CN108042564A - A kind of sodium selenite vitamin C parenteral solutions and its manufacturing method - Google Patents
A kind of sodium selenite vitamin C parenteral solutions and its manufacturing method Download PDFInfo
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- CN108042564A CN108042564A CN201711348788.5A CN201711348788A CN108042564A CN 108042564 A CN108042564 A CN 108042564A CN 201711348788 A CN201711348788 A CN 201711348788A CN 108042564 A CN108042564 A CN 108042564A
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- Prior art keywords
- vitamin
- water
- injection
- sodium selenite
- minutes
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/04—Sulfur, selenium or tellurium; Compounds thereof
-
- 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
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/365—Lactones
- A61K31/375—Ascorbic acid, i.e. vitamin C; Salts thereof
-
- 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
-
- 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
Abstract
The invention discloses a kind of sodium selenite vitamin C parenteral solutions, including raw material and auxiliary material, it is characterised in that：The raw material includes sodium selenite and vitamin C, wherein by weight, using sodium selenite 1g, vitamin C 50g；The auxiliary material includes ethyl alcohol, polyoxyethylene sorbitan monoleate and water for injection, wherein by weight, using ethyl alcohol 50ml, polyoxyethylene sorbitan monoleate 100ml and water for injection 1000ml, the present invention uses a kind of sodium selenite vitamin C parenteral solutions and its manufacturing method for the features such as a kind of production efficiency is high, can simultaneously domestic animals be carried out with selenium-supply and vitamin C, easy to use.
Description
Technical field
The present invention relates to veterinary drug production fields, and in particular to a kind of sodium selenite vitamin C parenteral solutions and its manufacturing method.
Background technology
With the fast development of social economy and the progress of science and technology, domestic animals are either domestic or wild when sick,
It can be played under the treatment of veterinary drug and treat restitution well, domestic animals are in growth course, it is necessary to which selenium-supply and vitamin C, are used
In preventing vitamin C and selenium deficiency is barrenness caused, cub white muscle disease and chick exudative diathesis etc., in actual use process
In, it is inconvenient that domestic animals selenium-supply and vitamin C etc. are generated respectively, and existing sodium selenite vitamin C drugs are in production process work
Skill is more complicated, and production difficulty is big, it is therefore desirable to which a kind of new scheme solves.
The content of the invention
In order to overcome above-mentioned middle the shortcomings of the prior art, the present invention using a kind of production efficiency it is high, can be simultaneously to poultry
Class carries out selenium-supply and vitamin C, it is easy to use the features such as a kind of sodium selenite vitamin C parenteral solutions and its manufacturing method.
The purpose of the present invention is what is realized by following scheme：A kind of sodium selenite vitamin C parenteral solutions, including raw material and
Auxiliary material, it is characterised in that：The raw material includes sodium selenite and vitamin C, wherein by weight, using sodium selenite 1g,
Vitamin C 50g；The auxiliary material includes ethyl alcohol, Tween-80 and water for injection, wherein by weight, using ethyl alcohol
50ml, Tween-80 100ml and water for injection 1000ml.
A kind of sodium selenite vitamin C parenteral solution manufacturing methods, which is characterized in that its manufacturing method includes：
1) the middle water for injection for injecting 300ml in dense preparing tank, is passed through CO2Be allowed to and；
2) feeding port is closed after adding in sodium selenite 1g after previous step, is stirred 15 minutes at 60 DEG C, makes it completely molten
Solution；
3) vitamin C 50g is added after previous step, treats that CO does not occur for liquid level2Steep, add in ethyl alcohol 50ml and
Tween-80 100ml solution stops stirring；
4) it is 5.0~7.0 that pH value is treated after previous step, closes feeding port, and continuing stirring makes it for 5 minutes uniformly；
5) liquid obtained after previous step after stud filter circulation filters 15 minutes into dilute preparing tank, liquid into
After entering dilute preparing tank, after the water for injection of injection amount of preparation 100ml rinses in dense preparing tank, wash water is sent to dilute preparing tank in dense preparing tank；
6) add water for injection 600ml amount of preparation again in dilute preparing tank after previous step, stir 10 minutes, after uniform, by
Refined filtration pump circulation is filtered for 15 minutes, and sodium selenite vitamin C parenteral solutions are obtained after filtering.
The present invention has the beneficial effect that：Production process is simple, and production efficiency is high, it is at low cost the characteristics of raw material it is inexpensively easy
, and gained parenteral solution performance is stablized, and meets pharmacopeia relevant regulations, is suitble to industrialization large-scale production, therefore its application prospect
It is very wide.
Specific embodiment
A kind of sodium selenite vitamin C parenteral solutions, including raw material and auxiliary material, it is characterised in that：The raw material includes Asia
Sodium selenate and vitamin C, wherein by weight, using sodium selenite 1g, vitamin C 50g；The auxiliary material includes ethyl alcohol, gathers
Sorb ester -80 and water for injection, wherein by weight, using ethyl alcohol 50ml, Tween-80 100ml and water for injection
1000ml。
A kind of sodium selenite vitamin C parenteral solution manufacturing methods, which is characterized in that its manufacturing method includes：
1) the middle water for injection for injecting 300ml in dense preparing tank, is passed through CO2Be allowed to and；
2) feeding port is closed after adding in sodium selenite 1g after previous step, is stirred 15 minutes at 60 DEG C, makes it completely molten
Solution；
3) vitamin C 50g is added after previous step, treats that CO does not occur for liquid level2Steep, add in ethyl alcohol 50ml and
Tween-80 100ml solution stops stirring；
4) it is 5.0~7.0 that pH value is treated after previous step, closes feeding port, and continuing stirring makes it for 5 minutes uniformly；
5) liquid obtained after previous step after stud filter circulation filters 15 minutes into dilute preparing tank, liquid into
After entering dilute preparing tank, after the water for injection of injection amount of preparation 100ml rinses in dense preparing tank, wash water is sent to dilute preparing tank in dense preparing tank；
6) add water for injection 600ml amount of preparation again in dilute preparing tank after previous step, stir 10 minutes, after uniform, by
Refined filtration pump circulation is filtered for 15 minutes, and sodium selenite vitamin C parenteral solutions are obtained after filtering.
Embodiment
A kind of sodium selenite vitamin C parenteral solutions so manufacture, this technological process of production includes 8 processes altogether, respectively
The primary operational of a process is as follows：
Process 1：The reason bottle of ampoule bottle is slightly washed
(1) personnel are by providing into reasonable bottle, slightly wash post, and inspection is cleared out a gathering place situation and equipment state, after qualified, resonable bottle room,
Ampoule is fitly emitted in stainless steel pallet, dirty bottle, rotten bottle, thickness is uneven, the inconsistent timely detection of height, reason
Good ampoule is passed to wash bottle room, injects purified water → hydro-extracting cage water dumping → water injection machine injects purified water → by ampoule → water injection machine and gets rid of
Water dispenser water dumping order is operated, and slightly washed ampoule then is passed to fine purifiation room.
(2) key process parameter：
Wash bottle sampling check for quality：50 are taken, egagropilus≤2%
(3) control among：
Purified water visible foreign matters inspection：Fine visible foreign matters (staple fiber and block of such as pointing object, below 2mm) are no
Must have, hence it is evident that visible foreign matters (color dot, foreign matter) must not promising qualification；
Bottle organizing process apoplexy involving the solid organs bottle, rotten bottle, thickness are uneven, the inconsistent timely detection of height；
During wash bottle, water dumping, the clarity of ampoule is checked in time, underproof ampoule is detected.
Process 2：The fine purifiation of ampoule bottle, drying
(1) personnel check clear out a gathering place situation and equipment state, after qualified, from pass-through box by regulation into fine purifiation, drying post
Interior ampoule of the taking-up through slightly washing, ampoule is put on ampoule washing machine, by ampoule → injection water for injection → water dumping → far infrared
Threaded list road sterilizing oven is operated, and after bottle is sent into oven for drying, is passed to cooling chamber, and neatly packed for use.
(2) key process parameter：
Far infrared hot air cycles baking oven：Controlled at 180 DEG C ± 5 DEG C；When constant temperature time is 1.5 small；
Ampoule after sterilizing：Cool down 40-50 DEG C of output it is spare, under clean state store must not exceed 48 it is small when, otherwise
It must fine purifiation, sterilizing again.
(3) control among：
Water for injection visible foreign matters inspection：Fine visible foreign matters (staple fiber and block of such as pointing object, below 2mm)
Must not have, hence it is evident that visible foreign matters (color dot, foreign matter) must not promising qualification；
Detergent bottle visible foreign matters inspection：Take detergent bottle 10, inject water for injection, detected under lamp inspection instrument, containing it is fine can
See that foreign matter (staple fiber and block of such as pointing object, below 2mm) sum must not exceed 1, hence it is evident that visible foreign matters (color dot,
Foreign matter) it must not promising qualification.
Process 3：Dispensing
(1) personnel by regulation into dispensing post, clear out a gathering place situation and equipment state by inspection, by instrument, utensil, liquor piping,
Agitation Tank etc. is rinsed well with water for injection.
Agitation Tank, filter sterilised processing：According to product dispensing needs, sterilize to the Agitation Tank and filter used
Agitation Tank and filter are connected into the circuit of closure by processing with pure steam pipeline, and being passed through steam makes temperature in Agitation Tank and pipeline
Degree rises to set point of temperature, maintains the stipulated time, completes sterilizing, and Agitation Tank includes dense preparing tank and dilute preparing tank etc..
Ingredients personnel checks the name of an article of supplementary material, quantity, manufacturer, product batch number, eligible state etc., then takes off bag and passes
It is handed in weighing, double review is weighed the material of recipe quantity.
Enter the water for injection of about 300ml in dense preparing tank, be passed through CO2Saturation is allowed to, is closed after adding in sodium selenite 1g
Feeding port stirs 15 minutes at 60 DEG C, is completely dissolved it, then it is slowly a small amount of repeatedly add in vitamin C 50g, in order to avoid reaction
Liquid acutely is spilt, treats that CO does not occur for liquid level2During bubble, ethyl alcohol 50ml and Tween-80 100ml solution are added in, is stopped
Stirring, it is 5.0~7.0 to treat pH value；Feeding port is turned off, continuing stirring makes it for 5 minutes uniformly；Concentrated wiring liquid is followed through stud filter
Ring filters 15 minutes, take a sample to check liquid pH value and character, and after qualified, closing volume pipeline valve is opened into dilute preparing tank pipe
Road valve, liquid enter dilute preparing tank；After solution has been sent in dense preparing tank, concentrated compounding spray pump is closed, reinjects the note of amount of preparation 100ml
It penetrates and is rinsed with water concentrated compounding top tank structure, be then turned on concentrated compounding spray pump, wash water is sent to dilute preparing tank, water for injection has been sent in dense preparing tank
Afterwards, dense preparing tank bottom pipeline valve is closed.
In dilute preparing tank plus water for injection 600ml is to amount of preparation, and has reviewing officer's confirmation, stirs 10 minutes, after uniform,
Dilute preparing tank bottom pipeline valve and reflux line valve are opened, opens refined filtration pump circulation 15 minutes, sodium selenite dimension is obtained after filtering
Raw element C parenteral solutions, are then filled out " asking verification certificate ", are sampled by QA, detection liquid content, pH value project.
(2) key process parameter：
Inspection verification is carried out to supplementary material, including the name of an article, lot number, quantity, manufacturer, eligible state；
It weighs and checks；
Sterilising temp, the sterilization time of material-compound tank：121 DEG C, 30 minutes.
(3) control among：The detection of feed liquid after preparation includes control among character, solution colour, solution clarity, pH value etc.
System：
During preparation, it is necessary to which operated by two people, a people master match somebody with somebody, people review, the addition and adjustment of each supplementary material, it is necessary to by
It checks people to confirm, two people must sign on record；
Temperature in process for preparation adjust and prepare it is last be quantitatively intended to reviewing officer's confirmation, and have operating personnel and
Reviewing officer signs；
The detection of parenteral solution is paid attention to after preparation, includes character, solution colour, solution clarity, pH value etc..
Process 4：Aseptic filtration
(1) parenteral solution, through 0.45 μm, 0.22 μm of micropore cartridge type membrane filter, is followed through after the assay was approved, opening refined filtration pump
Ring samples after filtering 15 minutes, checks clarity of injection, and after qualified, closing volume pipeline valve is opened into high-order barrel
Road valve, liquid enter in head tank up to after a certain amount of, close refined filtration pump, start embedding, open refined filtration pump at any time to keep high
The amount of position slot inner liquid medicine, filtering finish, and carry out integrity test to 0.22 μm of filter core, determine that filter core stands intact.
(2) key process parameter：
The sterilising temp and sterilization time of bacterial filter：121 DEG C, 30 minutes；
Circulating filtration 15 minutes.
(3) control among：
Pressure monitor should be carried out to ultrafilter, in the filter process of liquid after medical filtration, to 0.22 μm
Filter core carries out bubbling point experiment, confirms that filter is in normal condition in entire transmission process；
After the completion of drug solution preparing, it is necessary to interior completion embedding and sterilizing when 24 is small.
Process 5：Embedding
(1) personnel check clear out a gathering place situation and equipment state, each component composition of irrigator are filled by regulation into embedding post
Injection system is mounted on bottle placer, with filtered water for injection douche can injection system.
It is operated by Product Process regulation, start examination fills, and checks that loading amount, sealing start to fill after meeting quality control standard
Envelope operates, and in potting process, checks a loading amount within every 30 minutes, should be adjusted in time when there is deviation.
Operating personnel cannot arbitrarily leave in potting process, should observe bottle inlet, loading amount, sealing situation, machine run at any time
Steady situation is answered hard stop inspection if any abnormal, is turned back on again after the processing that ascertains the reason.
The good ampoule of embedding is fitted into stainless steel disc, sterilizing cup is reached by passing cabinet；After picking out defective work, put
Enter in defective work disk.
(2) key process parameter：
Loading amount：10ml
The pressure of each machine inflated with nitrogen：0.01-0.02Mpa
(3) control among：
10.1~10.5ml of content scope
Sealing：Ying Yuanzheng, length are basically identical, are not allowed have bubble head, band spine, torticollis and apparent concave head；
Loading amount detects：Check a loading amount within every 30 minutes, the loading amount of every must not be less than its labelled amount；
Liquid is formulated into sterilizing certainly to be terminated, it is necessary to the interior completion when 24 is small.
Process 6：Sterilizing leak detection
(1) personnel by regulation into sterilizing leak detection post, clear out a gathering place situation and equipment state by inspection, by predetermined operation sterilizing cabinet,
Sterilization time be from when in sterilizer temperature rise to set point of temperature and start the clock, by regulation sterilising temp and sterilization time into
Row sterilizing.
Sterilizing finishes the leak detection stage that is transferred to, and vacuum valve is opened, is evacuated to more than -0.08Mpa, and vacuum valve is closed,
The leak detection water-soluble tank valve of color is opened, when reaching upper water level, is stopped into leak detection color aqueous, and starts to hunt leak, after the time arrives, pressure
Contracting air door is opened, and leakage color aqueous of listing and indexing is opened spare penstock, once cleaned；After scavenging period arrives, into spare water
Valve is closed, and steam discharge penstock is closed when water level is less than lower water level, drives water valve into, carries out secondary cleaning, after scavenging period arrives, row
Water.
Ending phase：It is bright to terminate lamp, steam discharge water valve is opened, and when interior chamber pressure is zero, by rest button, Program reset can
To open sterilization cabinet door.
(2) key process parameter：
Sterilize steam pressure：0.3~0.6Mpa
Sterilization process condition：105 DEG C of steam sterilizings 30 minutes；Leak detection color water：Three-coloured amaranth red water；Negative pressure during leak detection：-
0.08Mpa。
It is vacuumized during leak detection：To -0.080Mpa；
Color aqueous is 2/100000ths amaranth solution, is replaced once within 3 days.
(3) control among：
When getting drug, it is whether consistent with product handing-over card request that title, quantity, specification of led drug etc. should be checked.
Drug should the interior sterilizing when 4 is small after embedding.
Process 7：Lamp inspection
(1) personnel by regulation into lamp inspection post, clear out a gathering place situation and equipment state by inspection, to the product after sterilizing one by one into
Portable lighter is examined.
(2) key process parameter：Nothing.
(3) control among：
Clarity testing staff's condition：Remote and closely eyesight inspection, is 0.9 or more than 0.9；Reviewer should
Without colour blindness, eyesight status checks once every year, and continuous lamp inspection 2 will rest 15 minutes when small.
Product visible foreign matters detect：Taking every time, 2 elder generations are static upright, and transverse direction of then falling, finally gently overturning is stood upside down
Under black background, whether there are color dot, fiber, glass etc. in visual inspection glass bottle, then visual inspection is under white background after gently overturning
No to have stain, the time limit is no less than 5 seconds, and the fine visible foreign matters of finding (the short fibre under such as pointing object, 2mm in the time limit is checked in regulation
Peacekeeping block etc.) must not have, hence it is evident that visible foreign matters (metal fillings, chips of glass, length or maximum particle diameter more than 2mm fiber and
Block etc.) it must not promising qualification.
Process 8：Lettering, packaging
(1) personnel check clear out a gathering place situation and equipment state, according to (packaging directive list) by regulation into lettering, packaging post
This batch of required packaging material is got, and checks that packaging material has the quality certification, meets quality criteria requirements, is recorded accordingly
Upper signature；It is operated according to packaging production ordering, lot number, the term of validity, date of manufacture printing, QA inspector's inspection is carried out to label
Can formally be printed after looking into qualification, by put bottle → lettering → mounted box → put specification → vanning → storage (custody for account of customers is to be checked) sequentially into
Row operation.
(2) key process parameter：Nothing.
(3) control among：
The inspection review of imprint；
Packaging material material balance：Tag class material balance is 100%, other packaging material material balances are 98-
100%.
Key production technology thereof parameter
The production equipment mainly used
Finally it should be noted that：Above example is only to illustrate the present invention and not limits technology described in the invention
Scheme；Therefore, although this specification with reference to above-mentioned each embodiment to present invention has been detailed description, this
Field it is to be appreciated by one skilled in the art that still can modify to the present invention or equivalent substitution；And all do not depart from this
The technical solution of the spirit and scope of invention and its improvement should all be covered in scope of the presently claimed invention.
Claims (2)
1. a kind of sodium selenite vitamin C parenteral solutions, including raw material and auxiliary material, it is characterised in that：The raw material includes sub- selenium
Sour sodium and vitamin C, wherein by weight, using sodium selenite 1g, vitamin C 50g；The auxiliary material includes ethyl alcohol, poly- mountain
Pear ester -80 and water for injection, wherein by weight, using ethyl alcohol 50ml, Tween-80 100ml and water for injection 1000ml.
2. a kind of sodium selenite vitamin C parenteral solution manufacturing methods according to claim 1, which is characterized in that it is manufactured
Method includes：
1) the middle water for injection for injecting 300ml in dense preparing tank, is passed through CO2It is allowed to saturation；
2) feeding port is closed after adding in sodium selenite 1g after previous step, is stirred 15 minutes at 60 DEG C, is completely dissolved it；
3) vitamin C 50g is added after previous step, treats that CO does not occur for liquid level2During bubble, ethyl alcohol 50ml and poly- sorb are added in
Ester -80100ml solution stops stirring；
4) it is 5.0~7.0 that pH value is treated after previous step, closes feeding port, and continuing stirring makes it for 5 minutes uniformly；
5) liquid obtained after previous step enters dilute after stud filter circulation filters 15 minutes into dilute preparing tank, liquid
After distribution tank, after the water for injection of injection amount of preparation 100ml rinses in dense preparing tank, wash water is sent to dilute preparing tank in dense preparing tank；
6) add water for injection 600ml amount of preparation again in dilute preparing tank after previous step, stir 10 minutes, after uniform, by refined filtration
Pump circulation is filtered for 15 minutes, and sodium selenite vitamin C parenteral solutions are obtained after filtering.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN109512836A (en) * | 2018-12-21 | 2019-03-26 | 江西润泽药业有限公司 | A kind of sodium selenite vitamin C injection and preparation method thereof |
| CN110917209A (en) * | 2019-12-31 | 2020-03-27 | 彭咏波 | Application of selenium-containing compound or selenium nano-grade in preparation of injection or microneedle of arthritis treatment drug |
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| CN109512836A (en) * | 2018-12-21 | 2019-03-26 | 江西润泽药业有限公司 | A kind of sodium selenite vitamin C injection and preparation method thereof |
| CN110917209A (en) * | 2019-12-31 | 2020-03-27 | 彭咏波 | Application of selenium-containing compound or selenium nano-grade in preparation of injection or microneedle of arthritis treatment drug |
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Application publication date: 20180518 |