CN109498647A - The method for preparing Dextrose and Sodium Chloride Inj. - Google Patents
The method for preparing Dextrose and Sodium Chloride Inj. Download PDFInfo
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- CN109498647A CN109498647A CN201811564915.XA CN201811564915A CN109498647A CN 109498647 A CN109498647 A CN 109498647A CN 201811564915 A CN201811564915 A CN 201811564915A CN 109498647 A CN109498647 A CN 109498647A
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- injection
- sodium chloride
- medical fluid
- microwave
- dextrose
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- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 title claims abstract description 155
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 title claims abstract description 103
- 239000011780 sodium chloride Substances 0.000 title claims abstract description 78
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 title claims abstract description 73
- 239000008121 dextrose Substances 0.000 title claims abstract description 63
- 238000000034 method Methods 0.000 title claims abstract description 53
- 230000001954 sterilising effect Effects 0.000 claims abstract description 105
- 238000004659 sterilization and disinfection Methods 0.000 claims abstract description 78
- 239000007924 injection Substances 0.000 claims abstract description 77
- 238000002347 injection Methods 0.000 claims abstract description 77
- 239000012530 fluid Substances 0.000 claims abstract description 56
- 239000008103 glucose Substances 0.000 claims abstract description 37
- 241000894006 Bacteria Species 0.000 claims abstract description 27
- 239000007788 liquid Substances 0.000 claims abstract description 21
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 12
- 239000008215 water for injection Substances 0.000 claims abstract description 8
- 238000004382 potting Methods 0.000 claims abstract description 7
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 claims description 41
- 229910052799 carbon Inorganic materials 0.000 claims description 40
- 230000005855 radiation Effects 0.000 claims description 26
- 238000012545 processing Methods 0.000 claims description 20
- 238000003756 stirring Methods 0.000 claims description 12
- 238000001514 detection method Methods 0.000 claims description 9
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims description 6
- 238000006243 chemical reaction Methods 0.000 claims description 6
- 239000011734 sodium Substances 0.000 claims description 6
- 229910052708 sodium Inorganic materials 0.000 claims description 6
- 238000001179 sorption measurement Methods 0.000 claims description 5
- 238000010894 electron beam technology Methods 0.000 claims description 4
- 239000000243 solution Substances 0.000 claims description 4
- 230000008859 change Effects 0.000 claims description 3
- ZAMOUSCENKQFHK-UHFFFAOYSA-N Chlorine atom Chemical compound [Cl] ZAMOUSCENKQFHK-UHFFFAOYSA-N 0.000 claims description 2
- 239000000460 chlorine Substances 0.000 claims description 2
- 229910052801 chlorine Inorganic materials 0.000 claims description 2
- NOEGNKMFWQHSLB-UHFFFAOYSA-N 5-hydroxymethylfurfural Chemical compound OCC1=CC=C(C=O)O1 NOEGNKMFWQHSLB-UHFFFAOYSA-N 0.000 abstract description 23
- RJGBSYZFOCAGQY-UHFFFAOYSA-N hydroxymethylfurfural Natural products COC1=CC=C(C=O)O1 RJGBSYZFOCAGQY-UHFFFAOYSA-N 0.000 abstract description 23
- 238000012360 testing method Methods 0.000 abstract description 15
- 239000008354 sodium chloride injection Substances 0.000 abstract description 13
- 239000003814 drug Substances 0.000 abstract description 9
- 238000009835 boiling Methods 0.000 abstract description 6
- 229940079593 drug Drugs 0.000 abstract description 6
- 230000009467 reduction Effects 0.000 abstract description 3
- 239000000047 product Substances 0.000 description 23
- 230000000052 comparative effect Effects 0.000 description 20
- 230000008569 process Effects 0.000 description 11
- 230000000694 effects Effects 0.000 description 10
- 238000007689 inspection Methods 0.000 description 10
- -1 polypropylene Polymers 0.000 description 10
- 239000004743 Polypropylene Substances 0.000 description 9
- 238000006731 degradation reaction Methods 0.000 description 9
- 229920001155 polypropylene Polymers 0.000 description 9
- 238000002360 preparation method Methods 0.000 description 7
- 238000003860 storage Methods 0.000 description 7
- 230000015556 catabolic process Effects 0.000 description 6
- 239000012535 impurity Substances 0.000 description 6
- 239000002994 raw material Substances 0.000 description 5
- 239000007857 degradation product Substances 0.000 description 4
- 238000001914 filtration Methods 0.000 description 4
- 239000001963 growth medium Substances 0.000 description 4
- HYBBIBNJHNGZAN-UHFFFAOYSA-N Furaldehyde Natural products O=CC1=CC=CO1 HYBBIBNJHNGZAN-UHFFFAOYSA-N 0.000 description 3
- 241000219095 Vitis Species 0.000 description 3
- 235000009754 Vitis X bourquina Nutrition 0.000 description 3
- 235000012333 Vitis X labruscana Nutrition 0.000 description 3
- 235000014787 Vitis vinifera Nutrition 0.000 description 3
- 230000001133 acceleration Effects 0.000 description 3
- 239000012752 auxiliary agent Substances 0.000 description 3
- 230000001376 precipitating effect Effects 0.000 description 3
- WNKYVCKDIDTELO-NJXYFUOMSA-N (2r)-6-hydroxy-2-(hydroxymethyl)-2h-pyran-5-one Chemical compound OC[C@@H]1OC(O)C(=O)C=C1 WNKYVCKDIDTELO-NJXYFUOMSA-N 0.000 description 2
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 2
- KZSSAVMPBHYLKP-BTVCFUMJSA-N [Cl].O=C[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO Chemical compound [Cl].O=C[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO KZSSAVMPBHYLKP-BTVCFUMJSA-N 0.000 description 2
- 239000003708 ampul Substances 0.000 description 2
- 239000003963 antioxidant agent Substances 0.000 description 2
- 230000003078 antioxidant effect Effects 0.000 description 2
- 238000005660 chlorination reaction Methods 0.000 description 2
- 238000013329 compounding Methods 0.000 description 2
- 239000005356 container glass Substances 0.000 description 2
- 238000005538 encapsulation Methods 0.000 description 2
- 210000003722 extracellular fluid Anatomy 0.000 description 2
- 238000010438 heat treatment Methods 0.000 description 2
- 150000002500 ions Chemical class 0.000 description 2
- 108090000623 proteins and genes Proteins 0.000 description 2
- 102000004169 proteins and genes Human genes 0.000 description 2
- 238000005070 sampling Methods 0.000 description 2
- 239000000725 suspension Substances 0.000 description 2
- OXFWZSUJNURRMW-NTSWFWBYSA-N 3-deoxy-keto-D-fructose Chemical compound OC[C@@H](O)[C@@H](O)CC(=O)CO OXFWZSUJNURRMW-NTSWFWBYSA-N 0.000 description 1
- ZGCHLOWZNKRZSN-NTSWFWBYSA-N 3-deoxyglucosone Chemical compound OC[C@@H](O)[C@@H](O)CC(=O)C=O ZGCHLOWZNKRZSN-NTSWFWBYSA-N 0.000 description 1
- UHPMJDGOAZMIID-UHFFFAOYSA-N 3-deoxyglucosone Natural products OCC1OC(O)C(=O)CC1O UHPMJDGOAZMIID-UHFFFAOYSA-N 0.000 description 1
- 101100515516 Arabidopsis thaliana XI-H gene Proteins 0.000 description 1
- 208000002720 Malnutrition Diseases 0.000 description 1
- AIJULSRZWUXGPQ-UHFFFAOYSA-N Methylglyoxal Chemical compound CC(=O)C=O AIJULSRZWUXGPQ-UHFFFAOYSA-N 0.000 description 1
- 208000036142 Viral infection Diseases 0.000 description 1
- 241000219094 Vitaceae Species 0.000 description 1
- IKHGUXGNUITLKF-XPULMUKRSA-N acetaldehyde Chemical compound [14CH]([14CH3])=O IKHGUXGNUITLKF-XPULMUKRSA-N 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- 150000001299 aldehydes Chemical class 0.000 description 1
- 230000008901 benefit Effects 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 230000017531 blood circulation Effects 0.000 description 1
- 239000003610 charcoal Substances 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 238000004925 denaturation Methods 0.000 description 1
- 230000036425 denaturation Effects 0.000 description 1
- 238000000151 deposition Methods 0.000 description 1
- 238000004090 dissolution Methods 0.000 description 1
- 239000003792 electrolyte Substances 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 230000007613 environmental effect Effects 0.000 description 1
- 230000003628 erosive effect Effects 0.000 description 1
- 238000011156 evaluation Methods 0.000 description 1
- 239000000835 fiber Substances 0.000 description 1
- 238000011049 filling Methods 0.000 description 1
- 235000021021 grapes Nutrition 0.000 description 1
- 238000005286 illumination Methods 0.000 description 1
- 230000001900 immune effect Effects 0.000 description 1
- 230000036512 infertility Effects 0.000 description 1
- 238000002372 labelling Methods 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 230000001071 malnutrition Effects 0.000 description 1
- 235000000824 malnutrition Nutrition 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- OKKJLVBELUTLKV-UHFFFAOYSA-N methanol Natural products OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 description 1
- WSFSSNUMVMOOMR-NJFSPNSNSA-N methanone Chemical compound O=[14CH2] WSFSSNUMVMOOMR-NJFSPNSNSA-N 0.000 description 1
- 244000005700 microbiome Species 0.000 description 1
- 230000001473 noxious effect Effects 0.000 description 1
- 102000039446 nucleic acids Human genes 0.000 description 1
- 108020004707 nucleic acids Proteins 0.000 description 1
- 150000007523 nucleic acids Chemical class 0.000 description 1
- 208000015380 nutritional deficiency disease Diseases 0.000 description 1
- 230000003287 optical effect Effects 0.000 description 1
- 230000003204 osmotic effect Effects 0.000 description 1
- 238000004806 packaging method and process Methods 0.000 description 1
- 238000012856 packing Methods 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- FGCSIJPPCNCQJB-FAOVPRGRSA-M sodium;(2r,3s,4r,5r)-2,3,4,5,6-pentahydroxyhexanal;chloride Chemical compound [Na+].[Cl-].OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C=O FGCSIJPPCNCQJB-FAOVPRGRSA-M 0.000 description 1
- 239000013589 supplement Substances 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 230000001988 toxicity Effects 0.000 description 1
- 231100000419 toxicity Toxicity 0.000 description 1
Classifications
-
- 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
- A61K33/14—Alkali metal chlorides; Alkaline earth metal chlorides
-
- 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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7004—Monosaccharides having only carbon, hydrogen and oxygen atoms
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
- A61L2/0011—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using physical methods
- A61L2/0029—Radiation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
- A61L2/0011—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using physical methods
- A61L2/0029—Radiation
- A61L2/0064—Microwaves
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/02—Nutrients, e.g. vitamins, minerals
Abstract
The present invention relates to technical field of medicine, disclose a kind of method for preparing Dextrose and Sodium Chloride Inj., comprising: concentrated wiring liquid is made in the water for injection that 60-70% configuration amount is added in sodium chloride and glucose by (a)；(b) by concentrated wiring liquid addition water for injection to configuration amount, and potting is carried out, obtains encapsulating medical fluid；(c) sterilization treatment is carried out to the encapsulating medical fluid；Wherein, the sterilization treatment is irradiation and/or microwave sterilization.This method is sterilized using the Dextrose and Sodium Chloride Inj. after irradiation and/or microwave encapsulating, without the moist hear heat test of conventional raising fluid temperature, it can be thus achieved and bacterium in sodium chloride injection is killed, the reduction of sodium chloride injection clarity caused by not generating due to medical fluid boiling, the content for reducing 5 hydroxymethyl furfural in injection simultaneously, ensure that the quality of drug.
Description
Technical field
The present invention relates to technical field of medicine, and in particular to a kind of preparation method of Dextrose and Sodium Chloride Inj..
Background technique
Critical patients usually need to carry out due to various reasons fluid-supplement therapy, and critical patients wound or stress wait because
Element makes body be in high decomposing state, and malnutrition, immunologic hypofunction, resistance is caused to weaken；Glucose is that human body is main
One of origin of heat, sodium and chlorine are electrolyte important in body, extracellular fluid are primarily present in, to maintaining human normal
The capacity and osmotic pressure of blood and extracellular fluid play very important effect.
Although glucose itself without direct biology toxicity, glucose is in high-temperature sterilization and single bag long-term storage
During depositing, a large amount of virose glucose degradation products (glucose degradation can be generated
products.GDPs)；The study found that (5.5-6.5) can be significant under traditional pH value condition for glucose during heating disinfection
Increase acetaldehyde, formaldehyde, pyroracemic aldehyde, 3- deoxyfructose (3-deoxy-glucosone, 3-DG), 3,4- double deoxidation grapes
The glucose degradation products such as saccharon aldehyde -3- alkene (3,4-dideoxyglucosone-3-ene, 3,4-DGE), 5 hydroxymethyl furfural
Generation.Due to generally believing that 5 hydroxymethyl furfural (5-HMF) is the representative of glucose degradation products (GDPs), so in grape
Generally using 5 hydroxymethyl furfural (5-HMF) as evaluation index in liquid glucose body preparation.
At the same time, Dextrose and Sodium Chloride Inj. is the drug that blood circulation of human body is directly entered by injecting, matter
Amount is the important leverage of drug safety.However Dextrose and Sodium Chloride Inj. can generate small particles during storage, cause
The stability and clarity of injection reduce.
The preparation method of existing Dextrose and Sodium Chloride Inj. is dissolution of raw material, adjusts pH value, is filtering, filling and go out
Bacterium forms.And conventional sterilization method is moist heat sterilization, i.e., Dextrose and Sodium Chloride Inj. is heated under certain temperature, so that
Medical fluid boiling, under the action of vapor plus thermogenetic heat, bacterium in medical fluid is killed in realization.Caused by moist heat sterilization
Hot environment can promote the degradation reaction of glucose, promote the content of catabolite 5-HMF to increase, seriously affected medical fluid
Quality.
At the same time, at high temperature, the impulse force of medical fluid boiling makes Dextrose and Sodium Chloride Inj. encapsulate bottle plug surface
Impurity enter medical fluid or Dextrose and Sodium Chloride Inj. made to be softened with polypropylene vial, lead to the antioxygen for including in polypropylene vial
The auxiliary agents such as agent diffuse in medical fluid, eventually lead to the bad stability of Dextrose and Sodium Chloride Inj., and clarity reduces, drug
Quality reduces.
Summary of the invention
The purpose of the invention is to overcome Dextrose and Sodium Chloride Inj. clarity of the existing technology reduce, 5- hydroxyl
The problem of Dextrose and Sodium Chloride Inj. quality reduces caused by methyl furfural (5-HMF) content is high, provides a kind of glucose
The preparation method of sodium chloride injection, this method using irradiation and/or microwave to the Dextrose and Sodium Chloride Inj. after encapsulating into
Row sterilizing, without the moist hear heat test of conventional raising fluid temperature, it can realize to bacterium in sodium chloride injection
Kill, the reduction of sodium chloride injection clarity, while reducing 5- in injection caused by not generating due to medical fluid boiling
The content of hydroxymethylfurfural ensure that the quality of drug.
To achieve the goals above, the present invention provides a kind of preparation method of Dextrose and Sodium Chloride Inj., wherein described
Method the following steps are included:
(a) sodium chloride and glucose investment are stirred in the dense preparing tank of the water for injection containing 60-70% configuration amount to complete
Injection active carbon I is added in fully dissolved, stands after stirring 10-30min, filters, and concentrated wiring liquid is made；
(b) concentrated wiring liquid is transferred in dilute preparing tank, injection active carbon II is added, injection is added into dilute preparing tank
Water after stirring carries out adsorption reaction 10-60min, carries out decarbonisation, obtains medical fluid to configuration amount；Medical fluid described in sample detection
Sodium chloride and glucose content and pH value, detect qualified medical fluid and successively pass through 0.45 μm of accurate filter and 0.2 μm
Sterilizing filter filtering, carries out potting, obtains encapsulating medical fluid；
(c) it sterilizes: sterilization treatment is carried out to the encapsulating medical fluid；
It is characterized in that, the sterilization treatment is irradiation and/or microwave treatment.
Preferably, total dosage of the injection active carbon is 0.02-0.06w/v%, preferably 0.03-0.06w/v%.
Preferably, the amount ratio of the injection active carbon I and injection active carbon II is 1:2-2:1.
Preferably, the pH value of the medical fluid is 4.7-5.5.
Preferably, the time of the irradiation sterilization processing is 10-40min, dose of radiation 20-70kGy；It is highly preferred that
The time of the irradiation sterilization processing is 20-30min, dose of radiation 40-60kGy.
Preferably, radiation sterilization processing radiation source used be in gamma-rays, high-power electron beam and X-ray at least
It is a kind of.
Preferably, when the microwave sterilization is handled, microwave power 1000MHz-3000MHz, microwave treatment temperature is 40-
80 DEG C, microwave treatment time 10-30min；Preferably, microwave power 1500MHz-2500MHz, microwave treatment temperature are
50-70 DEG C, microwave treatment time 15-25min.
Preferably, the step (c) further includes that the encapsulating medical fluid is placed in high pressure water-bath type before the sterilization treatment
Bacteria removing is carried out in sterilizing cabinet.
Preferably, the temperature of high pressure water-bath type sterilizing cabinet is 70-90 DEG C, and time of bacteria removing is 3-10min, at degerming
The pressure of reason is 5-20MPa.
It is highly preferred that the temperature of the water-bath type sterilizing cabinet is 100 DEG C, the time of bacteria removing is 5min, bacteria removing
Pressure be 10MPa.
Dextrose and Sodium Chloride Inj. provided by the invention has the advantage that
(1) present invention carries out sterilization treatment to Dextrose and Sodium Chloride Inj. using irradiation and/or microwave, avoids tradition
The impurity on the encapsulation of injection caused by being boiled in moist heat sterilization treatment process due to medical fluid bottle plug surface is entered medical fluid and caused
Dextrose and Sodium Chloride Inj. becomes cloudy, clarity reduces, and product quality reduces.
(2) present invention carries out sterilization treatment to Dextrose and Sodium Chloride Inj. using irradiation and/or microwave, avoids tradition
The injection encapsulation as caused by high temperature is softened with polypropylene vial in moist heat sterilization treatment process, cause include in polypropylene vial
The auxiliary agents such as antioxidant diffuse in medical fluid, eventually lead to sodium chloride injection become cloudy, clarity reduce, product quality drop
It is low.
(3) sterilization treatment is carried out to Dextrose and Sodium Chloride Inj. using irradiation and/or microwave in the present invention, avoids and goes out
Due to the aggravation that glucose degradation reacts caused by heating up in bacterium treatment process, catabolite 5-HMF's increases, and improves Portugal
The product quality of grape sugar sodium chloride injection.
(4) present invention sterilizes to Dextrose and Sodium Chloride Inj. using radiation mode, can not only obtain with excellent
The Dextrose and Sodium Chloride Inj. of different stability and clarity, while there is more excellent sterilization effect.
Specific embodiment
The endpoint of disclosed range and any value are not limited to the accurate range or value herein, these ranges or
Value should be understood as comprising the value close to these ranges or value.For numberical range, between the endpoint value of each range, respectively
It can be combined with each other between the endpoint value of a range and individual point value, and individually between point value and obtain one or more
New numberical range, these numberical ranges should be considered as specific open herein.
The present invention provides a kind of preparation method of Dextrose and Sodium Chloride Inj., wherein the described method comprises the following steps:
(a) sodium chloride and glucose investment are stirred in the dense preparing tank of the water for injection containing 60-70% configuration amount to complete
Injection active carbon I is added in fully dissolved, stands after stirring 10-30min, filters, and concentrated wiring liquid is made；
(b) concentrated wiring liquid is transferred in dilute preparing tank, injection active carbon II is added, injection is added into dilute preparing tank
Water after stirring carries out adsorption reaction 10-60min, and carries out decarbonisation, obtains medical fluid to configuration amount；Medicine described in sample detection
The sodium chloride and glucose content and pH value of liquid detect qualified medical fluid and successively pass through 0.45 μm of accurate filter and 0.2 μ
After m sterilizing filter is filtered, potting is carried out, encapsulating medical fluid is obtained；
(c) it sterilizes: sterilization treatment is carried out to the medical fluid after encapsulating；
It is characterized in that, the sterilization treatment is irradiation and/or microwave sterilization.
Method provided by the invention can become cloudy to avoid sodium chloride injection existing for conventional wet heat sterilization treatment process,
The defect that clarity reduces, product quality reduces.Sodium chloride injection process for preparation may include that conventional (1) weighs；(2) dense
Match；(3) dilute to match encapsulating；(4) it sterilizes；(5) lamp inspection；(6) packaging, storage step.Wherein, it may include precise that (1), which weighs,
Raw material；(2) concentrated compounding may include that concentrated wiring liquid is made；(3) dilute with encapsulating may include being made dilute with liquid and being potted；(4) it goes out
Bacterium may include that the dilute of encapsulating is carried out non-moist heat sterilization processing with liquid；(5) lamp inspection may include being placed in the product after sterilizing
It checks in product on lamp inspection station and suspends with the presence or absence of visible foreign matters；(6) packing, being put in storage may include to lamp inspection qualified products
Labelling, vanning storage.
According to the present invention, step (a) and (b) are respectively completed concentrated compounding and dilute with encapsulating, wherein it is living that injection is added in two steps
Property charcoal, the processing of adsorption-edulcoration twice is carried out to medical fluid, can be significantly reduced due to impurity bring white point, white piece in injection
And phenomena such as muddy；The dosage for further limiting respective injection active carbon in two steps can significantly improve finished product injection
The clarity of liquid, improves the quality of product, and is conducive to that radiation sterilization processing is cooperated to obtain better sterilization effect.
According to the present invention, total dosage of the injection active carbon is 0.02-0.06w/v%, preferably 0.03-0.06w/
V%.
According to the present invention, the amount ratio of the injection active carbon I and injection active carbon II is 1:2-2:1.
In the present invention, injection active carbon I and injection active carbon II can be identical or different, respectively can be various cities
Sell for the active carbon that pharmaceutically uses.
According to the present invention, final sodium chloride injection obtained meets requirement, it is preferable that in injection, is based on institute
The total amount of medical fluid is stated, the content of the sodium chloride is 0.85wt%-0.95wt%, and the content of glucose is 1.0wt%-
8.0wt%, the pH value of the medical fluid are 4.7-5.5；Preferably, the content of the sodium chloride is 0.9wt%, the glucose
Content is 5.0wt%, and the pH value of the medical fluid is 5.0-5.2.
It, can be from the stability for guaranteeing Dextrose and Sodium Chloride Inj. using pH value defined by the present invention in the present invention
While, due to the H in glucose saline during preventing injection from storing for a long time+、Cl-Deng to container glass bottle
The precipitating for corroding and generating enters in injection, so that the clarity of injection reduces.
At the same time, " Chinese Pharmacopoeia " is met to Dextrose and Sodium Chloride Inj. pH value using the limited pH value of the present invention
Regulation, and in the pH value defined by the present invention, 5 hydroxymethyl furfural (5-HMF) content generated by glucose degradation is minimum.
According to the present invention, the condition of irradiation sterilization processing is preferably, comprising: the time of the irradiation sterilization processing is
10-40min, dose of radiation 20-70kGy；Preferably, the time of the irradiation sterilization processing is 20-30min, dose of radiation
For 40-60kGy.
The condition of the microwave sterilization processing is preferably, comprising: microwave power 1000MHz-3000MHz, microwave treatment
Temperature is 40-80 DEG C, microwave treatment time 10-30min；Preferably, microwave power 1500MHz-2500MHz, at microwave
Managing temperature is 50-70 DEG C, microwave treatment time 15-25min.
In the present invention, sterilization treatment is carried out to Dextrose and Sodium Chloride Inj. using radiation and/or microwave.Wherein, it radiates
Sterilizing has the characteristics that penetrability is strong, and its temperature that raising product is not needed in sterilization process.And microwave is a kind of high
Frequency electromagnetic waves, the Electromagnetic Environmental Effect generated, quantum effect and superconduction effect etc. can make protein, nucleic acid in microorganism
Equal molecules reversing, causes the rotation and vibration of micel, makes protein denaturation and then realizes the effect of sterilizing.And it is opposite
In traditional moist heat sterilization mode, microwave sterilization can realize the effect for killing bacterium under more lower temperature.
During being sterilized using irradiation and/or microwave to Dextrose and Sodium Chloride Inj. in the present invention, medical fluid is not
Can boil, reduce due in medical fluid boiling process to injection bottle and rubber plug wash away cause to introduce in medical fluid it is miscellaneous
Matter improves the clarity of injection finished product.
For injection polypropylene vial, high temperature can make polypropylene soften, so that including in polypropylene
The auxiliary agents such as antioxidant diffuse in injection, and injection is caused to become cloudy, and the stability and clarity of product reduce.And this
In invention, sterilization treatment is carried out to Dextrose and Sodium Chloride Inj. using radiation mode, due to product temperature in sterilisation process
Degree does not increase, and can significantly reduce due to injection clarity reduction ground phenomenon caused by softening under polypropylene vial high temperature, mention
The high quality of product.
At the same time, since in sterilization process, the temperature of Dextrose and Sodium Chloride Inj. is lower, grape can be significantly reduced
The degradation speed of sugar, and then the generation of noxious material 5 hydroxymethyl furfural (5-HMF) is reduced, product quality is provided.
In the present invention, in order to guarantee the sterilization effect of Dextrose and Sodium Chloride Inj., inventor is to irradiation and microwave sterilization
Condition studied, the study found that can either be protected using radiation parameter defined by the present invention or when microwave treatment conditions
The sterilization effect of Dextrose and Sodium Chloride Inj. is demonstrate,proved, while reducing the degradation rate of sterilization process glucose, reduces 5- methylol
The generation of furfural (5-HMF), and the injection product with excellent stability and clarity can be obtained.
In accordance with the present invention it is preferred that radiation source used in the radiation sterilization processing is preferably gamma-rays, high-power electron beam
At least one of with X-ray.
In the present invention, in order to further increase sterilization effect, it is ensured that the aseptic of Dextrose and Sodium Chloride Inj., preferably
Before carrying out sterilization treatment, Dextrose and Sodium Chloride Inj. medical fluid is placed in high pressure water-bath type sterilizing cabinet and carries out bacteria removing.
And cooperate the radiation sterilization of the invention used, the temperature of water-bath type sterilizing cabinet and time can be all made of and compare in the present invention
Lower in temperature in the prior art, time shorter setting reduces the processing of prior art moist heat sterilization high temperature to glucose chlorine
Change the influence of sodium injection clarity and stability.
In accordance with the present invention it is preferred that the step (c) further includes setting the encapsulating medical fluid before the sterilization treatment
Bacteria removing is carried out in high pressure water-bath type sterilizing cabinet.
In accordance with the present invention it is preferred that the temperature of the water-bath type sterilizing cabinet is 80-110 DEG C, the bacteria removing time is 3-
10min, bacteria removing pressure are 5-20MPa.
In accordance with the present invention it is preferred that the temperature of the water-bath type sterilizing cabinet is 100 DEG C, the time of bacteria removing is 5min,
The pressure of bacteria removing is 10MPa.
The present invention will be described in detail by way of examples below.In following embodiment:
Stability: the technical requirements that medicine stability is investigated according to " Chinese Pharmacopoeia ", investigate temperature at 40 DEG C ± 2 DEG C,
Relative humidity is sampled at initial 0 month of test, January, March, June, September and December respectively under 25% ± 5% acceleration environment
The stability of Dextrose and Sodium Chloride Inj. is investigated in measurement, and testing result is shown in Table 1.
Clarity detection: detection method according to " clarity test detailed rules and regulations and judgment criteria " regulation inspection.Specifically, adopting
With fluorescent lamp, in the position that intensity of illumination is 1000-1500Ix, using canopy type device, background is non-reflective, test sample to people
Eye distance is being protected from light indoor or in the dark carried out when inspection from for 20-25cm.Test sample is extracted 200, is cleaned outside ampoule bottle
Wall stains, are centrally placed.It takes 40 and operates continuously when detection, in outside umbrella canopy edge, hand-held ampoule bottle neck makes medical fluid gently
Whether overturning, inspecting has the foreign matters such as macroscopic vitroclastic, white point, fiber.Detection Dextrose and Sodium Chloride Inj. is 0 respectively
The moon, January, March, June, September and the clarity in December, testing result are shown in Table 1.
Aseptic: temperature is investigated at 40 DEG C ± 2 DEG C according to " Chinese Pharmacopoeia " annex XI H Sterility Test, relative humidity exists
Under 25% ± 5% acceleration environment, it is measured by sampling at 0 month, January, March, June, September and December investigates glucose chlorination respectively
The aseptic of sodium injection, testing result are shown in Table 1.
PH value: being measured using acidometer, and testing result is shown in Table 1.
The content of 5-HMF: 0 month is measured respectively using Optical Rotation, January, March, June, September and being measured by sampling when December examine
The content of 5-HMF in Dextrose and Sodium Chloride Inj. is examined, testing result is shown in Table 1.
In following embodiment and comparative example, the injection active carbon I and injection active carbon II are in this field
Conventional injection active carbon, wherein I and II is only to show injection active carbon in two times in the asynchronous of the method
It is added in rapid.
Embodiment 1
(1) precise raw material；
(2) water for injection and sodium chloride and glucose of 70% configuration amount are added in dense preparing tank, stirring is to completely molten
Injection active carbon I is added in solution, stands after stirring 30min, filters, and concentrated wiring liquid is made；
(3) concentrated wiring liquid is transferred in dilute preparing tank, injection active carbon II is added, injection is added into dilute preparing tank
Water is to configuration amount, after stirring carries out adsorption reaction 30min, carries out decarbonisation, and sample detection sodium chloride and glucose contain
The pH of amount and medical fluid detects qualified medical fluid and successively passes through 0.45 μm of accurate filter and 0.2 μm of sterilizing filter filtering, into
Row potting.Wherein, total dosage of injection active carbon is 0.06w/v%, the use of injection active carbon I and injection active carbon II
Amount is than being 1:1, and the content of sodium chloride is 0.9wt%, and the content of glucose sugar is 5wt%.
(4) sterilization treatment, irradiation time 10min are carried out to the medical fluid after encapsulating using irradiation, dose of radiation is
70kGy, radiation source are gamma-rays.
(5) product after sterilizing is placed on lamp inspection station and is checked in product with the presence or absence of visible foreign matters suspension；
(6) it labels to lamp inspection qualified products, vanning storage.
Embodiment 2
(1) precise raw material；
(2) water for injection and sodium chloride and glucose of 60% configuration amount are added in dense preparing tank, stirring is to completely molten
Injection active carbon I is added in solution, stands after stirring 10min, filters, and concentrated wiring liquid is made；
(3) concentrated wiring liquid is transferred in dilute preparing tank, injection active carbon II is added, injection is added into dilute preparing tank
Water after stirring carries out adsorption reaction 40min, carries out decarbonisation, the content and medical fluid of sample detection sodium chloride to configuration amount
PH, detect qualified medical fluid and successively pass through 0.45 μm of accurate filter and 0.2 μm of sterilizing filter filtering, carry out potting.Its
In, total dosage of injection active carbon is that the amount ratio of 0.02w/v%, injection active carbon I and injection active carbon II are 1:
2, the content of sodium chloride is 0.9wt%, and the content of glucose is 5wt%.
(4) sterilization treatment, irradiation time 40min are carried out to the medical fluid after encapsulating using irradiation, dose of radiation is
20kGy, radiation source are high-power electron beam.
(5) product after sterilizing is placed on lamp inspection station and is checked in product with the presence or absence of visible foreign matters suspension；
(6) it labels to lamp inspection qualified products, vanning storage.
Embodiment 3
Dextrose and Sodium Chloride Inj. is prepared using method same as Example 1, unlike: irradiation time is
25min, dose of radiation 50kGy.
Embodiment 4
Dextrose and Sodium Chloride Inj. is prepared using method same as Example 1, unlike: it is used in step (4)
Microwave carries out sterilization treatment, microwave power 1000MHz to the medical fluid after encapsulating, and microwave treatment temperature is 80 DEG C, microwave treatment
Time is 30min.
Embodiment 5
Dextrose and Sodium Chloride Inj. is prepared using method same as Example 1, unlike: it is used in step (4)
Microwave carries out sterilization treatment, microwave power 3000MHz to the medical fluid after encapsulating, and microwave treatment temperature is 40 DEG C, microwave treatment
Time is 10min.
Embodiment 6
Dextrose and Sodium Chloride Inj. is prepared using method same as Example 1, unlike: it is used in step (4)
Microwave carries out sterilization treatment, microwave power 2500MHz to the medical fluid after encapsulating, and microwave treatment temperature is 65 DEG C, microwave treatment
Time is 14min.
Embodiment 7
Dextrose and Sodium Chloride Inj. is prepared using method same as Example 1, unlike: in step (4) simultaneously
Sterilization treatment is carried out to the medical fluid after encapsulating using irradiation and microwave, wherein the condition of microwave sterilization processing are as follows: microwave power is
3000MHz, microwave treatment temperature are 40 DEG C, microwave treatment time 10min.
Embodiment 8
Dextrose and Sodium Chloride Inj. is prepared using method same as Example 7, unlike: step (4) further includes
Medical fluid before sterilization treatment is placed in high pressure water-bath type sterilizing cabinet and carries out degerming, the temperature of sterilizing cabinet is 100 DEG C, degerming time
For 5min, degerming pressure is 10MPa.
Comparative example 1
Dextrose and Sodium Chloride Inj. is prepared using method same as Example 2, unlike: using traditional damp and hot
Method carries out sterilization treatment to injection, and the temperature of sterilization treatment is 121 DEG C, sterilization time 15min.
Comparative example 2
Dextrose and Sodium Chloride Inj. is prepared using method same as Example 1, unlike: irradiation sterilization processing
Time is 8min.
Comparative example 3
Dextrose and Sodium Chloride Inj. is prepared using method same as Example 1, unlike: irradiation sterilization processing
Dose of radiation is 18kGy.
Comparative example 4
Dextrose and Sodium Chloride Inj. is prepared using method same as Example 4, unlike: microwave power is
914MHz。
Comparative example 5
Dextrose and Sodium Chloride Inj. is prepared using method same as Example 4, unlike: microwave treatment time is
9min。
Comparative example 6
Dextrose and Sodium Chloride Inj. is prepared using method same as Example 2, unlike: injection active carbon exists
Step is once added in (3).
Comparative example 7
Dextrose and Sodium Chloride Inj. is prepared using method same as Example 1, unlike: injection active carbon I
Usage ratio with injection active carbon II is 3:2.
Comparative example 8
Dextrose and Sodium Chloride Inj. is prepared using method same as Example 8, unlike: sterilising temp 121
DEG C, sterilization time 15min, sterilization pressure 1MPa.
Comparative example 9
Dextrose and Sodium Chloride Inj. is prepared using method same as Example 7, unlike: the pH value of medical fluid is not fallen
Enter in limited range of the present invention.
1 embodiment 1- comparative example of table, 9 test result
It can be seen that the preparation-obtained glucose chlorination of embodiment 1-8 using the method for the present invention by the result of table 1
Sodium injection is under the conditions of Acceleration study, and colourless clear liquid state is presented in the 0-12 middle of the month, injection appearance, and has
Good clarity has and meets defined pH.At the same time, through detecting, the Dextrose and Sodium Chloride Inj. was at 12 months
It is inside generated without bacterium, there is good aseptic, and glucose degradation products 5-HMF contains in Dextrose and Sodium Chloride Inj.
It measures relatively low.
In the embodiment 7 combined using irradiation sterilization with microwave sterilization, preparation-obtained glucose sodium chloride injection
Stability, clarity, the aseptic of liquid make moderate progress, and since the 5-HMF content that glucose sugar is degraded and generated also significantly drops
It is low.
It, can be in the embodiment 8 combined using irradiation sterilization, microwave sterilization and high pressure water-bath type sterilizing three
While guaranteeing Dextrose and Sodium Chloride Inj. stability and clarity, more excellent aseptic is obtained, at the same time, by
It is relatively low in the 5-HMF content that glucose degradation generates.
And only in the comparative example of water-bath type sterilizing mode 1, used high temperature when due to sterilizing makes more impurity
It is introduced into Dextrose and Sodium Chloride Inj., and accelerates glucose degradation reaction, cause Dextrose and Sodium Chloride Inj. at 3 months
When start to turn yellow, and gradually appear precipitating, the stability and clarity of Dextrose and Sodium Chloride Inj. are substantially reduced, Portugal
The content of grape sugar catabolite 5-HMF increases significantly.
Using the comparative example 2 compared with the short irradiation time and using the comparative example 3 compared with low radiation dose, although the grape of its acquisition
Sugared sodium chloride injection shows good stability and clarity in 12 months, however since irradiation time is short or radiation
Dosage is low, cause in Dextrose and Sodium Chloride Inj. bacterium to kill degree inadequate, cause it when carrying out sterile test,
Start within 1 month, culture medium occurs as soon as turbid phenomenon, and starts at 3rd month, bacterium occurs in culture medium.
Comparative example 4 using lower microwave power and the comparative example 5 using shorter microwave, although the glucose chlorine of its acquisition
Change sodium injection and shows good stability and clarity in 12 months, however since the microwave time is short or microwave power
It is low, cause in Dextrose and Sodium Chloride Inj. bacterium to kill degree inadequate, cause it when carrying out sterile test, the 1st
The moon starts, and culture medium occurs as soon as turbid phenomenon, and starts at 3rd month, bacterium occurs in culture medium.
The comparative example 6 and injection active carbon I being once added using injection active carbon are with injection active carbon II's
Usage ratio does not fall within the comparative example 7 in limited range of the present invention, and Dextrose and Sodium Chloride Inj. matches potting process dilute
In by the impurity etc. that raw material and container itself are brought into be not tightly held by activated carbon processing thoroughly, lead to the glucose finally obtained
The stability and clarity of sodium chloride injection are poor.
And use higher temperature, the high pressure water-bath type sterilization method and irradiation sterilization of long period and lower pressure and micro-
The comparative example 8 that wave sterilization method combines, although when water-bath type sterilizing, higher temperature and longer time can sufficiently go out
The bacterium in injection is killed, but introduces injection since high temperature leads to the boiling of medical fluid or softens injection polypropylene vial
Impurity content in liquid increases, and high temperature promotes the generation of glucose degradation reaction, eventually leads to the stability of injection
And clarity reduces, the content of 5-HMF significantly increases.
And the pH of Dextrose and Sodium Chloride Inj. does not fall within the comparative example 9 in limited range of the present invention, due to injection
H in liquid+The presence of ion, the precipitating erosion of container glass bottle generated during injection is stored for a long time due to it into
Enter in injection, so that the clarity of injection reduces.And H in injection+The presence of ion promotes glucose drop
The generation for solving reaction, causes the content of 5-HMF in injection to significantly increase.
The preferred embodiment of the present invention has been described above in detail, and still, the present invention is not limited thereto.In skill of the invention
In art conception range, can with various simple variants of the technical solution of the present invention are made, including each technical characteristic with it is any its
Its suitable method is combined, and it should also be regarded as the disclosure of the present invention for these simple variants and combination, is belonged to
Protection scope of the present invention.
Claims (10)
1. a kind of method for preparing Dextrose and Sodium Chloride Inj., wherein the described method comprises the following steps:
(a) sodium chloride and glucose investment are stirred in the dense preparing tank of the water for injection containing 60-70% configuration amount to completely molten
Injection active carbon I is added in solution, stands after stirring 10-30min, filters, and concentrated wiring liquid is made；
(b) concentrated wiring liquid is transferred in dilute preparing tank, injection active carbon II is added, water for injection is added extremely into dilute preparing tank
Configuration amount after stirring carries out adsorption reaction 10-60min, carries out decarbonisation, obtains medical fluid；The chlorine of medical fluid described in sample detection
Change sodium and glucose content and pH value, detects qualified medical fluid and successively pass through 0.45 μm of accurate filter and 0.2 μm of degerming
After filter is filtered, potting is carried out, encapsulating medical fluid is obtained；
(c) sterilization treatment is carried out to the encapsulating medical fluid；
It is characterized in that, the sterilization treatment is irradiation and/or microwave sterilization.
2. the method described in any one of according to claim 1, wherein the time of the irradiation sterilization processing is 10-
40min, dose of radiation 20-70kGy；Preferably, the time of the irradiation sterilization processing is 20-30min, and dose of radiation is
40-60kGy。
3. according to claim 1 or method described in any one of 2, wherein radiation sterilization processing radiation source used
For at least one of gamma-rays, high-power electron beam and X-ray.
4. method described in any one of -3 according to claim 1, wherein when microwave sterilization processing, microwave power is
1000MHz-3000MHz, microwave treatment temperature are 40-80 DEG C, microwave treatment time 10-30min；Preferably, microwave power
For 1500MHz-2500MHz, microwave treatment temperature is 50-70 DEG C, microwave treatment time 15-25min.
5. method described in any one of -4 according to claim 1, wherein total dosage of the injection active carbon is
0.02-0.06w/v%, preferably 0.03-0.06w/v%.
6. method described in any one of -5 according to claim 1, wherein the injection active carbon I and the injection
The amount ratio of active carbon II is 1:2-2:1.
7. method described in -6 according to claim 1, wherein the pH value of the medical fluid is 4.7-5.5.
8. method according to any one of claims 1-7, wherein the step (c) further includes at the sterilizing
Before reason, the encapsulating medical fluid is placed in high pressure water-bath type sterilizing cabinet and carries out bacteria removing.
9. according to the method described in claim 8, wherein, the temperature of the high pressure water-bath type sterilizing cabinet is 70-90 DEG C, at degerming
The time of reason is 3-10min, and the pressure of bacteria removing is 5-20MPa.
10. method according to claim 8 or claim 9, wherein the temperature of the water-bath type sterilizing cabinet is 80 DEG C, bacteria removing
Time be 5min, the pressure of bacteria removing is 10MPa.
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| CN1799551A (en) * | 2005-08-12 | 2006-07-12 | 樊武良 | Process for preparing glucose injection and glucose sodium chloride injection |
| CN105168126A (en) * | 2015-10-23 | 2015-12-23 | 广西裕源药业有限公司 | Production process of glucose injections filled in plastic bottles |
| CN106309482A (en) * | 2016-08-23 | 2017-01-11 | 华仁药业股份有限公司 | Process for preparing glucose and sodium chloride injection. |
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