CN1966066A - Ointment for unblocking collaterals and relieving pain and preparation process threreof - Google Patents
Ointment for unblocking collaterals and relieving pain and preparation process threreof Download PDFInfo
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Abstract
The invention relates to a medicinal grease for relaxing vein and removing pain, and process for preparation, wherein the grease is prepared from Chinese angelica root, Ligusticum wallichii, safflower, Resurrectionlily rhizome, pricklyash peel, piper nigrum, clove, Cinnamomum cassia, long pepper, dried ginger, rhubarb horsetails, camphor, baras camphor and mentha-camphor through steps of disintegrating, impregnating with ethanol, carrying out diacolation, charging gasoline for abstraction, separating ethanol, obtaining extract oil, subjecting Cinnamomum cassia to ethanol diacolation, extracting with gasoline, percolating extracted medicinal dross with ethanol, collecting the percolation liquid, obtaining extract through decompression and concentration, making base material from rubber, colophony, Vaseline, fluid wax, zinc oxide, dimethyl sulfoxide and gasoline, charging concrete, extractive oil and camphor, mixing homogeneously and applying onto base fabrics.
Description
One, technical field
The present invention relates to be used for the treatment of clinically a kind of activating meridians to stop pain cream and the production method thereof of osseous arthritis.
Two, background technology
Osseous arthritis is a kind of common frdquently encountered disease, and clinical manifestation is joint sting or localized pain, joint stuffiness, local fear of cold, limbs are weighing, and pain alleviated while getting warmth or chance are cold to be increased the weight of, local swelling, dark tongue quality have petechia or ecchymosis, Tai Bai or greasy, belonging to blood stasis stagnates, cold dampness accumulation pattern rheumatism involving the bone disease, how not lived by QI and blood, meridians are obstructed and cause, and are more common in be overworked for a very long period for a long time history and person in middle and old age, this disease of treatment is removed physical therapy at present, massage, outside the means such as operation, also adopt Drug therapy, the therefore sick chronic disease of amassing for a long time that belongs to, the Western medicine curative effect is not good enough, and Chinese medicine, as sky and the logical card of bone, treatment can not be satisfied people's needs again, though a kind of activating meridians to stop pain cream is now arranged, but, in preparation, also there is deficiency, therefore because prescription amount proportioning is unreasonable, pharmaceutical effectiveness is unsatisfactory, and its improvement is imperative.
Three, summary of the invention
At above-mentioned situation, the present invention's purpose just provides new a kind of activating meridians to stop pain cream and the production method thereof of treatment osseous arthritis, effectively solve the medication problem that is used for the treatment of osseous arthritis, the technical scheme of its solution is, employing is made by effective Chinese medicine of following weight meter: Radix Angelicae Sinensis, Rhizoma Chuanxiong, Flos Carthami, Rhizoma Kaempferiae, Pericarpium Zanthoxyli, Fructus Piperis, Flos Caryophylli, Cortex Cinnamomi, Fructus Piperis Longi, Rhizoma Zingiberis, Radix Et Rhizoma Rhei, Camphora, Borneolum Syntheticum and Mentholum, its production method is, with Radix Angelicae Sinensis, Rhizoma Chuanxiong, Flos Carthami, Rhizoma Kaempferiae, Pericarpium Zanthoxyli, Fructus Piperis, Flos Caryophylli, Cortex Cinnamomi, Fructus Piperis Longi, Rhizoma Zingiberis is after powder becomes coarse powder respectively with Radix Et Rhizoma Rhei, except that Cortex Cinnamomi, merging all the other ten flavor medicated powder mixes, carry out percolation with percolation, use alcohol dipping earlier, carry out percolation again, collect percolate, add industrial naptha extraction 3 times, separating alcohol must extract fluid, again Cortex Cinnamomi is used ethanol percolation separately, use gasoline extraction, collect extraction fluid, two kinds of extraction fluid with volume ratio mix at 9: 1 (be Cortex Cinnamomi extraction fluid account for total liquid measure 1/10th) standby; The above-mentioned medicinal residues that must extract behind the fluid are used ethanol percolation more respectively, and Cortex Cinnamomi is still used ethanol percolation separately, collect percolate, merge two kinds of percolates with 9: 1 ratio of volume, and concentrating under reduced pressure becomes extractum, and is standby; Get rubber, Colophonium, vaseline, liquid paraffin, zinc oxide, dimethyl sulfoxide and gasoline are made substrate, after removing static, add above-mentioned extractum, extraction fluid and Camphora, Borneolum Syntheticum and Mentholum mix to be beaten evenly, be applied on the base fabric, cover lining, section, prescription of the present invention is scientific and reasonable, production method advanced person is by existing " vapor distillation, ethanol percolation ", change the process of " ethanol percolation; gasoline extraction " into, the independent percolation of Cortex Cinnamomi mixes with other drug again, has kept effective ingredient to greatest extent, improved curative effect, having guaranteed the quality of product, is that clinical meaning is huge to existing production activating meridians to stop pain cream (claiming bony spur peaceful plaster again) creationary innovation and improvement.
Four, the specific embodiment
Below in conjunction with practical situation, the specific embodiment of the present invention is elaborated.
The present invention is made by following Chinese medicine, Radix Angelicae Sinensis 105-200g, Rhizoma Chuanxiong 65-85g, Flos Carthami 65-100g, Rhizoma Kaempferiae 50-60g, Pericarpium Zanthoxyli 70-85g, Fructus Piperis 70-85g, Flos Caryophylli 35-40g, Cortex Cinnamomi 40-60g, Fructus Piperis Longi 50-60g, Rhizoma Zingiberis 55-60g, Radix Et Rhizoma Rhei 55-60g, Camphora 45-60g, Borneolum Syntheticum 30-40g, Mentholum 30-40g;
Also can make: Radix Angelicae Sinensis 110g, Rhizoma Chuanxiong 66g, Flos Carthami 68g, Rhizoma Kaempferiae 52g, Pericarpium Zanthoxyli 72g, Fructus Piperis 72g, Flos Caryophylli 36g, Cortex Cinnamomi 45g, Fructus Piperis Longi 52g, Rhizoma Zingiberis 56g, Radix Et Rhizoma Rhei 56g, Camphora 46g, Borneolum Syntheticum 31g, Mentholum 31g by following Chinese medicine;
Or make: Radix Angelicae Sinensis 190g, Rhizoma Chuanxiong 80g, Flos Carthami 90g, Rhizoma Kaempferiae 68g, Pericarpium Zanthoxyli 82g, Fructus Piperis 80g, Flos Caryophylli 39g, Cortex Cinnamomi 55g, Fructus Piperis Longi 55g, Rhizoma Zingiberis 58g, Radix Et Rhizoma Rhei 58g, Camphora 55g, Borneolum Syntheticum 38g, Mentholum 38g by following Chinese medicine.
Its production method is: earlier Radix Angelicae Sinensis 105-200g, Rhizoma Chuanxiong 65-85g, Flos Carthami 65-100g, Rhizoma Kaempferiae 50-60g, Pericarpium Zanthoxyli 70-85g, Rhizoma Zingiberis 55-60g, Fructus Piperis 70-85g, Flos Caryophylli 35-40g, Radix Et Rhizoma Rhei 55-60g, Fructus Piperis Longi 50-60g is ground into coarse powder, and (pulverizing the back separately mixes, or lump together pulverizing all can), according to the percolation under fluid extract and the extractum item (appendix IO of Chinese Pharmacopoeia nineteen ninety-five version), with mass concentration is 90% alcohol dipping percolation after 24 hours, collect percolate 1000-2000ml, medicinal residues add industrial naptha extraction 3 times again, the gasoline addition is the 400-800ml first time, second, be 200-400ml (addition is generally about the 1/4-1/2 of percolate volume) for the third time, must extract fluid, after Cortex Cinnamomi 40-60g pulverizes separately, with mass concentration is that 90% ethanol floods percolation after 24 hours, collect percolate 100-200ml, with gasoline extraction 3 times, add for the first time gasoline 40-80ml, second, respectively be 20-40ml for the third time, must extract fluid, two kinds of fluid mixes with 9: 1 volume ratio, and is standby; The above-mentioned two kinds of medicinal residues behind the extraction oil, be that 70% ethanol carries out percolation with mass concentration respectively again, collect the medicinal residues percolate 2250-4500ml of Radix Angelicae Sinensis, Rhizoma Chuanxiong, Flos Carthami, Rhizoma Kaempferiae, Pericarpium Zanthoxyli, Fructus Piperis, Flos Caryophylli, Fructus Piperis Longi, Rhizoma Zingiberis and Radix Et Rhizoma Rhei, Cortex Cinnamomi medicinal residues percolate 250-500ml, merge two kinds of percolates (volume ratio is 9: 1), be evaporated to 80 ℃ and measure down that relative densities are not less than 1.20, water content is no more than 18.0% extractum, standby; After getting rubber cream 285-570g, Colophonium 268-536g, zinc oxide 355-710g, vaseline 29-58g, lanoline 68-136g, liquid paraffin 18-36g, dimethyl sulfoxide 10-20g, gasoline 1200-2400ml and making substrate and remove static, add above-mentioned extractum, extraction fluid and above-mentioned Camphora, Borneolum Syntheticum and Mentholum, mix and beat evenly, be applied on the base fabric, cover and mend layer, section required activating meridians to stop pain cream.Can make the activating meridians to stop pain cream of any amount by above component and method.
The present invention also by: earlier Radix Angelicae Sinensis 110g, Rhizoma Chuanxiong 66g, Flos Carthami 68g, Rhizoma Kaempferiae 52g, Pericarpium Zanthoxyli 72g, Fructus Piperis 72g, Flos Caryophylli 36g, Fructus Piperis Longi 52g, Rhizoma Zingiberis 56g, Radix Et Rhizoma Rhei 56g is ground into coarse powder, and (pulverizing the back separately mixes, or lump together pulverizing all can), according to the percolation under fluid extract and the extractum item (appendix IO of Chinese Pharmacopoeia nineteen ninety-five version), with mass concentration is 90% alcohol dipping percolation after 24 hours, collect percolate 1100ml, medicinal residues add industrial naptha extraction 3 times again, the gasoline addition is the 420ml first time, second, be 220ml for the third time, must extract fluid, after Cortex Cinnamomi 45g pulverizes separately, with mass concentration is that 90% ethanol floods percolation after 24 hours, collect percolate 120ml, use gasoline extraction 3 times, add gasoline 45ml for the first time, second, respectively be 25ml for the third time, must extract fluid, two kinds of fluid mixes with 9: 1 volume ratio, and is standby; The above-mentioned two kinds of medicinal residues behind the extraction oil, be that 70% ethanol carries out percolation with mass concentration respectively again, collect the medicinal residues percolate 2300ml of Radix Angelicae Sinensis, Rhizoma Chuanxiong, Flos Carthami, Rhizoma Kaempferiae, Pericarpium Zanthoxyli, Fructus Piperis, Flos Caryophylli, Fructus Piperis Longi, Rhizoma Zingiberis and Radix Et Rhizoma Rhei, Cortex Cinnamomi medicinal residues percolate 260ml, merge two kinds of percolates, be evaporated to 80 ℃ and measure down that relative densities are not less than 1.20, water content is no more than 18.0% extractum, standby; After getting rubber cream 290g, Colophonium 270g, zinc oxide 360g, vaseline 30g, lanoline 70g, liquid paraffin 20g, dimethyl sulfoxide 12g, gasoline 1300ml and making substrate and remove static, add above-mentioned extractum, extraction fluid and above-mentioned Camphora, Borneolum Syntheticum and Mentholum, mix and beat evenly, be applied on the base fabric, cover and mend layer, section required activating meridians to stop pain cream.Can make the activating meridians to stop pain cream of any amount by above component and method.
The present invention also can be by Radix Angelicae Sinensis 190g, Rhizoma Chuanxiong 80g, Flos Carthami 90g, Rhizoma Kaempferiae 68g, Pericarpium Zanthoxyli 82g, Fructus Piperis 80g, Flos Caryophylli 39g, Fructus Piperis Longi 55g, Rhizoma Zingiberis 58g, Radix Et Rhizoma Rhei 58g is ground into coarse powder, and (pulverizing the back separately mixes, or lump together pulverizing all can), according to the percolation under fluid extract and the extractum item (appendix IO of Chinese Pharmacopoeia nineteen ninety-five version), with mass concentration is 90% alcohol dipping percolation after 24 hours, collect percolate 1900ml, medicinal residues add industrial naptha extraction 3 times again, the gasoline addition is the 750ml first time, second, be 350ml for the third time, must extract fluid, after Cortex Cinnamomi 45g pulverizes separately, with mass concentration is that 90% ethanol floods percolation after 24 hours, collect percolate 180ml, use gasoline extraction 3 times, add gasoline 70ml for the first time, second, respectively be 38ml for the third time, must extract fluid, two kinds of fluid mixes with 9: 1 volume ratio, and is standby; The above-mentioned two kinds of medicinal residues behind the extraction oil, be that 70% ethanol carries out percolation with mass concentration respectively again, collect the medicinal residues percolate 4300ml of Radix Angelicae Sinensis, Rhizoma Chuanxiong, Flos Carthami, Rhizoma Kaempferiae, Pericarpium Zanthoxyli, Fructus Piperis, Flos Caryophylli, Fructus Piperis Longi, Rhizoma Zingiberis and Radix Et Rhizoma Rhei, Cortex Cinnamomi medicinal residues percolate 450ml, merge two kinds of percolates, be evaporated to 80 ℃ and measure down that relative densities are not less than 1.20, water content is no more than 18.0% extractum, standby; After getting rubber cream 550g, Colophonium 520g, zinc oxide 700g, vaseline 55g, lanoline 128g, liquid paraffin 33g, dimethyl sulfoxide 18g, gasoline 2300ml and making substrate and remove static, add above-mentioned extractum, extraction fluid and above-mentioned Camphora, Borneolum Syntheticum and Mentholum, mix and beat evenly, be applied on the base fabric, cover and mend layer, section required activating meridians to stop pain cream.Can make the activating meridians to stop pain cream of any amount by above component and method.
Product of the present invention is faint yellow to amber lamellar rubber cream, gas fragrance.
By said medicine as can be known, the present invention has promoting blood circulation to remove obstruction in the collateral, dispelling cold and removing dampness, reducing swelling and alleviating pain.Be used for waist, the stagnation of knee osteoarthritis blood stasis, cold-damp resistance network disease, joint sting or dull pain, ankylosis, joint stuffiness, osseous arthritis such as aversion to cold and cold limbs.
Clinical data has fully proved above-mentioned effect of the present invention, and concrete clinical data is as follows:
One, diagnostic criteria
1, Chinese medical discrimination standard
(with reference to " new Chinese medicine clinical research guideline " " Orthopedics of Chinese Medicine ") blood stasis is stagnated, cold-damp resistance network disease
Primary symptom: (1) joint sting or localized pain; (2) joint stuffiness.
Inferior disease: (1) local fear of cold; (2) limbs are weighing; (3) pain alleviated while getting warmth or chance cold-damp increase the weight of; (4) local swelling; (5) dark tongue quality has petechia or ecchymosis; (6) Tai Bai or greasy; (7) stringy pulse is tight or slow.
Wherein primary symptom must possess, and doublely sees times three.
2, Western medicine diagnose standard
(with reference to " new Chinese medicine clinical research guideline " " clinical osteology ")
Lumbar degenerative osteoarthritis (spondylitis of lumbar hyperplasia)
(1) there is the prolonged history of being overworked for a very long period to go with person in middle and old age and sends out the age
(2) flank pain, local tenderness, limitation of activity
(3) X line performance: lumbar vertebra body lip sample hypertrophy, the articular process hypertrophy, narrowing of intervertebral space seriously can form the bone bridge, can single-shot and pilosity.
Knee osteoarthritis
(1) person in middle and old age see more
(2) play the joint in arthralgia or morning and send out deadlock or discomfort, movable back takes a turn for the better, but the stasis of blood increases the weight of bitterly during hyperkinesia, swelling, and joint motion is limited.
(3) friction sound or friction sense are arranged during joint motion, visible hydrarthrosis and episome have deformity, but do not have tetanic.
The performance of X line, osteoporosis, the magnetic nodal section is irregular, and the joint space narrows down, the sclerosis of subchondral bone matter, ridge and edge, joint hyperosteogeny between the tibia condyle, hyperosteogeny forms.
Two, select the case standard
1, includes the case standard in
All tcm diagnosis and dialectical standard and Western medicine diagnose standards of meeting can be included the test and Selection case in.
2, get rid of the case standard
(1), age under-18s or over-65s, prepare gestation or gestation or women breast-feeding their children, the allergic constitution person.
(2), be associated with serious primary disease such as cardiovascular, cerebrovascular, liver, kidney and hemopoietic system, psychotic.
(3), intercurrent disease has influence on the joint person, as psoriasis, syphilis, ochronosis, metabolic osteopathy, acute injury etc.
(4), prolapse of lumbar intervertebral disc, lumbar spinal stenosis, ankylosing spondylitis etc.
(5), rheumatic arthritis, rheumatoid arthritis.
3, rejecting standard
(1), do not meet and include standard person in.
(2), use the efficacy determination person of other medicines influence experiment medicine during the observation treatment.
(3), data is not complete, Halfway Stopping treatment (in 1 week).
Three, clinical trial therapeutic scheme
1, grouping: the grouping of table of random number method, be divided into of the present invention group and matched group at random, part adopts double-blind method to observe.
Observation group: adopt product activating meridians to stop pain cream of the present invention;
Matched group: adopt the logical card of sky and bone;
2, medication
Ointment of the present invention is affixed on the affected part, pastes 12 hours at every turn, and change dressings once every day.
The TIANHE GUTONG TIE ointment is affixed on the affected part, pastes 12 hours at every turn, and change dressings once every day.
3, double blinding observational technique
To observe medicine and contrast medicine make bony spur plaster I number, II number, specification, drug appearance color, outer packaging bag unanimity, the medication course of treatment packed into seal up for safekeeping in the pocket, be divided into I number group (the peaceful plaster of bony spur) and II number group (TIANHE GUTONG TIE) by table of random number, outside pocket, indicate serial number and random number, issue the prescription on individual diagnosis patient sequentially.
Be 2 weeks the course of treatment, respectively at 1,2,3,7,14 day, and record symptom and sign situation of change.
Four, curative effect determinate standard (with reference to the clinical research guideline of " new Chinese medicine clinical research guideline " the 3rd volume of new Chinese medicine treatment osseous arthritis)
1, clinic control: transference cure, functional activity is normal;
2, produce effects: symptom disappears substantially, and function of joint is normal substantially, can participate in normal activity and work;
3, effective: pain disappears substantially, and it is normal substantially that activity is bent and stretched in the joint, and the ability of participation activity or work has improvement;
4, invalid: as not reach effective standard.
The judgement of onset time: in observing the symptoms, the time of a certain sx or improvement promptly is decided to be the onset time after this case medication.
Five, statistical procedures
1, physical data
Select patient 420 people, wherein observe the treatment group, compare group with sky and logical obedient 120 people of bone with present inventor 300 people, all from each hospital outpatient, inpatient, natural situation is as follows:
Table 1 210 routine lumbar vertebra osseous arthritis age distribution situations
| Group | The example number | 18-30 | 31-40 | 41-50 | 51-65 | ||||
| Example | (％) | Example | (％) | Example | (％) | Example | (％) | ||
| Observation group's matched group | 150 60 | 0 0 | 16 7 | (10.67) (11.67) | 58 25 | (38.67) (41.67) | 76 28 | (50.67) (46.67) | |
Observation group's minimal ages 29 years old, maximum 64 years old age, 55.7 years old mean age, matched group minimal ages 30 years old, maximum 65 years old age, 51.3 years old mean age.
Through X 2 test, X
2=0.189, P＞0.05, statistics no significant difference.Illustrate two groups in age distribution, have comparability.
Table 2,210 routine lumbar vertebra osseous arthritis sex distribution situations
| Group | The example number | The man | The woman |
| Observation group's matched group | 150 60 | 76 29 | 74 31 |
Through X 2 test, X
2=0.008, P＞0.05, the statistics no significant difference illustrates two groups on sex distributes, and has comparability.
Table 3 210 routine lumbar vertebra osseous arthritis state of an illness distribution situations
| Group | The example number | Gently | In | Heavy | |||
| Example | (％) | Example | (％) | Example | (％) | ||
| Observation group's matched group | 150 60 | 31 14 | (20.67) (23.33) | 74 27 | (49.33) (45.00) | 45 19 | (30.00) (31.66) |
Through X 2 test, X
2=0.4389, P＞0.05, the statistics no significant difference illustrates two groups on the state of an illness distributes, and has comparability.
Table 4 210 routine lumbar vertebra osseous arthritis course of disease distribution situations
| Group | The example number | In 1 year | One to three year | More than 3 years | |||
| Example | (％) | Example | (％) | Example | (％) | ||
| Observation group's matched group | 150 60 | 56 21 | (37.33) (35.00) | 34 14 | (22.67) (23.33) | 60 25 | (40.00) (41.67) |
Through X 2 test, X
2=0.3116, P＞0.05, the statistics no significant difference illustrates two groups on the course of disease distributes, and has comparability.
Table 5 210 routine knee osteoarthritis age distribution situations
| Group | The example number | 18-30 | 31-40 | 41-50 | 51-65 | ||||
| Example | (％) | Example | (％) | Example | (％) | Example | (％) | ||
| Observation group's matched group | 150 60 | 0 0 | 18 3 | (12.00) (5) | 39 14 | (26.00) (23.33) | 93 43 | (62.00) (71.67) | |
Observation group's minimal ages 32 years old, maximum 65 years old age, 54.2 years old mean age, matched group minimal ages 36 years old, maximum 65 years old age, 55.6 years old mean age.
Through X 2 test, X
2=1.927, P＞0.05, the statistics no significant difference illustrates two groups in age distribution, has comparability.
Osseous arthritis sex distribution situation in the table 6 210 routine knee joints
| Group | The example number | The man | The woman |
| Observation group's matched group | 150 60 | 52 17 | 98 43 |
Through X 2 test, X
2=0.5225, P＞0.05, statistics no significant difference.Illustrate two groups on sex distributes, have comparability.
Table 7 210 routine knee osteoarthritis state of an illness distribution situations
| Group | The example number | Gently | In | Heavy | |||
| Example | (％) | Example | (％) | Example | (％) | ||
| Observation group's matched group | 150 60 | 49 18 | (32.67) (30) | 60 26 | (40) (43.33) | 41 16 | (27.33) (26.67) |
Through X 2 test, X
2=0.2188, P＞0.05, the statistics no significant difference illustrates two groups on the state of an illness distributes, and has comparability.
Table 8 210 routine knee osteoarthritis course of disease distribution situations
| Group | The example number | In 1 year | One to three year | More than 3 years | |||
| Example | (％) | Example | (％) | Example | (％) | ||
| Observation group's matched group | 150 60 | 62 29 | (41.33) (48.33) | 59 24 | (39.33) (40) | 29 7 | (19.33) (11.67) |
Through X 2 test, X
2=2.9116, P＞0.05, the statistics no significant difference illustrates two groups on the course of disease distributes, and has comparability.
Curative effect relatively between two groups of table 9 waist double blinding stages
| Group | The example number | Clinic control | Produce effects | Effectively | Invalid | R | ||||
| Example | (％) | Example | (％) | Example | (％) | Example | (％) | |||
| Observation group's matched group | 60 60 | 13 8 | (21.67) (13.33) | 30 16 | (50.00) (26.67) | 9 21 | (15.00) (35.00) | 8 15 | (13.33) (25.00) | 0.4367 0.5392 |
Through the Ridit check, U=2.9967, there is significant difference P＜0.05, illustrates that observation group is better than matched group on the arthropathic curative effect of treatment lumbar vertebra.
Clinical symptoms before and after the treatment of table 10 waist observation group, the sign integration improves situation
| Symptom and sign | The example number | Integration before the treatment | Treatment back integration | The difference mean |
| (x±SD) | (x±SD) | (x±SD) | ||
| Pain | 60 | 8.475±3.652 | 1.765±3.021* | 7.046±3.823 △ |
| The tenderness range of activity | 60 60 | 3.846±1.021 3.850±1.143 | 1.480±0.943* 1.247±1.064* | 2.112±0.937 ☆3.014±1.13 |
Annotate: with preceding relatively * P＜0.01 of treatment
Compare with tenderness and range of activity
ΔP＜0.05
Compare with range of activity
☆P＜0.05
Through the t check analysis, integration compares P＜0.01 before and after pain, tenderness, the range of activity treatment, illustrate that this medicine is to the effect that all has clear improvement of three symptoms, simultaneously relatively with the difference mean of pain and tenderness, range of activity, P＜0.05 illustrates that this medicine is better than tenderness and range of activity to the improvement degree of pain symptom.The difference of tenderness and range of activity compares, P＜0.05, and from clinical observation and symptom integral analysis, the improvement of range of activity is better than tenderness.
Two groups of onset times comparisons of table 11 lumbar osteoarthritis
| Group | The example number | Hour (x ± SD) | t | P |
| Observation group's matched group | 60 60 | 41.654±21.522 60.873±23.347 | 4.688 | ＜0.05 |
Through t check, t=4.688, P＜0.05 illustrates that observation group onset time is rapid-action than matched group.
2, the efficacy analysis of knee osteoarthritis
Curative effect relatively between two groups of table 12 knee double blinding stages
| Group | The example number | Clinic control | Produce effects | Effectively | Invalid | R | ||||
| Example (%) | Example (%) | Example (%) | Example (%) | |||||||
| Observation group | 60 | 14 | (23.33) | 20 | (33.33) | 18 | (30) | 8 | (13.33) | 0.4194 |
| Matched group | 60 | 5 | (8.33) | 12 | (20) | 27 | (45) | 16 | (26.67) | 0.5805 |
Through the Ridit check, U=3.056, there is significant difference P＜0.05, illustrates that observation group is better than matched group on the curative effect of treatment knee osteoarthritis.
Clinical symptoms, sign integration improve situation before and after the treatment of table 13 knee observation group
| Symptom and sign | The example number | Integration before the treatment | Treatment back integration | The difference mean |
| (x±SD) | (x±SD) | (x±SD) | ||
| The spontaneous pain pain tenderness range of activity of having squatted | 60 60 60 60 | 8.121±5.247 4.159±1.935 3.275±1.987 3.370±1.933 | 3.233±4.047* 1.968±2.014* 1.531±1.811* 1.355±1.767* | 5.141±3.47 △ 2.060±1.43 1.894±1.77 1.738±1.311 |
Annotate: with preceding relatively * P＜0.05 of treatment
Compare Δ P＜0.05 with the pain of having squatted, tenderness, range of activity
Through the t check analysis, integration compares P＜0.05 before and after spontaneous pain, the pain of having squatted, tenderness, the range of activity treatment, point out this medicine that four symptoms are all had the improvement effect, simultaneously with difference mean comparison P＜0.05 of spontaneous pain, illustrate that this medicine is to the improvement degree of spontaneous pain symptom be better than having squatted pain, tenderness, range of activity with has squatted pain, tenderness, range of activity.
Whole observation groups of table 14 and matched group curative effect are relatively
| Group | The example number | Clinic control | Produce effects | Effectively | Invalid | R | ||||
| Example | (％) | Example | (％) | Example | (％) | Example | (％) | |||
| Observation group's matched group | 300 120 | 74 14 | (24.67) (11.67) | 123 27 | (41) (22.5) | 61 48 | (20.33) (40) | 42 31 | (14) (25.83) | 0.4543 0.6139 |
Through the Ridit check, U=5.1318, there is significant difference P＜0.05, illustrates that curative effect compares between two groups, and observation group is better than matched group.
Table 15 is observation group's course of disease and therapeutic effect relationship all
| The course of disease | The example number | Clinic control | Produce effects | Effectively | Invalid | R | ||||
| Example | (％) | Example | (％) | Example | (％) | Example | (％) | |||
| 1 year with interior one to three year more than 3 years | 118 94 88 | 41 15 18 | (34.74) (15.96) (20.45) | 45 44 34 | (38.14) (46.81) (38.64) | 24 23 14 | (20.34) (24.47) (15.91) | 8 12 22 | (6.78) (12.76) (25) | 0.4323 0.5353 0.5528 |
Through Ridit check, X
2=10.4499, P＜0.05 illustrates that the course of disease is relevant with curative effect, and the short more curative effect of the course of disease is good more.
The table 16 observation group state of an illness and therapeutic effect relationship
| The state of an illness | The example number | Clinic control | Produce effects | Effectively | Invalid | R | ||||
| Example | (％) | Example | (％) | Example | (％) | Example | (％) | |||
| Heavy in light | 82 132 86 | 30 34 10 | (36.59) (25.76) (11.63) | 36 57 30 | (43.9) (43.18) (34.88) | 14 21 26 | (17.07) (15.91) (30.23) | 2 20 20 | (2.44) (15.15) (23.26) | 0.3955 0.4883 0.6174 |
Through Ridit check, X
2=25.1863, P＜0.05 illustrates that the state of an illness is relevant with curative effect, and the light more curative effect of the state of an illness is good more.
Table 17 is observation group's age and therapeutic effect relationship all
| Age (year) | The example number | Clinic control | Produce effects | Effectively | Invalid | R | ||||
| Example | (％) | Example | (％) | Example | (％) | Example | (％) | |||
| 18-30 31-40 41-50 51-65 | 0 36 98 166 | 0 15 28 30 | (41.67) (28.57) (18.07) | 0 16 37 71 | (44.44) (37.76) (42.77) | 0 3 19 39 | (8.33) (19.39) (23.49) | 0 2 14 26 | (5.56) (14.28) (15.66) | 0.3655 0.4845 0.5382 |
Through Ridit check, X
2=11.0032, P＜0.05 illustrates that the age is relevant with curative effect, and more little curative effect of age is good more.
Table 18 constituent parts observation group and matched group curative effect are relatively
| Unit | Group adds | The example number | Clinic control | Produce effects | Effectively | Invalid | ||||
| Example (%) | Example (%) | Example (%) | Example (%) | |||||||
| Liaoning traditional Chinese medical science | Observation group | 90 | 19 | (21.11) | 45 | (50) | 11 | (12.22) | 15 | (16.67) |
| Matched group | 30 | 5 | (16.67) | 9 | (27) | 9 | (27) | 7 | (23.33) | |
| Dongzhimen hospital | Observation group | 60 | 15 | (25) | 20 | (33.33) | 17 | (28.33) | 8 | (13.33) |
| Matched group | 30 | 3 | (10) | 6 | (20) | 13 | (43.33) | 8 | (26.67) | |
| Bone grinds institute | Observation group | 90 | 25 | (27.78) | 36 | (40) | 17 | (18.89) | 12 | (13.33) |
| Matched group | 30 | 4 | (13.33) | 6 | (20) | 12 | (40) | 8 | (26.67) | |
| The Henan traditional Chinese medical science | Observation group | 60 | 15 | (25) | 22 | (36.67) | 16 | (26.66) | 7 | (11.67) |
| Matched group | 30 | 2 | (6.67) | 6 | (20) | 14 | (46.67) | 8 | (26.66) | |
Through Ridit check, observation group and matched group comparison between each observation unit, P＞0.05 illustrates the observed result indifference of constituent parts, efficacy stability of the present invention is reliable.
Table 19 observation group security inspection
| The example number | Routine blood test | Routine urinalysis | Just conventional | Liver function | The kidney merit | Electrocardiogram | |||||||
| Normally | Undesired | Normally | Undesired | Normally | Undesired | Normally | Undesired | Normally | Undesired | Normally | Undesired | ||
| After treating before the treatment | 120 120 | 119 120 | 1 0 | 120 120 | 0 0 | 120 120 | 0 0 | 113 113 | 7 7 | 118 119 | 2 1 | 117 117 | 3 3 |
Safety is observed in the case, and the preceding WBC of 1 example treatment increases, and observation finishes the back and recovers normally, and TBIL, GGT, ALT increase before the 7 routine treatments, still increases after the treatment, but does not trip out the preceding numerical value of treatment, and Bcr increases before the 2 routine treatments, and 1 is routine normal after the treatment, 1 routine no change; 1 routine old myocardial infarction, 1 routine bradycardia, 1 routine myocardial ischemia, no change before and after the treatment.
Six, conclusion
1, to therapeutic evaluation
Activating meridians to stop pain cream of the present invention (the peaceful plaster of bony spur) treatment osseous arthritis (blood stasis is stagnated, cold dampness accumulation pattern rheumatism involving the bone disease) has good and clinical curative effect.The total obvious effective rate 73.33% of waist double blinding stage observation group, total effective rate 86.67%, waist double blinding stage matched group always show friendship rate 40%, total effective rate 75%; The curative effect statistical analysis of observation group and matched group has significant difference (P＜0.05); The total obvious effective rate 56.67% of knee double blinding stage observation group, total effective rate 86.67%, the total obvious effective rate 28.33% of knee double blinding stage matched group, total effective rate 73.33%, observation group and matched group curative effect statistical analysis have significant difference (P＜0.05); The total obvious effective rate 68.89% of waist open phase observation group always has friendship rate 85.56%; The total obvious effective rate 63.33% of knee open phase observation group, total effective rate 77.78%; The total obvious effective rate 65.67% of whole observation groups, total effective rate 86%, whole total obvious effective rates 34.17% of matched group, total effective rate 74.17%.Statistical result shows, waist and knee joint double blinding stage observation group curative effect are better than matched group, all the overall curative effect of observation group is better than the overall curative effect of whole matched groups, and promptly the curative effect of the peaceful plaster of bony spur is better than the curative effect of TIANHE GUTONG TIE, and plaster of the present invention is a kind of active drug for the treatment of osseous arthritis.
2, the cardinal symptom sign is improved situation
From statistical analysis (P＜0.05) to symptom and sign integration situation of change before and after waist, the treatment of knee observation group, illustrate that plaster of the present invention all has curative effect preferably to the sings and symptoms that waist, kneecap arthrosis are occurred, and the curative effect to the spontaneous pain symptom of the pain of waist and knee is better than other symptom, illustrates that plaster of the present invention has better pain relieving effect.
3, tcm symptom improves situation
To the clinical effectiveness of tcm symptom, through clinical observation, it improves obviously the pain related symptoms, and as local twinge or localized pain, the joint stuffiness effect is better.
4, onset time
The onset time of observation group and the onset time of matched group, relatively (P＜0.05) was analysed in credit by statistics, and the onset time that observation group is described, plaster promptly of the present invention was fast than TIANHE GUTONG TIE to the improvement of symptom faster than contrast.
5, correlation analysis
Plaster of the present invention treatment osseous arthritis (blood stasis is stagnated, cold dampness accumulation pattern rheumatism involving the bone disease), short to the course of disease, that the state of an illness is light, the age is little patient's curative effect are better than that the course of disease is long, the state of an illness is heavy, older patient's curative effect.
6, toxic and side effects and untoward reaction
During safety is observed, toxic and side effects to the heart, liver, renal function does not take place, but 10 examples are arranged in observing case at treatment later stage skin pruritus, flushing, a little erythema is arranged, after removing plaster, skin pruritus, flushing, erythema all disappear in 12 hours, do not influence to continue treatment, may be to cause due to the breathability difference owing to being warm, pasting rubber plaster.
Characteristics such as in a word, prove by clinical observation that activating meridians to stop pain cream of the present invention is applicable to waist, knee osteoarthritis patient, curative effect is better than TIANHE GUTONG TIE, is the ideal medicament of treatment waist, knee osteoarthritis, and be advisable with two weeks the course of treatment, easy to use, safe.Value for clinical application is arranged, and its develop and spread must bring happiness for the patient, for Chinese medicine and pharmacy is made creative contribution.
Claims (6)
1, a kind of activating meridians to stop pain cream, it is characterized in that, be to be made by following Chinese medicine: Radix Angelicae Sinensis 105-200g, Rhizoma Chuanxiong 65-85g, Flos Carthami 65-100g, Rhizoma Kaempferiae 50-60g, Pericarpium Zanthoxyli 70-85g, Fructus Piperis 70-85g, Flos Caryophylli 35-40g, Cortex Cinnamomi 40-60g, Fructus Piperis Longi 50-60g, Rhizoma Zingiberis 55-60g, Radix Et Rhizoma Rhei 55-60g, Camphora 45-60g, Borneolum Syntheticum 30-40g, Mentholum 30-40g.
2, a kind of activating meridians to stop pain cream according to claim 1, it is characterized in that, be to be made by following Chinese medicine: Radix Angelicae Sinensis 110g, Rhizoma Chuanxiong 66g, Flos Carthami 68g, Rhizoma Kaempferiae 52g, Pericarpium Zanthoxyli 72g, Fructus Piperis 72g, Flos Caryophylli 36g, Cortex Cinnamomi 45g, Fructus Piperis Longi 52g, Rhizoma Zingiberis 56g, Radix Et Rhizoma Rhei 56g, Camphora 46g, Borneolum Syntheticum 31g, Mentholum 31g.
3, a kind of activating meridians to stop pain cream according to claim 1, it is characterized in that, be to be made by following Chinese medicine: Radix Angelicae Sinensis 190g, Rhizoma Chuanxiong 80g, Flos Carthami 90g, Rhizoma Kaempferiae 68g, Pericarpium Zanthoxyli 82g, Fructus Piperis 80g, Flos Caryophylli 39g, Cortex Cinnamomi 55g, Fructus Piperis Longi 55g, Rhizoma Zingiberis 58g, Radix Et Rhizoma Rhei 58g, Camphora 55g, Borneolum Syntheticum 38g, Mentholum 38g.
4, the production method of a kind of activating meridians to stop pain cream according to claim 1, its spy is characterised in that, earlier Radix Angelicae Sinensis 105-200g, Rhizoma Chuanxiong 65-85g, Flos Carthami 65-100g, Rhizoma Kaempferiae 50-60g, Pericarpium Zanthoxyli 70-85g, Rhizoma Zingiberis 55-60g, Fructus Piperis 70-85g, Flos Caryophylli 35-40g, Radix Et Rhizoma Rhei 55-60g, Fructus Piperis Longi 50-60g is ground into coarse powder, according to the percolation under fluid extract and the extractum item, with mass concentration is 90% alcohol dipping percolation after 24 hours, collect percolate 1000-2000ml, medicinal residues add industrial naptha extraction 3 times again, the gasoline addition is the 400-800ml first time, second, be 200-400ml for the third time, must extract fluid, after Cortex Cinnamomi 40-60g pulverizes separately, be that 90% ethanol floods percolation after 24 hours, collection percolate 100-200ml with mass concentration, with gasoline extraction 3 times, add for the first time gasoline 40-80ml, second, respectively be 20-40ml for the third time, must extract fluid, two kinds of fluid mixes with 9: 1 volume ratio, and is standby; The above-mentioned two kinds of medicinal residues behind the extraction oil, be that 70% ethanol carries out percolation with mass concentration respectively again, collect the medicinal residues percolate 2250-4500ml of Radix Angelicae Sinensis, Rhizoma Chuanxiong, Flos Carthami, Rhizoma Kaempferiae, Pericarpium Zanthoxyli, Fructus Piperis, Flos Caryophylli, Fructus Piperis Longi, Rhizoma Zingiberis and Radix Et Rhizoma Rhei, Cortex Cinnamomi medicinal residues percolate 250-500ml, merge two kinds of percolates, be evaporated to 80 ℃ and measure down that relative densities are not less than 1.20, water content is no more than 18.0% extractum, standby; Get rubber cream 285-570g, Colophonium 268-536g, zinc oxide 355-710g, all go up woods 29-58g, lanoline 68-136g, liquid paraffin 18-36g, dimethyl sulfoxide 10-20g, gasoline 1200-2400ml and make substrate and remove static after, add above-mentioned extractum, extraction fluid and above-mentioned Camphora, Borneolum Syntheticum and Mentholum, mix and beat evenly, be applied on the base fabric, cover and mend layer, section.
5, the production method of a kind of activating meridians to stop pain cream according to claim 4, its spy is characterised in that, earlier Radix Angelicae Sinensis 110g, Rhizoma Chuanxiong 66g, Flos Carthami 68g, Rhizoma Kaempferiae 52g, Pericarpium Zanthoxyli 72g, Fructus Piperis 72g, Flos Caryophylli 36g, Fructus Piperis Longi 52g, Rhizoma Zingiberis 56g, Radix Et Rhizoma Rhei 56g is ground into coarse powder, according to the percolation under fluid extract and the extractum item, with mass concentration is 90% alcohol dipping percolation after 24 hours, collect percolate 1100ml, medicinal residues add industrial naptha extraction 3 times again, the gasoline addition is the 420ml first time, second, be 220ml for the third time, must extract fluid, after Cortex Cinnamomi 45g pulverizes separately, be that 90% ethanol floods percolation after 24 hours, collection percolate 120ml with mass concentration, with gasoline extraction 3 times, add for the first time gasoline 45ml, second, respectively be 25ml for the third time, must extract fluid, two kinds of fluid mixes with 9: 1 volume ratio, and is standby; The above-mentioned two kinds of medicinal residues behind the extraction oil, be that 70% ethanol carries out percolation with mass concentration respectively again, collect the medicinal residues percolate 2300ml of Radix Angelicae Sinensis, Rhizoma Chuanxiong, Flos Carthami, Rhizoma Kaempferiae, Pericarpium Zanthoxyli, Fructus Piperis, Flos Caryophylli, Fructus Piperis Longi, Rhizoma Zingiberis and Radix Et Rhizoma Rhei, Cortex Cinnamomi medicinal residues percolate 260ml, merge two kinds of percolates, be evaporated to 80 ℃ and measure down that relative densities are not less than 1.20, water content is no more than 18.0% extractum, standby; After getting rubber cream 290g, Colophonium 270g, zinc oxide 360g, vaseline 30g, lanoline 70g, liquid paraffin 20g, dimethyl sulfoxide 12g, gasoline 1300ml and making substrate and remove static, add above-mentioned extractum, extraction fluid and above-mentioned Camphora, Borneolum Syntheticum and Mentholum, mix and beat evenly, be applied on the base fabric, cover and mend layer, section.
6, the production method of a kind of activating meridians to stop pain cream according to claim 4, its spy is characterised in that, Radix Angelicae Sinensis 190g, Rhizoma Chuanxiong 80g, Flos Carthami 90g, Rhizoma Kaempferiae 68g, Pericarpium Zanthoxyli 82g, Fructus Piperis 80g, Flos Caryophylli 39g, Fructus Piperis Longi 55g, Rhizoma Zingiberis 58g, Radix Et Rhizoma Rhei 58g is ground into coarse powder, according to the percolation under fluid extract and the extractum item, with mass concentration is 90% alcohol dipping percolation after 24 hours, collect percolate 1900ml, medicinal residues add industrial naptha extraction 3 times again, the gasoline addition is the 750ml first time, second, be 350ml for the third time, must extract fluid, after Cortex Cinnamomi 45g pulverizes separately, be that 90% ethanol floods percolation after 24 hours, collection percolate 180ml with mass concentration, with gasoline extraction 3 times, add for the first time gasoline 70ml, second, respectively be 38ml for the third time, must extract fluid, two kinds of fluid mixes with 9: 1 volume ratio, and is standby; The above-mentioned two kinds of medicinal residues behind the extraction oil, be that 70% ethanol carries out percolation with mass concentration respectively again, collect the medicinal residues percolate 4300ml of Radix Angelicae Sinensis, Rhizoma Chuanxiong, Flos Carthami, Rhizoma Kaempferiae, Pericarpium Zanthoxyli, Fructus Piperis, Flos Caryophylli, Fructus Piperis Longi, Rhizoma Zingiberis and Radix Et Rhizoma Rhei, Cortex Cinnamomi medicinal residues percolate 450ml, merge two kinds of percolates, be evaporated to 80 ℃ and measure down that relative densities are not less than 1.20, water content is no more than 18.0% extractum, standby; After getting rubber cream 550g, Colophonium 520g, zinc oxide 700g, vaseline 55g, lanoline 128g, liquid paraffin 33g, dimethyl sulfoxide 18g, gasoline 2300ml and making substrate and remove static, add above-mentioned extractum, extraction fluid and above-mentioned Camphora, Borneolum Syntheticum and Mentholum, mix and beat evenly, be applied on the base fabric, cover and mend layer, section.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102049028A (en) * | 2010-11-17 | 2011-05-11 | 河南羚锐制药股份有限公司北京药物研究院 | Method for establishing HPLC (high performance liquid chromatography) fingerprint graphic for ointment for unblocking collaterals and relieving pain as well as standard fingerprint graphic thereof |
| CN104623601A (en) * | 2015-02-04 | 2015-05-20 | 北京全净通一科技有限公司 | Pain relieving oil agent for external use and preparation method of pain relieving oil agent |
| CN105534960A (en) * | 2016-03-02 | 2016-05-04 | 四川省富膏奇健康管理有限公司 | Collateral-dredging plaster production technology |
| CN105943238A (en) * | 2016-06-15 | 2016-09-21 | 马南行 | Hot compress sticker for improving microcirculation and preparation method thereof |
| CN109364235A (en) * | 2018-12-29 | 2019-02-22 | 日照市中医医院 | A kind of emplastrum and preparation method thereof for treating gynaecology's post-abortion discomfort |
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2006
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102049028A (en) * | 2010-11-17 | 2011-05-11 | 河南羚锐制药股份有限公司北京药物研究院 | Method for establishing HPLC (high performance liquid chromatography) fingerprint graphic for ointment for unblocking collaterals and relieving pain as well as standard fingerprint graphic thereof |
| CN102049028B (en) * | 2010-11-17 | 2012-10-24 | 河南羚锐制药股份有限公司北京药物研究院 | Method for establishing HPLC (high performance liquid chromatography) fingerprint graphic for ointment for unblocking collaterals and relieving pain as well as standard fingerprint graphic thereof |
| CN104623601A (en) * | 2015-02-04 | 2015-05-20 | 北京全净通一科技有限公司 | Pain relieving oil agent for external use and preparation method of pain relieving oil agent |
| CN104623601B (en) * | 2015-02-04 | 2018-02-13 | 北京全净通一科技有限公司 | A kind of exterior-applied antalgic finish and preparation method |
| CN105534960A (en) * | 2016-03-02 | 2016-05-04 | 四川省富膏奇健康管理有限公司 | Collateral-dredging plaster production technology |
| CN105943238A (en) * | 2016-06-15 | 2016-09-21 | 马南行 | Hot compress sticker for improving microcirculation and preparation method thereof |
| CN109364235A (en) * | 2018-12-29 | 2019-02-22 | 日照市中医医院 | A kind of emplastrum and preparation method thereof for treating gynaecology's post-abortion discomfort |
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