Traditional Chinese medicine composition for improving dysphagia as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition for improving dysphagia as well as a preparation method and application thereof, and relates to the technical field of traditional Chinese medicine, the traditional Chinese medicine composition for improving dysphagia comprises the following components in parts by weight: 28-35 parts of penthorum chinense pursh, 15-24 parts of angelica citriodora, 10-18 parts of radix ophiopogonis, 5-10 parts of radix scrophulariae, 8-15 parts of rhizoma acori graminei, 5-10 parts of cinnamon and 3-6 parts of liquorice. Penthorum chinense pursh and cynanchum auriculatum are taken as monarch drugs, and radix ophiopogonis, radix scrophulariae and rhizoma acori graminei are taken as ministerial drugs, so that the efficacy of the monarch drugs The cinnamon is used as an adjuvant to warm and dredge meridians and promote qi-blood circulation; and the liquorice is used as a conductant drug to harmonize the medicines. Animal experiments show that the traditional Chinese medicine composition provided by the invention can significantly improve the swallowing function of a tMCAO rat model, provides a new treatment means for dysphagia diseases, and has very important significance for improving the life quality of patients suffering from dysphagia and the like caused by diseases such as cerebral apoplexy and the like.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for improving dysphagia, a preparation method thereof, and an application thereof. Background Art

[0002] Dysphagia is a common clinical symptom, mainly manifested as the patient being unable to safely and effectively send food from the mouth into the stomach due to damage to the structures and functions of organs such as the mandible, lips, tongue, soft palate, pharynx, and esophagus. This symptom is particularly common in stroke patients, and nearly half of stroke patients are deeply troubled by it. Dysphagia not only affects the patient's normal diet but also is often accompanied by a series of complications such as aspiration pneumonia, malnutrition, and dehydration, which have a serious impact on the physical and mental health and quality of life of the patient, and even increase the mortality rate.

[0003] In the field of Western medicine, there are various means for treating dysphagia, mainly including rehabilitation training, electrical stimulation, magnetic stimulation, etc. Rehabilitation training aims to enhance the swallowing muscle strength and coordination of the patient through a series of specific oral, pharyngeal, and laryngeal movement trainings, thereby improving the swallowing function. Electrical stimulation and magnetic stimulation use electric current or magnetic field to stimulate the swallowing-related nerves and muscles to promote the recovery of nerve function and muscle contraction. These methods have indeed improved the swallowing function of patients to a certain extent, but there are also many limitations. Rehabilitation training requires long-term adherence, and the treatment effect varies from person to person; electrical stimulation and magnetic stimulation may require professional equipment and operation techniques, and some patients may not be able to tolerate them or have adverse reactions. More critically, for patients with post-stroke neurological dysphagia, Western medicine currently lacks specific targeted drugs, and the treatment mainly focuses on symptomatic support, and it is impossible to fundamentally solve the pathological essence such as phlegm stasis blocking collaterals, resulting in the difficult effective recovery of the patient's swallowing function.

[0004] Compared with Western medicine treatment methods, traditional Chinese medicine treatment of dysphagia has its unique advantages. Traditional Chinese medicine pays attention to the overall concept and syndrome differentiation and treatment. It is believed that although there is no clear disease name for dysphagia, according to its related symptoms, it can be classified into the categories of "diaphragm middle", "dysphagia", "laryngeal obstruction", "aphonia with flaccidity", etc. Its pathogenesis is mainly characterized by the unfavorable yin-yang pivot of the throat, phlegm stasis mutual binding, and abnormal ascending and descending. The treatment principle should be to open orifices and relieve sore throat, promote qi and activate blood circulation to resolve phlegm. There are various treatment methods for dysphagia recorded in ancient medical books, such as using the legislation of opening orifices and relieving sore throat, promoting blood circulation and resolving phlegm, and making pharyngeal drops for oral and pharyngeal administration, etc., which all reflect the unique ideas and rich experience of traditional Chinese medicine in the treatment of dysphagia.

[0005] In view of the severity and treatment needs of dysphagia, especially post-stroke dysphagia, and the limitations of Western medicine treatment methods, it has become an urgent problem to be solved to prepare an effective traditional Chinese medicine composition using the theory of traditional Chinese medicine to improve the symptoms of dysphagia patients. Summary of the Invention

[0006] In order to solve the above problems, the present invention provides a Chinese medicine composition for improving dysphagia, and a preparation method and application thereof.

[0007] In a first aspect, the present invention provides a Chinese medicine composition for improving dysphagia, wherein the Chinese medicine composition for improving dysphagia comprises the following components in parts by weight:

[0008] 28-35 parts of Herba Lycopodiellae, 15-24 parts of Rhizoma Cibotii, 10-18 parts of Radix Ophiopogonis, 5-10 parts of Scrophulariae, 8-15 parts of Acorus calamus, 5-10 parts of Cinnamon bark, and 3-6 parts of Licorice.

[0009] Furthermore, the Chinese medicine composition for improving dysphagia comprises the following components in parts by weight:

[0010] 30 parts of Herba Chrysanthemi Indici, 21.5 parts of Radix Lycopodiellae, 15 parts of Radix Ophiopogonis, 8 parts of Scrophulariae, 12 parts of Acorus Calamus, 8 parts of Cortex Cinnamomi, and 5 parts of Radix Glycyrrhizae.

[0011] In a second aspect, based on the same inventive concept, the present invention provides a method for preparing the Chinese medicine composition for improving dysphagia as described in any one of the first aspects, such as Figure 1 As shown, the preparation method of the Chinese medicine composition for improving dysphagia comprises the following steps:

[0012] Adding Herba Glechomae Root and Herba Glechomae Root to water for reflux extraction, and then concentrating and drying the obtained water extract to obtain a first extract;

[0013] Adding Ophiopogon japonicus, Scrophularia ningpoensis, Acorus calamus, Cinnamomum cassia and Glycyrrhiza uralensis into ethanol for ultrasonic-assisted heating extraction, and then concentrating and drying the obtained alcohol extract to obtain a second extract;

[0014] The first extract and the second extract are mixed and crushed, and then sieved to obtain the traditional Chinese medicine composition for improving dysphagia.

[0015] Furthermore, the working condition parameters of the reflux extraction include: pressure of 32 kPa to 45 kPa, temperature of 75° C. to 86° C., time of 60 to 90 minutes, and number of times of 1 to 3 times.

[0016] Furthermore, the weight ratio of the total weight of the Herba Lycopodii and the Herba Lycopodii to the water is (1-2):(5-10).

[0017] Furthermore, the working condition parameters of the ultrasonic assisted heating extraction include: ultrasonic power of 300-450W, heating temperature of 50°C-65°C, time of 1-2 hours, and number of times of 1-3 times.

[0018] Further, the volume fraction of the ethanol is 70-85%, and the weight ratio of the total weight of Ophiopogon japonicus, Scrophularia ningpoensis, Acorus tatarinowii, Cinnamomum cassia, and Glycyrrhiza uralensis to the weight of the ethanol is (1-2):(8-12).

[0019] In a third aspect, based on the same inventive concept, the present invention provides an application of a traditional Chinese medicine composition for improving dysphagia according to any one of the first aspect or a traditional Chinese medicine composition for improving dysphagia prepared by the preparation method of the traditional Chinese medicine composition for improving dysphagia according to any one of the second aspect in the preparation of a drug for treating and improving dysphagia.

[0020] Further, the dosage form of the drug for treating and improving dysphagia includes an oral dosage form, an injection dosage form, a respiratory tract dosage form, or a skin dosage form.

[0021] Further, the type of dysphagia includes post-stroke dysphagia.

[0022] The above technical solutions provided by the embodiments of the present invention have at least the following advantages compared with the prior art:

[0023] The embodiments of the present invention provide a traditional Chinese medicine composition for improving dysphagia, its preparation method and application. The present invention uses Penthorum chinense Pursh and Ligusticum citriodorum Hance as the monarch drugs, and cooperates with Ophiopogon japonicus, Scrophularia ningpoensis, and Acorus tatarinowii as the ministerial drugs to enhance the efficacy of the monarch drugs; Cinnamomum cassia is used as the adjuvant drug to warm and dredge the meridians and promote the circulation of qi and blood; Glycyrrhiza uralensis is used as the guiding drug to harmonize all the drugs. Animal experiments show that the traditional Chinese medicine composition provided by the present invention can significantly improve the swallowing function of the tMCAO (transient middle cerebral artery ischemia-reperfusion model) rat model, provides a new treatment means for dysphagia diseases, and has very important significance for improving the quality of life of patients with dysphagia caused by diseases such as stroke. Specifically:

[0024] 1. Monarch drugs:

[0025] Penthorum chinense Pursh: It has the effects of clearing heat and detoxifying, and promoting diuresis and removing dampness, can improve the damp-heat environment in the body, and helps to eliminate dysphagia caused by the accumulation of dampness and heat.

[0026] Ligusticum citriodorum Hance: It has the functions of dispelling wind and clearing heat, promoting qi and relieving pain, and activating blood circulation and removing stasis, can dredge the meridians, promote the circulation of qi and blood, and has good effects on dysphagia caused by qi and blood stasis.

[0027] Penthorum chinense Pursh and Ligusticum citriodorum Hance together serve as the monarch drugs, aiming at the etiologies of qi and blood stagnation and meridian blockage in dysphagia, and jointly play the core roles of clearing heat and detoxifying, dredging qi and blood, and dredging meridians, laying a foundation for improving dysphagia.

[0028] 2. Ministerial drugs:

[0029] Ophiopogon japonicus: Nourishes yin and promotes fluid production, moistens the lungs and clears the heart, can moisten the throat and relieve discomfort such as dryness of the throat caused by insufficient body fluids.

[0030] Scrophularia ningpoensis: Clears heat and cools the blood, nourishes yin and reduces fire, helps to clear heat toxins in the body, alleviates inflammation and swelling in the throat, further enhances the power of nourishing yin and moistening dryness, while assisting the monarch drug to improve qi and blood circulation, nourishes the yin fluid of the local throat.

[0031] Acorus tatarinowii: Resuscitates the mind and opens the orifices, promotes digestion and harmonizes the stomach, can open the orifices and unblock the obstruction, enhances the swallowing reflex, promotes the local qi and blood circulation, and enhances the effect of the monarch drug in dredging the meridians.

[0032] Ophiopogon japonicus, Scrophularia ningpoensis and Acorus tatarinowii together serve as the ministerial drugs, assisting the monarch drug to exert its efficacy, enhancing the efficacy of the monarch drug in improving qi and blood, nourishing the throat, etc. from different aspects such as nourishing yin, clearing heat, and dredging meridians, and further improving dysphagia.

[0033] 3. Adjuvant drugs:

[0034] Cinnamomum cassia: Warming the middle and dispelling cold, warming and unblocking the meridians, can promote the qi and blood circulation. In the whole prescription, the warm nature of Cinnamomum cassia can stimulate the body's yang qi, promote the qi and blood to run in the meridians, so that the drugs can play their roles better. Especially for the situation of slow qi and blood circulation and meridian blockage caused by brain lesions, Cinnamomum cassia can play a role in activating qi and blood, assisting the monarch drug and ministerial drug to better improve dysphagia.

[0035] 4. Guiding drug:

[0036] Glycyrrhiza uralensis: Tonifying the spleen and replenishing qi, clearing heat and detoxifying, coordinating the actions of various drugs. As the guiding drug, Glycyrrhiza uralensis can coordinate the properties of various drugs in the prescription, enable various drugs to work together, and jointly play the role of improving dysphagia.

[0037] In summary, the embodiment of the present invention provides a traditional Chinese medicine composition for improving dysphagia. In this traditional Chinese medicine composition, the monarch drug plays a major therapeutic role against the cause, the ministerial drugs enhance the efficacy of the monarch drug from different angles, the adjuvant drugs assist the monarch drug and ministerial drug to improve qi and blood circulation, and the guiding drug coordinates the actions of various drugs. Each drug cooperates with each other and acts synergistically. By regulating qi and blood, dredging meridians, nourishing body fluids and other aspects, it restores the normal physiological function of the throat, can significantly improve the swallowing function of the tMCAO rat model, and provides an effective treatment means for dysphagia diseases. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] The accompanying drawings here are incorporated into the description and form a part of this description, showing embodiments consistent with the present invention, and are used together with the description to explain the principles of the present invention.

[0039] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings required for the description of the embodiments or the prior art. Obviously, for those of ordinary skill in the art, without creative efforts, other drawings can also be obtained based on these drawings.

[0040] Figure 1 It is a schematic flowchart of a preparation method of a traditional Chinese medicine composition for improving dysphagia provided by an embodiment of the present invention. Detailed implementation manners

[0041] To make the objectives, technical solutions and advantages of the embodiments of the present invention clearer, the following will clearly and completely describe the technical solutions in the embodiments of the present invention with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are some but not all of the embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts belong to the scope of protection of the present invention.

[0042] Unless otherwise specifically stated, various raw materials, reagents, instruments and equipment used in the present invention can all be obtained through market purchase or prepared by existing methods.

[0043] In a first aspect, the present invention provides a traditional Chinese medicine composition for improving dysphagia. Calculated by weight parts, the traditional Chinese medicine composition for improving dysphagia includes the following components:

[0044] 28 - 35 parts of Penthorum chinense Pursh, 15 - 24 parts of Ligusticum sciadophyllum Hance, 10 - 18 parts of Ophiopogon japonicus (Thunb.) Ker-Gawl., 5 - 10 parts of Scrophularia ningpoensis Hance, 8 - 15 parts of Acorus tatarinowii Schott, 5 - 10 parts of Cinnamomum cassia Presl, 3 - 6 parts of Glycyrrhiza uralensis Fisch.

[0045] The embodiment of the present invention provides a traditional Chinese medicine composition for improving dysphagia. The present invention uses Penthorum chinense Pursh and Ligusticum sciadophyllum Hance as the monarch drugs, and cooperates with Ophiopogon japonicus (Thunb.) Ker-Gawl., Scrophularia ningpoensis Hance, and Acorus tatarinowii Schott as the ministerial drugs to enhance the efficacy of the monarch drugs; Cinnamomum cassia Presl is used as the adjuvant drug to warm and dredge the meridians and promote the flow of qi and blood; Glycyrrhiza uralensis Fisch. is used as the guiding drug to harmonize all the drugs. Animal experiments show that the traditional Chinese medicine composition provided by the present invention can significantly improve the swallowing function of the tMCAO rat model, providing a new treatment method for dysphagia diseases, and having very important significance for improving the quality of life of patients with dysphagia caused by diseases such as stroke.

[0046] In the present invention, Penthorum chinense Pursh is the whole herb of Penthorum chinense Pursh, a plant of the genus Penthorum in the Saxifragaceae family, also known as P. chinense Pursh, Erechtites hieraciifolius (L.) Raf., and Herba Penthori Chinensis, etc. According to records in "Tianbao Bencao" and "Jiuhuang Bencao", Penthorum chinense Pursh has the effects of dredging collaterals and promoting blood circulation, removing stasis and dampness, and promoting blood circulation to remove stasis.

[0047] In the present invention, the root of Ostericum citriodorum (Hance) Yuan et Shan, a plant of the Umbelliferae family, is used as the Ge-shan-xiang, which has the effects of dispelling wind and clearing heat, promoting qi flow to relieve pain, activating blood circulation and dispelling stasis, etc.

[0048] In the present invention, the dried tuberous roots of Ophiopogon japonicus (Thunb.) Ker-Gawl., a plant of the Liliaceae family, are used as the Mai-dong, which has the effects of nourishing yin and promoting fluid production, moistening the lungs and clearing the heart, etc.

[0049] In the present invention, the dried root of Scrophularia ningpoensis Hemsl., a herbaceous plant of the genus Scrophularia in the Scrophulariaceae family, is used as the Xuan-shen, which has the effects of relieving fever and thirst, regulating internal fire, reducing skin swelling and redness, etc.

[0050] In the present invention, Acorus tatarinowii Schott has the following aliases: Jiujie Changpu, Shan Changpu, Yao Changpu, Jinqian Pu, Changpu Ye, Shuijian Cao, Xiang Changpu, etc., and its rhizome is used as medicine.

[0051] In the present invention, the dried bark of Cinnamomum cassia Presl, a plant of the Lauraceae family, is also known as Guipi, Guanguai, Yugui, etc.

[0052] In the present invention, the dried roots and rhizomes of Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat. or Glycyrrhiza glabra L., plants of the Leguminosae family, are used as the Gan-cao, which is a commonly used traditional Chinese medicine for regulating the properties of drugs, and has the effects of relieving sore throat, relieving cough and resolving phlegm, enhancing the function of the spleen and stomach, etc. It can not only neutralize the toxicity of drugs but also reconcile the properties of different medicinal materials.

[0053] In some specific embodiments, based on parts by weight, the traditional Chinese medicine composition for improving dysphagia comprises the following components:

[0054] 30 parts of Penthorum chinense Pursh, 21.5 parts of Ostericum citriodorum (Hance) Yuan et Shan, 15 parts of Ophiopogon japonicus (Thunb.) Ker-Gawl., 8 parts of Scrophularia ningpoensis Hemsl., 12 parts of Acorus tatarinowii Schott, 8 parts of Cinnamomum cassia Presl, and 5 parts of Glycyrrhiza uralensis Fisch.

[0055] Second, based on the same inventive concept, the present invention provides a preparation method of the traditional Chinese medicine composition for improving dysphagia according to any one of the first aspect, as Figure 1 shown, the preparation method of the traditional Chinese medicine composition for improving dysphagia comprises the following steps:

[0056] Add Penthorum chinense Pursh and Ostericum citriodorum (Hance) Yuan et Shan to water for reflux extraction, and then concentrate and dry the obtained water extract to obtain the first extract;

[0057] Add Ophiopogon japonicus (Thunb.) Ker-Gawl., Scrophularia ningpoensis Hemsl., Acorus tatarinowii Schott, Cinnamomum cassia Presl and Glycyrrhiza uralensis Fisch. to ethanol for ultrasonic-assisted heating extraction, and then concentrate and dry the obtained ethanol extract to obtain the second extract;

[0058] Mix and pulverize the first extract and the second extract, and then sieve to obtain the traditional Chinese medicine composition for improving dysphagia.

[0059] The preparation method of the traditional Chinese medicine composition for improving dysphagia provided by the embodiments of the present invention is simple in operation, does not require additional specific equipment, and is suitable for industrial mass production.

[0060] In some specific embodiments, the working condition parameters of the reflux extraction include: the pressure is 32 kPa to 45 kPa, preferably 40 kPa; the temperature is 75 °C to 86 °C, preferably 81.5 °C; the time is 60 to 90 minutes, and the number of times is 1 to 3 times.

[0061] In some specific embodiments, the weight ratio of the total weight of the Patrinia villosa and the Ligusticum wallichii to the weight of water is (1 - 2):(5 - 10), preferably 1.5:8.

[0062] In some specific embodiments, the working condition parameters of the ultrasonic-assisted heating extraction include: the ultrasonic power is 300 to 450 W, the heating temperature is 50 °C to 65 °C, the time is 1 to 2 hours, and the number of times is 1 to 3 times; preferably, the working condition parameters of the ultrasonic-assisted heating extraction include: the ultrasonic power is 380 W, the heating temperature is 60 °C, the extraction time is 1.5 hours, and the number of times is 1 to 3 times.

[0063] In some specific embodiments, the volume fraction of the ethanol is 70 - 85%, preferably an ethanol aqueous solution with a volume fraction of 80%; the weight ratio of the total weight of the Ophiopogon japonicus, Scrophularia ningpoensis, Acorus tatarinowii, Cinnamomum cassia, and Glycyrrhiza uralensis to the weight of the ethanol is (1 - 2):(8 - 12), preferably 1:10.

[0064] In a third aspect, based on the same inventive concept, the present invention provides an application of the traditional Chinese medicine composition for improving dysphagia according to any one of the first aspect or the traditional Chinese medicine composition for improving dysphagia prepared by the preparation method of the traditional Chinese medicine composition for improving dysphagia according to any one of the second aspect in the preparation of a drug for treating and improving dysphagia.

[0065] In some specific embodiments, the dosage forms of the drug for treating and improving dysphagia include oral dosage forms, injection dosage forms, respiratory dosage forms, or skin dosage forms. Specifically, the oral dosage forms in the present invention may specifically include, for example, tablets, capsules, granules, etc. In addition, there are also oral dosage forms in the oral cavity such as gargles, drops, etc.; injection dosage forms include intravenous injection, intramuscular injection, etc.; respiratory dosage forms include, for example, aerosols, sprays, etc.; skin dosage forms include, for example, ointments, creams, patches, etc.

[0066] In some specific embodiments, the type of dysphagia includes post-stroke dysphagia. Specifically, post-stroke dysphagia refers to many pathological conditions including stroke that lead to difficulty in swallowing, and the inability to complete the process of "safely delivering the food bolus from the mouth to the stomach without aspiration", which is a common symptom of stroke.

[0067] It should be noted that the components and raw materials involved in the Chinese medicine composition for improving dysphagia and its preparation method and application provided in the embodiments of the present invention, unless otherwise specified or specified, can be directly commercially available products or homemade using existing public preparation methods; at the same time, the steps and parameters involved, unless otherwise specified or specified, can be carried out according to the Chinese medicine preparation process steps and parameters disclosed in the prior art or directly using existing equipment according to the instruction manual, and the present document will not repeat them one by one.

[0068] The present invention will be further described below in conjunction with specific examples. It should be understood that these examples are intended only to illustrate the present invention and are not intended to limit the scope of the present invention. The experimental methods in the following examples that do not specify specific conditions are usually measured according to national standards. If there is no corresponding national standard, then the conditions recommended by the manufacturer are followed.

[0069] Example 1

[0070] This example provides a Chinese medicine composition for improving dysphagia, which comprises the following components in parts by weight:

[0071] 30 parts of Herba Chrysanthemi Indici, 21.5 parts of Radix Lycopodiellae, 15 parts of Radix Ophiopogonis, 8 parts of Scrophulariae, 12 parts of Acorus Calamus, 8 parts of Cortex Cinnamomi, and 5 parts of Radix Glycyrrhizae.

[0072] The preparation method of the above-mentioned Chinese medicine composition for improving dysphagia comprises the following steps:

[0073] Adding Herba Lycopodiellae and Herba Lycopodiellae to water for reflux extraction, wherein the weight ratio of the Herba Lycopodiellae and Herba Lycopodiellae to the water is 1.5:8, and the working condition parameters of the reflux extraction include: pressure of 40 kPa; temperature of 81.5° C.; time of 75 minutes, and number of times of 2 times; and then concentrating and drying the obtained water extract to obtain a first extract;

[0074] Adding Ophiopogon japonicus, Scrophularia ningpoensis, Acorus calamus, Cinnamon bark and Licorice to an ethanol aqueous solution with a volume fraction of 80% for ultrasonic-assisted heating extraction, wherein the weight ratio of the total weight of the Ophiopogon japonicus, Scrophularia ningpoensis, Acorus calamus, Cinnamon bark and Licorice to the ethanol is 1:10, and the working condition parameters of the ultrasonic-assisted heating extraction include: ultrasonic power of 380W, heating temperature of 60°C, extraction time of 1.5 hours, and number of times of 2 times; and then concentrating and drying the obtained alcohol extract to obtain a second extract;

[0075] The first extract and the second extract are mixed and crushed, and then passed through a 100-mesh sieve to obtain the traditional Chinese medicine composition for improving dysphagia.

[0076] Example 2

[0077] This example provides a Chinese medicine composition for improving dysphagia, which comprises the following components in parts by weight:

[0078] 28 parts of Herba Chrysanthemi Indici, 15 parts of Rhizoma Cyperi, 10 parts of Radix Ophiopogonis, 5 parts of Scrophulariae, 8 parts of Acorus Calamus, 5 parts of Cortex Cinnamomi, and 3 parts of Radix Glycyrrhizae.

[0079] The preparation method of the above-mentioned Chinese medicine composition for improving dysphagia comprises the following steps:

[0080] Adding Herba Lycopodiellae and Herba Lycopodiellae to water for reflux extraction, wherein the weight ratio of the Herba Lycopodiellae and Herba Lycopodiellae to the water is 1.5:8, and the working condition parameters of the reflux extraction include: pressure of 32 kPa; temperature of 75° C.; time of 60 minutes, and number of times of 2 times; and then concentrating and drying the obtained water extract to obtain a first extract;

[0081] Adding Ophiopogon japonicus, Scrophularia ningpoensis, Acorus calamus, Cinnamon bark and Licorice to an ethanol aqueous solution with a volume fraction of 70% for ultrasonic-assisted heating extraction, wherein the weight ratio of the total weight of the Ophiopogon japonicus, Scrophularia ningpoensis, Acorus calamus, Cinnamon bark and Licorice to the ethanol is 1:10, and the working condition parameters of the ultrasonic-assisted heating extraction include: ultrasonic power of 300W, heating temperature of 65°C, extraction time of 1 hour, and number of times of 2 times; and then concentrating and drying the obtained alcohol extract to obtain a second extract;

[0082] The first extract and the second extract are mixed and crushed, and then passed through a 100-mesh sieve to obtain the traditional Chinese medicine composition for improving dysphagia.

[0083] Example 3

[0084] This example provides a Chinese medicine composition for improving dysphagia, which comprises the following components in parts by weight:

[0085] 35 parts of Penthorum chinense, 24 parts of Ligusticum sciadophyllum, 18 parts of Ophiopogon japonicus, 10 parts of Scrophularia ningpoensis, 15 parts of Acorus tatarinowii, 10 parts of Cinnamomum cassia, 6 parts of Glycyrrhiza uralensis.

[0086] The preparation method of the above traditional Chinese medicine composition for improving dysphagia includes the following steps:

[0087] Add Penthorum chinense and Ligusticum sciadophyllum into water for reflux extraction. The weight ratio of the total weight of Penthorum chinense and Ligusticum sciadophyllum to the weight of water is 1.5:8. The working condition parameters of the reflux extraction include: pressure is 45 kPa; temperature is 86 °C; time is 90 minutes, and the number of times is 2 times; then concentrate and dry the obtained water extract to obtain the first extract;

[0088] Add Ophiopogon japonicus, Scrophularia ningpoensis, Acorus tatarinowii, Cinnamomum cassia and Glycyrrhiza uralensis into an ethanol aqueous solution with a volume fraction of 70% for ultrasonic-assisted heating extraction. The weight ratio of the total weight of Ophiopogon japonicus, Scrophularia ningpoensis, Acorus tatarinowii, Cinnamomum cassia and Glycyrrhiza uralensis to the weight of ethanol is 1:10. The working condition parameters of the ultrasonic-assisted heating extraction include: ultrasonic power is 450 W, heating temperature is 50 °C, extraction time is 2 hours, and the number of times is 2 times; then concentrate and dry the obtained ethanol extract to obtain the second extract;

[0089] Mix and pulverize the first extract and the second extract, and then pass through a 100-mesh sieve to obtain the traditional Chinese medicine composition for improving dysphagia.

[0090] Comparative Example 1

[0091] This example provides a traditional Chinese medicine composition for improving dysphagia and its preparation method. The difference from Example 1 is only that: replace Penthorum chinense with Rabdosia serra; the remaining steps and parameters are the same.

[0092] Comparative Example 2

[0093] This example provides a traditional Chinese medicine composition for improving dysphagia and its preparation method. The difference from Example 1 is only that: replace Ligusticum sciadophyllum with Angelica dahurica; the remaining steps and parameters are the same.

[0094] Comparative Example 3

[0095] This example provides a traditional Chinese medicine composition for improving dysphagia and its preparation method. The difference from Example 1 is only that: adjust the dosage of Ligusticum sciadophyllum to 35 parts and the weight of Penthorum chinense to 16.5 parts; the remaining steps and parameters are the same.

[0096] Test Example

[0097] In this example, according to the preparation method of the animal model of dysphagia after stroke disclosed in the prior art, the therapeutic effect of the traditional Chinese medicine composition on the swallowing function of rats in the transient middle cerebral artery ischemia-reperfusion (tMCAO) model was evaluated.

[0098] The test method is as follows:

[0099] I. Preparation of experimental animals and test sample solutions

[0100] 1. Experimental animals: A number of male SD rats weighing 240 ± 5 g were selected to ensure the animals were healthy and in good vitality.

[0101] 2. Preparation of test sample solutions: The traditional Chinese medicine compositions obtained in Examples 1 to 3 and Comparative Examples 1 to 3 were accurately dissolved in sterile water respectively to prepare test sample solutions with a mass concentration of 0.5 g / ml, ensuring the solutions were uniform and without precipitation.

[0102] II. Modeling method

[0103] 1. Adaptive feeding: Male SD rats were adaptively fed for one week to adapt to the experimental environment.

[0104] 2. Preoperative preparation: Fast the rats for 12 hours without restricting water intake to reduce interference during the operation.

[0105] 3. Anesthesia and surgical operation:

[0106] Anesthetize the rats by intraperitoneal injection of 10% chloral hydrate (0.35 mL / 100 g) to ensure stable anesthesia effect.

[0107] Fix the rats. After disinfecting and shaving the neck, make a longitudinal incision about 1.5 cm along the midline of the neck.

[0108] Bluntly separate the muscle space between the sternocleidomastoid muscle and the sternohyoid muscle, and carefully expose the common carotid artery.

[0109] Separate the common carotid artery, external carotid artery and internal carotid artery in sequence, and ligate the proximal ends of the external carotid artery and the common carotid artery.

[0110] Leave a slipknot at the common carotid artery near the bifurcation of the internal carotid artery and the external carotid artery for subsequent operations.

[0111] Use an artery clip to clamp the internal carotid artery, and insert the MCAO nylon suture into the common carotid artery with the assistance of a 2 mL syringe needle.

[0112] Pull out the needle, continue to insert the MCAO nylon suture to the predetermined position, release the artery clip of the internal carotid artery, and make the suture enter the internal carotid artery about 19 mm.

[0113] Ligate the common carotid artery at the slipknot at the distal end to fix the suture.

[0114] Suture the incision layer by layer, and blacken the end of the MCAO nylon thread left outside with an oil-based pen for marking.

[0115] 4. Postoperative treatment: Each rat was given an intraperitoneal injection of 40,000 IU of penicillin to prevent infection.

[0116] 5. Reperfusion operation: After 90 minutes, carefully pull out about 1 cm of the MCAO nylon thread plug, cut off the pulled-out part of the thread plug, and complete the operation. Except for not inserting the MCAO nylon thread plug, the rest of the surgical procedures for the sham operation group were the same as those for the model group.

[0117] III. Grouping and drug administration

[0118] 1. Grouping: The male SD rats were randomly divided into a normal group (1 group), a sham operation group (1 group), a model group (1 group), and a drug administration treatment group (6 groups), with 10 rats in each group.

[0119] 2. Drug administration: The model group and the drug administration treatment group were subjected to the modeling operation. Starting from the second day after modeling, the 6 drug administration treatment groups were respectively given the sample solutions prepared with the traditional Chinese medicine compositions obtained in Examples 1 to 3 and Comparative Examples 1 to 3 for intervention treatment, with 0.1 mL dropped on the tongue once a day for each rat. The normal group, the sham operation group, and the model group were given an equal amount of normal saline dropped on the tongue as a control.

[0120] IV. Detection and statistics of the number of swallows and swallowing reaction time indicators

[0121] 1. Detection preparation: After 14 days of drug administration, the rats were anesthetized by intraperitoneal injection of chloral hydrate.

[0122] 2. Surgical exposure: Make an incision about 1 cm in the midline of the neck to expose the anterior belly of the digastric muscle.

[0123] 3. Connect the device: One end of the tension transducer is connected to the anterior belly of the digastric muscle, and the other end is connected to the biological signal transducer.

[0124] 4. Stimulation and recording:

[0125] Insert a 0.5-mm-diameter hose through the rat's oral cavity to reach the root of the tongue.

[0126] Use a micro-injection pump to inject distilled water at a speed of 3 μL / s for 30 seconds, repeat again after stopping for 1 minute, and repeat a total of 3 times.

[0127] Accurately record the number of swallows and the time from the start of stimulation to the first swallow (swallowing reaction time) through the biological signal acquisition system.

[0128] 5. Data statistics and analysis: Organize the test results and conduct statistical analysis, as shown in Table 1.

[0129] Table 1

[0130] Test Group Swallowing Frequency (times / 30s) Swallowing Reaction Time (s) Normal Group 15 2.6 Sham Operation Group 16 4.9 Model Group 8 5.4 Drug Administration Treatment Group of Example 1 14 2.8 Drug Administration Treatment Group of Example 2 12 3.2 Drug Administration Treatment Group of Example 3 13 3.1 Drug Administration Treatment Group of Comparative Example 1 10 4.0 Drug Administration Treatment Group of Comparative Example 2 9 4.2 Drug Administration Treatment Group of Comparative Example 3 10 3.8

[0131] As can be seen from Table 1, compared with the rats in the normal group, the number of swallows of the rats in the model group on the 14th day after modeling was significantly reduced and the swallowing reaction time was delayed; compared with the rats in the model group, the number of swallows of the administration treatment groups of Examples 1 to 3 treated with the traditional Chinese medicine compositions obtained in Examples 1 to 3 of the present invention was significantly increased and the swallowing reaction time was shortened, and the intervention treatment effect was significantly better than that of the administration treatment groups of Comparative Examples 1 to 3.

[0132] In summary, the embodiments of the present invention provide a traditional Chinese medicine composition for improving dysphagia, its preparation method and application. The present invention uses Penthorum chinense Pursh and Ligusticum citriodorum Hance as the monarch drugs, and cooperates with Ophiopogon japonicus, Scrophularia ningpoensis and Acorus tatarinowii as the ministerial drugs to enhance the efficacy of the monarch drugs; Cinnamon is used as the adjuvant drug to warm and dredge the meridians and promote the circulation of qi and blood; Licorice is used as the guiding drug to harmonize all drugs. Animal experiments show that the traditional Chinese medicine composition provided by the present invention can significantly improve the swallowing function of the tMCAO rat model, provides a new treatment means for dysphagia diseases, and has very important significance for improving the quality of life of patients with dysphagia caused by diseases such as stroke.

[0133] The various embodiments of the present invention may exist in the form of a range; it should be understood that the description in the form of a range is only for convenience and brevity, and should not be construed as a rigid limitation on the scope of the present invention; therefore, it should be considered that the described range description has specifically disclosed all possible sub-ranges and single values within that range. For example, it should be considered that the range description from 1 to 6 has specifically disclosed sub-ranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6, etc., and single numbers within that range, such as 1, 2, 3, 4, 5, and 6, which applies regardless of the range. In addition, whenever a numerical range is indicated herein, it means including any cited number (fraction or integer) within the indicated range.

[0134] The above are only specific embodiments of the present invention, which enable those skilled in the art to understand or implement the present invention. Various modifications to these embodiments will be obvious to those skilled in the art, and the general principles defined herein can be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention will not be limited to these embodiments shown herein, but will conform to the widest scope consistent with the principles and novel features claimed herein.

Claims

1. A traditional Chinese medicine composition for improving dysphagia, characterized in that, The traditional Chinese medicine composition for improving dysphagia comprises the following components in parts by weight: 28 - 35 parts of Penthorum chinense Pursh, 15 - 24 parts of Ligusticum sciadophyllum Hance, 10 - 18 parts of Ophiopogon japonicus (Thunb.) Ker-Gawl., 5 - 10 parts of Scrophularia ningpoensis Hemsl., 8 - 15 parts of Acorus tatarinowii Schott, 5 - 10 parts of Cinnamomum cassia Presl, 3 - 6 parts of Glycyrrhiza uralensis Fisch.

2. The traditional Chinese medicine composition for improving dysphagia according to claim 1, wherein, The traditional Chinese medicine composition for improving dysphagia comprises the following components in parts by weight: 30 parts of Penthorum chinense Pursh, 21.5 parts of Ligusticum sciadophyllum Hance, 15 parts of Ophiopogon japonicus (Thunb.) Ker-Gawl., 8 parts of Scrophularia ningpoensis Hemsl., 12 parts of Acorus tatarinowii Schott, 8 parts of Cinnamomum cassia Presl, 5 parts of Glycyrrhiza uralensis Fisch.

3. A method for preparing the traditional Chinese medicine composition for improving dysphagia according to claim 1 or 2, characterized in that, The preparation method of the traditional Chinese medicine composition for improving dysphagia comprises the following steps: Add Penthorum chinense Pursh and Ligusticum sciadophyllum Hance into water for reflux extraction, and then concentrate and dry the obtained water extract to obtain a first extract; Add Ophiopogon japonicus (Thunb.) Ker-Gawl., Scrophularia ningpoensis Hemsl., Acorus tatarinowii Schott, Cinnamomum cassia Presl and Glycyrrhiza uralensis Fisch. into ethanol for ultrasonic-assisted heating extraction, and then concentrate and dry the obtained ethanol extract to obtain a second extract; Mix and pulverize the first extract and the second extract, and then sieve to obtain the traditional Chinese medicine composition for improving dysphagia.

4. The preparation method of the traditional Chinese medicine composition for improving dysphagia according to claim 3, characterized in that The working condition parameters of the reflux extraction include: the pressure is 32 kPa - 45 kPa, the temperature is 75 °C - 86 °C, the time is 60 - 90 minutes, and the number of times is 1 - 3 times.

5. The preparation method of the traditional Chinese medicine composition for improving dysphagia according to claim 4, wherein, The weight ratio of the total weight of Penthorum chinense Pursh and Ligusticum sciadophyllum Hance to the weight of water is (1 - 2):(5 - 10).

6. The preparation method of the traditional Chinese medicine composition for improving dysphagia according to claim 3, characterized in that, The working condition parameters of the ultrasonic-assisted heating extraction include: the ultrasonic power is 300 - 450 W, the heating temperature is 50 °C - 65 °C, the time is 1 - 2 hours, and the number of times is 1 - 3 times.

7. The preparation method of the traditional Chinese medicine composition for improving dysphagia according to claim 6, wherein, The volume fraction of the ethanol is 70 - 85%, and the weight ratio of the total weight of Ophiopogon japonicus (Thunb.) Ker-Gawl., Scrophularia ningpoensis Hemsl., Acorus tatarinowii Schott, Cinnamomum cassia Presl and Glycyrrhiza uralensis Fisch. to the weight of the ethanol is (1 - 2):(8 - 12).

8. Use of the traditional Chinese medicine composition for improving dysphagia according to any one of claims 1 - 2 or the traditional Chinese medicine composition prepared by the preparation method of the traditional Chinese medicine composition for improving dysphagia according to any one of claims 3 - 7 in the preparation of a drug for treating and improving dysphagia.

9. The application according to claim 8, characterized in that, The dosage form of the drug for treating and improving dysphagia includes an oral dosage form, an injection dosage form, a respiratory tract dosage form or a skin dosage form.

10. The application according to claim 8, characterized in that, The type of the dysphagia includes post-stroke dysphagia.

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