Traditional Chinese medicine composition for treating sleep apnea hypopnea syndrome as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition for treating sleep apnea hypopnea syndrome as well as a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight: 10-20 parts of bamboo shavings, 5-15 parts of coptis chinensis, 15-45 parts of reed stem, 9-21 parts of rhizoma pinellinae praeparata, 10-20 parts of mangnolia officinalis, 15-25 parts of poria cocos, 5-15 parts of magnolia flower, 5-15 parts of cocklebur fruit and 5-15 parts of radix angelicae. The traditional Chinese medicine composition disclosed by the invention has the beneficial effects that medicines with three effects of clearing heat, promoting diuresis and opening orifices are combined, the medicines are precise and appropriate, the compatibility is rigorous, and the traditional Chinese medicine composition prepared by combining the prescription on the basis of performing conventional noninvasive ventilator treatment on a patient can be used for remarkably reducing the AHI of the patient, improving the oxyhemoglobin saturation at night and improving the curative effect of the patient. And the traditional Chinese medicine composition is remarkable in treatment effect, and can greatly improve the symptoms of internal retention of damp-heat, internal retention of phlegm-dampness and blockage of clear orifices of patients.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicines, and in particular to a traditional Chinese medicine composition for treating sleep apnea hypopnea syndrome, a preparation method and application thereof. Background Art

[0002] Sleep apnea hypopnea syndrome is a chronic disease with an insidious onset, low diagnosis rate, recurrent symptoms, and the susceptibility to multiple chronic disease complications, which seriously affects the patient's daily life. Currently, sleep apnea hypopnea syndrome is generally divided into obstructive, central, and mixed types through polysomnography. It is often treated with non-invasive ventilators and adjustments to daily lifestyles. The treatment time is long, some patients find it difficult to cooperate, and the efficacy is poor.

[0003] In the existing technology, most of the current treatments for sleep apnea hypopnea syndrome are still based on non-invasive ventilator therapy, which mostly aims to improve the patient's nocturnal hypoxia and adjust the daily lifestyle to achieve the purpose of improving the patient's clinical symptoms. However, non-invasive ventilators require a long time to use, and some patients find it difficult to persist. It is also difficult to regulate the patient's body's internal signs of dampness and heat as a whole, and the clinical effect is not ideal. Summary of the invention

[0004] In order to overcome the problem in the prior art that the treatment time is long and the treatment effect is poor due to the difficulty of patients to cooperate, the present invention provides a Chinese medicine composition for treating sleep apnea hypopnea syndrome, a preparation method and its application, which can reduce AHI, significantly improve the degree of nocturnal hypoxia, significantly improve the daytime sleepiness ESS score of patients, and improve the symptoms of patients. The specific technical scheme is as follows:

[0005] The invention provides a traditional Chinese medicine composition for treating sleep apnea-hypopnea syndrome. The traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight: 10-20 parts of bamboo shavings, 5-15 parts of coptis chinensis, 15-45 parts of reed stems, 9-21 parts of pinellia ternata, 10-20 parts of magnolia bark, 15-25 parts of tuckahoe, 5-15 parts of magnolia flower, 5-15 parts of xanthium sibiricum fruit and 5-15 parts of angelica dahurica.

[0006] Preferably, the Chinese medicine composition is made of the following Chinese medicines in parts by weight: 12-18 parts of bamboo shavings, 7-12 parts of coptis chinensis, 20-35 parts of reed stems, 12-18 parts of pinellia ternata, 12-18 parts of magnolia bark, 17-22 parts of poria, 7-12 parts of magnolia flower, 8-12 parts of xanthium sibiricum and 7-12 parts of angelica dahurica.

[0007] Preferably, the Chinese medicine composition is made of the following Chinese medicines in parts by weight: 15 parts of bamboo shavings, 10 parts of coptis chinensis, 30 parts of reed stems, 15 parts of pinellia ternata, 15 parts of magnolia bark, 20 parts of poria, 10 parts of magnolia flower, 10 parts of xanthium sibiricum and 10 parts of angelica dahurica.

[0008] The Chinese medicine composition of the present invention mainly comprises three aspects of clearing away heat, promoting dampness removal and opening the orifices. The medicines with the effect of clearing heat in the prescription comprise bamboo shavings, coptis chinensis and reed stems. Among them, bamboo shavings are the main medicine, which is slightly cold in nature, sweet in taste, and enters the lung and stomach meridians, and has the functions of clearing heat and resolving phlegm, relieving restlessness and stopping vomiting, and cooling blood and stopping bleeding; coptis chinensis is the assistant medicine, which is bitter in taste and cold in nature, and enters the heart, spleen, stomach, liver, gallbladder and large intestine meridians, and has the functions of clearing heat and drying dampness, purging fire and detoxifying; reed stems are the adjuvant medicine, which is sweet in taste and cold in nature, and enters the lung and stomach meridians, and has the functions of clearing heat and purging fire, promoting body fluid and relieving thirst, relieving restlessness and stopping vomiting, and promoting diuresis; bamboo shavings, coptis chinensis and reed stems play the functions of clearing heat, drying dampness and purging fire together.

[0009] The drugs with the effect of removing dampness in the prescription include Pinellia ternata, Magnolia officinalis, and Poria cocos. Among them, Pinellia ternata is the main drug, which tastes pungent, warm in nature, and enters the spleen, stomach, and lung meridians. It has the functions of drying dampness and resolving phlegm, relieving adverse reactions and stopping vomiting, and eliminating lumps and resolving knots; Magnolia officinalis is the assistant drug, which tastes bitter and pungent, warm in nature, and enters the spleen, stomach, lung, and large intestine meridians. It has the functions of warming the middle and lowering Qi, drying dampness and eliminating phlegm; Poria cocos is the adjuvant drug, which tastes sweet and light, is neutral in nature, and enters the spleen and kidney meridians. It has the functions of removing dampness and promoting diuresis, and strengthening the spleen and calming the mind; Pinellia ternata, Magnolia officinalis, and Poria cocos work together to achieve the functions of drying dampness, eliminating phlegm, and removing dampness.

[0010] The medicines in the prescription with the effect of opening the orifices include magnolia flower, Xanthium sibiricum fruit and Angelica dahurica. Among them, magnolia flower is the main medicine, which is pungent in taste and warm in nature. It enters the lung and stomach meridians and has the function of dispelling wind and opening the orifices; Xanthium sibiricum fruit is the assistant medicine, which is pungent and bitter in taste and warm in nature. It enters the lung meridian and has the function of dispersing wind, removing dampness, opening the orifices and relieving pain; Angelica dahurica is the adjuvant medicine, which is pungent in taste and warm in nature. It enters the lung and stomach meridians and has the function of dispelling wind, opening the orifices and relieving pain, drying dampness and stopping leukorrhea, and reducing swelling and discharging pus; magnolia flower, Xanthium sibiricum fruit and Angelica dahurica work together to achieve the function of dispelling wind, removing dampness and opening the orifices.

[0011] The above medicines are used together to play the effect of clearing away heat, promoting dampness and opening the orifices. The present invention uses the medicines accurately, has strict compatibility and remarkable curative effect.

[0012] The present invention combines drugs with three effects of clearing away heat, promoting diuresis and clearing the orifices, and the drugs are used accurately and the compatibility is rigorous. On the basis of conventional non-invasive ventilator treatment for patients, the Chinese medicine composition prepared by combining the prescription can significantly reduce the patient's AHI, improve the nighttime blood oxygen saturation, reduce the daytime sleepiness, and has a significant therapeutic effect, which can greatly improve the symptoms of internal damp-heat, internal obstruction of phlegm and dampness, and obstruction of the orifices in patients.

[0013] The present invention provides a method for preparing a Chinese medicine composition for treating sleep apnea-hypopnea syndrome, comprising the following steps:

[0014] (1) Mix bamboo shavings, coptis root and reed stem to obtain a mixture 1, mix the mixture 1 with water and soak it, then boil it, keep boiling for 15-25 minutes, filter and collect the filtrate as the decoction liquid;

[0015] (2) Mixing fennel, magnolia bark and poria to obtain mixture 2, mixing mixture 2 with water and soaking, then boiling, keeping boiling for 30-40 minutes, filtering and collecting the filtrate, adding anhydrous ethanol to the filtrate until the concentration of the ethanol solution is 50-60%, filtering and removing impurities, collecting the filtrate to recover ethanol, obtaining filtrate extract 1, mixing the filtrate extract 1 with anhydrous ethanol until the concentration of the ethanol solution is 80-90%, filtering and removing impurities, collecting the filtrate to recover ethanol, and obtaining filtrate extract 2;

[0016] (3) Mixing magnolia flower, Xanthium sibiricum fruit and Angelica dahurica to obtain mixture 3, mixing mixture 3 with water and complex enzyme for enzymolysis, and heating the enzymolysis solution for reflux extraction to obtain reflux extract 1;

[0017] (4) The decoction, the filtrate extract 2 and the reflux extract 1 are mixed, concentrated into an extract, dried and ground to obtain the Chinese medicine composition.

[0018] Furthermore, the soaking time is 15 min-30 min.

[0019] Furthermore, the weight-to-volume ratio of the mixture 1 to water is (0.8-1.2) g:10 mL, and the weight-to-volume ratio of the mixture 2 to water is (0.8-1.2) g:10 mL.

[0020] Furthermore, the temperature of the enzymolysis is 35° C.-37° C., the time of the enzymolysis is 5 min-15 min, and the pH value of the enzymolysis is 7.20-7.50.

[0021] Furthermore, the complex enzyme is composed of cellulase and pectinase, the dosage of the complex enzyme is (1-3) g of the complex enzyme per 1 g of the mixture, and the weight ratio of the cellulase to the pectinase is 1:(3-6).

[0022] The traditional Chinese medicine composition for treating sleep apnea-hypopnea syndrome prepared by the above method has higher purity and better effect when combined with non-invasive ventilator treatment.

[0023] Application of the above-mentioned Chinese medicine composition in the preparation of medicine for treating sleep apnea-hypopnea syndrome.

[0024] A medicine for treating sleep apnea-hypopnea syndrome comprises the above-mentioned Chinese medicine composition and pharmaceutically acceptable auxiliary materials.

[0025] Beneficial effects:

[0026] The beneficial effects produced by the technical solution of the present invention are as follows:

[0027] The Chinese medicine composition of the present invention combines drugs with three effects of clearing away heat, promoting diuresis and clearing the orifices, and the drugs are used accurately and the compatibility is rigorous. By combining the Chinese medicine composition prepared by the prescription with conventional non-invasive ventilator treatment for the patient, the patient's AHI can be significantly reduced, the nighttime blood oxygen saturation can be improved, and the daytime sleepiness can be reduced. The therapeutic effect is significant and the symptoms of internal damp-heat, internal obstruction of phlegm and dampness, and obstruction of the orifices can be greatly improved. DETAILED DESCRIPTION

[0028] The principles and features of the present invention are described below. The examples given are only used to explain the present invention and are not used to limit the scope of the present invention.

[0029] Example 1

[0030] A traditional Chinese medicine composition for treating sleep apnea-hypopnea syndrome is prepared from the following traditional Chinese medicines in parts by weight: 15g of bamboo shavings, 10g of coptis root, 30g of reed stem, 15g of pinellia tuber, 15g of magnolia bark, 20g of tuckahoe, 10g of magnolia flower, 10g of xanthium sibiricum fruit and 10g of angelica dahurica.

[0031] The Chinese medicine composition of this embodiment is prepared by the following steps:

[0032] Mix bamboo shavings, coptis root and reed stem to obtain mixture 1, mix mixture 1 with water at a ratio of 1 g:10 mL, soak for 20 minutes, then boil, keep boiling for 20 minutes, filter and take the filtrate as decoction liquid;

[0033] Mix fennel, magnolia bark and poria to obtain mixture 2, mix mixture 2 with water at a ratio of 1 g:10 mL and soak for 20 minutes, then decoct and boil for 35 minutes, filter and take the filtrate, add anhydrous ethanol until the concentration of the ethanol solution is 55%, filter and remove impurities, take the filtrate to recover ethanol, and obtain extract 1, mix extract 1 with anhydrous ethanol until the concentration of the ethanol solution is 85%, filter and remove impurities, take the filtrate to recover ethanol, and obtain extract 2;

[0034] Mix magnolia flower, Xanthium sibiricum and Angelica dahurica to obtain mixture 3, mix mixture 3 with water and composite enzyme for enzymolysis for 10 minutes, take the enzymolysis solution and heat reflux extraction to obtain reflux extract 1, wherein the composite enzyme consists of cellulase and pectinase in a weight ratio of 1:5;

[0035] The decoction, extract 2 and reflux extract 1 are mixed, concentrated into an extract, dried and crushed to obtain the composition.

[0036] Example 2

[0037] A traditional Chinese medicine composition for treating sleep apnea-hypopnea syndrome is prepared from the following traditional Chinese medicines in parts by weight: 10 parts of bamboo shavings, 5 parts of coptis chinensis, 15 parts of reed stems, 9 parts of pinellia ternata, 10 parts of magnolia bark, 15 parts of tuckahoe, 5 parts of magnolia flower, 5 parts of xanthium sibiricum fruit and 5 parts of angelica dahurica.

[0038] The Chinese medicine composition of this embodiment is prepared by the following steps:

[0039] Mix bamboo shavings, coptis root and reed stem to obtain mixture 1, mix mixture 1 with water at a ratio of 0.8 g:10 mL, soak for 15 minutes, then boil, keep boiling for 15 minutes, filter and take the filtrate as decoction liquid;

[0040] Mix fennel, magnolia bark and poria to obtain mixture 2, mix mixture 2 with water at a ratio of 0.8 g:10 mL and soak for 15 minutes, then decoct and keep boiling for 30 minutes, filter and take the filtrate, add anhydrous ethanol until the concentration of the ethanol solution is 50%, filter and remove impurities, take the filtrate to recover ethanol, and obtain extract 1, mix extract 1 with anhydrous ethanol until the concentration of the ethanol solution is 80%, filter and remove impurities, take the filtrate to recover ethanol, and obtain extract 2;

[0041] Mix magnolia flower, Xanthium sibiricum and Angelica dahurica to obtain mixture 3, mix mixture 3 with water and composite enzyme for enzymolysis for 5 minutes, take the enzymolysis solution and heat reflux extraction to obtain reflux extract 1, wherein the composite enzyme consists of cellulase and pectinase in a weight ratio of 1:3;

[0042] The decoction, extract 2 and reflux extract 1 are mixed, concentrated into an extract, dried and crushed to obtain the composition.

[0043] Example 3

[0044] A traditional Chinese medicine composition for treating sleep apnea-hypopnea syndrome is prepared from the following traditional Chinese medicines in parts by weight: 20 parts of bamboo shavings, 15 parts of coptis chinensis, 45 parts of reed stems, 21 parts of pinellia ternata, 20 parts of magnolia bark, 25 parts of tuckahoe, 15 parts of magnolia flower, 15 parts of xanthium sibiricum fruit and 15 parts of angelica dahurica.

[0045] The Chinese medicine composition of this embodiment is prepared by the following steps:

[0046] Mix bamboo shavings, coptis root and reed stem to obtain mixture 1, mix mixture 1 with water at a ratio of 1.2 g:10 mL, soak for 30 min, then decoct, keep boiling for 25 min, filter and take the filtrate as decoction liquid;

[0047] Mix fennel, magnolia bark and poria to obtain mixture 2, mix mixture 2 with water at a ratio of 1.2 g:10 mL and soak for 30 minutes, then decoct and keep boiling for 40 minutes, filter and take the filtrate, add anhydrous ethanol until the concentration of the ethanol solution is 60%, filter and remove impurities, take the filtrate to recover ethanol, and obtain extract 1, mix extract 1 with anhydrous ethanol until the concentration of the ethanol solution is 90%, filter and remove impurities, take the filtrate to recover ethanol, and obtain extract 2;

[0048] Mix magnolia flower, Xanthium sibiricum and Angelica dahurica to obtain mixture 3, mix mixture 3 with water and composite enzyme for enzymolysis for 15 minutes, take the enzymolysis solution and heat reflux extraction to obtain reflux extract 1, wherein the composite enzyme consists of cellulase and pectinase in a weight ratio of 1:6;

[0049] The decoction, extract 2 and reflux extract 1 are mixed, concentrated into an extract, dried and crushed to obtain the composition.

[0050] Example 4

[0051] A traditional Chinese medicine composition for treating sleep apnea-hypopnea syndrome is prepared from the following traditional Chinese medicines in parts by weight: 12 parts of bamboo shavings, 7 parts of coptis chinensis, 20 parts of reed stems, 12 parts of pinellia ternata, 12 parts of magnolia bark, 17 parts of tuckahoe, 7 parts of magnolia flower, 8 parts of xanthium sibiricum fruit and 7 parts of angelica dahurica.

[0052] The preparation method of the Chinese medicine composition of this embodiment is the same as that of Example 1.

[0053] Example 5

[0054] A traditional Chinese medicine composition for treating sleep apnea-hypopnea syndrome is prepared from the following traditional Chinese medicines in parts by weight: 18 parts of bamboo shavings, 12 parts of coptis chinensis, 35 parts of reed stems, 18 parts of pinellia ternata, 18 parts of magnolia bark, 22 parts of tuckahoe, 12 parts of magnolia flower, 12 parts of xanthium sibiricum fruit and 12 parts of angelica dahurica.

[0055] The preparation method of the Chinese medicine composition of this embodiment is the same as that of Example 1.

[0056] Clinical studies on the Chinese medicine composition of the present invention for treating sleep apnea-hypopnea syndrome are as follows:

[0057] Research content

[0058] To investigate patients with sleep apnea-hypopnea syndrome and analyze their sleep apnea index (AHI), hypoxia degree and daytime sleepiness score (ESS) in order to benefit the clinical prevention and treatment of sleep apnea-hypopnea syndrome of damp-heat syndrome.

[0059] Study plan

[0060] 1. Research subjects

[0061] Case source: Hospitalized patients.

[0062] Patient population distribution: There were 43 male and 10 female patients for each treatment.

[0063] 2. Research Methods

[0064] Their AHI, hypoxia degree and ESS were collected and analyzed;

[0065] According to the diagnostic standards of TCM syndrome differentiation, refer to the diagnostic standards of "Expert Consensus on TCM Diagnosis and Treatment of Snoring" published in 2019.

[0066] Main symptoms: burning sensation in the nose, rough breath and phlegm in the throat, coughing up yellow and sticky phlegm, red face, shortness of breath, chest fullness or pain, dry mouth and thirst during the day, fever and irritability, bad breath, sweating, short and dark urine, dry and hard stool

[0067] Tongue and pulse: red tongue, greasy yellow fur

[0068] slippery pulse

[0069] The above main symptoms combined with tongue and pulse can be used for diagnosis.

[0070] (III) Observation indicators

[0071] Main efficacy indicators: AHI, hypoxia degree and ESS score.

[0072] (1) AHI (Sleep Apnea Index) is the average number of apnea and hypopnea occurrences per hour of sleep, and is one of the most objective data for measuring the severity of sleep apnea.

[0073] The AHI is used to classify the severity of sleep apnea according to the following criteria for adults:

[0074] Normal: Less than 5 times per hour of sleep

[0075] Mild: 5-14.9 events per hour of sleep

[0076] Moderate: 15-29.9 events per hour of sleep

[0077] Severe: 30 or more times per hour of sleep.

[0078] (2) The degree of hypoxia in patients can be divided into mild hypoxia, moderate hypoxia and severe hypoxia, which can be classified according to the patient's clinical symptoms and signs, arterial oxygen partial pressure, arterial oxygen saturation and oxygenation index. The normal oxygenation index is greater than 500 mmHg, so if it is lower than 500 mmHg, the patient will experience varying degrees of hypoxia.

[0079] 1. Mild hypoxia: The patient's arterial oxygen partial pressure is 80-60 mmHg, equivalent to 10.7-8.0 kPa, arterial oxygen saturation is usually <95%, but >80%, and the oxygenation index fluctuates between 200-300 mmHg, which is mild hypoxemia. Patients with mild hypoxia may have mild cyanosis of the lips and nail beds, with basically no disturbance of consciousness and obvious dyspnea, and may only show shortness of breath;

[0080] 2. Moderate hypoxia: The patient's arterial oxygen partial pressure is 60-40 mmHg, equivalent to 8.0-5.3 kPa, the arterial oxygen saturation is 60%-80%, and the oxygenation index is 100-200 mmHg, which is moderate hypoxemia. If the patient has moderate hypoxia, he may experience symptoms such as irritability, and obvious cyanosis of the lips and nail beds, but the patient has no impaired consciousness;

[0081] 3. Severe hypoxia: The patient's arterial oxygen partial pressure is less than 40 mmHg, equivalent to 5.3 kPa, arterial oxygen saturation is less than 60%, and oxygenation index is ≤100 mmHg, which is severe hypoxemia. The patient will have obvious disturbance of consciousness, drowsiness, coma, and cyanosis. Severe inspiratory dyspnea patients may be accompanied by the three-depression sign, that is, the clavicle, sternum, and ribs appear to sink.

[0082] (3) ESS score

[0083] The Sleep Disturbance Scale (ESS) is a standardized tool used to assess the degree of sleepiness. It contains 8 scenarios and asks participants to rate their tendency to sleepiness in different situations. The degree of each scenario is scored from 0 (no sleepiness) to 3 (high sleepiness). Participants answer questions based on their experiences in the past period of time, and the final score ranges from 0-24 points.

[0084] Based on the participants' scores in each scenario, their sleepiness level can be assessed. The higher the score, the more severe the sleepiness. Generally speaking, people with a score greater than 10 may have a sleepiness problem, and people with a score greater than 16 may have a severe sleepiness problem.

[0085] (IV) Data management and statistical analysis

[0086] SPSS19.0 statistical software was used for statistical analysis. The measurement data were expressed as mean ± standard deviation. The data of each group were first tested for homogeneity of variance. Under normal distribution conditions, one-way ANOVA was used to compare the means between the experimental groups; t test or paired t test (Students t test) was used to compare the groups. P < 0.05 was considered statistically significant.

[0087] Treatment method: On the first day, the patients first underwent polysomnography to evaluate AHI, nocturnal hypoxia and ESS scores; on the second day, non-invasive ventilator treatment was performed, and AHI, nocturnal hypoxia and ESS scores were evaluated after treatment; the patients in the control group continued to be treated with non-invasive ventilator from the third day to the tenth day, and AHI, nocturnal hypoxia and ESS scores were evaluated; the patients in the experimental group were treated with the Chinese medicine composition of Example 1 combined with non-invasive ventilator from the third day to the tenth day, and the Chinese medicine was taken twice a day, and AHI, nocturnal hypoxia and ESS scores were evaluated.

[0088] The results are shown in Table 1.

[0089] Table 1 Comparison of AHI, hypoxia degree and ESS in male and female patients before and after treatment

[0090]

[0091] Note: Compared with multi-channel monitoring, *P>0.05; compared with non-invasive ventilator treatment, & P<0.01; compared with the treatment of Chinese medicine combination combined with non-invasive ventilator, &P<0.01;

[0092] Research findings:

[0093] From Table 1, we can see that

[0094] Compared with treatment with non-invasive ventilator alone, treatment with a Chinese medicine composition combined with a non-invasive ventilator can reduce AHI, significantly improve the degree of nocturnal hypoxia, significantly improve the patient's daytime sleepiness ESS score, and improve the patient's symptoms.

[0095] It can be seen that the AHI of male and female patients was very high in polychannel monitoring, indicating that the patients had severe nasal or pharyngeal obstruction during sleep and severe sleep apnea. After non-invasive ventilator-assisted ventilation, the AHI dropped significantly compared with before, and the patients' sleep apnea was relieved. After treatment with the Chinese medicine composition, the AHI dropped significantly again compared with before, and the patients' sleep apnea was significantly relieved.

[0096] Multichannel monitoring showed that the blood oxygen saturation decreased significantly at night. After non-invasive ventilator-assisted ventilation, the patient's blood oxygen saturation increased significantly compared with before, indicating that the patient's hypoxia degree was relieved. After treatment with the Chinese medicine composition, the patient's blood oxygen saturation at night increased significantly again compared with before, indicating that the patient's hypoxia degree was milder.

[0097] Multichannel monitoring showed that the ESS was high, indicating that the patient had severe daytime sleepiness. After non-invasive ventilator-assisted ventilation, the patient's ESS was significantly lower than before, and the patient's daytime sleepiness was relieved. After treatment with the Chinese medicine composition, the patient's ESS was significantly lower than before, and the patient's daytime sleepiness was significantly relieved.

[0098] Clinical case analysis

[0099] The efficacy of the Chinese medicine composition of the present invention is further verified by using specific cases below.

[0100] Case 1: Zhang, male, 60 years old

[0101] Due to repeated nocturnal snoring for 5 years, aggravated for 1 week, repeated symptoms, seriously affecting daily life, the patient is 1.7 meters tall, weighs 80kg, BMI27.682, and polysomnography is performed in our hospital, AHI54.5, the lowest finger pulse oxygen at night is 61%, ESS22, indicating that the patient has severe obstructive sleep apnea hypopnea syndrome, severe nocturnal hypoxia, accompanied by severe daytime sleepiness, affecting daily life. After non-invasive ventilator treatment, AHI dropped to 14, the lowest finger pulse oxygen at night rose to 81%, and ESS dropped to 11, indicating that after non-invasive ventilator treatment, the patient's sleep apnea index is better than before, the degree of nocturnal hypoxia is improved than before, and the degree of daytime sleepiness is improved than before, with obvious improvement. After taking the Chinese medicine composition of Example 1, combined with non-invasive ventilator treatment for 1 week, the patient's AHI basically returned to normal, the degree of nocturnal hypoxia was better than before, ESS reached normal levels, and the patient's daytime symptoms were significantly improved than before, with obvious therapeutic effect.

[0102] Case 2: Fan, female, 68 years old

[0103] Due to repeated nocturnal snoring for 2 years, aggravated for 3 weeks, repeated symptoms, seriously affecting daily life, the patient was 1.51 meters tall, weighed 70kg, and had a BMI of 30.7. Polysomnography was performed in our hospital, with AHI of 79.5, the lowest finger pulse oxygen at night of 54%, and ESS of 20, indicating that the patient had severe obstructive sleep apnea hypopnea syndrome, severe nocturnal hypoxia, accompanied by severe daytime sleepiness, affecting daily life. After non-invasive ventilator treatment, AHI dropped to 16.5, the lowest finger pulse oxygen at night rose to 79%, and ESS dropped to 16, indicating that after non-invasive ventilator treatment, the patient's sleep apnea index was better than before, the degree of nocturnal hypoxia was improved than before, and the degree of daytime sleepiness was improved than before, with obvious improvement. After taking the Chinese medicine composition of Example 1 in the follow-up, and then combined with non-invasive ventilator treatment for 1 week, the patient's AHI basically returned to normal, the degree of nocturnal hypoxia was better than before, and ESS reached a normal level. The patient's daytime symptoms were significantly improved than before, with obvious therapeutic effect.

[0104] Case 3, Zhu, male, 55 years old

[0105] Due to repeated nocturnal snoring for 3 years, aggravated for 1 week, repeated symptoms, seriously affecting daily life, the patient was 1.68 meters tall, weighed 74kg, BMI26.22, and was monitored by polysomnography in our hospital, AHI44.6, the lowest finger pulse oxygen at night was 76%, ESS23, indicating that the patient had severe obstructive sleep apnea hypopnea syndrome, severe nocturnal hypoxia, accompanied by severe daytime sleepiness, affecting daily life. After non-invasive ventilator treatment, AHI dropped to 27, the lowest finger pulse oxygen at night rose to 89%, and ESS dropped to 12, indicating that after non-invasive ventilator treatment, the patient's sleep apnea index was better than before, the degree of nocturnal hypoxia was improved than before, and the degree of daytime sleepiness was improved than before, with obvious improvement. After taking the Chinese medicine composition of Example 1, combined with non-invasive ventilator treatment for 1 week, the patient's AHI basically returned to normal, the degree of nocturnal hypoxia was better than before, ESS reached normal levels, and the patient's daytime symptoms were significantly improved than before, with obvious therapeutic effect.

[0106] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A Chinese medicine composition for treating sleep apnea-hypopnea syndrome, characterized in that: The traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight: 10-20 parts of bamboo shavings, 5-15 parts of coptis root, 15-45 parts of reed stems, 9-21 parts of pinellia tuber, 10-20 parts of magnolia bark, 15-25 parts of tuckahoe, 5-15 parts of magnolia flower, 5-15 parts of xanthium sibiricum fruit and 5-15 parts of angelica dahurica.

2. A Chinese medicine composition for treating sleep apnea-hypopnea syndrome according to claim 1, characterized in that: The traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight: 12-18 parts of bamboo shavings, 7-12 parts of coptis root, 20-35 parts of reed stems, 12-18 parts of pinellia tuber, 12-18 parts of magnolia bark, 17-22 parts of tuckahoe, 7-12 parts of magnolia flower, 8-12 parts of xanthium sibiricum fruit and 7-12 parts of angelica dahurica.

3. A Chinese medicine composition for treating sleep apnea-hypopnea syndrome according to claim 1, characterized in that: The Chinese medicine composition is prepared from the following Chinese medicines in parts by weight: 15 parts of bamboo shavings, 10 parts of coptis root, 30 parts of reed stems, 15 parts of pinellia tuber, 15 parts of magnolia bark, 20 parts of tuckahoe, 10 parts of magnolia flower, 10 parts of xanthium sibiricum fruit and 10 parts of angelica dahurica.

4. A method for preparing the Chinese medicine composition according to any one of claims 1 to 3, characterized in that: The following steps are involved: (1) Mix bamboo shavings, coptis root and reed stem to obtain a mixture 1, mix the mixture 1 with water and soak it, then boil it, keep boiling for 15-25 minutes, filter and collect the filtrate as the decoction liquid; (2) Mixing fennel, magnolia bark and poria to obtain mixture 2, mixing mixture 2 with water and soaking, then boiling, keeping boiling for 30-40 minutes, filtering and collecting the filtrate, adding anhydrous ethanol to the filtrate until the concentration of the ethanol solution is 50-60%, filtering and removing impurities, collecting the filtrate to recover ethanol, obtaining filtrate extract 1, mixing the filtrate extract 1 with anhydrous ethanol until the concentration of the ethanol solution is 80-90%, filtering and removing impurities, collecting the filtrate to recover ethanol, and obtaining filtrate extract 2; (3) Mixing magnolia flower, Xanthium sibiricum fruit and Angelica dahurica to obtain mixture 3, mixing mixture 3 with water and complex enzyme for enzymolysis, and heating the enzymolysis solution for reflux extraction to obtain reflux extract 1; (4) The decoction, the filtrate extract 2 and the reflux extract 1 are mixed, concentrated into an extract, dried and ground to obtain the Chinese medicine composition.

5. The method for preparing a Chinese medicine composition for treating sleep apnea-hypopnea syndrome according to claim 4, characterized in that: In step (1) and step (2), the soaking time is 15 min-30 min.

6. The method for preparing a Chinese medicine composition for treating sleep apnea-hypopnea syndrome according to claim 4, characterized in that: The weight-to-volume ratio of the mixture 1 to water is (0.8-1.2) g:10 mL, and the weight-to-volume ratio of the mixture 2 to water is (0.8-1.2) g:10 mL.

7. The method for preparing a Chinese medicine composition for treating sleep apnea-hypopnea syndrome according to claim 4, characterized in that: The temperature of the enzymolysis is 35° C.-37° C., the time of the enzymolysis is 5 min-15 min, and the pH value of the enzymolysis is 7.20-7.

50.

8. The method for preparing a Chinese medicine composition for treating sleep apnea-hypopnea syndrome according to claim 4, characterized in that: The complex enzyme is composed of cellulase and pectinase, and the dosage of the complex enzyme is (1-3) g of the complex enzyme per 1 g of the mixture. The weight ratio of the cellulase to the pectinase is 1:(3-6).

9. Use of the Chinese medicine composition according to any one of claims 1 to 3 in the preparation of a medicament for treating sleep apnea-hypopnea syndrome.

10. A drug for treating sleep apnea hypopnea syndrome, characterized in that: The invention comprises the Chinese medicine composition according to any one of claims 1 to 3 and pharmaceutically acceptable excipients.

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