CN1259949C - Capsule for treating wound - Google Patents
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- CN1259949C CN1259949C CN 03151123 CN03151123A CN1259949C CN 1259949 C CN1259949 C CN 1259949C CN 03151123 CN03151123 CN 03151123 CN 03151123 A CN03151123 A CN 03151123A CN 1259949 C CN1259949 C CN 1259949C
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Abstract
The present invention relates to a medical product, particularly to a traditional Chinese medicine prepared capsule for treating wounds, which is used for treating acute soft tissue contused wounds, fractured pain and the injuries of the muscles and tendons. The traditional Chinese medicine prepared capsule for treating wounds uses notoginseng, dragon blood, red sage root, asarum herb, prepared nutagrass flatsedge rhizome, corydalis tuber, poria coco, orange peel and angelica dahurica as raw materials. The raw materials are prepared into the capsule by a normal method, and the traditional Chinese medicine prepared capsule for treating wounds has significant effect on treating symptoms, such as the pain of soft tissue injuries, the tumefaction of the soft tissue injuries, functional disorder, muscle spasm, etc., and can promote functional recovery. Simultaneously, the present invention has the advantages of no toxic and side effect, simple and convenient manufacture and use, and easily acceptance by patients.
Description
Technical field
The present invention relates to a kind of pharmaceuticals, specifically is a kind of capsule (hereinafter to be referred as Capsule for treating wound) of the treatment pain of injury of Chinese medicine preparation, is used for the treatment of the pain and the muscle and tendon injury of acute soft tissue contusion, fracture.
Background technology
Chinese patent literature CN1092066C discloses a kind of " analgesic plaster for osteoarthritis ", and it is a raw material with 44 kinds of Chinese medicines such as Radix Notoginseng, Radix Salviae Miltiorrhizae, Sanguis Draxonis, Herba Asaris, boils by a certain percentage, and the pain that osteoarthritis is caused has better curative effect.But following deficiency is arranged, the one, raw material is crossed nearly 44 kinds, wherein is no lack of rare medicinal herbs, and preparation is complicated, has improved cost; The 2nd, ZHITONG GAO is external, and absorbent properties are poor.
Summary of the invention
The technical issues that need to address of the present invention are at above-mentioned situation, overcome the existing deficiency of prior art, provide a kind of evident in efficacy, and preparation is simple, the Capsule for treating wound of the grieved damage of lower-cost treatment.
Solution of the present invention is according to the understanding of the traditional Chinese medical science to acute soft tissue contusion, fracture, according to traditional Chinese medical science prescription and the capsule that processes of preparation principle.
The present invention is prepared according to a conventional method by Chinese medicine, it is characterized in that containing in per 1000 capsules the Chinese medicine of following weight:
Radix Notoginseng 200～300g, Sanguis Draxonis 40～80g, Radix Salviae Miltiorrhizae 200～400g, Herba Asari 20～40g, Rhizoma Cyperi (processed) 200～400g, Rhizoma Corydalis 300～500g.
Optimum ratio of the present invention is:
Radix Notoginseng 220～280g, Sanguis Draxonis 50～70g, Radix Salviae Miltiorrhizae 250～350g, Herba Asari 25～35g, Rhizoma Cyperi (processed) 250～350g, Rhizoma Corydalis 350～450g, Poria 250～350g, Pericarpium Citri Reticulatae 250～350g, the Radix Angelicae Dahuricae 160～200g.
Optimal proportion of the present invention is:
Radix Notoginseng 250g, Sanguis Draxonis 60g, Radix Salviae Miltiorrhizae 300g, Herba Asari 30g, Rhizoma Cyperi (processed) 300g, Rhizoma Corydalis 400g, Poria 300g, Pericarpium Citri Reticulatae 300g, Radix Angelicae Dahuricae 180g.
Compare with existing grieved ointment in the present invention's prescription, newly added Chinese medicines such as Rhizoma Corydalis, Rhizoma Cyperi, Poria, Pericarpium Citri Reticulatae.But the pain relieving of Rhizoma Corydalis blood-activating and qi-promoting, blood stasis dispersing and pain alleviating, blood vessel dilating; Rhizoma Cyperi is a QI regulating medicine, and property is flat, but antipyretic-antalgic, antimicrobial antiphlogistic; Poria promoting diuresis to eliminate damp pathogen, spleen invigorating invigorating middle warmer have diuresis, promote the function of hemopoietic; The Radix Angelicae Dahuricae, the wind that can loose dehumidifying reducing swelling and alleviating pain; Pericarpium Citri Reticulatae has the antiinflammatory antiallergic, the function of enhance immunity.Chinese medicines such as they and Radix Notoginseng, Sanguis Draxonis, Radix Salviae Miltiorrhizae, Herba Asari are formulated together, make the present invention more remarkable to the curative effect of analgesia, repercussive.
The specific embodiment
Below by embodiment, technical scheme of the present invention is described in further detail.
Most preferred embodiment of the present invention: prepare according to a conventional method by Chinese medicine, contain the Chinese medicine of following weight in per 1000 capsules:
Radix Notoginseng 250g, Sanguis Draxonis 60g, Radix Salviae Miltiorrhizae 300g, Herba Asari 30g, Rhizoma Cyperi (processed) 300g, Rhizoma Corydalis 400g, Poria 300g, Pericarpium Citri Reticulatae 300g, Radix Angelicae Dahuricae 180g.
The present invention can prove that by pharmacodynamics test and clinical trial it has the pain and the muscle and tendon injury of treatment acute soft tissue contusion, fracture.
1. pharmacodynamics test
1.1 experiment material
Tried thing:
We have carried out the animal experiment of pharmacodynamics to Capsule for treating wound, method is as follows: Capsule for treating wound and HUOXUE ZHIRONG JIAONANG 0.25g/ grain (lot number 000604, Nanjing Zhongshan Pharmaceutical Factory) compares group, from Capsule for treating wound to microcirculatory influence, dissipating blood stasis effect to hematoma, test the pharmacodynamics of Capsule for treating wound aspects such as analgesic effect.
Animal ICR mice, SD rat provide [No. (96) 007, the real moving accurate word in Zhejiang] by the Inst. of Traditional Chinese Medicine, Zhejiang Prov Animal House
1.2 experimental technique and result
1.2.1. microcirculation of mouse auricle is influenced
Mice is divided into the blank group at random, positive controls, and the large, medium and small dosage group of Capsule for treating wound, and every group of 10-12 is only.Capsule for treating wound respectively by 6,3,1.5g.kg
-1, positive control is with 3g.kg
-1Irritate HUOXUE ZHIRONG JIAONANG, the blank group is irritated the drinking water of stomach equivalent, behind the single gastric infusion 30min, with 0.4% pentobarbital sodium 0.3ml/10g intraperitoneal injection of anesthesia, the formula of bowing is fixed in observation platform, and three grades of branch vessel small artery (A), venule (V) caliber, netted capillary vessel number and the blood flow rate of 40min Mice Auricle are measured caliber with micro-micrometer after the record administration.Blood flow rate is divided linear flow, line grain stream, grain linear flow, grain stream, grain unhurried current, grain pendulum, seven grades that remain in a standstill by field Niu Shi semiquantitative method, and flow velocity is handled by grade preface value method (Ridit method).Result such as table 1, table 2.
Table 1 Capsule for treating wound is to Mice Auricle small artery (A) venule caliber (V)
And the influence of blood capillary opening amount (X ± S)
| Group | Dosage (g/kg) | Number of animals (only) | A caliber (um) | V caliber (um) | Capillary vessel number (bar) |
| Blank | - | 10 | 16.25±4.71 | 38.13±7.48 | 3.29±0.51 |
| Promoting blood circulation and stopping pain | 3 | 10 | 23.75±5.53** | 38.75±4.93 | 4.91±0.44 ** |
| Capsule for treating wound | 1.5 | 10 | 21.25±4.45 * | 38.13±5.47 | 4.18±0.62 ** |
| 3 | 10 | 21.2±53.23 * | 40.0±5.27 | 4.70±0.28 ** | |
| 6 | 10 | 21.63±3.59 ** | 41.85±5.95 | 5.04±0.47 ** |
Compare with the blank group
*P＜0.05
*P＜0.01
Table 2 Capsule for treating wound is to the influence of Mice Auricle capillary blood flow fluidised form
| Group | Dosage (g/kg) | Number of animals (only) | The flow velocity grade | ||
| Linear flow (+) | Line grain stream (++) | The grain linear flow (+++) | |||
| Blank | - | 11 | 2 | 5 | 4 |
| Promoting blood circulation and stopping pain | 3 | 12 | 11 | 0 | 1 |
| Capsule for treating wound | 1.5 | 10 | 8 | 1 | 1 |
| 3 | 11 | 7 | 4 | 0 | |
| 6 | 12 | 11 | 1 | 0 | |
Compare P＜0.01 with the blank group
The result shows: Capsule for treating wound can significantly increase the open number of Mice Auricle arteriole caliber and blood capillary, with in, heavy dose is particularly remarkable.Compare with the blank group, each administration group is all significantly improved blood flow rate, promotes circulation.
1.2.2. dissipating blood stasis effect to rat self hematoma
Get 50 of SD rats, body weight 150-170g is male, and behind every Mus etherization, heart extracting blood 0.15ml injects left footpad portion blood stasis, and modeling is measured sufficient sole of the foot girth and is divided into 5 groups according to the swelling degree after 1 hour; Be blank group, HUOXUE ZHIRONG JIAONANG group, large, medium and small three the dosage groups of Capsule for treating wound.The blank group is irritated stomach drinking water 1.5ml/100g body weight.Behind the single gastric infusion 2 hours, the difference of sufficient sole of the foot girth is an index about measuring, and compares with the blank group, the results are shown in Table 3.
Table 3 Capsule for treating wound is to the influence of rat self hematoma (X ± S)
| Group | Dosage g/kg | The animal number of elements | Before the modeling (cm) | 1 hour swelling value (cm) of modeling | Modeling 1 little time difference value | Two sufficient sole of the foot girth differences (cm) | 2 little time difference value behind the medicine |
| Blank | - | 10 | 2.22±0.04 | 2.63±0.13 | 0.41±0.12 | 2.67±0.10 | 0.45±0.10 |
| Promoting blood circulation and stopping pain | 3 | 10 | 2.22±0.04 | 2.65±0.13 | 0.43±0.12 | 2.55±0.10 | 0.34±0.08 * |
| Capsule for treating wound | 1.5 | 10 | 2.24±0.05 | 2.65±0.14 | 0.41±0.11 | 2.57±0.08 | 0.31±0.10 ** |
| 3 | 10 | 2.22±0.04 | 2.64±0.13 | 0.42±0.11 | 2.57±0.09 | 0.35±0.08 * | |
| 6 | 10 | 2.25±0.05 | 2.68±0.13 | 0.43±0.13 | 0.61±0.06 | 0.36±0.08 * |
Compare with matched group
*P＜0.05,
*P＜0.01
The result shows that hindering preceding each dosage group of capsule all has remarkable elimination self blood stasis effect.
1.2.3. influence to ear swelling due to the mice dimethylbenzene:
50 body weight 20-22g of ICR mice, be divided into 5 groups at random, every group 10, male and female half and half, promptly be divided into the blank group, positive controls and Capsule for treating wound are big, in, little three dosage groups, blank group is only irritated stomach ordinary water 0.6ml/, positive group and grieved group are only irritated stomach variable concentrations suspension 0.6ml/, single gastric infusion 1h drips dimethylbenzene 0.05ml in mouse right ear and puts to death animal after 20 minutes, gets auricle with the 9mm card punch along the punching of left and right sides auricle same area, weigh respectively with two auricle differences as the swelling level index, relatively the difference results between administration group and matched group group sees Table 4.
The bullate influence of table 4 Capsule for treating wound xylol induced mice ear (X ± S, mg)
| Group | Dosage (g/kg) | Number of animals (only) | Heavy sheet/the mg of left side auricle | Heavy sheet/the mg of auris dextra sheet | Two auricle weight differences |
| Blank | - | 10 | 30.98±6.73 | 11.50±0.77 | 19.48±6.26 |
| Promoting blood circulation and stopping pain | 3 | 10 | 23.27±4.56 | 11.46±1.07 | 12.69±5.66 * |
| Capsule for treating wound | 1.5 | 10 | 22.98±0.61 | 11.58±0.95 | 11.40±4.56 * |
| 3 | 10 | 22.91±7.10 | 11.71±0.91 | 11.20±6.71 * | |
| 6 | 10 | 28.69±4.13 | 12.00±0.43 | 17.69±4.69 |
Compare with the blank group
*P＜0.05
The result shows that the ear swelling due to the big or middle dosage xylol of Capsule for treating wound all has remarkable inhibitory action.
1.2.4. to turning round the influence of body number due to the mice acetic acid
50 of laboratory mices, body weight 18-20g is divided into 5 groups at random, and 10 every group, male and female half and half.Be that blank is formed, large, medium and small three the dosage groups of Capsule for treating wound, positive controls, 1h behind every mice single gastric infusion 0.6ml medicine, every mouse peritoneal is injected 0.7% glacial acetic acid 0.1ml/10g body weight, record is turned round the body number in the 20min, the results are shown in Table 4.
The influence of table 5 Capsule for treating wound Dichlorodiphenyl Acetate induced mice writhing response
| Group | Dosage (g/kg) | Number of animals (only) | Turn round body number (X ± S, inferior) |
| Blank | - | 10 | 56.5±19.01 |
| Promoting blood circulation and stopping pain | 3 | 10 | 38.3±17.44 * |
| Capsule for treating wound | 1.5 | 10 | 38.5±13.39 * |
| 3 | 10 | 39.3±18.90 * | |
| 6 | 10 | 46.3±18.97 |
Compare with the blank group
*P＜0.05
The result shows: the big-and-middle dosage group of Capsule for treating wound all has significant analgesic activity.
1.3 conclusion
Above-mentioned result of study shows that Capsule for treating wound has significant blood vessel dilating and increases the reparation that blood flow rate helps the elimination of blood stasis and damages the back microcirculation disturbance, experimental result has also proved the detumescence and the analgesic activity of Capsule for treating wound, for the clinical practice of Capsule for treating wound provides the drug effect foundation.
2. clinical trial
2.1 clinical data
2.1.1 physical data
This group is totally 495 examples, and 345 examples are organized in treatment, positive control A group HUOXUE ZHIRONG JIAONANG 50 examples, B group indometacin enteric coatel tablets 50 examples, blank group 50 examples; Sex: male 267 examples, women 228 examples, M-F 1.17: 1; Four groups relatively, X
2=0.1533, P＞0.05.Age: maximum 60 years old, minimum 20 years old, 33.8 years old mean age; Wherein, less than 30 years old 232 example, 31～45 years old 183 example, 46～60 years old 80 example; Compare U=0.3115 for four groups; P＞0.05.The course of disease: hinder back 1 day 287 example, 2 days 124 examples, 3 days 84 examples, average 1.6 days, four groups were compared X
2=1.6928, P＞0.05.Position: upper limb 158 examples, lower limb 337 examples; The state of an illness: slight 89 examples, moderate 198 examples, severe 208 examples, four groups are relatively, U=0; P＞0.05.
2.1.2 diagnostic criteria
With the diagnostic criteria as research such as scorching hot of extremity corresponding site pain, swelling, tenderness, muscle spasm, dysfunction and skin after the wound.
2.1.3 exclusion standard
(1) under-18s, more than 60 years old, gestation or women breast-feeding their children.(2) suffer from disease patients such as the heart, liver, kidney and disease of hematopoietic system, psychosis, tuberculosis, tumor.(3) fracture and other visceral organ injuries, cerebral trauma person.(4) to this drug allergy person.
2.1.4 rejecting standard
(1) not medication in accordance with regulations can't judge that curative effect or data are incomplete, affects the treatment and safety judgement person.
(2) use in conjunction other drug or physical therapy person.
2.2 Therapeutic Method
2.2.1 grouping
(1) treatment group
Medicament sources: orthopedics department hospital preparation chamber, Wenling
Specification: 0.5g/ grain
Medication: oral meal, every day 3 times, each 1.0g
(2) matched group
A organizes HUOXUE ZHIRONG JIAONANG, and Department of Pharmacy's Nanjing Zhongshan Pharmaceutical Factory is produced;
Specification: 0.25g/ grain;
Medication: oral meal, every day 3 times, each 0.75g.
B organizes indometacin, Jiangsu Taicang Pharmaceutical Factory;
Specification: 25mg/ grain;
Medication: oral meal, every day 3 times, each 25mg.
The blank group
Oral galactenzyme raw cook, every day 3 times, each 3.
2.2.2 observation index
(1) degree of injury pain, tenderness and swelling, the scope of function limitation, the situation that muscle spasm and skin are scorching hot.(2) blood, urine, stool routine examination, hepatic and renal function and Electrocardioscopy.(3) skin allergy and the intestines and stomach reaction.(4) spirit and neural situation of change.
2.2.3 severity extent assessment
(1) pain: be difficult to stand 3 fens, can stand 2 fens, hypodynia 1 minute.(2) swelling: compare＞1cm3 branch with the Zhou Jing of strong side same area;＜1cm,＞the 0.5cm2 branch;＜0.5cm1 branch.(3) tenderness: light pressed promptly pain or tenderness 3 minutes; Tenderness did not have tenderness 2 minutes; Tenderness need be exerted oneself 1 fen.(4) muscle spasm: as tabular, elasticity disappeared 3 fens; Poor flexibility 2 minutes; Spasm slightly, elasticity can 1 minute.(5) dysfunction: joint motion reduces above 3 minutes of 30 degree; 30～20 degree 2 minutes; Following 1 minute of 20 degree.(6) skin is scorching hot: obviously scorching hot 3 minutes; Scorching hot 2 minutes of moderate; Slight scorching hot 1 minute.Severity extent is according to Lou Shi calibration standard, be divided into light, in, weigh three degree: 1～6 be divided into slight; 7～12 are divided into moderate; 13～18 are divided into severe.
2.2.4 curative effect determinate standard
2.2.4.1 criterion of therapeutical effect
Criterion of therapeutical effect in " the new Chinese medicine clinical research guideline " issued with reference to Ministry of Public Health is judged.Clinical cure: the sings and symptoms complete obiteration, the treatment back is not more than 1 fen overall the branch; Produce effects: sings and symptoms improves, and the overall branch in treatment back reduces more than 1/3; Invalid: sings and symptoms does not have obvious improvement, and treatment back total mark reduces less than 1/3.Criterion of therapeutical effect: cure: swell and ache and disappear, functional rehabilitation is normal; Produce effects: symptom disappears substantially, but residual slightly swelling and ache and dysfunction; Effectively: symptom is obviously improved, but the injury still has and swells and ache function limitation; Invalid: symptom does not have obvious improvement.
2.2.4.2 test method
In hospital, be responsible for, allly adopt single blind randomized to be divided into treatment group and matched group through the person of making a definite diagnosis by designated doctor.Two groups are all adopted oral specified dose, and 7 days is 1 course of treatment, observe case all to exceed two courses of treatment.
2.2.4.3 point of observation
3 days, 5 days, 7 days, 9 days, 11 days, 14 days
2.2.4.4 observation item
All selected objects are registered by observation item by the doctor and are followed up a case by regular visits to and resident's pathography, and Follow-up results is carried out statistical disposition.
2.3 therapeutic outcome
2.3.1 total effects
Therapeutic outcome shows: the cure rate of treatment group is 48%, effective percentage 84.1%;
Table 1: two groups of total effectses relatively
| Group | The example number | Recovery from illness | Produce effects | Effectively | Invalid | Effective percentage | |
| The treatment group | 345 | 91 | 80 | 122 | 52 | 84.1％ | |
| Matched group | The A group | 50 50 50 | 13 8 1 | 14 12 2 | 14 17 10 | 9 13 37 | 82％ 74％ 26％ |
| The B group | |||||||
| The blank group | |||||||
Treatment group and matched group are relatively analyzed through Ridit, and the result shows: compare U=0.2158P＞0.05 with the A group; Compare U=1.6185 P＜0.05 with the B group; Relatively significant difference is arranged U=4.6128P＜0.001 with the blank group.
Table 2: individual event symptom curative effect
| Project | Group | Before the treatment | After the treatment | |
| Pain | The treatment group | 2.50±0.54* | 0.52±0.65** | |
| Matched group | The A group | 2.43±0.5 | 0.68±0.73 | |
| The B group | 2.48±0.43 | 0.63±0.5 | ||
| Blank group | 2.51±0.38 | 1.83±0.68 | ||
| Swelling | The treatment group | 2.14±0.83* | 0.28±0.54*** | |
| Matched group | The A group | 2.04±0.78 | 0.62±0.70 | |
| The B group | 1.98±0.75 | 1.25±0.60 | ||
| Blank group | 2.11±0.71 | 1.50±0.68 | ||
| Tenderness | The treatment group | 2.44±0.58 | 0.40±0.46** | |
| Matched group | The A group | 2.48±0.54 | 0.75±0.62 | |
| The B group | 2.54±0.44 | 0.60±0.56 | ||
| Blank group | 2.40±0.48 | 1.60±0.61 | ||
| Muscle spasm | The treatment group | 1.80±0.9 | 0.11±0.25** | |
| Matched group | The A group | 1.75±0.68 | 0.65±0.33 | |
| The B group | 1.26±0.88 | 0.56±0.73 | ||
| Blank group | 1.58±0.53 | 1.12±0.64 | ||
| Dysfunction | The treatment group | 1.60±0.79 | 0.15±0.54** | |
| Matched group | The A group | 1.48±0.93 | 0.81±0.49 | |
| The B group | 1.56±0.85 | 0.52±0.61 | ||
| Blank group | 1.40±0.78 | 0.98±0.67 | ||
| Skin is scorching hot | The treatment group | 1.55±0.62 | 0.38±0.34* | |
| Matched group | The A group | 1.66±0.94 | 0.56±0.61 | |
| The B group | 1.54±0.71 | 0.53±0.42 | ||
| Blank group | 1.60±0.81 | 1.18±0.65 | ||
Show from individual event curative effect comparative result, the treatment group has significant curative effect in diseases such as pain, swelling, tenderness, muscle spasm, dysfunction and skin are scorching hot aspect improving, obviously being better than matched group (P＜0.01) aspect detumescent, alleviation, the muscle spasm, see the above table especially.
Table 3: severity extent and curative effect
| Degree | Group | Clinical cure | Produce effects | Effectively | Invalid | Add up to | Effective percentage | |
| Slightly | The treatment group | 40 | 12 | 2 | 0 | 54 | 100％ | |
| Matched group | The A group | 9 | 1 | 2 | 0 | 12 | 100％ | |
| The B group | 6 | 5 | 1 | 1 | 13 | 92％ | ||
| Blank group | 1 | 2 | 6 | 1 | 10 | 92％ | ||
| Moderate | The treatment group | 29 | 41 | 60 | 11 | 141 | 92％ | |
| Matched group | The A group | 2 | 12 | 2 | 1 | 17 | 94％ | |
| The B group | 2 | 5 | 1 | 2 | 10 | 80％ | ||
| Blank group | 0 | 0 | 5 | 15 | 20 | 25％ | ||
| Severe | The treatment group | 22 | 27 | 60 | 41 | 150 | 72.7％ | |
| Matched group | The A group | 2 | 1 | 10 | 8 | 21 | 62％ | |
| The B group | 0 | 2 | 15 | 10 | 27 | 62％ | ||
| Blank group | 0 | 0 | 0 | 20 | 20 | 0 | ||
As can be known from the above table, the effective percentage of variant severity extent group has notable difference (P＜0.05) in the treatment group; The treatment group and between the matched group at slight group no significant difference, in moderate and severe group notable difference is arranged, P respectively＜0.05,＜0.01, sees the above table
Age and therapeutic effect relationship
| Age (year) | Group | Clinical cure | Produce effects | Effectively | Invalid | Add up to | Effective percentage | |
| 18-30 | The treatment group | 63 | 58 | 26 | 25 | 172 | 85％ | |
| Matched group | The A group | 10 | 7 | 6 | 5 | 28 | 82％ | |
| The B group | 6 | 3 | 6 | 5 | 20 | 75％ | ||
| Blank group | 1 | 1 | 1 | 9 | 12 | 25％ | ||
| 31-45 | The treatment group | 25 | 12 | 76 | 20 | 133 | 84％ | |
| Matched group | The A group | 3 | 5 | 5 | 3 | 16 | 81％ | |
| The B group | 2 | 6 | 1 | 4 | 13 | 69％ | ||
| Blank group | 0 | 1 | 5 | 15 | 21 | 28％ | ||
| 46-60 | The treatment group | 3 | 10 | 20 | 7 | 40 | 82％ | |
| Matched group | The A group | 0 | 2 | 3 | 1 | 6 | 83％ | |
| The B group | 0 | 3 | 10 | 4 | 17 | 76％ | ||
| Blank group | 0 | 0 | 4 | 13 | 17 | 23％ | ||
Age and curative effect compare between two groups, and each age group effective percentage no significant difference (P＞0.05) is organized in treatment; Treatment group each age group all is better than matched group (P＜0.05), sees the above table.
2.3.2 safety is observed:
In the clinical research process, 345 routine medications front and back are organized in treatment all done detections such as routine blood test, defecation routine, hepatic and renal function and electrocardiogram, all in normal range, all cases do not have skin allergy to the result in therapeutic process.Illustrate that Capsule for treating wound does not have overt toxicity reaction and side effect, safe and reliable, can life-time service.
Table 4: untoward reaction after the medication
| The untoward reaction title | The example number | Adverse reaction rate |
| Nausea and vomiting | 2 | 0.5％ |
| Dizzy | 1 | 0.3％ |
Total untoward reaction rate: 0.8%.
2.4 discuss
In the damage disease, the normal while of qi depression to blood stasis also sees." element asks YIN YANG classification of natural phenomena big opinion " said: " impairment of QI resulting in pain, injury of configuration resulting in swelling.The person so bitterly then swell earlier, impairment of QI resulting in injury of the configuration is also; Swell and pain person earlier, injury of configuration resulting in impairment of QI also." Li Zhongzi's note is that " a surname is logical in the gas happiness, and impairment of QI is then stopped up and closed and obstructed, so bitterly; Shape is that matter resembles, and the shape wound is then delaied and do not changed, so swollen." injury of configuration resulting in swelling in traumatology is that blood stasis causes swelling.The note that horse is transplanted is said: " so it is pain for swollen, and therefore machine is arranged mutually again, and the pain person that then do not swell is arranged earlier; Gai Yiqi is injured earlier and shape is also injured; the impairment of QI resulting in injury of the configuration of meaning also having the swollen pain person that then is earlier, and lid is injured with shape elder generation; and gas is also injured; the injury of configuration resulting in impairment of QI of meaning also, the non-gas of shape does not fill, the non-shape of gas is living; the shape gas phase is for depending on, and the phase factor person of disease and for example this." illustrate and the person of feeling frustrated whenever have blood stasis concurrently more, and blood is hindered the stasis of blood and is coagulated, and must cause and hinder the mechanism of qi circulation." miscellaneous diseases source and course rhinoceros candle tumbling down sprain and contusion source and course " said: " the tumbling down sprain and contusion, the soldier so is subjected to body, and in outer reaching, QI and blood is all also sick and wounded.”
In the Capsule for treating wound, Sanguis Draxonis, sweet-salty, property are flat, blood circulation promoting and blood stasis dispelling, hemostasis, are the panacea of traumatic injury; With sweet and slightly bitter taste Radix Notoginseng warm in nature, going into the kind hemostasis of blood system, merit again can blood stasis dispelling, tissue regeneration promoting, analgesic therapy; Radix Salviae Miltiorrhizae bitter in the mouth and cold nature, " nourshing blood and promoting blood circulation, tissue regeneration promoting blood, row stagnated blood " three is all monarch drug.The operation of blood depends on the promotion of gas, and gas has one expiration and inspiration not transport, and then blood has one expiration and inspiration not all right, thus be equipped with acrid in the mouth hardship, Rhizoma Corydalis blood-activating and qi-promoting pain relieving warm in nature in the side, " stagnation of QI in can promoting the circulation of blood, stasis in the gas, thus specially control all over the body all pains up and down, among using, simply fantastic "; Little sweet, the property of the little hardship of Rhizoma Cyperi acrid in the mouth is flat, function promoting QI circulation for relieving depression, alleviating pain and detumescence, and the hot row of this product fragrance is mainly gone into the Liver Channel edema caused by disorder of QI, is all ministerial drug.We join Herba Asari, get the chief of its blood stasis dispelling eliminating stagnation, expelling wind and cold, pain relieving, and few cloudy kidney channel of both loosing, is searched the rheumatism between the muscles and bones again and exempted from the numbness pain relieving with activating YANG and eliminating stagnation the cold-evil of lining; The acrid in the mouth Radix Angelicae Dahuricae warm in nature in addition, loose wind dehumidifying, reducing swelling and alleviating pain, both are combined into adjuvant drug.Make with Pericarpium Citri Reticulatae promoting the circulation of QI to relieve pain, spleen invigorating and in; Poria promoting diuresis to eliminate damp pathogen, spleen invigorating invigorating middle warmer.The all medicines of this side share, and not only promoting the circulation of blood divides the stasis of blood to stagnate, and pent-up that again can the circulation of qi promoting branch is invigorated blood circulation and hematozemia not, and blood stasis dispelling again can tissue regeneration promoting, the stasis of blood row that degass, and all cards can be healed.
Pharmaceutical research according to the modern times shows: Sanguis Draxonis water decoction-alcohol sedimentation liquid can obviously be accelerated erythrocyte and hematoblastic electrophoretic velocity, and anticoagulant increases fibrinolytic activity, and antithrombotic forms.Radix Notoginseng shortens clotting time, and very strong anastalsis is arranged, and Radix Notoginseng extract can also resist rabbit platelet aggregation due to the ADP simultaneously, and whole blood viscosity is descended, and Radix Notoginseng total arasaponins has obvious anti-inflammatory analgesic.Radix Salviae Miltiorrhizae can improve fibrinolytic and enzymatic activity, promotes fibrinolysis, microcirculation improvement, and can regulate reparation and the regenerated effect of organizing, and three kinds of drug synergisms can be stopped blooding and can dissipating blood stasis for subsidence of swelling, have dual regulation.Rhizoma Corydalis contains 20 kinds of alkaloids, has stronger analgesic effect.Poria extract can promote sodium ion to discharge, and has the inducing diuresis to remove edema effect.Angelicotoxin in the Radix Angelicae Dahuricae, Herba Asari volatile oil, Rhizoma Cyperi volatile oil all can improve the threshold of pain, and calmness, analgesia, analgesic, antiinflammatory action are arranged.The experimentation of the pharmacodynamics of this experiment has also confirmed this prescription at microcirculation improvement, and there is good effect aspects such as microvascular expansion, the absorption that promotes hematoma, anti-inflammatory and antalgic.
This research is to 495 routine soft tissue injury patients, according to its state of an illness light, in, heavily reach the age stratification pairing, single at random blind contrast, carry out clinical observation, the result shows: Capsule for treating wound improves significantly for symptoms such as the pain of acute soft tissue injury, swelling, dysfunction, muscle spasm, compare with matched group, P＜0.01, its Repercusion analgesia effect obviously is better than matched group, the effect of detumescent, relieve muscle spasms that Capsule for treating wound is described is obvious, can ease pain, can promote functional rehabilitation again.Simultaneously, we have made routine blood test, hepatic and renal function, electrocardiogram etc. to the treatment group and have followed the tracks of detection, and are all normal before and after the result, illustrate that Capsule for treating wound does not have obvious toxic and side effects, can take for a long time.
2.5 conclusion
By above-mentioned experimentation and clinical observation, proved that Capsule for treating wound has tangible antiinflammatory, detumescence, pain relieving to soft tissue injury, effective percentage 84.1%, and few side effects provide a kind of good medicine for orthopedics department is clinical.The effect of Capsule for treating wound others is also treated to excavate in further research.
The present invention is used for the pain and the muscle and tendon injury of acute soft tissue contusion, the pain of fracture, and oral meal, a 2-4 grain, 3 times on the one, the child is cut down according to the circumstance.
After the present invention carries out animal experiment and clinical observation, show that it is a kind of evident in efficacy, preparation is simple, and cost is lower, the Capsule for treating wound of the grieved damage of the treatment that has no side effect.
Claims (3)
1, a kind of capsule for the treatment of the pain of injury is prepared according to a conventional method by Chinese medicine, it is characterized in that containing in per 1000 capsules the Chinese medicine of following weight:
Radix Notoginseng 200～300g, Sanguis Draxonis 40～80g, Radix Salviae Miltiorrhizae 200～400g, Herba Asari 20～40g, Rhizoma Cyperi (processed) 200～400g, Rhizoma Corydalis 300～500g.
2, the grieved capsule of treatment according to claim 1 is characterized in that containing in per 1000 capsules the Chinese medicine of following weight:
Radix Notoginseng 220～280g, Sanguis Draxonis 50～70g, Radix Salviae Miltiorrhizae 250～350g, Herba Asari 25～35g, Rhizoma Cyperi (processed) 250～350g, Rhizoma Corydalis 350～450g, Poria 250～350g, Pericarpium Citri Reticulatae 250～350g, the Radix Angelicae Dahuricae 160～200g.
3, the grieved capsule of treatment according to claim 2 is characterized in that containing in per 1000 capsules the Chinese medicine of following weight:
Radix Notoginseng 250g, Sanguis Draxonis 60g, Radix Salviae Miltiorrhizae 300g, Herba Asari 30g, Rhizoma Cyperi (processed) 300g, Rhizoma Corydalis 400g, Poria 300g, Pericarpium Citri Reticulatae 300g, Radix Angelicae Dahuricae 180g.
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