CN102274460B

CN102274460B - Tibetan medicine aerosol for treating acute and chronic sprain/contusion, rheumatism and rheumatoid disease

Info

Publication number: CN102274460B
Application number: CN2011102213456A
Authority: CN
Inventors: 李晓强; 刘渊宏
Original assignee: Gansu Qizheng Tibetan Medicine Co Ltd
Current assignee: Gansu Qizheng Tibetan Medicine Co Ltd
Priority date: 2009-01-21
Filing date: 2009-06-01
Publication date: 2013-03-06
Anticipated expiration: 2029-06-01
Also published as: CN101574505A; CN102274460A

Abstract

The invention discloses a medicine composition aerosol for treating acute and chronic sprain/contusion, rheumatism and rheumatoid disease, which is prepared from the following active pharmaceutical ingredients: lamiophlomis rotata, whin, curcuma, pepper, buffalo horn, Myricaria germanica, safflower, borneol and the like. The medicine composition disclosed by the invention has the effects of activating blood circulation to dissipate blood stasis, promoting the subsidence of swelling and alleviating pain. The composition aerosol disclosed by the invention has the characteristics of advanced preparation formulation, simple technique, quick effect taking and the like.

Description

A kind of Tibetan medicine aerosol for the treatment of acute and chronic bruise, rheumatism, rheumatoid disease

Technical field

The present invention relates to a kind of Tibetan medicinal composition and preparation method thereof, particularly a kind of Tibetan medicine aerosol for the treatment of acute and chronic bruise, rheumatism, rheumatoid disease, the application is dividing an application of No. 200910143877.5 patent application.

Background technology

Tibetan medicine is with a long history.The compatriot of Tibetan who lives in the Qinghai-Tibet Platean has progressively formed exclusive treatment theory and method in the struggle of the Nature.The compatriot of Tibetan is one of traditional nomadic people, because living environment is abominable, bruise, rheumatic and rheumatoid arthritis person are more, has ailingly brought endless misery to them, and rheumatic and rheumatoid arthritis is unspeakable especially to the pain that the mankind bring.The Tibetan medicine often can make pain relief and healing by the external treatment means through long-term practice and summary, and this has proved absolutely the unique charm of Tibetan medicine and pharmacology theoretical system.

Theoretical according to the Tibetan medicine, three large factors (dragon, red bar, Baconic) keep balance, and the human physiological functions activity is kept normally.Will cause three factor disequilibriums if one of three large factors suffer to destroy (partially contain or partially decline), human physiological functions is diseases then.The limbs such as bruise, traumatic injury stasis of blood pain are injured, and rheumatism, rheumatoid, scapulohumeral periarthritis etc. are all because of soft tissue injury, and grain is injured, and blood circulation is obstructed, and causes congestion and swelling pain.This is because " dragon " suffers to destroy (annotating: " dragon " main breathing, limb activity, blood circulation), causes three large factor disequilibriums.To hold up " dragon " to controlling principle.

In the Four-Volume Medical Code (eightth century of Christian era), " Jingzhubencao " (18th century of Christian era) these two Tibetan medicine and pharmacology masterpieces all respectively among the other side single medicine record relaxing muscles and tendons and activating QI and blood in the collateral, bone-setting pain stopping, hesitant pulse hemostasis, wind-damp dispelling pain relieving, the effect of yellow fluid reducing.And confirmed by modern medicine and pharmacology, and matched with the contained effect of state-promulgated pharmacopoeia and Tibetan medicine standard promulgated by the ministries or commissions of the Central Government, also in state-promulgated pharmacopoeia and Tibetan medicine standard promulgated by the ministries or commissions of the Central Government, recorded.

" muscle and tendon injury " is the name of disease of the traditional Chinese medical science, the joint at each position of ordinary person's body, grain, muscle, fascia, tendon, ligament etc., be subjected to that external violence bump, brute force are reversed, tractive, compressing or because of accidentally tumbling down, sprain and contusion, or body empty, overwork and persistent movement, the prolonged reason such as be overworked for a very long period, caused function or textural anomaly, and be called muscle and tendon injury without fracture, dislocation or skin injury person.Motherland's medical science has very abundant document record to diagnosis and the treatment of muscle and tendon injury." Plain Questions. five hide a generation piece of writing " record " all muscle persons all belong to the joint ".The muscles and bones joint is powerful sliding sharp, and motion mainly relies the effect in QI and blood flexibly.Write " feet with sufficient blood can walk normally, the palm with sufficient blood can grip tightly refer to be subjected to blood and can pinch " in the book." this Tibetan of Ling Shu Miraculous Pivot or Divine Axis " record: " ... blood and then passages through which vital energy circulates is popular, the multiple negative and positive of battalion, muscles and bones is powerful, the clear profit in joint." " Yizong Jinjian bonesetting heart method main idea. the treatment by oral administration of medicines demonstration of mixing " point out that " specialty of bone setting of the present, namely the card of ancient traumatic injury also specially from the blood opinion, must be distinguished first or have congestion to stop amassing, or be that exhaustion of blood is too much, then imposes the method for the treatment of by oral administration of medicines, and is multitudinous also not wrong." as seen motherland's medical science is early on the books to damaging all diseases, and arranged dividing of " blood stasis " " exhaustion of blood "." blood stasis " refers to that hemorrhage is detained in the body; " exhaustion of blood " refers to that blood oozing from the body openings or subcuta neous tissue is in external.Closed injury belongs to the congestion stagnation more clinically, and open injury belongs to " exhaustion of blood " more but gas and blood are all human life activity's power and source, qi as the commander of blood, blood is capable with gas, gas hemopoietic, promoting the circulation of blood, take the photograph blood, blood being the mother of qi, and physiological pathology of human body changes and invariably relates to QI and blood.If receive damage, must injure QI and blood, cause stagnation of QI and blood or blood oozing from the body openings or subcuta neous tissue.Generally speaking, blood is hindered then swelling, and impairment of QI is pain then.Mostly clinically is impairment of both QI and blood, swells and ache and deposits, or pain after swollen first, or swell and ache and existing.

Modern medicine is thought: human body soft tissue is to be made of motor system soft tissues such as skeletal muscle, fascia, ligament, joint capsule, periosteum, fatty tissuees.Soft tissue injury comprises acute injury and chronic injury.Acute injury is often caused local damage, hemorrhage, edema, muscle spasm or muscle dislocation to be caused by wound factors such as spraining, dampen, pull.Chronic injury is a kind of infringement.Caused by aseptic inflammation.Acute soft tissue injury shows as: body a part is disposable to be subject to larger External Force Acting, causes local organization, cell, little blood vessel to suffer destruction in various degree, can follow tear, fracture, hemorrhage, organize hematoma; After the stopped bleeding, the product with slough decomposes causes the expansion of local little blood vessel, hyperemia, and vascular permeability increases, and protein, leukocyte ooze out, and form the damaging obstruction of lymphatic vessel, and transudate can not be transported; Have red, swollen, hot, the pain and dysfunction.Chronic injury then is because dealing with improperly of acute injury is transformed into chronic injury.Also can cause the accumulation of trickle damage, and finally cause strain because the local organization long-term load is overweight, the traumatic condition slower development, symptom is not obvious, and tissue repair is difficulty.According to the traumatic condition evolution, be divided into early stage, mid-term, later stage.In early days, because tissue metabolism's disequilibrium, the degeneration variation has occured in the chemical constitution of the sugar in the tissue, lipoid, protein, but there is no obvious change in the morphology, also without bad sensation, only there is aching and tired sense the part, often out in the cold, if can in time alleviate local burden, improve blood circulation and metabolism status, damage is unlikely development, and can very fast rehabilitation.In mid-term, because localised load does not improve yet, organizational structure is damaged for a long time, the cytotrophy imbalance causes hamartoplasia, degeneration, sour swollen, the pain of affected part, after the movable open, sx↓ or disappearance occur again after the motion, can find the clinical manifestations such as tissue elasticity weakens, hardens, thickening.In the later stage, the little blood vessel wall generation in traumatic part lipoid sample becomes, vessel wall thickening, and tube chamber narrows down, and blood flow reduces, cause the traumatic part ischemia, severe patient vascularization thrombosis, blocking blood flow causes tissue ischemia downright bad, the patient is swollen except traumatic part acid, and outside pain increased the weight of, it was cool, insensitive etc. also can to cause the part to send out.

Stiff neck many during because of sleep medicated pillow too high, low, really up to the mark or sleeping position is bad with excessivelying, make musculi colli be subject to for a long time tractive and be in the hypertonicity state and firm static occurs and damage.To involve a side soft tissue as main.Neck pain appears after disease opinion is wakeeed up, askew to Ipsilateral, movable unfavorable, especially look back as very with rotation, pain can be to the shoulder back of the body, the district's radiation of shoulder foot, the musculi colli tenderness, touch such as strip or bulk.Or because cervical region reverses suddenly or weight pickaback, cause cervical region part muscle sprain, occur due to the twin and swelling of convulsion.The patient has the acute injury history more, and disease is seen the rear cervical pain of wound, and the sense of heavy burden being arranged, and pain can be radiated to the shoulder back, and restriction of neck motion can be touched muscle spasm at sore spot, local mild swelling and tenderness.

Shoulder joint is the joint that activity direction is maximum and amplitude is maximum in the whole body joint, and its joint capsule is more lax, and the most of strength by periarticular muscle, flesh key and ligament of the stability in joint is kept.Because the blood supply of flesh key itself is relatively poor, and with advancing age degenerative change occurs, shoulder joint Comparison of Gardening Activities in life is frequent in addition, and surrounding soft tissue often is subject to from the friction of each side and extruding, so chronic strain easily occurs.

In addition, shoulder joint various weigh wounded, pull, sprain, contusion etc. all can make shoulder muscle, the fracture of ligament generating portion, and be hemorrhage between tissue.Break at and produce cicatrix, adhesion, hemorrhage, aseptic inflammation etc. in the repair process, the shoulder joint kinesitherapy dysfunction occurs at last.Suffer from cold also is one of its paathogenic factor.Hyperosteogeny is the degeneration that is mainly in neck, breast, lumbar vertebra.Human synovial and near soft tissue and blood vessel can wear out gradually to a dating, occur to dissect and physiological variation, and damaged engenders osteophytosis and Subchondral bone sclerosis during owing to daily routines.Hyperosteogeny belongs to the category of motherland's medical science " rheumatism involving the bone ", owing to the middle-aged and elderly people QI and blood is gradually lost, and deficiency of the liver and kindey, wind-cold damp pathogen is taken advantage of a weak point in opponent's defence and the people, evil resistance joint, the QI and blood paralysis stagnates, and blockage of main and collateral channels is so primary disease take pain as main, is helped with numbness and limitation of activity.

Pain does not occur in normal spinal column under quiet with moving state, when spinal column itself or its surrounding tissue have been subject to stimulating or have damaged, just pain can occur, and can affect its function thereupon.All stress that is not suitable for the spinal column physiological requirement, all may produce spinal column and waist stimulates or damage comprises strain).Static strain can be described as the posture strain, dynamicly can be described as mobility strain.Trunk is when bearing a heavy burden with activity, and the position is lower, and its weight of bearing is larger, so waist stress is maximum.The main spinal column itself and ligament on every side and muscle thereof of leaning on of the stability of trunk kept.The work of for example bending over for a long time, waist muscle continues to be tense situation, and lumbar muscle strain can occur.Same some people sits office for a long time, although physical load is not heavy, because posture is bad, lacks again suitable activity, and there is a great strain on the muscles to cause a part, and day forms the strain of this part muscle long afterwards.Part patient also can betide malpractice behind the acute waist injury, delays into chronic lumbar muscle strain.Acute and chronic bruise, traumatic injury stasis of blood pain, stiff neck, lumbar muscle strain, old injury and pain all can be called soft tissue injury according to the division of modern medicine.The acute jerk contused wound traditional Chinese medical science is called acute muscle and tendon injury.Motherland's traditional medicine is to the systematic division of muscle and tendon injury.Therapeutic Principle to muscle and tendon injury initial stage and mid-term is the blood stasis dispelling detumescent, regulating QI to relieve pain.Mainly with the pain relieving of external repercussive, plaster or the liniment of the easypro warp of invigorating blood circulation are main.Modern medicine to the Therapeutic Method of acute soft tissue injury is: after spraining, pulling, implement local cold compress, the in-house blood capillary in injury is shunk, reduce internal hemorrhage and swelling reaction, reduce tissue temperature, play hemostasis, detumescence, analgesic effect, also can cooperate the oral administration and externally blood circulation promoting and blood stasis dispelling simultaneously, the reducing swelling and alleviating pain medicine.After injured 48 hours, wound site tissue reaction peak period is mistake, and the in-house blood stasis that at this moment wants help, edema disappear as early as possible.Hot compress and the blood circulation promoting and blood stasis dispelling, the reducing swelling and alleviating pain medicine that are equipped with oral administration and externally can improve blood and lymph fluid circulation, be conducive to the absorption of injury congestion and transudate: telangiectasis, promote local blood circulation, blood stasis, the absorption of edema of injury will be remained in, acceleration swelling is disappeared, oral administration and externally blood-activating stasis-removing kind medicine can promote the reparation of damaged tissue simultaneously.

The invention provides a kind of blood circulation promoting and blood stasis dispelling that has, the Tibetan medicine of the effect of reducing swelling and alleviating pain.Be used for acute and chronic bruise, traumatic injury stasis of blood pain, hyperosteogeny, rheumatism and rheumatoid pain, stiff neck, scapulohumeral periarthritis, lumbar muscle strain and old injury and pain.

Summary of the invention

One object of the present invention is to disclose a kind of pharmaceutical composition aerosol with blood circulation promoting and blood stasis dispelling, reducing swelling and alleviating pain treatment acute and chronic bruise, rheumatism, rheumatoid disease.

Another object of the present invention is to disclose a kind of blood circulation promoting and blood stasis dispelling that has, the production of aerosol of the pharmaceutical composition of reducing swelling and alleviating pain treatment acute and chronic bruise, rheumatism, rheumatoid disease.

The present invention seeks to be achieved through the following technical solutions:

A kind of pharmaceutical composition aerosol for the treatment of acute and chronic bruise, rheumatism, rheumatoid disease, its crude drug consists of:

Radix Lamiophlomidis Rotatae 5-15 weight portion, Herba Oxytropis Kansuensis 2-10 weight portion, Rhizoma Curcumae Longae 15-60 weight portion, Pericarpium Zanthoxyli 7-20 weight portion, Cornu Bubali 5-15 weight portion, Cacumen Myricariae Germanicae 15-40 weight portion, Flos Carthami 0.1-2.5 weight portion, Borneolum Syntheticum 0.1-5 weight portion, Camphora 0.1-5 weight portion.

Adjuvant consists of:

Polyvidone 1-10 weight portion, glycerol 0.5-5 weight portion, solubilizing agent 0-30 weight portion, propellant 20-100 weight portion.

Described solubilizing agent refers to tween, Myrij, paregal O, one or more among the peregal A;

Described propellant refers to one or more in Compressed Gas, propane, normal butane, iso-butane, pentane, tetrafluoroethane and the heptafluoro-propane.

The pharmaceutical composition aerosol of above-mentioned treatment acute and chronic bruise, rheumatism, rheumatoid disease, its crude drug composition is preferably:

Radix Lamiophlomidis Rotatae 10 weight portions, Herba Oxytropis Kansuensis 5 weight portions, Rhizoma Curcumae Longae 30 weight portions, Pericarpium Zanthoxyli 15 weight portions, Cornu Bubali 10 weight portions, Cacumen Myricariae Germanicae 30 weight portions, Flos Carthami 1 weight portion, Borneolum Syntheticum 1 weight portion, Camphora 1 weight portion.

Radix Lamiophlomidis Rotatae 12 weight portions, Herba Oxytropis Kansuensis 4 weight portions, Rhizoma Curcumae Longae 20 weight portions, Pericarpium Zanthoxyli 10 weight portions, Cornu Bubali 11 weight portions, Cacumen Myricariae Germanicae 25 weight portions, Flos Carthami 1.5 weight portions, Borneolum Syntheticum 1.5 weight portions, Camphora 2 weight portions.

Radix Lamiophlomidis Rotatae 7 weight portions, Herba Oxytropis Kansuensis 6 weight portions, Rhizoma Curcumae Longae 20 weight portions, Pericarpium Zanthoxyli 15 weight portions, Cornu Bubali 8 weight portions, Cacumen Myricariae Germanicae 25 weight portions, Flos Carthami 1.5 weight portions, Borneolum Syntheticum 1.5 weight portions, Camphora 2 weight portions.

Polyvidone 6 weight portions, glycerol 2 weight portions, tween 80 9 weight portions, tetrafluoroethane 90 weight portions.

Above-mentioned aerosol adjuvant is more preferably:

Polyvidone 3 weight portions, glycerol 3 weight portions, tween 80 40 weight portions, tetrafluoroethane 30 weight portions.

Above-mentioned aerosol adjuvant is more preferably:

Polyvidone 7 weight portions, glycerol 1.5 weight portions, tween 80 20 weight portions, tetrafluoroethane 50 weight portions.

Above-mentioned aerosol adjuvant is more preferably:

Polyvidone 9 weight portions, glycerol 4.5 weight portions, tetrafluoroethane 60 weight portions.

The invention provides a kind of preparation method of the pharmaceutical composition aerosol of above-mentioned treatment acute and chronic bruise, rheumatism, rheumatoid disease:

Radix Lamiophlomidis Rotatae, Herba Oxytropis Kansuensis, Rhizoma Curcumae Longae, Pericarpium Zanthoxyli, Cornu Bubali, Cacumen Myricariae Germanicae, Flos Carthami are added 40-90% alcohol reflux 1-4 time, and each 0.1-3 hour, the each 5-15 of quantity of solvent times, collecting decoction filters, and is condensed into the clear paste of 1.00-1.35 (60 ℃), and was for subsequent use; Borneolum Syntheticum, Camphora, glycerol, solubilizing agent, polyvidone 40-90% dissolve with ethanol, for subsequent use; Mentioned solution and clear paste are merged, add ethanol and make and contain the alcohol amount and be 40-85%, mixing leaves standstill, and filters, fill, and sealing is filled with propellant and get final product.

Preferably:

Radix Lamiophlomidis Rotatae, Herba Oxytropis Kansuensis, Rhizoma Curcumae Longae, Pericarpium Zanthoxyli, Cornu Bubali, Cacumen Myricariae Germanicae, Flos Carthami are added 40-90% alcohol reflux 1-4 time, and each 0.1-3 hour, the each 5-15 of quantity of solvent times, collecting decoction filters, and is condensed into the clear paste of 1.00-1.35 (60 ℃), and was for subsequent use; Borneolum Syntheticum, Camphora, glycerol, solubilizing agent, polyvidone 40-90% dissolve with ethanol, for subsequent use; Mentioned solution and clear paste are merged, add ethanol and make and contain the alcohol amount and be 40-85%, mixing leaves standstill, and filters, and gets 150-600 parts by volume medicinal liquid, fill, and sealing is filled with 30-120 weight portion propellant and get final product.

Best:

Radix Lamiophlomidis Rotatae, Herba Oxytropis Kansuensis, Rhizoma Curcumae Longae, Pericarpium Zanthoxyli, Cornu Bubali, Cacumen Myricariae Germanicae, Flos Carthami are added 40-90% alcohol reflux 1-4 time, and each 0.1-3 hour, the each 5-15 of quantity of solvent times, collecting decoction filters, and is condensed into the clear paste of 1.00-1.35 (60 ℃), and was for subsequent use; Borneolum Syntheticum, Camphora, glycerol, solubilizing agent, polyvidone 40-90% dissolve with ethanol, for subsequent use; Mentioned solution and clear paste are merged, add ethanol and make and contain the alcohol amount and be 40-85%, mixing leaves standstill, and filters, and gets 300 parts by volume medicinal liquids, fill, and sealing is filled with 82.5 weight portion propellant and get final product.

The invention provides the second preparation method of the pharmaceutical composition aerosol for the treatment of acute and chronic bruise, rheumatism, rheumatoid disease:

Radix Lamiophlomidis Rotatae, Herba Oxytropis Kansuensis, Rhizoma Curcumae Longae, Pericarpium Zanthoxyli, Cornu Bubali, Cacumen Myricariae Germanicae, Flos Carthami were added the 40-90% soak with ethanol 5-72 hour, with adding 2-15 times of medical material weight of 40-90% ethanol, the 1-5ml/kgmin percolation is collected percolate, be condensed into the clear paste of 1.00-1.35 (60 ℃), for subsequent use; Borneolum Syntheticum, Camphora, glycerol, solubilizing agent, polyvidone 40-90% dissolve with ethanol, for subsequent use; Mentioned solution and clear paste are merged, add ethanol and make and contain the alcohol amount and be 40-85%, mixing leaves standstill, and filters, fill, and sealing is filled with propellant and get final product.

Preferably:

Radix Lamiophlomidis Rotatae, Herba Oxytropis Kansuensis, Rhizoma Curcumae Longae, Pericarpium Zanthoxyli, Cornu Bubali, Cacumen Myricariae Germanicae, Flos Carthami were added the 40-90% soak with ethanol 5-72 hour, with adding 2-15 times of medical material weight of 40-90% ethanol, the 1-5ml/kgmin percolation is collected percolate, be condensed into the clear paste of 1.00-1.35 (60 ℃), for subsequent use; Borneolum Syntheticum, Camphora, glycerol, solubilizing agent, polyvidone 40-90% dissolve with ethanol, for subsequent use; Mentioned solution and clear paste are merged, add ethanol and make and contain the alcohol amount and be 40-85%, mixing leaves standstill, and filters, and gets 150-600 parts by volume medicinal liquid, fill, and sealing is filled with 30-120 weight portion propellant and get final product.

Best:

Radix Lamiophlomidis Rotatae, Herba Oxytropis Kansuensis, Rhizoma Curcumae Longae, Pericarpium Zanthoxyli, Cornu Bubali, Cacumen Myricariae Germanicae, Flos Carthami were added the 40-90% soak with ethanol 5-72 hour, with adding 2-15 times of medical material weight of 40-90% ethanol, the 1-5ml/kgmin percolation is collected percolate, be condensed into the clear paste of 1.00-1.35 (60 ℃), for subsequent use; Borneolum Syntheticum, Camphora, glycerol, solubilizing agent, polyvidone 40-90% dissolve with ethanol, for subsequent use; Mentioned solution and clear paste are merged, add ethanol and make and contain the alcohol amount and be 40-85%, mixing leaves standstill, and filters, and gets 300 parts by volume medicinal liquids, fill, and sealing is filled with 82.5 weight portion propellant and get final product.

Pharmaceutical composition of the present invention has blood circulation promoting and blood stasis dispelling, the effect of reducing swelling and alleviating pain.Be used for acute and chronic bruise, traumatic injury stasis of blood pain, hyperosteogeny, rheumatism and rheumatoid pain, stiff neck, scapulohumeral periarthritis, lumbar muscle strain and old injury and pain.This invention medicament composing prescription be the doctor among the people of Tibetan according to the record of the Four-Volume Medical Code, " Jingzhubencao " two books, and form in conjunction with the practical experience prescription.The wild high-quality authentic medicinal herbs of pure natural is produced in raw materials used medicine polyphyly Qinghai-Tibet Platean, concocts according to the Tibetan medicine theory provision.According to Tibetan medicine, theory of Chinese medical science, the medicine with effect of reducing swelling and alleviating pain, blood circulation promoting and blood stasis dispelling is main (monarch) medicine.Wind-damp dispelling, yellow fluid reducing are followed successively by ministerial drug and adjuvant drug.Radix Lamiophlomidis Rotatae, Herba Oxytropis Kansuensis, Rhizoma Curcumae Longae are acute and chronic pain in the side, and the monarch drug of traumatic injury stasis of blood pain all has reducing swelling and alleviating pain, the effect of blood circulation promoting and blood stasis dispelling; Pericarpium Zanthoxyli, Cornu Bubali are ministerial drug, have easypro the meridian dredging, and the effect of wind-damp dispelling, yellow fluid reducing, pain relieving with the monarch drug compatibility, had both been brought into play the effect of self, had strengthened again the effect of monarch drug.Again the good medicine of wind-damp dispelling, yellow fluid reducing, clearing away heat from blood in view of Cacumen Myricariae Germanicae, the Flos Carthami promoting blood circulation to remove obstruction in the collateral, eliminating stasis to stop pain, treatment rheumatism, rheumatoid adjuvant drug, Borneolum Syntheticum, Camphora have the refreshment of having one's ideas straightened out, clearing away heat to alleviate pain, two medicines suffering, perfume (or spice) are walked to alter simultaneously, have stronger Transdermal absorption effect, and all medicine compatibilities more can strengthen it to controlling the curative effect of above-mentioned all diseases.

The present composition has the effect of better improvement to acute jerk contused wound, the acute jerk contused wound initial stage can be played the effect of ice compress physical therapy: the in-house blood capillary in injury shrinks, internal hemorrhage and swelling reaction reduce, can play detumescence, analgesic effect to the initial stage damage that bruise causes, be conducive to promote the reparation of wounded tissue.Prove by effect experiment:

1, medicine of the present invention has the effect of antagonism soft tissue injury, in the treatment of rat skin ecchymosis, can significantly accelerate dissipation and the improvement of the dermal ecchymosis; In the treatment to the rat traumatic soft tissue injury, can obviously improve and hinder the limb degree of injury, alleviate the pathological changes such as wound local organization blood stasis, swelling and cell infiltration;

2, medicine of the present invention has obvious antiinflammatory action, to Oleum Tiglii cause mice ear, carrageenin causes rat paw edema that significant inhibitory action is arranged;

3, medicine of the present invention has preferably analgesic activity, and the pain reaction that mice thermostimulation tail-flick method and acetic acid twisting method are caused has significant inhibitory action;

4, medicine of the present invention has the effect of blood circulation promoting and blood stasis dispelling, can significantly reduce the heat sink protein content of hemorheology sexual disorders rat, and (different animal pattern) plasma viscosity or whole blood viscosity are descended, the abdominal cavity capillary permeability raises inhibitory action is all arranged due to the Dichlorodiphenyl Acetate.

The present invention has the dosage form advanced person, and simple process acts on the characteristics such as rapid.Propellant in the aerosol has obvious refrigeration, on the basis that guarantees curative effect, has promoted product quality, has enlarged beneficiaries, and the employing of novel form, new adjuvant, new technology makes product quality safer, stable, controlled.

Following embodiment is all be used to further specifying but not as the restriction of the scope of the invention." this described in the following experimental example

The invention medicine " be the medicine of embodiment 3 preparations.

The effect of experimental example 1 anti-soft tissue injury

1. clamp is caused the therapeutical effect of rat skin ecchymosis

1.1 material

Animal: the SD rat, the cleaning level, male, body weight 190～210g is provided by Inst. of Genetics and Development Biology, CAS's animal center.The quality certification number: SCXK (capital) 2002-0006.

Medicine and reagent: medicine of the present invention; Blank substrate provides by Gansu Qizheng Tibetan Medicine Co., Ltd; Diclofenac, Novartis Pharma AG produces.

1.2 method

The back part of animal depilation cuts off first long hair with rat back, repastes an amount of depilatory (20% barium sulfide) and uses warm water cleaning after 3-4 minute, the about 5cm * 6cm of depilation area.With tiger clamp rat depilation district skin, to cause subcutaneous hemorrhage as degree, area is 4cm * 3cm behind the 24h.After 60 rat modelings, be divided at random model control group (to substrate), positive drug diclofenac group (12mg/kg), medicine of the present invention high (2.4g crude drug/kg), in (1.2g crude drug/kg), low dose group (0.6g crude drug/kg).12h begins percutaneous dosing after the modeling, and medicine is coated rat depilation zone, cover with thin film when needing and with adhesive tape ring around fixing, successive administration 5 days, every day 1 time.During the administration, often use the electric knives unhairing, in case of necessity again with depilatory depilation (following other percutaneous dosing test depilating methods are the same).By touching and swelling and the ecchymosis situation that disappears is estimated in perusal, and measure residue ecchymosis area during the every day administration, according to the form below is scored, and take total points as its ecchymosis severity, the result organizes a t and checks.

The setting of dosage:

Clinical plan dosage is: every day per kilogram people consumption: 2.7g ÷ 60kg=0.045g (crude drug)/kg.

Convert with body weight:

The quite clinical plan of rat, high dose is 2.4g (crude drug)/kg with 53.3 times of dosage; The quite clinical plan of middle dosage is 1.2g (crude drug)/kg with 26.6 times of dosage; The quite clinical plan of low dosage is 0.6g (crude drug)/kg with 13.3 times of dosage.

Convert with body surface area:

The quite clinical plan of rat, high dose is with 8.3 times of dosage, and the quite clinical plan of middle dosage is with 4.15 times of dosage, and the quite clinical plan of low dosage is with 2.1 times of dosage.

[high dose: 2.7g (crude drug) ÷ 56 (coefficient) ÷ 0.2=0.241g (crude drug)/kg, 2g (crude drug)/kg ÷ 0.241=8.3 (doubly)]

The Traumatic ecchymosis standards of grading

1.3 result

Medicine of the present invention is high, middle dosage (treatment to the rat skin ecchymosis in the 1st day～the 5th day after administration of 2.4g crude drug/kg, 1.2g crude drug/kg) have positive effect (with model group relatively, P＜0.05, P＜0.01); (the 2nd day～the 5th day the time, the dermal ecchymosis is compared also be significantly improved (P＜0.05) to medicine low dosage of the present invention with model group after administration for 0.6g crude drug/kg).The results are shown in Table 1.

Table 1 is on the impact of Rat Models of Traumatic ecchymosis

Annotate: compare with model group, ^*P＜0.05, ^*P＜0.01

2. cause the therapeutical effect of rat soft tissue injury to wounding device

2.1 material

Animal: the SD rat, the cleaning level, male, body weight 190～210g, section provides by Department Of Medicine, Peking University's Laboratory Animal Science.The quality certification number: SCXK (capital) 2002-0001.

Medicine, reagent and instrument: medicine of the present invention; Blank substrate provides by Gansu Qizheng Tibetan Medicine Co., Ltd; Diclofenac, Novartis Pharma AG produces.

Medicine of the present invention (4.28g crude drug/g), provided by Gansu Qizheng Tibetan Medicine Co., Ltd; Diclofenac, Novartis Pharma AG; Formaldehyde: Xu Dong chemical plant, Beijing produces, and it is for subsequent use to be made into 10% concentration; Ethanol: the Beijing Chemical Plant produces, and it is for subsequent use to be made into 60%, 70%, 80%, 95%, 100% concentration; Dimethylbenzene: the Beijing Chemical Plant produces; Hematoxylin: Beijing chemical reagents corporation produces; Yihong (eosin): the Beijing Chemical Plant produces; Both respectively are made into dye liquor and do HE dyeing; 56 ℃-58 ℃ of paraffin waxs: Shanghai China Ling Kangfuqixiechang produces; Resinene glue: Shanghai Sample Model Factory produces.

Automatic dehydrator, Japanese Sakura; Microtome, German Leitz; Automatic staining machine RAH-100, Japanese Sskura; Optical microscope, Japanese Nikon; Auto photographing biological microscope BH-2, Japanese Olympus; The auto photographing biological microscope, German Leica DMLK-HC; Wound device, this institute hemorheology laboratory is developed voluntarily.

2.2 method

Slough rat one side calf Mus hair with 20% barium sulfide first, [freely fall with weight and to wound the rat leg muscle with wounding device behind the 24h, Height Adjustable, potential energy transfers to 0.18kgm (quality * weight of potential energy=weight is to the height of limbs)] impact once in the mid calf outside, cause the local soft tissue damage, take " the not broken and interior damage of skin " as degree, if merging skin injury or fracture rat are rejected.60 of the rats of selection modeling success, be divided at random 6 groups, be model control group (to substrate), medicine height of the present invention (the 2.4g crude drug/kg), in (the 1.2g crude drug/kg), low dosage (0.6g crude drug/kg) organize, positive drug diclofenac (12mg/kg) group, be percutaneous dosing, successive administration 5 days, every day 1 time.During the administration, observe the performance such as the disease of hindering limb swelling and ecchymosis every day, and rank scores record damage index.Standards of grading are as follows:

0 minute: recovered fully the damage part, with normal soft tissue.

1 minute: there was slight swelling sense the part, and the surface is without hemorrhagic focus.

2 minutes: there was the swelling sense on the surface, as seen hemorrhage the or ecchymosis kitchen range of fritter was arranged, area 0.5cm ²About.

3 minutes: obvious subcutaneous hemorrhage, ecchymosis, edema were seen in the surface, area 2.5cm ²About.

4 minutes: large-area hemorrhage, ecchymosis, edema were seen in the surface, and area is greater than 3.5cm ²

Each treated animal is dissected after putting to death, get and dampen 1 of position muscular tissue, be fixed in 10% formalin solution, take out the flowing water flushing after 72 hours, the gradient ethanol dehydration, dimethylbenzene is transparent, the waxdip embedding, section, HE dyeing, resinene rubber seal sheet, the pathological manifestations such as traumatic aseptic inflammation reaction of observation by light microscope wound local organization.The pathology damage degree is made an appraisal, make Ridit and analyze, take a picture.Each organizes all attached color photomicrographies of muscular tissue.The lesion degree evaluation criterion is as follows:

"-": the normal muscle tissue, have no congested, congestion, muscular tissue has no swelling, and a matter has no inflammation.

"+": muscular tissue swelling is not obvious, and a small amount of inflammatory cell infiltration is arranged.

" ++ ": muscular tissue swelling has inflammatory cell infiltration.

" +++": the swelling of part muscular tissue, a matter inflammation is obvious.

The setting of dosage: (the same).

2.3 result

Medicine of the present invention is high, (2.4g crude drug/kg, 1.2g crude drug/kg) obviously reduce damage index value (comparing P＜0.05, P＜0.01 with model group) to middle dosage.The results are shown in Table 2.

Wound local organization pathologic finding, the perusal result: model group rat muscle tissue has obvious hyperemia, congestion.Positive drug group, the hyperemia of the high, medium and low dosage group of medicine of the present invention rat muscle tissue, congestion all alleviate (comparing P＜0.05 with model group) to some extent.The Ridit analysis result sees Table 3.

Microscopic observation: the swelling of the most of muscular tissue large tracts of land of model group, muscular tissue obviously increases slightly, and the profit dish disappears, lose normal muscular arrangement, between matter have subregion muscle fiber color to shoal, a matter inflammatory cell infiltration is take small lymphocyte as main, responding property of muscular tissue cell hypertrophy.Medicine of the present invention is high, middle dosage group can significantly be improved myocyte's swelling degree (comparing P＜0.05, P＜0.01 with model group).See Fig. 1～Fig. 6

To muscle swelling degree statistics, do the t check analysis, the results are shown in Table 4

Table 2 is on the impact of rat soft tissue injury degree

Annotate: compare with the model contrast, ^*P＜0.05, ^*P＜0.01

Table 3 is on the impact of rat soft tissue injury pathological change

Annotate: Ridit analyzes, fiducial limit lower limit＞0.5 o'clock, P＜0.05.

Table 4 is on the impact of rat muscle swelling degree

Annotate: compare with the model contrast, ^*P＜0.05, ^*P＜0.01

Experimental example 2 antiinflammatory actions

1. Oleum Tiglii is caused the antiinflammatory action of mice ear

1.1 material:

Mice, the Kunming kind, the cleaning level, male, body weight 18～22g is provided by Inst. of Genetics and Development Biology, CAS's animal center, quality certification SCXK (capital) 2002-0006.

Medicine, reagent and instrument: medicine of the present invention (4.28g crude drug/g), provided by Gansu Qizheng Tibetan Medicine Co., Ltd; Blank substrate provides by Gansu Qizheng Tibetan Medicine Co., Ltd; The prednisolone acetate injection, Zhejiang Province XianJu Pharmacy stock Co., Ltd; Dehydrated alcohol, analytical pure, Beijing Chemical Plant; Ether, analytical pure, Red Star chemical plant, Beijing.

Electronic balance, LIBROR EB-280M-22, Japanese Shimadzu instrument company.

1.2 method

60 of mices, stratified random is divided into model control group (to substrate), medicine of the present invention is high, in, low dose group (3.6g crude drug/kg, 1.8g crude drug/kg, 0.9g crude drug/kg) and positive drug prednisolone acetate injection group (25mg/kg), wherein except positive drug is intraperitoneal injection, all the other are percutaneous dosing, successive administration 3 days, every day 1 time is behind the last administration 1h, (Oleum Tiglii: ethanol: ether=0.2: 2: 7.8) 50 μ l/ only to smear 2% Oleum Tiglii at the left side auricle, put to death behind the 4h, wide with the rustless steel blunderbuss blunderbuss bottom left auris dextra of diameter 8mm, weigh, calculate the ear swelling rate, organize a t check.Ear swelling rate computing formula is as follows:

Ear swelling rate=(left ear weight-auris dextra is heavy)/auris dextra heavy * 100%

The setting of dosage:

Clinical plan dosage is: everyone intended external and was affixed on the affected part every day: 2.7g (crude drug)/d/ people, every day per kilogram people consumption: 2.7g ÷ 60kg=0.045g (crude drug)/kg.

Convert with body weight:

The quite clinical plan of mice, high dose is 3.6g (crude drug)/kg with 80 times of dosage; The quite clinical plan of middle dosage is 1.8g (crude drug)/kg with 40 times of dosage; The quite clinical plan of low dosage is 0.9g (crude drug)/kg with 20 times of dosage.

Convert with body surface area:

The quite clinical plan of mice, high dose is with 10.3 times of dosage, and the quite clinical plan of middle dosage is with 5.17 times of dosage, and the quite clinical plan of low dosage is with 2.59 times of dosage.

[high dose: 2.7g (crude drug) ÷ 387.9 (coefficient) ÷ 0.02=0.348g (crude drug)/kg, 3.6g (crude drug)/kg ÷ 0.348=10.3 (doubly)]

1.3 result

Medicine high dose of the present invention (3.6g crude drug/kg), middle dosage (1.8g crude drug/kg) to ear swelling all have significant inhibitory action (with model group relatively, P＜0.05).The results are shown in Table 5.

Table 5 is on the impact of mouse knoting oil ear swelling

Annotate: compare with the model contrast, ^*P＜0.05, ^*P＜0.01.

2. on Carrageenan causes the therapeutical effect of rat paw edema

2.1 material

Medicine and reagent: medicine of the present invention (4.28g crude drug/g), provided by Gansu Qizheng Tibetan Medicine Co., Ltd; Blank substrate provides by Gansu Qizheng Tibetan Medicine Co., Ltd; Diclofenac, Novartis Pharma AG; Carrageenin, Sigma company.

2.2 method

50 of rats, stratified random is divided into model control group (to substrate), the high, medium and low dosage group (2.4g crude drug/kg of medicine of the present invention, 1.2g crude drug/kg, 0.6g crude drug/kg) and positive drug diclofenac group (the suitable 12mg diclofenac sodium of 1.2g cream/kg/kg), be percutaneous dosing, successive administration 3 days, every day 1 time is behind the last administration 1h, at the carrageenin 100 μ l of its right hind foot sole of the foot section subcutaneous injection 1%, respectively at 1h after the injection, 2h, 4h, 6h is with making tape measuring swelling foot sole of the foot section girth by oneself, calculate the foot swelling rate, organize a t check.Computing formula is as follows:

Foot swelling rate=(injection metapedes sole of the foot girth-injection front foot sole of the foot girth)/injection front foot sole of the foot girth * 100%

The setting of dosage: (the same)

2.3 result

The high, medium and low dosage of medicine of the present invention (2.4g crude drug/kg, 1.2g crude drug/kg, 0.6g crude drug/kg) all can significantly reduce the rear 1h of injection, 2h, 4h, the foot swelling rate of 6h (comparing P＜0.05, P＜0.01 with model group).The results are shown in Table 6.

Table 6 on Carrageenan causes the impact of rat paw edema

Annotate: compare with the model contrast, ^*P＜0.05, ^*P＜0.01

Experimental example 3 analgesic activities

1. to the analgesic activity of the hot whipping of mice

1.1 material

Mice, the Kunming kind, cleaning level, male, body weight 18～22g is provided by Inst. of Genetics and Development Biology, CAS's animal center, the quality certification number: SCXK (capital) 2002-0006.

Medicine and reagent: medicine of the present invention (4.28g crude drug/g), provided by Gansu Qizheng Tibetan Medicine Co., Ltd; Blank substrate provides by Gansu Qizheng Tibetan Medicine Co., Ltd; Diclofenac, Novartis Pharma AG.

1.2 method

60 of mices, stratified random is divided into Normal group (to substrate), the high, medium and low dosage group (3.6g crude drug/kg of medicine of the present invention, 1.8g crude drug/kg, 0.9g crude drug/kg), (1.2g cream/kg is equivalent to 12mg diclofenac sodium/kg) to positive drug diclofenac group.Percutaneous dosing.Measure first the threshold of pain (mice is immersed in 50 ℃ of warm water time getting rid of to afterbody from tail point, hereinafter referred to as TFL) of each mice before the administration with stopwatch, 1h behind the single-dose, 2h, 4h, 6h measure respectively TFL, calculate the analgesia rate, organize a t check.

Analgesia rate=(TFL-threshold of pain)/threshold of pain * 100%

The setting of dosage: (the same).

1.3 result

Medicine of the present invention is high, middle dosage (1h～6h after the administration of 3.6g crude drug/kg, 1.8g crude drug/kg), the TFL prolongation (is compared with matched group, P＜0.05, P＜0.01), analgesic effect is remarkable, low dosage (2h～6h after the administration of 0.9g crude drug/kg), TFL prolong (with matched group relatively, P＜0.05, P＜0.01).The results are shown in Table 7.

The analgesic activity of the table 7 pair hot whipping of mice

Annotate: compare with the model contrast, ^*P＜0.05, ^*P＜0.01

2. on the impact of mice acetic acid twisting

2.1 material

Mice, the Kunming kind, the SPF level, male, body weight 18～22g, section provides by Department Of Medicine, Peking University's Laboratory Animal Science, the quality certification number: SCXK (capital) 2002-0001.

Medicine and reagent

Medicine of the present invention (4.28g crude drug/g), provided by Gansu Qizheng Tibetan Medicine Co., Ltd; Blank substrate provides by Gansu Qizheng Tibetan Medicine Co., Ltd; Diclofenac, Novartis Pharma AG.Acetic acid, analytical pure, Beijing Chemical Plant.

2.2 method

60 of mices, stratified random are divided into model control group (give substrate), the high, medium and low dosage group of medicine of the present invention (3.6g crude drug/kg, 1.8g crude drug/kg, 0.9g crude drug/kg), positive drug diclofenac group (12mg/kg), percutaneous dosing.Behind the single-dose 1h, lumbar injection 0.7% acetum 0.1ml/10g, record is to the writhing number of times in the 15min behind the acetic acid.Organize a t check.

The setting of dosage: (the same).

2.3 result

Medicine of the present invention is high, (3.6g crude drug/kg, 1.8g crude drug/kg) all can obviously reduce mouse writhing number of times (comparing P＜0.05 with model group) show analgesic activity to middle dosage.The results are shown in Table 8.

Table 8 is on the impact of mice acetic acid twisting

Annotate: compare with the model contrast, ^*P＜0.05.

Experimental example 4 function of promoting blood circulation to disperse blood clots

1. on the impact of foot swelling rat blood rheological characteristic

1.1 material

Animal: the SD rat, the cleaning level, male, body weight 190～210g, section provides by Department Of Medicine, Peking University's Laboratory Animal Science.The quality certification number: SCXK (capital) 2002-0001,

Medicine, reagent and instrument: medicine of the present invention (4.28g crude drug/g), provided by Gansu Qizheng Tibetan Medicine Co., Ltd; Blank substrate provides by Gansu Qizheng Tibetan Medicine Co., Ltd; Diclofenac, Novartis Pharma AG, carrageenin, Sigma company.

The whole blood viscosity meter, LBY-N6A, the general Lik-Sang in Beijing instrument company produces; Platelet aggregation instrument, DIC-PA3210, Japan produces; High speed capillary tube centrifuge, KH-120A, Japan produces; Centrifuge, LXZ-II, medical analytical instrument factory in Shanghai produces;

1.2 method

Hind leg foot sole of the foot section subcutaneous injection 1% carrageenin molding method: 61 of rats, stratified random is divided into model control group (to substrate), the high, medium and low dosage group (2.4g crude drug/kg of medicine of the present invention, 1.2g crude drug/kg, 0.6g crude drug/kg) and positive drug diclofenac group (the suitable 12mg diclofenac sodium of 1.2g cream/kg/kg), be percutaneous dosing, other establishes 10 of Normal groups.Successive administration 6 days, every day 1 time, behind the 5th administration 1h, at its right hind foot sole of the foot subcutaneous injection 1% carrageenin 100 μ l of section, 1h after the last administration, carry out platelet aggregation and Determination of Hemorheological Indexes:

Behind the rat anesthesia, through abdominal aortic blood, with 3.8% sodium citrate (1: 9) anticoagulant, make platelet rich plasma and platelet poor plasma with centrifuge after, measure platelet aggregation with platelet aggregation instrument in proportion; Other gets blood and puts in the mensuration cup of rotating cylinder viscometer, measures the whole blood viscosity under the different shear rates; Suck in the capillary tube of whole blood viscosity meter the plasma viscosity when measuring 37 ℃ with above-mentioned platelet poor plasma; With high speed centrifugation after the capillary tube draw blood 5 minutes, read the hematocrit value with the packed cell volume counting chamber; With the capillary tube that runs through the hematocrit value after treatment, go out the content of heat sink albumen with the counting dipstick metering.

The setting of dosage: (the same)

1.3 result

Hind leg foot sole of the foot section subcutaneous injection 1% carrageenin molding method: the medicine of the present invention of various dose all can significantly reduce the heat sink protein content (comparing P＜0.05, P＜0.01 with model control group) of rat model; Medicine of the present invention is high, middle dosage significantly reduces plasma viscosity (comparing P＜0.05 with model control group).See Table 9

2. on the impact of soft tissue injury rat blood rheological characteristic

2.1 material:

Animal: the SD rat, the cleaning level, male, body weight 190～210g, section provides by Department Of Medicine, Peking University's Laboratory Animal Science.The quality certification number: SCXK (capital) 2002-0001

Medicine, reagent and instrument: medicine of the present invention (4.28g crude drug/g), provided by Gansu Qizheng Tibetan Medicine Co., Ltd; Blank substrate provides by Gansu Qizheng Tibetan Medicine Co., Ltd; Diclofenac, Novartis Pharma AG.

The whole blood viscosity meter, LBY-N6A, the general Lik-Sang in Beijing instrument company produces; Platelet aggregation instrument, DIC-PA3210, Japan produces; High speed capillary tube centrifuge, KH-120A, Japan produces; Centrifuge, LXZ-II, medical analytical instrument factory in Shanghai produces; Wound device, this institute hemorheology laboratory is developed voluntarily.

2.2 method:

Wound device and cause the soft tissue injury molding method: slough rat one side calf Mus hair with 20% barium sulfide first, [freely fall with weight and to wound the rat leg muscle with wounding device behind the 24h, Height Adjustable, potential energy transfers to 0.18kgm (quality * weight of potential energy=weight is to the height of limbs)] impact once in the mid calf outside, cause the local soft tissue damage, take " the not broken and interior damage of skin " as degree, if merging skin injury or fracture animal are rejected.60 of the rats of selection modeling success, stratified random is divided into model control group (to substrate), the high, medium and low dosage group (2.4g crude drug/kg of medicine of the present invention, 1.2g crude drug/kg, (1.2g cream/kg is equivalent to 12mg diclofenac sodium/kg) for 0.6g crude drug/kg) and positive drug diclofenac group.Except other established 10 rats of Normal group, all the other respectively organized the percutaneous successive administration 5 days, every day 1 time, behind the last administration 1h, carried out platelet aggregation and Determination of Hemorheological Indexes (method is with 1.2)

2.3 result:

Wound device and cause the soft tissue injury molding method: medicine high dose of the present invention ((compare with model group by the whole blood viscosity when 2.4g crude drug/kg) can significantly reduce shear rate and is 10/s, 50/s, P＜0.05), medicine of the present invention is high, middle dosage (2.4g crude drug/kg, 1.2g crude drug/kg) can reduce the content (comparing P＜0.01 with model group) of heat sink albumen.The results are shown in Table 10.

Table 9 on Carrageenan causes the impact of rat platelet aggregation and hemorheology sexual disorders

Annotate: compare with the model contrast, ^*P＜0.05, ^*P＜0.01.

Table 10 is on the impact of soft tissue injury rat platelet aggregation and hemorheology sexual disorders

Annotate: compare with the model contrast, ^*P＜0.05, ^*P＜0.01.

Experimental example 5 preparation researches

1, preparations shaping Journal of Sex Research

This product is 70% ethanol Chinese medicine extract, and in order to improve the affinity of medicine and skin, we have carried out following research to the medicinal liquid mouldability:

According to trial test, polyvidone, hypromellose are configured to suitable concentration with 70% ethanol are configured, and observe its dissolubility, on the impact of jet angle and to feeling to carry out subjective assessment after using.The results are shown in Table 11

Table 11 preparations shaping Journal of Sex Research

Annotate: PVP (polyvidone), HPMC (hydroxypropyl emthylcellulose)

Analyze and the result: as shown in Table 11, the jet angle size diminishes along with the increase of medicinal liquid viscosity, in conjunction with dissolubility and use subjective assessment, K in PVP (polyvidone) series ₃₀Consumption 3% is comparatively suitable.

This product is alcoholic solution, and is dry very fast after the drug use, easily makes xerosis cutis, is unfavorable for the further absorption of medicine.For medicine is fully contacted with skin, improve patient's comfort, we have carried out the moisture retention test, the results are shown in Table 12.

The research of table 12 moisture retention

Based on the above results: we select PVP (polyvidone) 3%, and glycerol 0.5% is the best proportioning of medicinal liquid molding adjuvant.

2, propellant

The injection rate of aerosol is the important technological parameters of product, injection rate is subjected to directly affecting of propellant consumption, in order to determine the optimum amount of prescription propellant, carry out following design: the propellant consumption has been designed 7 gradients, the variation of index is respectively investigated in contrast under same test conditions, the results are shown in Table 13.

Table 13 propellant consumption is on the impact of product

Analyze and conclusion: analyzed by upper table 13, along with the increase of propellant consumption, the dose that is sprayed on skin reduces gradually, and dosage is convenient to control, and the suitability strengthens.Because propellant and medicine have certain meltage, being below or above the dissolving marginal value all can affect product appearance and use.Overall merit, best propellant proportioning is: medicinal liquid: propellant=40: 11 (ml: g).

3, propellant selection:

The character of Chinese medicine extract is subjected to the impact of the many factors such as medical material collecting time, the place of production, in conjunction with following operability of producing, adopts medicinal liquid liquid volume, and propellant is studied the compatibility of medicine and propellant with the method for weight.

(1) dimethyl ether is on the impact of medicine

In conjunction with the physicochemical property of dimethyl ether and HFC-134a, we measure medicinal liquid 20ml, are filled with respectively not commensurability propellant, the intermiscibility of contrast dimethyl ether and HFC-134a and medicine, and result of the test sees Table 14.

Table 14 propellant and the experiment of medicine intermiscibility

Analyzed as can be known by table 14:

1. dimethyl ether can dissolve each other with medicinal liquid, but along with the increase of the amount of dimethyl ether, drug solubility changes, and the medicinal liquid middle part is divided into and analyzes.

2. HFC-134a and medicinal liquid have certain dissolubility, and along with the increase of the amount of dimethyl ether, layering appears in system, and the upper strata is the clarification medicinal liquid that has dissolved part HFC-134a, and lower floor is excessive HFC-134a.

(2) HFC-134a is on the impact of medicine

According to the propellant compatibility test, get an amount of medicinal liquid and add not commensurability HFC-134a, observe the propellant consumption to the impact of medicinal liquid dissolubility, system saturation pressure, the results are shown in Table 15

Table 15HFC-134a and the experiment of medicine intermiscibility

Remarks: this product saturation pressure, separation time all are to measure behind the medicinal liquid shake well.No. 4 test propellant meltages are maximum, so the time used impelling dosage can be used as in critical reference.

Analyze and conclusion: by upper table analysis as can be known, the saturated vapour pressure of propellant is without significant change, and according to its physicochemical property, saturated vapor pressure only is subjected to the impact of ambient temperature, along with the rising of temperature, and the corresponding increase of saturated vapor pressure.Because the distinctive physicochemical property of propellant, packing jar is intrinsic pressure all the time greater than external pressure, and under the condition of medicine and propellant mixing, a small amount of propellant can spray medicine fully, can not occur residual.According to propellant and amount of liquid medicine effect relationship, HFC-134a and medicine intermiscibility are better.

Description of drawings:

Fig. 1: HE dyeing 10 * 40, matched group, the rat muscle tissue, the muscle injury tissue is normal, and a matter has no inflammation

Fig. 2: HE 10 * 40 model group that dye, Damage of Rats muscular tissue, muscle injury is organized obvious tumefaction, a matter inflammatory cell infiltration

Fig. 3: HE 10 * 40 positive drug groups that dye, Damage of Rats muscular tissue, matter has mild inflammation between the muscle injury tissue

Fig. 4: HE 10 * 40 medicine high dose group of the present invention that dye, Damage of Rats muscular tissue, muscle injury tissue and inflammation obviously alleviate

Dosage group in Fig. 5: HE dyeing 10 * 40 medicines of the present invention, Mus muscle injury tissue, muscle injury tissue and inflammation alleviate

Fig. 6: HE 10 * 40 medicine low dose group of the present invention that dye, Damage of Rats muscular tissue, matter has mild inflammation between the muscle injury tissue

Following embodiment all can realize the effect of above-mentioned experimental example.

The specific embodiment

Embodiment 1:

Crude drug forms:

Radix Lamiophlomidis Rotatae 10g, Herba Oxytropis Kansuensis 5g, Rhizoma Curcumae Longae 30g, Pericarpium Zanthoxyli 15g, Cornu Bubali 10g, Cacumen Myricariae Germanicae 30g, Flos Carthami 1g, Borneolum Syntheticum 1g, Camphora 1g;

Adjuvant is:

Polyvidone 6g, glycerol 2g, tween 80 9g, tetrafluoroethane 30g.

Radix Lamiophlomidis Rotatae, Herba Oxytropis Kansuensis, Rhizoma Curcumae Longae, Pericarpium Zanthoxyli, Cornu Bubali, Cacumen Myricariae Germanicae, Flos Carthami are added 60% alcohol reflux 2 times, each 0.5 hour, each 8 times of quantity of solvent, collecting decoction filters, and is condensed into the clear paste of 1.05-1.10 (60 ℃), and is for subsequent use; Borneolum Syntheticum, Camphora, glycerol, Tween 80, polyvidone 60% dissolve with ethanol, for subsequent use.Mentioned solution and clear paste are merged, add ethanol and make and contain the alcohol amount and be 40%-50%, 1000ml processed altogether, mixing leaves standstill, and filters, fill, and sealing is filled with tetrafluoroethane (HFC-134a) and get final product.

Embodiment 2:

Crude drug forms:

Radix Lamiophlomidis Rotatae 12g, Herba Oxytropis Kansuensis 4g, Rhizoma Curcumae Longae 20g, Pericarpium Zanthoxyli 10g, Cornu Bubali 11g, Cacumen Myricariae Germanicae 25g, Flos Carthami 1.5g, Borneolum Syntheticum 1.5g, Camphora 2g.

Adjuvant is:

Polyvidone 7g, glycerol 1.5g, tween 80 20g, tetrafluoroethane 40g.

Radix Lamiophlomidis Rotatae, Herba Oxytropis Kansuensis, Rhizoma Curcumae Longae, Pericarpium Zanthoxyli, Cornu Bubali, Cacumen Myricariae Germanicae, Flos Carthami are added 85% alcohol reflux 1 time, extracted 2.5 hours, each 6 times of quantity of solvent, collecting decoction filters, and is condensed into the clear paste of 1.20-1.25 (60 ℃), and is for subsequent use; Borneolum Syntheticum, Camphora, glycerol, Tween 80, polyvidone 40% dissolve with ethanol, for subsequent use.Mentioned solution and clear paste are merged, add ethanol and make and contain the alcohol amount and be 50%-60%, 1000ml processed altogether, mixing leaves standstill, and filters, fill, and sealing is filled with tetrafluoroethane (HFC-134a) and get final product.

Embodiment 3:

Crude drug forms:

Radix Lamiophlomidis Rotatae 7g, Herba Oxytropis Kansuensis 6g, Rhizoma Curcumae Longae 20g, Pericarpium Zanthoxyli 15g, Cornu Bubali 8g, Cacumen Myricariae Germanicae 25g, Flos Carthami 1.5g, Borneolum Syntheticum 1.5g, Camphora 2g.

Adjuvant is:

Polyvidone 3g, glycerol 3g, tween 80 40g, tetrafluoroethane 40g.

Radix Lamiophlomidis Rotatae, Herba Oxytropis Kansuensis, Rhizoma Curcumae Longae, Pericarpium Zanthoxyli, Cornu Bubali, Cacumen Myricariae Germanicae, Flos Carthami are added 70% alcohol reflux 3 times, each 1 hour, each 14 times of quantity of solvent, collecting decoction filters, and is condensed into the clear paste of 1.00-1.05 (60 ℃), and is for subsequent use; Borneolum Syntheticum, Camphora, glycerol, Tween 80, polyvidone 70% dissolve with ethanol, for subsequent use.Mentioned solution and clear paste are merged, add ethanol and make and contain the alcohol amount and be 70%-80%, 1000ml processed altogether, mixing leaves standstill, and filters, fill, and sealing is filled with tetrafluoroethane (HFC-134a) and get final product.

Embodiment 4:

Crude drug forms:

Adjuvant is:

Polyvidone 6g, glycerol 2g, tween 80 9g, tetrafluoroethane 30g.

Radix Lamiophlomidis Rotatae, Herba Oxytropis Kansuensis, Rhizoma Curcumae Longae, Pericarpium Zanthoxyli, Cornu Bubali, Cacumen Myricariae Germanicae, Flos Carthami are added 70% soak with ethanol 24 hours, with 70% ethanol of 10 times of medical material weight, 3ml/kgmin percolation, collect percolate, be condensed into the clear paste of 1.00-1.05 (60 ℃), for subsequent use; Borneolum Syntheticum, Camphora, glycerol, Tween 80, polyvidone 70% dissolve with ethanol, for subsequent use.Mentioned solution and clear paste are merged, add ethanol and make and contain the alcohol amount and be 60%-70%, fill, sealing is filled with tetrafluoroethane (HFC-134a) and get final product.

Embodiment 5:

Crude drug forms:

Adjuvant is:

Polyvidone 7g, glycerol 1.5g, tween 80 20g, tetrafluoroethane 40g.

Radix Lamiophlomidis Rotatae, Herba Oxytropis Kansuensis, Rhizoma Curcumae Longae, Pericarpium Zanthoxyli, Cornu Bubali, Cacumen Myricariae Germanicae, Flos Carthami are added 50% soak with ethanol 72 hours, with 50% ethanol of 5 times of medical material weight, 5ml/kgmin percolation, collect percolate, be condensed into the clear paste of 1.10-1.15 (60 ℃), for subsequent use; Borneolum Syntheticum, Camphora, glycerol, Tween 80, polyvidone 50% dissolve with ethanol, for subsequent use.Mentioned solution and clear paste are merged, add ethanol and make and contain the alcohol amount and be 75%-85%, fill, sealing is filled with tetrafluoroethane (HFC-134a) and get final product.

Embodiment 6:

Crude drug forms:

Adjuvant is:

Polyvidone 3g, glycerol 3g, tween 80 40g, tetrafluoroethane 40g.

Radix Lamiophlomidis Rotatae, Herba Oxytropis Kansuensis, Rhizoma Curcumae Longae, Pericarpium Zanthoxyli, Cornu Bubali, Cacumen Myricariae Germanicae, Flos Carthami are added 40% soak with ethanol 12 hours, with 40% ethanol of 12 times of medical material weight, 3ml/kgmin percolation, collect percolate, be condensed into the clear paste of 1.20-1.25 (60 ℃), for subsequent use; Borneolum Syntheticum, Camphora, glycerol, Tween 80, polyvidone 40% dissolve with ethanol, for subsequent use.Mentioned solution and clear paste are merged, add ethanol and make and contain the alcohol amount and be 60%-70%, fill, sealing is filled with tetrafluoroethane (HFC-134a) and get final product.

Embodiment 7:

Crude drug forms:

Radix Lamiophlomidis Rotatae 6g, Herba Oxytropis Kansuensis 3g, Rhizoma Curcumae Longae 15g, Pericarpium Zanthoxyli 9g, Cornu Bubali 6g, Cacumen Myricariae Germanicae 15g, Flos Carthami 0.2g, Borneolum Syntheticum 0.4g, Camphora 0.4g.

Adjuvant is:

Polyvidone 5g, glycerol 0.8g, tetrafluoroethane 46g.

Radix Lamiophlomidis Rotatae, Herba Oxytropis Kansuensis, Rhizoma Curcumae Longae, Pericarpium Zanthoxyli, Cornu Bubali, Cacumen Myricariae Germanicae, Flos Carthami are added 70% alcohol reflux 3 times, each 1 hour, each 10 times of quantity of solvent, collecting decoction filters, and is condensed into the clear paste of 1.00-1.05 (60 ℃), and is for subsequent use; Borneolum Syntheticum, Camphora, glycerol, polyvidone 70% dissolve with ethanol, for subsequent use.Mentioned solution and clear paste are merged, add ethanol and make and contain the alcohol amount and be 60%-70%, 1000ml processed altogether, mixing leaves standstill, and filters, fill, and sealing is filled with tetrafluoroethane (HFC-134a) and get final product.

Embodiment 8:

Crude drug forms:

Radix Lamiophlomidis Rotatae 15g, Herba Oxytropis Kansuensis 10g, Rhizoma Curcumae Longae 50g, Pericarpium Zanthoxyli 15g, Cornu Bubali 12g, Cacumen Myricariae Germanicae 35g, Flos Carthami 2g, Borneolum Syntheticum 0.5g, Camphora 0.5g.

Adjuvant is:

Polyvidone 8g, glycerol 4g, tetrafluoroethane 85g.

Radix Lamiophlomidis Rotatae, Herba Oxytropis Kansuensis, Rhizoma Curcumae Longae, Pericarpium Zanthoxyli, Cornu Bubali, Cacumen Myricariae Germanicae, Flos Carthami are added 65% alcohol reflux 3 times, each 1 hour, each 6 times of quantity of solvent, collecting decoction filters, and is condensed into the clear paste of 1.25-1.30 (60 ℃), and is for subsequent use; Borneolum Syntheticum, Camphora, glycerol, polyvidone 70% dissolve with ethanol, for subsequent use.Mentioned solution and clear paste are merged, add ethanol and make and contain the alcohol amount and be 50%-60%, 1000ml processed altogether, mixing leaves standstill, and filters, fill, and sealing is filled with tetrafluoroethane (HFC-134a) and get final product.

Embodiment 9:

Crude drug forms:

The above-mentioned composition crude drug adds conventional adjuvant, according to common process, makes ointment.

Embodiment 10:

Crude drug forms:

Embodiment 11:

Crude drug forms:

The above-mentioned composition crude drug adds conventional adjuvant, according to common process, makes tablet.

Claims

1. pharmaceutical composition aerosol for the treatment of acute and chronic bruise, rheumatism or rheumatoid disease is characterized in that in the said composition:

Crude drug is:

Radix Lamiophlomidis Rotatae 5-15 weight portion Herba Oxytropis Kansuensis 2-10 weight portion Rhizoma Curcumae Longae 15-60 weight portion

Pericarpium Zanthoxyli 7-20 weight parts water Cornu Bovis seu Bubali 5-15 weight portion Cacumen Myricariae Germanicae 15-40 weight portion

Flos Carthami 0.1-2.5 weight portion Borneolum Syntheticum 0.1-5 weight portion Camphora 0.1-5 weight portion;

Adjuvant is:

Polyvidone 1-10 weight portion glycerol 0.5-5 weight portion solubilizing agent 0-30 weight portion

Propellant 20-100 weight portion.

2. pharmaceutical composition aerosol as claimed in claim 1 is characterized in that the crude drug of said composition is:

Radix Lamiophlomidis Rotatae 10 weight portion Herba Oxytropis Kansuensiss 5 weight portion Rhizoma Curcumae Longaes 30 weight portions

Pericarpium Zanthoxyli 15 weight parts water Cornu Boviss seu Bubali 10 weight portion Cacumen Myricariae Germanicaes 30 weight portions

Flos Carthami 1 weight portion Borneolum Syntheticum 1 weight portion Camphora 1 weight portion.

3. pharmaceutical composition aerosol as claimed in claim 1 is characterized in that the crude drug of said composition is:

Radix Lamiophlomidis Rotatae 12 weight portion Herba Oxytropis Kansuensiss 4 weight portion Rhizoma Curcumae Longaes 20 weight portions

Pericarpium Zanthoxyli 10 weight parts water Cornu Boviss seu Bubali 11 weight portion Cacumen Myricariae Germanicaes 25 weight portions

Flos Carthami 1.5 weight portion Borneolum Syntheticums 1.5 weight portion Camphoras 2 weight portions.

4. pharmaceutical composition aerosol as claimed in claim 1 is characterized in that the crude drug of said composition is:

Radix Lamiophlomidis Rotatae 7 weight portion Herba Oxytropis Kansuensiss 6 weight portion Rhizoma Curcumae Longaes 20 weight portions

Pericarpium Zanthoxyli 15 weight parts water Cornu Boviss seu Bubali 8 weight portion Cacumen Myricariae Germanicaes 25 weight portions

5. such as the arbitrary described pharmaceutical composition aerosol of claim 1-4, it is characterized in that in the adjuvant of this aerosol:

6. pharmaceutical composition aerosol as claimed in claim 5 is characterized in that in the adjuvant of this aerosol:

Tween 80 0-30 weight portion tetrafluoroethane 20-100 weight portion.

7. such as the arbitrary described pharmaceutical composition aerosol of claim 1-4, it is characterized in that the adjuvant of this aerosol is:

Polyvidone 6 weight portion glycerol 2 weight portion tween 80s 9 weight portions

Tetrafluoroethane 90 weight portions.

8. such as the arbitrary described pharmaceutical composition aerosol of claim 1-4, it is characterized in that the adjuvant of this aerosol is:

Polyvidone 3 weight portion glycerol 3 weight portion tween 80s 40 weight portions

Tetrafluoroethane 30 weight portions.

9. such as the arbitrary described pharmaceutical composition aerosol of claim 1-4, it is characterized in that the adjuvant of this aerosol is:

Polyvidone 7 weight portion glycerol 1.5 weight portion tween 80s 20 weight portions

Tetrafluoroethane 50 weight portions.

10. such as the arbitrary described pharmaceutical composition aerosol of claim 1-4, it is characterized in that the adjuvant of this aerosol is:

Polyvidone 9 weight portion glycerol 4.5 weight portion tetrafluoroethane 60 weight portions.

11. the preparation method of pharmaceutical composition aerosol as described in arbitrary such as claim 1-4 is characterized in that the method is:

Radix Lamiophlomidis Rotatae, Herba Oxytropis Kansuensis, Rhizoma Curcumae Longae, Pericarpium Zanthoxyli, Cornu Bubali, Cacumen Myricariae Germanicae, Flos Carthami are added 40-90% alcohol reflux 1-4 time, and each 0.1-3 hour, the each 5-15 of quantity of solvent times, collecting decoction filtered, and 60 ℃ of clear paste that are condensed into 1.00-1.35 are for subsequent use; Borneolum Syntheticum, Camphora, glycerol, solubilizing agent, polyvidone 40-90% dissolve with ethanol, for subsequent use; Mentioned solution and clear paste are merged, add ethanol and make and contain the alcohol amount and be 40-85%, mixing leaves standstill, and filters, fill, and sealing is filled with propellant and get final product.

12. the preparation method of pharmaceutical composition aerosol as described in arbitrary such as claim 1-4 is characterized in that the method is:

Radix Lamiophlomidis Rotatae, Herba Oxytropis Kansuensis, Rhizoma Curcumae Longae, Pericarpium Zanthoxyli, Cornu Bubali, Cacumen Myricariae Germanicae, Flos Carthami were added the 40-90% soak with ethanol 5-72 hour, with the 40-90% ethanol of 2-15 times of medical material weight, 1-5ml/kgmin percolation, collect percolate, 60 ℃ of clear paste that are condensed into 1.00-1.35, for subsequent use; Borneolum Syntheticum, Camphora, glycerol, solubilizing agent, polyvidone 40-90% dissolve with ethanol, for subsequent use; Mentioned solution and clear paste are merged, add ethanol and make and contain the alcohol amount and be 40-85%, mixing leaves standstill, and filters, fill, and sealing is filled with propellant and get final product.

13. the preparation method of pharmaceutical composition aerosol as claimed in claim 11 is characterized in that the method is:

Radix Lamiophlomidis Rotatae, Herba Oxytropis Kansuensis, Rhizoma Curcumae Longae, Pericarpium Zanthoxyli, Cornu Bubali, Cacumen Myricariae Germanicae, Flos Carthami are added 40-90% alcohol reflux 1-4 time, each 0.1-3 hour, the each 5-15 of quantity of solvent doubly, collecting decoction filters, and is condensed into 1.00-1.35(60 ℃) clear paste, for subsequent use; Borneolum Syntheticum, Camphora, glycerol, solubilizing agent, polyvidone 40-90% dissolve with ethanol, for subsequent use; Mentioned solution and clear paste are merged, add ethanol and make and contain the alcohol amount and be 40-85%, mixing leaves standstill, and filters, and gets 150-600 parts by volume medicinal liquid, fill, and sealing is filled with 30-120 weight portion propellant and get final product.

14. the preparation method of pharmaceutical composition aerosol as claimed in claim 12 is characterized in that the method is:

Radix Lamiophlomidis Rotatae, Herba Oxytropis Kansuensis, Rhizoma Curcumae Longae, Pericarpium Zanthoxyli, Cornu Bubali, Cacumen Myricariae Germanicae, Flos Carthami were added the 40-90% soak with ethanol 5-72 hour, with adding 2-15 times of medical material weight of 40-90% ethanol, the 1-5ml/kgmin percolation is collected percolate, be condensed into 1.00-1.35(60 ℃) clear paste, for subsequent use; Borneolum Syntheticum, Camphora, glycerol, solubilizing agent, polyvidone 40-90% dissolve with ethanol, for subsequent use; Mentioned solution and clear paste are merged, add ethanol and make and contain the alcohol amount and be 40-85%, mixing leaves standstill, and filters, and gets 150-600 parts by volume medicinal liquid, fill, and sealing is filled with 30-120 weight portion propellant and get final product.

15. the preparation method of pharmaceutical composition aerosol as claimed in claim 6 is characterized in that the method is:

Radix Lamiophlomidis Rotatae, Herba Oxytropis Kansuensis, Rhizoma Curcumae Longae, Pericarpium Zanthoxyli, Cornu Bubali, Cacumen Myricariae Germanicae, Flos Carthami are added 40-90% alcohol reflux 1-4 time, each 0.1-3 hour, the each 5-15 of quantity of solvent doubly, collecting decoction filters, and is condensed into 1.00-1.35(60 ℃) clear paste, for subsequent use; Borneolum Syntheticum, Camphora, glycerol, solubilizing agent, polyvidone 40-90% dissolve with ethanol, for subsequent use; Mentioned solution and clear paste are merged, add ethanol and make and contain the alcohol amount and be 40-85%, mixing leaves standstill, and filters, and gets 300 parts by volume medicinal liquids, fill, and sealing is filled with 82.5 weight portion propellant and get final product.

16. the preparation method of pharmaceutical composition aerosol as claimed in claim 6 is characterized in that the method is:

Radix Lamiophlomidis Rotatae, Herba Oxytropis Kansuensis, Rhizoma Curcumae Longae, Pericarpium Zanthoxyli, Cornu Bubali, Cacumen Myricariae Germanicae, Flos Carthami were added the 40-90% soak with ethanol 5-72 hour, with adding 2-15 times of medical material weight of 40-90% ethanol, the 1-5ml/kgmin percolation is collected percolate, be condensed into 1.00-1.35(60 ℃) clear paste, for subsequent use; Borneolum Syntheticum, Camphora, glycerol, solubilizing agent, polyvidone 40-90% dissolve with ethanol, for subsequent use; Mentioned solution and clear paste are merged, add ethanol and make and contain the alcohol amount and be 40-85%, mixing leaves standstill, and filters, and gets 300 parts by volume medicinal liquids, fill, and sealing is filled with 82.5 weight portion propellant and get final product.

17. such as the application of described any one pharmaceutical composition aerosol of claim 1-10 in preparation treatment acute and chronic bruise or lumbar muscle strain medicine.

18. such as the application of described any one pharmaceutical composition aerosol of claim 1-10 in preparation treatment traumatic injury stasis of blood pain, old injury and pain, rheumatism or rheumatoid pain medicine.

19. such as the application of described any one pharmaceutical composition aerosol of claim 1-10 in preparation treatment hyperosteogeny, stiff neck or scapulohumeral periarthritis medicine.