A Traditional Chinese Medicine Sachet Formula for Smoking Cessation and Its Application

Abstract

This invention relates to a traditional Chinese medicine formula for smoking cessation, the traditional Chinese medicine composition being made from the following raw materials in the indicated weight proportions: 20-60 parts of patchouli, 2-18 parts of cinnamon, 2-18 parts of fennel, 2-18 parts of agarwood, 2-18 parts of peppermint, 2-18 parts of clove, 2-18 parts of magnolia flower, 2-18 parts of atractylodes, 2-18 parts of borneol, 2-18 parts of houttuynia cordata, 2-18 parts of bitter orange flower, and 2-18 parts of styrax. Its advantages are as follows: The herbal composition of this invention is formulated by carefully selecting drugs under the guidance of traditional Chinese medicine theory and clinical experience; the drug components are combined according to the syndrome differentiation and complement each other in terms of their effects. The combination of each drug conforms to the principle of "principal, assistant, adjuvant and guide", and together they achieve the effects of soothing the liver and regulating qi, nourishing essence and blood, promoting qi circulation and relieving depression, and clearing the heart and relieving irritability. It can treat both the symptoms and the root cause of smoking addiction. Moreover, it has been proven by experiments that it can significantly alleviate respiratory inflammation in smoking model rats by reducing the content of airway inflammatory factors TNF-α, IL-6 and IL-1β, and at the same time, it has a significant expectorant effect on smoking rats.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a traditional Chinese medicine sachet formula for smoking cessation and its application. Background Technology

[0002] Tobacco dependence is a chronic disease caused by smoking addiction, essentially nicotine dependence. Its International Classification of Diseases (ICD-10) code is F17.2. Studies have found that tobacco contains over 7,000 chemical components, of which at least 100 are harmful to health, and approximately 70... Smoking can cause cancer; scientific evidence has confirmed that exposure to tobacco smoke can damage numerous organs and tissues in the human body, including the respiratory, cardiovascular, neuromuscular, endocrine, and digestive systems. Smoking can lead to disease and even death. Regarding the respiratory system, tobacco smoke enters the body through the respiratory tract and can accumulate in the airways and lungs, leading to various diseases. Chronic obstructive pulmonary disease (COPD) and lung cancer are most closely related to smoking, followed by tuberculosis and other respiratory infections. Tobacco smoke can also cause or induce pulmonary fibrosis and bronchial asthma. Quitting smoking has become a hot topic today. Modern medicine recommends smoking cessation medications such as nicotine preparations, varenicline, and bupropion, but these can cause adverse reactions. Varenicline may alter how people react to alcohol, and it is expensive, has significant side effects, and a high relapse rate. In China, people trying to quit smoking do not fully accept Western medicine for this purpose, and many are seeking traditional Chinese medicine to help them quit.

[0003] Because tobacco dependence is a chronic, addictive disease, the withdrawal symptoms are severe, the relapse rate is high, and repeated interventions and multiple attempts to quit smoking are often required during the smoking cessation process. Therefore, reducing nicotine dependence and psychological addiction is of great significance for reducing relapse and quitting tobacco. A review of recent research on nicotine dependence treatment reveals the following challenging issues in drug treatment for this disease, both domestically and internationally:

[0004] (1) Most previous studies on nicotine dependence have focused on improving withdrawal symptoms after reducing or stopping smoking, while there have been few studies on reducing psychological cravings, consolidating the therapeutic effect, maintaining the withdrawal state, and preventing relapse.

[0005] (2) Although there are many alternative smoking cessation methods available, such as e-cigarettes, chewing tablets, nicotine transdermal patches, and bupropion, which can replace or improve smoking dependence to a certain extent, their sustainability is poor and patients often relapse after stopping use.

[0006] (3) Traditional Chinese medicine has accumulated a lot of clinical data in the intervention of tobacco dependence. Significant clinical efficacy has been achieved by using traditional Chinese medicine therapies, especially external treatments. The commonly used external treatments for smoking cessation in clinical practice are mainly acupuncture, auricular acupressure, acupoint application, etc. Acupuncture, auricular acupressure, and acupoint application require professional operation and have certain limitations in their scope of use. The use and related research of traditional Chinese medicine aromatherapy are relatively few.

[0007] Traditional aromatherapy has a long history. Ancient books often record the external use of aromatic medicines to make incense, sticks, pillow incense, and pendants to ward off evil and prevent infectious diseases. The custom of hanging mugwort and calamus during the Dragon Boat Festival to ward off plague and evil spirits has a history of more than 3,000 years. The Compendium of Materia Medica records that "burning incense powder...applying it to the palace gate, the fragrance can be smelled for a hundred miles. During a great plague in Guanzhong, the dead lay piled up, but upon smelling this fragrance, the plague stopped and the dead rose." Aromatic Chinese medicine, as an important weapon for disease prevention and treatment in ancient times, played an irreplaceable role with its volatile oils. Traditional Chinese medicine theory believes that volatile oils have aromatic and penetrating properties, which can quickly exert therapeutic effects. Drug studies have shown that volatile oils have small molecular weights, high lipid solubility, and can easily cross biological membranes in the body, resulting in high bioavailability and rapid absorption and efficacy, consistent with traditional Chinese medicine theory. Chinese medicinal volatile oils possess anti-inflammatory, anti-allergic, antimicrobial, antimutagenic, anticancer, anthelmintic, enzyme-inhibiting, central nervous system-related, and respiratory system-related effects. Among these, there is a medicinal pillow therapy, which involves processing medicinal herbs with aromatic, orifice-opening, and qi-regulating properties and stuffing them into a pillow. During sleep, the herbs act on the meridians and blood vessels of the head and neck, adjusting the body's physical and mental state, improving immunity, and thus achieving health and wellness benefits.

[0008] Chinese Patent CN103040101B relates to a sophora flower-scented snuff made from pure natural raw materials, and also to a method for preparing the snuff. The snuff is composed of the following natural raw materials in parts by weight: 100-500 parts green tea leaves, 0.05-0.35 parts musk, 50-150 parts magnolia flower buds, 10-90 parts atractylodes rhizome, 100-300 parts patchouli leaves, 0.1-0.4 parts borneol, 0.03-0.10 parts asarum, 0.01-0.09 parts rhinoceros horn, 5-15 parts schizonepeta, 25-125 parts tobacco leaves, 2-6 parts agarwood, 2-6 parts cloves, 5-25 parts angelica dahurica, 2-6 parts menthol, and 50-150 parts red wine. The snuff of this invention, after being smoked with sophora flowers, has a refreshing sophora flower fragrance. This snuff can refresh the mind, improve nasal ventilation, and aid in smoking cessation.

[0009] Chinese Literature: Liu Chengxin, Wang Ting, Wu Hui, et al. Analysis of the Prescription Patterns of Traditional Chinese Medicine for Smoking Cessation Based on the National Patent Database [J]. Journal of Shandong University of Traditional Chinese Medicine, 2022, 46 (03): 345-350+364. DOI:10.16294 / j.cnki.1007-659x.2022.03.012. This paper publishes the analysis of the medication patterns of traditional Chinese medicine prescriptions for smoking cessation based on the national patent database. Methods: Traditional Chinese medicine prescriptions for smoking cessation based on the national patent database were collected and organized, including internal and external prescriptions. The prescriptions were entered into Microsoft Excel and the Traditional Chinese Medicine Inheritance Assistance Platform (V2.5). The drug frequencies were counted, and the drug association combinations and drug association rules were statistically analyzed. New prescription combinations were extracted.

[0010] There are currently no reports on safe, convenient, and effective traditional Chinese medicine methods for quitting smoking. Summary of the Invention

[0011] The first objective of this invention is to provide a traditional Chinese medicine composition with smoking cessation effects, addressing the shortcomings of the prior art.

[0012] The second objective of this invention is to provide the use of a traditional Chinese medicine composition with smoking cessation effects.

[0013] To achieve the first objective mentioned above, the technical solution adopted by the present invention is as follows:

[0014] A traditional Chinese medicine formula for smoking cessation, wherein the traditional Chinese medicine composition is made from the following raw materials in the indicated weight proportions: 20-60 parts of patchouli, 2-18 parts of cinnamon, 2-18 parts of fennel, 2-18 parts of agarwood, 2-18 parts of peppermint, 2-18 parts of clove, 2-18 parts of magnolia flower, 2-18 parts of atractylodes, 2-18 parts of borneol, 2-18 parts of houttuynia cordata, 2-18 parts of bitter orange flower, and 2-18 parts of styrax.

[0015] As a preferred example, the traditional Chinese medicine composition is made from the following raw materials in the indicated weight proportions: 30-50 parts of patchouli, 6-14 parts of cinnamon, 6-14 parts of fennel, 6-14 parts of agarwood, 6-14 parts of peppermint, 6-14 parts of clove, 6-14 parts of magnolia flower, 6-14 parts of atractylodes, 6-14 parts of borneol, 6-14 parts of houttuynia cordata, 6-14 parts of bitter orange flower, and 6-14 parts of styrax.

[0016] More preferably, the traditional Chinese medicine composition is made from the following raw materials in the indicated weight proportions: 40 parts of patchouli, 10 parts of cinnamon, 10 parts of fennel, 10 parts of agarwood, 10 parts of peppermint, 10 parts of clove, 10 parts of magnolia flower, 10 parts of atractylodes, 10 parts of borneol, 10 parts of houttuynia cordata, 10 parts of bitter orange flower, and 10 parts of styrax.

[0017] As another preferred example, the external use specifically involves making the traditional Chinese medicine composition into a traditional Chinese medicine pillow or a traditional Chinese medicine sachet.

[0018] To achieve the second objective mentioned above, the technical solution adopted by the present invention is as follows:

[0019] Application of any of the above-described traditional Chinese medicine compositions in the preparation of smoking cessation drugs.

[0020] The use of any of the above-described traditional Chinese medicine compositions in the preparation of drugs to alleviate respiratory symptoms.

[0021] the term

[0022] As used herein, the term "parts by weight" can be any fixed weight expressed in milligrams, grams, or kilograms (e.g., 1 mg, 1 g, 2 g, 5 g, or 1 kg). For example, a composition consisting of 1 part by weight of component a and 9 parts by weight of component b can be a composition consisting of 1 gram of component a + 9 grams of component b, or 10 grams of component a + 90 grams of component b, etc. In the composition, the percentage content of a component = (the number of parts by weight of that component / the sum of the number of parts by weight of all components) × 100%. Therefore, in a composition consisting of 1 part by weight of component a and 9 parts by weight of component b, the content of component a is 10%, and the content of component b is 90%.

[0023] Explanation: This application adheres to the treatment principle of "clearing the lungs and moistening dryness, aromatically resolving turbidity, and soothing the liver and regulating qi." The formula uses agastache rugosa, with its mellow aroma, as the principal herb to guide the other herbs and enhance their efficacy. Agastache rugosa is also effective in aromatically resolving dampness, which aligns well with the pathogenesis. Peppermint, magnolia flower, and atractylodes are used as assistant herbs to enhance the penetrating effect of agastache rugosa, while also clearing the head and eyes, and relieving heat and soothing the throat. The combination of agastache rugosa and peppermint creates a clear and aromatic effect, and can also replace the smell of tobacco, thus alleviating the psychological dependence of patients on tobacco. Cinnamon, which warms the middle and regulates qi, is also used as an assistant herb, both to assist agastache rugosa in resolving dampness and harmonizing the stomach, and to calm the mind and relieve withdrawal symptoms. Fennel, agarwood, cloves, and houttuynia cordata are used as adjuvant herbs. Fennel strengthens the stomach, regulates qi, and has antibacterial properties, working synergistically with the principal and assistant herbs. The combination of dampness-resolving herbs helps to resolve the stagnation of phlegm and blood stasis. The strong aroma of cloves, bitter orange blossoms, and styrax enhances the fragrance of patchouli and mint, replacing the smell of tobacco to alleviate the patient's psychological dependence on tobacco. It also has the effect of warming the middle and relieving nausea, making it an aromatic stomachic. Agarwood is used to lower qi and expel phlegm, and it is also good at regulating qi and harmonizing the middle. In addition, modern medicine has shown that agarwood has sedative, hypnotic, and antidepressant effects. Houttuynia cordata is slightly cold and has the effect of clearing heat and detoxifying. Because it enters the lung meridian, it is good at clearing lung heat and can treat symptoms such as cough with phlegm due to lung heat, thick yellow phlegm, and coughing up pus and blood caused by lung lobes. The pungent, warm, and aromatic borneol is used as a guide to help the other herbs penetrate the skin and achieve the effects of aromatically resolving turbidity, removing blood stasis and phlegm, and refreshing the mind and eliminating addiction.

[0024] The advantages of this invention are:

[0025] 1. The herbal composition of this invention is formulated by carefully selecting drugs under the guidance of traditional Chinese medicine theory and clinical experience. The drug components are combined according to the syndrome differentiation and complement each other in terms of their effects. The combination of each drug conforms to the principle of "principal, assistant, adjuvant and guide" in the treatment of nicotine addiction. Together, they achieve the effects of soothing the liver and regulating qi, nourishing essence and blood, promoting qi circulation and relieving depression, and clearing the mind and relieving irritability. This achieves both symptomatic and root-cause treatment for nicotine addiction.

[0026] 2. The components of the composition of the present invention are all natural Chinese herbal raw materials, which are easy to prepare, have a wide range of medicinal sources, and are low in cost; they follow the prescription and medication principles of traditional Chinese medicine; and clinical application has verified that its efficacy is significant and reliable, its medicinal properties are mild, and no toxic side effects have occurred.

[0027] 3. This invention has low usage costs, is used daily before bedtime, and has high compliance; it can be widely promoted and used in rural areas and other places with poor economic conditions, making it highly practical and with good application prospects. Detailed Implementation

[0028] The present invention will be further described below with reference to specific embodiments. It should be understood that these embodiments are for illustrative purposes only and are not intended to limit the scope of the invention. Furthermore, it should be understood that after reading the description of this invention, those skilled in the art can make various alterations or modifications to the invention, and these equivalent forms also fall within the scope defined by the appended claims.

[0029] Example 1: Preparation of the Traditional Chinese Medicine Composition for Smoking Cessation and Toxicity Reduction of the Present Invention (Part 1)

[0030] 40 parts of patchouli, 10 parts of cinnamon, 10 parts of fennel, 10 parts of agarwood, 10 parts of peppermint, 10 parts of clove, 10 parts of magnolia flower, 10 parts of atractylodes, 10 parts of borneol, 10 parts of houttuynia cordata, 10 parts of bitter orange flower, and 10 parts of styrax.

[0031] Example 2: Preparation of the Traditional Chinese Medicine Composition for Smoking Cessation and Toxicity Reduction of the Present Invention (Part Two)

[0032] 40 parts of patchouli, 6 parts of cinnamon, 14 parts of fennel, 2 parts of agarwood, 18 parts of peppermint, 10 parts of clove, 6 parts of magnolia flower, 14 parts of atractylodes, 2 parts of borneol, 18 parts of houttuynia cordata, 10 parts of bitter orange flower, and 6 parts of styrax.

[0033] Example 3: Preparation of the Traditional Chinese Medicine Composition for Smoking Cessation and Toxicity Reduction of the Present Invention (Part Three)

[0034] 30 parts of patchouli, 12 parts of cinnamon, 2 parts of fennel, 18 parts of agarwood, 10 parts of peppermint, 6 parts of clove, 14 parts of magnolia flower, 2 parts of atractylodes, 18 parts of borneol, 10 parts of houttuynia cordata, 16 parts of bitter orange flower, and 14 parts of styrax.

[0035] Example 4: Preparation of the Traditional Chinese Medicine Composition for Smoking Cessation and Toxicity Reduction of the Present Invention (Part Four)

[0036] 50 parts of patchouli, 2 parts of cinnamon, 18 parts of fennel, 10 parts of agarwood, 6 parts of peppermint, 14 parts of clove, 2 parts of magnolia flower, 18 parts of atractylodes, 10 parts of borneol, 6 parts of houttuynia cordata, 14 parts of bitter orange flower, and 2 parts of styrax.

[0037] Example 5: Preparation of the Traditional Chinese Medicine Composition for Smoking Cessation and Toxicity Reduction of the Present Invention (Part 5)

[0038] 20 parts of patchouli, 18 parts of cinnamon, 10 parts of fennel, 6 parts of agarwood, 14 parts of peppermint, 2 parts of clove, 18 parts of magnolia flower, 10 parts of atractylodes, 6 parts of borneol, 14 parts of houttuynia cordata, 2 parts of bitter orange flower, and 18 parts of styrax.

[0039] Example 6: Preparation of the Traditional Chinese Medicine Composition for Smoking Cessation and Toxicity Reduction of the Present Invention (VI)

[0040] 60 parts of patchouli, 10 parts of cinnamon, 6 parts of fennel, 14 parts of agarwood, 2 parts of peppermint, 18 parts of clove, 10 parts of magnolia flower, 6 parts of atractylodes, 14 parts of borneol, 2 parts of houttuynia cordata, 18 parts of bitter orange flower, and 10 parts of styrax.

[0041] Example 7 Preparation of the Traditional Chinese Medicine Composition for Smoking Cessation and Toxicity Reduction of the Present Invention (VII)

[0042] 40 parts of patchouli, 14 parts of cinnamon, 2 parts of fennel, 18 parts of agarwood, 10 parts of peppermint, 6 parts of clove, 14 parts of magnolia flower, 2 parts of atractylodes, 18 parts of borneol, 10 parts of houttuynia cordata, 6 parts of bitter orange flower, and 14 parts of styrax.

[0043] Example 8 Preparation of the Traditional Chinese Medicine Composition for Smoking Cessation and Toxicity Reduction of the Present Invention (VIII)

[0044] 30 parts of patchouli, 2 parts of cinnamon, 18 parts of fennel, 10 parts of agarwood, 6 parts of peppermint, 14 parts of clove, 2 parts of magnolia flower, 18 parts of atractylodes, 10 parts of borneol, 6 parts of houttuynia cordata, 14 parts of bitter orange flower, and 2 parts of styrax.

[0045] Example 9: Preparation of the Traditional Chinese Medicine Composition for Smoking Cessation and Toxicity Reduction of the Present Invention (IX)

[0046] 50 parts of patchouli, 18 parts of cinnamon, 10 parts of fennel, 6 parts of agarwood, 14 parts of peppermint, 2 parts of clove, 18 parts of magnolia flower, 10 parts of atractylodes, 6 parts of borneol, 14 parts of houttuynia cordata, 2 parts of bitter orange flower, and 18 parts of styrax.

[0047] Example 10 Preparation of the Traditional Chinese Medicine Composition for Smoking Cessation and Toxicity Reduction of the Present Invention (X)

[0048] 20 parts of patchouli, 10 parts of cinnamon, 6 parts of fennel, 14 parts of agarwood, 2 parts of peppermint, 18 parts of clove, 10 parts of magnolia flower, 6 parts of atractylodes, 14 parts of borneol, 2 parts of houttuynia cordata, 18 parts of bitter orange flower, and 10 parts of styrax.

[0049] Example 11 Preparation of the Traditional Chinese Medicine Composition for Smoking Cessation and Toxicity Reduction of the Present Invention (XI)

[0050] 60 parts of patchouli, 6 parts of cinnamon, 14 parts of fennel, 2 parts of agarwood, 10 parts of peppermint, 6 parts of clove, 14 parts of magnolia flower, 2 parts of atractylodes, 18 parts of borneol, 10 parts of houttuynia cordata, 6 parts of bitter orange flower, and 10 parts of styrax.

[0051] Example 12 Preparation of a medicinal pillow / sachet of a traditional Chinese medicine composition for smoking cessation and detoxification according to the present invention

[0052] Mix and crush any of the traditional Chinese medicine compositions in Examples 1 to 11 to obtain powder with a size of 200-400 mesh. Place the mixed powder in a breathable pure cotton fabric.

[0053] Example 13 Clinical Trial

[0054] 1. Research Subjects

[0055] 1.1 Source of cases

[0056] All cases were from volunteers recruited in the community, and a total of 100 patients were included.

[0057] 2 Diagnostic criteria

[0058] According to the 2015 edition of the Chinese Clinical Smoking Cessation Guidelines, the clinical diagnostic criteria for tobacco dependence are: if you have experienced or exhibited at least 3 of the following 6 criteria in the past year, a diagnosis can be made.

[0059] (1) Strong craving for smoking.

[0060] (2) Difficulty in controlling smoking behavior.

[0061] (3) Withdrawal symptoms occur when smoking is stopped or the amount of smoking is reduced.

[0062] (4) The tobacco tolerance manifests, meaning that an increase in the amount of smoking is required to obtain the smoking sensation that was previously obtained with a smaller amount of smoking.

[0063] (5) Giving up or reducing other activities and hobbies because of smoking.

[0064] (6) Persisting in smoking despite the harm of smoking.

[0065] 2.3 Inclusion Criteria

[0066] I. Meets the clinical diagnostic criteria for tobacco dependence;

[0067] II. Age 18-65 years old;

[0068] 3. Smoking history ≥ 2 years;

[0069] IV. Tobacco-dependent patients who receive TCM diagnosis and treatment at their first visit (baseline).

[0070] 5. Those who agree and sign the informed consent form.

[0071] 2.4 Exclusion Criteria

[0072] I. Excluding patients with serious primary diseases of the heart, brain, lungs, liver, kidneys and hematopoietic system, as well as patients with mental illness;

[0073] II. Patients whose medical records contain severely incomplete information regarding the four diagnostic methods of Traditional Chinese Medicine;

[0074] Third, use drugs that act on the central nervous system, especially antidepressants or anxiolytics.

[0075] 2.5 Elimination Criteria

[0076] Cases already enrolled but meeting one of the following criteria will be excluded:

[0077] I. Misdiagnosis and mistreatment;

[0078] II. Those whose lack of treatment records or incomplete data affects the judgment of treatment efficacy;

[0079] 3. Those who receive additional treatment medications during the treatment period.

[0080] 2.6 Shedding Criteria

[0081] Enrolled cases that did not complete treatment for the following reasons were considered dropouts:

[0082] (1) Patients who withdraw voluntarily;

[0083] (2) Loss to follow-up;

[0084] (3) Poor compliance, other conditions affecting treatment, serious adverse events, etc.;

[0085] 3. Research Methods

[0086] 3.1 Grouping Method

[0087] A completely randomized grouping method was used, and a random number table was used to divide the enrolled patients into a treatment group and a control group.

[0088] 3.2 Treatment methods

[0089] I. Control Group: A mixture of 40 parts agastache, 10 parts cinnamon, 10 parts fennel, 10 parts agarwood, 10 parts peppermint, 10 parts clove, 10 parts magnolia flower, 10 parts atractylodes, 10 parts borneol, 10 parts houttuynia cordata, 10 parts bitter orange blossom, and 10 parts styrax were blended with ginger juice and rice wine and prepared into a plaster using modern technology. The acupoints selected were the smoking cessation point, Fenglong point, Tanzhong point, and Tiantu point. Each acupoint was treated twice a week for two days each time.

[0090] II. Treatment Group: Herbal Sachets. The herbal ingredients in the sachets are: 40 parts of patchouli, 10 parts of cinnamon, 10 parts of fennel, 10 parts of agarwood, 10 parts of peppermint, 10 parts of clove, 10 parts of magnolia flower, 10 parts of atractylodes, 10 parts of borneol, 10 parts of houttuynia cordata, 10 parts of bitter orange flower, and 10 parts of styrax. The sachets are filled with these ingredients and worn on the chest during the day. If cravings occur, the sachet can be opened and the inhalation can be done for 1 minute. At night, the sachet can be opened and placed next to the pillow before going to sleep.

[0091] III. Observe the therapeutic effect after 3 months of intervention.

[0092] 3.3 Observation Indicators

[0093] Criteria for judging therapeutic efficacy:

[0094] Cure: The desire to smoke disappears, and there is no urge to smoke at any time or in any environment; no withdrawal syndrome occurs; the addiction to smoking is completely eliminated, an aversion to tobacco is developed, and there is no longer dependence on nicotine.

[0095] Significant effect: Although there is no desire to smoke, relapse is easy due to changes in the smoking environment and external inducing factors.

[0096] Effective: The desire to smoke is significantly reduced, there is an unpleasant taste in the mouth when smoking, and withdrawal symptoms are significantly reduced compared to quitting smoking by willpower (cold turkey); the effect can be maintained for a period of time, but eventually relapse occurs.

[0097] Ineffective: The understanding of smoking cessation is still at a crossroads, the psychological approach to smoking cessation is immature, the patient does not fully cooperate with medical intervention, stops smoking cessation on their own, interrupts treatment and starts smoking again.

[0098] 3.4 Treatment Efficacy

[0099] 3.4.1 Statistical Methods

[0100] Data were analyzed using SPSS 15.0 statistical software. Ordinal data were analyzed using Ridit analysis and Fisher's exact test. For continuous data, paired t-tests were used to compare pre- and post-treatment data within groups, and F-tests were used to compare data between groups.

[0101] 3.4.2 Research Results

[0102] The efficacy of the two smoking cessation treatments was compared. The overall success rate of quitting smoking in the treatment group was 90.00%, while that in the control group was 66.00%. The difference between the two groups was statistically significant. The results are shown in Table 1. The experimental results indicate that the efficacy of the treatment group was significantly better than that of the control group. This suggests that the traditional Chinese medicine composition has the advantage of good efficacy within a certain weight ratio. The significantly better efficacy of the treatment group compared to the control group indicates that the various medicinal ingredients in the composition of this invention have a synergistic effect and good efficacy.

[0103]

[0104] Example 15 Animal Experiment

[0105] 1. Experimental Materials

[0106] 1.1 Animals

[0107] Seventy male SD rats (180-220g), aged 6-8 weeks, were housed in a clean-grade animal room with alternating 12h light / 12h dark cycles, a temperature of 22-25℃, and a humidity of 40%-70%. The rats were acclimatized to the environment for approximately one week prior to the experiment, with free access to food and water.

[0108] 1.2.1 Modeling Drugs

[0109] Nicotine: analytical grade, pale yellow oily liquid. Nicotine was dissolved in physiological saline to prepare a nicotine solution before modeling.

[0110] 1.2.2 Main Drugs

[0111] The first component of this invention is a traditional Chinese medicine composition: 40 parts of agastache, 10 parts of cinnamon, 10 parts of fennel, 10 parts of agarwood, 10 parts of peppermint, 10 parts of clove, 10 parts of magnolia flower, 10 parts of atractylodes, 10 parts of borneol, 10 parts of houttuynia cordata, 10 parts of bitter orange flower, and 10 parts of styrax are weighed according to the following weight ratios and made into a sachet. The sachet is placed on top of a transparent plexiglass container and inhaled daily for 12 weeks.

[0112] The second component of this invention is a traditional Chinese medicine composition: 40 parts of agastache, 14 parts of cinnamon, 2 parts of fennel, 18 parts of agarwood, 10 parts of peppermint, 6 parts of clove, 14 parts of magnolia flower, 2 parts of atractylodes, 18 parts of borneol, 10 parts of houttuynia cordata, 6 parts of bitter orange flower, and 14 parts of styrax are weighed according to the following proportions and made into a sachet. The sachet is placed on top of a transparent plexiglass container and inhaled daily for 12 weeks.

[0113] Control group 1: The following traditional Chinese medicine composition was prepared by weighing 100-300 parts of patchouli leaves, 50-150 parts of magnolia flower, 10-90 parts of atractylodes rhizome, 0.1-0.4 parts of borneol, 2-6 parts of agarwood, 2-6 parts of clove, and 2-6 parts of menthol according to the weight ratio. The sachet was placed on top of a transparent plexiglass container and inhaled daily for 12 weeks.

[0114] Control group 2: The following traditional Chinese medicine composition was prepared by weighing 40 parts of agastache, 14 parts of magnolia flower, 2 parts of atractylodes, 18 parts of borneol, 18 parts of agarwood, 6 parts of clove, 10 parts of peppermint, 14 parts of cinnamon, and 2 parts of fennel to make a sachet. The sachet was placed on top of a transparent plexiglass container and inhaled daily for 12 weeks.

[0115] 1.3 Main Instruments

[0116] Small benchtop centrifuge, -80℃ low-temperature freezer, electronic analytical balance, ELISA kit (TNF-α, IL-6, IL-1β), 20×20×20cm transparent acrylic container.

[0117] 1.4 Modeling Method

[0118] Ten rats were divided into a blank group and injected with physiological saline daily. The remaining rats were used to establish a model. The rats were injected subcutaneously with nicotine at a dose of 0.4 mg / kg and 1 mg / ml twice a day for 7 consecutive days. On the 8th day, the successfully modeled rats were randomly divided into groups of 10 each. One group was used as the model group and was not given any drug. The other four groups were given the drug in the same manner as above.

[0119] 1.5 Physical signs and behavioral observations

[0120] Chewing / malocclusion; writhing / breathing; trembling / shuddering; and other symptoms (licking feet, scratching, and yawning) are scored as 1 point by dividing the frequency of occurrence by 10; ptosis is scored as 1, 2, and 3 points for mild, moderate, and severe, respectively. 1.6

[0122] Detection Indicators and Methods: 24 hours after the last administration, rats in each group were anesthetized by intraperitoneal injection of 2% sodium pentobarbital (30 mg / kg). After anesthesia, the rats underwent tracheotomy, a hollow catheter was inserted, the right bronchus was ligated, and the left lung was lavaged with 5 ml of cold physiological saline into the left bronchus. This was repeated three times, with a recovery rate greater than 90%. The collected BALF (bronchial bronchoalveolar lavage fluid) was centrifuged at 3000 r / min for 10 min at 4℃, and the supernatant was collected in EP tubes and stored at -80℃. The levels of TNF-α, IL-6, and IL-1β in the lavage fluid were detected by enzyme-linked immunosorbent assay (ELISA).

[0123] 2. Statistical Analysis

[0124] SPSS 16.0 statistical software was used for analysis and processing. Data are expressed as (x±s), and t-tests were used for comparisons between groups.

[0125] 3 Results

[0126] 3.1 Physical signs and behavioral results

[0127] As shown in Table 2, it can be seen that the frequency of chewing / malocclusion, writhing / panting, tremors / shuddering and other symptoms in rats after modeling was significantly increased. The data of the treatment group were significantly different from those of the model group, indicating that they could all achieve the effect of reducing nicotine withdrawal symptoms. Compared with control group 1, the other treatment groups were significantly different from control group 1.

[0128]

[0129] 3.2 TNF-α, IL-6, IL-1β content

[0130] Referring to Table 3, compared with the blank group, the levels of airway inflammatory factors TNF-α, IL-6, and IL-1β in the model group rats were significantly increased, showing a statistically significant difference; while compared with the model group, the levels of airway inflammatory factors in the other treatment groups were significantly decreased, showing a statistically significant difference; compared with control group 1, the levels of airway inflammatory factors in the other treatment groups showed a statistically significant difference.

[0131]

[0132] Note: * indicates P < 0.05 compared to the model group; # indicates P < 0.05 compared to the control group in other treatment groups.

[0133] Furthermore, the control group showed improvement in symptoms before and after treatment compared to the model group, demonstrating a definite therapeutic effect. The above description is merely a preferred embodiment of the present invention. It should be noted that those skilled in the art can make several improvements and additions without departing from the method of the present invention, and these improvements and additions should also be considered within the scope of protection of the present invention.

Claims

1. A topical Chinese medicine composition for smoking cessation, characterized in that, The traditional Chinese medicine composition is made of the following raw medicinal materials in parts by weight: agastache 20-60 parts, cassia 2-18 parts, fennel 2-18 parts, eaglewood 2-18 parts, mint 2-18 parts, clove 2-18 parts, lily of the valley 2-18 parts, Chinese artichoke 2-18 parts, borneol 2-18 parts, fishy-smelling grass 2-18 parts, daisy 2-18 parts, styrax 2-18 parts.

2. The external use traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is made of the following raw medicinal materials in parts by weight: agastache 30-50 parts, cassia 6-14 parts, fennel 6-14 parts, eaglewood 6-14 parts, mint 6-14 parts, clove 6-14 parts, lily of the valley 6-14 parts, Chinese artichoke 6-14 parts, borneol 6-14 parts, fishy-smelling grass 6-14 parts, daisy 6-14 parts, styrax 6-14 parts.

3. The external use traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is made of the following raw medicinal materials in parts by weight: agastache 40 parts, cassia 10 parts, fennel 10 parts, eaglewood 10 parts, mint 10 parts, clove 10 parts, lily of the valley 10 parts, Chinese artichoke 10 parts, borneol 10 parts, fishy-smelling grass 10 parts, daisy 10 parts, styrax 10 parts.

4. Use of the external traditional Chinese medicine composition according to any one of claims 1-3 in the preparation of a medicine for smoking cessation.

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