CN106176595B - A kind of ganciclovir injection and its preparation process - Google Patents
A kind of ganciclovir injection and its preparation process Download PDFInfo
- Publication number
- CN106176595B CN106176595B CN201610792340.1A CN201610792340A CN106176595B CN 106176595 B CN106176595 B CN 106176595B CN 201610792340 A CN201610792340 A CN 201610792340A CN 106176595 B CN106176595 B CN 106176595B
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- CN
- China
- Prior art keywords
- ganciclovir
- injection
- ganciclovir injection
- sodium
- foreign matters
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- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- 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
Abstract
The invention belongs to field of medicine preparing technology, it particularly relates to arrive a kind of ganciclovir injection and its preparation process.The ganciclovir injection includes Ganciclovir and pH adjusting agent；The ganciclovir injection is the inner container for directly contacting ganciclovir injection with plastic ampoule using water for injection as solvent.It is in depth analyzed and researched by easily occurring the mechanism of turbidity and precipitation to ganciclovir injection, has found and the essential reason that visible foreign matters are unqualified, particulate matter increases easily occur.Compared with prior art, ganciclovir injection of the present invention in the preparation selects packaged with plastic container material, makes medical fluid and packaging material that good compatibility be presented, so that visible foreign matters and particulate matter be made to be remarkably decreased.
Description
Technical field
The invention belongs to field of medicine preparing technology, it particularly relates to arrive a kind of ganciclovir injection and its preparation
Technique.
Background technique
Ganciclovir is the 2nd generation ucleosides antiviral agent of syntex drugmaker, Britain exploitation.After the medicine enters cell
By virus kinases inductive formation triphosphoric acid compound, the archaeal dna polymerase of Reverse transcriptase virus and terminate viral DNA chain growth.
Recently as deepening continuously for clinical application, Ganciclovir is used widely in various diseases.But in Ganciclovir water
Dissolubility is poor, is slightly soluble in water, but increase as pH value increases solubility, the ganciclovir injection pH value listed at present is
Between 10.5~11.5, glass ampule is contained.But glass ampule often causes glass flake to be especially in the medical fluid of receiving
The problem of its alkaline thin slice dissolution.Glass ampule needs to break disconnected ampoule when in use first, because of the fragility of glass, makes breaking disconnected peace
Small jar takes a large amount of glass chips out of simultaneously, is directly entered glass chip in drug, and human eye is 50 microns or more to particle resolution, because
Human capillary vessel's diameter only has 7 microns, and a large amount of not visible glass granules input human body with drug, has " invisible micro-
Grain pollution " Weihai, and the harm of this particle has potentiality and persistence.
Summary of the invention
In order to solve the above technical problems, visible foreign matters can be delayed unqualified and particulate matter increasing the present invention provides a kind of
The ganciclovir injection and its preparation process added.
A kind of ganciclovir injection of the present invention, the ganciclovir injection include that Ganciclovir and pH are adjusted
Agent；The ganciclovir injection is directly to contact in ganciclovir injection with plastic ampoule using water for injection as solvent
Packing container.
A kind of ganciclovir injection of the present invention, the pH adjusting agent are selected from sodium hydroxide, sodium bicarbonate, carbonic acid
One of sodium, sodium citrate, potassium citrate, sodium citrate, sodium lactate, sodium phosphate, dibastic sodium phosphate or sodium dihydrogen phosphate are more
Kind.
A kind of ganciclovir injection of the present invention, the material of the plastic ampoule be selected from polyethylene (PE) plastics,
One kind of polyester (PET and PBT) plastics, polypropylene (PP) plastics or polyvinyl chloride (PVC) plastics.
The material of a kind of ganciclovir injection of the present invention, the plastic ampoule is selected from polypropylene plastics；It is described
PH adjusting agent is sodium hydroxide.
A kind of ganciclovir injection of the present invention, the ganciclovir injection specification are every 5ml, contain more former times
Lip river Wei 0.25g.
A kind of ganciclovir injection of the present invention, the ganciclovir injection further include that motherwort folds olefin(e) acid ester
A。
The preparation process of ganciclovir injection of the present invention, the preparation process specific steps are as follows: 1) injection
Water is added with stirring the sodium hydroxide of 1/10 Ganciclovir amount, is stirred to dissolve, and the Ganciclovir of recipe quantity is slowly poured into, is stirred
Mixing makes to be completely dissolved；PH value is adjusted to 11.2 with sodium hydroxide；2) active carbon that 0.3% (w/v) is added stirs 10 minutes, is not added
Water for injection filtration cycle 15 minutes, after sample detection content, pH value are qualified, is pacified to full dose with three-in-one device plastics PP
Small jar, filling, sealing；It sterilizes 30 minutes in 115 DEG C, packs, examine after lamp inspection is qualified.
It is in depth analyzed and researched, is had found easily by easily occurring the mechanism of turbidity and precipitation to ganciclovir injection
The essential reason that appearance visible foreign matters are unqualified, particulate matter increases.Ganciclovir injection occur visible foreign matters it is unqualified,
The essential reason that particulate matter increases are as follows: when containing ganciclovir injection with glass ampule, since Ganciclovir is injected
Liquid is alkaline solution, and under the conditions of high-temperature sterilization or in storage, medical fluid often attack glass causes glass flake special
It is not its alkaline thin slice dissolution, leads to that visible foreign matters are unqualified, particulate matter gradually increases.Then, from directly contact medical fluid
Inner packaging material start with and solve ganciclovir injection the technology that visible foreign matters are unqualified, particulate matter increases occur difficult
Topic.Compared with prior art, ganciclovir injection of the present invention in the preparation selects packaged with plastic container material,
Make medical fluid and packaging material that good compatibility be presented, so that visible foreign matters and particulate matter be made to be remarkably decreased.
Specific embodiment
Ganciclovir injection of the present invention and its preparation process are done furtherly below with reference to specific embodiment
It is bright, but the scope of protection of the present invention is not limited thereto.
Embodiment 1
Prescription:
Technical process:
Preparation method are as follows:
(1) water for injection is added with stirring the sodium hydroxide of 1/10 Ganciclovir amount, is stirred to dissolve, more by recipe quantity
VACV is slowly poured into, and stirring makes to be completely dissolved.PH value is adjusted to 11.2 with sodium hydroxide.
(2) active carbon that 0.3% (w/v) is added stirs 10 minutes, does not add to the full amount of water for injection, filtration cycle 15 is divided
Clock, after sample detection content, pH value are qualified, with three-in-one device plastics PP ampoule, filling, sealing.It sterilizes 30 points in 115 DEG C
Clock.It packs, examines after lamp inspection is qualified.
Embodiment 2
Prescription:
Preparation method are as follows:
(1) water for injection is added with stirring the sodium hydroxide of recipe quantity, is stirred to dissolve, and the Ganciclovir of recipe quantity is slow
Slowly it pours into, stirring makes to be completely dissolved.PH value is adjusted to 11.2 with sodium carbonate.
(2) active carbon that 0.3% (w/v) is added stirs 10 minutes, does not add to the full amount of water for injection, filtration cycle 15 is divided
Clock, after sample detection content, pH value are qualified, with three-in-one device plastics PP ampoule, filling, sealing.It sterilizes 30 points in 115 DEG C
Clock.It packs, examines after lamp inspection is qualified.
Embodiment 3
Prescription:
Preparation method are as follows:
(1) water for injection is added with stirring the sodium hydroxide of recipe quantity, is stirred to dissolve, by the Ganciclovir of recipe quantity and
Motherwort folds olefin(e) acid ester A and slowly pours into, and stirring makes to be completely dissolved.PH value is adjusted to 11.2 with sodium carbonate.
(2) active carbon that 0.3% (w/v) is added stirs 10 minutes, does not add to the full amount of water for injection, filtration cycle 15 is divided
Clock, after sample detection content, pH value are qualified, with three-in-one device plastics PP ampoule, filling, sealing.It sterilizes 30 points in 115 DEG C
Clock.It packs, examines after lamp inspection is qualified.
Comparative examples
Prescription:
(1) water for injection is added with stirring the sodium hydroxide of 1/10 Ganciclovir amount, is stirred to dissolve, more by recipe quantity
VACV is slowly poured into, and stirring makes to be completely dissolved.PH value is adjusted to 11.2 with sodium hydroxide.
(2) active carbon that 0.3% (w/v) is added stirs 10 minutes, does not add to the full amount of water for injection, filtration cycle 15 is divided
Clock, after sample detection content, pH value are qualified, encapsulating sterilizes 30 minutes in the glass ampule that common process is cleaned in 115 DEG C.
It packs, examines after lamp inspection is qualified.
Compliance test result
Select visible foreign matters and particulate matter that the present invention is explained in further detail for 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, the results are shown in Table 1.
The various sample properties of table 1, pH value, the measurement result of visible foreign matters and particulate matter
Claims (5)
1. a kind of ganciclovir injection, which is characterized in that the ganciclovir injection includes Ganciclovir and pH adjusting agent；
The ganciclovir injection is the inner packing for directly contacting ganciclovir injection with plastic ampoule using water for injection as solvent
Container；The ganciclovir injection further includes that motherwort folds olefin(e) acid ester A.
2. a kind of ganciclovir injection according to claim 1, which is characterized in that the pH adjusting agent is selected from hydroxide
One in sodium, sodium bicarbonate, sodium carbonate, sodium citrate, potassium citrate, sodium lactate, sodium phosphate, dibastic sodium phosphate or sodium dihydrogen phosphate
Kind is a variety of.
3. a kind of ganciclovir injection according to claim 1, which is characterized in that the material of the plastic ampoule is selected from
One kind of vinyon, polyester plastics, polypropylene plastics or igelite.
4. a kind of ganciclovir injection according to claim 1, which is characterized in that the material of the plastic ampoule is selected from
Polypropylene plastics；The pH adjusting agent is sodium hydroxide.
5. a kind of ganciclovir injection according to claim 1, which is characterized in that the ganciclovir injection specification
For every 5ml, 0.25g containing Ganciclovir.
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 CN106176595A (en) | 2016-12-07 |
| CN106176595B true CN106176595B (en) | 2019-10-22 |
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| Application Number | Title | Priority Date | Filing Date |
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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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Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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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 |
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 |
-
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 (1)
| Title |
|---|
| 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;郑开颜等;《中国现代应用药学杂志》;20070930;第24卷(第7期);第652-653页 * |
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| Publication number | Publication date |
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| CN106176595A (en) | 2016-12-07 |
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