CN105999287A - Vaccine diluent and preparation method thereof - Google Patents

Vaccine diluent and preparation method thereof Download PDF

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Publication number
CN105999287A
CN105999287A CN201610504307.4A CN201610504307A CN105999287A CN 105999287 A CN105999287 A CN 105999287A CN 201610504307 A CN201610504307 A CN 201610504307A CN 105999287 A CN105999287 A CN 105999287A
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CN
China
Prior art keywords
vaccine
diluent
bottle
dilution
injection
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Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN201610504307.4A
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Chinese (zh)
Inventor
罗清
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Guangdong San Diego Biotechnology Co Ltd
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Guangdong San Diego Biotechnology Co Ltd
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Priority to CN201610504307.4A priority Critical patent/CN105999287A/en
Publication of CN105999287A publication Critical patent/CN105999287A/en
Pending legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin

Abstract

The invention discloses a vaccine diluent and a preparation method thereof, and belongs to the technical field of vaccines. Each litre of vaccine diluent is prepared from the following components: 30 to 80 g of saccharose, 0.25 to 1 g of monopotassium phosphate, 0.5 to 1.5 g of dipotassium phosphate, 0.5 to 1.5 g of L-sodium glutamate, 5 to 30 g of enzymatic hydrolysis casein, 0.005 to 0.015 g of phenol red, and the balance of water for injection. The vaccine diluent disclosed by the invention is long in storage time and high in stability, and can be stored for 24 months or above. The vaccine diluent is reasonable in formula, has a suitable stabilizer to ensure that a liquid is not liable to change, and has rich nutrients to provide survival needs for a vaccine, so that the vaccine diluent has a very good protection effect on the vaccine; therefore, high activity of the vaccine is kept in the environment of the diluent, and the effect of the vaccine is ensured.

Description

A kind of vaccine diluent and preparation method thereof
Technical field
The invention belongs to technical field of vaccines, particularly to a kind of vaccine diluent and preparation method thereof.
Background technology
Marek is a kind of lymphoproliferative oncosis of chicken, it is characterized by peripheral nervous lymphoid cell infiltration and increase, causes limb (wing) to benumb, and gonad, iris, various internal organs, muscle and cutaneous tumor focus.Primary disease is a kind of worldwide disease, is currently three big mainly one of epidemic diseases (Marek, newcastle disease and infectious bursal disease) that harm poultry husbandry develops in a healthy way, causes the M & M that chicken group is higher.
Mareks disease vaccine is the first effective veterinary cancer vaccine in the world, plays a crucial role anti-Marek processed.Having two kinds of attenuated vaccine, a kind of is virus and the vaccine such as SB1 Seedling of Cell binding, 814 Seedlings, and preservation condition requires strict, needs Liquid nitrogen storage;Another kind is the de-cellifugal herpes turkey virus vaccine (HVT) of virus, can be with lyophilizing, and preservation is easier to, and uses extensively, but the infection mitigation weak effect to virulent Marek's disease virus (WMDV).
Summary of the invention
It is an object of the invention to the shortcoming overcoming prior art with not enough, it is provided that a kind of vaccine diluent.
Another object of the present invention is to provide the preparation method of described vaccine diluent.
The purpose of the present invention is achieved through the following technical solutions: a kind of vaccine diluent, containing following component: in each liter of vaccine diluent, contain: 30-80g sucrose, 0.25-1g potassium dihydrogen phosphate, 0.5-1.5g dipotassium hydrogen phosphate, 0.5-1.5g L-sodium, 5-30g enzyme hydrolysis casein, 0.005-0.015g are phenol red, and surplus is water for injection.
Preferably, in each liter of vaccine diluent, contain: 50g sucrose, 0.5g potassium dihydrogen phosphate, 1.25g dipotassium hydrogen phosphate, 0.8g L-sodium, 15g enzyme hydrolysis casein, 0.009g are phenol red, surplus is water for injection.
Described vaccine is preferably chicken Marek's disease live-vaccine.
The preparation method of described vaccine diluent, comprise the steps: to add in water for injection by 30-80g sucrose, 0.25-1g potassium dihydrogen phosphate, 0.5-1.5g dipotassium hydrogen phosphate, 0.5-1.5g L-sodium and 5-30g enzyme hydrolysis casein, one liter is injected water to after stirring and dissolving, add 0.005-0.015g phenol red, stirring also reflux cycle 15 minutes, filter, obtain vaccine diluent.
Described vaccine diluent can be applicable to vaccine dilution.
Described vaccine dilution includes that freeze dried vaccine dilution and liquid nitrogen vaccine dilute.
Described freeze dried vaccine dilution is adopted and is carried out with the following method:
A. open the little aluminium lid on vaccine bottle and the vinyl cover on diluent bottle, with cotton ball soaked in alcohol sterilization vaccine bottle and
Diluent bottle cap surface, treats that ethanol, after drying with aseptic 5 milliliters of syringes, punctures diluent bottle cap 2 ~ 3 milliliters of diluents of extraction, injects in vaccine bottle;
B. shake vaccine bottle, dissolves suspendible to vaccine, then draws back in syringe by suspendible vaccine liquid, in re-injection to diluent bottle;
C. from diluent bottle, again extract 2 ~ 3 milliliters of diluents out rinse vaccine bottle, in re-injection to diluent bottle, repetitive operation 1 ~ 2 time, by the vaccine mix homogeneously of dilution;
Connect transfusion tube joint and inoculation syringe, can use after suspension.Diluent must be stored in room temperature.
Described liquid nitrogen vaccine dilution is adopted and is carried out with the following method:
A) open the vinyl cover on diluent bottle, with cotton ball soaked in alcohol sterilization diluent bottle cap surface, treat ethanol natural drying;
B) from liquid nitrogen container, take out rapidly the vaccine ampulla that will use, be placed in jog in 27 DEG C of water, made the vaccine in ampulla thaw completely in 90 seconds;
C) after vaccine thaws completely, break lower ampoule valve protection cap, draw, with 5 milliliters of asepsis injectors of more than No. 12 syringe needles, the vaccine solution thawed, inject in diluent bottle through diluent bottle cap;
D) from diluent bottle, extract 2-3 milliliter solution out and rinse ampoule and ampoule cap, by its re-injection to diluent bottle, repetitive operation 1-2 time.The vaccine of dilution is shaken up.
The complete time is prepared to vaccine solution from taking out vaccine ampoule, should be less than 120 seconds.Connect transfusion tube joint and inoculation syringe, can use after suspension.Note: cervical region subcutaneous vaccination, 0.2 milliliter every part.Vaccine should be finished in 1 hour after dilution.
The present invention has such advantages as relative to prior art and effect:
(1) the vaccine diluent resting period of the present invention is long, good stability, it is possible to deposit more than 24 months.
(2) formula of the present invention is reasonable; change is less likely to occur liquid to have suitable stabilizer to ensure, has abundant nutrient substance can provide the survival demand of live vaccine, therefore has good protective effect to vaccine; vaccine is made to keep high activity under this diluent environment, it is ensured that the effect of vaccine.
Detailed description of the invention
Below in conjunction with embodiment, the present invention is described in further detail, but embodiments of the present invention are not limited to this.
Embodiment 1
40g sucrose, 1g potassium dihydrogen phosphate, 1g dipotassium hydrogen phosphate, 1g L-sodium and 10g enzyme hydrolysis casein are added in water for injection, injecting water to one liter after stirring and dissolving, 0.015g is phenol red in addition, stirring also reflux cycle 15 minutes, filter, obtain vaccine diluent.
Embodiment 2
60g sucrose, 0.25g potassium dihydrogen phosphate, 1.5g dipotassium hydrogen phosphate, 0.5g L-sodium and 20g enzyme hydrolysis casein are added in water for injection, injecting water to one liter after stirring and dissolving, 0.005g is phenol red in addition, stirring also reflux cycle 15 minutes, filter, obtain vaccine diluent.
Embodiment 3
50g sucrose, 0.5g potassium dihydrogen phosphate, 1.25g dipotassium hydrogen phosphate, 0.8g L-sodium and 15g enzyme hydrolysis casein are added in water for injection, injecting water to one liter after stirring and dissolving, 0.009g is phenol red in addition, stirring also reflux cycle 15 minutes, filter, obtain vaccine diluent.
Application Example 1
Freeze dried vaccine dilution is adopted and is carried out with the following method:
A. open the little aluminium lid on vaccine bottle and the vinyl cover on diluent bottle, with cotton ball soaked in alcohol sterilization vaccine bottle and
Diluent bottle cap surface, treats that ethanol, after drying with aseptic 5 milliliters of syringes, punctures diluent bottle cap 2 ~ 3 milliliters of diluents of extraction, injects in vaccine bottle;
B. shake vaccine bottle, dissolves suspendible to vaccine, then draws back in syringe by suspendible vaccine liquid, in re-injection to diluent bottle;
C. from diluent bottle, again extract 2 ~ 3 milliliters of diluents out rinse vaccine bottle, in re-injection to diluent bottle, repetitive operation 1 ~ 2 time, by the vaccine mix homogeneously of dilution;
Connect transfusion tube joint and inoculation syringe, can use after suspension;Diluent must be stored in room temperature.
Application Example 2
The dilution of liquid nitrogen vaccine is adopted and is carried out with the following method:
A) open the vinyl cover on diluent bottle, with cotton ball soaked in alcohol sterilization diluent bottle cap surface, treat ethanol natural drying;
B) from liquid nitrogen container, take out rapidly the vaccine ampulla that will use, be placed in jog in 27 DEG C of water, made the vaccine in ampulla thaw completely in 90 seconds;
C) after vaccine thaws completely, break lower ampoule valve protection cap, draw, with 5 milliliters of asepsis injectors of more than No. 12 syringe needles, the vaccine solution thawed, inject in diluent bottle through diluent bottle cap;
D) from diluent bottle, extract 2-3 milliliter solution out and rinse ampoule and ampoule cap, by its re-injection to diluent bottle, repetitive operation 1-2 time.The vaccine of dilution is shaken up.
The complete time is prepared to vaccine solution from taking out vaccine ampoule, should be less than 120 seconds.Connect transfusion tube joint and inoculation syringe, can use after suspension.Note: cervical region subcutaneous vaccination, 0.2 milliliter every part.Vaccine should be finished in 1 hour after dilution.
Above-described embodiment is the present invention preferably embodiment; but embodiments of the present invention are also not restricted to the described embodiments; the change made under other any spirit without departing from the present invention and principle, modify, substitute, combine, simplify; all should be the substitute mode of equivalence, within being included in protection scope of the present invention.

Claims (8)

1. a vaccine diluent, it is characterized in that: containing following component: in each liter of vaccine diluent, contain: 30-80g sucrose, 0.25-1g potassium dihydrogen phosphate, 0.5-1.5g dipotassium hydrogen phosphate, 0.5-1.5g L-sodium, 5-30g enzyme hydrolysis casein, 0.005-0.015g are phenol red, and surplus is water for injection.
Vaccine diluent the most according to claim 1, it is characterized in that: in each liter of vaccine diluent, contain: 50g sucrose, 0.5g potassium dihydrogen phosphate, 1.25g dipotassium hydrogen phosphate, 0.8g L-sodium, 15g enzyme hydrolysis casein, 0.009g are phenol red, surplus is water for injection.
Vaccine diluent the most according to claim 1, it is characterised in that: described vaccine is chicken Marek's disease live-vaccine.
4. the preparation method of the vaccine diluent described in any one of claims 1 to 3, it is characterized in that: comprise the steps: to add in water for injection by 30-80g sucrose, 0.25-1g potassium dihydrogen phosphate, 0.5-1.5g dipotassium hydrogen phosphate, 0.5-1.5g L-sodium and 5-30g enzyme hydrolysis casein, one liter is injected water to after stirring and dissolving, add 0.005-0.015g phenol red, stirring also reflux cycle 15 minutes, filter, obtain vaccine diluent.
5. the vaccine diluent described in any one of claims 1 to 3 is applied to vaccine dilution.
Vaccine diluent the most according to claim 5 is applied to vaccine dilution, it is characterised in that: described vaccine dilution includes that freeze dried vaccine dilution and liquid nitrogen vaccine dilute.
Vaccine diluent the most according to claim 6 is applied to vaccine dilution, it is characterised in that: described freeze dried vaccine dilution is adopted and is carried out with the following method:
A. open the little aluminium lid on vaccine bottle and the vinyl cover on diluent bottle, with cotton ball soaked in alcohol sterilization vaccine bottle and
Diluent bottle cap surface, treats that ethanol, after drying with aseptic 5 milliliters of syringes, punctures diluent bottle cap 2 ~ 3 milliliters of diluents of extraction, injects in vaccine bottle;
B. shake vaccine bottle, dissolves suspendible to vaccine, then draws back in syringe by suspendible vaccine liquid, in re-injection to diluent bottle;
C. from diluent bottle, again extract 2 ~ 3 milliliters of diluents out rinse vaccine bottle, in re-injection to diluent bottle, repetitive operation 1 ~ 2 time, by the vaccine mix homogeneously of dilution.
Vaccine diluent the most according to claim 6 is applied to vaccine dilution, it is characterised in that: described liquid nitrogen vaccine dilution is adopted and is carried out with the following method:
A) open the vinyl cover on diluent bottle, with cotton ball soaked in alcohol sterilization diluent bottle cap surface, treat ethanol natural drying;
B) from liquid nitrogen container, take out rapidly the vaccine ampulla that will use, be placed in jog in 27 DEG C of water, made the vaccine in ampulla thaw completely in 90 seconds;
C) after vaccine thaws completely, break lower ampoule valve protection cap, draw, with 5 milliliters of asepsis injectors of more than No. 12 syringe needles, the vaccine solution thawed, inject in diluent bottle through diluent bottle cap;
D) from diluent bottle, extract 2-3 milliliter solution out and rinse ampoule and ampoule cap, by its re-injection to diluent bottle, repetitive operation 1-2 time, the vaccine of dilution is shaken up.
CN201610504307.4A 2016-07-01 2016-07-01 Vaccine diluent and preparation method thereof Pending CN105999287A (en)

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Application Number Priority Date Filing Date Title
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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3783098A (en) * 1971-08-10 1974-01-01 Cornell Res Foundation Inc Highly potent,viable and stable cellfree virus preparations from cells infected with cell-associated viruses and method for obtaining the same
US3915794A (en) * 1973-02-09 1975-10-28 Rit Rech Ind Therapeut Stabilizing compositions for cell-free viruses and cell-free virus preparations containing them
CN103316335A (en) * 2013-05-31 2013-09-25 北京科兴生物制品有限公司 Poliovirus vaccine for oral administration

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3783098A (en) * 1971-08-10 1974-01-01 Cornell Res Foundation Inc Highly potent,viable and stable cellfree virus preparations from cells infected with cell-associated viruses and method for obtaining the same
US3915794A (en) * 1973-02-09 1975-10-28 Rit Rech Ind Therapeut Stabilizing compositions for cell-free viruses and cell-free virus preparations containing them
CN103316335A (en) * 2013-05-31 2013-09-25 北京科兴生物制品有限公司 Poliovirus vaccine for oral administration

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
张传明等: ""稀释液对鸡马立克氏病i+iii型双价冷冻疫苗病毒存活率的影响"", 《研究动态》 *
王明俊等: "《禽畜用药指南 第二版》", 30 September 1998, 中国农业出版社 *

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Application publication date: 20161012

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