A cough and asthma relieving ointment and a preparation method thereof

Abstract

This invention belongs to the technical field of external preparations of traditional Chinese medicine, and discloses a medicated ointment for relieving cough and asthma and its preparation method. The external medicated ointment comprises active medicinal components and an external matrix. The active medicinal components include a first medicinal extract made from Fritillaria cirrhosa, bitter almond, Houttuynia cordata, Salvia miltiorrhiza, and licorice, and a second medicinal powder made from Aquilaria sinensis, Asarum heterotropoides, and Acorus tatarinowii. In preparation, Fritillaria cirrhosa, bitter almond, Houttuynia cordata, Salvia miltiorrhiza, and licorice are pre-soaked in vinegar, extracted with an ethanol-water solution, and concentrated to obtain the first medicinal extract; Aquilaria sinensis, Asarum heterotropoides, and Acorus tatarinowii are dried and pulverized to obtain the second medicinal powder; the first medicinal extract is then mixed with the external matrix, and the second medicinal powder, azone, vinegar, and chlorhexidine acetate are added at a temperature not exceeding 45°C. After stirring and defoaming, the external medicated ointment is obtained. This invention is suitable for preparing external patch preparations for relieving symptoms of cough, wheezing, excessive phlegm, and chest tightness.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine external preparation technology, specifically relating to a medicated ointment for relieving cough and asthma and its preparation method. Background Technology

[0002] Cough and wheezing are common respiratory symptoms in clinical practice, often manifesting as cough, wheezing, excessive sputum, and chest tightness. For chronic cough, bronchial asthma in remission, chronic bronchitis, or other chronic lung diseases, in addition to conventional treatment, topical herbal patches are often used to help relieve related discomfort.

[0003] In existing topical Chinese medicine ointments or plasters, a common method involves directly pulverizing multiple Chinese herbs, adding water, honey, vinegar, or other excipients to form a paste, and then applying it to the skin. While this method is simple to prepare, it still has the following drawbacks: First, pulverizing or extracting multiple herbs together without differentiation can easily lead to uneven release and retention of active ingredients from different herbs; second, herbs containing odorous or volatile components may suffer some loss if extracted at high temperatures for extended periods; third, the uniformity, formability, and batch-to-batch consistency of ointments made solely from herbal powders are difficult to control; and fourth, water-based ointments present challenges such as viscosity changes, stratification, and difficulty in microbial control during storage and use. Summary of the Invention

[0004] The technical problem to be solved by the present invention is to provide a medicated ointment for relieving cough and asthma and a preparation method thereof. The ointment is prepared by making a portion of Chinese medicinal materials into a first Chinese medicinal extract, making another portion of Chinese medicinal materials into a second Chinese medicinal powder, and then mixing them with an external base to form an ointment. The resulting ointment has a clear medicinal composition, good ointment uniformity, and external compatibility.

[0005] To solve the above-mentioned technical problems, the present invention adopts the following technical solution.

[0006] A topical Chinese medicine ointment for relieving cough and asthma symptoms, comprising active Chinese medicine components and a topical matrix; The active components of the traditional Chinese medicine include a first traditional Chinese medicine extract and a second traditional Chinese medicine powder; The first herbal extract is made from Fritillaria cirrhosa, bitter almond, Houttuynia cordata, Salvia miltiorrhiza and licorice. The second traditional Chinese medicine powder is made from agarwood, asarum, and calamus. The traditional Chinese medicine raw materials for preparing the active components of the traditional Chinese medicine, by weight, include: 2-5 parts of agarwood, 0.8-2.5 parts of asarum, 4-7 parts of fritillaria cirrhosa, 4-6 parts of bitter almond, 1-3 parts of acorus tatarinowii, 3-6 parts of licorice, 5-9 parts of houttuynia cordata and 5-9 parts of salvia miltiorrhiza.

[0007] Preferably, the traditional Chinese medicine raw materials for preparing the active components of the traditional Chinese medicine include, by weight: 3 parts agarwood, 2 parts asarum, 5 parts fritillaria cirrhosa, 5 parts bitter almond, 2 parts acorus tatarinowii, 4 parts licorice, 6 parts houttuynia cordata and 6 parts salvia miltiorrhiza.

[0008] Preferably, based on the total mass of the topical Chinese medicine ointment, the active ingredients of the Chinese medicine account for 23% to 45%, and the topical matrix accounts for 55% to 77%.

[0009] Preferably, the first herbal extract is a paste-like extract, which is obtained by extracting and concentrating Fritillaria cirrhosa, bitter almond, Houttuynia cordata, Salvia miltiorrhiza and licorice into a thick paste.

[0010] Preferably, the first herbal extract is prepared by the following steps: Fritillaria cirrhosa, bitter almond, houttuynia cordata, salvia miltiorrhiza and licorice are pulverized to 20-40 mesh, 2%-6% of the total mass of Fritillaria cirrhosa, bitter almond, houttuynia cordata, salvia miltiorrhiza and licorice are added to vinegar, mixed and allowed to stand for 30-60 minutes, then 6-10 times the amount of 40%-60% ethanol aqueous solution is added, and the mixture is refluxed at 70-80℃ for 1-2 times, each time for 1.0-1.5 hours, filtered and concentrated under reduced pressure to a paste-like extract with a relative density of 1.15-1.25 at 60℃.

[0011] Preferably, the second traditional Chinese medicine powder is obtained by drying and pulverizing agarwood, asarum and calamus, and the particle size of the second traditional Chinese medicine powder is 200-300 mesh.

[0012] Preferably, the second herbal powder is added when the temperature of the mixture of the first herbal extract and the external application matrix drops to 40-45°C.

[0013] Preferably, based on the total mass of the external herbal ointment, the external matrix comprises 8%–15% glycerin, 5%–10% polyethylene glycol 400, 2%–6% povidone K30, 2%–5% sodium carboxymethyl cellulose, 0.2%–0.8% carbomer or sodium polyacrylate, 0.5%–1.5% azone, 3%–8% vinegar, 0.1%–0.2% chlorhexidine acetate, and the balance being purified water.

[0014] Preferably, the viscosity of the external herbal ointment at 25°C is 5000–30000 mPa·s, and the pH of the 10% aqueous dispersion is 5.0–6.5.

[0015] The present invention also provides a method for preparing the aforementioned external herbal ointment, comprising the following steps: S1. Weigh out the following ingredients according to the prescription: Fritillaria cirrhosa, bitter almond, houttuynia cordata, salvia miltiorrhiza and licorice. Grind them into powder, mix with vinegar and let stand. Then extract and concentrate with ethanol aqueous solution to obtain the first Chinese herbal extract. S2. Weigh out agarwood, asarum and calamus according to the prescription, dry and pulverize them to obtain the second Chinese medicine powder; S3. Mix glycerin, polyethylene glycol 400, povidone K30 and some purified water, add sodium carboxymethyl cellulose and carbomer or sodium polyacrylate for dispersion, and obtain the external matrix. S4. Add the first Chinese herbal extract to the external base and stir to mix. After the material temperature drops to no higher than 45°C, add the second Chinese herbal powder, azone, vinegar and chlorhexidine acetate, stir evenly and defoam to obtain the external Chinese herbal ointment.

[0016] Compared with existing technologies, this invention prepares a first traditional Chinese medicine extract from Fritillaria cirrhosa, bitter almond, Houttuynia cordata, Salvia miltiorrhiza, and licorice, and prepares a second traditional Chinese medicine powder from agarwood, Asarum heterotropoides, and Acorus tatarinowii. The second traditional Chinese medicine powder is added at a low temperature stage, avoiding prolonged high-temperature treatment of all traditional Chinese medicine raw materials, which helps maintain the distribution stability of different medicinal components in the ointment. At the same time, the external application matrix is ​​formed by components such as glycerin, polyethylene glycol 400, povidone K30, sodium carboxymethyl cellulose, carbomer, or sodium polyacrylate, giving the ointment a viscosity, moisturizing properties, and formability suitable for external application. Detailed Implementation

[0017] The present invention will be further described below with reference to the embodiments. The embodiments are used to illustrate the technical solutions of the present invention and should not be construed as limiting the scope of protection of the present invention. Unless otherwise specified, all "parts" mentioned below refer to parts by weight; all percentages refer to mass percentages; the vinegar mentioned is brewed vinegar that meets the requirements for pharmaceutical excipients or food safety; the percentage in the ethanol-water solution is a volume fraction; and the relative density is determined at 60°C.

[0018] The external herbal ointment of this invention comprises active herbal components and an external matrix. The active herbal components include a first herbal extract and a second herbal powder. The first herbal extract is made from Fritillaria cirrhosa, bitter almond, Houttuynia cordata, Salvia miltiorrhiza, and licorice; the second herbal powder is made from agarwood, Asarum heterotropoides, and Acorus tatarinowii. The first herbal extract is mixed with the external matrix to form the main body of the ointment. The second herbal powder is added and dispersed in the main body of the ointment after the temperature decreases. The external matrix acts as a carrier for the ointment, encapsulating and dispersing the first herbal extract and the second herbal powder, resulting in a uniform ointment.

[0019] In this invention, the "first herbal extract" refers to a paste-like extract formed by extracting, filtering, and concentrating Fritillaria cirrhosa, bitter almond, Houttuynia cordata, Salvia miltiorrhiza, and licorice. The "second herbal powder" refers to a powdered material formed by drying and pulverizing Aquilaria sinensis, Asarum heterotropoides, and Acorus tatarinowii. The "vinegar pre-soaking" in this invention refers to mixing the pulverized Fritillaria cirrhosa, bitter almond, Houttuynia cordata, Salvia miltiorrhiza, and licorice with vinegar and allowing it to stand, so that the vinegar comes into contact with and soaks the herbal particles; this process does not include a stir-frying step.

[0020] Example 1

[0021] This embodiment provides a topical Chinese medicine ointment for relieving cough and asthma symptoms.

[0022] The raw materials for the active components of the traditional Chinese medicine, by weight, are: 3 parts agarwood, 2 parts asarum, 5 parts fritillaria cirrhosa, 5 parts bitter almond, 2 parts acorus tatarinowii, 4 parts licorice, 6 parts houttuynia cordata, and 6 parts salvia miltiorrhiza. The total amount of the above eight raw materials is 33 parts.

[0023] Among them, Fritillaria cirrhosa, bitter almond, Houttuynia cordata, Salvia miltiorrhiza and licorice are used to prepare the first Chinese medicine extract; Agarwood, Asarum heterotropoides and Acorus tatarinowii are used to prepare the second Chinese medicine powder.

[0024] Based on the total mass of the final prepared external herbal ointment, the active ingredients of traditional Chinese medicine account for 33%, and the external matrix accounts for 67%. The external matrix includes 12% glycerin, 8% polyethylene glycol 400, 4% povidone K30, 3% sodium carboxymethyl cellulose, 0.5% carbomer, 1% azone, 5% vinegar, 0.15% chlorhexidine acetate, and the balance being purified water.

[0025] The preparation steps in this embodiment are as follows.

[0026] S1. Preparation of the first Chinese herbal extract.

[0027] Weigh out the prescribed amounts of Fritillaria cirrhosa, bitter almond, Houttuynia cordata, Salvia miltiorrhiza, and licorice. Remove impurities and mix them together. Grind the mixture to 20-40 mesh using a pulverizing device to obtain the first medicinal material mixture powder. Add 4% of the total mass of vinegar to the first medicinal material mixture powder and stir to ensure that the vinegar and the first medicinal material mixture powder are evenly contacted. Let it stand for 45 minutes to obtain the first medicinal material mixture pre-soaked in vinegar.

[0028] Eight times the volume of 50% ethanol aqueous solution was added to the first herbal mixture pre-soaked in vinegar, and the mixture was refluxed twice at 75°C for 1.2 hours each time. After each extraction, the mixture was filtered, and the filtrates were combined to obtain the first extract. The first extract was concentrated under reduced pressure until the relative density at 60°C was 1.20, yielding a paste-like extract, i.e., the first herbal extract. The first herbal extract was used as the input material for the subsequent external application matrix mixing step.

[0029] S2. Prepare the second Chinese medicine powder.

[0030] Weigh out the prescribed amounts of agarwood, asarum, and calamus, remove impurities, mix them, and dry them to a suitable dry state for pulverization. Pulverize and sieve the dried agarwood, asarum, and calamus to obtain a second herbal powder with a particle size of 200-300 mesh. This second herbal powder is used as the powder input for the subsequent low-temperature mixing step.

[0031] S3. Prepare the external matrix.

[0032] The prescribed amounts of glycerin, polyethylene glycol 400, povidone K30, and a portion of purified water were placed in a stirred container. The mixture was heated to 55–65°C and stirred to disperse povidone K30 in the liquid phase. Subsequently, sodium carboxymethyl cellulose and carbomer were added, and stirring continued for 20 minutes to ensure complete dispersion and water absorption and swelling of the sodium carboxymethyl cellulose and carbomer, forming a viscous external matrix. This external matrix serves as the dispersion carrier for the first herbal extract.

[0033] S4. Mix into a paste.

[0034] The first herbal extract obtained in S1 was added to the external application matrix obtained in S3. The mixture was stirred at 800–1200 rpm for 15 minutes to ensure the extract was evenly dispersed in the matrix, forming a paste-like base containing the extract. Heating was stopped, and the paste-like base was allowed to cool naturally or through a jacket. When the temperature dropped to 40–45°C, the second herbal powder obtained in S2, azone, vinegar, and chlorhexidine acetate were added. Stirring continued for 10–20 minutes to ensure the second herbal powder was evenly dispersed in the paste-like base. After stirring, a degassing treatment was performed to obtain the external herbal ointment.

[0035] The resulting external herbal ointment is a uniform brown to dark brown paste, without obvious clumping, layering, or water separation. The viscosity of this external herbal ointment at 25℃ is 5000–30000 mPa·s, and the pH of a 10% aqueous dispersion is 5.0–6.5.

[0036] Example 2

[0037] The raw materials of the active components of the traditional Chinese medicine, by weight, are: 2 parts agarwood, 1 part asarum, 5 parts fritillaria cirrhosa, 4 parts bitter almond, 1.5 parts acorus tatarinowii, 4 parts licorice, 6 parts houttuynia cordata and 5 parts salvia miltiorrhiza.

[0038] Based on the total mass of the final prepared external herbal ointment, the active ingredients of traditional Chinese medicine account for 28%, and the external matrix accounts for 72%. The external matrix includes 10% glycerin, 6% polyethylene glycol 400, 3% povidone K30, 3% sodium carboxymethyl cellulose, 0.4% sodium polyacrylate, 0.8% azone, 4% vinegar, 0.1% chlorhexidine acetate, and the balance being purified water.

[0039] In preparation, first weigh out Fritillaria cirrhosa, bitter almond, Houttuynia cordata, Salvia miltiorrhiza, and licorice root, pulverize them to 20-40 mesh, add 3% (by weight of the total mass of the five herbs) of vinegar, mix, and let stand for 30 minutes. Then add 6 times the volume of 40% ethanol aqueous solution, and reflux extract once at 70℃ for 1.5 hours. After extraction, filter, and concentrate the filtrate under reduced pressure to a relative density of 1.15 at 60℃ to obtain the first herbal extract.

[0040] Next, weigh out agarwood, asarum and calamus, dry, pulverize and sieve to obtain a second Chinese medicine powder with a particle size of 200 mesh.

[0041] Then, glycerin, polyethylene glycol 400, povidone K30, and some purified water were mixed, and sodium carboxymethyl cellulose and sodium polyacrylate were added. After stirring and dispersing, a topical matrix was obtained. The first herbal extract was added to the topical matrix and stirred and mixed. When the material temperature dropped to no higher than 45°C, the second herbal powder, azone, vinegar, and chlorhexidine acetate were added, stirred evenly, and defoamed to obtain a topical herbal ointment.

[0042] The external Chinese medicine ointment obtained in this embodiment is a uniform brown ointment with a pH value of 5.0 to 6.5 for a 10% aqueous dispersion and a viscosity of 5000 to 30000 mPa·s at 25°C.

[0043] Example 3

[0044] By weight, the raw materials of the active components of traditional Chinese medicine are: 4 parts agarwood, 2.5 parts asarum, 6 parts fritillaria cirrhosa, 5 parts bitter almond, 2.5 parts acorus tatarinowii, 4 parts licorice, 7 parts houttuynia cordata and 7 parts salvia miltiorrhiza.

[0045] Based on the total mass of the final prepared external herbal ointment, the active ingredients of traditional Chinese medicine account for 40%, and the external matrix accounts for 60%. The external matrix includes 15% glycerin, 10% polyethylene glycol 400, 5% povidone K30, 4% sodium carboxymethyl cellulose, 0.8% carbomer, 1.5% azone, 8% vinegar, 0.2% chlorhexidine acetate, and the balance being purified water.

[0046] In preparation, Fritillaria cirrhosa, bitter almond, Houttuynia cordata, Salvia miltiorrhiza, and licorice were pulverized to 20-40 mesh, and 6% of the total mass of the above five medicinal materials was added to vinegar. After mixing, the mixture was allowed to stand for 60 minutes. Ten times the amount of 60% ethanol aqueous solution was added, and the mixture was refluxed at 80°C twice, each time for 1.0 h. The filtrates were filtered and combined, and the filtrates were concentrated under reduced pressure to a relative density of 1.25 at 60°C to obtain the first Chinese herbal extract.

[0047] After drying, agarwood, asarum, and calamus are pulverized to 300 mesh to obtain the second type of Chinese medicine powder.

[0048] Glycerin, polyethylene glycol 400, povidone K30, and a portion of purified water were mixed, and sodium carboxymethyl cellulose and carbomer were added for dispersion to obtain a topical matrix. The first herbal extract was added to the topical matrix and mixed thoroughly under stirring. When the material temperature dropped to 40–45°C, the second herbal powder, azone, vinegar, and chlorhexidine acetate were added, and stirring was continued to defoam, resulting in a topical herbal ointment.

[0049] The external herbal ointment obtained in this embodiment is a dark brown, uniform paste without obvious layering, water separation, or hardening.

[0050] The external matrix consists of a liquid phase component, a film-forming and binding component, a thickening and water-retaining component, a penetration-enhancing component, an acidic excipient, an antibacterial excipient, and purified water. Glycerin and polyethylene glycol 400 serve as the liquid phase and moisturizing components, povidone K30 as the film-forming and binding component, sodium carboxymethyl cellulose and carbomer or sodium polyacrylate as the thickening and water-retaining components, azone as the penetration-enhancing component, vinegar as the acidic excipient, and chlorhexidine acetate as the antibacterial excipient.

[0051] When preparing the external matrix, glycerin, polyethylene glycol 400, povidone K30, and a portion of purified water are first added to a stirring container to disperse the povidone K30. Then, sodium carboxymethyl cellulose and carbomer or sodium polyacrylate are added to absorb water and disperse in the liquid phase, forming a viscous matrix. The first herbal extract is added after this viscous matrix has formed. The second herbal powder, azone, vinegar, and chlorhexidine acetate are added after the material temperature has dropped to no higher than 45°C.

[0052] In the external Chinese medicine ointment prepared according to the above order of addition, the first Chinese medicine extract is dispersed inside the external matrix, and the second Chinese medicine powder is dispersed in the ointment system in the form of powder particles. The external matrix encapsulates the first Chinese medicine extract and the second Chinese medicine powder together to form a uniform ointment.

Claims

1. A medicated ointment for relieving cough and asthma, characterized in that, Includes active ingredients of traditional Chinese medicine and external application matrix; The active components of the traditional Chinese medicine are composed of a first traditional Chinese medicine extract and a second traditional Chinese medicine powder; The first herbal extract is made from Fritillaria cirrhosa, bitter almond, Houttuynia cordata, Salvia miltiorrhiza and licorice. The second traditional Chinese medicine powder is made from agarwood, asarum, and calamus. The traditional Chinese medicine raw materials for preparing the active components of the traditional Chinese medicine, by weight, include: 2-5 parts of agarwood, 0.8-2.5 parts of asarum, 4-7 parts of fritillaria cirrhosa, 4-6 parts of bitter almond, 1-3 parts of acorus tatarinowii, 3-6 parts of licorice, 5-9 parts of houttuynia cordata and 5-9 parts of salvia miltiorrhiza.

2. The ointment according to claim 1, characterized in that, The traditional Chinese medicine raw materials for preparing the active components of the traditional Chinese medicine, by weight, include: 3 parts agarwood, 2 parts asarum, 5 parts fritillaria cirrhosa, 5 parts bitter almond, 2 parts acorus tatarinowii, 4 parts licorice, 6 parts houttuynia cordata and 6 parts salvia miltiorrhiza.

3. The ointment according to claim 1, characterized in that, Based on the total mass of the external herbal ointment, the active ingredients of the traditional Chinese medicine account for 23% to 45%, and the external matrix accounts for 55% to 77%.

4. The ointment according to claim 1, characterized in that, The first herbal extract is a paste-like extract, which is obtained by extracting and concentrating Fritillaria cirrhosa, bitter almond, Houttuynia cordata, Salvia miltiorrhiza and licorice into a thick paste.

5. The ointment according to claim 4, characterized in that, The first herbal extract was prepared by the following steps: Fritillaria cirrhosa, bitter almond, houttuynia cordata, salvia miltiorrhiza and licorice were pulverized to 20-40 mesh, and 2%-6% of the total mass of Fritillaria cirrhosa, bitter almond, houttuynia cordata, salvia miltiorrhiza and licorice were added to vinegar. After mixing, the mixture was allowed to stand for 30-60 minutes, and then 6-10 times the amount of 40%-60% ethanol aqueous solution was added. The mixture was refluxed at 70-80℃ for 1-2 times, each time for 1.0-1.5 hours. After filtration, the mixture was concentrated under reduced pressure to a paste-like extract with a relative density of 1.15-1.25 at 60℃.

6. The ointment according to claim 1, characterized in that, The second traditional Chinese medicine powder is obtained by drying and pulverizing agarwood, asarum and calamus, and the particle size of the second traditional Chinese medicine powder is 200-300 mesh.

7. The ointment according to claim 6, characterized in that, The second herbal powder is added when the temperature of the mixture of the first herbal extract and the external matrix drops to 40-45°C.

8. The ointment according to claim 1, characterized in that, Based on the total mass of the external herbal ointment, the external matrix comprises 8%–15% glycerin, 5%–10% polyethylene glycol 400, 2%–6% povidone K30, 2%–5% sodium carboxymethyl cellulose, 0.2%–0.8% carbomer or sodium polyacrylate, 0.5%–1.5% azone, 3%–8% vinegar, 0.1%–0.2% chlorhexidine acetate, and the balance being purified water.

9. The ointment according to claim 1, characterized in that, The viscosity of the topical Chinese medicine ointment at 25°C is 5000–30000 mPa·s, and the pH of the 10% aqueous dispersion is 5.0–6.

5.

10. A method for preparing an ointment as described in any one of claims 1 to 9, characterized in that, Includes the following steps: S1. Weigh out the following ingredients according to the prescription: Fritillaria cirrhosa, bitter almond, houttuynia cordata, salvia miltiorrhiza and licorice. Grind them into powder, mix with vinegar and let stand. Then extract and concentrate with ethanol aqueous solution to obtain the first Chinese herbal extract. S2. Weigh out agarwood, asarum and calamus according to the prescription, dry and pulverize them to obtain the second Chinese medicine powder; S3. Mix glycerin, polyethylene glycol 400, povidone K30 and some purified water, add sodium carboxymethyl cellulose and carbomer or sodium polyacrylate for dispersion, and obtain the external matrix. S4. Add the first Chinese herbal extract to the external base and stir to mix. After the material temperature drops to no higher than 45°C, add the second Chinese herbal powder, azone, vinegar and chlorhexidine acetate, stir evenly and defoam to obtain the external Chinese herbal ointment.