Traditional Chinese medicine preparation for treating pharyngitis and amygdalitis as well as preparation method and application of traditional Chinese medicine preparation

Abstract

The invention relates to the field of traditional Chinese medicine, and discloses a traditional Chinese medicine preparation for treating pharyngitis and amygdalitis and a preparation method and application thereof. The traditional Chinese medicine preparation comprises the following components in parts by weight: 6 parts of honeysuckle, 4 parts of subprostrate sophora, 4 parts of radix isatidis, 4 parts of radix scrophulariae, 3 parts of blackberry lily, 4 parts of pericarpium citri reticulatae and 2 parts of liquorice. The traditional Chinese medicine preparation can be used for treating acute and chronic pharyngitis and amygdalitis and is remarkable in curative effect, small in side effect and high in patient compliance.

Description

Technical Field

[0001] This application relates to the field of traditional Chinese medicine, and more specifically, it relates to a traditional Chinese medicine preparation for treating pharyngitis and tonsillitis, its preparation method and application. Background Art

[0002] Pharyngitis and tonsillitis are common upper respiratory tract infectious diseases clinically, mostly caused by viral or bacterial infections, mainly manifested as symptoms such as sore throat, difficulty in swallowing, fever, etc. Modern medicine mainly uses antibiotics, antiviral drugs or antipyretics for treatment, but long-term use may lead to problems such as drug resistance, gastrointestinal adverse reactions and immunosuppression. In addition, some patients have poor responses to western medicine treatment or are prone to recurrence, and there is an urgent need for safer and more effective alternative therapies.

[0003] Traditional Chinese medicine has a long history and rich experience in treating throat diseases. Traditional Chinese medicine compound preparations can exert anti-inflammatory, antibacterial, analgesic and immunomodulatory effects through the synergistic effects of multiple components and multiple targets, and have relatively few side effects.

[0004] Therefore, providing a traditional Chinese medicine preparation for acute and chronic pharyngitis and tonsillitis with significant curative effects, few side effects and high patient compliance can provide a better choice for the treatment of pharyngitis and tonsillitis. Summary of the Invention

[0005] The invention purpose of this application is to provide a traditional Chinese medicine preparation for acute and chronic pharyngitis and tonsillitis with significant curative effects, few side effects and high patient compliance.

[0006] In order to achieve the above invention purpose, this application adopts the following technical solutions:

[0007] In the first aspect, this application provides a traditional Chinese medicine preparation, calculated by weight, including 5 - 7 parts of honeysuckle flower, 3 - 5 parts of sophora subprostrata root, 3 - 5 parts of isatis root, 3 - 5 parts of scrophularia root, 2 - 4 parts of belamcanda root, 3 - 5 parts of dried tangerine peel, and 1 - 3 parts of liquorice root.

[0008] Preferably, the traditional Chinese medicine preparation, calculated by weight, includes 6 parts of honeysuckle flower, 4 parts of sophora subprostrata root, 4 parts of isatis root, 4 parts of scrophularia root, 3 parts of belamcanda root, 4 parts of dried tangerine peel, and 2 parts of liquorice root.

[0009] In the second aspect, this application provides a preparation method of the traditional Chinese medicine preparation described in the first aspect, including the following steps: The above seven herbs are respectively decocted with water 1 - 3 times, the decoction liquid is filtered, combined, allowed to stand, the supernatant is taken and filtered, the filtrate is concentrated, medicinal adjuvants are added, boiled, water is added, filtered, filled, and sterilized to obtain the product.

[0010] Preferably, the medicinal adjuvants, calculated by weight, include 2 parts of sucrose, 0.01 part of sodium benzoate, and 0.01 part of ethylparaben.

[0011] Preferably, the preparation method of the traditional Chinese medicine preparation is characterized by comprising the following steps: The above seven herbs are respectively decocted with 8 times the amount of water twice. The first decoction is for 2 hours and the second is for 1.5 hours. The decoction liquid is filtered, combined, allowed to stand, and the supernatant is taken and filtered. The filtrate is concentrated to 20 parts, 2 parts of sucrose, 0.01 part of sodium benzoate and 0.01 part of ethylparaben are added, boiled, water is added to make 20 parts, filtered, filled, and sterilized to obtain the product.

[0012] In the third aspect, the present application provides the use of the traditional Chinese medicine preparation in the first aspect in the preparation of drugs for treating pharyngitis and tonsillitis.

[0013] For the diseases such as pharyngitis and tonsillitis treated by this prescription, they are mostly caused by external pathogenic factors invading and accumulating in the throat to transform into heat, manifested as sore throat, discomfort in swallowing, dry mouth and cough; or caused by yin deficiency and fluid depletion, and overeating spicy and fatty foods, manifested as dry and burning pain in the throat, sticky and less phlegm, and thirst with a preference for drinking. The treatment should be to clear heat and soothe the throat, reduce swelling and promote fluid production. In this prescription, Flos Lonicerae japonicae clears heat and detoxifies, disperses wind-heat, is good at entering the lung meridian to disperse pathogenic factors, is sweet and cold to clear and purge, and can transform heat and conduct qi, and is a good medicine for clearing heat and detoxifying, and is the monarch drug; Radix Isatidis clears heat and detoxifies, cools blood and soothes the throat, is good at clearing real fire toxin, Radix Sophorae tonkinensis clears heat and detoxifies, reduces swelling and soothes the throat, is good at clearing lung fire, and is an important drug for treating sore throat, Belamcanda chinensis clears heat and detoxifies, reduces phlegm and soothes the throat. The three drugs are used together to achieve the effect of clearing heat and soothe the throat, and are the ministerial drugs; Pericarpium Citri reticulatae regulates qi and strengthens the spleen, reduces phlegm, Scrophulariae ningpoensis clears heat and cools blood, purges fire and detoxifies, nourishes yin, and they are both assistant drugs; Glycyrrhiza uralensis Fisch. Tonifies the spleen and benefits qi, relieves cough, and harmonizes various drugs, and is the guiding drug. The whole prescription clears heat and detoxifies, supplemented by multiple herbs for clearing the throat and soothing the throat, taking into account regulating qi and reducing phlegm, nourishing yin and promoting fluid production, so that heat is cleared, swelling is reduced, and all symptoms are treated. Specific Embodiments

[0014] The technical solutions and effects of the present application are further described in detail below in conjunction with embodiments. It can be understood that the specific embodiments described herein are only used to explain the invention-creation, rather than limiting the invention-creation. It is worth noting that the materials or instruments used in the following embodiments are all commercially available unless otherwise specified.

[0015] Example 1

[0016] The present application example discloses a traditional Chinese medicine preparation, and the raw materials used in its preparation are:

[0017] 300 g of Flos Lonicerae japonicae; 200 g of Radix Sophorae tonkinensis; 200 g of Radix Isatidis; 200 g of Scrophulariae ningpoensis; 150 g of Belamcanda chinensis; 200 g of Pericarpium Citri reticulatae; 100 g of Glycyrrhiza uralensis Fisch.

[0018] The preparation process of this traditional Chinese medicine preparation is as follows:

[0019] The above seven herbs are each decocted twice with 8 times their amount of water. The first decoction is for 2 hours and the second for 1.5 hours. The decoctions are filtered, combined, allowed to stand, and the supernatant is filtered. The filtrate is concentrated to approximately 1000 ml, 100 g of sucrose, 0.5 g of sodium benzoate, and 0.5 g of ethylparaben are added, boiled for 15 minutes, diluted with water to 1000 ml, filtered, filled into containers, and sterilized to obtain the product.

[0020] Example 2

[0021] This example of the present application discloses a traditional Chinese medicine preparation, and the raw materials used in its preparation are as follows:

[0022] Flos Lonicerae 250 g; Radix Sophorae Tonkinensis 150 g; Radix Isatidis 150 g; Radix Scrophulariae 150 g; Rhizoma Belamcandae 100 g; Pericarpium Citri Reticulatae 150 g; Radix Glycyrrhizae 50 g.

[0023] The preparation process of this traditional Chinese medicine preparation is as follows:

[0024] The above seven herbs are each decocted twice with 8 times their amount of water. The first decoction is for 2 hours and the second for 1.5 hours. The decoctions are filtered, combined, allowed to stand, and the supernatant is filtered. The filtrate is concentrated to approximately 1000 ml, 100 g of sucrose, 0.5 g of sodium benzoate, and 0.5 g of ethylparaben are added, boiled for 15 minutes, diluted with water to 1000 ml, filtered, filled into containers, and sterilized to obtain the product.

[0025] Example 3

[0026] This example of the present application discloses a traditional Chinese medicine preparation, and the raw materials used in its preparation are as follows:

[0027] Flos Lonicerae 350 g; Radix Sophorae Tonkinensis 250 g; Radix Isatidis 250 g; Radix Scrophulariae 250 g; Rhizoma Belamcandae 200 g; Pericarpium Citri Reticulatae 250 g; Radix Glycyrrhizae 150 g.

[0028] The preparation process of this traditional Chinese medicine preparation is as follows:

[0029] The above seven herbs are each decocted twice with 8 times their amount of water. The first decoction is for 2 hours and the second for 1.5 hours. The decoctions are filtered, combined, allowed to stand, and the supernatant is filtered. The filtrate is concentrated to approximately 1000 ml, 100 g of sucrose, 0.5 g of sodium benzoate, and 0.5 g of ethylparaben are added, boiled for 15 minutes, diluted with water to 1000 ml, filtered, filled into containers, and sterilized to obtain the product.

[0030] Example 4

[0031] This example of the present application discloses a traditional Chinese medicine preparation, and the raw materials used in its preparation are as follows:

[0032] Flos Lonicerae 300 g; Radix Sophorae Tonkinensis 150 g; Radix Isatidis 200 g; Radix Scrophulariae 175 g; Rhizoma Belamcandae 150 g; Pericarpium Citri Reticulatae 200 g; Radix Glycyrrhizae 100 g.

[0033] The preparation process of this traditional Chinese medicine preparation is as follows:

[0034] The above seven herbs are each decocted with 8 times their amount of water twice. The first decoction is for 2 hours and the second for 1.5 hours. The decoction liquids are filtered, combined, allowed to stand, and the supernatant is filtered. The filtrate is concentrated to approximately 1000 ml, 100 g of sucrose, 0.5 g of sodium benzoate, and 0.5 g of ethylparaben are added, boiled for 15 minutes, diluted with water to 1000 ml, filtered, filled, and sterilized to obtain the product.

[0035] Example 5

[0036] This example of the present application discloses a traditional Chinese medicine preparation, and the raw materials used in its preparation are as follows:

[0037] Flos Lonicerae 300 g; Radix Sophorae Tonkinensis 200 g; Radix Isatidis 250 g; Radix Scrophulariae 200 g; Rhizoma Belamcandae 100 g; Pericarpium Citri Reticulatae 200 g; Radix Glycyrrhizae 100 g.

[0038] The preparation process of this traditional Chinese medicine preparation is as follows:

[0039] The above seven herbs are each decocted with 8 times their amount of water twice. The first decoction is for 2 hours and the second for 1.5 hours. The decoction liquids are filtered, combined, allowed to stand, and the supernatant is filtered. The filtrate is concentrated to approximately 1000 ml, 100 g of sucrose, 0.5 g of sodium benzoate, and 0.5 g of ethylparaben are added, boiled for 15 minutes, diluted with water to 1000 ml, filtered, filled, and sterilized to obtain the product.

[0040] Performance Testing

[0041] 1.1 Research Subjects

[0042] The cases for this trial were collected from January 2024 to December 2024. The sources were outpatients of Zhongshan Hospital, Fudan University. The enrolled subjects were all clinically diagnosed as patients with acute and chronic pharyngitis and tonsillitis. They voluntarily signed the informed consent form to participate in the trial and were adult populations judged by clinicians to have no contraindications to the use of the drug. Finally, a total of 85 subjects met the case inclusion criteria and completed the observation.

[0043] 1.2 Inclusion Criteria

[0044] Ages 18 - 70 years old, gender not restricted;

[0045] Agreed to participate in this study and signed the informed consent form, and were able to follow the doctor's advice on taking the medicine and return for follow-up visits on time.

[0046] 1.3 Exclusion Criteria

[0047] Patients allergic to the research drug;

[0048] Patients who have used other drugs for treatment in the past 4 weeks;

[0049] Patients with mental abnormalities and unconsciousness, etc.;

[0050] Pregnant or lactating women;

[0051] Patients with other serious diseases that may affect the research results or treatment effects should be excluded.

[0052] 1.4 Treatment method: Orally take the traditional Chinese medicine preparation prepared in Example 1, 10 ml each time, 3 times a day.

[0053] 1.5 Efficacy evaluation methods and indicators

[0054] Evaluate according to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines";

[0055] Marked effect: Efficacy index ≥ 60.0%;

[0056] Effective: 20.0% ≤ Efficacy index < 60.0%;

[0057] Ineffective: Efficacy index < 20.0%.

[0058] 1.6 Results

[0059] As shown in the following table.

[0060]

[0061] 1.7 Typical cases

[0062] Case 1: Patient Zhang, male, 31 years old, clinically diagnosed with chronic pharyngitis;

[0063] Persistent dryness in the throat, foreign body sensation, repeated dry cough or a small amount of sticky sputum, especially aggravated when stimulated by cold air, lampblack, etc.; After 2 weeks of treatment, the dryness in the throat and foreign body sensation basically disappeared, the cough completely stopped, and the sputum secretion normalized; Marked effect.

[0064] Case 2: Patient Fu, male, 51 years old, clinically diagnosed with chronic tonsillitis;

[0065] Dull pain or discomfort in the tonsil area, possible slight pain or foreign body sensation when swallowing; After 2 weeks of treatment, the throat pain and foreign body sensation were basically eliminated, there was no repeated infection, and the surface of the tonsils was clean; Marked effect.

[0066] Case 3: Patient Zhang, female, 28 years old, clinically diagnosed with acute pharyngitis;

[0067] Severe throat pain, which is aggravated when swallowing and even affects eating (especially hot, sour, and hard foods); After 2 weeks of treatment, the throat pain was significantly reduced and normal swallowing was possible; Marked effect.

[0068] 1.8 Conclusions

[0069] The traditional Chinese medicine preparation of the present application can be used for acute and chronic pharyngitis and tonsillitis, with remarkable curative effects, few side effects and high patient compliance.

[0070] This specific embodiment is only an interpretation of the present application and does not limit the present application. Those skilled in the art can make modifications to this embodiment without creative contributions according to needs after reading this specification, but as long as it is within the scope of the claims of the present application, it is protected by the patent law.

Claims

1. A traditional Chinese medicine preparation, characterized in that, Calculated by weight parts, it includes 5-7 parts of honeysuckle flower, 3-5 parts of sophora root, 3-5 parts of isatis root, 3-5 parts of scrophularia root, 2-4 parts of belamcanda root, 3-5 parts of dried tangerine peel, and 1-3 parts of liquorice root.

2. The traditional Chinese medicine preparation according to claim 1, characterized in that, Calculated by weight parts, it includes 6 parts of honeysuckle flower, 4 parts of sophora root, 4 parts of isatis root, 4 parts of scrophularia root, 3 parts of belamcanda root, 4 parts of dried tangerine peel, and 2 parts of liquorice root.

3. The preparation method of the traditional Chinese medicine preparation according to claim 1 or 2, characterized in that, It includes the following steps: For the above seven herbs, each is decocted with water 1-3 times respectively. The decoction liquid is filtered, combined, allowed to stand, the supernatant is taken and filtered, the filtrate is concentrated, medicinal adjuvants are added, boiled, water is added, filtered, filled, and sterilized to obtain the product.

4. The preparation method of the traditional Chinese medicine preparation according to claim 3, characterized in that, The said medicinal adjuvants, calculated by weight parts, include 2 parts of sucrose, 0.01 part of sodium benzoate, and 0.01 part of ethylparaben.

5. The preparation method of the traditional Chinese medicine preparation according to claim 4, characterized in that, It includes the following steps: For the above seven herbs, each is decocted with 8 times the amount of water 2 times respectively. The first decoction is for 2 hours and the second decoction is for 1.5 hours. The decoction liquid is filtered, combined, allowed to stand, the supernatant is taken and filtered, the filtrate is concentrated to 20 parts, 2 parts of sucrose, 0.01 part of sodium benzoate, and 0.01 part of ethylparaben are added, boiled, water is added to 20 parts, filtered, filled, and sterilized to obtain the product.

6. Use of the traditional Chinese medicine preparation according to claim 1 or 2 in the preparation of a medicament for treating pharyngitis and tonsillitis.

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