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 PDFInfo
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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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Classifications
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- A—HUMAN NECESSITIES
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- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
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- A61K31/737—Sulfated polysaccharides, e.g. chondroitin sulfate, dermatan sulfate
-
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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
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.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610262529.XA CN105770850A (en) | 2016-04-25 | 2016-04-25 | Health care product for adjuvant treatment of osteoarticular diseases and preparation method of health care product |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610262529.XA CN105770850A (en) | 2016-04-25 | 2016-04-25 | Health care product for adjuvant treatment of osteoarticular diseases and preparation method of health care product |
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| CN105770850A true CN105770850A (en) | 2016-07-20 |
Family
ID=56399263
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201610262529.XA Pending CN105770850A (en) | 2016-04-25 | 2016-04-25 | Health care product for adjuvant treatment of osteoarticular diseases and preparation method of health care product |
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| CN (1) | CN105770850A (en) |
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| 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 |
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Cited By (4)
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| 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 |
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