CN104274397A - Suspension containing pidotimod, and preparation method thereof - Google Patents
Suspension containing pidotimod, and preparation method thereof Download PDFInfo
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- CN104274397A CN104274397A CN201310277663.3A CN201310277663A CN104274397A CN 104274397 A CN104274397 A CN 104274397A CN 201310277663 A CN201310277663 A CN 201310277663A CN 104274397 A CN104274397 A CN 104274397A
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- pidotimod
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- suspension
- suspending agent
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Abstract
The invention belongs to the technical fields of immunopotentiators for animals, and preparation methods thereof, and concretely relates to a suspension containing pidotimod, and a preparation method thereof. The above preparation comprises a pidotimod bulk drug, a suspending aid, a wetting agent, an antiseptic and a flocculating agent. The suspension containing pidotimod is prepared through a dispersion process, and is an off-white sticky water suspension. The suspension containing pidotimod developed in the invention has the advantages of good stability, good palatability, long elimination half life, and high bioavailability, and can be used by animals as an oral preparation.
Description
Technical field
The invention belongs to immunostimulant for animals and preparation method technical field, be specifically related to a kind of preparation method of suspending agent of pidotimod.
Technical background
Current cultivation industry is along with the continuous expansion of scale, and intensive degree is more and more higher, and breeding environment pollutes day by day serious, and various disease frequently occurs.Therefore, adopt various measures to improve Abwehrkraft des Koepers to prevent disease and seem particularly important.Antibiotic has good curative effect really to some disease, but there is no effect to the disease that virus causes, and easy excessive use, even abuse.Vaccine has significant preventive effect for various diseases especially viral disease, but specificity is comparatively strong, and it is produced, operation possibility is looked into.Compare with the development of vaccine with antibiotic, immunostimulant have that development cost is low, the advantage such as applied range, use safety, side effect are little, therefore the immunostimulant of developing green, nontoxic pollution-free becomes current study hotspot.
Pidotimod, the immunostimulant researched and developed by Italian Poli company, within 1993, listing chemical name is (R)-3-[(s)-(5-oxygen-2-pyrrolidinyl) carboxyl]-tetrahydro-thiazoles-4-carboxylic acid, be a kind of new bio reaction control agent of thymus dipeptide structure of synthetic, all there is immunostimulatory activity to animal and human.By stimulating nonspecific innate immunity, humoral immunization and cellular immunization produce immunomodulatory effect.Pidotimod is soluble in water, can orally also can inject.Stable in physicochemical property, is not easy various enzyme in body and decomposes, effectively can penetrate in tissue and play immunostimulation, is the immune drugs knowing its bioavailability few in number at present.Have the research that the pharmacodynamics, pharmacology, toxicology etc. of numerous scholar to this medicine carry out both at home and abroad, and carry out a large amount of clinical trials.The clinical observation of this medicine in many medical institutions through thousands of example, prove that this medicine can be used for the respiratory tract infection, condyloma acuminatum, vitiligo, chronic hepatitis etc. of child and old man, the various diseases of immunologic hypofunction can also be used for, fully showing pidotimod as a kind of immunostimulant, is a kind of very promising product.Pidotimod is soluble in water, can orally also can inject.Stable in physicochemical property, is not easy various enzyme in body and decomposes, effectively can penetrate in tissue and play immunostimulation, is the immune drugs knowing its bioavailability few in number at present.Pidotimod itself does not have antibacterial activity, but share with antimicrobial drug, effectively can improve clinical symptoms and the sign of infected patient.It is acute and chronic toxic effect is all very low, and zoopery Canis familiaris L. has no any toxic reaction for 6 months with the 40-50 times of oral successive administration of the highest therapeutic dose.Research pidotimod oral formulations is significant for the use of veterinary clinic immunostimulant.
Pidotimod is utilized water suspendible oral liquor by prominent features of the present invention exactly, is prepared into oral suspension agent for animals.The pidotimod suspensions stability prepared by this method is good, good palatability, the assimilation effect that tool is good, for China's veterinary clinic utilizes pidotimod to provide a kind of new preparation better.
Summary of the invention
The object of the invention is to develop the agent of a kind of pidotimod oral suspension, heighten the effect of a treatment, improve stability and the palatability of medicine, tool long-acting.
The present invention, for achieving the above object, provides a kind of aqueous suspension agent containing pidotimod, it is characterized in that preparation specifically consists of:
(a) pidotimod crude drug 2-10% (W/V);
(b) suspending agent 0.1-2.0% (W/V);
(c) wetting agent 5-20% (W/V);
(d) antiseptic 0.05-0.50% (W/V);
(e) flocculating agent 0.1-1% (W/V);
Described a kind of suspending agent containing pidotimod, is characterized in that the preparation invented is based on water, and the polyhydric alcohol that can mix with water arbitrary proportion, as ethylene glycol, propylene glycol, glycerol, particularly preferably propylene glycol.
The suspending agent of described a kind of pidotimod, it is characterized in that Polyethylene Glycol, castor oil hydrogenated that described suspending agent preferably carboxymethyl cellulose (sodium), methylcellulose, tragakanta, xanthan gum, polyvinylpyrrolidone, molecular weight are greater than 1000, preferred xanthan gum.
Described a kind of suspending agent containing pidotimod, is characterized in that the preferred poly yamanashi esters of described wetting agent, spans, glycerol, propylene glycol, polyoxyethylene castor oil, poloxamer, preferential poloxamer.
Described a kind of suspending agent containing pidotimod, it is characterized in that described antiseptic is: benzyl alcohol, benzalkonium chloride, p-hydroxy Benzoic Acid ester, n-butyl alcohol, benzoic acid, citric acid, sorbic acid, sodium benzoate, sodium propionate, preferred sodium benzoate or sodium propionate.
Described a kind of suspending agent containing pidotimod, is characterized in that described flocculating agent is: a certain in citrate (acid salt or normal salt), tartrate (acid salt or normal salt), phosphate, optimization citric acid.
Described a kind of suspending agent containing pidotimod, is characterized in that preparation method is as follows:
Measure pidotimod and purified water and antiseptic, wetting agent according to prescription to stir formation suspension, separately get recipe quantity suspending agent add appropriate purified water swelling after, gradation adds in above-mentioned suspension, with adding with stirring, add after flocculating agent water dissolution, finally add water to recipe quantity, stir evenly at a high speed, obtained water suspendible oral liquid.
Detailed description of the invention
Be explained the present invention with example below, but example does not limit the scope of the invention, scope of the present invention and core content are determined according to claims.
Example: 10% pidotimod aqueous suspension agent
[prescription] pidotimod 10% (W/V)
Tragakanta 0.75% (W/V)
Propylene glycol 15% (W/V)
Poloxamer 0.2% (W/V)
Sodium benzoate 0.3% (W/V)
Pure water adds to 100% (V/V)
[preparation]
Get prescription and measure pidotimod and above-mentioned various adjuvant is aseptically prepared according to aforementioned preparation process, by colloid mill, i.e. obtained pidotimod aqueous suspension agent.
Claims (5)
1., containing a suspending agent for pidotimod, it is characterized in that preparation specifically consists of:
(a) suspending agent 0.1-2.0% (W/V);
(b) wetting agent 5-20% (W/V);
(c) antiseptic 0.05-0.50% (W/V);
(d) flocculating agent 0.1-1% (W/V);
By a kind of suspending agent containing pidotimod according to claim 1, it is characterized in that the preparation invented is based on water, and the polyhydric alcohol that can mix with water arbitrary proportion, as ethylene glycol, propylene glycol, glycerol, particularly preferably propylene glycol.
2. by the suspension of a kind of pidotimod according to claim 1, it is characterized in that Polyethylene Glycol, castor oil hydrogenated that described suspending agent preferably carboxymethyl cellulose (sodium), methylcellulose, tragakanta, xanthan gum, polyvinylpyrrolidone, molecular weight are greater than 1000, preferred xanthan gum.
3. a kind of suspension containing pidotimod described in, is characterized in that the preferred poly yamanashi esters of described wetting agent, spans, glycerol, propylene glycol, polyoxyethylene castor oil, poloxamer, preferred poloxamer.
4. by a kind of suspension containing pidotimod according to claim 1, it is characterized in that described antiseptic is: benzyl alcohol, benzalkonium chloride, p-hydroxy Benzoic Acid ester, n-butyl alcohol, benzoic acid, citric acid, sorbic acid, sodium benzoate, sodium propionate, preferred sodium benzoate or sodium propionate.
5. a kind of suspending agent containing pidotimod described in, is characterized in that preparation method is as follows:
Measure pidotimod and pure water and propylene glycol according to prescription to stir formation suspension, separately get recipe quantity xanthan gum (or sodium carboxymethyl cellulose, tragakanta etc.) add appropriate pure water swelling after, gradation adds in above-mentioned suspension, with adding with stirring, finally add water to recipe quantity, stir evenly at a high speed, obtained water suspendible oral liquid.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310277663.3A CN104274397A (en) | 2013-07-04 | 2013-07-04 | Suspension containing pidotimod, and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310277663.3A CN104274397A (en) | 2013-07-04 | 2013-07-04 | Suspension containing pidotimod, and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN104274397A true CN104274397A (en) | 2015-01-14 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201310277663.3A Pending CN104274397A (en) | 2013-07-04 | 2013-07-04 | Suspension containing pidotimod, and preparation method thereof |
Country Status (1)
| Country | Link |
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| CN (1) | CN104274397A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108653207A (en) * | 2018-06-25 | 2018-10-16 | 长沙市如虹医药科技股份有限公司 | A kind of Pidotimod dry suspension and preparation method thereof |
| CN113855797A (en) * | 2021-11-19 | 2021-12-31 | 安徽科技学院 | Diluent of veterinary immunity vaccine and its preparing method |
-
2013
- 2013-07-04 CN CN201310277663.3A patent/CN104274397A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108653207A (en) * | 2018-06-25 | 2018-10-16 | 长沙市如虹医药科技股份有限公司 | A kind of Pidotimod dry suspension and preparation method thereof |
| CN113855797A (en) * | 2021-11-19 | 2021-12-31 | 安徽科技学院 | Diluent of veterinary immunity vaccine and its preparing method |
| CN113855797B (en) * | 2021-11-19 | 2023-11-10 | 安徽科技学院 | Diluent for veterinary immune vaccine and preparation method thereof |
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Legal Events
| Date | Code | Title | Description |
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| C06 | Publication | ||
| PB01 | Publication | ||
| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
| WD01 | Invention patent application deemed withdrawn after publication |
Application publication date: 20150114 |