CN101088527B - Medicine composition for treating bone necrosis and its preparation process - Google Patents
Medicine composition for treating bone necrosis and its preparation process Download PDFInfo
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Abstract
The present invention relates to one kind of medicine composition for treating bone necrosis and its preparation process. The medicine composition is prepared with 12 kinds of Chinese medicinal materials, including notoginseng, drynaria, frankincense, aconite root, myrrh, etc in certain weight proportion. The medicine composition has the functions of reducing blood viscosity, decreasing clot lysistime, plasma clot dissolution time and euglobulin lysis time, promoting bone cell metabolism, etc, and can cure bone necrosis.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition that is used for the treatment of osteonecrosis and preparation method thereof.
Background technology
Head necrosis all might take place in any position of human body, and especially the highest with the femur head necrosis incidence rate, osteonecrosis occurs in the femoral head position, just is femur head necrosis.Doctor trained in Western medicine thinks that ischemic necrosis of femoral head is meant owing to different reasons make femoral head part or completeness ischemia take place, causes the pathological process of osteocyte, myeloid element and adipose cell necrosis.Because body has natural repair ability to the necrotic area, when the area of new bone cell with new vessels to the necrotic area growth and when forming new bone, the necrotic bone girder will progressively be absorbed.The mechanical property of bone obviously weakens in this process, and normal heavy burden can cause the collapse of the femoral head distortion.Clinical symptoms based on pain and moving obstacle appears in the patient.The traditional Chinese medical science is then thought the necrosis of femur head aseptic (ischemia) property, and its etiology and pathogenesis is mainly caused by liver and kidney deficiency, and QI and blood is retarded by silt, and bone loses and moistens and fall ill.Or hindered or for the evil poison of six climate exopathogens, QI-blood circulation is obstructed by violence, blood stasis is stagnated, and femoral head loses to moisten in QI and blood and supports and downright bad; If seven emotions overwork or impairment caused by overstrain are excessive, essence and blood is secretly consumed, insufficiency of vital energy and blood, femoral head lose in moistening foster falls ill.The natural endowment deficiency is more arranged, caused by liver and kidney deficiency, the femoral head dysplasia then meets pessimal stimulation and is easier to necrosis.In a word, the pathogenesis of osteomyelitis has the difference of specimen, is deficiency of the liver and kindey at this, and muscles and bones mistake is supported; Be designated as stagnation of blood stasis, the femoral head blood supply insufficiency, and send out sick for this reason.
Develop a kind of effectively aspect Repercusion analgesia, the activating-bone medicine thing that can improve patient's clinical symptoms just becomes the problem that those skilled in the art face.
Summary of the invention
It is a kind of effective aspect Repercusion analgesia that one of purpose of the present invention is to provide, and can improve the pharmaceutical composition that is used for the treatment of osteonecrosis of patient's clinical symptoms point.
Another object of the present invention provides a kind of manufacturing method for above mentioned medicine.
The objective of the invention is to reach by the following technical programs:
A kind of pharmaceutical composition that is used for the treatment of osteonecrosis is characterized in that it is mainly made by the crude drug of following weight composition: Radix Notoginseng 4-8 part, Rhizoma Drynariae 5-8 part, Olibanum 3-6 part, Radix Aconiti 4-16 part, Myrrha 3-6 part, Radix Salviae Miltiorrhizae 5-8 part, Radix Angelicae Sinensis 5-8 part, Rhizoma Chuanxiong 4-8 part, Radix Aconiti Kusnezoffii 4-8 part, Scorpio 3-4 part, Eupolyphaga Seu Steleophaga 5-8 part, Periostracum Serpentis 2-6 part.
A kind of optimal technical scheme is characterized in that: Radix Notoginseng 6 parts of (weight, down together), 6 parts of Rhizoma Drynariae, 4 parts of Olibanums, 10 parts of Radix Aconiti, 4 parts of Myrrhas, 6 parts of Radix Salviae Miltiorrhizaes, 6 parts of Radix Angelicae Sinensis, 6 parts of Rhizoma Chuanxiongs, 6 parts of Radix Aconiti Kusnezoffii, 3 parts of Scorpios, 6 parts of Eupolyphaga Seu Steleophagas, 4 parts of Periostracum Serpentiss.
A kind of optimal technical scheme is characterized in that: its crude drug also comprises vegetable oil 350-370 part, Plumbum preparatium 110-160 part.
A kind of optimal technical scheme is characterized in that: its crude drug also comprises 360 parts of vegetable oil, 135 parts of Plumbum preparatium.
A kind of preparation of drug combination method that is used for the treatment of osteonecrosis, its step is as follows:
(1) get Radix Notoginseng, Scorpio, Olibanum, Myrrha in proportion and be ground into fine powder, sieve, mixing, fine powder;
(2) get Rhizoma Drynariae, Radix Aconiti, Radix Salviae Miltiorrhizae, Radix Angelicae Sinensis, Rhizoma Chuanxiong, Radix Aconiti Kusnezoffii, Eupolyphaga Seu Steleophaga, Periostracum Serpentis in proportion and give as one thinks fit cataclasmly, get vegetable oil in proportion, with putting in the pot, under 200-220 ℃, fried withered, remove slag, filter, to dripping into pearl, get medicine oil 320-220 ℃ of following refining;
(3) get Plumbum preparatium in proportion, add in step (2) the gained medicine oil, stir evenly, receive cream, cream is soaked in the water;
(4) get step (3) gained cream, dissolve with slow fire, step (1) gained fine powder is added wherein, stir evenly, share on cloth, plaster gets product.
Radix Notoginseng in the medicine of the present invention, property is hidden sweet little bitter tepor, GUIXIN liver spleen channel, removing stasis to stop bleeding, reducing swelling and alleviating pain is the traumatology key medicine, hemostasis is arranged and does not keep on file, changes silt and do not hinder positive characteristics, so be monarch drug.Rhizoma Drynariae, Olibanum, Myrrha, Radix Angelicae Sinensis, Radix Salviae Miltiorrhizae, Rhizoma Chuanxiong are ministerial drug.Rhizoma Drynariae, property are hidden bitter temperature, return the Liver and kidney warp.The temperature compensation Liver and kidney, bone and muscle strengthening again can the promoting the circulation of blood arteries and veins, reuniting the fractured tendons and bones, the pain relieving of curing the wound.This medicine has the effect of the kidney invigorating bone strengthening among the pain relieving concurrently invigorating blood circulation to cure the wound, because of can the set a broken bone fragmentation, so with the Rhizoma Drynariae name it." Kaibao Bencao " calls it, and " benefit is traumaticd fracture for main removing blood stasis, hemostasis." Olibanum, the arduous temperature of nature and flavor, GUIXIN liver spleen channel.Has the blood-activating and qi-promoting pain relieving, the detumescence and promoting granulation effect.The hot temperature of loosing of this product is logical can invigorating blood circulation paralysis, and promoting the circulation of QI to relieve pain are used for various pain diseases more, again can the promoting blood circulation and detumescence pain relieving, and removing the necrotic tissue and promoting granulation.Myrrha, nature and flavor are bitter flat, GUIXIN liver spleen channel.Promoting blood circulation and stopping pain is arranged, the detumescence and promoting granulation effect.With the Olibanum mutual reinforcement between is hold back skin ulcer, promoting blood circulation and stopping pain with the energy detumescence and promoting granulation.Radix Angelicae Sinensis, property is hidden sweet temperature, and the GUIXIN Liver Channel is the key medicine of enriching blood.This product can be enriched blood and can be invigorated blood circulation, and can dispersing cold for relieving pain, thus clinical be best suited for the passages through which vital energy circulates of blood deficiency due to being retarded by silt lose foster, bones and muscles pain.Radix Salviae Miltiorrhizae, property are hidden hardship and are slightly cold, the GUIXIN Liver Channel, and merit is arrogated to oneself activating blood circulation to dissipate blood stasis, and property is more gentle, can method trace tissue regeneration promoting and just do not hinder.Rhizoma Chuanxiong, property and flavor of peppery and warm is returned liver and gall pericardium channel, and the hot temperature of loosing of this product is logical, can invigorate blood circulation, again can circulation of qi promoting, be gas medicine in the blood.So can treat the various pain due to the stagnation of QI blood stain.More than six health preserving with drugs blood invigorate blood circulation, disperse blood stasis and dredge collateral, reducing swelling and alleviating pain is so be ministerial drug altogether.Eupolyphaga Seu Steleophaga, Scorpio, Radix Aconiti, Radix Aconiti Kusnezoffii, Periostracum Serpentis are adjuvant drug in the side.Eupolyphaga Seu Steleophaga, nature and flavor are salty-cold, return Liver Channel, and merit is arrogated to oneself removing blood stasis by trace, reunion of fractured tendons and bones, the pain relieving of curing the wound.Scorpio, nature and flavor are salty flat, return Liver Channel, resolving mass and removing the obstruction of the collateral, pain relieving relieving convulsion.Radix Aconiti, Radix Aconiti Kusnezoffii, the arduous temperature of nature and flavor, GUIXIN liver spleen kidney channel, timid wind and relieving paralysis, antalgic.Eupolyphaga Seu Steleophaga, Scorpio, Radix Aconiti, the shared blood circulation and removing stasis of Radix Aconiti Kusnezoffii, antalgic has stronger analgesic effect, and Periostracum Serpentis is hidden salty sweet flat, returns Liver Channel.Have timid wind arresting convulsion, detoxifcation, so nebula removing is adjuvant drug.Edible vegetable oil, Plumbum preparatium are messenger drug.Plumbum preparatium, the property suffering is slightly cold, the GUIXIN Liver Channel, externally applied toxicity removing and granulation promoting, killing parasites for relieving itching is messenger drug.Full side's compatibility activating blood circulation to dissipate blood stasis, relaxing muscles and tendons and activating QI and blood in the collateral, reducing swelling and alleviating pain are used for the treatment of arthroncus, pain, movable unfavorable, and femur head necrosis, osteoarthritis, hyperosteogeny, the traumatic injury person that sees the above-mentioned symptom.
Medicine of the present invention causes rat femur head necrosis to the life-time service prednisolone acetate the good curing effect.For the heavy dose of treatment of the sick hormone of SARS causes that the treatment of intercurrent disease femur head necrosis provides test basis.Experiment shows that the present invention can obviously increase femoral bmd BMD, BMC content, can increase rat femur weight in wet base, dry weight, ash amount apparent in viewly and strengthen rat femur bone strength and bone rigidity.The microcirculation result shows on the femoral head periosteum observing under the microscopic examination system, medicine of the present invention can make the approaching recovery of blood capillary normal level distribution in the animal femoral head, arrange also more regularly, medicine of the present invention can make chondrocyte fat tinctorial yield and osteocyte fat tinctorial yield obviously reduce.Can reduce serum estradiol content again in addition.In addition, pharmacodynamics shows that medicine of the present invention also has the osteoporotic effect of control except that the above symptom of treatment.
As everyone knows, the blood viscosity increase is a blood fortune obstacle major reason.Medicine of the present invention obviously reduces plasma viscosity, shortens the result of the test of whole blood blood-clot lysis time, whole plasm EGCT and euglobulin lysis time, can also overcome femur head necrosis blood fortune obstacle.Loose blood capillary is recovered, and increases femur head necrosis regional flow's speed and blood flow, promotes that the generation of necrotic bone cellular metabolism and new osteocyte may be one of this medicine mechanism of action.
The present invention contains Scorpio and Eupolyphaga Seu Steleophaga, and this two flavor is an adjuvant drug in the present invention, has the pain relieving relieving convulsion, the effect of resolving mass and removing the obstruction of the collateral.
Scorpio
1. the twin tic of fullying recover from an illness.This product master goes into Liver Channel, and property is apt to away scurry, and both calms down, liver-wind, and expel wind to dredge collateral again has the effect of good endogenous wind stopping relieving convulsion, for controlling the twin key medicine of hitting of taking out of layer, this symptom is just arranged in the femur head necrosis clinical manifestation.
2. rheumatoid arthritis stubborn.This product is good at removing obstruction in the collateral to relieve pain, and to the anemofrigid-damp arthralgia obstinate, the muscle arteries and veins is arrested twin, and very then the insensitive impediment of joint deformity acts on rather good.So clinical also normal with invigorate blood circulation, the product of timid wind, relaxing muscles and tendons and activating QI and blood in the collateral are with using.
3. the important symptom of femur head necrosis is a pain, and Scorpio has good analgesic effect, and patient's states is improved.
Be analyzed as follows from existing chemical medicine pharmacological research:
Contain scorpion venom in the Scorpio, be that a kind of albumen kind is more but mixture that the pheron kind is less, scorpion venom mainly is made up of nonprotein and protein two parts, mainly contains lipid, organic acid, free amino acid etc. in non-albumen is formed.
1, analgesic activity.Measure with conventional heat radiation tail-flick method of rat and mice and acetic acid twisting method and to take off body and the analgesic activity of taking off tail, the result shows: no matter scorpion body and scorpion tail isosmotic solution are irritated stomach or quiet notes, animal body pain or Encelialgia are all had obvious analgesic activity.The mouse writhing experiment shows that the analgesic activity of charybdotoxin III (the many skins of analgesic activities) is also strong than the antondin effect.
2, to the effect of blood system.Scorpion extraction liquid can obviously alleviate the rat vein thrombus weight, and its thrombosis suppression ratio is 21.73%; Make the activation partial thromboplastin time simultaneously, activated partial thromboplastin time all obviously prolongs, and Antithrombin III activity and content of plasminogen obviously reduce.
Eupolyphaga Seu Steleophaga: removing blood stasis, reunion of fractured tendons and bones is traumatology medicine commonly used, to the congestion good curative effect that swollen and ache, cooperates monarch-minister drug that the blood stasis of patient's affected part is removed, vim and vigour are unimpeded.According to document, has antithrombotic pharmacological action.As above discuss, Eupolyphaga Seu Steleophaga can cooperate with Scorpio, prolongs clotting time, microcirculation improvement.
The specific embodiment
The present invention will be further described below by the specific embodiment, but and do not mean that qualification to protection domain of the present invention.
Embodiment 1
A kind of preparation of drug combination method that is used for the treatment of osteonecrosis, its step is as follows:
(1) Radix Notoginseng 600 grams, Scorpio 300 grams, Olibanum 400 grams, Myrrha 400 grams are ground into fine powder, sieve, and mixing gets 120 order fine powders;
(2) Rhizoma Drynariae 600 grams, Radix Aconiti 1000 grams, Radix Salviae Miltiorrhizae 600 grams, Radix Angelicae Sinensis 600 grams, Rhizoma Chuanxiong 600 grams, Radix Aconiti Kusnezoffii 600 grams, Eupolyphaga Seu Steleophaga 600 grams, Periostracum Serpentis 400 grams are given as one thinks fit cataclasm; Get 13.5 kilograms of vegetable oil in proportion, remove slag, slight fever gets medicinal plant oil, with putting in the pot, mixes, soaks 1 hour; Under 200-220 ℃, fried withered, remove slag, filter, to dripping into pearl, get medicine oil 320-220 ℃ of following refining;
(3) get 36 kilograms of Plumbum preparatium (lead orthoplumbate) in proportion, add in step (2) the gained medicine oil, stir evenly, receive cream, cream is soaked in the water;
(4) get step (3) gained cream, dissolve with slow fire, step (1) gained fine powder is added wherein, stir evenly, share on cloth, plaster 1 gets product.
Embodiment 2
A kind of preparation of drug combination method that is used for the treatment of osteonecrosis, its step is as follows:
(1) Radix Notoginseng 400 grams, Scorpio 400 grams, Olibanum 600 grams, Myrrha 600 grams are ground into fine powder, sieve, and mixing gets 120 order fine powders;
(2) Rhizoma Drynariae 800 grams, Radix Aconiti 1600 grams, Radix Salviae Miltiorrhizae 800 grams, Radix Angelicae Sinensis 800 grams, Rhizoma Chuanxiong 800 grams, Radix Aconiti Kusnezoffii 800 grams, Eupolyphaga Seu Steleophaga 800 grams, Periostracum Serpentis 600 grams are given as one thinks fit cataclasm; Get 37 kilograms of vegetable oil in proportion, remove slag, slight fever gets medicinal plant oil, with putting in the pot, mixes, soaks 1 hour; Under 200-220 ℃, fried withered, remove slag, filter, to dripping into pearl, get medicine oil 320-220 ℃ of following refining;
(3) get 16 kilograms of Plumbum preparatium (lead orthoplumbate) in proportion, add in step (2) the gained medicine oil, stir evenly, receive cream, cream is soaked in the water;
(4) get step (3) gained cream, dissolve with slow fire, step (1) gained fine powder is added wherein, stir evenly, share on cloth, plaster 2 gets product.
Embodiment 3
A kind of preparation of drug combination method that is used for the treatment of osteonecrosis, its step is as follows:
(1) Radix Notoginseng 800 grams, Scorpio 300 grams, Olibanum 300 grams, Myrrha 300 grams are ground into fine powder, sieve, and mixing gets 120 order fine powders;
(2) Rhizoma Drynariae 500 grams, Radix Aconiti 400 grams, Radix Salviae Miltiorrhizae 500 grams, Radix Angelicae Sinensis 500 grams, Rhizoma Chuanxiong 400 grams, Radix Aconiti Kusnezoffii 400 grams, Eupolyphaga Seu Steleophaga 500 grams, Periostracum Serpentis 200 grams are given as one thinks fit cataclasm; Get 11 kilograms of vegetable oil, remove slag, slight fever gets medicinal plant oil, with putting in the pot, mixes, soaks 1 hour; Under 200-220 ℃, fried withered, remove slag, filter, to dripping into pearl, get medicine oil 320-220 ℃ of following refining;
(3) get 35 kilograms of Plumbum preparatium (lead orthoplumbate) in proportion, add in step (2) the gained medicine oil, stir evenly, receive cream, cream is soaked in the water;
(4) get step (3) gained cream, dissolve with slow fire, step (1) gained fine powder is added wherein, stir evenly, share on cloth, plaster 3 gets product.
Clinical trial:
1. physical data
1.1 patient's physical data
Patient's 60 examples, wherein male 32 examples, women 28 examples, age 15-68 year, average 43.2 years old, the course of disease 1 month-36 months, average 23 months, pathogenesis: traumatic 12 examples, atraumatic 48 examples (wherein hormonal 34 examples, rheumatoid 9 examples, ethanol 4 examples, unknown cause 1 example)
1.2 severe extent
Standard Ficat is by stages by stages by internationally recognized femur head necrosis:
I phases 13 example, II phases 25 example, III phases 14 example, IV phases 8 example.
2. diagnostic criteria and curative effect judging standard
2.1 diagnostic criteria adopts internationally recognized Ficat to reach diagnostic criteria by stages, promptly hip pain, limitation of activity and dysfunction are three big clinical manifestations of femur head necrosis, add the FicatX line by stages.
2.2 curative effect judging standard: according to China Academy of TCM, the standard that the Jiang Weizhuan professor is formulated, i.e. following table:
Table 1-1 aseptic necrosis of femoral head clinical disease mutual affection level and curative effect determinate standard
Annotate: hip joint range of movement normal value:
Anteflexion 130 degree-140 degree, after stretch 10 degree-15 degree, abduction 30 degree-45 degree, interior receipts 20 degree-30 degree, thirty degree turn out-40 degree, inward turning 40 degree-50 degree, summation 260 degree-320 degree
Table 1-2 state of an illness weight is judged (score value according to above-mentioned symptom and sign is comprehensively fixed)
3. Therapeutic Method
Getting 1 on the heavy plaster of the medicine net weight 45g of the embodiment of the invention 1 preparation is heated to about 50 ℃ through warm fire, evenly the back is cool to about 40 ℃ to treat its fusing, with the HUANTIAO acupoint is outside the center is affixed on behind the hip joint, take the evenly back subsides usefulness continuously of heating every day off, used subsides in 7 days instead, subsides were a course of treatment with 3 months continuously, and all cases are with expiring 2 courses of treatment.
4. therapeutic outcome
4.1 to traumatic aseptic necrosis of femoral head:
4.2 to the atraumatic femur head necrosis
5. untoward reaction and control
In whole 60 routine patient's medication processes, local pruritus appears in 1 example, does not have obvious redness and General Symptoms, transference cure after drug withdrawal is had a rest; Local skin erythema and pruritus gradually appear in 1 routine medication in the time of 3 days, through in clothes chlorphenamine and outside be coated with fluocinonide ointment after 3 days, transference cure, adverse reaction rate are 3.33%.
6. evaluation of clinical curative effect
Through selecting 60 examples to suffer from the aseptic necrosis of femoral head patient at random, all through the external bone-activating ointment treatment of 2 courses of treatment, total effective rate is 96.67%, acceptance rate is 88.33%, adverse reaction rate is 3.33%, and untoward reaction is local Pruritus and erythema, but after drug withdrawal and fluocinonide external transference cure.So Clinical Practice checking, medicine of the present invention are the Chinese medicine for external application with significant curative effect of a treatment aseptic necrosis of femoral head.
Claims (3)
1. pharmaceutical composition that is used for the treatment of osteonecrosis is characterized in that it is made by the crude drug of following weight composition: Radix Notoginseng 4-8 part, Rhizoma Drynariae 5-8 part, Olibanum 3-6 part, Radix Aconiti 4-16 part, Myrrha 3-6 part, Radix Salviae Miltiorrhizae 5-8 part, Radix Angelicae Sinensis 5-8 part, Rhizoma Chuanxiong 4-8 part, Radix Aconiti Kusnezoffii 4-8 part, Scorpio 3-4 part, Eupolyphaga Seu Steleophaga 5-8 part, Periostracum Serpentis 2-6 part, vegetable oil 350-370 part, Plumbum preparatium 110-160 part.
2. the pharmaceutical composition that is used for the treatment of osteonecrosis according to claim 1 is characterized in that: 6 parts of Radix Notoginseng, 6 parts of Rhizoma Drynariae, 4 parts of Olibanums, 10 parts of Radix Aconiti, 4 parts of Myrrhas, 6 parts of Radix Salviae Miltiorrhizaes, 6 parts of Radix Angelicae Sinensis, 6 parts of Rhizoma Chuanxiongs, 6 parts of Radix Aconiti Kusnezoffii, 3 parts of Scorpios, 6 parts of Eupolyphaga Seu Steleophagas, 4 parts of Periostracum Serpentiss, 360 parts of vegetable oil, 135 parts of Plumbum preparatium.
3. described preparation of drug combination method that is used for the treatment of osteonecrosis of claim 1, its step is as follows:
(1) get Radix Notoginseng, Scorpio, Olibanum, Myrrha in proportion and be ground into fine powder, sieve, mixing, fine powder;
(2) get Rhizoma Drynariae, Radix Aconiti, Radix Salviae Miltiorrhizae, Radix Angelicae Sinensis, Rhizoma Chuanxiong, Radix Aconiti Kusnezoffii, Eupolyphaga Seu Steleophaga, Periostracum Serpentis in proportion and give as one thinks fit cataclasmly, get vegetable oil in proportion, with putting in the pot, under 200-220 ℃, fried withered, remove slag, filter, to dripping into pearl, get medicine oil 320-220 ℃ of following refining;
(3) get Plumbum preparatium in proportion, add in step (2) the gained medicine oil, stir evenly, receive cream, cream is soaked in the water:
(4) get step (3) gained cream, dissolve with slow fire, step (1) gained fine powder is added wherein, stir evenly, share on cloth, plaster gets product.
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| CN101088527B true CN101088527B (en) | 2010-05-12 |
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| CN102716251B (en) * | 2011-06-20 | 2014-10-08 | 王长锋 | Externally dressed drug for treating femoral head necrosis |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1389252A (en) * | 2002-07-24 | 2003-01-08 | 李如元 | Composite medicine for treating femoral head necrosis |
| CN1686195A (en) * | 2005-04-30 | 2005-10-26 | 汪景发 | Traditional Chinese medicine for treating femur necrosis |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1389252A (en) * | 2002-07-24 | 2003-01-08 | 李如元 | Composite medicine for treating femoral head necrosis |
| CN1686195A (en) * | 2005-04-30 | 2005-10-26 | 汪景发 | Traditional Chinese medicine for treating femur necrosis |
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