Traditional Chinese medicine composition for treating obstructive sleep apnea hypopnea syndrome, preparation method and application thereof

Abstract

This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition for treating obstructive sleep apnea-hypopnea syndrome (OSAHS), its preparation method, and its application. The traditional Chinese medicine composition of this invention comprises, by weight, the following raw materials: Astragalus membranaceus 10-30 parts, Citrus reticulata peel 5-10 parts, Poria cocos 10-20 parts, Pinellia ternata 5-15 parts, Prunus armeniaca 10-15 parts, Ligusticum chuanxiong 10-15 parts, Curcuma longa 5-15 parts, and Glycyrrhiza uralensis 3-10 parts. Animal experiments have shown that the traditional Chinese medicine composition of this invention can effectively improve lung function in OSAHS mice induced by chronic intermittent hypoxia and effectively improve the pathological changes in the bronchi and lung tissues of OSAHS mice. This suggests that the traditional Chinese medicine composition of this invention has a good therapeutic effect on OSAHS.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition for treating obstructive sleep apnea-hypopnea syndrome, its preparation method, and its application. Background Technology

[0002] Repeated upper airway obstruction during nighttime sleep induces a disease characterized primarily by apnea and hypoxemia, defined as obstructive sleep apnea-hypopnea syndrome (OSAHS). This disease involves multiple pathogenic mechanisms, which are not yet fully understood. In my country, the incidence rate is approximately 4% and continues to rise. OSAHS complications affect numerous systems and organs throughout the body, such as the cardiovascular, endocrine, metabolic, renal, and cognitive impairments, leading to a sharp increase in mortality. Because the disease is accompanied by daytime sleepiness and drowsiness, it significantly increases the incidence of motor vehicle and industrial accidents on roads. Currently, a large number of people suffer from OSAHS, requiring substantial annual economic expenditure for its prevention and treatment, making it a focal point of global public health issues.

[0003] Currently, modern medicine primarily treats this disease using methods such as continuous positive airway pressure (CPAP), sleep mouthpieces, and surgery. CPAP is a highly effective treatment and is recommended as the first-line option by the 2011 Chinese and 2013 American OSAHS guidelines. However, CPAP can cause a range of side effects (such as facial skin irritation, nasal congestion, runny nose, increased intraocular pressure, abdominal distension, claustrophobia, dry mouth, etc.), and the treatment process is complex, often leading to patient discontinuation due to lack of long-term adherence. Furthermore, patients' fear of developing ventilator dependence contributes to poor compliance, hindering its widespread use. Sleep mouthpieces, on the other hand, are inexpensive and simple to use, but long-term use can lead to loose teeth, periodontal inflammation, and jaw discomfort. Surgical treatments include uvulopalatopharyngoplasty (UPPP) and the improved H-UPPP procedure. The surgical site is the palatopharyngeal region. Due to the risks of palatopharyngeal stenosis and incomplete closure of the palatopharynx after surgery, as well as the discomfort and pain after surgery and a series of subsequent complications, patients still find it difficult to accept.

[0004] Due to poor adherence to treatments such as CPAP, sleep mouthpieces, and surgery, an increasing number of OSAHS patients are placing their hopes on Traditional Chinese Medicine (TCM). TCM possesses unique advantages in treating OSAHS due to its multi-target efficacy and fewer side effects. However, currently, most TCM compositions used clinically to treat OSAHS are derived from existing prescriptions with modifications, and are not specifically developed to address the etiology and pathogenesis of OSAHS, thus limiting their therapeutic efficacy. Therefore, there is an urgent need to develop a TCM composition that can effectively treat OSAHS to meet clinical needs. Summary of the Invention

[0005] The first objective of this invention is to provide a traditional Chinese medicine composition for treating obstructive sleep apnea-hypopnea syndrome; the second objective of this invention is to provide a method for preparing the traditional Chinese medicine composition; and the third objective of this invention is to provide the application of the traditional Chinese medicine composition.

[0006] According to a first aspect of the present invention, a traditional Chinese medicine composition for treating obstructive sleep apnea-hypopnea syndrome is provided, wherein the raw materials comprising, by weight, are: 10-30 parts of Astragalus membranaceus, 5-10 parts of Citrus reticulata peel, 10-20 parts of Poria cocos, 5-15 parts of Pinellia ternata, 10-15 parts of Prunus armeniaca, 10-15 parts of Ligusticum chuanxiong, 5-15 parts of Curcuma longa, and 3-10 parts of Glycyrrhiza uralensis.

[0007] This invention suggests that the causes of obstructive sleep apnea-hypopnea syndrome (OSAHS) include the following: ① Congenital deficiencies: Cranial skeletal deformities, such as deviated nasal septum or mandibular retrusion, cause airway narrowing, easily leading to snoring. ② Improper diet: Obese people tend to eat rich, fatty, and greasy foods, which impairs the function of the middle jiao (middle burner), causing phlegm, fluid retention, and dampness to overflow into the limbs and fill the throat and orifices, leading to airway narrowing and collapse, resulting in obstructed qi flow and snoring. ③ External pathogenic factors: Healthy individuals may develop the disease when exposed to these pathogenic factors, which invade the lungs, throat, and nasal passages, causing obstructed lung qi flow, nasal passages, and throat, and impaired qi flow, easily leading to snoring; in individuals with snoring, exposure to these pathogenic factors exacerbates airway narrowing and collapse, disrupting the flow of qi, and intensifying snoring. ④ Weak constitution: People with pre-existing illnesses have deficiencies in the Qi of the five internal organs, especially the lungs and kidneys. The lungs govern the dispersal and descent of Qi, while the kidneys govern the intake of Qi. If the breathing is not in harmony, the Qi will not flow smoothly. In addition, if the spleen Qi is deficient and the muscles are not full, the muscles of the airway will be weak and prone to collapse, resulting in snoring.

[0008] The pathogenesis of OSAHS (Obstructive Sleep Apnea-Hypopnea Syndrome) is fundamentally based on the deficiency of Qi in the lungs, spleen, and kidneys, with phlegm, blood stasis, and Qi stagnation as secondary manifestations. The lungs reside in the upper Jiao (upper burner), the spleen in the middle Jiao, and the kidneys in the lower Jiao. Because the spleen, as the middle Jiao, acts as a pivot and link between the upper and lower Jiao, it is the primary organ affected by this condition. Spleen deficiency leads to impaired transformation and transportation of nutrients, easily generating phlegm and dampness. When this phlegm and dampness accumulates throughout the body, it causes obesity; when it accumulates in the airways, it causes narrowing or even obstruction, resulting in abnormal Qi flow and symptoms such as snoring and shortness of breath during sleep. The spleen governs the muscles of the limbs, and the airways also fall under the category of muscles. Spleen deficiency causes the muscles of the airways to lose lubrication, making them prone to collapse and deformation, obstructing the ascending and descending flow of Qi, and causing snoring during sleep. Spleen deficiency easily leads to the production of phlegm and dampness, which obstructs the flow of Qi in the local area. When Qi is not flowing smoothly, it becomes stagnant. The stagnation of Qi and the exacerbation of phlegm and dampness can eventually lead to blood stasis. These three factors are mutually pathological, further hindering the flow of Qi in the body and affecting the functions of the lungs in governing Qi and the kidneys in governing the intake of Qi, resulting in the involvement of multiple organs and viscera.

[0009] This formula uses Astragalus membranaceus as the chief ingredient, which has the effect of greatly replenishing vital energy and is designed for those with snoring who are often deficient in qi. Citrus reticulata peel, Poria cocos, and Pinellia ternata have the effects of drying dampness, resolving phlegm, regulating qi, and harmonizing the middle jiao. Apricot kernel disperses lung qi and opens up the phlegm-qi stagnation in the upper jiao; these four are the assistant ingredients. Ligusticum chuanxiong is pungent and warm, invigorating blood and promoting qi circulation; it is a qi-regulating herb in the blood. Curcuma longa is pungent and dispersing, bitter and cold, opening the orifices, invigorating blood, clearing the heart, relieving depression, and promoting qi circulation; these two herbs together promote the smooth flow of qi and blood, serving as adjuvant ingredients. Licorice root replenishes heart qi and benefits spleen qi; it is the guiding ingredient in the formula. All the herbs in the formula work together to invigorate qi, invigorate blood, resolve phlegm, and open the obstructions, which aligns with the pathogenesis of OSAHS (qi deficiency and phlegm-blood stasis).

[0010] The raw materials for this invention are sourced as follows:

[0011] Astragalus: The dried root of Astragalus membranaceus (Fisch.) Bge. var. mongholicus (Bge.) Hsiao or Astragalus membranaceus (Fisch.) Bge., belonging to the legume family.

[0012] Orange peel: The dried outer peel of the orange plant (Citrus reticulata) and its cultivated varieties, belonging to the Rutaceae family.

[0013] Poria: The dried sclerotium of the fungus Poria cocos (Schw.) Wolf, belonging to the Polyporaceae family.

[0014] Pinellia: The dried tuber of Pinellia ternata (Thunb.) Breit., a plant of the Araceae family.

[0015] Almonds: the bitter, dried seeds of apricot or wild apricot trees, belonging to the Rosaceae family.

[0016] Chuanxiong: The dried rhizome of Ligusticum chuanxiong Hort. (or Ligusticum wallichii Franch.), a plant of the Apiaceae family.

[0017] Turmeric: The dried tuberous roots of Curcuma wenyujin YHChen et C.Ling, Curcuma longa L., Curcuma kwangsiensis SGLee et CFLiang, or Curcuma phaeocaulis Val., all belonging to the ginger family.

[0018] Licorice: The dried root of Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat., or Glycyrrhiza glabra L., all belonging to the legume family.

[0019] In some embodiments, the raw material composition by weight includes: 30 parts Astragalus membranaceus, 5 parts Citrus reticulata peel, 20 parts Poria cocos, 10 parts Pinellia ternata, 15 parts Prunus armeniaca, 15 parts Ligusticum chuanxiong, 10 parts Curcuma longa, and 10 parts Glycyrrhiza uralensis.

[0020] In some implementations, the orange-red is chemically modified orange-red.

[0021] In some embodiments, the dosage form of the traditional Chinese medicine composition is an ointment, decoction, pill, granule, capsule, tablet, drop pill, oral liquid, injection, or powder. Therefore, the present invention can be administered via oral, injection, sublingual, rectal, transdermal, or aerosol inhalation routes to meet the medication needs of different patients. The dosage based on raw medicinal materials is 58-130 grams / day, and the specific dosage can be adjusted according to the patient's condition.

[0022] In some implementations, medically acceptable excipients may also be added.

[0023] According to a second aspect of the present invention, a method for preparing the above-mentioned traditional Chinese medicine composition is provided, wherein when the dosage form of the traditional Chinese medicine composition is an ointment, the preparation method includes the following steps:

[0024] Weigh the raw materials according to the formula, add 8-10 times their weight of water, soak for 1-2 hours, then heat to boiling and maintain a gentle boil for 0.5-1 hours, filter to obtain the first residue and the first filtrate, then add 8-10 times their weight of water to the first residue, heat to boiling and maintain a gentle boil for 0.5-1 hours, filter to obtain the second residue and the second filtrate, combine the first and second filtrates and concentrate to a specific gravity of 1.2-1.3 when heated at 40-70°C to obtain the first thick paste, then cool to room temperature, add ethanol to a specific gravity of 70-85%, let stand for 20-30 hours, filter, recover the ethanol, concentrate to a specific gravity of 1.4-1.5 when heated at 40-70°C to obtain the second thick paste, which is the final product.

[0025] According to a third aspect of the present invention, the use of the above-described traditional Chinese medicine composition in the preparation of a medicament for treating obstructive sleep apnea-hypopnea syndrome is provided.

[0026] The beneficial effects of this invention include:

[0027] (1) Animal experiments showed that the traditional Chinese medicine composition of the present invention can effectively improve lung function in OSAHS mice induced by chronic intermittent hypoxia and effectively improve the pathological changes in the bronchial and lung tissues of OSAHS mice. This suggests that the traditional Chinese medicine composition of the present invention has a good therapeutic effect on OSAHS.

[0028] (2) The traditional Chinese medicine composition of the present invention can significantly improve symptoms such as snoring during sleep, morning sleepiness, forgetfulness, chest tightness, and dry mouth in OSAHS patients. It can also significantly improve polysomnography indicators such as the hypoventilation index (AHI), the lowest nocturnal oxygen saturation (LSp O2), and nocturnal sleep apnea-hypopnea, thereby improving the hypoxia caused by upper airway obstruction in OSAHS patients and significantly improving their quality of life. No serious toxic reactions occurred during administration, and the safety profile was good. Attached Figure Description

[0029] Figure 1 The results of the animal experiments of this invention on the effect of the Astragalus and Citrus Anti-Snoring Formula on the respiratory rate of OSAHS mice.

[0030] Figure 2 The results of the animal experiments of this invention on the effect of the Astragalus and Citrus Anti-Snoring Formula on tidal volume in OSAHS mice.

[0031] Figure 3 The results of the animal experiments of this invention on the effect of the Astragalus and Citrus Anti-Snoring Formula on the end-inspiratory apnea time of OSAHS mice.

[0032] Figure 4 The results of the animal experiments of this invention on the pathological effects of the Astragalus and Citrus Anti-Snoring Formula on the bronchi and lung tissues of mice. Detailed Implementation

[0033] The present invention will be further described in detail below with reference to specific embodiments. It is worth noting that the following embodiments are only for better explaining the content of the present invention and do not limit the scope of protection of the present invention. Process steps not disclosed in the embodiments are prior art. Unless otherwise specified, all raw materials are commercially available.

[0034] Example 1

[0035] The traditional Chinese medicine decoction for treating obstructive sleep apnea-hypopnea syndrome in this embodiment consists of the following ingredients by weight: Astragalus membranaceus 30g, Citrus reticulata peel 5g, Poria cocos 20g, Pinellia ternata 10g, Prunus armeniaca 15g, Ligusticum chuanxiong 15g, Curcuma longa 10g, and Glycyrrhiza uralensis 10g.

[0036] Its preparation method includes the following steps:

[0037] Weigh the raw materials according to the formula, add 10 times the weight of water, soak for 1 hour, then heat to boiling and maintain a gentle boil for 50 minutes, filter to obtain the first filter residue and the first filtrate, then add 8 times the weight of water to the first filter residue, heat to boiling and maintain a gentle boil for 50 minutes, filter to obtain the second filter residue and the second filtrate, combine the first filtrate and the second filtrate to obtain the final product.

[0038] The traditional Chinese medicine decoction prepared in this embodiment is a single dose, which is approximately 300 mL.

[0039] In addition, other conventional methods for preparing traditional Chinese medicine decoctions can also be used to obtain the traditional Chinese medicine decoction of the present invention, which will not be listed here.

[0040] Example 2

[0041] The traditional Chinese medicine ointment for treating obstructive sleep apnea-hypopnea syndrome in this embodiment consists of the following ingredients by weight: Astragalus membranaceus 30g, Citrus reticulata peel 5g, Poria cocos 20g, Pinellia ternata 10g, Prunus armeniaca 15g, Ligusticum chuanxiong 15g, Curcuma longa 10g, and Glycyrrhiza uralensis 10g.

[0042] Its preparation method includes the following steps:

[0043] After obtaining the traditional Chinese medicine decoction according to the preparation method of Example 1, the decoction was concentrated to a specific gravity of 1.2 when measured at 55°C to obtain a first thick paste. The paste was cooled to room temperature, and then ethanol was added to a content of 70%. After standing for 24 hours, the paste was filtered, the ethanol was recovered, and the paste was concentrated to a specific gravity of 1.5 when measured at 55°C to obtain a second thick paste.

[0044] In addition, other conventional methods for preparing traditional Chinese medicine ointments can also be used to obtain the ointment of the present invention, which will not be listed here.

[0045] Example 3

[0046] The traditional Chinese medicine decoction for treating obstructive sleep apnea-hypopnea syndrome in this embodiment consists of the following ingredients by weight: Astragalus membranaceus 20g, Citrus reticulata peel 8g, Poria cocos 15g, Pinellia ternata 15g, Prunus armeniaca 13g, Ligusticum chuanxiong 12g, Curcuma longa 15g, and Glycyrrhiza uralensis 7g.

[0047] Its preparation method is the same as that of Example 1.

[0048] Example 4

[0049] The traditional Chinese medicine ointment for treating obstructive sleep apnea-hypopnea syndrome in this embodiment consists of the following ingredients by weight: Astragalus membranaceus 10g, Citrus reticulata peel 10g, Poria cocos 10g, Pinellia ternata 5g, Prunus armeniaca 10g, Ligusticum chuanxiong 10g, Curcuma longa 5g, and Glycyrrhiza uralensis 3g.

[0050] Its preparation method is the same as that in Example 2.

[0051] Below, the therapeutic effect of the traditional Chinese medicine composition for treating obstructive sleep apnea-hypopnea syndrome (hereinafter referred to as Qi Ju Zhi Xiang Fang) of the present invention on OSAHS was evaluated using a mouse OSAHS model induced by chronic intermittent hypoxia.

[0052] 1. Laboratory animals

[0053] Thirty male Balb / c mice, weighing 18-22g, were purchased from the Guangdong Provincial Medical Animal Experiment Center.

[0054] 2. Experimental Methods

[0055] (1) Animal grouping and intervention

[0056] Thirty Balb / c mice were randomly divided into five groups of six each: blank control group, OSAHS model group, low-dose group of Qi Ju Zhihan Fang (QJZH low-dose group), medium-dose group of Qi Ju Zhihan Fang (QJZH medium-dose group), and high-dose group of Qi Ju Zhihan Fang (QJZH high-dose group).

[0057] A mouse model of chronic intermittent hypoxia-induced OSAHS was established using an acrylic glass chamber. Mice were placed in the intermittent hypoxia chamber daily from 8:00 am to 4:00 pm. The chamber was circulated with nitrogen and compressed air, with a cycle of 90 seconds of nitrogen followed by 90 seconds of compressed air, for a total of 180 seconds per cycle. The gas flow rate was adjusted to maintain a minimum O2 concentration of 5% in each cycle, then gradually restored to 21%, and then reduced back to 5%, repeating this cycle. The chamber pressure was atmospheric pressure.

[0058] The blank control group was continuously given normoxic air at an O2 concentration of 21%. All other groups were given chronic intermittent hypoxia treatment according to the modeling method described above. All groups were given normal food and water during non-experimental hours (4:00 pm - 8:00 am) for a total of 6 weeks.

[0059] Each group was administered medication simultaneously with model establishment. The medication administration details for each group are as follows:

[0060] ①OSAHS model group: Administered an equal volume of 0.9% saline by gavage;

[0061] ② Blank control group: Administered an equal volume of 0.9% saline via gavage;

[0062] ③ Low, medium, and high dose groups of the Astragalus and Citrus Anti-Snoring Formula: The traditional Chinese medicine decoction of Example 1 was administered by gavage. The drug concentration of the low dose group of the Astragalus and Citrus Anti-Snoring Formula was 2.2 g / kg, the drug concentration of the medium dose group was 4.4 g / kg, and the drug concentration of the high dose group was 8.8 g / kg.

[0063] All groups were given the medication once daily for 6 consecutive weeks.

[0064] (2) Monitoring of respiratory function in mice

[0065] Lung function in mice was measured using the EMKA animal lung function monitoring system, with a pre-measurement calibration system. Mice were placed in a full-volume recording chamber for 5-10 minutes to acclimatize, and data was recorded for 3-8 minutes. Various lung function indicators were measured, and the average value of the results for each mouse within this time period was taken as the lung function measurement result. Lung function was measured every 2 weeks.

[0066] (3) Pathological observation of mouse bronchial and lung tissues

[0067] The bronchial and lung tissues of mice in each group were collected, fixed, dehydrated and cleared, embedded in paraffin, sectioned and mounted, dewaxed and stained, hematoxylin and eosin (HE) stained, dehydrated and cleared and mounted, and the morphology of the bronchial and lung tissues was observed under a microscope.

[0068] 3. Statistical methods

[0069] Results are expressed as mean ± standard error (Mean ± SEM) and analyzed using SPSS 17.0 software. Differences between groups were compared using one-way ANOVA (without assuming homogeneity of variance, Dunnett's T3). P < 0.05 was considered statistically significant.

[0070] 4. Results

[0071] (1) Effects of Astragalus and Tangerine Antisnoring Formula on Lung Function in Mice

[0072] The effect of Astragalus and Tangerine Anti-Snoring Formula on respiratory rate in OSAHS mice is as follows: Figure 1 As shown in the figure, *** indicates P < 0.001, and ** indicates P < 0.01. From Figure 1 It can be seen that, compared with the blank control group, the respiratory rate of mice in the OSAHS model group was significantly increased (P<0.001). This is because after modeling, mice experience more respiratory distress due to airway obstruction and persistent hypoxemia. Compared with the OSAHS model group, the respiratory rate of mice in the low-dose group of Qiju Zhihan Fang was significantly decreased (P<0.01), indicating that the traditional Chinese medicine composition of the present invention can effectively improve the respiratory rate of OSAHS mice induced by chronic intermittent hypoxia.

[0073] The effect of Astragalus and Tangerine Anti-Snoring Formula on Tidal Volume in OSAHS Mice is as follows: Figure 2 As shown in the figure, ** indicates P < 0.01, and * indicates P < 0.05. From Figure 2 It can be seen that, compared with the blank control group, the tidal volume of the OSAHS model group mice was significantly increased (P<0.01), which is due to the irregular breathing pattern caused by airway obstruction after modeling; compared with the OSAHS model group, the tidal volume of the medium dose group of Qiju Zhihan Fang mice was significantly reduced (P<0.05), indicating that the traditional Chinese medicine composition of the present invention can effectively reduce the tidal volume of OSAHS mice induced by chronic intermittent hypoxia.

[0074] The effect of Astragalus and Tangerine Anti-Snoring Formula on the end-inspiratory apnea time in OSAHS mice is as follows: Figure 3 As shown in the figure, ** indicates P < 0.01, and * indicates P < 0.05. From Figure 3 As can be seen, compared with the blank control group, the end-inspiratory apnea time of the OSAHS model group mice was significantly prolonged (P<0.01). This is because the mice had airway obstruction after modeling, and needed more time to overcome the airway obstruction and complete inspiration, thus resulting in a prolonged end-inspiratory apnea time. Compared with the OSAHS model group, the end-inspiratory apnea time of mice in the low, medium and high dose groups of Qiju Zhihan Fang was significantly shortened (low dose group P<0.05, medium and high dose groups P<0.01), indicating that the traditional Chinese medicine composition of the present invention can effectively shorten the end-inspiratory apnea time of OSAHS mice induced by chronic intermittent hypoxia.

[0075] (2) Effects of Astragalus and Jujube Antisnoring Formula on the bronchial and lung tissue pathology of mice

[0076] The effects of Astragalus and Tangerine Anti-Snoring Formula on the pathological characteristics of bronchial and lung tissues in mice are as follows: Figure 4 As shown in the figure, the "Astragalus and Tangerine Anti-Snoring Formula Group" refers to the dosage group of the Astragalus and Tangerine Anti-Snoring Formula. From Figure 4It can be seen that, compared with the blank control group, the OSAHS model group mice generally showed thickening of alveolar walls and bronchial tissues, inflammatory cell infiltration, edema, and hemorrhage; while the above pathological conditions in the Astragalus and Citrus Anti-Snoring Formula group mice were significantly improved. This indicates that the traditional Chinese medicine composition of the present invention can effectively improve the pathological changes of bronchial and lung tissues in OSAHS mice induced by chronic intermittent hypoxia.

[0077] 5. Conclusion

[0078] The traditional Chinese medicine composition of this invention can effectively improve lung function in OSAHS mice induced by chronic intermittent hypoxia and effectively improve the pathological changes in the bronchi and lung tissues of OSAHS mice. This suggests that the traditional Chinese medicine composition of this invention has a good therapeutic effect on OSAHS.

[0079] The above descriptions are merely some specific embodiments of the present invention. For those skilled in the art, various modifications and improvements can be made without departing from the inventive concept of the present invention, and all such modifications and improvements fall within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for treating obstructive sleep apnea-hypopnea syndrome, characterized in that, It is made from the following raw materials by weight: Astragalus membranaceus 10-30 parts, Citrus reticulata peel 5-10 parts, Poria cocos 10-20 parts, Pinellia ternata 5-15 parts, Prunus armeniaca 10-15 parts, Ligusticum chuanxiong 10-15 parts, Curcuma longa 5-15 parts, Glycyrrhiza uralensis 3-10 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, It is made from the following raw materials by weight: Astragalus membranaceus 30 parts, Citrus reticulata peel 5 parts, Poria cocos 20 parts, Pinellia ternata 10 parts, Prunus armeniaca 15 parts, Ligusticum chuanxiong 15 parts, Curcuma longa 10 parts, Glycyrrhiza uralensis 10 parts.

3. The traditional Chinese medicine composition according to claim 1 or 2, characterized in that, The orange-red color mentioned is citrus red.

4. The traditional Chinese medicine composition according to claim 1 or 2, characterized in that, The dosage form of the traditional Chinese medicine composition is ointment, decoction, pill, granule, capsule, tablet, oral liquid, injection or powder.

5. The traditional Chinese medicine composition according to claim 1 or 2, characterized in that, Medically acceptable excipients can also be added.

6. A method for preparing the traditional Chinese medicine composition according to any one of claims 1-5, characterized in that, When the dosage form of the traditional Chinese medicine composition is an ointment, its preparation method includes the following steps: Weigh the raw materials according to the formula, add 8-10 times their weight of water, soak for 1-2 hours, then heat to boiling and maintain a gentle boil for 0.5-1 hours, filter to obtain the first residue and the first filtrate, then add 8-10 times their weight of water to the first residue, heat to boiling and maintain a gentle boil for 0.5-1 hours, filter to obtain the second residue and the second filtrate, combine the first and second filtrates and concentrate to a specific gravity of 1.2-1.3 when heated to 40-70°C to obtain the first thick paste, then cool to room temperature, add ethanol to a specific gravity of 70-85%, let stand for 20-30 hours, filter, recover the ethanol, concentrate to a specific gravity of 1.4-1.5 when heated to 40-70°C to obtain the second thick paste, which is the final product.

7. The use of the traditional Chinese medicine composition according to any one of claims 1-5 in the preparation of a medicament for treating obstructive sleep apnea-hypopnea syndrome.

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