CN113577211A

CN113577211A - Qibei body resistance strengthening granules and preparation method and application thereof

Info

Publication number: CN113577211A
Application number: CN202111018594.5A
Authority: CN
Inventors: 陈刚; 徐荣鹏; 高莉; 许文成; 殷涛; 陈喆
Original assignee: Individual
Current assignee: Individual
Priority date: 2021-09-01
Filing date: 2021-09-01
Publication date: 2021-11-02

Abstract

The invention provides Qibei body resistance strengthening particles and a preparation method and application thereof. The radix astragali and Bulbus Fritillariae Cirrhosae granule comprises radix astragali, radix Panacis Quinquefolii, radix Ophiopogonis, fructus Schisandrae chinensis, herba et Gemma Agrimoniae, folium Mori, semen Armeniacae amarum, fructus Trichosanthis, Bulbus Fritillariae Thunbergii, Trichosanthis radix, Bombyx Batryticatus, radix Platycodi, Poria, pericarpium Citri Tangerinae, Eupolyphaga Seu Steleophaga, cimicifugae rhizoma, bupleuri radix, rhizoma Polygoni Cuspidati, radix Glycyrrhizae Preparata, fructus Jujubae and fructus Tritici Levis. The Chinese medicinal preparation is designed for the convalescent stage of the novel coronavirus pneumonia, has the effects of supplementing qi and nourishing yin, strengthening body resistance and expelling toxin, helps patients to relieve symptoms, promotes stable transition of illness state, relieves sequelae, and reduces complications and adverse reactions.

Description

Qibei body resistance strengthening granules and preparation method and application thereof

Technical Field

The invention belongs to the field of traditional Chinese medicines, relates to a traditional Chinese medicine composition, and a preparation method and application thereof, and particularly relates to astragalus-fritillary body resistance strengthening particles, and a preparation method and application thereof.

Background

Viral exogenous febrile disease is commonly seen in influenza, acute suppurative tonsillitis and acute upper respiratory tract infection in modern medicine, has the characteristics of acute and serious illness, and the like, and is clinically manifested as fire-heat inflammation and hyperactivity of fire-heat symptoms such as high fever, red face and eyes, thirst with water, restlessness, constipation, dark urine, red tongue with yellow coating, rapid pulse and the like, and the symptoms of yin injury or inward invasion and degeneration caused by fire easily occur in the course of disease, and the critical adverse symptoms such as wind, bleeding and orifice blockage appear. The severe diseases include epidemic cerebrospinal meningitis, epidemic encephalitis B, epidemic hemorrhagic fever, toxic pneumonia, septicemia and the like. The typhoid and epidemic febrile diseases called by traditional Chinese medicine belong to the category of exogenous febrile diseases.

The new coronavirus pneumonia (Corona Virus Disease 2019, COVID-19) is called new coronavirus pneumonia for short, and is pneumonia caused by new coronavirus infection. The clinical manifestations of patients with pneumonia infected by the novel coronavirus are: the symptoms of fever, hypodynamia and dry cough are mainly manifested, and symptoms of upper respiratory tract such as nasal obstruction, watery nasal discharge and the like are rare, and the hypoxia and hypoxia state can occur. Approximately half of patients develop dyspnea after one week, and severe patients rapidly progress to acute respiratory distress syndrome, septic shock, refractory metabolic acidosis, and procoagulant dysfunction.

It is noted that the severe and critically ill patients may have moderate or low fever during their course, even without significant fever. Some patients have slight onset symptoms, but no fever, and recover after a week. The prognosis is good for most patients, and the disease is critical or even death for a few patients. The discharge criteria for new coronary pneumonia were negative for pharyngeal swab examination twice, no symptoms, normal body temperature, and normal CT followed by two weeks of isolation. The patient can be treated or recovered properly for the convalescent period of people who release the isolation and reach the discharge standard, so as to prevent the disease from repeating and reduce the harmful effect of the disease on the patient.

Traditional Chinese medicine accumulates abundant experience in treating viral exogenous febrile diseases, and the predecessors have left tens of thousands of prescriptions for treating various viral exogenous febrile diseases and a large number of documents recording the function and action of related medicines. The traditional Chinese medicine for treating viral exogenous febrile disease has the following advantages:

the effectiveness and safety of the traditional Chinese medicine for treating viral exogenous febrile disease are improved. The research in recent decades proves that the traditional Chinese medicine has definite curative effect on viral exogenous febrile diseases, and has great safety in the administration process because the traditional Chinese medicine is mainly natural medicine and is mostly used in a compound form, and the traditional Chinese medicine can play the roles of synergism and attenuation.

Secondly, the traditional Chinese medicine has better overall effect of treating viral exogenous febrile disease. The traditional Chinese medicine generally starts from integral adjustment when treating viral exogenous febrile diseases, plays a role in treatment by directly or indirectly killing pathogens, adjusting functions of an immune system, protecting an organism and reducing diseases and damage and the like, has the functions of multiple directions and multiple targets, often has the advantages that western medicines do not have, can block the course of disease, reduce symptoms, shorten the heating time and the hospitalization time, promote stable transition of the disease, reduce sequelae and reduce complications and adverse reactions of the western medicines. The combination of traditional Chinese medicine and western medicine can effectively integrate medical resources, reduce the death rate, reduce complications and reduce medical expenses.

Therefore, the traditional Chinese medicine composition for treating viral exogenous febrile disease, especially novel coronavirus pneumonia, has important clinical significance for preventing disease repetition and improving the resistance of patients.

Disclosure of Invention

Aiming at the defects in the prior art, the invention aims to provide astragalus-fritillary strengthening particles and a preparation method and application thereof. The Qibei body resistance strengthening granule has the effects of tonifying qi and yin, strengthening body resistance and expelling toxin, is set for the convalescent period of the new coronary pneumonia, and is specially used for patients with incomplete remaining evil and deficient body resistance in the convalescent period.

In order to achieve the purpose, the invention adopts the following technical scheme:

in a first aspect, the present invention provides a qi bei zheng granule, which is prepared from the following raw materials: radix astragali, radix Panacis Quinquefolii, radix Ophiopogonis, fructus Schisandrae chinensis, herba et Gemma Agrimoniae, folium Mori, semen Armeniacae amarum, fructus Trichosanthis, Bulbus Fritillariae Thunbergii, Trichosanthis radix, Bombyx Batryticatus, radix Platycodi, Poria, pericarpium Citri Tangerinae, Eupolyphaga Seu Steleophaga, cimicifugae rhizoma, bupleuri radix, rhizoma Polygoni Cuspidati, radix Glycyrrhizae Preparata, fructus Jujubae, and fructus Tritici Levis.

In the invention, the Qibei body resistance strengthening particles are arranged for the recovery period of the novel coronavirus pneumonia, the novel coronavirus pneumonia belongs to damp-heat pathogenic qi in traditional Chinese medicine, the damp-heat fetters the lung for a long time, the lung qi is greatly consumed, and the lung fluid is scorched, so that the astragalus, the American ginseng, the dwarf lilyturf tuber, the Chinese magnoliavine fruit and the hairyvein agrimony are used for tonifying the lung, supplementing qi and nourishing yin; meanwhile, the dampness and heat are steamed to turn into sticky phlegm and cough but not discharge, so the mulberry leaves are used for diffusing the lung, the almonds are used for lowering the lung, the snakegourd fruits, the thunberg fritillary bulbs and the trichosanthes roots are used for moistening the lung for eliminating phlegm, the stiff silkworms are used for eliminating stubborn phlegm, the platycodon roots are used for extracting lung qi, and the poria cocos is used for tonifying the spleen and removing dampness to eliminate phlegm as a source;

in addition, phlegm is the pathogenic factors of the body type, which can obstruct qi movement, and qi stagnation can lead to blood stasis, so it uses Chen Pi to move qi and Eupolyphaga Seu Steleophaga to activate blood; for damp-heat pathogen deeply lodged in the lung to form phlegm-phlegm embolism to wrap virus and cause yang recovery, Cimicifuga rhizome and Bupleurum root are used in combination with Astragalus root to expel toxin; the lung and the large intestine are exterior and interior to each other, so that the large intestine is communicated to facilitate the discharge of pathogenic qi in the lung, so the giant knotweed rhizome is used for slowly communicating the stool; considering that the patient has a long isolation period, fear in mind and low emotion, the emotion is relieved by the honey-fried licorice root, the Chinese date and the light wheat.

The Qibei body resistance strengthening granules provided by the invention start from integral adjustment, block the course of disease, relieve symptoms, shorten the fever time and the hospitalization time, promote the stable transition of the disease, relieve sequelae and reduce complications and adverse reactions.

It should be noted that the qi-bei body resistance strengthening granules in the present invention can exist in the form of granules, and the rest of the medicines including the decoction, pill, capsule and other dosage forms of the above traditional Chinese medicine formula are also within the protection scope of the present invention.

Preferably, the raw materials for preparing the Qibei Fuzheng granules comprise the components shown in the table 1 in parts by weight:

TABLE 1

In the invention, the astragalus has the functions of tonifying qi, tonifying lung and nourishing heart, and the weight parts can be 5 parts, 6 parts, 8 parts, 10 parts, 12 parts, 15 parts, 16 parts, 18 parts, 20 parts, 22 parts, 24 parts, 25 parts, 28 parts or 30 parts and the like.

The American ginseng can tonify qi and nourish yin, clear heat and promote fluid production, and the weight parts of the American ginseng can be 5 parts, 6 parts, 8 parts, 10 parts, 12 parts, 15 parts, 16 parts, 18 parts or 20 parts and the like.

The radix ophiopogonis can nourish yin, promote the production of body fluid, moisten lung and clear away heart-fire, and the weight parts of the radix ophiopogonis can be 5 parts, 6 parts, 8 parts, 10 parts, 12 parts, 15 parts, 16 parts, 18 parts or 20 parts and the like.

The schisandra fruit can astringe lung, nourish kidney, promote the production of body fluid, absorb sweat and astringe essence, and the weight portions of the schisandra fruit can be 5 portions, 6 portions, 8 portions, 10 portions, 12 portions, 15 portions, 16 portions, 18 portions or 20 portions, etc.

The agrimony can astringe to stop bleeding, check malaria, stop dysentery and detoxify, is commonly used for hemoptysis, hematemesis, nosebleed, malaria, debilitation and carbuncle swelling and the like, and can be 5 parts, 6 parts, 8 parts, 10 parts, 12 parts, 15 parts, 16 parts, 18 parts, 20 parts, 22 parts, 24 parts, 25 parts, 28 parts or 30 parts by weight.

The mulberry leaves can disperse wind and heat, clear away the lung-heat and moisten dryness, calm the liver and improve eyesight, cool blood and stop bleeding; the weight portion can be 5, 6, 8, 10, 12, 15, 16, 18 or 20 portions.

The almond can relieve cough and asthma and relax bowel, and the weight portion of the almond can be 5 portions, 6 portions, 8 portions, 10 portions, 12 portions, 15 portions, 16 portions, 18 portions or 20 portions, etc.

The snakegourd fruit is used for clearing heat and reducing phlegm, relieving chest stuffiness and resolving masses and relaxing bowel, and can be 5 parts, 6 parts, 8 parts, 10 parts, 12 parts, 15 parts, 16 parts, 18 parts, 20 parts, 21 parts, 22 parts, 24 parts or 25 parts by weight and the like.

The thunberg fritillary bulb can clear heat, resolve phlegm, relieve depression and dissipate stagnation, and the weight portion of the thunberg fritillary bulb can be 5 portions, 6 portions, 8 portions, 10 portions, 12 portions, 15 portions, 16 portions, 18 portions or 20 portions.

Trichosanthis radix has effects of clearing heat-fire, promoting fluid production to quench thirst, detumescence and expelling pus, and can be used for treating fever polydipsia, lung heat dry cough, internal heat diabetes, pyocutaneous disease and pyogenic infections; the weight portion can be 5, 6, 8, 10, 12, 15, 16, 18 or 20 portions.

The stiff silkworm can extinguish wind and stop spasm, dispel wind and relieve pain, and reduce phlegm and dissipate stagnation, and the weight parts of the stiff silkworm can be 5 parts, 6 parts, 8 parts, 10 parts, 12 parts, 15 parts, 16 parts, 18 parts or 20 parts, and the like.

The platycodon grandiflorum has the functions of dispersing lung and relieving sore throat, and eliminating phlegm and discharging pus, and the weight parts of the platycodon grandiflorum can be 5 parts, 6 parts, 8 parts, 10 parts, 12 parts, 15 parts, 16 parts, 18 parts or 20 parts, and the like.

The tuckahoe can promote diuresis, eliminate dampness, invigorate spleen and calm heart, and the weight portions of the tuckahoe can be 5, 6, 8, 10, 12, 15, 16, 18 or 20 portions.

The dried orange peel can regulate qi, invigorate spleen, dry dampness and resolve phlegm, and the weight portions can be 5, 6, 8, 10, 12, 15, 16, 18 or 20 portions.

The ground beetle is used for breaking blood and removing stasis and setting the sinew and bone, and the weight portions of the ground beetle can be 5 portions, 6 portions, 8 portions, 10 portions, 12 portions, 15 portions, 16 portions, 18 portions or 20 portions, etc.

Cimicifugae foetidae can release exterior and promote eruption, clear away heat and toxic material, and raise yang and lift sinking, and the parts by weight of the cimicifugae foetidae can be 3, 4, 5, 6, 7, 8, 9 or 10 parts and the like.

The bupleurum root, radix bupleuri, radix bupleuri, radix bupleuri, radix bupleuri, radix bupleuri, radix bupleuri, radix bupleuri, radix bupleuri, radix.

The giant knotweed rhizome has the functions of dispelling wind and promoting diuresis, eliminating stasis and relieving pain, relieving cough and reducing sputum, and the weight portions of the giant knotweed rhizome can be 5 portions, 6 portions, 8 portions, 10 portions, 12 portions, 15 portions, 16 portions, 18 portions, 20 portions, 21 portions, 22 portions, 24 portions or 25 portions, etc.

Prepared licorice root, radix Glycyrrhizae Praeparata, in parts by weight, is capable of tonifying spleen and qi, eliminating phlegm and stopping cough, and harmonizing the effects of the medicines, such as 5 parts, 6 parts, 8 parts, 10 parts, 12 parts, 15 parts, 16 parts, 18 parts or 20 parts.

The Chinese date has the functions of strengthening the middle-jiao and replenishing qi, and nourishing blood and tranquilization, and the weight portions of the Chinese date can be 5 portions, 6 portions, 8 portions, 10 portions, 12 portions, 15 portions, 16 portions, 18 portions or 20 portions, etc.

The light wheat can strengthen superficial resistance, stop sweating, tonify qi and remove heat, and the weight portion can be 5 portions, 6 portions, 8 portions, 10 portions, 12 portions, 15 portions, 16 portions, 18 portions, 20 portions, 22 portions, 24 portions, 25 portions, 28 portions or 30 portions, etc.

In a preferred embodiment of the present invention, the astragalus membranaceus is 20 to 30 parts by weight (e.g., 20 parts, 21 parts, 22 parts, 23 parts, 24 parts, 25 parts, 26 parts, 27 parts, 28 parts, 29 parts, or 30 parts), the agrimonia pilosa is 20 to 30 parts by weight (e.g., 20 parts, 21 parts, 22 parts, 23 parts, 24 parts, 25 parts, 26 parts, 27 parts, 28 parts, 29 parts, or 30 parts), and the blighted wheat is 20 to 30 parts by weight (e.g., 20 parts, 21 parts, 22 parts, 23 parts, 24 parts, 25 parts, 26 parts, 27 parts, 28 parts, 29 parts, or 30 parts).

Preferably, the weight part of the whole snakegourd fruit is 10-20 parts (for example, 10 parts, 11 parts, 12 parts, 13 parts, 14 parts, 15 parts, 16 parts, 17 parts, 18 parts, 19 parts or 10 parts and the like), and the weight part of the giant knotweed rhizome is 15-25 parts (for example, 15 parts, 16 parts, 17 parts, 18 parts, 19 parts, 20 parts, 21 parts, 22 parts, 23 parts, 24 parts or 25 parts and the like).

Preferably, the cimicifuga foetida is 5 to 8 parts (e.g. 5 parts, 5.5 parts, 6 parts, 6.5 parts, 7 parts, 7.5 parts or 8 parts, etc.) by weight, and the bupleurum root is 5 to 8 parts (e.g. 5 parts, 5.5 parts, 6 parts, 6.5 parts, 7 parts, 7.5 parts or 8 parts, etc.).

As a preferable technical scheme of the invention, the raw materials for preparing the Qibei Fuzheng granules comprise the following components in parts by weight as shown in the following table 2:

TABLE 2

Components	Parts by weight/part	Components	Parts by weight/part	Components	Parts by weight/part
						Astragalus membranaceus	30	American ginseng	10	Ophiopogon japonicus	10
Schisandra chinensis	10	Agrimonia pilosa Ledeb	30	Mulberry Leaves	10
						Almond	10	Whole snakegourd fruit	20	Bulbus Fritillariae Thunbergii	10
Radix trichosanthis	10	Bombyx Batryticatus	10	Root of balloonflower	10
						Poria cocos (Schw.) wolf	10	Dried orange peel	10	Ground beetle	10
Cimicifugae foetidae	6	Radix bupleuri	6	Giant knotweed rhizome	15
						Prepared licorice root	10	Chinese date	10	Blighted wheat	30

Preferably, the astragalus-fritillary body resistance strengthening granules further comprise pharmaceutically acceptable auxiliary materials.

Preferably, the pharmaceutically acceptable auxiliary materials comprise any one or a combination of at least two of a binding agent, an antistaling agent, a flavoring agent or a disintegrating agent.

In a second aspect, the present invention also provides a preparation method of the qi-bei body resistance strengthening granule as described in the first aspect, the preparation method comprising:

mixing the components in the formula, adding water, decocting to obtain a decoction, filtering, concentrating to obtain an extract, and granulating the extract to obtain the Qibei body resistance strengthening granules.

As a preferred technical scheme of the invention, the method also comprises the step of grinding the components in the formula into powder before mixing.

Preferably, the number of times of decocting with water is 1-3 (for example, 1, 2 or 3 times), and the time of decocting with water for each time is 30 min-100 min, for example, 30min, 40min, 50min, 60min, 70min, 80min, 90min or 100min, etc.

Preferably, the concentration is to concentrate the obtained filtrate into an extract with a relative density of 1.30-1.35 (for example, 1.30, 1.31, 1.32, 1.33, 1.34 or 1.35);

preferably, the granulation method comprises: mixing the extract with binder, kneading, sieving, and drying to obtain granule.

Preferably, the binder comprises any one or a combination of at least two of sucrose, dextrin or starch.

As a preferred technical scheme of the invention, the preparation method comprises the following steps:

(1) mixing astragalus, American ginseng, dwarf lilyturf tuber, Chinese magnoliavine fruit, hairyvein agrimony, mulberry leaf, almond, snakegourd fruit, thunberg fritillary bulb, mongolian snakegourd root, stiff silkworm, platycodon root, Indian buead, tangerine peel, ground beeltle, largetrifolioliolious bugbane rhizome, Chinese thorowax root, giant knotweed rhizome, honey-fried licorice root, Chinese date and light wheat according to a formula amount, and adding water for decocting for 3 times, wherein the decocting time is 30-100 min each time;

(2) and combining the obtained decoctions, filtering, concentrating the filtrate into an extract with the relative density of 1.30-1.35, adding an adhesive, kneading, sieving, drying, and preparing the astragalus-fritillary body resistance strengthening granules.

In a third aspect, the invention provides the use of the astragalus-fritillary strengthening granules in the first aspect in preparing a medicine for treating exogenous febrile disease.

Preferably, the exogenous fever includes a novel coronary pneumonia.

The recitation of numerical ranges herein includes not only the above-recited values, but also any values between any of the above-recited numerical ranges not recited, and for brevity and clarity, is not intended to be exhaustive of the specific values encompassed within the range.

Compared with the prior art, the invention has the beneficial effects that:

the Qibei body resistance strengthening granules are used for treating the convalescent stage of the new coronary pneumonia, and have the effects of supplementing qi and nourishing yin, strengthening body resistance and expelling toxin. Wherein, the astragalus, the American ginseng, the dwarf lilyturf tuber, the Chinese magnoliavine fruit and the hairyvein agrimonia herb tonify the lung, tonify qi and nourish yin, and are mainly used for treating that damp-heat evil qi is chronically confined in the lung, the lung qi is greatly consumed and the lung fluid is burned; the mulberry leaf is used for ventilating the lung, the almond is used for lowering the lung, the snakegourd fruit, the thunberg fritillary bulb and the mongolian snakegourd root are used for moistening the lung and reducing phlegm, the stiff silkworm is used for dissolving stubborn phlegm, the platycodon grandiflorum is used for expelling lung qi, and the poria cocos is used for tonifying spleen and removing dampness, so that the source of phlegm is removed, and the main treatment is that damp-heat is evaporated, the phlegm is converted into sticky phlegm and the cough cannot be produced; pericarpium Citri Tangerinae is used for promoting circulation of qi, Eupolyphaga Seu Steleophaga is used for promoting blood circulation, cimicifugae rhizoma and bupleuri radix are used together with radix astragali for expelling toxin, rhizoma Polygoni Cuspidati is used for relieving constipation, and radix Glycyrrhizae Preparata, fructus Jujubae and fructus Tritici Levis are used for relieving emotion; the components in the Qibei body resistance strengthening granule cooperate with each other, so that the clinical symptoms of patients in the convalescent period of exogenous febrile diseases represented by new coronary pneumonia can be improved, and medical help is provided for the rehabilitation of the patients.

Meanwhile, the preparation method of the Qibei body resistance strengthening granules provided by the invention can fully extract the effective components in the raw materials and ensure the drug effect of the raw materials, and the traditional Chinese medicine composition is prepared into the granules by the method, so that the granules are more convenient for patients to take.

Detailed Description

The technical solution of the present invention is further explained by the following embodiments. It should be understood by those skilled in the art that the examples are only for the understanding of the present invention and should not be construed as the specific limitations of the present invention.

The following examples do not specify particular techniques or conditions, according to the techniques or conditions described in the literature in the field, or according to the product specifications.

The reagents and instruments used in the following examples are not indicated by manufacturers, and are all conventional products commercially available from normal sources.

Example 1

The embodiment provides Qibei body resistance strengthening granules, which comprise the following components in percentage by weight as shown in the following table 3:

TABLE 3

The preparation method of the Qibei body resistance strengthening granules comprises the following steps:

(1) mixing the above Chinese medicinal materials according to formula ratio, decocting in water for 3 times, each time for 60 min;

(2) mixing the obtained decoctions, filtering, concentrating the filtrate to obtain extract with relative density of 1.35, adding sucrose 2g and dextrin 1g, kneading, sieving, and drying to obtain QIBEIFUZHENG granule.

Example 2

The embodiment provides Qibei body resistance strengthening granules, which comprise the following components in percentage by weight as shown in the following table 4:

TABLE 4

Components	Weight/g	Components	Weight/g	Components	Weight/g
						Astragalus membranaceus	20	American ginseng	10	Ophiopogon japonicus	10
Schisandra chinensis	10	Agrimonia pilosa Ledeb	20	Mulberry Leaves	10
						Almond	10	Whole snakegourd fruit	15	Bulbus Fritillariae Thunbergii	5
Radix trichosanthis	5	Bombyx Batryticatus	10	Root of balloonflower	10
						Poria cocos (Schw.) wolf	10	Dried orange peel	10	Ground beetle	10
Cimicifugae foetidae	3	Radix bupleuri	10	Giant knotweed rhizome	10
						Prepared licorice root	5	Chinese date	5	Blighted wheat	20

(1) mixing the above Chinese medicinal materials according to formula ratio, decocting in water for 2 times, each time for 80 min;

(2) mixing the obtained decoctions, filtering, concentrating the filtrate to obtain extract with relative density of 1.30, adding sucrose 1.5g and starch 1g, kneading, sieving, and drying to obtain QIBEIFUZHENG granule.

Example 3

The embodiment provides Qibei body resistance strengthening granules, which comprise the following components in the following table 5:

TABLE 5

Components	Weight/g	Components	Weight/g	Components	Weight/g
						Astragalus membranaceus	30	American ginseng	10	Ophiopogon japonicus	20
Schisandra chinensis	10	Agrimonia pilosa Ledeb	5	Mulberry Leaves	10
						Almond	10	Whole snakegourd fruit	15	Bulbus Fritillariae Thunbergii	5
Radix trichosanthis	5	Bombyx Batryticatus	20	Root of balloonflower	10
						Poria cocos (Schw.) wolf	20	Dried orange peel	10	Ground beetle	20
Cimicifugae foetidae	10	Radix bupleuri	3	Giant knotweed rhizome	10
						Prepared licorice root	5	Chinese date	5	Blighted wheat	30

(2) mixing the decoctions, and filtering to obtain QIBEIFENGZHENG decoction.

Evaluation of safety

The subjects were treated with the astragalus-bei strengthening granules prepared in example 1 for two weeks, with 10g each time, 3 times daily, and without other similar drugs.

During the course of treatment, the subject was observed for changes in the following indices, before and after treatment, respectively, including: the laboratory checks the routine of blood, urine and stool, the functions of liver and kidney and the incidence rate of adverse reactions.

1: routine blood examination

In this example, a total of 71 patients completed routine blood tests in and out of the group; among them, 28 patients with abnormal entry blood routine test and 27 patients with abnormal exit blood routine test.

Single patient contextual comparisons: statistical analysis is carried out on blood routine examination data of 71 patients with 8 patients with normal group entry blood routine indexes and abnormal group exit blood routine indexes, and the results are shown in the following table 6 by using a T test method:

TABLE 6

Paired sample test data are shown in table 7 below:

TABLE 7

As can be seen from the above table, the change P value of each group of examination indexes is not less than 0.05 before and after treatment, and the difference has no statistical significance; the qi-bei body resistance strengthening granule is considered to have no influence on the conventional blood indexes of patients.

2. Blood biochemical examination and analysis

In this example, 69 patients completed biochemical blood tests of group entry and group exit, wherein 10 patients were abnormal in biochemical blood test of group entry and 12 patients were abnormal in biochemical blood test of group exit.

Single patient contextual comparisons: the biochemical index of the incoming blood is normal, and the biochemical index of the outgoing blood is abnormal in 5 cases, the blood biochemical examination data of 69 patients are statistically analyzed, and the results are shown in the following table 8 by using a T test method:

TABLE 8

Paired sample test data is shown in table 9 below:

TABLE 9

As can be seen from the above table, the comparison P values before and after urea nitrogen in the biochemical indexes before and after treatment are all less than 0.05, and the difference has statistical significance. The average value of urea nitrogen after treatment is 5.21 in the normal range of the index, and the comparison difference between the other indexes has no statistical significance; the astragalus-fritillary body resistance strengthening granules are considered to have no adverse effect on the blood biochemical indexes of patients.

3. Routine examination and analysis of urine

In this example, a total of 67 patients completed routine urine examinations into and out of the group. Among them, 31 patients with abnormal test of group urine routine and 36 patients with abnormal test of group urine routine are selected.

Single patient contextual comparisons: the urine routine examination data of 67 patients were statistically analyzed for 11 patients with normal index of the entering urine and abnormal index of the exiting urine, and the results of the T test were shown in table 10 below:

watch 10

Paired sample test data are shown in table 11 below:

TABLE 11

As can be seen from the above table, the conventional indexes of urine P are all more than or equal to 0.05, and the difference has no statistical significance.

4. Convenient routine analysis

The routine examination of the patients in the group and the patients out of the group are completely completed by 15 patients, and the routine examination of the patients in the group and the patients out of the group of 15 patients has no abnormality.

Through the analysis of the blood routine, the urine routine, the stool routine and the liver and kidney functions, after the test subject takes the astragalus-fritillary body strengthening particles, various functions of the body of the test subject are not obviously affected, and the abnormal examination items in the experimental process can be caused by diseases or body differences of the test subject;

therefore, the safety evaluation experiment proves that the Qibei body resistance strengthening granules provided by the invention have the advantages that each component follows the compatibility principle of 'monarch, minister, assistant and guide', no obvious adverse reaction occurs, and the granules have higher safety for patients, particularly patients with deficiency of both qi and yin in the new coronary rehabilitation period.

Evaluation of traditional Chinese medicine syndromes

In order to further verify the treatment effect of the Qibei body resistance strengthening particles on patients in the new coronary rehabilitation period, 101 patients are taken as treatment objects in a performance test.

There were 12 total abscissions during the experiment, the reasons for abscission were: patient quit due to personal affair initiative, patient miss visit due to non-explanation reason or patient quit due to violation of experimental scheme, etc.

Subjects were treated with the astragalus-bei strengthening particles prepared in example 1 for two weeks, with 10g each, 3 times daily, and without other similar drugs. The clinical symptom change condition of the subject is observed according to the clinical research guiding principle of new traditional Chinese medicine based on the reduction percentage of the syndrome score.

The traditional Chinese medicine syndromes mainly observe major symptoms and minor symptoms, and specifically comprise:

the main symptoms are: cough, shortness of breath, weakness;

the secondary symptoms are as follows: no phlegm or little and sticky phlegm, sweating, dry mouth or throat, poor appetite, fullness and distention, loose stool or constipation, and the like, and the change of the qi-yin syndrome with unexhausted pathogenic factors;

according to the scoring of the clinical research guideline of new traditional Chinese medicine, the change of clinical symptoms is observed:

a. and (3) judging the curative effect of the main symptoms: cough, expectoration, shortness of breath and other symptoms.

The results are shown in table 12 below:

TABLE 12

Item	Disappearance (example)	Improvement (example)	Invalid (example)	Total effective rate
					Main index/person	2	74	13	85.4％

Wherein, disappearance: symptom disappeared, score 0;

improvement: symptom relief, score reduction, but not 0;

and (4) invalidation: symptoms were not reduced or exacerbated, and scores were not reduced.

As can be seen from the above table, after 2 weeks using the granules provided by the present invention, the principal symptoms of 2 patients disappeared, the principal symptoms of 76 patients improved, and the total effective rate was 85.7%.

b. Evaluation of traditional Chinese medicine syndrome therapeutic effect (integral ratio method)

The main outcome indexes of the clinical curative effect are analyzed, and the method specifically comprises the following steps:

and (3) clinical control: the integral improvement rate of the syndrome after treatment is more than or equal to 95 percent;

the effect is shown: the syndrome integral improvement rate after treatment is more than or equal to 70 percent and less than 95 percent;

improvement: the syndrome integral improvement rate after treatment is more than or equal to 30 percent and less than 70 percent;

and (4) invalidation: the improvement rate of the syndrome score after treatment is less than 30 percent.

In the test procedure, the qi bei body resistance strengthening granules are administered for two weeks, based on the percentage reduction of the syndrome score, and the results are shown in the following table 13:

watch 13

Time	Control rate/%)	Significant efficiency/%)	Effective rate%	Non efficiency/%)
					One week later	0	2.25	49.44	48.31
After two weeks	2.25	24.72	51.69	21.35

After the astragalus-fritillary body resistance strengthening particles are used for two weeks, the symptoms of patients are obviously relieved, the control rate, the significant efficiency and the effective rate can reach 78.66%, and the effect is better.

In conclusion, the astragalus-baibei body resistance strengthening granules comprise a plurality of natural medicines, can achieve the effects of synergism and attenuation, have higher safety in the medication process, and the components in the traditional Chinese medicine formula are cooperated to reduce the symptoms of patients, promote the stable transition of the state of an illness and reduce sequelae.

The applicant declares that the above description is only a specific embodiment of the present invention, but the scope of the present invention is not limited thereto, and it should be understood by those skilled in the art that any changes or substitutions that can be easily conceived by those skilled in the art within the technical scope of the present invention are within the scope and disclosure of the present invention.

Claims

1. The astragalus-fritillary body resistance strengthening particles are characterized by being prepared from the following raw materials:

radix astragali, radix Panacis Quinquefolii, radix Ophiopogonis, fructus Schisandrae chinensis, herba et Gemma Agrimoniae, folium Mori, semen Armeniacae amarum, fructus Trichosanthis, Bulbus Fritillariae Thunbergii, Trichosanthis radix, Bombyx Batryticatus, radix Platycodi, Poria, pericarpium Citri Tangerinae, Eupolyphaga Seu Steleophaga, cimicifugae rhizoma, bupleuri radix, rhizoma Polygoni Cuspidati, radix Glycyrrhizae Preparata, fructus Jujubae and fructus Tritici Levis.

2. The Qibei body resistance strengthening particle of claim 1, wherein the raw materials for preparing the Qibei body resistance strengthening particle comprise the following components in parts by weight:

3. the astragalus-fritillary body resistance strengthening granules as claimed in claim 1 or 2, wherein the astragalus membranaceus accounts for 20-30 parts by weight, the agrimony accounts for 20-30 parts by weight, and the blighted wheat accounts for 20-30 parts by weight;

preferably, the weight parts of the whole snakegourd fruit are 10-20 parts, and the weight parts of the giant knotweed rhizome are 15-25 parts;

preferably, the cimicifugae foetidae is 5-8 parts by weight, and the bupleurum is 5-8 parts by weight.

4. The Qibei body resistance strengthening particle as claimed in any one of claims 1 to 3, wherein the preparation raw materials of the Qibei body resistance strengthening particle comprise, by weight:

5. the Qibei body resistance strengthening particle according to any one of claims 1 to 4, further comprising a pharmaceutically acceptable excipient;

6. A method for preparing the Qibei body resistance strengthening particle as claimed in any one of claims 1 to 5, wherein the preparation method comprises the following steps:

7. The method of claim 6, further comprising the step of grinding the components of the formulation into a powder prior to mixing;

preferably, the number of times of water adding and decocting is 1-3, and the time of water adding and decocting each time is 30-100 min.

8. The method of claim 6 or 7, wherein the concentrating is: concentrating the obtained filtrate into an extract with the relative density of 1.30-1.35;

preferably, the granulation method comprises: mixing the extract with an adhesive, kneading, sieving, and drying to obtain granules;

9. The method according to any one of claims 6 to 8, characterized by comprising the steps of:

10. The use of the Qibei Fuzheng granule of any one of claims 1 to 5 in the preparation of a drug for treating exogenous febrile disease;

preferably, the exogenous fever includes a novel coronavirus pneumonia.