CN100335079C - Oral Chinese medicine preparation of caput femoris ischemic necrosis and production thereof - Google Patents
Oral Chinese medicine preparation of caput femoris ischemic necrosis and production thereof Download PDFInfo
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Abstract
The present invention belongs to a Chinese patent medicine, more specifically an oral Chinese medicine preparation for treating ischemic necrosis of a femoral head and a preparing process of an oral Chinese medicine preparation for treating ischemic necrosis of a femoral head. The preparation can be capsules, tablets or powder. The capsules are proportionally prepared by mixing Chinese angelica roots, red sage roots, astragalus roots, corydalis tuber, safflower, frankincense and myrrh which are evenly mixed with moschus through processes, such as drying, pulverization, mixing, etc. The oral Chinese medicine preparation for treating ischemic necrosis of a femoral head is proved by pharmacodynamics researches, large amounts of clinical tests and cases to have the efficacy of vital energy invigoration, blood nourishment, blood circulation promotion, bone blood supply improvement, meridian dredging, clot expelling, tissue regeneration promotion, and new bone formation acceleration.
Description
Technical field
The invention belongs to the Chinese patent medicine invention, be specifically related to a kind of oral preparation of Chinese traditional medicinal and preparation technology thereof who treats ischemic necrosis of femoral head.
Technical background
Ischemic necrosis of femoral head is meant because the different causes of disease causes capital disturbance of blood circulation, makes femoral head that the pathological process of part or completeness ischemia take place.Mainly show as symptoms such as the hip arthralgia, function limitation, lower limb muscles atrophy.Be a kind of commonly encountered diseases that has a strong impact on limb function, its course of disease is long, the disability rate height.For its main pathogeny, the intravascular coagulation theory more and more obtains the approval of Chinese scholars in recent years.Chinese medicine thinks that its disease belongs to " osteomyelitis " category, many because insufficiency of vital energy and blood, wound, long-term excessive consumption of alcohol, hormone abuse, rheumatism or sclerotin dysplasia etc. cause local stagnation of QI-blood, venation is obstructed, make it lose QI and blood and nourish, finally cause ischemic necrosis of femoral head.Still inefficacy is definite and obtain internationally recognized treatment means at present.This sick Therapeutic Method often is divided into operative treatment and non-operative treatment both at home and abroad.Non-operative treatment is electrostimulation, hyperbaric oxygentherapy etc., though its method can alleviate some pain and there is certain curative effect the walking aspect, can not solve root problem, and long-term effect is difficult to estimate.Though operative treatment has certain effect, the expense height, painful big, post-operative recovery is slow, and tends to occur collapse of the femoral head, and situations such as the loosening dislocation of artificial thigh bone are for the patient brings bigger misery.
Summary of the invention
In view of above-mentioned existing problem, the object of the present invention is to provide a kind of ischemic necrosis of femoral head treatment that is applicable to, can effectively promote its local blood circulation, improve the flesh and blood supply, the meridian dredging relaxes, blood stasis dispersing and fresh blood promoting, quicken newly osteogenetic, determined curative effect and oral preparation of Chinese traditional medicinal easy to use, reasonable price.
The invention belongs to the oral Chinese medicine preparation that is used for the treatment of ischemic necrosis of femoral head, it is the medicine that the Chinese herbal medicine by the following weight ratio is prepared from, wherein Radix Angelicae Sinensis 10 ~ 30%, Radix Salviae Miltiorrhizae 10 ~ 30%, the Radix Astragali 20 ~ 50%, Rhizoma Corydalis 5 ~ 15%, Flos Carthami 5 ~ 15%, Olibanum 5 ~ 15%, Myrrha 5 ~ 15%, Moschus 0.1 ~ 0.3%.
The preparation technology of the oral Chinese medicine preparation of specially for treating caput femoris ischemic necrosis among the present invention comprises following technical process:
The first step: Radix Angelicae Sinensis, Radix Salviae Miltiorrhizae, the Radix Astragali, Rhizoma Corydalis, Flos Carthami, Olibanum, Myrrha were measured clean pharmaceutical decocting piece by proportioning in will writing out a prescription, in 60～80 ℃ of dryings 4～5 hours;
Second step: the medical material that above-mentioned drying is good adopts medicinal pulverizer, uses and mixes comminuting method, pulverizes the back and crosses 100 mesh sieves, gets the fine powder mixing, and is standby;
The 3rd step: other gets Moschus and gets all the ready by proportional quantity, adopts bottoming chromatography and equivalent incremental method and above-mentioned standby fine powder cover to grind mixing;
The 4th step: the material of above-mentioned mixing is made capsule, tablet or powder, promptly.
The Radix Astragali can invigorate vital energy and yang in this prescription, promotes the blood vessels operation, can strengthen physical ability again; Chinese angelica blood supplementing, invigorate blood circulation, strengthen the merit of blood circulation promoting and blood stasis dispelling with Radix Salviae Miltiorrhizae, Flos Carthami compatibility; The pain relieving of Rhizoma Corydalis regulating qi to disperse stagnation, same Olibanum, Myrrha use plays promoting blood circulation and stopping pain, the effect of detumescence and promoting granulation altogether; Moschus acrid in the mouth, warm in nature, fragrance are walked to scurry, current 12 warps, the collateral dredging of having one's ideas straightened out, blood circulation promoting and blood stasis dispelling, the bone growth promoting of subsiding a swelling again.All medicines share, and make qi and blood tonifying, promote local blood circulation, improve the flesh and blood supply, the meridian dredging that relaxes, and blood stasis dispersing and fresh blood promoting quickens the generation of new bone, reaches the purpose for the treatment of both the principal and secondary aspects of a disease.
The present invention has carried out zoopery pharmacodynamic study and clinical application research.36 of adult healthy rabbit are adopted in zoopery, adopt the liquid nitrogen freezing method to prepare the animal model of rabbit bilateral femoral head ischemic necrosis, be divided into experimental group and matched group at random, postoperative is all fed with normal diet, and experimental group is irritated the suspension that the oral preparation of Chinese traditional medicinal of treatment ischemic necrosis of femoral head of the present invention is made simultaneously.Respectively at postoperative 6,12 and 20 weeks putting to death rabbit, observe every experimental index.The result shows, experimental group serum AKP level ase (seeing Table 1), bone density (seeing Table 2) all obviously raise than matched group, it is a certain than commitment termination and appearance reparation sign in it that femoral head general form, light microscopic and X-ray film demonstrate the experimental group osteonecrosis, and organizational structure is observed and shown that experimental group femoral head organizational structure is than the fine and close rule of matched group.Experimental group postoperative the 6th all histopathology are observed a large amount of cell compositions between visible necrotic bone girder, simultaneously, a large amount of new vessels and initial stage bone trabecula appear in the position far away slightly in the distance necrotic area, the 12 all experimental grouies show that the cell composition reduces to some extent between bone trabecula, abundant new vessels is arranged, bone trabecula density has increase, and the 20 week was taken the photograph sheet, and the experimental group bone trabecula distributes gradually even.This abundant new vessels and a large amount of fibroblast, chondrocyte and osteoblast all help the acceleration that necrotic bone is rebuild.
Table 1 liang treated animal blood AKP specific activity is the ((unit: Jin Shi u/L) of sample mean ± s)
| Group | 6 weeks | 12 weeks | 20 weeks |
| The experimental group matched group | 104.9±28.1 96.5±27.9 | 136.6±18.9* 102.4±19.7 | 130.7±28.7* 96.1±7.6 |
Annotate: experimental group and concurrent control group compare, * P＜0.05.
Table 2 liang group laboratory animal postoperative 20 all femoral head bone densities are (g/cm relatively
3)
| Group | Before the modeling | 20 weeks of postoperative |
| The experimental group matched group | 0.858±0.132 0.856±0.127 | 0.871±0.145* 0.846±0.221 |
Annotate: experimental group and concurrent control group compare, * P＜0.05.
The present invention simultaneously also proves through a large amount of clinical practices.The ischemic necrosis of femoral head patient of 275 customary vascular pedicle bone transpositions of flap is divided into 2 groups at random, experimental group 153 examples, postoperative is taken the oral preparation of Chinese traditional medicinal of treatment femur head necrosis of the present invention, matched group 122 routine postoperatives are taken calcium preparation and vitamin D3, observe postoperative swell and ache (table 3), alkali phosphatase (ALP) active (table 4) respectively, bone density (table 5) and Radiologic imaging.The result shows the present invention's alleviating pain rapidly, strengthens the ALP activity, and patient's bone density is increased.Iconography observation experiment group bone healing time obviously shortens.
Table 3 operation side hip pain relieving time (my god) (n=275)
| Group | Produce effects | Effectively | Pain relieving fully | Inefficiency % |
| Test group | 1.3±0.8 | 3.1±1.6 | 9.1±2.9 | 6.2 |
| Matched group | 6.3±2.4 | 14.5±3.9 | 18.3±4.2 | 26.4 |
Table 4 alkaline phosphatase assay (ALP) unit: u/L
| Group | Before the observation # | 2 week back * |
| Test group | 17.9±5.3 | 43.6±16.9 |
| Matched group | 18.1±4.9 | 31.9±15.7 |
Annotate:
#P＞0.05 * P＜0.05
Table 5 bone density changes (BMC/BW)
| Group | Before the observation | * after three months |
| Test group | 0.682±0.134 | 0.698±0.121 |
| Matched group | 0.684±0.127 | 0.669±0.196 |
Annotate: * P＜0.05
Pharmacodynamic study and clinical trial confirm that all the present invention can improve local blood circulation, quicken new osteogenesis, are the active drugs of treatment ischemic necrosis of femoral head.
The specific embodiment
Embodiment one: as if 300 of the oral Chinese medicine capsules for preparing the specially for treating caput femoris ischemic necrosis, the weight of each medicine in its prescription is composed as follows:
Radix Angelicae Sinensis 13.5g Radix Salviae Miltiorrhizae 18g Radix Astragali 22.5g Rhizoma Corydalis 9g Flos Carthami 7.2g
Olibanum 8.64g Myrrha 10.98g Moschus 0.18g
The preparation technology of the oral Chinese medicine preparation of treatment ischemic necrosis of femoral head of the present invention is as follows:
The first step: Radix Angelicae Sinensis, Radix Salviae Miltiorrhizae, the Radix Astragali, Rhizoma Corydalis, Flos Carthami, Olibanum, Myrrha were measured clean pharmaceutical decocting piece by proportioning in will writing out a prescription, in 75 ℃ of dryings 4 hours;
Second step: the medical material that above-mentioned drying is good adopts medicinal pulverizer, uses and mixes comminuting method, pulverizes the back and crosses 100 mesh sieves, gets the fine powder mixing, and is standby;
The 3rd step: other gets Moschus and gets all the ready by proportional quantity, adopts bottoming chromatography and equivalent incremental method and above-mentioned standby fine powder cover to grind mixing;
The 4th step: with the medicated powder of above-mentioned mixing with medicinal capsule machine encapsulated (0.3g/ grain), promptly.
Embodiment two: as if 300 in the oral Chinese medicine tablet for preparing the specially for treating caput femoris ischemic necrosis, the weight of each medicine in its prescription is composed as follows:
Radix Angelicae Sinensis 10g Radix Salviae Miltiorrhizae 12g Radix Astragali 34.87g Rhizoma Corydalis 7.72g Flos Carthami 8g
Olibanum 7.28g Myrrha 10g Moschus 0.13g
The preparation technology of the oral Chinese medicine preparation of treatment ischemic necrosis of femoral head of the present invention is as follows:
First ~ the 3rd step is with embodiment one;
The 4th step: the medicated powder of above-mentioned mixing is pressed into the tablet of 0.3g/ sheet, promptly.
Embodiment three: if the oral Chinese medicine powder 300g of preparation specially for treating caput femoris ischemic necrosis, the weight of each medicine in its prescription is composed as follows:
Radix Angelicae Sinensis 19.5g Radix Salviae Miltiorrhizae 10.5g Radix Astragali 33.5g Rhizoma Corydalis 5.6g Flos Carthami 8.15g
Olibanum 6g Myrrha 6.5g Moschus 0.25g
The preparation technology of the oral Chinese medicine preparation of treatment ischemic necrosis of femoral head of the present invention is as follows:
First ~ the 3rd step is with embodiment one;
The 4th step: the medicated powder of above-mentioned mixing is distributed into the powder of 3g/ bag, promptly.
Efficacy analysis of the present invention is as follows:
Case one, Lee * *, the man, 38 years old, the cook, do not have obvious inducement and right hip pain 1 year occurs, once reached symptomatic treatments such as " hip myofascitis " parallel physical therapy and relaxing muscles and tendons to promote blood circulation in outer court's diagnosis " rheumatism ", symptom does not slow and separates, sx the first half of being admitted to hospital, the right side occurring walks lamely, CT and the MRI inspection of going once more turns out to be " right side ischemic necrosis of femoral head ", successively tosses about in bed in the man hospital admission of domestic number, gives various homemade traditional Chinese drug preparation orals treatments, the commentaries on classics of not getting better yet, outer court's suggestion pedestrian worker total hip replacement, it refuses to accept, and changes my institute then over to and seeks medical advice.AD " right side ischemic necrosis of femoral head; III phase ", the Harris scoring is 47 minutes before the art, after being admitted to hospital promptly with 5 of the Chinese medicinal capsule agent of treatment ischemic necrosis of femoral head of the present invention, days three times oral, right lower extremity continues to prepare before the skin traction art, drug withdrawal after ten days (first three day of art), be admitted to hospital two weeks of back, on August 5th, 1998 is in continuous epidural anesthesia descending " right side ischemic necrosis of femoral head focal cleaning, band revolve thigh lateral blood vessel ascending branch ilium lobe and shift prothesis ", row bottom right primary minimum heavy weight hide traction braking, postoperative three days recovers to take 5 of the extract oral capsules of treatment ischemic necrosis of femoral head of the present invention, and days three times oral.Postoperative 45 days, check are taken the photograph sheet and are shown that femoral head bone graft lobe healing state is satisfied, cancel skin traction of lower extremity then, the up right lower extremity CPM of bed functional exercise, and postoperative is left hospital after holding up in 60 days and turning down ground part weight training exercise.Postoperative was abandoned and is turned walking in five months, and postoperative was withdrawn this medicine in six months, and employment on duty again, followed up a case by regular visits to Harris scoring 98 minutes in the recent period, and not only the routine work life is unrestricted, can also be engaged in sports to a certain degree.
Case two, open * *, the woman, 35 years old, the bank clerk, there are not obvious inducement left inguinal region and left knee pain three months, once in outer court's diagnosis " prolapse of lumbar intervertebral disc ", the MRI that goes once more because of failing to respond to any medical treatment turns out to be " left side ischemic necrosis of femoral head ", on May 16th, 1998 was admitted to hospital and requires operative treatment, AD: the Harris scoring is 65 minutes before " the left side ischemic necrosis of femoral head; II phase ", art, and the back of being admitted to hospital is with 5 of this medicines, days three times oral, left lower extremity continues to prepare before the skin traction art, two weeks back drug withdrawal (first three day of art), and June 3 is in continuous epidural anesthesia descending " left side ischemic necrosis of femoral head focal cleaning; band revolves thigh lateral blood vessel ascending branch ilium lobe and shifts prothesis ", row lower-left primary minimum heavy weight hide traction braking, postoperative recovered to take 5 of the extract oral capsules of treatment ischemic necrosis of femoral head of the present invention in three days, and days three times oral.Postoperative 46 days, check are taken the photograph sheet and are shown that femoral head bone graft lobe healing state is satisfied, the cancellation skin traction of lower extremity, the up lower limb CPM of bed functional exercise, postoperative held up in 55 days turn down part weight training exercise and leaving hospital.Postoperative was abandoned and is turned walking in five months, and postoperative was withdrawn this medicine and on duty again in eight months, followed up a case by regular visits to Harris scoring 100 minutes in the recent period, can carry out violent sports as playing badminton.
Case three, Song * *, woman, 32 years old, nurse.Went to a doctor in uncomfortable one month because of right inguinal region pain, diagnose after outpatient service row hip joint X line is taken the photograph sheet and CT scan: " right side ischemic necrosis of femoral head, I phase " Harris scoring 75 minutes.On July 9th, 2000 was admitted to hospital, the row right lower extremity continues the skin traction braking, 6 of this medicines, and days three times are oral, leave hospital after January, be admitted to hospital once more after two months at interval, still, leave hospital after January by the scheme treatment of being hospitalized for treatment last time, Yu Jiazhong has a rest and resumes work after two months, kept oral medicine totally one year, be 6 the first half, day three times; Be 4 later six months, day three times.Followed up a case by regular visits to Harris scoring in the recent period 100 minutes, the X line is taken the photograph sheet and CT scan and is all shown the calcification of femoral head inner disease foci and dwindle, and recovers daily comings and goings fully.
Claims (3)
1. oral preparation of Chinese traditional medicinal for the treatment of ischemic necrosis of femoral head, it is characterized in that it being that Chinese medicine by following weight percentage ratio is prepared from: Radix Angelicae Sinensis 10～30%, Radix Salviae Miltiorrhizae 10～30%, the Radix Astragali 20～50%, Rhizoma Corydalis 5～15%, Flos Carthami 5～15%, Olibanum 5～15%, Myrrha 5～15%, Moschus 0.1～0.3%.
2. a kind of oral preparation of Chinese traditional medicinal for the treatment of ischemic necrosis of femoral head according to claim 1 can be capsule, tablet or powder.
3. a kind of preparation technology who treats the oral preparation of Chinese traditional medicinal of ischemic necrosis of femoral head according to claim 1 is characterized in that being undertaken by following process:
The first step: get following clean pharmaceutical decocting piece by weight percentage: Radix Angelicae Sinensis 10～30%, Radix Salviae Miltiorrhizae 10～30%, the Radix Astragali 20～50%, Rhizoma Corydalis 5～15%, Flos Carthami 5～15%, Olibanum 5～15%, Myrrha 5～15% was in 60～80 ℃ of dryings 4～5 hours;
Second step: the medical material that above-mentioned drying is good adopts medicinal pulverizer, uses and mixes comminuting method, pulverizes the back and crosses 100 mesh sieves, gets the fine powder mixing, and is standby;
The 3rd step: other gets percentage by weight is 0.1～0.3% Moschus, adopts bottoming chromatography and equivalent incremental method and above-mentioned standby fine powder cover to grind mixing;
The 4th step: the material of above-mentioned mixing is made capsule, tablet or powder, promptly.
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| CNB2005102000736A CN100335079C (en) | 2005-02-02 | 2005-02-02 | Oral Chinese medicine preparation of caput femoris ischemic necrosis and production thereof |
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| CNB2005102000736A CN100335079C (en) | 2005-02-02 | 2005-02-02 | Oral Chinese medicine preparation of caput femoris ischemic necrosis and production thereof |
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| CN100335079C true CN100335079C (en) | 2007-09-05 |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102552843B (en) * | 2011-12-12 | 2014-06-04 | 沃树峰 | Medicament composite for curing osteoarthropathy |
| CN105687622A (en) * | 2016-01-29 | 2016-06-22 | 山东益宝生物制品有限公司 | Medicine for treating femoral head necrosis and preparation method thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1141173A (en) * | 1995-07-24 | 1997-01-29 | 赵奕成 | Serial medicament for rehabilitation of spinal column |
| CN1451430A (en) * | 2003-05-08 | 2003-10-29 | 吴振平 | Medicine composition for treating ischemic necrosis of femur head and preparing process thereof |
| CN1569199A (en) * | 2004-04-27 | 2005-01-26 | 武英 | Medicinal prescription for treating aseptic necrosis of femur head |
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2005
- 2005-02-02 CN CNB2005102000736A patent/CN100335079C/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1141173A (en) * | 1995-07-24 | 1997-01-29 | 赵奕成 | Serial medicament for rehabilitation of spinal column |
| CN1451430A (en) * | 2003-05-08 | 2003-10-29 | 吴振平 | Medicine composition for treating ischemic necrosis of femur head and preparing process thereof |
| CN1569199A (en) * | 2004-04-27 | 2005-01-26 | 武英 | Medicinal prescription for treating aseptic necrosis of femur head |
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| CN1679877A (en) | 2005-10-12 |
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