A pharmaceutical composition for preventing and treating viral respiratory infection and use thereof

Abstract

The application provides a pharmaceutical composition which is prepared from raw materials in the following weight proportions: Gualoupi 10-20 parts, apricot kernel 5-15 parts, Jiegeng 10-20 parts, Gancao 5-15 parts, Jingjie 10-20 parts, Fangfeng 10-20 parts, Houpu 10-20 parts, Huangqi 10-15 parts, Chaihu 10-20 parts, Cang'erzi 10-20 parts, Baizhi 5-15 parts, Mai'mai 15-20 parts and Muxiang 10-15 parts. The composition has the effects of relieving exterior and dispelling wind, promoting lung and reducing sputum, and moving qi and relieving pain. The composition has obvious improvement effects on the symptoms of cough, expectoration, chest distress, itching or sore throat, nasal obstruction or rhinorrhea, itching or pain of ear and heart caused by viral respiratory infection, has small toxic and side effects, and has clinical application value.

Description

TECHNICAL FIELD

[0001] The application belongs to the field of traditional Chinese medicine, and particularly relates to a medicine composition for preventing and treating viral respiratory infections and application thereof. BACKGROUND

[0002] Viral Respiratory Infections (VRI) is a common clinical disease, often with epidemic and outbreak, high incidence, and a large number of patients. VRI can be caused by a variety of respiratory viruses, which invade the respiratory tract as the portal of entry, proliferate in the respiratory mucosa epithelial cells, and cause local infection of the respiratory tract or lesions of tissues and organs other than the respiratory tract; the invasion of the upper respiratory tract can cause diseases such as pharyngolaryngitis and sinusitis, and the invasion of the lower respiratory tract can cause pulmonary infectious diseases, such as respiratory virus pneumonia. Common respiratory viruses include influenza virus, parainfluenza virus, cytomegalovirus, adenovirus, rhinovirus, coronavirus, and some enteroviruses such as coxsackie virus and echovirus, as well as herpes simplex virus, varicella-zoster virus, rubella virus, measles virus, etc., and infants and young children often develop pneumonia due to respiratory syncytial virus infection. In addition, some enteroviruses such as coxsackie virus and echovirus can also cause pneumonia symptoms through respiratory infection; they pose a threat to the health of patients and have a certain degree of harm to agricultural and industrial production.

[0003] At present, the treatment of VRI is mainly supportive treatment, and high-risk groups are supplemented with antiviral drug treatment. Common broad-spectrum antiviral drugs include interferon (mainly used for respiratory syncytial virus, influenza virus, herpes virus, etc.), ribavirin (often used in combination with oseltamivir, etc.), and arbidol (mainly used for influenza A and B virus, new coronavirus, etc.), but such antiviral drugs have the problem of resistance to respiratory viruses, and can cause serious side effects.

[0004] Compared with western medicine antiviral drugs, traditional Chinese medicine has unique advantages such as small side effects and less drug resistance, and has gained more and more attention. Respiratory viral infectious diseases belong to the "cold", "cough", "asthma" and "asthma" in traditional Chinese medicine. Although there are currently few reports of traditional Chinese medicine prescriptions for treating viral respiratory infections, the effect is still poor. For example, the Chinese patent application CN106421314A discloses a pharmaceutical composition for treating viral respiratory infections, which is made of ten kinds of drugs such as perilla leaf, ginger magnolia, schizonepeta, purple wood, apricot kernel, fried perilla seed, rhizoma anemarrhena, zhebei, arctium lappa and licorice. The effective rate of improving clinical symptoms such as internal fever, cough, expectoration, hoarseness, sore throat, adverse qi and rapid breathing is less than 80%. The commercially available anti-viral granules (Z20010127) of Lishu Pharmaceutical Sichuan Guangda Pharmaceutical Co., Ltd. are mainly composed of: radix isatidis, forsythia, gypsum, rhizoma anemarrhena, radix ophiopogonis, radix rehmanniae, pachystachys jamaicensis, rhizoma acori graminei, and radix curcumae. The auxiliary materials are dextrin, sodium cyclohexylsulfamate, pachystachys jamaicensis oil, menthol oil and angelica dahurica tincture; have the effects of clearing heat and removing dampness, cooling blood and detoxifying, and can be used for treating wind-heat cold, upper respiratory tract infection and influenza, but the therapeutic effect on upper respiratory tract infection needs to be further enhanced.

[0005] In order to further expand the application of traditional Chinese medicine and provide more clinical options for the treatment of viral respiratory infections, it is necessary to further study traditional Chinese medicine prescriptions with excellent effects. SUMMARY

[0006] The purpose of the present application is to provide a pharmaceutical composition for preventing and treating viral respiratory infections.

[0007] The present application provides a pharmaceutical composition made of raw materials in the following weight proportions:

[0008] Gualoupi 10-20 parts, apricot kernel 5-15 parts, jiegeng 10-20 parts, licorice 5-15 parts, schizonepeta 10-20 parts, fuzi 10-20 parts, magnolia 10-20 parts, radix scrophulariae 10-15 parts, radix bupleuri 10-20 parts, semen crotonis 10-20 parts, radix angelicae dahuricae 5-15 parts, malt 15-20 parts, radix aucklandiae 10-15 parts.

[0009] Further, the above-mentioned pharmaceutical composition is made of raw materials in the following weight proportions:

[0010] Gualoupi 10-20 parts, apricot kernel 5-15 parts, jiegeng 10-20 parts, licorice 5-15 parts, schizonepeta 10-20 parts, fuzi 10-20 parts, magnolia 10-20 parts, radix scrophulariae 10-15 parts, radix bupleuri 10-20 parts, semen crotonis 10-20 parts, radix angelicae dahuricae 5-15 parts, malt 15-20 parts, radix aucklandiae 10-15 parts.

[0011] Further, the above-mentioned licorice is raw licorice; the radix bupleuri is bamboo-leaf radix bupleuri; the malt is roasted malt; and the radix aucklandiae is Sichuan radix aucklandiae.

[0012] Further, the above-mentioned pharmaceutical composition is a preparation prepared by adding pharmaceutically acceptable adjuvants to the raw drug powder, water and / or organic solvent extract of the raw drug as the active ingredient.

[0013] Further, the above-mentioned preparation is an oral preparation, preferably, the oral preparation is: a decoction, an oral liquid, a granule, a tablet, a pill, a capsule, a decocted extract or a syrup; the tablet includes: a compressed tablet, a chewable tablet, an effervescent tablet, a coated tablet or a buccal tablet; the pill includes a water-flooding pill, a honeyed pill or a dripping pill.

[0014] The present application also provides the use of the above-mentioned pharmaceutical composition in the preparation of a medicine for preventing and treating viral respiratory infections.

[0015] Further, the above-mentioned medicine is a medicine for preventing and treating cough, expectoration, chest tightness, throat itching, sore throat, nasal congestion, runny nose, ear itching and / or ear pain caused by viral respiratory infections.

[0016] The present application has the following beneficial effects: In the present application, Gualoupi clears heat phlegm and benefits qi to relieve chest tightness; Xingren reduces qi to stop cough and relieve asthma; Rizengxiang promotes lung and relieves phlegm; Shenggancao eliminates phlegm and stops cough; Jingjie and Fangfeng dispel wind-evil from the body surface; Houpao dries dampness to eliminate phlegm and lower qi to relieve asthma; Huangqi purges fire and detoxifies; Zhuyechai dispels pathogenic factors from the exterior and harmonizes the interior; Cang'erzi and Baizhi dispel wind-cold and open the nasal orifice; Chao Maiya promotes digestion and prevents food accumulation, which leads to lung and spleen deficiency and prolonged illness; Chuanmuxiang promotes qi and stops pain. The whole prescription has the effects of dispelling pathogenic factors from the body surface, promoting lung and eliminating phlegm, promoting qi and stopping pain. It has obvious improvement effects on cough, expectoration, chest tightness, throat itching or sore throat, nasal congestion or runny nose, ear itching or pain caused by viral respiratory infections, has small toxic and side effects, and has clinical application value.

[0017] The relationship between the monarch, the minister, the assistant and the messenger is as follows:

[0018] Monarch: Gualoupi is the monarch drug, which clears heat phlegm and benefits qi to relieve chest tightness;

[0019] Minister: Xingren, Rizengxiang, Shenggancao, Jingjie, Fangfeng, Huangqi, Cang'erzi, Baizhi and Chuanmuxiang are the minister drugs. Xingren and Rizengxiang promote lung qi and help the monarch drug to benefit qi to relieve chest tightness; Shenggancao eliminates phlegm and stops cough, which helps the monarch drug to clear phlegm and relieve chest tightness; Jingjie and Fangfeng dispel wind-evil from the body surface and disperse superficial pathogenic factors; Huangqi purges fire and detoxifies, which helps the monarch drug to clear heat phlegm; Cang'erzi and Baizhi dispel wind-cold and open the nasal orifice, which treat the accompanying symptoms; Chuanmuxiang promotes qi and stops pain, which treats the accompanying symptoms and helps the monarch drug to benefit qi to relieve chest tightness.

[0020] Assistant: Houpao and Chao Maiya are the assistant drugs. Houpao dries dampness to eliminate phlegm and lower qi to relieve asthma, which assists the monarch and minister drugs to enhance the therapeutic effect; Chao Maiya promotes digestion and prevents food accumulation, which leads to lung and spleen deficiency and prolonged illness, and also enhances the therapeutic effect of the monarch and minister drugs.

[0021] Messenger: Zhuyechai is the messenger drug, which dispels pathogenic factors from the exterior and harmonizes the interior, and can lead the other drugs in the prescription to the disease site.

[0022] Obviously, according to the above content of the present application, according to the ordinary technical knowledge and means in the art, other various forms of modification, replacement or change can be made without departing from the above basic technical idea of the present application.

[0023] The above content of the present application is further explained in detail through the following specific embodiments. However, it should not be understood that the scope of the above subject matter of the present application is limited to the following examples. Any technology realized based on the above content of the present application belongs to the scope of the present application. DETAILED DESCRIPTION

[0024] The raw materials and equipment used in the present application are known products, which are obtained by purchasing commercially available products.

[0025] Example 1, preparation of the oral liquid of the pharmaceutical composition of the present application

[0026] Raw materials: Gualoupi 15g, apricot kernel 10g, Jiegeng 15g, Shenggancao 10g, Jingjie 15g, Fangfeng 15g, Hupu 15g, Huangqi 15g, Zhuye Chaihu 15g, Cang'ersi 15g, Baizhi 10g, Fried wheat 15g, Chuanmuxiang 15g.

[0027] According to the above dosage, each raw material is taken and decocted with water to obtain decocted liquid.

[0028] Example 2, preparation of the granules of the pharmaceutical composition of the present application

[0029] Raw materials: Gualoupi 15g, apricot kernel 10g, Jiegeng 15g, Shenggancao 10g, Jingjie 15g, Fangfeng 15g, Hupu 15g, Huangqi 15g, Zhuye Chaihu 15g, Cang'ersi 15g, Baizhi 10g, Fried wheat 15g, Chuanmuxiang 15g.

[0030] According to the above dosage, each raw material is taken and decocted with water to obtain decocted liquid. The liquid is concentrated, dried and crushed to obtain extract powder. The pharmaceutically acceptable excipients, flavoring agents, etc. are added to granulate and dry to obtain granules.

[0031] Example 3, preparation of the tablets of the pharmaceutical composition of the present application

[0032] Raw materials: Gualoupi 15g, apricot kernel 10g, Jiegeng 15g, Shenggancao 10g, Jingjie 15g, Fangfeng 15g, Hupu 15g, Huangqi 15g, Zhuye Chaihu 15g, Cang'ersi 15g, Baizhi 10g, Fried wheat 15g, Chuanmuxiang 15g.

[0033] According to the above dosage, each raw material is taken and decocted with water to obtain decocted liquid. The liquid is concentrated, granulated, and added with pharmaceutically acceptable excipients, wetting agents, and binding agents, disintegrating agents, etc. to press into tablets to obtain tablets.

[0034] Example 4, Preparation of the pharmaceutical composition capsule of the present application

[0035] Raw materials: Gualoupi 10g, apricot kernel 5g, Jiegeng 10g, Shenggancao 5g, Jingjie 10g, Fangfeng 10g, Hupu 10g, Huangqi 15g, Zhuye Chaihu 10g, Cang'ersi 10g, Baizhi 5g, Fried Maimendan 15g, Chuanmuxiang 15g.

[0036] According to the above dosage, each raw material is decocted with water to obtain decoction liquid, which is concentrated, and then pharmaceutically acceptable adjuvants, flavoring agents, etc. are added for granulation, and the granules are filled into capsules on a capsule filling machine.

[0037] The beneficial effects of the present application are demonstrated by the following experimental examples.

[0038] Experimental Example 1, Therapeutic effect of the pharmaceutical composition of the present application

[0039] 1. Experimental method

[0040] 1.1 Clinical trial design, grouping

[0041] This experiment adopts a randomized, controlled trial design. It is divided into a treatment group and a control group, each with 20 cases.

[0042] 1.2 Diagnosis criteria:

[0043] (1) Diagnosis criteria: meet the diagnosis criteria of acute viral respiratory tract infection, accompanied by symptoms such as cough, expectoration, chest tightness, itching, sore throat, nasal congestion, runny nose, ear itching and / or ear pain.

[0044] Inclusion criteria:

[0045] 1) Meet the above diagnosis criteria of acute viral respiratory tract infection and accompanying symptoms;

[0046] 2) Age 18-80 years old;

[0047] 3) The patient can cooperate with the researchers in all aspects;

[0048] 4) The patient and his family sign the informed consent form.

[0049] Exclusion criteria:

[0050] 1) Diagnosis does not meet the diagnosis criteria of acute viral respiratory tract infection, or meets the diagnosis criteria but does not have symptoms such as cough, expectoration, chest tightness, itching, sore throat, nasal congestion, runny nose, ear itching and / or ear pain.

[0051] 2) Combined with severe infectious diseases, shock, immune system, hematopoietic system diseases and tuberculosis, tumors;

[0052] 3) Moderate to severe liver and kidney dysfunction;

[0053] 4) Allergic to the drugs used in this study;

[0054] 5) Participating in other clinical trials;

[0055] 6) Psychotic patients;

[0056] 7) Pregnant and lactating women;

[0057] 8) Not signing the informed consent or unable to complete the trial.

[0058] 1.3 Treatment regimen:

[0059] Control group: Antiviral granules.

[0060] Test group: The pharmaceutical composition of the present application.

[0061] Specific treatment method:

[0062] (1) Antiviral granules: 4g (one bag) each time, 3 times a day, and wash with boiling water (Lizhu Medicine Sichuan Guangda Pharmaceutical Co., Ltd., National Drug Code Z20010127.

[0063] (2) The pharmaceutical composition of the present application: The drugs in the pharmaceutical composition of the present application are decocted according to the fixed dose, and 450ml of decoction liquid is obtained, 150ml each time, 3 times a day for oral administration.

[0064] The above treatment time is 7 days.

[0065] 1.4 Observation index:

[0066] (1) Efficacy observation index

[0067] Improvement of clinical symptoms and TCM syndrome score.

[0068] (2) TCM clinical efficacy standard:

[0069] According to the syndrome efficacy judgment standard of Guiding Principles for Clinical Research on New Drugs of Traditional Chinese Medicine.

[0070] Clinical recovery: clinical symptoms disappear or basically disappear, and syndrome score reduction ≥95%;

[0071] Marked effect: clinical symptoms are significantly improved, and syndrome score reduction ≥70%;

[0072] Effective: clinical symptoms are improved, and syndrome score reduction ≥30%;

[0073] Ineffective: clinical symptoms have no obvious improvement or even aggravation, and syndrome score reduction is less than 30%.

[0074] 2, Test results

[0075] The scores of cough, expectoration, chest tightness, nasal congestion, rhinorrhea, ear and heart itching or ear and heart pain, TCM syndrome score and total effective rate in the test group were all better than those in the control group (all P<0.05); the improvement of sore throat was similar (P>0.05). See Tables 1-9.

[0076] Table 1: Scores of cough before and after treatment

[0077]

[0078] Table 2: Expectoration before and after treatment

[0079]

[0080] Table 3: Chest tightness before and after treatment

[0081]

[0082] Table 4: Sore throat before and after treatment

[0083]

[0084] Table 5: Nasal congestion before and after treatment

[0085]

[0086] Table 6: Rhinorrhea before and after treatment

[0087]

[0088] Table 7: Ear and heart itching or ear and heart pain before and after treatment

[0089]

[0090] Table 8: Comparison of TCM syndrome scores before and after treatment

[0091]

[0092] Table 9: Comparison of clinical efficacy before and after treatment

[0093]

[0094] 3. Conclusion

[0095] The drug composition of the application has excellent curative effect on acute viral respiratory infection, and is even better than the commercially available anti-viral granules.

[0096] In conclusion, the present application provides a traditional Chinese medicine preparation which is prepared from Gualoupi, apricot kernel, Platycodonis, raw licorice, Schizonepeta, Saposhnikovia, Magnolia officinalis, Scutellaria, Bupleurum chinense, Xanthium sibiricum, Baizhi, Fried wheat, and Chuanmuxiang as raw medicinal materials. The compatibility of each medicinal ingredient is appropriate, and they complement each other to achieve the effects of relieving the exterior and dispelling wind, promoting the lung and reducing phlegm, and promoting qi and relieving pain. The preparation has a significant improvement effect on the symptoms of cough, expectoration, chest tightness, itching or sore throat, nasal congestion or rhinorrhea, and ear or heart itching or pain caused by viral respiratory tract infection, has small toxic and side effects, and has clinical application value.

Claims

1. A pharmaceutical composition for preventing and treating viral respiratory tract infections, characterized in that: Made from the following raw materials in parts by weight: 10-20 parts of Trichosanthes peel, 5-15 parts of apricot kernel, 10-20 parts of Platycodon grandiflorum, 5-15 parts of liquorice, 10-20 parts of Schizonepeta tenuifolia, 10-20 parts of Saposhnikovia divaricata, 10-20 parts of Magnolia officinalis, 10-15 parts of Scutellaria baicalensis, 10-20 parts of Bupleurum chinense, 10-20 parts of Xanthium sibiricum fruit, 5-15 parts of Angelica dahurica, 15-20 parts of malt, and 10-15 parts of costus root.

2. The pharmaceutical composition according to claim 1, wherein Made from the following raw materials in parts by weight: 15 parts of Trichosanthes peels, 10 parts of Apricot kernel, 15 parts of Platycodon grandiflorum, 10 parts of Radix Glycyrrhizae, 15 parts of Herba Schizonepetae, 15 parts of Saposhnikoviae, 15 parts of Cortex Magnoliae, 15 parts of Radix Scutellariae, 15 parts of Radix Bupleuri, 15 parts of Fructus Xanthii, 10 parts of Radix Angelicae Dahuricae, 15 parts of Fructus Hordei Germinatus, 15 parts of Radix Aucklandiae.

3. The pharmaceutical composition according to claim 1 or 2, wherein The licorice is raw licorice; the bupleurum is bamboo-leaf bupleurum; the malt is roasted malt; and the costus root is Sichuan costus root.

4. The pharmaceutical composition according to claim 1 or 2, wherein The preparation is prepared by taking the raw drug powder, water and / or organic solvent extract of the raw drug as active ingredients and adding pharmaceutically acceptable excipients.

5. The pharmaceutical composition according to claim 4, wherein The preparation is an oral preparation.

6. The pharmaceutical composition according to claim 5, wherein The oral preparation is: decoction, oral liquid, granule, tablet, pill, capsule, decoction or syrup.

7. The pharmaceutical composition according to claim 6, wherein The tablets include compressed tablets; the pills include water-filled pills, honeyed pills or dripping pills.

8. The pharmaceutical composition according to claim 6, wherein The tablets include coated tablets.

9. The pharmaceutical composition according to claim 6, wherein The tablets include chewable tablets, effervescent tablets or buccal tablets.

10. Use of the pharmaceutical composition according to any one of claims 1 to 9 in the preparation of a medicament for preventing and treating viral respiratory tract infections.

11. The use according to claim 10, characterized in that The medicine is a medicine for preventing and treating cough, sputum, chest tightness, throat itching, throat pain, nasal congestion, runny nose, ear itching and / or ear pain caused by viral respiratory tract infection.

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