CN101081229B - Plasma subtitute injection using hydroxyethyl group amylum as blood plasma dilatancy agent - Google Patents
Plasma subtitute injection using hydroxyethyl group amylum as blood plasma dilatancy agent Download PDFInfo
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- CN101081229B CN101081229B CN2006100210486A CN200610021048A CN101081229B CN 101081229 B CN101081229 B CN 101081229B CN 2006100210486 A CN2006100210486 A CN 2006100210486A CN 200610021048 A CN200610021048 A CN 200610021048A CN 101081229 B CN101081229 B CN 101081229B
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- China
- Prior art keywords
- injection
- plasma
- hetastarch
- chloride
- sodium
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- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- 239000007924 injection Substances 0.000 title claims abstract description 36
- 238000002347 injection Methods 0.000 title claims abstract description 36
- -1 hydroxyethyl group Chemical group 0.000 title description 3
- 210000002381 plasma Anatomy 0.000 title 2
- 235000019890 Amylum Nutrition 0.000 title 1
- 229920002472 Starch Polymers 0.000 title 1
- 239000003795 chemical substances by application Substances 0.000 title 1
- 229920001612 Hydroxyethyl starch Polymers 0.000 claims abstract description 46
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims abstract description 28
- 239000003058 plasma substitute Substances 0.000 claims abstract description 28
- WCUXLLCKKVVCTQ-UHFFFAOYSA-M Potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 claims abstract description 26
- CYDQOEWLBCCFJZ-UHFFFAOYSA-N 4-(4-fluorophenyl)oxane-4-carboxylic acid Chemical compound C=1C=C(F)C=CC=1C1(C(=O)O)CCOCC1 CYDQOEWLBCCFJZ-UHFFFAOYSA-N 0.000 claims abstract description 14
- 239000011780 sodium chloride Substances 0.000 claims abstract description 14
- 239000001540 sodium lactate Substances 0.000 claims abstract description 14
- 235000011088 sodium lactate Nutrition 0.000 claims abstract description 14
- 229940005581 sodium lactate Drugs 0.000 claims abstract description 14
- 239000001103 potassium chloride Substances 0.000 claims abstract description 13
- 235000011164 potassium chloride Nutrition 0.000 claims abstract description 13
- 235000002639 sodium chloride Nutrition 0.000 claims abstract description 13
- UXVMQQNJUSDDNG-UHFFFAOYSA-L Calcium chloride Chemical compound [Cl-].[Cl-].[Ca+2] UXVMQQNJUSDDNG-UHFFFAOYSA-L 0.000 claims abstract description 12
- 239000001110 calcium chloride Substances 0.000 claims abstract description 12
- 229910001628 calcium chloride Inorganic materials 0.000 claims abstract description 12
- 235000011148 calcium chloride Nutrition 0.000 claims abstract description 11
- JVTAAEKCZFNVCJ-UHFFFAOYSA-M Lactate Chemical compound CC(O)C([O-])=O JVTAAEKCZFNVCJ-UHFFFAOYSA-M 0.000 claims abstract description 3
- 239000001527 calcium lactate Substances 0.000 claims abstract description 3
- 235000011086 calcium lactate Nutrition 0.000 claims abstract description 3
- 229960002401 calcium lactate Drugs 0.000 claims abstract description 3
- 238000006467 substitution reaction Methods 0.000 claims abstract 2
- 229940027278 hetastarch Drugs 0.000 claims description 37
- 239000000203 mixture Substances 0.000 claims description 8
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 claims description 7
- 229960001031 glucose Drugs 0.000 claims description 7
- DHRRIBDTHFBPNG-UHFFFAOYSA-L magnesium dichloride hexahydrate Chemical compound O.O.O.O.O.O.[Mg+2].[Cl-].[Cl-] DHRRIBDTHFBPNG-UHFFFAOYSA-L 0.000 claims description 7
- 230000036571 hydration Effects 0.000 claims description 4
- 238000006703 hydration reaction Methods 0.000 claims description 4
- 239000002994 raw material Substances 0.000 claims description 2
- 239000008280 blood Substances 0.000 abstract description 8
- 210000004369 blood Anatomy 0.000 abstract description 8
- 229940050526 hydroxyethylstarch Drugs 0.000 abstract description 8
- 230000000694 effects Effects 0.000 abstract description 7
- 239000000306 component Substances 0.000 abstract 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 9
- 239000003792 electrolyte Substances 0.000 description 8
- 229960002713 calcium chloride Drugs 0.000 description 6
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 description 5
- 239000000243 solution Substances 0.000 description 5
- 238000003756 stirring Methods 0.000 description 5
- 239000008215 water for injection Substances 0.000 description 5
- 208000010444 Acidosis Diseases 0.000 description 4
- 206010027417 Metabolic acidosis Diseases 0.000 description 4
- 210000001124 body fluid Anatomy 0.000 description 4
- 239000010839 body fluid Substances 0.000 description 4
- 239000000706 filtrate Substances 0.000 description 4
- 239000004615 ingredient Substances 0.000 description 4
- 238000002360 preparation method Methods 0.000 description 4
- 108010010803 Gelatin Proteins 0.000 description 3
- 239000008156 Ringer's lactate solution Substances 0.000 description 3
- BMLSTPRTEKLIPM-UHFFFAOYSA-I calcium;potassium;disodium;hydrogen carbonate;dichloride;dihydroxide;hydrate Chemical compound O.[OH-].[OH-].[Na+].[Na+].[Cl-].[Cl-].[K+].[Ca+2].OC([O-])=O BMLSTPRTEKLIPM-UHFFFAOYSA-I 0.000 description 3
- 229910052799 carbon Inorganic materials 0.000 description 3
- 229920000159 gelatin Polymers 0.000 description 3
- 239000008273 gelatin Substances 0.000 description 3
- 235000019322 gelatine Nutrition 0.000 description 3
- 235000011852 gelatine desserts Nutrition 0.000 description 3
- 229940050906 magnesium chloride hexahydrate Drugs 0.000 description 3
- 239000008354 sodium chloride injection Substances 0.000 description 3
- 238000005303 weighing Methods 0.000 description 3
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 2
- 230000015271 coagulation Effects 0.000 description 2
- 238000005345 coagulation Methods 0.000 description 2
- 230000018044 dehydration Effects 0.000 description 2
- 238000006297 dehydration reaction Methods 0.000 description 2
- 239000008103 glucose Substances 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- 230000002085 persistent effect Effects 0.000 description 2
- 229960002816 potassium chloride Drugs 0.000 description 2
- 239000000047 product Substances 0.000 description 2
- 230000001105 regulatory effect Effects 0.000 description 2
- 229960002668 sodium chloride Drugs 0.000 description 2
- 230000001954 sterilising effect Effects 0.000 description 2
- 206010053567 Coagulopathies Diseases 0.000 description 1
- 229920002307 Dextran Polymers 0.000 description 1
- 206010021137 Hypovolaemia Diseases 0.000 description 1
- 238000009825 accumulation Methods 0.000 description 1
- 230000002052 anaphylactic effect Effects 0.000 description 1
- LLSDKQJKOVVTOJ-UHFFFAOYSA-L calcium chloride dihydrate Chemical compound O.O.[Cl-].[Cl-].[Ca+2] LLSDKQJKOVVTOJ-UHFFFAOYSA-L 0.000 description 1
- 229940052299 calcium chloride dihydrate Drugs 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 230000035602 clotting Effects 0.000 description 1
- 239000000084 colloidal system Substances 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 125000001301 ethoxy group Chemical group [H]C([H])([H])C([H])([H])O* 0.000 description 1
- 238000001914 filtration Methods 0.000 description 1
- 229940053703 hextend Drugs 0.000 description 1
- 230000001771 impaired effect Effects 0.000 description 1
- 238000001802 infusion Methods 0.000 description 1
- 238000007689 inspection Methods 0.000 description 1
- 239000011777 magnesium Substances 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 238000005374 membrane filtration Methods 0.000 description 1
- 230000008520 organization Effects 0.000 description 1
- 238000012856 packing Methods 0.000 description 1
- 239000011265 semifinished product Substances 0.000 description 1
- 238000004659 sterilization and disinfection Methods 0.000 description 1
- 230000009469 supplementation Effects 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 229940075601 voluven Drugs 0.000 description 1
Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The plasma substitute injection with hydroxyethyl starch as plasma expander has hydroxyethyl starch in the weight-average molecular weight of 130 KD and molar substitution degree of 0.4 as the main component, sodium chloride, potassium chloride, calcium chloride and lactate components. Each 100 ml of the injection contains hydroxyethyl starch 6 g, sodium chloride 600-672 mg, potassium chloride 22-30 mg, calcium chloride dehydrate 20-37 mg, and sodium lactate 310-317 mg. The injection is superior to available plasma substitute injections in the plasma expanding effect, the influence on blood system, etc.
Description
Technical field
The present invention relates to a kind of with the plasma substitute injection of hetastarch as plasma expander.
Background technology
Plasma expander commonly used at present mainly contains dextran, polyvidon, hetastarch, gelatin and polyglucose etc.
Gelatin class I liquid I molecular weight is little, and is less to the influence of coagulation function, but the dilatation time is shorter, and it is higher that anaphylactoid risk takes place simultaneously.Dextran class I liquid I molecular weight is 40,000-70, and 000 dalton, the dilatation time prolongs to some extent than gelatin, but to the coagulation function influence significantly.Untoward reaction happens occasionally.In present artificial plasma expander, the dilatation effect of hetastarch is the most desirable, becomes the most widely used a kind of plasma expander gradually.
In numerous hetastarch products, can be divided into M by molecular weight
w＜100, the low-molecular-weight hetastarch of 000D, M
wBe 100,000D～300, the middle molecular weight hydroxyethyl starch of 000D and, M
w＞300,3 kinds of 000D high molecular weight hydroxyethyl starch; Can be divided into low (Ms 03.～0.6) and the high hetastarch that replaces (Ms 〉=0.7) of replacing by the replacement degree.Because the dilatation intensity of low-molecular-weight hetastarch is little, and the impaired and body accumulation of clotting mechanism may take place because of overstand in the body in the high hetastarch that replaces level.Therefore now middle molecular weight hydroxyethyl starch more and more comes into one's own.The use report of the hetastarch sodium chloride injection of for example existing commodity " HES " by name, the molecular weight of wherein used hetastarch is 200,000D, replacement level are 0.5 (200/0.5).
On the other hand, except that the hetastarch that contains as plasma expander, also containing other suitable compositions is needs in the plasma substitute goods.Existing at present as the product Voluven of German Fresenius card than company
, use be hetastarch 130/0.4 sodium chloride injection.In addition, the 6% hetastarch sodium lactate ringer's injection of commodity Hextend by name also has the report of use.Though sodium lactate ringer's injection is as regulating body fluid, electrolyte and acid-base balance medicine, be used for metabolic acidosis or the dehydration case of metabolic acidosis is arranged, and demand is bigger, be widely used in clinical, but wherein used is 450, high molecular weight hydroxyethyl starch about 000D, and the replacement level is 0.75.Practice shows, used hetastarch kind difference, and other auxiliary elements that contained and/or content difference all are influential to the effect of using.
Summary of the invention
In view of the foregoing, the present invention will provide a kind of new composition form with the plasma substitute injection of hetastarch as plasma expander, make it more can meet the interior environment of blood of human body, reliable and stable capacity effect and the persistent period not only can be provided, and can demonstrate remarkable more safety.
The present invention is with the plasma substitute injection of hetastarch as plasma expander, be to be 130 with weight average molecular weight, it is that 0.4 (130/0.4) hetastarch is a primary raw material that 000 dalton, mole replace level, and at least also contains sodium chloride, potassium chloride, calcium chloride and lactate composition.Contained each components in proportions is in wherein per 100 milliliters of injection:
Hetastarch 6g, sodium chloride 600～672mg, potassium chloride 22～30mg,
Two hydration calcium chloride, 20～37mg, sodium lactate 310～317mg.
Use needs according to clinical difference, on the basis of above-mentioned composition, can also contain Magnesium dichloride hexahydrate 9mg and/or glucose monohydrate 99mg again in per 100 milliliters of injection.
The hetastarch 130/0.4 that uses in the plasma substitute injection of the present invention, belong to a kind of middle molecular weight hydroxyethyl starch, its molecular weight is 130000 left and right sides dalton, and molecular distribution is more concentrated, further reduce than the existing molecular weight of 200/0.5 hetastarch of report that uses, the replacement level of ethoxy is reduced to 0.4 from 0.5, and can be with the replacement mode from C
2With C
5(or C
6) ratio increased to 9: 1 by 5: 1, help obtaining better effect.On this basis, simultaneously again with sodium lactate and the common compound injection of forming of multiple electrolyte ingredient optimum organization, make it can reach the target of " desirable colloid solution ".It not only can provide reliable and stable capacity effect and persistent period, and more meet the interior environment of human blood, influence and the effect of expansion blood appearance to blood system also all are better than plasma substitutes such as hetastarch 130/0.4 sodium chloride injection and hetastarch 200/0.5 sodium lactate ringer's injection, more ideal comprehensive therapeutic effect can be arranged, also convenient clinical use.
The specific embodiment by the following examples is described in further detail foregoing of the present invention again.But this should be interpreted as that the scope of the above-mentioned theme of the present invention only limits to following example.Do not breaking away under the above-mentioned technological thought situation of the present invention, various replacements or change according to ordinary skill knowledge and customary means are made all should comprise within the scope of the invention.
The specific embodiment
Embodiment 1
Injection is formed (by every 100ml injection):
Hetastarch (130/0.4) 6g,
Sodium chloride 672mg,
Potassium chloride 22mg,
Magnesium chloride hexahydrate 9mg,
Calcium chloride (CaCl
22H
2O) 37mg,
Sodium lactate 317mg,
Glucose monohydrate 99mg,
Water for injection is supplemented to capacity.
Preparation method:
A, hetastarch (130/0.4) is added an amount of water for injection stir, be heated to 40～100 ℃ of dissolvings then;
B, respectively sodium chloride, potassium chloride, magnesium chloride hexahydrate, calcium chloride dihydrate, sodium lactate, glucose monohydrate are dissolved in water again, and add in the solution of front, regulator solution pH to 5～7.5;
C, add an amount of activated carbon decolorizing;
D, filtration, membrane filtration, fill;
E, in 100 ℃～115 ℃ sterilizations 15～35 minutes, lamp inspection, packing then.
This routine injection can replenishment of blood content and multiple electrolyte ingredient to regulate body fluid, electrolyte and acid-base balance, be used for metabolic acidosis or dehydration and a large amount of hypovolemic case of metabolic acidosis arranged.
Embodiment 2
Injection is formed (by every 1000ml injection):
Hetastarch (130/0.4) 60g
Sodium lactate 3.10g
Sodium chloride 6.00g
Potassium chloride 0.30g
Calcium chloride (CaCl
22H
2O) 0.20g
Water for injection is supplemented to capacity.
The preparation method of this injection has following steps
Preparation method:
A. calculate and take by weighing various supplementary materials by recipe quantity.Hetastarch (130/0.4) is added an amount of water for injection stir, be heated to 40～100 ℃ of dissolvings then, add active carbon (liquor capacity 0.1%) and stir decolouring 15 minutes, filter, filtrate pumps into dilute preparing tank;
B. the sodium lactate that takes by weighing is added the injection water and make solution into about 10% concentration, heated and stirred adds active carbon (liquor capacity 0.1%), boils the back and stirs 15 minutes, filters, and filtrate pumps into dilute preparing tank;
C. with the sodium chloride, potassium chloride, the calcium chloride that take by weighing, add the injection water and make the concentration of sodium chloride be about 20%, heated and stirred adds active carbon (liquor capacity 0.1%), boils the back and stirs 15 minutes, filters, and filtrate pumps into dilute preparing tank;
D. merge above solution, add the injection water to content, regulate pH to 5～7.5 and measure semi-finished product content qualified after, through microporous filter membrane (≤0.45um) filter, check the qualified back of filtrate clarity, fill in the 500ml infusion vessel, top plug, through 115 ℃, the 30min pressure sterilizing, promptly.
This routine injection can be at need replenishment of blood content and multiple electrolyte ingredient, regulating body fluid, electrolyte and acid-base balance, but does not need to use under the situation of Mg supplementation and glucose.
Embodiment 3
Injection is formed (by every 100ml injection):
Hetastarch (130/0.4) 6g,
Sodium chloride 672mg,
Potassium chloride 22mg,
Magnesium chloride hexahydrate 9mg,
Calcium chloride (CaCl
22H
2O) 37mg,
Sodium lactate 317mg,
Water for injection is supplemented to capacity.
Preparation method is with embodiment 1.
But this routine injection supply and demand replenishment of blood content and multiple electrolyte ingredient to regulate body fluid, electrolyte and acid-base balance, need not replenish under the situation of glucose and use.
Claims (5)
1. with the plasma substitute injection of hetastarch as plasma expander, with weight average molecular weight is that 130,000 dalton, molar substitution are that 0.4 hetastarch is a primary raw material, and at least also contain sodium chloride, potassium chloride, calcium chloride and lactate composition, it is characterized in that the content ratio of said each composition in per 100 milliliters of injection is:
Hetastarch 6g, sodium chloride 672mg, potassium chloride 22mg,
Two hydration calcium chloride 37mg, sodium lactate 317mg.
2. as claimed in claim 1 with the plasma substitute injection of hetastarch as plasma expander, it is characterized in that also containing Magnesium dichloride hexahydrate 7～11mg in per 100 milliliters of injection.
3. as claimed in claim 1 with the plasma substitute injection of hetastarch as plasma expander, it is characterized in that also containing glucose monohydrate 90～110mg in per 100 milliliters of injection.
4. as claimed in claim 1 or 2 with the plasma substitute injection of hetastarch as plasma expander, it is characterized in that the content ratio of said each composition in per 100 milliliters of injection is
Hetastarch 6g, sodium chloride 672mg, potassium chloride 22mg,
Magnesium dichloride hexahydrate 9mg, two hydration calcium chloride 37mg, sodium lactate 317mg.
5. described with the plasma substitute injection of hetastarch as plasma expander as one of claim 1 to 3, it is characterized in that the content ratio of said each composition in per 100 milliliters of injection is
Hetastarch 6g, sodium chloride 672mg, potassium chloride 22mg,
Magnesium dichloride hexahydrate 9mg, two hydration calcium chloride 37mg, sodium lactate 317mg,
Glucose monohydrate 99mg.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2006100210486A CN101081229B (en) | 2006-05-30 | 2006-05-30 | Plasma subtitute injection using hydroxyethyl group amylum as blood plasma dilatancy agent |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2006100210486A CN101081229B (en) | 2006-05-30 | 2006-05-30 | Plasma subtitute injection using hydroxyethyl group amylum as blood plasma dilatancy agent |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN101081229A CN101081229A (en) | 2007-12-05 |
| CN101081229B true CN101081229B (en) | 2011-01-26 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2006100210486A Active CN101081229B (en) | 2006-05-30 | 2006-05-30 | Plasma subtitute injection using hydroxyethyl group amylum as blood plasma dilatancy agent |
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Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101450075B (en) * | 2007-11-30 | 2012-01-18 | 成都正康药业有限公司 | Hydroxyethyl starch 130/0.4 sodium chloride injection and preparation method and use thereof |
| CN102397290B (en) * | 2011-06-27 | 2013-06-05 | 辽宁海神联盛制药有限公司 | Hydroxyethyl starch injection and preparation method thereof |
| CN106706918A (en) * | 2016-11-21 | 2017-05-24 | 江苏力博医药生物技术股份有限公司 | Method for preparing ABO external quality assessment quality control material of human plasma (serum) substitute substrate |
| CN107617236A (en) * | 2017-09-28 | 2018-01-23 | 安徽信灵检验医学科技有限公司 | A kind of platelet rich liquid |
| CN114053422A (en) * | 2021-12-28 | 2022-02-18 | 施卫群 | Sodium carboxymethyl starch and its injection |
-
2006
- 2006-05-30 CN CN2006100210486A patent/CN101081229B/en active Active
Non-Patent Citations (6)
| Title |
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| 杨凤兰，张逸晨.羟乙基淀粉溶液用于出血性休克的疗效观察.浙江创伤外科10 3.2005,10(3),223-224. |
| 杨凤兰,张逸晨.羟乙基淀粉溶液用于出血性休克的疗效观察.浙江创伤外科10 3.2005,10(3),223-224. * |
| 谭冠先等.羟乙基淀粉－平衡液应用于失血性休克的动物实验.临床麻醉学杂志1 1.1985,1(1),30-32. |
| 谭冠先等.羟乙基淀粉-平衡液应用于失血性休克的动物实验.临床麻醉学杂志1 1.1985,1(1),30-32. * |
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