WO2004041261A1 - A kind of camphor spray and its preparation and a product containing it - Google Patents

Abstract

The invention provides a camphor spray used for eliminating gall, which essentially consists of 30-50% (w/v) camphor and 95% (volume) alcohol solution. The invention also provides preparation methods of the spray and products containing the preparation. The camphor spray of the invention is effective and it can be carried conveniently. It can be used for treating skin gall, specially used for treating initial skin rubor and swelling results from diabete.

Description

 Camphor spray and preparation method and product thereof

 The present invention relates to the field of medicine, and in particular to a camphor spray for eliminating skin swelling and pain, a preparation method and a product thereof. Background technique

 So far, various schemes have been proposed as a camphor-containing external medicine for swelling and analgesia.

 Chinese Patent Application No. 99119811.5 discloses a topical camphor tincture for eliminating skin swelling and pain. The tincture is a saturated solution of camphor dissolved in 70% -95% ethanol. The manufacturing method of the camphor tincture is as follows: The refined purified camphor is dissolved in 70% -95% ethanol to a saturated concentration, and then sealed and stored. At 31 ° C, 91.5 g of purified camphor was dissolved in 50 ml of ethanol / water (V ethanol: V water = 19: 1) solution, with a final volume of 145 ml to make a camphor-95% saturated alcohol solution; 68.0 g of refined Camphor is dissolved in 50 ml of ethanol / water (V ethanol: V water = 9: 1) solution with a final volume of 118 ml to make a camphor-90% saturated alcohol solution; 31.2 g of refined camphor is dissolved in 50 ml of ethanol / water (V: V = 7: 3) In the solution, the final volume is 64 ml to make a camphor-70% saturated alcohol solution. The camphor tincture can be used to treat sores, boils, skin infections mainly caused by unknown causes, unknown swelling and poison caused by temperature stimulation, and redness and swelling of the lower extremity skin caused by diabetes. Its pharmacology is: camphor increases the permeability of the blood vessels in the affected area, so that the histamine content inside and outside the cell is balanced, so as to achieve the effect of swelling. .

However, the technical solution disclosed in this patent application has poor implementation results due to the following shortcomings: First of all, in the preparation process of the camphor tincture, the preparation temperature is required to be 31 ° C, which will cause ethanol. The large amount of solution volatilized makes it difficult for camphor to dissolve completely in 95% ethanol solution under the condition of determining the unit volume. Compared with the expected concentration, the error is large, so it cannot achieve the desired effect. Second, during the preparation of the camphor agent In addition, because only the concentration of the ethanol solution was determined, the concentration of the effective pharmaceutical ingredient, camphor, was not determined (that is, the formulation standard was limited to the saturated solution of ethanol), and the content of camphor in the saturated solution depended on the preparation temperature and mechanical vibration. Factors such as camphor in the solution cannot be accurately quantified. Third, when the tincture is applied to the surface of the skin, because the ethanol is very volatile, the camphor in the saturated solution quickly precipitates out as a powder and covers it. The surface of the skin, so that the drug cannot evenly affect the affected area of the skin; fourth, The amount of liquid medicine of this tincture is not easy to grasp, and it will flow around, often making the medicine unable to act on the affected surface. Fifth, the 95% ethanol-saturated camphor solution contains excessively high concentration of camphor, which will cause skin damage. Causes excessive irritation and is not suitable for skin medication. Summary of the invention,

 In order to overcome the defects of the camphor tincture described above, an object of the present invention is to provide a camphor spray which can effectively eliminate skin swelling and pain, especially the initial skin redness caused by diabetes. Another object of the present invention is to provide a method for preparing the camphor spray. It is another object of the present invention to provide an article containing the camphor spray.

 To achieve this, the present invention provides a camphor spray for eliminating skin swelling. The camphor spray basically consists of camphor with a final concentration of 30% -50% (w / v) and 95% (volume ratio). ) Composition of ethanol solution.

 In a preferred embodiment, the final concentration of camphor is 40% -50% (w / v). Even more preferably, the final concentration of camphor is 50% (w / v). ―

In the present specification, unless otherwise specified, the percentages are expressed by mass camphor concentration / volume percentage, e.g., 50% (w / v) indicates a pharmaceutical formulation prepared 1000ml containing 500m _g camphor. The concentration of the ethanol solution is expressed by the volume percentage of ethanol to water. For example, 95% (volume ratio) indicates that the volume ratio of ethanol to water in the ethanol solution is 19: 1, which is V ethanol: V water = 19: 1.

 The term "consisting essentially of" in the specification means that the camphor spray according to the present invention may contain, in addition to the above-mentioned essential components, some auxiliary components that do not substantially affect the characteristics and efficacy of the camphor spray Including wetting agents, fragrances, humectants, drug solubilizers, transdermal enhancers, surfactants, preservatives, etc. For example, the applicant has found through a series of experiments that a small amount of other solvents can be added to the camphor spray, such as propylene glycol, glycerin (humectant), Tween (solubilizer), apple flavor, menthol (fragrance), and the like. As long as the addition of these substances and the amount of addition do not have a great effect on the concentration of camphor. The selection of the above-mentioned auxiliary ingredients is well known to those skilled in the art, and can be selected by referring to the pharmacopoeia of various countries according to the properties of the drug to be obtained and published in a large number of public publications. Press, January 1995). In addition, from the point of view of external agents, the solvent should also have characteristics such as volatility and no irritation to the skin. The content of these auxiliary components should be between 0-5% (w / v), and more preferably between 0-2% (w / v). '

Another object of the present invention is to provide a method for preparing the above camphor spray, which method comprises dissolving camphor in a 95% (volume ratio) ethanol solution according to the final camphor concentration of 30-50% ( _W A), and then Dispensed in a drug packaging container with a metered spray pump.

 In a preferred embodiment, the final camphor concentration is 50% (w / v) dissolved in a 95% (volume) ethanol solution.

For example, weigh 300-500g of refined camphor, add 95% (volume ratio) ethanol solution to 950ml, and seal (to (To prevent ethanol from being volatilized), stir and dissolve the filter, and finally add 95% (volume ratio) ethanol solution to make up to 1000ml. Dispense the prepared medicine into a plastic container with a quantitative spray pump to make a camphor spray. The prepared camphor spray needs to be kept sealed.

 However, the present invention is not limited to the specific methods and specific steps described above. Those skilled in the art can modify the conditions of each step within the scope of the present invention, and can also use other well-known methods to formulate the camphor spray of the present invention.

 The camphor spray prepared according to the above method can be used to eliminate skin swelling and pain, and especially can be used to treat the initial skin redness caused by diabetes. '

 Another object of the present invention is to provide an article of manufacture comprising:

 a) a pharmaceutical packaging container with a quantitative spray pump, said container containing the camphor spray of the present invention; and

 A package insert or label on which instructions for using the camphor spray to eliminate swelling and pain in the skin is given.

 The medicine packaging container according to the present invention includes a quantitative spray pump and a container (e.g., a cylindrical drug packaging container conventionally threaded and fitted with the quantitative spray pump). It is a conventional pharmaceutical packaging material well known to those skilled in the art. Among them, the preferred quantitative spray pump is a special spray pump that can be sprayed upside down. It can spray when the container is upside down or upside down, and it is more suitable for lower body administration. This is especially needed in the case of initial skin redness caused by diabetes . The quantitative spray pump consists of a protective cover, a spray head, an integrated atomizer, a basic pump, a gasket, a screw cap and a suction tube. The basic pump includes a push rod, a seal ring, a piston rod, a piston, a pump body, a spring, and a steel ball. The specifications of the quantitative spray pump used can be selected according to different dosing requirements, different bottle mouth diameters and sprays, and the medicament prepared by the present invention is dispensed in a container with a quantitative spray pump, such as a plastic spray bottle. A camphor spray product according to the invention is obtained. Compared with the tinctures in the prior art, it has a small amount of useful medicine, convenient and uniform administration, and high bioavailability, etc. advantage.

Compared with the aforementioned prior art, the camphor spray of the present invention overcomes the defects therein. By determining the mass percentage content of the main medicinal ingredient, camphor, so that the dosage of the main medicinal ingredient can be effectively monitored during the production process; The medicament prepared by the present invention does not precipitate camphor due to external temperature and physical vibration; the present invention uses a 95% (volume ratio) ethanol solution as a solvent for dissolving effective pharmaceutical ingredients. At this concentration, the solubility of camphor is relatively large. Can exert the best medicinal effect of camphor, and the 50% (w / v) camphor spray has the most effective swelling reduction effect. Since the present invention determines a suitable content of effective camphor and combines it with a spray formulation capable of exerting a medicinal effect, from And make the use of the drug more fully. Other advantages and objects of the present invention can be clearly understood from the following specific embodiments. Specific implementation plan

 The present invention will be further described in detail based on the following non-limiting examples and tests.

 Example 1

 Weigh 245, 300, 350, 400, and 500 grams of refined camphor, add 95% (volume ratio) ethanol solution to 950ml at room temperature, seal with membrane (to prevent ethanol from volatilizing), stir and dissolve, and then add 95 % (Volume ratio) ethanol solution was made up to 1000ml, and the final camphor concentrations were formulated to be 24.5% (w / v), 30% (w / v), 35% (w / v), 40% (w / v) And 50% (w / v) camphor medicament, kept sealed. Example 2

 The medicament prepared in Example 1 was dispensed into a packaging container composed of a metered spray pump and a plastic container. The volume of the plastic container is 20 ml, and the volume of the medicine filled in each plastic container is 18 ml. The metered spray pump has a dosage of 0.12 ml. Example 3

 According to the "Compilation of Guiding Principles for the Clinical and Preclinical Studies of New Drugs" (issued by the Drug Certificate Bureau of the Ministry of Health of the People's Republic of China in July 1993), inflammation was induced by carrageenan in rat foot and xylene in mice An animal model was established by using Pi Yanping (Pi Yanping ointment, 20 g / branch, manufactured by Sanjiu Pharmaceutical Co., Ltd.) as a positive control drug for pharmacodynamic experiments. Observe the efficacy of camphor spray on inflammatory edema induced by different inflammatory agents in normal, diabetic mice and normal, diabetic rats.

 1) The effect of camphor spray on the swelling of the auricle of normal mice caused by xylene.

The effects of camphor spray on the swelling of the auricles of mice induced by xylene were compared and compared with that of Pi Yanping. Eighty to ten weeks, 75 healthy male Kunming mice were selected, weighing 31.1 ± 3.0g, and randomly divided into 5 groups of 15 mice each, which were the solvent control group, dermatitis group, and camphor spray large, medium, and small. Dose group. In each group, 40 microliters of xylene was applied to the right auricle of the mouse to cause inflammation. After 30 minutes, the right auricle of each group was smeared with 50 microliters of 95% ethanol; dermatitis 31.25mg _; 50 microliters of 50%, 35%, and 24.5% camphor spray, repeated administration every 30 minutes After 2 hours, the mice were sacrificed, and round ears were punched on the left and right ears symmetrically with an 8 mm diameter hole punch and weighed. The difference in weight between the left and right ear pieces was taken as the degree of swelling. The statistical method used in the following pharmacodynamic experiments is to use single-factor analysis of variance for data processing. The data is expressed as ± s. When the analysis of variance shows that the difference is significant Then, use the Q test to make a pairwise comparison. The results are shown in Table 1 below.

 Table 1.Effect of camphor spray on xylene-induced auricle swelling in mice (n

Volume or dose swelling (mg) of solvent group 95% ethanol 50 microliters in the control group 12.61 + 2.43 dermatitis flat 31.25mg positive group 12.04 + 3.23 50% camphor spray 50 6.7% + 2.77 ^{c fj} 35% camphor spray 50 μl in the test medium dose group 9.24 + 2.54 ^ei 24.5% camphor spray 50 μl in the small dose group ^ei test drug '11.85 + 3.76 ¹ b: p <0.05, c: p <0.01 vs solvent control group; e: p <0.05, f: pO.Ol vs Pi Yanping; p <0.05, j: pO.Olvs low-dose camphor spray; 1: p <0.05 vs medium-dose camphor spray

The above results show that the swelling degree of the solvent control group is 12.61 ± 2.43 mg _{; the} piyanping group is 12.04 ± 3.23 mg; the camphor spray can dose-dependently suppress the swelling of mice's auricle caused by xylene. Large, medium and small dose groups The swelling degrees were 6.69 ± 2.77, 9.24 + 2.54, 11.85 ± 3.76mg, and the differences between the dose groups were significant (p <0.01, p <0.05). It is concluded that topical application of camphor spray from 24.5% to 50% (w / v) can dose-dependently inhibit the swelling of the auricle of normal mice caused by xylene.

2) Effect of camphor spray on auricle swelling caused by xylene in diabetic mice

 The effects of camphor spray on auricle swelling induced by xylene in diabetic mice were compared and compared with that of Pi Yanping. Healthy male Kunming mice aged 8 to 10 weeks were selected, fasted (free drinking) for 41 hours, and fasting blood glucose was measured 96 hours after intraperitoneal injection of 2% tetraoxopyrimidine 200 mg / kg (the blood glucose range of each rat was 12.3-27.8 mmol / L), creating a mouse model of diabetes. A total of 75 qualified diabetic mice were selected and randomly divided into groups. The results were shown in Table 2 below.

 Table 2.Effect of camphor spray on auricle swelling in xylene-induced diabetic mice (n = 15, soil s) Group Drug Volume or dose Swelling (mg) Solvent control group 95% ethanol 50 microliters 12.36 ± 2.49

Positive control group 'dermatitis · 31.25mg 9.73 + 2.80 ^a

Test drug large dose with 50% camphor spray 50 microliters 6.74 + 2.81 ^bc

Tested Chinese medicine wanted 35% camphor spray 50 microliters 9.59 + 2.75 ^ad

Test drug small agent J Yin 24.5% camphor spray 50 microliters 10.59 ± 2.86 ^d

a: p <0.05, b: p <0.01 vs solvent control group; c: p <0.05, vs Pi Yanping; d: p <0.01 vs high-dose camphor spray;

The above results show that the swelling degree of the solvent control group is 12.36 ± 2.49 mg _{; the} piyanping group is 9.73 ± 2.80 mg _; indicating that piyanping can inhibit the auricle swelling of diabetic mice caused by xylene. The camphor spray can dose-dependently inhibit the auricle swelling of diabetic mice caused by xylene. The swelling degrees of the large, medium and small dose groups were 6.74 ± 2.81, 9.59 + 2.75, 10.59 ± 2.86mg, and the differences between the dose groups Significant (p <0:01, p <0.05). It can be known that topical application of 24.5% to 50% camphor spray can dose-dependently inhibit the auricle swelling of diabetic mice caused by xylene.

3) Effect of camphor spray on carrageenan swelling of normal rats

 To observe the effect of topical camphor spray on carrageenan-induced swelling of normal rats, and use Pi Yanping ointment as a positive control. Sixty healthy male Wistar rats (8-12 weeks old) were selected, weighing 268 ± 38g, and randomly divided into 5 groups of 12 rats each, which were the control group, dermatitis group, and camphor spray in large, medium, and small doses. Group, measure the plantar volume of the right hind limb of the rat, which is the volume of the plantar plant before inflammation. After subcutaneous injection of 1.2% carrageenan (0.1ml / head) in the right hind limb of the rat, topically apply 95% ethanol, dermatitis ointment, 35% camphor spray, and 24.5% camphor to the right hind limb of the rat. Spray and 17.5% camphor spray, except for the application of 0.125 g / foot per rat in the Piyanping group, the volume of each application in the remaining 4 groups was 200 μl / foot. Topical topical medications are administered once every 1 hour for a total of 6 times. Before the 2nd, 3rd, 4th, 5th, 6th application of the drug and 1 hour after the 6th application of the drug, measure the plantar volume of the right hind limb of the rat once, followed by 1, 2, 3, 4, 5, after the inflammation. The 6-hour plantar volume was used to calculate the plantar swelling rate at each time point. The results are listed in Table 3 below. Table 3. Camphor gel caused by camphor spray (CR) is normal

 Effect of rat foot plantar swelling rate (% :) 0 = 12, soil s)

Drug # Time after carrageenan administration (hours)

'μΐ-foot-' times- ¹ 1 2 3 4 5 6

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 ^ω 65.6 + 13.7 ^bd Dermatitis 0.125g 17.3 ± 8.5 46.2 ± 18.5 ^b 52.0 ± 21.2 ^b 50.0 ± 23.5 ^b 40.3 ± 17.2 ^b 34.8 ± 17.4 ^b control 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 <0.01 vs control group; c: p <0.05, d: p <0.01 vs piyanping group; p <0.05 vs 35% camphor spray.

 #: Apply the drug topically once an hour for a total of 6 times. *: Apply topically with 95% ethanol. The results show that topical dermatitis ping ointment, 0.125 g / foot / time, once an hour, 6 times in a row, can significantly reduce the rate of swelling of the plantar foot in rats. This effect starts 2 hours after the treatment and continues until 6 after the treatment. For more than an hour, the rate of swelling of the plantar plantar in rats was significantly different from that in the control group (p <0.01). Topical topical 17.5% ~ 35% camphor spray, 200 microliters / foot / time, 1 hour per hour, 6 consecutive times, can significantly reduce the percentage of plantar swelling in rats. This effect begins 2 hours after the administration and continues until More than 6 hours after administration, there is a significant difference compared with the control group (p <0.05, ― p <0.01 The results suggest: topical topical 17.5% ~ 35% camphor spray, 200 microliters / foot / time, caused by carrageenan Swelling of plantar plantar in normal rats has obvious inhibitory effect.

4) Effect of camphor spray on carrageenan-induced plantar swelling in hyperglycemic rats

 The effect of topical camphor spray on carrageenan-induced swelling of the plantar plantlets in hyperglycemic rats was observed, and dermatitis ping ointment was used as a positive control. Healthy male Wistar rats (8-12 weeks old) were injected intraperitoneally with '1.1% streptozotocin 5ml / kg (55mg / kg), and blood glucose was measured after 2-3 weeks. Sixty rats with blood glucose over 10 mmo (L ClSOmg / dL) were selected, weighing 213.8 ± 34.6 g, and randomly divided into 5 groups of 12 rats each. The results were determined in the same way as above. -Table 4. Diabetes caused by camphor spray (CR) carrageenan

 Effect of Foot Plank Swelling Rate (%) in Rats (n = 12, ± s)

 Drug # Time after carrageenan administration (hours)

μ1 · times- ¹ 1 2 3 4 5 6

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 ^b

35.0% CR 200 28.0 ± 10.4 ^C 60.4 ± 1 · 2.0 74.4 ± 9.2 ^C 75.6 ± 9.2 ^de 69.0 ± 7.6 ^bc 61.8 ± 8.7 ^b Dermatitis 0.125g 13.6 ± 7.0 ^a 41.0 ± 23.4 53.4 ± 18.8 ^a 52.0 ± 13.1 ^b 52.1 ± 10.1 ^b 52.7 ± 15.5 ^b control 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 <0.01 vs control group; c: p <0.05, d: p <0.01 vs. Pi Yanping group; e: p <0.05, f: p <0.01 vs 24.5% CR; g: p <0.01 vs 35% CR. #: Apply the drug topically once an hour for a total of 6 times. *: Apply topically with 95% ethanol. The results show: topical dermatitis ping ointment, 0.125 g / foot / time, once an hour, 6 times in a row, can significantly reduce the rate of swelling of the plantar plantlets in rats, this effect is very obvious 4 to 6 hours after administration, except after administration After 2 hours, the rate of swelling of the plantar plantlets in rats was significantly different from that in the control group (p <0.05, p <0.01, Table 4). Topical topical 24.5% ~ 35% camphor spray, 200 microliters / foot / time, once per hour, 6 times in a row, can significantly reduce the rate of swelling of the plantar plantlets in rats, and the swelling of the plantar plantars in rats after 4 to 6 hours after application The rate was significantly different from the control group (p <0.01, Table 4); but the effect of the high-dose group was slightly weaker than that of the middle-dose group, and the difference was significant at 4 hours (p <0.05); 24.5% camphor spray Compared with the Pi Yanping group, the effect was not significant (p> 0.05). The topical topical 17.5% camphor spray, 200 microliters / foot / time, once an hour, 6 times in a row, had little effect on the percentage of plantar swelling in rats, and it was significantly different from the control group only 5 hours after administration ( p <0.01, Table 4). The results suggest that topical application of 24.5% to 35% camphor spray, 200 microliters / foot / time, can significantly inhibit the plantar swelling caused by carrageenan in diabetic rats.

 The results of the above pharmacodynamic experiments show that camphor spray can inhibit carrageenan-induced normal plant and diabetic rat foot edema, xylene-induced normal and diabetic mouse auricle edema have different degrees of inhibition, of which It has obvious inhibitory effect on edema in diabetic animals.

5) Using the same method as in test 1) and test 2) above, determine and compare the 30-50% spray of the present invention with a blank control group, camphor tincture (70% ethanol saturated solution), and camphor tincture ( 95% ethanol saturated solution) and a high concentration of 55% camphor spray. The results are listed in Table 5 below. Table 5 Comparison of pharmacodynamic experiments of camphor spray and camphor tincture (η = 15,; ± s)

 Drugs' volume or swelling in normal mice Diabetic mice

 Dose Swell (mg) Swell (mg)

 Blank control group (without administration) 50 μl 12.16 + 3.47 12.91 + 2.08

55% camphor spray50 microliters 10.21 ± 1.81 ^b 11.57 ± 2.86 ^d

50% camphor spray 50 μl 7.95 + 1.45 ^a 7.10 ± 2.64 ^a

40% camphor spray 50 μl 9.16 ± 3.63 ^c 9.17 + 2.80 ³

50% of 30% camphor spray 9.54 ± 1.93 ^c 10.85 ± 2.92 ^c

Camphor tincture (70% ethanol saturated solution) 50 μl 10.00 ± 3.91 ^d 10.75 + 2.48 ^c

Camphor tincture (95% ethanol saturated solution :) 50 μl 11.14 + 3.00 ^d 11.42 ± 2.93 ^c a: p <0.01; b: p>0.05; c: p <0.05; d: p> 0.1 It can be seen from Table 5 that 30% -50% camphor spray has a significant inhibitory effect on skin swelling of normal and diabetic mice compared with the blank control group (p <0.05, p <0.01), of which 50% Compared with camphor 'tincture, the camphor spray also has significant differences in pharmacodynamics; while camphor tincture has a difference compared with the blank control group, but it is not significant; 55% of the camphor spray has an excessively high concentration The camphor's chemical properties have become very unstable, and as a result, its efficacy is far less significant than that of a 30-50% camphor spray. '' From the pharmacodynamic experiments of the camphor spray itself and the comparison with the results of the camphor tincture pharmacodynamic experiment, it can be seen that: compared with the prior art, the present invention determines the mass / volume percentage content (30 % -50%), so that the dosage of the main pharmaceutical ingredients in the present invention can be effectively monitored; meanwhile, the medicament formulated according to the concentration is an unsaturated solution. Compared with the background art, camphor will not be affected by external temperature and physical vibration. Precipitation. In the present invention, a 95% (volume ratio) ethanol solution is used as a solvent for dissolving effective pharmaceutical ingredients. At this concentration, the solubility of camphor is large, and the best medicinal effect of camphor can be exerted. Among them, the most effective camphor spray for swelling is a camphor spray containing 50% (w / v) camphor. Although specific examples of the present invention have been described above, it is obvious for those skilled in the art that various changes and modifications can be made to the present invention without departing from the spirit and scope of the present invention. It is therefore intended to cover in the appended claims all such changes that are within the scope of this invention.

Claims

Rights request 1. A camphor spray for eliminating skin swelling and pain, which basically consists of camphor with a final concentration of 30% -50% ( _W / v) and a 95% (volume ratio) ethanol solution.  2. The camphor spray according to claim Γ, wherein the final concentration of the camphor is 40% -50% (w / v).  3. The camphor spray according to claim 1, wherein the final concentration of the camphor is 50% (w / v).  The camphor spray according to claim 1, wherein the symptoms of swelling and pain are redness and swelling of the skin at an early stage caused by diabetes.  5. A method for preparing the above camphor spray, characterized in that the method comprises dissolving camphor in a 95% (volume ratio) ethanol solution according to a final camphor concentration of 30-50% (w / v), It is then dispensed in a drug packaging container with a metered spray pump.  6. The method according to claim 5, wherein the final camphor concentration in a 95% (volume ratio) ethanol solution is 50% (w / v).  7. An article of manufacture, comprising:  a) a pharmaceutical packaging container with a quantitative spray pump, said container containing the camphor spray of claim 1; and  b) Packaging inserts or labels, the package inserts or labels give instructions for using the camphor spray to eliminate swelling and pain in the skin.  8. The article of claim 7, wherein the metered spray pump is a spray pump that can be sprayed upside down.