Traditional Chinese medicine composition for treating liver depression and qi stagnation type globus hysteriocus and preparation method thereof

Abstract

The invention relates to the field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating liver depression and qi stagnation type globus hysteriocus and a preparation method of the traditional Chinese medicine composition. More specifically, the invention provides a traditional Chinese medicine composition which comprises pinellia ternate, mangnolia officinalis, poria cocos, caulis perllae, radix asteris, fingered citron and rose. Preferably, the pinellia ternate is rhizoma pinelliae preparata. By applying the traditional Chinese medicine composition, the liver depression and qi stagnation type globus hysteriocus can be effectively treated, and the recurrence rate of the liver depression and qi stagnation type globus hysteriocus can be reduced.

Description

Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine, and in particular to a traditional Chinese medicine composition for treating liver depression and qi stagnation type plum pit qi and a preparation method thereof. Background Art

[0002] Plum pit qi (gum pit qi) is a common condition in Traditional Chinese Medicine (TCM). It's characterized by a foreign body sensation in the throat, like a plum pit, that can't be coughed up or swallowed. While this condition doesn't affect normal eating or breathing, it can cause significant throat discomfort and psychological distress. It's most common in young and middle-aged adults, particularly women.

[0003] 1. Etiology and pathogenesis

[0004] According to Traditional Chinese Medicine, the occurrence of plum pit qi is often related to emotional distress. When emotional distress occurs, liver qi stagnates, invading the spleen and stomach, leading to dysfunctional spleen function and impaired fluid distribution. This condenses into phlegm, which then blocks the throat and causes the disease. Furthermore, liver depression transforming into fire and lung and kidney yin deficiency can also lead to a lack of nourishment for the throat, resulting in symptoms similar to plum pit qi. For example, the "Golden Chamber Synopsis: Miscellaneous Diseases in Women: Pulse and Symptoms and Treatments" describes the symptoms and classic treatment of plum pit qi: "If a woman feels as if there is roasted meat in the throat, Banxia Houpu Decoction is the main treatment," emphasizing the importance of the interaction of phlegm and qi in the pathogenesis of the disease. Depending on the syndrome, plum pit qi can be divided into phlegm and qi interaction, liver depression and qi stagnation, heart and spleen deficiency, and lung and stomach yin deficiency.

[0005] 2. Clinical Manifestations and Diagnosis

[0006] Patients often experience a foreign body sensation, obstruction, burning, or ants crawling in the throat. Symptoms fluctuate, often worsening with emotional distress or concentration, and lessening with eating or swallowing saliva. Pharyngeal examination typically reveals no obvious abnormalities or only mild pharyngeal mucosal congestion and lymphoid follicle hyperplasia. Diagnosis of globus pharyngeus requires exclusion of organic lesions of the throat and adjacent organs, such as pharyngitis, laryngitis, laryngeal tumors, esophagitis, and thyroid disease. Laryngoscopy, gastroscopy, and neck ultrasound can be used to confirm the diagnosis.

[0007] 3. Treatment Methods

[0008] For patients with globus pharyngitis who present with significant psychological factors such as anxiety and depression, Western medicine can provide antianxiety and antidepressant medications, such as selective serotonin reuptake inhibitors (SSRIs). Local throat medications, such as lozenges and sprays, can also be used to alleviate pharyngeal discomfort. However, Western medicine treatments often focus on symptomatic treatment and are relatively limited in their overall effectiveness in regulating globus pharyngitis.

[0009] Currently, treatments for globus hysterica typically focus on symptomatic treatment, providing short-term relief of symptoms but prone to recurrence under predisposing factors. Long-term use of medications such as antianxiety and depression medications can be difficult to discontinue or worsen, leading to patient resistance and reduced compliance. Furthermore, due to cultural factors and a shortage of specialists, psychotherapy (cognitive behavioral therapy) is often of low quality and poorly standardized in primary and general hospitals in my country, or even absent.

[0010] Plum-pit qi, a condition characterized by a foreign body sensation in the pharynx, has extensive theoretical and practical experience in its etiology, pathogenesis, and treatment methods. Traditional Chinese medicine (TCM) has gained widespread acceptance and recognition due to its unique advantages, proven efficacy, minimal adverse reactions, and lack of drug resistance. TCM considers the pharynx to be the gateway to the throat, a crucial barrier for pathogenic factors to enter the body. When the throat is diseased, the tonsils are the primary target. The pharynx and larynx are located in a small area just above and just inside the cervical spine. The pharynx serves as a passage for food and drink, while the larynx serves as a passage for breath, each fulfilling its own function and working in tandem. While throat diseases can have many causes, they are generally attributed to qi stagnation and phlegm congestion. These stagnations, combined with qi stagnation and phlegm congestion, can lead to a variety of throat symptoms. TCM's holistic approach and comprehensive treatment, combined with symptomatic treatment in Western medicine, can effectively alleviate symptoms and improve quality of life. Furthermore, a focus on prevention and treatment is crucial for reducing the incidence and recurrence of plum-pit qi.

[0011] However, existing prescriptions, such as Banxia Houpu Decoction, primarily target localized throat discomfort while neglecting to alleviate the patient's emotions. For patients with liver depression and qi stagnation-type globus pharyngeus, while localized throat discomfort can be alleviated with existing Banxia Houpu Decoction, subsequent recurrence is highly likely due to emotional stimulation. Therefore, there is an urgent need for a traditional Chinese medicine composition that can more specifically treat liver depression and qi stagnation-type globus pharyngeus and reduce its recurrence rate. Summary of the Invention

[0012] In view of this, the purpose of the present invention is to provide a traditional Chinese medicine composition for treating liver depression and qi stagnation type plum pit qi, which has the main effects of soothing the liver and relieving depression, promoting qi and eliminating fullness, and can be used for plum pit qi caused by liver depression and qi stagnation and liver qi disharmony.

[0013] In the first aspect, the present invention provides a traditional Chinese medicine composition for treating liver depression and qi stagnation type plum pit qi, which includes: pinellia, magnolia bark, poria, sophora flavescens, aster, citron, and rose; preferably, the pinellia is qing pinellia.

[0014] In a second aspect, the present invention provides a traditional Chinese medicine preparation, which is prepared from the traditional Chinese medicine composition of the first aspect of the present invention.

[0015] In a third aspect, the present invention provides use of the Chinese medicine composition of the first aspect of the present invention or the Chinese medicine preparation of the second aspect of the present invention in preparing a medicament for treating liver depression and qi stagnation type plum pit qi.

[0016] The Chinese medicine composition or Chinese medicine preparation of the present invention can effectively treat liver depression and qi stagnation type plum pit qi. At the same time, since the present invention introduces liver-soothing, depression-relieving and spleen-invigorating drugs in the prescription design, it can effectively relieve the patient's emotions and greatly reduce the recurrence of liver depression and qi stagnation type plum pit qi. DETAILED DESCRIPTION

[0017] The present invention will be described clearly and completely below in conjunction with the embodiments of the present invention. Obviously, the embodiments described are only a portion of the embodiments of the present invention, rather than all of the embodiments. All other embodiments that can be obtained by those of ordinary skill in the art based on the embodiments of the present invention fall within the scope of protection of the present invention.

[0018] In this article, all parts are by weight, and weight is calculated based on the weight of the crude drug or API. The parts by weight can be weight units known in the pharmaceutical field such as microgram (μg), milligram (mg), gram (g), kilogram (kg), etc., or can be fractions thereof, such as 1 / 10, 1 / 100, or multiples thereof, such as 10 times, 100 times, etc., but are not limited thereto.

[0019] Plum pit qi is a disease caused by emotional fluctuations and sluggish qi movement, and is characterized by a feeling of obstruction in the throat like a plum pit. The main symptom of this disease is a feeling of obstruction in the throat like a plum pit, roasted meat, or other foreign body, and it occurs with emotional fluctuations. It is generally seen in adults, more common in women. Examination of the throat, esophagus and other related organs shows no organic lesions.

[0020] According to different symptoms, plum pit qi can be divided into phlegm and qi syndrome, liver depression and qi stagnation syndrome, heart and spleen deficiency syndrome and lung and stomach yin deficiency syndrome:

[0021] 1. Phlegm and Qi syndrome: foreign body sensation in the throat, inability to swallow or spit out, occasional belching, hiccups, nausea, urge to vomit, and chest and abdominal distension. White and greasy tongue coating, slippery and wiry pulse;

[0022] 2. Liver depression and qi stagnation syndrome: A feeling of obstruction in the pharynx, frequent belching, or hiccups, fullness and tightness under the ribs, which is slightly relieved after belching. The tongue coating is thin and white, and the pulse is stringy.

[0023] 3. Heart and spleen deficiency syndrome: foreign body sensation in the throat, loss of appetite, loss of taste in the mouth, pale complexion, fatigue, shortness of breath and laziness, or frequent sadness and crying, restless sleep, easy awakening or anxiety, clear and long urine, loose and thin stools. Pale tongue with white fur, weak pulse;

[0024] 4. Lung and stomach yin deficiency syndrome: dry and itchy throat, thirsty with a preference for cold drinks, a feeling of blockage in the throat, hot palms and soles, flushed face, dizziness, tinnitus, bitter taste in the mouth, and yellow urine. A red tongue with or little coating, and a weak or thready pulse.

[0025] In the present invention, the main focus is on liver depression and qi stagnation type plum pit qi, and the purpose is to provide a traditional Chinese medicine composition for treating liver depression and qi stagnation type plum pit qi, whose main effects are to soothe the liver and relieve depression, promote qi and eliminate abdominal distension.

[0026] In a first aspect, the present invention provides a traditional Chinese medicine composition for treating liver depression and qi stagnation type plum pit qi, comprising: pinellia, magnolia bark, poria, perilla stem, aster, bergamot, and rose.

[0027] In one embodiment, the traditional Chinese medicine composition further comprises chicken gizzard lining, ginger, bletilla striata, panax notoginseng and mint.

[0028] In the traditional Chinese medicine system, the various Chinese herbs used in the traditional Chinese medicine composition of the present invention have the following effects:

[0029] Pinellia ternata, also known as three-leaf pinellia, three-step jump, hemp taro, water taro, and ground croton, is the medicinal part of the tuber of the Araceae plant Pinellia ternata; nature and flavor: warm, pungent, toxic, enters the spleen, stomach, and lung meridians; efficacy: drying dampness and resolving phlegm, relieving adverse symptoms and stopping vomiting, and eliminating lumps and dispersing nodules.

[0030] Pinellia ternata can be further divided into raw, processed, ginger, and clear. Raw Pinellia ternata is highly toxic and can cause severe irritation to the mouth and throat when used directly without processing, requiring caution when used. However, after processing, the clear, ginger, and processed Pinellia ternata have reduced toxicity and improved safety. Raw and clear Pinellia ternata are more effective in drying dampness and resolving phlegm. Raw Pinellia ternata is more effective at resolving phlegm and dispersing stagnation, and is more effective for treating stubborn and old phlegm. Clear Pinellia ternata, processed with alum, is better at drying dampness and resolving phlegm, and is often used to treat coughs caused by damp phlegm and excessive phlegm. Ginger Pinellia ternata, processed with ginger and alum, is particularly effective in relieving nausea and vomiting, and is commonly used to treat various vomiting conditions, especially vomiting caused by stomach cold. By soothing the stomach and reducing nausea, it effectively alleviates vomiting symptoms. Processed with licorice and lime, it is warming in nature and has a significant warming and resolving cold phlegm effect. It can warm yang and resolve phlegm for coughs caused by cold and damp phlegm, as well as for clearing and thinning phlegm. Therefore, in a preferred embodiment, the pinellia is qingbanxia.

[0031] Magnolia officinalis (Magnoliae Officinalis Cortex), also known as thick bark, heavy bark, red bark, oil bark, Sichuan bark, and purple oil bark, is the medicinal part of the stem bark, root bark, and branch bark of the Magnoliaceae plant Magnolia officinalis. Its nature and flavor are warm, bitter and pungent, and it enters the spleen, stomach, lung, and large intestine meridians. Its effects are: drying dampness and eliminating phlegm, and relieving gas and fullness.

[0032] Poria cocos (Schw) Wolf, the medicinal part is the dried sclerotia of the Polyporaceae fungus Poria cocos; its nature and flavor are sweet, light, and neutral, and it enters the heart, spleen, lung, and kidney meridians; its effects are: dispelling dampness and promoting diuresis, benefiting the spleen and stomach, and calming the mind and tranquilizing the nerves.

[0033] Perillae Caulis, also known as Perilla stem, Perilla stem, Perilla rod, Perilla stem, Perilla grass, Perilla branch stem, the medicinal part is the stem of Perilla frutescens of the Lamiaceae family; nature and flavor and meridians: warm in nature, pungent in taste, enters the spleen and lung meridians; effects: regulating qi, relieving fullness, relieving pain, and calming the fetus.

[0034] Aster (Asteris Radix et Rhizoma), also known as green vine, aster, resurrection grass root, night glory, aster antler, Guan Gong beard, the medicinal part is the root and rhizome of the Aster plant of the Asteraceae family; nature and flavor: warm, bitter and pungent, enters the lung meridian; efficacy: moistens the lungs and relieves qi, eliminates phlegm and relieves cough.

[0035] Buddha's hand (Citrisarcodactylis Fructus), also known as Guangdong Buddha's hand, Buddha's hand fruit, five-finger orange, bergamot, and milo orange, is the dried mature fruit of the Rutaceae plant Buddha's hand; nature and flavor: warm in nature, sour, bitter, and pungent in taste, enters the liver, spleen, stomach, and lung meridians; effects: soothes the liver and regulates qi, harmonizes the stomach and relieves pain.

[0036] Rose (Rosae Rugosae Flos), also known as red rose, wandering flower, pen head flower, lake flower, thorn rose flower, and processed rose chrysanthemum, is the medicinal part of the first blooming flower of the rose plant of the Rosaceae family; nature and flavor: warm in nature, sweet, slightly bitter, enters the liver and spleen meridians; effects: promotes qi and relieves depression, harmonizes blood and relieves pain.

[0037] Chicken gizzard lining (Galli Gigeriae Endothelium Corneum), also known as chicken yellow skin, chicken zygote, and chicken gold, is the medicinal part of the dried inner wall of the gizzard of the domestic chicken of the Phasianidae family. Its nature and flavor are neutral, and it enters the spleen, stomach, small intestine, and bladder meridians. Its effects are: invigorating the stomach and aiding digestion, astringing sperm to stop nocturnal emission, and dispelling urinary tract infections and dissolving stones.

[0038] Ginger (Zingiber Boehm), also known as ginger, is the fresh rhizome of the perennial herb Zingiber officinale of the Zingiberaceae family. Its nature and flavor are pungent and slightly warm, and it enters the lung, spleen, and stomach meridians. Its effects are: relieving exterior symptoms and dispersing cold, warming the middle and stopping vomiting, and resolving phlegm and relieving cough.

[0039] Bletilla striata, also known as Lianjicao, frostbite medicine, sweet root, and white chicken, is the tuber of the orchid plant Bletilla striata. Its nature and meridians are slightly cold, bitter, sweet, and astringent. It enters the lung, liver, and stomach meridians. Its effects are astringent, hemostatic, and tissue-stimulating.

[0040] Notoginseng Radix, also known as Panax notoginseng, ginseng notoginseng, Panlongqi, Jinbuhuan, blood ginseng, and mountain lacquer, is the root and rhizome of the Araliaceae plant Panax notoginseng; nature and flavor: warm in nature, sweet and slightly bitter in taste, enters the liver and stomach meridians; effects: promotes blood circulation, removes blood stasis, stops bleeding, reduces swelling and relieves pain.

[0041] Mint (NotoginsengRadix), also known as silver dan grass, water motherwort, swelling-removing herb, and fanhecai, is the medicinal part of the mint plant of the Lamiaceae family. Its nature and flavor are cool in nature, spicy in taste, and it enters the liver and lung meridians. Its effects are: dispersing wind-heat, clearing the throat, and promoting rash.

[0042] In the traditional Chinese medicine composition of the present invention, the main medicines are Pinellia ternata, Magnolia officinalis and Poria cocos, which are mainly used for promoting qi, drying dampness and resolving phlegm, and promoting qi and removing dampness and phlegm; the auxiliary medicines include two groups: one group is Sophora flavescens and Aster tataricus, which can assist the main medicine in promoting qi and resolving phlegm, and the other group is Citron and Rose, which can soothe the liver, relieve depression and invigorate the spleen; the adjuvant medicines also include two groups: one group is Chicken Gizzard Stone and Ginger, which can assist the auxiliary medicine in strengthening the spleen, digesting food and nourishing the stomach, and the other group is Bletilla striata and Panax notoginseng, which can support the old and bring about the new, and reduce swelling and promote tissue regeneration; the guiding medicine is Peppermint, which is a meridian-guiding medicine.

[0043] Those skilled in the art will understand that the adjuvants of the present invention are auxiliary drugs, i.e., they assist the principal and ministerial drugs to enhance the therapeutic effect; the guiding drugs can be 1) guiding drugs, which guide the other drugs in the prescription to the affected area; or 2) harmonizing drugs, which have the function of harmonizing the other drugs. In the present invention, the guiding drug is the guiding drug. The adjuvant or guiding drug can be replaced by other appropriate traditional Chinese medicines with the same medicinal properties, and it is expected that the traditional Chinese medicine composition after replacement will still have the same medicinal effect.

[0044] In one embodiment, the Chinese medicine composition of the present invention includes: 10-12 parts of Pinellia, 8-10 parts of Magnolia officinalis, 10-12 parts of Poria, 10-15 parts of Sophora flavescens, 15-20 parts of Aster, 10-15 parts of Citron, 10-12 parts of Rose, 15-20 parts of Chicken Gizzard Stone, 10-15 parts of Ginger, 10-12 parts of Bletilla striata, 3-4 parts of Panax notoginseng, and 5-6 parts of Menthol, wherein the parts of each Chinese medicine are by weight.

[0045] More specifically, in the traditional Chinese medicine composition, by weight, the pinellia tuber can be 10, 11, or 12 parts, the magnolia bark can be 8, 9, or 10 parts, the poria can be 10, 11, or 12 parts, the sophora flavescens can be 10, 11, 12, 13, 14, or 15 parts, the aster can be 15, 16, 17, 18, 19, or 20 parts, the bergamot can be 10, 11, 12, 13, 14, or 15 parts, the rose can be 10, 11, or 12 parts, the chicken's gizzard lining can be 15, 16, 17, 18, 19, or 20 parts, the ginger can be 10, 11, 12, 13, 14, or 15 parts, the bletilla striata can be 10, 11, or 12 parts, the panax notoginseng can be 3 or 4 parts, and the mint can be 5 or 6 parts.

[0046] In a specific embodiment, the Chinese medicine composition of the present invention includes: 10 parts of Pinellia, 10 parts of Magnolia officinalis, 10 parts of Poria, 15 parts of Sophora flavescens, 20 parts of Aster, 15 parts of Citron, 10 parts of Rose, 20 parts of Chicken Gizzard Stone, 15 parts of Ginger, 10 parts of Bletilla striata, 3 parts of Panax notoginseng, and 5 parts of Menthol.

[0047] In a second aspect, the present invention provides a traditional Chinese medicine preparation, which is prepared from the traditional Chinese medicine composition of the first aspect of the present invention.

[0048] In one embodiment, the traditional Chinese medicine preparation can be a decoction, a spray, a granule, a lozenge or a powder.

[0049] In a specific embodiment, the Chinese medicine preparation is a decoction, which is prepared by the following method:

[0050] 1) Weigh each Chinese herbal medicine in the Chinese herbal medicine composition of the present invention according to the prescribed weight ratio, add water to cover all the herbs and soak for 30-40 minutes;

[0051] 2) boiling the Chinese medicine composition over high heat and then simmering over low heat for 30-40 minutes, filtering out the first medicinal liquid;

[0052] 3) Add water to cover the remaining medicinal residue, boil over high heat, then simmer over low heat for 30-40 minutes, and filter out the second medicinal liquid;

[0053] 4) Combining the first medicinal liquid and the second medicinal liquid to form a decoction.

[0054] More specifically, when administered, the decoction is taken as one dose per day, divided into two doses. In this article, the decoction can also be referred to as the Qi-Exerting and Depression-Relieving Decoction.

[0055] As used herein, the terms "high heat" and "low heat" refer to the temperature requirements specified in the processing standards of Traditional Chinese Medicine (TCM). High heat is typically 150-180°C, while low heat is typically 80-120°C. High heat is intense and rapid, resulting in a rapid temperature rise and water evaporation. Using high heat for rapid decoction allows for the rapid extraction of active ingredients from medicinal materials. Low heat is less intense and gentle, with no or a small flame. Temperature rises more slowly, resulting in slower water evaporation. Low heat maintains a slight boil, facilitating the extraction of active ingredients.

[0056] In a specific embodiment, the traditional Chinese medicine preparation is a spray, which is prepared by the following method:

[0057] 1) decocting the various Chinese medicinal herbs in the Chinese medicinal composition into a decoction, and then concentrating and filtering the decoction to obtain a clear solution for the spray; or

[0058] 2) boiling and concentrating the various Chinese medicinal herbs in the Chinese medicinal composition into a clear paste, then dissolving the clear paste in a solvent such as sterile saline or sterile water, mixing well, and filtering to obtain a clear solution as the spray.

[0059] In a more specific embodiment, the decoction is prepared from a Chinese medicine composition comprising 10 parts of Pinellia ternata, 10 parts of Magnolia officinalis, 10 parts of Poria cocos, 15 parts of Sophora flavescens, 20 parts of Aster tataricus, 15 parts of Citron, 10 parts of Rose Flos, 20 parts of Gallus gallus domesticus, 15 parts of Ginger, 10 parts of Bletilla striata, 3 parts of Panax notoginseng, and 5 parts of Menthol. The decoction is then further decocted and concentrated to an appropriate concentration, and then filtered to remove impurities and insoluble matter to obtain a clear solution for use as a spray. Optionally, the spray preparation method further comprises dispensing the obtained clear solution into a sprayer.

[0060] In a more specific embodiment, a Chinese medicine composition comprising 10 parts of Pinellia ternata, 10 parts of Magnolia officinalis, 10 parts of Poria cocos, 15 parts of Sophora flavescens, 20 parts of Aster tataricus, 15 parts of Citron, 10 parts of Rosaceae, 20 parts of Chicken Gizzard Stone, 15 parts of Ginger, 10 parts of Bletilla striata, 3 parts of Panax notoginseng, and 5 parts of Menthol is prepared into the above-mentioned decoction, which is further decocted and concentrated into a paste with a relative density of about 1.20, and then dissolved in about 100 ml of sterile water. After mixing evenly, the mixture is filtered to remove impurities and insoluble matter, and the clear solution is obtained and dispensed into a sprayer.

[0061] More specifically, during administration, the spray is sprayed on the pharynx 4-6 times a day, with 1-2 ml sprayed each time. To ensure the therapeutic effect, it is not recommended to drink water within ten minutes after each spraying.

[0062] In a third aspect, the present invention provides use of the Chinese medicine composition of the first aspect of the present invention or the Chinese medicine preparation of the second aspect of the present invention in preparing a medicament for treating liver depression and qi stagnation type plum pit qi.

[0063] In one embodiment, the drug is used in combination with other Western medicines such as anti-anxiety and antidepressant drugs to treat liver depression and qi stagnation type plum pit qi.

[0064] Example

[0065] Example 1: Preparation of Chinese medicine preparation

[0066] 1. Preparation of Xingqi Jieyu Decoction

[0067] 1) Weigh 10g of Pinellia ternata, 10g of Magnolia officinalis, 10g of Poria cocos, 15g of Sophora flavescens, 20g of Aster tataricus, 15g of Citron, 10g of Rose Flos, 20g of Chicken Gizzard Stone, 15g of Ginger, 10g of Bletilla striata, 3g of Panax notoginseng, and 5g of Menthol. Add enough water to cover all the herbs and soak for 30 minutes.

[0068] 2) Bring to a boil over high heat, then simmer over low heat for 30 minutes, and filter out the first medicinal liquid;

[0069] 3) Add water to cover the remaining medicinal residue, boil over high heat, then simmer over low heat for 30 minutes, and filter out the second medicinal liquid;

[0070] 4) Combining the first medicinal liquid and the second medicinal liquid to form a decoction.

[0071] 2. Preparation of solution spray

[0072] 1) Weigh 10g of Pinellia ternata, 10g of Magnolia officinalis, 10g of Poria cocos, 15g of Sophora flavescens, 20g of Aster tataricus, 15g of Citron, 10g of Rose flower, 20g of Chicken Gizzard Stone, 15g of Ginger, 10g of Bletilla striata, 3g of Panax notoginseng, and 5g of Menthol.

[0073] 2) The above Chinese medicines were decocted and concentrated to obtain a paste with a relative density of about 1.20.

[0074] 3) The obtained paste was dissolved in 100 ml of sterile water, mixed well, and filtered to remove impurities and insoluble matter to obtain a clear solution.

[0075] 4) Dispense the clear solution into a nebulizer.

[0076] Example 2: Clinical trial

[0077] 1. Study Design

[0078] 1.1 Types of research designs

[0079] This part adopts a randomized parallel controlled, interventional study design type.

[0080] 1.2 Sample size

[0081] The sample size of this study was calculated to be a minimum of 30 cases. Taking into account the dropout rate of 20%, this study took N1=N2=36 cases, for a total of 72 cases.

[0082] 1.3 Random Methods

[0083] A computer randomization method was used to generate 72 random integers using the randbetween function in Excel. Patients with odd numbers were assigned to the experimental group and those with even numbers were assigned to the control group according to their visit order.

[0084] 1.4 Covert Grouping Method and Process

[0085] The random grouping scheme was kept in a light-proof envelope. The envelopes were opened in sequence according to the order of enrollment, and the patients' grouping was determined according to the allocation scheme in the envelope.

[0086] 1.5 Blind method

[0087] This study is a randomized controlled clinical trial. During the research process, the principle of separation of researchers, operators and statisticians was implemented.

[0088] 2. Research subjects

[0089] 2.1 Subject recruitment

[0090] A total of 72 patients with plum pit qi were recruited by posting recruitment advertisements in the spleen and stomach disease clinic of Shaanxi Provincial Hospital of Traditional Chinese Medicine and posting on WeChat Moments.

[0091] Recruitment period: August 2021 to February 2022.

[0092] 2.2 Diagnostic criteria

[0093] Refer to the diagnostic criteria for globus hysterica in Rome III (Functional Gastrointestinal Disorders 2007):

[0094] (1) Continuous or intermittent painless mass or foreign body sensation in the throat;

[0095] (2) The sensation occurs between meals;

[0096] (3) no dysphagia or odynophagia;

[0097] (4) there is no evidence of gastroesophageal acid reflux causing the symptoms;

[0098] (5) No histopathologically based esophageal motility disorder.

[0099] *Symptoms occurred for at least 6 months before diagnosis, and the above criteria were met in the past 3 months.

[0100] 2.3 Inclusion criteria

[0101] ① Meet the diagnostic criteria for globus hysterica according to Rome III (Functional Gastrointestinal Disorders 2007);

[0102] ② Female patients aged 18-60 years;

[0103] ③Years of education ≥12 years;

[0104] ④ Sign the informed consent form;

[0105] ⑤Female patients with no smoking history.

[0106] 2.4 Exclusion criteria

[0107] ①Male patients;

[0108] ② Insomnia associated with other mental illnesses (depression, anxiety, schizophrenia, bipolar disorder, etc.), physical illnesses (pain, stroke, coronary heart disease, tumor, etc.);

[0109] ③Combined with severe depression and anxiety (PHQ-9 depression screening ≥20; GAD-7 anxiety screening ≥19);

[0110] ④ Those suffering from severe or unstable chronic diseases that are not well controlled;

[0111] ⑤ Patients with severe gastroesophageal reflux disease;

[0112] ⑥Patients with severe cardiopulmonary impairment;

[0113] ⑦ Have a history of central nervous system diseases such as epilepsy, brain tumor, hemangioma, encephalitis, acute brain injury, etc.

[0114] 3. Research Methods

[0115] 3.1 Intervention measures

[0116] 3.1.1 Grouping

[0117] ① The Xingqi Jieyu Decoction treatment group, in which the dosage of Xingqi Jieyu Decoction was one dose per day, divided into two doses.

[0118] ② Waiting treatment group: no intervention during the observation period.

[0119] 3.1.2 Basic treatment

[0120] Both groups received basic education on globus hysterica according to Rome III (Functional Gastrointestinal Disorders 2007):

[0121] During the first treatment, the therapist gave the patient a brochure on plum pit qi and conducted about 30 minutes of education and communication, trying to make the patient understand the content of the education as much as possible and asking the patient to try to implement it during the study.

[0122] 3.1.3 Treatment course

[0123] Both groups received 2 weeks of treatment / observation.

[0124] 3.1.4 Emergency Plan

[0125] During the study, any antidepressants, antianxiety drugs, antipsychotic drugs, and mood stabilizers were prohibited. If the globus globus symptoms worsened during the study, according to ethical requirements, alternative treatment was: sublingual Pudilan Anti-inflammatory Oral Liquid (Manufacturer: Jichuan Pharmaceutical Group Co., Ltd., Product Batch No.: 2404216, Specification: 10ml x 10 bottles) per time.

[0126] If the subjects use alternative drugs during the study, they need to record the number of times and dosage of the alternative drugs used in detail.

[0127] 3.3 Observation indicators

[0128] 3.3.1 General information collection

[0129] This part of the study collected general information of patients with globus ulmoides: gender, age, years of education, and disease course (months).

[0130] 3.3.2 Assessment of emotional symptoms

[0131] ① Beck Depression Inventory (BDI)

[0132] A self-rating scale specifically designed to assess depression severity. The scale consists of 21 items, rated on a four-point scale, primarily used to assess the degree to which a participant experiences various depressive symptoms. The total score is calculated by summing the scores of the 21 items. A total score of 0-5 indicates a healthy state, 10-15 indicates mild depressive symptoms, >15 indicates depressive symptoms, and >25 indicates severe or critical depressive symptoms.

[0133] ② Beck Anxiety Inventory (BAI)

[0134] This self-rating scale specifically measures anxiety. It consists of 21 items, rated on a four-point scale, and is used to assess the degree to which a participant experiences various anxiety symptoms. The total score is calculated by summing the scores of the 21 items. A total score of 15-25 indicates mild anxiety, 26-35 indicates moderate anxiety, and >36 indicates severe anxiety.

[0135] 3.3.3 Evaluation criteria - TCM syndrome evaluation: formulated with reference to the "Guiding Principles for Clinical Research of New Chinese Medicines" (China Medical Science and Technology Press, 2002).

[0136] Clinical recovery: symptoms and signs disappear or almost disappear, efficacy index ≥ 95%;

[0137] Markedly effective: symptoms and signs are significantly improved, with efficacy index ≥ 70%;

[0138] Effective: symptoms and signs are improved, with efficacy index ≥30%;

[0139] Invalid: Failure to meet the above-mentioned validity criteria or deterioration.

[0140] The efficacy index = (pre-treatment score - post-treatment score) / pre-treatment score × 100%. The TCM symptom quantification grading scale is as follows: no symptoms (0 points); mild (1 point): mild symptoms that are only felt when paying attention and do not affect daily life, work, or study; moderate (2 points): symptoms are tolerable but have partially affected daily life, work, and study; severe (3 points): symptoms are obvious and unbearable, significantly affecting daily life, work, and study.

[0141] 3.3.4 Evaluation method and time

[0142] Evaluation method: On the first outpatient clinic day, weekly follow-up visits, and at the end of the 2-week experiment, evaluation was conducted based on the main single symptoms and TCM syndrome evaluation standards.

[0143] 3.4 Statistical analysis

[0144] SPSS 22.0 software was used for data analysis. The two-sided α = 0.05 was used as the test level, and P < 0.05 was considered statistically significant.

[0145] Descriptive analysis of baseline data: calculation of quantitative data Median, interquartile range (P75-P25), minimum and maximum values; composition ratio and rate were calculated for count data.

[0146] Analysis of effect indicators: For quantitative data analysis, the mean and standard deviation of each test indicator were calculated. Paired t-tests (or Wilcoxon Signed Ranks Test) were used for comparisons between the treatment and control groups. Intergroup comparisons of quantitative data were performed using t-tests (or 95% confidence intervals). For non-normal distributions and unequal variances, the Mann-Whitney U test was used.

[0147] 4. Research Results

[0148] 4.1 Baseline Data Analysis

[0149] A total of 72 subjects were included in this study, and 65 of them completed the entire trial.

[0150] Group 1 was the treatment group (Xingqi Jieyu Decoction) with a total of 33 cases, and Group 2 was the blank control group (waiting for treatment group) with a total of 32 cases.

[0151] Table 1 Baseline data

[0152]

[0153] The results of the two independent sample t-test showed that there was no statistically significant difference in age between the two groups.

[0154] The results of the Mann-Whitney U rank sum test showed that there was no statistically significant difference in years of education and disease course between the two groups.

[0155] 4.2 Effects on Plum-pit Qi Symptoms and Emotions

[0156] 4.2.1 Patients and their own reports

[0157] Patient 1: Sun, female, 36 years old; before treatment, she had a foreign body sensation in the throat, could not spit out or swallow, had chest and abdominal distension, sighed, had a red tongue with a white and greasy coating, and a stringy pulse; after taking the Chinese medicine preparation of the present invention for 7 days, the foreign body sensation in the throat was basically relieved, the chest and abdominal distension was alleviated, and the other symptoms disappeared, and she was cured. So far, no foreign body sensation in the throat, throat discomfort and other symptoms have been seen.

[0158] Patient 2: Yuan, female, 34 years old; before treatment, due to increased work pressure, she had a foreign body sensation in the throat, chest and flank distension, irregular menstruation, dry and loose stools, a tingling tongue, a white tongue coating, and a stringy and slippery pulse; after taking the Chinese medicine preparation of the present invention for 4 days, the foreign body sensation in the throat was basically relieved, and after taking it for 3 more days, the chest and flank distension was relieved, and the other symptoms disappeared, and she was cured. So far, no foreign body sensation in the throat, throat discomfort, or other symptoms have been reported.

[0159] Patient 3: Duan, female, 21 years old; before treatment, she developed throat discomfort, foreign body sensation in the throat, irritability, red tongue, thin yellow fur, and stringy pulse due to declining academic performance; after taking the Chinese medicine preparation of the present invention for 3 days, her mood gradually stabilized, and after continuing to take the medicine for 4 days, all symptoms disappeared and she was cured. So far, no obvious symptoms of abnormal throat discomfort have appeared.

[0160] Patient 4, Kang, female, 56 years old; before treatment, she had a quarrel with her neighbor and developed pharyngeal discomfort, sighing, chest tightness, loss of appetite, red tongue, white fur, and a stringy and slippery pulse; after taking the Chinese medicine preparation of the present invention for 4 days, the foreign body sensation in the pharynx was basically relieved, and after taking it for 3 days, the chest and flank distension was relieved, and the other symptoms disappeared, and she was cured, and there is no obvious discomfort in the pharynx to date.

[0161] Patient 5, Liang, female, 32 years old; before treatment, she was repeatedly urged to get married by her family because she was undecided about her marriage, and subsequently developed a foreign body sensation in the throat, irregular menstruation, chest and flank discomfort, sighing, insomnia and irritability, a red tongue, a thin yellow fur, and a stringy and slippery pulse; after taking the Chinese medicine preparation of the present invention for 3 days, her mood gradually stabilized, and after continuing to take the medicine for 4 days, all symptoms disappeared and she was cured, and has not experienced symptoms such as a foreign body sensation in the throat and throat discomfort to date.

[0162] Among 33 female patients who were treated with the Chinese medicine composition of the present invention for one course of treatment (14 days), 23 were completely cured and their indicators returned to normal; 8 had symptom relief; 2 were ineffective, with an overall effective rate of 93.94% and no recurrence.

[0163] 4.2.2 Comparison of plum pit qi symptom scores

[0164] Table 2 Symptom scores and change values ​​before and after treatment of plum pit qi Analysis of the efficacy before and after treatment

[0165]

[0166] Note: *Compared with the control group after treatment, t=-10.321, P<0.0001, the difference is statistically significant.

[0167] The two independent sample t-test method was used, and the results showed that the baseline symptoms of the two groups were the same, among which there was a statistically significant difference between the patients with plum pit qi in the treatment group and the control group after treatment, which shows that the Chinese medicine composition of the present application can effectively relieve the symptoms of plum pit qi.

[0168] 4.2.3 Comparison of anxiety and depression symptoms

[0169] Table 3 Analysis of anxiety and depression symptoms before and after treatment

[0170]

[0171] Note: *Compared with the control group, P < 0.0001, the difference is statistically significant.

[0172] The rank sum test (Mann-Whitney U) method was used, and the results showed that the BDI and BAI of the two groups were the same at baseline, and the differences in BDI and BAI after treatment were statistically significant compared with the control group.

[0173] 5. Summary

[0174] ①Baseline data

[0175] The baseline characteristics of the Qi-promoting and relieving depression group for patients with liver depression and qi stagnation of plum-shaped qi in this study were: all female patients, mean age 40.48±11.28 years, mean years of education 14.91±2.14, mean BDI 8.73±3.49, and mean BAI 28.64±5.06. The baseline characteristics of the blank control group for plum-shaped qi were: all female patients, mean age 40.56±11.56 years, mean years of education 14.94±2.17, mean BDI 8.56±3.42, and mean BAI 27.97±5.15.

[0176] ②Efficacy indicators

[0177] The intervention measure (administration of Xingqi Jieyu Decoction) improved the symptoms and scores in the treatment group, and significantly decreased the values ​​of BDI and BAI.

[0178] in conclusion

[0179] Xingqi Jieyu Decoction can effectively improve the clinical symptoms and scores of plum pit qi, relieve anxiety and depression, and effectively reduce the recurrence of plum pit qi.

Claims

1. A Chinese medicine composition for treating liver depression and qi stagnation type plum pit qi, comprising: Pinellia, Magnolia officinalis, Poria, Sophora flavescens, Aster, Buddha's hand, and rose; Preferably, the pinellia is qing pinellia.

2. The Chinese medicine composition according to claim 1, further comprising: Chicken gizzard lining, ginger, Bletilla striata, Panax notoginseng and mint.

3. The Chinese medicine composition according to claim 1 or 2, comprising: 10-12 servings of Pinellia ternata, 8-10 parts of Magnolia officinalis, 10-12 parts of Poria cocos, 10-15 parts of Sophora flavescens, 15-20 parts of Aster tataricus, 10-15 parts of Citron, 10-12 parts of Rose, 15-20 parts of Chicken's Gizzard Stone, 10-15 parts of Ginger, 10-12 parts of Bletilla striata, 3-4 parts of Panax notoginseng, and 5-6 parts of Mint. The parts of each Chinese medicine are by weight.

4. The Chinese medicine composition according to claim 3, comprising: 10 parts of Pinellia, 10 parts of Magnolia officinalis, 10 parts of Poria, 15 parts of Sophora flavescens, 20 parts of Aster, 15 parts of Citron, 10 parts of Flos Rosae Rugosae, 20 parts of Chicken's Gizzard Stones, 15 parts of Zingiber officinale, 10 parts of Bletilla striata, 3 parts of Radix Notoginseng, 5 parts of Menthol.

5. A traditional Chinese medicine preparation, which is prepared from the traditional Chinese medicine composition according to any one of claims 1 to 4.

6. The Chinese medicine preparation according to claim 5, wherein the Chinese medicine preparation is a decoction, a spray, a granule, a lozenge or a powder.

7. The Chinese medicine preparation according to claim 6, wherein the Chinese medicine preparation is a spray.

8. The Chinese medicine preparation according to claim 7, wherein the spray is prepared by the following method: 1) decocting the various Chinese medicinal herbs in the Chinese medicinal composition into a decoction, and then concentrating and filtering the decoction to obtain a clear solution for the spray; or 2) boiling and concentrating the various Chinese medicinal herbs in the Chinese medicinal composition into a clear paste, then dissolving the clear paste in a solvent such as sterile saline or sterile water, mixing well, and filtering to obtain a clear solution as the spray.

9. Use of the Chinese medicine composition according to any one of claims 1 to 4 or the Chinese medicine preparation according to any one of claims 5 to 8 in preparing a medicament for treating liver depression and qi stagnation type plum pit qi.

10. The use according to claim 9, wherein the drug is used in combination with other western medicines such as anti-anxiety and antidepressant drugs to treat liver depression and qi stagnation type plum pit qi.

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