M287680 八、新型說明： 【新型所屬之技術領域】 本創作是有關於麵充填之分注裝置改良結構，特別是指一種自動排除藥劑 瓶内壓力、避免内部藥劑受外界污染之充填針頭結構。 【先前技術】 習見注射藥劑瓶生產時之充填分注裝置結構，乃如第丄圖所示，其係於 • 100層流空氣之合格環境下，由該灌注裝置3將無熱原容器工中儲存之已調^ .藥劑溶液’經由（耐酸驗）輸送管線2通過-過渡膜4(0.22_)，利用該過滤 .膜4濾除微粒及細菌後，經由一分注針5 〇通過橡皮塞6丄後，將藥劑溶液； /主至一無菌瓶6中，以形成藥物注射劑，而於分注作業之同時，需另以一通氣 ^貫穿該橡皮塞6 1，以適當讎祕止域瓶6_力增加；另有將= 溶《接由分注針5 〇分注至玻璃空瓶中，再予以封瓶並經過高壓滅菌後，形 鲁成，物注射劑。然而，上述以通氣針7連通無菌瓶6(或玻璃空瓶之開口） 内稍外界之結構，亦開啟藥劑溶液受污染之機會，若無法有效控制操作場合 保持無菌之環境’則該注入於該無菌瓶6内部之藥劑將難以避免遭受污染。 有鐘於習見注射藥劑瓶之充填分注方式及其相關結構有上述之缺點，創作 人乃針對該些缺點研究改進之道，終於有本創作產生。 【新型内容】 層济ϋ作旨在提供一種藥劑充填之分注裝置改良結構，其主要係於 ㈣叫之合格環境下設置一儲存藥劑溶液之無熱原容器，並以一輸送管線銜 5 M287680 接該無熱原容器至一過濾膜，而於該輸送管線中段設有一灌注裝置，利用該灌 注裝置抽唧無熱原容器内之藥劑溶液並輸送通過該過濾膜，由過濾膜濾除微粒 及細菌後，送至一細管狀且穿刺無菌瓶口橡皮塞之分注針，於該分注針外周緣 中段部位設有一沿轴向設置之凹槽道，使該橡皮塞彈性包覆於分注針周緣時， 會於該凹槽道部位形成一擠迫封閉部位，以便於排出無菌瓶内多餘之空氣壓 力，藉以增進藥劑充填過程的順暢，並確保藥劑不受外界污染，此為本創作之 主要目的。 依本創作之此種藥劑充填之分注裝置改良結構，其可有效阻絕一般外界環 境對藥劑瓶内之污染，故而，可降低對環境設備之嚴苛要求、適當節省投資及 生產成本，此為本創作之另一目的。 【實施方式】 本創作之詳細構造、顧原理、個與功效，則參照下列依關所作之說明即 可得到完全的瞭解。 如第1圖所示’其為習見注射藥劑瓶之充填分注裝置，其主要構成以及其 缺失，已如前所述，此處不再重複敘述。 第2圖係本創作之充填分注裝置結構示意圖，由其參照第3、4圖之分注 針構造示意圖及其橫斷面剖視圖，可以很_地看出，本創作相關充填裝置之 整體結構主要係於—Class⑽層流空氣之合格環境下，設置包括：域原容 器1、輸送管線2、灌注裝置3、過_4及分注針5等部份，其中該純原 Μ 1經由-㈤酸驗）輸送管線2銜接至_灌注裝置3，再經由_過渡膜4 銜接至該分注針5辦橡皮塞6 i而可伸人域瓶6内。 M287680 - 上述分注針5係呈一細管狀，其於外周緣中段部位設有一沿軸向設置之凹 槽道5 1 ’使该分注針5刺穿橡皮塞6 而伸入無菌瓶6内之時，該橡皮塞6 1可緊密包覆於該分注針5周緣，形成_氣密狀態，並使該橡皮塞6丄於凹槽 道51部位形成一強度較差之擠迫封閉部位6 2。 當灌注褒置3抽哪該藥劑溶液輸送通過該猶膜4，利用該過遽膜4以 0.22卵之細微孔域除微粒及_後，由該分注針5將細溶液分注至無菌 瓶6中’此時’無菌瓶6内壓力逐漸增加，部份空氣會由内推抵該擠迫封閉部 _位62外翻變形’以排出無菌瓶6内部多餘之空氣並釋放壓力，而可達到壓力平 .衡狀態，軌，彻無_6崎外_，咖雜細充填過程 穎性及進步性 惟以上所述者，僅為本_之—健實施例㈣ 施之細。S卩驗摘作冑 ”_雜林創作實 利範圍所涵蓋。W幽作之均等變化與修飾，皆為本創作專 M287680 【圖式簡單說明】 第1圖係習見注射藥劑瓶充填分注裝置結構示意圖。 第2圖係本創作之充填分注裝置結構示意圖。 第3圖係本創作之分注針構造示意圖。 第4圖係本創作之分注針橫斷面剖視圖。 【主要元件符號說明】 φ無熱原容器1 輸送管線2 灌注裝置3 過濾膜4 分注針5、50 凹槽道51 無菌瓶6 •橡皮塞61 擠迫封閉部位62 通氣針7M287680 VIII. New description: [New technical field] This creation is an improved structure of the dispensing device for surface filling, especially a filling needle structure that automatically removes the pressure inside the bottle and avoids contamination of the internal agent. [Prior Art] The structure of the filling and dispensing device during the production of the injection bottle is as shown in the figure, which is in the qualified environment of • 100 layers of air, and the perfusion device 3 will be used in the pyrogen-free container. The stored solution is passed through the (transacid-resistant) transfer line 2 through the -transition membrane 4 (0.22_), and the membrane 4 is used to filter out the particles and bacteria, and then through a dispensing needle 5 through the rubber stopper After 6 ,, the drug solution; / main to a sterile bottle 6 to form a drug injection, while at the same time as the dispensing operation, a further ventilation through the rubber stopper 6-1 to properly seal the bottle 6_ force increased; another will be dissolved "distributed by the dispensing needle 5 〇 into the glass empty bottle, and then sealed and autoclaved, shaped Lucheng, injection. However, the above-mentioned structure in which the venting needle 7 communicates with the sterile bottle 6 (or the opening of the glass empty bottle) also opens the opportunity for contamination of the chemical solution, and if it is unable to effectively control the environment in which the operation is maintained, the injection is performed. It is difficult to avoid contamination of the medicament inside the sterile bottle 6. There are some shortcomings in the filling and dispensing method of Zhong Yu's injection drug bottles and related structures. The creators have researched and improved the shortcomings of these shortcomings, and finally have this creation. [New content] The layered product is designed to provide a chemical filling device with improved structure, which is mainly provided in (4) a qualified environment to set up a pyrogen-free container for storing the drug solution, and a transfer line 5 M287680 Connecting the pyrogen-free container to a filter membrane, and providing a filling device in the middle of the transfer line, using the potting device to pump the chemical solution in the pyrogen-free container and transport it through the filter membrane, filtering the particles and filtering the membrane After the bacteria, the needle is sent to a thin tubular needle that penetrates the rubber stopper of the sterile bottle mouth, and an axially disposed groove is arranged in the middle portion of the outer circumference of the dispensing needle, so that the rubber stopper is elastically coated on the dispensing. At the periphery of the needle, an overcrowding portion is formed at the groove portion to facilitate the discharge of excess air pressure in the sterile bottle, thereby improving the smoothness of the filling process of the medicament and ensuring that the medicament is free from external pollution. the main purpose. The improved structure of the dispensing device according to the present invention can effectively prevent the pollution of the pharmaceutical bottle in the general external environment, thereby reducing the stringent requirements on environmental equipment, appropriately saving investment and production cost. Another purpose of this creation. [Embodiment] The detailed structure, principle, function and function of this creation can be fully understood by referring to the following instructions. As shown in Fig. 1, it is a filling and dispensing device for the injection bottle, and its main constitution and its absence are as described above, and will not be repeated here. Fig. 2 is a schematic view showing the structure of the filling and dispensing device of the present invention. Referring to the schematic diagram of the dispensing needle of the third and fourth drawings and the cross-sectional view thereof, it can be seen that the overall structure of the filling device of the present creation is Mainly in the qualified environment of Class(10) laminar air, the setting includes: domain original container 1, delivery line 2, perfusion device 3, over_4 and dispensing needle 5, etc., wherein the pure original Μ 1 via - (5) The acid pipeline) is connected to the _ priming device 3, and is connected to the dispensing needle 5 via the _transition membrane 4 to carry the rubber stopper 6 i and extend into the human bottle 6 . M287680 - The above-mentioned dispensing needle 5 is in the form of a thin tube, and is provided with an axially disposed groove 5 1 ' at the middle portion of the outer circumference so that the dispensing needle 5 pierces the rubber stopper 6 and protrudes into the sterile bottle 6 At this time, the rubber stopper 6 1 can be tightly wrapped around the circumference of the dispensing needle 5 to form an airtight state, and the rubber stopper 6 is placed on the grooved path 51 to form a weakly pressed and closed portion 6 2 . . When the perfusion device 3 is pumped through the membrane 4, the microcapsules are used to remove the microparticles and the microcapsules of the 0.22 egg, and then the fine solution is dispensed into the sterilized by the dispensing needle 5. In the bottle 6, the pressure in the aseptic bottle 6 is gradually increased, and some of the air will be pushed into the squeezed closure _ position 62 to deform outwards to discharge excess air inside the sterile bottle 6 and release the pressure. To achieve the pressure level, the balance state, the track, the _6 崎 outside the _, the groceries filling process and the progress of the above, only the above-mentioned - health example (four).卩 摘 摘 摘 _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Fig. 2 is a schematic view showing the structure of the filling and dispensing device of the present invention. Fig. 3 is a schematic view showing the structure of the dispensing needle of the present invention. Fig. 4 is a cross-sectional view of the cross section of the dispensing needle of the present creation. φ pyrogen-free container 1 transfer line 2 perfusion device 3 filter membrane 4 dispensing needle 5, 50 groove channel 51 sterile bottle 6 • rubber stopper 61 forced closure 62 ventilation needle 7