CN1498614A - Camphor spraying agent as well as its producing method and product - Google Patents

Abstract

A camphor spray for treating the skin swelling caused by different reasons is prepared from camphor and alcohol solution. Its preparing process and the medicines containing it are also disclosed. Its advantage is high curative effect.

Description

Camphora spray and preparation method thereof and goods

Technical field

The present invention relates to drug world, be specifically related to a kind of Camphora spray that is used to eliminate skin swelling and pain and preparation method thereof and goods.

Background technology

Up to now, as the external used medicine that is used to subside a swelling, Camphora is contained in the analgesic, existing various schemes propose.

Disclose a kind of external camphor liniment that is used to eliminate skin swelling and pain among the Chinese patent application No.99119811.5, this liniment is that Camphora is dissolved in the saturated solution in the ethanol of 70%-95%.The manufacture method of this camphor liniment is specific as follows: will be dissolved in the ethanol of 70%-95% through the Gum Camphor that refines, the concentration that reaches capacity seals preservation then.In the time of 31 ℃, 91.5 gram Gum Camphors are dissolved in 50ml ethanol/water (V _Ethanol: V _Water=19: 1) in the solution, final volume is 145ml, makes the saturated alcoholic solution of Camphora-95%; 68.0 gram Gum Camphors are dissolved in 50ml ethanol/water (V _Ethanol: V _Water=9: 1) in the solution, final volume is 118ml, makes the saturated alcoholic solution of Camphora-90%; 31.2 gram Gum Camphors are dissolved in the 50ml ethanol/water, and (V: V=7: 3) in the solution, final volume is 64ml, makes the saturated alcoholic solution of Camphora-70%.This camphor liniment can be used for treating the initial stage skin of lower extremity redness that skin ulcer, carbuncle, the skin infection that is mainly caused by unknown cause, innominate toxic swelling that thermal stimulus causes and diabetes cause.Its pharmacology is: Camphora increases the permeability of affected part blood vessel, makes the inside and outside histamine's content of cell obtain balance, thereby reaches the repercussive effect.

Yet, implementation result is not good owing to there is following shortcoming for disclosed technical scheme in this patent application: at first, in the process for preparation of above-mentioned camphor liniment, because the preparation temperature requirement is under 31 ℃ of conditions, therefore can cause a large amount of volatilizations of alcoholic solution, make that Camphora is difficult to all be dissolved in 95% alcoholic solution under the condition of determining unit volume, ratio error is bigger mutually with the expection compound concentration, thereby can't reach expected effect; Secondly, in the process for preparation of above-mentioned camphor liniment, do not determine the concentration (promptly Pei Zhi standard only limits to prepare alcoholic acid saturated solution) of effective pharmaceutical compositions-Camphora owing to only determined the concentration of alcoholic solution, and the content of Camphora depends on factors such as preparation temperature and mechanical vibration in this saturated solution, thereby makes that this active drug composition of Camphora can't be accurately quantitative in the solution; The 3rd, when this liniment was applied in skin surface, because the ethanol highly volatile, the result caused in the saturated solution Camphora to be separated out rapidly being powdery being covered in skin surface, suffers from face thereby make medicine can't act on local skin equably; The 4th, the liquid medicine consumption of this liniment is difficult for grasping, and can trickle everywhere, often makes medicine can't affact the trouble face; Contain the Camphora of excessive concentrations in the five, the 95% alcoholic acid Camphora saturated solution, can cause strong stimulation, be unsuitable for dermatologic to skin.

Summary of the invention

In order to overcome the defective of above-mentioned camphor liniment, the purpose of this invention is to provide a kind of Camphora spray that can effectively eliminate the initial stage red swelling of the skin that skin swelling and pain, especially diabetes cause.Another object of the present invention provides this Camphora spray preparing process.A further object of the invention provides the goods that contain this Camphora spray.

For realizing this purpose, the invention provides a kind of Camphora spray that is used to eliminate skin swelling and pain, this Camphora spray is that Camphora and 95% (volume ratio) alcoholic solution of 30%-50% (w/v) is formed by final concentration basically.

In a preferable embodiment, the final concentration of described Camphora is 40%-50% (w/v).More preferably, the final concentration of described Camphora is 50% (w/v).

In this manual, unless refer in particular in addition, the Camphora percent concentration is all represented mass/volume percentage ratio, for example, contains 500mg Camphora in the 1000ml pharmaceutical preparation that 50% (w/v) expression makes.The concentration of alcoholic solution represents the percent by volume of water with ethanol, and for example 95% (volume ratio) represents that the ethanol in this alcoholic solution and the volume ratio of water are 19: 1, i.e. V _Ethanol: V _Water=19: 1.

Term in the description " basically by ... form " be meant, in the Camphora spray of the present invention except containing above-mentioned necessary component, also can contain some to the helper component that the characteristic and the drug effect of Camphora spray do not influence in fact, comprise wetting agent, spice, wetting agent, solubilizing agents for drugs, transdermal enhancer, surfactant, antiseptic etc.For example, the applicant finds through a series of tests, also can add a small amount of other solvent, for example propylene glycol, glycerol (wetting agent), tween (solubilizing agent), apple essence, Mentholum (spice) etc. in this Camphora spray.As long as the adding and the addition thereof of these materials can not produce a very large impact the concentration of Camphora.The selection of above-mentioned auxiliary element is known for those skilled in the art, can select with reference to various countries' pharmacopeia and numerous public publication according to the performance of the medicine that will obtain, for example referring to " pharmaceutical necessities complete works " (Luo Mingsheng, Gao Tianhui chief editor Sichuan science tech publishing house version in January nineteen ninety-five) book.In addition, consider that described solvent also should have volatility, to characteristics such as skin nonirritants from the angle of topical agent.The content of these auxiliary elements should be between 0-5% (w/v), and is better between 0-2% (w/v).

Another object of the present invention provides a kind of method for preparing above-mentioned Camphora spray, it is that the ratio of 30-50% (w/v) is dissolved in the alcoholic solution of 95% (volume ratio) Camphora that this method comprises according to the Camphora final concentration, is divided in then in the drug packages container that has quantitative atomizing pump.

In a preferable embodiment, make that the Camphora final concentration is 50% (w/v) in the alcoholic solution that is dissolved in 95% (volume ratio).

For example, take by weighing Gum Camphor 300-500g, the alcoholic solution that adds 95% (volume ratio) is to 950ml, film envelope (to prevent the ethanol volatilization), stirring and dissolving after-filtration, the alcoholic solution that adds 95% (volume ratio) at last is settled to 1000ml, the medicament for preparing is sub-packed in makes the Camphora spray in the plastic containers that have quantitative atomizing pump.The Camphora spray that makes need seal preservation.

Yet the present invention is not limited to above-mentioned concrete grammar and concrete steps.Those skilled in the art can be changed the condition of each step within the scope of the present invention, also can adopt other method of knowing to prepare Camphora spray of the present invention.

The Camphora spray that makes as stated above can be used for eliminating skin swelling and pain, especially can be used for treating the initial stage red swelling of the skin that diabetes cause.

Another object of the present invention provides a kind of goods, and it comprises:

A) have the drug packages container of quantitative atomizing pump, described container contains the above-mentioned Camphora spray of the present invention; With

B) package insert or label have provided the explanation of eliminating skin swelling and pain with described Camphora spray on described package insert or the label.

Drug packages container of the present invention comprises quantitative atomizing pump and container (for example conventional be threaded and in the chimeric cylindricality drug packages container of quantitative atomizing pump).It is the well-known conventional drug packing materials of those skilled in the art.Wherein, preferable quantitative atomizing pump is the atomizing pump of special be inverted spraying, all can spray when container is just being put or is being inverted, and more is applicable to the administration of human body bottom, and this particularly needs under the initial stage red swelling of the skin symptom situation that diabetes cause.Quantitatively atomizing pump is made up of protective cover, fog-spray nozzle, integrated nebulizer, basic pump, packing ring, threaded cap and suction pipe, and wherein basic pump comprises push rod, sealing ring, piston rod, piston, the pump housing, spring and steel ball composition.The quantitative atomizing pump specification that is adopted can be selected different bottleneck diameters and every spray amount according to different administration requirements.

The medicament that the present invention's preparation is obtained is sub-packed in the container such as plastics spray bottle that has quantitative atomizing pump, has just obtained Camphora spray product of the present invention.By adopting quantitative spraying that body surface is suffered from the face administration, can carry out topical therapeutic, also can be applied to whole body therapeutic, compared with liniment of the prior art that dosage is little, convenient drug administration evenly, the bioavailability advantages of higher.

Compare with above-mentioned prior art, Camphora spray of the present invention has overcome defective wherein, by the mass percentage content of definite main pharmacodynamics composition-Camphora, thereby makes the dosage that can monitor main pharmaceutical compositions in process of production effectively; The medicament that makes by the present invention can not separated out Camphora owing to ambient temperature and physical vibration; The present invention adopts the solvent of the alcoholic solution of 95% (volume ratio) as the effective pharmaceutical compositions of dissolving, and under this concentration, the dissolubility of Camphora is bigger, can bring into play the optimum medicine efficacy of Camphora, and the Camphora spray of 50% (w/v) detumescence effect is the most effective.Because the present invention has determined the suitable content of active drug part Camphora and has combined the spray dosage form that can bring into play drug effect, thereby made that this medicinal usage is brought into play more fully.Other advantage of the present invention and purpose also can be from hereinafter clearly learning the specific embodiments.

Specific embodiments

To the present invention be described in further detail according to following non-restrictive example and test below.

Embodiment 1

Take by weighing Gum Camphor 245,300,350,400 and 500 grams respectively, at room temperature, the alcoholic solution that adds 95% (volume ratio) is to 950ml, film envelope (to prevent the ethanol volatilization), stirring and dissolving after-filtration, the alcoholic solution that adds 95% (volume ratio) at last is settled to 1000ml, making the Camphora final concentration respectively is the Camphora medicament of 24.5% (w/v), 30% (w/v), 35% (w/v), 40% (w/v) and 50% (w/v), and sealing is preserved.

Embodiment 2

To be sub-packed in by the medicament that embodiment 1 prepares in the packing container of forming by quantitative atomizing pump and plastic containers.The volume of these plastic containers is 20ml, and the bolus volume of each plastic containers of packing into is 18ml.Every spray amount of this quantitative atomizing pump is 0.12ml.

Embodiment 3

Guidance by " the clinical and preclinical study guideline compilation of new drug " (in July, 1993, Ministry of Health of the People's Republic of China's medicine card office issued) is set up animal model with swollen method of rat paw carrageenin system and the scorching method of mouse ear caused by dimethylbenzene xylene respectively, with PIYANPING (Piyanping ointment, specification is that 20g/ props up, and Sanjiu Pharmaceutical Co., Ltd produces) carry out pharmacodynamic experiment as positive control drug.Observe the Camphora spray respectively to normal, diabetic mice and normal, diabetes rat drug effect by the inductive inflammatory edema of different proinflammatory agents.

1) influence of the diameter of normal mouse auricula swelling that causes of Camphora spray xylol

Observe the influence that Camphora spray xylol causes mice auricle swelling, and compare with PIYANPING.75 of selection healthy male mice in kunming in 8～10 ages in week, body weight 31.1 ± 3.0g is divided into 5 groups at random, 15 every group, is respectively solvent control group, PIYANPING group, the large, medium and small dosage group of Camphora spray.Each group is all smeared the mouse right ear exterior feature with dimethylbenzene 40 microlitres and is caused inflammation.After 30 minutes, each is organized the mouse right ear exterior feature and smears 95% ethanol, 50 microlitres more respectively; PIYANPING 31.25mg; 50%, each 50 microlitre of 35%, 24.5% Camphora spray every 30 minutes repeat administrations once, after 2 hours are put to death mice, lay circular auricle with diameter 8mm card punch at left and right sides ear symmetry place, weigh.With left and right sides auricle weight difference as the swelling degree.The statistical method that following pharmacodynamic experiment adopts is for to carry out date processing with the one-factor analysis of variance, and data represent that with x ± s when The results of analysis of variance showed the difference significance, reuse Q check was compared in twos.The results are shown in following table 1.

Table 1 Camphora spray xylol causes influence (n=15, the x ± s) of mice auricle swelling degree

Group drug capacity or dosage swelling degree (mg)

Solvent control group 95% ethanol 50 microlitres 12.61 ± 2.43

Positive controls PIYANPING 31.25mg 12.04 ± 3.23

Be subjected to the heavy dose of group of reagent 50% Camphora spray 50 microlitres 6.69 ± 2.77 ^Cfj

Be subjected to dosage group 35% Camphora spray 50 microlitres 9.24 ± 2.54 in the reagent ^Bei

Be subjected to reagent small dose group 24.5% Camphora spray 50 microlitres 11.85 ± 3.76 ¹

B:p＜0.05, c:p＜0.01vs solvent control group; E:p＜0.05, f:p＜0.01vs PIYANPING; I:p＜0.05, the low dose of Camphora spray of j:p＜0.01vs; Dosage Camphora spray among 1:p＜0.05vs

The above results shows that solvent control group swelling degree is 12.61 ± 2.43mg; The PIYANPING group is 12.04 ± 3.23mg; But the mice auricle swelling that Camphora spray dose-dependent inhibition dimethylbenzene causes, large, medium and small dosage group swelling degree is respectively 6.69 ± 2.77, and 9.24 ± 2.54,11.85 ± 3.76mg, significant difference between each dosage group (p＜0.01, p＜0.05).Conclusion is, local topical 24.5%～50% (w/v) but the diameter of normal mouse auricula swelling that causes of Camphora spray dose-dependent inhibition dimethylbenzene.

2) influence of the diabetic mice auricle edema that causes of Camphora spray xylol

Observe the influence that Camphora spray xylol causes the diabetic mice auricle edema, and compare with PIYANPING.Select healthy male mice in kunming in 8～10 ages in week, fasting (freely drinking water) 41 hours was surveyed fasting glucose (every Mus range of blood sugar is at 12.3-27.8mmol/L) in 96 hours behind the alloxan 200mg/ kilogram of lumbar injection 2%, caused the diabetic mice model.Select 75 of qualified diabetic mices, random packet is measured with quadrat method by above-mentioned, the results are shown in following table 2.

Table 2 Camphora spray xylol causes influence (n=15, the x ± s) of diabetic mice auricle swelling degree

Group drug capacity or dosage swelling degree (mg)

Solvent control group 95% ethanol 50 microlitres 12.36 ± 2.49

Positive controls PIYANPING 31.25mg 9.73 ± 2.80 ^a

Be subjected to the heavy dose of group of reagent 50% Camphora spray 50 microlitres 6.74 ± 2.81 ^Bc

Be subjected to dosage group 35% Camphora spray 50 microlitres 9.59 ± 2.75 in the reagent ^Ad

Be subjected to reagent small dose group 24.5% Camphora spray 50 microlitres 10.59 ± 2.86 ^d

A:p＜0.05, b:p＜0.01vs solvent control group; C:p＜0.05, the vs PIYANPING;

The heavy dose of Camphora spray of d:p＜0.01vs;

The above results shows that solvent control group swelling degree is 12.36 ± 2.49mg; The PIYANPING group is 9.73 ± 2.80mg; Show that PIYANPING can suppress the diabetic mice auricle edema that dimethylbenzene causes.But and the diabetic mice auricle edema that Camphora spray dose-dependent inhibition dimethylbenzene causes, large, medium and small dosage group swelling degree is respectively 6.74 ± 2.81, and 9.59 ± 2.75,10.59 ± 2.86mg, significant difference between each dosage group (p＜0.01, p＜0.05).Can know thus, but the diabetic mice auricle edema that local topical 24.5%～50% Camphora spray dose-dependent inhibition dimethylbenzene causes.

3) Camphora spray on Carrageenan causes the influence of normal rat pedal swelling

Observe the influence that local topical Camphora spray on Carrageenan causes the normal rat pedal swelling, and with Piyanping ointment as positive control drug.Select 60 of healthy male Wistar rats (8～12 age in week), body weight 268 ± 38g is divided into 5 groups at random, every group 12, be respectively matched group, PIYANPING group, the large, medium and small dosage group of Camphora spray, measure rat right hind leg foot sole of the foot volume, for causing scorching front foot sole of the foot volume.Behind rat right hind leg foot plantar subcutaneous injection 1.2% carrageenin (0.1ml/ only), successively at rat right hind leg foot sole of the foot local topical 95% ethanol, Piyanping ointment, 35% Camphora spray, 24.5% Camphora spray and 17.5% Camphora spray, smear dosage except that PIYANPING group rat is that the volume that all the other 4 groups of rats are smeared at every turn is 200 microlitre/foots the 0.125g/ foot at every turn.Every 1 hour local topical medicine 1 time, totally 6 times.The 2nd, 3, smear for 4,5,6 times before the medicine and smear medicine for the 6th time after respectively measured rat right hind leg foot sole of the foot volume once in 1 hour, be followed successively by and cause scorching back 1,2,3,4,5,6 hours sufficient sole of the foot volume calculates each time point pedal swelling rate.The results are shown in following table 3.

Table 3. Camphora spray (CR) on Carrageenan causes normally

The influence of rat paw edema rate (%) (n=12, x ± s)

Medicine # dosage with carrageenin after the time (hour)

μ l foot ^-1Inferior ^-1123456

17.5％CR 200 24.2±7.5 42.2±16.0 ^b 61.5±17.6 ^be?70.4±22.8 ^ac?71.7±19.1 ^bd?72.2±16.9 ^bd

24.5％CR 200 24.4±10.7 49.0±19.7 ^b 57.1±21.8 ^be?66.6±18.5 ^bc?69.2±19.6 ^bd?68.3±19.2 ^bd

35.0％CR 200 24.9±9.3 62.4±12.7 ^ac?77.8±12.3 ^d 74.4±13.0 ^ac?67.8±11.3 ^bd?65.6±13.7 ^bd

PIYANPING 0.125g 17.3 ± 8.5 46.2 ± 18.5 ^b52.0 ± 21.2 ^b50.0 ± 23.5 ^b40.3 ± 17.2 ^b34.8 ± 17.4 ^b

Matched group ^*200 29.7 ± 11.9 77.6 ± 16.6 87.9 ± 15.7 92.0 ± 14.2 91.9 ± 15.7 92.0 ± 13.6

A:p＜0.05, b:p＜0.01vs matched group; C:p＜0.05, d:p＜0.01vs PIYANPING group; E:p＜0.05vs 35% Camphora spray.

#: per hour the partial smearing medicine is 1 time, totally 6 times.*: with 95% ethanol partial smearing.

The result shows, the local topical Piyanping ointment, and the 0.125g/ foot/time, per hour 1 time, continuous 6 times, can obviously reduce the rat paw edema rate, this acts on beginning in 2 hours after the medication, lasts till after the medication more than 6 hours rat paw edema rate and matched group comparison significant difference (p＜0.01).Local topical 17.5%～35% Camphora spray, 200 microlitre/foots/time, per hour 1 time, continuous 6 times, all can obviously reduce the rat paw edema percentage rate, this acts on beginning in 2 hours after the medication, lasts till after the medication more than 6 hours, compare significant difference (p＜0.05, p＜0.01) with matched group.Results suggest: local topical 17.5%～35% Camphora spray, 200 microlitre/foots/time, the normal rat pedal swelling that on Carrageenan causes has the obvious suppression effect.

4) Camphora spray on Carrageenan causes the influence of hyperglycemic rat pedal swelling

Observe the influence that local topical Camphora spray on Carrageenan causes the hyperglycemic rat pedal swelling, and with Piyanping ointment as positive control drug.Healthy male Wistar rat (8～12 age in week), lumbar injection 1.1% streptozotocin 5ml/kg (55mg/kg), 2～3 weeks back survey blood glucose.Select 60 of the rats that blood glucose surpasses 10mmolL-1 (180mg/dL), body weight 213.8 ± 34.6g is divided into 5 groups at random, 12 every group, measures and provide the result by above-mentioned with quadrat method.

Table 4. Camphora spray (CR) on Carrageenan causes diabetes

The influence of rat paw edema rate (%) (n=12, ± s)

Medicine # dosage with carrageenin after the time (hour)

μ l foot ^-1Inferior ^-1123456

17.5％CR 200 20.5±11.8 57.4±17.2 76.3±16.7 88.7±11.9 ^df 80.5±12.1 ^bdf 82.1±9.7 ^dfg

24.5％CR 200 17.2±8.5 43.8±19.3 59.8±24.3 60.4±21.6 ^b 56.6±19.0 ^b 55.7±17.5 ^b35.0％CR

200 28.0±10.4 ^c?60.4±12.0 74.4±9.2 ^c?75.6±9.2 ^de 69.0±7.6 ^bc 61.8±8.7 ^b

PIYANPING 0.125g 13.6 ± 7.0 ^a41.0 ± 23.4 53.4 ± 18.8 ^a52.0 ± 13.1 ^b52.1 ± 10.1 ^b52.7 ± 15.5 ^b

Matched group ^*200 28.4 ± 15.5 53.6 ± 23.9 75.7 ± 27.7 90.4 ± 26.1 98.8 ± 23.6 90.9 ± 24.9

A:p＜0.05, b:p＜0.01vs matched group; C:p＜0.05, d:p＜0.01vs PIYANPING group; E:p＜0.05, f:p＜0.01vs 24.5%CR; G:p＜0.01vs 35%CR.#: per hour the partial smearing medicine is 1 time, totally 6 times.*: with 95% ethanol partial smearing.

The result shows: the local topical Piyanping ointment, 0.125g/ foot/time, per hour 1 time, continuous 6 times, can obviously reduce the rat paw edema rate, this act on after the medication 4～6 hours fairly obvious, after medication 2 hours, rat paw edema rate and matched group be the equal significance of difference (p＜0.05, p＜0.01, table 4) relatively.Local topical 24.5%～35% Camphora spray, 200 microlitre/foots/time, per hour 1 time, continuous 6 times, can obviously reduce the rat paw edema rate, 4～6 hours rat paw edema rates and matched group difference significance (p＜0.01, table 4) relatively after medication; But the effect of heavy dose of group than in the dosage group slightly a little less than, 4 hours difference significances (p＜0.05) after the medication; The effect of 24.5% Camphora spray and PIYANPING group be difference nonsignificance (p＞0.05) relatively.And local topical 17.5% Camphora spray, 200 microlitre/foots/time, per hour 1 time, continuous 6 times, the rat paw edema percentage rate is influenced not quite, only 5 hours and matched group comparison significant difference (p＜0.01, table 4) after medication.Results suggest: local topical 24.5%～35% Camphora spray, 200 microlitre/foots/time, the diabetes rat pedal swelling that on Carrageenan causes has the obvious suppression effect.

Above pharmacodynamic experiment result shows, inductive normal rat of Camphora spray on Carrageenan and diabetes rat foot sole of the foot edema, normal and diabetic mice auricle edema all has inhibitory action in various degree due to the dimethylbenzene, and it is obvious wherein the effect of diabetic animal edema to be suppressed effect.

5) adopt and above test 1) and test 2) in same procedure, the drug effect of 55% the Camphora spray that mensuration and 30-50% spray more of the present invention and blank group, camphor liniment (70% alcohol saturated solution), camphor liniment (95% alcohol saturated solution) and concentration are higher.The results are shown in following table 5.

Table 5 Camphora spray and camphor liniment pharmacodynamic experiment result comparison (n=15, x ± s)

Drug capacity or the normal mouse diabetic mice that swells

Dosage expansibility (mg) swelling degree (mg)

Blank group (not administration) 50 microlitres 12.16 ± 3.47 12.91 ± 2.08

55% Camphora spray, 50 microlitres 10.21 ± 1.81 ^b11.57 ± 2.86 ^d

50% Camphora spray, 50 microlitres 7.95 ± 1.45 ^a7.10 ± 2.64 ^a

40% Camphora spray, 50 microlitres 9.16 ± 3.63 ^c9.17 ± 2.80 ^a

30% Camphora spray, 50 microlitres 9.54 ± 1.93 ^c10.85 ± 2.92 ^c

Camphor liniment (70% alcohol saturated solution) 50 microlitres 10.00 ± 3.91 ^d10.75 ± 2.48 ^c

Camphor liniment (95% alcohol saturated solution) 50 microlitres 11.14 ± 3.00 ^d11.42 ± 2.93 ^c

a：p＜0.01；b：p＞0.05；c：p＜0.05；d：p＞0.1

As can be seen from Table 5, the skin turgor that the Camphora spray of 30%-50% and blank group compare normal and diabetic mice has significant inhibition effect (p＜0.05, p＜0.01), wherein, 50% Camphora spray is compared with camphor liniment also remarkable difference on pharmacodynamics; Though and camphor liniment compares with the blank group and have any different, and is not remarkable; 55% Camphora spray is owing to contain the Camphora of excessive concentrations, and it is very unstable that its chemical property becomes, and it is remarkable like that the result causes its drug effect to can not show a candle to the Camphora spray of 30-50%.

From the pharmacodynamic experiment of above-mentioned Camphora spray own with camphor liniment pharmacodynamic experiment result contrast as can be seen: the present invention compares the mass/volume degree (30%-50%) of having determined main pharmacodynamics composition-Camphora with prior art, and the dosage of main pharmaceutical compositions among the present invention is monitored effectively; Simultaneously, be unsaturated solution by the medicament of this concentration preparation, to compare with background technology, Camphora can not separated out owing to ambient temperature and physical vibration.The present invention has adopted the solvent of the alcoholic solution of 95% (volume ratio) as the effective pharmaceutical compositions of dissolving.Under this concentration, the dissolubility of Camphora is bigger, can bring into play the optimum medicine efficacy of Camphora, and wherein, the most effective Camphora spray working concentration of subsiding a swelling is for containing the Camphora spray of 50% (w/v) Camphora.

Although object lesson of the present invention described above, having a bit is significantly to those skilled in the art, promptly can do various variations and change to the present invention under the premise without departing from the spirit and scope of the present invention.Therefore, claims have covered all these changes within the scope of the present invention.

Claims (8)

1. Camphora spray that is used to eliminate skin swelling and pain, it is that Camphora and 95% (volume ratio) alcoholic solution of 30%-50% (w/v) is formed by final concentration basically.

2. Camphora spray according to claim 1 is characterized in that, the final concentration of described Camphora is 40%-50% (w/v).

3. Camphora spray according to claim 1 is characterized in that, the final concentration of described Camphora is 50% (w/v).

4. Camphora spray according to claim 1 is characterized in that, the described symptom that swells and ache is the initial stage red swelling of the skin that diabetes cause.

5. method for preparing above-mentioned Camphora spray, it is characterized in that, it is that the ratio of 30-50% (w/v) is dissolved in the alcoholic solution of 95% (volume ratio) Camphora that this method comprises according to the Camphora final concentration, is divided in then in the drug packages container that has quantitative atomizing pump.

6. method according to claim 5 is characterized in that, makes that the Camphora final concentration is 50% (w/v) in the alcoholic solution that is dissolved in 95% (volume ratio).

7. goods is characterized in that it comprises:

A) have the drug packages container of quantitative atomizing pump, described container contains the described Camphora spray of claim 1; With

B) package insert or label have provided the explanation of eliminating skin swelling and pain with described Camphora spray on described package insert or the label.

8. goods according to claim 7 is characterized in that, described quantitative atomizing pump is the atomizing pump that can be inverted spraying.