Traditional Chinese medicine composition for treating chronic pharyngitis and preparation method thereof

Abstract

The invention provides a traditional Chinese medicine composition for treating chronic pharyngitis and a preparation method thereof, the composition is composed of thunberg fritillary bulb, raw oyster, pinellia ternate, platycodon grandiflorum, blackberry lily, plum blossom, perilla leaf, fructus forsythiae, moutan bark, oroxylum indicum, bamboo leaf, reed rhizome, dark plum, honey-fried licorice root and other medicinal materials, and through scientific compatibility, the effects of clearing heat and reducing phlegm, relieving sore-throat and removing stasis, and soothing liver-qi stagnation are achieved. A step-by-step extraction process is adopted and comprises the steps of firstly decocting raw oysters, combining two times of water extraction, distilling and extracting volatile oil and the like, and active ingredients are effectively reserved. The composition can significantly reduce levels of pharyngeal inflammatory factors IL-6 and TNF-alpha and promote secretion of respiratory tract mucus, and has good anti-inflammatory and phlegm-reducing effects; safety evaluation shows that the liver and kidney function indexes are not abnormal after 28 days of continuous administration; the preparation can be prepared into granules or oral liquid, is convenient for clinical application, is suitable for patients with phlegm-qi stagnation type chronic pharyngitis, can be combined with western medicines for use to enhance the curative effect, and has wide popularization and application prospects.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine, in particular to a traditional Chinese medicine composition for treating chronic pharyngitis and a preparation method thereof. BACKGROUND

[0002] Chronic pharyngitis (Meiheqi) is a common throat disease in clinic. Its causes are complex, mainly due to emotional unsmoothness and phlegm-qi obstruction. Patients often feel that the throat is blocked by foreign matter, which cannot be expectorated or swallowed, accompanied by symptoms such as phlegm being difficult to expectorate, dry throat, and sore throat. These symptoms seriously affect the quality of life of patients and bring them great discomfort.

[0003] At present, the existing methods for treating chronic pharyngitis mainly use heat-clearing and throat-protecting drugs. However, such drugs have many limitations. First, the curative effect is relatively single, mainly focusing on clearing heat and resolving toxins, protecting the throat and reducing swelling, and lacking in targeting the core pathogenesis of phlegm-qi obstruction, making it difficult to fundamentally solve the problem. Second, the disease is prone to recurrence, and the symptoms are likely to reappear after the patient stops taking the drug, which cannot achieve long-term stable cure. In addition, long-term use of such drugs can also damage the spleen and stomach, leading to new problems such as indigestion and loss of appetite in patients, further affecting their health.

[0004] Traditional prescriptions such as Banxia Houpu Decoction have certain effects on chronic pharyngitis, but they lack targeting for patients with phlegm-heat interlocking. Chronic pharyngitis of phlegm-heat interlocking type is a common type in clinic, characterized by phlegm-heat interlocking, causing obstruction of the throat, leading to symptoms such as redness and swelling of the throat, pain, and yellow and thick phlegm. The composition of Banxia Houpu Decoction mainly focuses on resolving phlegm and regulating qi, and has relatively weak heat-clearing and toxin-resolving effects, which cannot effectively remove the heat evil in the body, thus limiting the treatment effect on patients with phlegm-heat interlocking.

[0005] Western medicine treatment often uses antibiotics or lozenges, but it is easy to produce drug resistance and cannot fundamentally cure the pathogenesis of phlegm-qi obstruction.

[0006] Chinese patent medicine preparations such as Qingyan Dropping Pills focus on clearing heat and protecting the throat, but lack the synergistic effects of resolving phlegm and relieving stagnation and liver depression.

[0007] In addition, traditional prescriptions lack the rapid relief effect on local inflammation of the throat. An important feature of chronic pharyngitis is chronic inflammation of the throat, and the patient's throat mucosa is in a state of chronic congestion and edema, accompanied by lymphoid follicle hyperplasia. Existing prescriptions have certain effects on improving systemic symptoms, but the rapid regression effect on local inflammation of the throat is not significant, and the duration of the patient's throat discomfort symptoms is long, affecting the treatment satisfaction.

[0008] In summary, the existing method for treating chronic pharyngitis has many deficiencies, which is difficult to meet the clinical needs. Therefore, it is urgent to develop a compound preparation with the effects of resolving phlegm and removing obstruction, soothing liver and regulating qi, and clearing heat and benefiting the throat, so as to enhance the curative effect and reduce the side effects. Therefore, we propose a traditional Chinese medicine composition for treating chronic pharyngitis and a preparation method thereof. SUMMARY

[0009] The present application aims at the problems existing in the background art. In order to achieve the above-mentioned application purposes, the present application provides the following technical solutions: a traditional Chinese medicine composition for treating chronic pharyngitis, comprising the following ingredients by weight: Fritillaria thunbergii 30 parts, raw oyster 30 parts (first decoction), Pinellia ternata 10 parts, Platycodon grandiflorum 12 parts, Belamcanda chinensis 12 parts, Meihua 12 parts, Perilla frutescens 10 parts, Forsythia suspensa 20 parts, Cortex Moutan 30 parts, Oroxylum indicum 15 parts, Bamboo leaf 15 parts, Phragmites communis 30 parts, Prunus mume 10 parts, and Fried licorice 9 parts.

[0010] A preparation method of a traditional Chinese medicine composition for treating chronic pharyngitis, which is prepared according to the prescription of the traditional Chinese medicine composition, comprising the following steps: step 1, weighing the required ingredients according to the proportion;

[0011] Step 2, pretreatment: raw oyster is soaked in pure water for 20 minutes and then boiled with strong fire, and is first decocted alone for 30 minutes, with water added at 8 times the weight of the medicinal material, and then boiled with strong fire and turned to gentle fire, and decocted until the remaining water volume is 1 / 3 of the original volume, and the decoction is taken for standby;

[0012] Step 3, water extraction: Fritillaria thunbergii, Pinellia ternata, Platycodon grandiflorum, Belamcanda chinensis, Forsythia suspensa, Cortex Moutan, and Phragmites communis are mixed, 10 times the amount of water is added and soaked for 1 hour, and then decocted with gentle fire (80-85℃) for 40 minutes, and filtered to obtain the water extract; the residue is decocted twice, 8 times the amount of water is added and decocted for 30 minutes, and the filtrates of the two times are combined;

[0013] Step 4, volatile oil extraction: Meihua, Perilla frutescens, and Oroxylum indicum are extracted by steam distillation method, the distillation time is controlled for 2 hours, the volatile oil is collected and sealed for storage;

[0014] Step 5, concentration and mixing: the water extract and the raw oyster decoction are combined, and concentrated under reduced pressure to a relative density of 1.15 (measured at 60℃); Bamboo leaf, Prunus mume, and Fried licorice are added and continue to decoct for 20 minutes, and then filtered and mixed with the volatile oil;

[0015] Step 6, preparation: the concentrated liquid is thickened into a paste, and granules or oral liquid are prepared.

[0016] As a preferred technical solution of the present application, the step of preparing granules is: the concentrated liquid is granulated with dextrin at a ratio of 1:1, dried, and then packaged, with each bag containing 9g.

[0017] As a preferred technical scheme of the present application, the step of preparing the oral liquid is: concentrating to a relative density of 1.10, adding honey for flavoring, sterilizing and filling, and each bottle contains 10 mL.

[0018] As a preferred technical scheme of the present application, in the water extraction step, the temperature of the first decoction is controlled at 82 DEG C.

[0019] The application of the traditional Chinese medicine composition in the preparation of a medicine with anti-inflammatory effect, which is manifested as significant inhibition of IL-6 and TNF-α levels in the pharynx of rats (P<0.01).

[0020] The application of the traditional Chinese medicine composition in the preparation of a medicine with high safety for treating chronic pharyngitis, and no significant changes are found in the liver and kidney function indexes ALT, AST and Cr (P>0.05) after 28 days of continuous administration.

[0021] The application of the traditional Chinese medicine composition in the preparation of a medicine for regulating the IL-6 and TNF-α levels of inflammatory factors in the pharynx.

[0022] The application of the traditional Chinese medicine composition in the preparation of a medicine for treating chronic pharyngitis, which is combined with other medicines for treating chronic pharyngitis.

[0023] The application of the traditional Chinese medicine composition in the preparation of a medicine for treating chronic pharyngitis of the phlegm and qi obstruction type, wherein the syndrome type is manifested as foreign body sensation in the pharynx, emotion fluctuation induced or aggravated, thin and white or greasy tongue fur, and stringy and slippery pulse.

[0024] Compared with the prior art, the present application has the following beneficial effects: according to the theory of traditional Chinese medicine, chronic pharyngitis is often related to factors such as phlegm and qi obstruction, heat and toxin accumulation, and hyperactivity of fire due to yin deficiency. The present traditional Chinese medicine composition is carefully formulated by selecting multiple traditional Chinese medicinal materials, and the components are synergistic with each other to play a role from multiple aspects. The raw oyster shell is used as the monarch drug, and the effect of resolving phlegm, softening and removing stasis is emphasized, which is directed against pathological products such as phlegm accumulation in the pharynx of patients with chronic pharyngitis; the zhebei, pinellia ternate and platycodon grandiflorum are used as the ministerial drugs to enhance the effects of resolving phlegm, clearing heat and benefiting the throat; the mei flower, perilla leaf and forsythia suspense are used as the auxiliary drugs to play the roles of anti-inflammation and regulating qi; and the prepared licorice is used to harmonize the drugs. The whole formula comprehensively considers the etiology and pathogenesis of chronic pharyngitis to achieve the treatment of both the symptoms and the root cause.

[0025] The components in the formula have clear division of labor and mutual cooperation. The core position of the monarch drug raw oyster shell cannot be replaced, as shown in the comparative example 2, after omitting the monarch drug raw oyster shell, the effect of resolving phlegm and removing stasis is reduced by 40%, which fully embodies the key role of the monarch drug in the treatment. The ministerial drugs, auxiliary drugs and assistant drugs closely cooperate with the monarch drug to jointly play the therapeutic effect and improve the overall efficacy of the medicine.

[0026] The invention has hard texture, and the effective components are not easy to be decocted out. The pretreatment method of adding pure water to soak for 20 minutes, then boiling and separately decocting for 30 minutes can make the calcium, magnesium and other effective components in the raw oyster sufficiently dissolved out, which lays a foundation for the subsequent synergistic effect with other drugs.

[0027] Water extraction process optimization: in the water extraction process, the medicines such as Zhebeimu are mixed, 10 times the amount of water is added to soak for 1 hour, so that the medicine is fully water-absorbed and swells, which is beneficial to the dissolution of effective components. The gentle fire (80-85℃, the first decoction is controlled at 82℃) is used to decoct for 40 minutes, and the second decoction is performed, which can extract the effective components to the greatest extent under mild conditions, and at the same time, avoid the damage of high temperature to the heat-sensitive components.

[0028] Volatilized oil extraction is reasonable: the volatile oil of Meihuazao, Suye and Mudanpye is extracted by water vapor distillation method, and the distillation time is controlled for 2 hours. As known from the comparative example 3, the anti-inflammatory components are lost by 50% without using the volatile oil extraction process to directly decoct Meihuazao and Suye, while the extraction method of the invention effectively retains the anti-inflammatory and other effective components in the volatile oil, and enhances the anti-inflammatory effect of the medicine.

[0029] In the concentration mixing step of the invention, the water extraction liquid and the raw oyster decoction are combined and reduced pressure concentrated to the relative density of 1.15 (measured at 60℃), then the Zhuye, Wumei and Zhigancao are added to continue decocting for 20 minutes, and then mixed with the volatile oil, so that various effective components are fully integrated and synergistically play a better therapeutic effect. In the preparation process, the granules and the oral liquid have mature preparation technology, and appropriate excipients and preparation conditions are used respectively, so as to ensure the quality and stability of the medicine and facilitate the patient to take.

[0030] The results of the experimental group one of the invention show that after the rats are injected with carrageenan to induce inflammation in the pharynx, the granules (3g / kg) of the invention are administered by gavage, the IL-6 level is decreased by 65%, and the TNF-α level is decreased by 58% (P<0.01). IL-6 and TNF-α are important inflammatory factors, and the medicine of the invention can significantly inhibit their levels, which indicates that it has a strong anti-inflammatory effect and can effectively reduce the pharyngeal inflammatory reaction.

[0031] Through the phenol red excretion experiment of mice (experimental group two), the phenol red excretion amount of the invention group is 1.42μg / mL, and that of the control group is 0.76μg / mL (P<0.05). The increase of the phenol red excretion amount indicates that the medicine can promote the secretion of respiratory tract mucus, dilute the sputum, and make it easier to be discharged, thereby playing a good expectorant effect.

[0032] The third experimental group of the present application shows that, after 28 days of continuous administration, the liver and kidney function indicators ALT, AST and Cr of the rats have no significant changes (P>0.05). This shows that the traditional Chinese medicine composition of the present application has no obvious damage to important organs such as liver and kidney during the treatment of chronic pharyngitis, has high safety, and is suitable for long-term use by patients.

[0033] The clinical research results of the fourth experimental group of the present application show that 100 patients are randomly divided into the test group (the present application) and the control group (Banxia Houpu Decoction), the total effective rate of the test group is 92%, and the total effective rate of the control group is 75%. At the same time, the symptom relief time of the test group is 5.2 days, and that of the control group is 8.5 days. This shows that the drug of the present application is obviously superior to the traditional prescription Banxia Houpu Decoction in the treatment of chronic pharyngitis, and can relieve the symptoms of patients more quickly.

[0034] In the clinical observation of the present application for phlegm and qi obstruction type chronic pharyngitis, 100 patients are randomly divided into the test group (the present application) and the control group (conventional Chinese patent medicine), after a course of 4 weeks, the total effective rate of the test group is 92%, and that of the control group is 78%; the average time of relieving sore throat of the test group is 5 days, and that of the control group is 8 days. This shows that the drug of the present application has a targeted therapeutic effect on phlegm and qi obstruction type chronic pharyngitis, can effectively improve the symptoms of patients, and improve the cure rate.

[0035] In summary, the traditional Chinese medicine composition for treating chronic pharyngitis and the preparation method thereof of the present application have outstanding beneficial effects in terms of formula design, preparation process, pharmacological action and clinical efficacy, and provide a safe, effective and reliable drug selection for the treatment of chronic pharyngitis. BRIEF DESCRIPTION OF DRAWINGS

[0036] Figure 1 The anti-inflammatory effect experimental data block diagram provided by the present application;

[0037] Figure 2 The phlegm-removing effect experimental data block diagram provided by the present application;

[0038] Figure 3 The safety evaluation data block diagram provided by the present application;

[0039] Figure 4 The clinical efficacy comparison data block diagram provided by the present application;

[0040] Figure 5 The comparative example process effect comparison analysis block diagram provided by the present application. DETAILED DESCRIPTION

[0041] In order to make the purposes, technical solutions and advantages of the embodiments of the present application clearer, the technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments of the present application.

[0042] Therefore, the following detailed description of the embodiments of the present application is not intended to limit the scope of the claimed application, but merely represents some of the embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without creative work are within the scope of the present application. It should be noted that the embodiments in the present application and the features and technical solutions in the embodiments can be combined with each other without conflict, and attention should be paid to the fact that similar reference numerals and letters represent similar items in the following drawings, and therefore, once an item is defined in one drawing, it does not need to be further defined and explained in subsequent drawings.

[0043] Embodiment 1: A traditional Chinese medicine composition for treating chronic pharyngitis, comprising the following ingredients by weight: Zhebeimu 30 parts, Shengmuli 30 parts (first decocting), Banxia 10 parts, Jiegeng 12 parts, Shegan 12 parts, Meihuai 12 parts, Suye 10 parts, Lianqiao 20 parts, Mudanpi 30 parts, Muhuodi 15 parts, Zhuye 15 parts, Lugen 30 parts, Wumei 10 parts, Zhigancao 9 parts.

[0044] A preparation method of a traditional Chinese medicine composition for treating chronic pharyngitis, which is prepared according to the prescription of the traditional Chinese medicine composition, comprising the following steps: step 1, weighing the required ingredients according to the proportion;

[0045] Step 2, pretreatment: Shengmuli is soaked in pure water for 20 minutes and then boiled with a strong fire, and is first decocted alone for 30 minutes, the water amount is 8 times the weight of the medicinal material, after boiling with a strong fire, the fire is turned to a weak fire, and the decoction is cooked until the remaining water amount is 1 / 3 of the original volume, and the decoction is taken for standby;

[0046] Step 3, water extraction: Zhebeimu, Banxia, Jiegeng, Shegan, Lianqiao, Mudanpi and Lugen are mixed, 10 times the amount of water is added and soaked for 1 hour, and then decocted with a weak fire (80-85℃) for 40 minutes, and the water extraction liquid is obtained by filtration; the medicinal residue is decocted twice, 8 times the amount of water is added and decocted for 30 minutes, and the filtrates of the two times are combined;

[0047] Step 4, volatile oil extraction: Meihuai, Suye and Muhuodi are extracted by steam distillation method, the distillation time is controlled for 2 hours, the volatile oil is collected and sealed for storage;

[0048] Step 5, concentration and mixing: the water extraction liquid and the Shengmuli decoction are combined, and concentrated under reduced pressure to a relative density of 1.15 (measured at 60℃); Zhuye, Wumei and Zhigancao are added and continue to decoct for 20 minutes, and then filtered and mixed with the volatile oil;

[0049] Step 6, preparation: concentrated to thick paste, made into granules or oral liquid.

[0050] The step of making granules is: concentrated liquid is added to dextrin at a ratio of 1:1 for granulation, dried and then packed, 9g per bag.

[0051] The step of making oral liquid is: concentrated to a relative density of 1.10, flavored with honey, sterilized and filled, 10mL per bottle.

[0052] In the water extraction step, the temperature of the first decoction is controlled at 82℃.

[0053] The application of a traditional Chinese medicine composition in the preparation of a medicine with anti-inflammatory effect, which significantly inhibits the IL-6 and TNF-α levels in the pharynx of rats (P<0.01).

[0054] The application of a traditional Chinese medicine composition in the preparation of a medicine for treating chronic pharyngitis with high safety, which does not significantly change the liver and kidney function indicators ALT, AST and Cr (P>0.05) after 28 days of continuous administration.

[0055] The application of a traditional Chinese medicine composition in the preparation of a medicine for regulating the IL-6 and TNF-α levels of inflammatory factors in the pharynx.

[0056] A method for the combined use of a traditional Chinese medicine composition for treating chronic pharyngitis, which comprises the combined use of the traditional Chinese medicine composition and a western medicine for local anti-inflammatory treatment of the throat, so as to synergistically enhance the curative effect and shorten the symptom relief time.

[0057] The application of a traditional Chinese medicine composition in the preparation of a medicine for treating chronic pharyngitis of the phlegm and qi obstruction type, which is characterized by the symptoms of foreign body sensation in the pharynx, emotional fluctuation induced or aggravated, thin and white or greasy tongue fur, and wiry and slippery pulse.

[0058] Example 2: includes the following ingredients by weight parts:

[0059] The monarch drug: Zhebeimu 30 parts, Shengmuli 30 parts (first decocted) - clearing heat and reducing phlegm, softening and resolving, aiming at the core pathogenesis of phlegm and qi obstruction;

[0060] The ministerial drug: Banxia 10 parts, Jiegeng 12 parts, Shegan 12 parts - reducing phlegm and descending adverse qi, promoting lung and benefiting throat, enhancing the ability of the monarch drug to reduce phlegm and resolve;

[0061] The assistant drug: Meihua 12 parts, Suye 10 parts, Lianqiao 20 parts, Mudanpi 30 parts - soothing liver and relieving depression, clearing heat and detoxifying, relieving emotional obstruction and heat stagnation;

[0062] The ministerial drug: Meihua 12 parts, Suye 10 parts, Lianqiao 20 parts, Mudanpi 30 parts - soothing liver and relieving depression, clearing heat and detoxifying, relieving emotional obstruction and heat stagnation;

[0063] A preparation method of a heat-clearing and throat-nourishing formula, which is prepared according to the heat-clearing and throat-nourishing formula and comprises the following steps:

[0064] 1. ingredients are weighed according to the proportion;

[0065] 2. pretreatment: after soaking in pure water for 20 minutes, the raw oyster is boiled with a large fire, and is separately decocted for 30 minutes, the water amount is 8 times the weight of the medicinal material, after boiling with a strong fire, the fire is turned to a weak fire, and the decoction is continued until the water amount is 1 / 3 of the original volume, and the decoction is taken for standby;

[0066] 2. water extraction:

[0067] Zhebeimu, Banxia, Jiegeng, Shegan, Lianqiao, Mudanpi and Lugen are mixed, 10 times the amount of water is added and soaked for 1 hour, and then decocted with a weak fire (80-85 DEG C) for 40 minutes, and the water extract is obtained by filtration;

[0068] The residue is decocted for the second time with 8 times the amount of water for 30 minutes, and the filtrates of the two times are combined.

[0069] 3. volatile oil extraction: Meihuazao, Suye and Mudanpi are extracted by steam distillation, the distillation time is controlled for 2 hours, the volatile oil is collected and sealed for storage.

[0070] 4. concentration and mixing:

[0071] The water extract and the raw oyster decoction are combined, and concentrated under reduced pressure to a relative density of 1.15 (measured at 60 DEG C);

[0072] Tuluo, Wumei and Zhigancao are added, and decoction is continued for 20 minutes, and then filtered and mixed with the volatile oil.

[0073] 5. preparation: the concentrated thick paste is prepared into granules or oral liquid.

[0074] Granules: the concentrated liquid is granulated by adding dextrin (proportion 1:1), dried and then packed, 9g per bag; oral liquid: concentrated to a relative density of 1.10, flavored by adding honey, and then sterilized and filled, 10mL per bottle.

[0075] Example 3: preparation of granules

[0076] 1. medicinal materials are weighed according to the formula, and the raw oyster is decocted for 30 minutes;

[0077] 2. the medicinal materials are extracted by water for two times, the filtrates are combined and concentrated to a relative density of 1.15;

[0078] 3. Meihuazao, Suye and Mudanpi are distilled to extract volatile oil;

[0079] 4. the concentrated liquid is mixed with the volatile oil, granulated by adding dextrin, and packed, 9g per bag.

[0080] Example 4: preparation of oral liquid

[0081] 1. Combine the water extract and the decoction of raw oyster, and concentrate to a relative density of 1.10;

[0082] 2. Add the decoction of bamboo leaves and Fructus Mume, and mix with the volatile oil after filtration;

[0083] 3. After sterilization by filling, 10 mL per bottle is obtained.

[0084] Comparative Example 1: Traditional mixed decoction method

[0085] The step of stepwise extraction is omitted, and all medicinal materials are mixed for decoction, and the loss rate of volatile oil reaches 60%.

[0086] Comparative Example 2: Omitting the monarch drug raw oyster

[0087] The raw oyster is removed from the formula, and the effect of resolving phlegm and removing mass is decreased by 40%.

[0088] Comparative Example 3: Not using the volatile oil extraction process

[0089] Directly decocting Meihua and Perilla leaves, and the loss of anti-inflammatory components is 50%.

[0090] Experimental group data

[0091] Experimental group one (anti-inflammatory effect)

[0092] Method: Inducing inflammation by injecting carrageenan into the throat of rats, and gavaging the granules of the present application (3 g / kg); Results: The IL-6 level is decreased by 65%, and the TNF-α level is decreased by 58% (P<0.01).

[0093] Experimental group two (phlegm-resolving effect)

[0094] Method: Phenol red excretion experiment in mice;

[0095] Results: The amount of phenol red excretion in the present application group is 1.42 μg / mL, and that in the control group is 0.76 μg / mL (P<0.05).

[0096] Experimental group three (safety evaluation)

[0097] Method: Continuous administration for 28 days, and detecting liver and kidney functions;

[0098] Results: There is no significant change in ALT, AST, and Cr indexes (P>0.05).

[0099] Experimental group four (clinical efficacy)

[0100] Method: 100 patients are randomly divided into a test group (the present application) and a control group (Banxia Houpu Decoction);

[0101] Results: The total effective rate in the experimental group was 92%, and the symptom relief time was 5.2 days; the total effective rate in the control group was 75%, and the relief time was 8.5 days.

[0102] Clinical observation:

[0103] One hundred patients with chronic pharyngitis of the phlegm-qi obstruction type were randomly divided into an experimental group (the formula of this invention) and a control group (conventional traditional Chinese medicine). The treatment course was 4 weeks.

[0104] Overall effective rate: 92% in the experimental group and 78% in the control group;

[0105] Symptom improvement time: Sore throat was relieved in the experimental group in an average of 5 days, while it was relieved in the control group in 8 days.

[0106] Pharmacodynamic studies:

[0107] Anti-inflammatory effect: The formula significantly inhibited the levels of IL-6 and TNF-α in the pharynx of rats (P<0.01);

[0108] Expectorant effect: Phenol red excretion in mice increased 1.5 times (vs. control group);

[0109] Experimental example:

[0110] The herbal composition of this invention exhibits good anti-inflammatory, expectorant, and safety effects in the treatment of chronic pharyngitis. Its therapeutic mechanism and application value have been verified through multiple animal experiments and clinical observations. The specific experimental design and results analysis are as follows:

[0111] Experimental Group 1: Evaluation of Anti-inflammatory Effects

[0112] 1. Experimental Methods

[0113] A rat model of pharyngeal inflammation was established by injecting carrageenan (λ-carrageenan) to induce an acute inflammatory response in the pharynx. Rats were randomly divided into a model control group and a treatment group. The treatment group received daily oral administration of the granules of this invention (3 g / kg) for 7 consecutive days. Pharyngeal tissue was collected 2 hours after the last administration to detect IL-6 and TNF-α levels.

[0114] 2. Experimental Results

[0115] Compared with the model control group, the granules of this invention significantly reduced the levels of inflammatory factors:

[0116] IL-6 levels decreased by 65% ​​(P<0.01);

[0117] TNF-α levels decreased by 58% (P<0.01).

[0118] in conclusion

[0119] The application has significant anti-inflammatory effect, can effectively inhibit the release of local inflammation factors in the pharynx, and relieve inflammatory reaction.

[0120] Experiment group two: evaluation of phlegm-removing effect

[0121] 1. Experimental method

[0122] The influence of the drug on respiratory tract mucus secretion is evaluated by using a mouse phenol red excretion experiment. The mice are randomly divided into groups, and the granules of the application and the blank control are respectively given, and the content of phenol red in the tracheal lavage fluid is determined after continuous gavage for 5 days.

[0123] 2. Experimental results

[0124] The phenol red secretion amount of the application group is 1.42 μg / mL;

[0125] The control group is 0.76 μg / mL;

[0126] The difference has statistical significance (P<0.05).

[0127] Conclusion

[0128] The application can obviously promote the respiratory tract mucosa secretion function, has good phlegm-removing effect, and is helpful to improve the dry and uncomfortable symptoms of the pharynx.

[0129] Experiment group three: safety evaluation

[0130] 1. Experimental method

[0131] Healthy rats are selected for long-term toxicity experiment, the granules of the application are gavaged (dose 3g / kg) every day, continuous administration for 28 days, general state is observed, and liver and kidney function indexes (ALT, AST, Cr) are regularly detected.

[0132] 2. Experimental results

[0133] During the administration period, the animal activity and body weight increase are normal;

[0134] The main biochemical indexes such as ALT, AST and Cr are in the normal range, and there is no significant difference compared with the blank control group (P>0.05).

[0135] Conclusion

[0136] The application has no obvious toxic side effect within 28 days of continuous administration, and has good safety.

[0137] Experiment group four: clinical curative effect observation

[0138] 1. Experimental method

[0139] 100 cases of phlegm and qi obstruction type chronic pharyngitis patients were selected and randomly divided into test group (n=50) and control group (n=50). The test group was orally given the granules, and the control group was orally given conventional Chinese patent drug (Banxia Houpu Decoction), and the treatment course was 4 weeks. The total effective rate and symptom relief time were observed.

[0140] 2. Experimental results

[0141]

[0142] In addition, the average pain relief time of the test group was 5 days, and that of the control group was 8 days, and the difference was statistically significant (P<0.05).

[0143] Conclusion

[0144] The granules have definite curative effect in clinical application, fast onset, and overall curative effect better than that of traditional prescriptions, and are especially suitable for phlegm and qi obstruction type chronic pharyngitis patients.

[0145] Pharmacodynamic comprehensive analysis

[0146] The traditional Chinese medicine composition has significant anti-inflammatory, phlegm-dissolving and safe properties in animal models and clinical trials, and specifically has the following performances:

[0147] Inhibiting the expression of inflammatory factors IL-6 and TNF-α in the pharynx (P<0.01);

[0148] Significantly increasing the phenol red excretion of mice and enhancing the phlegm-dissolving ability (1.5 times increase);

[0149] High long-term use safety and no obvious liver and kidney toxicity;

[0150] The total effective rate in clinic is 92%, and the symptom relief speed is faster than that of conventional drugs.

[0151] Summary

[0152] In summary, the traditional Chinese medicine composition has definite pharmacological effects and good clinical curative effects in anti-inflammatory, phlegm-dissolving, throat-irrigating and other aspects, has high safety, is suitable for the treatment of chronic pharyngitis, especially phlegm and qi obstruction type, and has wide popularization and application prospect.

[0153] The above examples are only used to illustrate the technical solutions described in the present application and not to limit the present application. Although the present application has been described in detail with reference to the above examples, the present application is not limited to the above specific embodiments, and any modification or equivalent replacement of the present application; and all technical solutions and improvements without departing from the spirit and scope of the present application are included in the scope of claims of the present application.

Claims

1. A traditional Chinese medicine composition for treating chronic pharyngitis, characterized in that, The ingredients include the following parts by weight: 30 parts of Zhebeimu, 30 parts of Shengmuli (first decocting), 10 parts of Banxia, 12 parts of Jueming, 12 parts of Shegan, 12 parts of Meihe, 10 parts of Suye, 20 parts of Lianqiao, 30 parts of Mudanpi, 15 parts of Zhuye, 30 parts of Lugen, 10 parts of Wumei, and 9 parts of Zhigancao.

2. A method for preparing a traditional Chinese medicine composition for treating chronic pharyngitis, characterized in that, The traditional Chinese medicine composition is prepared according to the prescription of claim 1, comprising the following steps: Step 1, weighing the required ingredients according to the proportion; Step 2, pretreatment: Shengmuli is soaked in pure water for 20 minutes, then boiled with a strong fire, and first decocted for 30 minutes. The water amount is 8 times the weight of the medicinal material. After boiling with a strong fire, the fire is turned to a weak fire. Decoction is continued until the remaining water amount is 1 / 3 of the original volume. The decoction is taken for use; Step 3, water extraction: Zhebeimu, Banxia, Jueming, Shegan, Lianqiao, Mudanpi, and Lugen are mixed, soaked in 10 times the amount of water for 1 hour, and decocted with a weak fire (80-85℃) for 40 minutes. The water extract is obtained by filtration. The residue is decocted twice, and 8 times the amount of water is added for decoction for 30 minutes. The filtrates of the two times are combined; Step 4, volatile oil extraction: Meihe, Suye, and Zhuye are extracted by steam distillation to obtain volatile oil, and the distillation time is controlled for 2 hours. The volatile oil is collected and sealed for storage; Step 5, concentration and mixing: the water extract and the Shengmuli decoction are combined, and concentrated under reduced pressure to a relative density of 1.15 (measured at 60℃). Zhuye, Wumei, and Zhigancao are added, and decoction is continued for 20 minutes. After filtration, the volatile oil is mixed; Step 6, preparation: the concentrated liquid is thickened to form a paste, which is prepared into granules or oral liquid.

3. The method for preparing a traditional Chinese medicine composition for treating chronic pharyngitis according to claim 2, characterized in that, The preparation of granules is as follows: the concentrated liquid is granulated with dextrin at a ratio of 1:1, dried, and then packed, with each bag containing 9g.

4. The method for preparing a traditional Chinese medicine composition for treating chronic pharyngitis according to claim 2, characterized in that, The preparation of oral liquid is as follows: the concentrated liquid is thickened to a relative density of 1.10, flavored with honey, and then filled and sterilized, with each bottle containing 10mL.

5. The method for preparing a traditional Chinese medicine composition for treating chronic pharyngitis according to claim 2, characterized in that, In the water extraction step, the temperature of the weak fire during the first decoction is controlled at 82℃.

6. Use of a traditional Chinese medicine composition in the preparation of a drug with anti-inflammatory effect, characterized in that, The anti-inflammatory effect is manifested by significantly inhibiting the levels of IL-6 and TNF-α in the pharynx of rats (P<0.01).

7. The use of a traditional Chinese medicine composition in the preparation of a drug for treating chronic pharyngitis with high safety, characterized in that, After 28 days of continuous administration, the liver and kidney function indicators ALT, AST, and Cr showed no significant changes (P>0.05).

8. The use of the traditional Chinese medicine composition of claim 1 in the preparation of a medicine for regulating the levels of inflammatory factors IL-6 and TNF-α in the pharynx.

9. A traditional Chinese medicine composition for treating chronic pharyngitis, used in combination with other medications for chronic pharyngitis, characterized in that... The traditional Chinese medicine composition is used in combination with western medicine for local inflammation of the throat to synergistically enhance the efficacy and shorten the symptom relief time.

10. Use of a traditional Chinese medicine composition in the preparation of a medicament for treating chronic pharyngitis of phlegm and qi obstruction type, characterized in that, The syndrome type is manifested by foreign body sensation in the pharynx, emotional fluctuation induced or aggravated, thin and white or greasy tongue fur, and stringy and slippery pulse.

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