TW527194B - Replenisher and components for hemofiltration and method for producing the same - Google Patents

Replenisher and components for hemofiltration and method for producing the same Download PDF

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TW527194B
TW527194B TW87119909A TW87119909A TW527194B TW 527194 B TW527194 B TW 527194B TW 87119909 A TW87119909 A TW 87119909A TW 87119909 A TW87119909 A TW 87119909A TW 527194 B TW527194 B TW 527194B
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patent application
scope
supplement
item
liquid
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TW87119909A
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Chinese (zh)
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Li-Ching Lin
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Sintong Chemical Ind Co Ltd
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Abstract

The present invention relates to a replenisher and a components for hemofiltration, in which the replenisher comprises NaCl, MgCl2.6H2O, CaCl2.2H2O, and NaHCO3. The present invention also relates to a method for producing a replenisher for hemofiltration.

Description

527194 A7 B7 五、發明説明(1 ) .... 發明範疇 二, 本發明係關於血液過濾術之補充液與組件灰'其1製法。 發明背景 當腎功能逐漸喪失產生尿毒症狀之後,人類企圖尋找各 式各樣的方法以取代原本正常功能的腎臟,藉以維持生 命。在這些替代方法之中,使用最多的就是透析治療,包 括血液透析與腹膜透析。但透析治療的原理與腎臟廓清廢 物之方式並不相同。為能以更類似於人體腎臟排泄功能之 方式清除物,血液過遽術(hemofiltration)於焉產生。 血液過攄術是利用"對流傳導(convective transport) ”方式清除 廢物,其與採用擴散原理之傳統血液透析不盡相同。所謂 對流傳導是利用Starling定律,藉著體液排出時,將溶解於 其中之溶質一起帶出體外,血液過濾術就是利用這種方式 來清除廢物。除對流傳導外,還要將不含尿毒素的補充液 輸入體内,藉以維持體液及電解質之完整性,並且稀釋體 内殘餘毒素之濃度藉以達到降低濃度·的目的。所以在理論 上,血液過濾術的原理與腎絲球之功能相當類似。 連續性動靜旅:血液過濾、術(continuous arteriovenous hemofiltration, CAVH)與血液過濾術相同是採用對流傳導之原理來排除廢 物,再填充適量之補充液加以稀釋。不同的是,前者只利 用動靜之壓力差,而後者則是利用超過濾幫浦。所以, CAVH可視為”慢速之血液過濾術”。由於利用動靜脈壓 差,沒有幫浦作用所產生的負壓現象,所以不需要各種監 視器及機器之設備。·既然不需要機器及專業人員在旁邊監 -4 一 本紙張尺度適用中國國家標準(CNS ) A4規格(210X297公釐) (請先閲讀背面之注意事 IK~ 裝-- 寫本K ) 訂 經濟部中央標準局員工消费合作社印製 527194 A7 一丨丨·· 1 ~_丨 — - - B7 五、發明説明(2 ) ^ ~~一-一——- • ··· 視,因此適合在缺乏機器之加護病#或野戰醫院等場所使 用。進行CAVH治療時係利用自然的血液循·,環一 Γ即利用動 靜脈壓差。 _ CAVH是腎臟衰竭替代治療的另—種模式,其優點是緩和 且持續,可減少血㈣力學之干擾,而且不需要特殊機 器,專業人員也不需長時間在床邊監視,所以也是一種很 好的治療方法。下列情況是採用CAVH的適應症。 一、體液過剩 1. 忮性尿毒症病人發生肺積水但血壓卻不高,不適 合接受傳統血液透析治療時。 2. 急性尿母症病人。 (a) 血壓不穩定。 (b) 開心手術後。 (c) 心肌梗塞剛發生後之病人。 (d) 敗血症病人。 3·末期心臟病(嚴重鬱血性心臟衰竭)病人。 (a) 嚴重水腫無尿且對任何治療無效者。 經濟部中央標準局員工消費合作社印製 4·無尿病人但卻需要大量之輸液者。 ⑻hyperalimentation :如急性尿毒症病人需要TPN者。 5.慢性體液過剩者 ㈤腹水 (b) 腎病症候群 二 '落質之清除 當作急慢性尿秦症病人接受血液透析及腹膜透析的替 -5 - 本紙張尺度適用中國國家標準(CNS ) A4規格(210X297公釐) 527194 A7 B7 經濟部中央標準局員工消費合作社印製 五、發明説明(3 ) 代治療方法。 '' . 三、電解質異常 1. 代謝性鹼中毒 ^ 2. 代謝性酸中毒 3. 各種電解質異常如低鈉血症等。 近來年,醫界發現CAVH會增加動脈血栓機會且對低血壓 或周圍血管疾病者,會有血流量不穩現象,故研發出連續 性靜脈靜脈至血液過遽術(continuous venous venous hemotiltration, CWH),其係將二條導管插入靜脈,或利用一條雙腔導管 插入靜脈,藉由血液幫浦使血液流經體外循環。 雖然血液過濾術、CWH與CAVH的併發症不多,但常有 電解質及體液之不平衡及補充液的細菌感染問題。所以在 治療過程中需每一個時段(例如每小時)計算攝入及排出 量,並且監測血中各種電解質的濃度,並隨時注意以避免 細菌感染引起病患菌血症。由於有上述缺點,目前仍無法 普遍實施血液過濾術、CVVH與CAVH。 須知單純的過濾作用無法有效達到血液純化的目的,最 重要的還是需要補充液的n稀釋’’作用,所以不論是血液過 濾術、CVVH或CAVH,都需要添加適量之補充液,以維持 體液及電解質的穩定。 補充液的成份及濃度決定於病人的需要,基本上鈉離子 濃度約在140 mEq / L左右,乳酸、醋酸或重碳酸鹽濃度應 在20 - 40 mEq / L的範圍内。然而習知補充液最大的缺點在 於··(1)醋酸鹽須在肌肉及肝臟中才能代謝成碳酸鹽,因 -6 - 本紙張尺度適用中國國家標準(CNS ) A4規格(210 X 297公釐)527194 A7 B7 V. Description of the invention (1) .... The scope of the invention 2. The present invention relates to the supplementary liquid and component ash of hemofiltration, which is the first method. BACKGROUND OF THE INVENTION After the gradual loss of renal function produces symptoms of uremia, humans seek to find a variety of ways to replace the normally functioning kidney in order to sustain life. Among these alternatives, the most commonly used are dialysis treatments, including hemodialysis and peritoneal dialysis. However, the principle of dialysis treatment is not the same as the way the kidneys remove waste. In order to remove matter in a manner more similar to the human kidney's excretory function, hemofiltration is performed on the urn. Hemoperfusion is the use of "convective transport" to remove waste, which is not the same as the traditional hemodialysis using the diffusion principle. The so-called convection is the use of Starling's law, which will dissolve in the body fluid when it is discharged. The solute is taken out of the body together. Hemofiltration is the method used to remove waste. In addition to convection conduction, a uremic toxin-free supplement is also input into the body to maintain the integrity of body fluids and electrolytes and dilute the body. The concentration of endotoxin is used to reduce the concentration. So in theory, the principle of hemofiltration is quite similar to the function of the glomerulus. Continuous dynamic and static travel: continuous arteriovenous hemofiltration (CAVH) and blood The same filtration technique uses the principle of convection to remove waste, and then fills it with a suitable amount of supplemental liquid for dilution. The difference is that the former only uses the dynamic pressure difference, while the latter uses ultrafiltration pumps. Therefore, CAVH can be regarded as " "Slow-speed hemofiltration." Due to the use of arteriovenous pressure difference, there is no pump The negative pressure phenomenon caused by the action, so no need for various monitors and machinery equipment. · Since there is no need for machinery and professionals to monitor next-a paper size applies Chinese National Standard (CNS) A4 specifications (210X297 mm) (Please read the notes on the back IK ~ Pack-K) Order by the Consumers Cooperative of the Central Standards Bureau of the Ministry of Economic Affairs 527194 A7 丨 丨 · 1 ~ _ 丨---B7 V. Description of the invention (2) ^ ~~ 一-一 ——- ····, so it is suitable for use in places where there is a lack of machinery #care field # or field hospitals. CAVH treatment uses natural blood circulation. Poor. _ CAVH is another mode of renal failure replacement therapy, which has the advantage of being gentle and continuous, reducing the interference of hemodynamics, and does not require special machines, and professionals do not need to monitor at the bedside for a long time, so it is also A good treatment. The following conditions are indications for the use of CAVH. 1. Excessive fluid 1. Patients with urinary uremia develop hydronephrosis but the blood pressure is not high, which is not suitable for traditional hemodialysis treatment. 2. Patients with acute uremia. (A) Unstable blood pressure. (B) After happy surgery. (C) Patients immediately after myocardial infarction. (D) Patients with sepsis. 3. End-stage heart disease (severe congestive heart failure) ) Patients. (A) Those who have severe edema, no urine, and are ineffective for any treatment. Printed by the Consumer Cooperative of the Central Standards Bureau of the Ministry of Economic Affairs. 4. Patients without urine, but who require a large amount of infusion. ⑻hyperalimentation: For patients with acute uremia who need TPN 5. Chronic fluid excess patients with ascites (b) Elimination of nephrotic syndrome II's degraded as a substitute for acute and chronic urinary thyroid syndrome patients receiving hemodialysis and peritoneal dialysis-5-This paper applies Chinese National Standard (CNS) A4 Specifications (210X297 mm) 527194 A7 B7 Printed by the Consumer Cooperatives of the Central Standards Bureau of the Ministry of Economic Affairs V. Invention Description (3) Generation of treatment methods. '' III. Electrolyte abnormalities 1. Metabolic alkalosis ^ 2. Metabolic acidosis 3. Various electrolyte abnormalities such as hyponatremia. In recent years, the medical community has found that CAVH can increase the chance of arterial thrombosis and blood flow instability in patients with hypotension or peripheral vascular disease. Therefore, continuous venous to venous hemotiltration (CWH) has been developed. It involves inserting two catheters into a vein, or using a double-lumen catheter to insert a vein, and the blood is pumped through the extracorporeal circulation by a blood pump. Although the complications of hemofiltration, CWH, and CAVH are few, there are often problems with electrolyte and body fluid imbalances and bacterial infections with supplemental fluids. Therefore, during the treatment process, it is necessary to calculate the intake and discharge at each period (for example, every hour), and monitor the concentration of various electrolytes in the blood, and pay attention to avoid bacterial infection caused by bacteremia. Due to the aforementioned shortcomings, hemofiltration, CVVH and CAVH are currently not universally implemented. It should be noted that the simple filtering effect cannot effectively achieve the purpose of blood purification. The most important thing is the n-dilution effect of the supplement. Therefore, whether it is hemofiltration, CVVH or CAVH, you need to add an appropriate amount of supplement to maintain the body fluid and Electrolyte stability. The composition and concentration of the supplement depends on the needs of the patient. Basically, the sodium ion concentration is about 140 mEq / L, and the concentration of lactic acid, acetic acid, or bicarbonate should be in the range of 20-40 mEq / L. However, the biggest disadvantage of the conventional supplement is that (1) acetate must be metabolized into carbonate in muscle and liver, because -6-this paper size applies the Chinese National Standard (CNS) A4 specification (210 X 297 mm) )

527194 A7527194 A7

經濟部中央標準局員工消費合作社印製 此,大1的補給(每天高達5_10公升了'之醋酸鹽,會累積造 成心臟搏動壓抑及血管擴張,血壓下降的副,作g ;⑺乳酸 鹽須在肝臟中㈣,敗血症患者本身即有乳酸堆積;··,^ 上肝臟因休克而機能衰竭,將會使乳酸濃度更加提高丨及 ⑺大量過濾液將使身體碳酸鹽流失加劇,病人之阳:會更 加下降,代謝性酸中毒會更惡化,因此,補充液宜以:酸 鹽為缓衝劑。鈣離子及鎂離子要隨,時補充,但不能與重碳 酸鹽存放在同一袋内,因為兩者相遇容易發生沈澱。 目前國内外所採用血液過濾術之補充液均以5〇〇(^或1〇〇〇 cc之點滴做基劑,再加入各類所需離子臨時調配。在一般 使用下,一天往往需泡製30L〜4乩之補充液。操作單位軟 袋一天需更換至少數十次;所需安瓿針劑要至少數十支, 再使用同量空針筒抽取,加入軟袋中不僅有易感染疑慮, 離子濃度控制常因人為操作而不穩定,且泡製過程手續煩 瑣、耗時。 另外,目I業界所配製之補充液均以MgS〇4當作補充液 中〔Mg2+〕離子來源,然而〔so/-〕離子在正常血漿與尿毒 性血漿中(辰度分別為〇5與3毫克當量/升,詳言之〔so#2·〕 離子係腎臟排泄物,尤其使用血液墀濾術病患常為急性尿 母或嚴重腎衰竭病患,如再加入額外〔s〇42·〕離子,將會 加重病患之腎臟負擔,不利於該病患。 由上可知’目前業界在進行血液過濾術時,仍採用不利 於腎臟病患之〔Mg2+〕離子來源,且以複雜人工方式備製 補充液,不但費時’ ·離子濃度不穩定及易有細菌感染情形 -7 - 本纸張尺度適用中國國家標準(CNS ) Α4規格(210X297公釐) -裝-- (請先閲讀背面之注意事寫本頁) 、τ 527194 經濟部中央標準局員工消費合作社印製 A7 B7五、發明説明(5 ) .... 發生。因此,迫切需求能克服上述被點之血液過濾術之補 充液,以確實造福洗腎病患。 發明概述 本發明之目的係提供用於血液過濾術之補充液。 本發明之另一目的係提供用於血液過濾術之套組。 本發明之進一目的係提供製備血液過濾術之補充液之方 法。 本發明之詳細說明 本發明首提供一種用於血液過濾術之補充液,其含有: NaCl、鎂衍生物及CaCl2 _ 2H20,其中NaCl ··鎂衍生物加 CaCl2 · 2H20 之毫當量 / 升(meq /1)比值為 10 - 30 ·· 1,CaCl2 · 2H2〇:鎂衍生物之毫當量/升比值為0.5 - 8.0 : 1,但鎂衍生 物排除硫酸鎂。 文中所用”鎂衍生物”係指用作血液過濾術之鎂離子 〔Mg2+〕來源之鎂衍生物,其不具有不利於洗腎病患之離 子來源(如〔S〇42·〕離子)。較佳之鎂衍生物為MgCb · 6H2〇。 文中所用"血液過濾術”係指用對流傳導之原理來排除廢 物,再填充適量之補充液加以稀釋,包括連續性動靜脈血 液過;慮(CAVH)、連績性動靜血液透析過滤(cantinuous artery venous hemodiatiltration,CAVHD)連績性靜脈至靜脈血液過濾、 (CVVH) '連續性靜脈至靜脈血液透析過濾(CVVHD)及其它 改良之血液過滤術。 本發明之補充液中·各化合物係以習知技藝方式用合宜混 —8 - 本纸張尺度適用中國國家標準(CNS ) A4規格(210X297公釐) (請先閲讀背面之注意事 1. •裝-- :寫本頁) 訂 527194 A7 B7 五、發明説明(6 ) - 合比例與注射用水混合而形成均勻之f·補充液。.特定言之, NaCl :鎂衍生物加CaCl2 · 2H20之亳當量/升屯植為14 - 25 : 1,較佳為19 ·· 1,而其中CaCl2 · · 2·Η2〇:鎂衍生物之_當.量 /升比值為2.0 - 4 5 : 1,較佳為2.04 : 1。 上述補充液,與包含NaCl及NaHC03之補充液Β併用,其 中該補充液B中NaHC03 : NaCl之毫當量/升比值為5 - 15 : 11.5,較佳為 8.1-11.6 : 11.5,最佳為 10.82 : 11.5。 是以,本發明之補充液中具有下列各項離子濃度:This is printed by the Consumer Cooperative of the Central Standards Bureau of the Ministry of Economic Affairs. The supply of big 1 (up to 5-10 liters of acetate per day will accumulate and cause heart beat depression and vasodilation, and blood pressure will decrease as the side effect; g lactate must be in In the liver, septic patients have lactic acid accumulation; ..., ^ upper liver failure due to shock will increase the concentration of lactic acid 丨 and a large amount of filter fluid will increase the body's carbonate loss, the patient's yang: will It will decrease even more, and the metabolic acidosis will worsen. Therefore, the supplement should be: acid salt as a buffer. Calcium and magnesium ions should be added at any time, but not in the same bag with bicarbonate, because two Precipitation is easy to occur when people meet. At present, the supplements used in hemofiltration at home and abroad are based on 500 (^ or 1000 cc) drops, and then all kinds of ions are added for temporary preparation. Under general use In one day, 30L ~ 4 乩 of replenishment solution is often brewed. The soft bag of the operating unit needs to be replaced at least dozens of times a day; at least dozens of ampoule injections are needed, and then the same amount of empty syringe is used for extraction and added to the soft bag. Not only are there concerns about susceptibility to infection, the ion concentration control is often unstable due to human operation, and the brewing process is cumbersome and time-consuming. In addition, the supplements prepared by the industry in the industry use MgS04 as the supplement [Mg2 + ] Ion source, but [so /-] ions in normal plasma and urotoxic plasma (degrees are 05 and 3 mg equivalents / liter, respectively, in particular, [so # 2 ·] ions are renal excretion, especially used Hemofiltration patients are often acute urinary diarrhea or severe renal failure patients. If additional [s042 ·] ions are added, the kidney burden of the patient will be increased, which is not conducive to the patient. The industry still uses [Mg2 +] ion sources that are not good for kidney patients when preparing hemofiltration, and it is time-consuming to prepare supplements in a complicated manual way. • The ion concentration is unstable and bacterial infection is easy. Paper size applies Chinese National Standard (CNS) A4 specification (210X297 mm)-installed-(Please read the notes on the back to write this page first), τ 527194 Printed by A7 B7, Consumer Cooperative of the Central Standards Bureau of the Ministry of Economic Affairs Invention Description ( 5) .... Occurrence. Therefore, there is an urgent need to overcome the above-mentioned supplementary fluids for hemofiltration to ensure the benefit of kidney dialysis patients. SUMMARY OF THE INVENTION The object of the present invention is to provide supplements for hemofiltration. Another object of the present invention is to provide a kit for hemofiltration. A further object of the present invention is to provide a method for preparing a supplement for hemofiltration. DETAILED DESCRIPTION OF THE INVENTION The present invention provides a method for hemofiltration. The replenishing solution contains: NaCl, magnesium derivatives and CaCl2 _ 2H20, where the ratio of milli-equivalents / liter (meq / 1) of NaCl · · magnesium derivative plus CaCl2 · 2H20 is 10-30 ·· 1, CaCl2 · 2H2. : The ratio of milliequivalents / liter of magnesium derivatives is 0.5-8.0: 1, but magnesium derivatives exclude magnesium sulfate. As used herein, "magnesium derivative" refers to a magnesium derivative used as a source of magnesium ions [Mg2 +] for hemofiltration, which does not have an ion source (such as [S〇42 ·] ions) that is not conducive to dialysis patients. A preferred magnesium derivative is MgCb · 6H2O. "Hemofiltration" as used herein refers to the principle of convective conduction to eliminate waste, and then fill it with a suitable amount of supplemental fluid for dilution, including continuous arteriovenous blood transfusion; CAVH, continuous hemostatic filtration artery venous hemodiatiltration (CAVHD) continuous venous to venous hemofiltration, (CVVH) 'continuous venous to venous hemodiafiltration (CVVHD), and other improved hemofiltration techniques. The compounds in the supplement solution of the present invention are to be used Appropriate blending for know-how—8-This paper size applies to Chinese National Standard (CNS) A4 (210X297 mm) (Please read the notes on the back 1. • Installation-: Write this page) Order 527194 A7 B7 V. Description of the invention (6)-Mixing the proportion with water for injection to form a uniform f · supplement solution .. Specifically, the NaCl: magnesium derivative plus CaCl2 · 2H20 is equivalent to 14-25: 1 , Preferably 19 ·· 1, and wherein CaCl2 ·· 2 · Η20: _equivalent / liter ratio of the magnesium derivative is 2.0-4 5: 1, preferably 2.04: 1. The above-mentioned supplement solution, and Supplements B and NaCl and NaHC03 The NaHC03: NaCl milli-equivalent / liter ratio in the supplement B is 5-15: 11.5, preferably 8.1-11.6: 11.5, and most preferably 10.82: 11.5. Therefore, the supplement of the present invention has the following Various ion concentrations:

Na+ :125 - 150 毫當量/升; Ca2+ :0.1 -4.0 毫當量/升; Mg2+ ·· 0.1 -2.0 毫當量/升; cr :105 - 115 毫當量/升; hco3- :16-45 毫當量/升。 本發明較佳之補充液具有下列各項離子濃度: (請先閲讀背面之注意事 :寫本頁) 經濟部中央標準局員工消費合作社印製Na +: 125-150 meq / L; Ca2 +: 0.1 -4.0 meq / L; Mg2 + ·· 0.1 -2.0 meq / L; cr: 105-115 meq / L; hco3-: 16-45 meq / L Rise. The preferred supplement solution of the present invention has the following ion concentrations: (Please read the note on the back first: write this page) Printed by the Consumer Cooperative of the Central Standards Bureau of the Ministry of Economic Affairs

Na+ ••130-145 毫當量/升; Ca2+ :2.4-3.2 毫當量/升; Mg2+ :1.1-1.5 毫當量/升; cr :109- 113 毫當量/升; HCO, :25-36 毫當量/升。 最佳者具有下列各項離子濃度: Na+ :142.354 ; Ca2+ :2.60263 ; Mg2^ :1.27293 ; cr :112.8980 ; 一 9 一 本紙張尺度適用中國國家標準(CNS ) A4規格(210X297公釐) 527194 五、發明説明(7 HCO/ : 33.3294。 一 由於目前國内外所採用血液過濾術之補充無€以 Occ之點滴做基劑,再臨時加人各類 往 。補无硬,而且需頻頻更換軟袋供病患 所為。更々人垢病在於需扣關叙 而打開數十支安瓿針劑加至軟袋之 煩瑣與耗時泡製過程,不僅有易咸 4偟虿易感染或>了染疑慮(如引起 菌血症或加入安叛玻璃碎屑),離子濃度常因人為操作而 不穩足。是以本發明另提供—種巨量而成份穩定之血液過 滤術之補充液,其中本發明之補充液與補充液6之總容積 至少大於丨公升,較佳為6公升,最佳為1〇公升,而其中本 發明之補充液對補充液B之容積比(v/v)為i : i,補充液 B中NaCl : NaHC03之容積比(v/v)為1〇_ 13 : i,較佳為 11.5 : 1。 鑑於補充液中成份彼此會發生碳酸鈣沉澱,不利本發明 之補充液之儲存與使用便利性,是以本發明另提供一種用 於血液過〉慮術之套組,其包括 (A) 用於血液過濾術之補充液A,其包含NaCl、鎂衍生物及 CaCl2 . 2H20,其中NaCl :鎂衍生物加CaCl2 · 2H20之毫當 量 / 升(meq /1)比值為 10 - 30 ·· 1,CaCl2 · 2H20 ··鍰衍生物 之毫當量/升比值為0.5 - 8.0 : 1,但鎂衍生物排除硫酸鎂 之補充液,及 (B) 補充液B,其包含NaCl及NaHC03,其中該NaHC〇3 : NaCl 之毫當量/升比值為5 - 15 : 11.5。 補充液A中NaCl、鎂衍生物及CaCh · 2H20之毫當量/升比 一 10 — 本.紙張尺度適用中國國家標準(CNS ) A4規格(21〇'〆297公釐) ,HI I - · 1·!「丨丨—-丨裝—— (請先閱讀背面之注意事寫本頁) 線 經濟部中央標準局員工消費合作社印製 527194Na + •• 130-145 milliequivalents / liter; Ca2 +: 2.4-3.2 milliequivalents / liter; Mg2 +: 1.1-1.5 milliequivalents / liter; cr: 109-113 milliequivalents / liter; HCO ,: 25-36 milliequivalents / liter Rise. The best ones have the following ion concentrations: Na +: 142.354; Ca2 +: 2.60263; Mg2 ^: 1.27293; cr: 112.8980; 9 A paper size applies the Chinese National Standard (CNS) A4 specification (210X297 mm) 527194 V. Description of the invention (7 HCO /: 33.3294. First, as the current supplementation of hemofiltration used at home and abroad is not based on Occ drops, and then temporarily added to various types. No hardening, and frequent replacement of soft bags for What the patient does. It is more fouling due to the cumbersome and time-consuming brewing process of opening dozens of ampoules and adding them to the soft bag. It is not only easy to be salty, but also easy to be infected or > suspected of being infected (such as Cause bacteremia or add glass fragments), the ion concentration is often unstable due to human operation. The supplement provided by the present invention-a huge amount and a stable composition of hemofiltration, which is the supplement of the present invention The total volume of the liquid and the replenishing liquid 6 is at least greater than 丨 liters, preferably 6 liters, and most preferably 10 liters, and the volume ratio (v / v) of the replenishing liquid to the replenishing liquid B of the present invention is i: i, NaCl in Supplement B : The volume ratio (v / v) of NaHC03 is 10-13: i, preferably 11.5: 1. In view of the fact that the components in the replenishment liquid will precipitate calcium carbonate with each other, which is disadvantageous for the convenience of storage and use of the replenishment liquid of the present invention, According to the present invention, there is provided another set for blood treatment, which includes (A) a supplement A for hemofiltration, which includes NaCl, a magnesium derivative, and CaCl2. 2H20, where NaCl: a magnesium derivative Add the CaCl2 · 2H20 milli-equivalent / liter (meq / 1) ratio of 10-30 ·· 1, CaCl2 · 2H20 ·· pirate milli-equivalent / liter ratio is 0.5-8.0: 1, but exclude the magnesium derivative Supplementary solution of magnesium sulfate, and (B) Supplementary solution B, which includes NaCl and NaHC03, where the NaHC03: NaCl milli-equivalent / liter ratio is 5-15: 11.5. NaCl, magnesium derivatives and CaCh · 2H20 milli-equivalent / liter ratio-10 — this. Paper size applies Chinese National Standard (CNS) A4 specification (21〇'〇297 mm), HI I-· 1 ·! "丨 丨 —- 丨 installed — — (Please read the notes on the back first to write this page) Printed by the Consumers Cooperative of the Central Standards Bureau of the Ministry of Online Economy 527194

、發明説明(8) 經濟部中央標準局員工消費合作社印製 值與補充液B中NaCl及NaHC03之毫當I·/升比值,如上定義。 ^之補充液A與補充液b之總容積至少大於1公升,較佳 為6公升,最佳為10公升,而其中補充液A對補充液g之容 %比(V/V)為1 ·· 1,補充液B中NaCl : NaHC〇3之容積比 (V/ν)為 10-13 : i,較佳為115 · i。 頃發現,補充液B中補充液氏(NaC1及注射用水)合併補 充液B2(NaHC〇3及注射用水)放在軟.袋中進行滅菌時會產生 軟袋内含物析出現象,極'不利製造血液過濾術之補充液。 因此本發明採用一種新穎製法改良上述缺失。 疋以’本發明另提供一種用於製造血液過濾、術之補充液 之方法,其包括下列步騾·· ⑻調合NaCl、鎂衍生物、CaCl2 . 2H20及注射用水,形 成一補充液A, (b)調合NaCl及注射用水,形成一補充液Βι, ㈡調合NaHCCb及注射用水,形成一補充液b2, (d) 分別充填補充液a、及B2至容器中並進行滅菌, (e) 將補充液b2加至補充液Bl形成補充液b,及 (f) 混合補充液A及補充液B,形成血液過濾術之補充 液。 上述之補充液A中NaCl、鎂衍生物及CaCl2 · 2H2〇之毫當 量/升比值與補充液B中NaCl及NaHC03之毫當量/升比值如 上定義。上述之補充液A與補充液B之總容積至少大於1公 升,較佳為6公升,最佳為1〇公升,而其中補充液a對補 充液B之容積比(v / V)為1 : 1,補充液b中NaC1 : NaHCCh 一 11 - 本纸張尺度適用中國國家標準(CNS ) A4規格(210X297公楚) (請先閲讀背面之注意事寫本頁) 裝 527194 五、發明説明(9) 經濟部中央標準局員工消費合作社印製 之容積比(WV)為10_13:1,較佳為;115:1。 本發明之補充液及套組可 、丄、 ;J於通合習知血液過濾術所處 理之疾病與病況。 。另外,應知曉本發明之補充液及套組確實量係由醫護人 貝根據有關情況,包括撰闽A、、— " 、 、 硬過濾術、血中所需離子濃 度、病患《反應與病症之嚴重程度來決定。因此文中補充 /夜及套組中各成份所界定濃度、配.比與容積並非企圖以任 何方式來限制本發明之範圍。 為使本發明之目的、方法、原理及特徵更清晰明確,兹 以下文非限制性實例進一步詳細說明。 實例 材料及方法 下列補充液中所用成份均為符合GMP規訂,且用如下方 法配製: 刀別以主射用水碉合補充液A、Βι及B2中各成份,以分 別形成補充液A、Bi&B2。經過習知篩檢與過濾步驟,分 別充填至適當容器中,對該等容器滅菌。之後包裝該等容 器形成本發明之血液過濾術之套組。於適當時機(如即將 進行血液過滤術前)將補充液B2加革補充液形成補充液 B ’及混合補充液A及補充液B,形成本發明之血液過滤術 之補充液。 -12 - 本紙張尺度_ ( CNS ) A4^ (請先閲讀背面之注意事寫本頁) -裝· 、τ 527194 A7 B7 五、發明説明( 108. Description of the invention (8) The ratio between the printed value of the staff consumer cooperative of the Central Standards Bureau of the Ministry of Economic Affairs and the NaCl and NaHC03 in the supplement B is the same as the I · / liter ratio, as defined above. The total volume of supplement A and supplement b is at least 1 liter, preferably 6 liters, and most preferably 10 liters, and the volume% ratio (V / V) of supplement A to supplement g is 1 · · 1, the volume ratio (V / ν) of NaCl: NaHC03 in the supplement B is 10-13: i, preferably 115 · i. It was found that the supplement solution B (NaC1 and water for injection) and the supplement solution B2 (NaHC03 and water for injection) in the supplement B were placed in a soft bag. When the bag was sterilized, the contents of the soft bag would appear, which was extremely unfavorable. Creates hemofiltration supplements. Therefore, the present invention adopts a novel manufacturing method to improve the above defects. (1) The present invention further provides a method for manufacturing a supplement for blood filtration and surgery, which includes the following steps: ⑻ Blending NaCl, a magnesium derivative, CaCl2, 2H20, and water for injection to form a supplement A, ( b) Blend NaCl and water for injection to form a replenishment solution B1, ㈡ Blend NaHCCb and water for injection to form a replenishment solution b2, (d) Fill the replenishment solutions a and B2 into the container and sterilize them respectively, (e) replenish Liquid b2 is added to supplement B1 to form supplement b, and (f) the supplement A and supplement B are mixed to form a supplement for hemofiltration. The milliequivalent / liter ratio of NaCl, magnesium derivatives and CaCl2. 2H20 in the above-mentioned supplement A and the millie equivalent / liter ratio of NaCl and NaHC03 in the supplement B are as defined above. The total volume of the above-mentioned supplement A and supplement B is at least more than 1 liter, preferably 6 liters, and most preferably 10 liters, and the volume ratio (v / V) of supplement a to supplement B is 1: 1. NaC1 in replenishment solution b: NaHCCh -11-This paper size is applicable to Chinese National Standard (CNS) A4 (210X297). (Please read the note on the back first and write this page.) 527194 V. Description of invention (9 ) The volume ratio (WV) printed by the Consumer Cooperatives of the Central Standards Bureau of the Ministry of Economy is 10_13: 1, preferably 115: 1. The supplements and kits of the present invention can be used to understand the diseases and conditions treated by hemofiltration. . In addition, it should be known that the exact amount of the supplements and kits of the present invention is determined by the medical staff according to the relevant circumstances, including the preparation of A ,, — ",, hard filtration, the required ion concentration in the blood, the patient's "Reaction and The severity of the condition. Therefore, the concentrations, ratios, ratios, and volumes defined by the ingredients in the supplement / night and set are not intended to limit the scope of the invention in any way. In order to make the purpose, method, principle and characteristics of the present invention clearer and clearer, the following non-limiting examples are described in further detail. Example Materials and Methods The ingredients in the following supplements are in compliance with the GMP regulations, and are prepared by the following methods: The knife is combined with the main components of the supplements A, Bι, and B2 with water to form supplements A, Bi & amp, respectively. B2. After conventional screening and filtering steps, they are filled into appropriate containers and the containers are sterilized. These containers are then packaged to form the set of hemofiltration of the present invention. At the appropriate time (for example, before the hemofiltration operation is about to be performed), the replenishment solution B2 plus leather replenishment solution is formed into replenishment solution B ', and the replenishment solution A and replenishment solution B are mixed to form the replenishment solution for hemofiltration according to the present invention. -12-Size of this paper _ (CNS) A4 ^ (Please read the note on the back first to write this page)-Equipment · τ 527194 A7 B7 V. Description of the invention (10

補充液A 補充液氐 補充液B2 成份 NaCl CaCl2 · 2H2〇 MgCl2 · 6H2〇 NaCl NaHC03 實例1 ' 含量(毫克/毫升) 8.60278 0.38224 -0.2907 4.5 70 毫當量/并 147.207 5.2015 2.54587 77.0021 833.234 (請先閱讀背面之注意事Supplement solution A Supplement solution 氐 Supplement solution B2 Ingredients NaCl CaCl2 · 2H2〇MgCl2 · 6H2〇NaCl NaHC03 Example 1 'Content (mg / ml) 8.60278 0.38224 -0.2907 4.5 70 milliequivalents / and 147.207 5.2015 2.54587 77.0021 833.234 (Please read the back first Notice

裝-- _寫本頁)(Install-_ write this page)

補充液A 補充液h 經濟部中央標準局員工消費合作社印製 補充液B2 成份 NaCl CaCl2 · 2H2〇 MgCl2 · 6H2〇 NaCl NaHCO, 實例2 含量(毫克/毫升) 8.1324 0.44094 0.319718 4.5 52.50625 毫當量/升 139.158 6.000 2.800 77.0021 625 訂 —13 — 本纸張尺度適用中國國家標準(CNS ) A4規格(210X297公釐) 527194 A7 B7 五、發明説明(11Supplement A A Supplement h The component B2 printed by the Consumer Cooperatives of the Central Standards Bureau of the Ministry of Economic Affairs printed the supplement B2. NaCl CaCl2 · 2H2〇MgCl2 · 6H2〇NaCl NaHCO, Example 2 Content (mg / ml) 8.1324 0.44094 0.319718 4.5 52.50625 mE / L 139.158 6.000 2.800 77.0021 625 Order — 13 — This paper size applies to China National Standard (CNS) A4 (210X297 mm) 527194 A7 B7 V. Description of the invention (11

補充液A 補充液氏 補充液B2 成份 NaCl CaCl2 · 2H20 MgCl2 · 6H2〇 NaCl NaHCO, 實例3 ' 含量(毫克/毫升) 8.07396 0.51443 4.5 57.75688 毫當量/并 138.158 7.000 3.000 77.0021 687.5 (請先閱讀背面之注意事- •裝— I 寫本頁)Supplement A Supplement B's supplement B2 Ingredients NaCl CaCl2 · 2H20 MgCl2 · 6H2 NaCl NaHCO, Example 3 'Content (mg / ml) 8.07396 0.51443 4.5 57.75688 Meq // 138.158 7.000 3.000 77.0021 687.5 (Please read the note on the back first Things-• loading — I write this page)

補充液A 補充液h 經濟部中央標準局員工消費合作社印製 補充液B2 成份 NaCl CaCl2 · 2H2〇 MgCl2 · 6H2〇 NaCl NaHCO, 實例4 含量(毫克/毫升) 8.24928 0.36745 0.148441 4.5. 63.0075 毫當量/升 141.158 5,000 1.30 77.0021 750 訂 一 14 一 本纸張尺度適用中國國家標準(CNS ) A4規格(210X297公釐) 527194 A7 B7 五、發明説明(12 實例5Replenishment liquid A Replenishment liquid h Supplementary liquid B2 printed by the Consumer Cooperatives of the Central Standards Bureau of the Ministry of Economic Affairs Ingredients NaCl CaCl2 · 2H2〇MgCl2 · 6H2〇NaCl NaHCO, Example 4 Content (mg / ml) 8.24928 0.36745 0.148441 4.5. 63.0075 mEq / L 141.158 5,000 1.30 77.0021 750 Order one 14 One paper size applies Chinese National Standard (CNS) A4 specification (210X297 mm) 527194 A7 B7 V. Description of the invention (12 Example 5

補充液A 補充液氏 補充液B2Replenisher A Replenisher B2

補充液A 補充液h 經濟部中央標準局員工消費合作社印製 補充液B2 成份 含量(毫克/毫升) 毫當量7并 NaCl 8.4246 144.158 CaCl2 · 2H20 0.470336 6.400 MgCl2 · 6H2〇 -0.137022 1.200 NaCl 4.5 77.0021 NaHC03 68.25813 實例6 812.500 成份 含量(毫克/毫升) 毫當量/升 NaCl 8.59992 147.158 CaCl2 · 2H2〇 0.352752 4.800 MgCl2 · 6H2〇 0.125604 1.100 NaCl 4.5 77.0021 NaHCCh 75.609 900.000 使用實例 將雙腔導管插入需·進行血液過濾術病患(如急性腎衰竭) 15 - 本纸張尺度適用中國國家標準(CNS ) A4規格(210X297公釐) (請先閱讀背面之注意事^^寫本頁) —-裝- 訂 527194 A7 B7 五、發明説明(13 ) ·... 之内頸靜脈、鎖骨下靜脈及股靜脈5藉由血液.過濾術習知 方法經由體外血液幫浦控制血液流速且經ϋ i過濾器清 除廢物,以完成血液透析。 (請先閲讀背面之注意事 _寫本頁) 經濟部中央標準局員工消費合作社印製 -16 - 本纸張尺度適用中國國家標準(CNS ) Μ規格(210X 297公釐)Supplement A A Supplement h The content of the supplemental solution B2 printed by the Consumer Cooperatives of the Central Standards Bureau of the Ministry of Economic Affairs (mg / ml) Milli-equivalent 7 and NaCl 8.4246 144.158 CaCl2 · 2H20 0.470336 6.400 MgCl2 · 6H2 0-0.137022 1.200 NaCl 4.5 77.0021 NaHC03 68.25813 Example 6 812.500 Ingredient content (mg / ml) Milli-equivalent / liter NaCl 8.59992 147.158 CaCl2 · 2H2 〇0.352752 4.800 MgCl2 · 6H2 〇0.125604 1.100 NaCl 4.5 77.0021 NaHCCh 75.609 900.000 Use Example (Such as acute renal failure) 15-This paper size is applicable to Chinese National Standard (CNS) A4 (210X297 mm) (Please read the notes on the back first ^^ Write this page) —- Binding-Order 527194 A7 B7 V. Description of the invention (13) · ... The internal jugular vein, subclavian vein and femoral vein 5 are controlled by blood. The conventional method of filtering is to control the blood flow rate through an extracorporeal blood pump and remove waste through a ϋi filter to complete the blood. Dialysis. (Please read the notes on the back _ write this page) Printed by the Consumer Cooperatives of the Central Bureau of Standards of the Ministry of Economic Affairs -16-This paper size applies to the Chinese National Standard (CNS) M specifications (210X 297 mm)

Claims (1)

527194 第087119909號專利申請案 中文申請專利範圍修正本(91年10月) A8 B8 C8 D8 六、申請專利範圍f j ;# (10.23 ! 月 曰 ,充 1· 一種用於血液過滤術之補充液,其含有: NaCl, 鎂衍生物,及 CaCl2 · 2H20 ^ 其中NaCl ·誤4亍生物加CaCl〗· 2H2O之晕當量/升(meq /1) 比值為10 · 30 : 1,CaCl2 · 2氏0 :鎂衍生物之毫當量/升 比值為 0.5 - 8.0 ·· 1, 但鎂衍生物排除硫酸鎂。 2·根據申請專利範圍第1項之補充液,其中鎂衍生物為 MgCl2 · 6H20。 3·根據申請專利範圍第2項之補充液,其中NaCl :鎂衍生 物加CaCl2 · 2H20之毫當量/升比值為14 - 25 : 1。 4·根據申請專利範圍第2項之補充液,其中CaCl2 · 2H20 : 鎂衍生物之毫當量/升比值為2.0 - 4 5 : 1。 5·根據申請專利範圍第2項之補充液,其中NaCl :鎂衍生 物加CaCl2 · 2H20之毫當量/升比值為19 : 1。 6·根據申請專利範圍第2項之補充液,其中CaCl2 · 2H20 : 鎂衍生物之毫當量/升比值為2.04 : 1。 7·根據申請專利範圍第1至6項中任一項之補充液,其係 與包含NaCl及NaHC03之補充液B併用,其中該NaHC03 : NaCl之毫當量/升比值為5-15 : 11.5。 8·根據申請專利範圍第7項之補充液,其中補充液b中 本紙張尺度通用中國國家標準(CNS) A4規格(210 X 297公釐) 527194 A BCD 七、申請專利範圍 NaHC03 : NaCl之毫當量/升比值為 8.1 - 11.6 : 11.5。 9. 根據申請專利範圍第8項之補充液,其中補充液B中 NaHC03 : NaCl之毫當量/升比值為10.82 ·· 11.5。 10. 根據申請專利範圍第7項之補充液,其具有下列各項離 子濃度: Na+ :125 · 150 毫當量/升; Ca2+ :0.1-4.0 毫當量/升; Mg2+ :0.1-2.0 毫當量/升; Cl· :105- 115 毫當量/升; hc〇3* :16-45 毫當量/升。 11.根據申請專利範圍第10項之補充液,其具有下列各項 離子濃度: Na+ :130 - 145 毫當量/升; Ca2+ :2.4-3.2 毫當量/升; Mg2+ ·· 1.1-1.5 毫當量/升; cr :109- 113 毫當量/升;及 hco3- :25-36 毫當量/升。 根據申請專利範 圍第11項之補充液,其具有下列各項 離子濃度: Na+ ·· 142.354 毫 當量/升; Ca2+ :2.60263 毫 當量/升; Mg2+ :1.27293 毫 當量/升; -2- 本紙張尺度適用中國國家標準(CNS) A4規格(210 x 297公釐) 527194 六 A8 B8 C8 _____D8 、申請專利範圍 ~" C1* : 112.8980亳當量/升;及 HC〇3* : 33.3294 毫當量 / 升。 13. 根據申請專利範圍第7項之補充液,其中申請專利範圍 第1至6項中任一項之補充液對補充液b之容積比(v/v) 為 1 : 1。 14. 根據申請專利範圍第7項之補充液,其中申請專利範圍 第1至6項中任一項之補充液與補充液B之總容積至少 大於1公升。 15·根據申請專利範圍第14項之補充液,其中補充液b中 NaCl : NaHC03 之容積比(v/V)為 10-13 : 1。 16·根據申请專利範圍第15項之補充液,其中補充液b中 NaCl : NaHC03 之容積比(v/V)為 11.5 : 1。 17.根據申請專利範圍第16項之補充液,其中申請專利範 圍第1至6項中任一項之補充液與補充液B之總容積為6 公升。 18·根據申請專利範圍第16項之補充液,其中申請專利範 圍第1至6項中任一項之補充液與補充液B之總容積為 10公升。 19. 一種用於血液過濾術之套組,包括 (A) 根據申請專利範圍第1至6項中任一項之補充液 (B) 補充液B,其包含NaC1及NaHC〇3,其中該NaHC〇3 : NaCl之亳當量/升比值為5-15 ·· 115。 -3- 本紙張尺度適用中國國家標準(CNS) A4規格(210 X 297公爱) 527194 A B c D 申請專利範圍 20. 根據申請專利範園第19項之套組,其中補充液b中 NaHC03 : NaCl之亳當量/升比值為8」_ u 6 : u 5。 21. 根據申請專利範圍第20項之套組,其中補充液B中 NaHCCb : NaC1之亳當量/升比值為1〇及:n 5。 22. 根據申清專利範圍第19項之套組,其中申請專利範圍 第1至6項中任一項之補充液對補充液β之容積比(V/V) 為 1 · 1。 23·根據申請專利範圍第19項之套組,其中申請專利範圍 第1至6項中任一項之補充液與補充液Β之總容積至少 大於1公升。 24. 根據申請專利範圍第23項之套組,其中補充液Β中 NaCl : NaHC03 之容積比(V/V)為 1〇-13 : }。 25. 根據申請專利範圍第24項之套組,其中補充液β中 NaCl : NaHC03 之容積比(V/V)為 11.5 : i。 26. 根據申請專利範圍第25項之套組,其中申請專利範圍 第1至6項中任一項之補充液與補充液B之總容積為6公 升。 ' 27. 根據申請專利範圍第25項之套組,其中申請專利範圍 第1至6項中任一項之補充液與補充液B之總容積為 公升。 28· —種用於製造血液過濾術之補充液之方法,包括下列 步驟: 本紙張尺度適用中國國家標準(CNS) A4規格(210 X 297公釐) 527194 8 8 8 8 ABCD 六、申請專利範圍 ⑻調合NaCl、鎂衍生物、caci2 · 2H20及注射,用水,形 成一補充液A, (b) 調合NaCl及注射用水,形成一補充液氐, (c) 調合NaHCCb及注射用水,形成一補充液b2, (d) 分別充填補充液A、Bi及B2至容器中並進行滅菌, (e) 將補充液B2加至補充液Bl形成補充液b,及 (f) 混合補充液A及補充液b,形成血液過濾術之補充 液。 29. 根據申請專利範圍第28項之方法,其中補充液a中 NaCl :鎂衍生物加CaCi2 · 2H20之毫當量/升(meq/i)比值 10-30 : 1, CaCl2 · 2H20 :鎂衍生物之毫當量/升比值〇 5 _ 8 〇 : 1。 30. 根據申請專利範圍第29項之方法,其中補充液a中鍰 衍生物為MgCl2 . 6H20。 31. 根據申請專利範圍第3〇項之方法,其中Na(:1 :鎂衍生 物加CaCl2 · 2H20之毫當量/升比值為14 - 25 : 1。 根據申請專利範圍第3〇項之方法,其中caci2 · 2H20 : 鎂衍生物之毫當量/升比值為2.0 - 5.5 : 1。 °3·根據申請專利範圍第30項之方法,其中NaCl :鍰衍生 物加CaCl2 · 2H20之毫當量/升比值為19 : 1。 34·根據申請專利範圍第30項之方法,其中CaCi2 . 2h2〇 : 鎂衍生物之毫當量/升比值為2·04 : 1。 - 5- 本紙張尺度適用中國國家標準(CNS) Α4規格(210 X 297公釐) 27 5527194 Patent Application No. 087119909 Chinese Application for Amendment of Patent Scope (October 91) A8 B8 C8 D8 VI. Application for Patent Scope fj; # (10.23! Month, Fill 1. A supplementary solution for hemofiltration, It contains: NaCl, magnesium derivatives, and CaCl2 · 2H20 ^ where NaCl · 4 亍 biological plus CaCl · · halo equivalent / liter (meq / 1) ratio of 2H2O is 10 · 30: 1, CaCl2 · 2 degrees 0: The milli-equivalent / liter ratio of the magnesium derivative is 0.5-8.0 ·· 1, but the magnesium derivative excludes magnesium sulfate. 2 · According to the supplementary liquid of the scope of patent application item 1, wherein the magnesium derivative is MgCl2 · 6H20. 3 · According to The supplementary liquid of the second scope of the patent application, where the NaCl: magnesium derivative plus CaCl2 · 2H20 has a milliequivalent / liter ratio of 14-25: 1. 4. The supplementary liquid according to the second scope of the patent application, of which CaCl2 · 2H20 : The milli-equivalent / liter ratio of the magnesium derivative is 2.0-4 5: 1. 5. The supplementary liquid according to item 2 of the scope of the patent application, where the NaCl: magnesium derivative plus CaCl2 · 2H20 has the milli-equivalent / liter ratio of 19: 1. 6. Supplementary liquid according to item 2 of the scope of patent application, of which CaCl2 · 2H20: The milli-equivalent / liter ratio of the magnesium derivative is 2.04: 1. 7. According to any one of claims 1 to 6 of the scope of the patent application, the supplement liquid is used in combination with the supplement liquid B containing NaCl and NaHC03, The NaHC03: NaCl milli-equivalent / liter ratio is 5-15: 11.5. 8. According to the supplementary liquid in item 7 of the scope of patent application, wherein the paper size in the supplementary liquid b is the general Chinese National Standard (CNS) A4 specification (210 X 297 mm) 527194 A BCD VII. Patent application scope NaHC03: The milli-equivalent / liter ratio of NaCl is 8.1-11.6: 11.5. 9. According to the patent application scope item No. 8, the supplement solution is NaHC03: NaCl in supplement solution B The milli-equivalent / liter ratio is 10.82 ·· 11.5. 10. The supplementary liquid according to item 7 of the patent application scope has the following ion concentrations: Na +: 125 · 150 milli-equivalents / liter; Ca2 +: 0.1-4.0 milli-equivalents Mg2 +: 0.1-2.0 milli-equivalents / liter; Cl ·: 105-115 milli-equivalents / liter; hc〇3 *: 16-45 milli-equivalents / liter. 11. According to the supplementary liquid of item 10 of the scope of patent application, It has the following ion concentrations: Na +: 130-145 meq / L; Ca2 +: 2.4-3.2 meq / L; Mg2 + · 1.1-1.5 meq / L; cr: 109-113 meq / L; and hco3-: 25-36 meq / L. The supplement solution according to item 11 of the scope of the patent application has the following ion concentrations: Na + · 142.354 milliequivalents / liter; Ca2 +: 2.60263 milliequivalents / liter; Mg2 +: 1.27293 milliequivalents / liter; -2- Paper size Applicable to China National Standard (CNS) A4 specification (210 x 297 mm) 527194 six A8 B8 C8 _____D8, scope of patent application ~ " C1 *: 112.8980 亳 equivalent / liter; and HC〇3 *: 33.3294 milliequivalent / liter. 13. The supplementary liquid according to item 7 of the patent application scope, wherein the volume ratio (v / v) of the supplementary liquid to the supplemental liquid b of any one of the patent application scopes 1 to 6 is 1: 1. 14. The supplementary liquid according to item 7 of the patent application scope, wherein the total volume of the supplementary liquid and the supplemental liquid B of any one of the patent application scopes 1 to 6 is at least more than 1 liter. 15. The supplementary liquid according to item 14 of the scope of the patent application, wherein the volume ratio (v / V) of NaCl: NaHC03 in the supplemental liquid b is 10-13: 1. 16. The supplementary liquid according to item 15 of the scope of patent application, wherein the volume ratio (v / V) of NaCl: NaHC03 in the supplemental liquid b is 11.5: 1. 17. The supplement liquid according to item 16 of the patent application scope, wherein the total volume of the supplement liquid and the supplement liquid B of any one of the patent application scope items 1 to 6 is 6 liters. 18. The supplementary liquid according to item 16 of the patent application scope, wherein the total volume of the supplementary liquid and the supplemental liquid B of any one of the patent application scopes 1 to 6 is 10 liters. 19. A kit for hemofiltration, comprising (A) a supplement solution according to any one of claims 1 to 6 (B) a supplement solution B comprising NaC1 and NaHC03, wherein the NaHC 〇3: The NaCl equivalent / liter ratio is 5-15 ·· 115. -3- This paper size applies to China National Standard (CNS) A4 specification (210 X 297 public love) 527194 AB c D Application scope of patent 20. According to the set of item 19 of the patent application park, NaHC03 in supplement solution b: The NaCl equivalent / liter ratio is 8 ″ _ u 6: u 5. 21. The set according to item 20 of the scope of patent application, wherein the equivalent / liter ratios of NaHCCb: NaC1 in supplement B are 10 and: n 5. 22. According to the set of patent claim No. 19, the volume ratio (V / V) of the replenishment liquid to the replenishment liquid β in any one of the claims 1 to 6 is 1 · 1. 23. The set according to item 19 of the scope of patent application, wherein the total volume of the replenishment solution and the replenishment solution B of any one of the scope of patent applications 1 to 6 is at least greater than 1 liter. 24. The set according to item 23 of the scope of patent application, wherein the volume ratio (V / V) of NaCl: NaHC03 in the supplement B is 10-13:}. 25. The set according to item 24 of the scope of patent application, wherein the volume ratio (V / V) of NaCl: NaHC03 in the supplement β is 11.5: i. 26. According to the set of the scope of patent application No. 25, the total volume of the replenishment liquid and replenishment liquid B of any of the patent application scope Nos. 1 to 6 is 6 liters. '27. According to the set of the scope of patent application No. 25, the total volume of the replenishment liquid and replenishment liquid B of any of the patent application scope Nos. 1 to 6 is liters. 28 · —A method for manufacturing a supplement for hemofiltration, including the following steps: The paper size applies the Chinese National Standard (CNS) A4 specification (210 X 297 mm) 527194 8 8 8 8 ABCD ⑻ Blend NaCl, magnesium derivative, caci2 · 2H20 and water for injection to form a supplement A, (b) Blend NaCl and water for injection to form a supplement 氐, (c) Blend NaHCCb and water for injection to form a supplement b2, (d) Fill the replenishment solution A, Bi, and B2 into the container and sterilize them, (e) Add the replenishment solution B2 to the replenishment solution Bl to form the replenishment solution b, and (f) mix the replenishment solution A and the replenishment solution b. To form a supplement for hemofiltration. 29. The method according to item 28 of the scope of patent application, wherein the NaCl: magnesium derivative plus CaCi2 · 2H20 in meq / i (meq / i) ratio 10-30: 1, CaCl2 · 2H20: magnesium derivative in the supplement a The milli-equivalent / liter ratio is 0 5 _ 8 〇: 1. 30. The method according to item 29 of the scope of patent application, wherein the hydrazone derivative in the supplement a is MgCl2. 6H20. 31. The method according to item 30 of the scope of patent application, wherein the Na (: 1: magnesium derivative plus CaCl2 · 2H20 has a milliequivalent / liter ratio of 14-25: 1. According to the method of item 30 of the scope of patent application, Among them, the caci2 · 2H20: milli-equivalent / liter ratio of magnesium derivatives is 2.0-5.5: 1. ° 3 · According to the method in the scope of patent application No. 30, where NaCl: fluorene derivative plus CaCl2 · 2H20 milli-equivalent / liter ratio It is 19: 1. 34. The method according to item 30 of the scope of patent application, wherein the milli-equivalent / liter ratio of CaCi2. 2h20: magnesium derivative is 2.04: 1.-5-This paper size applies Chinese national standards ( CNS) Α4 size (210 X 297 mm) 27 5 A根據申請專利範圍第28項之方法,其中補,充液B中 NaHC〇3 : NaCl之毫當量/升比值為5_15 : 115。 36·根據申請專利範圍第35項之方法,其中補充液b中 NaHC03 : NaCl之毫當量/升比值為8丨-u 6 : n 5。 37.根據申請專利範圍第36項之方法,其中補充液B中 NaHC〇3 : NaCl之毫當量/升比值為10 82 : u 5。 38·根據申請專利範圍第28項之方法,其中補充液b中補 充液B2係在即將進行血液過濾術前加至補充液&。 39.根據申請專利範圍第28項之方法,其中補充液a對補 充液B之容積比(v / V )為1 ·· 1。 4〇·根據申請專利範圍第28項之方法,其中補充液a與補 充液B之總容積至少大於1公升。 41. 根據申請專利範圍第4〇項之方法,其中補充液b中 NaCl : NaHC03 之容積比(ν/V)為 10-13 : 1。 42. 根據申請專利範圍第41項之方法,其中補充液b中 NaCl : NaHC03 之容積比(ν/V)為 11.5 : 1。 43. 根據申請專利範圍第42項之方法,其中補充液a與補 充液B之總容積為6公升。 44. 根據申請專利範圍第42項之方法,其中補充液a與補 充液B之總容積為1〇公升。 -6 - 本紙張尺度適用中國國家標準(CNS) A4規格(210 X 297公董)A: The method according to item 28 of the scope of patent application, wherein the replenishment and filling solution B has a milliequivalent / liter ratio of NaHC03: NaCl of 5-15: 115. 36. The method according to item 35 of the scope of patent application, wherein the milli-equivalent / liter ratio of NaHC03: NaCl in the replenishment solution b is 8 丨 -u6: n5. 37. The method according to item 36 of the scope of patent application, wherein the NaHC03: NaCl in the supplement B has a milliequivalent / liter ratio of 10 82: u 5. 38. The method according to item 28 of the scope of patent application, wherein the supplement B2 in the supplement b is added to the supplement & immediately before the hemofiltration operation. 39. The method according to item 28 of the scope of patent application, wherein the volume ratio (v / V) of the replenishing liquid a to the replenishing liquid B is 1 ·· 1. 40. The method according to item 28 of the scope of patent application, wherein the total volume of the replenishing liquid a and the replenishing liquid B is at least more than 1 liter. 41. The method according to item 40 of the scope of the patent application, wherein the volume ratio (ν / V) of NaCl: NaHC03 in the supplement b is 10-13: 1. 42. The method according to item 41 of the scope of patent application, wherein the volume ratio (ν / V) of NaCl: NaHC03 in the supplementary liquid b is 11.5: 1. 43. The method according to item 42 of the scope of patent application, wherein the total volume of the replenishing liquid a and the replenishing liquid B is 6 liters. 44. The method according to item 42 of the scope of patent application, wherein the total volume of the supplement liquid a and the supplement liquid B is 10 liters. -6-This paper size applies to China National Standard (CNS) A4 (210 X 297 public directors)
TW87119909A 1998-12-01 1998-12-01 Replenisher and components for hemofiltration and method for producing the same TW527194B (en)

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