201136616 六、發明說明： 【發明所屬之技術領域】 本發明是有關於一種腸溶緩釋微粒，特別是有 於-種多層次膜衣使微粒遇胃酸後能不被胃酸立即 解，達到降低胃酸破壞及&長釋放有效成份的時間: 【先前技術】 ^目前一般口服藥品或健康食品，常因效性成份未201136616 VI. Description of the invention: [Technical field to which the invention pertains] The present invention relates to an enteric-coated sustained-release microparticle, in particular to a multi-layered film coating, which enables the microparticles to be immediately decomposed by gastric acid after encountering gastric acid, thereby reducing gastric acidity. Destruction and & Long release of active ingredients: [Prior Art] ^ Currently oral or healthy foods, often due to ineffective ingredients
受保護㈣放㈣過短㈣響其料吸收，造 文阻的因料藥^紐康食^之效性成份經過胃部 胃酸分解，使其效性成份到達腸道時已失效或其效性 成伤不足，進而影響藥品或健康食品在腸道之 生體利用率。 及 持續 失長效作 之發生。 考量 經驗從事 緩釋微粒 降低被胃 吸收利用 產領域， 型技術。 样狹型的樂品，可能因胃酸分解導致藥品喪 用或導致藥物劑量全部釋出，引起不良反應 到先前技術中的缺陷，本案發明人基於多年 研究並多次錢，遂於本發明提出—種腸溶 ，利用多層次膜衣遇胃酸後能保護效性成份 酸之分解，以改善藥品或健康食品在腸道之 率。本發明不僅可用於藥品、健康食品的生 更可以應用於醫藥產業做改善劑型生產之新 201136616 【發明内容】 有鑑於此，本發明之目的 3 微粒，其包含一核心，一保護=在，供一種腸溶緩釋 材質能在人體中緩慢崩解效性成份及緩釋 腸溶膜衣，包覆該解且=::效=份，其 出，達到腸溶緩釋之效果。 更。亥核〜所含成份釋 此外，該核心係以下列步驟製成：Protected (4) Put (4) too short (4) Responding to the absorption of the material, the material of the resistance to the resistance of the drug ^ New Kang food ^ The effectiveness of the ingredients through the gastric acid decomposition of the stomach, its effective ingredients have reached the intestinal tract has failed or its effectiveness Insufficient injury, which in turn affects the bioavailability of drugs or healthy foods in the intestines. And the continued use of long-lasting effects. Consider the experience of slow release microparticles to reduce the absorption and utilization of the stomach, the type of technology. The narrow-type music may cause the drug to be ruined due to decomposition of gastric acid or cause the drug dosage to be completely released, causing adverse reactions to the defects in the prior art. The inventor of the present invention has based on many years of research and many times, and is proposed by the present invention - Intestinal dissolution, the use of multi-layer film clothing in the case of gastric acid can protect the decomposition of acidity of effective ingredients to improve the rate of drugs or healthy food in the intestines. The present invention can be applied not only to medicines, health foods, but also to the pharmaceutical industry to improve the production of the dosage form. 201131616 [Invention] In view of the above, the object of the present invention 3 particles, which comprise a core, a protection = in, for An enteric-soluble sustained-release material can slowly disintegrate an effective ingredient in a human body and a sustained-release enteric film coat, and coat the solution and =:: effect = part, and the effect of the enteric dissolution is achieved. more. Hai nuclear ~ contains the ingredients released In addition, the core is made by the following steps:
步驟1·提供一效性成份並與溶劑混合； 步驟2 .以擠壓方式製成條狀形式效性成份； 及 步驟3:將該條狀形式效性成份製成粒狀形式； 步驟4 :供乾，即得效性成份之該核心。 使 腸溶緩釋微粒，其中至少包含釋放層及保護岸 Ί 谷緩釋微粒能逐層釋放以達到緩釋效果。θ 八其中一腸溶緩#微粒之核心係為糖蕊且含效性 刀，粒徑係為100微米（_)至1〇〇〇微米（❿）之間成 而，核心包覆保護層後，其粒 至3000微米（μπη)之間。 愀不（μηα) 承上所述，因依本發明之腸溶緩 下優點： 令以 羽/1i此腸溶緩釋微粒包含的多層次緩釋膜衣可解決 $知樂品或健康食品到達腸道後遭胃酸分解破壞之 (2)此腸溶緩釋微粒可以以膠囊或錠劑之形式做 健康食品或醫藥品。 句 201136616 【實施方式】 本發明人經過廣泛而深入的研究和實驗，最終找 到一種腸溶緩釋微粒，多種試驗表明，所述的含緩釋 層之腸溶緩釋微粒可增加藥品或健康食品之效性成份 在人體之生物吸收率。基於此本發明得以完成。 ▲為讓本發明之上述目的、特徵和優點更明顯易 懂，以下特舉依本發明之腸溶緩釋微粒之較佳實施 例，並配合所附相關圖式第丨圖及第2圖，做詳細說 明如下’為使便於理解，實施例中之相同元件係以相 同之符號標示來說明。 請參閱第1圖，其係為本發明之一腸溶緩釋微粒 之第一實施例之示意圖。此微粒包含一釋放層u，將 部分有效成份包覆在最外層，用以方便效性成份在短 時間内之釋放，一保護層12，其為腸溶膜衣，做為微 粒核心及主要有效成份之保護層，可以防止核心區域 遇胃酸後遭分解，可有效降低胃酸破壞、拉長釋放有 效成份之時間及提高身體利用率，一核心區域13，其 為糖蕊及有效成份主要儲存區域，核心區域受腸溶膜 衣包覆，通過胃酸後於腸道開始釋放出有效成份。 請參閱第2圖’其係為本發明之腸溶緩釋微粒之 核心之製造流程之示意圖。此製造流程包含步驟 S2卜用以將效性成份及溶劑混合，步驟S22，用以將 效性成份及溶劑混合後之產物，以擠壓方式製成條狀 形式效性成份，步驟S23 ’用以將條狀形式效性成份 切製成粒狀形式效性成份，步驟S24，用以將製成粒 狀形式後之效性成份烘乾後即得以效性成份為主成份 201136616 之核心。 取300毫克之腸溶緩釋微粒充填入膠囊，此膠囊 可做為健康食品或醫藥品；均勻混合的腸溶緩釋微粒 亦可添加乳糖、澱粉或纖維素等賦型劑以加壓方式打 成錠劑，此錠劑可做為健康食品或醫藥品。 本發明僅對上述實施例加以詳細說明，但熟悉該 項技術者應可明白，在本發明的技術思想範圍内可作 多樣的變形及修飾，該變形及修飾當然包含申請專利 範圍内。 【圖式簡單說明】 第1圖係為本發明之腸溶緩釋微粒之第一實施例之示 意圖； 第2圖係為本發明之腸溶緩釋微粒之核心之製造流程 之示意圖。 【主要元件符號說明】 I ·腸溶緩釋微粒， II :釋放層； 12 :保護層； 13 :核心區域；及 S21〜S24 :步驟。Step 1·providing a first-acting ingredient and mixing with a solvent; Step 2. Forming a strip-shaped form-active ingredient by extrusion; and Step 3: forming the strip-form form-active ingredient into a granular form; Step 4: For the core, the core of the effective ingredient. The enteric-coated sustained-release microparticles, wherein at least the release layer and the protective shore-salt release-release particles can be released layer by layer to achieve a sustained release effect. θ 八 八 八 八 八 八 八 八 八 八 八 八 八 八 八 八 八 八 八 八 八 八 八 八 八 八 八 八 八 八 八 八 八 八 八 八 八 八 八 八 八 八, its particles are between 3000 microns (μπη).愀不(μηα) According to the present invention, the advantage of the enteric solution according to the present invention is as follows: The multi-layered sustained-release film coat containing the feather/1i of the enteric-coated slow-release granule can solve the problem of reaching the knowing product or healthy food. (2) The enteric sustained-release microparticles can be used as a health food or pharmaceutical in the form of capsules or lozenges. Example 201136616 [Embodiment] The inventors have conducted extensive and intensive research and experiments to finally find an enteric sustained-release microparticle, and various tests have shown that the enteric sustained-release microparticle containing a sustained-release layer can increase medicine or health food. The biological absorption rate of the effective ingredient in the human body. Based on this, the present invention has been completed. In order to make the above objects, features and advantages of the present invention more comprehensible, the following is a preferred embodiment of the enteric sustained-release microparticles according to the present invention, and in conjunction with the accompanying drawings, Figures 2 and 2, DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS In order to facilitate understanding, the same elements in the embodiments are denoted by the same reference numerals. Referring to Figure 1, there is shown a schematic view of a first embodiment of enteric sustained release microparticles of the present invention. The microparticles comprise a release layer u, a part of the active ingredient is coated on the outermost layer for releasing the convenient ingredient in a short time, and a protective layer 12, which is an enteric film coat, is used as a particle core and is mainly effective. The protective layer of the component can prevent the core area from being decomposed after suffering from stomach acid, can effectively reduce the damage of gastric acid, lengthen the time of releasing the active ingredient and improve the utilization rate of the body. The core area 13 is the main storage area of the sugar core and the active ingredient. The core area is covered by an enteric film coat, and the active ingredient is released from the intestines after passing through the stomach acid. Please refer to Fig. 2, which is a schematic view showing the manufacturing process of the core of the enteric sustained-release microparticles of the present invention. The manufacturing process comprises the step S2 for mixing the effective component and the solvent, and the step S22, the product for mixing the effective component and the solvent, is formed into a strip form effective component by extrusion, and the step S23' is used. The strip-shaped effective ingredient is cut into a granular form-effective ingredient, and in step S24, the effective ingredient after being formed into a granular form is dried, and the active ingredient is the core of the main ingredient 201136616. Take 300 mg of enteric-coated slow-release microparticles and fill it into capsules. This capsule can be used as a health food or pharmaceutical. Evenly mixed enteric-coated slow-release microparticles can be added by pressure, such as lactose, starch or cellulose. A tableting agent which can be used as a health food or a pharmaceutical. The present invention has been described in detail with reference to the preferred embodiments of the present invention, and it is understood that various modifications and changes may be made without departing from the scope of the invention. BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1 is a schematic view showing a first embodiment of the enteric sustained-release microparticles of the present invention; and Fig. 2 is a schematic view showing the manufacturing process of the core of the enteric sustained-release microparticles of the present invention. [Explanation of main component symbols] I · Enteric-coated delayed-release particles, II: release layer; 12: protective layer; 13: core region; and S21 to S24: steps.