CN107802596A - A kind of hydroxyethyl starch injection liquid composition and preparation method and application - Google Patents
A kind of hydroxyethyl starch injection liquid composition and preparation method and application Download PDFInfo
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- CN107802596A CN107802596A CN201711237224.4A CN201711237224A CN107802596A CN 107802596 A CN107802596 A CN 107802596A CN 201711237224 A CN201711237224 A CN 201711237224A CN 107802596 A CN107802596 A CN 107802596A
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- injection
- water
- liquid composition
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- injection liquid
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/194—Carboxylic acids, e.g. valproic acid having two or more carboxyl groups, e.g. succinic, maleic or phthalic acid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/716—Glucans
- A61K31/718—Starch or degraded starch, e.g. amylose, amylopectin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
Abstract
The present invention relates to a kind of hydroxyethyl starch injection liquid composition and preparation method and application, the hydroxyethyl starch injection liquid composition is using water for injection as solvent, including following components：10~130g/L of HES, 6~12g/L of malate ion, 1.5~5g/L of sodium ion, 0.1~0.3g/L of potassium ion, 0.01~0.07g/L of magnesium ion, 0.03~0.2g/L of calcium ion, 2.0~6.44g/L of chlorion.The present invention is by malic acid and HES compatible use, there is cushioning effect, pH value can be adjusted again, reduces high chlorine metabolic acidosis, can also treat a variety of diseases such as multiple illness hepatopathy, anaemia, hypoimmunity, uremia, hypertension, hepatic failure.
Description
Technical field
The present invention relates to a kind of parenteral solution, and in particular to a kind of to be noted containing the HES of HES and malic acid
Penetrate liquid composition and preparation method and application.
Background technology
Hypovolemic shock refers to a variety of causes, as operation is lost blood and wound, caused by caused circulation volume is lost
Effective circulating blood volume is reduced with cardiac output, perfused tissue deficiency, the disorderly and impaired pathophysiological process of cell metabolism.
Early diagnosis, early stage carry out liquid resuscitation, and hypovolemic shock tends to obtain preferable resuscitation effect.To patient elder generation of losing blood
Giving colloidal solution or crystalloid fluid (i.e. liquid undergoing treatment) can transfuse blood or avoid to transfuse blood less.Liquid resuscitation is often with blood plasma, albumin, crystalline substance
Body fluid and Colloids.Compared with blood plasma, albumin and crystalloid fluid, Artificial colloid has expense as plasma volume expander
It is low, the advantages of long action time, it can be effectively prevented from because communicable disease caused by blood product use occurs.
When HES is formulated as medicinal liquid injection, physiological saline is typically dissolved in, but uses physiological saline as people
The tendency of high chlorine metabolic acidosis during the solvent of work colloid be present, because in human plasma, sodium (normal value 135~
145mmol/l) or chlorine (95~105mmol/l of normal value) concentration significantly lower than the inner sodium of physiological saline (0.9%), chlorinity
(154mmol/l).It is generally acknowledged that high chlorine metabolic acidosis should be avoided in clinic.
HES also has what is be used together with Lactated Ringer'S Solution, sodium lactate ringer's injection conduct regulation body fluid,
Electrolyte and acid-base balance medicine, for metabolic acidosis or there is the dehydration case of metabolic acidosis, lactate is D-ALPHA-Hydroxypropionic acid
The raceme of salt and Pfansteihl salt mixed in equal amounts, and D-lactate has potential cause apoptosis effect.In addition, largely it is transfused in the short time
Lactated Ringer'S Solution can cause high galactaemia, and it is a power consumption process that exogenous input Pfansteihl salt is metabolized in vivo, generation
HCO3 -Neutralize H+Into CO2Existence time hysteresis quality when playing cushioning effect with water, this is unfavorable to hepatotomy and orthotopic liver transplantation.
HES also has what is be used together with bicarbonate ion electrolyte solution, and bicarbonate radical is main cell
Outer buffer composition, its buffer capacity can be adjusted pH value of blood to normal slightly biased alkali, therefore bicarbonate is used to correct in acid
Poison.But because bicarbonate ion easily decomposes in autoclaving process, therefore, pharmaceutical composition is in carbon-dioxide protecting
Lower carry out high-temperature sterilization, cost is higher, and easily introduces other impurities, the unfavorable security used by carbon dioxide.
In order to avoid physiological saline, Lactated Ringer'S Solution use process adverse reaction, generate Acetated Ringer's sodium with
The kind that HES is used in mixed way.But Acetated Ringer's sodium still suffers from segmental defect：Acetated Ringer's sodium venoclysis meeting
Disturb invasive aspergillosis infection following enzyme linked immune assay testing result.
The content of the invention
It is an object of the invention to provide a kind of HES comprising HES and containing malate ion
Injecta composition；The hydroxyethyl starch injection liquid composition, using water for injection as solvent, including following components：
Electrolyte solution containing malate ion is substituted into physiological saline, compound electrolyte solution, lactated Ringer
Liquid and Acetated Ringer's sodium, are used in mixed way with HES, can not only avoid high chlorine metabolic acidosis, high lactic acid disease etc. its
Its adverse reaction, and very good expanding blood volume can be played a part of simultaneously.
Present invention further propose that, described hydroxyethyl starch injection liquid composition, it is characterised in that with water for injection
For solvent, including following components：
Present invention further propose that, the HES be selected from HES 450/0.7, Hetastarch 200/
0.5 or HES 130/0.4；
Wherein, the mean molecule quantity of HES 450/0.7 is 450000 dalton, molar substitution 0.5；Hydroxyl second
The mean molecule quantity of base starch 200/0.5 is 200000 dalton, molar substitution 0.5；HES 130/0.4 is put down
Average molecular weight is 130000, molar substitution 0.4
It is preferred that use HES 130/0.4 (i.e. HES 130/0.4).HES 130/0.4 have can stablize 4~8h's
Cyclical effect curative effect, optimize the effect of hemorheology.
The one kind of the malic acid of the malate ion in D-malic acid, L MALIC ACID or DL-malic acid is provided
It is or a variety of.
L MALIC ACID can be used for treating a variety of diseases such as hepatopathy, anaemia, hypoimmunity, uremia, hypertension, hepatic failure
Disease, its sodium salt are the active drugs for treating dyshepatia particularly vascular hypertension.L MALIC ACID potassium is good potassium supplement
Medicine, it can keep body water to balance, treatment oedema, hypertension and fat generation disease etc..It, which is acted on, is significantly better than ethoxy shallow lake
The mixed solution of powder and physiological saline, compound electrolyte solution, Lactated Ringer'S Solution and Acetated Ringer's sodium composition.Instead of carbonic acid
The electrolyte solution of hydrogen radical ion, reduce production cost.
In addition, malate ion also has cushioning effect, make the stability of its hydroxyethyl starch injection liquid composition more
It is good.
Present invention further propose that, described hydroxyethyl starch injection liquid composition also includes 0.2~0.3 part of citron
Acid ion, preferably 0.229~0.280 part.
Present invention further propose that, it is suitable human injection, the pH value of the hydroxyethyl starch injection liquid composition is
5.0~7.0, preferably 5.5~6.5, more preferably 6.0.
The pH value of the blood plasma of normal person is about 7.35~7.45, to approach the pH value of normal plasma, and avoids introducing hydrogen
OH in sodium oxide molybdena (pH adjusting agent)-, so the pH value of parenteral solution of the present invention is controlled in neutrality.
Using above-mentioned malic acid or apple acid metal salt, the pH value range of electrolyte solution of the present invention falls into pH value
For 5.0~7.0 sections；If there are small deviations, it is adjusted using means commonly used in the art, it is preferred to use hydrochloric acid.
Present invention further propose that, the hydroxyethyl starch injection liquid composition is packaged into single chamber, two Room or multicell.
Include multicomponent being placed in same packaging unit simultaneously, each component can also be separated to packaging, such as wrapped respectively
Loaded in different bags or being packaged in dual chamber or multi-chamber-bag, needed simultaneously according to patient or selectivity uses.
As the present invention preferred scheme, the hydroxyethyl starch injection liquid composition, using water for injection as solvent, including
Following components：
The present invention's further provides for preferred scheme, the hydroxyethyl starch injection liquid composition, using water for injection to be molten
Agent, including following components：
Present invention further propose that preferred scheme, the hydroxyethyl starch injection liquid composition, using water for injection to be molten
Agent, including following components：
It is further proposed that another preferred scheme, the hydroxyethyl starch injection liquid composition, using water for injection as solvent,
Including following components：
Room one:
Malic acid 8g/L
Room two
It is further proposed that another preferred scheme, the hydroxyethyl starch injection liquid composition, using water for injection as solvent,
Including following components：
Room one:
Malic acid 8g/L
Room two
Room three
Calcium chloride 0.215g/L
The second object of the present invention is the preparation method for providing above-mentioned hydroxyethyl starch injection liquid composition, takes injection
Water, by each component by matching, it is completely dissolved in water for injection, fills into water for injection, pH value is adjusted using conventional meanses, it is filling
Sterilizing.
The present invention further provides the preparation method of another hydroxyethyl starch injection liquid composition, including following step
Suddenly：
1) malic acid for providing malate ion is dissolved in water for injection, fills into water for injection adjustment pH value, fill
Fill as the first Room, sterilizing；
2) other components are dissolved in water for injection by proportioning, fill into water for injection adjustment pH value, filling is second Room,
Sterilizing.
After filling, individually sterilizing or unification sterilizes multicell parenteral solution.
The third object of the present invention is described hydroxyethyl starch injection liquid composition on expanding blood volume medicine
Using；
Preferably, the application on dyshepatia, hypertension or hypertension complication patient's expanding blood volume medicine.
Because Ca2+Other medicines with being commonly used in anesthesia and monitoring have consistency problem, therefore, to ensure anesthesia, severe
The normal use of common medicine during monitoring, the flexibility of Clinical practice can be easy to individually in the 3rd filling calcium salt in Room.
The present invention at least has the advantages that：
1) as Hypovolemia caused by acute bleeding, wound, septicemia, burn or intestinal obstruction, severe diarrhea etc. and its
Shock is clinical common Severe acute disease, and it is primary remedy measures to control fluid loss and early recovery blood volume, in
Molecular weight, low degree of substitution HES 130/0.4, ensure that the unification of validity and security.
2) by malic acid and HES compatible use, that is, there is cushioning effect, pH value can be adjusted again, reduce high chloro
The acid poisoning of thanking property, can also be to more with multiple illness hepatopathy, anaemia, hypoimmunity, uremia, hypertension, hepatic failure etc.
The patient of kind disease plays therapeutic action；
3) the filling design of multicell, it is the compliance of clinical indication and treatment, there is provided the facility of flexible Application.
Brief description of the drawings
Fig. 1 is that the hydroxyethyl starch injection liquid composition described in embodiment 1 carries out mouse injection observation endogenous and external source
The situation of change figure of property coagulation function and platelet function；
Fig. 2 is that the hydroxyethyl starch injection liquid composition described in comparative example 1 carries out mouse injection observation endogenous and external source
The situation of change figure of property coagulation function and platelet function；
Embodiment
Following examples are used to illustrate the present invention, but are not limited to the scope of the present invention.In following examples,
Following examples agents useful for same is commercially available；
Wherein, HES is purchased from Chifeng Addisun Pharmaceutical Co., Ltd.
Embodiment 1
The present embodiment is a kind of hydroxyethyl starch injection liquid composition, by weight, is made up of following component：
PH value is 6.0
The preparation method of the electrolyte injection, it is specially：Water for injection is taken, by each component by proportioning, is dissolved in note
Penetrate with fully dissolving in water, is stirred, fill into water for injection, adjust pH value, sterilization filling.
Embodiment 2
The present embodiment is a kind of hydroxyethyl starch injection liquid composition, by weight, is made up of following component：
PH value is 5.5
The preparation method of the electrolyte injection, it is specially：Water for injection is taken, by each component by proportioning, is dissolved in note
Penetrate with fully dissolving in water, is stirred, fill into water for injection, adjust pH value, sterilization filling.
Embodiment 3
The present embodiment is a kind of hydroxyethyl starch injection liquid composition, by weight, is made up of following component：
PH value is 6.5
The preparation method of the electrolyte injection, it is specially：Water for injection is taken, by each component by proportioning, is dissolved in note
Penetrate with fully dissolving in water, is stirred, fill into water for injection, adjust pH value, sterilization filling.
Embodiment 4
The present embodiment is a kind of hydroxyethyl starch injection liquid composition, by weight, is made up of following component：
PH value is 6.0
The preparation method of the electrolyte injection, it is specially：Water for injection is taken, by each component by proportioning, is dissolved in note
Penetrate with fully dissolving in water, is stirred, fill into water for injection, adjust pH value, sterilization filling.
Embodiment 5
The present embodiment is a kind of hydroxyethyl starch injection liquid composition, by weight, is made up of following component：
Room one:
Malic acid 10g
Water for injection adds to 1000mL
Room two
PH value is 6.0
The preparation method of the electrolyte injection, comprises the following steps：
1) malic acid is dissolved in water for injection, fills into the water for injection of surplus, filling is the first Room；
2) other components are dissolved in water for injection by proportioning, fill into the water for injection of surplus, filling is second Room,
Sterilize two Room simultaneously, adds outer bag to pack.
Embodiment 6
The present embodiment is a kind of hydroxyethyl starch injection liquid composition, by weight, is made up of following component：
Room one:
Malic acid 8g
Water for injection adds to 1000mL
Room two
PH value is 6.0.
Room three
Calcium chloride 0.215g
Water for injection adds to 1000mL
PH value is 6.0
The preparation method of the electrolyte injection, comprises the following steps：
1) malic acid is dissolved in water for injection, fills into the water for injection of surplus, filling is the first Room；
2) calcium chloride is dissolved in water for injection by proportioning, fills into the water for injection of surplus, filling is the 3rd Room.
3) other components are dissolved in water for injection by proportioning, fill into the water for injection of surplus, filling is second Room,
Sterilize three rooms simultaneously, adds outer bag to pack.
Comparative example 1
This comparative example is a kind of hydroxyethyl starch injection liquid composition, and the difference with embodiment 1 is formed sediment using ethoxy
Powder 200/0.5 replaces HES 130/0.4.
Experimental example 1
The injection contrast of hydroxyethyl starch injection liquid composition described in embodiment 1 and comparative example
1st, it is the hydroxyethyl starch injection liquid composition progress mouse injection observation described in embodiment 1 and comparative example 1 is endogenous
Property and extrinsic coagulation function and platelet function change, as depicted in figs. 1 and 2, wherein 1 for infusion before, 2 for infusion after
30min, 3 be 4h after infusion.
It is transfused hydroxyethyl starch injection liquid group described in hydroxyethyl starch injection liquid composition described in embodiment 1 and comparative example 1
Compound can cause the factor of blood plasma VIII and VWF to be remarkably decreased, but hydroxyethyl starch injection liquid composition is brighter described in comparative example 1
It is aobvious.The internal extrinsic coagulation of hydroxyethyl starch injection liquid composition described in embodiment 1 and platelet function are without influence, and comparative example
The 1 hydroxyethyl starch injection liquid composition then has obvious infringement.
2nd, after hydroxyethyl starch injection liquid composition infusion 1h described in embodiment 1, blood plasma HES relative molecular mass exists
(64~74) × 103In the range of, it is unchanged in 24h；After hydroxyethyl starch injection liquid composition injection described in comparative example 1, need
8~24h is wanted to reach corresponding blood plasma relative molecular mass scope.
3rd, after the hydroxyethyl starch injection liquid composition infusion 24h described in comparative example 1, its HES200/0.5 is in blood plasma
Concentration is 1~3mg/ml；After hydroxyethyl starch injection liquid composition infusion 24h described in embodiment 1, its HES130/0.4 is in blood plasma
In concentration be less than 0.5mg/mL；Illustrate that hydroxyethyl starch injection liquid composition can be removed rapidly described in embodiment 1.It is transfused 48h
Afterwards, HES130/0.4 maximum relative molecular mass is 47 × 10 in urine3, the starch than other intermediate relative molecular quality is low.
4th, above-mentioned injection repeated application detection, its HES 130/0.4 whole body, liver and pancreas accumulation than HES 200/
0.5 is low.
As can be seen here, the hydroxyethyl starch injection liquid composition described in embodiment 1 forms sediment with the ethoxy described in documents 1
Powder injecta composition is compared, and has a more excellent physicochemical property, good dilatation (degree and duration), preferably
Improve tissue oxygen to supply, can escalated dose (50mL/kg) can be long-term use of, the influence to coagulation function is minimum, to renal function without bright
Development rings, and no blood plasma accumulation, tissue accumulation significantly reduces, available for children.
Experimental example 2
Injection contrast is carried out to above-described embodiment 1~6 and comparative example 1, blood plasma HES relative molecular mass is in (64~74)
×103In the range of change contrast such as following table：
Table 1
| After injecting 1h | After injecting 4h | After injecting 24h | |
| Embodiment 1 | It is unchanged | It is unchanged | It is unchanged |
| Embodiment 2 | It is low | It is low | It is low |
| Embodiment 3 | Reach standard | It is above standard | It is above standard |
| Embodiment 4 | It is unchanged | It is unchanged | It is unchanged |
| Embodiment 5 | It is unchanged | It is unchanged | It is unchanged |
| Embodiment 6 | It is unchanged | It is unchanged | It is unchanged |
| Comparative example 1 | It is low | It is low | Reach standard |
Note：It is unchanged to refer to be always maintained at corresponding blood plasma relative molecular mass scope.
Although above the present invention is made to retouch in detail with general explanation, embodiment and experiment
State, but on the basis of the present invention, it can be made some modifications or improvements, this is apparent to those skilled in the art
's.Therefore, these modifications or improvements without departing from theon the basis of the spirit of the present invention, are belonged to claimed
Scope.
Claims (10)
- A kind of 1. hydroxyethyl starch injection liquid composition, it is characterised in that using water for injection as solvent, including following components：
- 2. hydroxyethyl starch injection liquid composition according to claim 1, it is characterised in that using water for injection as solvent, Including following components：
- 3. hydroxyethyl starch injection liquid composition according to claim 1, it is characterised in that the HES is selected from HES 450/0.7, Hetastarch 200/0.5 or HES 130/0.4；And/or, there is provided the malic acid of the malate ion in D-malic acid, L MALIC ACID or DL-malic acid one Kind is a variety of.
- 4. hydroxyethyl starch injection liquid composition according to claim 1, it is characterised in that also including 0.2~0.3g/L Citric acid radical ion, preferably 0.229~0.280g/L.
- 5. hydroxyethyl starch injection liquid composition according to claim 1, it is characterised in that the HES injection The pH value of liquid composition is 5.0~7.0, preferably 5.5~6.5, more preferably 6.0.
- 6. hydroxyethyl starch injection liquid composition according to claim 1, it is characterised in that the HES injection Liquid composition is packaged into single chamber, two Room or multicell.
- 7. hydroxyethyl starch injection liquid composition according to claim 1, it is characterised in that using water for injection as solvent, Including following components：Preferably, the hydroxyethyl starch injection liquid composition, using water for injection as solvent, including following components：It is further preferred that the hydroxyethyl starch injection liquid composition, using water for injection as solvent, including following components：
- 8. the preparation method of any hydroxyethyl starch injection liquid composition of claim 1~7, it is characterised in that take injection With water, by each component by proportioning, it is completely dissolved in water for injection, fills into water for injection adjustment pH value, filling sterilizing.
- 9. the preparation method of any hydroxyethyl starch injection liquid composition of claim 1~7, it is characterised in that including with Lower step：1) malic acid for providing malate ion is dissolved in water for injection, fills into water for injection adjustment pH value, it is filling to be First Room；2) other components are dissolved in water for injection by proportioning, fill into water for injection adjustment pH value, filling is second Room, simultaneously Sterilize two rooms, adds outer bag to pack；Preferably, the preparation method of the electrolyte injection, it is characterised in that comprise the following steps：1) malic acid is dissolved in water for injection, fills into the water for injection of surplus, filling is the first Room；2) calcium chloride is dissolved in water for injection by proportioning, fills into the water for injection of surplus, filling is the 3rd Room；3) other components are dissolved in water for injection by proportioning, fill into the water for injection of surplus, filling is second Room, simultaneously Sterilize three rooms, adds outer bag to pack.
- 10. application of any described hydroxyethyl starch injection liquid composition of claim 1~7 on expanding blood volume medicine；Preferably, the application on dyshepatia, hypertension or hypertension complication patient's expanding blood volume medicine.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201711237224.4A CN107802596A (en) | 2017-11-30 | 2017-11-30 | A kind of hydroxyethyl starch injection liquid composition and preparation method and application |
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| CN201711237224.4A CN107802596A (en) | 2017-11-30 | 2017-11-30 | A kind of hydroxyethyl starch injection liquid composition and preparation method and application |
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103175802A (en) * | 2011-12-20 | 2013-06-26 | 四川科伦药物研究有限公司 | Method for determining content of magnesium element in hydroxyethyl starch injection preparation |
| CN103989704A (en) * | 2013-02-19 | 2014-08-20 | B.布劳恩梅尔松根股份公司 | Electrolyte water solution for transfusion |
| CN104306396A (en) * | 2013-10-21 | 2015-01-28 | 湖北博瑞佳医药科技有限公司 | Hydroxyethyl starch 130 sodium lactate ringer injection and preparation method thereof |
| CN105342994A (en) * | 2010-11-29 | 2016-02-24 | 株式会社大塚制药工场 | Infusion preparation |
-
2017
- 2017-11-30 CN CN201711237224.4A patent/CN107802596A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105342994A (en) * | 2010-11-29 | 2016-02-24 | 株式会社大塚制药工场 | Infusion preparation |
| CN103175802A (en) * | 2011-12-20 | 2013-06-26 | 四川科伦药物研究有限公司 | Method for determining content of magnesium element in hydroxyethyl starch injection preparation |
| CN103989704A (en) * | 2013-02-19 | 2014-08-20 | B.布劳恩梅尔松根股份公司 | Electrolyte water solution for transfusion |
| CN104306396A (en) * | 2013-10-21 | 2015-01-28 | 湖北博瑞佳医药科技有限公司 | Hydroxyethyl starch 130 sodium lactate ringer injection and preparation method thereof |
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