Application of children Danqing Shuangliang granules in preparation of medicine for treating acute inflammation

Abstract

The invention provides an application of children Danqing Shuanglian granules in preparation of drugs for treating acute inflammation. The acute inflammation comprises acute upper respiratory tract infection, bronchitis, amygdalitis and pneumonia caused by virus infection (H1N1, H3N2, FluB and HRSV) or abnormal immunoreaction. Raw materials of the granules comprise nauclea officinalis, artemisia apiacea, scutellaria baicalensis and other traditional Chinese medicinal materials and anti-inflammatory regulatory peptide. The preparation process comprises the following steps: extracting volatile oil by steam distillation, extracting effective components by combining microwave assistance and ultrasonic enhancement, carrying out beta-cyclodextrin inclusion on polypeptide to enhance the stability, and finally granulating to obtain granules with the water content of less than or equal to 6%. Experiments show that the inhibition rate of the drug to HRSV under the maximum non-toxic concentration reaches 81.8% + / -2.0%, and the therapeutic index is SIgt; 2, the latency period of ammonia water induced mouse cough can be remarkably prolonged, the cough frequency is reduced, the antiviral, anti-inflammatory and antitussive effects are achieved, and a safe and effective traditional Chinese medicine choice is provided for clinical treatment of viral acute inflammation.

Description

Technical Field

[0001] The present invention relates to the technical field of medicine preparation, and in particular to application of Xiaoer Danqing Shuangjie granules in preparing medicine for treating acute inflammation. Background Art

[0002] Acute inflammation is a common clinical disease in pediatrics, with viral infection (such as H1N1, H3N2, FluB, HRSV, etc.) or abnormal immune response as the main cause. Clinical manifestations include acute upper respiratory tract infection, bronchitis, tonsillitis and pneumonia, etc., with the characteristics of rapid onset, rapid spread and many complications. Currently, clinical treatment is mainly based on chemical drugs, such as the antiviral drugs oseltamivir and zanamivir. Although they are effective against some viruses, they have obvious limitations: on the one hand, viruses can easily develop drug resistance through gene mutations, resulting in reduced drug efficacy; on the other hand, chemical drugs generally have side effects such as gastrointestinal reactions and liver and kidney burden, especially for children with imperfect liver and kidney function. The risk is higher. In addition, for inflammation caused by abnormal immune response, it is difficult to take into account the anti-inflammatory needs with antiviral treatment alone, and glucocorticoids need to be used in combination, which further increases the risk of adverse reactions.

[0003] At present, the commonly used Western medicines for respiratory viral infections in clinical practice include valacyclovir, interferon, amantadine, oseltamivir, and oseltamivir. However, due to the high mutation rate of respiratory viral antigens, they are prone to drug resistance and adverse reactions, which seriously affect their efficacy and limit their clinical application.

[0004] Traditional Chinese medicine (TCM) offers unique advantages in treating viral infections, with its multi-component, multi-target approach. However, existing technologies present significant deficiencies. Traditional TCM formulas often rely on empirical combinations and lack a clear understanding of the underlying substance and mechanism of action. For example, the classic formula Lianqiaosan, while widely used for treating wind-heat colds, remains unclear regarding its inhibitory rate against specific viruses like HRSV and its immunomodulatory mechanisms. Preparation processes are crude, with most using simple decoctions, resulting in low yields of active ingredients. Quality control systems are imperfect, lacking quantifiable activity evaluation indicators, making modern pharmacological validation difficult. Furthermore, existing antiviral TCMs often suffer from high onset concentrations and low therapeutic indices, making it difficult to balance efficacy and safety. Summary of the Invention

[0005] In view of this, the present invention proposes the use of Xiaoer Danqing Shuangjie Granules in the preparation of medicines for treating acute inflammation.

[0006] The technical solution of the present invention is achieved as follows: the use of Xiaoer Danqing Shuangjie Granules in the preparation of a drug for treating acute inflammation, wherein the acute inflammation includes at least one of acute upper respiratory tract infection, acute bronchitis, acute tonsillitis or acute pneumonia, and the acute upper respiratory tract infection is caused by virus strains of influenza A virus H1N1, H3N2, influenza B virus FluB, and respiratory syncytial virus HRSV.

[0007] Furthermore, the raw materials of the pediatric Danqing Shuangjie granules include the following components in parts by weight: 25-50 parts of Gallwood, 25-50 parts of Artemisia annua, 15-25 parts of Scutellaria baicalensis, 15-25 parts of Anemarrhena asphodeloides, 10-20 parts of Forsythia suspensa, 5-15 parts of Honeysuckle, 5-15 parts of Phragmites australis, 5-15 parts of Platycodon grandiflorum, 3-10 parts of Licorice, and 3-8 parts of Gypsum.

[0008] Furthermore, the raw materials of the pediatric Danqing Shuangjie granules also include the following components in parts by weight: 15-28 parts of Arisaema consanguineum, 10-25 parts of Indigo naturalis, 3-8 parts of Viola yedoensis, 5-10 parts of Herba Epimedii, 3-8 parts of Rubescens rubescens, and 6-10 parts of anti-inflammatory regulatory peptides, wherein the anti-inflammatory regulatory peptides are bitter melon seed polypeptide and Echinacea purpurea polypeptide in a mass ratio of 1:3-8, and the molecular weight distribution is concentrated in 500-3000Da.

[0009] Furthermore, the preparation method of the Xiaoer Danqing Shuangjie Granules comprises the following steps:

[0010] S1. Volatile oil extraction: Grind Artemisia annua, honeysuckle, and forsythia suspensa into 40-60 mesh, add 6-8 times the volume of purified water, soak for 30-60 minutes, and extract the volatile oil by steam distillation for 4-6 hours. Collect the volatile oil for later use, drain the residue I, and combine it with the remaining Chinese medicinal materials;

[0011] S2. Pretreatment of mineral medicine: Grind gypsum into 80-100 mesh, add 4-6 times the volume of purified water, boil and keep it at a slight boil for 1-1.5 hours to obtain gypsum decoction for later use;

[0012] S3, raw material pretreatment: scutellaria baicalensis, anemarrhena, phragmites australis, platycodon grandiflorum, liquorice, violet yedoensis, herba euphorbiae, rubescens and residue I of S1 were mixed, broken and passed through a 70-90 mesh sieve to obtain powder I; arisaema cinerea and indigo naturalis were separately ground to 90-120 mesh, and degreased by CO2 supercritical fluid to a fat content of <1% to obtain powder II;

[0013] S4. Segment extraction:

[0014] The first stage: add 6-9 times the volume of purified water to the pretreated powder I, perform microwave-assisted extraction for 20-40 minutes, maintain reflux at 70-90°C for 1-2 hours, and filter to obtain extract I and residue II;

[0015] The second stage: add 5-7 times the weight of 60-70% v / v ethanol solution to the residue II, perform ultrasonic enhanced extraction, reflux at 50-70°C for 1-1.5 hours, and filter to obtain extract II and residue III;

[0016] The third stage: Add the drug residue III to the drug powder II and 8-12 times the volume of purified water, high-pressure steam explosion, and decoct for 30-50 minutes to obtain the extract III;

[0017] S5. Peptide treatment: The anti-inflammatory regulatory peptide is dissolved in 5-8 volumes of purified water at 37-45°C, and 0.1-0.3% (w / v) β-cyclodextrin is added and stirred for inclusion for 20-40 minutes to form a peptide inclusion complex;

[0018] S6. Combine the extracts I, II, and III with the gypsum decoction from step S2, and concentrate under reduced pressure to a clear paste with a relative density of 1.20-1.25. Add the polypeptide inclusion complex from step S5, the volatile oil from step S1, and the auxiliary materials in sequence, and stir until no granular lumps are formed to obtain a soft material. Pass the soft material through a 14-16 mesh sieve to granulate the granules, dry them at 50-60°C for 2-3 hours to reduce the moisture content to ≤6%, sterilize and package them to obtain the Xiaoer Danqing Shuangjie Granules.

[0019] Furthermore, in step S3, the CO2 supercritical degreasing pressure is 25-30 MPa, the temperature is 40-60°C, and the time is 40-60 min.

[0020] Furthermore, the microwave-assisted extraction in step S4 has a power of 700-900 W and a frequency of 2400-2600 MHz.

[0021] Furthermore, the ultrasonic enhanced extraction in step S4 has a frequency of 30-50 kHz and a power of 200-400 W.

[0022] Furthermore, in step S4, the high-pressure steam explosion pressure is 0.5-0.9 MPa and maintained for 4-6 minutes.

[0023] Furthermore, the auxiliary materials in step S6 are 10-20 parts of dextrin and 30-50 parts of mannitol.

[0024] Compared with the prior art, the present invention has the following beneficial effects:

[0025] The Xiaoer Danqing Shuangjie Granules of the present invention use Gallwood and Artemisia annua as the main ingredients, clearing heat and resisting viruses, targeting the main symptoms of lung heat and viral infections; Scutellaria baicalensis, Anemarrhena asphodeloides, Honeysuckle, and Silver Ostrife as the auxiliary ingredients, assisting in clearing heat and clearing the exterior and interior; adjuvants include Arisaema consanguineum and Indigo naturalis for expectoration, Platycodon grandiflorum and Phragmites australis for sore throat, and Viola yedoensis for enhancing heat-clearing and detoxification; anti-inflammatory peptides regulate immunity, while Gypsum restrains the medicinal properties and prevents damage to Yang; and Licorice serves as the adjuvant to harmonize the other ingredients and guide them into the lungs. The entire formula clears and detoxifies, resolves phlegm and relieves sore throat. Modern processes such as polypeptide inclusion and supercritical degreasing enhance efficacy and safety, achieving a synergistic effect of antiviral, anti-inflammatory, and antitussive effects. It is used for viral acute upper respiratory tract infections, bronchitis, and pneumonia (caused by pathogens such as H1N1 / H3N2 / FluB / HRSV), with symptoms such as fever, cough, sore throat, and yellow sputum, and has multiple therapeutic effects including antipyretic, anti-inflammatory, and immunomodulatory. DETAILED DESCRIPTION

[0026] In order to better understand the technical content of the present invention, specific examples are provided below to further illustrate the present invention.

[0027] Unless otherwise specified, the experimental methods used in the examples of the present invention are all conventional methods.

[0028] Unless otherwise specified, the materials, reagents, etc. used in the examples of the present invention can be obtained from commercial sources.

[0029] The bitter melon seed polypeptide of the present invention is prepared by grinding bitter melon seeds into 50 μm, defatting with petroleum ether (1:5 = bitter melon seeds: petroleum ether, 30°C, 3 times) and vacuum drying (50°C, -0.07 MPa) to obtain defatted powder; the defatted powder is mixed with water at a ratio of 1:10, neutral protease (1:100) is added, and enzymatic hydrolysis is carried out at 50°C for 3 hours, the enzyme is inactivated, and the supernatant is collected by centrifugation. The supernatant is fractionated through 3 kDa and 1 kDa ultrafiltration membranes, concentrated to 5-8 mg / mL to obtain a crude extract, and freeze-dried to obtain a powder, thereby obtaining the bitter melon seed polypeptide.

[0030] The Echinacea polypeptide of the present invention is prepared by drying and crushing the aerial part of Echinacea, ultrasonically extracting it with 80% w / w ethanol (400W, 40kHz, 50°C), concentrating it under reduced pressure to obtain an aqueous extract, successively adding alkaline protease and flavor protease (1:200 and 1:300), performing enzymatic hydrolysis at 60°C for 3 hours, centrifuging the extract, and gradient eluting it with a DEAE-52 column. The extract is treated with a 2kDa cutoff ultrafiltration membrane to obtain a purified solution, which is then concentrated and added with 0.5% purified beta-cyclodextrin. The extract is then spray-dried to obtain a powder (purity ≥85%, molecular weight 500-2000Da).

[0031] The following introduces the basic information of the main raw materials based on the "Chinese Pharmacopoeia", "Chinese Materia Medica Dictionary" and "Chinese Herbal Medicine".

[0032] 1. Gallwood (Quersaceae)

[0033] Nature and flavor: bitter, cold

[0034] Meridians: Liver, Gallbladder, Lung

[0035] Functions and indications: Clears away heat and detoxifies, reduces swelling and relieves pain.

[0036] 2. Artemisia annua (Compositae)

[0037] Nature and flavor: bitter, pungent, cold

[0038] Meridians: Liver, Gallbladder, Kidney

[0039] Functions and indications: Clears away heat from internal organs, eliminates bone steaming, relieves summer heat, stops malaria, and reduces jaundice.

[0040] 3. Scutellaria baicalensis (Lamiaceae)

[0041] Nature and flavor: bitter, cold

[0042] Meridians: Lung, Gallbladder, Spleen, Large Intestine, Small Intestine

[0043] Functions and indications: Clears heat and dampness, purges fire and detoxifies, and stops bleeding.

[0044] 4. Anemarrhena asphodeloides (Liliaceae)

[0045] Nature and flavor: bitter, sweet, cold

[0046] Meridians: Lung, stomach, and kidney meridians

[0047] Functions and indications: Clears heat and purges fire, nourishes yin and moistens dryness.

[0048] 5. Forsythia suspensa (Oleaceae)

[0049] Nature and flavor: bitter, slightly cold

[0050] Meridians: Lung, Heart, Small Intestine

[0051] Functions and indications: Clears away heat and detoxifies, reduces swelling and resolves stagnation, and dispels wind-heat.

[0052] 6. Honeysuckle (Caprifoliaceae)

[0053] Nature and flavor: sweet, cold

[0054] Meridians: Lung, Heart, and Stomach

[0055] Functions and indications: Clears away heat and detoxifies, dispels wind-heat.

[0056] 7. Phragmites australis (Gramineae)

[0057] Nature and flavor: sweet, cold

[0058] Meridians: Lung and Stomach

[0059] Functions and indications: Clears away heat and purges fire, promotes the production of body fluids and quenches thirst, relieves restlessness, stops vomiting, and promotes urination.

[0060] 8. Platycodon grandiflorum (Campanulaceae)

[0061] Nature and flavor: bitter, spicy, flat

[0062] Meridian: Lung meridian

[0063] Functions and indications: Clears lungs, relieves sore throat, eliminates phlegm and discharges pus.

[0064] 9. Licorice (Leguminosa)

[0065] Nature and flavor: sweet, flat

[0066] Meridians: Heart, Lung, Spleen, Stomach

[0067] Functions and indications: Tonifies 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 deficiency, fatigue, palpitations and shortness of breath, cough with sputum, carbuncles, sores, and cramps and pain in the limbs; it also relieves drug toxicity and potency.

[0068] 10. Gypsum (mineral medicinal material)

[0069] Nature and flavor: sweet, spicy, very cold

[0070] Meridians: Lung and Stomach

[0071] Functions and indications: Clears away heat and purges fire, relieves restlessness and quenches thirst.

[0072] 11. Arisaema (Arisaema processed with bile)

[0073] Nature and flavor: bitter, pungent, cool (or cold)

[0074] Meridians: Lung, Liver, Spleen

[0075] Functions and indications: Clears away heat and resolves phlegm, calms wind and soothes convulsions.

[0076] 12. Indigo (processed products from plants such as Acanthaceae)

[0077] Nature and flavor: salty, cold

[0078] Meridians: Liver and Lung

[0079] Functions and indications: Clears away heat and detoxifies, cools blood and eliminates spots, purges fire and calms the nerves.

[0080] 13. Viola yedoensis (Violaceae)

[0081] Nature and flavor: bitter, pungent, cold

[0082] Meridians: Heart and Liver

[0083] Functions and indications: Clears away heat and detoxifies, cools blood and reduces swelling.

[0084] 14. Euphorbiaceae

[0085] Nature and flavor: pungent, bitter, neutral

[0086] Meridians: Liver and Large Intestine

[0087] Functions and indications: Clears away heat and detoxifies, cools blood and stops bleeding, promotes dampness and reduces jaundice.

[0088] 15. Rabdosia rubescens (Lamiaceae)

[0089] Nature and flavor: bitter, sweet, slightly cold

[0090] Meridians: Lung, stomach, liver

[0091] Functions and indications: Clears away heat and detoxifies, promotes blood circulation and relieves pain, relieves sore throat and reduces swelling.

[0092] Example 1

[0093] Raw material composition (by weight): 35 parts of Gallwood, 35 parts of Artemisia annua, 20 parts of Scutellaria baicalensis, 20 parts of Anemarrhena asphodeloides, 15 parts of Forsythia suspensa, 10 parts of Honeysuckle, 10 parts of Phragmites australis, 10 parts of Platycodon grandiflorum, 6 parts of Licorice, 6 parts of Gypsum, 20 parts of Arisaema cinerea, 18 parts of Indigo naturalis, 5 parts of Viola yedoensis, 7 parts of Euphorbia milii, 5 parts of Rabdosia rubescens, 8 parts of anti-inflammatory regulatory peptide (Momordica charantia seed polypeptide: Echinacea purpurea polypeptide = 1:5, molecular weight 800-2000Da), excipients: 15 parts of dextrin, 40 parts of mannitol.

[0094] Preparation steps:

[0095] S1 Volatile Oil Extraction: Grind Artemisia annua, honeysuckle, and forsythia suspensa to 50 mesh, add 7 times the volume of purified water and soak for 45 minutes, steam distill for 5 hours, collect the volatile oil, and combine the obtained residue I with the remaining medicinal materials such as Gallwood;

[0096] S2 Mineral drug pretreatment: Gypsum was crushed into 90 mesh, added with 5 times the amount of water and boiled for 1.2 hours to obtain gypsum decoction;

[0097] S3 raw material pretreatment: powder I was crushed and passed through an 80-mesh sieve, and powder II was supercritically defatted (pressure 28 MPa, temperature 50°C, time 50 min) to a fat content of 0.8%;

[0098] S4 segment extraction:

[0099] The first stage: Add 8 times the amount of purified water to the powder I, perform microwave-assisted extraction (power 800W, frequency 2450MHz) for 30min, reflux at 80℃ for 1.5h, and filter to obtain extract I and residue II;

[0100] The second stage: Add 6 times the mass of 65% v / v ethanol to the residue II, perform ultrasonic extraction (frequency 40 kHz, power 300 W), reflux at 60°C for 1.2 h, and filter to obtain extract II and residue III;

[0101] The third stage: Add the medicinal residue III to the medicinal powder II and 10 times the amount of water, high-pressure steam explosion (0.7MPa, 5min) and then boil for 40min to obtain the extract III;

[0102] S5 peptide treatment: The anti-inflammatory regulatory peptide was dissolved in 6 times the volume of purified water at 40°C and included in 0.2% (w / v) β-cyclodextrin for 30 min;

[0103] S6 granulation: Combine extracts I, II, and III with the gypsum decoction, concentrate under reduced pressure to a relative density of 1.22 (60°C), add the polypeptide inclusion complex, volatile oil, and excipients in sequence, granulate with a 14-mesh sieve, and dry at 55°C for 2.5 hours, with a moisture content of 5.2%.

[0104] Example 2

[0105] Raw material composition (by weight): 50 parts of Gallwood, 50 parts of Artemisia annua, 25 parts of Scutellaria baicalensis, 25 parts of Anemarrhena asphodeloides, 20 parts of Forsythia suspensa, 15 parts of Honeysuckle, 15 parts of Phragmites australis, 15 parts of Platycodon grandiflorum, 10 parts of Licorice, 8 parts of Gypsum, 28 parts of Arisaema consanguineum, 25 parts of Indigo naturalis, 8 parts of Viola yedoensis, 10 parts of Herba Euphorbiae Ichthyophthirius, 8 parts of Rabdosia rubescens, 10 parts of anti-inflammatory regulatory peptide (Momordica charantia seed polypeptide: Echinacea purpurea polypeptide = 1:3, molecular weight 500-3000Da) Excipients: 20 parts of dextrin, 50 parts of mannitol.

[0106] The preparation method is the same as that of Example 1.

[0107] Example 3

[0108] Raw material composition (by weight): 25 parts of Gallwood, 25 parts of Artemisia annua, 15 parts of Scutellaria baicalensis, 15 parts of Anemarrhena asphodeloides, 10 parts of Forsythia suspensa, 5 parts of Honeysuckle, 5 parts of Phragmites australis, 5 parts of Platycodon grandiflorum, 3 parts of Licorice, 3 parts of Gypsum, 15 parts of Arisaema consanguineum, 10 parts of Indigo naturalis, 3 parts of Viola yedoensis, 5 parts of Herba Euphorbiae Ichthyophthirius, 3 parts of Rabdosia rubescens, 6 parts of anti-inflammatory regulatory peptide (Momordica charantia seed polypeptide: Echinacea purpurea polypeptide = 1:8, molecular weight 1000-2500Da) Excipients: 10 parts of dextrin, 30 parts of mannitol.

[0109] The preparation method is the same as that of Example 1.

[0110] Test Example 1-In vitro anti-inflammatory test

[0111] 1. Test materials

[0112] Test sample: Xiaoer Danqing Shuangjie Granules (Example 1, 4.08g crude drug / g extract powder)

[0113] Reference substance: Ibuprofen (200 mg / kg for mice, 130 mg / kg for rats)

[0114] Experimental animals: KM mice (male, 18-21 days old), SD rats (male, 21 days old), supplier: Sibeifu (Beijing) Biotechnology Co., Ltd.

[0115] 2. Test methods

[0116]

[0117] 3. Result test

[0118]

[0119]

[0120] Note: Compared with the model control group, # P≤0.05, ## P≤0.01; **P≤0.01 compared with the normal control group

[0121] Xiaoer Danqing Shuangjie Granules significantly inhibited ear swelling in mice at a dose of 8 g crude drug / kg (P ≤ 0.01).

[0122] In a rat paw edema model induced by carrageenan, doses of 5-20 g of the crude drug / kg significantly reduced paw swelling (P ≤ 0.05-P ≤ 0.01). Pediatric Danqing Shuangjie Granules at doses of 5, 10, and 20 g of the crude drug / kg also significantly reduced paw swelling. The onset of effect was concentrated within 2 hours after model establishment. In summary, the anti-inflammatory effect is comparable to that of ibuprofen, and Pediatric Danqing Shuangjie Granules have a significant inhibitory effect on acute inflammation.

[0123] Test Example 2-In vitro antiviral test

[0124] 1. Test materials

[0125] Test sample: Xiaoer Danqing Shuangjie Granules (Example 1, 4.08g crude drug / g extract powder)

[0126] Positive control: Oseltamivir

[0127] Host cells: MDCK cells (for influenza virus), HEp-2 cells (for HRSV)

[0128] Test viruses: H1N1, H3N2, FluB, HRSV

[0129] 2. Test methods

[0130] The maximum non-toxic concentration (TC0) was determined by CCK-8 assay to determine the maximum concentration (TC0) of the test article that had no significant toxicity to MDCK and HEp-2 cells.

[0131] The median lethal dose (TCID) of the virus 50 ) Determination: The Reed-Muench method was used to calculate the half-lethal concentration of the virus to cells.

[0132] Antiviral activity assay:

[0133] (1) After the virus infects the cells, add the test sample to the serially diluted solution;

[0134] (2) Cell viability was determined by CCK-8 method, and the virus inhibition rate and half-maximal inhibitory concentration (IC) at the maximum non-toxic concentration were calculated. 50 ) and therapeutic index (SI = TC0 / IC 50 );

[0135] Judgment criteria: SI>2 indicates low toxicity and high efficiency; SI: 1-2 indicates high toxicity and low efficiency; SI<1 indicates ineffectiveness.

[0136] 3. Test results

[0137] Maximum non-toxic concentration:

[0138] MDCK cells: TC0 = 62.5 μg crude drug / mL

[0139] HEp-2 cells: TC0 = 1000 μg crude drug / mL

[0140]

[0141] Xiaoer Danqing Shuangjie Granules showed significant in vitro antiviral activity against H1N1, H3N2, FluB and HRSV (SI all > 2), especially against H1N1 and HRSV, with therapeutic indexes of 29.8 and 39.4, respectively, confirming its low toxicity and high efficiency, making it an important candidate for the development of anti-respiratory virus drugs.

[0142] Test Example 3 - Antitussive Effect Test

[0143] 1. Test materials

[0144] Test sample: Xiaoer Danqing Shuangjie Granules (4.08g crude drug / g extract powder)

[0145] Positive control: Pentoxetine (24 mg / kg)

[0146] Experimental animals: ICR mice (male, 17 days old, SPF grade)

[0147] 2. Test methods

[0148] Model construction: Ammonia (20%) was used to induce a cough model in mice, and the cough latency and the number of coughs within 5 minutes were recorded.

[0149] Grouping and dosing:

[0150] Administration: Oral administration, the administration volume is 20mL / kg, once a day for 3 consecutive days.

[0151]

[0152] 3. Test results:

[0153]

[0154] Note: 1. n is the number of animals; 2. Compared with the model control group, # P≤0.05, ## P≤0.01.

[0155] At a dose of 8-32 g crude drug / kg, Xiaoer Danqing Shuangjie Granules significantly prolonged the latent period of cough and reduced the number of coughs, with an effect intensity comparable to that of pentoxyverine (P>0.05).

[0156] The results showed that the drug has clear antitussive activity against cough symptoms associated with acute inflammation (acute bronchitis, upper respiratory tract infection), and can serve as an important basis for the efficacy of drugs for the treatment of acute inflammation.

[0157] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention should be included in the scope of protection of the present invention.

Claims

1. The use of Xiaoer Danqing Shuangjie Granules in the preparation of a drug for treating acute inflammation, characterized in that: The acute inflammation includes an inflammatory response caused by viral infection or abnormal immune response, and the viral infection is caused by viral strains H1N1, H3N2, FluB, and HRSV.

2. The use according to claim 1, characterized in that The clinical manifestation of the inflammatory response is at least one of acute upper respiratory tract infection, acute bronchitis, acute tonsillitis or acute pneumonia.

3. The use according to claim 2, characterized in that The raw materials of the pediatric Danqing Shuangjie granules include the following components in parts by weight: 25-50 parts of Gallwood, 25-50 parts of Artemisia annua, 15-25 parts of Scutellaria baicalensis, 15-25 parts of Anemarrhena asphodeloides, 10-20 parts of Forsythia suspensa, 5-15 parts of Honeysuckle, 5-15 parts of Phragmites australis, 5-15 parts of Platycodon grandiflorum, 3-10 parts of Licorice, and 3-8 parts of Gypsum.

4. The use according to claim 3, characterized in that The raw materials of the pediatric Danqing Shuangjie granules also include the following components in parts by weight: 15-28 parts of Arisaema consanguineum, 10-25 parts of Indigo naturalis, 3-8 parts of Viola yedoensis, 5-10 parts of Herba Euphorbiae Ichthyophthirius, 3-8 parts of Rubescens rubescens, and 6-10 parts of anti-inflammatory regulatory peptides. The anti-inflammatory regulatory peptides are bitter melon seed polypeptide and Echinacea purpurea polypeptide in a mass ratio of 1:3-8, and the molecular weight distribution is concentrated in 500-3000Da.

5. The use according to claim 4, characterized in that The preparation method of the Xiaoer Danqing Shuangjie granules comprises the following steps: S1. Volatile oil extraction: crush Artemisia annua, honeysuckle, and forsythia suspensa, add 6-8 times the volume of purified water, soak for 30-60 minutes, and extract the volatile oil by steam distillation for 4-6 hours. Collect the volatile oil for later use, drain the residue I, and combine it with the remaining Chinese medicinal materials; S2. Pretreatment of mineral medicine: Grind gypsum, add 4-6 times the volume of purified water, boil and keep it at a slight boil for 1-1.5 hours to obtain gypsum decoction for later use; S3, raw material pretreatment: scutellaria baicalensis, anemarrhena, phragmites australis, platycodon grandiflorum, liquorice, violet yedoensis, herba euphorbiae, rubescens and residue I of S1 were mixed, broken and passed through a 70-90 mesh sieve to obtain powder I; arisaema cinerea and indigo naturalis were separately ground to 90-120 mesh, and degreased by CO2 supercritical fluid to a fat content of <1% to obtain powder II; S4. Segment extraction: The first stage: add 6-9 times the volume of purified water to the pretreated powder I, perform microwave-assisted extraction for 20-40 minutes, maintain reflux at 70-90°C for 1-2 hours, and filter to obtain extract I and residue II; The second stage: add 5-7 times the weight of 60-70% v / v ethanol solution to the residue II, perform ultrasonic enhanced extraction, reflux at 50-70°C for 1-1.5 hours, and filter to obtain extract II and residue III; The third stage: Add the drug residue III to the drug powder II and 8-12 times the volume of purified water, high-pressure steam explosion, and decoct for 30-50 minutes to obtain the extract III; S5. Peptide treatment: The anti-inflammatory regulatory peptide is dissolved in 5-8 volumes of purified water at 37-45°C, and 0.1-0.3% (w / v) β-cyclodextrin is added and stirred for inclusion to form a peptide inclusion complex; S6. Granulation: Combine the extracts I, II, and III with the gypsum decoction from step S2, concentrate under reduced pressure to obtain a clear paste, add the polypeptide inclusion complex from step S5, the volatile oil from step S1, and the auxiliary materials in sequence, and stir until there are no granular lumps to obtain a soft material; sieve the soft material to granulate, dry it to make the moisture content ≤6%, sterilize and package it to obtain the Children's Danqing Shuangjie Granules.

6. The use according to claim 5, characterized in that The CO2 supercritical degreasing in step S3 is carried out at a pressure of 25-30 MPa, a temperature of 40-60°C, and a time of 40-60 min.

7. The use according to claim 5, characterized in that The microwave-assisted extraction in step S4 has a power of 700-900 W and a frequency of 2400-2600 MHz.

8. The use according to claim 5, characterized in that The ultrasonic enhanced extraction in step S4 has a frequency of 30-50 kHz and a power of 200-400 W.

9. The use according to claim 5, characterized in that The high-pressure steam explosion pressure in step S4 is 0.5-0.9 MPa and is maintained for 4-6 minutes.

10. The use according to claim 5, characterized in that The auxiliary materials in step S6 are 10-20 parts of dextrin and 30-50 parts of mannitol.

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