200930426 六、發明說明： C發明戶斤屬之技術領域3 發明領域 5 ❹ 10 15 ❹ 20 本發明係有關於一種注射器系統，其可以高擴散懸浮 形式注射藥物，以及一藥物容器。 L先前技術3 發明背景 預先填充以及匣式注射器已廣泛地被接受為一種較佳 的注射系統，其由於安全及方便使用以注射藥物。然而， 此種注射器僅適用於流體的藥物。因此，若為在流體形式 下的藥物不穩定，則須使用預先填充之雙室，其中粉末及 溶劑式的藥物以一堆桿分開，且藉由按壓堆桿而混合，並 在執行注射之前變成溶液。 然而，此種預先填充之雙室注射器僅適用於以凍乾法 製成的粉末形式之藥物，即，高溶解性的藥物。若為以一 種喷灑乾燥方法製成的粉末藥物，則沒有一種適合的預先 填充之注射器可用以射出藉由混合藥物及一擴散媒介而獲 得的懸浮形式之藥物。此外，當一注射器以懸浮形式之藥 物填充後，由於重力的不同，在使用壽命中，該懸浮液會 分開，成為一粉末層，以及一懸浮媒介層。習知的注射器 很難再混合該等分開的層。 因此，擬注射懸浮形式的粉末藥物大體上填充至玻璃 瓶中。當須要注射填充在玻璃瓶中的粉末時，懸浮媒介填 充至玻璃瓶中，以與粉末藥物混合，然後，藉由振動玻璃 3 200930426 瓶而獲得的懸浮形式下的藥物為一可拋式注射器所汲出。 然而，就某些粉末藥物而言，使其懸浮很困難，費時，且 須依賴操作者的技巧。此外，整個操作會造成安全的問題。 因此，由於自行注射藥物很困難，需要長期注射的病人必 5 須每次跑去醫院。此外，若懸浮媒介是油，則由於油的高 黏度，很難以一可拋式注射器汲出懸浮式的藥物。相當大 量的懸浮液黏在玻璃瓶的内壁，因而造成自玻璃瓶中溢出 0.2ml的藥物。 人們十分需要一種安全且方便的注射器系統，其可使 10 用於在注射懸浮式藥物之前的片刻内方可混合粉末藥物與 懸浮媒介狀況。 t：發明内容3 發明概要 因此，本發明的一個目的是備置一種注射器系統，其 15 可以高擴散懸浮形式分配由數種方法獲得的粉末藥物。 依據本發明的一實施例，其備置一種注射器系統，其 包括：一室；一密封單元，其用以密封該室的一上部，且 可在該室中滑動；一藥物及溶劑容納部，其為該室及密封 單元所界定，且用以容納一藥物以及一溶劑；以及一混合 20 改良元件，其藉由在藥物及溶劑容納部中移動而協助藥物 及溶劑之混合。 依據本發明的另一實施例，其備置一注射器系統，其 包括一注射器，該注射器具有一室，用以密封該室的一上 部，且可在該室内滑動的一第一密封單元，以及該室及第 200930426 一岔封單元所界定，且容納一藥物的一藥物容納部 :以及 5 Ο 10 15 ❹ 20 -溶劑容器，其包括-室，用以密封該室的一上部，且可 在§亥室内滑動的-第二密封單元，該室及第二密封單元所 界疋，且谷納一溶劑的一溶劑容納部，以及配置成鄰接第 二密封單元的一上側的一注射器接受器。該注射器藉由嵌 入該注射器接收器中，並刺穿第二密封元件即可與溶劑 容器以流體相通。 依據本發明的另一實施例，其備置一注射器系統，其 包括.一注射器，該注射器包括一室，用以密封該式的一 上部，且可在該室中滑動的一第一密封單元，以及該室以 及第一密封單元所界定，且容納一溶劑的一溶劑容納部； 以及一藥物容器，其包括一室，用以密封該室的一上部， 且可在該室中滑動的一第二密封單元，該室及第二密封單 元所界定，且容納一藥物的一藥物容納部，以及一注射器 接收器，其配置成鄰接第二密封單元的一上側，其中該注 射器可藉由嵌入該注射器接收器中，並刺穿該第二密封元 件而與藥物容器以流體相通。 依據本發明的另一實施例，其備置一藥物容器，其自 注射器系統中移開，以儲存懸浮式的藥物。 依據本發明的數個實施例，具有一藥物混合改良元件 的一注射器系統，以及具有一注射器以及以一藥物及一溶 劑預先填充的一容器，且具有一藥物混合改良元件的一注 射器系統有助於均勻地混合藥物及溶劑，以形成一懸浮 液，且可在儲存時，再次自懸浮液的分開層形成懸浮液， 5 200930426 因此以數種方法獲得的粉末藥物可在相當高的擴散懸浮形 式下被分配。 圖式簡單說明 本發明的上述及其他目的及特徵在下文藉由實施例及 5 圖式之說明中更加的清楚，其中： 第1圖顯示依據本發明的一第一實施例的一注射器系 統之一橫截面圖； 第2A圖顯示依據本發明的一第二實施例的一第一實例 的注射器系統的一橫截面圖； 10 第2B圖顯示形成依據本發明的一第二實施例的該第一 實例的一注射器系統的一溶劑容器的一橫截面圖； 第2C圖顯示形成依據本發明的第二實施例的該第一實 例的一注射器系統的一注射器的一橫截面圖； 第2D圖顯示形成依據本發明的第二實施例的該第一實 15 例的一注射器系統的操作步驟； 第2E圖顯示依據本發明的第二實施例的一第二實例的 一注射器系統的一橫截面圖； 第2F圖顯示形成依據本發明的第二實施例的一第二實 例的一注射器系統的一溶劑容器的一橫截面圖； 20 第2G圖顯示形成依據本發明的第二實施例的一第二實 例的一注射器系統的一橫截面圖； 第2 Η圖顯示形成依據本發明的第二實施例的該第二實 例的一注射器系統的操作步驟； 第3Α圖顯示依據本發明的一第三實施例的一注射器系 200930426 統的橫截面圖； 第3 Β圖顯示形成依據本發明的第三實施例的一注射器 系統的一藥物容器的一橫截面圖； 5 Ο 10 15 第3 C圖形成依據本發明的第三實施例的—注射器系統 的一注射器的橫截面圖； 第3D及3Ε圖依序地顯示依據本發明的第三實施例的 一注射器系統的操作步驟的橫截面圖；以及 第4Α及4Β圖顯示用於依據本發明的第三實施例的該 注射器系統的例示藥物容器的橫截面圖。 【實施方式;| 較佳實施例之詳細說明 在本發月中，注射器室"為一習知的注射器之一部 份’譬如，一桶狀部’ 一匡等，其中一針可嵌入注射器的 下端部’且注射器的上部可藉由適當的密封元件而隔離。 此外，、密封元件〃為一適合的元件，譬如，習知注射 器的一堆桿，其隔離注射器的室的上部，俾以在該室中界 定一空間。混合元件可藉由在該室中的-桿而上下移動。 此外混合改良元件，，用以混合配置在注射器的室中 或藥物容器t的藥物及溶劑，且其以特定重力以或超過2 的材料或以隋性或保護物質塗敷的材料製成，因而不為 藥物及溶劑影響’且不會對藥物及溶劑造成影響。此種材 料為，譬如，不銹鋼，玻璃，塑膠，陶瓷等。在這些材料 中’不銹鋼至較佳的。就不銹鋼而言，USU316L是較佳的 用於製造藥物之容器以及注射器的針㈣料。考慮到穩定 20 200930426 性，最好使用後處理步驟，譬如，電解拋光，及惰性處理。 此外，混合改良元件的形狀及數量可在無特定限制下加以 改良，譬如，就本發明的第一及第二實施例而言，大體上， 可使用具有直徑為5mm或小於5mm之球形或類似球形的一 5 個或數個混合改良元件，且它亦可具有與室的橫截面形狀 一致的一圓筒形。混合改良元件可具有沿著中心軸具有一 孔的圓筒形或類似形狀，使得當溶劑的黏度在混合藥物及 溶劑時十分高或增加，或藥物的量十分大時，混合改良元 件可在一藥物容納部内，無困難地往復移動，因而較容易 10 排出混合的懸浮液。此外，在本發明的第三實施例中，最 好混合改良元件具有一圓筒形，或類似的形狀，且沿著其 中心軸具有一孔，俾以防止針穿過其中而受到破壞，並有 助於混合懸浮液的排出，最好沿著中心軸具有孔的圓筒形 之混合改良元件之直徑相對於室的一内徑之比例在大於 15 0.7及小於1的範圍内，且最好在0.85至0.98之間。此混合改 良元件之高度可依據藥物及溶劑的特性，藥物及溶劑的 量，填充的藥物及溶劑的量，以及混合改良元件之外及内 徑而改變。然而，該高度必須足以防止混合改良元件以側 向地旋轉，以及破壞注射器針的一點。該孔亦必須具有適 20 合的形狀及尺寸，俾以阻止針在混合過程中受到破壞。此 外，最好在藥物容器的底端側上的圓筒形混合改良元件之 一端部具有圓形，以有助於藥物容器中的底部角落部份處 之混合。 此外，”溶劑容器〃以及 >藥物容器〃係指具有内部空 200930426 ^以儲存藥物或溶劑，且可配合注射器並與其以流體相 、 "" 如第4A及4B圖所不，其一端部密封的~管，— 預先填充的注射器，一匣，一桶狀部等可用於容器中。 右以習知注射器之一部份的桶狀部，匣等用作為、、溶 5 劑容^ w °以及 '"藥物容器”，俾以分配藥物，且藥物及溶劑 I#器之下端部密封後被混合，則封口被移開，俾以插入200930426 VI. INSTRUCTIONS: C TECHNICAL FIELD OF THE INVENTION FIELD OF THE INVENTION Field of the Invention 5 ❹ 10 15 ❹ 20 The present invention relates to an injector system for injecting a drug in a high diffusion suspension form, and a drug container. L Prior Art 3 Background of the Invention Prefilled and sputum syringes have been widely accepted as a preferred injection system for safe and convenient use for injecting drugs. However, such a syringe is only suitable for fluid medications. Therefore, if the drug in fluid form is unstable, a pre-filled dual chamber must be used in which the powder and solvent-based drugs are separated by a stack of rods and mixed by pressing the stack and become before the injection is performed. Solution. However, such pre-filled dual chamber syringes are only suitable for drugs in the form of powders prepared by lyophilization, i.e., highly soluble drugs. In the case of a powdered drug prepared by a spray drying method, no suitable prefilled syringe can be used to eject a drug in suspension form obtained by mixing a drug and a diffusion medium. In addition, when a syringe is filled with a drug in suspension, the suspension separates into a powder layer and a suspension medium layer over its useful life due to gravity. Conventional syringes are difficult to mix the separate layers. Therefore, the powder drug to be injected in suspension form is substantially filled into a glass bottle. When it is necessary to inject the powder filled in the glass bottle, the suspension medium is filled into the glass bottle to be mixed with the powder medicine, and then the medicine in suspension form obtained by vibrating the glass 3 200930426 bottle is a disposable syringe. Pull out. However, for some powdered drugs, it is difficult, time consuming, and dependent on the skill of the operator. In addition, the entire operation poses a safety issue. Therefore, since it is difficult to inject drugs by themselves, patients who need long-term injections must go to the hospital every time. In addition, if the suspension medium is oil, it is difficult to remove the suspended drug in a disposable syringe due to the high viscosity of the oil. A considerable amount of the suspension adhered to the inner wall of the glass bottle, causing 0.2 ml of drug to escape from the glass bottle. There is a great need for a safe and convenient syringe system that allows 10 to be used to mix powdered drug and suspension media conditions just prior to the injection of the suspension drug. t: SUMMARY OF THE INVENTION Summary of the Invention Accordingly, it is an object of the present invention to provide an injector system that can dispense powdered medicaments obtained by several methods in a high diffusion suspension format. According to an embodiment of the invention, there is provided an injector system comprising: a chamber; a sealing unit for sealing an upper portion of the chamber and slidable in the chamber; a drug and solvent receiving portion, Defining the chamber and the sealing unit to accommodate a drug and a solvent; and a mixing 20 modifying element assisting in the mixing of the drug and the solvent by moving in the drug and solvent containing portions. In accordance with another embodiment of the present invention, an injector system is provided that includes a syringe having a chamber for sealing an upper portion of the chamber and a first sealing unit slidable within the chamber, and the And a pharmaceutical container defined by a seal unit and containing a drug: and a 5 Ο 10 15 ❹ 20 - solvent container comprising a chamber for sealing an upper portion of the chamber, and a second sealing unit that slides inside the chamber, the chamber and the second sealing unit are bounded, and a solvent containing portion of the solvent is disposed, and a syringe receiver disposed adjacent to an upper side of the second sealing unit. The syringe is in fluid communication with the solvent container by being inserted into the syringe receiver and piercing the second sealing member. According to another embodiment of the present invention, there is provided an injector system including a syringe, the syringe including a chamber for sealing an upper portion of the type, and a first sealing unit slidable in the chamber, And a solvent receiving portion defined by the chamber and the first sealing unit and containing a solvent; and a drug container including a chamber for sealing an upper portion of the chamber and slidable in the chamber a second sealing unit, defined by the chamber and the second sealing unit, and accommodating a drug receiving portion of a drug, and a syringe receiver configured to abut an upper side of the second sealing unit, wherein the syringe can be embedded by the The syringe receiver is inserted into the second sealing element to be in fluid communication with the drug reservoir. In accordance with another embodiment of the present invention, a drug container is provided that is removed from the syringe system to store the suspended drug. According to several embodiments of the present invention, a syringe system having a drug mixing improving element, and a syringe system having a syringe and a container pre-filled with a drug and a solvent, and having a drug mixing improving component The drug and the solvent are uniformly mixed to form a suspension, and upon storage, the suspension is again formed from the separated layer of the suspension, 5 200930426 so that the powdered drug obtained by several methods can be in a relatively high diffusion suspension form. It is assigned below. BRIEF DESCRIPTION OF THE DRAWINGS The above and other objects and features of the present invention will become more apparent from the following description of the embodiments and FIG. 5 wherein: FIG. 1 shows a syringe system in accordance with a first embodiment of the present invention. a cross-sectional view; FIG. 2A shows a cross-sectional view of a first embodiment of a syringe system in accordance with a second embodiment of the present invention; FIG. 2B shows the formation of a second embodiment in accordance with the present invention. A cross-sectional view of a solvent container of an injector system of an example; FIG. 2C is a cross-sectional view of a syringe forming a syringe system of the first example of the second embodiment of the present invention; An operational step of forming a syringe system of the first embodiment according to the second embodiment of the present invention; and FIG. 2E is a cross section of a syringe system according to a second example of the second embodiment of the present invention. Figure 2F shows a cross-sectional view of a solvent container forming a syringe system according to a second example of the second embodiment of the present invention; 20 Figure 2G shows formation according to the present invention A cross-sectional view of a syringe system of a second example of a second embodiment of the invention; FIG. 2 is a view showing the operational steps of forming an injector system of the second example in accordance with the second embodiment of the present invention; 1 is a cross-sectional view showing a syringe system 200930426 according to a third embodiment of the present invention; and FIG. 3 is a cross-sectional view showing a drug container forming a syringe system according to a third embodiment of the present invention; 5 第 10 15 FIG. 3C is a cross-sectional view showing a syringe of the injector system according to the third embodiment of the present invention; FIGS. 3D and 3D are sequentially showing an injector system according to a third embodiment of the present invention. A cross-sectional view of the operational steps; and Figures 4 and 4 show cross-sectional views of an exemplary drug container for the injector system in accordance with a third embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS In the present month, the syringe chamber is a part of a conventional syringe, such as a barrel, a barrel, etc., one of which can be inserted into a syringe. The lower end 'and the upper portion of the syringe can be isolated by suitable sealing elements. Further, the sealing member 〃 is a suitable member, such as a stack of conventional syringes that isolates the upper portion of the chamber of the syringe to define a space in the chamber. The mixing element can be moved up and down by a rod in the chamber. Further, a mixing improved component for mixing a drug and a solvent disposed in a chamber of the syringe or the drug container t, and which is made of a material having a specific gravity of or more than 2 or a material coated with an inert or protective substance, thereby Does not affect drugs and solvents' and does not affect drugs and solvents. Such materials are, for example, stainless steel, glass, plastic, ceramics, and the like. Among these materials, 'stainless steel is preferred. In the case of stainless steel, USU 316L is a preferred container for the manufacture of pharmaceuticals and needles for syringes. Considering the stability of 2009 30426, it is best to use post-treatment steps such as electropolishing and inert treatment. Further, the shape and number of the mixed improvement elements can be modified without any particular limitation. For example, in the first and second embodiments of the present invention, generally, a spherical shape or the like having a diameter of 5 mm or less can be used. One or a plurality of mixed modified elements of a sphere, and it may also have a cylindrical shape conforming to the cross-sectional shape of the chamber. The hybrid modifying element may have a cylindrical shape or the like having a hole along the central axis such that when the viscosity of the solvent is very high or increased when the drug and the solvent are mixed, or the amount of the drug is very large, the mixing improving element may be in a The drug accommodating portion reciprocates without difficulty, so that it is easier to discharge the mixed suspension. Further, in the third embodiment of the present invention, it is preferable that the mixing improving member has a cylindrical shape or the like and has a hole along its central axis to prevent the needle from being broken therethrough and has Preferably, the ratio of the diameter of the cylindrical mixing improvement element having a hole along the central axis to the inner diameter of the chamber is greater than 15 0.7 and less than 1 and preferably Between 0.85 and 0.98. The height of the hybrid improved component can vary depending on the nature of the drug and solvent, the amount of drug and solvent, the amount of drug and solvent being filled, and the addition and internal diameter of the mixed modified component. However, this height must be sufficient to prevent the mixing improved element from rotating laterally and damaging a point of the syringe needle. The hole must also have a suitable shape and size to prevent the needle from being damaged during mixing. Further, it is preferable that one end portion of the cylindrical mixing improving member on the bottom end side of the drug container has a circular shape to facilitate mixing at the bottom corner portion in the drug container. In addition, "solvent container 〃 and > drug container 〃 means having an internal space 200930426 ^ to store a drug or solvent, and can be used with a syringe and with a fluid phase, "" as shown in Figures 4A and 4B, one end Partially sealed ~ tube, - pre-filled syringe, a bowl, a barrel, etc. can be used in the container. Right to the barrel of a part of the conventional syringe, sputum, etc. used as, dissolve 5 doses ^ w ° and '"pharmaceutical container", 分配 to dispense the drug, and the lower end of the drug and solvent I# is sealed and mixed, then the seal is removed, 俾 insert
I 在外’若管或構形成在下部上無密封的桶狀部及匣等 〇 肖作為以分配藥物，則可制包括在注射n统中的注射 器。 以下將配合附圖說明本發明的數個實施例。 第1圖顯不依據本發明的一第一實施例的一注射器系 統，主射器系統包括—桶狀部份15;插入桶狀部份15的下 h卩的針，选封桶狀部15的一上部的一堆桿13 ;以及插 入堆才干13的上部’以移動堆桿13的—桿17。—藥物容納部 μ π形成在桶狀部15及堆桿13界定的—空間中。一藥物填充 〇 i藥物容納部11中’而—混合改良元件12配置在 藥物容納 1中’俾以改良藥物以及一溶劑的混合。此外，注射器 系統的一針18可為一保護蓋19所保護。 擬射出的粉末藥物填充在藥物容納部^中，並藉由射 2〇出溶義轉換成—可射出狀態，俾以製造懸浮液。 藥物可 以另-種形式’譬如懸浮液填充在藥物容納部u中。 在射出以粉末藥物填充的藥物容納部11中的溶劑後， 主射器系統以其-縱向授動，俾以改良粉末藥物及溶劑之 混合，而混合改良元件12在藥物容納部11中往復地移動。 9 200930426 因而在一短時間内均勻地擴散藥物至溶劑中，並防止藥物 黏至藥物容納部11的一下壁。此外，若一藥物在懸浮形式 下可保持長時間的穩定，則懸浮形式的藥物儲存在備有混 合改良元件12的藥物容納部η中。為分配藥物，在儲存中 5 沉殿的一藥物在藉由僅攪動儲存的注射器系統數次而轉換 成懸浮形式的一均勻擴散之藥物。 依據本發明的乾燥粉末可以數種方法製造，譬如，快 速溶劑移除法’噴灑乾燥法，滾輪乾燥法，溶劑沉澱法， 以及凍乾法。此外，依據本發明的注射器系統可方便地分 10配蛋白質藥物，長期釋放式消化系統藥物，以及過去以習 知的再填充注射器分配的懸浮式疫苗。 依據本發明的注射器系統之構件中，桶狀部，堆桿， 桿，以及針可具有用於醫藥界中的任何習知材料，形狀， 及尺寸。 15 依據本發明的具有混合改良元件12的注射器系統可方 便用以分配尚擴散懸浮式混合藥物，而該混合藥物可簡單 地以縱向授動混合粉末藥物及溶劑之動作而獲得。 第2A至2H圖顯示依據本發明的一第二實施例的用以 分配藥物的例示注射器系統。第2八圖顯示依據本發明的第 20二實施例之例示注射器系統。參看第2A圖，注射器系統包 括一溶劑容器210以及配合溶劑容器21〇，且以一藥物填充 的一注射器220。 如第2B圖中所示的溶劑容器21〇在其下端部可具有圓 形或截角邊緣，俾以防止它在組合時被穿透堆桿213的一針 200930426 尖所破壞。溶劑容器210包括一桶狀部215 :溶劑容納部 2Π;密封溶劑容納部211且可以一縱向滑動的一堆桿213， 以及以其-上端方向鄰接堆桿213而配置的—注射器接收 5 ❹ 10 15 ❹ 20 器214。在桶狀部215的上端部上，設有向外延伸以方便操 作的一支持元件216。 此外，如第2C圖t所示的注射器22〇包括一桶狀部 225 ; —藥物容納部221 ;密封藥物容納部221，且可以其縱 向滑動的-堆桿223 ;嵌入桶狀部225的—端部的一針228 ; 在桶狀部225中用以移動堆桿223的—桿227;以及設在桶狀 部225的-上端部上，俾以支持桿227之操作的一支持元件 226。此外，注射器22〇的針228可為一針保護蓋229保護。 此外，藥物容納部221可備有一混合改良元件222，以協助 藥物及溶劑之混合。 第2 D圖顯示第2 a圖中的注射器系統的操作步驟。溶劑 容器210及注射器220的溶劑容納部211及藥物容納部221分 別填充溶劑及藥物，而注射器22〇的針228刺穿溶劑室的堆 才干213，俾以接觸溶劑。其後，溶劑容器210的支持元件216 以及注射器220的支持元件226以第2D圖的第一圖中所示的 箭頭方向一起推動，然後，由於作動在溶劑容納部211上的 壓力，當堆桿223向後移動時，溶劑傳送至注射器220的藥 物容納部221。然後，如第2D圖的第二圖中所示，藥物及溶 劑藉由縱向地攪動注射器系統而混合。可選擇地使用的混 合改良元件222用以協助混合。最後，混合的藥物可在移開 注射器220後分配。 11 200930426 第2E圖顯示依據本發明的第二實施例的其他注射器系 統。第2E圖中所示的溶劑容器210,可為第2F圖中所示的一 習知的預先填充式溶劑系統，其包括一桶狀部215，；溶劑 容納部211’ ；密封溶劑容納部211，，且可在其縱向下滑動的 5 —堆桿213’，以及配置成b比鄰在其一上端方向下的一注射 器接收器214’。在桶狀部215,的上端部上設有一向外延伸的 支持元件216’，以方便操作。桶狀部215,的下端部可以密封 裝置密封’如Luer鎖230,以及Luer鎖鞘231，。 注射器系統藉由插入注射器220,的針28’至注射器接收 10 器214’中而形成’如第2G圖所示。針228,可以一針保護蓋 229’所保護。在注射器22〇,的上端部設有一支持元件226,， 以便於操作。雖然支持元件226,的形狀與習知可填充式注 射器系統中所使用的相同，但最好支持元件226,的形狀為 在其一中間部份上有一凹槽，以配合桿227,的一上端部， 15如此，當桿227’完全推進後，桿227,的整個上端部安裝至凹 槽中’且當桿227’完全地推進後，亦最好支持元件226,與桿 整合’俾以阻止桿227’向後移動，混合改良元件222,亦可用 於此種注射器系統。 第2H圖顯示第2E圖的注射器系統的操作步驟。傳送溶 20劑至藥物容納部221’的操作步驟以及藥物及溶劑之混合與 第2D圖中所示的步驟相同。其後，桿227’插入注射器220’ 中’且支持元件226,與桿227,以第2H圖的第二圖中所示的 方向推動’俾以傳送混合的藥物懸浮液至溶劑容納部 221’。混合的藥物可在移開Luer鎖鞘231，並嵌入針之後被分 12 200930426 配。此時，整個注射器22〇，具有一桿的功能。 5 Ο 10 15 ❹ 20 第3Α至3Ε圖顯示依據本發明的一第三實施例的用以 刀配藥物之注射器系統，其中藥物容器為一管310,如第3Β 圖中所示，官310以一堆桿313密封，俾以界定一藥物容納 〇P311堆桿313的一端上形成藥物容納部311，而堆桿313 的另一端上形成注射器320的一接收器。一混合改良元件 312可插入藥物容納部311中，俾以協助藥物及溶劑之混合。 此外，如第3C圖中所示的注射器32〇包括一桶狀部 325 ; —溶劑容納部321 ;密封溶劑容納部321，且可在其下 一縱向滑動的一堆桿323 ;嵌入桶狀部325的一下端部的一 針328 ’插入堆桿323的一上端部，俾以移動堆桿的一桿 327，以及δ又在桶狀部325的一上端部上，俾以支持桿327之 操作的一支持元件326。一固定元件326，可配置在支持元件 326上，俾以固定支持元件326。此外，注射器的針 可為一針保護蓋329所保護。此外，藥物容納部321可設有 此合改良元件322，以協助藥物及溶劑的混合。雖然支持 元件326可改變’最好支持元件322的—支持部份配置在桶 狀部325的中間部份上，如第3(：圖中所示，因此使用者容易 以-姆指握住管310的下端表面，且以食指及中指握住支持 兀件322’其與在習知的桶狀部之上端部的一翼部上向外延 伸的支持部份不同。此外，注射器32〇的針328可為一針保 護蓋329所保護。 第3D及3E圖依序地顯示第3A圖之注射器系統的操作 步驟。當針328刺穿已填充藥物的藥物容納部311及混合改 13 200930426 良元件312時，注射器320已嵌入填充溶劑的管310的一注射 器接收器314。其後，藉由以第3D圖之第1圖所示的方向分 別推動支持元件326及混合改良元件312,溶劑在推動管310 中的堆桿313至管310的上端方向時，傳送至藥物容納部 5 311 °然後，注射器系統以其縱向攪動，俾以混合藥物及溶 劑。在此攪動過程中，可選擇地使用之混合改良元件312在 藥物容納部311中往復地移動，因而在一短時間内均勻地在 溶劑中擴散藥物。然後’在向後推動堆桿323時，混合的懸 洋液藉由以第3D圖的第3圖中所示的方向，推動管M〇的下 1〇端及支持元件326傳送至注射器320的内部。為了分配混合 懸浮液’注射器320自管中移開。 若由於在混合狀態下儲存時特定重力的不同，混合的 懸=液分成-藥物層以及-溶劑層，則藥物傳送至藥物容 納部311’以再次形成懸浮液，然後，懸浮液傳送回注射器， 15 以便分配。 你祗口樂物及浴劑之後傳送至注射器的方法與 知方法不同。習知的方法’譬如，麵瓶方法，藉由^ 入針至破触之後’拉動注㈣的桿， 的混合藥物懸浮液至注射器。然而，依據本發==瓶 ^例，整個管朝向轉器按壓，俾崎㈣合^ 液，如第3D圖的第3圖中所示。因此，若 ’、物w 混合的黏著劑增加至高於溶劑，大部份的： 度高， 被均勻地傳送。 η樂物懸汙液均 此外，若藥物及溶劑被被填充的量為分配量的兩倍 20 200930426 5 ❹ 10 15 ❹ 20 超過兩倍，則依據本發明的第三實施例的注射器系統適用 於多種劑量的配方之分配。譬如，當藉由均勻地混合在藥 物容器的藥物容器的藥物容納部中的藥物及溶劑而獲得的 混合懸浮液傳送時，僅一預定量的混合的懸浮液被傳送至 注射器，然後，注射器自藥物容器中移開。若分配另一種 藥物，則另一注射器嵌入藥物容器，俾以完成數種藥物之 分配。 同時，用於依據本發明之第三實施例的注射器系統之 藥物容器可用以儲存可保證長期穩定的藥物懸浮液。亦 即，在藥物容器中的儲存藥物懸浮液可藉由在分配之前嵌 入注射器而没出。如此，它亦適用於分配多種劑量的配方。 依據本發明的注射器系統具有較習知玻璃瓶方法簡單 的混合步驟，且可減少藥物之浪費。當混合的懸浮藥物依 據玻璃瓶方法傳送注射器時，若針不浸在混合藥物中，大 部份的空氣可注入注射器中。因此，控制在玻璃瓶中的針 的深度是很重要的。此外，若混合懸浮液非透明的，操作 者無法決定浸入混合藥物中的針的深度，因而須要高技 術。然而，在組合注射器及溶劑或藥物容器之後，依據本 發明的注射器系統之針以一嵌入的深度插入溶劑中，或藥 物容器中。因此，它適於初學者使用，且十分安全，以預 防針的意外，及污染。 本發明已配合實施例說明如上，但須瞭解的是熟悉此 技藝人士可在不脫離申請專利範圍中界定的範圍下做不同 的改變及改良。 15 200930426 L圖式簡單說明3 第1圖顯示依據本發明的一第一實施例的一注射器系 統之一橫截面圖； 第2A圖顯示依據本發明的一第二實施例的一第一實例 5 的注射器系統的一橫截面圖； 第2B圖顯示形成依據本發明的一第二實施例的該第一 實例的一注射器系統的一溶劑容器的一橫截面圖； 第2C圖顯示形成依據本發明的第二實施例的該第一實 例的一注射器系統的一注射器的一橫截面圖； 10 第2D圖顯示形成依據本發明的第二實施例的該第一實 例的一注射器系統的操作步驟； 第2E圖顯示依據本發明的第二實施例的一第二實例的 一注射器系統的一橫截面圖； 第2F圖顯示形成依據本發明的第二實施例的一第二實 15 例的一注射器系統的一溶劑容器的一橫截面圖； 第2G圖顯示形成依據本發明的第二實施例的一第二實 例的一注射器系統的一橫截面圖； 第2H圖顯示形成依據本發明的第二實施例的該第二實 例的一注射器系統的操作步驟； 20 第3A圖顯示依據本發明的一第三實施例的一注射器系 統的橫截面圖； 第3 B圖顯示形成依據本發明的第三實施例的一注射器 系統的一藥物容器的一橫截面圖； 第3C圖形成依據本發明的第三實施例的一注射器系統 16 200930426 的一注射器的橫截面圖； 第3 D及3 E圖依序地顯示依據本發明的第三實施例的 一注射器系統的操作步驟的橫截面圖；以及 第4A及4B圖顯示用於依據本發明的第三實施例的該 注射器系統的例示藥物容器的橫截面圖。I. In the outer tube, if the tube or the structure is formed on the lower portion, the barrel is not sealed, and the crucible is used to dispense the medicine, and the syringe can be included in the injection system. Several embodiments of the invention are described below in conjunction with the drawings. 1 shows a syringe system according to a first embodiment of the present invention. The main emitter system includes a barrel portion 15; a lower needle inserted into the barrel portion 15 and a barrel portion 15 is selected. An upper pile of rods 13; and an upper portion of the stacker 13 to move the rods 17 of the stacker 13. The drug accommodating portion μ π is formed in the space defined by the barrel portion 15 and the stacking rod 13. A drug is filled in the drug receiving portion 11 and the mixing improving member 12 is disposed in the drug containing unit 1 to improve the mixing of the drug and a solvent. Additionally, a needle 18 of the syringe system can be protected by a protective cover 19. The powder medicine to be ejected is filled in the drug accommodating portion, and is converted into an ejectable state by the eliminator to produce a suspension. The drug may be filled in the drug accommodating portion u in another form, such as a suspension. After ejecting the solvent in the drug containing portion 11 filled with the powdered drug, the main emitter system is actuated in the longitudinal direction thereof to improve the mixing of the powder drug and the solvent, and the mixing improving member 12 reciprocates in the drug containing portion 11. mobile. 9 200930426 Thus, the drug is uniformly diffused into the solvent in a short period of time, and the drug is prevented from sticking to the lower wall of the drug containing portion 11. Further, if a drug is stable for a long period of time in a suspended form, the drug in a suspended form is stored in the drug containing portion η provided with the mixed improving member 12. To dispense the drug, a drug in the store is converted to a uniformly diffused drug in suspension by agitating the stored syringe system several times. The dry powder according to the present invention can be produced by several methods, for example, rapid solvent removal method, spray drying method, roller drying method, solvent precipitation method, and lyophilization method. In addition, the injector system in accordance with the present invention can be conveniently dispensed with protein drugs, long-term release digestive system drugs, and suspension vaccines that have been dispensed in the past with conventional refill syringes. In the components of the injector system in accordance with the present invention, the barrel, the plunger, the rod, and the needle can have any of the conventional materials, shapes, and sizes used in the medical arts. The syringe system with the hybrid modifying element 12 according to the present invention can be conveniently used to dispense a still-diffusion-suspended mixed drug which can be obtained simply by longitudinally stimulating the action of mixing the powdered drug with the solvent. Figures 2A through 2H show an exemplary injector system for dispensing medication in accordance with a second embodiment of the present invention. Figure 2 shows an exemplary syringe system in accordance with a twenty-second embodiment of the present invention. Referring to Fig. 2A, the syringe system includes a solvent container 210 and a syringe 220 that is filled with a drug container 21 〇 and filled with a drug. The solvent container 21, as shown in Fig. 2B, may have a rounded or truncated edge at its lower end to prevent it from being broken by the tip of a needle 200930426 penetrating the stack 213 when assembled. The solvent container 210 includes a barrel portion 215: a solvent accommodating portion 2; a stack of rods 213 that seals the solvent accommodating portion 211 and can slide longitudinally, and a syringe that is disposed adjacent to the stacking rod 213 in the upper-end direction thereof to receive 5 ❹ 10 15 ❹ 20 214. On the upper end of the barrel 215, a support member 216 is provided that extends outwardly for ease of operation. Further, the syringe 22A shown in FIG. 2C is configured to include a barrel portion 225; a drug accommodating portion 221; a drug accommodating portion 221, and a longitudinally slidable - stacking rod 223; embedded in the barrel portion 225 - A needle 228 at the end; a rod 227 for moving the stack 223 in the barrel 225; and a support member 226 provided on the upper end of the barrel 225 to support the operation of the rod 227. Additionally, the needle 228 of the syringe 22 can be protected by a needle protection cover 229. Further, the drug containing portion 221 may be provided with a mixing improving member 222 to assist in the mixing of the drug and the solvent. Figure 2D shows the operational steps of the injector system in Figure 2a. The solvent container 210 and the solvent containing portion 211 of the syringe 220 and the drug containing portion 221 are filled with the solvent and the drug, respectively, and the needle 228 of the syringe 22 is pierced by the stack 213 of the solvent chamber to contact the solvent. Thereafter, the support member 216 of the solvent container 210 and the support member 226 of the syringe 220 are pushed together in the direction of the arrow shown in the first diagram of FIG. 2D, and then, due to the pressure on the solvent accommodating portion 211, when the pile is actuated When the 223 moves backward, the solvent is delivered to the medicine containing portion 221 of the syringe 220. Then, as shown in the second diagram of Figure 2D, the drug and solvent are mixed by longitudinally agitating the injector system. A hybrid improved element 222 is optionally used to assist in the mixing. Finally, the mixed drug can be dispensed after removal of the syringe 220. 11 200930426 Figure 2E shows another syringe system in accordance with a second embodiment of the present invention. The solvent container 210 shown in FIG. 2E may be a conventional pre-filled solvent system shown in FIG. 2F, which includes a barrel portion 215, a solvent containing portion 211', and a sealing solvent containing portion 211. And a stacker 213' that is slidable in its longitudinal direction, and a syringe receiver 214' configured to be adjacent to one of its upper ends. An outwardly extending support member 216' is provided on the upper end of the barrel portion 215 for ease of handling. The lower end of the barrel portion 215 can seal the device seal ', such as the Luer lock 230, and the Luer lock sheath 231. The syringe system is formed by inserting the needle 28' of the syringe 220 into the syringe receiving 214' as shown in Fig. 2G. Needle 228 can be protected by a needle protection cover 229'. A support member 226 is provided at the upper end of the syringe 22A for ease of operation. While the support member 226 has the same shape as that used in conventional fillable syringe systems, it is preferred that the support member 226 be shaped to have a recess in a central portion thereof to engage an upper end of the stem 227. For example, when the rod 227' is fully advanced, the entire upper end of the rod 227 is mounted into the groove' and when the rod 227' is fully advanced, it is also preferred to support the element 226 to integrate with the rod to prevent The rod 227' moves rearwardly, mixing the improved element 222, and can also be used in such an injector system. Figure 2H shows the operational steps of the injector system of Figure 2E. The procedure for transferring the solvent 20 to the drug containing portion 221' and the mixing of the drug and the solvent are the same as those shown in Fig. 2D. Thereafter, the rod 227' is inserted into the syringe 220' and the support member 226, with the rod 227, pushes '俾 in the direction shown in the second diagram of FIG. 2H to deliver the mixed drug suspension to the solvent containing portion 221' . The mixed drug can be dispensed after removing the Luer lock sheath 231 and inserting the needle into 12 200930426. At this time, the entire syringe 22 has a function of one rod. 5 Ο 10 15 ❹ 20 Figures 3 to 3 show a syringe system for dicing a drug according to a third embodiment of the present invention, wherein the drug container is a tube 310, as shown in Fig. 3, the official 310 is A stack of rods 313 is sealed to form a drug receiving portion 311 on one end defining a drug containing port P311 stacking rod 313, and a receiver of the syringe 320 is formed on the other end of the stacking rod 313. A mixed modifying element 312 can be inserted into the drug receiving portion 311 to assist in the mixing of the drug and solvent. Further, the syringe 32A as shown in Fig. 3C includes a barrel portion 325; a solvent accommodating portion 321, a solvent accommodating portion 321, and a stack of rods 323 which are slidable in the longitudinal direction thereof; A needle 328' of the lower end of the 325 is inserted into an upper end of the stacking rod 323 to move a rod 327 of the stack, and δ is again on an upper end of the barrel 325 to support the operation of the rod 327. A support component 326. A securing member 326 can be disposed on the support member 326 to secure the support member 326. In addition, the needle of the syringe can be protected by a needle protection cover 329. Further, the drug containing portion 321 may be provided with the modified member 322 to assist in the mixing of the drug and the solvent. Although the support member 326 can change the 'best support member 322' - the support portion is disposed on the intermediate portion of the barrel portion 325, as shown in the third (: figure, so the user can easily hold the tube with the thumb The lower end surface of the 310, and holding the support member 322' with the index and middle fingers is different from the support portion extending outwardly on a wing of the upper end of the conventional barrel. Further, the needle 32 of the syringe 32 is closed. It can be protected by a needle protective cover 329. Figures 3D and 3E show the steps of the injector system of Figure 3A in sequence. When the needle 328 pierces the drug-filled drug containing portion 311 and the mixed device 13 200930426 good component 312 At this time, the syringe 320 has been inserted into a syringe receiver 314 of the solvent-filled tube 310. Thereafter, the support member 326 and the mixing improving member 312 are respectively pushed in the directions shown in Fig. 1 of the 3D drawing, and the solvent is pushed in the tube. When the stacking rod 313 in the direction 310 is in the upper end direction of the tube 310, it is transferred to the drug accommodating portion 5 311 °, and then the syringe system is agitated in its longitudinal direction to mix the drug and the solvent. During the agitation process, the mixing can be optionally used. Improved component 312 The drug accommodating portion 311 moves reciprocally, thereby uniformly diffusing the drug in the solvent in a short time. Then, when the stacking rod 323 is pushed backward, the mixed suspended liquid is as shown in Fig. 3 of the 3D drawing. In the direction shown, the lower end of the push tube M〇 and the support member 326 are transferred to the interior of the syringe 320. In order to dispense the mixed suspension 'the syringe 320 is removed from the tube. If the specific gravity is different due to storage in the mixed state The mixed suspension = liquid is divided into a drug layer and a - solvent layer, and the drug is delivered to the drug receiving portion 311' to form a suspension again, and then the suspension is transferred back to the syringe, 15 for dispensing. Your mouth and body and bath The method of delivery to the syringe is then different from the known method. For example, the method of noodle bottle, by mixing the needle to the rod after pulling the needle (four) after the break, is to mix the drug suspension into the syringe. Hair == bottle example, the whole tube is pressed toward the rotator, and the 俾崎(四) ^液液, as shown in Figure 3 of Figure 3D. Therefore, if the adhesive of ', w mixed increases above the solvent, partial: High, evenly delivered. η music suspended liquids are additionally, if the drug and solvent are filled in an amount of twice the amount of 20 20 30 30 30 30 30 30 30 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 The injector system of the embodiment is suitable for dispensing a plurality of dosage formulations, for example, when a mixed suspension obtained by uniformly mixing a drug and a solvent in a drug container of a drug container of a drug container is delivered, only a predetermined amount The mixed suspension is delivered to the syringe, which is then removed from the drug container. If another drug is dispensed, another syringe is inserted into the drug container to complete the dispensing of several drugs. Meanwhile, a drug container for an injector system according to a third embodiment of the present invention can be used to store a drug suspension which can ensure long-term stability. That is, the stored drug suspension in the drug container can be eliminated by embedding the syringe prior to dispensing. As such, it is also suitable for dispensing multiple doses of the formulation. The syringe system according to the present invention has a simple mixing step compared to the conventional glass bottle method and can reduce the waste of the drug. When the mixed suspended drug is delivered to the syringe according to the glass bottle method, most of the air can be injected into the syringe if the needle is not immersed in the mixed drug. Therefore, it is important to control the depth of the needle in the glass bottle. In addition, if the mixed suspension is non-transparent, the operator cannot determine the depth of the needle immersed in the mixed drug, and thus requires high technology. However, after combining the syringe with the solvent or drug container, the needle of the syringe system according to the present invention is inserted into the solvent, or the drug container, at an embedded depth. Therefore, it is suitable for beginners and is very safe to prevent needle accidents and contamination. The present invention has been described in connection with the embodiments, and it is understood that those skilled in the art can make various changes and modifications without departing from the scope of the invention. 15 200930426 L. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a cross-sectional view showing a syringe system according to a first embodiment of the present invention; FIG. 2A is a first example showing a second embodiment according to a second embodiment of the present invention. A cross-sectional view of a syringe system; FIG. 2B shows a cross-sectional view of a solvent container forming a syringe system of the first example in accordance with a second embodiment of the present invention; FIG. 2C shows formation in accordance with the present invention A cross-sectional view of a syringe of a syringe system of the first example of the second embodiment; 10 2D shows the operational steps of forming a syringe system of the first example in accordance with the second embodiment of the present invention; 2E is a cross-sectional view showing a syringe system according to a second example of the second embodiment of the present invention; and FIG. 2F is a view showing a syringe forming a second embodiment according to the second embodiment of the present invention. A cross-sectional view of a solvent container of the system; FIG. 2G shows a cross-sectional view of a syringe system forming a second example of the second embodiment of the present invention; FIG. 2H shows formation Operational steps of a syringe system of the second example according to the second embodiment of the present invention; 20 Figure 3A shows a cross-sectional view of a syringe system in accordance with a third embodiment of the present invention; Figure 3B shows formation A cross-sectional view of a drug container of a syringe system in accordance with a third embodiment of the present invention; FIG. 3C is a cross-sectional view of a syringe of a syringe system 16 200930426 in accordance with a third embodiment of the present invention; Figures D and 3E show, in order, a cross-sectional view of the operational steps of an injector system in accordance with a third embodiment of the present invention; and Figures 4A and 4B show the injector system for a third embodiment in accordance with the present invention. A cross-sectional view of an exemplary drug container.
【主要元件符號說明】 11…藥物容納部 216，· ••支持元件 12…混合改良元件 220·· •注射器 13…堆桿 220’. ••注射器 15…桶狀部 221.· •藥物容納部 17…桿 22Γ. ••藥物容納部 18…針 222·· •混合改良元件 19…保護蓋 222，. ••混合改良元件 210···溶劑容器 223.. •堆桿 210’…溶劑容器 223，· ••堆桿 211···溶劑容納部 225" •桶狀部 211’…溶劑容納部 225，. ••桶狀部 213…堆桿 226.· •支持元件 213’…堆桿 226，· ••支持元件 214…注射器接收器 227- •桿 214’…注射器接收器 227’· •.桿 215…桶狀部 228.. .針 215’…桶狀部 228’. .•針 216.··支持元件 229- •保護蓋 17 200930426 229’…保護蓋 322…支持元件 230,…Luer 鎖 323…堆桿 231’…Luer鎖鞘 325…桶狀部 310…管 326…支持元件 311···藥物容納部 326’…固定元件 312···混合改良元件 327…桿 313…堆桿 328…針 314…注射器接收器 329…保護蓋 320…注射器 321…溶劑容納部[Description of main component symbols] 11: Drug accommodating portion 216, • Support member 12... Mixing and improving element 220···Syringe 13... Stacker 220'. ••Syringe 15...Barrel 221.· Drug accommodating unit 17...rod 22Γ.••drug accommodating portion 18...needle 222··•mixing improved element 19...protecting cover 222,.••mixing improved element 210···solvent container 223..•stack 210'...solvent container 223 •··••Plug bar 211···solvent accommodating part 225" • barrel part 211'...solvent accommodating part 225,. •• barrel part 213...stacking rod 226.·•Supporting element 213'...stacking rod 226, •••Support element 214...Syringe receiver 227- • Rod 214'...Syringe receiver 227'·• Rod 215...Barrel 228..Needle 215'...Barrel 228'..•Needle 216. · Supporting element 229- • Protective cover 17 200930426 229'... Protective cover 322... Supporting element 230, ... Luer Lock 323... Stacking rod 231'... Luer lock sheath 325... Barrel 310... Tube 326... Supporting element 311·· - Drug accommodating portion 326'...fixing member 312···mixing Liang lever member 327 ... 313 ... 328 ... rods stacking syringe needle receiver 314 ... 329 ... 320 ... cover 321 ... syringe receiving portion solvents