CN111973705A - Traditional Chinese medicine composition for treating interstitial lung disease, pharmaceutical preparation and application - Google Patents

Abstract

The invention particularly relates to a traditional Chinese medicine composition for treating interstitial lung diseases, a pharmaceutical preparation and application. Interstitial lung is pathologically characterized by diffuse lung parenchyma, alveolar inflammation, and interstitial fibrosis, and is associated with the etiology of a variety of diseases, including viral, bacterial, and occupational and environmental inhalant lung diseases. The invention provides a traditional Chinese medicine formula for interstitial lung diseases, which comprises astragalus, white atractylodes rhizome fried with bran, divaricate saposhnikovia root, salvia miltiorrhiza, prepared rehmannia root, Chinese yam fried with bran, cornus wine, poria cocos, epimedium and radix ophiopogonis. The composition can be made into powder and pill with effects of invigorating lung and kidney, invigorating spleen and promoting blood circulation, and is suitable for patients with qi deficiency of lung, spleen and kidney. Also has good effect on treating various interstitial lung diseases and new coronary diseases corresponding to the diseases of abnormal circulation of qi, blood and body fluid and deficiency of the lung, spleen and kidney at the later stage of the novel coronary pneumonia.

Description

Traditional Chinese medicine composition for treating interstitial lung disease, pharmaceutical preparation and application

Technical Field

The invention belongs to the field of medicines for treating interstitial lung diseases, and particularly relates to a traditional Chinese medicine composition for treating the interstitial lung diseases, a pharmaceutical preparation and application of the traditional Chinese medicine composition in preparation of medicines or health-care products for treating the interstitial lung diseases.

Background

The information in this background section is only for enhancement of understanding of the general background of the invention and is not necessarily to be construed as an admission or any form of suggestion that this information forms the prior art that is already known to a person of ordinary skill in the art.

Interstitial Lung Disease (ILD) refers to a group of diseases resulting from interstitial injury to the lung, involving the alveolar wall and surrounding tissues. It has been found that over 180 known diseases can affect the pulmonary interstitium, and for the convenience of clinical classification, the etiology of interstitial lung diseases can be classified as known or unknown. The largest group of causes are occupational and environmental inhalation diseases, and infection-related ILD is also common, such as viral pneumonia and pneumocystis infection can be induced; idiopathic interstitial pneumonia, collagen vascular disease/connective tissue disease in unknown etiology are also large in number. With the development of modern society, the probability of people contacting dust, related medicines and other chemical preparations is increased, the number of patients suffering from rheumatism immune system diseases is increased, and the number of the diseases of interstitial lung diseases is increased earlier due to various reasons, so that the disease is one of the factors harming public health.

Viral infection is one of the causes of ILD, and the imaging of patients with novel coronavirus pneumonia can show the change of pulmonary interstitium, the injury of multiple organs of a human body caused by the infection can be related to inflammatory storm, oxidative stress free radical accumulation and apoptosis, and the apoptosis of lung capillary endothelial cells and alveolar epithelial cells damages the structural integrity and the function of alveolar capillary barriers, thereby being capable of initiating interstitial lesion.

The traditional Chinese medicine considers that the disease is a disease of a series of related symptoms such as cough and asthma and ascending qi caused by insufficient vital qi, incontinent ying and defending, invasion of pathogenic qi such as wind, cold and dampness, blockage of channels and collaterals, entering the lung and incapability of smooth qi and blood circulation, and the lung function is in a low state. Therefore, the inventor thinks that the effective control of the disease progress by means of combination of traditional Chinese medicine and western medicine becomes the key point of the current research and has great significance.

Disclosure of Invention

The invention provides a traditional Chinese medicine formula with a remarkable curative effect for treating interstitial lung diseases, the formula is derived from a protocol formula of a subsidiary hospital of Shandong traditional Chinese medicine university, the formula is prepared by cutting classical famous prescription of Yupingfeng powder and six ingredients of rehmannia into pills, the formula is refined and strict, and the traditional Chinese medicine formula gives consideration to the lung, spleen and kidney, is widely used for treating interstitial lung disease patients clinically and belongs to patients with lung, spleen and kidney qi deficiency, and has a reliable curative effect.

The invention firstly provides a traditional Chinese medicine composition, which comprises the following medicinal ingredients: radix astragali, rhizoma Atractylodis Macrocephalae, radix Saposhnikoviae, radix Salviae Miltiorrhizae, radix rehmanniae Preparata, rhizoma Dioscoreae, fructus Corni, Poria, herba Epimedii, and radix Ophiopogonis.

Astragalus membranaceus is dried root of Astragalus membranaceus Bge. Astragalus membrane aceus (Fisch.) of Leguminosae family or Astragalus membranaceus Bge. Hsiao. Collected in spring and autumn, removed fibrous root and head, and dried in the sun. Sweet and warm. It enters lung and spleen meridians. Tonify qi, strengthen superficies, induce diuresis, expel pus, heal wound and promote tissue regeneration. Can be used for treating deficiency of vital energy, asthenia, anorexia, loose stool, collapse of middle-warmer energy, chronic diarrhea, rectocele, hematochezia, metrorrhagia, superficial deficiency, spontaneous perspiration, qi deficiency, edema, carbuncle, cellulitis, intractable ulcer, blood deficiency, debility with yellowish complexion, internal heat, and diabetes; proteinuria due to chronic nephritis and diabetes.

Atractylodis rhizoma is dried rhizome of Atractylodes macrocephala Koidz of Compositae. In winter, the lower leaves are withered and yellow, and the upper leaves are brittle, picked and dug, sand and sand are removed, and then the leaves are dried or dried in the sun, and fibrous roots are removed.

In the preferred scheme of the invention, the processing form of the white atractylodes rhizome, namely stir-frying the white atractylodes rhizome with bran, is adopted, the honey-fried bran is scattered into a hot pot, the white atractylodes rhizome slices are added when smoking, stir-frying is carried out until the white atractylodes rhizome slices are brown and burnt fragrance escapes, and then the honey-fried bran is taken out and sieved. Every 100kg of the white atractylodes rhizome tablets are roasted by 10kg of bran with honey. Bitter, sweet and warm. It enters spleen and stomach meridians. Invigorate spleen, replenish qi, dry dampness, induce diuresis, stop sweating, prevent abortion. Can be used for treating spleen deficiency, anorexia, abdominal distention, diarrhea, phlegm retention, dizziness, palpitation, edema, spontaneous perspiration, and threatened abortion. Tu Bai Zhu strengthens spleen, harmonizes stomach and prevents abortion. Can be used for treating spleen deficiency, anorexia, diarrhea, loose stool, and threatened abortion.

Ledebouriella root, a dried root of the plant Saposhnikovia divaricata (Turcz.) switzerland, of the family umbelliferae, schischchk. Digging roots of plants without flower stems in spring and autumn, removing fibrous roots and silt, and drying in the sun. Pungent, sweet and warm. It enters bladder, liver and spleen meridians. Relieve exterior syndrome, dispel wind, subdue dampness and stop spasm. Can be used for treating common cold, headache, rheumatalgia, rubella, pruritus, and tetanus.

Salvia miltiorrhiza, is dried root and rhizome of Salvia miltiorrhiza Bunge of Labiatae. Collected in spring and autumn, removed of silt and dried. Bitter and slightly cold. It enters heart and liver meridians. Dispel stasis and alleviate pain, activate blood and dredge meridians, clear heart fire and relieve restlessness. Can be used for treating menoxenia, amenorrhea, dysmenorrhea, abdominal mass, thoracico-abdominal pain, arthralgia due to heat, pyocutaneous disease, swelling and pain, vexation, and insomnia; hepatosplenomegaly, angina pectoris.

Radix rehmanniae Preparata is processed product of radix rehmanniae, which is fresh or dried root tuber of Rehmannia glutinosa Libosch of Scrophulariaceae. Collected in autumn, removed the reed heads, fibrous roots and silt, and slowly baked rehmannia to about eight dry roots, known as "Sheng Di Huang".

The processing method comprises the following steps: (1) taking clean radix rehmanniae, stewing with wine according to wine stewing method (appendix II D) until the wine is absorbed completely, taking out, airing until the mucus on the outer skin is slightly dry, cutting into thick pieces or blocks, and drying to obtain the final product. 30-50 kg of yellow wine is used for every 100kg of radix rehmanniae recen.

(2) Taking clean radix rehmanniae, steaming to black and moist by steaming method (appendix II D), taking out, drying to about eight dry, cutting into thick pieces or blocks, and drying to obtain the final product.

The radix rehmanniae Preparata can be processed by the above method.

Sweet and warm. It enters liver and kidney meridians. To nourish yin, enrich blood, replenish essence and replenish marrow. Can be used for treating deficiency of liver-yin and kidney-yin, soreness of waist and knees, hectic fever, night sweat, nocturnal emission, internal heat, diabetes, blood deficiency, sallow complexion, cardiopalmus, severe palpitation, menoxenia, metrorrhagia, metrostaxis, hemorrhage, giddiness, tinnitus, and early white beard and hair.

Rhizoma Dioscoreae is dried rhizome of Dioscorea opposita Thunb of Dioscoreaceae. Digging after withering of stems and leaves in winter, cutting off root heads, cleaning, removing outer skins and fibrous roots, fumigating with sulfur, and drying; optionally selecting dry rhizoma Dioscoreae, soaking in clear water until there is no dry core, sealing, fumigating with sulfur, cutting, twisting into cylinder with wood plate, sun drying, and polishing. Dioscorea japonica Thunb, a congeneric plant, is wild in various parts of China. Its root is also used as yam and has similar action.

In the technical scheme preferred by the inventor, the processed yam fried with bran is adopted: the Jingshan medicinal tablet is taken and fried to yellow according to a bran frying method (appendix II D of the first edition of Chinese pharmacopoeia 2015). Sweet and neutral. It enters spleen, lung and kidney meridians. Tonify spleen and stomach, promote the production of body fluid and nourish lung, tonify kidney and astringe essence. Can be used for treating spleen deficiency, anorexia, chronic diarrhea, lung deficiency, cough, asthma, spermatorrhea, leukorrhagia, frequent micturition, and diabetes due to deficiency heat. The bran-parched rhizoma Dioscoreae has effects of invigorating spleen and invigorating stomach. Can be used for treating spleen deficiency, anorexia, diarrhea, loose stool, and leukorrhagia.

Cornus officinalis is dried mature pulp of Cornus officinalis Sieb. Collecting fruit when pericarp turns red in late autumn and early winter, baking with slow fire or slightly scalding in boiling water, removing fruit core in time, and drying.

The invention preferably selects the processed product of the wine dogwood fruit: mixing fructus Corni with yellow wine, placing in a pot or other container, sealing, steaming in water until the wine is absorbed completely, taking out, and air drying (20 jin yellow wine per 100 jin). Sour, astringent and slightly warm. It enters liver and kidney meridians. Tonify liver and kidney, astringe essence and relieve depletion. Can be used for treating vertigo, tinnitus, soreness of waist and knees, sexual impotence, spermatorrhea, enuresis, frequent micturition, metrorrhagia, leukorrhagia, sweating, asthenia, internal heat, and diabetes.

Poria is dried sclerotium of Wolf of Poria cocos (Schw.) belonging to Polyporaceae. And (4) digging for more than 7-9 months, removing silt after digging, piling up to generate sweat, spreading and airing until the surface is dry, generating sweat again, repeating for a plurality of times until wrinkles appear and most of internal water is lost, and drying in the shade. Sweet, bland and mild. It enters heart, lung, spleen and kidney meridians. Induce diuresis and drain dampness, invigorate spleen and calm heart. Can be used for treating edema, oliguria, phlegm and fluid retention, dizziness, palpitation, spleen deficiency, anorexia, loose stool, diarrhea, uneasiness, palpitation, and insomnia.

Herba Epimedii is dry aerial part of Epimedium brevicornum Maxim of berberidaceae, Epimedium sagittatum Maxim of Epimedium sagittatum (Sieb. et Zucc.) of Epimedium sagittatum, Epimedium pubescens Maxim, Epimedium wushanense T.S.ying, or Epimedium koreanum Nakai. Collecting and cutting in summer and autumn when stem and leaf are flourishing, removing coarse stalk and impurity, and sun drying or shade drying. Pungent, sweet and warm. It enters liver and kidney meridians. Tonify kidney yang, strengthen tendons and bones, dispel wind-damp. Can be used for treating sexual impotence, spermatorrhea, tendons and bones flaccidity, rheumatalgia, numbness and contracture; climacteric hypertension.

Radix Ophiopogonis is dried root tuber of Ophiopogon japonica (Thunb.) Ker-Gawl. of Liliaceae. Collected in summer, cleaned, repeatedly exposed to the sun, piled until the seven-eight dry, removed fibrous root, and dried. Sweet, slightly bitter and slightly cold. It enters heart, lung and stomach meridians. Nourish yin, promote the production of body fluid, moisten lung and clear away heart-fire. Can be used for treating dry cough due to lung dryness. Cough due to consumptive disease, thirst due to body fluid consumption, vexation, insomnia, internal heat, diabetes, constipation due to intestinal dryness; and (4) pharyngeal diphtheria.

The existing research shows that the Jade-screen polysaccharide and Jade-screen total glycosides have certain prevention and treatment effects on experimental liver fibrosis models, and the Jade-screen powder can realize the prevention and treatment effects on respiratory virus infection through anti-inflammation and immunocompetence regulation, so that the Jade-screen polysaccharide and Jade-screen total glycosides have certain alleviation effects on viruses and interstitial lung diseases accompanied with inflammation. In the research process, the study considers that the qi, blood and body fluid running disorder, the deficiency of the lung, spleen and kidney, the blood circulation and hypodynamia, the blood stasis as blood stasis and the mutual influence of phlegm stasis and qi deficiency can be seen in the later stages of interstitial lung disease, pulmonary fibrosis, pneumonia and the like. Especially for patients with deficiency of lung, spleen and kidney qi, with symptoms of cough, chest distress, short breath, asthma, asthenia, spontaneous perspiration, anorexia, fullness, soreness of waist and knees, dizziness, tinnitus, deafness, and constipation. The invention adopts two classic formulas of jade screen powder and six-ingredient rehmannia pill, on the basis, the salvia miltiorrhiza is added to play roles of activating blood and dissolving stasis, clearing away heart fire and relieving restlessness, the epimedium is used for warming yang and tonifying kidney, and the ophiopogon root is used for nourishing yin, promoting the production of body fluid and moistening lung, so that the medicine can play a role of tonifying lung and kidney, invigorating spleen and activating blood integrally, and has good curative effect. In the formula, the astragalus root, which enters lung and spleen channels, invigorates qi and raises yang, and benefits defensive qi and strengthens superficies, is the monarch drug. The Chinese yam has the effects of supplementing qi, nourishing yin and tonifying spleen, lung and kidney; parching Atractylodis rhizoma, invigorating spleen and stomach channels, invigorating qi and spleen, eliminating dampness and promoting diuresis; prepared rehmannia root, radix rehmanniae Praeparata has the effects of nourishing blood, nourishing yin, entering kidney, replenishing essence and benefiting marrow, and is used as a ministerial drug for nourishing and filling three zang organs. Radix Saposhnikoviae enters liver and spleen channels, and has effects of dispelling pathogenic wind, relieving exterior syndrome, eliminating dampness, relieving pain, invigorating spleen, invigorating qi, strengthening and protecting skin surface, and preventing pathogen from entering again. The wine of cornus officinalis has the effects of tonifying liver and kidney, astringing and inducing astringency, and the combination of prepared rehmannia root and Chinese yam takes the meaning of 'three tonification' in the pill of six ingredients with rehmannia, and emphasizes on nourishing yin and tonifying kidney, and consolidating foundation. Poria, entering heart, spleen and kidney meridians, can drain dampness, invigorate spleen, calm mind and tranquilize mind; for yang qi, if it is on the same day, herba Epimedii can be added to warm and tonify yang qi, dispel wind and remove dampness; mai Dong can strengthen the action of promoting the production of body fluid and moistening lung. In addition, because long-term qi deficiency can promote blood circulation, reduce fatigue and stop blood circulation to be stasis, the formula is supplemented with Danshen root, which can promote qi and blood circulation. The medicines are combined to play the roles of tonifying lung and kidney, strengthening spleen and activating blood circulation.

In a second aspect, the invention provides a pharmaceutical preparation for treating interstitial lung diseases, wherein the pharmaceutical preparation is an oral preparation, and specifically is one of decoction, pill, powder, soft extract, tablet, granule, capsule, syrup, mixture, dripping pill, extract or bagged steeping drug.

In a third aspect of the present invention, there is provided an application of the Chinese medicinal composition of the first aspect and the pharmaceutical preparation of the second aspect in a medicament/health product for treating interstitial lung disease.

Also specifically included in the use are treatments for novel coronavirus pneumonia. The late stage of the new coronary pneumonia has abnormal circulation of qi, blood and body fluids, and deficiency of the lung, spleen and kidney. The traditional Chinese medicine formula provided by the invention conforms to the characteristics of the disease symptoms of patients with new coronary pneumonia in the recovery period, can promote the recovery of the patients, improve the life quality and prevent sequelae from being left.

The beneficial effects of one or more technical schemes are as follows:

1. the toxicity test proves that the pharmaceutical composition is safe to use. Clinical examination verifies that the medicine formula can effectively improve various traditional Chinese medicine symptoms of the lung, spleen and kidney qi deficiency syndrome of the interstitial lung disease, and the clinical treatment effect is obvious.

2. Starting from the manifestation of qi deficiency of lung, spleen and kidney of patients with interstitial lung diseases, the combination of two classic formulas of Yupingfeng powder and Liuwei Dihuang pill is conjectured to improve the interstitial lung diseases by the mechanisms of tonifying lung and kidney, strengthening spleen and activating blood. Promotes the research progress of the traditional medicine aiming at interstitial lung diseases and provides a new treatment idea.

Detailed Description

It is to be understood that the following detailed description is exemplary and is intended to provide further explanation of the invention as claimed. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.

It is noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of exemplary embodiments according to the invention. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, and it should be understood that when the terms "comprises" and/or "comprising" are used in this specification, they specify the presence of stated features, steps, operations, devices, components, and/or combinations thereof, unless the context clearly indicates otherwise.

Interpretation of terms:

the interstitial lung disease is a general term of clinical-pathological entities consisting of different disease groups with pathological basic lesions of diffuse lung parenchyma, alveolar inflammation and interstitial fibrosis and clinical manifestations of active dyspnea, diffuse infiltration shadow of X-ray chest radiograph, restrictive airway dysfunction, Diffuse (DLCO) function reduction and hypoxemia.

Culturing primordial energy: the pharmaceutical composition provided by the invention is an agreed prescription of the first subsidiary hospital of Shandong Chinese medicine university, which is called as 'Baiyuan', and represents the following medicinal flavors and content ratios: 18g of astragalus root, 15g of white atractylodes rhizome stir-fried with bran, 9g of divaricate saposhnikovia root, 12g of red sage root, 12g of prepared rehmannia root, 15g of yam stir-fried with bran, 9g of cornus officinalis, 12g of poria cocos, 15g of epimedium herb and 12g of dwarf lilyturf tuber per dose.

In order to solve the above technical problems, the present invention provides a Chinese medicinal composition for treating an interstitial lung disease, which is introduced in the background art.

The invention firstly provides a traditional Chinese medicine composition, which comprises the following medicinal ingredients: astragalus root, white atractylodes rhizome, ledebouriella root, red sage root, prepared rehmannia root, Chinese yam, cornus fruit, poria cocos, epimedium and ophiopogon root.

Preferably, the bighead atractylodes rhizome is bran-fried bighead atractylodes rhizome.

Preferably, the yam is bran-fried yam.

Preferably, the dogwood is wine dogwood.

In one embodiment of the above preferred embodiment, the Chinese medicinal composition comprises the following medicinal ingredients: radix astragali, Atractylodis rhizoma parched with bran, radix Saposhnikoviae, Saviae Miltiorrhizae radix, radix rehmanniae Preparata, rhizoma Dioscoreae parched with bran, Corni fructus, Poria, herba Epimedii and radix Ophiopogonis.

Preferably, the invention also provides the following traditional Chinese medicine compositions in parts by weight: 15-22 parts of astragalus membranaceus, 12-18 parts of bighead atractylodes rhizome, 7-11 parts of divaricate saposhnikovia root, 10-14 parts of red-rooted salvia root, 10-14 parts of prepared rehmannia root, 12-18 parts of Chinese yam, 7-9 parts of dogwood, 10-14 parts of poria cocos, 13-18 parts of epimedium herb and 9-15 parts of radix ophiopogonis.

Further preferably, the weight part of the astragalus is 17-19 parts.

Further preferably, the weight part of the bran-fried bighead atractylodes rhizome is 14-16 parts.

Further preferably, the weight part of the salvia miltiorrhiza is 9-13 parts.

Further preferably, the weight parts of the bran-fried Chinese yam are 14-16 parts.

Further preferably, the weight part of the epimedium is 14-16 parts.

Preferably, in the traditional Chinese medicine composition, the traditional Chinese medicine raw materials and the parts by weight thereof are as follows: 16-20 parts of astragalus membranaceus, 13-17 parts of bran-fried bighead atractylodes rhizome, 8-10 parts of divaricate saposhnikovia root, 10-14 parts of salvia miltiorrhiza, 10-14 parts of prepared rehmannia root, 13-17 parts of bran-fried Chinese yam, 8-10 parts of cornus officinalis, 10-14 parts of poria cocos, 13-17 parts of epimedium and 10-14 parts of radix ophiopogonis.

In a specific embodiment provided by the invention, the traditional Chinese medicine composition comprises 18 parts of astragalus membranaceus, 15 parts of bran-fried bighead atractylodes rhizome, 9 parts of divaricate saposhnikovia root, 12 parts of salvia miltiorrhiza, 12 parts of prepared rehmannia root, 15 parts of bran-fried Chinese yam, 9 parts of cornus wine, 12 parts of poria cocos, 15 parts of epimedium and 12 parts of radix ophiopogonis.

In another specific embodiment, the Chinese medicinal composition comprises, by weight, 17 parts of astragalus membranaceus, 14 parts of bran-fried bighead atractylodes rhizome, 8 parts of divaricate saposhnikovia root, 11 parts of salvia miltiorrhiza, 10 parts of prepared rehmannia root, 13 parts of bran-fried Chinese yam, 8 parts of cornus wine, 10 parts of poria cocos, 13 parts of epimedium and 10 parts of radix ophiopogonis.

In another specific embodiment, the Chinese medicinal composition comprises 19 parts by weight of astragalus, 16 parts by weight of white atractylodes rhizome stir-fried with bran, 10 parts by weight of ledebouriella root, 13 parts by weight of salvia miltiorrhiza, 14 parts by weight of prepared rehmannia root, 17 parts by weight of yam stir-fried with bran, 10 parts by weight of cornus wine, 14 parts by weight of poria cocos, 16 parts by weight of epimedium herb and 14 parts by weight of ophiopogon root.

In another specific embodiment provided by the present invention, the Chinese medicinal composition comprises the following medicinal herbs in parts by weight: 18 parts of astragalus, 15 parts of bighead atractylodes rhizome, 9 parts of divaricate saposhnikovia root, 12 parts of red sage root, 12 parts of prepared rehmannia root, 15 parts of Chinese yam, 9 parts of dogwood, 12 parts of poria cocos, 15 parts of epimedium herb and 12 parts of dwarf lilyturf tuber.

Preferably, the traditional Chinese medicine composition further comprises a flavor of added and subtracted medicines, wherein the added and subtracted medicines comprise one or more of raw dragon oyster, American ginseng, spina date seed, light wheat, parasitic loranthus, dendrobium, fried earthworm, cicada slough, ligusticum wallichii, rhizoma polygonati and cassia twig.

The interstitial lung patients often suffer from cough and oppression, and also cause problems of sleep, tinnitus, hypodynamia and the like. The pharmaceutical composition has the effects of tonifying lung and kidney, strengthening spleen and promoting blood circulation, and can be used for treating by matching with medicines with the effects of calming heart and tranquilizing mind, arresting sweating and inducing astringency, reducing phlegm and relieving cough and the like.

The raw dragon oyster is two medicaments of raw dragon bone and raw oyster, which are commonly combined and called as raw dragon oyster.

Os Draconis is skeleton fossil of ancient mammals such as elephant, Rhinoceros, and radix et rhizoma Rhei. It is thick and big like animal bones and has different sizes. The surface is gray white or yellow white, and is smooth, and has textures and cracks or brown stripes and spots. Hard, uneven cross section, white, fine and powdery. The joint is expanded, and the section of the joint is provided with a plurality of honeycomb-shaped small holes. The moisture absorption capacity is also strong. No odor and no taste. Sweet, astringent and mild in nature and taste. Tranquilizing, astringing sweat and essence, promoting granulation and healing wound. Can be used for treating neurasthenia, palpitation, insomnia, dreaminess, spontaneous perspiration, night sweat, spermatorrhea, enuresis, metrorrhagia, and leukorrhagia; it is indicated for chronic ulcer without astringency.

The Concha Ostreae is the shell of Ostrea gigas Thunberg, Ostrea talienhanensis Crosse or Ostrea rivularis Gould of Ostrea. The raw Concha Ostreae is prepared by cleaning Concha Ostreae, drying, and grinding. It enters liver, gallbladder and kidney meridians. To tranquilize the mind, subdue yang, tonify yin, soften hardness and dissipate nodulation. Can be used for treating palpitation, insomnia, vertigo, tinnitus, scrofula, subcutaneous nodule, and abdominal mass. Calcined oyster shell astringes and astringes. Can be used for treating spontaneous perspiration, night sweat, spermatorrhea, metrorrhagia, gastralgia, and acid regurgitation.

American ginseng, which is the dried root of Panax quinquefolium L. All are cultivated, harvested in autumn, cleaned, dried in the sun or dried at low temperature. Sweet, slightly bitter and cool. Tonify qi, nourish yin, clear heat and promote fluid production. Can be used for treating deficiency of qi and yin, internal heat, cough, asthma, phlegm blood, asthenia, fever, vexation, fatigue, diabetes, xerostomia, and dry throat.

Semen Ziziphi Spinosae is dry mature seed of Ziziphus jujuba Mill.var. spinosa (Bunge) Hu ex H.F.Chou belonging to Rhamnaceae. Parching semen Ziziphi Spinosae, collecting clean semen Ziziphi Spinosae, parching to swell and slightly darken according to clear parching method (appendix II D), and mashing when it is used, also called parching semen Ziziphi Spinosae.

Blighted wheat, a dry, light, shrunken and thin fruit of the Triticum aestivum l. Harvesting when the fruit is mature, taking the wheat grains which are shrivelled, thin, light and floating and have not been peeled off, removing impurities, screening out dust, rinsing with water, and drying in the sun. Sweet and cool. Relieve deficient sweating, nourish heart and induce tranquilization. Can be used for treating asthenia, hyperhidrosis, and hysteria.

Herba Taxilli is dry stem and branch with leaves of Taxillus chinensis (DC.) Danser of Taxilliaceae. Harvesting in winter to spring, removing coarse stem, cutting into segments, and drying, or steaming and drying. Bitter, sweet and neutral. It enters liver and kidney meridians. Tonify liver and kidney, strengthen tendons and bones, dispel wind-damp, and prevent abortion. Can be used for treating rheumatalgia, soreness of waist and knees, weakness of tendons and bones, metrorrhagia, metrostaxis, and pregnant hemorrhage; hypertension is caused.

Dendrobium nobile, is the Orchidaceae plant Dendrobium lindrigescens loddigesii Rolfe, herba Verbenae Dendrobii fimbriatum hook.var. Collected all the year round, and the fresh one removes roots and silt; the dried leaves are harvested, the impurities are removed, the leaves are slightly scalded or baked with boiled water, and then the leaves are rubbed and dried at the same time until the leaf sheaths are rubbed and cleaned, and the leaves are dried. After cutting off part of fibrous roots, the dendrobium officinale is twisted into a spiral shape or a spring shape while being fried, and then is dried, so that the dendrobium officinale is called as the earring dendrobium. Sweet and slightly cold. It enters stomach and kidney meridians. To nourish stomach, promote the production of body fluid, nourish yin and clear heat. Can be used for treating yin deficiency and fluid deficiency, dry mouth, polydipsia, anorexia, retching, asthenic fever after disease, and dim and unclear vision.

Pheretima, which is a dried body of Pheretima aspergillum (E.Perrier), Pheretima vulgaris Chen, Pheretima williamsii guillain, Pheretima guillielmi (Michaelsen), or Pheretima pectinifera Michaelsen, belonging to the family Membranaceae. Salty and cold. It enters liver, spleen and bladder meridians. Clear heat and calm fright, dredge meridians, relieve asthma and induce diuresis. Can be used for treating hyperpyrexia, unconsciousness, epilepsy, convulsion, arthralgia, numbness of limbs, hemiplegia, cough and asthma due to lung heat, oliguria, edema, and hypertension. Because the earthworms have heavy fishy smell, the fried earthworms are mostly adopted clinically, namely the fried earthworms.

Cicada slough, also called periostracum cicadae, is the rind shell shed when the larvae of cicada family insects, Cryptotympana pustulata Fabricius, eclosion. Collected in summer and autumn, removed of silt and dried in the sun. Sweet and cold in nature. It enters lung and liver meridians. Dispel wind and remove heat, relieve sore throat, promote eruption, remove nebula and relieve spasm. Can be used for treating wind-heat type common cold, pharyngalgia, hoarseness, measles without adequate eruption, rubella pruritus, conjunctival congestion, nebula, convulsion, and tetanus.

Ligusticum wallichii, dried rhizome of Ligusticum chuanxiong Hort (or Ligusticum wallichi Franch.) belonging to Umbelliferae. In summer, when the node disc on the stem is prominent and is slightly purple, the stem is dug, silt is removed, the stem is dried in the sun, and fibrous roots are removed. Pungent and warm. It enters liver, gallbladder and pericardium meridians. Promote blood circulation and move qi, dispel wind and alleviate pain. Can be used for treating menoxenia, amenorrhea, dysmenorrhea, abdominal pain, pricking pain in chest and hypochondrium, traumatic injury, swelling and pain, headache, and rheumatalgia.

Rhizoma Polygonati is dried rhizome of Polygonatum kingianum Coll et Hemsl, Polygonatum sibiricum Red or Polygonatum cyrtonema Hua of Liliaceae. According to different shapes, it is commonly called "rheum officinale essence", "polygonatum capitatum" and "polygonatum zingiberense". Collected in spring and autumn, removed fibrous root, cleaned, slightly scalded in boiling water or steamed until it is thoroughly steamed, and dried. Sweet and neutral. It enters spleen, lung and kidney meridians. Tonify qi and yin, invigorate spleen, moisten lung and tonify kidney. Can be used for treating weakness of spleen and stomach, asthenia, xerostomia, anorexia, lung deficiency, cough, essence and blood deficiency, and internal heat diabetes.

Cassia twig, a dried twig of Cinnamomum cassia Cassia Presl of Lauraceae. Collected in spring and summer, leaves are removed, and the tea is dried in the sun or sliced and dried in the sun. Pungent, sweet and warm. It enters heart, lung and bladder meridians. Induce sweating to relieve muscles, warm and dredge meridians, strengthen yang to transform qi, and smooth the flow of qi. Can be used for treating wind-cold type common cold, abdominal psychroalgia, blood cold amenorrhea, arthralgia, phlegm retention, edema, palpitation, and galloping.

The above medicines can be added according to patient's performance, such as hyperhidrosis, debilitation, difficulty in sleep, palpitation, etc., and optionally Os Draconis and Concha Ostreae, herba Taxilli, and radix Panacis Quinquefolii; semen Ziziphi Spinosae and fructus Tritici Levis can be added for treating dyssomnia and night sweat; for patients who are afraid of cold and have pain in hypochondrium, ramulus Cinnamomi and rhizoma Ligustici Chuanxiong may be added.

In a second aspect of the present invention, there is provided a use of the Chinese medicinal composition of the first aspect in preparing a medicament for treating pulmonary diseases.

Preferably, the pulmonary disease includes, but is not limited to, interstitial lung disease; the interstitial lung disease is a general term of clinical-pathological entities consisting of different disease groups with pathological basic lesions of diffuse lung parenchyma, alveolar inflammation and interstitial fibrosis and clinical manifestations of active dyspnea, diffuse infiltration shadow of X-ray chest radiograph, restrictive airway dysfunction, Diffuse (DLCO) function reduction and hypoxemia.

Preferably, the preparation for resisting the lung diseases comprises a medicament and a health-care product for resisting the lung diseases.

The third aspect of the invention provides a medicament for treating interstitial lung diseases, wherein the raw materials of the medicament comprise the traditional Chinese medicine composition of the first aspect and pharmaceutically necessary auxiliary materials.

Preferably, the traditional Chinese medicine composition and the extract of the traditional Chinese medicine composition are used as active ingredients.

Further preferably, the extract of the Chinese medicinal composition accounts for 1-99% of the total amount of the medicament, and the medicament is in a unit dosage form suitable for single administration of precise dosage.

In other embodiments, the amount of the drug ranges from about 0.001mg/kg body weight/day to about 1000mg/kg body weight/day.

In other embodiments, the amount of the drug ranges from about 0.5mg/kg body weight/day to about 50mg/kg body weight/day.

In some embodiments, the amount of the drug is from about 0.001 g/day to about 7 g/day.

In other embodiments, the amount of drug is from about 0.002 g/day to about 6 g/day.

In other embodiments, the amount of the drug is from about 0.005 g/day to about 5 g/day.

In other embodiments, the amount of the drug is from about 0.01 g/day to about 5 g/day.

In other embodiments, the amount of the drug is from about 0.02 g/day to about 5 g/day.

In other embodiments, the amount of the drug is from about 0.05 g/day to about 2.5 g/day.

In other embodiments, the amount of the drug is from about 0.1 g/day to about 1 g/day.

In other embodiments, dosage levels below the lower limit of the aforesaid range may be more than adequate.

In other embodiments, dosage levels above the upper limit of the range recited above may be desired.

Preferably, the medicine is an oral preparation, and can be an oral liquid preparation such as decoction, suspension, syrup, mixture, tincture and the like, and can also be an ointment, a granule, a pill (honeyed pill, water pill, paste pill, wax pill and concentrated pill), a powder, a tablet (enteric-coated tablet, film-coated tablet, sugar-coated tablet, extract tablet, dispersible tablet, scratch tablet), a capsule, a drop and the like.

In a more preferred embodiment, the medicament is a decoction, specifically, a water decoction, and is prepared by a conventional water decoction method, wherein the raw materials are weighed according to a ratio, soaked in water for a period of time, decocted, filtered to obtain a decoction, the water decoction operation is repeated, and the filtrates are combined to obtain the decoction.

In other preferred embodiments, the medicament is an ointment, and the preparation method of the ointment is as follows:

soaking the weighed medicinal materials in water for a period of time, decocting, mixing decoctions obtained by several times of decoction, standing, adding crystal sugar, colla Corii Asini and Mel into the supernatant obtained after standing, stirring, collecting the ointment until the ointment is hung on flag in winter and silk in summer, cooling, and packaging.

The dosages of the crystal sugar, the donkey-hide gelatin and the honey are adjusted according to the drug properties, and the dosage of the donkey-hide gelatin and the honey is reduced due to the release of the sticky and greasy medicine after decoction.

In some embodiments, the method of preparing the paste is as follows: cleaning the medicinal materials weighed according to the proportion, putting the medicinal materials into a clean cloth bag, putting the cloth bag into a stainless steel barrel, adding cold water for soaking, continuously turning over the medicine bag in the period, wherein the soaking standard is that medicinal material decoction pieces are pinched by hands without hard core; putting the soaked medicinal materials and liquid medicine into a decocting machine, adding appropriate amount of water, and decocting for 2 times with special requirement of 3 times or prolonged time; after the decoction is finished, combining the two decoction liquids, and standing for 24 hours for later use; concentrating the supernatant, adding crystal sugar, colla Corii Asini, Mel, etc., and stirring; wherein, precious medicinal materials such as American ginseng, red ginseng, pilose antler, sun-dried ginseng and the like are decocted for 2 to 4 hours, the decoction is combined with the concentrated solution, and the concentrated solution is filtered and sieved; concentrating the filtered medicinal liquid, adding precious medicinal fine powder liquid (such as Cordyceps and Notoginseng radix), stirring, mixing, and collecting the ointment until the ointment is in the form of flag hanging in winter and thread hanging in summer; pouring the collected soft extract into a clean paste packaging machine, and subpackaging into small bags of 25g each; and (4) moving the packed paste square small bag to a paste cooling room for natural cooling, wherein when the indoor temperature is high, cold air of an air conditioner can be used for cooling.

Because many patients with interstitial lung diseases need to take the medicine for a long time, the ointment has the characteristics of convenient carrying and taking, and is widely applied clinically.

In other preferred embodiments, including but not limited to a spray, aerosol, dry powder inhaler or inhalation suspension.

The medicine of the invention mainly acts on the lung, is administrated by adopting an inhalation mode, and has the effects of directly reaching the affected part and quickly entering blood.

In other preferred embodiments, the medicament is an injection, including but not limited to an intravenous, intramuscular, and subcutaneous injection, and specifically may be an injection, an emulsion, or a sterile powder.

Further preferably, the interstitial lung disease is a novel coronary pneumonia.

Preferably, the medicament also comprises other active ingredients.

Further preferably, the other active ingredients comprise Chinese patent medicines and chemical entity medicines; wherein the Chinese patent medicine includes but is not limited to Bailing capsule, Danqi soft capsule, Xuefu Zhuyu oral liquid, Zhilingzhi capsule and Liuwei Dihuang pill; the chemical entity drugs include but are not limited to prednisone, calqi, rabeprazole, melbine, nintedanib, pirfenidone.

In the research process of the invention, the Chinese patent medicine and the chemical entity medicine can be used together with the Chinese medicinal composition, and have good clinical treatment effect. According to the above combination, those skilled in the art can combine the Chinese medicinal composition preparation and extract provided by the present invention with the above-mentioned drugs as active ingredients to develop a drug for treating interstitial lung disease.

In order to make the technical solutions of the present invention more clearly understood by those skilled in the art, the technical solutions of the present invention will be described in detail below with reference to specific embodiments.

Example 1

And (3) safety test:

the following safety tests are carried out on decoction obtained by decocting 18 parts of astragalus root, 15 parts of white atractylodes rhizome fried with bran, 9 parts of divaricate saposhnikovia root, 12 parts of red sage root, 12 parts of prepared rehmannia root, 15 parts of yam fried with bran, 9 parts of cornus wine, 12 parts of poria cocos, 15 parts of epimedium and 12 parts of dwarf lilyturf tuber in water.

(1) Acute toxicity test:

1. pharmaceutical preparation

The medicines are purchased in a traditional Chinese medicine pharmacy of a subsidiary hospital of Shandong traditional Chinese medicine university and are identified to meet the standard specified by the quality standard of pharmacopoeia of 2015 edition. Weighing 3 preparations of the formula of the Chinese medicinal herbs according to a certain proportion, cleaning, removing silt, decocting, concentrating, drying by a dryer to obtain 100g (containing 3.87g/g of crude drug) of dry extract powder, preparing into suspension with maximum gavage concentration of 4.5g/ml, subpackaging, sealing, and refrigerating at-4 ℃ for later use.

2. Dosage to be administered

The clinical dose of the culture prescription for adults is about 2.15g of crude drug/kg (namely, the clinical adult daily dose is 129g of crude drug/60 kg to 2.15g of crude drug/kg, and the adult body weight is 60 kg), the total cumulative drug amount is 258.0g of crude drug/kg as the experimental dose (which is 120 times of the clinical dose), for example, the mouse is 200g, the crude drug dose is required to be 51.6g, the dose is reduced to 13.3g of dry extract powder, and the dose of the administered suspension is 3 ml. 180-220 g SD rats are selected, the traditional Chinese medicine composition is continuously infused into the stomach for 3 times within 12 hours, each time interval is 4 hours, within 7 days after administration, the rat diet and behavior activities are observed to be normal, the hair is smooth, the glossiness is good, the response is sensitive, the activity is active and good, the breath is stable, the body weight is increased day by day, and no special adverse performance is caused after each other. At 8d, the rats are sacrificed, gross anatomy and pathological histology examination is carried out, and the pathology of main organs is observed, so that no abnormality is found, which indicates that the traditional Chinese medicine composition has no acute toxic reaction.

(2) Long-term toxicity test:

1 preparation of the drug

The medicines are purchased in a traditional Chinese medicine pharmacy of a subsidiary hospital of Shandong traditional Chinese medicine university and are identified to meet the standard specified by the quality standard of pharmacopoeia of 2015 edition. Weighing 3 preparations of the above formula, cleaning, removing silt, soaking for 30min with a proper amount of horizontal line, boiling with strong fire, decocting with slow fire for 30min, decocting for 2 times, collecting two decoctions of each formula, and concentrating to obtain three water decoctions of 1g/ml (for low dose group administration), 2g/ml (for middle dose group administration) and 4g/ml (for high dose group administration). Subpackaging, sealing, and refrigerating at-4 deg.C for use.

2 dose setting

Generally, the highest dose of the rats in 3 months in the long-term toxicity test is 50-200 times of the clinical dose. Considering that the clinical dose of the primordial prescription for adults is about 2.15g crude drug/kg (i.e. the daily dose of clinical adults is 129g crude drug/60 kg to 2.15g crude drug/kg, and the weight of adults is 60 kg), 129.0g crude drug/kg is taken as the highest dose (corresponding to 60 times of the clinical dose) of the experiment, and the middle dose group is further taken as 64.5g crude drug/kg (corresponding to 30 times of the clinical dose) and the low dose group is further taken as 32.25g crude drug/kg (corresponding to 15 times of the clinical dose of adults) for 3 dose gradients, and the solvent control is further taken as the blank control group.

3 operating step

According to the dose settings described above, 80 SD rats were randomly assigned to vehicle control groups and to high, medium and low 3 dose groups of 20 animals each, male and female halves. The intragastric volume does not exceed 20mL/kg body weight, and the intragastric volume of the blank control group is the dosage of the liquid medicine required by the intragastric administration of the rats in the high-dose group under the condition of the same body weight. In the administration period, the administration amount of each dose group is overlarge within 1 day, so the total administration amount is divided into 2 parts, the administration is carried out once every day at 8-10 am and 4-6 pm, and the administration dose is the same twice every day. Sacrificed after 2 months of continuous gavage. The rats were observed for general conditions such as food intake, body weight, physical signs and behavioral activity and stool. The determination of hematology and biochemistry related indices parallels systematic dissection and histopathology examination. The results show that rats are generally good and have no obvious change. The liver and kidney function is not abnormal, which shows that the traditional Chinese medicine composition is safe and non-toxic.

Clinical data

First, diagnosis standard

Western diagnostic criteria for interstitial lung disease

Diagnosis of interstitial lung disease should be performed by comprehensive assessment in combination with patient history, symptoms, signs, general system examination, chest imaging examination (CT/HRCT), lung function, etc.

1. The main symptoms are: has clinical symptoms such as progressive dyspnea and persistent dry cough;

2. physical signs: the lungs can hear and Velcro Ro sound, and cyanosis, clubbing (toe) and the like can be seen in the late stage;

CT/HRCT performance: abnormal interstitial changes such as frosted glass shadow, irregular lung edge, leaflet spacing, pleural downline, reticular shadow, bronchial vascular bundle abnormality, honeycomb lung and the like occur.

4. Pulmonary function tests showed limited ventilation dysfunction and gas exchange dysfunction: reduction of lung volume: lung volume (TLC), reduced lung Volume (VC), maximum mid-expiratory flow (MMEF), normal forced expiratory volume percentage in the first second (FEV 1/FVC%); diffuse dysfunction: a decrease in DLco; disorders of ventilation/perfusion: PaO₂And (4) descending.

Chinese medicine diagnosis standard for interstitial lung disease

Is made according to the traditional Chinese medicine diagnosis and treatment guidelines (2013 revision) of the lung disease professional committee of Shandong traditional Chinese medicine society and the guidance principles of clinical research on new traditional Chinese medicines.

The main symptoms are: cough, expectoration, chest distress, short breath, asthenia, anorexia, and soreness of waist and knees; the secondary symptoms are as follows: spontaneous perspiration, fullness and distention, dizziness, blurred vision, tinnitus, deafness, and constipation; the tongue is pale with white coating and the pulse is fine or deep and weak. The tongue and pulse condition corresponding to the syndrome of qi deficiency of lung, spleen and kidney can be diagnosed when the syndrome of 3 main symptoms is satisfied and the syndrome of 2 secondary symptoms is satisfied.

Second, research method

(one) case selection

1. Inclusion case criteria

(1) Meets the diagnosis standard of interstitial lung disease;

(2) the traditional Chinese medicine distinguishes the syndrome of lung-spleen-kidney qi deficiency;

(3) the age is distributed between 30 and 75 (including 30 years and 75 years), and the nature is not limited;

(4) consent was given to the study and compliance was better predicted.

2. Criteria for excluding cases

(1) Those who do not meet the diagnostic criteria;

(2) those with combined severe acute infections;

(3) severe diseases of the heart, brain, liver, kidney, tumor, endocrine system and hematopoietic system exist;

(4) patients with obnubilation, dementia and various psychoses;

(5) pregnant and lactating women;

(6) not agreeing to the experimenter.

3. Termination criteria

(1) Patients cannot adhere to the therapist for subjective reasons;

(2) acute exacerbation of the disease occurred during the treatment period, and the experimenter cannot be continued to participate;

(3) those with severe adverse events.

(II) treatment

1. Grouping method

Patients treated in my clinic from 1 month in 2018 to 12 months in 2019, the random grouping method is divided into two groups: control group 30 cases and treatment group 28 cases. The difference in symptoms before and after treatment was compared after a period of administration.

2. Method of treatment

(1) Control group

The traditional Chinese medicine and western medicine are combined to a conventional treatment scheme.

(2) Treatment group

The following formula is added or subtracted on the basis of a conventional treatment scheme

The prescription is as follows: 18g of astragalus, 15g of white atractylodes rhizome stir-fried with bran, 9g of divaricate saposhnikovia root, 12g of salvia miltiorrhiza, 12g of prepared rehmannia root, 15g of yam stir-fried with bran, 9g of cornus officinalis, 12g of poria cocos, 15g of epimedium and 12g of dwarf lilyturf tuber. Decocted in water for oral dose, one dose per day.

3. Statistical method

Counting data by X²And (4) checking, wherein variance analysis is adopted for measurement data, and Ridit analysis is adopted for clinical grade data comparison. All the measurement data are used

(mean. + -. standard deviation) as indicated.

Third, the therapeutic effect

Symptom and sign scoring standard

(1) Cough with asthma

0 point for patients without cough;

intermittent cough without affecting normal life and workers, which is 1 point;

frequent cough, which can be normally worked, is 2 points;

severe coughing, affecting work and sleepers, was 3 points.

(2) Suffocating and panting

Those without short air (except for vigorous activity) are 0 point;

the score of 1 is 1 when the walking is fast or the walking is on a gentle slope and the gas is short;

the number of people who need to stop breathing is 2 minutes because dyspnea (suffocating asthma) is slower than that of the same-age people or the people walk on flat ground at the speed of the people;

those who stopped breathing or were unable to move after walking 100 meters or several minutes on flat ground were rated 3.

(3) Debilitation

0 point for patients without hypodynamia;

for occasional outbreaks, score 1;

the counter relapse author was 2 points;

the lasting issue author is 3 points.

(4) Spontaneous perspiration

0 point for patients without spontaneous perspiration;

for patients with local sweating, score 1;

2 points for weak sweat;

the volume of the body with oil is 3 points.

(5) Nano difference of value

For those without tolerance, 0 point is given;

for occasional outbreaks, score 1;

the counter relapse author was 2 points;

the lasting issue author is 3 points.

(6) Soreness and weakness of waist and knees

0 point for patients without soreness and weakness of waist and knees;

for occasional outbreaks, score 1;

the number of the generations is 2;

the lasting issue author is 3 points.

(7) Feeling of fullness in the abdomen

0 point for patients without fullness;

for occasional abdominal fullness, score 1;

for cases with stuffiness, it is divided into 2 points;

frequent stuffiness and fullness is divided into 3 points.

(8) Dizziness and blurred vision

0 point for patients without dizziness;

1 minute for occasional dizziness;

2 points for dizziness and dizzy;

the number of patients with frequent dizziness is 3 points.

(9) Tinnitus and deafness

The score of 0 is for those without tinnitus and deafness;

1 point for tinnitus and deafness patients;

2 points are given for patients with tinnitus and deafness;

for those with frequent tinnitus and deafness, the score is 3.

(10) Weakness of stool

0 point for patients without constipation;

for occasional weak stools, 1 point is given;

2 points for patients with weak stool;

frequent constipation is classified into 3 points.

(11) White coating of tongue

No white coating on the tongue, which is 0 point;

the tongue with white coating is 1 point.

(12) The thready or deep and weak pulse

No pulse is fine or deep and weak, which is 0 point;

the pulse is 1 minute, fine or deep and weak.

(II) evaluation criteria of symptom signs: and evaluating the curative effect according to the change of the integral of the symptoms and the signs.

(III) therapeutic criteria for pulmonary interstitial fibrosis

Disease efficacy criteria: refer to the standard of curative effect for diagnosing the disease of traditional Chinese medicine and the guiding principle of clinical research of new traditional Chinese medicine of the Ministry of health of the people's republic of China, and combine the comprehensive judgment of symptoms, sign integration and the like.

(1) Clinical control clinical symptoms and signs disappear or basically disappear, and the syndrome score is reduced by more than or equal to 95 percent.

(2) The clinical symptoms and physical signs are obviously improved, and the syndrome integral is reduced by more than or equal to 70 percent.

(3) Effective clinical symptoms and physical signs are improved, and the syndrome integral is reduced by more than or equal to 30 percent.

(4) The clinical symptoms and physical signs are not obviously improved or even aggravated, and the syndrome score is reduced by less than 30%.

(IV) clinical efficacy comparison of two groups of patients

The clinical treatment of 58 patients with pulmonary interstitial fibrosis is carried out, wherein 28 patients in a treatment group and 30 patients in a control group are evaluated and statistically treated according to comprehensive curative effect evaluation standards, and the result shows that 5 patients in the treatment group are clinically cured, 17.86%, 2 patients with obvious effect, 7.14%, 78.57% of total effective rate, 2 patients in the control group are clinically cured, 6.67%, 1 patient with obvious effect, 3.33% and 33.33% of total effective rate, and the treatment group is obviously superior to the control group (P <0.05), which is detailed in table 1.

TABLE 1 comparison of clinical efficacy of two groups of patients

Note: two group comparisons p <0.05

Four, typical cases

1. Shi, gender, woman, age 70, ethnic group, deny the history of drug allergy. The past medical history: rheumatoid arthritis 13 years, hypertension 13 years; deny the history of coronary heart disease, diabetes, hepatitis, tuberculosis. Occupation: farmers, not breeding poultry.

The patient in the hospital comes 23 days 7 and 7 in 2018, the patient has cold and low fever after self-complaint and self-repair before 6 years, and the patient is diagnosed with interstitial pneumonia in the hospital and does not have special treatment when going through chest CT. Intermittent chest distress and shortness of breath begin to appear two years ago, and antibiotics and hormone treatment are given after the visit of a local hospital, which is not detailed and has poor curative effect. In 2017, 11 months, the doctor visits a department of thoracic hospitals in province, carries out lung CT, diagnoses interstitial pneumonia, and gives methylprednisolone and prednisone for treatment, and the curative effect is not obvious after 9 months.

When the patient is in a first visit, the patient suffers from intermittent chest distress and shortness of breath, does not have cough and expectoration, feels white nasal discharge, has white saliva in the mouth, is sensitive to pungent smells such as cold air, oil smoke and the like, suffers from chest distress and shortness of breath, profuse sweat, chilliness, hypodynamia, no acid regurgitation, heartburn and poor sleep, and is difficult to fall asleep. Arthralgia of the whole body, no tooth flake falling, dry eyes, dry mouth, dry throat and convenient adjustment.

Decocting herba Epimedii, parched Lumbricus, and fructus Tritici Levis in water; the capsule can be used in combination with prednisone, Callqi, Ganoderma mycelium, and capsule for invigorating lung and promoting blood circulation.

The patient is subjected to a re-diagnosis in 2018, 9 and 14 days, and the patient complains that he was admitted to the hospital for treatment in 2018, 8, 7 and 8, 24 days, and then is discharged after improvement, and the prescription of the traditional Chinese medicine for cultivating yuan, the prednisone, the lily capsule, the calqi, the digoxin and the ginseng and pine capsule for nourishing the heart are continuously taken after discharge. The sufferers can relieve the chest distress earlier, no cough and expectoration exist, the sufferers have chest distress slightly during the exercise, the sufferers get worse after the exercise, climb up two floors when climbing stairs, have intolerance of cold, lack of strength, no running nose and nasal obstruction, can take the medicine, have poor sleep and are difficult to sleep.

2. Patients with Tian Yi, sex men, age 74, national Han, deny history of drug allergy.

The patient still takes the medicine when visiting the hospital 6/5 days in 2018, and the symptoms of the medicine taking are not obviously relieved, and hormone is not adopted. The symptoms at that time included: dry cough, no phlegm, itching and cough in throat, even cough with pharyngalgia, short breath after movement, climbing 3 storied buildings, sleep-receiving, and convenient adjustment.

Decocting herba Epimedii, nidus Vespae, periostracum Cicadae, parched Lumbricus, and rhizoma Ligustici Chuanxiong in water, and mixing with prednisone and CallQi. The repeated diagnosis of 7 and 4 days in 2018 shows that the symptoms are relieved, cough and shortness of breath are relieved earlier, even cough has no phlegm, chest distress and shortness of breath after activities are realized, daily activities can be tolerated, no obvious discomfort exists, and the patients can take a sleep and adjust the body. Decocting rhizoma Polygonati and rhizoma Ligustici Chuanxiong with water; it is combined with prednisone and CallQi.

3. Guo of a patient, female of sex, age 53 years, sulfanilamide allergy, deny history of liver and kidney disease. The hospital visits for the first time in 2018, 3 and 28 days, after activities, chest distress, suffocation asthma and shortness of breath are progressively aggravated for 1 year, cough is 3 years, and aggravation is 4 months. The patients self-describe: cough is easily caused in autumn and winter, and can be relieved by medication. In 2014, dry cough is more frequent, and double pulmonary fibrosis is seen in chest CT. The physician visits Guangzhou medical university affiliated Hospital 3 months in 2015, and the dosage of prednisone is reduced after 1-3 months. Cough and aggravation at night when patients visit a doctor, unconscious cough with phlegm in pharynx, dyspnea with chest stuffiness and suffocating after activities, sensitivity to pungent smell, no gastric acid, heartburn, unconscious finger swelling, no dry skin, dry eyes, dry throat and mouth, sleep taking, sticky stool and urination.

The decoction is taken by decocting radix rehmanniae Preparata, herba Epimedii and radix Concha Ostreae in water, and then the decoction is taken by using radix rehmanniae Preparata paste. In addition, it is combined with Bulbus Lilii capsule.

The disease of taking medicine is reduced by rechecking in 2018, 9 and 12 months: the cough and chest distress of the patient are relieved before the patient takes the medicine. Chest distress and slight cough appear after the medicine is taken for 9 months. Occasionally cough without obvious time change after treatment, occasionally cough with little yellow phlegm, chest distress and short breath after activity, climbing stairs for 3-4 floors, and slowly walking on the flat ground for tolerance. Has no obvious intolerance of cold, improved sweating, proper physical strength, easy sleep and convenient adjustment.

4. Patients are young, sex men and age 52 years old, and the history of hypertension, diabetes, coronary heart disease and tuberculosis is denied, and drug allergy is denied. Prostate hyperplasia is 10 years old, fatty liver is 10 years old, hepatitis A is 20 years old, smoking is 15 years old, and smoking is stopped for 7 years.

The doctor is firstly seen in the hospital in 2018, 1 month and 25 days, and the dry cough and chest distress are interrupted for 3 years and aggravated for 4 months. The patient began to have slight chest distress and dry cough 3 years ago, occasionally had attacks, was not given importance to treatment, had slightly worsened symptoms since 4 months, and examined chest CT on 12 and 4 months in 2017: the interstitial lesion of the double lungs shows that cough and suffocation symptoms are relieved by local emphysema of the upper right lung lobe, bullous alveoli, oral herbal medicines, cysteine acetate and other medicines.

The cough is not severe in the clinic, the morning attack is short and white, the expectoration is little, and the cough is difficult to be expectorated due to the self-perception of sticky phlegm. Basically, the patient does not have chest distress, suffocates and breathers, but has palpitation, sour regurgitation, heart burning, throat itching cough induced by cold air contact and pungent smell, no ear and nose itching, dry mouth, no obvious discomfort in the rest, sleep receiving and convenient adjustment.

Decocting radix Aconiti lateralis Preparata, herba Epimedii, and Concha Ostreae in water for a certain time, and mixing with unguent for treatment, and Bulbus Lilii capsule, rabeprazole, and DANQI soft capsule.

In 2018, 3 and 6 days, the patients are subjected to the repeated diagnosis, and the medicine taking symptoms are reduced. After the patient takes the medicine, the symptoms of chest distress and cough are improved, and the state of the disease is stable and not repeated. After the re-diagnosis, the ointment formula, the lily capsule, the rabeprazole and the blood stasis removing capsule are continuously adopted for treatment.

The clinical application shows that the formula can effectively improve various traditional Chinese medicine symptoms of the lung, spleen and kidney qi deficiency syndrome of the interstitial lung disease, has good clinical treatment effect and has no adverse reaction in the treatment process.

The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention, and various modifications and changes may be made by those skilled in the art. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims (10)

1. A traditional Chinese medicine composition is characterized by comprising the following medicinal ingredients: astragalus root, white atractylodes rhizome, ledebouriella root, red sage root, prepared rehmannia root, Chinese yam, cornus fruit, poria cocos, epimedium and ophiopogon root.

2. The traditional Chinese medicine composition of claim 1, wherein the Atractylodis rhizoma is bran-parched Atractylodis rhizoma; or the rhizoma Dioscoreae is bran-parched rhizoma Dioscoreae; or the Corni fructus is Corni fructus processed with wine;

preferably, the traditional Chinese medicine composition comprises the following medicinal ingredients: radix astragali, Atractylodis rhizoma parched with bran, radix Saposhnikoviae, Saviae Miltiorrhizae radix, radix rehmanniae Preparata, rhizoma Dioscoreae parched with bran, Corni fructus, Poria, herba Epimedii and radix Ophiopogonis.

3. The traditional Chinese medicine composition of claim 2, wherein the traditional Chinese medicine composition comprises the following medicinal materials in parts by weight: 15-22 parts of astragalus membranaceus, 12-18 parts of bighead atractylodes rhizome, 7-11 parts of divaricate saposhnikovia root, 10-14 parts of salvia miltiorrhiza, 10-14 parts of prepared rehmannia root, 12-18 parts of Chinese yam, 7-9 parts of dogwood, 10-14 parts of poria cocos, 13-18 parts of epimedium herb and 9-15 parts of radix ophiopogonis;

preferably, the weight part of the astragalus is 17-19 parts;

preferably, the weight part of the bran-fried bighead atractylodes rhizome is 14-16 parts;

preferably, the weight part of the salvia miltiorrhiza is 9-13 parts;

preferably, the weight parts of the bran-fried Chinese yam are 14-16 parts;

preferably, the weight part of the epimedium is 14-16 parts;

further preferably, in the traditional Chinese medicine composition, the traditional Chinese medicine raw materials and the parts by weight thereof are as follows: 16-20 parts of astragalus membranaceus, 13-17 parts of bran-fried bighead atractylodes rhizome, 8-10 parts of divaricate saposhnikovia root, 10-14 parts of salvia miltiorrhiza, 10-14 parts of prepared rehmannia root, 13-17 parts of bran-fried Chinese yam, 8-10 parts of cornus officinalis, 10-14 parts of poria cocos, 13-17 parts of epimedium and 10-14 parts of radix ophiopogonis.

4. The Chinese medicinal composition of claim 1, wherein the Chinese medicinal composition further comprises a flavor of modified drugs, and the modified drugs include but are not limited to one or more of raw dragon oyster, American ginseng, plantain seed, spina date seed, light wheat, Chinese taxillus twig, dendrobium, fried earthworm, cicada slough, ligusticum wallichii, rhizoma polygonati, cassia twig, chicken's gizzard-membrane and fructus amomi.

5. Use of the Chinese medicinal composition of any one of claims 1-4 for the preparation of a medicament for treating pulmonary diseases.

6. Use of the Chinese medicinal composition of claim 5 for the preparation of a medicament for treating a pulmonary disease, wherein the pulmonary disease includes, but is not limited to, interstitial lung disease; or the preparation for resisting lung diseases comprises a medicament and a health-care product for resisting lung diseases.

7. A medicament for treating interstitial lung disease, which is characterized in that the raw materials of the medicament comprise the traditional Chinese medicine composition of any one of claims 1 to 4 and pharmaceutically necessary auxiliary materials.

8. The medicament for treating interstitial lung disease according to claim 7, wherein the Chinese medicinal composition according to any one of claims 1 to 4 and the extract of the Chinese medicinal composition are used as active ingredients.

9. The medicament for treating the interstitial lung disease according to claim 7, wherein the medicament is an oral preparation, such as decoction, suspension, syrup, mixture, tincture, and also can be ointment, granules, pills, powder, tablets, capsules or drops.

10. The medicament for treating an interstitial lung disease according to claim 7, wherein the medicament further comprises other active ingredients; preferably, the other active ingredients comprise Chinese patent medicines and chemical entity medicines; wherein the Chinese patent medicine includes but is not limited to lily capsule, soft capsule of red sage root and notoginseng, capsule of removing blood stasis in chest, Zhilingmycelial, pill of six ingredients with rehmannia; the chemical entity drugs include but are not limited to prednisone, calqi, rabeprazole, melbine, nintedanib, pirfenidone.