Traditional Chinese medicine composition capable of being inhaled by atomization as well as preparation method, detection method and application of traditional Chinese medicine composition

Abstract

The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition capable of being inhaled by atomization and a preparation method, a detection method and application thereof. The traditional Chinese medicine composition is prepared from the following components in parts by weight: 300 to 700 parts of blumea oil, 400 to 700 parts of fructus perillae oil and 10 to 35 parts of menthol. The traditional Chinese medicine composition is high in delivery rate, total delivery amount, fine particle dosage and fine particle proportion, most of the traditional Chinese medicine composition can directly reach the lung, and the traditional Chinese medicine composition can be used for aerosol inhalation, is good in atomization effect, meets clinical use requirements and can be used for treating lung diseases.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine compositions, and in particular to a traditional Chinese medicine composition capable of being atomized and inhaled, and a preparation method, a detection method and application thereof. Background Art

[0002] Respiratory diseases are common and frequently occurring clinical conditions, encompassing a wide range of conditions, including colds, coughs, asthma, bronchitis, and pneumonia, with their incidence rates increasing annually. Emphysema, chronic obstructive pulmonary disease (COPD), and lung adenocarcinoma are among the leading causes of death worldwide. According to the 2024 China Health Statistics Annual Inspection, the COPD prevalence among Chinese residents aged 40 and over reached 13.7% from 2012 to 2015. Data from the International Agency for Research on Cancer (IARC) GLOBCAN indicates that in 2022, there were 19.926 million new cases of malignant tumors and 9.744 million deaths worldwide. This demonstrates that despite the availability of advanced treatments, including oral and parenteral medications, surgery, and chemotherapy, these diseases still face significant public health challenges.

[0003] In recent years, nebulized inhalation therapy has been introduced into clinical practice. It is a drug delivery system that delivers drugs to the lungs, where they are absorbed locally or through the lungs for systemic effects. It is often used as an effective treatment for respiratory diseases. Compared to traditional drug delivery methods, nebulized inhalation offers significant advantages such as faster delivery, greater efficiency, greater convenience, improved safety, and improved patient compliance. It has become the preferred choice for treating respiratory diseases in special populations such as children, the elderly, and pregnant women.

[0004] However, the nebulized inhaled medications currently available on the market are primarily Western medicines, such as budesonide disclosed in Chinese Invention Patent Application No. CN201710613207.X, interferon disclosed in Chinese Invention Patent Application No. CN202410678338.6, and heat-killed Clostridium butyricum disclosed in Chinese Invention Patent Application No. CN202210299769.2. However, Western medicines have certain drawbacks in terms of drug resistance, safety, and therapeutic range. In contrast, nebulized Traditional Chinese Medicine (TCM) inhalation offers pharmacological advantages such as multi-target synergy, low risk of drug resistance, minimal side effects, and a wide range of applicable populations. Although there are some TCM nebulizers, such as those in Chinese Invention Patent Application Nos. CN201710423673.1, CN201710224568.5, and CN201710635477.0, their variety is relatively limited and they have not demonstrated significant efficacy in treating lung diseases. Summary of the Invention

[0005] The technical problem to be solved by the present invention is to provide a Chinese medicine composition that can be atomized and inhaled, and its preparation method, detection method and application, so as to prepare medicines for treating lung diseases.

[0006] In order to solve the above technical problems, the technical solution adopted by the present invention is: a traditional Chinese medicine composition that can be atomized and inhaled, comprising 300-700 parts of mugwort oil, 400-700 parts of perilla seed oil, and 10-35 parts of menthol, in parts by weight.

[0007] Another technical solution adopted by the present invention is: the preparation method of the above-mentioned traditional Chinese medicine composition that can be atomized and inhaled comprises the following steps: mixing mugwort oil, perilla seed oil and menthol uniformly according to weight to obtain the traditional Chinese medicine composition.

[0008] Another technical solution adopted by the present invention is: the detection method of the above-mentioned aerosol inhalable Chinese medicine composition comprises the following steps: preparing a mixed reference solution and a test solution, and then performing gas chromatography determination, wherein the mixed reference solution includes eucalyptol, camphor, β- Caryophyllene and menthol.

[0009] Another technical solution adopted by the present invention is: use of the above-mentioned atomized inhalable Chinese medicine composition in the preparation of medicines for treating lung diseases.

[0010] The beneficial effects of the present invention are that the delivery rate, total delivery amount, fine particle dosage, and fine particle ratio of the traditional Chinese medicine composition of the present invention are all high, most of them can reach the lungs directly, can be used for atomization inhalation, and have a good atomization effect, meet clinical use needs, and can be used to treat lung diseases. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] Figure 1 This is a gas chromatogram of Example 2 of the present invention; Figure 2 This is a gas chromatogram of Example 4 of the present invention under the programmed temperature conditions of 3.1; Figure 3 This is the mass spectrum of Example 4 of the present invention under the programmed temperature conditions of 3.1; Figure 4 This is a gas chromatogram of Example 4 of the present invention under the programmed temperature condition of 3.3; Figure 5 This is a gas chromatogram of Example 4 of the present invention under the programmed temperature condition of 3.4; Figure 6 This is a test chart of bioluminescence levels in each group after drug administration in Example 5 of the present invention; Figure 7 These are the histological anatomy diagrams of each group after drug administration in Example 5 of the present invention. DETAILED DESCRIPTION

[0012] To illustrate the technical content, achieved objectives and effects of the present invention in detail, the following description is given in conjunction with the embodiments and accompanying drawings.

[0013] A traditional Chinese medicine composition capable of being atomized and inhaled comprises, by weight, 300-700 parts of wormwood oil, 400-700 parts of perilla seed oil, and 10-35 parts of menthol.

[0014] A traditional Chinese medicine composition capable of being atomized and inhaled consists, in parts by weight, of 300-700 parts of wormwood leaf oil, 400-700 parts of perilla seed oil and 10-35 parts of menthol.

[0015] From the above description, it can be seen that the beneficial effects of the present invention are: the traditional Chinese medicine composition of the present invention can directly enter the lungs to exert multi-target therapeutic effects, maximize the efficacy through modern analytical technology, and has the characteristics of high concentration, small dosage, and high inhalation rate. It significantly improves the patient's compliance and meets the needs of clinical use. It can be used for aerosol inhalation to prepare drugs for the treatment of lung diseases such as pneumonia, emphysema, and lung cancer.

[0016] In the Chinese medicine composition of the present invention, the efficacy of each Chinese medicine flavor is as follows: Artemisia argyi oil: Artemisia argyi ( Artemisia argyi The volatile oil from the dried leaves of the genus Levl. et Vant. is used to warm the meridians and stop bleeding, dispel cold and relieve pain; and externally, it can dispel dampness and relieve itching. It is used for hematemesis, epistaxis, metrorrhagia, menorrhagia, menorrhagia, lower abdominal cold pain, irregular menstruation due to cold, and infertility due to uterine coldness; and externally, it can treat skin itching.

[0017] Perilla seed oil: from the Lamiaceae plant Perilla ( Perilla frutescens A highly unsaturated natural oil obtained from the mature seeds of the genus L. Britt. Its main functions include lowering qi and resolving phlegm, relieving cough and asthma, and moistening the intestines and promoting bowel movements. It is used for phlegm accumulation, qi stagnation, cough and asthma, and constipation caused by dry intestines.

[0018] Menthol: a mint plant of the Lamiaceae family ( Mentha haplocalyx A saturated cyclic alcohol obtained by steam distillation, freezing, and recrystallization of the fresh stems and leaves of the plant (Briquette Briq.). Its primary functions include cooling and relieving itching; internally, it can be used as a carminative for headaches and inflammation of the nose, pharynx, and throat.

[0019] Traditional Chinese Medicine Explanation: Mugwort oil warms the meridians, dispels cold, resolves phlegm and relieves coughs, and has antibacterial and anti-inflammatory properties. It serves as the main ingredient, improving airway spasms and the inflammatory microenvironment associated with lung infections. Perilla seed oil, as the assistant ingredient, lowers Qi and resolves phlegm, relieves cough and asthma, moistens the lungs and disperses stagnation. It promotes phlegm dilution and excretion, alleviates airway obstruction, and combats fibrosis. Menthol, as the adjuvant ingredient, dispels wind and heat, relieves sore throat, relieves spasms and relieves pain, harmonizing the medicinal properties. These three ingredients work together to regulate the ascending and descending flow of Qi and restore the lung's function of dispersing and descending.

[0020] The present invention combines mugwort oil, perilla seed oil and menthol, and the combined effect produces an effect that is greater than the sum of its parts. The efficacy of a single component is relatively limited. In the present invention, mugwort oil mainly exerts antibacterial, anti-inflammatory and meridian-warming and cold-dispersing effects; perilla seed oil focuses on antioxidant effects; and menthol focuses on cooling and analgesic effects, and promoting skin / mucous membrane penetration. After combination, the three synergistically exert the "antibacterial-anti-inflammatory-penetration-promoting-soothing" effects, achieving complementary and enhanced efficacy. Secondly, mugwort oil alone is easily oxidized and deteriorated, the unsaturated fatty acids in perilla seed oil are easily decomposed by light / heat, and menthol is highly volatile. After combination, the antioxidant components of perilla seed oil can slow down the oxidation rate of mugwort oil; the volatility of menthol is wrapped by the oil matrix of mugwort oil and perilla seed oil, reducing volatilization losses and achieving improved stability of each component.

[0021] Preferably, the invention comprises 500-600 parts of wormwood oil, 500-600 parts of perilla seed oil and 20-30 parts of menthol in parts by weight.

[0022] Furthermore, the content of eucalyptol in the traditional Chinese medicine composition is ≥4.5wt%, the content of camphor is ≥3.7wt%, β- Caryophyllene content ≥1.7wt%, menthol content ≥2.1wt%, α- Linolenic acid content ≥52.0wt%.

[0023] From the above description, we can see that eucalyptol, camphor and β- Caryophyllene and thuja oil affect the antibacterial and anti-inflammatory effects. If the content is low, the antibacterial and anti-inflammatory effects will be insufficient and the expected effects will not be achieved. α- Linolenic acid has antioxidant properties, but if its content is reduced, its antioxidant capacity is weakened, making it unable to effectively protect the stability of mugwort oil and menthol, and the system is prone to deterioration. Low menthol content leads to weak transdermal enhancement and a lack of significant cooling and analgesic effects. In summary, only within the above content range can the three ingredients achieve a balanced antibacterial, anti-inflammatory, and transdermal performance, improving stability and bioavailability.

[0024] Another technical solution adopted by the present invention is: the preparation method of the above-mentioned traditional Chinese medicine composition that can be atomized and inhaled comprises the following steps: mixing mugwort oil, perilla seed oil and menthol uniformly according to weight to obtain the traditional Chinese medicine composition.

[0025] Furthermore, the preparation method of mugwort oil is: crushing mugwort, performing water distillation extraction, and obtaining mugwort oil.

[0026] Furthermore, the preparation method of perilla seed oil is: crushing perilla seeds and then cold pressing to obtain perilla seed oil.

[0027] From the above description, we can see that the leaching method requires the use of organic solvents for extraction, which is prone to safety risks such as organic solvent residues; the distillation method will directly destroyα- The unsaturated bond of linolenic acid leads to a large degree of inactivation of the active ingredient and a low yield; while the cold pressing method can retain the active ingredient to a large extent through physical pressing. α- Therefore, the perilla seeds of the present invention are cold pressed instead of extracted or distilled. Cold pressed is the best choice to ensure that the active ingredients of perilla seed oil are not destroyed, and the safety and process feasibility are guaranteed.

[0028] Furthermore, the cold pressing temperature is below 100° C., and the extraction time is 40 to 60 minutes.

[0029] Another technical solution adopted by the present invention is: the detection method of the above-mentioned Chinese medicine composition that can be atomized and inhaled comprises the following steps: preparing a mixed reference solution and a test solution, and then performing gas chromatography determination, wherein the mixed reference solution includes eucalyptol, camphor, β- Caryophyllene and menthol.

[0030] From the above description, it can be seen that according to the quality standard of Artemisia argyi in the 2025 edition of the Chinese Pharmacopoeia, only eucalyptol and borneol can be determined, and the multiple components of this compound cannot be determined. Therefore, the present invention provides a quantitative detection method for determining the multiple components of the above-mentioned traditional Chinese medicine composition, using gas chromatography to simultaneously determine the eucalyptol, camphor, β- The contents of four volatile active ingredients, including caryophyllene and menthol, can effectively reflect and control the quality information of the aerosol inhalation product.

[0031] Furthermore, the test solution used ethyl acetate-95% ethanol as the extraction solvent, with 95% as the volume fraction and the volume ratio of ethyl acetate to 95% ethanol being 1:1~2.

[0032] From the above description, it can be seen that ethyl acetate-95% ethanol (1:1~2) can completely dissolve the sample.

[0033] Furthermore, the column temperature of the gas chromatograph is programmed.

[0034] Furthermore, the initial column temperature of the gas chromatograph was 60°C and maintained for 1 min; the temperature was first increased to 75°C at a rate of 1°C per minute and maintained for 3 min; the temperature was then increased to 90°C at a rate of 3°C per minute; the temperature was then increased to 125°C at a rate of 1°C per minute and maintained for 1.5 min; the temperature was then increased to 149°C at a rate of 10°C per minute; and finally the temperature was increased to 250°C at a rate of 10°C per minute and maintained for 5 min.

[0035] From the above description, it can be seen that under the specific programmed temperature conditions of the present invention, the separation degree of eucalyptol peak is as high as 3.1, and camphor, β- There are no other interfering peaks at the caryophyllene and menthol peaks, and the separation degrees are greater than 2.5, indicating the best separation effect.

[0036] Another technical solution adopted by the present invention is: use of the above-mentioned atomized inhalable Chinese medicine composition in the preparation of medicines for treating lung diseases.

[0037] Furthermore, the disease is at least one of pneumonia, emphysema and lung cancer.

[0038] Embodiment 1 of the present invention is: a traditional Chinese medicine composition that can be atomized and inhaled, composed of the following raw materials in parts by weight: 400 parts of mugwort oil, 600 parts of perilla seed oil, and 20 parts of menthol.

[0039] The second embodiment of the present invention is a method for preparing a Chinese medicine composition that can be atomized and inhaled, and the specific steps are as follows: S1: chop the mugwort leaves into small pieces and extract them by hydrodistillation using 10 times the weight of the mugwort leaves of water. The extraction times are 1 and the extraction time is 3 hours to obtain mugwort oil. The perilla seeds are crushed and then cold-pressed for 40 to 60 minutes at a temperature below 100°C to obtain perilla seed oil.

[0040] S2: 40 g of mugwort oil, 60 g of perilla seed oil and 2 g of menthol were mixed evenly to obtain a Chinese herbal oily mixed extract.

[0041] S3: Filter and sterilize the mixed oily extract of the traditional Chinese medicine to obtain a traditional Chinese medicine composition that can be atomized and inhaled.

[0042] The Chinese medicine composition prepared in Example 2 was subjected to a nebulized inhalation test, and the specific test results are as follows: Delivery rate and total delivery amount: determined according to the method of the Chinese Pharmacopoeia (2025 edition).

[0043] Fine particle dosage: Check according to the method for determining the aerodynamic characteristics of fine particles of inhalation preparations (General Rule 0951) in the Chinese Pharmacopoeia (2025 edition).

[0044] Three batches of TCM composition samples were taken to measure parameters such as delivery rate, total delivery amount, fine particle dose and fine particle ratio. The results are shown in Table 1.

[0045] Table 1

[0046] As can be seen from Table 1, the present invention measured the relevant atomization parameters of the traditional Chinese medicine composition in accordance with the "Chinese Pharmacopoeia". The delivery rate, total delivery amount, fine particle dose, and fine particle ratio of the traditional Chinese medicine composition are all high. Most of them (78%) can reach the lungs directly, indicating that the product has good inhalation performance and atomization effect as an aerosol inhalation preparation, can meet clinical use requirements, and can be used to treat lung diseases.

[0047] The third embodiment of the present invention is a method for detecting the Chinese medicine composition prepared in the second embodiment, and the specific steps are as follows: 1. Solution Preparation 1.1 Reference substance stock solution: Accurately weigh 20 mg of eucalyptol reference substance, 30 mg of camphor reference substance, β -Clove ene reference substance 10mg, menthol reference substance 30mg, were placed in 10mL volumetric flasks, ethyl acetate was added to dissolve and the volume was adjusted to the scale, and the mass concentrations of eucalyptol, camphor, and menthol were 2, 3, 1, and 3mg / mL respectively. β -Caryophyllene and menthol reference substance stock solution.

[0048] 1.2 Mixed reference solution: Accurately pipette eucalyptol, camphor, β - Place 1 mL each of caryophyllene and menthol reference substance stock solutions in the same 10 mL volumetric flask, dilute with ethyl acetate and adjust to the mark to obtain mixed reference substance solutions with component concentrations of 0.2, 0.3, 0.1, and 0.3 mg / mL, respectively. Store in a 4°C refrigerator for later use.

[0049] 1.3 Preparation of Test Solution: Weigh 0.4 g of the TCM composition sample into a 50 mL volumetric flask. Dissolve and dilute with ethyl acetate-95% ethanol (1:2) to the mark. Filter through a 0.22 μm organic phase microporous membrane and collect the filtrate.

[0050] 2. The gas chromatography method was used for determination. The gas chromatography conditions were as follows: The chromatographic column was DM-Wax (30.0 m × 0.25 mm × 0.25 μm); the column temperature was programmed: initial temperature 60 °C, held for 1 min; first, the temperature was increased to 75 °C at a rate of 1 °C per minute and held for 3 min; then, the temperature was increased to 90 °C at a rate of 3 °C per minute; then, the temperature was increased to 125 °C at a rate of 1 °C per minute and held for 1.5 min; then, the temperature was increased to 149 °C at a rate of 10 °C per minute; finally, the temperature was increased to 250 °C at a rate of 10 °C per minute and held for 5 min; split injection, split ratio: 10:1; injection port temperature: 240 °C; FID detector temperature: 250 °C; FID detector, nitrogen flow rate: 10 mL / min; injection volume: 1 μL.

[0051] 3. Methodological investigation of the above detection methods 3.1 Specificity test Under the above chromatographic conditions, blank solution, mixed reference solution and test solution were injected. The results showed that eucalyptol, camphor, β-The retention time of the chromatographic peaks of caryophyllene, menthol and the reference solution is consistent and the peak shape is symmetrical. The theoretical plate number is not less than 10,000, the separation degree is greater than 2.5, and there is no interference in the blank solution chromatogram, indicating that the method has good specificity. Figure 1 .

[0052] 3.2 System suitability test Take the mixed reference solution and inject it 6 times continuously according to the chromatographic conditions. Calculate the RSD value of the peak area of ​​each chromatographic peak of the 6 injections of mixed reference solution. β The RSD values ​​for the peak areas of caryophyllene and menthol were 0.5%, 0.6%, 0.9%, and 0.4%, respectively, indicating good instrument precision. (See Table 2.)

[0053] Table 2

[0054] 3.3 Repeatability test Six samples were prepared in parallel according to the test solution preparation method, and the samples were analyzed according to the above chromatographic conditions. The RSD values ​​of the four reference substances in the six test samples were calculated. β The RSD values ​​for caryophyllene and menthol were 0.6%, 0.9%, 1.7%, and 1.8%, respectively, indicating good reproducibility of the method (see Table 3).

[0055] Table 3

[0056] 3.4 Stability test Take the test solution and place it at room temperature for 0, 2, 4, 8, 12, and 24 hours, and inject the sample according to the above chromatographic conditions to calculate the RSD value of the peak area of ​​the four reference substances in the sample. β The RSD values ​​of the peak areas of -caryophyllene and menthol were 0.9%, 1.2%, 1.6%, and 1.4%, respectively, indicating that the test solution had good stability at room temperature for 24 hours. See Table 4.

[0057] Table 4

[0058] 3.5 Linearity test Accurately measure 0.1, 0.5, 1.0, 1.5, 2.0, and 2.5 mL of the mixed reference solution and place them in 10 mL volumetric flasks, accurately add ethyl acetate to dilute to a series of concentrations of reference solution, and inject the sample in sequence according to the chromatographic conditions. βStandard curves were drawn using the concentration (X) (mg / mL) of the caryophyllene and menthol reference solutions as the horizontal axis and the peak area (Y) as the vertical axis. The results showed that the standard curve for eucalyptol in the concentration range of 0.0169-0.4213 mg / mL was Y=1447.3X+0.0003, r=0.9997; the standard curve for camphor in the concentration range of 0.0285-0.7125 mg / mL was Y=1515.3X+0.9035, r=0.9997. β The standard curve of -caryophyllene in the concentration range of 0.0086-0.2154 mg / mL is Y=1668.9X-1.3317, r=0.9997; the standard curve of menthol in the concentration range of 0.0228-0.5707 mg / mL is Y=1558.4X-1.4674, r=0.9997; in summary, the four have good linearity within a certain mass concentration range.

[0059] 3.6 Sample recovery test Take about 0.2g of the Chinese medicine composition sample with known component content, a total of 6 parts, accurately weighed, added an appropriate amount of mixed reference solution, prepared the sample according to the test solution preparation method, and injected the sample for determination. β The average recoveries of caryophyllene and menthol were 100.6%, 99.6%, 103.3%, and 97.0%, respectively, with RSDs of 1.6%, 1.8%, 1.0%, and 1.0%, respectively. These all met the requirements, demonstrating that the GC method was feasible. (See Table 5.)

[0060] Table 5

[0061] 4. Content Determination Take the Chinese medicine composition (3 batches) in Example 2, prepare the test solution according to the above solution preparation method, and then inject the sample according to the established chromatographic conditions for determination, and calculate the content of each component by external standard method. At the same time, according to the national food safety standard method (code: GB 5009.168-2016), the content of each component in the prescription was quantified. α- The results showed that the content of linolenic acid in 3 batches of samples was 1. β - Caryophyllene, menthol, α- The average linolenic acid content was 4.65%, 3.72%, 1.74%, 2.17%, and 52.78%, respectively. The RSDs for each indicator component were all less than 2.0%, indicating that the content differences between different batches of samples within the same shelf life were small, providing data support for stable clinical efficacy. (See Table 6).

[0062] Table 6

[0063] The fourth embodiment of the present invention is: performing parameter selection on the detection method of the third embodiment.

[0064] 1. Selection of sample extraction solvent The Chinese medicine composition was dissolved in methanol, 95% ethanol, ethyl acetate, ethyl acetate-methanol (1:1), and ethyl acetate-95% ethanol (1:1) solvents. Results showed that methanol and 95% ethanol were completely insoluble, while ethyl acetate-methanol (1:1) incompletely dissolved the composition. Ethyl acetate and ethyl acetate-95% ethanol (1:1) both completely dissolved the composition, demonstrating good results and suitable for use as extraction solvents. However, because ethyl acetate is corrosive to polyethylene and has a pungent odor, ethyl acetate-95% ethanol (1:1) was preferred as the extraction solvent.

[0065] 2. Selection of extraction solvent ratio The dissolution effects of the traditional Chinese medicine composition using three solvent ratios (1:1, 1:2, and 1:3) of ethyl acetate and 95% ethanol were investigated. The results showed that 1:3 ethyl acetate and 95% ethanol did not completely dissolve the sample, with oily droplets visible at the sample interface. However, 1:1 and 1:2 ethyl acetate and 95% ethanol completely dissolved the sample, demonstrating excellent results. However, because ethyl acetate is corrosive to polyethylene and has a pungent smell, a 1:2 ratio of ethyl acetate to 95% ethanol was preferred for extraction.

[0066] 3. Optimization of the heating program 3.1 Based on the literature, this study initially used a heating program set as follows: 90°C, then increased to 140°C at a rate of 1°C / min, held for 2 minutes; and finally increased to 200°C at a rate of 20°C / min, held for 5 minutes. Under these conditions, eucalyptus oil was not separated from the front peak; menthol achieved the best separation, with a clear peak shape, no fronting or tailing, a resolution greater than 2.5, and a theoretical plate number greater than 5000; see [1]. Figure 2 .

[0067] 3.2 Mass spectrometry identification was performed based on the test in 3.1. The results are shown in Table 7 and Figure 3 .

[0068] Table 7

[0069] 3.3 Based on the literature research and the test results of 3.1 and 3.2, the peak shape optimization and peak identification of the mixed solution prepared according to the prescription were carried out. The initial temperature was set at 90°C; first, the temperature was increased to 100°C at a rate of 1°C per minute and maintained for 2.5 minutes; then, the temperature was increased to 115°C at a rate of 3°C per minute; then, the temperature was increased to 125°C at a rate of 1°C per minute and maintained for 2 minutes; then, the temperature was increased to 149°C at a rate of 3°C per minute and maintained for 1.4 minutes; finally, the temperature was increased to 250°C at a rate of 10°C per minute and maintained for 6 minutes. The results showed that a total of 10 reference substances were added, and 7 were detected (limonene, eucalyptol, (-)- α -Thujone, camphor, β - caryophyllene, menthol, borneol), 3 were not detected ( α -Methyl linolenate, perillaldehyde, perillyl alcohol). The peak shape of eucalyptol was improved, and the separation degree reached 1.7; camphor, β -Clove ene and menthol have good peak shape, no other interference peaks, and the separation degree is greater than 1.5. β - Caryophyllene and menthol have high contents. In summary, these four components are defined as index components in this experiment. Figure 4 .

[0070] 3.4 Based on 3.3, in order to better separate eucalyptol from adjacent components, the peak shape of the T18 mixed solution was optimized again. The initial temperature was set at 60°C; the temperature was first increased to 75°C at a rate of 1°C per minute and maintained for 3 minutes; then the temperature was increased to 90°C at a rate of 3°C per minute; then the temperature was increased to 125°C at a rate of 1°C per minute and maintained for 1.5 minutes; then the temperature was increased to 149°C at a rate of 10°C per minute; finally, the temperature was increased to 250°C at a rate of 10°C per minute and maintained for 5 minutes. The results showed that the peak separation of eucalyptol was as high as 3.1, and camphor, β There are no other interfering peaks at the -caryophyllene and menthol peaks, and the separation degree is greater than 2.5. Figure 5 In summary, this temperature rising parameter is used as the analysis method of gas chromatography.

[0071] Comparative Example 1 of the present invention is: The difference between Comparative Example 1 and Example 2 is only that: there is no wormwood oil.

[0072] Comparative Example 2 of the present invention is: The difference between Comparative Example 2 and Example 2 is only that: perilla seed oil.

[0073] Comparative Example 3 of the present invention is: The difference between Comparative Example 3 and Example 2 is only that: menthol.

[0074] Example 5 of the present invention is: using the pharmaceutical composition of Example 2 and Comparative Examples 1 to 3 to treat lung cancer.

[0075] 1. Experimental Design 1.1 Drug preparation Different concentration gradients were formulated based on the properties of the prescribed drug, including a blank control (PBS group), a low-dose group (Low), a high-dose group (High), a traditional Chinese medicine control group (Fufang Banqiao Capsule), and a chemical drug group (paclitaxel). Male mice were divided into five groups of five each and administered according to the drug's instructions by inhalation. Treatment lasted 18 days, with a three-day interval. The corresponding dosing methods and doses were as follows: Low group, 5 μL / mouse / 3 days (1 dose per human equivalent). High group, maximum dose, 2 μL / mouse / 3 days (2 doses per human equivalent). Fufang Banqiao Capsule group, 1.2 mg / mouse / 3 days (1 dose per human equivalent), administered by oral gavage. Paclitaxel, 200 μg / mouse / 3 days (1 dose per human equivalent).

[0076] 1.2 Model Building 1.2.1 A549 cell recovery, culture, and passaging Take the cultured A549 cells, discard the culture medium after the density reaches 80% under the microscope, and wash with PBS. Add trypsin to digest at 37℃. After the cells become round, add culture medium to stop digestion, blow off the cells, and centrifuge at 1500rpm for 5 minutes. Discard the supernatant, resuspend the cells, and divide them into new culture dishes containing culture medium and culture at 37℃. Take A549-Luc cells that have grown to 80%, wash with PBS, add trypsin to digest at room temperature for 3 minutes until the cells become round, add culture medium to stop digestion, blow off the cells, and centrifuge at 1500rpm for 5 minutes. Discard the supernatant and resuspend in serum-free culture medium. Mix the diluted cells with Matrigel at a ratio of 1:1 to prepare the cell suspension for modeling.

[0077] 1.2.2 Animal model establishment First, pipette 100µL of the prepared cell suspension into a pre-chilled insulin syringe (pre-bend the tip 3mm for injection). Then, anesthetize and immobilize the mouse. Place the mouse in a sealed anesthesia induction chamber and administer a 3%-5% isoflurane-oxygen mixture (flow rate 0.8-1.5 L / min) for approximately 1-2 minutes until the mouse loses its righting reflex (manifested by lateral recumbency and inability to turn over voluntarily). Transfer the mouse to a heated operating table and maintain anesthesia with 1%-2% isoflurane via a nose cone. Monitor the mouse's respiratory rate (approximately 50-100 breaths / minute) and the absence of pain to ensure the appropriate depth of anesthesia. For positioning, apply iodine-based disinfectant at the junction of the mouse's left ear margin and 1 cm below the left posterior axillary line. Use surgical scissors to make a transverse incision of approximately 0.5 cm in the skin, exposing the white-pink solid left lung tissue, contrasting with the surrounding dark red cardiac tissue. After positioning, insert the insulin syringe into the left lung to a depth of 3 mm. Pause for 5–10 seconds after injection and suture the incision with one or two stitches. Finally, apply iodine to the sutured wound again to prevent infection. The model is complete. Repeat the above steps to complete the modeling of all mice. Mark the mice accordingly, place them in individual cages, and observe their subsequent condition.

[0078] 1.2.3 Effect evaluation Day 0 was the first day of dosing, and the formation and progression of lung tumors in mice were monitored regularly every three days. Each mouse was intraperitoneally injected with 0.2 mL of luciferin solution (1.5 mg / mL) and immediately placed in a sealed anesthesia induction chamber for 5 minutes with a 5% isoflurane-oxygen mixture. After anesthesia, the mice were photographed sequentially using a bioluminescence small animal imaging system (Caliper IVIS Lumina II) to measure and record their bioluminescence. After treatment, the mice were dissected, and their major tissues were removed and photographed. Fixed lung tissues from each group were analyzed by H&E staining, and the extent of lung tissue damage was analyzed using quantitative software data. These two factors were combined to assess the tumor inhibitory effect of the drug and to systematically evaluate its anti-lung cancer efficacy.

[0079] 2. Results and Conclusions 2.1 Bioluminescence During the observation period, the bioluminescence of mice in the PBS group increased by nearly 15 to 20 times, and some mice died. The bioluminescence of the capsule group increased by nearly 10 to 15 times, with a similar trend to the PBS group. The bioluminescence of the paclitaxel group showed a slow upward trend from 0 to 12 days, but decreased significantly on days 15 and 18, suggesting that paclitaxel has a certain therapeutic effect. The bioluminescence of the Low group increased at a slow rate. The bioluminescence of the High group was significantly lower than that of the other groups, and its effect was better than that of the paclitaxel and Low groups. Figure 6 .

[0080] In summary, the bioluminescence changes in the PBS and capsule groups showed a consistent trend, both showing a continuous upward trend over time; while the bioluminescence in the paclitaxel group and the prescription drug group was significantly lower than that in the PBS group, indicating that the prescription had an inhibitory effect on the growth of lung cancer cells.

[0081] 2.2 Tissue anatomy The results showed that the PBS group had the largest lung tumor volume observed with the naked eye, and was accompanied by obvious heart and liver metastases; the capsule group had a larger lung tumor volume, with slight heart and liver metastases; the paclitaxel group had a larger lung tumor volume, with only liver metastases; the Low group had smaller lung tumor tissue, with no signs of heart or liver metastases observed with the naked eye; the High group had significantly smaller lung tumor tissue; and a healthy group was also treated with the same dosage and method as the High group, and drug retention was observed in their lungs. Figure 7 .

[0082] In summary, from an anatomical perspective, the lung tumors in the Low and High groups were smaller and showed no tissue metastasis. This indicates that the prescription can effectively inhibit tumor growth and block tumor metastasis, demonstrating significant anti-lung cancer efficacy.

[0083] The sixth embodiment of the present invention is: a traditional Chinese medicine composition that can be used for atomization inhalation, composed of the following raw materials in parts by weight: 300 parts of mugwort oil, 400 parts of perilla seed oil, and 10 parts of menthol.

[0084] Embodiment 7 of the present invention is: a traditional Chinese medicine composition that can be used for atomization inhalation, composed of the following raw materials in parts by weight: 700 parts of mugwort oil, 700 parts of perilla seed oil, and 35 parts of menthol.

[0085] Embodiment 8 of the present invention is: a traditional Chinese medicine composition that can be used for atomization inhalation, composed of the following raw materials in parts by weight: 500 parts of mugwort oil, 550 parts of perilla seed oil, and 16 parts of menthol.

[0086] Embodiment 9 of the present invention is: a traditional Chinese medicine composition that can be used for atomization inhalation, composed of the following raw materials in parts by weight: 600 parts of mugwort oil, 480 parts of perilla seed oil, and 27 parts of menthol.

[0087] The tenth embodiment of the present invention is a method for preparing a Chinese medicine composition that can be atomized and inhaled, and the specific steps are as follows: S1: chop the mugwort leaves into small pieces and extract them by hydrodistillation using 10 times the weight of the mugwort leaves of water. The extraction times are 1 and the extraction time is 3 hours to obtain mugwort oil. The perilla seeds were crushed and then cold-pressed at 90°C for 40 minutes to obtain perilla seed oil.

[0088] S2: 40 g of mugwort oil, 60 g of perilla seed oil and 2 g of menthol were mixed evenly to obtain a Chinese herbal oily mixed extract.

[0089] S3: Filter and sterilize the mixed oily extract of the traditional Chinese medicine to obtain a traditional Chinese medicine composition that can be atomized and inhaled.

[0090] The eleventh embodiment of the present invention is a method for preparing a Chinese medicine composition that can be atomized and inhaled, and the specific steps are as follows: S1: chop the mugwort leaves into small pieces and extract them by hydrodistillation using 10 times the weight of the mugwort leaves of water. The extraction times are 1 and the extraction time is 3 hours to obtain mugwort oil. The perilla seeds were crushed and then cold pressed at 80°C for 60 min to obtain perilla seed oil.

[0091] S2: 40 g of mugwort oil, 60 g of perilla seed oil and 2 g of menthol were mixed evenly to obtain a Chinese herbal oily mixed extract.

[0092] S3: Filter and sterilize the mixed oily extract of the traditional Chinese medicine to obtain a traditional Chinese medicine composition that can be atomized and inhaled.

[0093] The twelfth embodiment of the present invention is: use of the atomized inhalable Chinese medicine composition of the second embodiment in preparing medicines for treating pneumonia, emphysema and lung cancer.

[0094] In summary, the aerosol inhalable Chinese medicine composition provided by the present invention, as well as its preparation method, detection method, and application, have the following advantages: 1. The Chinese medicine composition of the present invention can directly enter the lungs to exert multi-target therapeutic effects, and can be used for aerosol inhalation to prepare medicines for treating lung diseases such as pneumonia, emphysema, and lung cancer.

[0095] 2. The Chinese medicine composition of the present invention synergistically exerts the "antibacterial-anti-inflammatory-penetration-promoting-soothing" effects through mugwort oil, perilla seed oil and menthol, achieving complementary and enhanced effects.

[0096] 3. The Chinese medicine composition of the present invention has complex ingredients, and the programmed temperature test has a better effect, and the trace volatile components are suitable for split injection.

[0097] 4. The gas chromatography method of the present invention has good specificity, system applicability, stability, repeatability, linearity and accuracy, and can be comprehensively and accurately used for the content determination and quality control of multiple volatile index components in the traditional Chinese medicine composition, ensuring the safety and effectiveness of the traditional Chinese medicine composition.

[0098] The above descriptions are merely embodiments of the present invention and are not intended to limit the patent scope of the present invention. Any equivalent transformations made using the contents of the present invention's description and drawings, or directly or indirectly applied in related technical fields, are also included in the patent protection scope of the present invention.

Claims

1. A Chinese medicine composition capable of aerosol inhalation, characterized in that: The invention comprises, by weight, 300-700 parts of wormwood oil, 400-700 parts of perilla seed oil and 10-35 parts of menthol.

2. The Chinese medicine composition capable of atomization inhalation according to claim 1, characterized in that: The content of eucalyptol in the traditional Chinese medicine composition is ≥4.5wt%, and the content of camphor is ≥3.7wt%. β - caryophyllene content ≥1.7wt%, menthol content ≥2.1wt%, α- Linolenic acid content ≥52.0wt%.

3. The method for preparing the atomized inhalable Chinese medicine composition according to claim 1 or 2, wherein: The following steps are involved: The wormwood leaf oil, perilla seed oil and menthol are uniformly mixed according to parts by weight to obtain a traditional Chinese medicine composition.

4. The method for preparing the atomized inhalable Chinese medicine composition according to claim 3, wherein: The preparation method of the mugwort leaf oil comprises the following steps: crushing the mugwort leaves, performing water distillation extraction, and obtaining the mugwort leaf oil.

5. The method for preparing the atomized inhalable Chinese medicine composition according to claim 3, wherein: The preparation method of the perilla seed oil comprises the following steps: crushing the perilla seeds and then cold pressing the perilla seeds to obtain the perilla seed oil.

6. The method for preparing the atomized inhalable Chinese medicine composition according to claim 5, characterized in that: The temperature of the cold pressing is below 100°C.

7. The method for detecting the aerosol inhalable Chinese medicine composition according to claim 1 or 2, wherein: The following steps are involved: Prepare a mixed reference solution and a test solution, and then perform gas chromatography determination. The mixed reference solution includes eucalyptol, camphor, β - Caryophyllene and menthol.

8. The method for detecting the aerosol inhalable Chinese medicine composition according to claim 7, wherein: The column temperature of the gas chromatograph is programmed.

9. Use of the aerosol inhalable Chinese medicine composition according to claim 1 or 2 in the preparation of medicines for treating lung diseases.

10. The use according to claim 9, characterized in that The disease is at least one of pneumonia, emphysema and lung cancer.

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