CN105770850A - Health care product for adjuvant treatment of osteoarticular diseases and preparation method of health care product - Google Patents

Health care product for adjuvant treatment of osteoarticular diseases and preparation method of health care product Download PDF

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CN105770850A
CN105770850A CN201610262529.XA CN201610262529A CN105770850A CN 105770850 A CN105770850 A CN 105770850A CN 201610262529 A CN201610262529 A CN 201610262529A CN 105770850 A CN105770850 A CN 105770850A
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parts
preparation
joint disease
health product
health care
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钱志诚
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Nanjing Bancom Biotechnology Co Ltd
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Nanjing Bancom Biotechnology Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K38/01Hydrolysed proteins; Derivatives thereof
    • A61K38/012Hydrolysed proteins; Derivatives thereof from animals
    • A61K38/014Hydrolysed proteins; Derivatives thereof from animals from connective tissue peptides, e.g. gelatin, collagen
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7008Compounds having an amino group directly attached to a carbon atom of the saccharide radical, e.g. D-galactosamine, ranimustine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
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    • A61K31/715Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/737Sulfated polysaccharides, e.g. chondroitin sulfate, dermatan sulfate
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K33/06Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • A61K33/10Carbonates; Bicarbonates
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    • A23V2002/00Food compositions, function of food ingredients or processes for food or foodstuffs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/56Materials from animals other than mammals
    • A61K35/60Fish, e.g. seahorses; Fish eggs

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Abstract

The invention relates to the technical field of health care medicine, and particularly discloses a health care product for the adjuvant treatment of osteoarticular diseases and a preparation method of the health care product. The health care product is mainly prepared by the following raw materials in parts by weight: 355 to 395 parts of glucosamine hydrochloride, 110 to 150 parts of chondroitin sulfate, 280 to 320 parts of calcium carbonate, 110 to 150 parts of fish collagen protein, 18 to 22 parts of a disintegrating agent, 36 to 44 parts of a binding agent, and 3 to 7 parts of a lubricant. The health care product is simple in formula, can effectively repair cartilage and improve bone mineral density, meanwhile dredge bone joints to promote blood microcirculation, expedite secretion of joint synovial fluid, eliminate adverse factors, diminish inflammation and alleviate pain, and effectively improve bone joint damage and reduce the problem of joint pain, is stable in product quality, convenient to take, safe and effective, does not have toxic and side effects, and can be taken for a long time. The preparation method is simple to operate, and suitable for industrialized promotion and application.

Description

A kind of health product assisting treatment joint disease and preparation method thereof
Technical field
The present invention relates to health care medicine technical field, be specifically related to a kind of guarantor assisting treatment joint disease Strong product and preparation method thereof.
Background technology
Along with the aging trend of China's population, joint disease also becomes that we have to face Major issue.Because joint disease directly affects the quality of life of old people.With regard to the feelings that China is current For condition, the old people of more than 60 years old, there is more than half to have joint disease in various degree, there are about The misery that the joint disease that the people of more than 100000000 is just bearing brings.Osteoarthritis and rheumatoid arthritis The life of the most several hundred million people is being affected etc. the joint disease caused.And in following 20 years, this One numeral also can increase sharply, and over-65s aging population quantity will be double.The pain of osteoarthritis and Dysfunction causes the seriousness of disability, the most even greater than cardio-cerebrovascular diseases.
Joint disease be almost each old man can faced by problem, and the treatment of joint disease Journey is a process the veryest long.The not only patient being in a bad way itself needs to bear the torment of slight illness, Also household can be caused and tie down.The most also occur in that at present multiple for joint disease, there is treatment and make Medicine, such as bis phosphoric acid salt, calcitonin class, estrogens anti-bone resorption medicine;Parathyroid hormone The promoting bone growing medicines such as element;The calcium preparation such as calcium carbonate, activated calcium, calcium gluconate, calcium lactate;A Fa The vitamin D class medicine such as ostelin, calcitriol.And occur that some add and use Chinese medicine ingredients to control Treat the joint disease such as osteoporosis.
But have medicative Western medicine for joint disease the most on the market or add Chinese medicine ingredients Chinese and Western bound drug, effect is the most undesirable.As Chinese patent CN103960669A discloses a kind of energy Increasing skeleton nutrition and increase the D-glucosamine health product of bone density, its component is by D-glucosamine potassium sulfate salt 220-280 part, chondroitin sulfate 180-230 part, calcium carbonate 140-170 part, bone collagen 50-80 Part, magnesium stearate 3-8 part composition.In this patent, use the glucosamine of potassium sulfate salt, in reality In the application on border, the form entering internal glucosamine salt will be dissociated into glucosamine, and Actual work is also glucosamine, and unrelated with sulfate or hydrochlorate.But because of potassium sulfate salt The solution moisture absorption, is unfavorable for storing, so producer would generally add other adjuvant in preparation so that it is no Easily the moisture absorption is dissolved, and causes its material content low, the purity of only about 80% simultaneously.Chinese patent CN103251671A discloses a kind of compositions containing Chinese medicine increasing bone density and preparation method thereof, its system Preparation Method be Herba Epimedii, Rhizoma Drynariae, Radix Achyranthis Bidentatae by extracting, filter, concentrate, the operation such as be dried and make After powder, and other component mixing granulations, fill and make hard capsule.This preparation method complexity is loaded down with trivial details, no Easily operation, and the Chinese medicine ingredients such as Herba Epimedii, Rhizoma Drynariae, Radix Achyranthis Bidentatae is because planting in the place of production, weather, season etc. The difference of environment, effect content of its every batch medical material is not quite similar, and by extracting, filter, concentrating, does Easily there is differentiation in powder effect content that the operation such as dry prepares, and causes every batch of finished product effect content not Stable, and affect finished product curative effect.
Summary of the invention
In order to overcome the defect of prior art, it is an object of the invention to provide a kind of auxiliary treatment osteoarthrosis disease Sick health product, said composition formula is simple, and can Efficient software patching cartilage, improve bone density, simultaneously Dredging osteoarthrosis blood microcirculation, expedites the emergence of knuckle synovia, removes injurious factor, anti-inflammatory analgetic, effectively changes Kind osteoarthrosis is undermined alleviates arthralgia problem, and constant product quality, taking convenience, safely and effectively, Have no side effect, can long-term taking.
Meanwhile, the present invention also resides in the preparation method providing a kind of health product assisting treatment joint disease.
In order to realize object above, the technical solution adopted in the present invention is:
A kind of health product assisting treatment joint disease, mainly by the raw material preparation of following parts by weight Become: glucosamine hydrochloride 355-395 part, chondroitin sulfate 110-150 part, calcium carbonate 280-320 Part, fish collagen 110-150 part, disintegrating agent 18-22 part, binding agent 36-44 part, lubricant 3-7 Part.
Described disintegrating agent is carboxymethyl starch sodium.
Described binding agent is made up of the component of following parts by weight: polyvidone 18~22 parts, hypromellose Element 18~22 parts.
Described lubricant is magnesium stearate.
The health product of above-mentioned auxiliary treatment joint disease, mainly by the raw material preparation of following parts by weight Become: glucosamine hydrochloride 375 parts, chondroitin sulfate 130 parts, calcium carbonate 300 parts, collagen 130 parts of albumen, disintegrating agent 20 parts, polyvidone 20 parts, hypromellose 20 parts, lubricant 5 Part.
The preparation method of the health product of above-mentioned auxiliary treatment joint disease, including following operating procedure:
1) take polyvidone to be dissolved in ethanol, obtain binder solution;
2) calcium carbonate and fish collagen are added step 1) in the binder solution prepared, prepare soft material, Granulation, dry, granulate, obtain particulate matter;
3) by step 2) particulate matter prepared and glucosamine hydrochloride, chondroitin sulfate, disintegrating agent, Hypromellose, mix lubricant are uniform, and tabletting obtains tablet element sheet;
4) by step 3) prepare tablet element sheet carry out film coating process, obtain described increase bone close The pharmaceutical composition of degree.
Step 1) described in ethanol be mass concentration be the ethanol of 50-95%;Step 1) described in ethanol It is 9:1 with the mass ratio of polyvidone.
Step 2) described in be dried as being dried to moisture < 10% under the conditions of 30~60 DEG C.
Step 2) described in granulate be that 20 mesh sieves carry out granulate.
Step 4) in film coating process method particularly includes: tablet element sheet is put in coating pan, opens Heating and air intake switch, and rotate 10~25 minutes, open spray gun, make tablet element sheet uniform bag last layer Coating membrane, holding inlet temperature 50~70 DEG C, rotating speed 2r/min.
Glucosamine hydrochloride can promote the main component proteoglycan of articular cartilage and collagen fiber Generate, the articular cartilage that continuous reparation has been worn or has corroded, and new articular cartilage and cunning can be generated Film, thus recover the normal physiological function of joint part.D-glucosamine can also stimulate chondrocyte to synthesize consumingly Collagen protein in human body and hyaluronic acid, promote that knuckle synovia generates, thus constantly lubricating joint cartilage Surface, reduces the friction between joint, improves function of joint
Chondroitin sulfate can inhibitory activity oxygen, Signal regulated kinase and the activity of mitogen activated protein kinase, Thus lower proinflammatory factor and the synthesis of suppression prostaglandin, thus there is analgesic antiphlogistic effect, slow down pass The joint symptom such as pain, swelling.Synergism can be played when chondroitin sulfate and D-glucosamine combination application, can increase Adding the content of cartilage matrix, more effectively Saving cortilage cartilage, reverse damage and promote injury repairing, enter And alleviating pain, improve function of joint.
Fish collagen can recover normal bone metabolism, maintains normal bone amount, simultaneously facilitates hyaluronic acid Generate, thus increase the lubrication between articular cartilage, finally improve arthralgia and prevention joint ageing.
Calcium is skeleton and osteoarticular important composition composition, can increase bone density and intensity, and prevention sclerotin is dredged Pine
The present invention assists the health product for the treatment of joint disease, with glucosamine hydrochloride, chondroitin sulfate Element, calcium carbonate, fish collagen are effective ingredient, add the preparations such as disintegrating agent, binding agent, lubricant Form, by limiting the consumption of each raw material, make between each raw material the most collaborative, play potentiation, make The health product energy Efficient software patching cartilage of preparation, raising bone density, simultaneously dredging osteoarthrosis blood microcirculation, Expedite the emergence of knuckle synovia, remove injurious factor, anti-inflammatory analgetic, be effectively improved osteoarthrosis and undermined and alleviate joint Pain problem, constant product quality, taking convenience, safely and effectively, have no side effect, can long-term taking.
The present invention assists the preparation method of the health product for the treatment of joint disease, easy and simple to handle, it is easy to control, Be suitable to industrial application.
It addition, the present invention uses the glucosamine of hydrochloride form, because it need not additionally add adjuvant, Its purity reaches more than 99%.And the supplementary material stability of present invention employing is the highest, in pelletization Temperature is low, does not affect product stability, and after making granule, mobility increases, and is conducive to increasing product Loading amount stability.The product of the present invention finally increases enrobing processes, effective prevention external environment humiture, The impact on product such as oxygen, improves the stability in its shelf life.And the bad smell of product can be covered, It is beneficial to be esthetically acceptable to the consumers.
Detailed description of the invention
Below by specific embodiment, technical scheme is described in detail.
Embodiment 1
A kind of health product assisting treatment joint disease, mainly by the raw material preparation of following parts by weight Become: glucosamine hydrochloric acid 375 parts, chondroitin sulfate 130 parts, calcium carbonate 300 parts, collagen egg White 130 parts, carboxymethylstach sodium 20 parts, polyvidone 20 parts, hypromellose 20 parts, magnesium stearate 5 parts.
The preparation method of the health product of the present embodiment auxiliary treatment joint disease, concrete operation step is as follows:
1) preparation of binder solution: take that polyvidone is dissolved in that mass concentration is 95% by weight 180 In the ethanol of weight portion, obtain binder solution;
2) pelletize
Calcium carbonate and fish collagen are added step 1) in the binder solution prepared, make soft or hard suitable Soft material and pelletize, be dried under the conditions of 40 DEG C to moisture < 10%, cross 20 mesh sieve granulate, obtain particulate matter;
3) mixing
By step 2) particulate matter prepared and glucosamine hydrochloride, chondroitin sulfate, carboxymethylstach sodium, Hypromellose, magnesium stearate mixing 20min, obtains mixture.
4) tabletting
By step 3) mixture prepared puts in the hopper of tablet machine, regulates loading, pressure, carry out Sheeting operation, obtains tablet element sheet;In tableting processes, require that hardness is moderate, unilateral smooth, not sticking;
5) coating
By step 4) the tablet element sheet prepared puts in coating pan, and open heating and air intake switchs, rotate 15 Minute, open spray gun, make tablet element sheet uniform bag last layer coating membrane, keep inlet temperature 60 DEG C, Rotating speed 2r/min, obtains the pharmaceutical composition of described increase bone density.
Embodiment 2
A kind of health product assisting treatment joint disease, mainly by the raw material preparation of following parts by weight Become: glucosamine hydrochloric acid 355 parts, chondroitin sulfate 110 parts, calcium carbonate 320 parts, collagen egg White 150 parts, carboxymethylstach sodium 20 parts, polyvidone 20 parts, hypromellose 20 parts, magnesium stearate 5 parts.
The preparation method of the health product of the present embodiment auxiliary treatment joint disease, concrete operation step is as follows:
1) preparation of binder solution: take that polyvidone is dissolved in that mass concentration is 50% by weight 180 In the ethanol of weight portion, obtain binder solution;
2) pelletize
Calcium carbonate and fish collagen are added step 1) in the binder solution prepared, make soft or hard suitable Soft material and pelletize, be dried under the conditions of 60 DEG C to moisture < 10%, cross 20 mesh sieve granulate, obtain particulate matter;
3) mixing
By step 2) particulate matter prepared and glucosamine hydrochloride, chondroitin sulfate, carboxymethylstach sodium, Hypromellose, magnesium stearate mixing 30min, obtains mixture.
4) tabletting
By step 3) mixture prepared puts in the hopper of tablet machine, regulates loading, pressure, carry out Sheeting operation, obtains tablet element sheet;In tableting processes, require that hardness is moderate, unilateral smooth, not sticking;
5) coating
By step 4) the tablet element sheet prepared puts in coating pan, and open heating and air intake switchs, rotate 20 Minute, open spray gun, make tablet element sheet uniform bag last layer coating membrane, keep inlet temperature 50 DEG C, Rotating speed 2r/min, obtains the pharmaceutical composition of described increase bone density.
Embodiment 3
A kind of health product assisting treatment joint disease, mainly by the raw material preparation of following parts by weight Become: glucosamine hydrochloric acid 395 parts, chondroitin sulfate 150 parts, calcium carbonate 280 parts, collagen egg White 110 parts, carboxymethylstach sodium 20 parts, polyvidone 18 parts, hypromellose 21 parts, magnesium stearate 6 parts.
The preparation method of the health product of the present embodiment auxiliary treatment joint disease, concrete operation step is as follows:
1) preparation of binder solution: take that polyvidone is dissolved in that mass concentration is 75% by weight 180 In the ethanol of weight portion, obtain binder solution;
2) pelletize
Calcium carbonate and fish collagen are added step 1) in the binder solution prepared, make soft or hard suitable Soft material and pelletize, be dried under the conditions of 30 DEG C to moisture < 10%, cross 20 mesh sieve granulate, obtain particulate matter;
3) mixing
By step 2) particulate matter prepared and glucosamine hydrochloride, chondroitin sulfate, carboxymethylstach sodium, Hypromellose, magnesium stearate mixing 10min, obtains mixture.
4) tabletting
By step 3) mixture prepared puts in the hopper of tablet machine, regulates loading, pressure, carry out Sheeting operation, obtains tablet element sheet;In tableting processes, require that hardness is moderate, unilateral smooth, not sticking;
5) coating
By step 4) the tablet element sheet prepared puts in coating pan, and open heating and air intake switchs, rotate 10 Minute, open spray gun, make tablet element sheet uniform bag last layer coating membrane, keep inlet temperature 70 DEG C, Rotating speed 2r/min, obtains the pharmaceutical composition of described increase bone density.
Embodiment 4
A kind of health product assisting treatment joint disease, mainly by the raw material preparation of following parts by weight Become: glucosamine hydrochloric acid 370 parts, chondroitin sulfate 120 parts, calcium carbonate 300 parts, collagen egg White 137 parts, carboxymethylstach sodium 22 parts, polyvidone 22 parts, hypromellose 22 parts, magnesium stearate 7 parts.
Its preparation method is with embodiment 1.
Embodiment 5
A kind of health product assisting treatment joint disease, mainly by the raw material preparation of following parts by weight Become: glucosamine hydrochloric acid 380 parts, chondroitin sulfate 140 parts, calcium carbonate 310 parts, collagen egg White 113 parts, carboxymethylstach sodium 18 parts, polyvidone 18 parts, hypromellose 18 parts, magnesium stearate 3 parts.
Its preparation method is with embodiment 2.
Embodiment 6
A kind of health product assisting treatment joint disease, mainly by the raw material preparation of following parts by weight Become: glucosamine hydrochloric acid 358 parts, chondroitin sulfate 144 parts, calcium carbonate 290 parts, collagen egg White 145 parts, carboxymethylstach sodium 19 parts, polyvidone 20 parts, hypromellose 19 parts, magnesium stearate 5 parts.
Its preparation method is with embodiment 3.
Embodiment 7
A kind of health product assisting treatment joint disease, mainly by the raw material preparation of following parts by weight Become: glucosamine hydrochloric acid 360 parts, chondroitin sulfate 130 parts, calcium carbonate 300 parts, collagen egg White 148 parts, carboxymethylstach sodium 20 parts, polyvidone 21 parts, hypromellose 18 parts, magnesium stearate 3 parts.
Its preparation method is with embodiment 2.
Comparative example 1
This comparative example is in the containing of increase bone density of Chinese patent CN103251671A embodiment 3 preparation The health product of medicine.
Comparative example 2
This comparative example is increasing skeleton nutrition and carrying of Chinese patent CN10390669A embodiment 3 preparation The D-glucosamine health product of high bone density.
Test example 1
1 material and method
1.1 samples: sample is the health product of the embodiment of the present invention 1 preparation, and people's oral recommended dose is every day 4g, adult's body weight is pressed 60kg and is calculated, converts into dosage 0.0667g/kg.bw.Sample calcium content is about 12.2%
1.2 laboratory animals: the wound Animal Science portion offer of selection east, Kaifu District, Changsha (production licence number: SCXK (Hunan) 2009-0012) the SPF level healthy SD female mice bred, body weight 60-75g, altogether 50, it is divided into 5 groups, often group 10.
1.3 experimental situations: experimental situation temperature 22-24 DEG C, humidity 52-56%, laboratory animal uses license Card number is SYXK (Hunan) 2010-0011.
1.3 dosage choice and tested material give mode:
Low calcium feed formula (g%): casein 10.0, analysis for soybean powder 15.0, wheat flour 54.0, Oleum Arachidis hypogaeae semen 4.0, cellulose 2.0, AIN-76 salt-mixture 2.6, AIN-76 mixed vitamin 1.0, choline chloride 0.2, DL-methionine 0.2, starch 11.0, add CaCO3 and make feed calcium content reach 150mg/100g, make For low calcium feedstuff, this feedstuff is purchased from Beijing green permanent spring nutritional health food technological development company limited.
According to human oral's recommended amounts, experiment sets three dosage groups, it may be assumed that 0.333g/kg.bw, 0.667g/kg.bw, 2.000g/kg.bw, the dosage of basic, normal, high three groups be respectively equivalent to 5 times of human body recommended intake, 10 times, 30 times.Calcium carbonate control group gives the calcium carbonate of 0.610g/kg.bw dosage and (is equivalent to this sample The calcium content of high dose).During sample configuration, the guarantor of basic, normal, high dosage Example 1 preparation respectively Strong product 6.66g, 13.34g, 40.00g add 1% carboxymethyl cellulose and take to 200ml, calcium carbonate control group 12.20 calcium carbonate add 1% carboxymethyl cellulose to 200ml, and low calcium matched group gives isopyknic 1% carboxylic first Base cellulose, respectively give animal subject gavage, every day gavage 1 time, gavage volume is 1.0ml/100g.bw.
From on-test, all single cage of each treated animal is raised, and feed low calcium feedstuff, gavage gives respective being subject to Test solution, drinks deionized water, 3 totally months.
1.4 instruments and reagent
SD-1000C bone mineral measuring instrument (Beijing Geology Research Inst., Ministry of Nuclear Industry's centre)
1.5 experimental techniques:
1.5.1 animal growth index: body weight of weighing weekly and height.
1.5.2 metabolism: give this product after 4 weeks, rat is placed in rustless steel metabolic cage and carries out three days Metabolism, collects 72 hours feces, urine, with EDTA titration measuring calcium content.
1.5.3 femoral bmd measures: at the end of experiment, and sacrificed by decapitation rat peels off right femur, through 105 DEG C Baking box is baked to constant weight, after being cooled to room temperature, measure femur midpoint and the bone density of distal end.
1.5.4 the mensuration of calcium content of bone: after weighing the gross weight of femur, use EDTA titration measuring.
1.6 experimental data statistics: carrying out variance analysis with SPSS software, result is with mean+SD Represent.
1.7 result criterion
Give the calcium content of bone of tested material group or bone density be significantly higher than low calcium matched group, and with same dose carbon Acid calcium matched group is compared and is not significantly different from, and the absorbance of calcium is not less than calcium carbonate control group, can determine that this Tested material has the effect increasing bone density.
2. experimental result
2.1 impacts on rat body weight, as shown in table 1,
Table 1
From table 1, initial, mid-term and the body weight in latter stage of each experimental group rat and have a net increase of value added and low Calcium matched group compares, and there was no significant difference (P > 0.05);Initial, mid-term of high dose experimental group rat, Latter stage, body weight and having a net increase of value added compared with calcium carbonate control group, there was no significant difference (P > 0.05).
2.2 impacts on rat height, as shown in table 2:
Table 2
From table 2, the initial height of each experimental group rat compares with low calcium matched group, poor without significance Different (P > 0.05);High dose group and calcium carbonate control group rat height in latter stage and net added value thereof, low, middle dose Amount group height net added value compares with low calcium matched group, has significant difference (P < 0.05);High dose is tested Initial, the mid-term of group rat and height in latter stage and net added value thereof compare with calcium carbonate control group, without significance Difference (P > 0.05).
2.3 on rat femur length and the impact of bone density, as shown in table 3:
Table 3
The biggest from table 3, calcium carbonate control group and high dose group femur center and distal end bone density In low calcium matched group, middle dosage group femur center density is noticeably greater than low calcium matched group, has significance poor Different (P < 0.05);The femur length of high dose group rat, center and distal end bone density and corresponding carbonic acid Calcium matched group compares, and there was no significant difference (P > 0.05).
2.4 on rat femur weight and the impact of calcium content, as shown in table 4 below:
Table 4
From table 4, the femur calcium content of calcium carbonate control group and high dose group rat and TC are the biggest In low calcium matched group, there is significant difference (P < 0.05);The femur weight of high dose group rat, calcium contain Amount and TC compare with corresponding calcium carbonate control group, there was no significant difference (P > 0.05)
Rat is taken in calcium, excrement calcium and the impact of urine calcium by 2.5, as shown in table 5 below:
Table 5
From table 5, the absorption calcium of high dose group rat, excrement calcium and urine calcium output and corresponding calcium carbonate Matched group compares, and there was no significant difference (P > 0.05);Calcium carbonate control group and basic, normal, high dosage group are big Mus is taken in calcium and is significantly higher than low calcium matched group (P < 0.05);Calcium carbonate control group and middle and high dosage group rat Excrement calcium, urine calcium output be significantly higher than low calcium matched group (P < 0.05).
2.6 impacts on calcium in rats metabolism, as shown in table 6 below:
Table 6
From table 6, the apparent absorptivity of high dose group calcium and Retention and corresponding calcium carbonate control group ratio Relatively, there was no significant difference (P > 0.05);Calcium carbonate control group and the apparent absorption of high dose experimental group rat Rate and Retention are substantially less than low calcium matched group (P < 0.05).
3. brief summary
Test result indicate that, with the health product of basic, normal, high dosage to rat oral gavage 3 months after, high dose Group rat latter stage height and have a net increase of value added, femur center and the bone density of distal end, femur calcium content and TC, absorption calcium, excrement calcium, urine calcium content are significantly higher than low calcium matched group, and apparent absorptivity and calcium are deposited Stay rate to be substantially less than low calcium matched group, there is significant difference (P < 0.05);Dosage group rat low, middle Take in calcium and be significantly higher than low calcium matched group, middle dosage group femur center bone density, excrement calcium, urine calcium output It is significantly higher than low calcium matched group, there is significant difference (P < 0.05).High dose experimental group rat every Index compares with corresponding calcium carbonate control group, there was no significant difference (P > 0.05).Result shows the present invention Health product have the effect increasing rat bone density.
Test example 2
2.1 subjects data: knee osteoarthritis patients 90 example.It is randomly divided into test group and comparison Group 1, matched group 2.Test group 30 example, male 14 examples, female 16 example, age 55~72 years old, average year Year in age (62.4 ± 0.9), the course of disease 1~6 years, average 4.5 years;Matched group 1,30 examples, male 13 examples, female 17 examples, age 53~73 years old, year mean age (62.1 ± 1.1), the course of disease 11 months~6 years, average 4.2 Year;Matched group 2,30 examples, male 15 examples, female 15 example, age 55~73 years old, the mean age (62.3 ± 1.0) year, the course of disease 13 months~6 years, average 4.3 years;3 groups of patient's physical data no statistical difference meanings Justice, P > 0.05, there is comparability.
2.2 test methods:
The health product of test group patients received oral's embodiment 1 preparation, every day 2 times, each 2, continuous mouth Take 14 days;Matched group 1 uses product prepared by comparative example 1, every day 2 times, each 2, continuous mouth Take 14 days.Matched group 2 uses product prepared by comparative example 2, every day 2 times, each 2, continuous mouth Take 14 days.Curative effect is added up after terminating the course for the treatment of.
2.3 observation index
Test group treatment before and after and with compare clinical symptoms after treatment of control group, the quantization of various symptom and signs is commented Point.
2.4 statistical analysis
2.4.1 criterion of therapeutical effect: with reference to " Chinese medical disease Standardization of diagnosis and curative effect ".Cure: sings and symptoms is complete Disappearing, freely, functional rehabilitation is normal for joint motion;Effective: sings and symptoms is wholly absent, can participate in Normal work or work, though there being slight sense of discomfort, but after taking a break, symptom can disappear;Effective: disease Shape and sign have been alleviated, and function of joint is the most limited, and life can be taken care of oneself;Invalid: sings and symptoms without Improve or increase the weight of.
2.4.2 standards of grading: the seriousness of knee joint osseous arthritis and activeness with reference to Lequesne refer to Number Evaluation Method formulates grade form, marks to before and after patient treatment.0 point: without pain, walking is unrestricted, Stiff without morning, stair activity and squat down normal, tenderness is normal, without swelling;1 point: mild pain, walking < 1000m, morning deadlock < 1min, stair activity and slightly pain, pain during weight, slightly swelling when squatting down;2 Point:
Pain can be stood, and walking is 500~1000m, and morning is stiff 1~15min, stair activity and under Squatting the most movable, pain during moderate pressure, Xiyan is not clear;3 points: pain is difficult to stand, walking < 500 M,
Morning deadlock > 15min.Can not stair activity and squatting down, pain during light pressure, Xiyan is unclear.Statistics Processing and use SPSS 18.00 software, measurement data uses mean ± standard deviation (x ± s) to represent, uses t inspection Testing, enumeration data uses % to represent, uses chi-square criterion, and P < 0.05 is that difference is statistically significant.
2.5 therapeutic outcome
2.5.1 comparitive study is shown in Table 1.
Table 1
Group n Effective Effectively Invalid Obvious effective rate/% Total effective rate/%
Test group 30 21 7 2 70 93.3*
Matched group 1 30 14 6 10 46.2 66.7
Matched group 2 30 15 6 9 50 70
Note: compare * P < 0.05 with matched group 1, compares * P < 0.05 with matched group 2.
2.5.2 clinical symptoms and sign scalar quantization scoring comparable situation are shown in Table 2.
Before and after table 2 treatment, the Quantitative marking of various symptom and signs compares (x ± s)
Note: compare with before treatment, * P < 0.05;Compare with matched group 1, #P < 0.05, with matched group 2 Relatively, #P < 0.05.
2.6 conclusions: show from above experiment, the clinical efficacy of test group is substantially better than matched group 1 and comparison Group 2, this result shows that health product prepared by the present invention are better than comparative example for the therapeutic effect of joint disease 1 and comparative example 2 preparation product.

Claims (10)

1. the health product assisting treatment joint disease, it is characterised in that main by following weight portion The raw material of number is prepared from: glucosamine hydrochloride 355-395 part, chondroitin sulfate 110-150 part, Calcium carbonate 280-320 part, fish collagen 110-150 part, disintegrating agent 18-22 part, binding agent 36-44 Part, lubricant 3-7 part.
2. the health product of auxiliary treatment joint disease as claimed in claim 1, it is characterised in that institute Stating disintegrating agent is carboxymethyl starch sodium.
3. the health product of auxiliary treatment joint disease as claimed in claim 1, it is characterised in that institute State binding agent to be made up of the component of following parts by weight: polyvidone 18~22 parts, hypromellose 18~22 Part.
4. the health product of auxiliary treatment joint disease as claimed in claim 1, it is characterised in that institute Stating lubricant is magnesium stearate.
5. the health product of auxiliary treatment joint disease as claimed in claim 3, it is characterised in that main To be prepared from by the raw material of following parts by weight: glucosamine hydrochloride 375 parts, chondroitin sulfate 130 parts, calcium carbonate 300 parts, fish collagen 130 parts, disintegrating agent 20 parts, polyvidone 20 parts, Hypromellose 20 parts, lubricant 5 parts.
6. a preparation method for the health product of auxiliary treatment joint disease as claimed in claim 3, It is characterized in that, including following operating procedure:
1) take polyvidone to be dissolved in ethanol, obtain binder solution;
2) calcium carbonate and fish collagen are added step 1) in the binder solution prepared, prepare soft material, Granulation, dry, granulate, obtain particulate matter;
3) by step 2) particulate matter prepared and glucosamine hydrochloride, chondroitin sulfate, disintegrating agent, Hypromellose, mix lubricant are uniform, and tabletting obtains tablet element sheet;
4) by step 3) prepare tablet element sheet carry out film coating process, obtain described increase bone close The pharmaceutical composition of degree.
7. the preparation method of the health product of auxiliary treatment joint disease as claimed in claim 6, it is special Levy and be, step 1) described in ethanol be mass concentration be the ethanol of 50-95%;Step 1) described in Ethanol is 9:1 with the mass ratio of polyvidone.
8. the preparation method of the health product of auxiliary treatment joint disease as claimed in claim 6, it is special Levy and be, step 2) described in be dried as being dried to moisture < 10% under the conditions of 30~60 DEG C.
9. the preparation method of the health product of auxiliary treatment joint disease as claimed in claim 6, it is special Levy and be, step 2) described in granulate be that 20 mesh sieves carry out granulate.
10. the preparation method of the health product of auxiliary treatment joint disease as claimed in claim 6, its Be characterised by, step 4) in film coating process method particularly includes: tablet element sheet is put in coating pan, Open heating and air intake switchs, rotate 10~25 minutes, open spray gun, make tablet element sheet wrap uniformly One layer of coating membrane, holding inlet temperature 50~70 DEG C, rotating speed 2r/min.
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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108065367A (en) * 2017-12-13 2018-05-25 上海锐因生物科技有限公司 It is a kind of for composition of joint care and preparation method thereof
CN112023030A (en) * 2020-09-09 2020-12-04 山东润德生物科技有限公司 Ammonia sugar probiotic bone collagen peptide formula for nursing bone joint neogenesis
CN112826925A (en) * 2021-04-12 2021-05-25 仕医堂(吉林)生物药业有限公司 Traditional Chinese medicine liquid for treating osteoarticular diseases and preparation method thereof

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102342404A (en) * 2011-09-23 2012-02-08 北京东方红航天生物技术股份有限公司 Composite calcium preparation
CN102698254A (en) * 2012-06-05 2012-10-03 哈尔滨珍宝制药有限公司 Composition for increasing bone mineral density, preparation agent containing same, and preparation method of same
CN102949710A (en) * 2012-05-08 2013-03-06 北京润康普瑞生物技术有限公司 Pharmaceutical composition or healthcare product for increasing bone mineral density and preparation method of pharmaceutical composition or healthcare product
CN104382005A (en) * 2013-08-19 2015-03-04 宣城柏维力生物工程有限公司 Glucosamine chondroitin collagen tablet and preparation method thereof
CN104543674A (en) * 2015-01-04 2015-04-29 北京世纪合辉医药科技股份有限公司 Health food for improving bone and joint health as well as preparation method thereof

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102342404A (en) * 2011-09-23 2012-02-08 北京东方红航天生物技术股份有限公司 Composite calcium preparation
CN102949710A (en) * 2012-05-08 2013-03-06 北京润康普瑞生物技术有限公司 Pharmaceutical composition or healthcare product for increasing bone mineral density and preparation method of pharmaceutical composition or healthcare product
CN102698254A (en) * 2012-06-05 2012-10-03 哈尔滨珍宝制药有限公司 Composition for increasing bone mineral density, preparation agent containing same, and preparation method of same
CN104382005A (en) * 2013-08-19 2015-03-04 宣城柏维力生物工程有限公司 Glucosamine chondroitin collagen tablet and preparation method thereof
CN104543674A (en) * 2015-01-04 2015-04-29 北京世纪合辉医药科技股份有限公司 Health food for improving bone and joint health as well as preparation method thereof

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
崔福德: "《药剂学》", 31 August 2011, 人民卫生出版社 *

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108065367A (en) * 2017-12-13 2018-05-25 上海锐因生物科技有限公司 It is a kind of for composition of joint care and preparation method thereof
CN112023030A (en) * 2020-09-09 2020-12-04 山东润德生物科技有限公司 Ammonia sugar probiotic bone collagen peptide formula for nursing bone joint neogenesis
CN112826925A (en) * 2021-04-12 2021-05-25 仕医堂(吉林)生物药业有限公司 Traditional Chinese medicine liquid for treating osteoarticular diseases and preparation method thereof
CN112826925B (en) * 2021-04-12 2022-09-06 仕医堂(吉林)生物药业有限公司 Traditional Chinese medicine liquid for treating osteoarticular diseases and preparation method thereof

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