CN101843668B - Chinese medicinal granules for treating femoral head necrosis and preparation method thereof - Google Patents
Chinese medicinal granules for treating femoral head necrosis and preparation method thereof Download PDFInfo
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Abstract
The invention provides Chinese medicinal granules for treating femoral head necrosis and a preparation method thereof. The Chinese medicinal granules comprise the following raw materials in part by weight: 1,000 to 1,200 parts of astragalus, 1,000 to 1,200 parts of root of red-rooted salvia, 500 to 600 parts of eucommia bark, 1,000 to 1,200 parts of Chinese angelica, 1,000 to 1,200 parts of rhizoma corydalis and 350 to 400 parts of south dodder seed. The Chinese medicinal granules have the effects of tonifying liver and kidney, benefiting vital energy and activating blood, and freeing network vessels and relieving pain, is clinically used for treating ischemic femoral head necrosis at early and middle stages. The Chinese medicinal granules have the characteristics of low hygroscopicity, portability, convenient use, stable quality, small dosage of auxiliary materials and the like. Added flavoring agent can improve mouthfeel of medicaments, and the Chinese medicinal granules are the sugar-free granules, and are convenient for patients (comprising middle and old aged patients with diabetes and obesity) to take for a long time.
Description
(1) technical field: the present invention relates to a kind of Chinese medicine (the strong bone of stilbene ginseng) granule of treating femur head necrosis and preparation method thereof, belong to technical field of traditional Chinese medicine pharmacy.
(2) background technology: femur head necrosis (Osteonecrosis of the Femoral Head; ONFH) be meant owing to reasons such as life-time service hormone, wound, excessive drinking, fatty livers; Thereby cause not enough a kind of orthopaedics commonly encountered diseases and the difficult disease that causes ischemic necrosis of femoral head blood supply; The long disability rate of its course of disease is high; Femur head necrosis is divided into traumatic femur head necrosis and atraumatic femur head necrosis two big classes clinically, and is wherein the most common with atraumatic femur head necrosis (hormone, ethanol etc. cause).Since the 1950's; Along with hormone medicine in clinical extensive use, increase progressively fast by the corticosteroid femur head necrosis due to the hormone, become the first place of the femur head necrosis cause of disease; The femur head necrosis sickness rate rises gradually in recent years, and age of onset has downward trend gradually.The main clinical manifestation of femur head necrosis is hip pain, limping, joint function disturbance; Then be further development of collapse of the femoral head, distortion, osteoarthritis; Finally cause the joint maimed; Cause patient's lifelong disability, had a strong impact on normal work of patient and life, all caused great burden in spirit and economically for patient and family thereof.At present, the Therapeutic Method of femur head necrosis has Drug therapy, interventional therapy, core decompression art, bone grafting, total hip replacement etc.Usually the total hip replacement operation of adopting clinically; Though success rate is higher; But costly (2～50,000/people), and the average life of artificial hip joint has only 10～15 years, needs regularly replace; Metathetical hip joint also may produce complication such as infection, loosening, dislocation, has caused the anaphase effect of operation not ideal enough.And other operative treatments alleviating pain within a certain period of time only, but the process that can not stop course of disease development, worsen.Drug therapy does not still have ideal chemicals so far, and the medicine of clinical practice at present mainly contains fat-reducing medicament, anticoagulant, cell regulating factor, only alleviates, improves symptom, but can not effect a radical cure.In sum; Do not find specific medicament and method as yet for the treatment of femur head necrosis both at home and abroad; Therefore; The method and the medicine of the anti-treating caput femoris necrosis of research and development have important clinic value and realistic meaning, and states such as Japan, the U.S. all classify this disease as unsolved refractory disease, drop into huge fund and carry out the research and development of medicine.
The traditional Chinese medical science is thought; Femur head necrosis belongs to " rheumatism involving the bone ", " osteomyelitis ", is the basic rule of treatment to the treatment of primary disease with " liver and kidney tonifying, blood circulation promoting and blood stasis dispelling, regulating QI to relieve pain ", stresses blood circulation promoting and blood stasis dispelling in early days; Later stage is paid attention to invigorating the kidney and strengthening the bones; Through improving capital blood microcirculation, suppress capillary permeability, promote osteoblastic propagation, reduce intra-osteal pressure, progressively recovering capital normal physiological function, thereby reach the purpose of treating both the principal and secondary aspects of a disease.But the preparation that authentication code is arranged at present only has red strongly fragrant bone health ball, living arteries and veins to become capsule; Clinical most employing is from intending compound preparation; As: strong bone blood activating decoction, the bone soup of living, bone bring back to life soup etc.; Though these prescriptions to early, mid-term femur head necrosis have prevention and therapeutical effect, be limited to the experimental stage mostly, exist in clinical use that dosage form is backward, quality is uncontrollable, curative effect is unstable, take problems such as inconvenience and application limit.At present, the medicine that does not still have specific anti-treating caput femoris necrosis both at home and abroad.Based on the advantages such as toxic and side effects of Chinese medicine primary disease determined curative effect, no wound, no chemicals, from Chinese medicine and natural drug, seek and exploitation has independent intellectual property right, new Chinese medicine safe and effective, treatment femur head necrosis that technology is advanced, stable and controllable for quality has become the emphasis of research and development.
(3) summary of the invention: task of the present invention provides a kind of Chinese medicine granules of effective treatment femur head necrosis; Another task of the present invention provides the method for preparing of this Chinese medicine granules, and this method can be extracted the material medicine effective ingredient than limits, improves drug effect.
The present invention is made up of raw material of Chinese medicine such as the Radix Astragali, Radix Salviae Miltiorrhizae, the Cortex Eucommiae, Radix Angelicae Sinensis, Semen Cuscutae, Rhizoma Corydalis, reuses the invigorating middle warmer of Radix Astragali QI invigorating in the side, gets the reason of QI and blood interpromoting relation in five elements interaction, and QI invigorating stagnates so that hemopoietic is capable, is monarch drug; The Radix Salviae Miltiorrhizae blood circulation promoting and blood stasis dispelling, Cortex Eucommiae invigorating the kidney and strengthening the bones is ministerial drug; Assistant is with Radix Angelicae Sinensis nourishing blood and promoting blood circulation, removing obstruction in the collateral to relieve pain, the Semen Cuscutae liver and kidney tonifying; The Rhizoma Corydalis blood-activating and qi-promoting, through sick institute, blood stasis dispelling is with pain relieving.All medicines share, and play the effect of vital energy benefiting and the kidney invigorating, blood circulation promoting and blood stasis dispelling, removing obstruction in the collateral to relieve pain altogether.
The present invention treats Chinese medicine (the strong bone of the stilbene ginseng) granular preparation of femur head necrosis, and each crude drug weight ratio is: Radix Astragali 1000-1200, Radix Salviae Miltiorrhizae 1000-1200, Cortex Eucommiae 500-600, Radix Angelicae Sinensis 1000-1200, Rhizoma Corydalis 1000-1200, Semen Cuscutae 350-400.
Each crude drug of this Chinese medicine (the strong bone of stilbene ginseng) granular preparation most preferably weight proportion is: the Radix Astragali 1100, Radix Salviae Miltiorrhizae 1100, the Cortex Eucommiae 550, Radix Angelicae Sinensis 1100, Rhizoma Corydalis 1100, Semen Cuscutae 370.
The method for preparing of Chinese medicine of the present invention (the strong bone of stilbene ginseng) granular preparation comprises the steps:
1. material choice
Decoction pieces such as the Radix Astragali, Radix Salviae Miltiorrhizae, Radix Angelicae Sinensis, Rhizoma Corydalis in the prescription are carried out thin layer differentiate (TLC) and HPLC assay, " what require under Chinese pharmacopoeia (an one) the medical material item is qualified decoction pieces, feeds intake to meet 2005 editions;
2, extraction process
Each crude drug mixing was steeped 0.5-2 hour with 6-15 times of water logging, extracts 1-4 time, and each 0.5-2 hour, filter, merging filtrate, being evaporated to relative density is 1.05～1.10 (reduce to and detect the relative density value under the room temperature condition, be generally 20-25 ℃, be as follows);
3, purifying process (precipitate with ethanol)
To the extracting solution that step 2 obtains, add 95% ethanol and make and contain the alcohol amount and be 50-70%, precipitate with ethanol 6-24h reclaims ethanol to there not being the alcohol flavor, and to be evaporated to relative density of medicine liquid be 1.05～1.15;
4, drying process
Medicinal liquid to step 3 obtains is heated to 60 ℃, adds the 1-5% dextrin, and at intake air temperature 140-180 ℃, 70-90 ℃ of air outlet temperature, charging rate are to carry out spray drying under the 40kg/h condition, obtain dry extract;
The spray drying optimal conditions: intake air temperature is that 160 ℃, 80 ℃ of air outlet temperature, charging rate are 40kg/h;
5, moulding process
The dry extract that step 4 is obtained mixes with adjuvant; The mixed proportion of dry extract and adjuvant is 1: 1-4: 1, and be wetting agent with 85-95% ethanol, 30% wetting agent and the 1-2% steviosin that add adjuvant and extractum total amount are processed soft material; Crossing 10 mesh sieves granulates; 55 ℃ of oven dry, granulate, packing gets product.Adjuvant of the present invention is the compound of dextrin and lactose, and its weight ratio is 2: 1.
In product research, the applicant finds, has problems such as patients such as carrying after inconvenience, perishable, the sugaring diabetes should not take if process oral liquid, and its suitable colony is reduced, and clinical use is influenced.So the present invention is made into granule, have carry, taking convenience, help divided dose, steady quality; And add steviosin as correctives, not only improved mouthfeel, and enlarged suitable colony.For this reason; The applicant has carried out the The effects of system to preparation technology of the present invention; The rate of transform with the effective ingredient salvianolic acid B of the effective ingredient astragaloside of the monarch drug Radix Astragali in the side, ministerial drug Radix Salviae Miltiorrhizae is an evaluation index; Investigate the influence of medical material granularity, soak time, amount of water, extraction time and extraction time through single factor experiment and orthogonal test; (weight coefficient is an astragaloside: salvianolic acid B=0.6: 0.4), confirm the optimum extraction process of the strong osseous granules of stilbene ginseng, and optimised process is carried out 3 batches of demonstration tests to adopt the aggregative weighted point system.Investigate the influence of concentration of alcohol, relative density of medicine liquid, precipitate with ethanol time, confirm best purifying process purifying process; Compare spray drying, microwave drying and three kinds of drying meanss of drying under reduced pressure; Confirm to adopt spray drying method; To get powder rate, the index components rate of transform and appearance character is evaluation index; Further investigate the influence of factors such as medicinal liquid density, intake air temperature, air outlet temperature, charging rate and dextrin consumption, confirm the spray drying optimal processing parameter; In Study on Forming, the factors such as ratio, wetting agent and correctives so that single factor experiment screens proportioning, adjuvant and the extract powder of each single adjuvant, different auxiliary material composition mixed accessories on the basis of single factor experiment, adopt L
9(3
4) orthogonal test investigates adjuvant and the ratio of extractum, the concentration and the consumption of wetting agent; With ratio of briquetting, dissolubility, angle of repose, granulation complexity and mouthfeel etc. is evaluation index; Confirm the molding technological condition of the strong osseous granules of stilbene ginseng; And, produce test agent in 3 batches of strong osseous granuleses of stilbene ginseng according to determined preparation technology, carry out quality standard and preliminarily stabilised Journal of Sex Research.
For this reason, the applicant selects to have carried out relevant experimental study with adjuvant to the preparation technology of preparation of the present invention, and is specific as follows:
Test 1: extraction process is investigated
The applicant finds in the product research process, and the amount of water of preparation of the present invention, extraction time, extraction time influence extraction ratio of effective constituents, so extraction conditions is investigated.
1, adopts orthogonal test to carry out preferably, investigate the influence of amount of water, extraction time and extraction time, by 4 factors, 3 horizontal L
9(3
4) table carries out orthogonal test.
Extraction process factor level table
Get prescription ratio medical material, under the operation repetitive condition, press L respectively
9(3
4) 9 experimental conditions arranging of orthogonal table carry out; The rate of transform with the effective ingredient salvianolic acid B of the effective ingredient astragaloside of the monarch drug Radix Astragali under each factor level, ministerial drug Radix Salviae Miltiorrhizae is an evaluation index; (weight coefficient is an astragaloside: the optimum extraction process of salvianolic acid B=0.6: 0.4) confirming the strong osseous granules of stilbene ginseng with the aggregative weighted point system; Carry out variance analysis, consider, draw optimum extraction process in conjunction with big production practical situation and energy consumption.
2, test method
Take by weighing technology under the recipe quantity and investigate 9 parts of the decoction pieces of consumption, every part of 145g soaks 1.0h, by above-mentioned EXPERIMENTAL DESIGN, makes an experiment, and investigates the influence of amount of water, extraction time, extraction time, confirms optimum extraction process.
Extraction process L
9(3
4) orthogonal experiments
Extraction process L
9(3
4) orthogonal experiment plan takes into account statistical disposition
Variance analysis
F
0.05(2，2)＝19；F
0.01，(2，2)＝99
Intuitive analysis shows that each factor effect primary and secondary is C (extraction time)＞A (amount of water)＞B (extraction time), i.e. extraction time influence is the most remarkable, secondly is amount of water, and the extraction time influence is minimum, and optimum extraction process is C
3A
3B
3Variance analysis shows that extraction time has the significance influence, and amount of water and extraction time do not have statistically-significant difference.Because of B
1And B
3Differ very little, consider that from big production practical situation and energy consumption the best extraction process by water of confirming is C
3A
3B
1,, extract 3 times each 0.5h promptly with 12 times of water yields.Said extracted liquid is evaporated to relative density 1.05-1.10, carries out purification.
Test 2: purifying process is investigated
1, orthogonal test is preferred, adopts ethanol precipitation, investigates the influence of concentration of alcohol (containing the alcohol amount), precipitate with ethanol time and medicinal liquid density, by 4 factors, 3 horizontal L
9(3
4) table carries out orthogonal test.
Purifying process factor level table
Get prescription ratio medical material, under the operation repetitive condition, extract, extracting solution is equally divided into 9 parts, press L respectively by the optimum extraction process condition of confirming
9(3
4) 9 experimental conditions arranging of orthogonal table carry out, and are evaluation index with the rate of transform of astragaloside, salvianolic acid B under each factor level, with reference to yield of extract, the result are analyzed, and confirm best purifying process.
2, test method
Take by weighing technology under the recipe quantity and investigate 9 parts of the decoction pieces of consumption, 1305g altogether extracts by the optimum extraction process of confirming that (that is: decoction pieces adds 12 times of water gagings; Soak 1h, reflux, extract, 3 times, each 0.5h); Extracting solution is equally divided into 9 parts, is evaporated to certain density respectively, adopts above-mentioned EXPERIMENTAL DESIGN; Make an experiment, investigate the influence of concentration of alcohol (containing the alcohol amount), precipitate with ethanol time and medicinal liquid density, confirm best purifying process.
Purifying process L
9(3
4) orthogonal experiments
Purifying process L
9(3
4) orthogonal experiment plan takes into account statistical disposition
Variance analysis
F
0.05，(2，2)＝19；F
0.01，(2，2)＝99
Intuitive analysis shows that each effect of factors primary and secondary is C (medicinal liquid density)＞A (concentration of alcohol)＞B (precipitate with ethanol time), i.e. relative density of medicine liquid influence is the most remarkable, secondly is concentration of alcohol (containing the alcohol amount), and the precipitate with ethanol time effects is minimum.Variance analysis shows that factor C (medicinal liquid density) has significant difference, factor A (precipitate with ethanol time) and factor B (relative density of medicine liquid) there was no significant difference; Confirm that best purifying process is C
1A
1B
3, promptly being evaporated to relative density of medicine liquid is 1.05～1.10, adds 95% ethanol and makes that to contain alcohol amount be 50%, precipitate with ethanol 24h.The medicinal liquid of purification gained reclaims ethanol to there not being the alcohol flavor, and to be evaporated to relative density of medicine liquid be 1.05～1.15, carries out spray drying.
Test 3: moulding process
The selection of suitable excipients is to make the particulate key of high-quality; Should take into full account the influence of adjuvant to preparation; Comprise mouldability, hygroscopicity and stability etc., adjuvant should be a principle with having no adverse effects with the Minimal Application amount, and considers cost; Fully satisfying the preparation process requirement, guaranteeing under the product quality premise consumption of adjuvant to be minimized.The present invention finds that the hydroscopicity and the ratio of briquetting of lactose and dextrin obviously is superior to starch and carboxymethyl starch sodium when investigating supplementary product kind; The ratio of briquetting of lactose is superior to dextrin, but the too late dextrin of hydroscopicity, and be prone to liquefaction after the lactose moisture absorption, particle adhesion, moreover the lactose price is higher.Therefore; Single adjuvant can not solve problems such as molding particles rate, hydroscopicity, melting fully; Form mixed accessories so select lactose and dextrin to mix, further investigate its influence, confirm the composition of The Best Mixed adjuvant grain forming rate, hydroscopicity and melting according to different proportion.
1, the factors such as ratio, wetting agent and correctives of forming proportioning, adjuvant and the extract powder of mixed accessories with each single adjuvant of single factor experiment screening, different auxiliary material; On the basis of single factor experiment, adopt orthogonal test preferred, investigate the adjuvant and the ratio of extractum, the concentration and the consumption of wetting agent, by 4 factors, 3 horizontal L
9(3
4) table carries out orthogonal test.
Moulding process factor level table
With ratio of briquetting, dissolubility, angle of repose, granulation complexity and mouthfeel etc. is evaluation index, confirms the molding technological condition of the strong osseous granules of stilbene ginseng.
2, test method
With ethanol is wetting agent, adopts L
9(3
4) orthogonal test carries out the optimization of molding technological condition, investigates the extractum and the ratio of adjuvant, the concentration and the consumption of wetting agent, its ratio of briquetting, granulation situation and melting are investigated.
Moulding process L
9(3
4) orthogonal experiments
The ratio of briquetting variance analysis
F
0.05，(2，2)＝19；F
0.01，(2，2)＝99
Orthogonal test granulation situation and melting result
See that from intuitive analysis the ratio of extractum and adjuvant, the concentration of wetting agent and consumption are remarkable to the ratio of briquetting influence, influence is A＞B＞C in proper order; The scale effect that is extractum and adjuvant is the most remarkable; Next is the concentration of wetting agent, and the consumption influence of wetting agent is minimum, and best moulding process is A
2B
3C
3The results of analysis of variance shows, there were significant differences to the influence of the ratio of briquetting of moulding process for the ratio of extractum and adjuvant and the concentration of wetting agent, so definite best moulding process is A
2B
3C
3, i.e. the ratio 4: 1 of extractum and adjuvant, the wetting agent concentration of ethanol is 90%, consumption is 30%.
Through system experimentation research, confirm that the best preparation technology of the strong osseous granules of stilbene ginseng is: decoction pieces soaks 1h, extracts 3 times with 12 times of water yields, each 0.5h; Extracting solution is evaporated to relative density 1.05-1.10, and adding 95% ethanol is 50% to containing the alcohol amount, precipitate with ethanol 24h, and reclaiming ethanol to relative density of medicine liquid is 1.10; Heating medicinal liquid to 60 ℃ adds 2.5% dextrin, is that 160 ℃, 80 ℃ of air outlet temperature, charging rate are to carry out spray drying under the 40kg/h condition at intake air temperature; (dextrin: lactose=2: 1) be 4: 1 mixed, add 1% steviosin, be wetting agent with 90% ethanol to dried extract powder according to extractum and adjuvant; The wetting agent that adds adjuvant and extractum total amount 30% is processed soft material, crosses 10 mesh sieves and granulates 55 ℃ of oven dry; Granulate, packing promptly gets.
The strong bone granule of stilbene ginseng of the present invention preparation is tan granule, and feeble QI is fragrant, and it is sweet distinguish the flavor of, and little hardship has the effect of liver and kidney tonifying, benefiting QI for activating blood circulation, removing obstruction in the collateral to relieve pain, clinical treatment morning, the mid-term ischemia femur head necrosis that is used for.
Pharmacodynamic experiment is the result show: the strong bone granule of stilbene ginseng can make bone trabecula, osteocyte and medullary cavity structure, the form of femur head necrosis rat improve; Can reduce medullary cavity fat cell hypertrophy hypertrophy, outgrowth lesion degree; Can improve unusual hemorheology and dyslipidemia and increase state, improve bone density value, increase the intensity of osseous tissue, improve the biomechanical property of osseous tissue, corticosteroid femur head necrosis is had therapeutical effect preferably.Show that the strong osseous granules preparation technology of determined stilbene ginseng is reasonable, can extract the active ingredient of medicine more completely, guarantee drug effect.
(4) specific embodiments:
Below come further to set forth the present invention through embodiment, should be noted that these embodiment are merely the preferred example of the present invention in implementing, and do not constitute any restriction to the scope of the invention.
Embodiment 1:
Crude drug is formed: Radix Astragali 1100g, Radix Salviae Miltiorrhizae 1100g, Cortex Eucommiae 550g, Radix Angelicae Sinensis 1100g, Rhizoma Corydalis 1100, Semen Cuscutae 370g;
Method for preparing:
Differentiate (TLC) and HPLC content assaying method preferred feedstock medicine with thin layer, preferred raw medicinal material is soaked 1h, extract 3 times, each 0.5h with 12 times of water gaging amounts; It is 1.05～1.10 (temperature is reduced to and detected the relative density value under the room temperature condition, is generally 20-25 ℃, and is as follows) that extracting solution is evaporated to relative density; Add 95% ethanol and make that to contain alcohol amount be 50%; Precipitate with ethanol 24h reclaims ethanol to there not being the alcohol flavor, and to be evaporated to relative density of medicine liquid be 1.10; Heating medicinal liquid to 60 ℃ adds 2.5% dextrin, and 160 ℃ of intake air temperatures, 80 ℃ of air outlet temperature, charging rate are to carry out spray drying under the 40kg/h condition, obtain dry extract; According to dry extract and adjuvant (2: 1 mixed accessories of dextrin-lactose) is 4: 1 mixed, is wetting agent with 90% ethanol, and the wetting agent and 1% steviosin that add adjuvant and extractum total amount 30% are processed soft material; Crossing 10 mesh sieves granulates; 55 ℃ of oven dry, granulate, packing promptly gets the strong osseous granules of stilbene ginseng.
Embodiment 2:
Crude drug is formed: Radix Astragali 1000g, Radix Salviae Miltiorrhizae 1000g, Cortex Eucommiae 500g, Radix Angelicae Sinensis 1000g, Rhizoma Corydalis 1000g, Semen Cuscutae 350g;
Method for preparing: differentiate (TLC) and HPLC content assaying method preferred feedstock medicine with thin layer, preferred raw medicinal material is soaked 0.5h, extract 2 times, each 1h with 8 times of water gaging amounts; It is 1.05～1.10 that extracting solution is evaporated to relative density, adds 95% ethanol and makes that to contain alcohol amount be 60%, and precipitate with ethanol 6h reclaims ethanol to there not being the alcohol flavor, and to be evaporated to relative density of medicine liquid be 1.10; Heating medicinal liquid to 60 ℃ adds 2% dextrin, and 180 ℃ of intake air temperatures, 90 ℃ of air outlet temperature, charging rate are to carry out spray drying under the 40kg/h condition, obtain dry extract; It according to dry extract and adjuvant (2: 1 mixed accessories of dextrin-lactose) 1.5: 1 mixed; With 85% ethanol is wetting agent; The wetting agent and 2% steviosin that add adjuvant and extractum total amount 30% are processed soft material, cross 10 mesh sieves and granulate 55 ℃ of oven dry; Granulate, packing promptly get the strong osseous granules of stilbene ginseng.
Embodiment 3:
Crude drug is formed: Radix Astragali 1200g, Radix Salviae Miltiorrhizae 1200g, Cortex Eucommiae 600g, Radix Angelicae Sinensis 1200g, Rhizoma Corydalis 1200, Semen Cuscutae 400g;
Method for preparing: differentiate (TLC) and HPLC content assaying method preferred feedstock medicine with thin layer, preferred raw medicinal material is soaked 2h, extract 3 times, each 1h with 12 times of water gaging amounts; It is 1.05～1.10 that extracting solution is evaporated to relative density, adds 95% ethanol and makes that to contain alcohol amount be 50%, and precipitate with ethanol 12h reclaims ethanol to there not being the alcohol flavor, and to be evaporated to relative density of medicine liquid be 1.10; Heating medicinal liquid to 60 ℃ adds 3% dextrin, and 160 ℃ of intake air temperatures, 80 ℃ of air outlet temperature, charging rate are to carry out spray drying under the 40kg/h condition, obtain dry extract; According to dry extract and adjuvant (2: 1 mixed accessories of dextrin-lactose) is 3: 1 mixed, is wetting agent with 90% ethanol, and the wetting agent and 1% steviosin that add adjuvant and extractum total amount 30% are processed soft material; Crossing 10 mesh sieves granulates; 55 ℃ of oven dry, granulate, packing promptly gets the strong osseous granules of stilbene ginseng.
Claims (3)
1. Chinese medicine granules of treating femur head necrosis; Its crude drug consists of the Radix Astragali, Radix Salviae Miltiorrhizae, the Cortex Eucommiae, Radix Angelicae Sinensis, Rhizoma Corydalis, Semen Cuscutae; Each crude drug proportioning is: Radix Astragali 1000-1200, Radix Salviae Miltiorrhizae 1000-1200, Cortex Eucommiae 500-600, Radix Angelicae Sinensis 1000-1200, Rhizoma Corydalis 1000-1200, Semen Cuscutae 350-400, and each above-mentioned crude drug is weight ratio; Its preparation method: by proportioning crude drug is mixed, steeped 0.5-2 hour, extract 1-4 time, each 0.5-2 hour with 6-15 times of water logging; Filter, merging filtrate is evaporated to that relative density is 1.05～1.10 under the room temperature condition, adds 95% ethanol and makes and contain the alcohol amount and be 50-70%; Precipitate with ethanol 6-24h reclaims ethanol to there not being the alcohol flavor, and is evaporated to that relative density is 1.05～1.15 under the medicinal liquid room temperature condition, adds the 1-5% dextrin; Spray drying obtains dry extract, adds adjuvant, sieves, dries; Granulate, packing promptly gets Chinese medicine granules; Wherein adjuvant is dextrin, lactose, wetting agent and correctives; Dextrin: the lactose weight ratio is 2: 1, and the weight ratio that dry extract and dextrin add lactose is 4: 1-1: 1, and correctives is a steviosin; The consumption of correctives is the 1-2% of granule gross weight, and wetting agent is a 85-95% ethanol.
2. according to the Chinese medicine granules of the said treatment femur head necrosis of claim 1, it is characterized in that said each crude drug proportioning is: the Radix Astragali 1100, Radix Salviae Miltiorrhizae 1100, the Cortex Eucommiae 550, Radix Angelicae Sinensis 1100, Rhizoma Corydalis 1100, Semen Cuscutae 370, each above-mentioned crude drug is weight ratio.
3. the method for preparing of the Chinese medicine granules of treatment femur head necrosis according to claim 1 and 2 is characterized in that: each crude drug mixes, and adds 8-12 times of water gaging and soaks 1 hour, extracts each 0.5 hour 3 times; Filter, merging filtrate is evaporated to that relative density is 1.05～1.10 under the room temperature condition, adds 95% ethanol and makes that to contain the alcohol amount be 50%, and precipitate with ethanol 24h reclaims ethanol to there not being the alcohol flavor, and is evaporated to that relative density is 1.05～1.15 under the medicinal liquid room temperature condition; Heating medicinal liquid to 60 ℃ adding 2.5% dextrin, spray drying; The weight ratio that dried extract powder adds lactose according to extractum and dextrin is 4: 1 a mixed, adds 1% steviosin, is wetting agent with 85-90% ethanol; 30% the wetting agent that adds dextrin, lactose and extractum total amount is processed soft material, crosses the granulation of 10 mesh sieves, 55 ℃ of oven dry; Granulate, packing promptly gets.
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| CN104906374A (en) * | 2015-06-05 | 2015-09-16 | 鲍少华 | Traditional Chinese medicine for treating injury stasis type femoral head necrosis and preparing method |
| CN107375611B (en) * | 2017-08-18 | 2021-05-11 | 福建省中医药科学院 | Traditional Chinese medicine composition with breast enlargement effect and preparation method thereof |
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| CN1840057A (en) * | 2006-01-12 | 2006-10-04 | 李保明 | Medicine for treating femoral head necrosis and femur neck fracture and preparation method thereof |
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Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1840057A (en) * | 2006-01-12 | 2006-10-04 | 李保明 | Medicine for treating femoral head necrosis and femur neck fracture and preparation method thereof |
Non-Patent Citations (4)
| Title |
|---|
| 成立等.骨健口服液治疗股骨头缺血性坏死疗效观察-附136例病例报告.《中医正骨》.2008,第20卷(第5期),14-16. * |
| 杨凯.股骨头缺血性坏死中医药治疗进展.《辽宁中医药大学学报》.2007,第9卷(第2期),54-56. * |
| 章建华等.骨健制剂对激素性股骨头坏死血液流变学的影响.《中医正骨》.2008,第20卷(第4期),13-14. * |
| 章建华等.骨健口服液治疗激素性股骨头坏死60例临床报告.《浙江中医学院学报》.2005,第29卷(第4期),19-20. * |
Also Published As
| Publication number | Publication date |
|---|---|
| CN101843668A (en) | 2010-09-29 |
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