TWI789331B - Cancer vaccine composition and kit - Google Patents

Cancer vaccine composition and kit Download PDF

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TWI789331B
TWI789331B TW105107576A TW105107576A TWI789331B TW I789331 B TWI789331 B TW I789331B TW 105107576 A TW105107576 A TW 105107576A TW 105107576 A TW105107576 A TW 105107576A TW I789331 B TWI789331 B TW I789331B
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曹始永
金完起
朴贊雄
徐大方
申松錫
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Abstract

The present disclosure relates to a cancer vaccine composition and a kit which contain a natural extract as an active ingredient. A composition according to an aspect of the present disclosure, which contains a ginseng berry extract, activates the immune function of the human body and is useful in treating cancer. A composition according to another aspect of the present disclosure, which further contains ovalbumin in addition to the ginseng berry extract, exhibits remarkable effect in preventing, improving and treating cancer due to a maximized synergic effect of the two ingredients. Because the immune mechanism of the body is used, cancer can be treated without the side effects of the existing anticancer drug therapy and radiation therapy.

Description

癌症疫苗組合物與套組 Cancer Vaccine Compositions and Kits

本揭示內容係關於含有天然提取物作為活性成分的癌症疫苗組合物與套組。 The present disclosure relates to cancer vaccine compositions and kits containing natural extracts as active ingredients.

近來,用詞免疫性頻繁地出現在各種疾病之治療中。免疫系統遍佈於體內。免疫系統防禦來自外界的微生物或病原體之侵入,且一旦在該等病原體進入體內後將之清除。 Recently, the term immunity has frequently appeared in the treatment of various diseases. The immune system pervades the body. The immune system defends against the invasion of microorganisms or pathogens from the outside, and eliminates these pathogens once they enter the body.

近來,亦在癌症之治療中提及『免疫性』。最為期望之抗癌療法為在不破壞正常細胞的情況下選擇地殺死癌細胞。然而,先前已知的抗癌藥物療法或放射療法無法在某種程度上避免對正常組織的破壞。正在對使用人體之免疫機制清除癌細胞之治療方法進行研究,該免疫機制為在最小副作用的情況下抵抗疾病的防禦系統之一。 Recently, "immunity" is also mentioned in the treatment of cancer. The most desired anticancer therapy is to selectively kill cancer cells without destroying normal cells. However, previously known anticancer drug therapy or radiation therapy cannot avoid damage to normal tissue to some extent. Research is being conducted on treatments that use the body's immune mechanism, one of the defense systems to fight disease with minimal side effects, to eliminate cancer cells.

(非專利文獻1)Topalian SL等人,J Clin Oncol 1988; 6: 839-53。 (Non-Patent Document 1) Topalian SL et al., J Clin Oncol 1988; 6: 839-53.

在一態樣中,本揭示內容係關於提供在治療癌症中具有協同效應之組合物。 In one aspect, the present disclosure relates to providing compositions that have a synergistic effect in the treatment of cancer.

在一態樣中,本揭示內容提供含有人參漿果提取物作為活性成分的癌症疫苗組合物。 In one aspect, the present disclosure provides a cancer vaccine composition comprising ginseng berry extract as an active ingredient.

在另一態樣中,本揭示內容提供用於促進骨髓細胞之增殖的組合物,該組合物含有人參漿果提取物作為活性成分。 In another aspect, the present disclosure provides a composition for promoting proliferation of bone marrow cells, the composition comprising ginseng berry extract as an active ingredient.

在另一態樣中,本揭示內容提供用於活化樹狀細胞的組合物,該組合物含有人參漿果提取物作為活性成分。 In another aspect, the present disclosure provides a composition for activating dendritic cells comprising ginseng berry extract as an active ingredient.

在另一態樣中,本揭示內容提供用於促進T細胞之活化的組合物,該組合物含有人參漿果提取物作為活性成分。 In another aspect, the present disclosure provides a composition for promoting activation of T cells, the composition comprising ginseng berry extract as an active ingredient.

在另一態樣中,本揭示內容提供含有以下各項之套組:含有卵白蛋白之組合物;含有人參漿果提取物之組合物;和說明書,其中該說明書描述含有卵清蛋白之組合物及含有人參漿果提取物之組合物的同時投藥方法。 In another aspect, the disclosure provides a kit comprising: a composition comprising ovalbumin; a composition comprising ginseng berry extract; and instructions, wherein the instructions describe the composition comprising ovalbumin and Simultaneous administration method of composition containing ginseng berry extract.

根據本揭示內容之一態樣的含有人參漿果提取物之組合物適用於治療癌症,因為該組合物激活人體之免疫功能。根據本揭示內容之另一態樣的除人參漿果提取物之外進一步含有卵白蛋白之組合物在預防、改善 及治療癌症方面展現顯著效應,此係歸因於兩種成分之最大化協同效應。因為使用身體之免疫機制,所以可在沒有現存抗癌藥物療法及放射療法之副作用的情況下治療癌症。 A composition containing ginseng berry extract according to an aspect of the present disclosure is suitable for treating cancer because the composition activates the immune function of the human body. According to another aspect of the disclosure, the composition further containing ovalbumin in addition to the ginseng berry extract is effective in preventing, improving and cancer treatment, which is attributed to the maximized synergistic effect of the two components. Because the body's immune mechanisms are used, cancer can be treated without the side effects of existing anticancer drug therapies and radiation therapy.

第1a及1b圖展示在利用100g/mL人參根提取物(ginseng root;GR)或人參漿果提取物(ginseng berry;GB)治療之後24小時的骨髓細胞增殖。 Figures 1a and 1b show bone marrow cell proliferation 24 hours after treatment with 100 g/mL ginseng root extract (ginseng root; GR) or ginseng berry extract (ginseng berry; GB).

第2圖展示在向6週大小鼠靜脈注射10mg/kg或50mg/kg人參漿果提取物之後24小時藉由FACS測定的CD11c+樹狀細胞之數量。 Figure 2 shows the number of CD11c + dendritic cells determined by FACS 24 hours after intravenous injection of 10 mg/kg or 50 mg/kg ginseng berry extract to 6-week-old mice.

第3圖展示在以3天間隔向6週大小鼠靜脈注射50mg/kg人參漿果提取物2次之後測定的產生IFN-γ及TNF-α之輔助T細胞及殺手T細胞之數量。 Figure 3 shows the numbers of IFN-γ and TNF-α producing helper T cells and killer T cells measured after intravenous injection of 50 mg/kg ginseng berry extract to 6-week-old mice twice at 3-day intervals.

第4圖展示在僅投與卵白蛋白(ovalbumin;OVA)或投與卵白蛋白及人參漿果提取物(ovalbumin and ginseng berry extract;OVA+GB)之後量測的樹狀細胞之抗原呈現能力的提高。 Figure 4 shows the increase in antigen presentation capacity of dendritic cells measured after administration of ovalbumin (OVA) alone or ovalbumin and ginseng berry extract (OVA+GB).

第5圖展示在僅投與卵白蛋白(ovalbumin;OVA)或投與卵白蛋白及人參漿果提取物(ovalbumin and ginseng berry extract;OVA+GB)之後量測的抗原特異T細胞之增殖。 Figure 5 shows the proliferation of antigen-specific T cells measured after administration of ovalbumin (OVA) alone or ovalbumin and ginseng berry extract (OVA+GB).

第6圖展示在向植入腫瘤的小鼠僅投與卵白蛋白(ovalbumin;OVA)或投與卵白蛋白及人參漿果提取物(ovalbumin and ginseng berry extract;OVA+GB)之後量測的腫瘤體積。 FIG. 6 shows tumor volumes measured after administration of ovalbumin (OVA) alone or ovalbumin and ginseng berry extract (OVA+GB) to tumor-implanted mice.

下文中,詳細描述本揭示內容。 Hereinafter, the present disclosure is described in detail.

在一態樣中,本揭示內容提供含有人參漿果提取物作為活性成分的癌症疫苗組合物。 In one aspect, the present disclosure provides a cancer vaccine composition comprising ginseng berry extract as an active ingredient.

在一態樣中,本揭示內容提供用於改良身體抵抗癌症之免疫功能的方法,該方法包括以下步驟:向有需要之受試者投與人參漿果提取物。 In one aspect, the present disclosure provides a method for improving the body's immune function against cancer, the method comprising the step of: administering ginseng berry extract to a subject in need thereof.

在一態樣中,本揭示內容提供人參漿果提取物在改良身體抵抗癌症之免疫功能中之用途。 In one aspect, the present disclosure provides the use of ginseng berry extract for improving the immune function of the body against cancer.

在一態樣中,本揭示內容提供人參漿果提取物在製備用於改良身體抵抗癌症之免疫功能的組合物中之用途。 In one aspect, the present disclosure provides the use of ginseng berry extract in the preparation of a composition for improving the immune function of the body against cancer.

在本揭示內容中,『癌症疫苗』可指代用於活性免疫療法的物質,其中身體之免疫功能藉由向癌症患者投與癌細胞之癌症特異抗原而激活,進而攻擊癌細胞且消除癌症。 In this disclosure, a "cancer vaccine" may refer to a substance used in active immunotherapy, in which the body's immune function is activated by administering cancer-specific antigens of cancer cells to a cancer patient, thereby attacking cancer cells and eliminating the cancer.

在本揭示內容中,『癌症』可指代未分化細胞之腫塊或腫瘤在組織中無限生長的疾病。由於異常細胞不受調節地生長,因而該等異常細胞可侵襲組織及器官附近,進而形成腫塊及毀壞或改變現存結構。最終, 該等細胞可導致死亡,因為其毀壞附近正常組織或器官且擴散至其他器官。癌症之實例包括但不限於以下癌症:腦部腫瘤及脊髓腫瘤、頭頸癌、肺癌、乳癌、胸腺瘤、間皮瘤、食管癌、胃癌、結腸癌、肝癌、胰腺癌、膽管癌、腎癌、膀胱癌、前列腺癌、睾丸癌、生殖細胞腫瘤、卵巢癌、子宮頸癌、子宮內膜癌、淋巴瘤、急性白血病、慢性白血病、多發性骨髓瘤、肉瘤、惡性黑素瘤及皮膚癌。 In this disclosure, "cancer" may refer to a disease in which a mass of undifferentiated cells or a tumor grows indefinitely in a tissue. Due to their unregulated growth, abnormal cells can invade tissues and nearby organs, forming masses and destroying or altering existing structures. finally, These cells can cause death as they destroy nearby normal tissues or organs and spread to other organs. Examples of cancers include, but are not limited to, the following cancers: brain and spinal cord tumors, head and neck cancer, lung cancer, breast cancer, thymoma, mesothelioma, esophagus cancer, stomach cancer, colon cancer, liver cancer, pancreatic cancer, bile duct cancer, kidney cancer, Bladder cancer, prostate cancer, testicular cancer, germ cell tumors, ovarian cancer, cervical cancer, endometrial cancer, lymphoma, acute leukemia, chronic leukemia, multiple myeloma, sarcoma, malignant melanoma and skin cancer.

在一態樣中,本揭示內容提供用於促進骨髓細胞之增殖的組合物,該組合物含有人參漿果提取物作為活性成分。 In one aspect, the present disclosure provides a composition for promoting proliferation of bone marrow cells, the composition comprising ginseng berry extract as an active ingredient.

在一態樣中,本揭示內容提供用於促進骨髓細胞之增殖的方法,該方法包括以下步驟:向有需要之受試者投與人參漿果提取物。 In one aspect, the present disclosure provides a method for promoting proliferation of bone marrow cells, the method comprising the step of: administering ginseng berry extract to a subject in need thereof.

在一態樣中,本揭示內容提供人參漿果提取物在促進骨髓細胞之增殖中之用途。 In one aspect, the present disclosure provides the use of ginseng berry extract for promoting proliferation of bone marrow cells.

在一態樣中,本揭示內容提供人參漿果提取物在製備用於促進骨髓細胞之增殖的組合物中之用途。 In one aspect, the present disclosure provides the use of ginseng berry extract in the preparation of a composition for promoting proliferation of bone marrow cells.

在另一態樣中,本揭示內容提供用於活化樹狀細胞的組合物,該組合物含有人參漿果提取物作為活性成分。 In another aspect, the present disclosure provides a composition for activating dendritic cells comprising ginseng berry extract as an active ingredient.

在一態樣中,本揭示內容提供用於活化樹狀細胞的方法,該方法包括以下步驟:向有需要之受試者投與人參漿果提取物。 In one aspect, the present disclosure provides a method for activating dendritic cells, the method comprising the step of: administering ginseng berry extract to a subject in need thereof.

在一態樣中,本揭示內容提供人參漿果提取物在活化樹狀細胞中之用途。 In one aspect, the present disclosure provides the use of ginseng berry extract in activating dendritic cells.

在一態樣中,本揭示內容提供人參漿果提取物在製備用於活化樹狀細胞的組合物中之用途。 In one aspect, the present disclosure provides the use of ginseng berry extract in the preparation of a composition for activating dendritic cells.

在另一態樣中,本揭示內容提供用於促進T細胞之活化的組合物,該組合物含有人參漿果提取物作為活性成分。 In another aspect, the present disclosure provides a composition for promoting activation of T cells, the composition comprising ginseng berry extract as an active ingredient.

在一態樣中,本揭示內容提供用於促進T細胞之活化的方法,該方法包括以下步驟:向有需要之受試者投與人參漿果提取物。 In one aspect, the present disclosure provides a method for promoting activation of T cells, the method comprising the step of: administering ginseng berry extract to a subject in need thereof.

在一態樣中,本揭示內容提供人參漿果提取物在促進T細胞之活化中之用途。 In one aspect, the present disclosure provides the use of ginseng berry extract in promoting the activation of T cells.

在一態樣中,本揭示內容提供人參漿果提取物在製備用於促進T細胞之活化的組合物中之用途。 In one aspect, the present disclosure provides the use of ginseng berry extract in the preparation of a composition for promoting the activation of T cells.

T細胞可包括殺手T細胞、輔助T細胞、調節T細胞及記憶T細胞。 T cells may include killer T cells, helper T cells, regulatory T cells and memory T cells.

在本揭示內容中,『人參』可為高麗參或人參(Panax ginseng)。 In the present disclosure, "ginseng" can be Korean ginseng or ginseng ( Panax ginseng ).

在本揭示內容中,『提取物』包括自天然產物提取的任何物質,而不管提取方法、提取溶劑、所提取成分或提取物之類型。該術語係以廣意概念使用,包括藉由以其他方式加工或處理所獲得提取物而獲得的物質。具體而言,加工或處理可為提取物之發酵或酶促處理。因此,在本揭示內容中,提取物包括發酵產物、濃 縮產物及乾燥產物。具體而言,本揭示內容中之提取物可為發酵產物。 In this disclosure, "extract" includes any substance extracted from a natural product, regardless of extraction method, extraction solvent, extracted component or type of extract. The term is used in a broad sense and includes substances obtained by otherwise processing or treating the obtained extract. In particular, processing or treatment may be fermentation or enzymatic treatment of the extract. Thus, in the present disclosure, extracts include fermentation products, concentrated shrinkage and drying products. In particular, extracts in the present disclosure may be fermentation products.

在本揭示內容中,『人參漿果(ginseng berry)』可意指人參之果實。具體而言,其可意指3至5年大的人參、更具體而言4年大的人參之果實,其在七月中成熟約一週。用於本揭示內容之人參漿果不限於其如何獲得。可栽培人參或在商業上購買。 In the present disclosure, "ginseng berry" may mean the fruit of ginseng. Specifically, it may mean the fruits of 3 to 5 year old ginseng, more specifically 4 year old ginseng, which ripen for about a week in July. Ginseng berries for use in the present disclosure are not limited by how they are obtained. Ginseng can be cultivated or purchased commercially.

本揭示內容之人參漿果含有比常用於此項技術中之人參根更多的礦物成分,包括維生素及人參皂苷(ginsenosides)。特定而言,人參漿果與人參根在人參皂苷之組合物上完全不同。更具體而言,人參漿果可展現比人參根顯著更好的效應,因為其比包括人參皂苷Rb1、Rb2、Rc、Rd等等的基於原人參二醇(protopanaxadiol;PD)的人參皂苷含有更多的包括人參皂苷Re、Rg1、Rg2等等的基於原人參三醇(protopanaxatriol;PT)的人參皂苷。 Ginseng berries of the present disclosure contain more mineral components, including vitamins and ginsenosides, than ginseng roots commonly used in the art. Specifically, ginseng berries and ginseng roots are completely different in composition of ginsenosides. More specifically, ginseng berries can exhibit significantly better effects than ginseng roots because they contain more Protopanaxatriol (PT)-based ginsenosides including ginsenosides Re, Rg1, Rg2 and the like.

在本揭示內容中,『人參漿果提取物』包括自人參漿果提取的任何物質,而不管提取方法、提取溶劑、所提取成分或提取物之類型。其包括可藉由利用熱、酸、鹼、酶等處理所提取物質,且該術語係以廣義概念使用,包括可藉由以其他方式加工或處理所獲得提取物而獲得的物質。具體而言,加工或處理可為人參漿果提取物之發酵或酶促處理。因此,在本揭示內容中,人參漿果提取物可為發酵產物。此外,在本揭示內容中,人 參漿果提取物可具體而言為活人參漿果之提取物或乾燥人參漿果之提取物。在本揭示內容中,活人參漿果、乾燥人參漿果或人參漿果之其他加工產物(例如,發酵產物、磨碎乾燥產物等等)可在組成上類似或相同。因此,在組成上類似或相同的活人參漿果、乾燥人參漿果或人參漿果之其他加工產物可展現本揭示內容所欲的相同效應。 In this disclosure, "ginseng berry extract" includes any substance extracted from ginseng berries, regardless of extraction method, extraction solvent, extracted component or type of extract. It includes substances that can be extracted by treating them with heat, acid, alkali, enzymes, etc., and this term is used in a broad sense including substances that can be obtained by processing or treating the obtained extracts in other ways. Specifically, the processing or treatment may be fermentation or enzymatic treatment of ginseng berry extract. Therefore, in the present disclosure, the ginseng berry extract may be a fermentation product. Furthermore, in this disclosure, people The ginseng berry extract may specifically be an extract of live ginseng berries or an extract of dried ginseng berries. In the present disclosure, live ginseng berries, dried ginseng berries, or other processed products of ginseng berries (eg, fermented products, ground dried products, etc.) may be similar or identical in composition. Thus, compositionally similar or identical live ginseng berries, dried ginseng berries, or other processed products of ginseng berries may exhibit the same effects intended by the present disclosure.

在本揭示內容中,人參漿果提取物可藉由加熱提取、冷提取、回流冷凝提取、超音波提取等等獲得。然而,可使用而不限於對熟習此項技術者明顯的提取方法。用於製備本揭示內容之人參漿果提取物的人參漿果可為乾燥人參漿果、活人參漿果、人參漿果粉末等。可使用而不限於自活人參漿果製備的任何物質。本揭示內容之人參漿果提取物可為人參漿果之C1-C6醇提取物,具體而言人參漿果之乙醇提取物。更具體而言,本揭示內容之人參漿果提取物可為藉由添加C1-C6醇、具體而言乙醇來提取人參漿果而獲得的提取物。本揭示內容之人參漿果提取物亦包括藉由在減壓下濃縮利用乙醇進行提取所獲得的提取物而獲得的人參漿果提取物。具體而言,在減壓下濃縮可在35-50℃下執行,但並不限於此。當在上述溫度範圍中執行在減壓下濃縮時,達成本揭示內容之人參漿果提取物中各種成分之優異協同效應。在此態樣中,在減壓下濃縮可具體而言在36℃或高於36℃、37℃或高於37℃、38℃或高於38℃、39℃或高 於39℃、40℃或高於40℃、41℃或高於41℃或42℃或高於42℃下及/或在49℃或低於49℃、48℃或低於48℃、47℃或低於47℃、46℃或低於46℃、45℃或低於45℃、44℃或低於44℃或43℃或低於43℃下執行。此外,在減壓下濃縮可具體而言在600mmHg或更高、620mmHg或更高、640mmHg或更高、650mmHg或更高、660mmHg或更高、680mmHg或更高、700mmHg或更高、720mmHg或更高或740mmHg或更高下,及/或在760mmHg或更低、740mmHg或更低、720mmHg或更低、700mmHg或更低、680mmHg或更低、660mmHg或更低、650mmHg或更低、640mmHg或更低、620mmHg或更低或600mmHg或更低下執行。 In the present disclosure, the ginseng berry extract can be obtained by heating extraction, cold extraction, reflux condensation extraction, ultrasonic extraction and the like. However, extraction methods apparent to those skilled in the art may be used without limitation. The ginseng berries used to prepare the ginseng berry extract of the present disclosure may be dried ginseng berries, live ginseng berries, ginseng berry powder, and the like. Any substance prepared from live ginseng berries may be used without limitation. The ginseng berry extract of the present disclosure can be a C 1 -C 6 alcoholic extract of ginseng berry, specifically an ethanolic extract of ginseng berry. More specifically, the ginseng berry extract of the present disclosure may be an extract obtained by adding C 1 -C 6 alcohols, specifically ethanol, to extract ginseng berries. The ginseng berry extract of the present disclosure also includes a ginseng berry extract obtained by concentrating an extract obtained by extraction with ethanol under reduced pressure. Specifically, concentration under reduced pressure may be performed at 35-50° C., but is not limited thereto. The excellent synergistic effect of the various components in the ginseng berry extract of the present disclosure is achieved when concentration under reduced pressure is performed in the above temperature range. In this aspect, concentration under reduced pressure may specifically be at or above 36°C, 37°C or above 37°C, 38°C or above 38°C, 39°C or above 39°C, 40°C or above 40°C, 41°C or above 41°C, or 42°C or above 42°C and/or at or below 49°C, 48°C or below 48°C, 47°C or below 47°C, 46°C or lower, 45°C or lower, 44°C or lower, or 43°C or lower. Further, concentration under reduced pressure may be specifically at 600 mmHg or higher, 620 mmHg or higher, 640 mmHg or higher, 650 mmHg or higher, 660 mmHg or higher, 680 mmHg or higher, 700 mmHg or higher, 720 mmHg or higher High or at 740mmHg or more, and/or at 760mmHg or less, 740mmHg or less, 720mmHg or less, 700mmHg or less, 680mmHg or less, 660mmHg or less, 650mmHg or less, 640mmHg or more Low, 620mmHg or lower, or 600mmHg or lower.

在本揭示內容之一態樣中,人參漿果提取物可藉由以下方式獲得:1)在移除種子之後藉由經由日光乾燥或熱風乾燥活人參(ginseng)(人參(Panax ginseng C.A.Meyer))之果實的漿及外皮來製備乾燥人參漿果;及2)在室溫下藉由添加水或有機溶劑(尤其是乙醇)且隨後在40-45℃及600-700mmHg下在減壓下濃縮來提取乾燥人參漿果。 In one aspect of the present disclosure, the ginseng berry extract can be obtained by: 1) by drying live ginseng (ginseng) ( Panax ginseng CA Meyer) by sun drying or hot air drying after removing the seeds pulp and skin of the fruit to prepare dried ginseng berries; and 2) extraction and drying at room temperature by adding water or an organic solvent (especially ethanol) and then concentrating under reduced pressure at 40-45° C. and 600-700 mmHg Ginseng berries.

本揭示內容之人參漿果提取物可含有人參皂苷Rb1、人參皂苷Rb2、人參皂苷Rb3、人參皂苷Rc、人參皂苷Rd、人參皂苷Re、人參皂苷Rg1或人參皂苷Rg2。然而,因為本揭示內容之人參漿果提取物含有包 括除人參皂苷之外的維生素、礦物質及花青素之各種物質,根據本揭示內容之一態樣的組合物之效應來源於各種物質之協同效應,而非來源於單一人參皂苷或人參皂苷之組合(例如,皂素)。 The ginsenoside berry extract of the present disclosure may contain ginsenoside Rb1, ginsenoside Rb2, ginsenoside Rb3, ginsenoside Rc, ginsenoside Rd, ginsenoside Re, ginsenoside Rg1 or ginsenoside Rg2. However, since the ginseng berry extract of the present disclosure contains Various substances including vitamins, minerals, and anthocyanins other than ginsenosides, the effect of the composition according to an aspect of the present disclosure is derived from the synergistic effect of various substances, rather than from a single ginsenoside or ginsenoside combination (for example, saponin).

在一態樣中,組合物可進一步含有白蛋白作為活性成分。白蛋白之濃度可為0.001-0.1μg/mL。具體而言,濃度可為0.0009μg/mL或更高、0.001μg/mL或更高、0.005μg/mL或更高、0.007μg/mL或更高、0.009μg/mL或更高、0.01μg/mL或更高、0.013μg/mL或更高、0.015μg/mL或更高、0.02μg/mL或更高、0.03μg/mL或更高、0.04μg/mL或更高、0.045μg/mL或更高、0.05μg/mL或更高、0.051μg/mL或更高、0.055μg/mL或更高、0.06μg/mL或更高、0.065μg/mL或更高、0.07μg/mL或更高、0.08μg/mL或更高、0.09μg/mL或更高、0.095μg/mL或更高、0.099μg/mL或更高、0.1μg/mL或更高或0.11μg/mL或更高,及0.12μg/mL或更低、0.11μg/mL或更低、0.1μg/mL或更低、0.09μg/mL或更低、0.08μg/mL或更低、0.07μg/mL或更低、0.06μg/mL或更低、0.05μg/mL或更低、0.04μg/mL或更低、0.03μg/mL或更低、0.02μg/mL或更低、0.01μg/mL或更低、0.009μg/mL或更低、0.005μg/mL或更低、0.004μg/mL或更低、 0.003μg/mL或更低、0.002μg/mL或更低、0.001μg/mL或更低或0.0009μg/mL或更低。 In one aspect, the composition may further contain albumin as an active ingredient. The concentration of albumin may be 0.001-0.1 μg/mL. Specifically, the concentration may be 0.0009 μg/mL or higher, 0.001 μg/mL or higher, 0.005 μg/mL or higher, 0.007 μg/mL or higher, 0.009 μg/mL or higher, 0.01 μg/mL or higher, mL or higher, 0.013 μg/mL or higher, 0.015 μg/mL or higher, 0.02 μg/mL or higher, 0.03 μg/mL or higher, 0.04 μg/mL or higher, 0.045 μg/mL or Higher, 0.05 μg/mL or higher, 0.051 μg/mL or higher, 0.055 μg/mL or higher, 0.06 μg/mL or higher, 0.065 μg/mL or higher, 0.07 μg/mL or higher , 0.08 μg/mL or greater, 0.09 μg/mL or greater, 0.095 μg/mL or greater, 0.099 μg/mL or greater, 0.1 μg/mL or greater, or 0.11 μg/mL or greater, and 0.12 μg/mL or less, 0.11 μg/mL or less, 0.1 μg/mL or less, 0.09 μg/mL or less, 0.08 μg/mL or less, 0.07 μg/mL or less, 0.06 μg /mL or less, 0.05 μg/mL or less, 0.04 μg/mL or less, 0.03 μg/mL or less, 0.02 μg/mL or less, 0.01 μg/mL or less, 0.009 μg/mL or lower, 0.005 μg/mL or lower, 0.004 μg/mL or lower, 0.003 μg/mL or less, 0.002 μg/mL or less, 0.001 μg/mL or less, or 0.0009 μg/mL or less.

白蛋白可為卵白蛋白。在本揭示內容中,卵白蛋白指代存在於蛋白中之蛋白質,除胺基酸等之外其亦含有糖、磷酸鹽等。因為根據本揭示內容之一態樣的組合物之效應係來源於人參漿果提取物中所含有的各種物質及白蛋白(例如,卵白蛋白)之組合的協同效應,即相較於當僅僅使用人參漿果提取物時的情況在改善、預防及治療癌症中可達成的更好效應。 Albumin may be ovalbumin. In this disclosure, ovalbumin refers to protein present in albumen, which also contains sugars, phosphates, etc. in addition to amino acids, etc. Because the effect of the composition according to an aspect of the present disclosure is derived from the synergistic effect of the combination of various substances contained in the ginseng berry extract and albumin (for example, ovalbumin), that is, compared to when only ginseng When the berry extract is used, it can achieve better effects in the improvement, prevention and treatment of cancer.

根據本揭示內容之一態樣的組合物可含有以組合物之總重量計0.001-80.0wt%之人參漿果提取物。具體而言,根據本揭示內容之一態樣的組合物可含有以組合物之總重量計0.0005wt%或更大、0.0007wt%或更大、0.0009wt%或更大、0.001wt%或更大、0.003wt%或更大、0.005wt%或更大、0.007wt%或更大、0.009wt%或更大、0.01wt%或更大、0.05wt%或更大、0.1wt%或更大、1wt%或更大、5wt%或更大、10wt%或更大、15wt%或更大、20wt%或更大、30wt%或更大、40wt%或更大、45wt%或更大、50wt%或更大、55wt%或更大、60wt%或更大、65wt%或更大、70wt%或更大、75wt%或更大、80wt%或更大、85wt%或更大或90wt%或更大,或99wt%或更小、90wt%或更小、80wt%或更小、75wt%或更小、65wt%或更小、60wt%或更小、 55wt%或更小、50wt%或更小、45wt%或更小、40wt%或更小、30wt%或更小、20wt%或更小、10wt%或更小、5wt%或更小、1wt%或更小、0.1wt%或更小、0.05wt%或更小、0.03wt%或更小、0.01wt%或更小、0.008wt%或更小、0.006wt%或更小、0.004wt%或更小、0.002wt%或更小、0.001wt%或更小或0.0005wt%或更小之人參漿果提取物。 The composition according to one aspect of the present disclosure may contain 0.001-80.0 wt% of ginseng berry extract based on the total weight of the composition. Specifically, the composition according to one aspect of the present disclosure may contain 0.0005 wt % or more, 0.0007 wt % or more, 0.0009 wt % or more, 0.001 wt % or more, based on the total weight of the composition Large, 0.003wt% or more, 0.005wt% or more, 0.007wt% or more, 0.009wt% or more, 0.01wt% or more, 0.05wt% or more, 0.1wt% or more , 1wt% or more, 5wt% or more, 10wt% or more, 15wt% or more, 20wt% or more, 30wt% or more, 40wt% or more, 45wt% or more, 50wt % or more, 55wt% or more, 60wt% or more, 65wt% or more, 70wt% or more, 75wt% or more, 80wt% or more, 85wt% or more or 90wt% or Greater, or 99wt% or less, 90wt% or less, 80wt% or less, 75wt% or less, 65wt% or less, 60wt% or less, 55wt% or less, 50wt% or less, 45wt% or less, 40wt% or less, 30wt% or less, 20wt% or less, 10wt% or less, 5wt% or less, 1wt% or less, 0.1wt% or less, 0.05wt% or less, 0.03wt% or less, 0.01wt% or less, 0.008wt% or less, 0.006wt% or less, 0.004wt% or Less, 0.002 wt% or less, 0.001 wt% or less, or 0.0005 wt% or less of ginseng berry extract.

在此態樣中,人參漿果提取物之濃度可為1-100μg/mL。具體而言,濃度可為0.5μg/mL或更高、0.9μg/mL或更高、1.0μg/mL或更高、5μg/mL或更高、10μg/mL或更高、15μg/mL或更高、20μg/mL或更高、30μg/mL或更高、40μg/mL或更高、45μg/mL或更高、48μg/mL或更高、49μg/mL或更高、50μg/mL或更高、51μg/mL或更高、52μg/mL或更高、55μg/mL或更高、60μg/mL或更高、70μg/mL或更高、80μg/mL或更高、90μg/mL或更高、100μg/mL或更高、101μg/mL或更高或105μg/mL或更高,且可為106μg/mL或更低、101μg/mL或更低、96μg/mL或更低、91μg/mL或更低、81μg/mL或更低、71μg/mL或更低、61μg/mL或更低、56μg/mL或更低、53μg/mL或更低、52μg/mL或更低、51μg/mL或更低、50μg/mL或更低、49μg/mL或更低、48μg/mL或更低、45μg/mL或更低、40μg/mL或更低、30μg/mL或更低、20μg/mL或更低、10 μg/mL或更低、9μg/mL或更低、7μg/mL或更低、5μg/mL或更低、3μg/mL或更低、1μg/mL或更低、0.9μg/mL或更低、0.7μg/mL或更低或0.5μg/mL或更低。 In this aspect, the concentration of ginseng berry extract may be 1-100 μg/mL. Specifically, the concentration may be 0.5 μg/mL or higher, 0.9 μg/mL or higher, 1.0 μg/mL or higher, 5 μg/mL or higher, 10 μg/mL or higher, 15 μg/mL or higher High, 20 μg/mL or higher, 30 μg/mL or higher, 40 μg/mL or higher, 45 μg/mL or higher, 48 μg/mL or higher, 49 μg/mL or higher, 50 μg/mL or higher , 51 μg/mL or higher, 52 μg/mL or higher, 55 μg/mL or higher, 60 μg/mL or higher, 70 μg/mL or higher, 80 μg/mL or higher, 90 μg/mL or higher, 100 μg/mL or more, 101 μg/mL or more, or 105 μg/mL or more, and may be 106 μg/mL or less, 101 μg/mL or less, 96 μg/mL or less, 91 μg/mL or more Low, 81 μg/mL or less, 71 μg/mL or less, 61 μg/mL or less, 56 μg/mL or less, 53 μg/mL or less, 52 μg/mL or less, 51 μg/mL or less , 50 μg/mL or less, 49 μg/mL or less, 48 μg/mL or less, 45 μg/mL or less, 40 μg/mL or less, 30 μg/mL or less, 20 μg/mL or less, 10 μg/mL or less, 9 μg/mL or less, 7 μg/mL or less, 5 μg/mL or less, 3 μg/mL or less, 1 μg/mL or less, 0.9 μg/mL or less, 0.7 μg/mL or less or 0.5 μg/mL or less.

本揭示內容之人參漿果提取物中所含的人參皂苷可由以下各項組成:人參皂苷Rb1、人參皂苷Rb2、人參皂苷Rb3、人參皂苷Rc、人參皂苷Rd、人參皂苷Re、人參皂苷Rg1或人參皂苷Rg2。 Ginsenosides contained in the ginseng berry extract of the present disclosure may consist of: ginsenoside Rb1, ginsenoside Rb2, ginsenoside Rb3, ginsenoside Rc, ginsenoside Rd, ginsenoside Re, ginsenoside Rg1 or ginsenoside Rg2.

在本揭示內容之一態樣中,人參漿果提取物可含有以人參漿果提取物之總重量計0.1-10wt%之以下各項中之每一者:人參皂苷Rb1、人參皂苷Rb2、人參皂苷Rb3、人參皂苷Rc、人參皂苷Rd、人參皂苷Rg1或人參皂苷Rg2。 In one aspect of the present disclosure, the ginseng berry extract may contain 0.1-10 wt% of each of the following items based on the total weight of the ginseng berry extract: ginsenoside Rb1, ginsenoside Rb2, ginsenoside Rb3 , ginsenoside Rc, ginsenoside Rd, ginsenoside Rg1 or ginsenoside Rg2.

具體而言,本揭示內容之人參漿果提取物可含有以人參漿果提取物之總重量計1.3-3.3wt%之人參皂苷Rb1。在上述範圍中達成本揭示內容之人參漿果提取物中各種成分之優異協同效應。在此態樣中,本揭示內容之人參漿果提取物可含有1.4wt%或更大、1.5wt%或更大、1.6wt%或更大、1.7wt%或更大或1.8wt%或更大及/或3.2wt%或更小、3.1wt%或更小、3.0wt%或更小、2.9wt%或更小或2.8wt%或更小之人參皂苷Rb1。 Specifically, the ginseng berry extract of the present disclosure may contain 1.3-3.3 wt% of ginsenoside Rb1 based on the total weight of the ginseng berry extract. The excellent synergistic effect of various components in the ginseng berry extract of the present disclosure is achieved within the above range. In this aspect, the ginseng berry extract of the present disclosure may contain 1.4 wt% or greater, 1.5 wt% or greater, 1.6 wt% or greater, 1.7 wt% or greater or 1.8 wt% or greater And/or 3.2wt% or less, 3.1wt% or less, 3.0wt% or less, 2.9wt% or less or 2.8wt% or less ginsenoside Rb1.

具體而言,本揭示內容之人參漿果提取物可含有以人參漿果提取物之總重量計1.5-3.5wt%之人 參皂苷Rb2。在上述範圍中達成本揭示內容之人參漿果提取物中各種成分之優異協同效應。在此態樣中,本揭示內容之人參漿果提取物可含有1.6wt%或更大、1.7wt%或更大、1.8wt%或更大、1.9wt%或更大或2.0wt%或更大及/或3.4wt%或更小、3.3wt%或更小、3.2wt%或更小、3.1wt%或更小或3.0wt%或更小之人參皂苷Rb2。 Specifically, the ginseng berry extract of the present disclosure may contain 1.5-3.5 wt% of ginseng berry extract based on the total weight of the ginseng berry extract Ginsenoside Rb2. The excellent synergistic effect of various components in the ginseng berry extract of the present disclosure is achieved within the above range. In this aspect, the ginseng berry extract of the present disclosure may contain 1.6 wt% or greater, 1.7 wt% or greater, 1.8 wt% or greater, 1.9 wt% or greater or 2.0 wt% or greater And/or 3.4wt% or less, 3.3wt% or less, 3.2wt% or less, 3.1wt% or less or 3.0wt% or less ginsenoside Rb2.

具體而言,本揭示內容之人參漿果提取物可含有以人參漿果提取物之總重量計0.2-1.2wt%之人參皂苷Rb3。在上述範圍中達成本揭示內容之人參漿果提取物中各種成分之優異協同效應。在此態樣中,本揭示內容之人參漿果提取物可含有0.2wt%或更大、0.3wt%或更大、0.4wt%或更大、0.5wt%或更大、0.6wt%或更大或0.7wt%或更大及/或1.5wt%或更小、1.4wt%或更小、1.3wt%或更小、1.2wt%或更小、1.1wt%或更小、1.0wt%或更小或0.9wt%或更小之人參皂苷Rb3。 Specifically, the ginseng berry extract of the present disclosure may contain 0.2-1.2 wt% of ginsenoside Rb3 based on the total weight of the ginseng berry extract. The excellent synergistic effect of various components in the ginseng berry extract of the present disclosure is achieved within the above range. In this aspect, the ginseng berry extract of the present disclosure may contain 0.2 wt% or greater, 0.3 wt% or greater, 0.4 wt% or greater, 0.5 wt% or greater, 0.6 wt% or greater or 0.7wt% or more and/or 1.5wt% or less, 1.4wt% or less, 1.3wt% or less, 1.2wt% or less, 1.1wt% or less, 1.0wt% or less Little or 0.9wt% or less ginsenoside Rb3.

具體而言,本揭示內容之人參漿果提取物可含有以人參漿果提取物之總重量計2.7-4.7wt%之人參皂苷Rc。在上述範圍中達成本揭示內容之人參漿果提取物中各種成分之優異協同效應。在此態樣中,本揭示內容之人參漿果提取物可含有2.8wt%或更大、2.9wt%或更大、3.0wt%或更大、3.1wt%或更大或3.2wt%或更大及/或4.7wt%或更小、4.6wt%或更小、 4.5wt%或更小、4.4wt%或更小或4.3wt%或更小之人參皂苷Rc。 Specifically, the ginseng berry extract of the present disclosure may contain 2.7-4.7 wt% of ginsenoside Rc based on the total weight of the ginseng berry extract. The excellent synergistic effect of various components in the ginseng berry extract of the present disclosure is achieved within the above range. In this aspect, the ginseng berry extract of the present disclosure may contain 2.8 wt% or greater, 2.9 wt% or greater, 3.0 wt% or greater, 3.1 wt% or greater or 3.2 wt% or greater and/or 4.7wt% or less, 4.6wt% or less, 4.5 wt% or less, 4.4 wt% or less, or 4.3 wt% or less of ginsenoside Rc.

具體而言,本揭示內容之人參漿果提取物可含有以人參漿果提取物之總重量計3.8-5.8wt%之人參皂苷Rd。在上述範圍中達成本揭示內容之人參漿果提取物中各種成分之優異協同效應。在此態樣中,本揭示內容之人參漿果提取物可含有3.9wt%或更大、4.0wt%或更大、4.1wt%或更大、4.2wt%或更大或4.3wt%或更大及/或5.7wt%或更小、5.6wt%或更小、5.5wt%或更小、5.4wt%或更小或5.3wt%或更小之人參皂苷Rd。 Specifically, the ginseng berry extract of the present disclosure may contain 3.8-5.8 wt% of ginsenoside Rd based on the total weight of the ginseng berry extract. The excellent synergistic effect of various components in the ginseng berry extract of the present disclosure is achieved within the above range. In this aspect, the ginseng berry extract of the present disclosure may contain 3.9 wt% or greater, 4.0 wt% or greater, 4.1 wt% or greater, 4.2 wt% or greater or 4.3 wt% or greater And/or 5.7wt% or less, 5.6wt% or less, 5.5wt% or less, 5.4wt% or less or 5.3wt% or less ginsenoside Rd.

具體而言,本揭示內容之人參漿果提取物可含有以人參漿果提取物之總重量計8.0-30.0wt%之人參皂苷Re。在上述範圍中達成本揭示內容之人參漿果提取物中各種成分之優異協同效應。在此態樣中,本揭示內容之人參漿果提取物可含有8.0wt%或更大、8.5wt%或更大、9.0wt%或更大、9.5wt%或更大、10.0wt%或更大、10.5wt%或更大、11.0wt%或更大、11.5wt%或更大、12.0wt%或更大、12.5wt%或更大、12.6wt%或更大、12.7wt%或更大、12.8wt%或更大、12.9wt%或更大、13.0wt%或更大、13.1wt%或更大、13.2wt%或更大、13.3wt%或更大、13.4wt%或更大、13.5wt%或更大、13.6wt%或更大、13.7wt%或更大、13.8wt%或更大、13.9wt% 或更大、14.0wt%或更大、15wt%或更大、20wt%或更大或25wt%或更大,及/或30wt%或更小、25wt%或更小、20wt%或更小、19.0wt%或更小、18.5wt%或更小、18.0wt%或更小、17.5wt%或更小、17.0wt%或更小、16.5wt%或更小、16.4wt%或更小、16.3wt%或更小、16.2wt%或更小、16.1wt%或更小、16.0wt%或更小、15.9wt%或更小、15.8wt%或更小、15.7wt%或更小、15.6wt%或更小、15.5wt%或更小、15.4wt%或更小、15.3wt%或更小、15.2wt%或更小、15.1wt%或更小或15.0wt%或更小之人參皂苷Re。 Specifically, the ginseng berry extract of the present disclosure may contain 8.0-30.0 wt% of ginsenoside Re based on the total weight of the ginseng berry extract. The excellent synergistic effect of various components in the ginseng berry extract of the present disclosure is achieved within the above range. In this aspect, the ginseng berry extract of the present disclosure may contain 8.0 wt% or greater, 8.5 wt% or greater, 9.0 wt% or greater, 9.5 wt% or greater, 10.0 wt% or greater , 10.5wt% or more, 11.0wt% or more, 11.5wt% or more, 12.0wt% or more, 12.5wt% or more, 12.6wt% or more, 12.7wt% or more, 12.8wt% or more, 12.9wt% or more, 13.0wt% or more, 13.1wt% or more, 13.2wt% or more, 13.3wt% or more, 13.4wt% or more, 13.5 wt% or more, 13.6wt% or more, 13.7wt% or more, 13.8wt% or more, 13.9wt% or greater, 14.0 wt% or greater, 15 wt% or greater, 20 wt% or greater, or 25 wt% or greater, and/or 30 wt% or less, 25 wt% or less, 20 wt% or less, 19.0wt% or less, 18.5wt% or less, 18.0wt% or less, 17.5wt% or less, 17.0wt% or less, 16.5wt% or less, 16.4wt% or less, 16.3 wt% or less, 16.2wt% or less, 16.1wt% or less, 16.0wt% or less, 15.9wt% or less, 15.8wt% or less, 15.7wt% or less, 15.6wt % or less, 15.5wt% or less, 15.4wt% or less, 15.3wt% or less, 15.2wt% or less, 15.1wt% or less or 15.0wt% or less .

具體而言,本揭示內容之人參漿果提取物可含有以人參漿果提取物之總重量計2.2-4.2wt%之人參皂苷Rg1。在上述範圍中達成本揭示內容之人參漿果提取物中各種成分之優異協同效應。在此態樣中,本揭示內容之人參漿果提取物可含有2.3wt%或更大、2.4wt%或更大、2.5wt%或更大、2.6wt%或更大或2.7wt%或更大及/或4.3wt%或更小、4.2wt%或更小、4.1wt%或更小、4.0wt%或更小或3.9wt%或更小之人參皂苷Rg1。 Specifically, the ginseng berry extract of the present disclosure may contain 2.2-4.2 wt% of ginsenoside Rg1 based on the total weight of the ginseng berry extract. The excellent synergistic effect of various components in the ginseng berry extract of the present disclosure is achieved within the above range. In this aspect, the ginseng berry extract of the present disclosure may contain 2.3 wt% or greater, 2.4 wt% or greater, 2.5 wt% or greater, 2.6 wt% or greater or 2.7 wt% or greater And/or 4.3wt% or less, 4.2wt% or less, 4.1wt% or less, 4.0wt% or less or 3.9wt% or less ginsenoside Rg1.

具體而言,本揭示內容之人參漿果提取物可含有以人參漿果提取物之總重量計0.5-2.5wt%之人參皂苷Rg2。在上述範圍中達成本揭示內容之人參漿果提取物中各種成分之優異協同效應。在此態樣中,本揭 示內容之人參漿果提取物0.6wt%或更大、0.7wt%或更大、0.8wt%或更大、0.9wt%或更大或1.0wt%或更大及/或2.4wt%或更小、2.3wt%或更小、2.2wt%或更小、2.1wt%或更小或2.0wt%或更小之人參皂苷Rg2。 Specifically, the ginseng berry extract of the present disclosure may contain 0.5-2.5 wt% of ginsenoside Rg2 based on the total weight of the ginseng berry extract. The excellent synergistic effect of various components in the ginseng berry extract of the present disclosure is achieved within the above range. In this form, the disclosure 0.6wt% or greater, 0.7wt% or greater, 0.8wt% or greater, 0.9wt% or greater or 1.0wt% or greater and/or 2.4wt% or less , 2.3wt% or less, 2.2wt% or less, 2.1wt% or less or 2.0wt% or less ginsenoside Rg2.

因此,本揭示內容之人參漿果提取物可含有以人參漿果提取物之總重量計23.0-80.0wt%之總人參皂苷。在上述範圍中達成本揭示內容之人參漿果提取物中各種成分之優異協同效應。在本揭示內容中,總人參皂苷可意指存在於人參漿果提取物中之所有人參皂苷成分。例如,總人參皂苷可意指人參皂苷Rb1、Rb2、Rb3、Rc、Rd、Re、Rg1及Rg2之總和。 Accordingly, the ginseng berry extract of the present disclosure may contain 23.0-80.0 wt% total ginsenosides based on the total weight of the ginseng berry extract. The excellent synergistic effect of various components in the ginseng berry extract of the present disclosure is achieved within the above range. In the present disclosure, total ginsenosides may mean all ginsenoside components present in ginseng berry extract. For example, total ginsenosides may mean the sum of ginsenosides Rb1, Rb2, Rb3, Rc, Rd, Re, Rg1, and Rg2.

在此態樣中,本揭示內容之人參漿果提取物可含有以人參漿果提取物之總重量計23.0wt%或更大、24.0wt%或更大、25.0wt%或更大、25.5wt%或更大、26.0wt%或更大、26.5wt%或更大、27wt%或更大、27.5wt%或更大、28.0wt%或更大、28.5wt%或更大、29.0wt%或更大、29.5wt%或更大、30.0wt%或更大、30.5wt%或更大、31.0wt%或更大、31.5wt%或更大、32.0wt%或更大、35wt%或更大、40wt%或更大、45wt%或更大、50wt%或更大、55wt%或更大、60wt%或更大、65wt%或更大、70wt%或更大、75wt%或更大或80wt%或更大,及/或80wt%或更小、75wt%或更小、70wt%或更 小、65wt%或更小、60wt%或更小、55wt%或更小、50wt%或更小、45wt%或更小、41.0wt%或更小、40.5wt%或更小、40wt%或更小、39.5wt%或更小、39wt%或更小、38.5wt%或更小、38wt%或更小、37.5wt%或更小、37wt%或更小、36.5wt%或更小、36wt%或更小、35.5wt%或更小、35.0wt%或更小、34.5wt%或更小或34.0wt%或更小之人參皂苷。 In this aspect, the ginseng berry extract of the present disclosure may contain 23.0 wt% or greater, 24.0 wt% or greater, 25.0 wt% or greater, 25.5 wt% or Greater, 26.0 wt% or greater, 26.5 wt% or greater, 27 wt% or greater, 27.5 wt% or greater, 28.0 wt% or greater, 28.5 wt% or greater, 29.0 wt% or greater , 29.5wt% or more, 30.0wt% or more, 30.5wt% or more, 31.0wt% or more, 31.5wt% or more, 32.0wt% or more, 35wt% or more, 40wt % or more, 45wt% or more, 50wt% or more, 55wt% or more, 60wt% or more, 65wt% or more, 70wt% or more, 75wt% or more or 80wt% or Greater, and/or 80wt% or less, 75wt% or less, 70wt% or less Small, 65wt% or less, 60wt% or less, 55wt% or less, 50wt% or less, 45wt% or less, 41.0wt% or less, 40.5wt% or less, 40wt% or less Small, 39.5wt% or less, 39wt% or less, 38.5wt% or less, 38wt% or less, 37.5wt% or less, 37wt% or less, 36.5wt% or less, 36wt% or less, 35.5wt% or less, 35.0wt% or less, 34.5wt% or less or 34.0wt% or less ginsenosides.

本揭示內容之人參漿果提取物可具有0.5-2.5的基於原人參二醇(protopanaxadiol;PD)的人參皂苷(Rb1、Rb2、Rc及Rd)與基於原人參三醇(protopanaxatriol;PT)的人參皂苷(Re、Rg1及Rg2)即PD/PT之比率。在上述溫度範圍中達成本揭示內容之人參漿果提取物中各種成分之優異協同效應。在此態樣中,本揭示內容之人參漿果提取物可具有以下PD人參皂苷與PT人參皂苷即PD/PT之比率:0.1或更大、0.15或更大、0.2或更大、0.25或更大、0.3或更大、0.35或更大、0.4或更大、0.45或更大、0.5或更大、0.55或更大、0.6或更大、0.61或更大、0.62或更大、0.63或更大、0.64或更大、0.65或更大、0.69或更大、0.7或更大、0.73或更大、0.75或更大、0.8或更大、0.85或更大、0.9或更大、0.95或更大、1.0或更大、1.1或更大、1.3或更大、1.5或更大、1.7或更大、1.9或更大、2.1或更大、2.3或更大、2.5或更大或2.6或 更大,及2.7或更小、2.5或更小、2.4或更小、2.2或更小、2.0或更小、1.8或更小、1.7或更小、1.5或更小、1.3或更小、1.25或更小、1.24或更小、1.23或更小、1.22或更小、1.21或更小、1.20或更小、1.05或更小、1.0或更小、0.95或更小、0.9或更小、0.85或更小、0.8或更小、0.75或更小、0.73或更小、0.7或更小、0.69或更小、0.65或更小、0.6或更小、0.55或更小、0.5或更小、0.45或更小、0.4或更小、0.3或更小、0.2或更小或0.1或更小。具體而言,本揭示內容之人參漿果提取物可具有以下PD人參皂苷與PT人參皂苷即PD/PT之比率:0.55-2.45、0.6-2.4、0.65-2.35或0.7-2.3。 Ginseng berry extracts of the present disclosure may have 0.5-2.5 protopanaxadiol (PD)-based ginsenosides (Rb1, Rb2, Rc, and Rd) and protopanaxatriol (PT)-based ginsenosides (Re, Rg1 and Rg2) is the ratio of PD/PT. The excellent synergistic effect of the various components in the ginseng berry extract of the present disclosure is achieved in the above temperature range. In this aspect, the ginseng berry extract of the present disclosure may have the following ratio of PD ginsenosides to PT ginsenosides, PD/PT: 0.1 or greater, 0.15 or greater, 0.2 or greater, 0.25 or greater , 0.3 or greater, 0.35 or greater, 0.4 or greater, 0.45 or greater, 0.5 or greater, 0.55 or greater, 0.6 or greater, 0.61 or greater, 0.62 or greater, 0.63 or greater , 0.64 or greater, 0.65 or greater, 0.69 or greater, 0.7 or greater, 0.73 or greater, 0.75 or greater, 0.8 or greater, 0.85 or greater, 0.9 or greater, 0.95 or greater , 1.0 or greater, 1.1 or greater, 1.3 or greater, 1.5 or greater, 1.7 or greater, 1.9 or greater, 2.1 or greater, 2.3 or greater, 2.5 or greater, or 2.6 or greater Greater, and 2.7 or less, 2.5 or less, 2.4 or less, 2.2 or less, 2.0 or less, 1.8 or less, 1.7 or less, 1.5 or less, 1.3 or less, 1.25 or less, 1.24 or less, 1.23 or less, 1.22 or less, 1.21 or less, 1.20 or less, 1.05 or less, 1.0 or less, 0.95 or less, 0.9 or less, 0.85 or less, 0.8 or less, 0.75 or less, 0.73 or less, 0.7 or less, 0.69 or less, 0.65 or less, 0.6 or less, 0.55 or less, 0.5 or less, 0.45 or less, 0.4 or less, 0.3 or less, 0.2 or less, or 0.1 or less. Specifically, the ginseng berry extract of the present disclosure may have the following ratio of PD ginsenosides to PT ginsenosides, PD/PT: 0.55-2.45, 0.6-2.4, 0.65-2.35, or 0.7-2.3.

在本揭示內容之一態樣中,人參漿果提取物可進一步含有維生素、礦物質及花青素。 In one aspect of the present disclosure, the ginseng berry extract may further contain vitamins, minerals and anthocyanins.

在本揭示內容之一態樣中,礦物質可包括以人參漿果提取物之總重量計以下一或多者:4000mg/100g或更大之鉀、600mg/100g或更大之鈣、40mg/100g或更大之鐵、150mg/100g或更大之磷、250mg/100g或更大之鎂及140mg/100g或更大之鋅。 In an aspect of the present disclosure, the minerals may include one or more of the following based on the total weight of the ginseng berry extract: 4000 mg/100 g or greater potassium, 600 mg/100 g or greater calcium, 40 mg/100 g or greater iron, 150mg/100g or greater phosphorus, 250mg/100g or greater magnesium, and 140mg/100g or greater zinc.

在本揭示內容之一態樣中,人參漿果提取物可含有4000mg/100g至10g/100g之鉀、600mg/100g至5g/100g之鈣、40mg/100g至1g/100g之鐵、150mg/100g至1g/100g之磷、250mg/100 g至5g/100g之鎂及140mg/100g至5g/100g之鋅,但不限於此。 In one aspect of the present disclosure, the ginseng berry extract may contain 4000mg/100g to 10g/100g of potassium, 600mg/100g to 5g/100g of calcium, 40mg/100g to 1g/100g of iron, 150mg/100g to 1g/100g of phosphorus, 250mg/100 g to 5g/100g of magnesium and 140mg/100g to 5g/100g of zinc, but not limited thereto.

在本揭示內容之一態樣中,維生素可包括以人參漿果提取物之總重量計以下一或多者:150μg/100g或更大之維生素A、8mg/100g或更大之維生素B1、5mg/100g或更大之維生素B2、8mg/100g或更大之維生素B6、3mg/100g或更大之維生素C、180μg/100g或更大之維生素K、3.5mg/100g或更大之菸酸、4mg/100g或更大之泛酸及250μg/100g或更大之葉酸。 In an aspect of the present disclosure, the vitamins may include one or more of the following based on the total weight of the ginseng berry extract: 150 μg/100 g or greater vitamin A, 8 mg/100 g or greater vitamin B 1 , 5 mg Vitamin B2 /100g or greater, vitamin B6 8mg/100g or greater, vitamin C 3mg /100g or greater, vitamin K 180μg/100g or greater, smoke 3.5mg/100g or greater Acid, 4mg/100g or greater pantothenic acid and 250μg/100g or greater folic acid.

在本揭示內容之一態樣中,人參漿果提取物可含有150μg/100g至20mg/100g之維生素A、8mg/100g至5g/100g之維生素B1、5mg/100g至5g/100g之維生素B2、8mg/100g至5g/100g之維生素B6、3mg/100g至5g/100g之維生素C、180μg/100g至20mg/100g之維生素K、3.5mg/100g至5g/100g之菸酸、4mg/100g至5g/100g之泛酸及250μg/100g至20mg/100g之葉酸,但不限於此。 In one aspect of the present disclosure, the ginseng berry extract may contain 150μg/100g to 20mg/100g vitamin A, 8mg/100g to 5g/100g vitamin B1 , 5mg/100g to 5g/100g vitamin B2 , Vitamin B 6 from 8mg/100g to 5g/100g, Vitamin C from 3mg/100g to 5g/100g, Vitamin K from 180μg/100g to 20mg/100g, Niacin from 3.5mg/100g to 5g/100g, 4mg/100g Up to 5g/100g of pantothenic acid and 250μg/100g to 20mg/100g of folic acid, but not limited thereto.

另外,本揭示內容之人參漿果提取物可含有選自花青素化合物、其衍生物及其鹽之一或多種化合物。具體而言,花青素化合物可包括選自由氯化錦葵色素、氯化矢車菊素半乳糖苷(ideain chloride)、氯化天竺葵素及氯化花青素鼠李葡糖苷組成。 In addition, the ginseng berry extract of the present disclosure may contain one or more compounds selected from the group consisting of anthocyanin compounds, their derivatives and their salts. Specifically, the anthocyanin compound may be selected from the group consisting of mallow chloride chloride, ideain chloride chloride, geranium chloride and anthocyanin rhamnoside chloride.

在本揭示內容之一態樣中,人參漿果提取物可含有以人參漿果提取物之總重量計8.0-16.0ppm(w/w)之氯化錦葵色素、1.0-5.0ppm(w/w)之氯化矢車菊素半乳糖苷、6.0-12.0ppm(w/w)之氯化天竺葵素及2.0-6.0ppm(w/w)之氯化花青素鼠李葡糖苷。 In one aspect of the present disclosure, the ginseng berry extract may contain 8.0-16.0 ppm (w/w) of chlorinated mallow pigment, 1.0-5.0 ppm (w/w) based on the total weight of the ginseng berry extract. Chlorinated cyanidin galactoside, 6.0-12.0ppm (w/w) chlorinated geranium and 2.0-6.0ppm (w/w) chlorinated anthocyanin rhamnoside.

在本揭示內容之一態樣中,人參漿果提取物可含有以人參漿果提取物之總重量計8.0ppm(w/w)或更大、9.0ppm(w/w)或更大、10.0ppm(w/w)或更大、11.0ppm(w/w)或更大、12.0ppm(w/w)或更大、12.5.0ppm(w/w)或更大、13.0ppm(w/w)或更大、14.0ppm(w/w)或更大、15.0ppm(w/w)或更大或16.0ppm(w/w)或更大,及/或16.0ppm(w/w)或更小、15.0ppm(w/w)或更小、14.0ppm(w/w)或更小、13.0ppm(w/w)或更小、12.5ppm(w/w)或更小、12.0ppm(w/w)或更小、11.0ppm(w/w)或更小、10.0ppm(w/w)或更小、9.0ppm(w/w)或更小或8.0ppm(w/w)或更小之氯化錦葵色素。 In one aspect of the present disclosure, the ginseng berry extract may contain 8.0 ppm (w/w) or more, 9.0 ppm (w/w) or more, 10.0 ppm ( w/w) or greater, 11.0ppm (w/w) or greater, 12.0ppm (w/w) or greater, 12.5.0ppm (w/w) or greater, 13.0ppm (w/w) or Greater, 14.0ppm(w/w) or greater, 15.0ppm(w/w) or greater, or 16.0ppm(w/w) or greater, and/or 16.0ppm(w/w) or less, 15.0ppm(w/w) or less, 14.0ppm(w/w) or less, 13.0ppm(w/w) or less, 12.5ppm(w/w) or less, 12.0ppm(w/w) ) or less, 11.0 ppm (w/w) or less, 10.0 ppm (w/w) or less, 9.0 ppm (w/w) or less, or 8.0 ppm (w/w) or less chlorine Chemical mallow pigment.

在本揭示內容之一態樣中,人參漿果提取物可含有以人參漿果提取物之總重量計0.1ppm(w/w)或更大、1.0ppm(w/w)或更大、2.0ppm(w/w)或更大、2.2ppm(w/w)或更大、2.4ppm(w/w)或更大、2.5ppm(w/w)或更大、3.0ppm(w/w)或更大、4.0ppm(w/w)或更大或5.0ppm(w/w) 或更大,及/或5.0ppm(w/w)或更小、4.0ppm(w/w)或更小、3.0ppm(w/w)或更小、2.5ppm(w/w)或更小、2.4ppm(w/w)或更小、2.2ppm(w/w)或更小、2.0ppm(w/w)或更小、1.0ppm(w/w)或更小或0.1ppm(w/w)或更小之氯化矢車菊素半乳糖苷。 In one aspect of the present disclosure, the ginseng berry extract may contain 0.1 ppm (w/w) or more, 1.0 ppm (w/w) or more, 2.0 ppm ( w/w) or greater, 2.2ppm (w/w) or greater, 2.4ppm (w/w) or greater, 2.5ppm (w/w) or greater, 3.0ppm (w/w) or greater Large, 4.0ppm(w/w) or greater or 5.0ppm(w/w) or greater, and/or 5.0ppm(w/w) or less, 4.0ppm(w/w) or less, 3.0ppm(w/w) or less, 2.5ppm(w/w) or less , 2.4ppm(w/w) or less, 2.2ppm(w/w) or less, 2.0ppm(w/w) or less, 1.0ppm(w/w) or less or 0.1ppm(w/w) w) or smaller chlorinated cyanidin galactosides.

在本揭示內容之一態樣中,人參漿果提取物可含有以人參漿果提取物之總重量計6.0ppm(w/w)或更大、7.0ppm(w/w)或更大、7.5ppm(w/w)或更大、8.0ppm(w/w)或更大、8.5ppm(w/w)或更大、9.0ppm(w/w)或更大、10.0ppm(w/w)或更大、11.0ppm(w/w)或更大或12.0ppm(w/w)或更大,及/或12.0ppm(w/w)或更小、11.0ppm(w/w)或更小、10.0ppm(w/w)或更小、9.0ppm(w/w)或更小、8.5ppm(w/w)或更小、8.0ppm(w/w)或更小、7.5ppm(w/w)或更小、7.0ppm(w/w)或更小或6.0ppm(w/w)或更小之氯化天竺葵素。 In one aspect of the present disclosure, the ginseng berry extract may contain 6.0 ppm (w/w) or more, 7.0 ppm (w/w) or more, 7.5 ppm ( w/w) or greater, 8.0ppm (w/w) or greater, 8.5ppm (w/w) or greater, 9.0ppm (w/w) or greater, 10.0ppm (w/w) or greater Large, 11.0ppm(w/w) or greater or 12.0ppm(w/w) or greater, and/or 12.0ppm(w/w) or less, 11.0ppm(w/w) or less, 10.0 ppm(w/w) or less, 9.0ppm(w/w) or less, 8.5ppm(w/w) or less, 8.0ppm(w/w) or less, 7.5ppm(w/w) or less, 7.0 ppm (w/w) or less, or 6.0 ppm (w/w) or less geranium chloride.

在本揭示內容之一態樣中,人參漿果提取物可含有以人參漿果提取物之總重量計2.0ppm(w/w)或更大、2.5ppm(w/w)或更大、3.0ppm(w/w)或更大、3.5ppm(w/w)或更大、4.0ppm(w/w)或更大、5.0ppm(w/w)或更大或6.0ppm(w/w)或更大,及/或6.0ppm(w/w)或更小、5.0ppm(w/w) 或更小、4.0ppm(w/w)或更小、3.5ppm(w/w)或更小、3.0ppm(w/w)或更小、2.5ppm(w/w)或更小或2.0ppm(w/w)或更小之氯化花青素鼠李葡糖苷。 In one aspect of the present disclosure, the ginseng berry extract may contain 2.0 ppm (w/w) or more, 2.5 ppm (w/w) or more, 3.0 ppm ( w/w) or greater, 3.5ppm (w/w) or greater, 4.0ppm (w/w) or greater, 5.0ppm (w/w) or greater, or 6.0ppm (w/w) or greater large, and/or 6.0ppm(w/w) or less, 5.0ppm(w/w) or less, 4.0ppm(w/w) or less, 3.5ppm(w/w) or less, 3.0ppm(w/w) or less, 2.5ppm(w/w) or less or 2.0ppm (w/w) or smaller chlorinated anthocyanin rhamnoglucoside.

在本揭示內容之一態樣中,組合物可含有以100重量份之人參漿果提取物計0.01-1重量份之白蛋白。具體而言,組合物可含有0.001重量份或更大、0.003重量份或更大、0.005重量份或更大、0.007重量份或更大、0.009重量份或更大、0.01重量份或更大、0.03重量份或更大、0.05重量份或更大、0.07重量份或更大、0.09重量份或更大、0.1重量份或更大、0.11重量份或更大、0.12重量份或更大、0.13重量份或更大、0.13重量份或更大、0.18重量份或更大、0.2重量份或更大、0.3重量份或更大、0.4重量份或更大、0.5重量份或更大、0.6重量份或更大、0.7重量份或更大、0.8重量份或更大、0.9重量份或更大、1.0重量份或更大或1.1重量份或更大及1.05重量份或更小、1.0重量份或更小、0.9重量份或更小、0.85重量份或更小、0.75重量份或更小、0.65重量份或更小、0.55重量份或更小、0.45重量份或更小、0.35重量份或更小、0.25重量份或更小、0.15重量份或更小、0.13重量份或更小、0.12重量份或更小、0.11重量份或更小、0.10重量份或更小、0.09重量份或更小、0.08重量份或更小、0.07重量份或更小、0.06重量份或更小、0.05重量份 或更小、0.04重量份或更小、0.03重量份或更小、0.02重量份或更小、0.01重量份或更小、0.009重量份或更小或0.008重量份或更小之白蛋白。 In one aspect of the present disclosure, the composition may contain 0.01-1 part by weight of albumin based on 100 parts by weight of ginseng berry extract. Specifically, the composition may contain 0.001 parts by weight or more, 0.003 parts by weight or more, 0.005 parts by weight or more, 0.007 parts by weight or more, 0.009 parts by weight or more, 0.01 parts by weight or more, 0.03 parts by weight or more, 0.05 parts by weight or more, 0.07 parts by weight or more, 0.09 parts by weight or more, 0.1 parts by weight or more, 0.11 parts by weight or more, 0.12 parts by weight or more, 0.13 parts by weight Parts by weight or more, 0.13 parts by weight or more, 0.18 parts by weight or more, 0.2 parts by weight or more, 0.3 parts by weight or more, 0.4 parts by weight or more, 0.5 parts by weight or more, 0.6 parts by weight parts by weight or more, 0.7 parts by weight or more, 0.8 parts by weight or more, 0.9 parts by weight or more, 1.0 parts by weight or more, or 1.1 parts by weight or more and 1.05 parts by weight or less, 1.0 parts by weight or less, 0.9 parts by weight or less, 0.85 parts by weight or less, 0.75 parts by weight or less, 0.65 parts by weight or less, 0.55 parts by weight or less, 0.45 parts by weight or less, 0.35 parts by weight or Smaller, 0.25 parts by weight or less, 0.15 parts by weight or less, 0.13 parts by weight or less, 0.12 parts by weight or less, 0.11 parts by weight or less, 0.10 parts by weight or less, 0.09 parts by weight or less Small, 0.08 parts by weight or less, 0.07 parts by weight or less, 0.06 parts by weight or less, 0.05 parts by weight or less, 0.04 parts by weight or less, 0.03 parts by weight or less, 0.02 parts by weight or less, 0.01 parts by weight or less, 0.009 parts by weight or less, or 0.008 parts by weight or less of albumin.

在本揭示內容之一態樣中,組合物可為醫藥組合物。根據本揭示內容之一態樣的醫藥組合物可藉由添加無機或有機載劑而製備成用於經口投藥或非經腸投藥的固體、半固體或液體調配物。 In one aspect of the disclosure, the composition can be a pharmaceutical composition. The pharmaceutical composition according to an aspect of the present disclosure can be prepared as a solid, semi-solid or liquid formulation for oral administration or parenteral administration by adding inorganic or organic carriers.

用於經口投藥之調配物包括錠劑、丸劑、顆粒、軟膠囊或硬膠囊、粉末、微粒劑、粉劑、乳劑、糖漿、小丸劑等。用於非經腸投藥之調配物包括注射劑、醫學滴劑、軟膏、洗劑、噴劑、懸浮液、乳劑、栓劑等。根據本揭示內容之一態樣的組合物可容易根據常見方法而調配。可適當地使用表面活性劑、賦形劑、著色劑、芳香劑、防腐劑、穩定劑、緩衝劑、懸浮劑或另一常用佐藥。 Formulations for oral administration include tablets, pills, granules, soft or hard capsules, powders, granules, powders, emulsions, syrups, pellets and the like. Formulations for parenteral administration include injections, medical drops, ointments, lotions, sprays, suspensions, emulsions, suppositories, and the like. Compositions according to one aspect of the present disclosure can be readily formulated according to common methods. Surfactants, excipients, colorants, fragrances, preservatives, stabilizers, buffers, suspending agents or another usual adjuvant may be used as appropriate.

根據本揭示內容之一態樣的組合物中所含的活性成分可藉由與載劑混合而提供,或囊封於容器型載劑中。當稀釋劑用作載劑時,稀釋劑可為可充當用於活性成分之載劑、賦形劑或介質的固體、半固體或液體物質。適合載劑、賦形劑或稀釋劑之實例包括乳糖、葡萄糖、蔗糖、山梨糖醇、甘露糖醇、矽酸鈣、纖維素、甲基纖維素、微晶纖維素、聚乙烯吡咯啶酮、水、羥基苯甲酸甲酯、羥基苯甲酸丙酯、滑石、硬脂酸鎂或礦物油。在本揭示內容之另一態樣中,組合物可進一步含有填充 劑、抗凝聚劑、潤滑劑、濕潤劑、芳香劑、乳化劑、殺菌劑等。 The active ingredient contained in a composition according to an aspect of the present disclosure may be provided by mixing with a carrier, or encapsulated in a container-type carrier. When a diluent is used as a carrier, the diluent can be a solid, semi-solid or liquid material that can act as a carrier, excipient or medium for the active ingredient. Examples of suitable carriers, excipients or diluents include lactose, dextrose, sucrose, sorbitol, mannitol, calcium silicate, cellulose, methylcellulose, microcrystalline cellulose, polyvinylpyrrolidone, Water, methylparaben, propylparaben, talc, magnesium stearate or mineral oil. In another aspect of the present disclosure, the composition may further contain filler Agents, anti-coagulants, lubricants, wetting agents, fragrances, emulsifiers, fungicides, etc.

根據本揭示內容之一態樣的醫藥組合物可提供為調配物,該調配物以在使用此項技術中熟知的方法投與至哺乳動物中之後快速、持續或延遲方式遞送活性成分。 Pharmaceutical compositions according to one aspect of the present disclosure may be provided as formulations that deliver the active ingredient in a rapid, sustained or delayed manner following administration to a mammal using methods well known in the art.

根據本揭示內容之一態樣的醫藥組合物可經由各種路線投與,該等路線包括而不限於經口、透皮、皮下、靜脈內、腹膜內、肌肉內、局部或離子導入路線。在本揭示內容之另一態樣中,醫藥組合物可局部或經口投與。 Pharmaceutical compositions according to an aspect of the present disclosure may be administered via various routes including, without limitation, oral, transdermal, subcutaneous, intravenous, intraperitoneal, intramuscular, topical or iontophoresis routes. In another aspect of the disclosure, the pharmaceutical composition can be administered topically or orally.

對哺乳動物而言,活性成分之每日投藥劑量可通常為1-2000mg/kg(體重),更具體而言1-1800mg/kg(體重)、1-1500mg/kg(體重)、1-1000mg/kg(體重)、1-800mg/kg(體重)、1-600mg/kg(體重)、1-400mg/kg(體重)、1-200mg/kg(體重)、1-100mg/kg(體重)、5-100mg/kg(體重)或5-70mg/kg(體重)且可一天投與一次或數次。然而,應理解:活性成分之實際投藥劑量可考慮各種有關因素而決定,該等因素包括待治療之疾病、投藥路線、患者之年齡、性別及體重、疾病嚴重性等,且上述投藥劑量不以任何方式限制本揭示內容之範疇。 For mammals, the daily dosage of the active ingredient can usually be 1-2000mg/kg (body weight), more specifically 1-1800mg/kg (body weight), 1-1500mg/kg (body weight), 1-1000mg /kg (body weight), 1-800mg/kg (body weight), 1-600mg/kg (body weight), 1-400mg/kg (body weight), 1-200mg/kg (body weight), 1-100mg/kg (body weight) , 5-100 mg/kg (body weight) or 5-70 mg/kg (body weight) and can be administered once or several times a day. However, it should be understood that the actual dosage of the active ingredient can be determined by considering various relevant factors, such factors include the disease to be treated, the route of administration, the patient's age, sex and body weight, and the severity of the disease, etc., and the above-mentioned dosage is not based on Limit the scope of this disclosure in any way.

在本揭示內容之另一態樣中,組合物可為食品組合物。根據本揭示內容之一態樣的食品組合物包括 食品添加劑組合物或健康食品組合物,且可使用常用於此項技術中之成分而製備為錠劑、硬膠囊、軟膠囊、丸劑、顆粒、飲料、膳食棒、巧克力、焦糖、糖果甜點等。此外,健康食品組合物可進一步含有足夠的功能成分。 In another aspect of the disclosure, the composition can be a food composition. A food composition according to one aspect of the present disclosure includes Food additive composition or health food composition, and can be prepared as lozenges, hard capsules, soft capsules, pills, granules, beverages, meal bars, chocolate, caramel, confectionery, etc. using ingredients commonly used in this technology . In addition, the health food composition may further contain sufficient functional ingredients.

在另一態樣中,本揭示內容提供含有以下各項之癌症疫苗套組:含有白蛋白之組合物;含有人參漿果提取物之組合物;和說明書,其中該說明書描述含有白蛋白之組合物及含有人參漿果提取物之組合物的同時投藥方法。 In another aspect, the disclosure provides a cancer vaccine kit comprising: a composition comprising albumin; a composition comprising ginseng berry extract; and instructions, wherein the instructions describe the composition comprising albumin And the simultaneous administration method of the composition containing the ginseng berry extract.

含有白蛋白之組合物之投藥劑量可為0.001-0.1mg/kg/日,且含有人參漿果提取物之組合物之投藥劑量可為1-100mg/kg/日。具體而言,含有白蛋白之組合物之投藥劑量可為0.0001mg/kg/日或更大、0.0007mg/kg/日或更大、0.0009mg/kg/日或更大、0.001mg/kg/日或更大、0.003mg/kg/日或更大、0.005mg/kg/日或更大、0.007mg/kg/日或更大、0.009mg/kg/日或更大、0.01mg/kg/日或更大、0.015mg/kg/日或更大、0.03mg/kg/日或更大、0.05mg/kg/日或更大、0.07mg/kg/日或更大、0.08mg/kg/日或更大、0.09mg/kg/日或更大、0.1mg/kg/日或更大或0.11mg/kg/日或更大,及0.12mg/kg/日或更小、0.1mg/kg/日或更小、0.09mg/kg/日或更小、0.08mg/kg/日或更小、0.06mg/kg/日或更小、0.04mg/kg/日或更小、0.02 mg/kg/日或更小、0.01mg/kg/日或更小、0.008mg/kg/日或更小、0.006mg/kg/日或更小、0.004mg/kg/日或更小、0.002mg/kg/日或更小、0.001mg/kg/日或更小、0.0009mg/kg/日或更小或0.0008mg/kg/日或更小。此外,含有人參漿果提取物之組合物之投藥劑量可為0.5mg/kg/日或更大、0.7mg/kg/日或更大、0.8mg/kg/日或更大、0.9mg/kg/日或更大、1.0mg/kg/日或更大、1.1mg/kg/日或更大、5mg/kg/日或更大、9mg/kg/日或更大、10mg/kg/日或更大、11mg/kg/日或更大、16mg/kg/日或更大、21mg/kg/日或更大、26mg/kg/日或更大、31mg/kg/日或更大、36mg/kg/日或更大、41mg/kg/日或更大、46mg/kg/日或更大、48mg/kg/日或更大、49mg/kg/日或更大、50mg/kg/日或更大、51mg/kg/日或更大、52mg/kg/日或更大、57mg/kg/日或更大、61mg/kg/日或更大、66mg/kg/日或更大、71mg/kg/日或更大、76mg/kg/日或更大、81mg/kg/日或更大、86mg/kg/日或更大、91mg/kg/日或更大、96mg/kg/日或更大、98mg/kg/日或更大、99mg/kg/日或更大、100mg/kg/日或更大或101mg/kg/日或更大,及102mg/kg/日或更小、101mg/kg/日或更小、100mg/kg/日或更小、99mg/kg/日或更小、98mg/kg/日或更小、90mg/kg/日或更小、85mg/kg/日或更小、80mg/kg/日或更 小、75mg/kg/日或更小、70mg/kg/日或更小、65mg/kg/日或更小、60mg/kg/日或更小、55mg/kg/日或更小、54mg/kg/日或更小、53mg/kg/日或更小、52mg/kg/日或更小、51mg/kg/日或更小、50mg/kg/日或更小、49mg/kg/日或更小、48mg/kg/日或更小、43mg/kg/日或更小、38mg/kg/日或更小、33mg/kg/日或更小、28mg/kg/日或更小、23mg/kg/日或更小、18mg/kg/日或更小、15mg/kg/日或更小、13mg/kg/日或更小、12mg/kg/日或更小、11mg/kg/日或更小、10mg/kg/日或更小、9mg/kg/日或更小或8mg/kg/日或更小。 The dosage of the composition containing albumin can be 0.001-0.1 mg/kg/day, and the dosage of the composition containing ginseng berry extract can be 1-100 mg/kg/day. Specifically, the dosage of the composition containing albumin can be 0.0001 mg/kg/day or more, 0.0007 mg/kg/day or more, 0.0009 mg/kg/day or more, 0.001 mg/kg/day or more, day or greater, 0.003mg/kg/day or greater, 0.005mg/kg/day or greater, 0.007mg/kg/day or greater, 0.009mg/kg/day or greater, 0.01mg/kg/day day or greater, 0.015mg/kg/day or greater, 0.03mg/kg/day or greater, 0.05mg/kg/day or greater, 0.07mg/kg/day or greater, 0.08mg/kg/day or greater, 0.09 mg/kg/day or greater, 0.1 mg/kg/day or greater, or 0.11 mg/kg/day or greater, and 0.12 mg/kg/day or less, 0.1 mg/kg /day or less, 0.09mg/kg/day or less, 0.08mg/kg/day or less, 0.06mg/kg/day or less, 0.04mg/kg/day or less, 0.02 mg/kg/day or less, 0.01mg/kg/day or less, 0.008mg/kg/day or less, 0.006mg/kg/day or less, 0.004mg/kg/day or less, 0.002 mg/kg/day or less, 0.001 mg/kg/day or less, 0.0009 mg/kg/day or less, or 0.0008 mg/kg/day or less. In addition, the dosage of the composition containing ginseng berry extract can be 0.5 mg/kg/day or more, 0.7 mg/kg/day or more, 0.8 mg/kg/day or more, 0.9 mg/kg/day or more, day or greater, 1.0mg/kg/day or greater, 1.1mg/kg/day or greater, 5mg/kg/day or greater, 9mg/kg/day or greater, 10mg/kg/day or greater Large, 11 mg/kg/day or greater, 16 mg/kg/day or greater, 21 mg/kg/day or greater, 26 mg/kg/day or greater, 31 mg/kg/day or greater, 36 mg/kg /day or greater, 41mg/kg/day or greater, 46mg/kg/day or greater, 48mg/kg/day or greater, 49mg/kg/day or greater, 50mg/kg/day or greater , 51mg/kg/day or greater, 52mg/kg/day or greater, 57mg/kg/day or greater, 61mg/kg/day or greater, 66mg/kg/day or greater, 71mg/kg/day day or greater, 76mg/kg/day or greater, 81mg/kg/day or greater, 86mg/kg/day or greater, 91mg/kg/day or greater, 96mg/kg/day or greater, 98mg/kg/day or greater, 99mg/kg/day or greater, 100mg/kg/day or greater, or 101mg/kg/day or greater, and 102mg/kg/day or less, 101mg/kg/day day or less, 100mg/kg/day or less, 99mg/kg/day or less, 98mg/kg/day or less, 90mg/kg/day or less, 85mg/kg/day or less, 80mg/kg/day or more Small, 75mg/kg/day or less, 70mg/kg/day or less, 65mg/kg/day or less, 60mg/kg/day or less, 55mg/kg/day or less, 54mg/kg /day or less, 53mg/kg/day or less, 52mg/kg/day or less, 51mg/kg/day or less, 50mg/kg/day or less, 49mg/kg/day or less , 48mg/kg/day or less, 43mg/kg/day or less, 38mg/kg/day or less, 33mg/kg/day or less, 28mg/kg/day or less, 23mg/kg/day day or less, 18mg/kg/day or less, 15mg/kg/day or less, 13mg/kg/day or less, 12mg/kg/day or less, 11mg/kg/day or less, 10 mg/kg/day or less, 9 mg/kg/day or less, or 8 mg/kg/day or less.

在此態樣中,白蛋白可為卵白蛋白。 In this aspect, the albumin may be ovalbumin.

在根據本揭示內容之一態樣的套組中,說明書可描述在第一投藥之後的1-14天包含白蛋白之組合物及包含人參漿果提取物之組合物的第二投藥。具體而言,第二投藥可在第一投藥之後1天、之後2天、之後3天、之後4天、之後5天、之後6天、之後7天、之後8天、之後9天、之後10天、之後11天、之後12天、之後13天、之後14天或之後15天進行。投藥次數可取決於待治療之標靶而不同。因此,投藥可僅進行一次或三次或三次以上。 In a kit according to an aspect of the present disclosure, the instructions may describe a second administration of the composition comprising albumin and the composition comprising ginseng berry extract 1-14 days after the first administration. Specifically, the second administration may be performed 1 day after, 2 days after, 3 days after, 4 days after, 5 days after, 6 days after, 7 days after, 8 days after, 9 days after, or 10 days after the first administration. 1 day, 11 days after, 12 days after, 13 days after, 14 days after, or 15 days after. The number of doses may vary depending on the target to be treated. Thus, administration may be performed only once or three or more times.

下文中,將經由實例及試驗實例詳細地描述本揭示內容。然而,以下實例及試驗實例僅用於說明目的,且本揭示內容之範疇不受該等實例限制。此外,在 不脫離由隨附申請專利範圍所定義的本揭示內容之範疇的情況下,一般技藝人士可做出各種改變及修改。 Hereinafter, the present disclosure will be described in detail through examples and test examples. However, the following examples and experimental examples are for illustration purposes only, and the scope of the present disclosure is not limited by these examples. In addition, in Various changes and modifications may be made by one of ordinary skill in the art without departing from the scope of the disclosure as defined by the appended claims.

[實例1]人參漿果提取物之製備 [Example 1] Preparation of Ginseng Berry Extract 人參漿果之預處理Pretreatment of Ginseng Berries

在移除種子之後藉由經由日光乾燥或熱風乾燥活人參漿果的漿及外皮來製備乾燥人參漿果。 Dried ginseng berries are prepared by sun-drying or hot-air drying the pulp and outer skin of live ginseng berries after removing the seeds.

活人參漿果提取物之製備Preparation of live ginseng berry extract

藉由自活人參(ginseng)(人參(Panax ginseng C.A.Meyer))之果實移除種子且混合果實之汁、漿及外皮而製備粗人參漿果。藉由添加3L之乙醇在室溫下回流提取4小時,過濾且隨後在45℃下在減壓下濃縮而自1kg之粗人參漿果獲得30g之人參漿果提取物。 Crude ginseng berries are prepared by removing the seeds from the fruit of live ginseng (Panax ginseng C.A. Meyer) and mixing the juice, pulp and rind of the fruit. 30 g of ginseng berry extract was obtained from 1 kg of crude ginseng berries by adding 3 L of ethanol to reflux extraction at room temperature for 4 hours, filtering and then concentrating at 45° C. under reduced pressure.

[比較實例1]人參根提取物之製備 [Comparative Example 1] Preparation of Ginseng Root Extract

以與實例1相同之方式的製備人參根提取物,只不過使用人參的根來替代人參之果實。 A ginseng root extract was prepared in the same manner as in Example 1, except that the root of ginseng was used instead of the fruit of ginseng.

[試驗實例1]成分之比較 [Test Example 1] Comparison of Components 人參漿果及人參根之人參皂苷(人參皂素)成分之分析Analysis of ginsenosides (ginsenosides) in ginseng berries and ginseng roots

在藉由利用醚處理而移除實例1之人參漿果提取物及比較實例1之人參根提取物的油溶性成分之後,利用丁醇(BuOH)提取粗皂素。在濃縮之後,藉由HPLC分析人參皂苷成分。結果展示於第1圖及表1中。 After the oil-soluble components of the ginseng berry extract of Example 1 and the ginseng root extract of Comparative Example 1 were removed by treatment with ether, crude saponin was extracted with butanol (BuOH). After concentration, ginsenoside components were analyzed by HPLC. The results are shown in Figure 1 and Table 1.

Figure 105107576-A0101-12-0029-1
Figure 105107576-A0101-12-0029-1
Figure 105107576-A0101-12-0030-2
Figure 105107576-A0101-12-0030-2

已發現,根據本揭示內容之人參漿果提取物比人參根提取物含有更大數量的總人參皂苷,且詳言之,人參皂苷之組合物為完全不同的。因為根據本揭示內容之人參漿果提取物含有比包括人參皂苷Rb1、Rb2、Rc、Rd等之原人參二醇(protopanaxadiol;PD)人參皂苷更大量的包括人參皂苷Re、Rg1、Rg2等之原人參三醇(protopanaxatriol;PT)人參皂苷,所以可見該人參漿果提取物將展現比人參根顯著優異的效應。 It has been found that the ginseng berry extract according to the present disclosure contains a greater amount of total ginsenosides than the ginseng root extract, and in particular the composition of ginsenosides is quite different. Because the ginseng berry extract according to the present disclosure contains a larger amount of protopanaxadiol (PD) ginsenosides including ginsenosides Re, Rg1, Rg2, etc. than ginsenosides Rb1, Rb2, Rc, Rd, etc. Triol (protopanaxatriol; PT) ginsenoside, so it can be seen that the ginseng berry extract will exhibit a significantly superior effect than ginseng root.

人參漿果及人參根之礦物成分之分析Analysis of Mineral Components in Ginseng Berries and Ginseng Roots

分析實例1之人參漿果提取物及比較實例1之人參根提取物中包括維生素之礦物成分。根據韓國食品標準法典中描述的維生素及礦物分析方法執行分析以展示實例1之人參漿果提取物的作為『果實』的特性不同於人參之根部分。 Mineral components including vitamins in the ginseng berry extract of Example 1 and the ginseng root extract of Comparative Example 1 were analyzed. Analysis was performed according to the vitamin and mineral analysis method described in the Korean Food Standards Code to demonstrate that the properties of the ginseng berry extract of Example 1 as a "fruit" are different from those of the root part of ginseng.

[表2]

Figure 105107576-A0101-12-0031-3
[Table 2]
Figure 105107576-A0101-12-0031-3

已發現,根據本揭示內容之人參漿果提取物含有相較於人參根提取物而言更多的及各種礦物質。因此,預期展現比人參根顯著優異的效應。 It has been found that ginseng berry extract according to the present disclosure contains more and various minerals than ginseng root extract. Therefore, it is expected to exhibit significantly superior effects than ginseng root.

人參漿果提取物中之花青素成分之分析Analysis of Anthocyanins in Ginseng Berry Extract

定量地分析實例1之人參漿果提取物中之花青素成分。 The anthocyanin components in the ginseng berry extract of Example 1 were quantitatively analyzed.

將0.5g之實例1之人參漿果提取物放入琥珀燒瓶中。在添加5mL之1%鹽酸並充分搖動之後,添加10mL之甲醇。隨後,在保持在冷凍機中12小時並過濾之後,進行HPLC分析。使用Mightysil C18(250 x 4.6,5μm)及DIW中之2%甲酸(A)與ACN中之2%甲酸(B)作為移動相,在90% A->80% A,20min->90% A,25min->90% A,30min條件下執行HPLC(Waters)分析。使用520-nm UV分析結果。 0.5 g of the ginseng berry extract of Example 1 was put into an amber flask. After adding 5 mL of 1% hydrochloric acid and shaking well, 10 mL of methanol was added. Subsequently, after being kept in the freezer for 12 hours and filtered, HPLC analysis was performed. Use Mightysil C18 (250 x 4.6, 5μm) and 2% formic acid in DIW (A) and 2% formic acid in ACN (B) as mobile phase, at 90% A->80% A, 20min->90% A , 25min->90% A, 30min under the conditions of performing HPLC (Waters) analysis. Results were analyzed using 520-nm UV.

使用花青素套組(ExtraSynthese,France)(針對氯化錦葵色素之檢測)、花青苷衍生物套 組(ExtraSynthese,France)(針對氯化矢車菊素半乳糖苷及氯化花青素鼠李葡糖苷之檢測)、標準氯化天竺葵素及標準氯化牽牛花素定量地分析人參漿果中之花青素。結果展示於表3中。 Use anthocyanin kit (ExtraSynthese, France) (for detection of chlorinated mallow pigment), anthocyanin derivative kit Group (ExtraSynthese, France) (for the detection of chlorinated cyanidin galactoside and chlorinated anthocyanin rhamnoglucoside), standard chlorinated geranium and standard chlorinated morning glory for the quantitative analysis of anthocyanins in ginseng berries white. The results are shown in Table 3.

Figure 105107576-A0101-12-0032-4
Figure 105107576-A0101-12-0032-4

已發現,根據本揭示內容之人參漿果提取物除人參皂苷之外亦含有高含量之各種花青素。 It has been found that ginseng berry extracts according to the present disclosure also contain high levels of various anthocyanins in addition to ginsenosides.

[試驗實例2]人參漿果提取物對骨髓細胞之增殖的效應 [Test Example 2] Effect of ginseng berry extract on proliferation of bone marrow cells 實驗動物之準備Preparation of Experimental Animals

使自Central Lab Animal購買的重達18-22g之5週大的C57BL/6、OT-1、OT-II TCR及C57BL/6-Lys5.1(CD45.1)雄性小鼠習慣於Pacific Pharmaceuticals動物實驗室環境歷時一週。在該時期期間,將動物收容在頂部設有滅菌過濾器之籠中,且令該等動物自由採食滅菌飼料(正常飲食(D12450B,Research Diets,New Brunswick,NJ,USA)及水。將實驗室環境維持在20±2℃及50±10%濕度下,並利用12小時亮/暗循環。根據IACUC14-014飼養動物。 5-week-old C57BL/6, OT-1, OT-II TCR and C57BL/6-Lys5.1 (CD45.1) male mice weighing 18-22 g purchased from Central Lab Animal were habituated to Pacific Pharmaceuticals animals The lab environment lasted a week. During this period, the animals were housed in cages with sterile filter tops and were given ad libitum access to sterilized feed (normal diet (D12450B, Research Diets, New Brunswick, NJ, USA) and water. The experimental The chamber environment was maintained at 20±2°C and 50±10% humidity with a 12-hour light/dark cycle. Animals were maintained according to IACUC14-014.

骨髓細胞之增殖Proliferation of bone marrow cells

在藉由頸椎脫臼法犧牲小鼠之後,在含有10%牛血清之RPMI 1640培養基中培養骨髓細胞(骨髓有核細胞)至70%長滿。在添加50ng/mL GM-CSF及IL-4並培養6天之後,利用人參根提取物(ginseng root extract;GR)或人參漿果提取物(ginseng berry extract;GB)以50μg/mL之濃度處理細胞24小時。對於FACS分析而言,將0.5-1百萬個細胞再懸浮於FACS緩衝液(2% FBS於PBS中),且使Fc受體阻斷30分鐘。在添加可辨識CD86及MHC II類之經螢光標記抗體之後,在4℃下進行孵化30分鐘。隨後,在利用FACS緩衝液洗滌之後,藉由使用FlowJo(9.7.6版)之流式細胞術(BD FACS LSR)進行分析(第1圖)。 After sacrificing mice by cervical dislocation, bone marrow cells (bone marrow nucleated cells) were cultured to 70% confluence in RPMI 1640 medium containing 10% bovine serum. After adding 50 ng/mL GM-CSF and IL-4 and culturing for 6 days, the cells were treated with ginseng root extract (GR) or ginseng berry extract (ginseng berry extract; GB) at a concentration of 50 μg/mL 24 hours. For FACS analysis, 0.5-1 million cells were resuspended in FACS buffer (2% FBS in PBS), and Fc receptors were blocked for 30 minutes. After adding fluorescently labeled antibodies that recognize CD86 and MHC class II, incubation was performed at 4°C for 30 minutes. Subsequently, after washing with FACS buffer, analysis was performed by flow cytometry (BD FACS LSR) using FlowJo (version 9.7.6) (Fig. 1).

[試驗實例3]人參漿果提取物對脾樹狀細胞之活化的效應 [Test Example 3] Effect of ginseng berry extract on activation of spleen dendritic cells

在向試驗實例2之實驗動物靜脈內注射10mg/kg或50mg/kg之人參漿果提取物之後,在24小時之後藉由頸椎脫臼法犧牲動物。在移除脾並添加含有2%牛血清之膠原酶之後,在室溫下進行孵化20分鐘。在藉由使分離細胞離心來獲得團塊並在添加Histopaque 1077(Sigma-Aldrich)之後使該等團塊溶解之後,藉由在1700g下再次離心來獲得團塊。在添加可辨識CD11c+之經螢光標記抗體並孵化30分鐘,繼之以利用FACS緩衝液洗滌之後,藉由使用FlowJo(9.7.6版)之流式細胞 術(BD FACS LSR)進行分析。已發現,人參漿果提取物可以濃度依賴性方式促進脾樹狀細胞之增殖(第2圖)。 After intravenous injection of 10 mg/kg or 50 mg/kg of the ginseng berry extract to the experimental animals of Test Example 2, the animals were sacrificed by cervical dislocation 24 hours later. After removing the spleen and adding collagenase containing 2% bovine serum, incubation was performed at room temperature for 20 minutes. After obtaining pellets by centrifugation of isolated cells and lysing the pellets after addition of Histopaque 1077 (Sigma-Aldrich), pellets were obtained by centrifugation again at 1700 g. Analysis was performed by flow cytometry (BD FACS LSR) using FlowJo (version 9.7.6) after addition of a fluorescently labeled antibody recognizing CD11c + and incubation for 30 minutes, followed by washing with FACS buffer. It was found that ginseng berry extract can promote the proliferation of splenic dendritic cells in a concentration-dependent manner (Fig. 2).

[試驗實例4]人參漿果提取物對輔助T細胞及殺手T細胞之活化的效應 [Test Example 4] Effect of Ginseng Berry Extract on Activation of Helper T Cells and Killer T Cells

在以3天間隔向試驗實例2之實驗動物靜脈內注射50mg/kg之人參漿果提取物兩次之後,在第二注射之後3天藉由頸椎脫臼法犧牲動物。在取出並稱重脾之後,藉由利用混合器研磨而製備單細胞懸浮液。在利用細胞濾器過濾單細胞並使用RBC溶解緩衝液或高滲壓溶液移除RBC之後,使用細胞濾器完全移除溶解產物以供FACS分析。藉由以錐蟲藍染色來計數活脾細胞之總數。對於FACS分析而言,將0.5-1百萬個細胞再懸浮於FACS緩衝液(2% FBS於PBS中),且使Fc受體阻斷30分鐘。在添加可辨識CD4、CD8、IFN-及TNF-之經螢光標記抗體之後,在4℃下進行孵化30分鐘。隨後,在利用FACS緩衝液洗滌之後,藉由使用FlowJo(9.7.6版)之流式細胞術(BD FACS LSR)進行分析。結果展示於第3圖中。 After intravenously injecting 50 mg/kg of the ginseng berry extract to the experimental animals of Test Example 2 twice at 3-day intervals, the animals were sacrificed by cervical dislocation 3 days after the second injection. After removing and weighing the spleen, a single cell suspension was prepared by triturating with a mixer. After filtering single cells with a cell strainer and removing RBCs using RBC lysis buffer or hypertonic solution, the lysate was completely removed using a cell strainer for FACS analysis. The total number of viable splenocytes was counted by staining with trypan blue. For FACS analysis, 0.5-1 million cells were resuspended in FACS buffer (2% FBS in PBS), and Fc receptors were blocked for 30 minutes. After addition of fluorescently labeled antibodies recognizing CD4, CD8 , IFN- and TNF- , incubation was performed at 4°C for 30 minutes. Subsequently, after washing with FACS buffer, analysis was performed by flow cytometry (BD FACS LSR) using FlowJo (version 9.7.6). The results are shown in Figure 3.

[試驗實例5]人參漿果提取物對樹狀細胞之抗原呈現能力的提高的效應 [Test Example 5] Effect of Ginseng Berry Extract on Improving Antigen Presentation Ability of Dendritic Cells

在向試驗實例2之實驗動物靜脈內注射PBS、單獨的0.05mg/kg之卵白蛋白(ovalbumin;OVA)或0.05mg/kg之卵白蛋白及50mg/kg之人參漿果提取物(ovalbumin and ginseng berry extract;OVA+GB)之後,藉由頸椎脫臼法犧牲動物。在移除脾並添加含有2%牛血清之膠原酶之後,在室溫下進行孵化20分鐘。在藉由使分離細胞離心來獲得團塊並在添加Histopaque 1077(Sigma-Aldrich)之後使該等團塊溶解之後,藉由在1700g下再次離心來獲得團塊。在添加可辨識CD11c+、MHC I及MHC II之經螢光標記抗體並孵化30分鐘,繼之以利用FACS緩衝液洗滌之後,藉由使用FlowJo(9.7.6版)之流式細胞術(BD FACS LSR)進行分析。已發現,共同投與人參漿果提取物及卵白蛋白之群組展示比僅投與卵白蛋白之群組提高的樹狀細胞之抗原呈現能力(第4圖)。 After intravenously injecting PBS, ovalbumin (ovalbumin; OVA) alone or 0.05 mg/kg ovalbumin and 50 mg/kg ginseng berry extract (ovalbumin and ginseng berry extract) to the experimental animals of Test Example 2 ; OVA+GB), animals were sacrificed by cervical dislocation. After removing the spleen and adding collagenase containing 2% bovine serum, incubation was performed at room temperature for 20 minutes. After obtaining pellets by centrifugation of isolated cells and lysing the pellets after addition of Histopaque 1077 (Sigma-Aldrich), pellets were obtained by centrifugation again at 1700 g. After adding fluorescently labeled antibodies that can recognize CD11c + , MHC I and MHC II and incubating for 30 minutes, followed by washing with FACS buffer, by flow cytometry using FlowJo (version 9.7.6) (BD FACS LSR) for analysis. It was found that the group co-administered with ginseng berry extract and ovalbumin exhibited increased antigen presentation ability of dendritic cells than the group administered with ovalbumin alone ( FIG. 4 ).

[試驗實例6]人參漿果提取物對抗原特異T細胞之增殖的促進的效應 [Test Example 6] Effect of ginseng berry extract on promotion of proliferation of antigen-specific T cells

自試驗實例2之實驗動物中的OT-I小鼠分離CD8 T細胞,且自OT-II小鼠分離CD4 T細胞。藉由溶於含有10gM之CFSE的PBS(Invitrogen)來染色細胞。在將細胞植入CD45.1小鼠中且隨後靜脈內注射PBS、單獨的0.05mg/kg之卵白蛋白(ovalbumin;OVA)或0.05mg/kg之卵白蛋白及50mg/kg之人參漿果提取物(ovalbumin and ginseng berry extract;OVA+GB)之後,在3天之後藉由頸椎脫臼法犧牲動物。在移除脾並添加含有2%牛血清之膠原酶之後,在室溫下進行孵化20分鐘。在藉由使分離細胞離心來獲得團塊並在添加Histopaque 1077 (Sigma-Aldrich)之後使該等團塊溶解之後,藉由在1700g下再次離心來獲得團塊。在添加可辨識CD45.2、OT-I及OT-II之經螢光標記抗體並孵化30分鐘,繼之以利用FACS緩衝液洗滌之後,藉由使用FlowJo(9.7.6版)之流式細胞術(BD FACS LSR)進行分析。已發現,共同投與人參漿果提取物及卵白蛋白之群組展示比僅投與卵白蛋白之群組獲促進的抗原特異T細胞之增殖(第5圖)。 Among the experimental animals of Test Example 2, CD8 T cells were isolated from OT-I mice, and CD4 T cells were isolated from OT-II mice. Cells were stained by dissolving in PBS (Invitrogen) containing 10 gM CFSE. After implanting cells into CD45.1 mice and then intravenously injecting PBS, 0.05 mg/kg of ovalbumin (OVA) alone or 0.05 mg/kg of ovalbumin and 50 mg/kg of ginseng berry extract ( ovalbumin and ginseng berry extract; OVA+GB), animals were sacrificed 3 days later by cervical dislocation. Incubation was performed at room temperature for 20 minutes after removal of the spleen and addition of collagenase containing 2% bovine serum. After pelleting by centrifugation of isolated cells and addition of Histopaque 1077 (Sigma-Aldrich) after lysing the pellets, the pellets were obtained by centrifugation again at 1700 g. After adding fluorescently labeled antibodies that can recognize CD45.2, OT-I and OT-II and incubating for 30 minutes, followed by washing with FACS buffer, by using FlowJo (version 9.7.6) flow cytometry analysis by BD FACS LSR. It was found that the co-administered group of ginseng berry extract and ovalbumin exhibited enhanced proliferation of antigen-specific T cells compared to the group administered only ovalbumin (Fig. 5).

[試驗實例7]人參漿果提取物對腫瘤之抑制的效應 [Test Example 7] Inhibitory effect of ginseng berry extract on tumor

將1x106黑素瘤癌細胞注射至試驗實例2之C57BL/6小鼠。在等待7天直至癌細胞沉降並以5天間隔兩次靜脈內注射PBS、單獨的0.05mg/kg之卵白蛋白(ovalbumin;OVA)或0.05mg/kg之卵白蛋白及50mg/kg之人參漿果提取物(ovalbumin and ginseng berry extract;OVA+GB)之後,分析腫瘤體積。已發現,共同投與人參漿果提取物及卵白蛋白之群組可相較於僅投與卵白蛋白之群組而言顯著地抑制腫瘤之增殖(第6圖)。 1×10 6 melanoma cancer cells were injected into the C57BL/6 mice of Test Example 2. After waiting 7 days until the cancer cells settled and injecting intravenously twice at 5-day intervals PBS, 0.05 mg/kg ovalbumin (OVA) alone or 0.05 mg/kg ovalbumin and 50 mg/kg ginseng berry extract Tumor volume was analyzed after ovalbumin and ginseng berry extract; OVA+GB. It was found that the group co-administered with ginseng berry extract and ovalbumin significantly inhibited the proliferation of tumors compared to the group administered only ovalbumin (Figure 6).

下文中,將經由調配物實例詳細地描述本揭示內容。然而,以下調配物實例僅用於說明目的,且本揭示內容之範疇不受該等實例限制。 Hereinafter, the present disclosure will be described in detail via formulation examples. However, the following formulation examples are for illustration purposes only, and the scope of the present disclosure is not limited by these examples.

[調配物實例1]丸劑之製備 [Formulation Example 1] Preparation of Pills

在將30wt%的實例1中製備的人參漿果提取物、0.03wt%的卵白蛋白、30wt%的玉米澱粉、 20wt%的甘油及20wt%的山梨糖醇粉末混合之後,使用制丸機製備丸劑。丸劑之最終重量為3.5g。 The ginseng berry extract prepared in the example 1 of 30wt%, the ovalbumin of 0.03wt%, the cornstarch of 30wt%, After the glycerin of 20wt% and the sorbitol powder of 20wt% are mixed, use pill machine to prepare pill. The final weight of the pellets was 3.5 g.

[調配物實例2]錠劑之製備 [Formulation Example 2] Preparation of Tablets

在將30wt%的實例1中製備的人參漿果提取物、0.03wt%的卵白蛋白、20.5wt%的乳糖、20wt%的糊精、20wt%的麥芽糖醇粉末及7wt%的木糖醇粉末混合且使用流化床乾燥機造粒之後,添加2.5wt%的糖酯且使用制錠機製備錠劑。錠劑之最終重量為2g。 The ginseng berry extract prepared in the example 1 of 30wt%, the ovalbumin of 0.03wt%, the lactose of 20.5wt%, the dextrin of 20wt%, the maltitol powder of 20wt% and the xylitol powder of 7wt% were mixed and After granulation using a fluidized bed dryer, 2.5 wt% of sugar ester was added and lozenges were prepared using a tablet machine. The final weight of the lozenges is 2 g.

[調配物實例3]顆粒之製備 [Formulation Example 3] Preparation of Granules

在將30wt%的實例1中製備的人參漿果提取物、0.03wt%的卵白蛋白、5wt%的木糖醇及65wt%的異麥芽糖醇混合且使用流化床造粒機造粒之後,將所製備顆粒填充於囊袋中。顆粒之最終重量為2g。 After mixing 30 wt% of the ginseng berry extract prepared in Example 1, 0.03 wt% of ovalbumin, 5 wt% of xylitol, and 65 wt% of isomalt and granulated using a fluidized bed granulator, the resulting The prepared granules are filled in sachets. The final weight of the granules was 2 g.

[調配物實例4]注射劑之製備 [Formulation Example 4] Preparation of Injection

根據常見方法利用表4中描述的組合物來製備注射劑。 Injections were prepared using the compositions described in Table 4 according to common methods.

Figure 105107576-A0101-12-0037-5
Figure 105107576-A0101-12-0037-5

[調配物實例5]健康食品之製備 [Preparation Example 5] Preparation of Healthy Food

根據常見方法利用表5中描述的組合物來製備健康食品。 Health food was prepared using the compositions described in Table 5 according to common methods.

Figure 105107576-A0101-12-0038-6
Figure 105107576-A0101-12-0038-6

Claims (15)

一種人參漿果提取物及卵白蛋白在製造用於癌症免疫療法之組合物之用途,其中該癌症為惡性黑素瘤,其中該人參漿果提取物為藉由以下方式獲得之提取物:以C1-C6醇回流提取人參漿果並在減壓下濃縮,其中以該人參漿果提取物之總重量計,該人參漿果提取物包含0.1至10wt%之以下一或多者:人參皂苷Rb1、人參皂苷Rb2、人參皂苷Rb3、人參皂苷Rc、人參皂苷Rd、人參皂苷Rg1及人參皂苷Rg2,其中該人參漿果提取物具有之原人參二醇(protopanaxadiol;PD)人參皂苷與原人參三醇(protopanaxatriol;PT)人參皂苷之一比率,PD/PT,為0.50至2.5,其中該人參漿果提取物之濃度為1至100μg/mL,其中卵白蛋白之濃度為0.001至0.1μg/mL,且其中該組合物促進骨髓細胞之增殖及T細胞之活化,並活化樹狀細胞。 A use of ginseng berry extract and ovalbumin in the manufacture of a composition for cancer immunotherapy, wherein the cancer is malignant melanoma, wherein the ginseng berry extract is an extract obtained by: using C 1 - C6 alcohol reflux extracts ginseng berry and concentrates under reduced pressure, wherein based on the total weight of the ginseng berry extract, the ginseng berry extract contains 0.1 to 10wt% of the following one or more: ginsenoside Rb1, ginsenoside Rb2 , ginsenoside Rb3, ginsenoside Rc, ginsenoside Rd, ginsenoside Rg1 and ginsenoside Rg2, wherein the ginseng berry extract has protopanaxadiol (protopanaxadiol; PD) ginsenoside and protopanaxatriol (protopanaxatriol; PT) The ratio of ginsenosides, PD/PT, is 0.50 to 2.5, wherein the concentration of the ginseng berry extract is 1 to 100 μg/mL, and wherein the concentration of ovalbumin is 0.001 to 0.1 μg/mL, and wherein the composition promotes bone marrow Proliferation of cells, activation of T cells, and activation of dendritic cells. 如請求項1所述之用途,其中以該組合物之總重量計,該組合物包含0.001至80.0wt%之該人參漿果提取物。 The use according to claim 1, wherein the composition comprises 0.001 to 80.0wt% of the ginseng berry extract based on the total weight of the composition. 如請求項1所述之用途,其中以該人參漿果提取物之總重量計,該人參漿果提取物包含8.0至30.0wt%之人參皂苷Re。 The use as described in Claim 1, wherein the ginseng berry extract contains 8.0 to 30.0 wt% of ginsenoside Re based on the total weight of the ginseng berry extract. 如請求項1所述之用途,其中以該人參漿果提取物之總重量計,該人參漿果提取物包含23至80wt%之總人參皂苷。 The use as described in Claim 1, wherein based on the total weight of the ginseng berry extract, the ginseng berry extract comprises 23 to 80 wt% of total ginsenosides. 如請求項1所述之用途,其中該人參漿果提取物進一步包含維生素、礦物質及花青素。 The use as described in claim 1, wherein the ginseng berry extract further contains vitamins, minerals and anthocyanins. 如請求項5所述之用途,其中以該人參漿果提取物之總重量計,該礦物質包含以下一或多者:4000mg/100g或更多之鉀、600mg/100g或更多之鈣、40mg/100g或更多之鐵、150mg/100g或更多之磷、250mg/100g或更多之鎂及140mg/100g或更多之鋅。 The use as described in claim 5, wherein based on the total weight of the ginseng berry extract, the minerals include one or more of the following: 4000mg/100g or more of potassium, 600mg/100g or more of calcium, 40mg Iron per 100g or more, phosphorus at 150mg/100g or more, magnesium at 250mg/100g or more, and zinc at 140mg/100g or more. 如請求項5所述之用途,其中以該人參漿果提取物之總重量計,該維生素包含以下一或多者:150μg/100g或更多之維生素A、8mg/100g或更多之維生素B1、5mg/100g或更多之維生素B2、8mg/100g或更多之維生素B6、3mg/100g或更多之維生素C、180μg/100g或更多之維生素K、3.5mg/100g或更多之菸酸、4mg/100g或更多之泛酸及250μg/100g或更多之葉酸。 The use as described in claim 5, wherein based on the total weight of the ginseng berry extract, the vitamin comprises one or more of the following: 150 μg/100g or more of vitamin A, 8 mg/100g or more of vitamin B1 , 5mg/100g or more vitamin B 2 , 8mg/100g or more vitamin B 6 , 3mg/100g or more vitamin C, 180μg/100g or more vitamin K, 3.5mg/100g or more niacin, 4mg/100g or more pantothenic acid and 250μg/100g or more folic acid. 如請求項5所述之用途,其中以該人參漿果提取物之總重量計,該花青素之濃度為20ppm(w/w)或更高。 The use as described in claim 5, wherein the concentration of the anthocyanins is 20 ppm (w/w) or higher based on the total weight of the ginseng berry extract. 如請求項5所述之用途,其中該花青素包含選自由氯化錦葵色素(malvidin chloride)、氯化矢車菊素半乳糖苷(ideain chloride)、氯化天竺葵素(pelargonidin chloride)及氯化花青素鼠李葡糖苷(keracyanin chloride)組成之群組中之一或多種。 The use as described in claim 5, wherein the anthocyanin comprises a compound selected from the group consisting of malvidin chloride, ideain chloride, pelargonidin chloride and chloride One or more of the group consisting of keracyanin chloride. 如請求項9所述之用途,其中該人參漿果提取物包含:以該人參漿果提取物之總重量計,8.0至16.0ppm(w/w)之氯化錦葵色素;以該人參漿果提取物之總重量計,1.0至5.0ppm(w/w)之氯化矢車菊素半乳糖苷;以該人參漿果提取物之總重量計,6.0至12.0ppm(w/w)之氯化天竺葵素;及以該人參漿果提取物之總重量計,2.0至6.0ppm(w/w)之氯化花青素鼠李葡糖苷。 The use as described in claim 9, wherein the ginseng berry extract comprises: based on the total weight of the ginseng berry extract, 8.0 to 16.0ppm (w/w) of chlorinated mallow pigment; Based on the total weight of the ginseng berry extract, 1.0 to 5.0 ppm (w/w) of chlorinated cyanidin galactoside; based on the total weight of the ginseng berry extract, 6.0 to 12.0 ppm (w/w) of chlorinated geranium; and Based on the total weight of the ginseng berry extract, 2.0 to 6.0 ppm (w/w) of chlorinated anthocyanidin rhamnoside. 如請求項1所述之用途,其中以100重量份之該人參漿果提取物計,該組合物包含0.01至1重量份之卵白蛋白。 The use according to claim 1, wherein based on 100 parts by weight of the ginseng berry extract, the composition comprises 0.01 to 1 part by weight of ovalbumin. 如請求項1所述之用途,其中該組合物為一醫藥組合物。 The use as described in claim 1, wherein the composition is a pharmaceutical composition. 如請求項1所述之用途,其中該組合物為一健康食品組合物。 The use as described in Claim 1, wherein the composition is a health food composition. 一種癌症免疫療法套組,其包含:一組合物,其包含卵白蛋白;一組合物,其包含一人參漿果提取物;及一說明書,其中該癌症為惡性黑素瘤,其中該人參漿果提取物為藉由以下方式獲得之提取物:以C1-C6醇回流提取人參漿果並在減壓下濃縮,其中以該人參漿果提取物之總重量計,該人參漿果提取物包含0.1至10wt%之以下一或多者:人參皂苷Rb1、人參皂苷Rb2、人參皂苷Rb3、人參皂苷Rc、人參皂苷Rd、人參皂苷Rg1及人參皂苷Rg2,其中該人參漿果提取物具有之原人參二醇(protopanaxadiol;PD)人參皂苷與原人參三醇(protopanaxatriol;PT)人參皂苷之一比率,PD/PT,為0.50至2.5,其中該人參漿果提取物之濃度為1至100μg/mL, 其中卵白蛋白脂濃度為0.001至0.1μg/mL,其中包含卵白蛋白之該組合物之投藥劑量為0.001至0.1mg/kg/日,且包含人參漿果提取物之該組合物之投藥劑量為1至100mg/kg/日,其中包含人參漿果提取物之該組合物促進骨髓細胞之增殖及T細胞之活化,並活化樹狀細胞,且其中該說明書描述包含卵白蛋白之該組合物及包含人參漿果提取物之該組合物之同時投藥。 A cancer immunotherapy kit comprising: a composition comprising ovalbumin; a composition comprising a ginseng berry extract; and an instruction sheet, wherein the cancer is malignant melanoma, wherein the ginseng berry extract is an extract obtained by reflux extracting ginseng berries with C 1 -C 6 alcohol and concentrating under reduced pressure, wherein the ginseng berry extract contains 0.1 to 10 wt% based on the total weight of the ginseng berry extract One or more of the following: ginsenoside Rb1, ginsenoside Rb2, ginsenoside Rb3, ginsenoside Rc, ginsenoside Rd, ginsenoside Rg1 and ginsenoside Rg2, wherein the ginseng berry extract contains protopanaxadiol; A ratio of PD) ginsenosides to protopanaxatriol (protopanaxatriol; PT) ginsenosides, PD/PT, is 0.50 to 2.5, wherein the concentration of the ginseng berry extract is 1 to 100 μg/mL, wherein the concentration of ovalbumin is 0.001 to 0.1 μg/mL, wherein the dosage of the composition comprising ovalbumin is 0.001 to 0.1 mg/kg/day, and the dosage of the composition comprising ginseng berry extract is 1 to 100 mg/kg/day, wherein the composition comprising ginseng berry extract promotes proliferation of bone marrow cells and activation of T cells, and activates dendritic cells, and wherein the specification describes the composition comprising ovalbumin and the composition comprising ginseng berry extract Dosing at the same time. 如請求項14所述之套組,其中該說明書描述在第一次投藥之後的1至14天包含卵白蛋白之該組合物及包含人參漿果提取物之該組合物的第二次投藥。 The kit according to claim 14, wherein the instructions describe a second administration of the composition comprising ovalbumin and the composition comprising ginseng berry extract 1 to 14 days after the first administration.
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