CN109364777B - Preparation method and device of mezlocillin sodium and sulbactam sodium mixed powder - Google Patents
Preparation method and device of mezlocillin sodium and sulbactam sodium mixed powder Download PDFInfo
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- CN109364777B CN109364777B CN201811247873.7A CN201811247873A CN109364777B CN 109364777 B CN109364777 B CN 109364777B CN 201811247873 A CN201811247873 A CN 201811247873A CN 109364777 B CN109364777 B CN 109364777B
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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
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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
- 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
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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
- 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
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- 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
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- 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
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- 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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- 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
Abstract
The invention belongs to the technical field of medicinal preparations, and particularly relates to a preparation method and a device of mixed powder of mezlocillin sodium and sulbactam sodium. The mezlocillin sodium and sulbactam sodium are mixed in a mixing dryer, the negative pressure in the tank is adjusted to change the fluidity of the mixed powder raw material in the tank by using the methods of vacuumizing, back blowing at the bottom of a nitrogen tank and air replenishing at the top of the tank, and the flow blocking plate of a stirring paddle is added to change the mixing effect of the raw material in the mixing dryer. The preparation method can better ensure the mixing uniformity of the raw materials, and the result of testing the content uniformity of the mixed powder raw materials shows that the mixing effect can be completed in a short time and the uniformity of the mixed powder can be ensured.
Description
Technical Field
The invention belongs to the technical field of medicinal preparations, and particularly relates to a preparation method and a device of mixed powder of mezlocillin sodium and sulbactam sodium.
Background
The mezlocillin sodium and sulbactam sodium are required to be uniformly mixed according to the proportion before subpackaging, and the existing powder mixing mode is as follows: the preparation method comprises the steps of feeding materials according to a certain raw material proportion, starting stirring to mix after feeding is finished, discharging about 30kg of raw materials at the bottom of a tank after mixing for 20 minutes, adding the discharged raw materials into the tank again to stir, repeating the operation for 2 times, blending for 60 minutes, and accumulating the mixing time for 120 minutes. The former rotation that only utilizes the stirring mixes the raw materials, and needs the manual work to fall the material operation, has certain quality hidden danger like this, mainly embodies in following several aspects: (1) frequent material pouring increases the risk of sterility; (2) the raw materials at the bottom of the tank are not uniformly mixed or do not participate in mixing; (3) mixing at a fixed stirring speed may cause a difference in mixing effect depending on the amount of the mixed powder; (4) the uneven mixing of the mixed powder of the mezlocillin sodium and the sulbactam sodium can cause the uneven quality of the produced final products of the mezlocillin sodium and the sulbactam sodium for injection, and the medication safety exists.
Disclosure of Invention
The invention aims to overcome the defects of the prior art and provides a preparation method and a device of mixed powder of mezlocillin sodium and sulbactam sodium. The device is adopted for mixing, the mixing uniformity is high, the mixing time is short, and the realization is easy; the preparation method has simple process and good stirring effect, and is suitable for industrial production.
The preparation method of the mixed powder of mezlocillin sodium and sulbactam sodium, disclosed by the invention, comprises the following steps of:
(1) alternately feeding mezlocillin sodium and sulbactam sodium into a mixing dryer, wherein the stirring speed during feeding is 3 Hz;
(2) after the feeding is finished, closing a feeding port of the mixing dryer, vacuumizing the mixing dryer to minus 40Kpa to minus 50Kpa, adjusting the stirring speed to 20Hz, continuously performing back flushing on the bottom of the mixing dryer for 2 times by using nitrogen every 5 minutes at an interval of 3 seconds, vacuumizing the mixing dryer to minus 45Kpa to minus 50Kpa after the back flushing is finished, and performing back flushing on the top of the mixing dryer for 2 times by using nitrogen after the vacuum degree meets the requirement, wherein the interval of 2 seconds is every time; cyclically alternating the operation, wherein the total mixing time is 40 min;
(3) and after the mixing is finished, subpackaging the qualified mixed powder of the mezlocillin sodium and the sulbactam sodium in a sterilized raw material barrel, and sealing for later use.
Wherein:
when the feeding in the step (1) is carried out, the environment of a feeding area is A grade, the feeding temperature is less than 26 ℃, and the humidity is less than 40%.
The mass ratio of the mezlocillin sodium to the sulbactam sodium is 4: 1.
And (3) when the tank bottom nitrogen is subjected to back flushing in the step (2), setting the back flushing time of the tank bottom to be 3 seconds every time, and controlling the pressure of a nitrogen feeding pipeline connected with the back flushing port of the tank bottom to be 0.2-0.25 Mpa.
And (3) during back flushing of the top-filled nitrogen in the step (2), setting the back flushing time of the tank top to be 2 seconds every time, and controlling the pressure of a nitrogen feeding pipeline connected with the back flushing port of the tank top to be 0.2-0.25 MPa.
The preparation device of the mixed powder of mezlocillin sodium and sulbactam sodium is a mixing dryer; the mixing dryer comprises a tank cover and a tank body, wherein a stirring motor is arranged in the middle of the upper part of the tank cover, an output shaft of the stirring motor extends into the tank body, a stirring fin is arranged on the output shaft, a feeding hole is formed in one side of the upper part of the tank cover, a vacuum collector is arranged on the other side of the upper part of the tank cover and is connected with a vacuum pipeline, the vacuum pipeline is connected with a vacuum generating device, a tank top nitrogen inlet is formed in the side wall of the vacuum pipeline, and a tank bottom nitrogen back-flushing hole is formed in one side of the bottom of the tank body; the bottom of the tank body is provided with a pneumatic semi-ball valve, and the lower part of the pneumatic semi-ball valve is a tank bottom discharge hole.
The stirring fin is provided with a spoiler, and the spoiler with an inclination angle of 60 degrees is added on the stirring fin every 10cm according to the vertical height.
The upper part of the tank body is cylindrical, and the lower part of the tank body is conical; the stirring fin is adapted to the lower structure of the tank body.
A cooling water inlet is arranged on one side of the lower part of the tank body, and a cooling water outlet is arranged on the upper part of the tank body; the other side of the lower part of the tank body is provided with a sterile sampler.
The invention obviously shortens the powder mixing time, obviously improves the mixing uniformity, and improves the uniformity of each component after the product is subpackaged and the safety of clinical medication. The preparation method provided by the invention uses the methods of vacuumizing, nitrogen tank bottom back flushing and tank top air replenishing, changes the fluidity of the mixed powder raw material in the tank by using negative pressure regulation in the tank, and simultaneously increases the flow blocking plate of the stirring fin to change the mixing effect of the raw material in the powder mixing tank, so that the mixing uniformity of the raw material can be better ensured.
As a preferable technical scheme, the preparation method of the mezlocillin sodium and sulbactam sodium mixed powder specifically comprises the following steps:
(1) and (3) alternately feeding mezlocillin sodium and sulbactam sodium into the mixing dryer from a feeding port, wherein the stirring speed during feeding is 3 Hz.
(2) After the feeding is finished, closing a feeding port of the mixing dryer, and vacuumizing through a vacuum generating device connected with a vacuum pipeline on a vacuum catcher on a tank cover to ensure that the vacuum in the mixing dryer tank is between-40 Kpa and-50 Kpa; adjusting the stirring speed to 20Hz, continuously back-blowing the bottom of the mixing dryer with nitrogen for 2 times through a tank bottom nitrogen back-blowing port every 5 minutes, wherein the interval of each time is 3 seconds, and controlling the pressure of a nitrogen feeding pipeline communicated with the tank bottom nitrogen back-blowing port to be 0.2-0.25 Mpa; after the back flushing is finished, vacuumizing the interior of the mixing dryer to-45 Kpa to-50 Kpa, and after the vacuum degree meets the requirement, carrying out back flushing on the nitrogen at the top of the tank for 2 times by the mixing dryer through a nitrogen inlet at the top of the tank, wherein the interval is 2 seconds every time, and the pressure of a nitrogen feeding pipeline communicated with the back flushing port at the top of the tank is controlled to be 0.2Mpa to 0.25 Mpa; this operation was cyclically alternated with a total mixing time of 40 min.
(3) And after the mixing is finished, subpackaging the qualified mixed powder of the mezlocillin sodium and the sulbactam sodium in a sterilized raw material barrel, and sealing for later use.
Compared with the prior art, the invention has the following beneficial effects:
(1) the flow blocking plate is added, so that the risk that the raw materials on the tube wall do not participate in mixing due to the fact that the powder is hung on the wall is avoided; on the other hand, the overturning and mixing effect of the mezlocillin sodium and the sulbactam sodium in the tank is improved.
(2) The mode of adopting the evacuation changes the frictional resistance of raw materials in the jar, makes the raw materials be in fluffy state under the condition of reduction resistance, more is favorable to the stirring, improves stirring effect, shortens the mix time.
(3) Utilize nitrogen pressure and jar interior vacuum at the tank bottoms, carry out the blowback to tank bottoms raw materials, make tank bottoms raw materials upwards shift, participate in whole mixing process, avoid appearing tank bottoms raw materials and not participate in mixing or mix inhomogeneous quality hidden danger.
(4) Nitrogen is introduced into the tank top, the raw materials in the tank are subjected to back blowing in a vacuum state, so that the pressure of the raw materials is increased, the attaching degree of the raw materials and the stirring is increased, and the stirring effect is more obvious.
(5) The preparation method provided by the invention is simple in process, good in stirring effect and suitable for industrial production.
Drawings
FIG. 1 is a schematic diagram of a mixing dryer configuration;
FIG. 2 is a schematic diagram of the mixing and drying apparatus agitator baffle configuration.
In the figure: 1. a stirring motor; 2. a feed inlet; 3. a can lid; 4. stirring fins; 5. a tank body; 6. a spoiler; 7. a vacuum line; 8. a nitrogen inlet at the top of the tank; 9. a vacuum collector; 10. a cooling water outlet; 11. a cooling water inlet; 12. a nitrogen back flushing port at the bottom of the tank; 13. a pneumatic semi-ball valve; 14. a discharge hole at the bottom of the tank; 15. a sterile sampler; 16. and a vacuum generating device.
Detailed Description
The present invention is further described below with reference to examples.
All the starting materials used in the following examples and comparative examples are commercially available, except where otherwise specified.
Comparative example 1
The preparation method of the mixed powder of mezlocillin sodium and sulbactam sodium in the comparative example 1 specifically comprises the following steps:
(1) ensuring that the temperature of the A-grade feeding area is less than 26 ℃ and the humidity is less than 40 percent;
(2) 4000g of mezlocillin sodium and 1000g of sulbactam sodium are alternately fed into the tank, and the stirring speed during feeding is 5 Hz;
(3) after the feeding is finished, starting stirring at the stirring speed of 30Hz, and mixing for 20 minutes; discharging about 30kg of raw materials at the bottom of the tank, adding the discharged raw materials into the tank again for stirring, repeating the operation for 2 times, blending for 60 minutes, and accumulating the mixing time for 120 minutes;
(4) after the mixing is finished, the raw materials are discharged from the bottom of the tank for standby.
Example 1
The preparation method of the mixed powder of mezlocillin sodium and sulbactam sodium described in this embodiment 1 specifically includes the following steps:
(1) ensuring that the temperature of the A-grade feeding area is less than 26 ℃ and the humidity is less than 40 percent;
(2) 4000g of mezlocillin sodium and 1000g of sulbactam sodium are alternately fed into the tank, and the stirring speed during feeding is 3 Hz;
(3) after the feeding is finished, closing a feeding port of the mixing dryer, vacuumizing the powder mixing tank to-40 Kpa to-50 Kpa, adjusting the stirring speed to 20Hz, continuously performing back flushing on the tank bottom by using nitrogen for 2 times every 5 minutes at an interval of 3 seconds every time, vacuumizing the tank to-45 Kpa to-50 Kpa after the back flushing is finished, performing back flushing on the nitrogen on the tank top for 2 times at an interval of 3 seconds every time after the vacuum degree meets the requirement, and vacuumizing the powder mixing tank to-40 Kpa to-50 Kpa after the back flushing on the tank top is finished; cyclically alternating the operation, wherein the total mixing time is 40 min;
(4) after the mixing is finished, subpackaging the qualified mixed intermediate product in a sterilized raw material barrel, and sealing for later use.
The preparation device of the mixed powder of mezlocillin sodium and sulbactam sodium described in the embodiment 1 is a mixing dryer; the mixing dryer comprises a tank cover 3 and a tank body 5, wherein a stirring motor 1 is arranged in the middle of the upper part of the tank cover 3, an output shaft of the stirring motor 1 extends into the tank body 5, a stirring fin 4 is arranged on the output shaft, a feeding port 2 is arranged on one side of the upper part of the tank cover 3, a vacuum collector 9 is arranged on the other side of the upper part of the tank cover 3, the vacuum collector 9 is connected with a vacuum pipeline 7, the vacuum pipeline 7 is connected with a vacuum generating device 16, a tank top nitrogen inlet 8 is arranged on the side wall of the vacuum pipeline 7, and a tank bottom nitrogen back-flushing port 12 is arranged on one side of the bottom of the tank body 5; the bottom of the tank body 5 is provided with a pneumatic half-ball valve 13, and the lower part of the pneumatic half-ball valve 13 is provided with a tank bottom discharge hole 14.
The stirring fin 4 is provided with a spoiler 6, and the spoiler 6 with an inclination angle of 60 degrees is added on the stirring fin 4 every 10cm according to the vertical height.
The upper part of the tank body 5 is cylindrical, and the lower part is conical; the stirring fin 4 is adapted to the lower structure of the tank body 5.
A cooling water inlet 11 is arranged on one side of the lower part of the tank body 5, and a cooling water outlet 10 is arranged on the upper part of the tank body 5; the other side of the lower part of the tank body 5 is provided with a sterile sampler 15.
And (3) quality evaluation:
the mixed powder of mezlocillin and sulbactam sodium prepared in comparative example 1 (original powder mixing process) and example 1 (improved powder mixing process) was subjected to quality comparison, and the quality comparison results are shown in table 1.
TABLE 1 comparison of the quality of the powder-mixing process
As can be seen from the data in Table 1, by adopting the new powder mixing process, the mixing uniformity of the mezlocillin sodium and the sulbactam sodium is higher than that of the original powder mixing process, the content difference of the mixed components in the tank is smaller, the quality difference of the finished product for subpackaging is also reduced, and the safety of clinical medication is improved.
Claims (7)
1. A preparation method of mixed powder of mezlocillin sodium and sulbactam sodium is characterized in that: the method specifically comprises the following steps:
(1) alternately feeding mezlocillin sodium and sulbactam sodium into a mixing dryer, wherein the stirring speed during feeding is 3 Hz;
(2) after the feeding is finished, closing a feeding port of the mixing dryer, vacuumizing the mixing dryer to minus 40Kpa to minus 50Kpa, adjusting the stirring speed to 20Hz, continuously performing back flushing on the bottom of the mixing dryer for 2 times by using nitrogen every 5 minutes at an interval of 3 seconds, vacuumizing the mixing dryer to minus 45Kpa to minus 50Kpa after the back flushing is finished, and performing back flushing on the top of the mixing dryer for 2 times by using nitrogen after the vacuum degree meets the requirement, wherein the interval of 2 seconds is every time; cyclically alternating the operation, wherein the total mixing time is 40 min;
(3) after mixing, subpackaging the qualified mixed powder of mezlocillin sodium and sulbactam sodium in a sterilized raw material barrel, and sealing for later use;
the mixing dryer comprises a tank cover (3) and a tank body (5), wherein a stirring motor (1) is arranged in the middle of the upper portion of the tank cover (3), an output shaft of the stirring motor (1) extends into the tank body (5), stirring wings (4) are arranged on the output shaft, a feeding port (2) is arranged on one side of the upper portion of the tank cover (3), a vacuum collector (9) is arranged on the other side of the upper portion of the tank cover (3), the vacuum collector (9) is connected with a vacuum pipeline (7), the vacuum pipeline (7) is connected with a vacuum generating device (16), a tank top nitrogen inlet (8) is arranged on the side wall of the vacuum pipeline (7), and a tank bottom nitrogen back-blowing port (12) is arranged on one side of the bottom of the tank body (5); a pneumatic semi-ball valve (13) is arranged at the bottom of the tank body (5), and a tank bottom discharge hole (14) is formed in the lower part of the pneumatic semi-ball valve (13);
the stirring wings (4) are provided with spoilers (6), and the spoilers (6) with the inclination angle of 60 degrees are added on the stirring wings (4) at intervals of 10cm according to the vertical height.
2. The method for preparing the mezlocillin sodium and sulbactam sodium mixed powder as claimed in claim 1, wherein the method comprises the following steps: and (2) feeding in the step (1), wherein the environment of a feeding area is A grade, the feeding temperature is less than 26 ℃, and the humidity is less than 40%.
3. The method for preparing the mezlocillin sodium and sulbactam sodium mixed powder as claimed in claim 1, wherein the method comprises the following steps: the mass ratio of the mezlocillin sodium to the sulbactam sodium is 4: 1.
4. The method for preparing the mezlocillin sodium and sulbactam sodium mixed powder as claimed in claim 1, wherein the method comprises the following steps: and (3) when the tank bottom nitrogen is subjected to back flushing in the step (2), setting the back flushing time of the tank bottom to be 3 seconds every time, and controlling the pressure of a nitrogen feeding pipeline communicated with the tank bottom nitrogen back flushing port to be 0.2-0.25 MPa.
5. The method for preparing the mezlocillin sodium and sulbactam sodium mixed powder as claimed in claim 1, wherein the method comprises the following steps: and (3) during back flushing of the top-filled nitrogen in the step (2), setting the back flushing time of the tank top to be 2 seconds every time, and controlling the pressure of a nitrogen feeding pipeline communicated with the back flushing port of the tank top to be 0.2-0.25 MPa.
6. The method for preparing the mezlocillin sodium and sulbactam sodium mixed powder as claimed in claim 1, wherein the method comprises the following steps: the upper part of the tank body (5) is cylindrical, and the lower part of the tank body is conical; the stirring fin (4) is adapted to the lower structure of the tank body (5).
7. The method for preparing the mezlocillin sodium and sulbactam sodium mixed powder as claimed in claim 1, wherein the method comprises the following steps: a cooling water inlet (11) is arranged on one side of the lower part of the tank body (5), and a cooling water outlet (10) is arranged on the upper part of the tank body (5); the other side of the lower part of the tank body (5) is provided with a sterile sampler (15).
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| 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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| 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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| CN109912795B (en) * | 2019-01-16 | 2021-07-02 | 河南神马尼龙化工有限责任公司 | Production method of high-quality poly (p-phenylene terephthalamide) resin and PPD dissolving kettle |
| 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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| WO2004066976A1 (en) * | 2003-01-28 | 2004-08-12 | Röhm GmbH & Co. KG | Method for producing an immediately decomposing oral form of administration which releases active ingredients |
| WO2008048728A1 (en) * | 2006-10-20 | 2008-04-24 | Mead Johnson Nutrition Company | Conical screw blender |
| CN102526040A (en) * | 2012-01-21 | 2012-07-04 | 苏州二叶制药有限公司 | Method for preparing composition of mezlocillin sodium and sulbactam sodium for injection in ratio of 4: 1 |
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Address after: 256100 Ruiyang Road, Yiyuan County, Zibo City, Shandong Province Applicant after: Ruiyang Pharmaceutical Co.,Ltd. Address before: 256100 Ruiyang Road, Yiyuan County, Zibo City, Shandong Province Applicant before: REYOUNG PHARMACEUTICAL Co.,Ltd. |
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Denomination of invention: Preparation method and device of mixed powder of mezlocillin sodium and sulbactam sodium Effective date of registration: 20211209 Granted publication date: 20210806 Pledgee: Commercial Bank of China Yiyuan branch of Limited by Share Ltd. Pledgor: Ruiyang Pharmaceutical Co.,Ltd. Registration number: Y2021980014543 |
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Date of cancellation: 20221012 Granted publication date: 20210806 Pledgee: Commercial Bank of China Yiyuan branch of Limited by Share Ltd. Pledgor: Ruiyang Pharmaceutical Co.,Ltd. Registration number: Y2021980014543 |