CN109464386A - Ondansetron hydrochloride injection and preparation method thereof - Google Patents
Ondansetron hydrochloride injection and preparation method thereof Download PDFInfo
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- CN109464386A CN109464386A CN201811567492.7A CN201811567492A CN109464386A CN 109464386 A CN109464386 A CN 109464386A CN 201811567492 A CN201811567492 A CN 201811567492A CN 109464386 A CN109464386 A CN 109464386A
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- injection
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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
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- 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
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4164—1,3-Diazoles
- A61K31/4178—1,3-Diazoles not condensed 1,3-diazoles and containing further heterocyclic rings, e.g. pilocarpine, nitrofurantoin
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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
- A61K9/0012—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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/08—Drugs for disorders of the alimentary tract or the digestive system for nausea, cinetosis or vertigo; Antiemetics
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- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
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- General Health & Medical Sciences (AREA)
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- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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- Dermatology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention discloses a kind of ondansetron hydrochloride injection and preparation method thereof, the preparation method includes: that water for injection is added in material-compound tank, and ondansetron hydrochloride is added after heating, and stirring is so that it is dissolved；Hydrochloric acid solution or sodium hydroxide solution is added in material-compound tank to adjust within the scope of pH to 6.5-7.5；Injection active carbon is added in material-compound tank, stirring is returned after filter with pump through stud filter, and injection is obtained；It is filled into injection aseptic filtration in vial, seals, carries out pressure sterilizing, obtain ondansetron hydrochloride injection.The preparation method of the ondansetron hydrochloride injection is simple, and has excellent pharmaceutical properties.
Description
Technical field
The present invention relates to injections, and in particular, to a kind of ondansetron hydrochloride injection and preparation method thereof.
Background technique
Ondansetron hydrochloride injection, indication be this product be used for control cancer chemotherapy and radiotherapy together nausea and
Vomiting；Also it is suitable for prevention and postoperative nauseaand vomiting；Children: 4 years old or more children: the evil of control cancer chemotherapy and radiotherapy together
The heart and vomiting；4 years old or less children: nausea and vomiting caused by control cancer chemotherapy；2 years old or more children: after preventing and treating operation
Nausea and vomiting.
There is provided a kind of ondansetron hydrochloride injection and preparation method thereof with excellent pharmaceutical properties is that the present invention needs
It solves the problems, such as.
Summary of the invention
The object of the present invention is to provide a kind of ondansetron hydrochloride injection and preparation method thereof, ondansetron hydrochloride notes
The preparation method for penetrating liquid is simple, and has excellent pharmaceutical properties.
To achieve the goals above, the present invention provides a kind of preparation method of ondansetron hydrochloride injection, the systems
Preparation Method includes:
(1) water for injection is added in material-compound tank, ondansetron hydrochloride is added after heating, stirring is so that it is dissolved；
(2) hydrochloric acid solution or sodium hydroxide solution is added in material-compound tank to adjust within the scope of pH to 6.5-7.5；
(3) injection active carbon is added in material-compound tank, stirring is returned after filter with pump through stud filter, and injection is obtained；
(4) it by injection aseptic filtration, is filled into vial, seals, carry out pressure sterilizing, obtain ondansetron hydrochloride
Injection.
The present invention also provides a kind of preparation method of ondansetron hydrochloride injection, the ondansetron hydrochloride injection
It is made by above-mentioned preparation method.
According to the above technical scheme, described the present invention provides a kind of ondansetron hydrochloride injection and preparation method thereof
Preparation method includes: that water for injection is added in material-compound tank, and ondansetron hydrochloride is added after heating, and stirring is so that it is dissolved；?
Hydrochloric acid solution or sodium hydroxide solution are added in material-compound tank to adjust within the scope of pH to 6.5-7.5；Injection is added in material-compound tank
With active carbon, stirring is returned after filter with pump through stud filter, obtains injection；By injection aseptic filtration, it is filled into vial
In, sealing carries out pressure sterilizing, obtains ondansetron hydrochloride injection.Preparation method provided by the invention, method is simple, obtains
To ondansetron hydrochloride injection have excellent pharmaceutical properties.
Other features and advantages of the present invention will the following detailed description will be given in the detailed implementation section.
Specific embodiment
Detailed description of the preferred embodiments below.It should be understood that described herein specific
Embodiment is merely to illustrate and explain the present invention, and is not intended to restrict the invention.
The present invention provides a kind of preparation method of ondansetron hydrochloride injection, the preparation method includes:
(1) water for injection is added in material-compound tank, ondansetron hydrochloride is added after heating, stirring is so that it is dissolved；
(2) hydrochloric acid solution or sodium hydroxide solution is added in material-compound tank to adjust within the scope of pH to 6.5-7.5；
(3) injection active carbon is added in material-compound tank, stirring is returned after filter with pump through stud filter, and injection is obtained；
(4) it by injection aseptic filtration, is filled into vial, seals, carry out pressure sterilizing, obtain ondansetron hydrochloride
Injection.
In a preferred embodiment of the invention, in order to further increase the pharmacy of ondansetron hydrochloride injection
Property, relative to the water for injection of 100mL, the dosage of ondansetron hydrochloride is 1.5-1.65mg.
In a preferred embodiment of the invention, in order to further increase the pharmacy of ondansetron hydrochloride injection
Property, in step (1), the condition of stirring includes: that the temperature of stirring is 45-55 DEG C, and the time of stirring is 10-15min.
In a preferred embodiment of the invention, in order to further increase the pharmacy of ondansetron hydrochloride injection
Property, the volumetric concentration of hydrochloric acid solution are 24-32%；And/or
The volumetric concentration of sodium hydroxide solution is 20-30%.
In a preferred embodiment of the invention, in order to further increase the pharmacy of ondansetron hydrochloride injection
Property, relative to the water for injection of 100mL, the dosage of injection active carbon is 0.2-0.5mg.
In a preferred embodiment of the invention, in order to further increase the pharmacy of ondansetron hydrochloride injection
Property, in step (3), the condition of stirring includes: that the temperature of stirring is 55-65 DEG C, and the time of stirring is 12-15min.
In a preferred embodiment of the invention, in order to further increase the pharmacy of ondansetron hydrochloride injection
Property, the aperture of stud are 1-3 μm.
In a preferred embodiment of the invention, in order to further increase the pharmacy of ondansetron hydrochloride injection
Property, the condition of pressure sterilizing include: that temperature is 200-250 DEG C, time 20-30min.
The present invention also provides a kind of preparation method of ondansetron hydrochloride injection, the ondansetron hydrochloride injection
It is made by above-mentioned preparation method.
It is illustrated below by way of specific embodiment.
Embodiment 1
100mL water for injection is added in material-compound tank, ondansetron hydrochloride 1.5mg is added after heating, stirs (the temperature of stirring
Degree is 45 DEG C, and the time of stirring is 10min) make its dissolution；The hydrochloric acid solution that volumetric concentration is 24% is added in material-compound tank
Or the sodium hydroxide solution that volumetric concentration is 20% is to adjust in pH to 6.5 ranges；Injection active carbon is added in material-compound tank
0.2mg, with pump, through stud, (aperture of stud is 1 after stirring (temperature of stirring is 55 DEG C, and the time of stirring is 12min), time filter
μm) filter, obtain injection；It is filled into injection aseptic filtration in vial, seals, carrying out pressure sterilizing, (temperature is
200 DEG C, time 20min), obtain ondansetron hydrochloride injection.
Embodiment 2
100mL water for injection is added in material-compound tank, ondansetron hydrochloride 1.65mg is added after heating, stirring be (stirring
Temperature is 55 DEG C, and the time of stirring is 15min) make its dissolution；It is molten that the hydrochloric acid that volumetric concentration is 32% is added in material-compound tank
The sodium hydroxide solution that liquid or volumetric concentration are 30% is to adjust in pH to 7.5 ranges；Injection activity is added in material-compound tank
Charcoal 0.5mg, stirring (temperature of stirring is 65 DEG C, and the time of stirring is 15min) are returned after filter with pump through the stud (aperture of stud
It is 3 μm) filter, obtain injection；It is filled into injection aseptic filtration in vial, seals, carries out pressure sterilizing (temperature
Degree is 250 DEG C, time 30min), obtain ondansetron hydrochloride injection.
Embodiment 3
100mL water for injection is added in material-compound tank, ondansetron hydrochloride 1.6mg is added after heating, stirs (the temperature of stirring
Degree is 50 DEG C, and the time of stirring is 12min) make its dissolution；The hydrochloric acid solution that volumetric concentration is 28% is added in material-compound tank
Or the sodium hydroxide solution that volumetric concentration is 25% is to adjust in pH to 7 ranges；Injection active carbon is added in material-compound tank
0.35mg, with pump, through stud, (aperture of stud is after stirring (temperature of stirring is 60 DEG C, and the time of stirring is 13min), time filter
2 μm) filter, obtain injection；It is filled into injection aseptic filtration in vial, seals, carries out pressure sterilizing (temperature
It is 220 DEG C, time 25min), obtain ondansetron hydrochloride injection.
Test case
Take injection, set 40 DEG C of dark places and place 6 months, measure active component content of the injection at 0 month and June,
Related substance, pH value.For active component content change, each injection calculate its at June content relative to its 0 month when contain
The percentage of amount, as remaining percentage composition, typically the remaining percentage composition of drug should be greater than 90% and be only to think qualified
's.Injection in example 1 above -3, after measured, their related substances and pH value at June are in the model of States Pharmacopoeia specifications
In enclosing；Such as under 216nm wavelength, the single impurity of ondansetron hydrochloride injection is respectively less than 0.15%, the sum of each impurity peak area
Respectively less than 0.46%；Under 328nm wavelength, ondansetron hydrochloride impurity is respectively less than 0.62%；Their pH value at June exist
Within the scope of 3.0-4.0.Injection in example 1 above -3, after measured, their active constituent remnants percentages at June contain
Amount shows that whole injections all have excellent stability in 95~99% ranges.
The preferred embodiment of the present invention has been described above in detail, still, during present invention is not limited to the embodiments described above
Detail within the scope of the technical concept of the present invention can be with various simple variants of the technical solution of the present invention are made, this
A little simple variants all belong to the scope of protection of the present invention.
It is further to note that specific technical features described in the above specific embodiments, in not lance
In the case where shield, can be combined in any appropriate way, in order to avoid unnecessary repetition, the present invention to it is various can
No further explanation will be given for the combination of energy.
In addition, various embodiments of the present invention can be combined randomly, as long as it is without prejudice to originally
The thought of invention, it should also be regarded as the disclosure of the present invention.
Claims (9)
1. a kind of preparation method of ondansetron hydrochloride injection, which is characterized in that the preparation method includes:
(1) water for injection is added in material-compound tank, ondansetron hydrochloride is added after heating, stirring is so that it is dissolved；
(2) hydrochloric acid solution or sodium hydroxide solution is added in material-compound tank to adjust within the scope of pH to 6.5-7.5；
(3) injection active carbon is added in material-compound tank, stirring is returned after filter with pump through stud filter, and injection is obtained；
(4) it by injection aseptic filtration, is filled into vial, seals, carry out pressure sterilizing, obtain ondansetron hydrochloride injection
Liquid.
2. preparation method according to claim 1, wherein relative to the water for injection of 100mL, the use of ondansetron hydrochloride
Amount is 1.5-1.65mg.
3. preparation method according to claim 1, wherein in step (1), the condition of stirring includes: the temperature of stirring
It is 45-55 DEG C, the time of stirring is 10-15min.
4. preparation method according to claim 1, wherein the volumetric concentration of hydrochloric acid solution is 24-32%；And/or
The volumetric concentration of sodium hydroxide solution is 20-30%.
5. preparation method according to claim 1, wherein relative to the water for injection of 100mL, the use of injection active carbon
Amount is 0.2-0.5mg.
6. preparation method according to claim 1, wherein in step (3), the condition of stirring includes: the temperature of stirring
It is 55-65 DEG C, the time of stirring is 12-15min.
7. preparation method according to claim 1, wherein the aperture of stud is 1-3 μm.
8. preparation method according to claim 1, wherein the condition of pressure sterilizing includes: that temperature is 200-250 DEG C, when
Between be 20-30min.
9. a kind of preparation method of ondansetron hydrochloride injection, which is characterized in that the ondansetron hydrochloride injection is by weighing
Benefit requires preparation method described in any one of 1-8 to be made.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811567492.7A CN109464386A (en) | 2018-12-20 | 2018-12-20 | Ondansetron hydrochloride injection and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811567492.7A CN109464386A (en) | 2018-12-20 | 2018-12-20 | Ondansetron hydrochloride injection and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN109464386A true CN109464386A (en) | 2019-03-15 |
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ID=65676351
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201811567492.7A Pending CN109464386A (en) | 2018-12-20 | 2018-12-20 | Ondansetron hydrochloride injection and preparation method thereof |
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| Country | Link |
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| CN (1) | CN109464386A (en) |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1555795A (en) * | 2004-01-08 | 2004-12-22 | 陈庆财 | Ondansijiong hydrochleride freeze dried powder ampoule for injection and its preparation method |
| CN103393693A (en) * | 2013-08-02 | 2013-11-20 | 海南灵康制药有限公司 | Pharmaceutical composition of ondansetron hydrochloride and dexamethasone |
| CN104274395A (en) * | 2014-09-19 | 2015-01-14 | 威海爱威制药有限公司 | Ondansetron hydrochloride sodium chloride injection and preparation method thereof |
| CN105769759A (en) * | 2016-04-13 | 2016-07-20 | 山东北大高科华泰制药有限公司 | Ondansetron hydrochloride injection composition and preparing method |
-
2018
- 2018-12-20 CN CN201811567492.7A patent/CN109464386A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1555795A (en) * | 2004-01-08 | 2004-12-22 | 陈庆财 | Ondansijiong hydrochleride freeze dried powder ampoule for injection and its preparation method |
| CN103393693A (en) * | 2013-08-02 | 2013-11-20 | 海南灵康制药有限公司 | Pharmaceutical composition of ondansetron hydrochloride and dexamethasone |
| CN104274395A (en) * | 2014-09-19 | 2015-01-14 | 威海爱威制药有限公司 | Ondansetron hydrochloride sodium chloride injection and preparation method thereof |
| CN105769759A (en) * | 2016-04-13 | 2016-07-20 | 山东北大高科华泰制药有限公司 | Ondansetron hydrochloride injection composition and preparing method |
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Application publication date: 20190315 |