CN112715944A - Amino sugar composite functional formula, tablet containing amino sugar composite functional formula and preparation method - Google Patents

Amino sugar composite functional formula, tablet containing amino sugar composite functional formula and preparation method Download PDF

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CN112715944A
CN112715944A CN202011599893.8A CN202011599893A CN112715944A CN 112715944 A CN112715944 A CN 112715944A CN 202011599893 A CN202011599893 A CN 202011599893A CN 112715944 A CN112715944 A CN 112715944A
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extract
mixture
glucosamine
povidone
glucosamine hydrochloride
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陈洋
张国栋
贺庆
夏旭东
张兴
张勇
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IVC Nutrition Corp
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IVC Nutrition Corp
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    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
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    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
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    • A23P—SHAPING OR WORKING OF FOODSTUFFS, NOT FULLY COVERED BY A SINGLE OTHER SUBCLASS
    • A23P10/00—Shaping or working of foodstuffs characterised by the products
    • A23P10/20—Agglomerating; Granulating; Tabletting
    • A23P10/28—Tabletting; Making food bars by compression of a dry powdered mixture
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
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Abstract

The invention discloses an ammonia sugar compound functional ingredient distribution formula, a tablet containing the same and a preparation method thereof, wherein the ammonia sugar compound functional ingredient distribution formula comprises the following components in percentage by weight: 30-65% of D-glucosamine hydrochloride turmeric extract particles; 5-30% of chondroitin sulfate sodium; 1-20% of frankincense extract particles; 2-20% of horse chestnut extract; 0.2-8% of black pepper extract; 0.5-10% of vitamin C; 8-20% of microcrystalline cellulose; 0-2% of croscarmellose sodium; 0 to 2.5 percent of silicon dioxide; 0-2.5% of crospovidone; 0.2-2% of magnesium stearate; 4-10% of coating premix. The invention adopts a compound of Chinese and western medicines, selects the components and the contents, greatly enhances the bioavailability by utilizing the direct synergistic action of the components, improves the enhancement effect on the aspects of bone density and immunity, and particularly plays a vital auxiliary role in relieving inflammation by utilizing the components of curcumin and piperine.

Description

Amino sugar composite functional formula, tablet containing amino sugar composite functional formula and preparation method
Technical Field
The invention belongs to the technical field of food, and particularly relates to an ammonia-sugar composite functional formula, a tablet containing the same and a preparation method.
Background
The osteoarthropathy is used as a refractory disease and breaks down countless patients, and the osteoarthropathy is prevented and treated inevitably. Glucosamine and chondroitin sulfate are used as dietary supplements with wide sources, and have the effects of preventing and treating osteoarthropathy of middle-aged and elderly people and some special people. Glucosamine can reduce the concentration of proinflammatory transcription factors, enhance the toughness of specific parts of cartilage, and prevent collagen denaturation by inhibiting the activity of hydrolytic enzymes and reducing lipid and protein oxidation. Glucosamine can improve the metabolic function and nutrient absorption of bone and cartilage tissues by stimulating the biochemical synthesis of mucopolysaccharide and increasing the uptake of bone calcium, can also improve and enhance the viscosity of synovial fluid, is also a basic substance for proteoglycan synthesis, can specifically act on articular cartilage, recover the normal metabolic function of chondrocytes, stimulate the production of proteoglycans with normal polymer structures by chondrocytes, and can also inhibit the activity of enzymes which damage cartilage, such as collagenase and phospholipase A2.
Chondroitin sulfate functions by inhibiting the activity of the mitogen-activated protein kinase p38MAPK and the signal-regulated kinase ERK1/2, reducing nuclear translocation of nuclear transcription factor kappa B (NF-kappa B), reducing the synthesis of proteolytic enzymes (matrix metalloproteinases-3, MMP-3), MMP-9, MMP-13, cathepsin B, etc.), inflammation-inducing enzymes (phospholipase a2, cyclooxygenase-2, nitric oxide synthase-2), and proinflammatory cytokines (interleukin-1 β). The combination of glucosamine and chondroitin sulfate can promote the synthesis of type II collagen in human articular chondrocytes, reduce the death of the chondrocytes and keep the balance of anabolism and catabolism of cartilage extracellular matrix. Glucosamine and chondroitin sulfate protect articular chondrocytes through the above-mentioned series of action mechanisms.
The prevention of osteoarthropathy is important in daily life, and if glucosamine and chondroitin sulfate can be matched to prepare food by the time of three meals a day and the medium of food, the aims of strengthening bones and preventing osteoarthropathy can be achieved.
Glucosamine as a drug has many disadvantages such as high hygroscopicity, high susceptibility to oxidative discoloration of the amino group, and high requirement for the formulation of glucosamine, such as the need for coating of tablets, filling of ampoules, sealing of capsule shells with capsules, and the need for moisture and oxygen resistance. In addition, most commercially available glucosamine products have low content of effective drugs, poor stability and low bioavailability, and the products aiming at osteoarthritis or bone injury or osteoporosis in the current domestic and foreign markets have various types and uneven quality, and the existing dietary supplements in the market have the problems of single nutrient component, unreasonable composition and matching proportion or unreasonable dosage and the like, so that various functional components cannot be well absorbed and utilized in the human body, and the ideal repairing and treating effects cannot be achieved.
Therefore, the development and research of novel glucosamine chondroitin sulfate products for replacing the existing glucosamine and chondroitin sulfate medicines have great significance for strengthening bones and preventing osteoarticular diseases.
Disclosure of Invention
The invention aims to provide an ammonia-sugar compound functional formula, a tablet containing the same and a preparation method, wherein the formula has better effects on diminishing inflammation, increasing bone density and enhancing immunity.
In order to achieve the above object, according to one aspect of the present invention, there is provided an amino sugar complex functional formulation comprising the following components in percentage by weight: 30-65% of D-glucosamine hydrochloride turmeric extract particles; 5-30% of chondroitin sulfate sodium; 1-20% of frankincense extract particles; 2-20% of horse chestnut extract; 0.2-8% of black pepper extract; 0.5-10% of vitamin C; 8-20% of microcrystalline cellulose; 0-2% of croscarmellose sodium; 0 to 2.5 percent of silicon dioxide; 0-2.5% of crospovidone; 0.2-2% of magnesium stearate; 4-10% of coating premix.
According to the invention, the ammonia sugar compound functional formula comprises the following components in percentage by weight: 40-50% of glucosamine hydrochloride turmeric extract particles; 10-15% of chondroitin sulfate sodium; 5-12% of frankincense extract particles; 6.5-13% of horse chestnut extract; 0.5-5% of black pepper extract; 1-6% of vitamin C; 12-18% of microcrystalline cellulose; 0.5 to 1.5 percent of croscarmellose sodium; 1-2.2% of silicon dioxide; 1.2 to 2.5 percent of crospovidone; 0.5-1% of magnesium stearate; 4.5 to 7 percent of coating premix.
According to the invention, the glucosamine hydrochloride turmeric extract particles comprise the components of D-glucosamine hydrochloride, turmeric extract, povidone K30, povidone K90. Preferably, the composition of the glucosamine hydrochloride turmeric extract particles comprises 77.6 wt% D-glucosamine hydrochloride, 20 wt% turmeric extract, 2 wt% povidone K30 and 0.4 wt% povidone K90, in weight percent.
According to the present invention, the components of the boswellia extract particles comprise boswellia extract, calcium carbonate and hypromellose. Preferably, the components of the frankincense extract particles comprise 52 wt% of frankincense extract, 47 wt% of calcium carbonate and 1 wt% of hypromellose in percentage by weight.
According to another aspect of the invention, an ammonia-sugar complex functional tablet is also provided, which contains any one of the ammonia-sugar complex functional formulas.
According to a further aspect of the present invention, there is also provided a process for the preparation of a tablet comprising any one of the above described amino sugar complex functional formulations, comprising the steps of: s1, mixing D-glucosamine hydrochloride, the turmeric extract and povidone K30 to form a mixture A, mixing povidone K90 with water to prepare 5% serous fluid, mixing the mixture A into the serous fluid, fully dissolving the mixture A until the mixture A is clear and transparent, putting the obtained mixed material into a wet granulator, and uniformly stirring the mixture A and the serous fluid to obtain glucosamine hydrochloride turmeric extract particles; s2, mixing the frankincense extract and calcium carbonate to obtain a mixture B, preparing 1% slurry by using a proper amount of water and hydroxypropyl methylcellulose, mixing the mixture B into the slurry, fully dissolving the mixture B until the mixture is clear and transparent, putting the obtained mixed material into a wet granulator, uniformly stirring, and carrying out wet granulation to obtain frankincense extract particles; s3, mixing the glucosamine hydrochloride curcuma extract particles and the frankincense extract particles with sodium chondroitin sulfate, horse chestnut extract, black pepper extract, vitamin C, microcrystalline cellulose, croscarmellose sodium, silicon dioxide, crospovidone and magnesium stearate, and pressing into tablets; s4, preparing a coating premix into a solution with the concentration of 20%, and coating the compressed tablets obtained in the step S3 to obtain the tablets.
According to the present invention, D-glucosamine hydrochloride at 77.6 wt%, turmeric extract at 20 wt%, and povidone K30 at 2 wt% are mixed in the step S1. Preferably, 0.4 wt% povidone K90 is mixed with water to make a slurry with a concentration of 5%. Preferably, the boswellia carterii extract is mixed with 47 wt% of calcium carbonate and 1 wt% of hypromellose in step S2.
According to another aspect of the invention, the invention also provides powder which contains the amino sugar complex functional formula.
According to another aspect of the invention, a capsule is also provided, which contains the amino sugar complex functional formula.
According to still another aspect of the invention, the invention also provides a health care product which contains any one of the ammonia sugar complex functional formulas.
The invention has the beneficial effects that:
1) the compound preparation is prepared from Chinese and western medicine raw materials such as glucosamine hydrochloride, sodium chondroitin sulfate, frankincense extract, black pepper extract, horse chestnut extract, turmeric extract, vitamin C and the like, the mixture ratio of the raw material components in the compound preparation is matched and selected, and the synergistic effect of the components is utilized, so that the bioavailability is greatly improved, and the product has better functions in the aspects of diminishing inflammation, resisting bacteria, increasing bone density and enhancing immunity. The curcumin in the curcuma extract and the piperine in the black pepper extract play a vital auxiliary role in relieving inflammation, the effects of the frankincense extract and the horse chestnut extract are utilized, the glucosamine content in the tablet is increased, the nutrition and health care functions are increased, the tablet can be directly chewed for use, the absorption of a human body is not influenced, the dissolution is rapid, the tablet is suitable for patients with dysphagia, and the stability is good.
2) In view of the defect that the frankincense extract is easy to absorb moisture and strong in cohesiveness of the material, the frankincense extract can generate sticking phenomenon when being directly used for tabletting, and the moisture absorption is easy to generate spots on the surface of the tablet along with the time extension, the invention innovates the preparation process of the frankincense extract particles, greatly improves the material characteristics after the frankincense extract is granulated, avoids the sticking phenomenon, delays the generation of the spots in the product placing process, and lays a good foundation for the industrialization of the product.
3) Because the turmeric extract has large dosage and high proportion in the formula, the powder is fine, the materials are fluffy, the sticking phenomenon can occur during tabletting, and the tablet weight is easy to be unstable.
4) The turmeric extract and the active ingredients in the frankincense extract, the horse chestnut extract and the black pepper extract have synergistic effect, and the curative effect of treating osteoarticular diseases is better than glucosamine therapy which uses glucosamine alone, is also better than the therapy which combines the glucosamine and other components, and is better than the mixed therapy which uses glucosamine and chondroitin sulfate. The active ingredients in the prescription can quickly and directly enter the blood circulation of the bone joint part in high quantity and directly enter the bone joint part of a patient, the effect is fast, the raw materials are all natural, the affinity with the human body is high, no substances such as stimulation, anesthesia and hormone are contained, the treatment effect is obvious, and the long-acting effect is realized without rebound.
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FIG. 1 is a graph comparing the effect (neutrophil count) of the inflammation of zebrafish between each experimental group and model control group of the present invention.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention will be described in further detail with reference to the accompanying drawings and embodiments. It should be emphasized that the specific embodiments described herein are merely illustrative of the invention, are some, not all, and therefore do not limit the invention. In addition, the technical features involved in the embodiments of the present invention described below may be combined with each other as long as they do not conflict with each other.
The invention provides an ammonia sugar compound functional ingredient distribution formula, which comprises the following components in percentage by weight: 30-65% of D-glucosamine hydrochloride turmeric extract particles; 5-30% of chondroitin sulfate sodium; 1-20% of frankincense extract particles; 2-20% of horse chestnut extract; 0.2-8% of black pepper extract; 0.5-10% of vitamin C; 8-20% of microcrystalline cellulose; 0-2% of croscarmellose sodium; 0 to 2.5 percent of silicon dioxide; 0-2.5% of crospovidone; 0.2-2% of magnesium stearate; 4-10% of coating premix.
Preferably, the formula comprises the following components in percentage by weight: 30-65% of D-glucosamine hydrochloride turmeric extract particles; 10-15% of chondroitin sulfate sodium; 5-20% of frankincense extract particles; 6.5 to 20 percent of horse chestnut extract; 0.5-8% of black pepper extract; 1-10% of vitamin C; 8-20% of microcrystalline cellulose; 0.5 to 2 percent of croscarmellose sodium; 1-2.2% of silicon dioxide; 1.2 to 2.5 percent of crospovidone; 0.2-2% of magnesium stearate; 4.5 to 10 percent of coating premix.
The invention adopts silicon dioxide as a lubricant and a glidant, has good compressibility, moderate hardness, good mouthfeel, smooth and tidy appearance, uses microcrystalline cellulose and povidone as a binder, uses croscarmellose sodium as a disintegrant, and adds frankincense extract, horse chestnut extract and black pepper extract, thereby not only ensuring that the obtained glucosamine chewable tablet has high active ingredient and rapid dissolution, but also improving the stability and being difficult to deteriorate.
Chondroitin sulfate is a subfamily of glycosaminoglycan, exists in animal cartilage in a large amount, is acidic mucopolysaccharide extracted from animal cartilage, can promote cartilage regeneration, repair and reverse damage, increase joint synovial fluid volume, effectively relieve joint pain and improve joint function. Cartilage is free of blood supply, and its oxygen supply, nutrients and lubrication are from synovial fluid, chondroitin transports oxygen and nutrients to the cartilage and discharges carbon dioxide and waste products. Matrix metalloproteases and proinflammatory cytokines (e.g., interleukin-1) secreted by joint synoviocytes and chondrocytes are important mediators of cartilage destruction, and abnormal expression thereof has an early warning effect on the development of Osteoarthritis (OA). Chondroitin can reduce damage to cartilage matrix and synovial fluid components by inhibiting the activity of degrading enzymes such as protease; by reducing fibrin thrombosis, improving blood circulation in the synovial membrane of joints and subchondral bone; can be used for preventing and treating arthritis by inhibiting cyclooxygenase-2 activity. The constituent glycosaminoglycans need to be highly sulfated, and the supplementation of the chondroitin sulfate moiety can counteract the adverse effects caused by the reduction of the sulfate component in vivo.
Glucosamine is a natural amino monosaccharide, is a main component for synthesizing proteoglycan in a cartilage matrix, can stimulate the growth of chondrocytes and the synthesis of the cartilage matrix, improve the cartilage metabolism, improve the repair capacity of damaged cartilage, relieve the symptoms of OA pain and improve the joint function. The composition has antiinflammatory, analgesic, and disease development delaying effects. The glucosamine hydrochloride has low price and good curative effect, can promote the synthesis of mucopolysaccharide of a human body, improve the viscosity of joint synovial fluid, improve the metabolism of articular cartilage, can effectively relieve the symptoms of KOA at early and middle stages, has stable long-term curative effect and better long-term administration effect.
The frankincense extract contains 60-70% of resin, 27-35% of gum and 3-8% of volatile oil. Can promote blood circulation to relieve pain, and treat pain due to blood stasis, rheumatism, arthralgia, and traumatic blood stasis and swelling. It also has repercussive and granulation promoting effects, and can be used for treating early stage pyocutaneous disease, red swelling and pain.
Horse chestnut extract is commonly used in pharmaceutical cream or cosmetics in the prior art, and the extract is used as a main functional component of the cream in the medicine and has the function of surface activity and moisture retention. The cosmetic can be used as a colloid material to increase the smoothness and softness of skin and delay the aging of skin. The horse chestnut extract is adopted as a key component, and the horse chestnut extract and other main components have synergistic effect, so that the horse chestnut extract is favorable for resisting tissue edema, reducing vascular permeability, preventing water accumulation in tissues and quickly eliminating heavy feeling and pressure caused by local edema, has obvious effects on resisting inflammation, resisting exudation and relieving swelling, can restore normal permeability of capillary vessels and increase venous tension. In addition, the horse chestnut also has the functions of inhibiting collagenase, hyaluronidase, B-glucuronidase and elastase, and can play roles in promoting blood circulation, promoting wound healing, resisting edema, resisting inflammation, resisting exudation and protecting blood vessels in external formulations. Escin is the most important inflammation-reducing component of horse chestnut fruit and is effective in improving the integrity of the vessel wall by filling up tiny gaps and tiny visible gaps of venules and capillaries.
The Curcuma rhizome extract is dried rhizome extract of Curcuma rhizome of Zingiberaceae, and the main bioactive substances are Curcumin (curcin) and turmerone. The curcumin and the volatile oil have good antibacterial effect on Staphylococcus aureus. The Curcuma rhizome extract has effect in inhibiting various fungi; curcumin has significant inhibitory effect on experimental inflammation of mice and rats, has anti-inflammatory effect on rheumatoid arthritis, and has certain curative effect on spermatic cord edema and tenderness.
The fructus Piperis extract is dry near-ripe or ripe fruit extract of Piper nigrum L. of Piperaceae, and containsPiperine (C)17H19NO3) Jiaweialkali (C)17H19NO3) Piperidine [ (CH)2)5NH and piperitone (C)19H21O3N), and the like. The piperine can promote absorption of medicine, enhance medicine effect, and reduce medicine dosage. Has effects in tranquilizing mind, removing toxic materials, relaxing muscles and tendons, promoting blood circulation, warming middle warmer, expelling cold, stimulating appetite, invigorating qi, eliminating phlegm, regulating viscera, and invigorating kidney-qi.
According to the invention, the glucosamine hydrochloride turmeric extract particles comprise the components of D-glucosamine hydrochloride, turmeric extract, povidone K30, povidone K90. Preferably, the glucosamine hydrochloride turmeric extract particles comprise 77.6 wt% D-glucosamine hydrochloride, 20 wt% turmeric extract, 2 wt% povidone K30, and 0.4 wt% povidone K90, in weight percent.
According to the present invention, the components of the boswellia extract particles comprise boswellia extract, calcium carbonate and hypromellose. Preferably, the components of the frankincense extract particles comprise 52 wt% of frankincense extract, 47 wt% of calcium carbonate and 1 wt% of hypromellose in percentage by weight.
According to another aspect of the present invention, there is provided a glucosamine complex functional ingredient separation tablet comprising any one of the aforementioned formulations.
According to another aspect of the present invention, there is provided a method for preparing a tablet containing the above glucosamine complex functional ingredient distribution formula, comprising the steps of:
s1, mixing D-glucosamine hydrochloride, the turmeric extract and povidone K30 to form a mixture A, mixing povidone K90 with water to prepare 5% serous fluid, mixing the mixture A into the serous fluid, fully dissolving the mixture A until the mixture A is clear and transparent, putting the obtained mixed material into a wet granulator, and uniformly stirring the mixture A and the serous fluid to obtain glucosamine hydrochloride turmeric extract particles;
s2, mixing the frankincense extract and calcium carbonate to obtain a mixture B, preparing 1% slurry by using a proper amount of water and hydroxypropyl methylcellulose, mixing the mixture B into the slurry, fully dissolving the mixture B until the mixture is clear and transparent, putting the obtained mixed material into a wet granulator, uniformly stirring, and carrying out wet granulation to obtain frankincense extract particles;
s3, mixing the glucosamine hydrochloride curcuma extract particles and the frankincense extract particles with sodium chondroitin sulfate, horse chestnut extract, black pepper extract, vitamin C, microcrystalline cellulose, croscarmellose sodium, silicon dioxide, crospovidone and magnesium stearate, and pressing into tablets;
s4, preparing a coating premix into a solution with the concentration of 20%, and coating the compressed tablets obtained in the step S3 to obtain the tablets.
Preferably, the D-glucosamine hydrochloride of 77.6 wt%, the turmeric extract of 20 wt%, and the povidone K30 of 2 wt% are mixed in the step S1. Preferably, 0.4 wt% povidone K90 is mixed with water to make a slurry with a concentration of 5%. Preferably, the boswellia carterii extract is mixed with 47 wt% of calcium carbonate and 1 wt% of hypromellose in step S2.
The invention combines the efficacy of Chinese and western medicine components to carry out compatibility of each component medicine, and selects and optimizes the proportion of each component, thereby completing component improvement and product preparation. The health care product prepared by the invention effectively improves osteoarthritis or bone injury or osteoporosis, and simultaneously ensures that the effective components are fully absorbed and utilized in human body.
The technical scheme of the invention is further explained by combining specific examples.
Unless otherwise indicated, the raw materials and reagents used in the following examples are all commercially available products or can be prepared by known methods.
Example 1
The preparation of the glucosamine complex functional ingredient dosage form comprises the following steps:
1) preparing particles of a turmeric extract glucosamine hydrochloride; mixing with 77.6 wt% D-glucosamine hydrochloride, 20 wt% Curcuma rhizome extract, and 2 wt% polyvidone K30 to obtain mixture A. Preparing 5 wt% slurry with 0.4 wt% polyvidone K90 with appropriate amount of water, dissolving mixture A into the slurry completely until clear and transparent, adding the obtained mixture into wet granulator, stirring for 10 min, and mixing to obtain granule of glucosamine hydrochloride and Curcuma rhizome extract.
2) And (3) wet granulation of the frankincense extract: mixing 52 parts by weight of frankincense extract, 47 parts by weight of calcium carbonate and 1 part by weight of hydroxypropyl methylcellulose to obtain a mixture B. Preparing hydroxypropyl methylcellulose into slurry with the concentration of 1 wt% by using a proper amount of water, fully dissolving the mixture B until the mixture B is clear and transparent, putting the obtained mixed material into a wet granulator, stirring for 5 minutes, and uniformly mixing to obtain the frankincense extract particles.
3) Adopting the glucosamine hydrochloride turmeric extract particles prepared in the step 1) and the frankincense extract prepared in the step 2) to perform wet granulation, mixing according to the following component formula, and pressing into tablets:
the turmeric extract particles of glucosamine hydrochloride 975g (65 wt%), sodium chondroitin sulfate 75g (5 wt%), boswellia extract particles 75g (5 wt%), horse chestnut extract 97.5g (6.5 wt%), black pepper extract 7.5g (0.5 wt%), vitamin C15g (1 wt%), microcrystalline cellulose 126g (8.4 wt%), croscarmellose sodium 7.5g (0.5 wt%), silicon dioxide 33g (2.2 wt%), crospovidone 18g (1.2 wt%), magnesium stearate 3g (0.2 wt%).
4) Taking 67.5g (4.5 wt%) of the coating premix, preparing a coating premix solution with the concentration of 20 wt%, and coating the tablets prepared in the step 3).
Example 2
1) Preparation of glucosamine hydrochloride turmeric extract granules: mixing with 77.6 wt% D-glucosamine hydrochloride, 20 wt% Curcuma rhizome extract, and 2 wt% polyvidone K30 to obtain mixture A. Preparing 5 wt% slurry with 0.4 wt% polyvidone K90 with appropriate amount of water, dissolving mixture A into the slurry completely until clear and transparent, adding the obtained mixture into wet granulator, stirring for 10 min, and mixing to obtain granule of glucosamine hydrochloride and Curcuma rhizome extract.
2) And (3) wet granulation of the frankincense extract: mixing 52 parts by weight of frankincense extract, 47 parts by weight of calcium carbonate and 1 part by weight of hydroxypropyl methylcellulose to obtain a mixture B. Preparing hydroxypropyl methylcellulose into slurry with the concentration of 1 wt% by using a proper amount of water, fully dissolving the mixture B until the mixture B is clear and transparent, putting the obtained mixed material into a wet granulator, stirring for 5 minutes, and uniformly mixing to obtain the frankincense extract particles.
3) Adopting the glucosamine hydrochloride turmeric extract particles prepared in the step 1) and the frankincense extract prepared in the step 2) to perform wet granulation, mixing according to the following component formula, and pressing into tablets:
450g (30 wt%) of turmeric extract granules, glucosamine hydrochloride, 150g (10 wt%) of sodium chondroitin sulfate, 300g (20 wt%) of boswellia extract granules, 225g (15 wt%) of horse chestnut extract, 3g (0.2 wt%) of black pepper extract, 75g (5 wt%) of vitamin C, 178.5g (11.9 wt%) of microcrystalline cellulose, 12g (0.8 wt%) of croscarmellose sodium, 18g (1.2 wt%) of silicon dioxide, 15g (1 wt%) of crospovidone, and 9g (0.6 wt%) of magnesium stearate.
4) Taking 64.5g (4.3 wt%) of the coating premix, preparing a coating premix solution with the concentration of 20 wt%, and coating the tablets prepared in the step 3).
The tablets in example 1 (1.6 g/tablet, 2 tablets per day) and the tablets in example 2 (3 times per day, 2 tablets per time, 0.85 g/tablet) were converted to zebrafish concentrations according to clinical dosage as needed, which were 533 and 850ug/ml, respectively.
Making of models
Treating 3dpf transgenic neutrophilic granulocyte fluorescent zebra fish for 1 hour by using a test article and a positive medicament in advance, and then continuously treating for 2 hours by using copper sulfate in a water-soluble mode to establish a zebra fish inflammation model.
Experimental methods
Randomly selecting 3-day (3dpf) transgenic neutrophilic granulocyte fluorescent zebra fish after fertilization into a six-well plate, randomly selecting 30 fish in each well, wherein the volume of each well is 3ml, using fish culture water to dissolve the transgenic neutrophilic granulocyte fluorescent zebra fish in water in advance, treating the tablets in example 1 and the tablets in example 2 and indomethacin for 1 hour, the concentration of the tablets in example 1 is 533ug/ml, the concentration of the tablets in example 2 is 850ug/ml, and the concentration of the indomethacin is 29ug/ml, setting a normal control group (namely the water-treated zebra fish for fish culture) and a model control group, placing the normal control group and the model control group in an incubator at 28 ℃ for culture for 1 hour, and then using copper sulfate to establish a transgenic neutrophilic granulocyte fluorescent zebra fish inflammation model. After the sample is continuously treated for 2 hours, randomly taking 10 zebra fish from each group, observing under a fluorescence microscope, taking a picture and storing the picture; carrying out image analysis by using Nikon advanced image processing software, calculating the number (N) of neutrophils at the inflammatory part of the zebra fish, expressing a statistical processing result by X +/-SE, and respectively evaluating the anti-inflammatory effect of the test sample on the zebra fish with the inflammation induced by the copper sulfate according to the statistical analysis result of the number of the zebra fish inflammatory neutrophils.
Statistical analysis using analysis of variance and Dunnett's T-test showed significant differences with p < 0.05.
Results of the experiment
The comparison of the number (19) of neutrophils at the verification part of the zebra fish in the model control group with that in the normal control group (3) shows that the zebra fish inflammation model induced by the copper sulfate is successful, and the p is less than 0.001. Compared with a model control group (19), the number of neutrophils (11) at the inflammatory part of the indometacin zebrafish at 29 mu g/mL is less than 0.001, the inflammation regression effect is 42.1%, and the indometacin has obvious anti-inflammatory effect on the inflammatory zebrafish.
When the concentration of the tablet in example 1 is 533. mu.g/mL, the inflammation regression effect of the zebrafish in the case of the number of neutrophils (5) at the inflammation site is 73.7% compared with the model control group (19), wherein p is less than 0.001. When the concentration of the tablet in example 2 is 850 mug/mL, the inflammation regression effect of the zebrafish at the inflammation part is 73.7 percent when the number of the neutrophils (5) is compared with that of a model control group (19) and is less than 0.001. The tablets in example 1 and example 2 had an anti-inflammatory effect on zebrafish, and the inflammation regression rate was the same for both clinically equivalent highest doses.
FIG. 1 is a graph of the effect of each experimental protocol on zebrafish inflammation (neutrophil count) compared to a model control: p is less than 0.001.
Therefore, under the condition of the concentration in the experiment, the tablets prepared in the example 1 and the example 2 of the invention have the effects of promoting cartilage regeneration and resisting inflammation, so that the tablets have the anti-inflammatory effect on rheumatoid arthritis and have certain curative effects on relieving spermatic cord edema and tenderness.
The foregoing is only a preferred application of the present invention, and it should be noted that, for those skilled in the art, various modifications and improvements can be made without departing from the technical principle of the present invention, and these modifications and improvements should also be considered as the protection scope of the present invention.

Claims (10)

1. The amino sugar composite functional formula is characterized by comprising the following components in percentage by weight:
Figure FDA0002870990270000011
2. the amino sugar complex functional formulation according to claim 1, comprising the following components in weight percent:
Figure FDA0002870990270000012
Figure FDA0002870990270000021
3. the glucosamine complex functional formulation according to claim 1 or 2, wherein the components of said glucosamine hydrochloride turmeric extract particles comprise D-glucosamine hydrochloride, turmeric extract, povidone K30, povidone K90.
Preferably, the glucosamine hydrochloride turmeric extract particles comprise 77.6 wt% D-glucosamine hydrochloride, 20 wt% turmeric extract, 2 wt% povidone K30, and 0.4 wt% povidone K90, in weight percent.
4. The glucosamine complex functional formulation according to claim 1 or 2, wherein the components of said Boswellia serrata extract particles comprise Boswellia serrata extract, calcium carbonate and hypromellose.
Preferably, the components of the frankincense extract particles comprise 52 wt% of frankincense extract, 47 wt% of calcium carbonate and 1 wt% of hypromellose in percentage by weight.
5. An glucosamine complex functional tablet comprising the glucosamine complex functional formulation according to any one of claims 1 to 4.
6. A process for the preparation of tablets containing the amino sugar complex functional formulation according to any of claims 1 to 4, comprising the following steps:
s1, mixing D-glucosamine hydrochloride, the turmeric extract and povidone K30 to form a mixture A, mixing povidone K90 with water to prepare 5% serous fluid, mixing the mixture A into the serous fluid, fully dissolving the mixture A until the mixture A is clear and transparent, putting the obtained mixed material into a wet granulator, and uniformly stirring the mixture A and the serous fluid to obtain glucosamine hydrochloride turmeric extract particles;
s2, mixing the frankincense extract and calcium carbonate to obtain a mixture B, preparing 1% slurry by using a proper amount of water and hydroxypropyl methylcellulose, mixing the mixture B into the slurry, fully dissolving the mixture B until the mixture is clear and transparent, putting the obtained mixed material into a wet granulator, uniformly stirring, and carrying out wet granulation to obtain frankincense extract particles;
s3, mixing the glucosamine hydrochloride curcuma extract particles and the frankincense extract particles with sodium chondroitin sulfate, horse chestnut extract, black pepper extract, vitamin C, microcrystalline cellulose, croscarmellose sodium, silicon dioxide, crospovidone and magnesium stearate, and pressing into tablets;
s4, preparing a coating premix into a solution with the concentration of 20%, and coating the compressed tablets obtained in the step S3 to obtain the tablets.
7. The method of claim 6, wherein the D-glucosamine hydrochloride in the amount of 77.6 wt%, the Curcuma longa extract in the amount of 20 wt%, and the povidone K30 in the amount of 2 wt% are mixed in the step S1.
Preferably, 0.4 wt% povidone K90 is mixed with water to make a slurry with a concentration of 5%.
Preferably, the boswellia carterii extract is mixed with 47 wt% of calcium carbonate and 1 wt% of hypromellose in step S2.
8. A powder comprising the amino sugar complex functional formulation of any one of claims 1 to 4.
9. A capsule comprising the amino sugar complex functional formulation according to any one of claims 1 to 4.
10. A health product comprising the amino sugar complex functional formulation according to any one of claims 1 to 4.
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