CN107213120A - A kind of Diisopropylamine Dichloroacetate freeze-dried powder and preparation method thereof - Google Patents
A kind of Diisopropylamine Dichloroacetate freeze-dried powder and preparation method thereof Download PDFInfo
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- CN107213120A CN107213120A CN201710434147.5A CN201710434147A CN107213120A CN 107213120 A CN107213120 A CN 107213120A CN 201710434147 A CN201710434147 A CN 201710434147A CN 107213120 A CN107213120 A CN 107213120A
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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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
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- 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
- A61K31/13—Amines
- A61K31/131—Amines acyclic
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- 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
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- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
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- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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Abstract
The invention provides a kind of Diisopropylamine Dichloroacetate freeze-dried powder and preparation method thereof, the material composition of following parts by weight is included：2 parts of Diisopropylamine Dichloroacetate, 0.5 2 parts of mannitol, 0.2 1 parts of Lactis Anhydrous, 0.2 0.5 parts of Emprove low endotoxins glycine, 100 120 parts of water for injection；The present invention is using mannitol, Lactis Anhydrous, Emprove low endotoxin glycine collectively as freeze drying protectant; it can make high with liquid stability; obtained freeze-dried powder stability is high; surface is fine and smooth, full loose smooth, good moldability; decoction clarification after being dissolved in water; redissolve rapidly, completely, each qualitative attribute inspection meets quality standard, it is ensured that the security of its clinical application.
Description
Technical field
The present invention relates to field of pharmaceutical preparations, and in particular to a kind of Diisopropylamine Dichloroacetate freeze-dried powder and its system
Preparation Method.
Background technology
Diisopropylamine dichloroacetate, its chemical name is dichloroacetic acid and N- (1- Methylethyls) -2- propanamine compounds (1:
1).The product is the active component of pangamic acid (pangamic acid), shows to promote liver regeneration and anti-grease in non-clinical study
Fat liver acts on.Its mechanism of action for being used clinically for improving liver function may be with suppressing pyruvic dehydrogenase kinase and increase
Liver cell oxygen is absorbed, so that it is relevant to improve the energetic supersession of liver cell etc..It can also improve utilization rate of the brain tissue to oxygen, increase
Plus the CBF of brain, so as to strengthen brain tissue metabolism, increase brain tissue breathes and promotes sugared aerobic glycolysis process.Available for anxious slow
Property hepatitis, fatty liver, hepatic sclerosis, the treatment of jaundice and other liver diseases, it may also be used in point sequelae, cerebral hemorrhage, brain
Softening, arteriosclerosis, hypertension, miocardial infarction, myocarditis and heart are only capable of incomplete caused various obstacles.
Current compound type is mainly the injection that Diisopropylamine Dichloroacetate is made with sodium gluconate or calcium gluconae
Liquid or tablet.Parenteral solution is rapid-action, and effect is strong, be easy to by clinic receiving, but parenteral solution is unfavorable for storage and transport, and freezes
Powder injection formulation can then overcome this shortcoming.But occurred Diisopropylamine Dichloroacetate freeze-dried powder system in the prior art
Agent, its stability stills need to do further raising.
The content of the invention
It is an object of the invention to provide a kind of Diisopropylamine Dichloroacetate freeze-dried powder and preparation method thereof, it is made
Freeze-dried powder stability it is high, surface is fine and smooth, full loose smooth, good moldability, the decoction clarification after being dissolved in water, and redissolves fast
Fast, complete, each qualitative attribute inspection meets quality standard, it is ensured that the security of its clinical application.
To realize object above, the present invention is achieved by the following technical programs：
A kind of Diisopropylamine Dichloroacetate freeze-dried powder, includes the material composition of following parts by weight：Dichloroacetic acid two
2 parts of isopropylamine, 0.5-2 parts of mannitol, 0.2-1 parts of Lactis Anhydrous, 0.2-0.5 parts of Emprove low endotoxin glycine, injection
100-120 parts of water.
Present invention also offers a kind of preparation method of Diisopropylamine Dichloroacetate freeze-dried powder, including following step
Suddenly：
(1) according to above-mentioned formula weigh 2 parts of Diisopropylamine Dichloroacetate, 0.5-2 parts of mannitol, 0.2-1 parts of Lactis Anhydrous,
0.2-0.5 parts of Emprove low endotoxin glycine, adds the 88-92% of water for injection total amount, stirring to dissolving；Adjusted using pH
Save agent and adjust pH value to 4.5-7.5, add water for injection to full dose, it is common 100-120 parts with water, produce decoction after stirring；
(2) add amount of liquid medicine 0.03-0.06% activated carbon stirring 20-40min, filter out after activated carbon, through aseptic filtration,
Filling, half tamponade, freeze-drying, tamponade, Zha Gai, packaging are produced.
Preferably, the pH adjusting agent is pharmaceutically acceptable pH adjusting agent；The pH adjusting agent can for sodium hydroxide,
Potassium hydroxide, sodium dihydrogen phosphate, disodium hydrogen phosphate, potassium dihydrogen phosphate, hydrochloric acid, phosphoric acid or its combination；
Preferably, in the step (1), pH value is adjusted to 5.5-6 using pH adjusting agent.
Preferably, the addition of the activated carbon is the 0.05% of amount of liquid medicine.
Preferably, aseptic filtration is in the step (2)：Successively using 0.45 μm and 0.22 μm of the degerming mistake of miillpore filter
Filter.
Preferably, medicine liquid irrigation is filled in cillin bottle in the step (2), sent into after half tamponade in freeze drier, drop
1.5-2h is kept when temperature is to -20 ± 2 DEG C；- 40 ± 2 DEG C are cooled to, 2-3h is kept；Vacuum pump startup, is evacuated to 20 ± 2Pa；
It is to slowly warm up to -20 ± 2 DEG C and keeps 8-12h；It is to slowly warm up to -5 ± 2 DEG C and keeps 2-3h；35 ± 2 DEG C are to slowly warm up to again
And keep 5-7h.
The beneficial effects of the invention are as follows：
The present invention uses mannitol, Lactis Anhydrous, Emprove low endotoxin glycine collectively as freeze drying protectant, can
Make with liquid stability height, obtained freeze-dried powder stability is high, and surface is fine and smooth, and full loose smooth, good moldability is dissolved in water
Decoction clarification afterwards, redissolves rapidly, completely, each qualitative attribute inspection meets quality standard, it is ensured that the peace of its clinical application
Quan Xing.
The use of organic solvent-free, can reduce the bad shadow to staff and environment when producing freeze-dried powder of the present invention
Ring, and preparation technology is more simple and easy to do, meets workshop large-scale production demand.Adding appropriate activated carbon in process of production has
Help improve the clarity of decoction, and adsorbable thermal source, drainage etc..Rationally set in freezing dry process each phase temperature with
And the retention time, freeze-dried powder outward appearance of the present invention can be made more preferable.
Embodiment
To make the purpose, technical scheme and advantage of the embodiment of the present invention clearer, below in conjunction with the embodiment of the present invention,
Technical scheme in the embodiment of the present invention is clearly and completely described, it is clear that described embodiment is the present invention one
Divide embodiment, rather than whole embodiments.Based on the embodiment in the present invention, those of ordinary skill in the art are not making
The every other embodiment obtained under the premise of creative work, belongs to the scope of protection of the invention.
Embodiment 1：The preparation (1000 bottles) of Diisopropylamine Dichloroacetate freeze-dried powder
1st, prescription：
Diisopropylamine Dichloroacetate 20g, mannitol 15g, Lactis Anhydrous 5g, Emprove low endotoxin glycine 3g, injection
Use water 1000ml.
2nd, preparation method：
Comprise the following steps：
(1) to weigh Diisopropylamine Dichloroacetate 20g, mannitol 15g, Lactis Anhydrous 5g, Emprove according to above-mentioned formula low
Endotoxin glycine 3g, adds the 90% of water for injection total amount, stirring to dissolving；Use phosphoric acid-sodium dihydrogen phosphate buffer
PH value is adjusted to 5.5, water for injection is added to full dose, with the common 1000ml of water, decoction is produced after stirring；
(2) add the activated carbon stirring 30min of amount of liquid medicine 0.05%, filter out after activated carbon, successively using 0.45 μm and
0.22 μm of miillpore filter aseptic filtration, then every bottle of 1ml/ is filling in cillin bottle, then the feeding freeze-drying after half tamponade
In machine, 2h is kept when being cooled to -20 ± 2 DEG C；- 40 ± 2 DEG C are cooled to, 3h is kept；Vacuum pump startup, is evacuated to 20 ± 2Pa；
It is to slowly warm up to -20 ± 2 DEG C and keeps 10h；It is to slowly warm up to -5 ± 2 DEG C and keeps 2h；35 ± 2 DEG C are to slowly warm up to again and are protected
Hold 6h；Most produced afterwards through tamponade, Zha Gai, packaging.
Embodiment 2：The preparation (1200 bottles) of Diisopropylamine Dichloroacetate freeze-dried powder
1st, prescription：
Diisopropylamine Dichloroacetate 20g, mannitol 20g, Lactis Anhydrous 4g, Emprove low endotoxin glycine 4g, injection
Use water 1200ml.
2nd, preparation method：
Comprise the following steps：
(1) to weigh Diisopropylamine Dichloroacetate 20g, mannitol 20g, Lactis Anhydrous 4g, Emprove according to above-mentioned formula low
Endotoxin glycine 4g, adds the 92% of water for injection total amount, stirring to dissolving；PH value is adjusted to 7.5 using NaOH solution, plus
Enter water for injection to full dose, with the common 1200ml of water, decoction is produced after stirring；
(2) add the activated carbon stirring 20min of amount of liquid medicine 0.03%, filter out after activated carbon, successively using 0.45 μm and
0.22 μm of miillpore filter aseptic filtration, then every bottle of 1ml/ is filling in cillin bottle, then the feeding freeze-drying after half tamponade
In machine, 1.5h is kept when being cooled to -20 ± 2 DEG C；- 40 ± 2 DEG C are cooled to, 3h is kept；Vacuum pump startup, it is evacuated to 20 ±
2Pa；It is to slowly warm up to -20 ± 2 DEG C and keeps 10h；It is to slowly warm up to -5 ± 2 DEG C and keeps 3h；35 ± 2 DEG C are to slowly warm up to again
And keep 7h；Most produced afterwards through tamponade, Zha Gai, packaging.
Embodiment 3：The preparation (1000 bottles) of Diisopropylamine Dichloroacetate freeze-dried powder
1st, prescription：
Diisopropylamine Dichloroacetate 20g, mannitol 5g, Lactis Anhydrous 10g, Emprove low endotoxin glycine 5g, injection
Use water 1000ml.
2nd, preparation method：
Comprise the following steps：
(1) to weigh Diisopropylamine Dichloroacetate 20g, mannitol 5g, Lactis Anhydrous 10g, Emprove according to above-mentioned formula low
Endotoxin glycine 5g, adds the 88% of water for injection total amount, stirring to dissolving；Use phosphoric acid-sodium dihydrogen phosphate buffer
PH value is adjusted to 4.5, water for injection is added to full dose, with the common 1000ml of water, decoction is produced after stirring；
(2) add the activated carbon stirring 40min of amount of liquid medicine 0.06%, filter out after activated carbon, successively using 0.45 μm and
0.22 μm of miillpore filter aseptic filtration, then every bottle of 1ml/ is filling in cillin bottle, then the feeding freeze-drying after half tamponade
In machine, 2h is kept when being cooled to -20 ± 2 DEG C；- 40 ± 2 DEG C are cooled to, 2h is kept；Vacuum pump startup, is evacuated to 20 ± 2Pa；
It is to slowly warm up to -20 ± 2 DEG C and keeps 12h；It is to slowly warm up to -5 ± 2 DEG C and keeps 2h；35 ± 2 DEG C are to slowly warm up to again and are protected
Hold 5h；Most produced afterwards through tamponade, Zha Gai, packaging.
Embodiment 4：The preparation (1100 bottles) of Diisopropylamine Dichloroacetate freeze-dried powder
1st, prescription：
Diisopropylamine Dichloroacetate 20g, mannitol 10g, Lactis Anhydrous 8g, Emprove low endotoxin glycine 2g, injection
Use water 1100ml.
2nd, preparation method：
Comprise the following steps：
(1) to weigh Diisopropylamine Dichloroacetate 20g, mannitol 10g, Lactis Anhydrous 8g, Emprove according to above-mentioned formula low
Endotoxin glycine 2g, adds the 90% of water for injection total amount, stirring to dissolving；Using salt acid for adjusting pH value to 5, injection is added
With water to full dose, with the common 1100ml of water, decoction is produced after stirring；
(2) add the activated carbon stirring 30min of amount of liquid medicine 0.04%, filter out after activated carbon, successively using 0.45 μm and
0.22 μm of miillpore filter aseptic filtration, then every bottle of 1ml/ is filling in cillin bottle, then the feeding freeze-drying after half tamponade
In machine, holding -2h when being cooled to -20 ± 2 DEG C；- 40 ± 2 DEG C are cooled to, 2.5h is kept；Vacuum pump startup, it is evacuated to 20 ±
2Pa；It is to slowly warm up to -20 ± 2 DEG C and keeps 8h；It is to slowly warm up to -5 ± 2 DEG C and keeps 3h；35 ± 2 DEG C are to slowly warm up to again
And keep 6h；Most produced afterwards through tamponade, Zha Gai, packaging.
Embodiment 5：The preparation (1200 bottles) of Diisopropylamine Dichloroacetate freeze-dried powder
1st, prescription：
Diisopropylamine Dichloroacetate 20g, mannitol 12g, Lactis Anhydrous 7g, Emprove low endotoxin glycine 3g, injection
Use water 1200ml.
2nd, preparation method：
Comprise the following steps：
(1) to weigh Diisopropylamine Dichloroacetate 20g, mannitol 12g, Lactis Anhydrous 7g, Emprove according to above-mentioned formula low
Endotoxin glycine 3g, adds the 90% of water for injection total amount, stirring to dissolving；Use phosphoric acid-sodium dihydrogen phosphate buffer
PH value is adjusted to 6, water for injection is added to full dose, with the common 1200ml of water, decoction is produced after stirring；
(2) add the activated carbon stirring 30min of amount of liquid medicine 0.05%, filter out after activated carbon, successively using 0.45 μm and
0.22 μm of miillpore filter aseptic filtration, then every bottle of 1ml/ is filling in cillin bottle, then the feeding freeze-drying after half tamponade
In machine, 2h is kept when being cooled to -20 ± 2 DEG C；- 40 ± 2 DEG C are cooled to, 3h is kept；Vacuum pump startup, is evacuated to 20 ± 2Pa；
It is to slowly warm up to -20 ± 2 DEG C and keeps 8h；It is to slowly warm up to -5 ± 2 DEG C and keeps 3h；35 ± 2 DEG C are to slowly warm up to again and are protected
Hold 7h；Most produced afterwards through tamponade, Zha Gai, packaging.
Performance test：
Embodiment 1-3 products obtained therefroms are put and placed 24 months under room temperature condition, its stability, testing result are investigated during this period
As shown in table 1：
The testing result of table 1
Have table 1 understand, the preparation-obtained freeze-dried powder steady qualities of embodiment 1-3, moisture, content, turbidity, can
See that the index of foreign matter is very excellent.
The above embodiments are merely illustrative of the technical solutions of the present invention, rather than its limitations；Although with reference to the foregoing embodiments
The present invention is described in detail, it will be understood by those within the art that：It still can be to foregoing each implementation
Technical scheme described in example is modified, or carries out equivalent substitution to which part technical characteristic；And these modification or
Replace, the essence of appropriate technical solution is departed from the spirit and scope of various embodiments of the present invention technical scheme.
Claims (7)
1. a kind of Diisopropylamine Dichloroacetate freeze-dried powder, it is characterised in that include the material composition of following parts by weight：Two
2 parts of chloroacetic acid diisopropylamine, 0.5-2 parts of mannitol, 0.2-1 parts of Lactis Anhydrous, Emprove low endotoxin glycine 0.2-0.5
Part, 100-120 parts of water for injection.
2. a kind of preparation method of Diisopropylamine Dichloroacetate freeze-dried powder as claimed in claim 1, it is characterised in that：
Comprise the following steps：
(1) according to above-mentioned formula weigh 2 parts of Diisopropylamine Dichloroacetate, 0.5-2 parts of mannitol, 0.2-1 parts of Lactis Anhydrous,
0.2-0.5 parts of Emprove low endotoxin glycine, adds the 88-92% of water for injection total amount, stirring to dissolving；Adjusted using pH
Save agent and adjust pH value to 4.5-7.5, add water for injection to full dose, it is common 100-120 parts with water, produce decoction after stirring；
(2) amount of liquid medicine 0.03-0.06% activated carbon stirring 20-40min is added, filters out after activated carbon, through aseptic filtration, fills
Dress, half tamponade, freeze-drying, tamponade, Zha Gai, packaging are produced.
3. the preparation method of Diisopropylamine Dichloroacetate freeze-dried powder as claimed in claim 2, it is characterised in that：It is described
PH adjusting agent is pharmaceutically acceptable pH adjusting agent.
4. the preparation method of Diisopropylamine Dichloroacetate freeze-dried powder as claimed in claim 2, it is characterised in that：It is described
In step (1), pH value is adjusted to 5.5-6 using pH adjusting agent.
5. the preparation method of Diisopropylamine Dichloroacetate freeze-dried powder as claimed in claim 2, it is characterised in that：It is described
The addition of activated carbon is the 0.05% of amount of liquid medicine.
6. the preparation method of Diisopropylamine Dichloroacetate freeze-dried powder as claimed in claim 2, it is characterised in that：It is described
Aseptic filtration is in step (2)：Successively using 0.45 μm and 0.22 μm of miillpore filter aseptic filtration.
7. the preparation method of Diisopropylamine Dichloroacetate freeze-dried powder as claimed in claim 2, it is characterised in that：It is described
Medicine liquid irrigation is filled in cillin bottle by step in (2), is sent into freeze drier, is kept when being cooled to -20 ± 2 DEG C after half tamponade
1.5-2h；- 40 ± 2 DEG C are cooled to, 2-3h is kept；Vacuum pump startup, is evacuated to 20 ± 2Pa；It is to slowly warm up to -20 ± 2 DEG C
And keep 8-12h；It is to slowly warm up to -5 ± 2 DEG C and keeps 2-3h；35 ± 2 DEG C are to slowly warm up to again and keep 5-7h.
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| CN201710434147.5A CN107213120A (en) | 2017-06-09 | 2017-06-09 | A kind of Diisopropylamine Dichloroacetate freeze-dried powder and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201710434147.5A CN107213120A (en) | 2017-06-09 | 2017-06-09 | A kind of Diisopropylamine Dichloroacetate freeze-dried powder and preparation method thereof |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1557289A (en) * | 2004-02-04 | 2004-12-29 | 天津市资福医药科技开发有限公司 | Tensicor freeze-drying formulation and its making method |
| CN1568956A (en) * | 2004-04-28 | 2005-01-26 | 肖广常 | Compound diisopropylamine dichloroacetate powder and injection prreparations |
| CN1628650A (en) * | 2003-12-19 | 2005-06-22 | 刘力 | Compound diisopropylamine dichloroacetate freeze dried injection and preparation method thereof |
-
2017
- 2017-06-09 CN CN201710434147.5A patent/CN107213120A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1628650A (en) * | 2003-12-19 | 2005-06-22 | 刘力 | Compound diisopropylamine dichloroacetate freeze dried injection and preparation method thereof |
| CN1557289A (en) * | 2004-02-04 | 2004-12-29 | 天津市资福医药科技开发有限公司 | Tensicor freeze-drying formulation and its making method |
| CN1568956A (en) * | 2004-04-28 | 2005-01-26 | 肖广常 | Compound diisopropylamine dichloroacetate powder and injection prreparations |
Non-Patent Citations (1)
| Title |
|---|
| 刘继馨等: "不同冻干保护剂对利巴韦林冻干粉针的影响研究", 《现代药物与临床》 * |
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Application publication date: 20170929 |