CN104042837A - Pharmaceutical composition for degenerative changes of bone and bone joints - Google Patents
Pharmaceutical composition for degenerative changes of bone and bone joints Download PDFInfo
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Abstract
The invention provides a pharmaceutical composition for degenerative changes of bone and bone joints. The pharmaceutical composition is prepared from D-glucosamine sulfate, red deer bone powder, medicinal cyathula root, rhizoma drynariae, salvia miltiorrhiza, wolfberry fruit, Chinese yam, radix puerariae, hawthorn and mint. According to the pathogenesis characteristics of diseases, the pharmaceutical composition has excellent treatment effects on both degenerative osteoarthropathy and osteoporosis according to the basic rule of treatment of treating both cause and symptoms and combining tonifying and dredging; and the pharmaceutical composition conforms to the clinical practice of general coexistence of the two diseases in middle-aged and elder patients and overcomes the defect of single efficacy of the existing products.
Description
Technical field
The invention belongs to the field of Chinese medicines, be specifically related to a kind of for preventing and treat pharmaceutical composition and the application thereof of bone and osteoarticular retrograde affection.
Background technology
Degenerative osteoarthritis and osteoporosis are clinical common two kinds of bones and osteoarthrosis degenerative disease, be mainly in middle-aged and elderly people, sickness rate increased with the age, bring very big burden to family and society, and along with Chinese society progresses into aging, the problem being caused by it is more and more outstanding.
Degenerative osteoarthritis (Osteoarthritis, OA) is a kind of degeneration taking articular cartilage, destruction and the hyperosteogeny chronic joint disease as feature, claims again osteoarthritis, degenerative osteoarthritis.It is apt to occur in some specific joint, gets involved the most common with waist, knee joint.Domestic research shows, more than 60 years old crowd sickness rate reaches 50%, and more than 70 years old in crowd, nearly 80% suffers from knee joint osteoarthritis.Osteoporosis (Osteoporosis, OP) be taking general bone amount reduce, the microstructure degeneration of bone increases and is easy to occur the general skeletal diseases of fracture as fragility feature, that cause bone.Epidemiological study prediction of result, at present there is sufferers of osteoporosis face (comprising that bone amount reduces) 8,400 ten thousand in China, accounts for 6.6% of total population, will reach 21,200 ten thousand to the year two thousand fifty, accounts for 13.2% of total population.Above-mentioned two kinds of diseases are degenerative disease, and sickness rate becomes positive correlation with increasing age, and clinically usually and deposit appearance.
At present, it is main to the west of the treatment for bone and osteoarthrosis degenerative disease, curing therapy.For example, degenerative osteoarthritis doctor trained in Western medicine generally adopts antalgic and inflammation relieving method to treat, and adopts operation method to treat to late period.But the chemicals of antalgic and inflammation relieving usually causes gastrointestinal side effect and increases bleeding tendency, operation needs compared with high cost and can bring misery to patient.Osteoporotic western medical treatment mainly comprises bone resorption inhibitor (such as estrogen replacement therapy, calcitonin, diphosphonate etc.), bone mineralizer, bone formation-promoter three major types.These medicines are mostly expensive, and have obvious side effect.It is reported, life-time service estrogen has the possibility of bringing out breast carcinoma; And due to the difference of patient's calcium absorption ability, the curative effect of calcitonin, vitamin D and calcium preparation is unsatisfactory.Therefore, increasing scholar turns to Chinese medicine to seek the medicine of determined curative effect, safe and reliable, treating both the principal and secondary aspects of a disease gradually.
Motherland's traditional medicine does not have " osteoarticular retrograde affection ", " osteoporosis " this class name of disease, but according to its etiology and pathogenesis and Clinical Manifestations, very similar, wherein especially more accurate on etiology and pathogenesis, clinical manifestation and qualitative location with " bone withers " to the card such as " bone is withered ", " bone withers " of Chinese medicine, " rheumatism involving the bone ", " osteomyelitis ".Chinese medicine is thought " the kidney generating marrow and dominating bone ".Constitutional degenerative osteoarthritis and osteoporosis are mainly because of renal failure and exhaustion of kidney-essence with promoting reproductive function causes physique and configuration of the body being very feeble and atrophied, flaccidity of the extremities.So, the Etiological oldly dirtyly decline, deficiency of kidney-essence being primary disease, it is the main pathogenesis of primary disease that deficiency of kidney essence, marrow subtract bone withered.Meanwhile, Chinese medicine have saying of " essence and blood sharing the same origin ", " The liver and the kidney have a common source ", and after climacteric, body constitution changes and adds the factors such as disorder of emotion and make the pathogenesis of deficiency of liver-blood, depression of liver-QI very common.Wherein, deficiency of liver-blood can cause neural loss, bone marrow is lost support, limbs need not; Depression of liver-QI can cause QI and blood retardance, bone marrow venation stasis, sclerotin and lose it and support and show as the pain weak disease of withering.Moreover Chinese medicine thinks that The spleen and stomach provide the material basis of the acquired, main transporting and transforming nutrients from foodstuff is precise and tiny is source of generating QI and blood, and main muscle extremity.As uncomfortable in diet, work and rest mistake degree, causes weakness of the spleen and stomach, loses the day after tomorrow and supports, and can cause essence of water and grain deficiency on the one hand, and muscle bone marrow loses supports, flaccidity of the limbs; Insufficiency of the spleenly on the other hand can not take a tonic or nourishing food to build up one's health congenitally, can cause again deficiency of kidney-essence, muscles and bones to lose supporting, bone withers the withered disease of bone.Therefore, Chinese medicine degenerative osteoarthritis and osteoporosis are usually started with from aspects such as invigorating the liver and kidney, bone and muscle strengthening, strengthening the spleen stomach, promoting blood circulation to remove obstruction in the collateral.
Present stage, more existing Chinese medicines were used for the treatment of bone and osteoarthrosis degenerative disease, these Chinese medicines have determined curative effect, toxic and side effects little, can long-term prescription etc. advantage, but there is the defects such as kind is few, curative effect is single.The medicine of what therefore, Application and Development was new be used for the treatment of bone and osteoarthrosis degenerative disease has important economy and social value.
Summary of the invention
The object of the present invention is to provide a kind of for preventing and treat the pharmaceutical composition of bone and osteoarticular retrograde affection, especially for prevention and treatment degenerative osteoarthritis and osteoporotic pharmaceutical composition.According to the etiology and pathogenesis feature of disease, the present invention is led to and is combined into the basic rule for the treatment of with treating both the principal and the secondary aspects of a disease at the same time, benefit, and selecting D-glucosamine sulfate, Cervus elaphus linnaeus bone meal, Radix Cyathulae, Rhizoma Drynariae, Radix Salviae Miltiorrhizae, Fructus Lycii, Rhizoma Dioscoreae, Radix Puerariae, Fructus Crataegi, Herba Menthae is crude drug.
Concrete scheme of the present invention is as follows:
A kind of for preventing and treat the pharmaceutical composition of bone and osteoarticular retrograde affection, by weight percentage, formulated by following crude drug: D-glucosamine sulfate 25～35%, Cervus elaphus linnaeus bone meal 15～20%, Radix Cyathulae 8～11%, Rhizoma Drynariae 6～10%, Radix Salviae Miltiorrhizae 5～9%, Fructus Lycii 5～9%, Rhizoma Dioscoreae 5～9%, Radix Puerariae 5～9%, Fructus Crataegi 4～8%, Herba Menthae 5～9%.
Preferably, above-mentioned for preventing and treat the pharmaceutical composition of bone and osteoarticular retrograde affection, the proportioning of each crude drug is: D-glucosamine sulfate 28～32%, Cervus elaphus linnaeus bone meal 16～18%, Radix Cyathulae 9～10%, Rhizoma Drynariae 7～9%, Radix Salviae Miltiorrhizae 6～7%, Fructus Lycii 6～7%, Rhizoma Dioscoreae 6～7%, Radix Puerariae 6～7%, Fructus Crataegi 4～6%, Herba Menthae 5～6%.
Further preferably, above-mentioned for preventing and treat the pharmaceutical composition of bone and osteoarticular retrograde affection, the proportioning of each crude drug is: D-glucosamine sulfate 30%, Cervus elaphus linnaeus bone meal 17.5%, Radix Cyathulae 10%, Rhizoma Drynariae 7.5%, Radix Salviae Miltiorrhizae 6.25%, Fructus Lycii 6.25%, Rhizoma Dioscoreae 6.25%, Radix Puerariae 6.25%, Fructus Crataegi 5%, Herba Menthae 5%.
Aforementioned pharmaceutical compositions is for prevention and treatment bone and osteoarticular retrograde affection, particularly degenerative osteoarthritis and/or osteoporosis.
Cervus elaphus Linnaeas bone, Rhizoma Drynariae, Radix Cyathulae, Fructus Lycii, Rhizoma Dioscoreae the kidney invigorating unit, nourishing the liver blood, strengthening the spleen gas in side, to cure the disease originally; The mark that wherein Cervus elaphus Linnaeas bone, Rhizoma Drynariae, Radix Cyathulae can also doublely be cured the disease.Cervus elaphus Linnaeas bone, sweet in the mouth, property slight fever, function tonify deficiency is thin, treat cold numbness, bone and muscle strengthening, can treat insufficiency of kidney-YANG, the cold numbness of muscles and bones, bone and wither meat but.Radix Cyathulae, bitter in the mouth, acid, property is flat, returns liver, kidney channel, function promoting blood circulation to restore menstrual flow, conducting blood to flow downwards, invigorating the liver and kidney, bone and muscle strengthening, relieving stranguria by diuresis.Rhizoma Drynariae, bitter in the mouth, warm in nature, enter liver, kidney channel, function the kidney invigorating bone strengthening, promoting blood circulation and hemostasis, continuously hinder pain relieving.Dai Yuanli " key to Diagnosis and Treatment " call it " with the deficiency and coldness of kidney, this medicine the kidney warming, can rise bone wither should ", not only can assist the bone of the Cervus elaphus Linnaeas bone treatment insufficiency of kidney-YANG meat that withers but to effect a permanent cure, also can promoting blood circulation to remove obstruction in the collateral and the mark of curing the disease.Fructus Lycii, sweet in the mouth matter profit and property is flat, function nourishing the liver and kidney, beneficial intensive culture blood, be longer than marrow dry bones due to treatment kidney essense deficiency of liver-blood and wither." property of medicine opinion " claims its " all insufficiency of essence of energy tonification, remove wind, tonification muscles and bones "." Treatise on Dietetic Therapy " also says its energy " hard muscle is resistance to old, and except wind, tonification muscles and bones, the beneficial people of energy, removes asthenia ".Cervus elaphus Linnaeas bone and Fructus Lycii, one treats first YANG deficiency of kidney and cold numbness bone withers, and one treats that the cloudy essence of kidney is not filled and marrow dry bones withers, and the two cooperatively interacts, and the core pathogenesis that bone withers of suffering from a deficiency of the kidney jointly hits.Rhizoma Dioscoreae, sweet in the mouth, property is flat, returns spleen, lung, kidney channel, function supplementing QI and nourishing YIN, spleen reinforcing lung kidney." book on Chinese herbal medicine just " cloud: " Rhizoma Dioscoreae energy spleen invigorating tonify deficiency, grows essence and reinforce the kidney, and controls weakness, treats five kinds of strain and seven kinds of impairment." Rhizoma Dioscoreae has invigorating the spleen and replenishing QI and replenishing vital QI with drugs of warm nature muscle, supplementing the kidney to control the nocturnal and treat the double effects of lumbago due to renal deficiency, is the product that must use of the disease withered for the treatment of bone.
Medicine of the present invention is compatibility with Danshen, Radix Puerariae, Fructus Crataegi, mint blood stasis, eliminating impediment resistance, reduce phlegm turbid, hot and suffocating clearly, the network of promoting blood circulation simultaneously, auxiliary taking stopgap measures.Radix Salviae Miltiorrhizae, bitter in the mouth and cold nature, can activating blood circulation and unblocking obstruction.Radix Puerariae, acrid-sweet flavor, cool in nature, return taste warp, can disperse all numbness.Fructus Crataegi, sour in the mouth is sweet, and slightly warm in nature is returned spleen, stomach, Liver Channel, can promoting digestion and removing stagnation, circulation of qi promoting dissipating blood stasis.Herba Menthae, acrid in the mouth, cool in nature, return lung Liver Channel.It " removes anger gas, toxophoric antiperspirant, removing blood stasis dysentery relieving, easing joint movement " " property of medicine opinion " cloud." Records of Tradition Chinese and Western Medicine in Combination " cloud: " gas is clear for Herba Menthae, acrid in the mouth, and perfume (or spice) is altered, and property is flat.Saturating muscles and bones in its power energy, reaches flesh table outward, and the logical internal organs of a surname, run through meridians." therefore lose the pathogenesis of supporting for QI and blood retardance, bone marrow venation due to the liver losing its smoothly moving state, depression of liver-QI, the most suitable with Herba Menthae.
On the basis of above-mentioned tcm treatment according to syndrome differentiation, the further compatibility D-glucosamine of the present invention sulfate, with directly for bone, osteocyte and cartilaginous tissue, promote the proliferation and differentiation of osteocyte, promote the regeneration of chondrocyte, impaired joint is repaired, functional rehabilitation is normal.
Pharmaceutical composition of the present invention can be prepared from method well-known in the art by above-mentioned raw materials medicine.For example, instruct according to theory of Chinese medical science and modern crafts, Fructus Lycii, Rhizoma Drynariae, Radix Cyathulae, Radix Salviae Miltiorrhizae, Fructus Crataegi, aqua methnae are decocted or alcohol extraction active substance, Cervus elaphus linnaeus bone meal, Rhizoma Dioscoreae, Radix Puerariae are pulverized as end, add D-glucosamine sulfate, 80 orders sieve just mixed, and homogenizing mixes, and then carry out as required later stage packaging and process.
The applicable dosage form of pharmaceutical composition of the present invention can be all kinds of regular dosage forms such as tablet, capsule, granule, oral liquid.
The present invention also aims to provide the application of aforementioned pharmaceutical compositions in medicine or health product for the preparation of prevention and treatment bone and osteoarticular retrograde affection.
Compare with existing product, pharmaceutical composition of the present invention has the following advantages:
1. pharmaceutical composition of the present invention all has good therapeutical effect to degenerative osteoarthritis and osteoporosis, meet these two kinds of diseases in middle-older patient usually and the clinical practice of depositing, overcome the single defect of existing product effect.
2. pharmaceutical composition compatibility of the present invention uses marine organisms class raw material D-glucosamine sulfate and Chinese medicine material, has both met motherland's traditional medical theory, merges again modern medical outcome, treating both the principal and secondary aspects of a disease, Synergistic.Inventor is routine by the above-mentioned disease more than ten thousand of medicine composite for curing of the present invention in daily clinical practice, determined curative effect, and do not find obvious adverse reaction, effect is very remarkable.
Detailed description of the invention
Below by specific embodiment so that the invention will be further described, but should not be understood as limiting the scope of the invention.
test compositions
Shown according to the form below, formula takes raw material.First, respectively Fructus Lycii, Rhizoma Drynariae, Radix Cyathulae, Radix Salviae Miltiorrhizae, Fructus Crataegi, BOHE TONG are crossed to water boiling and extraction active substance, also dry, Cervus elaphus linnaeus bone meal, Rhizoma Dioscoreae, Radix Puerariae are pulverized as end; Then, previous materials is mixed, then it is just mixed to add D-glucosamine sulfate, 80 orders to sieve, homogenizing mixes; Finally, product is become to capsule with the metric system of 0.42g/ grain.
the test of various dose group
Respectively in 5 times, 10 times of standard body weight (taking 60kg) adult recommended dose and 30 times as low dosage, middle dosage and high dose, people Mus carries out experimentation after converting.
Below by clinical practice and laboratory research to confirm the function/effect of pharmaceutical composition of the present invention.
Test the experimentation of a sample increase bone substance density improving function
1. materials and methods
1.1 samples: be subject to test product capsule, content is yellowish-brown.
1.2 laboratory animals and feeding environment
Clean level Wistar rat, male 50, body weight 60.4g～74.7g, production licence number: SCXK-(Ji) 2007-0003, the clean level animal being provided by preclinical medicine institute of Jilin University Experimental Animal Center.
The clean laboratory animal environmental facility quality certification number, lucky moving establish word 10-1005, laboratory animal occupancy permit number: SYXK-(Ji) 2007-0009; 20 DEG C～22 DEG C of temperature, humidity 55%～65%; Normal feedstuff is provided by the prebiotic laboratory animal feed factory in Lvyuan District, Changchun, production licence number SCXK-(Ji) 2008-0002.
1.3 dosage are selected
According to 60kg Normal-weight adult meter, take in this product (capsule) 2 times every day, each 3,0.42g/ grain, i.e. 2.52g/60kg BW, wherein calcium content is 3.2%.Basic, normal, high three dosage groups as above are established in this experiment, i.e. 0.21g/kg BW, 0.42g/kg BW, 1.26g/kg BW is equivalent to 5,10,30 times of human body recommended dose; Separately establish low calcium matched group (normal feedstuff group, calcium content 1.5g/kg) and calcium carbonate control group (identical with high dose calcium level).
Respectively the tested material of three dosage is dissolved in to distilled water and mixes standardize solution to 100ml volumetric flask, adopt per os gavage mode to give tested material.Low calcium matched group give normal feedstuff simultaneously every day to distilled water gavage; Calcium carbonate control group is that the calcium carbonate 1.0g of calcium content 40% is dissolved in distilled water and makes suspension per os gavage mode to 100ml and give.Each group gavage volume is 1.0ml/100g BW.
1.4 feed formula
By this normal feedstuff preparation calcium carbonate control group and each dosage group.
Table 1 normal feedstuff formula (Ca
2+meter, is adjusted into 150mg/100g feedstuff)
Note: 1. need HIGH PRESSURE TREATMENT;
2. salt-mixture: each constituent content: KH in every kg salt-mixture
2pO
4, 501.4g; MgCO
3, 50.2g; Ferrous lactate, 5.4g; Zinc lactate, 4.16g; MnSO
45H
2o, 0.605g; Na
2seO
3, 6.6mg; KI, 7.76mg; CrCl6H
2o, 0.292g; With sucrose to 1kg.
3. mixed vitamin: each constituent content in every kg mixed vitamin: vitamin A: 400000IU; Vitamin D3: 100000IU; Vitamin E: 500IU; Vitamin K: 5mg; Vitamin B1: 600mg; Vitamin B2: 600mg; Vitamin B6: 700mg; Vitamin B12: 1mg; Nicotinic acid: 3g; Folic acid: 200mg; Calcium pantothenate: 1.6g; Biotin: 20mg; With sucrose to 1kg.
2. experimental technique
2.1 birth 4 weeks ablactation rats are through adapting to raising after one week, and fasting is weighed for 12 hours, by body weight random packet, and 10 every group, sub-cage rearing.Drink deionized water to avoid obtaining calcium from drinking-water.Each group according to dosage design gives sample 3 months.Record weekly each treated animal body weight.
2.2 calcium metabolism tests: do calcium absorption test on the 3rd week, then continue to feed.Calcium absorption experiment: the ablactation rat sub-cage rearing surrounding of birth surrounding.Survey body weight weekly, body is long.Test and after three weeks, carry out calcium metabolism test in three days.Record three days food-intakes, collect 72 hours feces, measure calcium content in feedstuff and feces.Feed Sample evenly mixes and crosses 20 mesh sieves; 105 DEG C of oven for drying of rat fecal specimens, to cooling rear levigate in exsiccator.Note preventing from polluting.Accurately take and dry levigate a certain amount of sample, be placed in 150ml triangular flask, the little funnel of upper cover, adds mixed acid (nitric acid: perchloric acid=4:1) 15ml, and on electric hot plate, hot digestion is to emitting white cigarette clear, colorless.Addend ml deionized water after Digestive system clear, colorless, boils to catch up with except remaining acid, repeats twice, and the volume of last Digestive system is no more than 1ml.When sample digestion, should do blank assay, same volume mixed acid while adding with treatments of the sample, under the same conditions digestion simultaneously.Carry out according to atomic absorption spectrophotometer instrument description step, measure liquid, standard solution and blank and all use 0.5% lanthana solution dilution, standardize solution.Calculate by following formula:
Apparent absorption rate %=(taking in calcium-excrement calcium)/absorption calcium × 100% of calcium
2.3 femoral bmds are measured: dissect rat, peel off left side femur, France of application Sino-Japanese Party Hospital, Jilin Univ. produces dual energy X-ray absorptiometry instrument, and model LEXXODEXA type borne densitometers is measured rat femur mid point and femur distal end bone density.Femur is dried to constant weight, weigh key heavy.
2.4 calcium content of bone are measured: adopt atomic absorption method, atomic absorption instrument AA6401F type.Get rat one side femur dries to constant weight in 105 DEG C of baking ovens.Accurately take a certain amount of sample, be placed in 150ml triangular flask, the little funnel of upper cover, adds mixed acid (nitric acid: perchloric acid=4:1) 15ml, and on electric hot plate, hot digestion is to emitting white cigarette clear, colorless.Addend ml deionized water after Digestive system clear, colorless, boils to catch up with except remaining acid, repeats twice, and the volume of last Digestive system is no more than 1ml.When sample digestion, should do blank assay, same volume mixed acid while adding with treatments of the sample, under the same conditions digestion simultaneously.Carry out according to atomic absorption spectrophotometer instrument description step, measure liquid, standard solution and blank and all use 0.5% lanthana solution dilution, standardize solution.Calculate by following formula:
Calcium (mg/g)=(C × V × f)/(m × 1000)
Note: C represents to measure concentration of element in test liquid (ug/ml); V represents constant volume, V=25ml; F represents extension rate, f=250; M represents sampling amount (g)
3. statistical method
Date processing adopts one factor analysis of variance in SPSS11.5 to carry out average comparison, and variance is neat, relatively uses between two LDS method between each group; Heterogeneity of variance, relatively adopts Tamhane method between two between each group.
4. experimental result
4.1 impacts on rat body weight
The impact of table 1 tested material on rat body weight
P1: each experimental group and the comparison of normal feedstuff group; P2: each experimental group and the comparison of calcium matched group.
*: with normal feedstuff group or relatively P<0.05 of calcium matched group; #: with normal feedstuff group or relatively P<0.01 of calcium matched group.
From table 1, relatively rat starting weight there was no significant difference (P>0.05) of each experimental group and calcium matched group, normal feedstuff group.Give tested medicine after 3 months, high dose group weighs eventually and increases weight higher than normal feedstuff group, has significant difference (P<0.05); Other each groups and relatively there was no significant difference (P>0.05) of normal feedstuff group, calcium matched group.
4.2 impacts on rat height
Table 2 tested material affects rat height
P1: each experimental group and the comparison of normal feedstuff group; P2: each experimental group and the comparison of calcium matched group.
From table 2, each experimental group compares there was no significant difference (P>0.05) with normal feedstuff group, calcium matched group respectively.
4.3 pairs of calcium in rats metabolic effect
Table 3 is tested calcium in rats metabolic effect
P: each experimental group and the comparison of calcium matched group; *: with normal feedstuff group or relatively P<0.05 of calcium matched group; #: with normal feedstuff group or relatively P<0.01 of calcium matched group;
From table 3, administration is after 3 months, and high dose group apparent absorption rate and calcium matched group are relatively without significance poor (P>0.05); In, low dose group apparent absorption rate is apparently higher than matched group, has significant difference (P<0.05).Illustrate that this tested material apparent absorption rate is not less than calcium matched group, can be used as calcium complement agent.
4.4 on rat femur weight, bone calcium and femoral bmd impact
Table 4 is on rat femur weight, bone calcium and femoral bmd impact
P1: each experimental group and the comparison of normal feedstuff group; The each experimental group of P2 and the comparison of calcium matched group.
#: with normal feedstuff group or relatively P<0.01 of calcium matched group;
From table 4, high dose group femur dry weight, femur distal end density and femur center bone density are apparently higher than normal feedstuff group, its difference has significance (P<0.05), compares without significant (P>0.05) with calcium matched group; Each dosage group thigh calcium content compares without significant (P>0.05) with normal feedstuff group, calcium matched group respectively.Illustrate that this tested material is significantly higher than normal feedstuff and is not less than calcium carbonate control group femur distal end bone density and mid point bone density.
From above-mentioned experimental result, tested material has increase bone substance density improving function.
Test two tested material toxicity tests
1. test item:
Its mouse oral acute toxicity test
Micronucleus test
Mouse sperm deformity test
Salmonella reversion test
30d feeding trial
2. test basis
" health food inspection and assessment technique specification " 2003 editions health food Toxicological evaluation programs and method of inspection specifications: the Part II toxicology method of inspection one, acute toxicity test two, Salmonella reversion test three, bone marrow cell micronucleus test five, mouse sperm deformity test 12,30d feeding trial.
3. experimental procedure
Carry out according to above-mentioned assessment process and method of inspection specification.
4. result and judgement
Its mouse oral acute toxicity test LD50>21.5g/kg BW of this tested medicine, according to acute toxicity median lethal dose(LD 50), classification belongs to nontoxic level.Micronuclei in mice, mouse sperm deformity are tested, Salmonella reversion test is all negative.30d feeding trial is showed no harmful effect to indices such as routine blood test, blood biochemistry checking, organ coefficient and body weight, weightening finish, food-intake, food utilizations.Histopathology is observed, and liver,spleen,kidney, Stomach duodenum, testis, ovary are showed no significant pathological change.
Testing three tested medicine physics and chemistry parts detects
1. functional component test
Detect according to " health food inspection and assessment technique specification " (version in 2003) relevant regulations effective ingredient of three batches to tested medicine, result is as follows:
2. stability test
According to " health food inspection and assessment technique specification " (version in 2003) GB/T20365-2006, Pharmacopoeia of the People's Republic of China annex XIIA-2005GB/T5009.3.4.11.12.17.19-2003, the stability of three batch of GB/T5009.19-2008 relevant regulations to tested medicine detects, and result is as follows:
3. hygiene inspection
According to Q/CHH2003-2009, JJF1070-2005 Pharmacopoeia of the People's Republic of China annex XIIA-2005GB/T5009.3.4.11.12.17.19-2003, GB/T5009.19-2008, " health food inspection and assessment technique specification " (version in 2003) GB/T20365-2006 relevant regulations Hygienic Index of three batches to tested medicine detect, and result is as follows:
Testing four tested material microorganism parts detects
1. stability test
Detect according to " health food inspection and assessment technique specification " (version in 2003), Pharmacopoeia of the People's Republic of China annex XIIA-2005GB/T4789.2.3.4.10-2008, the microbiology stability of three batches of GB/T4789.5.11.15-2003 relevant regulations to tested medicine, result is as follows:
2. hygiene inspection
Detect according to " health food inspection and assessment technique specification " (version in 2003), Pharmacopoeia of the People's Republic of China annex XIIA-2005GB/T4789.2.4.10-2008, the microbiology stability of three batches of GB/T4789.5.11.15-2003 relevant regulations to tested medicine, result is as follows:
Test five clinical researches
1. case sample
In the 2010-2011 of Jilin Renmin Hospital consulting patients in out-patient department, select continuously medical sample 160 examples, all cases meet the knee joint degenerative osteoarthritis diagnostic criteria of Americanism damp disease association's nineteen ninety-five, and get rid of osteoarthritis and knee joint rheumatic arthritis due to knee tumor, tuberculosis and knee joint suppurative inflammation, congenital malformation meniscus injury, knee intra-articular fracture, rheumatoid arthritis etc.
Above-mentioned case is divided into 2 groups at random, every group of 80 examples.For ensureing the comparability of two groups, grouping meets following requirement: two groups of Gender ages and disease time there was no significant difference (P>0.05); Two groups of patients upper downstairs (slope) bitterly, has squatted bitterly, joint bends and stretches the symptom and signs such as situation and knee joint x-ray check result and knee joint function standards of grading (HSS) and is showed no significant difference (P>0.05).
2. administration and evaluation criterion
Administration group gives this pharmaceutical composition of the present invention, and matched group gives XIANLING GUBAO JIAONANG.Treat 3 courses for the treatment of continuously, 10d is a course for the treatment of.During two groups of patient treatments, all to rest as main, reduce knee joint as far as possible and bear a heavy burden, meanwhile, stop using other Chinese and western drugses and the treatment relevant to treatment primary disease.Two groups of patients all evaluate after the 3rd course for the treatment of.
The standard of curative effect evaluation:
According to standard by knee joint by 30 points of pain, 22 points of functions, 18 points of mobilities, 10 points of muscular strengths, deformity 10 points, 10 points of stability, amount to 100 points.And set clinical efficacy grade, and excellent >85 divides, and good 70～84 points, general 60～69 points, poor <60 divides.All patients mark according to HSS scoring format.
3. result
Therapeutic outcome show, through the treatment of 3 courses for the treatment of, excellent 30 examples for the treatment of group, good 35 examples, in 7 examples, differ from 8 examples; Excellent 10 examples of matched group, good 21 examples, in 31 examples, differ from 18 examples, two groups of effective percentage are respectively 90.0% and 77.5%, have significant difference.
After treatment, administration group HHS marks apparently higher than matched group, and two groups relatively have significant difference (P<0.01), illustrate that this drug regimen is to knee joint degenerative osteoarthritis improvement effect highly significant.
Claims (5)
1. one kind for preventing and treat the pharmaceutical composition of bone and osteoarticular retrograde affection, by weight percentage, formulated by following crude drug: D-glucosamine sulfate 25～35%, Cervus elaphus linnaeus bone meal 15～20%, Radix Cyathulae 8～11%, Rhizoma Drynariae 6～10%, Radix Salviae Miltiorrhizae 5～9%, Fructus Lycii 5～9%, Rhizoma Dioscoreae 5～9%, Radix Puerariae 5～9%, Fructus Crataegi 4～8%, Herba Menthae 5～9%.
2. according to claim 1 for preventing and treat the pharmaceutical composition of bone and osteoarticular retrograde affection, it is characterized in that, the proportioning of each crude drug is: D-glucosamine sulfate 28～32%, Cervus elaphus linnaeus bone meal 16～18%, Radix Cyathulae 9～10%, Rhizoma Drynariae 7～9%, Radix Salviae Miltiorrhizae 6～7%, Fructus Lycii 6～7%, Rhizoma Dioscoreae 6～7%, Radix Puerariae 6～7%, Fructus Crataegi 4～6%, Herba Menthae 5～6%.
3. according to claim 1 for preventing and treat the pharmaceutical composition of bone and osteoarticular retrograde affection, it is characterized in that, the proportioning of each crude drug is: D-glucosamine sulfate 30%, Cervus elaphus linnaeus bone meal 17.5%, Radix Cyathulae 10%, Rhizoma Drynariae 7.5%, Radix Salviae Miltiorrhizae 6.25%, Fructus Lycii 6.25%, Rhizoma Dioscoreae 6.25%, Radix Puerariae 6.25%, Fructus Crataegi 5%, Herba Menthae 5%.
According to described in any one in claim 1-3 for preventing and treat the pharmaceutical composition of bone and osteoarticular retrograde affection, it is characterized in that: described bone and osteoarticular retrograde affection refer to degenerative osteoarthritis and/or osteoporosis.
In claim 1-4 described in any one for the pharmaceutical composition that prevents and treat bone and osteoarticular retrograde affection for the preparation of prevention and treatment bone and the medicine of osteoarticular retrograde affection or the application of health product.
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