201029678 六、發明說明： 【發明所屬之技術領域】 本發明係關於-種液態製劑之調配方法，尤指蔣 殊乾瓶内高劑量之樣π他士彳 0種將 门削置又樣快速方便地稀釋於— -所需液態製劑之方法。 稀釋液而製传 【先前技術】 ::保=如病毒疫苗等製劑之活性，現有技 ❹ 7東:，。__叫之技術將此等製劑製 =::似保存時間。在疫苗注射前，需先將來乾劑 良之製劑復溶於合適的稀釋 以墓” 週的稀釋液u如符合生理條件之緩衝液 液)以得到一液態製劑’以供注射於人類或動物。 射態製劑的配製係以如下列方式進行：以無菌注 稀釋液瓶内抽取適當量稀釋液後，快速注射入;東乾 Μ β ί由推拉庄射筒之活塞令稀釋液於注射筒與束乾瓶之 ’以令泉乾瓶内之經;東乾之製劑樣品與稀釋液均句 混合’再依據指示劑量注射入施打對象。因此此種配製方 :除了凍乾瓶外’是以注射筒作為混合及施打的主要元 件0 專統束乾劑型之製劑，特別是疫苗製劑，因生產製程 :限制以及凍乾技術的瓶頸’使得單一凍乾劑型之製劑包 :的：量有所限制’隨著生產疫苗之製程與殊乾技術的突 ^ :凍乾劑型之製劑包裝已經可以容納超高劑量之製 “、、而目刚將凍乾劑型之製劑配製成液態製劑卻仍然維 制，有的配製方法’即是將稀釋液與;東乾瓶内之經束乾之 樣品如前述步驟均句混合後，再將混合液注入含稀释 201029678 液之稀釋液瓶内，再依據指示劑量注射入施打對象。 、基於上述可見，舊有由凍乾製劑調配成液態製劑之方 法因為需要透過注射筒内之容置空間，進行稀釋液的抽 ‘放，因此無法擴充至太大的體積，如欲施打於以萬計數之 :動物時，必須反覆舊有的配製方法。此外，於舊有的配製 方法的過程中，需要父替的將注射筒插入束乾瓶與稀釋液 瓶數次，其會增加污染之機率。再者，當洗乾瓶内之束乾 樣品之劑量較高，而僅能以注射筒取少量稀釋液進行混合 Φ 的情況下，恐有混合不均的現象。 【發明内容】 本發明係針對現有技術之前述缺失及需求，經過反覆 試驗而發展出一可將稀釋液瓶與凍乾瓶直接結合使用，透 過無需額外抽拔注射筒即可將凍乾瓶内樣品與稀釋液瓶内 稀釋液充分混合之方法，由於其所需使用的元件及步驟簡 便，因此可達到經濟且快速之目的。 因此，本發明係提供一種由高劑量凍乾製劑調配液態 製劑之方法，其包括下列步驟： ⑴提供一;東乾瓶具有一樣品槽可供容置一樣品，—稀 釋液瓶具有一儲液槽可供容置一稀釋液，一注射筒具有一 可壓縮或擴張之中繼槽； (丨丨）令邊中繼槽、儲液槽以及樣品槽相連通； (11 i)使稀釋液趨向於離開儲液槽内之狀態； (iv) 接而令中繼槽壓縮，而使稀釋液進入樣品槽與樣 品相混合，藉以得到一混合液； (v) 使遇合液趨向於趨向離開樣品槽内之狀態；以及 201029678 ⑽接而令中繼槽壓縮，而使得混合液進入餘液槽内， 而令混合液仙液槽内其餘稀釋液充分混合， 之配製。 几取像。口 依據本發明，該樣品係為來乾劑型 列任何-者:化合物，諸如翠一有機化合物，„東:之: ，醫樂組成物，以及生物製劑，》包含諸如蛋白質、核酸 ^依據本發明，該稀釋液可以為任何適合生理環境可供 參打至人或動物體内之溶液，如生理食鹽水等。 依據本發明，所述的令重力使稀釋液趨向樣品槽内流 動具體而言，係指令;東乾航位於稀釋液瓶下方。 依據本發明，令該中繼槽與儲液槽相連通之步驟包括 使用:採血針或三通閥連接有針頭將其等之兩端分別插入 東乾瓶與稀釋液瓶内，而令中繼槽與儲液槽相連通。 依據本發明，令中繼槽壓縮/擴張係可藉由推拉注射筒 _ 之活塞，或其他可能類似的技術手段而達成。 綜上所述，本發明由高劑量凍乾製劑調配液態製劑之 方法可運用於稀釋具有以百、千劑量單位之超高劑量的生 製劑之配製，諸如供用於豬痕防治之疫苗接種，可供用 施打於以萬計數的豬隻，由於每瓶裝劑量可放大十倍以上， 不僅可節省凍乾疫苗之製造成本，且每批施打劑量單位數 (亦即可施打的豬隻數量）亦可放大十倍以上，於製程、檢 驗運輪、包裝耗材以及施打人力、設備各方面之成本均 可因而降低。 【實施方式】 201029678 本發日月+ .. 乃之一種由高劑量凍乾製劑調配液態製劑之方 法，其係包括下列步驟：_ (丨）提供—凍乾瓶具有一樣品槽可供容置一樣品，一稀 釋液瓶具有—儲液槽可供容置一稀釋液，一注射筒具有一 可壓縮或擴張之中繼槽； ⑴）令該中繼槽、儲液槽以及樣品槽相連通； (Mi)使稀釋液趨向於離開儲液槽内之狀態； (lv)接而令中繼槽壓縮，而使稀釋液進入樣品槽與樣 •品相混合，藉以得到一混合液； (V)使混合液趨向於趨向離開樣品槽内之狀態；以及 (vi)接而令中繼槽壓縮，而使得混合液進入儲液槽内， 而令混合液與儲液槽内其餘稀釋液充分混合，以完成樣品 之配製。 °° 在本發明之第一較佳實施例中，步驟（Mi)使稀釋液趨向 於離開儲液槽内之狀態包括藉由重力使稀釋液趨向樣品槽 内流動。 9 在本發明之第二較佳實施例中，前述本發明之方法進 一步包括：令樣品槽係與環境大氣相連通，而樣品槽與環 境大氣之間設有一過濾膜。 、 在本發明之第三較佳實施例，步驟（in)使稀釋液趨向 於離開儲液槽内之狀態係包括：使中繼槽與樣品槽不連 通；以及令該中繼槽擴充，而使一部分稀釋液進入中繼槽· 而 胃* 步驟（v)該使混合液趨向於趨向離開樣品槽内之狀熊係 包括：使中繼槽與儲液槽不連通；以及令中繼槽擴張，^ 6 201029678 令混合液進入中繼槽 在本發明之第四較佳實施例中L步驟（iii)使稀釋液趨 向於離開儲液槽内之狀態係包括：使中繼槽與樣品槽不連 通，而儲液槽仍與樣品槽相連通；而 步驟（v)使混合液趨向於趨向離開樣品槽内之狀態係包 括.使中繼槽與儲液槽不連通，而儲液槽仍與樣品槽相連 通 在本發明之第五較佳實施例中，步驟使稀釋液趨 ® 向於離開儲液槽内之狀態係包括：令該中繼槽僅與儲液槽 相通，而使中繼槽與樣品槽之間不直接連通；而 步驟（vi)該令中繼槽壓縮’而使得混合液進入健液槽 内係置換成：令中繼槽擴張’而使得混合液回流至儲液槽 内’而令混合液與儲液槽内其餘稀釋液充分混合，以完成 樣品之配製。 本發明將由下列的實施例做為進一步說明，這些實施 例並不限制本發明前面所揭示的内容。熟習本發明之技藝 參 者，可以做些許之改良與修飾，但不脫離本發明之範_。 於下述實施例中，所使用的元件裝置如下： 凍乾瓶，其如此技術領域所知者，其主要具有一玻壤 槪身、一丁基橡膠瓶塞以及封裝固定該封蓋之密封圈，其 内具有一樣品槽（1)可通谷置一樣品’此處所使用的樣品為 豬瘟病毒疫苗。 稀釋液瓶，如此技術領域所知者，亦具有一玻璃瓶身、 一橡膠封蓋以及封裝固定該封蓋之密封圈，其内具有一儲 液槽（2)可供容置稀釋液’此處所使用的樣品為生理缓衝 201029678 液0 _三通閥，此處所使用的三通閥係如此技術領域中所知 者，其具有一第一端（31)、一第二端（32)以及一第三端（33) 而三通閥中形成一可選擇性地調整使其中兩端相連通，於 下面實施例中’二通閥三端分別裝設有適當可穿刺；東乾瓶 與稀釋液瓶頂端之橡膠材料封蓋材料之二針頭以及該注射 筒，而形成-可選擇性地調整使其中兩端相連通之控制流 路（3)。201029678 VI. Description of the invention: [Technical field to which the invention pertains] The present invention relates to a method for formulating a liquid preparation, in particular, a high-dose sample of JIANG shanggan bottle, which is a quick and convenient method for cutting a door. Diluted to the method of liquid preparation required. Dilution and transfer [Prior Art] :: Guarantee = Activity of preparations such as viral vaccines, prior art ❹ 7 East:,. __ called technology to make these preparations =:: like storage time. Before the vaccination, it is necessary to re-dissolve the preparation of the dry preparation in a suitable dilution to the tomb "weekly dilution solution u such as a physiologically acceptable buffer solution" to obtain a liquid preparation for injection into humans or animals. The preparation of the preparation is carried out in the following manner: after extracting the appropriate amount of the diluent in the sterile injection diluent bottle, and quickly injecting it; the Donggan Μ β ί is pushed by the piston of the cylinder to make the dilution in the syringe and the bundle The bottle's use in the dried bottle of the spring; the sample of Donggan's preparation is mixed with the diluent, and then injected into the target according to the indicated dose. Therefore, the formulater: except the lyophilized bottle, is the syringe As the main component of mixing and application, the preparation of the special dry-drying type, especially the vaccine preparation, due to the production process: the limitation and the bottleneck of the freeze-drying technology, the preparation package of the single lyophilized dosage form: the amount is limited With the process of producing vaccines and the breakthrough of the special technology: the formulation of the lyophilized dosage form can already accommodate the ultra-high-dose system, and the preparation of the lyophilized dosage form is formulated into a liquid preparation, but it is still maintained. Have The preparation method is to mix the diluted solution with the dried sample in the Donggan bottle, and then mix the mixture into the diluent bottle containing the diluted 201029678 liquid, and then inject the application according to the indicated dosage. Hit the object. Based on the above, it can be seen that the method of formulating a lyophilized preparation into a liquid preparation requires that the diluent is pumped through the accommodating space in the syringe, so that it cannot be expanded to a too large volume. Counting in 10,000: When animals are used, the old method of preparation must be repeated. In addition, in the process of the old preparation method, the syringe is required to be inserted into the bundle dry bottle and the diluent bottle several times, which increases the probability of contamination. Further, when the dose of the dried sample in the bottle is high, and only a small amount of the diluent can be mixed in the syringe, Φ may cause uneven mixing. SUMMARY OF THE INVENTION The present invention is directed to the aforementioned shortcomings and needs of the prior art, and has been developed through repeated tests to directly combine a diluent bottle with a lyophilized bottle, and to freeze the bottle by removing the syringe without additional extraction. The method of thoroughly mixing the sample with the diluent in the diluent bottle can achieve economical and rapid effects because of the components and steps required for the use. Therefore, the present invention provides a method for formulating a liquid preparation from a high-dose lyophilized preparation, which comprises the following steps: (1) providing one; the Donggan bottle has a sample tank for accommodating a sample, and the diluent bottle has a stock solution The tank is adapted to receive a diluent, and a syringe has a relay tank that can be compressed or expanded; (丨丨) the side relay tank, the liquid storage tank and the sample tank are connected; (11 i) the diluent is inclined (iv) in turn, the relay tank is compressed, and the diluent is introduced into the sample tank and mixed with the sample to obtain a mixed liquid; (v) the solution is inclined to tend to leave the sample tank The state of the interior; and 201029678 (10), in turn, the relay tank is compressed, so that the mixed liquid enters the remaining liquid tank, and the remaining dilution liquid in the mixed liquid tank is thoroughly mixed. Take a few images. According to the present invention, the sample is a dry dosage form of any one of: a compound such as a green organic compound, a „东:之:, a medical composition, and a biological preparation, ―containing a protein, a nucleic acid, according to the present invention. The diluent may be any solution suitable for physiological environment to be incorporated into a human or animal body, such as physiological saline solution, etc. According to the present invention, the gravity causes the diluent to flow into the sample tank, specifically According to the present invention, the step of connecting the relay tank to the liquid storage tank includes: using a blood collection needle or a three-way valve connected with a needle to insert both ends thereof into the east The dry bottle and the diluent bottle are connected to each other, and the relay tank is connected to the liquid storage tank. According to the present invention, the relay groove compression/expansion can be made by pushing and pulling the syringe, or other similar technical means. In summary, the method of the present invention for formulating a liquid preparation from a high-dose lyophilized preparation can be used for diluting a preparation having a super-high dose of a hundred-dollar unit, such as for use in pig mark prevention. The vaccination of the treatment can be used to tens of thousands of pigs. Because each bottle can be magnified ten times or more, it can not only save the manufacturing cost of the lyophilized vaccine, but also the number of units per batch. The number of pigs can also be magnified by more than ten times, and the cost of the process, the inspection wheel, the packaging consumables, and the manpower and equipment can be reduced. [Embodiment] 201029678 The date of the month + .. A method for formulating a liquid preparation by a high-dose lyophilized preparation, comprising the following steps: _ (丨) providing - a lyophilized bottle having a sample tank for accommodating a sample, and a diluent bottle having a liquid storage tank Having a diluent, a syringe has a relay tank that can be compressed or expanded; (1)) the relay tank, the liquid storage tank and the sample tank are connected; (Mi) the diluent tends to leave the liquid storage tank The state of (lv) is followed by compression of the relay tank, and the diluent is introduced into the sample tank to mix with the sample to obtain a mixed liquid; (V) the mixture tends to tend to leave the sample tank; And (vi) relaying Compressing, so that the mixed liquid enters the liquid storage tank, and the mixed liquid is thoroughly mixed with the remaining dilution liquid in the liquid storage tank to complete the preparation of the sample. °° In the first preferred embodiment of the present invention, the step (Mi) The state in which the diluent tends to leave the reservoir includes the flow of the diluent toward the sample tank by gravity. 9 In a second preferred embodiment of the present invention, the aforementioned method of the present invention further comprises: sampling the sample tank The membrane is connected to the atmosphere of the environment, and a filter membrane is disposed between the sample tank and the ambient atmosphere. In the third preferred embodiment of the present invention, the step (in) of causing the diluent to move away from the reservoir includes : disabling the relay tank from the sample tank; and expanding the relay tank to allow a portion of the diluent to enter the relay tank. And the stomach* step (v) tends to cause the mixture to move away from the sample tank The method includes: disabling the relay tank from the liquid storage tank; and expanding the relay tank, ^ 6 201029678, allowing the mixed liquid to enter the relay tank. In the fourth preferred embodiment of the present invention, the step (iii) is to make the diluent Tend to leave the liquid The internal state includes: the relay tank is not in communication with the sample tank, and the liquid storage tank is still in communication with the sample tank; and the step (v) causes the mixed liquid to tend to move away from the sample tank. The tank is not in communication with the liquid storage tank, and the liquid storage tank is still in communication with the sample tank. In a fifth preferred embodiment of the present invention, the step of causing the diluent to move away from the liquid storage tank includes: The relay tank is only in communication with the liquid storage tank, and the relay tank and the sample tank are not directly connected; and the step (vi) is to compress the relay tank to make the mixed liquid enter the nutrient tank and replace it with: The relay tank expands 'and the mixture is returned to the liquid storage tank', and the mixed liquid is thoroughly mixed with the remaining diluent in the liquid storage tank to complete the preparation of the sample. The invention is further illustrated by the following examples, which are not intended to limit the invention. A person skilled in the art will be able to make some modifications and modifications without departing from the scope of the invention. In the following examples, the component devices used are as follows: A lyophilized bottle, which is known in the art, has a glassy body, a butyl rubber stopper, and a sealing ring that encloses the closure. There is a sample tank (1) in which a sample can be placed in the valley. The sample used here is a swine fever virus vaccine. The diluent bottle, as known in the art, also has a glass bottle body, a rubber cover and a sealing ring enclosing the cover, which has a liquid storage tank (2) for accommodating the diluent. The sample used in the space is a physiological buffer 201029678 liquid 0 _ three-way valve, and the three-way valve used herein is known in the art and has a first end (31), a second end (32), and a third end (33) and a three-way valve formed selectively adjustable to connect the two ends thereof. In the following embodiments, the two ends of the two-way valve are respectively provided with appropriate puncture; the east dry bottle and the diluted The two needles of the rubber material capping material at the top of the liquid bottle and the syringe are formed to selectively adjust the control flow path (3) for connecting the two ends thereof.
注射筒，其具有一中繼槽（4)，該中繼槽（4)可藉由活 塞予以壓縮或擴張。 採血針，其係為二方連接管並且具有一令其兩端相連 通之通道（5)。 三方連接管，其具有一令其三端相連通之三方流路 (6) 〇 具有過濾膜之連通管，所使用的濾膜孔徑大小可以為 但不限於0.22 μηι或者0.45 μΓη。 〃 在本發明之第-較佳實施例中，如第_Α圖所示，使 三方連接管之三方流路（6)分別與凍乾瓶之樣品槽（1)、稀 釋液瓶之儲液槽（2)以及注射筒之中繼槽（4)=者相連、雨 之後如第—Β圖所示’令凍乾瓶位於稀釋液瓶下方，：用 注射筒打入氣體進入來乾飯内，目氣體相對稀釋液較輕， 會進入儲液槽（2)内令儲液槽（2)内稀釋液流入凍乾瓶，並 以搖晃凍乾瓶、稀釋液瓶、裝設有針頭 ^ 、 ,二通閥與三通問 相接之注射筒整體之方式或利用注射筒 门不斷地來回抽放之 混5方式，以令樣品與稀釋液充分混合 取 /¾合液，挺 201029678 而如第一 c圖所示，反轉束乾湘為 符果钇瓶及稀釋液瓶，令凍乾瓶在 上’利'用_.注射清-打入氣體，使翁《I*、也、 1文乳體進入樣品槽（1)内令樣品 槽（1)内混合液流入儲液槽（2)内，S剎田L L| ’ η 丹利用如上所述之混合 方式將混合液與稀釋液瓶内之盆餘铩經右*八、a人 ，、你稀釋液充分混合，以完 成樣品之配製。The syringe has a relay slot (4) which can be compressed or expanded by a piston. A lancet, which is a two-way connecting tube and has a passage (5) that connects the ends thereof. The three-way connecting pipe has a three-way flow path (6) for connecting the three ends thereof, and a connecting pipe having a filter membrane, and the filter pore size used may be, but not limited to, 0.22 μηι or 0.45 μΓη. 〃 In the first preferred embodiment of the present invention, as shown in the figure _, the three-way flow path (6) of the three-way connecting tube and the sample tank (1) of the lyophilized bottle, and the stock solution of the diluent bottle are respectively The trough (2) and the relay tank (4) of the syringe are connected, and after the rain, as shown in the figure-Β, the lyophilized bottle is placed under the diluent bottle, and the gas is injected into the dry rice by the syringe. The gas is relatively light relative to the diluent, and will enter the liquid storage tank (2) to allow the dilution liquid in the liquid storage tank (2) to flow into the lyophilized bottle, and shake the lyophilized bottle, the diluent bottle, and the needle ^, The two-way valve and the three-way contact with the syringe as a whole or the use of the syringe door to continuously pull back and forth mixed 5 way, so that the sample and the diluent are thoroughly mixed to take / 3⁄4 liquid, quite 201029678 and as the first In the picture c, reverse the bunch of dried Xiang into a bottle of fruit and a bottle of diluent, so that the lyophilized bottle is used in the 'L'. _. Injection clear - into the gas, so that Weng "I *, also, 1 milk The body enters the sample tank (1) and the mixed liquid in the sample tank (1) flows into the liquid storage tank (2), and the S-field LL|' η Dan uses the mixing method as described above to mix the liquid. Dilution bottle of pots spear through the right * of more than eight, a person ,, you dilution sufficiently mixed to complete the preparation of the sample.
在本發明之第二較佳實施例中，如第二八圖所示，使 三方連接管之三方流路⑹與康乾瓶之樣品槽⑴與稀釋液 瓶之儲液槽（2)以及注射筒之中繼槽（4)三者相連通，另外 再使用一具有過遽膜於其管路（7)之連通管，令束乾瓶之樣 品槽（1)與環境大氣E相通，之後如第二B圖所示，令凍 乾瓶位於稀釋液瓶下方，利用注射筒打入氣體，使氣體一 部分進入儲液槽（2)内令儲液槽（2)内稀釋液流入凍乾瓶或 進入束乾舨之樣品槽⑴内而令—部分由該具錢膜之連通 管離開排入環境大氣E中，並以搖晃來乾瓶、稀釋液瓶、 該具有濾膜之連通管、裝設有針頭之三通閥以及與三通閥 相接之注射筒整體之方式或利用注射筒不斷地來回抽放之 此合方式，以令樣品與稀釋液充分混合形成一混合液，接 而如第二C圖所示，反轉凍乾瓶及稀釋液瓶，令凍乾瓶在 =m射筒打入氣體’使氣體一部分進入樣品槽⑴内 令樣品槽（1)内混合液流入儲液槽（2)内，令_部分藉由該 f =管排入環境大氣E中，再利用如上所述之混合方式將 混合液與稀釋液瓶内之其餘稀釋液充分混合，以完成樣品 之配製。 π 口口 八於本發明之第三較佳實施例中，如第三Α圖所示，首 先令一三通閥的第一端（31)與一注射筒相連接，而將三通 201029678 閥之第二端（32)與第三端（33)分別與㈣瓶之樣品槽以 及稀-釋液瓶之儲液槽（2)相料，以令該樣品槽⑴愈健液 可相連通。如第三Β圖所示，當控制流路（3)調整為 第-端（31)與第三端（3啦通時，利用注射筒抽氣方式將 一部分之稀释液由儲液槽（2)内抽入注射筒内；如第三c圖 所示，令控制流路（3)調整為第一端（31)與帛二端（叫相連 通，將注射筒内之稀釋液擠壓至隸瓶之樣品槽⑴， Φ 令稀释液與;東乾瓶内之樣品進行混合，以搖㈣乾瓶、稀 2液瓶、裝設有針頭之三通閥以及與三通閥相連接之注射 筒整體之方式或利用注射筒不斷地來回抽放之混合方式， 以令樣品與稀釋液充分混合形成一混合液，並如第三D圖 所示，回抽至注射筒之中繼槽（4)内，接而如第三e圖所示， 令控制流路（3)調整為第一端（31)與第三端（33)相連通，並 擠壓注射筒將該混合液送入儲液槽（2)内[亦即將中繼槽（4) 内之氣體擠壓至儲液槽（2)内】，再利用如上所述之混合方 式將混合液與稀釋液瓶内之其餘稀釋液充分混合，以完成 樣品之配製。 在本發明之第四較佳實施例中，如第四A圖所示，令 :三通閥的第一端（31)與一注射筒相連接，而令三通閥之 第二端（32)與第三端（33>分別與凍乾瓶之樣品槽（1)以及稀 釋液瓶之儲液槽（2)相連通，同時使用一採血針，將採血針 之兩端分別插入該凍乾瓶與稀釋液瓶之樣品槽（1)與儲液槽 (2)内，而採血針之進入儲液槽（2)的一端係直接與稀釋液 相接觸，藉由其通道（5)令該樣品槽〇 )與儲液槽（2)相連通。 當控制流路（3)調整為第一端（31)與第三端（33)連通時，如 201029678 第四B圖所示，利用注射筒將中繼槽⑷内之氣體打入儲液 槽⑵内，令儲液槽（2)上方空間之氣壓増加^令儲液槽（？） 内之稀釋液透過採血針之通道(5)進入東乾瓶之樣品槽 ⑴’此時令稀釋液與束乾瓶内之樣品進行混合，以搖晃束 乾瓶、稀釋液瓶、採血針、裝設有針頭之三通閥以及與三 通閥相接之注射筒琴體$古—，—、4, 扣·同登體之方式或利用注射筒不斷地來回抽 放’以令樣品與稀釋液充分混合形成—混合液，接而如第In a second preferred embodiment of the present invention, as shown in FIG. 8 , the three-way flow path of the three-way connecting pipe (6) and the sample tank (1) of the Kanggan bottle and the liquid storage tank (2) of the diluent bottle and the injection are provided. The relay groove (4) of the cylinder is connected, and a connecting pipe having a ruthenium film in the pipe (7) is used, so that the sample tank (1) of the bundle dry bottle communicates with the ambient atmosphere E, and then In the second B-picture, the lyophilized bottle is placed under the diluent bottle, and the gas is injected into the sump through the syringe, so that a part of the gas enters the sump (2), and the diluent in the sump (2) flows into the lyophilized bottle or Entering the sample tank (1) of the bundled stem and leaving it to the ambient atmosphere E, and drying the bottle, the diluent bottle, the connecting tube with the filter membrane, and the installation a three-way valve with a needle and a syringe connected to the three-way valve as a whole or a method of continuously pumping back and forth with the syringe to mix the sample and the diluent to form a mixed solution, and then As shown in Figure C, reverse the freeze-dried bottle and the diluent bottle, so that the freeze-dried bottle is in the gas of the =m injection cylinder. Part of the body enters the sample tank (1), and the mixed liquid in the sample tank (1) flows into the liquid storage tank (2), so that the _ portion is discharged into the ambient atmosphere E by the f = tube, and then the mixing method as described above is used. The mixture is thoroughly mixed with the remaining diluent in the diluent bottle to complete the preparation of the sample. π 口口八 In the third preferred embodiment of the present invention, as shown in the third drawing, first, the first end (31) of the three-way valve is connected to a syringe, and the three-way 201029678 valve is connected. The second end (32) and the third end (33) are respectively matched with the sample tank of the (four) bottle and the liquid storage tank (2) of the dilute-release bottle, so that the sample tank (1) can be connected to the nutrient solution. As shown in the third diagram, when the control flow path (3) is adjusted to the first end (31) and the third end (3, the pumping method is used to pump a part of the dilution liquid from the liquid storage tank (2). The inside is drawn into the syringe; as shown in the third c-picture, the control flow path (3) is adjusted so that the first end (31) and the second end of the crucible are connected, and the dilution liquid in the syringe is squeezed to The sample tank (1) of the bottle, Φ is used to mix the diluted solution with the sample in the Donggan bottle to shake (4) dry bottle, dilute 2 liquid bottle, three-way valve equipped with a needle and injection connected with the three-way valve The whole way of the tube or the mixing mode of the syringe is continuously pulled back and forth to mix the sample and the diluent to form a mixed liquid, and as shown in the third D figure, pump back to the relay tank of the syringe (4) And, as shown in the third e diagram, the control flow path (3) is adjusted so that the first end (31) communicates with the third end (33), and the syringe is squeezed to send the mixed liquid to the reservoir. In the liquid tank (2) [also press the gas in the relay tank (4) into the liquid storage tank (2)], and then use the mixing method as described above to mix the liquid in the mixture with the diluent bottle. The diluent is thoroughly mixed to complete the preparation of the sample. In the fourth preferred embodiment of the present invention, as shown in FIG. 4A, the first end (31) of the three-way valve is connected to a syringe. The second end (32) and the third end (33> of the three-way valve are respectively connected to the sample tank (1) of the lyophilized bottle and the liquid storage tank (2) of the diluent bottle, and a blood collection needle is used at the same time. Insert the two ends of the blood collection needle into the sample tank (1) and the liquid storage tank (2) of the lyophilized bottle and the diluent bottle, respectively, and the end of the blood collection needle entering the liquid storage tank (2) is directly connected with the diluted liquid phase. Contacting, the sample tank (5) is connected to the liquid storage tank (2) by its passage (5). When the control flow path (3) is adjusted so that the first end (31) is in communication with the third end (33), As shown in Figure 4B of 201029678, the gas in the relay tank (4) is driven into the liquid storage tank (2) by the syringe, so that the pressure in the space above the liquid storage tank (2) is increased in the liquid storage tank (?). The diluent passes through the channel of the blood collection needle (5) and enters the sample tank of the Donggan bottle (1)'. At this time, the dilution liquid is mixed with the sample in the bundle dry bottle to shake the dry bottle and the diluent bottle. a blood collection needle, a three-way valve equipped with a needle, and a syringe body connected to the three-way valve, the ancient body, the -, the 4, the buckle, the same as the body or the use of the syringe to continuously pull back and forth The sample is thoroughly mixed with the diluent to form a mixture, which is followed by
四C圖所不，令控制流路⑶調整為第-端（川與第二端（μ) 相連通’再利用注射筒將氣體打人;東乾瓶之樣品槽⑴内， 而令混合液由採A針之通道⑸回流至稀釋液瓶，再利用如 上所述H合方切混合液與稀釋液瓶内之其餘稀釋液充 分混合，以完成樣品之配製。 ，在本發明之第五較佳實施例中，如第五A圖所示，將 採血針之兩端分別插入該凍乾瓶與稀釋液瓶之樣品槽（1)與 儲液槽(2)内，而採血針之進入儲液槽(2)的一端係直接與 稀釋液相接觸，藉由其通道（5)令該樣品槽（1)與儲液槽（2) 相連通，將注射筒之針頭插入稀釋液瓶之儲液槽（2)内，令 中繼槽（4)與儲液槽（2)相連通，接而如第五B圖所示，利 用z主射筒將中繼槽⑷内之氣體打入儲液槽（2)内，令儲液 槽（2)上方空間之氣壓增加，而令儲液槽（2)内之稀釋液透 ic採金針之通道（5)進入殊乾瓶之樣品槽，此時令稀釋 液與凍乾瓶内之樣品進行混合，以搖晃凍乾瓶、稀釋液瓶、 才木也針以及與注射筒整體之方式或利用注射筒不斷地來回 抽放，以令樣品與稀釋液充分混合形成一混合液，接而如 第五c圖所不，利用注射筒回抽儲液槽（2)上方之空氣至注 11 201029678 射筒之中繼槽（4)内，連帶令凍乾瓶之樣品槽（1)内之混合 液回流至儲液槽（2)内再-利用—如上所..述之混合方式將混合 液與稀釋液瓶内之其餘稀釋液充分混合，以完成樣品之配 製。 根據本發明可作之不同修正及變化對於熟悉該項技術 者而5均顯然不會偏離本發明的範圍與精神。雖然本發明 已敘述特定的較佳具體事實，必須瞭解的 eIn the fourth C diagram, the control flow path (3) is adjusted to the first end (the Sichuan is connected to the second end (μ)', and the gas is beaten by the syringe; the sample tank (1) of the Donggan bottle is used, and the mixture is mixed. The sample is recirculated from the channel (5) of the A needle to the diluent bottle, and then mixed with the remaining dilution liquid in the diluent bottle by using the H-cutting mixture as described above to complete the preparation of the sample. In the fifth aspect of the present invention In a preferred embodiment, as shown in FIG. 5A, the two ends of the blood collection needle are respectively inserted into the sample tank (1) and the liquid storage tank (2) of the lyophilized bottle and the diluent bottle, and the blood collection needle is stored. One end of the liquid tank (2) is directly in contact with the diluted liquid phase, and the sample tank (1) is connected to the liquid storage tank (2) through the passage (5), and the needle of the injection cylinder is inserted into the storage of the diluent bottle. In the liquid tank (2), the relay tank (4) is connected to the liquid storage tank (2), and as shown in FIG. 5B, the gas in the relay tank (4) is driven into and stored by the z main shot. In the liquid tank (2), the air pressure in the space above the liquid storage tank (2) is increased, and the dilution liquid in the liquid storage tank (2) is passed through the passage of the ic gold picking needle (5) into the sample tank of the special dry bottle. Mix the dilution with the sample in the lyophilized bottle to shake the lyophilized bottle, the diluent bottle, the ampule, and continuously and repeatedly with the syringe or with the syringe to make the sample and the diluent Mix thoroughly to form a mixture, and then, as shown in Figure 5, use the syringe to pump back the air above the reservoir (2) to the relay tank (4) of the injection tank 2010 2010678, with lyophilization The mixture in the sample tank (1) of the bottle is returned to the liquid storage tank (2), and the mixture is thoroughly mixed with the remaining dilution liquid in the diluent bottle as described above to complete the sample. The various modifications and variations of the present invention are obvious to those skilled in the art without departing from the scope and spirit of the invention. Although the present invention has described certain preferred specific facts, it must be understood.
不當地限制於該等特定具體事實上。事實上，在實施本: 明之已述模式方面，對於熟f該項技術者而言顯而易知之 不同修正亦被涵蓋於下列申請專利範圍之内。 【圖式簡單說明】 一第—圖係本發明之第一較佳實施例之示意圖，其中第 一 A圖為連接關係、圖，巾第_B圖至第—c圖係為操作示 第二圖係本發明之第二較佳實施例之示意圖，其中第 A圖為連接關係圖，而第二已圖至第二C圖係為操作示 圖0 第圖係本發明之第三較佳實施例之示意、圖，其中第 =圖為連接關係圖’而第^ B圖至第三E圖係為操作示 四^四圖係本發明之第四較佳實施例之示意圖，其， 意圖圖為連接關係圖’而第^圖至第四〇圖係為操彳 第五圖係本發 五A圖為連接關係 明之第五較佳實施例之示意圖，其中第 圖，而第五B圖至第五C圖係為操作示 12 201029678 意圖。 【主要元件象號說明】 (1)樣品槽 (3) 控制流路 (32)第二端 (4) 中繼槽 (6)三方流路 (2)儲液槽 (31)第一端 (33)第三端 (5)通道 (7)管路Unduly limited to these specific specific facts. In fact, in the implementation of this: the mode of the description, the different amendments that are obvious to those skilled in the art are also covered by the following patent applications. BRIEF DESCRIPTION OF THE DRAWINGS A first embodiment of the present invention is a schematic diagram of a first preferred embodiment of the present invention, wherein the first A is a connection relationship, and the figure is a second operation. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 2 is a schematic view of a second preferred embodiment of the present invention, wherein FIG. A is a connection diagram, and a second to second C diagram is an operation diagram. FIG. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a connection diagram ′ and FIG. 4 to FIG. 3E are diagrams showing an operation of the fourth preferred embodiment of the present invention. For the connection diagram 'the second to fourth diagrams are the fifth diagram, the fifth diagram is the fifth preferred embodiment of the connection relationship, wherein the figure is shown, and the fifth picture is The fifth C diagram is intended to operate 12 201029678. [Main component image description] (1) Sample tank (3) Control flow path (32) Second end (4) Relay tank (6) Tripartite flow path (2) First end of liquid storage tank (31) (33 ) third end (5) channel (7) pipeline
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