TW200425902A - Novel herbal compositions and use thereof - Google Patents
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- TW200425902A TW200425902A TW92113808A TW92113808A TW200425902A TW 200425902 A TW200425902 A TW 200425902A TW 92113808 A TW92113808 A TW 92113808A TW 92113808 A TW92113808 A TW 92113808A TW 200425902 A TW200425902 A TW 200425902A
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Abstract
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200425902200425902
； ； .'：.；.;；' . .：'..S'λ'：..;- ν'-·，·.，:·:·^. 發明所屬之技術領域： 本發明係關於一種具植物性雌激素活性之組合物， 其是由數種中草藥原料依特定重量配比製成。該組合 物可減緩哺乳動物更年期症候群。 先前技術： 女性進入更年期後，超過一半以上的停經婦女會因 雌激素驟然下降，喪失對於心臟血管功能的保護及維 護，容易發生中風等心臟血管性疾病。也引發腦下垂 體促性腺激素不定時上升，造成周邊血管舒張功能不 穩定，而出現熱潮紅、頭痛、臊酸背痛、頸部不舒服、 失眠、盜汗或是情緒不穩的#狀。也會使陰道表皮組 織變薄，陰道體液分泌減少，導致性交疼痛或造成尿 失禁、頻尿及陰道萎縮等。雄激素的分泌對於妈質的 吸收會有很大的負面效應，鈣質不易留存體内，骨質 會加速流失，每年約有2〜3%的骨質流失，就會形成骨 質疏鬆症’而且皮下的膝原和黏多醣會減少’容易出 現皮膚皺褶，雌激素也會影繆許多神經傳遞系統，缺 乏時便無法維持神經細胞的多常功能、記憶力受損等 現象。 6 (3);. ':.;. ;;'..: '.. S'λ': ..;-ν'- ·, ·.,: ·: · ^. The invention belongs to the technical field: The invention relates to A composition with phytoestrogen activity, which is made of several Chinese herbal medicine raw materials according to a specific weight ratio. The composition can slow down the menopause syndrome in mammals. Prior technology: After women enter menopause, more than half of menopausal women will suffer a sudden drop in estrogen, lose protection and maintenance of cardiovascular function, and are prone to cardiovascular diseases such as stroke. It also causes the pituitary gonadotropin to rise from time to time, resulting in unstable peripheral vasodilation, and hot flashes, headaches, sore back pain, neck discomfort, insomnia, night sweats, or emotional instability. It will also make the vaginal epidermal tissue thinner and reduce the secretion of vaginal body fluids, causing pain during intercourse or causing urinary incontinence, frequent urination, and vaginal atrophy. The secretion of androgens has a great negative effect on the absorption of maternal mass. Calcium is not easily retained in the body, and bone loss will accelerate. About 2 to 3% of bone loss will occur every year, and osteoporosis will form. Knee origin and mucopolysaccharides will reduce 'prone to skin wrinkles, estrogen will affect many neurotransmission systems, and in the absence of it, it will not be able to maintain the multifunctional function of nerve cells and memory impairment. 6 (3)
、年來，臨床上廣泛建議停經婦女積極採用荷爾蒙 m 希望憑藉外來的補充，使體内荷爾蒙回復 1 ^ ,¾ AA ^ ^ /辰又’ ^夠免除更年期症候群，預防對於 乾么 &系統、骨骼和中樞神經系統產生的功能障礙 和疾病。、、 。上述之更年期症狀經臨床證據顯示許多女性 as 象補充療法之後有顯著改善，一旦停藥則症狀 〜化，、士In recent years, it has been widely suggested clinically that menopausal women actively use hormones. Hope to rely on external supplements to restore hormones in the body to 1 ^, ¾ AA ^ ^ / chen again '^ is enough to avoid menopausal syndrome and prevent what & system, bone And central nervous system dysfunction and disease. ,,. The above-mentioned menopausal symptoms have been clinically proven to show significant improvement in many women as elephant replacement therapy. Once the drug is discontinued, the symptoms will be reduced.
沒現象顯然表示這些不舒服與荷爾蒙的不足有 關係，A 也證明荷爾蒙補充治療對這些症狀的改善確實 有致用。 陰、备 A、及膀胱的支撐組織依賴女性荷爾蒙維持其彈 性及 性，女性荷爾蒙一旦降低則可能引起尿失禁及 陰道齡g L燥易發炎、性交疼痛等問題，荷爾蒙之治療效 t好。而停經後骨質流失加快，容易引起骨折，研 ~發現補充雌激素可以減少50%脊椎骨折及25-30%的鲁 親骨疏鬆。荷爾蒙補充療法也可以對心臟血管疾病的 預防有良好效果，使用雌激素的女性比未使用者減少 約3 5 - 5 0 %罹患心臟血管疾病的風險，因為雌激素可降 低血漿（plasma) 10-14%的低密度脂蛋白（LDL)，並可提 昇高密度脂蛋白（HDL)約7%，所以可預防心臟血管疾病 的發生；雌激素亦可抑制低密度脂蛋白的氧化，進而 改善内皮血管細胞的功能，這些作用皆對心血管疾病 7 200425902There is no evidence that these discomforts are related to the deficiency of hormones, and A also proves that hormonal supplementation treatment does improve the symptoms. The supportive tissues of yin, preparation A, and the bladder rely on female hormones to maintain their elasticity and sexuality. Once the female hormones are lowered, they may cause problems such as urinary incontinence and vaginal age, dryness and inflammation, and pain during sexual intercourse. The bone loss is accelerated after menopause, and it is easy to cause fractures. It has been found that estrogen supplementation can reduce 50% of spinal fractures and 25-30% of osteoporosis. Hormone replacement therapy can also have a good effect on the prevention of cardiovascular disease. Women who use estrogen have about 35-50% less risk of developing cardiovascular disease than non-users, because estrogen can reduce plasma 10- 14% low-density lipoprotein (LDL) and can increase high-density lipoprotein (HDL) by about 7%, so it can prevent the occurrence of cardiovascular disease; estrogen can also inhibit the oxidation of low-density lipoprotein, thereby improving endothelial blood vessels Cell functions, these effects are all on cardiovascular disease 7 200425902
的發生有預防效果。 美國國家衛生研究院近期宣布，中止一項從一九九 三年到二零零五年全美最大規模的荷爾蒙補充療法的 研究，因為發現長期服用雌激素和黃體素，罹乳癌率 增加26%，中風率增加41%，心臟病率增加29%，肺 血栓率增加113%。其中乳癌的風險是在使用三年後才 有顯著的增加，而心臟病則是在一年後就已發現，因 · 此使用荷爾蒙補充療法的風險引起世人的重視。Has a preventive effect. The National Institutes of Health recently announced the suspension of a study on the largest hormone replacement therapy in the United States from 1993 to 2005, because it was found that long-term use of estrogen and progesterone increased the incidence of breast cancer by 26%. The stroke rate increased by 41%, the heart rate increased by 29%, and the pulmonary thrombosis rate increased by 113%. Among them, the risk of breast cancer has increased significantly after three years of use, and heart disease has been detected after one year. Therefore, the risk of using hormone replacement therapy has attracted worldwide attention.
Albertazzi，P·等人於 42: 173-185 (2002)，Albertazzi, P. et al. 42: 173-185 (2002),
The nature and utility of the phytoestrogens: a review of the evidence指出黃豆及一些蔬菜中含有一種植物 性雌激素（Phytoestrogen )，它是一種天然化合物， 其構造與作用類似女性荷爾蒙的化合物 (17点-estradiol)，但其效價僅為此女性荷爾蒙的千 分之一左右。植物雌激素與召雌激素受體之結合能力 _ 遠大於α雌激素受體，因此多作用於中棍神經系統、 血管、骨絡及皮虜，而不會刺激乳房與子宮。植物性 雌激素也因具有雌激素的作用，可以有效改善女性更 年期症狀，它能活化「成骨細胞」’抑制「破骨細胞」， 可以防止骨質的流失；它能降低灰液中低密度脂蛋白 (LDL )的含量，增加高密度脂蛋白（HDL)的含量， 對收縮與舒張血壓也有微降的效果，因而降低了心血 管疾病的發生率；它亦具有抗癌、抗氧化、抗增生、 (5) (5)200425902 ^形成的特質，因此能夠預防子宮内膜的 π〜h厗和 的增生，而具有降低乳癌發生的效果。 發明内容： 本實驗給予未成熟JCR小鼠口服本發明組合物來評估 其植物性雌激素活性。 βThe nature and utility of the phytoestrogens: a review of the evidence indicates that soybeans and some vegetables contain a phytoestrogen (Phytoestrogen), which is a natural compound whose structure and function are similar to those of female hormones (17-estradiol) , But its potency is only about one thousandth of this female hormone. The binding capacity of phytoestrogens and estrogen receptors _ is far greater than that of alpha estrogen receptors, so it acts on the nervous system, blood vessels, bones, and skin cells of the middle stick without irritating the breasts and uterus. Phytoestrogens also have an estrogen effect, which can effectively improve menopausal symptoms in women. It can activate "osteoblasts" and inhibit "osteoclasts". It can prevent bone loss; it can reduce low-density lipids in gray fluid. The content of protein (LDL), increasing the content of high-density lipoprotein (HDL), also has a slight effect on reducing systolic and diastolic blood pressure, thereby reducing the incidence of cardiovascular disease; it also has anti-cancer, anti-oxidation, anti-proliferation (5) (5) 200425902 ^ formation traits, so can prevent π ~ h of the endometrial hyperplasia, and has the effect of reducing the incidence of breast cancer. Summary of the Invention: In this experiment, immature JCR mice were orally administered with the composition of the present invention to evaluate their phytoestrogen activity. β
人本發明係一種具植物性雌激素活性之組合物，其包 含下列重量配比的原料：黑大豆〇· 5 —3〇、黑木耳丨〇、—^ 大棗1 0 ~ 4 0。該組合物中較佳之原料重量配比為累 = ^10-30、黑木耳5 —10及大棗20_40。上述更佳之: σ物，其中黑大豆：黑木耳··大棗之重量比為3:1:4。 性本發明之組合物，可以一般中草藥水萃方式萃取活 、成伤。萃取物可製備成液劑或其他合宜劑型（如呈冷 凍乾燥乾粉形式）便於儲存或調配製劑。 V 〜本發明之組合物可以有效改善女性更年期症狀，詳 s「之，本發明之組合物可預防或改善哺乳動物能活化 「成骨細胞」，抑制「破骨細胞」，可以防止骨質的流 失，降低血液中低密度脂蛋白（LDL)的含量，增加高 密度脂蛋白（HDL )的含量，對收縮與舒張血壓也有微 降的效果，因而降低了心血管疾病的發生率；本發明 之組合物亦具有抗癌、抗氧化、抗增生、抗血管形成 的特質’因此能夠預防子宮内膜的增厚和乳腺的增 生，而具有抗癌的效果。 本發明之組合物適用對象為哺乳動物，較佳適用對 Ί 200425902 ⑹The present invention is a composition having phytoestrogen activity, which comprises the following raw materials in a weight ratio: black soybean 0.5-30, black fungus 丨 〇, ^ Jujube 10 ~ 40. The preferred weight ratio of raw materials in the composition is tired = ^ 10-30, black fungus 5-10 and jujube 20_40. The above is even better: σ, wherein the weight ratio of black soybean: black fungus · jujube is 3: 1: 4. The composition of the present invention can be extracted by conventional Chinese herbal medicine in a water-extracting manner. The extract can be prepared as a liquid or other suitable dosage form (for example, in the form of lyophilized dry powder) for easy storage or formulation. V ~ The composition of the present invention can effectively improve the symptoms of menopause in women. Specifically, the composition of the present invention can prevent or improve mammals' ability to activate "osteoblasts", inhibit "osteoclasts", and prevent bone loss. Reduce the content of low-density lipoprotein (LDL) in the blood, increase the content of high-density lipoprotein (HDL), and have a slight decrease in systolic and diastolic blood pressure, thereby reducing the incidence of cardiovascular disease; the combination of the present invention It also has the characteristics of anti-cancer, anti-oxidation, anti-proliferation, and anti-angiogenesis. Therefore, it can prevent thickening of the endometrium and hyperplasia of the breast, and has an anti-cancer effect. The composition of the present invention is suitable for mammals, and is preferably suitable for Ί 200425902 ⑹
象為人類。 本發明之組合物適用濃度為100-1000 pg/ml，較佳 濃度為100-250 pg/ml，視服用者之體質和進展以及其 他因素（如用於預防或改善）而有所變動。 本發明之組合物亦可依不同投遞路徑與其他職形劑 或載劑一同使用，惟該等賦形劑或載劑以不影響組合 物之活性為前提。 下列實例進一步說明本發明，但非欲限制本發明之 範圍，任何熟悉該項技術者所知之替代和改變，均仍 涵蓋於本發明之範圍中，而不偏離本發明之精神和目 的0 實施方式： 本發明組合物製備實例： 1 ·將配方中所需藥材依序以下列重量配比配比祥 好：黑大豆562.5克、黑木耳1875克及大棗750克。秤 好的藥材放入乾淨的濾布藥袋中並束緊。 2·打開提煉機之鍋蓋，放入藥袋。 3 ·注入2 0公升乾淨純水。 4·蓋上鍋蓋並栓緊所有開關。 5 ·啟動電源，設定好溫度與時間（丨2 〇它，2小時） 6·提煉完成後’將提煉完成之藥汁送至包裝機中進 行包裝或是進行冷凍乾燥製成乾粉。 材料與方法 i〇 200425902Like for humans. The applicable concentration of the composition of the present invention is 100-1000 pg / ml, and the preferred concentration is 100-250 pg / ml, which varies depending on the constitution and progress of the user and other factors (such as for prevention or improvement). The composition of the present invention can also be used with other agents or carriers according to different delivery routes, provided that the excipients or carriers do not affect the activity of the composition. The following examples further illustrate the present invention, but are not intended to limit the scope of the invention. Any substitutions and changes known to those skilled in the art are still included in the scope of the invention without departing from the spirit and purpose of the invention. Ways: Preparation examples of the composition of the present invention: 1. Sequentially mix the required medicinal materials in the formula with the following weight ratios: 562.5 grams of black soybeans, 1875 grams of black fungus and 750 grams of jujube. The weighed medicines are put into a clean filter cloth medicine bag and tightened. 2. Open the lid of the refiner and put it in the medicine bag. 3. Inject 20 litres of clean, pure water. 4. Cover the lid and fasten all switches. 5 · Turn on the power, set the temperature and time (丨 20, 2 hours) 6 · After the refining is completed, send the refined juice to the packaging machine for packaging or freeze-drying to make dry powder. Materials and methods i〇 200425902
1 ·藥品 17-α -ethinyl estradiol(EE)(sigma)配法：秤 取45 mg EE溶於lml 95%酒精中，此為原液。加入適 量水稀釋，使最終濃度為〇. 45//g/ml。 本發明組合物凍乾粉末，每包150ml有1克粉末。成 人每天服用3包，換算成老鼠lx劑量約為每天每隻小 鼠需口服8 mg ; 10x劑量則為每天需80mg。 2 ·實驗動物： 由國家實驗動物繁殖及發明中心購得之雌性ICR小 鼠，體重2 0〜2 5公克，飼養於光照、黑暗各1 2小時，室 溫維持在25±1°C，濕度維持在60±5%，水分與飼料充分 供給之獨立空調的動物房内。本發明中對實驗動物之 處理及一切實驗過程，均依據實驗動物委員會之標準 章程規範進行。 3.動物試驗1 · Pharmaceutical 17-α-ethinyl estradiol (EE) (sigma) Preparation method: Weigh 45 mg of EE and dissolve it in 1 ml of 95% alcohol. This is the original solution. 45 // g / ml。 Dilute with appropriate amount of water to make the final concentration of 0.45 // g / ml. The composition of the present invention is lyophilized powder, and each pack of 150 ml contains 1 g of powder. Adults take 3 sachets per day, which translates to a rat lx dose of approximately 8 mg per mouse per day; a 10x dose requires 80 mg per day. 2 · Experimental animals: Female ICR mice purchased from the National Laboratory Animal Breeding and Invention Center, weighing 20 to 25 grams, reared in light and dark for 12 hours each, room temperature maintained at 25 ± 1 ° C, humidity Keep in an air-conditioned animal room with 60 ± 5% and fully supplied water and feed. The treatment of experimental animals and all experimental processes in the present invention are performed according to the standard regulations of the Experimental Animal Committee. 3. Animal tests
Odum， J.等人於 Reg· Toxicol· Pharmacol. 25: 1 76-1 88( 1 997)The rodent uterotrophic assay : critical protocol features, studies with nonyl phenols， and comparison with a yeast estrogen i ci ty assay揭露最常用來分析這些植物性 化合物是否具有雌激素的活性，大多使用嚅齒類動物 的子宮來分析。一般選擇未成熟或卵巢切除的大鼠或 200425902 ⑻ 小鼠為實驗動物，並以口服或皮下給予方式來測試化 合物疋否具有雌激素活性。 以剛斷奶且未成熟之ICR母鼠（約21-24幻為實驗 每、卫9隻小鼠，進行連續3天的口服餘食試驗。 正控制組為每日 日 母日口服 EE 10 叫/kS，即 0. 45v g/Dil 餵食〇·2 ml。本發明組合物劑量為每天飯食兩次每 次»1 (餃食量為1〇 nl/kg體重⑴），濃度分別為 20 mg/mi及1〇χ : 2〇〇 mg/ml。在餵食後第4天早 上：小鼠犧牲’取其子宮(去除脂肪組織)秤重，並以 子宮濕重量/總體重的百分比來表示雌激素活性。 4.結果 將未成熟之1CR母鼠，進行連續3天的口服徵食 試驗後，結果顯示相較於控制組，每日口服EEiQ^/kg 能明顯增加子宮濕重（圖一，p<〇1)或子宮渴重與體 重的百分比（圖二’！><〇」）。饒食1〇χ本發明組合物雖 能增加子宮濕重（圈一）’但與控制組間無顯著差異； 另以子宮濕重與體重的百分比參數來表示本發明組合 物之植物性雌激素活性時，發隸食…本發明组合物 能明顯增加子宮濕重與體重的百分比（圖二，Ρ<〇 〇, 顯示高濃度本發明組合物具有植物性雕激素活性，然 而艘食ix本發明組合物其子宮濕重或子宮濕重與體重 12 200425902Odum, J. et al. In Reg · Toxicol · Pharmacol. 25: 1 76-1 88 (1 997) The rodent uterotrophic assay: critical protocol features, studies with nonyl phenols, and comparison with a yeast estrogen i ci ty assay Commonly used to analyze whether these plant compounds have estrogen activity, most of them are used in the uterus of dentate animals. Generally, immature or ovariectomized rats or 200425902⑻ mice are selected as experimental animals, and the compound 疋 is tested for its estrogen activity by oral or subcutaneous administration. Freshly weaned and immature ICR female rats (approximately 21-24 phantoms were used as experimental experiments for 9 mice per day), and the oral rest food test was conducted for 3 consecutive days. The positive control group was daily EE 10 oral per day. kS, namely 0.45 v g / Dil, fed 0.2 ml. The dose of the composition of the present invention is two times a day for each meal »1 (the amount of dumplings is 10nl / kg body weight), the concentration is 20 mg / mi and 100x: 200 mg / ml. On the morning of the 4th day after feeding: mice were sacrificed and their uterus (adipose tissue removed) was weighed and the estrogen activity was expressed as a percentage of uterine wet weight / total weight. 4. Results After immature 1CR female rats were subjected to oral feeding test for 3 consecutive days, the results showed that compared with the control group, daily oral EEIQ ^ / kg significantly increased wet weight of the uterus (Figure 1, p < 1) or the percentage of uterine thirst and weight (Figure 2 '! ≫ < 〇 "). Feeding 10x Although the composition of the present invention can increase the uterine wet weight (circle 1)', there is no significant difference with the control group The difference; the percentage of wet weight and weight of the uterus is used to indicate the phytoestrogen activity of the composition of the present invention. The composition can obviously increase the percentage of uterine wet weight and body weight (Fig. 2, P < 〇, shows high concentration of the composition of the present invention has phytohormonal activity, but the composition of the present invention has a uterine wet weight or uterus Wet Weight and Weight 12 200425902
(9) 的百分比與控制組無顯著差異。 5.討論 近十年來發現了許多從植物而來的化合物具有結合 到雌激素受體的能力，也發展出許多體外試驗系統來 偵測或定量天然或合成化合物的雌激素活性（D i e 1，P ·， Schmidt，S. Vollmer，G. In vivo test systems for the quantitative and qualitative analysis of the biological activity of phytoestrogens. J. i 5 777: 191-202，2002·)。但是值得 注意的是，即使結合多種不同的體外測試系統，但還 是不能去預測一個物質在有機體内的作用。在體内， 一個物質會處在許多的代謝途徑及内分泌的交互作用 之中，因此為了解化合物的藥理作用及其潛在危險性 還是必須使用體内測試系統。其中最常用來評估植物 性雌激素在體内是否具有雌激素的活性及其作用機制 的方法，就是以嚅齒類動物的子宮來分析，並以化合 物是否能刺激子宮的生長為決定因子。此種子宮分析 的方法包括了使用未成熟母鼠、垂體切除過或摘除卵 巢的大鼠或小鼠為實驗動物，並以口服或皮下注射方 式來測試化合物是否具有雌激素活性。典型的子宮分 析為以未成熟的母鼠（21-22天）或摘除卵巢的成鼠 13 200425902The percentage of (9) was not significantly different from the control group. 5. Discussion In the past decade, many plant-derived compounds have been found to have the ability to bind to estrogen receptors, and many in vitro test systems have been developed to detect or quantify the estrogen activity of natural or synthetic compounds (Die 1, P., Schmidt, S. Vollmer, G. In vivo test systems for the quantitative and qualitative analysis of the biological activity of phytoestrogens. J. i 5 777: 191-202, 2002.). However, it is worth noting that even when combining different in vitro testing systems, it is not possible to predict the role of a substance in an organism. In the body, a substance is involved in many metabolic pathways and endocrine interactions. Therefore, in order to understand the pharmacological effects of compounds and their potential dangers, it is necessary to use in vivo test systems. The most commonly used method to assess whether phytoestrogens have estrogen activity in the body and its mechanism of action is to analyze the uterus of a dentate animal, and determine whether the compound can stimulate the growth of the uterus as a determining factor. This method of uterine analysis involves the use of immature female mice, pituitary excised or oviposited rats or mice as experimental animals, and the compounds are tested for oral and subcutaneous injection for estrogen activity. Typical uterine analysis is based on immature females (21-22 days) or adult ovaries removed 13 200425902
(ίο) (6 —8週）給予口服或皮下注射測試的化合物3天。第 4天將老鼠犧牲並取子宮秤重。本發明研究結果顯示， 高濃度本發明組合物具有植物性雌激素活性。而動物 種類的選擇並不是實驗的關鍵所在，報告指出，無論 疋大鼠或小鼠’對於各種不同的化合物皆具有相似的 靈敏度。K.S. Kang 等人於 Toxicol· Lett. 118(2000)109指出以未成熟母鼠來評估雌激素活性較 摘除子宮的母鼠更為敏感。此外嚅齒類動物的子宮分 析實驗也可用來測試化合物是否具有拮抗雌激素的功 能’即評估測試化合物是否能減少或破壞子宮對雌激 素的反應。L· J Black 等人於 j. Clin.(ίο) (6-8 weeks) The test compound is administered orally or subcutaneously for 3 days. The rats were sacrificed on day 4 and weighed in the womb. The research results of the present invention show that a high concentration of the composition of the present invention has phytoestrogen activity. The choice of animal species is not the key to the experiment, and the report states that both rats and mice ’have similar sensitivities to various compounds. K.S. Kang et al., Toxicol·Let. 118 (2000) 109 pointed out that immature female mice for assessing estrogen activity are more sensitive than females whose uterus is removed. In addition, dentate animal uterine analysis experiments can also be used to test whether a compound has an estrogen antagonist 'function, that is, to evaluate whether the test compound can reduce or destroy the uterine response to estrogen. L.J Black et al., J. Clin.
Invest.93( 1 994)63 及 G· L· Evans 等人於Invest.93 (1 994) 63 and G.L.Evans et al.
Endocrinology 137(1996)4139指出以子宮分析實驗 來篩選化合物是否具有雌激素活性時仍有些限制，例 如Raloxi f ene藥物雖然不會刺激子宮的生長，但卻在 乳腺或骨頭上具有雌激素活性。因此結合形態學、組 織學、生化或分子層次上的分析可加強子宮分析試驗 的功效。其中最常用來當作組織學上的評估為子宮上 皮性細胞的高度。就藥理學及病理學上而言，子宮上 皮性細胞的高度是評估化合物是否具有植物性雌激素 活性的重要數據。 200425902Endocrinology 137 (1996) 4139 pointed out that there are still some limitations when screening compounds for estrogen activity using uterine analysis experiments. For example, Raloxifene does not stimulate uterine growth, but it has estrogen activity in the breast or bone. Therefore combining morphological, histological, biochemical, or molecular-level analysis can enhance the efficacy of uterine analysis tests. One of the most commonly used for histological evaluation is the height of uterine epithelial cells. In terms of pharmacology and pathology, the height of uterine epithelial cells is important data for assessing whether a compound has phytoestrogen activity. 200425902
00 將未成熟之ICR母鼠，進行連續3天的口服餵食試 驗後，結果顯示餵食高濃度本發明組合物能明顯增加 子宮濕重與體重的百分比，顯示高濃度本發明組合物 具有植物性雌激素活性，因此停經婦女飲用本發明組 合物藉以補充荷爾蒙來減緩更年期症候群。 圖式詳細說明： 以剛斷奶且未成熟之I CR母鼠為實驗動物，進行連 績3天的口服餵食試驗。正控制組為每日口服EE j 〇 pg/kg。本發明組合物劑量為每天餵食4:8關及1〇χ: 8〇mg。在饒食後第4天早上將小鼠犧牲，並以子宮濕 重（Δ)或子宮濕重/總體重的百分比（b)來表示雌激 素活性。利用 KruskabWaUis H test，並以 Dunnett t Test作為事後檢定法；*表與控制組比較具顯著差異 (P<0. 1 ) 〇 圖式簡單說明： 圖顯不飯食本發明組合物對未成熟ICR母鼠之子宮 濕、重之影響。 圖一顯不餵食本發明組合物對未成熟ICR母鼠之子 宮濕重/總體重的百分比之影響。 唯以上所诚^ ^ ^ i有，僅係本發明部份較佳實例說明，故 凡應用本發日月說明及申請專利範圍所為之等效方法之 \5 200425902 (12) 變化，理應包含在本發明之專利範圍内。00 After immature ICR female rats were subjected to oral feeding tests for 3 consecutive days, the results showed that feeding the high concentration of the composition of the present invention can significantly increase the percentage of wet weight and weight of the uterus, showing that the high concentration of the composition of the present invention has a plant female Hormonal activity, so menopausal women drink the composition of the present invention to supplement hormones to reduce menopausal syndrome. Detailed description of the figure: A newly weaned and immature I CR female mouse was used as an experimental animal to perform an oral feeding test for 3 consecutive days. In the positive control group, daily oral EE j pg / kg. The dosage of the composition of the present invention is 4: 8 guan and 10x: 80 mg fed daily. Mice were sacrificed on the morning of the 4th day after fasting, and estrogen activity was expressed in terms of uterine wet weight (Δ) or uterine wet weight / total weight (b). KruskabWaUis H test is used, and Dunnett Test is used as the post-hoc test method. * The table is significantly different from the control group (P < 0.1). Schematic description: The figure shows no meal. The effect of rat uterus wet and heavy. Figure 1 shows the effect of non-feeding of the composition of the present invention on the percentage of wet / total weight of the offspring of immature ICR females. Only the above ^ ^ ^ i is provided, it is only a description of some preferred examples of the present invention. Therefore, any application of the equivalent method of the date and month description and the scope of the patent application for the application of \ 5 200425902 (12) changes should be included in Within the patent scope of the present invention.
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