I?64287 九、發明說明： 【發明所屬之技術領域】 本發明涉及一種藥物組合物，特別是以治療憂鬱症爲主 功效的藥物組合物。它可以作為改善憂鬱症的藥物或保 健食品》 本發明還涉及一種以治療憂鬱症爲主功效的藥物組 合物的製備方法。 【先前技術】 憂鬱症是一種常見的疾病。據統計在一般人口中大約 有25〇/〇女性在其一生中經歷過憂鬱症，男性中約有ι〇%左 右經歷過憂鬱症（張春興著：《現代心理學》）。世界衛生 組織提供的資料：憂在全世界的發病率約爲11%，目 前全球約有3.4億精神患者，而且這個數位仍成上升 趨勢’調查發現在今後2〇年，憂·將會上升爲全球第 一大常見疾病。 、目前國内外市場上抗憂鬱症藥物中基本以百優解、賽 洛特、左洛複等5經色胺再攝取抑制劑（SSRJs)爲主， 其作用機理是通過增加人體神經介質内5經色胺成分含量 緩解憂鬱症狀。這類藥物都有不同程度的副作用，研究表 明夕“這些藥品中含有的複安栓對平衡人體機能有作用，但 更夕時候’它們還是無法讓患者平靜下來。，，近年來百優 5 解荨憂鬱症藥物疋否有害已成爲嚴重的社會問題，其中赛 洛特更是早在19%年紐魏存在有安全縣，自2崎 年開始已陸續從市場上召回。2004年6月，美國紐約州總 檢察長指控英關f|素妓公司爲了獲取利潤，欺編性隱 瞒了服用賽洛特與“增加青少年自殺傾向及行爲的風 險”之間有聯繫的研究報告。在這種背，如何研發生 産新-代副作則、又能有明顯抗鬱作㈣藥物已成爲全 球醫藥界所關注的問題。 【發明内容】 爲I克服現有技術的不足，本發明的目的在於提供一種 以抗憂鬱症爲主功效的植物藥組合物。它可以作盖 憂鬱症的藥物或保健食品。 〜° 具體而言，本㈣涉及—種治療賴症爲 ^組合物⑴，其·在於包括至少-選自町組方= 万： 、 (A) 4〜18重量份人參，3〜14重量份甘草； 蓋兩Γ)由4〜18重量份人參萃輯轉取物或者乙醇 魅由3〜14重量份甘草萃取的水萃取物或者乙醇萃 4 18重里份人參，纟3〜14重量 水卒取物或者乙醇萃取物；或者 卓卒和 (D)，3〜14重量份甘草由4〜18重 水萃或物或者乙料取物。 福人參卒料 旦其卜值得留意的是，本文中所指的重量份指的是重 里比例例如，就上述⑷組方而言，當使用重量為4一 18公克的人參時，需搭配重量為3 _ 14公克的甘草·而 同樣地’當使用重量為4 _ 18公斤的人參時，則需搭配3 _ 14公斤的甘草。 在上述藥物組合物⑴组方（A)或者⑻中還可以 進一步包括： (E)3〜14重量份大棗；或者 ()由3 Η重羞伤大棗萃取的水萃取物或者乙醇萃 X的樂物組合物較佳的組方包括·· 7〜11重量名 人參^〜8重量份甘草，或者由7〜u重量份人參萃耳 的^萃取物或者乙料取物和由4〜8重量份甘草萃取备 水萃取物或者乙醇萃取物。 、在上述的較佳組方中還可以包括:4〜8重量份大棗， 或者由4 大棗萃取的水萃取物或者乙醇萃取物< 物二發Γ還涉及—種治療憂#症爲主功效的藥物組会 _在於，包括3〜10重量份的人參乙醇萃取 物或者水卒取物，α2〜α8重量份㈣草酸或者 =’其巾難的是人參乙轉取物含2G_4G%人參總息 武’甘草酸或者甘草次酸純度爲80-98%。 ί發明的藥物組合物⑵還可以進-步包括划5〜02重 里^的大棗乙醇萃取物或者水萃取物，其愤 乙醇卒取物含〇_5—3%大棗cAMP。 裘 其中’值得留意的是，本文中所指人參總皂武、大農 •cAMP及甘料或者甘草:规的含量.、純妓與本文所述 的含量及純度不同時，人參、大棗萃取物及甘草酸或者甘 草次酸的重量份應依比例增減。例如.，當含量或純度減半 時，重量份應加倍。 又 本發明的另-目的是提供上述以抗錄症爲主功效 的藥物組合物的製備方法。 本發明涉及一種製備上述藥物組合物（1)的方法， 其特徵在於包括以下步驟： (1) 將4〜18重量份人參用60_75%乙醇溶液煎提，經層 析分離純化，得第一萃取物； (2) 將3〜14重量份甘和水煎提，濃縮、乾燥得 萃取物； ⑶將步驟1得到的第一萃取物和步驟2得到的第二萃 取物混合粉碎，過篩，得所述的藥物組合物。 在上述的製備方法中還進一步包括以下步驟··將3〜 ^重量份大棗在⑼·75%乙醇驗萃取，再經層析分離純 化後’得帛三萃取物，將其加人所述㈣触合物中。 本發明還涉及-種上述藥物組合物⑵的方法，其 特徵在於包括以下步驟將α2〜α8重量份純度⑽—鄕 甘草酸或者甘草:域、3〜1〇重量份含2()_4()%人參總阜武 的人參萃取物混合粉碎，得所述的藥物組合物。〜 在製備藥物組合物⑵的方法中，其射以包括以 下步驟：將0.〇5〜0.2重量份含1%大棗cAMp的大棗萃取 物用/3環祕包和得大棗萃取物包和體；將大棗萃取物包 和體加人所述的藥物組合物中。 具體而言’本發明的藥物組合物中只有2〜3味：人參、 甘草、（和大棗）。 人參（ginseng):人參中含有腺苷酸環化酶（AC)刺 激腺苷’並含有磷酸二酯酶抑制劑，兩者有相乘作用，共 同使細胞内cAMP升咼；人參還能促使笨丙胺酸透過血腦 屏障’增進多巴胺（DA)和去甲腎上腺素（NE)的合成， 從而提高了腦内DA和NE的濃度。 甘草（liquorice):甘草中的甘草酸和甘草次酸，是 cAMP磷酸二酯酶強抑制劑，而通過抑制cAMp磷酸二酯 酶則可減少CAMP降解，從而提高大腦中樞系統cAMp 的利用度。 大棗Gujuba):大棗中含有大量cAMP樣物質，而這 種外源性非水解類cAMP能參與機體中cAMp的代謝過 程，忐類比激素作用，使得細胞内cAMp含量增高。 本發明組方中人參、甘草、大棗三者配伍，合同作用， 通過啟動腺苷酸活化酶（AC)，增加腦細胞内cAMp的濃 度；通過抑制cAMP磷酸二酯酶，減少了 cAMP的降解， 提向cAMP的利用度；而cAMp的濃度和活性增強，則可 增加NE等神經遞質的合成與釋放（詳見《神經科學原理》 士冊關於cAMP對兒茶酚胺CAs生成作用的有關論述）。 足個過程，即是本方能夠抗憂鬱的現代藥理學作用機理。 換。’之’爲了完成本發明的目的’本發明提出以下重量份 較佳的組方。 1、組方一： 人參4〜18份 甘草3〜14份 13,642^7 更較佳的爲由下述重量配比的原料製成的藥劑： 人參7〜11份 甘草4〜8份 2、 紅方二： 人參4〜18份 甘草3〜14份大棗3〜14份 更較佳的爲由下述重量配比的原料製成的藥劑： 人參7〜11份 甘草4〜8份 大農4 〜8份 3、 紕方三： 人參乙醇萃取物（含20-40%人參總皂甙）3〜1〇份 甘草次酸（80-98%純度）0.2〜0·8份 大棗乙醇萃取物（含0.5—3%大棗cAMP) 〇 〇5〜〇2 份 ’* 組方二中’較佳的爲由下述重量配比的原料製成的藥 劑：人參乙醇萃取物（含30%人參總皂甙）、甘草次酸（9〇% 純度）、大棗乙醇苹取物（含1%大棗cAMP):其中人參 乙醇萃取物5份，甘草次酸〇. 4份， 大棗乙醇萃取物〇. 1份。 爲了製備本發明的藥物組合物，可以直接按照規定的 組方重量配比使用人參和甘草的粉碎物，直接製成藥物組 合物。而在此組方的基礎上加入大棗的乾粉製成另一種藥 物組合物。 此外，本發明的藥物組合物還可以按照組方中限定的 成分重量配比採用至少一種原料的乾粉，加入其他成分的 水萃取物或者醇萃取物來製成，或者至少一種原料的水萃 13.64287 取物或者醇萃取物，加入其他成分乾粉的來製成。 本發明藥物組合物的製作方法包括： 方法一： b將4〜18重量份人參用6〇_75%乙醇溶液煎提，經 層析分離純化，得第一萃取物； 2、 將3〜14重量份甘草財煎提，濃縮、乾 二萃取物； 3、 將步驟1得到的第一萃取物和步驟2得到的第二 萃取物混合粉碎，過篩，得本發明組方藥物組合物（1)。 在上述的方法中較佳爲人參7〜11重量份，甘草4〜8 重量份。 -方法二： 方法一中可以再加入大棗3〜14重量份，較佳爲4〜8 重量份，乙醇溶液煎提，經層析分離純化，用石環糊精包 和知大棗萃取物包和體，將其與第一萃取物、第二萃取物 混合粉碎’得本發明組方藥物組合物（2)。 方法三： 1、 將0.05〜0.2重量份含1%大棗cAMP的大棗萃取 物用/S環糊精包和得大棗萃取物包和體； 2、 將大棗萃取物包和體與〇.2〜0.8重量份9〇%純产 甘草次酸、3〜10重量份30%純度人參萃取物混合粉碎， 得本發明組方三藥物組合物。 在上述方法中各組份較佳重量份爲·· 含1%大棗cAMP的大棗萃取物〇. 1重量份（用9倍 畺的石環糊精包和），含30%人參總皂甙的人參萃取物5 重里伤，純度爲90%的甘草次醆〇 4重量广 本發明植物藥組合物的解決方二二 療“繁症”的基礎上，結合現代醫學二 的治療機理，研製開發出來的一細抗憂症 (副^ 物組合物，無毒 長期服用。來从口療憂營症的藥物或保健食品 =發明的的熱組合物可以單位劑量形式給藥，給藥 途仅可爲腸道或非腸道，如口服笼 +Jt 膠囊、Ή J '給藥劑型例如片劑、 劑算：:Ϊ劑、溶液劑、混懸劑、乳劑、顆粒 ϋί糸Γ 製劑、緩釋製劑、控㈣劑及各種微粒 :樂糸統。爲了將單位給藥劑型製成片劑，可以廣泛使用 ^貝域習知的各種髓。關於載體的例子是，例如稀釋劑 :、吸收劑’如麟、糊精、硫酸㈣、乳糖、甘露醇、蔬糖、 氣化鈉、㈣糖、尿素、碳g_、白陶土、彳 ，等；濕潤_合劑，如水、甘油、聚乙 2丙醇、澱粉聚、糊精、糖聚、蜂蜜、葡萄糖溶液、阿 伯膠聚、明賴、幾甲基纖維素鈉、紫膠、曱基纖維素、 ，酉夂奸、聚乙烯轉燒崎；崩_，例如錢殿粉、海 ，酸鹽、_粉、褐藻殿粉、碳酸氫納與枸櫞酸、碳酸妈、 聚氧乙稀山梨㈣脂肪麵、十二絲雜鈉、甲基纖維 素、乙基纖維素等；崩解抑制劑，例如雜、三硬脂酸甘 油酯、可可脂、氫化油等；吸收促進劑，例如季銨鹽、十 二烷基硫酸鈉等；潤滑劑，例如滑石粉、二氧化矽、玉米 澱粉、硬脂酸鹽、硼酸、液體石蠟、聚乙二醇等。還可以 將片劑進一步製成包衣片，例如糖包衣片、薄膜包衣片、 腸溶包衣片，或雙層片和多層片。爲了將給藥單元製成丸 劑’可以廣;乏使用本領域習知的各種载體。關於載體的例 子是，例如稀釋劑與吸收劑，如葡萄糖、乳糖、澱粉、可 可脂、氫化植物油、聚乙烯吡咯烷酮、Gelucire、高嶺土、 滑f粉等；粘合劑，如阿拉伯膠、黃#膠、明膠、乙醇、 蜂蜜液糖、米糊或麵糊等；崩解冑彳，如奶旨粉、乾燥殿 粉、海藻酸鹽、十二絲續_、甲基纖維素、乙基纖維 素等。爲了將給藥單兀製成栓劑，可以廣泛使用本領域習 ^的各種載體。關於載體的例子是，例如聚乙二醇、印磷 1旨、Γ可脂' 高級醇、高級醇的酉1、明膠、半合成甘油酯 專。爲了將給藥單元製成膠囊，將本發明組合物或者萃取 ，與上述的各種_混合，並將由此得_混合物置於硬 轉囊中。也可將本發明組合物或者萃取物 :混懸於水性介質中形成混懸劑，亦可裝入硬 斜21卜才丨如而要’也可以向藥物製劑中添加著色劑、香 科、橋味劑、甜麵或其他材料。 實施方式】 方特徵製備本發明所述的藥物組合物。以下實施例僅僅是 爲了說明’並非限定本發明。 實施例1 參見第-圖’採用本領域技術人員f知的方法將9 公斤人參用75%純度的乙醇煎提，虹㈣析分離純化， 得第一萃取物’該萃取物含有40%人參總皂甙；將6公斤 甘草用水溶液煎煮、過濾、濃縮、乾燥，得第二萃取二 將第-萃取物與第二萃取物混合，粉碎得本發^且方一藥 物組合物。 ' 實施例2 參見第二圖’使用6G%的乙輯9公斤人參進行醇 提，經上柱層析分離純化，得第一萃取物；將6公斤甘草 用水溶液煎煮、過濾、、濃縮、賴，得第二萃取物；採甩 75%乙醇醇提6公斤大f ’經上柱層析分離純化，得第三 萃取物，將其用9倍量的沒環糊精包和，得—包和物；將 第一萃取物、第二萃取物與第三萃取物的包和體混合粉 碎’得本發明組方二藥物組合物。 實施例3 參見第二圖，將1§大棗萃取物（含1%大棗cAMP) 用9g/5環糊精包和得i〇g包和物；將1〇g包和物與5〇g 人參萃取物（含30%人參皂甙）、吆甘草次酸（9〇%純度） 混合粉碎，得本發明組方三藥物組合物。 · 實施例4 將4公斤人參，3公斤 普通技術人員習知的势備分碎成乾粉，採用本領域 蜂蜜等藥_合劑製成蜜丸將得關乾粉混合後，加入 實施例5 實施例6 將市售的4公斤人泉，3八 本領域普通技術人員習知彳’採用 ?，加•额棗%乙=物== 藥_體製成片劑。 又物糊精專 實施例7 將I4公斤甘草’ 1S公斤人參的水萃取物（市售 碎成乾粉’採用本領域普通技術人員f知的製備方法將^ 到的乾粉混合後’加人雜、糊群藥用载體製成片劑。 實施例8 將4公斤份人參，14公斤經實施例丨的方法得到的甘 草水萃取物；粉碎成乾粉，採用本領域普通技術人員習知 的製備方法將得到的乾粉混合後，再加入經實施例2方去 實施例9 將市售的3公斤含有4〇%人參總皂武的人參乙醇萃取 ^0.2。公斤的甘草次酸混合後得—混合物，採用本領域 技術人貝習知的方法製賴物社。 ’ 實施例10 將市售的4公斤含有2〇%人參總皂戒的人表 二公斤甘草酸混合後得—混合物，採用本領= '貝驾知的方法製成藥物軟膠囊。 實驗例本發明物的抗憂鬱實驗 實驗例1 :小鼠懸尾實驗 實驗動物：ICR小鼠 實驗藥品： 提供本發明實施例3藥物：歐納爾生物工程技術有限公司 解鬱丸··鄭州豫密藥業股份有限公司產。 品 帕羅西斤（赛樂特）：令美天津史克制藥ΐ限公司產 實驗方法： 劑量級（188.5mg/ 一、分組：①本發明實施例3藥物大 16 13.642,37 公斤）' @本發明實施例3藥物中劑量組（94 25mg/公斤）、 @本發明實施例3藥物小劑量組（47.i25mg/公斤）、®解 鬱丸組（650mg/公斤）、©帕羅西汀組（16 7mg/公斤）、@ 生理鹽水組。（每組10隻小鼠） —、給藥：上述藥物水溶液按〇 2mLa〇g體重灌胃給 ^，每天2次’共7天，最後—次給藥後丨小時進行 實驗。 ^懸尾實驗：將顿尾（距尾尖⑽處）用膠布點 牡向山$面5cm的木條上縣a Λ八吐 鼠的不動咖。 分鐘，記職5分鐘内小 實驗結果： 統計軟體進行方差分析計算與模 型 不動時間 實驗結果用SPSS 11.5 組比較的p值。 動物數 (隻） 組別 生理鹽水組 (模型組） 122.66±33.53 解鬱丸組I?64287 IX. Description of the Invention: [Technical Field of the Invention] The present invention relates to a pharmaceutical composition, particularly a pharmaceutical composition which is mainly effective for treating depression. It can be used as a medicine for improving depression or a health food. The present invention also relates to a method for preparing a pharmaceutical composition which is mainly used for treating depression. [Prior Art] Depression is a common disease. According to statistics, about 25 〇/〇 of women in the general population have experienced depression during their lifetime, and about ι% of men have experienced depression (Zhang Chunxing: Modern Psychology). Information provided by the World Health Organization: The incidence rate of worry in the world is about 11%. At present, there are about 340 million mental patients in the world, and this number is still on the rise. The survey found that in the next two years, the worry will rise to The world's largest common disease. At present, anti-depression drugs in the domestic and international markets are mainly based on Baiyoujie, Selot, Zuoluofu and other 5 tryptophan reuptake inhibitors (SSRJs), and its mechanism of action is through the increase of human neural media. The content of the tryptamine component relieves the symptoms of depression. These drugs have varying degrees of side effects. Studies have shown that "the complex ampoules contained in these drugs have an effect on balancing the body's functions, but on the other day, they still cannot calm the patients." Whether or not the drug of depression has become harmful has become a serious social problem. Among them, Celote has a safe county as early as 19% in New York. It has been recalled from the market since the beginning of 2 years. In June 2004, the United States The New York State Attorney General accused Yingguan f|Suxi Company of fraudulently concealing a study linked to the use of Celote and "increasing the risk of suicidal tendencies and behavior among adolescents" in order to make a profit. How to develop and produce new-generation vice-presences, and to have obvious anti-cancer work (4) Drugs have become a concern of the global pharmaceutical industry. [Disclosure] To overcome the deficiencies of the prior art, the object of the present invention is to provide an A botanical drug composition with depression as its main function. It can be used as a medicine for preventing depression or a health food. ~° Specifically, this (4) relates to the treatment of diarrhea as a composition (1), · Include at least - selected from the group side = 10,000:, (A) 4 to 18 parts by weight of ginseng, 3 to 14 parts by weight of licorice; cover two Γ) from 4 to 18 parts by weight of ginseng extract or ethanol charm 3 to 14 parts by weight of licorice extract water extract or ethanol extract 4 18 liters of ginseng, 纟 3 to 14 weight of water stroke or ethanol extract; or Zhuo and (D), 3 to 14 parts by weight of licorice 4~18 heavy water extract or material. It is worth noting that the weight fraction referred to in this article refers to the proportion of heavy weight. For example, in the above (4) group, when using weight For 4 to 18 grams of ginseng, use a weight of 3 _ 14 grams of licorice · and the same 'when using ginseng with a weight of 4 _ 18 kg, you need to match 3 _ 14 kg of licorice. The compound (1) group (A) or (8) may further comprise: (E) 3 to 14 parts by weight of jujube; or () a combination of water extract extracted from 3 Η heavy shame jujube or ethanol extract X The preferred group consists of 7~11 weight ginseng^~8 parts by weight licorice, or 7~u parts by weight Extracting the extract of the ear or the extract of the extracting material and extracting the water extract or the ethanol extract from 4 to 8 parts by weight of the licorice. The preferred composition of the above may further comprise: 4 to 8 parts by weight of jujube, Or the water extract or the ethanol extract extracted from the 4 jujubes, and the second group of cockroaches, which are related to the treatment of dysfunction, mainly include 3 to 10 parts by weight of ginseng ethanol extract or Water stroke, α2~α8 parts by weight (4) Oxalic acid or = 'The towel is difficult to be ginseng B transfer containing 2G_4G% ginseng total qi' glycyrrhizic acid or glycyrrhetinic acid purity is 80-98%. The composition (2) can further include a jujube ethanol extract or an aqueous extract of 5 to 02 cc. The sorghum ethanol extract contains 〇5-3% jujube cAMP.裘 裘 值得 值得 值得 值得 值得 值得 值得 值得 值得 值得 值得 值得 值得 值得 值得 值得 值得 值得 值得 值得 值得 值得 值得 值得 值得 值得 值得 值得 值得 值得 值得 值得 值得 值得 值得 值得 值得 值得 值得 值得 值得 值得 值得 值得 值得 值得 值得 值得 值得 值得 值得 值得 值得The weight fraction of the substance and glycyrrhizic acid or glycyrrhetinic acid should be increased or decreased in proportion. For example, when the content or purity is halved, the parts by weight should be doubled. Still another object of the present invention is to provide a process for the preparation of the above pharmaceutical composition which is mainly based on anti-recording. The invention relates to a method for preparing the above pharmaceutical composition (1), which comprises the following steps: (1) 4~18 parts by weight of ginseng is decoctioned with 60_75% ethanol solution, and purified by chromatography to obtain a first extraction. (2) 3 to 14 parts by weight of lyophilized water, and concentrated to obtain an extract; (3) mixing and pulverizing the first extract obtained in step 1 and the second extract obtained in step 2, and sieving Said pharmaceutical composition. Further, in the above preparation method, the following steps are further included: - extracting 3 to ^ parts by weight of jujube in (9)·75% ethanol, and separating and purifying by chromatography, and obtaining the extract of the third extract, which is added as described above. (d) in the conjugate. The present invention also relates to a method for the above-mentioned pharmaceutical composition (2), which comprises the steps of: α2~α8 parts by weight purity (10)-glycyrrhizic acid or licorice: domain, 3~1〇 parts by weight containing 2()_4() The ginseng extract of ginseng ginseng is mixed and pulverized to obtain the pharmaceutical composition. ~ In the method of preparing the pharmaceutical composition (2), the method comprises the steps of: adding 0.5 to 0.2 parts by weight of the jujube extract containing 1% jujube cAMp with the /3 ring and the jujube extract The package and the body; the jujube extract package and the body are added to the pharmaceutical composition described. Specifically, the pharmaceutical composition of the present invention has only 2 to 3 flavors: ginseng, licorice, and (and jujube). Ginseng (ginseng): ginseng contains adenylate cyclase (AC) to stimulate adenosine' and contains phosphodiesterase inhibitors, which have a multiplicative effect, which together promote intracellular cAMP; ginseng can also promote stupidity Alanine crosses the blood-brain barrier' to enhance the synthesis of dopamine (DA) and norepinephrine (NE), thereby increasing the concentration of DA and NE in the brain. Liquorice: Glycyrrhizic acid and glycyrrhetinic acid in licorice, a strong inhibitor of cAMP phosphodiesterase, and the inhibition of CAMP degradation by inhibiting cAMp phosphodiesterase, thereby increasing the utilization of cAMp in the brain central nervous system. Jujube Gujuba): Jujube contains a large amount of cAMP-like substances, and this exogenous non-hydrolyzed cAMP can participate in the metabolism of cAMp in the body. The action of steroids on hormones increases the intracellular cAMp content. In the group of the invention, the combination of ginseng, licorice and jujube, the contract function, increases the concentration of cAMp in brain cells by activating adenylate activating enzyme (AC); and reduces the degradation of cAMP by inhibiting cAMP phosphodiesterase The availability of cAMP is increased; while the concentration and activity of cAMp are increased, the synthesis and release of neurotransmitters such as NE can be increased (for details, see the book "The Principles of Neuroscience" on the role of cAMP in the production of catecholamine CAs). The whole process is the modern pharmacological mechanism of action that can resist depression. change. In order to accomplish the object of the present invention, the present invention proposes the following components in a preferred part by weight. 1. Group one: ginseng 4 to 18 parts licorice 3 to 14 parts 13,642^7 More preferably, the preparation is made of the following weight ratio raw materials: ginseng 7 to 11 parts licorice 4 to 8 parts 2, red Side two: ginseng 4 to 18 parts licorice 3 to 14 parts jujube 3 to 14 parts more preferably a medicament made of the following weight ratio raw materials: ginseng 7 to 11 parts licorice 4 to 8 parts Da Nong 4 ~8 parts 3, 纰方三: ginseng ethanol extract (containing 20-40% ginseng total saponin) 3~1 甘 parts glycyrrhetinic acid (80-98% purity) 0.2~0·8 parts jujube ethanol extract ( Containing 0.5-3% jujube cAMP) 〇〇5~〇2 parts '* Group 2' is preferably a preparation made of the following weight ratio raw materials: ginseng ethanol extract (containing 30% ginseng total) Saponin), glycyrrhetinic acid (9〇% purity), jujube ethanol extract (containing 1% jujube cAMP): 5 parts of ginseng ethanol extract, glycyrrhetinic acid citrate. 4 parts, jujube ethanol extract 〇 . 1 serving. In order to prepare the pharmaceutical composition of the present invention, a pulverized material of ginseng and licorice can be directly used in accordance with a prescribed compositional weight ratio to directly form a pharmaceutical composition. On the basis of this group, a dry powder of jujube was added to prepare another pharmaceutical composition. Further, the pharmaceutical composition of the present invention may be prepared by using a dry powder of at least one raw material according to the weight ratio of the components defined in the composition, adding an aqueous extract or an alcohol extract of the other ingredients, or water extracting of at least one raw material 13.64287 The extract or the alcohol extract is prepared by adding dry powder of other ingredients. The preparation method of the pharmaceutical composition of the present invention comprises the following steps: b: 4~18 parts by weight of ginseng is decanted with 6〇_75% ethanol solution, and purified by chromatography to obtain a first extract; 2. 3~14 The weight of the licorice decoction, concentrated, dry two extracts; 3, the first extract obtained in step 1 and the second extract obtained in step 2 are mixed and pulverized, and sieved to obtain the pharmaceutical composition of the present invention (1) ). In the above method, 7 to 11 parts by weight of ginseng and 4 to 8 parts by weight of licorice are preferred. - Method 2: In the first method, 3 to 14 parts by weight, preferably 4 to 8 parts by weight, of the jujube may be further added, and the ethanol solution is decomposed, purified by chromatography, and coated with the stone ring dextrin and the jujube extract. The package and the body are mixed and pulverized with the first extract and the second extract to obtain the pharmaceutical composition (2) of the present invention. Method 3: 1. Pack 0.05~0.2 parts by weight of jujube extract containing 1% jujube cAMP with /S cyclodextrin and obtain jujube extract package and body; 2. Add jujube extract package and body with 2 to 0.8 parts by weight of 9% by weight of pure glycyrrhetinic acid, 3 to 10 parts by weight of 30% pure ginseng extract are mixed and pulverized to obtain the pharmaceutical composition of the present invention. In the above method, the preferred parts of each component are: jujube extract containing 1% jujube cAMP. 1 part by weight (packed with 9 times sputum stone cyclodextrin), containing 30% ginseng total saponin Ginseng extract 5 heavy wounds, purity of 90% of licorice scorpion 4 weight, the solution of the botanical drug composition of the invention is based on the "busy disease", combined with the treatment mechanism of modern medicine 2, research and development A fine anti-allergic disease (substrate composition, non-toxic long-term use. Drugs or health foods from the oral therapy camping disease = the invented thermal composition can be administered in unit dosage form, the administration route can only be Intestinal or parenteral, such as oral cage + Jt capsules, Ή J 'administered dosage forms such as tablets, dosage:: elixirs, solutions, suspensions, emulsions, granules, preparations, sustained release preparations, Controlled (four) agents and various microparticles: Lexus. In order to form a unit dosage form into tablets, various kinds of pith can be widely used. The examples of the carrier are, for example, a diluent: an absorbent agent such as Lin , dextrin, sulfuric acid (four), lactose, mannitol, vegetable sugar, sodium vapor, (four) sugar, urea , carbon g_, white clay, earthworms, etc.; moist_mixtures, such as water, glycerin, polyethylene glycol, starch polydextrin, dextrin, sugar poly, honey, glucose solution, Aberdeen, Ming Lai, methine Cellulose sodium, shellac, sulfhydryl cellulose, smuggling, polyethylene to burn saki; collapse _, such as Qiandian powder, sea, acid salt, _ powder, brown algae powder, sodium bicarbonate and tannic acid , carbonated mother, polyoxyethylene sorbus (four) fat noodles, twelve silks of sodium, methyl cellulose, ethyl cellulose, etc.; disintegration inhibitors, such as miscellaneous, glyceryl tristearate, cocoa butter, hydrogenated oil And so on; absorption enhancers such as quaternary ammonium salts, sodium lauryl sulfate, etc.; lubricants such as talc, cerium oxide, corn starch, stearates, boric acid, liquid paraffin, polyethylene glycol, etc. The tablet may be further formed into a coated tablet, such as a sugar coated tablet, a film coated tablet, an enteric coated tablet, or a double layer tablet and a multilayer tablet. In order to make the drug delivery unit into a pill, it can be widely used; Various carriers are known in the art. Examples of carriers are, for example, diluents and absorbents, such as Portuguese. Sugar, lactose, starch, cocoa butter, hydrogenated vegetable oil, polyvinylpyrrolidone, Gelucire, kaolin, slip powder, etc.; binders such as acacia, yellow #胶, gelatin, ethanol, honey liquid sugar, rice paste or batter, etc. Disintegration, such as milk powder, dry powder, alginate, 12-thin, methyl cellulose, ethyl cellulose, etc. In order to make a single tablet as a suppository, it can be widely used Various carriers for the field. Examples of the carrier are, for example, polyethylene glycol, imprinted phosphoric acid, succinic ester, higher alcohol, decyl 1, gelatin, semi-synthetic glyceride of higher alcohol. Capsules, the composition of the invention or extraction, mixed with the above various, and the resulting mixture is placed in a hard capsule. The composition or extract of the invention may also be suspended in an aqueous medium. Suspensions can also be filled with hard slanting 21 squid, as can be added to the pharmaceutical preparations can add colorants, fragrant, scented, sweet noodles or other materials. Embodiments] Square Features The pharmaceutical compositions of the present invention were prepared. The following examples are merely illustrative and are not intended to limit the invention. Example 1 Referring to Fig. - '9 kg of ginseng was decanted with 75% pure ethanol by the method known to those skilled in the art, and the mixture was separated and purified by rainbow (iv) to obtain the first extract 'the extract contained 40% ginseng total Saponin; 6 kg of licorice is decocted with an aqueous solution, filtered, concentrated, and dried to obtain a second extraction, the first extract is mixed with the second extract, and the medicinal composition is pulverized. 'Example 2 Refer to the second figure' using 6G% of the series of 9 kg of ginseng for alcohol extraction, separation and purification by column chromatography to obtain the first extract; 6 kg of licorice with aqueous solution, boiling, filtration, concentration, Lai, obtained the second extract; picking 75% ethanol alcohol to extract 6 kg large f' by column chromatography separation and purification, to obtain a third extract, which is packaged with 9 times the amount of non-cyclodextrin, and obtained - a package and a mixture; the first extract, the second extract and the package and body of the third extract are mixed and pulverized to obtain the pharmaceutical composition of the present invention. Example 3 Referring to the second figure, 1 § jujube extract (containing 1% jujube cAMP) was coated with 9 g/5 cyclodextrin and obtained as a package; 1 〇g package and 5 〇 g The ginseng extract (containing 30% ginsenoside) and the glycyrrhetinic acid (9 〇% purity) are mixed and pulverized to obtain the pharmaceutical composition of the present invention. · Example 4 4 kg of ginseng, 3 kg of ordinary technicians, the conventional preparations are divided into dry powder, using honey or other medicines in the field, the honey pill will be mixed with dry powder, and then added to the embodiment 5 The commercially available 4 kilograms of human springs, 3 of the ordinary people in the field, are known as 'using?, plus • date jujube% = substance == medicine _ body made into tablets. Further abalone specific Example 7 An aqueous extract of I4 kg of licorice '1 S kg of ginseng (commercially sold into dry powder) was mixed with dry powder by a preparation method known to those skilled in the art. The medicinal carrier of the paste was prepared into tablets.Example 8 4 kg of ginseng, 14 kg of the licorice aqueous extract obtained by the method of Example ;; pulverized into a dry powder, using a preparation method well known to those skilled in the art After the obtained dry powders were mixed, the same procedure as in Example 2 was carried out, and the commercially available 3 kg of ginseng ethanol containing 4% ginseng total saponin was extracted and 0.2 kg of glycyrrhetinic acid was mixed to obtain a mixture. The company is manufactured by a method known in the art. 'Example 10 A commercially available 4 kg of a person containing 2% ginseng total soap ring is mixed with 2 kg of glycyrrhizic acid to obtain a mixture, using the skill = ' The method of the invention is made into a soft capsule of medicine. Experimental Example Anti-depression experiment of the present invention Experimental Example 1: Mouse tail suspension experiment Experimental animal: ICR mouse Experimental drug: Providing the drug of Example 3 of the present invention: Onar biological Engineering technology Company Jieyu Pill··Zhengzhou Yumi Pharmaceutical Co., Ltd. Product. Parosin (Selite): The United States Tianjin Shike Pharmaceutical Co., Ltd. production test method: Dosage level (188.5mg / I, group: 1 Inventive Example 3 Drug Large 16 13.642, 37 kg) '@Inventive Example 3 Drug Medium Dose Group (94 25 mg/kg), @Inventive Example 3 Drug Low Dose Group (47.i25 mg/kg), ® Jieyu Pill Group (650mg/kg), ©paroxetine group (16 7mg/kg), @Normal saline group (10 mice per group) —, administration: The above aqueous solution of drug is filled with 〇 2mL a〇g The stomach was given ^, 2 times a day for 7 days, and finally, after the administration, the experiment was carried out. ^Hanging experiment: The tail (from the tip of the tail (10)) was glued to the mountain and the surface was 5 cm. County a Λ 吐 吐 的 。 。 分钟 分钟 分钟 分钟 分钟 分钟 分钟 分钟 分钟 分钟 分钟 分钟 分钟 分钟 分钟 分钟 分钟 分钟 分钟 分钟 分钟 分钟 分钟 分钟 分钟 分钟 分钟 分钟 分钟 分钟 分钟 分钟 分钟 分钟 分钟 分钟 分钟 分钟 分钟 分钟 分钟 分钟 分钟 分钟 分钟 分钟 分钟 分钟 分钟 分钟 分钟Saline group (model group) 122.66±33.53 Jieyu pill group
5?：21±52：5〇 51^^92 6〇.41±36.42 帕羅西、汀組 本發明實施例 藥物大劑量組 0.081 0.01 0.02 本發明實施例 藥物中劑量組 '—-- 72,68 士 55.37 0.0135?: 21±52:5〇51^^92 6〇.41±36.42 Paroxetine and Ting group The present invention is a high-dose group of drugs 0.081 0.01 0.02 The drug medium-dose group of the present invention '--- 72, 68 士55.37 0.013
1717
根據以上實驗，可以看出本 組和帕羅西_可減少小鼠懸尾後劑量 鹽水組（模型組）相比有顯著性差異，從可、曰/、生理 明物實施例3有抗憂功能。、 °以推斷本發 實驗例2:利血平誘導體溫下降實驗 實驗動物：ICR小鼠 實驗藥品： 本發明實關3:歐_生物工程技術有限公司提供。 利血平：上海復旦華藥業有限公司產品。 解鬱丸：鄭州豫密藥業股份有限公司產品。 帕羅西灯（赛樂特）：中美天津史克制藥有限公司産 品〇. 實驗方法： 一、 分組：①本發明實施例3藥物大劑量組（188.5mg/ 公斤）、@本發明實施例3藥物中劑量組（94.25mg/公斤）、 ®本發明實施例3藥物小劑量組（47.125mg/公斤）、®解 鬱丸組（650mg/公斤）、©帕羅西汀組（i6.7mg/公斤）、® 生理鹽水組。（每組10隻小鼠） 二、 給藥：上述藥物水溶液按〇.2ml/10g體重灌胃給 藥，每天2次，共7天。 13.642,87 三、最後一次給藥後測定小氡肛溫，然後經腹腔注射 利血平2mg/公斤，然後於注射利血平後2、3、4、5、6、7 小時分別測定小鼠肛溫。 實驗結果： 實驗結果用SPSS11·5統計軟體進行方差分析計算與 夺組比較的P值。 ~ 3小時肛 溫下降值 (度） ----- 組別 動物數 (隻） 2小時肛 溫下降值 (度） Ρ值 ρ值 4小時肛 溫下降值 (度） 生理鹽水組（模 型組） 2.33±0.85 Ρ值 1U 2.63±0.56 2.84±〇_84 帕羅西丁組 10 1.29±0.47 0.001 1.08±0.35 〇.〇〇ι —- 解鬱丸組 10 2.03±0.55 0.003 2.67±0.48 _ 0.2〇1 1·55±〇·64 0.001 本發明實施例3 藥物大劑量組 1.77±〇51 2.88*0.65 0.882 10 1.82±0.38 0.001 〇〇38 2.92±0.51 0.767 本發明實施例 1Π 0-001 藥物中劑量組 u.yuxu.*iH U.UU 1 0.48±0.加 0·85±0.21 0.001 本發明實施例3 藥物小劑量組 2.04±0.77 ^ 1U 2.63±0.43 0.815 0-275 1·45±0.55 0.001 6小時肛 溫下降值 (度） ---___ 組別 動物數 (隻） 5小時肛 溫下降值 (度） Ρ值 卩值 7小時肛 溫下降值 Ρ值 生理鹽水組（模 型組） 1Π 2.60±0.57 2.y7±U.ol 3·〇5±0.67 帕羅西汀組 10 1.44±0.32 0.001 2.51±0.47 0.72Π 解鬱丸組 10 2.49±0.60 0.033 2.71 ±0.46 O.fiftfX 2.76±0.59 0.272 本發明實施例3 藥物大劑量組 1Π 2.43±0.64 °-499 3.45±0.65 0.131 2.S8 士 U.44 0.683 2.30±〇.57 0.006 ---—, 19 本發明實施例3 藥物中劑量組 10 1.29±0.56 0.001 t_08±0.59 0.001 1.08±0.39 --- 0.001 本發明實施例3 藥物小劑量組 10 2.28±0.48 0.003 2.68±0.61 0.750 2.29±0.59 0.005 13,642^7 結論. 根據以上結果，可以看出本發明實施例3大、中、小: 劑量組均有對抗由於別血平引朗小鼠體溫降低的作 用，中劑量組與生理鹽水組（模型組）相比有極顯著性差 異，由此可以推斷本發明物實施例3有抗憂鬱功能。 本案传由沾悉此技藝之人任施匠思而為諸般修飾，熱 皆不脫如附申請範圍所欲保護者。 【圖式簡單說明】 第一圖爲本發明流程方法的第一實施例示意圖。 第二圖爲本發叼流程方法的第二實施例示意圖。 第三圖爲本發明流程方法的第三實施例示意圖。 【主要元件符號說明】 益 20According to the above experiment, it can be seen that this group and Paroxol _ can reduce the significant difference of the dose-dose saline group (model group) after the suspension of the mouse, and there is anti-worry from the sputum, sputum, and physiologically identifiable example 3. Features. ° ° to infer the present experiment Example 2: Reserpine induced body temperature drop test Experimental animals: ICR mice Experimental drugs: The present invention 3: Ou _ Bioengineering Technology Co., Ltd. provided. Reserpine: Shanghai Fudan Hua Pharmaceutical Co., Ltd. products. Jie Yu Wan: Zhengzhou Yumi Pharmaceutical Co., Ltd. products. Paroxet lamp (Selite): Sino-US Tianjin Shike Pharmaceutical Co., Ltd. product 〇. Experimental methods: 1. Grouping: 1 Inventive Example 3 drug high dose group (188.5 mg / kg), @本发明实施例3 drug middle dose group (94.25 mg / kg), ® inventive Example 3 drug low dose group (47.125 mg / kg), ® Jieyu pill group (650 mg / kg), © paroxetine group (i6.7 mg / kg ), ® saline group. (10 mice per group) 2. Administration: The above aqueous solution of the drug was administered as a solution of 2 ml/10 g body weight twice a day for 7 days. 13.642,87 3. After the last administration, the anal temperature of the sputum was measured, then the intraperitoneal injection of reserpine 2mg/kg, and then the mice were measured at 2, 3, 4, 5, 6 and 7 hours after the injection of reserpine. Anal temperature. Experimental results: The experimental results were analyzed by SPSS11·5 statistical software for analysis of variance and the P value compared with the group. ~ 3 hours of anal temperature drop value (degrees) ----- Number of animals in the group (only) 2 hours of anal temperature drop (degrees) Ρ value ρ value 4 hours of anal temperature drop (degrees) saline group (model group) 2.33±0.85 Ρ value 1U 2.63±0.56 2.84±〇_84 paroxetine group 10 1.29±0.47 0.001 1.08±0.35 〇.〇〇ι —- Jieyu pill group 10 2.03±0.55 0.003 2.67±0.48 _ 0.2〇 1 1·55±〇·64 0.001 Inventive Example 3 Drug high dose group 1.77±〇51 2.88*0.65 0.882 10 1.82±0.38 0.001 〇〇38 2.92±0.51 0.767 Inventive Example 1Π 0-001 Drug Medium Dosage Group U.yuxu.*iH U.UU 1 0.48±0. Plus 0·85±0.21 0.001 Inventive Example 3 Low-dose group of drugs 2.04±0.77 ^ 1U 2.63±0.43 0.815 0-275 1·45±0.55 0.001 6 hours Anal temperature drop value (degrees) ---___ Group animals number (only) 5 hours anal temperature drop value (degrees) Ρ value 卩 value 7 hours anal temperature drop value Ρ value saline group (model group) 1Π 2.60±0.57 2.y7±U.ol 3·〇5±0.67 paroxetine group 10 1.44±0.32 0.001 2.51±0.47 0.72Π Jieyu Pill Group 10 2.49±0.60 0.033 2.71 ±0.46 O.fiftfX 2.76±0.59 0.272 Inventive Example 3 High-dose drug group 1Π 2.43±0.64 °-499 3.45±0.65 0.131 2.S8 士U.44 0.683 2.30±〇 .57 0.006 ---, 19 Inventive Example 3 Drug Medium Dose Group 10. 1.29±0.56 0.001 t_08±0.59 0.001 1.08±0.39 --- 0.001 Inventive Example 3 Drug Low Dose Group 10 2.28±0.48 0.003 2.68± 0.61 0.750 2.29±0.59 0.005 13,642^7 Conclusion. Based on the above results, it can be seen that Example 3 of the present invention is large, medium, and small: the dose group has an effect against the decrease in body temperature of the blood of the blood of the blood, and the middle dose group There was a very significant difference from the saline group (model group), and it can be inferred that Example 3 of the present invention has an anti-depressant function. The case was adorned by those who are familiar with this skill, and they are all modified. The heat is not removed as the scope of the application. BRIEF DESCRIPTION OF THE DRAWINGS The first figure is a schematic diagram of a first embodiment of the flow method of the present invention. The second figure is a schematic diagram of a second embodiment of the method of the present invention. The third figure is a schematic diagram of a third embodiment of the flow method of the present invention. [Main component symbol description] Benefit 20