A traditional Chinese medicine composition with throat-soothing and cough-relieving effects and its preparation method

Abstract

This invention belongs to the field of traditional Chinese medicine technology, and provides a traditional Chinese medicine composition with the effects of clearing the throat and relieving cough, and its preparation method. The traditional Chinese medicine composition contains the following components: Scrophularia ningpoensis, Ophiopogon japonicus, Platycodon grandiflorus, Terminalia chebula, Mentha haplocalyx, Paeonia lactiflora, Glycyrrhiza uralensis, Borneol, and rice wine. This traditional Chinese medicine composition nourishes Yin and moistens dryness, cools the blood and reduces swelling, clears the throat and relieves cough, and can effectively improve symptoms such as sore throat, foreign body sensation in the throat, hoarseness, dry and itchy throat, and irritating dry cough caused by endotracheal intubation or gastric tube placement. This traditional Chinese medicine composition has definite efficacy, high safety, and few side effects, and has excellent clinical application and industrialization prospects.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, and relates to a traditional Chinese medicine composition with the effects of clearing the throat and relieving cough, and its preparation method. Background Technology

[0002] Endotracheal intubation and gastric tube insertion are common invasive diagnostic and treatment procedures in clinical anesthesia, intensive care, gastroenterology, and the perioperative period. While saving patients' lives and ensuring the smooth progress of clinical treatment, they can easily cause iatrogenic damage to the pharyngeal mucosa. During the insertion of endotracheal tubes or gastric tubes through the pharynx, mechanical friction and pressure can directly damage the pharyngeal and vocal cord mucosal epithelium, causing mucosal congestion, edema, and micro-erosions. Postoperatively, a series of complications are likely to occur, including sore throat, a feeling of foreign body obstruction in the throat, hoarseness, dry and itchy throat, irritating dry cough, and dryness and discomfort in the throat. The clinical incidence is relatively high.

[0003] Currently, clinical treatment for these symptoms mainly involves symptomatic treatments such as nebulized inhalation, mouthwash, and oral anti-inflammatory and antitussive drugs. However, these methods have limitations, slow onset of action, significant side effects from systemic medication, and the potential for drug resistance with long-term use. Existing oral Chinese medicine preparations mainly focus on treating chronic pharyngitis and coughs caused by external pathogens, lacking specific drugs for acute traumatic pharyngitis induced by mechanical injury. Furthermore, oral administration requires gastrointestinal metabolism, resulting in low local drug concentrations in the throat and limited efficacy.

[0004] Traditional Chinese medicine considers iatrogenic pharyngeal mucosal injury to fall under the category of "injury from a metal blade." After intubation, the pharyngeal vessels are damaged, leading to stagnation of qi and blood, lung and stomach heat accumulation, upward flaring of deficient fire, and phlegm and qi stagnation, resulting in symptoms such as sore throat, hoarseness, itchy throat, dry cough, and a foreign body sensation. Existing topical throat-soothing preparations have single-formula compositions and lack a comprehensive approach that addresses heat-clearing, throat-soothing, blood-activating, swelling-reducing, dryness-relieving, cough-suppressing, and voice-enhancing properties. Therefore, they are insufficient to simultaneously improve multiple pathological manifestations such as postoperative mucosal damage, inflammatory edema, vocal cord damage, and irritating cough.

[0005] Therefore, developing a topical traditional Chinese medicine composition that can quickly relieve sore throat, hoarseness, irritating dry cough, and foreign body sensation in the throat after endotracheal intubation or gastric tube insertion has important clinical application value. Summary of the Invention

[0006] To address the shortcomings of existing technologies, this invention provides a traditional Chinese medicine composition with throat-clearing and cough-relieving effects and its preparation method.

[0007] In a first aspect, the present invention provides a traditional Chinese medicine composition having the effect of clearing the throat and relieving cough, the traditional Chinese medicine composition comprising the following components: Scrophularia ningpoensis, Ophiopogon japonicus, Platycodon grandiflorus, Terminalia chebula, Mentha haplocalyx, Paeonia lactiflora, Glycyrrhiza uralensis, Borneol, and rice wine.

[0008] As some preferred technical solutions of the present invention, the following components are contained in parts by weight: 8-12 parts of Scrophularia ningpoensis, 8-12 parts of Ophiopogon japonicus, 8-12 parts of Platycodon grandiflorus, 8-12 parts of Terminalia chebula, 4-8 parts of Mentha haplocalyx, 4-8 parts of Paeonia lactiflora, 4-8 parts of Glycyrrhiza uralensis, 0.5-1.5 parts of Borneol, and 48-55 parts of Shaoxing wine.

[0009] As a preferred technical solution of the present invention, the following components are contained by weight: 10 parts of Scrophularia ningpoensis, 10 parts of Ophiopogon japonicus, 10 parts of Platycodon grandiflorus, 10 parts of Terminalia chebula, 6 parts of Mentha haplocalyx, 6 parts of Paeonia lactiflora, 6 parts of Glycyrrhiza uralensis, 1 part of Borneol, and 50 parts of rice wine.

[0010] As a preferred technical solution of the present invention, the following components are contained by weight: 12 parts of Scrophularia ningpoensis, 10 parts of Ophiopogon japonicus, 8 parts of Platycodon grandiflorus, 12 parts of Terminalia chebula, 4 parts of Mentha haplocalyx, 8 parts of Paeonia lactiflora, 6 parts of Glycyrrhiza uralensis, 0.5 parts of Borneol, and 48 parts of Shaoxing wine.

[0011] As a preferred technical solution of the present invention, the following components are contained by weight: 8 parts of Scrophularia ningpoensis, 12 parts of Ophiopogon japonicus, 10 parts of Platycodon grandiflorus, 12 parts of Terminalia chebula, 6 parts of Mentha haplocalyx, 6 parts of Paeonia lactiflora, 7 parts of Glycyrrhiza uralensis, 1 part of Borneol, and 50 parts of rice wine.

[0012] A second aspect of the present invention provides the use of the traditional Chinese medicine composition in the preparation of a medicine having the effect of clearing the throat and relieving cough.

[0013] Furthermore, the present invention provides the use of the traditional Chinese medicine composition with the effects of clearing the throat and relieving cough in the preparation of a drug for improving iatrogenic pharyngeal mucosal injury after tracheal and gastric tube intubation.

[0014] A third aspect of the present invention provides a formulation of a medicine having the effect of clearing the throat and relieving cough, wherein the dosage form is a topical formulation.

[0015] Furthermore, the topical preparation also includes medically acceptable pharmaceutical excipients.

[0016] Furthermore, the topical preparation is selected from any one of ointments, gels, liniments, films, and sprays.

[0017] Furthermore, the topical preparation is an ointment.

[0018] In a fourth aspect, the present invention provides a method for preparing a traditional Chinese medicine composition with the effect of clearing the throat and relieving cough, comprising the following steps: weighing out Scrophularia ningpoensis, Ophiopogon japonicus, Platycodon grandiflorus, Terminalia chebula, Mentha haplocalyx, Paeonia lactiflora, Glycyrrhiza uralensis, and Borneol by weight, pulverizing them, grinding them into a fine powder, adding rice wine, stirring and mixing into a paste, and thus obtaining the product.

[0019] The complete entourage of the ruler, ministers, assistants, and envoys is as follows: (1) Chief herbs: Scrophularia and Ophiopogon japonicus - These two herbs are used in the largest quantities and specifically enter the lung meridian. Scrophularia is bitter, salty and slightly cold, clearing heat and cooling blood, nourishing yin and reducing fire, detoxifying and dispersing nodules; Ophiopogon japonicus is sweet, slightly bitter and slightly cold, nourishing yin and moistening the lungs, benefiting the stomach and generating fluids. The combination of these two herbs works together to nourish yin and moisten dryness, cool blood and reduce swelling, directly addressing the pathogenesis of throat injury, and is the main herb in the formula.

[0020] (2) Assistant herbs: Platycodon grandiflorus and Terminalia chebula - Platycodon grandiflorus promotes lung function, relieves stagnation, carries the medicine upward, and clears the throat; Terminalia chebula clears the throat, generates fluids, detoxifies, and soothes the throat. The two herbs assist the principal herbs in reaching the affected area of ​​the throat, opening the throat and dispersing nodules, and enhancing the ability to clear the throat.

[0021] (3) Adjuvant herbs: peppermint, red peony root, borneol - peppermint dispels wind and heat, clears the head and eyes, relieves throat heat, and alleviates throat itching and foreign body sensation; red peony root: cools blood and disperses blood stasis, unblocks meridians and reduces swelling, improves throat mucosal congestion and swelling, and blood stasis; borneol: pungent and aromatic, penetrates the skin and guides the meridians, opens the orifices and unblocks the meridians, promotes the skin penetration of the drug, directly reaches the acupoints and meridians, and enhances the efficacy of external application.

[0022] (4) Guiding herbs: Licorice and rice wine - Licorice harmonizes all herbs, relieves urgency and soothes the throat, clears heat and detoxifies, moderates the properties of herbs, and leads the whole prescription to perform its function; rice wine is an excipient, which mixes the powdered herbs into a paste for application, and also has the function of guiding the medicine upward and helping to penetrate and unblock the meridians.

[0023] The beneficial effects of the traditional Chinese medicine composition of this invention, which has the function of clearing the throat and relieving cough, are as follows: In this invention, the principal herbs are Scrophularia and Ophiopogon japonicus. These two herbs are sweet and cold, nourishing and moistening, specifically replenishing lung yin and clearing upward floating deficiency fire, improving the root cause of nasal and throat fluid deficiency, dryness, and burning pain. Platycodon grandiflorus and Terminalia chebula are used as assistant herbs to assist the principal herbs in directly reaching the throat, opening the throat and dispersing nodules, and enhancing the ability to clear and soothe the throat. Peppermint, Paeonia lactiflora, Borneol, Glycyrrhiza uralensis, and rice wine are used as adjuvant herbs. Glycyrrhiza uralensis moderates the properties of the herbs and leads the entire formula to perform their respective functions. Rice wine guides the herbs upward and helps to penetrate and unblock the meridians. The whole formula works together to nourish yin and moisten dryness, cool blood and reduce swelling, clear the throat and stop cough.

[0024] Pharmacodynamic experiments showed that the herbal composition of this invention effectively relieved pharyngeal redness and swelling, significantly inhibited the expression of TLR2 and TLR4, and effectively improved iatrogenic pharyngeal mucosal damage after endotracheal intubation. The herbal composition of this invention significantly reduced the number of coughs in ammonia-induced cough mice, demonstrating a significant antitussive effect.

[0025] The traditional Chinese medicine composition of this invention can effectively improve symptoms such as sore throat, foreign body obstruction in the throat, hoarseness, dry and itchy throat, and irritating dry cough caused by endotracheal intubation and gastric tube insertion.

[0026] The traditional Chinese medicine composition of this invention has definite efficacy, high safety, and few side effects, and has excellent prospects for clinical application and industrialization. Attached Figure Description

[0027] Figure 1The number of coughs in each group of mice was compared with that in the blank control group. & P <0.05, && P <0.01; compared with the model group, P <0.05, P <0.01; compared with group 1, # P <0.05, ## P <0.01. Detailed Implementation

[0028] To better understand the above technical solutions, a detailed description of the specific implementation methods will be provided below. Obviously, the described embodiments are merely some, not all, of the embodiments of the present invention. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative effort are within the scope of protection of the present invention.

[0029] It should also be noted that the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that an article or device that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such an article or device. Without further limitation, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the article or device that includes said element.

[0030] Unless otherwise specified, all raw materials and excipients of the traditional Chinese medicine composition of the present invention can be obtained commercially. Any traditional Chinese medicine composition within any range described in the present invention, including end values ​​and any values ​​between end values ​​and any sub-ranges formed by end values ​​or any values ​​between end values, can achieve the effects described in the present invention.

[0031] The term "parts by weight" in this invention specification refers to the proportion of each raw material in the traditional Chinese medicine composition. Depending on the actual application, "1 part by weight" in this invention can be "1g", "1kg" or any other arbitrary weight.

[0032] The daily dosage of the traditional Chinese medicine composition described in this invention can be adjusted according to the patient's condition.

[0033] The preparation method of the traditional Chinese medicine composition in Examples 1-7 is as follows: weigh out the following ingredients according to the weight: Scrophularia, Ophiopogon japonicus, Platycodon grandiflorus, Terminalia chebula, Mentha haplocalyx, Paeonia lactiflora, Glycyrrhiza uralensis, and Borneol, pulverize them, grind them into a fine powder, add rice wine, stir and mix into a paste, and the product is obtained.

[0034] Example 1 This embodiment provides a traditional Chinese medicine composition with the effect of clearing the throat and relieving cough, which is composed of the following raw materials: 10 parts of Scrophularia ningpoensis, 10 parts of Ophiopogon japonicus, 10 parts of Platycodon grandiflorus, 10 parts of Terminalia chebula, 6 parts of Mentha haplocalyx, 6 parts of Paeonia lactiflora, 6 parts of Glycyrrhiza uralensis, 1 part of Borneol, and 50 parts of rice wine.

[0035] Example 2 This embodiment provides a traditional Chinese medicine composition with the effect of clearing the throat and relieving cough, which is composed of the following raw materials: 12 parts of Scrophularia ningpoensis, 10 parts of Ophiopogon japonicus, 8 parts of Platycodon grandiflorus, 12 parts of Terminalia chebula, 4 parts of Mentha haplocalyx, 8 parts of Paeonia lactiflora, 6 parts of Glycyrrhiza uralensis, 0.5 parts of Borneol, and 48 parts of rice wine.

[0036] Example 3 This embodiment provides a traditional Chinese medicine composition with the effect of clearing the throat and relieving cough, which is composed of the following raw materials: 8 parts of Scrophularia ningpoensis, 12 parts of Ophiopogon japonicus, 10 parts of Platycodon grandiflorus, 12 parts of Terminalia chebula, 6 parts of Mentha haplocalyx, 6 parts of Paeonia lactiflora, 7 parts of Glycyrrhiza uralensis, 1 part of Borneol, and 50 parts of rice wine.

[0037] Example 4 This embodiment provides a traditional Chinese medicine composition with the effect of clearing the throat and relieving cough, which is composed of the following raw materials: 12 parts of Scrophularia ningpoensis, 8 parts of Ophiopogon japonicus, 12 parts of Platycodon grandiflorus, 8 parts of Terminalia chebula, 5 parts of Mentha haplocalyx, 7 parts of Paeonia lactiflora, 8 parts of Glycyrrhiza uralensis, 1.5 parts of Borneol, and 55 parts of rice wine.

[0038] Example 5 This embodiment provides a traditional Chinese medicine composition with the effect of clearing the throat and relieving cough, which is composed of the following raw materials: 10 parts of Scrophularia ningpoensis, 8 parts of Ophiopogon japonicus, 10 parts of Platycodon grandiflorus, 8 parts of Terminalia chebula, 6 parts of Mentha haplocalyx, 4 parts of Paeonia lactiflora, 6 parts of Glycyrrhiza uralensis, 1 part of Borneol, and 50 parts of rice wine.

[0039] Example 6 This embodiment provides a traditional Chinese medicine composition with the effect of clearing the throat and relieving cough, which is composed of the following raw materials: 8 parts of Scrophularia ningpoensis, 8 parts of Ophiopogon japonicus, 8 parts of Platycodon grandiflorus, 8 parts of Terminalia chebula, 8 parts of Mentha haplocalyx, 4 parts of Paeonia lactiflora, 4 parts of Glycyrrhiza uralensis, 1.5 parts of Borneol, and 48 parts of rice wine.

[0040] Example 7 This embodiment provides a traditional Chinese medicine composition with the effect of clearing the throat and relieving cough, which is composed of the following raw materials: 10 parts of Scrophularia ningpoensis, 10 parts of Ophiopogon japonicus, 10 parts of Platycodon grandiflorus, 10 parts of Terminalia chebula, 6 parts of Mentha haplocalyx, 6 parts of Paeonia lactiflora, 6 parts of Glycyrrhiza uralensis, 1 part of Borneol, and 55 parts of rice wine.

[0041] Comparative Example 1 Example 1 of Chinese Patent CN106389895A (Traditional Chinese Medicine Composition for Nourishing Yin, Clearing Lungs, Moistening Dryness and Soothing Throat, and its Preparation Method and Application) is a formulation prepared with reference to the method of this application.

[0042] Specifically, the active ingredients of the traditional Chinese medicine composition are prepared from the following raw materials in parts by weight: 14.3 parts of burdock seed, 4.9 parts of reed rhizome, 3.3 parts of Terminalia chebula fruit, 2.6 parts of Rehmannia glutinosa, 2.6 parts of Ophiopogon japonicus, 2.6 parts of Scutellaria baicalensis, 1.6 parts of Paeonia suffruticosa bark, 3.6 parts of Paeonia lactiflora, 1.6 parts of Platycodon grandiflorus, 3.6 parts of Scrophularia ningpoensis, 2.6 parts of Dendrobium nobile, 2.6 parts of Chrysanthemum morifolium, 2.6 parts of Mentha haplocalyx, 3.6 parts of Houttuynia cordata, 3.3 parts of Morus alba root bark, and 0.7 parts of Glycyrrhiza uralensis.

[0043] The preparation method is as follows: crush all the above raw materials into fine powder, add rice wine (50 parts) to make a thick paste.

[0044] Comparative Example 2 The formulation of Example 1 of Chinese Patent CN102641421A (Xuanshen Shangqing Throat Tablets) was prepared with reference to the method of this application.

[0045] Specifically, by weight, the ratio of Scrophularia ningpoensis: Arctium lappa: Ophiopogon japonicus: Terminalia chebula: Terminalia chebula: Platycodon grandiflorus: Paeonia lactiflora: Lonicera japonica: Sterculia lychnophora: Glycyrrhiza uralensis is 13:12:11:10:8:8:8:5:5:5, and the total weight of Arctium lappa, Ophiopogon japonicus, Terminalia chebula, Terminalia chebula, Platycodon grandiflorus, Paeonia lactiflora, Lonicera japonica, Sterculia lychnophora, and Glycyrrhiza uralensis is 59 parts. All the above ingredients are pulverized into a fine powder and mixed with 50 parts of rice wine to form a thick paste.

[0046] Comparative Example 3 A traditional Chinese medicine composition comprising the following ingredients: 10 parts of Scrophularia ningpoensis, 10 parts of Ophiopogon japonicus, 10 parts of Platycodon grandiflorus, 10 parts of Terminalia chebula, 6 parts of Mentha haplocalyx, 6 parts of Paeonia lactiflora, 6 parts of Glycyrrhiza uralensis, and 1 part of Borneol.

[0047] The only difference between this comparative example and Example 1 is that it does not contain rice wine and the preparation method is changed. The traditional Chinese medicine composition in this comparative example is prepared by water extraction.

[0048] Weigh the above ingredients according to their weight, add 10 times their weight of water, decoct twice, 30 minutes each time, and concentrate into a clear paste.

[0049] Comparative Example 4 A traditional Chinese medicine composition comprising the following ingredients: 6 parts of Scrophularia ningpoensis, 14 parts of Ophiopogon japonicus, 6 parts of Platycodon grandiflorus, 5 parts of Terminalia chebula, 9 parts of Mentha haplocalyx, 9 parts of Paeonia lactiflora, 9 parts of Glycyrrhiza uralensis, 1 part of Borneol, and 50 parts of rice wine.

[0050] The only difference between this comparative example and Example 1 is the change in the amount of each component.

[0051] Comparative Example 5 A traditional Chinese medicine composition comprising the following ingredients: 14 parts of Scrophularia ningpoensis, 6 parts of Ophiopogon japonicus, 5 parts of Platycodon grandiflorus, 6 parts of Terminalia chebula, 9 parts of Mentha haplocalyx, 9 parts of Paeonia lactiflora, 9 parts of Glycyrrhiza uralensis, 1 part of Borneol, and 50 parts of rice wine.

[0052] The only difference between this comparative example and Example 1 is the change in the amount of each component.

[0053] Comparative Example 6 A traditional Chinese medicine composition comprising the following ingredients: 20 parts of Ophiopogon japonicus, 10 parts of Platycodon grandiflorus, 10 parts of Terminalia chebula, 6 parts of Mentha haplocalyx, 6 parts of Paeonia lactiflora, 6 parts of Glycyrrhiza uralensis, 1 part of Borneol, and 50 parts of rice wine.

[0054] The only difference between this comparative example and Example 1 is that it does not contain Scrophularia ningpoensis and the amount of Ophiopogon japonicus is increased.

[0055] Comparative Example 7 A traditional Chinese medicine composition comprising the following ingredients: 10 parts of Scrophularia ningpoensis, 10 parts of Ophiopogon japonicus, 20 parts of Platycodon grandiflorus, 6 parts of Mentha haplocalyx, 6 parts of Paeonia lactiflora, 6 parts of Glycyrrhiza uralensis, 1 part of Borneol, and 50 parts of rice wine.

[0056] The only difference between this comparative example and Example 1 is that it does not contain green fruit and the amount of Platycodon grandiflorus is increased.

[0057] Comparative Example 8 A traditional Chinese medicine composition comprising the following ingredients: 13 parts of Scrophularia ningpoensis, 13 parts of Ophiopogon japonicus, 13 parts of Platycodon grandiflorus, 13 parts of Terminalia chebula, 6 parts of Glycyrrhiza uralensis, 1 part of Borneol, and 50 parts of rice wine.

[0058] The only difference between this comparative example and Example 1 is that it does not contain peppermint or red peony root, and the amounts of scrophularia, ophiopogon, platycodon, and chebula are increased.

[0059] Endotracheal intubation is widely used in clinical practice as an important measure to maintain airway patency in patients under general anesthesia. However, the mechanical stimulation caused by this invasive procedure can easily damage the mucosal barrier of the pharynx and larynx, inducing inflammatory and stress responses in the body, thereby causing respiratory complications such as sore throat and cough.

[0060] Toll-like receptors (TLRs) are important protein molecules involved in non-specific immune responses. TLRs include various subtypes, among which TLR2 and TLR4 are considered key receptors mediating aseptic inflammation. Their core biological function is to directly or indirectly promote the synthesis and release of inflammatory factors, thereby participating in the occurrence and development of pharyngeal inflammatory damage.

[0061] Experimental study on the effects of the traditional Chinese medicine composition of this invention on endotracheal intubated rats. 1. Experimental Methods Eighty-eight SPF-grade SD rats, weighing 180-220g, were given free access to food and water. After 7 days of acclimatization, the rats were randomly divided into four groups using a random number table: a blank control group, a model group, and groups receiving treatment 1, 2, 3, 4, 5, 6, 7, 8, and 9, with eight rats in each group.

[0062] Except for the blank control group, rats in the other groups were anesthetized with 1% sodium pentobarbital to establish a tracheal intubation model. Before intubation, the skin of rats was shaved at the Tian Tu, Lian Quan, and bilateral He Gu acupoints. For groups 1-9, the herbal composition plasters of Examples 1-3 and Comparative Examples 1-6 were applied to the above acupoints and fixed with sterile dressings. The blank control group and the model group rats were treated with blank matrix plaster (Vaseline and rice wine were mixed in the same proportion as the herbal composition and rice wine in Example 1 to form a paste).

[0063] Establishment of a rat endotracheal intubation model: Anesthesia induction and endotracheal intubation: Rats were anesthetized by intraperitoneal injection of 1% sodium pentobarbital (50 mg / kg). After 3-5 minutes, the rats lost consciousness and their muscles relaxed. The anesthetized rats were fixed supine on a surgical board, tilted at approximately 45 degrees (head upwards) along with the operating table. The rat's tongue was carefully pulled out of the mouth using surgical forceps. Holding a laryngoscope in the left hand and a self-made endotracheal tube (16G vascular puncture needle) in the right, the endotracheal tube was quickly inserted into the airway the moment the glottis opened during inhalation. The position of the endotracheal tube was confirmed with a cotton swab. The ventilator was then connected and the parameters adjusted: frequency 80 breaths / min, tidal volume 5-10 ml, and inspiratory-to-expiratory ratio 1:1.5.

[0064] Anesthesia maintenance: Continuous inhalation of 1.3% isoflurane. During mechanical ventilation, observe the rat's condition, including the frequency and degree of chest rise and fall, whether the oral mucosa is red, and whether there are any abnormal movements. If any abnormalities are found, check the breathing circuit in time.

[0065] Anesthesia recovery: After 2 hours of mechanical ventilation, stop isoflurane inhalation. Once the rat is fully awake, remove the endotracheal tube and return it to the cage for dissection.

[0066] 2. Indicator Testing Throat redness and swelling score After blood collection, the rat's mouth was cut open to fully expose the palate and pharynx. Pharyngeal tissue from the base of the rat's tongue to the top of the trachea was collected, and the pharyngeal mucosa and submucosal tissue were photographed. Four scorers scored the pharyngeal redness and swelling (pharyngeal color and redness and swelling area) (0-3 points). The scoring criteria are shown in Table 1. The average value was taken, with pharyngeal color and redness and swelling area each accounting for 50% of the score, to obtain the final score.

[0067] Table 1. Grading of epigenetic indicators in rats of each group IHC detection of TLR2 and TLR4 expression levels in rat pharyngeal mucosa Pharyngeal mucosal tissue was collected, fixed, dehydrated, embedded, and sectioned. Dewaxing was performed with xylene and graded alcohols. Peroxidase was eliminated with 3% H2O2. Antigen retrieval was performed at 90℃ using 0.01M sodium citrate buffer (pH 6.0). The tissue was washed with PBS, and the antigen was blocked with 5% BSA. The blocking solution was discarded, and the tissue was incubated with primary antibody overnight at 4℃. The tissue was washed three times with PBS, incubated with secondary antibody at 37℃ for 1 hour, washed five times with PBS, incubated with SP at 37℃ for 30 minutes, washed five times with PBS, and then developed with DAB. After washing three times with PBS, hematoxylin staining was added, followed by double-distilled water blue inversion, graded alcohol dehydration, xylene clearing, and mounting with neutral resin. The slides were observed using a microscopic imaging system, and typical fields of view were selected for photographic analysis.

[0068] The grayscale values ​​were calculated using Image-Pro Plus 6.0 software, and the final average optical density (AOD) value was expressed as AOD=IOD / Area (i.e., intDen / Area).

[0069] 3. Statistical Methods Statistical analysis was performed using GraphPad Prism 8 software. All data are expressed as mean ± standard deviation. Statistical significance was determined by t-test and one-way ANOVA. P < 0.05 was considered statistically significant.

[0070] 4. Experimental Results Effects on the expression levels of TLR2 and TLR4 in the pharyngeal tissue of rats in each group Table 2. Effects on the expression levels of TLR2 and TLR4 in the pharyngeal tissue of rats in each group. Note: Compared with the blank control group, & P <0.05, && P <0.01; compared with the model group, P <0.05, P <0.01; compared with the two treated groups, # P <0.05, ## P <0.01.

[0071] Compared with the blank control group, the AOD expression of TLR2 and TLR4 in the model group rats was significantly increased, and the difference was statistically significant.

[0072] Compared with the model group, rats in treatment groups 1, 2, and 3 showed significantly reduced AOD expression in TLR2 and TLR4. Compared with treatment groups 4-9, rats in treatment groups 1, 2, and 3 showed even lower AOD expression in TLR2 and TLR4. The results are shown in Table 2.

[0073] Effects on pharyngeal redness and swelling in each group of rats Compared with the blank control group, the pharyngeal mucosa of rats in the model group was significantly red and swollen, and even yellow purulent discharge appeared.

[0074] Compared with the model group, the pharyngeal redness and swelling of rats in treatment groups 1, 2, and 3 were significantly improved, and no suppuration occurred. Compared with treatment groups 4-9, the pharyngeal redness and swelling of rats in treatment groups 1, 2, and 3 were significantly reduced. The results are shown in Table 3.

[0075] Table 3. Effects of the scores on pharyngeal redness and swelling in each group of rats. Note: Compared with the blank control group, & P <0.05, && P <0.01; compared with the model group, P <0.05, P <0.01; compared with the two treated groups, # P <0.05, ## P <0.01.

[0076] In summary, the herbal composition of this invention significantly inhibits the expression of TLR2 and TLR4 in the pharynx of a rat model of endotracheal intubation under general anesthesia, effectively alleviates pharyngeal redness and swelling, effectively improves iatrogenic pharyngeal mucosal damage after endotracheal intubation, and has a significant pharyngeal clearing effect.

[0077] The efficacy results of the traditional Chinese medicine compositions in Examples 1-3 and Comparative Examples 1-6 showed that, compared with Comparative Examples 1-6, Examples 1-3 exhibited a more significant effect in improving iatrogenic pharyngeal mucosal damage after endotracheal intubation.

[0078] The formulations of Comparative Examples 1 and 2 are different from the traditional Chinese medicine composition of the present invention. The effects of Comparative Examples 1 and 2 in improving iatrogenic pharyngeal mucosal damage after endotracheal intubation are not as good as those of the traditional Chinese medicine compositions of Examples 1-3, suggesting that the traditional Chinese medicine composition of the present invention is more effective in improving iatrogenic pharyngeal mucosal damage after endotracheal intubation.

[0079] The formulation in Comparative Example 3 did not use rice wine, and its effect on improving iatrogenic pharyngeal mucosal damage after endotracheal intubation was not as good as the traditional Chinese medicine composition in Examples 1-3.

[0080] The dosage of each raw material in the formulations of Comparative Examples 4 and 5 is different from that of the traditional Chinese medicine composition of the present invention. The effects of Comparative Examples 4 and 5 on improving iatrogenic pharyngeal mucosal damage after tracheal intubation are not as good as those of the traditional Chinese medicine composition of Example 1.

[0081] Comparative Example 6 does not contain Scrophularia ningpoensis, but increases the dosage of Ophiopogon japonicus. The effect of Comparative Example 6 in improving iatrogenic pharyngeal mucosal damage after endotracheal intubation is not as good as the Chinese medicine composition in Examples 1-3. It can be seen that the present invention emphasizes the integrity of the formulation. After reducing the Chinese medicine components, the synergistic effect of the composition is significantly weakened.

[0082] Experimental study on the improvement of ammonia-induced cough in mice by the traditional Chinese medicine composition of this invention. 1. Experimental Methods Thirty SPF-grade BALB / c mice, weighing 18-22g, were given free access to feed and water. After 7 days of acclimatization, the mice were randomly divided into a blank control group, a model group, a drug treatment group 1, a drug treatment group 10, and a drug treatment group 11, with 6 mice in each group.

[0083] The skin was shaved and prepared at the Tian Tu (CV22), Lian Quan (CV23), and bilateral He Gu (LI4) acupoints. In the treatment group 1, the herbal composition ointment from Example 1 was applied to the above acupoints and secured with sterile dressings. In treatment groups 10 and 11, the herbal composition ointments from Comparative Examples 7 and 8 were applied to the above acupoints and secured with sterile dressings, respectively. The blank control group and model group mice were treated with a blank matrix ointment (a mixture of petroleum jelly and rice wine in the same proportion as the herbal composition and rice wine in Example 1, prepared into an ointment). Treatment continued for 21 days.

[0084] One hour after administration on day 15, mice were placed in an inverted 1000 mL beaker and exposed to 0.3 mL of concentrated ammonia for 45 seconds. The mice were immediately removed, and the number of coughs within 6 minutes was observed and counted using video monitoring equipment. The number of coughs within 6 minutes on day 7 after ammonia stimulation was recorded. Under the same conditions, mice in the blank control group were exposed to 0.3 mL of physiological saline. The definition of cough in mice was an open mouth accompanied by coughing sounds, chest and abdominal muscle contractions, and anterior body twitching. This procedure was repeated for 7 consecutive days.

[0085] Statistical analysis was performed using GraphPad Prism 8 software. All data are expressed as mean ± standard deviation. Statistical significance was determined by t-test and one-way ANOVA. P < 0.05 was considered statistically significant.

[0086] Experimental results Effects on the number of coughs in each group of mice Compared with the blank control group, the number of coughs in the model group mice increased significantly within 6 minutes.

[0087] Compared with the model group, the number of coughs in the drug administration group 1 was significantly reduced within 6 minutes. Compared with drug administration groups 10 and 11, the number of coughs in the drug administration group 1 was significantly reduced within 6 minutes. Results are shown below. Figure 1 .

[0088] In summary, the herbal composition of this invention significantly reduces the number of coughs in mice with ammonia-induced cough, demonstrating a significant antitussive effect.

[0089] Comparative Example 7 did not contain Terminalia chebula, but the amount of Platycodon grandiflorus was increased. Comparative Example 8 did not contain Mentha haplocalyx or Paeonia lactiflora, but the amount of Scrophularia ningpoensis, Ophiopogon japonicus, Platycodon grandiflorus, and Terminalia chebula was increased. The antitussive effects of Comparative Examples 7 and 8 were not as good as the Chinese herbal compositions in Examples 1-3. It can be seen that the present invention emphasizes the integrity of the formulation. After reducing the Chinese herbal components, the synergistic effect of the composition is significantly weakened.

[0090] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition with the effects of clearing the throat and relieving cough, characterized in that, The traditional Chinese medicine composition contains the following components, in parts by weight: 8-12 parts of Scrophularia ningpoensis, 8-12 parts of Ophiopogon japonicus, 8-12 parts of Platycodon grandiflorus, 8-12 parts of Terminalia chebula, 4-8 parts of Mentha haplocalyx, 4-8 parts of Paeonia lactiflora, 4-8 parts of Glycyrrhiza uralensis, 0.5-1.5 parts of Borneol, and 48-55 parts of rice wine.

2. The traditional Chinese medicine composition with throat-clearing and cough-relieving effects according to claim 1, characterized in that, The traditional Chinese medicine composition contains the following components, in parts by weight: 10 parts of Scrophularia ningpoensis, 10 parts of Ophiopogon japonicus, 10 parts of Platycodon grandiflorus, 10 parts of Terminalia chebula, 6 parts of Mentha haplocalyx, 6 parts of Paeonia lactiflora, 6 parts of Glycyrrhiza uralensis, 1 part of Borneol, and 50 parts of rice wine.

3. The traditional Chinese medicine composition with throat-clearing and cough-relieving effects according to claim 1, characterized in that, The traditional Chinese medicine composition contains the following components, in parts by weight: 12 parts of Scrophularia ningpoensis, 10 parts of Ophiopogon japonicus, 8 parts of Platycodon grandiflorus, 12 parts of Terminalia chebula, 4 parts of Mentha haplocalyx, 8 parts of Paeonia lactiflora, 6 parts of Glycyrrhiza uralensis, 0.5 parts of Borneol, and 48 parts of rice wine.

4. The traditional Chinese medicine composition with throat-clearing and cough-relieving effects according to claim 1, characterized in that, The traditional Chinese medicine composition contains the following components, in parts by weight: 8 parts of Scrophularia ningpoensis, 12 parts of Ophiopogon japonicus, 10 parts of Platycodon grandiflorus, 12 parts of Terminalia chebula, 6 parts of Mentha haplocalyx, 6 parts of Paeonia lactiflora, 7 parts of Glycyrrhiza uralensis, 1 part of Borneol, and 50 parts of rice wine.

5. The use of the traditional Chinese medicine composition according to any one of claims 1-4 in the preparation of a medicine having the effect of clearing the throat and relieving cough.

6. The use of the traditional Chinese medicine composition according to any one of claims 1-4 in the preparation of a drug for improving iatrogenic pharyngeal mucosal injury after tracheal or gastric tube intubation.

7. The application according to any one of claims 5 or 6, characterized in that, The drug is a topical preparation.

8. The application according to claim 7, characterized in that, The topical preparation also includes medically acceptable pharmaceutical excipients, and the topical preparation is selected from any one of ointments, gels, liniments, films, and sprays.

9. The application according to claim 8, characterized in that, The topical preparation is an ointment.

10. A method for preparing a traditional Chinese medicine composition with throat-clearing and cough-relieving effects, characterized in that, The preparation method includes the following steps: weigh out the following ingredients according to their weight: Scrophularia, Ophiopogon japonicus, Platycodon grandiflorus, Terminalia chebula, Mentha haplocalyx, Paeonia lactiflora, Glycyrrhiza uralensis, and Borneol; pulverize them into a fine powder; add rice wine; stir and mix into a paste; and the product is ready.

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