CN109512781A - A kind of fluconazole injection production technology - Google Patents
A kind of fluconazole injection production technology Download PDFInfo
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- CN109512781A CN109512781A CN201811609130.XA CN201811609130A CN109512781A CN 109512781 A CN109512781 A CN 109512781A CN 201811609130 A CN201811609130 A CN 201811609130A CN 109512781 A CN109512781 A CN 109512781A
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- tank
- fluconazole
- injection
- preparing tank
- water
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Classifications
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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
-
- 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
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4196—1,2,4-Triazoles
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/10—Antimycotics
Abstract
The present invention provides a kind of fluconazole injection production technologies to have specifically included Fluconazole dissolution by forming with liquid, filling, sterilization process；It is added in dense preparing tank and is mixed with water for injection；Stirring and adsorbing after addition active carbon；Decarburization；It is directed into dilute preparing tank and is mixed after adding to the full amount of water for injection, filtered；The filling and processes such as sterilizing, finally obtain injection.Fluconazole dissolution of the invention is more preferable, more evenly using the composition in medical fluid.More effectively heat source substance is avoided to enter in finished product.The adsorption time for reducing active carbon, drug content is relatively low caused by preventing Fluconazole main ingredient to be adsorbed filtering.
Description
Technical field
The present invention relates to a kind of medical fluconazole injection production technologies.
Background technique
Fluconazole injection indication is candidiasis, including treatment pars oralis pharyngis and esophageal candidiasis, is sent out.Mainly
Composition is Fluconazole, and water for injection is sodium chloride.
Existing fluconazole injection preparation process is as follows:
1, it weighs in Fluconazole and sodium chloride investment dense preparing tank by recipe quantity, with the water for injection of prescription full dose 50%, adds
Thermal agitation is uniformly dissolved, and 0.2% (W/V) active carbon is added, stirs it, is kept the temperature (about 80 DEG C) and is adsorbed 10 minutes,
Pressure filtration decarburization while hot, in filling, obtains clear solution to dilute.
2, recipe quantity is injected water in dilute preparing tank, is stirred evenly.PH, content are surveyed in sampling.After qualification through 0.45um,
The miillpore filter refined filtration of 0.22um, is sub-packed in soft bag, sterilizes 30 minutes at 115 DEG C, lets cool inspection clarity, packs, full inspection
It is finished product after qualification.
In prior art, the finished product that finally obtains there are the problem of are as follows: Fluconazole drug content is relatively low, throws by 100%
Material, and finished product content declines about 4 percentage points 96.5% or so.
Above-mentioned phenomenon is analyzed, predominantly product affects final product quality in activated carbon adsorption overlong time.
Meanwhile in existing preparation process, in order to which preferably Fluconazole is dissolved in water for injection, need dissolving
Accelerate stirring in the process, but existing agitating mode is generally blade stirring, and a blade is protruded into tank body, passes through blade
Pot liquid is stirred, or by reflux pump, the liquid in tank is pumped up into reflux repeatedly.
Moreover, being also required to carry out blade stirring or return when carried out in dense preparing tank and dilute preparing tank with liquid, activated carbon adsorption
Stream stirring.
By above-mentioned blade stirring or return stirring two ways, it is required to be placed in tank body using another equipment,
And make mechanical movement, in mechanical movement, due to mechanical abrasion, it can generate and largely fall bits, fall bits and be mixed into medical fluid,
It will form new heat source substance, heat source substance is the underproof factor of injection, and heat source substance can cause injection to be injected into
Uncomfortable reaction is generated in patient body.Especially in dilute preparing tank, due to having had been subjected to activated carbon adsorption, new means will not be taken again
Heat source substance is adsorbed, therefore the bits that fall of the generation in dilute preparing tank will be directly by canned into finished product.
Therefore, it is necessary to study new medical fluconazole injection production technologies.
Summary of the invention
To solve the above-mentioned problems, the present invention provides a kind of fluconazole injection production technology, it ensure that fluorine in finished product
Health azoles content, more effectively avoids heat source substance from being mixed into finished product.
A kind of fluconazole injection production technology provided by the invention, by being formed with liquid, filling, sterilization process, specifically:
(1), water for injection 76%-79% is added in dense preparing tank, and dense preparing tank is added after Fluconazole is dissolved and mixes shape
At medical fluid, fluid temperature is controlled at 77-80 DEG C.
(3), it stirs, is adsorbed after active carbon being added into dense preparing tank.
(5), decarburization.
(6), it is directed into dilute preparing tank and is mixed after adding to the full amount of water for injection, filter, obtain injection.
(7), filling and sterilize, obtain finished product.
A kind of fluconazole injection production technology as described above, further explains and is, described to dissolve Fluconazole,
Method particularly includes: Fluconazole raw material and water for injection 15L are added in dissolving tank and are sealed dissolving tank, will be extracted in dissolving tank
Vacuum is to -150Pa, 2-3 minute in sonic oscillation dissolving tank, until Fluconazole imports dense preparing tank after all dissolving, and will dissolve
After extracting vacuum -100Pa to -1000pa in tank, sonic oscillation cleans dissolving tank, and cleaning solution imports dense preparing tank.
A kind of fluconazole injection production technology as described above, further explains and is, it is described into dense preparing tank plus
It stirs, is adsorbed after entering active carbon, specifically, the ratio of 0.2g active carbon is added into dense preparing tank in every 1000 milliliters of medical fluids
Active carbon is added, vacuum will be extracted in dense preparing tank to -59KPa to -53KPa, and using 80-85 DEG C to concentrated compounding tank body bottom-heated
Make to generate convection current and boiling in hermetically sealed can, is stirred and adsorbs 13-16 minutes by convection current and boiling.
A kind of fluconazole injection production technology as described above, further explaining is that the decarburization will be specifically, will
Medical fluid precipitates 20 minutes, and 55-65 DEG C is cooled in precipitation process；Supernatant after precipitating is quickly put into Clear liquid tank, it will
Bottom liquid after precipitating is slowly filtered by pressurization to Clear liquid tank；Dilute preparing tank is directed into after liquid filtering decarburization in Clear liquid tank liquid.
A kind of fluconazole injection production technology as described above, further explaining is that described injects water to
It is mixed after full dose, specifically: it adds to the full amount of water for injection, vacuum will be extracted in dilute preparing tank to -76KPa to -85KPa, and utilize
60-70 DEG C, to dilute preparing tank bottom-heated, makes to generate convection current and boiling in dilute preparing tank, mixes object in tank, adjusts after 6-14 minutes
45 DEG C of fluid temperature, and being filled with pure air keeps dilute preparing tank interior and ambient atmosphere balance, stops convection current and boils.
A kind of fluconazole injection production technology as described above, further explaining is the sterilizing specifically: will
Injection after filling carries out water-bath sterilization together with package body, and 121 DEG C of water-bath sterilization temperature, time 9-10 minute.
The utility model has the advantages that
Fluconazole dissolution of the invention is more preferable, more evenly using the composition in medical fluid.
Due to having used on-bladed, the stirring without mechanical pump progress, mixed process, the present invention more effectively avoids heat
Source substance enters in finished product.
Since the present invention is production process is effectively prevented from stirring, mixed process is mixed into heat source substance, in medical fluid
Heat source substance total amount is less, therefore can reduce the adsorption time of active carbon, after the adsorption time for reducing active carbon, prevents fluorine health
Drug content is relatively low caused by azoles main ingredient is adsorbed filtering.
Specific embodiment
Fluconazole course of dissolution of the invention are as follows:
Before Fluconazole dissolution, the water for injection of recipe quantity 76-79% is first added in dense preparing tank.
Then start to dissolve Fluconazole: Fluconazole needed for formula ratio and small part water for injection are added in dissolving tank
And dissolving tank is sealed, the water for injection 120L being added in dissolving tank adds injection depending on dissolving tank size as far as possible
Water, in order to more good dissolving.Vacuum extremely -150Pa will be extracted in dissolving tank, after extracting vacuum, in sonic oscillation dissolving tank extremely
Fluconazole all after dissolution, is filled with clean gas air to atmospheric pressure, and Fluconazole lysate is imported dense preparing tank by opening dissolving tank, this
When dissolving tank in there are also remaining lysate, primary cleaning dissolving tank is carried out using water for injection, in the process of cleaning, using super
Sound oscillation, available better cleaning effect.Cleaning solution is equally imported into dense preparing tank.
Cleaning dissolving tank: being added water for injection into dissolving tank again, and vacuum will be extracted in dissolving tank to -100Pa, surpasses
Dissolving tank is cleaned in sound oscillation, and clean gas air is filled with after cleaning and is balanced to atmospheric pressure, dissolving tank is opened, cleaning solution is imported concentrated compounding
Tank.It is repeated once cleaning dissolving tank in this way again.
Fluconazole is subjected to more effective dissolving step, Fluconazole content in medical fluid can be made more evenly.If directly
It is added in dense preparing tank, the dense preparing tank in common process, but still can not be effectively although the stirring with some strength
Dissolution is completed, or makes Fluconazole content in medical fluid more evenly.Dense preparing tank is not equipped with stirring blade in this technique, so must
Article must will be not readily dissolved before entering dense preparing tank sufficiently to dissolve.
Sonic oscillation is carried out in small size vacuum environment, and dissolution is effectively performed.The volume of dissolving tank is less than 200 liters, even
It is connected to ultrasonator.
Vacuum in extracting centainly in dissolving tank, expands the molecular gap of injection, facilitates between molecule to dissolve
Therefore Fluconazole molecule of coming in the case where not improving equipment performance, vacuumizing cost, can improve vacuum degree as far as possible, with
Just dissolution is utilized.In addition, having certain bubble in water for injection, after extracting vacuum, part Bubble can be conducive to
Sonic oscillation can generate two kinds of holes in sonic oscillation water for injection.It is formed one is the gas vaporization in water for injection
Bubble hole；One is the true property holes that the steam of water for injection evaporation is formed.It is small in size due to bubble hole,
The shock wave generated when rupture is also weaker.And the true property hole of steam generation shock wave for generating in rupture be eager to excel 10 times with
On.The gas excluded in these waters for injection that can be deaerated using vacuum environment is just conducive to generate true property hole.And using very
Property hole powerful shock wave crush Fluconazole.
Cleaning dissolving tank, available better cleaning effect are carried out using ultrasonic wave.It completes, needs clear in dissolution work
Dissolving tank is washed, therefore uses and cleans dissolving tank twice under vacuum state.And cleaning solution is imported into dense preparing tank.
After first dissolved Fluconazole, water for injection being mixed well in dense preparing tank, add sodium chloride, then by every
Active carbon is added into dense preparing tank for the ratio that 0.2g active carbons are added in 1000 milliliters of medical fluids, will be extracted in dense preparing tank vacuum to-
59KPa to -53KPa, and concentrated compounding tank body bottom-heated is made to generate convection current and boiling in hermetically sealed can, the temperature of heating is dense to cause
It is generated subject to boiling in distribution tank, here when vacuum pressure is -59KPa to -53KPa in dense preparing tank, heating temperature 80-85
DEG C, that is, it can produce boiling effect, to dense preparing tank bottom-heated using heating outside tank body, pass through infrared heating, electromagnetic heating
Etc. modes, select electromagnetic heating here, if dense preparing tank carry heating device can also.Since the main ingredient in dense preparing tank is still
Water, therefore, when vacuum is taken away in dense preparing tank, internal pressure is less than atmospheric pressure, takes -59KPa to -53KPa here, preferably -
59KPa, according to water boiling point and pressure dependence, in -59KPa, the liquid in dense preparing tank can reach boiling point at 77 DEG C, therefore,
Fluid temperature is controlled at 77-80 DEG C；Concentrated compounding pot bottom carries out being heated to above 80 DEG C, produces strong boiling in dense preparing tank
It rises and convection current.
By convection current and boiling, the mixture in dense preparing tank is adequately stirred, and active carbon is adequately adsorbed.It is right
Stream and boiling 13-16 minutes, preferably 15 minutes.
Medical fluid is precipitated 20 minutes, and is cooled to 55-65 DEG C in precipitation process；In the process, the object in dense preparing tank
Layering is generated, is above supernatant layer, there is a small amount of active carbon, bottom is muddy liquid active carbon precipitating.
It utilizes the pipe compared with Large Diameter Pipeline to be quickly put into Clear liquid tank the supernatant after precipitating, is then begun through by Clear liquid tank
Decarbonization device enters dilute preparing tank after carrying out decarburization.Decarbonization device can use stud decarbonization device, can also use ultrafiltration membrane mistake
Filter is filtered using stud here.
After supernatant discharges, muddy liquid active carbon precipitating is started to process, first muddy liquid active carbon is precipitated using stud and is carried out
Primary filtering is slowly filtered by pressurizeing to Clear liquid tank.Since supernatant activated carbon content is low, filter to the mistake of dilute preparing tank
Cheng Feichang is fast, can save the process the time, and during supernatant is filtered from Clear liquid tank to dilute preparing tank, muddy liquid active carbon precipitating is same
When filter to Clear liquid tank, thus than more saving the time to dilute preparing tank from dense preparing tank by object whole disposable filtering in tank.
After being transferred to dilute preparing tank, full dose water for injection is added, temperature fluid temperature is 55-65 DEG C in dilute preparing tank at this time, root
According to pressure and water boiling point relationship, reach boiling point in dilute preparing tank when -76KPa is to -85KPa, taking temperature is 60 DEG C, vacuum degree is -
81KPa.Generation convection current and boiling in dilute preparing tank is set to mix object in tank dilute preparing tank bottom-heated using electromagnetism, after 6-14 minutes
50-60 DEG C of fluid temperature is adjusted after minute, and be filled with pure air to make to balance in dilute preparing tank with ambient atmosphere, stop convection current and boiling
It rises.Start filling.After tank band packaging sterilizing, will be filling after injection together with package body carry out water-bath sterilization, water-bath sterilization temperature
121 DEG C, the time 10 minutes of degree.
The present invention dense preparing tank, dissolving tank, dilute preparing tank tank body in for extract vacuum state answered when tank body to be opened
It is filled in clean gas air to tank body and is balanced with atmospheric pressure in the ban, then can opening.Therefore, in dosing plus active carbon into tank body；Or
When being directed into another tank body from a tank body, it should first be filled in clean gas air to tank body and be balanced with atmospheric pressure, then can opening.
The present invention adds Fluconazole, the mode for being eventually adding sodium chloride carries out concentrated compounding, obtains using water for injection is first added
Obtain mixing more evenly.
Active carbon main function in this product production technology is the pyrogen removed in medical fluid, adsorbs impurity and color in medical fluid
Element.
Active carbon studies medical fluid adsorption time:
Prepare 2000 bags (200L) by recipe quantity (100% feeds intake), be divided into 5 groups, every group with different activated carbon adsorptions when
Between, testing result is following (table one):
By upper table data analysis shows: (every group of dosage is 0.01%w/ for the comparison of different activated carbon adsorption time
V), there are micro- color or visible foreign matters unqualified within 10 minutes or less, can reach within 10 minutes or more adsorbing contaminant, decoloration and removal heat
The purpose of former, while drug content is influenced smaller, it then follows existing technique is set activated carbon adsorption in 15 minutes by principle of optimality,
Keep product inherent quality more excellent.
The sterilizing parameter of fluorine exchange is by can be 121 DEG C, and 30min or of the invention 121 DEG C,
10min.By recipe quantity (100% feeds intake) pilot sample, 2000 bags of every batch of (200L), testing result is following (table two):
By (table two) data analysis shows: product appearance character of this product under the conditions of two kinds of sterilizing parameters does not almost have
It changes, pH value is declined slightly, and 121 DEG C, for the fall △ PH under 30min sterilising conditions than 121 DEG C, 10min is bigger；It is insoluble
Property particle, pyrogen, sterility test, clarity meet regulation；Value >=12 F0 under the conditions of two kinds of sterilizing parameters can reach most
The requirement to sterilize eventually, Fluconazole mark percentage composition slightly decline, but 121 DEG C, the fall under 30min sterilising conditions
Than 121 DEG C, 10min is bigger, and the content of sodium chloride does not almost change；Related substances are under the conditions of two kinds of sterilizing parameters
Ascendant trend, and change obvious, still, 121 DEG C, for the ascensional range under 30min sterilising conditions than 121 DEG C, 10min is big, poor
It is different significant, cause product to reduce in the safety of clinical use, while time of the previous parameter than latter parameter in mass production
It grows, production energy consumption is big, increases the cost of production, it then follows principle of optimality is made in product using 121 DEG C, 10min in matter
It measures more excellent.
Above embodiment is used to illustrate the present invention, rather than limits the invention, in spirit of the invention
In scope of protection of the claims, to any modifications and changes that the present invention makes, protection scope of the present invention is both fallen within.
Claims (6)
1. a kind of fluconazole injection production technology, by being formed with liquid, filling, sterilization process, which is characterized in that specifically:
(1), water for injection 76%-79% is added in dense preparing tank, and dense preparing tank is added after Fluconazole is dissolved and mixes to form medicine
Liquid controls fluid temperature at 77-80 DEG C；
(3), it stirs, is adsorbed after active carbon being added into dense preparing tank；
(5), decarburization；
(6), it is directed into dilute preparing tank and is mixed after adding to the full amount of water for injection, filter, obtain injection；
(7), filling and sterilize, obtain finished product.
2. a kind of fluconazole injection production technology as described in claim 1, which is characterized in that described that Fluconazole is molten
Solution, method particularly includes: Fluconazole raw material and water for injection 120L are added in dissolving tank and are sealed dissolving tank, it will be in dissolving tank
Vacuum is extracted to -150Pa, 2-3 minute in sonic oscillation dissolving tank, until Fluconazole all imports dense preparing tank after dissolution, and by
After extracting vacuum -100Pa to -1000pa in dissolving tank, sonic oscillation cleans dissolving tank, and cleaning solution imports dense preparing tank.
3. a kind of fluconazole injection production technology as described in claim 1, which is characterized in that described to add into dense preparing tank
It stirs, is adsorbed after entering active carbon, specifically, the ratio of 0.2g active carbon is added into dense preparing tank in every 1000 milliliters of medical fluids
Active carbon is added, vacuum will be extracted in dense preparing tank to -59KPa to -53KPa, and using 80-85 DEG C to concentrated compounding tank body bottom-heated
Make to generate convection current and boiling in hermetically sealed can, is stirred and adsorbs 13-16 minutes by convection current and boiling.
4. a kind of fluconazole injection production technology as described in claim 1, which is characterized in that the decarburization specifically,
Medical fluid is precipitated 20 minutes, and is cooled to 55-65 DEG C in precipitation process；Supernatant after precipitating is quickly put into Clear liquid tank,
Bottom liquid after precipitating is slowly filtered by pressurization to Clear liquid tank；Dilute preparing tank is directed into after liquid filtering decarburization in Clear liquid tank liquid.
5. a kind of fluconazole injection production technology as described in claim 1, which is characterized in that described injects water to
It is mixed after full dose, specifically: it adds to the full amount of water for injection, vacuum will be extracted in dilute preparing tank to -76KPa to -85KPa, and utilize
60-70 DEG C, to dilute preparing tank bottom-heated, makes to generate convection current and boiling in dilute preparing tank, mixes object in tank, adjusts after 6-14 minutes
45 DEG C of fluid temperature, and being filled with pure air keeps dilute preparing tank interior and ambient atmosphere balance, stops convection current and boils.
6. a kind of fluconazole injection production technology as described in claim 1, which is characterized in that the sterilizing specifically:
Injection after will be filling carries out water-bath sterilization together with package body, and 121 DEG C of water-bath sterilization temperature, time 9-10 minute.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201811609130.XA CN109512781A (en) | 2018-12-27 | 2018-12-27 | A kind of fluconazole injection production technology |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811609130.XA CN109512781A (en) | 2018-12-27 | 2018-12-27 | A kind of fluconazole injection production technology |
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| CN109512781A true CN109512781A (en) | 2019-03-26 |
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Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104012920A (en) * | 2014-06-25 | 2014-09-03 | 河南京华食品科技开发有限公司 | Compound seasoning prepared by combining vacuum frying and microcapsule embedding technology |
| CN104187616A (en) * | 2014-07-29 | 2014-12-10 | 湖南奇异生物科技有限公司 | Okra whole-fruit nutrition powder |
| CN105708852A (en) * | 2016-03-18 | 2016-06-29 | 海南华拓天涯制药有限公司 | Fluconazole and sodium chloride injection and preparation method thereof |
| CN106902077A (en) * | 2017-03-03 | 2017-06-30 | 安徽环球药业股份有限公司 | The compound method of fluorine exchange |
| US20180117162A1 (en) * | 2016-11-01 | 2018-05-03 | International Business Machines Corporation | Vitamin functionalized gel-forming block copolymers for biomedical applications |
-
2018
- 2018-12-27 CN CN201811609130.XA patent/CN109512781A/en not_active Withdrawn
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104012920A (en) * | 2014-06-25 | 2014-09-03 | 河南京华食品科技开发有限公司 | Compound seasoning prepared by combining vacuum frying and microcapsule embedding technology |
| CN104187616A (en) * | 2014-07-29 | 2014-12-10 | 湖南奇异生物科技有限公司 | Okra whole-fruit nutrition powder |
| CN105708852A (en) * | 2016-03-18 | 2016-06-29 | 海南华拓天涯制药有限公司 | Fluconazole and sodium chloride injection and preparation method thereof |
| US20180117162A1 (en) * | 2016-11-01 | 2018-05-03 | International Business Machines Corporation | Vitamin functionalized gel-forming block copolymers for biomedical applications |
| CN106902077A (en) * | 2017-03-03 | 2017-06-30 | 安徽环球药业股份有限公司 | The compound method of fluorine exchange |
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Application publication date: 20190326 |