CN108917292A - A kind of drug sensitive test card drying means - Google Patents
A kind of drug sensitive test card drying means Download PDFInfo
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- CN108917292A CN108917292A CN201810470281.5A CN201810470281A CN108917292A CN 108917292 A CN108917292 A CN 108917292A CN 201810470281 A CN201810470281 A CN 201810470281A CN 108917292 A CN108917292 A CN 108917292A
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- test card
- drying means
- drying
- drug sensitive
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- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F26—DRYING
- F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
- F26B1/00—Preliminary treatment of solid materials or objects to facilitate drying, e.g. mixing or backmixing the materials to be dried with predominantly dry solids
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F26—DRYING
- F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
- F26B3/00—Drying solid materials or objects by processes involving the application of heat
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F26—DRYING
- F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
- F26B5/00—Drying solid materials or objects by processes not involving the application of heat
- F26B5/04—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum
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- Engineering & Computer Science (AREA)
- Mechanical Engineering (AREA)
- General Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- Microbiology (AREA)
- Health & Medical Sciences (AREA)
- Molecular Biology (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention discloses a kind of drug sensitive test card drying means.This approach includes the following steps：(1) the susceptibility solution that joined surfactant is added in blank test card hole for medicine preparation and sample-adding；(2) product pre-cooling to be dried；(3) preliminarily dried：Drying equipment in closed step (2), vacuumizes, and while vacuumizing, is filled with nitrogen, maintains vacuum degree, while heating to product, keeps the temperature；(4) vacuum degree is evacuated to 100pa and is dried hereinafter, raising the temperature to 30 DEG C or more simultaneously, moisture is made to be reduced to 1% or less by parsing-desiccation.This method joined surfactant during medicine preparation, nitrogen is filled in drying process, guarantee that whole process liquid internal will not generate violent movement, to solve the problems, such as the stability of drug in drying process and jump hole, drug is effectively adhered in test hole after the completion of guaranteeing drying simultaneously, solves the problems, such as the jump hole in transportational process.
Description
Technical field
The invention belongs to field of medicaments, and in particular to a kind of drug sensitive test card drying means.
Background technique
Drug sensitive experiment card is that one kind of the antibiotics susceptibility test for microorganism (including bacterium, fungi, mycobacterium) is examined in vitro
Disconnected reagent carries out antibiotics susceptibility test using broth dilution method, and the product for carrying out commercial sales in the market in China includes method
The ATB series drug sensitive test card of Biomerieux SA of state, the TDR series of Changsha people from world Biotechnology Co., Ltd are raw
Quick test card of chemical drug etc..In order to guarantee stability of drug during production process and storage in biochemical susceptibility test card product
And product convenient transportation, the preparation of the product are generally divided into following steps：Drug weighs, drug dissolution and allotment, drug are molten
Liquid is added to blank test card, drying, packaging.
Wherein, drying process is the core procedure in production process, is the stability for guaranteeing medicine production process, storage
Deposit stability, drug does not jump the key in hole in drying process and in transportational process.Currently, common drying process includes that freeze-drying is dry
It is dry, constant pressure and dry, vacuum drying etc..
Freeze drying process is the drying process under a kind of low temperature, and the principle of drying is the distillation of solid.Lyophilization
Firstly the need of product temperature is chilled to eutectic point hereinafter, then vacuumizing makes liquid sublimation, to reach the mesh of dehydration and drying
, its main feature is that：Many hot substances will not occur to be denaturalized or inactivate；Some volatilizations when dry at low temperature, in substance
Property component damages very little；In freeze-drying process, the growth of microorganism and the effect of enzyme can not be carried out, therefore be able to maintain original property
Shape；Due to being dried in the state of freezing, volume is almost unchanged, maintains original structure, will not be concentrated
Phenomenon；Since moisture exists in the form of ice crystal after pre-freeze in material, originally inorganic salts soluble in water dissolve substance
It is uniformly distributed among material.When distillation, dissolution substance soluble in water is just precipitated, avoid in general drying means because
Material internal moisture is to inorganic salts entrained by surface migration the phenomenon that surface is precipitated and causes Surface hardened layer；Since drying exists
It is carried out under vacuum, oxygen is few, therefore some oxidizable substances are protected；It can exclude 95%~99% or more water
Point, product long-term preservation is without mutagens matter after enabling drying.The Chinese invention patent of CN105087752A discloses a kind of susceptibility
The preparation method of kit, main process are freezing, distillation, parsing, which is a kind of lyophilized technique of obvious characteristic.For
It solves the problems, such as after freeze-drying that drug is loose to be easy to jump hole during transportation, examination is added in nutriment and antibiotic simultaneously
It is dried in verifying, advantageously reduces jump porosity, but its essence is still freeze-drying, do not tried from the basic Drug absorbability that solves
The problems in verify；And the nutriment since the easy moisture absorptions such as MH meat soup are added, cause product to suck water during the packaging process
Divide to influence the stability of product during storage.
Constant pressure and dry is mainly to be volatilized using liquid surface in the drying for being lower than product melting temperature, reach drying purpose.
Its main feature is that：Low energy consumption, and equipment requirement is not high, easy to operate.The Chinese invention patent of CN101210770A discloses a kind of normal
Normal pressure and temperature is dry, has the following disadvantages：(1) drying process maintains room temperature or higher temperature, is unfavorable for being easy decomposition
Drug drying, such as beta-lactam antibiotic clavulanic acid, Imipenem；(2) drying process exposes in air, no
Conducive to drug easy to oxidize, it is thus possible to need to add antioxidant etc..
Vacuum drying mainly utilizes the low-boiling feature of liquid low pressure, on the basis of normal temperature and pressure is dry, vacuumizes
Air pressure is reduced, it is faster dry to achieve the effect that.Its main feature is that：Drying time is most short, easy to operate；Due to being vacuum ring
Border, oxygen content is low, thus plays a protective role for oxidizable product；The disadvantage is that：Easily bubbling in the drying process,
Drug is caused to jump hole.The patent of invention of CN1732257A discloses a kind of drying process for forming high viscosity liquid, belongs to vacuum
Dry range, the instrument connection unit that suitable carrier is relatively large in diameter, the test plate unit for being not suitable for lower diameter is dry, easily makes
At bubbling phenomenon, occur jumping hole.This bubbling phenomenon is caused not due to liquid boiling, but since liquid internal dissolves naturally
Gas is washed out in low pressure, forms bubble.Simultaneously when test cell diameter is smaller, capillarity is more obvious, in addition low pressure is made
It is more prominent at the widened liquid phenomenon of lifting of bubble, it easily causes to jump hole, and the main purpose of the patent of invention is to form height
Viscous liquid, for drug sensitive test card, the presence of liquid is the validity period that can seriously affect test card.
Summary of the invention
The purpose of the invention is to overcome the shortcomings of above-mentioned background technique, it is intended to be dried to obtain one kind by low-temp low-pressure
The amorphous state of drug, solve drug sensitive test be stuck in technique it is dry in drug it is vulnerable, it is oxidizable, easily jump hole, it is dry after product
It is unfavorable for the problem of transporting for powder or chip solid and solves the problems, such as that energy consumption for drying is high, drying time is long.
To achieve the purpose of the present invention, the present invention provides a kind of drug sensitive test card drying means, this method includes following
Step：
(1) blank examination is added in the bio-chemical solution that joined surfactant or susceptibility solution by medicine preparation and sample-adding
It tests in card hole；
(2) product pre-cooling to be dried, the test card that sample-adding is completed in step (1) is put into drying equipment and is pre-chilled；
(3) preliminarily dried, the drying equipment in closed step (2), vacuumizes, while vacuumizing, is filled with nitrogen, ties up
Vacuum degree is held, while product is heated, is kept the temperature；
(4) vacuum degree is evacuated to 100pa and is dried hereinafter, raising the temperature to 30 DEG C or more simultaneously, made by parsing-desiccation
Moisture is reduced to 1% to complete hereinafter, drying, packaging test card.
Preferably, the HLB value of nonionic surface active agent described in step (1) of the present invention is 3.0~20.0, such as
14.0~17.0.
In the present invention, nonionic surface active agent described in step (1) is 0.001-0.1% polyalcohols surface-active
Agent or polyethylene glycol type surfactant, as span 20, span 40, sorbester p18, sorbester p17, polysorbate 20, polysorbate 40,
Polysorbate 60, polyoxyethylene sorbitan monoleate, polysorbate 85, Myrj45, Myrj49, Myrj51, Myrj52, Myrj53, Brij30 and
Any surfactant in Brij35, such as 0.01% span 20.
Preferably, in the present invention, the sample-adding amount of sample-adding described in step (1) can be the 10 μ l of μ l~200, such as 25 μ l~
50μl。
Preferably, in the present invention, the precooling temperature of pre-cooling described in step (2) can be 2-8 DEG C, such as 2-5 DEG C.
In the present invention, vacuumizing described in step (3) can be vacuum degree and is evacuated to 2000pa.
In the present invention, maintenance vacuum degree described in step (3), which can be, maintains 800-2300pa for vacuum degree.
In the present invention, step heats product described in (3), and heat preservation can be heating, and temperature is controlled in 4-12
Within the scope of DEG C.
In the present invention, step vacuumizes described in (3), while vacuumizing, is filled with nitrogen, maintains vacuum degree, simultaneously
Product is heated, the specific procedure of heat preservation can be as follows：
In the present invention, step vacuumizes described in (3), while vacuumizing, is filled with nitrogen, maintains vacuum degree, simultaneously
Product is heated, the specific procedure of heat preservation can be as follows：
In the present invention, step vacuumizes described in (3), while vacuumizing, is filled with nitrogen, maintains vacuum degree, simultaneously
Product is heated, the specific procedure of heat preservation can be as follows：
In the present invention, parsing-desiccation temperature described in step (4) is no more than 40 DEG C, and the time is no more than 1h.
In the present invention, packaging test card described in step (4) is that test card is packaged in the aluminium film that air penetrability is low and is protected from light
Bag.
Compared with prior art, the invention has the advantages that：
1, nonionic surface active agent is added, nonionic surface active agent is simultaneously not involved in chemical reaction, not to micro- life
Object antibiotics susceptibility test result impacts, and is mainly used for reducing surface tension of liquid, drops low-surface-energy, be a kind of physical action,
It avoids forming bubbling in drying process, causes to jump hole, while surface can reduce, and accelerate rate of drying, reduce energy consumption；
2, low temperature precooling treatment, precooling temperature is 2~8 DEG C, to guarantee the stability of drug；
3, inflated with nitrogen controls starvation convenient for air pressure range, avoids oxidizable drug from decomposing, while disturbing medication level
Air-flow increases evaporation rate, reaches quick-drying purpose；
4, low pressure reduces the boiling point of liquid, and sequencing temperature-control pressure-control can be taken to be dried, and does not have to for liquid being frozen into solid
State reduces energy consumption, while can reduce oxygen content to improve rate of drying, cooperates inflated with nitrogen, and oxidizable drug is avoided to decompose；
5, realize that place is the drying equipment of a kind of closed controllable temperature, pressure control, it is that freeze dryer (but is adopted that the present invention, which uses,
Drying principles not lyophilized), guarantee that liquid is in liquid condition always in the drying process, breaks stress structure, entire liquid
Body is carried out in the form of surface evaporation, is filled with nitrogen, maintains metastable air pressure, guarantees that whole process liquid internal will not produce
Raw violent movement has good adhesiveness so that excipient/drug be made to form amorphous state after the drying in hole, from
And solve the problems, such as the jump hole in transportational process.
Detailed description of the invention
Fig. 1 is drying means flow chart of the invention；
Specific embodiment
In order to make the objectives, technical solutions, and advantages of the present invention clearer, with reference to the accompanying drawings and embodiments, right
The present invention is further elaborated.Additional aspect and advantage of the invention will be set forth in part in the description, part
It will become apparent from the description below, or practice through the invention is recognized.It is only used to solve it should be appreciated that being described below
The present invention is released, is not intended to limit the present invention.
Term "comprising" used herein, " comprising ", " having ", " containing " or its any other deformation, it is intended that covering
Non-exclusionism includes.For example, composition, step, method, product or device comprising listed elements are not necessarily limited to those and want
Element, but may include not expressly listed other elements or such composition, step, method, product or device it is intrinsic
Element.
Equivalent, concentration or other values or parameter are excellent with range, preferred scope or a series of upper limit preferred values and lower limit
When the Range Representation that choosing value limits, this should be understood as specifically disclosing by any range limit or preferred value and any range
Any pairing of lower limit or preferred value is formed by all ranges, regardless of whether the range separately discloses.For example, when open
When range " 1 to 5 ", described range should be interpreted as including range " 1 to 4 ", " 1 to 3 ", " 1 to 2 ", " 1 to 2 and 4 to
5 ", " 1 to 3 and 5 " etc..When numberical range is described herein, unless otherwise stated, otherwise the range is intended to include its end
Value and all integers and score in the range.
Moreover, technical characteristic involved in each embodiment of the present invention as long as they do not conflict with each other can
To be combined with each other.
Embodiment 1
1. working solution is prepared：The antibiotic solution or biochemical working solution of various concentration needed for configuration and type, are matching
The nonionic surface active agent that HLB value is 3.0~20.0 is added during setting；
2. being loaded：Blank test card is added in the solution for completing preparation, every hole additional amount is 25 μ l；
3. being pre-chilled：The test card for completing sample-adding is put into dry separator for container, chamber door, partition refrigeration, by product temperature are shut
Degree is down to 2-4 DEG C；
4. preliminarily dried：Vacuum pump and nitrogen permeation switch are opened, and program parameter is set according to following procedure.
5. parsing-desiccation closes nitrogen and controls solenoid valve, opens vacuum pump, vacuum is evacuated to 100Pa hereinafter, maintaining 1h.
6. packing：Using aluminium foil bag vacuum packing product.
7. entire drying time is no longer than 14h, wherein initial drying time is no longer than 10h.
Embodiment 2
1. working solution is prepared：The antibiotic solution or biochemical working solution of various concentration needed for configuration and type, are matching
The nonionic surface active agent that HLB value is 3.0~20.0 is added during setting；
2. being loaded：Blank test card is added in the solution for completing preparation, every hole additional amount is 25 μ l；
3. being pre-chilled：The test card for completing sample-adding is put into dry separator for container, chamber door, partition refrigeration, by product temperature are shut
Degree is down to 2-4 DEG C；
4. preliminarily dried：Vacuum pump and nitrogen permeation switch are opened, and program parameter is set according to following procedure.
5. parsing-desiccation closes nitrogen and controls solenoid valve, opens vacuum pump, vacuum is evacuated to 100Pa hereinafter, maintaining 1h.
6. packing：Using aluminium foil bag vacuum packing product.
7. entire drying time is no longer than 14h, wherein initial drying time is no longer than 10h.
Embodiment 3
1. working solution is prepared：The antibiotic solution or biochemical working solution of various concentration needed for configuration and type, are matching
The nonionic surface active agent that HLB value is 3.0~20.0 is added during setting；
2. being loaded：Blank test card is added in the solution for completing preparation, every hole additional amount is 25 μ l；
3. being pre-chilled：The test card for completing sample-adding is put into dry separator for container, chamber door, partition refrigeration, by product temperature are shut
Degree is down to 2-4 DEG C；
4. preliminarily dried：Vacuum pump and nitrogen permeation switch are opened, and program parameter is set according to following procedure.
5. parsing-desiccation closes nitrogen and controls solenoid valve, opens vacuum pump, vacuum is evacuated to 100Pa hereinafter, maintaining 1h.
6. packing：Using aluminium foil bag vacuum packing product.
7. entire drying time is no longer than 14h, wherein initial drying time is no longer than 10h.
Embodiment 4
Addition surfactant and the jump porosity contrastive test for not adding surfactant：
1. working solution is prepared：Purified water and 0.01% span 20 are added respectively, configure a series of the mould through the ages of various concentrations
Plain (concentration is respectively 0.12/0.25/0.5/1/2/4/8/16 μ g/ml), (concentration is respectively 0.03/0.06/0.12/ to penicillin
0.25/0.5/1/2/4 μ g/ml), gentamicin (concentration is respectively 0.12/0.25/0.5/1/2/4/8/16 μ g/ml), cephalo
His pyridine (concentration is respectively 0.06/0.12/0.25/0.5/1/2/4/8 μ g/ml) solution, no less than 100ml；
2. being loaded：Above-mentioned solution is added in 96 hole blank test cards according to drug concentration from down to high sequence, every hole
Additional amount is 25 μ l, and every kind of every kind of drug formula is loaded 20 holes respectively；
2. the test card for completing sample-adding is put into dry separator for container, according in case study on implementation 1, embodiment 2 or embodiment 3
Method be dried and pack；
3. using strain golden color staphylococcus A TCC29213, the enterococcus faecalis ATCC29212 of cell age 16-24h to ten thousand
Ancient mycin, penicillin test card are tested；It is false single using the bacterial strain escherichia coli ATCC25922 of cell age 16-24h, verdigris
Born of the same parents bacterium ATCC27853 tests gentamicin, cefotaxime test card；
4. observation is as a result, statistics minimal inhibitory concentration MIC jumps hole situation, calculating jumps porosity and (jumps porosity=jump hole count/test
Hole count)；
5. test result see the table below, (value recorded in table is by the method in case study on implementation 1, embodiment 2 or embodiment 3
The mean value of gained test card, relative standard deviation is less than 2%)
Embodiment 5
The test of minimal inhibitory concentration MIC accuracy and accelerated stability test after labile drugs are dry：
1. working solution is prepared：The span 20 of addition 0.01%, configuring the penicillin of various concentrations a series of, (concentration is respectively
0.03/0.06/0.12/0.25/0.5/1/2/4 μ g/ml), amoxicillin with clavulanic acid (0.25/0.12,0.5/0.25,1/
0.5,2/1,4/2,8/4,16/8,32/16 μ g/ml), Cefazolin (0.25/0.5/1/2/4/8/16/32 μ g/ml), cephalo furan
(concentration is respectively 0.06/0.12/0.25/0.5/1/2/4/8 μ to pungent (0.5/1/2/4/8/16/32/64 μ g/ml) cefotaxime
G/ml), (concentration is respectively for Cefepime (concentration is respectively 0.06/0.12/0.25/0.5/1/2/4/8 μ g/ml), Meropenem
0.12/0.25/0.5/1/2/4/8/16 μ g/ml), (concentration is respectively 0.06/0.12/0.25/0.5/1/2/4/8 to Imipenem
μ g/ml) solution, no less than 100ml；
2. being loaded：96 hole blank test cards, every hole is added from down to high sequence according to drug concentration in above-mentioned solution
Additional amount is 25 μ l, and every kind of drug is loaded 20 holes respectively；
3. the test card for completing sample-adding is put into dry separator for container, be dried according to the method in case study on implementation 1 and
Packaging；
4. using strain golden color staphylococcus A TCC29213, the enterococcus faecalis ATCC2921, large intestine of cell age 16-24h
Angstrom uncommon bacterium ATCC25922, pseudomonas aeruginosa ATCC27853, escherichia coli ATCC35218 are sticked into dry test is completed
Row test, specific test result are detailed in following table；All test results meet bacterial strain quality control standard requirement.
5. under conditions of test is placed in 37 DEG C, taking out and being tested after 2/4/6/8/10/12 week, investigate not
Whether the stability with drug meets product storage request, and test result is as follows：
As it will be easily appreciated by one skilled in the art that the foregoing is merely illustrative of the preferred embodiments of the present invention, not to
The limitation present invention, any modifications, equivalent substitutions and improvements made within the spirit and principles of the present invention should all include
Within protection scope of the present invention.
Claims (10)
1. a kind of drug sensitive test card drying means, which is characterized in that this approach includes the following steps：
(1) the susceptibility solution that joined nonionic surface active agent is added in blank test card hole for medicine preparation and sample-adding；
(2) product pre-cooling to be dried, the test card that sample-adding is completed in step (1) is put into drying equipment and is pre-chilled；
(3) preliminarily dried, the drying equipment in closed step (2), vacuumizes, and while vacuumizing, is filled with nitrogen, remains true
Reciprocal of duty cycle, while product is heated, it keeps the temperature；
(4) vacuum degree is evacuated to 100pa and is dried hereinafter, raising the temperature to 30 DEG C or more simultaneously, makes moisture by parsing-desiccation
It is reduced to 1% to complete hereinafter, drying, packaging test card.
2. drug sensitive test card drying means according to claim 1, which is characterized in that the nonionic surface active agent
HLB value be 3.0~20.0, such as 14.0~18.0.
3. drug sensitive test card drying means according to claim 1, which is characterized in that the nonionic surface active agent
0.001-0.1% polyol surfactant or polyethylene glycol type surfactant, as span 20, span 40, sorbester p18,
Sorbester p17, polysorbate 20, polysorbate 40, polysorbate 60, polyoxyethylene sorbitan monoleate, polysorbate 85, Myrj45, Myrj49,
Any surfactant in Myrj51, Myrj52, Myrj53, Brij30 and Brij35, such as 0.01% span 20.
4. identification and susceptibility test card drying means according to claim 1, which is characterized in that the sample-adding amount of the sample-adding can
Think the 10 μ l of μ l~200, such as 25 μ of μ l~50 l.
5. drug sensitive test card drying means according to claim 1, which is characterized in that pre-cooling described in step (2) it is pre-
Cold temperature can be 2-8 DEG C, such as 2-5 DEG C.
6. drug sensitive test card drying means according to claim 1, which is characterized in that vacuumizing described in step (3) can
To be that vacuum degree is evacuated to 2000pa.
7. drug sensitive test card drying means according to claim 1, which is characterized in that step maintains vacuum described in (3)
Degree, which can be, maintains 800-2300pa for vacuum degree.
8. drug sensitive test card drying means according to claim 1, which is characterized in that described in step (3) to product into
Row heating, heat preservation can be heating, by temperature control within the scope of 4-12 DEG C.
9. drug sensitive test card drying means according to claim 1, which is characterized in that step vacuumizes described in (3),
While vacuumizing, it is filled with nitrogen, maintains vacuum degree, while heating to product, the specific procedure of heat preservation is as follows：
Or it is as follows：
Or it is as follows：
10. drug sensitive test card drying means according to claim 1, which is characterized in that parsing-desiccation described in step (4)
Temperature is no more than 40 DEG C, and the time is no more than 1h, it is preferred that packaging test card described in step (4) is to be packaged in test card
Gas rate is low and the aluminum foil bag that is protected from light.
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|---|---|---|---|
| CN201810470281.5A CN108917292B (en) | 2018-05-16 | 2018-05-16 | Method for drying drug sensitivity test card |
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|---|---|---|---|
| CN201810470281.5A CN108917292B (en) | 2018-05-16 | 2018-05-16 | Method for drying drug sensitivity test card |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN110373447A (en) * | 2019-07-25 | 2019-10-25 | 长沙市第三医院 | A kind of multidrug resistance Gram-negative bacteria Combination susceptibility testing card and preparation method |
| CN114477706A (en) * | 2022-01-25 | 2022-05-13 | 青岛尚禹环保设备科技有限公司 | Flash evaporation mechanical filter pressing coupling vacuum sludge drying system and method |
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| JPH07294118A (en) * | 1994-04-22 | 1995-11-10 | Nippon F D Kk | Freezing/drying method, and vacuum heating container for freezing/drying apparatus |
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| Publication number | Publication date |
|---|---|
| CN108917292B (en) | 2020-08-11 |
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