CN1451667A - 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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- CN1451667A CN1451667A CN 03115524 CN03115524A CN1451667A CN 1451667 A CN1451667 A CN 1451667A CN 03115524 CN03115524 CN 03115524 CN 03115524 A CN03115524 A CN 03115524A CN 1451667 A CN1451667 A CN 1451667A
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- starch glycolate
- sodium starch
- sodium
- blood
- pulvis
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Abstract
The preparation of a carboxymethylstarch sodium with 5000-15000 of molecular weight and 0.1-1.0 of carboxymethyl substitution value in the form of powder or injection and its preparing process and use are disclosed. It can be used to treat hemorrhagic shock, the cancer patient in chemicotherapy and radiotherapy, and anemia, and to separate the red cell stored at low temp, stem cells from bone marrow, and white cells from blood.
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 molecule hydroxyl hexyl starch at present.Can only improve blood flow volume.Separating whole blood has only high molecular dextran dialogue cellular segregation rate 56%, and thrombocyte separation rate 53%, input human body can cause that hemodynamic change and oozing of blood change and anaphylaxis.Therefore the value that does not have application clinically.And polymer hydroxyl hexyl starch 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 of the present invention is received preparation system and is contained sodium starch glycolate, also contain physiological saline in case of necessity, perhaps also containing sodium-chlor, glucose and distilled water forms, 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 is dehydrated into pulvis again; Perhaps by carboxymethyl starch, sodium-chlor and glucose pulvis, 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.Furtherly above-mentioned sodium starch glycolate and distilled water weight ratio are respectively 1-50 and 50-99, stir evenly through 90 ℃ of-150 ℃ of 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 with the material of following weight per-cent: sodium starch glycolate 1-15%, sodium-chlor 0.1-1.5%, glucose 0-10% and activated carbon 0.2-2.5%, all the other are distilled water, mix rear decoloring, and bleaching temperature is 80 ℃-120 ℃, time is 15 minutes-200 minutes, filter, preferably, make the aqua sterilisa injection again through the millipore filtration sterilization.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, as just at PO in the faint grade of respiration cycle
2Under the condition of=60mmHg, 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 of liquid drugs injection dosage of the present invention and blood: 1.
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 white corpuscle separation rate 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 the sodium starch glycolatees of 0.1-1.0, sodium-chlor 0,2 kilograms, 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, and 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 the sodium starch glycolatees of 0.1-1.0 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 the sodium starch glycolatees of 0.1-1.0 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 0.2 kilogram in 2 kilograms of sodium starch glycolatees, the sodium-chlor of 0.1-1.0 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.The c group is to the steady statistics P in a para-curve left side＜0.015 of a group, and the two oxygen is separated P
50Value difference is not obvious.The preparation that sodium starch glycolate of the present invention is described 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 contain physiological saline in case of necessity, perhaps also contain sodium-chlor and glucose is formed, the weight ratio of described sodium starch glycolate, physiological saline, sodium chloride and glucose 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 is characterized in that the pulvis of above-mentioned sodium starch glycolate, perhaps adds the injection of physiological saline again, and 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 in that the above-mentioned injection of being made up of following substances per-cent: 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 and distilled water are mixed, through 90 ℃ of-110 ℃ of 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, activated carbon and distilled water are mixed, the decolouring of heating, filter, sterilize into injection, wherein carboxymethyl starch is received, the weight percent of 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---15 ten thousand, 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 to be used for separating with the red corpuscle, the stem cell that separates marrow or the red corpuscle in the whole blood that clean cryopreservation carefully blinking and blood little separating than plate with white.
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 |
Applications Claiming Priority (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 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1451667A true CN1451667A (en) | 2003-10-29 |
| CN100336829C 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 (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2018157772A1 (en) * | 2017-02-28 | 2018-09-07 | 苏州安德佳生物科技有限公司 | Composition for submucosal injection, reagent combination, and applications thereof |
| CN114053422A (en) * | 2021-12-28 | 2022-02-18 | 施卫群 | Sodium carboxymethyl starch and its injection |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104888264B (en) | 2008-01-14 | 2018-01-09 | 北京环球利康科技有限公司 | Biocompatible hemostatic, prevent adhesion, the modified starch material of promoting healing, surgery closing |
Family Cites Families (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 |
| CN1024498C (en) * | 1987-02-02 | 1994-05-18 | 中国科学院上海有机化学研究所 | Manufacture method of medicine to cure repeated intection of respiratory tract and asthma |
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2003
- 2003-02-26 CN CNB031155243A patent/CN100336829C/en not_active Expired - Fee Related
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2018157772A1 (en) * | 2017-02-28 | 2018-09-07 | 苏州安德佳生物科技有限公司 | Composition for submucosal injection, reagent combination, and applications thereof |
| US11213615B2 (en) | 2017-02-28 | 2022-01-04 | EndoClot Plus Co.. Ltd | Composition for submucosal injection, reagent combination, and applications thereof |
| CN114053422A (en) * | 2021-12-28 | 2022-02-18 | 施卫群 | Sodium carboxymethyl starch and its injection |
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| Publication number | Publication date |
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| CN100336829C (en) | 2007-09-12 |
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| EE01 | Entry into force of recordation of patent licensing contract |
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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Granted publication date: 20070912 |