CN109265338A - The production method of medical sodium lactate solution - Google Patents
The production method of medical sodium lactate solution Download PDFInfo
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- CN109265338A CN109265338A CN201811173911.9A CN201811173911A CN109265338A CN 109265338 A CN109265338 A CN 109265338A CN 201811173911 A CN201811173911 A CN 201811173911A CN 109265338 A CN109265338 A CN 109265338A
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- solution
- lactic acid
- sodium lactate
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
- C07C51/00—Preparation of carboxylic acids or their salts, halides or anhydrides
- C07C51/41—Preparation of salts of carboxylic acids
- C07C51/412—Preparation of salts of carboxylic acids by conversion of the acids, their salts, esters or anhydrides with the same carboxylic acid part
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
- C07C51/00—Preparation of carboxylic acids or their salts, halides or anhydrides
- C07C51/42—Separation; Purification; Stabilisation; Use of additives
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
- C07C51/00—Preparation of carboxylic acids or their salts, halides or anhydrides
- C07C51/42—Separation; Purification; Stabilisation; Use of additives
- C07C51/47—Separation; Purification; Stabilisation; Use of additives by solid-liquid treatment; by chemisorption
Abstract
The invention discloses a kind of production methods of medical sodium lactate solution, comprising the following steps: 1) using food grade lactic acid as raw material, concentrated distillation obtains the lactic acid of resistance to thermal level；2) water and sodium hydroxide solution is added to react the lactic acid of resistance to thermal level, until the pH of reaction solution is 7.5-8.5；3) activated carbon adsorption decolorization is added, is then allowed to stand processing；The pH value for adjusting mixture again is 7.8-8.2；Sodium lactate mass fraction is obtained in the solution of 60%-75% after finally carrying out coarse filtration, refined filtration and concentration.The present invention reacts sodium lactate solution obtained with high purity sodium hydroxide solution using the lactic acid of resistance to thermal level of high-purity, and impurity content is low, and product purity is high, can be used as bulk pharmaceutical chemicals sodium lactate solution production sodium lactate injection, peritoneal dialysis solution etc..
Description
Technical field
A kind of medical material technical field of the present invention, and in particular to production method of medical sodium lactate solution.
Background technique
Sodium lactate, chemical formula CH3CHOHCOONa, molecular weight 112.06, colourless or almost colourless transparent viscous liquid,
Odorlessness can be mixed with water, ethyl alcohol, glycerol.Food grade lactic acid sodium is widely used in the fresh-keeping of food, moisturizing, flavouring.It is medical former
Material sodium lactate solution can be used as alkaline sodium salt, can be used as injection applied to medical field, major function is supplement body fluid
It is balanced with people's cylinder electrolyte is adjusted, caused by dehydration caused by sodium lactate injection can be released because of diarrhea and diabetes and gastritis
Poisoning.Sodium lactate is used as Green's injection, is used as treatment metabolic acidosis；Sodium lactate is used to supplement body in parenteral/solution
Liquid or electrolyte, are widely used in peritoneal dialysis solution.
CN99116651.5 is related to process for preparing sodium lactate, uses edible lactic acid or fine purification of lactic acid for raw material, with ester salt
Legal system takes sodium lactate, and basic technology is divided into three steps, the first step, with edible lactic acid or fine purification of lactic acid and alcohol compound first
Alcohol, ethyl alcohol or the mixing of butanol any one, esterification occurs under the conditions of certain temperature and pressure, it is mixed to generate lactic acid ester
Object is closed, second step makes lactic acid ester and sodium carbonate or sodium hydroxide carry out the saponification of equimolar ratio under the conditions of certain temperature
Reaction, produces primary sodium lactate, third step, and primary sodium lactate adjusts its pH value and contain after absorption, decoloration, exchange purification
Measure sodium lactate finished product.Contain the alcohols materials such as remaining methanol, ethyl alcohol in the sodium lactate product of this technique production.
CN200610009657.X is related to extraction and method for concentration and its device of a kind of sodium lactate, it be in order to solve from
There are problems that fouling membrane in the conventional electrodialysis method of extraction and concentrating sodium lactate in garbage fermentation liquid, using frequently pole-reversing electricity
The method of dialysis.This technique is using electrodialytic method, and there is that can not amplify, industrialized production there is a problem of larger.
CN200910188147.7 is related to a kind of preparation method of fine purification of lactic acid sodium, especially mentions from calcium lactate fermentation solution
The method for taking and preparing fine purification of lactic acid sodium.The method of the present invention is reacted using double salt precipitation, so that calcium lactate is converted into sodium lactate, simultaneously
By-product calcium carbonate or calcium hydroxide, and binding resin purification, film filtering and electrodialytic technique obtain fine purification of lactic acid sodium.Cream will be contained
The by-product calcium carbonate or calcium hydroxide of acid group continue cycling through use as neutralizer.This technique is made using fermentation liquid calcium lactate
For raw material, the impurity such as the product carbohydrate of fermentation, protein are more, and subsequent technique is complicated, uses electrodialysis process step, Wu Fafang
Greatly, industrialized production is difficult, and the handicraft product yield is lower.
CN201610827669.7 is related to a kind of technique that sodium lactate is produced from lactic fermentation liquid.Using extracting-back extraction
The method taken has directly produced crude lactic acid sodium solution from lactic fermentation liquid, then removes crude lactic acid by modified D201 macroreticular resin
The micro Dextrose production that contains in the sodium solution sodium lactate solution of higher degree.The technique uses lactic fermentation liquid as original
Material, the impurity of raw material are more；Using the method for extraction and back extraction, there are the residual such as extractant and strippant in the product of production,
In addition this process industry metaplasia produces difficult, and product yield is low.
Summary of the invention
In order to solve the above technical problem, the present invention provides a kind of production method of medical sodium lactate solution, this method is obtained
The sodium lactate solution arrived, impurity content is low, and product purity is high, can be used as bulk pharmaceutical chemicals sodium lactate solution production sodium lactate injection,
Peritoneal dialysis solution etc..
It adopts the technical scheme that, a kind of production method of medical sodium lactate solution, comprising the following steps:
1) using food grade lactic acid as raw material, concentrated and short-range molecular distillation obtains the lactic acid of resistance to thermal level；
2) water and sodium hydroxide solution is added to react the lactic acid of resistance to thermal level, until the pH of reaction solution is 7.5-8.5；
3) activated carbon adsorption decolorization is added, is then allowed to stand processing；The pH value for adjusting mixture again is 7.8-8.2；Most
Sodium lactate mass fraction is obtained in the solution of 60%-75% after carrying out coarse filtration, refined filtration and concentration afterwards.
Further, the food grade lactic acid obtains resistance to thermal level cream by luwa evaporator concentration and short-range molecular distillation
Acid, wherein the mass concentration for the lactic acid of resistance to thermal level be 99% or more, lactic acid be heated to reflux at 180-200 DEG C 2 hours colorations≤
50APHA.80.0% or more food grade lactic acid mass content allows to have a small amount of impurity；The lactic acid of resistance to thermal level is high-purity lactic acid.
Further, the mass concentration of the sodium hydroxide is 30-32%, the hydrogen being electrolysed using sodium-chloride water solution
Sodium oxide molybdena product, product meet the requirement of GB/T11199 national Specification.
Further, the active carbon is injection-use activated carbon, and additional amount is the 1.0-1.5% of lactic acid quality.Removal
The substances such as pigment and bacterial endotoxin.
Further, the time of repose is 2-4 hours；In favor of the lactic anhydride and lact-acid oligomer depolymerization and hydrogen in lactic acid
Sodium oxide molybdena adequately reacts.When adjusting pH, it is adjusted using lactic acid or sodium hydroxide.
Further, when the coarse filtration, using PAE accurate filter, the active carbon and visible foreign of the overwhelming majority are filtered；
When refined filtration, using purpose ceramic-film filter, nano-scale particle is filtered.PAE is filtered into be filtered for nylon or polyethylene chimney filter, and aperture is
0.3 micron or less.Ceramic membrane is with titanium oxide, cobalt oxide etc. through having the secondary filter material of porous structure made of high temperature sintering
Material, aperture are 1 nanometer -300 nanometers.
It further, is vacuum concentration when concentration, using luwa evaporator.
Further, sodium lactate mass fraction is obtained after concentration to be added pure in the solution of 60%-75% according to user's needs
Change water and blend into required concentration, the solution after blending removes bacterial endotoxin substance.
Further, the solution after blending removes bacterial endotoxin substance using ultrafiltration membrane.The work before activated carbon adsorption
On the basis of section, bacterial endotoxin in product is further removed using ultrafiltration, the aperture of ultrafiltration membrane is 3 nanometers -15 nanometers.
Reaction equation of the present invention is: CH3CHOHCOOH+NaOH=CH3CHOHCOONa+H2O。
The present invention to feed purification, raw material selection and reaction, activated carbon adsorption, standing, filtering, concentration, depyrogenation filter,
The entire production process such as packaging has carried out the complete explanation of system.It is comprehensively careful to elaborate a kind of pharmaceutical grade sodium lactate
The production method of solution, purity higher sodium hydroxide low using high-purity lactic acid and impurity content are reacted, and are controlled from source
The introducing of the impurity contents such as sugaring class, heavy metal.It is below using removable 300 nanometers of PAE secondary filter and ceramic membrane filter
Visible foreign guarantees the clear of sodium lactate solution finished product.Using ultrafiltration membrance filter step, finished product sodium lactate solution can remove
Middle bacterial endotoxin meets requirement of the peritoneal dialysis solution to lactic acid sodium raw materials.
The present invention has the following advantages that and effect:
1, it is reacted with the sodium hydroxide solution raw material of the lactic acid of resistance to thermal level of high-purity and high-purity, material purity
Height, impurity content is low, and it is low to be allowed to product impurity content.It avoids raw material from introducing impurity and causes subsequent step removal difficult.
2, after using activated carbon adsorption decolorization, increase and stand workshop section, lactic acid and sodium hydroxide can be made to have adequately
Time is reacted, and thoroughly, product stability is good for reaction；
3, whole activity can remove using PAE accurate filter and purpose ceramic-film filter by coarse filtration and refined filtration technique
Charcoal and visible foreign.
4, after the sodium lactate solution for blending to obtain required concentration, increase depyrogenation filtration step, remove bacterial endotoxin,
Product is set to reach pharmacopeia grade standard.Product purity is high, and impurity content is low, can be used as bulk pharmaceutical chemicals sodium lactate solution production sodium lactate note
Penetrate liquid, peritoneal dialysis solution etc..
Specific embodiment
Below with reference to embodiment, the present invention is furture elucidated.
Embodiment 1:
1, lactic acid purifies: food grade lactic acid is concentrated by knifing and short-range molecular distillation, obtains the resistance to thermal level cream of sufficient amount
Acid, concentration 99.9wt%.Food grade lactic acid content 80% allows to present faint yellow there are a small amount of organic impurities.It is heat-resisting
Grade lactic acid appearance is colorless and transparent thick liquid, and 200 DEG C are heated to reflux 2 hours coloration≤50APHA
2, it reacts: the lactic acid of resistance to thermal level (99.9%) 1000KG being first transported to reactor tank, purifying is added under stirring
Water 250KG is slowly added to 30wt% sodium hydroxide solution about 1460KG and carries out neutralization reaction, stops when reaction solution pH value is 8.0
Only react；
3, activated carbon adsorption: the injection-use activated carbon that 10KG is added in the solution after reaction carries out adsorption bleaching；
4, it stands: because containing the polymeric materials such as lactic anhydride in lactic acid, standing 2 hours, mixture further reacts, active carbon
Further decolorization adsorption；
5, it adjusts pH value: 30% sodium hydroxide solution about 25KG is added, adjusting reaction mixture pH value is 7.80, newborn at this time
Acid sodium solution content is about 47.0%；
6, PAE coarse filtration: the sodium lactate feed liquid that reaction decolorization adsorption is completed is pumped into PAE accurate filter and is filtered, removes
Active carbon may mixed solid formation impurity；
7, inorganic ceramic membrane refined filtration: enter inorganic ceramic membrane by the sodium lactate feed liquid that PAE is filtered and be filtered, further
Removal active carbon；
8, it is concentrated: under the conditions of vacuum -0.093MPa, it is dense that above-mentioned dilute sodium lactate solution being pumped into luwa evaporator progress
Contracting is heated under the conditions of vacuum -0.093MPa, jacket steam pressure 0.15MPa, and the content of sodium lactate solution is after concentration
61.3%；
9, blend: the purified water of 34KG is added in the sodium lactate solution after concentration, blends the content to 60.3%, reinspection cream
Acid sodium solution pH value is 7.20；
10, depyrogenation filters: blending the sodium lactate solution of completion, is pumped into depyrogenation filter, removes bacterial endotoxin object
It is filling after matter, obtain 2060KG sodium lactate finished product.
Embodiment two
1, lactic acid purifies: food grade lactic acid is concentrated by knifing and short-range molecular distillation, obtains the resistance to thermal level cream of sufficient amount
Acid, concentration are 99.9% mass ratio；
2, it reacts: the lactic acid of resistance to thermal level (99.9%) 2000KG being first transported to reactor tank, purifying is added under stirring
Water 500KG is slowly added to 30% sodium hydroxide solution about 2960KG and carries out neutralization reaction, stops when reaction solution pH value is 8.4
Reaction；
3, activated carbon adsorption: the injection-use activated carbon that 20KG is added in the solution after reaction carries out adsorption bleaching；
4, it stands: because containing the polymeric materials such as lactic anhydride in lactic acid, standing 4 hours, mixture further reacts, active carbon
Further decolorization adsorption；
5, it adjusts pH value: 30% sodium hydroxide solution about 5KG is added, adjusting reaction mixture pH value is 8.50, newborn at this time
Acid sodium solution content is about 47.2%；
6, PAE coarse filtration: the sodium lactate feed liquid that reaction decolorization adsorption is completed is pumped into PAE accurate filter and is filtered, removes
Active carbon may mixed solid formation impurity；
7, inorganic ceramic membrane refined filtration: enter inorganic ceramic membrane by the sodium lactate feed liquid that PAE is filtered and be filtered, further
Removal active carbon；
8, it is concentrated: under the conditions of vacuum -0.093MPa, it is dense that above-mentioned dilute sodium lactate solution being pumped into luwa evaporator progress
Contracting is heated under the conditions of vacuum -0.093MPa, jacket steam pressure 0.15MPa, and the content of sodium lactate solution is after concentration
60.6%；
9, blend: the purified water of 10KG is added in the sodium lactate solution after concentration, blends the content to 60.3%；
10, depyrogenation filters: blending the sodium lactate solution of completion, is pumped into depyrogenation filter, removes bacterial endotoxin object
It is filling after matter, obtain 4120KG sodium lactate finished product.
Embodiment three
1, lactic acid purifies: food grade lactic acid is concentrated by knifing and short-range molecular distillation, obtains the resistance to thermal level cream of sufficient amount
Acid, concentration are 99.9% mass ratio；
2, it reacts: the lactic acid of resistance to thermal level (99.9%) 2000KG being first transported to reactor tank, purifying is added under stirring
Water 500KG is slowly added to 30% sodium hydroxide solution about 2955KG and carries out neutralization reaction, stops when reaction solution pH value is 8.2
Reaction；
3, activated carbon adsorption: the injection-use activated carbon that 20KG is added in the solution after reaction carries out adsorption bleaching；
4, it stands: because containing the polymeric materials such as lactic anhydride in lactic acid, standing 3 hours, mixture further reacts, active carbon
Further decolorization adsorption；
5, it adjusts pH value: 30% sodium hydroxide solution about 15KG is added, adjusting reaction mixture pH value is 8.40, newborn at this time
Acid sodium solution content is about 46.8%；
6, PAE coarse filtration: the sodium lactate feed liquid that reaction decolorization adsorption is completed is pumped into PAE accurate filter and is filtered, removes
Active carbon may mixed solid formation impurity；
7, inorganic ceramic membrane refined filtration: enter inorganic ceramic membrane by the sodium lactate feed liquid that PAE is filtered and be filtered, further
Removal active carbon；
8, it is concentrated: under the conditions of vacuum -0.093MPa, it is dense that above-mentioned dilute sodium lactate solution being pumped into luwa evaporator progress
Contracting is heated under the conditions of vacuum -0.093MPa, jacket steam pressure 0.15MPa, and the content of sodium lactate solution is after concentration
62.0%；
9, blend: the purified water of 110KG is added in the sodium lactate solution after concentration, blends the content to 60.3%；
10, depyrogenation filters: blending the sodium lactate solution of completion, is pumped into depyrogenation filter, removes bacterial endotoxin object
It is filling after matter, obtain 4118KG sodium lactate finished product.
Product quality, purity and impurity content detection data in above-described embodiment is as shown in table 1 below.
Table 1
The above embodiments are only the preferred technical solution of the present invention, and are not construed as limitation of the invention, this hair
Bright protection scope should be with the technical solution of claim record, technical characteristic in the technical solution recorded including claim
Equivalents are protection scope.Equivalent replacement i.e. within this range is improved, also within protection scope of the present invention.
Claims (9)
1. a kind of production method of medical sodium lactate solution, which comprises the following steps:
1) using food grade lactic acid as raw material, concentrated distillation obtains the lactic acid of resistance to thermal level；
2) water and sodium hydroxide solution is added to react the lactic acid of resistance to thermal level, until the pH of reaction solution is 7.5-8.5；
3) activated carbon adsorption decolorization is added, is then allowed to stand processing；The pH value for adjusting mixture again is 7.8-8.2；It is most laggard
Sodium lactate mass fraction is obtained after row coarse filtration, refined filtration and concentration in the solution of 60%-75%.
2. according to the method described in claim 1, it is characterized by: the food grade lactic acid by luwa evaporator concentration and it is short
Journey molecular distillation obtains the lactic acid of resistance to thermal level, wherein the mass concentration for the lactic acid of resistance to thermal level is 99% or more, lactic acid adds at 180-200 DEG C
2 hours coloration≤50APHA of heat reflux.
3. according to the method described in claim 1, it is characterized by: the mass concentration of the sodium hydroxide is 30-32%, use
The sodium hydroxide product that sodium-chloride water solution is electrolysed, product meet the requirement of GB/T11199 national Specification.
4. according to the method described in claim 1, additional amount is it is characterized by: the active carbon is injection-use activated carbon
The 1.0-1.5% of lactic acid quality.
5. according to the method described in claim 1, it is characterized by: the time of repose is 2-4 hours；When adjusting pH, use
Lactic acid or sodium hydroxide are adjusted.
6. according to the method described in claim 1, it is characterized by: when the coarse filtration, using PAE accurate filter；When refined filtration,
Using purpose ceramic-film filter.
7. according to the method described in claim 1, it is characterized by: being vacuum concentration when being concentrated, using luwa evaporator.
8. method described in -7 any one according to claim 1, it is characterised in that: obtain sodium lactate mass fraction after concentration and exist
The solution of 60%-75% adds purified water to blend into required concentration according to user's needs, and the solution after blending removes bacterium
Endotoxin substance.
9. according to the method described in claim 8, it is characterized by: the solution after blending removes bacterium endogenous toxic material using ultrafiltration membrane
Plain substance.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110551018A (en) * | 2019-07-29 | 2019-12-10 | 武汉新奇华清膜分离技术工程有限公司 | Method for preparing sodium lactate by using lactic acid distillation residual liquid |
| CN112812004A (en) * | 2020-12-25 | 2021-05-18 | 蚌埠丰原涂山制药有限公司 | Industrial preparation method of sodium lactate solution |
| CN115737548A (en) * | 2022-11-21 | 2023-03-07 | 四川汇宇制药股份有限公司 | Preparation method of famotidine injection |
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| CN107986956A (en) * | 2017-12-28 | 2018-05-04 | 九江科院生物化工有限公司 | A kind of method for preparing calcium lactate crystal and the method by the calcium lactate crystal production lactic acid of resistance to thermal level |
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| CN1270953A (en) * | 2000-03-20 | 2000-10-25 | 湖北省广水市民族化工有限公司 | Short-path molecular distillation process for refining lactic acid |
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| CN110551018A (en) * | 2019-07-29 | 2019-12-10 | 武汉新奇华清膜分离技术工程有限公司 | Method for preparing sodium lactate by using lactic acid distillation residual liquid |
| CN112812004A (en) * | 2020-12-25 | 2021-05-18 | 蚌埠丰原涂山制药有限公司 | Industrial preparation method of sodium lactate solution |
| CN112812004B (en) * | 2020-12-25 | 2023-09-29 | 蚌埠丰原涂山制药有限公司 | Industrial preparation method of sodium lactate solution |
| CN115737548A (en) * | 2022-11-21 | 2023-03-07 | 四川汇宇制药股份有限公司 | Preparation method of famotidine injection |
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