CN1772136A - Medicine composition for treating soft tissue damage and osteoarthropathy and its prepn process - Google Patents
Medicine composition for treating soft tissue damage and osteoarthropathy and its prepn process Download PDFInfo
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Abstract
The medicine composition is prepared with 14 kinds of Chinese medicinal materials, including notoginseng, giant knotweed, aconite root, arisaema tuber, pubescent angelica root, etc. in certain weight proportion. The medicine composition and its preparation have the functions of promoting blood circulation to disperse blood clots, relaxing the muscles and joints, eliminating swelling, relieving pain, etc. and are used in treating soft tissue damage, osteoarthropathy, etc. The prepared medicine is yellowish semi-solid with scent, fine ointment, easy painting, easy cleaning and no contamination to clothing.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition that is used for the treatment of diseases such as swelling pain and preparation method thereof.
Background technology
Orthopedics department soft tissue injury and osteoarthrosis are principal character with local swelling pain often, are the common pain card of the traditional Chinese medical science, and be often improper by motion, traumatic injury, and work impairment caused by overstrain and wind-cold damp pathogen invasion and attack muscle arteries and veins kindred etc. causes, often takes place in daily life.Along with the fast development of traffic, building, industry and mining, the quickening of people's rhythm of life, the sickness rate of various bruises, fracture, dislocation increases year by year, and the case of soft tissue injury day by day increases.The patient of soft tissue injury increases with the speed in every year 6～9% according to statistics, causes enormous economic loss for patient individual and country.Therefore, the patient has exigence to the medicine of soft tissue injury.
The traditional Chinese medical science is mainly black plaster to the dosage form of the medicine of orthopedics department soft tissue injury and osteoarthrosis, uses heavy metals such as Plumbum preparatium during production, and contaminated environment can't be arranged production in recent years.In recent years the rubber plaster of making is used gasoline as solvent when producing, produces explosively, produce between the need hoolivan, and also contaminated environment, breathability is bad during application, often causes allergy.It is thick that existing other exterior-applied formulations also exist the mastic darkish complexion, is difficult for coating, and pollution clothes, the not shortcoming of easy cleaning.Therefore, develop the new drug formulation that is used for the treatment of orthopedics department soft tissue injury and osteoarthritis effect and have vast market prospect and huge social benefit.
Summary of the invention
The object of the present invention is to provide a kind ofly be coated with conveniently, the color flat taste is clear, be easy to clean and pharmaceutical composition that is used for the treatment of muscle tendon soft tissue injury and osteoarthritis and preparation method that can pollution clothes.
For reaching above-mentioned purpose, pharmaceutical composition of the present invention is made by following bulk drugs:
1～50 part of Radix Notoginseng, 1～50 part of Rhizoma Polygoni Cuspidati, 1～50 part of Radix Aconiti, 1～50 part of Rhizoma Arisaematis, 1～50 part of Radix Angelicae Pubescentis, 1～50 part of Radix Angelicae Sinensis, 1～50 part of Radix Dipsaci, 1～50 part of Rhizoma Zingiberis, 1～50 part in Fructus Capsici, 1～50 part of Oleum Ocimi Gratissimi, 1～50 part of Oleum Terebinthinae, 1～50 part of Mentholum, 1～50 part of Camphora, 1～50 part of Borneolum Syntheticum.
Preferred version of the present invention is that the weight portion of described crude drug is:
25 parts of Radix Notoginseng, 25 parts of Rhizoma Polygoni Cuspidati, 20 parts of Radix Aconitis, 20 parts of Rhizoma Arisaematiss, 16 parts of Radix Angelicae Pubescentiss, 10 parts of Radix Angelicae Sinensis, 10 parts of Radix Dipsacis, 10 parts of Rhizoma Zingiberiss, 10 parts in Fructus Capsici, 10 parts of Oleum Ocimi Gratissimis, 16 parts of Oleum Terebinthinaes, 26 parts of Mentholums, 13 parts of Camphoras, 13 parts of Borneolum Syntheticums.
With Radix Notoginseng, Radix Aconiti two medicines are monarch in the side, Radix Notoginseng sweetness and bitterness and temperature is gone into Liver Channel, the function removing stasis to stop bleeding, the analgesic therapy of invigorating blood circulation can be stopped blooding and can dissipating blood stasis, hemostasis is arranged and does not stay the stasis of blood, blood stasis dispelling and do not hinder just characteristics is used for various blood disorders, there to be the stasis of blood person that stagnates to be advisable, is the key medicine of promoting blood circulation, removing blood stasis and relieving pain especially; Radix Aconiti is arduous and warm, goes into the conscience kidney channel, function expelling wind and removing dampness, dispersing cold for relieving pain, Compendium of Material Medica: " main strong wind insensitive impediment." be the key medicine of controlling arthralgia due to cold-dampnes.Two medicines share, and a pain relieving with promoting blood flow and remove blood stasis and stop bleeding is used for traumatic injury, and the pain caused by ecchymoma due to frustrating is turned round in the part; One pain relieving with functions dispelling wind and clearing away cold, removing dampness is used for that wind and cold is wet invades, and is weighing pain due to the passages through which vital energy circulates that stagnates.Be equipped with Oleum Caryophylli, Radix Angelicae Sinensis, Radix Angelicae Pubescentis three medicines are minister, Oleum Caryophylli wherein, Xin Wen disperses, and fragrance is walked to scurry, and promoting the circulation of QI to relieve pain are the residence first circulation of qi promoting of invigorating blood circulation, the capable meaning of the capable then blood of gas; The Radix Angelicae Sinensis sweet in the mouth is arduous and warm in nature, goes into the conscience spleen channel, can help the power of pseudo-ginseng blood-circulation-invigovating reducing swelling and alleviating pain, again can tonic blood and growing muscle, and blood stasis dispelling is arranged and do not hinder just wonderfully, be again gas medicine in the blood, make the gas promoting the circulation of blood smooth; Radix Angelicae Pubescentis is arduous and temperature is returned liver and urinary bladder channel, wind-cold damp pathogen that can bitter dry joint, kind again hot loosing passed through inside, and wind-cold damp pathogen is separated outside meridian of Foot-TAI YANG, with Radix Aconiti with expelling wind and removing dampness then, the merit benefit of dispersing cold for relieving pain is very; Rhizoma Polygoni Cuspidati bitter cold in the side is returned the liver and gall lung meridian, and the merit of promoting blood circulation to disperse blood clots and relieves pain is arranged; Rhizoma Arisaematis toil and temperature is returned lung liver spleen channel, the externally used detumescence removing obstruction for relieving pain also has the merit of expelling wind to relieve convulsion; The sweet hot tepor of Radix Dipsaci is returned the Liver and kidney warp, the blood vessels that can pass through, and reducing swelling and alleviating pain and dispelling the wind and dampness pathogens arthralgia pain again can invigorating the liver and kidney, bone and muscle strengthening, the continuous folding of curing the wound is used for deficiency of the liver and kindey, lumbago flaccidity of the lower limbs, and injury from falling down, fracture swells and ache etc.; Rhizoma Zingiberis is hot dry strong, returns taste cardiopulmonary warp, warming spleen and stomach for dispelling cold, recuperating depleted YANG is promoted blood circulation, get its can the cold of warp " send out all " to help the eliminating evil power of Radix Aconiti Radix Angelicae Pubescentis; Fructus Capsici also is the product of hot dispersing cold for relieving pain, and the above five tastes are used it for adjuvant drug altogether.Oleum Terebinthinae, fragrance is hot to loose expelling wind and cold, removing obstruction in the collateral to relieve pain; Camphora, Mentholum are the elite of Lignum cinnamomi camphorae and Herba Menthae, and fragrance is walked to scurry, the kind flesh natural fibre line of meat that reaches, and smooth battalion defends, and deep joint not only can dispel the wind and loose heresy but also can dredge smooth space between skin and muscles, and stimulating the menstrual flow reaches network, and plays the effect of reducing swelling and alleviating pain; Borneolum Syntheticum is the crystallization of Borneolum Syntheticum, causing resuscitation with aromatic drugs for oral administration, the externally used detumescence pain relieving is kindly controlled various pain, more than four flavors, Xin Wen disperses and dispelling cold and removing dampness, fragrance is walked to scurry and meridians dredging, reaches space between skin and muscles and the pain relieving of curing the wound thoroughly, also uses it for adjuvant drug.Borneolum Syntheticum in addition, Mentholum is got its fragrance and is reached thoroughly, and mediation battalion defends, and the priming sick institute that go directly is so doublely be the usefulness of messenger drug.Take a broad view of full side, lay equal stress on, invigorate blood circulation and do not forget circulation of qi promoting with activating blood circulation to dissipate blood stasis and dredge the collateral and functions dispelling wind and clearing away cold, removing dampness, eliminating evilly do not forget to set upright, the monarch and his subjects are orderly, and compatibility is rigorous, all medicines share, and play blood circulation promoting and blood stasis dispelling, meridians dredging altogether, the merit of reducing swelling and alleviating pain makes it battalion and defends sensiblely, and QI and blood is in harmonious proportion, vital QI recovered after pathogens eliminated, then congestive edema is from disappearing, and pain is flat, and all diseases are all removed.
Aforementioned pharmaceutical compositions can add adjuvant such as short skin absorbent, substrate and antiseptic or excipient and make clinical acceptable forms such as externally used paste, propellant, liniment, membrane, gel etc., and above-mentioned pharmaceutical composition can also add suitable adjuvant and make powder.
Preparation of drug combination method of the present invention may further comprise the steps:
A), get above 14 Radix Angelicae Pubescentis, Radix Angelicae Sinensis, the Rhizoma Zingiberiss of flavor in the crude drug, be ground into 20～60 purpose coarse powder, measure 80% ethanol with 6～8 times and make solvent, flood after 24 hours,, collect 1～3 times of amount of liquid of just filtering with the speed percolation of per minute 2～5ml, device is preserved in addition, continue percolation, collect the continuous liquid of filtering, the continuous liquid of filtering is being concentrated into the thick paste shape below 60 ℃, add the liquid of just filtering, with 80% ethanol dilution to 3 times amount, get ethanol extract, put in the clean container standby;
B), get Rhizoma Polygoni Cuspidati, Radix Notoginseng, Rhizoma Arisaematis, Radix Aconiti, Radix Dipsaci, Fructus Capsici, with 6 times of amount 50～80% alcohol reflux 3 times, each 0.5～1.5 hour, filter, merge extractive liquid, reclaims ethanol, is concentrated into the thick paste of 50 ℃ of relative densities 1.10～1.25;
C), get thick paste and mix adjustment volume to 3 times amount, mixing with the ethanol extract of Radix Angelicae Pubescentis, Radix Angelicae Sinensis, Rhizoma Zingiberis;
D), with the aqueous solution of above-mentioned mixed liquid and 10～80 parts of glycerol, 1～10 part of sodium benzoate, 10～50 parts of carbomers, be heated to 60 ℃, become water, with 20% triethanolamine aqueous solution water transfer phase pH to 6.5-7.0;
E), 5～50 parts of azones and emulsifying agent polyoxyethylene sorbitan monoleate are mixed, be heated to 60 ℃, become the adjuvant oil phase, add Oleum Terebinthinae, Mentholum, Borneolum Syntheticum, Camphora, Oleum Ocimi Gratissimi and be mixed into oil phase;
F), oil phase added aqueous phase be stirred to room temperature, obtain the semi-solid medicine.
Crude drug of the present invention is by above preparation technology.
The preparation process of the various common formulations of pharmaceutical composition of the present invention below is described respectively:
(1), the preparation of externally-applied soft ointment: get the semi-solid medicine of gained, weigh, add an amount of adjuvant, mixing obtains externally-applied ointment.Normally used adjuvant is a purified water.
(2), the preparation of propellant: get the semi-solid medicine of gained, weigh, add an amount of adjuvant, make propellant.Normally used adjuvant is a propellant.
(3), the preparation of liniment: the semi-solid medicine of obtaining, the adding appropriate amount of auxiliary materials is made liniment.Normally used adjuvant is the ethanol of 40～80% concentration.
(4), the preparation of membrane: the semi-solid medicine of obtaining, add an amount of adjuvant, make membrane.Normally used adjuvant is polyvinyl alcohol, crylic acid resin, cellulose and other natural macromolecular material.
(5), the preparation of gel: the semi-solid medicine of obtaining, add an amount of adjuvant, make gel.Normally used adjuvant is a carbomer.
(6), the preparation of powder: a), get above ten four Chinese medicines, wherein Radix Angelicae Pubescentis, Radix Angelicae Sinensis, Rhizoma Zingiberis, Rhizoma Polygoni Cuspidati, Radix Notoginseng, Rhizoma Arisaematis, Radix Aconiti, Radix Dipsaci, Fructus Capsici powder is broken into 100～200 order fine powders;
B), azone is mixed the one-tenth oil phase with Oleum Terebinthinae, Mentholum, Borneolum Syntheticum, Camphora, Ocimum Basilicum wet goods;
C), with oil phase and medical material fine powder mixing, make powder.
Advantage of the present invention is: made medicine is faint yellow semisolid, gas delicate fragrance, and the mastic exquisiteness is easy to coating, is easy to clean, can pollution clothes.
Pharmaceutical composition of the present invention has following pharmacological action: Dichlorodiphenyl Acetate lumbar injection and thermostimulation induced mice pain all have significant analgesia role.Dichlorodiphenyl Acetate induced mice abdominal cavity capillary permeability increases and acute inflammation model such as the swelling of rat carrageenan toes, dimethylbenzene induced mice auricle edema all has obvious inhibitory action; The bullate subacute inflammation model of rat granuloma also there is certain inhibitory action.Can promote the subcutaneous ecchymosis of mice to absorb, significantly reduce the ecchymosis area and shorten the ecchymosis extinction time, and can shorten the traumatic ecchymosis of rat and disappear the time of taking off.Can reduce blood stasis model rat whole blood viscosity and plasma viscosity; And can obviously expand rabbit auricle vein blood vessel bore, have the microcirculation improvement effect; The above pharmacological action of this pharmaceutical composition is used for the swelling pain that soft tissue injury and osteoarthritis cause for it is clinical provide experimental basis.
Test furthermore bright effect of the present invention below in conjunction with some:
Experiment one, analgesic test
1.1 test material
1.1.1 be subjected to the reagent thing: the externally-applied soft ointment of pharmaceutical composition of the present invention: 0.224g crude drug/g ointment wherein; Lot number: BN20040809; Provide by Traditional Chinese Medicine University Of Guangzhou new drug center.Bone-setting liquor: Yulin Pharmaceutical Co., Ltd., Guangxi produces, lot number 421117.Barium sulfide: Shanghai Chemical Reagent Co., Ltd., Sinopharm Group, lot number: F20040529; The blank medicine: blank substrate is provided by Traditional Chinese Medicine University Of Guangzhou new drug center.
1.1.2 test dose: the externally-applied soft ointment of pharmaceutical composition of the present invention (the 0.224g crude drug/g), be grown up clinical every day 4 times, a 2g, promptly every day, maximum consumption was 1.79g crude drug/d, to become body weight for humans 60kg, average dosage is 0.0299g crude drug/kg/d.Basic, normal, high three the dosage groups of this test mice are made as 0.3,0.6 respectively, 1.2g crude drug/kg, and above-mentioned dosage is 10,20,40 times (according to the weight) of clinical medicine dose.
1.1.3 animal: the NIH mice, (quality certification number 20030001) provided by Traditional Chinese Medicine University Of Guangzhou's Experimental Animal Center.The SPF level is normally raised after 3 days for examination.
1.2 method and result
1.2.1 influence (hot plate method) to thermostimulation induced mice pain
60 of NIH mices, female, body weight 18～22g, choose 60 of the mice of the basic threshold of pain between 5～30s (from mice is placed hot plate temperature be 55 ± 0.5 ℃ go up to mice begin to lick the time of metapedes as the basic threshold of pain) be divided into 5 groups at random, it is blank substrate matched group, the bone-setting liquor positive controls, ointment height of the present invention, in, low dose group, coating 1 time every day (administration is lost hair or feathers with 8% barium sulfide the previous day), the blank group is coated with the substrate of equivalent, for three days on end, after the last administration, measure behind the medicine 0.5,1.0,2.0h the mice threshold of pain, calculate the threshold of pain and improve percentage rate, relatively each group difference.The results are shown in Table 1.
Table 1 is the result show: the externally-applied ointment high dose of pharmaceutical composition of the present invention can significantly improve 0.5～2h mice threshold of pain and improve percentage rate (P＜0.05～0.01), percentage rate (P＜0.05～0.01) was improved in 1～2h mice threshold of pain after middle dosage can significantly improve medicine, and percentage rate (P＜0.05) was improved in the 1h mice threshold of pain after low dosage then can improve medicine; Percentage rate (P＜0.05～0.01) was improved in 0.5～2h mice threshold of pain after bone-setting liquor can significantly improve medicine.Point out the externally-applied soft ointment of pharmaceutical composition of the present invention to have analgesic activity.
Table 1 pharmaceutical composition ointment of the present invention is to the influence of thermostimulation induced mice pain (x ± s)
| Group | Number of animals only | Dosage g crude drug/kg | Percentage rate (%) is improved in the threshold of pain | ||
| 0.5h | 1h | 2h | |||
| Blank bone-setting liquor ointment of the present invention ointment of the present invention ointment of the present invention | 12 12 12 12 12 | - 10ml 0.3 0.6 1.2 | 6.95±5.23 12.85±7.98 * 11.13±5.58 14.75±12.65 18.15±11.42 ** | 7.21±4.01 22.28±15.70 ** 12.45±6.29 * 18.21±9.83 ** 22.13±13.05 ** | 15.30±11.42 38.31±27.19 * 26.94±14.63 28.66±15.15 * 31.91±19.18 * |
Annotate: compare with blank matrix group,
*P＜0.05,
*P＜0.01
1.2.2 the influence (writhing method) of Dichlorodiphenyl Acetate induced mice pain
Choose 60 of healthy male mices, body weight is 18～22g, be divided into 5 groups at random, be blank substrate matched group, bone-setting liquor positive controls, the high, medium and low dosage group of ointment of the present invention, coating 1 time every day (administration is lost hair or feathers with 8% barium sulfide the previous day), the blank group is coated with the substrate of equivalent, for three days on end, behind the last coating (during experiment, mice elder generation fasting 12 hours) 1 hour lumbar injection 0.8% acetic acid normal saline solution 0.2ml/ only, observed and recorded when injection acetic acid in the time and 20 minutes that body occurs turning round mice turn round the body number of times, respectively organize difference.The results are shown in Table 2.
The influence of table 2 ointment Dichlorodiphenyl Acetate of the present invention induced mice pain (x ± s)
| Group | Number of animals only | Dosage g crude drug/kg | Time of occurrence (second) | Turned round the body number of times in 20 minutes |
| Blank bone-setting liquor ointment of the present invention ointment of the present invention ointment of the present invention | 12 12 12 12 12 | - 10ml 0.3 0.6 1.2 | 243.83±48.46 286.17±32.01 * 277.33±30.15 284.33±28.59 * 320.42±83.58 * | 41.25±7.3 31.25±12.10 * 34.83±7.73 * 33.33±7.80 * 32.33±11.70 * |
Annotate: compare with blank matrix group,
*P＜0.05
From table 2 result as seen, the basic, normal, high dosage of ointment of the present invention all can significantly reduce the acetic acid induced mice and turns round body number of times (P＜0.05) and middle and high dosage and can prolong the time (P＜0.05) that body occurs of turning round; Bone-setting liquor also can significantly reduce turn round body number of times and the prolongation of mice and turn round the time (P＜0.05) that body occurs.Point out ointment of the present invention to have analgesic activity.
Experiment two, antiinflammatory test
2.1 test material
2.1.1 be subjected to the reagent thing: ointment of the present invention: 0.224g crude drug/g ointment; Lot number: BN20040809; Provide positive control drug by Traditional Chinese Medicine University Of Guangzhou new drug center: fluocinonide ointment: specification: 2.5mg/10g, produced lot number 04086005 by Tianjin Pharmaceutical Group Corp., Ltd.The blank medicine: blank substrate is provided by Traditional Chinese Medicine University Of Guangzhou new drug center; Dimethylbenzene: chemical pure, Guangzhou Chemical Reagent Factory, lot number: 0203428; Carrageenin: be Sigma company product, azovan blue: Sigma company product; Acetic acid: reagent one factory in Shanghai produces, lot number: 0103521.
2.1.2 test dose: ointment of the present invention (0.224g crude drug/g), the clinical every day 4 times of being grown up, a 2g, promptly every day, maximum consumption was 1.79g crude drug/d, to become body weight for humans 60kg, average dosage is 0.0299 crude drug/kg/d.Basic, normal, high three the dosage groups of this test mice are made as 0.3,0.6 respectively, 1.2g crude drug/kg, and above-mentioned dosage is 10,20,40 times (according to the weight) of clinical medicine dose; Basic, normal, high three the dosage groups of rat are made as 0.15,0.3 respectively, 0.6g crude drug/kg, and above-mentioned dosage is 5,10,20 times (according to the weight) of clinical medicine dose.
2.1.3 animal: NIH mice (quality certification number 20030001); SD rat (quality certification number 20030001) provides by Traditional Chinese Medicine University Of Guangzhou's Experimental Animal Center.The SPF level is normally raised after 3 days for examination.
2.1.3 instrument: BS110S electronic balance: Sartorius company product; 722 grating spectrophotometers: Shanghai Precision Scientific Apparatus Co., Ltd.Capillary tube amplifying method measuring device.
2.2 method and result
2.2.1 the influence that the mouse peritoneal capillary permeability is increased
Get 60 of NIH mices, body weight 18～22g, male, be divided into 5 groups at random, promptly blank substrate matched group, the fluocinonide positive controls, ointment height of the present invention, in, low dose group, coating 1 time every day (administration is lost hair or feathers with 8% barium sulfide the previous day), the blank group is coated with the substrate of equivalent, for three days on end, 1h after the last administration, each caudal vein inject 2% azovan blue normal saline solution 0.1ml/10g body weight, lumbar injection 0.8% acetic acid normal saline solution 0.2ml/ only immediately, mice is put to death in dislocation behind the 20min, cuts the abdominal cavity open, with the 5ml normal saline flushing for several times, collect washing liquid, centrifugal, get supernatant and survey OD value, relatively each group difference at spectrophotometer 590nm place.The results are shown in Table 3.
The influence that table 3 ointment Dichlorodiphenyl Acetate of the present invention induced mice abdominal cavity capillary permeability increases (x ± s)
| Group | Number of animals only | Dosage g crude drug/kg | The OD value |
| Blank substrate fluocinonide ointment of the present invention ointment of the present invention ointment of the present invention | 12 12 12 12 12 | - 1.25mg 0.3 0.6 1.2 | 0.391±0.145 0.242±0.077. ** 0.289±0.058 * 0.260±0.063 ** 0.253±0.064 ** |
Annotate: compare with blank matrix group,
*P＜0.05,
*P＜0.01
Table 3 is the result show: the high, medium and low dosage group of ointment of the present invention can significantly suppress acetic acid induced mice capillary permeability and increase (P＜0.01～0.05), and is dose-effect relationship; Fluocinonide also can significantly suppress acetic acid induced mice capillary permeability and increase (P＜0.01).Point out ointment of the present invention that the inflammation-inhibiting transudation is arranged.
2.2.2 influence to the swelling of rat carrageenan toes
Choose 50 of SD rats, male, body weight is 150～160g, be divided into 5 groups at random, be blank substrate matched group, fluocinonide positive controls, the high, medium and low dosage group of ointment of the present invention, the left back ankle joint of every Mus is made a clear horizontal line with marking pen before the test, measures rat toes volume with the capillary tube amplifying method.Coating 1 time every day (administration is lost hair or feathers with 8% barium sulfide the previous day) then, the blank group is coated with the substrate of equivalent, for three days on end, the left back sufficient plantar subcutaneous injection 1% carrageenin 0.1ml of every Mus behind the last administration 1h, respectively surveyed Mus toes volume 1 time respectively at 1,2,3,4,5 hour, calculate paw swelling, relatively the difference of each group.The results are shown in Table 4.
Each time point foot volume (ml)-swelling front foot volume (ml) after paw swelling (ml)=swelling
The influence of table 4 ointment on Carrageenan of the present invention rat paw edema (x ± s)
| Group | Number of animals (only) | Dosage (the g crude drug/kg) | Paw swelling (ml) | ||||
| 1h | 2h | 3h | 4h | 5h | |||
| Blank fluocinonide the present invention | 10 10 10 | - 0.625mg 0.15 | 0.40±0.08 0.29±0.10 0.38±0.06 | 0.51±0.10 0.40±0.08 * 0.49±0.07 | 0.54±0.09 0.43±0.07 ** 0.54±0.08 | 0.51±0.09 0.36±0.08 ** 0.50±0.08 | 0.42±0.11 0.31±0.06 ** 0.46±0.07 |
| Ointment ointment of the present invention ointment of the present invention | 10 10 | 0.3 0.6 | 0.38±0.08 0.35±0.07 | 0.42±0.07 * 0.41±0.06 * | 0.45±0.10 * 0.43±0.07 ** | 0.43±0.07 * 0.38±0.08 ** | 0.35±0.08 0.33±0.09 * |
Annotate: compare with blank matrix group,
*P＜0.05,
*P＜0.01
Table 4 is the result show: the dosage group can significantly suppress the paw swelling (P＜0.05) of 1～4h in the ointment of the present invention, and high dose can significantly suppress the paw swelling (P＜0.05～0.01) of 1～5h time point; Fluocinonide also can significantly suppress the paw swelling (P＜0.05～0.01) of 2～5 hours each time points.Point out ointment of the present invention to have resist inflammation on repercussive function.
2.2.3 the influence of xylol induced mice auricle edema
Get 65 of NIH mices, body weight 18～22g, male, be divided into 5 groups at random, it is blank substrate matched group, the fluocinonide positive controls, ointment height of the present invention, in, low dose group, coating 1 time every day (administration is lost hair or feathers with 8% barium sulfide the previous day) then, the blank group is coated with the substrate of equivalent, for three days on end, behind the last administration 1h, 50 μ l drip in the mouse right ear two sides with dimethylbenzene, and left ear is not coated with in contrast, behind the 0.5h mice are taken off cervical vertebra and put to death, with diameter 6mm card punch respectively on a left side, round auricle is laid at the same position of auris dextra, precision is weighed, with a left side, the difference of auris dextra sheet weight compares each group difference as the swelling degree.The results are shown in Table 5.
The influence of table 5 ointment xylol of the present invention induced mice auricle edema (x ± s)
| Group | Number of animals only | Dosage (g crude drug kg) | Ear swelling degree (mg) |
| Blank fluocinonide ointment of the present invention ointment of the present invention ointment of the present invention | 13 13 13 13 13 | - 1.25mg 0.3 0.6 1.2 | 6.12±2.47 4.25±1.61 * 5.15±1.16 4.59±0.97 * 4.62±0.56 * |
Annotate: compare with blank matrix group,
*P＜0.05
Table 5 is the result show: the middle and high dosage of ointment of the present invention can significantly alleviate the auricle swelling degree (P＜0.05) of the scorching mice of caused by dimethylbenzene xylene.Fluocinonide also can significantly alleviate the ear swelling degree (P＜0.05) of mice.Point out ointment of the present invention to have resist inflammation on repercussive function.
2.2.4 ointment of the present invention is to the bullate influence of rat granuloma
Get 50 male SD rats, body weight 140～160g is divided into 5 groups at random, promptly blank substrate matched group, fluocinonide positive controls, the high, medium and low dosage group of ointment of the present invention.Under the ether light anaesthesia, the sterilization of abdominal part unhairing, the cotton balls of will sterilizing (each cotton balls weighs 10 ± 0.5mg, autoclaving, each adds each 1mg/0.1ml of ampicillin, 50 ℃ of oven dry) and implant subcutaneous rat, then sew up.Postoperative began coating 1 time the same day, and the blank group is coated with the substrate of equivalent, and continuous 7 days, dislocation in the 8th day was put to death, and takes out cotton balls, weighed behind 60 ℃ of oven dry 12h, was granuloma induced by implantation of cotton pellets weight, and calculated suppression ratio, the results are shown in Table 6.
Table 6 ointment of the present invention is to the bullate influence of rat granuloma (x ± s)
| Group | Number of animals (only) | Dosage (g crude drug kg) | Granuloma weight (mg) | Suppression ratio (%) |
| Blank fluocinonide ointment of the present invention ointment of the present invention ointment of the present invention | 10 10 10 10 10 | - 0.625mg 0.15 0.3 0.6 | 25.04±3.80 20.24±5.12 * 22.42±1.69 21.71±2.36 * 21.12±2.77 * | 19.17 10.46 13.30 15.65 |
Annotate: compare with blank matrix group,
*P＜0.05
Table 6 is the result show: ointment height of the present invention, middle dosage can significantly alleviate granulation tissue weight (P＜0.05), point out the formation of ointment energy inflammation-inhibiting propagation phase granulation tissue of the present invention.
Experiment three, removing blood stasis to reduce swelling experiment
3.1 test material
3.1.1 be subjected to the reagent thing: ointment of the present invention: 0.224g crude drug/g ointment; Lot number: BN20040809; Provide by Traditional Chinese Medicine University Of Guangzhou new drug center; Positive control drug: bone-setting liquor: Yulin Pharmaceutical Co., Ltd., Guangxi produces, lot number 421117; The blank medicine: blank substrate is provided by Traditional Chinese Medicine University Of Guangzhou new drug center; Heparin: Wanbang Biochemically Pharmaceutical Co Ltd, Xuzhou produces, lot number: 0206108; Barium sulfide: Shanghai Chemical Reagent Co., Ltd., Sinopharm Group, lot number: F20040529.
3.1.2 test dose: ointment of the present invention (0.224g crude drug/g), the clinical every day 4 times of being grown up, a 2g, promptly every day, maximum consumption was 1.79g crude drug/d, to become body weight for humans 60kg, average dosage is 0.0299 crude drug/kg/d.Basic, normal, high three the dosage groups of this test mice are made as 0.3,0.6 respectively, 1.2g crude drug/kg, and above-mentioned dosage is 10,20,40 times (according to the weight) of clinical medicine dose; Basic, normal, high three the dosage groups of rat are made as 0.15,0.3 respectively, 0.6g crude drug/kg, and above-mentioned dosage is 5,10,20 times (according to the weight) of clinical medicine dose.
3.1.3 animal: NIH mice (quality certification number 20030001); SD rat (quality certification number 20030001) provides by Traditional Chinese Medicine University Of Guangzhou's Experimental Animal Center.The SPF level is normally raised after 3 days for examination.
3.2 method and result
3.2.1 ointment of the present invention is to the influence of the traumatic ecchymosis of rat
Get 50 of SD rats, body weight 180～200g, the male and female dual-purpose is divided into 5 groups at random, promptly blank substrate matched group, bone-setting liquor positive controls, the high, medium and low dosage group of ointment of the present invention.Experiment is lost hair or feathers rat back the previous day with 8% barium sulfide, use vice bark pocket skin then, causes subcutaneous hemorrhage (area 4cm * 4cm), ecchymosis occurs after one hour, be applied to the ecchymosis place equably, twice of every day with being about to medicinal liquid, observe the ecchymosis situation that disappears every day, the results are shown in Table 7.
Table 7 ointment of the present invention is to the influence of the traumatic ecchymosis of rat (x ± s)
| Group | Number of animals (only) | Dosage (the g crude drug/kg) | The ecchymosis natural law that disappears |
| Blank bone-setting liquor ointment of the present invention ointment of the present invention ointment of the present invention | 10 10 10 10 10 | - 5ml 0.15 0.3 0.6 | 8.2±0.79 6.9±1.10 ** 7.3±0.95 * 7.2±1.03 * 7.0±1.05 ** |
Annotate: compare with blank matrix group,
*P＜0.05,
*P＜0.01
Table 7 is the result show: ointment of the present invention can significantly shorten ecchymosis dissipation natural law, and is tangible dose-effect relationship.Point out ointment of the present invention to have the removing blood stasis to reduce swelling effect.
3.2.2 ointment of the present invention is tested the mice blood stasis model
Prepare subcutaneous ecchymosis model: with each Mus back depilation 2cm * 3cm, after 1 day, eye socket is got blood 0.4ml with depilatory (8% barium sulfide), and with 50u/ml heparin-saline 0.1ml anticoagulant, subcutaneous injection forms subcutaneous ecchymosis in back depilation place.To make 60 NIH mices of subcutaneous ecchymosis model, male and female half and half are divided equally 5 groups at random, promptly blank matrix group, three dosage groups of the basic, normal, high dosage group of ointment of the present invention, the positive group of bone-setting liquor.After 4 hours, measure the ecchymosis area, as ecchymosis area before the administration.Administration immediately, every day is at ecchymosis top coating, and one day twice, continuous 7 days.And every day measure the ecchymosis area 1 time, disappear until ecchymosis, 7 days disappearance persons not yet were by 7 days.Began promptly to have the ecchymosis of part mice to disappear on the 4th day.So only relatively an ecchymosis extinction time and the 1st, the 2nd, the 3rd, the 4th day ecchymosis area the results are shown in Table 8.
The influence (X ± S n=13) that table 8 ointment of the present invention absorbs the subcutaneous ecchymosis of mice
| Group | Dosage g crude drug/g | Ecchymosis area (mm 2) | Ecchymosis extinction time (d) | ||||
| Before the administration | 1d | 2d | 3d | 4d | |||
| Blank matrix bonesetting liquid ointment of the present invention ointment of the present invention ointment of the present invention | - 10ml 0.3 0.6 1.2 | 47.32± 8.58 48.81± 7.47 50.49± 12.05 53.18± 7.80 46.38± 10.79 | 50.45± 7.84 49.29± 6.99 44.40± 11.70 * 49.76± 8.53 43.85± 9.33 | 48.98± 6.28 43.60± 5.68 * 41.82± 11.01 43.07± 7.87 * 40.37± 9.21 * | 40.56± 9.12 32.18± 8.35 * 32.36± 10.05 * 32.37± 9.78 * 31.75± 7.25 * | 28.66± 12.03 19.00± 6.25 * 19.71± 7.67 * 19.33± 7.21 * 18.70± 4.70 * | 6.2±0.8 5.5±0.8 * 5.7±0.6 5.5±0.8 * 5.4±0.5 ** |
Compare with blank matrix group:
*P＜0.05;
*P＜0.01; The t check
Table 8 as seen, ointment of the present invention can significantly reduce the ecchymosis area and shorten the ecchymosis extinction time.And be dose dependent.Point out ointment of the present invention to have the removing blood stasis to reduce swelling effect.
The experiment four, to hemorheological influence
4.l test material
4.1.1 medicine and reagent
Ointment of the present invention: 0.224g crude drug/g ointment; Lot number: BN20040809; Provide by Traditional Chinese Medicine University Of Guangzhou new drug center.Positive control drug: bone-setting liquor: Yulin Pharmaceutical Co., Ltd., Guangxi produces, lot number 421117.The adrenalin hydrochloride injection, Yongkang, Beijing pharmaceutical factory produces, lot number: 20010406.Heparin: Nanjing Xinbai Pharmaceutical Co produces, lot number: 030101.
4.1.2 test dose: ointment of the present invention (0.224g crude drug/g), the clinical every day 4 times of being grown up, a 2g, promptly every day, maximum consumption was 1.79g crude drug/d, to become body weight for humans 60kg, average dosage is 0.0299 crude drug/kg/d.Basic, normal, high three the dosage groups of this rat are made as 0.15,0.3 respectively, 0.6g crude drug/kg, and above-mentioned dosage is 5,10,20 times (according to the weight) of clinical medicine dose.
4.1.3 animal: the SD rat (quality certification number: 20030001), provide by Traditional Chinese Medicine University Of Guangzhou's Experimental Animal Center.The SPF level is normally raised after three days for examination.
The rotary blood viscosity meter of 4.1.4 instrument: LBY-N6B (Puli gives birth to)
4.2 method and result
Get 60 of SD rats, be divided into 6 groups at random, be i.e. normal control group, blood stasis model group matched group, bone-setting liquor positive drug group, the basic, normal, high dosage group of ointment of the present invention.Every day coating once, matched group gives equivalent blank substrate, except that the normal control group, each is organized every day and irritates stomach (5ml/), continuous 7 days with cold boiled water.In the 7th day except that normal control, all the other respectively organize subcutaneous injection epinephrine (0.08ml/100g), totally 2 times, 4h. (front and back each 2 hours at interval) between the biphasic injection epinephrine immerses 5min in the frozen water with rat at interval, dispose the back fasting and can't help water, get blood in the 8th day each treated animal eye socket, anticoagulant heparin is measured whole blood viscosity, plasma viscosity respectively.The results are shown in Table 9.
As seen from Table 9, behind the rat skin lower injection epinephrine, whole blood viscosity and plasma viscosity all increase to some extent, and this shows the formation of " blood stasis (high blood viscosity) " model.Ointment various dose group of the present invention all can reduce whole blood viscosity and plasma viscosity.Point out ointment of the present invention to have function of promoting blood circulation to disperse blood clots.
Table 9 ointment of the present invention is to the influence of hemorheology of rat (X ± S)
| Group | Dosage (the g crude drug/kg) | Number of animals (only) | Whole blood viscosity | Plasma viscosity |
| Normal control group model bonesetting liquid ointment of the present invention ointment of the present invention ointment of the present invention | - - 10ml 0.15 0.3 0.6 | 10 10 10 10 10 10 | 17.83±1.52 24.94±3.94 20.31±2.63 ** 20.35±5.16 19.84±4.91 * 19.02±1.98 ** | 1.06±0.05 1.39±0.11 1.15±0.07 ** 1.28±0.11 * 1.11±0.08 ** 1.14±0.07 ** |
Annotate: compare with the normal control group:
P＜0.05,
P＜0.01; Compare with model group: * P＜0.05 * * P＜0.01, t check
The experiment five, to microcirculatory influence
5.1 test material
5.1.1 medicine and reagent
Ointment of the present invention: 0.224g crude drug/g ointment; Lot number: BN20040809; Provide by Traditional Chinese Medicine University Of Guangzhou new drug center.Positive control drug: bone-setting liquor: Yulin Pharmaceutical Co., Ltd., Guangxi produces, lot number 421117.
5.1.2 test dose: ointment of the present invention (0.224g crude drug/g), the clinical every day 3 times of being grown up, a 2g, promptly every day, maximum consumption was 1.79g crude drug/d, to become body weight for humans 60kg, average dosage is 0.0299 crude drug/kg/d.Basic, normal, high three the dosage groups of this test new zealand rabbit are made as 0.15,0.3 respectively, 0.6g crude drug/kg, and above-mentioned dosage is 5,10,20 times (according to the weight) of clinical medicine dose.
5.1.3 animal: new zealand rabbit is provided the (quality certification number: 20030001) regular grade by Traditional Chinese Medicine University Of Guangzhou's Experimental Animal Center.
5.2 method and result
Get 50 of body weight 1.2 ~ 1.5kg new zealand rabbits, be divided into 5 groups at random, be i.e. blank group, bone-setting liquor positive drug group, the basic, normal, high dosage group of ointment of the present invention.Each treated animal experiment is preceding with behind the 40% urethane 2ml/kg intraperitoneal injection of anesthesia, with medical rubber patch unhairing on auricle, rabbit ventrad is fixed on down on the rabbit observation platform, the auricle surface drips a little liquid paraffin.Observation platform is placed on the anatomic microscope object stage, under transillumination, smear the variation of same position, ointment of the present invention front and back auricular microcirculation capillary tube bore with 15 * 5 times of sem observation auricles.The results are shown in Table 10.
Table 10 ointment of the present invention is to the influence (X ± S, μ m) of new zealand rabbit auricle venous capillaries bore
| Group | Dosage (the g crude drug/kg) | Number of animals (only) | Before the administration | After the administration | |||
| 5min | Difference | 10min | Difference | ||||
| Blank bonesetting liquid ointment of the present invention ointment of the present invention ointment of the present invention | - 10ml 0.52 1.04 2.08 | 10 10 10 10 10 | 28.3 ±6.8 26.1 ±4.4 29.0 ±9.5 33.1 ±11.5 33.1 ±11.5 | 29.7 ±6.8 30.1 ±6.1 30.9 ±10.2 35.8 ±11.6 36.1 ±11.7 | 1.39 ±0.71 4.19 ±3.29 * 1.85 ±1.12 2.72 ±1.31 * 3.24 ±1.87 ** | 29.3 ±6.9 29.8 ±5.5 30.5 ±9.7 35.4 ±11.6 35.8 ±11.7 | 1.03 ±0.39 3.72 ±2.89 ** 1.46 ±0.66 2.28 ±1.15 ** 2.95 ±1.52 ** |
Annotate: compare: * * P＜0.01, t check with the blank group
As seen from Table 10, give ointment of the present invention after new zealand rabbit auricle vein blood vessel bore increase, with matched group the difference of highly significant is arranged relatively.The result shows the ointment of the present invention new zealand rabbit Auricle Microcirculation effect that has clear improvement.
Experiment six, ointment toxicological study of the present invention
6.1, acute toxicity testing
Application rat, mice carry out acute toxicity testing and show: rat normal skin, injured skin give the ointment 4.48g crude drug/kg of local application of the present invention of maximum concentration, one day 2 times (maximum dosage-feeding is 8.96g crude drug/kg/d, be 600 times of clinical adult's consumption), observed continuously seven days.The result shows that each treated animal general reaction is all no abnormal, body weight gain, ingest, drink water, activity is all normal, none animal dead.Mice oral administration gavage LD of the present invention
50Be 4.93g crude drug/kg (95% credible 4.02～6.04g crude drug/kg) of being limited to, began to occur poisoning symptom behind oral administration gavage the present invention in 5 minutes, poisoning symptom shows as rapid breathing, instability of gait, righting reflex loss, degree of intoxication is relevant with dosage, animal is dead because of respiration inhibition at last, the death time majority is in 20～30 minutes, and minority is in 1～2 hour, and indivedual mices are in 24 hours.It is obviously unusual that postmortem does not find that histoorgan has.Survival mice in viewing duration diet, take the photograph water, movable normal.This product clinical practice is local external use's administration, dosage and can absorb to the amount of whole body less, so can think that the clinical external of this product is safer.
6.2, long term toxicity test
Select the SD rat for use, give variable concentrations (0.6,1.8, the ointment of the present invention of 3.6g crude drug/kg), skin of back was coated with and put on the skin once every day, continuous 30 days, respectively organized 10 animals (male and female half and half) extremely that live in 24 hours after the last administration, all the other 10 animals continuation observation 2 all backs are extremely alive.Duration of test is observed outward appearance, general behavior, the body weight change of animal, after the administration 30 days and carry out hematology's (RBC, HCT, MCV, MCH, MCHC, HB, PLT, CT, WBC and classification, reticulocyte, clotting time) in 2 weeks of drug withdrawal and index inspections such as serum biochemistry (AST, ALT, ALP, Glu, BUN, Crea, TP, T.BIL, ALB, GLOB, A/G, CHOL), urine biochemistry, organ coefficient, histopathology.Result of the test shows: each treated animal general state is good, all no abnormal variation of outward appearance sign, behavioral activity, body weight gain; Three dosage groups and matched group hematological examination, blood biochemical are learned, the urine biochemical analysis is all in normal range, do not have significant difference between group; Each is organized main organs and organizes and do not see that pathology relevant with medicine change.The These parameters drug withdrawal is not seen change after 2 weeks yet.This test dosage is respectively 120,60,20 times of clinical medicine dose, show according to result of the test: basic, normal, high three dosage of ointment of the present invention (0.6,1.8, the 3.6g crude drug/kg) administration in continuous 30 days does not have obvious influence to rat, convalescent period observes and does not also see the retardance toxic reaction, and the dosage safety of prompting this product clinical practice is higher.
6.3, the topical toxicity test
Select new zealand rabbit and Cavia porcellus for use, studied ointment of the present invention normal and damaged skin irritant test, hypersensitive test.The result shows: new zealand rabbit gives ointment of the present invention, does not find tissue abnormalities, proves that ointment of the present invention normally reaches damaged skin to rabbit and do not have obvious irritation.Cavia porcellus allergic experiment result shows that also dermatologic does not cause allergic reaction simultaneously, points out ointment clinical application of the present invention safer.
The specific embodiment
Embodiment 1: the preparation method of the externally-applied soft ointment of pharmaceutical composition of the present invention:
A), get Radix Notoginseng 25g, Rhizoma Polygoni Cuspidati 25g, Radix Aconiti 20g, Rhizoma Arisaematis 20g, Radix Angelicae Pubescentis 16g, Radix Angelicae Sinensis 10g, Radix Dipsaci 10g, Rhizoma Zingiberis 10g, Fructus Capsici 10g, Oleum Ocimi Gratissimi 10g, Oleum Terebinthinae 16g, Mentholum 26g, Camphora 13g, Borneolum Syntheticum 13g be totally ten four flavor crude drug, gets Radix Angelicae Pubescentis wherein, Radix Angelicae Sinensis, Rhizoma Zingiberis, be ground into 20 purpose coarse powder, make solvent, flood after 24 hours with 6～8 times of amount 80% ethanol, with the speed percolation of per minute 2～5ml, collect 1～3 times of amount of liquid of just filtering, device is preserved in addition, continue percolation, collect the continuous liquid of filtering, the continuous liquid of filtering is being concentrated into the thick paste shape below 60 ℃, add the liquid of just filtering, with 80% ethanol dilution to 3 times amount, get ethanol extract, put in the clean container standby;
B), get Rhizoma Polygoni Cuspidati, Radix Notoginseng, Rhizoma Arisaematis, Radix Aconiti, Radix Dipsaci, Fructus Capsici, with 6 times of amount 50～80% alcohol reflux 3 times, each 0.5～1.5 hour, filter, merge extractive liquid, reclaims ethanol, is concentrated into the thick paste of 50 ℃ of relative densities 1.10～1.25;
C), get thick paste and mix adjustment volume to 3 times amount, mixing with the ethanol extract of Radix Angelicae Pubescentis, Radix Angelicae Sinensis, Rhizoma Zingiberis;
D), with the aqueous solution of above-mentioned mixed liquid and 50g glycerol, 5g sodium benzoate 35g carbomer, be heated to 60 ℃, become water, with 20% triethanolamine aqueous solution water transfer phase pH to 6.5-7.0;
E), 30g azone and emulsifying agent polyoxyethylene sorbitan monoleate are mixed, be heated to 60 ℃, become the adjuvant oil phase, add Oleum Terebinthinae, Mentholum, Borneolum Syntheticum, Camphora, Oleum Ocimi Gratissimi and be mixed into oil phase;
F), oil phase added aqueous phase be stirred to room temperature, the semi-solid medicine, weigh, it is an amount of to add purified water, mixing obtains externally-applied ointment.
Embodiment 2: the preparation of pharmaceutical composition propellant of the present invention:
A), get Radix Notoginseng 25g, Rhizoma Polygoni Cuspidati 25g, Radix Aconiti 20g, Rhizoma Arisaematis 20g, Radix Angelicae Pubescentis 16g, Radix Angelicae Sinensis 10g, Radix Dipsaci 10g, Rhizoma Zingiberis 10g, Fructus Capsici 10g, Oleum Ocimi Gratissimi 10g, Oleum Terebinthinae 16g, Mentholum 26g, Camphora 13g, Borneolum Syntheticum 13g be totally ten four flavor crude drug, gets Radix Angelicae Pubescentis wherein, Radix Angelicae Sinensis, Rhizoma Zingiberis, be ground into 40 order coarse powder, make solvent, flood after 24 hours with 6～8 times of amount 80% ethanol, with the speed percolation of per minute 2～5ml, collect 1～3 times of amount of liquid of just filtering, device is preserved in addition, continue percolation, collect the continuous liquid of filtering, the continuous liquid of filtering is being concentrated into the thick paste shape below 60 ℃, add the liquid of just filtering, with 80% ethanol dilution to 3 times amount, get ethanol extract, put in the clean container standby;
B), get Rhizoma Polygoni Cuspidati, Radix Notoginseng, Rhizoma Arisaematis, Radix Aconiti, Radix Dipsaci, Fructus Capsici, with 6 times of amount 50～80% alcohol reflux 3 times, each 0.5～1.5 hour, filter, merge extractive liquid, reclaims ethanol, is concentrated into the thick paste of 50 ℃ of relative densities 1.10～1.25;
C), get thick paste and mix adjustment volume to 3 times amount, mixing with the ethanol extract of Radix Angelicae Pubescentis, Radix Angelicae Sinensis, Rhizoma Zingiberis;
D), with the aqueous solution of above-mentioned mixed liquid and 30g glycerol, 10g sodium benzoate, 40g carbomer, be heated to 60 ℃, become water, with 20% triethanolamine aqueous solution water transfer phase pH to 6.5-7.0;
E), 40g azone and emulsifying agent polyoxyethylene sorbitan monoleate are mixed, be heated to 60 ℃, become the adjuvant oil phase, add Oleum Terebinthinae, Mentholum, Borneolum Syntheticum, Camphora, Oleum Ocimi Gratissimi and be mixed into oil phase;
F), oil phase added aqueous phase be stirred to room temperature, the semi-solid medicine, add propellant, make propellant.
Embodiment 3: the preparation of drug composition liniment of the present invention:
A), get Radix Notoginseng 25g, Rhizoma Polygoni Cuspidati 25g, Radix Aconiti 20g, Rhizoma Arisaematis 20g, Radix Angelicae Pubescentis 16g, Radix Angelicae Sinensis 10g, Radix Dipsaci 10g, Rhizoma Zingiberis 10g, Fructus Capsici 10g, Oleum Ocimi Gratissimi 10g, Oleum Terebinthinae 16g, Mentholum 26g, Camphora 13g, Borneolum Syntheticum 13g be totally ten four flavor crude drug, gets Radix Angelicae Pubescentis wherein, Radix Angelicae Sinensis, Rhizoma Zingiberis, be ground into 60 purpose coarse powder, make solvent, flood after 24 hours with 6～8 times of amount 80% ethanol, with the speed percolation of per minute 2～5ml, collect 1～3 times of amount of liquid of just filtering, device is preserved in addition, continue percolation, collect the continuous liquid of filtering, the continuous liquid of filtering is being concentrated into the thick paste shape below 60 ℃, add the liquid of just filtering, with 80% ethanol dilution to 3 times amount, get ethanol extract, put in the clean container standby;
B), get Rhizoma Polygoni Cuspidati, Radix Notoginseng, Rhizoma Arisaematis, Radix Aconiti, Radix Dipsaci, Fructus Capsici, with 6 times of amount 50～80% alcohol reflux 3 times, each 0.5～1.5 hour, filter, merge extractive liquid, reclaims ethanol, is concentrated into the thick paste of 50 ℃ of relative densities 1.10～1.25;
C), get thick paste and mix adjustment volume to 3 times amount, mixing with the ethanol extract of Radix Angelicae Pubescentis, Radix Angelicae Sinensis, Rhizoma Zingiberis;
D), with the aqueous solution of above-mentioned mixed liquid and 80g glycerol, 10g sodium benzoate, 50g carbomer, be heated to 60 ℃, become water, with 20% triethanolamine aqueous solution water transfer phase pH to 6.5-7.0;
E), 50g azone and emulsifying agent polyoxyethylene sorbitan monoleate are mixed, be heated to 60 ℃, become the adjuvant oil phase, add Oleum Terebinthinae, Mentholum, Borneolum Syntheticum, Camphora, Oleum Ocimi Gratissimi and be mixed into oil phase;
F), oil phase added aqueous phase be stirred to room temperature, the semi-solid medicine, the ethanol that adds 40～80% concentration is an amount of, makes liniment.
Embodiment 4: the preparation of medicinal composition powders of the present invention:
A), get Radix Notoginseng 25g, Rhizoma Polygoni Cuspidati 25g, Radix Aconiti 20g, Rhizoma Arisaematis 20g, Radix Angelicae Pubescentis 16g, Radix Angelicae Sinensis 10g, Radix Dipsaci 10g, Rhizoma Zingiberis 10g, Fructus Capsici 10g, Oleum Ocimi Gratissimi 10g, Oleum Terebinthinae 16g, Mentholum 26g, Camphora 13g, Borneolum Syntheticum 13g, Radix Angelicae Pubescentis wherein, Radix Angelicae Sinensis, Rhizoma Zingiberis, Rhizoma Polygoni Cuspidati, Radix Notoginseng, Rhizoma Arisaematis, Radix Aconiti, Radix Dipsaci, Fructus Capsici powder are broken into 100 purpose fine powders;
B), azone is mixed the one-tenth oil phase with Oleum Terebinthinae, Mentholum, Borneolum Syntheticum, Camphora, Ocimum Basilicum wet goods;
C), with oil phase and medical material fine powder mixing, make powder.
Embodiment 5: the preparation of pharmaceutical composition membrane of the present invention:
A), get Radix Notoginseng 25g, Rhizoma Polygoni Cuspidati 25g, Radix Aconiti 20g, Rhizoma Arisaematis 20g, Radix Angelicae Pubescentis 16g, Radix Angelicae Sinensis 10g, Radix Dipsaci 10g, Rhizoma Zingiberis 10g, Fructus Capsici 10g, Oleum Ocimi Gratissimi 10g, Oleum Terebinthinae 16g, Mentholum 26g, Camphora 13g, Borneolum Syntheticum 13g be totally ten four flavor crude drug, gets Radix Angelicae Pubescentis wherein, Radix Angelicae Sinensis, Rhizoma Zingiberis, be ground into 60 purpose coarse powder, make solvent, flood after 24 hours with 6～8 times of amount 80% ethanol, with the speed percolation of per minute 2～5ml, collect 1～3 times of amount of liquid of just filtering, device is preserved in addition, continue percolation, collect the continuous liquid of filtering, the continuous liquid of filtering is being concentrated into the thick paste shape below 60 ℃, add the liquid of just filtering, with 80% ethanol dilution to 3 times amount, get ethanol extract, put in the clean container standby;
B), get Rhizoma Polygoni Cuspidati, Radix Notoginseng, Rhizoma Arisaematis, Radix Aconiti, Radix Dipsaci, Fructus Capsici, with 6 times of amount 50～80% alcohol reflux 3 times, each 0.5～1.5 hour, filter, merge extractive liquid, reclaims ethanol, is concentrated into the thick paste of 50 ℃ of relative densities 1.10～1.25;
C), get thick paste and mix adjustment volume to 3 times amount, mixing with the ethanol extract of Radix Angelicae Pubescentis, Radix Angelicae Sinensis, Rhizoma Zingiberis;
D), with the aqueous solution of above-mentioned mixed liquid and 80g glycerol, 10g sodium benzoate, 50g carbomer, be heated to 60 ℃, become water, with 20% triethanolamine aqueous solution water transfer phase pH to 6.5-7.0;
E), 50g azone and emulsifying agent polyoxyethylene sorbitan monoleate are mixed, be heated to 60 ℃, become the adjuvant oil phase, add Oleum Terebinthinae, Mentholum, Borneolum Syntheticum, Camphora, Oleum Ocimi Gratissimi and be mixed into oil phase;
F), oil phase added aqueous phase be stirred to room temperature, the semi-solid medicine, add an amount of polyvinyl alcohol or macromolecular materials such as acrylic resin or cellulose, make membrane.
Embodiment 6: the preparation of pharmaceutical composition ointment of the present invention:
A), get Radix Notoginseng 25g, Rhizoma Polygoni Cuspidati 25g, Radix Aconiti 20g, Rhizoma Arisaematis 20g, Radix Angelicae Pubescentis 16g, Radix Angelicae Sinensis 10g, Radix Dipsaci 10g, Rhizoma Zingiberis 10g, Fructus Capsici 10g, Oleum Ocimi Gratissimi 10g, Oleum Terebinthinae 16g, Mentholum 26g, Camphora 13g, Borneolum Syntheticum 13g be totally ten four flavor crude drug, gets Radix Angelicae Pubescentis wherein, Radix Angelicae Sinensis, Rhizoma Zingiberis, be ground into 60 purpose coarse powder, make solvent, flood after 24 hours with 6～8 times of amount 80% ethanol, with the speed percolation of per minute 2～5ml, collect 1～3 times of amount of liquid of just filtering, device is preserved in addition, continue percolation, collect the continuous liquid of filtering, the continuous liquid of filtering is being concentrated into the thick paste shape below 60 ℃, add the liquid of just filtering, with 80% ethanol dilution to 3 times amount, get ethanol extract, put in the clean container standby;
B), get Rhizoma Polygoni Cuspidati, Radix Notoginseng, Rhizoma Arisaematis, Radix Aconiti, Radix Dipsaci, Fructus Capsici, with 6 times of amount 50～80% alcohol reflux 3 times, each 0.5～1.5 hour, filter, merge extractive liquid, reclaims ethanol, is concentrated into the thick paste of 50 ℃ of relative densities 1.10～1.25;
C), get thick paste and mix adjustment volume to 3 times amount, mixing with the ethanol extract of Radix Angelicae Pubescentis, Radix Angelicae Sinensis, Rhizoma Zingiberis;
D), with the aqueous solution of above-mentioned mixed liquid and 60g glycerol, 5g sodium benzoate, 40g carbomer, be heated to 60 ℃, become water, with 20% triethanolamine aqueous solution water transfer phase pH to 6.5-7.0;
E), 40g azone and emulsifying agent polyoxyethylene sorbitan monoleate are mixed, be heated to 60 ℃, become the adjuvant oil phase, add Oleum Terebinthinae, Mentholum, Borneolum Syntheticum, Camphora, Oleum Ocimi Gratissimi and be mixed into oil phase;
F), oil phase added aqueous phase be stirred to room temperature, the semi-solid medicine, weigh, add an amount of purified water, mixing obtains ointment.
Embodiment 7: the preparation of pharmaceutical composition gel of the present invention:
A), get Radix Notoginseng 25g, Rhizoma Polygoni Cuspidati 25g, Radix Aconiti 20g, Rhizoma Arisaematis 20g, Radix Angelicae Pubescentis 16g, Radix Angelicae Sinensis 10g, Radix Dipsaci 10g, in Rhizoma Zingiberis Recens 10g, Fructus Capsici 10g, Oleum Ocimi Gratissimi 10g, Oleum Terebinthinae 16g, Mentholum 26g, Camphora 13g, Borneolum Syntheticum 13g be totally ten four flavor crude drug, gets Radix Angelicae Pubescentis wherein, Radix Angelicae Sinensis, Rhizoma Zingiberis, be ground into 60 purpose coarse powder, make solvent, flood after 24 hours with 6～8 times of amount 80% ethanol, with the speed percolation of per minute 2～5ml, collect 1～3 times of amount of liquid of just filtering, device is preserved in addition, continue percolation, collect the continuous liquid of filtering, the continuous liquid of filtering is being concentrated into the thick paste shape below 60 ℃, add the liquid of just filtering, with 80% ethanol dilution to 3 times amount, get ethanol extract, put in the clean container standby;
B), get Rhizoma Polygoni Cuspidati, Radix Notoginseng, Rhizoma Arisaematis, Radix Aconiti, Radix Dipsaci, Fructus Capsici, with 6 times of amount 50～80% alcohol reflux 3 times, each 0.5～1.5 hour, filter, merge extractive liquid, reclaims ethanol, is concentrated into the thick paste of 50 ℃ of relative densities 1.10～1.25;
C), get thick paste and mix adjustment volume to 3 times amount, mixing with the ethanol extract of Radix Angelicae Pubescentis, Radix Angelicae Sinensis, Rhizoma Zingiberis;
D), with the aqueous solution of above-mentioned mixed liquid and 60g glycerol, 10g sodium benzoate, 50g carbomer, be heated to 60 ℃, become water, with 20% triethanolamine aqueous solution water transfer phase pH to 6.5-7.0;
E), 50g azone and emulsifying agent polyoxyethylene sorbitan monoleate are mixed, be heated to 60 ℃, become the adjuvant oil phase, add Oleum Terebinthinae, Mentholum, Borneolum Syntheticum, Camphora, Oleum Ocimi Gratissimi and be mixed into oil phase;
F), oil phase added aqueous phase be stirred to room temperature, the semi-solid medicine, weigh, add right amount of auxiliary materials such as carbomer, mixing obtains gel.
Embodiment 8: the preparation of medicinal composition powders of the present invention:
A), get Radix Notoginseng 5g, Rhizoma Polygoni Cuspidati 5g, Radix Aconiti 5g, Rhizoma Arisaematis 5g, Radix Angelicae Pubescentis 6g, Radix Angelicae Sinensis 5g, Radix Dipsaci 5g, Rhizoma Zingiberis 5g, Fructus Capsici 5g, Oleum Ocimi Gratissimi 5g, Oleum Terebinthinae 5g, Mentholum 5g, Camphora 5g, Borneolum Syntheticum 5g, Radix Angelicae Pubescentis wherein, Radix Angelicae Sinensis, Rhizoma Zingiberis, Rhizoma Polygoni Cuspidati, Radix Notoginseng, Rhizoma Arisaematis, Radix Aconiti, Radix Dipsaci, Fructus Capsici powder are broken into 200 purpose fine powders;
B), azone is mixed the one-tenth oil phase with Oleum Terebinthinae, Mentholum, Borneolum Syntheticum, Camphora, Ocimum Basilicum wet goods;
C), with oil phase and medical material fine powder mixing, make powder.
Embodiment 9: the preparation of medicinal composition powders of the present invention:
A), get Radix Notoginseng 45g, Rhizoma Polygoni Cuspidati 45g, Radix Aconiti 40g, Rhizoma Arisaematis 40g, Radix Angelicae Pubescentis 46g, Radix Angelicae Sinensis 50g, Radix Dipsaci 50g, Rhizoma Zingiberis 50g, Fructus Capsici 50g, Oleum Ocimi Gratissimi 50g, Oleum Terebinthinae 50g, Mentholum 50g, Camphora 50g, Borneolum Syntheticum 50g, Radix Angelicae Pubescentis wherein, Radix Angelicae Sinensis, Rhizoma Zingiberis, Rhizoma Polygoni Cuspidati, Radix Notoginseng, Rhizoma Arisaematis, Radix Aconiti, Radix Dipsaci, Fructus Capsici powder are broken into 200 purpose fine powders;
B), azone is mixed the one-tenth oil phase with Oleum Terebinthinae, Mentholum, Borneolum Syntheticum, Camphora, Ocimum Basilicum wet goods;
C), with oil phase and medical material fine powder mixing, make powder.
Claims (10)
1. pharmaceutical composition that is used for the treatment of muscle tendon soft tissue injury and osteoarthritis, it is characterized in that: this pharmaceutical composition is made by following bulk drugs: 1～50 part of Radix Notoginseng, 1～50 part of Rhizoma Polygoni Cuspidati, 1～50 part of Radix Aconiti, 1～50 part of Rhizoma Arisaematis, 1～50 part of Radix Angelicae Pubescentis, 1～50 part of Radix Angelicae Sinensis, 1～50 part of Radix Dipsaci, 1～50 part of Rhizoma Zingiberis, 1～50 part in Fructus Capsici, 1～50 part of Oleum Ocimi Gratissimi, 1～50 part of Oleum Terebinthinae, 1～50 part of Mentholum, 1～50 part of Camphora, 1～50 part of Borneolum Syntheticum.
2. the described a kind of pharmaceutical composition that is used for the treatment of muscle tendon soft tissue injury and osteoarthritis of claim 1, it is characterized in that: the weight portion of described crude drug is: 25 parts of Radix Notoginseng, 25 parts of Rhizoma Polygoni Cuspidati, 20 parts of Radix Aconitis, 20 parts of Rhizoma Arisaematiss, 16 parts of Radix Angelicae Pubescentiss, 10 parts of Radix Angelicae Sinensis, 10 parts of Radix Dipsacis, 10 parts of Rhizoma Zingiberiss, 10 parts in Fructus Capsici, 10 parts of Oleum Ocimi Gratissimis, 16 parts of Oleum Terebinthinaes, 26 parts of Mentholums, 13 parts of Camphoras, 13 parts of Borneolum Syntheticums.
3. the pharmaceutical composition that is used for the treatment of muscle tendon soft tissue injury and osteoarthritis as claimed in claim 1 or 2 is characterized in that: this pharmaceutical composition and extract or refining thing can add short skin absorbent, substrate and antiseptic adjuvant or excipient is made clinical acceptable externally used paste, propellant, liniment, membrane or gel and made powder.
4. one kind prepares the method that is used for the treatment of the pharmaceutical composition of muscle tendon soft tissue injury and osteoarthritis as claimed in claim 1, and it is characterized in that: it comprises the steps:
A), get above 14 Radix Angelicae Pubescentis, Radix Angelicae Sinensis, the Rhizoma Zingiberiss of flavor in the crude drug, be ground into 20～60 purpose coarse powder, measure 80% ethanol with 6～8 times and make solvent, flood after 24 hours,, collect 1～3 times of amount of liquid of just filtering with the speed percolation of per minute 2～5ml, device is preserved in addition, continue percolation, collect the continuous liquid of filtering, the continuous liquid of filtering is being concentrated into the thick paste shape below 60 ℃, add the liquid of just filtering, with 80% ethanol dilution to 3 times amount, get ethanol extract, put in the clean container standby;
B), get Rhizoma Polygoni Cuspidati, Radix Notoginseng, Rhizoma Arisaematis, Radix Aconiti, Radix Dipsaci, Fructus Capsici, with 6 times of amount 50～80% alcohol reflux 3 times, each 0.5～1.5 hour, filter, merge extractive liquid, reclaims ethanol, is concentrated into the thick paste of 50 ℃ of relative densities 1.10～1.25;
C), get thick paste and mix adjustment volume to 3 times amount, mixing with the ethanol extract of Radix Angelicae Pubescentis, Radix Angelicae Sinensis, Rhizoma Zingiberis;
D), with the glycerol of above-mentioned mixed liquid and 10～80 parts, 1～10 part sodium benzoate, 10～50 parts the aqueous solution of carbomer, be heated to 60 ℃, become water, with 20% triethanolamine aqueous solution water transfer phase pH to 6.5-7.0;
E), 5～50 parts azones and emulsifying agent polyoxyethylene sorbitan monoleate are mixed, be heated to 60 ℃, become the adjuvant oil phase, add Oleum Terebinthinae, Mentholum, Borneolum Syntheticum, Camphora, Oleum Ocimi Gratissimi and be mixed into oil phase;
F), oil phase added aqueous phase be stirred to room temperature, obtain the semi-solid medicine.
5, as claim 4 described preparation of drug combination methods, it is characterized in that: get the semi-solid medicine of gained, weigh, add appropriate amount of auxiliary materials, mixing obtains externally-applied ointment.
6, as claim 4 described preparation of drug combination methods, it is characterized in that: the semi-solid medicine of obtaining, add appropriate amount of auxiliary materials, make propellant.
7, as claim 4 described preparation of drug combination methods, it is characterized in that: the semi-solid medicine of obtaining, add appropriate amount of auxiliary materials, make liniment
8, as claim 4 described preparation of drug combination methods, it is characterized in that: the semi-solid medicine of obtaining, add appropriate amount of auxiliary materials, make membrane.
9, as claim 4 described preparation of drug combination methods, it is characterized in that: the semi-solid medicine of obtaining, add appropriate amount of auxiliary materials, make gel.
10, a kind of preparation is characterized in that as the claim 1 described preparation of drug combination method that is used for the treatment of muscle tendon soft tissue injury and osteoarthritis:
A), get above ten four Chinese medicines, wherein Radix Angelicae Pubescentis, Radix Angelicae Sinensis, Rhizoma Zingiberis, Rhizoma Polygoni Cuspidati, Radix Notoginseng, Rhizoma Arisaematis, Radix Aconiti, Radix Dipsaci, Fructus Capsici powder is broken into 100～200 purpose fine powders;
B), azone is mixed the one-tenth oil phase with Oleum Terebinthinae, Mentholum, Borneolum Syntheticum, Camphora, Ocimum Basilicum wet goods;
C), with oil phase and medical material fine powder mixing, make powder.
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| CN102641338A (en) * | 2012-05-15 | 2012-08-22 | 山东省血液中心 | Massage medicament for treating soft tissue injury |
| CN103356805A (en) * | 2012-04-06 | 2013-10-23 | 孙武生 | Turpentine and chili oil for treating rheumatism, and bone, muscle and soft tissue injuries and preparation method thereof |
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| CN100335094C (en) * | 2001-12-30 | 2007-09-05 | 湖南三九唯康药业有限公司 | Notoginseng pain relieving plaster and its preparation method |
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| CN103356805A (en) * | 2012-04-06 | 2013-10-23 | 孙武生 | Turpentine and chili oil for treating rheumatism, and bone, muscle and soft tissue injuries and preparation method thereof |
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| CN102641338A (en) * | 2012-05-15 | 2012-08-22 | 山东省血液中心 | Massage medicament for treating soft tissue injury |
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| CN110279746A (en) * | 2019-07-16 | 2019-09-27 | 揭阳市独角金枪草本植物股份有限公司 | A kind of massage cream and preparation method thereof for treating traumatic injury |
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| CN114028483B (en) * | 2021-09-08 | 2022-12-13 | 山东省运动康复研究中心 | Pharmaceutical composition and preparation for treating chronic soft tissue injury |
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