CN106109423A - A kind of injection Vistamycin lyophilized injectable powder and preparation method thereof - Google Patents
A kind of injection Vistamycin lyophilized injectable powder and preparation method thereof Download PDFInfo
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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
- A61K9/0012—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
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- A—HUMAN NECESSITIES
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7028—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
- A61K31/7034—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin
- A61K31/7036—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin having at least one amino group directly attached to the carbocyclic ring, e.g. streptomycin, gentamycin, amikacin, validamycin, fortimicins
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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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Abstract
This application discloses a kind of injection Vistamycin lyophilized injectable powder, including: Vistamycin 1000g；Water for injection 2000mL；Its preparation method comprises the steps: that (1) prepares Vistamycin semi-finished product；(2) Vistamycin semi-finished product are carried out lyophilization, described lyophilization includes following three stages: in the pre-freeze stage: first freeze dryer flaggy temperature is down to 0 DEG C, puts in freeze dryer by Vistamycin semi-finished product, keep 30 minutes, it is down to 40 DEG C again, keeps 2 hours；The sublimation drying stage: flaggy temperature is warming up to 5 DEG C～0 DEG C, and keeps 2 hours；The parsing-desiccation stage: flaggy temperature is warming up to 35 DEG C, and keep 3 hours, obtain Vistamycin lyophilized injectable powder.The advantages such as it is high that the Vistamycin of the application has yield rate, and solubility is good, and quality is more stable, whole lyophilizing technique is the shortest, substantially reduces production cost.
Description
Technical field
The application belongs to medicine and medicine manufacture technology field, more particularly, it relates to a kind of injection sulphuric acid ribose is mould
Freezing-dried powder agent and preparation method thereof.
Background technology
Vistamycin is a kind of aminoglycoside antibiotics, and antimicrobial spectrum is similar to kanamycin, and that is mould compared with card for toxicity
Element is low.Vistamycin is mainly combined with bacterial ribosome 30S subunit, suppresses antibacterial synthetic protein.It is used for clinically
Respiratory tract, abdominal cavity, thoracic cavity, urinary tract, skin and soft tissue, osseous tissue and eye, ear nose caused by sensitive gram negative bacilli
Portion infects.
The enterobacteriaceae lactobacteriaceaes such as escherichia coli, Klebsiella, Proteus are had the most anti-by Vistamycin
Bacterium activity, has faint effect to mycobacterium tuberculosis and Streptococcus, to Pseudomonas aeruginosa and anaerobe without effect.Antibacterial pair
Vistamycin and kanamycin have cross resistance.In clinic Vistamycin single be administered time narrow antimicrobial spectrum, easily go out
Existing bacterial resistance situation, and when Vistamycin and low molecular weight dextran administering drug combinations, increased the weight of the infringement to kidney.
Summary of the invention
An aspect according to the application, it is provided that a kind of injection Vistamycin composite freeze-dried powder agent.
To achieve these goals, the application adopts the following technical scheme that
A kind of injection Vistamycin lyophilized injectable powder, it is characterised in that described injection Vistamycin freezes
Dry powder injection includes:
Vistamycin 1000 weight portion；
With water for injection, Vistamycin is dissolved to 400～600g/L；
Its preparation method comprises the steps:
(1) Vistamycin semi-finished product are prepared；
(2) Vistamycin semi-finished product carrying out lyophilization, described lyophilization includes following three stages:
The pre-freeze stage: first freeze dryer flaggy temperature is down to-4 DEG C～4 DEG C, Vistamycin semi-finished product are put into lyophilizing
In machine, keep 20～40 minutes, then be down to-45 DEG C～-35 DEG C, keep 1～3 hour；
The sublimation drying stage: flaggy temperature is warming up to-5 DEG C～0 DEG C, and keeps 1～3 hour；
The parsing-desiccation stage: flaggy temperature is warming up to 30～40 DEG C, and keep 2～4 hours, obtain Vistamycin and freeze
Dry powder injection；
Preferably described lyophilization includes following three stages:
The pre-freeze stage: first freeze dryer flaggy temperature is down to 0 DEG C, Vistamycin semi-finished product are put in freeze dryer,
Keep 30 minutes, then to be down to-40 DEG C, keep 2 hours；
The sublimation drying stage: flaggy temperature is warming up to-5 DEG C～0 DEG C, and keeps 2 hours；
The parsing-desiccation stage: flaggy temperature is warming up to 35 DEG C, and keep 3 hours, obtain Vistamycin freeze-dried powder
Agent.
A kind of injection Vistamycin lyophilized injectable powder, it is characterised in that described injection Vistamycin freezes
Dry powder injection includes:
Vistamycin 1000 weight portion；
With water for injection, Vistamycin is dissolved to 800-1200g/L, preferably 1000g/L；Its preparation method bag
Include following steps:
(1) Vistamycin semi-finished product are prepared；
(2) Vistamycin semi-finished product carrying out lyophilization, described lyophilization includes following three stages:
The pre-freeze stage: first freeze dryer flaggy temperature is down to-4 DEG C～4 DEG C, Vistamycin semi-finished product are put into lyophilizing
In machine, keep 20～40 minutes, then be down to-45 DEG C～-35 DEG C, keep 1～3 hour；
The sublimation drying stage: flaggy temperature is warming up to-5 DEG C～0 DEG C, and keeps 1～3 hour；
The parsing-desiccation stage: flaggy temperature is warming up to 30～40 DEG C, and keep 2～4 hours, obtain Vistamycin and freeze
Dry powder injection；
Preferably described lyophilization includes following three stages:
The pre-freeze stage: first freeze dryer flaggy temperature is down to 0 DEG C, Vistamycin semi-finished product are put in freeze dryer,
Keep 30 minutes, then to be down to-40 DEG C, keep 2 hours；
The sublimation drying stage: flaggy temperature is warming up to-5 DEG C～0 DEG C, and keeps 2 hours；
The parsing-desiccation stage: flaggy temperature is warming up to 35 DEG C, and keep 3 hours, obtain Vistamycin freeze-dried powder
Agent.
Another aspect according to the application, it is provided that the preparation side of a kind of injection Vistamycin lyophilized injectable powder
Method.
The preparation method of a kind of Vistamycin lyophilized injectable powder, it is characterised in that described method comprises the steps:
(1) Vistamycin semi-finished product are prepared；
(2) Vistamycin semi-finished product carrying out lyophilization, described lyophilization includes following three stages:
The pre-freeze stage: first freeze dryer flaggy temperature is down to-4 DEG C～4 DEG C, Vistamycin semi-finished product are put into lyophilizing
In machine, keep 20～40 minutes, then be down to-45 DEG C～-35 DEG C, keep 1～3 hour；
The sublimation drying stage: flaggy temperature is warming up to-5 DEG C～0 DEG C, and keeps 1～3 hour；
The parsing-desiccation stage: flaggy temperature is warming up to 30～40 DEG C, and keep 2～4 hours, obtain Vistamycin and freeze
Dry powder injection；
Preferably described lyophilization includes following three stages:
The pre-freeze stage: first freeze dryer flaggy temperature is down to 0 DEG C, Vistamycin semi-finished product are put in freeze dryer,
Keep 30 minutes, then to be down to-40 DEG C, keep 2 hours；
The sublimation drying stage: flaggy temperature is warming up to-5 DEG C～0 DEG C, and keeps 2 hours；
The parsing-desiccation stage: flaggy temperature is warming up to 35 DEG C, and keep 3 hours, obtain Vistamycin freeze-dried powder
Agent.
Preferably, when step (2) carries out lyophilizing, when the sublimation drying stage, with constant rate of speed 4 DEG C/h be warming up to-
5 DEG C～0 DEG C.
Preferably, when step (2) carries out lyophilizing, when the parsing-desiccation stage, it is warming up to constant rate of speed 8 DEG C/h
30-40℃。
Preferably, when step (2) carries out lyophilizing, when the pre-freeze stage, it is cooled to-45 DEG C～-35 DEG C from-4 DEG C～4 DEG C
Time be 1-2.5 hour.
Preferably, step (1) specifically includes:
Accurately weighing the Vistamycin of recipe quantity, be added into the water for injection of recipe quantity, stirring and dissolving is extremely
Solution is clarified；Counting activated carbon again and be stirred absorption, remove activated carbon, through filtering with microporous membrane, obtained filtrate is
Vistamycin semi-finished product.
Preferably, the consumption of activated carbon is 0.1%g/mL.It is to say, the consumption of activated carbon is to add in every 100mL solution
Enter 0.1g activated carbon.
Preferably, herein described refer to respectively through the microporous filter membrane mistake of 0.45 μm and 0.22 μm through filtering with microporous membrane
Filter.
Preferably, the time of activated carbon stirring and adsorbing is 20-40 minute.
The beneficial effect that the application can produce includes:
(1) Vistamycin lyophilized injectable powder provided herein is without while any excipient, it is ensured that good
Good lyophilizing outward appearance, medication is safer.
(2) the Vistamycin lyophilized injectable powder of the application uses the pre-freeze mode of segmentation so that product rate of temperature fall
Faster, the crystallization particle diameter of formation is less and homogeneous, and after lyophilizing, outward appearance is loose uniformly, solubility is more preferable.
(3) outward appearance of Vistamycin lyophilized injectable powder, solubility, content provided herein and have related substance to examine
Examining result of the test to understand, compared with prior art, it is high that the Vistamycin of the application has yield rate, and solubility is good, quality
The advantage such as more stable, whole lyophilizing technique is the shortest, substantially reduces production cost.
Detailed description of the invention
Below in conjunction with embodiment in detail the application is described in detail, but the application is not limited to these embodiments.
If no special instructions, the raw material in embodiments herein is all bought by commercial sources, shown in table specific as follows:
| Title | Effect | Manufacturer | Authentication code | Quality standard |
| Vistamycin | Raw material | Wuxi Fu Qi pharmaceutical Co. Ltd | Traditional Chinese medicines quasi-word H32020841 | Chinese Pharmacopoeia |
Embodiment 1
A kind of injection Vistamycin lyophilized injectable powder, including:
Vistamycin 1000g；
With 2000mL water for injection, Vistamycin is dissolved to 500g/L；
Its preparation method comprises the steps:
(1) Vistamycin semi-finished product are prepared: accurately weigh the Vistamycin of recipe quantity, be added into prescription
In the water for injection of amount, stirring and dissolving to solution is clarified；Counting activated carbon again and be stirred absorption, the time is 30 minutes, activity
The consumption of charcoal is 0.1%g/mL；Removing activated carbon, through 0.45 μm and the filtering with microporous membrane of 0.22 μm, obtained filtrate is i.e.
For Vistamycin semi-finished product.
(2) Vistamycin semi-finished product carrying out lyophilization, described lyophilization includes following three stages:
The pre-freeze stage: first freeze dryer flaggy temperature is down to 0 DEG C, Vistamycin semi-finished product are put in freeze dryer,
Keep 30 minutes, then be down to-40 DEG C through 1 hour, keep 2 hours；
The sublimation drying stage: flaggy temperature to-5 DEG C～0 DEG C, and keeps 3 hours with the heating rate of 4 DEG C/h；
The parsing-desiccation stage: flaggy temperature, and keeps 3 hours to 35 DEG C with the heating rate of 8 DEG C/h, obtains sulphuric acid
Ribostamycin lyophilized injectable powder.
Embodiment 2
A kind of injection Vistamycin lyophilized injectable powder, including:
Vistamycin 1000g；
With 1000mL water for injection, Vistamycin is dissolved to 1000g/L；
Its preparation method comprises the steps:
(1) Vistamycin semi-finished product are prepared: accurately weigh the Vistamycin of recipe quantity, be added into prescription
In the water for injection of amount, stirring and dissolving to solution is clarified；Counting activated carbon again and be stirred absorption, the time is 40 minutes, activity
The consumption of charcoal is 0.1%g/mL；Removing activated carbon, through 0.45 μm and the filtering with microporous membrane of 0.22 μm, obtained filtrate is i.e.
For Vistamycin semi-finished product.
(2) Vistamycin semi-finished product carrying out lyophilization, described lyophilization includes following three stages:
The pre-freeze stage: first freeze dryer flaggy temperature is down to 0 DEG C, Vistamycin semi-finished product are put in freeze dryer,
Keep 40 minutes, then be down to-45 DEG C through 2.5 hours, keep 1 hour；
The sublimation drying stage: flaggy temperature to-5 DEG C～0 DEG C, and keeps 2 hours with the heating rate of 4 DEG C/h；
The parsing-desiccation stage: flaggy temperature, and keeps 2 hours to 40 DEG C with the heating rate of 8 DEG C/h, obtains sulphuric acid
Ribostamycin lyophilized injectable powder.
Embodiment 3
A kind of injection Vistamycin lyophilized injectable powder, including:
Vistamycin 1000g；
With 2500mL water for injection, Vistamycin is dissolved to 400g/L；
Its preparation method comprises the steps:
(1) Vistamycin semi-finished product are prepared: accurately weigh the Vistamycin of recipe quantity, be added into prescription
In the water for injection of amount, stirring and dissolving to solution is clarified；Counting activated carbon again and be stirred absorption, the time is 20 minutes, activity
The consumption of charcoal is 0.1%g/mL；Removing activated carbon, through 0.45 μm and the filtering with microporous membrane of 0.22 μm, obtained filtrate is i.e.
For Vistamycin semi-finished product.
(2) Vistamycin semi-finished product carrying out lyophilization, described lyophilization includes following three stages:
The pre-freeze stage: first freeze dryer flaggy temperature is down to-4 DEG C, Vistamycin semi-finished product are put in freeze dryer,
Keep 20 minutes, then be down to-35 DEG C through 1.5 hours, keep 3 hours；
The sublimation drying stage: flaggy temperature to-5 DEG C～0 DEG C, and keeps 1 hour with the heating rate of 4 DEG C/h；
The parsing-desiccation stage: flaggy temperature, and keeps 4 hours to 30 DEG C with the heating rate of 8 DEG C/h, obtains sulphuric acid
Ribostamycin lyophilized injectable powder.
Embodiment 3
The present embodiment relates to the application Vistamycin lyophilized injectable powder outward appearance, solubility, content, has related substance to investigate
Test.
Investigate group: prepare Vistamycin freeze-dried powder according to the preparation method of Example 1 and Example 2 of the present invention
Agent；Embodiment 1 in patent application 201310481684.7 is used to prepare Vistamycin lyophilized injectable powder；
Inspection target: the outward appearance of product, solubility, content and have related substance.
Investigation method: content, relevant substance detecting method are Same Way, all uses the high-efficient liquid of 2010 editions States Pharmacopoeia specifications
Phase chromatography measures.
Investigate result and see shown in following table:
As can be seen from the above table, the redissolution speed of Vistamycin lyophilized injectable powder provided herein is fine, clear
Spend clearly, it is seen that foreign body meets regulation.
By the Vistamycin lyophilized injectable powder in the embodiment of the present application 1 and embodiment 2 and patent application
201310481684.7 lyophilized injectable powders are accelerated test, through accelerated test, i.e. investigate (40 DEG C under acceleration conditions of sample
± 2 DEG C, RH75% ± 5%) detected after 6 months, testing result is as follows:
As seen from the above table, investigating through the accelerated tests of 6 months, injection Vistamycin provided herein freezes
Dry powder injection sample indices is all without notable change.
The above, be only several embodiments of the application, the application not does any type of restriction, although this Shen
Please with preferred embodiment disclose as above, but and be not used to limit the application, any those skilled in the art, do not taking off
In the range of technical scheme, utilize the technology contents of the disclosure above to make a little variation or modification is all equal to
Effect case study on implementation, in the range of belonging to technical scheme.
Claims (10)
1. an injection Vistamycin lyophilized injectable powder, it is characterised in that described injection Vistamycin lyophilizing
Injectable powder includes:
Vistamycin 1000 weight portion；
With water for injection, Vistamycin is dissolved to 400～600g/L；
Its preparation method comprises the steps:
(1) Vistamycin semi-finished product are prepared；
(2) Vistamycin semi-finished product carrying out lyophilization, described lyophilization includes following three stages:
The pre-freeze stage: first freeze dryer flaggy temperature is down to-4 DEG C～4 DEG C, Vistamycin semi-finished product are put into freeze dryer
In, keep 20～40 minutes, then be down to-45 DEG C～-35 DEG C, keep 1～3 hour；
The sublimation drying stage: flaggy temperature is warming up to-5 DEG C～0 DEG C, and keeps 1～3 hour；
The parsing-desiccation stage: flaggy temperature is warming up to 30～40 DEG C, and keep 2～4 hours, obtain Vistamycin lyophilized powder
Injection；
The most described lyophilization includes the three below stage:
In the pre-freeze stage: first freeze dryer flaggy temperature is down to 0 DEG C, Vistamycin semi-finished product are put in freeze dryer, keep
30 minutes, then it is down to-40 DEG C, keep 2 hours；
The sublimation drying stage: flaggy temperature is warming up to-5 DEG C～0 DEG C, and keeps 2 hours；
The parsing-desiccation stage: flaggy temperature is warming up to 35 DEG C, and keep 3 hours, obtain Vistamycin lyophilized injectable powder.
2. an injection Vistamycin lyophilized injectable powder, it is characterised in that described injection Vistamycin lyophilizing
Injectable powder includes:
Vistamycin 1000 weight portion；
With water for injection, Vistamycin is dissolved to 800-1200g/L, preferably 1000g/L；Its preparation method include as
Lower step:
(1) Vistamycin semi-finished product are prepared；
(2) Vistamycin semi-finished product carrying out lyophilization, described lyophilization includes following three stages:
The pre-freeze stage: first freeze dryer flaggy temperature is down to-4 DEG C～4 DEG C, Vistamycin semi-finished product are put into freeze dryer
In, keep 20～40 minutes, then be down to-45 DEG C～-35 DEG C, keep 1～3 hour；
The sublimation drying stage: flaggy temperature is warming up to-5 DEG C～0 DEG C, and keeps 1～3 hour；
The parsing-desiccation stage: flaggy temperature is warming up to 30～40 DEG C, and keep 2～4 hours, obtain Vistamycin lyophilized powder
Injection；
The most described lyophilization includes following three stages:
In the pre-freeze stage: first freeze dryer flaggy temperature is down to 0 DEG C, Vistamycin semi-finished product are put in freeze dryer, keep
30 minutes, then it is down to-40 DEG C, keep 2 hours；
The sublimation drying stage: flaggy temperature is warming up to-5 DEG C～0 DEG C, and keeps 2 hours；
The parsing-desiccation stage: flaggy temperature is warming up to 35 DEG C, and keep 3 hours, obtain Vistamycin lyophilized injectable powder.
3. the preparation method of a Vistamycin lyophilized injectable powder as claimed in claim 1 or 2, it is characterised in that institute
The method of stating comprises the steps:
(1) Vistamycin semi-finished product are prepared；
(2) Vistamycin semi-finished product carrying out lyophilization, described lyophilization includes following three stages:
The pre-freeze stage: first freeze dryer flaggy temperature is down to-4 DEG C～4 DEG C, Vistamycin semi-finished product are put into freeze dryer
In, keep 20～40 minutes, then be down to-45 DEG C～-35 DEG C, keep 1～3 hour；
The sublimation drying stage: flaggy temperature is warming up to-5 DEG C～0 DEG C, and keeps 1～3 hour；
The parsing-desiccation stage: flaggy temperature is warming up to 30～40 DEG C, and keep 2～4 hours, obtain Vistamycin lyophilized powder
Injection；
The most described lyophilization includes following three stages:
In the pre-freeze stage: first freeze dryer flaggy temperature is down to 0 DEG C, Vistamycin semi-finished product are put in freeze dryer, keep
30 minutes, then it is down to-40 DEG C, keep 2 hours；
The sublimation drying stage: flaggy temperature is warming up to-5 DEG C～0 DEG C, and keeps 2 hours；
The parsing-desiccation stage: flaggy temperature is warming up to 35 DEG C, and keep 3 hours, obtain Vistamycin lyophilized injectable powder.
The preparation method of Vistamycin lyophilized injectable powder the most according to claim 3, it is characterised in that step (2)
In when carrying out lyophilizing, when the sublimation drying stage, be warming up to-5 DEG C～0 DEG C with constant rate of speed 4 DEG C/h.
The preparation method of Vistamycin lyophilized injectable powder the most according to claim 3, it is characterised in that step (2)
In when carrying out lyophilizing, when the parsing-desiccation stage, be warming up to 30-40 DEG C with constant rate of speed 8 DEG C/h, preferably 35 DEG C.
The preparation method of Vistamycin lyophilized injectable powder the most according to claim 3, it is characterised in that step (2)
In when carrying out lyophilizing, when the pre-freeze stage, be 1-2.5 hour from-4 DEG C～the 4 DEG C times being cooled to-45 DEG C～-35 DEG C.
7. according to the preparation method of the Vistamycin lyophilized injectable powder described in any one in claim 3-5, its feature
Being, step (1) specifically includes:
Accurately weighing the Vistamycin of recipe quantity, be added into the water for injection of recipe quantity, stirring and dissolving is to solution
Clarification；Adding activated carbon and be stirred absorption, remove activated carbon, through filtering with microporous membrane, obtained filtrate is sulphuric acid
Ribostamycin semi-finished product.
The preparation method of Vistamycin lyophilized injectable powder the most according to claim 7, it is characterised in that activated carbon
Consumption is 0.1%g/mL.
9. according to the preparation method of the Vistamycin lyophilized injectable powder described in claim 7 or 8, it is characterised in that through micro-
Hole membrane filtration refers to respectively through 0.45 μm and the filtering with microporous membrane of 0.22 μm.
10. according to the preparation method of the Vistamycin lyophilized injectable powder described in claim 7 or 8, it is characterised in that activity
The time of charcoal stirring and adsorbing is 20-40 minute.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610550776.XA CN106109423A (en) | 2016-07-13 | 2016-07-13 | A kind of injection Vistamycin lyophilized injectable powder and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610550776.XA CN106109423A (en) | 2016-07-13 | 2016-07-13 | A kind of injection Vistamycin lyophilized injectable powder and preparation method thereof |
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102038651A (en) * | 2010-12-25 | 2011-05-04 | 山东新时代药业有限公司 | Ropivacaine mesylate freeze-dried powder injection |
| CN103536554A (en) * | 2013-10-15 | 2014-01-29 | 海南卫康制药(潜山)有限公司 | Ribostamycin sulfate composition freeze-dried powder for injection |
-
2016
- 2016-07-13 CN CN201610550776.XA patent/CN106109423A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102038651A (en) * | 2010-12-25 | 2011-05-04 | 山东新时代药业有限公司 | Ropivacaine mesylate freeze-dried powder injection |
| CN103536554A (en) * | 2013-10-15 | 2014-01-29 | 海南卫康制药(潜山)有限公司 | Ribostamycin sulfate composition freeze-dried powder for injection |
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Application publication date: 20161116 |