CN1242747C - Compound baking soda injection and its preparation - Google Patents
Compound baking soda injection and its preparation Download PDFInfo
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- CN1242747C CN1242747C CN 03133947 CN03133947A CN1242747C CN 1242747 C CN1242747 C CN 1242747C CN 03133947 CN03133947 CN 03133947 CN 03133947 A CN03133947 A CN 03133947A CN 1242747 C CN1242747 C CN 1242747C
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Abstract
The present invention relates to a compound sodium bicarbonate injection which is medicine for clinically treating organism acid-base unbalance caused or finally caused by various diseases. The present invention is composed of the following components with the proportion by weight: 1 portion of sodium bicarbonate and 2 to 3 portions of tris trisaminomethane. The pH value of tris trisaminomethane solution which is completely dissolved is titrated to be 8.2 to 9.0 by a micro amount of hydrochloric acid. A solvent is distilled water. The present invention has the obvious effects that lactic acid accumulated in a body can be effectively converted (under the state of a pathological mechanism); sufficient extrinsic hydrocarbonate can be effectively provided; acidosis in cells can be effectively corrected; alkalosis (alkaline excess) in cells is not caused; the compound sodium bicarbonate injection is infused via veins without stimulating blood vessel endothelium or causing intravascular thrombosis; the oxygen partial pressure of arterial blood and venous blood and the partial pressure of carbon dioxide can be kept normal; a plasma osmotic pressure is not affected.
Description
Technical field
The present invention relates to a kind of Sodamint injection and preparation method thereof, belong to alkaline buffer, is the medicine that all multiple diseases of clinical treatment cause or finally cause body acid-base unbalance (metabolic acidosis).Alkaline buffer rescues at various emergency and severe diseases, various heavy danger shocks, and clinical multiple organ failure, MOF, organ transplantation, the cardiovascular major operation in cardio-pulmonary-cerebral resuscitation, is an extremely important medicine for treatment particularly.
Background technology
Twentieth century begins using basic buffer sodium bicarbonate (NAHCO3) fifties clinically.Twentieth century clinical three (methylol) aminomethane (THAM) that the occurred sixties.Because these medicines exist the serious effect of paying, and make the application clinically of these medicines be restricted.After the sodium bicarbonate intravenous injection, cause that patient artery blood partial pressure of carbon dioxide increases.Clinical treatment pulmonary heart disease patient Shi Ke further aggravates patient's dyspnea, often calls together to disastrous effect.Because carbon dioxide very easily permeate through cell membranes enters in the cell, intracellular pH value is reduced.Therefore, a large amount of use of Chang Fanfu and therapeutic effect is not good finally causes oxygen dissociation curve to move to left clinically, increases the weight of the histiocyte anoxia.Owing to widely apply repeatedly, cause patient's blood sodium to raise, plasma osmotic pressure increases, and finally causes cerebral hemorrhage.The subject matter that Trisaminomethane exists is to cause after the intravenous injection that patient respiration stops, patient's tracheal intubation that often need walk rapidly.Because its alkalescence is very strong,, outside blood vessel, both caused tissue necrosis if leak to ooze except blood glucose and blood calcium influence are made it more greatly often to cause thrombosis in phlebitis and the blood vessel the reduction.Therefore abroad limited or stopped this two kinds of medicine uses clinically.And we domestic at present in the medical institutions of the different levels in each large, medium and small city still with sodium bicarbonate as the unique selection medication.
Twentieth century eighties, the external succedaneum that sodium bicarbonate and Trisaminomethane have successively occurred comprises CARBICARB and TRIBONATE. by contrast, high praise that is subjected to the clinician clinically and the welcome abroad of this medicine of TRIBONATE.But because it can not improve intracellular pH value effectively, can not correct intracellular acidosis effectively, in the patient of clinical cardio-pulmonary-cerebral resuscitation treatment, still not see therapeutical effect effectively.The clinical pharmacology problem of its existence remains further to be solved.
Summary of the invention
The invention provides a kind of Sodamint injection and preparation method thereof, be on the basis of clinical and experiment basis theoretical research for many years, and after the actual clinical pharmacological action research fully and evaluation to alkaline buffer, restudy the more efficiently alkaline buffer that more meets the organism metabolism needs that is combined into.
Sodamint injection of the present invention is made of by weight following component:
Sodium bicarbonate: Trisaminomethane :=1: (2-3);
The hydrochloric acid trace is titrated to 8.2-9.0 with the pH value of consoluet Trisaminomethane solution;
Solvent is a distilled water.
Preparation method of the present invention comprises the steps:
(1) gets the Trisaminomethane powder by above-mentioned weight ratio, add the distilled water that accounts for total solution 75%, get consoluet Trisaminomethane solution for later use;
(2) get micro-hydrochloric acid the pH value of consoluet Trisaminomethane solution is titrated to 8.2-9.0;
(3) get the sodium bicarbonate powder by above-mentioned weight ratio, add the distilled water that accounts for total solution 18%, it is stand-by to get consoluet sodium bicarbonate solution;
(4) consoluet sodium bicarbonate solution is sneaked in the Trisaminomethane solution that PH is 8.2-9.0.
(5) with distilled water the solution total amount is added into 100%.
(6) with mixed liquid filtering, packing, after the sealing, sterilization gets final product.
Physicochemical property of the present invention:
(1) osmotic pressure: the 385-685 milliosmolarity/liter; (2) PH:8.2-9.0.
The clinical pharmacology effect that Sodamint injection of the present invention is possessed is desirable more complete.Its remarkable result is: it can transform the lactic acid of (under the strong state of pathology) body accumulation effectively (1).(2) it can provide enough exogenous bicarbonates effectively.(3) it can correct intracellular acidosis effectively.(4) it does not cause intracellular alkalosis (base excess).(5) through venoclysis, it does not stimulate blood vessel endothelium, does not cause thrombosis in the blood vessel.(6) it can keep the arteriovenous blood oxygen pressure, and partial pressure of carbon dioxide is normal.(7) it does not influence plasma osmotic pressure.
The specific embodiment
Embodiment 1:
Sodamint injection of the present invention is made of by weight following component:
Sodium bicarbonate: Trisaminomethane=1: 2
Preparation method of the present invention comprises the steps:
(1) gets three (methylol) aminomethane (THAM) powder 200kg by above-mentioned weight ratio, add the distilled water that accounts for total solution 75%, get consoluet Trisaminomethane solution for later use;
(2) get micro-hydrochloric acid the pH value of consoluet Trisaminomethane solution is titrated to 8.2;
(3) get sodium bicarbonate (NAHCO3) powder 100kg by above-mentioned weight ratio, add the distilled water that accounts for total solution 18%, it is stand-by to dissolve sodium bicarbonate solution fully;
(4) consoluet sodium bicarbonate solution being sneaked into PH is in 8.2 the Trisaminomethane solution.
(5) with distilled water the solution total amount is added into 100%.
(6) with mixed liquid filtering, packing, after the sealing, temperature is 115 ℃, autoclaving 30 minutes.
Embodiment 2:
Sodamint injection of the present invention is made of by weight following component:
Sodium bicarbonate: Trisaminomethane=1: 3
Preparation method of the present invention comprises the steps:
(1) gets Trisaminomethane powder 300kg by above-mentioned weight ratio, add the distilled water that accounts for total solution 75%, get consoluet Trisaminomethane solution for later use;
(2) get micro-hydrochloric acid the pH value of consoluet Trisaminomethane solution is titrated to 9.0;
(3) get sodium bicarbonate powder 100kg by above-mentioned weight ratio, add the distilled water that accounts for total solution 18%, it is stand-by to dissolve sodium bicarbonate solution fully;
(4) consoluet sodium bicarbonate solution being sneaked into PH is in 9.0 the Trisaminomethane solution.
(5) with distilled water the solution total amount is added into 100%.
(6) with mixed liquid filtering, packing, after the sealing, temperature is 115 ℃, autoclaving 30 minutes.
Embodiment 3:
Sodamint injection of the present invention is made of by weight following component:
Sodium bicarbonate: Trisaminomethane=1: 2.5
Preparation method of the present invention comprises the steps:
(1) gets Trisaminomethane powder 250kg by above-mentioned weight ratio, add the distilled water that accounts for total solution 75%, get consoluet Trisaminomethane solution for later use;
(2) get micro-hydrochloric acid the pH value of consoluet Trisaminomethane solution is titrated to 8.6;
(3) get sodium bicarbonate powder 100kg by above-mentioned weight ratio, add the distilled water that accounts for total solution 18%, it is stand-by to dissolve sodium bicarbonate solution fully;
(4) consoluet sodium bicarbonate solution being sneaked into PH is in 8.6 the Trisaminomethane solution.
(5) with distilled water the solution total amount is added into 100%.
(6) with mixed liquid filtering, packing, after the sealing, temperature is 115 ℃, autoclaving 30 minutes.
Embodiment 4:
Experimental technique of the present invention: PH De Measuring is fixed in the cell.
(1) gets normal person's venous blood and heparinization.
(2) equivalent heparinization blood is mixed with the equivalent phosphate buffer.
(3) get 10ml and fill 2.5ml Ficoll-Isopaque test tube, slowly inject the blood after diluting.With 2500 rev/mins centrifugal 20 minutes, extract human lymphocyte.
(4) lymphocyte that extracts is suspended in 37 ℃, PH7.40 contains in the HEPES buffer of BCECF-AM of 1 μ M concentration, slightly shakes 30 minutes.
(5) with PH in the fluorescent spectrophotometer assay cell.
Experimental result of the present invention: see Table (1)-(3)
Table (1) cell experiment solution PH 7.40
| Buffer | Microlitre | The example number | Phi in the initial cell | Δ PHi after the notes buffer | Annotate back 10 minutes Δ PHi | The outer PHe of initial cell | Annotate buffer Δ PHe | Annotate back 10 minutes Δ PHi/ Δ PHe |
| Tribonate | 10 20 40 200 | 9 10 12 4 | 7.05 the scholar 0.053 7.02 ± 0.051 7.02 ± 0.020 7.08 ± 0.013 | -0.017±0.011 -0.045±0.014 -0.050±0.008 -0.087±0.018 | -0.038 ± 0.025-0.071 scholar 0.021 0.032 ± 0.005 0.038 ± 0.009 | 7.25±0.004 7.25±0.006 7.32±0.020 7.42±0.005 | 0.020±0.005 0.036±0.006 0.073±0.008 0.180±0.000 | -0.505±1.336 -2.791±1.587 0.458±0.147 0.139±0.083 |
| NaHCO3 | 10 20 40 200 | 7 8 14 2 | 7.04±0.022 7.05±0.027 7.04±0.027 7.08±0.015 | 0.007±0.013 -0.034±0.014 -0.071±0.017 -0.205±0.025 | 0.010±0.025 -0.013±0.021 0.052±0.017 -0.080+0.020 | 7.29 the scholar 0.005 7.25 ± 0.012 7.27 ± 0.011 7.41 ± 0.010 | 0.043±0.009 0.055±0.010 0.120±0.015 0.205±0.015 | 0.048±0.753 -0.565±0.480 0.620±0.270 -0.385±0.069 |
| Sodamint | 10 20 40 200 | 9 10 8 6 | 7.05±0.028 7.01±0.016 7.02±0.026 7.04±0.033 | 0.021 the scholar 0.018 0.033 ± 0.020 0.060 ± 0.017 0.109 ± 0.019 | 0.002±0.011 0.091±0.021 0.103±0.018 0.406±0.018 | 7.25 scholar 0.003 7.26 ± 0.010 7.29 ± 0.010 7.42 ± 0.012. | 0.022±0.006 0.050±0.008 0.172±0.008 0.606±0.004 | -0.031±0.120 0.296±0.062 0.328+0.062 0.202 0.068 |
| Carbicarb | 10 20 40 200 | 11 9 11 5 | 7.00±0.033 6.89±0.024 7.04±0.039 7.02±0.091 | 0.001±0.010 0.036+0.014 0.175±0.021 1.228±0.347 | -0.003±0.021 0.112±0.017 0.291±0.018 0.742±0.010 | 7.25±0.007 7.25±0.008 7.29±0.023 7.43±0.017 | 0.143±0.006 0.283±0.007 0.598±0.018 2.105±0.036 | -0.016±0.149 0.4084±0.073 0.4934±0.037 0.3704±0.053 |
Table (2) cell experiment solution PH 7.40.Additional sodium acetate.
| Buffer | Microlitre | The example number | Phi in the initial cell | Annotate sodium acetate Δ PHi | Δ PHi after the notes buffer | Annotate back 10 minutes Δ PHi | The outer PHe of initial cell | Annotate buffer Δ PHe | Annotate back 10 minutes Δ PHi/ Δ PHe |
| Tribonate | 40 80 | 3 5 | 7.00±0.070 7.08±0.032 | -0.260 soil 0.044-0.280 ± 0.017 | -0.013±0.023 -0.014±0.007 | 0.070±0.025 0.180±0.084 | 7.30±0.049 7.34±0.025 | 0.080±0.015 0.086±0.017 | 0.800±0.200 2.407±0.421 |
| NaHCO3 | 40 80 | 3 5 | 7.08±0.030 7.06±0.018 | -0.280 ± 0.012-0.258 scholar 0.022 | -0.070 ± 0.021-0.100 scholar 0.014 | 0.193 soil 0.013 0.258 ± 0.018 | 7.36±0.015 7.37±0.042 | 0.093±0.003 0.130±0.021 | 2.081±0.190 2.001±0.403 |
| Sodamint | 40 80 | 4 5 | 7.06±0.028 7.08±0.028 | -0.267±0.012 -0.249±0.018 | 0.118±0.039 0.237±0.035 | 0.236±0.030 0.404±0.034 | 7.35±0.038 7.36±0.022 | 0.322±0.015 0.688±0.018 | 0.366±0.143 0.401±0.042 |
| CaTbicarb | 40 80 | 6 4 | 7.00±0.036 7.10±0.026 | -0.227±0.023 -0.255±0.023 | 0.205±0.046 0.308±0.047 | 0.313±0.046 0.658±0.038 | 7.36 ± 0.032 7.35 soil 0.015 | 0.542 the scholar 0.017 1.347 ± 0.018 | 0.547±0.075 0.489±0.032 |
Table (3) cell experiment solution PH 6.80.
| Buffer | Microlitre | The example number | Acidify | PHi in the initial cell | Annotate buffer Δ PHi | Annotate 10 minutes Δ PHi of buffer | The outer PHe of initial cell | Annotate buffer Δ PHe | Annotate the slow 10 minutes Δ PHi/ Δ PHe in back |
| Tribonate | 40 80 | 3 5 | PH6.80 PH6.80 | 6.94±0.0255 6.95±0.046 | -0.117±0.012 -0.207±0.026 | -0.080±0.011 -0.173±0.0087 | 6.78±0.013 6.64±0.120 | 0.215±0.022 0.480±0.108 | -0.402 scholar 0.101-0.473 ± 0.061 |
| NaHCO3 | 40 80 | 3 5 | PH6.80 PH6.80 | 6.91±0.043 6.89±0.025 | -0.287±0.020 -0.290±0.033 | -0.070±0.006 0.040±0.013 | 6.77±0.012 6.77±0.011 | 0.213±0.007 0.412±0.011 | -0.330±0.037 0.097±0.032 |
| Sodamint | 40 80 | 4 5 | PH6.80 PH6.80 | 6.90±0.041 6.89±0.026 | -0.062±0.032 0.196±0.0226 | 0.068±0.039 0.302±0.035 | 6.76±0.030 6.75±0.034 | 0.307±0.067 0.721±0.063 | 0.089 soil 0.032 0.296 ± 0.012 |
| Carbicarb | 4 80 | 7 3 | PH6.80 PH6.80 | 6.89±0.047 6.86±0.015 | -0.017±0.041 0.320±0.023 | 0.110±0.040 0.530±0.033 | 6.72±0.020 6.73±0.031 | 0.789±0.072 1.087±0.061 | 0.127±0.048 0.484±0.004 |
The experiment condition of table (1) experimental and control group: human lymphocyte, experimental cell solution PH 7.40.
The experiment condition of table (2) experimental and control group: human lymphocyte, experimental cell solution PH 7.40.Additional sodium acetate.
The experiment condition of table (3) experimental and control group: human lymphocyte, experimental cell solution PH 6.80.
Experimental result of the present invention is the following several problems of proof further:
(1) about pH value in effective raising cell
TRIBONATE is similar to the effect of NAHCO3.TRIBONATE under the experiment condition can not effectively promote PH in the cell, and our observed here result is with clinical to carry out that cardio-pulmonary-cerebral resuscitation treats with the viewed result of TRIBONATE be consistent.The viewed result of CARBICARB also is consistent with the high strong basicity that it is showed clinically.
(2) about Sodamint injection of the present invention
The experimental result that Sodamint injection of the present invention is obtained under identical experiment condition is gratifying.It can effectively improve, and PH replacement TRIBONATE can overcome the interior excessively alkali of cell (alkalosis in the cell) that CARBICARB causes again in the cell.
Claims (2)
1. Sodamint injection, it is characterized in that it by following component by weight forming:
Sodium bicarbonate: Tris :=1: 2-3;
The hydrochloric acid trace is titrated to 8.2-9.0 with the pH value of consoluet tris solution;
Solvent is a distilled water.
2. the preparation method of Sodamint injection according to claim 1 is characterized in that it comprises the steps:
(1) get the Tris powder by above-mentioned weight ratio, add the distilled water that accounts for total solution 75%, it is stand-by to get consoluet tris solution;
(2) get micro-hydrochloric acid the pH value of consoluet tris solution is titrated to 8.2-9.0;
(3) get the sodium bicarbonate powder by above-mentioned weight ratio, add the distilled water that accounts for total solution 18%, it is stand-by to dissolve sodium bicarbonate solution fully;
(4) consoluet sodium bicarbonate solution is sneaked in the tris solution that PH is 8.2-9.0;
(5) with distilled water the solution total amount is added into 100%;
(6) with mixed liquid filtering, packing, after the sealing, sterilization gets final product.
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|---|---|---|---|
| CN 03133947 CN1242747C (en) | 2003-09-11 | 2003-09-11 | Compound baking soda injection and its preparation |
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| CN 03133947 CN1242747C (en) | 2003-09-11 | 2003-09-11 | Compound baking soda injection and its preparation |
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| CN1242747C true CN1242747C (en) | 2006-02-22 |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102727517B (en) * | 2012-07-13 | 2013-07-03 | 李玉才 | Compound sodium bicarbonate injection and preparation method thereof |
| CN103800285B (en) * | 2012-11-06 | 2016-06-22 | 四川科伦药业股份有限公司 | A kind of sodium bicarbonate injection and preparation method thereof |
| CN104586885A (en) * | 2015-02-06 | 2015-05-06 | 河北天成药业股份有限公司 | Compound sodium bicarbonate electrolyte injection composition and preparation method thereof |
| WO2017192077A1 (en) * | 2016-05-03 | 2017-11-09 | Maquet Critical Care Ab | Capnotracking of cardiac output or effective pulmonary blood floow during mechanical ventilation |
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