Dietetic therapy formula composition for harmonizing five internal organs as well as preparation and application thereof

Abstract

The invention relates to the field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating acute lung injury, which is prepared from the following raw material medicines in parts by weight: 1-5 parts of ginseng, 1-20 parts of medlar, 1-24 parts of almond, 1-20 parts of turmeric, 5-25 parts of dandelion and 1-20 parts of emblic leafflower fruit. The invention further provides a traditional Chinese medicine compound preparation for treating acute lung injury and application.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicines, and in particular, relates to a traditional Chinese medicine composition for treating acute lung injury and a preparation and application thereof. Background Art

[0002] Acute lung injury (ALI) is a serious respiratory disease, which is typically manifested by acute respiratory distress, decreased oxygenation capacity, and damage to the alveolar capillary barrier. According to surveys, the incidence of ALI in intensive care units is about 10% to 15%, and the mortality rate is as high as 40%. Acute lung injury is usually caused by factors such as infection, trauma, or inhalation of harmful gases, and the disease progresses rapidly. Existing treatments are mainly supportive treatments such as mechanical ventilation, but they can only temporarily relieve symptoms and cannot effectively suppress the inflammatory response of the lungs. In addition, although the use of drugs such as glucocorticoids can reduce inflammation in the short term, long-term use will bring serious complications such as immunosuppression and infection, affecting the efficacy and patient prognosis.

[0003] Qingzao Jiufei Decoction is a classic Chinese medicine prescription, first seen in the Synopsis of the Golden Chamber, which has the effects of nourishing yin and moistening dryness, clearing the lungs and relieving cough. In the prescription, mulberry leaves are light, spicy and cool, clearing and venting dryness and heat, clearing the lungs and relieving cough, and are the main medicine. Gypsum is sweet, spicy and very cold, clearing lung heat and producing fluid to quench thirst; Ophiopogon japonicus nourishes yin and produces fluid, and helps mulberry leaves to clear heat and remove dryness, and are the minister medicines. Apricot kernel and loquat leaves descend qi, relieve cough and relieve asthma; donkey-hide gelatin and sesame seeds help Ophiopogon japonicus nourish yin and moisten dryness; ginseng and licorice are intended to replenish the middle qi and cultivate the soil to produce gold, and are the adjuvants. Licorice harmonizes the various medicines and is the guiding medicine. The combination of the various medicines can clear dryness and heat, restore qi and yin, moisten the lung metal, and reduce lung reversal. Modern studies have shown that this prescription can not only improve cough symptoms, but also enhance immune function and alleviate acute lung injury through various channels. Summary of the invention

[0004] The purpose of the present invention is to provide a Chinese medicine composition for treating acute lung injury and its preparation and application.

[0005] The first aspect of the present invention provides a traditional Chinese medicine composition for treating acute lung injury, which is prepared from the following raw materials in parts by weight: 1-60 parts of wax gourd seeds, 1-60 parts of reed roots, 1-20 parts of peach kernels, 1-40 parts of coix seeds, 1-60 parts of purslane, and 1-20 parts of patches of walnuts.

[0006] In a preferred example, the Chinese medicine composition is made of the following raw materials in parts by weight: 20-45 parts of wax gourd seeds, 20-45 parts of reed roots, 5-15 parts of peach kernels, 15-35 parts of coix seeds, 20-45 parts of purslane, and 5-15 parts of patches.

[0007] In a preferred example, the Chinese medicine composition is made of the following raw materials in parts by weight: 1 part of wax gourd seeds, 1 part of reed root, 1 part of peach kernel, 1 part of coix seed, 1 part of purslane, and 1 part of patchouli.

[0008] In another preferred example, the Chinese medicine composition is made of the following raw materials in parts by weight: 15 parts of wax gourd seeds, 15 parts of reed roots, 5 parts of peach kernels, 10 parts of coix seeds, 15 parts of purslane, and 5 parts of patchouli.

[0009] In another preferred example, the Chinese medicine composition is made of the following raw materials in parts by weight: 30 parts of wax gourd seeds, 30 parts of reed roots, 10 parts of peach kernels, 20 parts of coix seeds, 30 parts of purslane, and 9 parts of Patchouli.

[0010] In another preferred example, the Chinese medicine composition is made of the following raw materials in parts by weight: 45 parts of wax gourd seeds, 45 parts of reed roots, 15 parts of peach kernels, 30 parts of coix seeds, 45 parts of purslane, and 15 parts of patches.

[0011] In another preferred example, the Chinese medicine composition is made of the following raw materials in parts by weight: 60 parts of wax gourd seeds, 60 parts of reed roots, 20 parts of peach kernels, 40 parts of coix seeds, 60 parts of purslane, and 20 parts of patches of osmanthus.

[0012] In another preferred example, the Chinese medicine composition is made of the following raw materials in parts by weight: 30 parts of wax gourd seeds, 30 parts of reed roots, 10 parts of peach kernels, 20 parts of coix seeds, 30 parts of purslane, and 9 parts of Patchouli.

[0013] The second aspect of the present invention is to provide a Chinese medicine compound preparation for treating acute lung injury, wherein the Chinese medicine compound preparation is a decoction, granules, powder, capsule, tablet or oral liquid with the above-mentioned Chinese medicine composition as an active ingredient.

[0014] The present invention also provides the use of the above-mentioned traditional Chinese medicine composition in preparing medicine for treating acute lung injury.

[0015] The details of various aspects of the present invention will be described in detail in the following sections. The features, objectives and advantages of the present invention will become more apparent through the following description and the claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Figure 1 This study shows the effect of Anhe Wuzang dietary therapy on the pathological morphology of lung tissue in ALI / ARDS mice

[0017] Figure 2 The results show that Anhe Wuzang dietary therapy can improve the pathological score of lung injury in ALI / ARDS mice

[0018] Figure 3 This study shows that Anhe Wuzang Dietary Recipe has an effect on the mRNA expression of IL-1β, TNF-α, Hif-1α, and PFKFB3 in the lung tissue of ALI / ARDS mice DETAILED DESCRIPTION

[0019] The Chinese medicinal materials used by the inventors in the process of preparing the pharmaceutical composition of the present invention have the following sources: ginseng, the root of Panax ginseng CAMey. [P.schin-seng Nees] of the Araliaceae family. Lycium barbarum, the dried mature fruit of Lycium barbarum L. of the Solanaceae family. Apricot, the dried mature seeds of Prunus armeniaca L. var. ansu Maxim., Prunus sibirica L., Prunus mandshurica (Maxim.) Koehne or Prunus armeniaca L. of the Rosaceae family. Turmeric, the dried rhizome of Curcuma longa L. of the Zingiberaceae family. Dandelion, the whole herb with roots of Taraxacum mongolicum Hand.-Mazz. of the Asteraceae family. Emblica, the dried mature fruit of Phyllanthus Emblica of the Euphorbiaceae family. The inventor, based on many years of clinical practice experience, believes that the pathogenic factors of this disease mainly include invasion of exogenous evil, improper diet, emotional injury, long-term illness due to overwork, etc., but deficiency of healthy qi and imbalance of the five internal organs run through this disease. In traditional Chinese medicine, ALI belongs to the categories of "asthma and dehydration", "chest knot", "violent asthma", etc., and its pathogenesis is that the lung controls the qi mechanism, exogenous evil invades the lung, qi mechanism is stagnant, upward reversal causes asthma, middle obstruction causes fullness, heat forces blood circulation, blood overflows and causes blood stasis outside the veins, blood stasis and heat are mutually bound, stagnate in the lungs, causing the lung to regulate the water channel function to fail, and water fluid is stagnant. The key to the pathogenesis lies in heat, blood stasis, water (wetness), and deficiency. From the theory of traditional Chinese medicine, this side has the effects of invigorating qi, strengthening the body, and harmonizing the five internal organs, which is in line with the "healthy qi inside, evil cannot be done" described in Huangdi Neijing. The Chinese medicine composition of the present invention comprises six Chinese medicines in total. In the side, ginseng greatly replenishes the vital energy, restores the pulse and consolidates dehydration, enters the heart, spleen, lung, and kidney meridians, and is the monarch medicine. Apricot kernels can lower qi, relieve cough and asthma, and enter the lung and large intestine meridians; turmeric can invigorate blood circulation, promote qi, dissipate blood stasis and relieve pain, and enter the liver and spleen meridians; wolfberry can nourish the liver and kidneys, and enter the liver, kidney and lung meridians. The three medicines are all ministerial medicines. Dandelion can clear away heat and detoxify, disperse nodules and reduce swelling, and promote dampness and relieve stranguria. It is combined with apricot kernels to make dampness and heat come out from the stool and urine; Phyllanthus emblica is a commonly used medicine in Tibetan medicine, which has the functions of clearing heat and cooling blood, promoting body fluid and quenching thirst, and is a ministerial medicine. The six medicines in this prescription are all medicinal and edible materials. The four monarch and ministerial medicines in the prescription enter the five internal organs meridians. Except for turmeric, they all enter the lung meridian, which means to harmonize the five internal organs and treat the lungs. The ministerial medicine and the monarch and ministerial medicine are combined to play the effect of invigorating qi, strengthening the body and harmonizing the five internal organs.

[0020] The Chinese medicine composition of the present invention can be prepared according to the conventional method in the art, for example: all the medicinal materials are soaked in water for 0.5 hour to 2 hours, all the medicinal materials are boiled in water over high heat and then slowly boiled over low heat for half an hour; after removing the residue and taking the juice, the same method is continued, and the two decoctions are mixed; during the preparation process, the amount of water added is controlled so that the water surface exceeds the medicinal material surface by 2 to 3 cm.

[0021] The present invention will be further described below in conjunction with specific examples. It should be understood that these examples are only used to illustrate the present invention and are not intended to limit the scope of the present invention. Any method and material similar or equivalent to the described content can be applied to the method of the present invention. The experimental methods for which specific conditions are not specified in the following examples are usually carried out under conventional conditions or under conditions recommended by the manufacturer.

[0022] The above features mentioned in the present invention or the features mentioned in the embodiments can be combined in any way. All the features disclosed in this patent specification can be used in combination with any combination form, and each feature disclosed in the specification can be replaced by any alternative feature that can provide the same, equal or similar purpose. Therefore, unless otherwise specified, the disclosed features are only general examples of equal or similar features.

[0023] The raw materials used in the present invention, such as ginseng, wolfberry, almond, turmeric, dandelion, and emblica, all comply with the relevant provisions of the Chinese Pharmacopoeia 2020 edition, Part I, under the main text of each medicinal material. Each medicinal material has been processed by cleaning, cutting, processing, and crushing. Before feeding, it has been identified that the actual medicinal material is consistent with the name, and the quality meets the national pharmacopoeia standards (the specific medicinal material identification method is implemented in accordance with the pharmacopoeia standards).

[0024] The Chinese medicine composition of the present invention has the effects of invigorating qi, strengthening the body and harmonizing the five internal organs, can effectively improve the symptoms of lung injury, prevent the aggravation of lung injury, can prevent and treat acute lung injury, and has definite efficacy, small side effects and low cost. It is especially suitable for taking during the epidemic season of respiratory viruses and has promotion and application value.

[0025] The present invention will be further described below in conjunction with specific examples. It should be understood that these examples are intended only to illustrate the present invention and are not intended to limit the scope of the present invention. The experimental methods in the following examples without specifying specific conditions are usually performed under normal conditions or according to the conditions recommended by the manufacturer. Unless otherwise stated, all percentages, ratios, proportions, or parts are by weight.

[0026] Unless otherwise defined, all professional and scientific terms used herein have the same meanings as those familiar to those skilled in the art. In addition, any methods and materials similar or equivalent to those described herein can be applied to the methods of the present invention. The preferred implementation methods and materials described herein are for demonstration purposes only.

[0027] The above features mentioned in the present invention or the features mentioned in the embodiments can be combined in any way. All the features disclosed in this patent specification can be used in combination with any combination form, and each feature disclosed in the specification can be replaced by any alternative feature that can provide the same, equal or similar purpose. Therefore, unless otherwise specified, the disclosed features are only general examples of equal or similar features.

[0028] Example 1: Preparation of the Five Zang-organ Anhe Dietary Therapy Recipe

[0029] Weigh 1g of ginseng, 1g of wolfberry, 1g of almond, 1g of turmeric, 5g of dandelion and 1g of emblica fruit, soak all the medicinal materials in water for 0.5 hour, boil all the medicinal materials together over high heat, then simmer over low heat for half an hour; continue this method after removing the residue and taking the juice, mix the two decoctions; during the preparation process, control the amount of water added so that the water surface exceeds the surface of the medicinal materials by 2 to 3 cm.

[0030] Example 2: Preparation of the Five Zang-organ Anhe Dietary Therapy Recipe

[0031] Weigh 2g of ginseng, 5g of wolfberry, 6g of almond, 5g of turmeric, 10g of dandelion and 5g of emblica, soak all the herbs in water for 0.5 hour, boil all the herbs together over high heat and then simmer over low heat for half an hour; remove the residue and take the juice and continue this method, mix the two decoctions; during the preparation process, control the amount of water added so that the water surface exceeds the surface of the herbs by 2 to 3 cm.

[0032] Example 3: Preparation of the Five Zang-organ Anhe Dietary Therapy Recipe

[0033] Weigh 3g of ginseng, 9g of wolfberry, 12g of almond, 9g of turmeric, 15g of dandelion and 10g of emblica, soak all the herbs in water for 1 hour, boil all the herbs together over high heat and then simmer over low heat for half an hour; remove the residue and take the juice and continue this method, mix the two decoctions; during the preparation process, control the amount of water added so that the water surface exceeds the surface of the herbs by 2 to 3 cm.

[0034] Example 4: Preparation of the Five Zang-organ Anhe Dietary Therapy Recipe

[0035] Weigh 4g of ginseng, 15g of wolfberry, 18g of almond, 15g of turmeric, 20g of dandelion and 15g of emblica, soak all the herbs in water for 1 hour, boil all the herbs together over high heat and then simmer over low heat for half an hour; continue this method after removing the residue and taking the juice, mix the two decoctions; during the preparation process, control the amount of water added so that the water surface exceeds the surface of the herbs by 2 to 3 cm.

[0036] Example 5: Preparation of the Five Zang-organ Anhe Dietary Therapy Recipe

[0037] Weigh 5g of ginseng, 20g of wolfberry, 24g of almond, 20g of turmeric, 25g of dandelion and 20g of emblica, soak all the herbs in water for 1 hour, boil all the herbs together over high heat and then simmer over low heat for half an hour; remove the residue and take the juice and continue this method, mix the two decoctions; during the preparation process, control the amount of water added so that the water surface exceeds the surface of the herbs by 2 to 3 cm.

[0038] Example 6: Preparation of the Five Zang-Anhe Dietary Therapy Recipe

[0039] Weigh 3g of ginseng, 9g of wolfberry, 12g of almond, 9g of turmeric, 15g of dandelion and 10g of emblica, soak all the herbs in water for 1.5 hours, boil all the herbs together over high heat and then simmer over low heat for half an hour; continue this method after removing the residue and taking the juice, mix the two decoctions; during the preparation process, control the amount of water added so that the water surface exceeds the surface of the herbs by 2 to 3 cm.

[0040] Example 7: Pharmaceutical research on the Anhe Wuzang dietary therapy recipe

[0041] 7.1 Animals:

[0042] 60 healthy male C57BL / 6 mice, SPF grade, body weight (20-22) g, Shanghai SLACK Experimental Animal Co., Ltd., certificate number: 20220004035589, special standard pellet feed, water feeding, animal ethics review number: PZSHUTCM2310260004, the experiment was conducted in the Experimental Animal Center facilities of Shanghai University of Traditional Chinese Medicine (SYCK (Shanghai) 2020-0009).

[0043] 7.2 Main equipment and instruments:

[0044] Low-temperature refrigerated centrifuge 3K15 (Sigma, USA); ELISA reader 680 (Bio-Rad, USA); real-time fluorescence quantitative PCR instrument (QuantSTudio3, USA); PCR instrument (Mastercycler nexus, Germany); SDS-PAGE electrophoresis instrument (MINIProtean2 Bio-Rad, USA); pathology section machine (Shanghai Leica Instrument Co., Ltd., China).

[0045] 7.3 Drugs and reagents:

[0046] Dexamethasone tablets, Tianjin Xinyi Jinjin Pharmaceutical Co., Ltd., batch number 501220321; lipopolysaccharide, Sigma-aldrich, batch number 0000153963; RNA extraction kit (B0004D, EZBioscience, Suzhou, China); reverse transcription kit (TakaRa, China, catalog number: RR036A); qPCR kit (Novozyme, China, catalog number: Q711-02); primer sequences (Sangon Biotechnology Co., Ltd., China).

[0047] The Anhe Wuzang Dietary Therapeutic Recipe prepared in Example 3 was reheated and concentrated to 76.9 ml, i.e., a concentration of 0.754 g / ml, and then cooled and stored at 4°C for later use.

[0048] 7.4 Statistical methods:

[0049] All data were analyzed using SPSS 29.0 statistical software. All experiments were repeated 3 times or more, and the data were After the variance homogeneity test, one-way analysis of variance was used for data from more than two groups, and the independent sample t test was used for the difference between two groups. P < 0.05 indicated statistical significance.

[0050] 7.5 Observation of general condition of mice:

[0051] Experimental methods:

[0052] Sixty healthy male SPF C57BL / 6 mice were randomly divided into a normal group, a model group, an Anhe Wuzang diet therapy group (high and low doses) and a dexamethasone group, with 10 mice in each group; they weighed (20-22) g and were housed in an SPF barrier environment with 12-h light-dark alternation, (24±2)℃, and a relative humidity of (55±5)%. They were allowed to eat and drink freely. After one week of adaptive feeding, the Anhe Wuzang diet therapy group (high, medium, and low doses) was given 0.2 ml of the corresponding concentration of Anhe Wuzang diet therapy (high dose 30.16 g / kg, medium dose 15.08 g / kg, and low dose 7.54 g / kg) once a day; the dexamethasone group was given 0.2 ml of dexamethasone (5 mg / kg) by intragastric gavage; the normal group and the model group were given 0.2 ml of normal saline by intragastric gavage once a day. On the 7th day of intragastric gavage, 20 mg\kg of LPS was injected intraperitoneally to establish the model. The mice in the model group, Anhe Wuzang diet therapy prescription (high, medium and low doses) group and dexamethasone group were all given LPS intraperitoneal injection to establish the model. The normal group was given saline intraperitoneal injection. During the experiment, the mental state, activity, fur glossiness, and death of all mice were observed. Mice were disposed of 24 hours after modeling, and blood was collected to separate serum for serological testing. The right lobe of the lung was fixed in 4% paraformaldehyde, dehydrated according to gradient ethanol, embedded in paraffin, and sliced ​​for lung tissue pathological morphology detection. The remaining lungs were quickly frozen in liquid nitrogen and stored in a -80°C refrigerator for later use.

[0053] Experimental results:

[0054] After intraperitoneal injection of LPS, mice in the model group showed obvious symptoms of qi and yin deficiency, including curling up, mental depression, slow reaction, significantly reduced activity, decreased appetite and water intake, dry and dull fur, accompanied by hair loss and dry stool. In contrast, mice in the normal group showed a good mental state, lively and active, quick reaction, normal eating, and smooth fur. After intragastric administration, the response of mice in the Anhe Wuzang diet therapy group and the dexamethasone group to LPS was significantly weakened, and the symptoms of qi and yin deficiency were alleviated to varying degrees. These results show that the Anhe Wuzang diet therapy and dexamethasone have a certain therapeutic effect in improving the physiological state of mice.

[0055] 7.6 Observation on the inhibitory effect of Chinese herbal medicine combination on dyspnea in mice

[0056] Experimental methods:

[0057] Two experimental technicians observed the dyspnea symptoms of the mice and heard obvious dry or wet rales or sputum sounds without using a stethoscope. The onset time was recorded and the average of the two records was taken.

[0058] Experimental results:

[0059] Table 1 shows the inhibitory effect of the Chinese medicine composition on dyspnea in mice; all mice in the model group had dyspnea. Compared with the model group, the dyspnea time in the high, medium and low dose groups of the Chinese medicine composition was significantly reduced (P<0.01), and there was no significant difference in dyspnea time between the high dose group and the dexamethasone group (P>0.05). This shows that the Chinese medicine composition alleviated the dyspnea symptoms, and the degree of relief in the high dose group was similar to that of the Western medicine dexamethasone.

[0060] Table 1 Comparison of the onset time of dyspnea in each group of mice

[0061]

[0062]

[0063] Note: Compared with the model group, * indicates: P < 0.05, ** indicates: P < 0.01; compared with the dexamethasone group: △ indicates: P < 0.05, △△ indicates: P < 0.01

[0064] 7.7 Observation of mouse lung tissue pathology

[0065] Experimental methods:

[0066] Fresh lung tissue of mice was taken and fixed in 4% paraformaldehyde. Paraffin sections were routinely dehydrated, the procedure was: 75% ethanol 2h → 85% ethanol 2h → 90% ethanol 2h → 100% ethanol 45min → 100% ethanol 45min → ethanol + xylene (1:1) 10min → xylene 8min → xylene 8min → paraffin 1h → paraffin 1h → paraffin 1h. Paraffin was routinely embedded. The wax block was placed on a -20℃ freezer, and after cooling, it was clamped on the paraffin slicer stand, cut into 4-6 microns, and the slices were placed on the water surface of the slide machine (water temperature 40℃), and the tissue slices were picked up with a slide, and baked in a 60℃ oven for 1 hour for use. Paraffin sections were dewaxed to water, the procedure was: xylene I 20min → xylene II 20min → anhydrous ethanol I 5min → anhydrous ethanol II 5min → 75% alcohol 5min gradient dewaxing → water washing. Slices were stained with hematoxylin for 3-5 minutes, excess stain was washed off with tap water, differentiated with 1% hydrochloric acid aqueous solution for a few seconds, rinsed with tap water, then blued with 0.6%-0.7% ammonia aqueous solution, and rinsed with running water for a few seconds. Paraffin sections were dehydrated with gradient alcohol (85% ethanol → 95% ethanol) and stained with eosin stain for 5 minutes. Paraffin sections were sequentially placed in anhydrous ethanol I for 5 minutes → anhydrous ethanol II for 5 minutes → anhydrous ethanol III for 5 minutes → n-butanol for 5 minutes → xylene I for 5 minutes → xylene II for 5 minutes until transparent, and the sections were taken out of xylene to dry slightly, and sealed with neutral gum. The sections were observed under an optical microscope and the images were saved.

[0067] Experimental results:

[0068] HE staining observation of mouse lung tissue

[0069] Figure 1 This study shows the effect of Anhe Wuzang dietary therapy on the pathological morphology of lung tissue in ALI / ARDS mice. Figure 1 It can be seen that the alveolar structure of the lung tissue in the normal group was clear, the alveoli were uniform in size, the airway mucosal epithelial structure was intact, and no obvious pathological changes were observed; the lung tissue structure of the mice in the model group was disordered, a large number of red blood cells were seen in the alveolar cavity and interstitium, and flake blood foci were visible to the naked eye. The alveolar wall was significantly thickened, and a transparent membrane of the alveolar wall was formed. Some bronchial epithelial cells fell off, and there was infiltration of neutrophils and lymphocytes. The above pathological changes in each group of the Anhe Wuzang Diet Therapy Recipe were alleviated.

[0070] 7.8 Pathological scoring of mouse lung tissue injury

[0071] Experimental methods:

[0072] Lung tissue sections were scored, and the scoring criteria were 0 to 4 points according to the degree of localized pulmonary necrosis, neutrophil and erythrocyte infiltration, alveolar septum thickening, alveolar cavity enlargement, and pulmonary hyaline membrane formation: no damage was 0 points, lesion range <25% was 1 point, lesion range 25% to 50% was 2 points; lesion range 51% to 75% was 3 points, and lesion range >75% was 4 points. Ten high-power microscopic fields were scored for each section.

[0073] result:

[0074] Figure 2 This shows the effect of Anhe Wuzang Dietary Therapy on the pathological score of lung injury in ALI / ARDS mice; in the figure, compared with the normal group, #: P<0.05, ##: P<0.01, ###: P<0.001; compared with the model group, *: P<0.05, **: P<0.01, ***: P<0.001; Figure 2 It can be seen that compared with the normal group, the lung injury pathological score of mice in the model group was significantly increased (P<0.001). Compared with the model group, the lung injury scores of mice in the high, medium and low dose groups of Anhe Wuzang Diet Therapy Recipe were significantly reduced (P<0.05, P<0.001).

[0075] 7.9 Determination of mRNA expression of IL-1β, TNF-α, Hif-1α, and PFKFB3 in mouse lung tissue Experimental method:

[0076] RNA was extracted from fresh lung tissue using an RNA extraction kit and then reverse transcribed into cDNA. The primer sequences are shown in Table 1. TM 3 lines were subjected to real-time quantitative PCR. The data were analyzed by relative quantitative method, with β-actin as internal reference, 2 -△△Ct The relative expression of mRNA was determined.

[0077] Table 1 Primer sequences

[0078]

[0079] Experimental results:

[0080] Figure 3 This shows that Anhe Wuzang Dietary Recipe has an effect on the mRNA expression of IL-1β, TNF-α, Hif-1α, and PFKFB3 in the lung tissue of ALI / ARDS mice; in the figure, compared with the normal group, #: P<0.05, ##: P<0.01, ###: P<0.001; compared with the model group, *: P<0.05, **: P<0.01, ***: P<0.001; Figure 3It can be seen that compared with the normal group, the mRNA expression of IL-1β, TNF-α, Hif-1α, and PFKFB3 in the lung tissue of mice in the model group was significantly increased (P<0.001). Compared with the model group, the mRNA expression of IL-1β, TNF-α, Hif-1α, HK2, and PFKFB3 in the lung tissue of mice in the high, medium, and low dose groups of Anhe Wuzang Diet Therapy Recipe was significantly decreased (P<0.05, P<0.01).

[0081] Example 8 Comparative Study of Chinese Medicine Composition and Literature Prescription

[0082] Experimental Animals:

[0083] Thirty-two healthy male C57BL / 6 mice, SPF grade, body weight (20-22) g, Shanghai SLACK Experimental Animal Co., Ltd., certificate number: 20220004035589, special standard pellet feed, water feeding, animal ethics review number: PZSHUTCM2310260004, the experiment was conducted in the Experimental Animal Center facilities of Shanghai University of Traditional Chinese Medicine (SYCK (Shanghai) 2020-0009).

[0084] Experimental drugs:

[0085] The Chinese medicine composition was prepared according to Example 3

[0086] Literature:

[0087] 10g mulberry leaf, 15g gypsum, 10g almond, 10g raw licorice, 10g ophiopogon, 3g ginseng, 10g donkey-hide gelatin, 10g fried sesame seed, 10g roasted loquat leaf. Soak the raw herbs in a casserole with appropriate amount of water for 30 minutes, boil over high heat until boiling, and concentrate over low heat. References ([1] Wang Jing, Yi Xuanhong, Wang Ping, et al. Analysis of the preventive effect of Tanreqing injection combined with Qingzao Jiufei decoction on radiation-induced lung injury [J / OL]. Liaoning Journal of Traditional Chinese Medicine, 1-6 [2024-10-29]. http: / / kns.cnki.net / kcms / detail / 21.1128.R.20240522.0951.006.html. [2] Shen Weisheng, Xia Dehong, Xi Lei, et al. Study on the intervention effect of Qingzao Jiufei decoction on radiation-induced lung injury and its effect on cell growth factors - CTGF and PDGF [J]. Chinese Journal of Experimental Traditional Chinese Medicine, 2009, 15(11):95-98. DOI:10.13422 / j.cnki.syfjx.2009.11.041.)

[0088] Experimental methods:

[0089] Mice were randomly divided into a normal group, a model group, a Chinese medicine composition group, and a literature prescription group. There were 10 mice in each group. After one week of adaptive feeding, the Chinese medicine composition group and the literature prescription group were given Chinese medicine composition and literature prescription by gavage, respectively, once a day; the normal group and the model group were gavaged with an equal volume of normal saline, once a day. On the 7th day of gavage, 20 mg\kg of LPS was injected intraperitoneally to establish the model. Mice in the model group, the Chinese medicine composition group, and the literature prescription group were all given LPS intraperitoneal injection to establish the model. The normal group was given an intraperitoneal injection of normal saline. During the experiment, all mice were observed for symptoms of dyspnea, and the onset time was recorded. Mice were disposed of 24 hours after modeling, and blood was collected to separate serum for serological detection. IL-1β, TNF-α, and Hif-1α levels were detected according to the instructions of the ELISA kit.

[0090] Statistical methods:

[0091] All data were analyzed using SPSS 29.0 statistical software. After the variance homogeneity test, one-way analysis of variance was used for data from more than two groups. P < 0.05 indicated statistical significance.

[0092] Experimental results:

[0093] Table 3 shows that the Chinese medicine combination has a better inhibitory effect on dyspnea in mice than the literature prescription; all mice in the model group developed dyspnea. As shown in Table 3, compared with the model group, the dyspnea time in the Chinese medicine combination group was significantly reduced (P<0.01), and the inhibitory effect on dyspnea was better than that in the literature prescription group (P<0.01).

[0094] Table 3 Comparison of the onset time of dyspnea in each group of mice

[0095]

[0096] Note: Compared with the model group, * means: P < 0.05, ** means: P < 0.01; compared with the literature: △ means: P < 0.05, △△ means: P < 0.01

[0097] Table 4 shows the effect of the Chinese medicine combination on inflammatory factors and hypoxia-inducible factors in mice; as shown in Table 4, compared with the normal group, the expression of inflammatory factors IL-1β, IL-6 and hypoxia-inducible factor Hif-1α in the model group mice was significantly increased (P<0.01). The Chinese medicine combination group had a better inhibitory effect on the expression of inflammatory factors and hypoxia-inducible factors in mice than the literature group (P<0.01).

[0098] Table 4 Levels of inflammatory factors and hypoxia-inducible factors in mouse serum ( pg / ml)

[0099]

[0100] Note: Compared with the normal group, # means: P < 0.05, ## means: P < 0.01; compared with the model group, * means: P < 0.05, ** means: P < 0.01; compared with the literature: △ means: P < 0.05, △△ means: P < 0.01

[0101] Example 9 Comparative study of Chinese medicine combination and separated prescriptions

[0102] Experimental Animals:

[0103] 96 healthy male C57BL / 6 mice, SPF grade, body weight (20-22) g, Shanghai SLACK Experimental Animal Co., Ltd., certificate number: 20220004035589, special standard pellet feed, water feeding, animal ethics review number: PZSHUTCM2310260004, the experiment was conducted in the experimental animal center of Shanghai University of Traditional Chinese Medicine (SYCK (Shanghai) 2020-0009). Experimental drugs:

[0104] The Chinese medicine composition was prepared according to Example 3

[0105] The drug composition of separated prescription 1: 9g of wolfberry, 12g of almond, 9g of turmeric, 15g of dandelion, and 10g of emblica. The drug composition of separated prescription 2: 3g of ginseng, 12g of almond, 9g of turmeric, 15g of dandelion, and 10g of emblica. The drug composition of separated prescription 3: 3g of ginseng, 9g of wolfberry, 9g of turmeric, 15g of dandelion, and 10g of emblica. The drug composition of separated prescription 4: 3g of ginseng, 9g of wolfberry, 12g of almond, 15g of dandelion, and 10g of emblica. The drug composition of separated prescription 5: 3g of ginseng, 9g of wolfberry, 12g of almond, 9g of turmeric, and 10g of emblica. The drug composition of separated prescription 6: 3g of ginseng, 9g of wolfberry, 12g of almond, 9g of turmeric, and 15g of dandelion. Preparation method of the separated prescription drugs: prepared according to the method of Example 3.

[0106] Experimental methods:

[0107] Mice were randomly divided into a normal group, a model group, a Chinese medicine combination group, and a disassembled prescription group (disassembled prescription 1, disassembled prescription 2, disassembled prescription 3, disassembled prescription 4, disassembled prescription 5, and disassembled prescription 6). There were 10 mice in each group. After one week of adaptive feeding, the Chinese medicine combination group and the literature prescription group were given Chinese medicine combination and disassembled prescription by gavage once a day, respectively; the normal group and the model group were gavaged with equal volumes of normal saline once a day. On the 7th day of gavage, 20 mg / kg of LPS was injected intraperitoneally to establish the model. Mice in the model group, the Chinese medicine combination group, and the disassembled prescription group were all given LPS intraperitoneal injection to establish the model. The normal group was given an intraperitoneal injection of normal saline. During the experiment, all mice were observed for symptoms of dyspnea, and the onset time was recorded. Mice were disposed of 24 hours after modeling, and blood was collected to separate serum for serological detection. IL-1β, TNF-α, and Hif-1α levels were detected according to the instructions of the ELISA kit.

[0108] Statistical methods:

[0109] All data were analyzed using SPSS 29.0 statistical software. After the variance homogeneity test, one-way analysis of variance was used for data from more than two groups. P < 0.05 indicated statistical significance.

[0110] Experimental results:

[0111] Table 5 shows that the inhibitory effect of the Chinese medicine combination on the symptoms of dyspnea, inflammatory factors, and hypoxia-inducible factors in mice is better than that of each decomposed prescription group; all mice in the model group had dyspnea. As can be seen from Table 5, compared with the model group, the dyspnea time of the Chinese medicine combination and each decomposed prescription group was significantly reduced (P<0.01), but the therapeutic effect of any decomposed prescription with one less medicine was not as good as that of the Chinese medicine combination, and there was a statistical difference (P<0.01). Compared with the normal group, the serum inflammatory factor IL-1β and hypoxia-inducible factor Hif-1α of mice in the model group were significantly increased (P<0.01). Compared with the model group, the inflammatory factors IL-1β and hypoxia-inducible factor Hif-1α in the serum of the Chinese medicine combination and each decomposed prescription group were significantly reduced (P<0.01), but the therapeutic effect of any decomposed prescription with one less medicine was not as good as that of the Chinese medicine combination, and there was a statistical difference (P<0.01).

[0112] Table 5 Comparison of dyspnea onset time, inflammatory factors and hypoxia-inducible factors in mice of each group

[0113]

[0114] Note: Compared with the normal group, # means: P < 0.05, ## means: P < 0.01; compared with the model group, * means: P < 0.05, ** means: P < 0.01;

[0115] Example 10 Comparative study of treatment with Chinese medicine combination and conventional western medicine alone

[0116] Study subjects

[0117] The patient went to the TCM Internal Medicine Clinic of Shuguang Hospital and was diagnosed with acute lung injury. He was in the recovery period and was also diagnosed with Qi and Yin deficiency by TCM diagnosis.

[0118] Western medicine diagnostic criteria:

[0119] The diagnostic criteria for acute lung injury (ALI) refer to the 2012 Berlin Definition (Acute respiratory distress syndrome: the Berlin Definition): lung imaging changes, PaO2 / FiO2≤300mmHg, and excluding pulmonary edema caused by heart failure and fluid overload. The onset time is within the past month.

[0120] TCM diagnostic criteria:

[0121] Refer to the chapter "Asthma" in the "Tenth Edition of the National TCM Colleges and Universities Planning Textbook for Internal Medicine". The main clinical manifestations are shortness of breath when moving, dyspnea, general fatigue, opening the mouth and raising the shoulders, twitching of the nostrils, inability to lie flat, tired expression, spontaneous sweating or night sweats, low fever, hot hands and feet, poor appetite, dry mouth and tongue, and red tongue with little coating. Inclusion criteria: (1) 18 years old ≤ age ≥ 80 years old; (2) meet the above-mentioned Western medicine and TCM diagnostic criteria; (3) the patient and his family agree and are willing to sign the informed consent form.

[0122] Exclusion criteria:

[0123] (1) Patients who are not in recovery or are in critical condition. (2) Patients with other serious systemic diseases, heart failure, severe liver and kidney dysfunction, etc. (3) Patients with abnormal consciousness or mental illness. (4) Patients with allergic constitution.

[0124] Research Methodology:

[0125] Patients in the recovery period of acute lung injury, and at the same time, TCM syndrome differentiation is Qi and Yin deficiency. A total of 60 cases were randomly divided into a Chinese medicine group and a control group, with 30 cases in each group. Conventional Western medicine treatment of acute lung injury refers to the "Guidelines for the Diagnosis and Treatment of Acute Lung Injury / Acute Respiratory Distress Syndrome (2006)". The control group was given conventional Western medicine treatment (including oxygen therapy, antibiotics, glucocorticoids, fluid management, etc.). The Chinese medicine group was treated with a Chinese medicine composition (3g ginseng, 9g wolfberry, 12g almond, 9g turmeric, 15g dandelion, 10g emblica) on the basis of conventional Western medicine treatment. The preparation method is the same as Example 3, 1 dose per day, orally after meals, 7 days as a course of treatment. The efficacy was observed after 7 treatments.

[0126] Efficacy criteria:

[0127] According to the TCM syndrome scoring scale of the "Clinical Disease Diagnosis Based on Cure and Improvement Standards" and the "Guidelines for Clinical Research of New Chinese Medicines", the scores of patients before and after medication were recorded. Calculation formula: efficacy rate = (total score before treatment - total score after treatment) / total score before treatment × 100. Cured: The patient has no obvious shortness of breath and fatigue when moving, and the oxygenation index is >300mHg; the TCM syndrome score is reduced by ≥90%; markedly effective: The patient has only slight shortness of breath and no obvious fatigue; 60%≤ TCM syndrome score reduction <90%; progress: The patient's shortness of breath when moving is relieved compared with before, but some symptoms still exist, 30%≤ TCM syndrome score reduction <60%; ineffective: The patient's shortness of breath and panting are roughly the same as before, but the relief is not obvious, there are often interruptions or obvious panting when speaking, and there are still symptoms such as mental fatigue, general fatigue, dry mouth, spontaneous sweating and night sweats; TCM syndrome score reduction <30%. Total effective rate = cure rate + markedly effective rate + improvement rate.

[0128] Observation of inflammation indicators:

[0129] The neutrophil ratio (NEUT%) and C-reactive protein (CRP) in the blood of the two groups of patients were detected at 7 days of treatment. Safety monitoring:

[0130] Observe the patient for any adverse reactions such as allergic reactions, diarrhea, vomiting, dizziness, etc.

[0131] Statistical analysis:

[0132] All data were processed using SPSS 29.0 statistical software. After the variance homogeneity test, the independent sample t test was used for the comparison between the groups before and after treatment, and the one-way analysis of variance was used for the comparison within the same group. The count data were expressed as the number of cases (%), and the categorical count data were expressed using Pearson χ 2 P<0.05 was considered statistically significant.

[0133] Research findings:

[0134] The general information of the patients was collected, and there was no significant difference in age, gender, and smoking history, and the two groups of patients were comparable. Table 6 shows the efficacy of the Chinese medicine composition on acute lung injury. The total effective rate of the Chinese medicine group can reach 96.7%, and the efficacy of the Chinese medicine group is better than that of the control group, and the difference is statistically significant (P<0.01). It shows that the Chinese medicine composition significantly relieves the symptoms of patients, and the total effective rate of combined treatment with the Chinese medicine composition is better than that of conventional Western medicine alone. Table 7 shows the effect of the Chinese medicine composition on inflammatory indicators in patients with acute lung injury. Compared with the control group, the neutrophil ratio and C-reactive protein of the Chinese medicine group were significantly reduced (P<0.01). It shows that the Chinese medicine composition can reduce inflammation in patients. Through safety monitoring, no adverse reactions occurred in the Chinese medicine group. It shows that the Chinese medicine composition has good safety, definite clinical efficacy, and important clinical value for acute lung injury.

[0135] Table 6 Comparison of the efficacy of Chinese medicine combination on acute lung injury

[0136]

[0137] Table 7 Comparison of inflammatory indicators between the two groups of patients

[0138]

[0139]

[0140] Note: Compared with before treatment, # means: P < 0.05, ## means: P < 0.01; compared with the control group after treatment, * means: P < 0.05, ** means: P < 0.01;

[0141] The various aspects of the present invention have been described above. However, it should be understood that, without departing from the spirit of the present invention, equivalent changes and modifications may be made by those skilled in the art, and the changes and modifications also fall within the scope of the appended claims of the present application.

Claims

1. A Chinese medicine composition for treating acute lung injury, characterized in that: The invention is prepared from the following raw materials in parts by weight: 1-5 parts of ginseng, 1-20 parts of wolfberry, 1-24 parts of almond, 1-20 parts of turmeric, 5-25 parts of dandelion and 1-20 parts of emblica.

2. The Chinese medicine composition according to claim 1, characterized in that The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 2-4 parts of ginseng, 5-15 parts of wolfberry, 6-18 parts of almond, 5-15 parts of turmeric, 10-20 parts of dandelion and 5-15 parts of emblica.

3. The Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 1 part of ginseng, 1 part of wolfberry, 1 part of almond, 1 part of turmeric, 5 parts of dandelion and 1 part of emblica.

4. The Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 2 parts of ginseng, 5 parts of wolfberry, 6 parts of almond, 5 parts of turmeric, 10 parts of dandelion and 5 parts of emblica.

5. The Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 3 parts of ginseng, 9 parts of wolfberry, 12 parts of almond, 9 parts of turmeric, 15 parts of dandelion and 10 parts of emblica.

6. The Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 4 parts of ginseng, 15 parts of wolfberry, 18 parts of almond, 15 parts of turmeric, 20 parts of dandelion and 15 parts of emblica.

7. The Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 5 parts of ginseng, 20 parts of wolfberry, 24 parts of almond, 20 parts of turmeric, 25 parts of dandelion and 20 parts of emblica.

8. The Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 3 parts of ginseng, 9 parts of wolfberry, 12 parts of almond, 9 parts of turmeric, 15 parts of dandelion and 10 parts of emblica.

9. A Chinese medicinal compound preparation for treating acute lung injury, characterized in that: The Chinese medicine compound preparation is a decoction, granule, powder, capsule, tablet or oral liquid with the Chinese medicine composition described in claim 1 or 2 or 3 or 4 or 5 or 6 or 7 or 8 as the active ingredient.

10. Use of the Chinese medicine composition as claimed in claim 1 or 2 or 3 or 4 or 5 or 6 or 7 or 8 in the preparation of a medicament for treating acute lung injury.

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