Traditional Chinese medicine composition for treating primary sicca syndrome complicated with interstitial lung disease and application thereof

Abstract

The invention provides a traditional Chinese medicine composition for treating primary sicca syndrome complicated with interstitial lung disease and application of the traditional Chinese medicine composition, and relates to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials in parts by weight: 10-15g of radix glehniae, 10-15g of radix ophiopogonis, 15-30g of radix pseudostellariae, 10-20g of curcuma zedoary, 6-12g of roasted stiff silkworm and 15-30g of wild buckwheat rhizome. The traditional Chinese medicine composition can safely and effectively improve the respiratory function, dry mouth, dry eye and other symptoms of pSS-ILD patients, improve the life quality of the patients and delay the disease progression, has no obvious side effect, and is simple in formula and low in cost.

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 primary Sjögren's syndrome combined with interstitial lung disease and an application thereof. Background Art

[0002] Primary Sjögren's syndrome PSS is a chronic inflammatory autoimmune disease that mainly affects exocrine glands. It is characterized by lymphocyte infiltration of salivary glands and lacrimal glands. Its prevalence is as high as 11.4%. It is one of the most common multi-system autoimmune diseases. Its main clinical manifestations are keratoconjunctivitis sicca and dry mouth. It can also affect multiple systems and organs in the body. In terms of the respiratory system, interstitial lung disease (ILD) is the most common complication of pSS, with interstitial lung inflammation and fibrosis as the main manifestations. Among pSS patients, the global average prevalence of ILD is 13%, and it is as high as 20% in Asian populations. There are many clinical symptoms, mainly dyspnea and cough, which seriously hinder the work and life of patients. At the same time, life-threatening complications such as respiratory failure and pulmonary hypertension may also occur, and the mortality rate is significantly higher than that of patients without lung involvement. At present, there is no specific treatment for pSS-ILD (primary Sjögren's syndrome with interstitial lung disease) in clinical practice. When the disease is in the inflammatory stage, it is usually treated with glucocorticoids combined with immunosuppressants, but this therapy is not suitable for patients with chronic disease course, extensive fibrosis, or no ground-glass opacity in HRCT, and contraindications to hormones. For ILD that has entered the pulmonary fibrosis stage, commonly used therapeutic drugs include anti-fibrotic drugs such as pirfenidone and nintedanib. However, due to its limited efficacy, high cost, and possible side effects of varying degrees. Traditional Chinese medicine provides a treatment option for pSS-ILD that can improve the condition, has no obvious side effects, and focuses on adjusting overall function. It is especially suitable for patients who are contraindicated or intolerant to hormone, immunosuppressant and anti-fibrotic drug treatment. Existing traditional Chinese medicine compound preparations are complicated to prepare because the formula contains multiple medicinal materials, which increases the economic burden and medication risks. Summary of the invention

[0003] The present invention aims to provide a Chinese medicine composition for treating primary Sjögren's syndrome combined with interstitial lung disease, which can safely and effectively improve the respiratory function and symptoms such as dry mouth and dry eyes of pSS-ILD patients, improve the quality of life of patients, delay the progression of the disease, have no obvious side effects, and have a simple formula and low cost.

[0004] The purpose of the present invention is achieved by the following technical solutions:

[0005] A traditional Chinese medicine composition for treating primary Sjögren's syndrome combined with interstitial lung disease is prepared from the following traditional Chinese medicine raw materials in parts by weight: 10-15g of Glehnia littoralis, 10-15g of Radix Ophiopogonis, 15-30g of Radix Pseudostellariae, 10-20g of Curcuma zedoariae, 6-12g of roasted Bombyx batryticatus, and 15-30g of Fagopyrum scabra.

[0006] The preferred technical solution is that the Chinese medicine composition is made of the following Chinese medicine raw materials in parts by weight: 12g of Glehnia littoralis, 10g of Ophiopogon japonicus, 25g of Pseudostellaria baicalensis, 20g of Curcuma zedoaria, 10g of roasted Bombyx batryticatus, and 25g of Fagopyrum scabra.

[0007] The present invention also provides a method for preparing the Chinese medicine composition, comprising the following steps: weighing each Chinese medicine raw material, adding water and decocting for 2-5 times, taking the decoctions and combining them to obtain the Chinese medicine composition.

[0008] In the present invention, the decoction and a pharmaceutically acceptable carrier are made into tablets, capsules, pills, granules and oral liquids.

[0009] In the present invention, the decoction is concentrated under reduced pressure at 55-65° C. and then made into tablets, capsules, pills, granules and oral liquid.

[0010] The present invention also provides application of the traditional Chinese medicine composition in preparing a medicine for treating primary Sjögren's syndrome combined with interstitial lung disease.

[0011] Beneficial effects: The Chinese medicine composition for treating pSS-ILD of the present invention has a concise and scientific formula, has the effects of invigorating qi and nourishing yin, moistening the lungs and dredging collaterals, has a definite curative effect in treating pSS-ILD, can safely and effectively improve the respiratory function and symptoms such as dry mouth and dry eyes of pSS-ILD patients, improve the quality of life of patients, delay the progression of the disease, has no obvious side effects, and is low in cost. The Chinese medicine composition of the present invention reduces the types of medicinal materials, simplifies the preparation process, reduces costs, and maintains the efficacy at the same time. DETAILED DESCRIPTION

[0012] Example 1 Chinese medicine composition for treating primary Sjögren's syndrome combined with interstitial lung disease

[0013] The preparation method of the Chinese medicine composition for treating primary Sjögren's syndrome combined with interstitial lung disease is as follows: weigh the following Chinese medicine raw materials: 12g of Northern Adenophora, 10g of Ophiopogon japonicus, 25g of Pseudostellaria baicalensis, 20g of Curcuma zedoaria, 10g of roasted Bombyx batryticatus, and 25g of Fagopyrum scabra, add water and boil twice, adding 800ml of water each time, taking the two decoctions and mixing them evenly, a total of 300ml, to obtain a daily dose of the Chinese medicine composition of the present invention, divided into two portions, and taken orally in the morning and evening.

[0014] The preparation method of the control Chinese medicine composition for treating primary Sjögren's syndrome combined with interstitial lung disease is as follows: weigh the following Chinese medicinal raw materials: 12g of Northern Adenophora, 10g of Ophiopogon japonicus, 25g of Pseudostellaria heterophylla, 12g of Adenophora australis, 12g of Persica juncea, 20g of Curcuma zedoaria, 10g of roasted Bombyx batryticatus, 15g of goat's milk, 25g of Fagopyrum serrata, and 3g of raw licorice, add water and boil twice, adding 800ml of water each time, take the two decoctions and mix them evenly, a total of 300ml, to obtain a daily dose of the control Chinese medicine composition, divide it into two portions, and take one portion orally in the morning and evening.

[0015] Example 2

[0016] The Chinese medicine composition prepared in Example 1 was used to treat a number of pSS-ILD patients, and the treatment conditions of 82 patients were statistically analyzed.

[0017] 1. General Information

[0018] The cases in this study were from inpatients and outpatients with primary Sjögren's syndrome and interstitial lung disease in Jiangsu Provincial Hospital of Traditional Chinese Medicine. A total of 82 pSS-ILD patients were included in this study and randomly divided into three groups: 28 in the Western medicine control group, 26 in the Chinese medicine control group, and 28 in the treatment group.

[0019] 1.1 Inclusion criteria

[0020] 1) Age 18-75 years old;

[0021] 2) primary Sjögren's syndrome meets the 2016 American College of Rheumatology / European League Against Rheumatism classification criteria for primary Sjögren's syndrome;

[0022] Table 1 2016 American College of Rheumatology / European League Against Rheumatism scoring method for primary Sjögren's syndrome

[0023]

[0024] Inclusion criteria: patients with at least one symptom of dry eyes or dry mouth, that is, at least one of the following is positive: ① unbearable dry eyes every day for more than 3 months; ② repeated gritty feeling in the eyes; ③ need to use artificial tears 3 times or more every day; ④ dry mouth every day for more than 3 months; ⑤ need to drink water frequently to help swallow dry food. Or suspected SS with at least one system positive in the EULAR SS Patient Disease Activity Index (ESSDAI) questionnaire.

[0025] Exclusion criteria: Patients with the following diseases should be excluded because they may have overlapping clinical manifestations or interfere with diagnostic test results: ① history of head and neck radiotherapy; ② active hepatitis C virus infection (confirmed by PCR); ③ AIDS; ④ sarcoidosis; ⑤ amyloidosis; ⑥ graft-versus-host disease; ⑦ IgG4-related disease.

[0026] Applicable to anyone who meets the inclusion criteria and excludes the exclusion criteria, and those whose total score of the above five items is ≥4 are diagnosed with pSS. Patients who routinely use anticholinergic drugs should fully stop taking the drugs before undergoing the above ③④⑤ items to evaluate dry mouth and eyes.

[0027] 3) Interstitial lung disease meets the diagnostic criteria of Western medicine, referring to the corresponding classification diagnostic criteria reached by the American Thoracic Society and the European Respiratory Society in 2002 and the recommendations of the 2018 Chinese Connective Tissue Disease-Related Interstitial Lung Disease Diagnosis and Treatment Expert Consensus, combined with clinical manifestations and multiple examinations such as chest HRCT and pulmonary function to determine the diagnosis: Those who meet 2 or more of the following 4 items: ① Clinical manifestations: respiratory symptoms such as cough, sputum, wheezing, and chest tightness; ② Pulmonary function test: manifested as restrictive ventilation dysfunction (FVC% <80%) and / or decreased diffusion capacity (DLCO% <80%); ③ Lung HRCT: showing one or more imaging changes of interstitial pneumonia, manifested as thickening of interlobular septa, subpleural arc shadows, ground-glass shadows, consolidation shadows, lattice shadows or honeycomb shadows; ④ Lung biopsy: manifested as thickening of alveolar septa, lymphocyte infiltration, collagen deposition, and fibrosis. Among them, FVC% is the percentage of forced vital capacity in the predicted value, and DLCO% is the percentage of carbon monoxide diffusion capacity in the predicted value.

[0028] 4) pSS-ILD is diagnosed as lung deficiency and collateral arthralgia in TCM, which is formulated according to the relevant contents of the "Guidelines for Clinical Research of New Chinese Medicines" and "Practical TCM Rheumatology", and with reference to previous clinical experience and relevant literature. Clinical manifestations include: dry mouth, dry eyes, cough, dry cough without sputum or cough with little sputum, shortness of breath or shortness of breath when moving, chest tightness or chest tightness when moving, fatigue, joint pain, dry and dull skin, dark tongue or ecchymosis, little or no coating, and thin pulse.

[0029] 5) The ESSDAI (Sjögren's Syndrome Disease Activity Index) score indicates that the lung lesions are at a low to medium activity, which means that the lung function shows FVC% ≥ 60% and DLCO% ≥ 40%;

[0030] 6) The subjects were informed and voluntarily signed the informed consent.

[0031] 1.2 Exclusion criteria

[0032] 1) Patients with other connective tissue diseases; 2) Patients with severe mental or neurological diseases; 3) Patients who are pregnant, preparing for pregnancy or breastfeeding; 4) Patients with serious lesions of important organs such as the heart, liver, kidney, blood, and endocrine system; 5) Patients with tumors; 6) Patients with known allergies or intolerance to the components of this drug; 7) Patients who are participating in other drug trials.

[0033] 2. Treatment options

[0034] 2.1 Dosage regimen

[0035] Basic treatment: Hydroxychloroquine sulfate tablets, oral, 2 times a day, 200 mg each time

[0036] Treatment group: basic treatment was performed and the Chinese medicine composition of the present invention (prepared in Example 1) was taken at the same time. One dose of the Chinese medicine composition of the present invention was taken per day, and the daily dose of the Chinese medicine composition of the present invention was divided into two portions, one portion was taken orally in the morning and the other in the evening, and the course of treatment was 12 weeks.

[0037] Chinese medicine control group: basic treatment was performed, and control Chinese medicine composition (prepared in Example 1) was taken at the same time. One dose of control Chinese medicine composition was taken per day, and the daily dose of control Chinese medicine composition was divided into two portions, one portion was taken orally in the morning and the other in the evening, and the course of treatment was 12 weeks.

[0038] Western medicine control group: basic treatment was carried out, and acetylcysteine ​​was taken orally, twice a day, 600 mg each time, for 12 weeks.

[0039] 2.2 Observation indicators

[0040] 1) European League Against Rheumatism Sjögren's Syndrome Patient Reported Index (EULAR) Syndrome Patient Reported Index (ESSPRI) is used to evaluate the condition of pSS patients. ESSPRI score (scoring method see Seror R, Ravaud P, Mariette X, Bootsma H, Theander E, Hansen A, Ramos-Casals M, T, Bombardieri S, Hachulla E, Brun JG, Kruize AA, Praprotnik S, Tomsic M, GottenbergJE, ​​Devauchelle V, Devita S, Vollenweider C, Mandl T, Tzioufas A, Carsons S, Saraux A, Sutcliffe N, Vitali C, Bowman SJ; EULAR Task Force. EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI): development of a consensus patient index for primary Sjogren's syndrome. Ann Rheum Dis. 2011 Jun; 70 (6): 968-72.) includes three main symptom dimensions: dryness (including dry mouth, dry eyes, dry skin, etc.), fatigue and pain (including joint and muscle pain, etc.). Scoring method: The ESSPRI score uses the Visual Analogue Scale (VAS) to allow patients to rate the severity of each symptom from 0 (no symptoms) to 10 (most severe symptoms) based on their own feelings. The final ESSPRI score is the average of these three symptom scores. The higher the score, the more severe the condition. The modified Medical Research Council Dyspnoea Scale (mMRC) is a scoring tool used to assess the degree of dyspnea in patients with chronic obstructive pulmonary disease (COPD) (for specific scoring methods, see the Respiratory Equipment Technology Professional Committee of the Chinese Medical Equipment Association, the Chronic Obstructive Pulmonary Disease Group of the Respiratory Branch of the Chinese Medical Association, and the Guangdong Pharmaceutical Association. Expert consensus on medical and pharmaceutical co-management of stable chronic obstructive pulmonary disease [J]. Chinese Journal of Tuberculosis and Respiratory Diseases, 2022, 45(10): 980-987.). It can also be used to assist in assessing the severity of symptoms in patients with interstitial lung disease. It is scored according to the degree of dyspnea that occurs when the patient performs different activities, and is divided into 5 levels. The severity of the patient's symptoms can be judged based on the mMRC score. The ESSPRI score and mMRC score were collected once before treatment and 12 weeks after treatment.

[0041] 2) TCM syndrome score (reference standard: "Guidelines for Clinical Research of New Chinese Medicines" and "Standards for Diagnosis and Efficacy of TCM Diseases and Syndromes"), to evaluate the clinical symptoms of pSS-ILD patients. The main symptoms include dry mouth, dry eyes, cough, and shortness of breath. The specific scoring method is shown in Table 2. TCM syndrome score was collected once before and after treatment.

[0042] Table 2 Quantitative table of TCM syndrome score for Sjögren's syndrome combined with interstitial lung disease

[0043]

[0044] 3) Safety indicators: routine blood tests and liver and kidney function tests were collected once before treatment and 12 weeks after treatment, and adverse reactions were recorded at any time.

[0045] 2.3 Efficacy determination

[0046] 1) Clinical efficacy assessment

[0047] This document was developed with reference to the 2002 edition of “Guidelines for Clinical Research of New Chinese Medicines”.

[0048] Clinical remission: After treatment, symptoms and signs such as dry mouth, dry eyes, cough, and shortness of breath basically disappeared (patients felt that their symptoms had improved by ≥90%), respiratory function recovered (patients felt that their respiratory function had improved by ≥90%), and major examination indicators (ESSPRI score decreased by ≥90% and mMRC score decreased by ≥90%) returned to normal.

[0049] Markedly effective: After treatment, symptoms and signs such as dry mouth, dry eyes, cough, and shortness of breath were significantly improved (70%≤patients' self-perceived symptom improvement<90%), respiratory function was improved (70%≤patients' self-perceived respiratory function improvement<90%), and major examination indicators tended to normal (70%≤ESSPRI score decreased<90% and 70%≤mMRC score decreased<90%).

[0050] Effective: After treatment, symptoms and signs such as dry mouth, dry eyes, cough, and shortness of breath were improved (50%≤patients' self-perceived symptom improvement<70%), symptoms were aggravated after continuous activity, and the values ​​of major examination indicators were improved (50%≤ESSPRI score decreased<70% and 50%≤mMRC score decreased<70%).

[0051] Ineffective: Failure to meet effectiveness criteria or even deterioration.

[0052] 2) Criteria for determining efficacy of TCM syndromes

[0053] According to the 2002 edition of the "Guidelines for Clinical Research of New Chinese Medicines", the formula nimodipine method is used for calculation: reduction of TCM syndrome score = (TCM syndrome score before treatment - TCM syndrome score after treatment) / TCM syndrome score before treatment × 100%.

[0054] Markedly effective: clinical symptoms and signs of TCM are significantly improved, and the TCM syndrome score is reduced by ≥70%;

[0055] Effective: TCM clinical symptoms and signs are improved, and the TCM syndrome score is reduced by ≥50% and <70%;

[0056] Improvement: TCM clinical symptoms and signs are improved, and the TCM syndrome score is reduced by ≥20% and <50%;

[0057] Ineffective: There is no significant improvement in TCM clinical symptoms and signs, or they may even get worse, and the reduction in TCM syndrome scores is less than 20%.

[0058] 3. Treatment outcomes

[0059] 3.1 Comparison of clinical efficacy and TCM syndrome efficacy among the three groups (see Tables 1 and 2)

[0060] The clinical efficacy and TCM syndrome efficacy of the treatment group were greater than those of the Western medicine control group, and the difference was statistically significant (p < 0.05), indicating that the treatment group had better efficacy. There was no statistically significant difference in clinical efficacy and TCM syndrome efficacy between the treatment group and the TCM control group (p > 0.05), indicating that the TCM efficacy of the two groups was equivalent.

[0061] Table 1 Comparison of clinical efficacy among three groups [n(%)]

[0062]

[0063] Note: Total effective rate = (clinical remission + marked effect + effective) / number of cases × 100%; *, compared with the western medicine control group, there is a significant difference, p < 0.05.

[0064] Table 2 Comparison of the efficacy of TCM syndromes in three groups [n(%)]

[0065]

[0066] Note: Total effective rate = (marked effect + effective + improved) / number of cases × 100%; *, compared with the western medicine control group, there is a significant difference, p < 0.05.

[0067] 3.2 Comparison of safety indicators among the three groups before and after treatment

[0068] After treatment, there were no obvious abnormalities in blood routine, liver and kidney functions in the three groups, indicating that the three groups of medication had no obvious effects on blood routine, liver and kidney functions.

[0069] In summary, the Chinese medicine composition of the present invention has a simple formula, can effectively improve the condition of pSS-ILD, and has no obvious side effects.

[0070] Example 3 Typical case of pSS-ILD treated with the Chinese medicine composition of the present invention

[0071] Case 1: Mao, female, 66 years old, first visit (June 17, 2022), the patient has a history of Sjögren's syndrome (meet the 2016 American College of Rheumatology / European League Against Rheumatism classification criteria for primary Sjögren's syndrome) for more than 11 years. She has developed cough and shortness of breath in the past two years and usually takes hydroxychloroquine sulfate tablets orally for treatment. Two years ago, she had a lung CT scan due to cough and shortness of breath, which showed interstitial inflammation and localized pulmonary fibrosis in both lungs (flake-like reticular shadows and linear shadows in the lower lobes of both lungs), and a history of gastritis. One week ago, the antinuclear antibody (ANA) titer was 1:1000, anti-SSA antibody and anti-Ro52 antibody were both (+), immunoglobulin (Ig) G antibody: 23.49g / L; rheumatoid factor (RF): 239IU / mL; erythrocyte sedimentation rate (ESR) 27mm / h; ESSDAI score was 12 points, and the lung lesions in the ESSDAI score were in low to medium activity, that is, the lung function indicated that FVC% was 100% and DLCO% was 66%. At present: dry skin without luster, obvious dry mouth and dry eyes, swallowing dry food requires drinking water, blurred vision, gum atrophy, occasional cough, yellow sputum difficult to cough up, fatigue and weakness, shortness of breath when moving, chest tightness when moving, dull pain and discomfort in finger joints, occasional morning stiffness, good appetite, regular bowel movements, good sleep at night, purple tongue, slightly greasy tongue coating with cracks in the middle, and fine and smooth pulse. Western medicine diagnosis: Sjogren's syndrome combined with interstitial lung disease; Chinese medicine diagnosis: lung arthralgia (lung deficiency and collateral arthralgia syndrome). Treatment: replenishing qi and nourishing yin, moistening the lungs and unblocking collaterals. Prescription: 12g of northern radix adenophorae, 10g of ophiopogon, 25g of Pseudostellariae Pseudostellariae, 10g of roasted silkworm, 20g of curcuma, and 25g of golden buckwheat. Take each of the medicinal materials in the prescription, add water and decoct twice, add 800ml of water each time, take the two decoctions and mix them, a total of 300ml, and obtain a daily dose of Chinese medicine composition, which is divided into two portions and taken orally in the morning and evening. After taking the medicine for 1 week, there was no obvious relief of dry mouth and dry eyes, coughing and expectoration still occurred, and the sputum color was yellow. After taking the initial prescription for half a month, the dry mouth and dry eyes improved, the cough improved, the sputum was refreshing, the sputum color turned white, and the joint pain was not obvious. The initial prescription was continued for a total treatment time of 3 months, and all symptoms were significantly alleviated. After statistical analysis, it was found that the clinical efficacy was significant and the Chinese medicine syndrome efficacy was significant.

[0072] Case 2: Zhu, female, 75 years old, first visit (July 7, 2024), the patient had dry mouth and dry eyes for more than 1 year and cough for half a year. One year ago, there was no obvious cause for dry mouth and dry eyes, but no attention was paid. Half a year ago, cough and less sputum gradually appeared. Intermittent oral cough syrup had no obvious effect. Later, the cough gradually worsened. In July 2024, he was treated in the respiratory department. HRCT showed mild interstitial inflammation and fibrosis in both lungs (a few grid shadows and cord shadows were seen in the lower lobes of both lungs). The antinuclear antibody (ANA) titer was 1:100, and the lip gland biopsy showed that it was consistent with chronic inflammatory cell infiltration level IV. It was diagnosed as Sjögren's syndrome combined with interstitial lung disease (see Example 2 for specific diagnostic methods), and hormones, immunosuppressants and traditional Chinese medicine treatment (10g of Ophiopogon japonicus, 10g of Pseudostellaria heterophylla, 6g of Schisandra chinensis, 10g of Angelica sinensis, 10g of Bombyx batryticatus, 12g of Plum, 10g of Periostracum cicadae, 10g of fried white peony root, 6g of Bupleurum chinense), and the symptoms did not improve significantly. At present: obvious dry mouth and dry eyes, swallowing dry food requires drinking water, frosted feeling in both eyes, joint pain, obvious fatigue, palpitation, occasional chest tightness, cough, slight wheezing, dry and dull skin, good appetite, good sleep, smooth bowel movements, frequent urination, dark tongue, slightly greasy fur with cracks in the middle and back, stringy and slippery pulse, ESSDAI score of 10 points, lung function indicates FVC% is 100% and DLCO% is 68%. Western medicine diagnosis: Sjögren's syndrome combined with interstitial lung disease; Chinese medicine diagnosis: lung arthralgia (lung deficiency and collateral arthralgia syndrome). Treatment: replenish qi and nourish yin, moisten the lungs and dredge the collaterals. Initial diagnosis prescription: 12g of Adenophora australis, 10g of Ophiopogon japonicus, 25g of Radix Pseudostellariae Pseudostellariae, 20g of Curcuma zedoariae, 25g of Fagopyrum scabrae, and 10g of roasted Bombyx batryticatus. Take each medicinal material in the initial diagnosis prescription, add water and decoct twice, add 800ml of water each time, take two decoctions and mix them, a total of 300ml, obtain a daily dose of Chinese medicine composition, divide it into two portions, and take one portion orally in the morning and evening. After taking it for 1 week, the patient reported that cough and asthma were relieved, phlegm stagnation in the throat, dry mouth and dry eyes were still obvious, and fatigue. After continuing to take the initial diagnosis prescription for half a month, the symptoms of dry mouth were significantly relieved, asthma was not obvious, fatigue and cough were better than before. Because the stool was not formed, 12g of Poria was added to the initial diagnosis prescription. After taking it for half a month, dry mouth and asthma were not obvious, and cough was significantly improved. Continue to take the initial diagnosis prescription until the total treatment time reaches 3 months, and all symptoms are alleviated. After statistical analysis, it was found that the clinical efficacy is significant and the efficacy of Chinese medicine syndrome is significant.

Claims

1. A Chinese medicine composition for treating primary Sjögren's syndrome combined with interstitial lung disease, characterized in that The invention is prepared from the following Chinese medicinal raw materials in parts by weight: 10-15g of Glehnia littoralis, 10-15g of Radix Ophiopogonis, 15-30g of Radix Pseudostellariae, 10-20g of Rhizoma Curcumae, 6-12g of Bombyx Batryticatus and 15-30g of Fagopyrum scabra.

2. The Chinese medicine composition according to claim 1, characterized in that The invention is prepared from the following Chinese medicinal raw materials in parts by weight: 12g of Glehnia littoralis, 10g of Radix Ophiopogonis, 25g of Radix Pseudostellariae, 20g of Rhizoma Curcumae, 10g of Bombyx Batryticatus and 25g of Fagopyrum scabra.

3. The method for preparing the Chinese medicine composition according to claim 1, characterized in that The method comprises the following steps: weighing each Chinese medicine raw material, adding water and boiling for 2-5 times, taking the decoction and combining them to obtain the Chinese medicine composition.

4. The preparation method according to claim 3, characterized in that The decoction and a pharmaceutically acceptable carrier are made into tablets, capsules, pills, granules and oral liquids.

5. The preparation method according to claim 4, characterized in that The decoction is concentrated under reduced pressure at 55-65° C. and then made into tablets, capsules, pills, granules and oral liquid.

6. Use of the Chinese medicine composition according to claim 1 in the preparation of a medicament for treating primary Sjögren's syndrome combined with interstitial lung disease.

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