CN1792370A - External use prepns. for wind-dispelling, removing-obstruction in channels to relieve pain - Google Patents
External use prepns. for wind-dispelling, removing-obstruction in channels to relieve pain Download PDFInfo
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Abstract
An exterior-applied Chinese medicine for dispelling wind, unblocking collaterals, relaxing tendon and alleviating pain is prepared from 6 Chinese-medicinal materials including menthol, turpentine, camphor, olive oil, etc.
Description
Technical field:
The present invention relates to a kind of pharmaceutical preparation, particularly relate to a kind of wintergreen oil that contains, Mentholum, Oleum Terebinthinae, Camphora, Oleum thymi vulgaris, the dispelling wind and removing obstruction in the collateral of olive oil, the pharmaceutical preparation of muscles and tendons relaxing to alleviate pain.
Background technology:
Rheumatic arthralgia, muscle sprain, arthralgia and mosquito bite are some common slight illness, generally use the medicine of some traumatic injury, wherein external used medicine is a lot.
In recent years, along with going deep into of clinical research, occurred the pharmaceutical preparation of a lot of dispelling wind and removing obstruction in the collateral, muscles and tendons relaxing to alleviate pain on the market, but existing medicine belongs to a bit and cures the symptoms, not the disease, some uses expensive composition, and some is cut and interrupt using owing to uncertain therapeutic efficacy in application process.
In view of this, the inventor developed a kind of easy to use, effect steadily, determined curative effect, dosage form is stable, quality controllable and the dispelling wind and removing obstruction in the collateral that has no side effect, the pharmaceutical preparation of muscles and tendons relaxing to alleviate pain, to satisfy the demand of extensive patients.
The inventor passes through wintergreen oil, Mentholum, and Oleum Terebinthinae, Camphora, Oleum thymi vulgaris, Fructus Canarii albi wet goods prepare successfully a kind of active drug preparation that is used for dispelling wind and removing obstruction in the collateral, muscles and tendons relaxing to alleviate pain in conjunction with prescription, have overcome the defective of prior art, have obtained beyond thought effect.
Pharmaceutical preparation of the present invention, wintergreen oil wherein is described below:
Wintergreen oil
Character: colourless to weak yellow liquid, meet ferrum and can become dark brown, the special odor of medicinal herbs is arranged.
Pharmacological toxicology: contain volatile oil, Main Ingredients and Appearance is methyl salicylate (96%-99%) in the oil.
Indication: be mainly used in medicine, toothpaste, wind dispelling oil and edible sandy soil type, cola type essence etc.
1. color shape: colourless or little yellow liquid;
2. fragrance: have natural Ilicis Purpureae fragrance;
3. relative density: 20/20 ℃, 1.180-1.189;
4. refraction index: 20 ℃, 1.534-1.538;
5. optical rotation: 20 ℃ ,+0.5 (degree)---1 (degree);
6. methyl salicylate content: more than 98%;
Former plant: Ilicis Purpureae holly
Machaka is high 1～3 meter.Be born in the shrubbery of hillside.Sprig has fine, soft fur.The leaf alternate; Blade ovum shape lanceolar, long 2～4 centimetres, the two sides hairiness.Bloom early summer; Spend the several axils that cluster, lavender or whites.The drupe sphere, redness when ripe.
1. acting as of the effective ingredient flavonoid glycoside of Radix Ilicis Pubescentis: (1) coronary artery dilator, blood flow increasing improves myocardial nutrition; (2) reduce myocardial oxygen consumption; (3) directly act on the peripheral blood vessel smooth muscle, distend the blood vessels blood pressure drops.Can remove the vasoconstriction that norepinephrine or hypertensin cause.
2. antibacterial action: preliminary test shows that staphylococcus aureus, Bacillus proteus, shigella flexneri and bacillus pyocyaneus are all had bacteriostasis.
3. antitussive, phlegm-dispelling functions: the water decoction of Radix Ilicis Pubescentis, the cough that mice sulfur dioxide is caused has antitussive effect, with the phenol red method proof of mice phlegm-dispelling functions is arranged.
Be used for the treatment of coronary atherosclerotic heart disease clinically, cerebral thrombosis, thromboangiitis obliterans, central serous chorioretinopathy, uveitis all has certain curative effect.
Mentholum wherein is described below:
Mentholum
Indication: the Herba Menthae brain-capacity optionally stimulates the Cold receptor of human body skin or mucosa, produces sense of cold reflection and creeping chill, causes the skin mucosa vasoconstriction, also can cause the blood vessel of deep tissue and shrink and produce therapeutical effect.External can pain relieving, antipruritic.
Untoward reaction: can cause local anaphylaxis or contact dermatitis.
Usage and dosage: external: embrocate affected part.
Dosage form: externally used solution agent
Camphora wherein is described below:
Camphora
Character: for the branch of Lauraceae aiphyllium Camphor tree, do, root, leaf is through sending out extraction volatile oil, the crystallization that the reuse fractionating process extracts from volatile oil with vapor distillation.For white crystalline powder or colourless translucent lump, there is the zest spy smelly, the tough hot back of distinguishing the flavor of is refrigerant; Volatile in the room temperature; Black smoke takes place during burning and the flame of light is arranged.Atomic water-soluble, be soluble in ethanol, ether, fatty oil or volatile oil, very easily be dissolved in chloroform.
Function cures mainly: control trusted subordinate's distending pain, beriberi, skin infection scabies, toothache, traumatic injury.1. dehumidifying parasite killing, warming and odynolysis: scabies is controlled in external, toothache, traumatic injury.2. having one's ideas straightened out, it is dirty to ward off, warming and odynolysis: be used for coma or erputive abdominal disease.Can be mixed with powder or medicated wine uses.3. be used for breathing and circulatory failure.Also be dermerethistica, to mucocutaneous stimulation arranged, externally-applied liniment can antipruritic, analgesia, treatment arthralgia and myalgia.Camphor preparations for oral administration can stimulate intestinal mucosa to increase enterokinesia reflectingly, has the wind dispelling effect.
Consumption usage 0.1～0.2g goes into powder or dissolves clothes with wine.Suitable amount used externally is ground into powder and is spread or transfer deposited.Use and notice that this product is poisonous, for oral administration suitable careful, and should control dosage, in order to avoid poison.Be not taken by pregnant women.
Oleum Terebinthinae wherein is described below:
Oleum Terebinthinae turpentime oil
Historical: the external skin excitants.For the oleoresin that oozes out in the some plants of Pinaceae Pinus through distillation or extract the volatile oil that obtains, originate in provinces such as Jiangxi, Hunan, Guangdong.State's pharmacopeia such as China, Japan, Britain, Switzerland, Australia, France, Hungary are all recorded.
Character and stability: be colourless extremely yellowish clear liquid; Smelly special, acrid in the mouth is store for a long time or is exposed in the air, and is smelly cumulative strong, color gradual change Huang; This product is inflammable, and dense smoke takes place during burning.Easily molten in ethanol, can mix arbitrarily with chloroform, ether or glacial acetic acid, insoluble in water.
Drug effect: be the external skin stimulant, penetration power is very strong, and can infiltrate deep tissue and be stimulation, blood circulation promoting, and have disinfective action concurrently.
Adapt to symptom: be applicable to arthritis, arthralgia, myalgia, neuralgia etc.
Oleum thymi vulgaris is a kind of spice, is used for makeup in a large number, also has certain drug effect.
Olive oil is the edible oil that extracts from fresh fruit, the pure physics first road cold pressing is filtered and is formed, need not refine, pure natural, be can directly oral edible oil, unique fragrance and taste are arranged, contain abundant monounsaturated fatty acid, vitamin E, the Natural antioxidant, be rich in vitamin A, D, E, K, F, these all are the content of the fatsoluble vitamin that is easy to by skin absorbs, especially vitamin E, contain 8 milligrams in per 100 gram olive oil, olive oil is in the moving fat sclerosis of prevention, coronary heart disease, aspect effects such as diabetes are remarkable, can promote the calcification and the growth of skeleton, the relieve chronic constipation, reduce the generation of colon cancer.
Summary of the invention:
The invention provides a kind of dispelling wind and removing obstruction in the collateral of external of liquid state, the pharmaceutical preparation of muscles and tendons relaxing to alleviate pain.
Pharmaceutical preparation of the present invention, contain following composition: wintergreen oil, Mentholum, Oleum Terebinthinae, Camphora, Oleum thymi vulgaris, olive oil, the proportioning of these compositions is as follows:
Wintergreen oil 15-60ml Mentholum 17-68g Oleum Terebinthinae 6-24ml
Camphora 4.5-18g Oleum thymi vulgaris 5-20ml olive oil 2.5-10ml
Preferred proportioning is as follows:
Wintergreen oil 30ml Mentholum 34g Oleum Terebinthinae 12ml
Camphora 9g Oleum thymi vulgaris 10ml olive oil 5ml
Wherein liquid substance is weighed with volume, and solid matter is weighed with weight.
Wherein with wintergreen oil, Mentholum, Oleum Terebinthinae, Camphora are main active constituents of medicine, Oleum thymi vulgaris and olive oil are auxiliary element.
More than forming when production and can increase or reduce according to corresponding proportion, can be unit with kilogram or litre as large-scale production, and amount can increase or reduce, but the constant rate of the proportioning between each composition.
Above composition is through suitably mixing, or the routine techniques method of employing galenic pharmacy, can make pharmaceutical preparation of the present invention.
The present invention has carried out preferably the preparation method of pharmaceutical preparation of the present invention, and the preferred manufacturing procedure that obtains is as follows:
According to quantity Oleum Terebinthinae, Mentholum, the Camphora of an amount of methyl salicylate and recipe quantity are put in the material-compound tank successively, stirred four to five hours, fill CL to Mentholum, Camphora, add Oleum thymi vulgaris, stir evenly, leave standstill, promptly.
The preparation method of pharmaceutical preparation of the present invention also is a part of the present invention.
Pharmaceutical preparation of the present invention, the raw material of wherein each kind of composition can have been bought from the market, also can from Chinese crude drug, extract acquisition with known conventional method, or obtain by the chemosynthesis mode by known synthetic method, the raw material that the present invention uses, preferably the finished product of pharmaceutical grade requires to meet pharmacopeia or the national drug standard of issuing.
The present invention also provides a kind of the method for quality control is carried out in pharmaceutical preparation of the present invention, and this method comprises following content, measures the character of product, and product is differentiated, product is checked, product is carried out assay.
The character of wherein said mensuration product, method is as follows:
[character] this product is a sundown clarification oily liquids.The special aroma of tool.
Wherein saidly product is differentiated method is as follows:
This product is got in [discriminating] (1), and to add dehydrated alcohol an amount of, makes the solution that every 1ml contains 80mg, as need testing solution.Other gets australene.The Camphora reference substance adds dehydrated alcohol and makes the solution that every ml contains 2mg, 4mg, in contrast product solution.Measuring according to gas chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 E), is immobile phase with SE-30, and coating concentration is 5%, is carrier with Chromosorb W (AW-DMCS) (60-80 order).105 ℃ of column temperatures, accurate need testing solution and each 1 μ l of reference substance solution of drawing, the difference inject gas chromatograph, test sample should present the chromatographic peak identical with the reference substance retention time.
(2) get need testing solution in the discriminating (1) as need testing solution, other gets methyl salicylate, Mentholum reference substance, adds dehydrated alcohol respectively and makes the solution that every 1ml contains 4mg, in contrast product solution.By gas chromatography determination under [assay] item, test sample should present the chromatographic peak identical with the reference substance retention time.Wherein saidly product is checked method is as follows:
[inspection] relative density should be 0.940-0.980 (an appendix VII of Chinese Pharmacopoeia version in 2000 A).
Index of refraction should be 1.450-1.500 (an appendix VII of Chinese Pharmacopoeia version in 2000 F).
Wherein said product is carried out assay, method is as follows:
[assay] measured according to gas chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B),
System suitability test is immobile phase with PEG-20M, and coating concentration is 10%, is carrier (60-80) with ChromosorbW (AW-DMCS).115 ℃ of column temperatures, theoretical cam curve are calculated with the methyl salicylate kurtosis should be not less than 1500, and the separating degree of Mentholum and naphthalene should be up to specification.
Correction factor is measured and is got naphthalene 150mg.The accurate title, decide, and puts in the 100ml measuring bottle, adds anhydrous alcohol solution and be diluted to scale, as inner mark solution.Other gets methyl salicylate, each 20mg of Mentholum reference substance, and accurate the title decides, and puts in the 10ml measuring bottle, and the accurate inner mark solution 2ml that adds adds dehydrated alcohol and is diluted to scale, shakes up, and gets 1 μ, 1 inject gas chromatograph.The calculation correction factor.
The need testing solution preparation is got the about 80mg of this product with mensuration, and accurate the title decides, and puts in the 10ml measuring bottle, and the accurate inner mark solution 2ml that adds adds dehydrated alcohol and is diluted to scale, shakes up, as need testing solution.Get 1 μ, 1 inject gas chromatograph, measure, calculate, promptly.
This product contains Mentholum (C
10H
20O) should be 28.9-39.1% (g-g).
Contain methyl salicylate (C
2H
2O
3) should be 25.5-34.5% (g/g).
Pharmaceutical preparation of the present invention has following [function cures mainly]: dispelling wind and removing obstruction in the collateral, muscles and tendons relaxing to alleviate pain; Be used for rheumatic arthralgia, muscle sprain, arthralgia and mosquito bite etc.
Pharmaceutical preparation of the present invention its [usage and dosage] is wiped in the affected part for suitable amount used externally.
Pharmaceutical preparation of the present invention its [points for attention] is external.Avoid for oral administration.Avoid contacting eyes, wound, mucosa and sensitive skin.The skin injury person should not use.
In the above method of quality control, described this product is the pharmaceutical preparation of the present invention according to the method preparation of the embodiment of the invention, the preferably pharmaceutical preparation of embodiment 3.
Pharmaceutical preparation of the present invention can be made into the product of 25ml/ bottle or 50ml/ bottle, also can make the product of other specifications as required, as 5ml, and 10ml, 15ml, 20ml, 30ml, 40ml, 100ml or the like.
Pharmaceutical preparation of the present invention is good through a large amount of pharmacodynamic study proving effects:
About pharmacodynamic experiment method and result as follows:
Experimental technique
By following 15 pharmacodynamic experiments, check is tried thing and whether is had effects such as analgesia, antiinflammatory and immunomodulating; After being applied to local organization, whether can cause irritant reaction and anaphylaxis.
Analgesic experiment
The thermostimulation experiment
1. the mice hot water tail method that contracts
2. mice hot plate method
The electricity irritation experiment
3. mouse tail electrostimulation
The chemical stimulation experiment
4. the subcutaneous method that penetrates of rat potassium ion
5. mice acetic acid twisting method
6. mice formalin is licked sufficient method
The antiinflammatory experiment
7. carrageenin causes the rat paw edema method
8. the swollen method of rat granuloma
9. dimethylbenzene induced mice ear corridor swelling method
The immunomodulating experiment
10. to the influence (the mice carbon granule is cleaned up method) of mice reticuloendothelial system phagocytic function
(11) to the influence (dinitrochlorobenzene provocation method) of mice DCHR
(12) to the influence (sheep red blood cell (SRBC) revulsion) of mice hemolytic antibody generative capacity
Local application's irritant experiment and anaphylaxis experiment
Irritant experiment
(13) rabbit skin irritant test
(14) rabbit eye mucosa irritant test
The anaphylaxis experiment
(15) guinea pig skin hypersensitive test
Experimental result
Aspect analgesic activity
Mice 1.5h pain response latency after administration that pharmaceutical preparation low dose group of the present invention (0.05g/kg) is stimulated by hot water obviously prolongs, and with time period solvent matched group relatively, significant difference (P＜0.05) is arranged; Mice 1h after administration that the low dose group of pharmaceutical preparation of the present invention (0.05g/kg) is stimulated by hot water, 1.5h, pain response latency during 2h obviously prolongs, with comparison before the administration, significant difference (P＜0.05) is arranged, mice 1.5h after administration that the middle dosage group (0.10g/kg) of pharmaceutical preparation of the present invention is stimulated by hot water, pain response latency during 2h obviously prolongs, with comparison before the administration, utmost point significant difference (P＜0.01) is arranged, the high dose group of pharmaceutical preparation of the present invention (0.20g/kg) is obviously prolonged by mice that hot water the stimulates pain response latency during 1h after administration, with comparison before the administration, significant difference (P＜0.05) is arranged, illustrate that pharmaceutical preparation of the present invention is low, in, stimulate the pain that causes to have significant analgesia role to mice by hot water during high dose, yet as if this effect do not have dose dependent.
The basic, normal, high dosage group of pharmaceutical preparation of the present invention (being respectively 0.05g/kg, 0.10g/kg, 0.20g/kg) does not obviously influence the pain threshold that mice is stimulated by plate, with with period solvent matched group relatively, there is not significant difference (P＞0.05), and the pain threshold after the administration when 0.5h, 1h, 2h, 3h, with comparison before the administration, do not have significant difference (P＞0.05) yet, illustrate that the basic, normal, high dosage of pharmaceutical preparation of the present invention does not have significant analgesia role to mice by the pain that hot plate stimulates its vola to cause.
High doses group of the present invention (0.20h/kg) can make the mice 1h after administration that is subjected to electricity irritation, 1.5h the analgesia rate obviously improve, with with time period solvent matched group relatively, the mice analgesia rate of 1.5h after administration that has significant difference (P＜0.05) pharmaceutical preparation low dose group of the present invention (0.05g/kg) to make to be subjected to electricity irritation obviously improves, with with time period solvent matched group relatively, significant difference (P＜0.05) is arranged, illustrate that pharmaceutical preparation of the present invention is low, during high dose mice is had significant analgesia role by the pain that electricity irritation causes, yet this effect there is not tangible dose dependent.
Dosage group (0.05g/kg) can increase rat and cause the back threshold value of crying of reaction bitterly because of the subcutaneous potassium ion that penetrates in the pharmaceutical preparation of the present invention, compare with the solvent matched group, significant difference ((P＜0.05) is arranged, high doses group of the present invention (0.10g/kg) can increase rat and cause the shout threshold value and the back threshold value of crying of reacting bitterly because of the subcutaneous potassium ion that penetrates, compare with the solvent matched group, significant difference (P＜0.05) is arranged, illustrate in the pharmaceutical preparation of the present invention, as if high dose is penetrated the pain that chemical substance (potassium ion) causes significant analgesia role is arranged by subcutaneous rat, and this effect has dose dependent.
High doses group of the present invention (0.20g/kg) can make the body number of times of turning round of the mice of lumbar injection aqueous acetic acid obviously reduce, compare with the solvent matched group, significant difference (P＜0.05) is arranged, illustrate that pharmaceutical preparation of the present invention has significant analgesia role to mice by the pain that lumbar injection chemical substance (acetic acid) causes when high dose, and this effect has dose dependent.
Dosage group (0.10g/kg) can make the mice of subcutaneous injection formlinata aquae concentratac lick left back sufficient number of times in the 18-20min after injection obviously to reduce in the pharmaceutical preparation of the present invention, with with time period solvent matched group relatively, significant difference (P＜0.05) is arranged, the mice that high doses group of the present invention (0.20g/kg) can make the subcutaneous injection formlinata aquae concentratac is after injection in the 1min and lick left back sufficient number of times in the 18-20min and obviously reduce, with with time period solvent matched group relatively, significant difference (P＜0.05) is arranged, illustrate pharmaceutical preparation of the present invention in, during high dose mice is had significant analgesia role by the pain that subcutaneous injection chemical substance (formalin) causes, and this effect has dose dependent.
Aspect antiinflammatory action
Dosage group (0.05g/kg) can reduce the foot swelling rate of rat due to the carrageenin in the pharmaceutical preparation of the present invention when causing scorching back 4h, with with time segment model matched group, significant difference (P＜0.05) is arranged, high doses group of the present invention (0.10g/kg) is causing scorching back 3h, 4h, 5h, can reduce the foot swelling rate of rat due to the carrageenin during 6h, with with time segment model matched group relatively I, utmost point significant difference (P＜0.01-0.001) is arranged, illustrate in the pharmaceutical preparation of the present invention, high dose has the effect of the inflammation that Chinese People's Anti-Japanese Military and Political College Mus causes by carrageenin, and this effect is directly proportional with dosage.
Pharmaceutical preparation of the present invention has the obvious suppression effect to rat by implanting the granuloma that cotton balls brought out when middle and high dosage (being respectively 0.05g/kg, 0.10g/kg), with model control group, significant difference (P＜0.05) is arranged, illustrate that the middle and high dosage of pharmaceutical preparation of the present invention has opposing by the effect of implanting the inflammation that cotton balls brought out, yet as if this effect and dosage there is not dependency.
Pharmaceutical preparation low dosage of the present invention (0.05g/kg) has the effect of inflammation due to the anti-dimethylbenzene, with model control group relatively, utmost point significant difference (P＜0.01) is arranged, and should effect as if irrelevant with the dosage size of test sample.、
Aspect immunomodulating
In the clearance test of mice carbon granule, the k value (phagocytic index) of each dosage group of pharmaceutical preparation of the present invention, α value (engulfing coefficient) change little, compare with the solvent matched group, do not have significant difference (P＜0.05), illustrate that each dosage of pharmaceutical preparation of the present invention does not have obvious influence to the phagocytic function of mice reticuloendothelial system.
Bring out in the test of mice DCHR at dinitrochlorobenzene, pharmaceutical preparation of the present invention can strengthen dinitrochlorobenzene induced mice DCHR when low, middle dosage (being respectively 0.05g/kg, 0.10g/kg), compare with the solvent matched group, significant difference (P＜0.05) is arranged, illustrate that pharmaceutical preparation of the present invention can strengthen dinitrochlorobenzene induced mice DCHR when low, middle dosage, yet this effect there is not dose dependent.
Inductive mice hemolytic antibody generates in the test in sheep red blood cell (SRBC) institute, high doses group of the present invention (0.20g/kg) the lumbar injection sheep red blood cell (SRBC) that can raise carries out the half hemolysis value of mice immunized, compare with model control group, utmost point significant difference (P＜0.01) is arranged, illustrate that high doses of the present invention can promote the generation of the specific antibody of being brought out by sheep red blood cell (SRBC) in the mice body, and as if this effect has dose dependent.
Aspect local application's irritant reaction and anaphylaxis
In the skin irritation test of single-dose (external), pharmaceutical preparation of the present invention is not seen irritative response to new blue rabbit skin, illustrates that pharmaceutical preparation of the present invention does not have zest to new zealand rabbit single dermatologic.
In the eye mucosa film irritant test of single-dose (external), pharmaceutical preparation of the present invention has certain zest to New Zealand's lagophthalmos conjunctiva in administration 24h, be embodied in slight congested, the edema of a conjunctiva, secretions increases, this zest weakens gradually behind the 24h, substantially disappear to 72h, illustrate that pharmaceutical preparation of the present invention has slight zest to the eye mucosa of new zealand rabbit.
In skin allergy test, pharmaceutical preparation of the present invention does not produce anaphylaxis to guinea pig skin, illustrates that pharmaceutical preparation of the present invention does not have anaphylaxis to Cavia porcellus repeated multiple times dermatologic.
Pharmaceutical formulation of the present invention is to obtain through a large amount of screenings, be most preferred prescription, its screening process has been passed through a large amount of comparative experiments research, and final certification prescription effect of the present invention is good, and synergism is strong, the sense of taste is good, be coated onto on the skin and feel all right, nonirritant has no side effect, do not have irritated reaction, embodiments of the invention are representatives of most preferred prescription composition of the present invention and preparation method.
The specific embodiment:
By the following examples, further specify the present invention, but not as limitation of the present invention.
Embodiment 1
Wintergreen oil 15ml Mentholum 17g Oleum Terebinthinae 6ml
Camphora 4.5g Oleum thymi vulgaris 5ml olive oil 2.5ml
Preparation method is as follows:
According to quantity Oleum Terebinthinae, Mentholum, the Camphora of an amount of methyl salicylate and recipe quantity are put in the material-compound tank successively, stirred four to five hours, fill CL to Mentholum, Camphora, add Oleum thymi vulgaris, stir evenly, leave standstill, promptly.
Embodiment 2
Wintergreen oil 60ml Mentholum 68g Oleum Terebinthinae 24ml
Camphora 18g Oleum thymi vulgaris 20ml olive oil 10ml
Preparation method is as follows:
According to quantity Oleum Terebinthinae, Mentholum, the Camphora of an amount of methyl salicylate and recipe quantity are put in the material-compound tank successively, stirred four to five hours, fill CL to Mentholum, Camphora, add Oleum thymi vulgaris, stir evenly, leave standstill, promptly.
Embodiment 3
Wintergreen oil 30ml Mentholum 34g Oleum Terebinthinae 12ml
Camphora 9g Oleum thymi vulgaris 10ml olive oil 5ml
Preparation method is as follows:
According to quantity Oleum Terebinthinae, Mentholum, the Camphora of an amount of methyl salicylate and recipe quantity are put in the material-compound tank successively, stirred four to five hours, fill CL to Mentholum, Camphora, add Oleum thymi vulgaris, stir evenly, leave standstill, promptly.
Claims (8)
1, the external medicine preparation of a kind of dispelling wind and removing obstruction in the collateral, muscles and tendons relaxing to alleviate pain is characterized in that, is made by the component of following proportioning
Wintergreen oil 15-60ml Mentholum 17-68g Oleum Terebinthinae 6-24ml
Camphora 4.5-18g Oleum thymi vulgaris 5-20ml olive oil 2.5-10ml.
2, the pharmaceutical preparation of claim 1 is characterized in that, is made by the component of following proportioning
Wintergreen oil 30ml Mentholum 34g Oleum Terebinthinae 12ml
Camphora 9g Oleum thymi vulgaris 10ml olive oil 5ml.
3, the pharmaceutical preparation of claim 1 is characterized in that, wherein also contains an amount of methyl salicylate.
4, the pharmaceutical preparation of claim 1, it is characterized in that, be to prepare: according to quantity Oleum Terebinthinae, Mentholum, the Camphora of an amount of methyl salicylate and recipe quantity are put in the material-compound tank successively through following steps, stirred four to five hours, fill CL to Mentholum, Camphora, add Oleum thymi vulgaris, stir evenly, leave standstill, promptly.
5, the preparation method of the pharmaceutical preparation of claim 1 is characterized in that, is passed through being mixed and made into by the component of claim 1 proportioning.
6, the preparation method of claim 5, it is characterized in that, described mixing process following steps: according to quantity Oleum Terebinthinae, Mentholum, the Camphora of an amount of methyl salicylate and recipe quantity are put in the material-compound tank successively, stirred four to five hours, fill CL to Mentholum, Camphora, add Oleum thymi vulgaris, stir evenly, leave standstill, promptly.
7, the method for quality control of the pharmaceutical preparation of claim 1 is characterized in that, may further comprise the steps, and measures the character of product, and product is differentiated, product is checked, product is carried out assay.
8, the method for quality control of claim 7 is characterized in that, in the described step,
The character of wherein said mensuration product, method is as follows:
[character] this product is a sundown clarification oily liquids, the special aroma of tool;
Wherein saidly product is differentiated method is as follows:
This product is got in [discriminating] (1), and to add dehydrated alcohol an amount of, make the solution that every 1ml contains 80mg, as need testing solution, other gets australene, the Camphora reference substance, add dehydrated alcohol and make the solution that every ml contains 2mg, 4mg, product solution is measured according to gas chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 E) in contrast, is immobile phase with SE-30, coating concentration is 5%, is carrier with Chromosorb W (AW-DMCS) (60-80 order); 105 ℃ of column temperatures, accurate need testing solution and each 1 μ l of reference substance solution of drawing, the difference inject gas chromatograph, test sample should present the chromatographic peak identical with the reference substance retention time;
(2) get need testing solution in the discriminating (1) as need testing solution, other gets methyl salicylate, Mentholum reference substance, adds dehydrated alcohol respectively and makes the solution that every 1ml contains 4mg, in contrast product solution; By gas chromatography determination under [assay] item, test sample should present the chromatographic peak identical with the reference substance retention time; Wherein saidly product is checked method is as follows:
[inspection] relative density should be 0.940-0.980 (an appendix VII of Chinese Pharmacopoeia version in 2000 A);
Index of refraction should be 1.450-1.500 (an appendix VII of Chinese Pharmacopoeia version in 2000 F);
Wherein said product is carried out assay, method is as follows:
[assay] measured according to gas chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), system suitability test is immobile phase with PEG-20M, coating concentration is 10%, with ChromosorbW (AW-DMCS) is carrier (60-80), 115 ℃ of column temperatures, theoretical cam curve is calculated with the methyl salicylate kurtosis should be not less than 1500, and the separating degree of Mentholum and naphthalene should be up to specification;
Correction factor is measured and is got naphthalene 150mg, and accurate the title decides, and puts in the 100ml measuring bottle, adds anhydrous alcohol solution and is diluted to scale, as inner mark solution; Other gets methyl salicylate, each 20mg of Mentholum reference substance, and accurate the title decides, and puts in the 10ml measuring bottle, and the accurate inner mark solution 2ml that adds adds dehydrated alcohol and is diluted to scale, shakes up, and gets 1 μ l inject gas chromatograph; The calculation correction factor;
The need testing solution preparation is got the about 80mg of this product with mensuration, and accurate the title decides, and puts in the 10ml measuring bottle, and the accurate inner mark solution 2ml that adds adds dehydrated alcohol and is diluted to scale, shakes up, as need testing solution; Get 1 μ l inject gas chromatograph, measure, calculate, promptly;
This product contains Mentholum (C
10H
20O) should be 28.9-39.1% (g-g);
Contain methyl salicylate (C
2H
2O
3) should be 25.5-34.5% (g/g).
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005101232238A CN100356937C (en) | 2005-11-15 | 2005-11-15 | External use prepns. for wind-dispelling, removing-obstruction in channels to relieve pain |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005101232238A CN100356937C (en) | 2005-11-15 | 2005-11-15 | External use prepns. for wind-dispelling, removing-obstruction in channels to relieve pain |
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| Publication Number | Publication Date |
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| CN1792370A true CN1792370A (en) | 2006-06-28 |
| CN100356937C CN100356937C (en) | 2007-12-26 |
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| CNB2005101232238A Active CN100356937C (en) | 2005-11-15 | 2005-11-15 | External use prepns. for wind-dispelling, removing-obstruction in channels to relieve pain |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103989794A (en) * | 2014-05-15 | 2014-08-20 | 华东理工大学 | Traditional Chinese medicine preparation for regulating channels and activating collaterals of human body and preparation method thereof |
| CN107247110A (en) * | 2017-05-09 | 2017-10-13 | 广州白云山医药集团股份有限公司白云山何济公制药厂 | A kind of method for qualitative and quantitative detection of the clean gargle of mouth |
| CN113440580A (en) * | 2020-03-24 | 2021-09-28 | 康玲 | External medicinal preparation for relaxing muscles and tendons, promoting blood circulation, dispelling pathogenic wind and relieving pain |
Family Cites Families (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1044860C (en) * | 1993-08-09 | 1999-09-01 | 赖玉良 | Rheumatism medicine |
| CN1209149C (en) * | 2003-03-18 | 2005-07-06 | 彭少明 | Huoluo oil |
-
2005
- 2005-11-15 CN CNB2005101232238A patent/CN100356937C/en active Active
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103989794A (en) * | 2014-05-15 | 2014-08-20 | 华东理工大学 | Traditional Chinese medicine preparation for regulating channels and activating collaterals of human body and preparation method thereof |
| CN107247110A (en) * | 2017-05-09 | 2017-10-13 | 广州白云山医药集团股份有限公司白云山何济公制药厂 | A kind of method for qualitative and quantitative detection of the clean gargle of mouth |
| CN113440580A (en) * | 2020-03-24 | 2021-09-28 | 康玲 | External medicinal preparation for relaxing muscles and tendons, promoting blood circulation, dispelling pathogenic wind and relieving pain |
Also Published As
| Publication number | Publication date |
|---|---|
| CN100356937C (en) | 2007-12-26 |
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