CN107028878A - 30% lincomycin hydrochloride injection and preparation method thereof - Google Patents
30% lincomycin hydrochloride injection and preparation method thereof Download PDFInfo
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- CN107028878A CN107028878A CN201710289993.2A CN201710289993A CN107028878A CN 107028878 A CN107028878 A CN 107028878A CN 201710289993 A CN201710289993 A CN 201710289993A CN 107028878 A CN107028878 A CN 107028878A
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- Prior art keywords
- lincomycin
- lincomycin hydrochloride
- recipe quantity
- hydrochloride injection
- 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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
- A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
- A61K31/7056—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing five-membered rings with nitrogen as a ring hetero atom
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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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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Dermatology (AREA)
- Molecular Biology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
30% lincomycin hydrochloride injection disclosed by the invention, it is with C18H34N2O6S is counted, 10ml：3g.The preparation method of 30% lincomycin hydrochloride injection of the present invention, comprises the following steps：Take the water for injection of recipe quantity 50%, add the phenmethylol stirring and dissolving of recipe quantity, add the Lincomycin Hydrochloride dissolving of recipe quantity, benefit injects water to total amount, with 0.22um filter core refined filtrations, and by flowing steam 100 DEG C sterilize 30 minutes, produce.The present invention is bacteriostatic agent, has bactericidal action to extremely sensitive bacterium during high concentration.It dramatically increases bactericidal action of the lincomycin to sensitive bacteria by increasing concentration；Pass through final sterilization production technology, it is ensured that medicine is sterile, and do not influence medicine stability, it is ensured that drug effect.Clinically the present invention is usually used in gram positive bacteria infection, particularly penicillin resistant and the bacterium infection sensitive to lincomycin, such as staphylococosis, streptococcosis, mastitis, it can also be used to swine enzootic pneumonia caused by pig treponematosis and mycoplasma infection.
Description
Technical field
The present invention relates to technical field of animal remedy preparation, more particularly to 30% lincomycin hydrochloride injection and its preparation side
Method.
Background technology
Lincomycin (lincomycin), also known as lincomycinum, are that the elite stand obtained in strepto- bacteria culture fluid can amine
Alkaline antibiotic.The disease started for treating dog and cat for 1967, is respectively used to chicken in 1970,1976 and pig is somatotrophic
Feed addictive, lincomycin injection in 1979 starts the disease (Jim, 2009) for treating pig.Lincomycin acts on machine
Manage and combined for the ribosomes 50S subunits with sensitive bacteria, suppress the reaction of peptidyl transferase, block peptidyl to connect to be formed and mRNA
Move and suppress bacterioprotein synthesis, bacterium is produced and suppressed or killing action.Lincomycin is to most of gram-positive bacterias
As staphylococcus aureus (including penicillin resistant bacterial strain), streptococcus (except enterococcus faecalis), bacillus anthracis, erysipelothrix porci and
Some mycoplasmas (mycoplasma hyopneumoniae, mycoplasma hyorhinis, pig mycoplasma fluid), Leptospira, dysentery Brachyspira etc.
It is sensitive to lincomycin.Part anaerobic bacteria is also sensitive to it, including Fusobacterium, peptostreptococcus, clostridium tetani, aerogenesis
Capsular clostridium and most of actinomyces etc..The Lincomycin Hydrochloride of approved is used for the animals such as pig, ox, dog, cat both at home and abroad at present,
Formulation is mainly：Soluble powder (5%, 10%), parenteral solution are (with C18H34N2O6S is counted, 10ml：0.6g、10ml：1.5g、2ml：
0.6g、10ml：0.3g、10ml：1g).
The content of the invention,
One of technical problems to be solved by the invention are the weak point present in existing Lincomycin Hydrochloride
And a kind of 30% lincomycin hydrochloride injection is provided.
The two of the technical problems to be solved by the invention are the preparation for providing above-mentioned 30% lincomycin hydrochloride injection
Method.
Technical scheme to be solved by this invention can be achieved through the following technical solutions：
A kind of 30% lincomycin hydrochloride injection, it is with C18H34N2O6S is counted, 10ml：3g, its pH value is 3.5~5.
The preparation method of above-mentioned 30% lincomycin hydrochloride injection, it takes the water for injection of recipe quantity 50% first, plus
Enter the phenmethylol stirring and dissolving of recipe quantity, add the Lincomycin Hydrochloride dissolving of recipe quantity, benefit injects water to total amount, used
0.22um filter core refined filtrations, and by the sterilizing 30 minutes of 100 DEG C of flowing steam, produce.
The present invention is bacteriostatic agent, has bactericidal action to extremely sensitive bacterium during high concentration.It is dramatically increased by increasing concentration
Bactericidal action of the lincomycin to sensitive bacteria；Pass through final sterilization production technology, it is ensured that medicine is sterile, and do not influence drug substance stable
Property, it is ensured that drug effect.
Clinically the present invention be usually used in gram positive bacteria infection, particularly penicillin resistant and to sensitive thin of lincomycin
Bacterium infects, such as staphylococosis, streptococcosis, mastitis, it can also be used to caused by pig treponematosis and mycoplasma infection
Swine enzootic pneumonia.Its cure rate reaches more than 80%.
Embodiment
It is described in detail technical scheme below in conjunction with embodiment, but following embodiments are only pair
The elaboration of the present invention, will not constitute limitations on claims.
A kind of 30% lincomycin hydrochloride injection of the present invention, it is with C18H34N2O6S is counted, 10ml：3g, its pH value is
3.5~5.
The preparation method of above-mentioned 30% lincomycin hydrochloride injection, it takes the water for injection of recipe quantity 50% first, plus
Enter the phenmethylol stirring and dissolving of recipe quantity, add the Lincomycin Hydrochloride dissolving of recipe quantity, benefit injects water to total amount, used
0.22um filter core refined filtrations, and by the sterilizing 30 minutes of 100 DEG C of flowing steam, produce.
Stability study
1st, strong shadow rings experiment
30% lincomycin hydrochloride injection of Example 1 to 3, is 4500L in illuminationX±500LXUnder the conditions of place 10
My god, in the 5th, investigate the relevant items such as character, content within the 10th day, the testing result with 0 day is contrasted, and investigates the stability of parenteral solution
Situation, conclusion such as table 1 below：
Table the last 1 shadow rings experiment
2nd, accelerated test
Accelerated test is placed 6 months, at first in 40 DEG C ± 2 DEG C of temperature under conditions of relative humidity 75% ± 5%
The quality index situation of change of high spot review project, is as a result shown in as defined in each formulation of the sampling detection of the moon, the 3rd month, the 6th month
Table 2 below：
The accelerated test result of table 2
3. long-term stable experiment
Long term test is placed 18 months under conditions of 25 DEG C ± 2 DEG C of temperature, relative humidity 60% ± 10%, respectively at 0
Individual month, 3 months, 6 months, 12 months, 18 months is detected by stability high spot reviews project, as a result see the table below 3.
The long-term test results of table 3
Brief summary：
From above-mentioned table 1-3, lincomycin hydrochloride injection combination stability experiment prepared by the present invention, its preparation is steady
It is qualitative good, quality controllable, with good application value.
Clinical test
The pig of different pig farm natural occurrences is chosen, after diagnosing, following symptom is respectively provided with：There is high fever 40-42.5 degree, it is obstinate
Property high fever；Spiritual depressed, anorexia；Skin many places erythema, purple plague purpura, severe patient turns blue；Cough, breathes, abdominal respiration；
Enlargement of lymph nodes, palpebral edema, arthrocele；Product heap is shaken, and has a nervous symptoms, or sleeping the symptoms such as shape stroke of swimming.
1st, 30% lincomycin hydrochloride injection embodiment 1 to 3 of the invention is common with commercially available lincomycin hydrochloride injection
Preparation 1 is (with C18H34N2O6S is counted, 10ml：3g), commercially available lincomycin hydrochloride injection ordinary preparation 2 is (with C18H34N2O6S is counted,
10ml：3g), commercially available lincomycin hydrochloride injection ordinary preparation 3 is (with C18H34N2O6S is counted, 10ml：Drug effect 10g) compares.
Packet is respectively with commercially available lincomycin hydrochloride injection ordinary preparation 1 (with C18H34N2O6S is counted, 10ml：3g), it is commercially available
Lincomycin hydrochloride injection ordinary preparation 2 is (with C18H34N2O6S is counted, 10ml：3g), commercially available lincomycin hydrochloride injection is common
Preparation 3 is (with C18H34N2O6S is counted, 10ml：1g) treated with 30% lincomycin hydrochloride injection embodiment 1 to 3 of the invention
Compare, therapeutic modality is referring to table 4 below：
The test pig of table 4 is grouped and handled
Start medication within 15 days, the death rate of each group pig, cure rate, effective percentage see the table below 5：
The treatment results of table 5
From above-mentioned experiment, 30% lincomycin hydrochloride injection drug effect of the invention is significantly better than commercially available 30%,
10% lincomycin hydrochloride injection.
Claims (2)
1.30% lincomycin hydrochloride injection, it is characterised in that with C18H34N2O6S is counted, 10ml：3g.
2. the preparation method of 30% lincomycin hydrochloride injection described in claim 1, it takes the note of recipe quantity 50% first
Penetrate and use water, add the phenmethylol stirring and dissolving of recipe quantity, add the Lincomycin Hydrochloride dissolving of recipe quantity, add water for injection
To total amount, with 0.22um filter core refined filtrations, and by flowing steam 100 DEG C sterilize 30 minutes, produce.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN201710289993.2A CN107028878A (en) | 2017-04-27 | 2017-04-27 | 30% lincomycin hydrochloride injection and preparation method thereof |
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| CN201710289993.2A CN107028878A (en) | 2017-04-27 | 2017-04-27 | 30% lincomycin hydrochloride injection and preparation method thereof |
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| CN107028878A true CN107028878A (en) | 2017-08-11 |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109528639A (en) * | 2018-12-24 | 2019-03-29 | 江西润泽药业有限公司 | A method of being used to prepare compound lincomycin hydrochloride injection |
| CN111855619A (en) * | 2020-07-09 | 2020-10-30 | 北京服装学院 | Surface plasma resonance sensing chip, preparation method thereof and sensing equipment |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102475677A (en) * | 2010-11-22 | 2012-05-30 | 华北制药股份有限公司 | Preparation method of lincomycin hydrochloride injection |
| CN103830172A (en) * | 2014-03-05 | 2014-06-04 | 刘飞飞 | Preparation method of lincomycin hydrochloride injection |
| CN104666243A (en) * | 2015-03-19 | 2015-06-03 | 上海旭东海普药业有限公司 | Preparation method for improving quality of lincomycin hydrochloride injection |
-
2017
- 2017-04-27 CN CN201710289993.2A patent/CN107028878A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102475677A (en) * | 2010-11-22 | 2012-05-30 | 华北制药股份有限公司 | Preparation method of lincomycin hydrochloride injection |
| CN103830172A (en) * | 2014-03-05 | 2014-06-04 | 刘飞飞 | Preparation method of lincomycin hydrochloride injection |
| CN104666243A (en) * | 2015-03-19 | 2015-06-03 | 上海旭东海普药业有限公司 | Preparation method for improving quality of lincomycin hydrochloride injection |
Non-Patent Citations (2)
| Title |
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| 国家药典委员会编: "《中华人民共和国药典 2015年版二部》", 30 June 2015, 中国医药科技出版社 * |
| 道客巴巴: "盐酸林可霉素注射液批文", 《道客巴巴HTTP://WWW.DOC88.COM/P-1428507140458.HTML》 * |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109528639A (en) * | 2018-12-24 | 2019-03-29 | 江西润泽药业有限公司 | A method of being used to prepare compound lincomycin hydrochloride injection |
| CN111855619A (en) * | 2020-07-09 | 2020-10-30 | 北京服装学院 | Surface plasma resonance sensing chip, preparation method thereof and sensing equipment |
| CN111855619B (en) * | 2020-07-09 | 2023-05-12 | 北京服装学院 | Surface plasma resonance sensing chip, preparation method thereof and sensing equipment |
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