CN110292561A - A kind of oral pharmaceutical solutions formula and preparation with Anti-human globulin test - Google Patents
A kind of oral pharmaceutical solutions formula and preparation with Anti-human globulin test Download PDFInfo
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- CN110292561A CN110292561A CN201910653373.1A CN201910653373A CN110292561A CN 110292561 A CN110292561 A CN 110292561A CN 201910653373 A CN201910653373 A CN 201910653373A CN 110292561 A CN110292561 A CN 110292561A
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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
- A61K31/53—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with three nitrogens as the only ring hetero atoms, e.g. chlorazanil, melamine
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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
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
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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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
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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
- A61P33/02—Antiprotozoals, e.g. for leishmaniasis, trichomoniasis, toxoplasmosis
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The oral pharmaceutical solutions formula and preparation that the present invention relates to a kind of with Anti-human globulin test, and in particular to bioactive lipophilic drug improves water-soluble combination formula by combination formula.Its specific combination formula be by one of drug and organic solvent or it is a variety of mix, then mixed with plurality of stable agent.Pharmaceutical dosage form is made by the manufacturing method of usual pharmaceutical dosage form in composite formula.Clinical use pharmaceutical dosage form made of above method is diluted in proportion with water after with poultry drinking water administration, increase dissolubility and stability in drug water, increase drug absorption and improve bioavilability.
Description
Technical field
The present invention relates to the formula combination and preparation of a kind of anticoccidial drug solution, particularly relate to a kind of prepare Sha Mizhu
The method of sharp solution belongs to veterinary drug technical field.
Background technique
Chicken coccidiasis is that acute popularity parasitic disease, cause of disease as caused by one or more coccidias are the Amy in protozoon
The coccidia of otology Eimeria, it is recognized that have 7 worm kinds, wherein Eimeria tenella (Eimeria tenella), poison Chinese mugwort
U.S. ear ball worm (Eimeria necatrix), heap-type Eimeria (Eimeria acervulina) and huge Amy ear ball
The pathogenicity of worm (Eimeria maxima) is stronger, is the main reason for causing clinical globidiosis to occur.
Husky miaow pearl benefit is a kind of new triazines anticoccidial by China Agriculture Academe Shanghai Veterinary Institute's independent research
Medicine, with diclazuril, toltrazuril without cross resistance, and compared with toltrazuril gram pearl benefit, anticoccidial effect is more bright
It is aobvious, no egg capsule and lesion.Husky miaow pearl benefit is the anti-ball of brand new developed on the basis of early period is to triazine system research
Worm compound, preclinical safety, study on the efficiency show that it, with good druggability basis, faces referring to coccidiostat
The guide of bed pharmacodynamic test and related mature animal model have carried out multiple batches of dose screening test.Sha Mizhu in feed
Sharp additive capacity 5-15mg/kg shows good anti-Eimeria species activity, and when additive capacity is greater than 9mg/kg, each group is entirely reached
The level of efficient coccidiostat, can react the coccidiostat activity and dose-effect relationship of noval chemical compound sand miaow pearl benefit.It is husky
Miaow pearl benefit prevents what these common causative worm strains caused as it can be seen that husky miaow pearl benefit has to the sensitivity tests result of common Eimeria species
The average anticoccidial index of the curative effect of globidiosis, globidiosis caused by, murder by poisoning tender to prevention chicken and heap-type Eimeria is equal
Value is respectively 197,188,194 and 190, reaches high efficiency levels.Since clinical chicken coccidiasis is generally mostly the mixed of different worm strains
It closes infection to cause, therefore, the anticoccidial characteristic of wide spectrum has great importance for novel anticoccidial drug exploitation, thus pushes away
It surveys, husky miaow pearl benefit has preferable development and application prospect.
Veterinary drug solution is that drug is dissolved in solvent formation supernatant liquid, by the drinking water for being added to livestock and poultry in proportion
In, convenient drug administration, good absorption effect, bioavilability height.Husky miaow pearl benefit is insoluble in water, and water solubility is poor, can not be direct
It is mixed with aqueous solution, therefore in preparation research, is first prepared into the organic solvent of high concentration, then mixed in proportion with water
It closes, solubilising is carried out to husky miaow pearl benefit using surfactant, organic solvent hydrotropy increases medicine stability.The country there is no the production
Product listing, thus studied and inquired into its detection method, safety in utilization to the preparation method of husky miaow pearl benefit solution and face
Bed drug effect etc. is very necessary.
Summary of the invention
It is an object of the invention to overcome the shortcomings of that husky miaow pearl benefit water-soluble is poor, a kind of suitable drinking water administration is provided, is made
With convenient and stable anticoccidial drug combination formula.
The technical scheme adopted by the invention is as follows: a kind of pharmaceutical composition of coccidiostat, it is characterised in that: the drug
Composition includes that drug and the auxiliary material for the stable in physicochemical property that can make effective ingredient form;Auxiliary material include: organic solvent,
Solubilizer, antioxidant and stabilizer, in pharmaceutical composition: medicament contg be the content of 1%-5% organic solvent be 60%~
80%, the content of solubilizer is 10%~30%, antioxidant content 0.1%-0.5%, and stabilizer is 1%~5%.
Polyethylene glycol, propylene glycol, ethylene glycol, the one or more combinations of ethyl alcohol are selected from as the preferably described organic solvent;
Solubilizer preferred polysorbas20, polysorbate60, Tween 80, sapn, sells pool at polysorbate40;Stabilizer is preferably ammonium hydroxide, diethylamine, ethyl alcohol
Amine, triethanolamine, sodium hydroxide, sodium citrate;The preferred butylhydroxy anisole of antioxidant (BHA), dibutyl hydroxy toluene
(BHT);
Drug solution formula with coccidiostat activity of the invention the preparation method is as follows:
Drug ingedient and organic solvent and solubilizer is taken to be heated to 60~80 DEG C, stirring to complete drug dissolution stops adding
Heat is placed to room temperature (10~35 DEG C), and stabilizer and antioxidant is added, and stirring is extremely dissolved, supplement organic solvent to recipe quantity.
Specific implementation method:
Further illustrate the present invention with reference to embodiments, but embodiment does not do any type of limit to the present invention
System:
1 coccidiostat formula combination preparation method of embodiment
1. pharmaceutical formulation combination and preparation method
1 anticoccidial drug formula combination of table and solubility property
Preparation method:
(1) drug, organic solvent and solubilizer are mixed by each component in table 1,70 DEG C ± 5 DEG C is heated with stirring to, until medicine
Object is completely dissolved, and is let cool to room temperature and is obtained mixed liquor 1;
(2) stabilizer and antioxidant are taken, is added to and lets cool into 1 liquid of mixing of room temperature, stirring to dissolution;
(3) ethyl alcohol is added to 100mL, is prepared into the pharmaceutical formulation combination with anticoccidial performance;
(4) filtering packing is into the high-density polyethylene bottle oral liquid bottle with sealing film.
Water-soluble test: each formulation samples are taken, adding water to drug concentration is respectively 10ppm and 1000ppm, is placed at room temperature for
Whether 4h observation drug in solution, which dissolves situation and be precipitated, the results are shown in Table 1.
The formula combination drug of anticoccidial drug solution in this patent is husky miaow pearl benefit, rear to claim husky miaow pearl benefit solution, below
The husky miaow pearl benefit solution mentioned in embodiment is product in this patent.
2 stability test of embodiment
The formula combination drug of anticoccidial drug solution is husky miaow pearl benefit, rear to claim husky miaow pearl benefit solution, to produce in this patent
Product.
In drug research, for the stability for monitoring drug, for its content under opposite drastic conditions, related substance etc.
The variation of property understands the factor for influencing its stability and possible explanation approach and catabolite, produces work for pharmaceutical preparation
Skill, packaging, storage requirement and establish degradation product analysis method provide scientific basis, be the essential a part of new drug research,
General condition of investigating is three high temperature, high humidity and illumination conditions.
Pharmaceutical formulation 2 in Example 1 only investigates high temperature and illumination 2 since product is liquid preparation in this patent
Stability under the conditions of a:
(1) hot test: husky miaow pearl benefit solution is placed in commercially available back, is placed 10 at a temperature of 60 DEG C, on 5th and
It samples within 10th, is detected by study on the stability project.
(2) exposure experiments to light: husky miaow pearl benefit solution is placed in transparent tool plug conical flask, in 4500 ± 500Lx intensity
It is respectively placed in the 5th day and the 10th day and samples under light irradiation, detected by study on the stability project.
(3) test result is shown in Table 2 and table 3:
2 high temperature experimental result of table (60 DEG C)
The husky miaow pearl benefit solution illumination experiment result (4500 ± 500Lx) of table 3
Test result shows that the husky miaow pearl benefit solution under placing by drastic conditions is steady under illumination and hot conditions
It is fixed, indicate content, pH value, in relation to substance and moisture, there is no significant changes.
The coccidiostat activity of the husky miaow pearl benefit solution of embodiment 3
Chicken coccidiasis is acute popularity parasitic disease, the anticoccidial of clinical prevention as caused by one or more coccidias
Pharmaceutical preparation is mainly pre-mixing agent, and husky miaow pearl benefit is a kind of novel chiral synthon completely newly developed, and suitable preparation technique and dosage form can be with
The bioavilability for promoting drug, facilitates clinical use and generates bigger economic results in society.In view of husky miaow pearl benefit is all
Triazines anticoccidial compound, but physicochemical property shows it with speciality such as better water-solubles, to give full play to the drug
Potential quality, preferably maximize favourable factors and minimize unfavourable ones and play the effect of it should have, improve bioavilability.
This research has carried out husky miaow pearl benefit solution compared with Baycox (toltrazuril solution) coccidiostat activity, toltrazuril
For commercially available import anticoccidial drug, to heap-type, Podbielniak, it is huge, gentle, poison, Eimeria Tenella and turkey gland shape Amy
That coccidia, turkey eimeria tenella, the small eimeria tenella of turkey have killing effect.Coccidia schizogenesis is mainly acted on to grow and gamete
Reproductive phase.Dosage is 25ppm.Select No. 2 formulas in embodiment 1 compared with toltrazuril carries out drug effect, ACI is anti-
Coccidia index, ACI=(body weight increase rate+survival rate)-(pathological changes value+oocyst value).By the method for United States Merck company, ACI >=
180 are judged to sensitivity, 160≤ACI < 180 be it is good, 120≤ACI < 160 be it is poor, ACI < 120 is invalid.Detailed results are seen below
Table 4.
The husky miaow pearl benefit pharmaceutical solutions of table 4 are compared with the coccidiostat activity of toltrazuril
Test result shows, husky miaow pearl benefit solution drinking water administration, and the average anticoccidial index of high, medium and low dosage is respectively
178,174 and 180, equally horizontal close to efficient coccidiostat, the average anticoccidial of control drug toltrazuril solution preparation
Index is respectively 165, and the whole drug effect of husky miaow pearl benefit solution is relatively more slightly higher than the drug effect of toltrazuril solution preparation.Illustrate husky miaow
Pearl benefit solution has good anti-Eimeria species effect, and anticoccidial effect is with traditional mixed feeding administration mode without apparent poor
Different, in clinical test, the mode that can substitute traditional pre-mixing agent mixed feeding is administered, and facilitates clinical use, and clinical use pushes away
Recommend the mixed drink of dosage 10ppm.
The husky miaow pearl benefit drug in solution dynamic metabolism test of embodiment 4
Yellow-feather broiler presses 0.67,1.33 and 6.67mg/Kgb.w. (according to the daily dose lonvestion of every chicken of solution)
After oral sand miaow pearl benefit solution, learn that pharmacokinetic parameters are shown in Table 5-7 through the non-compartment model Fitting Analysis of DAS3.0:
The pharmacokinetic parameter (mean ± SD, n=12) of husky miaow pearl benefit under 5 various dose of table
It can be seen that the main pharmacokinetic parameters C of the husky miaow pearl benefit of various dosemaxWith AUC with the increasing of dosage
Add and increase, by its CmaxLinear regression is carried out to dosage respectively with AUC.This test result shows in 0.67~6.7mg/
In kg bw dosage range, which shows as linear dynamics in yellow-feather broiler body.
The C of husky miaow pearl benefit under 6 various dose of tablemaxWith AUC (mean ± SD, n=12)
The C of husky miaow pearl benefit under 7 various dose of tablemaxWith the regression equation of AUC and dosage
Although the preferred embodiments of the invention are demonstrated and have been described herein, for those skilled in the art
These apparent embodiments are only provided in an exemplary fashion for member.Those skilled in the art is not departing from this hair
It is contemplated that a large amount of transformation, variation and replacement in the case where bright.It is understood that invention as described herein embodiment is a variety of
Different alternative solutions can be used for implementing the present invention.Following claims intent definition the scope of the present invention and these rights
Therefore method and structure and their equivalent in claimed range are covered in.
Claims (8)
1. a kind of pharmaceutical composition of coccidiostat, it is characterised in that: described pharmaceutical composition includes drug and can be so as to medicine
The auxiliary material of the stable in physicochemical property of object effective component forms;Wherein drug ingedient is husky miaow pearl benefit, and structural formula is as follows:Molecular formula C18H16N4O4Molecular weight 352.35, chemical name: N- [4- [4- (4,5-
Dioxo 4,5- dihydro -1,2,4- triazine ring-(3H)-base -2- methylphenoxy) phenyl-acetamides are a kind of with anticoccidial
Active compound in triazine class.
2. pharmaceutical composition according to claim 1, auxiliary material includes: organic solvent, solubilizer, antioxidant and stabilizer,
In pharmaceutical composition: the content of medicament contg 1%-5%, organic solvent are 60%~80%, and the content of solubilizer is
10%~30%, antioxidant content 0.1%-0.5%, stabilizer are 1%~5%.
3. composite formula according to claim 2, wherein organic solvent is selected from polyethylene glycol, propylene glycol, ethylene glycol, second
Alcohol is one or more;Solubilizer is fat-soluble nonionic surface active agent, is selected from polysorbas20, polysorbate40, polysorbate60, tween
80, sapn, sell pool;Stabilizer is selected from ammonium hydroxide, diethylamine, ethanol amine, sodium hydroxide, triethanolamine, sodium citrate;Antioxidant choosing
From butylhydroxy anisole (BHA), dibutyl hydroxy toluene (BHT).
4. the preparation process of pharmaceutical composition described in one of claims 1 to 3, the preparation process is to take above-mentioned content
Drug ingedient and solubilizer and appropriate organic solvent are mixed and heated to 60~80 DEG C, and stirring to complete drug dissolution stops heating
Placement to room temperature (10~35 DEG C), addition stabilizer and antioxidant, stirring is extremely dissolved, supplement residue organic solvent to recipe quantity,
Filtering packing.
5. according to claim 1 to pharmaceutical composition described in one of 3, it is characterised in that pH value is in 7- after being diluted with water 100 times
9。
6. according to claim 1 to pharmaceutical composition described in one of 3, it is characterised in that moisture content is less than 1.0%.
7. according to claim 1 to pharmaceutical composition described in one of 3, it is characterised in that be diluted with water 10 times~1000 times, protect
It holds and stablizes within 4 hours, solid is not precipitated.
8. pharmaceutical composition described in one of claims 1 to 3 is preparing the application in water-soluble coccidiostat.
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Cited By (4)
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---|---|---|---|---|
CN111658605A (en) * | 2020-06-29 | 2020-09-15 | 天津市中升挑战生物科技有限公司 | Saimiqili solution preparation and preparation method thereof |
CN114404361A (en) * | 2022-01-28 | 2022-04-29 | 中牧全药(南京)动物药品有限公司 | Sanglizhuli solution and preparation method thereof |
CN114886854A (en) * | 2022-05-19 | 2022-08-12 | 中国农业科学院上海兽医研究所 | Saimiqili soluble powder and preparation method thereof |
CN116173038A (en) * | 2022-12-20 | 2023-05-30 | 天津市中升挑战生物科技有限公司 | Cimetidine preparation and preparation method thereof |
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Cited By (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN111658605A (en) * | 2020-06-29 | 2020-09-15 | 天津市中升挑战生物科技有限公司 | Saimiqili solution preparation and preparation method thereof |
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CN116173038A (en) * | 2022-12-20 | 2023-05-30 | 天津市中升挑战生物科技有限公司 | Cimetidine preparation and preparation method thereof |
CN116173038B (en) * | 2022-12-20 | 2024-08-02 | 天津市中升挑战生物科技有限公司 | Cimetidine preparation and preparation method thereof |
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