TWI335802B

TWI335802B -

Info

Publication number: TWI335802B
Application number: TW092104299A
Authority: TW
Inventors: Kikuji Yamaguchi
Original assignee: Kikuji Yamaguchi
Priority date: 2002-01-31
Filing date: 2003-02-27
Publication date: 2011-01-11
Also published as: JP2003219816A; TW200415994A

Description

1335802 (1) 玖、發明說明【發明所屬之技術領域】 · 發明所屬之技術領域本發明係關於含有蜂王漿之食品及藥劑。【先前技術】蜜蜂之咽頭腺所分泌之蜂王漿，已知具有抗菌作用、抑制糖尿病作用、增加血流作用、促進成長作用及抑制動脈硬化作用等多種藥理作用，廣泛地使用於營養補助食品、化粧品及醫藥部外用藥等。尤其是作爲醫藥品及醫藥部外用藥之蜂王漿配合劑，認爲可作爲滋養強壯，作爲虛弱體質及身體疲勞等之營養補給。上述可達成藥理作用之有效成份，確認含有10 -羥基一 2—癸烯酸（以下稱爲「10 — HDA」）、乙醯膽鹼、維生素B群、煙酸及泛酸等。爲得到更有效率之藥理作用，將這些有效成份施予單離、抽出及轉化等處理者，例如特開平4 — 279597號公報中揭示以酵素將蜂王漿分解成胜肽。另外，特開平4 -3 1 1 3 5 7號公報中揭示，10- HAD等脂肪酸含量高之蜂王漿萃取物之製造法。另外，特開平9 - 6U52號公報中揭示蜂王漿所含有之有效成份之高血壓蛋白寧轉換酵素抑制劑（血壓正常化作用）以及具有如胰島素作用（抗糖尿作用）之反式1〇 —羥基一 2-癸烯酸。然而，依據上述特開平4 - 279W7號公報以及特開平 (2) (2)1335802 9 - 67252號公報，該降低血壓作用係以投予小鼠或大鼠，確認顯示該作用之酵素抑制活性者。另外，關於毒性亦使用小鼠確認之。亦即，未曾使人經口攝取，實際地確認降低血壓作用，另外，不使因經口攝取所產生之消化不良及肝機能降低等之副作用發生之安全攝取量範圍尙不淸楚。本發明係有鑑於上述問題點，提供經口攝取蜂王漿，改善高血壓症及肩膀肌肉酸痛或頭痛等之自覺症狀，而且不產生副作用之安全食品及藥劑。【發明內容】發明之揭示亦即，本發明之第i特徵係具有蜂王漿之每日經口攝取量以生蜂王漿換算爲llg上限之適合型態之含有蜂王漿之食品。在此’本發明之含有蜂王漿之食品係無副作用，具有每曰攝取量以生蜂王漿換算爲4至llg之適合型態，所含有之蜂王漿之處理狀態係以生蜂王漿或冷凍乾燥生蜂王漿之乾燥蜂王漿之任何一種爲宜。本發明之第2特徵係以蜂王漿爲主要成份之藥劑，蜂王漿之每日經口投予量係以生蜂王漿換算爲llg上限之具有降低血壓作用之藥劑。本發明之第3特徵係上述之任何含有以蜂王漿爲主要成份之食品及藥品，蜂王漿之每日經口投予量係以生蜂王 -6- (3) 1335802 漿換算爲llg上限之具有降低血壓作用之藥劑。用以實施發明之最佳型態本發明中之蜂王漿，於未處理之蜂王漿（以下，生蜂王漿）時，一般約含有質量比之水份約爲66 I %、蛋白質約爲11至13%及脂質約爲5至10% ,以他無機物等。蜂王漿中之各種有效成份容易因光、熱及氧等變所以生蜂王漿於採取後，於不損及其有效成份下，冷燥除去水份，而可製成乾燥蜂王漿型態。本發明中蜂王漿之處理型態爲生蜂王漿、乾燥蜂或二者倂用，因爲可攝取原本所含有之全部成份（除份以外），所以適宜，因此而可得到所含有各種成份乘藥理作用。另外，生蜂王槳或乾燥蜂王漿，亦可施予不溶性質之可溶化處理及爲提高抗氧化作用之熱處理等》但不進行特定有效成份之分離、抽出等處理，其理由係上述之適合的相乘藥理作用，另外，可抑制因各種處使處理品之價格上升。本發明之含有蜂王漿之食品係具有蜂王漿之每曰攝取量以生蜂王漿換算爲llg之上限，以2至llg爲以4至1 1 g尤佳，以5至1 1 g最好之型態。上述經口攝取量與以往之蜂王漿之經口攝取量較，前者量多，而且爲不產生副作用之安全攝取量。稱爲 I 67 及其質，凍乾王漿了水之相蛋白是，因爲理而經口宜，相比 (4) (4)1335802 如此之每日經口攝取量之適合型態，可舉例如，1曰 2次攝取含有蜂王漿食品時，蜂王漿以生蜂王漿換算，最高配合量爲5.5g (例如4.5g)之上述食品爲1次份量之食品單位，其爲成型或包裝者。上述1次份量之食品單位用之成型物或包裝物之個數，以1個爲宜，但是亦可分爲 2個以上容易食用之個數。另外，1日之攝取次數，可以 1次，或分2次以上攝取，並無特別的限制。食品之成型物，可舉例如塊及錠（錠劑）等，包裝物可舉例如袋、塑膠杯、瓶、罐及膠囊等。具體的食品型態，例如1次份量是封入1個袋內之顆粒狀粉末，1次份量是充塡於2個杯子的果凍或1日份量是2 0個錠劑等》本發明之食品攝取期間，雖依個人差或藥理作用內容有所不同，但是以持續8週爲宜。另外’爲緩和蜂王獎特有的酸味，使口感良好，將本發明之食品，作爲使其他食品含有蜂王漿之配合物亦可》配合物可舉例如營養補助食品及健康食品等。蜂王漿可作爲具有降低血壓作用之藥劑。亦即，本發明之第2特徵之藥劑，係以蜂王漿爲主要成份，每日經口攝取量以生蜂王漿換算爲llg上限，具有降低血壓作用之藥劑。上述本發明之含有蜂王漿食品，亦可使用於藥劑。亦即，本發明之第3特徵之藥劑係含有上述任何一種本發明之食品爲主要成份，具有降低血壓作用之藥劑。 -8- (5) (5)1335802 本發明之藥劑係例如以本發明之食品爲主要成份，與經口投予用之各種載體共同製劑而可得之。上述載體可舉例如矯味劑、結合劑、賦形劑及滑澤劑等。另外，藥劑的劑形可以爲粉末、液狀、錠狀及膠囊狀等之任何劑形。 - 本發明之藥劑，除了作爲降低血壓劑以外，對於肩膀肌肉酸痛及頭痛等之自覺症狀，具有各種藥理作用。而且’即使投予亦不發生腹瀉、肝臟阻礙及糖尿病等副作用。 _ 本發明之藥劑之每日經口攝取量係以生蜂王漿換算爲 1 1 g上限即可，以2至1 1 g爲宜，以4至1 1 g尤佳，以5 至1 1 g最好。本發明之藥劑之適合投予期間，係與上述食品之攝取期間相同。【實施方式】以下係以實施例，更加詳細地說明本發明，但本發明不以此爲限。 β 另外，以下之實施例所使用之乾燥蜂王漿係準備JRJ 製藥株式會社製之蜂王漿冷凍乾燥粉末（以下，稱爲FD 粉末）。這是將生蜂王漿冷凍乾燥所得之淡黃色粉末散劑。 · 實施例 (實施例1 ) -9- (6) (6)1335802 (1)對象滿足①可攝取蜂王漿FD粉末，無過敏反應及嚴重基礎疾病等者，②合乎收縮壓爲140至159mmHg或舒張壓爲90至99Hg中任一項，③年齡爲30至50歲左右，最高爲6 5歲。對於臨床試驗的目的及方法等進行充份說明後，同意參加試驗之3 0名成人（男性8名，女性22 名）。年齡爲35至64歲，平均爲50.3歲，標準偏差爲8.6 歲。將上述3〇名被試驗者，任意分爲各15名之A組及B 組2組》另外，上述30名於攝取開始前，除了血壓以外未發現其他異常（肝臟、心臟及糖尿病等） (2 )攝取方法實施係包括事前觀察期2週、攝取期間8週及後續之觀察期間4週（恢復期間）。 · 將l.8g之上述FD粉末（相當於5.4g之生蜂王漿）’使A組i日：！次，B組〗日2次，經口攝取。攝取時間，由個人決定，並無特別的限制。另外，事前觀察期間第〇週至恢復期間終了，爲不影響評價，禁止過度的運 · 動、飮食、酒精及抽煙等生活習慣，另外，亦不進行降低 · 血壓用之治療或投藥。 (3 )檢查程序 -10- (7) (7)1335802 其次，如表1所示之檢查項目中，循環器官檢查及診察係於攝取開始前第〇週（攝取第〇日）至攝取最終週之第8週之隔週，以及後續恢復最終週（第4週）之第12 週進行。另外，體格、一般血液檢查、血液生化學檢查、脂質相關檢查及尿液檢查係於第0週、第4週及第8週進行。另外，該程序中所謂“週”係指攝取第0日起之每7 曰。 (4 )檢查項目檢查項目，如下所述。 [體格]:身長、體重、體脂肪、BMI (體格指數）、 [循環器換查]:收縮壓及舒張壓、心跳數、 [—般血液檢查]:紅血球數（RBC )、白血球數 (WBC )、血小板數、血色素量（Hb )、血球容積値 (Hematocrite，Ht)、各種白血球比例、 [血液生化學檢查]:總蛋白質、白蛋白、總膽色素、GOT (血淸天門冬氨酸轉化）値、GPT (血淸氨基丙酮酸轉化）値、ALP (鹼性磷脂晦）、LDH (乳脫氫酵素）、r 一 GTP ( r-麩氨酸轉化）、UA (尿酸）、：BUN (尿素氮）、GLU (空腹時血糖）、HbAlc (糖化血紅素 A1C) 及 1，5 — AG( 1,5-anhydro-D-glucitol)、肌酸內醯胺' 鈉、氯、鉀、鈣、磷、鐵、 [月旨質相關檢查]:總膽固醇（T 一 cho) 、TG (三酸甘油脂）、LDL — cho (低密度脂蛋白膽固醇）、HDL — cho -11 - (8) (8)1335802 (高密度脂蛋白膽固醇）、游離脂肪酸、磷脂質、 [尿檢查]:尿糖、尿蛋白、尿膽素原（Urobilinogen)、沈澱物（尿蛋白陽性時）； [診察]:副作用（問診及檢查値之異常）等。表2中係表示於攝取第0週，30名檢查結果之平均値±標準偏差。1335802 (1) Description of the Invention [Technical Field of the Invention] - Technical Field of the Invention The present invention relates to foods and medicaments containing royal jelly. [Prior Art] Royal jelly secreted by the pharyngeal glands of bees is known to have various pharmacological effects such as antibacterial action, inhibition of diabetes, increase of blood flow, promotion of growth and inhibition of arteriosclerosis, and is widely used in nutritional supplement foods and cosmetics. And external medicine for the Ministry of Medicine. In particular, it is considered as a nourishing and strong nourishing agent, and it is used as a nutritional supplement for weak physical and physical fatigue. The above-mentioned effective ingredients for pharmacological action were confirmed to contain 10-hydroxy-2-nonenoic acid (hereinafter referred to as "10-HDA"), acetylcholine, vitamin B group, nicotinic acid and pantothenic acid. In order to obtain a more effective pharmacological action, the active ingredient is administered to a person who is isolated, extracted, and transformed. For example, Japanese Patent Publication No. Hei 4-279597 discloses the decomposition of royal jelly into a peptide by an enzyme. Further, Japanese Laid-Open Patent Publication No. Hei No. Hei-4-3 1 1 3 5 7 discloses a method for producing a royal jelly extract having a high fatty acid content such as 10-HAD. In addition, Japanese Patent Publication No. 9-6U52 discloses a high-pressure protein-converting enzyme inhibitor (hypotension normalization) containing an active ingredient contained in royal jelly, and a trans- 1 hydroxy-hydroxy group having an action of insulin (anti-diabetic action). 2-decenoic acid. However, the blood pressure lowering action is administered to a mouse or a rat, and it is confirmed that the enzyme inhibiting activity of the action is confirmed by the above-mentioned Japanese Patent Publication No. Hei 4-279W7 and JP-A No. Hei. . In addition, the toxicity was also confirmed using mice. In other words, it has not been artificially ingested, and it is actually confirmed that the blood pressure lowering effect is not caused, and the range of safe intake which does not cause side effects such as poor digestion due to oral ingestion and decreased liver function is not unreasonable. The present invention has been made in view of the above problems, and provides a safe food and a medicament for ingesting royal jelly orally, and improving symptoms such as hypertensive disorder and shoulder muscle aches or headaches, and which do not cause side effects. DISCLOSURE OF THE INVENTION In other words, the i-th feature of the present invention is a food containing royal jelly in which a daily oral intake of royal jelly is converted into a suitable upper limit of llg in raw royal jelly. Here, the food containing royal jelly of the present invention has no side effects, and has a suitable form in which the amount of the royal jelly is 4 to 11 g in terms of raw royal jelly, and the treated state of the royal jelly is dried by raw royal jelly or freeze-dried raw royal jelly. Any of the royal jelly is suitable. The second feature of the present invention is a medicament containing royal jelly as a main component, and the daily oral dose of royal jelly is an agent having a blood pressure lowering effect in which the raw royal jelly is converted into an upper limit of llg. The third feature of the present invention is any of the above-mentioned foods and medicines containing royal jelly as a main component, and the daily oral dose of royal jelly is reduced to llg by the raw bee king-6-(3) 1335802 pulp. The agent of action. The best form for carrying out the invention. The royal jelly in the present invention generally contains about 66% by weight of water and about 11 to 13% of protein in untreated royal jelly (hereinafter, raw royal jelly). The lipid is about 5 to 10%, with his inorganic matter and the like. The various active ingredients in royal jelly are easily changed by light, heat and oxygen. Therefore, after the raw royal jelly is taken, the water can be removed by drying without damaging the active ingredients, and can be made into a dry royal jelly form. In the present invention, the treatment form of royal jelly is raw royal jelly, dried bee or both, and since it is suitable for ingesting all the components (except for the remainder) which are originally contained, it is suitable, and thus various components can be obtained by pharmacological action. In addition, the raw king bee paddle or the dried royal jelly may be subjected to solubilization treatment of insoluble property and heat treatment for improving oxidation resistance, etc., but the separation and extraction of specific active ingredients are not performed, for the reason that the above-mentioned suitable phase is suitable. By taking the pharmacological action, it is also possible to suppress an increase in the price of the treated product due to various places. The food containing royal jelly of the present invention has an upper limit of the intake of royal jelly in terms of raw royal jelly, and is preferably from 4 to 11 g, preferably from 4 to 11 g, and preferably from 5 to 11 g. The above-mentioned oral intake is higher than that of the conventional royal jelly, and the former is in a large amount, and is a safe intake amount which does not cause side effects. It is called I 67 and its quality, and the lyophilized royal jelly is the phase protein of water. Because it is reasonable, compared with (4) (4) 1335802, the appropriate type of daily oral intake, for example, When the royal jelly-containing food is ingested one or two times, the royal jelly is converted into raw food royal jelly, and the maximum amount of the food is 5.5 g (for example, 4.5 g). The above-mentioned food is a serving unit of one serving, which is formed or packaged. The number of molded articles or packages for the food unit of the above-mentioned one-times is preferably one, but it may be divided into two or more edible pieces. In addition, the number of intakes per day can be taken once or twice or more, and there is no particular limitation. Examples of the molded product of the food include a block and an ingot (a tablet), and the like, for example, a bag, a plastic cup, a bottle, a can, a capsule, and the like. The specific food type, for example, the first serving is a granulated powder enclosed in one bag, the first serving is a jelly filled in two cups or the amount of one serving is 20 tablets, etc." During the period, although the content of personal difference or pharmacological action is different, it is better to continue for 8 weeks. In addition, the soy taste which is peculiar to the singularity of the singularity of the singularity of the scented scented scented scented scented scented scented scented scented scented scented food. Royal jelly can be used as an agent having a blood pressure lowering effect. In other words, the agent according to the second aspect of the present invention contains royal jelly as a main component, and the daily oral intake is converted to the upper limit of llg in raw royal jelly, and has a blood pressure lowering effect. The royal jelly-containing food of the present invention described above can also be used for a medicament. In other words, the pharmaceutical composition according to the third aspect of the present invention contains the food of the present invention as a main component and has a blood pressure lowering action. -8- (5) (5) 1335802 The pharmaceutical agent of the present invention is obtained by, for example, using the food of the present invention as a main component and co-formulation with various carriers for oral administration. The carrier may, for example, be a flavoring agent, a binder, an excipient, a slip agent or the like. Further, the dosage form of the medicament may be any of a powder, a liquid, a tablet, a capsule, or the like. - The agent of the present invention has various pharmacological effects on symptoms such as shoulder muscle aches and headaches, in addition to a blood pressure lowering agent. And even if it is administered, there is no side effect such as diarrhea, liver obstruction and diabetes. _ The daily oral intake of the agent of the present invention may be the upper limit of 1 1 g in terms of raw royal jelly, preferably 2 to 1 1 g, preferably 4 to 1 1 g, and most preferably 5 to 1 1 g. it is good. The suitable period of administration of the agent of the present invention is the same as the period of ingestion of the above-mentioned food. [Embodiment] The present invention will be described in more detail by way of examples, but the invention is not limited thereto. In addition, the dried royal jelly used in the following examples was prepared as a jelly-dried powder (hereinafter referred to as FD powder) manufactured by JRJ Pharmaceutical Co., Ltd. This is a pale yellow powder obtained by freeze-drying raw royal jelly. · Example (Example 1) -9- (6) (6) 1365802 (1) Subject satisfies 1 ingestible royal jelly FD powder, no allergic reaction and severe underlying diseases, 2 with systolic blood pressure of 140 to 159 mmHg or diastolic The pressure is any one of 90 to 99Hg, and the age of 3 is about 30 to 50 years old, and the highest is 65 years old. After fully explaining the purpose and method of the clinical trial, 30 adults (8 males and 22 females) who agreed to participate in the trial were agreed. The age ranged from 35 to 64 years, with an average of 50.3 years and a standard deviation of 8.6 years. The above three subjects were randomly divided into 15 groups of Group A and Group B. In addition, the above 30 patients did not find any abnormalities (liver, heart, diabetes, etc.) other than blood pressure before the start of ingestion ( 2) The ingestion method implementation system includes a pre-observation period of 2 weeks, an ingestion period of 8 weeks, and a follow-up observation period of 4 weeks (recovery period). · l.8g of the above FD powder (equivalent to 5.4g of raw royal jelly)' to make group A i day:! Times, group B, 2 times a day, oral intake. The time of ingestion is determined by the individual and there are no special restrictions. In addition, during the period from the third week of the pre-observation period to the end of the recovery period, it is not affected by the evaluation, and excessive living habits such as transportation, food, alcohol, and smoking are prohibited. In addition, the blood pressure is not treated or administered. (3) Examination procedure-10- (7) (7) 1365802 Secondly, in the examination items shown in Table 1, the circulatory examination and examination are performed on the third week before the start of ingestion (the first day of ingestion) to the final week of ingestion. The week after the 8th week and the 12th week of the subsequent recovery of the final week (4th week). In addition, physique, general blood test, blood biochemical test, lipid-related test, and urine test were performed at week 0, week 4, and week 8. In addition, the term "week" in the program means every 7 起 from the 0th day of ingestion. (4) Inspection items Inspection items are as follows. [Physique]: body length, body weight, body fat, BMI (physical index), [circulator change]: systolic and diastolic blood pressure, heart rate, [------------- ), platelet count, hemoglobin (Hb), hematocrit (Ht), various white blood cell ratios, [blood biochemical examination]: total protein, albumin, total bile pigment, GOT (blood aspartate conversion)値, GPT (blood guanidine aminopyruvate conversion) 値, ALP (alkaline phospholipid 晦), LDH (milk dehydrogenase), r-GTP (r-glutamate conversion), UA (uric acid), :BUN ( Urea nitrogen), GLU (fasting blood glucose), HbAlc (glycosylated heme A1C) and 1,5 - AG (1,5-anhydro-D-glucitol), creatine lactam 'sodium, chlorine, potassium, calcium, Phosphorus, iron, and related tests: total cholesterol (T-cho), TG (triglyceride), LDL-cho (low-density lipoprotein cholesterol), HDL — cho -11 - (8) (8 1333802 (high-density lipoprotein cholesterol), free fatty acids, phospholipids, [urine test]: urine sugar, urine protein, urobilinogen (Urobilinogen), Precipitate (when positive urine protein); [examination]: side (the exception interrogation and check Zhi) and the like. Table 2 shows the mean 値± standard deviation of 30 test results at the 0th week of ingestion.

-12 - 1335802 Ο) 表1 項目/時期（週）攝取期間（8週） 0週1週2週3週4週5週6週7週8週恢復期間 (4週） 12週 [體格指數測量] 身長、體重、體脂肪率(B1法）〇〇〇 [循環器官檢查] 血壓、心跳數〇〇〇〇〇〇 [血液生化學檢查•脂質相關檢查] 總蛋白、白蛋白、總膽色素、GOT 、GPT、AL-P、LDH、7 -GTP、 TG、T-cho、LDL-cho、HDL-cho、游離脂肪酸、磷脂質、UA、BUN、 GLU(空腹時血糖、HbAlc、1.5AG 、肌酸內醯胺、Na、α、K、Ca、P 〇〇〇 [血液一般檢查] WBC、RBC、Hb、Ht、血/J顺、白血球比例(嗜中性球、嗜伊紅球、嗜鹼性球、淋巴球、單核球）〇〇〇 [尿液檢查] 糖、蛋白、沈激物(尿蛋白陽性時實施）〇〇〇 [診察] 副作用等〇〇〇〇〇-12 - 1335802 Ο) Table 1 Item/Period (Week) Intake period (8 weeks) 0 weeks 1 week 2 weeks 3 weeks 4 weeks 5 weeks 6 weeks 7 weeks 8 weeks recovery period (4 weeks) 12 weeks [Physique index measurement Body length, body weight, body fat percentage (B1 method) 〇〇〇 [Circulatory organ examination] Blood pressure, heart rate 〇〇〇〇〇〇 [blood biochemical examination • lipid-related examination] Total protein, albumin, total biliary pigment, GOT, GPT, AL-P, LDH, 7-GTP, TG, T-cho, LDL-cho, HDL-cho, free fatty acids, phospholipids, UA, BUN, GLU (fasting blood glucose, HbAlc, 1.5AG, muscle) Acid indoleamine, Na, α, K, Ca, P 〇〇〇 [General blood examination] WBC, RBC, Hb, Ht, blood / J cis, white blood cell ratio (neutrophil, eosinophil, alkalophilic Sex ball, lymphocyte, mononuclear ball) 〇〇〇 [Urine test] Sugar, protein, and stimuli (implemented when urine protein is positive) 〇〇〇 [Clinical] Side effects, etc. 〇〇〇〇〇

-13- (10)1335802 表2 性別（男/女） 8/22 年（歲） 50.3± 8.6 身長（cm) 1 60.5 ± 9.3 體重（kg) 6 1 .0± 12.0 BMI 23.7± 4.3 體脂肪率（％) 25.4± 5.5 收縮壓（mmHg) 144.8± 4.9 舒張壓（mmHg) 87.0± 5.3 脈搏（回/分） 79.2± 8.6 總蛋白（g /dl) 7 . 1 ± 0.6 白蛋白（S /dl) 4.3± 0.5 總膽色素（IU /1) 0.5± 0.2 GOT(IU /1) 22. 1± 8.5 GPT (IU /1) 22.6± 19.7 AL-P(IU /1) 245.5土 93.5 r -gtp(iu /1) 28. 1土 19.3 LDH(IU /1) 3 3 8.3 ± 77.0 t-cho(mg /dl) 134.2± 97.2 TG(mg /dl) 204.2± 28.8 LDL-cho(mg /dl) 105.1± 41.8 HDL-cho(mg /dl) 63.0± 1 8. 1 游磷脂肪酸（mEq /1) 0.6± 0.3 磷脂質（mEq /1) 227.8± 29.1 UA(mg /dl) 5 . 1 ± 1.6 BUN(mg /dl) 1 3 .3± 3.0 空腹時血糖（mS /dl) 99.9± 28.4 Hb Alc(%) 4.8± 0.7 l，5AG(“g /dl) 20.8± 8.3 肌酸內醯胺（mg /dl) 0.7± 0.2 Na(mEq /1) 142.2± 2.0 Cl(mEq /1) 103.3土 2.3 K(mEq /1) 4.2± 0.4 Ca(mEq /1 · mg /dl) 6. 1± 2.1 P(mEq /1) 3.4± 0.5 Fe( pg /dl) 87.7± 29.0 WBCUl) 6400.0土 1414.9 RBC(x 104 /μΐ) 453.1± 41.5 Hb(g /dl) 1 3 . 6± 1.9 Ht(%) 4 1 . 3 ± 4.8 血小板（x l〇4 /μΐ) 26.0± 4.8 白血球中嗜中性球比例；（％) 55.9± 8.5 白血球中嗜伊紅球比例；（％) 2.4± 1 .8 白血球中嗜鹼性球比例；（％) 0.9± 0.8 白血球中淋巴球比例；（％) 35.9± 7.2 白血球中單核球比例；（％) 4.7± 1.8 -14- (11) (11)1335802 (5)結果及檢定方法表3及表4係表示A組及B組之檢查結果之平均値土標準偏差。表4係表示，各被試驗者之收縮壓及舒張壓之各檢查値及各組之平均値及標準偏差。另外，圖1至圖8 係分別表示收縮壓、舒張壓、GOT、GPT、r — GPT、總膽固醇、中性脂肪（TG )及HDL -膽固醇之平均値及標準偏差之變化。圖1至圖8中，#爲A組之平均値，〇爲B組之平均値，標準偏差範圍（Error bar )爲標準偏差 X 1 0 另外，攝取期〇週至8週之各週統計學上差異的檢定係依據 Student’ s paired t-test (配對樣本的 t 檢定），而2組間之檢定係依據Fisher PLSD (多重比較法），進行偏差分析。兩檢定中之顯著水準（significance 1 e v e 1)爲 5 %。圖1及圖2中’ #係表示P<〇.〇5，##係表示p< 0.01(對 A 組）’ *係表示 P<〇.〇5、**係表示 ρ<〇.〇1’ ***係表示ρ<0.001(對〇週）。 1335802 εm ffl 8週後 65.7± 12.2 24.8± 5.0 26.1± 6.8 133.0± 5.0 氺氺氺 82.0± 6.4 氺氺* 73.8± 5.9* 〇 +1 卜 4.4± 0.5 0.5± 0.2 22.1± 7.2 22.2+ 16.6 259.4± 119.3 | 36.0± 33.4 356.7± 59_3 199.7± 25.6 114.9± 62.3 104.6± 26.8 61.4± 20.5 0.7± 0.4 218.0± 7.0 4週後 66.1± 11.9 25.0± 4.9 25.8+ .0 136.3± 6.7 氺氺木 1 85.0± 7.3* 74.6± 6.3* 7.1± 0.7 4.3± 0.6 0.5± 0.2 21.6± 5.9 22.5± 17.9 267.5± 106.8 32.9± 27.7 370.9± 72.1 207.9± 31.1 132.1± 114.4 105.8± 35.4 61.9± 24.1 0.6± 0.3 226.9± 35.4 開始時 66.1+ 12.0 25.0± 5.0 25.6± 7.0 144.7± 4.8 1_ 87.9± 6.3 78.9± 8.3 7.0土 0.6 4.4± 0.5 0.5± 0.2 20.9± 6.5 23.2± 23.2 265.5+ 110.1 31.9± 21.4 356.3± 76.8 207.0± 32.0 126.8± 76.4 109.5± 45.1 60.6± 18.7 0.6土 0.3 224.3± 27.4 f 8週後 55.6± 9.9* 22.3± 3.1 25.0土 3.7 136.6± 5.3 氺氺氺 78.6± 8.1 氺氺 78.0± 6.0 7.3± 0.3 4.2+ .5 0.6± 0.2 25.5± 9.9 24.5± 15.9 224.5+ 44.8 24.5± 15.9 318.0± 82.5 206.1± 28.3 152.8± 112.2 95.8± 35.5 63.7± 18.1 0.4± 0.3 225.4+ 33.3 4週後 58.0± 9.9 22.4± 3.1 24.8± 3.7 141.9+ 5.1 丨 80.4± 8.0* 1_ 77.5± 6.3 7.3± 0.5 4.1± 0.5 0.6± 0.2 24.2± 9.0 23.8± 17.6 223.1± 58.9 24.7± 15.7 326.1± 83.7 203.1± 27.2 143.9± 112.2 99.5+ 38.6 66.0+ 18.0 0.4± 0.2 226.2± 30.3 開始時 55.9± 9.9 22.4± 3.1 25.1± 3.6 144.9± 5.1 86.0± 4.1 i_ 79.5± 9.2 7.3± 0.5 4.2± 0.5 0.5± 0.2 23.3± 10.2 21.9± 16.1 225.5± 71.4 24.3± 16.8 320.3± 75.5 201.3+ 26.0 141.7± 116.7 100.7± 39.3 65.5± 17.8 0.5± 0.2 231.3± 31.3 檢查項目體重(kg) BMI 體脂肪率(％) 收縮壓(mmHg) 舒張壓(mmHg) 脈搏(回/分）總蛋白(g/dl) 白蛋白(g/dl) 總膽色素(IU/1) GOT(rU /1) GPT(IU /1) AL-P(IU /1) γ -GPT(IU /1) LDH(IU /1) t-cho(mg /dl) TG(mg /dl) LDL-cho(mg /dl) HDL-cho(mg /dl) 游離脂肪酸(mEq /1) 磷脂質(mg /dl) 盤鋇!!…looovd:* ,ιο.ονΡΗ** ' soovd* SI=U_ 擊if®+l®}哲Kl·-13- (10)1335802 Table 2 Gender (male/female) 8/22 years (years) 50.3± 8.6 Length (cm) 1 60.5 ± 9.3 Weight (kg) 6 1 .0± 12.0 BMI 23.7± 4.3 Body fat percentage (%) 25.4 ± 5.5 Systolic blood pressure (mmHg) 144.8 ± 4.9 Diastolic blood pressure (mmHg) 87.0 ± 5.3 Pulse (return / min) 79.2 ± 8.6 Total protein (g / dl) 7. 1 ± 0.6 Albumin (S / dl) 4.3± 0.5 total biliary pigment (IU /1) 0.5± 0.2 GOT (IU /1) 22. 1± 8.5 GPT (IU /1) 22.6± 19.7 AL-P(IU /1) 245.5 soil 93.5 r -gtp(iu /1) 28. 1 soil 19.3 LDH (IU /1) 3 3 8.3 ± 77.0 t-cho (mg / dl) 134.2 ± 97.2 TG (mg / dl) 204.2 ± 28.8 LDL-cho (mg / dl) 105.1 ± 41.8 HDL-cho (mg / dl) 63.0 ± 1 8. 1 Phosphorus fatty acid (mEq /1) 0.6 ± 0.3 Phospholipid (mEq /1) 227.8 ± 29.1 UA (mg / dl) 5. 1 ± 1.6 BUN (mg / Dl) 1 3 .3± 3.0 Fasting blood glucose (mS / dl) 99.9 ± 28.4 Hb Alc (%) 4.8 ± 0.7 l, 5AG ("g / dl) 20.8 ± 8.3 Creatine lactam (mg / dl) 0.7 ± 0.2 Na(mEq /1) 142.2± 2.0 Cl(mEq /1) 103.3 soil 2.3 K(mEq /1) 4.2± 0.4 Ca(mEq /1 · mg /dl) 6. 1± 2.1 P(mEq /1) 3.4 ± 0.5 Fe( pg /dl) 87 .7± 29.0 WBCUl) 6400.0 soil 1414.9 RBC(x 104 /μΐ) 453.1± 41.5 Hb(g /dl) 1 3 . 6± 1.9 Ht(%) 4 1 . 3 ± 4.8 Platelets (xl〇4 /μΐ) 26.0 ± 4.8 proportion of neutrophils in white blood cells; (%) 55.9 ± 8.5 proportion of eosinophils in white blood cells; (%) 2.4 ± 1.8 ratio of basophils in white blood cells; (%) 0.9 ± 0.8 lymphocytes in white blood cells Proportion; (%) 35.9 ± 7.2 ratio of mononuclear spheres in white blood cells; (%) 4.7 ± 1.8 -14- (11) (11) 1335802 (5) Results and verification methods Tables 3 and 4 indicate groups A and B The average soil standard deviation of the inspection results. Table 4 shows the average enthalpy and standard deviation of each test systolic and diastolic blood pressure of each subject and each group. In addition, Fig. 1 to Fig. 8 show changes in the mean enthalpy and standard deviation of systolic blood pressure, diastolic blood pressure, GOT, GPT, r-GPT, total cholesterol, neutral fat (TG), and HDL-cholesterol, respectively. In Fig. 1 to Fig. 8, # is the average 値 of group A, 〇 is the average 値 of group B, and the standard deviation range (Error bar) is the standard deviation X 1 0. In addition, the statistical difference between weeks of the ingestion period and weeks of 8 weeks The test was based on Student's paired t-test, and the test between the two groups was based on Fisher PLSD (Multiple Comparison). The significant level (significance 1 e v e 1) in the two tests is 5%. In Fig. 1 and Fig. 2, the ## indicates P<〇.〇5, ## indicates p<0.01 (for group A)' * indicates that P<〇.〇5, ** indicates ρ<〇.〇1 '*** indicates ρ < 0.001 (for week). 1335802 εm ffl After 8 weeks 65.7± 12.2 24.8± 5.0 26.1± 6.8 133.0± 5.0 氺氺氺82.0± 6.4 氺氺* 73.8± 5.9* 〇+1 4.4±0.5 0.5± 0.2 22.1± 7.2 22.2+ 16.6 259.4± 119.3 36.0± 33.4 356.7± 59_3 199.7± 25.6 114.9± 62.3 104.6± 26.8 61.4± 20.5 0.7± 0.4 218.0± 7.0 4 weeks later 66.1± 11.9 25.0± 4.9 25.8+ .0 136.3± 6.7 eucalyptus 1 85.0± 7.3* 74.6 ± 6.3* 7.1 ± 0.7 4.3 ± 0.6 0.5 ± 0.2 21.6 ± 5.9 22.5 ± 17.9 267.5 ± 106.8 32.9 ± 27.7 370.9 ± 72.1 207.9 ± 31.1 132.1 ± 114.4 105.8 ± 35.4 61.9 ± 24.1 0.6 ± 0.3 226.9 ± 35.4 66.1 + 12.0 at the beginning 25.0± 5.0 25.6± 7.0 144.7± 4.8 1_ 87.9± 6.3 78.9± 8.3 7.0 soil 0.6 4.4± 0.5 0.5± 0.2 20.9± 6.5 23.2± 23.2 265.5+ 110.1 31.9± 21.4 356.3± 76.8 207.0± 32.0 126.8± 76.4 109.5± 45.1 60.6 ± 18.7 0.6 soil 0.3 224.3 ± 27.4 f after 8 weeks 55.6 ± 9.9* 22.3 ± 3.1 25.0 soil 3.7 136.6 ± 5.3 氺氺氺 78.6 ± 8.1 氺氺 78.0 ± 6.0 7.3 ± 0.3 4.2 + .5 0.6 ± 0.2 25.5 ± 9.9 24.5 ± 15.9 224.5+ 44.8 24.5± 15.9 318.0± 82.5 206.1± 28.3 152.8± 112.2 95.8 ± 35.5 63.7± 18.1 0.4± 0.3 225.4+ 33.3 5 weeks after 4 weeks ± 9.9 22.4 ± 3.1 24.8 ± 3.7 141.9 + 5.1 丨 80.4 ± 8.0* 1_ 77.5 ± 6.3 7.3 ± 0.5 4.1 ± 0.5 0.6 ± 0.2 24.2 ± 9.0 23.8 ± 17.6 223.1± 58.9 24.7± 15.7 326.1± 83.7 203.1± 27.2 143.9± 112.2 99.5+ 38.6 66.0+ 18.0 0.4± 0.2 226.2± 30.3 55.9± 9.9 22.4± 3.1 25.1± 3.6 144.9± 5.1 86.0± 4.1 i_ 79.5± 9.2 7.3± 0.5 4.2± 0.5 0.5± 0.2 23.3± 10.2 21.9± 16.1 225.5± 71.4 24.3± 16.8 320.3± 75.5 201.3+ 26.0 141.7± 116.7 100.7± 39.3 65.5± 17.8 0.5± 0.2 231.3± 31.3 Check item weight (kg) BMI body fat percentage (%) Systolic blood pressure (mmHg) Diastolic blood pressure (mmHg) Pulse (return/min) Total protein (g/dl) Albumin (g/dl) Total biliary pigment (IU/1) GOT(rU /1) GPT (IU /1) AL-P(IU /1) γ -GPT(IU /1) LDH(IU /1) t-cho(mg /dl) TG(mg /dl) LDL-cho(mg /dl) HDL-cho (mg / dl) Free fatty acid (mEq /1) Phospholipid (mg / dl) 钡!!...looovd:* , ιο.ονΡΗ** ' soovd* SI=U_ 击 if®+l®}哲Kl·

-16- 1335802 寸m s 8週後〇 - in 12.9± 2.4 93.2± 11.9 4.9± 0.7 23.2± 11.4 0.7± 0.2 142.4± 2.3 103.0± 2.5 4.1± 0.5 5.9± 2.0 3.9± 0.7 91.8± 20.3 6710.0± 1492.9 456.7± 41.8 14.0± 1.9 41.6± 4.3 26.2± 5.0 54.2± 6.5 2.9± 1.9 1.0± 1.2* 38.1± 6.4 4.8± 1.0 4週後 in in 14.4± 3.6 94.1± 11.5 1_ d 寸· 23.6± 10.3 0.7± 0.2 142.5± 1.8 103.8± 2.5 寸 o 寸 | 5.8± 1.9 j 3.6± 0.6 | 90.7± 13.9 | 6812.7± 1599.4 45637± 41.4 13.8± 1.7 42.0± 4.4 25.2± 4.8 54.4± 8.6 3·7± 2.8 0.9± 1.0 35.8± 7.5 5.3± 1.6 開始時 5.4± 1.9 13.2± 2.9 97.0± 17.6 4.9± 0.7 23.3± 10.8 0.7± 0.2 142.4± 2.3 104.1± 2.4 4.1± 0.4 6.0± 2.3 3.7± 2.5 85.9± 21.4 6774.7土 1455.3 457.4± 39.6 vq -»—H 41.3± 3.8 25.8± 5.4 54.9± 9.3 2.8± 1.9 0.9± 1.0 35.6± 7.8 5.2± 2.0 f 8週後 5.0± 1.9 14.1± .4 97.6± 23.5 4.6± 0.5 19.3± 4.8 0.8± 0.2 141.6± 1.9 102.7± 2.2 4.3± 0.5 6.5± 2.2 3.3± 0.5 99.2± 43.2 6068.0± 1297.0 458.4± 40.1 O) ί—H 涅 rW t—H 42.4± 4.9 24.0± 3.6* 55.7± 9.8 2.2± 1.8 1.0± 0.7 36.7± 7.8 4.5± 2.3 4週後 4.7± 1.3 13.3± 2.5 95.5± 18.8 4.6± 0.5 18.3± 4.3 0.8± 0.1 141.8± 2.0 102.8 土 1.9 4.3± 0.5 6.4± 2.1 3.3± 0.6 91.4± 36.4 6190.7± 1092.4 453.2± 35.6 vq 1-H 45.1± 4.4 25.2± 4.0 57.7± 7.4 ϊ—Η 1.0土 0.7 35.0± 6.4 - 寸開始時寸 13.3± 3.2 102.7± 36.6 4.6± 0.6 18.4± 3.8 0.8± 0.2 141.9± 1.8 102.5± 2.0 4.3± 0.4 6.3± 2.1 3.2± 0.4 89.5± 35.7 6025.31 1314.5 448.8± 44.2 CN +1 寸 cn 1-H 41.4± 5.7 26.1± 4.3 56.8+ 7.8 1.9± 1.6 1.0± 0.5 36.1± 6.7 4.2± 1.6 檢查項目 UA( mg /dl) BUN( mg /dl) 空腹時血糖(mg/dl) HbAlc%) 1.5AG(pg /dl) 肌酸內醯胺（mg/dl) Na( mEq /1) C( mEq /1) K( mEq /1) Ca( mEq /1 · mg /dl) P( mg /dl) Fe( μ g / d 1) WBC( μ 1 ) /— X S Hb(g/dl) Ht( %) X g 七白血球中嗜中性球比例(％) 白血球中嗜伊紅球比例(％) 白血球中嗜驗性球比例(％) 白血球中淋巴球比例(％) 白血球中單核球比例(％) 盤遐sisyv ΙΟΟον,Ι:* , loovcu* , so.ovd* 擊if®+lM}^dz-16- 1335802 inch ms after 8 weeks 〇-in 12.9±2.4 93.2± 11.9 4.9±0.7 23.2± 11.4 0.7± 0.2 142.4± 2.3 103.0± 2.5 4.1± 0.5 5.9± 2.0 3.9± 0.7 91.8± 20.3 6710.0± 1492.9 456.7± 41.8 14.0± 1.9 41.6± 4.3 26.2± 5.0 54.2± 6.5 2.9± 1.9 1.0± 1.2* 38.1± 6.4 4.8± 1.0 After 4 weeks in in 14.4± 3.6 94.1± 11.5 1_d inch · 23.6± 10.3 0.7± 0.2 142.5± 1.8 103.8 ± 2.5 inches o inches | 5.8 ± 1.9 j 3.6 ± 0.6 | 90.7 ± 13.9 | 6812.7 ± 1599.4 45637 ± 41.4 13.8 ± 1.7 42.0 ± 4.4 25.2 ± 4.8 54.4 ± 8.6 3·7 ± 2.8 0.9 ± 1.0 35.8 ± 7.5 5.3 ± 1.6 At the beginning 5.4 ± 1.9 13.2 ± 2.9 97.0 ± 17.6 4.9 ± 0.7 23.3 ± 10.8 0.7 ± 0.2 142.4 ± 2.3 104.1 ± 2.4 4.1 ± 0.4 6.0 ± 2.3 3.7 ± 2.5 85.9 ± 21.4 6774.7 soil 1455.3 457.4 ± 39.6 vq -» -H 41.3± 3.8 25.8± 5.4 54.9± 9.3 2.8± 1.9 0.9± 1.0 35.6± 7.8 5.2± 2.0 f 5.0±8 after 8 weeks 14.1±.4 97.6± 23.5 4.6± 0.5 19.3± 4.8 0.8± 0.2 141.6± 1.9 102.7± 2.2 4.3± 0.5 6.5± 2.2 3.3± 0.5 99.2± 43.2 6068.0± 1297.0 458.4± 40.1 O) ί—H 涅 rW t—H 42.4± 4.9 24.0± 3.6* 55.7± 9.8 2.2± 1.8 1.0± 0.7 36.7± 7.8 4.5± 2.3 4 weeks later 4.7±1.3 13.3±2.5 95.5± 18.8 4.6± 0.5 18.3± 4.3 0.8± 0.1 141.8± 2.0 102.8 Soil 1.9 4.3± 0.5 6.4± 2.1 3.3 ± 0.6 91.4 ± 36.4 6190.7 ± 1092.4 453.2 ± 35.6 vq 1-H 45.1 ± 4.4 25.2 ± 4.0 57.7 ± 7.4 ϊ - Η 1.0 soil 0.7 35.0 ± 6.4 - inch at the beginning of the inch 13.3 ± 3.2 102.7 ± 36.6 4.6 ± 0.6 18.4 ± 3.8 0.8± 0.2 141.9± 1.8 102.5± 2.0 4.3± 0.4 6.3± 2.1 3.2± 0.4 89.5± 35.7 6025.31 1314.5 448.8± 44.2 CN +1 inch cn 1-H 41.4± 5.7 26.1± 4.3 56.8+ 7.8 1.9± 1.6 1.0± 0.5 36.1± 6.7 4.2± 1.6 Check item UA( mg /dl) BUN( mg /dl) Fasting blood glucose (mg/dl) HbAlc%) 1.5AG(pg /dl) Creatine lactam (mg/dl) Na( mEq /1) C( mEq /1) K( mEq /1) Ca( mEq /1 · mg /dl) P( mg /dl) Fe( μ g / d 1) WBC( μ 1 ) /— XS Hb( g/dl) Ht( %) X g Ratio of neutrophils in seven white blood cells (%) Proportion of eosinophils in white blood cells (%) Proportion of eosinophils in white blood cells (%) Lymphocyte ratio in white blood cells (%) White blood cells The proportion of single-nuclear spheres (%) 遐 yyv ΙΟΟον, Ι:*, Loovcu* , so.ovd* hit if®+lM}^dz

-17- 1335802 3 s in S 〇 ss o o V〇’ OS o g o t o \〇 ON o § o JO o CN 00 〇 00 Ο vg ο 佘 ο ο 00 ο 83.533 00 CN 卜 v〇 /-~N w: ! ij m o CN Ό o CN σ\ o o o CN 00 o § o o ^d 00 o p o CS o VO 00 q 00 o 度 q o (N oo o rsi 卜 I 78.733 Os CN 00 HI v〇 \Ti o s' p § 〇 JO o § o o § o r-* r- CO o o 卜 <N ο s' ο CS 00 ο CN· 00 ο § v〇 00 卜 g 00* CTE in o t o 00 00 o o § o CN 00 o <N 00 o p § o s o 00 o § cn VO 卜 <N o CS ON o 00 v〇 o o fM 00 is Os cn m μ o vd o § o 00* v〇 o (N 00 o t o g m 〇\ 卜 00* 00 p ?·Η 卜〇i 卜 ο CN ON ο CN 00 ο ο 00 ο (Ν 00 ro m 〇> ON 卜 CN 宕 VO* m rj o vd 00 o (N On o v〇 00 o s' o o 00 o VO o 00 00 o t o vd 00 o t d 00 o g m 00 o (N Os o o 00 〇> VO 00 <ri m o r4 v〇 o oo 〇 00 v〇 o \6 00 o o ύ cn co ss O <ri 00 o t^* ο ίΝ ο § ο ύ ο ο ri 00 P fn § 〇> Os Os 卜· m 00 <N o 00 00 o 〇\ o 00 00 o 00 o <N 00 o VO o § o § o 佘 o oo o Os m v〇 o g 〇\ 00 o oo o o o «η 00 00 cn m 卜· 冚〇 00 00 o CN 00 〇 o 00 00 o VO o 00 〇 m* Os m 〇\ 00 卜卜 jn 卜 wS ο § ο ο 00 00 ο ύ 寸· 00 寸 •Τ) On m o § o vd Os o 〇Ί· ON o VO 00 o v〇 00 o § o g o o fN Os o 00 00 CO vd 00 o vd 00 CO in* 00 m Os Os o 00 VO 卜 00 »〇卜· m O o vd 00 p § 〇 o On o 00 00 o g o 00* 00 m 〇< 00 卜 Ό* 00 m 00 00 cn S ο 〇\ ο ΐΝ σ> ο § ο 00* 00 ο CN 00 o o so 00 寸· QI o o o ON o o o 含 o § o vb 00 o rsi 00 o 00 00 o 佘 o m* Os o 00* 00 卜 ON 00 S5 o 00 00 o vd 00 o o 卜卜 ο 00 卜· 00 s <T) a 蹩 m S o cs 2 o 〇〇 0 01 ro o o’ o p 寸· o rs m i-H o fN CO o 00 2 ο 寸· m ο 寸· ο ο ο ο 00 m m ON 卜’ CO 00 00 卜 •Λ1* /^~s ox ! u 躍 m z o o o CN 寸 o m o 00* CN i-H p o 00* 2 o o p 寸· 2 o σ\ CN »—H o ΟΊ cn ϊ—H o i-H o o <> CO CO fO ON 汰 s cn c< m v〇 m o vd o o 00 2 o \6 C^i o CN CO ϊ—H o 00 cn ϊ—H m o' CO o σ< cs cn o 00 rs ο o’ 寸 ο ο ο ?; ο \ό m ο CN P in •ri m »r> o CN cn o SO* m o CO o SO* m o SO’ o <s m o ΙΛΪ 2 o <N m o t o H r—H 卜 o 00 <N o ON (N 卜 Η· o 06 <N Γ- s m" m 芝 o Ό* CQ q] o o o o o 00 c^i »-H 〇 00* 2 o ^d m p o 〇 rW cn cn ON 2 〇 v〇 m O 为卜 00* ΓΟ Ο ο ο ο ν〇 ^-Η ρ 寸· <N 卜· CO Os m ON i〇 m o CN m o cs CO o vd o 00 cn o 00 o m f-H o 卜· o m o o o 卜 00 m o m 寸 ο o <s m 寸 *n_ m CO 寸· m 00 (N 0 01 o 00 o 00 o d o 00 CO o 等· l> CM* in 〇· 卜 o — m 00 m — 〇 00 ΓΟ »—( ο ο ο ν〇 CO »·Η ο 寸二 m 5： 1-H CN \o o iri m 00 CN o 00 m o \b m o 00 m o o o 00 CO o cn «-Η o ri CN i-H o 00 CO o o o CO o Γ-^ 卜 \ό m 卜 qi o (N ΓΊ On iS VO 2 VO «〇 V〇 Ό* □I o 00 o o jn o o o 2 o cs m 〇卜〇\ 二 cn 寸· cn 00 卜 Ό* 卜 vd 二 ο 5· ο ο ο 00* 〇寸二卜 s m" ir> VO oo 寸 m 寸 1—^ o o o 00 m o o »—H o o p 寸· CO o 2 o <N ro o o r-H ro 二 o in o 卜 m o o 卜 o fS 2 cs On w-j m O o 00* 2 o i〇 o Os m o o o m (N 2 卜 P； o 卜 »〇 ο νο 2 ο CN 2 ο 00 2 ο VO 2 卜 V〇 00 g in* CQ o o o 00 o o 2 o \〇 2 o τ—H o o p 寸 o o Ό* 2 〇· 寸· p iri o o 2 卜 o o o m 卜寸· m 00 寸 [m M m g s il· 槲 Sf Liil 鐘 LLi © 螭 g 姻 -18- (15) 1335802 (6 )對血壓之效果上述30名被試驗者之初期血壓爲輕度至中度之高血壓者，其收縮壓平均値爲144.8±標準偏差4.9mmHg，其舒張壓平均値爲87.0土標準偏差5.3 mmHg。-17- 1335802 3 s in S 〇ss oo V〇' OS ogoto \〇ON o § o JO o CN 00 〇00 Ο vg ο 佘ο ο 00 ο 83.533 00 CN 卜v〇/-~N w: ! ij Mo CN Ό o CN σ\ ooo CN 00 o § oo ^d 00 opo CS o VO 00 q 00 o degrees qo (N oo o rsi 卜 I 78.733 Os CN 00 HI v〇\Ti os' p § 〇JO o § Oo § o r-* r- CO oo 卜<N ο s' ο CS 00 ο CN· 00 ο § v〇00 卜g 00* CTE in oto 00 00 oo § o CN 00 o <N 00 op § Oso 00 o § cn VO 卜<N o CS ON o 00 v〇oo fM 00 is Os cn m μ o vd o § o 00* v〇o (N 00 otogm 〇\ 00* 00 p ?·Η 卜〇i 卜ο CN ON ο CN 00 ο ο 00 ο (Ν 00 ro m 〇> ON 卜CN 宕VO* m rj o vd 00 o (N On ov〇00 os' oo 00 o VO o 00 00 oto vd 00 otd 00 ogm 00 o (N Os oo 00 〇> VO 00 <ri mo r4 v〇o oo 〇00 v〇o \6 00 oo ύ cn co ss O <ri 00 ot^* ο ίΝ ο § ο ύ ο ο ri 00 P fn § 〇> Os Os 卜 m 00 <N o 00 00 o 〇\ o 00 00 o 00 o <N 00 o VO o § o § o 佘o oo o Os mv 〇og 〇\ 00 o oo ooo «η 00 00 cn m 卜 00 00 o CN 00 〇o 00 00 o VO o 00 〇m* Os m 〇\ 00 卜卜 jn 卜 wS ο § ο ο 00 00 ο ύ 寸 · 00寸•Τ) On mo § o vd Os o 〇Ί· ON o VO 00 ov〇00 o § ogoo fN Os o 00 00 CO vd 00 o vd 00 CO in* 00 m Os Os o 00 VO 00 »〇卜· m O o vd 00 p § 〇o On o 00 00 ogo 00* 00 m 〇< 00 Ό Ό 00 00 00 cn S ο 〇 σ σ > ο § ο 00* 00 ο CN 00 oo so 00 inch · QI ooo ON ooo with o § o vb 00 o rsi 00 o 00 00 o 佘om* Os o 00* 00 卜 ON 00 S5 o 00 00 o vd 00 oo 卜 ο 00 00 00 s <T a 蹩m S o cs 2 o 〇〇0 01 ro o o' op 寸 · o rs m iH o fN CO o 00 2 ο 寸 · m ο 寸 · ο ο ο ο 00 00 mm ON 卜 ' CO 00 00 卜•Λ1* /^~s ox ! u 跃mzooo CN 寸 omo 00* CN iH po 00* 2 oop inch · 2 o σ\ CN »—H o ΟΊ cn ϊ—H o iH oo <> CO CO fO ON s cn c< mv〇mo vd oo 00 2 o \6 C^io CN CO ϊ—H o 00 cn ϊ—H mo' CO o σ< cs cn o 00 rs ο o' inch ο ο ο ?; ο \ό m ο CN P in • ri m »r> o CN cn o SO* mo CO o SO* mo SO' o <smo ΙΛΪ 2 o <N moto H r-H 卜o 00 &lt ;N o ON (N Η Η o 06 <N Γ- s m" m 芝 o Ό* CQ q] ooooo 00 c^i »-H 〇00* 2 o ^dmpo 〇rW cn cn ON 2 〇v 〇m O is 00* ΓΟ Ο ο ο ο ν〇^-Η ρ 寸 · <N 卜 · CO Os m ON i〇mo CN mo cs CO o vd o 00 cn o 00 om fH o 卜 omooo 00 mom ο o <sm inch*n_ m CO inch·m 00 (N 0 01 o 00 o 00 odo 00 CO o et al · l> CM* in 〇· 卜o — m 00 m — 〇00 ΓΟ »— ( ο ο ο ν〇CO »·Η ο 寸二 m 5: 1-H CN \oo iri m 00 CN o 00 mo \bmo 00 mooo 00 CO o cn «-Η o ri CN iH o 00 CO ooo CO o Γ-^ 卜\ό m 卜 o (N ΓΊ On iS VO 2 VO «〇V〇Ό* □I o 00 oo jn ooo 2 o cs m 〇卜〇\二cn inch·cn 00 卜Ό* Bud vd二ο 5· ο ο ο 00* 〇寸二卜 s m"ir> VO oo inch m inch 1—^ ooo 00 moo »—H oop inch · CO o 2 o <N ro oo rH ro two o in o卜 moo 卜o fS 2 cs On wj m O o 00* 2 oi〇o Os mooom (N 2 卜 P; o 卜 » 〇ο νο 2 ο CN 2 ο 00 2 ο VO 2 卜 V〇00 g in* CQ Ooo 00 oo 2 o \〇2 o τ-H oop inch oo Ό* 2 〇· inch·p iri oo 2 卜ooom 卜 inch·m 00 inch [m M mgs il· 槲Sf Liil clock LLi © 螭g marriage- 18- (15) 1335802 (6) Effect on blood pressure The initial blood pressure of the 30 subjects was mild to moderate hypertension, and the mean systolic blood pressure was 144.8± standard deviation 4.9 mmHg, and the diastolic blood pressure averaged.値 is 87.0 soil standard deviation 5.3 mmHg.

全部病例顯示攝取8週後，收縮壓及舒張壓均顯著地降低。A組之收縮壓由開始時（0週）之 144.9 土 5.1mmHg，降低至攝取終了時（8週）之136_6±5.3mmHg (p二0.0001)，舒張壓由開始時（0週）之 86.0 土 4.1mmHg，降低至攝取終了時（8週）之 78.6± 8.1 mmHg (p = 0.002 8 )。另外，B組之收縮壓由開始時（〇週）之 144.7± 4.8mmHg，降低至攝取終了時（8週）之 133.0土 5 .OmmHg ( p < 0.000 1 )，舒張壓由開始時（0週）之87.9 ± 6.3 mmHg，降低至攝取終了時（8週）之 82.0 土 6.4mmHg ( p = 0.0019) 〇All cases showed that systolic and diastolic blood pressures were significantly reduced after 8 weeks of ingestion. The systolic blood pressure of group A decreased from 144.9 soil 5.1mmHg at the beginning (0 weeks) to 136_6±5.3mmHg (p=0.0001) at the end of ingestion (8 weeks), and the diastolic pressure was 86.0 soil from the beginning (0 weeks). 4.1 mmHg was reduced to 78.6 ± 8.1 mmHg (p = 0.002 8 ) at the end of ingestion (8 weeks). In addition, the systolic blood pressure of group B decreased from 144.7 ± 4.8 mmHg at the beginning (week) to 133.0 soil at the end of ingestion (8 weeks), 5. OmmHg (p < 0.000 1 ), and diastolic pressure from the beginning (0 Week 8) ± 6.3 mmHg, reduced to 82.0 ± 6.4 mmHg at the end of ingestion (8 weeks) ( p = 0.0019) 〇

B組間之差異，關於收縮壓，b組比a組更有降低血壓作用（P<〇.〇〇〇1)。攝取終了後恢復期最終週之第1 2週，認爲A組之收縮壓及舒張壓均緩緩地恢復，認爲B組只恢復收縮壓，而舒張壓有些許降低的傾向。 (7)自覺症狀被試驗者’於生活調查單上，記錄飮食、酒精及咖啡的攝取及運動等記錄。主治醫師除了依上述程序之各種檢查外，於攝取第〇週、第4週及第8週之診察時，確認服 -19- (16) 1335802 用狀況，依據診察及上述生活調查單，判定自覺症狀。判定係依據圖9所示之疲勞感、暈眩、手腳浮腫等19個項目之自覺症狀，以表6所示之5階段判定方法進行。其次’比較攝取第0週及第8週之症狀，依據表7所示之改善判定基準’判定對於改善症狀之評價。另外’於實施期間中發現新症狀時，臨床上不適合者爲伴隨症狀’其中不能否定與FD粉末有因果關係者爲副作用’可以明確否定者則以偶發症狀處理。鲁表6The difference between group B, with regard to systolic blood pressure, group b has a lower blood pressure effect than group a (P<〇.〇〇〇1). At the end of the first week of the recovery period after the end of ingestion, it was considered that the contraction pressure and diastolic blood pressure of group A gradually recovered, and it was considered that group B only recovered systolic blood pressure, and the diastolic blood pressure slightly decreased. (7) Conscious symptoms The subjects were recorded on the life survey form to record the intake and movement of foraging, alcohol and coffee. In addition to the various tests in the above procedures, the attending physician confirms the use of the -19-(16) 1335802 at the time of the second week, the fourth week and the eighth week of the examination, and judges the conscious based on the examination and the above-mentioned life survey form. symptom. The judgment was based on the five-stage judgment method shown in Table 6 based on the symptoms of fatigue such as fatigue, dizziness, and edema of the hands and feet shown in Fig. 9. The next time, the symptoms of the 0th week and the 8th week were compared, and the evaluation of the symptoms was judged based on the improvement criterion shown in Table 7. In addition, when a new symptom is found during the implementation period, the clinically unsuitable person is the accompanying symptom, in which the causal relationship with the FD powder cannot be denied as a side effect, and the person who is clearly negative can be treated with sporadic symptoms. Lu Table 6

程度自覺症狀之評價方法 3 + :高度症狀認爲有高度症狀。例如，感覺非常疲憊，無法工作及學習。 2+ :中度症狀認爲有中度症狀。例如，感覺疲憊無力。 + :輕度症狀認爲有輕度症狀。例如，感覺有此疲憊，佝並不在意。 ± :輕微的症狀認爲有輕微的症狀。例如，覺得有點疲憊，佝可忍耐。 -:無症狀幾乎完全沒有症狀，或沒有感覺。 -20- (17) 1335802Degree Evaluation method of self-conscious symptoms 3 + : High symptoms It is considered to have high symptoms. For example, I feel very tired and unable to work and learn. 2+ : Moderate symptoms are considered moderate. For example, feeling tired and weak. + : Mild symptoms are considered mild. For example, if you feel tired, you don't care. ± : Slight symptoms are considered mild. For example, I feel a little tired and can't stand it. -: Asymptomatic There is almost no symptoms at all, or no feeling. -20- (17) 1335802

評價I 自覺症狀之判定基準 1 .明顯改善 3+— + 2.改善 3+—>2+， 2 + —>+， +_>十，士一》- 3 .不變 3+— 3+，2 + — 2+，+— + 4 .惡化 2 + 一3+，+->2 +或 3+，-一+或 2 +或 3 + 5.無症狀 —--> — 6 .無法判定攝取試驗食品之前後評價中之任何一項，或兩項。Evaluation criteria for the judgment of I self-consciousness 1. Significant improvement 3+- + 2. Improvement 3+->2+, 2 +->+, +_>10, Shiyi--3. Unchanged 3+-3 +, 2 + — 2+, +— + 4. Deterioration 2 + a 3+, +-> 2 + or 3+, - one + or 2 + or 3 + 5. asymptomatic ---> — 6 It is not possible to determine any one of the pre- and post-evaluation of the test food, or two.

上述改善評價1至4者爲有症狀者，其中以明顯改善 (改善評價1 )及改善（改善評價2 )者之比率作爲自覺症狀改善率（％)，所算出結果如圖9所示。由圖9可知，全部19個項目中之15個項目顯示50%以上之自覺症狀改善率。另外，血壓以外之循環器官檢查 '體格、一般血液檢查、血液生化學檢查、脂質相關檢查及尿液檢查之結果，於實施期間中之變動均於正常範圍內。另外，認爲攝取中未呈現身體症狀等之伴隨症狀，認爲實施期間中未有任何副作用及偶發症。 (8 )倫理委員會之承認及告知後同意（informed consent ) -21 - (18) (18)1335802 本實施例係於磯子中央腦神經外科病院健康管理中心倫理委員會之承認下進行。對於被試驗者，關於硏究內容及方法等，進行充份的說明，並以文書交換取得告知後同 ztfn 思 ° (實施例2 ) 依照下述所示處方，製成顆粒及錠劑。亦即，將下述處方成份於流動層下混合，噴霧5 0 %乙醇水溶液，進行流動層造粒。接著，以4 0 °C之排氣溫度乾燥後，以2 4網目的篩子過篩。相對於100重量份之過篩物，加入0.4重量份之滑石及2重量份之蔗糖脂肪酸酯混合。由此混合物製成顆粒。另外，將上述混合物打錠，製成錠劑。〔處方〕 FD粉末：66.6重量份乳糖：20重量份結晶纖維素：5重量份玉米澱粉：4重量份羧甲基澱粉鈉：2重量份依據本發明，未出現腹瀉、肝臟阻礙及糖尿病等副作用，並可改善高血壓症及肩膀肌肉酸痛或頭痛等自覺症狀。另外，未將蜂王漿中之特定有效成份進行分離 '抽出及轉化處理，因此可得到蜂王漿原本所含有之全部成份之相乘藥理作用。 -22- (19) 1335802 【圖式簡單說明】第1圖係表示於實施例中，差之變化圖。第2圖係表示於實施例中，差之變化圖。第3圖係表示於實施例中差之變化圖。第4圖係表示於實施例中，之變化圖。第5圖係表示於實施例中，偏差之變化圖。第6圖係表示於實施例中，偏差之變化圖。第7圖係表示於實施例中値及標準偏差之變化圖。第8圖係表示於實施例中，標準偏差之變化圖。第9圖係表示於實施例中，中之明顯改善（改善評價1 )者之比率所算出爲自覺症狀改善率收縮壓之平均値及標準偏舒張壓之平均値及標準偏，G Ο T之平均値及標準偏 GPT之平均値及標準偏差 T — GPT之平均値及標準總膽固醇之平均値及標準，中性脂肪（τ G )之平均 HDL -膽固醇之平均値及以具有自覺症狀之症狀者 · 及改善（改善評價2)者 (% )圖。 · -23-The above-mentioned improvement evaluations 1 to 4 were symptomatic, and among them, the ratio of improvement (improvement of evaluation 1) and improvement (improvement of evaluation 2) was used as the conscious symptom improvement rate (%), and the calculated result is shown in Fig. 9. As can be seen from Figure 9, 15 of the 19 items showed a conscious improvement in symptoms of more than 50%. In addition, the results of the circulatory examinations other than blood pressure, physical fitness, general blood tests, blood biochemical tests, lipid-related tests, and urine tests were all within the normal range during the implementation period. In addition, it is considered that there is no accompanying symptom such as physical symptoms during the ingestion, and it is considered that there are no side effects and occasional symptoms during the implementation period. (8) Acknowledgment of the ethics committee and informed consent -21 - (18) (18)1335802 This example was carried out under the acknowledgment of the Ethics Committee of the Isogo Central Brain Neurosurgery Hospital Health Management Center. For the subjects to be tested, the contents and methods of the study were fully described, and after the notification was obtained by the exchange of documents, the tablets and tablets were prepared according to the following prescriptions in accordance with the following formula. Namely, the following prescription ingredients were mixed under a fluidized bed, and a 50% aqueous solution of ethanol was sprayed to carry out flow layer granulation. Subsequently, it was dried at a discharge temperature of 40 ° C and sieved through a sieve of 24 mesh. 0.4 parts by weight of talc and 2 parts by weight of sucrose fatty acid ester were mixed with respect to 100 parts by weight of the sieve. The mixture is thus granulated. Further, the above mixture was tableted to prepare a tablet. [Prescription] FD powder: 66.6 parts by weight of lactose: 20 parts by weight of crystalline cellulose: 5 parts by weight of corn starch: 4 parts by weight of sodium carboxymethyl starch: 2 parts by weight According to the present invention, side effects such as diarrhea, liver obstruction and diabetes are not observed It can also improve symptoms such as high blood pressure and shoulder muscle soreness or headache. In addition, the specific active ingredients in the royal jelly are not separated and extracted and converted, so that the multiplicative pharmacological effects of all the components contained in the royal jelly can be obtained. -22- (19) 1335802 [Simplified description of the drawings] Fig. 1 is a diagram showing changes in the difference in the embodiment. Fig. 2 is a graph showing the difference in the variation in the embodiment. Fig. 3 is a graph showing the variation of the difference in the embodiment. Fig. 4 is a diagram showing changes in the embodiment. Fig. 5 is a graph showing the variation of the deviation in the embodiment. Fig. 6 is a graph showing the variation of the deviation in the embodiment. Fig. 7 is a graph showing changes in enthalpy and standard deviation in the examples. Fig. 8 is a graph showing changes in standard deviation in the examples. Fig. 9 is a graph showing the ratio of the sensitivities of the conscious systolic blood pressure to the mean 値 systolic blood pressure and the standard eccentricity and the standard deviation of the standard eccentricity of the conscious systolic blood pressure improvement rate, G Ο T Mean 标准 and standard deviation GPT mean 标准 and standard deviation T — average mean 値 and standard total cholesterol G and standard, average fat DL of neutral fat (τ G ) and average symptoms of cholesterol And the improvement (improvement of evaluation 2) (%) chart. · -twenty three-

Claims

1335802 修正補充I 99.10. 13 乎月日拾、申請專利範圍 --- 第0921 04299號專利申請案中文申請專利範圍修正本民國99年10月13日修正 1. 一種使用於降低血壓之醫藥組成物，其特徵爲以蜂王漿爲主要成份者，其中蜂王漿之每日經口投予量係以生蜂王漿換算爲5.4〜10.8g。1335802 Amendment Supplement I 99.10. 13 Months of the day, the scope of application for patents --- Patent application No. 0921 04299 Patent application amendments of the Chinese patent application on October 13, 1999 1. A pharmaceutical composition for lowering blood pressure It is characterized in that royal jelly is the main component, and the daily oral dose of royal jelly is 5.4 to 10.8 g in terms of raw royal jelly.