CN109906084A - A kind of replenish the calcium composition and its application reducing hypercalcemia risk - Google Patents
A kind of replenish the calcium composition and its application reducing hypercalcemia risk Download PDFInfo
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Abstract
A kind of replenish the calcium composition and its application reducing hypercalcemia risk.The composition further includes kudzu root extract and eucommia leaf extract in addition to containing aminoglucose hydrochloride and calcium carbonate, and the weight ratio of two kinds of extracts is 4: 1~1.2: 1.The composition can be effectively improved bone metabolism, increase bone density, reduce hypercalcemia risk.
Description
The present invention relates to a kind of compositions, more particularly to a kind of composition for reducing adverse reaction while replenishing the calcium.
Osteoporosis is reduced with bone amount, bone tissue microstructure degeneration, bone trabecula attenuates, it is short split, quantity is reduced, cortex becomes feature so that the brittleness of bone increases, be easy to happen a kind of systemic skeletal disease of fracture.It is reported that vertebral fracture, Hip Fracture and Wrist fracture account for about 3/4 in osteoporotic fracture.In the fracture patient of the postmenopausal women in the U.S., vertebral fracture accounts for 25%, and up to 35% when by 75 years old.Someone counts, and in the osteoporotic fracture in China, Hip Fracture accounts for 21.41%；Wherein there are about in fracture patient 1 year of 20% because be unable to leave the bed cause complication due to it is dead.And in the high disease of the common incidence of several women, including myocardial infarction, cerebral apoplexy, breast cancer etc., wherein osteoporotic fracture incidence ranks the umber one.
Bone density is an important symbol of bone mass, is reflection osteoporosis degree, predicts the important evidence of fracture risk.Increase bone density, effectively treat the important topic that osteoporosis has become people's extensive concern.
Osteoporosis can effectively be prevented or treat by replenishing the calcium.Existing listing is replenished the calcium and in the product of Saving cortilage mostly containing Glucosamine and calcium carbonate.Glucosamine can promote the synthesis of human body mucopolysaccharide, improve the viscosity of knuckle synovia, improve the metabolism of articular cartilage.Calcium carbonate can supplement that skeleton is necessary calcareous as calcium source, be the effective component of pre- preventing bone rarefaction.
Studies have found that Glucosamine and calcium carbonate can produce some adverse reactions after long-term use.How the effect of traditional calcium supplementing product is preferably played, while can reduce adverse reaction is the problem of being worth further investigation.
Summary of the invention
In being studied, inventors be surprised to learn that: the combination of kudzu root extract and eucommia leaf extract can reduce the adverse reaction of common calcium supplementing product.
In a first aspect, it further includes kudzu root extract and eucommia leaf extract in the composition that active constituent, which includes aminoglucose hydrochloride and calcium carbonate, the present invention provides a kind of composition for increasing bone density.
Glucosamine is the main component of cartilage matrix.Supplement Glucosamine can increase organic in bone
Content of material inhibits bone matrix degradation to destroy, can Saving cortilage cartilage, have good effect to the symptoms such as arthralgia caused by osteoporosis are improved.Aminoglucose hydrochloride is a kind of its salt form, can pass through commercially available acquisition.
Calcium carbonate is the common medicine replenished the calcium, and can pass through commercially available acquisition.
Pueraria lobata is the dry root of legume pueraria lobata (Puerarialobata (Willd.) Ohwi), has and improves immune, antipyretic, protect liver, improves cardiovascular and cerebrovascular disease and other effects.Kudzu root extract is the extract that pueraria lobata is extracted through conventional method, can also pass through commercially available acquisition.
Folium cortex eucommiae is the dried leaf of Eucommiaceae plant Cortex Eucommiae (EucommiaulmoidesOliver).Traditional Chinese medicine Cortex Eucommiae is then the drying skin of Cortex Eucommiae.Some researches show that folium cortex eucommiae has kidney tonifying, strengthening the muscles and bones and other effects.Eucommia leaf extract is the extract that folium cortex eucommiae is extracted through conventional method, can also pass through commercially available acquisition.
By the study found that long-term use glucosamine salt hydrochlorate and calcium carbonate may cause some adverse reactions, such as the increase of hypercalcemia risk later.Hypercalcinemia shows as the abnormal of serum ion calcium concentration and increases, generally greater than 2.75mmol/L.The many factors such as drug, disease can cause hypercalcemia, and hypercalcemia symptom can cause the multisystem diseases such as digestion, movement, nerve, uropoiesis, such as anorexia, Nausea and vomiting, constipation, out of strength, muscular fatigue, hypomyotonia, it is tired drink, diuresis, it is drowsiness, clouded in mind, or even stupor etc..Hypercalcemia itself belongs to the disorder of calcium metabolism, and calcium supplementing product affects human body calcium metabolism, therefore there are the risks of hypercalcemia by the direct intake of the extraneous calcium of increase.
And it was unexpectedly observed that kudzu root extract and this adverse reaction can be reduced with the combination of eucommia leaf extract.
The ratio of kudzu root extract and eucommia leaf extract is very crucial for the adverse reaction for reducing traditional calcium supplementing product.When in certain specific proportional regions, significant improvement is can be obtained in the adverse reaction of aminoglucose hydrochloride and calcium carbonate.In the present invention, it is preferred to which the weight ratio of kudzu root extract and eucommia leaf extract is 4:1~1.2:1.It is highly preferred that the weight ratio of the two is 3:1~1.5:1.
The weight percentage of kudzu root extract and eucommia leaf extract can be 2-30% in composition.
The content of aminoglucose hydrochloride and calcium carbonate in composition can use usual amounts.For example, the weight percentage of aminoglucose hydrochloride can be 20-50%, the weight percentage of calcium carbonate can be 20-50%.
Above-mentioned composition of the invention can be only grouped as by four kinds of kudzu root extract, eucommia leaf extract, aminoglucose hydrochloride and calcium carbonate groups, can also be contained auxiliary material, in addition can also be added in other active materials and form compound.
Preferably, kudzu root extract, eucommia ulmoides extracts, Glucosamine, calcium carbonate in above-mentioned composition
Weight ratio be about 1.09-24:0.4-13.64:20-50:20-50.
Second aspect, the present invention provides a kind of compound for increasing bone density, which contains the composition in the present invention.
Preferably, compound of the invention can contain applicable auxiliary material, such as diluent, binder, lubricant etc., specific such as microcrystalline cellulose, starch, lactose, talcum powder, magnesium stearate.
Preferably, compound of the invention can also contain other active components in addition to containing the above-mentioned composition in the present invention.It is further preferred that other described active components can be selected from one of chondroitin sulfate, Shorthorned Epimedium P.E or Rhizoma Drynariae extract or a variety of.
Chondroitin sulfate is the acid mucopolysaccharide that preparation is extracted from animal tissue, it can remove a large amount of Na+ absorbed in synovial membrane, sclerotin is promoted to increase, repair impaired joint, it can enhance absorption of the articular cartilage to nutrition, cartilage cell can also be made to have enough moisture, so as to have the function that damping vibration and lubrication.The weight percentage of chondroitin sulfate can be 8-30% in compound of the invention.
Herba Epimedii (Epimediumbrevicornu Maxim.) belongs to Berberidaceae Epimedium.With bone cell function is inhibited, especially increase calcification bon e formation, there is " Psoralen " effect.The weight percentage of Shorthorned Epimedium P.E can be 2-15% in compound of the invention.
The rhizome of davallia (Davalliamariesii Moore ex Bak.) is the dry rhizome of Plants of Polypodiaceae Mongolian oak fern, has cure the wound analgesic, The strong bone of kidney tonifying and other effects.The weight percentage of Rhizoma Drynariae extract can be 2-15% in compound of the invention.
Above-mentioned composition or compound of the invention can according to need the different form that is prepared into, such as capsule, tablet.
The third aspect, the present invention also provides application of the combination of kudzu root extract and eucommia leaf extract in the adverse reaction for mitigating drug or health care product.
Preferably, the weight ratio of kudzu root extract and eucommia leaf extract is 4:1~1.2:1；Further preferably 3:1~1.5:1.
Preferably, above-mentioned adverse reaction includes hypercalcinemia.
Preferably, the function of above-mentioned drug or health food includes increasing bone density.
Preferably, aminoglucose hydrochloride and calcium carbonate are contained in above-mentioned drug or health food.
Composition and compound of the invention has effects that traditional calcium supplementing product, can such as be effectively improved bone metabolism, increases bone density, reinforces Bones and joints, hence it is evident that the problems such as solving osteoporosis and impaired Bones and joints.It is more important
, composition and compound of the invention can significantly reduce hypercalcemia risk, and not generate new adverse reaction.This for need for a long time replenish the calcium and physical function it is poor mid-aged population it is particularly suitable.
The present invention is described below with reference to specific embodiments.It will be appreciated by those skilled in the art that these embodiments are merely to illustrate the present invention, do not limit the scope of the invention in any way.
Experimental method in following embodiments is unless otherwise specified conventional method.Supplementary material, reagent material used etc. are commercially available products unless otherwise specified.
Embodiment 1
Prepare existing composition of replenishing the calcium.1080g calcium carbonate and 626g aminoglucose hydrochloride are weighed respectively, after two kinds of raw materials are crossed 40 meshes, is uniformly mixed, mixture is taken to be slowly added into above funnel, and the test sample leaked out from funnel bottom forms the inclination angle of coniform accumulation body in the horizontal plane.The diameter and height that cone is measured with ruler precision find out tiltangleθ with formula tan θ=h/r.Every kind of formula measures angle of repose three times, measurement result angle of repose≤40 ° after, powder is directly filled into capsule 6000 after raw material is mixed.
Embodiment 2
Increase eucommia leaf extract and kudzu root extract on the basis of 1 prescription of embodiment, prepares kudzu root extract: eucommia leaf extract=6:1 composition.1080g calcium carbonate, 626g aminoglucose hydrochloride, 66g eucommia leaf extract and 388g kudzu root extract are weighed respectively, according to the preparation method of embodiment 1, are prepared into capsule 6000.
Embodiment 3
Prepare kudzu root extract: composition eucommia leaf extract=1.2:1 of the invention.929g calcium carbonate, 756g aminoglucose hydrochloride, 19.6g eucommia leaf extract, 23.6g kudzu root extract, 421g microcrystalline cellulose, 10.8g magnesium stearate are weighed respectively.According to the preparation method of tablet, softwood processed is pelletized, and tabletting obtains 6000.
Embodiment 4
Prepare kudzu root extract: composition eucommia leaf extract=2:1 of the invention.820.8g calcium carbonate, 432g aminoglucose hydrochloride, 108g eucommia leaf extract, 216g kudzu root extract and 583.2g microcrystalline cellulose are weighed respectively.According to the preparation method of embodiment 1, it is prepared into capsule 6000.
Embodiment 5
Prepare kudzu root extract: composition eucommia leaf extract=1.5:1 of the invention.432g is weighed respectively
Calcium carbonate, 1080g aminoglucose hydrochloride, 51.8g eucommia leaf extract, 77.8g kudzu root extract and 518.4g microcrystalline cellulose.According to the preparation method of embodiment 1, it is prepared into capsule 6000.
Embodiment 6
Prepare kudzu root extract: composition eucommia leaf extract=4:1 of the invention.518.4g calcium carbonate, 993.6g aminoglucose hydrochloride, 129.6g eucommia leaf extract and 518.4g kudzu root extract are weighed respectively.According to the preparation method of embodiment 1, it is prepared into capsule 6000.
Embodiment 7
Prepare kudzu root extract: composition eucommia leaf extract=3:1 of the invention.1080g calcium carbonate, 626.4g aminoglucose hydrochloride, 113.4g eucommia leaf extract and 340.2g kudzu root extract are weighed respectively.According to the preparation method of embodiment 1, it is prepared into capsule 6000.
Embodiment 8
Prepare kudzu root extract: eucommia leaf extract=1:1 composition.1080g calcium carbonate, 626g aminoglucose hydrochloride, 227g eucommia leaf extract and 227g kudzu root extract are weighed respectively.According to the preparation method of embodiment 1, it is prepared into capsule 6000.
Embodiment 9
Chondroitin sulfate, Shorthorned Epimedium P.E, Rhizoma Drynariae extract isoreactivity substance are increased on the basis of the present composition, prepare compound of the invention.1080g calcium carbonate, 626g aminoglucose hydrochloride, 113g eucommia leaf extract, 340g kudzu root extract, 1080g chondroitin sulfate, 72g Shorthorned Epimedium P.E and 289g Rhizoma Drynariae extract are weighed respectively.According to the preparation method of embodiment 1, it is prepared into capsule 6000.
Embodiment 10
Prepare compound of the invention.1080g calcium carbonate is weighed respectively, 626g aminoglucose hydrochloride, 113g eucommia leaf extract, 340g kudzu root extract, 243.9g chondroitin sulfate, 304.2g Shorthorned Epimedium P.E, 304.2g Rhizoma Drynariae extract and 30.6g magnesium stearate are prepared into capsule 6000 according to the preparation method of embodiment 1.
Embodiment 11
Prepare compound of the invention.1080g calcium carbonate, 626g aminoglucose hydrochloride, 113g eucommia leaf extract are weighed respectively, 340g kudzu root extract, 685.7g chondroitin sulfate, 515.3g Shorthorned Epimedium P.E and 69g Rhizoma Drynariae extract, according to the preparation method of embodiment 1, it is prepared into capsule 6000.
Embodiment 12
Prepare compound of the invention.1080g calcium carbonate, 626g aminoglucose hydrochloride, 113g eucommia leaf extract are weighed respectively, 340g kudzu root extract, 515.3g chondroitin sulfate, 240g Shorthorned Epimedium P.E and 514.3g Rhizoma Drynariae extract, according to the preparation method of embodiment 1, it is prepared into capsule 6000.
Embodiment 13
Each composition of Examples 1 to 9 is observed in removal ovary osteoporosis (OP) rat model on bone density and hematological influence.
1, it is grouped and handles:
Take 10 monthly age SD female rats 110, rat is randomly divided into 11 groups, every group 10, i.e. sham-operation group, model control group, example 1 group, 2 groups of embodiment, 3 groups of embodiment, 4 groups of embodiment, 5 groups of embodiment, 6 groups of embodiment, 7 groups of embodiment, 8 groups of embodiment, 9 groups of embodiment.3% yellow Jackets intraperitoneal anesthesia of sham-operation group takes back side two incision by lumbar vertebrae to enter abdominal cavity under strict aseptic technique, and after extracing a little mesostenium, carefully stop blooding layer-by-layer suture notch.Model control group and embodiment 1-9 group, anesthesia are same as above, and under strict aseptic technique, take back side two incision by lumbar vertebrae, and into abdominal cavity back side, after complete excision bilateral ovaries, carefully stop blooding layer-by-layer suture notch.
Postoperative three days, sham-operation group and model control group were with distilled water stomach-filling.Example 1 group gives the composition 28.4mg/kg.bw in embodiment 1, and embodiment 2-8 group respectively correspondingly gives the composition 36mg/kg.bw in embodiment 2-8,9 groups of the embodiment composition 60mg/kg.bw given in embodiment 9.All animal stomach-filling amounts are 10ml/kg.bw, once a day, continuous gavage 90 days.
2, testing index:
Before experiment, experiment in and experiment after record animal weight.After the end of the experiment, after taking blood to all rat tails, blood is instilled in 1.5mL centrifuge tube, and serum is placed on ice after standing 0.5 hour at room temperature, continues to stand 1 hour.Centrifuge tube is taken out, is centrifuged at room temperature with 4000~6000rpm 3~5 minutes, every 600 μ L whole blood takes 200~300 μ L serum.After disposable absorption, the serum of acquirement is dispensed into sterilized centrifuge tube, carries out blood calcium determination.The each group blood calcium value that is averaged is as shown in table 2.Euthanasia animal after the completion of blood is taken, bilateral femur is taken out, right side femur is placed in 105 DEG C of baking ovens, is baked to constant weight, is weighed bone weight, measures left femur bone density using the full-automatic high-resolution X-ray machine of toy.Influence of each group to bone density is as shown in table 1.
3, experimental result:
1 each group rat body weight of table and femur weight and bone density count
According to data in table, each group weight obviously increases before relatively testing after experiment.Compared with sham-operation group, model group body weight increases especially pronounced (P < 0.01), and bone density is substantially reduced (P < 0.01), illustrates modeling success.Compared with model group, embodiment 1-9 group femur weight and bone density are all improved, even if only containing calcium carbonate and aminoglucose hydrochloride in example 1 group, but also the bone weight of rat after the test is increased with bone density, illustrate that the rat bone weight that bilateral ovaries have been picked-off after taking composition of the invention and bone density are increased.Composition of the invention effectively can prevent and improve osteoporosis.
The average blood calcium Data-Statistics result of 2 each group rat of table
| Group | Average blood calcium value (mmol/L) |
| Sham-operation group | 2.48±0.07 |
| Model control group | 2.43±0.08 |
| Example 1 group | 3.07±0.12 |
| 2 groups of embodiment | 2.97±0.08 |
| 3 groups of embodiment | 2.51±0.06 |
| 4 groups of embodiment | 2.53±0.05 |
| 5 groups of embodiment | 2.46±0.07 |
| 6 groups of embodiment | 2.50±0.09 |
| 7 groups of embodiment | 2.47±0.05 |
| 8 groups of embodiment | 3.00±0.11 |
| 9 groups of embodiment | 2.44±0.07 |
Normal blood calcium level is 2.25-2.75mmol/L, is experimentally observed Some Animals and blood calcium raising occurs, and some is up to 3mmol/L or more, prompts the hypercalcinemia for light moderate occur.But sham-operation group and model control group do not occur blood calcium raising, and showing modeling process not is to lead to hypercalcinemia Producing reason.It can be seen that influence of the present composition to experimental animal blood calcium from the comparison of each embodiment group.Example 1 group is the composition without eucommia leaf extract and kudzu root extract, and 2~embodiment of embodiment 9 contains above two extract.2 data of table show, example 1 group, 2 groups and 8 groups rats average calcium level be apparently higher than sham-operation group and model control group, after illustrating the composition of replenishing the calcium by taking example 1 group, 2 groups and 8 groups, the phenomenon that rat produces hypercalcinemia.The average calcium level of 9 rat of 3~embodiment of embodiment 7 and embodiment is suitable with sham-operation group and model control group, and substantially less than example 1 group, 2 groups and 8 groups (P < 0.01).The above results show that the addition of the eucommia leaf extract and kudzu root extract composition that can effectively prevent to replenish the calcium leads to the adverse reaction of hypercalcinemia, and when the two is within the scope of special ratios, can generate significant good effect.
Embodiment 14
Toxicological experiment is carried out using composition prepared by the embodiment 3 in the present invention, as the result is shown: in acute toxicity testing, SD rat acute MTD is greater than 15g/kg.bw, is classified according to acute toxicity, belongs to nontoxic grade.In genetic toxicity test, Salmonella reversion test, mice bone marrow micronucleus and mouse inbred strain result are feminine gender.In 30 days feeding trials, maximum dose level is 100 times of human body recommended intake, does not cause the anomalous variation of every important indicator such as rat holistic health, biochemical functions and organ-tissue morphology.These results suggest that composition of the invention does not generate new toxicity, safety is good.
Although above the present invention is described in detail with a general description of the specific embodiments, on the basis of the present invention, it can be made some modifications or improvements, this will be apparent to those skilled in the art.Therefore, these modifications or improvements without departing from theon the basis of the spirit of the present invention, fall within the scope of the claimed invention.
The present invention relates to a kind of replenish the calcium composition and its application for reducing hypercalcemia risk, the present composition can be applied alone, and the substance that can also replenish the calcium with other is used together.Composition and compound of the invention can be effective
Improve bone metabolism, increase the problems such as bone density, obvious solution osteoporosis and Bones and joints are damaged.It is minimized hypercalcemia risk, and does not generate new adverse reaction, the mid-aged population degenerated especially suitable for physical function and need to replenish the calcium for a long time.The present invention has broad application prospects and good industrial applicibility in pharmaceutical technology field.
Claims (10)
- A kind of composition of replenishing the calcium reducing hypercalcemia risk, its active constituent includes aminoglucose hydrochloride and calcium carbonate, it is characterized in that, further including kudzu root extract and eucommia leaf extract in the composition, the weight ratio of the kudzu root extract and eucommia leaf extract is 4:1~1.2:1.
- Composition according to claim 1, which is characterized in that the weight ratio of the kudzu root extract and eucommia leaf extract is 3:1~1.5:1.
- Composition according to claim 1, which is characterized in that the composition is made of aminoglucose hydrochloride, calcium carbonate, kudzu root extract and eucommia leaf extract.
- A kind of compound of replenishing the calcium reducing hypercalcemia risk, which is characterized in that contain composition as claimed in any one of claims 1-3.
- Compound according to claim 4, which is characterized in that also containing applicable auxiliary material in the compound.
- Compound according to claim 4, which is characterized in that also contain other active components in the compound.
- Compound according to claim 6, which is characterized in that other described active components are selected from one of chondroitin sulfate, Shorthorned Epimedium P.E or Rhizoma Drynariae extract or a variety of.
- Application of the combination of kudzu root extract and eucommia leaf extract in the adverse reaction for mitigating drug or health food.
- Application according to claim 8, which is characterized in that the function of the drug or health food includes increasing bone density.
- Application according to claim 8, which is characterized in that the adverse reaction includes hypercalcinemia.
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| PCT/CN2016/109473 WO2018107324A1 (en) | 2016-12-12 | 2016-12-12 | Calcium supplement composition for decreasing risk of hypercalcemia and use thereof |
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| CN109601880B (en) * | 2018-12-10 | 2022-06-24 | 金木集团有限公司 | Health food for increasing bone mineral density |
| CN112352894A (en) * | 2020-11-02 | 2021-02-12 | 山东贝隆杜仲生物工程有限公司 | Nutritious food prepared from Eucommiae cortex for improving bone density of astronaut, and its application |
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2016
- 2016-12-12 WO PCT/CN2016/109473 patent/WO2018107324A1/en active Application Filing
- 2016-12-12 CN CN201680090514.8A patent/CN109906084B/en active Active
Patent Citations (4)
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| CN101167783A (en) * | 2007-11-09 | 2008-04-30 | 孙文基 | Application of total glycosides of eucommia ulmoides in preparing medicine for treating osteoporosis |
| CN102670696A (en) * | 2012-05-03 | 2012-09-19 | 中国药科大学 | Eucommia ulmoids leaf extracts and preparation method and application thereof |
| CN104431684A (en) * | 2014-11-30 | 2015-03-25 | 邵素英 | Health product for increasing bone density and preparation method of health product |
| CN105639620A (en) * | 2015-12-29 | 2016-06-08 | 崔俊昌 | Health food composition for increasing bone mineral density, and preparation method thereof |
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| Title |
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| FU XIAO-MING等: "Synergistic effect of total isoflavones of pueraria and vitamin D on prevention and treatment of osteoporosis", 《中国组织工程研究与临床康复》 * |
| 李妮等: "葛根提取物对去卵巢大鼠血液指标的影响", 《实用药物与临床》 * |
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| WO2018107324A1 (en) | 2018-06-21 |
| CN109906084B (en) | 2023-03-31 |
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