CN108670956A - A kind of amoxicillin soluble powder and preparation method thereof - Google Patents
A kind of amoxicillin soluble powder and preparation method thereof Download PDFInfo
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- CN108670956A CN108670956A CN201810722805.5A CN201810722805A CN108670956A CN 108670956 A CN108670956 A CN 108670956A CN 201810722805 A CN201810722805 A CN 201810722805A CN 108670956 A CN108670956 A CN 108670956A
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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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
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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
- A61K31/425—Thiazoles
- A61K31/429—Thiazoles condensed with heterocyclic ring systems
- A61K31/43—Compounds containing 4-thia-1-azabicyclo [3.2.0] heptane ring systems, i.e. compounds containing a ring system of the formula, e.g. penicillins, penems
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/143—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with inorganic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
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- 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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Abstract
The invention belongs to technical field of medicine, a kind of amoxicillin soluble powder and preparation method thereof is disclosed.It is in terms of 100 parts by the sum of parts by weight, parts by weight group becomes:0.01 ~ 50 part of Amoxicillin original powder, 1 ~ 20 part of PVP K30,0.01 ~ 0.5 part of sodium sulfite, 0.01 ~ 1.0 part of EDTA, surplus is mannitol.At room temperature, PVP K30 is dissolved in the in the mixed solvent of absolute ethyl alcohol and petroleum ether composition, is uniformly mixed, obtains system 1;The additive amount of the absolute ethyl alcohol and petroleum ether is respectively 2 ~ 3 times of PVP K30 quality;Amoxicillin original powder is added in system 1, stirs evenly, obtains system 2;System 2 is spray-dried between 10 ~ 50 DEG C to get amoxicillin soluble powder.Amoxicillin soluble powder solubility prepared by the present invention is high and drug substance stable is not degradable after dissolving.
Description
Technical field
The invention belongs to technical field of medicine, it is related to a kind of amoxicillin soluble powder and preparation method thereof.
Background technology
Amoxicillin also known as amoxycillin are that a kind of most common semi-synthetic penicillins wide spectrum beta-lactam is anti-
Raw element, for white or off-white color crystalline powder, taste slight bitter, slightly soluble, does not almost dissolve in ethanol in water.Acid resistance ratio
Ampicillin is strong, relatively stablizes in hydrochloric acid in gastric juice, has 70% or more can be absorbed directly into blood after nonruminant is oral, food can influence
The absorptivity of drug, but the total amount absorbed is not influenced.Amoxicillin bactericidal effect is strong, and the ability of penetration cell wall is also strong.It is mesh
One of preceding widely used oral penicillin, veterinary clinic be usually used in treatment because Escherichia coli, salmonella, streptococcus,
It is infected caused by staphylococcus aureus, pneumococcus etc..
Currently, due to Amoxicillin soluble,very slightly in water, clinically many is all common pulvis spice administration, is not only made
With trouble, it is also easy to the non-uniform phenomenon of drug occur, in addition, for the heavier livestock and poultry of the state of an illness, after feed intake declines, administration
Dosage also can be with decline, and drawback is more.Although soluble powder dosage form can meet is dissolved in water to a certain extent, solubility
It is not high, the doser administration needs of intensive culture instantly cannot be met, in addition, it is degradable to be dissolved in drug after water, final shadow
Ring actual bioavilability.In view of the above-mentioned problems, market needs to prepare a kind of amoxicillin soluble powder agent, meet solubility
Height, and drug substance stable is not degradable after dissolving, process operability is strong, and energy steady production meets marketing demand.
Invention content
The purpose of the present invention is to provide a kind of solubility, the not degradable Amoxicillin of drug substance stable can after high and dissolving
Dissolubility powder and preparation method thereof.
To achieve the above object, the technical solution adopted by the present invention is as follows:
A kind of amoxicillin soluble powder is in terms of 100 parts by the sum of parts by weight, and parts by weight group becomes:Amoxicillin original powder
0.01 ~ 50 part, 1 ~ 20 part of PVP K30,0.01 ~ 0.5 part of sodium sulfite, 0.01 ~ 1.0 part of EDTA, surplus is mannitol.
Further preferably, it is in terms of 100 parts by the sum of parts by weight, parts by weight group becomes:Amoxicillin original powder 10 ~ 40
Part, 5 ~ 15 parts of PVP K30,0.2 ~ 0.4 part of sodium sulfite, 0.2 ~ 0.6 part of EDTA, surplus is mannitol.
Most preferably, it is in terms of 100 parts by the sum of parts by weight, parts by weight group becomes:30 parts of Amoxicillin original powder, povidone
10 parts of K30,0.3 part of sodium sulfite, 0.4 part of EDTA, surplus is mannitol.
Preparation method includes the following steps:
(a), at room temperature, PVP K30 is dissolved in the in the mixed solvent of absolute ethyl alcohol and petroleum ether composition, mixing obtains system
1;The additive amount of the absolute ethyl alcohol and petroleum ether is respectively 2 ~ 3 times of PVP K30 quality(That is the additive amount of absolute ethyl alcohol is poly-
Tie up ketone K30 mass 2 ~ 3 times, the additive amount of petroleum ether are also 2 ~ 3 times of PVP K30 quality);
(b), in system 1 be added Amoxicillin original powder, stir evenly, obtain system 2;
(c), system 2 is spray-dried between 10 ~ 50 DEG C;
(d), by step(c)Resulting material is with sodium sulfite, EDTA and mannitol mixing to get finished product amoxicillin soluble
Powder.
Amoxicillin belongs to penicillin medicine, and drug is thermo-labile, meets water and easily decomposes, the present invention utilizes solid dispersion technology
Principle, by the way that first K30 is dissolved, later be spray-dried after, K30 is precipitated again, and uniform adhesion passes through on drug particle
The affinity interaction of the molecule long-chain of K30, to improve the solubility of drug.
It is in place of the process innovation of the present invention:The hybrid dispersions for selecting absolute ethyl alcohol and petroleum ether, both can be complete
Carrier K30 is dissolved, and physical efficiency can be disperseed at low ambient temperatures, after spraying and quickly volatilized, carrier is quick after losing dispersion
It is precipitated, by drug adhesion, to finally obtain the higher amoxicillin soluble powder of purity.
The present invention has following advantage:
(1), the present invention amoxicillin soluble powder good water solubility, Amoxicillin not soluble in water, which is prepared into, can be dissolved in water
Amoxicillin, and can concentrated compounding use, meet doser administration requirements, be more suitable for intensive, large-scale cultivation;
(2), drug substance stable, bioavilability improves, and drug effect is stronger;
(3), the present invention preparation process simple possible, be convenient for large-scale industrial production, be conducive to marketing.
Specific implementation mode
Below in conjunction with specific embodiment, the present invention will be further described.It should be understood that following embodiment is merely to illustrate this
The range of invention and is not intended to limit the present invention.
A kind of amoxicillin soluble powder, parts by weight composition are shown in Table 1.
Preparation method:
(a), at room temperature, by PVP K30 be dissolved in absolute ethyl alcohol and petroleum ether composition in the mixed solvent, be uniformly mixed, obtain
System 1;The additive amount of the absolute ethyl alcohol and petroleum ether is respectively 3 times of PVP K30 quality, 2 times;
(b), in system 1 be added Amoxicillin original powder, stir evenly, obtain system 2;
(c), system 2 is spray-dried between 30 DEG C;
(d), by step(c)Resulting material and sodium sulfite, EDTA and mannitol mixing, sealed damp-proof storage, sampling, according to standard
After detection is qualified, packing is to get amoxicillin soluble powder in environment of the relative humidity not higher than 30%.
Reference examples 1
Prescription is the same as embodiment 1;Operating process is with embodiment 1 in preparation method, only by step(a)Middle absolute ethyl alcohol and petroleum ether
Amount be changed to 4 times and 1 times of PVP K30 quality respectively.It was found that step(c)After spray drying obtained material viscosity compared with
Greatly, later stage and auxiliary material(Sodium sulfite, EDTA and mannitol)Occurs granularity non-uniform phenomenon when mixing.
Reference examples 2
Prescription is the same as embodiment 1;Operating process is with embodiment 1 in preparation method, only by step(a)Middle absolute ethyl alcohol and petroleum ether
Amount be changed to 1 times and 4 times of PVP K30 quality respectively.
Stability test
The obtained amoxicillin soluble powder appearances of embodiment 1-10 are white or flaxen powder.
The soluble powder product of Example 1-10 carry out respectively test of time, accelerated test, refrigeration experiment, anti-freezing it is steady
Qualitative test observes the stability of soluble powder of the present invention, is confirmed whether there is the appearance of the wild effects such as discoloration, caking, aging.
1, test of time
The soluble powder of Example 1-10 is stored 6 months under the conditions of room temperature natural trend, observation indicate that:Appearance is such as
Just, situations such as no discoloration, caking, aging, occurs, and illustrates that ageing stability is good.
2, accelerated test
The soluble powder of embodiment 1-10 is sub-packed in sack, the acceleration for being placed on 40 DEG C of temperature, relative humidity 70% of sealing
90d is stored in case, is sampled and is observed every 30d.The result shows that:Examine appearance as before after the soluble powder heat storage of embodiment 1-10,
Situations such as no discoloration, caking, aging, occurs, and illustrates that heat storage stability is good.
3, refrigeration experiment
The soluble powder of Example 1-10 refrigerates 6 months under the conditions of 4 DEG C, observation indicate that:Appearance is as before, no discoloration,
Situations such as caking, aging, occurs, and illustrates that ageing stability is good.
4, anti-freezing stability
The soluble powder of embodiment 1-10 is preserved after a week for -10 DEG C in refrigerator, restores to room temperature to observe.The result shows that:It is real
Situations such as soluble powder appearance for applying a 1-10 is as before, no discoloration, caking, aging occurs, and shows that freezing-resistance is good.
Soluble test
Since Amoxicillin drug itself is slightly soluble in water, need to judge its dissolubility after being prepared into soluble powder, to examine
Examine the technique effect of the present invention.
By taking 30% amoxicillin soluble powder prepared by embodiment 1 as an example, take 10.0g samples respectively with 1: 50,1: 100,1:
200 and 1: 500 mass ratio(Amoxicillin soluble powder: water)It is dissolved in tap water.Take the Amoxicillins 3.0g original powder simultaneously
As a contrast, to judge the water solubility of drug.
As a result such as following table:
The result shows that:Amoxicillin soluble powder obtained by 1 prescription of embodiment and technique is greatly improved the solubility of drug, highest
Concentration can be completely dissolved with 1: 50 amount.
Solubility experiment is carried out to 2 ~ 10 product of embodiment and 2 product of reference examples according to same experimental program, is found
In 1: 100 ratio dissolving, system clear is completely dissolved 2 ~ 10 product of embodiment, but in 1: 50 ratio condition lower body
System is muddy, and insoluble matter is arranged at bottom;In 1: 200 ratio dissolving, system clear is completely dissolved 2 product of reference examples, but
1: 50 ~ 1: 100 ratio condition lower body systems are muddy, and insoluble matter is arranged at bottom.It is demonstrated experimentally that the prescription and technique of embodiment 1 are best.
Drug safety is tested
Following safety testing is carried out by sample of amoxicillin soluble powder made from embodiment 1.
Medicine safety testing:The blue brown chick in 100 30 ages in days health sea are randomly divided into 5 groups, every group 20,5 groups of difference
Labeled as blank control group, drug control group, experiment low dose group, experiment middle dose group and experiment high dose group.Wherein compare
Group gavages tap water;The Amoxicillin original powder of middle dose group same amount is drunk and tested to drug control group;Test low dose group, middle dose
Normal amount is administered in amount group and high dose group respectively(It is primary by weight in terms of Amoxicillin:15mg/kg), 5 times of amounts(With A Moxi
Woods meter, it is primary by weight:75mg/kg)It is measured with 10 times(It is primary by weight in terms of Amoxicillin:150mg/kg)Drug, one day
Once, 7d is used in conjunction.The Behavioral change and death condition that each group chicken is observed during attacking poison, chicken is put to death, observe it after experiment
The lesion situation of internal organs, and record.
It is that sample carries out safety examination to amoxicillin soluble powder made from other embodiment using this test method
It tests.
As a result show:Each group chicken group's activity condition and health status are normal, each internal organs also lesion without exception after dissect,
Indifference between each group, this shows the amoxicillin soluble powder good security of the present invention.
The test of pesticide effectiveness
The following test of pesticide effectiveness is carried out by sample of amoxicillin soluble powder made from embodiment 1.
25 age in days white meat-type chickens of 60 ehec infections are randomly divided into 2 groups, every group 30, each group chicken state of an illness is basic
Identical, clinical symptoms and pathological change difference is not notable, and two groups of chickens are respectively labeled as test group and control group.Test group is free
The tap water added with 1 amoxicillin soluble powder drug of embodiment is drunk, dosage is that 100g drugs are dissolved in 250L water, control group
Free drinking public water supply, other rearing conditions are identical, continuous use 3d, observe the recovery situation of disease later, record and count
Analysis.
Judging quota:It is dead --- refer to experiment periods intercurrent disease chicken and death occurs;
The death rate=(The dead total experimental chicken numbers of chicken number ÷)×100%;
In vain --- after referring to experiment, diseased chicken is not dead, but clinical symptoms are also not apparent from improvement or more serious;
Inefficiency=(The clinical invalid total experimental chicken numbers of chicken number ÷)×100%;
Lapse to --- during referring to experiment, diseased chicken is not dead but the symptoms were significantly improved, is in vesting period;
Lapse to rate=(The total experimental chicken numbers of chicken number ÷ lapsed to)×100%;
Cure --- after referring to experiment, diseased chicken disease fully recovers;
Cure rate=(The total experimental chicken numbers of chicken number ÷ of healing)×100%;
It is efficient=to lapse to rate+cure rate.
Test result:The test group death rate 10%, inefficiency 10%, the rate that lapses to are 33.3%, cure rate 46.6%;Control group is dead
Rate 33.3% is died, inefficiency 60% lapses to rate 6.7%, and it is 0 to cure number.Bulk testing group effective percentage has reached 80%, and control group does not have to
Medicine, efficient in the case of being resisted by chicken autoimmunity is only 6.7%.
The result shows that:The amoxicillin soluble powder of the present invention has preferable treatment to chicken pathogenic escherichia coli infection
Effect.
Claims (4)
1. a kind of amoxicillin soluble powder, which is characterized in that by the sum of parts by weight be 100 parts in terms of, parts by weight group becomes:
0.01 ~ 50 part of Amoxicillin original powder, 1 ~ 20 part of PVP K30,0.01 ~ 0.5 part of sodium sulfite, 0.01 ~ 1.0 part of EDTA, it is remaining
Amount is mannitol.
2. amoxicillin soluble powder as described in claim 1, which is characterized in that by the sum of parts by weight be 100 parts in terms of,
Parts by weight group becomes:10 ~ 40 parts of Amoxicillin original powder, 5 ~ 15 parts of PVP K30,0.2 ~ 0.4 part of sodium sulfite, EDTA 0.2 ~
0.6 part, surplus is mannitol.
3. amoxicillin soluble powder as described in claim 1, which is characterized in that by the sum of parts by weight be 100 parts in terms of,
Parts by weight group becomes:30 parts of Amoxicillin original powder, 10 parts of PVP K30,0.3 part of sodium sulfite, 0.4 part of EDTA, surplus are
Mannitol.
4. a kind of preparation method of amoxicillin soluble powder as described in claim 1 ~ 3 is any, which is characterized in that including with
Lower step:
(a), at room temperature, PVP K30 is dissolved in the in the mixed solvent of absolute ethyl alcohol and petroleum ether composition, mixing obtains system
1;The additive amount of the absolute ethyl alcohol and petroleum ether is respectively 2 ~ 3 times of PVP K30 quality;
(b), in system 1 be added Amoxicillin original powder, stir evenly, obtain system 2;
(c), system 2 is spray-dried between 10 ~ 50 DEG C;
(d), by step(c)Resulting material is with sodium sulfite, EDTA and mannitol mixing to get finished product amoxicillin soluble
Powder.
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Cited By (3)
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CN110613750A (en) * | 2019-09-30 | 2019-12-27 | 河南牧翔动物药业有限公司 | Preparation method of soluble cinnamomum longepaniculatum essential oil powder |
CN113304112A (en) * | 2021-05-26 | 2021-08-27 | 浙江耐司康药业有限公司 | Amoxicillin soluble powder and preparation method thereof |
CN117379378A (en) * | 2023-12-07 | 2024-01-12 | 山东金瑞生物科技有限公司 | Compound amoxicillin soluble powder for livestock and preparation process thereof |
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CN113304112A (en) * | 2021-05-26 | 2021-08-27 | 浙江耐司康药业有限公司 | Amoxicillin soluble powder and preparation method thereof |
CN117379378A (en) * | 2023-12-07 | 2024-01-12 | 山东金瑞生物科技有限公司 | Compound amoxicillin soluble powder for livestock and preparation process thereof |
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