Traditional Chinese medicine composition and medicinal preparation for nourishing yin and tonifying qi

Abstract

The invention relates to a traditional Chinese medicine composition and a medicinal preparation for nourishing yin and tonifying qi. The traditional Chinese medicine composition comprises radix pseudostellariae, radix ophiopogonis, schisandra chinensis, rhizoma polygonati, dogwood, pseudo-ginseng, radix asteris, perillaseed, almond, ginkgo, earthworm, ginger processed pinellia and honey-fried licorice root. The traditional Chinese medicine composition provided by the invention can achieve the effects of tonifying qi and yin, regulating and tonifying lung and kidney, descending qi and relieving asthma. The traditional Chinese medicine composition can be used for treating lung and kidney deficiency, qi and yin deficiency syndromes, such as shortness of breath and suffocating asthma, and / or chest distress, aggravated movement, dry cough without phlegm or less phlegm, qi deficiency and low sound, fatigue and weakness, sweating and aversion to wind, soreness and weakness of waist and knees, thin shape and loose stool, dysphoria in five hearts, red tongue and little fur, and deep, thin and weak pulse. The traditional Chinese medicine composition can be used for treating diseases in the remission stage of idiopathic pulmonary fibrosis and has a good treatment effect.

Description

[0001] This disclosure claims the priority of a Chinese patent application filed with the National Intellectual Property Administration on May 23, 2023, with application number 202310586060.5 and invention name “A Chinese medicine composition and a pharmaceutical preparation for nourishing Yin and replenishing Qi”, the entire contents of which are incorporated by reference into this disclosure. Technical Field

[0002] The present invention relates to the field of medicine and health technology, and in particular to a Chinese medicine composition and a drug preparation for nourishing yin and replenishing qi. Background Art

[0003] Due to the influence of people's life and environmental factors, the human body is often out of balance, so various diseases will occur. The method of nourishing yin and replenishing qi can treat various diseases caused by deficiency of both qi and yin, and its common symptoms are: chest tightness and shortness of breath, palpitations, fatigue, dizziness and tinnitus, dry mouth and throat, spontaneous sweating, night sweats, hot flashes in the five hearts, poor sleep and dreams, red tongue with less coating, thin and stringy pulse, etc. Some diseases also have symptoms of deficiency of both qi and yin, such as thin body, red tongue, peeling coating, cracks in the middle, fat tongue, and teeth marks on the edges. There are two reasons for this: one is that the body is qi-deficient, and the heat and toxicity are affected, which burns the body fluids over time; the other is that the long-term illness damages yin and consumes qi. The method of replenishing qi and nourishing yin replenishes both qi and yin, replenishes yin essence to transform yang qi, and replenishes yang qi to produce yin essence.

[0004] Idiopathic pulmonary fibrosis (IPF) is a chronic inflammatory interstitial lung disease of unknown etiology. The main pathological features of the disease are idiopathic alveolar interstitial inflammatory response and alveolar structural disorder. Epidemiological studies have shown that the incidence of IPF is about 16.3 / 100,000, and the incidence of acute exacerbation within 3 years is 20.7%. Its pathogenesis is unknown. Currently, there are few effective clinical treatments for the disease. Once it enters the fibrosis stage, except for lung transplantation, a few recommended therapeutic drugs such as pirfenidone can alleviate the decline in lung function, but there is no anti-fibrotic drug that can fundamentally change or reverse IPF. However, due to its high price and the fact that it has not yet been listed in China, it is rarely used in clinical practice. Other drugs or treatments lack strong evidence-based medical support. Therefore, research on the pathogenesis and prevention and treatment of IPF has become an urgent need related to national health and social and economic development.

[0005] In recent years, hypotheses such as inflammation, endoplasmic reticulum stress, epithelial-mesenchymal transition, and oxidative stress have received attention. It is now generally recognized that abnormal repair and excessive deposition of extracellular matrix (ECM) following damage to alveolar epithelial cells are the core pathological mechanisms of IPF. At present, conventional Western medicine treatments include oral nintedanib ethanesulfonate soft capsules and pirfenidone, but they have many adverse reactions. Common adverse reactions to nintedanib ethanesulfonate soft capsules include diarrhea, nausea and vomiting, abdominal pain, loss of appetite, weight loss, and elevated liver enzymes; adverse reactions to pirfenidone include nausea, indigestion, vomiting, anorexia, photosensitivity, rash, and possible liver damage.

[0006] Idiopathic pulmonary fibrosis belongs to the category of "pulmonary tuberculosis and pulmonary paralysis" in traditional Chinese medicine. Traditional Chinese medicine has a long history of understanding this disease and has obvious advantages. Its etiology is mainly due to long-term diseases such as pulmonary tuberculosis, lung abscess, cough and asthma, or wind-dryness and heat evil, wind-cold and dampness evil attacking the lungs, or emotional disorders caused by worry and fatigue, which can cause the lungs to lose nourishment and cause paralysis. According to the theory of traditional Chinese medicine, "qi is the leader of blood" and "qi moves blood", qi deficiency is insufficient to move blood, resulting in blood stasis. Qi deficiency and blood stasis make body fluids resolve phlegm, and phlegm and blood stasis produce toxic evil over time. Therefore, many doctors believe that qi deficiency and blood stasis are the key to the pathogenesis of IPF, which manifests as lung and kidney deficiency and qi and yin deficiency. Traditional Chinese medicine treatment has the advantages of alleviating patient symptoms, improving quality of life, and having few side effects. Therefore, developing a Chinese medicine preparation that nourishes yin and replenishes qi has become a problem to be solved urgently. Summary of the invention

[0007] In order to solve the above technical problems, the present disclosure provides a Chinese medicine composition and a drug preparation for nourishing yin and replenishing qi. The Chinese medicine composition and drug preparation have the effects of replenishing qi and nourishing yin, regulating and tonifying the lungs and kidneys, and relieving asthma, and have a good therapeutic effect on idiopathic pulmonary fibrosis.

[0008] In a first aspect, the present disclosure provides a traditional Chinese medicine composition, comprising: Radix Pseudostellariae, Radix Ophiopogonis, Fructus Schisandrae Chinensis, Radix Polygonati Sinensis, Fructus Corni, Radix Notoginseng, Rhizoma Asteris, Fructus Perillae, Apricot, Ginkgo, Pheretima, Rhizoma Pinelliae Rhizoma and Radix Glycyrrhizae Preparata.

[0009] As a preferred technical solution of the present disclosure, the Chinese medicine composition comprises the following components in parts by weight:

[0010] 55-95 parts of Pseudostellariae Radix, 55-95 parts of Radix Ophiopogonis, 30-70 parts of Schisandrae Chinensis, 55-95 parts of Polygonatum sibiricum, 55-95 parts of Cornus officinalis, 1-40 parts of Panax notoginseng, 30-70 parts of Aster, 40-80 parts of Perilla seeds, 30-70 parts of Apricot, 30-70 parts of Ginkgo, 30-70 parts of Pheretima, 30-70 parts of Pinellia ternata and 20-60 parts of Radix Glycyrrhizae Preparata.

[0011] Among them, the weight proportions of the Pseudostellaria heterophylla can be 58 parts, 60 parts, 62 parts, 65 parts, 68 parts, 70 parts, 72 parts, 75 parts, 78 parts, 80 parts, 82 parts, 85 parts, 88 parts, 90 parts, 92 parts, etc.

[0012] The weight portions of the Ophiopogon japonicus can be 58 parts, 60 parts, 62 parts, 65 parts, 68 parts, 70 parts, 72 parts, 75 parts, 78 parts, 80 parts, 82 parts, 85 parts, 88 parts, 90 parts, 92 parts, etc.

[0013] The weight portions of the Schisandra chinensis can be 32 parts, 35 parts, 38 parts, 40 parts, 42 parts, 45 parts, 48 ​​parts, 50 parts, 52 parts, 55 parts, 58 parts, 60 parts, 62 parts, 65 parts, 68 parts, etc.

[0014] The weight proportions of the polygonatum can be 58 parts, 60 parts, 62 parts, 65 parts, 68 parts, 70 parts, 72 parts, 75 parts, 78 parts, 80 parts, 82 parts, 85 parts, 88 parts, 90 parts, 92 parts, etc.

[0015] The weight proportions of the Cornus officinalis can be 58 parts, 60 parts, 62 parts, 65 parts, 68 parts, 70 parts, 72 parts, 75 parts, 78 parts, 80 parts, 82 parts, 85 parts, 88 parts, 90 parts, 92 parts, etc.

[0016] The weight portions of the Panax notoginseng can be 2 parts, 4 parts, 6 parts, 8 parts, 10 parts, 12 parts, 14 parts, 16 parts, 18 parts, 20 parts, 22 parts, 24 parts, 26 parts, 28 parts, 30 parts, 32 parts, 34 parts, 36 parts, 38 parts, etc.

[0017] The weight proportions of the Aster can be 32 parts, 35 parts, 38 parts, 40 parts, 42 parts, 45 parts, 48 ​​parts, 50 parts, 52 parts, 55 parts, 58 parts, 60 parts, 62 parts, 65 parts, 68 parts, etc.

[0018] The weight proportions of the perilla seeds can be 42 parts, 45 parts, 48 ​​parts, 50 parts, 52 parts, 55 parts, 58 parts, 60 parts, 62 parts, 65 parts, 68 parts, 70 parts, 72 parts, 75 parts, 78 parts, etc.

[0019] The weight portions of the almonds can be 32 portions, 35 portions, 38 portions, 40 portions, 42 portions, 45 portions, 48 ​​portions, 50 portions, 52 portions, 55 portions, 58 portions, 60 portions, 62 portions, 65 portions, 68 portions, etc.

[0020] The weight portions of the ginkgo nuts can be 32 parts, 35 parts, 38 parts, 40 parts, 42 parts, 45 parts, 48 ​​parts, 50 parts, 52 parts, 55 parts, 58 parts, 60 parts, 62 parts, 65 parts, 68 parts, etc.

[0021] The weight proportions of the earth dragon can be 32 parts, 35 parts, 38 parts, 40 parts, 42 parts, 45 parts, 48 ​​parts, 50 parts, 52 parts, 55 parts, 58 parts, 60 parts, 62 parts, 65 parts, 68 parts, etc.

[0022] The weight portions of the ginger pinellia can be 32 parts, 35 parts, 38 parts, 40 parts, 42 parts, 45 parts, 48 ​​parts, 50 parts, 52 parts, 55 parts, 58 parts, 60 parts, 62 parts, 65 parts, 68 parts, etc.

[0023] The weight proportions of the licorice root can be 22 parts, 25 parts, 28 parts, 30 parts, 32 parts, 35 parts, 38 parts, 40 parts, 42 parts, 45 parts, 48 ​​parts, 50 parts, 52 parts, 55 parts, 58 parts, etc.

[0024] As a preferred technical solution of the present disclosure, the Chinese medicine composition comprises the following components in parts by weight:

[0025] 65-85 parts of Pseudostellariae Radix, 65-85 parts of Radix Ophiopogonis, 40-60 parts of Schisandrae Chinensis, 65-85 parts of Polygonatum sibiricum, 65-85 parts of Fructus Corni, 5-35 parts of Notoginseng, 40-60 parts of Aster, 50-70 parts of Fructus Perillae, 40-60 parts of Apricot, 40-60 parts of Ginkgo, 40-60 parts of Pheretima, 40-60 parts of Pinellia Rhizoma and 30-50 parts of Radix Glycyrrhizae Preparata.

[0026] As a preferred technical solution of the present disclosure, the Chinese medicine composition comprises the following components in parts by weight:

[0027] 75 parts of Pseudostellariae Radix, 75 parts of Radix Ophiopogonis, 50 parts of Fructus Schisandrae Chinensis, 75 parts of Rhizoma Polygonati, 75 parts of Fructus Corni, 15-25 parts of Radix Notoginseng, 50 parts of Rhizoma Asteris, 60 parts of Fructus Perillae, 50 parts of Apricot, 50 parts of Ginkgo, 50 parts of Pheretima, 50 parts of Rhizoma Pinelliae Rhizoma and 40 parts of Radix Glycyrrhizae Preparata.

[0028] The compatibility mechanism of the Chinese medicine composition provided by the present disclosure is as follows:

[0029] The main ingredients of this prescription are Radix Pseudostellariae and Radix Polygonati. Radix Pseudostellariae is sweet, slightly bitter and neutral. It enters the spleen and lung meridians. It moistens the body and harmonizes the nature, replenishes qi and produces body fluid. It is mainly used to treat spleen deficiency, poor appetite, fatigue, palpitations and spontaneous sweating, lung deficiency cough, and thirst due to lack of body fluid. Radix Polygonati is sweet and neutral in nature. It enters the spleen, lung and kidney meridians. It has the function of replenishing the middle qi, moistening the lungs and nourishing yin. It can be used for yin deficiency and dry lungs, dry cough and less sputum, and can be used together with Radix Pseudostellariae as the main ingredient.

[0030] The assistant drugs Ophiopogon japonicus and Schisandra chinensis invigorate qi and nourish yin, astringe the lungs and relieve cough, and together with the main drug Pseudostellaria baicalensis, form the famous prescription Shengmai Powder for treating chronic cough with lung deficiency, damage to both qi and yin, dry cough with little sputum; Cornus officinalis is sour in taste, slightly warm in nature, enters the liver and kidney meridians, has the function of invigorating the liver and tonifying the kidney, astringing the essence and consolidating deficiency, and can nourish the kidney and absorb qi when used together with Schisandra chinensis; Aster tataricus is bitter and pungent in taste, slightly warm in nature, enters the lung meridian, has the function of warming the lungs and descending qi, resolving phlegm and relieving cough, and is used for chest tightness and reverse qi, cough and asthma with excessive sputum; Perilla seed is pungent in taste, warm in nature, enters the lung and large intestine meridians, has the function of descending qi and resolving phlegm, relieving cough and relieving asthma, "cough and reverse qi rise, and rapid asthma causes lung distension", Perilla seed can descend qi and calm asthma, Apricot kernel is bitter and warm, can relieve cough, descend qi and relieve asthma, Apricot kernel is bitter and warm, can relieve cough, descend qi and relieve asthma, and these four drugs together can cooperate with the main drug to invigorate the lungs and kidneys, invigorate qi and nourish yin, relieve cough, descend qi and relieve asthma.

[0031] The adjuvant drug Panax notoginseng promotes blood circulation and removes blood stasis, Ginkgo biloba promotes blood circulation and relieves asthma, Pheretima lumbarum has the function of dredging meridians and relieving asthma, and Ginger and Pinellia ternata harmonize the stomach, reduce adverse reactions and stop vomiting.

[0032] The roasted licorice root can harmonize the other medicines.

[0033] The Chinese medicine composition provided by the present disclosure has the effects of invigorating qi and nourishing yin, regulating lung and kidney, and relieving asthma. It nourishes the lungs and nourishes the lungs by nourishing yin and invigorating qi, reduces alveolar "death", and relieves dyspnea by lowering qi and relieving asthma, thereby improving the quality of life. It can be used for lung and kidney deficiency, qi and yin deficiency syndrome, with symptoms of shortness of breath, wheezing, and (or) chest tightness, which worsens with movement, dry cough without sputum or little sputum, weak breath and low voice, fatigue, sweating, aversion to wind, soreness of waist and knees, thin body and loose stools, fever in the five hearts, red tongue with little coating, and deep and weak pulse. The Chinese medicine composition can treat idiopathic pulmonary fibrosis, especially remission stage diseases.

[0034] In a second aspect, the present disclosure provides use of the traditional Chinese medicine composition described in the first aspect in preparing a yin-nourishing and qi-invigorating medicine.

[0035] In a third aspect, the present disclosure provides a Yin-nourishing and Qi-invigorating pharmaceutical preparation, the pharmaceutical preparation comprising the effective ingredients of the traditional Chinese medicine composition described in the first aspect.

[0036] The effective ingredients of the traditional Chinese medicine composition described in the present disclosure can be extracted by the preparation method described in the fourth aspect.

[0037] As a preferred technical solution of the present disclosure, the pharmaceutical preparation further includes an excipient.

[0038] The excipients may be selected from binders, fillers, disintegrants, lubricants, emulsifiers, flavoring agents, cosolvents, solubilizers, colorants, etc. The present disclosure does not impose any particular restrictions on the specific types of the excipients, and those skilled in the art may select them according to actual needs.

[0039] As a preferred technical solution of the present disclosure, the dosage form of the pharmaceutical preparation is tablets, capsules, granules, oral liquid or syrup.

[0040] In a fourth aspect, the present disclosure provides a method for preparing the pharmaceutical preparation according to the third aspect, the preparation method comprising the following steps:

[0041] (1) crushing Panax notoginseng to obtain Panax notoginseng fine powder for later use;

[0042] (2) soaking Radix Pseudostellariae, Radix Ophiopogonis, Fructus Schisandrae Chinensis, Radix Polygonati Sinensis, Fructus Corni, Fructus Asteris, Fructus Perillae, Apricot Kernel, Ginkgo, Pheretima, Rhizoma Pinelliae Rhizoma and Radix Glycyrrhizae in water for water extraction to obtain a water extract;

[0043] (3) preparing the water extract and the Panax notoginseng fine powder into the dosage form of the pharmaceutical preparation.

[0044] As a preferred technical solution of the present disclosure, the soaking time in step (2) is 1-3 hours, for example, 1.2 hours, 1.5 hours, 1.8 hours, 2 hours, 2.2 hours, 2.5 hours or 2.8 hours, etc.

[0045] As a preferred technical solution of the present disclosure, the water extraction method in step (2) is: decocting at least 2 times (for example, 2 times, 3 times, 4 times or 5 times, etc.), each decocting time is 1.5-3 hours (for example, 1.8 hours, 2 hours, 2.2 hours, 2.5 hours or 2.8 hours, etc.).

[0046] As a preferred technical solution of the present disclosure, preparing the water extract and the Panax notoginseng fine powder into the dosage form of the pharmaceutical preparation comprises the following steps:

[0047] The water extract is concentrated to a relative density of 1.05-1.20 at 50°C, ethanol is added to an alcohol content of 65-75%, and the solution is allowed to stand for 12-24 hours. The supernatant is taken, and the ethanol is recovered until there is no alcohol taste, and the solution is concentrated to a relative density of 1.10-1.25 at 50°C, and the solution is mixed with the fine powder of Panax notoginseng, and dried to a dry extract. The dry extract is post-processed to prepare the dosage form of the pharmaceutical preparation.

[0048] As a preferred technical solution of the present disclosure, the dry extract is crushed, mixed with a binder, a wetting agent, a disintegrant and a lubricant, pressed into tablets, and coated with a film.

[0049] As a specific embodiment of the present disclosure, the preparation method comprises the following steps:

[0050] (1) crushing Panax notoginseng to obtain Panax notoginseng fine powder for later use;

[0051] (2) Soak Radix Pseudostellariae, Radix Ophiopogonis, Fructus Schisandrae Chinensis, Radix Polygonati Sinensis, Fructus Corni, Fructus Asteris, Fructus Perillae, Fructus Amygdalus, Fructus Ginkgoe, Pheretima, Rhizoma Pinelliae Rhizoma, and Radix Glycyrrhizae in water for 1-3 h, decoct twice, each time for 1.5-3 h, filter, and combine the filtrates;

[0052] (3) centrifuging the filtrate, taking the supernatant, concentrating it under reduced pressure to a relative density of 1.05-1.20 at 50° C., letting it stand to room temperature, adding ethanol to an alcohol content of 65-75%, letting it stand for 12-24 hours, taking the supernatant, recovering ethanol until there is no alcohol taste, concentrating it under reduced pressure to a relative density of 1.10-1.25 at 50° C., mixing it with the Panax notoginseng fine powder, drying it under reduced pressure to obtain a dry extract (water content ≤ 8%), and crushing it;

[0053] The dry extract is mixed evenly with a binder, a wetting agent, a disintegrant and a lubricant, pressed into tablets, and coated with a film to obtain the product.

[0054] Compared with the prior art, the technical solution provided by the embodiments of the present disclosure has the following advantages:

[0055] (1) The Chinese medicine composition provided by the present disclosure is scientifically matched with Radix Pseudostellariae Radix, Radix Ophiopogonis, Fructus Schisandrae Chinensis, Fructus Corni, Radix Notoginseng, Radix Asteris, Fructus Perillae, Apricot, Ginkgo, Pheretima, Rhizoma Pinelliae Rhizoma and Radix Glycyrrhizae, which can play the role of invigorating qi and nourishing yin, regulating lung and kidney, and relieving asthma. The Chinese medicine composition can be used for lung and kidney deficiency, qi and yin deficiency syndrome, with symptoms of shortness of breath, wheezing, and (or) chest tightness, aggravated by movement, dry cough without sputum or little sputum, weak breath and low voice, fatigue, sweating, aversion to wind, soreness of waist and knees, thin body and loose stools, fever in the five hearts, red tongue with little coating, and deep and weak pulse. The Chinese medicine composition can be used to treat idiopathic pulmonary fibrosis in remission stage, and has good therapeutic effect.

[0056] (2) The pharmaceutical preparation provided by the present invention has a simple prescription, a simple production process, few toxic and side effects, and is convenient to administer. The pharmaceutical preparation is easy to manufacture and has low cost. DETAILED DESCRIPTION

[0057] In order to more clearly understand the above-mentioned objectives, features and advantages of the present disclosure, the scheme of the present disclosure will be further described below. It should be noted that the embodiments of the present disclosure and the features in the embodiments can be combined with each other without conflict.

[0058] In the following description, many specific details are set forth to facilitate a full understanding of the present disclosure, but the present disclosure may also be implemented in other ways different from those described herein; it is obvious that the embodiments in the specification are only part of the embodiments of the present disclosure, rather than all of the embodiments.

[0059] Example 1

[0060] This embodiment provides a traditional Chinese medicine composition, comprising the following components in parts by weight:

[0061] 95 parts of Radix Pseudostellariae Radix, 55 parts of Radix Ophiopogonis, 70 parts of Fructus Schisandrae Chinensis, 55 parts of Rhizoma Polygonati Spermatis, 95 parts of Fructus Corni, 1 part of Radix Notoginseng, 70 parts of Aster, 40 parts of Fructus Perillae, 70 parts of Apricot, 70 parts of Ginkgo, 30 parts of Pheretima, 70 parts of Rhizoma Pinelliae Rhizoma and 20 parts of Radix Glycyrrhizae Preparata.

[0062] This embodiment also provides a tablet for nourishing yin and replenishing qi, and the preparation method thereof is as follows:

[0063] (1) Grind Panax notoginseng into fine powder according to the proportion of the Chinese medicine composition provided in this embodiment and set aside.

[0064] (2) According to the ratio of the Chinese medicine composition provided in this example, 12 herbs including Radix Pseudostellariae, Radix Ophiopogonis, Fructus Schisandrae Chinensis, Radix Polygonati Sinensis, Fructus Corni, Fructus Asteris, Fructus Perillae, Apricot Kernel, Ginkgo, Pheretima, Rhizoma Pinelliae Rhizoma and Radix Glycyrrhizae were taken, soaked in water for 2 hours, boiled twice, each time for 2 hours, filtered and the filtrate was combined;

[0065] (3) The filtrate is centrifuged, the supernatant is taken, and it is concentrated under reduced pressure to a paste with a relative density of 1.10 at 50°C, and then allowed to stand at room temperature. Ethanol is added until the alcohol content reaches 70%, and the mixture is allowed to stand at room temperature for 18 hours. The supernatant is taken, and the ethanol is recovered until there is no alcohol taste, and it is concentrated under reduced pressure to a thick paste with a relative density of 1.20 at 50°C. The paste is mixed with the above-mentioned Panax notoginseng fine powder, and dried under reduced pressure to form a dry extract (water content ≤ 8%), which is crushed and passed through an 80-mesh sieve; appropriate amounts of adhesives, wetting agents, disintegrants, lubricants, etc. are added, mixed evenly, pressed into tablets, and coated with a film.

[0066] Example 2

[0067] This embodiment provides a traditional Chinese medicine composition, comprising the following components in parts by weight:

[0068] 55 parts of Radix Pseudostellariae, 95 parts of Radix Ophiopogonis, 30 parts of Fructus Schisandrae Chinensis, 95 parts of Rhizoma Polygonati Spermatis, 55 parts of Fructus Corni, 40 parts of Radix Notoginseng, 30 parts of Rhizoma Asteris, 80 parts of Fructus Perillae, 30 parts of Apricot Kernel, 30 parts of Ginkgo, 70 parts of Pheretima, 30 parts of Rhizoma Pinelliae and 60 parts of Radix Glycyrrhizae Preparata.

[0069] This embodiment also provides a tablet for nourishing yin and replenishing qi, and the preparation method thereof is as follows:

[0070] (1) Grind Panax notoginseng into fine powder according to the proportion of the Chinese medicine composition provided in this embodiment and set aside.

[0071] (2) According to the ratio of the Chinese medicine composition provided in this example, 12 herbs including Radix Pseudostellariae, Radix Ophiopogonis, Fructus Schisandrae Chinensis, Radix Polygonati, Fructus Corni, Fructus Asteris, Fructus Perillae, Apricot Kernel, Ginkgo, Pheretima, Rhizoma Pinelliae Rhizoma and Radix Glycyrrhizae were taken, soaked in water for 1 hour, boiled twice, each time for 3 hours, filtered and the filtrate was combined;

[0072] (3) The filtrate is centrifuged, the supernatant is taken, and it is concentrated under reduced pressure to a paste with a relative density of 1.20 at 50°C, and then allowed to stand at room temperature. Ethanol is added until the alcohol content reaches 65%, and the mixture is allowed to stand at room temperature for 24 hours. The supernatant is taken, and the ethanol is recovered until there is no alcohol taste, and it is concentrated under reduced pressure to a thick paste with a relative density of 1.25 at 50°C. The paste is mixed with the above-mentioned Panax notoginseng fine powder, and dried under reduced pressure to form a dry extract (water content ≤ 8%), which is crushed and passed through an 80-mesh sieve; appropriate amounts of adhesives, wetting agents, disintegrants, lubricants, etc. are added, mixed evenly, pressed into tablets, and coated with a film.

[0073] Example 3

[0074] This embodiment provides a traditional Chinese medicine composition, comprising the following components in parts by weight:

[0075] 85 parts of Radix Pseudostellariae, 65 parts of Radix Ophiopogonis, 60 parts of Fructus Schisandrae Chinensis, 65 parts of Rhizoma Polygonati Spermatis, 85 parts of Fructus Corni, 5 parts of Radix Notoginseng, 60 parts of Rhizoma Asteris, 50 parts of Fructus Perillae, 60 parts of Apricot Kernel, 60 parts of Ginkgo, 40 parts of Pheretima, 60 parts of Rhizoma Pinelliae and 30 parts of Radix Glycyrrhizae Preparata.

[0076] This embodiment also provides a tablet for nourishing yin and replenishing qi, and the preparation method thereof is as follows:

[0077] (1) Grind Panax notoginseng into fine powder according to the proportion of the Chinese medicine composition provided in this embodiment and set aside.

[0078] (2) According to the ratio of the Chinese medicine composition provided in this example, 12 herbs including Radix Pseudostellariae, Radix Ophiopogonis, Fructus Schisandrae Chinensis, Radix Polygonati, Fructus Corni, Fructus Asteris, Fructus Perillae, Apricot Kernel, Ginkgo, Pheretima, Rhizoma Pinelliae Rhizoma and Radix Glycyrrhizae were taken, soaked in water for 3 hours, boiled twice, each time for 1.5 hours, filtered and the filtrate was combined;

[0079] (3) The filtrate is centrifuged, the supernatant is taken, and it is concentrated under reduced pressure to a paste with a relative density of 1.05 at 50°C, and then allowed to stand at room temperature. Ethanol is added until the alcohol content reaches 75%, and the mixture is allowed to stand at room temperature for 12 hours. The supernatant is taken, and the ethanol is recovered until there is no alcohol taste, and it is concentrated under reduced pressure to a thick paste with a relative density of 1.10 at 50°C. The paste is mixed with the above-mentioned Panax notoginseng fine powder, and dried under reduced pressure to form a dry extract (water content ≤ 8%), which is crushed and passed through an 80-mesh sieve; appropriate amounts of adhesives, wetting agents, disintegrants, lubricants, etc. are added, mixed evenly, pressed into tablets, and coated with a film.

[0080] Example 4

[0081] This embodiment provides a traditional Chinese medicine composition, comprising the following components in parts by weight:

[0082] 65 parts of Pseudostellariae Radix, 85 parts of Radix Ophiopogonis, 40 parts of Fructus Schisandrae Chinensis, 85 parts of Rhizoma Polygonati Spermatis, 65 parts of Fructus Corni, 35 parts of Radix Notoginseng, 40 parts of Aster, 70 parts of Fructus Perillae, 40 parts of Apricot, 40 parts of Ginkgo, 60 parts of Pheretima, 40 parts of Rhizoma Pinelliae Rhizoma and 50 parts of Radix Glycyrrhizae Preparata.

[0083] This embodiment also provides a tablet for nourishing yin and replenishing qi, and its preparation method is the same as the preparation method described in Example 1.

[0084] Example 5

[0085] This embodiment provides a traditional Chinese medicine composition, comprising the following components in parts by weight:

[0086] 75 parts of Pseudostellariae Radix, 75 parts of Radix Ophiopogonis, 50 parts of Fructus Schisandrae Chinensis, 75 parts of Rhizoma Polygonati, 75 parts of Fructus Corni, 15 parts of Radix Notoginseng, 50 parts of Rhizoma Asteris, 60 parts of Fructus Perillae, 50 parts of Apricot Kernel, 50 parts of Ginkgo, 50 parts of Pheretima, 50 parts of Rhizoma Pinelliae Rhizoma and 40 parts of Radix Glycyrrhizae Preparata.

[0087] This embodiment also provides a tablet for nourishing yin and replenishing qi, and its preparation method is the same as the preparation method described in Example 1.

[0088] Example 6

[0089] This embodiment provides a traditional Chinese medicine composition, comprising the following components in parts by weight:

[0090] 75 parts of Pseudostellariae Radix, 75 parts of Radix Ophiopogonis, 50 parts of Fructus Schisandrae Chinensis, 75 parts of Rhizoma Polygonati, 75 parts of Fructus Corni, 25 parts of Radix Notoginseng, 50 parts of Rhizoma Asteris, 60 parts of Fructus Perillae, 50 parts of Apricot Kernel, 50 parts of Ginkgo, 50 parts of Pheretima, 50 parts of Rhizoma Pinelliae Rhizoma and 40 parts of Radix Glycyrrhizae Preparata.

[0091] This embodiment also provides a tablet for nourishing yin and replenishing qi, and its preparation method is the same as the preparation method described in Example 1.

[0092] Example 7

[0093] This embodiment provides a traditional Chinese medicine composition, comprising the following components in parts by weight:

[0094] 75 parts of Pseudostellariae Radix, 75 parts of Radix Ophiopogonis, 50 parts of Fructus Schisandrae Chinensis, 75 parts of Rhizoma Polygonati, 75 parts of Fructus Corni, 20 parts of Radix Notoginseng, 50 parts of Rhizoma Asteris, 60 parts of Fructus Perillae, 50 parts of Apricot Kernel, 50 parts of Ginkgo, 50 parts of Pheretima, 50 parts of Rhizoma Pinelliae Rhizoma and 40 parts of Radix Glycyrrhizae Preparata.

[0095] This embodiment also provides a tablet for nourishing yin and replenishing qi, and its preparation method is the same as the preparation method described in Example 1.

[0096] Clinical Validation

[0097] In order to investigate the clinical efficacy of the drugs provided by the present invention in treating idiopathic pulmonary fibrosis, patients with IPF who met the Western medicine diagnostic criteria and whose TCM syndrome type was Qi and Yin deficiency were selected from the respiratory outpatient department of a certain hospital to evaluate the therapeutic effect of idiopathic fibrosis; 30 cases were selected in the Western medicine treatment group (control group) and 30 cases in the Chinese medicine treatment group (treatment group).

[0098] 1.1 The cases screened retrospectively are as follows:

[0099] Control group: 30 cases, given conventional western medicine treatment, oral administration of nintedanib ethanesulfonate soft capsules, 150 mg each time, twice a day, for 3 consecutive months to observe the efficacy;

[0100] Treatment group: 30 cases, given Chinese medicine treatment, Yangyin Yiqi prescription, prescription: Pseudostellariae Radix 7.5g, Radix Ophiopogonis 7.5g, Fructus Schisandrae Chinensis 5g, Rhizoma Polygonati 7.5g, Fructus Corni 7.5g, Radix Notoginseng 2g, Radix Asteris 5g, Fructus Perillae 6g, Apricot 5g, Ginkgo 5g, Pheretima 5g, Rhizoma Pinelliae 5g and Radix Glycyrrhizae 4g. The medicine is a Chinese medicine decoction provided by a hospital, 1 dose per day, 1 time in the morning and 1 time in the evening, 1 bag each time, 200mL per bag, warm and take, continuous medication for 3 months to observe the efficacy.

[0101] 1.2 Summary of efficacy observations

[0102] 1) TCM syndrome score: TCM syndrome evaluation was performed according to the quantitative grading standard of Qi and Yin deficiency syndrome in the Guiding Principles for Clinical Research of New Chinese Medicines. The main symptoms (shortness of breath, cough-daytime, cough-nighttime, expectoration) were scored 0, 2, 4, and 6 points respectively according to the severity. The secondary symptoms (dry mouth and throat, chest tightness, fatigue) were scored 0, 1, 2, and 3 points respectively according to the severity. The more severe the symptoms, the higher the score. The TCM symptom scores were recorded before treatment and 3 months after treatment.

[0103] 2) Pulmonary function: forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), peak expiratory flow (PEF), and total lung capacity (TLC) were measured in the control group and the treatment group before and after treatment; the pulmonary function test indicators were statistically recorded before treatment and 3 months after treatment.

[0104] 3) 6-minute walk test: Comparison of 6-minute walk distance; 6-minute walk test before treatment and 3 months after treatment were statistically recorded.

[0105] 1.3. Treatment standards and treatment effects

[0106] 1) TCM syndrome efficacy standard: After 3 months of treatment, the clinical efficacy standard is formulated based on the references and efficacy index:

[0107] Clinical control: clinical symptoms disappear (main and secondary symptoms of TCM syndromes), efficacy index ≥ 90%; markedly effective: clinical symptoms significantly alleviated, 70% ≤ efficacy index < 90%; effective: clinical symptoms significantly alleviated, 30% ≤ efficacy index < 70%; ineffective: clinical symptoms did not improve or worsened, efficacy index < 30%;

[0108] Efficacy index = (TCM syndrome score before treatment - TCM syndrome score after treatment) / TCM syndrome score before treatment × 100%.

[0109] Total effective rate = (clinical control + markedly effective + effective) cases / total cases × 100%, the results are shown in Table 1;

[0110] Table 1

[0111]

[0112] As can be seen from Table 1, the total effective rate of the Chinese medicine composition provided by the present disclosure (treatment group) is 90%, while that of the control group is 70%, and the treatment group is significantly better than the control group.

[0113] Comparison of TCM syndrome (symptom) scores before and after treatment between the control group and the treatment group is shown in Table 2;

[0114] Table 2

[0115]

[0116] As can be seen from Table 2, there was no difference in the TCM syndrome scores (main symptoms and secondary symptoms) before treatment with the Chinese medicine composition provided by the present disclosure, and the TCM syndrome scores (main symptoms and secondary symptoms) after treatment had a better therapeutic effect than the control group.

[0117] 2) Comparison of lung function indicators before and after treatment, the results are shown in Table 3;

[0118] Table 3

[0119]

[0120] As shown in Table 3, there was no difference in FEV1, PEF, FVC and TLC levels between the control group and the treatment group before treatment; after treatment, the levels of FEV1, PEF, FVC and TLC increased compared with those before treatment, and the levels of FEV1, PEF, FVC and TLC in the treatment group after treatment were higher than those in the control group.

[0121] 3) Comparison of 6-minute walking distance before and after treatment, the results are shown in Table 4;

[0122] Table 4

[0123]

[0124] As shown in Table 4, the 6-minute walking test, which reflects the activity tolerance of patients, showed significant improvement in the treatment group after treatment.

[0125] 1.4 Comparison of adverse reactions: diarrhea, nausea and vomiting, abdominal pain, and loss of appetite. The number of cases of adverse reactions after 3 months of treatment was counted, and the results are shown in Table 5.

[0126] Table 5

[0127] Group Diarrhea (case) Nausea and vomiting (example) Abdominal pain (example) Loss of appetite (example) Treatment group (30 cases) 0 3 0 0 Control group (30 cases) 19 6 10 5

[0128] As shown in Table 5, the control group had obvious gastrointestinal adverse reactions such as abdominal pain, diarrhea, nausea and vomiting, and loss of appetite, while the treatment group had only 3 cases of adverse reactions such as nausea and vomiting, and no other adverse reactions.

[0129] It should be noted that, in this article, relational terms such as "first" and "second" are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Moreover, the terms "include", "comprise" or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or device. In the absence of further restrictions, the elements defined by the sentence "comprise a ..." do not exclude the existence of other identical elements in the process, method, article or device including the elements.

[0130] The above description is only a specific embodiment of the present disclosure, so that those skilled in the art can understand or implement the present disclosure. Various modifications to these embodiments will be apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present disclosure. Therefore, the present disclosure will not be limited to the embodiments described herein, but will conform to the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A Chinese medicine composition, characterized in that: The Chinese medicine composition comprises: Radix Pseudostellariae, Radix Ophiopogonis, Fructus Schisandrae Chinensis, Radix Polygonati Sinensis, Fructus Corni, Radix Notoginseng, Radix Asteris, Fructus Perillae, Apricot, Ginkgo, Pheretima, Rhizoma Pinelliae Rhizoma and Radix Glycyrrhizae Preparata.

2. The Chinese medicine composition according to claim 1, characterized in that: The Chinese medicine composition comprises the following components in parts by weight: 55-95 parts of Pseudostellariae Radix, 55-95 parts of Radix Ophiopogonis, 30-70 parts of Schisandrae Chinensis, 55-95 parts of Polygonatum sibiricum, 55-95 parts of Cornus officinalis, 1-40 parts of Panax notoginseng, 30-70 parts of Aster, 40-80 parts of Perilla seeds, 30-70 parts of Apricot, 30-70 parts of Ginkgo, 30-70 parts of Pheretima, 30-70 parts of Pinellia ternata and 20-60 parts of Radix Glycyrrhizae Preparata.

3. The Chinese medicine composition according to claim 1 or 2, characterized in that: The Chinese medicine composition comprises the following components in parts by weight: 65-85 parts of Pseudostellariae Radix, 65-85 parts of Radix Ophiopogonis, 40-60 parts of Schisandrae Chinensis, 65-85 parts of Polygonatum sibiricum, 65-85 parts of Fructus Corni, 5-35 parts of Notoginseng, 40-60 parts of Aster, 50-70 parts of Fructus Perillae, 40-60 parts of Apricot, 40-60 parts of Ginkgo, 40-60 parts of Pheretima, 40-60 parts of Pinellia Rhizoma and 30-50 parts of Radix Glycyrrhizae Preparata.

4. The Chinese medicine composition according to any one of claims 1 to 3, characterized in that The Chinese medicine composition comprises the following components in parts by weight: 75 parts of Pseudostellariae Radix, 75 parts of Radix Ophiopogonis, 50 parts of Fructus Schisandrae Chinensis, 75 parts of Rhizoma Polygonati, 75 parts of Fructus Corni, 15-25 parts of Radix Notoginseng, 50 parts of Rhizoma Asteris, 60 parts of Fructus Perillae, 50 parts of Apricot, 50 parts of Ginkgo, 50 parts of Pheretima, 50 parts of Rhizoma Pinelliae Rhizoma and 40 parts of Radix Glycyrrhizae Preparata.

5. Use of the Chinese medicine composition according to any one of claims 1 to 4 in the preparation of a yin-nourishing and qi-invigorating medicine.

6. A medicinal preparation for nourishing yin and replenishing qi, characterized in that: The pharmaceutical preparation comprises the effective ingredients of the traditional Chinese medicine composition according to any one of claims 1 to 4.

7. The pharmaceutical preparation according to claim 6, characterized in that The pharmaceutical preparation further includes an excipient.

8. The pharmaceutical preparation according to claim 6 or 7, characterized in that The dosage form of the pharmaceutical preparation is tablet, capsule, granule, oral liquid or syrup.

9. A method for preparing a pharmaceutical preparation according to any one of claims 6 to 8, characterized in that: The preparation method comprises the following steps: (1) crushing Panax notoginseng to obtain Panax notoginseng fine powder for later use; (2) soaking Radix Pseudostellariae, Radix Ophiopogonis, Fructus Schisandrae Chinensis, Radix Polygonati Sinensis, Fructus Corni, Fructus Asteris, Fructus Perillae, Apricot Kernel, Ginkgo, Pheretima, Rhizoma Pinelliae and Radix Glycyrrhizae in water for water extraction to obtain a water extract; (3) preparing the dosage form of the pharmaceutical preparation by combining the water extract and the Panax notoginseng fine powder.

10. The preparation method according to claim 9, characterized in that: The soaking time in step (2) is 1-3 hours; Preferably, the water extraction method in step (2) is: decocting at least 2 times, each decocting for 1.5-3 hours; Preferably, preparing the water extract and the notoginseng fine powder into the dosage form of the pharmaceutical preparation comprises the following steps: The water extract is concentrated to a relative density of 1.05-1.20 at 50°C, ethanol is added to an alcohol content of 65-75%, and the mixture is allowed to stand for 12-24 hours. The supernatant is taken, and the ethanol is recovered until there is no alcohol taste, and the supernatant is concentrated to a relative density of 1.10-1.25 at 50°C, and the extract is mixed with the notoginseng fine powder, and dried to a dry extract. The dry extract is post-processed to prepare the dosage form of the pharmaceutical preparation.

Images