CN108992402A - albendazole suspension and preparation method thereof - Google Patents
albendazole suspension and preparation method thereof Download PDFInfo
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- CN108992402A CN108992402A CN201811134151.0A CN201811134151A CN108992402A CN 108992402 A CN108992402 A CN 108992402A CN 201811134151 A CN201811134151 A CN 201811134151A CN 108992402 A CN108992402 A CN 108992402A
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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
- A61K9/10—Dispersions; Emulsions
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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
- A61K31/4164—1,3-Diazoles
- A61K31/4184—1,3-Diazoles condensed with carbocyclic rings, e.g. benzimidazoles
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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
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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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
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
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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
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P33/00—Antiparasitic agents
- A61P33/10—Anthelmintics
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Abstract
The present invention relates to the technical fields of veterinary drug, disclose albendazole suspension and preparation method thereof, every 100ml suspension includes the following components by percent by volume metering: albendazole 10%~20%, emulsifier 12%~16%, thickener 0.013%~0.015%, stabilizer 1%~1.5%, suspending agent 5.5%~6%, preservative 0.25%~0.3%, acidity regulator, surplus is filled with water；Albendazole suspension provided by the invention and preparation method thereof, which has the advantage that (1), can solve existing Albenza feeds difficulty to livestock, cumbersome, easily causes the bad phenomenon of vomiting；(2), emulsifying effectiveness is good, and it is not in lamination that suspension, which was placed in a week, and albendazole is evenly distributed in suspension, can effectively prevent influencing anthelminthic effect due to the uneven caused poisoning of suspension or dosage inaccuracy；(3), applied widely, it can be watered with arbitrary proportion, suspension effect is good, can be suspended for a long time, can prevent the drug poisoning due to caused by drug precipitation.
Description
Technical field
The present invention relates to the technical fields of veterinary drug, especially Albendazole suspension and preparation method thereof.
Background technique
Albendazole (Albendazole) also known as albendazole belong to benzimidazole, the entitled 5- rosickyite base -1H- benzene of chemistry
And imidazoles -2- methyl carbamate, be a kind of wide spectrum, efficiently, the anthelmintic drug for animals of low toxicity.It is to nematode, blood fluke, tapeworm
There is high activity, and has to ovulation development and significantly inhibit effect.To parasitize the various nematodes of animal body, blood fluke,
Tapeworm and cysticercus also have apparent expeling effect.
It is both not soluble in water or be also insoluble in most of organic solvent since albendazole belongs to indissoluble substance, it is dissolved only in certain
In a little acid, it is extremely restricted its application.There was only tablet using wide albendazole preparation at present, in making for animal husbandry
In, to livestock using when due to throw take it is cumbersome, easily cause livestock vomiting to cause taking dose inaccuracy and shadow
Ring anthelminthic effect.
Summary of the invention
To make up the deficiencies in the prior art, the purpose of the present invention is to provide a kind of stability height, preparation process are simple, honest and clean
Valence, efficient, the convenient Albendazole suspension of dispensing and preparation method thereof.
The invention is realized in this way albendazole suspension, which is characterized in that every 100ml Albendazole suspension
Include the following components by percent by volume metering:
Acidity regulator,
Surplus is filled with water.
Further, the emulsifier includes sorbester p18 and polysorbate85.
Further, the thickener is hydroxypropyl methyl cellulose.
Further, the stabilizer is sodium citrate.
Further, the suspending agent is Liquid Macrogol.
Further, preservative used is potassium sorbate.
Further, acidity regulator used is glacial acetic acid.
Further, following component is contained in every 100ml Albendazole suspension:
Further, comprising the following steps:
(1), the sorbester p18 for weighing recipe quantity adds water and stirs and is heated to about 60 DEG C of sufficiently dissolutions；
(2), the polysorbate85 for weighing recipe quantity is added in the solution of step (1), is quickly stirred with blender, is made to emulsify
Agent is fully emulsified；
(3), by recipe quantity sodium citrate and potassium sorbate weigh up, dissolved with water, then be added step (2) emulsification
In liquid, it is sufficiently stirred；
(4), the hydroxypropyl methyl cellulose of recipe quantity is weighed, is added in the emulsion of step (3), is sufficiently stirred；
(5), the Liquid Macrogol of recipe quantity is weighed, is added in the emulsion of step (4), is sufficiently stirred；
(6), the albendazole of recipe quantity is weighed, is added in the emulsion of step (5), is sufficiently stirred；
(7), water is added into the mixture of step (6), it is stirring while adding, with water constant volume；
(8), PH is adjusted 5.0~7.0 to get veterinary albendazole suspension with the glacial acetic acid in prescription.
Compared with prior art, Albendazole suspension provided by the invention and preparation method thereof has the advantage that
(1), existing Albenza can be solved and difficulty is fed to livestock, it is cumbersome, easily cause the bad existing of vomiting
As；
(2), the emulsifying effectiveness spy of Albendazole suspension provided by the invention is good, and suspension is placed will not go out in a week
Existing lamination, albendazole are evenly distributed in suspension, can effectively prevent due to suspension it is uneven caused by poisoning or
Dosage is inaccurate and influences anthelminthic effect；
(3), the present invention is applied widely, can be watered with arbitrary proportion, suspension effect is good, can be suspended for a long time, can prevent
The drug poisoning due to caused by drug precipitation.
Specific embodiment
In order to make the objectives, technical solutions, and advantages of the present invention clearer, with reference to embodiments, to the present invention
It is further elaborated.It should be appreciated that the specific embodiments described herein are merely illustrative of the present invention, it is not used to
Limit the present invention.
Realization of the invention is described in detail below in conjunction with specific embodiment.
Albendazole suspension, every 100ml Albendazole suspension include the following components by percent by volume metering:
Acidity regulator,
Surplus is filled with water.
Further, the emulsifier includes sorbester p18 and polysorbate85.
Further, the thickener is hydroxypropyl methyl cellulose.
Further, the stabilizer is sodium citrate.
Further, the suspending agent is Liquid Macrogol.
Further, preservative used is potassium sorbate.
Further, acidity regulator used is glacial acetic acid.
Preferably, following component is contained in every 100ml Albendazole suspension:
The preparation method of above-mentioned Albendazole suspension, comprising the following steps:
(1), the sorbester p18 for weighing recipe quantity adds water and stirs and is heated to about 60 DEG C of sufficiently dissolutions；
(2), the polysorbate85 for weighing recipe quantity is added in the solution of step (1), is quickly stirred with blender, is made to emulsify
Agent is fully emulsified；
(3), by recipe quantity sodium citrate and potassium sorbate weigh up, dissolved with water, then be added step (2) emulsification
In liquid, it is sufficiently stirred；
(4), the hydroxypropyl methyl cellulose of recipe quantity is weighed, is added in the emulsion of step (3), is sufficiently stirred；
(5), the Liquid Macrogol of recipe quantity is weighed, is added in the emulsion of step (4), is sufficiently stirred；
(6), the albendazole of recipe quantity is weighed, is added in the emulsion of step (5), is sufficiently stirred；
(7), water is added into the mixture of step (6), it is stirring while adding, with water constant volume；
(8), PH is adjusted 5.0~7.0 to get veterinary albendazole suspension with the glacial acetic acid in prescription.
The Albendazole suspension and preparation method thereof of above-mentioned offer has the advantage that
(1), existing Albenza can be solved and difficulty is fed to livestock, it is cumbersome, easily cause the bad existing of vomiting
As；
(2), the emulsifying effectiveness spy of Albendazole suspension provided by the invention is good, and suspension is placed will not go out in a week
Existing lamination, albendazole are evenly distributed in suspension, can effectively prevent due to suspension it is uneven caused by poisoning or
Dosage is inaccurate and influences anthelminthic effect；
(3), the present invention is applied widely, can be watered with arbitrary proportion, suspension effect is good, can be suspended for a long time, can prevent
The drug poisoning due to caused by drug precipitation.
Embodiment 1
(1) 1kg sorbester p18 is weighed, adds water and stirs and is heated to about 60 DEG C of sufficiently dissolutions, pour into liquid dispensing container；
(2) polysorbate85 for weighing 11kg is added in the solution of step (1), is quickly stirred with blender, is filled emulsifier
Divide emulsification；
(3) 1kg sodium citrate and 250g potassium sorbate are weighed, is dissolved with water, is then added in the emulsion of step (2),
It is sufficiently stirred；
(4) 13g hydroxypropyl methyl cellulose is weighed, is added in the emulsion of step (3), is sufficiently stirred；
(5) 5.5kg Liquid Macrogol is weighed, is added in the emulsion of step (4), is sufficiently stirred；
(6) 10kg albendazole is weighed, is added in the emulsion of step (5), is sufficiently stirred；
(7) water is added into the mixture of step (6), it is stirring while adding, 100L is settled to water；
(8) PH is adjusted 5.0~7.0 to get veterinary albendazole suspension with the glacial acetic acid in prescription.
Embodiment 2
(1) 2kg sorbester p18 is weighed, adds water and stirs and is heated to about 60 DEG C of sufficiently dissolutions；
(2) polysorbate85 for weighing 14kg is added in the solution of step (1), is quickly stirred with blender, is filled emulsifier
Divide emulsification；
(3) 1kg sodium citrate and 250g potassium sorbate are weighed, is dissolved with water, is then added in the emulsion of step (2),
It is sufficiently stirred；
(4) 13g hydroxypropyl methyl cellulose is weighed, is added in the emulsion of step (3), is sufficiently stirred；
(5) 5.5kg Liquid Macrogol is weighed, is added in the emulsion of step (4), is sufficiently stirred；
(6) 10kg albendazole is weighed, is added in the emulsion of step (5), is sufficiently stirred；
(7) water is added into the mixture of step (6), it is stirring while adding, 100L is settled to water；
(8) PH is adjusted 5.0~7.0 to get veterinary albendazole suspension with the glacial acetic acid in prescription.
Embodiment 3
(1) 10kg sorbester p18 is weighed, adds water and stirs and is heated to about 60 DEG C of sufficiently dissolutions；
(2) polysorbate85 for weighing 8kg is added in the solution of step (1), is quickly stirred with blender, is filled emulsifier
Divide emulsification；
(3) 1kg sodium citrate and 250g potassium sorbate are weighed, is dissolved with water, is then added in the emulsion of step (2),
It is sufficiently stirred；
(4) 13g hydroxypropyl methyl cellulose is weighed, is added in the emulsion of step (3), is sufficiently stirred；
(5) 5.5kg Liquid Macrogol is weighed, is added in the emulsion of step (4), is sufficiently stirred；
(6) 10kg albendazole is weighed, is added in the emulsion of step (5), is sufficiently stirred；
(7) water is added into the mixture of step (6), it is stirring while adding, 100L is settled to water；
(8) PH is adjusted 5.0~7.0 to get veterinary albendazole suspension with the glacial acetic acid in prescription.
Embodiment 4
(1) 1kg sorbester p18 is weighed, adds water and stirs and is heated to about 60 DEG C of sufficiently dissolutions；
(2) polysorbate85 for weighing 11kg is added in the solution of step (1), is quickly stirred with blender, is filled emulsifier
Divide emulsification；
(3) 1kg sodium citrate and 250g potassium sorbate are weighed, is dissolved with water, is then added in the emulsion of step (2),
It is sufficiently stirred；
(4) 13g hydroxypropyl methyl cellulose is weighed, is added in the emulsion of step (3), is sufficiently stirred；
(5) 5.5kg Liquid Macrogol is weighed, is added in the emulsion of step (4), is sufficiently stirred；
(6) 15kg albendazole is weighed, is added in the emulsion of step (5), is sufficiently stirred；
(7) water is added into the mixture of step (6), it is stirring while adding, 100L is settled to water；
(8) PH is adjusted 5.0~7.0 to get veterinary albendazole suspension with the glacial acetic acid in prescription.
Embodiment 5
(1) 1kg sorbester p18 is weighed, adds water and stirs and is heated to about 60 DEG C of sufficiently dissolutions；
(2) polysorbate85 for weighing 11kg is added in the solution of step (1), is quickly stirred with blender, is filled emulsifier
Divide emulsification；
(3) 1kg sodium citrate and 250g potassium sorbate are weighed, is dissolved with water, is then added in the emulsion of step (2),
It is sufficiently stirred；
(4) 13g hydroxypropyl methyl cellulose is weighed, is added in the emulsion of step (3), is sufficiently stirred；
(5) 5.5kg Liquid Macrogol is weighed, is added in the emulsion of step (4), is sufficiently stirred；
(6) 20kg albendazole is weighed, is added in the emulsion of step (5), is sufficiently stirred；
(7) water is added into the mixture of step (6), it is stirring while adding, 100L is settled to water；
(8) PH is adjusted 5.0~7.0 to get veterinary albendazole suspension with the glacial acetic acid in prescription.
To the Albendazole suspension of 3 batches prepared by embodiment 1, carry out including character, identification, settling ratio, drug
The control detection of the quality such as content.
Character: the Albendazole suspension of 3 lot numbers is the suspension solution of fine particle, and fine particle is heavy after standing
It forms sediment, is in uniform off-white color suspension after shaking.
Identify: by " veterinary medical quality standard --- version chemicals volume in 2017 " to the Albendazole suspension of three batches
Identified, as a result meets regulation.
Sedimentation volume ratio: according to Chinese veterinary pharmacopoeia prescriptive procedure, the Albendazole suspension of 3 batches is taken to carry out settling ratio
Detection, settling ratio are all larger than 0.91.
Medicine assay: the acetysalicylic acid phenobarbital of three batches is reached by " veterinary medical quality standard --- version chemicals volume in 2017 "
Azoles suspension carries out assay.
Table 1, embodiment 1 first sample different location albendazole content
Table 2, embodiment 1 second batch sample different location albendazole content
Table 3, embodiment 1 third batch sample different location albendazole content
From testing result, three batches of samples of embodiment 1 content in the different location of receiver does not have notable difference,
Thus the uniformity of the provable sample is very good.
50 DEG C of three batches of samples placements 90 days of table 4, embodiment 1, detect its albendazole content
| Sample | Albendazole content % |
| First | 99.39 |
| Second batch | 99.54 |
| Third batch | 99.48 |
It from experimental data, is placed 90 days through high temperature, three batches of sample albendazole contents of embodiment 1 are without obvious
Variation, shows that the stability of the product is fine.
It is watered suspension test:
A group uses the suspension 10g of embodiment 1, adds water 100ml miscible, is statically placed in separatory funnel after shaking up.
B group uses the suspension 10g of embodiment 2, adds water 100ml miscible, is statically placed in separatory funnel after shaking up.
C group uses the suspension 10g of embodiment 3, adds water 100ml miscible, is statically placed in separatory funnel after shaking up.
D group uses the suspension 10g of embodiment 4, adds water 100ml miscible, is statically placed in separatory funnel after shaking up.
E group uses the suspension 10g of embodiment 5, adds water 100ml miscible, is statically placed in separatory funnel after shaking up.
Table 5, different time sections release solution from bottom, detect albendazole content
| Group | It places 0 minute | It places 15 minutes | It places 30 minutes | It places 60 minutes |
| A | 0.92% | 0.94% | 0.93% | 0.95% |
| B | 0.94% | 0.92% | 0.98% | 1.06% |
| C | 0.91% | 0.93% | 1.22% | 1.43% |
| D | 1.52% | 1.55% | 1.54% | 1.61% |
| E | 2.06% | 2.08% | 2.05% | 2.11% |
From result above as it can be seen that suspension effect is preferable after the sample is watered, places in 60 minutes and albendazole do not occur
Deposited phenomenon.
Feed test:
Albendazole tablet with the sample and specification of embodiment 1 for 0.1g feeds the pig of 10 weight about 50kg respectively, real
The feeding volume for applying example 1 is 5ml, feeding method are as follows: draws 5ml sample using syringe (removing syringe needle), directly throws into snoot；Ah
The feeding volume of parbendazole piece is 5g, and feeding method is directly to feed.
Pig takes situation after table 6, administration
| Sample | Occurs the pig (head) vomitted after feeding |
| 1 sample of embodiment | 0 |
| Albendazole tablet | 4 |
It feeds using this product from result above is visible and can generate vomiting phenomenon because of medication to avoid livestock, it is effective to improve
The utilization rate of albendazole, prevents to have fed and is equal to the case where not feeding.
The foregoing is merely illustrative of the preferred embodiments of the present invention, is not intended to limit the invention, all in essence of the invention
Made any modifications, equivalent replacements, and improvements etc., should all be included in the protection scope of the present invention within mind and principle.
Claims (9)
1. Albendazole suspension, which is characterized in that every 100ml Albendazole suspension include by percent by volume metering with
Lower component:
2. albendazole suspension as described in claim 1, which is characterized in that the emulsifier includes sorbester p18 and tween
85。
3. albendazole suspension as claimed in claim 2, which is characterized in that the thickener is hydroxypropyl methyl fiber
Element.
4. albendazole suspension as claimed in claim 3, which is characterized in that the stabilizer is sodium citrate.
5. albendazole suspension as claimed in claim 4, which is characterized in that the suspending agent is Liquid Macrogol.
6. albendazole suspension as claimed in claim 5, which is characterized in that preservative used is potassium sorbate.
7. albendazole suspension as claimed in claim 6, which is characterized in that acidity regulator used is glacial acetic acid.
8. albendazole suspension as claimed in claim 7, which is characterized in that contain in every 100ml Albendazole suspension
Following component:
9. the preparation method of Albendazole suspension as claimed in claim 8, which comprises the following steps:
(1), the sorbester p18 for weighing recipe quantity adds water and stirs and is heated to about 60 DEG C of sufficiently dissolutions；
(2), the polysorbate85 for weighing recipe quantity is added in the solution of step (1), is quickly stirred with blender, is filled emulsifier
Divide emulsification；
(3), by recipe quantity sodium citrate and potassium sorbate weigh up, dissolved with water, then be added step (2) emulsion
In, it is sufficiently stirred；
(4), the hydroxypropyl methyl cellulose of recipe quantity is weighed, is added in the emulsion of step (3), is sufficiently stirred；
(5), the Liquid Macrogol of recipe quantity is weighed, is added in the emulsion of step (4), is sufficiently stirred；
(6), the albendazole of recipe quantity is weighed, is added in the emulsion of step (5), is sufficiently stirred；
(7), water is added into the mixture of step (6), it is stirring while adding, with water constant volume；
(8), PH is adjusted 5.0~7.0 to get veterinary albendazole suspension with the glacial acetic acid in prescription.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN201811134151.0A CN108992402A (en) | 2018-09-27 | 2018-09-27 | albendazole suspension and preparation method thereof |
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| CN201811134151.0A CN108992402A (en) | 2018-09-27 | 2018-09-27 | albendazole suspension and preparation method thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110151692A (en) * | 2019-06-21 | 2019-08-23 | 石家庄九鼎动物药业有限公司 | A kind of antiparasite drugs for animals Albendazole suspension preparation method |
| CN113952308A (en) * | 2021-12-02 | 2022-01-21 | 山东国邦药业有限公司 | Albendazole granules and preparation method thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102440953A (en) * | 2011-12-29 | 2012-05-09 | 郑国祥 | Albendazole suspension preparation and preparation method thereof |
| CN105708850A (en) * | 2016-03-09 | 2016-06-29 | 华南农业大学 | Invermectin and fenbendazole suspension injection and preparing method thereof |
-
2018
- 2018-09-27 CN CN201811134151.0A patent/CN108992402A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102440953A (en) * | 2011-12-29 | 2012-05-09 | 郑国祥 | Albendazole suspension preparation and preparation method thereof |
| CN105708850A (en) * | 2016-03-09 | 2016-06-29 | 华南农业大学 | Invermectin and fenbendazole suspension injection and preparing method thereof |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110151692A (en) * | 2019-06-21 | 2019-08-23 | 石家庄九鼎动物药业有限公司 | A kind of antiparasite drugs for animals Albendazole suspension preparation method |
| CN113952308A (en) * | 2021-12-02 | 2022-01-21 | 山东国邦药业有限公司 | Albendazole granules and preparation method thereof |
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Application publication date: 20181214 |