CN106176595A - A kind of ganciclovir injection and preparation technology thereof - Google Patents
A kind of ganciclovir injection and preparation technology thereof Download PDFInfo
- Publication number
- CN106176595A CN106176595A CN201610792340.1A CN201610792340A CN106176595A CN 106176595 A CN106176595 A CN 106176595A CN 201610792340 A CN201610792340 A CN 201610792340A CN 106176595 A CN106176595 A CN 106176595A
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- Prior art keywords
- ganciclovir
- injection
- sodium
- ganciclovir injection
- water
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
- A61K31/52—Purines, e.g. adenine
- A61K31/522—Purines, e.g. adenine having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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- Health & Medical Sciences (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Dermatology (AREA)
- Hematology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention belongs to field of medicine preparing technology, it particularly relates to a kind of ganciclovir injection and preparation technology thereof.Described ganciclovir injection includes ganciclovir and pH adjusting agent；Described ganciclovir injection, with water for injection as solvent, take plastic ampoule as the inner container directly contacting ganciclovir injection.Carry out in depth analyzing and researching by the mechanism that turbidity and precipitation easily occurs ganciclovir injection, have found the essential reason easily occurring that visible foreign matters is defective, particulate matter increases.Compared with prior art, packaged with plastic container material is selected by ganciclovir injection of the present invention in the preparation, makes medicinal liquid and packaging material all present the good compatibility, so that visible foreign matters and particulate matter are all remarkably decreased.
Description
Technical field
The invention belongs to field of medicine preparing technology, it particularly relates to a kind of ganciclovir injection and preparation thereof
Technique.
Background technology
Ganciclovir is the 2nd generation ucleosides antiviral agents of syntex drugmaker of Britain exploitation.After this medicine enters cell
By virus kinases inductive formation triphosphoric acid compound, competitive inhibition virus archaeal dna polymerase and terminate viral DNA chain increase.
Deepening continuously recently as clinical practice, ganciclovir is used widely in various diseases.But in ganciclovir water
Dissolubility is poor, is slightly soluble in water, but increases along with pH value increases dissolubility, and the ganciclovir injection pH value of listing is at present
Between 10.5～11.5, glass ampule contains.But glass ampule often causes glass flake particularly at the medicinal liquid accommodated
The problem that its alkalescence thin slice dissolves.First glass ampule needs to break disconnected ampoule in use, because of the fragility of glass, makes breaking disconnected peace
A large amount of glass chip taken out of by small jar simultaneously, makes glass chip be directly entered in medicine, and it is more than 50 microns that microgranule is differentiated by human eye, because of
Human capillary vessel's diameter only has 7 microns, and a large amount of not visible glass granules input human body with medicine, have " invisible micro-
Grain pollutes " Weihai, and the harm of this microgranule has potentiality and persistency.
Summary of the invention
For solving above-mentioned technical problem, the invention provides one and visible foreign matters can be delayed defective and particulate matter increasing
The ganciclovir injection added and preparation technology thereof.
A kind of ganciclovir injection of the present invention, described ganciclovir injection includes ganciclovir and pH regulator
Agent；Described ganciclovir injection, with water for injection as solvent, is directly to contact in ganciclovir injection with plastic ampoule
Packing container.
A kind of ganciclovir injection of the present invention, described pH adjusting agent is selected from sodium hydroxide, sodium bicarbonate, carbonic acid
One or many in sodium, sodium citrate, potassium citrate, sodium citrate, sodium lactate, sodium phosphate, dibastic sodium phosphate or sodium dihydrogen phosphate
Kind.
A kind of ganciclovir injection of the present invention, the material of described plastic ampoule selected from polyethylene (PE) plastics,
Polyester (PET and PBT) plastics, polypropylene (PP) plastics or the one of polrvinyl chloride (PVC) plastics.
A kind of ganciclovir injection of the present invention, the material of described plastic ampoule is selected from polypropylene plastics；Described
PH adjusting agent is sodium hydroxide.
A kind of ganciclovir injection of the present invention, described ganciclovir injection specification is every 5ml, containing more former times
Lip river Wei 0.25g.
A kind of ganciclovir injection of the present invention, described ganciclovir injection also includes that Herba Leonuri folds olefin(e) acid ester
A。
The preparation technology of ganciclovir injection of the present invention, described preparation technology concretely comprises the following steps: 1) injection
The lower sodium hydroxide adding 1/10 ganciclovir amount of water stirring, is stirred to dissolve, is slowly poured into by the ganciclovir of recipe quantity, stir
Mix and make to be completely dissolved；With sodium hydroxide regulation pH value to 11.2；2) activated carbon adding 0.3% (w/v) stirs 10 minutes, is not added with
Water for injection, to full dose, filtration cycle 15 minutes, after sampling detection level, pH value are qualified, is pacified with three-in-one device plastics PP
Small jar, fill, sealing；In 115 DEG C of sterilizings 30 minutes, packaging after lamp inspection is qualified, inspection.
Carry out in depth analyzing and researching by the mechanism that turbidity and precipitation easily occurs ganciclovir injection, have found easily
The essential reason that appearance visible foreign matters is defective, particulate matter increases.Ganciclovir injection occur visible foreign matters defective,
The essential reason that particulate matter increases is: when containing ganciclovir injection with glass ampule, owing to ganciclovir is injected
Liquid is alkaline solution, under the conditions of high temperature sterilize or in storage, and medicinal liquid often attack glass, cause glass flake special
It not that its alkalescence thin slice dissolves, cause that visible foreign matters is defective, particulate matter is gradually increased.Then, from directly contacting medicinal liquid
Inner packaging material start with that to solve the technology that ganciclovir injection occurs that visible foreign matters is defective, particulate matter increases difficult
Topic.Compared with prior art, packaged with plastic container material is selected by ganciclovir injection of the present invention in the preparation,
Medicinal liquid and packaging material is made all to present the good compatibility, so that visible foreign matters and particulate matter are all remarkably decreased.
Detailed description of the invention
Below in conjunction with specific embodiment, ganciclovir injection of the present invention and preparation technology thereof are done furtherly
Bright, but protection scope of the present invention is not limited to this.
Embodiment 1
Prescription:
Technical process:
Its preparation method is:
(1) the lower sodium hydroxide adding 1/10 ganciclovir amount of water for injection stirring, is stirred to dissolve, by recipe quantity more
VCV is slowly poured into, and stirring makes to be completely dissolved.With sodium hydroxide regulation pH value to 11.2.
(2) activated carbon adding 0.3% (w/v) stirs 10 minutes, does not adds to the full amount of water for injection, filtration cycle 15 points
Clock, after sampling detection level, pH value are qualified, with three-in-one device plastics PP ampoule, fill, sealing.In 115 DEG C of sterilizings 30 points
Clock.Packaging after lamp inspection is qualified, inspection.
Embodiment 2
Prescription:
Its preparation method is:
(1) the lower sodium hydroxide adding recipe quantity of water for injection stirring, is stirred to dissolve, by slow for the ganciclovir of recipe quantity
Slowly pouring into, stirring makes to be completely dissolved.With sodium carbonate regulation pH value to 11.2.
(2) activated carbon adding 0.3% (w/v) stirs 10 minutes, does not adds to the full amount of water for injection, filtration cycle 15 points
Clock, after sampling detection level, pH value are qualified, with three-in-one device plastics PP ampoule, fill, sealing.In 115 DEG C of sterilizings 30 points
Clock.Packaging after lamp inspection is qualified, inspection.
Embodiment 3
Prescription:
Its preparation method is:
(1) the lower sodium hydroxide adding recipe quantity of water for injection stirring, is stirred to dissolve, by the ganciclovir of recipe quantity and
Herba Leonuri is folded olefin(e) acid ester A and is slowly poured into, and stirring makes to be completely dissolved.With sodium carbonate regulation pH value to 11.2.
(2) activated carbon adding 0.3% (w/v) stirs 10 minutes, does not adds to the full amount of water for injection, filtration cycle 15 points
Clock, after sampling detection level, pH value are qualified, with three-in-one device plastics PP ampoule, fill, sealing.In 115 DEG C of sterilizings 30 points
Clock.Packaging after lamp inspection is qualified, inspection.
Comparative examples
Prescription:
(1) the lower sodium hydroxide adding 1/10 ganciclovir amount of water for injection stirring, is stirred to dissolve, by recipe quantity more
VCV is slowly poured into, and stirring makes to be completely dissolved.With sodium hydroxide regulation pH value to 11.2.
(2) activated carbon adding 0.3% (w/v) stirs 10 minutes, does not adds to the full amount of water for injection, filtration cycle 15 points
Clock, after sampling detection level, pH value are qualified, embedding was in the glass ampule that common process is cleaned, in 115 DEG C of sterilizings 30 minutes.
Packaging after lamp inspection is qualified, inspection.
Compliance test result
Selecting visible foreign matters and particulate matter is that the present invention is explained in further detail by index.Detection method reference
Current version pharmacopeia annex visible foreign matters and particulate determination method.Example 1～3 and comparative examples carry out character,
The detection of pH value, visible foreign matters and particulate matter, result is as shown in table 1.
The various sample property of table 1, pH value, visible foreign matters and the measurement result of particulate matter
Claims (7)
1. a ganciclovir injection, it is characterised in that described ganciclovir injection includes ganciclovir and pH adjusting agent；
Described ganciclovir injection, with water for injection as solvent, take plastic ampoule as the inner packing directly contacting ganciclovir injection
Container.
A kind of ganciclovir injection the most according to claim 1, it is characterised in that described pH adjusting agent is selected from hydroxide
Sodium, sodium bicarbonate, sodium carbonate, sodium citrate, potassium citrate, sodium citrate, sodium lactate, sodium phosphate, dibastic sodium phosphate or di(2-ethylhexyl)phosphate
One or more in hydrogen sodium.
A kind of ganciclovir injection the most according to claim 1, it is characterised in that the material of described plastic ampoule is selected from
The one of vinyon, polyester plastics, polypropylene plastics or igelite.
A kind of ganciclovir injection the most according to claim 1, it is characterised in that the material of described plastic ampoule is selected from
Polypropylene plastics；Described pH adjusting agent is sodium hydroxide.
A kind of ganciclovir injection the most according to claim 1, it is characterised in that described ganciclovir injection specification
For every 5ml, containing ganciclovir 0.25g.
A kind of ganciclovir injection the most according to claim 1, it is characterised in that described ganciclovir injection also wraps
Include Herba Leonuri and fold olefin(e) acid ester A.
The preparation technology of ganciclovir injection the most according to claim 5, it is characterised in that described preparation technology is concrete
Step is: 1) the lower sodium hydroxide adding 1/10 ganciclovir amount of water for injection stirring, is stirred to dissolve, by the more former times of recipe quantity
Luo Wei slowly pours into, and stirring makes to be completely dissolved；With sodium hydroxide regulation pH value to 11.2；2) activated carbon of 0.3% (w/v) is added
Stirring 10 minutes, benefit adds to the full amount of water for injection, filtration cycle 15 minutes, after sampling detection level, pH value are qualified, with three-in-one
Equipment plastics PP ampoule, fill, sealing；In 115 DEG C of sterilizings 30 minutes, packaging after lamp inspection is qualified, inspection.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610792340.1A CN106176595B (en) | 2016-08-31 | 2016-08-31 | A kind of ganciclovir injection and its preparation process |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610792340.1A CN106176595B (en) | 2016-08-31 | 2016-08-31 | A kind of ganciclovir injection and its preparation process |
Publications (2)
| Publication Number | Publication Date |
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| CN106176595A true CN106176595A (en) | 2016-12-07 |
| CN106176595B CN106176595B (en) | 2019-10-22 |
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| CN201610792340.1A Active CN106176595B (en) | 2016-08-31 | 2016-08-31 | A kind of ganciclovir injection and its preparation process |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110613681A (en) * | 2019-09-19 | 2019-12-27 | 湖北科益药业股份有限公司 | Ganciclovir injection and preparation process thereof |
Citations (4)
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|---|---|---|---|---|
| CN1679580A (en) * | 2005-02-01 | 2005-10-12 | 山东鲁抗辰欣药业有限公司 | Ganciclovir injection and preparation thereof |
| CN1868449A (en) * | 2006-06-14 | 2006-11-29 | 湖北科益药业股份有限公司 | Ganciclovir ophthalmic gel and its prepn. method |
| EP2436376B1 (en) * | 2007-09-28 | 2014-07-09 | BIND Therapeutics, Inc. | Cancer cell targeting using nanoparticles |
| CN104414967A (en) * | 2013-09-06 | 2015-03-18 | 康普药业股份有限公司 | Ganciclovir injection solution and preparation method thereof |
-
2016
- 2016-08-31 CN CN201610792340.1A patent/CN106176595B/en active Active
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1679580A (en) * | 2005-02-01 | 2005-10-12 | 山东鲁抗辰欣药业有限公司 | Ganciclovir injection and preparation thereof |
| CN1868449A (en) * | 2006-06-14 | 2006-11-29 | 湖北科益药业股份有限公司 | Ganciclovir ophthalmic gel and its prepn. method |
| EP2436376B1 (en) * | 2007-09-28 | 2014-07-09 | BIND Therapeutics, Inc. | Cancer cell targeting using nanoparticles |
| CN104414967A (en) * | 2013-09-06 | 2015-03-18 | 康普药业股份有限公司 | Ganciclovir injection solution and preparation method thereof |
Non-Patent Citations (3)
| Title |
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| 刘胜新主播: "《化验员手册》", 31 March 2014, 机械工业出版社 * |
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| 郑开颜等: "塑料和玻璃安瓿注射剂临床使用微粒及微生物污染的比较", 《中国现代应用药学杂志》 * |
Cited By (1)
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| CN110613681A (en) * | 2019-09-19 | 2019-12-27 | 湖北科益药业股份有限公司 | Ganciclovir injection and preparation process thereof |
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| Publication number | Publication date |
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| CN106176595B (en) | 2019-10-22 |
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