CN106039232A - Analgesic and preparation method thereof - Google Patents

Analgesic and preparation method thereof Download PDF

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Publication number
CN106039232A
CN106039232A CN201610602412.1A CN201610602412A CN106039232A CN 106039232 A CN106039232 A CN 106039232A CN 201610602412 A CN201610602412 A CN 201610602412A CN 106039232 A CN106039232 A CN 106039232A
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weight
pain
radix
rhizoma
weight portions
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CN201610602412.1A
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孙文朋
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孙文朋
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/045Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/24Mucus; Mucous glands; Bursa; Synovial fluid; Arthral fluid; Excreta; Spinal fluid
    • AHUMAN NECESSITIES
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    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/56Materials from animals other than mammals
    • A61K35/616Echinodermata, e.g. starfish, sea cucumbers or sea urchins
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    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/13Coniferophyta (gymnosperms)
    • A61K36/15Pinaceae (Pine family), e.g. pine or cedar
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    • A61K36/18Magnoliophyta (angiosperms)
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    • A61K36/23Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
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    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/28Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
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    • A61K36/75Rutaceae (Rue family)
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    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/896Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
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    • A61K36/899Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
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    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/90Smilacaceae (Catbrier family), e.g. greenbrier or sarsaparilla
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    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/333Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
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Abstract

The invention provides an analgesic, prepared from the following raw materials: radix stephaniae tetrandrae, herba speranskiae tuberculatae, rhizoma corydalis, fructus evodiae, trogopterus dung, myrrh, sea cucumber, rhizoma smilacis glabrae, tabasheer, pine nodular branch, radix clematidis, Chinese angelica, radix paeoniae alba, raw liquorice root, borneol, rhizoma curcumae, semen coicis, raw rhizoma atractylodis macrocephalae and herba cistanche. The traditional Chinese medicine preparation is provided on this basis; by means of a great deal of clinical medication observation, laboratory studies and relevant safety testing, the traditional Chinese medicine preparation provided by the invention is proved to be precise and appropriate in prescription formulation and compatibility, definite in treatment effect, safe and reliable, and is clinically promoted in a dosage form of acupoint injection, thus bringing good news to patients beset by the pain of various bone diseases.

Description

One relieves the pain agent and preparation method thereof
Technical field
The present invention relates to technical field of Chinese medicine, particularly relate to a kind of Chinese Traditional Medicine into Point liquid for alleviating ostalgia Relieve the pain agent and preparation method thereof.
Background technology
Osteopathia from specialty angle for be " osteopathia ", it is one of orthopaedic disease three serious disease, other two kinds of difference For " positive osteology " and " injury of tendon and muscle ".Osteopathia is also modal disease in orthopaedic disease, and it is broadly divided into: congenital osteopathia, generation Thanking property osteopathia, osteonecrosis, occupational osteopathia, endemicity osteopathia, joint degenerative osteopathy, bone tumor, bone carbuncle, bone tuberculosis, bone A few bulk contents such as joint arthromyodynia, myopathy, clonic spasm of the muscle.Here please every reader it is to be noted that our described at ordinary times " osteopathia " from It is incorrect from the point of view of technical term, it may be said that one-tenth is " orthopaedic disease " or more specifically sick kind.
Osteopathia generally comprises: rheumatic arthritis, rheumatoid arthritis, degenerative osteoarthritis, cervical spondylosis, lumbar spondylosis, Scapulohumeral periarthritis, hyperosteogeny, femur head necrosis, puerperal exposure to wind etc..
Rheumatic arthritis is a kind of common acute or chronic ICT.Can recurrent exerbation involve heart. Clinical one with joint and muscle migrans miserable, heavily write, pain is characterized. belong to allergic disease. be the main of rheumatic fever One of performance, how with febris acuta and arthralgia onset.
Rheumatoid arthritis is a kind of chronic generalized autoimmune disease being characterized with articular synovitis.Synovial membrane Scorching persistently recurrent exerbation, may result in the destruction of intraarticular cartilage and bone, joint function disturbance, even maimed person.Vasculitis pathological changes is tired out And each organ of whole body, therefore primary disease is also called rheumatoid disease.
Degenerative osteoarthritis, also known as hypertrophiarthritis, refers to that some old peoples usually have lumbago, skelalgia, arthralgia. Owing to it is more common in old people, thus also referred to as senile arthritis.Senescent deterioration, is cause degenerative osteoarthritis main Reason.
Cervical spondylosis, also known as cervical spine syndrome, is osteoarthritis of cervical spine, proliferative cervical spondylosis, cervical syndrome, cervical vertebra The general name of Spondylosis disease, is a kind of illness changing into basis with degeneration pathology.Show as intervertebral disc degradation itself and Its insecondary a series of pathological changes, such as vertebra joint unstability, loosen;Nucleus pulposus or abjection;Bony spur is formed;Ligament is plump and continues The spinal canal stenosis etc. sent out, stimulates or has oppressed the tissues such as neighbouring nerve root, spinal cord, vertebral artery and cervical region sympathetic nerve, and drawing Play the syndrome of various sings and symptoms.
Scapulohumeral periarthritis is the common disease as cardinal symptom with shoulder arthralgia and inconvenient activity.Primary disease send out well the age 50 About Sui, women sickness rate is slightly above male, is more common in physical labourer.As can not get effectively treating, it is possible to serious shadow Ring the functional activity of shoulder joint.According to clinical observation, hospital's common medicine closes Sheng hall ancestor and is treated, and primary disease shoulder joint in early days is paroxysm Property pain, often because of Changes in weather and tired and induce, the most gradually develop into rest pain, and gradually increase the weight of, light night in daytime weight, Shoulder joint is the most limited to the actively and passively activity of all directions.When shoulder is by tractive, can cause and have an intense pain.
Bone matrix hyperplasia is also called hyperplastic osteoarthritis, osteoarthritis (OA), degenerative joint disease, senile joint Scorching, hypertrophiarthritis, is owing to constituting soft tissue degeneration, the degenerations such as the cartilage in joint, intervertebral disc, ligament, joint margins shape Become bony spur, the changes such as synovial membrane is plump, and osteoclasia occurs, cause insecondary hyperosteogeny, cause joint deformity, when by different During Chang Zaihe, cause arthralgia, a kind of disease of the symptoms such as limitation of activity.
Femur head necrosis, also known as ischemic necrosis of femoral head, for one of common osteoarthritis.Mostly because of rheumatism, blood The illness such as liquid disease, bends, burn cause, and first destroy the blood supply of adjacent joints covering weave, in turn result in necrosis.It is main Symptom, gradually develops into rest pain from discontinuity pain, then is caused muscle spasm, joint motion to be restricted by pain, Eventually cause and seriously disable and walk lamely.
Osteosarcoma is one the most common in bone malignant tumour, is to develop from Interstitial cell system, and tumor mushrooms out It is owing to tumor directly or indirectly forms tumor osteoid tissue and osseous tissue through cartilage phase.Tumor locus occurs in various degree Pain is the most common and obvious symptom of osteosarcoma, the tumor tissues expanded destroy cortical bone, stimulates periosteum teleneuron Cause.Pain can be developed into the persistence after several weeks by intermittence in early days, and the degree of pain can strengthen.Lower limb pain can Occur that keeping away pain property walks lamely.
Osteopathia like this, although the reason of its morbidity is different, symptom is different, prognosis is different, but annoyings several always The symptom of class patient's curative effect and subjective feeling is------pain.The most preferably alleviating pain, reduces because taking tablet for alleviating pain very To analgesic such as injection dolantins, affect doctor and patient.
In recent years, Chinese medicine is gradually paid close attention to by people for the therapeutical effect of ostalgia, and the traditional Chinese medical science thinks that osteopathia causes Pain many " stasis of blood, heat, poison, empty ", it is therefore proposed that corresponding therapeutic rule, whether for oral administration, the external of Chinese medicine, or pin Moxibustion, sunkening cord all serves good therapeutical effect, rapid pain relief, reduces recurrent pain, coordinates Western medicine for protopathy Treatment, cure diseases, make the quality of life of patient be improved, and then the incidence rate of mental disorder can be decreased, therefore, Chinese medicine preparation of the present invention is exactly to propose on this basis, observes through substantial amounts of clinical application, laboratory research and relevant After safety detection, it was demonstrated that the prescription compatibility of Chinese medicine preparation of the present invention is precise and appropriate, and therapeutic effect determines, safety is reliable, with acupuncture point The dosage form of injection carries out clinical expansion, brings Gospel to the various patients perplexed because of ostalgia.
Summary of the invention
For solving above-mentioned technical problem, only the invention provides a kind of Chinese Traditional Medicine into Point liquid for alleviating ostalgia Pain agent, its compatibility is precise and appropriate, and therapeutic effect determines, safety is reliable, carries out clinical expansion with the dosage form of acupoint injection therapy liquid, to various The patient perplexed because of ostalgia brings Gospel.
The present invention provides a kind of Chinese Traditional Medicine into Point liquid for alleviating ostalgia to relieve the pain agent, and its crude drug includes preventing Oneself, Herba speranskiae tuberculatae, Rhizoma Corydalis, Fructus Evodiae, Oletum Trogopterori, Myrrha, Stichopus japonicus, Rhizoma Smilacis Glabrae, Concretio Silicea Bambusae, Lignum Pini Nodi, Radix Clematidis, Radix Angelicae Sinensis, the Radix Paeoniae Alba, Radix Glycyrrhizae, Borneolum Syntheticum, Rhizoma Curcumae, Semen Coicis, Rhizoma Atractylodis Macrocephalae and Herba Cistanches.
Wherein, described Herba speranskiae tuberculatae: Radix Stephaniae Tetrandrae: the consumption mass ratio of Rhizoma Corydalis three is 3: 1: 3.
Wherein, the described injection weight portion of each crude drug in agent that relieves the pain is respectively Radix Stephaniae Tetrandrae 10 weight portion, Herba speranskiae tuberculatae 30 weight Amount part, Rhizoma Corydalis 30 weight portion, Fructus Evodiae 11 weight portion~13 weight portions, Oletum Trogopterori 14 weight portion~16 weight portions, Myrrha 14 Weight portion~16 weight portions, Stichopus japonicus 14 weight portion~16 weight portions, Rhizoma Smilacis Glabrae 29 weight portion~31 weight portions, Concretio Silicea Bambusae 9 weight Part~11 weight portions, Lignum Pini Nodi 9 weight portion~11 weight portions, Radix Clematidis 19 weight portion~21 weight portions, Radix Angelicae Sinensis 29 weight portion~31 Weight portion, the Radix Paeoniae Alba 29 weight portion~31 weight portions, Radix Glycyrrhizae 19 weight portion~21 weight portions, Borneolum Syntheticum 9 weight portion~11 weight portions, Rhizoma Curcumae 14 weight portion~16 weight portions, Semen Coicis 29 weight portion~31 weight portions, Rhizoma Atractylodis Macrocephalae 39 weight portion~41 weight portions, meat desert Rong 29 weight portion~31 weight portions.
Wherein, the described injection weight portion of each crude drug in agent that relieves the pain is respectively Radix Stephaniae Tetrandrae 10 weight portion, Herba speranskiae tuberculatae 30 weight Amount part, Rhizoma Corydalis 30 weight portion, Fructus Evodiae 12 weight portion, Oletum Trogopterori 15 weight portion, Myrrha 15 weight portion, Stichopus japonicus 15 weight portion, Rhizoma Smilacis Glabrae 30 weight portion, Concretio Silicea Bambusae 10 weight portion, Lignum Pini Nodi 10 weight portion, Radix Clematidis 20 weight portion, Radix Angelicae Sinensis 30 weight portion, the Radix Paeoniae Alba 30 Weight portion, Radix Glycyrrhizae 20 weight portion, Borneolum Syntheticum 10 weight portion, Rhizoma Curcumae 15 weight portion, Semen Coicis 30 weight portion, Rhizoma Atractylodis Macrocephalae 40 weight Part, Herba Cistanches 30 weight portion.
The present invention also provides for the preparation method of above-mentioned injection, comprising:
The first step, weighs respectively by each crude drug component, clean, mix by described weight portion, add relative to The ethanol that determining alcohol is 80% of 6~8 times of the mixture quality obtained, extracts after being heated to reflux 5 hours, filters, obtains first Filtrate;Filtering residue is dissolved with the ethanol of the determining alcohol 80% of 4 times of the mixture quality relative to acquisition again, is heated to reflux Extract after 3 hours, filter, obtain the second filtrate;Merging the first filtrate and the second filtrate, decompression recycling ethanol is also concentrated into Liquor strength is 0.8g crude drug/mL, upper D101 macroporous adsorbent resin eluting, and resin volume is 5 times of concentrated medicament volume, first uses The deionized water of 7 times of resin column volumes or distilled water eluting, then be 90% ethanol elution with the determining alcohol of 5 times of resin column volumes, Collecting ethanol elution, concentrating under reduced pressure removes ethanol, is dried and is ground into powder;
Second step, adds water for injection in first step gained powder, and crude drug corresponding in every 1000ml water for injection is 300g, slight fever promotes that powder dissolves completely, stands overnight, and 0.45 μm microporous filter membrane filters to obtain filtrate, and gained filtrate adds pH and adjusts Joint agent Fructus Citri Limoniae acid for adjusting pH is 6.2~6.8, gained solution sterilization, subpackage, both.
Useful technique effect
The agent compatibility that relieves the pain that the present invention provides is precise and appropriate, and therapeutic effect determines, safety is reliable, with the dosage form of acupoint injection therapy liquid Carry out clinical expansion, bring Gospel to the various patients perplexed because of ostalgia.
Detailed description of the invention
Chinese medicine is gradually paid close attention to by people for the therapeutical effect of ostalgia, and the traditional Chinese medical science thinks that the pain that osteopathia causes is many " stasis of blood, heat, poison, empty ", it is therefore proposed that corresponding therapeutic rule, whether for oral administration, the external of Chinese medicine, or acupuncture, sunkens cord all Serve good therapeutical effect, rapid pain relief, reduce recurrent pain, coordinate Western medicine for the treatment of protopathy, cure Disease, makes the quality of life of patient be improved, and then can decrease the incidence rate of mental disorder, therefore, in the present invention Medicine preparation is exactly on this basis, the effective prescription drawn after clinical verification.
The present invention provides a kind of Chinese Traditional Medicine into Point liquid for alleviating ostalgia to relieve the pain agent, and its crude drug includes preventing Oneself, Herba speranskiae tuberculatae, Rhizoma Corydalis, Fructus Evodiae, Oletum Trogopterori, Myrrha, Stichopus japonicus, Rhizoma Smilacis Glabrae, Concretio Silicea Bambusae, Lignum Pini Nodi, Radix Clematidis, Radix Angelicae Sinensis, the Radix Paeoniae Alba, Radix Glycyrrhizae, Borneolum Syntheticum, Rhizoma Curcumae, Semen Coicis, Rhizoma Atractylodis Macrocephalae and Herba Cistanches.
The pungent row of the many tools of Chinese medicine analgesic, the pungent property dissipated, circulation of qi promoting of often holding concurrently of invigorating blood circulation, there is good analgesic effect, with " heat clearing away, solution Poison, dissipating blood stasis, qi-restoratives " it is the prescription of method for the treatment of.Chinese Traditional Medicine into Point liquid of the present invention is with Herba speranskiae tuberculatae, Radix Stephaniae Tetrandrae, Rhizoma Corydalis three medicine as monarch drug Group, wherein monarch drug Herba speranskiae tuberculatae, all herbal medicine among the people, cure cold, traumatic injury, skin infection, eczema, scabies are controlled in external.Pharmacology Research, this pharmaceutically active ingredient is similar to Salicylates effect, has well analgesia, antiinflammatory, the effect of the wound that sterilizes, holds back, Bone pain is had very well for therapeutic effect, Radix Stephaniae Tetrandrae wind-expelling pain-stopping, inducing diuresis to remove edema, all kinds of arthromyodynias is had and well dispels Wind dehumidifying, clearing away heat to alleviate pain effect, have good therapeutical effect for rheumatism, characteristic of stock arthrosis etc., and Rhizoma Corydalis is with tuber It is used as medicine, containing more than 20 kinds of alkaloids, for promoting the circulation of QI to relieve pain, promoting blood circulation to remove blood stasis, traumatic injury etc., the pain tool caused for all kinds of blood stasis Having good mitigation, have good antiinflammatory, detumescence effect simultaneously, found by clinical research, three medicine ratios are with deep Grass: Radix Stephaniae Tetrandrae: Rhizoma Corydalis ratio is be optimal at 3: 1: 3, if changing the use ratio of each medicine, does not then reach clinic anticipated optimal set and imitates Really, such as, if reducing the using dosage of Herba speranskiae tuberculatae, the party's heat-clearing toxin-expelling functions reduces, and antiinflammatory action declines more apparent, reduces anti- Own consumption, its expelling wind and removing dampness effect is the most notable, although in zoopery, index cannot preferably characterize, but in clinical practice The most notable, and reduce the using dosage of Rhizoma Corydalis, its analgesic effect substantially reduces, and fails to embody more preferable pain relieving effect Really, therefore, on the premise of optimal dose, guarantee the party has preferable curative effect.Use Concretio Silicea Bambusae clear heat and eliminate phlegm, the cool heart Effect of arresting convulsion, uses the medicines such as Lignum Pini Nodi, Radix Clematidis, Rhizoma Smilacis Glabrae to coordinate Radix Stephaniae Tetrandrae, strengthens monarch drug expelling wind and dampness, clearing away heat to alleviate pain effect, Strengthening its antiinflammatory, detumescence effect, wherein Lignum Pini Nodi dispeiling pathogenic wind and removing dampness, for anemofrigid-damp arthralgia, severe and migratory arthralgia pain, foot numbness flaccidity is soft, traumatic pain Having good curative effect, Radix Clematidis has wind-damp dispelling, the meridian dredging effect, finds in modem medical practices, and this medicine is for bony spur, foot The bone pain such as calcaneodynia have good curative effect, and particularly insensitive impediment effect especially is notable, Rhizoma Smilacis Glabrae have dehumidifying of well detoxifying, Effect of easing joint movement, for all kinds of limbs contractures, bones and muscles pain has a good therapeutical effect, use Oletum Trogopterori, Fructus Evodiae, The medicine such as Myrrha, Rhizoma Curcumae, coordinates monarch drug Rhizoma Corydalis, promotes its vital energy regualting and blood circulation-promoting, blood-activating analgetic effect, wherein Oletum Trogopterori regulating QI to relieve pain merit Imitating the most notable, Fructus Evodiae is good at dispersing cold for relieving pain, and promoting blood circulation, removing blood stasis and relieving pain is more partial to by Rhizoma Curcumae, Myrrha two medicine, and blood stasis must be dispelled, newly Blood must be raw, improves rapidly the twinge etc. that local causes because of blood stasis, and during for having wound or closed fracture, it promotes local Body tissue repair function have also been obtained clinical verification, and all medicines share as ministerial drug;Because how empty the cause of disease of primary disease is, therefore, this Bright Chinese medicine preparation adds the medicine of benefiting QI and nourishing blood, reinforcing spleen and kidney, such as Radix Angelicae Sinensis, the Radix Paeoniae Alba, Semen Coicis, Rhizoma Atractylodis Macrocephalae, Herba Cistanches, Stichopus japonicus Deng, Semen Coicis is good at invigorating spleen to remove dampness, and Rhizoma Atractylodis Macrocephalae is good at spleen invigorating and is helped fortune, and two medicines share, and temper must be good for, and QI and blood biochemistry is active, meat desert Rong is good at warming and recuperating the kidney-YANG, and Stichopus japonicus is good at the moon of nourishing the lung and kidney, and the important medicine pair that Radix Angelicae Sinensis, the Radix Paeoniae Alba two medicine are nourshing blood and promoting blood circulation, therefore, All medicines share, and QI and blood, with benefit, the negative and positive people having the same aspiration and interest, has preferable qi-restoratives effect;Add Radix Glycyrrhizae heat-clearing and toxic substances removing, harmonizing yingfen and weifen, with Time again can be with coordinating the actions of various ingredients in a prescription, for making medicine.
The described injection weight portion of each crude drug in agent that relieves the pain most preferably is respectively Radix Stephaniae Tetrandrae 10 weight portion, Herba speranskiae tuberculatae 30 weight Amount part, Rhizoma Corydalis 30 weight portion, Fructus Evodiae 11 weight portion~13 weight portions, Oletum Trogopterori 14 weight portion~16 weight portions, Myrrha 14 Weight portion~16 weight portions, Stichopus japonicus 14 weight portion~16 weight portions, Rhizoma Smilacis Glabrae 29 weight portion~31 weight portions, Concretio Silicea Bambusae 9 weight Part~11 weight portions, Lignum Pini Nodi 9 weight portion~11 weight portions, Radix Clematidis 19 weight portion~21 weight portions, Radix Angelicae Sinensis 29 weight portion~31 Weight portion, the Radix Paeoniae Alba 29 weight portion~31 weight portions, Radix Glycyrrhizae 19 weight portion~21 weight portions, Borneolum Syntheticum 9 weight portion~11 weight portions, Rhizoma Curcumae 14 weight portion~16 weight portions, Semen Coicis 29 weight portion~31 weight portions, Rhizoma Atractylodis Macrocephalae 39 weight portion~41 weight portions, meat desert Rong 29 weight portion~31 weight portions.
The described injection weight portion of each crude drug in agent that relieves the pain most preferably is respectively Radix Stephaniae Tetrandrae 10 weight portion, Herba speranskiae tuberculatae 30 weight Amount part, Rhizoma Corydalis 30 weight portion, Fructus Evodiae 12 weight portion, Oletum Trogopterori 15 weight portion, Myrrha 15 weight portion, Stichopus japonicus 15 weight portion, Rhizoma Smilacis Glabrae 30 weight portion, Concretio Silicea Bambusae 10 weight portion, Lignum Pini Nodi 10 weight portion, Radix Clematidis 20 weight portion, Radix Angelicae Sinensis 30 weight portion, the Radix Paeoniae Alba 30 Weight portion, Radix Glycyrrhizae 20 weight portion, Borneolum Syntheticum 10 weight portion, Rhizoma Curcumae 15 weight portion, Semen Coicis 30 weight portion, Rhizoma Atractylodis Macrocephalae 40 weight Part, Herba Cistanches 30 weight portion.
The present invention also provides for the preparation method of above-mentioned injection, comprising:
The first step, weighs respectively by each crude drug component, clean, mix by described weight portion, add relative to The ethanol that determining alcohol is 80% of 6~8 times of the mixture quality obtained, extracts after being heated to reflux 5 hours, filters, obtains first Filtrate;Filtering residue is dissolved with the ethanol of the determining alcohol 80% of 4 times of the mixture quality relative to acquisition again, is heated to reflux Extract after 3 hours, filter, obtain the second filtrate;Merging the first filtrate and the second filtrate, decompression recycling ethanol is also concentrated into Liquor strength is 0.8g crude drug/mL, upper D101 macroporous adsorbent resin eluting, and resin volume is 5 times of concentrated medicament volume, first uses The deionized water of 7 times of resin column volumes or distilled water eluting, then be 90% ethanol elution with the determining alcohol of 5 times of resin column volumes, Collecting ethanol elution, concentrating under reduced pressure removes ethanol, is dried and is ground into powder;
Second step, adds water for injection in first step gained powder, and crude drug corresponding in every 1000ml water for injection is 300g, slight fever promotes that powder dissolves completely, stands overnight, and 0.45 μm microporous filter membrane filters to obtain filtrate, and gained filtrate adds pH and adjusts Joint agent Fructus Citri Limoniae acid for adjusting pH is 6.2~6.8, gained solution sterilization, subpackage, both.
Radix Stephaniae Tetrandrae: bitter in the mouth, pungent, cold in nature, enter bladder, kidney channel, there is inducing diuresis to remove edema, the function of wind-expelling pain-stopping, in water is wet Stop the cards such as caused edema, dysuria, rheumatic arthralgia.
Herba speranskiae tuberculatae: latin name PhrymaleptostachyaL.subsp.asiatica (Hara) Kitamura, sweet in the mouth, Pungent, warm in nature, enter lung, liver two warp, there is effect of expelling wind and dampness, promoting blood circulation and stopping pain, for rheumatic arthritis;External is controlled skin infection and is swollen Poison.
Rhizoma Corydalis: bitter in the mouth, pungent, warm in nature, return liver, the heart, stomach warp, there is benefaction and wander away, can rise and can drop, there is promoting blood circulation to remove blood stasis, Effect of promoting the circulation of QI to relieve pain, cures mainly obstruction of qi in the chest and cardialgia, coerces rib, all pains of gastral cavity abdomen, headache, lumbago, colicky, bones and muscles pain, dysmenorrhea, amenorrhea, Puerperal, the stasis of blood was suffered from abdominal pain, and traumatic injury etc. is demonstrate,proved.
Fructus Evodiae: property heat, acrid in the mouth, hardship, has dispersing cold for relieving pain, stopping nausea and vomiting by lowering the adverse flow of QI, effect of supporing yang antidiarrheal, is used for the moon of fainting Headache, colic of cold type stomachache, the disturbance of lower legs due to pathogenic cold and dampness, abdominal pain during menstruation, abdominal distention, vomit acid regurgitation, Diarrhoea, external treatment aphtha, hypertension etc. Card.
Oletum Trogopterori: sweet in the mouth, warm in nature, enter Liver Channel, there is effect of promoting blood circulation to remove blood stasis, have a pain for trusted subordinate's congestion, dysmenorrhea, blood stasis Amenorrhea, curing postpartum bleeding stomachache etc. is demonstrate,proved.
Myrrha: bitter in the mouth, pungent, property is put down, and enters liver, spleen, the heart, kidney channel, has effect of promoting blood circulation and stopping pain, detumescence and promoting granulation, cure mainly chest and abdomen Stasis of blood pain, dysmenorrhea, amenorrhea, lump in the abdomen, traumatic injury, carbuncle skin infection, acute appendicitis, conjunctival congestion and swelling pain etc. are demonstrate,proved.
Stichopus japonicus: sweet-salty, the kidney invigorating, benefit marrow, take the photograph urine, flaccidity, its benefit warm in nature, foot enemy's ginseng, therefore named Stichopus japonicus are treated in tonifying YANG.Sea Ginseng has raising memory, delays gonad old and feeble, prevents arteriosclerosis and antitumor etc. from acting on.
Rhizoma Smilacis Glabrae: sweet in the mouth, light, property puts down, Liver Channel;Stomach warp;Spleen channel, has removing toxic substances, dehumidifying, the effect in profit joint, cures mainly prunus mume (sieb.) sieb.et zucc. Poison, stranguria with turbid discharge, muscles and bones spasm and pain, tinea pedis, furuncle treats skin ulcer, carbuncle, scrofula, the limbs contracture caused by syphilis and mercurialism, bones and muscles pain etc. Card.
Concretio Silicea Bambusae: sweet in the mouth, cold in nature, there is clear heat and eliminate phlegm, effect of cool heart arresting convulsion, cure mainly calentura coma delirium, middle wind-phlegm Fan in silence, twitch, epilepsy by infantile convulsion.Phlegm-heat coughs etc. are demonstrate,proved.
Lignum Pini Nodi: bitter in the mouth, warm in nature, return Liver Channel.Effect is dispeiling pathogenic wind and removing dampness, pain relieving.For main anemofrigid-damp arthralgia, severe and migratory arthralgia pain;Foot Numbness flaccidity is soft;Traumatic pain etc. are demonstrate,proved.
Radix Clematidis: latin name clematidisradixetrhizoma, acrid in the mouth, salty, warm in nature, slightly poisonous, enter bladder warp, tool Having expelling wind and removing dampness, removing obstruction in the collateral to relieve pain, expectorant water, dissipate effect of the hypochondriac lump, cure mainly gout insensitive impediment, rheumatic arthralgia, numb limbs and tense tendons, waist knee joint is cold Bitterly, muscle arteries and veins contracture, joint stuffiness, tinea pedis, malaria, lump in the abdomen, tetanus, tonsillitis, all a fishbone or other bone caught in the throat pharynxs etc. are demonstrate,proved.
Radix Angelicae Sinensis: latin name AngelicaeSinensisRadix, sweet in the mouth, pungent, warm in nature, enter liver, the heart, spleen channel, have and enrich blood Invigorate blood circulation, menstruction regulating and pain relieving, effect of loosening bowel to relieve constipation, cure mainly having a dizzy spell of deficiency of heart-blood, fatigue and weakness, shortness of breath and palpitation, the sea of blood is empty Void, the cold and deficiency of CHONG and REN meridians or the menoxenia of congestion retardance, dysmenorrhoea, produce or suffer from abdominal pain, and other blood stasis are had a pain and deficiency of YIN insufficiency of blood dryness of the intestine it Constipation etc. are demonstrate,proved.
The Radix Paeoniae Alba: latin name PaeoniaeRadixAlba, bitter in the mouth, acid, cool in nature, enter liver, spleen channel, there is nourishing blood to suppress the hyperactive liver, in delaying Pain relieving, yin fluid astringing is received effect of antiperspirant, is cured mainly the chest and abdomen pain over the hypochondriac region, dysentery stomachache, spontaneous sweating, fever due to yin deficiency, menoxenia, collapse Leakage, carries inferior card.
Radix Glycyrrhizae: sweet in the mouth, property puts down, enters 12 warps, have a heat-clearing and toxic substances removing, is in harmonious proportion the property of medicine, and the effect of expelling phlegm for arresting cough is, and can spleen invigorating In with, relieving spasm to stop pain, it is mainly used in the abdominal distension and anorexia of weakness of the spleen and stomach, weak;Contracture pain in abdomen can be alleviated, relax some medicine Strong and the toxicity of thing, alleviate medicine to the toxic and side effects of body or to gastrointestinal stimulate, by add Radix Glycyrrhizae can play benefit Gas neutralizes, and is in harmonious proportion the effect of each component.
Borneolum Syntheticum: latin name BorneolumSyntheticum, acrid in the mouth, hardship, cool in nature, enter the heart, lung meridian, there is logical all keys, dissipate Stagnated fire, removing nebula improving eyesight, effect of reducing swelling and alleviating pain, cure mainly apoplexy locked mouth, calentura coma, infantile convulsion expectorant fan, deafness with qi stagnation, sore throat, mouth Skin ulcer, otitis media, carbuncle, hemorrhoid, mesh also nebula film, enterobiasis etc. is demonstrate,proved.
Rhizoma Curcumae: acrid in the mouth, hardship, warm in nature, enter liver, spleen channel, there is removing blood stasis circulation of qi promoting, effect of removing food stagnancy pain relieving, for qi depression to blood stasis Caused lump in the abdomen mass in the abdomen, chest and abdomen stasis of blood pain, amenorrhea, dysmenorrhea, abdominal distention, traumatic injury, blood stasis swells and ache to wait and demonstrate,proves.
Semen Coicis: latin name CoicisSemen, sweet in the mouth, light, cold nature, enter lung, spleen, large intestine channel, there is invigorating the spleen to arrest diarrhea, Diuretic eliminating impediment, effect of row's skin ulcer pus, cure mainly having loose bowels of wet tired lung stomach;Damp invades the hydrosarca of stain skin, dysuria;Damp and hot Hinder the numbness in QI and blood pass to and scorchingly hot pent up in lung intestinal lung abscess, the card such as acute appendicitis.
Rhizoma Atractylodis Macrocephalae: latin name atractylodismacrocephalaerhizoma, bitter in the mouth, sweet, warm in nature, enter spleen, stomach warp, There is invigorating the spleen and benefiting QI, dampness diuretic, hidroschesis, antiabortive effect, for weakness of the spleen and stomach, lack of appetite distension, fatigue and weakness, have loose bowels, water Wet stop, phlegm retention, edema, exterior deficiency spontaneous perspiration etc. is demonstrate,proved.
Herba Cistanches: for Orobanchaceae Cistanche Hoffmgg. et Link plants Herba Cistanches and the fleshy stem of Cistanche Tubulosa, latin name Herbacistanches, sweet in the mouth, salty, warm in nature, enter kidney, large intestine channel, have kidney-replenishing, benefiting essence-blood, the effect of loosening bowel to relieve constipation, it is used for Kidney yang deficiency, the impotence and premature ejaculation of asthenia of essence and blood, sterility and infertility, soreness of waist and knee joint, Hiccough and deaf, frequent micturition urine number, suffer from a deficiency of the kidney dryness of the intestine and product The constipation of rear blood deficiency, after being ill deficiency of body fluid etc. are demonstrate,proved.
Embodiment is below used to describe embodiments of the present invention in detail, whereby to the present invention how application technology means Solve technical problem, and the process that realizes reaching technique effect can fully understand and implement according to this.
Embodiment 1 injection 1
By Radix Stephaniae Tetrandrae 10g, Herba speranskiae tuberculatae 30g, Rhizoma Corydalis 30g, Fructus Evodiae 12g, Oletum Trogopterori 15g, Myrrha 15g, Stichopus japonicus 15g, soil Poria 30g, Concretio Silicea Bambusae 10g, Lignum Pini Nodi 10g, Radix Clematidis 20g, Radix Angelicae Sinensis 30g, Radix Paeoniae Alba 30g, Radix Glycyrrhizae 20g, Borneolum Syntheticum 10g, Rhizoma Curcumae 15g, Semen Coicis 30g, Rhizoma Atractylodis Macrocephalae 40g, Herba Cistanches 30g weigh respectively, clean, mix, and the determining alcohol adding 3kg is The ethanol of 80%, extracts after being heated to reflux 5 hours, filters, obtains the first filtrate;By filtering residue again with the determining alcohol of 1.6kg The ethanol of 80% dissolves, and extracts after being heated to reflux 3 hours, filters, obtains the second filtrate;Merge the first filtrate and second to filter Liquid, decompression recycling ethanol to be concentrated into liquor strength be 0.8g crude drug/mL, upper D101 macroporous adsorbent resin eluting, resin volume It it is 5 times of concentrated medicament volume, first with deionized water or the distilled water eluting of 7 times of resin column volumes, then with 5 times of resin column volumes Determining alcohol be 90% ethanol elution, collect ethanol elution, concentrating under reduced pressure remove ethanol, be dried and be ground into powder, to institute Obtaining and add water for injection in powder, crude drug corresponding in every 1000ml water for injection is 300g, and it is complete that slight fever promotes that powder dissolves, Standing overnight, 0.45 μm microporous filter membrane filters to obtain filtrate, and it is 6.5 that gained filtrate adds pH adjusting agent Fructus Citri Limoniae acid for adjusting pH, gained Solution sterilization, subpackage, both.
Toxicologic study
Select healthy KM mice 60, SPF level, male and female half and half, body weight 20 ± 2g.
The Chinese Traditional Medicine into Point liquid 1 of the embodiment of the present invention 1 preparation, is processed into containing crude drug 0.611g/ml, 1.7795g/ml Medicinal liquid, wherein high concentration injection carries out anxious toxicity test, employing low concentration injection carries out long term toxicity test in selection.
The dosage of table 1 mice and natural law
Lot number Dosage Administration time Be equivalent to adult human dose's multiple
1 12.22g/kg 7d+21d 57
3 35.59g/kg 7d 152
The each batch of mice is randomly divided into blank group, administration group, and female half and half, according to table 1, administration group dilutes respectively After the injection intramuscular injection of the present invention injection (simulation human acupoint injection) of various dose, 0.2ml/20g body weight, 2 times/ My god;Blank group gives normal saline intramuscular injection and injects, 0.2ml/20g body weight, 2 times/day.Wherein anxious toxicity test mice is administered 7d, long term toxicity test mice is administered 7+21d, altogether 28d, free diet, drinking-water.
After administration, observe general status and the death condition of mice every day, observation index: hair is the cleanest and the tidiest, glossy; Oral cavity is with or without secretions;Upper eyelid is the most sagging, and eyeball has atremia and highlights;With or without conjunctival congestion with shed tears;Whether activity Freely, the quickest to irritant reaction;With or without ataxia;Breathe the most normal;With or without abdomen gulf, abdominal distention, constipation, stool colour With or without change;With or without refusing to eat, the situation such as become thin;And record body weight change and the food-intake of mice every day.Respectively with laboratory observation Terminating to put to death mice in latter 1 day, whether its heart of anatomic observation, liver,spleen,kidney, thymus, brain have pathological change and weigh each internal organs Weight.
All experimental datas are all with mean scholar's standard deviationRepresent, use SPSS15.0 statistical software to add up, adopt Checking with t, P < 0.05 or P < 0.01 is statistically significant.
Result
The ordinary circumstance of mice after administration: during administration, none is dead, These parameters appearance the most without exception, mice spirit In order.
The impact that Mouse Weight is increased by medicine: the body weight of each concentration administration group increases compared with blank group.Body weight is the most aobvious Write and increase (P < 0.01).
The medicine impact on mice organs index
Main organs (heart, liver,spleen,kidney, thymus, the brain) visual color of each group mice is scarlet, smooth surface, not Find swelling, the abnormal change swum blood, turn white.The each batch of mice administration group compares with blank group, cardiac index, liver index, spleen index, Renal index, thymus index and cerebral index there are no significant difference (P > 0.05).
Discuss
Originally test result indicate that, there is not poisoning symptom and dead generation in mice after being administered, it is impossible to measure LD50, illustrate little Mus is at least the highest accumulation daily dose 35.59g/kg to the maximum tolerated dose of this product, is equivalent to 152 times of dosage for adults.Respectively Group mice daily inleting appetite is close, but the Mouse Weight of administration group increases very fast, compares statistically significant with blank group, and prompting should Prescription may also promote the effect of growth.Organ index is that internal organs are affected by reflection medicine, the especially important indicator of toxicity. Organ index increases expression internal organs the changes such as hyperemia, edema, hypertrophy, hypertrophy, and organ index declines expression internal organs atrophy, regression Property change etc., and liver, kidney are the main internal organs of Chinese materia medica tocixity effect.In anxious toxicity and long term toxicity test, give with mice not After the medicine of concentration, each main organs pathological changes the most without exception, each group mouse core index, liver index, spleen index, kidney Index, thymus index, cerebral index are close, through t inspection there are no significant difference, point out this injection of the present invention dirty without obvious whip Device toxic action, safety range is bigger.
Clinical observation
The pain caused for many osteopathia, we choose the most serious cancer bone metastasis patient and do clinical observation Research, if can confirm can there be preferable curative effect for cancerous pain, then the bone pain caused for other factors should be also There is preferable curative effect.
Clinical data
In Decembers, 2015~in March, 2016, we accept carcinous Bone tumour patient 98 example with osteodynia as clinical symptoms altogether for medical treatment, All cases are confirmed by pathology, image and bone scanning.Man's 47 examples, female 51 example;Age 39-63 year, average 55.1 years old;Protopathy 29 Cases of Lung Cancer, 22 cases of breast cancer, rectal cancer 15 example, 9 cases prostate cancer, gastric cancer 8 example, carcinoma of endometrium 8 example, hepatocarcinoma 8 example.At random Being divided into treatment group 55 example, radiation alone group 53 example, two groups of clinical datas compare and there was no significant difference.
Therapeutic Method
Tcm therapy treatment group
On the basis of conventional radiation therapy cancer, use the Chinese medicine preparation acupoint injection therapy liquid 1 of the embodiment of the present invention 1 preparation, With osteocarcinoma metastasis site local point selection and take SHENYU acupoint, after routine disinfection, every acupoint injection therapy 0.5ml, every day 1 time.
Radiation alone group
Two groups all with linear accelerator x-ray extracorporeal irradiation, 3 times a week, each 350cGy (tumor tissues amount), concurrent irradiation 4 In week, irradiate total amount 42Gy/12 time.
Observation index
1. Pain Grading (by patient main suit),
I level: painless;
II level: slight, though there being pain, but can stand, and sleep is interference-free, can orthobiosis;
III level: moderate, pain is obvious, it is impossible to stand, it is desirable to pain relieving, and sleep is disturbed;IV level: severe, has an intense pain, Seriously can be disturbed with autonomic nervous function performance or positive position, sleep;V level: extremely, it is the most serious that patient can state Pain.
2. Chinese medicine ZHITONG GAO and the untoward reaction of radiotherapy.
Efficacy assessment standard
Complete incidence graph (CR), part alleviation (PR), minor responses (MR), invalid (NR).
Statistical method uses
Use SPSS15.0 statistics software, data are carried out χ2Inspection, with P < 0.05 for there being significant difference.
Result
Two groups of comparitive study after treating 1 week
Table 2 treat 1 week after two groups of comparitive study
Two groups of curative effects through statistical procedures,*P < 0.05
Table 2 is it can be seen that the acupoint injection therapy liquid entirety pain effect using the present invention to provide substantially alleviates.
Two groups of comparitive study after treating 4 weeks
Table 3 treat 4 weeks after two groups of comparitive study
Group N CR PR MR NR Total effective rate %
Chinese drug-treated group 55 28 19 7 1 98.18*
Combination radiotherapy group 53 11 13 13 16 69.81
Two groups of curative effects through statistical procedures,*P < 0.05
Table 3 is it can be seen that the acupoint injection therapy liquid entirety pain effect using the present invention to provide substantially alleviates.
Untoward reaction
All someone occurs that radioactive skin reacts to two groups of patients, after dermatological department is held a consultation, the most specially treated, spontaneous recovery. Treatment group is without Chinese medicine anaphylaxis.
Conclusion
In sum, Chinese medicine preparation of the present invention has good pain relieving work for the cancerous pain that cancer bone metastasis causes With.
Comparative example 1 acupoint injection therapy liquid 2
Using preparation method same as in Example 1, medical material consumption is identical in addition to Herba speranskiae tuberculatae, the usage amount of Herba speranskiae tuberculatae For 10g.
Comparative example 2 acupoint injection therapy liquid 3
Using preparation method same as in Example 1, medical material consumption is identical in addition to Rhizoma Corydalis, the usage amount of Rhizoma Corydalis For 10g.
Experimentation
Materials and methods
Material
Laboratory animal
KM mice, SD rat, Japan large ear rabbit, male and female dual-purpose.
Instrument and reagent
Phenol red fasten extra large three Ai Si reagent company limiteies and produce;Oleum Terebinthinae is fastened perfumery, sea and is produced;Ammonia fastens seaization Work two factory produces;Dimethylbenzene (content > 99.0%) is that Solution on Chemical Reagents in Shanghai company of Chinese Medicine (group) company produces;Injection Fasten extra large four medicine company limiteies with ampicillin to produce.
Medical Equipment Plant of Jiading District in Shanghai City of laryngeal spray system produces;Frontal mirror is fastened Hai Yiyongtingzhenqichang and is produced;721 Spectrophotometer is fastened sea the 3rd analytical tool factory and is produced;Electronic balance is fastened Hai Tianpingyiqichang and is produced;Sea fastened by centrifuge Operating theater instruments factory produces;Olympus optical microscope is produced by Japan.
Medicine
The Chinese Traditional Medicine into Point liquid 1 of the embodiment of the present invention 1 preparation, the Chinese Traditional Medicine into Point liquid 2 of comparative example 1 preparation, compares The Chinese medicine injection 3 of example 2 preparation, being all processed into crude drug concentration is 1g/ml solution.
Aspirin, Shanghai nine good fortune pharmaceutcal corporation, Ltd produce, face the used time with distilled water be configured to 0.95% concentration supply Experiment is used.
Experimental technique
Antiinflammatory action is observed
KM mice auricle swelling Inhibition test
Select body weight 25 ± 3g mice, male and female dual-purpose, be randomly divided into 4 groups, often group 20.Matched group injecting normal saline, The Chinese Traditional Medicine into Point liquid 1 of the invention group injection embodiment of the present invention 1 preparation, compares the traditional Chinese medicine acupoint of 1 group of injection comparative example 1 preparation Injection 2, compares the Chinese Traditional Medicine into Point liquid 3 of 2 groups of injection comparative example 2 preparations, all injection 0.1ml/10g body weight, for three days on end. 1h after being administered for 4th day, in mouse right ear exterior feature positive and negative melted paraxylene 2, after 30min, dislocation of cervical vertebra puts to death mice, along auricle base Two ears cut by line, lay auricle (diameter 9mm) at same position card punch and weigh.Represent inflammatory with the difference of two auricle weight to swell Swollen degree, t inspection between organizing, and obtain the inhibitory rate of intumesce of each group as follows.
The average swelling of inhibitory rate of intumesce (%)=matched group-administration group average swelling of average swelling/matched group × 100%
Rat granuloma Inhibition test
Select body weight 300 ± 20gSD rat, random point 5 groups, respectively normal saline (NS) matched group, invention group, compare 1 group, compare 2 groups and aspirin (AS) group.Making abdominal incision under ether light anaesthesia aseptic condition, in both sides, groin is subcutaneous Each aseptic cotton balls 1 imbedding 30 ± 1mg, adds ampicillin 1mg/0.1ml with front each cotton balls, and 50 DEG C of baking ovens are done.Except Ah Si Woods group is that gastric infusion is outer (5mg/kg body weight), and remaining is respectively organized preoperative 1h and postoperative mc (intramuscular injection) and is administered, and all injects 0.1ml/10g body weight, continuous 7 days.Last is administered the neck that breaks of rat after 1h and puts to death, and peels off and takes out cotton balls granulation tissue, puts into 60 DEG C Oven drying 4h.Weigh after taking-up, deduct raw cotton ball weight and be granuloma dry weight.Calculate and relatively respectively organize average granuloma Weight/100g body weight.
Inhibitory action to arthralgia
Select body weight 300 ± 20gSD rat, random point 6 groups, respectively normal saline (NS) matched group, model control group, Invention group, compare 1 group, compare 2 groups and aspirin (AS) group.Under the conditions of ether light anaesthesia, rat left lower extremity is fixed on On self-making operational platform, vertical drop 30g counterweight, highly 40cm, causes closed fracture to rat left lower extremity, then left lower extremity flesh The Chinese Traditional Medicine into Point liquid 1 of the meat injection embodiment of the present invention 1 preparation, compares the Chinese Traditional Medicine into Point of 1 group of injection comparative example 1 preparation Liquid 2, compares the Chinese Traditional Medicine into Point liquid 3 of 2 groups of injection comparative example 2 preparations, all injection 0.1ml/10g body weight, and aspirin group is Gastric infusion (5mg/kg body weight), observes the writhing number of times that rat causes because of pain.
Result
The antiinflammatory action of Chinese medicine preparation of the present invention
The Chinese medicine preparation of the present invention impact on mice auricle swelling, is shown in Table 4.
The impact on mice auricle swelling of table 4 Chinese medicine preparation of the present invention
Group n Auricle swelling degree (mg) Inhibitory rate of intumesce (%)
Model control group 20 17.2±3.8 -
Invention group 20 7.9±1.9 54.07
Relatively 1 group 20 13.4±2.7 22.09*△
Relatively 2 groups 20 10.0±2.0 41.86
Compare with invention group,*P < 0.05, compares with matched group,P < 0.05
Observing on the mice auricle swelling model made of dimethylbenzene, Chinese medicine preparation of the present invention substantially suppresses mouse ear Wide swelling, its inhibitory rate of intumesce reaches 54.07%.Result shows, Chinese medicine preparation of the present invention can substantially resist caused by dimethylbenzene little Mus auricle inflammatory edema, when adding Herba speranskiae tuberculatae amount and being very few, anti-inflammatory effects substantially weakens.
The impact that rat granuloma is swollen by Chinese medicine preparation of the present invention, is shown in Table 5
The impact that rat granuloma is swollen by table 5 Chinese medicine preparation of the present invention
Compare with invention group,*P < 0.05, compares with aspirin group,P < 0.05
Observing on rat granuloma swells model, Chinese medicine preparation of the present invention substantially suppresses granuloma to grow, granuloma Suppression ratio exceedes aspirin group.
Impact on arthralgia rat model pain writhing response
The table 6 impact on arthralgia rat model pain writhing response
Group N Writhing number of times
Blank group 10 2.41±0.13
Model control group 10 19.41±5.13
Aspirin group 10 8.81±4.85*
Invention group 10 4.53±2.86*
Relatively 1 group 10 6.88±3.48*
Relatively 2 groups 10 15.10±4.58#△
Compare with blank group,#P < 0.05, compares with model group,*P < 0.01, compares with invention group,P < 0.05
On rat articular pain model, Chinese medicine preparation of the present invention is used substantially to have good analgesic effect, and if The usage amount of Rhizoma Corydalis is crossed and can be weakened analgesic effect at least.
Conclusion
By the experimentation of Chinese Traditional Medicine into Point liquid of the present invention, its have preferable antiinflammatory, ease pain, effect of subsiding a swelling, and Pass through safety evaluation, there is good clinical generalization value.
All above-mentioned primary these intellectual properties of enforcement, do not set this new product of enforcement limiting other forms And/or new method.Those skilled in the art will utilize this important information, and foregoing is revised, to realize similar execution feelings Condition.But, all modifications or transformation belong to the right of reservation based on new product of the present invention.
The above, be only presently preferred embodiments of the present invention, is not the restriction that the present invention makees other form, appoints What those skilled in the art changed possibly also with the technology contents of the disclosure above or be modified as equivalent variations etc. Effect embodiment.But every without departing from technical solution of the present invention content, the technical spirit of the foundation present invention is to above example institute Any simple modification, equivalent variations and the remodeling made, still falls within the protection domain of technical solution of the present invention.

Claims (5)

1. the agent that relieves the pain, it is characterised in that: crude drug include Radix Stephaniae Tetrandrae, Herba speranskiae tuberculatae, Rhizoma Corydalis, Fructus Evodiae, Oletum Trogopterori, Myrrha, Stichopus japonicus, Rhizoma Smilacis Glabrae, Concretio Silicea Bambusae, Lignum Pini Nodi, Radix Clematidis, Radix Angelicae Sinensis, the Radix Paeoniae Alba, Radix Glycyrrhizae, Borneolum Syntheticum, Rhizoma Curcumae, Semen Coicis, Rhizoma Atractylodis Macrocephalae and meat desert Rong.
Relieve the pain agent the most as claimed in claim 1, it is characterised in that: described Herba speranskiae tuberculatae: Radix Stephaniae Tetrandrae: the consumption quality of Rhizoma Corydalis three Ratio is 3: 1: 3.
Relieve the pain agent the most as claimed in claim 1 or 2, it is characterised in that: the weight portion of each crude drug is respectively Radix Stephaniae Tetrandrae 10 weight Part, Herba speranskiae tuberculatae 30 weight portion, Rhizoma Corydalis 30 weight portion, Fructus Evodiae 11 weight portion~13 weight portions, Oletum Trogopterori 14 weight portion~16 Weight portion, Myrrha 14 weight portion~16 weight portions, Stichopus japonicus 14 weight portion~16 weight portions, Rhizoma Smilacis Glabrae 29 weight portion~31 weight Part, Concretio Silicea Bambusae 9 weight portion~11 weight portions, Lignum Pini Nodi 9 weight portion~11 weight portions, Radix Clematidis 19 weight portion~21 weight portions, when Return 29 weight portions~31 weight portions, the Radix Paeoniae Alba 29 weight portion~31 weight portions, Radix Glycyrrhizae 19 weight portion~21 weight portions, Borneolum Syntheticum 9 weight Amount part~11 weight portions, Rhizoma Curcumae 14 weight portion~16 weight portions, Semen Coicis 29 weight portion~31 weight portions, Rhizoma Atractylodis Macrocephalae 39 weight portion ~41 weight portions, Herba Cistanches 29 weight portion~31 weight portions.
4. the agent that relieves the pain as described in claims 1 to 3, it is characterised in that: the weight portion of each crude drug is respectively Radix Stephaniae Tetrandrae 10 weight Part, Herba speranskiae tuberculatae 30 weight portion, Rhizoma Corydalis 30 weight portion, Fructus Evodiae 12 weight portion, Oletum Trogopterori 15 weight portion, Myrrha 15 weight portion, Stichopus japonicus 15 weight portion, Rhizoma Smilacis Glabrae 30 weight portion, Concretio Silicea Bambusae 10 weight portion, Lignum Pini Nodi 10 weight portion, Radix Clematidis 20 weight portion, Radix Angelicae Sinensis 30 Weight portion, the Radix Paeoniae Alba 30 weight portion, Radix Glycyrrhizae 20 weight portion, Borneolum Syntheticum 10 weight portion, Rhizoma Curcumae 15 weight portion, Semen Coicis 30 weight portion, Rhizoma Atractylodis Macrocephalae 40 weight portion, Herba Cistanches 30 weight portion.
5. relieve the pain as described in Claims 1-4 the preparation method of agent, it is characterised in that including:
The first step, weighs respectively by each crude drug component, cleans, mixes by described weight portion, adds relative to acquisition The ethanol that determining alcohol is 80% of 6~8 times of mixture quality, extract after being heated to reflux 5 hours, filter, obtain the first filtration Liquid;Filtering residue is dissolved with the ethanol of the determining alcohol 80% of 4 times of the mixture quality relative to acquisition again, is heated to reflux 3 little Extract time after, filter, obtain the second filtrate;Merging the first filtrate and the second filtrate, decompression recycling ethanol is also concentrated into medicine Liquid concentration is 0.8g crude drug/mL, and upper D101 macroporous adsorbent resin eluting, resin volume is 5 times of concentrated medicament volume, first with 7 The deionized water of times resin column volume or distilled water eluting, then be 90% ethanol elution with the determining alcohol of 5 times of resin column volumes, receive Collection ethanol elution, concentrating under reduced pressure removes ethanol, is dried and is ground into powder;
Second step, adds water for injection in first step gained powder, and crude drug corresponding in every 1000ml water for injection is 300g, Slight fever promotes that powder dissolves completely, stands overnight, and 0.45 μm microporous filter membrane filters to obtain filtrate, and gained filtrate adds pH adjusting agent lemon Lemon acid for adjusting pH is 6.2~6.8, gained solution sterilization, subpackage, both.
CN201610602412.1A 2016-07-25 2016-07-25 Analgesic and preparation method thereof CN106039232A (en)

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CN101385843A (en) * 2008-10-21 2009-03-18 刘少敏 Nano medicine magnet therapy plaster for relieving the swelling and easing pain
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CN104000688A (en) * 2014-06-16 2014-08-27 王跃进 Interactive pain relieving pasting medicine matched with magnetic snap
CN105709169A (en) * 2014-12-02 2016-06-29 徐利华 Ointment for treating wind-damp pain of neck, shoulders, waist and legs

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101385843A (en) * 2008-10-21 2009-03-18 刘少敏 Nano medicine magnet therapy plaster for relieving the swelling and easing pain
CN101954053A (en) * 2010-10-28 2011-01-26 吴保玉 Traditional Chinese medicinal patch and preparation method thereof
CN102091295A (en) * 2011-01-17 2011-06-15 赵献民 Chinese medicinal composition for treating femoral head necrosis and preparation method thereof
CN102580000A (en) * 2012-03-21 2012-07-18 山东省千佛山医院 Medicament for curing cancer pain and preparation method thereof
CN103830677A (en) * 2014-03-12 2014-06-04 河南中医学院 Traditional Chinese medicine paste for treating cancer pain
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Application publication date: 20161026