CN101590109B - Compound preparation for treating back pain caused by senile osteoporosis and preparation method thereof - Google Patents
Compound preparation for treating back pain caused by senile osteoporosis and preparation method thereof Download PDFInfo
- Publication number
- CN101590109B CN101590109B CN 200910004167 CN200910004167A CN101590109B CN 101590109 B CN101590109 B CN 101590109B CN 200910004167 CN200910004167 CN 200910004167 CN 200910004167 A CN200910004167 A CN 200910004167A CN 101590109 B CN101590109 B CN 101590109B
- Authority
- CN
- China
- Prior art keywords
- back pain
- pain caused
- preparation
- senile osteoporosis
- compound preparation
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
Landscapes
- Medicines Containing Plant Substances (AREA)
Abstract
The invention belongs to the field of Chinese medicaments and relates to a Chinese medicinal preparation for treating back pain caused by senile osteoporosis and a preparation method thereof. The preparation is prepared by mixing medicinal materials including raidx astragali, epimedium herb, yerbadetajo herb, salvia miltiorrhiza bunge, radix achyranthis bidentatae and water extract of orientavine with accessories, granulating the mixture and tabletting the mixture. The medicinal materials are soaked in water and decocted respectively. The decoctions are mixed, concentrated till the density is about 1.05 and added with ethanol till the concentration is 60 percent; the mixed decoction is placed over one night for deposition in the ethanol; the ethanol is recovered from filtrate and the filtrate is concentrated, dried at reduced pressure and crushed to form extract powder; and the extract powder is added with the accessories, and the mixture are uniformly mixed, granulated, tableted and coated with a film to form the Chinese medicinal preparation. Applying a therapeutic principle of supplementing qi, tonifying kidney, dispersing blood stasis and dredging collateral, the Chinese medicinal preparation representing an academic thinking of addressing both the symptoms and root causes and prevention before disease onset can improve lumbar vertebra local blood microcirculation, inhibit inflammatory mediator, delay osteoporosis, repair lumbar nerve injuries and prevent and cure the back pain caused by the senile osteoporosis.
Description
Technical field
The invention belongs to the field of Chinese medicines, be specifically related to a kind of compound preparation and method for preparing of treating back pain caused by senile osteoporosis.
Background technology
Lumbago and skelalgia is the most common pain syndromes of people, brings inconvenience for production, work, studying and living.Along with the raising of social life level, the average life span prolongs, and the back pain caused by senile osteoporosis number of the infected constantly increases.Back pain caused by senile osteoporosis is the modal waist illness of elderly population more than 50 years old, and the sickness rate in elderly population is about 25.2%.After its morbidity mainly is the vertebral body osteoporosis; Cause vertebral body bone trabecula fracture, lumbar intervertebral disc degenerative change, lumbar spinal stenosis, compression fracture of vertabral body etc.; Make adjacent nerve root, spinal cord etc. oppressed by chemical irritation or physical property, thereby produce lumbago, a side or symptoms such as bilateral lower limb pain, numbness.
Back pain caused by senile osteoporosis is seen with persistence waist dull pain more, occurs lumbago mostly earlier, occurs skelalgia afterwards again.Wherein,,, cause cauda equina nerve or radicular symptom, weakness of the lower extremities occurs owing to the increase of intraspinal pressure power, cauda equina nerve ischemia, root compression with lumbar intervertebral disc degenerative change, lumbar spinal stenosis changer, the severe patient drop foot, walking is dragging step; With vertebral body bone trabecula fracture, compression fracture of vertabral body person, often touching difficulty more causes long-term chronic back pain; The performance that cauda equina nerves such as gatism are impaired perineal position numbness, twinge can appear, in the back pain caused by senile osteoporosis patient that some are serious; Breast, compression fracture of lumbar vertebra cause vertebra palintrope, chest deformity, and vital capacity and maximal breathing capacity are significantly reduced, and the emphysema incidence rate can be up to 40%, occur uncomfortable in chest, breathe hard, symptom such as dyspnea.
Estimate that according to the foundation of American National osteoporosis the U.S. has 0.7 hundred million people to suffer from lumbago the whole year, the vertebral fracture property lumbago that annual newly-increased 700,000 osteoporosis cause, wherein 260,000 because pain is accepted non-operative treatment, 150,000 person-times of hospitalization.The expense that the patient pays for treatment and the loss that is caused of can not working are worth about 7,000,000,000 dollars.The study on large sample of the relevant elderly woman in Europe shows: the sickness rate of compression fracture of vertabral body increases with the increase at age, and 50-54 year is 11.5%; 55-59 year is 14.6%; 60-64 is 16.8%; 65-69 year is 23.5%; 70-74 year is 27.2%; 75-79 year is 34.8%.Saying of " five mouthfuls other, people's lumbago " then arranged in China.Along with aged tendency of population, the expense that is used to treat back pain caused by senile osteoporosis constantly rises.Therefore, stable, the determined curative effect of development quality, safety new Chinese medicine inexpensive, taking convenience have good economic and social benefit.
Summary of the invention
The object of the invention is to provide the compound Chinese medicinal preparation of a kind of determined curative effect, safe treatment back pain caused by senile osteoporosis.
The traditional Chinese medical science thinks that the cause of disease of back pain caused by senile osteoporosis mainly is " qi-deficiency kidney-deficiency, the resistance of blood stasis network ".The present invention is with " vital energy benefiting and the kidney invigorating; the disperse blood stasis and dredge collateral " rule for the treatment back pain caused by senile osteoporosis; Follow " giving consideration to both the incidental and fundamental ", " prevention of diseae's " academic thought; Adopt the following raw material medicaments component to process compound preparation, through improving prevention and treatment back pain caused by senile osteoporosis such as lumbar vertebra local microcirculation, inflammation-inhibiting medium, delaying osteoporosis, the damage of reparation lumbar nerves.
Compound preparation of the present invention is processed by effective ingredient and pharmaceutical carrier, it is characterized in that said effective ingredient is made up of the crude drug component of following weight proportion scope: the Radix Astragali 450～250g, Herba Epimedii 350～150g, Herba Ecliptae 350～150g, Radix Salviae Miltiorrhizae 300～100g, Radix Achyranthis Bidentatae 300～100g, Caulis Sinomenii 300～100g (crude drug dosage).
The preferred weight ratio range of described crude drug is: the Radix Astragali 400～300g, Herba Epimedii 300～200g, Herba Ecliptae 300～200g, Radix Salviae Miltiorrhizae 250～150g, Radix Achyranthis Bidentatae 250～150g, Caulis Sinomenii 250～150g (crude drug dosage).
The more preferably weight proportion of described crude drug is: the Radix Astragali 350～250g, Herba Epimedii 250～150g, Herba Ecliptae 250～150g, Radix Salviae Miltiorrhizae 200～100g, Radix Achyranthis Bidentatae 200～100g, Caulis Sinomenii 200～100g (crude drug dosage).
Compound preparation of the present invention can be processed various oral formulations by conventional method, comprises tablet, granule, capsule, mixture, powder etc.
Further purpose of the present invention provides the method for preparing of above-mentioned compound preparation.
Compound preparation of the present invention prepares through following method and step:
1. take by weighing each medical material by prescription weight, soak 1h, decoct each 0.5～1.5h 1～3 time; One fries in shallow oil and adds 10～14 times in water, and two, three fry in shallow oil and add 6～10 times in water, merge decoction liquor; Filter, under 60～70 ℃ of temperature, it is 1.05～1.30 extractum that filtrating is concentrated into relative density.Wherein, preferably decoct 2 times, decoct 1h at every turn, one fries in shallow oil and adds 14 times in water, and two fry in shallow oil 10 times of amount of water, merges decoction liquor, filters, and it is 1.05～1.07 extractum liquid that preferred filtrating is concentrated into relative density;
2. add ethanol in the above-mentioned 1. extractum liquid, to concentration of alcohol be 50%～80%, preferably adding ethanol to concentration is 60%; Hold over night, precipitate with ethanol filters, and filtrating is at 60～70 ℃ of temperature recover ethanol, and to be concentrated into relative density be 1.35～1.40 equivalent extract;
3. above-mentioned 2. equivalent extract is drying under reduced pressure in the time of 70～80 ℃, is ground into fine powder, crosses 60 mesh sieves, gets the extract powder of drug component of the present invention;
4. according to extract powder: filler: disintegrating agent=12: 5: 1 weight proportion (extract powder 300g, microcrystalline Cellulose 101 is 125g, cross-linked carboxymethyl cellulose is received 25g); Get the above-mentioned component that 3. makes; The filler, the disintegrating agent that add the appeal ratio, mixing adopts dry granulation; Be pressed into 1000, the heavy 0.45g of sheet.The bag film-coat is processed finished tablet, promptly gets.
The method for preparing of medicine activity component of the present invention; Adopt water extraction method and preferred extracted chemical compound, the phenolic acid compound in the Radix Salviae Miltiorrhizae and the danshensu of Saponin class in the Radix Astragali, the Herba Epimedii and the main effective ingredient in other component after decocting number of times, time and amount of water; The density and the concentration of alcohol of preferred then precipitate with ethanol carry out the precipitate with ethanol purification; Effective component extracting and remove impurity to greatest extent; Down concentrated, dry at the decompression cryogenic conditions, simultaneously adjuvant, method of granulating and the condition etc. of drying means and condition, preparations shaping technology have been carried out examination, screening, optimize the preparation technology who is suitable for suitability for industrialized production.
The interim decoction before compound preparation of the present invention can avoid Chinese medicine decoction to take; Put for a long time and be prone to enzyme and lose rotten and bring a lot of inconveniences to the patient; According to the clinical application characteristics, preserve the physicochemical property of main flavour of a drug in the prescription and combine modern preparation technique; Process solid preparations such as granule, tablet, capsule, powder, the demand that has satisfied the patient easily and effectively.
The present invention has carried out zoopery, and the result shows:
Mice hot plate experiment, compound preparation 2 multiple dose groups of the present invention, etc. multiple dose group, 0.5 multiple dose group, 0.25 multiple dose group pain threshold all be higher than matched group at 60min and 120min, significant difference is arranged;
Mice ear experiment, compound preparation 2 multiple dose groups of the present invention, etc. multiple dose group, 0.5 multiple dose group inhibitory rate of intumesce all be lower than matched group, significant difference is arranged;
Cytologic experiment, mtt assay testing result show that compound preparation of the present invention can obviously promote osteoblastic propagation, compare with matched group, and significant differences (P＜0.01) is arranged;
The real-time fluorescence quantitative PCR reaction result shows; Compare with matched group; Compound preparation of the present invention can promote the expression (P＜0.01) of osteoblast BMP-2 mRNA, promotes the expression of osteoblast Type I Collagen mRNA, promotes osteoblast BGP mRNA to express (P＜0.01).
The result confirms; Compound preparation of the present invention not only can be removed back pain caused by senile osteoporosis clinical symptoms sign; And can be through improving aspect prevention back pain caused by senile osteoporosis such as lumbar vertebra local microcirculation, inflammation-inhibiting medium, delaying osteoporosis, the damage of reparation lumbar nerves; The after treatment effect reduces recurrence, embodied " giving consideration to both the incidental and fundamental ", " prevention of diseae's " academic thought.
The specific embodiment
Embodiment 1
Raw material prescription: Radix Astragali 450g, Herba Epimedii 350g, Herba Ecliptae 350g, Radix Salviae Miltiorrhizae 300g, Radix Achyranthis Bidentatae 300g, Caulis Sinomenii 300g.
1. take by weighing medical material by composition weight, soak 1h, decocts 2 times, decoct 1h at every turn, one fries in shallow oil and adds 14 times in water, and two fry in shallow oil 10 times of amount of water, merge decoction liquor, filter, and filtrating and being concentrated into relative density is 1.05～1.07 extractum liquid, subsequent use;
2. add ethanol in the above-mentioned 1. extractum liquid, to concentration of alcohol be 60%.Hold over night, precipitate with ethanol.Filter, filtrating is at 60～70 ℃ of temperature recover ethanol, and to be concentrated into relative density be 1.35～1.40 equivalent extract;
3. above-mentioned 2. equivalent extract is drying under reduced pressure in the time of 60～80 ℃, is ground into fine powder, crosses 60 mesh sieves, promptly gets the active component of medicine of the present invention;
4. get the above-mentioned 3. active component 250～350g of preparation, add microcrystalline Cellulose 101 120～130g, cross-linked carboxymethyl cellulose and receive 20～30g, mixing.Adopt dry granulation, and be pressed into 1000, the bag film-coat is processed tablet, promptly gets.
By the composition weight of implementing and adopt the made Chinese medicinal tablet of above-mentioned method for preparing, every heavy 0.45g, every is equivalent to crude drug 1.75g.Production unit can amplify corresponding multiple in this ratio according to production scale separately.
Embodiment 2
Raw material prescription: Radix Astragali 400g, Herba Epimedii 300g, Herba Ecliptae 300g, Radix Salviae Miltiorrhizae 250g, Radix Achyranthis Bidentatae 250g, Caulis Sinomenii 250g.
1. take by weighing medical material by composition weight, soak 1h, decocts 2 times, decoct 1h at every turn, one fries in shallow oil and adds 14 times in water, and two fry in shallow oil 10 times of amount of water, merge decoction liquor, filter, and filtrating and being concentrated into relative density is 1.05～1.07 extractum liquid, subsequent use;
2. add ethanol in the above-mentioned 1. extractum liquid, to concentration of alcohol be 60%.Hold over night, precipitate with ethanol.Filter, filtrating is at 60～70 ℃ of temperature recover ethanol, and to be concentrated into relative density be 1.35～1.40 equivalent extract;
3. above-mentioned 2. equivalent extract is drying under reduced pressure in the time of 60～80 ℃, is ground into fine powder, crosses 60 mesh sieves, promptly gets the active component of medicine of the present invention;
4. get the above-mentioned 3. active component 250～350g of preparation, add microcrystalline Cellulose 101 120～130g, cross-linked carboxymethyl cellulose and receive 20～30g, mixing.Adopt dry granulation, and be pressed into 1000, the bag film-coat is processed finished tablet, promptly gets.
Embodiment 3
Raw material prescription: Radix Astragali 350g, Herba Epimedii 250g, Herba Ecliptae 250g, Radix Salviae Miltiorrhizae 200g, Radix Achyranthis Bidentatae 200g, Caulis Sinomenii 200g.
1. take by weighing medical material by composition weight, soak 1h, decocts 2 times, decoct 1h at every turn, one fries in shallow oil and adds 14 times in water, and two fry in shallow oil 10 times of amount of water, merge decoction liquor, filter, and filtrating and being concentrated into relative density is 1.05～1.07 extractum liquid, subsequent use;
2. add ethanol in the above-mentioned 1. extractum liquid, to concentration of alcohol be 60%.Hold over night, precipitate with ethanol.Filter, filtrating is at 60～70 ℃ of temperature recover ethanol, and to be concentrated into relative density be 1.35～1.40 equivalent extract;
3. above-mentioned 2. equivalent extract is drying under reduced pressure in the time of 60～80 ℃, is ground into fine powder, crosses 60 mesh sieves, promptly gets the active component of medicine of the present invention;
4. get the above-mentioned 3. active component 250～350g of preparation, add microcrystalline Cellulose 101 120～130g, cross-linked carboxymethyl cellulose and receive 20～30g, mixing.Adopt dry granulation, and be pressed into 1000, the bag film-coat is processed tablet, promptly gets.
By the composition weight of implementing and adopt the made Chinese medicinal tablet of above-mentioned method for preparing, every heavy 0.45g, every is equivalent to crude drug 1.75g.Production unit can amplify corresponding multiple in this ratio according to production scale separately.
Embodiment 4
Radix Astragali 300g, Herba Epimedii 200g, Herba Ecliptae 200g, Radix Salviae Miltiorrhizae 150g, Radix Achyranthis Bidentatae 150g, Caulis Sinomenii 150g.
1. take by weighing medical material by composition weight, soak 1h, decocts 2 times, decoct 1h at every turn, one fries in shallow oil and adds 14 times in water, and two fry in shallow oil 10 times of amount of water, merge decoction liquor, filter, and filtrating and being concentrated into relative density is 1.05～1.07 extractum liquid, subsequent use;
2. add ethanol in the above-mentioned 1. extractum liquid, to concentration of alcohol be 60%.Hold over night, precipitate with ethanol.Filter, filtrating is at 60～70 ℃ of temperature recover ethanol, and to be concentrated into relative density be 1.35～1.40 equivalent extract;
3. above-mentioned 2. equivalent extract is drying under reduced pressure in the time of 60～80 ℃, is ground into fine powder, crosses 60 mesh sieves, promptly gets the active component of medicine of the present invention;
4. get the above-mentioned 3. active component 350～250g of preparation, add microcrystalline Cellulose 101 120～130g, cross-linked carboxymethyl cellulose and receive 20～30g, mixing.The method that is used in is granulated, and is pressed into 1000, and the bag film-coat is processed finished tablet, promptly gets.
Embodiment 5
Radix Astragali 250g, Herba Epimedii 150g, Herba Ecliptae 150g, Radix Salviae Miltiorrhizae 150g, Radix Achyranthis Bidentatae 100g, Caulis Sinomenii 100g (crude drug dosage).
1. take by weighing medical material by composition weight, soak 1h, decocts 2 times, decoct 1h at every turn, one fries in shallow oil and adds 14 times in water, and two fry in shallow oil 10 times of amount of water, merge decoction liquor, filter, and filtrating and being concentrated into relative density is 1.05～1.07 extractum liquid, subsequent use;
2. add ethanol in the above-mentioned 1. extractum liquid, to concentration of alcohol be 60%.Hold over night, precipitate with ethanol.Filter, filtrating is at 60～70 ℃ of temperature recover ethanol, and to be concentrated into relative density be 1.35～1.40 equivalent extract;
3. above-mentioned 2. equivalent extract is drying under reduced pressure in the time of 60～80 ℃, is ground into fine powder, crosses 60 mesh sieves, promptly gets the active component of medicine of the present invention;
4. get the above-mentioned 3. active component 350～250g of preparation, add microcrystalline Cellulose 101 120～130g, cross-linked carboxymethyl cellulose and receive 20～30g, mixing.Adopt dry granulation, and be pressed into 1000, the bag film-coat is processed finished tablet, promptly gets.
Embodiment 6
With gained active component in embodiment 1,2 or 3, pulverize by conventional method, add dextrin, granulate behind the mix homogeneously, 60～65 ℃ of dryings, granulate promptly gets.
Embodiment 7
With gained active component in embodiment 1,2 or 3, pulverize by conventional method, add microcrystalline Cellulose, calcium carbonate, mix homogeneously incapsulates.
Embodiment 8
With gained active component in embodiment 1,2 or 3, pulverize by conventional method, add disintegrating agents such as carboxymethyl starch sodium, guar gum, sodium alginate, granulate or direct compression.
Embodiment 9
With gained active component in embodiment 1,2 or 3, pulverize by conventional method, add adjuvants such as stevioside, Tween 80, add water to capacity, filter packing.
The embodiment 10 compound preparation treatment relevant pharmacological researches of back pain caused by senile osteoporosis () of the present invention compound preparation of the present invention (is called for short: the detumescence strong close osteocomma of waist), analgesic experiment research
1, medicine: strong four kinds of concentration of the close osteocomma of waist: 2 multiple dose groups, etc. multiple dose group, 0.5 multiple dose group, 0.25 multiple dose group and normal saline group relatively, by the kg body weight conversion, dosage is equivalent to clinical 60KG body weight patient dosage; Dosage is confirmed " herbal medicine efficacy research thinking and method " P18-19 according to people and animal body surface conversion relation, and " modern medicine experimental zoology P335 " is equivalent to clinical equivalent dosage.Dosage is confirmed according to people and animal body surface conversion relation, is waited multiple dose group dosage to be equivalent to clinical equivalent dosage.
2, laboratory animal: Male Kunming strain mice, cleaning level (department of the Chinese Academy of Sciences of laboratory animal section of Fudan University, credit number: Scxk Shanghai 2003-0003, the laboratory animal certification of fitness: 0019761); Body weight: 20 ± 2 grams; Number of animals: 12 of every group of mices; Be divided at random: 2 multiple dose groups (14.6g/Kg body weight/day), etc. multiple dose group (7.3g/Kg body weight/day), 0.5 multiple dose group (3.65g/Kg body weight/day), 0.25 multiple dose group (1.825g/Kg body weight/day), normal saline group.The every 10g body weight of dosage administration 0.1ml, effect experiment is carried out in administration 3 days, last administration after 1 hour.
1. mice hot-plate analgesic test
Screen qualified mice, mice is placed on the hot plate to the pain threshold of sufficient required time (s) as this Mus occurring licking.All lick the foot the used time less than 5s or greater than 60s or leaper, give it up.Qualified mice is divided into 7 groups at random, surveys its pain threshold again, as the pain threshold before this Mus administration.
Mice fasting 12h before the test, each organizes equal gastric infusion, after the administration 30,60,120min surveys the mice pain threshold respectively.Still reactionless like 60s, mice to be taken out, calculate with 60s its threshold of pain.
The result shows, mice hot plate experiment pain threshold, 2 multiple dose groups, etc. multiple dose group, 0.5 multiple dose group, 0.25 multiple dose group and matched group relatively, 60min and 120min all have significant difference.Each dosage group there was no significant difference, 0.5 multiple dose group is superior to other treatment group.
Table 1 is mice hot-plate analgesic test result.
Table 1
Compare with matched group
*P＜0.05,
*P＜0.01
2. xylene induced mice ear swelling experiment
30min after the last administration, mouse right ear are coated with xylene 0.1ml/ and only cause inflammation, and left ear is contrast; Taking off the neck mortar behind the 15min puts to death; Cut ears along the auricle baseline; The ear same position sweeps away auricle in the left and right sides with the 6mm corneal trephine, and on electronic analytical balance, weigh (being accurate to 0.1mg), auris dextra weight deducts the difference (unit: mg) be the swelling degree of left ear weight; Calculate and respectively to organize average swelling degree and to obtain inhibitory rate of intumesce (%), inhibitory rate of intumesce (100%)=(auris dextra heavy-left ear is heavy)/left ear heavy * 100%.
The result shows: the mice ear suppression ratio, 2 multiple dose groups, etc. multiple dose group, 0.5 multiple dose group and matched group significant difference is relatively arranged, wherein 2 multiple dose groups are superior to 0.5 multiple dose group and wait the multiple dose group.There was no significant difference between each dosage group.
Table 2 is experiment mice ear swelling suppression ratio.
Table 2
Compare with matched group
*P＜0.05,
*P＜0.01
(2) compound preparation of the present invention (is called for short: the cytologic experiment research strong close osteocomma of waist)
A cleaning level SD rat, body weight rat 300 ± 20g (the medical experiment animal certificate of competency that management of laboratory animal committee in Shanghai City issues, the quality certification number: " Shanghai is moving closes the card word No. 152 "; Zoopery environmental facility grade: cleaning level; The environmental facility quality certification number: " the moving word of doctor 02-24 number ").Divide into groups as follows:
(1) negative control group, normal rat serum;
(2) the strong close osteocomma 1/4 multiple dose group rat blood serum (2.1875g/Kg body weight/day) of waist;
(3) the strong close osteocomma 1/2 multiple dose group rat blood serum (4.375g/Kg body weight/day) of waist;
(4) the strong close osteocomma 1 multiple dose group rat blood serum (8.75g/Kg body weight/day) of waist;
(5) the strong close osteocomma 2 multiple dose group rat blood serums (17.5g/Kg body weight/day) of waist;
(6) positive controls, BMP-2 purifying protein (50ng/ml).
1. mtt assay is observed the influence to osteoblastic proliferation: the trophophase osteoblast of taking the logarithm, behind conventional trypsinization, process single cell suspension.Counting cells, the adjustment cell density is 1 * 10
4About/ml.Cell is moved in 96 well culture plates, and every hole 200ml puts into 37 ℃, 5%CO then
2Cultivate in the incubator, the culture fluid in the hole is removed in suction on the secondth, by the administration respectively of above-mentioned group technology, and 8 every group multiple holes; Every hole 200ul pastille serum cell culture fluid afterwards, is put into 37 ℃, 5%CO2 incubator continuation cultivation, after cultivating 48 hours again; Take out culture plate and carry out mtt assay and detect, every hole adds 20ul MTT solution (5mg/ml), after putting into 37 ℃, 5%CO2 incubator and hatching 4 hours, and abandoning supernatant; Every hole adds DMSO 180ul, jolts mixing, and crystallization is dissolved fully; Go up immediately ELIASA and measure the OD value, wavelength is 490nm, is the blank hole with the simple culture fluid of doing simultaneously.
The mtt assay testing result shows: the strong close osteocomma of waist can obviously promote osteoblastic propagation (P＜0.01), and is wherein the most obvious with 1/4 multiple dose.
Table 3 is that the mtt assay observation influences osteoblastic proliferation.
Table 3
Annotate: relatively there is significant difference * P＜0.01 with the normal control group.
2. the real-time fluorescence quantitative PCR reaction detection is to the influence of BMP-2, Type I Collagen and BGP mRNA expression in the osteoblast
Primer is by retrieving the full length gene sequence, then according to factors such as primer length, Tm temperature, the GC% the most suitable primer of design and synthetic among the Genebank data base.Sequence is following:
BMP-2：5’-GATC?TGTA?CCGC?AGGC?ACTC-3’，5’-TTCC?CACT?CATC?TCTG?GAAGTT-3’；Type?I?Collagen：5’-CATT?TGCA?CTGG?GTCA?CACG?TA-3’，5’-GAAT?CTGG?CCAT?GTTT?GTGC?TC-3’；Osteocalcin：5’-CCCT?CTCT?CTGC?TCACTCTG?CT-3’，5’-CTTA?TTGC?CCTC?CTGC?TTGG-3’；β-actin：5’-CTGT?CCCTGTAT?GCCT?CTG-3’，5’-ATGT?CACG?CACG?ATTT?CC-3’。
Sample cDNA is carried out the quantitative fluorescent PCR reaction respectively.After question response finishes, carry out the absolute quantitation analysis automatically according to standard curve, and result of calculation, carry out relatively with the ratio of the copy number of the copy number of the contained genes of interest of each sample and its β-actin internal control gene with Rotor Gene6.0 software.
The real-time fluorescence quantitative PCR reaction result shows that the strong close osteocomma of waist can promote the expression (P＜0.01) of osteoblast BMP-2 mRNA, and wherein the most obvious with 1/4 multiple dose, 1/2 multiple dose takes second place; The strong close osteocomma of waist can promote the expression of osteoblast Type I Collagen mRNA, wherein with 2 multiple doses the most obviously (P＜0.01), and 1/4 multiple dose take second place (P＜0.05); The strong close osteocomma of waist can promote the expression (P＜0.01) of osteoblast BGP mRNA, and wherein the most obvious with 1/4 multiple dose, 1/2 multiple dose takes second place.
Table 4 is influences that treatment back BMP-2, Type I Collagen and BGP mRNA express.
Table 4
Annotate:
*Relatively there is significant difference P＜0.05 with the normal control group; * relatively there is extremely significant difference P＜0.01 with the normal control group.
(3) acute toxicity testing
Kunming mice is irritated stomach, and (7.52g crude drug/ml), maximum volume (40ml/kg) administration volume be good for the close osteocomma solution of waist, and 2 administrations in 1 day were observed 14 days continuously, and result's demonstration overt toxicity do not occur and reacts none dead mouse by Cmax.The strong clinical people's consumption of the close osteocomma of waist is 70g (crude drug)/60kg/ day, and through calculating, the oral maximum dosage-feeding of mice is 32.72g dried cream powder/kg, i.e. 600.37g crude drug/kg is equivalent to 513 times of clinical people's consumption (every kg body weight).
Claims (6)
1. a compound preparation of treating back pain caused by senile osteoporosis is made up of effective ingredient and pharmaceutical carrier, it is characterized in that preparing raw materials of effective components medicine and weight proportion thereof and consists of:
The Radix Astragali 450～250g, Herba Epimedii 350～150g, Herba Ecliptae 350～150g, Radix Salviae Miltiorrhizae 300～100g, Radix Achyranthis Bidentatae 300～100g, Caulis Sinomenii 300～100g.
2. press the compound preparation of the described treatment back pain caused by senile osteoporosis of claim 1; The weight proportion scope that it is characterized in that described crude drug is crude drug dosage: the Radix Astragali 400～300g, Herba Epimedii 300～200g, Herba Ecliptae 300～200g, Radix Salviae Miltiorrhizae 250～150g, Radix Achyranthis Bidentatae 250～150g, Caulis Sinomenii 250～150g.
3. by the compound preparation of the described treatment back pain caused by senile osteoporosis of claim 1, it is characterized in that the weight proportion scope of described crude drug is, crude drug dosage:
The Radix Astragali 350～250g, Herba Epimedii 250～150g, Herba Ecliptae 250～150g, Radix Salviae Miltiorrhizae 200～100g, Radix Achyranthis Bidentatae 200～100g, Caulis Sinomenii 200～100g.
4. the method for preparing of the compound preparation of claim 1 or 2 or 3 treatment back pain caused by senile osteoporosis is characterized in that through the following step:
1. take by weighing medical material by composition weight, soak 1h, decoct each 0.5～1.5h 1～3 time; One fries in shallow oil and adds 10～14 times in water, and two, three fry in shallow oil and add 6～10 times in water, merge decoction liquor, filter; Under 60～70 ℃ of temperature, it is 1.05～1.30 extractum that filtrating is concentrated into relative density, subsequent use;
2. add ethanol in the above-mentioned 1. extractum liquid, to concentration of alcohol be 50%～80%, hold over night, precipitate with ethanol filters, filtrating is at 60～80 ℃ of temperature recover ethanol, and to be concentrated into relative density be 1.35～1.40 equivalent extract;
3. above-mentioned 2. equivalent extract is drying under reduced pressure in the time of 60～80 ℃, is ground into fine powder, crosses 60 mesh sieves, gets the medicine activity component extract powder;
4. get the above-mentioned active component extract powder that 3. makes, add filler, disintegrating agent, mixing adopts dry granulation, and is pressed into 1000, the heavy 0.45g of sheet, and the bag film-coat is processed tablet.
5. the method for preparing of the compound preparation of treatment back pain caused by senile osteoporosis according to claim 4 is characterized in that said filler is a microcrystalline Cellulose 101, and addition is 120～130g; Disintegrating agent is a cross-linking sodium carboxymethyl cellulose, and addition is 20～30g.
6. by the compound preparation of the described treatment back pain caused by senile osteoporosis of claim 1, it is characterized in that also processing granule, capsule, mixture or powder.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200910004167 CN101590109B (en) | 2008-09-04 | 2009-02-13 | Compound preparation for treating back pain caused by senile osteoporosis and preparation method thereof |
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200810042554 | 2008-09-04 | ||
| CN200810042554.2 | 2008-09-04 | ||
| CN 200910004167 CN101590109B (en) | 2008-09-04 | 2009-02-13 | Compound preparation for treating back pain caused by senile osteoporosis and preparation method thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN101590109A CN101590109A (en) | 2009-12-02 |
| CN101590109B true CN101590109B (en) | 2012-06-06 |
Family
ID=41405108
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200910004167 Active CN101590109B (en) | 2008-09-04 | 2009-02-13 | Compound preparation for treating back pain caused by senile osteoporosis and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN101590109B (en) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107184645A (en) * | 2016-03-15 | 2017-09-22 | 上海中医药大学附属龙华医院 | It is a kind of to treat compound Chinese medicinal preparation of osteoporotic fracture and its production and use |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1994392A (en) * | 2006-01-06 | 2007-07-11 | 刘子响 | Compound drynaria capsule and tablet and preparation method thereof |
| CN101053608A (en) * | 2006-04-12 | 2007-10-17 | 杨义澄 | 'Gushukang' micropills and its preparation technology |
-
2009
- 2009-02-13 CN CN 200910004167 patent/CN101590109B/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1994392A (en) * | 2006-01-06 | 2007-07-11 | 刘子响 | Compound drynaria capsule and tablet and preparation method thereof |
| CN101053608A (en) * | 2006-04-12 | 2007-10-17 | 杨义澄 | 'Gushukang' micropills and its preparation technology |
Non-Patent Citations (1)
| Title |
|---|
| 吴学文.从虚、瘀论治骨质疏松性腰痛58例.《吉林中医药》.2005,第25卷(第6期),22. * |
Also Published As
| Publication number | Publication date |
|---|---|
| CN101590109A (en) | 2009-12-02 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN1742939B (en) | Medicine for treating pulmonary fibrosis and preparing method | |
| CN104645132A (en) | Traditional Chinese medicine composition for treating diabetic nephropathy, preparation method, traditional Chinese medicine preparation and application of traditional Chinese medicine composition | |
| CN1327875C (en) | Chinese medicine formulation for treating chronic pelvic inflammation and its preparing method | |
| CN102579999A (en) | Medicine for treating carcinous fever and preparation method thereof | |
| CN101700321B (en) | Chinese herbal composition for curing HIV and preparation method thereof | |
| CN101590109B (en) | Compound preparation for treating back pain caused by senile osteoporosis and preparation method thereof | |
| CN102526631B (en) | Traditional Chinese medicine preparation, tablet and capsule for curing dilated cardiomyopathy and preparation method | |
| CN103239562A (en) | Traditional Kazak medicament composition for treating diabetes mellitus and preparation method of traditional Kazak medicament composition | |
| CN102743703A (en) | Medicament for treating cervical spondylosis and preparation method thereof | |
| CN103751650B (en) | One treats paracmastic Chinese medicine composition of gout and preparation method thereof | |
| CN105833055A (en) | Traditional Chinese medicine composition for treating hypertension, hyperlipidemia and hyperglycemia and preparing method and application thereof | |
| CN101732469B (en) | Application of Chinese medicinal composition in preparation of medicament for treating aphonia | |
| CN101028311B (en) | Use of selaginella tamariscina | |
| CN104888153A (en) | Traditional Chinese medicine preparation for treating hepatic hemangioma and preparation method therefor | |
| CN101264237A (en) | Medicaments assembly for recuperating sub-health and preparation thereof | |
| CN1327874C (en) | Chinese medicine formulation for treating chronic prostatitis and its preparing method | |
| CN103816466A (en) | Traditional Chinese medicine composition for treating chest stuffiness and pains as well as preparation and preparation method thereof | |
| CN102727624B (en) | New application of enteritis peaching composition on treatment of chronic prostatitis | |
| CN101693096A (en) | Medicament for treating liver cancer and preparation method thereof | |
| CN101637533B (en) | Application of Chinese medicinal composition in preparation of medicament for treating virus myocarditis | |
| CN102058764B (en) | Medicinal composition for treating acquired immune deficiency syndrome (AIDS) and application thereof | |
| CN101468124A (en) | Chinese medicinal composition for preventing and treating menoxenia and method for preparing the same | |
| CN102018849A (en) | Traditional Chinese medicine composition for preventing irregular menstruation and preparation method thereof | |
| CN105288050A (en) | Medicine for treating cancer | |
| CN107233410B (en) | Traditional Chinese medicine composition for treating rheumatoid arthritis |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C53 | Correction of patent for invention or patent application | ||
| CB03 | Change of inventor or designer information |
Inventor after: Wang Yongjun Inventor after: Lu Sheng Inventor after: Duan Xiaokun Inventor after: Shu Bing Inventor after: Bian Qin Inventor after: Liang Qianqian Inventor after: Hou Wei Inventor after: Xu Hao Inventor after: Yang Zhu Inventor after: Shi Qi Inventor after: Zhang Ning Inventor after: Tang Dezhi Inventor after: Jiang Xueqin Inventor after: Cui Xuejun Inventor after: Zhou Quan Inventor after: Li Chenguang Inventor after: Zhou Zhongjian Inventor before: Wang Yongjun Inventor before: Lu Sheng Inventor before: Duan Xiaokun Inventor before: Shu Bing Inventor before: Bian Qin Inventor before: Liang Qianqian Inventor before: Hou Wei Inventor before: Shi Qi Inventor before: Zhang Ning Inventor before: Tang Dezhi Inventor before: Jiang Xueqin Inventor before: Cui Xuejun Inventor before: Zhou Quan Inventor before: Li Chenguang Inventor before: Zhou Zhongjian |
|
| COR | Change of bibliographic data |
Free format text: CORRECT: INVENTOR; FROM: WANG YONGJUN SHI QI ZHANG NING TANG DEZHI JIANG XUEQIN CUI XUEJUN ZHOU QUAN LI CHENGUANG ZHOU ZHONGJIAN LU SHENG DUAN XIAOXIAO SHU BING BIAN QIN LIANG QIANQIAN HOU WEI TO: WANG YONGJUN SHI QI ZHANG NING TANG DEZHI JIANG XUEQIN CUI XUEJUN ZHOU QUAN LI CHENGUANG ZHOU ZHONGJIAN LU SHENG DUAN XIAOXIAO SHU BING BIAN QIN LIANG QIANQIAN HOU WEI XU HAO YANG ZHU |
|
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| ASS | Succession or assignment of patent right |
Owner name: HEHUANG PHARMACEUTICAL CO., LTD., SHANGHAI Effective date: 20150828 |
|
| C41 | Transfer of patent application or patent right or utility model | ||
| TR01 | Transfer of patent right |
Effective date of registration: 20150828 Address after: 200032 Shanghai Wanping Road No. 725 Patentee after: Longhua Hospital, attached to Shanghai Chinese Medical and Medicinal Univ. Patentee after: Hehuang Pharmaceutical Co., Ltd., Shanghai Address before: 200032 Shanghai Wanping Road No. 725 Patentee before: Longhua Hospital, attached to Shanghai Chinese Medical and Medicinal Univ. |