Traditional Chinese medicine composition for treating qi deficiency and blood stasis water retention type pulmonary heart disease as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention belongs to the technical field of pulmonary heart disease treatment medicines, and particularly relates to a traditional Chinese medicine composition for treating qi deficiency and blood stasis water retention type pulmonary heart disease as well as a preparation method and application thereof. The traditional Chinese medicine composition is prepared from radix astragali, radix salviae miltiorrhizae, radix paeoniae rubra, semen lepidii, cortex mori radicis and herba ephedrae. The traditional Chinese medicine composition can tonify qi and activate blood, release lung and relieve asthma, induce diuresis to alleviate edema, significantly improve oxyhemoglobin saturation and exercise tolerance, significantly reduce right ventricular systolic pressure and significantly inhibit right ventricular hypertrophy, so that the effect of treating the pulmonary heart disease is achieved by improving the cardiopulmonary function and pulmonary arterial hypertension; the traditional Chinese medicine composition can be used for preparing medicines for treating qi deficiency and blood stasis water retention type pulmonary heart disease, and can also be used for preparing medicines for improving oxyhemoglobin saturation and improving cardiopulmonary functions. Moreover, the traditional Chinese medicine composition is few in medicine flavor and low in clinical dosage, good medication compliance is easier to obtain, and the medication cost of a patient and the production cost for preparing a Chinese patent medicine by using the composition are reduced.

Description

Technical Field

[0001] The present invention belongs to the technical field of drugs for treating cor pulmonale, and particularly relates to a traditional Chinese medicine composition for cor pulmonale of qi deficiency, blood stasis and water retention type, and a preparation method and application thereof. Background Art

[0002] Cor pulmonale of qi deficiency, blood stasis and water retention type is a traditional Chinese medicine syndrome type of cor pulmonale, and its main symptoms are palpitations and shortness of breath, especially worse on exertion, and the concurrent symptoms are edema of the limbs or the whole body. Due to qi deficiency of the heart, there is shortness of breath and asthma, and qi deficiency makes it unable to endure fatigue, so it is even worse on exertion; qi promotes blood circulation, and qi deficiency is unable to promote blood circulation, so blood stasis is blocked internally, and the heart meridian loses nourishment, resulting in chest tightness and palpitations; when blood circulation is not smooth, it turns into water, and qi deficiency fails to promote transportation and transformation, eventually leading to internal retention of water dampness, overflowing to the limbs and skin, so there is edema of the limbs or the whole body. The tongue is pale and dull, the tongue coating is white, and the pulse is slippery, deep and slow, all of which are manifestations of qi deficiency, blood stasis and water retention. Compared with other syndrome types of cor pulmonale, cor pulmonale of qi deficiency, blood stasis and water retention type is based on qi deficiency, with equal emphasis on blood stasis and water retention, and the disease location involves the heart, lungs, spleen and kidneys.

[0003] The western medicine treatment of cor pulmonale of qi deficiency, blood stasis and water retention type is similar to that of other syndrome types of cor pulmonale. Commonly used drugs include diuretics, vasodilators, etc. However, long-term use may cause electrolyte disorders, liver and kidney damage, and the effect of treating both the symptoms and root causes of qi deficiency, blood stasis and water retention is limited. Summary of the Invention

[0004] In view of the above technical problems, the present invention provides a traditional Chinese medicine composition for cor pulmonale of qi deficiency, blood stasis and water retention type, and a preparation method and application thereof. This traditional Chinese medicine composition can replenish qi and activate blood circulation, relieve asthma by dispersing the lung qi, promote diuresis and alleviate edema, treat both the symptoms and root causes, and can effectively improve cardiopulmonary function and pulmonary artery hypertension.

[0005] To achieve the above invention purpose, the present invention adopts the following technical scheme: In the first aspect of the present invention, there is provided a traditional Chinese medicine composition for cor pulmonale of qi deficiency, blood stasis and water retention type, and the raw materials are proportioned by mass parts including 14 - 16 parts of Astragalus membranaceus, 14 - 16 parts of Salvia miltiorrhiza, 14 - 16 parts of Paeonia lactiflora, 14 - 16 parts of Lepidium apetalum, 11 - 13 parts of Morus alba root bark and 2.5 - 3.5 parts of Ephedra sinica.

[0006] This traditional Chinese medicine composition has the effects of replenishing qi and activating blood circulation, relieving asthma by dispersing the lung qi, promoting diuresis and alleviating edema, and can be used for treating cor pulmonale of qi deficiency, blood stasis and water retention type.

[0007] Astragalus membranaceus has a sweet taste and a slightly warm nature, and belongs to the spleen and lung meridians. It has the effects of invigorating the spleen and replenishing the middle, lifting yang and raising prolapse, benefiting qi and strengthening the exterior, promoting diuresis and alleviating edema, and expelling toxins and promoting granulation; Salvia miltiorrhiza has a bitter taste and a slightly cold nature, and belongs to the heart and liver meridians. It has the effects of promoting blood circulation to remove blood stasis, dredging meridians and relieving pain, clearing the heart and removing vexation, cooling blood and eliminating carbuncles; Paeonia lactiflora has a bitter taste and a slightly cold nature, and belongs to the liver meridian. It has the effects of clearing away liver fire, cooling blood, promoting blood circulation, and dispersing stasis and relieving pain; The taste of tianlizi is bitter and pungent, and it is cold in nature. It enters the lung and bladder meridians and has the effects of purging the lung and lowering qi, removing phlegm and relieving asthma, promoting diuresis and reducing swelling, and purging heat and expelling pathogens. Morus alba bark is sweet in taste and cold in nature. It enters the lung and spleen meridians and has the effects of purging the lungs and relieving asthma, promoting water circulation and reducing swelling. Ephedra tastes pungent and slightly bitter, is warm in nature, and enters the lung and bladder meridians. It can induce sweating, relieve exterior symptoms, clear the lungs and relieve asthma, and promote diuresis.

[0008] The basic pathogenesis of cor pulmonale is deficiency of the root and excess of the superficial symptoms. The root deficiency is mainly qi deficiency, while the superficial symptoms are mainly blood stasis and water retention. In this prescription, Astragalus membranaceus replenishes qi and nourishes the lungs, while Salvia miltiorrhiza activates blood circulation and removes blood stasis. The two herbs are used together as the main herbs, achieving the effect of replenishing qi and activating blood circulation; Red peony root removes blood stasis and relieves pain, while Lepidium tiliaceum promotes water circulation and reduces swelling. They are the assistant herbs, enhancing blood circulation and diuresis; Ephedra promotes lung function and relieves asthma, promotes diuresis and reduces swelling, while Morus alba purges the lung and relieves asthma, clears heat and resolves phlegm. They are the adjuvant herbs. The whole prescription has the effect of replenishing qi and activating blood circulation, promoting lung function and relieving asthma, promoting diuresis and reducing swelling, and can treat both the root and the superficial symptoms.

[0009] Experiments have shown that the Chinese medicine composition can significantly improve the blood oxygen saturation and exercise tolerance of mice with cor pulmonale, significantly reduce right ventricular systolic pressure, and significantly inhibit right ventricular hypertrophy. It can significantly improve the oxygen partial pressure, exercise tolerance and left ventricular ejection fraction and improve the cardiopulmonary function of patients with qi deficiency, blood stasis, and water retention type cor pulmonale. Therefore, the Chinese medicine composition can be used to treat qi deficiency, blood stasis, and water retention type cor pulmonale.

[0010] Preferably, the raw materials of the traditional Chinese medicine composition include 14.5-15.5 parts of astragalus, 14.5-15.5 parts of salvia miltiorrhiza, 14.5-15.5 parts of red peony root, 14.5-15.5 parts of leucophylla, 11.5-12.5 parts of mulberry bark and 2.5-3 parts of ephedra in proportion by mass.

[0011] Preferably, the raw materials of the traditional Chinese medicine composition include 15 parts of astragalus, 15 parts of salvia miltiorrhiza, 15 parts of red peony root, 15 parts of scutellaria baicalensis, 12 parts of mulberry bark and 3 parts of ephedra in proportion by mass.

[0012] The clinical dosage of the composition is small. In clinical application, the corresponding weight of each portion in each dose is 0.8-1.2 g.

[0013] The second aspect of the present invention provides a method for preparing the above-mentioned Chinese medicine composition, comprising: extracting the raw material with water. The obtained extract can be taken directly, or stored after concentration and drying, and taken with water before use, or the extract / dried product is prepared into a common preparation with a pharmaceutically acceptable excipient for use.

[0014] Preferably, the extraction method is reflux extraction.

[0015] Further preferably, the extraction is performed 2 to 3 times, the mass of the water in each extraction is 5 to 7 times the mass of the raw material, the extraction time is 1.5 to 2.5 hours, and the extracts obtained from each extraction are combined.

[0016] It is further preferably to extract twice, with the first extraction for 2.5 hours and the second extraction for 1.5 hours.

[0017] The third aspect of the present invention provides the use of the above traditional Chinese medicine composition or the traditional Chinese medicine composition prepared by the above preparation method, including: Use in the preparation of a drug for treating pulmonary heart disease of qi deficiency, blood stasis and water retention type; Use in the preparation of a drug for increasing blood oxygen saturation; Use in the preparation of a drug for improving cardiopulmonary function.

[0018] Preferably, the drug is an oral preparation, including but not limited to granules, capsules, tablets, powders, oral liquids, etc.

[0019] Preferably, the drug further includes a pharmaceutically acceptable excipient. After the above traditional Chinese medicine extract is extracted, it is made into a conventional oral preparation with the excipient to obtain the corresponding oral preparation.

[0020] The beneficial effects of the present invention are as follows: The traditional Chinese medicine composition provided by the present invention has the effects of supplementing qi and activating blood circulation, dispersing the lung and relieving asthma, promoting diuresis and reducing swelling, can increase blood oxygen saturation and exercise endurance, significantly reduce the right ventricular systolic pressure, and significantly inhibit right ventricular hypertrophy, thereby playing a role in treating pulmonary heart disease by improving cardiopulmonary function and pulmonary hypertension. Moreover, this traditional Chinese medicine composition has few medicinal flavors, a low clinical dosage, is more likely to obtain good medication compliance, and reduces the patient's medication cost and the production cost of the Chinese patent medicine prepared with this composition. Description of the Drawings

[0021] Figure 1 For the blood oxygen saturation of each group of mice in Example 11 ( n =8); Figure 2 For the exhaustion displacement of each group of mice in Example 11 ( n =6); Figure 3 For the exhaustion time of each group of mice in Example 11 ( n =6); Figure 4 For the right ventricular systolic pressure of each group of mice in Example 11 ( n =8); Figure 5 For the right ventricular hypertrophy index of each group of mice in Example 11 ( n =6).

[0022] Above Figures 1 to 5 Among them: ** indicates P<0.01 compared with the Control group; # indicates P<0.05 compared with the Hypoxia group, ##It indicates P < 0.01 when compared with the Hypoxia group; & indicates P < 0.05 when compared with the L-FXS group. Specific implementation manners

[0023] In order to make the objectives, technical solutions and advantages of the present invention more clear and understandable, the following further details the present invention in combination with specific embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not used to limit the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts fall within the protection scope of the present invention.

[0024] In the following examples, the astragalus membranaceus, salvia miltiorrhiza, radix paeoniae rubra, semen lepidii, cortex mori and ephedra all comply with the relevant regulations under each medicinal material item in Part I of the Chinese Pharmacopoeia (2020 Edition).

[0025] In the following examples, the raw materials, reagents, etc. used, unless otherwise specified, are all obtained through commercial channels.

[0026] Example 1 The embodiment of the present invention provides a traditional Chinese medicine composition for pulmonary heart disease of qi deficiency, blood stasis and water retention type. The raw materials per dose are 15 g of astragalus membranaceus, 15 g of salvia miltiorrhiza, 15 g of radix paeoniae rubra, 15 g of semen lepidii, 12 g of cortex mori and 3 g of ephedra.

[0027] The preparation method is as follows: Take the above-mentioned traditional Chinese medicine decoction pieces, first reflux extract with 6 times the amount of water for 2.5 hours, filter the extract, then reflux extract the medicinal residues with 6 times the amount of water for 1.5 hours, filter the extract, combine the filtrates, vacuum concentrate at 70 °C and then spray dry (the air outlet temperature is 60 - 70 °C) to obtain the product.

[0028] Example 2 The embodiment of the present invention provides a traditional Chinese medicine composition for pulmonary heart disease of qi deficiency, blood stasis and water retention type. The raw materials per dose are 14.5 g of astragalus membranaceus, 14.5 g of salvia miltiorrhiza, 14.5 g of radix paeoniae rubra, 14.5 g of semen lepidii, 11.5 g of cortex mori and 2.5 g of ephedra.

[0029] The preparation method is as follows: Take the above-mentioned traditional Chinese medicine decoction pieces, first reflux extract with 6 times the amount of water for 2.5 hours, filter the extract, then reflux extract the medicinal residues with 5 times the amount of water for 1.5 hours, filter the extract, combine the filtrates, vacuum concentrate at 70 °C and then spray dry (the air outlet temperature is 60 - 70 °C) to obtain the product.

[0030] Example 3 The embodiment of the present invention provides a traditional Chinese medicine composition for pulmonary heart disease of qi deficiency, blood stasis and water retention type. The raw materials per dose are 15.5 g of astragalus membranaceus, 15.5 g of salvia miltiorrhiza, 15.5 g of radix paeoniae rubra, 15.5 g of semen lepidii, 12.5 g of cortex mori and 3 g of ephedra.

[0031] The preparation method is as follows: Take the above-mentioned traditional Chinese medicine decoction pieces, first reflux extract with 6 times the amount of water for 2.5 hours, filter the extract, then reflux extract the medicinal residues with 5 times the amount of water for 1.5 hours, filter the extract, combine the filtrates, vacuum concentrate at 70 °C and then spray dry (the outlet temperature is 60 - 70 °C) to obtain the product.

[0032] Example 4 An embodiment of the present invention provides a traditional Chinese medicine composition for pulmonary heart disease of qi deficiency, blood stasis and water retention type. The raw materials per dose are 14 g of Astragalus membranaceus, 14 g of Salvia miltiorrhiza, 14 g of Paeonia lactiflora, 14 g of Lepidium apetalum, 11 g of Morus alba root bark and 2.5 g of Ephedra sinica.

[0033] The preparation method is as follows: Take the above-mentioned traditional Chinese medicine decoction pieces, first reflux extract with 7 times the amount of water for 2 hours, filter the extract, then reflux extract the medicinal residues with 5 times the amount of water for 1.5 hours, filter the extract, combine the filtrates, vacuum concentrate at 70 °C and then spray dry (the outlet temperature is 60 - 70 °C) to obtain the product.

[0034] Example 5 An embodiment of the present invention provides a traditional Chinese medicine composition for pulmonary heart disease of qi deficiency, blood stasis and water retention type. The raw materials per dose are 16 g of Astragalus membranaceus, 16 g of Salvia miltiorrhiza, 16 g of Paeonia lactiflora, 16 g of Lepidium apetalum, 13 g of Morus alba root bark and 3.5 g of Ephedra sinica.

[0035] The preparation method is as follows: Take the above-mentioned traditional Chinese medicine decoction pieces, first reflux extract with 7 times the amount of water for 2 hours, filter the extract, then reflux extract the medicinal residues with 5 times the amount of water for 1.5 hours, filter the extract, combine the filtrates, vacuum concentrate at 70 °C and then spray dry (the outlet temperature is 60 - 70 °C) to obtain the product.

[0036] Example 6 An embodiment of the present invention provides a traditional Chinese medicine granule for pulmonary heart disease of qi deficiency, blood stasis and water retention type. The preparation method is as follows: Mix the traditional Chinese medicine composition in any one of Examples 1 - 5 with lactose and dextrin, add purified water to prepare soft materials, granulate with a 16 - 18 mesh sieve, dry at 50 - 60 °C and then screen with an 18 - 20 mesh sieve, and then package to obtain the product.

[0037] Lactose and dextrin can be replaced with other pharmaceutically acceptable granule excipients. Flavoring agents and other excipients can also be added to the granule according to clinical needs.

[0038] Example 7 An embodiment of the present invention provides a traditional Chinese medicine hard capsule for pulmonary heart disease of qi deficiency, blood stasis and water retention type. The preparation method is as follows: Mix the traditional Chinese medicine composition in any one of Examples 1 - 5 with starch, microcrystalline cellulose and low-substituted hydroxypropyl cellulose, granulate in one step with 5% PVP aqueous solution, screen with a 22 - 24 mesh sieve, add 1% magnesium stearate, mix and then fill into hard capsule shells to obtain the product.

[0039] Starch and microcrystalline cellulose can be replaced with other pharmaceutically acceptable fillers, low-substituted hydroxypropyl cellulose can be replaced with other pharmaceutically acceptable disintegrants, and magnesium stearate can be replaced with other pharmaceutically acceptable glidants.

[0040] Example 8 An embodiment of the present invention provides a traditional Chinese medicine tablet for treating pulmonary heart disease with qi deficiency, blood stasis and water retention. The preparation method is as follows: Mix the traditional Chinese medicine composition in any one of Examples 1-5 with pregelatinized starch, microcrystalline cellulose and crospovidone, prepare a soft material with 8% starch paste as the binder, granulate through a 18-20 mesh sieve, dry at 50-60 °C and then screen through a 20-22 mesh sieve. Add 2% crospovidone, 1% magnesium stearate and 0.5% silicon dioxide, mix and then press into tablets to obtain the product.

[0041] Pregelatinized starch and microcrystalline cellulose can be replaced with other pharmaceutically acceptable fillers, crospovidone can be replaced with other pharmaceutically acceptable disintegrants, and magnesium stearate and silicon dioxide can be replaced with other pharmaceutically acceptable lubricants and glidants. The tablets can also be film-coated or sugar-coated according to clinical needs.

[0042] Example 9 An embodiment of the present invention provides a traditional Chinese medicine powder for treating pulmonary heart disease with qi deficiency, blood stasis and water retention. The preparation method is as follows: Dry the traditional Chinese medicine composition in any one of Examples 1-5 at 50-60 °C and then pulverize it, mix it with powdered sugar or aspartame and then sub-pack it to obtain the product.

[0043] Powdered sugar and aspartame can be replaced with other pharmaceutically acceptable flavoring agents.

[0044] Example 10 An embodiment of the present invention provides a traditional Chinese medicine oral liquid for treating pulmonary heart disease with qi deficiency, blood stasis and water retention. The preparation method is as follows: Dissolve the traditional Chinese medicine composition in any one of Examples 1-5 in water, add sucrose and sodium benzoate, and then fill it into containers to obtain the product.

[0045] Sucrose can be replaced with other pharmaceutically acceptable flavoring agents, and sodium benzoate can be replaced with other pharmaceutically acceptable preservatives.

[0046] Example 11 An embodiment of the present invention provides the effects of the traditional Chinese medicine composition obtained in Example 1 on the exercise endurance, blood oxygen saturation, right ventricular systolic pressure and right ventricular hypertrophy index of mice with pulmonary heart disease of qi deficiency, blood stasis and water retention type.

[0047] 1. Modeling method and grouping Eight-week-old male SPF C57BL / 6J mice were housed in a pathogen-free barrier system at a room temperature of 20 - 25°C, relative humidity of 40 - 60%, with a 12-hour light / dark cycle, and free access to food and water. The feed was Co60-irradiated sterilized maintenance feed (Spebefu (Beijing) Biotechnology Co., Ltd., SPF-F02-002). The above mice were divided into a normoxia group (Control group), a hypoxia group (Hypoxia group), a low-dose traditional Chinese medicine group (L-FXS group), a medium-dose traditional Chinese medicine group (Z-FXS group), a high-dose traditional Chinese medicine group (H-FXS group), and a sildenafil positive drug group (Sildenafil group), with 8 mice in each group. The mice in the normoxia group were fed under 21% O2 conditions, and the mice in the other groups were exposed to hypoxia (10% O2, 90% N2) for 6 weeks to establish a pulmonary heart disease mouse model.

[0048] Mice in each group were continuously gavaged once a day for 14 days at a volume of 0.2 mL per 10 g. The L-FXS group, Z-FXS group, L-FXS group, and H-FXS group were respectively given the aqueous solution of the traditional Chinese medicine composition in Example 1. The dosing dose of the L-FXS group was 6.5 g / kg / d (calculated by crude drug amount, equivalent dose), the dosing dose of the Z-FXS group was 13 g / kg / d (calculated by crude drug amount, 2-fold equivalent dose), the dosing dose of the H-FXS group was 19.5 g / kg / d (calculated by crude drug amount, 3-fold equivalent dose), the dosing dose of the Sildenafil group was 25 mg / kg, and the Control group and Hypoxia group were given an equal volume of normal saline.

[0049] 2. Detection indicators 2.1 Exercise exhaustion experiment Twenty-four hours after the last administration, the mice in each group were placed on a treadmill, with the speeds set at level 1, level 2, and level 3, a slope of 10°, and 100 shock times. After the running stopped, the data of exhaustion displacement were recorded. Before the formal experiment, each group of mice underwent treadmill training 3 times under the same conditions.

[0050] 2.2 Blood oxygen detection After the exercise exhaustion experiment, the mice in each group were anesthetized by intraperitoneal injection of 1% sodium pentobarbital (50 mg / Kg), and the blood oxygen concentration of the left front paw of the mice was detected using a blood oxygen detector, and the data were recorded after they were stable.

[0051] 2.3 Right ventricular systolic pressure The right ventricular systolic pressure of mice that had completed blood oxygen detection was measured using an open-chest method. An 18-gauge needle was connected to a polygraph through a pressure sensor, and the liquid path was connected with sodium heparin. Tracheal intubation was performed on the mice that had completed blood oxygen detection (still under anesthesia). The chest was incised under ventilator support to expose the right ventricle, and an 18-gauge needle connected to the pressure sensor at one end was inserted into the right ventricle. The right ventricular systolic pressure (RVSP) was recorded through the polygraph.

[0052] 2.4 Right ventricular hypertrophy index After hemodynamic detection, the mice were sacrificed. Ice-cold normal saline was infused into the inferior vena cava, and the heart was removed. The right ventricle and the left ventricle plus the interventricular septum were separated. The surface was blotted dry with filter paper and weighed on an analytical balance to calculate the right ventricular hypertrophy index, that is, the ratio of the right ventricle to the left ventricle + septum (RV / LV+S) value.

[0053] 3. Results The traditional Chinese medicine composition of Example 1 significantly increased the blood oxygen saturation ( Figure 1 ), and exercise endurance ( Figure 2 , Figure 3 ) of mice with cor pulmonale. Hemodynamic detection showed that this traditional Chinese medicine composition significantly reduced the right ventricular systolic pressure ( Figure 4 ) of mice with cor pulmonale; pathological analysis further showed that this traditional Chinese medicine composition could significantly inhibit right ventricular hypertrophy ( Figure 5 ) in mice with cor pulmonale. The above results confirmed that this traditional Chinese medicine composition could effectively improve the cardiopulmonary function and pulmonary artery hypertension of mice with cor pulmonale.

[0054] Example 12 This embodiment of the present invention provides a statistical analysis of the effects of the traditional Chinese medicine composition obtained in Example 1 in clinical applications.

[0055] Through retrospective case analysis, patients diagnosed with "chronic cor pulmonale" in the First Affiliated Hospital of Henan University of Chinese Medicine from June 2023 to December 2024 were collected. According to the inclusion criteria, 45 patients with cor pulmonale of qi deficiency and blood stasis, and internal retention of water-dampness type were screened out. Among them, 20 patients received conventional treatment (control group, symptomatic treatment with Western medicine according to the symptoms of the patients), and 25 patients received conventional treatment combined with the traditional Chinese medicine composition in Example 1 of the present invention (observation group, symptomatic treatment with Western medicine according to the symptoms of the patients, and at the same time, the traditional Chinese medicine composition of Example 1 of the present invention was given orally, one dose per day). The course of treatment for both groups was 4 - 6 weeks. There were no significant differences in baseline levels such as age and gender between the two groups of patients.

[0056] The statistical results are shown in Table 1. Compared with the control group, the partial pressure of oxygen (PaO2), six-minute walking distance (6MWD), and left ventricular ejection fraction (EF) of the observation group patients were significantly improved. These results indicate that the traditional Chinese medicine composition of Example 1 of the present invention can effectively improve the cardiopulmonary function of patients with pulmonary heart disease of qi deficiency and blood stasis, and internal retention of water-dampness type.

[0057] Table 1 Cardiopulmonary function of patients with pulmonary heart disease of qi deficiency and blood stasis, and internal retention of water-dampness type

[0058] Note: Compared with before treatment in this group, *, P < 0.05; compared with the control group at the same time, #, P < 0.05 The above are only the preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent substitutions, or improvements made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for pulmonary heart disease of qi deficiency, blood stasis and water retention type, characterized in that, The raw materials of the traditional Chinese medicine composition are proportioned by mass parts and include 14-16 parts of Astragalus membranaceus, 14-16 parts of Salvia miltiorrhiza, 14-16 parts of Paeonia lactiflora, 14-16 parts of Lepidium apetalum, 11-13 parts of Morus alba root bark, and 2.5-3.5 parts of Ephedra sinica.

2. The traditional Chinese medicine composition according to claim 1, wherein The raw materials of the traditional Chinese medicine composition are proportioned by mass parts and include 14.5-15.5 parts of Astragalus membranaceus, 14.5-15.5 parts of Salvia miltiorrhiza, 14.5-15.5 parts of Paeonia lactiflora, 14.5-15.5 parts of Lepidium apetalum, 11.5-12.5 parts of Morus alba root bark, and 2.5-3 parts of Ephedra sinica.

3. The traditional Chinese medicine composition according to claim 2, wherein, The raw materials of the traditional Chinese medicine composition are proportioned by mass parts and include 15 parts of Astragalus membranaceus, 15 parts of Salvia miltiorrhiza, 15 parts of Paeonia lactiflora, 15 parts of Lepidium apetalum, 12 parts of Morus alba root bark, and 3 parts of Ephedra sinica.

4. The preparation method of the traditional Chinese medicine composition according to any one of claims 1 to 3, characterized in that, Extract the said raw materials with water.

5. The preparation method according to claim 4, characterized in that, The extraction method is reflux extraction.

6. The preparation method according to claim 5, wherein Extract 2-3 times. Each time, the mass of the water is 5-7 times that of the raw materials, and the extraction time for each time is 1.5-2.5 hours. Combine the extraction liquids obtained each time.

7. The preparation method according to claim 6, characterized in that, Extract 2 times. The first extraction is for 2.5 hours, and the second extraction is for 1.5 hours.

8. Use of the traditional Chinese medicine composition according to any one of claims 1 to 3 or the traditional Chinese medicine composition prepared by the preparation method according to any one of claims 4 to 7, characterized in that, Include: Use in the preparation of drugs for treating pulmonary heart disease of qi deficiency, blood stasis and water retention type; Use in the preparation of drugs for increasing blood oxygen saturation; Use in the preparation of drugs for improving cardiopulmonary function.

9. The application according to claim 8, wherein The said drug is an oral preparation.

10. The application according to claim 8, wherein The said drug also includes a pharmaceutically acceptable excipient.

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