CN106727304B - A kind of Fenbendazole suspension and preparation method thereof - Google Patents
A kind of Fenbendazole suspension and preparation method thereof Download PDFInfo
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Abstract
The present invention provides a kind of Fenbendazole suspensions, it mainly include Fenbendazole 8-12g, glycerol 10-25ml in every 100ml suspension, methylcellulose 0.1-0.7g, xanthan gum 0.1-1.5g, dextran-40 0-3g, Tween-80 0.1-1.5g, Arlacel-80 0.6-1.5g, sodium benzoate 0.1-0.3g, citric acid 1-3g, water supply surplus.Preparation method includes: to form mixed liquor after Fenbendazole to be mixed to wetting with glycerol, Tween-80, Arlacel-80；By sodium benzoate, citric acid, dextran-40 using after part aqueous solution, after addition methylcellulose, xanthan gum mix after mixing with the mixed liquor, it is uniformly mixed after adding remaining water.
Description
Technical field
The present invention relates to Fenbendazole suspension production field, in particular to a kind of Fenbendazole suspension and its
Preparation method.
Background technique
Fenbendazole is a kind of benzimidazole anti-parasite medicine, not only has height to gastrointestinal nematode parasites adult and larva
Anthelmintic activity is spent, and has good result to net tail nematode, fasciola and tapeworm, there are also extremely strong killing eggs to act on, fragrant benzene
It is white or off-white powder up to azoles, it is odorless, it is tasteless, it is not soluble in water, but glacial acetic acid and dimethyl sulfoxide are dissolved in, have slight
Hygroscopicity, property is stable and heat-resisting under drying regime, and when pH is 2-6, property is also stable.
Fenbendazole at home and abroad has been obtained and is widely applied, and Fenbendazole drug and the tubulin of polypide are mutually tied
It closes, prevents the polymerization of micro-pipe, so as to cause the micro-duct injury of the epidermis of larva or adult and enterocyte matter, reduce disappearing for polypide
The nutrient absorption rate of change, Fenbendazole can effectively prevent ox, fowl animal gastrointestinal tract nematode adult and larva such as trichostrongyle etc.
Caused disease, while the medicine also has certain curative effect to the infection of the helminths such as tapeworm, ascaris suum, through being widely applied
The prevention and treatment of the gastrointestinal parasite of many animals such as Yu Yang, ox, horse, cat simultaneously.General Fenbendazole can be made into mixed in the prior art
The state of suspension, but the suspension storage time is relatively short, will appear lamination after standing a period of time, in suspension
Grumeleuse is also had, generally uses water in process for preparation mid-early stage wetting agent, leads to Fenbendazole wetting not exclusively, institute in suspension
The suspending agent contained is also relatively single, and later period redispersibility can be bad, and wall built-up phenomenon is serious, and the generation of these situations can in a word
Influence the drug effect of Fenbendazole itself.
In view of this, the present invention is specifically proposed.
Summary of the invention
The first object of the present invention is to provide a kind of Fenbendazole suspension, which passes through the sweet smell to the prior art
Parbendazole suspension formula improves, so that preparing obtained Fenbendazole suspension is off-white color, uniform, muddiness, without fourth
The muddy liquid status of Da Er effect, substantially without lamination after standing a period of time, only slight layering, supernatant is colourless
Bright, lower layer's sediment is in off-white color, restores uniform again after jog, good resuspendability is presented.In addition fragrant benzene of the invention
5 months or more can be stood under room temperature environment up to azoles suspension, and can be dispersed again, bottom of bottle does not have in suspension without precipitating yet
There is any grumeleuse.
The second object of the present invention is to provide the preparation method of above-mentioned Fenbendazole suspension, and preparation method has can be complete
The advantages of whole reservation effective ingredient, and have method simply easily operated, step linking in front and back is close, and operating condition is mild etc.
Advantage.
In order to realize above-mentioned purpose of the invention, the following technical scheme is adopted:
It is main to include sweet smell in every 100ml suspension the embodiment of the invention provides a kind of formula of Fenbendazole suspension
Parbendazole 8-12g, glycerol 10-25ml, methylcellulose 0.1-0.7g, xanthan gum 0.1-1.5g, dextran-40 0-3g,
Tween-80 0.1-1.5g, Arlacel-80 0.6-1.5g, sodium benzoate 0.1-0.3g, citric acid 1-3g, water supply surplus.
In the prior art, the formula of Fenbendazole suspension is general are as follows: in every 25ml amount, Fenbendazole 1.25g, and carboxylic first
Base sodium cellulosate 0.25g, Tween-80 0.025ml, citric acid 0.25g, sodium benzoate 0.025g, distilled water is quantitative to 25ml,
It can be seen that the content of main ingredient generally only has 5% in the prior art, because if amount is easier to occur to be layered to sink after being made into very much suspension greatly
It forms sediment, influences drug effect, in addition its wetting agent used is that 1% Tween-80 (Tween-80) adds a small amount of water as wetting agent, by
It is not soluble in water in Fenbendazole and there is hydrophobicity, a small amount of water is contained in wetting agent, can Fenbendazole be swum on the water surface
Or package water becomes drop ball, so that Fenbendazole wetting is incomplete.It is only carboxymethyl there are also suspending agent used in the prior art
Sodium cellulosate, suspending agent is relatively simple to be easy to happen sedimentation, and subsequent heavy dispersion performance is bad, also has wall built-up phenomenon.
In view of many technical problems existing in the prior art, the present invention provides a kind of Fenbendazole suspensions, this is outstanding
In floating agent, the content of main ingredient from the prior art 5% be increased to 10%, and just because of unique formula of the invention, each component
Between the effect of working in coordination, the content of main ingredient does not interfere with the performance of medical fluid itself at all after improving, and the present invention uses
Organic solvent glycerol add surface active agent tween -80, Arlacel-80 as wetting agent, dosage is more, can hydrophilic close Fenbendazole,
So that wetting is completely, suspending agent is added according to a certain percentage using methylcellulose and xanthan gum as suspending agent, suspending
Effect is good, and sinking speed is slow, and is also additionally added to a certain proportion of dextran-40, can slow down the heavy of Fenbendazole
Reduction of speed degree, and can be reduced the wall built-up phenomenon of Fenbendazole suspension, at the same it is prevented from caking after it can be made to settle, it is easy to disperse again.
In addition dextran-40 has the function of expanding blood volume, can also reduce viscosity of blood, improves microcirculation, because of its molecule
Measure small, the residence time is short in vivo, and it is fast through kidney excretion, also have the function of certain diuresis, however not only leads in the prior art
The comparision contents of medicine are small, have a certain impact to drug effect, and in addition the irrationality of suspending agent, wetting agent itself is mixed to Fenbendazole
The various aspects of performance of suspension itself is also to have a certain impact, and the solution of the present invention exactly solves existing in the prior art
Various technical problems have ground-breaking meaning, in the prior art about this unique Fenbendazole suspension of the invention
Formula, there is no record, and the present invention still belongs to pioneering, and in view of the solution of the present invention, virtually improves Fenbendazole
The various aspects of performance of suspension has further widened the use scope of Fenbendazole, and should be widely promoted application.
Wherein, in the formula, suspending agent is methylcellulose and xanthan gum, and dosage, which remains basically stable, between the two works in coordination
Synthesis plays the role of suspending, and wetting agent adds surface active agent tween -80, Arlacel-80 using glycerol, and glycerol dosage is general
Maintain containing 20ml or so in every 100ml medical fluid, Tween-80, Arlacel-80 dosage remain basically stable, it is mutual according to such ratio
Main ingredient wetting can be made complete after matching addition.
In addition, in order to further increase the performance of suspension, in Fenbendazole suspension formula of the present invention, Fenbendazole 9-
11g, glycerol 15-22ml, methylcellulose 0.2-0.5g, xanthan gum 0.5-0.8g, dextran-40 0.5-2.5g, tween-
80 0.5-1.2g, Arlacel-80 0.7-1.3g, sodium benzoate 0.15-0.25g, citric acid 1.5-2.5g, water supply surplus.
More preferably, it after examination many-sided from the indexs such as settling ratio, wall built-up phenomenon, redispersibility, finds optimal
Formula rate are as follows: Fenbendazole 10g, glycerol 20ml, methylcellulose 0.3g, xanthan gum 0.7g, dextran-40 2g are spat
Temperature -80 0.7g, Arlacel-80 1.2g, sodium benzoate 0.2g, citric acid 2g, water supply surplus.
In short, there is than convenient dosage each component in formula of the invention, although these substances belong to it is existing
Common substance in technology, but the present invention protect focus on these types of component and matched between each other by specific dosage
It closes, matches by between each component mutual reasonable 5, can make the Fenbendazole suspension products prepared that there is stability
Good, sinking speed is slow, efficacy stability, is easy to shake scattered after sedimentation, does not agglomerate, not wall built-up, syringeability is good, and solubization is good, can be completely
It is soluble in water, can drug administration by injection while also can good drinking water administration, furthermore ingredient green natural, do not add it is any manually at
Point, there is no any destruction to environment and the mankind, it is environmentally protective.
The present invention additionally provides the system of the Fenbendazole suspension in addition to providing a kind of formula of Fenbendazole suspension
Preparation Method includes the following steps:
Mixed liquor is formed after Fenbendazole is mixed wetting with glycerol, Tween-80, Arlacel-80；
By sodium benzoate, citric acid, dextran-40 using after part aqueous solution, it is mixed that methylcellulose, xanthan gum is added
After being mixed after even with the mixed liquor, it is uniformly mixed after adding remaining water.
The preparation method of the Fenbendazole suspension of the embodiment of the present invention has the advantages that completely retain effective ingredient, and
And having method simply easily operated, the advantages that step linking in front and back is close, and operating condition is mild, inventor is also by repeatedly
Test the preferably preparation route finally taken.
Certainly, above-mentioned preparation method is preferably a kind of in numerous preparation methods, and not representing is uniquely to make
Preparation Method, as long as preparing the preparation method of the suspension with this effect of the present invention by using raw material of the invention,
Within the scope of the present invention.
Preferably, sodium benzoate, citric acid, dextran-40 are used into part aqueous solution, methylcellulose, Huang is added
It carries out mixing dispersion 2-3min using high speed homogenization dispersion machine after virgin rubber.Wherein, the temperature for mixing dispersion is preferably controlled in 20-30
℃。
Preferably, it after being mixed with the mixed liquor, mixes and carries out mixing dispersion 1-2min using high speed homogenization dispersion machine,
In, the temperature for mixing dispersion is preferably controlled in 20-30 DEG C.
Finally, after adding remaining water constant volume, then carry out mixing dispersion 2-3min, the step in high speed homogenization dispersion machine
The middle temperature for mixing dispersion similarly controls between 20-30 DEG C preferably.
Carrying out using when mixing dispersion in preparation method of the invention is high speed homogenization dispersion machine, so that each in suspension
The phenomenon that component obtains good dispersion, avoids particle agglomeration.
Compared with prior art, the invention has the benefit that
(1) the present invention provides a kind of Fenbendazole suspension, the suspension is mixed by the Fenbendazole to the prior art
Suspension formula improves, so that preparing obtained Fenbendazole suspension is off-white color, uniform, muddy, five Tyndall effects
Muddy liquid status, stand a period of time after substantially without lamination, only slight layering, supernatant is colorless and transparent, lower layer
Sediment is in off-white color, restores uniform again after jog, good resuspendability is presented.Fenbendazole suspension of the invention exists
5 months or more can be stood under room temperature environment, and can be dispersed again, bottom of bottle does not have any grumeleuse in suspension without precipitating yet；
(2) Fenbendazole suspension of the invention, the content of main ingredient from the prior art 5% be increased to 10%, and just
Because of the effect of working in coordination of unique formula of the invention, the content of main ingredient does not interfere with the property of medical fluid itself at all after improving
Can, and the wetting agent that the present invention uses adds surface active agent tween -80, Arlacel-80 as wetting agent, agent for organic solvent glycerol
Amount is more, and the hydrophilic close Fenbendazole of energy, so that wetting is completely, suspending agent is using methylcellulose and xanthan gum by certain ratio
Example addition is used as suspending agent, and suspending effect is good, and sinking speed is slow, and is also additionally added to a certain proportion of dextran-40,
The sinking speed of Fenbendazole and the wall built-up phenomenon of Fenbendazole suspension can be slowed down, further widened sweet smell
The use scope of parbendazole, should be widely promoted application；
(3) preparation method of Fenbendazole suspension of the invention has the advantages that completely retain effective ingredient, and
Simply easily operated with method, the advantages that step linking in front and back is close, and operating condition is mild, inventor is also by repeatedly real
Test the preferably preparation route finally taken.
Specific embodiment
Embodiment of the present invention is described in detail below in conjunction with embodiment, but those skilled in the art will
Understand, the following example is merely to illustrate the present invention, and is not construed as limiting the scope of the invention.It is not specified in embodiment specific
Condition person carries out according to conventional conditions or manufacturer's recommended conditions.Reagents or instruments used without specified manufacturer is
The conventional products that can be obtained by commercially available purchase.
Embodiment 1
Fenbendazole suspension the preparation method is as follows:
1) recipe quantity: Fenbendazole 8g, glycerol 22ml, methylcellulose 0.2g, xanthan gum 0.1g, Tween-80 1.5g,
Arlacel-80 1.5g, sodium benzoate 0.1g, citric acid 1g, water are quantitative to 100ml；
2) Fenbendazole of recipe quantity is weighed, glycerol, Tween-80, Arlacel-80 wetting is added, it is to be moistened complete；
3) 50ml water is taken, sodium benzoate, citric acid stirring and dissolving is added, adds methylcellulose and is dispersed with high speed homogenization
Machine disperses 2min；
4) 3) mixed liquor of step and the mixed liquor of 2) step are mixed evenly, are dispersed with high speed homogenization dispersion machine
1min, adds water quantitative to 100ml, with high speed homogenization dispersion machine dispersion 2min to get.
Embodiment 2
Fenbendazole suspension the preparation method is as follows:
1) recipe quantity: Fenbendazole 12g, glycerol 10ml, methylcellulose 0.1g, xanthan gum 0.8g, dextran-40
3g, Tween-80 0.5g, Arlacel-80 0.6g, sodium benzoate 0.3g, citric acid 3g, water are quantitative to 100ml；
2) Fenbendazole of recipe quantity is weighed, glycerol, Tween-80, Arlacel-80 wetting is added, it is to be moistened complete；
3) take 50ml water, sodium benzoate, citric acid, dextran-40 stirring and dissolving be added, add methylcellulose,
Xanthan gum disperses 3min with high speed homogenization dispersion machine, and temperature is controlled at 30 DEG C；
4) 3) mixed liquor of step and the mixed liquor of 2) step are mixed evenly, with 20 DEG C points of high speed homogenization dispersion machine
Dissipate 2min, add water quantitative to 100ml, with 30 DEG C of dispersion 3min of high speed homogenization dispersion machine to get.
Embodiment 3
Fenbendazole suspension the preparation method is as follows:
1) recipe quantity: Fenbendazole 9g, glycerol 15ml, methylcellulose 0.7g, xanthan gum 0.1g, dextran-40
2.5g, Tween-80 0.7g, Arlacel-80 0.7g, sodium benzoate 0.25g, citric acid 2.5g, water are quantitative to 100ml；
2) Fenbendazole of recipe quantity is weighed, glycerol, Tween-80, Arlacel-80 wetting is added, it is to be moistened complete；
3) take 50ml water, sodium benzoate, citric acid, dextran-40 stirring and dissolving be added, add methylcellulose,
Xanthan gum disperses 3min with high speed homogenization dispersion machine, and temperature is controlled at 20 DEG C；
4) 3) mixed liquor of step and the mixed liquor of 2) step are mixed evenly, with 30 DEG C points of high speed homogenization dispersion machine
Dissipate 2min, add water quantitative to 100ml, with 20 DEG C of dispersion 3min of high speed homogenization dispersion machine to get.
Embodiment 4
Fenbendazole suspension the preparation method is as follows:
1) recipe quantity: Fenbendazole 11g, glycerol 25ml, methylcellulose 0.3g, xanthan gum 0.7g, dextran-40
0.5g, Tween-80 1.2g, Arlacel-80 1.3g, sodium benzoate 0.15g, citric acid 1.5g, water are quantitative to 100ml；
2) Fenbendazole of recipe quantity is weighed, glycerol, Tween-80, Arlacel-80 wetting is added, it is to be moistened complete；
3) take 50ml water, sodium benzoate, citric acid, dextran-40 stirring and dissolving be added, add methylcellulose,
Xanthan gum disperses 2.5min with high speed homogenization dispersion machine, and temperature is controlled at 25 DEG C；
4) 3) mixed liquor of step and the mixed liquor of 2) step are mixed evenly, with 25 DEG C points of high speed homogenization dispersion machine
Dissipate 1.5min, add water quantitative to 100ml, with 25 DEG C of dispersion 2.5min of high speed homogenization dispersion machine to get.
Embodiment 5
Fenbendazole suspension the preparation method is as follows:
1) recipe quantity: Fenbendazole 10g, glycerol 20ml, methylcellulose 0.5g, xanthan gum 0.5g, dextran-40
2g, Tween-80 1g, Arlacel-80 1.2g, sodium benzoate 0.2g, citric acid 2g, water are quantitative to 100ml；
Remaining step and embodiment 4 are almost the same.
Comparative example 1
Fenbendazole suspension the preparation method is as follows:
1) recipe quantity: Fenbendazole 1.25g, sodium carboxymethylcellulose 0.25g, Tween-80 0.025ml, citric acid
0.25g, sodium benzoate 0.025g, distilled water are quantitative to 25ml；
Remaining step and embodiment 4 are almost the same, and the formula ratio is from " Zhang Fenli, Xibei Univ. of Agricultural & Forest Science & Technology, fragrant benzene
In this document of preparation and its quality control up to azoles suspension ".
Experimental example 1
The performance for the Fenbendazole suspension that 1-5 of the embodiment of the present invention is prepared with comparative example 1 is detected, specifically
Testing result is as shown in table 1 below；
Wherein, it is sedimentation volume ratio F (F=H/H that settling ratio is practical0) (the Chinese Pharmacopoeia committee 2010；Ministry of Agriculture's novel chiral synthon
Evaluation committee 2001)；
Redisperse experiment: the Fenbendazole suspension after storage is placed in the graduated cylinder of 100ml, with the speed of 20 r/min
Rotation, after the rotation of certain time, if the sediment of graduated cylinder bottom can be uniformly dispersed again, illustrates the suspension
Redispersibility it is good；Conversely, then the redispersibility of the suspension can be poor, and observe wall built-up phenomenon.
Experimental example 2
The screening of best prescription, tested number 100ml determine that Fenbendazole is 10g, sodium benzoate 0.2g, citric acid
For 2g, the following several groups of horizontal factors experiment of design such as table 1, experimental result is as shown in table 2:
1 experiment condition of table
2 experimental result of table
From Table 2, it can be seen that the 3rd, 5,9 group of stability is preferable, and it is not easily settled, meet the suspension quality of States Pharmacopoeia specifications
Control standard.According to redispersibility measurement result and wall built-up situation as a result, using the 9th group of prescription as 10% Fenbendazole suspension
Final prescription.I.e. the best prescription of the suspension is (amount of 100ml): Fenbendazole, sodium benzoate, citric acid, glycerol, first
Base cellulose, xanthan gum, dextran-40, Tween-80, Arlacel-80 be respectively as follows: 10g, 0.2g, 2g, 20ml, 0.5g,
0.5g, 2g, 1.0g and 1.2g.This product stability is good, and sinking speed is slow, just slightly settles after 7 days, and final after placement three months
Settling ratio can reach 0.5 or more, be easy to shake scattered after sedimentation, not agglomerate, not wall built-up.This product syringeability is good, and solubization is good, can be completely
It is soluble in water, can drug administration by injection while also can good drinking water administration.
Although illustrate and describing the present invention with specific embodiment, it will be appreciated that without departing substantially from of the invention
Many other change and modification can be made in the case where spirit and scope.It is, therefore, intended that in the following claims
Including belonging to all such changes and modifications in the scope of the invention.
Claims (8)
1. a kind of Fenbendazole suspension, which is characterized in that in every 100ml suspension, include Fenbendazole 10g, glycerol 20ml,
Methylcellulose 0.5g, xanthan gum 0.5g, dextran-40 2g, Tween-80 1g, Arlacel-80 1.2g, sodium benzoate
0.2g, citric acid 2g, water supply surplus.
2. a kind of preparation method of Fenbendazole suspension described in claim 1, which comprises the steps of:
Mixed liquor is formed after Fenbendazole is mixed wetting with glycerol, Tween-80, Arlacel-80；
After sodium benzoate, citric acid, dextran-40 are used part aqueous solution, after methylcellulose, xanthan gum mixing is added
It mixes with the mixed liquor, is uniformly mixed after adding remaining water.
3. a kind of preparation method of Fenbendazole suspension according to claim 2, which is characterized in that by sodium benzoate,
Citric acid, dextran-40 use part aqueous solution, be added methylcellulose, after xanthan gum using high speed homogenization dispersion machine into
Row mixes dispersion 2-3min.
4. a kind of preparation method of Fenbendazole suspension according to claim 3, which is characterized in that by sodium benzoate,
Citric acid, dextran-40 use part aqueous solution, and the temperature control that dispersion is mixed after addition methylcellulose, xanthan gum exists
20-30℃。
5. a kind of preparation method of Fenbendazole suspension according to claim 3, which is characterized in that with the mixed liquor
After mixing, mixes and carry out mixing dispersion 1-2min using high speed homogenization dispersion machine.
6. a kind of preparation method of Fenbendazole suspension according to claim 5, which is characterized in that with the mixed liquor
After mixing, the temperature for mixing dispersion is controlled at 20-30 DEG C.
7. a kind of preparation method of Fenbendazole suspension according to claim 2, which is characterized in that after adding remaining water
It carries out mixing dispersion 2-3min in high speed homogenization dispersion machine again.
8. a kind of preparation method of Fenbendazole suspension according to claim 7, which is characterized in that after adding remaining water
The temperature for mixing dispersion is controlled at 20-30 DEG C.
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| CN109528646A (en) * | 2018-11-21 | 2019-03-29 | 南京泽恒医药技术开发有限公司 | A kind of mercaptopurine suspension and preparation method thereof |
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| WO1995013065A1 (en) * | 1993-11-10 | 1995-05-18 | Hoechst-Roussel Agri-Vet Company | Fenbendazole formulations |
| CN102440953A (en) * | 2011-12-29 | 2012-05-09 | 郑国祥 | Albendazole suspension preparation and preparation method thereof |
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| WO1995013065A1 (en) * | 1993-11-10 | 1995-05-18 | Hoechst-Roussel Agri-Vet Company | Fenbendazole formulations |
| CN102440953A (en) * | 2011-12-29 | 2012-05-09 | 郑国祥 | Albendazole suspension preparation and preparation method thereof |
| CN105982854A (en) * | 2015-01-28 | 2016-10-05 | 河南惠通天下生物工程有限公司 | Fenbendazole nano suspension and preparation method thereof |
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| 芬苯达唑混悬剂的制备与含量测定方法的建立;张粉丽等;《动物医学进展》;20151231;第36卷(第9期);第76-79页 |
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| CN106727304A (en) | 2017-05-31 |
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Denomination of invention: Fenbendazole suspension and preparation method thereof Effective date of registration: 20191224 Granted publication date: 20190903 Pledgee: Bank of Communications Limited Jiujiang Branch Pledgor: JIANGXI BOLAI PHARMACY CO., LTD. Registration number: Y2019360000048 |
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