CN105287366B - A kind of vitamin K 1 injection and preparation method thereof - Google Patents
A kind of vitamin K 1 injection and preparation method thereof Download PDFInfo
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- CN105287366B CN105287366B CN201410271850.5A CN201410271850A CN105287366B CN 105287366 B CN105287366 B CN 105287366B CN 201410271850 A CN201410271850 A CN 201410271850A CN 105287366 B CN105287366 B CN 105287366B
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Abstract
The invention discloses a kind of vitamin K 1 injection and preparation method thereof, is formulated by active component vitamin K1, auxiliary material and water for injection, takes the water for injection of 80% formula ratio, adds anhydrous sodium acetate, obtains solution A；The vitamin K1 of formula ratio, HS15 are weighed successively to totally without in water receptacle, emulsification it is uniform solution B；Solution A is slowly added into solution B, then adds sodium pyrosulfite, is stirred, then adjusts pH to 5.8~6.2 with glacial acetic acid；The full dose of formula ratio is added water for injection to, is filtered, through 121 DEG C of rotations sterilizing 12 minutes or sterile preparation methods after nitrogen charging embedding, is produced.Product made of the present invention not only conforms with vitamin K 1 injection standards of pharmacopoeia but also drastically increases product clarity compared with existing vitamin K 1 injection.
Description
Technical field
The present invention relates to pharmaceutical preparation technology field, more particularly to a kind of vitamin K 1 injection and preparation method thereof.
Background technology
Vitamin K1 is：2- methyl -3-（3,7,11,15- tetramethyl -2- hexadecene bases）- 1,4- naphthalenediones it is trans
With the mixture of cis-isomer.HS-15 is：15-hydroxy polyethylene glycol stearate.Vitamin K 1 injection is used for vitamin
Ischemic caused by K shortages, the institute such as bleeding, Coumarins, sodium salicylate as caused by obstruction stickiness jaundice, leak, chronic diarrhea etc.
Vitamin K deficiency inside caused by the Hypoprothrombinemia of cause, hemorrhage of newborn and prolonged application broad-spectrum antibiotic.
Vitamin K 1 injection is one of clinical commonly used drug, on May 31,1 day to 2011 January in 2004, national drug
There is vitamin K 1 injection serious adverse reaction/event to report 893 in the case report data base of adverse reaction monitoring center, its
Middle anaphylactic shock 328（Account for 36.7%）, severe allergic reaction is vitamin K1 adverse reaction the most prominent, 2011 12
The State Food and Drug Administration's issue of the moon 26 bulletin reminds the severe allergic reaction of concern vitamin K 1 injection..
The patent application of application number 201310416999.3 discloses a kind of vitamin K 1 injection and preparation method thereof, though
Confirmation is studied, using 15-hydroxy polyethylene glycol stearate（Also known as HS15, referred to as
HS15）Do vitamin K 1 injection security made of solubilizer and be better than commercially available vitamin K 1 injection, but be used as injection
It still has the space further improved in terms of clarity.
The content of the invention
Present invention aims at provide a kind of prescription that can prepare the higher vitamin K 1 injection of quality and preparation
Technique.The auxiliary material kind of the invention compared with the patented invention of application number 201310416999.3, used in vitamin K 1 injection
Class is reduced, and the auxiliary material propane diols for being also easy to produce hemolytic and anaphylaxis side effect is removed, although the HS15 of price costly is used
Patented invention of the amount higher than 201310416999.3, but HS15 high security has been found, therefore this hair in theory
Bright product has higher clinical application security；Testing simultaneously confirms the vitamin K 1 injection product of the invention prepared clear
It is higher than the patented invention product of application number 201310416999.3 in terms of lightness.
To achieve these goals, the present invention adopts the following technical scheme that：
A kind of vitamin K 1 injection, it is characterised in that by the preparation of active component vitamin K1, auxiliary material and water for injection
Into the vitamin K 1 injection pH value is 5.8~6.2.
The auxiliary material is：（1）As the 15-hydroxy polyethylene glycol stearate of solubilizer,（2）Vinegar as pH adjusting agent
Hydrochlorate buffering pair,（3）Sodium pyrosulfite as antioxidant.
The acetate salt buffer is to for anhydrous sodium acetate-glacial acetic acid.
The dosage of the active component and auxiliary material is as follows：Vitamin K1 is 10.0g/L, 15- hydroxy stearate acid polyethylene glycols
Ester is 71.0g/L~80.0 g/L, anhydrous sodium acetate 10.0g/L, sodium pyrosulfite 3.0g/L, and pH is adjusted using glacial acetic acid
It is worth for 5.8~6.2.
Vitamin K 1 injection of the present invention uses following preparation method：
The water for injection of 80% formula ratio is taken, adds the anhydrous sodium acetate of formula ratio, dissolving stirs, and obtains solution A；According to
The secondary vitamin K1 for weighing formula ratio, HS15 are to totally without in water receptacle, stirring, it is emulsified uniform solution B completely；Will be molten
Liquid A is slowly added into solution B, stirring while adding, after stirring completely, adds the sodium pyrosulfite of formula ratio, stirring
Uniformly, then pH to 5.8~6.2 is adjusted with glacial acetic acid；The full dose of formula ratio is added water for injection to, is filtered, after nitrogen charging embedding
Through 121 DEG C of rotations sterilizing 12 minutes or sterile preparation methods, produce.
The advantageous effects of the present invention are：
By removing cosolvent and increasing the dosage of solubilizer 15-hydroxy polyethylene glycol stearate, change solution system
System, so as to reach the technique effect that vitamin K 1 injection of the present invention has higher clinical pharmaceutical safety.
Embodiment
Embodiment 1
800ml waters for injection are measured, add 10.0g anhydrous sodium acetates, dissolving stirs, and obtains solution A；Weigh successively
10.0g vitamin K1s（It is pure）, 71.0gHS15 to totally without in water receptacle, stirring, it is emulsified uniform solution B completely；Will
Solution A is slowly added into solution B, stirring while adding, after stirring completely, adds 3.0g sodium pyrosulfites, stirring is equal
Even, then glacial acetic acid adjusts pH to 6.03；1000ml is added water for injection to, is filtered, is sterilized after nitrogen charging embedding through 121 DEG C of rotations
12 minutes, produce.（Specification：1ml∶10mg）
Embodiment 2
800ml waters for injection are measured, add 10.0g anhydrous sodium acetates, dissolving stirs, and obtains solution A；Weigh successively
10.0g vitamin K1s（It is pure）, 71.0gHS15 to totally without in water receptacle, stirring, it is emulsified uniform solution B completely；Will
Solution A is slowly added into solution B, stirring while adding, after stirring completely, adds 3.0g sodium pyrosulfites, stirring is equal
Even, then glacial acetic acid adjusts pH to 6.03；1000ml is added water for injection to, is filtered, nitrogen charging embedding, is through the preparation of sterile preparation method
.（Specification：1ml∶10mg）
Embodiment 3
800ml waters for injection are measured, add 10.0g anhydrous sodium acetates, dissolving stirs, and obtains solution A；Weigh successively
10.0g vitamin K1s（It is pure）, 75.0gHS15 to totally without in water receptacle, stirring, it is emulsified uniform solution B completely；Will
Solution A is slowly added into solution B, stirring while adding, after stirring completely, adds 3.0g sodium pyrosulfites, stirring is equal
Even, then glacial acetic acid adjusts pH to 6.00；1000ml is added water for injection to, is filtered, is sterilized after nitrogen charging embedding through 121 DEG C of rotations
12 minutes, produce.（Specification：1ml∶10mg）
Embodiment 4
800ml waters for injection are measured, add 10.0g anhydrous sodium acetates, dissolving stirs, and obtains solution A；Weigh successively
10.0g vitamin K1s（It is pure）, 75.0gHS15 to totally without in water receptacle, stirring, it is emulsified uniform solution B completely；Will
Solution A is slowly added into solution B, stirring while adding, after stirring completely, adds 3.0g sodium pyrosulfites, stirring is equal
Even, then glacial acetic acid adjusts pH to 6.00；1000ml is added water for injection to, is filtered, nitrogen charging embedding, is through the preparation of sterile preparation method
.（Specification：1ml∶10mg）
Embodiment 5
800ml waters for injection are measured, add 10.0g anhydrous sodium acetates, dissolving stirs, and obtains solution A；Weigh successively
10.0g vitamin K1s（It is pure）, 80.0gHS15 to totally without in water receptacle, stirring, it is emulsified uniform solution B completely；Will
Solution A is slowly added into solution B, stirring while adding, after stirring completely, adds 3.0g sodium pyrosulfites, stirring is equal
Even, then glacial acetic acid adjusts pH to 6.02；1000ml is added water for injection to, is filtered, is sterilized after nitrogen charging embedding through 121 DEG C of rotations
12 minutes, produce.（Specification：1ml∶10mg）
Embodiment 6
800ml waters for injection are measured, add 10.0g anhydrous sodium acetates, dissolving stirs, and obtains solution A；Weigh successively
10.0g vitamin K1s（It is pure）, 80.0gHS15 to totally without in water receptacle, stirring, it is emulsified uniform solution B completely；Will
Solution A is slowly added into solution B, stirring while adding, after stirring completely, adds 3.0g sodium pyrosulfites, stirring is equal
Even, then glacial acetic acid adjusts pH to 6.02；1000ml is added water for injection to, is filtered, nitrogen charging embedding, is through the preparation of sterile preparation method
.（Specification：1ml∶10mg）
Reference examples 1 are using the prescription of 201310416999.3 embodiment of patent document 1 and preparation technology as reference examples 1
800ml waters for injection are measured, add 10.0g anhydrous sodium acetates, dissolving stirs, and obtains solution A；Weigh successively
10.0g vitamin K1s（It is pure）, 50.0gHS15 and 20g.0g propane diols to totally without in water receptacle, stirring, make its breast completely
Change uniform solution B；Solution A is slowly added into solution B, it is stirring while adding, after stirring completely, it is burnt to add 3.0g
Sodium sulfite, stir, then glacial acetic acid regulation pH to 6.04；1000ml is added water for injection to, is filtered, after nitrogen charging embedding
Sterilize 12 minutes, produce through 121 DEG C of rotations.（Specification：1ml∶10mg）
Reference examples 2 are using the prescription of 201310416999.3 embodiment of patent document 2 and preparation technology as reference examples 2
800ml waters for injection are measured, add 10.0g anhydrous sodium acetates, dissolving stirs, and obtains solution A；Weigh successively
10.0g vitamin K1s（It is pure）, 50.0gHS15 and 20g.0g propane diols to totally without in water receptacle, stirring, make its breast completely
Change uniform solution B；Solution A is slowly added into solution B, it is stirring while adding, after stirring completely, it is burnt to add 3.0g
Sodium sulfite, stir, then glacial acetic acid regulation pH to 6.04；1000ml is added water for injection to, is filtered, nitrogen charging embedding,
Prepare and produce through sterile preparation method.（Specification：1ml∶10mg）
Reference examples 3 are using the prescription of 201310416999.3 embodiment of patent document 3 and preparation technology as reference examples 3
800ml waters for injection are measured, add 10.0g anhydrous sodium acetates, dissolving stirs, and obtains solution A；Weigh successively
10.0g vitamin K1s（It is pure）, 70.0gHS15 and 20g.0g propane diols to totally without in water receptacle, stirring, make its breast completely
Change uniform solution B；Solution A is slowly added into solution B, it is stirring while adding, after stirring completely, it is burnt to add 3.0g
Sodium sulfite, stir, then glacial acetic acid regulation pH to 6.03；1000ml is added water for injection to, is filtered, after nitrogen charging embedding
Sterilize 12 minutes, produce through 121 DEG C of rotations.（Specification：1ml∶10mg）
Reference examples 4 are using the prescription of 201310416999.3 embodiment of patent document 4 and preparation technology as reference examples 4
800ml waters for injection are measured, add 10.0g anhydrous sodium acetates, dissolving stirs, and obtains solution A；Weigh successively
10.0g vitamin K1s（It is pure）, 70.0gHS15 and 20g.0g propane diols to totally without in water receptacle, stirring, make its breast completely
Change uniform solution B；Solution A is slowly added into solution B, it is stirring while adding, after stirring completely, it is burnt to add 3.0g
Sodium sulfite, stir, then glacial acetic acid regulation pH to 6.03；1000ml is added water for injection to, is filtered, nitrogen charging embedding,
Prepare and produce through sterile preparation method.（Specification：1ml∶10mg）
Reference examples 5 are using the prescription of 201310416999.3 embodiment of patent document 5 and preparation technology as reference examples 5
800ml waters for injection are measured, add 10.0g anhydrous sodium acetates, dissolving stirs, and obtains solution A；Weigh successively
10.0g vitamin K1s（It is pure）, 70.0gHS15 and 25g.0g propane diols to totally without in water receptacle, stirring, make its breast completely
Change uniform solution B；Solution A is slowly added into solution B, it is stirring while adding, after stirring completely, it is burnt to add 3.0g
Sodium sulfite, stir, then glacial acetic acid regulation pH to 5.99；1000ml is added water for injection to, is filtered, after nitrogen charging embedding
Sterilize 12 minutes, produce through 121 DEG C of rotations.（Specification：1ml∶10mg）
Reference examples 6 are using the prescription of 201310416999.3 embodiment of patent document 6 and preparation technology as reference examples 6
800ml waters for injection are measured, add 10.0g anhydrous sodium acetates, dissolving stirs, and obtains solution A；Weigh successively
10.0g vitamin K1s（It is pure）, 70.0gHS15 and 25g.0g propane diols to totally without in water receptacle, stirring, make its breast completely
Change uniform solution B；Solution A is slowly added into solution B, it is stirring while adding, after stirring completely, it is burnt to add 3.0g
Sodium sulfite, stir, then glacial acetic acid regulation pH to 5.99；1000ml is added water for injection to, is filtered, nitrogen charging embedding,
Prepare and produce through sterile preparation method.（Specification：1ml∶10mg）
Reference examples 7 are using the prescription of 201310416999.3 embodiment of patent document 7 and preparation technology as reference examples 7
800ml waters for injection are measured, add 10.0g anhydrous sodium acetates, dissolving stirs, and obtains solution A；Weigh successively
10.0g vitamin K1s（It is pure）, 40.0gHS15 and 20g.0g propane diols to totally without in water receptacle, stirring, make its breast completely
Change uniform solution B；Solution A is slowly added into solution B, it is stirring while adding, after stirring completely, it is burnt to add 3.0g
Sodium sulfite, stir, then glacial acetic acid regulation pH to 6.01；1000ml is added water for injection to, is filtered, after nitrogen charging embedding
Sterilize 12 minutes, produce through 121 DEG C of rotations.（Specification：1ml∶10mg）
Reference examples 8 are using the prescription of 201310416999.3 embodiment of patent document 8 and preparation technology as reference examples 8
800ml waters for injection are measured, add 10.0g anhydrous sodium acetates, dissolving stirs, and obtains solution A；Weigh successively
10.0g vitamin K1s（It is pure）, 40.0gHS15 and 20g.0g propane diols to totally without in water receptacle, stirring, make its breast completely
Change uniform solution B；Solution A is slowly added into solution B, it is stirring while adding, after stirring completely, it is burnt to add 3.0g
Sodium sulfite, stir, then glacial acetic acid regulation pH to 6.01；1000ml is added water for injection to, is filtered, nitrogen charging embedding,
Prepare and produce through sterile preparation method.（Specification：1ml∶10mg）
Reference examples 9 are using the prescription of 201310416999.3 embodiment of patent document 9 and preparation technology as reference examples 9
800ml waters for injection are measured, add 10.0g anhydrous sodium acetates, dissolving stirs, and obtains solution A；Weigh successively
10.0g vitamin K1s（It is pure）, 40.0gHS15 and 25g.0g propane diols to totally without in water receptacle, stirring, make its breast completely
Change uniform solution B；Solution A is slowly added into solution B, it is stirring while adding, after stirring completely, it is burnt to add 3.0g
Sodium sulfite, stir, then glacial acetic acid regulation pH to 6.00；1000ml is added water for injection to, is filtered, after nitrogen charging embedding
Sterilize 12 minutes, produce through 121 DEG C of rotations.（Specification：1ml∶10mg）
Reference examples 10 are using the prescription of 201310416999.3 embodiment of patent document 10 and preparation technology as reference examples 10
800ml waters for injection are measured, add 10.0g anhydrous sodium acetates, dissolving stirs, and obtains solution A；Weigh successively
10.0g vitamin K1s（It is pure）, 40.0gHS15 and 25g.0g propane diols to totally without in water receptacle, stirring, make its breast completely
Change uniform solution B；Solution A is slowly added into solution B, it is stirring while adding, after stirring completely, it is burnt to add 3.0g
Sodium sulfite, stir, then glacial acetic acid regulation pH to 6.00；1000ml is added water for injection to, is filtered, nitrogen charging embedding,
Prepare and produce through sterile preparation method.（Specification：1ml∶10mg）
The clarity contrast experiment of experimental example 1
The comparison of clarity is carried out with 1-embodiment of embodiment 8 and 1-reference examples of reference examples 10
1. detection method foundation：《Chinese Pharmacopoeia》The H visible foreign matters inspection techniques of version annex Ⅸ in 2010
2. instrument and equipment：YB-3 type clarity detecting apparatus
3. detection method：Every batch of product is taken, cleans container outer wall, gently rotating and turn over that container makes can present in decoction
See that foreign matter suspends（It is careful not to decoction is produced bubble）, respectively under black and white background, hand-held test sample neck makes medicine
Liquid is gently overturn, and is surveyed with visual inspection（Illumination：1000~1500lx）.
4. criterion：Remove the fiber that smoke-like microparticle column, metal fillings, chips of glass, length or maximum particle diameter exceed 2mm
With the obvious alien material such as block.Only calculate fine visible foreign matters（Such as small particles, little crystallization etc.）, calculate qualification rate.
5. testing result is as shown in table 1
The clarity testing result of table 1
Note：Qualification rate=（Total quantity-obvious alien material-fine visible foreign matters）÷ total quantity × 100%
Conclusion：Vitamin K 1 injection clarity qualification rate prepared by the inventive method is apparently higher than patent
201310416999.3 vitamin K 1 injection prepared by inventive method.
Claims (1)
- A kind of 1. vitamin K 1 injection, it is characterised in that it is formulated by active component vitamin K1, auxiliary material and water for injection, The vitamin K 1 injection pH value is 5.8~6.2；The auxiliary material is：（1）The poly- second two of 15- hydroxy stearic acids as solubilizer Alcohol ester,（2）As the acetate salt buffer pair of pH adjusting agent,（3）Sodium pyrosulfite as antioxidant；The acetate salt buffer is to for anhydrous sodium acetate-glacial acetic acid；The dosage of the active component and auxiliary material is as follows：Vitamin K1 is 10.0g/L, and 15-hydroxy polyethylene glycol stearate is 71.0g/L~80.0 g/L, anhydrous sodium acetate 10.0g/L, sodium pyrosulfite 3.0g/L, use glacial acetic acid regulation pH value for 5.8~6.2；The preparation method of described vitamin K 1 injection is as follows：The water for injection of 80% formula ratio is taken, adds the anhydrous sodium acetate of formula ratio, dissolving stirs, and obtains solution A；The vitamin K1 of formula ratio, HS15 are weighed successively to totally without in water receptacle, stirring, it is emulsified uniform solution completely B；Solution A is slowly added into solution B, it is stirring while adding, after stirring completely, add the pyrosulfurous acid of formula ratio Sodium, stir, then adjust pH to 5.8~6.2 with glacial acetic acid；The full dose of formula ratio is added water for injection to, is filtered, nitrogen charging Through 121 DEG C of rotations sterilizing 12 minutes or sterile preparation methods after embedding, produce.
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| CN105997869A (en) * | 2016-06-17 | 2016-10-12 | 合肥华方医药科技有限公司 | Vitamin K1 micelle injection and preparation method thereof |
| CN114533672B (en) * | 2022-03-03 | 2023-12-26 | 南京臣功制药股份有限公司 | Vitamin K 1 Nanoemulsion and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103462887A (en) * | 2013-08-09 | 2013-12-25 | 张蕊 | Vitamin K1 injection and preparation method thereof |
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| CN103462887A (en) * | 2013-08-09 | 2013-12-25 | 张蕊 | Vitamin K1 injection and preparation method thereof |
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| Title |
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| Solubilizing Excipients in Oral and Injectable Formulations;Robert G. Strickley et al;《Pharmaceutical Research》;20040229;第21卷(第2期);第201-230页 * |
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