CN100348239C - Chinese traditional medicine for curing soft tissue pains and process for preparing the same - Google Patents

Abstract

The present invention discloses a medicine for treating parenchyma pain, and a preparation method for the medicine. The medicine is prepared with components of giraldi daphne liquid extract, borneol, camphor, methyl salicylate, rue liquid extract, belladonna liquid extract and menthol which are selected and combined to enable respective component effects to generate synergism according to Chinese medicine clinical experience combining modern pharmacological research by professor Dongke Zhao. The medicine has the functions of blood circulation promotion for relieving pain, meridian warming for expelling cold, muscle and tendon relaxation, vital energy regulation, dampness elimination, meridian activation, detumescence, analgesia, meridian activation, wind elimination, muscle and tendon relaxation, tendon and bone strengthening, blood stasis removal, elimination, tendon relaxation, blood stasis activation, meridian passage dredging, striae of skin, muscle and viscus warming and activation, and healthy energy strengthening for eliminating pathogens. A large number of clinical tests and pharmacodynamics research show that the present invention has a good therapeutic effect on parenchyma pain, and a total effective rate is 94.03%. The present invention has the advantages of fast effect, long term duration, small side effect, low toxicity, strong adhesive capacity, slight stripping reaction, few allergic reactions, reasonable manufacturing technique, easy popularization, no pain or trauma, convenient use, organic solvent saving and low manufacturing cost.

Description

A kind of Chinese medicine preparation and preparation method for the treatment of soft tissue pain

Technical field

The invention discloses a kind of medicine and preparation method for the treatment of soft tissue pain, is the Chinese medicine preparation of feedstock production with Chinese medicine specifically, belongs to the field of Chinese medicines.

Background technology

Soft tissue pain comprises that cervical spondylosis, scapulohumeral periarthritis, tennis elbow, lumbar muscle strain, acute and chronic soft tissue injury, muscle sprain, lumbar spinal stenosis, rheumatic arthritis, rheumatoid arthritis, sciatica, gout and rheumatism cause each myalgia of whole body, show as position pain such as joint, muscle, muscles and bones, swelling, morning deadlock, numbness, joint stuffiness mostly, joint swelling deformation very then, tetanicly do not stretch amyotrophy.Its disease sites pain, inconvenient activity has a strong impact on work and daily life, and especially at cold district, this sick sickness rate is higher.Soft tissue pain is equivalent to the arthromyodynia in the Chinese medicine, is the invasion and attack of human body wind-engaging, cold, wet three heresies, makes QI-blood circulation not smooth, the meridians that flow away, and space between skin and muscles is empty, and Wei Yang is not solid, so that disharmony between QI and blood, inaccessible obstructed forming; Or in intrinsic heat is arranged, be subjected to the rheumatic fever heresy outward, the visitor is in meridians so that coagulation of QI-blood forms; Or the heresy of cold-damp attacks to the marrow deeply, numbness resistance meridians, and the multiple abscess joint, vim and vigour are not all right, and the joint is closed puckery, muscles and bones lose to be supported, and gradually causes clonic spasm of the muscle bone pine, and joint deformity must not be bent and stretched, even the volume meat muscle that contracts, the muscles and bones person, can cause heresy and go into Liver and kidney, the clonic spasm of the muscle osteodynia, arthrogryposis can not be walked; Or hold concurrently because of the diseases caused by exogenous pathogenic factor ailment said due to cold or exposure, the invasion and attack meridians, outbreak repeatedly makes blood stasis stagnate then, and the network road blocks, and it is stiff to cause joint deformity at last, limitation of activity.

Pain is the main clinical manifestation of soft tissue injury, is sensation and experience that a lot of people had, is a kind of physiology defense mechanism of being finished by nociceptor, conduction nerve and pain maincenter fellowship.The perception of pain and response activity almost relate to whole brain, comprise thalamus, hypothalamus, reticular formation of brain stem, positions such as limbic system, cerebral cortex.From clinical pain following characteristics are arranged: 1. pain is because body is inside and outside than a kind of clinical symptoms that strong stimulation produced; 2. pain is the subjective sensation and the sign of body, includes the factor of psychological each side such as physiology and spiritual emotion experience; 3. the physiological reaction of pain comprises pain perception and pain reaction, and pain reaction can be partial or systemic reaction, and everyone is under the different physiology and mental activity state of different environment, body, and its impression is different with reaction; 4. the physiologic meaning of pain is that body passes through the pain feel to pain to a certain degree and pain is reacted, and makes body make the adaptability defense reaction rapidly, has protective effect.But cross strong pain and can cause certain infringement, can not rely on pain whether to occur judging that body has or not injury and disease simultaneously merely to body; 5. because each body is very big to the impression and the reaction individual variation of pain, therefore increased the complexity of clinical treatment.

Doctor trained in Western medicine does not have specificity to soft tissue pain, so far both at home and abroad when treatment soft tissue pain, treatments such as main application corticosteroid hormone and analgesic, as the antiinflammatory in the opioid analgesics, febricide etc., as indometacin, Phenylbutazone, aspirin and compound preparation thereof etc., though can reach the effect of controlling symptoms, because toxic and side effects is big, treatment cycle is long, makes the patient fear and is difficult to accept.Opium class medicine pain relieving meetings such as life-time service morphine make the patient produce drug dependence, and curative effect is also had a greatly reduced quality.On April 7th, 2005, U.S. food Drug Administration (FDA) issues the up-to-date medication guide of all anti-inflammation analgesics, has delivered statement with regard to how using anti-inflammation analgesic.Statement points out that all non-steroid antiinflammatory drugs all have potential cardiovascular and digestive tract hemorrhage untoward reaction risk.This lists 21 kinds of anti-inflammation analgesics, comprising the people ibuprofen, diclofenac, indometacin, celecoxib etc. of normal use.FDA has required these pharmaceutical production producers to add the black surround caution in its description.Cardiovascular risk is the problem that comprises all anti-inflammation analgesics of cox 2 inhibitor.After the medical treatment failure, operation is as last a kind of method that solves disease, and under severe malnutrition and weak situation, surgical effect is also undesirable in the patient many places, and the expense height, and is painful big, narrow application range, and postoperative may be left over sequela.Though the medicine of Chinese traditional treatment soft tissue pain is a lot, only the patent of invention of China's application just reach 120 surplus, as: application number be, 93100570.1, name is called: the quick-acting analgesic tincture of treatment constitutional soft tissue ache; Application number is 99117404.6, and name is called: a kind of medicine for external use for the treatment of soft tissue pain; Application number is 02153423.3, and name is called: a kind of Chinese medicine preparation for the treatment of soft tissue pain; Application number is 02822262.8, the name be called: be used for the treatment of the chemical compound of sub-dermal soft tissue pain, but or do not have compellent clinical data and model case, curative effect makes us doubting, or lacking pharmacodynamic experiment data and safety research, toxicity is unknown.Traditional therapy is also nothing more than attacking the pathogens first and then tonifying or tonifying first and then eliminating the pathogen, pain relieving by force, and symptomatic treatment in acute condition, rules such as relieving the primary symptom in a chronic case are difficult to tackle the problem at its root.

Summary of the invention

Purpose of the present invention is exactly the problem that exists at above-mentioned prior art, need not perform the operation and provide a kind of, have safe, quick-acting, not trace, do not recur, no sequel, advantage such as economical and practical, be applicable to the treatment of various soft tissue pain, and the high Chinese medicine preparation of cure rate.

The present invention passes through percutaneous drug delivery, have stronger antiinflammatory, detumescence, analgesia, damp eliminating effect, be used for the treatment of the various pain that scapulohumeral periarthritis, cervical spondylosis, lumbar muscle strain cause, than oral (stimulating gastrointestinal road, vomiting causes nausea), (curative effect is low and produce effects is slow for injection, acupuncture point block method (local redness and pain) and black plaster, and pollution clothes) more constant blood drug level is arranged, curative effect height and side reaction is few, duration of efficacy is long and clean, is a kind of comparatively ideal route of administration.

This preparation be the pharmacologist professor ZhaoDongKe based on motherland's medical science to the pathogenetic understanding of soft tissue pain, theory of Chinese medical science thinks, soft tissue pain mainly is that battalion defends deficiency, negative and positive of qi and blood imbalance, or deficiency of both the liver and kidney, weakened body resistance and evil gathering, feel exopathogen again, or double congestion and giving birth to.Excavate the traditional Chinese medical science and enrich clinical experience, in conjunction with modern pharmacological research, test drawing in a large number, each amounts of components all has better curative effect in the following weight parts scope.

Daphne giraldii Nitsche fluid extract 10-20 part, Borneolum Syntheticum 2-6 part, Camphora 5-12 part, methyl salicylate 3-9 part, liguidamber resinoid 2-10 part, Semen daturae fluid extract 6-18 part, Mentholum 2-6 part.

Be preferably: 15 parts of Daphne giraldii Nitsche fluid extracts, 4 parts of Borneolum Syntheticums, 8 parts of Camphoras, 6 parts of methyl salicylate, 5 parts of liguidamber resinoids, 12 parts of Semen daturae fluid extracts, 4 parts of Mentholums.

Daphne giraldii Nitsche feeble QI wherein, mildly bitter flavor.Wind-damp dispelling, promoting blood circulation and stopping pain.Be used for rheumatic arthralgia, arthritis, rheumatoid arthritis.Borneolum Syntheticum suffering, hardship are slightly cold.GUIXIN, spleen, lung meridian.The refreshment of having one's ideas straightened out, clearing away heat to alleviate pain.Camphora dehumidifying parasite killing, warming and odynolysis has one's ideas straightened out that it is dirty to ward off, the analgesia wind dispelling.Methyl salicylate (wintergreen oil) has local irritant effect, can promote local blood circulation, detumescence, and antiinflammatory and analgesia also have antipruritic effect.But Folium Symplocoris Caudatae allaying tiredness.The Semen daturae tincture mildly bitter flavor.Main component is a hyoscyamine, and contains scopolamine, atropina and apoatropine etc., and analgesic activity is arranged.The Mentholum external can antiinflammatory, pain relieving, and antipruritic, blood circulation promoting alleviates edema etc.

Daphne giraldii Nitsche fluid extract, Borneolum Syntheticum, Camphora, methyl salicylate, the casual cream of Folium Symplocoris Caudatae, Semen daturae fluid extract, Mentholum share, and have promoting blood circulation and stopping pain, and warming the meridian is cold to loose the refreshment of having one's ideas straightened out, Shujin is regulated the flow of vital energy, antiinflammatory blood stasis dispelling, treatment of arthritis and promoting collateral and channels, Repercusion analgesia, dissipating blood stasis dries, suppressing the hyperactive liver to relieve the wind syndrome, active dispeling the wind, the blood stasis dispelling of promoting blood circulation, continuous muscle wind dispelling, the circulation of qi promoting of calming the nerves, relaxation and stretching, bone and muscle strengthening, change saprophytic newly, blood stasis removing and clots absorbing is stretched the muscle stasis of blood of living, and easypro network stimulates the menstrual flow, heat clearing away is warded off dirty, invigorating striae of the skin, the effect of strengthening vital QI to eliminate pathogenic factors.Attack benefit synchronously, amount GSMC is big, gets to imitate the speed victory.

We's pharmacology has synergism mutually, the easing pain and diminishing inflammation and the antibacterial action of Daphne giraldii Nitsche have been strengthened, particularly the casual cream of Semen daturae stream has pain relieving and suppresses glandular integumentaria system secretory action, reduce body and get rid of by body surface night, prevent and the existing reduction capillary fragility of formation, Folium Symplocoris Caudatae fluid extract of vesicle when reducing plaster, increase capillary resistance, prevent dermatorrhagia, reduced the skin erythema erythra and formed, the no Moschus of we does not have excitation to gravid uterus, so the anemia of pregnant woman needn't avoid.

Modern pharmacological research shows that the present invention has cholinolytic behind the joint of blocking-up M type cholinoceptor, remove muscular spasm, excessive flesh activity or muscular spasm had relexation, prevent that inflammatory from invading profit, infection and improve the not effect of tip blood circulation and capillary permeability, can optionally stimulate the Cold receptor of human body skin or mucosa, produce sense of cold reflection and creeping chill, cause skin mucosa vasoconstriction (in fact skin keep normal), also can cause the blood vessel of deep tissue and shrink and produce therapeutical effect.Thereby can antiinflammatory, detumescence, pain relieving, analgesia, wind dispelling, blood circulation promoting alleviates edema etc., and can suppress arthroncus and form and eliminate arthroncus, is beneficial to the reparation of damaged tissue, thereby reaches the purpose of treatment soft tissue pain.

Medicine of the present invention has the following advantages:

1. each component of medicine of the present invention all meets Pharmacopoeia of the People's Republic of China regulation, utilizes the comprehensive function of the medicine of respectively distinguishing the flavor of, and can implement effectively treatment, short treating period, cure rate height to various soft tissue pain.

2. painless noinvasive, easy to use, comfortable, safety.

3. the medicine of respectively distinguishing the flavor of source is easy to get, and is easy to promote.

4. production technology is simple, and is cheap.

5. Product transport is easy to carry, is easy to deposit storage.

Another aspect of the present invention relates to a kind of prescription for the treatment of soft tissue pain's paste substrate.

Each substrates quantity all has better effects in the following weight parts scope.

Rubber 20-40 part, zinc oxide 30-50 part, Colophonium 20-40 part, lanoline 5-12 part, vaseline 2-5 part, liquid paraffin 1-3 part.

Each substrates quantity is preferably:

32 parts of rubber, 40 parts of zinc oxide, 32 parts of Colophonium, 8 parts of lanolines, 3 parts in vaseline, 2 parts of liquid paraffin.

Another aspect of the present invention relates to a kind of preparation method for the treatment of soft tissue pain's unguentum.

Get the Daphne giraldii Nitsche fluid extract, add Borneolum Syntheticum, Camphora, methyl salicylate, liguidamber resinoid, Semen daturae fluid extract, Mentholum, mixing adds the substrate of being made by rubber, zinc oxide, Colophonium, lanoline, vaseline, liquid paraffin again, make coating, be coated with cream, cutting, the lid lining, section, promptly.This composition of medicine also can be made tincture, cream, spray, Emulsion.

The present invention is by the local skin drug of topical application, and as administration channel, people's skin surface is long-pending wide also to be simultaneously the most a kind of tissue of easy arrival of medicine with skin, and the surface area of adult skin is about 20.000cm ², 1/3 sensible skin is arranged in circulation blood.Think in the past that the medicine that skin is used is before entering blood circulation, play pharmacodynamics effect at local skin, present known dermatologic can be used as the route of administration of many systemic effect medicines.

The present invention is by different skin histology layers, particularly can transdermal material layer can be dermopapillary blood capillary absorbs, in percutaneous process, the molecule of its effective ingredient runs into the diffusional resistance of different skin layer, the composition that absorbs in interlaced plies often can keep a couple of days, until being come off by its metabolic process by horn cell.

The present invention is described in further detail below in conjunction with instantiation that the inventor provides.

The specific embodiment

Embodiment 1

Take by weighing each raw material according to following weight parts

10 parts of Daphne giraldii Nitsche fluid extracts, 2 parts of Borneolum Syntheticums, 5 parts of Camphoras, 3 parts of methyl salicylate, 2 parts of liguidamber resinoids, 6 parts of Semen daturae fluid extracts, 2 parts of Mentholums.

Manufacture method: get 10 parts of Daphne giraldii Nitsche fluid extracts, add 2 parts of Borneolum Syntheticums, 5 parts of Camphoras, 3 parts of methyl salicylate, 2 parts of liguidamber resinoids, 6 parts of Semen daturae fluid extracts, 2 parts of mixings of Mentholum, add again by 20 parts of rubber, 30 parts of zinc oxide, 20 parts of Colophonium, 5 parts of lanolines, 2 parts in vaseline, 1 part of substrate of making of liquid paraffin, make coating, be coated with cream, cutting, the lid lining, section, specification: every 5cm * 7cm, packing: complex pocket, 5cm * 7cm * 5 are pasted * 1 bag.

[usage and dosage] external is pasted for one time 1, changed once in 24～48 hours, with illing skin clean dry after, plaster is sticked, bathe the back and paste better.

[taboo] forbidden pasting and used when property of drug changes.

Erythra appears in [points for attention] accidental subsides medicine place skin, but anti symptom treatment.

[storage] is airtight, puts shady and cool place.

[effect duration] 1.5 years.

Embodiment 2

Take by weighing each component raw material according to following weight parts:

20 parts of Daphne giraldii Nitsche fluid extracts, 6 parts of Borneolum Syntheticums, 12 parts of Camphoras, 9 parts of methyl salicylate, 10 parts of liguidamber resinoids, 18 parts of Semen daturae fluid extracts, 6 parts of Mentholums.

Manufacture method: get 20 parts of Daphne giraldii Nitsche fluid extracts, add 6 parts of Borneolum Syntheticums, 12 parts of Camphoras, 9 parts of methyl salicylate, 10 parts of liguidamber resinoids, 18 parts of Semen daturae fluid extracts, 6 parts of mixings of Mentholum, add again by 40 parts of rubber, 50 parts of zinc oxide, 40 parts of Colophonium, 12 parts of lanolines, 5 parts in vaseline, 3 parts of substrate of making of liquid paraffin, make coating, be coated with cream, cutting, the lid lining, section, specification: every 7cm * 10cm, packing: complex pocket, 7cm * 10cm * 10 are pasted * 2 bags.

Usage, consumption, taboo, points for attention, storage, effect duration are with embodiment 1.

Embodiment 3

Take by weighing each component raw material according to following weight parts:

15 parts of Daphne giraldii Nitsche fluid extracts, 4 parts of Borneolum Syntheticums, 8 parts of Camphoras, 6 parts of methyl salicylate, 5 parts of liguidamber resinoids, 12 parts of Semen daturae fluid extracts, 4 parts of Mentholums.

Manufacture method: get 15 parts of Daphne giraldii Nitsche fluid extracts, add 4 parts of Borneolum Syntheticums, 8 parts of Camphoras, 6 parts of methyl salicylate, 5 parts of liguidamber resinoids, 12 parts of Semen daturae fluid extracts, 4 parts of mixings of Mentholum, add again by 32 parts of rubber, 40 parts of zinc oxide, 32 parts of Colophonium, 8 parts of lanolines, 3 parts in vaseline, 2 parts of substrate of making of liquid paraffin, make coating, be coated with cream, cutting, the lid lining, section, specification: every 10cm * 12cm, packing: complex pocket, 10cm * 12cm * 15 are pasted * 2 bags.

Usage, consumption, taboo, points for attention, storage, effect duration are with embodiment 1.

In order to verify the good effect of medicine of the present invention, the inventor is in hospital of Xi'an Communications University, second Affiliated Hospital of Xi'an Communications University, Xi'an the 5th hospital, Red Cross Hospital of Xi-an City has carried out a large amount of experiments, now select the part clinical experiment report as follows, drug nomenclature of the present invention is ' a compound recipe Daphne giraldii Nitsche ZHITONG GAO '.

Test 1

Compound recipe Daphne giraldii Nitsche ZHITONG GAO is to 94 routine congealed shoulder observation of curative effect

Hospital of Xi'an Communications University

Compound recipe Daphne giraldii Nitsche ZHITONG GAO is adopted in our therapy of combining Chinese and Western medicine soft tissue injury outpatient service, after 94 routine congealed shoulder maneuvers are torn, carries out pain palliation efficacy and observes, and brief summary is as follows:

Ordinary circumstance:

Sex and age: specifically see Table 1

Table 1 94 routine congealed shoulder sexes, age

Sex	Age group
					Below 40 years old (people)	40-50 year (people)	More than 50 years old (people)	Subtotal (people)
	Both sexes	5 6 11	18 30 48	15 20 35					38 56 94

Inflammation can not get timely treatment in early days around the shoulder, and activity is improper again in addition, and with the passing of time delay forms articular cavity extensively adhesion on every side, and function is extremely limited, pain.To forming the patient who freezes, we adopt maneuver to tear to thaw, but after thawing, except that to the analgesic drug product treatment, still there is not ideal externally-used pain-relieving cream, after the Daphne giraldii Nitsche ZHITONG GAO is on probation, we get its expelling wind and removing dampness, anti-inflammatory analgesic, invigorate blood circulation, the repercussive characteristics, the pain relieving after being used for congealed shoulder and thawing is to observe its analgesic effect to severe pain.

Congealed shoulder is because extensively adhesion around the articular cavity, tear and thaw and be to carry out not having under the anesthesia, patient's sharp ache, what have cries bitterly, the trouble limb that has trembles, according to the pain classification, the pain after thawing belongs to level Four, for this pain, we are about to compound recipe Daphne giraldii Nitsche ZHITONG GAO and stick the affected part tearing the back that thaws, after the patient pastes, a kind of cool sense is arranged, make pain relief gradually subsequently and disappear.Its curative effect sees Table 2.

After thawing, adopt table 2 congealed shoulder compound recipe Daphne giraldii Nitsche ZHITONG GAO pain palliation efficacy to observe

Classification	Produce effects	Effectively	Invalid	Total responder
					Example number %	84 89.4	9 9.57	1 1.06	92 98.97

Test 2

Compound recipe Daphne giraldii Nitsche ZHITONG GAO 402 routine pain palliation efficacies are observed

Second Affiliated Hospital of Xi'an Communications University

Xi'an the 5th hospital

Red Cross Hospital of Xi-an City

Compound recipe Daphne giraldii Nitsche ZHITONG GAO is to be principal agent with the Chinese medicine Daphne giraldii Nitsche, makes plaster, and the Daphne giraldii Nitsche effective ingredient is auspicious existing glycoside and Daphne giraldii Nitsche Saponin, has expelling wind and removing dampness, and anti-inflammatory analgesic is invigorated blood circulation, effects such as detumescence.Second Affiliated Hospital of Xi'an Communications University, Xi'an the 5th hospital, Red Cross Hospital of Xi-an City have carried out the pain patients observation of curative effect of 402 examples, be used for the treatment of rheumatic arthritis, rheumatoid arthritis, scapulohumeral periarthritis, tennis elbow, lumbar muscle strain, cervical spondylosis, disease such as sprain, sciatica and rheumatism cause each myalgia of whole body and obtained certain curative effect, and compare group with the ZUSIMA GUANJIE ZHITONG GAO that Lanzhou Sanitary Materials Factory produces and compare observation.Now that the observed result summary report is as follows:

1, physical data:

1.1 sex, age: this organizes 402 examples, wherein male's 173 examples, account for 43.03%, women's 229 examples account for 56.96%, men and women's ratio is 1: 1.32, maximum 74 years old age, minimal ages 17 years old, age cohorts is with 41-50 year, be the highest 137 examples, account for 4.08%, 41-60 year 250 examples, account for 62.13%, each age group formation sees Table 1

Table 1 age group constitutes

	Sex		Age cohorts (year)
										The example number	Man 173	Woman 229	(21 2	21～30 49	31～40 59	41～50 137	51～60 113	＞60 42	Amount to 402

1.2, grouping: be divided into two groups of compound recipe Daphne giraldii Nitsche ZHITONG GAO group (treatment group) and ZUSIMA GUANJIE ZHITONG GAO groups (matched group).342 examples are organized in treatment, male 142 examples, women 200 examples, the patient age scope is 278 examples between 41～60 years old age, account for 93 examples between 69.15%, 21～40 years old age, account for 23.13%, matched group 60 examples, man's 31 examples, women 9 examples, the age is 44 examples between 41～60 years old age, account for 73.33%, 21～40 years old 15 example and account for 25%.

1.3 occupation: among these 402 routine patients, workman's 141 examples account for 35.0%; Other professional 56 examples account for 13.93%.Be many wherein with the cadre.This group cooperation unit all belongs to general hospital.

1.4 sick kind of each cooperation unit distributes, this organizes 402 pain patients has five section office of three units to observe, last 14 months surplus, each cooperation unit observes and puts into practice unevenly, case load is planted classification and is not quite similar with sick, sees Table 2.

Each cooperation unit's case of table 2 402 routine pain patients and the sick classification formation table of planting

2, case is selected

This group is to be the clinical observation of main purpose with the pain relieving, and emphasis is scapulohumeral periarthritis, rheumatic arthritis, and secondly other patient to rheumatoid arthritis, cervical spondylosis and obstinate pain has made observation of curative effect, selects the condition of case:

2.1 diagnosis is clear and definite, comprises pain history, symptom, sign.

2.2, the pain perception with obvious misery, function limitation, the patient who does not use medicine not alleviate.

3, treatment and observational technique and curative effect determinate standard

3.1, compound recipe Daphne giraldii Nitsche ZHITONG GAO administrated method: external, paste for one time 1, changed once in 24～48 hours.

3.2, curative effect determinate standard:

This organizes 402 routine pain classifications, according to patient's subjective sensation and joint function disturbance, with the pain classification:

0 promptly: pain is eliminated, and pain can be stood;

The I level: pain can tolerate, no malfunction;

The II level: have the part malfunction, pain is difficult to tolerance;

III level: have malfunction;

IV level: have serious malfunction.

3.3 pain changed in stages before and after the clinical verification medication is divided into three grades with pain palliation efficacy:

3.3.1 produce effects: treatment back pain disappears or alleviates and differs the above person of secondary;

3.3.2 effectively: pain relief differs one-level person;

3.3.3 invalid: pain does not have the changer.

3.4, rheumatic arthritis and rheumatoid arthritis curative effect determinate standard:

3.4.1 produce effects: arthroncus alleviates, pain is clearly better, and function of joint is improved.

3.4.2 effectively: arthroncus and function of joint situation all have certain improver.

3.4.3, invalid: symptom and sign no change.

4, observed result:

4.1, the total effects observed result, this organizes 402 routine pain patients clinical observation on the therapeutic effect results:

Obvious effective rate 42.29%, effective percentage 51.74%, total effective rate 94.03% sees Table 3.

The curative effect classification	Produce effects	Effectively	Invalid	Add up to
					The example number	Number % 170 42.29	Number % 208 51.74	Number % 24 5.97	Quantity 402

4.2 each principal disease analgesic effect observation of curative effect result: this organizes 402 routine pain patients, wherein principal disease rheumatic arthritis, rheumatoid arthritis, scapulohumeral periarthritis, tennis elbow, sprain, lumbar muscle strain, cervical spondylosis, sciatica, pain palliation efficacies such as hyperosteogeny, through statistical procedures, between each sick kind significant difference is arranged between its produce effects, effective, invalid, the total effective rate, see Table 4.

Each principal disease pain palliation efficacy observed result of table 4

X ²＝678.98 df=18 P<O.505

4.3 treatment group and matched group observation of curative effect result relatively for two medicine analgesic effects relatively, have carried out before and after two medicines self at random curative effect, the onset time of treatment, have held time and side effect compares observation 60 examples wherein.

4.3.1 the curative effect of treatment at random before and after self of two groups of medicines: this group at random 60 routine pain patients is treated and matched group self is treated observed result, sees Table 5.

Treat the observation of curative effect result before and after self of two groups of medicines of table 5 60 routine pain patients at random

X ²＝25.63 df＝2 P＜0.005

Compared significant difference by produce effects, effective, invalid ratio between the table 4 liang group by two groups of curative effects of statistical procedures (P＜0.005).

4.3.2 the two groups of medicine onsets and the comparison of holding time see Table 6.

Table 6 liang the group medicine onset time and the comparison of holding time

	Compound recipe Daphne giraldii Nitsche ZHITONG GAO			ZUSIMA GUANJIE ZHITONG GAO			T＝2.417 T＝3.3456
								The example number	Meansigma methods	Standard value	The example number	Meansigma methods	Standard value
	Onset time (branch) hold time (hour)	60 60	16.2 29.35	23.12 19.1	60 60	28.7 21.75								26.06 18.2

Two groups of medicines are learned processing by statistics, and significant difference P＜0.05 is arranged, and it is 29.35 hours that compound recipe Daphne giraldii Nitsche ZHITONG GAO 60 examples are on average held time, and ZUSIMA GUANJIE ZHITONG GAO 60 examples on average to hold time be 21.75 hours, compared obvious prolongation.

The comparison of (3) two groups of medicine side effect, it is documented that containing noxious substance in the Daphne giraldii Nitsche is diterpene ortho esters daphnegiradicin, side effect with chafe redness and blister, this group are carried out self side effect observation to 60 routine pain patients treatments and matched group at random, see Table 7.

Table 7 liang group medicine side effect comparison sheet

X ²＝25.63 df＝2 P＜0.05

Two groups of medicine side effect are learned to handle more by statistics significant difference (P＜0.05), and the side effect of compound recipe Daphne giraldii Nitsche ZHITONG GAO is less, and does not contain the artificial Moschus, and the anemia of pregnant woman can use.

The result: compound recipe Daphne giraldii Nitsche ZHITONG GAO prescription is formed with the pharmacological action aspect and all is better than Lanzhou Sanitary Materials Factory production ZUSIMA GUANJIE ZHITONG GAO.At first be to contain the principal agent amount greater than 6 times, toxicity is less than 3 times, and processing technology is reasonable, makes the more thorough of noxious substance eliminating.This product has mutual synergism aspect pharmacological action, strengthened the analgesia and the antiinflammation of Daphne giraldii Nitsche, and particularly Semen daturae extractum has pain relieving, the secretory action that suppresses the skin body of gland, reduce body fluid and get rid of, prevent and the formation of vesicle when reducing plaster that the fragrant fluid extract of cloud has the blood capillary of reduction gland by body surface, increase capillary resistance, prevent dermatorrhagia, reduced the erythema erythra and formed that this product does not contain the artificial Moschus, the excitation of unmatchful gravid uterus is so the anemia of pregnant woman needn't avoid.Therefore higher aspect clinical efficacy, effect is very fast, and it is longer to keep therapeutical effect, and side effect is lower.Be a more fine product, obtained the welcome of vast pain patients.

Seven, discuss

Pain is the defensive function of human body, also is the ruined index of normal condition, but for the patient who has clarified a diagnosis, treats curative effect so far and still can not be satisfied with.Both at home and abroad analgesics had once been carried out than broad research, the medicine analgesia opioid analgesicses that adopt more, antiinflammatory, febricide etc., as indometacin, Phenylbutazone, aspirin and compound preparation thereof etc.ZHITONG GAO has SHANGSHI ZHITONG GAO, and pain can be fitted musk rheumatic cream etc.But effect is all satisfied inadequately, and ZUSIMA GUANJIE ZHITONG GAO often causes that the skin irritation reaction is more and serious, and the doctor trained in Western medicine Second Academy has extracted daphnin from Daphne giraldii Nitsche, discharged daphnetoxin, has improved content of dispersion and curative effect greatly, has reduced side effect.Be applied to clinical verification 1 year, treat various pain 402 examples, obvious effective rate 42.29%, effective percentage 51.74%, inefficiency 5.97%, total effective rate 94.03%, this product advantage: curative effect height, rapid-action, the length of holding time, side effect is less, adhesion is strong, studies carefully its cause of invalidity and is because of due to the skin irritation reaction is discontinued medication greatly.

Analgesia index about pain, remain at defectiveness, from algesiogenic theory, because the pain sensation is at the subjective sensation in the consciousness field under the stimulation of focus, degree and character can only reach and pain reaction by means of patient's subjective sensation, be difficult to definite mensuration, be difficult to definite description again, lacking a kind of objective indicator changes with the nature and extent of observing sensation and pain reaction, we carry out the pain classification according to pain patients malfunction degree, subjective feeling and objective observation can be combined, and determine curative effect, have certain objectivity with its patient's malfunction recovery extent.

Test 3

The pharmacodynamic study of compound recipe Daphne giraldii Nitsche

The pharmacological action of compound recipe Daphne giraldii Nitsche ZHITONG GAO

One, the pharmacological research of Daphne giraldii Nitsche

The analgesic activity of Daphne giraldii Nitsche: Gansu Province Drug Testing Institute (1978) use the root of Daphne giraldii Nitsche, stem, leaf, the flower alcohol extract, through the mice hot-plate analgesic test, has certain analgesic activity, per kilogram weighs 0.2 gram crude drug, it is lasting that leaf and flower effect relax, side effect obviously reduces, and the peeling stem does not have analgesic activity, Nanjing pharmaceutical college (1975) adopts hot plate method: mice by intraperitoneal injection daphnetin 100mg/kg and dolantin 15mg/kg contrast p＜0.01, has significant analgesia role, use " pedalling " activity measurement result: movable obviously reduce (p＜0.01) of white mice in 15 minutes to white mice, 60 minutes and see recovery (p＞0.05), ancestral's Sima daphnetin (1974), adopt hot plate method: mouse peritoneal drug administration by injection 100mg/kg and dolantin 15mg/kg compare relatively p＜0.01 of group, have obvious analgesic activity.

1, the antiinflammatory action of Daphne giraldii Nitsche: pharmacology teaching and research group of Ningxia Medicine College to the alcohol extract of the root of the Ji Shi winter daphne of Liu Pan Shan product, peel of stem to rat test arthritis (albumen " arthritis ", dextran arthritis and formaldehyde ankle joint inflammation) have obvious inhibitory action (p＜0.01), this kind effect is more similar to sodium salicylate and slightly strong; Association's property exudative inflammation (formaldehyde " arthritis ") there is certain inhibitory action, but it is obvious not as good as hydrocortisone, association's property proliferative inflammation (granuloma induced by implantation of cotton pellets) is had obvious inhibitory action (with matched group comparing difference highly significant), and this kind effect is oral far beyond Phenylbutazone to be strong.Li Chenglin (1978) adopts the ancestral's Sima team Ovum Gallus domesticus album formaldehyde swollen joint that quivers with Gansu tangible antiinflammation.Intensity from antiinflammation, the effect of acetic acid cortisone 30mg/kg body weight skin 0.1 ~ 0.25g/kg body weight and subcutaneous rat or intramuscular injection of rat through irritating the stomach Daphne giraldii Nitsche is suitable, the rat of PARA FORMALDEHYDE PRILLS(91,95) arthroncus test, can both reduce the content of Vitamin C in its adrenal gland significantly, this point is similar to antirheumatic medicine, as salicylic acid preparation etc., its antiinflammation may be relevant with the excitement of adrenal gland's sebum function, may be direct effect, also may be by nerve--the effect of-hypothalamic hypophysial system.

2, numb antibacterial action: first, the second element that Nanjing pharmaceutical college (1975) extracts Daphne giraldii Nitsche is done the bacteriostasis test,

The results are shown in Table 1.

The plain bacteriostasis test of table 1 Daphne giraldii Nitsche first, second

Sample	Concentration	The strain growth situation
						The gold Portugal	Large intestine	Green pus	Fu Shi
		The plain daphne giraldii second of the plain daphne giraldii second of daphnetin daphnetin daphnetin daphnetin daphnetin daphne giraldii second is plain blank	1∶10000 2∶10000 5∶10000 10∶10000 20∶10000 20∶10000 5∶1 0000 10∶10000	- - - - - ++ - - +++	+++ + ± - - +++ + - +++					++ ++ - - - +++ - + +++	++ + - - - +++ - - +++

Above bacteriostatic test proves, daphnetin is for staphylococcus aureus, escherichia coli, and the growth of shigella flexneri is inhibited.

3, toxicity test: Daphne giraldii Nitsche and extract toxicity thereof see Table 2

Table 2 Daphne giraldii Nitsche toxicity test result

4, conclusion

The main chemical compositions that the compound recipe Daphne giraldii Nitsche plays the pain relieving effect is Daphne giraldii Nitsche daphnin and Daphne giraldii Nitsche Saponin, through pharmacological testing is effective ingredient, it and Camphora, Borneolum Syntheticum, wintergreen oil, the cooperation of Herba Menthae has strengthened analgesic effect, and refrigerant, detumescence, damp eliminating, antiinflammatory, effect such as anticorrosion, antipruritic are arranged, the special cooperation with Semen daturae and Folium Symplocoris Caudatae preparation strengthened curative effect, reduced side effect, prevent that skin blister from taking place, so this prescription rationally.

How much contain the principal agent amount from per jin, compound recipe Daphne giraldii Nitsche ZHITONG GAO contains ancestral's Sima 1.15 grams, exceeds nearly 6 times than Daphne giraldii Nitsche pain-relieving plaster for arthritis 0.2 gram, and therefore curative effect is higher aspect clinical treatment, and effect is very fast, the length of holding time, and side effect is lower.

Daphne giraldii Nitsche Study on extraction aspect, the main decocting wine that adopts is joined method, the effective ingredient glycoside is extracted fully, every content height, more thorough to the toxic component discharge, so compound recipe Daphne giraldii Nitsche ZHITONG GAO is through clinical 402 routine pain palliation efficacy observed results, obvious effective rate 42.29%, effective percentage 51.74%, inefficiency 5.97%, total effective rate is 94.03%, has the curative effect height, rapid-action, the length of holding time, side effect is less, toxicity is low, adhesion strength is strong, the advantage that stripping reaction is slighter, and anaphylaxis is very few, production technology is reasonable, simple to operate, save organic solvent, cost is lower.

Test 4

The test of compound recipe Daphne giraldii Nitsche ZHITONG GAO pain relieving reaction of animals

One, medicament sources:

Compound recipe Daphne giraldii Nitsche ZHITONG GAO is provided by Yangling Dongke Maidisen Pharmaceutical Co., Ltd.

The Daphne giraldii Nitsche pain-relieving plaster for arthritis is provided by Lanzhou Sanitary Materials Factory

Experimental animal: 12 of healthy rabbits

Two, test method: the outside, limb joint fur before and after the rabbit is cut, exposed skin 3 * 3cm, stick two kinds of plaster of 2 * 2cm immediately, put back to raise in the cage to take off in 24 hours and get rubber plaster, the skin of observing the place that forces on changes.

Three, observation index:

1, skin severe reaction produces vesicle or discharges secretions.

Erythema or erythema appear in 2, skin mild reaction.

3, dermoanergy, skin color is normal.

Four, observed result:

Compound recipe Daphne giraldii Nitsche ZHITONG GAO and reference substance, to dermoreaction, the result is as showing:

Table compound recipe Daphne giraldii Nitsche ZHITONG GAO is to the rabbit dermoreaction

Medicine name	Test portion value number	Dermoreaction
								Severe reaction		Mild reaction		Reactionless
		Number positional	％	Number positional	％	Number positional	％
								Compound recipe Daphne giraldii Nitsche ZHITONG GAO Daphne giraldii Nitsche pain-relieving plaster for arthritis amounts to	24 24 48	0 4 4	16.7	4 8 12	16.7 33.3	20 12 32	83.3 50

X ²＝7.344 n＝2 p＜0.05

Compound recipe Daphne giraldii Nitsche ZHITONG GAO group and control animals dermoreaction result of the test have the difference of significance, and (p＜0.05) proves that this medicine is little to the animal skin zest, and side effect is less.

Test 5

Model case

Case one

Zheng * *, the woman 47 years old, economizes the electric power cadre of designing institute, outpatient service number: No. 607107, right shoulder pain is limitation of activity half a year, invalid with laser, acupuncture, massage, come outpatient service to seek medical advice, have a medical check-up: suffer from anteflexion 90 degree of upward lifting of limb, lift 90 degree on the abduction, the right hand can reach left side shoulder, after stretch can reach right ilium after, manipulation is once promptly torn and is thawed, the back functional rehabilitation that thaws is normal, sticks compound recipe Daphne giraldii Nitsche ZHITONG GAO, and pasting the part, back has cool sense, pain is alleviated gradually, and pain disappears substantially after 8 hours, and manipulation is cured for 13 times.

Case two

Still * *, woman, 49 years old, the workman of Xi'an car light factory, outpatient service numbers No. 615386, right shoulder pain, limitation of activity 1 year comes outpatient service to go to a doctor, and haves a medical check-up: lift 80 degree before suffering from limb, lift 80 degree on the abduction, the right hand can and left side shoulder, after stretch and can reach fifth lumbar vertebra, tear behind the manipulation five times and thaw, the back functional rehabilitation that thaws is normal, sticks compound recipe Daphne giraldii Nitsche ZHITONG GAO, after four hours, pain relief disappears substantially, and 18 maneuvers of anteroposterior diameter are cured.

Case three

Lee * *, the man, 56 years old, Shaanxi Province's Building Research Establishment, the cadre, outpatient service numbers No. 301510, right shoulder pain, limitation of activity 1 year comes out-patient treatment.Have a medical check-up: bend before suffering from and upward lift 90 degree, lift 90 degree on the abduction, the right hand can reach left side shoulder, the back of the body is stretched and can be reached fifth lumbar vertebra, and manipulation thaws for twice, and functional rehabilitation is normal, stick after thawing compound recipe Daphne giraldii Nitsche ZHITONG GAO after eight hours pain relief disappear substantially, through the recovery from illness of No. 11 manipulations in front and back.

After past, our maneuver was thawed, use TONGKESHU, QIANGLI SHEXIANG FENGSHI GAO to come alleviating pain mostly.After adopting compound recipe Daphne giraldii Nitsche ZHITONG GAO, cross-reference, the wet pain relieving time of TONGKESHU and QIANGLI SHEXIANG FENGSHI GAO is about 10 hours, and compound recipe Daphne giraldii Nitsche ZHITONG GAO analgesic time, except that small number of patients pain relief more than ten hours, the overwhelming majority reached pain relief at 7,8 hours, made pain time shorten 3-4 hour.

In a word, over one year, we adopt compound recipe Daphne giraldii Nitsche ZHITONG GAO to alleviate severe pain after thawing, and effect is satisfied, after this ZHITONG GAO is used, except that one or two people by the skin generation allergy, most patients have no side effect after using.

Case four

The patient dragon * *, the man, 50 years old, the cotton yarn retired worker of factory in the Yellow River lived the 6th buildings, will go up every day downstairs for several times, caused the knee joint strain for a long time, and pain is difficult to stand, and both hands hold up banister to climb sometimes.Once with no desirable effects such as several analgesic plasters such as musk rheumatic cream and SHANGSHI ZHITONG GAO, examine to my gate and to seek medical advice, outpatient service numbers 330524, be diagnosed as the arthritis of lumbar muscle strain, use 10 of compound recipe Daphne giraldii Nitsche ZHITONG GAO, each 4 paste, kept two, paste back pain and alleviate greatly, cane is not gone upstairs, and five paste the back recovery from illness, patient is reflected: " the really good plaster of compound recipe ancestral Sima ZHITONG GAO; it is all better than other ZHITONG GAO, has cured cureless arthralgia, thank how do you do doctor ".

Case five

Patient king * *, the man, 64 years old, the resident, No. 599, Shang Delu, patient main suit, carpal joint and left limb arthralgia several months, various therapeutic schemes are produce effects not all.Clinical examination: type joint swelling, anti-" 0 " 7200LI, erythrocyte sedimentation rate 21mm/ml, the X-ray sheet, the matter degree increases between carpal joint, folliculus shape pathological changes, soft tissue is ossified in the compressor tuberosity, is diagnosed as rheumatic arthritis.Treat and adopt 10 bags of compound recipe Daphne giraldii Nitsche ZHITONG GAO, double antirheumatic for oral administration, swelling disappeared after patient pasted the 6-7 bag, pain relief, treat month surplus process clinical examination and clap the X-ray sheet: carpal joint and left femoral joint recover normally to have obtained remarkable result substantially.

Two attached institutes of Xi'an Communications University

Claims (4)

1. Chinese medicine unguentum for the treatment of soft tissue pain, form by active component and substrate, it is characterized in that, make the active component raw material medicine and consist of by weight: Daphne giraldii Nitsche fluid extract 10-20 part, Borneolum Syntheticum 2-6 part, Camphora 5-12 part, methyl salicylate 3-9 part, liguidamber resinoid 2-10 part, Semen daturae fluid extract 6-18 part, Mentholum 2-6 part;

Substrate consists of by weight: rubber 20-40 part, zinc oxide 30-50 part, Colophonium 20-40 part, lanoline 5-12 part, vaseline 2-5 part, liquid paraffin 1-3 part.

2. Chinese medicine unguentum for the treatment of soft tissue pain as claimed in claim 1, it is characterized in that described crude drug consumption is: 15 parts of Daphne giraldii Nitsche fluid extracts, 4 parts of Borneolum Syntheticums, 8 parts of Camphoras, 6 parts of methyl salicylate, 5 parts of liguidamber resinoids, 12 parts of Semen daturae fluid extracts, 4 parts of Mentholums.

3. Chinese medicine unguentum for the treatment of soft tissue pain as claimed in claim 1 is characterized in that described substrates quantity is: 32 parts of rubber, 40 parts of zinc oxide, 32 parts of Colophonium, 8 parts of lanolines, 3 parts in vaseline, 2 parts of liquid paraffin.

4. the Chinese medicine unguentum preparation method of the described treatment of claim 1 soft tissue pain is characterized in that, follows these steps to carry out:

Get the Daphne giraldii Nitsche fluid extract, add Borneolum Syntheticum, Camphora, methyl salicylate, liguidamber resinoid, Semen daturae fluid extract, Mentholum, mixing;

Add substrate, make coating, be coated with cream, the lid lining, section, promptly.