Compound radix tsutsugae bark aerosol and its preparation method

Abstract

The application discloses a compound Pergularia Nitida L. aerosol and a preparation method thereof. The compound Pergularia Nitida L. aerosol comprises 4-5% of a preservative, 4-10% of a film forming agent, 30.3-46.5% of Pergularia Nitida L. extract, and 40-60% of a propellant selected from at least one of propane, butane, isobutane and dimethyl ether. The compound Pergularia Nitida L. aerosol uses the Pergularia Nitida L. extract as a fungicide, and introduces the preservative and the film forming agent to obtain a medicine liquid; the propellant plays a role of pressurizing and propelling; when the compound Pergularia Nitida L. aerosol is opened, the medicine liquid is sprayed into mist and uniformly sprayed on the surface of intact skin along with the propellant, so that the effect of killing fungi is achieved, and the intact skin is not stimulated.

Description

Technical Field

[0001] The invention belongs to the technical field of skin disease treatment, and in particular relates to a compound radix scutellariae aerosol and a preparation method thereof. Background Art

[0002] Tinea pedis and tinea manuum are the most common skin diseases caused by superficial fungi. It is prevalent worldwide and is primarily treated with topical medications. Incomplete treatment or improper medication use can easily lead to relapses. Compound Tujinpi tincture is a highly effective treatment for tinea pedis and manuum, effectively killing bacteria and relieving itching. It has demonstrated excellent therapeutic effects on fungal itching of the toes, itchy skin, tinea corporis, tinea cruris, general tinea, and various types of tinea pedis and manuum. Tujinpi, also known as Tujin root bark, is the root bark of the Pinus chinensis plant in the Pinaceae family. It has insecticidal, detoxifying, diuretic, and antipruritic properties, making it an effective treatment for skin tinea. For stubborn tinea, a decoction can be used as an external wash, providing antibacterial and antipruritic effects.

[0003] Existing compound tulsi root bark tincture is a compound preparation made from tulsi root bark and typically packaged in plastic bottles. To use, a small hole is pierced through the top of the bottle stopper with a needle before the liquid is squeezed out and applied to the affected area. This often results in uneven application and a high risk of missed applications, leading to poor efficacy. Furthermore, after opening, the liquid comes into direct contact with air, resulting in poor sealing and potential leakage, volatilization, and moisture absorption during storage. Crystallization of the active ingredients from the liquid is also common at the bottle neck, directly impacting the product's efficacy.

[0004] Therefore, there is an urgent need for a compound radix scutellariae aerosol and a preparation method thereof to solve the deficiencies of the existing technical problems. Summary of the Invention

[0005] In view of the above problems, the purpose of the present invention is to provide a compound turmeric bark aerosol and a preparation method thereof, which has good bactericidal effect, is non-irritating to intact skin, and is conducive to the concentrated action of the drug solution on the target receiving surface.

[0006] To achieve the above objectives, the first aspect of the present invention provides a compound truncatum bark aerosol, which comprises, by mass fraction, 4-5% preservative, 4-10% film-forming agent, 30.3-46.5% truncatum bark extract, and 40-60% propellant, wherein the propellant is selected from at least one of propane, butane, isobutane and dimethyl ether.

[0007] Furthermore, the propellant of the present invention is dimethyl ether. During research, the inventors of the present invention discovered that when at least one of propane and butane is used as a propellant, the compound truncatum aerosol is prone to turbidity and stratification, while when dimethyl ether is used as a propellant, the compound truncatum aerosol remains clear, transparent, and homogeneous.

[0008] Furthermore, the present invention comprises 4.5-5% of preservative, 6-10% of film-forming agent, 30.4-40.5% of iris root extract, and 45-55% of propellant.

[0009] Furthermore, the present invention includes 4.5% preservative, 10% film-forming agent, 40.5% truncatum chinense extract, and 45% propellant. This formulation creates a convergent spray pattern upon spraying, which helps the drug concentrate on the target receiving surface and enhance its bactericidal effect.

[0010] Furthermore, the preservative of the present invention is selected from at least one of benzoic acid and salicylic acid. Preferably, the preservative is selected from a mixture of benzoic acid and salicylic acid, and the mass ratio of benzoic acid to salicylic acid is 3:1.5.

[0011] Furthermore, the film-forming agent of the present invention is an acrylic polymer resin. Specifically, the acrylic polymer resin includes n-octyl cyanoacrylate.

[0012] Furthermore, the present invention comprises crushing 0.8 to 1.2 parts by weight of the radix scutellariae into a coarse powder, soaking the powder in 8.6 to 9.2 parts by weight of a solvent, and filtering out the residue to produce a radix scutellariae extract. Specifically, the solvent is selected from at least one of ethanol and water, and the soaking time is 10 to 15 days.

[0013] To achieve the above objectives, the second aspect of the present invention provides a method for preparing a compound radix scutellariae aerosol, comprising the following steps:

[0014] (1) uniformly stirring the formulated amount of the radix scutellariae extract and the preservative to obtain a first homogeneous mixed solution;

[0015] (2) adding a formulated amount of a film-forming agent to the first homogeneous mixed solution, stirring and mixing to obtain a second homogeneous mixed solution;

[0016] (3) The second homogeneous mixed liquid is placed in a container, a valve is added, the container is sealed, a formula amount of propellant is added, and an atomizing nozzle is installed to prepare the compound radix scutellariae aerosol.

[0017] Furthermore, in step (3), the container is an aluminum aerosol can with a polyethylene coating liner. The use of an aluminum aerosol can with a polyethylene coating liner allows the active ingredients of the medicinal solution to be sealed and protected from light throughout the entire use of the product, ensuring that the active ingredients of the compound kelp aerosol are not easily decomposed, which would result in a decrease in the effectiveness of the medicinal solution.

[0018] Furthermore, the valve in step (3) is a 360-degree aerosol valve. The 360-degree aerosol valve and aerosol packaging form allow the product to be used upright or inverted, making it convenient for the user to operate the product independently so that the active ingredients of the liquid medicine can be directly delivered to difficult-to-reach areas (such as the back, buttocks, etc.). By selecting the spray time and nozzle type, the spray dosage and uniformity can be effectively controlled to achieve a predictable use effect.

[0019] Compared with the prior art, the present invention has the following beneficial effects:

[0020] (1) The compound truncatum aerosol of the present invention uses the truncatum aerosol extract as a fungicide, and introduces a preservative and a film-forming agent to obtain a medicinal liquid. The propellant plays a pressurized propelling role. When the valve of the compound truncatum aerosol is opened, the medicinal liquid is sprayed into mist along with the vaporized propellant and sprayed onto the intact skin surface, achieving the effect of killing fungi. Therefore, the compound truncatum aerosol of the present invention combines the truncatum aerosol extract drug with aerosol technology, and utilizes the complete airtightness and pressure-carrying characteristics of the aerosol to avoid the product function failure caused by the leakage of the medicinal liquid, the volatilization of the solvent, and the decomposition of the active ingredient during the use of the compound truncatum aerosol, and always maintains the efficacy of the medicinal liquid. The use process of the product will not cause secondary pollution to the medicinal liquid.

[0021] (2) According to the characteristics of the extract of the Chinese angelica root bark, at least one of propane, butane, isobutane and dimethyl ether is selected as a propellant in a targeted manner. Propane, butane, isobutane and dimethyl ether can exist in the compound Chinese angelica root bark aerosol in a gaseous state and have no effect on the efficacy of the extract of the Chinese angelica root bark. Through the action of the propellant, the liquid medicine is released 360 degrees in an atomized manner under pressure, and can be sprayed softly and evenly on the entire skin surface of the affected area. The liquid medicine acts concentratedly on the target receiving surface, so that the liquid medicine quickly and evenly covers the skin surface. There will be no uneven spraying or blank coating problems in the target area, ensuring that the affected skin is fully covered with the liquid medicine and there is no irritation to the intact skin. This perfectly solves the problem of uneven liquid medicine coating and easy coating leakage in traditional products. DETAILED DESCRIPTION

[0022] In order to explain the technical content and the technical effects of the present invention in detail, the following is a further description in conjunction with the embodiments. All reagents in the examples and comparative examples can be obtained from commercial sources.

[0023] Example 1

[0024] This embodiment provides a compound scutellaria baicalensis aerosol, which includes, by mass fraction, 3% benzoic acid, 1.5% salicylic acid, 10% n-octyl cyanoacrylate, 45.5% scutellaria baicalensis extract, and 40% propellant, wherein the propellant is composed of propane and butane in a mass ratio of 1:1.

[0025] This embodiment provides a method for preparing a compound radix scutellariae aerosol, the steps comprising:

[0026] (1) stirring and mixing the formulated amount of the iris extract, benzoic acid, and salicylic acid, and filtering to obtain a first homogeneous mixed solution;

[0027] (2) adding a formulated amount of n-octyl cyanoacrylate to the first homogeneous mixed solution, stirring and mixing to obtain a second homogeneous mixed solution;

[0028] (3) filling the second homogeneous mixed liquid into an aluminum aerosol can with a polyethylene coating liner, assembling and sealing the aluminum can and a 360-degree aerosol valve with a polyethylene liner, filling it with a formulated amount of a propane and butane mixture, and installing a nozzle to prepare a compound turmeric bark aerosol;

[0029] The preparation of the radix scutellariae extract comprises the following steps: crushing 1 part by mass of the radix scutellariae into coarse powder, adding 9 parts by mass of 75% alcohol, soaking for 15 days, filtering and removing residue to prepare the radix scutellariae extract.

[0030] Example 2

[0031] This embodiment provides a compound scutellaria baicalensis aerosol, which includes, by mass fraction, 3% benzoic acid, 1.5% salicylic acid, 5% n-octyl cyanoacrylate, 30.5% scutellaria baicalensis extract, and 60% propellant, wherein the propellant is composed of propane and butane in a mass ratio of 1:1.

[0032] This embodiment provides a method for preparing a compound radix scutellariae aerosol, the steps comprising:

[0033] (1) stirring and mixing the formulated amount of the iris extract, benzoic acid, and salicylic acid, and filtering to obtain a first homogeneous mixed solution;

[0034] (2) adding a formulated amount of n-octyl cyanoacrylate to the first homogeneous mixed solution, stirring and mixing to obtain a second homogeneous mixed solution;

[0035] (3) filling the second homogeneous mixed liquid into an aluminum aerosol can with a polyethylene coating liner, assembling and sealing the aluminum can and a 360-degree aerosol valve with a polyethylene liner, filling it with a formulated amount of a propane and butane mixture, and installing a nozzle to prepare a compound turmeric bark aerosol;

[0036] The preparation of the radix scutellariae extract comprises: crushing 1.2 parts by mass of the radix scutellariae into coarse powder, adding 8.8 parts by mass of 75% alcohol, soaking for 12 days, filtering and removing residue to prepare the radix scutellariae extract.

[0037] Example 3

[0038] This embodiment provides a compound scutellaria baicalensis aerosol, which comprises, by mass fraction, 3% benzoic acid, 1.5% salicylic acid, 10% n-octyl cyanoacrylate, 40.5% scutellaria baicalensis extract, and 45% propellant, wherein the propellant is composed of propane and butane in a mass ratio of 1:1.

[0039] This embodiment provides a method for preparing a compound radix scutellariae aerosol, the steps comprising:

[0040] (1) stirring and mixing the formulated amount of the iris extract, benzoic acid, and salicylic acid, and filtering to obtain a first homogeneous mixed solution;

[0041] (2) adding a formulated amount of n-octyl cyanoacrylate to the first homogeneous mixed solution, stirring and mixing to obtain a second homogeneous mixed solution;

[0042] (3) filling the second homogeneous mixed liquid into an aluminum aerosol can with a polyethylene coating liner, assembling and sealing the aluminum can and a 360-degree aerosol valve with a polyethylene liner, filling it with a formulated amount of a propane and butane mixture, and installing a nozzle to prepare a compound turmeric bark aerosol;

[0043] The preparation of the radix scutellariae extract comprises: crushing 0.8 parts by mass of the radix scutellariae into coarse powder, adding 9.2 parts by mass of 75% alcohol, soaking for 13 days, filtering and removing residue to prepare the radix scutellariae extract.

[0044] Example 4

[0045] This embodiment provides a compound scutellaria baicalensis aerosol, which comprises, by mass fraction, 3% benzoic acid, 1.5% salicylic acid, 10% n-octyl cyanoacrylate, 40.5% scutellaria baicalensis extract, and 45% propellant, wherein the propellant is dimethyl ether.

[0046] This embodiment provides a method for preparing a compound radix scutellariae aerosol, the steps comprising:

[0047] (1) stirring and mixing the formulated amount of the iris extract, benzoic acid, and salicylic acid, and filtering to obtain a first homogeneous mixed solution;

[0048] (2) adding a formulated amount of n-octyl cyanoacrylate to the first homogeneous mixed solution, stirring and mixing to obtain a second homogeneous mixed solution;

[0049] (3) filling the second homogeneous mixed liquid into an aluminum aerosol can with a polyethylene coating liner, assembling and sealing the aluminum can and a 360-degree aerosol valve with a polyethylene liner, filling the can with a formulated amount of dimethyl ether, and installing a nozzle to prepare the compound radix scutellariae aerosol;

[0050] The preparation of the radix scutellariae extract comprises the following steps: crushing 1 part by mass of the radix scutellariae into coarse powder, adding 9 parts by mass of 75% alcohol, soaking for 15 days, filtering and removing residue to prepare the radix scutellariae extract.

[0051] Comparative Example 1

[0052] This comparative example provides a compound scutellaria baicalensis aerosol, which comprises, by mass fraction, 3% benzoic acid, 1.5% salicylic acid, 15.5% scutellaria baicalensis extract, and 80% propellant, wherein the propellant is composed of propane and butane in a mass ratio of 1:1.

[0053] This comparative example provides a method for preparing a compound radix scutellariae aerosol, comprising the following steps:

[0054] (1) stirring and mixing the formulated amount of the iris extract, benzoic acid, and salicylic acid, and filtering to obtain a first homogeneous mixed solution;

[0055] (2) filling the first homogeneous mixed liquid into an aluminum aerosol can with a polyethylene coating liner, assembling and sealing the aluminum can and a 360-degree aerosol valve with a polyethylene liner, filling the can with a formulated amount of a propane and butane mixture, and installing a nozzle to prepare a compound turmeric bark aerosol;

[0056] The preparation of the radix scutellariae extract comprises the following steps: crushing 1 part by mass of the radix scutellariae into coarse powder, adding 9 parts by mass of 75% alcohol, soaking for 15 days, filtering and removing residue to prepare the radix scutellariae extract.

[0057] Comparative Example 2

[0058] This comparative example provides a compound scutellaria baicalensis aerosol, which comprises, by mass%, 3% benzoic acid, 1.5% salicylic acid, 5% n-octyl cyanoacrylate, 10.5% scutellaria baicalensis extract, and 80% propellant, wherein the propellant is dimethyl ether.

[0059] This comparative example provides a method for preparing a compound radix scutellariae aerosol, comprising the following steps:

[0060] (1) stirring and mixing the formulated amount of the iris extract, benzoic acid, and salicylic acid, and filtering to obtain a first homogeneous mixed solution;

[0061] (2) adding a formulated amount of n-octyl cyanoacrylate to the first homogeneous mixed solution, stirring and mixing to obtain a second homogeneous mixed solution;

[0062] (3) filling the second homogeneous mixed liquid into an aluminum aerosol can with a polyethylene coating liner, assembling and sealing the aluminum can and a 360-degree aerosol valve with a polyethylene liner, filling the can with a formulated amount of dimethyl ether, and installing a nozzle to prepare the compound radix scutellariae aerosol;

[0063] The preparation of the radix scutellariae extract comprises the following steps: crushing 1 part by mass of the radix scutellariae into coarse powder, adding 9 parts by mass of 75% alcohol, soaking for 15 days, filtering and removing residue to prepare the radix scutellariae extract.

[0064] The compound Pergularia roxburghiii aerosol of Examples 1-4 and Comparative Examples 1-2 and existing tinea agent preparations were subjected to bactericidal effect test, and the test was divided into 8 groups, namely, Examples 1, 2, 3, 4, Comparative Examples 1, 2, 3 (tinea agent preparations), and a blank control group (sterile normal saline). The culture medium was Sabouraud glucose agar, and two common skin tinea-causing fungi, Trichophyton mentagrophytes and T. tonsurans, were selected as test strains. The test was carried out in the manner of carrier spraying quantitative bactericidal test, the action time was 5 min, and the test method referred to the second part (2.1.1.9) of the Disinfection Technical Standard (Ministry of Health, 2002 edition). Among them, the killing of microorganisms with a logarithmic value of ≥6.00 was evaluated as excellent; the killing of microorganisms with a logarithmic value of ≥5.00 but less than 6.00 was evaluated as good; and the killing of microorganisms with a logarithmic value of ≥4.00 but less than 5.00 was evaluated as general. The bactericidal effect test results are shown in Table 1.

[0065] The compound Pergularia roxburghiii aerosol of Examples 1-4 and Comparative Examples 1-2 and existing tinea agent preparations were subjected to one-time complete skin irritation test. Specifically, about 24 h before the test, the fur on both sides of the dorsal spine of New Zealand rabbits was shaved, without damaging the epidermis, and the shaved area was about 3 cm*3 cm on the left and right. The product was sprayed on the left shaved skin with an area of 2.5 cm*2.5 cm according to the usage method, then covered with two layers of gauze and one layer of plastic film, and fixed with non-irritating adhesive tape. The other side of the skin served as a control. After 4 h of action, the test substance was removed with warm water. The skin reaction was observed 24 h after the removal of the test substance, and the score was made according to Table 2-11 of the Disinfection Technical Standard (2002 edition). Three animals were used for each sample, and the skin irritation intensity was graded according to Table 2-12 of the Disinfection Technical Standard (2002 edition) at the end of the experiment. The results of the one-time complete skin irritation test are shown in Table 2.

[0066] The compound Pergularia roxburghii aerosol of Examples 1-4 and Comparative Examples 1-2 and existing tinea agent preparations were subjected to drug film concentration covering test. Specifically, a) the sample was taken, the AE7-60M nozzle was installed, and the spraying method indicated by the sample was used to exclude the propellant or air remaining in the valve and / or suction pipe during filling operation; b) the sample was placed in a 25℃ constant temperature water bath, the water was immersed in the can body, and the constant temperature was maintained for 30 min; c) the sample was taken out and dried. Except for the samples that were not allowed to shake the can body, the samples were shaken six times; d) the sample was positioned so that the nozzle was aimed at the kraft paper, and the nozzle and the center of the kraft paper were on the same horizontal line. The nozzle was pressed for 3 s to spray, and the width of the spray shape on the kraft paper was measured. A width of not more than 4 cm was excellent; a width of more than 4 cm but not more than 5 cm was good; a width of more than 5 cm but not more than 7 cm was general; and a width of more than 7 cm was poor. The test results are shown in Table 3.

[0067] Table 1 Bactericidal effect test results

[0068]

[0069] Table 2 Results of one-time intact skin irritation test

[0070]

[0071] Table 3 Results of concentrated coverage test of drug film

[0072]

[0073]

[0074] As shown in Tables 1 to 3, the compound tulsi cortex aerosols of Examples 1 to 4 have good bactericidal effects and are non-irritating to intact skin. This indicates that the compound tulsi cortex aerosols prepared using 4-5% preservatives, 4-10% film-forming agents, 30.3-46.5% tulsi cortex extract, and 40-60% propellants as raw materials have good bactericidal effects, are non-irritating to the skin, and are conducive to the concentrated action of the drug solution on the target drug-receiving surface. At the same time, by comparing Examples 2 to 3 with Comparative Examples 1 to 2, it can be seen that adjusting the content of the film-forming agent, the content of the high propellant, and the content of the tulsi cortex extract will cause an irritating reaction to the skin, and is also not conducive to the concentrated action of the drug solution on the target drug-receiving surface. This also shows that the present invention achieves a synergistic effect by rationally combining multiple components, that is, changes in the components and contents will cause an irritating reaction to the intact skin, and are also not conducive to the concentrated action of the drug solution on the target drug-receiving surface.

[0075] It can be seen from Table 3 that, compared with Examples 1 to 3, the spray shape formed by the compound tulsi cortex aerosol of Example 4 is the most convergent (the mist width is not more than 4 cm), which is conducive to the concentrated action of the drug solution on the target drug-receiving surface, helping to exert the bactericidal effect of the drug solution. At the same time, combined with Table 1, it can be seen that Example 4 has the best bactericidal effect, which also shows that the present invention preferably uses 4.5% preservative, 10% film-forming agent, 40.5% tulsi cortex extract, and 45% propellant as raw materials to obtain a compound tulsi cortex aerosol with the best bactericidal effect and no irritation to intact skin.

[0076] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit the scope of protection of the present invention. Although the present invention has been described in detail with reference to preferred embodiments, those skilled in the art should understand that the technical solutions of the present invention may be modified or replaced by equivalents without departing from the essence and scope of the technical solutions of the present invention.

Claims

1. A compound radix scutellariae aerosol, characterized in that: Calculated by mass, the preparation comprises 4.5% preservative, 10% film-forming agent, 40.5% iris root extract, and 45% propellant, wherein the propellant is dimethyl ether.

2. The compound tsutsuga chinensis aerosol according to claim 1, characterized in that The preservative is selected from at least one of benzoic acid and salicylic acid.

3. The compound tsutsuga chinensis aerosol according to claim 1, characterized in that The film-forming agent is an acrylic polymer resin.

4. The compound tsuruha bark aerosol according to claim 1, characterized in that The method comprises the steps of crushing 0.8 to 1.2 parts by mass of the radix scutellariae into coarse powder, soaking the powder in 8.6 to 9.2 parts by mass of a solvent, and filtering and removing residue to prepare the radix scutellariae extract.

5. A method for preparing the compound truncatum aerosol according to any one of claims 1 to 4, characterized in that the steps include: (1) Stirring the formulated amount of the radix scutellariae extract and the preservative to obtain a first homogeneous mixed solution; (2) adding a formulated amount of film-forming agent to the first homogeneous mixed solution, stirring and mixing to obtain a second homogeneous mixed solution; (3) The second homogeneous mixed liquid is placed in a container, a valve is added, the container is sealed, a formula amount of propellant is added, and an atomizing nozzle is installed to prepare the compound radix scutellariae aerosol.

6. The method for preparing the compound truncatum chinense aerosol according to claim 5, wherein: The container in step (3) is an aluminum aerosol can with a polyethylene coating liner.

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