CN106491538B - carbasalate calcium soluble powder and preparation method thereof - Google Patents
carbasalate calcium soluble powder and preparation method thereof Download PDFInfo
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- CN106491538B CN106491538B CN201611102238.0A CN201611102238A CN106491538B CN 106491538 B CN106491538 B CN 106491538B CN 201611102238 A CN201611102238 A CN 201611102238A CN 106491538 B CN106491538 B CN 106491538B
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- carbasalate calcium
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- carbasalate
- soluble powder
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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
- A61K31/60—Salicylic acid; Derivatives thereof
- A61K31/612—Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid
- A61K31/616—Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid by carboxylic acids, e.g. acetylsalicylic acid
-
- 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
- A61K9/145—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
-
- 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
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
Abstract
The present invention provides a kind of carbasalate calcium soluble powders, it includes the component of following mass percent: carbasalate calcium 45%~55%, hydrolysis retarding agent 0.5%~2%, pH adjusting agent 0.05~0.1%, film forming agent 5%~10% and water-solubility carrier 32.9%~49.45%.The present invention also provides a kind of preparation methods of above-mentioned bar woods calcium soluble powder.Carbasalate calcium soluble powder provided by the invention is with good stability under the conditions of different pH value and temperature, and facile hydrolysis does not generate salicylic acid, avoids irritant to mucous membrane of animal, and safer, side effect is low.
Description
Technical field
The present invention relates to animal pharmaceuticals formulation arts, and in particular, to a kind of carbasalate calcium soluble powder and its preparation
Method.
Background technique
Carbasalate calcium (Carbasalate calcium) is also known as calcium salicylate salicylate, be a kind of calcium acetylsalicylate with
The complex salt of urea, white amorphous powder, easy moisture absorption agglomeration, soluble easily in water, pH value of water solution 4.8.It is the current country
The oral analgesic-antipyretic for livestock and poultry for uniquely obtaining Ministry of Agriculture's approval, belongs to national three classes novel chiral synthon.
Carbasalate calcium can absorb rapidly after animal is oral, and degradation in vivo is salicylic acid, inhibit cyclo-oxygenase and peanut
Tetraenoic acid synthesis of prostaglandins, to play antipyretic-antalgic and anti-inflammatory effect.The Oral drug absorption is rapid, complete, in stomach
Absorption is had begun, absorbable most of in upper part of small intestine, blood drug concentration peak time is 15 min~20 after taking orally
min.Carbaspirin is distributed in each tissue after absorbing, and the salicylate protein binding rate after hydrolysis is 65%~90%, relatively raw
Object availability is 111.8%.
But Carbaspirin calcium stability is poor, facile hydrolysis, hydrolysis be first order reaction, by temperature and pH value influenced compared with
Greatly, temperature is higher under same pH value, and the hydrolysis rate of carbasalate calcium is faster, and is also easy to inhale during storage and feeding
Tide, generates salicylic acid at hydrolysis, stimulates animal mucous membrane.
Summary of the invention
In view of this, the present invention provides a kind of carbasalate calcium soluble powder and preparation method thereof, to solve the above problems.
Specifically, the present invention adopts the following technical scheme that:
A kind of carbasalate calcium soluble powder, it includes the component of following mass percent: carbasalate calcium 45%~55%,
Hydrolyze retarding agent 0.5%~2%, pH adjusting agent 0.05~0.1%, film forming agent 5%~10% and water-solubility carrier 32.9%~49.45%.
Based on above-mentioned, the hydrolysis retarding agent is or mixtures thereof one of citric acid, tartaric acid.Wherein, the water
Retarding agent is solved as a kind of acid stabilizer, the hydrolysis of carbasalate calcium can be blocked, reduce salicylic generation.
Based on above-mentioned, the pH adjusting agent is or mixtures thereof one of sodium dihydrogen phosphate, disodium hydrogen phosphate.Wherein,
The pH adjusting agent can reduce the hydrolysis rate of carbasalate calcium soluble powder, water when it being avoided to enter animal oral cavity and throat
Poplar acid content is excessively high, generates stimulation to animal oral cavity and mucosa.
Based on above-mentioned, the film forming agent is one of copolyvidone PVP/VA64, copolyvidone PVPS-630 or it is mixed
Close object.Wherein, the copolyvidone PVP/VA64 is by n-vinyl-2-pyrrolidone and vinylacetate about with 60:40
The water solubility copolymer of ratio synthesis；The copolyvidone PVPS-630 polyvinylpyrrolidone vinylacetate copolymers, two
Person is to be soluble in alcohol and water, is not easy the moisture absorption, and carbasalate calcium is wrapped up, and avoids its dampness hydrolysis.
Based on above-mentioned, the water-solubility carrier is one of water soluble starch, lactose, DEXTROSE ANHYDROUS or it is arbitrary
Mixture.
A kind of preparation method of above-mentioned carbasalate calcium soluble powder comprising following steps:
Film forming agent is dissolved in medicinal alcohol solution, preparing and obtaining mass fraction is 5%~10% into film liquid；
Under the conditions of 30 DEG C~40 DEG C of temperature, carbasalate calcium, hydrolysis retarding agent, pH adjusting agent are put into layering pelletization
It is granulated in machine, and sprays into described at film liquid, form the carbasalate calcium of microencapsulation；
Water-solubility carrier and the carbasalate calcium of the microencapsulation are uniformly mixed, it is soluble to obtain the carbasalate calcium
Powder.
Based on above-mentioned, the fineness of the carbasalate calcium, the hydrolysis retarding agent and the pH adjusting agent is 100 mesh.
Compared with prior art, the hydrolysis retarding agent is added in the carbasalate calcium soluble powder provided by the invention
With the pH adjusting agent, make the carbasalate calcium soluble powder that there is good stabilization under the conditions of different pH value and temperature
Property, facile hydrolysis generates salicylic acid, avoids irritant to mucous membrane of animal, and safer, side effect is low, and using described total
The povidone PVP/VA64 or/and copolyvidone PVPS-630, can be to avoid in storage, transport and feeding as film forming agent
Easily occurs moisture absorption problem in journey；In addition, the preparation method of the carbasalate calcium soluble powder provided by the invention is simple, it is convenient
Industrial application.
Specific embodiment
Below by specific embodiment, technical scheme of the present invention will be described in further detail.
Embodiment 1
The present embodiment carbasalate calcium soluble powder, including following components (pressing 1000g meter):
| Carbasalate calcium | 500 g |
| Lactose | 390 g |
| Tartaric acid | 5 g |
| Sodium dihydrogen phosphate | 5 g |
| Copolyvidone PVPS-630 | 100 g |
Specific preparation step are as follows:
(1) carbasalate calcium, tartaric acid and sodium dihydrogen phosphate are sieved with 100 mesh sieve respectively spare；
(2) carbasalate calcium, lactose, tartaric acid, sodium dihydrogen phosphate and copolyvidone are weighed according to the weight of the present embodiment
PVPS-630 is spare；
(3) step (2) is weighed copolyvidone PVPS-630 to be dissolved in medicinal alcohol solution, preparation obtains mass fraction
For 10% it is spare at film liquid；
(3) weighed carbasalate calcium, tartaric acid and sodium dihydrogen phosphate in step (2) are poured into layering pelletization machine, is adopted
Film liquid is sprayed into the mode that bottom is sprayed, forms the carbasalate calcium of microencapsulation under the conditions of 30 DEG C of temperature；
(4) weighed lactose and the carbasalate calcium of microencapsulation in step (2) are added in three-dimensional mixer mix together
Uniformly, the carbasalate calcium soluble powder is obtained.
Embodiment 2
The present embodiment carbasalate calcium soluble powder, including following components (pressing 1000g meter):
| Carbasalate calcium | 500 g |
| Soluble starch | 410 g |
| Citric acid | 5 g |
| Sodium dihydrogen phosphate | 5 g |
| Copolyvidone PVP/VA 64 | 80 g |
Specific preparation step are as follows:
(1) carbasalate calcium, citric acid and sodium dihydrogen phosphate are sieved with 100 mesh sieve respectively spare；
(2) carbasalate calcium, soluble starch, citric acid, sodium dihydrogen phosphate are weighed according to the weight of the present embodiment and be total to
Povidone PVP/VA 64 is spare；
(3) step (2) is weighed copolyvidone PVP/VA 64 to be dissolved in medicinal alcohol solution, preparation obtains quality point
Number for 5% it is spare at film liquid；
(3) the weighed carbasalate calcium of step (2), citric acid and sodium dihydrogen phosphate are poured into layering pelletization machine, is used
The mode of bottom spray sprays into film liquid, and the carbasalate calcium of microencapsulation is formed under the conditions of 40 DEG C of temperature；
(4) three-dimensional mixer is added in weighed soluble starch and the carbasalate calcium of microencapsulation in step (2) together
In be uniformly mixed, obtain the carbasalate calcium soluble powder.
Embodiment 3
The present embodiment carbasalate calcium soluble powder, including following components (pressing 1000g meter):
| Carbasalate calcium | 500 g |
| Soluble starch | 410 g |
| Citric acid | 3 g |
| Tartaric acid | 2 g |
| Disodium hydrogen phosphate | 5 g |
| Copolyvidone PVP/VA 64 | 80 g |
Specific preparation step are as follows:
(1) carbasalate calcium, citric acid, tartaric acid and disodium hydrogen phosphate are sieved with 100 mesh sieve respectively spare；
(2) carbasalate calcium, soluble starch, citric acid, tartaric acid, phosphoric acid hydrogen two are weighed according to the weight of the present embodiment
Sodium and copolyvidone PVP/VA 64 are spare；
(3) step (2) is weighed copolyvidone PVP/VA 64 to be dissolved in medicinal alcohol solution, preparation obtains quality point
Number for 5% it is spare at film liquid；
(3) weighed carbasalate calcium, citric acid, tartaric acid and disodium hydrogen phosphate in step (2) are poured into layering pelletization
In machine, film liquid is sprayed by the way of the spray of bottom, forms the carbasalate calcium of microencapsulation under the conditions of 40 DEG C of temperature；
(4) carbasalate calcium of soluble starch and microencapsulation in step (2) is added together in three-dimensional mixer and is mixed
It closes uniformly, obtains the carbasalate calcium soluble powder.
Embodiment 4
The present embodiment carbasalate calcium soluble powder, including following components (pressing 1000g meter):
| Carbasalate calcium | 500 g |
| DEXTROSE ANHYDROUS | 410 g |
| Citric acid | 3 g |
| Tartaric acid | 2 g |
| Disodium hydrogen phosphate | 5 g |
| Copolyvidone PVPS-630 | 40 g |
| Copolyvidone PVP/VA 64 | 40 g |
Specific preparation step are as follows:
(1) carbasalate calcium, citric acid, tartaric acid and disodium hydrogen phosphate are sieved with 100 mesh sieve respectively spare；
(2) carbasalate calcium, DEXTROSE ANHYDROUS, citric acid, tartaric acid, phosphoric acid hydrogen two are weighed according to the weight of the present embodiment
Sodium, copolyvidone PVPS-630 and copolyvidone PVP/VA 64 are spare；
(3) step (1) is weighed into copolyvidone PVP/VA 64 and copolyvidone PVPS-630 is dissolved in medicinal alcohol solution
In, prepare obtain mass fraction be 5% it is spare at film liquid；
(3) weighed carbasalate calcium, citric acid, tartaric acid and disodium hydrogen phosphate in step (2) are poured into layering pelletization
In machine, film liquid is sprayed by the way of the spray of bottom, forms the carbasalate calcium of microencapsulation under the conditions of 38 DEG C of temperature；
(4) three-dimensional mixer is added in weighed DEXTROSE ANHYDROUS and the carbasalate calcium of microencapsulation in step (2) together
In be uniformly mixed, obtain the carbasalate calcium soluble powder.
The stability test of carbasalate calcium soluble powder
The stability of following experiments group and blank group is tested:
Experimental group 1~4: carbasalate calcium soluble powder made from corresponding embodiment 1~4.
Blank group: carbasalate calcium 500g and lactose 500g is uniformly mixed.
Experimental method:
1, experimental group, blank group are saved in 60 DEG C, and the salicylic acid content after measuring and calculating 0 day, 5 days, 10 days, experimental result is shown in Table
1。
2, experimental group, blank group are being stored at room temperature, and calculate 0 day, 30 days, 60 days, 90 days salicylic acid contents, experimental result is shown in
Table 2.
Salicylic acid content changes over time in carbasalate calcium soluble powder at 1 60 DEG C of table
Salicylic acid content changes over time in carbasalate calcium soluble powder under 2 room temperature of table
The result shows that: compared with carbasalate calcium soluble powder in blank group, carbasalate calcium prepared by the present invention is solvable
Property powder at normal temperature with temperature be 60 DEG C when storage a period of time after hydrolyze generation salicylic acid it is less, storage stability is preferable,
It has broad application prospects.
Embodiment 5
The present embodiment carbasalate calcium soluble powder, including following components (pressing 1000g meter):
| Carbasalate calcium | 550 g |
| DEXTROSE ANHYDROUS | 330 g |
| Citric acid | 6 g |
| Tartaric acid | 4 g |
| Disodium hydrogen phosphate | 10 g |
| Copolyvidone PVPS-630 | 50 g |
| Copolyvidone PVP/VA 64 | 50 g |
Specific preparation step are as follows:
(1) carbasalate calcium, citric acid, tartaric acid and disodium hydrogen phosphate are sieved with 100 mesh sieve respectively spare；
(2) carbasalate calcium, DEXTROSE ANHYDROUS, citric acid, tartaric acid, phosphoric acid hydrogen two are weighed according to the weight of the present embodiment
Sodium, copolyvidone PVPS-630 and copolyvidone PVP/VA 64 are spare；
(3) step (1) is weighed into copolyvidone PVP/VA 64 and copolyvidone PVPS-630 is dissolved in medicinal alcohol solution
In, prepare obtain mass fraction be 5% it is spare at film liquid；
(3) weighed carbasalate calcium, citric acid, tartaric acid and disodium hydrogen phosphate in step (2) are poured into layering pelletization
In machine, film liquid is sprayed by the way of the spray of bottom, forms the carbasalate calcium of microencapsulation under the conditions of 38 DEG C of temperature；
(4) three-dimensional mixer is added in weighed DEXTROSE ANHYDROUS and the carbasalate calcium of microencapsulation in step (2) together
In be uniformly mixed, obtain the carbasalate calcium soluble powder.
Carbasalate calcium soluble powder made from the present embodiment carries out stability test, saves 90 days under room temperature, bigcatkin willow
Acid content is 0.37%, is saved 10 days at 60 DEG C, salicylic acid content 0.39%, has good storage stability.
Embodiment 6
The present embodiment carbasalate calcium soluble powder, including following components (pressing 1000g meter):
| Carbasalate calcium | 450 g |
| DEXTROSE ANHYDROUS | 420 g |
| Citric acid | 10 g |
| Tartaric acid | 10 g |
| Disodium hydrogen phosphate | 10 g |
| Copolyvidone PVPS-630 | 50 g |
| Copolyvidone PVP/VA 64 | 50 g |
Specific preparation step are as follows:
(1) carbasalate calcium, citric acid, tartaric acid and disodium hydrogen phosphate are sieved with 100 mesh sieve respectively spare；
(2) carbasalate calcium, DEXTROSE ANHYDROUS, citric acid, tartaric acid, phosphoric acid hydrogen two are weighed according to the weight of the present embodiment
Sodium, copolyvidone PVPS-630 and copolyvidone PVP/VA 64 are spare；
(3) step (1) is weighed into copolyvidone PVP/VA 64 and copolyvidone PVPS-630 is dissolved in medicinal alcohol solution
In, prepare obtain mass fraction be 5% it is spare at film liquid；
(3) weighed carbasalate calcium, citric acid, tartaric acid and disodium hydrogen phosphate in step (2) are poured into layering pelletization
In machine, film liquid is sprayed by the way of the spray of bottom, forms the carbasalate calcium of microencapsulation under the conditions of 38 DEG C of temperature；
(4) three-dimensional mixer is added in weighed DEXTROSE ANHYDROUS and the carbasalate calcium of microencapsulation in step (2) together
In be uniformly mixed, obtain the carbasalate calcium soluble powder.
Carbasalate calcium soluble powder made from the present embodiment carries out stability test, saves 90 days under room temperature, bigcatkin willow
Acid content is 0.36%, is saved 10 days at 60 DEG C, salicylic acid content 0.37%, has good storage stability.
Finally it should be noted that: the above embodiments are merely illustrative of the technical scheme of the present invention and are not intended to be limiting thereof；To the greatest extent
The present invention is described in detail with reference to preferred embodiments for pipe, it should be understood by those ordinary skilled in the art that: still
It can modify to a specific embodiment of the invention or some technical features can be equivalently replaced；Without departing from this hair
The spirit of bright technical solution should all cover within the scope of the technical scheme claimed by the invention.
Claims (2)
1. a kind of carbasalate calcium soluble powder, which is characterized in that it includes the component of following mass percent: carbasalate calcium
45%~55%, retarding agent 0.5%~2%, pH adjusting agent 0.05%~0.1%, film forming agent 5%~10% and water-solubility carrier are hydrolyzed
32.9%~49.45%；Wherein, the hydrolysis retarding agent is or mixtures thereof one of citric acid, tartaric acid, and the pH is adjusted
Agent is or mixtures thereof one of sodium dihydrogen phosphate, disodium hydrogen phosphate, and the film forming agent is copolyvidone PVP/VA64, is copolymerized
Or mixtures thereof one of ketone PVPS-630 is tieed up, the water-solubility carrier is water soluble starch, in lactose, DEXTROSE ANHYDROUS
One kind or its arbitrary mixture；
The preparation method of the carbasalate calcium soluble powder comprising following steps:
The film forming agent is dissolved in medicinal alcohol solution, preparing and obtaining mass fraction is 5%~10% into film liquid；
Under the conditions of 30 DEG C~40 DEG C of temperature, carbasalate calcium, the hydrolysis retarding agent, the pH adjusting agent are put into coating
It is granulated in granulator, and sprays into described at film liquid, form the carbasalate calcium of microencapsulation；
The water-solubility carrier and the carbasalate calcium of the microencapsulation are uniformly mixed, it is soluble to obtain the carbasalate calcium
Powder.
2. carbasalate calcium soluble powder according to claim 1, which is characterized in that the carbasalate calcium, the water
The fineness for solving retarding agent and the pH adjusting agent is 100 mesh.
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| CN107616970B (en) * | 2017-10-19 | 2020-10-23 | 洛阳瑞华动物保健品有限公司 | Carbazoline calcium soluble powder and preparation method thereof |
| CN111557915A (en) * | 2020-06-17 | 2020-08-21 | 江西派尼生物药业有限公司 | Veterinary high-water-solubility carbapenem calcium soluble powder |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101152184A (en) * | 2007-09-06 | 2008-04-02 | 浙江大学 | Diclazuril effervescence patch for birds |
| CN101606908A (en) * | 2009-07-10 | 2009-12-23 | 华南农业大学实验兽药厂 | Decoquinate soluble powder and preparation method thereof |
| CN105287477A (en) * | 2015-09-16 | 2016-02-03 | 四川伴农动保生物技术有限公司 | Carbasalate calcium powder and preparation method thereof |
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2016
- 2016-12-05 CN CN201611102238.0A patent/CN106491538B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101152184A (en) * | 2007-09-06 | 2008-04-02 | 浙江大学 | Diclazuril effervescence patch for birds |
| CN101606908A (en) * | 2009-07-10 | 2009-12-23 | 华南农业大学实验兽药厂 | Decoquinate soluble powder and preparation method thereof |
| CN105287477A (en) * | 2015-09-16 | 2016-02-03 | 四川伴农动保生物技术有限公司 | Carbasalate calcium powder and preparation method thereof |
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