TW200906424A

TW200906424A - Pharmaceutical composition for use in hemofiltration or hemodialysis

Info

Publication number: TW200906424A
Application number: TW96129081A
Authority: TW
Inventors: Wen-Je Ko; Yi-Ming Chiu; Ching-Yi Chen
Original assignee: Taiwan Biotech Co Ltd
Priority date: 2007-08-07
Filing date: 2007-08-07
Publication date: 2009-02-16
Also published as: TWI373339B

Abstract

The present invention is directed to a hemofiltration / hemodialysis solution, which comprises a sodium salt or the hydrates thereof, a magnesium salt or the hydrates thereof, a calcium salt or the hydrates thereof and an organic acid salt or the hydrates thereof, wherein the solubility product constant of the calcium organic acid is higher than 6x10<SP>-9</SP> (25DEG C). The invention also provides a drug product, said product comprises at least two compartments or independent packages, and the components of the hemofiltration / hemodialysis solution are separately placed in the different compartments or packages with different combinations, wherein the compartment or package containing the calcium salt does not contain carbonate salt.

Description

200906424 九、發明說明：【發明所屬之技術領域】本發明係關於一種不易沉澱且易於使用的血液過濾或透析液及一種貯存本發明血液過濾或透析液之醫藥產品。【先前技術】血液透析係經由半透膜的兩端血液及透析液中的分子，經濃度的差異而互祖產生自由擴散的現象（diffusion)叫作透析作用》經由半透膜可使血液中的尿毒分子，經由透析液帶出體外。如果在透析液邊加上負壓或高透析壓物質如南濃度葡萄糖，則會使血液令的水份大量的移到透析液中，而帶離人體，此種作用稱為超過瀘（uhrafihati〇n)。企液透析是靠擴散（diffusion)及超過濾（ultrafiltrati〇n)來移除尿毒分子，但血液過濾則經由大量移除水分產生的對流效果（convection)來清除尿毒，與人體腎臟去除毒素的方式類似。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，血液過濾術就疋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。連續性動靜脈血液過遽術（c〇ntinu〇us 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。 115206.doc 200906424 不論是血液透析或血液過濾都需要適當之血液透析/血液過濾液，以維持體液及電解質的穩定。令華民國第 527194公告號專利揭示一種用於血液過濾術之補充液，其含有Naa、鎂衍生物及CaCl2.2H2〇，其中NaC1 :鎮衍生物加CaCl2.2H20之毫當量/升（meq/1)比值為1〇·3〇 :， CaCl2.2H20 :鎮衍生物之毫當量/升比值為〇 5_8 〇 : i，但鎂衍生物排除硫酸鎮。血液透析或血液過濾液的成份及濃 η 度決定於病人的需要，基本上鈉離子濃度約在140 rnEq/L 左右。血液透析或血液過濾液宜以碳酸鹽為缓衝劑。鈣離子及相遇容易加熱至約鎂離子要隨時補充，但鈣離子及鎂離子與碳酸鹽發生沈澱，且血液透析或血液過濾液於使用前須與體溫相當’而此加熱使沉澱增加。由於上述沉澱原因，為減少沉澱的發生，目前國内外所採用血液透析或血液過遽液均在使用前臨時調配再予加熱或將預先將會沉;殿的成分分開調配成溶液後，再於使用前予以混合並加熱。上述過耘易發生離子濃度控制不穩定，且泡製過程手續煩瑣之缺點。例如’ Gambr·。lnc. (St〇ckh()lm，⑽叫所生產的血液過濾/血液透析液產品，其碳酸氫納溶液須置於一分離容器並在使用前立即加入含其他成份之溶液。因此，仍有需要發展一種不易沉澱且使用方便之血液透析或血液過濾液。【發明内容】本發明提供一種血液過濾或透析液，其成份包含鈉鹽或 115206.doc 200906424 其水合物、鎮鹽或其水合物、鈣鹽或其水合物及有機酸鹽或其水合物’其中該有機酸根離子與鈣離子的Ksp值大於 6x 10'9(25°C );限制條件為當該有機酸為乳酸根時，其濃度低於30毫莫耳/升。本發明另提供一種醫藥產品，該產品包含至少兩個隔間或獨立包裝’且組成本發明血液過濾或透析液之組份係以不同組合分置於該等隔間或包裝，其中包含鈣鹽之隔間或 n 包裝不包含碳酸鹽。 ' 【實施方式】本發明係關於一種不易沉澱且易於使用的血液過濾或透析液，該血液過濾或透析液可在45。(：以下，超過24小時不產生沉澱。本發明係使用有機酸根或其水合物作為抗沉澱劑阻止碳酸#5沉;殿產生。據此，本發明血液過渡或透析液不須在使用前立即混合鈣鹽溶液及碳酸鹽溶液，易於使用。 I 本發明提供一種血液過濾或透析液，其成份包含鈉鹽或其水合物、鎂鹽或其水合物、鈣鹽或其水合物及有機酸鹽或其水合物’其中該有機酸根離子與鈣離子的Ksp值大於 6xl(T9 (25°C);限制條件為當該有機酸為乳酸根時，其濃度低於30毫莫耳/升。本文中之「Ksp值」為當溶液解離達平衡後’因為這些反應物以及生成物離子的濃度皆不改變，這些離子濃度就會達成一個固定的比例，我們叫他溶解度積常數 (solubility product constant)，Ksp。Ksp的數值愈大，表示 115206.doc 200906424 溶液中離子的濃度也愈大；也就是水溶解化合物時，化合物在水中分解成離子的數量也就愈多。本文中之「血液過濾術」係指用對流傳導之原理來排除廢物’再補充適量之補充液加以稀釋之技術，包括連續性動靜脈jk液過濾（CAVH)、連續性動靜贏液透析 (continuous artery venous hemodialysis，CAVHD)、連續性靜脈至靜脈血液過濾、（Continuous veno venous hemofiltration，CVVH)、連續性靜脈至靜脈血液透析過濾 (Continuous venovenous hemodiafiltration CVVHDF)及其它改良之jk液過渡術。本文中之「血液透析術」係指將病人血液中的溶質和水刀通過半透膜移入透析液中之技術’包括高效率透析術、高透量透析術及連續性血液透析術等。本文中之「沉澱」係指依照USP 30版法規注射液標準，每升溶液中粒徑大於25 μπι之粒子不得超過3個（USP 30, <788> Particulate Matter in Injection ’ 第 321 至 324 頁）。根據本發明之一具體實例，該血液過濾或透析液中之鈉鹽或其水合物為氯化納、碳酸氫納、硫酸納、乳酸納、檸樣酸納、酒石酸鈉、琥珀酸鈉、蘋果酸鈉、或其水合物或其組合，鎂鹽或其水合物為氣化鎂、碳酸鎂、硫酸鎂、或其水合物或其組合；鈣鹽或其水合物為氯化鈣、葡萄酸約、硫酸約、其水合物或其組合；及有機酸根或其水合物為檸樣酸根、乳酸根、酒石酸根、琥珀酸根、蘋果酸根、或其水合物或其組合。更佳鈉鹽為乳酸鈉、酒石酸鈉、檸 115206.doc 200906424 檬酸鈉、琥珀酸鈉、蘋果酸鈉、碳酸氫鈉或其水合物或其水合物之組合；鎂鹽為氯化鎂或氣化鎂.6H20 ;鈣鹽為氯化約或氣化舞·2Η2〇 ;及有機酸根之來源為乳酸納、檸檬酸鈉、酒石酸鈉、琥珀酸鈉、蘋果酸鈉、或其水合物或其組合。根據本發明之一較佳具體實施例，上述檸檬酸根或其水合物之來源包括，但不限於檸檬酸、檸檬酸水合物、檸檬酸二氫鈉、檸檬酸氫二鈉、檸檬酸三鈉、棒檬酸三鈉二水合物、檸檬酸二氫鉀、檸檬酸氫二鉀、檸檬酸鈣、檸檬酸鎂。上述乳酸根或其水合物之來源包括，但不限於乳酸、乳酸鈉、乳酸鉀、乳酸鈣、乳酸鎂三水合物。本發明之血液過濾或透析液中各離子來源之鹽類係以習知技藝方式用合宜鹽類混合適當比例並與注射用水混合而开> 成均勻之溶液。根據本發明之一具體實施例，該血液過遽或透析液之成份包含0.1-3.5 mg/1之乳酸納、4.0-7.5 mg/1之氯化鈉、0.05-0.35 mgA之氯化鎂、0.1-0.4 mg/l之氯化約及0-5.5 mg/1之碳酸氫納。較佳地，該血液過滤或透析液之成份包含0.3-2.5乳酸納、4.5-6.5mg/l之氯化納、〇.〇5-0.311^/1之氣化鎂及〇.15-〇.3511^/1之氣化鈣。更佳地，該血液過濾或透析液之成份包含約〇·9〇 mg/Ι之乳酸鈉、約 5_90 mg/1之氣化納、約〇·2〇 mg/i之氣化鎮、約〇 mgA之氣化約及約2.69 mg/1之碳酸氫鈉。根據本發明之另一具體實施例’該血液過濾或透析液之成份包含〇〇25_6 65 mg/1 之檸檬酸鈉水合物、4.75-7.00 mg/1之氣化鈉、0.045-0.35 mg/Ι之氣化鎂、0.13-0.37 mg/1之氣化鈣及〇-5.l〇mg/i之碳 115206.doc -10· 200906424 酸氫納。較佳地，該血液過濾、或透析液之成份包含0.07-0.60mg/l檸檬酸鈉水合物、4.95-6.75 mg/1之氣化鈉、 0.075-0.30 mg/1之氣化鎂及0.15-0.35 mg/Ι之氣化的。更佳地’該血液過渡或透析液之成份包含約〇 43 mg/1之檸檬酸二水合物、約6.3 5 mg/1之氣化鈉、約0.21 mg/Ι之氣化鎂及約0.19 mg/1之氯化鈣。雖然本發明血液過濾或透析液之組成已可減少沉殿產 p 生，為遲延沉澱產生並增加本發明血液過濾或透析液之儲存與使用便利性，可將本發明血液過濾或透析液分開置放貯存。據此，本發明另提供一種醫藥產品，該產品包含至少兩個隔間或獨立包裝，且組成本發明血液過濾或透析液之組份係以不同組合分置於該等隔間或包裝，其中包含鈣鹽之隔間或包裝不包含碳酸鹽。根據本發明，該醫藥包裝可包含兩個以上的隔間或獨立包裝，且本發明之血液過濾或透析液中之各成份可分別置於該不同隔間或獨立包裝中，其限制條件為鈣鹽與碳酸鹽不置於相同隔間或包裝。根據本發明之較佳具體實施例，本發明血液過濾或透析液之組份可分開置放於不同隔間或包裝，但不限於下列較佳具體實施例： 1 ·兩個隔間或包裝組合例1 : A邓伤.乳酸鈉（檸樣酸鈉、蘋果酸鈉、酒石酸鈉或琥珀酸鈉）' 氣化鈉、氣化鎂及氣化鈣。 B部份：碳酸氫鈉。 115206.doc 200906424 組合例2 : A部份：氯化鈉、氣化鎂及氯化鈣。 B部份：乳酸鈉（檸檬酸鈉、蘋果酸鈉、酒石酸納或琥王白酸鈉）及碳酸氫鈉。組合例3 : A部份：氯化鎂及氣化鈣。 B部份：氯化鈉、乳酸鈉（檸檬酸鈉、蘋果酸鈉、酒石酸納或琥ίό酸納）及碳酸氫納。組合例4 Α部份：氣化鈣。 B部份：氯化鎂、氯化鈉、乳酸鈉（檸檬酸鈉、蘋果酸納、酒石酸納或玻珀酸納）及碳酸氫納。 2.三個隔間或包裝組合例1 : A部份：乳酸鈉（檸檬酸鈉、蘋果酸鈉、酒石酸鈉或琥珀酸納）。 B部份：氣化鈉、氣化鎂及氣化鈣。 C部分：碳酸氫鈉。組合例2 : A部份：乳酸鈉（檸檬酸鈉、蘋果酸鈉、酒石酸鈉或琥珀酸納）、氣化納。 B部份：氣化鎂及氣化弼。 C部分：碳酸氫鈉。組合例3 : 115206.doc -12- 200906424 A部份：乳酸鈉（檸檬酸鈉、蘋果酸鈉、酒石酸鈉或琥珀酸納）、氣化納、峻酸氫納。 B部份：氣化鎂。 C部分：氣化鈣。組合例4 A部份：乳酸鈉（檸檬酸鈉、蘋果酸鈉、酒石酸鈉或琥珀酸納）。 B部份：氯化鎂及氯化鈣。 C部分：氣化納、碳酸氫納。上述各組合例中之各成份之濃度係控制為鈉離子、鎂離子、鈣離子、氯離子、乳酸根及碳酸氫根混合後之濃度，須與前述直接混合並置於一包裝（非分開包裝）之本發明企液過濾或透析液相同。根據本發明之一較佳具體實施例’各離子混合後之濃度如下：鈉離子：125_15〇 mEq/L、鎂離子：0.50-3,0 mEq/L、詞離子：2.0-50 mEq/L、氯離子：90-120 mEq/L、乳酸根及碳酸氫根：低於30 mEq/L。較佳地，各離子混合後之濃度如下：鈉離子：約141.00 mEq/L、鎂離子：約2.00 mEq/L、妈離子：約2.50 mEq/L、氣離子：約105.45 mEq/L、乳酸根：約 8.00 mEq/L及碳酸根：約32.05 mEq/L。較佳地，各離子混合後之濃度如下：約140.72 mEq/L、鎂離子：約2 〇〇 mEq/L、！弓離子：約2.50 mEq/L、氣離子：約1〇8 95 mEq/L、檸檬酸根：約4.22 mEq/L及碳酸根：約32 〇5 mEq/L。較佳地’各離子混合後之濃度如下：鈉離子：約 115206.doc •13, 200906424 l4〇_93 mEq/L、鎂離子：約 2 〇〇 mEq/L、鈣離子：約 2 5〇 mEq/L、氯離子：約109.45 mEq/L、酒石酸根：約3 93 mEq/L及碳酸根：約32·〇5 mEq/L。較佳地，各離子混合後之濃度如下：鈉離子：約14〇 92 mEq/L、鎂離子：約 2.00 mEq/L、鈣離子：約 2·5〇 mEq/L、氣離子：約 1〇9 45 mEq/L、琥ϊό酸根：約3.92 mEq/L及碳酸根：約32 〇5 mEq/L。較佳地，各離子混合後之濃度如下：鈉離子：約 141-0 、鎂離子：約2.〇〇 mEq/L、鈣離子：約2.5〇 " mEq/L、氯離子：約109.45 mEq/L、蘋果酸根：約4 〇〇 mEq/L及碳酸根.約32.05 mEq/L。也可依據需求加入葡萄糖或其水合物控制混合後之濃度為〇_25 mm〇l/L。根據本毛月任何客知的醫藥上可接受容器均能用於本發明醫藥產品中之隔間或包裝。本發明之血液過濾或透析液及醫藥產品可用於適合習知血液過濾術所處理之疾病與病況。本發明血液過濾或透析液成份可以濃縮液之型式存〇在。根據本發明’本發明金液過濾或透析液為濃縮液，該濃縮液之各成份濃度為原濃度之1至40倍；較佳為丨.2至30 ^ L2至2〇倍，丨·2至10倍或丨·2至5倍。更佳地，濃縮後之各成份濃度為原成份濃度之1.2至3倍，1.2至2倍，1.2至 1.75倍或1.2至1.5倍。另外，應知曉本發明之血液過濾或透析液及醫藥產品中成分的確實使用量係由醫護人員根據有關情況，包括選用血液過遽術、血中所需離子濃度、病患之反應與病症之嚴重私度來决定。因此文中補充液及套組中各成份所界定濃 ll5206.doc •14- 200906424 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，茲以下文非限制性實例進一步詳細說明。實施例實例1 本發明血液過濾或透析液之製備本發明血液過濾或透析液中所用成份均為符合GMP規定，其係以注射水調合各成份而製備。經過習知篩檢與過濾步驟，分別充填至適當容器中並滅菌。本發明血液過濾或透析液之配方例如下：配方例1 含量(毫克/毫升) 0.90 5.90 0.20 0.18 2.69 含量(毫克/毫升) 0.43 6.35 0.21 0.19 成份200906424 IX. Description of the Invention: [Technical Field] The present invention relates to a blood filtration or dialysis solution which is not easily precipitated and easy to use, and a medical product for storing the blood filtration or dialysate of the present invention. [Prior Art] Hemodialysis is a phenomenon in which blood is separated from the blood at both ends of the semipermeable membrane and the molecules in the dialysate by the difference in concentration, and the mutual diffusion is called dialysis. The uremic molecule is taken out of the body via dialysate. If a negative pressure or a high dialysis pressure substance such as a southern concentration of glucose is added to the dialysate, the amount of water caused by the blood is transferred to the dialysate and taken away from the human body. This effect is called more than 泸 (uhrafihati〇) n). Liquid dialysis relies on diffusion and ultrafiltration (ultrafiltrati〇n) to remove uremic molecules, but blood filtration removes urinary venom through a large amount of convection to remove water, and removes toxins from human kidneys. similar. The so-called convective conduction is the use of Starling's law. When discharged by body fluids, the solute dissolved in it is taken out of the body, and blood filtration uses this method to remove waste. In addition to convective conduction, a urinary toxin-free replenisher is also introduced into the body to maintain the integrity of the body fluids and electrolytes, and to dilute the concentration of residual toxins in the body to achieve a reduced concentration. Continuous arteriovenous hemofiltration (CAVH) is the same as hemofiltration. The principle of convection conduction is used to remove waste, and then diluted with an appropriate amount of supplement solution. The difference is that the former uses only the pressure difference between the static and the static, while the latter uses the ultra-filtering pump. 115206.doc 200906424 Appropriate hemodialysis/blood filtration is required for hemodialysis or hemofiltration to maintain body fluid and electrolyte stability. The Patent No. 527194 of the Republic of China discloses a replenishing solution for hemofiltration, which contains Naa, a magnesium derivative and CaCl2.2H2, wherein NaC1: a town derivative plus a molar equivalent of CaCl2.2H20 / liter (meq/ 1) The ratio is 1〇·3〇:, CaCl2.2H20: the milliequivalent/liter ratio of the town derivative is 〇5_8 〇: i, but the magnesium derivative excludes sulphuric acid. The composition and concentration of hemodialysis or blood filtration depends on the patient's needs, and the sodium ion concentration is approximately 140 rnEq/L. Hemodialysis or blood filtration should preferably use carbonate as a buffer. Calcium ions and encounters are easy to heat up to about. Magnesium ions should be replenished at any time, but calcium ions and magnesium ions and carbonates precipitate, and hemodialysis or blood filtrate must be equal to body temperature before use. This heating increases the precipitation. Due to the above precipitation reasons, in order to reduce the occurrence of sedimentation, hemodialysis or blood percolation currently used at home and abroad are temporarily prepared and heated before use or will be pre-sinked; the components of the temple are separately formulated into a solution, and then Mix and heat before use. The above-mentioned excessive enthalpy is liable to be unstable in ion concentration control and cumbersome in the process of the brewing process. For example, 'Gambr. Lnc. (St〇ckh()lm, (10) is called the blood filtration/hemodialysis solution product. The sodium bicarbonate solution should be placed in a separate container and added to the solution containing other ingredients immediately before use. Therefore, there is still There is a need to develop a hemodialysis or blood filtration solution which is difficult to precipitate and is convenient to use. SUMMARY OF THE INVENTION The present invention provides a blood filtration or dialysate whose composition comprises a sodium salt or 115206.doc 200906424 hydrate, salt or hydrate thereof a calcium salt or a hydrate thereof and an organic acid salt or a hydrate thereof, wherein the organic acid ion and the calcium ion have a Ksp value greater than 6 x 10'9 (25 ° C); and the limiting condition is when the organic acid is lactate, The concentration is less than 30 millimoles per liter. The invention further provides a pharmaceutical product comprising at least two compartments or a separate package 'and the components comprising the blood filtration or dialysate of the invention are placed in different combinations The compartment or package containing the calcium salt compartment or the n package does not contain carbonate. 'Embodiment】 The present invention relates to a blood filtration or dialysate which is not easily precipitated and is easy to use. The liquid filtration or dialysate may be at 45. (: The following, no precipitation occurs for more than 24 hours. The present invention uses organic acid or its hydrate as an anti-precipitation agent to prevent carbonation; the temple is produced. Accordingly, the blood transition of the present invention Or the dialysate does not need to be mixed with the calcium salt solution and the carbonate solution immediately before use, and is easy to use. I The present invention provides a blood filtration or dialysate whose composition comprises a sodium salt or a hydrate thereof, a magnesium salt or a hydrate thereof, calcium a salt or a hydrate thereof and an organic acid salt or a hydrate thereof, wherein the organic acid ion and the calcium ion have a Ksp value greater than 6 x 1 (T9 (25 ° C); and the restriction condition is that when the organic acid is lactate, the concentration is low At 30 millimoles per liter. The "Ksp value" in this paper is when the solution dissociates to equilibrium. 'Because these reactants and the concentration of the product ions do not change, these ion concentrations will reach a fixed ratio, we call His solubility product constant, the larger the value of Ksp.Ksp, indicates the concentration of ions in the solution 115206.doc 200906424; that is, when the water dissolves the compound, the compound is in water. The more the amount of ions is decomposed into ions. In this paper, "hemofiltration" refers to the technique of using convection conduction to eliminate waste 'replenishing appropriate amount of supplement solution to dilute, including continuous arteriovenous jk liquid filtration ( CAVH), continuous arterial venous hemodialysis (CAVHD), continuous veno venous hemofiltration (CVVH), continuous venovenous hemodiafiltration (CVVHDF) and Other improved jk fluid transitions. As used herein, "hemodialysis" refers to the technique of transferring solute and water jets from a patient's blood through a semi-permeable membrane into a dialysate, including high-efficiency dialysis, high-through dialysis, and continuous hemodialysis. “Precipitation” as used herein shall mean no more than 3 particles having a particle size greater than 25 μm per liter of solution in accordance with USP 30 regulations. (USP 30, <788> Particulate Matter in Injection 'pages 321 to 324 ). According to an embodiment of the present invention, the sodium salt or hydrate thereof in the blood filtration or dialysate is sodium chloride, sodium hydrogencarbonate, sodium sulfate, sodium lactate, sodium citrate, sodium tartrate, sodium succinate, apple The sodium salt, or a hydrate thereof or a combination thereof, the magnesium salt or a hydrate thereof thereof is magnesium gas, magnesium carbonate, magnesium sulfate, or a hydrate thereof or a combination thereof; the calcium salt or a hydrate thereof is calcium chloride or grape acid And sulfuric acid, a hydrate thereof or a combination thereof; and the organic acid or a hydrate thereof is a lemon-like acid root, a lactate, a tartrate, a succinate, a malate, or a hydrate thereof or a combination thereof. More preferred sodium salt is sodium lactate, sodium tartrate, lemon 115206.doc 200906424 sodium citrate, sodium succinate, sodium malate, sodium hydrogencarbonate or a combination thereof or a hydrate thereof; magnesium salt is magnesium chloride or magnesium gasification. 6H20; the calcium salt is chlorinated or gasified and danced; and the source of the organic acid radical is sodium lactate, sodium citrate, sodium tartrate, sodium succinate, sodium malate, or a hydrate thereof or a combination thereof. According to a preferred embodiment of the present invention, the source of the above citrate or its hydrate includes, but is not limited to, citric acid, citric acid hydrate, sodium dihydrogen citrate, disodium hydrogen citrate, trisodium citrate, Trisodium citrate dihydrate, potassium dihydrogen citrate, dipotassium hydrogen citrate, calcium citrate, magnesium citrate. Sources of the above-mentioned lactate or a hydrate thereof include, but are not limited to, lactic acid, sodium lactate, potassium lactate, calcium lactate, and magnesium lactate trihydrate. The salts of each ion source in the blood filtration or dialysate of the present invention are mixed in a suitable ratio with a suitable salt in a conventional manner and mixed with water for injection to form a homogeneous solution. According to a specific embodiment of the present invention, the blood permeation or dialysate component comprises 0.1-3.5 mg/1 sodium lactate, 4.0-7.5 mg/1 sodium chloride, 0.05-0.35 mg A magnesium chloride, 0.1-0.4. Chlorination of mg/l and sodium bicarbonate of 0-5.5 mg/1. Preferably, the blood filtration or dialysate component comprises 0.3-2.5 sodium lactate, 4.5-6.5 mg/l sodium chloride, 〇.〇5-0.311^/1 of magnesia and 〇.15-〇. Calcified calcium of 3511^/1. More preferably, the blood filtration or dialysate component comprises about 〇·9〇mg/Ι of sodium lactate, about 5_90 mg/1 of gasification sodium, about 〇·2〇mg/i of gasification town, about 〇mgA The gasification is about 2.69 mg/1 sodium bicarbonate. According to another embodiment of the present invention, the blood filtration or dialysate component comprises 柠檬25_6 65 mg/1 sodium citrate hydrate, 4.75-7.00 mg/1 sodium sulphate, 0.045-0.35 mg/Ι Magnesium vapor, 0.13-0.37 mg/1 of calcium carbonate and 〇-5.l〇mg/i of carbon 115206.doc -10· 200906424 hydrogen hydride. Preferably, the blood filtration or dialysate component comprises 0.07-0.60 mg/l sodium citrate hydrate, 4.95-6.75 mg/1 sodium vapor, 0.075-0.30 mg/1 magnesium oxide and 0.15- 0.35 mg / 气 gasification. More preferably, the composition of the blood transition or dialysate comprises about 43 mg/1 citric acid dihydrate, about 6.3 5 mg/1 sodium vapor, about 0.21 mg/Ι magnesium gas, and about 0.19 mg. /1 calcium chloride. Although the composition of the blood filtration or dialysate of the present invention can reduce the production of the spleen, the hemofiltration or dialysate of the present invention can be separated for delaying sedimentation and increasing the convenience of storage and use of the blood filtration or dialysate of the present invention. Put it in storage. Accordingly, the present invention further provides a pharmaceutical product comprising at least two compartments or separate packages, and the components comprising the blood filtration or dialysate of the present invention are placed in the compartments or packages in different combinations, wherein The compartment or package containing calcium salts does not contain carbonate. According to the present invention, the medical package may comprise more than two compartments or separate packages, and the components of the blood filtration or dialysate of the present invention may be placed in the different compartments or in separate packages, respectively, with the restriction being calcium. Salt and carbonate are not placed in the same compartment or package. In accordance with a preferred embodiment of the present invention, the components of the blood filtration or dialysate of the present invention may be placed separately in different compartments or packages, but are not limited to the following preferred embodiments: 1 • Two compartments or combination of packages Example 1: A Deng injury. Sodium lactate (sodium citrate, sodium malate, sodium tartrate or sodium succinate)' gasified sodium, magnesium gasification and calcium carbonate. Part B: sodium bicarbonate. 115206.doc 200906424 Combination Example 2: Part A: sodium chloride, magnesium gasification and calcium chloride. Part B: Sodium lactate (sodium citrate, sodium malate, sodium tartrate or sodium sulphate) and sodium bicarbonate. Combination Example 3: Part A: Magnesium chloride and calcium carbonate. Part B: sodium chloride, sodium lactate (sodium citrate, sodium malate, sodium tartrate or sodium sulphate) and sodium bicarbonate. Combination Example 4 Part: Calcified calcium. Part B: magnesium chloride, sodium chloride, sodium lactate (sodium citrate, sodium malate, sodium tartrate or sodium bourbate) and sodium bicarbonate. 2. Three compartments or packaging Combination Example 1: Part A: Sodium lactate (sodium citrate, sodium malate, sodium tartrate or sodium succinate). Part B: gasified sodium, magnesium gasification and calcium carbonate. Part C: sodium bicarbonate. Combination Example 2: Part A: sodium lactate (sodium citrate, sodium malate, sodium tartrate or sodium succinate), gasified sodium. Part B: Magnesium gasification and gasification. Part C: sodium bicarbonate. Combination Example 3: 115206.doc -12- 200906424 Part A: Sodium lactate (sodium citrate, sodium malate, sodium tartrate or sodium succinate), gasified sodium, sodium hydrogen sulphate. Part B: Magnesium vapor. Part C: Calcified calcium. Combination Example 4 Part A: Sodium lactate (sodium citrate, sodium malate, sodium tartrate or sodium succinate). Part B: Magnesium chloride and calcium chloride. Part C: gasified sodium, sodium bicarbonate. The concentration of each component in each of the above combinations is controlled to be a concentration of sodium ions, magnesium ions, calcium ions, chloride ions, lactate and bicarbonate, and is directly mixed with the above and placed in a package (not separately packaged). The liquid filtration or dialysate of the present invention is the same. According to a preferred embodiment of the present invention, the concentration of each ion after mixing is as follows: sodium ion: 125_15 〇 mEq/L, magnesium ion: 0.50-3, 0 mEq/L, word ion: 2.0-50 mEq/L, Chloride ion: 90-120 mEq/L, lactate and bicarbonate: less than 30 mEq/L. Preferably, the concentration of each ion after mixing is as follows: sodium ion: about 141.00 mEq/L, magnesium ion: about 2.00 mEq/L, mother ion: about 2.50 mEq/L, gas ion: about 105.45 mEq/L, lactate : about 8.00 mEq/L and carbonate: about 32.05 mEq/L. Preferably, the concentration of each ion after mixing is as follows: about 140.72 mEq/L, magnesium ion: about 2 〇〇 mEq/L, ! Bow ion: about 2.50 mEq/L, gas ion: about 1 〇 8 95 mEq/L, citrate: about 4.22 mEq/L and carbonate: about 32 〇 5 mEq/L. Preferably, the concentration of each ion after mixing is as follows: sodium ion: about 115206.doc • 13, 200906424 l4〇_93 mEq/L, magnesium ion: about 2 〇〇mEq/L, calcium ion: about 2 5 〇mEq / L, chloride ion: about 109.45 mEq / L, tartrate: about 3 93 mEq / L and carbonate: about 32 · 〇 5 mEq / L. Preferably, the concentration of each ion after mixing is as follows: sodium ion: about 14 〇 92 mEq / L, magnesium ion: about 2.00 mEq / L, calcium ion: about 2 · 5 〇 mEq / L, gas ion: about 1 〇 9 45 mEq/L, succinate: about 3.92 mEq/L and carbonate: about 32 〇 5 mEq/L. Preferably, the concentration of each ion after mixing is as follows: sodium ion: about 141-0, magnesium ion: about 2. 〇〇mEq/L, calcium ion: about 2.5 〇 " mEq/L, chloride ion: about 109.45 mEq /L, malate root: about 4 〇〇mEq / L and carbonate. About 32.05 mEq / L. It is also possible to add glucose or a hydrate thereof as required to control the concentration to be 〇25 mm〇l/L. Any of the pharmaceutically acceptable containers known to the present invention can be used in the compartment or package of the pharmaceutical product of the present invention. The blood filtration or dialysate and medical product of the present invention can be used to adapt to diseases and conditions handled by conventional blood filtration techniques. The blood filtration or dialysate component of the present invention may be in the form of a concentrate. According to the present invention, the gold liquid filtration or dialysate of the present invention is a concentrated liquid, and the concentration of each component of the concentrated liquid is 1 to 40 times the original concentration; preferably 丨. 2 to 30 ^ L2 to 2 times, 丨·2 Up to 10 times or 丨 2 to 5 times. More preferably, the concentration of each component after concentration is 1.2 to 3 times, 1.2 to 2 times, 1.2 to 1.75 times or 1.2 to 1.5 times the concentration of the original component. In addition, it should be understood that the actual use of the components of the blood filtration or dialysate and the medical product of the present invention is determined by the medical staff according to the relevant circumstances, including the selection of blood transfusion, the required ion concentration in the blood, the reaction and the condition of the patient. Strictly private to decide. Therefore, the definitions, ratios, and volumes defined by the ingredients in the supplements and kits are not intended to limit the scope of the invention in any way. To clarify the objects, methods, principles, and features of the present invention, the following non-limiting examples are further described in detail. EXAMPLES Example 1 Preparation of Blood Filtration or Dialysate of the Present Invention The components used in the blood filtration or dialysate of the present invention are all in compliance with GMP regulations, and are prepared by blending the components with water for injection. After conventional screening and filtration steps, they are separately filled into suitable containers and sterilized. The formulation of the blood filtration or dialysate of the present invention is as follows: Formulation Example 1 Content (mg/ml) 0.90 5.90 0.20 0.18 2.69 Content (mg/ml) 0.43 6.35 0.21 0.19 Ingredients

Sodium Lactate Sodium Chloride Magnesium Chloride 6H20Sodium Lactate Sodium Chloride Magnesium Chloride 6H20

Calcium Chloride 2H20Calcium Chloride 2H20

Sodium Hydroen Carbonate 配方例2 成份Sodium Hydroen Carbonate Formulation 2 Ingredients

Sodium Citrate 2H20 Sodium Chloride Magnesium Chloride 6H20Sodium Citrate 2H20 Sodium Chloride Magnesium Chloride 6H20

Calcium Chloride 2H2O 115206.doc -15- 200906424 配方例3 成份含量(毫克/毫升)Calcium Chloride 2H2O 115206.doc -15- 200906424 Formulation Example 3 Ingredient Content (mg/ml)

Sodium Tatrate 2H20 0.47 Sodium Chloride 6.38Sodium Tatrate 2H20 0.47 Sodium Chloride 6.38

Magnesium Chloride 6H20 0.21 Calcium Chloride 2H2O 0.19 配方例4 成份 Sodium Succinate Sodium Chloride 含量(毫克/毫升) 0.33 6.38Magnesium Chloride 6H20 0.21 Calcium Chloride 2H2O 0.19 Formulation 4 Ingredients Sodium Succinate Sodium Chloride Content (mg/ml) 0.33 6.38

Magnesium Chloride 6H20 0.21 Calcium Chloride 2H2O 0.19Magnesium Chloride 6H20 0.21 Calcium Chloride 2H2O 0.19

配方例5 成份 Disodium DL-Malate Sodium Chloride Magnesium Chloride 6H2O Calcium Chloride 2H20 含量(毫克/毫升) 0.37 6.38 0.21 0.19 實例2 本發明含血液過濾或透析液之醫藥包裝之製備分別以注射用水調合下述補充液A及B中各成份，以分別形成補充液A及B。經過習知篩檢與過濾步驟，分別充填至一醫藥容器之不同隔間或包裝中。對該等容器滅菌並 115206.doc -16- 200906424 形成本發明之血液過濾/透析液產品。於適當時機將補充液B加至補充液A並混合均勻形成本發明血液過濾/透析液。 1 ·配方例1 將上述配方例1中之成份分開成A及B部分如下所示方式調配：Formulation Example 5 Ingredients Disodium DL-Malate Sodium Chloride Magnesium Chloride 6H2O Calcium Chloride 2H20 Content (mg/ml) 0.37 6.38 0.21 0.19 Example 2 Preparation of Pharmaceutical Packaging Containing Blood Filtration or Dialysate of the Invention The following replenishing solution is prepared by using water for injection, respectively. The components in A and B are used to form replenishing solutions A and B, respectively. The conventional screening and filtration steps are separately filled into separate compartments or packages of a medical container. The containers are sterilized and 115206.doc -16-200906424 forms the blood filtration/dialysis fluid product of the present invention. The supplement B is added to the replenisher A at an appropriate timing and mixed to form the hemofiltration/dialysis solution of the present invention. 1 · Formulation Example 1 The components in the above Formulation Example 1 were separated into A and B sections as follows:

5L補充液A與200 mL補充液B 成分含量 (克/升）混合前濃度 (mM) 混合後濃度 mM 補充液A 氯化納 6.1358 104.99 100.95 氣化鎂· 6H20 0.2114 1.04 1.00 氣化鈣· 2H20 0.1911 1.30 1.25 乳酸鈉 0.9323 8.32 8.00 總計氯離子 109.67 105.45 補充液B 碳酸氫鈉 70.00 833.27 32.05 混合後各離子/根濃度(mM) 當量濃度(mEq) 鈉離子 141.00 141.00 鎮離子 1.00 2.00 約離子 1.25 2.50 氣離子 105.45 105.45 乳酸根 8 8.00 碳酸根 32.05 32.05 2.配方例2 將上述配方例2中之成份分開成A及B部分如下所示方式調配： 115206.doc -17- 200906424 5L補充液A與200 mL補充液⑴’昆合成分含量 (克/升）混合前濃度 (mM) 混合後濃度 mM 補充液A 氯化納 6.3486 108.63 104.45 氣化鎂· 6H20 0.2114 1.04 1.00 氣化鈣· 2H20 0.1911 1.30 1.25 檸檬酸鈉· 2H20 0.4703 1.46 1.41 總計氣離子 113.31 108.95 補充液B 碳酸氮納 70.00 833.27 32.05 混合後各離子/根濃度(mM) 當量濃度(mEq) 鈉離子 140.72 140.72 鎂離子 1.00 2.00 鈣離子 1.25 2.50 氯離子 108.95 108.95 檸檬酸根 1.41 4.22 碳酸根 32.05 32.05 3.配方例3 將上述配方例3中之成份分開成A及B部分如下所示方式調配： 5L補充液A與200 mL補充液丑混合成分含量 (克/升）混合前濃度 (mM) 混合後濃度 mM 補充液A 氯化納 6.3790 109.15 104.95 氣化鎂· 6H20 0.2114 1.04 1.00 氣化鈣· 2H20 0.1911 1.30 1.25 酒石酸納· 2H2O 0.4700 2.04 1.96 總計氣離子 113.83 109.45 補充液B 碳酸氣納 70.00 833.27 32.05 115206.doc -18- 200906424 混合後各離子/根濃度(mM) 當量濃度(mEq) 納離子 140.93 140.93 鎂離子 1.00 2.00 鈣離子 1.25 2.50 氯離子 109.45 109.45 酒石酸根 1.96 3.93 碳酸根 32.05 32.05 4.配方例4 將上述配方例4中之成份分開成A及B部分如下所示方式調配： 5L補充液A與200 mL補充液以昆合成分含量 (克/升）混合前濃度 (mM) 混合後濃度 mM 補充液A 氯化納 6.3790 109.15 104.95 氣化鎂· 6H20 0.2114 1.04 1.00 氯化鈣· 2H20 0.1911 1.30 1.25 琥珀酸鈉 0.3300 2.04 1.96 總計氣離子 113.83 109.45 補充液B 碳酸氫鈉 70.00 833.27 32.05 混合後各離子/根濃度 (mM) 當量濃度 (mEq) 納離子 140.92 .140.92 鎂離子 1.00 2.00 鈣離子 1.25 2.50 氯離子 109.45 109.45 琥珀酸根 1.96 3.92 碳酸根 32.05 32.05 115206.doc •19· 200906424 5.配方例5 將上述配方例5中之成份分開成A及B部分如下所示方式調配： 5L補充液A與200 mL補充液⑴昆合成分含量 (克/升）混合前濃度 (mM) 混合後濃度 mM 補充液A 氯化納 6.3790 109.15 104.95 氣化鎂· 6H20 0.2114 1.04 1.00 氣化鈣· 2H20 0.1911 1.30 1.25 蘋果酸鈉 0.3700 2.08 2.00 總計氯離子 113.83 109.45 補充液B 碳酸氫鈉 70.00 833.27 32.05 混合後各離子/根濃度 (mM) 當量濃度 (mEq) 納離子 141.0 141.0 鎂離子 1.00 2.00 鈣離子 1.25 2.50 氣離子 109.45 109.45 蘋果酸根 2.00 4.00 碳酸根 32.05 32.05 實例3 本發明血液過濾或透析液之沉澱試驗分別以注射用水調合補充液A及補充B中各成份，以分別形成補充液A及補充B。分別充填至一醫藥容器之不同隔間或包裝中。對該等容器形成本發明之血液過濾/透析液。將補充液B加至補充液A並混合均勻形成本發明血液 115206.doc -20· 200906424 過濾/透析液。將本發明血液過遽/透析液分別放置於室溫及41 C的恆·溫水槽，在不同的時間點以雷射散射粒徑分析儀（八111；〇111&^。卩&^1^6犷&183111卩1111§3}^6111111〇(161人？88-200- 21CFR11 , Particle Measuring Systems，USA)，分別測定不同放置條件血液過濾/透析液中的微粒子。配方例測定時間/ 試驗條件第0小時>25 μιη微粒子數第2小時>25 μηι微粒子數第4小時>25 μηι微粒子數第6小時>25 μηι微粒子數第24小時>25 μιη微粒子數 ” 室溫 0.00 0.00 0.00 0.13 0.00 41°C - 0.00 0.00 0.00 0.20 2a 室溫 0.00 0.00 0.00 0.00 0.00 41。。署 0.00 0.07 0.00 0.00 3b 室溫 <2.5 <2.0 < 1.5 <1.2 <1.5 41°C <1,4 <0.9 <1.0 <2.5 4b 室溫 <1.1 <1.0 <0.4 <0.2 <0.1 41°C - <0.9 <0.2 <0.1 <0.5 5b 室溫 <1.3 <0.7 <0.7 <0.5 0.00 41 °C - <0.7 <0.5 <0.7 <0.3 本發明發現不論在室溫或放置在41 °C的恆溫水槽中，粒徑大於25 μιη的微粒子數目都沒有增多的現象，顯示加入有機酸鹽，例如但不限於乳酸鹽、檸檬酸鹽、酒石酸鹽、玻ίέ酸鹽及類果酸鹽確貫能抑制本發明血液過濾、/透析液沉澱情形的產生。 -21 - 115206.doc5L Replenishing Solution A and 200 mL Replenishing Solution B Ingredient Content (g/L) Premixed Concentration (mM) Concentrated mM Replenisher A Chlorinated Na 6.1358 104.99 100.95 Magnesium Sulfide · 6H20 0.2114 1.04 1.00 Calcium Calcium · 2H20 0.1911 1.30 1.25 Sodium lactate 0.9323 8.32 8.00 Total chloride ion 109.67 105.45 Replenisher B Sodium bicarbonate 70.00 833.27 32.05 Ion/root concentration (mM) Equivalent concentration (mEq) after mixing Sodium ion 141.00 141.00 Town ion 1.00 2.00 Ion 1.25 2.50 Gas ion 105.45 105.45 Lactic acid 8 8.00 Carbonate 32.05 32.05 2. Formulation Example 2 The ingredients in the above formula 2 were separated into parts A and B as follows: 115206.doc -17- 200906424 5L replenishing solution A and 200 mL replenishing solution (1) 'Kun-synthesis content (g/L) Pre-mixing concentration (mM) Concentration after mixing mM Replenishing solution A Chlorinated sodium 6.3486 108.63 104.45 Magnesium vapor · 6H20 0.2114 1.04 1.00 Calcium carbide · 2H20 0.1911 1.30 1.25 Sodium citrate · 2H20 0.4703 1.46 1.41 Total gas ion 113.31 108.95 Replenishing solution B NbB 70.00 833.27 32.05 After mixing, each ion/root is concentrated Degree (mM) Equivalent Concentration (mEq) Sodium ion 140.72 140.72 Magnesium ion 1.00 2.00 Calcium ion 1.25 2.50 Chloride ion 108.95 108.95 Citrate 1.41 4.22 Carbonate 32.05 32.05 3. Formulation Example 3 The ingredients in Formulation 3 above were separated into A and Part B is formulated as follows: 5L replenisher A and 200 mL replenisher ugly mixed component content (g/l) Premixed concentration (mM) Concentrated concentration mM Replenisher A Chlorinated sodium 6.3790 109.15 104.95 Magnesium sulfide · 6H20 0.2114 1.04 1.00 Calcium Calcium · 2H20 0.1911 1.30 1.25 Natto-tartaric acid · 2H2O 0.4700 2.04 1.96 Total gas ion 113.83 109.45 Replenishing solution B Carbonation gas 70.00 833.27 32.05 115206.doc -18- 200906424 Ion/root concentration (mM) equivalent after mixing Concentration (mEq) Nano ion 140.93 140.93 Magnesium ion 1.00 2.00 Calcium ion 1.25 2.50 Chloride ion 109.45 109.45 Tartrate 1.96 3.93 Carbonate 32.05 32.05 4. Formulation Example 4 The components in the above formula 4 are separated into parts A and B as shown below. Mode preparation: 5L replenishing solution A and 200 mL replenishing solution are mixed with Kunming synthetic content (g/L) Concentration (mM) Concentration after mixing mM Replenisher A Chlorinated sodium 6.3790 109.15 104.95 Magnesium sulfide · 6H20 0.2114 1.04 1.00 Calcium chloride · 2H20 0.1911 1.30 1.25 Sodium succinate 0.3300 2.04 1.96 Total gas ion 113.83 109.45 Replenishing solution B Sodium bicarbonate 70.00 833.27 32.05 Ion/root concentration (mM) Equivalent concentration (mEq) after mixing. Nano ion 140.92 .140.92 Magnesium ion 1.00 2.00 Calcium ion 1.25 2.50 Chloride ion 109.45 109.45 Succinate 1.96 3.92 Carbonate 32.05 32.05 115206.doc •19· 200906424 5. Formulation Example 5 The components in the above Formulation Example 5 were separated into Parts A and B as follows: 5 L of Replenishing Solution A and 200 mL of Replenishing Solution (1) Ingredient Content (g/L) Concentration before Mixing (mM) After mixing, concentration mM Replenishing solution A Chlorinated sodium 6.3790 109.15 104.95 Magnesium sulfide · 6H20 0.2114 1.04 1.00 Calcium sulfide · 2H20 0.1911 1.30 1.25 Sodium malate 0.3700 2.08 2.00 Total chloride ion 113.83 109.45 Replenishing solution B Sodium bicarbonate 70.00 833.27 32.05 Mix After each ion/root concentration (mM) equivalent concentration (mEq) nano-ion 141.0 141.0 magnesium ion 1.00 2.00 Calcium ion 1.25 2.50 Gas ion 109.45 109.45 Malate 2.00 4.00 Carbonate 32.05 32.05 Example 3 Precipitation test of blood filtration or dialysate of the present invention The components of supplement A and B are respectively added with water for injection to form a replenishing solution, respectively. A and supplement B. Fill separately into separate compartments or packages of a medical container. These containers form the blood filtration/dialysis solution of the present invention. Replenisher B is added to replenisher A and mixed to form the blood of the invention 115206.doc -20· 200906424 Filtration/dialysis solution. The blood permeation/dialysis solution of the present invention was separately placed at room temperature and a constant temperature water tank of 41 C, and the laser scattering particle size analyzer was used at different time points (eight 111; 〇111 & ^. 卩 & ^1 ^6犷&183111卩1111§3}^6111111〇 (161 persons? 88-200-21CFR11, Particle Measuring Systems, USA), respectively, to determine the microparticles in the blood filtration/dialysis solution under different placement conditions. Test condition 0th hour> 25 μηη microparticle count 2nd hour> 25 μηι microparticle count 4th hour> 25 μηι microparticle count 6th hour> 25 μηι microparticle count 24th hour > 25 μιη microparticle count "room temperature 0.00 0.00 0.00 0.13 0.00 41°C - 0.00 0.00 0.00 0.20 2a Room Temperature 0.00 0.00 0.00 0.00 0.00 41. Department 0.00 0.07 0.00 0.00 3b Room Temperature <2.5 <2.0 < 1.5 <1.2 <1.5 41°C <1,4 <0.9 <1.0 <2.5 4b room temperature <1.1 <1.0 <0.4 <0.2 <0.1 <0.1 41°C - <0.9 <0.2 <0.1 <0.5 5b Room Temperature <1.3 <0.7 <0.7 <0.5 0.00 41 °C - <0.7 <0.5 <0.7 <0.7 <0.3 The present invention finds no It is placed in a constant temperature water bath at 41 °C, and the number of particles with a particle size larger than 25 μm is not increased. It shows the addition of organic acid salts such as, but not limited to, lactate, citrate, tartrate, and silicate. And the acid-like acid salt can inhibit the blood filtration and / dialysate precipitation of the present invention. -21 - 115206.doc

Claims

200906424 X. Patent application scope: a blood transfusion or dialysate, the composition thereof comprises a sodium salt or a hydrate thereof, a town & or a hydrate thereof, a feed salt or a hydrate thereof, and an organic acid salt or a hydrate thereof, wherein the organic The solubility product (Ksp) of the acid ion and the calcium ion is greater than 1 〇 9 (25 C ); the limiting condition is that when the organic acid is lactate, the concentration is less than 30 mmol/L. 2. The blood filtration or dialysate according to claim 1, wherein the sodium salt or a hydrate thereof is sodium carbonate, sodium hydrogencarbonate, sodium sulfate, sodium lactate, sodium citrate, sodium tartrate, sodium caterate, sodium malate, Or a hydrate thereof or a combination thereof, the magnesium salt or a hydrate thereof is magnesium gas, magnesium carbonate, magnesium sulfate, a hydrate thereof or a combination thereof; the calcium salt or a hydrate thereof is calcium carbonate, calcium gluconate, sulfuric acid mother, The hydrate thereof or a combination thereof; and the organic acid or the hydrate thereof are citrate, lactate, tartrate, succinate, malate, or a hydrate thereof or a combination thereof. 3. Blood filtration or dialysate according to claim 1 containing 〇.1-3.5 mg/1 sodium lactate, 4.0-7.5 mgA gasification sodium, 0.05-0.35 mg/1 magnesium chloride, 0.1-0.4 mg /1 of gasification mother and 0 - 5.5 mg / 1 sodium bicarbonate. 4. Blood filtration or dialysate according to claim 3, containing 0.3-2.5 sodium lactate, 4.5-6.5 mg/1 gasification sodium, 0.05-0.3 mg/1 magnesium carbide and 0.15-0.35 mg/1 Calcified calcium. 5. The blood sputum or dialysate according to claim 4, the composition comprising about 0.90 mg/1 sodium lactate, about 5.90 mg At sodium vaporization, about 0.20 magnesium sulfide, about 0.18 mg/1 calcium carbonate and about 2.69 mg/1 sodium bicarbonate. 115206.doc 200906424 6. The blood filtration or dialysate according to claim 1 comprising 〇_〇25-6.65 mg/丨 of sodium citrate hydrate, 4.75-7.00 mg/1 of sodium sulphate, 0.045-0.35 Mg/1 of magnesium gas, 0.13-0.37 mg/1 of calcium chloride and 〇_5.10 mg/l of sodium bicarbonate. 7. Blood filtration or dialysate according to claim 1 containing 0.07-0.60 mg/1 sodium citrate hydrate, 4.95-6.75 mg/1 sodium chloride, 0.075-0.30 mg/1 magnesium chloride and 0.15- 0.35 mg/1 of calcium carbonate. 8. The blood filtration or dialysate according to claim 1 which comprises about 〇, 43 mg/1 of citric acid dihydrate, about 6.35 mg/1 of sodium sulphate, about 0.21 mg/Ι of magnesium sulphate and About 0.19 mg / Torr of calcium chloride. 9. The blood filtration or dialysate according to claim 1, which comprises about 9.5 mg/1 sodium lactate, about 5.90 mg/1 sodium chloride, about 0.20 mg/1 magnesium chloride, about 0.18 mg/1. Gasification mother and about 2.69 mg / 1 of sodium bicarbonate. 10. The blood filtration or dialysate according to claim 1, which comprises about 43.43 mg/1 of tri-nanohydrate dihydrate, about 6.35 mg/1 of sodium chloride, and about 0.21 mg/1 of magnesiumated magnesia. And about 0.19 mg / Ι of gasified calcium. 11. The blood filtration or dialysate according to claim 1, which comprises nano ions: 125-150 mEq/L, magnesium ions: 0.50-3.0 mEq/L, calcium ions: 2.0-50 mEq/L, chloride ion: 90- 120 mEq/L, lactate and bicarbonate: less than 30 mEq/L. 12. Blood filtration or dialysate according to claim 1, which comprises sodium ions: about 141.00 mEq/L, magnesium ions: about 2.00 mEq/L, calcium ions: about 2.50 mEq/L, chloride ions: about 1 〇 5 μ mEq/L, lactate: about 8.00 mEq/L and carbonate: about 32.05 mEq/L. 115206.doc 200906424 13. The blood filtration or dialysate according to claim 1, which comprises sodium ions: about 140.72 mEq/L, magnesium ions: about 2.00 mEq/L, calcium ions: about 2.50 mEq/L, gas ions: about 108·95 mEq/L, citrate: about 4.22 mEq/L and carbonate: about 32.05 mEq/L. 14 · Blood perfusion or dialysate according to claim 1 'which contains steel ions: about 140.93 mEq/L, magnesium ion: about 2.00 mEq/L, | bow ion: about 2_50 mEq/L, chloride ion: about 109.45 mEq/L, tartrate: about 3.93 mEq/L and carbonate: about 32.05 mEq/L. 1 5. The blood filtration or dialysate according to claim 1, which comprises sodium ions: about 140.92 mEq/L, magnesium ions: about 2.00 mEq/L, calcium ions: about 2.5 0 mEq/L, gas ions: about 109.45 mEq /L 'succinate: about 3.92 mEq/L and carbonate: about 32.05 mEq/L. 16. The blood filtration or dialysate according to claim 1 which comprises sodium ions: about 141.0, magnesium ions: about 2.00 mEq/L, calcium ions: about 2.s〇mEq/L, gas ions: about 109.45 mEq/L , malate root: about 4.00 mEq / L and carbonate: about 32.05 mEq / L. 17. The blood filtration or dialysate of claim 2 wherein the sodium salt is sodium lactate, sodium tartrate, sodium citrate, sodium succinate, sodium malate, sodium hydrogencarbonate, or a hydrate thereof or a combination thereof. 18. The blood filtration or dialysate according to claim 2, wherein the magnesium salt is magnesium chloride or chaotic town 6H2O. 19. Blood filtration or dialysate according to claim 2 wherein the calcium salt is calcium carbonate or gasified word. 20. The blood filtration or dialysate according to claim 2, wherein the citrate or the Il5206.doc 200906424 hydrate is citric acid, citric acid hydrate, dihydrogen citrate m § ^. Trisodium sulphate, trisodium citrate dihydrate, uranium citrate = cesium potassium 'dipotassium hydrogen citrate, calcium citrate, magnesium citrate or its bismuth 21. Blood filtration or dialysate according to claim 2 Wherein the lactate hydrate is lactic acid 'sodium lactate, potassium lactate, calcium lactate, magnesium lactate trihydrate or a combination thereof. Q broad, 22. a pharmaceutical product comprising at least two compartments or separate packages, and the components comprising the blood filtration or dialysate of the invention are placed in the compartments or packages in different combinations, comprising calcium The salt compartment or package does not contain carbonate. 23. The pharmaceutical product according to claim 22, which has two compartments or a separate package 'one of the compartments or packages containing sodium bicarbonate' and another compartment or package containing sodium lactate (sodium citrate, sodium malate, tartaric acid) Sodium or sodium sulphate), sodium gasification, magnesium gasification and calcium carbonate. P24. The pharmaceutical product according to claim 22, which has two compartments or a separate package 'one of the compartments or packages containing sodium, magnesium chloride and calcium carbonate, and the other compartment or package containing sodium lactate (citric acid) Sodium, sodium malate, sodium tartrate or sodium citrate) and sodium bicarbonate. 25. The pharmaceutical product according to claim 22, which has two compartments or a separate package, wherein one compartment or package contains magnesium gasification and calcium carbonate, and the other compartment or package contains sodium chloride, sodium lactate (lemon Sodium, sodium malate, sodium tartrate or sodium succinate) and sodium bicarbonate. 26. The pharmaceutical product according to claim 22, which has two compartments or a separate package 115206.doc 200906424, wherein one compartment or package contains calcium carbonate, and the other compartment or package contains magnesium gasification, chlorination Sodium, sodium lactate (sodium citrate, sodium malate, sodium tartrate or sodium succinate) and sodium bicarbonate. 27. The pharmaceutical product according to claim 22, which has three compartments or a separate package, wherein one compartment or package contains sodium lactate (sodium citrate 'sodium malate, sodium tartrate or sodium succinate), a compartment or package Contains gasified sodium, magnesium chloride and calcium carbonate. And another compartment or package containing sodium bicarbonate. 28. The pharmaceutical product according to claim 22, which has three compartments or a separate package, wherein one compartment or package comprises sodium lactate (sodium citrate, sodium malate, sodium tartrate or sodium succinate), sodium sulphate, one The compartment or package contains magnesium chloride and calcium chloride and the other compartment or package contains sodium bicarbonate. 29. The pharmaceutical product according to claim 22, which has three compartments or a separate package, wherein one compartment or package contains sodium lactate (sodium citrate, sodium malate, sodium tartrate or sodium succinate) (sodium citrate, apple Sodium, sodium tartrate or sodium succinate), a compartment or package containing magnesium chloride and another compartment or package containing calcium carbonate. 3. A medical product according to claim 22, which has three compartments or a separate package 'one of the compartments or packages containing sodium lactate (sodium citrate, sodium malate, sodium tartrate or sodium succinate), one compartment The package or package contains magnesium carbide and gasification dance and another compartment or package containing sodium carbonate and sodium bicarbonate. 3 1. The pharmaceutical product according to claim 22, wherein the solution after mixing in each compartment or package comprises nano ions: Π 5-150 mEq/L, town ions: 0.50-3.0 mEq/L, strontium ions: 2.0-50 mEq/ L, gas ion: 90-120 mEq / L, lactate ion and bicarbonate ion: less than 3 〇 mEq / L. 115206.doc 200906424 32. The pharmaceutical product according to claim 22, wherein the solution after mixing in each compartment or package comprises sodium ions: about 141.00 mEq/L, magnesium ions: about 2.00 mEq/L, calcium ions: about 2.50 mEq/ L, gas ion: about 105.45 mEq / L, lactate: about 8.00 mEq / L and carbonate: about 32.05 mEq / L 〇 33. According to the medical product of claim 22, the solution after mixing each compartment or package contains Sodium ion: about 140.72 mEq/L, magnesium ion: about 2.00 mEq/L, calcium ion: about 2.50 mEq/L, gas ion: about 108.95 mEq/L, citrate: about 4.22 mEq/L and carbonate: about 32.05 mEq/L. 34. The pharmaceutical product according to claim 22, wherein the solution after mixing in each compartment or package comprises sodium ions: about 140.93 mEq/L, magnesium ions: about 2.00 mEq/L, calcium ions: about 2.50 mEq/L, chloride ions : about 109.45 mEq/L, tartrate: about 3.93 mEq/L and carbonate: about 32.05 mEq/L. 35. The pharmaceutical product according to claim 22, wherein the solution after mixing in each compartment or package comprises sodium ions: about 140.92 mEq/L, magnesium ions: about 2.00 mEq/L, calcium ions: about 2·50 mEq/L, Gas ion: about 109.45 mEq/L, succinate: about 3.92 mEq/L and carbonate: about 32.05 mEq/L. 36. The pharmaceutical product according to claim 22, wherein the solution after mixing in each compartment or package comprises sodium ions: about 141.0, magnesium ions: about 2.00 mEq/L, calcium ions: about 2.50 mEq/L, gas ions: about 109.45 mEq/L, malate root: about 4.00 mEq/L and carbonate: about 32.05 mEq/L. A blood filtration or dialysate according to any one of items 1 to 21, or a pharmaceutical product according to any one of claims 22 to 36, which may be in the form of a concentrate. 3. The blood filtration or dialysate or pharmaceutical product according to claim 37, wherein the concentration of each component of the concentrate is 1 to 4 times the original concentration. 39. The blood filtration or dialysate or medicinal product of claim 37, wherein the concentration of each component of the concentrate is from 12 to 1 times the original concentration. 40. The blood filtration or dialysate or medicinal product according to claim 37, wherein the concentration of each component of the concentrate is 2. 2 to 5 times the original concentration. 41. The blood transition or dialysate or medicinal product according to claim 37, wherein the concentration of each component of the concentrate is 1.2 to 3 times the original concentration. 42. The blood filtration or dialysate or pharmaceutical product according to claim 37, wherein the concentration of each component of the concentrate is 1.2 to 2 times the original concentration. 43. The blood filtration or dialysate or medicinal product according to claim 37, wherein the concentration of each component of the concentrate is from 1.2 to 1.75 times the original concentration. 44. The blood filtration or dialysate or medicinal product according to claim 37, wherein the concentration of each component of the concentrate is 1.2 to 1.5 times the original concentration. Li5206.doc 200906424 VII. Designation of representative drawings: (1) The representative representative of the case is: (none) (2) The symbol of the symbol of the representative figure is simple: 〇8. If there is a chemical formula in this case, please reveal the characteristics that can best show the invention. Chemical formula: (none) I15206.doc