CN109364777A - Mezlocillin sodium and sulbactam mix the preparation method and device of powder - Google Patents
Mezlocillin sodium and sulbactam mix the preparation method and device of powder Download PDFInfo
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- CN109364777A CN109364777A CN201811247873.7A CN201811247873A CN109364777A CN 109364777 A CN109364777 A CN 109364777A CN 201811247873 A CN201811247873 A CN 201811247873A CN 109364777 A CN109364777 A CN 109364777A
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- tank
- sulbactam
- mixing
- mezlocillin sodium
- preparation
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Classifications
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
- B01F23/00—Mixing according to the phases to be mixed, e.g. dispersing or emulsifying
- B01F23/60—Mixing solids with solids
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
- B01F33/00—Other mixers; Mixing plants; Combinations of mixers
- B01F33/40—Mixers using gas or liquid agitation, e.g. with air supply tubes
- B01F33/402—Mixers using gas or liquid agitation, e.g. with air supply tubes comprising supplementary stirring elements
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
- B01F33/00—Other mixers; Mixing plants; Combinations of mixers
- B01F33/70—Mixers specially adapted for working at sub- or super-atmospheric pressure, e.g. combined with de-foaming
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F26—DRYING
- F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
- F26B11/00—Machines or apparatus for drying solid materials or objects with movement which is non-progressive
- F26B11/12—Machines or apparatus for drying solid materials or objects with movement which is non-progressive in stationary drums or other mainly-closed receptacles with moving stirring devices
- F26B11/14—Machines or apparatus for drying solid materials or objects with movement which is non-progressive in stationary drums or other mainly-closed receptacles with moving stirring devices the stirring device moving in a horizontal or slightly-inclined plane
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F26—DRYING
- F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
- F26B21/00—Arrangements or duct systems, e.g. in combination with pallet boxes, for supplying and controlling air or gases for drying solid materials or objects
- F26B21/14—Arrangements or duct systems, e.g. in combination with pallet boxes, for supplying and controlling air or gases for drying solid materials or objects using gases or vapours other than air or steam, e.g. inert gases
-
- 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
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
- B01F2101/00—Mixing characterised by the nature of the mixed materials or by the application field
- B01F2101/22—Mixing of ingredients for pharmaceutical or medical compositions
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- Engineering & Computer Science (AREA)
- Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Mechanical Engineering (AREA)
- General Engineering & Computer Science (AREA)
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Molecular Biology (AREA)
- Medicinal Preparation (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
Abstract
The invention belongs to technical field of medicine, are specifically related to the preparation method and device of a kind of mezlocillin sodium and the mixed powder of sulbactam.Mezlocillin sodium and sulbactam are mixed in mixing drier, using vacuumize, the method for the blowback of nitrogen gas tank bottom, tank deck tonifying Qi, it is adjusted using the negative pressure in tank to change mobility of the mixed powder raw material in tank, the spoiler for increasing agitating paddle simultaneously, carrys out mixed effect of the feed change in mixing drier tank with this.Preparation method of the present invention can preferably guarantee the mixing homogeneity of raw material, it is tested through the content uniformity to mixed powder raw material, it can be completed in a short time mixed effect as the result is shown, and can guarantee the uniformity of mixed powder, which is suitable for industrialized production.
Description
Technical field
The invention belongs to technical field of medicine, are specifically related to the system of a kind of mezlocillin sodium and the mixed powder of sulbactam
Preparation Method and device.
Background technique
Mezlocillin sodium and sulbactam need proportionally uniformly to be mixed before packing, present Style of mixing powder
Are as follows: it feeds intake according to certain material rate, after feeding intake, opens stirring and mixed, mixed after twenty minutes by tank bottom
Raw material release 30kg or so, the raw material of releasing is added in tank again and is stirred, repeats this operation 2 times, co-blended 60 is divided
Clock adds up incorporation time and needs 120 minutes.Raw material is mixed just with the rotation of stirring before, and need manually into
Row batch turning operation, has certain hidden danger of quality in this way, be mainly reflected in the following aspects: (1) frequently batch turning operation increases
Sterile risk；(2) raw material of tank bottom, which exists, mixes risk that is uneven or having neither part nor lot in mixing；(3) fixed stirring is utilized
Speed carry out mixing may because mix powder amount number cause mixed effect difference；(4) mezlocillin sodium and sulbactam
Mixed powder raw material mixes the inhomogenous final products mezlocillin for injection that may cause production and sulbactam will appear quality
Inhomogenous situation, there are drug safeties.
Summary of the invention
The purpose of the present invention is overcome the deficiencies of the prior art and provide the system of a kind of mezlocillin sodium and the mixed powder of sulbactam
Preparation Method and device.It is mixed using the device, mixing homogeneity is high, and incorporation time is short, it is easy to accomplish；The preparation method work
Skill is simple, and mixing effect is good, is suitable for industrialized production.
Mezlocillin sodium and sulbactam of the present invention mix the preparation method of powder, specifically includes the following steps:
(1) mezlocillin sodium and sulbactam are alternately fed intake into mixing drier, mixing speed when feeding intake is
3Hz；
(2) after feeding intake, close mixing drier feed opening, take out mixing drier tank in vacuum to -40Kpa to -
50Kpa, mixing speed are adjusted to 20Hz, use the continuous blowback of nitrogen 2 times in mixing drier tank bottom within every 5 minutes, every minor tick 3
Second, vacuum is taken out in mixing drier tank after blowback to -45Kpa to -50Kpa, vacuum degree reaches that carry out mixing after requirement dry
Dry the blowback of device tank deck nitrogen 2 times, every minor tick 2 seconds；This operation of cycle alternation, total incorporation time are 40min；
(3) after mixing, the qualified mezlocillin sodium of mixing and sulbactam are mixed into the raw material of powder packing after sterilization
In bucket, seal spare.
Wherein:
Described in step (1) when feeding intake, the regional environment that feeds intake be A grades, 26 DEG C of feed temperature <, humidity < 40%.
The mass ratio of mezlocillin sodium and sulbactam is 4:1.
Described in step (2) when tank bottom nitrogen blowback, each tank bottom blowback time is set as 3 seconds, anti-with tank bottom nitrogen
The nitrogen feed pipeline pressure of mouthpiece connection is controlled in 0.2Mpa-0.25Mpa Mpa.
Described in step (2) when abhiseca nitrogen blowback, each tank deck blowback time is set as 2 seconds, anti-with tank deck nitrogen
The nitrogen feed pipeline pressure of mouthpiece connection is controlled in 0.2Mpa-0.25Mpa.
The preparation facilities that mezlocillin sodium and sulbactam of the present invention mix powder is mixing drier；Mixing drier
Including cover and tank body, stirring motor is arranged in cover upper middle position, and stirring motor output shaft is deep into tank body, output shaft
Be equipped with stirring wing, cover top side be equipped with feed opening, the cover top other side be equipped with vacuum supplementary set device, vacuum supplementary set device with
Vacuum line connection, vacuum line are connect with vacuum generating device, and the side wall of vacuum line is equipped with tank deck nitrogen inlet, tank body
Bottom side is equipped with tank bottom nitrogen back blow port；Tank base is equipped with pneumatic semisphere valve, and pneumatic semisphere valve lower part is tank bottom discharge port.
Stirring wing is equipped with spoiler, and increasing an inclination angle every 10cm according to vertical height on stirring wing is 60 degree
Spoiler.
Tank body top is cylinder, and lower part is cone-shaped；The substructure of stirring wing and tank body is adapted.
Tank body lower part side is equipped with cooling water inlet, and tank body top is equipped with cooling water outlet；The tank body lower part other side is equipped with
Aseptic sampler.
The present invention is obviously shortened mixing time, and mixture homogeneity is significantly improved, and improves each group after product packing
The safety of the uniformity and clinical application divided.Preparation method of the present invention, using vacuumize, the blowback of nitrogen gas tank bottom, tank
The method for pushing up tonifying Qi is adjusted to change mobility of the mixed powder raw material in tank using the negative pressure in tank, while increasing stirring wing
Spoiler carrys out mixed effect of the feed change in mixed powder tank with this, can preferably guarantee the mixing homogeneity of raw material, through to mixed
The content uniformity of powder raw material is tested, and can be completed in a short time mixed effect as the result is shown, and can guarantee the equal of mixed powder
Even property, the preparation method simple process are suitable for industrialized production.
As a preferred technical solution, mezlocillin sodium and sulbactam of the present invention mix the preparation side of powder
Method, specifically includes the following steps:
(1) mezlocillin sodium and sulbactam are alternately fed intake from feed opening into mixing drier, stirring when feeding intake
Speed is 3Hz.
(2) after feeding intake, mixing drier feed opening is closed, by connecting on vacuum trap on cover with vacuum line
The vacuum generating device connect carries out vacuum pumping, makes in mixing drier tank vacuum in -40Kpa to -50Kpa；Mixing speed
It is adjusted to 20Hz, passes through tank bottom nitrogen back blow port using the continuous blowback of nitrogen 2 times, every time in mixing drier tank bottom within every 5 minutes
Interval 3 seconds, the nitrogen feed pipeline pressure communicated with tank bottom nitrogen back blow port are controlled in 0.2Mpa-0.25Mpa；After blowback
Vacuum extremely -45Kpa to -50Kpa in mixing drier tank is taken out, progress mixing drier passes through tank deck nitrogen after vacuum degree reaches requirement
Gas entrance carries out the blowback of tank deck nitrogen 2 times, every minor tick 2 seconds, the nitrogen feed pipeline pressure communicated with tank deck nitrogen back blow port
Control is in 0.2Mpa-0.25Mpa；This operation of cycle alternation, total incorporation time are 40min.
(3) after mixing, the qualified mezlocillin sodium of mixing and sulbactam are mixed into the raw material of powder packing after sterilization
In bucket, seal spare.
Compared with the prior art, the present invention has the following beneficial effects:
(1) increase spoiler, on the one hand avoid the occurrence of the risk that medicinal powder wall built-up causes tube wall raw material to be not involved in mixing；It is another
Aspect improves the overturning mixed effect of mezlocillin sodium and sulbactam in tank.
(2) frictional resistance of the feed change in tank makes at raw material in the case where reducing resistance by the way of vacuumizing
In soft fluffy state, it is more advantageous to stirring, improves mixing effect, shortens incorporation time.
(3) blowback is carried out to tank bottom raw material, tank bottom raw material is promoted to turn upwards using vacuum in nitrogen pressure and tank in tank bottom
It moves, participates in entire mixed process, avoid the occurrence of tank bottom raw material and be not involved in mixing or the non-uniform hidden danger of quality of mixing.
(4) it being passed through nitrogen in tank deck, raw material is in blowback under vacuum state in tank, and it is equivalent to and increases pressure to raw material,
Increase the compactness of raw material and stirring, the effect of stirring becomes apparent.
(5) preparation method of the present invention, simple process, mixing effect is good, is suitable for industrialized production.
Detailed description of the invention
Fig. 1 is mixing drier structural schematic diagram；
Fig. 2 is mixing drier stirring spoiler structural schematic diagram.
In figure: 1, stirring motor；2, feed opening；3, cover；4, stirring wing；5, tank body；6, spoiler；7, vacuum line；
8, tank deck nitrogen inlet；9, vacuum supplementary set device；10, cooling water outlet；11, cooling water inlet；12, tank bottom nitrogen back blow port；13,
Pneumatic semisphere valve；14, tank bottom discharge port；15, aseptic sampler；16, vacuum generating device.
Specific embodiment
The invention will be further described with reference to embodiments.
All raw materials used in the following example and comparative example are commercially available unless otherwise specified.
Comparative example 1
Mezlocillin sodium described in this comparative example 1 and sulbactam mix the preparation method of powder, specifically includes the following steps:
(1) ensure the temperature in the A grades of regions that feed intake at 26 DEG C of <, humidity < 40%；
(2) mezlocillin sodium 4000g, sulbactam 1000g are alternately fed intake into tank, mixing speed when feeding intake is
5Hz；
(3) after feeding intake, stirring is opened, mixing speed 30Hz is mixed 20 minutes；It is left that tank bottom raw material is released into 30kg
The raw material of releasing is added in tank again and is stirred by the right side, repeats this operation 2 times, co-blended 60 minutes, adding up incorporation time needed
Want 120 minutes；
(4) after mixing, raw material is spare from tank bottom releasing.
Embodiment 1
Mezlocillin sodium described in the present embodiment 1 and sulbactam mix the preparation method of powder, specifically includes the following steps:
(1) ensure the temperature in the A grades of regions that feed intake at 26 DEG C of <, humidity < 40%；
(2) mezlocillin sodium 4000g, sulbactam 1000g are alternately fed intake into tank, mixing speed when feeding intake is
3Hz；
(3) after feeding intake, mixing drier feeding port is closed, vacuum in mixed powder tank is taken out and is stirred to -40Kpa to -50Kpa
It mixes speed and is adjusted to 20Hz, used the continuous blowback of nitrogen 2 times in tank bottom within every 5 minutes, every minor tick 3 seconds takes out tank after blowback
Interior vacuum is to -45Kpa to -50Kpa, and vacuum degree carries out the blowback of tank deck nitrogen 2 times after reaching requirement, and every minor tick 3 seconds, tank deck is anti-
Vacuum extremely -40Kpa to -50Kpa in powder tank is mixed after blowing；This operation of cycle alternation, total incorporation time are 40min；
(4) it after mixing, by the Raw material pail of the qualified intermediate products packing of mixing after sterilization, seals spare.
The preparation facilities that mezlocillin sodium described in the present embodiment 1 and sulbactam mix powder is mixing drier；Mixing is dry
Dry device includes cover 3 and tank body 5, and stirring motor 1 is arranged in 3 upper middle position of cover, and 1 output shaft of stirring motor is deep into tank body
In 5, output shaft is equipped with stirring wing 4, and 3 top side of cover is equipped with feed opening 2, and the 3 top other side of cover is equipped with vacuum supplementary set
Device 9, vacuum supplementary set device 9 are connect with vacuum line 7, and vacuum line 7 is connect with vacuum generating device 16, the side wall of vacuum line 7
It is equipped with tank deck nitrogen inlet 8,5 bottom side of tank body is equipped with tank bottom nitrogen back blow port 12；5 bottom of tank body is equipped with pneumatic semisphere valve
13, pneumatic 13 lower part of semisphere valve is tank bottom discharge port 14.
Stirring wing 4 is equipped with spoiler 6, and increasing an inclination angle every 10cm according to vertical height on stirring wing 4 is 60
The spoiler 6 of degree.
5 top of tank body is cylinder, and lower part is cone-shaped；The substructure of stirring wing 4 and tank body 5 is adapted.
5 lower part side of tank body is equipped with cooling water inlet 11, and 5 top of tank body is equipped with cooling water outlet 10；5 lower part of tank body is another
Side is equipped with aseptic sampler 15.
Quality evaluation:
The mezlocillin and Na Shuba of comparative example 1 (former blending processes of powders) and embodiment 1 (improved blending processes of powders) preparation
Smooth sodium mixes powder and carries out quality versus, and quality versus the results are shown in Table 1.
1 blending processes of powders quality versus's result of table
New blending processes of powders is used it can be seen from 1 data of table, mezlocillin sodium mixes homogeneity with sulbactam and is higher than
Former hybrid technique, the content difference opposite sex of each component in tank is smaller after mixing, and the opposite sex of poor quality of the finished product for packing also can
Reduce, improves the safety of clinical application.
Claims (9)
1. the preparation method that a kind of mezlocillin sodium and sulbactam mix powder, it is characterised in that: specifically includes the following steps:
(1) mezlocillin sodium and sulbactam are alternately fed intake into mixing drier, mixing speed when feeding intake is 3Hz；
(2) after feeding intake, mixing drier feed opening is closed, takes out vacuum extremely -40Kpa to -50Kpa in mixing drier tank,
Mixing speed is adjusted to 20Hz, uses the continuous blowback of nitrogen 2 times in mixing drier tank bottom within every 5 minutes, every minor tick 3 seconds, instead
Vacuum in mixing drier tank is taken out after blowing, and, to -45Kpa to -50Kpa, vacuum degree carries out mixing drier tank after reaching requirement
Top nitrogen blowback 2 times, every minor tick 2 seconds；This operation of cycle alternation, total incorporation time are 40min；
(3) after mixing, the qualified mezlocillin sodium of mixing and sulbactam are mixed in the Raw material pail of powder packing after sterilization,
It seals spare.
2. the preparation method that mezlocillin sodium according to claim 1 and sulbactam mix powder, it is characterised in that: step
(1) feeding intake described in, the regional environment that feeds intake be A grades, 26 DEG C of feed temperature <, humidity < 40%.
3. the preparation method that mezlocillin sodium according to claim 1 and sulbactam mix powder, it is characterised in that: Mei Luoxi
The mass ratio of woods sodium and sulbactam is 4:1.
4. the preparation method that mezlocillin sodium according to claim 1 and sulbactam mix powder, it is characterised in that: step
(2) when tank bottom nitrogen blowback described in, each tank bottom blowback time is set as 3 seconds, the nitrogen communicated with tank bottom nitrogen back blow port
Gas feeding pipe pressure is controlled in 0.2Mpa-0.25Mpa Mpa.
5. the preparation method that mezlocillin sodium according to claim 1 and sulbactam mix powder, it is characterised in that: step
(2) when abhiseca nitrogen blowback described in, each tank deck blowback time is set as 2 seconds, the nitrogen communicated with tank deck nitrogen back blow port
Gas feeding pipe pressure is controlled in 0.2Mpa-0.25Mpa.
6. the preparation facilities that a kind of mezlocillin sodium described in claim 1 and sulbactam mix powder, it is characterised in that: preparation dress
It is set to mixing drier；Mixing drier includes cover (3) and tank body (5), and stirring motor is arranged in cover (3) upper middle position
(1), stirring motor (1) output shaft is deep into tank body (5), and output shaft is equipped with stirring wing (4), and cover (3) top side is set
Have feed opening (2), cover (3) the top other side is equipped with vacuum supplementary set device (9), and vacuum supplementary set device (9) and vacuum line (7) are even
It connecing, vacuum line (7) is connect with vacuum generating device (16), and the side wall of vacuum line (7) is equipped with tank deck nitrogen inlet (8),
Tank body (5) bottom side is equipped with tank bottom nitrogen back blow port (12)；Tank body (5) bottom is equipped with pneumatic semisphere valve (13), pneumatic hemisphere
Valve (13) lower part is tank bottom discharge port (14).
7. the preparation facilities that mezlocillin sodium according to claim 6 and sulbactam mix powder, it is characterised in that: stirring wing
(4) spoiler (6) are equipped with, increase the choked flow that an inclination angle is 60 degree every 10cm according to vertical height on stirring wing (4)
Plate (6).
8. the preparation facilities that mezlocillin sodium according to claim 6 and sulbactam mix powder, it is characterised in that: tank body
(5) top is cylinder, and lower part is cone-shaped；The substructure of stirring wing (4) and tank body (5) is adapted.
9. the preparation facilities that mezlocillin sodium according to claim 6 and sulbactam mix powder, it is characterised in that: tank body
(5) lower part side is equipped with cooling water inlet (11), and tank body (5) top is equipped with cooling water outlet (10)；Tank body (5) lower part other side
Equipped with aseptic sampler (15).
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811247873.7A CN109364777B (en) | 2018-10-25 | 2018-10-25 | Preparation method and device of mezlocillin sodium and sulbactam sodium mixed powder |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811247873.7A CN109364777B (en) | 2018-10-25 | 2018-10-25 | Preparation method and device of mezlocillin sodium and sulbactam sodium mixed powder |
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| CN109364777A true CN109364777A (en) | 2019-02-22 |
| CN109364777B CN109364777B (en) | 2021-08-06 |
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Cited By (2)
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| CN109912795A (en) * | 2019-01-16 | 2019-06-21 | 河南神马尼龙化工有限责任公司 | A kind of production method and PPD dissolution kettle of high-quality poly(p-phenylene terephthalamide) resin |
| CN116372194A (en) * | 2023-05-29 | 2023-07-04 | 成都先进金属材料产业技术研究院股份有限公司 | Device and method suitable for high-flux manufacturing of metal material |
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| Publication number | Publication date |
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| CN109364777B (en) | 2021-08-06 |
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