CN108785247A - A kind of preparation method of hydrochloride for injection Ramosetron - Google Patents
A kind of preparation method of hydrochloride for injection Ramosetron Download PDFInfo
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- CN108785247A CN108785247A CN201810887552.7A CN201810887552A CN108785247A CN 108785247 A CN108785247 A CN 108785247A CN 201810887552 A CN201810887552 A CN 201810887552A CN 108785247 A CN108785247 A CN 108785247A
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- ramosetron
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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
- A61K31/4184—1,3-Diazoles condensed with carbocyclic rings, e.g. benzimidazoles
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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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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Abstract
The invention discloses a kind of preparation methods of hydrochloride for injection Ramosetron, include the following steps：Mannitol is dissolved by water for injection is added in dense preparing tank, heats and stirs to mannitol and dissolve；Activated carbon stirring and adsorbing is added in dense preparing tank, the solution in dense preparing tank is squeezed into dilute preparing tank；Water for injection cooling is added in dilute preparing tank, Ramosetron HCl is added, stirring is extremely dissolved；Water for injection is added in the solution to total volume total amount of making up a prescription, is uniformly mixed obtained Ramosetron HCl product；Ramosetron HCl product freeze-drying is carried out again to sterilize to obtain the final product.Hydrochloride for injection Ramosetron obtained by the present invention passes through 3 grades of aseptic filtrations, substantially ensures the aseptic of product.
Description
Technical field
The invention belongs to pharmaceutical production technical field, the preparation method of specifically a kind of hydrochloride for injection Ramosetron.
Background technology
Currently, various pharmaceutical dosage forms have been made for clinical treatment in Ramosetron HCl, wherein not with hydrochloride for injection thunder
It is the most commonly used to take charge of fine jade, the huge market demand.In pharmaceutical preparation production process, hydrochloride for injection Ramosetron is made into hydrochloric acid thunder
Mo Siqiong freeze drying powder injections.The preparation method of existing Ramosetron HCl freeze drying powder injection includes：Using Ramosetron HCl,
Auxiliary material and water for injection stirring and dissolving, it is freeze-dried that Ramosetron HCl freeze drying powder injection is made.But existing hydrochloride for injection
Ramosetron preparation method is difficult to ensure its bactericidal effect, it is difficult to which the aseptic for ensureing product leads to unstable product quality.
Invention content
To solve the above-mentioned problems in the prior art, the present invention provides a kind of systems of hydrochloride for injection Ramosetron
Preparation Method.Hydrochloride for injection Ramosetron obtained by the preparation method passes through 3 grades of aseptic filtrations, substantially ensures the sterile of product
Property.
The technical solution adopted by the present invention is：
A kind of preparation method of hydrochloride for injection Ramosetron, includes the following steps：
S1, appropriate water for injection dissolving mannitol is added in dense preparing tank, is heated to 60 DEG C or more, stirring is molten to mannitol
Solution；
S2, activated carbon stirring and adsorbing is added in dense preparing tank, the solution in dense preparing tank is squeezed into dilute preparing tank；
S3, water for injection is added in dilute preparing tank to the 90% of the total volume that makes up a prescription, is cooled to room temperature, ramosetron hydrochloride department is added
Fine jade, stirring control the pH value of liquid between 3.8-4.2 to dissolving；
S4, in step s3 gained solution in be added water for injection to total volume total amount of making up a prescription, be uniformly mixed, control
Ramosetron HCl product is made between 3.8-4.2 in the pH value of pharmacy liquid；
S5, by step S4 on the plate layer of the Ramosetron HCl product household freezer that is transferred to freeze dryer of gained, by salt
The temperature of sour Ramosetron product is down to -45 DEG C, keeps the temperature 1.5h-6h；
S6, Ramosetron HCl product obtained by step S5 is warming up to -20 DEG C, keeps the temperature 1h-4h；
S7, Ramosetron HCl product obtained by step S6 is warming up to -10 DEG C, keeps the temperature 4h-8h；
S8, Ramosetron HCl product obtained by step S7 is warming up to -5 DEG C, keeps the temperature 2h-5h；
S9, Ramosetron HCl product obtained by step S8 is warming up to 0 DEG C, keeps the temperature 0.5h-1.5h；
S10, Ramosetron HCl product obtained by step S9 is warming up to 15 DEG C, keeps the temperature 0.5h-1.5h；The step S6-
Vacuum degree≤25Pa of freeze dryer in S10；
S11, Ramosetron HCl product obtained by step S10 is warming up to 45 DEG C, 2h-6h is to get hydrochloride for injection for heat preservation
Ramosetron.
Preferably, the solution in the step S2 in dense preparing tank squeezes into dilute preparing tank, the stud by stud filter
The aperture of filter is 0.45um.
Preferably, further including step S12 after the step S11, hydrochloride for injection Ramosetron being used brown glass
Tubular injection bottle is packed.
Preferably, it is in liquid to control method of the pH value of liquid between 3.8-4.2 in the step S3, step S4
Interior addition is adjusted with phosphoric acid solution.
Beneficial effects of the present invention are as follows：
1, the hydrochloride for injection Ramosetron obtained by the present invention passes through 3 grades of aseptic filtrations, substantially ensures the sterile of product
Property, improve the stability of product in use；
2, dense preparing tank, the dilute preparing tank that the present invention uses are on-line weighing system, are ensured accurate with the weighing of pendular ring section, constant volume
Really；
3, the present invention is packed using brown glass tubular injection bottle, is prevented influence of the light to product, is further ensured that
Product quality.
Specific implementation mode
The embodiment of the present invention is described in detail below.
Embodiment 1：
A kind of preparation method of hydrochloride for injection Ramosetron, includes the following steps：
S1,800ml waters for injection and 50g mannitol are added in dense preparing tank, are heated to 60 DEG C or more, stirring to mannitol
Dissolving；
S2,0.1g activated carbon stirring and adsorbings are added in dense preparing tank, the solution in dense preparing tank is squeezed by stud filter
The aperture of dilute preparing tank, the stud filter is 0.45um；
S3,100m l waters for injection are added in dilute preparing tank, are cooled to room temperature, 0.3g Ramosetron HCls, stirring is added
To dissolving；Addition is adjusted with phosphoric acid solution, and the pH value for controlling liquid is 3.8；
S4, in step s3 gained solution in be added 100ml waters for injection, be uniformly mixed, addition phosphoric acid is molten
Liquid is adjusted, and the pH value for controlling liquid is 3.8, and Ramosetron HCl product is made；
S5, by step S4 on the plate layer of the Ramosetron HCl product household freezer that is transferred to freeze dryer of gained, by salt
The temperature of sour Ramosetron product is down to -45 DEG C, keeps the temperature 1.5h, and step S5 is first order degerming；
S6, Ramosetron HCl product obtained by step S5 is warming up to -20 DEG C, keeps the temperature 1h；
S7, Ramosetron HCl product obtained by step S6 is warming up to -10 DEG C, keeps the temperature 4h；
S8, Ramosetron HCl product obtained by step S7 is warming up to -5 DEG C, keeps the temperature 2h；
S9, Ramosetron HCl product obtained by step S8 is warming up to 0 DEG C, keeps the temperature 0.5h；
S10, Ramosetron HCl product obtained by step S9 is warming up to 15 DEG C, keeps the temperature 0.5h；In the step S6-S10
Vacuum degree≤25Pa of freeze dryer, step S6-S10 are second level degerming；
S11, Ramosetron HCl product obtained by step S10 is warming up to 45 DEG C, heat preservation 2h to get hydrochloride for injection thunder not
Fine jade is taken charge of, step S11 is third level degerming.
S12, hydrochloride for injection Ramosetron is packed using brown glass tubular injection bottle.
Embodiment 2：
A kind of preparation method of hydrochloride for injection Ramosetron, includes the following steps：
S1,800ml waters for injection and 50g mannitol are added in dense preparing tank, are heated to 60 DEG C or more, stirring to mannitol
Dissolving；
S2,0.1g activated carbon stirring and adsorbings are added in dense preparing tank, the solution in dense preparing tank is squeezed by stud filter
The aperture of dilute preparing tank, the stud filter is 0.45um；
S3,100m l waters for injection are added in dilute preparing tank, are cooled to room temperature, 0.3g Ramosetron HCls, stirring is added
To dissolving；Addition is adjusted with phosphoric acid solution, and the pH value for controlling liquid is 4.2；
S4, in step s3 gained solution in be added 100ml waters for injection, be uniformly mixed, addition phosphoric acid is molten
Liquid is adjusted, and the pH value for controlling liquid is 4.2, and Ramosetron HCl product is made；
S5, by step S4 on the plate layer of the Ramosetron HCl product household freezer that is transferred to freeze dryer of gained, by salt
The temperature of sour Ramosetron product is down to -45 DEG C, keeps the temperature 6h, and step S5 is first order degerming；
S6, Ramosetron HCl product obtained by step S5 is warming up to -20 DEG C, keeps the temperature 4h；
S7, Ramosetron HCl product obtained by step S6 is warming up to -10 DEG C, keeps the temperature 8h；
S8, Ramosetron HCl product obtained by step S7 is warming up to -5 DEG C, keeps the temperature 5h；
S9, Ramosetron HCl product obtained by step S8 is warming up to 0 DEG C, keeps the temperature 1.5h；
S10, Ramosetron HCl product obtained by step S9 is warming up to 15 DEG C, keeps the temperature 1.5h；In the step S6-S10
Vacuum degree≤25Pa of freeze dryer, step S6-S10 are second level degerming；
S11, Ramosetron HCl product obtained by step S10 is warming up to 45 DEG C, heat preservation 6h to get hydrochloride for injection thunder not
Fine jade is taken charge of, step S11 is third level degerming.
S12, hydrochloride for injection Ramosetron is packed using brown glass tubular injection bottle.
Embodiment 3：
A kind of preparation method of hydrochloride for injection Ramosetron, includes the following steps：
S1,800ml waters for injection and 50g mannitol are added in dense preparing tank, are heated to 60 DEG C or more, stirring to mannitol
Dissolving；
S2,0.1g activated carbon stirring and adsorbings are added in dense preparing tank, the solution in dense preparing tank is squeezed by stud filter
The aperture of dilute preparing tank, the stud filter is 0.45um；
S3,100m l waters for injection are added in dilute preparing tank, are cooled to room temperature, 0.3g Ramosetron HCls, stirring is added
To dissolving；Addition is adjusted with phosphoric acid solution, and the pH value for controlling liquid is 4；
S4, in step s3 gained solution in be added 100ml waters for injection, be uniformly mixed, addition phosphoric acid is molten
Liquid is adjusted, and the pH value for controlling liquid is 4, and Ramosetron HCl product is made；
S5, by step S4 on the plate layer of the Ramosetron HCl product household freezer that is transferred to freeze dryer of gained, by salt
The temperature of sour Ramosetron product is down to -45 DEG C, keeps the temperature 3h, and step S5 is first order degerming；
S6, Ramosetron HCl product obtained by step S5 is warming up to -20 DEG C, keeps the temperature 3h；
S7, Ramosetron HCl product obtained by step S6 is warming up to -10 DEG C, keeps the temperature 6h；
S8, Ramosetron HCl product obtained by step S7 is warming up to -5 DEG C, keeps the temperature 3h；
S9, Ramosetron HCl product obtained by step S8 is warming up to 0 DEG C, keeps the temperature 1h；
S10, Ramosetron HCl product obtained by step S9 is warming up to 15 DEG C, keeps the temperature 1h；Freeze in the step S6-S10
Vacuum degree≤25Pa of dry machine, step S6-S10 are second level degerming；
S11, Ramosetron HCl product obtained by step S10 is warming up to 45 DEG C, heat preservation 4h to get hydrochloride for injection thunder not
Fine jade is taken charge of, step S11 is third level degerming.
S12, hydrochloride for injection Ramosetron is packed using brown glass tubular injection bottle.
Specific implementation mode of the invention above described embodiment only expresses, the description thereof is more specific and detailed, but simultaneously
Cannot the limitation to the scope of the claims of the present invention therefore be interpreted as.It should be pointed out that for those of ordinary skill in the art
For, without departing from the inventive concept of the premise, various modifications and improvements can be made, these belong to the guarantor of the present invention
Protect range.
Claims (4)
1. a kind of preparation method of hydrochloride for injection Ramosetron, which is characterized in that include the following steps：
S1, appropriate water for injection dissolving mannitol is added in dense preparing tank, is heated to 60 DEG C or more, stirring to mannitol is dissolved；
S2, activated carbon stirring and adsorbing is added in dense preparing tank, the solution in dense preparing tank is squeezed into dilute preparing tank；
S3, water for injection is added in dilute preparing tank to the 90% of the total volume that makes up a prescription, is cooled to room temperature, Ramosetron HCl is added,
Stirring controls the pH value of liquid between 3.8-4.2 to dissolving；
S4, in step s3 gained solution in be added water for injection to total volume total amount of making up a prescription, be uniformly mixed, control medicine
Ramosetron HCl product is made between 3.8-4.2 in the pH value of liquid；
S5, by step S4 on the plate layer of the Ramosetron HCl product household freezer that is transferred to freeze dryer of gained, by hydrochloric acid thunder
The temperature of Mo Siqiong products is down to -45 DEG C, keeps the temperature 1.5h-6h；
S6, Ramosetron HCl product obtained by step S5 is warming up to -20 DEG C, keeps the temperature 1h-4h；
S7, Ramosetron HCl product obtained by step S6 is warming up to -10 DEG C, keeps the temperature 4h-8h；
S8, Ramosetron HCl product obtained by step S7 is warming up to -5 DEG C, keeps the temperature 2h-5h；
S9, Ramosetron HCl product obtained by step S8 is warming up to 0 DEG C, keeps the temperature 0.5h-1.5h；
S10, Ramosetron HCl product obtained by step S9 is warming up to 15 DEG C, keeps the temperature 0.5h-1.5h；In the step S6-S10
Vacuum degree≤25Pa of freeze dryer；
S11, Ramosetron HCl product obtained by step S10 is warming up to 45 DEG C, heat preservation 2h-6h to get hydrochloride for injection thunder not
Take charge of fine jade.
2. a kind of preparation method of hydrochloride for injection Ramosetron according to claim 1, which is characterized in that the step
Solution in S2 in dense preparing tank squeezes into dilute preparing tank by stud filter, and the aperture of the stud filter is 0.45um.
3. a kind of preparation method of hydrochloride for injection Ramosetron according to claim 1, which is characterized in that the step
Further include step S12 after S11, pack hydrochloride for injection Ramosetron using brown glass tubular injection bottle.
4. a kind of preparation method of hydrochloride for injection Ramosetron according to claim 1, which is characterized in that the step
It is that addition is adjusted with phosphoric acid solution in liquid that method of the pH value of liquid between 3.8-4.2 is controlled in S3, step S4.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810887552.7A CN108785247A (en) | 2018-08-06 | 2018-08-06 | A kind of preparation method of hydrochloride for injection Ramosetron |
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| CN201810887552.7A CN108785247A (en) | 2018-08-06 | 2018-08-06 | A kind of preparation method of hydrochloride for injection Ramosetron |
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Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102101858A (en) * | 2009-12-21 | 2011-06-22 | 天津康鸿医药科技发展有限公司 | Preparation method of ramosetron derivatives and applications thereof |
| WO2012091357A2 (en) * | 2010-12-27 | 2012-07-05 | Samyang Biopharmaceuticals Corporation | Composition for prevention of nausea or vomiting |
| CN103211771A (en) * | 2012-01-18 | 2013-07-24 | 浙江亚太药业股份有限公司 | Ramosetron hydrochloride freeze-dried powder injection and preparation method thereof |
| CN103330710A (en) * | 2013-06-27 | 2013-10-02 | 海南卫康制药(潜山)有限公司 | Ramosetron composition for injection |
| CN103536566A (en) * | 2013-10-28 | 2014-01-29 | 江苏红豆杉药业有限公司 | Ramosetron hydrochloride injection and preparation method thereof |
| WO2014163215A1 (en) * | 2013-04-02 | 2014-10-09 | 제일약품주식회사 | Pharmaceutical composition having masked bitter taste |
| CN106265538A (en) * | 2016-08-31 | 2017-01-04 | 湖南科伦制药有限公司 | A kind of preparation method of Ramosetron HCl lyophilized injectable powder |
-
2018
- 2018-08-06 CN CN201810887552.7A patent/CN108785247A/en active Pending
Patent Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102101858A (en) * | 2009-12-21 | 2011-06-22 | 天津康鸿医药科技发展有限公司 | Preparation method of ramosetron derivatives and applications thereof |
| WO2012091357A2 (en) * | 2010-12-27 | 2012-07-05 | Samyang Biopharmaceuticals Corporation | Composition for prevention of nausea or vomiting |
| CN103211771A (en) * | 2012-01-18 | 2013-07-24 | 浙江亚太药业股份有限公司 | Ramosetron hydrochloride freeze-dried powder injection and preparation method thereof |
| WO2014163215A1 (en) * | 2013-04-02 | 2014-10-09 | 제일약품주식회사 | Pharmaceutical composition having masked bitter taste |
| CN103330710A (en) * | 2013-06-27 | 2013-10-02 | 海南卫康制药(潜山)有限公司 | Ramosetron composition for injection |
| CN103536566A (en) * | 2013-10-28 | 2014-01-29 | 江苏红豆杉药业有限公司 | Ramosetron hydrochloride injection and preparation method thereof |
| CN106265538A (en) * | 2016-08-31 | 2017-01-04 | 湖南科伦制药有限公司 | A kind of preparation method of Ramosetron HCl lyophilized injectable powder |
Non-Patent Citations (1)
| Title |
|---|
| 孟胜男等主编: "《药剂学》", 31 January 2016, 中国医药科技出版社 * |
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Application publication date: 20181113 |