CN100569249C - A kind of Chinese medicine for outer use for the treatment of traumatic pain and preparation method thereof - Google Patents
A kind of Chinese medicine for outer use for the treatment of traumatic pain and preparation method thereof Download PDFInfo
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Abstract
The invention provides a kind of Chinese medicine for outer use for the treatment of traumatic pain and preparation method thereof, it is to be prepared from by Cortex Moutan, Radix Dipsaci, Olibanum, Myrrha, Radix Clematidis, Semen Momordicae, Semen Ricini and Oleum Sesami.It is fine powder that Cortex Moutan is pulverized.Radix Dipsaci and Radix Clematidis flood earlier with Oleum Sesami, and the medicine oil of gained floods ground beetle and Semen Ricini again, and ground beetle and Semen Ricini behind the dipping break into slurry, and the medicine of gained oil adding Cera Flava makes it fusing.Olibanum and Myrrha are ground into fine powder, with Olibanum and Myrrha fine powder, slurry and medicine oil mix homogeneously, add the Cortex Moutan fine powder when temperature is reduced to 80 ℃ and stir then, make various dosage forms according to conventional formulation technology.Compared with prior art, the present invention is raw material with the common Chinese herbal medicine, prescription constitutes fairly simple, product quality is more easy to control, crude drug obtains its effective ingredient through extraction to be made its easier absorption and brings into play drug effect, and the external used medicine of low, the eutherapeutic treatment traumatic pain of a kind of drug cost is provided for the patient.
Description
Technical field
The present invention relates to a kind of preparation for the treatment of traumatic pain and preparation method thereof, particularly relate to a kind of Chinese medicine for outer use for the treatment of traumatic pain and preparation method thereof.
Background technology
Acute or chronic soft tissue injury comprises soft tissue contusion and articular sprain, is orthopaedics commonly encountered diseases, frequently-occurring disease.Gently then sprain and tear the muscular fascia ligament, heavy then injure blood vessel, nerve, as untimely processing, may cause sequela and influence work and study and daily life.After the traumatic injury,, all can cause soft tissue injury no matter have or not fracture.Owing to be considered to the little minor illness of hindering in the past, its treatment is paid little attention to, and how the employing expectant treatment was main in the past, comprised local braking, anti-inflammatory analgetic, neurotrophy and Chinese medicine endo-medicine.But often analgesic effect is very indefinite, or because the long period is taken non-steroidal anti-inflammatory painkiller, causes adverse effectes such as peptic ulcer, dysfunction of platelet, nephrotoxicity.
At present, the medicine of treatment traumatic injury is also more on the market, looses etc. as Radix Notoginseng Tabellae, Flos Carthami, and its therapeutic effect also is sure.But its medical expense is than higher, and treatment cycle is also long.The patient has the demand of treatment as early as possible usually after wound, so that remove slight illness, recover normal work and life.Therefore, develop that the reducing swelling and alleviating pain medicine is just necessary fast and effectively.
Summary of the invention
The invention provides that a kind of drug cost is low, the Chinese medicine for outer use of the treatment traumatic pain of instant effect and preparation method thereof, this Chinese medicine preparation prescription constitutes fairly simple, product quality is more easy to control, crude drug obtains its effective ingredient through extraction to be made its easier absorption and brings into play drug effect, better improve the therapeutic effect of medicine of the present invention, thereby a kind of Chinese medicine for outer use that can more effectively treat traumatic pain is provided.
In order to solve the problems of the technologies described above, the present invention adopts following technical scheme:
According to listed as parts by weight, the Chinese medicine for outer use that the present invention treats traumatic pain is to be prepared from for 20～25 parts by 7～9 parts of Cortex Moutans, 7～9 parts of Radix Dipsacis, 13～15 parts of Olibanums, 13～15 parts of Myrrhas, 12～14 parts of Radix Clematidis, 5～7 parts of Semen Momordicaes, 5～7 parts of Semen Ricini and Oleum Sesami.
Preferably, select following weight portion proportioning for use: 21 parts in 8 parts of Cortex Moutans, 8 parts of Radix Dipsacis, 14 parts of Olibanums, 14 parts of Myrrhas, 13 parts of Radix Clematidis, 6 parts of Semen Momordicaes, 6 parts of Semen Ricini and Oleum Sesami.
The preparation method of the Chinese medicine for outer use of above-mentioned treatment traumatic pain: get Olibanum and Myrrha is ground into fine powder, mix homogeneously, the A product are standby; Get Cortex Moutan and be ground into fine powder, it is standby to get the B product; Get Radix Dipsaci and Radix Clematidis and put into 80～100 ℃ Oleum Sesami, flood 2.5～4 hours after-filtration, filtering residue discards need not, adding Semen Momordicae and Semen Ricini in filtrate filters after 2.5～4 hours once more in 80～100 ℃ of dippings, oily slurry is made in the filtering residue making beating, it is standby to get the C product, filtrate adds Cera Flava and makes it fusing under 80～100 ℃ of conditions, add the A product then and the C product stir, treat to add when temperature is chilled to 80 ℃ the B product, stir, be chilled to after the room temperature routinely preparation process and make various exterior-applied formulations.
External use plaster of the present invention is like this preparation: getting Olibanum and Myrrha, to be ground into granularity be 100 purpose fine powders, mix homogeneously, the A product are standby; Get the Cortex Moutan pulverizing and be granularity 100 purpose fine powders, it is standby to get the B product; Get Radix Dipsaci and Radix Clematidis and put into 90 ℃ Oleum Sesami, flood 3 hours after-filtration, filtering residue discards need not, adding Semen Momordicae and Semen Ricini in filtrate filters after 3 hours once more in 90 ℃ of dippings, oily slurry is made in the filtering residue making beating, it is standby to get the C product, filtrate adds Cera Flava and makes it fusing under 90 ℃ of conditions, add the A product then and the C product stir, add the B product when treating that temperature is chilled to 80 ℃, stir, make the uniform circular cream sheet of thickness with pelleter after being chilled to room temperature, place in the medical air-permeable adhesive tape, make external use plaster.
The present invention's prescription selects for use Cortex Moutan, Radix Dipsaci, Olibanum, Myrrha, Radix Clematidis, Semen Momordicae, Semen Ricini and Oleum Sesami to make up, these drug regimens are made each medicine Synergistic together, play the effect of blood circulation and promoting silt, reducing swelling and alleviating pain, strengthening the tendons and bones altogether, thereby effectively treat congestion resistance network card, acute and chronic soft tissue injury person.It is because of Cortex Moutan bitter in the mouth, suffering that the present invention selects Cortex Moutan for use, cold nature, and GUIXIN, liver, kidney channel, clearing away heat and cooling blood, blood circulation promoting and blood stasis dispelling is used for the temperature poison and sends out class, hematemesis and epistaxis, night fever abating at dawn, lossless hectic fever due to YIN-deficiency, the amenorrhea dysmenorrhea, carbuncle sore tumefacting virus falls and pounces on the pain of injury.Radix Dipsaci bitter in the mouth, suffering, slightly warm in nature is returned liver, kidney channel, invigorating the liver and kidney, bone and muscle strengthening, continuous folding is hindered, and ends metrorrhagia, is used for soreness of the waist and knees, rheumatic arthralgia, metrorrhagia, vaginal bleeding during pregnancy, injury from falling down.Prepared RADIX DIPSACI with yellow rice wine is used for rheumatic arthralgia more, injury from falling down.Olibanum acrid in the mouth, hardship, warm in nature.Promoting blood circulation and stopping pain is used for all pains of trusted subordinate, the contracture of muscle arteries and veins, traumatic injury, sore, carbuncle and painful swelling; The externally used detumescence granulation promoting.The Myrrha bitter in the mouth, suffering, property is flat, goes into liver, spleen, the heart, kidney channel, the blood blood stasis removing that looses, subduing swelling and relieving pain is used to control traumatic injury, incised wound, muscles and bones, all pains of trusted subordinate, lump in the abdomen, amenorrhea, ulcer sore pain, anal fistula, diseases of the eye.Radix Clematidis acrid in the mouth, salty, warm in nature, return urinary bladder channel, expelling wind and removing dampness, removing obstruction in the collateral to relieve pain is used for rheumatic arthralgia, numb limbs and tense tendons, the contracture of muscle arteries and veins, joint stuffiness, the bone larynx of choking with sobs.Semen Momordicae, bitter but slightly sweet taste, warm in nature, poisonous, go into liver, spleen, stomach warp, eliminating stagnation, the poison of dispelling is controlled carbuncle, furuncle, scrofula, hemorrhoid, innominate toxic swelling, tinea skin ulcer, rheumatic arthralgia, the contracture of muscle arteries and veins.Semen Ricini sweet in the mouth suffering, property is flat, and is slightly poisonous, goes into large intestine channel, and detumescence and drawing out poison rushes down logical stagnating down, controls swollen ulcer drug, scrofula, sore throat, mange tinea skin ulcer, edema abdominal distention, constipation due to dry stool.The Oleum Sesami nature and flavor are sweet, cool, have the effect of loosening bowel to relieve constipation, removing toxic substances and promoting granulation, clinically also decoct plaster with Oleum Sesami, granulation promoting meat arranged, the effect of the pain that relieves the pain, subduing inflammation, benefit rhagades of the skin, are used as ointment machin plaster substrate outward.
In order to ensure the effectiveness and the drug safety of medicine of the present invention, the applicant has carried out zooperies such as effectiveness, safety.
One, main pharmacodynamics research
1, material source
1.1 the preparation of ointment
Getting Olibanum 280g and Myrrha 280g, to be ground into granularity be 100 purpose fine powders, mix homogeneously, the A product are standby; Get Radix Cynanchi Paniculati 160g and pulverize to granularity is 100 purpose fine powders, it is standby to get the B product; Get the Oleum Sesami 420g that Radix Clematidis 260g puts into 90 ℃, flood 3 hours after-filtration, filtering residue discards need not, adding Semen Momordicae 150g and Semen Ricini 140g in filtrate filters after 3 hours once more at 90 ℃ of dippings, oily slurry is made in the filtering residue making beating, and it is standby to get the C product, and filtrate is medicine oil.Take by weighing an amount of Cera Flava and make it to be fused in 90 ℃ the medicine oil, add the A product then and the C product stir, treat to add the B product when temperature is chilled to 80 ℃, stir, promptly get the cream piece after being chilled to room temperature, be pressed into circular external cream sheet by tablet machine.
1.2 laboratory animal source
The Wister/SD rat, male and female half and half, body weight 160 ± 10g is available from Chinese Academy of Medical Sciences Animal Experimental Study center, quality certification SCXK11-00-0006.Kunming/ICR kind mice, male and female half and half, body weight 21 ± 1g provides credit number by Beijing dimension tonneau China experimental animal technical research institute: SCXK (capital)-2002-0003.
2, dosage design: 60kg people's one consumption per day is the 2.3g ointment, 0.04g/kg/d then, by people and the conversion of animal dose,equivalent, the rat consumption is divided into heavy dose of group 0.4g/kg/d, middle dosage group 0.2g/kg/d, small dose group 0.1g/kg/d, mice and is divided into heavy dose of group 0.8g/kg/d, middle dosage group 0.4g/kg/d, small dose group 0.2g/kg/d in the test, be equivalent to respectively 2 times of people's consumption, etc. doubly and 1/2 times.Each dosage group all adopt ointment by equal-volume not isoconcentration skin smear administration.Medicine is modulated into same volume with excipient (Oleum Sesami).The amount that the dosage of vehicle group Oleum Sesami is adopted when adopting modulation low dose of.
3, method and result
1.1 traumatic pain cream influences normal microcirculation of mouse auricle
Get 60 of healthy Kunming mouses, the male and female dual-purpose.Be divided into 6 groups at random: blank group, excipient matched group, positive drug group (activating meridians to stop pain cream group 18.2cm
2/ kg/d), the large, medium and small dosage group of traumatic pain cream.Each treated animal is by behind the 2% pentobarbital sodium 4mg/kg intraperitoneal injection of anesthesia, and micro-video system is observed same position, auris dextra front microcirculation situation down.Begin administration then, smear medicine at the auris dextra back side, every day 1 time, for three days on end.Observed the same position of auris dextra microcirculation situation of change immediately again with behind the warm water removal medicine on the 4th day.Under monitor, amplify 150 times and measure small artery, venule bore.Compare difference T check between every index employing group and carry out statistical procedures, the result is as shown in table 1:
Table 1 traumatic pain cream is to microcirculation of mouse auricle influence (little external caliber and changing value)
Compare * P＜0.05**P＜0.01 unit: cm with matched group
Table 1 result shows: three dosage groups of traumatic pain cream have obvious expansion Mice Auricle small artery and venular effect, and the changing value and the matched group in sound, CUN KOU footpath relatively have significance difference (P＜0.05 P＜0.01) before and after its administration.
3.2 influence to mice acetic acid pain model
Get 60 of mices, (area is 2 * 3cm in the skin of back depilation
2), be divided into 6 groups at random by body weight then: blank group, vehicle group, positive drug control group, the large, medium and small dosage group of traumatic pain cream, each administration group depilation place skin is smeared administration, the blank group is smeared water, excipient (Oleum Sesami) group is smeared Oleum Sesami, and positive drug control group is smeared activating meridians to stop pain cream (18.2cm
2/ kg/d), and once a day, continuous 4 days, smeared back 1 hour in the 4th day, the acetic acid 0.2ml/ of each animal lumbar injection 0.5% only observes the typical number of times of turning round body of each mice appearance in 20 minutes, compares t check carrying out statistical procedures, result such as table 2 between employing group as a result.
The influence of table 2 traumatic pain cream Dichlorodiphenyl Acetate induced mice pain model
| Group | Number of animals | Turn round body number (inferior) | Suppression ratio % |
| The blank group | 10 | 36.90±6.79 | |
| Vehicle group | 10 | 35.50±4.50 | 3.79 |
| Positive drug control group | 10 | 17.50±2.67** | 52.57 |
| Heavy dose of group | 10 | 14.40±4.76** | 60.97 |
| Middle dosage group | 10 | 16.10±5.95** | 56.36 |
| Small dose group | 10 | 18.00±4.47** | 51.22 |
Compare * * P＜0.01 with model control group
Table 2 result shows: the body number of times of turning round of the large, medium and small dosage group of traumatic pain cream mice obviously is less than model control group behind the injection acetic acid, with model control group significance difference (P＜0.01) is arranged relatively, illustrate that traumatic pain cream Dichlorodiphenyl Acetate induced mice pain has tangible analgesic effect.
3.3 influence to mice hot plate pain model
Water bath with thermostatic control: earlier the water bath topped up with water is made water surface contact hot plate, regulate thermostat and make temperature be controlled at 55 ± 0.5 ℃, hot plate preheating 10 minutes.
Screen qualified mice: get mice, body weight 20 ± 2g, (area is 2 * 3cm in the skin of back depilation
2).Each one is placed on the hot plate, and mice is from being placed on the hot plate to the pain threshold of sufficient required time for this Mus occurring licking.All pain thresholds were less than 5 seconds or all reject greater than 30 seconds or leaper.Repeated measure 2 times is averaged as pain threshold before the medicine.By average pain threshold qualified mice evenly is divided into 6 groups then: blank group, vehicle group, positive drug control group, the large, medium and small dosage group of traumatic pain cream, each administration group depilation place skin is smeared administration, the blank group is smeared water, excipient (Oleum Sesami) group is smeared Oleum Sesami, and positive controls is smeared Tong Luo Qu pain cream 18.2cm
2/ kg/d.Side examination once more in 1 hour after administration.Compare the t check between employing group as a result and carry out statistical procedures, as shown in table 3.
Table 3 traumatic pain cream is to the influence of mice hot plate pain model
| Group | Blank group | The excipient group | Positive controls | Heavy dose of group | Middle dosage group | Small dose group |
| Number of animals | 10 | 10 | 10 | 10 | 10 | 10 |
| Before the medicine | 18.4± 1.37 | 18.2± 2.70 | 18.2± 2.44 | 183± 1.73 | 18.5± 2.11 | 18.4± 1.68 |
| Behind the medicine | 19.2± 1.22 | 19.0± 2.71 | 26.1± 2.32** | 28.8± 2.60** | 27.9± 2.51** | 26.6± 2.22** |
| Difference | 0.8± 0.48 | 0.8± 0.25 | 7.9± 1.82** | 10.5± 2.75** | 9.4± 1.59** | 8.2± 1.54** |
Compare * * P＜0.01 with model control group
Table 3 result shows: the pain threshold of mice obviously increases after the administration of the large, medium and small dosage group of traumatic pain cream, with the blank group significance difference (P＜0.01) is arranged relatively, illustrates that traumatic pain cream has tangible analgesic effect to burn induced mice pain.
3.4 antiinflammatory action:
3.4.1 to the swollen influence that forms of rat granuloma
Get 60 of rats, (area is 4 * 5cm in the back depilation
2).Cut a little otch in the aseptic condition lower back portion after the ether light anaesthesia, then to the subcutaneous sterilization cotton balls of implanting 20mg in both sides.The postoperative random packet is 6 groups, model control group, vehicle group, positive drug group, the large, medium and small dosage group of traumatic pain cream.Operation began to smear administration at depilation place skin the same day, and model control group smears that water, vehicle group are smeared Oleum Sesami, the positive drug group is smeared activating meridians to stop pain cream 12.6cm
2/ kg/d, once a day, continuous 7 days, weighed earlier in the 8th day, behind the medicine 1 hour with the rat sacrificed by decapitation, peel off and take out the cotton balls granulation tissue.Weigh after 12 hours in 60 ℃ of baking oven inner dryings, be the granuloma dry weight, respectively organize granuloma weight, take out thymus and the spleen of rat simultaneously and measure organ index, compare the t check between employing group as a result and carry out statistical procedures, the result is shown in table 4,5.
Table 4 traumatic pain cream is to the swollen influence that forms of rat granuloma
| Group | Number of animals | Granulation is done swollen (mg) | Suppression ratio % |
| Model group | 10 | 38.05±2.62 | |
| Vehicle group | 10 | 37.70±2.25 | 1.05 |
| The positive drug group | 10 | 29.45±3.13 | 22.60 |
| Heavy dose of group | 10 | 28.90±3.61 | 24.04 |
| Middle dosage group | 10 | 30.50±2.76 | 19.84 |
| Small dose group | 10 | 32.70±2.95 | 14.06 |
Compare * P＜0.05 * * P＜0.01 with model control group
Table 4 result shows: three dosage groups of traumatic pain cream can obviously suppress the bullate formation of rat granuloma, with model control group significant difference (P＜0.05 P＜0.01) are arranged relatively.
Table 5 traumatic pain cream is to the influence of spleen and thymus organ index in the swollen formation test of rat granuloma
Table 5 result shows: three dosage groups of traumatic pain cream do not have obvious influence to rat granuloma swollen experiment spleen and thymus organ index.
3.4.2 influence to the mouse skin capillary permeability
Get 60 of mices, (area is 2 * 3cm in the skin of back depilation
2), be divided into 6 groups at random by body weight then: model control group, vehicle group, positive drug control group, the large, medium and small dosage group of traumatic pain cream, each administration group depilation place skin is smeared administration, and model control group smears that water, vehicle group are smeared excipient, positive drug control group is smeared Tong Luo Qu pain cream 18.2cm
2/ kg/d, once a day, for three days on end, each caudal vein was injected the blue liquid 0.1ml/10g of 0.5% ivens with behind the warm water removal medicine in the 4th day, drip dimethylbenzene 40 μ l immediately on the skin, put to death animal after 15 minutes, get orchid and dye skin and shred, be put in distilled water: among acetone (3: 7) the solution 2ml, centrifugal 15 minutes of 3000rpm gets supernatant and measures optical density value in wavelength 590nm place.Compare the t check between employing group as a result and carry out statistical procedures.
Table 6 traumatic pain cream is to the influence of mouse skin capillary permeability
| Group | Number of animals | The OD value | Suppression ratio (%) |
| Model control group | 10 | 0.38±0.01 | |
| Vehicle group | 10 | 0.37±0.01 | 1.51 |
| Positive controls | 10 | 0.34±0.02** | 10.86 |
| Heavy dose of group | 10 | 0.33±0.02** | 11.99 |
| Middle dosage group | 10 | 0.34±0.02** | 9.99 |
| Small dose group | 10 | 0.35±0.02** | 8.72 |
Compare with model control group: * * P＜0.01
Table 6 result shows: big or middle two the dosage groups of traumatic pain cream can significantly suppress increasing of mouse skin capillary permeability that dimethylbenzene causes, with matched group significant difference (P＜0.05) are arranged relatively.
Conclusion: this experiment adopts 5 animal models such as microcirculation, antiinflammatory, pain relieving to inquire into the pharmacodynamic action of traumatic pain cream, and the result shows: the petty action of three all expansible mices of dosage group of traumatic pain cream ear, vein; The mice pain that Dichlorodiphenyl Acetate and hot plate cause has tangible analgesic effect; The mouse skin capillary permeability there is obvious inhibition; Rat cotton balls granuloma is formed with obvious inhibitory action and does not influence thymus and index and spleen index.Provide experimental basis for traumatic pain cream in clinical further application by this experiment.
Two, acute toxicity testing
1, material source
1.1 the preparation of ointment
As test one, the preparation method of 1.1 ointment in the main pharmacodynamics research.
1.2 laboratory animal source
New zealand rabbit, body weight 2.0～2.5kg, one-level, male and female half and half.Tonneau laboratory animal plant provides by the Haidian District, Beijing City, and the quality certification number is scxk (capital) 2000-0018.
2, method and result
2.1 zoodermic preparation: each animal is in spinal column both sides, preceding 24 hours backs of administration unhairing (use shears earlier, use depilatory then), and the unhairing area is the situation of inspection skin behind 10%, 24 hour of health.The damaged skin group dabs to oozing of blood degree of being with sand paper.
2.2 by being divided into grouping, each administration group is evenly smeared medicine at the depilation position with rabbit, the blank group is smeared water, and vehicle group is smeared excipient Oleum Sesami.6 hours once, smears altogether 2 times, and the coating position is with special immobilization with adhesive tape.The residual medicine of warm water flush away is used in administration after 24 hours.Observed 7 days continuously.
Observation index:
The variation of the general activity of animal, skin and hair, eye and mucosa after the observed and recorded administration, the irritant reaction that skin produced is judged its stimulus intensity by table 7 standards of grading.
Observe the poisoning manifestations of aspects such as breathing, central nervous system, extremity activity every day.
Write down the body weight of animal every day.
Table 7 skin irritation reaction standards of grading
Result of the test:
1) rabbit of accepting traumatic pain cream is at viewing duration, and general activity is normal, and fur is glossy, ingests, defecation is normal.
2) breathing, central nervous system, extremity activity do not show obvious acute toxic reaction.
3) do not find rabbit death in the observation period
4) local skin finding: control animals intact skin, damaged skin there is no erythema or edema; Three dosage treated animals of traumatic pain cream intact skin, damaged skin there is no erythema or edema, the results are shown in Table 8.
5) each administration group body weight gain and blank group compare there was no significant difference, the results are shown in Table 9.
Conclusion: traumatic pain cream 1g, 2g, 4g are applied in intact skin or damaged skin after the tame rabbit back unhairing respectively, 2 administrations in one day, the general state of animal, body weight, skin and hair, eye and mucosa, breathing, central nervous system, extremity activity do not show obvious acute toxic reaction, local skin is not had the obvious stimulation effect yet, therefore think that traumatic pain cream dermatologic is safe.
Table 8 traumatic pain cream is to rabbit skin acute toxicity test (Skin observing)
Table 9 traumatic pain cream is to the acute toxicity test of rabbit skin (body weight observation)
Three, long term toxicity test
1, material source
1.1 the preparation of ointment
As test one, the preparation method of 1.1 ointment in the main pharmacodynamics research.
1.2 laboratory animal source
Healthy new zealand rabbit, body weight 2.0～2.5kg, male and female half and half.The male and female sub-cage rearing, 2 in every cage is freely got food and is taken the photograph water.Raise under the environment of 20～22 ℃ of room temperatures.Concerted effort experimental animal plant provides by Beijing, the animal quality certification number: SCXK (capital) 2000-0018.
2, method and result
2.1, the test period, long term toxicity was got it more than 3 times, so be decided to be 4 weeks of successive administration, 2 weeks of convalescent period after the drug withdrawal according to 7 days courses of treatment of clinical trial.
2.2, dosage and grouping:
| Dosage | Number of animals | Intact skin | Damaged skin |
| Water | 6 | Blank | Blank |
| The excipient suitable with the heavy dose group | 6 | The excipient contrast | The excipient contrast |
| The 4g ointment | 10 | Heavy dose of group | Heavy dose of group |
| The 2g ointment | 10 | Middle dosage group | Middle dosage group |
| The 1g ointment | 10 | Small dose group | Small dose group |
2.3, zoodermic preparation: each animal is in spinal column both sides, preceding 24 hours backs of administration unhairing (use shears earlier, use depilatory then), and the unhairing area is that whether the situation of inspection skin normal behind 10%, 24 hour of health.The damaged skin group dabs to oozing of blood degree of being with sand paper.
2.4, with rabbit by above-mentioned design grouping, each treated animal male and female half and half, the administration group is evenly smeared medicine at the depilation position, the blank group is smeared water, vehicle group is smeared excipient.Once a day, the disposable immobilization with adhesive tape in coating position is smeared after 24 hours with smearing behind the residual medicine of warm water flush away at every turn again.In continuous 4 weeks, each group dissection 6 animal (male and female half and half) after the drug withdrawal continue to observe 4 animals of 2 weeks back dissection.
Observation index
1) ordinary circumstance: during the administration, situations such as the spirit of observed and recorded animal, activity, hair, feces.
2) observe the reaction of animal skin, mucosa every day, according to the form below is judged and the irritant reaction intensity and the irritated degree of record skin.
3) weigh weekly.
4) peripheral hemogram: survey peripheral hemogram, make leukocyte differential count.
5) biochemical indicator: survey serum ALT (ALT), aspartic acid aminotransferase (AST), blood urea nitrogen (BUN), creatinine (Crea), alkali phosphatase (ALP), total protein (TP), albumin (ALB), T-CHOL (T-CHO), glucose (GLU), total bilirubin (T-BIL).
6) important organ ponderal index
7) compare the t check between important organ histopathologic examination (attached pathological replacement and photochrome) employing group as a result and carry out statistical procedures.
Result of the test
1) during the administration, three dosage group rabbit general activitys, the mental status, hair, feces etc. show no obvious abnormalities.
2) body weight and body weight gain and blank group compare no significant difference (table 10,11);
Table 10 traumatic pain cream is to the influence of rabbit long term toxicity test body weight
Table 11 traumatic pain cream is to the influence of rabbit long term toxicity test weight gain value
3, peripheral hemogram comprises all fluctuations (table 12,13) in normal range of erythrocyte, leukocyte, hemoglobin, packed cell volume, platelet, leukocyte differential count;
Table 12 traumatic pain cream is to the influence of rabbit long term toxicity test hemogram (behind the medicine 1 month)
Table 13 traumatic pain cream is to the influence (convalescent period) of rabbit long term toxicity test hemogram
4) biochemical indicator comprises all fluctuations (table 14,15) in normal range of ALT, AST, BUN, Crea, ALP, TP, ALB, T-CHO, GLU, T-BIL;
Table 14 traumatic pain cream is to the influence of rabbit long term toxicity biochemical indicator (behind the medicine 1 month)
Table 15 traumatic pain cream is to the influence (convalescent period) of rabbit long term toxicity biochemical indicator
5) important organ comprises that the heart, liver, spleen, lung, kidney, thymus, adrenal gland, brain, uterus, ovary, testis, epididymis, prostatic weight coefficient compare there was no significant difference (table 16,17) with the blank group.
Table 16 traumatic pain cream is to the influence of rabbit long term toxicity organ index (behind the medicine 1 month)
Table 17 traumatic pain cream is to the influence (convalescent period) of rabbit long term toxicity organ index
6) skin does not have performances such as obvious redness, desquamation during the matched group of intact skin and the administration of three dosage groups of traumatic pain cream; The skin of individual animal is slightly rubescent during the matched group of damaged skin and the administration of three dosage groups of traumatic pain cream, does not have obvious edema, mainly occur in skin with Sandpapering after, after 2～3 days, take a turn for the better usually, be not that medicine causes (seeing Table 18,19).
Table 18 traumatic pain cream rabbit long term toxicity test skin conditions (intact skin group)
Table 19 traumatic pain cream rabbit long term toxicity test skin conditions (damaged skin group)
7) each main organs macroscopy is not seen pathological changes such as obvious enlargement, hyperemia, adhesion, necrosis.The agents area skin smooth, do not have red and swollen, no maculopapule, desquamation, coarse, non-pigment is calm;
8) histopathologic examination finds no because the change of drug-induced pathomorphology aspect.
Conclusion
Three dosage groups of traumatic pain cream are smeared rabbit intact skin and damaged skin, continuous 1 month, rabbit body weight, peripheral hemogram, ten biochemical indicators, organ index and mucocutaneous nothings are obviously influenced; The rabbit main organs does not have obvious drug-induced pathological change, illustrates that traumatic pain cream does not have obvious toxicity in institute's amount of reagent scope, is comparison safety.
Four, rabbit skin irritation test and Cavia porcellus allergic experiment
1, material source
1.1 the preparation of ointment
As test one, the preparation method of 1.1 ointment in the main pharmacodynamics research.
1.2 laboratory animal source
New zealand rabbit, body weight 2.0～2.5kg, one-level, male and female half and half.Cavia porcellus, one grade, body weight 250～300g, tonneau laboratory animal plant provides by the Haidian District, Beijing City, and the quality certification number is scxk (capital) 2000-0018.
2, method and result
2.1, rabbit single-dose skin irritation is tested
Test method:
2.1.1. zoodermic preparation: each animal is in spinal column both sides, preceding 24 hours backs of administration unhairing (use shears earlier, use depilatory then), and the unhairing area is the situation of inspection skin behind 10%, 24 hour of health.The damaged skin group dabs to oozing of blood degree of being with sand paper.
2.1.2. the contrast of consubstantiality left and right sides self is adopted in test, divides intact skin group and damaged skin group.8 of every group of rabbit, left side, unhairing place is coated with traumatic pain cream 1g, and the right side is coated with excipient in contrast, every animal sub-cage rearing.Smear and use warm water flush away left drug after 24 hours, write down respectively and smeared the position skin conditions in 1,24,48,72 hour.
Result of the test: viewing duration intact skin group, damaged skin treated animal control sides and administration side there is no erythema or edema.The results are shown in Table 20.
Table 20 traumatic pain cream is to rabbit skin irritant test (single-dose)
2.2, rabbit multiple dosing skin irritation is tested
Test method: step is with an administration.Smeared administration continuously 7 days, and observed a week after the drug withdrawal,, also observe and smear the position whether pigmentation, petechia, situations such as pachylosis are arranged except that observing and the erythema of record every day and edema situation mark.
Result of the test: the intact skin winding is subjected to the rabbit of traumatic pain cream to there is no erythema or edema in whole viewing duration control sides and administration side; The damaged skin treated animal is visible slight rubescent at cut from administration the 4th day beginning control sides and administration side, alleviates day by day after the drug withdrawal, observes on the 7th day to drug withdrawal that all animals all recover when finishing; All animals are smeared position skin and are not seen pigmentation, phenomenons such as petechia, pachylosis.The results are shown in Table 21.
Table 21 traumatic pain cream is to rabbit skin irritant test (multiple dosing)
Five, traumatic pain cream is to the guinea pig skin hypersensitive test
1. skin is prepared: each animal is in spinal column both sides, preceding 24 hours backs of administration unhairing (use shears earlier, use depilatory then), and the unhairing area is the situation of inspection skin behind 10%, 24 hour of health.
2. grouping: Cavia porcellus is divided into 3 groups at random by body weight, and 10 every group, male and female are traumatic pain cream group for half and half, the first group, and second group is the excipient matched group, and the 3rd group is the sensitizing agent matched group.
3. sensitization contact: get and tried thing 0.2g and spread upon depilation district, Cavia porcellus left side, special immobilization with adhesive tape kept 6 hours.Smeared once in the 7th day, the 14th day again, and amounted to 3 times, positive sensitizer group smears 1%2, the 4-dinitrochlorobenzene, and the excipient matched group is smeared excipient under square one.
4. excite contact: after last administration sensitization 14 days, to be tried thing 0.2g and be smeared depilation district, guinea pig back right side, positive control is with 0.1%2, the 4-dinitrochlorobenzene, removing medicine after 6 hours observes at once, observed the skin allergy situation then once more in 24,48,72 hours, according to the form below standards of grading [2] and sensitization incidence rate are inferred sensitization, being calculated as of sensitization incidence rate: the animal example number (no matter degree weight) that skin erythema, edema or systemic anaphylaxis will occur, divided by the animal subject sum, i.e. sensitization incidence rate.
The standards of grading of skin allergy degree and evaluation criterion
Experimental result:
Each treated animal activity of experimental session freely, defecation is normal, no astasia, General Symptomies such as asthma, shock.
2. local skin finding: red swelling of the skin and other anaphylaxiss take place in traumatic pain cream and water matched group Cavia porcellus all none example; Positive control drug 2,10 Cavia porcelluss of 4-dinitrochlorobenzene group are after the 3rd sensitization, and sensitization place skin begins to occur erythema and edema, formed moderate erythema and edema before the excitability contact, the sensitization rate is 100%, and symptom lasts till observes end (exciting back 72 hours).The results are shown in Table 22
3. guinea pig skin hypersensitive test body weight is not had obvious influence, the results are shown in Table 23
Table 22 traumatic pain cream is to the hypersensitive test of guinea pig skin
Table 23 traumatic pain cream is to the hypersensitive test (body weight) of guinea pig skin
Conclusion:
1, after once being smeared or repeatedly smear rabbit intact skin and damaged skin, traumatic pain cream 1g all do not cause tangible stimulation.
2, traumatic pain cream does not cause tangible anaphylaxis after being applied in guinea pig skin.
Compared with prior art, the present invention is that raw material is formed with common Cortex Moutan, Radix Dipsaci, Radix Clematidis etc., and formula for a product derives from the secret recipe that the Seedling doctor passes on from generation to generation, and through the special process elaborate of Seedling man, has antiinflammatory, detumescence, analgesic effect.Formula for a product constitutes fairly simple, product quality is more easy to control, crude drug obtains its effective ingredient through extraction to be made its easier absorption and brings into play drug effect, better improves the therapeutic effect of medicine of the present invention, thereby a kind of Chinese medicine for outer use that can more effectively treat traumatic pain is provided.The preparation method of Chinese medicine preparation of the present invention is simple, constant product quality, not the ixoderm skin, need not heat, have no side effect nonirritant, non-sensitization, but clinical life-time service, for the patient provides the external used medicine of low, the eutherapeutic treatment traumatic pain of a kind of drug cost, enriched market, the medication that has increased the patient is selected.
The specific embodiment
Embodiment 1: the preparation method of external use plaster of the present invention
Getting Olibanum 280g and Myrrha 280g, to be ground into granularity be 100 purpose fine powders, with its mix homogeneously, the A product are standby; Get Cortex Moutan 160g pulverizing and be granularity 100 purpose fine powders, it is standby to get the B product; Get Radix Dipsaci 160g and Radix Clematidis 260g and pulverize, put into 90 ℃ Oleum Sesami 420g, flood after 3 hours with 100 order stainless steel sift net filtrations to coarse powder, filtering residue discard need not, in filtrate, add and smash
Broken Semen Momordicae 120g and Semen Ricini 120g filter after 3 hours once more in 90 ℃ of dippings, filtering residue (Semen Momordicae behind the dipping and Semen Ricini) is sent into the interior making beating of beater and is made oily slurry through 100 order stainless steel sift net filtrations, the oil slurry is that the C product are standby, and filtrate is medicine oil.Taking by weighing an amount of Cera Flava (gross weight of Cera Flava, A product, B product, C product and medicine oil is 2300g) makes it to be fused in 90 ℃ the medicine oil, stir after adding A product and C product then, treating to add when temperature is chilled to 80 ℃ the B product stirs, make the uniform circular cream sheet of thickness with pelleter after being chilled to room temperature, place in the medical air-permeable adhesive tape, packing promptly makes external use plaster of the present invention.
Character: this product is the circular cream sheet of black, glossy exquisiteness, non-trimming breach, feeble QI perfume (or spice).
Function cures mainly: blood circulation promoting and blood stasis dispelling, reducing swelling and alleviating pain, strengthening the tendons and bones.Cure mainly congestion resistance network card, acute and chronic soft tissue injury person.
Usage and dosage: external, the injury is cleaned and is dried, and plaster and release paper are separated, and aims at sore spot then and pastes the jail, changes dressings cream once in 24 hours, and 7 days is a course of treatment.
Points for attention: the careful usefulness of allergy sufferers, contraindication in pregnancy is forbidden taking orally.There is the skin wound bleeder to stick.
Specification: 2.3g/ sheet.
Storage: sealing, put dry place.
Effect duration: tentative 24 months.
Embodiment 2: the preparation method of externally applied ointment of the present invention
Get Olibanum 260g and Myrrha 260g is ground into fine powder, mix homogeneously, the A product are standby; Get Cortex Moutan 140g pulverizing and be fine powder, it is standby to get the B product; Get the Oleum Sesami 500g that Radix Dipsaci 180g and Radix Clematidis 280g put into 80 ℃, flood 4 hours after-filtration, filtering residue discards need not, adding Semen Momordicae 140g and Semen Ricini 140g in filtrate filters after 4 hours once more in 80 ℃ of dippings, oily slurry is made in the filtering residue making beating, and it is standby to get the C product, and filtrate is medicine oil.Take by weighing an amount of Cera Flava (gross weight of Cera Flava, A product, B product, C product and medicine oil is 2300g) and make it to be fused in 80 ℃ the medicine oil, add A product, B product and C product then and stir, be chilled to after the room temperature routinely preparation process and make unguentum.
Embodiment 3: the preparation method of external use plaster of the present invention
Getting Olibanum 300g and Myrrha 300g, to be ground into granularity be 100 purpose fine powders, with its mix homogeneously, the A product are standby; Get Cortex Moutan 180g pulverizing and be granularity 100 purpose fine powders, it is standby to get the B product; Getting Radix Dipsaci 140g and Radix Clematidis 240g pulverizes and to be coarse powder, put into 100 ℃ Oleum Sesami 400g, flood after 2.5 hours with 100 order stainless steel sift net filtrations, filtering residue discards need not, adding the Semen Momordicae 100g and the Semen Ricini 100g that smash to pieces in filtrate filters after 2.5 hours once more in 100 ℃ of dippings, filtering residue (Semen Momordicae behind the dipping and Semen Ricini) is sent into the interior making beating of beater and is made oily slurry through 100 order stainless steel sift net filtrations, and oily slurry is that the C product are standby, and filtrate is medicine oil.Take by weighing an amount of Cera Flava (gross weight of Cera Flava, A product, B product, C product and medicine oil is 2300g) and make it to be fused in 100 ℃ the medicine oil, stir after adding A product and C product then, treat to add when temperature is chilled to 80 ℃ the B product and stir,
Make the uniform circular cream sheet of thickness with pelleter after being chilled to room temperature, place in the medical air-permeable adhesive tape, packing promptly makes external use plaster of the present invention.
Claims (4)
1. Chinese medicine for outer use for the treatment of traumatic pain, it is characterized in that: according to listed as parts by weight, it is to be prepared from for 20～25 parts by 7～9 parts of Cortex Moutans, 7～9 parts of Radix Dipsacis, 13～15 parts of Olibanums, 13～15 parts of Myrrhas, 12～14 parts of Radix Clematidis, 5～7 parts of Semen Momordicaes, 5～7 parts of Semen Ricini and Oleum Sesami.
2. according to the Chinese medicine for outer use of the described treatment traumatic pain of claim 1, it is characterized in that: according to listed as parts by weight, it is to be prepared from for 21 parts by 8 parts of Cortex Moutans, 8 parts of Radix Dipsacis, 14 parts of Olibanums, 14 parts of Myrrhas, 13 parts of Radix Clematidis, 6 parts of Semen Momordicaes, 6 parts of Semen Ricini and Oleum Sesami.
3. the preparation method of the Chinese medicine for outer use of treatment traumatic pain as claimed in claim 1 or 2 is characterized in that: get Olibanum and Myrrha is ground into fine powder, mix homogeneously, the A product are standby; Get Cortex Moutan and be ground into fine powder, it is standby to get the B product; Get Radix Dipsaci and Radix Clematidis and put into 80～100 ℃ Oleum Sesami, flood 2.5～4 hours after-filtration, filtering residue discards need not, adding Semen Momordicae and Semen Ricini in filtrate filters after 2.5～4 hours once more in 80～100 ℃ of dippings, oily slurry is made in the filtering residue making beating, it is standby to get the C product, filtrate adds Cera Flava and makes it fusing under 80～100 ℃ of conditions, add the A product then and the C product stir, treat to add when temperature is chilled to 80 ℃ the B product, stir, be chilled to after the room temperature routinely preparation process and make various exterior-applied formulations.
4. according to the preparation method of the Chinese medicine for outer use of the described treatment traumatic pain of claim 3, it is characterized in that: getting Olibanum and Myrrha, to be ground into granularity be 100 purpose fine powders, mix homogeneously, the A product are standby; Get the Cortex Moutan pulverizing and be granularity 100 purpose fine powders, it is standby to get the B product; Get Radix Dipsaci and Radix Clematidis and put into 90 ℃ Oleum Sesami, flood 3 hours after-filtration, filtering residue discards need not, adding Semen Momordicae and Semen Ricini in filtrate filters after 3 hours once more in 90 ℃ of dippings, oily slurry is made in the filtering residue making beating, it is standby to get the C product, filtrate adds Cera Flava and makes it fusing under 90 ℃ of conditions, add the A product then and the C product stir, add the B product when treating that temperature is chilled to 80 ℃, stir, make the uniform circular cream sheet of thickness with pelleter after being chilled to room temperature, place in the medical air-permeable adhesive tape, make external use plaster.
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| 中西医结合治疗外伤性髌骨脱位. 曹廷生等.中医正骨，第19卷第2期. 2007 |
| 中西医结合治疗外伤性髌骨脱位. 曹廷生等.中医正骨，第19卷第2期. 2007 * |
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