Traditional Chinese medicine composition for treating rhinitis, preparation and preparation method thereof

Abstract

The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to a traditional Chinese medicine composition for treating rhinitis, a preparation and a preparation method thereof. The traditional Chinese medicine composition follows the principle of compatibility of monarch, minister, assistant and guide, and is prepared from flos magnoliae, fructus xanthii, centipeda minima, radix angelicae, rhizoma atractylodis, rhizoma acori graminei, radix scutellariae, ligusticum wallichii and mint, the multiple components act on multiple pathogenesis of rhinitis in a synergistic manner, and both symptoms and root causes are treated. The traditional Chinese medicine composition ointment is prepared by mixing the traditional Chinese medicine composition extract, permeation enhancing auxiliary materials and pharmaceutically acceptable auxiliary materials, the permeation enhancing auxiliary materials have a synergistic effect, so that the transdermal permeation efficiency of the medicine can be improved, the medicine can be promoted to quickly and directly reach an inflammation part, the rhinitis related symptoms can be effectively improved, and the traditional Chinese medicine composition ointment is suitable for a wide range of people and has a good application prospect. And a safe and efficient local treatment scheme is provided for a nasal inflammation patient.

Description

Technical Field

[0001] This invention belongs to the field of pharmaceutical preparation technology, specifically relating to a traditional Chinese medicine composition, preparation and preparation method for treating rhinitis. Background Technology

[0002] The information disclosed in this background section is intended only to enhance understanding of the overall background of the invention and is not necessarily to be construed as an admission or in any way implying that such information constitutes prior art known to those skilled in the art.

[0003] Inflammatory nasal diseases (such as allergic rhinitis, chronic rhinitis, and sinusitis) are common respiratory illnesses, with their incidence rate increasing globally, especially in urban populations. These diseases are characterized by nasal congestion, runny nose, sneezing, nasal itching, and decreased sense of smell, severely impacting patients' daily lives, work, and sleep quality. Some patients may also develop complications such as otitis media, pharyngitis, and asthma, placing a significant physical and psychological burden on them.

[0004] Currently, there are various clinical treatments for inflammatory diseases of the nose, mainly including oral medications, nasal sprays, and topical ointments. Oral medications (such as antihistamines, corticosteroids, and antibiotics) can relieve symptoms to some extent, but they have significant systemic side effects (such as drowsiness, gastrointestinal discomfort, and liver and kidney damage), low local drug concentrations, and slow onset of action. Furthermore, long-term use can easily lead to drug resistance. Nasal sprays (such as corticosteroid sprays and decongestants) act directly on the nasal cavity and have a faster onset of action. However, long-term use of corticosteroid sprays may lead to adverse reactions such as nasal mucosal atrophy and nosebleeds, while decongestants are prone to causing drug dependence, and symptoms are likely to rebound after discontinuation, thus limiting their use.

[0005] Traditional Chinese medicine (TCM) has unique advantages in treating nasal inflammation, emphasizing syndrome differentiation and treatment that addresses both the root cause and symptoms. It alleviates symptoms and improves the nasal cavity's physiological environment through the synergistic effects of multiple components and targets. Magnolia flower, Xanthium fruit, and Angelica dahurica are classic TCM herbs for treating nasal diseases, possessing the effects of dispersing wind-cold, clearing nasal passages, and clearing heat and detoxifying. They have been widely used in various nasal disease prescriptions. However, existing TCM external preparations still have many shortcomings: on the one hand, some formulas lack a scientific design of principal, assistant, and adjuvant herbs, resulting in unbalanced component ratios, unstable efficacy, and difficulty in fully exerting synergistic effects; on the other hand, the preparation processes are relatively simple, often using direct pulverization and mixing or simple extraction methods, resulting in insufficient extraction of effective components and poor drug permeability, making it difficult to cross the nasal mucosal barrier and reach the inflamed site, affecting the onset of action and therapeutic effect; in addition, some preparations use highly irritating matrices, easily causing discomfort to the nasal mucosa, or have problems such as inappropriate viscosity and poor adhesion, leading to a poor user experience. For example, patent CN11949930A discloses a traditional Chinese medicine composition for treating allergic rhinitis, composed of cicada molting, centipede, magnolia flower, angelica, centipeda minima, and cocklebur. Although it can improve the immune disorder in animal models and patients with allergic rhinitis, this composition is an oral preparation, which carries the risk of systemic side effects, and the local drug concentration in the nasal cavity is difficult to guarantee, affecting the direct effect on the inflamed area of ​​the nasal cavity. Patent CN111249389A relates to a traditional Chinese medicine composition for the prevention and / or treatment of dry nose, using cocklebur, magnolia flower, and centipeda minima as raw materials. The dosage form is oral capsules or external oil. The adhesion and ease of use of the oil are not as good as the ointment, and the composition focuses more on moisturizing and promoting saliva production, which is lacking in the specificity of clearing the nasal passages and reducing inflammation.

[0006] Therefore, the present invention aims to develop a nasal ointment with a clearly defined formula of principal, assistant, adjuvant, and guide ingredients. By optimizing the composition of excipients, the ointment is prepared to achieve rapid local penetration of the drug and continuous action on the inflamed site, providing a safer, more efficient, and convenient local treatment option for patients with nasal inflammation. Summary of the Invention

[0007] The purpose of this invention is to provide a traditional Chinese medicine composition and its ointment for treating rhinitis, which has precise formulation of principal, assistant, adjuvant, and guide herbs, high transdermal penetration efficiency, significant therapeutic effect, and good safety, so as to solve the above-mentioned problems existing in the prior art.

[0008] This invention provides a traditional Chinese medicine composition for treating rhinitis, consisting of the following parts by weight of traditional Chinese medicine raw materials, and strictly following the principles of monarch-minister-assistant-guide compatibility: The principal herbs are: Magnolia biondii 10 parts by weight and Xanthium sibiricum 6 parts by weight. Together, they are the principal herbs, which can powerfully clear the nasal passages and dispel wind-cold, directly addressing the core pathogenesis of rhinitis: "nasal obstruction and external wind-cold".

[0009] Assistant herbs: 6 parts by weight of Centipeda minima and 6 parts by weight of Angelica dahurica, serving as assistant herbs to the principal herbs, enhance the effects of clearing the nasal passages, dispelling cold, reducing swelling and relieving pain, and further strengthen the function of clearing the nasal passages.

[0010] The adjuvant herbs are: 10 parts Atractylodes lancea, 6 parts Acorus tatarinowii, 6 parts Scutellaria baicalensis, and 6 parts Ligusticum chuanxiong. Atractylodes lancea dries dampness and strengthens the spleen, while Acorus tatarinowii aromatically transforms turbidity. The two herbs help the principal and assistant herbs to dispel dampness and open the nasal passages. Scutellaria baicalensis clears heat and dries dampness to relieve nasal inflammation. Ligusticum chuanxiong invigorates blood and promotes qi circulation to reduce pain around the nose. All four herbs work together to support the body's resistance and eliminate pathogens, thus regulating the overall pathogenesis.

[0011] The guiding ingredient is 4 parts by weight of peppermint, which guides the medicine upwards to the nasal cavity and relieves itching. It also harmonizes the properties of the other ingredients, so that the efficacy of the whole formula is concentrated on the nasal cavity.

[0012] The herbal composition of this invention, through precise formulation of principal, assistant, adjuvant, and guide herbs, has multiple components working synergistically to address the multiple pathogenesis mechanisms of rhinitis (especially allergic rhinitis) such as "wind, cold, dampness, heat, and blood stasis," achieving both symptomatic and root-cause treatment by "opening the nasal passages, dispelling cold, removing dampness, clearing heat, and promoting blood circulation." It can specifically improve typical symptoms such as nasal congestion, runny nose, nasal itching, and sneezing.

[0013] The present invention also provides an ointment comprising the above-mentioned traditional Chinese medicine composition, wherein the ointment is prepared by mixing an extract of the traditional Chinese medicine composition with excipients, wherein: Permeation-enhancing excipients: Azone 1.0-3.0 parts by weight, glyceryl glucoside 2.0-4.0 parts by weight, and 2,6-nonadienol 0.5-1.5 parts by weight. The synergistic effect of these three ingredients significantly improves the transdermal penetration efficiency of the active ingredients in traditional Chinese medicine, promoting rapid absorption of the drug through the nasal mucosa and direct delivery to the site of inflammation. Matrix excipients: Selected from petrolatum, lanolin, beeswax, insect wax, liquid paraffin, vegetable oil, hydrogenated vegetable oil, stearic acid, glyceryl monostearate, PEG400, PEG6000, and PEG8000. Carbomer, hydroxypropyl methylcellulose, sodium carboxymethyl cellulose, sodium alginate, xanthan gum, stearyl alcohol, cetyl alcohol, stearyl alcohol, polysorbates, Span derivatives, polyoxyethylene hydrogenated castor oil, glyceryl monostearate, sodium lauryl sulfate, sodium laureth sulfate, glycerin, propylene glycol, sorbitol, polyglycerol-3, betaine, sodium hyaluronate, allantoin, panthenol, trehalose, hydroxyphenyl esters, phenoxyethanol, chlorphenesin, benzalkonium chloride, benzalkonium bromide, sorbic acid, sodium dehydroacetate, menthol, xanthan gum, melon Gum, gum arabic, pectin, carrageenan, hydroxyethyl cellulose, methyl cellulose, sodium polyacrylate, silica, bentonite, montmorillonite, triethanolamine, diethanolamine, ethanolamine, sodium hydroxide, potassium hydroxide, hydrochloric acid, citric acid, lactic acid, sodium dihydrogen phosphate, disodium hydrogen phosphate, acetate-sodium acetate buffer solution, ethanol, propylene glycol, water, glycerin, polyethylene glycol 400, dimethyl sulfoxide, dimethylformamide, glycerol, poloxamer, vitamin E, sodium bisulfite, sodium metabisulfite, sodium thiosulfate, tert-butyl Pharmaceutically acceptable excipients such as p-hydroxyanisole, di-tert-butyl-p-cresol, propyl gallate, ascorbyl palmitate, peppermint oil, eucalyptus oil, lavender oil, lemon oil, rose oil, clove oil, cinnamon oil, tangerine peel oil, lemongrass oil, borneol, camphor, dipotassium glycyrrhizate, allantoin, aloe vera extract, panthenol, ceramide, cholesterol, talc, micronized silica gel, magnesium stearate, disodium EDTA, and trisodium citrate can be flexibly formulated and their dosage adjusted according to the stability, spreadability, and adhesion requirements of the ointment.

[0014] The present invention further provides a method for preparing the above-mentioned ointment, comprising the following steps: Preparation of Chinese herbal extracts: The raw materials of Chinese herbs in the combination of principal, assistant, adjuvant and guide herbs are crushed, and the volatile oils (such as the volatile effective components in Magnolia biondii and Mentha haplocalyx) are extracted by steam distillation. The residue is then extracted by water decoction and concentrated into a concentrated decoction. The volatile oils and concentrated decoction are mixed to obtain the Chinese herbal extract. Oil phase preparation: Weigh the oil phase matrix excipients, heat them to 70-80℃ to melt, add azone and 2,6-nonadienol, and stir until uniform; Aqueous phase preparation: Weigh water-soluble matrix excipients and mix with purified water, heat to 60-75℃, and stir to dissolve to form an aqueous phase; Emulsification and shaping: Slowly add the aqueous phase to the oil phase while stirring until emulsification is complete; after cooling to 38-45℃, add the Chinese herbal extract and remaining excipients (such as preservatives, flavorings, etc.), and stir quickly to room temperature to obtain a uniform paste.

[0015] The preparation method of this invention fully preserves the effective components (including volatile oils and water-soluble components) of each of the principal, assistant, adjuvant, and guide herbs. The stepwise emulsification process ensures the stability and uniformity of the ointment, enabling the active pharmaceutical ingredients to exert a stable synergistic effect.

[0016] The traditional Chinese medicine composition and ointment containing it of the present invention can be used to prepare medicines for treating rhinitis, especially for treating allergic rhinitis. In clinical applications, the composition and ointment can effectively relieve typical symptoms of allergic rhinitis such as nasal congestion, runny nose, nasal itching, and sneezing, while also improving accompanying problems such as itchy eyes, tearing, and sleep disorders caused by rhinitis. Moreover, as a topical nasal preparation, it avoids the systemic side effects of oral medications. It can be applied directly to the area around the nasal cavity or mucosa, making it convenient, safe, and suitable for a wide range of people.

[0017] Compared with the prior art, the present invention has the following significant advantages: (1) Innovative formulation: This invention is the first to use magnolia flower and cocklebur as the principal herbs, centipeda grass and angelica as the assistant herbs, atractylodes, calamus, scutellaria and chuanxiong as the adjuvant herbs, and peppermint as the guide herbs for the treatment of rhinitis. The principal, assistant, adjuvant and guide herbs are clearly defined and work synergistically to target multiple pathogenesis links of nasal cavity inflammation, resulting in a more comprehensive and stable therapeutic effect.

[0018] (2) High efficiency of penetration enhancement: The present invention uses a synergistic penetration enhancement system of azone, glycerol glucoside and 2,6-nonadienol, which significantly improves the skin penetration rate and cumulative penetration amount of the active ingredients of traditional Chinese medicine compared with conventional preparations, ensuring that the drug can quickly reach the inflamed site to take effect.

[0019] (3) Safety of formulation: This invention uses a local external administration route to avoid the first-pass effect of the liver and the accumulation of drugs throughout the body. Long-term use has no obvious toxic side effects and is suitable for a wide range of people. Attached Figure Description

[0020] Figure 1 Cumulative penetration of ointments in Examples 4-8 and Comparative Examples 1-6. Detailed Implementation

[0021] To make the objectives and technical solutions of this invention clearer, the following embodiments are provided for further explanation. However, the scope of protection of this invention is not limited to these embodiments; the embodiments are merely for illustrative purposes. Those skilled in the art should understand that any changes or equivalent substitutions that do not depart from the concept of this invention are included within the scope of protection of this invention.

[0022] Example 1: Traditional Chinese Medicine Composition formula: Magnolia flower 10g, Xanthium fruit 6g, Centipeda grass 6g, Angelica dahurica 6g, Atractylodes lancea 10g, Acorus tatarinowii 6g, Scutellaria baicalensis 6g, Ligusticum chuanxiong 6g, Mentha haplocalyx 4g.

[0023] Preparation method: After pulverizing the above-mentioned Chinese herbs, the volatile oil was extracted by steam distillation. The residue was then boiled in water to obtain a concentrated decoction. The decoction was mixed with the residue and then mixed with a petrolatum base to make an ointment.

[0024] Example 2: Traditional Chinese Medicine Composition Formula: Magnolia biondii 5g, Xanthium sibiricum 4g, Centipeda minima 4g, Angelica dahurica 4g, Atractylodes lancea 5g, Acorus tatarinowii 3g, Scutellaria baicalensis 3g, Ligusticum chuanxiong 3g, Mentha haplocalyx 2g.

[0025] Preparation method: After pulverizing the above-mentioned Chinese herbs, the volatile oil was extracted by steam distillation. The residue was then boiled in water to obtain a concentrated decoction. The decoction was mixed with the residue and then mixed with a petrolatum base to make an ointment.

[0026] Example 3: Traditional Chinese Medicine Composition Formula: Magnolia biondii 15g, Xanthium sibiricum 10g, Centipeda minima 10g, Angelica dahurica 10g, Atractylodes lancea 15g, Acorus tatarinowii 8g, Scutellaria baicalensis 8g, Ligusticum chuanxiong 8g, Mentha haplocalyx 6g.

[0027] Preparation method: After pulverizing the above-mentioned Chinese herbs, the volatile oil was extracted by steam distillation. The residue was then boiled in water to obtain a concentrated decoction. The decoction was mixed with the residue and then mixed with a petrolatum base to make an ointment.

[0028] Example 1: Statistical analysis of clinical cases of treating allergic rhinitis with traditional Chinese medicine composition. I. Basic characteristics of the cases (n=107 cases) (a) Gender distribution Of the 107 allergic rhinitis patients included in this study, 59 were male (55.14%) and 48 were female (44.86%). The relatively balanced distribution of male and female patients suggests that this treatment method is applicable to patients of both genders.

[0029] (II) Age Group Distribution Of the 107 allergic rhinitis patients included in this study, 23 were aged 3-6 years (21.5%), 68 were aged 6-12 years (63.55%), the highest proportion of the group in this study, 14 were aged 12 years and older (13.08%), and 2 were adults (1.87%).

[0030] II. Statistics related to treatment plans Table 1 Distribution of Treatment Frequency III. Statistics on the Effects of Core Technologies (Symptom and Quality of Life Improvement) (a) Degree of symptom improvement (the higher the score, the more severe the symptoms; 0 points = no symptoms, 10 points = extremely severe) Table 2 Symptom Improvement Score Table 2 shows that after treatment, the patients' symptoms such as nasal congestion, runny nose, nasal itching, sneezing, eye itching, and tearing were all improved, and their self-perceived discomfort was also relieved, with significant overall symptom improvement.

[0031] (ii) Impact on quality of life (the higher the score, the more severe the impact; 0 points = no impact, 10 points = extremely severe impact) Table 3 Score of Impact on Quality of Life Improvement Table 3 shows that after treatment, the impact on patients' sleep, daily life and study, and emotions was significantly reduced, the impact on social activities was also alleviated, and the overall quality of life was improved.

[0032] Example 4 Ointment Traditional Chinese medicine prescription: Magnolia biondii 10g, Xanthium sibiricum 6g, Centipeda minima 6g, Angelica dahurica 6g, Atractylodes lancea 10g, Acorus tatarinowii 6g, Scutellaria baicalensis 6g, Ligusticum chuanxiong 6g, Mentha haplocalyx 4g.

[0033] Excipients: Azone 2g, Glyceryl glucoside 3g, 2,6-Nonadienol 1g; Oil phase excipients: Vaseline 25g, Lanolin 8g, Beeswax 4g, Liquid Paraffin 10g; Emulsifier: Span-80 2g; Humectant: Glycerin 5g; Preservative: Ethylparaben 0.2g; Balance: Purified water (to bring to 100g).

[0034] Preparation method: The above-mentioned Chinese herbal medicines were pulverized and the volatile oils were extracted by steam distillation. The residue was boiled in water to obtain a concentrated decoction, which was then mixed to form a Chinese herbal medicine extract. Vaseline, lanolin, beeswax, and liquid paraffin were heated to 75°C to melt, and Span-80, azone, and 2,6-nonadienol were added and stirred evenly to form an oil phase. Purified water, glycerol, and glycerol glucoside were heated to 70°C, and ethylparaben was added to dissolve them to form an aqueous phase. The aqueous phase was slowly added to the oil phase while stirring until emulsification was complete, and the temperature was lowered to 45°C. The Chinese herbal medicine extract was then added and stirred rapidly to room temperature to obtain the final product.

[0035] Example 5 Ointment Traditional Chinese medicine prescription: Magnolia biondii 10g, Xanthium sibiricum 6g, Centipeda minima 6g, Angelica dahurica 6g, Atractylodes lancea 10g, Acorus tatarinowii 6g, Scutellaria baicalensis 6g, Ligusticum chuanxiong 6g, Mentha haplocalyx 4g.

[0036] Excipients: Azone 2g, Glyceryl glucoside 3g, 2,6-Nonadienol 1g; Oil phase excipients: Stearic acid 6g, Cetyl alcohol 5g, Liquid paraffin 8g; Aqueous phase excipients: Propylene glycol 6g, Carbomer 940 0.5g; Emulsifier: Polysorbate-80 3g; Neutralizer: Triethanolamine 0.8g; Preservative: Phenoxyethanol 0.5g; Balance: Purified water (to bring to 100g).

[0037] Preparation method: After pulverizing the above-mentioned Chinese herbal medicines, the volatile oils were extracted by steam distillation. The residue was boiled in water to obtain a concentrated decoction, which was then mixed to form the Chinese herbal medicine extract. Stearic acid, cetyl alcohol, and liquid paraffin were heated to 75°C to melt, and azone and 2,6-nonadienol were added to obtain the oil phase. Purified water, propylene glycol, and glyceryl glucoside were heated to 75°C, and carbomer was added and stirred to dissolve, resulting in the aqueous phase. The oil phase was added to the aqueous phase, stirred and emulsified, and triethanolamine was added dropwise to adjust the pH to 6.5-7.0. The mixture was then cooled to 40°C, and the Chinese herbal medicine extract and phenoxyethanol were added. The mixture was stirred until it solidified, thus obtaining the final product.

[0038] Example 6 Ointment Traditional Chinese medicine prescription: Magnolia biondii 10g, Xanthium sibiricum 6g, Centipeda minima 6g, Angelica dahurica 6g, Atractylodes lancea 10g, Acorus tatarinowii 6g, Scutellaria baicalensis 6g, Ligusticum chuanxiong 6g, Mentha haplocalyx 4g.

[0039] Excipients: Azone 2g, Glyceryl glucoside 3g, 2,6-Nonadienol 1g; Oil phase excipients: Hydrogenated vegetable oil 10g, Stearyl alcohol 7g, Glyceryl monostearate 3g; Aqueous phase excipients: Sodium hyaluronate 0.1g, Panthenol 2g, Ceramide 1g; Emulsifier: Polyoxyethylene hydrogenated castor oil 2.5g; Antioxidant: Vitamin E 0.3g; Preservative: Chlorphenesin 0.4g; Balance: Purified water (to 100g).

[0040] Preparation method: After pulverizing the above-mentioned Chinese herbal medicines, the volatile oils were extracted by steam distillation. The residue was boiled in water to obtain a concentrated decoction, which was then mixed to form a Chinese herbal medicine extract. Hydrogenated vegetable oil, stearyl alcohol, and glyceryl monostearate were heated to 80°C to melt, and vitamin E, azone, and 2,6-nonadienol were added and stirred (oil phase). Purified water, glyceryl glucoside, sodium hyaluronate, panthenol, and ceramide were heated to 80°C to dissolve (aqueous phase). The aqueous phase was added to the oil phase and emulsified by high-speed stirring, and then cooled to 42°C. The Chinese herbal medicine extract and chlorphenesin were added and stirred until a uniform paste was formed, which yielded the final product.

[0041] Example 7 Ointment Traditional Chinese medicine prescription: Magnolia biondii 10g, Xanthium sibiricum 6g, Centipeda minima 6g, Angelica dahurica 6g, Atractylodes lancea 10g, Acorus tatarinowii 6g, Scutellaria baicalensis 6g, Ligusticum chuanxiong 6g, Mentha haplocalyx 4g.

[0042] Excipients: Azone 1g, Glyceryl glucoside 2g, 2,6-Nonadienol 0.5g; Water-soluble matrix: PEG40015g, PEG60008g; Moisturizer: Sorbitol 4g; Emulsifier: Poloxamer 1882g; Soothing ingredient: Aloe vera extract 2g; Preservative: Benzalkonium chloride 0.05g; Balance: Purified water (to bring to 100g).

[0043] Preparation method: After pulverizing the above-mentioned Chinese herbal medicines, the volatile oils were extracted by steam distillation. The residue was boiled in water to obtain a concentrated decoction, which was then mixed to form a Chinese herbal medicine extract. PEG400 and PEG6000 were heated to 65°C to melt, and poloxamer 188, azone, and 2,6-nonadienol were added and stirred to dissolve. Purified water, glyceryl glucoside, sorbitol, and benzalkonium chloride were heated to 60°C to dissolve. The two phases were stirred and mixed, and the concentrated Chinese herbal medicine decoction was added. The temperature was lowered to 40°C. The Chinese herbal medicine extract and aloe vera extract were added and stirred until solidified to obtain the final product.

[0044] Example 8 Ointment Traditional Chinese medicine prescription: Magnolia biondii 10g, Xanthium sibiricum 6g, Centipeda minima 6g, Angelica dahurica 6g, Atractylodes lancea 10g, Acorus tatarinowii 6g, Scutellaria baicalensis 6g, Ligusticum chuanxiong 6g, Mentha haplocalyx 4g.

[0045] Excipients: Azone 3g, Glyceryl glucoside 4g, 2,6-Nonadienol 1.5g; Oil phase excipients: Vegetable oil (olive oil) 6g, Stearic acid 4g; Aqueous phase excipients: Polyglycerol-33g, Betaine 2g, Xanthan gum 0.3g, Guar gum 0.2g; Emulsifier: Sodium lauryl ether sulfate 1.5g; Fragrance: Menthol 0.5g; Preservative: Sorbic acid 0.3g; Balance: Purified water (to bring to 100g).

[0046] Preparation method: After pulverizing the above-mentioned Chinese herbal medicines, the volatile oils were extracted by steam distillation. The residue was boiled in water to obtain a concentrated decoction, which was then mixed to form the Chinese herbal medicine extract. The vegetable oil and stearic acid were heated to 70°C to melt, and azone and 2,6-nonadienol were added and mixed to obtain the oil phase. The purified water, glyceryl glucoside, polyglycerol-3, betaine, xanthan gum, and guar gum were heated to 70°C and stirred until there were no particles (aqueous phase). The oil phase was slowly added to the aqueous phase, and sodium lauryl ether sulfate was added and stirred to emulsify. The temperature was lowered to 38°C, and the Chinese herbal medicine extract, menthol, and sorbic acid were added and stirred until the paste was uniform.

[0047] Comparative Example 1 Ointment Traditional Chinese medicine prescription: Magnolia biondii 10g, Xanthium sibiricum 6g, Centipeda minima 6g, Angelica dahurica 6g, Atractylodes lancea 10g, Acorus tatarinowii 6g, Scutellaria baicalensis 6g, Ligusticum chuanxiong 6g, Mentha haplocalyx 4g.

[0048] Excipients: Azone 3g; Oil phase excipients: Vaseline 25g, Lanolin 8g, Beeswax 4g, Liquid Paraffin 10g; Emulsifier: Span-80 2g; Humectant: Glycerin 5g; Preservative: Ethylparaben 0.2g; Balance: Purified water (to bring the total to 100g).

[0049] Preparation method: After pulverizing the above-mentioned Chinese herbal medicines, the volatile oils were extracted by steam distillation. The residue was boiled in water to obtain a concentrated decoction, which was then mixed to form a Chinese herbal medicine extract. Vaseline, lanolin, beeswax, and liquid paraffin were heated to 75°C to melt, and Span-80 and azone were added and stirred evenly to form an oil phase. Purified water and glycerin were heated to 70°C, and ethylparaben was added to dissolve them to form an aqueous phase. The aqueous phase was slowly added to the oil phase while stirring until emulsification was complete, and the temperature was lowered to 45°C. The Chinese herbal medicine extract was added and stirred rapidly to room temperature to obtain the final product.

[0050] Comparative Example 2: Ointment Traditional Chinese medicine prescription: Magnolia biondii 10g, Xanthium sibiricum 6g, Centipeda minima 6g, Angelica dahurica 6g, Atractylodes lancea 10g, Acorus tatarinowii 6g, Scutellaria baicalensis 6g, Ligusticum chuanxiong 6g, Mentha haplocalyx 4g.

[0051] Excipients: Azone 2g, 2,6-nonadienol 1g; Oil phase excipients: Vaseline 25g, lanolin 8g, beeswax 4g, liquid paraffin 10g; Emulsifier: Span-80 2g; Humectant: Glycerin 5g; Preservative: Ethylparaben 0.2g; Balance: Purified water (to bring the total to 100g).

[0052] Preparation method: After pulverizing the above-mentioned Chinese herbal medicines, the volatile oils were extracted by steam distillation. The residue was boiled in water to obtain a concentrated decoction, which was then mixed to form a Chinese herbal medicine extract. Vaseline, lanolin, beeswax, and liquid paraffin were heated to 75°C to melt, and Span-80, azone, and 2,6-nonadienol were added and stirred evenly to form an oil phase. Purified water and glycerin were heated to 70°C, and ethylparaben was added to dissolve them to form an aqueous phase. The aqueous phase was slowly added to the oil phase while stirring until emulsification was complete, and then cooled to 45°C. The Chinese herbal medicine extract was added and stirred rapidly to room temperature to obtain the final product.

[0053] Comparative Example 3 Ointment Traditional Chinese medicine prescription: Magnolia biondii 10g, Xanthium sibiricum 6g, Centipeda minima 6g, Angelica dahurica 6g, Atractylodes lancea 10g, Acorus tatarinowii 6g, Scutellaria baicalensis 6g, Ligusticum chuanxiong 6g, Mentha haplocalyx 4g.

[0054] Excipients: Azone 2g, Glyceryl glucoside 3g; Oil phase excipients: Vaseline 25g, Lanolin 8g, Beeswax 4g, Liquid Paraffin 10g; Emulsifier: Span-80 2g; Humectant: Glycerin 5g; Preservative: Ethylparaben 0.2g; Balance: Purified water (to bring the total to 100g).

[0055] Preparation method: After pulverizing the above-mentioned Chinese herbal medicines, the volatile oils were extracted by steam distillation. The residue was boiled in water to obtain a concentrated decoction, which was then mixed to form a Chinese herbal medicine extract. Vaseline, lanolin, beeswax, and liquid paraffin were heated to 75°C to melt, and Span-80 and azone were added and stirred evenly to form an oil phase. Purified water, glycerol, and glyceryl glucoside were heated to 70°C, and ethylparaben was added to dissolve them to form an aqueous phase. The aqueous phase was slowly added to the oil phase while stirring until emulsification was complete, and the temperature was lowered to 45°C. The Chinese herbal medicine extract was then added and stirred rapidly to room temperature to obtain the final product.

[0056] Comparative Example 4 Ointment Traditional Chinese medicine prescription: Magnolia biondii 10g, Xanthium sibiricum 6g, Centipeda minima 6g, Angelica dahurica 6g, Atractylodes lancea 10g, Acorus tatarinowii 6g, Scutellaria baicalensis 6g, Ligusticum chuanxiong 6g, Mentha haplocalyx 4g.

[0057] Excipients: Azone 2g, Glyceryl glucoside 3g, Propylene glycol 1g; Oil phase excipients: Vaseline 25g, Lanolin 8g, Beeswax 4g, Liquid paraffin 10g; Emulsifier: Span-80 2g; Humectant: Glycerin 5g; Preservative: Ethylparaben 0.2g; Balance: Purified water (to bring to 100g).

[0058] Preparation method: After pulverizing the above-mentioned Chinese herbal medicines, the volatile oils were extracted by steam distillation. The residue was boiled in water to obtain a concentrated decoction, which was then mixed to form a Chinese herbal medicine extract. Vaseline, lanolin, beeswax, and liquid paraffin were heated to 75°C to melt, and Span-80 and azone were added and stirred evenly to form an oil phase. Purified water, glycerol, propylene glycol, and glyceryl glucoside were heated to 70°C, and ethylparaben was added to dissolve them to form an aqueous phase. The aqueous phase was slowly added to the oil phase while stirring until emulsification was complete, and the temperature was lowered to 45°C. The Chinese herbal medicine extract was then added and stirred rapidly to room temperature to obtain the final product.

[0059] Comparative Example 5 Ointment Traditional Chinese medicine prescription: Magnolia biondii 10g, Xanthium sibiricum 6g, Centipeda minima 6g, Angelica dahurica 6g, Atractylodes lancea 10g, Acorus tatarinowii 6g, Scutellaria baicalensis 6g, Ligusticum chuanxiong 6g, Mentha haplocalyx 4g.

[0060] Excipients: Azone 2g, Hyaluronic acid 3g, 2,6-Nonadienol 1g; Oil phase excipients: Vaseline 25g, Lanolin 8g, Beeswax 4g, Liquid paraffin 10g; Emulsifier: Span-80 2g; Humectant: Glycerin 5g; Preservative: Ethylparaben 0.2g; Balance: Purified water (to bring to 100g).

[0061] Preparation method: After pulverizing the above-mentioned Chinese herbal medicines, the volatile oils were extracted by steam distillation. The residue was boiled in water to obtain a concentrated decoction, which was then mixed to form a Chinese herbal medicine extract. Vaseline, lanolin, beeswax, and liquid paraffin were heated to 75°C to melt, and Span-80, azone, and 2,6-nonadienol were added and stirred evenly to form an oil phase. Purified water and glycerin were mixed and heated to 70°C. Ethylparaben and hyaluronic acid were added and dissolved to form an aqueous phase. The aqueous phase was slowly added to the oil phase while stirring until emulsification was complete, and then cooled to 45°C. The Chinese herbal medicine extract was added and quickly stirred to room temperature to obtain the final product.

[0062] Comparative Example 6 Ointment Traditional Chinese medicine prescription: Magnolia biondii 10g, Xanthium sibiricum 6g, Centipeda minima 6g, Angelica dahurica 6g, Atractylodes lancea 10g, Acorus tatarinowii 6g, Scutellaria baicalensis 6g, Ligusticum chuanxiong 6g, Mentha haplocalyx 4g.

[0063] Excipients: Oleic acid 2g, glyceryl glucoside 3g, 2,6-nonadienol 1g; Oil phase excipients: Vaseline 25g, lanolin 8g, beeswax 4g, liquid paraffin 10g; Emulsifier: Span-80 2g; Humectant: Glycerin 5g; Preservative: Ethylparaben 0.2g; Balance: Purified water (to bring to 100g).

[0064] Preparation method: After pulverizing the above-mentioned Chinese herbal medicines, the volatile oils were extracted by steam distillation. The residue was then boiled in water to obtain a concentrated decoction, which was then mixed to form a Chinese herbal medicine extract. Vaseline, lanolin, beeswax, liquid paraffin, and oleic acid were heated to 75°C to melt, and Span-80 and 2,6-nonadienol were added and stirred evenly to form an oil phase. Purified water, glycerol, and glycerol glucoside were heated to 70°C, and ethylparaben was added to dissolve them to form an aqueous phase. The aqueous phase was slowly added to the oil phase while stirring until emulsification was complete, and then the temperature was lowered to 45°C. The Chinese herbal medicine extract was then added and stirred rapidly to room temperature to obtain the final product.

[0065] Examples 4-8 and Comparative Examples 1-6: Transdermal Permeability Comparison Experiments of Ointments The transdermal penetration efficiency of magnolol (derived from Magnolia biondii) in the ointments of Examples 4-8 and Comparative Examples 1-6 was compared and quantified simultaneously to clarify the differential effects of the excipient combination azone, glyceryl glucoside, and 2,6-nonadienol on the transdermal absorption of the two core active ingredients, providing targeted data support for ointment formulation optimization.

[0066] Using the Franz diffusion cell method, the dorsal skin of nude mice (license number: SYXK(Shandong)20230023) was used as the transdermal model, and a steady-state environment at 32 °C was maintained. After the two active ingredients penetrated through the skin barrier and entered the receiving solution, the concentrations of the two ingredients in the receiving solution at different time points were quantitatively analyzed by high-performance liquid chromatography, the cumulative permeation amount was calculated, and the transdermal performance differences among groups were compared.

[0067] Table 4 Cumulative permeation amount Table 4 shows that the ointments of Examples 4-8 containing three excipients, azone, glucosyl glycerol, and 2,6-nonadienol, have significantly better transdermal penetration effects of the core active ingredients than the ointments of Comparative Examples 1-6.

Claims

1. A traditional Chinese medicine composition, characterized in that, The traditional Chinese medicine composition is made of the following traditional Chinese medicines: 5-15 parts by weight of Magnolia biondii, 4-10 parts by weight of Xanthium sibiricum, 4-10 parts by weight of Eupatorium fortunei, 4-10 parts by weight of Angelica dahurica, 5-15 parts by weight of Atractylodes lancea, 3-8 parts by weight of Acorus gramineus, 3-8 parts by weight of Scutellaria baicalensis, 3-8 parts by weight of Ligusticum chuanxiong, and 2-6 parts by weight of Mentha haplocalyx.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is made of the following traditional Chinese medicines: 10 parts by weight of Magnolia biondii, 6 parts by weight of Xanthium sibiricum, 6 parts by weight of Eupatorium fortunei, 6 parts by weight of Angelica dahurica, 10 parts by weight of Atractylodes lancea, 6 parts by weight of Acorus gramineus, 6 parts by weight of Scutellaria baicalensis, 6 parts by weight of Ligusticum chuanxiong, and 4 parts by weight of Mentha haplocalyx.

3. A paste comprising the traditional Chinese medicine composition of claim 1, characterized in that, The ointment further comprises azone, glycerol glucoside, 2,6-nonadienol, and pharmaceutically acceptable adjuvants.

4. The paste of claim 3, wherein The azone is 1.0-3.0 parts by weight, the glycerol glucoside is 2.0-4.0 parts by weight, and the 2,6-nonadienol is 0.5-1.5 parts by weight.

5. The paste of claim 3, wherein The pharmaceutically acceptable adjuvants are selected from the group consisting of bases, humectants, preservatives, thickening agents, stabilizers, neutralizing agents, pH adjusting agents, solvents, co-solvents, antioxidants, fragrances, skin conditioning agents, glidants, and chelating agents.

6. The paste of claim 3, wherein The pharmaceutically acceptable adjuvants are selected from the group consisting of petrolatum, lanolin, beeswax, shellac wax, liquid paraffin, vegetable oil, hydrogenated vegetable oil, stearic acid, glyceryl monostearate, PEG 400, PEG 6000, PEG 8000, carbomer, hydroxypropyl methylcellulose, sodium carboxymethylcellulose, sodium alginate, xanthan gum, stearyl alcohol, cetyl alcohol, octadecanol, polysorbates, Spans, polyoxyethylene hydrogenated castor oil, glycerol monostearate, sodium lauryl sulfate, sodium laureth sulfate, glycerol, propylene glycol, sorbitol, polyglyceryl-3, betaine, sodium hyaluronate, panthenol, trehalose, hydroxybenzoic esters, phenoxyethanol, chlorphenesin, benzalkonium chloride, benzalkonium bromide, sorbic acid, sodium dehydroacetate, menthol, guar gum, gum arabic, pectin, carrageenan, hydroxyethyl cellulose, methyl cellulose, sodium polyacrylate, silicon dioxide, bentonite, montmorillonite, triethanolamine, diethanolamine, ethanolamine, sodium hydroxide, potassium hydroxide, hydrochloric acid, citric acid, lactic acid, sodium dihydrogen phosphate, disodium hydrogen phosphate, acetic acid-sodium acetate buffer solution, ethanol, propylene glycol, water, glycerol, polyethylene glycol 400, dimethyl sulfoxide, dimethylformamide, glycerol, poloxamer, vitamin E, sodium bisulfite, sodium metabisulfite, sodium thiosulfate, butylated hydroxyanisole, butylated hydroxytoluene, propyl gallate, ascorbyl palmitate, peppermint oil, eucalyptus oil, lavender oil, lemon oil, rose oil, clove oil, cassia oil, dried tangerine or orange peel oil, citronella oil, ice chips, camphor, dipotassium glycyrrhizinate, allantoin, aloe extract, panthenol, ceramide, cholesterol, talc, micro-powder silica gel, magnesium stearate, disodium edetate, trisodium citrate.

7. Use of the traditional Chinese medicine composition of claim 1 in the preparation of a medicament for treating rhinitis.

8. Use of the traditional Chinese medicine composition of claim 1 in the preparation of a medicament for treating allergic rhinitis.

9. Use according to claim 7 or 8, characterized in that, The traditional Chinese medicine composition can improve symptoms such as rhinorrhea, nasal congestion, sneezing, nasal itching, ocular itching, lacrimation, and sleep disturbance. The traditional Chinese medicine composition can improve symptoms such as rhinorrhea, nasal congestion, sneezing, nasal itching, ocular itching, lacrimation, and sleep disturbance.

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