg, return to the grinder for regrinding until all is passed;

[0050] 3. Construction of mixed system: Slowly add 9.2 kg of tremella powder to 28.5 kg of fresh aloe mucilage, put it into a stirring tank, set the stirring speed to 180 rpm, stir for 18 min, observe that the mixed slurry has no obvious particles, is uniformly dispersed, and has no stratification phenomenon;

[0051] 4. Ultrasonic extraction: Add 66.1 kg of purified water to the mixed slurry, transfer it to an 80L stainless steel ultrasonic extraction tank, start stirring at a speed of 160r / min for 12 min to make the system uniform; start the ultrasonic extractor, set the ultrasonic power to 450W, the ultrasonic frequency to 26kHz, the jacketed constant temperature water bath temperature to 65℃, and the extraction time to 50 min; during the extraction process, take 10mL of the extract at 20min, 40min and 50min respectively, observe the clarity, and there are no obvious particles suspended, the extraction is completed;

[0052] 5. Post-processing: close the ultrasonic and stirring, about 103.8 L of the extract was transferred to a plate and frame filter, filter cloth was 100 mesh defatted cotton filter cloth, in advance with purified water wet, open air compressor, pressure 0.35 MPa to promote filtration, collected about 98.5 L filtrate; the filtrate was washed with 18.4 kg of purified water in 2 times, each time after washing, stirring 12 min, then filtration, collected about 34.2 L washing liquid, the filtrate and washing liquid were combined, about 132.7 L in total; the combined liquid was transferred to a rotary evaporator (evaporation area 0.15 m²), the evaporation temperature was set to 68°C, the vacuum degree was set to -0.08 MPa, and the rotation rate was set to 85 r / min, and continuous concentration was carried out; every 30 min, 2 g of the concentrated liquid was taken and the solid content was detected by the constant weight method at 105°C; when the solid content was 28%, the concentration was stopped, and about 22.5 kg of viscous aloe-silver fungus mixed extract was obtained, which was quickly transferred to a clean polyethylene barrel and stored at 4°C after sealing.

[0053] (2) Content preparation

[0054] 1. Weigh coenzyme Q10 10.0 kg, soybean oil 78.0 kg, vitamin E 2.5 kg, and phospholipid 1.5 kg, and add them to a 80 L stainless steel stirring tank in sequence;

[0055] 2. Close the stirring tank cover, open the jacket heating, set the temperature to 38°C, and at the same time open the stirring, the speed is 450 rpm, constant temperature stirring for 20 min;

[0056] 3. After stirring, 10 mL of the mixed liquid was taken with a pipette and placed in a glass test tube, and the solution was observed to be uniform, transparent, and free of stratification or flocculation, which was qualified content; the stirring tank temperature was maintained at 38°C for standby.

[0057] (3) Wall material preparation

[0058] 1. Weigh gelatin 32.0 kg (previously pulverized into 10 mesh particles), glycerol 16.0 kg, and purified water 42.0 kg, and add them to a 120 L jacketed dissolving tank in sequence;

[0059] 2. Open the jacket heating, set the temperature to 58°C, and at the same time open the stirring, the speed is 280 rpm, constant temperature stirring for 38 min; during the period, 10 mL of solution was taken at 15 min, 25 min, and 38 min, respectively, and at 38 min, the solution was free of visible particles and the gelatin was completely dissolved;

[0060] 3. Weigh aloe-silver fungus mixed extract 9.0 kg (previously taken out from 4°C refrigeration, restored to room temperature 25°C, and used within 1 h after taking out), and add it to the dissolving tank, continue stirring at a speed of 280 rpm for 28 min;

[0061] 4. The wall material liquid viscosity was detected by a rotary viscometer (25℃, rotor speed 10 rpm), and the detection value was 7300 mPa·s; the temperature of the dissolution tank was maintained at 49℃ (jacket heating), and it was ready for use.

[0062] (4) Pill forming

[0063] 1. The content was delivered to the content storage tank of the soft capsule pill press machine through a sanitary stainless steel pipeline (diameter 50 mm with a heat preservation layer), and the storage tank jacket was heated to maintain 38℃; the wall material liquid was delivered to the wall material liquid storage tank through another sanitary pipeline, and the storage tank jacket was heated to maintain 49℃;

[0064] 2. The parameters of the pill press were set as follows: roller temperature 29℃, roller speed 3.5 r / min, rubber thickness 1.1 mm, capsule size 0.6 g / particle (0.3 g of content and 0.3 g of wall material per particle);

[0065] 3. The pill press was started, and 100 particles were produced for trial, and after being taken out, the appearance was checked: the capsule surface was smooth, without spots, deformation, and the interface was flat; 10 capsules were weighed by an electronic balance, and the weight range was 0.558~0.642 g, and after passing the quality inspection, formal production was carried out;

[0066] 4. During the formal production process, 10 particles were sampled every 30 min, and the appearance and weight difference were checked, and the production was continued for about 10 h (if the content or wall material was consumed during the formal production process, the material would be continuously supplemented, and it was not limited to using the content or wall material prepared above, the same below), and about 20 million initially formed soft capsules were obtained.

[0067] (5) Drying and shaping

[0068] 1. The initially formed soft capsules were evenly placed on a stainless steel mesh tray with a size of 60 cm×40 cm and a mesh tray bottom covered with gauze, and the thickness of each tray was not more than 2 cm, and then the tray was placed into the shaping machine;

[0069] 2. The parameters of the shaping machine were set as follows: temperature 24℃, relative humidity 48%, conveying speed 0.6 m / min, and shaping for 15 h; after the shaping was completed, the capsules were taken out, and the hand feeling was not sticky, and the preliminary solidification was completed;

[0070] 3. The shaped soft capsules were transferred to a hot air circulating dryer, and the drying temperature was set to 30℃, and the air speed was 1.8 m / s, and the drying time was 11 h; during the period, 2 g of capsules were taken out every 2 h, and the moisture content was detected by the constant weight method at 105℃, and the moisture content at 11 h was 10.3%;

[0071] 4. The dryer was turned off, and the capsules were cooled to room temperature (25℃), and the unqualified products such as deformation, rupture, and weight out-of-tolerance were removed by manual screening, and about 19.1 million particles of finished coenzyme Q10 soft capsules were obtained, and the qualified rate was about 95.5%.

[0072] Example 2

[0073] (1) Preparation of Aloe-tremella mixed extract

[0074] 1. Fresh aloe pretreatment: Take 40.0 kg of fresh aloe leaves, wash and peel to take about 25.6 kg of gel flesh, grind twice with a colloid mill and filter through a 100 mesh sieve, collect about 22.8 kg of fresh aloe mucilage;

[0075] 2. Preparation of tremella powder: Take 8.0 kg of dried tremella, superfinely grind and sieve through a 100 mesh sieve to obtain about 7.7 kg of tremella powder;

[0076] 3. Construction of mixed system: Add 7.7 kg of tremella powder to 22.8 kg of fresh aloe mucilage, stir at a speed of 160 rpm for 16 min to form a uniform mixed slurry;

[0077] 4. Ultrasonic extraction: Add 49.1 kg of purified water to the mixed slurry, ultrasonic power 380 W, extraction temperature 60°C, extraction time 40 min;

[0078] 5. Post-treatment: Filter and combine the filtrate and washing liquid, concentrate to 25% solid at 65°C and -0.085 MPa to obtain about 18.9 kg of mixed extract, store at 4°C for standby.

[0079] (2) Preparation of content

[0080] 1. Weigh 8.0 kg of coenzyme Q10, 72.0 kg of soybean oil, 1.8 kg of vitamin E, and 1.2 kg of phospholipid, and add to an 80 L stirring tank;

[0081] 2. Set the temperature to 35°C and the stirring speed to 400 rpm, stir for 19 min, and then store the uniform and transparent mixed liquid at 35°C for standby.

[0082] (3) Preparation of wall material

[0083] 1. Weigh 30.0 kg of gelatin, 14.0 kg of glycerol, and 40.0 kg of purified water, and add to a 120 L dissolving tank, stir at 55°C and 250 rpm for 35 min until the gelatin is dissolved;

[0084] 2. Add 7.0 kg of aloe-tremella mixed extract, continue stirring for 25 min, and detect the viscosity to be 6200 mPa·s, then store at 47°C for standby.

[0085] (4) Pill forming

[0086] 1. Set the content storage tank to 35°C and the wall material liquid storage tank to 47°C, and set the pill pressing parameters as follows: temperature 27°C, stirring speed 3.0 r / min, rubber thickness 1.0 mm, and specification 0.5 g / pill;

[0087] 2. After the trial production qualified, the formal production, get about 2.4 million soft capsule.

[0088] (5) shaping and drying

[0089] 1. Shaping machine parameters: 22℃, 45% RH, 0.6m / min, shaping 14h;

[0090] 2. Dryer parameters: 28℃, 1.5m / s, dry 10h, detect moisture content 9.6%;

[0091] 3. After screening, get about 229.2 million finished products, the qualified rate is about 95.5%.

[0092] Example 3

[0093] (1) Aloe-tremella mixed extract preparation

[0094] 1. Fresh aloe pretreatment: take fresh aloe leaves 60.0kg, after washing and peeling, take gel flesh about 38.4kg, grind twice with colloid mill and filter with 100 mesh, collect fresh aloe slime about 34.2kg;

[0095] 2. Tremella powder preparation: take dried tremella 11.4kg, supermicro grind and sieve with 100 mesh, get tremella powder about 11.0kg;

[0096] 3. Mixed system construction: add 11.0kg tremella powder to 34.2kg fresh aloe slime, stir at 200rpm for 20min, form uniform mixed slurry;

[0097] 4. Ultrasonic extraction: add purified water 98.8kg to the mixed slurry, ultrasonic power 500W, 70℃, 60min extraction;

[0098] 5. Post-treatment: combine filtrate and washing liquid, concentrate to solid content 30% at 70℃, -0.075MPa, get mixed extract about 30.1kg, 4℃ refrigeration standby.

[0099] (2) Content preparation

[0100] 1. Take coenzyme Q10 12.0kg, soybean oil 82.0kg, vitamin E 3.2kg, phospholipid 1.8kg, add to 80L stirring tank;

[0101] 2. 40℃, 500rpm stirring 22min, 39℃ standby.

[0102] (3) Wall material preparation

[0103] 1. Take gelatin 34.0 kg, glycerol 18.0 kg, purified water 44.0 kg, 60°C, 300 rpm stirring for 40 min until the gelatin is dissolved;

[0104] 2. Add mixed extract 11.0 kg, stir for 30 min, viscosity 8400 mPa·s, 50°C standby.

[0105] (4) Pill compression molding

[0106] 1. The content 39°C, wall material liquid 50°C, pill compression parameters: 30°C, 4.0 r / min, 1.2 mm, 0.7 g / pill;

[0107] 2. The formal production gets about 1714 million initial molding soft capsules.

[0108] (5) Shaping and drying

[0109] 1. The shaper 25°C, 50% RH, 0.6 m / min, shaping 16 h;

[0110] 2. The dryer 31°C, 2.0 m / s, drying 12 h, moisture 11.0%;

[0111] 3. After screening, the finished product is about 1638 million particles, and the qualified rate is about 95.6%.

[0112] Comparative Example 1

[0113] Replace 9.0 kg of aloe-silver fungus mixed extract with 3.5 kg of gelatin + 2.0 kg of glycerol + 3.5 kg of purified water in the wall material, and other preparation steps are consistent with Example 1.

[0114] Comparative Example 2

[0115] Replace 9.0 kg of aloe-silver fungus mixed extract with 9.0 kg of fresh aloe extract alone (only take fresh aloe mucilage, extract and concentrate according to steps W4-W5 of Example 1, without silver fungus powder), and other preparation steps are consistent with Example 1.

[0116] Comparative Example 3

[0117] Replace 9.0 kg of aloe-silver fungus mixed extract with 9.0 kg of silver fungus extract alone (only take silver fungus powder, extract and concentrate according to steps W4-W5 of Example 1, without fresh aloe mucilage, and the amount of purified water added is 9-13 times the mass of silver fungus powder), and other preparation steps are consistent with Example 1.

[0118] Comparative Example 4

[0119] When preparing the mixed extract, the mass ratio of fresh aloe mucilage to silver fungus powder is 0.8:1, and other preparation steps are consistent with Example 1.

[0120] Comparative Example 5

[0121] In the wall material, 9.0 kg of aloe-tremella mixed extract was replaced with 9.0 kg of aloe-poria mixed extract (i.e., dried poria powder was used instead of tremella powder during preparation, and other extraction processes and parameters were the same as in Example 1), and other preparation steps were the same as in Example 1.

[0122] Comparative Example 6

[0123] In the wall material, 9.0 kg of aloe-tremella mixed extract was replaced with 9.0 kg of aloe-yam mixed extract (i.e., dried yam powder was used instead of tremella powder during preparation, and other extraction processes and parameters were the same as in Example 1), and other preparation steps were the same as in Example 1.

[0124] Comparative Example 7

[0125] In the wall material, 9.0 kg of aloe-tremella mixed extract was replaced with 9.0 kg of aloe-astragalus mixed extract (i.e., dried astragalus powder was used instead of tremella powder during preparation, and other extraction processes and parameters were the same as in Example 1), and other preparation steps were the same as in Example 1.

[0126] Comparative Example 8

[0127] In the wall material, 9.0 kg of aloe-tremella mixed extract was replaced with 9.0 kg of aloe-ophiopogon mixed extract (i.e., dried ophiopogon powder was used instead of tremella powder during preparation, and other extraction processes and parameters were the same as in Example 1), and other preparation steps were the same as in Example 1.

[0128] Comparative Example 9

[0129] In the wall material, 9.0 kg of aloe vera-tremella mixed extract was replaced with 9.0 kg of aloe vera-goji berry mixed extract (i.e., dried goji berry powder was used instead of tremella powder during preparation, and other extraction processes and parameters were the same as in Example 1), and other preparation steps were the same as in Example 1.

[0130] Performance testing

[0131] Disintegration time limit detection

[0132] Reagent preparation: Artificial gastric juice (pH 1.2) - Take 16.4 mL of dilute hydrochloric acid, add 800 mL of purified water, stir well, add 10.0 g of pepsin (enzyme activity ≥ 1200 U / g), dissolve, and bring the volume to 1000 mL. Adjust the pH to 1.2 ± 0.05 with 0.1 mol / L NaOH. Prepare fresh and use immediately.

[0133] Instrument parameters: disintegration cup temperature 37℃±0.5℃, stirring speed 100r / min, mesh size 2mm.

[0134] Sample preparation: Take 6 soft capsules, remove surface adhering substances, and place them into the baskets of 6 disintegration tubes respectively.

[0135] Operating steps:

[0136] ① Add artificial gastric fluid to the disintegration cup until it covers the basket by 50 mm, start heating and stirring, and wait for the temperature to stabilize at 37℃±0.5℃;

[0137] ② Place the disintegration tube containing the capsule into the disintegration cup and start timing;

[0138] ③ Observe every 5 minutes and record the time it takes for each capsule to completely disintegrate (definition: the capsule shell is completely broken, all contents are released, and there are no obvious glue residues).

[0139] ④ Calculate the average disintegration time of 6 capsules (retain 1 decimal place), and the results are shown in Table 1.

[0140] Content leakage rate detection

[0141] Instruments and consumables: Electronic balance with an accuracy of 0.1 mg, filter paper (quantitative slow filter paper, 11 cm in diameter, dried to constant weight at 105℃), and constant temperature incubator (40℃±1℃).

[0142] Sample preparation: Take 20 soft capsules and equilibrate them at 25℃ for 1 hour. Randomly select 10 capsules, gently blot the surface with filter paper, and accurately weigh the total mass (m1, accurate to 0.0001g).

[0143] Operating steps:

[0144] ① Place the weighed 10 capsules flat in a petri dish and put it in a constant temperature incubator at 40℃±1℃ for 24 hours (avoiding the capsules from coming into contact with each other).

[0145] ② Remove the capsule and gently blot away any oil seepage from the surface with pre-weighed filter paper (m0) (use a new filter paper for each capsule to avoid cross-contamination).

[0146] ③ Weigh the total mass of 10 capsules again (m2, accurate to 0.0001g).

[0147] ④ Calculation formula: Infiltration rate (%) = (m1-m2) / m1×100% (retain 2 decimal places), the results are shown in Table 1.

[0148] Stability test

[0149] Light stability test

[0150] Ten capsules from the same batch of coenzyme Q10 soft capsules prepared in Examples 1-3 and Comparative Examples 1-9 were taken as implementation groups 1-3 and control groups 1-9, respectively. Five capsules from each group were randomly selected, and their contents were extracted. The concentration of coenzyme Q10 was determined by high performance liquid chromatography, and the average value was calculated and recorded as C0. The remaining five capsules from each group were sealed in a transparent plastic bag, vacuum-sealed, and placed in direct sunlight for 30 days. The contents were extracted again, and the concentration of coenzyme Q10 was determined. The average value was calculated and recorded as C1. The preservation rate Q value was calculated as follows: Q = 100% × C1 / C0. The results are shown in Table 2.

[0151] Oxidative stability test

[0152] Ten capsules from the same batch of coenzyme Q10 soft capsules prepared in Examples 1-3 and Comparative Examples 1-9 were taken as implementation groups 1-3 and control groups 1-9, respectively. Five capsules from each group were randomly selected, and their contents were extracted. The concentration of coenzyme Q10 was determined using the high-performance liquid chromatography method described above, and the average value was calculated and recorded as C0. The remaining five capsules from each group were placed in air at 25°C and 60% relative humidity for 30 days. The contents were extracted again, and the concentration of coenzyme Q10 was determined. The average value was calculated and recorded as C1. The retention rate Q value was calculated as follows: Q = 100% × C1 / C0. The results are shown in Table 2.

[0153] Table 1. Results of Disintegration Time and Content Leakage Rate Detection

[0154]

[0155] Table 2 Stability test results

[0156]

[0157] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any way. Although the present invention has been disclosed above with reference to preferred embodiments, it is not intended to limit the present invention. Any person skilled in the art can make some modifications or alterations to the above-disclosed technical content to create equivalent embodiments without departing from the scope of the present invention. Any simple modifications, equivalent changes and alterations made to the above embodiments based on the technical essence of the present invention without departing from the scope of the present invention shall still fall within the scope of the present invention.

Claims

1. A coenzyme Q10 soft capsule, characterized in that, It consists of contents and wall material in a mass ratio of 1:0.9-1.

3.

2. The coenzyme Q10 soft capsule according to claim 1, characterized in that, The contents consist of the following components in parts by weight: 5-15 parts coenzyme Q10, 70-85 parts soybean oil, 1-4 parts vitamin E, and 1-2 parts phospholipids.

3. A coenzyme Q10 soft capsule according to claim 1, characterized in that, The wall material is composed of the following components in parts by weight: 28-36 parts gelatin, 13-19 parts glycerin, 6-13 parts aloe vera-tremella mixed extract, and 38-46 parts purified water.

4. A coenzyme Q10 soft capsule according to claim 3, characterized in that, The preparation method of the aloe vera-tremella mixed extract includes the following steps: W1. Fresh aloe vera pretreatment: Take fresh aloe vera leaves, wash and peel them, then take the gel-like pulp, grind it into a paste using a colloid mill, filter it through a 100-mesh filter cloth, and collect the fresh aloe vera mucus. W2. Preparation of Tremella powder: Take dried tremella and grind it into 80-120 mesh powder; W3. Construction of the mixed system: According to the mass ratio of fresh aloe vera mucilage to tremella powder of 1.2-2.0:1, add tremella powder to fresh aloe vera mucilage and stir at 150-200 rpm for 15-20 min to form a mixed slurry; W4. Ultrasonic extraction: Add purified water to the mixed slurry. The total mass of fresh aloe vera mucus and purified water is 9-13 times the mass of tremella powder. Perform ultrasonic extraction under the conditions of ultrasonic power of 350-550W, extraction temperature of 55-75℃ and extraction time of 35-65min. W5. Post-processing: The extract is filtered through a 100-mesh filter cloth, and the filtrate is concentrated under reduced pressure at 62-72℃ and a vacuum degree of -0.09~-0.07MPa until the solid content is 22-32%.

5. A coenzyme Q10 soft capsule according to claim 1 or 2, characterized in that, The contents consist of the following components in parts by weight: 10 parts coenzyme Q10, 78 parts soybean oil, 2.5 parts vitamin E, and 1.5 parts phospholipids.

6. A coenzyme Q10 soft capsule according to claim 1 or 3, characterized in that, The wall material is composed of the following components in parts by weight: 32 parts gelatin, 16 parts glycerin, 9 parts aloe vera-tremella mixed extract, and 42 parts purified water.

7. A coenzyme Q10 soft capsule according to claim 4, characterized in that, The mass ratio of fresh aloe vera mucus to tremella powder is 1.5:

1.

8. A method for preparing coenzyme Q10 soft capsules as described in any one of claims 1-7, characterized in that, Includes the following steps: X1. Add coenzyme Q10, soybean oil, vitamin E, and phospholipids to a mixing bowl, stir at a constant temperature until well mixed; X2. Add gelatin, glycerin, and purified water to a dissolving vessel and stir at a constant temperature of 52-62℃ for 32-42 minutes until the gelatin is completely dissolved. Add aloe vera-tremella mixed extract and continue stirring for 22-32 minutes at a speed of 220-320 rpm. Keep warm at 46-51℃. X3. Input the contents and wall material liquid into the soft capsule pelleting machine, with a pelleting temperature of 26-31℃, a roller speed of 2.5-4.5r / min, and a capsule thickness of 0.9-1.3mm, and press into shape; Set at 4.21-26℃ and relative humidity for 13-17 hours, then dry to obtain the product.

9. The method for preparing a coenzyme Q10 soft capsule according to claim 8, characterized in that, The constant temperature stirring mentioned in step X1 refers to stirring at 350-550 rpm for 18-23 minutes at 32-42℃.

10. The method for preparing a coenzyme Q10 soft capsule according to claim 8, characterized in that, The drying process described in step X4 refers to drying at 26-32℃ and a wind speed of 1.2-2.2m / s for 9-13 hours.

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