CN106124370A - A kind of method of breast grain size in quick detection fat emulsion injection - Google Patents
A kind of method of breast grain size in quick detection fat emulsion injection Download PDFInfo
- Publication number
- CN106124370A CN106124370A CN201610414676.4A CN201610414676A CN106124370A CN 106124370 A CN106124370 A CN 106124370A CN 201610414676 A CN201610414676 A CN 201610414676A CN 106124370 A CN106124370 A CN 106124370A
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- China
- Prior art keywords
- grain
- breast
- breast grain
- fat emulsion
- emulsion injection
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- Pending
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- 210000000481 breast Anatomy 0.000 title claims abstract description 49
- 238000000034 method Methods 0.000 title claims abstract description 37
- 239000007924 injection Substances 0.000 title claims abstract description 32
- 238000002347 injection Methods 0.000 title claims abstract description 32
- 239000002960 lipid emulsion Substances 0.000 title claims abstract description 29
- 238000001514 detection method Methods 0.000 title claims abstract description 16
- 239000000243 solution Substances 0.000 claims abstract description 10
- 230000000007 visual effect Effects 0.000 claims abstract description 5
- 239000008187 granular material Substances 0.000 claims abstract description 4
- 239000007788 liquid Substances 0.000 claims description 3
- 230000003321 amplification Effects 0.000 claims description 2
- 235000013336 milk Nutrition 0.000 claims description 2
- 239000008267 milk Substances 0.000 claims description 2
- 210000004080 milk Anatomy 0.000 claims description 2
- 238000003199 nucleic acid amplification method Methods 0.000 claims description 2
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 claims 2
- WGCNASOHLSPBMP-UHFFFAOYSA-N hydroxyacetaldehyde Natural products OCC=O WGCNASOHLSPBMP-UHFFFAOYSA-N 0.000 claims 1
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 abstract description 3
- 229960004063 propylene glycol Drugs 0.000 abstract 1
- 238000004519 manufacturing process Methods 0.000 description 7
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 6
- 239000000839 emulsion Substances 0.000 description 5
- 239000000047 product Substances 0.000 description 5
- 238000004458 analytical method Methods 0.000 description 4
- 235000004626 essential fatty acids Nutrition 0.000 description 4
- 239000002245 particle Substances 0.000 description 4
- 239000013256 coordination polymer Substances 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 238000007689 inspection Methods 0.000 description 3
- IIZPXYDJLKNOIY-JXPKJXOSSA-N 1-palmitoyl-2-arachidonoyl-sn-glycero-3-phosphocholine Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@H](COP([O-])(=O)OCC[N+](C)(C)C)OC(=O)CCC\C=C/C\C=C/C\C=C/C\C=C/CCCCC IIZPXYDJLKNOIY-JXPKJXOSSA-N 0.000 description 2
- 238000000149 argon plasma sintering Methods 0.000 description 2
- 239000013067 intermediate product Substances 0.000 description 2
- 239000000787 lecithin Substances 0.000 description 2
- 229940067606 lecithin Drugs 0.000 description 2
- 235000010445 lecithin Nutrition 0.000 description 2
- 239000013618 particulate matter Substances 0.000 description 2
- 238000002360 preparation method Methods 0.000 description 2
- 235000012424 soybean oil Nutrition 0.000 description 2
- 239000003549 soybean oil Substances 0.000 description 2
- 201000001320 Atherosclerosis Diseases 0.000 description 1
- 206010014198 Eczema infantile Diseases 0.000 description 1
- 102000002322 Egg Proteins Human genes 0.000 description 1
- 108010000912 Egg Proteins Proteins 0.000 description 1
- 208000004930 Fatty Liver Diseases 0.000 description 1
- 206010016260 Fatty acid deficiency Diseases 0.000 description 1
- 206010019708 Hepatic steatosis Diseases 0.000 description 1
- 208000007443 Neurasthenia Diseases 0.000 description 1
- OAICVXFJPJFONN-UHFFFAOYSA-N Phosphorus Chemical compound [P] OAICVXFJPJFONN-UHFFFAOYSA-N 0.000 description 1
- 239000000654 additive Substances 0.000 description 1
- 230000000996 additive effect Effects 0.000 description 1
- 239000003963 antioxidant agent Substances 0.000 description 1
- 230000003078 antioxidant effect Effects 0.000 description 1
- 206010003549 asthenia Diseases 0.000 description 1
- 201000008937 atopic dermatitis Diseases 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 239000012895 dilution Substances 0.000 description 1
- 238000010790 dilution Methods 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 238000006073 displacement reaction Methods 0.000 description 1
- 238000009826 distribution Methods 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 230000000857 drug effect Effects 0.000 description 1
- 239000003995 emulsifying agent Substances 0.000 description 1
- 230000001804 emulsifying effect Effects 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 208000010706 fatty liver disease Diseases 0.000 description 1
- 239000011521 glass Substances 0.000 description 1
- 239000003978 infusion fluid Substances 0.000 description 1
- 239000004615 ingredient Substances 0.000 description 1
- 238000001990 intravenous administration Methods 0.000 description 1
- 238000002356 laser light scattering Methods 0.000 description 1
- 239000004531 microgranule Substances 0.000 description 1
- 235000016709 nutrition Nutrition 0.000 description 1
- 230000035764 nutrition Effects 0.000 description 1
- 239000003921 oil Substances 0.000 description 1
- 235000019198 oils Nutrition 0.000 description 1
- 210000004681 ovum Anatomy 0.000 description 1
- 150000002978 peroxides Chemical class 0.000 description 1
- 239000000546 pharmaceutical excipient Substances 0.000 description 1
- 229910052698 phosphorus Inorganic materials 0.000 description 1
- 239000011574 phosphorus Substances 0.000 description 1
- 230000005855 radiation Effects 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 231100000240 steatosis hepatitis Toxicity 0.000 description 1
- 230000001954 sterilising effect Effects 0.000 description 1
- 239000013589 supplement Substances 0.000 description 1
- 210000003462 vein Anatomy 0.000 description 1
Classifications
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N15/00—Investigating characteristics of particles; Investigating permeability, pore-volume or surface-area of porous materials
- G01N15/02—Investigating particle size or size distribution
- G01N15/0205—Investigating particle size or size distribution by optical means
Landscapes
- Chemical & Material Sciences (AREA)
- Dispersion Chemistry (AREA)
- Physics & Mathematics (AREA)
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Analytical Chemistry (AREA)
- Biochemistry (AREA)
- General Health & Medical Sciences (AREA)
- General Physics & Mathematics (AREA)
- Immunology (AREA)
- Pathology (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Apparatus For Radiation Diagnosis (AREA)
Abstract
The present invention proposes a kind of method of breast grain size in quick detection fat emulsion injection, including step: take fat emulsion injection on microscope slide, add 1,2 propylene glycol solutions, build coverslip, be placed under microscope and inspect, focus to breast grain show granule clearly, observe ten visuals field, and measure the diameter of breast grain.The present invention uses microscopic method detection fat emulsion injection breast grain size simple to operate, it is not necessary to being diluted, the operating time is short.
Description
Technical field
The invention belongs to detection field, be specifically related to a kind of detect the method for granular size in emulsion.
Background technology
One of ingredient of intravenous nutrition, provides energy and essential fatty acid for body, supplements for parenteral alimentation
Energy and essential fatty acid, prevent and treat essential fatty acid deficiency disease, also can not maintain and recover for oral route
The patient of normal essential fatty acid level provides essential fatty acid.Lecithin can assist treatment atherosclerosis, fatty liver, with
And infantile eczema, neurasthenia.The antioxidant of solubilizing agent, emulsifying agent and oils is made in pharmaceutic adjuvant.
Newborn grain size in fat emulsion injection directly affects intravenous fluid effect and drug effect, be one very important
Testing index.2015 editions Chinese Pharmacopoeias are as follows to fat milk breast grain size requirements: " in the emulsion type injection of vein 90%
Emulsion droplet size should must not have the emulsion droplet more than 5 μm below 1 μm.”
Fat emulsion injection typically uses electric-resistivity method (coulter counter method) and light scattering method to breast grain inspection.Resistance
Method, i.e. coulter counter method, be to allow particulate matter displacement in constant aperture conduit, when particulate matter volume far away
Be proportional to microgranule volume less than sensor output pulse amplitude during little blank pipe aperture, be i.e. proportional to mean particle dia cube, but
Must add conducting solution in detection, prepare this solution min length and easily cause pollution, the cost of use improves the most therewith.Light
Scattering method, is a kind of particle size detection method based on laser light scattering principle, and the laser launched when laser diode passes pin hole, and
Particle radiation in sample groove, the light scattered by sample particle returns through incident light rays, and the mirror fixed reflects, so
Rear entrance photodetector, the analogue signal detected will be exaggerated, be converted to digital signal, and the method is also required to equally to sample
It is diluted, complex operation, it is crucial that the newborn grain more than 5um can not be detected.The time of both the above method detection is the most very
Long.
In actual production, if the size using both the above method to control intermediate products breast grain is at least required for two
Hour time, this will affect the performance of its production capacity, and medicinal liquid is placed for a long time in distribution tank, can increase fat emulsion injection
In lysophosphatide and the increase of peroxide value, so can affect the curative effect of medicine.Therefore, when the inspection of intermediate products, need
Bring a kind of inspection method rapidly and efficiently, shorten the product time at process for preparation as far as possible.
Summary of the invention
In place of the deficiencies in the prior art, the purpose of the present invention is to propose to breast in a kind of quickly detection fat emulsion injection
The method of grain size.
The technical scheme realizing the object of the invention is:
A kind of method of breast grain size in quick detection fat emulsion injection, including step: take fat emulsion injection in load
On slide, add 1,2-PD solution, build coverslip, be placed under microscope and inspect, focus to breast grain show clearly
Granule, observes ten visuals field, and measures the diameter of breast grain.Separately take a sample with a fat emulsion injection, in kind survey
Fixed breast grain diameter, twice testing result is averaged the diameter into final breast grain.
Further, take fat emulsion injection 1 on microscope slide, add 1,2-PD solution 1-2 and drip, build lid glass
Sheet, is placed under microscope and inspects, and described microscopical amplification is 100 times～200 times.
Wherein, the mass concentration of described 1,2-PD solution is 40～60%.
Method of the present invention, measures the diameter of breast grain by the micrometer of the included demarcation of eyepiece, controls 80～100%
Newborn grain be below 0.5 μm, more than in 0.5 μm breast grain sum, 3% must not be crossed more than the newborn grain number of 1 μm.Described micrometer
Width is every lattice 0.1 μm.
Preferably, by measure breast grain diameter, control 95～100% newborn grain be below 0.5 μm, more than 0.5 μm
In breast grain sum, 2.6% must not be crossed more than the newborn grain number of 1 μm.
The invention have the advantages that
Use microscopic method detection fat emulsion injection breast grain size simple to operate, it is not necessary to be diluted, the operating time
Short.In this approach breast grain size in fat emulsion injection production process is controlled, the strictest control mark can be carried out
Accurate (GB only requires that, more than 1 μm, this method measures 0.5 μm), improves product quality.
We carry out retrospective analysis to the fat emulsion injection product breast grain size of our factory in 2014.2014 01 month 01
Day December in 2014 our factory on the 31st produces 161 batches the whole year altogether, more than the meansigma methods of newborn grain number of 1 μm in statistics breast grain:
1.6%, peak: 2.6%, minimum: 0.7%, standard deviation: 0.435%, CP value: 1.15, divides from statistical data and trend
Analysis can show that the fat emulsion injection breast grain of production, all in the range of internal control and without beyond upper and lower limit, illustrates in production process
In in this approach can be good at control fat emulsion injection breast grain size, and the method detection fat emulsion injection breast grain big
Little steady quality.
Accompanying drawing explanation
Fig. 1 is the newborn grain size variation trendgram of the detection of the embodiment of the present invention 1.
Detailed description of the invention
Following example are used for illustrating the present invention, but are not limited to the scope of the present invention.
In embodiment, if no special instructions, method therefor and equipment are the conventional equipment in this area and method.
Embodiment 1:
The sample of detection is the fat emulsion injection product that this enterprise produces, and is through injection ovum phosphorus by injection soybean oil
The sterilizing emulsion liquid that fat emulsifying glycerol adding are made, containing 50g soybean oil, 3g lecithin and 5.625g glycerol in every 250m1.
Taking fat emulsion injection 1 and add 50%1 on microscope slide, 2-propylene glycol solution 1-2 drips, and builds coverslip, puts
Big multiple is to inspect under the high power microscope of 100 times, focuses and shows granule clearly to breast grain, observes ten visuals field, lead to
The micrometer (every lattice 0.1 μm) crossing the included demarcation of eyepiece measures the diameter of breast grain, and most breast grain should be about 0.5 μm,
More than in 0.5 μm breast grain sum, 3% must not be crossed more than the newborn grain number of 1 μm.Separately take a sample, in kind measure breast grain straight
Footpath, twice testing result meansigma methods is the diameter of final breast grain.This method simple operation, sample need not dilution, and sample preparation is also united
Count ten visuals field and need 5～10 minutes altogether.
In this approach breast grain size in fat emulsion injection production process is controlled, our fat to our factory in 2014
Fat emulsion injection product breast grain size carries out retrospective analysis.2014 01 month 2014 on the 01st Decembers our factory on the 31st is total to the whole year
Produce 161 batches, more than the meansigma methods of newborn grain number accounting of 1 μm in breast grain number: 1.6%, peak: 2.6%, minimum:
0.7%, standard deviation: 0.435%, CP value: 1.15,
The computing formula of CP is
Tu is the upper deviation, and TL is lower deviation, and σ is standard deviation.
Statistical result is shown in Table 1.In table, " lot number " represents sample lot number.
Table 1:161 criticizes breast grain size
Fig. 1 illustrates the newborn grain size variation trendgram that the present embodiment detects.In Fig. 1, alert limit is this enterprises mark
Standard, alert limit is 3.0%, and meansigma methods is 1.6%.
Can show that the fat emulsion injection breast grain of production is all in the range of internal control and nothing from statistical data and trend analysis
Beyond upper and lower limit, illustrate to can be good at controlling fat emulsion injection breast grain size the most in this approach, and should
Method detection fat emulsion injection breast grain size steady quality.
Although present disclosure has been made to be discussed in detail by above-mentioned preferred embodiment, but it should be appreciated that above-mentioned retouching
State and be not considered as limitation of the present invention.It will be understood by those skilled in the art that open in this patent design and specific embodiment
Under showing, it is possible to some deformation directly derived from this patent disclosure and general knowledge or associate, those of ordinary skill in the art
Will be recognized by may be used without additive method, or the replacement of prior art, and the equivalence of feature changes or modifies, or between feature
Mutually different combination, can realize this patent describe function and effect, illustrate the most one by one, all belong to this patent protection
Scope.
Claims (5)
1. the method for breast grain size in a quick detection fat emulsion injection, it is characterised in that include step: take fat milk note
Penetrate liquid on microscope slide, add 1,2-PD solution, build coverslip, be placed under microscope and inspect, focus to breast grain and show
Show granule clearly, observe ten visuals field, and measure the diameter of breast grain；A sample is separately taken, with same with a fat emulsion injection
Quadrat method measures breast grain diameter, and twice testing result is averaged the diameter into final breast grain.
Method the most according to claim 1, it is characterised in that take fat emulsion injection 1 and add 1 on microscope slide, 2-third
Glycol solution 1～2, build coverslip, be placed under microscope and inspect, and described microscopical amplification is 100 times～200
Times.
Method the most according to claim 1 and 2, it is characterised in that the mass concentration of described 1,2-PD solution is 40
～60%.
Method the most according to claim 1, it is characterised in that measure the straight of breast grain by the micrometer of the included demarcation of eyepiece
Footpath, control 80～100% newborn grain be below 0.5 μm, more than in 0.5 μm breast grain sum, must not mistake more than the newborn grain number of 1 μm
3%；The width of described micrometer is every lattice 0.1 μm.
Method the most according to claim 4, it is characterised in that by measuring the diameter of breast grain, control 95～the breast of 100%
Grain is below 0.5 μm, more than in 0.5 μm breast grain sum, must not cross 2.6% more than the newborn grain number of 1 μm.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610414676.4A CN106124370A (en) | 2016-06-06 | 2016-06-06 | A kind of method of breast grain size in quick detection fat emulsion injection |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610414676.4A CN106124370A (en) | 2016-06-06 | 2016-06-06 | A kind of method of breast grain size in quick detection fat emulsion injection |
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| Publication Number | Publication Date |
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| CN106124370A true CN106124370A (en) | 2016-11-16 |
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| CN201610414676.4A Pending CN106124370A (en) | 2016-06-06 | 2016-06-06 | A kind of method of breast grain size in quick detection fat emulsion injection |
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Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20060132771A1 (en) * | 2004-11-30 | 2006-06-22 | Tokyo Electron Limited | Particle detecting method and storage medium storing program for implementing the method |
| CN101493398A (en) * | 2009-03-04 | 2009-07-29 | 大庆油田有限责任公司 | Emulsified crude oil emulsion laser co-focussing analytical method |
| CN101496787A (en) * | 2009-01-20 | 2009-08-05 | 李淑斌 | Prostaglandin E1 lipid microsphere injection with charge effect and preparation method thereof |
| CN102552134A (en) * | 2012-02-13 | 2012-07-11 | 西安安健药业有限公司 | Fat emulsion containing vitamin K1 |
| JP2015059775A (en) * | 2013-09-17 | 2015-03-30 | ポーラ化成工業株式会社 | Evaluation method and production method of emulsion cosmetics |
-
2016
- 2016-06-06 CN CN201610414676.4A patent/CN106124370A/en active Pending
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20060132771A1 (en) * | 2004-11-30 | 2006-06-22 | Tokyo Electron Limited | Particle detecting method and storage medium storing program for implementing the method |
| CN101496787A (en) * | 2009-01-20 | 2009-08-05 | 李淑斌 | Prostaglandin E1 lipid microsphere injection with charge effect and preparation method thereof |
| CN101493398A (en) * | 2009-03-04 | 2009-07-29 | 大庆油田有限责任公司 | Emulsified crude oil emulsion laser co-focussing analytical method |
| CN102552134A (en) * | 2012-02-13 | 2012-07-11 | 西安安健药业有限公司 | Fat emulsion containing vitamin K1 |
| JP2015059775A (en) * | 2013-09-17 | 2015-03-30 | ポーラ化成工業株式会社 | Evaluation method and production method of emulsion cosmetics |
Non-Patent Citations (6)
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|---|
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| 医学百科: "脂肪乳注射液", 《医学百科：HTTPS://WWW.WIKI8.COM/ZHIFANGRUZHUSHEYE_25535/SIMILAR.HTML》 * |
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Application publication date: 20161116 |