CN100496513C - Bone density-increasing and senility-postponing capsule formulation - Google Patents

Bone density-increasing and senility-postponing capsule formulation Download PDF

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Publication number
CN100496513C
CN100496513C CNB200510029989XA CN200510029989A CN100496513C CN 100496513 C CN100496513 C CN 100496513C CN B200510029989X A CNB200510029989X A CN B200510029989XA CN 200510029989 A CN200510029989 A CN 200510029989A CN 100496513 C CN100496513 C CN 100496513C
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China
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micropowder
capsule
calcium carbonate
bone density
vitamin
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CNB200510029989XA
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CN1762386A (en
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金昭英
姚笃卿
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SHANGHAI BEST HEALTH PRODUCT CO Ltd
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SHANGHAI BEST HEALTH PRODUCT CO Ltd
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Abstract

The present pertains to the field of traditional Chinese medicine, more specifically a capsule for increasing compact bone substance density and delaying senescence, which is prepared from soybean isoflavones, shark cartilage micropowder, calcium carbonate, vitamin B6, folic acid and medicinal auxiliary materials.

Description

The capsule preparations of a kind of bone density improving and deferring senility
Technical field
The invention belongs to the field of Chinese medicines, be specifically related to a kind of control causes osteoporosis, women's aging, climacteric syndrome because of estrogen deficiency and/or estrogen exhaustion capsule preparations.
Background technology
Estrogen has the physiological function of keeping female sex organ and secondary sexual characteristics, participates in the physiological activity of each tissue system of health.The women steps into the middle age, climacteric, gonad function was failed gradually to old, and the secretion of body inner estrogen reduces even be exhausted, health produces a series of variations and symptom, comprise cryptorrhea, metabolism disorder, cardiovascular system pathological changes, osteoporosis, urinary tract infection, skin aging, senile vaginitis, and climacteric syndrome such as autonomic nervous system disorder, be the able-bodied main root of puzzlement middle aged and aged women.Treat these diseases, the most frequently used and effective method is Hormone Replacement Therapy (HRT), promptly gives low dose of estrogen (mainly being estradiol), prevention and alleviation climacteric syndrome.But clinical practice is found, uses the danger that estrogen may increase carcinoma of endometrium, breast carcinoma generation, and user has a misgiving.Exploitation pure natural plants estrogen mainly is soybean isoflavone, and the symptom of control estrogen deficiency is subjected to showing great attention to of domestic and international medical and health and sociology aspect, is the research focus of field of health care products.
Summary of the invention
The capsule preparations that the purpose of this invention is to provide a kind of bone density improving and deferring senility.Capsule preparations of the present invention can be prevented and treated bone loss, osteoporosis, and women's aging and climacteric syndrome, its health-care effect is good, no toxicity, the quality of life that helps improving middle aged and aged women.
Compound capsule of the present invention by soybean isoflavone wherein isoflavone content in 35%-43% scope, shark cartilage micropowder, calcium carbonate, vitamin B 6, folic acid adds the medicine adjuvant and makes (trade name: phoenix English capsule).
Described soybean isoflavone is a phytoestrogen, comprise ten surplus kind of chemical compound, its similar is in estrogen, combines with estrogen receptor and plays a role, its intensity is 1 * 10 of estradiol -3To 1 * 10 -5Doubly, with receptor to combine speed more faster than estrogen, do not have the side effect of steroid hormone, find no carcinogenic probability.Bone and its cells is cultivated and to be shown, soybean isoflavone can be directly by the differentiation of osteoclast before suppressing, or osteoclast is reacted the heavy absorption function of the bone that suppresses osteoclast to parathyroid hormone before suppressing.
The test of removal ovary rat animal model shows, the oral soybean isoflavone 0.712-1.424mmol/kgd of rat, and 25 days, to compare with matched group, mononuclear cell or multinucleated osteoclast increase and reduce, and Histological parameter shows that also bone heavily absorbs decline.
After the menopause or the clinical research result of senile osteoporosis treatment, early stage at natural menopause, give the soybean isoflavone of 600mg/d and the calcium of 1g/d, the matched group list is given calcium, results suggest, soybean isoflavone has the trend that strengthens the lumbar vertebra mineral content, and (itself can not strengthen 0.3mg/d estrogen if give a small amount of estrogen simultaneously Bone density), can significantly strengthen postmenopausal women's bone density.
Menopausal women normal with the bone amount or that lower is an object, divides four groups to give 84mg/d, 126mg/d, placebo and estrogen replacement therapy.Followed the trail of for 24 weeks, measure lumbar vertebra, neck of femur and test front and back, Ward ' s trigonum bone density, the result: soybean isoflavone 84-126mg/d can slow down the menopausal women bone loss, and it is relatively stable to keep bone density, and its produce effects amount is 126mg/d.
Soybean isoflavone is intravital antioxidant, and to antioxidant radical and lipid peroxidation, it also can induce the activity of antioxidase, reduce DNA and cell and sustain damage, and protection cell and organ, thereby play function in delaying senility.In addition, soybean isoflavone is prevented and treated the function of cardiovascular and cerebrovascular disease such as atherosclerosis, hyperlipidemia etc. in addition.
Shark cartilage powder contains more organic calcareous, soybean isoflavone exist with effect under, be absorbed by the body easily.Shark cartilage powder contains abundant polysaccharide, and as mucopolysaccharide, chondroitin sulfate, these polysaccharide can effectively improve immune function of human body, and health invigorating has deferring senility.It also has scavenging action to reactive oxygen free radical, prevents cell inactivation and sudden change, plays delaying senility function.
Calcium carbonate is the calcium source, under the existence and effect of soybean isoflavone, is absorbed by the body easily.
Soybean isoflavone of the present invention is available from North China drugmaker; Described shark cartilage powder is for buying behind the shark cartilage by the known method processing and preparing; All the other supplementary materials are commercial.
Preparation of the present invention is made (daily dose) by the component of following weight proportion:
Soybean isoflavone, 0.15-0.5g
Shark cartilage micropowder 0.3-0.7g
Ground calcium carbonate 0.5-0.8g
Vitamin B 62mg
Folic acid 0.2mg
Micropowder silica gel 2-8mg
Magnesium stearate 1-5mg
Preparation of the present invention is made capsule by following preparation method,
Get each component by above-mentioned weight:
Soybean isoflavone, isoflavone content is in 35%-43% scope;
Get dry shark pygostyle, selected back chopping, the mill coarse powder is ground into granularity 200 orders-300 order micropowder, sealing, sterilization, the shark cartilage micropowder;
Ground calcium carbonate is made binding agent with sodium carboxymethyl cellulose, makes fine grained;
Above-mentioned three kinds of raw materials are fine powder, are not suitable for the production of capsule loading machine, make fluidizer so add an amount of micropowder silica gel, and magnesium stearate is made antiplastering aid, and ground calcium carbonate is made binding agent with sodium carboxymethyl cellulose, makes fine grained separately.Above-mentioned mixing of materials is even, through the powder mobility-detected, and cloud test, the capsule loading machine is loaded capsule automatically.
Described capsule, every day, dosage was distributed into four capsules, loading amount 360mg/.
Usage and consumption: every day secondary, each two.
Capsule of the present invention can be used as health product and takes for a long time, and can take in soybean isoflavone 80-100mg every day, replenishes calcium amount 200-350mg simultaneously.
Capsule of the present invention has carried out the toxicity detection, and the result shows: free of toxic effects.
1, acute toxicological experiment: LD 50The 21.5g/kg body weight;
2, Ames experiment: not seeing has mutagenic action;
3, mouse sperm deformity experiment: not finding has mutagenic action to sexual cell in vivo;
4, mouse bone marrow cells micronucleus test: do not find bone marrow cells in mice is caused the chromosome breakage effect;
5, rat 30 days is fed experiment: to rat ingest, index inspections such as body weight gain, hemoglobin, red blood cell count(RBC), numeration of leukocyte, glutamate pyruvate transaminase, glutamic oxaloacetic transaminase, GOT, blood urea nitrogen, cholesterol, triglyceride, albumin, globulin, glucose, all no abnormal, pathological change is not found in the histopathology check yet.
Rat increases bone density function test result and shows: the bone density improving effect is arranged.
Basic, normal, high three dosage groups are established in experiment: each organizes feedstuff calcic 1500,3000,5000mg/kg respectively, sets up three matched groups simultaneously: basic, normal, high calcium matched group (difference calcic 800,3000,5000mg/kg in the feedstuff).Experimental result shows: each dosage group rat body weight of sample, height and corresponding control rats relatively do not have significant difference; Dot density all is significantly higher than low calcium matched group in the weight of high, middle dosage group femur, femur length, femur metaphysis bone density, the femur.Preparation calcium content of the present invention is 21.8%, and the human body recommended amounts is 1.44g/60kg body weight every day.
The test of animal deferring senility:
Aged mouse-anti oxidimetry result shows: middle dosage group rat blood serum lipid peroxide catabolite malonaldehyde (MDA) content significantly is lower than matched group (P<0.05), and with age group there was no significant difference in March (P〉0.05), show that this present invention preparation has stronger reduction lipid peroxidation; Low dose group, middle dosage group and high dose group rat blood serum superoxide dismutase (SOD) vigor show that apparently higher than matched group (P<0.05) preparation of the present invention has the increased SOD effect.
The drosophila survival result of the test shows: female fruit bat of 0.432% concentration group and matched group relatively show to prolong average life 4.5 days that the demonstration of 0.48%, 0.144% and 0.432% concentration group prolongs female fly average life 1.9-4.5 days (P<0.05); 0.016%, male fly of 0.048% and 0.144% concentration group and matched group relatively show to prolong average maximum life span 6.2-8.6 days (P<0.05).The result shows: preparation of the present invention has delaying senility function.
The specific embodiment
Embodiment 1
Take by weighing raw material (daily dose) by following weight proportion
The soybean isoflavone of isoflavone content 35%, 0.15g
Shark cartilage micropowder 0.3g
Ground calcium carbonate 0.8g
Vitamin B 62mg
Folic acid 0.2mg
Micropowder silica gel 2mg
Magnesium stearate 1mg
Get ground calcium carbonate, add sodium carboxymethyl cellulose and make fine grained, add soybean isoflavone, shark cartilage micropowder, vitamin B 6, folic acid is evenly mixed, adds micropowder silica gel, magnesium stearate, and is evenly mixed.Measure the flowability of mixture, the uniformity of dosage units of mixture.Automatically loading capsule in the capsule machine.
Embodiment 2
Isoflavone content 43% soybean isoflavone, 0.5g
Shark cartilage micropowder 0.7g
Ground calcium carbonate 0.5g
Vitamin B 62mg
Folic acid 0.2mg
Micropowder silica gel 8mg
Magnesium stearate 5mg
Get ground calcium carbonate, add sodium carboxymethyl cellulose and make fine grained, add soybean isoflavone, shark cartilage micropowder, vitamin B 6, folic acid is evenly mixed, adds micropowder silica gel, magnesium stearate, and is evenly mixed.Measure the flowability of mixture, the uniformity of dosage units of mixture.Automatically loading capsule in the capsule machine.
Embodiment 3
Isoflavone content is 40% soybean isoflavone 0.25g
Shark cartilage micropowder 0.5g
Ground calcium carbonate 0.678g
Vitamin B 62mg
Folic acid 0.2mg
Micropowder silica gel 3mg
Magnesium stearate 3mg
Get ground calcium carbonate, add sodium carboxymethyl cellulose and make fine grained, add soybean isoflavone, shark cartilage micropowder, vitamin B 6, folic acid is evenly mixed, adds micropowder silica gel, magnesium stearate, and is evenly mixed.Measure the flowability of mixture, the uniformity of dosage units of mixture.Automatically loading capsule in the capsule machine.
Embodiment 4
Take by weighing raw material (daily dose) by following proportioning
Isoflavone content is 40% soybean isoflavone, 0.25g
Shark cartilage micropowder 0.5g
Ground calcium carbonate 0.339g
Precipitated calcium carbonate 0.339g
Vitamin B 62mg
Folic acid 0.2mg
Micropowder silica gel 2.5mg
Magnesium stearate 3mg
Take by weighing ground calcium carbonate and precipitated calcium carbonate, add sodium carboxymethyl cellulose and make fine grained, add soybean isoflavone, shark cartilage micropowder, vitamin B 6, folic acid is evenly mixed, adds micropowder silica gel, magnesium stearate, and is evenly mixed.Measure the flowability of mixture, the uniformity of dosage units of mixture.Automatically loading capsule in the capsule machine.

Claims (3)

1, the capsule preparations of a kind of bone density improving and deferring senility is characterized in that being made daily dose by the component of following weight proportion:
The soybean isoflavone of isoflavone content 35~43%, 0.15-0.5g
Shark cartilage micropowder 0.3-0.7g
Ground calcium carbonate 0.5-0.8g
Vitamin B 62mg
Folic acid 0.2mg
Micropowder silica gel 2-8mg
Magnesium stearate 1-5mg.
2, by the capsule preparations of described bone density improving of claim 1 and deferring senility, wherein the weight proportion of each component is:
Isoflavone content is 40% soybean isoflavone 0.25g
Shark cartilage micropowder 0.5g
Ground calcium carbonate 0.678g
Vitamin B 62mg
Folic acid 0.2mg
Micropowder silica gel 3mg
Magnesium stearate 3mg.
3, the preparation method of the capsule preparations of bone density improving according to claim 1 and 2 and deferring senility is characterized in that by following step:
Get ground calcium carbonate, add sodium carboxymethyl cellulose and make fine grained, add soybean isoflavone, shark cartilage micropowder, vitamin B 6, folic acid is evenly mixed, adds micropowder silica gel, magnesium stearate, and is evenly mixed, measures the flowability of mixture, and the uniformity of dosage units of mixture is being loaded capsule in the capsule machine automatically.
CNB200510029989XA 2005-09-23 2005-09-23 Bone density-increasing and senility-postponing capsule formulation Expired - Fee Related CN100496513C (en)

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Application Number Priority Date Filing Date Title
CNB200510029989XA CN100496513C (en) 2005-09-23 2005-09-23 Bone density-increasing and senility-postponing capsule formulation

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CN100496513C true CN100496513C (en) 2009-06-10

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1903220B (en) * 2006-07-12 2011-07-06 江中药业股份有限公司 Health-care food with function of improving skeletal density and its prepn. method
CN105192701A (en) * 2015-10-19 2015-12-30 宜都宏济科技有限公司 Sturgeon compound preparation and preparation process thereof
CN108478595B (en) * 2018-05-01 2021-07-02 海南施宝生物科技有限公司 A pharmaceutical composition containing calcium carbonate, vitamin D3, and vitamin K2

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