CN103720710A - Pharmaceutical composition capable of increasing bone density and preparation method of pharmaceutical composition - Google Patents
Pharmaceutical composition capable of increasing bone density and preparation method of pharmaceutical composition Download PDFInfo
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- CN103720710A CN103720710A CN201310715610.5A CN201310715610A CN103720710A CN 103720710 A CN103720710 A CN 103720710A CN 201310715610 A CN201310715610 A CN 201310715610A CN 103720710 A CN103720710 A CN 103720710A
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Abstract
The invention discloses a pharmaceutical composition capable of increasing bone density. The pharmaceutical composition is prepared from the following raw materials in parts by weight: 150-350 parts of calcium carbonate, 100-250 parts of D-glucosamine hydrochloride and 0.2-0.6 part of vitamin D. The pharmaceutical composition, for reasons of osteoporosis, can prevent bone loss and increase bone density through methods of supplementing calcium, repairing cartilage injury and protecting bone joint; the pharmaceutical composition can be used for preventing and controlling osteoarthritis and osteoporosis.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition and preparation method thereof, particularly relate to a kind of pharmaceutical composition that increases bone density and preparation method thereof.
Background technology
Osteoporosis is a kind of human health, commonly encountered diseases that sickness rate is high of having a strong impact on, and along with the aging of population in the world, has become one of focus of world medical circle research.Osteoporosis is that a kind of bone amount of general reduces and osseous tissue microstructure changes, and the fragility of bone increases, and the strength decreased of bone, in without wound or slight wound situation, the disease of fracture can occur.Osteoporosis in early days can be without any symptom, therefore be referred to as soundless epidemic diseases.Pain, figure's distortion, hunchback, height that the patient of osteoporosis shows as whole body skeleton shorten and a series of complication, and wherein fracture is the most serious complication, and therapeutic effect is often not good, even causes lifelong deformity, to patient, causes great pain.
The reason of osteoporosis and the loss of bone amount occur substantial connection, the intensity of bone and complete, depend on the suction to bone of osteoclast from hemopoietic tissue and from the osteoblast of bone marrow matrix to the balance between the reconstruction of bone.Middle-aged and elderly people is along with the minimizing of vitamin D in the dyssecretosis of the minimizing of age ageing, sex hormones secretion, calcium-regulating hormone, body or due to disease reasons such as osteoarthritis, cartilage injurys, bone resorption has exceeded bone formation, occurs bone loss.The product that increases bone substance density improving function on market in health food is the medicament composing prescription in conjunction with kidney-nourishing tcm drug or protection cartilaginous tissue, anti-arthritis mainly with calcium preparation; health food with its safety, can be edible for a long time advantage; as supplementing of medicine; for the control of osteoporosis provides good selection; make osteoporosis easily suffer from the people of fracture; can early intervention treat, avoid occurring severe complication.The principle of medication of integrated control osteoporosis of the present invention, for the reason of osteoporosis morbidity, takes supplement calcium and repairs cartilage injury, protects osteoarticular method to prevent bone loss, increases bone density, thus protect against osteoporosis.
Summary of the invention
The technical problem to be solved in the present invention is to provide one and has increase bone substance density improving function, for the pharmaceutical composition of protect against osteoporosis.
Another technical problem that the present invention will solve is to provide the preparation method of this pharmaceutical composition.
For solving the problems of the technologies described above, the present invention is achieved by the following technical solutions:
Increase a pharmaceutical composition for bone density, by the raw material of following weight portion, made: 150～350 parts of calcium carbonate, 100～250 parts of D-Glucosamine Hydrochlorides, vitamin D
30.2～0.6 part.
The above increases the pharmaceutical composition of bone density, preferably by the raw material of following weight portion, is made: 200～300 parts of calcium carbonate, 150～200 parts of D-Glucosamine Hydrochlorides, vitamin D
30.3～0.5 part.
The above increases the pharmaceutical composition of bone density, further preferably by the raw material of following weight portion, is made: 250 parts of calcium carbonate, 170 parts of D-Glucosamine Hydrochlorides, vitamin D
30.4 part.
Utilize above-mentioned raw materials formula, galenic pharmacy method that can be routinely, adds suitable adjuvant and makes various preparations, as: capsule, tablet etc.
Preparation method comprises the steps:
A. according to formula ratio, take D-Glucosamine Hydrochloride, vitamin D
3and calcium carbonate;
B. by D-Glucosamine Hydrochloride, vitamin D
3mix homogeneously, obtains mixed powder A, standby;
C. calcium carbonate, mixed powder A, right amount of auxiliary materials are put to mix homogeneously in mixer, make preparation, obtain.
D-Glucosamine Hydrochloride, vitamin D in above-mentioned steps b
3mixing can adopt equivalent incremental method mix homogeneously.
Adjuvant described in method for making can be starch, magnesium stearate etc., and its use amount is pressed galenic pharmacy conventional amount used and determined.
In the present invention, calcium carbonate can be used as again bone formation-promoter as bone resorption inhibitor and guarantee the balance between bone formation and bone resorption.Conventionally concerning middle-aged and elderly people, take in enough calcium constituents every day, then coordinate suitable vitamin D
3strengthening, just can guarantee the balance between bone formation and bone resorption, prevention of osteoporosis.D-Glucosamine Hydrochloride can increase the synthetic of human body chondrocyte specificity II Collagen Type VI, the activity of polymerization element enzyme in the chondrocyte of inhibition IL-1 mediation, thereby reducing arthrosis human cartilage loses, there is the differentiation of the preosteoblast of promotion, accelerate osteoplastic effect, to the growth of subperiosteum callus, can play the guiding role.Vitamin D3 is the necessary fatsoluble vitamin of human body, has and promotes the absorption of small intestinal to calcium, promotes calcium and the deposition of phosphorus in skeleton, promotes the re-absorbed effect of kidney to calcium, phosphorus.In addition vitamin D,
3bone resorption, bone mineralising, bone formation, bone development are had to direct effect.The present invention by calcium carbonate in conjunction with vitamin D
3for body supplement calcium, guarantee the balance between bone formation and bone resorption; D-Glucosamine Hydrochloride protection cartilaginous tissue, prevents and treats osteoarthritis; Three kinds of raw materials coordinate common performance to increase the health care of bone density.
By reading description and appending claims below, can understand better these and other feature, aspect and advantage of the present invention.
The specific embodiment
Although this description by particularly pointing out and knowing that claimed claims of the present invention draw a conclusion, should be believed following explanation and will understand better the present invention.
As used herein, word " preferably " and variant refer to embodiment of the present invention that specific beneficial effect can be provided under specific environment.But other embodiment can be also preferred under identical or other environment.In addition, the detailed description of one or more preferred embodiments does not represent that other embodiment is useless, and is not intended to get rid of from category of the present invention other embodiment.
prescription
The pharmaceutical composition of increase bone density of the present invention, is made by the raw material of following weight portion: 150～350 parts of calcium carbonate, 100～250 parts of D-Glucosamine Hydrochlorides, vitamin D
30.2～0.6 part.
In order to send better beneficial effect, i.e. balance between " increasing the curative effect of bone density " and " production cost ", the consumption of raw material is preferably: 200～300 parts of calcium carbonate, 150～200 parts of D-Glucosamine Hydrochlorides, vitamin D
30.3～0.5 part.More preferably: 250 parts of calcium carbonate, 170 parts of D-Glucosamine Hydrochlorides, vitamin D
30.4 part.
preparation method
The pharmaceutical composition of increase bone density of the present invention, can make capsule, tablet etc., and its most preferred dosage form is capsule.
The pharmaceutical composition of increase bone density of the present invention, preparation method is:
A takes D-Glucosamine Hydrochloride, vitamin D according to formula ratio
3and calcium carbonate;
B. by D-Glucosamine Hydrochloride, vitamin D
3mix homogeneously, obtains mixed powder A, standby;
C. calcium carbonate, mixed powder A, right amount of auxiliary materials are put to mix homogeneously in mixer, make capsule and get final product.
The preparation method of its optimum dosage form capsule is:
A takes D-Glucosamine Hydrochloride, vitamin D according to formula ratio
3and calcium carbonate;
B. by D-Glucosamine Hydrochloride, vitamin D
3mix homogeneously, obtains mixed powder A, standby;
C. calcium carbonate, mixed powder A, right amount of auxiliary materials are put to mix homogeneously in mixer, treat that color and luster is consistent, no color differnece, incapsulates, and every dress 0.45g, obtains.
By drug effect, toxicological test, further illustrate advantage of the present invention below.
toxicological test
One, test objective: whether check product has toxicity.
Two, test material:
Sample: embodiment 1 product, content is white powder, intake is 2.70g/60kg.bw. day.
Laboratory animal: SPF level Kunming mouse, Wistar rat.
Experimental animal feeding environment: 20～25 ℃ of temperature, relative humidity 40～70%.
Three, test method:
By its mouse oral acute toxicity test (get embodiment 1 product, with the dosage per os secondary contamination of 20.0g/kg.BW × 2, gavage amount is 0.20ml/10g.BW × 2), rat peroral acute toxicity test (get embodiment 1 product, with the dosage per os secondary contamination of 20.0g/kg.BW × 2, gavage amount is 0.20ml/100g.BW × 2), (test establishes 0.2 to Salmonella reversion test, 0.5, 1.0, 2.5, 5 dosage of 5.0mg/ ware are established blank simultaneously, solvent control and positive control), (adopt 24h twice per os administration by gavage in interval to test, with the positive contrast of cyclophosphamide of 40mg/kg.BW dosage, with the negative contrast of distilled water, 3 dosage of test group are respectively PCEMNR micronucleus test: 2.50, 5.00, 10.00g/kg.BW is subject to test solution to mouse stomach), (with the positive contrast of mitomycin of 2.0mg/kg.BW dosage, with the negative contrast of distilled water, 3 dosage of test group are respectively mouse testis chromosomal aberration test: 2.50, 5.00, 10.00g/kg.BW is subject to test solution to mouse stomach), (get embodiment 1 product, be 2.70 g/60kg.BW according to human body daily intaking amount to 30 days feeding trials, designs three dosage: 1.13g/kg.BW, 2.25 g/kg.BW, 4.50 g/kg.BW, get respectively tested material 169.50g, 337.50g, 675.00g adds normal feedstuff to 15kg, makes piece material and feeds 30 days, with normal feedstuff, feeds negative control group) carry out the evaluation of toxicology test.
Four, result of the test:
1, acute toxicity test: embodiment 1 product is all greater than 20.0g/kg.BW to the large and small Mus per os acute toxicity (MTD) of two kinds of sexes, and according to acute toxicity classification, embodiment 1 product belongs to non-poisonous material.
2, genetic toxicity test:
(1) Salmonella reversion test: result is negative.
(2) PCEMNR nuclear test: result is negative.
(3) mouse testis chromosomal aberration test: result is negative.
Within (4) 30 days, feed: according to the evaluation criterion of 30 days feeding trials in Ministry of Public Health < < health food check and assessment technique standard > > (version in 2003), judge: with 1.13,2.25, the embodiment 1 product content thing of 4.50/kg.BW mixes in feedstuff and feed rat 30 days, at duration of test, each treated animal vegetative activity is good, body weight, weightening finish, food utilization and dirty body ratio and matched group comparison, there are no significant for difference (P > 0.05); Hematological indices, biochemical indicator are all within this detection unit normal range; Gross anatomy no abnormality seen, does not find that the histopathology relevant to given the test agent changes, and this product has no obvious toxic action through 30 days feeding trials.
pharmacological testing
One, test objective: whether check product has the health-care effect that increases bone density
Two, test material:
1. sample: embodiment 1 product, content is white powder, intake is 2.70g/60kg.bw. day.
2. experimental animal: 70 of secondary male Wistar rats, body weight is 52～75g.
3. experimental animal feeding environment: 20～23 ℃ of laboratory temperatures, humidity 44～60%RH.
4. key instrument:
Atomic Absorption Spectrometer, single photon bone density machine, precimeter, zootomy apparatus, one thousandth balance, ten thousand/balance, animal balance, 105 ℃ of baking ovens, digesting.
5. animal grouping:
By recommending consumption to calculate the about 567mg that can replenish the calcium for each person every day, animal is divided into 6 groups at random, i.e. low calcium normal feedstuff group, tested material is low, in, high dose experimental group, 5 times of per kilogram of body weight recommended amounts are equivalent to be respectively grown up, 10 times and 20 times are (according to the average per kilogram of body weight feed of rat 80g, press 0.22g/kg.BW, 0.45g/kg.BW, the dosage of 0.90g/kg.BW is mixed with semisynthetic feed, in feedstuff, the content of tested material is respectively 2.81g/kg, 5.62g/kg, 11.25g/kg), in arranging according to the calcium content of experimental group feedstuff again, high dose calcium carbonate model group.Every group of 10 animals, single cage is fed, ad lib, drink deionized water, weighs, and records food-intake, and be 12 weeks experimental period.
6. the preparation of feedstuff:
Low calcium feed formula (g/kg): casein 100g, the calcium content of analysis for soybean powder 150g, Semen Tritici aestivi flour 540g, Oleum Arachidis hypogaeae semen 40g, cellulose 20g, starch 110g, mixed vitamin 10g, mixed inorganic 26g, DL-methionine 2g, choline chloride 2g, adjustment feedstuff is 1500mg/kg left and right, and in feedstuff, the content of vitamin D is 1000IU/kg.The 1st group is low calcium normal feedstuff group, and the 2nd, 3 groups is dosage and high dose group in calcium carbonate, and the 4th, 5,6 groups is the basic, normal, high dosage experiments group of embodiment 1 product, the feedstuff of every assembly 22kg processed.Wherein:
Low calcium normal feedstuff group: actual measurement per kilogram feedstuff calcium content 1453mg.
Calcium carbonate model group feedstuff:
Middle dosage calcium carbonate group: add calcium carbonate 2.95g/kg in low calcium normal feedstuff, dosage calcium carbonate group feedstuff in preparation, actual measurement per kilogram feedstuff calcium content 2623mg.
High dose calcium carbonate group: add calcium carbonate 5.91g/kg in low calcium normal feedstuff, preparation high dose calcium carbonate group feedstuff, actual measurement per kilogram feedstuff calcium content 3752mg.
The each dosage group of sample feedstuff:
Low dosage tested material experimental group: add tested material 2.81g/kg in low calcium normal feedstuff, preparation sample low dose group feedstuff, actual measurement per kilogram feedstuff calcium content 2100mg.
Middle dosage tested material experimental group: add tested material 5.62g/kg in low calcium normal feedstuff, dosage group feedstuff in preparation sample, actual measurement per kilogram feedstuff calcium content 2650mg.
High dose tested material experimental group: add tested material 11.25g/kg in low calcium normal feedstuff, preparation sample high dose group feedstuff, actual measurement per kilogram feedstuff calcium content 3720mg.
Three, test procedure:
1. growth promoter: rat is after one week laundering period, and sub-cage rearing 12 weeks,, weighs weekly once by 10 every group.
2. femur weight measurement: animal feeding was put to death after 12 weeks, separated a side femur, was baked to constant weight in 105 baking ovens, weighs key heavy.
3. femur density measure: the bone density of measuring femur mid point and femur distal end with single photon bone density machine.
4. the mensuration of calcium content: accurately take tested material sample, animal feed 0.300～1.000, rat one side femur is baked to entirety after constant weight and adopted wet method digestion, with atomic absorption spectroscopy determination calcium content (GB/T5009.92-2003).
5. statistical method: carry out variance analysis check with SPSS10.0for Windows software.
Four, result of the test:
1, the each dosage group of sample and relatively food-intake, calcium intake there was no significant difference of corresponding calcium carbonate model group, in the situation that calcium preparation amount is identical, embodiment 1 product experimental group and the comparison of calcium carbonate model group, there are no significant for the body weight difference of rat (P > 0.05).
2, the femur calcium content (every gram) of basic, normal, high dosage tested material experimental group rat femur length and femur weight and middle and high dosage tested material experimental group rat is higher than low calcium normal feedstuff group, and difference has significance (P < 0.05); Under calcium preparation amount same case, tested material experimental group and the comparison of calcium carbonate model group, femur length, weight and the femur calcium content of middle and high dosage tested material experimental group rat are higher than calcium carbonate model group, and difference has significance (P < 0.05).
3, the bone density of basic, normal, high dosage tested material experimental group rat femur distal end and femur mid point is higher than low calcium normal feedstuff group, and difference has significance (P < 0.05); Under calcium preparation amount same case, tested material experimental group and the comparison of calcium carbonate model group, the bone density of tested material experimental group rat femur distal end and femur mid point is higher than calcium carbonate model group, and there were significant differences (P < 0.05).
The product of conclusion: embodiment 1 has the effect of significant increase bone density with respect to low calcium normal feedstuff group and calcium carbonate control group.
?
Embodiment
The following example has further described and has proved the embodiment in the scope of the invention.These embodiment are only illustrative, but not limit the scope of the invention, because its many modification are possible in the situation that not deviating from the spirit and scope of the invention.
embodiment 1
Formula: calcium carbonate 250g, D-Glucosamine Hydrochloride 170g, vitamin D
30.4g.
Preparation method:
A. according to formula ratio, take D-Glucosamine Hydrochloride, vitamin D
3and calcium carbonate;
B. by D-Glucosamine Hydrochloride, vitamin D
3with equivalent incremental method mix homogeneously, obtain mixed powder A, standby;
C. by calcium carbonate, mixed powder A and starch 26g, magnesium stearate 3.6g, put in mixer and mix 30 minutes, mix homogeneously, mixed powder color and luster is consistent, and no color differnece obtains total mixed powder;
D. by mixed step c total mixed powder filled capsules, every 0.45g, obtains.
embodiment 2
Formula: calcium carbonate 200g, D-Glucosamine Hydrochloride 100g, vitamin D
30.35g.
Preparation method:
A. according to formula ratio, take D-Glucosamine Hydrochloride, vitamin D
3and calcium carbonate;
B. by D-Glucosamine Hydrochloride, vitamin D
3with equivalent incremental method mix homogeneously, obtain mixed powder A, standby;
C. by calcium carbonate, mixed powder A and starch 30g, magnesium stearate 4g, put in mixer and mix 20 minutes, mix homogeneously, mixed powder color and luster is consistent, and no color differnece obtains total mixed powder;
D. by mixed step c total mixed powder filled capsules, every 0.40g.
embodiment 3
Composition of raw materials: calcium carbonate 300g, D-Glucosamine Hydrochloride 150g, vitamin D
30.5g.
Preparation method:
A. according to formula ratio, take D-Glucosamine Hydrochloride, vitamin D
3and calcium carbonate;
B. by D-Glucosamine Hydrochloride, vitamin D
3with equivalent incremental method mix homogeneously, obtain mixed powder A, standby;
C. by calcium carbonate, mixed powder A and starch 25g, magnesium stearate 5g, put in mixer and mix 30 minutes, mix homogeneously, mixed powder color and luster is consistent, and no color differnece obtains total mixed powder;
D. by mixed step c total mixed powder filled capsules, every 0.30g.
embodiment 4
Composition of raw materials: calcium carbonate 350g, D-Glucosamine Hydrochloride 120g, vitamin D
30.6g.
Preparation method:
A. according to formula ratio, take D-Glucosamine Hydrochloride, vitamin D
3and calcium carbonate;
B. by D-Glucosamine Hydrochloride, vitamin D
3with equivalent incremental method mix homogeneously, obtain mixed powder A, standby;
C. by calcium carbonate, mixed powder A and starch 35g, magnesium stearate 6g, put in mixer and mix 35 minutes, mix homogeneously, mixed powder color and luster is consistent, and no color differnece obtains total mixed powder;
D. by mixed step c total mixed powder filled capsules, every 0.35g.
embodiment 5
Composition of raw materials: calcium carbonate 150g, D-Glucosamine Hydrochloride 250g, vitamin D
30.2g.
Preparation method is:
A. according to formula ratio, take D-Glucosamine Hydrochloride, vitamin D
3and calcium carbonate;
B. by D-Glucosamine Hydrochloride, vitamin D
3with equivalent incremental method mix homogeneously, obtain mixed powder A, standby;
C. by calcium carbonate, mixed powder A and starch 10g, magnesium stearate 3g, put in mixer and mix 40 minutes, mix homogeneously, mixed powder color and luster is consistent, and no color differnece obtains total mixed powder;
D. by mixed step c total mixed powder filled capsules, every 0.38g.
embodiment 6
Composition of raw materials: calcium carbonate 280g, D-Glucosamine Hydrochloride 200g, vitamin D
30.3g.
Preparation method:
A. according to formula ratio, take D-Glucosamine Hydrochloride, vitamin D
3and calcium carbonate;
B. by D-Glucosamine Hydrochloride, vitamin D
3mix homogeneously, obtains mixed powder A, standby;
C. calcium carbonate, mixed powder A and starch 40g, magnesium stearate 2g are put in mixer and mixed 50 minutes, mix homogeneously, mixed powder color and luster is consistent, and no color differnece obtains total mixed powder;
D. by mixed step c total mixed powder filled capsules, every 0.50g.
Claims (6)
1. a pharmaceutical composition that increases bone density, is characterized in that, by the raw material of following weight portion, is made: 150～350 parts of calcium carbonate, 100～250 parts of D-Glucosamine Hydrochlorides, vitamin D
30.2～0.6 part.
2. the pharmaceutical composition that increases according to claim 1 bone density, is characterized in that, by the raw material of following weight portion, is made: 200～300 parts of calcium carbonate, 150～200 parts of D-Glucosamine Hydrochlorides, vitamin D
30.3～0.5 part.
3. the pharmaceutical composition that increases according to claim 1 bone density, is characterized in that, by the raw material of following weight portion, is made: 250 parts of calcium carbonate, 170 parts of D-Glucosamine Hydrochlorides, vitamin D
30.4 part.
4. according to the pharmaceutical composition of arbitrary described increase bone density in claim 1～3, it is characterized in that, described pharmaceutical composition is made capsule or tablet.
5. as a preparation method for pharmaceutical composition as described in arbitrary in claim 1～3, it is characterized in that, comprise the steps:
A. according to formula ratio, take D-Glucosamine Hydrochloride, vitamin D
3and calcium carbonate;
B. by D-Glucosamine Hydrochloride, vitamin D
3mix homogeneously, obtains mixed powder A, standby;
C. calcium carbonate, mixed powder A, right amount of auxiliary materials are put to mix homogeneously in mixer, make preparation, obtain.
6. the preparation method of pharmaceutical composition according to claim 5, is characterized in that D-Glucosamine Hydrochloride, vitamin D in described step b
3mixing be to adopt equivalent incremental method mix homogeneously.
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|---|---|---|---|
| CN201310715610.5A CN103720710A (en) | 2013-12-23 | 2013-12-23 | Pharmaceutical composition capable of increasing bone density and preparation method of pharmaceutical composition |
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Family
ID=50445172
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN106109490A (en) * | 2016-08-02 | 2016-11-16 | 辽宁康辰药业有限公司 | One increases bone density, prevents and treats osteoporotic tablet and preparation method thereof |
| CN108685943A (en) * | 2018-07-19 | 2018-10-23 | 深圳极醇健康产业股份有限公司 | A kind of tablet and preparation method thereof increasing bone density |
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| US20050008699A1 (en) * | 2003-07-11 | 2005-01-13 | Fred Wehling | Effervescent glucosamine composition |
| CN1695634A (en) * | 2004-05-10 | 2005-11-16 | 北京扬新科技有限公司 | Combination of medication and health products for preventing and treating osteoporosis and osteoarthritis, and preparation method |
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| US20050008699A1 (en) * | 2003-07-11 | 2005-01-13 | Fred Wehling | Effervescent glucosamine composition |
| CN1695634A (en) * | 2004-05-10 | 2005-11-16 | 北京扬新科技有限公司 | Combination of medication and health products for preventing and treating osteoporosis and osteoarthritis, and preparation method |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN106109490A (en) * | 2016-08-02 | 2016-11-16 | 辽宁康辰药业有限公司 | One increases bone density, prevents and treats osteoporotic tablet and preparation method thereof |
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Application publication date: 20140416 |