Traditional Chinese medicine composition for treating fatigue and throat discomfort symptoms as well as preparation method and application thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating fatigue and throat discomfort symptoms as well as a preparation method and application of the traditional Chinese medicine composition. The traditional Chinese medicine composition is prepared from the following raw materials in parts by mass: 30-50 parts of American ginseng and 1 part of pummelo peel. The American ginseng with the effects of tonifying qi, nourishing yin, clearing heat and promoting salivation and the pummelo peel embryo with the effects of relieving cough and reducing sputum are combined according to the mass ratio of (30-50): 1, and the obtained traditional Chinese medicine preparation can effectively treat prominent symptoms of continuous fatigue and sore throat of the chronic fatigue syndrome. The traditional Chinese medicine formula can help a patient to relieve fatigue and sore throat symptoms through endogenous treatment, has the advantages of being remarkable in curative effect, small in raw material side effect, low in price and simple in medicine, and has important significance in development and application of products for tonifying qi, nourishing yin, clearing heat from throat and reducing phlegm.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating fatigue and throat discomfort symptoms, and a preparation method and application thereof. Background Art

[0002] Chronic Fatigue Syndrome (CFS) is a complex disease characterized by long-term fatigue, often accompanied by symptoms such as headache, insomnia, and memory loss. According to traditional Chinese medicine, most CFS patients have a weak constitution, with symptoms such as lack of energy, laziness, weak pulse, and fatigue, which are caused by the depletion of vital energy due to organ deficiency and long-term illness. CFS can have a serious impact on patients' daily life, work, and social activities. In addition, the immune system abnormalities associated with CFS can also lead to the occurrence of other diseases, and decreased immunity is one of the main causes of chronic pharyngitis. In the survey of the "White Paper on the Status of National Health and Immunity Improvement in the Post-epidemic Era", 76% of the respondents believed that staying up late would cause a decrease in immunity. According to the "2023 National Throat Health White Paper", the frequency of pharyngitis is higher among people who stay up late. Modern medicine has not yet clarified the pathogenesis of CFS, but some experts believe that social and psychological factors are one of the factors leading to the onset of CFS. With the acceleration of people's pace of life, unhealthy work and rest, and the increase in life and work pressure, the incidence of CFS has gradually increased, and more and more people are deeply troubled. Chinese medicine believes that to improve chronic fatigue syndrome, it is necessary to focus on replenishing qi. In daily health care, qi-replenishing Chinese medicine can be used to replenish qi, blood, yin and yang, relieve fatigue and enhance immunity. In addition, chronic fatigue syndrome is often accompanied by the occurrence of chronic pharyngitis, and the current common Chinese medicine prescriptions for the treatment of chronic fatigue have no therapeutic effect on throat discomfort. Therefore, there is a great demand for qi-replenishing and yin-nourishing, throat-clearing and throat-relief products in the current market, and it is particularly urgent to accelerate the development of related products. Summary of the invention

[0003] In order to overcome the problems existing in the above-mentioned prior art, one of the purposes of the present invention is to provide a Chinese medicine composition. The second purpose of the present invention is to provide a method for preparing the above-mentioned Chinese medicine composition. The third purpose of the present invention is to provide a pharmaceutical composition. The fourth purpose of the present invention is to provide the above-mentioned Chinese medicine composition and the application of the pharmaceutical composition.

[0004] In order to achieve the above object, the technical solution adopted by the present invention is:

[0005] The first aspect of the present invention provides a traditional Chinese medicine composition, which is prepared by comprising the following raw materials in parts by weight: 30-50 parts of American ginseng and 1 part of Citrus aurantium.

[0006] American ginseng is the dried root of the Araliaceae plant American ginseng. It is dug in autumn, washed, and dried in the sun or at low temperature. It is a cultivated product. American ginseng has a slight and unique smell, a slightly bitter and sweet taste, and a cool nature. It enters the heart, lung, and kidney meridians. It has the effects of replenishing qi and nourishing yin, clearing heat and promoting body fluid. It is a product that replenishes both qi and yin. Compared with ginseng, American ginseng is cooler in nature, tends to be more clear and nourishing, and can also nourish yin. Modern pharmacological studies have shown that American ginseng has the effects of improving insulin resistance, lowering blood lipids, resisting arrhythmia, protecting myocardial cells, resisting fatigue, resisting tumors, and promoting hematopoiesis.

[0007] Huajuhongtai is the dried young fruit of Huazhou pomelo, a plant of the Rutaceae family. It is a product made by washing, killing green, drying, forming or not forming, slicing or not slicing, packaging, and storing fresh Huazhou pomelo fruit with a fruit diameter of 4 to 8 cm. Huajuhongtai has a long history of medicinal use. It has the effects of regulating qi and relieving fullness, drying dampness and resolving phlegm. It is used for cough with phlegm, food accumulation and alcohol damage, nausea and stuffiness. Naringin is one of the main active ingredients of Huajuhongtai for relieving cough and reducing phlegm. Its metabolite naringenin can play a cough and phlegm-resolving effect through various pathways; Huajuhong polysaccharide has anti-inflammatory, expectorant and cough-relieving, antioxidant, and immunomodulatory effects; limonene in Huajuhong volatile oil has anti-inflammatory and antibacterial effects.

[0008] Traditional Chinese medicine believes that the occurrence of chronic fatigue syndrome is closely related to "lack of vital energy". Based on the theory of traditional Chinese medicine that "the root cause of the disease must be sought", the present invention selects American ginseng and Citrus aurantium embryo as raw materials to prepare a traditional Chinese medicine preparation with the effects of invigorating qi and nourishing yin, clearing the throat and resolving phlegm.

[0009] Preferably, it is prepared from the following raw materials in parts by mass: 35-45 parts of American ginseng and 1 part of Citrus aurantium embryo.

[0010] More preferably, it is prepared from the following raw materials in parts by mass: 37-43 parts of American ginseng and 1 part of Citrus aurantium embryo.

[0011] Preferably, the Chinese medicine composition is a water extract of a mixture of various raw materials, or the sum of water extracts extracted separately.

[0012] The second aspect of the present invention provides a method for preparing the Chinese medicine composition of the first aspect, comprising the following steps: mixing American ginseng and Citrus aurantium wilfordii embryo and performing one or more water extractions to obtain an extract of the Chinese medicine composition.

[0013] Preferably, the American ginseng used in the preparation method is fresh slices of American ginseng.

[0014] Preferably, the Huajuhong embryo used in the preparation method is Huajuhong embryo slices.

[0015] Preferably, the water extraction process comprises: performing a first water extraction at 55-65°C, performing a second water extraction at 55-65°C, and then performing a third water extraction at 95-100°C.

[0016] More preferably, the mass volume ratio of the sum of the American ginseng and the Citrus aurantium embryo to the water usage of the first water extraction is (0.5-1.5) g:1 mL.

[0017] More preferably, the first water extraction is followed by filtration to obtain a medicinal solution 1 and a medicinal residue 1, and the medicinal residue 1 is subjected to a second water extraction.

[0018] Further preferably, the volume ratio of water used in the second water extraction to that in the first water extraction is (0.5-1):1.

[0019] More preferably, the second water extraction is followed by filtration to obtain a medicinal solution 2 and a medicinal residue 2, and the medicinal residue 2 is subjected to a third water extraction.

[0020] Further preferably, the volume ratio of water used in the third water extraction to that in the first water extraction is (1-2):1.

[0021] More preferably, the first water extraction time is 10-20 min.

[0022] More preferably, the second water extraction time is 3-10 min.

[0023] More preferably, the third water extraction time is 25-35 min.

[0024] The third aspect of the present invention provides a pharmaceutical composition, which is prepared from the traditional Chinese medicine composition described in the first aspect and a pharmaceutically acceptable carrier.

[0025] For those skilled in the art, the above-mentioned pharmaceutically acceptable pharmaceutical excipients are used to improve drug stability or give the drug an appropriate dosage form for transportation, carrying, storage or administration, such as surfactants, lubricants, preservatives, etc. The types of pharmaceutically acceptable pharmaceutical excipients, as well as the selection criteria and selection methods are well known to those skilled in the art. Through design methods such as orthogonal experiments, those skilled in the art do not need creative labor and can select suitable pharmaceutical excipients and their proportions and preparation processes through limited experiments. For pharmaceutically acceptable pharmaceutical excipients for Chinese medicine compound prescriptions, see Cui Lide's "Pharmaceutics" (Beijing: People's Medical Publishing House, published in 2007), Zhang Zhaowang's "Chinese Medicine Pharmacy" (Beijing: China Traditional Chinese Medicine Press, published in 2007), etc. For Chinese medicine oral granules, commonly used pharmaceutical excipients include starch, lactose, micropowder silica gel, microcrystalline cellulose, etc., and their uses and usage in preparations are well known to those skilled in the art, and their dosage is that those skilled in the art do not need creative labor and can directly obtain it through limited experiments.

[0026] Preferably, the dosage form of the pharmaceutical composition is selected from one of ointment, syrup, pill, capsule, granule, oral liquid, powder, tablet, lozenge and sugar lozenge.

[0027] Preferably, the raw materials of the syrup include the water extract of the mixed raw materials described in the first aspect or the sum of the water extracts extracted separately, and a sweetener.

[0028] More preferably, the syrup is prepared by a preparation method comprising the following steps: mixing the water extract obtained by mixing the raw materials described in the first aspect with a sweetener.

[0029] More preferably, the sweetener is maltitol.

[0030] The American ginseng and tangerine peel embryo stock solution has the effects of replenishing qi and nourishing yin, clearing the throat and resolving phlegm, but its flavor is not good despite the significant efficacy. Therefore, the present invention improves the original preparation process, adds maltitol liquid to adjust its flavor, and obtains the American ginseng and tangerine peel embryo stock solution with both flavor and efficacy.

[0031] The fourth aspect of the present invention provides use of the Chinese medicine composition described in the first aspect, or the medicine composition described in the third aspect in the preparation of a drug for preventing or treating symptoms of fatigue and throat discomfort.

[0032] Preferably, the Chinese medicine composition or the pharmaceutical composition is used in the preparation of a drug for preventing or treating symptoms of fatigue and throat discomfort caused by staying up late.

[0033] More preferably, the throat discomfort symptoms include sore throat, dry throat, and cough with sputum.

[0034] The beneficial effects of the present invention are:

[0035] The invention provides a Chinese medicine composition, wherein the western ginseng having the effects of invigorating qi and nourishing yin, clearing away heat and promoting body fluid and the tangerine peel having the effects of relieving cough and reducing phlegm are combined in a mass ratio of (30-50):1, and the obtained Chinese medicine preparation can effectively treat persistent fatigue and sore throat, which are prominent symptoms of chronic fatigue syndrome. The Chinese medicine formula of the invention can help patients relieve fatigue and sore throat symptoms through endogenous treatment, has the characteristics of significant efficacy, small side effects of raw materials, and low price and simple medicine, and has important significance in the development and application of products for invigorating qi and nourishing yin, clearing throat and reducing phlegm. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] Figure 1 This is the flow chart of process one and process two;

[0037] Figure 2 Flavor selection profile for the subjects. DETAILED DESCRIPTION

[0038] The present invention is further described in detail below through specific examples. The raw materials used in the following examples, unless otherwise specified, can be obtained from conventional commercial sources or prepared and separated by simple synthesis; the processes used, unless otherwise specified, are conventional processes in the art.

[0039] Example 1

[0040] This embodiment provides a traditional Chinese medicine stock solution, Figure 1 The present invention is a process flow of the preparation method of the Chinese medicine granules of Example 1, wherein the first process is the Chinese medicine stock solution without adding sweetener, and the second process is the Chinese medicine stock solution with adding sweetener.

[0041] The specific preparation steps of process 1 are as follows:

[0042] A1. Prepare materials: 20 kg of American ginseng slices (freshly sliced) and 0.5 kg of Citrus aurantium embryo slices. The Chinese medicinal materials are provided by Guangzhou Caizhilin Pharmaceutical Co., Ltd.

[0043] B1. Extraction: Add 200L of purified water to the Chinese medicine extraction tank, heat it to 60℃, add American ginseng slices and tangerine peel slices, keep the temperature between 55-60℃, filter with a 150-mesh filter bag after 15 minutes, and collect the filtrate. Add another 150L of purified water to the extraction tank, heat it to 60℃, keep it for 5 minutes, filter with a 150-mesh filter bag, and collect the filtrate. Add another 250L-280L (can be determined according to the evaporation volume of the extraction tank) of purified water to the extraction tank, boil it for 30 minutes, filter with a 150-mesh filter bag, and collect the filtrate.

[0044] C1. Filtration: Combine the filtrates from the three times and filter them using 200-mesh, 300-mesh, and 500-mesh filters in sequence to collect the filtrates.

[0045] D1. Add water: Add purified water to the filtrate to make up to 500L, and obtain the American ginseng and tangerine peel embryo stock solution for use.

[0046] E1. Repackaging: Repack the American ginseng and tangerine peel solution into glass bottles.

[0047] F1. Sterilization: Put the glass bottle into boiling water, boil for 15 minutes and then take it out. Sterilization is completed and the Chinese medicine stock solution is obtained.

[0048] The specific preparation steps of process 2 are as follows:

[0049] A2. Prepare materials: 20 kg of American ginseng slices (freshly sliced) and 0.5 kg of tangerine peel slices.

[0050] B2. Extraction: Add 200L of purified water to the Chinese medicine extraction tank, heat it to 60℃, add American ginseng slices and tangerine peel slices, keep the temperature between 55-60℃, filter with a 150-mesh filter bag after 15 minutes, and collect the filtrate. Add another 150L of purified water to the extraction tank, heat it to 60℃, keep it for 5 minutes, filter with a 150-mesh filter bag, and collect the filtrate. Add another 250L-280L (can be determined according to the evaporation volume of the extraction tank) of purified water to the extraction tank, boil it for 30 minutes, filter with a 150-mesh filter bag, and collect the filtrate.

[0051] C2. Filtration: Combine the filtrates from the three times and filter them using 200-mesh, 300-mesh, and 500-mesh filters in sequence, and collect the filtrates.

[0052] D2. Add maltitol solution: Add 25 kg of maltitol solution to the filtrate and stir well.

[0053] E2. Add water: Add purified water to the filtrate to make up to 500L to obtain the American ginseng and tangerine peel embryo stock solution for use.

[0054] F2. Repackaging: Repack the American ginseng and tangerine peel essence into glass bottles.

[0055] G2. Sterilization: After putting the glass bottle into boiling water, take it out after boiling for 15 minutes. The sterilization is completed and the Chinese medicine stock solution is obtained.

[0056] Example 2

[0057] This embodiment provides a Chinese medicine stock solution, and its preparation method is the same as process 1 in Example 1, except that: the water extraction raw materials are 20 kg of American ginseng slices (freshly sliced), 0.5 kg of Citrus aurantium embryo slices, and 0.5 kg of Momordica grosvenori.

[0058] Example 3

[0059] This embodiment provides a Chinese medicine stock solution, and its preparation method is the same as process 1 in Example 1, except that: the water extraction raw materials are 20 kg of American ginseng slices (freshly sliced), 0.5 kg of Citrus aurantium embryo slices, and 0.5 kg of loquat leaves.

[0060] Comparative Example 1

[0061] This embodiment provides a Chinese medicine stock solution, and its preparation method is the same as process 1 in Example 1, except that: the water extraction raw material is 20 kg of American ginseng slices (freshly sliced).

[0062] Comparative Example 2

[0063] This embodiment provides a Chinese medicine stock solution, and its preparation method is the same as process 1 in Example 1, except that: the water extraction raw material is 0.5 kg of Citrus aurantium embryo tablets.

[0064] Comparative Example 3

[0065] This embodiment provides a Chinese medicine stock solution, and its preparation method is the same as process 1 in Example 1, except that: the water extraction raw materials are 10 kg of American ginseng slices (freshly sliced) and 0.5 kg of Citrus aurantium embryo slices.

[0066] Comparative Example 4

[0067] This embodiment provides a Chinese medicine stock solution, and its preparation method is the same as process 1 in Example 1, except that: the water extraction raw materials are 30 kg of American ginseng slices (freshly sliced) and 0.5 kg of Citrus aurantium embryo slices.

[0068] Experimental analysis

[0069] 126 volunteers were recruited for the study. The subjects were required to meet the diagnostic criteria for CFS and not receive relevant treatment. The subjects were of both genders and aged between 20 and 50 years old. They were randomly divided into 7 groups. The test period was 1 week. The subjects took the drug orally, once in the morning and once in the evening, after meals. After the test, they filled in the questionnaire. The diagnostic criteria for CFS established by the Centers for Disease Control and Prevention (CDC) in the United States in 1994 are as follows: (1) Clinically assessed unexplained persistent or recurrent chronic fatigue, which is new or has a clear onset (not long-term); is not the result of continuous exertion; cannot be relieved after rest; and leads to a significant decline in work, education, social or personal activity levels compared to before. (2) Four or more of the following symptoms occur simultaneously and have persisted or occurred for 6 months or longer, but should not occur earlier than fatigue: ① a significant decrease in short-term memory or concentration; ② sore throat; ③ swollen and tender lymph nodes in the neck or armpits; ④ muscle pain; ⑤ pain in multiple joints without redness or swelling; ⑥ a new type of severe headache; ⑦ inability to sleep to relieve fatigue; ⑧ fatigue after exercise lasting more than 24 hours.

[0070] The subjects scored the degree of improvement in fatigue and throat discomfort based on their personal sensory experience, with a maximum score of 10. The higher the score, the better the improvement effect, and 0 means no improvement. The average score and the comprehensive score of each item were calculated based on the scores of each subject. Before the start of the experiment, the subjects first selected the flavor preference of the samples processed by the two different processes, and the selection results were counted.

[0071] The results of the flavor test are as follows Figure 2 As shown, 78% of the subjects believed that the flavor of process 2 (adding maltitol liquid) was better, indicating that the improved process was more easily accepted by the public.

[0072] The therapeutic effects of Chinese medicine preparations are shown in Table 1:

[0073] Table 1

[0074] Chinese medicine preparations Improve fatigue Improve sore throat Comprehensive score Example 1 7.8 5.3 13.1 Example 2 7.3 5.5 12.8 Example 3 6.7 5.6 12.3 Comparative Example 1 7.6 1.7 9.3 Comparative Example 2 3 4.8 7.8 Comparative Example 3 5.7 4.9 10.6 Comparative Example 4 7.6 5 12.6

[0075] The comprehensive score of the Chinese medicine preparation of Example 1 is 13.1 points; the comprehensive score of Example 2 is 12.8 points; the comprehensive score of Example 3 is 12.3 points; the comprehensive score of Comparative Example 1 is 9.3 points; the comprehensive score of Comparative Example 2 is 7.8 points; the comprehensive score of Comparative Example 3 is 10.6 points; the comprehensive score of Comparative Example 4 is 12.6 points. Among them, the addition of Momordica grosvenori and loquat leaves in Examples 2 and 3 will affect the therapeutic effect of relieving fatigue, Comparative Examples 1 and 2 show that American ginseng and Citrus aurantium can synergistically treat fatigue and throat discomfort, and Comparative Examples 3 and 4 show that the therapeutic effect of unreasonable ratios for treating fatigue and throat discomfort is general. In summary, Example 1 has the highest comprehensive score and the best effect. The subjects all believe that Example 1 can improve the symptoms of throat discomfort and easy fatigue to varying degrees. Due to individual differences, the improvement effect is slightly different.

[0076] The above embodiments are preferred implementation modes of the present invention, but the implementation modes of the present invention are not limited to the above embodiments. Any other changes, modifications, substitutions, combinations, and simplifications that do not deviate from the spirit and principles of the present invention should be equivalent replacement methods and are included in the protection scope of the present invention.

Claims

1. A Chinese medicine composition, characterized in that: The invention comprises the following raw materials in parts by weight: 30-50 parts of American ginseng and 1 part of Citrus aurantium embryo.

2. The Chinese medicine composition according to claim 1, characterized in that: The invention is prepared from the following raw materials in parts by weight: 35-45 parts of American ginseng and 1 part of Citrus aurantium embryo.

3. The Chinese medicine composition according to claim 1, characterized in that The Chinese medicine composition is a water extract obtained by mixing various raw materials, or the sum of water extracts extracted separately.

4. The method for preparing the Chinese medicine composition according to any one of claims 1 to 3, characterized in that: The method comprises the following steps: mixing American ginseng and Citrus aurantium embryo, and then extracting with water once or multiple times to obtain a Chinese medicine composition extract.

5. The method for preparing the Chinese medicine composition according to claim 4, characterized in that: The water extraction process comprises: performing a first water extraction at 55-65°C, performing a second water extraction at 55-65°C, and performing a third water extraction at 95-100°C.

6. A pharmaceutical composition, characterized in that The pharmaceutical composition is prepared from the traditional Chinese medicine composition according to any one of claims 1 to 3 and a pharmaceutically acceptable carrier.

7. The pharmaceutical composition according to claim 6, characterized in that The dosage form of the pharmaceutical composition is selected from one of ointment, syrup, pill, capsule, granule, oral liquid, powder, tablet, lozenge and sugar lozenge.

8. The method for preparing the Chinese medicine composition according to claim 6, characterized in that: The raw materials of the syrup include the water extract of the mixed raw materials as claimed in claim 3 or the sum of the water extracts extracted separately, and a sweetener.

9. Use of the Chinese medicine composition according to any one of claims 1 to 3, or the pharmaceutical composition according to any one of claims 6 to 8, in the preparation of a medicament for preventing or treating symptoms of fatigue and throat discomfort.

10. The use according to claim 9, characterized in that: The application of the traditional Chinese medicine composition or the pharmaceutical composition in preparing a medicine for preventing or treating fatigue and throat discomfort symptoms caused by staying up late.

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