CN107115280A - A kind of aminocaproic acid parenteral solution and preparation method thereof - Google Patents
A kind of aminocaproic acid parenteral solution and preparation method thereof Download PDFInfo
- Publication number
- CN107115280A CN107115280A CN201610105045.4A CN201610105045A CN107115280A CN 107115280 A CN107115280 A CN 107115280A CN 201610105045 A CN201610105045 A CN 201610105045A CN 107115280 A CN107115280 A CN 107115280A
- Authority
- CN
- China
- Prior art keywords
- filtered
- preparation
- aminocaproic acid
- added
- fin
- Prior art date
- 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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Links
- SLXKOJJOQWFEFD-UHFFFAOYSA-N 6-aminohexanoic acid Chemical compound NCCCCCC(O)=O SLXKOJJOQWFEFD-UHFFFAOYSA-N 0.000 title claims abstract description 20
- 229960002684 aminocaproic acid Drugs 0.000 title claims abstract description 20
- 238000002360 preparation method Methods 0.000 title claims abstract description 19
- 239000003182 parenteral nutrition solution Substances 0.000 title claims abstract description 15
- 239000004576 sand Substances 0.000 claims abstract description 8
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 8
- 239000008215 water for injection Substances 0.000 claims abstract description 8
- 239000003814 drug Substances 0.000 claims abstract description 4
- 239000000543 intermediate Substances 0.000 claims abstract description 4
- 238000005070 sampling Methods 0.000 claims abstract description 4
- 230000001954 sterilising effect Effects 0.000 claims abstract description 4
- 238000003756 stirring Methods 0.000 claims abstract description 4
- 239000004695 Polyether sulfone Substances 0.000 claims abstract 5
- 229920006393 polyether sulfone Polymers 0.000 claims abstract 5
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims description 10
- 241000894006 Bacteria Species 0.000 claims description 3
- 238000012544 monitoring process Methods 0.000 claims description 3
- 239000002245 particle Substances 0.000 claims description 3
- 230000003139 buffering effect Effects 0.000 claims 1
- 239000007788 liquid Substances 0.000 claims 1
- 238000000034 method Methods 0.000 abstract description 7
- 238000001914 filtration Methods 0.000 abstract description 3
- 229920012266 Poly(ether sulfone) PES Polymers 0.000 description 6
- 239000000047 product Substances 0.000 description 6
- 108010073385 Fibrin Proteins 0.000 description 3
- 102000009123 Fibrin Human genes 0.000 description 3
- BWGVNKXGVNDBDI-UHFFFAOYSA-N Fibrin monomer Chemical compound CNC(=O)CNC(=O)CN BWGVNKXGVNDBDI-UHFFFAOYSA-N 0.000 description 3
- 239000004472 Lysine Substances 0.000 description 3
- KDXKERNSBIXSRK-UHFFFAOYSA-N Lysine Natural products NCCCCC(N)C(O)=O KDXKERNSBIXSRK-UHFFFAOYSA-N 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 229950003499 fibrin Drugs 0.000 description 3
- 108010058861 Fibrin Fibrinogen Degradation Products Proteins 0.000 description 2
- 239000000208 fibrin degradation product Substances 0.000 description 2
- 230000020764 fibrinolysis Effects 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- 239000002994 raw material Substances 0.000 description 2
- 239000004475 Arginine Substances 0.000 description 1
- 108090000790 Enzymes Proteins 0.000 description 1
- 102000004190 Enzymes Human genes 0.000 description 1
- 108010049003 Fibrinogen Proteins 0.000 description 1
- 102000008946 Fibrinogen Human genes 0.000 description 1
- 108010088842 Fibrinolysin Proteins 0.000 description 1
- 101710196208 Fibrinolytic enzyme Proteins 0.000 description 1
- 208000032843 Hemorrhage Diseases 0.000 description 1
- 102000013566 Plasminogen Human genes 0.000 description 1
- 108010051456 Plasminogen Proteins 0.000 description 1
- 208000007536 Thrombosis Diseases 0.000 description 1
- 239000012190 activator Substances 0.000 description 1
- 230000001567 anti-fibrinolytic effect Effects 0.000 description 1
- 239000000504 antifibrinolytic agent Substances 0.000 description 1
- 229940082620 antifibrinolytics Drugs 0.000 description 1
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 description 1
- 208000034158 bleeding Diseases 0.000 description 1
- 231100000319 bleeding Toxicity 0.000 description 1
- 230000000740 bleeding effect Effects 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 229940088598 enzyme Drugs 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 229940012952 fibrinogen Drugs 0.000 description 1
- 229940001501 fibrinolysin Drugs 0.000 description 1
- 230000000025 haemostatic effect Effects 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 230000008092 positive effect Effects 0.000 description 1
- 108090000765 processed proteins & peptides Proteins 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
Classifications
-
- 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
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
-
- 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
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Dermatology (AREA)
- Inorganic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention discloses a kind of aminocaproic acid parenteral solution and preparation method thereof, this method comprises the following steps：(1) water for injection newly boiled of amount of preparation 50% is added in dense preparing tank, aminocaproic acid, stirring and dissolving is added；Filter is returned to after clear and bright with Suzhou sand rod, is filtered in dilute preparing tank；(2) water for injection is added to full dose, is stirred 15 minutes, is made it uniform, adjusts pH；(3) returned and filtered to clear and bright with Suzhou sand stick, 0.45 μm and 0.22 μm of polyether sulfone fin；(4) sampling and testing intermediates content and pH value, it is every it is qualified after, decoction is filtered into receiver；(5) after the decoction in receiver is filtered through multiple 0.22 μm of polyether sulfone fin, filling surge tank is inputted for filling；(6) embedding；(7) sterilize, sterilising temp is 100 DEG C, the time is 30 minutes.Present invention employs secondary aseptic filtration, overall process is sterile, reduces the visible foreign matters of medicine, it is ensured that product quality.
Description
Technical field
The present invention relates to a kind of aminocaproic acid parenteral solution and preparation method thereof.
Background technology
Aminocaproic acid is antifibrinolytics.Fibrinogen passes through the lysine in its molecular structure
Binding site is specifically combined with fibrin, is then changed into fibrinolysin under activator effect, the enzyme
Arginine and lysine peptide chain in fibrin can be cracked, fibrin degradation product (FDP) is formed, makes blood clot
Dissolving.Chemical constitution is similar to lysine, qualitative plasminogen can be prevented to be combined with fibrin, prevented
It is activated, so as to suppress fibrinolysis, high concentration (100mg/L) then directly suppresses fibrinolytic enzyme activity
Power, reaches haemostatic effect.Aminocaproic acid parenteral solution is used for suitable for preventing and treating fibrinolysis
Various bleedings caused by hyperfunction.However, containing foreign matter in existing aminocaproic acid parenteral solution, production have impact on
Quality.
The content of the invention
The technical problems to be solved by the invention are to overcome in existing aminocaproic acid parenteral solution containing different
Thing, there is provided a kind of aminocaproic acid parenteral solution and preparation method thereof for the not high defect of product quality.This hair
Secondary aseptic filtration is employed in the preparation method of bright aminocaproic acid parenteral solution, overall process is sterile, reduces
The visible foreign matters of medicine, it is ensured that product quality.
The present invention solves above-mentioned technical problem by following technical proposals.
The invention provides a kind of preparation method of aminocaproic acid parenteral solution, it comprises the following steps：
(1) water for injection newly boiled of amount of preparation 50% is added in dense preparing tank, aminocaproic acid is added,
Stirring and dissolving；Filter is returned to after clear and bright with Suzhou sand rod, is filtered in dilute preparing tank；
(2) water for injection is added to full dose, is stirred 15 minutes, is made it uniform, adjusts pH；
(3) returned and filtered to clear and bright with Suzhou sand stick, 0.45 μm and 0.22 μm of polyether sulfone (PES) fin；
(4) sampling and testing intermediates content and pH value, it is every it is qualified after, decoction is filtered into receiver；
(5) after the decoction in receiver is filtered through multiple 0.22 μm of polyether sulfone (PES) fin, input
Filling surge tank is for filling；
(6) embedding；
(7) sterilize, sterilising temp is 100 DEG C, the time is 30 minutes.
In step (2), the pH can be preferably adjusted with watery hydrochloric acid.The watery hydrochloric acid is ability
The conventional use of watery hydrochloric acid in domain.
In step (5), while the decoction is filtered through multiple 0.22 μm of polyether sulfone (PES) fin
It is preferably also crucial to the suspended particles of background environment, settling bacteria and laminar flow wind speed, flcating germ etc. to control
Project enters Mobile state monitoring, and overall process is sterile, it is ensured that product quality.
Present invention also offers one kind aminocaproic acid parenteral solution as made from above-mentioned preparation method.
On the basis of common sense in the field is met, above-mentioned each optimum condition can be combined, produce this hair
Bright each preferred embodiments.
Agents useful for same and raw material of the present invention are commercially available.
The positive effect of the present invention is：Secondary aseptic filtration is employed in the preparation method of the present invention,
Overall process is sterile, reduces the visible foreign matters of medicine, it is ensured that product quality.
Embodiment
The present invention is further illustrated below by the mode of embodiment, but is not therefore limited the present invention to
Among described scope of embodiments.The experimental method of unreceipted actual conditions in the following example, according to normal
Rule method and condition, or selected according to catalogue.
In following embodiments, raw materials used material is commercially available.Percentage used is mass percent.
Embodiment 1
A kind of preparation method of aminocaproic acid parenteral solution, it comprises the following steps：
(1) water for injection newly boiled of amount of preparation 50% is added in dense preparing tank, aminocaproic acid is added,
Stirring and dissolving；Filter is returned to after clear and bright with Suzhou sand rod, is filtered in dilute preparing tank；
(2) water for injection is added to full dose, is stirred 15 minutes, is made it uniform, pH is adjusted with watery hydrochloric acid；
(3) returned and filtered to clear and bright with Suzhou sand stick, 0.45 μm and 0.22 μm of polyether sulfone (PES) fin；
(4) sampling and testing intermediates content and pH value, it is every it is qualified after, decoction is filtered into receiver；
(5) after the decoction in receiver is filtered through multiple 0.22 μm of polyether sulfone (PES) fin, input
Filling surge tank is for filling；This step decoction is filtered through multiple 0.22 μm of polyether sulfone (PES) fin,
And the suspended particles of background environment, settling bacteria and laminar flow wind speed, flcating germ etc. are closed simultaneously in production
Key control project enters Mobile state monitoring, and overall process is sterile, it is ensured that product quality；
(6) embedding；
(7) sterilize, sterilising temp is 100 DEG C, the time is 30 minutes.
Effect example 1
Aminocaproic acid parenteral solution prepared by the present invention is free of foreign matter, and product quality is high.
Claims (4)
1. a kind of preparation method of aminocaproic acid parenteral solution, it is characterised in that the preparation method includes
Following steps：
(1) water for injection newly boiled of amount of preparation 50% is added in dense preparing tank, aminocaproic acid is added,
Stirring and dissolving；Filter is returned to after clear and bright with Suzhou sand rod, is filtered in dilute preparing tank；
(2) water for injection is added to full dose, is stirred 15 minutes, is made it uniform, adjusts pH；
(3) returned and filtered to clear and bright with Suzhou sand stick, 0.45 μm and 0.22 μm of polyether sulfone fin；
(4) sampling and testing intermediates content and pH value, it is every it is qualified after, decoction is filtered into receiver；
(5) after the decoction in receiver is filtered through multiple 0.22 μm of polyether sulfone fin, filling buffering is inputted
Tank is for filling；
(6) embedding；
(7) sterilize, sterilising temp is 100 DEG C, the time is 30 minutes.
2. preparation method as claimed in claim 1, it is characterised in that in step (2), the pH
It is adjusted with watery hydrochloric acid.
3. preparation method as claimed in claim 1, it is characterised in that in step (5), the medicine
Liquid while filtered through multiple 0.22 μm of polyether sulfone fin also to the suspended particles of background environment, settling bacteria,
Laminar flow wind speed and flcating germ enter Mobile state monitoring.
4. aminocaproic acid parenteral solution made from a kind of preparation method as any one of claim 1-3.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610105045.4A CN107115280A (en) | 2016-02-25 | 2016-02-25 | A kind of aminocaproic acid parenteral solution and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610105045.4A CN107115280A (en) | 2016-02-25 | 2016-02-25 | A kind of aminocaproic acid parenteral solution and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN107115280A true CN107115280A (en) | 2017-09-01 |
Family
ID=59717522
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201610105045.4A Pending CN107115280A (en) | 2016-02-25 | 2016-02-25 | A kind of aminocaproic acid parenteral solution and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN107115280A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108685843A (en) * | 2018-05-31 | 2018-10-23 | 常州兰陵制药有限公司 | aminocaproic acid injection and preparation method thereof |
| CN112516082A (en) * | 2020-12-31 | 2021-03-19 | 常州兰陵制药有限公司 | Amino caproic acid injection and preparation method thereof |
-
2016
- 2016-02-25 CN CN201610105045.4A patent/CN107115280A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108685843A (en) * | 2018-05-31 | 2018-10-23 | 常州兰陵制药有限公司 | aminocaproic acid injection and preparation method thereof |
| CN108685843B (en) * | 2018-05-31 | 2019-08-06 | 常州兰陵制药有限公司 | Aminocaproic acid injection and preparation method thereof |
| CN112516082A (en) * | 2020-12-31 | 2021-03-19 | 常州兰陵制药有限公司 | Amino caproic acid injection and preparation method thereof |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| WD01 | Invention patent application deemed withdrawn after publication | ||
| WD01 | Invention patent application deemed withdrawn after publication |
Application publication date: 20170901 |