CN107375201B - Flunixin meglumine injection and production method thereof - Google Patents
Flunixin meglumine injection and production method thereof Download PDFInfo
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- CN107375201B CN107375201B CN201710498945.4A CN201710498945A CN107375201B CN 107375201 B CN107375201 B CN 107375201B CN 201710498945 A CN201710498945 A CN 201710498945A CN 107375201 B CN107375201 B CN 107375201B
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- injection
- flunixin meglumine
- anhydrous sodium
- sodium sulfite
- flunixin
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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
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
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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
- A61K47/02—Inorganic compounds
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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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
Abstract
The invention relates to a flunixin meglumine injection and a production method thereof, wherein the method comprises the following steps: s1: adding 10-40% of water for injection and 10-30% of ethanol into the mixture in a preset preparation volume; s2: dissolving anhydrous sodium sulfite; s3: adding flunixin meglumine into a preparation container, and then adding an anhydrous sodium sulfite solution; s4: adding water for injection to a preset preparation volume, and adjusting the pH value; s5: adding water for injection to full volume, and stirring; s6: filtering and encapsulating; s7: sterilizing and inspecting by lamp; wherein the volume ratio of the added anhydrous sodium sulfite to the flunixin meglumine injection is between 1 and 3g/L, and the volume ratio of the added flunixin meglumine to the flunixin meglumine injection is between 80 and 90 g/L. The flunixin meglumine injection produced by the production method of the flunixin meglumine injection prolongs the quality guarantee period and ensures the product quality.
Description
Technical Field
The invention relates to the field of animal husbandry pharmacy, and in particular relates to a flunixin meglumine injection and a production method thereof.
Background
Flunixin meglumine injection is a product in the pharmacopoeia of the people's republic of China, and has been produced for many years. However, after the product produced by the existing production process is stored for several months, floccules appear and visible foreign matters are unqualified, so that a user returns the product for many times, great resource waste is caused to a manufacturer, adverse effects are caused to customers, and the reputation of a company is influenced.
Therefore, there is a need for improvement in the existing methods for producing flunixin meglumine injection.
Disclosure of Invention
In order to solve the defects of the prior art, the invention provides a production method of flunixin meglumine injection, which comprises the following steps:
s1: adding 10-40% of water for injection and 10-30% of ethanol into a preparation container, and stirring;
s2: taking a proper amount of water for injection, and dissolving a predetermined amount of anhydrous sodium sulfite;
s3: adding a predetermined amount of flunixin meglumine to the preparation container to be completely dissolved, and then adding a predetermined amount of anhydrous sodium sulfite solution dissolved in the step S2;
s4: adding water for injection to a predetermined preparation volume, and adjusting the pH value to be 8.2-8.8;
s5: adding water for injection to full volume, and stirring for a certain time;
s6: filtering and encapsulating;
s7: sterilizing and performing light inspection to obtain the flunixin meglumine injection;
in the step S2, the volume ratio of the added anhydrous sodium sulfite to the flunixin meglumine injection is between 1 and 3 g/L;
in the step S3, the volume ratio of the added flunixin meglumine to the flunixin meglumine injection is between 80 and 90 g/L;
in step S4, the pH is adjusted using ethanolamine.
Wherein, in the step S1, the volume ratio of the added ethanol to the flunixin meglumine injection is between 180 and 220 ml/L.
Wherein, in the step S1, the volume ratio of the added ethanol to the flunixin meglumine injection is 190-210 ml/L.
Wherein, in the step S2, the volume ratio of the added anhydrous sodium sulfite to the flunixin meglumine injection is 2-3 g/L.
Wherein, the step S6 specifically includes the following steps:
s61: filtering with 0.45um organic filter element;
s62: filtering with 0.22um organic filter element;
s63: and (5) encapsulating after the detection is qualified.
The invention also provides a flunixin meglumine injection which comprises the following components in parts by weight: ethanol, 180 and 220 ml/L; 80-90g/L of flunixin meglumine; 1-3g/L of anhydrous sodium sulfite, wherein the solvent of the flunixin meglumine injection is water for injection.
Wherein, the content of the ethanol in the flunixin meglumine injection is 190-210 ml/L.
Wherein, the content of ethanol in the flunixin meglumine injection is 200 ml/L.
Wherein, the content of anhydrous sodium sulfite in the flunixin meglumine injection is 2 g/L.
The invention has the beneficial effects that:
the flunixin meglumine injection produced by the production method of the flunixin meglumine injection provided by the invention has stable product quality after ethanol is added, the difficult problem of precipitation is solved, the produced flunixin meglumine injection is stored for more than two years, and all indexes are qualified.
Detailed Description
In order to further understand the technical solution and the advantages of the present invention, the following detailed description will be provided for the technical solution and the advantages thereof.
The invention provides a production method of flunixin meglumine injection, which comprises the following steps:
s1: adding 10-40% of water for injection and 10-30% of ethanol into a preparation container, and stirring;
s2: taking a proper amount of water for injection, and dissolving a predetermined amount of anhydrous sodium sulfite;
s3: adding a predetermined amount of flunixin meglumine to the preparation container to be completely dissolved, and then adding a predetermined amount of anhydrous sodium sulfite solution dissolved in the step S2;
s4: adding water for injection to a predetermined preparation volume, and adjusting the pH value to 8.2-8.8 to obtain a semi-finished product;
s5: adding water for injection into the semi-finished product to obtain a liquid medicine, and stirring for a certain time;
s6: filtering with 0.45um and 0.22um organic filter element, and bottling;
s7: sterilizing and inspecting by lamp to obtain the flunixin meglumine injection.
In the present invention, in step S7, the lamp may be detected to be a colorless or pale yellow clear liquid by sterilizing with flowing steam at 110 degrees celsius once every half hour.
In the invention, in the step S2, the volume ratio of the added anhydrous sodium sulfate to the flunixin meglumine injection is between 1 and 3 g/L; preferably, between 2 and 3 g/L; more preferably, it is 2; in step S1, the volume ratio of the added ethanol to the flunixin meglumine injection is between 180 and 220ml/L, preferably between 190 and 210 ml/L; more preferably, it is 200 ml/L. That is, the invention can achieve the purposes of reducing flocculent precipitate and stabilizing the finished product by removing the content of thiourea in the formula.
In the present invention, in the step S3, the volume ratio of the added flunixin meglumine to the flunixin meglumine injection is between 80 and 90g/L, preferably 83 g/L.
In the present invention, in step S4, the pH is adjusted using ethanolamine. In the preparation process of the steps S1 to S4, the temperature is controlled between 40 ℃ and 50 ℃ under normal pressure, and the temperature is reduced to the room temperature before the injection water is added to the full amount in the step S5.
The invention also provides a flunixin meglumine injection prepared by the production method.
The invention provides a production method of flunixin meglumine injection, and in specific implementation, the invention provides the following specific processing methods.
Example 1:
s1: adding 20% of water for injection and 20% of ethanol into a preparation container, stirring, and heating to 40-50 deg.C;
s2: taking a proper amount of water for injection, and dissolving a predetermined amount of anhydrous sodium sulfite, wherein the volume ratio of the anhydrous sodium sulfite to the flunixin meglumine injection is 2 g/L;
s3: adding a predetermined amount of flunixin meglumine into the preparation container, completely dissolving the flunixin meglumine, and then adding a predetermined amount of flunixin meglumine dissolved in the step S2; wherein the volume ratio of the added flunixin meglumine to the flunixin meglumine injection is 83 g/L;
s4: adding water for injection to a predetermined preparation volume, and adjusting pH value to 8.2-8.2 by ethanolamine;
s5: adding the injection water into the solution obtained in the step S4 to obtain a liquid medicine, and stirring for 10 minutes;
in the process of preparing the solution from S1 to S4, the temperature is controlled between 40 ℃ and 50 ℃ under normal pressure, and the solution is cooled to room temperature before the injection water is added to the full amount in the step S5.
S6: respectively filtering by using 0.45um organic filter element and 0.22um organic filter element; after the visible foreign matters in the liquid medicine are inspected to be qualified, the liquid medicine is conveyed to a filling and sealing station for filling and sealing;
s7: sterilizing and inspecting by lamp to obtain the flunixin meglumine injection.
Table 1 shows the results of the damage experiment of the flunixin meglumine injection prepared in example 1 of the present invention, and as shown in table 1, the flunixin meglumine injection prepared in example 1 of the present invention has good product stability, and can maintain stability for at least eighteen months under high temperature, illumination or freezing conditions.
Table 1: results of the Damage test of the Flunixin meglumine injection prepared in example 1
Example 2:
s1: adding 20% of water for injection and 30% of ethanol into a preparation container, stirring, and heating to 40-50 deg.C;
s2: taking a proper amount of water for injection, and dissolving a predetermined amount of anhydrous sodium sulfite, wherein the volume ratio of the anhydrous sodium sulfite to the flunixin meglumine injection is 2 g/L;
s3: adding a predetermined amount of flunixin meglumine into the preparation container, completely dissolving the flunixin meglumine, and then adding a predetermined amount of flunixin meglumine dissolved in the step S2; wherein the volume ratio of the added flunixin meglumine to the flunixin meglumine injection is 83 g/L;
s4: adding water for injection to a predetermined preparation volume, and adjusting pH value to 8.2-8.2 by ethanolamine;
s5: adding the injection water into the solution obtained in the step S4 to obtain a liquid medicine, and stirring for 10 minutes;
in the process of preparing the solution from S1 to S4, the temperature is controlled between 40 ℃ and 50 ℃ under normal pressure, and the solution is cooled to room temperature before the injection water is added to the full amount in the step S5.
S6: respectively filtering by using 0.45um organic filter element and 0.22um organic filter element; after the visible foreign matters in the liquid medicine are inspected to be qualified, the liquid medicine is conveyed to a filling and sealing station for filling and sealing;
s7: sterilizing and inspecting by lamp to obtain the flunixin meglumine injection.
Table 2 shows the results of the damage experiment of the flunixin meglumine injection prepared in example 2 of the present invention, and as shown in table 1, the flunixin meglumine injection prepared in example 2 of the present invention has good product stability, and can maintain stability for at least eighteen months under high temperature, illumination or freezing conditions.
Table 2: example 2 results of the Damage test of Flunixin meglumine injection prepared
Example 3
S1: adding 20% of injection water and 10% of ethanol into a preparation container, stirring, and heating to 40-50 deg.C;
s2: taking a proper amount of water for injection, and dissolving a predetermined amount of anhydrous sodium sulfite, wherein the volume ratio of the anhydrous sodium sulfite to the flunixin meglumine injection is 2 g/L;
s3: adding a predetermined amount of flunixin meglumine into the preparation container, completely dissolving the flunixin meglumine, and then adding a predetermined amount of flunixin meglumine dissolved in the step S2; wherein the volume ratio of the added flunixin meglumine to the flunixin meglumine injection is 83 g/L;
s4: adding water for injection to a predetermined preparation volume, and adjusting pH value to 8.2-8.2 by ethanolamine;
s5: adding the injection water into the solution obtained in the step S4 to obtain a liquid medicine, and stirring for 10 minutes;
in the process of preparing the solution from S1 to S4, the temperature is controlled between 40 ℃ and 50 ℃ under normal pressure, and the solution is cooled to room temperature before the injection water is added to the full amount in the step S5.
S6: respectively filtering by using 0.45um organic filter element and 0.22um organic filter element; after the visible foreign matters in the liquid medicine are inspected to be qualified, the liquid medicine is conveyed to a filling and sealing station for filling and sealing;
s7: sterilizing and inspecting by lamp to obtain the flunixin meglumine injection.
Table 3 shows the results of the damage experiment of the flunixin meglumine injection prepared in example 3 of the present invention, and as shown in table 3, the flunixin meglumine injection prepared in example 3 of the present invention has good product stability, and can maintain stability for at least eighteen months under high temperature, illumination or freezing conditions.
Table 3: example 3 results of the Damage test of Flunixin meglumine injection prepared
The invention ensures the product quality and prolongs the quality guarantee period by adding the ethanol, and the produced flunixin meglumine injection is still qualified after being stored for more than two years, ensures that all indexes of the product are qualified in the effective period, solves the problem of precipitation and obtains satisfactory results.
Although the present invention has been described with reference to the preferred embodiments, it should be understood that the scope of the present invention is not limited thereto, and those skilled in the art will appreciate that various changes and modifications can be made without departing from the spirit and scope of the present invention.
Claims (8)
1. A production method of flunixin meglumine injection is characterized by comprising the following steps:
s1: adding 10-40% of water for injection and 10-30% of ethanol into a preparation container, and stirring;
s2: taking a proper amount of water for injection, and dissolving a predetermined amount of anhydrous sodium sulfite;
s3: adding a predetermined amount of flunixin meglumine to the preparation container to be completely dissolved, and then adding a predetermined amount of anhydrous sodium sulfite solution dissolved in the step S2;
s4: adding water for injection to a predetermined preparation volume, and adjusting the pH value to be 8.2-8.8;
s5: adding water for injection to full volume, and stirring for a certain time;
s6: filtering and encapsulating;
s7: sterilizing and performing light inspection to obtain the flunixin meglumine injection;
in the step S1, the volume ratio of the added ethanol to the flunixin meglumine injection is between 180 and 220 ml/L;
in the step S2, the volume ratio of the added anhydrous sodium sulfite to the flunixin meglumine injection is between 1 and 3 g/L;
in the step S3, the volume ratio of the added flunixin meglumine to the flunixin meglumine injection is between 80 and 90 g/L;
in step S4, the pH is adjusted using ethanolamine.
2. The method for producing flunixin meglumine injection as claimed in claim 1, wherein: in the step S1, the volume ratio of the added ethanol to the flunixin meglumine injection is 190-210 ml/L.
3. The method for producing flunixin meglumine injection as claimed in any one of claims 1 or 2, wherein: in the step S2, the volume ratio of the added anhydrous sodium sulfite to the flunixin meglumine injection is 2-3 g/L.
4. The method for producing flunixin meglumine injection as claimed in claim 1, wherein: the step S6 specifically includes the following steps:
s61: filtering with 0.45um organic filter element;
s62: filtering with 0.22um organic filter element;
s63: and (5) encapsulating after the detection is qualified.
5. A flunixin meglumine injection is characterized in that: the flunixin meglumine injection comprises the following components in parts by weight: ethanol, 180 and 220 ml/L; 80-90g/L of flunixin meglumine; 1-3g/L of anhydrous sodium sulfite, wherein the solvent of the flunixin meglumine injection is water for injection.
6. The flunixin meglumine injection of claim 5, wherein: in the flunixin meglumine injection, the content of ethanol is between 190 and 210 ml/L.
7. The flunixin meglumine injection of claim 6, wherein: the content of ethanol in the flunixin meglumine injection is 200 ml/L.
8. The flunixin meglumine injection of any one of claims 6-7, wherein: the content of anhydrous sodium sulfite in the flunixin meglumine injection is 2 g/L.
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| CN201710498945.4A CN107375201B (en) | 2017-06-27 | 2017-06-27 | Flunixin meglumine injection and production method thereof |
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