CN108056229A - A kind of preparation method of stabiliser compositions applied in antibiotic solution - Google Patents
A kind of preparation method of stabiliser compositions applied in antibiotic solution Download PDFInfo
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- CN108056229A CN108056229A CN201711492518.1A CN201711492518A CN108056229A CN 108056229 A CN108056229 A CN 108056229A CN 201711492518 A CN201711492518 A CN 201711492518A CN 108056229 A CN108056229 A CN 108056229A
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- antibiotic solution
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23K—FODDER
- A23K20/00—Accessory food factors for animal feeding-stuffs
- A23K20/10—Organic substances
- A23K20/116—Heterocyclic compounds
- A23K20/132—Heterocyclic compounds containing only one nitrogen as hetero atom
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23K—FODDER
- A23K20/00—Accessory food factors for animal feeding-stuffs
- A23K20/10—Organic substances
- A23K20/105—Aliphatic or alicyclic compounds
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23K—FODDER
- A23K20/00—Accessory food factors for animal feeding-stuffs
- A23K20/10—Organic substances
- A23K20/163—Sugars; Polysaccharides
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23K—FODDER
- A23K20/00—Accessory food factors for animal feeding-stuffs
- A23K20/20—Inorganic substances, e.g. oligoelements
- A23K20/22—Compounds of alkali metals
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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
- A61K47/12—Carboxylic acids; Salts or anhydrides 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
- A61K47/06—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
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
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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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Abstract
The present invention relates to a kind of preparation methods of the stabiliser compositions applied in antibiotic solution, and its composition component and its ratio of weight and number are：15 30 parts of PVPK30,15 20 parts of sodium sulfite, 10 15 parts of sodium pyrosulfite, 10 30 parts of sodium Diacetate, 10 20 parts of citric acid, 10 20 parts of sorbierite.The of the invention oxidation for effectively preventing antibiotic solution preparation from occurring in the process in storage, discoloration, precipitation, corruption, situations such as potency is unstable；It is small with adding proportion simultaneously, easy to use, cheap, the features such as easily storage；The present composition has good stabilization to antibiotic pharmaceutical solutions at low temperatures and high temperatures from the influence of PH, acid-base value, concentration and temperature and environmental microorganism；Keep potency constant within the shelf-life simultaneously.
Description
Technical field
The invention belongs to feed additive field, especially a kind of stabiliser compositions being applied in antibiotic solution
Preparation method.
Background technology
With the continuous upgrading of national standard, many antibiotic products gradually change from pulvis to oral solution, mouth
It is more and more common on the market to take the oral solution formulations such as liquid, suspension, it is easy to use,.Favored very much at present.But solution
Although there are many type benefit, hyperconcetration, the half-life period of drug and blood concentration or even the crystalline substance for changing many drugs are added
Type, then stability problem is than more prominent.For example titer of antibodies declines before the deadline, changes colour, and decomposes, hydrolysis, precipitation point
Situations such as layer, failure, is visible repeatedly.It with the continuous promotion of technique, takes a favorable turn at present, but it is to work as to invent a kind of stabilizer
Business is anxious, and this product is not only suitable for aqueous products and can be used for fat-soluble product again, easy to use, cheap.
The content of the invention
An object of the present invention is to provide a kind of stabiliser compositions applied in antibiotic solution, said composition tool
There is situations such as oxidation of the invention for effectively preventing antibiotic solution preparation from occurring in the process in storage, discoloration, potency is unstable；Its
It is small with adding proportion, it is easy to use, it is cheap, the features such as easily storage；The present composition is from PH, acid-base value, concentration
And the influence of temperature and environmental microorganism, there is good stabilization to antibiotic pharmaceutical solutions at low temperatures and high temperatures；Together
When within the shelf-life keep potency it is constant.
The second object of the present invention is to provide a kind of preparation method of the stabiliser compositions applied in antibiotic solution.
The present invention is achieved through the following technical solutions：
A kind of stabiliser compositions applied in antibiotic solution, component and its ratio of weight and number are：
Moreover, the component of the composition and its optimal ratio of weight and number are：
A kind of preparation method of stabiliser compositions applied in antibiotic solution, it is characterised in that：Preparation method
Step is：
(1) special PVPK30, sodium sulfite, sodium pyrosulfite, sodium Diacetate, citric acid, mountain are weighed respectively according to weight proportion
Pears alcohol carries out 100 mesh sievings, and oversize is crushed and crosses 100 mesh sieves；The requirement of whole process environment temperature is controlled at 18-25 DEG C,
Humid control is below 50%；
(2), by the PVPK30 after sieving, sodium sulfite, sodium pyrosulfite, sodium Diacetate, citric acid, sorbierite is respectively put into
When being dried under reduced pressure that 45 degree of dryings 5 are small in case；
(3), by dried PVPK30, sodium sulfite, sodium pyrosulfite, sodium Diacetate, citric acid puts after sorbierite mixing
Enter in three-dimensional mixer mixing tank, uniformly mixing 35 minutes is to get to a kind of finished product of stabiliser compositions.
Advantages of the present invention and advantageous effect are：
1. the additive has the oxidation that the present invention effectively prevents antibiotic solution preparation from occurring in the process in storage, become
Situations such as color, potency is unstable；
2. this product adding proportion is small, easy to use, cheap, the features such as easily storage；
3. the present composition is from the influence of PH, acid-base value, concentration and temperature and environmental microorganism, in low temperature and high temperature
Under have good stabilization to antibiotic pharmaceutical solutions；Keep potency constant within the shelf-life simultaneously.
Specific embodiment
The present invention is described in further detail by following embodiment.It should be noted that：Following embodiments are illustrative, are not
It is limited, it is impossible to limit protection scope of the present invention with following embodiments.
PVPK30 in the present invention, sodium sulfite, sodium pyrosulfite, sodium Diacetate, citric acid, sorbierite can be in cities
It is commercially available on.
Embodiment 1
A kind of stabiliser compositions applied in antibiotic solution, the component and its weight of its composition are respectively：
PVPK3020 parts, 15 parts of sodium sulfite, 15 parts of sodium pyrosulfite, 15 parts of sodium Diacetate, 20 parts of citric acid, 15 parts of sorbierite.
(1) special PVPK30, sodium sulfite, sodium pyrosulfite, sodium Diacetate, citric acid, mountain are weighed respectively according to weight proportion
Pears alcohol carries out 100 mesh sievings, and oversize is crushed and crosses 100 mesh sieves；The requirement of whole process environment temperature is controlled at 18-25 DEG C,
Humid control is below 50%；
(2), by the PVPK30 after sieving, sodium sulfite, sodium pyrosulfite, sodium Diacetate, citric acid, sorbierite is respectively put into
When being dried under reduced pressure that 45 degree of dryings 5 are small in case；
(3), by dried PVPK30, sodium sulfite, sodium pyrosulfite, sodium Diacetate, citric acid puts after sorbierite mixing
Enter in three-dimensional mixer mixing tank, uniformly mixing 35 minutes is to get to a kind of finished product of stabiliser compositions.
Embodiment 2
A kind of application of stabiliser compositions in antibiotic solution additive, component and its weight difference of additive
For：20 parts of PVPK30,25 parts of sodium sulfite, 15 parts of sodium pyrosulfite, 15 parts of sodium Diacetate, 20 parts of citric acid, 5 parts of sorbierite.
The step of its preparation method, is the same as embodiment 1.
Embodiment 3
A kind of application in antibiotic solution additive of stabiliser compositions, the component of feed addictive and its again
Amount is respectively：10 parts of PVPK30,15 parts of sodium sulfite, 15 parts of sodium pyrosulfite, 25 parts of sodium Diacetate, 20 parts of citric acid, sorb
15 parts of alcohol.
The step of its preparation method, is the same as embodiment 1.
Clinical practice
It tests (one)
This product is added according to 0.5% ratio in formula as below, the homemade neomycin sulphate solution of company, analyzes guarantee value：
Neomycin >=20,000,000 units/ml；Tilmicosin phosphate solution analyzes guarantee value：Tilmicosin >=200mg/ml；Thiocyanic acid is red
Mycin solution analyzes guarantee value：Erythromycin >=5,000,000 units/ml；Dimension is according to normal production technology, hot and humid (35
DEG C, humidity 75%) time observation product different under environment stability, and record following form；
It tests (two)：It is not added with the same money antibiotic product of present component；It is as a result as follows with the experimental condition of experiment 1：
Conclusion：It can be seen that adding proportion of the present invention is small from experiment 1, effect greatly, to antibiotic solution product not only face
It is colour-stable, and without precipitation, each component content of raw material does not decline, therefore the present invention can be produced as stabiliser compositions in liquid antibiotic
It is applied in product preparation.
Claims (3)
1. a kind of stabiliser compositions applied in antibiotic solution, it is characterised in that：The component and its weight of said composition
Portion rate is：
2. a kind of stabiliser compositions applied in antibiotic solution according to claim 1, it is characterised in that：The group
The component of conjunction object and its optimal ratio of weight and number are：
3. a kind of a kind of preparation method of stabiliser compositions applied in antibiotic solution as described in claim 1,
It is characterized in that：The step of preparation method is：
(1) special PVPK30, sodium sulfite, sodium pyrosulfite, sodium Diacetate, citric acid, sorbierite are weighed respectively according to weight proportion
100 mesh sievings are carried out, oversize is crushed and cross 100 mesh sieves；The requirement control of whole process environment temperature is at 18-25 DEG C, humidity
Control is below 50%；
(2), by the PVPK30 after sieving, sodium sulfite, sodium pyrosulfite, sodium Diacetate, citric acid, sorbierite is respectively put into decompression
When 45 degree of dryings 5 are small in drying box；
(3), by dried PVPK30, sodium sulfite, sodium pyrosulfite, sodium Diacetate, citric acid is put into three after sorbierite mixing
Tie up in mixer mixing tank, uniformly mixing 35 minutes to get to a kind of stabiliser compositions applied in antibiotic solution into
Product.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201711492518.1A CN108056229A (en) | 2017-12-30 | 2017-12-30 | A kind of preparation method of stabiliser compositions applied in antibiotic solution |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201711492518.1A CN108056229A (en) | 2017-12-30 | 2017-12-30 | A kind of preparation method of stabiliser compositions applied in antibiotic solution |
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| Publication Number | Publication Date |
|---|---|
| CN108056229A true CN108056229A (en) | 2018-05-22 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201711492518.1A Withdrawn CN108056229A (en) | 2017-12-30 | 2017-12-30 | A kind of preparation method of stabiliser compositions applied in antibiotic solution |
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| Country | Link |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113197862A (en) * | 2021-04-16 | 2021-08-03 | 山东亚康药业股份有限公司 | High-content erythromycin thiocyanate soluble powder and preparation method thereof |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1882349A (en) * | 2003-11-14 | 2006-12-20 | 千寿制药株式会社 | Aqueous solution preparation containing aminoglycoside antibiotic and bromfenac |
| CN101045063A (en) * | 2006-03-28 | 2007-10-03 | 广州朗圣药业有限公司 | Clarithromycin water soluber preparation for injection use |
| CN101199855A (en) * | 2006-12-13 | 2008-06-18 | 天津药业研究院有限公司 | Skinniness hormone packing matter water solution and application thereof |
| CN102145164A (en) * | 2010-12-16 | 2011-08-10 | 深圳市健元医药科技有限公司 | IAPP (Islet Amyloid Polypeptide) analog injection with better stability |
| CN103142616A (en) * | 2012-11-26 | 2013-06-12 | 凌莉 | Pharmaceutical composition for improving pharmaceutical stability |
-
2017
- 2017-12-30 CN CN201711492518.1A patent/CN108056229A/en not_active Withdrawn
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1882349A (en) * | 2003-11-14 | 2006-12-20 | 千寿制药株式会社 | Aqueous solution preparation containing aminoglycoside antibiotic and bromfenac |
| CN101045063A (en) * | 2006-03-28 | 2007-10-03 | 广州朗圣药业有限公司 | Clarithromycin water soluber preparation for injection use |
| CN101199855A (en) * | 2006-12-13 | 2008-06-18 | 天津药业研究院有限公司 | Skinniness hormone packing matter water solution and application thereof |
| CN102145164A (en) * | 2010-12-16 | 2011-08-10 | 深圳市健元医药科技有限公司 | IAPP (Islet Amyloid Polypeptide) analog injection with better stability |
| CN103142616A (en) * | 2012-11-26 | 2013-06-12 | 凌莉 | Pharmaceutical composition for improving pharmaceutical stability |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113197862A (en) * | 2021-04-16 | 2021-08-03 | 山东亚康药业股份有限公司 | High-content erythromycin thiocyanate soluble powder and preparation method thereof |
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Application publication date: 20180522 |
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