CN117244026A

CN117244026A - Vitex negundo clearing prescription and application

Info

Publication number: CN117244026A
Application number: CN202310415235.6A
Authority: CN
Inventors: 张炜; 徐贵华; 陈旋; 郑月娟; 孙萌; 刘瑾; 陈麒; 史苗颜; 张兴
Original assignee: Shuguang Hospital Affiliated to Shanghai University of TCM
Current assignee: Shuguang Hospital Affiliated to Shanghai University of TCM
Priority date: 2023-04-18
Filing date: 2023-04-18
Publication date: 2023-12-19

Abstract

The invention provides a Jingyin clearing prescription which is prepared from the following raw materials in parts by weight: 8-16 parts of honeysuckle, 5-13 parts of radix bupleuri, 5-13 parts of schizonepeta, 5-13 parts of fructus forsythiae, 5-13 parts of patchouli, 4-8 parts of ephedra, 20-40 parts of gypsum, 5-13 parts of radix scutellariae, 5-13 parts of bitter apricot kernel, 12-24 parts of wild buckwheat root, 5-13 parts of radix isatidis, 4-8 parts of mint, 11-19 parts of reed rhizome, 11-19 parts of raw coix seed, 5-13 parts of tree peony bark and 5-13 parts of raw liquorice. The invention also provides application of the traditional Chinese medicine composition. The advantages are that: the traditional Chinese medicine composition accords with the compatibility of monarch, minister, assistant and guide, and Jing Yinqing turns into a recipe, namely, heat toxin is cleared, defensive qi is treated simultaneously, defensive qi is led to be separated into half exterior and half interior, and pathogenic factors are outward and heat toxin is intercepted from entering the interior; secondly, resolving damp toxin, avoiding dirt, resolving turbidity, dispersing upward, harmonizing middle and penetrating downward, resolving damp toxin in the triple energizer; thirdly, removing stasis toxin, twisting disease, and preventing epidemic toxin further deeply; the three tubes are all in line, and the effects of dispelling wind, clearing heat, removing toxicity and relieving sore throat are achieved.

Description

Vitex negundo clearing prescription and application

[ field of technology ]

The invention relates to a Jingyinqinghua prescription and application thereof, in particular to a Chinese patent medicine prepared by taking Chinese herbal medicines as raw materials.

[ background Art ]

Respiratory infectious diseases refer to infectious diseases caused by invasion of pathogens from respiratory infections such as nasal cavities, throats, trachea and bronchi of human bodies. From ancient times, humans encountered numerous respiratory infections, some of which are particularly severe, with a tremendous impact on the production and life of humans.

Chinese patent document CN201710944565.9 discloses a traditional Chinese medicine composition for clearing plague and resisting virus, which is prepared from the following raw materials in parts by weight: 18-25 parts of rhizoma anemarrhenae, 10-15 parts of rhodiola rosea, 10-15 parts of liquorice, 15-25 parts of rehmannia, 15-25 parts of rheum officinale, 10-15 parts of roasted ephedra herb, 40-55 parts of radix isatidis, 15-25 parts of patchouli, 15-25 parts of mint, 40-60 parts of cordate houttuynia, 10-20 parts of grassleaf sweelflag rhizome, 20-30 parts of rhizoma dryopterygii, 10-15 parts of reed rhizome, 20-30 parts of fructus forsythiae, 40-60 parts of honeysuckle, 20-30 parts of dandelion, 45-50 parts of bunge corydalis herb, 10-20 parts of Chinese lobelia, 10-20 parts of radix curcumae, 10-20 parts of gypsum, 15-20 parts of fried bitter apricot seed, 15-20 parts of schizonepeta spike, 10-20 parts of radix sileris, 10-20 parts of radix bupleuri, 10-20 parts of perilla leaf, 30-35 parts of kudzuvine root, 10-20 parts of platycodon root and 15-30 parts of dahurian angelica root. Chinese patent CN201610812905.8 discloses a traditional Chinese medicine composition for treating exogenous fever and a preparation method thereof, wherein the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 10-25 g of honeysuckle, 10-32 g of dandelion, 10-18 g of dyers woad leaf, 10-16 g of kudzuvine root, 10-32 g of indigowoad root, 4-12 g of red paeony root, 3-12 g of Chinese thorowax root, 3-10 g of baical skullcap root, 5-12 g of largeleaf gentian root, 3-12 g of fineleaf schizonepeta herb, 9-16 g of lophatherum herb, 5-12 g of radish seed, 3-12 g of platycodon root, 3-12 g of bitter apricot seed, 3-12 g of stiff silkworm, 5-12 g of patchouli, 6-15 g of common anemarrhena rhizome, 3-8 g of grassleaf sweelflag rhizome, 3-12 g of turmeric root tuber and 6-16 g of weeping forsythiae capsule.

Shanghai market new coronavirus infection traditional Chinese medical science and technology expert consensus (2022 spring edition), shanghai journal of traditional Chinese medicine, 2022, 56 (7): 5-6 discloses a Jing Yinqing prescription for treating new crown infection, which is prepared from flos Lonicerae, herba Schizonepetae, fructus forsythiae, herba Ephedrae preparata, semen Armeniacae amarum, gypsum Fibrosum, bupleuri radix, scutellariae radix, rhizoma Fagopyri Dibotryis, radix Isatidis, herba Menthae, rhizoma Phragmitis, herba Agastaches, coicis semen, cortex moutan, and Glycyrrhrizae radix. The article was previously published by the applicant and does not disclose the dosage of the drug.

Such a traditional Chinese medicine composition for treating respiratory infectious diseases has many defects, such as excessive medicine taste, difficult material acquisition, high price and the like. Therefore, a medicine with obvious effect, moderate medicine taste and convenient preparation is needed.

[ invention ]

The invention aims at overcoming the defects in the prior art and provides a vitex silver clearing prescription.

It is a further object of the present invention to provide a use of the above medicament.

In order to achieve the above purpose, the technical scheme adopted by the invention is as follows:

a Jingyin clearing prescription is prepared from the following raw materials in parts by weight: 8-16 parts of honeysuckle, 5-13 parts of radix bupleuri, 5-13 parts of schizonepeta, 5-13 parts of fructus forsythiae, 5-13 parts of patchouli, 4-8 parts of ephedra, 20-40 parts of gypsum, 5-13 parts of radix scutellariae, 5-13 parts of bitter apricot kernel, 12-24 parts of wild buckwheat root, 5-13 parts of radix isatidis, 4-8 parts of mint, 11-19 parts of reed rhizome, 11-19 parts of raw coix seed, 5-13 parts of tree peony bark and 5-13 parts of raw liquorice.

Preferably, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 10-14 parts of honeysuckle, 7-11 parts of radix bupleuri, 7-11 parts of schizonepeta, 7-11 parts of fructus forsythiae, 7-11 parts of patchouli, 5-7 parts of herba ephedrae, 25-35 parts of gypsum, 7-11 parts of radix scutellariae, 7-11 parts of bitter apricot seed, 15-21 parts of wild buckwheat root, 7-11 parts of radix isatidis, 5-7 parts of mint, 13-17 parts of reed rhizome, 13-17 parts of raw coix seed, 7-11 parts of tree peony bark and 7-11 parts of raw liquorice.

More preferably, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 12 parts of honeysuckle, 9 parts of radix bupleuri, 9 parts of schizonepeta, 9 parts of weeping forsythia, 9 parts of patchouli, 6 parts of ephedra, 30 parts of gypsum, 9 parts of baikal skullcap root, 9 parts of bitter apricot seed, 18 parts of wild buckwheat root, 9 parts of radix isatidis, 6 parts of peppermint, 15 parts of reed rhizome, 15 parts of raw coix seed, 9 parts of moutan bark and 9 parts of raw liquorice.

Preferably, the medicament of the traditional Chinese medicine composition is granules, decoction, tablets, capsules, oral liquid, mixture or syrup.

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

the application of the traditional Chinese medicine composition in preparing medicines for treating respiratory infectious diseases.

The invention has the advantages that:

in the formula, the honeysuckle has aromatic smell, is light and dispersed, and can clear away heat and toxic materials and avoid dirt and remove turbid. Radix bupleuri is bitter, pungent and slightly cold, is good at relieving exterior syndrome and fever, penetrating pathogenic factors in half exterior and half interior, and dispelling qi stagnation. Honeysuckle flower and bupleurum root are used together to disperse pathogenic heat from the exterior and defensive part, and the interior is breathable and breathable, so they are used as principal drugs. Herba Schizonepetae is pungent and slightly warm, and has effects of relieving exterior syndrome and eliminating pathogenic factors, and assisting flos Lonicerae to open skin and hair for eliminating pathogenic factors. Lian Qiao is combined with jin Yin Hua to dispel wind-heat from outside and dispel heat from inside and relieve toxicity, so it is indicated for clearing heat and relieving sore throat. Herba Pogostemonis is pungent and warm in nature, and has the effects of dispersing exterior pathogens, eliminating dampness and toxic materials, and dispersing pungent and warm in nature without dryness-heat, eliminating dampness and turbid in nature, transporting spleen and stomach, and regulating middle energizer, and is an essential herb for eliminating dampness with aromatics. Ephedra, herba Ephedrae, with the pungent and warm nature, has the effects of dispersing lung qi, relieving asthma, relieving exterior syndrome and eliminating pathogenic factors. Gypsum, gypsum, a sweet and cold source, is used for clearing away lung heat and dispersing the pathogenic factors. Herba Ephedrae is combined with Gypsum Fibrosum, and has effects of warming and expelling cold, dispersing lung qi, relieving asthma without helping heat, and clearing lung heat without being cold. Bai Huang is bitter and cold in nature and good at clearing heat from upper energizer, combined with chai Hu, one of clearing heat, dispersing, and relieving exterior and interior heat. Herba Schizonepetae, fructus forsythiae, herba Agastaches, herba Ephedrae, gypsum Fibrosum, and Scutellariae radix as ministerial drugs. The plate Lan Gengong is especially suitable for treating initial pestilence with symptoms of fever and sore throat. Lu Gen can clear defensive qi and pathogenic heat outside and promote the production of body fluid to quench thirst inside without the disadvantage of lingering pathogenic factors. Fagopyrum tataricum root, radix Et rhizoma Fagopyri Tatarici has effects of clearing heat and detoxicating, clearing lung heat and relieving sore throat. Mint is used for clearing away heat and cooling, and has the effects of promoting resuscitation, eliminating dampness, removing dirt, relieving sore throat and inducing resuscitation. Bitter apricot kernel, semen Armeniacae amarum Xuan Li, on the upper part, can moisten the lung qi to relieve cough and asthma. Raw coix seed, semen Coicis, sweet and slightly excreted, has the effect of clearing lung-heat and clearing heat of the gold, and has the effect of removing dampness and toxin from the lower energizer. The bitter apricot kernel, the patchouli and the coix seed are combined together to eliminate three-jiao damp toxin. Cortex moutan is bitter in flavor and has effects of clearing heat, xin Santou, cooling blood, promoting blood circulation, removing blood stasis and toxic substances, and relieving epidemic toxin deep into nutrient blood. Radix Isatidis, rhizoma Phragmitis, rhizoma Fagopyri Dibotryis, herba Menthae, semen Armeniacae amarum, coicis semen and cortex moutan. Glycyrrhrizae radix is a guiding drug with slightly cold property, and has effects of clearing heat, relieving sore throat, relieving pain, and harmonizing property.

[ detailed description ] of the invention

The following provides a detailed description of specific embodiments of the invention.

Example 1A Chinese medicinal composition for treating respiratory infectious diseases

12 parts of honeysuckle, 9 parts of radix bupleuri, 9 parts of schizonepeta, 9 parts of weeping forsythia, 9 parts of patchouli, 6 parts of ephedra, 30 parts of gypsum, 9 parts of baikal skullcap root, 9 parts of bitter apricot seed, 18 parts of wild buckwheat root, 9 parts of radix isatidis, 6 parts of peppermint, 15 parts of reed rhizome, 15 parts of raw coix seed, 9 parts of moutan bark and 9 parts of raw liquorice.

Example 2A Chinese medicinal composition for treating respiratory infectious diseases (II)

12 parts of honeysuckle, 7 parts of radix bupleuri, 11 parts of schizonepeta, 5 parts of weeping forsythia, 13 parts of patchouli, 6 parts of ephedra, 25 parts of gypsum, 11 parts of baikal skullcap root, 5 parts of bitter apricot seed, 24 parts of wild buckwheat root, 9 parts of radix isatidis, 5 parts of peppermint, 17 parts of reed rhizome, 11 parts of raw coix seed, 13 parts of moutan bark and 9 parts of raw licorice.

Example 3 Chinese medicinal composition for treating respiratory infectious diseases (III)

10 parts of honeysuckle, 11 parts of radix bupleuri, 5 parts of schizonepeta, 13 parts of fructus forsythiae, 9 parts of patchouli, 5 parts of ephedra, 35 parts of gypsum, 5 parts of radix scutellariae, 13 parts of bitter apricot kernel, 18 parts of wild buckwheat root, 7 parts of radix isatidis, 7 parts of peppermint, 11 parts of reed rhizome, 19 parts of raw coix seed, 9 parts of moutan bark and 7 parts of raw liquorice.

Example 4 Chinese medicinal composition for treating respiratory infectious diseases (IV)

14 parts of honeysuckle, 5 parts of radix bupleuri, 13 parts of schizonepeta, 9 parts of weeping forsythia, 7 parts of patchouli, 7 parts of ephedra, 20 parts of gypsum, 13 parts of baikal skullcap root, 9 parts of bitter apricot seed, 15 parts of wild buckwheat root, 11 parts of radix isatidis, 4 parts of peppermint, 19 parts of reed rhizome, 15 parts of raw coix seed, 7 parts of moutan bark and 11 parts of raw liquorice.

Example 5A Chinese medicinal composition for treating respiratory infectious diseases (five)

8 parts of honeysuckle, 13 parts of radix bupleuri, 9 parts of schizonepeta, 7 parts of weeping forsythia, 11 parts of patchouli, 4 parts of ephedra, 40 parts of gypsum, 9 parts of baikal skullcap root, 7 parts of bitter apricot seed, 21 parts of wild buckwheat root, 5 parts of radix isatidis, 8 parts of peppermint, 15 parts of reed rhizome, 13 parts of raw coix seed, 11 parts of moutan bark and 5 parts of raw liquorice.

Example 6 Chinese medicinal composition for treating respiratory infectious diseases (six)

16 parts of honeysuckle, 9 parts of radix bupleuri, 7 parts of schizonepeta, 11 parts of fructus forsythiae, 5 parts of patchouli, 8 parts of ephedra, 30 parts of gypsum, 7 parts of radix scutellariae, 11 parts of bitter apricot kernel, 12 parts of wild buckwheat root, 13 parts of radix isatidis, 6 parts of peppermint, 13 parts of reed rhizome, 17 parts of raw coix seed, 5 parts of moutan bark and 13 parts of raw liquorice.

Example 7 Chinese medicinal composition for treating respiratory infectious diseases (seven)

12 parts of honeysuckle, 11 parts of radix bupleuri, 5 parts of schizonepeta, 13 parts of weeping forsythia, 9 parts of patchouli, 5 parts of ephedra, 35 parts of gypsum, 5 parts of radix scutellariae, 13 parts of bitter apricot kernel, 18 parts of wild buckwheat root, 7 parts of radix isatidis, 7 parts of peppermint, 11 parts of reed rhizome, 19 parts of raw coix seed, 9 parts of moutan bark and 7 parts of raw liquorice.

Example 8A Chinese medicinal composition for the treatment of respiratory infectious diseases (eight)

10 parts of honeysuckle, 5 parts of radix bupleuri, 13 parts of schizonepeta, 9 parts of weeping forsythia, 7 parts of patchouli, 7 parts of ephedra, 20 parts of gypsum, 13 parts of radix scutellariae, 9 parts of bitter apricot seed, 15 parts of wild buckwheat root, 11 parts of radix isatidis, 4 parts of peppermint, 19 parts of reed rhizome, 15 parts of raw coix seed, 7 parts of moutan bark and 11 parts of raw liquorice.

Example 9A Chinese medicinal composition for the treatment of respiratory infectious diseases (nine)

14 parts of honeysuckle, 13 parts of radix bupleuri, 9 parts of schizonepeta, 7 parts of weeping forsythia, 11 parts of patchouli, 4 parts of ephedra, 40 parts of gypsum, 9 parts of baikal skullcap root, 7 parts of bitter apricot seed, 21 parts of wild buckwheat root, 5 parts of radix isatidis, 8 parts of peppermint, 15 parts of reed rhizome, 13 parts of raw coix seed, 11 parts of moutan bark and 5 parts of raw liquorice.

Example 10 Chinese medicinal composition for treating respiratory infectious diseases (ten)

8 parts of honeysuckle, 9 parts of radix bupleuri, 7 parts of schizonepeta, 11 parts of fructus forsythiae, 5 parts of patchouli, 8 parts of ephedra, 30 parts of gypsum, 7 parts of radix scutellariae, 11 parts of bitter apricot kernel, 12 parts of wild buckwheat root, 13 parts of radix isatidis, 6 parts of peppermint, 13 parts of reed rhizome, 17 parts of raw coix seed, 5 parts of moutan bark and 13 parts of raw liquorice.

Example 11A Chinese medicinal composition for the treatment of respiratory infectious diseases (eleven)

16 parts of honeysuckle, 7 parts of radix bupleuri, 11 parts of schizonepeta, 5 parts of weeping forsythia, 13 parts of patchouli, 6 parts of ephedra, 25 parts of gypsum, 11 parts of baikal skullcap root, 5 parts of bitter apricot seed, 24 parts of wild buckwheat root, 9 parts of radix isatidis, 5 parts of peppermint, 17 parts of reed rhizome, 11 parts of raw coix seed, 13 parts of moutan bark and 9 parts of raw licorice.

EXAMPLE 12 preparation of Chinese medicinal composition tablet/Capsule for treating respiratory infectious diseases

Taking the traditional Chinese medicine composition in any one of embodiments 1-11, adding 9-11 times of water, decocting for 2-3.5 hours, and filtering out the decoction. Adding 9 times of water, decocting for 2.5 hr, filtering to obtain decoction, mixing the two decoctions, standing, filtering to obtain supernatant, concentrating, cooling, adding 3 times of ethanol, and stirring to precipitate overnight. Collecting supernatant, concentrating to obtain soft extract; adding pharmaceutical adjuvants, vacuum drying, pulverizing, granulating, and making into tablet or capsule.

EXAMPLE 13 preparation of Chinese medicinal composition particles for treating respiratory infectious diseases

Taking the traditional Chinese medicine composition in any one of embodiments 1-11, adding 8-10 times of water, decocting for 3 hours, and filtering out the decoction. Adding 10 times of water, decocting for 2.5 hr, filtering to obtain decoction, mixing the two decoctions, standing, filtering to obtain supernatant, concentrating, cooling, adding 2 times of ethanol, and stirring to precipitate overnight. Collecting supernatant, concentrating to obtain soft extract; adding proper pharmaceutical adjuvants, granulating, drying, grading, and packaging into 13 g/bag.

EXAMPLE 14 preparation of Chinese medicinal composition mixture/oral liquid/syrup for treating respiratory infectious diseases

Taking the traditional Chinese medicine composition in any one of embodiments 1-11, adding 8-11 times of water, decocting for 3 hours, and filtering out the decoction. Adding 8 times of water, decocting for 3 hr, filtering to obtain decoction, mixing the two decoctions, standing, filtering to obtain supernatant, concentrating, cooling, adding 3.5 times of ethanol, and stirring to precipitate overnight. Collecting supernatant, concentrating to obtain soft extract; adding proper pharmaceutical adjuvants, and making into mixture, oral liquid or syrup.

Example 15 animal experiment

1. Experimental materials

1.1 drugs and Agents

Treatment group one preparation: 12 parts of honeysuckle, 9 parts of radix bupleuri, 9 parts of schizonepeta, 9 parts of weeping forsythia, 9 parts of patchouli, 6 parts of ephedra, 30 parts of gypsum, 9 parts of baikal skullcap root, 9 parts of bitter apricot seed, 18 parts of wild buckwheat root, 9 parts of radix isatidis, 6 parts of peppermint, 15 parts of reed rhizome, 15 parts of raw coix seed, 9 parts of moutan bark and 9 parts of raw liquorice;

treatment group two preparation: 10 parts of honeysuckle, 11 parts of radix bupleuri, 5 parts of schizonepeta, 13 parts of fructus forsythiae, 9 parts of patchouli, 5 parts of ephedra, 35 parts of gypsum, 5 parts of radix scutellariae, 13 parts of bitter apricot kernel, 18 parts of wild buckwheat root, 7 parts of radix isatidis, 7 parts of peppermint, 11 parts of reed rhizome, 19 parts of raw coix seed, 9 parts of moutan bark and 7 parts of raw liquorice;

control group one preparation: 10 parts of honeysuckle, 11 parts of radix bupleuri, 5 parts of divaricate saposhnikovia root, 13 parts of dandelion, 9 parts of patchouli, 5 parts of ephedra, 35 parts of gypsum, 5 parts of baical skullcap root, 13 parts of bitter apricot seed, 18 parts of wild buckwheat root, 7 parts of Chinese violet, 7 parts of peppermint, 11 parts of reed rhizome, 19 parts of raw coix seed, 9 parts of tree peony bark and 7 parts of raw liquorice;

control group two preparation: 12 parts of honeysuckle, 9 parts of bupleurum, 9 parts of schizonepeta, 9 parts of weeping forsythia, 9 parts of patchouli, 6 parts of ephedra, 30 parts of rhizoma anemarrhenae, 9 parts of radix scutellariae, 9 parts of bitter apricot seed, 18 parts of wild buckwheat root, 9 parts of radix isatidis, 6 parts of peppermint, 15 parts of reed rhizome, 15 parts of plantain herb, 9 parts of cortex lycii radicis and 9 parts of raw liquorice;

blank group: physiological saline;

model group: physiological saline.

1.2 animals

120 BALB/c mice, male and female halves, weighing 20+ -5 g, were purchased from Shanghai Sipuler-BiKai laboratory animal Co.

1.3 major reagents and instruments

SARS-COV-2 protein (2019 novel coronavirus) (guangzhou pie biotechnology limited); mouse IL-2ELISA kit, mouse TNF-alpha ELISA kit, mouse IFN-gamma ELISA kit were all purchased from Shanghai enzyme-linked biotechnology Co., ltd; heraleus-Fresco21 microcentrifuge (Thermo Fisher technology, germany); electronic analytical balance (Mettler Co.).

2. Method and results

2.1 grouping

120 mice were grouped into model group, treatment group one, treatment group two, control group one, control group two, blank group, 20 each.

2.2 moulding and administration

In addition to the 20 mice in the blank group, the mice in the remaining groups were intranasally inoculated with SARS-CoV-2 virus at a dose of 50. Mu.L/mouse. Maintaining a light and shade cycle at 25deg.C under 8:00-20:00, feeding with laboratory standard feed, drinking water normally, and observing mouse symptoms after 24 hr, wherein the successful modeling is indicated by cough, shortness of breath, dysphoria, and shrugging. And 89 mice which are successfully molded finally are respectively: treatment group one 19, treatment group two 17, control group one 17, control group two 18, model group 18. Gastric lavage administration was started on the day of success of the evaluation model, and each group was lavaged at 20mg/kg of drug for 14 consecutive days. After the administration, blood is taken from the eyeball, the eyeball stands at 4 ℃ overnight, and serum is collected by centrifugation at 3000r/min for 10 min. The procedure was followed by the kit protocol and the concentration of IL-2, IFN-gamma, TNF-alpha in serum was calculated. Mice were sacrificed by cervical dislocation, thymus, spleen, lung were dissected out and weighed on an electronic analytical balance, organ index = organ weight (mg)/body mass (g).

2.3 statistical methods

Data were statistically processed using SPSS25.0 software. Metering data useThe t-test is used for the normal distributor.

2.4 results

2.4.1 results of thymus, spleen and Lung index detection in mice of each group

Compared with mice in the blank group, the thymus index and the spleen index of the mice in the model group are obviously reduced (p < 0.01), and the lung index is obviously increased (p < 0.05). Compared with the model group, the thymus index and the spleen index of the mice in the treatment group and the control group are obviously increased (p < 0.001) and (p < 0.05), wherein the thymus index and the spleen index of the group I are obviously higher than those of the control group I and the control group II (p < 0.05), and the lung index of the group I is obviously reduced compared with the model group (p < 0.05), and the lung index of the group I is shown in table 1.

TABLE 1 detection results of thymus index, spleen index and lung index of mice of each groupmg.g ^-1 )

Note that: * P <0.01 compared to the blank; # compared to model group, (p <0.001, p < 0.05); p <0.05 compared to control.

2.4.2 concentration of IL-2, IFN-gamma, TNF-alpha in serum from mice of each group

The 1L-2, IFN-gamma and TNF-alpha levels were all significantly elevated in the model mice compared to the placebo mice; compared with the model group, the level of 1L-2, IFN-gamma and TNF-alpha in the group of the invention and the control group is obviously reduced (p < 0.01) and (p < 0.05); the 1L-2, IFN-gamma and TNF-alpha levels were significantly reduced (p < 0.05) in the treated groups compared to the control groups, as shown in Table 2.

TABLE 2 comparison of TNF-alpha, IL-1 beta and IL-2 content in serum of mice of each group

Note that: * P <0.01 compared to the blank; # compared to model group, (p <0.01, p < 0.05); p <0.05 compared to control.

Example 16 clinical trials

1. Data and method

1.1 clinical data

The study cases are from new crown infection patients in a day 4, month 6 to month 5, day 20 of the eosin hospital, and total 456 cases; the treatment group was divided into 304 cases and 152 cases.

1.2 diagnostic criteria

Western diagnostic criteria: diagnosis of novel coronavirus asymptomatic infection is formulated with reference to diagnosis and treatment scheme (ninth edition of trial) and prevention and control scheme (eighth edition), and the novel coronavirus nucleic acid is positive in detection, and clinical typing standard is that:

light weight

The clinical symptoms are mild, and the symptoms are not manifested by pneumonia in imaging.

(II) common type

The clinical manifestations and the visible pneumonia manifestations of the imaging.

(III) heavy duty

Adults are in compliance with any of the following:

1) Shortness of breath occurs, RR is more than or equal to 30 times/minute;

2) In a resting state, the oxygen saturation degree is less than or equal to 93% when air is sucked;

3) Partial pressure of arterial blood oxygen (PaO) ₂ ) Oxygen absorption concentration (FiO) ₂ )≤300mmHg(1mmHg＝0.133kPa)；

The PaO of the high altitude (altitude is more than 1000 m) area is calculated according to the following formula ₂ /FiO ₂ Correction of PaO ₂ /FiO ₂ X [ 760/atmospheric pressure (mmHg)]。

4) Clinical symptoms are progressively aggravated, and pulmonary imaging shows that lesions significantly progress >50% within 24-48 hours.

Children were in compliance with any one of the following:

1) Sustaining hyperthermia for more than 3 days;

2) Shortness of breath (less than 2 months of age, RR is more than or equal to 60 times/min; 2-12 months old, RR is more than or equal to 50 times/minute; 1-5 years old, RR is more than or equal to 40 times/min; >5 years old, RR > 30 times/min), except for effects of fever and crying;

3) In a resting state, the oxygen saturation degree is less than or equal to 93% when air is sucked;

4) Assisted respiration (nasal fan, tricravure);

5) Somnolence and convulsion occur;

6) Refusal to eat or difficult to feed, and has dehydration sign.

(IV) Critical type

One of the following conditions is met:

1) Respiratory failure occurs and mechanical ventilation is required;

2) Shock occurs;

3) ICU monitoring therapy is required to incorporate other organ failure.

1.3 inclusion criteria

The user can choose to meet all of the following criteria:

(1) Age 18-65 years (18 and 65 years inclusive), with unlimited sex;

(2) The method has the advantages that the novel crown infection close-fitting and sub-close-fitting standard is adopted, the nucleic acid detection result is positive, and the clinical typing is light and common;

(3) Voluntary attends the trial and signs written informed consent.

1.4 exclusion criteria

Any one of the following criteria is satisfied, namely, to be excluded:

(1) Nasal diseases (such as allergic rhinitis, acute and chronic sinusitis, etc.) in other acute attack phases, such as influenza, other pneumonia, suppurative tonsillitis, acute tracheobronchitis, pulmonary tuberculosis, primary ciliated dyskinesia syndrome, and other symptoms;

(2) Other medicines for the disease such as cold medicine, antiviral medicine, antibiotics, traditional Chinese medicine and the like are accepted for treatment before the doctor seeing the doctor in the course of the disease;

(3) Gastrointestinal discomfort symptoms such as acute and chronic diarrhea;

(4) Serious primary diseases such as viral hepatitis, hemophilia, diabetes mellitus with unstable control/serious complications, mental diseases, and the like, which are combined with serious heart, brain, lung, liver, kidney, blood systems, and the like;

(5) Women who are pregnant or are scheduled to be pregnant, women in lactation, patients in gestational age who are unable or unwilling to take adequate contraception during the test or their spouse are unwilling to take contraceptive measures;

(6) Allergic constitution, such as history of allergy to more than two drugs or foods, or known allergy to each component of the study drug;

(7) Take part in or are taking part in other clinical trials of the drug within 3 months;

(8) At the discretion of the researcher, there are other lesions or conditions that reduce the likelihood of or complicate the inclusion of groups, such as pregnancy, frequent changes in working environment, unstable living environment, etc., which are susceptible to missed visits.

1.5 methods of treatment

Control group: one tenth of the dose of Jing Yinqing formulation intervenes;

treatment group: jing Yinqing prescription intervention.

1.6 statistical treatment

The data from this study were statistically analyzed using SPSS25.0 software. The counting data are described by frequency and composition ratio, and comparison is performed by X2 test. If the metering data accords with normal distribution, comparing the metering data by adopting two independent sample t-tests, and comparing the metering data by adopting paired t-tests; if the normal distribution is not met, rank sum test is adopted. The difference of P <0.05 is statistically significant

1.7 observations index

(1) The main curative effect index is as follows:

novel coronavirus nucleic acid detects Ct value changes of N gene and ORF gene.

Nucleic acid detection was performed on days 0, 3, and 6, respectively.

The Ct values of the N gene and the ORF gene of the novel coronavirus nucleic acid detection are determined by adopting a fluorescence quantitative PCR method, and the method is negative: no Ct value or Ct value >40. Positive: ct value <35. The Ct value (cycle threshold) refers to the Ct value of nucleic acid detection, i.e., the number of cycles required for pcr fluorescence signal to reach a threshold.

And qualitatively judging whether the nucleic acid turns negative or not according to the Ct value and counting the negative turning rate.

(2) Secondary efficacy index:

(1) conversion to normal type rate: counting the number of people who change into a new crown infection common type during the test period by researchers;

(2) mean nucleic acid to negative time: nucleic acid detection was performed on days 0, 3, and 6, respectively.

1.8 method for evaluating clinical efficacy

The nucleic acid negative conversion rate is expressed as a percentage, and the nucleic acid negative conversion rate=accounting negative conversion number/total number of the same group is 100%.

2. Results

2.1 comparison of nucleic acid to negative conversion ratio of 3d and 6d of each group of drugs

On day 3 after Jing Yinqing formulation administration, the nucleic acid negative conversion rate showed: jing Yinqing formulation 35.5%, placebo control (one tenth of the dose of Jing Yinqing formulation) 19.1%, and there was a statistical difference in the conversion to negative between the test and placebo control (p < 0.001). On day 6 after administration, the nucleic acid negative conversion rate showed: jing Yinqing formulation was 83.2% and placebo control (one tenth of the dose of Jing Yinqing formulation) was 61.2% with statistical differences in the conversion to negative (p < 0.001) between the test and placebo control. See tables 3 and 4.

Table 3 comparative nucleic acid to negative conversion ratio in two sets of 3d [ example (%)

Table 4 comparative nucleic acid conversion to negative in two groups of 6d [ example (%)

3. Conclusion(s)

After 1 course of treatment (6 days), the mean time to negative for the patients in the test group was 4.21 days, 5.13 days (p < 0.05) lower than the placebo control group, and none of the inclusion observations turned to heavy. Jing Yinqing the method for treating novel coronavirus light/common patients can shorten nucleic acid negative transfer time and accelerate discharge time.

The foregoing is merely a preferred embodiment of the present invention, and it should be noted that modifications and additions may be made to those skilled in the art without departing from the method of the present invention, which modifications and additions are also to be considered as within the scope of the present invention.

Claims

1. The Jingyin clearing prescription is characterized by being prepared from the following raw materials in parts by weight: 8-16 parts of honeysuckle, 5-13 parts of radix bupleuri, 5-13 parts of schizonepeta, 5-13 parts of fructus forsythiae, 5-13 parts of patchouli, 4-8 parts of ephedra, 20-40 parts of gypsum, 5-13 parts of radix scutellariae, 5-13 parts of bitter apricot kernel, 12-24 parts of wild buckwheat root, 5-13 parts of radix isatidis, 4-8 parts of mint, 11-19 parts of reed rhizome, 11-19 parts of raw coix seed, 5-13 parts of tree peony bark and 5-13 parts of raw liquorice.

2. The traditional Chinese medicine composition according to claim 1, which is characterized by being prepared from the following raw materials in parts by weight: 10-14 parts of honeysuckle, 7-11 parts of radix bupleuri, 7-11 parts of schizonepeta, 7-11 parts of fructus forsythiae, 7-11 parts of patchouli, 5-7 parts of herba ephedrae, 25-35 parts of gypsum, 7-11 parts of radix scutellariae, 7-11 parts of bitter apricot seed, 15-21 parts of wild buckwheat root, 7-11 parts of radix isatidis, 5-7 parts of mint, 13-17 parts of reed rhizome, 13-17 parts of raw coix seed, 7-11 parts of tree peony bark and 7-11 parts of raw liquorice.

3. The traditional Chinese medicine composition according to claim 2, which is characterized by being prepared from the following raw materials in parts by weight: 12 parts of honeysuckle, 9 parts of radix bupleuri, 9 parts of schizonepeta, 9 parts of weeping forsythia, 9 parts of patchouli, 6 parts of ephedra, 30 parts of gypsum, 9 parts of baikal skullcap root, 9 parts of bitter apricot seed, 18 parts of wild buckwheat root, 9 parts of radix isatidis, 6 parts of peppermint, 15 parts of reed rhizome, 15 parts of raw coix seed, 9 parts of moutan bark and 9 parts of raw liquorice.

4. The Chinese medicinal composition according to any one of claims 1 to 3, wherein the pharmaceutical agent of the Chinese medicinal composition is a granule, a decoction, a tablet, a capsule, an oral liquid, a mixture or a syrup.

5. Use of a Chinese medicinal composition according to any one of claims 1-3 for the preparation of a medicament for the treatment of respiratory infectious diseases.