CN106198526A - A kind of assay method of high-capacity injection quality examination - Google Patents
A kind of assay method of high-capacity injection quality examination Download PDFInfo
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- CN106198526A CN106198526A CN201610546242.XA CN201610546242A CN106198526A CN 106198526 A CN106198526 A CN 106198526A CN 201610546242 A CN201610546242 A CN 201610546242A CN 106198526 A CN106198526 A CN 106198526A
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
- G01N21/77—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
- G01N21/78—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator producing a change of colour
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Abstract
The invention discloses the assay method of a kind of high-capacity injection quality examination, use filter membrane filtration method that high-capacity injection quality carries out membrane filtration residual item inspection.Assay method of the present invention not only measurement result is accurate, with strong points, it is wide to reflect, and simple to operate, production cost is low, measurement result is directly perceived without dispute, the more important thing is and high-capacity injection is proposed requirements at the higher level, reduce the quality safety risk of high-capacity injection, it is ensured that medication is reasonable, safety.Compared with existing high-capacity injection quality examination project, the present invention is all applicable to the quality of pharmacy corporation production process intermediate products and checks on and quality examination before product export.
Description
Technical field
The present invention relates to pharmaceutical preparation technical field of quality detection, be specifically related to a kind of high-capacity injection quality examination
Assay method.
Background technology
Injection is the one in injection.Injection means that body is injected in material medicine or the confession made with suitable adjuvant
Interior sterile liquid formulations, the injection such as including solution-type, emulsion type or suspension type.Large Copacity for intravenous drip is injected
Liquid (unless otherwise specified, typically no less than 100ml, biological product are typically no less than 50ml) alternatively referred to as transfusion.Chinese medicine injection
Agent typically should not make suspension type injection.
Injection should meet the following requirements during storage in production.One, solution-type injection should be clarified；Unless otherwise specified
Outward, in suspension type injection, raw material diameter of aspirin particle should control below 15 μm, containing 15-20 μm (have indivedual 20-50 μm) person, no
, should easily should be uniformly dispersed during shaking if there being visible precipitate more than 10%.Suspension type injection must not be used for intravenous injection or vertebra
Injection in pipe；Emulsion type injection, must not have phenomenon of phase separation, must not be used for spinal injection；Vein emulsion type is injected
In liquid, the emulsion droplet size of 90% should must not have the emulsion droplet more than 5 μm below 1 μm.Unless otherwise specified, transfusion should as far as possible with
Blood is isotonic.Two, the supplementary material used by injection should strictly control from links such as source and production technologies and should meet note
The prescription penetrated.Three, injection solvent for use should be safe and harmless, and compatible with other medicinal ingredients good, must not shadow
Ring curative effect and the quality of active component.It is generally divided into aqueous solvent and non-aqueous solvent.Four, during preparation injection, can be according to need
Add suitable additives, such as osmotic pressure regulator, pH value regulator, solubilizing agent, cosolvent, antioxidant, antibacterial, emulsifying
Agent, suspending agent etc..Additives used should not affect curative effect of medication, it is to avoid inspection is produced interference, and concentration must not cause poison
Property or obvious zest.Conventional antioxidant has sodium sulfite, sodium sulfite and sodium pyrosulfite etc., and general concentration is
0.1%-0.2%.The injection of multiple-unit container can add suitable antibacterial, and the consumption of antibacterial should be able to suppress micro-in injection
Biological growth, unless otherwise specified, when preparation determines prescription, the inhibitory effect of this prescription should meet inhibitory effect inspection technique
The regulation of (general rule 1121).Added with the injection of antibacterial, suitable method sterilizing must be used.In intravenously administrable and brain pond,
Epidural, the injection of intraspinal tube all must not add antibacterial.Conventional antibacterial be 0.5% phenol, 0.3% cresol, 0.5%
Chlorobutanol, 0.01% thimerosal etc..Five, injection commonly uses container glass ampule, vial, plastic ampoule, plastic bottle
(bag), prepackage type syringe etc..Six, the preparation time should be shortened as far as possible in the production process of injection, prevent microorganism with
The pollution of pyrogen and material medicine go bad.The process for preparation of transfusion more should strictly control.Prepare suspension type injection, emulsion type
During injection, the measure of necessity to be taked, it is ensured that particle size meets the requirement of quality standard.Injectable sterile powder should
Prepare by sterile working.Injection should carry out corresponding security inspection if desired, as undue toxicity, anaphylaxis, haemolysis with
Cohesion, depressor substance etc., all should meet the requirements.Seven, when fill indicates the injection that loading amount is no more than 50ml, should be suitable by regulation
When increasing loading amount.Should sealing by fusing or sternly seal as early as possible after injection fill.The material medicine that ingress of air is perishable, at pouring process
In, the air in container should be got rid of, can the gas such as filling arbon dioxide or nitrogen, immediately sealing by fusing or sternly seal.Thermally sensitive former
Material medicine should control temperature in potting process, and injection should be placed in after completing at a temperature of regulation and store by embedding immediately.System
During standby freeze-drying preparation for injection, should lyophilization in time after subpackage.After lyophilizing, residual moisture should meet the requirement of relevant kind.Raw
The subpackage of Tetramune and lyophilizing, should also conform to the requirement of " biological product subpackage and lyophilizing code ".Eight, injection sealing by fusing or sternly seal
After, typically suitable method should be selected to carry out sterilizing according to material medicine character, it is necessary to assure manufactured goods are aseptic.Injection should be adopted
Container leak detection is carried out by proper method.Nine, unless otherwise specified, injection answers shading to store.Biological product stock solution, semi-finished product and
The Production and quality control of finished product should meet relevant kind requirement.Ten, the label of injection or description should indicate wherein institute
By the title of adjuvant, kind and the concentration of antibacterial also should be indicated if any antibacterial；Injectable sterile powder should indicate that preparation is molten
Solvent species used by liquid, the most also should mark quantity of solvent.Unless otherwise specified, " Chinese Pharmacopoeia " version four (0102) in 2015
Injection is defined following items inspection.1, loading amount.2, content uniformity.3, osmotic pressure molar density.4, visible foreign matters.5, no
Dissolubility microgranule.6, Chinese medicine has related substance.7, Residue of heavy metals and harmful elements amount.8, aseptic.9, bacterial endotoxin or
Pyrogen.The most existing injection quality examination project is statutory standards.
The high-capacity injection such as manufacturer such as glucose injection, sodium chloride injection is usually the production according to official written reply
Technique and prescription produce, and product quality detects according to statutory standards.If the product that pharmaceutical producing enterprise is to regulation
Quality examination project carries out changing or increase inspection project needs declaration again, and the human and material resources etc. that so can increase enterprise become
This.Therefore, since there being the drug quality of standardization to check project, pharmaceutical production producer typically will not arbitrarily increase drug quality
Inspection project.But, along with the progress in epoch, the development of society and the expansion application of drug quality analytical technology, clinic makes
With the quality and safety control increasingly stringent to drug quality safety particularly high-capacity injection medicine, to existing Large Copacity
The improvement of injection quality examination project or increase, also in constantly exploration is carried out, improve each time or increase high-capacity injection
Quality examination project is all the most perfect to existing high-capacity injection quality control, is the most also improving medication
Reasonability, safety.
Summary of the invention
The object of the invention is to increase existing high-capacity injection quality examination project, for improving high-capacity injection quality peace
Full property provides a kind of new routine examination project.
The present invention uses filter membrane filtration method that high-capacity injection quality carries out membrane filtration residual item inspection, will select
A diameter of 50mm, (measuring samples solvent is that aqueous solvent selects water system filter membrane, non-aqueous solvent for the filter membrane of aperture≤0.45 μm
Select organic system filter membrane) it is fixed on sucking filtration cup, moisten filter membrane with a small amount of water, take test sample 10 bottles (propping up), the least before filtering
The heart overturns 5 times, careful unlatching test sample container, test sample medicinal liquid is poured in sucking filtration cup, covers sucking filtration bowl cover, open sucking filtration
Device, directly filters.Sucking filtration will be continued 10 seconds after 10 bottles of whole filtrations of test sample, take out filter membrane, dry, check membrane filtration table
, must not there be clearly visible foreign body in face: must not show the color different from test sample.
The assay method of a kind of high-capacity injection quality examination of the present invention, specifically includes following steps:
1) prepare before measuring:
1. filter membrane: require a diameter of 50mm, aperture≤0.45 μm；
2. filtration system: be made up of bottle,suction and nutsch filter, after bottle,suction is cleaned, seals bottle,suction and nutsch filter even
After connecting, access power supply, stand-by；
2) test sample prepares:
Take test sample 10 bottles, standby after cleaning clean vessel surface；
3) measure:
Ready filter membrane is fixed on sucking filtration cup, moistens filter membrane with a small amount of water for injection, take test sample 1 bottle, carefully
Overturn 5 times, open test sample container, in carefully pouring test sample medicinal liquid into filter cup immediately and cover bowl cover, open nutsch filter,
Directly by test sample medical filtration, with method by remaining 9 bottles of whole filtration of test sample, after 10 bottles of whole filtrations of test sample complete,
Continue sucking filtration 10 seconds, stop filtering, empty filtration system, carefully take out filter membrane, dry, inspect filter membrane table at highlight
Face；
Result judges: must not there be the visible foreign matters such as color dot, color lump, white block, length fibre in membrane filtration face, and membrane filtration face is not
Must produce and test sample medicinal liquid different colours.
Step 1 of the present invention) described in filter membrane include water system filter membrane and organic system filter membrane, measuring samples solvent is aqueous solvent
Selecting water system filter membrane, non-aqueous solvent selects organic system filter membrane.
Step 2) described in test sample 10 bottles can also be test sample 10.
Compared with prior art, the invention have the advantages that
1, measurement result is accurate, with strong points, it is wide to reflect
Affecting high-capacity injection qualitative factor a lot, production process is raw materials used, the container of adjuvant, additives, splendid attire,
And Agitation Tank used by dosing subpackage, conveyance conduit, fill mouth etc. all may have influence on high-capacity injection quality.In the face of big
Volume injection liquid quality is the fact that factor affects in many ways, and existing statutory standards " Chinese Pharmacopoeia " version in 2015 defines multinomial quality
Check, but existing statutory standards " Chinese Pharmacopoeia " version in 2015 inspection project that high-capacity injection specify exist comprehensive or
The not strong phenomenon of specific aim.
According to investigations, at present a lot of high-capacity injection manufacturers all use stainless steel and iron plasmogamy flow container, conveyance conduit and
Fill mouth, these dosings and subpackage apparatus, due to life-time service, particularly prepare " salt " property products such as sodium chloride injection more
Time, these dosings and subpackage apparatus are most likely subject to corrosion and produce " rust ", if cleaning unreasonable before preparating liquid or filtering
(filter element) is insufficient, and " rust " the yellow foreign body that medicinal apparatus can be produced mixes into the liquid, causes in product medicinal liquid and is mixed with " ferrum
Rust ".When " rust " amount is bigger, may detection by present statutory audit method " Chinese Pharmacopoeia " version visible foreign matters inspection technique in 2015
Out, when " rust " is measured less, examine by present statutory audit method " Chinese Pharmacopoeia " version visible foreign matters inspection technique in 2015 at all
Do not measure, survey with other check item visual inspections of present high-capacity injection statutory standards " Chinese Pharmacopoeia " version regulation in 2015
" rust " is the most irrelevant.This results in erroneous judgement, allows substandard product dispatch from the factory, and causes serious health to vast user
Harm.And use assay method of the present invention, test sample 10 bottle liquid medicine is all filtered, due to filter membrane footpath aperture≤0.45 μ
M, problematic " rust " (no matter measure many or amount is few), directly filtration residue is on filter membrane, by inspection filter membrane residual condition just
Can determine whether test sample whether with " rust ", if in test sample exist " rust ", filter membrane can become brown color, even on filter membrane
Being found to have small brown yellow granule, " rust " that this just accurately can bring test sample in process of production checks out.
According to investigations, the high-capacity injection of existing market circulation is mostly polypropylene transfusion bottle packaging.Polypropylene transfusion bottle
The high-capacity injection product of packaging is when production process sealing by fusing operation, owing to polypropylene transfusion bottle and polypropylene combination cover are mutual
Rub and polypropylene plastics tablet or silk may be produced, may produce due to heating plate scratch polypropylene transfusion bottle mouth and composite cover
Polypropylene plastics tablet or silk.There is a strong possibility drops to infusion bottle medicinal liquid when sealing by fusing for these polypropylene plastics tablets produced or silk
In.The density of polypropylene plastics tablet or silk is less than medicinal liquid and swims on liquid level, add polypropylene plastics tablet or silk color and
Polypropylene bottle is the same, missing inspection when easily causing lamp inspection.Cause portioned product with plastic sheet or silk visible foreign matters, when these
May by present statutory audit method " Chinese Pharmacopoeia " version visible foreign matters inspection technique in 2015 when polypropylene plastics tablet or silk amount are bigger
Detect, visible by present statutory audit method " Chinese Pharmacopoeia " version in 2015 when these polypropylene plastics tablets or silk amount are less
Inspection of foreign substance method is the biggest may be can not be detected, by present high-capacity injection statutory standards " Chinese Pharmacopoeia " version regulation in 2015
Other check item visual inspections survey these polypropylene plastics tablets or silk is the most irrelevant.Cause missing inspection equally, allow defective
Product export.And use assay method of the present invention, test sample 10 bottle liquid medicine is all filtered, due to aperture, filter membrane footpath≤
0.45 μm, on filter membrane, is filtered problematic " plastic sheet and silk " (no matter measure many or amount is few) directly filtration residue by inspection
Film residual condition just can determine whether test sample whether with " plastic sheet and silk ", this just accurately can carry test sample in process of production
" plastic sheet and the silk " entered checks out.
In sum, assay method of the present invention has specific aim to high-capacity injection quality examination, can be the most anti-
Mirror the various insoluble observability impurity produced in high-capacity injection production process or be different from its of medicinal liquid intrinsic colour
Its color is filtered intuitively to be reflected on filter membrane.This makes high-capacity injection quality and safety be controlled comprehensively, it is ensured that
Medication is reasonable, safety.
2, measurement result is directly perceived, reduce dispute
Assay method of the present invention, by filtering " concentration " a large amount of test samples (10 bottles /), existing in test sample
Visible foreign matters impurity or heterochromatic concentrated reflection on filter membrane.Detection process is without chemical reaction, without derivative, it is not necessary to any chemistry examination
Agent, anthropic factor, machine be factor, " thing " be that factor affects measurement result and is greatly reduced.If test sample has " problem ", filtering
On residual filter membrane, absolutely clear observation is out.If test sample does not has " problem ", filtration residue filter membrane does not the most find.
Measurement result judges ocular and clear, undisputed.
3, operating procedure is simple, low cost
Operating procedure of the present invention is only with common nutsch filter sucking filtration test sample medicinal liquid, directly testing result reaction is existed
On filter membrane, it is not necessary to prepare any reagent, test solution, it is not necessary to require strict experiment condition and complicated detecting step, detect consumptive material
Being only filter membrane, the instrument of use is common nutsch filter and bottle,suction, precision instrument that need not be expensive.According to investigations, existing market is filtered
Film (diameter 50mm, aperture 0.45 μm) be only 0.3 yuan, common sucking filtration system be also only 700～900 yuan a set of, this is substantially reduced
Testing cost.
Detailed description of the invention
With embodiment, the invention will be further described below, but the invention is not limited in these embodiments.
Embodiment:
A kind of high-capacity injection quality examination assay method, comprises the following steps:
1, measuring samples is: Dextrose and Sodium Chloride Inj., and specification is 250ml/ bottle；
2, prepare before measuring:
(1) filter membrane: Tian Jinjin rises micropore filtering film (water system), diameter 50mm, aperture 0.45 μm, 50/box, selects intact
Foreign filter membrane is standby；
(2) sucking filtration system: Tian Jinjin rises vacuum diaphragm pump, model Gm-0.33；Tian Jinjin rises T-50 solvent filter；
(3) clean bottle,suction with water for injection the most standby, take 10 bottles of cleaning container clean in appearance of test sample standby；
3, measure:
Connect filter and vacuum diaphragm pump, ready filter membrane is fixed on sucking filtration cup, use a small amount of water for injection
Moistening filter membrane, takes 1 bottle of sample, is carefully turned over 5 times, opens test sample container, in carefully pouring medicinal liquid into filter cup immediately and cover
Upper bowl cover, opens vacuum diaphragm pump, is directly filtered by test sample, with method by remaining 9 bottles of whole filtration of test sample, treat test sample 10
After bottle has all filtered, continue sucking filtration about 10 seconds, stop filtering, empty filtration system, carefully take out filter membrane, dry, at light
Filter membrane surface is inspected at the line place of becoming clear；
4, result judges:
If 1. membrane filtration face does not find the visible foreign matters such as color dot, color lump, white block, length fibre, membrane filtration face does not has
It is found and test liquid different colours, it is determined that test sample meets regulation；
If 2. membrane filtration face is found to have the visible foreign matters such as color dot, color lump, white block, length fibre, or membrane filtration face
It is found to have and test liquid different colours, it is determined that test sample is against regulation.
Claims (3)
1. the assay method of a high-capacity injection quality examination, it is characterised in that comprise the following steps:
1) prepare before measuring:
1. filter membrane: require a diameter of 50mm, aperture≤0.45 μm；
2. filtration system: be made up of bottle,suction and nutsch filter, after bottle,suction is cleaned, is tightly connected bottle,suction and nutsch filter
After, access power supply, stand-by；
2) test sample prepares:
Take test sample 10 bottles, standby after cleaning clean vessel surface；
3) measure:
Ready filter membrane is fixed on sucking filtration cup, moistens filter membrane with a small amount of water for injection, take test sample 1 bottle, be carefully turned over 5
Secondary, open test sample container, in carefully pouring test sample medicinal liquid into filter cup immediately and cover bowl cover, open nutsch filter, directly
By test sample medical filtration, with method by remaining 9 bottles of whole filtration of test sample, after 10 bottles of whole filtrations of test sample complete, continue
Sucking filtration 10 seconds, stops filtering, empties filtration system, carefully take out filter membrane, dry, inspect filter membrane surface at highlight；
Result judges: must not there be the visible foreign matters such as color dot, color lump, white block, length fibre in membrane filtration face, and membrane filtration face must not be produced
Life and test sample medicinal liquid different colours.
The assay method of a kind of high-capacity injection quality examination the most according to claim 1, it is characterised in that: step 1)
Described filter membrane is water system filter membrane and organic system filter membrane, and measuring samples solvent is that aqueous solvent selects water system filter membrane, non-aqueous molten
Organic system filter membrane is selected in agent.
The assay method of a kind of high-capacity injection quality examination the most according to claim 1, it is characterised in that: step 2)
Described test sample 10 bottles is test sample 10.
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| CN201610546242.XA CN106198526A (en) | 2016-07-12 | 2016-07-12 | A kind of assay method of high-capacity injection quality examination |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN108231205A (en) * | 2017-05-27 | 2018-06-29 | 李丽 | Inpatient medication information colour atla map analysis system and method |
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| CN202044829U (en) * | 2011-03-15 | 2011-11-23 | 杭州盈天科学仪器有限公司 | Air exhaust filtering and detection device |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108231205A (en) * | 2017-05-27 | 2018-06-29 | 李丽 | Inpatient medication information colour atla map analysis system and method |
| CN108231205B (en) * | 2017-05-27 | 2021-08-10 | 李丽 | Inpatient medication information color chart analysis system and method |
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