CN113616742B - Traditional Chinese medicine composition for treating lung and spleen deficiency of pulmonary diseases and preparation method and application thereof - Google Patents
Traditional Chinese medicine composition for treating lung and spleen deficiency of pulmonary diseases and preparation method and application thereof Download PDFInfo
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Abstract
The invention provides a traditional Chinese medicine composition for treating lung and spleen deficiency caused by pulmonary diseases, which is characterized by comprising the following components in parts by weight: 1-100 parts of codonopsis pilosula, 1-100 parts of astragalus membranaceus, 1-100 parts of bighead atractylodes rhizome, 1-100 parts of poria cocos, 1-100 parts of prepared pinellia ternate, 1-100 parts of dried orange peel, 1-100 parts of walnut kernel, 1-100 parts of Chinese yam, 1-100 parts of inula flower, 1-100 parts of rhizoma cyperi, 1-100 parts of madder, 1-100 parts of cortex albiziae, 1-100 parts of rice sprout and 1-100 parts of honey-fried licorice root. The clinical application proves that the traditional Chinese medicine composition can effectively treat patients with lung and spleen deficiency caused by pulmonary diseases.
Description
Technical Field
The invention relates to the technical field of traditional Chinese medicines, and in particular relates to a traditional Chinese medicine composition for treating lung and spleen deficiency caused by pulmonary diseases, and a preparation method and application thereof.
Background
According to the traditional Chinese medicine, the spleen is in the relation of earth, the lung is in the relation of metal and the spleen and the lung are in the relation of mother and child, mother disease can reach child disease, child disease steals mother qi, and two zang organs are affected mutually to cause the same disease. The pulmonary diseases can cause the symptoms of lung and spleen deficiency, and the symptoms are as follows: debilitation, shortness of breath, low voice, poor appetite, sallow complexion, etc.
For patients with lung and spleen deficiency, although the discharge condition is achieved through treatment, some patients still have the problems of lung injury, lung function reduction, immune injury and the like to different degrees, so that the symptoms of lung and spleen deficiency such as fatigue, anorexia, hoarseness, short breath and the like are presented. In some patients who are discharged from hospital, the patients are infected with nucleic acid again and turn positive due to low immune function. At present, a targeted scheme for effective popularization and application proved by evidence-based medicine is not available.
Disclosure of Invention
The invention aims to provide a traditional Chinese medicine composition for treating or preventing lung and spleen deficiency of pulmonary diseases for clinical use, which is characterized by comprising the following components in parts by weight: 1-100 parts of codonopsis pilosula, 1-100 parts of astragalus membranaceus, 1-100 parts of bighead atractylodes rhizome, 1-100 parts of poria cocos, 1-100 parts of prepared pinellia ternate, 1-100 parts of dried orange peel, 1-100 parts of walnut kernel, 1-100 parts of Chinese yam, 1-100 parts of inula flower, 1-100 parts of rhizoma cyperi, 1-100 parts of madder, 1-100 parts of cortex albiziae, 1-100 parts of rice sprout and 1-100 parts of honey-fried licorice root. The composition of the present invention may be directly ground into powder, or may be an extract prepared by a conventional method in the art, etc. The traditional Chinese medicine used in the composition of the present invention can also be used by directly grinding into powder, extract or other processing forms.
Further, the traditional Chinese medicine composition comprises: 1-50 parts of codonopsis pilosula, 1-50 parts of astragalus membranaceus, 1-25 parts of bighead atractylodes rhizome, 1-25 parts of poria cocos, 1-25 parts of prepared pinellia ternate, 1-15 parts of dried orange peel, 1-40 parts of walnut kernel, 1-40 parts of Chinese yam, 1-15 parts of inula flower, 1-15 parts of rhizoma cyperi, 1-15 parts of madder, 1-25 parts of cortex albiziae, 1-40 parts of rice sprout and 1-15 parts of honey-fried licorice root.
Further, the traditional Chinese medicine composition comprises: 20-50 parts of codonopsis pilosula, 20-50 parts of astragalus membranaceus, 10-25 parts of bighead atractylodes rhizome, 10-25 parts of poria cocos, 10-25 parts of prepared pinellia ternate, 5-15 parts of dried orange peel, 10-40 parts of walnut kernel, 10-40 parts of Chinese yam, 5-15 parts of inula flower, 5-15 parts of rhizoma cyperi, 5-15 parts of madder, 10-25 parts of cortex albiziae, 10-40 parts of rice sprout and 5-15 parts of honey-fried licorice root.
Further, the traditional Chinese medicine composition comprises: 40 parts of codonopsis pilosula, 40 parts of astragalus membranaceus, 20 parts of bighead atractylodes rhizome, 20 parts of poria cocos, 20 parts of prepared pinellia ternate, 12 parts of pericarpium citri reticulatae, 30 parts of walnut kernels, 30 parts of Chinese yam, 12 parts of inula flower, 12 parts of rhizoma cyperi, 10 parts of madder, 20 parts of cortex albiziae, 30 parts of rice sprouts and 10 parts of honey-fried licorice roots.
Wherein the radix Codonopsis, Atractylodis rhizoma and rhizoma Cyperi are crude or processed product respectively, such as parched radix Codonopsis, parched Atractylodis rhizoma and Vinegar rhizoma Cyperi respectively; the rhizoma Pinelliae Preparata is rhizoma Pinelliae Preparata, rhizoma Pinelliae Preparada or rhizoma Pinelliae Preparada.
The invention also provides application of the traditional Chinese medicine composition in preparing a medicine for treating lung and spleen deficiency caused by pulmonary diseases. The lung and spleen deficiency of the pulmonary diseases can be used for treating pulmonary and spleen deficiency symptoms of the pulmonary diseases, and is not limited to various types of stages such as light type, common type, heavy type, dangerous and heavy type, convalescent stage and the like.
Further, the pulmonary disease may be selected from the group consisting of a novel coronavirus pneumonia (COVID-19), a community-acquired pneumonia, an influenza, or a common cold.
The invention also provides a medicine for treating lung and spleen deficiency caused by pulmonary diseases, which is characterized by being prepared from any one of the traditional Chinese medicine compositions and pharmaceutically acceptable auxiliary materials or additives.
Specifically, the medicine can be selected from decoction, granule, capsule, tablet, pill, oral liquid, tincture, syrup, medicated tea, spray, inhalation preparation, aerosol, mixture, and injection.
The invention also provides a preparation method of any one of the traditional Chinese medicine compositions, which is characterized in that the traditional Chinese medicine composition can be prepared according to any one of the following preparation methods:
a. taking radix Codonopsis, radix astragali, Atractylodis rhizoma, Poria, rhizoma Pinelliae Preparada, pericarpium Citri Tangerinae, semen Juglandis, rhizoma Dioscoreae, flos Inulae, rhizoma Cyperi, radix Rubiae, cortex Albizziae, fructus oryzae, and radix Glycyrrhizae Preparata; adding 8 times of water, reflux-extracting for 2 times, each for 1.5 hr, mixing extractive solutions, and concentrating under reduced pressure to obtain water extract; or the like, or, alternatively,
b. taking radix codonopsitis, radix astragali, rhizoma atractylodis macrocephalae, poria cocos, processed pinellia ternate, pericarpium citri reticulatae, walnut kernel, Chinese yam, inula flower, rhizoma cyperi, madder, cortex albiziae, rice sprout and honey-fried licorice root, adding 8 times of water for 2 times, extracting for 1.5 hours each time, combining extracting solutions, concentrating to obtain a water extract, adding ethanol, quickly and slowly stirring until the ethanol content is 60%, standing, absorbing the upper layer, and recovering ethanol under reduced pressure to obtain a water extract and ethanol precipitate; or the like, or, alternatively,
c. soaking radix Codonopsis, radix astragali, Atractylodis rhizoma, Poria, rhizoma Pinelliae Preparada, pericarpium Citri Tangerinae, semen Juglandis, rhizoma Dioscoreae, Inulae flos, rhizoma Cyperi, radix Rubiae, cortex Albizziae, fructus oryzae, and radix Glycyrrhizae Preparata in 8 times of water for 2 times (1.5 hr each time), mixing extractive solutions, and concentrating to obtain extract; or the like, or, alternatively,
d. extracting radix Codonopsis, radix astragali, Atractylodis rhizoma, Poria, rhizoma Pinelliae Preparada, pericarpium Citri Tangerinae, semen Juglandis, rhizoma Dioscoreae, Inulae flos, rhizoma Cyperi, radix Rubiae, cortex Albizziae, fructus oryzae, and radix Glycyrrhizae Preparata with 8 times of ethanol under reflux for 2 times (1.5 hr each time), mixing extractive solutions, and concentrating to obtain extract; or the like, or, alternatively,
e. taking radix codonopsitis, radix astragali, rhizoma atractylodis macrocephalae, tuckahoe, processed pinellia ternate, dried orange peel, walnut kernel, yam, inula flower, rhizoma cyperi, madder, cortex albiziae, rice sprout and honey-fried licorice root, respectively adding 8 times of water for 2 times, and extracting for 1.5 hours each time, combining extracting solutions, concentrating to obtain radix codonopsitis extract, radix astragali extract, rhizoma atractylodis macrocephalae extract, tuckahoe extract, processed pinellia ternate extract, dried orange peel extract, walnut kernel extract, yam extract, inula flower extract, rhizoma cyperi extract, madder extract, cortex albiziae extract, rice sprout extract and honey-fried licorice root extract, and mixing the extracts.
The invention also provides a preparation method of the medicine for treating lung and spleen deficiency caused by pulmonary diseases, which is characterized in that the medicine is selected from granules, and the preparation method can be prepared according to any one of the following methods:
taking radix codonopsitis, radix astragali, rhizoma atractylodis macrocephalae, poria cocos, processed pinellia ternate, pericarpium citri reticulatae, walnut kernel, Chinese yam, inula flower, rhizoma cyperi, madder, cortex albiziae, rice sprout and honey-fried licorice root, adding 8-12 times of water for extracting for 1-3 hours, filtering, adding 6-10 times of water for reflux extraction for 1-2 hours, combining extracting solutions, concentrating under reduced pressure to obtain an extract, drying, crushing to obtain a middle body composition, adding auxiliary materials, and granulating to obtain the traditional Chinese medicine composition;
taking radix codonopsitis, astragalus, bighead atractylodes rhizome, poria cocos, processed pinellia ternate, dried orange peel, walnut kernel, Chinese yam, inula flower, rhizoma cyperi, madder, cortex albiziae, rice sprout and honey-fried licorice root, adding 8-12 times of water to extract for 1-3 hours, filtering, adding 6-10 times of water to extract for 1-3 hours, combining extracting solutions, concentrating under reduced pressure to obtain an extract, adding ethanol, slowly stirring at a high speed, precipitating with ethanol, standing, absorbing an upper layer, recovering ethanol under reduced pressure to obtain a water-extracting ethanol-precipitating extract, drying, crushing to obtain an intermediate composition, adding auxiliary materials, and granulating to obtain the Chinese medicinal composition;
taking radix codonopsitis, radix astragali, rhizoma atractylodis macrocephalae, poria cocos, processed pinellia ternate, pericarpium citri reticulatae, walnut kernel, Chinese yam, inula flower, rhizoma cyperi, madder, cortex albiziae, rice sprout and honey-fried licorice root, adding 8-12 times of water, warm-soaking and extracting for 1-3 hours, filtering, adding 6-10 times of water, warm-soaking and extracting for 1-3 hours, combining extracting solutions, concentrating under reduced pressure to obtain an extract, drying, crushing to obtain an intermediate composition, adding auxiliary materials, and granulating to obtain the traditional Chinese medicine composition;
taking radix codonopsitis, radix astragali, rhizoma atractylodis macrocephalae, poria cocos, processed pinellia ternate, pericarpium citri reticulatae, walnut kernel, Chinese yam, inula flower, rhizoma cyperi, madder, cortex albiziae, rice sprout and honey-fried licorice root, adding 8-12 times of ethanol with certain concentration, performing reflux extraction for 0.5-2 hours, filtering, adding 6-10 times of ethanol with certain concentration, performing reflux extraction for 0.5-2 hours, combining extracting solutions, performing reduced pressure concentration to obtain an extract, drying and crushing to obtain an intermediate composition, adding auxiliary materials, and granulating to obtain the intermediate composition;
taking radix codonopsitis, radix astragali, rhizoma atractylodis macrocephalae, poria cocos, processed pinellia ternate, pericarpium citri reticulatae, walnut kernel, Chinese yam, inula flower, rhizoma cyperi, madder, cortex albiziae, rice sprout and radix glycyrrhizae preparata, respectively adding 8-12 times of water for 0.5-2 hours, filtering, then adding 6-10 times of water for 0.5-2 hours, merging extracting solutions, concentrating under reduced pressure to obtain radix codonopsitis extract, radix astragali extract, rhizoma atractylodis macrocephalae extract, poria cocos extract, processed pinellia ternate extract, pericarpium citri reticulatae extract, walnut kernel extract, Chinese yam extract, inula flower extract, rhizoma cyperi extract, madder extract, cortex albiziae extract, rice sprout extract and radix glycyrrhizae preparata extract, respectively drying and crushing to obtain intermediates with medicinal flavors, mixing to obtain a composition, adding auxiliary materials, and granulating to obtain the traditional Chinese medicine composition.
In the preparation process, the extract can be subjected to spray drying, reduced pressure drying and belt drying to obtain an intermediate, and the preparation is subjected to preparation of granules by adopting pharmaceutically acceptable auxiliary materials and preparation modes; the extract can also be mixed with auxiliary materials to prepare soft materials and then granulated, and can also be granulated by adopting a one-step granulation mode, wherein the auxiliary materials and the preparation mode which are all pharmaceutically acceptable are adopted.
Plain questions, five opera treatises are that "excess qi restricts the restriction of qi over restriction and counter-restriction over restriction; if they are not enough, the body fluid will not be over-restricted, but over-restricted, and over-restricted, but light. From the perspective of the generation and restriction of five elements, when the lung and spleen are deficient, the lung has insufficient gold, the heart fire takes over, and the water and the body return; when spleen earth is deficient, liver wood will be dominant and gold qi will come back. The codonopsis pilosula and the astragalus root can tonify middle-jiao and qi, invigorate spleen and benefit lung, and take the mutual effect of gold and soil, and are monarch drugs together, so that the soil can generate gold, and the gold can help the soil, so that the biochemistry is infinite; the lung-qi-strengthening capsule can prevent liver wood from invading spleen soil, and can restrain water and treat lung-qi deficiency and water recovery; the white atractylodes rhizome has the effects of tonifying spleen and qi, eliminating dampness and promoting diuresis, the Chinese yam has the effects of tonifying lung and spleen, and can enhance the strength of tonifying lung and spleen, and the walnut kernel has the effects of tonifying kidney and warming lung, and absorbing qi and relieving asthma, and is used as a ministerial drug; the prepared pinellia tuber eliminates dampness and phlegm, the dried orange peel regulates qi and strengthens spleen, and the rice sprout strengthens spleen and appetizes so as to ensure that the nourishment is not stagnated; the tuckahoe, the cortex albiziae, the melancholy-relieving and nerve-soothing effects can prevent the heart fire and the disturbance due to the lung-metal deficiency, and the rhizoma cyperi, the melancholy-relieving and nerve-soothing effects can also relieve the possible anxiety condition of a patient; inulae flos and radix Rubiae are main drugs of liver decoction from jin Kui Yao L ü e, and have effects of descending qi, resolving hard mass, promoting blood circulation and regulating collaterals, and are used as adjuvant drugs; to make the prepared licorice root take the effect of harmonizing the other drugs. The whole formula mainly tonifies qi of lung and spleen, calms heart, relieves depression and collaterals, is in good compliance with the principle of five elements of restraining and restraining, and is very suitable for patients with lung system diseases with lung and spleen deficiency.
Detailed Description
As mentioned above, the present invention aims to provide a traditional Chinese medicine composition for lung system diseases with lung and spleen deficiency, and a preparation method and an application thereof. The following will specifically describe the contents of the experimental examples.
It is specifically noted that similar alternatives and modifications will be apparent to those skilled in the art, which are also intended to be included within the present invention. It will be apparent to those skilled in the art that modifications or appropriate variations and combinations of the methods and applications described herein can be made to implement and use the present technology without departing from the spirit, scope, and content of the present invention. It is to be understood that the described embodiments are merely exemplary of the invention, and not restrictive of the full scope of the invention.
If the specific conditions are not indicated, the method is carried out according to the conventional conditions or the conditions suggested by manufacturers, and the used raw material medicines or auxiliary materials and the used reagents or instruments are the conventional products which can be obtained commercially.
EXAMPLE 1 Compound granule of Chinese medicine
The formula is as follows: 40 parts of codonopsis pilosula, 40 parts of astragalus membranaceus, 20 parts of bighead atractylodes rhizome, 20 parts of poria cocos, 20 parts of prepared pinellia ternate, 12 parts of pericarpium citri reticulatae, 30 parts of walnut kernels, 30 parts of Chinese yam, 12 parts of inula flowers, 12 parts of rhizoma cyperi, 10 parts of madder, 20 parts of cortex albiziae, 30 parts of rice sprouts and 10 parts of honey-fried licorice roots. Wherein the radix Codonopsis, Atractylodis rhizoma, rhizoma Cyperi, and rhizoma Pinelliae Preparada are radix Codonopsis Preparata, Atractylodis rhizoma Preparata, rhizoma Cyperi processed with vinegar, and rhizoma Pinelliae Preparata respectively.
The preparation method of the Chinese medicinal composition granules can be selected from any one of the following methods a, b, c, d and e:
a. taking radix codonopsitis, radix astragali, rhizoma atractylodis macrocephalae, tuckahoe, prepared pinellia ternate, dried orange peel, walnut kernel, yam, inula flower, rhizoma cyperi, madder, cortex albiziae, rice sprout and honey-fried licorice root, adding 8 times of water for extracting for 1.5 hours, filtering, adding 6 times of water for extracting for 1.5 hours, combining extracting solutions, concentrating under reduced pressure to obtain an extract, drying, crushing to obtain a intermediate composition, adding auxiliary materials, and granulating to obtain the traditional Chinese medicine composition.
b. Taking radix codonopsitis, radix astragali, rhizoma atractylodis macrocephalae, poria cocos, processed pinellia ternate, pericarpium citri reticulatae, walnut kernel, Chinese yam, inula flower, rhizoma cyperi, madder, cortex albiziae, rice sprout and radix glycyrrhizae preparata, adding 8 times of water for extracting for 1.5 hours, filtering, adding 8 times of water for extracting for 1.5 hours, combining extracting solutions, concentrating under reduced pressure to obtain an extract, adding ethanol, stirring slowly and quickly, precipitating with ethanol, standing, absorbing the upper layer, recovering the ethanol under reduced pressure to obtain a water extraction and ethanol precipitation extract, drying, crushing to obtain an intermediate composition, adding auxiliary materials, and granulating to obtain the traditional Chinese medicine composition.
c. Taking radix codonopsitis, radix astragali, rhizoma atractylodis macrocephalae, tuckahoe, processed pinellia ternate, dried orange peel, walnut kernel, yam, inula flower, rhizoma cyperi, madder, cortex albiziae, rice sprout and honey-fried licorice root, adding 8 times of water, warm-soaking and extracting for 1.5 hours, filtering, adding 6 times of water, warm-soaking and extracting for 1.5 hours, combining extracting solutions, concentrating under reduced pressure to obtain an extract, drying, crushing to obtain an intermediate composition, adding auxiliary materials, and granulating to obtain the traditional Chinese medicine composition.
d. Taking radix codonopsitis, radix astragali, rhizoma atractylodis macrocephalae, poria cocos, processed pinellia ternate, pericarpium citri reticulatae, walnut kernel, Chinese yam, inula flower, rhizoma cyperi, madder, cortex albiziae, rice sprout and radix glycyrrhizae preparata, adding 8-12 times of ethanol with certain concentration, performing reflux extraction for 1.5 hours, filtering, adding 8 times of ethanol with certain concentration, performing reflux extraction for 1.5 hours, combining extracting solutions, performing reduced pressure concentration to obtain an extract, drying, crushing to obtain an intermediate composition, adding auxiliary materials, and granulating to obtain the traditional Chinese medicine composition.
e. Taking radix codonopsitis, radix astragali, rhizoma atractylodis macrocephalae, poria cocos, processed pinellia ternate, pericarpium citri reticulatae, walnut kernel, Chinese yam, inula flower, rhizoma cyperi, madder, cortex albiziae, rice sprout and honey-fried licorice root, respectively adding 8 times of water for extracting for 1.5 hours, filtering, then adding 8 times of water for extracting for 1.5 hours, merging extracting solutions, concentrating under reduced pressure to obtain radix codonopsitis extract, radix astragali extract, rhizoma atractylodis macrocephalae extract, poria cocos extract, processed pinellia ternate extract, pericarpium citri reticulatae extract, walnut kernel extract, Chinese yam extract, inula flower extract, rhizoma cyperi extract, madder extract, cortex albiziae extract, rice sprout extract and honey-fried licorice root extract, respectively drying and crushing to obtain intermediates of respective medicinal flavors, mixing to obtain a composition, adding auxiliary materials and granulating to obtain the composition.
EXAMPLE 2 Compound Chinese medicinal Capsule
The formula is as follows: 40 parts of codonopsis pilosula, 40 parts of astragalus membranaceus, 20 parts of bighead atractylodes rhizome, 20 parts of poria cocos, 20 parts of prepared pinellia ternate, 12 parts of pericarpium citri reticulatae, 30 parts of walnut kernels, 30 parts of Chinese yam, 12 parts of inula flowers, 12 parts of rhizoma cyperi, 10 parts of madder, 20 parts of cortex albiziae, 30 parts of rice sprouts and 10 parts of honey-fried licorice roots.
The preparation method of the Chinese medicinal composition capsule can be selected from any one of a, b, c, d and e in the following methods:
a. taking codonopsis pilosula, astragalus, bighead atractylodes rhizome, poria cocos, processed pinellia ternate, dried orange peel, walnut kernel, Chinese yam, inula flower, rhizoma cyperi, madder, cortex albiziae, rice sprout and honey-fried licorice root, adding 8 times of water for extracting for 1.5 hours, filtering, adding 8 times of water for extracting for 1.5 hours, combining extracting solutions, concentrating under reduced pressure to obtain an extract, drying, crushing to obtain a middle body composition, adding auxiliary materials, granulating and filling to obtain the traditional Chinese medicine composition.
b. Taking radix codonopsitis, astragalus, white atractylodes rhizome, tuckahoe, prepared pinellia tuber, dried orange peel, walnut kernel, Chinese yam, inula flower, nutgrass galingale rhizome, India madder root, silktree albizzia bark, rice sprout and prepared liquorice, adding 8 times of water for extracting for 1.5 hours, filtering, adding 8 times of water for extracting for 1.5 hours, merging extracting solutions, concentrating under reduced pressure to obtain an extract, adding ethanol, stirring slowly and quickly, precipitating with ethanol, standing, absorbing the upper layer, recovering the ethanol under reduced pressure to obtain an extract of water extraction and ethanol precipitation, drying, crushing to obtain an intermediate composition, adding auxiliary materials, granulating and filling to obtain the Chinese medicinal composition.
c. Taking radix codonopsitis, radix astragali, rhizoma atractylodis macrocephalae, tuckahoe, processed pinellia ternate, dried orange peel, walnut kernel, yam, inula flower, rhizoma cyperi, madder, cortex albiziae, rice sprout and honey-fried licorice root, adding 8 times of water, warm-soaking and extracting for 1.5 hours, filtering, adding 8 times of water, warm-soaking and extracting for 1.5 hours, combining extracting solutions, concentrating under reduced pressure to obtain an extract, drying, crushing to obtain an intermediate composition, adding auxiliary materials, granulating and filling to obtain the traditional Chinese medicine composition.
d. Taking radix codonopsitis, radix astragali, rhizoma atractylodis macrocephalae, poria cocos, processed pinellia ternate, pericarpium citri reticulatae, walnut kernel, Chinese yam, inula flower, rhizoma cyperi, madder, cortex albiziae, rice sprout and honey-fried licorice root, adding 8 times of ethanol with certain concentration, extracting for 1.5 hours under reflux, filtering, adding 8 times of ethanol with certain concentration, extracting for 1.5 hours under reflux, combining extracting solutions, concentrating under reduced pressure to obtain an extract, drying, crushing to obtain an intermediate composition, adding auxiliary materials, granulating and filling to obtain the traditional Chinese medicine composition.
e. Taking radix codonopsitis, radix astragali, rhizoma atractylodis macrocephalae, poria cocos, processed pinellia ternate, pericarpium citri reticulatae, walnut kernel, Chinese yam, inula flower, rhizoma cyperi, madder, cortex albiziae, rice sprout and honey-fried licorice root, respectively adding 8 times of water for extracting for 1.5 hours, filtering, then adding 8 times of water for extracting for 1.5 hours, merging extracting solutions, concentrating under reduced pressure to obtain radix codonopsitis extract, radix astragali extract, rhizoma atractylodis macrocephalae extract, poria cocos extract, processed pinellia ternate extract, pericarpium citri reticulatae extract, walnut kernel extract, Chinese yam extract, inula flower extract, rhizoma cyperi extract, madder extract, cortex albiziae extract, rice sprout extract and honey-fried licorice root extract, respectively drying and crushing to obtain intermediates of respective medicinal flavors, mixing to obtain a composition, adding auxiliary materials, granulating and filling to obtain the composition.
EXAMPLE 3 Compound Chinese medicinal tablet
The formula is as follows: 40 parts of codonopsis pilosula, 40 parts of astragalus membranaceus, 20 parts of bighead atractylodes rhizome, 20 parts of poria cocos, 20 parts of prepared pinellia ternate, 12 parts of pericarpium citri reticulatae, 30 parts of walnut kernels, 30 parts of Chinese yam, 12 parts of inula flowers, 12 parts of rhizoma cyperi, 10 parts of madder, 20 parts of cortex albiziae, 30 parts of rice sprouts and 10 parts of honey-fried licorice roots.
The preparation method of the Chinese medicinal composition tablet can be selected from any one of a, b, c, d and e in the following methods:
a. taking radix codonopsitis, radix astragali, rhizoma atractylodis macrocephalae, tuckahoe, prepared pinellia ternate, dried orange peel, walnut kernel, yam, inula flower, rhizoma cyperi, madder, cortex albiziae, rice sprout and honey-fried licorice root, adding 8 times of water for extracting for 1.5 hours, filtering, adding 8 times of water for extracting for 1.5 hours, combining extracting solutions, concentrating under reduced pressure to obtain an extract, drying, crushing to obtain a intermediate composition, adding auxiliary materials, granulating and tabletting to obtain the traditional Chinese medicine composition.
b. Taking radix codonopsitis, radix astragali, rhizoma atractylodis macrocephalae, poria cocos, processed pinellia ternate, pericarpium citri reticulatae, walnut kernel, Chinese yam, inula flower, rhizoma cyperi, madder, cortex albiziae, rice sprout and honey-fried licorice root, adding 8 times of water for extracting for 1.5 hours, filtering, adding 8 times of water for extracting for 1.5 hours, combining extracting solutions, concentrating under reduced pressure to obtain an extract, adding ethanol, stirring quickly and slowly, precipitating with ethanol, standing, absorbing the upper layer, recovering the ethanol under reduced pressure to obtain a water-extracting ethanol-precipitating extract, drying, crushing to obtain an intermediate composition, adding auxiliary materials, granulating and tabletting to obtain the intermediate composition.
c. Taking radix codonopsitis, radix astragali, rhizoma atractylodis macrocephalae, tuckahoe, processed pinellia ternate, dried orange peel, walnut kernel, yam, inula flower, rhizoma cyperi, madder, cortex albiziae, rice sprout and honey-fried licorice root, adding 8 times of water, warm-soaking and extracting for 1.5 hours, filtering, adding 8 times of water, warm-soaking and extracting for 1.5 hours, combining extracting solutions, concentrating under reduced pressure to obtain an extract, drying, crushing to obtain an intermediate composition, adding auxiliary materials, granulating and tabletting to obtain the traditional Chinese medicine composition.
d. Taking radix codonopsitis, radix astragali, rhizoma atractylodis macrocephalae, poria cocos, processed pinellia ternate, pericarpium citri reticulatae, walnut kernel, Chinese yam, inula flower, rhizoma cyperi, madder, cortex albiziae, rice sprout and radix glycyrrhizae preparata, adding 8 times of ethanol with certain concentration, performing reflux extraction for 1.5 hours, filtering, adding 8 times of ethanol with certain concentration, performing reflux extraction for 1.5 hours, combining extracting solutions, performing reduced pressure concentration to obtain extractum, respectively drying and crushing to obtain intermediates of respective medicinal flavors, mixing to obtain a composition, adding auxiliary materials, granulating and tabletting to obtain the composition.
e. Taking radix codonopsitis, radix astragali, rhizoma atractylodis macrocephalae, poria cocos, processed pinellia ternate, pericarpium citri reticulatae, walnut kernel, Chinese yam, inula flower, rhizoma cyperi, madder, cortex albiziae, rice sprout and radix glycyrrhizae preparata, respectively adding 8 times of water for extracting for 1.5 hours, filtering, then adding 8 times of water for extracting for 1.5 hours, combining extracting solutions, decompressing and concentrating to obtain radix codonopsitis extract, radix astragali extract, rhizoma atractylodis macrocephalae extract, poria cocos extract, processed pinellia ternate extract, pericarpium citri reticulatae extract, walnut kernel extract, Chinese yam extract, inula flower extract, rhizoma cyperi extract, madder extract, cortex albiziae extract, rice sprout extract and radix glycyrrhizae preparata extract, drying and crushing to obtain an intermediate composition, adding auxiliary materials, granulating and tabletting to obtain the traditional Chinese medicine composition.
EXAMPLE 4 Compound oral liquid of Chinese medicine
The formula is as follows: 40 parts of codonopsis pilosula, 40 parts of astragalus membranaceus, 20 parts of bighead atractylodes rhizome, 20 parts of poria cocos, 20 parts of prepared pinellia ternate, 12 parts of pericarpium citri reticulatae, 30 parts of walnut kernels, 30 parts of Chinese yam, 12 parts of inula flowers, 12 parts of rhizoma cyperi, 10 parts of madder, 20 parts of cortex albiziae, 30 parts of rice sprouts and 10 parts of honey-fried licorice roots.
The preparation method of the Chinese medicinal composition oral liquid can be selected from any one of a, b, c, d and e in the following methods:
a. taking radix codonopsitis, radix astragali, rhizoma atractylodis macrocephalae, tuckahoe, processed pinellia ternate, dried orange peel, walnut kernel, yam, inula flower, rhizoma cyperi, madder, cortex albiziae, rice sprout and honey-fried licorice root, adding 8 times of water for extracting for 1.5 hours, filtering, adding 8 times of water for extracting for 1.5 hours, combining extracting solutions, concentrating under reduced pressure to obtain an extract, drying and crushing to obtain an intermediate composition, and preparing the oral liquid through the preparation processes of liquid preparation, taste modification, filling, sterilization and the like.
b. Taking radix codonopsitis, astragalus, atractylodes, tuckahoe, processed pinellia, dried orange peel, walnut kernel, yam, inula flower, rhizoma cyperi, madder, cortex albiziae, rice sprout and honey-fried licorice root, adding 8 times of water for extracting for 1.5 hours, filtering, adding 8 times of water for extracting for 1.5 hours, merging extracting solutions, concentrating under reduced pressure to obtain an extract, adding ethanol, stirring quickly and slowly, precipitating with ethanol, standing, absorbing the upper layer, recovering the ethanol under reduced pressure to obtain a water-extracting and alcohol-precipitating extract, drying, crushing to obtain an intermediate composition, and preparing the oral liquid by liquid preparation, taste modification, filling, sterilization and the like.
c. Taking radix codonopsitis, radix astragali, rhizoma atractylodis macrocephalae, tuckahoe, processed pinellia ternate, dried orange peel, walnut kernel, yam, inula flower, rhizoma cyperi, madder, cortex albiziae, rice sprout and honey-fried licorice root, adding 8 times of water, warm-soaking and extracting for 1.5 hours, filtering, adding 8 times of water, warm-soaking and extracting for 1.5 hours, combining extracting solutions, concentrating under reduced pressure to obtain an extract, drying, crushing to obtain an intermediate composition, and preparing the oral liquid through the processes of liquid preparation, taste modification, filling, sterilization and the like.
d. Taking radix codonopsitis, radix astragali, rhizoma atractylodis macrocephalae, poria cocos, processed pinellia ternate, pericarpium citri reticulatae, walnut kernel, Chinese yam, inula flower, rhizoma cyperi, madder, cortex albiziae, rice sprout and honey-fried licorice root, adding 8 times of ethanol with certain concentration, extracting for 1.5 hours under reflux, filtering, adding 8 times of ethanol with certain concentration, extracting for 1.5 hours under reflux, combining extracting solutions, concentrating under reduced pressure to obtain an extract, drying and crushing to obtain an intermediate composition, and preparing the oral liquid through liquid preparation, taste correction, filling, sterilization and the like.
e. Taking radix codonopsitis, radix astragali, rhizoma atractylodis macrocephalae, poria cocos, processed pinellia ternate, pericarpium citri reticulatae, walnut kernel, Chinese yam, inula flower, rhizoma cyperi, madder, cortex albiziae, rice sprout and honey-fried licorice root, respectively adding 8 times of water for extracting for 1.5 hours, filtering, then adding 8 times of water for extracting for 1.5 hours, merging extracting solutions, concentrating under reduced pressure to obtain radix codonopsitis extract, radix astragali extract, rhizoma atractylodis macrocephalae extract, poria cocos extract, processed pinellia ternate extract, pericarpium citri reticulatae extract, walnut kernel extract, Chinese yam extract, inula flower extract, rhizoma cyperi extract, madder extract, cortex albiziae extract, rice sprout extract and honey-fried licorice root extract, respectively drying and crushing to obtain intermediates of respective medicinal flavors, mixing to obtain a composition, and preparing the oral liquid through liquid preparation, flavor correction, filling, sterilization and the like.
Example 5 Chinese medicinal Compound decoction
The formula is as follows: 40 parts of codonopsis pilosula, 40 parts of astragalus membranaceus, 20 parts of bighead atractylodes rhizome, 20 parts of poria cocos, 20 parts of prepared pinellia ternate, 12 parts of pericarpium citri reticulatae, 30 parts of walnut kernels, 30 parts of Chinese yam, 12 parts of inula flowers, 12 parts of rhizoma cyperi, 10 parts of madder, 20 parts of cortex albiziae, 30 parts of rice sprouts and 10 parts of honey-fried licorice roots.
The preparation method of the Chinese medicinal composition decoction comprises the following steps:
adding 8 times of water into codonopsis pilosula, astragalus, bighead atractylodes rhizome, poria cocos, processed pinellia ternate, dried orange peel, walnut kernel, Chinese yam, inula flower, rhizoma cyperi, madder, cortex albiziae, rice sprout and honey-fried licorice root, decocting for 1.5 hours, filtering, adding 8 times of water, decocting for 1.5 hours, and mixing extracting solutions to obtain the traditional Chinese medicine composition.
The decoction can be taken directly or after being properly collected.
Example 6 clinical trial
1. Clinical data
1.1 general data
The patients in the recovery period of the unit, such as the department of Huaian city traditional Chinese medicine, Yangzhou city traditional Chinese medicine, Zhenjiang city infectious disease hospital and the like, are from 2 months to 3 months in 2020, and the number of the patients is 120 in total. On the basis of fully meeting the requirements of real world research and statistical principle, the treatment groups are divided into 89 cases and 31 cases, and the curative effect of the treatment groups is evaluated by comparing symptom integrals. Considering the specificity of the patients with COVID-19 in treatment management isolation, the treatment group 89 is divided into 50 cases in the treatment group A and 39 cases in the treatment group B, and only 50 cases in the treatment group A and 31 cases in the control group are subjected to objective index detection such as immunology for objective reasons so as to judge the immunological change condition before and after treatment of the treatment group. The general data of the patients in the treatment group, treatment group a and treatment group b before the administration of the drug were compared with those in the control group, and there was no statistical difference (P ═ 0.05), as shown in table 1.
TABLE 1 comparison of general data for patients in the treatment and control groups
1.2.1 Western diagnostic standards refer to the relevant diagnostic standards of COVID-19 in diagnosis and treatment of pneumonia infected with novel coronavirus (trial sixth edition).
1.2.2 Chinese medicine diagnosis Standard the diagnosis Standard of "Lung-spleen deficiency syndrome" was made on the basis of "pneumonia diagnosis and treatment plan for novel coronavirus infection (trial run sixth edition)," Lung-spleen Qi deficiency syndrome "in" Chinese medicine diagnostics "and" Lung-spleen Qi deficiency syndrome "in" internal medicine of traditional Chinese medicine ". The main symptoms are: asthenia, short breath, low voice, poor appetite, sallow complexion; the secondary symptoms are as follows: easy sweating, susceptibility to common cold, aversion to wind, poor spirit, abdominal discomfort and loose stool; tongue pulse: a pale tongue with thin and greasy coating and a thready pulse. The lung and spleen deficiency can be diagnosed according to 5 main symptoms, 4 main symptoms and 4 secondary symptoms, or 4 main symptoms and 3 secondary symptoms and the pulse of tongue coating.
1.3 inclusion criteria
Meeting the diagnosis standards of the Chinese and Western medicine; ② the age is 18-65 years old; and thirdly, signing informed consent and volunteering subjects.
1.4 exclusion and shedding criteria
The exclusion criteria are those patients with COVID-19 who do not reach the discharge criteria; those not in the convalescent period; those with severe primary heart, liver, kidney, blood or disease affecting their survival; psychiatric, cognitive-restricted patients and legally prescribed handicapped; pregnant or lactating women; those who are known to be allergic to the drug used in this test; patients within 1 month or who are participating in other drug clinical trials. The shedding criteria are patient syndrome change, self withdrawal, poor compliance, incomplete data, patient missed visits and other reasons that do not meet the conditions of the study.
2. Method of producing a composite material
2.1 methods of treatment
The granules prepared in the embodiment 1 of the invention are taken in a first group (including a second group) of treatment, each bag contains 10g of the granules, the content of the raw medicines is 38.25g, the granules are taken in 2 bags respectively in the morning and evening, and the granules are taken with warm boiled water, and the treatment course is 14 days. The control group used no other intervention except for the normal diet. Establishing a group patient WeChat group, closely following all patients, and immediately processing according to a COVID-19 diagnosis and treatment scheme if any condition appears in the course of the disease and recording the condition faithfully.
2.2 Observation index
2.2.1 Observation index of curative effect (1) the judgment standard of the curative effect of the syndrome of traditional Chinese medicine is formulated according to the guiding principle of clinical research of new traditional Chinese medicine, and the classification and quantification of the symptom of the lung-spleen deficiency syndrome are shown in Table 2. The main symptoms are 0, 2, 4 and 6 points of none, light, medium and heavy; the secondary symptoms are 0, 1, 2 and 3 points respectively; the tongue and pulse are normally counted as 0 point and the abnormal one as 2 points. The disease grading is that 0 is normal, the mild disease is less than 25 points, the moderate disease is more than or equal to 25 points and less than or equal to 50 points, and the severe disease is more than 50 points, and the judgment standard of the traditional Chinese medicine syndrome curative effect is shown in the table 3. Before and after treatment, symptom integrals are recorded respectively, and the total effective rate is the cure rate + the significant efficiency + the effective rate.
(2) The laboratory examination comprises detection of immunological indexes such as humoral immunity and T lymphocyte subpopulation, and detection and recording are respectively carried out before and after treatment.
TABLE 2 hierarchical quantization table for symptom of lung-spleen deficiency syndrome
TABLE 3 Standard Table for determining the curative effects of the syndromes of traditional Chinese medicine
Note: the curative effect index (n) is (total integral of symptom before treatment-total integral of symptom after treatment)/total integral of symptom before treatment x 100%.
2.2.2 safety observation indexes (general items include body temperature, respiration, heart rate, blood pressure and the like); secondly, the safety detection comprises liver function (alanine aminotransferase ALT and aspartate aminotransferase AST), kidney function (urea nitrogen BUN and creatinine Scr), electrocardiogram and the like; and recording adverse reactions in the medicine taking process faithfully.
2.3 statistical methods
Statistical analysis is performed by using SPSS23.0 software to measure data
Expressing by adopting independent sample t test; the counting data are expressed in percentage by adopting chi2And (6) checking. The statistical difference is represented by P < 0.05.
3. Results
3.1 comparison of clinical efficacy of the treatment groups with that of the control group
3.1.1 symptom score comparison results are shown in Table 4. The group A and the group B have no statistical difference (P is more than 0.05) compared before treatment, and the group 2 has no statistical difference (P is more than 0.05) compared after treatment.
TABLE 4 comparison of symptom scores before and after treatment between the treated group and the control group
Note: compared with the treatment before the treatment,**p is less than 0.01; compared with the control group, the compound of the formula,##P＜0.01。
3.1.2 the results of the comparison of the total effectiveness are shown in Table 5. Compared with the total effective rate of the treatment group A and the treatment group B, the statistical difference does not exist (P is more than 0.05).
TABLE 5 comparison of clinical efficacy of the treated groups with the control group
Note: chi meridian2Test, comparison with control group, χ2Therapeutic group 24.092, P < 0.01; chi-type food processing machine2Treatment group a < 15.414, > P < 0.01; chi-type food processing machine2Treatment group b is 13.510, P < 0.01.
3.2 comparison of immunological index changes before and after treatment of group A and control group
For objective reasons, laboratory tests could not be performed on all cases in the treatment group, so 50 cases were selected from the treatment group to constitute the treatment group a, which was compared with the control group. The symptom scores before and after treatment of the group A and the group B are not statistically different (P is more than 0.05), and the total effective rate of the group 2 is not statistically different (P is more than 0.05), so that the group A and the control group can be compared to evaluate the influence of the invention on the laboratory indexes of patients.
3.2.1 the results of comparison of the changes of the five immune indexes are shown in Table 6.
3.2.2T lymphocyte subpopulation index change comparison results are shown in Table 7.
TABLE 6 comparison of five immune indexes before and after treatment in the treatment group A and the control group
Note: compared with the treatment before the treatment,*P＜0.05，**p is less than 0.01; compared with the control group after the treatment,#P＜0.05，##P＜0.01。
TABLE 7 comparison of the index changes of T lymphocyte subsets before and after treatment in the treatment group A and the control group
Note: p < 0.05, P < 0.01, compared to pre-treatment; compared with the control group after the treatment,#P＜0.05。
as can be seen from tables 6 and 7, the immunological indices of the treated groups treated with the drug of the present invention were significantly improved compared to the control group.
3.3 safety Observation indicators
No abnormal changes of liver and kidney functions and electrocardiogram are found before and after the treatment of the group A; no adverse reaction is found in the treatment process.
Finally, it should be noted that: it should be understood that the above examples are only for clearly illustrating the present invention and are not intended to limit the embodiments. Other variations and modifications will be apparent to persons skilled in the art in light of the above description. And are neither required nor exhaustive of all embodiments. And obvious variations or modifications are intended to be within the scope of the present invention.
Claims (8)
1. A traditional Chinese medicine composition for treating lung and spleen deficiency in COVID-19 recovery period is characterized by comprising 20-50 parts of codonopsis pilosula, 20-50 parts of astragalus membranaceus, 10-25 parts of bighead atractylodes rhizome, 10-25 parts of poria cocos, 10-25 parts of prepared pinellia ternate, 5-15 parts of pericarpium citri reticulatae, 10-40 parts of walnut kernels, 10-40 parts of Chinese yams, 5-15 parts of inula flowers, 5-15 parts of rhizoma cyperi, 5-15 parts of madder, 10-25 parts of cortex albiziae, 10-40 parts of rice sprouts and 5-15 parts of honey-fried licorice roots.
2. The traditional Chinese medicine composition according to claim 1, wherein the traditional Chinese medicine composition comprises 40 parts of codonopsis pilosula, 40 parts of astragalus membranaceus, 20 parts of bighead atractylodes rhizome, 20 parts of poria cocos, 20 parts of prepared pinellia ternate, 12 parts of pericarpium citri reticulatae, 30 parts of walnut kernels, 30 parts of Chinese yams, 12 parts of inula flowers, 12 parts of rhizoma cyperi, 10 parts of madder, 20 parts of cortex albiziae, 30 parts of rice sprouts and 10 parts of honey-fried licorice roots.
3. The Chinese medicinal composition according to any one of claims 1 to 2, wherein the codonopsis pilosula, the bighead atractylodes rhizome and the rhizoma cyperi are raw products or processed products respectively, and the processed products are fried codonopsis pilosula, fried bighead atractylodes rhizome and vinegar-processed rhizoma cyperi; the rhizoma Pinelliae Preparada is rhizoma Pinelliae Preparata, rhizoma Pinelliae Preparada or rhizoma Pinelliae Preparada.
4. A medicament, which is characterized in that the medicament is prepared from the traditional Chinese medicine composition as claimed in any one of claims 1 to 3 and pharmaceutically acceptable auxiliary materials.
5. The medicine according to claim 4, wherein the medicine comprises decoction, granules, capsules, tablets, pills, oral liquid, tinctures, syrups, teas, sprays, inhalants, aerosols, mixtures, injections.
6. A method for preparing the traditional Chinese medicine composition as claimed in any one of claims 1 to 3, wherein the traditional Chinese medicine composition is prepared according to one of the following preparation methods:
a. collecting radix Codonopsis, radix astragali, Atractylodis rhizoma, Poria, rhizoma Pinelliae Preparada, pericarpium Citri Tangerinae, semen Juglandis, rhizoma Dioscoreae, Inulae flos, rhizoma Cyperi, radix Rubiae, cortex Albizziae, fructus oryzae, and radix Glycyrrhizae Preparata; adding 4-12 times of water, reflux-extracting for 1-3 times, each time for 0.5-3 hours, combining the extracting solutions, and concentrating under reduced pressure to obtain a water extract; or the like, or, alternatively,
b. taking radix codonopsitis, astragalus, bighead atractylodes rhizome, poria cocos, processed pinellia ternate, dried orange peel, walnut kernel, Chinese yam, inula flower, rhizoma cyperi, madder, cortex albiziae, rice sprout and honey-fried licorice root, adding 6-12 times of water for extracting for 1-3 times, each time for 0.5-2 hours, combining extracting solutions, concentrating to obtain a water extract, adding ethanol, quickly and slowly stirring until the alcohol content is 50-75%, standing, absorbing an upper layer, and recovering ethanol under reduced pressure to obtain a water extraction and alcohol precipitation extract; or the like, or a combination thereof,
c. taking radix codonopsitis, radix astragali, rhizoma atractylodis macrocephalae, poria cocos, processed pinellia ternate, pericarpium citri reticulatae, walnut kernel, Chinese yam, inula flower, rhizoma cyperi, madder, cortex albiziae, rice sprout and radix glycyrrhizae preparata, adding 6-12 times of water, carrying out warm-soaking extraction for 1-3 times, 0.5-2 hours each time, combining extracting solutions, and concentrating to obtain an extract; or the like, or, alternatively,
d. taking radix codonopsitis, radix astragali, rhizoma atractylodis macrocephalae, poria cocos, processed pinellia ternate, pericarpium citri reticulatae, walnut kernel, Chinese yam, inula flower, rhizoma cyperi, madder, cortex albiziae, rice sprout and honey-fried licorice root, adding 6-12 times of ethanol, reflux-extracting for 1-3 times, 0.5-2 hours each time, combining extracting solutions, and concentrating to obtain an extract; or the like, or, alternatively,
e. taking radix codonopsitis, radix astragali, rhizoma atractylodis macrocephalae, poria cocos, processed pinellia ternate, pericarpium citri reticulatae, walnut kernel, Chinese yam, inula flower, rhizoma cyperi, madder, cortex albiziae, rice sprout and honey-fried licorice root, respectively adding 6-12 times of water for 1-3 times, 0.5-2 hours each time, merging extracting solutions, concentrating to obtain radix codonopsitis extract, radix astragali extract, rhizoma atractylodis macrocephalae extract, poria cocos extract, processed pinellia ternate extract, pericarpium citri reticulatae extract, walnut kernel extract, Chinese yam extract, inula flower, extract, rhizoma cyperi extract, madder extract, cortex albiziae extract, rice sprout extract and honey-fried licorice root extract, and mixing.
7. A process for the preparation of a medicament according to claim 4 or 5, wherein the medicament is selected from the group consisting of granules, which process comprises:
taking radix codonopsitis, radix astragali, rhizoma atractylodis macrocephalae, poria cocos, processed pinellia ternate, pericarpium citri reticulatae, walnut kernel, Chinese yam, inula flower, rhizoma cyperi, madder, cortex albiziae, rice sprout and honey-fried licorice root, adding 8-12 times of water for extracting for 1-3 hours, filtering, adding 6-10 times of water for reflux extraction for 1-2 hours, combining extracting solutions, concentrating under reduced pressure to obtain an extract, drying, crushing to obtain a middle body composition, adding auxiliary materials, and granulating.
8. Use of the Chinese medicinal composition of any one of claims 1-3 in the preparation of a medicament for treating lung and spleen deficiency in convalescent period of COVID-19.
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