Sour cherry powder sustained-release preparation with stable uric acid reducing effect and preparation process of sour cherry powder sustained-release preparation

Abstract

The invention relates to the technical field of food sustained-release preparations, and particularly discloses a sour cherry powder sustained-release preparation with a stable uric acid reducing effect and a preparation process of the sour cherry powder sustained-release preparation. The sour cherry powder sustained-release preparation comprises a core active phase freeze-dried sour cherry powder, a sustained-release carrier phase, a synergistic function phase, an auxiliary regulation phase and a filler, the synergistic functional phase contains a celery seed extract, a curcumin-phospholipid complex, a prebiotic complex and the like, and all the components have a synergistic effect. The preparation method comprises the following steps: carrying out wall breaking, enzymolysis, purification and freeze-drying treatment on sour cherry fruits to obtain a core raw material, compounding the core raw material with other components, and carrying out slow-release carrier construction, coating granulation and other steps to prepare the microcapsule structure preparation. The preparation can be used for assisting in reducing the uric acid level, and has the advantages of high stability of active ingredients, continuous and stable uric acid reducing effect, consideration to intestinal health and the like; the preparation process adopts freeze-drying and micro-capsule coating technologies, effectively retains active ingredients, is controllable in operation, and is suitable for large-scale production.

Description

Technical Field

[0001] The present application relates to the technical field of sustained-release food preparations, and more specifically, to a sour cherry powder sustained-release preparation with a stable uric acid-lowering effect and a preparation process thereof. Background Art

[0002] Tart cherry is a fruit rich in a variety of bioactive ingredients, including anthocyanins, flavonoids, vitamin C and various minerals. Studies in recent years have shown that tart cherry has many health benefits such as anti-inflammatory, antioxidant, and lowering uric acid levels. In particular, its effect of lowering uric acid has important therapeutic significance for gout patients.

[0003] Hyperuricemia is the main cause of gout. Long-term hyperuricemia may also cause health problems such as kidney stones and renal impairment. Traditional tart cherry powder has low bioavailability and unstable effects when taken directly, because the active ingredients of unprocessed tart cherry powder are easily degraded by temperature and light and have poor stability. After oral administration, it is released too quickly in the gastrointestinal tract, has low bioavailability, and is difficult to achieve a sustained uric acid-lowering effect. Summary of the Invention

[0004] In order to solve the problems of low bioavailability and unstable effect of untreated sour cherry powder in the prior art, the present application provides a sour cherry powder sustained-release preparation with stable uric acid-lowering effect and a preparation process thereof.

[0005] In the first aspect, the present application provides a sour cherry powder sustained-release preparation with a stable uric acid-lowering effect, which adopts the following technical solution:

[0006] A sour cherry powder sustained-release preparation with a stable uric acid-lowering effect is composed of the following components in the following mass percentages:

[0007] Core active phase: 52%-58% freeze-dried sour cherry powder, with anthocyanin content ≥8% and urate oxidase activity ≥250U / g;

[0008] Sustained-release carrier phase: whey protein isolate 10%-13%;

[0009] Synergistic functional phase: 3%-4% celery seed extract, of which 3-n-butylphthalide content is ≥8%; 2%-3% by weight of curcumin phospholipid complex; 8%-9% by weight of prebiotic complex, composed of oligoxylose and inulin in a mass ratio of 1:2-1:3;

[0010] Auxiliary regulating phase: magnesium citrate 1%-1.2%, vitamin B6 0.5%-0.6%;

[0011] Filler: sodium alginate as the balance, the sum of all components being 100%; the preparation is a microcapsule structure, and the microcapsule particle size is 20-50 μm.

[0012] By adopting the above technical solution, the anthocyanins and uricase in the freeze-dried tart cherry powder are retained. These active ingredients play an important role in lowering uric acid levels in the blood. Anthocyanins, as a powerful antioxidant, help reduce oxidative stress and inflammatory responses, while uricase is directly involved in the metabolism of uric acid, promoting its decomposition and excretion. The addition of whey protein isolate provides a stable sustained-release carrier, which helps control the release rate of the active ingredients in the freeze-dried tart cherry powder and prolong the retention time of the preparation in the body, thereby improving its bioavailability and efficacy.

[0013] Preferably, the filler sodium alginate and whey protein isolate are modified by ionic cross-linking, the cross-linking agent is a 0.1-0.3 mol / L CaCl2 solution, and the mass ratio of protein to calcium ion is 10:1-15:1.

[0014] By adopting the above technical solution and this ionic cross-linking modification technology, the overall stability and sustained-release effect of the preparation have been significantly improved. This modification not only enhances the interaction between protein and sodium alginate, but also helps to control the release rate of active ingredients and prolong the retention time of the preparation in the body, thereby improving efficacy and safety.

[0015] Preferably, the polyphenol content in the freeze-dried sour cherry powder is ≥15%, and the flavonoid content is ≥12%.

[0016] By adopting the above technical solution and ensuring the high content of polyphenols and flavonoids in freeze-dried tart cherry powder, the preparation can not only effectively lower uric acid levels, but also provide additional health benefits such as anti-inflammatory, antioxidant and cardiovascular protection.

[0017] In a second aspect, the present application provides a preparation process for a sour cherry powder sustained-release preparation having a stable uric acid-lowering effect, using the following technical solution:

[0018] The preparation process of a sour cherry powder sustained-release preparation having a stable uric acid-lowering effect comprises the following steps:

[0019] S1. Raw material wall breaking process: sour cherry fruits are quick-frozen at -25℃ to -30℃ for 4-6 hours and broken into 3-5mm pulp;

[0020] S2, directional enzymatic extraction: add 0.5%-1.0% pectinase and 0.3%-0.8% cellulase by weight of the fruit pulp, pH 4.0-4.5, enzymatic hydrolysis at 45-50℃ for 1.5-2.5 hours, and inactivate the enzyme at 90℃ for 10 minutes;

[0021] S3. Active enrichment and purification: The enzymatic hydrolysate was filtered through a 100-200 mesh sieve and purified using an ultrafiltration membrane with a molecular weight cut-off of 8000-12000Da;

[0022] S4, freeze drying and solidification: freeze drying at -55℃ to -60℃ and pressure ≤10Pa for 18-24 hours;

[0023] S5. Construction of sustained-release carrier: freeze-dried powder was mixed with whey protein isolate and sodium alginate, and homogenized under high pressure at 80-100 MPa for 2-3 times;

[0024] S6. Coating granulation: methacrylic acid-ethyl acrylate copolymer is used for coating in a fluidized bed, with the bed temperature controlled at 38-42°C, atomization pressure at 0.15-0.25 MPa, and coating weight gain at 15%-20%;

[0025] S7. Functional compounding and synergistic enhancement: Mix the coated microcapsules with celery seed extract, curcumin phospholipid complex, magnesium citrate and vitamin B6 in an environment with a humidity of ≤30% for 30 minutes;

[0026] S8. Storage: Store the product in sealed packaging.

[0027] By adopting the above technical solution, the cell structure of the raw material is destroyed through the wall-breaking treatment, making the active ingredients inside easier to extract and release. At the same time, the enzymatic hydrolysis process can specifically decompose the pectin and cellulose in the pulp, releasing more polyphenols and flavonoids. At the same time, the enzyme inactivation step ensures the controllability of the enzymatic hydrolysis process and prevents excessive decomposition. The freeze-drying technology retains the stability and biological activity of the active ingredients while reducing moisture, facilitating subsequent preparation processing. The coating process provides an additional protective layer for the microcapsules, enhancing the stability and sustained-release properties of the product. At the same time, the coating weight gain is adjusted to control the release rate. The resulting sour cherry powder sustained-release preparation can effectively lower uric acid levels.

[0028] Preferably, in step S5, the whey protein isolate solution is first heat-denatured at 85-90° C. for 10-15 minutes, and then compounded with sodium alginate at a solid content of 18%-22%.

[0029] By adopting the above technical solution, not only the stability and functionality of the sustained-release carrier are enhanced, but also a more controllable sustained-release platform is provided for the preparation.

[0030] Preferably, in step S6, the coating solution is added with celery seed extract encapsulated by β-cyclodextrin, the mass ratio of core material to wall material is 1:4-1:6; the nozzle aperture is 0.8-1.2 mm, and the microcapsule particle size is controlled at 20-50 μm; the prebiotic complex is coated on the outer layer of the microcapsule.

[0031] By adopting the above technical solution, the beta-cyclodextrin inclusion improves the stability and bioavailability of the active ingredients in the celery seed extract, reduces degradation during the preparation process, and improves the therapeutic effect.

[0032] Preferably, in step S3, the operating pressure of the ultrafiltration membrane purification is 0.4-0.6 MPa, the temperature is 35-40°C, and the transmembrane flow rate is 5-10 L / (m 2 ·h).

[0033] By adopting the above technical solution, not only the purity and activity of the active ingredients are improved, but also the efficiency and stability of the ultrafiltration membrane purification process are ensured.

[0034] Preferably, in step S8, the product is placed in a chamber with an oxygen transmission rate of ≤0.1 cc / m 2 / day in nitrogen-filled aluminum foil bags.

[0035] By adopting the above technical solution, the air in the packaging bag is removed and replaced with nitrogen, thereby reducing the impact of oxygen on the product and reducing the possibility of oxidation reaction.

[0036] Preferably, the β-cyclodextrin inclusion process conditions are: 55-60°C for 2-3 hours, stirring rate 200-300 rpm

[0037] By adopting the above technical solution, the stability and bioavailability of the active ingredients in the celery seed extract can be effectively improved, providing the preparation with more stable and efficient active ingredients.

[0038] Preferably, in step S5, the high-pressure homogenization is carried out in two stages: the first stage is 80 MPa treatment for 2 minutes, and the second stage is 100 MPa treatment for 1 minute.

[0039] By adopting the above technical solution, the purpose of the first stage is to preliminarily disperse the mixture and form a preliminary microcapsule structure; the purpose of the second stage is to further refine and homogenize the microcapsule structure and improve its stability and sustained-release performance.

[0040] In summary, this application has the following beneficial effects:

[0041] 1. Since the content of freeze-dried sour cherry powder in this application is in the range of 52%-58%, this range can ensure that the urate oxidase activity reaches 265-295U / g, thereby stabilizing the serum uric acid concentration at 310-330μmol / L, thereby achieving the effect of stabilizing the core uric acid-lowering function, avoiding the problem of weakening the function due to too low a content or damaging the preparation structure due to too high a content.

[0042] 2. In this application, it is preferred to adopt a multi-component combination of a core active phase, a sustained-release carrier phase, a synergistic functional phase and an auxiliary regulatory phase. Due to the synergistic effect of each component, even if the urate oxidase activity is similar, it can still significantly reduce the serum uric acid concentration and increase the anthocyanin retention rate, thereby achieving the effect of highly efficient and stable uric acid lowering and more stable active ingredients.

[0043] 3. Since this application adopts a 20-50 μm microcapsule structure and ionic cross-linking modification of whey protein isolate and sodium alginate, the microcapsule formation rate reaches 94%-96%, which can reduce the degradation of active ingredients, thereby achieving the effect of extending the action time of active ingredients and reducing the risk of degradation of active ingredients, which is better than preparations without a sustained-release structure.

[0044] 4. In this application, natural ingredients and prebiotic complexes are preferably used. Since natural ingredients improve the microcapsule formation rate and prebiotics regulate the intestinal environment, the preparation structure is stable and the active ingredient retention rate is high, thereby achieving the effect of improving the stability of the preparation and taking into account intestinal health and metabolic regulation. BRIEF DESCRIPTION OF THE DRAWINGS

[0045] Figure 1 This is a flow chart of the preparation process of the sour cherry powder sustained-release preparation with stable uric acid-lowering effect provided in this application. DETAILED DESCRIPTION

[0046] The present application is further described in detail below with reference to the accompanying drawings and examples.

[0047] Technical conception:

[0048] Traditional sour cherry powder has problems of low bioavailability and unstable effects when taken directly. The active ingredients in unprocessed sour cherry powder are easily degraded by temperature and light, have poor stability, and are difficult to preserve and exert their effects for a long time. After oral administration, they are released too quickly in the gastrointestinal tract, have low bioavailability, and cannot form a sustained and stable uric acid-lowering effect. The effect of a single ingredient is limited, and it is difficult to take into account multiple links of regulation such as inhibiting uric acid production and promoting excretion, resulting in insufficient overall efficacy.

[0049] This application solves the corresponding problems through the following three technical means:

[0050] The core active phase is freeze-dried sour cherry powder, which contains urate oxidase and anthocyanins as core uric acid-lowering substances. The content range is clearly defined to ensure sufficient activity and avoid imbalance in the formulation structure.

[0051] The introduction of synergistic components such as celery seed extract and curcumin phospholipid complex and auxiliary ingredients such as prebiotics and vitamin B6 forms a multi-component synergistic system to enhance the effect of multiple links in uric acid metabolism;

[0052] The whey protein isolate-sodium alginate ion cross-linked microcapsule structure and coating process are used to achieve sustained release of active ingredients, prolong drug efficacy and reduce side effects, while improving ingredient stability.

[0053] Preparation Example 1

[0054] The steps for preparing freeze-dried tart cherry powder are as follows:

[0055] Take 10kg of Tartarian sour cherry fruit, first freeze it at -28°C for 5 hours, then quickly freeze it in liquid nitrogen, and crush it into pieces no larger than 3mm in size. Then add 8L of pure water, adjust the pH to 4.2, add 0.8% pectinase and 0.55% cellulase (based on the weight of the fruit pulp), and stir and hydrolyze it at 47°C for 2 hours. Then, heat it to 90°C and hold it for 10 minutes to inactivate the enzymes.

[0056] The liquid after enzymatic hydrolysis was first passed through a 150-mesh sieve and then filtered through an ultrafiltration membrane with a molecular weight cutoff of 10 kDa. The pressure was controlled at 0.5 MPa, the temperature was 38°C, and the flow rate was 7.5 L / (m 2 h). Finally, the purified liquid was frozen at -58°C for 4 hours, and then freeze-dried in a vacuum environment at -60°C and 5 Pa for 20 hours to obtain freeze-dried sour cherry powder.

[0057] Preparation Example 2

[0058] The preparation steps of β-cyclodextrin inclusion celery seed extract are as follows:

[0059] Take 1 kg of celery seed powder, add 10 L of water, and extract at 125°C and 8.5 MPa for 50 minutes. Concentrate the extract on a rotary evaporator at 40°C until the solids concentration reaches 25%.

[0060] Celery seed extract and β-cyclodextrin were weighed in a weight ratio of 1:5, mixed, and then added with an appropriate amount of water. The mixture was stirred at 250 rpm and 58°C for 2.5 hours. The reaction mixture was treated in a spray dryer with an inlet temperature of 170°C and an outlet temperature of 85°C to obtain an inclusion compound powder.

[0061] Preparation Example 3

[0062] The preparation steps of curcumin phospholipid complex are as follows:

[0063] Curcumin and soybean lecithin were weighed in a mass ratio of 1:2. Anhydrous ethanol was added at a solid-to-liquid ratio of 1:10 and stirred at 50°C to fully dissolve the raw materials. The mixture was then subjected to reduced pressure rotary evaporation at 60°C and -0.08 MPa to remove the ethanol and obtain a yellow semi-solid.

[0064] Petroleum ether was added to the semi-solid, stirred, and allowed to stand. The supernatant was decanted and washed three times to remove unbound curcumin. The solid was collected by filtration, dried at 50°C and -0.09 MPa in a vacuum environment, and pulverized to obtain the curcumin phospholipid complex.

[0065] The present application provides a sour cherry powder sustained-release preparation with a stable uric acid-lowering effect and a preparation process thereof. The following describes in detail the sour cherry powder sustained-release preparation with a stable uric acid-lowering effect and a preparation process thereof provided in the examples of the present application.

[0066] Example 1

[0067] According to the first aspect of the present application, this embodiment provides a sour cherry powder sustained-release preparation with a stable uric acid-lowering effect, which is composed of the following components in percentage by mass:

[0068] Core active phase: 55% freeze-dried sour cherry powder, with anthocyanin content ≥8%, uricase activity ≥250U / g, polyphenol content 16%, and flavonoids 13%;

[0069] Sustained-release carrier phase: whey protein isolate 11.5%;

[0070] Synergistic functional phase: 3.5% celery seed extract, of which 3-n-butylphthalide content is ≥ 8%; 2.5% curcumin phospholipid complex; 8.5% prebiotic complex, of which the mass ratio of xylo-oligosaccharides to inulin in the prebiotic complex is 1:2.5;

[0071] Auxiliary regulating phase: magnesium citrate 1.1%, vitamin B6 0.55%;

[0072] Filler: sodium alginate 17.35%;

[0073] The sour cherry powder sustained-release preparation is a microcapsule structure with a microcapsule particle size of 35 μm; the sodium alginate and whey protein isolate are modified by ion cross-linking with a 0.2 mol / LCaCl2 solution, and the mass ratio of protein to calcium ion is 12.5:1.

[0074] According to the second aspect of the present application, this embodiment provides a preparation process of a sour cherry powder sustained-release preparation with a stable uric acid-lowering effect, using the following technical solution:

[0075] S1. Raw material wall breaking process: sour cherry fruits were quick-frozen at -27℃ for 5 hours and crushed into 4mm pulp;

[0076] S2, directional enzymatic extraction: add 0.75% pectinase and 0.55% cellulase by weight of the fruit pulp, pH 4.25, enzymatic hydrolysis at 47.5℃ for 2 hours, and inactivate the enzyme at 90℃ for 10 minutes;

[0077] S3. Active enrichment and purification: The enzymatic solution was filtered through a 150-mesh sieve and purified with an ultrafiltration membrane with a molecular weight cutoff of 10,000 Da. The operating pressure was 0.5 MPa, the temperature was 37.5°C, and the transmembrane flow rate was 7.5 L / (m 2 h);

[0078] S4, freeze drying and solidification: freeze drying at -57.5℃ and pressure ≤10Pa for 21 hours;

[0079] S5. Construction of sustained-release carrier: The lyophilized powder was mixed with whey protein isolate and sodium alginate. The whey protein isolate solution was first heat-denatured at 87.5°C for 12.5 minutes, then compounded with sodium alginate at a solid content of 20%, and homogenized twice at 90 MPa. The high-pressure homogenization was carried out in two stages: 80 MPa for 2 minutes and 100 MPa for 1 minute.

[0080] S6. Coating and granulation: Coating was performed using methacrylic acid-ethyl acrylate copolymer in a fluidized bed. Celery seed extract encapsulated with β-cyclodextrin was added to the coating solution. The reaction was carried out at 57.5°C for 2.5 hours with a stirring rate of 250 rpm and a core material to wall material mass ratio of 1:5. The bed temperature was controlled at 40°C, the atomization pressure was 0.2 MPa, the coating weight gain was 17.5%, the nozzle aperture was 1.0 mm, and the microcapsule particle size was controlled at 35 μm. The prebiotic complex was coated on the outer layer of the microcapsules.

[0081] S7. Functional compounding and synergistic enhancement: Mix the coated microcapsules with celery seed extract, curcumin phospholipid complex, magnesium citrate and vitamin B6 in an environment with a humidity of ≤30% for 30 minutes;

[0082] S8. Storage: Store the product in a place with oxygen transmission rate ≤ 0.1cc / m 2 / day in nitrogen-filled aluminum foil bags.

[0083] Example 2

[0084] According to the first aspect of the present application, this embodiment provides a sour cherry powder sustained-release preparation with a stable uric acid-lowering effect, which is composed of the following components in percentage by mass:

[0085] Core active phase: freeze-dried sour cherry powder 58%, with anthocyanin content ≥8%, uricase activity ≥250U / g, polyphenol content 17%, and flavonoids 14%;

[0086] Sustained-release carrier phase: whey protein isolate 13%;

[0087] Synergistic functional phase: 4% celery seed extract, of which 3-n-butylphthalide content is ≥ 8%; 3% curcumin phospholipid complex; 9% prebiotic complex, of which the mass ratio of xylo-oligosaccharides to inulin in the prebiotic complex is 1:3;

[0088] Auxiliary regulating phase: magnesium citrate 1.2%, vitamin B6 0.6%;

[0089] Filler: sodium alginate 11.2%;

[0090] The sour cherry powder sustained-release preparation has a microcapsule structure with a microcapsule particle size of 50 μm; the sodium alginate and whey protein isolate are modified by ion cross-linking with a 0.3 mol / LCaCl2 solution, and the mass ratio of protein to calcium ion is 15:1.

[0091] According to the second aspect of the present application, this embodiment provides a preparation process of a sour cherry powder sustained-release preparation with a stable uric acid-lowering effect, using the following technical solution:

[0092] S1. Raw material wall breaking process: sour cherry fruits were quick-frozen at -25℃ for 6 hours and crushed into 5mm pulp;

[0093] S2, directional enzymatic extraction: add 1.0% pectinase and 0.8% cellulase by weight of the fruit pulp, pH 4.5, 50℃ enzymatic hydrolysis for 2.5 hours, and inactivate the enzyme at 90℃ for 10 minutes;

[0094] S3. Active enrichment and purification: The enzymatic solution was filtered through a 200-mesh sieve and purified with an ultrafiltration membrane with a molecular weight cutoff of 12,000 Da. The operating pressure was 0.6 MPa, the temperature was 40°C, and the transmembrane flow rate was 10 L / (m 2 h);

[0095] S4, freeze drying and solidification: freeze drying at -55 ° C, ≤ 10 Pa pressure for 24 hours;

[0096] S5. Construction of sustained-release carrier: The lyophilized powder was mixed with whey protein isolate and sodium alginate. The whey protein isolate solution was first heat-denatured at 90°C for 15 minutes, then compounded with sodium alginate at a solid content of 22%, and homogenized three times at 100 MPa. The high-pressure homogenization was carried out in two stages: 80 MPa for 2 minutes and 100 MPa for 1 minute.

[0097] S6. Coating and granulation: Coating was performed using methacrylic acid-ethyl acrylate copolymer in a fluidized bed. Celery seed extract encapsulated with β-cyclodextrin was added to the coating solution. The reaction was carried out at 60°C for 3 hours with a stirring rate of 300 rpm and a core material to wall material mass ratio of 1:6. The bed temperature was controlled at 42°C, the atomization pressure was 0.25 MPa, the coating weight gain was 20%, the nozzle aperture was 1.2 mm, and the microcapsule particle size was controlled at 50 μm. The prebiotic complex was coated on the outer layer of the microcapsules.

[0098] S7. Functional compounding and synergistic enhancement: Mix the coated microcapsules with celery seed extract, curcumin phospholipid complex, magnesium citrate and vitamin B6 in an environment with a humidity of ≤30% for 30 minutes;

[0099] S8. Storage: Store the product in a place with oxygen transmission rate ≤ 0.1cc / m 2 / day in nitrogen-filled aluminum foil bags.

[0100] Example 3

[0101] According to the first aspect of the present application, this embodiment provides a sour cherry powder sustained-release preparation with a stable uric acid-lowering effect, which is composed of the following components in percentage by mass:

[0102] Core active phase: freeze-dried sour cherry powder 52%, with anthocyanin content ≥8%, uricase activity ≥250U / g, polyphenol content 15%, and flavonoids 12%;

[0103] Sustained-release carrier phase: whey protein isolate 10%;

[0104] Synergistic functional phase: 3% celery seed extract, of which 3-n-butylphthalide content is ≥ 8%; 2% curcumin phospholipid complex; 8% prebiotic complex, of which the mass ratio of xylooligosaccharides to inulin in the prebiotic complex is 1:2;

[0105] Auxiliary regulating phase: magnesium citrate 1%, vitamin B6 0.5%;

[0106] Filler: sodium alginate 23.5%;

[0107] The sour cherry powder sustained-release preparation has a microcapsule structure with a microcapsule particle size of 20 μm; the sodium alginate and whey protein isolate are modified by ion cross-linking with a 0.1 mol / LCaCl2 solution, and the mass ratio of protein to calcium ion is 10:1.

[0108] According to the second aspect of the present application, this embodiment provides a preparation process of a sour cherry powder sustained-release preparation with a stable uric acid-lowering effect, using the following technical solution:

[0109] S1. Raw material wall breaking process: sour cherry fruits were quick-frozen at -30℃ for 4 hours and crushed into 3mm pulp;

[0110] S2, directional enzymatic extraction: add 0.5% pectinase and 0.3% cellulase by weight of the fruit pulp, pH 4.0, enzymatic hydrolysis at 45℃ for 1.5 hours, and inactivate the enzyme at 90℃ for 10 minutes;

[0111] S3. Active enrichment and purification: The enzymatic solution was filtered through a 100-mesh sieve and purified with an ultrafiltration membrane with a molecular weight cutoff of 8000Da. The operating pressure was 0.4MPa, the temperature was 35°C, and the transmembrane flow rate was 5L / (m 2 h);

[0112] S4, freeze drying and solidification: freeze drying at -60 ° C, ≤ 10 Pa pressure for 18 hours;

[0113] S5. Construction of sustained-release carrier: The lyophilized powder was mixed with whey protein isolate and sodium alginate. The whey protein isolate solution was first heat-denatured at 85°C for 10 minutes, then compounded with sodium alginate at a solid content of 18%, and homogenized twice at 80 MPa. The high-pressure homogenization was carried out in two stages: 80 MPa for 2 minutes and 100 MPa for 1 minute.

[0114] S6. Coating and granulation: Coating was performed using methacrylic acid-ethyl acrylate copolymer in a fluidized bed. Celery seed extract encapsulated with β-cyclodextrin was added to the coating solution. The reaction was carried out at 55°C for 2 hours with a stirring rate of 200 rpm and a core material to wall material mass ratio of 1:4. The bed temperature was controlled at 38°C, the atomization pressure was 0.15 MPa, the coating weight gain was 15%, the nozzle aperture was 0.8 mm, and the microcapsule particle size was controlled at 20 μm. The prebiotic complex was coated on the outer layer of the microcapsules.

[0115] S7. Functional compounding and synergistic enhancement: Mix the coated microcapsules with celery seed extract, curcumin phospholipid complex, magnesium citrate and vitamin B6 in an environment with a humidity of ≤30% for 30 minutes;

[0116] S8. Storage: Store the product in a place with oxygen transmission rate ≤ 0.1cc / m 2 / day in nitrogen-filled aluminum foil bags.

[0117] Comparative Example 1

[0118] This comparative example provides a sour cherry powder sustained-release preparation with a stable uric acid-lowering effect. The component ratio thereof differs from that of Example 1 only in that the content of freeze-dried sour cherry powder is reduced to 30%, and the reduced 25% is replaced by inulin, wherein the inulin is an inactive filler, and the proportions of the other components remain unchanged.

[0119] The preparation process of the above-mentioned sour cherry powder sustained-release preparation with a stable uric acid-lowering effect is exactly the same as that of Example 1, except that 25% inulin is added during the mixing of the raw materials to replace the reduced sour cherry powder.

[0120] Comparative Example 2

[0121] This comparative example provides a sour cherry powder sustained-release preparation with a stable uric acid-lowering effect. The component ratio thereof is different from that of Example 1 only in that the freeze-dried sour cherry powder is completely removed, 55% of the vacancy is replaced by inulin, and the proportions of other components remain unchanged.

[0122] The preparation process of the above-mentioned sour cherry powder sustained-release preparation with a stable uric acid-lowering effect is exactly the same as that of Example 1, except that the sour cherry fruit is removed from the raw material processing and inulin is directly used in the subsequent steps.

[0123] Comparative Example 3

[0124] This comparative example provides a sour cherry powder sustained-release preparation with a stable uric acid-lowering effect. The component ratio thereof differs from that of Example 1 only in that the content of freeze-dried sour cherry powder is increased to 70%, and the filler sodium alginate is correspondingly reduced to 2.35%, while the proportions of other components remain unchanged.

[0125] The preparation process of the above-mentioned sour cherry powder sustained-release preparation with a stable uric acid-lowering effect is exactly the same as that of Example 1, except that the feeding amounts of freeze-dried sour cherry powder and sodium alginate are adjusted.

[0126] Comparative Example 4

[0127] This comparative example provides a sour cherry powder sustained-release preparation with a stable uric acid-lowering effect. The component ratio thereof is different from that of Example 1 in that only freeze-dried sour cherry powder and a basic carrier are retained, wherein the mass percentage of freeze-dried sour cherry powder is 55%, the mass percentage of whey protein isolate is 11.5%, and the mass percentage of sodium alginate is 33.5%.

[0128] The preparation process of the above-mentioned sour cherry powder sustained-release preparation with stable uric acid-lowering effect is completely consistent with Example 1, except that step S7 only mixes the coated microcapsules and the basic carrier without the synergistic component.

[0129] Comparative Example 5

[0130] This comparative example provides a sour cherry powder sustained-release preparation with a stable uric acid-lowering effect, and its component ratio is exactly the same as that of Example 1.

[0131] The preparation process of the above-mentioned sour cherry powder sustained-release preparation with a stable uric acid-lowering effect is as follows: the high-pressure homogenization step S5 and the coating and granulation step S6 are deleted, and the freeze-dried powder is directly mixed and pulverized with the components to obtain a particle size of 80-100 μm. The remaining steps are the same as those in Example 1.

[0132] Comparative Example 6

[0133] This comparative example provides a sour cherry powder sustained-release preparation with a stable uric acid-lowering effect. The component ratio thereof differs from that of Example 1 only in that artificially synthesized colloidal hydroxypropyl methylcellulose is used instead of sodium alginate, and the prebiotic complex is deleted. The proportions of the other components remain the same as those of Example 1.

[0134] The preparation process of the above-mentioned sour cherry powder sustained-release preparation with a stable uric acid-lowering effect is exactly the same as that of Example 1, except that the filler is replaced with hydroxypropyl methylcellulose and there is no prebiotic coating in step S6.

[0135] Test standards

[0136] Urate oxidase activity: spectrophotometric method according to GB / T35544-2017 Feed Additive Urate Oxidase;

[0137] Serum uric acid concentration: Technical Specifications for Inspection and Evaluation of Health Food (2003 edition);

[0138] Microcapsule formation rate: the percentage of complete microcapsules counted under an optical microscope;

[0139] Anthocyanin retention rate: HPLC method (GB / T22244-2008 Health Food Testing Method).

[0140] The experimental results of Examples 1-3 and Comparative Examples 1-6 are shown in Table 1.

[0141] Table 1:

[0142]

[0143] Combining Examples 1-3 and Control Group 1 and Table 1, it can be seen that the content of freeze-dried sour cherry powder in Examples 1-3 is in the range of 52%-58%, the uricase activity reaches 265-295 U / g, and the serum uric acid concentration is 310-330 μmol / L, while the sour cherry powder content in Control Group 1 is only 30%, the uricase activity decreases by 46% to 150 U / g, and the serum uric acid increases by 20% to 385 μmol / L, indicating that when the content is lower than the protection range, the core function is significantly weakened.

[0144] Combining Examples 1-3 and Control Group 2 and Table 1, it can be seen that because Examples 1-3 contain 52%-58% freeze-dried sour cherry powder, the uricase activity is maintained above 265 U / g, and the serum uric acid concentration is significantly reduced to 310-330 μmol / L. When Control Group 2 does not contain sour cherry powder, the uricase activity is 0 and the serum uric acid concentration is as high as 460 μmol / L, indicating that sour cherry powder is an essential ingredient to achieve the uric acid-lowering effect.

[0145] Combining Examples 1-3 and Control Group 3 with Table 1, it can be seen that the content of freeze-dried sour cherry powder in Examples 1-3 is 52%-58%, the microcapsule formation rate is 94%-96%, and the anthocyanin retention rate is 89%-91%, with good stability. However, the sour cherry powder content in Control Group 3 is 70%. Although the short-term uric acid level is slightly lower, the microcapsule formation rate drops sharply by 37% to 60%, and the anthocyanin retention rate drops by 28% to 65%, proving that exceeding the content standard will destroy the structure and stability of the preparation and affect the long-term effect.

[0146] Combining Examples 1-3 and Control Group 4 and Table 1, it can be seen that due to the synergistic effect of multiple components such as celery seed extract and curcumin phospholipid complex, Examples 1-3 have a urate oxidase activity close to that of Control Group 4, but the serum uric acid concentration is significantly reduced, and the anthocyanin retention rate is higher, and the microcapsule formation rate is stable, which proves that the synergistic effect of multiple components can not only enhance the uric acid lowering effect, but also improve the stability of the active ingredients.

[0147] Combining Examples 1-3 and Control Group 5 and Table 1, it can be seen that Examples 1-3 have a microcapsule formation rate of 94%-96% due to the use of a microcapsule sustained-release structure, while Control Group 5 has no formed microcapsules; at the same time, the serum uric acid concentrations of Examples 1-3 are significantly lower than those of Control Group 5, and the anthocyanin retention rate is much higher than that of Control Group 5, indicating that the sustained-release system prolongs the action time of the active ingredient by stabilizing the microcapsule structure and reduces the risk of degradation of the active ingredient.

[0148] Combining Examples 1-3 and Control Group 6 with Table 1, it can be seen that Examples 1-3 use natural ingredients, and the microcapsule formation rate reaches 94%-96%, while the formation rate of Control Group 6 is only 55%; the serum uric acid concentration of Examples 1-3 is significantly lower than that of Control Group 6, and the anthocyanin retention rate is much higher than that of Control Group 6, which proves that natural ingredients and prebiotics can improve the structural stability of the preparation and the retention rate of active ingredients, while taking into account intestinal health and metabolic regulation.

[0149] This specific embodiment is merely an explanation of the present application and is not a limitation of the present application. After reading this specification, those skilled in the art may make non-creative modifications to the present embodiment as needed, but as long as they are within the scope of the claims of the present application, they are protected by the patent law.

Claims

1. A sour cherry powder sustained-release preparation with a stable uric acid-lowering effect, characterized by: It is composed of the following components in percentage by mass: Core active phase: 52%-58% freeze-dried sour cherry powder, with anthocyanin content ≥8% and urate oxidase activity ≥250U / g; Sustained-release carrier phase: whey protein isolate 10%-13%; Synergistic functional phase: 3%-4% celery seed extract, of which 3-n-butylphthalide content is ≥8%; 2%-3% by weight of curcumin phospholipid complex; 8%-9% by weight of prebiotic complex, composed of oligoxylose and inulin in a mass ratio of 1:2-1:3; Auxiliary regulating phase: magnesium citrate 1%-1.2%, vitamin B6 0.5%-0.6%; Filler: sodium alginate as the balance, the sum of all components being 100%; the preparation is a microcapsule structure, and the microcapsule particle size is 20-50 μm.

2. The sour cherry powder sustained-release preparation with stable uric acid-lowering effect according to claim 1, characterized in that: The filler sodium alginate and whey protein isolate are modified by ion cross-linking, the cross-linking agent is 0.1-0.3 mol / LCaCl2 solution, and the mass ratio of protein to calcium ion is 10:1-15:

1.

3. The sour cherry powder sustained-release preparation with stable uric acid-lowering effect according to claim 1, characterized in that: The freeze-dried sour cherry powder has a polyphenol content of ≥15% and a flavonoid content of ≥12%.

4. A process for preparing a sustained-release sour cherry powder preparation having a stable uric acid-lowering effect, characterized in that: The sour cherry powder sustained-release preparation with a stable uric acid-lowering effect according to any one of claims 1 to 3 comprises the following steps: S1. Raw material wall breaking process: sour cherry fruits are quick-frozen at -25℃ to -30℃ for 4-6 hours and broken into 3-5mm pulp; S2, directional enzymatic extraction: add 0.5%-1.0% pectinase and 0.3%-0.8% cellulase by weight of the fruit pulp, pH 4.0-4.5, enzymatic hydrolysis at 45-50℃ for 1.5-2.5 hours, and inactivate the enzyme at 90℃ for 10 minutes; S3. Active enrichment and purification: The enzymatic hydrolysate was filtered through a 100-200 mesh sieve and purified using an ultrafiltration membrane with a molecular weight cut-off of 8000-12000Da; S4, freeze drying and solidification: freeze drying at -55℃ to -60℃ and pressure ≤10Pa for 18-24 hours; S5. Construction of sustained-release carrier: freeze-dried powder was mixed with whey protein isolate and sodium alginate, and homogenized under high pressure at 80-100 MPa for 2-3 times; S6. Coating granulation: methacrylic acid-ethyl acrylate copolymer is used for coating in a fluidized bed, with the bed temperature controlled at 38-42°C, atomization pressure at 0.15-0.25 MPa, and coating weight gain at 15%-20%; S7. Functional compounding and synergistic enhancement: Mix the coated microcapsules with celery seed extract, curcumin phospholipid complex, magnesium citrate and vitamin B6 in an environment with a humidity of ≤30% for 30 minutes; S8. Storage: Store the product in sealed packaging.

5. The preparation process of the sour cherry powder sustained-release preparation with stable uric acid-lowering effect according to claim 4, characterized in that: In step S5, the whey protein isolate solution is firstly heat-denatured at 85-90° C. for 10-15 minutes, and then compounded with sodium alginate at a solid content of 18%-22%.

6. The preparation process of the sour cherry powder sustained-release preparation with stable uric acid-lowering effect according to claim 4, characterized in that: In step S6, the coating solution is added with celery seed extract encapsulated by β-cyclodextrin, with a core material to wall material mass ratio of 1:4-1:6; the nozzle aperture is 0.8-1.2 mm, and the microcapsule particle size is controlled at 20-50 μm; and the prebiotic complex is coated on the outer layer of the microcapsule.

7. The preparation process of the sour cherry powder sustained-release preparation with stable uric acid-lowering effect according to claim 4, characterized in that: In step S3, the operating pressure of the ultrafiltration membrane purification is 0.4-0.6MPa, the temperature is 35-40°C, and the transmembrane flow rate is 5-10L / (m 2 ·h).

8. The preparation process of the sour cherry powder sustained-release preparation with stable uric acid-lowering effect according to claim 5, characterized in that: In step S8, the product is placed in an oxygen transmission rate of ≤0.1cc / m 2 / day in nitrogen-filled aluminum foil bags.

9. The preparation process of the sour cherry powder sustained-release preparation with stable uric acid-lowering effect according to claim 6, characterized in that: The β-cyclodextrin inclusion process conditions are: reaction at 55-60° C. for 2-3 hours and stirring rate of 200-300 rpm.

10. The preparation process of the sour cherry powder sustained-release preparation with stable uric acid-lowering effect according to claim 5, characterized in that: In step S5, the high-pressure homogenization is carried out in two stages: the first stage is 80 MPa for 2 minutes, and the second stage is 100 MPa for 1 minute.

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