TWI825996B - Compositions for treating diseases and/or symptoms caused by the new coronavirus - Google Patents
Compositions for treating diseases and/or symptoms caused by the new coronavirus Download PDFInfo
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Abstract
本發明係提供一種用於治療新冠病毒引起之疾病及/或病徵之組合物，意即藉由投予本發明所揭組合物至一罹患新冠病毒引起之疾病或病徵之患者，係能夠於確診後之短時間內達到有效改善或治療新冠病毒引起之疾病或其引起之相關病徵之功效。The present invention provides a composition for treating diseases and/or symptoms caused by the new coronavirus, which means that by administering the composition disclosed in the present invention to a patient suffering from the disease or symptoms caused by the new coronavirus, the diagnosis can be made Effectively improve or treat the disease caused by the new coronavirus or the related symptoms caused by it within a short period of time.
Description
本發明係有關於一種醫藥組合物及其用途，特別係指一種用於治療新冠病毒引起之疾病及/或病徵之組合物。The present invention relates to a pharmaceutical composition and its use, particularly a composition for treating diseases and/or symptoms caused by the new coronavirus.
按，COVID-19（下稱新冠肺炎）自2019年底爆發以來，於全世界各國都造成嚴重之疫情，使超過三千萬人感疫，並且隨著病毒突變，讓各國之防疫工作更加困難。罹患新冠肺炎主要會出現發燒、乾咳、疲勞、有痰、呼吸急促、肌肉或關節痠痛、喉嚨痛、頭痛等症狀，並且依據患者身體狀況之不同，即使康復後仍會對於申請身體上產生不同之後遺症。Since the outbreak of COVID-19 (hereinafter referred to as COVID-19) at the end of 2019, it has caused serious epidemics in countries around the world, infecting more than 30 million people. As the virus mutates, it has made epidemic prevention work in various countries more difficult. The main symptoms of COVID-19 are fever, dry cough, fatigue, phlegm, shortness of breath, muscle or joint aches, sore throat, headache, etc. Depending on the patient's physical condition, even after recovery, there will still be different physical symptoms. sequelae.
目前台灣臨床上治療新冠肺炎之藥物包含有Paxlovid、莫納皮拉韋、清冠一號等，但該些藥物除了取得困難外，並於使用上都有其缺點所在，例如Paxlovid會與抗心律不整藥物、降血脂藥物等產生不良反應；莫納皮拉韋會有腹瀉或噁心等副作用，並且孕婦無法服用；清冠一號雖然相較於上述西藥之副作用較少，但是未正確使用仍會產生腹瀉、免疫力失調之情形。而除了上述經台灣主管機關核准上市之藥物外，市面上亦出現大量訴求可治療或改善新冠肺炎症狀之偏方或保健食品，然而絕大多數產品並未提供相關實證，不僅無法確認實際治療效果，更有對身體健康造成不良影響之疑慮存在。Currently, the drugs clinically used to treat COVID-19 in Taiwan include Paxlovid, Monapiravir, Qingguan No. 1, etc. However, in addition to being difficult to obtain, these drugs also have their own shortcomings in use. For example, Paxlovid can interact with anti-arrhythmia drugs. Unhealthy drugs and anti-hyperlipidemic drugs may cause adverse reactions; Monapiravir may have side effects such as diarrhea or nausea, and pregnant women cannot take it; although Qingguan No. 1 has fewer side effects than the above-mentioned Western medicines, it may still occur if not used correctly. Diarrhea and immune disorders may occur. In addition to the above-mentioned drugs approved by the Taiwanese regulatory authorities, there are also a large number of folk remedies or health foods on the market that claim to be able to treat or improve the symptoms of COVID-19. However, most of the products do not provide relevant evidence, and not only cannot the actual therapeutic effect be confirmed, There are also concerns about adverse effects on physical health.
本發明之主要目的係在於提供一種用於治療新冠病毒引起之疾病及/其相或關病徵之組合物，其係含有一有效量之植物萃取物作為活性成分，並該植物萃取物係來自油甘與積雪草，而藉由投予該組合物或是將之與臨床藥物併用，係能夠於短時間內有效地改善或減緩因感染新型冠狀病毒所引起之病症，以達到治療或輔助治療新冠肺炎且降低新冠肺炎進展為中重症之功效。The main purpose of the present invention is to provide a composition for treating diseases caused by the new coronavirus and/or related symptoms, which contains an effective amount of plant extracts as active ingredients, and the plant extracts are derived from oil. Gan and Centella asiatica, and by administering the composition or using it in combination with clinical drugs, it can effectively improve or slow down the symptoms caused by infection with the new coronavirus in a short period of time, so as to achieve the treatment or auxiliary treatment of the new coronavirus. pneumonia and reduce the progression of COVID-19 to moderate to severe disease.
本發明之另一目的係在於提供一種用於治療新冠病毒引起之疾病及/其相或關病徵之組合物，由於其活性成份為植物萃取物，故不會對人體產生副作用。Another object of the present invention is to provide a composition for treating diseases caused by the new coronavirus and/or related symptoms. Since its active ingredient is a plant extract, it will not cause side effects on the human body.
是以，為能達成上述目的，本發明係提供一種用於治療新冠病毒引起之疾病及/其相或關病徵之組合物，其係包含有一有效量之油甘萃取物及一有效量之積雪草萃取物，能夠用於改善或減緩因新冠病毒感染所引發之病症，以達到縮短治療時程或是降低疾病惡化風險之功效。Therefore, in order to achieve the above object, the present invention provides a composition for treating diseases caused by the new coronavirus and/or related symptoms, which contains an effective amount of glycerin extract and an effective amount of asiatica. Grass extract can be used to improve or slow down the symptoms caused by the new coronavirus infection, so as to shorten the treatment period or reduce the risk of disease progression.
其中，該油甘萃取物係由油甘的果實萃取而得者，具體來說，將油甘的果實以重量百分濃度1%之氯化鈉水溶液作為萃取溶劑，於65℃至75℃下進行萃取後，依序進行過濾及乾燥程序，得到呈棕色之油甘萃取物。Among them, the glycerin extract is obtained from the fruit of glycerin. Specifically, the glycerin fruit is extracted with a sodium chloride aqueous solution with a concentration of 1% by weight as the extraction solvent at 65°C to 75°C. After extraction, filtering and drying procedures are performed sequentially to obtain a brown glycerin extract.
其中，該積雪草萃取物係由積雪草進行萃取程序所得者，具體來說，將積雪草破碎物以純水作為萃取溶劑，於65℃至75℃下進行加熱濃縮、過濾及冷凍乾燥程序，得到積雪草萃取物。Among them, the Centella asiatica extract is obtained by an extraction process of Centella asiatica. Specifically, the Centella asiatica crushing product is heated and concentrated, filtered and freeze-dried at 65°C to 75°C using pure water as the extraction solvent. Centella asiatica extract was obtained.
其中，該新冠病毒引起之病徵係包含有發燒、體力不足、疲勞、反應力不佳、健忘、喉嚨疼痛、咳嗽有痰、流鼻水、喘、呼吸困難、胸悶、胸痛、頭暈、頭脹、頭疼噁心想吐、無食慾、拉肚子、腹痛等。Among them, the symptoms caused by the new coronavirus include fever, lack of physical strength, fatigue, poor reflexes, forgetfulness, sore throat, cough with phlegm, runny nose, wheezing, difficulty breathing, chest tightness, chest pain, dizziness, head fullness, and headache. Nausea, loss of appetite, diarrhea, abdominal pain, etc.
於本發明之實施例中，該組合物中係含有一預定重量比之該油甘萃取物及該積雪草萃取物，如該組合物中係含有重量比為1：1之該油甘萃取物及該積雪草萃取物。In embodiments of the present invention, the composition contains a predetermined weight ratio of the glycerin extract and the Centella asiatica extract. For example, the composition contains the glycerin extract in a weight ratio of 1:1. and the Centella asiatica extract.
於本發明之一實施例中，該組合物係由該油甘萃取物及該積雪草萃取物所組成。In one embodiment of the present invention, the composition is composed of the glycerin extract and the Centella asiatica extract.
於本發明之實施例中，該組合物係被製備為一食品、一營養補充品、醫藥品或一輔療品，並且可依據需求而被製備為不同劑型，如粉劑、錠劑、懸浮液等。In embodiments of the present invention, the composition is prepared as a food, a nutritional supplement, a pharmaceutical or an auxiliary therapy, and can be prepared in different dosage forms according to needs, such as powders, lozenges, and suspensions. wait.
本發明係揭露一種用於治療新冠病毒引起之疾病及/或病徵之組合物，其係包含有一有效量之油甘萃取物及有一有效量之積雪草萃取物。由於該油甘萃取物及該積雪草萃取物係對於新冠病毒引起之病症有改善或舒緩之能力，故投予本發明所揭組合物至一罹患新冠肺炎或受新冠病毒感染之患者，不論該患者是否有採用其他治療方法，如投予Paxlovid、莫納皮拉韋、清冠一號等，都能夠於確診後之短時間內達到有效改善或治療新冠病毒引起之疾病或病徵之功效。The present invention discloses a composition for treating diseases and/or symptoms caused by the new coronavirus, which contains an effective amount of glycerin extract and an effective amount of Centella asiatica extract. Since the glycerin extract and the Centella asiatica extract have the ability to improve or relieve the symptoms caused by the new coronavirus, the composition disclosed in the present invention is administered to a patient suffering from new coronavirus pneumonia or infected by the new coronavirus, regardless of whether the patient is suffering from new coronavirus pneumonia or infected with the new coronavirus. Whether the patient has taken other treatment methods, such as Paxlovid, Monapiravir, Qingguan No. 1, etc., they can effectively improve or treat the disease or symptoms caused by the new coronavirus within a short period of time after diagnosis.
本發明所揭「油甘（Phyllanthus Emblica或Emblica Officinale）」，又稱餘甘子、余甘子、庵摩勒（Amalaka）、馬六甲樹（Pokok Melaka）、印度醋栗（Indian Gooseberry），屬於大戟科餘甘子屬之落葉亞喬木，分佈於自印度至馬來西亞地區及中國南部，一般認為印度為原產地。The "Phyllanthus Emblica or Emblica Officinale" disclosed in the present invention is also known as Phyllanthus emblica, Phyllanthus emblica, Amalaka, Pokok Melaka, and Indian Gooseberry, and belongs to the Euphorbiaceae family. A deciduous sub-arbor of the genus Amla, distributed from India to Malaysia and southern China. India is generally considered to be its origin.
本發明所揭「油甘萃取物」，係指至少含有重量百分比3%以上之沒子酸及鞣花酸之混合物，其係由油甘或與其具有不同學名但具有相似成份之植物進行於65℃至75℃之環境下進行萃取所得者。乾燥後的油甘萃取物型態為棕色粉末（Brown powder）。The "glycerin extract" disclosed in the present invention refers to a mixture containing at least 3% by weight of gallic acid and ellagic acid, which is obtained from glycerin or plants with different scientific names but similar ingredients. It is extracted under an environment of ℃ to 75℃. The dried glycerin extract is in the form of brown powder.
於本發明所揭實驗例中所使用之油甘萃取物係以下列方式製備而成者：將油甘（Emblica Officinalis）的果實浸於重量百分濃度1%之氯化鈉水溶液，將含有果實的水溶液再以65℃至75℃的蒸汽壓力鍋加熱萃取1小時，接著進行離心過濾將過濾後萃取液繼續萃取至膏狀體後送入冷凍乾燥，最後冷凍乾燥後的油甘片接著透過磨粉整粒程序得到油甘萃取物粉末。此油甘萃取物型態為棕色粉末。The glycerin extract used in the experimental examples disclosed in the present invention is prepared in the following manner: immerse the fruits of Emblica Officinalis in a sodium chloride aqueous solution with a concentration of 1% by weight. The aqueous solution is then heated and extracted in a steam pressure cooker at 65°C to 75°C for 1 hour, followed by centrifugal filtration. The filtered extract is continued to be extracted into a paste and then sent to freeze-drying. Finally, the freeze-dried glycerin flakes are then ground into powder. The glycerin extract powder was obtained through the granulation procedure. This glycerin extract is in the form of brown powder.
本發明所揭「積雪草（Centella asiatica）」，又名雷公根、落得打、崩大碗、蚶殼草，係為一種繖形科積雪草屬之多年生植物，生於田邊、溝邊低濕處，原產於斯里蘭卡、印度等地，現廣泛分布於亞洲熱帶、亞熱帶地區，亦是中國中部、南部、香港以至日本、韓國及台灣的常見植物。The "Centella asiatica" disclosed in the present invention, also known as Centella asiatica, Centella asiatica, Centella asiatica, is a perennial plant of the genus Centella asiatica in the family Umbelliferae. It grows in low humidity on the edges of fields and ditches. It is native to Sri Lanka, India and other places, and is now widely distributed in tropical and subtropical areas of Asia. It is also a common plant in central and southern China, Hong Kong, and even Japan, South Korea and Taiwan.
本發明所揭「積雪草萃取物」，係主要含有如五環三萜皂苷（triterpenoids）之五環三萜類化合物，包括積雪草苷（asiaticoside）、羥基積雪草苷（madecassoside）等，而該積雪草萃取物係將積雪草進行於65℃至75℃之環境下進行萃取及濃縮所得者。乾燥後之積雪草萃取物型態為棕色粉末。The "Centella asiatica extract" disclosed in the present invention mainly contains pentacyclic triterpenoids such as triterpenoids, including madecassoside (asiaticoside), madecassoside (madecassoside), etc., and the Centella asiatica extract is obtained by extracting and concentrating Centella asiatica in an environment of 65°C to 75°C. After drying, Centella asiatica extract is in the form of brown powder.
於本發明所揭實驗例中所使用之積雪草萃取物係以下列方式製備而成者：將濕的積雪草打碎浸於純水中，再以65℃至75℃的（Brown powder)加熱濃縮至10:1濃度比例後，並進行離心過濾，並取濃縮液再冷凍3天，將冷乾的積雪草片藉由磨粉整粒程序得到積雪草萃取物粉末。The Centella asiatica extract used in the experimental examples disclosed in the present invention is prepared in the following manner: wet Centella asiatica is crushed and soaked in pure water, and then heated with (Brown powder) at 65°C to 75°C After concentration to a concentration ratio of 10:1, centrifugal filtration is performed, and the concentrated liquid is frozen for another 3 days. The freeze-dried Centella asiatica slices are ground and granulated to obtain Centella asiatica extract powder.
本發明所揭「組合物」，係指至少含有一有效量之活性成分，對於人體健康之維持或病症之改善有一定幫助者，如一藥品、一營養補充品、一輔療品，並得依據需求另外添加一食品上能接受載體或一醫藥上所接受之載劑。The "composition" disclosed in the present invention refers to one that contains at least an effective amount of active ingredients, which is helpful to the maintenance of human health or the improvement of diseases, such as a medicine, a nutritional supplement, and a auxiliary therapy, and can be based on It is necessary to add a food-acceptable carrier or a pharmaceutically-acceptable carrier.
以本發明之實施例來說，該活性成分係包含有油甘萃取物及積雪草萃取物，並該油甘萃取物及該積雪草萃取物之總量係佔該組合物全部之1％-100％，並該油甘萃取物及該積雪草萃取物之組成比例係得依據本發明所屬技術領域之通常知識予以調整，例如該油甘萃取物及該積雪草萃取物之重量比約為1：1、1:2、2：1、3：2、1：4等，其中，前述比例中之「約」代表涵蓋本發明所屬技術領域能夠接受之正負誤差值，例如因調製環境、測量儀器所造成之誤差。In the embodiment of the present invention, the active ingredient includes glycerin extract and Centella asiatica extract, and the total amount of the glycerin extract and Centella asiatica extract accounts for 1% of the entire composition - 100%, and the composition ratio of the glycerin extract and the Centella asiatica extract can be adjusted based on common knowledge in the technical field of the present invention. For example, the weight ratio of the glycerin extract and the Centella asiatica extract is about 1 : 1, 1:2, 2:1, 3:2, 1:4, etc., where the "approximately" in the aforementioned ratio represents the acceptable positive and negative error values covering the technical field to which the present invention belongs, such as due to the modulation environment and measuring instruments. errors caused.
本發明所指「治療」，係指一種解決或改善健康問題之手段，得直接且單一施用於生物體上、或是得與其他臨床藥物或手段同時或先後施用於生物體上，例如輔助治療。"Treatment" as referred to in the present invention refers to a means to solve or improve health problems, which can be directly and solely applied to an organism, or can be applied to an organism simultaneously or successively with other clinical drugs or means, such as auxiliary treatment. .
本發明所指「有效量」，係指能於所投予之生物體上發揮其活性之劑量。The "effective dose" referred to in the present invention refers to the dose that can exert its activity on the organism to which it is administered.
本發明所指「新冠病毒」，又被稱為新型冠狀病毒（SARS-CoV-2），其屬於冠狀病毒科（Coronavirinae）之beta亞科（betacoronavirus），研究指出目前新冠病毒具有多種變異株，包含有Alpha（又稱B.1.1.7）、Omicron（又稱B.1.1.529）、Delta（又稱B.1.617.2）。The "new coronavirus" referred to in the present invention is also known as the new coronavirus (SARS-CoV-2), which belongs to the beta subfamily (betacoronavirus) of the Coronavirinae family. Research has pointed out that the new coronavirus currently has multiple mutant strains. Includes Alpha (also known as B.1.1.7), Omicron (also known as B.1.1.529), and Delta (also known as B.1.617.2).
本發明所指「新冠肺炎」，又稱為嚴重特殊傳染性肺炎（COVID-19），係由新型冠狀病毒（SARS-CoV-2）或其變異株所感染所引起者。。The "new coronavirus pneumonia" referred to in this invention, also known as severe special infectious pneumonia (COVID-19), is caused by infection with the new coronavirus (SARS-CoV-2) or its mutant strains. .
本發明所指「輔療品」，係指能夠與臨床用藥並用，並具有提升臨床用藥之療效、縮短治療時間、降低臨床藥物使用劑量、降低或減緩患者之不適感或降低臨床藥物副作用發生之機會等功效之組合物。舉例來說，該輔療品係包含有油甘萃取物及積雪草萃取物，或是由重量比為1：1之油甘萃取物及積雪草萃取物所組成者。"Adjuvant therapeutic products" as referred to in the present invention refer to products that can be used together with clinical drugs and have the ability to improve the efficacy of clinical drugs, shorten treatment time, reduce the dosage of clinical drugs, reduce or alleviate the discomfort of patients, or reduce the occurrence of clinical drug side effects. Opportunity and other effects of the composition. For example, the adjuvant treatment system contains glycerin extract and Centella asiatica extract, or is composed of glycerin extract and Centella asiatica extract in a weight ratio of 1:1.
以下，為能說明本發明之技術特徵及其功效，將茲舉若干實驗例並搭配圖式做詳細說明如後。In the following, in order to illustrate the technical features and effects of the present invention, several experimental examples will be given and explained in detail with drawings.
實例一：人體試驗（一）Example 1: Human Experiment (1)
於本實例中募集共20位新冠肺炎確診者作為受試者，該些受試者之年齡於25-70歲之間，隨機分為兩組，分別於確診快篩陽性期間10天以下列條件處理之：In this example, a total of 20 people diagnosed with COVID-19 were recruited as subjects. The subjects were aged between 25-70 years old and were randomly divided into two groups. They were subject to the following conditions within 10 days of the confirmed rapid screening period. Process it:
控制組：於確診期間未投予任何保健食品；Control group: no health food was given during the diagnosis period;
實驗組：於確診時間投予本發明所揭組合物，每日三次，每次500mg；Experimental group: Administer the composition disclosed in the present invention at the time of diagnosis, three times a day, 500 mg each time;
其中，本發明所揭組合物係含有250mg油甘萃取物與250mg積雪草萃取物，而油甘萃取物係由油甘的果實以氯化鈉水溶液（1 wt%）作為萃取溶劑於65℃至75℃下進行依序萃取、過濾、冷凍乾燥等程序所得者，經分析，該油甘萃取物至少含有重量百分比3%以上之沒子酸及鞣花酸之混合物；積雪草萃取物係由將積雪草破碎物以純水作為萃取溶劑，於65℃至75℃下進行加熱濃縮、過濾及冷凍乾燥程序所得者，經分析，該積雪草萃取物係主要包含有五環三萜皂苷（triterpenoids），如積雪草苷（asiaticoside）、羥基積雪草苷（madecassoside）等。Among them, the composition disclosed in the present invention contains 250 mg of glycerin extract and 250 mg of centella asiatica extract, and the glycerin extract is made from the fruit of glycerin using sodium chloride aqueous solution (1 wt%) as the extraction solvent at 65°C to Obtained by sequential extraction, filtration, freeze-drying and other procedures at 75°C, after analysis, the glycerin extract contains at least 3% by weight of a mixture of gallic acid and ellagic acid; Centella asiatica extract is made from The crushed Centella asiatica extract uses pure water as the extraction solvent, and is heated, concentrated, filtered and freeze-dried at 65°C to 75°C. After analysis, the Centella asiatica extract mainly contains pentacyclic triterpenoid saponins (triterpenoids). , such as madecassoside (asiaticoside), madecassoside (madecassoside), etc.
於試驗期間，各組受試者每日紀錄所測得之體溫、填寫精神（疲勞度）體感評估量表，及填寫針對上呼吸道症狀、肺部呼吸症狀、腦部不適症狀、肌肉關節酸痛及疼痛症狀、腸胃道不適症狀等五大症狀體感評估量表；其中，上述各量表係以1-5分之分數表現，於精神（疲勞度）體感評估量表所評估之症狀包含體力不足、疲勞度、反應力及健忘，分數為1分時代表示最嚴重精神症狀，分數為5分時代表無任何症狀；於五大症狀體感評估量表中，分數為1分時代表示無症狀，分數為5分時代表症狀最嚴重，而上呼吸道症狀包含有喉嚨疼痛、咳嗽有痰、流鼻水，肺部呼吸症狀包含有喘、呼吸困難、胸悶、胸痛，腦部不適症狀包含有頭暈、頭脹、頭疼，腸胃道不適症狀包含有噁心想吐、無食慾、拉肚子及腹痛。During the trial, subjects in each group recorded the measured body temperature, filled in the mental (fatigue) somatosensory assessment scale, and filled in the upper respiratory tract symptoms, pulmonary respiratory symptoms, brain discomfort symptoms, and muscle and joint soreness every day. and five major symptom somatosensory assessment scales, including pain symptoms and gastrointestinal discomfort symptoms. Among them, each of the above scales is expressed with a score of 1-5. The symptoms evaluated in the mental (fatigue) somatosensory assessment scale include physical strength. Insufficiency, fatigue, responsiveness and forgetfulness, a score of 1 indicates the most severe mental symptoms, and a score of 5 indicates no symptoms; in the five major symptom somatosensory assessment scale, a score of 1 indicates no symptoms. A score of 5 represents the most severe symptoms, and upper respiratory symptoms include sore throat, cough with phlegm, and runny nose; pulmonary respiratory symptoms include wheezing, dyspnea, chest tightness, and chest pain; and brain discomfort symptoms include dizziness and headache. Bloating, headache, and gastrointestinal discomfort symptoms include nausea, loss of appetite, diarrhea, and abdominal pain.
各組受試者於試驗期間所填寫之各量表經統計分析後之結果如圖1至圖7所示。由圖1至圖7之結果可知，相較於控制組來說，本發明所揭含有油甘與積雪草之組合物係能夠於投予1天後開始對於體溫、精神、上呼吸道症狀、肺部呼吸症狀、腦部不適症狀、肌肉關節酸動及疼痛症狀有改善，並且隨著投予時間增加，改善效果越佳。 The results of statistical analysis of each scale filled in by subjects in each group during the trial are shown in Figures 1 to 7. It can be seen from the results of Figures 1 to 7 that, compared with the control group, the composition containing glycerin and centella asiatica disclosed by the present invention can start to improve body temperature, mental state, upper respiratory tract symptoms, and pulmonary symptoms 1 day after administration. The symptoms of respiratory symptoms, brain discomfort, muscle and joint soreness and pain are improved, and the improvement effect becomes better as the time of administration increases.
具體來說：投予1天含有油甘與積雪草之組合物係能夠大幅降低肺部呼吸不適感，進而能夠預防或避免肺部發炎或呼吸道病症，如哮喘等發生；投予3天含有油甘與積雪草之組合物係能夠使平均體溫降低至37.2度，以減緩身體發炎或是併發症之發生。相較於實驗組，投予3天含有油甘與積雪草之組合物係對於呼吸道不適症狀之改善效果約為降低45%；對於快速減輕頭暈、頭疼等腦部不適症狀之改善效果為降低13%。於投予1天及4天含有油甘與積雪草之組合物後，實驗組相較於控制組係能夠有效降低肌肉關節酸痛及疼痛之症狀，改善率約33%，顯示本發明所揭含有油甘與積雪草之組合物不僅能夠快速且持續緩解肌肉關節疼痛之症狀，更能有效地減緩肌肉及關節發炎及耗損情形之發生。於投予10天含有油甘與積雪草之組合物後，相較於控制組來說，實驗組對於精神不適症狀明顯有改善，改善率約為35%。 Specifically: administration of a composition containing glycerin and centella asiatica for one day can significantly reduce respiratory discomfort in the lungs, thereby preventing or avoiding lung inflammation or respiratory diseases, such as asthma; administration for three days of a composition containing oil The combination of sweet and centella asiatica can lower the average body temperature to 37.2 degrees to slow down the occurrence of inflammation or complications in the body. Compared with the experimental group, the improvement effect of the composition containing glycerin and centella asiatica for 3 days on respiratory discomfort symptoms was reduced by approximately 45%; the improvement effect on the rapid relief of dizziness, headache and other brain discomfort symptoms was reduced by 13% %. After administration of the composition containing glycerin and centella asiatica for 1 and 4 days, the experimental group was able to effectively reduce the symptoms of muscle and joint soreness and pain compared with the control group, with an improvement rate of approximately 33%, showing that the composition disclosed by the present invention contains The combination of glycerin and centella asiatica can not only quickly and continuously relieve the symptoms of muscle and joint pain, but also effectively slow down the inflammation and wear and tear of muscles and joints. After 10 days of administration of the composition containing glycerin and centella asiatica, the experimental group had a significant improvement in symptoms of mental discomfort compared with the control group, with an improvement rate of approximately 35%.
實例二：人體試驗(二) Example 2: Human experiment (2)
於本實例中募集共15位新冠肺炎確診者作為受試者，該些受試者之年齡於25-70歲之間，隨機分為三組(每組5人)，分別於確診快篩陽性期間1-4天以下列條件處理之：控制組：於確診期間未投予任何保健食品或藥品； In this example, a total of 15 people diagnosed with COVID-19 were recruited as subjects. These subjects were aged between 25-70 years old and were randomly divided into three groups (5 people in each group). The patients were treated under the following conditions for 1-4 days during the period: Control group: no health food or medicine was given during the diagnosis period;
藥品組：於確診期間有服用藥物，如新冠一號或具相同配方之中藥、感冒藥、抗病毒藥物；Drug group: those who took drugs during the period of diagnosis, such as COVID-19 or Chinese medicines with the same formula, cold medicines, and antiviral drugs;
實驗組：於確診期間有服用藥物，如新冠一號或具相同配方之中藥、感冒藥、抗病毒藥物，並搭配本發明所揭組合物，其中，本發明所揭組合物之劑量為每日三次，每次500mg，而該組合物之組成與製備方式如實例一中所述，故於此不加以贅述。Experimental group: During the period of diagnosis, people took medicines, such as COVID-19 or Chinese medicines, cold medicines, and antiviral medicines with the same formula, and combined with the composition disclosed in the present invention, wherein the dosage of the composition disclosed in the present invention is daily Three times, 500 mg each time. The composition and preparation method of the composition are as described in Example 1, so they will not be described again here.
如同實例一所說明者，各組受試者於試驗期間需填寫體溫、填寫精神（疲勞度）體感評估量表及五大症狀體感評估量表，並將各組受試者所填寫之各量表進行統計分析，結果如圖8至圖14所示。As explained in Example 1, subjects in each group are required to fill in their body temperature, mental (fatigue) and somatosensory assessment scale and five major symptom somatosensory assessment scale during the trial period, and the subjects in each group should fill in each form. Statistical analysis was performed on the scale, and the results are shown in Figures 8 to 14.
由圖8至圖14之結果可知，相較於控制組來說，投予藥物之藥品組患者或投予藥物及本發明所揭組合物之實驗組患者都能於確診1-4天內有效地舒緩或改善新冠肺炎之病症；並且，投予藥品及本發明所揭組合物之實驗組之改善效果係明顯優於僅投予藥物之藥品組患者；由此顯示，本發明所揭組合物確實能夠作為輔療品，有效地達到輔助藥物於體內發揮治療新冠肺炎或其相關病徵之功效，進而能夠縮短治療時程、減緩患者之不適感。It can be seen from the results of Figure 8 to Figure 14 that compared with the control group, patients in the pharmaceutical group who were administered drugs or patients in the experimental group who were administered drugs and the composition disclosed in the present invention were all effective within 1-4 days of diagnosis. It can effectively relieve or improve the symptoms of new coronary pneumonia; and the improvement effect of the experimental group administered with drugs and the composition disclosed in the present invention is significantly better than that of the patients in the pharmaceutical group only administered drugs; this shows that the composition disclosed in the present invention It can indeed be used as an auxiliary therapy to effectively achieve the effect of auxiliary drugs in the treatment of COVID-19 or its related symptoms in the body, thereby shortening the treatment period and alleviating the patient's discomfort.
具體來說，如圖8所示，實驗組患者相較於藥品組患者來說，於確診3天後之體溫已經降至正常體溫，平均約為36.7℃，顯示實驗組患者體內發炎情形已經被舒緩；由圖9之結果可知，本發明所揭組合物係能輔助藥物發揮改善體力不足、疲勞、反應力下降及健忘之病症，改善情形較藥品組提升32％；由圖10之結果可知，本發明所揭組合物係能輔助提升藥物改善或舒緩上呼吸道之症狀，如喉嚨疼痛、有痰、流鼻水等，並實驗組改善或舒緩上呼吸道症狀係較藥品組提升29％；由圖11之結果可知本發明所揭組合物及藥物併用係能快速降低確診者之疼痛感，改善效果較藥物組提升約為58％，意即本發明所揭組合物係能夠有效輔助藥物舒緩或改善確診者之肌肉及關節發炎及耗損之情形；由圖12之結果可知本發明所揭組合物係能輔助藥物於體內發揮舒緩肺部呼吸之不適感，如胸悶、胸痛、呼吸困難、氣喘等，意即本發明所揭組合物與藥物併用確實有效地達到提升預防或避免因新冠病毒感染而造成之肺部症狀惡化的功效；由圖13之結果可知本發明所揭組合物與藥物併用對於腦部不適之改善效果較單獨投予藥物者提升52％，顯示本發明所揭組合物確實具有輔助藥物治療或舒緩因新冠病毒所引發之腦部不適的功效；由圖14之結果可知，併用本發明所揭組合物與藥物相較於單獨服用藥物之受試者來說，其腸胃道不適之症狀能夠大幅被改善，此功效對於目前臨床用於新冠肺炎之治療十分重要，尤其是治療新冠肺炎之藥物多存在著會造成腸胃道不適之副作用，例如清冠一號會造成腹瀉，因此透過併用本發明所揭組合物不僅能夠提升藥物之療效，更能減輕藥物之副作用。Specifically, as shown in Figure 8, compared with patients in the drug group, the body temperature of patients in the experimental group has dropped to normal body temperature 3 days after diagnosis, with an average of approximately 36.7°C, indicating that the inflammation in the patients in the experimental group has been eliminated. Soothing; from the results in Figure 9, it can be seen that the composition disclosed in the present invention can assist the medicine to improve the symptoms of lack of physical strength, fatigue, decreased reaction ability and forgetfulness, and the improvement is 32% higher than that of the medicine group; from the results in Figure 10, it can be seen that, The composition disclosed in the present invention can assist in improving or relieving the symptoms of the upper respiratory tract, such as sore throat, phlegm, runny nose, etc., and the experimental group improves or relieves the symptoms of the upper respiratory tract by 29% compared with the drug group; from Figure 11 The results show that the combination of the composition disclosed in the present invention and drugs can quickly reduce the pain of diagnosed patients, and the improvement effect is about 58% higher than that of the drug group, which means that the composition disclosed in the present invention can effectively assist drugs in soothing or improving diagnosis. The patient's muscles and joints are inflamed and worn out; from the results in Figure 12, it can be seen that the composition disclosed in the present invention can assist the medicine in the body to relieve discomfort caused by lung breathing, such as chest tightness, chest pain, dyspnea, asthma, etc., meaning That is to say, the combined use of the composition disclosed in the present invention and drugs can indeed effectively improve the effect of preventing or avoiding the worsening of pulmonary symptoms caused by the new coronavirus infection; from the results in Figure 13, it can be seen that the combined use of the composition disclosed in the present invention and drugs has an effect on the brain. The improvement effect of discomfort is 52% higher than that of the drug alone, which shows that the composition disclosed in the present invention does have the effect of auxiliary drug treatment or soothing the brain discomfort caused by the new coronavirus; as can be seen from the results in Figure 14, combined with the use of the present invention Compared with subjects taking the drug alone, the disclosed compositions and drugs can significantly improve the symptoms of gastrointestinal discomfort. This effect is very important for the current clinical use in the treatment of COVID-19, especially in the treatment of COVID-19. Many drugs have side effects that can cause gastrointestinal discomfort. For example, Qingguan No. 1 can cause diarrhea. Therefore, the combined use of the composition disclosed in the present invention can not only improve the efficacy of the drugs, but also reduce the side effects of the drugs.
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圖1係為分析人體試驗（一）中各組受試者體溫量表之結果。 圖2係為分析人體試驗（一）中各組受試者精神（疲勞度）體感評估量表之結果。 圖3係為分析人體試驗（一）中各組受試者上呼吸道症狀評估量表之結果。 圖4係為分析人體試驗（一）中各組受試者肌肉關節酸痛及疼痛症狀評估量表之結果。 圖5係為分析人體試驗（一）中各組受試者肺部呼吸症狀評估量表之結果。 圖6係為分析人體試驗（一）中各組受試者腦部不適症狀評估量表之結果。 圖7係為分析人體試驗（一）中各組受試者腸胃道不適症狀評估量表之結果。 圖8係為分析人體試驗（二）中各組受試者體溫量表之結果。 圖9係為分析人體試驗（二）中各組受試者精神（疲勞度）體感評估量表之結果。 圖10係為分析人體試驗（二）中各組受試者上呼吸道症狀評估量表之結果。 圖11係為分析人體試驗（二）中各組受試者肌肉關節酸痛及疼痛症狀評估量表之結果。 圖12係為分析人體試驗（二）中各組受試者肺部呼吸症狀評估量表之結果。 圖13係為分析人體試驗（二）中各組受試者腦部不適症狀評估量表之結果。 圖14係為分析人體試驗（二）中各組受試者腸胃道不適症狀評估量表之結果。 Figure 1 shows the results of analyzing the body temperature scales of each group of subjects in the human experiment (1). Figure 2 is an analysis of the results of the mental (fatigue) somatosensory assessment scale of each group of subjects in the human experiment (1). Figure 3 is an analysis of the results of the upper respiratory tract symptom assessment scale of each group of subjects in the human trial (1). Figure 4 is an analysis of the results of the muscle and joint soreness and pain symptom assessment scales of each group of subjects in the human trial (1). Figure 5 is an analysis of the results of the pulmonary respiratory symptom assessment scale of each group of subjects in the human trial (1). Figure 6 shows the results of analyzing the brain discomfort symptom assessment scale of each group of subjects in the human experiment (1). Figure 7 shows the results of analyzing the gastrointestinal discomfort symptom assessment scale of each group of subjects in the human trial (1). Figure 8 shows the results of analyzing the body temperature scales of each group of subjects in the human experiment (2). Figure 9 is an analysis of the results of the mental (fatigue) somatosensory assessment scale of each group of subjects in the human experiment (2). Figure 10 is an analysis of the results of the upper respiratory tract symptom assessment scale of each group of subjects in the human trial (2). Figure 11 is an analysis of the results of the muscle and joint soreness and pain symptom assessment scales of each group of subjects in the human trial (2). Figure 12 is an analysis of the results of the pulmonary respiratory symptom assessment scale of each group of subjects in the human trial (2). Figure 13 is an analysis of the results of the brain discomfort symptom assessment scale of each group of subjects in the human experiment (2). Figure 14 is an analysis of the results of the gastrointestinal discomfort symptom assessment scale of each group of subjects in the human trial (2).
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Claims (10)
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Citations (3)
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| US6124268A (en) * | 1999-02-17 | 2000-09-26 | Natreon Inc. | Natural antioxidant compositions, method for obtaining same and cosmetic, pharmaceutical and nutritional formulations thereof |
| WO2014081715A1 (en) * | 2012-11-20 | 2014-05-30 | Vita Naturale, Llc | Compositions and methods for their dermatological use |
| WO2021207325A1 (en) * | 2020-04-07 | 2021-10-14 | Sytheon Limited | Natural extract and their components for use in mitigating acute respiratory distress syndrome |
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|---|---|---|---|---|
| US6124268A (en) * | 1999-02-17 | 2000-09-26 | Natreon Inc. | Natural antioxidant compositions, method for obtaining same and cosmetic, pharmaceutical and nutritional formulations thereof |
| WO2014081715A1 (en) * | 2012-11-20 | 2014-05-30 | Vita Naturale, Llc | Compositions and methods for their dermatological use |
| WO2021207325A1 (en) * | 2020-04-07 | 2021-10-14 | Sytheon Limited | Natural extract and their components for use in mitigating acute respiratory distress syndrome |
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| 期刊 Saha S, et.al. Evaluation of Analgesic and Anti-Inflammatory Activity of Chloroform and Methanol Extracts of Centella asiatica Linn. ISRN Pharmacol, 2013:789613, 2013/11/21 * |
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