A Chinese medicine composition for the recovery period of novel coronavirus infection and its preparation method and application

Abstract

The present invention discloses a Chinese medicine composition for the recovery period of novel coronavirus infection, and its preparation method and application, which is made of the following raw materials by weight: 3.5-5.5 parts of American ginseng, 6-9 parts of roasted astragalus, 3.5-5.5 parts of epimedium, 1-2 parts of Panax notoginseng, 6-8 parts of yam, 4-6 parts of Poria, 6-9 parts of raw rehmannia, 5-7 parts of lily, 3.5-5.5 parts of oriental rhizome, 1-2 parts of cinnamon bark, 6-9 parts of roasted malt, 2-4 parts of costusroot, 4-6 parts of rhizoma anemarrhenae and 2-4 parts of roasted licorice. The whole prescription of the present invention focuses on strengthening the spleen and lungs, tonifying the kidney and consolidating the essence, and is used to treat upper respiratory tract infection, pneumonia, etc., such as lung spleen and kidney deficiency and deficiency of vital energy in the recovery period of novel coronavirus infection, with significant therapeutic effect.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and in particular relates to a traditional Chinese medicine composition for the recovery period of novel coronavirus infection, and a preparation method and application thereof. Background Art

[0002] Novel coronavirus infection is an acute infectious disease caused by the new coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

[0003] The clinical symptoms of novel coronavirus infection are mainly fever, dry cough, fatigue, and nasal congestion, runny nose, sore throat, decreased or loss of smell and taste. Common clinical manifestations of cases in the recovery period of novel coronavirus infection mainly include general fatigue, muscle aches, headaches, joint pains; transient neurological symptoms such as impaired consciousness and thinking; autonomic nerve disorders such as decreased smell and taste, sleep disorders, and repeated sweating; and even cardiopulmonary dysfunction such as long-term cough, shortness of breath, and palpitations. In addition, some patients also have gastrointestinal symptoms such as diarrhea and vomiting. It can be seen that the novel coronavirus infection has not completely stopped, and long-term intervention in the recovery period is still worthy of attention.

[0004] At present, antiviral drugs such as namatevir / ritonavir tablets, azithromycin, lopinavir / ritonavir, ribavirin, and oseltamivir are believed to have a certain therapeutic effect on early COVID-19, but there is no clear intervention therapy for long-term COVID-19 symptoms. COVID-19 infection belongs to the category of "epidemic disease", "cold", "typhoid fever", "severe cold", and "consumption" in traditional Chinese medicine. It is caused by the poison of wind and cold. The cold poison invades the human body, and the struggle between the positive and the negative is overcome. After the positive energy is greatly damaged, it leads to insufficient vitality of the five internal organs, deficiency of qi, blood, yin and yang in the recovery period, and a small amount of negative energy lurks inside. If it is not properly adjusted, it is very easy to relapse. Under the guidance of my country's health and health work policy of "giving equal importance to traditional Chinese and Western medicine", traditional Chinese medicine has played a role in reducing toxicity and increasing efficacy in the treatment of COVID-19 infection and its recovery period. Summary of the invention

[0005] The technical problem to be solved by the present invention is to overcome the deficiencies and defects mentioned in the above background technology, and to provide a traditional Chinese medicine composition for the recovery period of new coronavirus infection for long-term new coronavirus symptoms, as well as a preparation method and application thereof.

[0006] In order to solve the above technical problems, the technical solution proposed by the present invention is:

[0007] A traditional Chinese medicine composition for the recovery period of novel coronavirus infection, which is made of the following raw materials in parts by weight: 3.5-5.5 parts of American ginseng, 6-9 parts of roasted astragalus, 3.5-5.5 parts of epimedium, 1-2 parts of Panax notoginseng, 6-8 parts of yam, 4-6 parts of Poria, 6-9 parts of Rehmannia root, 5-7 parts of lily, 3.5-5.5 parts of Alisma, 1-2 parts of cinnamon, 6-9 parts of roasted malt, 2-4 parts of costus root, 4-6 parts of Anemarrhena and 2-4 parts of roasted liquorice.

[0008] Preferably, it is made of the following raw materials in parts by weight: 4.5 parts of American ginseng, 7.5 parts of roasted astragalus, 4.5 parts of epimedium, 1.5 parts of Panax notoginseng, 7.5 parts of yam, 5 parts of Poria, 7.5 parts of Rehmannia root, 6 parts of lily, 4.5 parts of Alisma, 1.5 parts of cinnamon, 7.5 parts of roasted malt, 3 parts of costus root, 4.5 parts of Anemarrhena and 3 parts of roasted licorice.

[0009] The present invention also provides a traditional Chinese medicine preparation for use in the recovery period of novel coronavirus infection, comprising the traditional Chinese medicine composition and excipients.

[0010] Preferably, it is in the form of granules.

[0011] The present invention also provides a method for preparing the Chinese medicine preparation, comprising the following steps:

[0012] (1) boiling each raw material in the Chinese medicine composition according to claim 1 or 2 with water, and filtering to obtain a filtrate;

[0013] (2) concentrating the filtrate to obtain a thick paste;

[0014] (3) Dry the thick paste, add auxiliary materials, and then make granules.

[0015] Preferably, step (1) adopts a process of decocting twice.

[0016] Preferably, step (2) is first concentrated for the first time, then centrifuged, and then concentrated for the second time to obtain a thick paste.

[0017] Preferably, the first concentration to a concentrated solution with a relative density of 1.05 to 1.08 is tested at a relative density of 60°C;

[0018] The centrifugal speed is ≥7000rpm.

[0019] Preferably, the auxiliary material in step (3) is dextrin, and the mass ratio of dry paste to dextrin is 50:(45-55);

[0020] In the process of making granules, 87-88% ethanol is used as a wetting agent.

[0021] The present invention also provides a use of the traditional Chinese medicine composition in the preparation of a medicine for the recovery period of novel coronavirus infection.

[0022] The Chinese medicine composition provided by the invention comprises the following medicinal flavors: American ginseng, roasted astragalus, epimedium, notoginseng, yam, tuckahoe, raw rehmannia, lily, oriental water plantain, cinnamon bark, fried malt, costusroot, anemarrhena, and roasted liquorice.

[0023] American ginseng is the dried root of Panax quinguefolium L., a plant of the Araliaceae family. It is dug up in autumn, washed, sun-dried or dried at low temperature. Cut into thin slices or crushed when used. It has a light fragrance and a strong taste, and tastes slightly bitter and sweet. The ones with tight horizontal lines on the surface, light fragrance and strong taste are preferred. Used raw. Sweet, slightly bitter, and cool. It enters the heart, lung, and kidney meridians. It replenishes qi and nourishes yin, clears heat and produces body fluid. It is used for shortness of breath and shortness of breath caused by qi deficiency and yin deficiency, deficiency heat and fatigue, cough, asthma, sputum and blood damage to the qi and yin of the lungs, cough with little sputum, or blood in sputum, qi deficiency and body fluid damage, dry mouth and throat, internal heat and thirst. It has the effects of resisting hypoxia, fatigue, improving and enhancing memory.

[0024] Roasted Astragalus is the dried root of Astragalus membranaceus (Fisch.) Bge. var. mongholicus (Bge.) Hsiao or Astragalus membranaceus (Fisch.) Bge. of the Leguminosae family. It is collected in spring and autumn, the fibrous roots and root heads are removed, dried in the sun, and sliced. This product has a faint smell and a slightly sweet taste. It is sweet and slightly warm. It enters the spleen and lung meridians. It replenishes qi and raises yang, strengthens the body's defense system, promotes diuresis and reduces swelling, promotes the production of body fluids and nourishes blood, relieves arthritis, removes toxins and discharges pus, and promotes the growth of muscles in sores. It is used for qi deficiency and fatigue, poor appetite and loose stools, weak lung qi, cough and shortness of breath, spontaneous sweating due to deficiency of the exterior, internal heat and thirst, blood deficiency and sallow complexion, qi and blood deficiency, qi and blood stagnation, and qi and blood deficiency. Astragalus polysaccharide can promote RNA and protein synthesis, make cells grow vigorously, prolong life, and resist fatigue, low temperature, and influenza virus. Astragalus also has anti-aging, anti-radiation, anti-inflammatory, lipid-lowering, blood sugar-lowering, immunity-enhancing, anti-tumor and liver-protecting effects.

[0025] Epimedium is the dried leaves of Epimedium brevicornu Maxim., Epimedium sagittatum (Sieb.et Zucc.) Maxim., Epimedium Pubescens Maxim. or Epimedium koreanum Nakai. of the Berberidaceae family. It is mainly produced in Shanxi, Sichuan, Hubei and Jilin. It is harvested in summer and autumn when the stems and leaves are lush, and dried in the sun or in the shade. This product has a slight smell and a slightly bitter taste. The leaves with many leaves and yellow-green color are preferred. It is pungent, sweet and warm. It enters the liver and kidney meridians. It nourishes the kidney and strengthens yang, strengthens the tendons and bones, and eliminates rheumatism. It is used for kidney yang deficiency, impotence and spermatorrhea, tendon weakness, wind-cold dampness arthralgia, numbness and cramps. Epimedium can also improve the functions of the cardiovascular system, bone marrow and hematopoietic system, resist osteoporosis, improve learning and memory, resist radiation, and have anti-tumor effects.

[0026] Panax notoginseng is the dried root and rhizome of Panax notoginseng (Burk.) FHChen of the Araliaceae family. It is collected in autumn before the flowers bloom, washed, the main root, lateral roots and rhizome are separated, and dried. This product has a faint smell and a light taste. The ones that are large, heavy, solid, and gray-green in cross section are preferred. Slice, mash, or grind into fine powder for use. It is sweet, slightly bitter, and warm. It enters the liver and stomach meridians. It can disperse blood stasis and stop bleeding, reduce swelling and relieve pain. It is used for coughing up blood, vomiting blood, epistaxis, blood in stool, hematuria, metrorrhagia, bleeding due to trauma, chest and abdominal pain due to blood stasis, swelling and pain due to falls, and consumptive injuries.

[0027] Chinese yam is the dried rhizome of Dioscorea opposita Thunb. of the Dioscoreaceae family. It is dug up in winter when the stems and leaves wither, the root head is cut off, washed, the outer skin and fibrous roots are removed, and dried, or cut into thick slices while fresh and dried; some people also choose large and straight dried Chinese yam, put it in clean water, soak it until there is no dry core, cut the two ends evenly, rub it into a cylindrical shape with a wooden board, dry it, and polish it. This product tastes light and slightly sour, and it becomes sticky when chewed. It is sweet in nature and has a flat taste. It enters the spleen, lung, and kidney meridians. It replenishes qi and nourishes yin, nourishes the spleen, lungs, and kidneys, and stops leukorrhea. It is used for spleen deficiency, poor appetite, loose stools, lung deficiency, asthma and cough, deficiency heat and thirst, kidney deficiency, soreness of waist and knees, and frequent urination at night.

[0028] Poria cocos is the dried sclerotium of the Polyporaceae fungus Poria cocos (Schw.) Wolf. It is usually harvested from July to September. After being dug out, the mud and sand are removed, and the leaves are piled up to "sweate". Then they are spread out to dry on the surface, and then "sweated" again. This process is repeated several times until wrinkles appear and most of the internal water is lost. Then they are dried in the shade. Alternatively, fresh Poria cocos is cut into different parts and dried in the shade. These are called "Poria cocos blocks" and "Poria cocos slices" respectively. This product has a slight smell and a light taste. It is sweet, light, and flat. It enters the heart, lung, spleen, and kidney meridians. It can promote diuresis and eliminate dampness, strengthen the spleen, and calm the mind. It is used for edema, oliguria, phlegm and fluid, dizziness and palpitations, spleen deficiency and poor appetite, loose stools and diarrhea, restlessness, palpitations and insomnia. Poria cocos polysaccharides have the effect of enhancing immune function.

[0029] Shengdihuang is the dried root of Rehmannia glutinosa Libosch., a plant of the Scrophulariaceae family. It is dug in autumn, the root head, fibrous roots and mud are removed, and it is baked until it is about 80% dry. This product has a slight odor and a slightly sweet taste. The ones with black cut surface are preferred. It is sweet and cold. It enters the heart, liver and kidney meridians. It clears heat and cools blood, nourishes yin and produces body fluid. It is used for heat entering the blood, fever caused by warm toxins, bleeding caused by blood heat, damage to yin due to febrile diseases, red tongue and thirst, internal heat and thirst, fever caused by yin deficiency, fever caused by bone steaming and fatigue, and constipation caused by damage to body fluid.

[0030] Lily is the dried fleshy scales of Lilium lancifolium Thunb., Lilium brownii F.E.Brown var.viridulum Baker or Lilium pumilum DC. of the Liliaceae family. It is collected in autumn, washed, peeled, and scalded in boiling water, and dried. This product has a slight smell and a slightly bitter taste. The best ones are those with uniform and thick scales, less tendons, hard texture, white color, and slightly bitter taste. It is sweet and cold. It enters the heart and lung meridians. It nourishes yin and moistens the lungs, clears the heart and calms the mind. It is used for lung yin deficiency syndromes such as yin deficiency and dry cough, cough due to fatigue and hemoptysis, and heart yin deficiency syndromes such as restlessness, palpitations, insomnia, dreaminess, and mental confusion. Lily water extract has sedative, anti-hypoxia and anti-fatigue effects.

[0031] Alisma orientalis (Sam.) Juzep. or Alisma plantago-aquatica Linn. is a dried tuber of the Alismataceae family. It is collected in winter when the stems and leaves begin to wither, washed, dried, the fibrous roots and rough bark are removed, cut into thick slices, and dried in the sun. This product has a slight odor and a slightly bitter taste. The ones with yellowish-white cut surface and sufficient powderiness are preferred. It can be used raw or roasted in salt water. It is sweet, light, and cold. It enters the kidney and bladder meridians. It can promote diuresis and eliminate dampness, relieve heat, and reduce turbidity and lipids. It is used for edema, dysuria, diarrhea, oliguria, phlegm and dizziness, painful stranguria caused by heat, spermatorrhea, and hyperlipidemia.

[0032] Cinnamon bark is the dried bark of Cinnamomum cassia Presl, a plant of the Lauraceae family. It is processed into various specifications due to different peeling parts and qualities, and the most common ones are cinnamon with side, board, and oil board. It is pungent, sweet, and very hot. It enters the kidney, spleen, heart, and liver meridians. It replenishes fire and helps yang, dispels cold and relieves pain, warms and dredges the meridians, and guides fire back to the origin. It is used for kidney yang deficiency, life gate fire decline, impotence and cold uterus, cold pain in the waist and knees, cold pain in the heart and abdomen, vomiting and diarrhea due to deficiency cold, abdominal pain due to cold hernia, dysmenorrhea and amenorrhea due to deficiency cold in Chong and Ren meridians, cold blood stasis, cold and dampness arthralgia, yin carbuncle, asthma due to kidney deficiency, floating of deficiency yang, dizziness and red eyes.

[0033] Roasted malt is a processed product of the mature fruit of Hordeum vulgare L., a grass plant, which is germinated and dried. Soak the grains in water, maintain appropriate temperature and humidity, and when the young sprouts grow to about 5mm, dry them in the sun or at low temperature. This product has a slight odor and a slightly sweet taste. The best ones are those with complete sprouts, light yellow color, large and plump grains. Use it raw, stir-fry until it turns yellow or charred. It is sweet and neutral. It enters the spleen and stomach meridians. It promotes qi and digestion, strengthens the spleen and stimulates appetite, and relieves bloating. It is used for indigestion, abdominal distension, spleen deficiency, poor appetite, and liver depression and pain in the ribs.

[0034] Aucklandia lappa is the dried root of Aucklandia lappa Decne. It is collected in autumn and winter, and the sand and fibrous roots are removed and cut into sections. The large ones are cut into petals longitudinally, and the rough skin is removed after drying. This product has a unique aroma and a slightly bitter taste. The ones with strong aroma and sufficient oiliness are preferred. Cut into thick slices and use raw or stewed. It is pungent, bitter and warm. It enters the spleen, stomach, large intestine, triple burner and gallbladder meridians. It promotes qi and relieves pain, strengthens the spleen and promotes digestion. It is used for spleen and stomach qi stagnation, abdominal distension and pain, indigestion, loss of appetite, heaviness after diarrhea, chest and flank distension and pain, jaundice, and hernia pain. This product also has anti-tumor, vasodilator and platelet aggregation inhibition effects.

[0035] Zhimu is the dried rhizome of Anemarrhena asphodeloides Bge., a plant of the Liliaceae family. It is collected in spring and autumn, the fibrous roots and mud are removed, and the skin is dried in the sun; or the skin is removed and dried in the sun. Cut into slices. This product has a slight smell, a slightly sweet and slightly bitter taste, and is sticky when chewed. The cut surface is yellowish and white, which is preferred. It is used raw or roasted in salt water. It is bitter in nature, sweet in taste, and cold. It enters the lung, stomach, and kidney meridians. It clears away heat and purges fire, nourishes yin and moistens dryness. It is used for exogenous febrile diseases, high fever and thirst, cough due to lung heat, dry cough due to yin deficiency, bone steaming and tidal fever, internal heat and thirst, and constipation due to yin deficiency and dry intestines. Zhimu extract has antipyretic effects, and can also inhibit platelet aggregation, lower blood sugar, anti-inflammatory, diuretic, anti-bacterial, anti-cancer, anti-ulcer, improve learning and memory ability, and protect cerebral ischemic damage.

[0036] Roasted Licorice is the dried root and rhizome of Glycyrrhiza uralensis Fisch., Glycyrrhiza infata Bat. or Glycyrrhiza glabra L. of the Leguminosae family. It is dug in spring and autumn, the fibrous roots are removed, dried in the sun and cut into thick slices. This product has a slight smell and a special sweet taste. The ones with fine and tight skin, reddish brown outer color, sufficient powder and sweet taste are preferred. It is sweet and flat. It enters the heart, lung, spleen and stomach meridians. It nourishes the spleen and replenishes qi, clears away heat and detoxifies, eliminates phlegm and relieves cough, relieves pain and harmonizes various medicines. It is used for spleen and stomach weakness, fatigue, insufficient heart qi, palpitations and shortness of breath, irregular pulse, carbuncle, sore throat, cough and sputum, and acute pain in the abdomen and limbs. Glycyrrhizic acid, glycyrrhetinic acid and flavonoids of licorice have antitussive, expectorant and antiasthmatic effects.

[0037] Compared with the prior art, the present invention has the following beneficial effects:

[0038] During the research process of the present invention, it is considered that the lung, spleen and kidney are deficient in the recovery period of the new crown, and the internal organs are damaged for a long time, the qi is deficient and the blood cannot circulate, and the blood stagnates and becomes stasis. Deficiency of the lung, spleen and kidney can be seen as shortness of breath, asthma, sleep disorders, cold limbs, frequent urination, etc., pale tongue with white fur, and deep and fine pulse. The pharmaceutical composition provided by the present invention is modified from Jinkui Shenqi Pills, and roasted astragalus, epimedium, lily, American ginseng, rhizoma anemarrhenae, stir-fried malt, costus root, and Panax notoginseng are added. The whole recipe plays the effect of strengthening the spleen and lungs, tonifying the kidney and consolidating the essence.

[0039] In the formula, roasted Astragalus root can replenish Qi and raise Yang, benefit the body's defense system and consolidate the exterior, and is the main drug. Raw Rehmannia root can clear away heat and promote the production of body fluid, cool blood and stop bleeding, and nourish Yin and blood; Chinese yam and Poria can replenish Qi and nourish Yin, and nourish the spleen, lungs and kidneys; Cinnamon bark can replenish fire and boost Yang, dispel cold and relieve pain, warm and dredge the meridians, and guide fire back to the origin, and these four drugs are the assistant drugs. Epimedium is added to replenish kidney Yang, American ginseng, Anemarrhena asphodeloides, and Lilium can nourish Yin and relieve restlessness to prevent excessive yang replenishment; Alisma orientalis can promote diuresis and relieve heat; roasted malt and costus root can promote Qi and digestion, strengthen the spleen and stimulate appetite. Moreover, if Qi is deficient for a long time, blood circulation will be weak, and blood stasis will turn into blood stasis, so Panax notoginseng is added to disperse blood stasis and relieve pain, as an adjuvant drug.

[0040] The prescription of the present invention is concise and rigorous, taking into account the lung, spleen and kidney, and has the effects of strengthening the spleen and lung, tonifying the kidney and consolidating the essence. It is taken orally and is used to treat upper respiratory tract infections, pneumonia, etc., such as lung, spleen and kidney deficiency and deficiency of vital energy in the recovery period of new coronavirus infection, with significant efficacy. The prescription dosage and dosage form of the present invention are stable. DETAILED DESCRIPTION

[0041] In order to facilitate the understanding of the present invention, the present invention will be described more comprehensively and carefully in combination with preferred embodiments below, but the protection scope of the present invention is not limited to the following specific embodiments.

[0042] Unless otherwise defined, all professional terms used below have the same meanings as those generally understood by those skilled in the art. The professional terms used herein are only for the purpose of describing specific embodiments and are not intended to limit the scope of protection of the present invention.

[0043] Unless otherwise specified, various raw materials, reagents, instruments and equipment used in the present invention can be purchased from the market or prepared by existing methods.

[0044] The traditional Chinese medicine composition for the recovery period of novel coronavirus infection of the present invention is prepared from the following raw materials in parts by weight: 3.5-5.5 parts of American ginseng, 6-9 parts of roasted astragalus, 3.5-5.5 parts of epimedium, 1-2 parts of Panax notoginseng, 6-8 parts of yam, 4-6 parts of Poria, 6-9 parts of Rehmannia, 5-7 parts of lily, 3.5-5.5 parts of Alisma, 1-2 parts of cinnamon, 6-9 parts of roasted malt, 2-4 parts of costus root, 4-6 parts of Anemarrhena, and 2-4 parts of roasted licorice.

[0045] Preferably, it is made from the following raw materials in parts by weight: 4.5 parts of American ginseng, 7.5 parts of roasted astragalus, 4.5 parts of epimedium, 1.5 parts of Panax notoginseng, 7.5 parts of yam, 5 parts of Poria, 7.5 parts of Rehmannia root, 6 parts of lily, 4.5 parts of Alisma, 1.5 parts of cinnamon, 7.5 parts of roasted malt, 3 parts of costus root, 4.5 parts of Anemarrhena, and 3 parts of roasted licorice.

[0046] The whole prescription of the present invention focuses on strengthening the spleen and lungs, tonifying the kidneys and consolidating the vital energy. It is used to treat upper respiratory tract infections, pneumonia, etc., such as lung, spleen and kidney deficiency and deficiency of vital energy in the recovery period of new coronavirus infection, such as symptoms: fatigue, cough, shortness of breath, poor appetite, soreness of waist and knees, frequent urination at night, cold body and limbs, dizziness and tinnitus; pale tongue with thin white fur, and deep pulse. The therapeutic effect is based on the changes in symptoms such as fatigue and insomnia and objective indicators such as FAS fatigue rating scale, VAS pain visual analog score and traditional Chinese medicine symptom score.

[0047] The composition of the present invention can be used as a decoction in clinical practice, or all the medicinal materials can be boiled in water to make granules. The granules not only maintain the characteristics of rapid action of traditional decoctions, but also have the characteristics of small volume, convenient administration, storage and transportation, stable properties, and controllable quality, but also maintain the characteristics of rapid absorption and rapid action of decoctions, are convenient for patients to take, have stable quality, and are suitable for mechanized production.

[0048] The preparation method of the granules of the present invention comprises the following steps:

[0049] (1) Add water to each raw material in the composition and boil it, and filter to obtain a filtrate.

[0050] Based on the following Example 1, three decoction experiments were conducted, with the dry paste yield as the examination index. The dry paste yield of the third decoction accounted for 8.83% of the total dry paste yield, indicating that the extraction was basically complete after two decoctions, so the process of two decoctions was adopted.

[0051] Based on two decoctions, the dry paste yield is used as the main evaluation indicator. It is preferred to add 10 times the amount of water for the first time and decoct for 2 hours; add 8 times the amount of water for the second time and decoct for 1.5 hours.

[0052] (2) The filtrate is concentrated to obtain a thick paste.

[0053] In some preferred embodiments, the first concentration is performed, followed by centrifugation, and then a second concentration is performed to obtain a thick paste.

[0054] The first concentration is preferably carried out at a concentration temperature of 60-70°C, a vacuum degree of -0.06-0.08Mpa, and a concentrate having a relative density of about 1.05-1.08 (60°C). If the temperature is too low, the concentration time will be long; if the temperature is too high (e.g. 80°C), foaming will easily occur during the concentration process, and it will take half an hour to stabilize, which will easily cause material loss.

[0055] Research has found that the relative density of the solution before centrifugation affects the solubility of the product. If the relative density of the solution before centrifugation is too high, it will lead to incomplete centrifugation, thus affecting the solubility of the product and easily causing material loss. Therefore, the relative density of the liquid medicine before centrifugation of the present invention is controlled at 1.05-1.08 (60°C). For example, based on the following Example 1, if the relative density is controlled to be 1.10, at the same centrifugal speed and centrifugal time, a small amount of precipitation will be present at the bottom of the centrifuge when it is left standing overnight.

[0056] The centrifugal speed also affects the solubility of the product. The solubility of the supernatant of the concentrated liquid at a speed of ≥7000rpm meets the requirements. Based on the following Example 1, if the centrifugal speed is too low, for example 5000rpm, the centrifuge will have precipitation at the bottom when it is left to stand overnight.

[0057] The second concentration preferably has a concentration temperature of 60 to 70° C. and a vacuum degree of -0.06 to -0.08 MPa, and is concentrated to a thick paste with a relative density of 1.20 to 1.25 (60° C.).

[0058] (3) Dry the thick paste, add auxiliary materials, and then make granules.

[0059] The preferred drying temperature is 60-70°C and the vacuum degree is -0.06--0.08Mpa. Based on the following Example 1, if the temperature is too high, for example 80°C, there is expansion and the high temperature is easy to destroy the effective ingredients in the dry paste.

[0060] The present invention adopts a full water extraction process, and the obtained extract powder has relatively good solubility, but has large hygroscopicity, poor fluidity and compressibility, and needs to add appropriate auxiliary materials to improve the properties of the extract powder.

[0061] In some preferred embodiments, dextrin is used as an auxiliary material. Dextrin does not block the screen during granulation, is easy to granulate after drying, has uniform granules, good solubility, and is cheap and has good moisture resistance. Based on the following Example 1, if soluble starch is used for granulation, the screen is slightly blocked, it is a bit lumpy, it is slightly lumpy when drying, the granules are harder, and it is more difficult to granulate. If maltodextrin is used to make soft materials, it is a bit sticky, part of it is lumpy, the screen is slightly blocked during granulation, it is a bit lumpy, the granules are loose and fragile during granulation, and there are more fine powders.

[0062] The preferred mass ratio of dry paste powder to dextrin is 50:(45-55). The preferred raw material and auxiliary material ratio is: dry paste powder to dextrin is 1:1. Based on the following Example 1, if the amount of dextrin is small, for example 50:40, the screen will be blocked and the particle yield will be low.

[0063] In some preferred embodiments, ethanol is used as a wetting agent. The dry paste of this preparation has strong viscosity and is easy to clump when it meets water, causing the soft material to be too sticky and difficult to granulate. 87% (volume) ethanol is preferred, the particle yield is the highest, the particle size meets the requirements, and it is easy to granulate, and the particle color is uniform. Based on the following embodiment 1, if the volume fraction is low, such as 85%, the granulation will block the screen, most of them are lumpy, and a few cannot be made. If the volume fraction is high, such as 92%, there are more small granules in granulation, and the particles are loose and have fine powder during granulation. When the dosage of 87% ethanol is 25-30% (based on the total mass of dry paste + dextrin), from the aspects of granulation, drying, granulation process, particle yield and particle size, each investigation index is better.

[0064] In some preferred embodiments, the flavoring agent is steviol glycoside, preferably in an amount of 0.2%, based on the total mass of dry paste + dextrin.

[0065] During production, it was found that if the granule drying temperature is less than 60°C, it is difficult to control in large-scale production; if the granule drying temperature is greater than 70°C, it may destroy the effective ingredients of the product and easily cause agglomeration during the drying process, so 60-70°C is selected as the granule drying temperature.

[0066] Example 1

[0067] The composition of this embodiment includes: 4.5g American ginseng, 7.5g roasted astragalus, 4.5g epimedium, 1.5g Panax notoginseng, 7.5g yam, 5g Poria, 7.5g Rehmannia root, 6g lily, 4.5g Alisma, 1.5g cinnamon, 7.5g roasted malt, 3g costus root, 4.5g Anemarrhena, and 3g roasted licorice.

[0068] Preparation method of granules:

[0069] (1) Extraction of medicinal materials: Weigh the Chinese medicinal pieces according to the prescription ratio, add water and boil twice. For the first time, add 10 times the amount of water, boil for 2 hours, and filter; for the second time, add 8 times the amount of water, boil for 1.5 hours, filter, and combine the filtrates.

[0070] (2) Concentration of drug solution: Place the drug solution in a concentration tank and concentrate under reduced pressure (temperature 60-70°C, vacuum degree -0.06-0.08 MPa to a relative density of 1.05-1.08 (measured at 60°C)).

[0071] (3) Centrifugation: The concentrate is centrifuged at a speed of 7000 rap / min for 5 min.

[0072] (4) Concentration of the centrifuge liquid: The centrifuge liquid is further concentrated under reduced pressure to a thick paste having a relative density of 1.20 to 1.25 (measured at 60°C).

[0073] (5) Vacuum drying: Vacuum drying (temperature 60-70°C, vacuum degree -0.06-0.08Mpa) to obtain about 12g of dry paste.

[0074] (6) Grinding: Grind the dry paste and dextrin powder (1:1) into fine powder and mix well.

[0075] (7) Granulation, drying and granulation: Take an appropriate amount of stevioside (0.2%) and dissolve it in 87% ethanol (25-30%) to prepare a soft material, granulate it with a 12-mesh sieve, dry it at 60-70°C, and granulate it with a 12-mesh sieve to obtain dry granules.

[0076] (8) Granule packaging (2 packs).

[0077] The dry paste yield of this embodiment is 22.43%. The solubility of the finished product meets the requirements, and American ginseng, notoginseng TLC, rhizoma anemarrhenae TLC, aucklandiae TLC, and licorice root TLC can all be detected.

[0078] Example 2

[0079] The composition of this embodiment includes: 4g American ginseng, 7g roasted astragalus, 4g epimedium, 1.2g Panax notoginseng, 7g yam, 4.5g Poria, 7g Rehmannia root, 5.5g lily, 4g Alisma, 1.2g cinnamon, 7g roasted malt, 2.5g costusroot, 4g Anemarrhena, and 2.5g roasted licorice.

[0080] The preparation method of the granules is the same as that of Example 1.

[0081] Example 3

[0082] The composition of this embodiment includes: 5g of American ginseng, 8g of roasted astragalus, 5g of epimedium, 1.8g of Panax notoginseng, 8g of yam, 5.5g of Poria, 8g of Rehmannia root, 6.5g of lily, 5g of Alisma, 1.8g of cinnamon, 8g of roasted malt, 3.5g of costus root, 5g of Anemarrhena, and 3.5g of roasted licorice.

[0083] The preparation method of the granules is the same as that of Example 1.

[0084] Clinical Cases

[0085] Clinical Case 1

[0086] A, female, 67 years old;

[0087] The patient came to the clinic due to recovery from COVID-19 infection (body aches and pains), and was given the granules prepared in Example 1 for a course of 14 days.

[0088] Diagnosis: Recovery from COVID-19 infection

[0089] Current symptoms: body aches, affecting work and life; frequent urination at night, twice a night; severe dizziness, often aggravated by activities; frequent tinnitus, lasting for several minutes, slightly affecting hearing.

[0090] Concomitant diseases: None.

[0091] The relevant examinations showed: COVID-19 antibody IgG 112.10S / CO. Blood pressure: 119 / 81mmHg, heart rate: 80 times / min, respiration: 21 times / min, body temperature: 36.3℃.

[0092] Related scale assessment: FAS fatigue rating scale: 14 points, Pittsburgh Sleep Quality Index (PSQI): 5 points, VAS pain visual analogue scale: 5 points, Traditional Chinese Medicine symptom score: 12 points, MMSE scale: 29 points, Hamilton Depression Rating Scale (HAMD-17): 0 points.

[0093] When the patient came to the clinic, he had body aches, frequent urination at night, dizziness, tinnitus, pale red tongue, thick and greasy fur, and thin pulse. The four examinations combined with TCM syndrome differentiation were lung spleen and kidney deficiency syndrome, and the patient was given spleen and lung invigorating, kidney and consolidating Chinese medicine, and treated with the granules prepared in Example 1. 1 pack / time, 2 times / day, for 14 days.

[0094] After 14 days of treatment, the following indicators were reviewed: blood pressure: 132 / 76 mmHg, heart rate: 98 beats / min, respiration: 19 times / min, body temperature: 36.3°C. The patient's general fatigue, soreness, insomnia and other symptoms were significantly improved.

[0095] Related scales: FAS fatigue rating scale: 10 points, Pittsburgh sleep quality index (PSQI): 4 points, VAS pain visual analog scale: 0 points, TCM symptom score: 1 point, MMSE scale: 30 points, Hamilton depression rating scale (HAMD-17): 0 points. After treatment, no obvious abnormalities were found in the three routine tests, liver and kidney function, and electrocardiogram.

[0096] After treatment with the granules prepared in Example 1, the patients' FAS fatigue rating scale, VAS pain visual analogue score and TCM symptom score were significantly reduced.

[0097] Clinical Case 2

[0098] B, male, 43 years old;

[0099] The patient came to the hospital for treatment in the recovery period of novel coronavirus infection (insomnia, easy sweating, shortness of breath during activities, and nausea when getting up in the morning). The granules prepared in Example 1 were given for treatment, and the course of treatment was 14 days.

[0100] Diagnosis: Recovery from COVID-19 infection

[0101] Current symptoms: Occasionally feel tired and weak, cough when the throat is irritated, and have white sputum; have difficulty falling asleep at night, often feel cold limbs when sleeping, feel hot all over and sweat when the weather turns hot, and go to the toilet more frequently; complain of occasional drowsiness and lack of energy; feel short of breath after climbing stairs or doing heavy physical labor; feel nauseous and want to vomit when getting up in the morning.

[0102] Concomitant diseases: None.

[0103] The relevant examinations showed: COVID-19 antibody IgG 4.6S / CO. Blood pressure: 180 / 120mmHg, heart rate: 78 times / min, respiration: 20 times / min, body temperature: 36.6℃.

[0104] Related scale assessment: FAS fatigue rating scale: 18 points, Pittsburgh Sleep Quality Index (PSQI): 6 points, VAS pain visual analogue scale: 0 points, Traditional Chinese Medicine symptom score: 14 points, MMSE scale: 30 points, Hamilton Depression Rating Scale (HAMD-17): 1 point.

[0105] When the patient came to the clinic, he often felt weak, had frequent urination at night, intermittent cough, spontaneous sweating, aversion to wind, occasional dry mouth and throat, cold body and cold limbs, dizziness, tinnitus, pale red tongue, white fur, and deep and thin pulse. The four examinations combined with TCM syndrome differentiation were lung spleen and kidney deficiency syndrome, and the Chinese medicine for strengthening spleen and lung, tonifying kidney and consolidating essence was given, and the granules prepared in Example 1 were used for treatment. 1 pack / time, 2 times / day, for 14 days.

[0106] After 14 days of treatment, the following indicators were reviewed: blood pressure: 117 / 73 mmHg, heart rate: 85 beats / min, respiration: 20 times / min, body temperature: 36.5°C. The patient's general fatigue and insomnia symptoms were significantly improved.

[0107] Related scales: FAS fatigue rating scale: 15 points, Pittsburgh sleep quality index (PSQI): 9 points, VAS pain visual analog scale: 1 point, TCM symptom score: 4 points, MMSE scale: 30 points, Hamilton depression rating scale (HAMD-17): 1 point. After treatment, no obvious abnormalities were found in the three routine tests, liver and kidney function, and electrocardiogram.

[0108] After treatment with the granules prepared in Example 1, the patient's FAS fatigue rating scale and TCM symptom scores were significantly reduced.

[0109] Clinical Case 3

[0110] C, male, 24 years old;

[0111] The patient came to the hospital for treatment due to recovery from COVID-19 infection (fatigue, cervical pain and discomfort), and was given the granules prepared in Example 1 for treatment for 14 days.

[0112] Diagnosis: Recovery from COVID-19 infection

[0113] Current symptoms: fatigue, cervical pain, cough and sputum, and poor sleep quality.

[0114] Concomitant diseases: None.

[0115] The relevant examinations showed: COVID-19 antibody IgG 113.57S / CO. Blood pressure: 112 / 73mmHg, heart rate: 78 times / min, respiration: 21 times / min, body temperature: 36.5℃.

[0116] Related scale assessment: FAS fatigue rating scale: 18 points, Pittsburgh Sleep Quality Index (PSQI): 7 points, VAS pain visual analogue scale: 0 points, Traditional Chinese Medicine symptom score: 10 points, MMSE scale: 30 points, Hamilton Depression Rating Scale (HAMD-17): 8 points.

[0117] When the patient came to the clinic, he felt tired and weak, with cervical pain and discomfort, which did not affect his work and life. He occasionally coughed and expectorated, was prone to insomnia at night, had occasional tinnitus, had a pale red tongue, a thin white fur, and a deep and fine pulse. The four examinations combined with the TCM syndrome differentiation were lung, spleen and kidney deficiency syndromes, and the Chinese medicine for strengthening the spleen and lungs and tonifying the kidney and consolidating the essence was given, and the granules prepared in Example 1 were used for treatment. 1 pack / time, 2 times / day, for 14 days of treatment.

[0118] After 14 days of treatment, the following indicators were reviewed: blood pressure: 117 / 73 mmHg, heart rate: 85 beats / min, respiration: 20 times / min, body temperature: 36.5°C. The patient's symptoms of general fatigue, cough and sputum were significantly improved.

[0119] Related scales: FAS fatigue rating scale: 19 points, Pittsburgh sleep quality index (PSQI): 6 points, VAS pain visual analog scale: 1 point, TCM symptom score: 6 points, MMSE scale: 30 points, Hamilton depression rating scale (HAMD-17): 0 points. After treatment, no obvious abnormalities were found in the three routine tests, liver and kidney function, and electrocardiogram.

[0120] After treatment with the granules prepared in Example 1, the patient's TCM symptom score and Hamilton Depression Rating Scale (HAMD-17) score were significantly reduced.

[0121] Clinical Case 4

[0122] D, female, 47 years old;

[0123] The patient came to the clinic due to recovery from COVID-19 infection (body aches and pains), and was given the granules prepared in Example 1 for a course of 14 days.

[0124] Diagnosis: Recovery from COVID-19 infection

[0125] Current symptoms: The patient feels general fatigue, occasionally coughs and produces sputum, wakes up easily at night, has difficulty falling asleep after waking up, gets up frequently at night, complains of heavy snoring after falling asleep, is usually afraid of heat, has cold limbs when the weather turns cool, occasionally has nightmares, 1-2 times / week; occasionally feels tired.

[0126] Concomitant diseases: None.

[0127] The relevant examinations showed: COVID-19 antibody IgG 172.04S / CO. Blood pressure: 130 / 80mmHg, heart rate: 80 times / min, respiration: 20 times / min, body temperature: 36.8℃.

[0128] Related scale assessment: FAS fatigue rating scale: 18 points, Pittsburgh Sleep Quality Index (PSQI): 12 points, VAS pain visual analogue scale: 2 points, Traditional Chinese Medicine Symptom Score: 15 points, MMSE scale: 28 points, Hamilton Depression Rating Scale (HAMD-17): 4 points.

[0129] When the patient came to the clinic, he felt tired, had poor sleep quality, and decreased physical strength. The tongue was pale red, the fur was white and greasy, and the pulse was thin. The four examinations combined with the TCM syndrome differentiation were lung spleen and kidney deficiency syndrome, and the patient was given spleen and lung invigorating, kidney and consolidating Chinese medicine, and treated with the granules prepared in Example 1. 1 pack / time, 2 times / day, for 14 days.

[0130] After 14 days of treatment, the following indicators were reviewed: blood pressure: 149 / 96 mmHg, heart rate: 80 beats / min, respiration: 20 times / min, body temperature: 36.1°C. The patient's symptoms of general fatigue, sore waist and knees, cough and sputum, dry mouth and throat were significantly improved.

[0131] Related scales: FAS fatigue rating scale: 13 points, Pittsburgh sleep quality index (PSQI): 6 points, VAS pain visual analog scale: 0 points, TCM symptom score: 2 points, MMSE scale: 30 points, Hamilton depression rating scale (HAMD-17): 2 points. After treatment, no obvious abnormalities were found in the three routine tests, liver and kidney function, and electrocardiogram.

[0132] After treatment with the granules prepared in Example 1, the patient's FAS fatigue rating scale, Pittsburgh Sleep Quality Index (PSQI) and TCM symptom scores were significantly reduced.

[0133] Clinical Case 5

[0134] E, female, 31 years old;

[0135] The patient came to the hospital for treatment due to recovery from novel coronavirus infection (general fatigue) and was given the granules prepared in Example 1 for treatment for 14 days.

[0136] Diagnosis: Recovery from COVID-19 infection

[0137] Current symptoms: Patients complain of frequent fatigue, lack of energy, and shortness of breath when doing housework or climbing stairs.

[0138] Concomitant diseases: None.

[0139] The relevant examinations showed: COVID-19 antibody IgG 195.42S / CO. Blood pressure: 117 / 76mmHg, heart rate: 86 times / min, respiration: 21 times / min, body temperature: 36.3℃.

[0140] Related scale assessment: FAS fatigue rating scale: 16 points, Pittsburgh Sleep Quality Index (PSQI): 4 points, VAS pain visual analogue scale: 0 points, Traditional Chinese Medicine Symptom Score: 24 points, MMSE scale: 30 points, Hamilton Depression Rating Scale (HAMD-17): 0 points.

[0141] When the patient came to the clinic, he was tired, weak, and short of breath. The tongue was pale red, the fur was thin and white, and the pulse was stringy. The four examinations combined with the TCM syndrome differentiation were lung spleen and kidney deficiency syndrome, and the patient was given a Chinese medicine for strengthening the spleen and lungs, tonifying the kidney and consolidating the essence, and treated with the granules prepared in Example 1. 1 pack / time, 2 times / day, for 14 days.

[0142] After 14 days of treatment, the following indicators were reviewed: blood pressure: 106 / 71 mmHg, heart rate: 73 beats / min, respiration: 20 times / min, body temperature: 36.6°C. The patient's general fatigue, shortness of breath and other symptoms were significantly improved.

[0143] Related scales: FAS fatigue rating scale: 16 points, Pittsburgh sleep quality index (PSQI): 5 points, VAS pain visual analog scale: 0 points, TCM symptom score: 0 points, MMSE scale: 30 points, Hamilton depression rating scale (HAMD-17): 0 points. After treatment, no obvious abnormalities were found in the three routine tests, liver and kidney function, and electrocardiogram.

[0144] After treatment with the granules prepared in Example 1, the TCM symptom score of the patient was significantly reduced.

[0145] Clinical Case 6

[0146] F, female, 41 years old;

[0147] The patient came to the hospital for treatment due to the recovery period of novel coronavirus infection (fatigue and weakness), and was given the granules prepared in Example 1 for treatment, with a course of 14 days.

[0148] Diagnosis: Recovery from COVID-19 infection

[0149] Current symptoms: The patient complains of general fatigue, occasional dry cough, occasional sweating, the degree of which is relatively mild, and a sense of decreased physical strength and shortness of breath after work.

[0150] Concomitant diseases: None.

[0151] The relevant examinations showed: COVID-19 antibody IgG 165.89S / CO. Blood pressure: 118 / 78mmHg, heart rate: 90 times / min, respiration: 20 times / min, body temperature: 36.3℃.

[0152] Related scale assessment: FAS fatigue rating scale: 24 points, Pittsburgh Sleep Quality Index (PSQI): 3 points, VAS pain visual analogue scale: 0 points, Traditional Chinese Medicine Symptom Score: 8 points, MMSE scale: 30 points, Hamilton Depression Rating Scale (HAMD-17): 0 points.

[0153] When the patient came to the clinic, he felt tired, coughed with little sputum, and lacked energy. The tongue was red, the fur was thin, and the pulse was rapid. The four examinations combined with the TCM syndrome differentiation were lung spleen and kidney deficiency syndrome, and the patient was given a Chinese medicine for strengthening the spleen and lungs, tonifying the kidney and consolidating the essence, and treated with the granules prepared in Example 1. 1 pack / time, 2 times / day, for 14 days.

[0154] After 14 days of treatment, the following indicators were reviewed: blood pressure: 132 / 76 mmHg, heart rate: 98 beats / min, respiration: 19 times / min, body temperature: 36.3°C. The patient's general fatigue, soreness, insomnia and other symptoms were significantly improved.

[0155] Related scales: FAS fatigue rating scale: 17 points, Pittsburgh sleep quality index (PSQI): 2 points, VAS pain visual analog scale: 0 points, TCM symptom score: 0 points, MMSE scale: 30 points, Hamilton depression rating scale (HAMD-17): 0 points. After treatment, no obvious abnormalities were found in the three routine tests, liver and kidney function, and electrocardiogram.

[0156] After treatment with the granules prepared in Example 1, the patient's FAS fatigue rating scale and TCM symptom scores were significantly reduced.

[0157] Clinical Case 7

[0158] G, female, 38 years old;

[0159] The patient came to the clinic due to recovery from COVID-19 infection (body aches and pains) and was given the granules prepared in Example 1 for a course of 14 days.

[0160] Diagnosis: Recovery from COVID-19 infection

[0161] Current symptoms: The patient complains of occasional fatigue, lack of energy, easy awakening at night, excessive sweating, and feeling that his physical strength is not as good as before the illness, with a significant decrease in taste; occasional anxiety, depression, low mood, etc.; decreased physical strength; and a slight decrease in attention.

[0162] Concomitant diseases: None.

[0163] The relevant examinations showed: COVID-19 antibody IgG 16.7S / CO. Blood pressure: 113 / 72mmHg, heart rate: 98 times / min, respiration: 20 times / min, body temperature: 36.3℃.

[0164] Related scale assessment: FAS fatigue rating scale: 15 points, Pittsburgh Sleep Quality Index (PSQI): 7 points, VAS pain visual analogue scale: 0 points, Traditional Chinese Medicine symptom score: 10 points, MMSE scale: 30 points, Hamilton Depression Rating Scale (HAMD-17): 9 points.

[0165] When the patient came to the clinic, he felt obvious fatigue, poor sleep quality, lack of energy, and occasional anxiety. The tongue was red, the fur was thin, and the pulse was stringy. The four examinations combined with the TCM syndrome differentiation were lung spleen and kidney deficiency syndrome, and the patient was given a Chinese medicine for strengthening the spleen and lungs, tonifying the kidney and consolidating the essence, and treated with the granules prepared in Example 1. 1 pack / time, 2 times / day, for 14 days.

[0166] After 14 days of treatment, the following indicators were reviewed: blood pressure: 95 / 65 mmHg, heart rate: 110 beats / min, respiration: 19 times / min, body temperature: 36.3°C. The patient's symptoms of fatigue, sweating, anxiety and depression were significantly improved.

[0167] Related scales: FAS fatigue rating scale: 10 points, Pittsburgh sleep quality index (PSQI): 3 points, VAS pain visual analog scale: 0 points, TCM symptom score: 0 points, MMSE scale: 30 points, Hamilton depression rating scale (HAMD-17): 0 points. After treatment, no obvious abnormalities were found in the three routine tests, liver and kidney function, and electrocardiogram.

[0168] After treatment with the granules prepared in Example 1, the patient's FAS fatigue rating scale, Pittsburgh Sleep Quality Index (PSQI), Traditional Chinese Medicine symptoms and Hamilton Depression Rating Scale (HAMD-17) scores were significantly reduced.

[0169] Clinical Case 8

[0170] H, female, 70 years old;

[0171] The patient came to the clinic due to recovery from COVID-19 infection (body aches and pains), and was given the granules prepared in Example 1 for a course of 14 days.

[0172] Diagnosis: Recovery from COVID-19 infection

[0173] Current symptoms: Patients complain of fatigue, cough and sputum; insomnia, waking up easily at night, and difficulty falling asleep after waking up; occasional body aches and a sense of lack of energy; severe tinnitus symptoms.

[0174] Concomitant diseases: None.

[0175] The relevant examinations showed: COVID-19 antibody IgG 44.49S / CO. Blood pressure: 127 / 80mmHg, heart rate: 84 times / min, respiration: 21 times / min, body temperature: 36.4℃.

[0176] Related scale assessment: FAS fatigue rating scale: 20 points, Pittsburgh Sleep Quality Index (PSQI): 10 points, VAS pain visual analogue scale: 4 points, Traditional Chinese Medicine Symptom Score: 13 points, MMSE scale: 30 points, Hamilton Depression Rating Scale (HAMD-17): 0 points.

[0177] When the patient came to the clinic, he complained of fatigue, occasional cough, and excessive sputum; tinnitus was severe. The tongue was pale red, the coating was thick and greasy, and the pulse was thin. The four examinations combined with the TCM syndrome differentiation were lung spleen and kidney deficiency syndrome, and the patient was given a Chinese medicine for strengthening the spleen and lungs, tonifying the kidney and consolidating the essence, and treated with the granules prepared in Example 1. 1 pack / time, 2 times / day, for 14 days.

[0178] After 14 days of treatment, the following indicators were reviewed: blood pressure: 128 / 83 mmHg, heart rate: 72 beats / min, respiration: 19 times / min, body temperature: 36.0°C. The patient's symptoms such as tinnitus and shortness of breath were significantly improved.

[0179] Related scales: FAS fatigue rating scale: 22 points, Pittsburgh sleep quality index (PSQI): 7 points, VAS pain visual analog scale: 0 points, TCM symptom score: 6 points, MMSE scale: 29 points, Hamilton depression rating scale (HAMD-17): 0 points. After treatment, no obvious abnormalities were found in the three routine tests, liver and kidney function, and electrocardiogram.

[0180] After treatment with the granules prepared in Example 1, the TCM symptom score of the patient was significantly reduced.

[0181] Clinical Case 9

[0182] I, female, 50 years old;

[0183] The patient came to the hospital for treatment due to recovery from COVID-19 infection (fatigue, anxiety, and palpitations), and was given the granules prepared in Example 1 for treatment for 14 days.

[0184] Diagnosis: Recovery from COVID-19 infection

[0185] Current symptoms: Patients often feel tired and weak, occasionally cough and produce sputum, are prone to insomnia, easily wake up at night, have poor sleep quality, sweat when moving, feel a decrease in taste and smell, are in a low mood, often feel anxious and depressed, occasionally have palpitations, hearing loss, occasional tinnitus, and mild diarrhea.

[0186] Concomitant diseases: None.

[0187] The relevant examinations showed: COVID-19 antibody IgG 88.09S / CO. Blood pressure: 110 / 66mmHg, heart rate: 71 times / min, respiration: 23 times / min, body temperature: 36.0℃.

[0188] Related scale assessment: FAS fatigue rating scale: 30 points, Pittsburgh Sleep Quality Index (PSQI): 16 points, VAS pain visual analogue scale: 1 point, Traditional Chinese Medicine symptom score: 14 points, MMSE scale: 29 points, Hamilton Depression Rating Scale (HAMD-17): 23 points.

[0189] When the patient came to the clinic, he complained of fatigue, cough and sputum; insomnia and easy awakening; anxiety and depression; palpitations. The tongue was pale red, the coating was thick and greasy, and the pulse was thin. The four examinations combined with the TCM syndrome differentiation were lung spleen and kidney deficiency syndrome, and the Chinese medicine for strengthening the spleen and lung, tonifying the kidney and consolidating the essence was given, and the granules prepared in Example 1 were used for treatment. 1 pack / time, 2 times / day, for 14 days.

[0190] After 14 days of treatment, the following indicators were reviewed: blood pressure: 111 / 58 mmHg, heart rate: 74 beats / min, respiration: 20 times / min, body temperature: 36.3°C. The patient's insomnia, tinnitus and other symptoms were significantly improved.

[0191] Related scales: FAS fatigue rating scale: 10 points, Pittsburgh sleep quality index (PSQI): 11 points, VAS pain visual analog scale: 0 points, TCM symptom score: 4 points, MMSE scale: 30 points, Hamilton depression rating scale (HAMD-17): 3 points. After treatment, no obvious abnormalities were found in the three routine tests, liver and kidney function, and electrocardiogram.

[0192] After treatment with the granules prepared in Example 1, the patients' FAS fatigue rating scale, Pittsburgh sleep quality index (PSQI) scale, traditional Chinese medicine symptom score, and Hamilton depression rating scale (HAMD-17) were significantly reduced.

[0193] Clinical Case 10

[0194] J, female, 38 years old;

[0195] The patient came to the hospital for treatment due to the recovery period of novel coronavirus infection (dizziness, tinnitus, fatigue and weakness), and was treated with the granules prepared in Example 1 for a course of 14 days.

[0196] Diagnosis: Recovery from COVID-19 infection

[0197] Current symptoms: Patients complain of feeling slightly tired and weak, waking up easily at night, sweating easily, feeling decreased physical strength, decreased appetite, loss of taste for food, occasional anxiety and depression, difficulty concentrating, decreased hearing, and occasional tinnitus.

[0198] Concomitant diseases: None.

[0199] The relevant examinations showed: COVID-19 antibody IgG 16.70S / CO. Blood pressure: 113 / 72mmHg, heart rate: 98 times / min, respiration: 20 times / min, body temperature: 36.3℃.

[0200] Related scale assessment: FAS fatigue rating scale: 15 points, Pittsburgh Sleep Quality Index (PSQI): 7 points, VAS pain visual analogue scale: 0 points, Traditional Chinese Medicine symptom score: 10 points, MMSE scale: 30 points, Hamilton Depression Rating Scale (HAMD-17): 9 points.

[0201] When the patient came to the clinic, he complained of fatigue, spontaneous sweating, aversion to wind, dizziness, tinnitus, shortness of breath. The tongue was pale red with tooth marks, thin white fur, and thin pulse. The four examinations combined with the TCM syndrome differentiation were lung spleen and kidney deficiency syndrome, and the patient was given a Chinese medicine for strengthening the spleen and lungs, tonifying the kidney and consolidating the essence, and treated with the granules prepared in Example 1. 1 pack / time, 2 times / day, for 14 days.

[0202] After 14 days of treatment, the following indicators were reviewed: blood pressure: 95 / 65 mmHg, heart rate: 110 beats / min, respiration: 19 times / min, body temperature: 36.3°C. The patient's symptoms such as tinnitus and shortness of breath were significantly improved.

[0203] Related scales: FAS fatigue rating scale: 10 points, Pittsburgh sleep quality index (PSQI): 3 points, VAS pain visual analog scale: 0 points, TCM symptom score: 0 points, MMSE scale: 30 points, Hamilton depression rating scale (HAMD-17): 0 points. After treatment, no obvious abnormalities were found in the three routine tests, liver and kidney function, and electrocardiogram.

[0204] After treatment with the granules prepared in Example 1, the patients' FAS fatigue rating scale, Pittsburgh sleep quality index (PSQI) scale, traditional Chinese medicine symptom score, and Hamilton depression rating scale (HAMD-17) were significantly reduced.

[0205] The above is only a preferred embodiment of the present invention and does not limit the present invention in any form. Therefore, any simple modification, equivalent change and modification made to the above embodiment according to the technical essence of the present invention without departing from the content of the technical solution of the present invention shall fall within the scope of protection of the technical solution of the present invention.

Claims

1. A Chinese medicine composition for the recovery period of novel coronavirus infection, characterized in that: The invention is prepared from the following raw materials in parts by weight: 3.5-5.5 parts of American ginseng, 6-9 parts of roasted astragalus, 3.5-5.5 parts of epimedium, 1-2 parts of notoginseng, 6-8 parts of yam, 4-6 parts of tuckahoe, 6-9 parts of raw rehmannia, 5-7 parts of lily, 3.5-5.5 parts of oriental water plantain, 1-2 parts of cinnamon bark, 6-9 parts of roasted malt, 2-4 parts of costusroot, 4-6 parts of anemarrhena and 2-4 parts of roasted liquorice.

2. The Chinese medicine composition according to claim 1, characterized in that: The invention is prepared from the following raw materials in parts by weight: 4.5 parts of American ginseng, 7.5 parts of roasted astragalus, 4.5 parts of epimedium, 1.5 parts of notoginseng, 7.5 parts of yam, 5 parts of poria, 7.5 parts of raw rehmannia, 6 parts of lily, 4.5 parts of oriental water plantain, 1.5 parts of cinnamon, 7.5 parts of roasted malt, 3 parts of costusroot, 4.5 parts of anemarrhena and 3 parts of roasted liquorice.

3. A Chinese medicine preparation for the recovery period of novel coronavirus infection, characterized in that: The invention comprises the Chinese medicine composition as claimed in claim 1 or 2 and auxiliary materials.

4. The Chinese medicine preparation according to claim 3, characterized in that: It is a granule.

5. A method for preparing the Chinese medicine preparation according to claim 3 or 4, characterized in that: The steps include: (1) boiling each raw material in the Chinese medicine composition according to claim 1 or 2 with water, and filtering to obtain a filtrate; (2) concentrating the filtrate to obtain a thick paste; (3) Dry the thick paste, add auxiliary materials, and then make granules.

6. The preparation method according to claim 5, characterized in that: Step (1) adopts a process of decocting twice.

7. The preparation method according to claim 5, characterized in that: Step (2) first performs a first concentration, then centrifuges, and then performs a second concentration to obtain a thick paste.

8. The preparation method according to claim 7, characterized in that: The first concentration to a concentrated solution with a relative density of 1.05 to 1.08, the relative density of which is tested at 60°C; The centrifugal speed is ≥7000rpm.

9. The preparation method according to claim 5, characterized in that: The auxiliary material in step (3) is dextrin, and the mass ratio of dry paste to dextrin is 50: (45-55); In the process of making granules, 87-88% ethanol is used as a wetting agent.

10. Use of the traditional Chinese medicine composition according to claim 1 or 2 in the preparation of a medicine for the recovery period of novel coronavirus infection.