CN103006957A - Pharmaceutical composition for preventing and treating osteoporosis and preparation method thereof - Google Patents
Pharmaceutical composition for preventing and treating osteoporosis and preparation method thereof Download PDFInfo
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Abstract
The invention relates to a pharmaceutical composition for preventing and treating osteoporosis and a preparation method thereof. The pharmaceutical composition is composed of pseudo-ginseng, dragons blood, safflower, Salvia miltiorrhiza, epimeddium, morinda officinalis, Radix Codonopsis, bighead atractylodes rhizome, rhizoma drynariae, himalayan teasel root and licorice. The pharmaceutical composition had efficacies of tonifying Qi and the kidney, promoting blood circulation, removing stasis, strengthening muscles and bones, and relieving swelling and pain, and can be used for preventing and treating the osteoporosis.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition; More specifically say a kind of effect with QI invigorating kidney tonifying, blood circulation promoting and blood stasis dispelling, bone and muscle strengthening, reducing swelling and alleviating pain, be used for prevention and treat osteoporotic pharmaceutical composition and preparation method thereof; Belong to medical technical field.
Background technology
Along with China's population constantly enters aging, osteoporosis becomes one of disease of old people's maximum, this disease is not only so that the improve of old people's medical expense, and be easy to cause old people's fracture, that have even caused the old people to lose self care ability, caused serious living burden to the household.Prevention of osteoporosis disease should cause the sufficient attention of old people and society.
WHO statistics shows, the patients with osteoporosis sum surpasses 200,000,000 people in the world wide at present, and wherein only just there are more than 7,500 ten thousand people in the U.S., West Europe and Japan, annual flower in treatment and the expense on being in hospital up to 25,000,000,000 dollars.The sickness rate of all ages and classes section osteoporosis is followed successively by: 50～60 years old be 21%, 60～70 years old be nearly to be 100% more than 58%, 70 years old.China in recent years sickness rate of osteoporosis (comprise low sclerotin person) is the gesture that rises overally, and total number of the infected rises to 100,000,000 people in 2007 by 6,300 ten thousand people in 1992, accounts for national total number of persons nearly 8%.
Anti-absorption treatment is adopted in the treatment of osteoporosis at present, and it reaches the purpose for the treatment of by reducing bone resorption rate.To patient with severe symptoms, high-risk patient and the patient that fractured, the therapeutic effect of anti-absorption is limited.
Motherland's medical science thinks, primary osteoporosis belongs to the traditional Chinese medical science " atrophic debility of bones " category.Studies show that, osteoporosis is apt to occur in above people of 4O year, has 15% to suffer from osteoporosis in the middle-aged and elderly people, and along with the age increases sickness rate and also increases gradually, this just should with suffer from a deficiency of the kidney theory with Senescence of theory of Chinese medical science towel.It is the record of " the congenital foundation ", " kidney producing bone marrow ", " it fills at bone " that kidney is just arranged in " the large opinion of YIN YANG classification of natural phenomena " of Huangdi's Internal Classics.More explicitly pointed out to suffer from a deficiency of the kidney in " Plain Questions O flaccidity opinion " and caused the pathogenesis of osteopathia: ".Heat in the kidney, then spinal column can not be lifted, bone is withered and marrow subtracts, and sends out to be the atrophic debility of bones ".Therefore, suffering from a deficiency of the kidney is that osteoporosis is fallen ill originally.Simultaneously, theory of Chinese medical science is emphasized " organic conception ", and the discussion of " the kidney being the origin of congenital constitution ", " the spleen being the foundation of acquired constitution " is early arranged.Therefore. emphasize to suffer from a deficiency of the kidney be the osteoporosis Etiological in, it should be noted that insufficiency of the spleen also is the Important cause of disease of primary disease.Simultaneously, Liver and kidney has saying of " essence and blood sharing the same origin ".Therefore the fierce pathogenesis key of osteoporotic disease is relevant at kidney and liver, spleen, stomach.
Medicine of the present invention is the effect of QI invigorating kidney tonifying, blood circulation promoting and blood stasis dispelling, bone and muscle strengthening, reducing swelling and alleviating pain, is used for prevention and treats osteoporotic pharmaceutical composition.
Curative effect of medication of the present invention is good, and the adaptation population is wide, therefore is necessary to develop this class Prospect of TCM New Products.
Summary of the invention
Purpose of the present invention just provides a kind of osteoporosis agents composition and method of making the same for the treatment of, and this pharmaceutical composition has the effect of QI invigorating kidney tonifying, blood circulation promoting and blood stasis dispelling, bone and muscle strengthening, reducing swelling and alleviating pain, and clinical practice is in the treatment osteoporosis.This pharmaceutical composition can be prepared into different dosage form for needs of patients in addition, is convenient to take, and is easy to carry.
For achieving the above object, the pharmaceutical composition of prevention provided by the invention and treatment osteoporosis is prepared from by the processing of the crude drug of following weight parts: Radix Notoginseng 100-150 part, Flos Carthami 30-80 part, Sanguis Draxonis 30-80 part, Herba Epimedii 100-150 part, Radix Morindae Officinalis 100-150 part, Radix Codonopsis 50-100 part, Rhizoma Atractylodis Macrocephalae 50-100 part, Rhizoma Drynariae 30-80 part, Radix Dipsaci 30-80 part, Radix Salviae Miltiorrhizae 30-80 part, Radix Glycyrrhizae 20-50 part.
Preferred plan is prepared from by the processing of the crude drug of following weight parts: 125 parts of Radix Notoginseng, 55 parts on Flos Carthami, 55 parts of Sanguis Draxonis, 120 parts of Herba Epimedii, 120 parts of Radix Morindae Officinaliss, 75 parts of Radix Codonopsis, 75 parts of the Rhizoma Atractylodis Macrocephalaes, 50 parts of Rhizoma Drynariae, 50 parts of Radix Dipsacis, 50 parts of Radix Salviae Miltiorrhizaes, 30 parts in Radix Glycyrrhizae.
The pharmaceutical composition of prevention of the present invention and treatment osteoporosis can be made various oral formulations according to conventional method, comprises being prepared into capsule, tablet, granule.
Described weight portion can be the weight metering units such as gram, two, jin, kilogram, ton.
Pharmaceutical composition of the present invention can adopt the ingredients of conventional method in will writing out a prescription to carry out in proportion compatibility, makes various clinical applicable dosage forms by existing preparation process, and used ingredients is the Chinese crude drug that commercially available process is up to the standards.
Preparation method of the present invention comprises the steps:
(1) Radix Notoginseng, Sanguis Draxonis, Flos Carthami, Radix Salviae Miltiorrhizae are ground into respectively fine powder, and be for subsequent use;
(2) all the other Herba Epimedii, Radix Morindae Officinalis, Radix Codonopsis, the Rhizoma Atractylodis Macrocephalae, Rhizoma Drynariae, Radix Dipsaci, Radix Glycyrrhizae etc. seven flavor adds 4～6 times of decoctings and boils three times, 2 hours for the first time, second and third time each 1 hour, collecting decoction filters, filtrate is concentrated into the clear paste that relative density is 1.10～1.15 (60 ℃), adding ethanol in the clear paste is 50～70% to containing the alcohol amount again, leaves standstill 12 hours precipitations, filtration, filtrate recycling ethanol to nothing alcohol is distinguished the flavor of, and is condensed into the extractum that relative density is 1.15 (60 ℃);
(3) in above-mentioned extractum, add fine powder described in (1), mixing, cold drying in the time of 60～80 ℃ is ground into fine powder; Cross 60 mesh sieves, obtain the pharmaceutically active extract powder;
(4) get the pharmaceutically active extract powder that above-mentioned (3) make, add filler, disintegrating agent, mixing, adopt dry granulation, and be pressed into 1000, every heavy 0.35g; Or 1000 of filled capsules, every heavy 0.35g; Or granulation 1000g.
The preparation method of pharmaceutical composition of the present invention, can avoid decoction to take front interim decoction, be long placed in and easily go mouldy and bring a lot of inconveniences to the patient, according to the physicochemical property of main flavour of a drug in clinical application characteristics, the preservation prescription and in conjunction with the modern pharmaceutical technology, make the solid preparations such as tablet, capsule, granule, the demand that has satisfied the patient easily and effectively.
Why the present invention selects above-mentioned medical material as raw material, is because they have following effect:
Radix Notoginseng: dissipating blood stasis hemostasis, subduing swelling and relieving pain.Be used for spitting of blood, spit blood, epistaxis is had blood in stool, metrorrhagia, and traumatic hemorrhage, the breast abdomen twinges, tumbling and swelling.
Flos Carthami: promoting blood circulation to restore menstrual flow, eliminating stasis to stop pain.Be used for amenorrhea, dysmenorrhea, lochia ， mass in the abdomen mass in the abdomen, injury from falling down, skin infection swells and ache.
Sanguis Draxonis: the resin in babassu Sanguis Draxonis fruit and the rattan; Has promoting blood circulation to remove blood stasis, analgesic therapy, the effect of hemostasia and promoting granulation.
Herba Epimedii: kidney-replenishing, bone and muscle strengthening, wind-damp dispelling.Be used for impotence and seminal emission, the muscles and bones flaccidity is soft, rheumatic arthralgia, numbness contracture; Climacteric hypertension disease.
Radix Morindae Officinalis: kidney-replenishing, bone and muscle strengthening, wind-damp dispelling.Be used for impotence and seminal emission, cold womb is infertile, the few abdomen cold type of pain of menoxenia, and rheumatic arthralgia, the muscles and bones flaccidity is soft.
Radix Codonopsis: invigorating the spleen and replenishing QI, the spleen invigorating lung benefiting is used for deficiency of the spleen and lung, the cardiopalmus of breathing hard, anorexia and loose stool, the dyspnea due to deficiency cough, interior-heat is quenched one's thirst.
The Rhizoma Atractylodis Macrocephalae: invigorating the spleen and benefiting QI, the dampness diuretic, hidroschesis, antiabortive.Be used for insufficiency of the spleen lack of appetite, abdominal distention is had loose bowels, phlegm retention vertigo and palpitation, edema, spontaneous perspiration, frequent fetal movement.The Rhizoma Atractylodis Macrocephalae spleen invigorating, stomach function regulating, antiabortive.Be used for insufficiency of the spleen lack of appetite, the loose stool of having loose bowels, frequent fetal movement.
Rhizoma Drynariae: the kidney invigorating bone strengthening continues and hinders pain relieving.Be used for lumbago due to renal deficiency, Hiccough and deaf, odontoseisis, falling winks frustrates, the muscle fracture wound; The external treatment alopecia areata, vitiligo.
Radix Dipsaci: invigorating the liver and kidney, bone and muscle strengthening, continuous folding is hindered, and ends metrorrhagia.Be used for soreness of the waist and knees, rheumatic arthralgia, the metrorrhagia warp is many, vaginal bleeding during pregnancy hematochezia, injury from falling down.
Radix Salviae Miltiorrhizae: stasis-dispelling and pain-killing, promoting blood circulation to restore menstrual flow, relieving restlessness clears away heart-fire.Be used for menoxenia, amenorrhea dysmenorrhea ， lumps in the chest and abdomen, breast ventral spine pain, pyretic arthralgia pain, skin infection swells and ache, dysphoria and insomnia; Hepatosplenomegaly, angina pectoris.
Radix Glycyrrhizae: invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, expelling phlegm for arresting cough, relieving spasm to stop pain, coordinating the actions of various ingredients in a prescription.Be used for weakness of the spleen and stomach, fatigue and weakness, shortness of breath and palpitation, cough with copious phlegm, gastral cavity abdomen, the anxious pain of extremity contraction, carbuncle sore tumefacting virus, cushion toxicity, strong.
Pharmaceutical composition provided by the invention has the effect of QI invigorating kidney tonifying, blood circulation promoting and blood stasis dispelling, bone and muscle strengthening, reducing swelling and alleviating pain, is used for prevention and treatment osteoporosis.
The specific embodiment
Below with embodiment a kind of pharmaceutical composition for the treatment of osteoporosis of the present invention and preparation method thereof is further described; this will help the present invention and effect thereof are further understood; embodiment does not limit protection scope of the present invention, and its protection domain is decided by claim.
Embodiment 1
Used crude drug is Radix Notoginseng 100g, Flos Carthami 30g, Sanguis Draxonis 30g, Herba Epimedii 100g, Radix Morindae Officinalis 100g, Radix Codonopsis 50g, Rhizoma Atractylodis Macrocephalae 50g, Rhizoma Drynariae 30g, Radix Dipsaci 30g, Radix Salviae Miltiorrhizae 30g, Radix Glycyrrhizae 20g in the present embodiment.
Its preparation method is:
Get Radix Notoginseng, Sanguis Draxonis, Flos Carthami, Radix Salviae Miltiorrhizae and be ground into respectively fine powder, for subsequent use; Seven flavors such as all the other Herba Epimedii, Radix Morindae Officinalis, Radix Codonopsis, the Rhizoma Atractylodis Macrocephalae, Rhizoma Drynariae, Radix Dipsaci, Radix Glycyrrhizae add 4 times of decoctings and boil three times, 2 hours for the first time, second and third time each 1 hour, collecting decoction filters, filtrate is concentrated into the clear paste that relative density is 1.10～1.15 (60 ℃), adding ethanol in the clear paste is 50% to containing the alcohol amount again, leaves standstill 12 hours precipitations, filtration, filtrate recycling ethanol to nothing alcohol is distinguished the flavor of, and is condensed into the extractum that relative density is 1.15 (60 ℃); In above-mentioned extractum, add above-mentioned fine powder, mixing, cold drying in the time of 60 ℃ is ground into fine powder; Cross 60 mesh sieves, obtain the pharmaceutically active extract powder; Add appropriate amount of auxiliary materials, mixing, adopt dry granulation, and be pressed into 1000, every heavy 0.35g.
Embodiment 2
Used crude drug is Radix Notoginseng 150g, Flos Carthami 80g, Sanguis Draxonis 80g, Herba Epimedii 150g, Radix Morindae Officinalis 150g, Radix Codonopsis 100g, Rhizoma Atractylodis Macrocephalae 100g, Rhizoma Drynariae 80g, Radix Dipsaci 80g, Radix Salviae Miltiorrhizae 80g, Radix Glycyrrhizae 50g in the present embodiment.
Its preparation method is:
Get Radix Notoginseng, Sanguis Draxonis, Flos Carthami, Radix Salviae Miltiorrhizae and be ground into respectively fine powder, for subsequent use; Seven flavors such as all the other Herba Epimedii, Radix Morindae Officinalis, Radix Codonopsis, the Rhizoma Atractylodis Macrocephalae, Rhizoma Drynariae, Radix Dipsaci, Radix Glycyrrhizae add 6 times of decoctings and boil three times, 2 hours for the first time, second and third time each 1 hour, collecting decoction filters, filtrate is concentrated into the clear paste that relative density is 1.15 (60 ℃), adding ethanol in the clear paste is 70% to containing the alcohol amount again, leaves standstill 12 hours precipitations, filtration, filtrate recycling ethanol to nothing alcohol is distinguished the flavor of, and is condensed into the extractum that relative density is 1.15 (60 ℃); In above-mentioned extractum, add above-mentioned fine powder, mixing, cold drying in the time of 80 ℃ is ground into fine powder; Cross 60 mesh sieves, obtain the pharmaceutically active extract powder; Add appropriate amount of auxiliary materials, 1000 of filled capsules, every heavy 0.35g.
Embodiment 3
Used crude drug is Radix Notoginseng 125g, Flos Carthami 55g, Sanguis Draxonis 55g, Herba Epimedii 120g, Radix Morindae Officinalis 120g, Radix Codonopsis 75g, Rhizoma Atractylodis Macrocephalae 75g, Rhizoma Drynariae 50g, Radix Dipsaci 50g, Radix Salviae Miltiorrhizae 50g, Radix Glycyrrhizae 30g in the present embodiment.
Its preparation method is:
Get Radix Notoginseng, Sanguis Draxonis, Flos Carthami, Radix Salviae Miltiorrhizae and be ground into respectively fine powder, for subsequent use; Seven flavors such as all the other Herba Epimedii, Radix Morindae Officinalis, Radix Codonopsis, the Rhizoma Atractylodis Macrocephalae, Rhizoma Drynariae, Radix Dipsaci, Radix Glycyrrhizae add 5 times of decoctings and boil three times, 2 hours for the first time, second and third time each 1 hour, collecting decoction filters, filtrate is concentrated into the clear paste that relative density is 1.10 (60 ℃), adding ethanol in the clear paste is 60% to containing the alcohol amount again, leaves standstill 12 hours precipitations, filtration, filtrate recycling ethanol to nothing alcohol is distinguished the flavor of, and is condensed into the extractum that relative density is 1.15 (60 ℃); In extractum, add above-mentioned fine powder, mixing, cold drying in the time of 70 ℃ is ground into fine powder; Cross 60 mesh sieves, obtain the pharmaceutically active extract powder; Add right amount of auxiliary materials, mixing, adopt dry granulation, granulation 1000g.
Be the curative effect of proof pharmaceutical composition of the present invention, the special raw material composition of embodiment 3 that adopts of inventor has carried out following relevant pharmacological research with preparation method:
One, the detumescence of pharmaceutical preparation of the present invention, analgesic test:
1, medicine: four kinds of concentration of medicine of the present invention: 2 multiple dose groups, etc. dosage group, 0.5 multiple dose group, 0.25 multiple dose group and normal saline group relatively, by a kilogram conversion body weight, dosage is equivalent to clinical 60kg body weight patient dosage; Dosage is determined according to man and animal body surface conversion relation, is waited multiple dose group dosage to be equivalent to clinical equivalent dosage.
2, experimental animal: Male Kunming strain mice, cleaning level; Body weight: 20 ± 2g; Number of animals: 10 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, the test of pesticide effectiveness is carried out in administration 3 days, last administration after 1 hour.
The hot plate method in mice analgesic test
Screen qualified mice, mice is placed on the hot plate to occurring adding sufficient required time (s) as the pain threshold of this Mus.Allly add the used time of foot less than 5s, or greater than 60s or leaper, give it up.Qualified mice is divided into 7 groups at random, surveys again its pain threshold, as the pain threshold before the administration.
Mice fasting 12h before the test, each organizes equal gastric infusion, after the administration 30,60,120min surveys respectively the mice pain threshold.Still reactionless such as 60s, mice is taken out, its pain threshold calculates with 60s.
The result shows, hot plate method in mice test pain threshold, 2 multiple dose groups, etc. dosage 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 better than the other treatment group.
Table 1 hot plate method in mice analgesic test result
Compare * P＜0.05, * * P＜0.01 with matched group.
Two, drug cell of the present invention is learned experimental study
Cleaning level SD rat, body weight rat 300 ± 20g; Be grouped as follows:
(1) negative control group, normal rat serum;
(2) medicine 1/4 multiple dose group rat blood serum (2.1875g/kg body weight/day) of the present invention;
(3) medicine 1/2 multiple dose group rat blood serum (4.375g/kg body weight/day) of the present invention;
(4) the multiple dose group rat blood serum (8.75g/kg body weight/day) such as medicine of the present invention;
(5) medicine 2 multiple dose group rat blood serums (17.5g/kg body weight/day) of the present invention;
(6) positive controls, BMP-2 purifying protein (50ng/ml).
1. mtt assay is observed the impact on osteoblastic proliferation: the trophophase osteoblast of taking the logarithm, behind conventional trypsinization, make single cell suspension.Counting cells, adjusting cell density is 1 * 10
4About/ml.Cell is moved in 96 well culture plates, and then every hole 200ml puts into 37 ℃, 5%CO
2Cultivate in the incubator, second day sucks the culture fluid in the hole, by the respectively administration of above-mentioned group technology, and 8 every group multiple holes, every hole 200ul Contained Serum cell culture fluid afterwards, is put into 37 ℃, 5%CO again
2Cultivate in the incubator again, after cultivating 48 hours, take out culture plate and carry out the mtt assay detection, every hole adds 20ulMTT solution (5mg/ml), puts into 37 ℃, 5%CO
2After hatching 4 hours in the incubator, abandoning supernatant, every hole adds DMSO180ul, and the jolting mixing dissolves crystallization fully, go up microplate reader mensuration OD value immediately, and wavelength is 490nm, take the simple culture fluid done simultaneously as the blank hole.
The mtt assay testing result shows, medicine of the present invention can obviously promote osteoblastic propagation (p＜0.01), and is wherein the most obvious with 1/4 multiple dose.
Table 2 mtt assay is observed the impact on osteoblastic proliferation
Annotate: relatively there is significant difference * P＜0.01 with Normal group.
Claims (4)
1. the pharmaceutical composition of a prevention and treatment osteoporosis is characterized in that being prepared from by the processing of the crude drug of following weight parts:
Radix Notoginseng 100-150 part Flos Carthami 30-80 part Sanguis Draxonis 30-80 part Herba Epimedii 100-150 part
Radix Morindae Officinalis 100-150 part Radix Codonopsis 50-100 part Rhizoma Atractylodis Macrocephalae 50-100 part Rhizoma Drynariae 30-80 part
Radix Dipsaci 30-80 part Radix Salviae Miltiorrhizae 30-80 part Radix Glycyrrhizae 20-50 part.
2. the pharmaceutical composition of a kind of prevention according to claim 1 and treatment osteoporosis is characterized in that being prepared from by the crude drug processing of following weight parts:
120 parts of 55 parts of Herba Epimedii of 55 parts of Sanguis Draxonis of 125 parts of Flos Carthamis of Radix Notoginseng
50 parts of 75 parts of Rhizoma Drynariae of 75 parts of Rhizoma Atractylodis Macrocephalaes of 120 parts of Radix Codonopsis of Radix Morindae Officinalis
30 parts in 50 portions of Radix Glycyrrhizaes of 50 parts of Radix Salviae Miltiorrhizaes of Radix Dipsaci.
3. pharmaceutical composition of one of them described a kind of prevention and treatment osteoporosis according to claim 1 and 2 is characterized in that, preparation is capsule, tablet, granule.
4. according to claim 1 or 2 one of them described a kind of preparation method of preventing and treating the pharmaceutical composition of osteoporosis, it is characterized in that comprising the steps:
(1) Radix Notoginseng, Sanguis Draxonis, Flos Carthami, Radix Salviae Miltiorrhizae are ground into respectively fine powder, and be for subsequent use;
(2) all the other Herba Epimedii, Radix Morindae Officinalis, Radix Codonopsis, the Rhizoma Atractylodis Macrocephalae, Rhizoma Drynariae, Radix Dipsaci, Radix Glycyrrhizae etc. seven flavor adds 4～6 times of decoctings and boils three times, 2 hours for the first time, second and third time each 1 hour, collecting decoction filters, filtrate is concentrated into the clear paste that relative density is 1.10～1.15 (60 ℃), adding ethanol in the clear paste is 50～70% to containing the alcohol amount again, leaves standstill 12 hours precipitations, filtration, filtrate recycling ethanol to nothing alcohol is distinguished the flavor of, and is condensed into the extractum that relative density is 1.15 (60 ℃);
(3) in above-mentioned extractum, add fine powder described in (1), mixing, cold drying in the time of 60～80 ℃ is ground into fine powder; Cross 60 mesh sieves, obtain the pharmaceutically active extract powder;
(4) get the pharmaceutically active extract powder that above-mentioned (3) make, add right amount of auxiliary materials, the mixings such as filler, disintegrating agent, adopt dry granulation, and be pressed into 1000, every heavy 0.35g; Or 1000 of filled capsules, every heavy 0.35g; Or granulation 1000g.
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Application publication date: 20130403 |