CN1038811C - Compound chloroethane aerosol - Google Patents

Compound chloroethane aerosol Download PDF

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Publication number
CN1038811C
CN1038811C CN93108518A CN93108518A CN1038811C CN 1038811 C CN1038811 C CN 1038811C CN 93108518 A CN93108518 A CN 93108518A CN 93108518 A CN93108518 A CN 93108518A CN 1038811 C CN1038811 C CN 1038811C
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China
Prior art keywords
aerosol
chloroethane
chinese medicinal
gram
medicinal liquor
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Expired - Fee Related
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CN93108518A
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CN1097594A (en
Inventor
袁锦松
翁碧叶
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Guangdong sports hospital
HEJIGONG PHARMACEUTICAL FACTORY GUANGZHOU
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Guangdong sports hospital
HEJIGONG PHARMACEUTICAL FACTORY GUANGZHOU
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Priority to CN93108518A priority Critical patent/CN1038811C/en
Publication of CN1097594A publication Critical patent/CN1097594A/en
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Publication of CN1038811C publication Critical patent/CN1038811C/en
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  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

The present invention relates to an outer application medicine for treating acute and closed traumatic injuries, which is an aerosol agent made from chloroethane, Chinese medicine wine and a projective agent. The outer application medicine for treating acute and closed traumatic injuries combines Chinese and western medicines and has the action of alleviating pain, eliminating swell, removing blood stasis, resisting inflammation, etc. The outer application medicine for treating acute and closed traumatic injuries also has the characteristics of high effect taking speed, long acting time and treatment of both manifestation and the root cause of diseases.

Description

Compound chloroethane aerosol
The present invention is that treatment is acute, the medicine for external use of closure traumatic injury.
Various acute closed property traumatic injury are common surgical diseases in the motion, mostly are unexpected generation, and PD is very fast, and pain is obvious, and as untimely processing, the state of an illness will increase the weight of, influence training and race.Traditional treating method is: the traditional Chinese medical science is used medicated wine, external application of ointment, but uses inconvenience, and curative effect is rapid inadequately.Doctor trained in Western medicine can adopt the cold compress pressure dressing.Usually use dry and cold, cold water, but use also inconvenience, and easily pollute the affected part.Doctor trained in Western medicine also can adopt the freezing aerosol of pure ethyl chloride, energy quick-acting antalgesic, anti-swollen, but do not have follow-up curative effect, fail to shorten the course of treatment energetically.
In the purpose of this invention is to provide that a kind of easy to use, first aid curative effect and follow-up curative effect have both, west bonded new medicine for external use---compound chloroethane aerosol.Commodity are called executes rich aerosol.The former pain speed by name aerosol that disappears.
The present invention be achieved in that it be in, the bonded pharmaceutical composition of Western medicine, add the aerosol that propellant is made by ethyl chloride, the Chinese medicinal liquor that contains Moschus, Radix Notoginseng, Cortex Phellodendri and Rhizoma Corydalis.
The suitable content of each component is in per 100 gram aerosols: contain Chinese medicinal liquor 7-10 gram, propellant 23-50 gram that ethyl chloride 40-70 restrained, contained Moschus, Radix Notoginseng, Cortex Phellodendri and Rhizoma Corydalis.
Chinese medicinal liquor with treatment traumatic injuries function is existing multiple, and the Chinese medicinal liquor of this product contains the ethanol extraction of Moschus, Radix Notoginseng, Cortex Phellodendri and Rhizoma Corydalis.
Contain the ethanol extraction of Moschus 0.08-0.13 gram, Radix Notoginseng 2.4-3.9 gram, Cortex Phellodendri 7.2-11.7 gram and Rhizoma Corydalis 4.8-7.8 gram in per 100 milliliters of Chinese medicinal liquor, surplus is an ethanol.
In the above-mentioned Chinese medicinal liquor, alcoholic acid purity 〉=95% is for well.
Known medicinal propellant has multiple, and this product has been selected dichlorodifluoromethane (being called for short F12) for use.
According to acute closed property damage clinical symptoms mainly is that sub-dermal soft tissue fracture, hemorrhage, injury produce pain, swelling, ecchymosis or situations such as hematoma and dysfunction, in prescription, selected the ethyl chloride that instant crymoanesthesia effect is arranged for use, the Chinese medicines such as Moschus, Radix Notoginseng, Cortex Phellodendri and Rhizoma Corydalis that add the energy blood circulation promoting and blood stasis dispelling, utilize ethyl chloride volatile, instant crymoanesthesia, detumescence, analgesic effect are arranged, play the pioneering role of drug effect in this product.Treat ethyl chloride after the volatilization of the skin surface of injury, the Chinese medicinal liquor that stays just continues infiltration, rise restore menstrual flow and invigorate blood circulation, blood stasis removing, analgesic effect, curative effect is prolonged.Obvious synergistic analgesia, antiinflammatory action are arranged.So this product is the anxious slow bonded aerosol of two-layer effect of the combination of a kind of Chinese and Western, priority.
The preparation process of this product is as follows:
One, the processing of container and valve member and assembling: this product must be incorporated with in the pressure vessel of special valve closed system.Clean, dry, assemble container and valve member standby with routine techniques through being up to the standards.
Two, Chinese medicinal liquor preparation.With Chinese crude drugs such as Moschus, Radix Notoginseng, Cortex Phellodendri, Rhizoma Corydalis with 95% or more highly purified ethanol stream extract 1 hour (adding behind the Moschus), it is standby to filter the back, and should meet Chinese medicinal liquor internal control quality standard.
Three, the packing of Chinese medicinal liquor.In above-mentioned ready each container (for example Aluminum Bottle), pack into the Chinese medicinal liquor of ormal weight.
Four, the packing of ethyl chloride.
Five, the packing of propellant.
In above-mentioned four, the five faults in diagnosis and treatment journey packing of ethyl chloride, propellant and Zha Gai, embedding routinely technology operate.
Six,, leak test quick-fried, examination spray, pick out defective semi-finished product through trying.Qualified on inspection, be product.
This product has following advantage:
1, easy to use.
2, have first aid and follow-up curative effect concurrently.
3, quickly alleviating pain, hemostasis, detumescence, short treating period.
4, have no side effect.
5, pollution clothes not.
This product has obtained the Ministry of Public Health New Drug Certificate.
Embodiment one,
The aerosol of every bottle of net weight 100 grams contains ethyl chloride 47 grams, Chinese medicinal liquor 8 grams and dichlorodifluoromethane 45 grams.The preparation of Chinese medicinal liquor: Moschus 0.13 gram, Radix Notoginseng 3.9 grams, Cortex Phellodendri 11.7 grams, Rhizoma Corydalis 7.8 grams, add 95% ethanol and carry out heat in right amount and carry, obtain 100 milliliters in medicated wine.Get wherein 8 gram Chinese medicinal liquor as the component of one bottle of aerosol.
Embodiment two,
The aerosol of every bottle of net weight 100 grams contains ethyl chloride 50 grams, Chinese medicinal liquor 9 grams and dichlorodifluoromethane 41 grams.The preparation of Chinese medicinal liquor: Moschus 0.11 gram, Radix Notoginseng 3.5 grams, Cortex Phellodendri 10 grams, Rhizoma Corydalis 6.8 grams, add 95% ethanol and carry out heat in right amount and carry, 100 milliliters in medicated wine.Get wherein 9 gram medicated wine as the component of one bottle of aerosol.
Embodiment three,
The aerosol of every bottle of net weight 100 grams contains ethyl chloride 60 grams, Chinese medicinal liquor 10 grams and dichlorodifluoromethane 30 grams.The preparation of Chinese medicinal liquor: Moschus 0.09 gram, Radix Notoginseng 3.0 grams, Cortex Phellodendri 8.5 grams, Rhizoma Corydalis 5.8 grams, add 95% ethanol and carry out heat in right amount and carry, obtain 100 milliliters in medicated wine and get wherein 10 gram medicated wine as the component of one bottle of aerosol.
Embodiment four,
The aerosol of every bottle of net weight 100 grams contains ethyl chloride 65 grams, Chinese medicinal liquor 11 grams and dichlorodifluoromethane 24 grams.Chinese medicinal liquor preparation: Moschus 0.08 gram, Radix Notoginseng 2.4 grams, Cortex Phellodendri 7.2 grams, Rhizoma Corydalis 4.8 grams, add 95% ethanol and carry out heat in right amount and carry, obtain 100 milliliters in medicated wine.Get wherein 11 gram medicated wine as the component of one bottle of aerosol.
Pharmacological action study
Pharmacodynamic experiment.Experimentation the easing pain and diminishing inflammation effect of compound chloroethane aerosol and key component ethyl chloride and medicated wine, and what collaborative or antagonism is arranged between component relatively.
Laboratory animal is selected ICR mice and CD rat for use.The animal of every kind of test all is divided into 5 groups at random: (1) blank group: (2) compound chloroethane single-dose group; (3) compound chloroethane multiple dosing group; (4) ethyl chloride matched group; (5) Chinese medicinal liquor matched group.
The analgesic test method adopts benzylpenicillin potassium to cause pain method and hot plate method; The antiinflammatory test method adopts Oleum Tiglii to bring out mice ear edema, and carrageenin causes the acute inflammation model of scorching rat paw edema and the influence of the scorching mice auricular concha of caused by dimethylbenzene xylene capillary permeability etc., and experimental result shows:
1, compound chloroethane aerosol has analgesic activity.Benzylpenicillin potassium is caused the pain that pain method and two kinds of analgesic model of hot plate method cause remarkable inhibitory action is all arranged.In the main component ethyl chloride and Chinese medicinal liquor of compound chloroethane aerosol, wherein ethyl chloride is not seen significant analgesic activity, Chinese medicinal liquor then can significantly suppress the mice benzylpenicillin potassium and cause pain, but do not see the pain due to the obvious inhibition hot plate stimulation, this explanation ethyl chloride and Chinese medicinal liquor have been share the obvious synergistic analgesic activity.
2, compound chloroethane aerosol has antiinflammation.Suppressing Fructus Crotonis oiliness swelling and suppressing in two kinds of acute inflammation models of carrageenin rat paw edema remarkable resist inflammation on repercussive function is arranged all: and the scorching mice auricular concha of caused by dimethylbenzene xylene capillary permeability is increased.
3, has certain synergism between each component of compound chloroethane aerosol, aspect analgesia, the comparison of antiinflammatory action effect, in the hot-plate analgesic test with suppress rat carrageenan swelling and increase causes aspect the scorching mice capillary permeability, all be better than ethyl chloride and Chinese medicinal liquor, illustrate that ethyl chloride and Chinese medicinal liquor share the obvious synergistic effect.
The analgesic activity persistent period difference test of compound chloroethane aerosol component ethyl chloride main and Chinese medicinal liquor with it.Result of the test: measure immediately after the administration, compound chloroethane aerosol, chloroethane aerosol and Chinese medicinal liquor all can make mice threshold of pain rate increase, and are respectively 84%, 63%, 30%.Compare (P<0.05) with normal saline, after the administration 1 hour, single do not had obvious analgesic effect with Chinese medicinal liquor or chloroethane aerosol, threshold of pain raising rate is respectively 2% and 4%, and compound chloroethane still has analgesic effect, raising rate in the threshold of pain is 78%, compare (P<0.05) with normal saline (18%), after the administration 2 hours, compound chloroethane, raising rate in the threshold of pain is 92% (<0.05), and experiment shows: compound chloroethane aerosol, chloroethane aerosol, Chinese medicinal liquor all has analgesic effect to mice immediately after medication, wherein compound chloroethane aerosol analgesia duration is longer than chloroethane aerosol or Chinese medicinal liquor group.
The research of toxic and side effects
Do toxicological test by the new drug approval requirement, result of the test: in the local toxicity test of compound chloroethane aerosol, auricular concha and rabbit trunk both sides skin irritation to rabbit are tested equal nonirritant, and the skin of Cavia porcellus is not had irritated reaction, and rabbit skin is not caused photosensitivity reaction.Show that this product is to the local skin free of toxic effects.
Clinical observation
Observed 329 examples through four hospital clinicals in 1985, and selected case to have: muscle injury, sprain, ligament sprain, articular sprain, fracture, bone are taken off, soft tissue contusion etc., the result is in 329 routine clinical treatment observations, produce effects 192 examples account for 58.36%; 115 examples that take a turn for the better account for 34.95%; Invalid 22 examples account for 6.69%, and total effective rate is 93.31%, do not find apparent side effect in clinical.
Requirement according to new drug approval in 1988, this product and ethyl chloride are done clinical control treatment and observed 116 examples, select sick kind of treatment to have: muscle draws, contusion, articular sprain, periosteum contusion, tendo calcaneus sprain, fracture dislocation, analgesia etc. before resetting.Result: have 116 routine clinical verifications of contrast to show, the effective percentage of compound chloroethane group and ethyl chloride group be close (being respectively 100% and 95.69%), but the excellent effect of compound chloroethane group and produce effects person's example number are far beyond ethyl chloride group height (being respectively 79.25% and 50.86%), handle through grade preface value method, prove the difference (P<0.01) that highly significant is arranged on the curative effect statistics between two groups, and when compound chloroethane aerosol is used, do not have and cause skin cold injury phenomenon, few side effects is so can think that its curative effect is better than ethyl chloride.
Nineteen ninety deliberates and decides according to the Ministry of Public Health medicine and evaluates suggestion, adopts two methods of educating to carry out 100 examples (100 example contrasts in addition) clinical research, with the characteristic of disease grading relatively, carries out the analgesic effect persistent period and observes, and the result shows:
1, compound chloroethane analgesia group degree is better than matched group ethyl chloride;
2, the compound chloroethane analgesic onset time is faster than ethyl chloride;
3, the compound chloroethane analgesia duration is longer than ethyl chloride;
4, have no side effect.
Quality analysis research
Physicochemical property research by this medicine, the mensuration of each medicine active ingredient is groped test, determined effective inspection analytical method, formulated than the tighter quality standard of domestic similar dosage form (aerosol), this quality standard, according to the new requirement of current aerosol quality, content uniformity inspection and jet test have been added.Loading amount and spray speed have all been stipulated certain limit.
Also on request 3-10 is criticized stability of drug in the research of this product quality analysis and has carried out experimentation and investigation, the result:
1, compound chloroethane aerosol is placed on cool dark place and preserved 1 year 08 months, and medicinal liquid color, abnormal smells from the patient, clarity and pulverability do not change.Sample kept sample 1 year, medicament contg and the basic no change of Chinese medicinal liquor active ingredient.
2, quicken medicine by heat treated and change, observe pH value and ultra-violet absorption spectrum equistability, experimental result shows for test agent stable.
3, three batches supply the test agent loading amount near required standard, also find to change through accelerated tests.
4, investigate ethyl chloride content and Chinese medicinal liquor active ingredient in compound chloroethane aerosol medicinal liquid and the finished product through accelerated tests, experimental result shows stable.
Model case:
1, what *, man, 20 years old, gymnast.
On June 26th, 1988 did and seethes layout somersault backwards when the place training of province sports team, was not steady on one's legs when landing, and turns over the position and sprain in ankle joint, and pain was very promptly handled by the doctor that goes along with the team at that time.
Look into: left external malleolus has moderate swelling, pays ligament place moderate tenderness, and passive functions is slightly limited, does not find that other is unusual, examines to ankle joint moderate outside the left side and sprains.
Through controlling 2 times with the compound chloroethane aerosol spray, in each 5 seconds, symptom disappears substantially after 20 hours, can participate in normal training in second day.
2, * *, man, 22 years old, technician.
Careless because of participating in basketball match, right external malleolus intraarticular turns over, and causes right outer ligament of ankle joint damage.Hinder prescription on individual diagnosis in back 12 hours, through spraying compound chloroethane aerosol 3 minutes, pain begins to alleviate after about 5 minutes; Pain obviously alleviates after for the second time spraying medicine; Substantially do not have the limping phenomenon after spraying medicine for the third time, do not have obvious pain recurrence later on.
3, leaf * *, woman, 44 years old, cadre.
First visit on July 28 in 1988, the main suit: left foot is sprained in walking accidentally before 10 hours, swells and ache obviously Ambulatory Activity inconvenience.
Look into: the obvious swelling of left sufficient external malleolus place's soft tissue, the ankle joint limitation of activity, it is obvious that the ligament tenderness is paid in the outside, diagnosis: the outer sprain of ankle of left side foot, to the compound chloroethane aerosol treatment, pain obviously alleviates after 5 minutes, main suit's pain and swelling disappears substantially during further consultation, and action is normal.
4, Deng * *, woman, 39 years old, workman.
First visit on May 3 in 1988.Three days causes of main suit are fallen and are dampened waist and sacrum pain and can not just sit.
Look into: sacrum caudal vertebra place soft tissue swelling, tenderness is obvious, the photo audit report: the subluxation of sacrum caudal vertebra.Through giving compound chloroethane aerosol treatment 3 minutes, row manual reduction success behind the pain relief.
5, old * *, man 20 years old, the athlete of Guangdong football team.
March 13 nineteen ninety was because of right sprain of knee joint 30 minutes, hold up by the companion and to go to a doctor, the right knee-joint pain of private prosecution very, can not walk and activity, look into the obvious tenderness in the inboard place of right knee joint, bend and stretch all obviously limited, but there are not deformity and crushing pain, examine to " right sprain of knee joint belongs to 3 grades of degree pain, after controlling with compound chloroethane aerosol spray 5 minutes; suffer from limb pain and begin to alleviate; spray medicine altogether 3 times, in each 5 seconds, begins to reduce to 2 grades of degree in 20 minutes; reduced to 1 grade of degree in 30 minutes; active and passive function is recovered normally substantially, and lasting analgesia reaches 2 hours, does not see former pain degree reproduction.
6, Feng * *, the man 26 years old, likes group's mansion workman
March 15 nineteen ninety, sprain left carpal joint, when examining injured 20 minutes, left wrist pain is felt bad, and was stiff.
On inspection: left carpal joint is little swollen, and tenderness is obvious, initiatively passive equal function limitation, but do not see fracture, dislocation sign, examine and be left sprain of carpal joint, belong to 3 grades of degree pain, through controlling with the compound chloroethane aerosol spray, affected part pain begins to alleviate after 5 minutes, and medicine is sprayed 3 times altogether in front and back, each 3 seconds, began to reduce to 2 grades of degree in 15 minutes, began to reduce to 1 grade of degree in 25 minutes, analgesia time was kept 120 minutes, did not see that former pain level degree reproduces.
7, horse * *, woman, 22 years old, southern mansion worker
On February 15 nineteen ninety, sprain right carpal joint, when examining injured 30 minutes.Tell right wrist pain and feel bad, stiff.On inspection, right carpal joint tenderness is obvious, and active functions is limited, and passive functions is fair, examines to be right sprain of carpal joint, belongs to 2 grades of degree pain.Through spray 5 seconds of compound chloroethane aerosol, affected part pain begins to alleviate after 5 minutes.Reduced to 1 grade of degree in 10 minutes, reduced to 0 grade of degree in 30 minutes, symptom and sign disappears, and does not see that pain occurs again after 120 minutes.

Claims (4)

1, a kind of pharmaceutical composition acute, the closure traumatic injury---compound chloroethane aerosol that is used for the treatment of is characterized in that adding the aerosol that propellant is made by ethyl chloride, the Chinese medicinal liquor that contains Moschus, Radix Notoginseng, Cortex Phellodendri and Rhizoma Corydalis.
2, aerosol according to claim 1 is characterized in that the Chinese medicinal liquor 7-11 gram, the propellant 23-50 gram that contain ethyl chloride 40-70 gram in per 100 gram aerosols, contain Moschus, Radix Notoginseng, Cortex Phellodendri and Rhizoma Corydalis.
3, aerosol according to claim 1 and 2 is characterized in that Chinese medicinal liquor contains the ethanol extraction of Moschus, Radix Notoginseng, Cortex Phellodendri and Rhizoma Corydalis.
4, aerosol according to claim 3 is characterized in that containing in per 100 milliliters of Chinese medicinal liquor the ethanol extraction that Moschus 0.08-0.13 gram, Radix Notoginseng 2.4-3.9 gram, Cortex Phellodendri 7.2-11.7 gram and Rhizoma Corydalis 4.8-7.8 restrain.
CN93108518A 1993-07-20 1993-07-20 Compound chloroethane aerosol Expired - Fee Related CN1038811C (en)

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Application Number Priority Date Filing Date Title
CN93108518A CN1038811C (en) 1993-07-20 1993-07-20 Compound chloroethane aerosol

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Application Number Priority Date Filing Date Title
CN93108518A CN1038811C (en) 1993-07-20 1993-07-20 Compound chloroethane aerosol

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CN1097594A CN1097594A (en) 1995-01-25
CN1038811C true CN1038811C (en) 1998-06-24

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Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104547290A (en) * 2013-10-12 2015-04-29 罗兴富 External used medicine for treating closed traumatic injury and preparation method thereof
CN105708945A (en) * 2016-02-03 2016-06-29 扬州大学 Traditional Chinese medicine aerosol composition for external use

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6187607A (en) * 1984-10-08 1986-05-06 Sankei Kagaku Kk Repellent for image of long-horned beetle

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6187607A (en) * 1984-10-08 1986-05-06 Sankei Kagaku Kk Repellent for image of long-horned beetle

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