CN113398066A - Levofloxacin hydrochloride and sodium chloride injection for pets and preparation method thereof - Google Patents
Levofloxacin hydrochloride and sodium chloride injection for pets and preparation method thereof Download PDFInfo
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- CN113398066A CN113398066A CN202110750072.8A CN202110750072A CN113398066A CN 113398066 A CN113398066 A CN 113398066A CN 202110750072 A CN202110750072 A CN 202110750072A CN 113398066 A CN113398066 A CN 113398066A
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- sodium chloride
- levofloxacin hydrochloride
- injection
- water
- pets
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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
- A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
- A61K31/5375—1,4-Oxazines, e.g. morpholine
- A61K31/5383—1,4-Oxazines, e.g. morpholine ortho- or peri-condensed with heterocyclic ring systems
-
- 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
- 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
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Dermatology (AREA)
- Communicable Diseases (AREA)
- Oncology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Inorganic Chemistry (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention discloses a levofloxacin hydrochloride and sodium chloride injection for pets and a preparation method thereof, and the injection mainly comprises the following components in percentage by weight: 0.1 percent of levofloxacin hydrochloride and 0.9 percent of sodium chloride. The levofloxacin hydrochloride indications in the invention are the following moderate and severe infections caused by sensitive bacteria: respiratory infections: acute bronchitis, acute episode of chronic bronchitis, diffuse bronchitis, bronchiectasis complicated with infection, pneumonia, and tonsillitis (peritonsillar abscess). Urinary system infection: pyelonephritis, complicated urinary tract infection, etc. Infection of skin soft tissue: infectious impetigo, cellulitis, lymphangitis, subcutaneous abscess, perianal abscess, etc.; the invention improves the stability of levofloxacin hydrochloride preparation and the safety of medicine use on the premise of not adding other reagents, and makes up the defects of the prior art.
Description
Technical Field
The invention relates to the technical field of animal medicine, in particular to a levofloxacin hydrochloride and sodium chloride injection for pets and a preparation method thereof.
Background
The main component of the levofloxacin hydrochloride sodium chloride injection is levofloxacin hydrochloride, the chemical name of the levofloxacin hydrochloride is (S) - (-) -9-fluorine-2, 3-dihydro-3-methyl-10- (4-methyl-1-piperazinyl) -7-oxygen-7H-pyrido [1,2,3-de ] - [1,4] benzoxazine-6-carboxylic acid hydrochloride hydrate, and the levofloxacin hydrochloride sodium chloride injection is light green or yellow green clear liquid. The indications are the following moderate and severe infections caused by sensitive bacteria: respiratory infections: acute bronchitis, acute episode of chronic bronchitis, diffuse bronchitis, bronchiectasis complicated with infection, pneumonia, and tonsillitis (peritonsillar abscess). Urinary system infection: pyelonephritis, complicated urinary tract infection, etc. Infection of skin soft tissue: infectious impetigo, cellulitis, lymphangitis, subcutaneous abscess, perianal abscess, etc.
However, the conventional preparation process may include preservatives and stabilizers, thereby affecting the stability of the product.
Disclosure of Invention
The invention aims to provide a levofloxacin hydrochloride sodium chloride injection for pets and a preparation method thereof aiming at the defects and shortcomings of the prior art.
In order to achieve the purpose, the invention adopts the technical scheme that: the levofloxacin hydrochloride and sodium chloride injection for pets is characterized by mainly comprising the following components in percentage by weight:
levofloxacin hydrochloride 0.1%
0.9 percent of sodium chloride
The preparation method of the levofloxacin hydrochloride and sodium chloride injection for pets is characterized by comprising the following steps:
s1, adopting a concentration-dilution method: weighing sodium chloride, adding 60% of water for injection, stirring for dissolving, weighing levofloxacin hydrochloride, adding the levofloxacin hydrochloride into a sodium chloride solution, adding 55-65 ℃ of water for injection till 30% of the prepared volume is stirred for dissolving, adding 0.005% of medicinal carbon slurry, stirring for adsorbing for 10 minutes, filtering for decarbonization, conveying to a diluted preparation post, adding water for injection to full dose, performing circulating reflux for 20 minutes, and filtering;
s2, pretreatment of medicinal charcoal: preparing activated carbon into activated carbon slurry with 80 deg.C water for injection, adding medicinal liquid, stirring and adsorbing for 10-20min to uniformly disperse medicinal carbon in the medicinal liquid;
s3, adjusting the pH value: selecting 1mol/L hydrochloric acid solution to adjust the pH value, adding 40-50ml of 1mol/L hydrochloric acid solution during dilution, and adjusting the pH value of the liquid medicine to 4.5-5.5;
s4, water bath type sterilization: adopts a sterilization mode of high temperature of 121 ℃ and 12 min.
The invention has the beneficial effects that:
the preparation method is simple, and no preservative or stabilizer is added in the production process, so that the stability and the qualification rate of the product quality are improved.
Detailed Description
The following examples further illustrate the invention.
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is further described in detail with reference to the following embodiments. It should be understood that the detailed description and specific examples, while indicating the invention, are intended for purposes of illustration only and are not intended to limit the scope of the invention.
Example 1
A preparation method of levofloxacin hydrochloride and sodium chloride injection for pets comprises the following steps:
s1, adopting a concentration-dilution method: weighing sodium chloride, adding 60% of water for injection, stirring for dissolving, weighing levofloxacin hydrochloride, adding the levofloxacin hydrochloride into a sodium chloride solution, adding 55-65 ℃ of water for injection till 30% of the prepared volume is stirred for dissolving, adding 0.005% of medicinal carbon slurry, stirring for adsorbing for 10 minutes, filtering for decarbonization, conveying to a diluted preparation post, adding water for injection to full dose, performing circulating reflux for 20 minutes, and filtering;
s2, pretreatment of medicinal charcoal: preparing activated carbon into activated carbon slurry with 80 deg.C water for injection, adding medicinal liquid, stirring and adsorbing for 10-20min to uniformly disperse medicinal carbon in the medicinal liquid;
s3, adjusting the pH value: selecting 1mol/L hydrochloric acid solution to adjust the pH value, adding 40-50ml of 1mol/L hydrochloric acid solution during dilution, and adjusting the pH value of the liquid medicine to 4.5-5.5;
s4, water bath type sterilization: adopts a sterilization mode of high temperature of 121 ℃ and 12 min.
After the process is adopted, the prepared levofloxacin hydrochloride sodium chloride injection for pets has the following characteristics:
| Time | levofloxacin content (%) | Sodium chloride content (%) |
| Standard of merit | 90.0％-110.0％ | 95.0％-107.0％ |
| Day 0 | 103.2％ | 102.1％ |
| Accelerating for 1 month | 102.4％ | 101.9％ |
| Accelerated for 2 months | 101.6％ | 101.1％ |
| Accelerated for 3 months | 101.4％ | 100.5％ |
| Accelerated for 6 months | 100.5％ | 100.6％ |
| Long term for 3 months | 102.9％ | 102.3％ |
| Long term of 6 months | 102.6％ | 102.0％ |
As can be seen from the table, the levofloxacin hydrochloride sodium chloride injection for pets prepared by the invention has good stability.
The above description is only for the purpose of illustrating the technical solutions of the present invention and not for the purpose of limiting the same, and other modifications or equivalent substitutions made by those skilled in the art to the technical solutions of the present invention should be covered within the scope of the claims of the present invention without departing from the spirit and scope of the technical solutions of the present invention.
Claims (2)
1. The levofloxacin hydrochloride and sodium chloride injection for pets is characterized by mainly comprising the following components in percentage by weight:
levofloxacin hydrochloride 0.1%
0.9 percent of sodium chloride.
2. A method for preparing levofloxacin hydrochloride sodium chloride injection for pets according to claim 1, which comprises the following steps:
s1, adopting a concentration-dilution method: weighing sodium chloride, adding 60% of water for injection, stirring for dissolving, weighing levofloxacin hydrochloride, adding the levofloxacin hydrochloride into a sodium chloride solution, adding 55-65 ℃ of water for injection till 30% of the prepared volume is stirred for dissolving, adding 0.005% of medicinal carbon slurry, stirring for adsorbing for 10 minutes, filtering for decarbonization, conveying to a diluted preparation post, adding water for injection to full dose, performing circulating reflux for 20 minutes, and filtering;
s2, pretreatment of medicinal charcoal: preparing activated carbon into activated carbon slurry with 80 deg.C water for injection, adding medicinal liquid, stirring and adsorbing for 10-20min to uniformly disperse medicinal carbon in the medicinal liquid;
s3, adjusting the pH value: selecting 1mol/L hydrochloric acid solution to adjust the pH value, adding 40-50ml of 1mol/L hydrochloric acid solution during dilution, and adjusting the pH value of the liquid medicine to 4.5-5.5;
s4, water bath type sterilization: adopts a sterilization mode of high temperature of 121 ℃ and 12 min.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202110750072.8A CN113398066A (en) | 2021-07-02 | 2021-07-02 | Levofloxacin hydrochloride and sodium chloride injection for pets and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202110750072.8A CN113398066A (en) | 2021-07-02 | 2021-07-02 | Levofloxacin hydrochloride and sodium chloride injection for pets and preparation method thereof |
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| Publication Number | Publication Date |
|---|---|
| CN113398066A true CN113398066A (en) | 2021-09-17 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN202110750072.8A Pending CN113398066A (en) | 2021-07-02 | 2021-07-02 | Levofloxacin hydrochloride and sodium chloride injection for pets and preparation method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN116831986A (en) * | 2023-09-01 | 2023-10-03 | 成都医路康医学技术服务有限公司 | Levofloxacin sodium chloride injection and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103479522A (en) * | 2013-09-25 | 2014-01-01 | 海南华拓天涯制药有限公司 | Method for preparing levofloxacin hydrochloride sodium chloride injection |
-
2021
- 2021-07-02 CN CN202110750072.8A patent/CN113398066A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103479522A (en) * | 2013-09-25 | 2014-01-01 | 海南华拓天涯制药有限公司 | Method for preparing levofloxacin hydrochloride sodium chloride injection |
Non-Patent Citations (1)
| Title |
|---|
| 钟意分: "盐酸左氧氟沙星氯化钠注射液", 《HTTPS://WWW.DOC88.COM/P-6087457458976.HTML》 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN116831986A (en) * | 2023-09-01 | 2023-10-03 | 成都医路康医学技术服务有限公司 | Levofloxacin sodium chloride injection and preparation method thereof |
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Application publication date: 20210917 |