The specific embodiment
Below further set forth the beneficial effect of medicine of the present invention by clinical experiment.
Medicinal plaster treatment acute soft tissue injury of the present invention clinical trial is summed up:
Medicinal plaster of the present invention is Shenyang Chinese Medicine Pharmaceutical Co., Ltd's development, this medicine is made up of Radix Notoginseng, the Radix Angelicae Dahuricae, Eupolyphaga Seu Steleophaga, Rhizoma Chuanxiong, Radix Angelicae Sinensis, Flos Carthami, Borneolum Syntheticum, Camphora, methyl salicylate, Mentholum, Semen daturae fluid extract, chondroitin sulfate, diphhydramine hydrochloride, dimethyl sulfoxide Chinese medicine, has blood circulation and promoting silt, the function of pain relieving tissue regeneration promoting is mainly used in diseases such as the acute and chronic soft tissue injury of treatment.Clinical trial is adopted and is contrasted non-blind method at random, and my institute observes 60 examples altogether, and wherein 30 examples are organized in treatment, matched group 30 examples.The total effective rate 93.00% of treatment group, cure-remarkable-effectiveness rate 70.00%; Matched group total effective rate 86.67%, cure-remarkable-effectiveness rate 53.33%.
This institute has case all to derive from the out-patient, and case all meets diagnostic criteria, the harmony of two groups the state of an illness, conditions of patients distribute go up, age distribution all have comparability before the distributing equilibrium comparison of two groups of patient's courses of disease, two groups of treatments.
Research method
One, case is selected:
(1) diagnostic criteria: formulate with reference to " the clinical guidance principle of new Chinese medicine treatment acute soft tissue injury ".
1. Western medicine diagnose standard
(1) soft tissue contusion
1) tangible trauma history is arranged, sharp ache, local swelling rapidly, limbs disturbance.
2) the injury tenderness is obvious, the cyanosis of the skin ecchymosis can occur, and ecchymosis can appear in severe patient, and fluctuation is positive.
3) after 2 weeks of damage, the congestive edema major part disappears, and ecchymosis transfers yellowish-brown to, and pain fades away, the slight obstacle of function.
4) small number of patients convalescent period long, the part still has swelling, or scleroma is arranged, indistinct pain, limb activity is limited, protracted course of disease can become chronic injury at last.
5) X ray examination: be mainly used in and check that the injury has or not fracture, dislocation and osteopathia etc., sometimes tendon, ligament and cartilage injury are had certain reference value.
(2) articular sprain
1) early stage: obvious articular sprain history is arranged, hinder the back sharp ache, swelling, ecchymosis appear rapidly in the part, the joint movement function obstacle.
2) mid-term: after injured 3~4 days, swelling begins to disappear, and ecchymosis transfers livid purple color to, the skin temperature height, pain decrescence, joint movement function is still limited.
3) later stage: articular sprain is after two weeks, and the congestive edema major part disappears, and ecchymosis transfers yellowish-brown to, and pain is eliminated gradually, and funtion part is recovered.Small number of patients convalescent period is long, and the part still has swelling, or scleroma is arranged, and has a dull ache, and joint motion is limited, protracted course of disease.
4) X ray examination: be mainly used in the Differential Diagnosis of illness such as fracture, dislocation and osteopathia, sometimes tendon, ligament and cartilage injury had certain reference value.
2. Chinese medical discrimination
It is early stage that the syndrome of qi stagnation and blood stasis pilosity is born in damage, and swollen shape is arranged outward, twinge, and localized pain can livid purple ecchymosis or hematoma occur in the injury, and joint motion is limited, purplish tongue or ecchymosis is arranged, stringy and hesitant pulse.
(2), symptom: sign scoring system and severity extent grade scale
Formulate this standard with reference to treatment acute soft tissue injury disease in " new Chinese medicine clinical guidance principle ".
(3) test case standard
1. include the case standard in
Meet acute soft tissue injury diagnostic criteria and differential diagnosis in tcm, the course of disease is no more than 3 days persons, can include the test case in.
2. get rid of case standard (comprising inadaptation or rejecting standard)
(1) age is at under-18s or over-65s, gestation or women breast-feeding their children, allergic constitution or to this medicine allergy sufferers.
(2) soft tissues such as fracture or muscle, tendon, ligament have fracture person fully.
(3) be associated with serious primary disease such as cardiovascular, cerebrovascular, liver, kidney and hemopoietic system, psychotic.
(4) do not meet the standard of including in, not medication in accordance with regulations can't be judged curative effect, or data is not congruent affects the treatment or safety judgement person.
Slightly: symptom and sign integration~10 minute
Moderate: symptom and sign integration~15 minute
Severe: symptom and sign integration~20 minute
Two, test method:
(1) group technology: be divided into treatment group and matched group according to the random table method.Treatment group 30 examples and matched group 30 examples adopt the non-blind method that contrasts at random.
(2) Therapeutic Method: adopt non-blind method.
1. treatment group medicine: medicinal plaster of the present invention each 1 pastes (each position), every day 1 time, external application.
2. matched group medicine: SHENYANG HONGYAO PIAN, each 6, every day three times, oral.
(3) course of treatment: 7 days is a course of treatment, observes two courses of treatment.
(4) observation index
1. health giving quality observation
(1) situation of change before and after clinical symptoms, the sign treatment;
(2) situation of change before and after picture of the tongue, the pulse condition treatment.
2. safety detects:
1. general health check-up project.
2. blood, urine, just routine test.
3. the heart, liver, renal function chemical examination.
4. keep a close eye on skin allergy and other untoward reaction.
(5) should control variable factor from following several respects strictness to clinic case:
1. before clinical trial began, the clinicist that tissue is participated in clinical trial studied hard clinical trial protocol, implements every technical specification.
2. participate in doctor's relative fixed of clinical trial.
3. patient should be by the requirement further consultation of observation plan, fails further consultation on time as patient, and the doctor should in time notify its further consultation or follow up a case by regular visits to.
Three, curative effect judging standard:
Efficacy assessment standard with reference to treatment acute soft tissue injury in " new Chinese medicine clinical guidance principle " is formulated this standard.
Therapeutic outcome
One, two groups of total effectses relatively
Table 1 liang group total effects relatively
Group |
The example number |
Recovery from illness N(%)
|
Produce effects N(%)
|
Effectively N(%)
|
Invalid N(%)
|
Cure-remarkable-effectiveness rate % |
Total effective rate % |
Treatment group matched group |
30 30 |
10(33.3) 9(30) |
11(36.7) 7(23.3) |
7(23.3) 10(43.3) |
2(6.7) 4(3.3) |
70.00 53.33 |
93.00 86.67 |
By table 1 as seen, the treatment group obvious effective rate of healing is 70.00%, and total effective rate is 93.00%, and the obvious effective rate of matched group is 53.33%, and total effective rate is 86.67%.
Two, two groups of every symptoms, sign curative effects compare
The table 2 liang every symptom of group, sign curative effect are relatively
Symptom and sign |
Group |
The example number |
Before the treatment |
After the treatment |
In the group |
+++ |
++ |
+ |
- |
+++ |
++ |
+ |
- |
U |
P |
Pain tenderness swelling color of the leather dysfunction position |
Smelting treatment group treatment of control group group treatment of control group group treatment of control group group treatment of control group group treatment of control group group control group |
30 30 30 30 30 30 30 30 30 30 30 30 |
6 12 7 16 2 1 4 1 2 4 1 0 |
24 17 23 14 21 14 18 13 13 17 2 3 |
0 1 0 0 6 12 5 12 15 9 27 27 |
0 0 0 0 1 3 3 4 0 0 0 0 |
0 0 0 0 0 0 0 0 0 0 0 0 |
1 3 3 0 0 0 0 0 1 0 0 0 |
5 13 11 18 7 6 8 8 5 17 19 23 |
24 14 16 12 23 24 22 22 24 13 11 7 |
6.53 6.19 6.19 6.71 6.12 5.37 5.56 4.86 5.83 5.57 2.88 2.08 |
<0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.05 |
Pain: U=2.25 P<0.05
Tenderness: U=0.49 P>0.05
Swelling: U=0.22 P>0.05
Color of the leather: U=0 P>0.05
Dysfunction: U=2.33 P<0.05
Position: U=0.89 P>0.05
As shown in Table 2, three's symptom, sign all have clear improvement behind two groups of patient treatments, compare in the group before and after the treatment, and difference P<0.01 and P<0.05 of highly significant is all arranged.Carry out between two groups treatment back curative effect more relatively, two groups have significant difference P<0.05 on to pain and handicapped improvement, to two groups of there was no significant difference P>0.05 of improvement of other symptoms, sign.
Three, the comparison of two groups of treatment back analgesic times
The comparison of table 3 liang group treatment back analgesic time (my god)
Index |
Group |
The example number |
X±S |
t |
p |
|
Treatment group matched group |
30 30 |
2.03±1.68 5.30±3.22 |
2.362 |
<0.01 |
As shown in Table 3, two groups have significant difference P<0.01 on analgesic time
The relation of four, the treatment group state of an illness and total effects
The relation of the table 4 treatment group state of an illness and total effects
The state of an illness |
The example number |
Recovery from illness Produce effects Effectively Invalid N(%) N(%) N(%)
|
Cure-remarkable-effectiveness rate N (%) |
Total effective rate (%) |
Slight moderate severe |
7 22 1 |
4 6 0 |
1 10 0 |
2 4 1 |
0 2 0 |
71.4 72.7 0 |
100 90.9 100 |
Ridit analyzes: X
2=2.0316 P>0.05
As shown in Table 4,7 examples that the state of an illness is slight, total effective rate 100%; State of an illness moderate 22 examples, total effective rate are 90.9%; Severe 1 example, total effective rate are 100%.Analyze treatment through Ridit and organize different state of an illness there was no significant difference P>0.05 on curative effect.
The relation of five, treatment group sex and curative effect
The relation of table 5 treatment group sex and curative effect
Sex |
The example number |
Recovery from illness N(%)
|
Produce effects N(%)
|
Effectively N(%)
|
Invalid N(%)
|
Cure-remarkable-effectiveness rate (%) |
Total effective rate (%) |
The men and women |
14 16 |
3(21.4) 7(43.8) |
6(42.9) 5(31.3) |
4(28.6) 3(18.8) |
1(7.1) 1(6.25) |
64.29 75 |
92.9 93.75 |
Ridit analyzes: u=1.06 P>0.05
As shown in Table 5, male's 14 examples, total effective rate 92.9%, women's 16 examples, total effective rate is 93.75%.Analyze treatment group different sexes there was no significant difference P>0.05 on curative effect through Ridit.
The relation of six, treatment group age and curative effect
Table 6 treatment group age and therapeutic effect relationship
Age (year) |
The example number |
Recovery from illness N(%)
|
Produce effects N(%)
|
Effectively N(%)
|
Invalid N(%)
|
Cure-remarkable-effectiveness rate (%) |
Total effective rate (%) |
~30 ~45 ~65 |
6 17 7 |
3(50) 4(23.5) 3(42.9) |
2(33.3) 8(47.1) 1(1413) |
1(16.7) 4(23.5) 2(28.6) |
0 1(5.9 ) 1(14.3) |
83.33 70.58 57.14 |
100 94.12 85.71 |
Ridit analyzes: X
2=1.067 P>0.05
As shown in Table 6, age~30 year old 6 examples, total effective rate 100%: age~45 year old 17 examples, total effective rate is 94.12%; Age~65 year old 7 examples, total effective rate is 85.71%.Analyze treatment group all ages and classes there was no significant difference P>0.05 on curative effect through Ridit.
Safety detects:
To treatment group and matched group patient, carried out respectively before and after the treatment there is no abnormal change before and after routine blood test, routine urinalysis, liver function, renal function, the Electrocardiographic inspection treatment in the clinical experiment.See table 7 for details.
(N) looked in safety procuratorial work before and after the table 7 treatment group
Project |
The example number |
Before the treatment |
After the treatment |
Normally |
Unusually |
Normally |
Unusually |
The routine blood test routine urinalysis |
30 30 |
30 30 |
0 0 |
30 30 |
0 0 |
Just conventional GPT BUN Cr electrocardiogram |
30 30 30 30 15 |
30 30 30 30 14 |
0 0 0 0 1 |
30 30 30 30 14 |
0 0 0 0 1 |
Untoward reaction:
In 60 routine observation groups, there is 1 example slight gastrointestinal irritation symptom to occur in the matched group, without any processing, the back irritation that continues to take medicine disappears; In security inspection, the treatment group has the preceding myocardium mild cerebral ischemic of 1 example treatment, treats the back and does not have obviously improvement.Carried out before and after the treatment blood, urine, just, liver, renal function detect all in normal range.Other untoward reaction do not appear yet.
Discuss:
Medicinal plaster of the present invention is 70% to the more obvious effective rate of acute soft tissue injury, and total effective rate is 93.00%, and the matched group obvious effective rate of healing is 53.3%, and total effective rate is 86.67%.Medicinal plaster of the present invention is to the various symptoms that acute soft tissue injury occurred, and sign all improves significantly, and compares with matched group, improves pain and handicapped symptom is better than matched group.More rapid-action than matched group SHENYANG HONGYAO PIAN in the alleviation of medicinal plaster of the present invention to acute soft tissue injury pain, two groups have significant difference.Medicinal plaster of the present invention is not found obvious toxic and side effects and untoward reaction clinically.
Conclusion:
Medicinal plaster of the present invention can be treated the qi stagnation and blood stasis type acute soft tissue injury significantly, especially directly acts on the part owing to it aspect pain relieving, and analgesic effect is fast and good.
The clinical trial of medicinal plaster treatment chronic soft tissue injuries of the present invention is summed up:
Medicine of the present invention is Shenyang Chinese Medicine Pharmaceutical Co., Ltd's development, has blood circulation and promoting silt, and the function of pain relieving tissue regeneration promoting is mainly used in the acute and chronic soft tissue injury disease of treatment.My institute is responsible for this medicine has been carried out clinical verification, mainly investigates its curative effect and untoward reaction.Non-at random blind method is adopted in clinical trial, and my institute observes 110 examples altogether, and wherein 80 examples are organized in treatment, matched group 30 examples.The total effective rate 90% of treatment group, cure-remarkable-effectiveness rate 60.00%; Matched group total effective rate 80%, cure-remarkable-effectiveness rate 46.67%.
Physical data:
This institute has case all to derive from my outpatient of institute, and strict control variable factor, and case all meets the case choice criteria.
One, test case standard
1, include the case standard in: meet chronic soft tissue injuries diagnostic criteria and differential diagnosis in tcm, the course of disease is no more than 3 days persons, can include the test case in.
2, remove case standard (comprising inadaptation or rejecting standard).
Age is at under-18s or over-65s, gestation or women breast-feeding their children, allergic constitution or to this medicine allergy sufferers.Soft tissues such as fracture or muscle, tendon, ligament have fracture person fully.Be associated with serious primary disease such as cardiovascular, cerebrovascular, liver, kidney and hemopoietic system, the psychotic.Do not meet the standard of including in, not medication in accordance with regulations can't be judged curative effect, or data is not congruent affects the treatment or safety judgement person.
Slightly: symptom and sign integration~10 minute; Moderate: symptom and sign integration~15 minute; Severe: symptom and sign integration~20 minute.
Two, test method:
Group technology: be divided into treatment group and matched group according to the random table method.Treatment group 80 examples and matched group 30 examples.
Therapeutic Method: adopt non-at random blind method.
Treatment group medicine: medicinal plaster of the present invention each 1 pastes (according to the position, paste at each position one) every day 1 time, external application.
The matched group medicine: SHENYANG HONGYAO PIAN, each 6, every day three times, oral.
The course of treatment: 14 days is a course of treatment, all observes a course of treatment.
Result of the test:
One, two groups of total effectses relatively
Table 1 liang group total effects relatively
Group |
The example number |
Recovery from illness N(%)
|
Produce effects N(%)
|
Effectively N(%)
|
Invalid N(%)
|
Cure-remarkable-effectiveness rate % |
Total effective rate % |
The treatment group |
80 |
15(18.75) |
33(41.25) |
25(28.75) |
7(11.25) |
60.00 |
90 |
Matched group |
30 |
4(13.33) |
10(33.33) |
10(40.00) |
6(13.34) |
46.67 |
80 |
By table 1 as seen, the treatment group obvious effective rate of healing is 60.00%, and total effective rate is 90%, and the obvious effective rate of matched group is 46.67%, and total effective rate is 80%.
Two, two groups of every symptoms, sign curative effects compare
The table 2 liang every symptom of group, sign curative effect are relatively
Symptom and sign |
Group |
Example |
Before the treatment |
After the treatment |
In the group |
Pain tenderness swelling color of the leather abnormal function obstacle position |
Treatment group treatment of control group group treatment of control group group treatment of control group group treatment of control group group treatment of control group group control group |
Number |
+++ |
++ |
+ |
- |
+++ |
++ |
+ |
- |
U |
P |
80 30 80 30 80 30 80 30 80 30 80 30 |
18 7 26 9 1 0 1 0 1 0 0 0 |
56 20 46 16 36 12 23 5 42 18 9 3 |
6 3 8 5 29 9 18 8 37 12 71 27 |
0 0 0 0 14 9 38 17 0 0 0 0 |
0 1 1 1 0 0 0 0 0 0 0 0 |
2 3 7 3 0 0 0 0 8 2 2 2 |
20 12 26 17 7 3 5 4 20 12 58 22 |
58 14 46 9 73 27 75 26 52 16 20 6 |
10.52 5.46 9.63 5.11 8.52 4.29 5.27 2.16 8.10 5.01 3.39 1.43 |
<0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.05 <0.01 <0.01 <0.01 >0.05 |
Ridit analyzes: between group:
Pain: U=2.29 P<0.05
Tenderness: U=2.13 P<0.05
Swelling: U=0.10 P>0.05
Color of the leather: U=0.57 P>0.05
Dysfunction: U=0.76 P>0.05
Position: U=0.65 P>0.05
As shown in Table 2, symptom, sign all have and obviously alleviate and improve behind two groups of patient treatments, compare in the group before and after the treatment, difference P<0.01 and P<0.05 that highly significant is all arranged, carry out again treating the back curative effect between two groups relatively, two groups have significant difference P<0.05 on to the improvement of pain and tenderness, to two groups of there was no significant difference P>0.05 of improvement of other symptoms, sign.
Three, the comparison of two groups of treatment back analgesic times
The comparison of table 3 liang group treatment back pain relieving onset time (my god)
As shown in Table 3, two groups have significant difference P<0.01 on analgesic time.
Safety detects:
To treatment group and matched group patient, carry out routine blood test, routine urinalysis, liver function, renal function, Electrocardiographic inspection before and after the treatment respectively in the clinical experiment, there is no abnormal change before and after the treatment.
Discuss:
1. medicinal plaster of the present invention is 60% to the more obvious effective rate of chronic soft tissue injuries, and total effective rate is 90%; The matched group obvious effective rate of healing is 46.67%, and total effective rate is 80%; Medicinal plaster of the present invention is to the various symptoms that chronic soft tissue injuries occurred, and sign improves significantly before and after treatment, compare with matched group, improve pain, the tenderness symptom is better than matched group; Medicinal plaster of the present invention to chronic soft tissue injuries on pain relieving onset time, obviously faster than matched group; Medicinal plaster of the present invention is not found other toxic and side effects and untoward reaction clinically.
Conclusion:
Medicinal plaster of the present invention is 18.75% to the cure rate of chronic soft tissue injuries, and obvious effective rate is 60.00% total effective rate 90%, on pain relieving onset time obviously faster than matched group.And be medicine for external use, directly act on stasis of blood affected part, except that only a few has allergic phenomena, do not see other toxicities, safe and reliable.
Medicinal plaster of the present invention is to the pharmacodynamics test data of difference prescription content:
Medicinal plaster of the present invention is made up of Chinese medicines such as Radix Notoginseng, Eupolyphaga Seu Steleophaga, Flos Carthami, the Radix Angelicae Dahuricae, Rhizoma Chuanxiong, Radix Angelicae Sinensis, Borneolum Syntheticum, Camphoras.But external application spreads on pain affected part blood circulation and promoting silt, pain relieving tissue regeneration promoting.Clinically be used for that traumatic injury, muscles and bones swell and ache, the far and near stasis of blood is suffered from.Cure mainly according to its function, we are by having carried out pharmacodynamic experiment with hemorheology of rat is tested to the different prescription of medicinal plaster of the present invention content to the zoopery of rat local wound ecchymosis.
Experiment purpose: cure mainly relevant pharmacological action with function with zoopery means check medicinal plaster of the present invention.
The medicine grouping: medicinal plaster of the present invention is provided by Shenyang Chinese Medicine Pharmaceutical Co., Ltd.Its drug test grouping: 14 flavor Chinese medicine different contents prescriptions in the prescription are divided into 5 groups of methods by embodiment one make plaster and test.
(1) Radix Notoginseng 870g Radix Angelicae Dahuricae 200g Eupolyphaga Seu Steleophaga 200g Rhizoma Chuanxiong 200g Radix Angelicae Sinensis 150g Flos Carthami 150g Borneolum Syntheticum 25g Camphora 25g methyl salicylate 35g Mentholum 60g Semen daturae fluid extract 60g chondroitin sulfate 3g diphhydramine hydrochloride 8g dimethyl sulfoxide 60g
(2) Radix Notoginseng 600g Radix Angelicae Dahuricae 155g Eupolyphaga Seu Steleophaga 155g Rhizoma Chuanxiong 155g Radix Angelicae Sinensis 155g Flos Carthami 155g Borneolum Syntheticum 45g Camphora 45g methyl salicylate 65g Mentholum 95g Semen daturae fluid extract 95g chondroitin sulfate 20g diphhydramine hydrochloride 20g dimethyl sulfoxide 95g
(3) Radix Notoginseng 750g Radix Angelicae Dahuricae 175g Eupolyphaga Seu Steleophaga 175g Rhizoma Chuanxiong 175g Radix Angelicae Sinensis 175g Flos Carthami 175g Borneolum Syntheticum 35g Camphora 35g methyl salicylate 50g Mentholum 80g Semen daturae fluid extract 80g chondroitin sulfate 10g diphhydramine hydrochloride 12.5g dimethyl sulfoxide 80g
(4) Radix Notoginseng 800g Radix Angelicae Dahuricae 180g Eupolyphaga Seu Steleophaga 180g Rhizoma Chuanxiong 180g Radix Angelicae Sinensis 180g Flos Carthami 180g Borneolum Syntheticum 40g Camphora 40g methyl salicylate 55g Mentholum 85g Semen daturae fluid extract 85g chondroitin sulfate 14g diphhydramine hydrochloride 14g dimethyl sulfoxide 85g
(5) Radix Notoginseng 600g Radix Angelicae Dahuricae 160g Eupolyphaga Seu Steleophaga 160g Rhizoma Chuanxiong 150g Radix Angelicae Sinensis 150g Flos Carthami 160g Borneolum Syntheticum 20g Camphora 20g methyl salicylate 35g Mentholum 95g Semen daturae stream soaks
Cream 95g chondroitin sulfate 20g diphhydramine hydrochloride 20g dimethyl sulfoxide 95g
Laboratory animal: the Wistar rat is all purchased the Experimental Animal Center in Chinese Medical Sciences University, the quality certification number: distant essence is closed word No. 008.Pellet is purchased in Shenyang laboratory animal feed factory.
One, medicinal plaster of the present invention is to the influence of the traumatic ecchymosis in part
[1]
Experimental technique and result:
Get 50 of above-mentioned rats, be divided into 5 groups at random, used 8%Na in preceding 24 hours in experiment
2S removes rat back Mus hair, 5 * 4cm
2With tiger clamp rat depilation district skin, to cause subcutaneous hemorrhage degree of being, area is 4 * 3cm
2Each group sticks administration.Medicinal plaster dosage of the present invention is the said medicine grouping.Be administered once every day, and successive administration 5 days with touching and perusal swelling and the ecchymosis situation that disappears, and is measured residual area during the every day administration, keep the score by table 1, and be its ecchymosis order of severity index with its total points, result's usefulness Mann Whitney inspection.See Table 2.
The standards of grading of the traumatic ecchymosis of table 1
Ecchymosis changes |
Integration |
0 |
1 |
2 |
3 |
Edema ecchymosis color and luster ecchymosis area |
Do not have |
Visible reluctantly slight erythema<3cm
2 |
The cutaneous protuberance profile is known moderate erythema<9cm
2 |
The edema about 1mm aubergine of protuberance also has burnt stasis of blood formation 〉=9cm
2 |
Table 2, to the influence of the traumatic ecchymosis of rat (X ± SD)
Group |
Number of animals |
Medicine ecchymosis integration |
Only |
1 day |
2 days |
3 days |
4 days |
5 days |
Test 1 group |
10 |
6.6±1.7 |
6.3±0.8 |
4.2±0.5 |
1.2±0.5 |
1.0±0.7 |
Test 2 groups |
10 |
7.1±1.6 |
6.1±0.7 |
4.1±0.6 |
1.2±0.6 |
1.0±0.5 |
Test 3 groups |
10 |
3.4 ±1.5
* |
2.2±0.8
** |
1.2±0.6
** |
0.4±0.7
* |
0±0 |
Test 4 groups |
10 |
3.9±1.7
** |
2.4±0.7
** |
1.3±0.7
** |
0.4±0.6
* |
0±0 |
Test 5 groups |
10 |
7.0±1.8 |
6.3±0.6 |
4.4±0.8 |
1.1±0.7
* |
1.1±0.7 |
Annotate: with 1,2,5 group of comparison * * p<0.01, * P<0.05
Experimental result shows, 3 groups of medicinal plasters of the present invention and 4 groups are changed significantly to disappearing of the traumatic ecchymosis of rat, with all the other each groups P<0.05 relatively.This shows that medicinal plaster of the present invention has good therapeutical effect to the rat local wound in Radix Notoginseng 650-850g Radix Angelicae Dahuricae 165-185g Eupolyphaga Seu Steleophaga 165-185g Rhizoma Chuanxiong 165-185g Radix Angelicae Sinensis 165-185g Flos Carthami 165-185g Borneolum Syntheticum 30-40g Camphora 30-40g methyl salicylate 40-60g Mentholum 70-90g Semen daturae fluid extract 70-90g chondroitin sulfate 5-15g diphhydramine hydrochloride 10-15g dimethyl sulfoxide 70-90g scope.3 groups of the bests of its efficacy experiment are taken second place for testing 4 groups, and unsatisfactory curative effect goes beyond the scope.
Two, medicinal plaster of the present invention is to the influence of hemorheology of rat
Experimental technique and result
Get 50 of above-mentioned rats, the male and female dual-purpose is divided into 5 groups at random, 10 every group, uses 8%Na in preceding 24 hours in experiment
2S removes rat back Mus hair, 5 * 4cm
2Each group sticks administration.Medicinal plaster dosage of the present invention is the said medicine grouping.Once a day, continuous 10 days, last administration was plucked rat eye and is got blood after 1 hour, surveyed whole blood viscosity, whole blood reduced viscosity, erythrocyte electrophoretic time equal size.Carry out t then between the group and check, the results are shown in Table 3.
Table 3, SHENYANG HONGYAO plaster are to the influence of hemorheology of rat (X ± SD)
Group |
Number of animals only |
Whole blood viscosity (ratio) mpas
|
Whole blood reduced viscosity mps) |
Red thin breast electrophoresis time (s) |
Height is cut |
Low cutting |
Testing 1 group tests 2 groups and tests 3 groups and test 4 groups |
10 10 10 10 |
6.38±0.99 5.87±0.54 4.91±0.47
※※※ 5.17±0.74
※※ |
4.71±2.15 13.56±1.54 8.55±1.80
※※※8.66±1.64
※※※ |
9.10±0.47 8.32±1.06 7.38±1.21
※※7.31±1.26
※※ |
22.54±3.49 21.35±2.00 17.42±2.88
※※ 17.44±3.10
※※ |
Test 5 groups |
10 |
5.99±0.58 |
13.99±1.4 |
8.45 ±1.32 |
21.50±3.11 |
Annotate: with 1,2,5 group of comparison
※P<0.05,
※ ※P<0.01.
※※※P<0.001
Experimental result shows: 3 groups and 4 groups and outer relatively P<0.05 of respectively organizing of all the other scopes in the above-mentioned scope of medicinal plaster of the present invention, significant difference shows its effect of invigorating blood circulation.3 groups of the bests of its efficacy experiment are taken second place for testing 4 groups, and scope is respectively organized unsatisfactory curative effect outward.
Sum up:
In sum, our medicinal plaster of the present invention is as can be seen write out a prescription in above-mentioned scope rat local wound ecchymosis is had good therapeutical effect, with all the other respectively organize relatively (p<0.05) significant difference that is changed significantly that disappears of the traumatic ecchymosis of rat outside the scope.Medicinal plaster of the present invention is write out a prescription in above-mentioned scope all has remarkable change to the hemorheology index of rat, whole blood viscosity (ratio), whole blood reduced viscosity and erythrocyte electrophoretic time etc., shows the medicinal plaster of the present invention effect of invigorating blood circulation.Find out from above-mentioned two experimental results, test 3 groups of curative effect the bests, so prescription is decided to be: Radix Notoginseng 750g Radix Angelicae Dahuricae 175g Eupolyphaga Seu Steleophaga 175g Rhizoma Chuanxiong 175g Radix Angelicae Sinensis 175g Flos Carthami 175g Borneolum Syntheticum 35g Camphora 35g methyl salicylate 50g Mentholum 80g Semen daturae fluid extract 80g chondroitin sulfate 10g diphhydramine hydrochloride 12.5g dimethyl sulfoxide 80g.
Embodiment one
The primary raw material that medicine of the present invention is wherein made effective ingredient consists of by weight:
Radix Notoginseng: the Radix Angelicae Dahuricae: Eupolyphaga Seu Steleophaga: Rhizoma Chuanxiong: Radix Angelicae Sinensis: Flos Carthami: Borneolum Syntheticum: Camphora: methyl salicylate: Mentholum: Semen daturae fluid extract: chondroitin sulfate: diphhydramine hydrochloride: dimethyl sulfoxide=750: 175: 175: 175: 175: 175: 35: 35: 51: 80: 80: 10: 12: 80.
Its technology that is prepared into plaster is as follows:
(1) gets Radix Notoginseng 750g, Radix Angelicae Dahuricae 175g, Eupolyphaga Seu Steleophaga 175g, Rhizoma Chuanxiong 175g, Radix Angelicae Sinensis 175g, the fragmentation of Flos Carthami 175g Six-element medical material, with 90% alcohol reflux three times, add 4 times of amounts of ethanol for the first time, extracted 2 hours, second and third time adds 3 times of amounts of ethanol, extracted 1 hour, and left standstill, filter, merge supernatant, supernatant is pumped in the triple effect concentration tank vacuum decompression concentrate from hold-up tank, being concentrated into relative density is the clear paste of 1.24-1.26 (gravimeter is measured, and temperature is measured in the time of 50-60 ℃); Add 4 times of amount 90% ethanol then in clear paste, fully stirring and evenly mixing left standstill 24 hours, draw supernatant and filter, be concentrated into the thick paste 1.5kg that relative density is 1.35-1.37 (40-45 ℃ time mensuration), paste-forming rate 18.5% with the spherical tank vacuum decompression, receive cream, get extractum;
(2) preparation substrate: described substrate by the following raw materials in parts by weight number than forming:
Rubber: zinc oxide: lanoline: Colophonium: vaseline: liquid paraffin=48: 61-62: 5-6: 48-50: 8-9: 1-2;
The preparation method of substrate comprises following processing step:
It is that 50-60 ℃ constant temperature oven temperature, glue dries by the fire soft, standby more than 4 hours that rubber is placed temperature; With the roll extrusion 30 minutes repeatedly on glue pressing machine of the soft rubber of baking, refining is pressed into the thick plain film of 4mm, places standby more than 12 hours; Get plain film and put on the glue pressing machine roll extrusion after about 20 minutes, the flanging of zinc oxide limit is blended into, mixingly repeatedly all presses to the greatest extent to zinc oxide, beat the triangle bag to smooth surface, exquisiteness, even after, be pressed into thickness and take off to be put on the clean sun terrace less than the film of 4mm and cool, elastomeric compound; With microtome elastomeric compound is cut into small pieces, is stored in cleaning and moulds in the basket, standby; Lanoline packed in about 80 ℃, melt in the pot, and constantly stir, leave standstill after treating all to melt and be cooled to about 40 ℃, standby; To be 48 with the rubber weight ratio: the solvent 120# gasoline of 80-100 pumps in the agitator tank, the film that under stirring, adds cutting slowly, after stirring in 8 hours, carry out batch turning, continue after the batch turning to stir 2 hours, drop into Colophonium, stir after 2 hours, input vaseline, lanoline, liquid paraffin stirred 1 hour, and batch turning continues stirring and got substrate in 1 hour.
(3) get above-mentioned substrate, the consumption of substrate and the weight ratio of Radix Notoginseng are 48: 50, in substrate, add above-mentioned extractum and Borneolum Syntheticum, Camphora, methyl salicylate, Mentholum, Semen daturae fluid extract, chondroitin sulfate, diphhydramine hydrochloride, dimethyl sulfoxide, essence, carmine is an amount of, stirs, and makes coating, be coated with cream, the lid lining, section, packing, that is, wherein essence, carmine, with the weight ratio of Borneolum Syntheticum be 0.8: 0.332.33.
The specification of above-mentioned plaster dosage form is: 7 * 10cm
2
Embodiment two
The primary raw material that medicine of the present invention is wherein made effective ingredient connects weight ratio and consists of:
Radix Notoginseng: the Radix Angelicae Dahuricae: Eupolyphaga Seu Steleophaga: Rhizoma Chuanxiong: Radix Angelicae Sinensis: Flos Carthami: Borneolum Syntheticum: Camphora: methyl salicylate: Mentholum: Semen daturae fluid extract: chondroitin sulfate: diphhydramine hydrochloride: dimethyl sulfoxide=50: 11.7: 11.7: 11.7: 11.7: 11.7: 2.33: 2.33: 3.4: 5.33: 5.33: 0.67: 0.8: 5.33.
Its technology that is prepared into plaster is as follows:
Get Radix Notoginseng, the Radix Angelicae Dahuricae, Eupolyphaga Seu Steleophaga, Rhizoma Chuanxiong, Radix Angelicae Sinensis, the fragmentation of Flos Carthami Six-element medical material by above-mentioned weight ratio, with 85-95% alcohol reflux three times, for the first time add ethanol 3-5 and doubly measure, extracted 1.5-3 hour, second and third time adds ethanol 2-4 and doubly measures, extracted 0.5-1.5 hour, leave standstill, filter, merge supernatant, recovery ethanol concentrating under reduced pressure is made relative density and be the extractum that the 1.3-1.4 temperature is measured in the time of 38-45 ℃, and is standby;
Get substrate, the consumption of substrate and the weight ratio of Radix Notoginseng are Borneolum Syntheticum, Camphora, methyl salicylate, Mentholum, Semen daturae fluid extract, chondroitin sulfate diphhydramine hydrochloride, the dimethyl sulfoxide that in substrate adds above-mentioned extractum at 48: 52 and meet above-mentioned weight ratio, stir, make coating, be coated with cream, lid lining, section, packing promptly gets plaster.Substrate described in the present embodiment can adopt common as the employed common substrate of Chinese medicine plaster.
Embodiment three
The primary raw material that medicine of the present invention is wherein made effective ingredient consists of by weight:
Radix Notoginseng: the Radix Angelicae Dahuricae: Eupolyphaga Seu Steleophaga: Rhizoma Chuanxiong: Radix Angelicae Sinensis: Flos Carthami: Borneolum Syntheticum: Camphora: methyl salicylate: Mentholum: Semen daturae fluid extract: chondroitin sulfate: diphhydramine hydrochloride: dimethyl sulfoxide=850: 165: 165165: 165: 165: 30: 30: 40: 70: 70: 5: 10: 70.
Its technology that is prepared into plaster is as follows:
In order to improve the quality of products and production efficiency, alcohol extraction among the embodiment one chosen wash the back medical material and place the multipotency extraction pot to add 90% alcohol heating reflux to extract 2 times, add for the first time 6 times of amount 90% ethanol, reflux, extract, 2 hours, add for the second time 4 times of amount 90% ethanol, reflux, extract, 1 hour merges medicinal liquid, store in the hold-up tank, other step is with embodiment one.
Embodiment four
The primary raw material that medicine of the present invention is wherein made effective ingredient consists of by weight:
Radix Notoginseng: the Radix Angelicae Dahuricae: Eupolyphaga Seu Steleophaga: Rhizoma Chuanxiong: Radix Angelicae Sinensis: Flos Carthami: Borneolum Syntheticum: Camphora: methyl salicylate: Mentholum: Semen daturae fluid extract: chondroitin sulfate: diphhydramine hydrochloride: dimethyl sulfoxide=650: 185: 185185: 185: 185: 40: 40: 60: 90: 90: 15: 15: 90.
With its technology that is prepared into plaster with embodiment two.
Embodiment five
The primary raw material that medicine of the present invention is wherein made effective ingredient consists of by weight:
Radix Notoginseng: the Radix Angelicae Dahuricae: Eupolyphaga Seu Steleophaga: Rhizoma Chuanxiong: Radix Angelicae Sinensis: Flos Carthami: Borneolum Syntheticum: Camphora: methyl salicylate: Mentholum: Semen daturae fluid extract: chondroitin sulfate: diphhydramine hydrochloride: dimethyl sulfoxide=650: 165: 165: 185: 185: 185: 40: 40: 40: 70: 90: 5: 10: 90.
With its technology that is prepared into plaster with embodiment two.
Embodiment six
The primary raw material that medicine of the present invention is wherein made effective ingredient consists of by weight:
Radix Notoginseng: the Radix Angelicae Dahuricae: Eupolyphaga Seu Steleophaga: Rhizoma Chuanxiong: Radix Angelicae Sinensis: Flos Carthami: Borneolum Syntheticum: Camphora: methyl salicylate: Mentholum: Semen daturae fluid extract: chondroitin sulfate: diphhydramine hydrochloride: dimethyl sulfoxide=850: 185: 185: 165: 165: 165: 30: 30: 60: 90: 70: 15: 15: 70.
With its technology that is prepared into plaster with embodiment one.
Embodiment seven
The primary raw material that medicine of the present invention is wherein made effective ingredient consists of by weight:
Radix Notoginseng: the Radix Angelicae Dahuricae: Eupolyphaga Seu Steleophaga: Rhizoma Chuanxiong: Radix Angelicae Sinensis: Flos Carthami: Borneolum Syntheticum: Camphora: methyl salicylate: Mentholum: Semen daturae fluid extract: chondroitin sulfate: diphhydramine hydrochloride: dimethyl sulfoxide=700: 170: 170170: 170: 170: 33: 33: 45: 75: 75: 8: 12: 75.
With its technology that is prepared into plaster with embodiment one.
Embodiment eight
The primary raw material that medicine of the present invention is wherein made effective ingredient consists of by weight:
Radix Notoginseng: the Radix Angelicae Dahuricae: Eupolyphaga Seu Steleophaga: Rhizoma Chuanxiong: Radix Angelicae Sinensis: Flos Carthami: Borneolum Syntheticum: Camphora: methyl salicylate: Mentholum: Semen daturae fluid extract: chondroitin sulfate: diphhydramine hydrochloride: dimethyl sulfoxide=800: 180: 180: 180: 180: 180: 38: 38: 55: 85: 85: 12: 13: 85.
With its technology that is prepared into plaster with embodiment three.
Embodiment nine
The primary raw material that medicine of the present invention is wherein made effective ingredient consists of by weight:
Radix Notoginseng: the Radix Angelicae Dahuricae: Eupolyphaga Seu Steleophaga: Rhizoma Chuanxiong: Radix Angelicae Sinensis: Flos Carthami: Borneolum Syntheticum: Camphora: methyl salicylate: Mentholum: Semen daturae fluid extract: chondroitin sulfate: diphhydramine hydrochloride: dimethyl sulfoxide=700: 180: 180: 170: 170: 180: 38: 38: 55: 85: 85: 12: 13: 85.
With its technology that is prepared into plaster with embodiment two.
Embodiment ten
The primary raw material that medicine of the present invention is wherein made effective ingredient consists of by weight:
Radix Notoginseng: the Radix Angelicae Dahuricae: Eupolyphaga Seu Steleophaga: Rhizoma Chuanxiong: Radix Angelicae Sinensis: Flos Carthami: Borneolum Syntheticum: Camphora: methyl salicylate: Mentholum: Semen daturae fluid extract: chondroitin sulfate: diphhydramine hydrochloride: dimethyl sulfoxide=735: 176: 178: 173: 172: 175: 34: 37: 48: 80: 82: 9: 11: 78.
With its technology that is prepared into plaster with embodiment two.