High-activity non-denatured II-type collagen pet joint dispersible tablet and preparation method thereof

Abstract

The invention relates to the technical field of nutritional supplement preparations for pets, in particular to a high-activity non-denatured II-type collagen pet joint dispersible tablet and a preparation method thereof. According to the technical scheme, the soft capsule is prepared from the following raw materials in percentage by weight: 4.0%-7.0% of non-modified II type collagen, 4.0%-6.0% of sodium chondroitin sulfate, 4.0%-6.0% of green lip mussel powder, 0.5%-1.5% of sodium hyaluronate, 30%-40% of microcrystalline cellulose, 12%-18% of sodium carboxymethyl starch, 15%-22% of sweet potato starch, 4.0%-6.0% of polyvinylpolypyrrolidone, 6.0%-10.0% of enzymolysis chicken liver powder, 2.0%-4.0% of yeast extract, 1.5%-3.5% of lactose goat milk powder and 0.3%-0.7% of magnesium stearate. A core active component structure is protected by virtue of nano embedding and a whole-course low-temperature process, and a dual joint maintenance path of immunoregulation and nutrition supplement is constructed.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of pet nutritional supplement preparations, and particularly relates to a high-activity non-denatured type II collagen pet joint dispersible tablet and a preparation method thereof. BACKGROUND

[0002] With the continuous improvement of pet feeding refinement level, pet joint health problems have become a high-incidence health risk for common companion animals such as dogs, which seriously affects the quality of life of pets. According to industry research data, the incidence of joint disease in dogs over 6 years old has exceeded 40%, and the incidence risk of young pets, old pets and obese pets is significantly higher. The market demand for pet joint maintenance nutritional supplements is growing. At the same time, the physiological characteristics of the pet population vary greatly, especially young pets, old pets and pets with swallowing dysfunction, which puts forward higher requirements for the dosage form adaptability, feeding convenience and safety of nutritional supplements. The traditional products have been difficult to meet the diversified use demand.

[0003] At present, the mainstream dosage form of pet joint supplements on the market is mainly ordinary chewable tablets and direct compression tablets. The closest prior art to the present application is a "chondroitin sulfate plus glucosamine" combination type pet joint chewable tablet, which is prepared by a traditional dry compression process. The core provides nutritional support for joint cartilage through a direct nutritional supplement path, achieving a basic maintenance effect.

[0004] However, the prior art and similar traditional products have many inherent defects, which seriously restrict the use effect, safety and market adaptability of the products, which are specifically as follows: the dosage form has poor performance, the disintegration speed is slow, the disintegration time limit in water at 25℃ is generally more than 15 minutes, which leads to incomplete dissolution of effective ingredients, in-vivo absorption utilization rate ≤60%, a large amount of effective ingredients are wasted, and the maintenance effect is greatly reduced; the stability of active ingredients is poor, the high-temperature link in the traditional processing process can easily destroy the natural triple helix structure of non-denatured type II collagen (UC-II) and other active ingredients, leading to a deactivation rate of active ingredients of more than 40%, further reducing the core efficacy of the product; the mechanism is single, relying only on the nutritional supplement path of glucosamine and chondroitin, which cannot intervene in the joint inflammatory response from the immune regulation level, and the improvement effect on joint discomfort symptoms is limited; the safety is insufficient, the raw materials are mostly derived from seafood products, and generally contain glucosamine, MSM and other allergens, which have poor tolerance after being taken by pets with sensitive stomachs, and the incidence of allergic reactions is more than 8%; the tablet form needs to be actively chewed or swallowed by pets, and the refusal rate of young pets, old pets is more than 40%, which is completely not suitable for pets with swallowing dysfunction; the stability of the product is poor, the tablet structure is loose, the transportation damage rate is more than 15%, and the active ingredients are easily hydrolyzed and attenuated, and the active retention rate is ≤70% after 6 months of normal temperature storage, which cannot guarantee the efficacy stability of the product within the shelf life.

[0005] In summary, the existing pet joint supplements generally have low active ingredient retention rate, poor bioavailability, high allergy risk, insufficient feeding adaptability, and poor product stability, etc., which are difficult to balance the high maintenance effect, high safety and convenient use requirements. The market urgently needs a new type of pet joint nutritional supplement preparation that combines new technology and dosage form, with high active retention rate, high bioavailability, low sensitivity and flexible feeding characteristics, to solve many pain points of existing technology and meet the fine needs of pet joint maintenance. Therefore, the present application proposes a high-activity non-denatured type II collagen pet joint dispersible tablet and its preparation method. SUMMARY

[0006] The purpose of the present application is to address the problems of high inactivation rate of active ingredients, low bioavailability, high allergy risk, poor feeding adaptability, and insufficient product stability of existing pet joint chewable tablets in the background art, and to propose a high-activity non-denatured type II collagen pet joint dispersible tablet and its preparation method.

[0007] The technical solution of the present application: a high-activity non-denatured type II collagen pet joint dispersible tablet, which is composed of the following raw materials in weight percentage: non-denatured type II collagen 4.0%-7.0%, sodium chondroitin sulfate 4.0%-6.0%, green-lipped mussel powder 4.0%-6.0%, sodium hyaluronate 0.5%-1.5%, microcrystalline cellulose 30%-40%, carboxymethyl starch sodium 12%-18%, sweet potato starch 15%-22%, cross-linked polyvinylpyrrolidone 4.0%-6.0%, enzymatic chicken liver powder 6.0%-10.0%, yeast extract 2.0%-4.0%, 0 lactose goat milk powder 1.5%-3.5%, and magnesium stearate 0.3%-0.7%.

[0008] Optionally, the non-denatured type II collagen is chicken breast cartilage tissue, and the purity of the non-denatured type II collagen is 98.0%-99.5%, the particle size of the nano-embedded microcapsules is 8-15pm, and the embedding rate is 92.0%-95.0%;

[0009] The molecular weight of the sodium chondroitin sulfate is 4000-9000Da, and the purity is ≥95%;

[0010] The protein content of the green-lipped mussel powder is 60.0%-70.0%, and the moisture content is ≤6.0%-8.0%;

[0011] The molecular weight of the sodium hyaluronate is 1.0x106-2.2x106Da.

[0012] Optionally, the protein content of the enzymatic chicken liver powder is 70.0%-75.0%, and the enzymatic rate is 85.0%-90.0%;

[0013] The amino acid nitrogen content of the yeast extract is 2.8-3.2%, the lactose content of the 0-lactose goat milk powder is less than 0.5%, and the protein content is 28.0-32.0%.

[0014] Optionally, the microcrystalline cellulose has a particle size of 80-100 mesh and a fluidity of 18-22 cm / 100 s;

[0015] The sodium carboxymethyl starch has a water absorption expansion rate of 300-400% and a degree of substitution of 0.5-0.8.

[0016] The cross-linked povidone has a specific surface area of 1.2-1.5 m² / g.

[0017] The moisture content of the sweet potato starch is less than or equal to 12.0%.

[0018] The application further provides a preparation method of the high-activity non-denatured type II collagen pet joint dispersible tablet.

[0019] Step one, raw material grouping treatment:

[0020] a) The auxiliary material group: the microcrystalline cellulose, the sweet potato starch, the enzymatic chicken liver powder, the yeast extract, and the 0-lactose goat milk powder are mixed in proportion, and a proper amount of anhydrous ethanol is sprayed to wet and stir the materials to form a uniform wet state;

[0021] b) The active ingredient group: the non-denatured type II collagen is treated by using a nano-embedding technology, microcapsules are prepared, and the embedding rate is controlled to be greater than or equal to 92% and the particle size is 5-20 μm;

[0022] Step two, auxiliary material low-temperature baking: the auxiliary material mixture prepared in step one a) is placed in a baking device and baked at 60±2 ℃ for 6-8 hours;

[0023] Step three, cooling and crushing: the baked auxiliary material mixture is naturally cooled to room temperature, crushed by using a universal crusher, and then sieved through an 80-mesh sieve;

[0024] Step four, low-temperature mixing: the embedded active ingredient in step one b), the sodium carboxymethyl starch, the cross-linked povidone, and the crushed auxiliary material in step three are placed in a low-temperature mixing machine and mixed at a temperature less than or equal to 30 ℃ for 15-20 minutes, and the uniformity of mixing is greater than or equal to 95%;

[0025] Step five, granulation and standing: anhydrous ethanol is slowly sprayed to wet and granulate the mixture in step four, the particle size is controlled to be 100-120 mesh by using a swing granulator, and the prepared granules are placed in a constant-temperature and constant-humidity environment for 11-12.5 hours;

[0026] Step six, low-temperature tabletting: the granules after standing are mixed with magnesium stearate, and then placed in a tabletting machine for tabletting.

[0027] Step seven, finished product inspection: take qualified tablet finished product to carry out index detection, after inspection qualified, adopt aluminum foil independent packaging, enter warehouse storage

[0028] Optionally, the purity of the anhydrous ethanol in step one is ≥99.5%, and the addition amount of the anhydrous ethanol in the auxiliary material group is 10%-15% of the total weight of the auxiliary material.

[0029] The particle size of the microcapsule prepared by nano-embedding in step one b) is 5-20 μm.

[0030] Optionally, the auxiliary material mixture is cooled to 20-25 DEG C in step three, and then is crushed, and the undersize rate of the crushed material is ≥98%.

[0031] The constant temperature and humidity environment parameters in step five are temperature 23-27 DEG C and relative humidity 40%-50%.

[0032] Optionally, the environment temperature for low-temperature tabletting in step six is 35-40 DEG C, and the tablet hardness is controlled to be 170-190 N.

[0033] The temperature fluctuation range of the distilled water in step seven is 25±1 DEG C.

[0034] Compared with the prior art, the application has at least one of the following beneficial technical effects:

[0035] The non-denatured type II collagen protein is pretreated by the nano-embedding technology, the whole process ≤60 DEG C low-temperature processing technology and the anhydrous ethanol wet granulation technology are matched, the temperature, humidity and enzymatic environment are effectively isolated, the natural triple helix structure of UC-II is avoided from being destroyed, the active ingredient retention rate is ≥95%, the inactivation rate of more than 40% in the prior art is greatly optimized; meanwhile, the active retention rate is ≥90% in the 40 DEG C accelerated test for 3 months, the storage stability at room temperature is significantly improved, and the problem that the active ingredient of the traditional product is easily hydrolyzed and attenuated is completely solved.

[0036] The application adopts the composite disintegration system of sodium carboxymethyl starch and cross-linked povidone in a synergistic ratio, combines with 100-120 mesh precise particle grading control, and matches with 8-10 MPa tabletting parameter balance design, so that even if the tablet hardness reaches 170-190 N, the transportation breakage rate is <0.5%, 25 DEG C water is achieved within 1.5-3.0 minutes, the disintegration time of more than 15 minutes in the prior art is greatly shortened, the peak time of the effective component is shortened by 50%, the peak concentration is increased by 30%, the bioavailability is 85.0%-90.0%, which is far higher than the absorption level of ≤60% in the prior art, and the component waste is reduced.

[0037] The application constructs a double-action path of immune regulation and nutritional supplement of UC-Ⅱ, chondroitin sulfate sodium and sodium hyaluronate, breaks through the limitation of single nutritional supplement of traditional products, can intervene in joint problems from two directions of inflammation regulation and cartilage maintenance; the superposition of the rapid disintegration and dissolution characteristics of the dispersible tablets and the high activity of UC-Ⅱ synergistically enhance each other, and the effect time is significantly shortened; the UC-Ⅱ is selected from chicken breast cartilage, and ingredients such as chondroitin sulfate sodium and MSM are removed, so that the allergic reaction rate of pets is reduced, and the pets with sensitive gastrointestinal are adapted; the dispersible tablet supports multiple feeding modes such as direct feeding, grain feeding, water feeding and the like, solves the disadvantages of traditional tablets needing to be chewed and swallowed, and is suitable for young pets and pets with swallowing dysfunction, and improves the feeding compliance;

[0038] The dispersible tablet process parameters are clear and controllable, the composite disintegration system is compatible with the characteristics of various raw materials in the low-temperature processing technology, the tablet is hard but not brittle, and the tablet is scattered but not broken, which not only guarantees the production efficiency of large-scale production, but also meets the pet food hygiene standards; the flavor improving ingredients in the formula synergize with the low allergen raw materials, improve the palatability, adapt to pets with special physiological conditions such as lactose intolerance, and balance the efficacy, safety and convenience of use, and meet the fine needs of pet joint maintenance;

[0039] In summary, the application protects the structure of the core active ingredient by means of nano-embedding and whole-process low-temperature technology, optimizes the performance of the dispersible tablet through the composite disintegration system, constructs a double joint maintenance path of immune regulation and nutritional supplement, removes the allergen ingredients to improve the safety, supports multiple feeding modes, greatly improves the palatability and adaptability, and effectively solves many problems of traditional pet joint supplements. DETAILED DESCRIPTION

[0040] The embodiments of the application are described below through specific examples, and those skilled in the art can easily understand other advantages and effects of the application from the disclosure. The application can also be implemented or applied by different specific embodiments, and various modifications or changes can be made to the details in the specification without departing from the spirit of the application. It should be noted that the following examples and features in the examples can be combined with each other without conflict. Example 1

[0041] The embodiment provides a high-activity non-denatured type Ⅱ collagen pet joint dispersible tablet, which is composed of the following raw materials in percentage by weight: non-denatured type Ⅱ collagen 5.5%, chondroitin sulfate sodium 5.0%, green-lipped mussel powder 5.0%, sodium hyaluronate 1.0%, microcrystalline cellulose 35.0%, carboxymethyl starch sodium 15.0%, sweet potato starch 18.0%, cross-linked polyvinylpyrrolidone 5.0%, enzymatic chicken liver powder 8.0%, yeast extract 3.0%, 0 lactose sheep milk powder 2.5%, and magnesium stearate 0.5%.

[0042] Raw material index:

[0043] Non-denatured type II collagen: from chicken sternal cartilage tissue, purity 98.8%, microcapsule particle size 10-12 μm after nano-embedding treatment, embedding rate 93.5%;

[0044] Sodium chondroitin sulfate: molecular weight 6500 Da, purity 96%; green-lipped mussel powder: protein content 65.0%, moisture content 7.0%; sodium hyaluronate: molecular weight 1.6*10 6 Da;

[0045] Enzymatically hydrolyzed chicken liver powder: protein content 72.5%, enzymatic hydrolysis rate 87.5%; yeast extract: amino acid nitrogen 3.0%; 0-lactose goat milk powder: lactose content 0.3%, protein content 30.0%;

[0046] Microcrystalline cellulose: particle size 90 mesh, fluidity 20 cm / 100 s; sodium carboxymethyl starch: water absorption expansion rate 350%, degree of substitution 0.65; cross-linked povidone: specific surface area 1.35 m² / g; sweet potato starch: moisture content 10.0%.

[0047] Preparation method:

[0048] Step one, raw material grouping treatment: a) adjuvant group: mix the above-mentioned specifications of microcrystalline cellulose, sweet potato starch, and enzymatically hydrolyzed chicken liver powder, yeast extract, and 0-lactose goat milk powder according to the proportion, add 12% of the total weight of adjuvants, 99.8% of anhydrous ethanol with a purity of 99.8%, spray wet and stir to make the material form a uniform wet state that can be formed into a ball and scattered by a light touch;

[0049] b) active ingredient group: non-denatured type II collagen is treated by nano-embedding technology to prepare microcapsules, with an embedding rate of 93.5% and a microcapsule particle size of 10-12 μm.

[0050] Step two, adjuvant low-temperature baking: place the adjuvant mixture prepared in step one a) in a baking device and bake at 60±2℃ for 7 hours.

[0051] Step three, cooling and crushing: cool the baked adjuvant mixture to 23℃ naturally, crush it with a universal crusher, and sieve it through an 80-mesh sieve after crushing, with a sieve undersize rate of 98.5%.

[0052] Step four, low-temperature mixing: place the embedded active ingredient of step one b), sodium carboxymethyl starch, cross-linked povidone, and the crushed adjuvant of step three in a low-temperature mixer and mix at 28℃ for 17 minutes, with a mixing uniformity of 96%.

[0053] Step five, granulation and standing: slowly add anhydrous ethanol to the mixture of step four to spray wet granulation, control the particle size of 110 mesh by swing granulator; place the prepared granules in a constant temperature and humidity environment with a temperature of 25°C and a relative humidity of 45% for 12 hours.

[0054] Step six, low temperature tabletting: add magnesium stearate to the standing granules, mix for 4 minutes, then place in a tablet machine and tablet at 38°C, control the tablet hardness at 180N.

[0055] Step seven, finished product inspection and storage: take 3 tablets of finished product and place in distilled water at 25±1°C to test the disintegration time, at the same time test the active ingredient content, microbial limit and other indicators; after passing the test, package with aluminum foil, store in a cool and dry place.

[0056] Finished product core performance:

[0057] The disintegration time in water at 25°C is 2.2 minutes, the non-denatured type II collagen activity retention rate is 95.8%, the bioavailability is 88.6%, the tablet hardness is 180N, and the mixing uniformity is 96%, completely meeting the requirements of the claims and related test standards. Example 2

[0058] This example proposes a high-activity non-denatured type II collagen pet joint dispersible tablet, which is composed of the following raw materials in weight percentage: non-denatured type II collagen 4.0%, sodium chondroitin sulfate 4.0%, green-lipped mussel powder 4.0%, sodium hyaluronate 0.5%, microcrystalline cellulose 30.0%, carboxymethyl starch sodium 12.0%, sweet potato starch 15.0%, cross-linked povidone 4.0%, enzymatic chicken liver powder 6.0%, yeast extract 2.0%, 0-lactose goat milk powder 1.5%, and magnesium stearate 0.3%.

[0059] Raw material indicators:

[0060] Non-denatured type II collagen: derived from chicken breast cartilage tissue, purity 98.0%, nano-embedded microcapsule particle size 8-10μm, embedding rate 92.0%;

[0061] Sodium chondroitin sulfate: molecular weight 4000Da, purity 95%; green-lipped mussel powder: protein content 60.0%, moisture content 8.0%; sodium hyaluronate: molecular weight 1.0*10 6 Da;

[0062] Enzymatic chicken liver powder: protein content 70.0%, enzymatic rate 85.0%; yeast extract: amino acid nitrogen 2.8%; 0-lactose goat milk powder: lactose content 0.4%, protein content 28.0%;

[0063] Microcrystalline cellulose: particle size 80 mesh, flowability 18 cm / 100 s; sodium carboxymethyl starch: water absorption expansion rate 300%, degree of substitution 0.5; crosslinked povidone: specific surface area 1.2 m 2 / g; sweet potato starch: moisture content 11.0%.

[0064] Preparation method:

[0065] Step one, raw material grouping processing: a) excipient group: mix the above-mentioned specifications of raw materials according to the proportion, add 10% of the total weight of excipients, 99.5% of pure anhydrous ethanol to spray wet and stir, so that the material forms a uniform wet state;

[0066] b) active ingredient group: non-denatured type II collagen is treated by nano-embedding to prepare microcapsules, with an embedding rate of 92.0% and a microcapsule particle size of 8-10 μm.

[0067] Step two, low-temperature baking of excipients: bake the excipient mixture at 58°C for 8 hours.

[0068] Step three, cooling and crushing: cool the baked excipients to 20°C, crush and pass through an 80-mesh sieve, with a sieve undersize rate of 98.0%.

[0069] Step four, low-temperature mixing: mix the embedded active ingredients and other raw materials with the crushed excipients at 25°C for 15 minutes, with a uniform mixing degree of 95%.

[0070] Step five, granulation and standing: control the particle size of the granules to 100 mesh, and place them in an environment with a temperature of 23°C and a relative humidity of 40% for 11 hours.

[0071] Step six, low-temperature tabletting: add magnesium stearate and mix for 3 minutes, then tablet at 35°C, with a tablet hardness of 170N.

[0072] Step seven, finished product inspection and storage: take the finished product and test it in distilled water at 25±1°C, and after passing the inspection, package it in aluminum foil and store it in the warehouse.

[0073] Core performance of finished product:

[0074] The disintegration time in water at 25°C is 2.8 minutes, the non-denatured type II collagen activity retention rate is 95.1%, the bioavailability is 85.2%, the tablet hardness is 170N, and all the performance indicators meet the requirements of the claims. Example 3

[0075] The embodiment provides a high-activity non-denatured type II collagen pet joint dispersible tablet, which is prepared from the following raw materials in percentage by weight: non-denatured type II collagen 7.0%, chondroitin sulfate sodium 6.0%, green-lip mussel powder 6.0%, hyaluronic acid sodium 1.5%, microcrystalline cellulose 40.0%, carboxymethyl starch sodium 18.0%, sweet potato starch 22.0%, cross-linked povidone 6.0%, enzymatic chicken liver powder 10.0%, yeast extract 4.0%, 0-lactose goat milk powder 3.5% and magnesium stearate 0.7%.

[0076] Raw material indexes:

[0077] The non-denatured type II collagen is derived from chicken breast cartilage tissue, has a purity of 99.5%, a microcapsule particle size of 13-15 μm after nano-embedding and an embedding rate of 95.0%.

[0078] The chondroitin sulfate sodium has a molecular weight of 9000 Da and a purity of 97%; the green-lip mussel powder has a protein content of 70.0% and a moisture content of 6.0%; the hyaluronic acid sodium has a molecular weight of 2.2*10 6 Da;

[0079] The enzymatic chicken liver powder has a protein content of 75.0% and an enzymolysis rate of 90.0%; the yeast extract has an amino acid nitrogen content of 3.2%; the 0-lactose goat milk powder has a lactose content of 0.45% and a protein content of 32.0%.

[0080] The microcrystalline cellulose has a particle size of 100 meshes and a fluidity of 22 cm / 100 s; the carboxymethyl starch sodium has a water absorption expansion rate of 400% and a degree of substitution of 0.8; the cross-linked povidone has a specific surface area of 1.5 m² / g; and the sweet potato starch has a moisture content of 11.8%.

[0081] Preparation method:

[0082] Step one, raw material grouping treatment: a) auxiliary material group: the above-mentioned raw materials are mixed according to the proportion, 15% of the total weight of the auxiliary material is added, 99.9% of anhydrous ethanol is sprayed to wet and stir, so that the material forms a uniform wet state;

[0083] b) active ingredient group: the non-denatured type II collagen is nano-embedded to prepare microcapsules, the embedding rate is 95.0%, and the microcapsule particle size is 13-15 μm.

[0084] Step two, auxiliary material low-temperature baking: the auxiliary material mixture is baked at 62 ℃ for 6 hours.

[0085] Step three, cooling and crushing: the baked auxiliary material is cooled to 25 ℃, crushed and then sieved through a 80-mesh sieve, and the sieve undersize rate is 99.0%.

[0086] Step four, low-temperature mixing: the embedded active ingredient and other raw materials are mixed with the crushed auxiliary material at 30 ℃ for 20 minutes, and the mixing uniformity is 97%.

[0087] Step five, granulation standing: control the particle size of the granules 120 mesh, placed in the temperature of 27 ℃, relative humidity 50% environment balance 12.5 hours.

[0088] Step six, low temperature tabletting: add magnesium stearate mixed 5 minutes, 40 ℃ tabletting, control the hardness of the tablets 190 N.

[0089] Step seven, finished product inspection and storage: take the finished product placed in 25 ± 1 ℃ distilled water detection, all indicators are qualified, aluminum foil independent packaging, into the warehouse storage.

[0090] The optimal ratio of the dosage form performance, safety and palatability, and stability data in this embodiment (Example 1) were tested, and the following data table was obtained:

[0091] Table 1 Dosage form performance test data of Example 1

[0092]

[0093] Table 2 Safety and palatability test data of Example 1

[0094]

[0095] Table 3 Stability test data of Example 1

[0096]

[0097] Comparative example (ordinary chondroitin chewable tablets)

[0098] Raw material formula: glucosamine 20.0%, chondroitin sulfate sodium 15.0%, microcrystalline cellulose 30.0%, corn starch 25.0%, magnesium stearate 2.0%, flavor 3.0%, sucrose 5.0%.

[0099] Raw material index: glucosamine: from seafood raw materials (shrimp and crab shells), purity 90.0%; chondroitin sulfate sodium: molecular weight 3000-5000 Da, purity 90.0%;

[0100] Microcrystalline cellulose: particle size 60-80 mesh, flowability 15-17 cm / 100 s; corn starch: moisture content 13.0%;

[0101] Flavor: artificial synthetic pet flavor, sucrose: food grade white sugar, no low sensitivity design.

[0102] Preparation method:

[0103] Step one, raw material mixing: mix glucosamine, chondroitin sulfate sodium, microcrystalline cellulose, corn starch, sucrose according to the proportion, add flavor and stir evenly to form a mixture;

[0104] Step two, dry tabletting: no embedding, low-temperature baking, granulation standing process, directly mix the mixture with magnesium stearate for 3 minutes, and press the tablet under the condition of 85 DEG C and 12 MPa pressure, control the tablet hardness to be 120±20 N;

[0105] Step three, product inspection and storage: take the finished product to detect the appearance and content uniformity, and after passing the test, use ordinary plastic packaging and store in a normal temperature environment.

[0106] The core performance of the products of example 1, example 2 and example 3 and the comparative example is detected, and the following data table is obtained:

[0107] Table 4 Comparison data table of core indicators of the inventive examples and the comparative example

[0108]

[0109]

[0110] The active ingredient retention rate of the inventive examples is all above 95%, and the highest is 96.2%, which is much higher than 58.3% of the comparative example; the bioavailability is also stable above 85%, which is significantly improved compared with 56.7% of the comparative example, effectively reduces the waste of ingredients, and ensures the actual efficacy of the product.

[0111] The dosage form performance advantage is outstanding, the disintegration time of the inventive product in water at 25 DEG C is all less than or equal to 3 minutes, which is increased by more than 80% compared with 18.5 minutes of the comparative example, and the tablet hardness is maintained at 170-190 N, which takes into account the rapid disintegration and structural stability, and the transportation damage rate is less than 0.5%, which is greatly reduced compared with 16.2% of the comparative example, and the storage stability of the product is improved.

[0112] The safety and adaptability are significantly optimized, the incidence of allergic reaction of the inventive product is 0.01%, which solves the pain point of 9.2% of the comparative example; the acceptance rate of the product for pets with dysphagia is above 98%, which is much higher than 28% of the comparative example, and the product is suitable for pets of all ages, and has no adverse reactions in the gastrointestinal tract.

[0113] The joint maintenance effect and stability are better, the joint pain relief rate of the inventive product is above 85% in 28 days, and the lameness improvement score is close to 0, which is significantly better than the comparative example; the active retention rate is still above 88.5% after 12 months of room temperature storage, which is greatly improved compared with the active retention rate of 68.5% after 6 months of storage of the comparative example.

[0114] The above specific embodiments are only several optional embodiments of the present application, based on the technical solutions of the present application and the related inspiration of the above embodiments, those skilled in the art can make various alternative improvements and combinations on the above specific embodiments.

Claims

1. A high activity non-denatured type II collagen pet joint dispersible tablet, characterized in that, It is composed of the following raw materials in percentage by weight: non-denatured type II collagen 4.0%-7.0%, chondroitin sulfate sodium 4.0%-6.0%, green-lipped mussel powder 4.0%-6.0%, hyaluronic acid sodium 0.5%-1.5%, microcrystalline cellulose 30%-40%, sodium carboxymethyl starch 12%-18%, sweet potato starch 15%-22%, cross-linked povidone 4.0%-6.0%, enzymatic chicken liver powder 6.0%-10.0%, yeast extract 2.0%-4.0%, 0-lactose sheep milk powder 1.5%-3.5%, and magnesium stearate 0.3%-0.7%.

2. The high activity non-denatured type II collagen pet joint dispersible tablet according to claim 1, characterized in that, The non-denatured type II collagen is chicken breast cartilage tissue, and the purity of the non-denatured type II collagen is 98.0%-99.5%. The nano-embedded microcapsule has a particle size of 8-15 μm and an embedding rate of 92.0%-95.0%. The chondroitin sulfate sodium has a molecular weight of 4000-9000 Da and a purity of ≥95%. The green-lipped mussel powder has a protein content of 60.0%-70.0% and a water content of ≤6.0%-8.0%. Sodium hyaluronate has a molecular weight of 1.0 x 10 6 -2.2 x 10 6 Da.

3. The high activity non-denatured type II collagen pet joint dispersible tablet according to claim 1, characterized in that, The enzymatic chicken liver powder has a protein content of 70.0%-75.0% and an enzymatic rate of 85.0%-90.0%. The yeast extract has an amino acid nitrogen content of 2.8%-3.2%, the 0-lactose sheep milk powder has a lactose content of <0.5%, and the protein content is 28.0%-32.0%.

4. The high activity non-denatured type II collagen pet joint dispersible tablet according to claim 1, characterized in that, The microcrystalline cellulose has a particle size of 80-100 mesh and a fluidity of 18-22 cm / 100 s. The sodium carboxymethyl starch has a water absorption expansion rate of 300%-400% and a degree of substitution of 0.5-0.

8. The cross-linked povidone has a specific surface area of 1.2-1.5 m² / g. The sweet potato starch has a water content of ≤12.0%.

5. A process for the preparation of the high active non-denatured type II collagen pet joint dispersible tablet according to any one of claims 1-4, characterized in that, The method comprises the following steps: Step one, grouping and processing of raw materials: a) The auxiliary material group: mix the microcrystalline cellulose, sweet potato starch, enzymatic chicken liver powder, yeast extract, and 0-lactose sheep milk powder in proportion, add an appropriate amount of anhydrous ethanol to spray and stir the materials to make them uniformly wet; b) The active ingredient group: process the non-denatured type II collagen using nano-embedding technology to prepare microcapsules and control the embedding rate to be ≥92% and the particle size to be 5-20 μm; Step two, low-temperature baking of auxiliary materials: place the auxiliary material mixture prepared in step one a) in a baking equipment and bake at 60±2℃ for 6-8 hours; Step three, cooling and crushing: cool the baked auxiliary material mixture to room temperature naturally, crush it using a universal crusher, and sieve the crushed material through an 80-mesh sieve; Step four, low-temperature mixing: place the embedded active ingredient, sodium carboxymethyl starch, cross-linked povidone, and the crushed auxiliary material of step three in a low-temperature mixing machine, mix them at ≤30℃ for 15-20 minutes, and control the mixing uniformity to be ≥95%; Step five, granulation and standing: slowly add anhydrous ethanol to the mixture of step four to spray and granulate, control the particle size of the granules to be 100-120 mesh using a swing granulator, and place the prepared granules in a constant-temperature and constant-humidity environment for 11-12.5 hours; Step six, low-temperature tabletting: add magnesium stearate to the granules after standing, mix them, and then place them in a tablet press to make tablets. Step seven, finished product inspection: take qualified tablet finished product for index detection, test qualified, use aluminum foil independent packaging, warehouse storage.

6. The method for preparing a highly active, non-denatured type II collagen pet joint dispersible tablet according to claim 5, characterized in that, The purity of the anhydrous ethanol in step one is ≥99.5%, and the anhydrous ethanol in the auxiliary material group is added in an amount of 10%-15% of the total weight of the auxiliary material; The microcapsule particle size prepared by nano-embedding in step one b) is 5-20 μm.

7. The method for preparing a highly active, non-denatured type II collagen pet joint dispersible tablet according to claim 5, characterized in that, The auxiliary material mixture is cooled to 20-25℃ in step three, and then is pulverized, and the sieve undersize rate of the pulverized material is ≥98%; The constant temperature and humidity environment parameters in step five are temperature 23-27℃ and relative humidity 40%-50%.

8. The method for preparing a highly active, non-denatured type II collagen pet joint dispersible tablet according to claim 5, characterized in that, The environment temperature for low-temperature tabletting in step six is 35-40℃, and the tablet hardness is controlled to be 170-190 N; The distillation water temperature fluctuation range in step seven is 25±1℃.

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