Traditional Chinese medicine composition for treating idiopathic pulmonary fibrosis and preparation method thereof

By adopting the traditional Chinese medicine composition based on the "monarch, minister, assistant, and envoy" compatibility theory, the existing treatment methods for idiopathic pulmonary fibrosis are solved, and the effects of significantly reducing the traditional Chinese medicine syndrome points, improving the efficacy of traditional Chinese medicine syndrome, improving the patient's Velcro rales and lung function are achieved, and it has good safety.

CN119857132APending Publication Date: 2025-04-22SHAANXI PROVINCIAL HOSPITAL OF CHINESE MEDICINE
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Patent Information

Application Number
CN202411891554.5
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2024-12-20
Publication Date
2025-04-22

AI Technical Summary

Technical Problem

The existing methods for treating idiopathic pulmonary fibrosis are poorly effective and have many adverse reactions. Traditional Chinese medicine treatment methods have problems such as drug dependence and uncertain efficacy.

Method used

A traditional Chinese medicine composition based on the "monarch, minister and assistant" compatibility theory, including Polygonatum, Astragalus, Cordyceps sinensis, Angelica sinensis, Amomum villossus, perilla seeds, chicken gizzard, Taibai rice, Clerose eggplant and licorice, is prepared by preparation methods such as drying, crushing, soaking, decocting and evaporation under reduced pressure, is used to prepare a traditional Chinese medicine composition for the treatment of idiopathic pulmonary fibrosis.

Benefits of technology

Significantly reduce the traditional Chinese medicine syndrome points, improve the efficacy of traditional Chinese medicine syndrome, and improve the patient's Velcro rales and lung function, with significant efficacy, reliable and good safety.

✦ Generated by Eureka AI based on patent content.

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Abstract

The invention discloses a traditional Chinese medicine composition for treating idiopathic pulmonary fibrosis and a preparation method thereof, and relates to the technical field of traditional Chinese medicine preparation. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 12 to 18 parts of rhizoma polygonati, 12 to 18 parts of radix astragali seu hedysari, 1 to 5 parts of cordyceps militaris powder, 6 to 10 parts of radix angelicae sinensis, 2 to 5 parts of fructus amomi, 6 to 12 parts of fructus perillae, 5 to 10 parts of endothelium corneum gigeriae galli, 6 to 12 parts of notholirion bulbuliferum, 6 to 10 parts of fructus litseae and 2 to 8 parts of liquorice root. The traditional Chinese medicine composition for treating idiopathic pulmonary fibrosis is remarkable and reliable in curative effect and good in safety.
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Description

Technical Field

[0001] The present invention relates to the technical field of Chinese medicine preparation, and in particular to a Chinese medicine composition for treating idiopathic pulmonary fibrosis and a preparation method thereof. Background Art

[0002] Idiopathic pulmonary fibrosis (IPF) is a chronic interstitial lung disease with unclear etiology and characterized by progressive dyspnea, which can eventually develop into respiratory failure and threaten the patient's life.

[0003] IPF is more common in middle-aged and elderly people. Its etiology and pathogenesis are not yet fully understood, and may be closely related to environmental, microbial and genetic factors. Currently, Western medicine often uses glucocorticoids, immunosuppressants and anti-fibrosis methods to treat the disease, but the efficacy is poor and there are many adverse reactions.

[0004] IPF is classified as "pulmonary emphysema" and "pulmonary paralysis" in traditional Chinese medicine. Ancient doctors believed that the pathogenesis of "pulmonary paralysis" was poor circulation of qi and blood, and obstruction of collateral vessels, while "pulmonary emphysema" was weak and sluggish lung qi, insufficient qi and blood, and insufficient collaterals. Most doctors believe that the pathogenesis of IPF is deficiency of the root and excess of the symptoms, with the disease mainly in the lungs and may affect the spleen and kidneys. Traditional Chinese medicine has the advantages of few adverse reactions and low drug dependence in the treatment of IPF. Based on this, it is urgent to develop a Chinese medicine combination drug with definite efficacy and high safety for the treatment of IPF. Summary of the invention

[0005] In view of the above problems, the present invention provides a Chinese medicine composition for treating idiopathic pulmonary fibrosis and a preparation method thereof.

[0006] In order to achieve the above object, the technical solution adopted by the present invention is as follows: One object of the present invention is to provide a traditional Chinese medicine composition for treating idiopathic pulmonary fibrosis. The raw material formula and weight proportions of the traditional Chinese medicine composition are: 12-18 parts of polygonatum, 12-18 parts of astragalus, 1-5 parts of cordyceps militaris powder, 6-10 parts of angelica, 2-5 parts of amomum, 6-12 parts of perilla seeds, 5-10 parts of chicken's gizzard lining, 6-12 parts of tamarind rice, 6-10 parts of eggplant, and 2-8 parts of liquorice.

[0007] Another object of the present invention is to provide a method for preparing the above-mentioned Chinese medicine composition for treating idiopathic pulmonary fibrosis, which specifically comprises the following steps: S1: Take polygonatum, astragalus, cordyceps militaris powder, angelica, amomum, perilla seed, chicken gizzard lining, tamarind, eggplant, and liquorice in parts by weight, rinse with clean water, dry, mix, crush and sieve to obtain a mixed drug powder for later use; S2: adding clean water to the drug mixture, soaking, boiling, and filtering; repeating the operation 3-5 times, and combining the filtrate after completion; evaporating and concentrating the filtrate under reduced pressure to obtain a drug extract; S3: Mixing the drug extract with pharmaceutically acceptable drug excipients to prepare the Chinese medicine composition.

[0008] Furthermore, in the step S1, the number of sieving is 100-120 meshes.

[0009] Furthermore, in step S2, the mass ratio of the mixed drug powder to clean water is 1:10-14; the soaking time is 0.5-1.5h, and the decoction time is 1.5-2.5h.

[0010] Furthermore, in step S2, the relative density of the drug extract is 1.25-1.35 g / mL.

[0011] Furthermore, in step S3, the mass ratio of the drug extract to the pharmaceutically acceptable drug excipient is 1:0.2-0.3.

[0012] Furthermore, in step S3, the dosage form of the Chinese medicine composition is tablets, pills, granules, capsules, powders or decoctions.

[0013] The Chinese medicine composition for treating idiopathic pulmonary fibrosis of the present invention is based on the theory of "monarch, minister, assistant and messenger" compatibility, with polygonatum, astragalus and cordyceps militaris powder as monarch medicines, which have the effects of invigorating qi and strengthening spleen, nourishing yin and invigorating lungs, etc.; with angelica, perilla seed, eggplant and Taibai rice as ministerial medicines, which have the effects of widening chest and regulating qi, removing phlegm and relieving cough, nourishing blood and activating blood circulation, etc.; with Amomum villosum and chicken's gizzard lining as adjuvant medicines, which have the effects of appetizing and invigorating spleen to achieve soil cultivation and gold production; with licorice as messenger medicine, which has the effects of invigorating spleen and qi and harmonizing medicinal properties. The pharmacological effects of each Chinese medicine raw material are as follows: Polygonatum: It is mild in nature, sweet in taste, and belongs to the lung meridian, spleen meridian, and kidney meridian. It has the effects of replenishing qi and nourishing yin, strengthening the spleen, moistening the lungs, and benefiting the kidneys. It is used to treat weak spleen and stomach, fatigue, dry mouth and poor appetite, lung deficiency and dry cough, lack of essence and blood, internal heat and thirst, etc.

[0014] Astragalus: sweet in taste, slightly warm in nature; it enters the spleen and lung meridians, has the effects of strengthening the spleen and replenishing the middle, raising yang and lifting the sunken, benefiting the defense and consolidating the exterior, promoting diuresis, and expelling toxins and promoting tissue regeneration. It is used to treat spleen qi deficiency syndrome, lung qi deficiency syndrome, qi deficiency and spontaneous sweating syndrome, qi and blood deficiency, sores that are difficult to heal, or sores that are difficult to heal for a long time.

[0015] Cordyceps militaris powder: sweet in taste, neutral in nature, enters the lung and kidney meridians, has the effects of nourishing the lungs and kidneys, relieving cough and reducing phlegm, and is used for long-term cough, weak asthma, and cough with blood in sputum due to fatigue.

[0016] Angelica: sweet and spicy in taste, warm in nature, enters the liver, heart and spleen meridians, has the effects of nourishing blood and activating blood circulation, regulating menstruation and relieving pain, and moistening the intestines and promoting bowel movements. It is used for blood deficiency and sallow complexion, dizziness and palpitations, irregular menstruation, amenorrhea and dysmenorrhea, abdominal pain due to deficiency and cold, rheumatic arthralgia, injuries from falls, carbuncles and ulcers, and dry intestine and constipation.

[0017] Amomum villosum: It tastes spicy and is warm in nature. It enters the spleen, stomach, and kidney meridians. It has the effects of removing dampness and stimulating the appetite, warming the spleen and stopping diarrhea, regulating qi and calming the fetus. It is used for dampness and turbidity blocking the middle part of the body, abdominal distension and lack of hunger, spleen and stomach deficiency and cold, vomiting and diarrhea, nausea during pregnancy, and fetal movement disorder.

[0018] Perilla seed: spicy in taste, warm in nature, enters the lung and large intestine meridians, has the effects of descending qi, eliminating phlegm, relieving asthma, and moistening the intestines. It is used for phlegm-blocked qi, cough and asthma, dry intestines and constipation.

[0019] Chicken's gizzard lining: sweet in taste, neutral in nature, enters the spleen, stomach, small intestine, and bladder meridians. It has the effects of strengthening the stomach and aiding food, astringing semen and stopping nocturnal emission, and clearing stranguria and dissolving stones. It is used for indigestion, vomiting and diarrhea, infantile malnutrition, enuresis, nocturnal emission, stones and pain in stranguria, and gallbladder distension and pain in the ribs.

[0020] Taibai rice: slightly warm in nature, pungent and bitter in taste, it enters the spleen meridian, lung meridian, stomach meridian, and large intestine meridian. It has the effects of relieving chest tightness and promoting qi, strengthening the stomach and stopping vomiting, relieving pain and expectorant, and relieving cough. It is mainly used to treat accumulation of symptoms, stomach pain and bloating, chest tightness, vomiting and nausea, wind-cold cough, and infantile convulsions.

[0021] Clear eggplant: warm in nature, pungent and slightly bitter in taste, it enters the stomach meridian, spleen meridian and kidney meridian, has the effects of warming the middle and relieving pain, promoting qi and blood circulation, relieving asthma and promoting diuresis, mainly used to treat cold pain in the abdomen, food accumulation and bloating, nausea and vomiting, vomiting and diarrhea due to heatstroke, diarrhea and dysentery, abdominal pain due to cold hernia, asthma, cold and damp water droplets, difficulty urinating, turbid urine, sores and swelling, toothache, cold and damp arthralgia, injuries from falls, etc.

[0022] Licorice: It is mild in nature, sweet in taste, and enters the heart meridian, stomach meridian, spleen meridian, and lung meridian. It has the effects of tonifying the spleen and replenishing qi, and harmonizing the properties of medicines.

[0023] Compared with the prior art, the present invention has the following beneficial effects: In the present invention, by adopting Chinese medicines with the effects of invigorating the spleen and moistening the lungs, promoting blood circulation and dispersing blood stasis as raw materials, a Chinese medicine composition for treating idiopathic pulmonary fibrosis is prepared according to the Chinese medicine compatibility theory of "monarch, minister, assistant and messenger", and the drug compatibility is reasonable; the Chinese medicine composition for treating idiopathic pulmonary fibrosis of the present invention has the effects of reducing the score of traditional Chinese medicine symptoms, improving the efficacy of traditional Chinese medicine symptoms, and improving the Velcro rales and lung function of patients, and has significant and reliable efficacy and good safety. DETAILED DESCRIPTION

[0024] In order to make the purpose and advantages of the present invention more clearly understood, the present invention is further described in detail below in conjunction with the 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.

[0025] The instruments, reagents, materials, etc. involved in the following examples, unless otherwise specified, are all conventional instruments, reagents, materials, etc. in the prior art and can be obtained through regular commercial channels. The experimental methods, detection methods, etc. involved in the following examples, unless otherwise specified, are all conventional experimental methods, detection methods, etc. in the prior art.

[0026] Example 1 The present embodiment provides a Chinese medicine composition for treating idiopathic pulmonary fibrosis, wherein the raw material formula and weight proportions thereof are: 12 parts of polygonatum, 12 parts of astragalus, 1 part of cordyceps militaris powder, 6 parts of angelica, 2 parts of amomum, 6 parts of perilla seeds, 5 parts of chicken gizzard lining, 6 parts of tamarind rice, 6 parts of eggplant, and 2 parts of liquorice.

[0027] This embodiment also provides a method for preparing the above-mentioned Chinese medicine composition for treating idiopathic pulmonary fibrosis, which specifically comprises the following steps: S1: Take polygonatum, astragalus, cordyceps militaris powder, angelica, amomum, perilla seed, chicken gizzard lining, rice, eggplant, and liquorice according to weight, rinse with clean water, dry, mix, crush, and pass through a 100-mesh sieve to obtain a mixed drug powder for later use; S2: Add 10 times the mass of clean water to the drug mixture, soak for 0.5h, decoct for 1.5h, and filter; repeat the operation 3 times, and combine the filtrate after completion; evaporate and concentrate the filtrate under reduced pressure to obtain a drug extract with a relative density of 1.25g / mL; S3: Mixing the drug extract with pharmaceutically acceptable drug excipients in a mass ratio of 1:0.2 to prepare a Chinese medicine composition in the form of tablets.

[0028] Example 2 The present embodiment provides a Chinese medicine composition for treating idiopathic pulmonary fibrosis, wherein the raw material formula and weight proportions thereof are: 15 parts of polygonatum, 15 parts of astragalus, 3 parts of cordyceps militaris powder, 8 parts of angelica, 3 parts of amomum, 9 parts of perilla seeds, 8 parts of chicken gizzard lining, 9 parts of tamarind rice, 8 parts of eggplant, and 5 parts of liquorice.

[0029] This embodiment also provides a method for preparing the above-mentioned Chinese medicine composition for treating idiopathic pulmonary fibrosis, which specifically comprises the following steps: S1: Take polygonatum, astragalus, cordyceps militaris powder, angelica, amomum, perilla seed, chicken gizzard lining, rice, eggplant, and liquorice according to weight, rinse with clean water, dry, mix, crush, and pass through a 110-mesh sieve to obtain a mixed drug powder for later use; S2: Add 12 times the weight of clean water to the drug mixture, soak for 1 hour, decoct for 2 hours, and filter; repeat the operation 4 times, and combine the filtrate after completion; evaporate and concentrate the filtrate under reduced pressure to obtain a drug extract with a relative density of 1.30 g / mL; S3: Mix the drug extract with pharmaceutically acceptable drug excipients in a mass ratio of 1:0.25 to prepare a Chinese medicine composition in the form of pills.

[0030] Example 3 The present embodiment provides a Chinese medicine composition for treating idiopathic pulmonary fibrosis, wherein the raw material formula and weight proportions thereof are: 18 parts of polygonatum, 18 parts of astragalus, 5 parts of cordyceps militaris powder, 10 parts of angelica, 5 parts of amomum, 12 parts of perilla seeds, 10 parts of chicken gizzard lining, 12 parts of tamarind rice, 10 parts of eggplant, and 8 parts of liquorice.

[0031] This embodiment also provides a method for preparing the above-mentioned Chinese medicine composition for treating idiopathic pulmonary fibrosis, which specifically comprises the following steps: S1: Take polygonatum, astragalus, cordyceps militaris powder, angelica, amomum, perilla seed, chicken gizzard lining, tamarind, eggplant, and liquorice in parts by weight, rinse with clean water, dry, mix, crush, and pass through a 120-mesh sieve to obtain a mixed drug powder for later use; S2: Add 14 times the mass of clean water to the drug mixture, soak for 1.5 hours, decoct for 2.5 hours, and filter; repeat the operation 5 times, and combine the filtrate after completion; evaporate and concentrate the filtrate under reduced pressure to obtain a drug extract with a relative density of 1.35 g / mL; S3: Mix the drug extract with pharmaceutically acceptable drug excipients in a mass ratio of 1:0.3 to prepare a granular Chinese medicine composition.

[0032] Example 4 The difference from Example 2 is that the prepared Chinese medicine composition is a capsule.

[0033] Example 5 The difference from Example 2 is that the prepared Chinese medicine composition is a powder.

[0034] Example 6 The difference from Example 2 is that the prepared Chinese medicine composition is a decoction.

[0035] A clinical trial was conducted using the Chinese medicine composition for treating idiopathic pulmonary fibrosis of this embodiment. The following is the specific process and results of the clinical trial: 1. Diagnostic criteria: (1) Western medicine diagnostic criteria: refer to the latest international IPF diagnostic guidelines in 2018. ① Excluding other known causes of interstitial lung disease (such as family environment, occupational environmental exposure, connective tissue disease, etc.), plus item 2 or 3; ② High-resolution computed tomography (HRCT) shows usual interstitial pneumonia (UIP) type; ③ HRCT typing and lung biopsy histopathological typing meet specific combinations. (2) Traditional Chinese medicine diagnostic criteria: Syndrome diagnostic criteria for IPF with spleen deficiency and blood stasis. Refer to the "Traditional Chinese Medicine Clinical Pathway for Pulmonary Fibrosis (2017 Edition)" in the "Traditional Chinese Medicine Diagnosis and Treatment Plan for 24 Specialties and 92 Diseases" formulated by the State Administration of Traditional Chinese Medicine and the "Guidelines for Clinical Research of New Chinese Medicines" (2002): Main symptoms: wheezing, chest tightness, shortness of breath, aggravated by movement, dry cough with little or no sputum. Secondary symptoms: thirst, dark complexion, cyanotic lips, dark purple tongue or ecchymosis, white or yellow fur, stringy and slippery pulse or stringy and astringent pulse. The diagnosis can be made if the main symptom and two or more secondary symptoms are present, combined with the tongue and pulse.

[0036] 2. Inclusion criteria: ① Meet the Western medical diagnostic criteria for IPF; ② Meet the Chinese medical diagnostic criteria for spleen deficiency and blood stasis; ③ Disease severity is mild to moderate; ④ Age 49-85 years old, regardless of gender; ⑤ Voluntary and signed informed consent.

[0037] 3. Exclusion criteria: ① Patients in acute exacerbation or late critical condition; ② Patients with other primary lung diseases (such as bronchial asthma, chronic obstructive pulmonary disease, lung cancer); ③ Patients with serious primary diseases such as cardiovascular, renal, and liver diseases; ④ Patients with mental illness; ⑤ Patients with acute symptoms such as bleeding and fever; ⑥ Pregnant or lactating women; ⑦ Patients with known allergies to the components of the trial drugs; ⑧ Patients who have participated in other clinical studies in the past 3 months; ⑨ Patients who are unwilling to receive trial treatment.

[0038] 4. Experimental subjects: According to the inclusion and exclusion criteria, 145 eligible cases were screened from IPF patients who visited Shaanxi Provincial Hospital of Traditional Chinese Medicine from 2015 to 2022. According to the principle of open and parallel control, the patients were randomly divided into two groups: 73 cases in the treatment group and 72 cases in the control group. There was no statistical difference in the clinical data such as age, gender, condition, symptoms, etc. between the two groups of experimental subjects, and they were comparable.

[0039] 5. Treatment (intervention) methods: (1) Control group: Pirfenidone capsules (Aisiri, Beijing Contini Pharmaceutical Co., Ltd.) were administered, 200 mg each time, 3 times a day, half an hour after meals.

[0040] (2) Treatment group: The patients were given the Chinese medicine composition for treating idiopathic pulmonary fibrosis pills of Example 2, 20 g per day, divided into 3 doses, taken orally half an hour after meals.

[0041] The two groups of patients were given intervention treatment according to the above method, with a treatment course of 2 months.

[0042] 6. Indicator monitoring (1) TCM syndrome score: The score standard was formulated with reference to the "Clinical Guidance for New Chinese Medicines" (2002 edition). Main symptoms: wheezing, chest tightness, shortness of breath, aggravated by movement, dry cough with little or no sputum. Secondary symptoms: thirst, dull complexion, cyanotic lips, dark purple tongue or ecchymosis, white or yellow tongue coating, stringy or astringent pulse. The score standard for each main symptom is: 0 point for none, 2 points for mild, 4 points for moderate, and 6 points for severe; the score standard for each secondary symptom is: 0 point for none, 1 point for mild, 2 points for moderate, and 3 points for severe. Record once before and after treatment.

[0043] (2) TCM syndrome efficacy: This was formulated based on the "Guidelines for the Diagnosis and Treatment of Idiopathic Pulmonary (Interstitial) Fibrosis (Draft)" formulated by the Respiratory Branch of the Chinese Medical Association in 2002. The symptom score was determined using the nimodipine score method, i.e. (pre-treatment score - post-treatment score) / pre-treatment score × 100%. Cured: clinical symptoms and signs disappeared or basically disappeared, and the TCM syndrome score decreased by ≥90%; markedly effective: clinical symptoms and signs significantly improved, and the TCM syndrome score decreased by ≥70%; effective: clinical symptoms and signs improved, and the TCM syndrome score decreased by 30%-70%; ineffective: clinical symptoms and signs did not improve significantly, or even worsened, and the TCM syndrome score decreased by less than 30%.

[0044] (3) Main symptom score: Velcro rales: evaluated once before and after treatment, as follows: severe (6 points): rales are heard all over both lungs; moderate (4 points): rales are scattered in both lungs; mild (2 points): rales can be heard in one lung; none (0 points): rales cannot be heard in both lungs.

[0045] (4) Pulmonary function test: Use a spirometry instrument to measure forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), and diffusion capacity (DLco); perform arterial blood gas analysis; and record partial pressure of oxygen (PaO2).

[0046] (5) Safety examination: Perform blood routine, urine routine, liver function, kidney function, blood sugar and electrocardiogram examinations once before and after treatment. Closely observe and record the patient's response to treatment at any time. If adverse reactions occur, take relevant treatment measures immediately and record them.

[0047] 7. Statistical analysis The experimental data were analyzed and processed using SPSS 22.0 software and expressed as mean ± standard deviation. The measurement data were analyzed using t test and the count data were analyzed using X-test. 2 Inspection and rank data were analyzed using Ridit.

[0048] 8. Results (1) Comparison of TCM syndrome scores The results of the comparison of TCM syndrome scores of patients before and after treatment are shown in Table 1. As can be seen from Table 1, the TCM syndrome scores of the treatment group after treatment were significantly lower than those before treatment, and at the same time, the TCM syndrome scores of the treatment group after treatment were significantly lower than those of the control group. This indicates that the Chinese medicine composition for treating idiopathic pulmonary fibrosis in this embodiment has the effect of reducing TCM syndrome scores.

[0049] Table 1 Comparison of TCM syndrome scores

[0050] Note: * For comparison with before treatment, P < 0.05; # Compared with the control group, P<0.05.

[0051] (2) Comparison of TCM syndrome efficacy The results of the comparison of the TCM syndrome efficacy of the patients before and after treatment are shown in Table 2. As shown in Table 2, the total effective rate of the treatment group was 90.41%, and the total effective rate of the control group was 84.72%. This shows that the TCM syndrome efficacy of the Chinese medicine composition for treating idiopathic pulmonary fibrosis in this embodiment is better than that of the control group.

[0052] Table 2 Comparison of efficacy of TCM syndromes

[0053] (3) Comparison of Velcro rales scores The results of the comparison of the Velcro rales scores of the patients before and after treatment are shown in Table 3. As can be seen from Table 3, the Velcro rales scores of the treatment group and the control group after treatment were significantly lower than those before treatment, and at the same time, the Velcro rales scores of the treatment group after treatment were significantly lower than those of the control group. This shows that the Chinese medicine composition for treating idiopathic pulmonary fibrosis in this embodiment has the effect of improving the Velcro rales of patients.

[0054] Table 3 Comparison of Velcro rales scores

[0055] Note: * For comparison with before treatment, P < 0.05; # Compared with the control group, P<0.05.

[0056] (4) Comparison of lung function The comparison results of the lung function test of patients before and after treatment are shown in Table 4. As can be seen from Table 4, the FEV1 / FVC of the treatment group and the control group after treatment was significantly lower than that before treatment, and the DLco and PaO2 after treatment were significantly higher than those before treatment; in addition, there were significant differences in FEV1 / FVC, DLco, and PaO2 between the treatment group and the control group after treatment. This shows that the Chinese medicine composition for treating idiopathic pulmonary fibrosis in this embodiment has the effect of improving lung function.

[0057] Table 4 Comparison of lung function

[0058] Note: * For comparison with before treatment, P < 0.05; # Compared with the control group, P<0.05.

[0059] (5) Safety evaluation Both groups underwent routine blood tests, routine urine tests, liver function tests, kidney function tests, blood sugar tests and electrocardiogram tests before and after treatment, and the results were all within the normal range. The patients' vital signs were stable, and no adverse reactions occurred, indicating that the Chinese medicine composition for treating idiopathic pulmonary fibrosis of this embodiment has good safety.

[0060] In some embodiments of the present invention, clinical trials were conducted using the Chinese medicine compositions for treating idiopathic pulmonary fibrosis of Example 1 and Examples 3-6, and the same experimental results as those of the Chinese medicine composition of Example 2 were obtained (having the efficacy of reducing the TCM syndrome score, improving the TCM syndrome efficacy, improving the patient's Velcro rales, and improving lung function).

[0061] Based on the above results, it can be seen that the Chinese medicine composition for treating idiopathic pulmonary fibrosis of Examples 1-6 has the effects of reducing TCM syndrome scores, improving TCM syndrome efficacy, and improving patients' Velcro rales and lung function, and has significant and reliable efficacy and good safety.

[0062] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. A Chinese medicine composition for treating idiopathic pulmonary fibrosis, characterized in that: The raw material formula and weight proportions of the Chinese medicine composition are: 12-18 parts of polygonatum, 12-18 parts of astragalus, 1-5 parts of cordyceps militaris powder, 6-10 parts of angelica, 2-5 parts of amomum, 6-12 parts of perilla seeds, 5-10 parts of chicken gizzard lining, 6-12 parts of tamarind rice, 6-10 parts of eggplant, and 2-8 parts of liquorice.

2. A method for preparing a Chinese medicine composition for treating idiopathic pulmonary fibrosis as claimed in claim 1, characterized in that: The specific steps include: S1: Take polygonatum, astragalus, cordyceps militaris powder, angelica, amomum, perilla seed, chicken gizzard lining, tamarind, eggplant, and liquorice in parts by weight, rinse with clean water, dry, mix, crush and sieve to obtain a mixed drug powder for later use; S2: adding clean water to the drug mixed powder, soaking, decocting, and filtering; repeating the operation 3-5 times, and combining the filtrate after completion; evaporating and concentrating the filtrate under reduced pressure to obtain a drug extract; S3: Mixing the drug extract with pharmaceutically acceptable drug excipients to prepare the Chinese medicine composition.

3. A method for preparing a Chinese medicine composition for treating idiopathic pulmonary fibrosis according to claim 2, characterized in that: In the step S1, the number of sieving is 100-120 meshes.

4. A method for preparing a Chinese medicine composition for treating idiopathic pulmonary fibrosis according to claim 2, characterized in that: In step S2, the mass ratio of the mixed drug powder to clean water is 1:10-14; the soaking time is 0.5-1.5 hours, and the decoction time is 1.5-2.5 hours.

5. A method for preparing a Chinese medicine composition for treating idiopathic pulmonary fibrosis according to claim 2, characterized in that: In step S2, the relative density of the drug extract is 1.25-1.35 g / mL.

6. A method for preparing a Chinese medicine composition for treating idiopathic pulmonary fibrosis according to claim 2, characterized in that: In the step S3, the mass ratio of the drug extract to the pharmaceutically acceptable drug excipient is 1:0.2-0.

3.

7. A method for preparing a Chinese medicine composition for treating idiopathic pulmonary fibrosis according to claim 2, characterized in that: In step S3, the dosage form of the Chinese medicine composition is tablets, pills, granules, capsules, powders or decoctions.