CN100336829C - Carboxymethyl starch sodium preparation, preparing process and use thereof - Google Patents
Carboxymethyl starch sodium preparation, preparing process and use thereof Download PDFInfo
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- CN100336829C CN100336829C CNB031155243A CN03115524A CN100336829C CN 100336829 C CN100336829 C CN 100336829C CN B031155243 A CNB031155243 A CN B031155243A CN 03115524 A CN03115524 A CN 03115524A CN 100336829 C CN100336829 C CN 100336829C
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- starch glycolate
- sodium starch
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- distilled water
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Abstract
The present invention relates to a preparation containing carboxymethyl starch sodium with the molecular weight of 5, 000 to 15, 000 and a carboxymethyl substitution value of 0.1 to 1.0, and a preparing process and the use thereof. The preparation can be powder or an injection. The preparation of the present invention has a whole blood primary function and can treat hemorrhagic shock. The preparation can separate the red blood cell preserved at low temperature, the stem cell in the marrow and the white cell in blood. A separation rate of the white cell is 91%, and a separation rate of the blood platelet is 93%. A lower layer is the red blood cell, and the preparation can be used for treating a chemotherapy and radiotherapy patient with cancer and a patient with anemia.
Description
Technical field
The present invention relates to a kind of carboxymethyl starch sodium preparation, manufacture method and application thereof
Background technology
People's blood is not only costliness in the contemporary medical science, and is in short supply.Therefore all seeking a kind of method the countries in the world scientist with whole blood function and separating blood.
The function of the plasma substitute of research has only medium molecular dextran and middle molecular ethoxyl starch at present.Can only improve the molten amount of blood.Separating whole blood has only high molecular dextran dialogue cellular segregation rate 56%, and thrombocyte separation rate 53%, input human body can cause hemodynamic change and mix blood and change and anaphylaxis.Therefore the value that does not have application clinically.And polymer hydroxyethylamyle dialogue cellular segregation rate 74%, thrombocyte separation rate 64% not only costs an arm and a leg behind the human body but also be 48 days biological half-life but import, and can not reuse in a short time.
Summary of the invention
The purpose of this invention is to provide a kind of carboxymethyl starch sodium preparation.
The manufacture method that the purpose of this invention is to provide a kind of carboxymethyl starch sodium preparation.
The purposes that the purpose of this invention is to provide a kind of carboxymethyl starch sodium preparation.
Carboxymethyl starch sodium preparation of the present invention is to contain sodium starch glycolate, also contain physiological saline in case of necessity, perhaps also contain sodium-chlor, glucose and distilled water, the weight ratio of sodium starch glycolate, physiological saline, sodium-chlor, glucose and distilled water is 1: 0～50: 0～0.4: 0～5: 0～50, in other words, can be the sodium starch glycolate pulvis; The injection that carboxymethyl starch is received and physiological saline is formed, perhaps be dehydrated into pulvis again, form pulvis by carboxymethyl starch, sodium-chlor and glucose, as the injection of forming by the material of following weight ratio: sodium starch glycolate 1～15%, sodium-chlor 0.1～1.5%, glucose 0～10%, all the other are distilled water; Perhaps be dehydrated into pulvis again; This pulvis and distilled water are injection after mixing with 1: 30 weight ratio.The molecular weight of described carboxymethyl starch is 0.5 ten thousand～150,000, and the substitution value of carboxymethyl is 0.1～1.0.
The manufacture method of carboxymethyl starch sodium preparation of the present invention is as follows;
With molecular weight is 0.5 ten thousand～150,000, and the substitution value of carboxymethyl is that 0.1～1.0 sodium starch glycolate adds distilled water through purifying treatment, and spraying drying or frost drying are made pulvis.Further above-mentioned sodium starch glycolate and distilled water weight ratio are respectively 1～50 and 50～99, stir evenly through 90 ℃～150 ℃ spraying dryings or-0 ℃～60 ℃ lyophilizes, pulvis.Can add sterile saline during use.
Perhaps above-mentioned sodium starch glycolate is added sodium-chlor, glucose and distilled water, make injection through purifying treatment, spray-dried again or frost drying becomes pulvis, specifically will assign the material of weight percent: sodium starch glycolate 1～15%, sodium-chlor 0.1～1.5%, glucose 10% and activated carbon 0.2～2.5%, all the other are distilled water.Mix rear decoloring, bleaching temperature is 80 ℃～120 ℃, and the time is 15 minutes～200 minutes, filters, and preferably again through the millipore filtration sterilization, makes the aqua sterilisa injection.Described filtration is that Plate Filtration, husky rod filter or millipore filtration.Above-mentioned aqueous injection through above method spraying drying and frost drying pulvis.Add sterile purified water during use.
The above-mentioned preparation of sodium starch glycolate of the present invention can be used for artificial blood or blood cell separating agent.
In the venereal disease people that loses blood, not only improve the molten amount of blood, and can make red corpuscle in the blood of human body circulation.Under identical oxygen partial pressure, can discharge the effect of oxygen more.Even cause oxygenate more insufficient in the faint grade of respiration cycle, as just transferring under the condition of g at P02260nm, preparation of the present invention still can make oxyphorase discharge 7.5% oxygen more.Promptly can improve the molten amount of blood, can make the oxyphorase in the red corpuscle discharge functions such as oxygen more again.Therefore the present invention can replace the major function of whole blood, claims artificial blood.
The above-mentioned preparation of sodium starch glycolate of the present invention can separate the cryopreservation red corpuscle and wash, and stem cell (white corpuscle) and white corpuscle, thrombocyte and the red corpuscle in the human whole blood that can separate again among the human bone marrow separate.Can be used for the treatment of anaemia and battlefield and rescue the wounded.The ratio 0.3～2: 1 of liquid drugs injection dosage of the present invention and blood.
The above-mentioned preparation of sodium starch glycolate of the present invention can separate human bone marrow's stem cell and clean, the treatment leukemia.
The above-mentioned preparation of sodium starch glycolate of the present invention can also separate fresh blood, and the upper strata is that white corpuscle separates government official 91% and thrombocyte separation rate 93%.The cancer patient of treatment radiation and chemotherapy.The red corpuscle treatment anaemia patient of lower floor.And be 3 days biological half-life, therefore can reuse.
The above-mentioned preparation of sodium starch glycolate of the present invention has the blood group of being regardless of, and does not pollute, and is not safe in utilization, low price, and economic benefit is obviously and the advantage of obvious social benefit.
Description of drawings
Fig. 1 is that carboxymethyl starch sodium preparation of the present invention is to the hemoglobin oxygen affinity
A among the figure: whole blood; The b group: 70% whole blood adds 30% injection of the present invention; The c group is control group: 70% whole blood adds 30% medium molecular dextran.Abscissa PO
2(mmHg) be oxygen partial pressure, ordinate SaO
2The oxygen that discharges for oxyphorase.
Embodiment
To help to understand the present invention by following embodiment, but not limit content of the present invention.
Embodiment 1
With molecular weight is 0.5 ten thousand～150,000, and the substitution value of carboxymethyl is 2 kilograms of 0.1～1.0 sodium starch glycolatees, 0.2 kilogram in sodium-chlor, 47.5 kilograms of 0.3 kilogram of glucose and distilled water add 0.1 kilogram of activated carbon, mix, be warmed to 90 ℃, 30 minutes time, decolour, filter, aqueous injection is made in sterilization after millipore filtration again, liquid drugs injection is through 110 ℃ of spraying dryings or-50 ℃ of frost dryings, pulvis, this pulvis adds sterile purified water when using.
Embodiment 2
Taking by weighing molecular weight is 0.5 ten thousand～150,000, and the substitution value of carboxymethyl is 47 kilograms of 3 kilograms of 0.1～1.0 sodium starch glycolatees and distilled water, stir evenly through 110 ℃ of spraying dryings, or-50 ℃ of frost dryings pulvis.This pulvis adds sterile purified water when using.
Embodiment 3
Taking by weighing molecular weight is 0.5 ten thousand～150,000, and the substitution value of carboxymethyl is 47 kilograms in 3 kilograms of 0.1～1.0 sodium starch glycolatees and a physiological saline, stir evenly through 110 ℃ of spraying dryings, or-50 ℃ of frost dryings pulvis.This pulvis adds sterile purified water when using.
Embodiment 4
Taking by weighing molecular weight is 0.5 ten thousand～150,000, the substitution value of carboxymethyl is 47 kilograms of 0.1～1.0 0.2 kilogram in 2 kilograms of sodium starch glycolatees, sodium-chlor and distilled water, add 0.1 kilogram of activated carbon, mix, be warmed to 90 ℃, 30 minutes time, decolour, filter, through 110 ℃ of spraying dryings, or-50 ℃ of frost dryings pulvis.This pulvis adds sterile purified water when using.
Embodiment 5
The injection and the medium molecular dextran of embodiment 2,3 or 4 are seen accompanying drawing 1 to the influence of hemoglobin oxygen affinity.Wherein a organizes: whole blood, and the b group: 70% whole blood adds 30% injection of the present invention, and the c group is control group: 70% whole blood adds 30% medium molecular dextran.
The dissociation curve result of oxygen shows: b group is to the para-curve of a group statistics P＜0.01 that moves to right, and the two oxygen is separated P
50Value difference is not fairly obvious.C group is to the para-curve of a group statistics P＜0.015 that moves to left, and it is not obvious that the two oxygen is separated the P50 value difference.Illustrate that the preparation of helping methyl starch sodium of the present invention has the function that obviously makes the more release oxygen of oxyphorase, can be used for artificial blood.
Embodiment 6
Sodium starch glycolate of the present invention and high molecular dextran are to the influence of separation of whole blood.
Adopt two groups of tests, every group of six test tubes, every in vitro adds a certain amount of whole blood.One group of injection that adds embodiment 1,2,3 or 4, another group adds high molecular dextran.Whole blood is 1: 1 with the reagent ratio.Standing separation behind mixing is measured two layers blood ingredient up and down respectively.The result shows that the leukocytic separation rate of preparation of the present invention is 91%, thrombocyte separation rate 93%.And the leukocytic separation rate of control group is 56, thrombocyte separation rate 53%.
Claims (8)
1. the preparation of a sodium starch glycolate, the molecular weight of described sodium starch glycolate is 0.5 ten thousand～150,000, the substitution value of carboxymethyl is 0.1～1.0, also contains physiological saline in case of necessity, perhaps also contains sodium-chlor, glucose and distilled water; The weight ratio of described sodium starch glycolate, physiological saline, sodium-chlor, glucose and distilled water is 1: 0～50: 0～0.4: 0～5: 0～50.
2. the preparation of a kind of sodium starch glycolate as claimed in claim 1, it is characterized by said preparation is the pulvis of above-mentioned sodium starch glycolate, perhaps adds the injection of physiological saline again, the weight ratio of described pulvis and physiological saline is 1: 10～50.
3. the preparation of a kind of sodium starch glycolate as claimed in claim 1 is characterized by the injection that said preparation is made up of the following substances weight ratio: sodium starch glycolate 1～15%, and sodium-chlor 0.1～1.5%, glucose 0～10%, all the other are distilled water; Perhaps dehydration is pulvis.
4. the manufacture method of sodium starch glycolate as claimed in claim 1 is characterized in that being made respectively by following method:
(1) sodium starch glycolate adds distilled water through purifying treatment, through 90 ℃～110 ℃ spraying dryings or-10 ℃～-60 ℃ frost dryings, pulvis, the weight ratio of described sodium starch glycolate and distilled water is 1～50: 50～99;
(2) sodium starch glycolate, sodium-chlor, glucose, gac and distilled water are mixed, the decolouring of heating, filter, sterilize into injection, wherein the weight percent of sodium starch glycolate, sodium-chlor, glucose and gac is 1～15%, 0.1～1.5%, 0～10% and 0.2～2.5%, and all the other are distilled water;
(3) with the spray-dried and frost drying of (2) described injection, make pulvis;
Above-mentioned sodium starch glycolate molecular weight is 0.5 ten thousand～150,000, and the substitution value of carboxymethyl is 0.1～1.0.
5. the manufacture method of sodium starch glycolate as claimed in claim 4, the filtration that it is characterized in that described method (2) are that Plate Filtration, husky rod filter or millipore filtration.
6. the manufacture method of sodium starch glycolate as claimed in claim 4 is characterized in that bleaching time is 15～200 minutes in the described method (2), and temperature is 80 ℃～120 ℃.
7. the purposes of sodium starch glycolate as claimed in claim 1, it is characterized in that being used for improving the molten amount of blood and make red corpuscle in vivo blood circulation discharge the artificial blood or the blood cell separating agent of oxygen more.
8. the purposes of sodium starch glycolate as claimed in claim 7 is characterized in that described blood cell separating agent is that red corpuscle, the stem cell that separates marrow or the red corpuscle in the whole blood that is used for separating with cleaning cryopreservation separates with hematoblastic with white corpuscle.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB031155243A CN100336829C (en) | 2003-02-26 | 2003-02-26 | Carboxymethyl starch sodium preparation, preparing process and use thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB031155243A CN100336829C (en) | 2003-02-26 | 2003-02-26 | Carboxymethyl starch sodium preparation, preparing process and use thereof |
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| Publication Number | Publication Date |
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| CN1451667A CN1451667A (en) | 2003-10-29 |
| CN100336829C true CN100336829C (en) | 2007-09-12 |
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| Application Number | Title | Priority Date | Filing Date |
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| CNB031155243A Expired - Fee Related CN100336829C (en) | 2003-02-26 | 2003-02-26 | Carboxymethyl starch sodium preparation, preparing process and use thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2203053B1 (en) | 2008-01-14 | 2017-09-20 | Xin Ji | Modified starch material of biocompatible hemostasis |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108498879B (en) | 2017-02-28 | 2021-12-28 | 苏州安德佳生物科技有限公司 | Composition and reagent combination for submucosal injection and application thereof |
| CN110025821A (en) | 2018-01-12 | 2019-07-19 | 北京环球利康科技有限公司 | Use the method for biocompatible hemostatic agent and the compositions-treated active hemorrhage of tissue sealant |
| CN114053422A (en) * | 2021-12-28 | 2022-02-18 | 施卫群 | Sodium carboxymethyl starch and its injection |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN85103712B (en) * | 1985-05-13 | 1987-10-21 | 中国科学院上海有机化学研究所 | Blood cell separating agent and its preparation method |
| CN1024498C (en) * | 1987-02-02 | 1994-05-18 | 中国科学院上海有机化学研究所 | Method for preparing pharmaceutical composition containing sodium carboxymethyl starch |
-
2003
- 2003-02-26 CN CNB031155243A patent/CN100336829C/en not_active Expired - Fee Related
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN85103712B (en) * | 1985-05-13 | 1987-10-21 | 中国科学院上海有机化学研究所 | Blood cell separating agent and its preparation method |
| CN1024498C (en) * | 1987-02-02 | 1994-05-18 | 中国科学院上海有机化学研究所 | Method for preparing pharmaceutical composition containing sodium carboxymethyl starch |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2203053B1 (en) | 2008-01-14 | 2017-09-20 | Xin Ji | Modified starch material of biocompatible hemostasis |
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Assignee: Taicang Pharmaceutical Factory Assignor: Dai Lianbao Contract fulfillment period: 2008.12.20 to 2015.12.20 Contract record no.: 2009990000087 Denomination of invention: Carboxymethyl starch sodium preparation, preparing process and use thereof Granted publication date: 20070912 License type: Exclusive license Record date: 20090213 |
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Free format text: EXCLUSIVE LICENSE; TIME LIMIT OF IMPLEMENTING CONTACT: 2008.12.20 TO 2015.12.20; CHANGE OF CONTRACT Name of requester: TAICANG PHARMACEUTICAL FACTORY Effective date: 20090213 |
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