CN1298380C - Chinese traditional medicine composition with effects of activating blood circulation, dissipating blood stasis, relaxing, activating the tendons, reducing swelling and easing pain and preparation met - Google Patents
Chinese traditional medicine composition with effects of activating blood circulation, dissipating blood stasis, relaxing, activating the tendons, reducing swelling and easing pain and preparation met Download PDFInfo
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- CN1298380C CN1298380C CNB2004100380882A CN200410038088A CN1298380C CN 1298380 C CN1298380 C CN 1298380C CN B2004100380882 A CNB2004100380882 A CN B2004100380882A CN 200410038088 A CN200410038088 A CN 200410038088A CN 1298380 C CN1298380 C CN 1298380C
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Abstract
The present invention discloses a traditional Chinese medicine composition with the effects of activating blood circulation, dissipating blood stasis, relaxing the tendons, activating the meridian, reducing swelling and relieving pain and a preparation method thereof. The composition is prepared from the raw materials of root of Croton tiglium L., banksia rose, futokadsura stem, ground beeltle, fragrant litsea, Chinese honeylocust abnormal fruit, cortex periplocae, zedoary, small-leaf jointfir, complanate clubmoss herb, yellow cinnamon root or stem, panicled swallowwort root, dalbergia wood, shinyleaf pricklyash root, common lophatherum rhizome and root, sheepear inula herb, giant knotweed rhizome, ecristate corydalis herb, philippine flemingia root, coral ardisia root, membranaceous beautyleaf root, Piper puberulum (Benth.) Maxim., spine aralia root or branchlet and leaf, kusnezoff monkshood root, peppermint camphor and camenthol. The composition can be used for treating knock and fall sprains and fracture dislocation, and eliminating fatigue before and after physical exercises.
Description
Invention field
The present invention relates to a kind of blood circulation promoting and blood stasis dispelling that has, relaxing muscles and tendons and activating QI and blood in the collateral, the Chinese medicine composition of reducing swelling and alleviating pain effect the present invention also relates to the preparation method of this Chinese medicine composition.
Background technology
" Drug Standard of Ministry of Public Health of the Peoples Republic of China-Chinese traditional patent formulation preparation the 18 " 73-74 page or leaf discloses the prescription of bone-setting liquor, and it is to be made by JIULONGCHUAN, the Radix Aucklandiae, Radix seu Caulis fici Martinii, Eupolyphaga Seu Steleophaga, Lignum Aquilariae Resinatum, Fructus Gleditsia, Cortex Acanthopancis, Rhizoma Curcumae, two iron wire, Caulis Entadae, Radix Crotonis Crassifolii, Radix Cynanchi Paniculati, Lignum Dalbergiae Odoriferae, Radix Zanthoxyli, broken bone wood, Herba Inulae cappae, Rhizoma Polygoni Cuspidati, five tastes rattan, Radix Flemingiae Philippinensis, Radix Ardisiae Crenatae, Radix calophylli membranacei, Cauliset Folium Piperis Hancei, Radix araliae armatae, Radix Aconiti Kusnezoffii, Mentholum and Camphora.But the consumption of each component is not disclosed.Disclosing this bonesetting preparation in the CN 1362129A denomination of invention " nano bone-setting preparation medicine and preparation method thereof " is to be made by the Radix Aucklandiae, Caulis Piperis Kadsurae, JIULONGCHUAN, Eupolyphaga Seu Steleophaga, Cortex Periplocae, Rhizoma Curcumae, Caulis Entadae, Lignum Dalbergiae Odoriferae, Radix Zanthoxyli, Radix Flemingiae Philippinensis, Radix Ardisiae Crenatae, Radix calophylli membranacei, Cauliset Folium Piperis Hancei, Radix araliae armatae, Radix Aconiti Kusnezoffii, Mentholum, Camphora, Lignum Aquilariae Resinatum, Fructus Gleditsia, two iron wire, Os Gallus domesticus skin, Radix Cynanchi Paniculati Chinese crude drug.Although disclose the consumption of raw material, some flavour of a drug differences of prescription.The present invention has adjusted prescription and the preferred consumption of each component, has obtained better therapeutic, thereby has finished the present invention.
Goal of the invention
The purpose of this invention is to provide a kind of blood circulation promoting and blood stasis dispelling that has, the Chinese medicine composition of relaxing muscles and tendons and activating QI and blood in the collateral and reducing swelling and alleviating pain effect.
Another object of the present invention provides the preparation method of this Chinese medicine composition.
Summary of the invention
Medicine of the present invention is made up of effective ingredient and/or pharmaceutically acceptable excipient, and wherein said effective ingredient is to be made by the raw material of Chinese medicine of following consumption:
JIULONGCHUAN 1-2 part, Radix Aucklandiae 1-3 part, Caulis Piperis Kadsurae 1-3 part, Eupolyphaga Seu Steleophaga 1-3 part, Radix Litseae 1-3 part, Fructus Gleditsiae Abnormalis 2-4 part, Cortex Periplocae 2-4 part, Rhizoma Curcumae 2-4 part, Caulis Gneti 2-4 part, Caulis Entadae 2-4 part, Radix Cinnamomi porrecti 5-7 part, Radix Cynanchi Paniculati 1-2 part, Lignum Dalbergiae Odoriferae 1-2 part, Radix Zanthoxyli 2-4 part, broken bone wood 2-4 part, Herba Inulae cappae 2-4 part, Rhizoma Polygoni Cuspidati 2-4 part, five tastes rattan 5-7 part, Radix Flemingiae Philippinensis 3-5 part, Radix Ardisiae Crenatae 3-5 part, Radix calophylli membranacei 3-5 part, Cauliset Folium Piperis Hancei 3-5 part, Radix araliae armatae 3-5 part, Radix Aconiti Kusnezoffii 4-6 part, Mentholum 3-5 part and Camphora 3-5 part.
The consumption of preferred feedstock is:
4 parts of 1 part of JIULONGCHUAN, 2 parts of the Radix Aucklandiae, 2 parts of Caulis Piperis Kadsuraes, 2 parts of Eupolyphaga Seu Steleophagas, 2 parts of Radix Litseae, 3 parts of Fructus Gleditsiae Abnormalis, 3 parts of Cortex Periplocaes, 3 parts of Rhizoma Curcumae, 3 parts of Caulis Gnetis, 3 parts of Caulis Entadae, 6 parts of Radix Cinnamomi porrecti, 1 part of Radix Cynanchi Paniculati, 1 part of Lignum Dalbergiae Odoriferae, 3 parts of Radix Zanthoxylis, 3 parts in broken bone wood, 3 parts of Herba Inulae cappae, 3 parts of Rhizoma Polygoni Cuspidati, 6 parts in five tastes rattan, 4 parts of Radix Flemingiae Philippinensiss, 4 parts of Radix Ardisiae Crenataes, 4 parts of Radix calophylli membranacei, 4 parts of Cauliset Folium Piperis Hanceis, 4 parts of Radix araliae armatae, 5 parts of Radix Aconiti Kusnezoffii, 4 parts of Mentholums and Camphoras.
The preparation method of effective ingredient of the present invention is: take by weighing Radix Cynanchi Paniculati, Radix Zanthoxyli, Lignum Dalbergiae Odoriferae and part five tastes rattan four flavors, pulverize separately becomes coarse powder; Take by weighing raw material of Chinese medicine JIULONGCHUAN, the Radix Aucklandiae, Caulis Piperis Kadsurae, Eupolyphaga Seu Steleophaga, Radix Litseae, Fructus Gleditsiae Abnormalis, Cortex Periplocae, Rhizoma Curcumae, Caulis Gneti, Caulis Entadae, Radix Cinnamomi porrecti, broken bone wood, Herba Inulae cappae, Rhizoma Polygoni Cuspidati, Radix Flemingiae Philippinensis, Radix Ardisiae Crenatae, Radix calophylli membranacei, Cauliset Folium Piperis Hancei, Radix araliae armatae and Radix Aconiti Kusnezoffii 20 flavors and residue five tastes rattan, put in the reflux, extract, jar, add alcoholic solution, airtight, after heating and refluxing extraction 6-9 hour, distill, collect distillate; The medicated powder of above-mentioned Radix Cynanchi Paniculati, Radix Zanthoxyli, Lignum Dalbergiae Odoriferae and five tastes rattan four flavors is added in the above-mentioned distillate, stir evenly, dipping is got impregnation liquid, adds Mentholum, Camphora, stirs and makes dissolving, filters, and obtains effective ingredient.
The preparation method of preferred effective ingredient of the present invention is: take by weighing raw material of Chinese medicine Radix Cynanchi Paniculati, Radix Zanthoxyli, Lignum Dalbergiae Odoriferae and 2.5 parts of five tastes rattan four flavors, pulverize separately becomes coarse powder; Take by weighing JIULONGCHUAN, the Radix Aucklandiae, Caulis Piperis Kadsurae, Eupolyphaga Seu Steleophaga, Radix Litseae, Fructus Gleditsiae Abnormalis, Cortex Periplocae, Rhizoma Curcumae, Caulis Gneti, Caulis Entadae, Radix Cinnamomi porrecti, broken bone wood, Herba Inulae cappae, Rhizoma Polygoni Cuspidati, Radix Flemingiae Philippinensis, Radix Ardisiae Crenatae, Radix calophylli membranacei, Cauliset Folium Piperis Hancei, Radix araliae armatae and Radix Aconiti Kusnezoffii 20 flavor and remaining five tastes rattans, put in the reflux, extract, jar, it is an amount of to add ethanol 1000ml and water, airtight, after the heating and refluxing extraction 7 hours, distill, collect the about 1200ml of distillate, with Radix Cynanchi Paniculati, Radix Zanthoxyli, the medicated powder of Lignum Dalbergiae Odoriferae and five tastes rattan four flavors adds in the above-mentioned distillate, stirs evenly, flooded 48 hours, get impregnation liquid, add Mentholum, Camphora stirs and makes dissolving, filter, obtain.
Effective ingredient of the present invention can be prepared into various external preparation such as liquid preparation, spray, membrane, ointment, gel etc. with acceptable accessories.
Medicine of the present invention has the effect of blood circulation promoting and blood stasis dispelling, relaxing muscles and tendons and activating QI and blood in the collateral and reducing swelling and alleviating pain.Can be used for treating osteopatia sprain, fracture, dislocation and sports front and back allaying tiredness.According to " provisions for new drugs approval " with reference to " new Chinese medicine clinical research guideline ", first Affiliated Hospital of Colleges Of Traditional Chinese Medicine Of Guangxi (100 example), Guilin city institute of traditional Chinese medicine (100 example), Yulin City of Guangxi Zhuang Autonomous institute of traditional Chinese medicine (100 example), Yulin City of Guangxi Zhuang Autonomous orthopaedics hospital (100 example) and Guangxi Fangchenggang City Fangcheng District institute of traditional Chinese medicine (100 example) have carried out clinical trial clinical treatment 500 examples year November in May, 2000 to 2000 to bone-setting liquor, treatment acute jerk contused wound clinical recovery rate, obvious effective rate, effective percentage are respectively 68.4%, 26%, 4%, total effective rate 98.4%; Treatment traumatic fracture clinical recovery rate, obvious effective rate, effective percentage are respectively 64%, 28%, 5.2%, and total effective rate is 97.2%.The prompting bone-setting liquor has clinical efficacy preferably to acute jerk contused wound and traumatic fracture.Each clinical symptoms integration comparison shows that symptom and signs such as the conscious pain of acute jerk contused wound, tenderness, swelling, abnormal movement all have clear improvement after the patient before and after the treatment.The prompting bone-setting liquor can significantly improve the various common symptoms of acute jerk contused wound and traumatic fracture.This research has been carried out blood, routine urianlysis and the heart, liver, kidney function test to nearly 410 routine patients, does not all find obvious adverse reaction and toxic and side effects, and prompting this product is clinical safe and reliable.
Medicine of the present invention is a liquid preparation, and its usage and consumption are to dab the affected part with the absorbent cotton dip in liquid medicine; Serious symptom person applied the affected part 1 hour, every day 2～3 times with the drenched absorbent cotton of medicinal liquid.
Specific embodiment
Embodiment 1:
Take by weighing JIULONGCHUAN 10g, Radix Aucklandiae 20g, Caulis Piperis Kadsurae 20g, Eupolyphaga Seu Steleophaga 20g, Radix Litseae 20g, Fructus Gleditsiae Abnormalis 30g, Cortex Periplocae 30g, Rhizoma Curcumae 30g, Caulis Gneti 30g, Caulis Entadae 30g, Radix Cinnamomi porrecti 60g, Radix Cynanchi Paniculati 10g, Lignum Dalbergiae Odoriferae 10g, Radix Zanthoxyli 30g, broken bone wood 30g, Herba Inulae cappae 30g, Rhizoma Polygoni Cuspidati 30g, five tastes rattan 60g, Radix Flemingiae Philippinensis 40g, Radix Ardisiae Crenatae 40g, Radix calophylli membranacei 40g, Cauliset Folium Piperis Hancei 40g, Radix araliae armatae 40g, Radix Aconiti Kusnezoffii 50g, Mentholum 40g and Camphora 40g;
More than 20 Six-element medicines, except that Radix Cynanchi Paniculati, Radix Zanthoxyli, Lignum Dalbergiae Odoriferae, Mentholum, Camphora and part five tastes rattan (2.5 parts), with 20 flavor and remaining five tastes rattans such as all the other JIULONGCHUAN, put in the reflux, extract, jar, add ethanol water, airtight, after the heating and refluxing extraction 7 hours, distill, collect distillate, get Radix Cynanchi Paniculati, Radix Zanthoxyli, Lignum Dalbergiae Odoriferae and five tastes rattan four flavors, pulverize separately becomes coarse powder, adds in the above-mentioned distillate, stirs evenly, flooded 48 hours, get impregnation liquid, add Mentholum, Camphora, stir and make dissolving, filter, adjust total amount to 1000ml.This medicine claims bone-setting liquor again.
Embodiment 2:
Take by weighing JIULONGCHUAN 20g, Radix Aucklandiae 10g, Caulis Piperis Kadsurae 10g, Eupolyphaga Seu Steleophaga 30g, Radix Litseae 10g, Fructus Gleditsiae Abnormalis 40g, Cortex Periplocae 20g, Rhizoma Curcumae 40g, Caulis Gneti 20g, Caulis Entadae 20g, Radix Cinnamomi porrecti 50g, Radix Cynanchi Paniculati 20g, Lignum Dalbergiae Odoriferae 10g, Radix Zanthoxyli 20g, broken bone wood 40g, Herba Inulae cappae 20g, Rhizoma Polygoni Cuspidati 40g, five tastes rattan 50g, Radix Flemingiae Philippinensis 30g, Radix Ardisiae Crenatae 50g, Radix calophylli membranacei 30g, Cauliset Folium Piperis Hancei 30g, Radix araliae armatae 30g, Radix Aconiti Kusnezoffii 60g, Mentholum 50g and Camphora 50g.
Preparation process is with embodiment 1.
Embodiment 3:
Take by weighing JIULONGCHUAN 20g, Radix Aucklandiae 30g, Caulis Piperis Kadsurae 10g, Eupolyphaga Seu Steleophaga 30g, Radix Litseae 20g, Fructus Gleditsiae Abnormalis 20g, Cortex Periplocae 40g, Rhizoma Curcumae 20g, Caulis Gneti 20g, Caulis Entadae 20g, Radix Cinnamomi porrecti 70g, Radix Cynanchi Paniculati 10g, Lignum Dalbergiae Odoriferae 10g, Radix Zanthoxyli 20g, broken bone wood 40g, Herba Inulae cappae 20g, Rhizoma Polygoni Cuspidati 20g, five tastes rattan 70g, Radix Flemingiae Philippinensis 30g, Radix Ardisiae Crenatae 30g, Radix calophylli membranacei 30g, Cauliset Folium Piperis Hancei 30g, Radix araliae armatae 30g, Radix Aconiti Kusnezoffii 60g, Mentholum 30g and Camphora 50g;
Preparation process is with embodiment 1.
The main pharmacodynamics research of test example 1 bone-setting liquor
Material:
1. tried thing and medicine: (1) bone-setting liquor, (agent contains ethanol 55%), and lot number 970503, Yulin Pharmaceutic Factory, Gangxi Autonomous Region's (promptly showing Yulin Pharmaceutical Co., Ltd., Guangxi) provides; (2) BOGU SHUI, Guangdong are defended the accurate word of medicine (85) E-053, lot number 961208, and the Guangdong white crane pharmaceutical factory of traditional Chinese medicine produces; (3) bone setting tablet, the Liao Dynasty defends the accurate word of medicine (83) 1416-27, lot number 9509119, the DaLian, China pharmaceutical factory of traditional Chinese medicine produces.
2. animal: mice, Kunming kind, regular grade, body weight 20～24g; Rat, SD, regular grade, body weight 220～300g, white hair rabbit, body weight 1.5～2.0kg, being animal housing of Guangxi Medical University provides.Animal male and female dual-purpose.
Experimental technique and result
1. to the influence of fracture healing in rats effect
Rat use in experiment, and every rat is right back to move back the inside doubling in stage casing and cause fracture for 90 °, does not all fix random packet: (1) normal control group (being coated with distilled water outward); (2) solvent matched group (being coated with solvent outward); (3) the bone setting tablet group (0.7g/kg, ig); (4) BOGU SHUI group (being coated with BOGU SHUI outward); Bone-setting liquor low dose group (being coated with 50% bone-setting liquor outward) (6) bone-setting liquor high dose group (being coated with bone-setting liquor outward).Began administration the same day after the random packet.Medication: except that the bone setting tablet gastric infusion, all the other liquid medicine of exterior coating 1ml, once a day.All group successive administrations 30 days.
Put to death animal in the 30th day, strip right femur, place 10% formaldehyde, after strike off muscle around it, reference method is directly measured the fracture resistence force (fracture site is shifted, causes fracture to be angulation deformity person and disregard) of fracture.The result shows, the bone-setting liquor high dose group has the trend of raising effect to fracture resistence force, and prompting has certain facilitation to fracture healing in rats, sees Table 1.
Table 1 bone-setting liquor is to the influence of rat fracture fracture resistence force
| Group | Number of animals | Doubling power |
| Normal control group solvent matched group bone setting tablet BOGU SHUI bone-setting liquor hangs down amount group bone-setting liquor a large amount group | 6 6 8 7 6 6 | 2.88±1.20 2.82±1.03 * 4.81±1.57 **ΔΔ 3.40±1.41 *Δ 3.181±.20 *Δ 3.80±1.24 *Δ |
Compare with the normal control group,
*P＞0.05,
*P＜0.05
Compare Δ P＞0.05, Δ Δ P＜0.05 with the solvent matched group
2, to the influence of local stasis of blood
Rabbit is used in experiment, and every subcutaneous 0.15ml rabbit anticoagulated blood of injecting in rabbit ear middle part makes the local circular congestion speckle that forms.Measure congestion speckle area, animal random packet: (1) normal control group (being coated with distilled water outward); (2) solvent matched group (being coated with solvent outward); (3) positive controls (being coated with BOGU SHUI outward); (4) bone-setting liquor low dose group (being coated with 25% bone-setting liquor outward); (5) dosage group (being coated with 50% bone-setting liquor outward) in the bone-setting liquor; (6) bone-setting liquor high dose group (being coated with bone-setting liquor stock solution outward).Begin administration, medication after the animal grouping: in the liquid medicine of exterior coating 0.5ml of ecchymosis place, every day 3 times.Continuous 5 days, measured the ecchymosis area respectively in the 3rd day, the 6th day.Ecchymosis area discrepancy between comparable group.
The result shows that dosage, high dose group can obviously be dwindled the ecchymosis area in the bone-setting liquor, show the absorption that can promote local congestion, see Table 2
Table 2 bone-setting liquor is to the influence of rabbit ear congestion
| Group is moving | The thing number | Congestion speckle area | ||
| Before the medicine | The 3rd day | The 6th day | ||
| Over against contrast dosage bone-setting liquor high dose in the BOGU SHUI bone-setting liquor low dosage bone-setting liquor according to solvent | 7 7 7 7 7 7 | 2.41±0.40 2.43±0.38 * 2.40±0.37 * 2.43±0.35 * 2.40±0.37 * 2.42±0.3 * | 1.90±0.40 1.74±0.31 * 1.50±0.30 *Δ 1.70±0.34 *Δ 1.51±0.40 *Δ 1.41±0.33 **Δ | 1.02±0.50 0.86±0.40 * 0.51±0.23 **Δ 0.70±0.30 *Δ 0.54±0.21 **Δ 0.42±0.20 **Δ |
Compare with the normal control group,
*P＞0.05,
*P＜0.05
Compare Δ P＞0.05 with the solvent matched group
3, on Carrageenan causes the influence of mice toes inflammation
72 of mices, every right back toes aponeurosis (aponeuroses) of mice is injected 1% carrageenin (sterile saline preparation), 25 μ l down.Animal random packet: (1) normal control group (immersion distilled water); (2) solvent matched group (immersion solvent); (3) positive controls (immersion BOGU SHUI); (4) bone-setting liquor low dose group (soaking 25% bone-setting liquor); (5) dosage group (soaking 50% bone-setting liquor) in the bone-setting liquor; (6) bone-setting liquor high dose group (immersion bone-setting liquor).Begin administration after the grouping.Respectively at causing administration in scorching back 1 hour, 3 hours, 6 hours 1 time, medication: each soaking medicated liquid 1 minute.Put to death animal in 7 hours behind the Yu Zhiyan, biped behind the clip is equal to part from the most advanced and sophisticated supreme 15mm of middle toe with sharp scalpel shearing, accurately weigh, with about sufficient weight difference as inflammation swelling degree.
The result shows that the bone-setting liquor high dose group has tangible antiinflammatory action, sees Table 3.
The influence of table 3 bone-setting liquor on Carrageenan inflammation
| Group | Number of animals | The swelling degree |
| Dosage bone-setting liquor high dose in the normal control group solvent matched group BOGU SHUI group bone-setting liquor low dosage bone-setting liquor | 12 12 12 12 12 12 | 85.0±18.5 84.2±20.6 * 66.8±17.8 **ΔΔ 78.6±15.6 *Δ 70.6±20.1 *Δ 64.9±13.1 **ΔΔ |
Compare with the normal control group,
*P＞0.05,
*P＜0.05
Compare Δ P＞0.05, Δ Δ P＜0.05 with the solvent matched group
4, analgesic activity
Get 60 of mices, divide 6 groups at random: (1) normal control group (being coated with distilled water outward); (2) solvent matched group (being coated with solvent outward); (3) positive controls (being coated with BOGU SHUI outward); (4) bone-setting liquor low dose group (being coated with 25% bone-setting liquor outward); (5) dosage group (being coated with 50% bone-setting liquor outward) in the bone-setting liquor; (6) bone-setting liquor high dose group (being coated with bone-setting liquor stock solution outward).Medication: every each liquid medicine of exterior coating 0.5ml of mouse web portion both sides.10 minutes every mouse peritoneals are injected 0.6% acetic acid 0.2ml after the administration, observe after injecting acetic acid the writhing response number of (in promptly 20 minutes) in 5 minutes to 25 minutes.
The result shows that bone-setting liquor has significant analgesia role, can significantly suppress pain caused of acetic acid and answer, and sees Table 4.
The analgesic activity of table 4 bone-setting liquor (writhing method)
| Group | Number of animals | Turn round the body number of times |
| Normal control group solvent matched group | 10 10 | 35.8±8.2 36.5±7.3 * |
| Dosage bone-setting liquor high dose in the BOGU SHUI bone-setting liquor low dosage bone-setting liquor | 10 10 10 10 | 19.3±9.7 ***ΔΔΔ 9.8±3.0 ***ΔΔΔ 2.7±2.2 ***ΔΔΔ 2.2±2.1 ***ΔΔΔ |
Compare with the normal control group,
*P＞0.05,
*P＜0.05
Compare Δ Δ Δ P＜0.01 with the solvent matched group
Conclusion
Zoopery is the result show, bone-setting liquor has the healing of promotion effect to fracture, and can promote congestion to absorb, externally wound the congestion edema that causes the obvious treatment effect is also arranged, the inflammation that on Carrageenan causes also has tangible antiinflammatory action, the pain that Dichlorodiphenyl Acetate causes also has analgesic activity, the prompting bone-setting liquor have invigorate blood circulation, effects such as blood stasis dispelling, synthetism, antiinflammatory, pain relieving, be used for osteopatia sprain for it is clinical and fracture provides certain experimental basis.
Test example 2 bone-setting liquor treatment acute jerk contused wound, traumatic fracture clinical trial final report
Object and method
One, diagnostic criteria
(1) acute jerk contused wound
1, tangible trauma history is arranged, the course of disease is in 3 days.
2, sprain to indirect violence makes the joint and surpass the damage of normal limit, can make the ligament, tendon and the joint capsule that are attached to the joint produce part and tear.Often occur in ankle joint, articulations digitorum manus and lumbar vertebra, show as and hinder the back sharp ache, swelling, ecchymosis and joint movement disorder appear rapidly in the part.
3, dampen to the blunt strike or the damage of the subcutaneous tissue muscle due to colliding.Show as traumatic part pain, swelling, cyanosis of the skin, hematoma and tenderness.Weight person has fascia, muscle fiber to tear or the deep hematoma.
4, 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) traumatic fracture:
1, direct or indirect trauma history is arranged.
2, General Symptoms: and the simple fracture of acomia disease, General Symptoms is very unobvious or not serious; Shock can take place or merge visceral organ injury in serious wound, combined injury; But open fracture concurrent infection, or concurrent neurovascular damage.
3, local symptom: pain and tenderness, local swelling, dysfunction, deformity, abnormal movement, bony crepitus.
4, X ray examination: fracture diagnosis that can be clear and definite, confirm localized variation such as classification of fracture, direction of displacement, fracture form, and get rid of pathologisch Bruch.
The case choice criteria:
(1), include standard in:
1, acute jerk contused wound: meet the acute jerk contused wound standard, the course of disease is no more than 3 days persons can include the test case in.
2, traumatic fracture: hinder the fresh closed fracture patient who goes to a doctor in 3 weeks the back and all can include the object of observation in.
(2), exclusion standard (comprising inadaptation or rejecting standard):
1, the age is at under-18s or over-65s, trimester of pregnancy or women breast-feeding their children, allergic constitution or to this medicine allergy sufferers.
2, be associated with that soft tissues such as muscle, tendon, ligament rupture fully and acute the turning round of nerve injury complication decreased the wounded.
3, by the pathologisch Bruch person due to the factors such as tumor.
4, be associated with serious primary disease such as cardiovascular, cerebrovascular, liver, kidney and hemopoietic system, psychotic.
5, 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.
Three, clinical trial method:
(1) EXPERIMENTAL DESIGN: adopt own control, opening, multicenter to test.
(2) basic demand: the test case adopts inpatient and clinic case, and clinic case should strict control variable factor.
(3) medication:
1, acutely turns round damage: gently put the affected part in right amount on the skin with the absorbent cotton dip in liquid medicine, rubbing, every day 3 times (early, middle and late).5 days courses of treatment.
2, traumatic fracture: soak cotton pad (soaking degree of being), soak affected part 1 hour, every day 3 times with the cotton pad with medicinal liquid.4 weeks of the course of treatment.
(4) observational technique:
1, acutely turn round damage: routine is made detailed physical examination and affected part X line is taken the photograph sheet before the test.Each was with examining once inquiry medicining condition, the state of an illness and side effect such as record damage local swelling, congestion, pain and joint function disturbance in the 1st, 3,5 day in the test back.
2, traumatic fracture: routine is made detailed physical examination before the test, does the fractures bit line and takes the photograph sheet.Weekly with examining 1 time, observe tenderness, vertically kowtow pain and swelling and begin the time and the side effects of pharmaceutical drugs that alleviate and disappear after the test.Fracture site was taken the photograph the sheet check when finished the course of treatment.
3, viewing duration damage is local can give suitable braking or fixing, and the fracture part can be given and be resetted and fix.Also can raise and hinder limb, alleviate swelling and pain, but can not use hot compress, physical therapy or other externals blood circulation promoting and blood stasis dispelling for oral administration, reducing swelling and alleviating pain medicine to promote venous return, to improve local blood circulation.Therapeutic effect is evaluated with scoring method.The curative effect judgement is directly made by the observer.
Four, observation index:
(1) safety observation:
1, general physical examination.
2, routine blood test, routine urinalysis, stool are checked.
3, cardiac function (electrocardiogram), liver function (ALT), renal function (Cr, BUN).
(2) health giving quality is observed:
1, acute jerk contused wound:
(1) sprains variations such as local swelling, congestion, pain and function of joint barrier.
(2) variation of picture of the tongue and pulse condition.
(3) the improvement time and the effect of pain.
2, traumatic fracture:
(1) Gu Zhe position, type, displacement situation, to configuration state, and swelling of fracture site, pain, active situation etc.
(2) General Symptoms, picture of the tongue, pulse condition.
(3) growth of spur situation.
(4) sx and extinction time.
Five, efficacy assessment standard:
1, acute jerk contused wound
(1) recovery from illness: functional activity recovers normal; Therapeutic index＞more than 90%.
(2) produce effects: functional activity recovers substantially; Therapeutic index is between 61～90%.
(3) effective: functional activity has improvement; Therapeutic index is between 31～60%.
(4) invalid: do not reach above standard, therapeutic index is below＜31%.
2, traumatic fracture
(1) recovery from illness: local no tenderness, there is not the pain of vertically tunking, no local anomaly activity; The X skiagram shows that fracture line is fuzzy, has the seriality callus to pass through fracture line; Curative effect index＞more than 90%.
(2) produce effects: symptom, sign are clearly better; The X skiagram shows that fracture line is fuzzy, has obvious callus formation; Curative effect index is between 61～90%
(3) effective: symptom, sign have improvement; The X skiagram shows that callus formation is not obvious; Therapeutic index is between 31～60%.
(4) invalid: do not reach above standard, therapeutic index is below＜31%.
Six, statistical procedures: enumeration data is used and is checked with check, measurement data.
The result
One, physical data: among the 500 routine qualified experimenters, acute jerk contused wound 250 examples, traumatic fracture 250 examples; Inpatient's 247 examples, outpatient's 253 examples; Male's 282 examples, women's 218 examples; Maximum 65 years old age, minimal ages 18 years old, 45.21 ± 10.75 years old mean age; Acute jerk contused wound average course of disease 1.62 ± 0.83 days, traumatic fracture average course of disease 2.13 ± 1.15 days.
Two, curative effect:
Subordinate list 5 curative effect situation (units: example)
| The example number | Recovery from illness (%) | Produce effects (%) | Effectively (%) | Invalid (%) | Total effectively (%) | |
| Acute turning round frustrated folded traumatic fracture | 250 250 | 171(68.40) 160(64.0) | 65(26.00) 70(28.00) | 10(4.00) 13(5.20) | 4(1.60) 7(2.80) | 246(98.4) 243(97.20) |
Three, to the improvement effect of symptom and sign:
Respectively see improvement after the comparison (check) of disease integration and the medication, disappearance situation before and after subordinate list 6 treatment:
| The example number | Before the treatment | After the treatment | Improve (improvement rate) | Disappear (disappearance rate) | |
| The conscious pain tenderness of acute jerk contused wound swelling ecchymosis moving obstacle | 250 250 250 228 206 213 | 2.5±0.59 2.48±0.62 2.16±0.72 1.67±0.94 1.96±0.93 | 0.31±1.15 0.33±0.47 0.29±0.40 0.35±0.45 0.30±0.53 | 250(100％) 250(100％) 228(100％) 206(100％) 213(100％) | 238(95.20％) 230(92.00％) 218(95.61％) 182(88.35％) 184(86.38％) |
| The traumatic fracture tenderness is indulged and is kowtowed pain swelling abnormal movement | 250 250 250 229 200 | 2.78±0.41 2.64±0.60 2.59±0.72 2.26±1.15 | 0.81±0.36 0.23±0.40 0.19±0.31 0.18±0.30 | 250(100％) 250(100％) 229(100％) 200(100％) | 234(93.60％) 226(90.40％) 203(88.64％) 185(92.50％) |
Annotate:, P＜equal 0.05 before and after the treatment, and difference has the significance meaning.
Four, the onset time of cardinal symptom after the medication:
Treatment acute jerk contused wound pain on average began to alleviate in 1.39 ± 0.83 days; Swelling on average began to alleviate in 1.58 ± 0.94 days.
The treatment traumatic fracture, tenderness on average began to alleviate in 4.49 ± 4.29 days; Kowtowing pain on average began to alleviate in 5.90 ± 5.37 days; Swelling on average began to alleviate in 4.43 ± 3.54 days.
Five, the extinction time of cardinal symptom after the medication:
The treatment acute jerk contused wound, pain on average disappeared in 4.45 ± 1.23 days; Swelling on average disappeared in 4.01 ± 1.31 days.
The treatment traumatic fracture, tenderness on average disappeared in 11.68 ± 9.95 days; Kowtowing pain on average disappeared in 18.73 ± 8.23 days; Swelling on average disappeared in 13.65 ± 6.98 days.
Six, safety detects:
1, routine blood test: detected 413 examples before the treatment, wherein, there is no unusual in the 413 example treatment back checks of normal range.
2, routine urinalysis: detected 413 examples before the treatment, wherein, there is no unusual in the 413 example treatment back checks of normal range.
3, electrocardiogram: detected 413 examples before the treatment, wherein, there is no unusual in the 413 example treatment back checks of normal range.
4, ALT: detected 375 examples before the treatment, wherein, there is no unusual in the 375 example treatment back checks of normal range.
5, Cr: detected 369 examples before the treatment, wherein, there is no unusual in the 369 example treatment back checks of normal range.
6, BUN: detected 369 examples before the treatment, wherein, there is no unusual in the 369 example treatment back checks of normal range.
Seven, untoward reaction is observed:
Slight erythra, local pruritus symptom appearred in the part after viewing duration had 15 routine patient's medications, and its incidence rate is 3%, and transference cure after using medicine antiallergic symptomatic treatments such as fluocinonide ointment or PIKANG SHUANG need not be treated in drug withdrawal, and observation and efficacy evaluation are not had influence.
Claims (6)
1, a kind of have a blood circulation promoting and blood stasis dispelling, the Chinese medicine composition of relaxing muscles and tendons and activating QI and blood in the collateral and reducing swelling and alleviating pain effect, form by effective ingredient and/or pharmaceutically acceptable excipient, wherein make described raw materials of effective components and consist of: JIULONGCHUAN 1-2 part, Radix Aucklandiae 1-3 part, Caulis Piperis Kadsurae 1-3 part, Eupolyphaga Seu Steleophaga 1-3 part, Radix Litseae 1-3 part, Fructus Gleditsiae Abnormalis 2-4 part, Cortex Periplocae 2-4 part, Rhizoma Curcumae 2-4 part, Caulis Gneti 2-4 part, Caulis Entadae 2-4 part, Radix Cinnamomi porrecti 5-7 part, Radix Cynanchi Paniculati 1-2 part, Lignum Dalbergiae Odoriferae 1-2 part, Radix Zanthoxyli 2-4 part, broken bone wood 2-4 part, Herba Inulae cappae 2-4 part, Rhizoma Polygoni Cuspidati 2-4 part, five tastes rattan 5-7 part, Radix Flemingiae Philippinensis 3-5 part, Radix Ardisiae Crenatae 3-5 part, Radix calophylli membranacei 3-5 part, Cauliset Folium Piperis Hancei 3-5 part, Radix araliae armatae 3-5 part, Radix Aconiti Kusnezoffii 4-6 part, Mentholum 3-5 part and Camphora 3-5 part.
2, according to the described Chinese medicine composition of claim 1, wherein make described raw materials of effective components and consist of: 4 parts of 1 part of JIULONGCHUAN, 2 parts of the Radix Aucklandiae, 2 parts of Caulis Piperis Kadsuraes, 2 parts of Eupolyphaga Seu Steleophagas, 2 parts of Radix Litseae, 3 parts of Fructus Gleditsiae Abnormalis, 3 parts of Cortex Periplocaes, 3 parts of Rhizoma Curcumae, 3 parts of Caulis Gnetis, 3 parts of Caulis Entadae, 6 parts of Radix Cinnamomi porrecti, 1 part of Radix Cynanchi Paniculati, 1 part of Lignum Dalbergiae Odoriferae, 3 parts of Radix Zanthoxylis, 3 parts in broken bone wood, 3 parts of Herba Inulae cappae, 3 parts of Rhizoma Polygoni Cuspidati, 6 parts in five tastes rattan, 4 parts of Radix Flemingiae Philippinensiss, 4 parts of Radix Ardisiae Crenataes, 4 parts of Radix calophylli membranacei, 4 parts of Cauliset Folium Piperis Hanceis, 4 parts of Radix araliae armatae, 5 parts of Radix Aconiti Kusnezoffii, 4 parts of Mentholums and Camphoras.
3, the preparation method of claim 1 or 2 described Chinese medicine compositions is characterized in that the preparation method of effective ingredient is: take by weighing Radix Cynanchi Paniculati, Radix Zanthoxyli, Lignum Dalbergiae Odoriferae and part five tastes rattan four flavors, pulverize separately becomes coarse powder; Take by weighing raw material of Chinese medicine JIULONGCHUAN, the Radix Aucklandiae, Caulis Piperis Kadsurae, Eupolyphaga Seu Steleophaga, Radix Litseae, Fructus Gleditsiae Abnormalis, Cortex Periplocae, Rhizoma Curcumae, Caulis Gneti, Caulis Entadae, Radix Cinnamomi porrecti, broken bone wood, Herba Inulae cappae, Rhizoma Polygoni Cuspidati, Radix Flemingiae Philippinensis, Radix Ardisiae Crenatae, Radix calophylli membranacei, Cauliset Folium Piperis Hancei, Radix araliae armatae and Radix Aconiti Kusnezoffii 20 flavors and residue five tastes rattan, put in the reflux, extract, jar, add alcoholic solution, airtight, after heating and refluxing extraction 6-9 hour, distill, collect distillate; The medicated powder of above-mentioned Radix Cynanchi Paniculati, Radix Zanthoxyli, Lignum Dalbergiae Odoriferae and five tastes rattan four flavors is added in the above-mentioned distillate, stir evenly, dipping is got impregnation liquid, adds Mentholum, Camphora, stirs and makes dissolving, filters, and obtains effective ingredient.
4, the preparation method of Chinese medicine composition according to claim 3 is prepared into liquid preparation for external application, spray, membrane, ointment or gel with effective ingredient and acceptable accessories.
5, the preparation method of Chinese medicine composition according to claim 3, the effective ingredient preparation method that it is characterized in that medicine is for taking by weighing raw material of Chinese medicine Radix Cynanchi Paniculati, Radix Zanthoxyli, Lignum Dalbergiae Odoriferae and 2.5 parts of five tastes rattans, and pulverize separately becomes coarse powder; Take by weighing JIULONGCHUAN, the Radix Aucklandiae, Caulis Piperis Kadsurae, Eupolyphaga Seu Steleophaga, Radix Litseae, Fructus Gleditsiae Abnormalis, Cortex Periplocae, Rhizoma Curcumae, Caulis Gneti, Caulis Entadae, Radix Cinnamomi porrecti, broken bone wood, Herba Inulae cappae, Rhizoma Polygoni Cuspidati, Radix Flemingiae Philippinensis, Radix Ardisiae Crenatae, Radix calophylli membranacei, Cauliset Folium Piperis Hancei, Radix araliae armatae and Radix Aconiti Kusnezoffii 20 flavor and remaining five tastes rattans, put in the reflux, extract, jar, add alcoholic solution, airtight, after the heating and refluxing extraction 7 hours, distill, collect distillate, with above-mentioned Radix Cynanchi Paniculati, Radix Zanthoxyli, the medicated powder of Lignum Dalbergiae Odoriferae and five tastes rattan four flavors adds in the above-mentioned distillate, stirs evenly, dipping, get impregnation liquid, add Mentholum, Camphora stirs and makes dissolving, filter, obtain.
6, the preparation method of Chinese medicine composition according to claim 5 is prepared into liquid preparation for external application, spray, membrane, ointment or gel with effective ingredient and acceptable accessories.
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| CN101336993B (en) * | 2008-07-24 | 2011-02-09 | 广西源安堂药业有限公司 | External tincture for treating wind-dampness arthralgia and urgent sprain and preparation method thereof |
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| CN106620618A (en) * | 2016-12-30 | 2017-05-10 | 深圳大医传承健康管理有限公司 | Medicine for conditioning Yang deficiency type habitus and preparation method thereof |
| CN106511912A (en) * | 2016-12-30 | 2017-03-22 | 深圳大医传承健康管理有限公司 | Medicine for conditioning vital energy stagnation type physique and preparation method of medicine |
| CN106822776A (en) * | 2016-12-30 | 2017-06-13 | 深圳大医传承健康管理有限公司 | A kind of medicine for nursing one's health qi-deficiency type constitution and preparation method thereof |
| CN111529663A (en) * | 2020-05-19 | 2020-08-14 | 五华县张焕全医药科技有限公司 | Traditional Chinese medicine preparation for treating lumbar pain and preparation method thereof |
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| CN1362129A (en) * | 2001-01-04 | 2002-08-07 | 杨孟君 | Nano bone-setting medicine and its preparation |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1362129A (en) * | 2001-01-04 | 2002-08-07 | 杨孟君 | Nano bone-setting medicine and its preparation |
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