M364520 五、新型說明： 【新型所屬之技術領域】 本創作是有關於一種製劑結構，且特別是有關於一種 . 免疫調節製劑結構。 _ 【先前技術】 食藥用真菌的營養及醫療價值自古即有記載，在現今 保健食品中，食藥用真菌亦佔了相當的比例，多以子囊菌 ❿ 綱及單子菌綱之真菌為主，如：牛棒芝、冬蟲夏草、靈芝、 蛹蟲草、雲芝、裂褶菌等，且日益受到各界的重視。根據 相關研究發現其含有多種生理活性成份，例如：三萜類化 合物、超氧歧化酵素、腺甘、多酷體(如：β-D-葡聚醣）、蛋 白質（含免疫蛋白）、維生素（如：維生素B、煙鹼酸、麥角 固醇）、微量元素（如：鈣、磷、鍺）、核酸、凝集素、氨基 酸、固醇類、木質素、血壓穩定物質等。生理活性功能包 ® 括有：抗腫瘤、增加免疫能力、抗病毒、抗過敏、抗高血 壓、抑制血小板凝集、降血糖、降膽固醇、抗細菌、保護 肝臟等。 _ 除了食藥用真菌之外，對於免疫調節最常見的則是益 生菌。因為新生兒出生時，免疫系統具有Th2免疫的傾向。 從臨床調查中發現，缺乏腸球菌的嬰兒容易過敏，嬰兒腸 道菌相與過敏性疾病的發生率有相關性。根據這些觀察， 3 M364520 補充特定益生菌種能改善腸中菌相，促使免疫系統產生 Thl免疫的傾向，能夠阻斷過敏性疾病的病理機轉，進而 改善臨床症狀。而隨機雙盲對照臨床試驗也證實，補充特 足儀後，tL 括 Latobacillus casei、Lactobacillus, paracasei、M364520 V. New description: [New technical field] This creation is about a preparation structure, and especially related to one. Immunomodulation preparation structure. _ 【Prior Art】 The nutritional and medical value of medicinal and medicinal fungi has been recorded since ancient times. In today's health foods, medicinal and medicinal fungi also account for a considerable proportion, mostly with fungi of the genus Ascomycetes and Monosporaceae. Such as: Niuzhizhi, Cordyceps sinensis, Ganoderma lucidum, Cordyceps militaris, Yunzhi, Schizophyllum, etc., and has received increasing attention from all walks of life. According to relevant research, it contains a variety of physiologically active ingredients, such as: triterpenoids, superoxide dismutase, adenosine, multi-cool (such as: β-D-glucan), protein (including immune protein), vitamins ( Such as: vitamin B, niacin, ergosterol, trace elements (such as: calcium, phosphorus, strontium), nucleic acids, lectins, amino acids, sterols, lignin, blood pressure stable substances. The physiologically active functional package includes: anti-tumor, increased immunity, anti-viral, anti-allergic, anti-hypertension, inhibition of platelet aggregation, blood sugar lowering, cholesterol lowering, anti-bacterial, and protection of the liver. In addition to medicinal fungi, the most common for immune regulation is probiotics. Because the newborn is born, the immune system has a tendency to be immune to Th2. It has been found from clinical investigation that infants lacking enterococci are susceptible to allergies, and infant intestinal flora is associated with the incidence of allergic diseases. Based on these observations, 3 M364520 supplementation with specific probiotic strains can improve the intestinal flora, promote the immune system to produce Thl immunity, and block the pathogenesis of allergic diseases, thereby improving clinical symptoms. Randomized double-blind controlled clinical trials have also confirmed that after supplementing the special instrument, tL includes Latobacillus casei, Lactobacillus, paracasei,
Lactobacil丨us. rhamnosus GG，能夠有致藏少過敗也疾病的 嚴重度與發生頻率。而它主要的機轉，則是透過腸道黏膜 樹突細胞的作用，刺激調節型T細胞的增生活化，而抑制 • Th2的免疫反應。臨床試驗也發現口服熱殺死的 就有缓解過敏性疾病的效果，因為 其有效成分是組成益生菌細胞壁的胜肽多醣體。 胜肽多醣體能夠被樹突細胞上的Toll-like 2接受器辨 識，進而刺激先天性免疫反應的活化，包括活化樹突細胞 與巨嗟細胞，它會促使這些免疫細胞分泌INF-γ以及IL-12 等細胞激素，強化Thl免疫反應的進行，而抑制Th2免疫 • 反應的發展’因此能降低過敏發炎反應。除了乳酸菌的胜 肽多醣體對於免疫反應具有調節作用之外，許多研究也證 明β-glucan也是很好的免疫調節劑（immunomodulator)，尤 其在癌症的辅療上具有一定的效果。也有雙盲臨床試驗得 研究結果指出它對過敏免疫反應也具有調節作用，在口服 β-ghican 12週後過敏性鼻炎患者的鼻腔沖洗液中几_4, IL-5 這類Th2的細胞激素比對照組明顯下降，而屬於Thl的細 胞激素IL-12明顯上升。同時’鼻腔沖洗液中的嗜伊紅性 4 M364520 乳糖、擰檬酸、蔗糖、甘露醇、山梨醇及乳糖醇所組成之 群組。 免疫調節粉層20黏附於載體10外，也就是說，載體 10的外層為免疫調節粉層20，其中，免疫調節粉層20為 充分均勻黏附於載體10外。 簡單來說，免疫調節粉層為一免疫增進劑或一免疫抑 ' 制劑，並透過一萃取步驟或一乾燥步驟或兩者所製成。萃 • 取步驟主要用以提高免疫調節粉層20之活性。而乾燥步驟 為一冷凍乾燥步驟或一喷霧乾燥步驟。 其中所述的萃取步驟可利用免疫調節主成分在溶劑中 不同溶解度進行萃取活性成分，其方法有水萃取、醇類萃 取、其他溶劑萃取。其中，水萃取所使用的水應經過去離 子化或軟化水或加熱純水進行。醇類萃取較常見以甲醇及 乙醇進行萃取，本實施例中則以不同濃度乙醇進行萃取， I 其最適濃度為40%〜100%。其他溶劑萃取可以鹽酸、醋酸、 檸檬酸、酸性海藻多醣、磷酸氫二鉀、氫氧化鈉等溶劑進 行萃取。 免疫調節粉層20可為任何具有免疫調節能力之化合 - 物、蛋白質、多醣、食藥用真菌、益生菌或藥物。此外， - 免疫調節粉層20亦可為任一具免疫調節能力之化合物、具 有免疫調節功能性之蛋白質萃取物、高分子多醣體、益生 菌包含乳酸菌屬、雙歧桿菌屬、芽孢菌屬、枯草桿菌、酵 8 M364520 =等及食藥用真菌以子㈣綱及單子菌綱為主，包含牛 直一絲：夏草1之、蛹蟲草、雲芝、裂褶菌等食藥用 ^园固4肢或子實體，且利用萃取步驟提高免疫調節粉層 之活性成分亚以壤乾或噴霧乾燥製成之粉層。 包覆層30，包覆於免疫調節粉層2〇外。也就是說， 為在成型的免疫調節粉層2G上包覆_包覆層％。 包覆層可為糖衣、釋放性包衣、膜衣，此外，包覆層 亦可添加自^^加劑’其目的為增加該免疫調節製劑之 吸收=乍用、或美觀及調味或修倚口感。 广 兄’上述的免疫調節製劑結構1為-種含有免 疫㈣成份的球體結構，為一緩釋劑型。 録：亡：述’本創作的免疫調節製劑結構，其可專-的 此，服用L的增加或減少免疫反應’且增加吸收效率。如 身體保健能Γ用過後，其可以調節生物體免疫系統’增強 二本露如上’然其並非用以限 和範圍内，所作更動愈 在不脫離本創作之精神 利保護範_。…_之料替換，㈣本創作之專 【圖式簡單說明】 圖1疋本創作—會;^ v, 圖。 e例之免疫調節製劑結構的結構剖面 M364520 【主要元件符號說明】 1 免疫調節製劑結構 10 載體 20 免疫調節粉層 包覆層 30Lactobacil丨us. rhamnosus GG, can have less seriousness and frequency of disease. Its main mechanism of action is to stimulate the proliferation and activation of regulatory T cells through the action of intestinal mucosal dendritic cells, while inhibiting the immune response of Th2. Clinical trials have also found that oral hot killing has the effect of alleviating allergic diseases because its active ingredient is the peptide polysaccharide that makes up the probiotic cell wall. The peptide polysaccharide can be recognized by the Toll-like 2 receptor on dendritic cells, thereby stimulating the activation of the innate immune response, including activation of dendritic cells and giant scorpion cells, which promotes the secretion of INF-γ and IL by these immune cells. -12 and other cytokines, strengthen the ThH immune response, and inhibit the development of Th2 immune response - thus reducing allergic inflammatory response. In addition to the regulation of the immune response by lactic acid bacteria, many studies have also shown that β-glucan is also a good immunomodulator, especially in the adjuvant treatment of cancer. There are also double-blind clinical trials that have shown that it also has a regulatory effect on allergic immune responses. The cytokine ratio of Th2 in the nasal lavage fluid of patients with allergic rhinitis after oral administration of β-ghican for 12 weeks. The control group decreased significantly, while the IL-1, a cytokine belonging to Th1, increased significantly. At the same time, the eosinophilic 4 M364520 lactose, citric acid, sucrose, mannitol, sorbitol and lactitol in the nasal rinse. The immunomodulating powder layer 20 is adhered to the outside of the carrier 10, that is, the outer layer of the carrier 10 is the immunoregulating powder layer 20, wherein the immunoregulating powder layer 20 is sufficiently uniformly adhered to the carrier 10. Briefly, the immunomodulatory powder layer is an immunopotentiator or an immunosuppressive formulation and is prepared by an extraction step or a drying step or both. The extraction step is mainly used to increase the activity of the immunomodulatory powder layer 20. The drying step is a freeze drying step or a spray drying step. The extraction step described above utilizes the immunomodulating main component to extract the active ingredient in different solubility in a solvent by water extraction, alcohol extraction, and other solvent extraction. Among them, the water used for water extraction should be subjected to deionization or demineralization or heating of pure water. The alcohol extraction is more commonly extracted with methanol and ethanol. In this example, the extraction is carried out with different concentrations of ethanol, and the optimum concentration of I is 40%~100%. Other solvent extractions may be carried out by using a solvent such as hydrochloric acid, acetic acid, citric acid, acid seaweed polysaccharide, dipotassium hydrogen phosphate or sodium hydroxide. The immunomodulatory powder layer 20 can be any compound having immunomodulatory ability, protein, polysaccharide, medicinal fungi, probiotic or drug. In addition, the immunomodulatory powder layer 20 may also be any compound having immunomodulatory ability, a protein extract having immunomodulatory function, a high molecular polysaccharide, a probiotic containing a lactic acid bacterium, a Bifidobacterium, a genus, a spore genus, Bacillus subtilis, leaven 8 M364520 = and medicinal and medicinal fungi mainly consisting of the genus (four) and monospores, including bovine straight one: summer grass 1, locust grass, Yunzhi, schizophyllum and other food and medicinal herbs 4 limbs or fruiting bodies, and the extraction step is used to increase the active ingredient of the immunomodulating powder layer to a powder layer made by dry or spray drying. The coating layer 30 is coated on the outside of the immunoregulating powder layer. That is, the % of the coating layer was coated on the molded immunoregulating powder layer 2G. The coating layer may be a sugar coating, a release coating or a film coating. In addition, the coating layer may also be added with an additive to increase the absorption of the immunomodulating preparation, or to be aesthetically pleasing and seasoning or repairing. Taste. Guangxi' The immunomodulatory preparation structure 1 described above is a spheroidal structure containing an immunological (four) component and is a sustained release dosage form. Record: Death: The structure of the immunomodulatory preparation of the present invention, which can be used exclusively, increases or decreases the immune response by taking L and increases the absorption efficiency. If the body health care can be used, it can regulate the immune system of the organism. 'Enhanced the two dews as above'. However, it is not limited to the scope and scope, and the changes are not deviated from the spirit of this creation. ... _ material replacement, (four) the purpose of this creation [simple description of the diagram] Figure 1 疋 创作 creation - meeting; ^ v, Figure. Structural section of the structure of the immunomodulatory preparation of e example M364520 [Explanation of main component symbols] 1 Structure of immunomodulatory preparation 10 Carrier 20 Immunomodulating powder layer Coating layer 30