201201823 六、發明說明： 【發明所屬之技術領域】 本發明屬於中藥技術領域，尤其涉及一種治療由曱型H1N1 專流感病毒引起的流感的中藥及中藥片劑和顆粒劑技術領域。 【先前技術】 流行性感冒（influenza，簡稱流感）是流感病毒引起的急 性呼吸道感染，也是一種傳染性強、傳播速度快的疾病。豆主 要通過空氣中的飛沫、人與人之間的接觸或與被污染物品的接 觸傳播。典型的臨床症狀是··急起高熱、全身疼痛、顯著乏力 和輕度呼吸道症狀。一般秋冬季節是其高發期，所引起的併發 症和死亡現象非常嚴重。 流感病毒可分為曱（A)、乙（B)、丙（C)三型，曱型病毒 經常發生抗原變異’傳染性大，傳播迅速，易發生大範圍流行。 ❹ 甲型腦1流感又稱為A (H1N1)型流感，舊稱人感染豬流 感，曱型H1N1流感病毒是A型流感病毒，攜帶有亞型豬 流感病毒毒株，包含有北美和歐亞豬流感、禽流感和人流感三 種流感病毒的核糖核酸（RNA)基因片斷，同時擁有亞洲豬流 感和非洲豬流感病毒特徵。 甲型麵1、流感臨床表現的早期症狀與普通人流感相似，包 括發熱、咳嗷、喉痛、身體疼痛、頭痛、發熱等，有些還會出 現腹瀉或嘔吐、肌肉痛或疲倦、眼睛發紅等，部分患者病情可 201201823 迅速進展，來勢兇猛、突然高熱、體溫超過39它，甚至繼發嚴 重肺炎、急性呼吸窘迫綜合症、肺出血、胸 '' .,. 積夜、全血細胞 》乂、腎魏衰竭、敗血症、休克及Reye综合症、啤吸衰竭 及多器官損傷’導致壯。患者原有的基礎疾病亦可加重' 目前對流感的患者-般使贱病絲物進行治療，這些藥 物雖然可減輕疾病的嚴重程度並提高生存機會，㈣用過高並 且由於長期使用導致了有些病毒產生耐藥性。 【發明内容】 中醫學上認為流感，為“外邪入侵”，因為病毒發源地不 論是鼻黏膜或呼吸道，都屬臟腑以外，因此稱為“外邪，，。中 醫按病症的表徵和身體反應分類，大致分“風寒感冒，，和“風 熱感冒”。風熱感冒症狀：喉痛、發燒、沒胃口、流鼻涕（濃 稠、黃綠色）、有濃痰。 2009曱型_流感在中醫學上屬“溫病，，範_，因外感 風熱毒邪導致的以發熱、咽喉不適或疼痛、咳嗽為特徵的臨床 新發傳染病’輕症的核心病機為風熱毒邪侵襲肺衛，，。 本發明人基於中醫溫病學理論，集北京市著名溫病學家的 臨床經驗，集經典名方麻杏石甘湯、銀翹散、白虎湯于一體， 發明了治療流感的中藥及其劑型，從而完成了本發明。 由於流感病毒對某些西藥產生耐藥性，所以有些抗病毒藥 物無法對感冒病毒進行廣譜有效的治療，本發明的目的是為了 201201823 , 解決上述問題，發揮中藥傳統優勢，提供了-種治療包括？型 腳1流感在⑽流感的中藥及中藥片劑和顆粒劑，從主動清除 翻風邪絲方面著手，提高人體抗越力。 、 本發明的技術方案如下： “一種治療流感的中藥’其中所述中藥由下列重量份的原料 藥製成，所述原料藥包括炙麻黃3〜9份、生石膏3〇〜9〇份、 金銀花10〜30份、連翹10〜30份、黃答15〜30份、知母6 〇 〜20份和青蒿10〜30份。 上述技術方案中所述的中藥，其中所述各成分的重量份為 炙麻黃β份、生石膏30份、金銀花15份、連船5份、黃答 15份、知母10份和青蒿15份。 上述技術方案中所述的中藥’其中所述原料藥還包括浙貝 母卜20份、炒杏仁3〜1〇份、牛蒡子1〇〜2〇份、薄荷3〜1〇 份。 〇 上述技術方案中所述的中藥，其中所述各成分的重量份為 炙麻黃6份、生石膏30份、金銀花15份、連趣㈣、黃答 15份、知母1〇份、浙貝母1〇份、炒杏仁9份、牛夢子π份 和薄荷6份。 上述技術方案中所述的中藥，其中所述原料藥還包括生甘 草3〜1〇份。 上述技術方案中所述射藥，其中所述各成分的重量配比 為炙麻黃6份、生石膏30份、金銀花15份、輪15份黃 5 201201823 芩15份、知母10份、浙貝母l〇份、炒杏仁9份、牛等子u 份、青蒿15份、薄荷6份、生甘草iQ份。 該治療流感的中藥的製備方法，是將所述的中藥組分水 煎，或研成粉末浸泡引用；或中藥其他的常規方法；該治療由 曱型_等流感病毒引起的流感的帽的贿是製備治療感 冒藥物的用途；該感冒是由病毒引起的感冒；該治療由甲型 H1N1等>域病毒；丨起的流感的巾藥_途是製備治療感冒發 熱症狀的藥物。 本發明的巾㈣可輯财__ f規綠製備成任何 其他常規内服製劑，中藥片劑和膠囊射的中藥與載體的比例 可以使用常規的重量比。 上述原料藥中炙麻黃性溫，味辛、微苦，有發汗散寒、」 肺平喘、利水細的功效；生騎性絲，味辛、甘，有清 瀉火、除須止渴的功效；金銀花性寒味甘，有清熱解毒、^ 的功效；連紐微寒味苦，具有清熱解毒、消腫散結的功效 知母性味苦寒，具錢熱瀉火，生__功效；黃答性^ 寒，有清熱燥濕，瀉火解毒的功效，青蒿性寒，味苦、辛，# 月…解暑除洛’截遽的功效；炙麻黃疏風解表、生石膏清圣 解肌’針對毒邪侵襲肺衛為君藥；金銀花、連翹、黃答、青_ Z母有清鱗毒、增録熱之力、增加解毒之性_，為 =m、妹性微溫味苦，有降氣止咳平喘、潤腸通便 ^，_雜味絲，有清熱散結、化鼓咳的功效·牛 201201823 蒡子性寒，味辛、苦右 宁古有疏政、宣肺透療、解毒利咽的功效； 入浙’恤、散熱、㈣、咖作用；加 类伽、炒杏仁具有化瘦止咳的作用，牛蒡子、薄荷具有透 毒、祛佐樂’生甘草性平味甘，有補脾益氣、清熱解 :藥=、緩急止痛、調和諸藥的功效;加入生甘草調和 銀春、帛冑于上焦為使藥’該方集經典名方麻杏石 Ο Ο 白虎料—體，具有疏散風熱，清鑛毒之效，治疼 侵襲肺衛引起的發熱、咽喉不適或疼痛、魏、咽喉 2等’用於甲型_流歧其他病毒導致的上呼吸道感毕 具有侵襲肺衛證。 本U的巾藥及中藥賴和顆蝴具有以下有益效果： 本發明所__料_是普賴材，患者可以报方便 的購買並煎服； 2 ^所選中藥材均是#通藥材，不會給患者的治療 ’經濟負擔’從而免去了患者的後顧之憂； 3 it明的⑽崎包括甲型__在内的流感的 ^症狀如發熱、咽喉不適或疼痛、咳漱等有明顯的治 癒效果； 4、由=藥的廣譜抗菌的特性，能有效的治療對達菲等抗 病藥物具有耐藥性的病毒所引起的流感。 以下通過試驗例來 這些試驗触含了 有时益效果， 月中藥k取物的6a床療效觀察試驗。 7 201201823 試驗例1 .本發明藥物與達菲在治療甲型H1N1流感的對比 1、 患者的選擇條件·· 篩查394名患者’所有患者均符合⑴、符合衛生部制定 的診斷標準，⑵、14_70歲，⑶、發病時間（出現發熱& 腋下體溫37. 5°C伴咽痛、咳漱症狀）72小時 排除標準：（丨）、妊娠，（2)、肺炎、嚴重基礎病、免疫缺 陷，（3)、入組前服用抗病毒藥，（4)、有臟器功能衰竭 2、 組別： 分別設置空白對照組、達菲（奥司他韋）組、本發明藥物 組（以下稱中藥組）和（達菲+中藥）組，其中達菲組服 用達菲75mg Bid晝三夜一、中藥組服用中藥2〇〇ml晝三 夜一、（達菲+中藥）組服用（達菲75mg Bid +中藥20〇ml) 晝三夜一 空白組 達菲組 中藥組 達菲聯合 中藥組 P 入組數目 103 98 92 101 年齡（歲） 19. 6±7.4 19.1±6. 2 18. 7±5.3 19. 2±6. 3 0.278 性別（男） 59 58 58 51 0.798 學生 83 89 94 94 0.905 基礎病（例） 1 0 0 1 投藥時間（h) 38. 9±19 39. 3±18. 7 43. 3±18.8 43. 4+21.6 >0.05 疫苗接種 0 2 2 2 0.608 201201823 3、 人口學特徵：（n = 394) 4、 臨床特徵：（n=394) 空白組 達菲組 中藥組 達菲聯合中藥組 P 最尚體溫 0.673 38〇C 21 24 28 24 38.1 — 39t： 50 50 60 53 39〇C 21 24 15 24 咳漱 72 72 78 72 0.712 咽痛 54 43 66 63 0.016 頭痛 39 45 45 46 0.957 流鼻洋 24 24 19 23 0.608 鼻塞 17 15 15 22 0.515 咳痰 26 16 18 14 0.665 5、主要觀察指標評估： 指標 空白組 達菲組 中藥組 達菲聯合中藥組 P 投藥一退熱時 間(hr) 中位數 26 20 16 15 <0. 00： 均值±標準差 33· 9士 23. 5土 24.1士 18.1±12.2 <0.00: 23.6 20.3 20.7 與空白組比（P) <0.01 <0.01 <0.01 與達菲比（P) >0.05 >0. 05 與中藥組比（P) >0.05 201201823 、次要觀察指標201201823 VI. Description of the Invention: [Technical Field] The present invention belongs to the technical field of traditional Chinese medicine, and particularly relates to the technical field of traditional Chinese medicine and traditional Chinese medicine tablets and granules for treating influenza caused by sputum H1N1 specific influenza virus. [Prior Art] Influenza (influenza) is an acute respiratory infection caused by influenza virus, and it is also a disease with strong contagiousness and rapid spread. Beans are mainly transmitted by droplets in the air, contact between people or contact with contaminated objects. Typical clinical symptoms are acute high fever, generalized pain, significant weakness, and mild respiratory symptoms. The general autumn and winter season is its high incidence, and the complications and deaths caused by it are very serious. Influenza viruses can be classified into three types: 曱 (A), B (B), and C (C). The 曱 type virus often undergoes antigenic variation. It is highly contagious, spreads rapidly, and is prone to widespread epidemics.甲 Influenza A 1 is also known as A (H1N1) flu. The former is called human swine flu. The sputum H1N1 flu virus is a type A flu virus carrying a subtype of swine flu virus strain, including North America and Europe. The ribonucleic acid (RNA) gene fragment of the three influenza viruses, swine flu, avian flu and human flu, is characterized by both Asian swine flu and African swine flu virus. A pattern 1, early symptoms of influenza clinical manifestations similar to ordinary human influenza, including fever, cough, sore throat, body aches, headache, fever, etc., some may also have diarrhea or vomiting, muscle pain or fatigue, red eyes Etc., some patients can progress rapidly in 201201823, with fierce, sudden high fever, body temperature over 39, even secondary to severe pneumonia, acute respiratory distress syndrome, pulmonary hemorrhage, chest ''., night, whole blood cells 乂, kidney failure, sepsis, shock and Reye syndrome, beer failure and multiple organ damage' lead to strong. The patient's original underlying disease can also aggravate 'the current treatment of flu-like diseases in patients with flu, although these drugs can reduce the severity of the disease and improve the chances of survival, (4) overuse and due to long-term use The virus develops resistance. [Summary of the Invention] Traditional Chinese medicine believes that flu is an "invasion of exogenous evils". Because the origin of the virus, whether it is the nasal mucosa or the respiratory tract, is outside the viscera, so it is called "exogenous evil," Chinese medicine according to the characterization of the disease and physical response Classification, roughly divided into "cold cold," and "wind and cold". Wind and cold symptoms: sore throat, fever, no appetite, runny nose (thick, yellow-green), thick. 2009 曱 type _ flu in Chinese medicine is a "warm disease, Fan _, due to exogenous wind-heat toxic evil caused by fever, throat discomfort or pain, cough characterized by a new infectious disease" mild core pathogenesis In order to invade the lungs, the inventors of the present invention, based on the theory of traditional Chinese medicine, studied the clinical experience of the famous warming doctors in Beijing, and collected the classic names Fangma Xingshigantang, Yinqiaosan and Baihutang. In one embodiment, the invention discloses a traditional Chinese medicine for treating influenza and a dosage form thereof, thereby completing the present invention. Since influenza virus is resistant to certain western medicines, some antiviral drugs cannot perform broad-spectrum effective treatment on cold viruses, and the object of the present invention It is for 201201823, to solve the above problems, to give full play to the traditional advantages of traditional Chinese medicine, to provide a kind of treatment including the type 1 foot flu in the (10) flu Chinese medicine and traditional Chinese medicine tablets and granules, from the active removal of the wind wind evil thread to improve the human body resistance The technical solution of the present invention is as follows: "a traditional Chinese medicine for treating influenza" wherein the traditional Chinese medicine is made of the following raw materials by weight, including ricinus 3 to 9 , Gypsum 3〇~9〇 parts, 10~30 parts of honeysuckle, forsythia 10~30 copies, yellow A 15~30 parts altogether 6 billion ~ 20 copies and Artemisia annua 10~30 copies. The traditional Chinese medicine described in the above technical solution, wherein the parts by weight of the components are ramie yellow β, 30 gypsum, 15 honeysuckle, 5 ship, yellow 15, 10, and Artemisia annua 15 copies. The traditional Chinese medicine described in the above technical solution, wherein the raw material medicine further comprises 20 parts of Zhebeimubu, 3~1 parts of fried almonds, 1〇2 parts of burdock, and 3~1 parts of mint. The traditional Chinese medicine described in the above technical solution, wherein the parts by weight of each component are 6 parts of ramie, 30 pieces of raw gypsum, 15 parts of honeysuckle, 15 pieces of Lianqu (4), 15 parts of Huang answer, 1 part of Zhimu, Zhejiang 1 part of Fritillaria, 9 parts of fried almonds, π parts of Niu Mengzi and 6 parts of mint. The traditional Chinese medicine described in the above technical solution, wherein the raw material medicine further comprises 3 to 1 part of raw licorice. The medicine according to the above technical solution, wherein the weight ratio of each component is 6 parts of ramie, 30 parts of raw gypsum, 15 parts of honeysuckle, 15 parts of yellow 5 201201823 芩 15 parts, 10 parts of Zhimu, Zhejiang Fritillaria l, part of fried almonds, 9 parts of cattle, 15 parts of Artemisia annua L., 6 parts of mint, raw licorice iQ parts. The preparation method of the traditional Chinese medicine for treating influenza is to decoction the traditional Chinese medicine component or to make a powder soaking reference; or other conventional methods of traditional Chinese medicine; the treatment bribes the flu caused by the influenza virus It is a preparation for treating a cold medicine; the cold is a cold caused by a virus; the treatment is caused by a type A H1N1 or the like; a domain virus; a flu-infected medicinal medicine is a medicine for treating a fever and a fever. The towel of the present invention can be prepared into any other conventional internal preparations, and the ratio of the traditional Chinese medicine tablet and the capsule to the traditional Chinese medicine to the carrier can be used in a conventional weight ratio. In the above-mentioned raw materials, the ramie is warm, slightly bitter, slightly bitter, has sweating and dispelling cold, and has the effect of relieving lungs and relieving the water; the nature of riding, silky, sweet, sweet, and diarrhea, in addition to quenching thirst Honeysuckle is cold and sweet, has the effect of clearing away heat and detoxifying, and it has the effect of clearing away heat and detoxifying, reducing swelling and dispersing. It has the effect of maternal taste bitter cold, with heat and diarrhea, and __ efficacy; yellow Answer sex ^ cold, there is heat and dampness, purging fire detoxification effect, Artemisia argyi cold, bitter taste, Xin, #月... 解暑除洛's paraplegic effect; 炙麻黄疏风解表,生石膏清圣The muscles of the muscles attack the lungs for the poisonous evils; the honeysuckle, forsythia, yellow, and blue _Z have clear venom, increase the power of heat, increase the detoxification _, =m, sister sex It tastes bitter, has a cooling effect, relies on cough, relieves asthma, and relieves bowel movements. ^, _ miscellaneous silk, has the effect of clearing away heat and dissipating the phlegm and sputum. · 201201823 蒡子性寒,味辛,苦右宁古有疏政, Xuanfei transfusion, detoxification and pharyngeal effect; into the Zhejiang 'shirt, heat, (four), coffee effect; plus gamma, fried almonds have the effect of thinning and relieving cough, burdock, mint It is toxic, 祛佐乐' raw licorice is flat and sweet, has spleen and qi, clearing heat: medicine =, relieve pain, reconcile the effects of various medicines; add raw licorice to reconcile silver spring, sputum on the upper focus The medicine 'the party's classic name Fang Ma Xing Shi Ο Ο white tiger material body, with the effect of evacuating wind heat, clearing the poison, curing the pain caused by the lungs caused by fever, throat discomfort or pain, Wei, throat 2, etc. The upper respiratory tract sense caused by other viruses in the type A _ 歧 具有 has an invasive lung health syndrome. The U towel and the Chinese medicine Lai and the butterfly have the following beneficial effects: The invention __ material _ is the Pu Lai material, the patient can report the convenient purchase and decoction; 2 ^ the selected Chinese medicinal materials are #通药材, Will not give the patient a 'economic burden' to avoid the patient's worries; 3 it is clear (10) Saki including the type A _ flu symptoms such as fever, throat discomfort or pain, cough, etc. The curative effect; 4, by the broad-spectrum antibacterial properties of the drug, can effectively treat the flu caused by viruses resistant to Duffy and other disease-resistant drugs. The following test cases are used to test the efficacy of the 6a bed of the Chinese medicine k. 7 201201823 Test Example 1. Comparison of the drug of the present invention and Tamiflu in the treatment of influenza A (H1N1) 1. Selection conditions of patients·· Screening of 394 patients' All patients were in compliance with (1) and met the diagnostic criteria established by the Ministry of Health, (2) 14_70 years old, (3), onset time (appear fever & underarm temperature 37. 5 ° C with sore throat, cough symptoms) 72 hours exclusion criteria: (丨), pregnancy, (2), pneumonia, severe underlying disease, immunity Defects, (3), taking antiviral drugs before enrollment, (4), organ failure 2, group: setting blank control group, Tamiflu (oseltamivir) group, drug group of the invention (below) It is called Chinese medicine group) and (Duffy + Chinese medicine) group, in which Duffy group takes Tamiflu 75mg Bid昼 three nights, Chinese medicine group takes Chinese medicine 2〇〇ml昼 three nights one, (Duffy + Chinese medicine) group to take (Da Philippine 75mg Bid + Chinese medicine 20〇ml) 昼 three nights and one blank group Tamifi group Chinese medicine group Tamiflu combined Chinese medicine group P Number of enrollment 103 98 92 101 Age (years) 19. 6±7.4 19.1±6. 2 18. 7 ±5.3 19. 2±6. 3 0.278 Sex (Male) 59 58 58 51 0.798 Student 83 89 94 94 0.905 Basic disease (example) 1 0 0 1 Dosing time (h) 38. 9±19 39. 3±18. 7 43. 3±18.8 43. 4+21.6 >0.05 Vaccination 0 2 2 2 0.608 201201823 3. Population Characteristics: (n = 394) 4. Clinical characteristics: (n=394) The blank group Duffy group Chinese medicine group Tamiflu combined with Chinese medicine group P The most common body temperature 0.673 38〇C 21 24 28 24 38.1 — 39t: 50 50 60 53 39〇C 21 24 15 24 Cough 72 72 78 72 0.712 Sore throat 54 43 66 63 0.016 Headache 39 45 45 46 0.957 Runny nose 24 24 19 23 0.608 Nasal plug 17 15 15 22 0.515 Cough 26 16 18 14 0.665 5, Evaluation of main observation indicators: indicator blank group Tamiflu group Chinese medicine group Tamiflu combined Chinese medicine group P administration a fever time (hr) median 26 20 16 15 < 0. 00: mean ± standard deviation 33 · 9 ± 23. 5 soil 24.1±18.1±12.2 <0.00: 23.6 20.3 20.7 to blank group ratio (P) <0.01 <0.01 <0.01 and Duffy ratio (P) >0.05 >0.05 Compared with traditional Chinese medicine group ( P) >0.05 201201823, secondary observation indicators
併發症、合併症、抗生素 指標 空白組 達菲組 中藥組 —--- 達菲聯合中孳相 支氣管炎 0 0 1 --~~ 0 肺炎 0 2 0 0 肺結核 1 0 0 -〜- 0 .併發症總數（％) 1 (1.0) 2 (2.0) 1 (1.1) '"-~~--- 0 抗生素（％) 1---- 35 (34.0) 10 (10.9) 16 (16.3) *~~--- 8 (7.9) <0.001 p 住院天數 項目 空白組 達菲組 中藥組 達非聯合中藥組 ~~~~~-- P 住院天數 — 6. 0±1. 4 5. 8±1.6 6. 2±1.4 6.6±1.「^~~~ ---- 0.046 達菲組和聯合組比較ρ==0. 041 ;其他各組間比較均>0.05 201201823 9、藥物經濟學： 達菲組 中藥組 單曰治療藥物費用（元） 55.5 16 總治療藥物費用（元） 276 80 10、 藥物依從性： 依從性均比較理想其中2例入組治療3天出院（中藥組和 聯合用藥組各1例），3例入組治療4天出院（空白、達菲 和聯合用藥組各1例）。 11、 藥物安全性： 中藥組1例，噁心、嘔吐，不能耐受，提前終止試驗。 12、 初步研究結果： (1) 、三個治療組退熱效果均顯著優於空白組； (2) 、中藥與奥斯他韋相比：療效相似，藥物費用少； (3) 、聯合治療組未顯示優勢。 11 201201823 試驗例2 :本發明藥物對内毒素致發熱家兔體溫的影響 1、試驗材料 a、 受試藥物 本發明藥物，含2g生藥/ml中國中醫科學院中藥研究所 及劑型室提供，批號：090811。臨床用量為I48g/日， 按60公斤體重計算為2.47g/kg，試驗選用臨床等效劑 量及高一倍劑量，家兔用15. 30、7. 65 g/kg。 b、 陽性對照藥 阿司匹林泡騰片，阿斯利康制藥有限公司生產，批號為 080217,臨床用量丨片/日（每片含〇.5g)，按6〇公斤 體重計算為〇. 〇17片/吆，試驗選用臨床等效劑量，家 兔用 0· 025g/kg。 c、 動物 豕兔，1. 5-2. 0kg，雌雄各半，由北京市海澱區學院路 通利實驗動物養殖場提供，合格證號：SCKX(京）2〇〇5_ 0003。 d、 内毒素 大腸才干菌内毒素’ Sigma產品，購自北京科海軍舟生物 技術發展中心。 e、 儀器 7151型半導體溫度計，上海醫用儀絲生產。 201201823 2、試驗方法和結果 按陳奇主編的《中藥藥理研究方法學》（人民衛生出版社， 北京，1993年）第244頁的方法檢測本發明藥物對内毒素 致發熱家兔體溫的影響 'Complications, comorbidities, antibiotics, blank group, Tamiflu group, Chinese medicine group---- Duffy combined with sputum bronchitis 0 0 1 --~~ 0 pneumonia 0 2 0 0 tuberculosis 1 0 0 -~- 0. Total number of diseases (%) 1 (1.0) 2 (2.0) 1 (1.1) '"-~~--- 0 Antibiotics (%) 1---- 35 (34.0) 10 (10.9) 16 (16.3) *~ ~--- 8 (7.9) <0.001 p Hospitalization days blank group Duffy group Chinese medicine group Dafei combined Chinese medicine group ~~~~~-- P Hospital days - 6. 0±1. 4 5. 8±1.6 6. 2±1.4 6.6±1. “^~~~ ---- 0.046 Tami group and combination group ρ==0. 041; comparison between other groups>0.05 201201823 9. Pharmacoeconomics: Philippine group Chinese medicine group monotherapy drug costs (yuan) 55.5 16 total treatment drug costs (yuan) 276 80 10, drug compliance: compliance is ideal, 2 cases were enrolled in the treatment for 3 days discharged (Chinese medicine group and combination group) 1 case), 3 cases were discharged from the hospital for 4 days (1 case of blank, Tamiflu and combination group) 11. Drug safety: 1 case of Chinese medicine group, nausea, vomiting, intolerance, early termination test. 12. Preliminary research conclusions Results: (1) The antipyretic effect of the three treatment groups was significantly better than that of the blank group; (2) Compared with oseltamivir, the Chinese medicine had similar curative effect and less drug cost; (3) The combination treatment group showed no advantage. 11 201201823 Test Example 2: Effect of the drug of the present invention on body temperature of endotoxin-induced fever rabbit 1. Test material a, test drug The drug of the present invention, containing 2 g of crude drug/ml, Chinese Medicine Research Institute of Chinese Academy of Traditional Chinese Medicine and dosage form, provided by batch number : 090811. The clinical dosage is I48g / day, calculated according to 60 kg body weight is 2.47g / kg, the test uses the clinical equivalent dose and the high dose, the rabbit used 15. 30, 7. 65 g / kg. b, positive The reference drug aspirin effervescent tablets, produced by AstraZeneca Pharmaceutical Co., Ltd., batch number 080217, clinical dosage tablets / day (each tablet contains 〇. 5g), calculated as 6 〇 kg body weight 〇. 〇 17 tablets / 吆, The clinical equivalent dose was used for the experiment, and 0. 025g/kg for rabbits. c, animal rex rabbits, 1. 5-2. 0kg, male and female, provided by Tonglili Experimental Animal Farm of College of Haidian District, Beijing, qualified Certificate No.: SCKX (Beijing) 2〇〇5_ 0003. d, endotoxin large intestine bacteria Toxins' Sigma product, purchased from Beijing Kehai Junzhou Center for Biotechnology Development. e, instrument 7151 type semiconductor thermometer, Shanghai medical instrument wire production. 201201823 2. Test methods and results The effect of the drug of the present invention on the body temperature of endotoxin-induced fever rabbits was examined according to the method of "Chinese Traditional Medicine Pharmacology Research Methodology" edited by Chen Qi (People's Health Publishing House, Beijing, 1993).
方法取健康家兔稱體重’試驗當曰測正常肛門溫度2次。 選肛溫在38. 5-39. 5°C及兩次溫度相差〇. 4。(：以内的動物供 試驗用。試驗共設6組，每組6只。分別為模型對照組， 陽性對照藥組，本發明藥物兩個劑量組（詳見表）。以 140ng/ml/kg的大腸桿菌内毒素由家兔耳靜脈注射，丨小時 後，測肛溫升高值，按升高值調整分組後分別灌胃給予相 應藥物。模型對照組灌胃同體積的蒸餾水。藥後卜2、3、 4小時各測肛溫一次，以不同時間所測肛溫與基礎肛溫之差 值，為體溫變化值。 表1 本發明藥物對内毒素致熱家兔體溫的影響 劑量 藥後不同時間雜溫變化值（。〇，x±SD ) 組別 ---—--二--- _g/kg 0h lh 2h 3h 4h 1.63+0.31 1.73+0.40 1.12±0,62 0. 87±0. 57 〇. 85±〇. 33木木 0. 65±0· 28木木 0. 28±0, 23* 0. 25±0.19* 1. 22+0.19 0. 98±0.15木木 0. 62±0. 15 0.45±0.15 1.47+0. 56 1.32+0.64 0.75+0. 63 0.52+0.31 林p<0_ 01 ;採用重複測量方差分析，處方2大劑量組與模型組比較P<〇. 05 棋、螌對照_―― 1.42+0.24 陽性對照_0.025 1.43+0.31 15.30 1. 43j〇. 22 本發明藥物7.65 1.38+0.20 注：動物數均為6只，與模型對照級比較；jjpa. 3、結果 結果如表1顯示’本發明藥物的15. 3〇g/kg劑量對内毒素引起 家兔的體溫升高有一定的抑制效果。 13 201201823 【實施方式】 為使本發明的技術方案便於理解，以下結合實驗例來對本發明 作進一步的說明。 實施例1 : 稱取炙麻黃6份、生石膏30份、金銀花丨5份、連翹i5份、黃芩 15份、知母1〇份和青蒿1〇份，用水煎服，每日一劑。 實施例2 : 稱取炙麻黃3份、生石膏9〇份、金銀花1()份、連船b、黃答 20份、知母6份和和青蒿15份，用水煎服，每日一劑。… 實施例3 ： 稱取炙麻黃9份、生石膏6〇份、金銀花3〇份、連赵別份、黃； 30伤知母2〇份和青蒿3〇，用水煎服每日一劑。 實施例卜2、3中炙麻黃疏風解表、生 毒邪侵盤胎，« π”、、肝肌对筆 :毒、金銀花、連㈣答、青萬和知母有料 實施例4: I、、之、增加解毒之性的作用，為該方之臣藥。 稱取炙麻黃6份、 15份、知母10份 青高10、薄荷3， 實施例5j 生石膏3G份、金銀花15份、連㈣份黃答 、浙貝母ίο份、炒杏仁9份、牛蒡子15份: 用水煎服，每曰一劑。 、連龜10份、黃签 、牛蒡子20份和青 稱取炙麻黃3份、生石膏⑽份、金銀花 20伤知母6份、浙貝母6份 萬15、薄荷I用水煎服，每曰一劑: 14 201201823 實施例6 : :灸=、生石膏6〇份、金銀花3〇份、連她 月同10、薄何6 ’用水煎服，每日一劑。 浙目1侧4、5、6在實施例卜2、3的基礎上增加了炒杏仁、 腸.和牛#子’射炒社性微溫味苦，麵氣止咳平喘、潤 Ο 性味絲，有清熱散結、化痰止咳的二 子L，味辛、苦，有疏散、宣肺透療、解毒利咽的功效， σ強了藥物的清熱散結、疏散的療效。 2炙麻K 6g、生石膏3Gg、金銀花15g、連船、黃答μ、 知母log、浙貝母10g、炒杏仁9§、牛夢子l5g、青萬 溥荷6g、生甘草10g，用水煎服，每日一劑。Method Take the weight of healthy rabbits' test when the normal anus temperature was measured twice. The temperature of the anus is selected at 38. 5-39. 5 ° C and the temperature difference between the two 〇. 4. (The animals were used for the test. There were 6 groups in each group, 6 in each group. They were model control group, positive control group, and two dose groups of the drug of the present invention (see table). 140 ng/ml/kg The Escherichia coli endotoxin was injected into the ear vein of rabbits. After an hour, the sinus temperature was increased. The group was adjusted according to the elevated value and then administered with the corresponding drugs. The model control group was given the same volume of distilled water. 2, 3, 4 hours each measured the temperature of the anus, the difference between the anus temperature and the basic anus temperature measured at different times, the body temperature change value. Table 1 The effect of the drug of the present invention on the body temperature of the endotoxin-induced rabbits Miscellaneous temperature change values at different times (.〇, x±SD) Group------two--- _g/kg 0h lh 2h 3h 4h 1.63+0.31 1.73+0.40 1.12±0,62 0. 87±0 57 〇. 85±〇. 33木木0. 65±0·28木木0. 28±0, 23* 0. 25±0.19* 1. 22+0.19 0. 98±0.15 木木0. 62± 0. 15 0.45±0.15 1.47+0. 56 1.32+0.64 0.75+0. 63 0.52+0.31 Lin p<0_ 01 ; using repeated measures analysis of variance, prescription 2 large dose group compared with model group P<〇. 05 chess,螌Control _—— 1.42+0. 24 positive control _0.025 1.43+0.31 15.30 1. 43j〇. 22 The drug of the invention 7.65 1.38+0.20 Note: the number of animals is 6, compared with the model control level; jjpa. 3, the results of the results as shown in Table 1 'present invention The dose of 15.3〇g/kg of the drug has a certain inhibitory effect on the increase of body temperature of the rabbit caused by endotoxin. 13 201201823 [Embodiment] In order to make the technical solution of the present invention easy to understand, the following experimental examples are used to make the present invention Further explanation: Example 1: Weigh 6 parts of ramie, 30 pieces of raw gypsum, 5 parts of honeysuckle, 5 parts of forsythia, 15 parts of astragalus, 1 part of Zhimu and 1 part of Artemisia annua L. One dose per day. Example 2: Weigh 3 parts of castor bean, 9 parts of raw gypsum, 1 part of honeysuckle, 20 pieces of ship b, 20 parts of yellow, 6 parts of Anemarrhena and 15 parts of Artemisia annua L. Decoction, one dose per day.... Example 3: Weigh 9 parts of castor yellow, 6 parts of raw gypsum, 3 parts of honeysuckle, even Zhaobie, yellow; 30 wounded mother 2 parts and artemisia 3 〇, decoction with water one day. Example b, 2, 3 in the ramie yellow wind to solve the table, the poisonous evil invading the tire, « π", liver muscle pen: poison Honeysuckle, Lian (4) A, Qing Wan and Zhimu have the material of Example 4: I, and, to increase the role of detoxification, for the prescription of the party. Weigh 6 parts of ramie, 15 parts, 10 parts of Zhimu High 10, mint 3, Example 5j 3 g of gypsum, 15 parts of honeysuckle, even (four) yellow, Zhejiang fritillaria ίο, 9 portions of fried almonds, 15 portions of burdock: Decoction with water, one dose per serving. 10 turtles, 10 yellow hamburgers, 20 sirloin, and 3 scallions, 3 gypsum, 10 gypsum, 20 nymphs, 6 francs, 15 medlar, mint I, decoction, Each dose: 14 201201823 Example 6: : moxibustion =, raw gypsum 6 〇, honeysuckle 3 〇, even her month with 10, thin He 6 'shui decoction, one dose a day. On the basis of the examples 2 and 3, Zhemu 1 side 4, 5, and 6 added frying almonds, intestines, and cattle #子's sizzling social micro-temperature bitterness, face cough, asthma, and sputum. There are clearing and dispersing, phlegm and cough, the second son L, Weixin, bitter, evacuation, Xuanfei transfusion, detoxification and pharyngeal effect, σ strong drug clearing heat, evacuation effect. 2 ramie K 6g, raw gypsum 3Gg, honeysuckle 15g, Lian Chuan, Huang A μ, Zhimu log, Zhejiang Fritillaria 10g, fried almond 9 §, Niu Mengzi l5g, Qingwan 溥6g, raw licorice 10g, fried with water Take a daily dose.
G :灸麻黃3份、生石㈣份、金銀花㈣、連翹 份、知母6份'浙貝母6份、炒杏㈡份、牛蒡子2Q份 1 〇g、薄荷3g、生甘草6g，用水煎服，每日一劑。 童旅例9 : ^取灸麻黃9份、生石膏⑼份、金銀花30份、連油份、黃答 /、知母20份、浙貝母2〇份、炒杏仁6份、牛蒡子1〇份、青 同3〇g、薄荷1Gg、生甘草3g，用水煎服，每日一劑。 實施例7〜9在實施例4〜6的基礎上增加了青蒿、薄荷和生 甘草，其中青蒿性寒，味苦、辛，有清熱解暑，除蒸，截癌的功 15 201201823 效；薄荷性涼、味辛，有疏風、散熱、辟穢、解毒的作用；生甘 草性平味甘，有補脾益氣、清熱解毒、祛痰止咳、緩急止痛、調 和諸藥的功效，該三種藥物輔助其餘藥物充分發揮臨床療效。 實施例10 :本發明中藥片劑的製備： (1) 制粒：按照中藥和羧甲基澱粉鈉按品質比3:丨的比例稱取 實施例1〜9中任一實施例制得的中藥和羧曱基澱粉 鈉’並將羧曱基澱粉鈉分成兩分，一份為1/3量備用， 另一份為2/3量加入到活性成分中’以濃度為70%的 乙醇為濕潤劑制粒，制得的顆粒於6〇它下乾燥； (2) 壓片·取乾燥顆粒’加入備用的1/3量的幾甲基殿粉納和片 劑總重量〇. 3%的硬脂酸鎂’以3kN壓力下壓成片劑。 amm u_:本發明中藥顆粒劑的製備 稱取實施例1〜9中任-實施例中所述的藥材，加水煎棄兩次，滤 過’取遽液，乾燥濃縮的浸膏’加中藥4倍量的乳糖，混句、制 拉即得。 在本發明中炙麻黃、生石膏是該方的主要藥物，金銀花、連 麵、知母和黃芩’是組方的重要辅助藥物，和炙麻黃、生石膏共 同形成了方劑的核心’是治療效果的主藥，炒杏仁、浙貝母、牛 ^子是加強該方療效的重要部分，青蒿、薄荷、生甘草輔助以上 藥物充分發揮臨床療效。 以上所述，僅為本發明的較佳實施例，並非對本發明作任何 I式上和實質上的限制’凡熟悉本專業的技術人員，在不脫離本 技術方案範圍内，當可利用以上所揭*的技術内容，而做出 16 201201823 的些許更動、修飾與演變等 PHRi 手段化均為本發明的等效實施例； 同時’凡依據本發明的實質枯彳赶斜丨、丨L成G: moxibustion ephedra 3 parts, raw stone (four) parts, honeysuckle (four), forsythia, and Zhimu 6 parts 'Zhebei Fritillaria 6 pieces, fried apricots (2) parts, burdock 2Q parts 1 〇g, mint 3g, raw licorice 6g, Decoction with water, one dose per day. Child Travel Example 9 : ^ Take moxibustion ephedra 9 parts, raw gypsum (9), 30 honeysuckle, oil, yellow A/20, Zhimu 20, Zhejiang Fritillaria 2, fried almond 6, burdock 1 〇, 青同3〇g, mint 1Gg, raw licorice 3g, decoction with water, one dose per day. Examples 7 to 9 added Artemisia annua L., mint and raw licorice on the basis of Examples 4 to 6. Among them, Artemisia annua L. was cold, bitter and pungent, and had heat and heat, and it was steamed and blocked. 15 201201823 The mint is cool and spicy, and it has the functions of dispelling wind, dissipating heat, irritating and detoxifying; raw licorice is flat and sweet, and has the effects of replenishing spleen and replenishing qi, clearing away heat and detoxifying, relieving cough, relieving pain, and reconciling various medicines. The three drugs assist the remaining drugs to fully exert clinical efficacy. Example 10: Preparation of Chinese medicine tablet of the present invention: (1) Granulation: Chinese medicine prepared according to any one of Examples 1 to 9 is weighed according to a ratio of quality to 3: 丨 according to a traditional Chinese medicine and sodium carboxymethyl starch. And sodium carboxymethyl starch ' and sodium carboxymethyl starch is divided into two, one part is 1/3 amount for use, the other part is added to the active ingredient in 2/3 amount 'wet with 70% ethanol The granules are prepared, and the obtained granules are dried under 6 Torr; (2) tableting and taking dry granules 'additional 1/3 amount of methicillin powder and total tablet weight 〇. 3% of hard Magnesium humate was compressed into tablets at a pressure of 3 kN. Amm u_: preparation of the traditional Chinese medicine granules of the invention, the medicinal materials described in any of the examples 1 to 9 are weighed, and the water is decocted twice, filtered, and the sputum is dried, and the concentrated concentrated extract is added with the traditional Chinese medicine 4 The amount of lactose is mixed and mixed. In the present invention, ramie and gypsum are the main drugs of the party, and honeysuckle, sorghum, anemarrhena and scutellaria are important auxiliary drugs of the prescription, and the core of the prescription is formed together with ramie and gypsum. The main medicine of the effect, fried almond, Zhejiang Fritillaria and Niuzizi are important parts to strengthen the efficacy of this prescription. Artemisia annua L., peppermint and raw licorice supplement the above drugs to give full play to clinical efficacy. The above is only the preferred embodiment of the present invention, and is not intended to limit the scope of the present invention. Anyone skilled in the art can use the above without departing from the scope of the present invention. The technical content of the disclosure, and the PHRi means of making some changes, modifications and evolutions of 16 201201823 are all equivalent embodiments of the present invention; at the same time, 'the essence of the present invention is sloppy, 丨L into
Ab^m^u ^ ^ 射1對·^上實侧所作的任何等同變 化的更動、修飾與演變，妗 』寸丨J1： 二仍屬於本發明的技術方案的範圍内。 【圖式簡單說明】 【主要元件符號說明】The change, modification and evolution of any equivalent change made by Ab^m^u ^ ^ on the real side of the pair is still within the scope of the technical solution of the present invention. [Simple diagram description] [Main component symbol description]