CN112345669A - Method for measuring ceftazidime polymer for injection - Google Patents
Method for measuring ceftazidime polymer for injection Download PDFInfo
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- CN112345669A CN112345669A CN202011288797.1A CN202011288797A CN112345669A CN 112345669 A CN112345669 A CN 112345669A CN 202011288797 A CN202011288797 A CN 202011288797A CN 112345669 A CN112345669 A CN 112345669A
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- 229960000484 ceftazidime Drugs 0.000 title claims abstract description 114
- NMVPEQXCMGEDNH-TZVUEUGBSA-N ceftazidime pentahydrate Chemical compound O.O.O.O.O.S([C@@H]1[C@@H](C(N1C=1C([O-])=O)=O)NC(=O)\C(=N/OC(C)(C)C(O)=O)C=2N=C(N)SC=2)CC=1C[N+]1=CC=CC=C1 NMVPEQXCMGEDNH-TZVUEUGBSA-N 0.000 title claims abstract description 114
- 238000000034 method Methods 0.000 title claims abstract description 29
- 229920000642 polymer Polymers 0.000 title claims abstract description 29
- 238000002347 injection Methods 0.000 title claims abstract description 17
- 239000007924 injection Substances 0.000 title claims abstract description 17
- 238000000746 purification Methods 0.000 claims abstract description 100
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims abstract description 88
- 239000000243 solution Substances 0.000 claims abstract description 68
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 58
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims abstract description 30
- KGWHMDCQVDMTNZ-UHFFFAOYSA-N 2-(butylcarbamoylamino)acetic acid Chemical compound CCCCNC(=O)NCC(O)=O KGWHMDCQVDMTNZ-UHFFFAOYSA-N 0.000 claims abstract description 27
- 229960003547 ceftazidime pentahydrate Drugs 0.000 claims abstract description 27
- 239000013078 crystal Substances 0.000 claims abstract description 14
- 239000002244 precipitate Substances 0.000 claims abstract description 14
- 238000001291 vacuum drying Methods 0.000 claims abstract description 14
- 239000007788 liquid Substances 0.000 claims description 83
- 239000008367 deionised water Substances 0.000 claims description 28
- 229910021641 deionized water Inorganic materials 0.000 claims description 28
- 238000007599 discharging Methods 0.000 claims description 27
- 238000003756 stirring Methods 0.000 claims description 24
- 238000009434 installation Methods 0.000 claims description 23
- 239000003513 alkali Substances 0.000 claims description 18
- 238000009833 condensation Methods 0.000 claims description 18
- 230000005494 condensation Effects 0.000 claims description 18
- 239000000725 suspension Substances 0.000 claims description 18
- 239000002253 acid Substances 0.000 claims description 17
- 239000000463 material Substances 0.000 claims description 12
- 238000005086 pumping Methods 0.000 claims description 10
- 238000007789 sealing Methods 0.000 claims description 9
- 238000004128 high performance liquid chromatography Methods 0.000 claims description 7
- 238000005192 partition Methods 0.000 claims description 5
- 230000007306 turnover Effects 0.000 claims description 5
- 238000007664 blowing Methods 0.000 claims description 2
- 230000008602 contraction Effects 0.000 claims description 2
- 230000001105 regulatory effect Effects 0.000 claims 4
- 238000003556 assay Methods 0.000 claims 1
- 239000000126 substance Substances 0.000 claims 1
- 239000000706 filtrate Substances 0.000 abstract description 2
- 238000001914 filtration Methods 0.000 abstract description 2
- 239000007864 aqueous solution Substances 0.000 abstract 1
- 208000015181 infectious disease Diseases 0.000 description 4
- 241000894006 Bacteria Species 0.000 description 3
- 230000000844 anti-bacterial effect Effects 0.000 description 3
- 241000192125 Firmicutes Species 0.000 description 2
- 230000003115 biocidal effect Effects 0.000 description 2
- 238000001514 detection method Methods 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
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- 206010056519 Abdominal infection Diseases 0.000 description 1
- 206010002198 Anaphylactic reaction Diseases 0.000 description 1
- 208000031729 Bacteremia Diseases 0.000 description 1
- 206010061695 Biliary tract infection Diseases 0.000 description 1
- 206010005940 Bone and joint infections Diseases 0.000 description 1
- 229930186147 Cephalosporin Natural products 0.000 description 1
- 108090000204 Dipeptidase 1 Proteins 0.000 description 1
- 241000194033 Enterococcus Species 0.000 description 1
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- 206010017964 Gastrointestinal infection Diseases 0.000 description 1
- 241000588748 Klebsiella Species 0.000 description 1
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- 241000588652 Neisseria gonorrhoeae Species 0.000 description 1
- 241000588650 Neisseria meningitidis Species 0.000 description 1
- 241000588769 Proteus <enterobacteria> Species 0.000 description 1
- 241000589517 Pseudomonas aeruginosa Species 0.000 description 1
- 206010057190 Respiratory tract infections Diseases 0.000 description 1
- 241000607142 Salmonella Species 0.000 description 1
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- 241000607768 Shigella Species 0.000 description 1
- 206010062255 Soft tissue infection Diseases 0.000 description 1
- 241000191967 Staphylococcus aureus Species 0.000 description 1
- 241000194017 Streptococcus Species 0.000 description 1
- 238000007792 addition Methods 0.000 description 1
- 208000003455 anaphylaxis Diseases 0.000 description 1
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- 229940088710 antibiotic agent Drugs 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 102000006635 beta-lactamase Human genes 0.000 description 1
- 229940124587 cephalosporin Drugs 0.000 description 1
- 150000001780 cephalosporins Chemical class 0.000 description 1
- 208000003167 cholangitis Diseases 0.000 description 1
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- 238000000502 dialysis Methods 0.000 description 1
- 208000019836 digestive system infectious disease Diseases 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
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- 230000002949 hemolytic effect Effects 0.000 description 1
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- 210000001503 joint Anatomy 0.000 description 1
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- 206010034674 peritonitis Diseases 0.000 description 1
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- 238000006467 substitution reaction Methods 0.000 description 1
- 208000019206 urinary tract infection Diseases 0.000 description 1
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/04—Preparation or injection of sample to be analysed
- G01N30/06—Preparation
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/04—Preparation or injection of sample to be analysed
- G01N30/06—Preparation
- G01N30/14—Preparation by elimination of some components
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- Physics & Mathematics (AREA)
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Analytical Chemistry (AREA)
- Biochemistry (AREA)
- General Health & Medical Sciences (AREA)
- General Physics & Mathematics (AREA)
- Immunology (AREA)
- Pathology (AREA)
- Cephalosporin Compounds (AREA)
Abstract
The invention discloses a method for determining ceftazidime polymer for injection, which comprises the steps of adding concentrated hydrochloric acid into ceftazidime pentahydrate water to dissolve the ceftazidime pentahydrate water, then adding a sodium hydroxide solution to adjust the pH of the ceftazidime aqueous solution to precipitate, filtering to remove precipitates, continuously using the sodium hydroxide solution to adjust the pH of obtained filtrate, and finally carrying out vacuum drying to precipitate crystals to obtain purified ceftazidime; in the determination method, the ceftazidime pentahydrate is purified by using the purification equipment, the automation degree of the purification equipment is high, and the work efficiency of purifying the ceftazidime pentahydrate is effectively improved.
Description
Technical Field
The invention relates to the field of ceftazidime, and in particular relates to a method for determining a ceftazidime polymer for injection.
Background
Ceftazidime is a third-generation cephalosporin antibiotic, has strong antibacterial activity and wide antibacterial spectrum, and has strong effect on gram positive bacteria or gram negative bacteria. Has high stability to beta-lactamase produced by gram positive bacteria and gram negative bacteria, and has strong antibacterial activity to pseudomonas aeruginosa, escherichia coli, klebsiella, proteus, enterococcus, salmonella, shigella, neisseria gonorrhoeae, neisseria meningitidis, staphylococcus aureus, hemolytic streptococcus, pneumococcus, aerobacter and the like. Ceftazidime is suitable for preventing and treating respiratory tract infection, urinary tract infection, skin and soft tissue infection, gastrointestinal infection, biliary tract infection and abdominal infection, bone and joint infection, infection complicated by dialysis and infection of various operations caused by sensitive bacteria, septicemia, bacteremia, peritonitis, meningitis, infection of immunosuppressed patients and infectious burn.
However, ceftazidime for injection is easy to generate self-polymerization reaction to generate polymer impurities so as to induce anaphylactic reaction, threatens the medication safety of people, and therefore, the content of the polymer needs to be strictly controlled.
In order to ensure the safety of the drug for human body, the national pharmacopoeia stipulates that the content of ceftazidime is not less than 95% and the content of polymer is not more than 0.3% for ceftazidime antibiotic, so that the problem to be solved by the invention is how to improve the content of ceftazidime and simultaneously greatly reduce the content of polymer and accurately detect the ceftazidime.
Disclosure of Invention
In order to overcome the technical problems, the invention aims to provide a method for determining ceftazidime polymer for injection, which comprises the following steps: deionized water is injected into a water storage tank of a purifying device, concentrated hydrochloric acid is added into an acid liquor chamber, sodium hydroxide solution is added into an alkali liquor chamber, a sealing cover is closed, a stretching cylinder is started, a movable rod of the stretching cylinder extends to push a filter plate to move downwards until the filter plate is attached to the bottom of an inner cavity of the purifying box, ceftazidime pentahydrate is added into the inner cavity of the purifying box from a feed inlet, a liquid conveying pump is started, the liquid conveying pump is operated to pump out the deionized water in the water storage tank and convey the deionized water into the inner cavity of the purifying box through a conveying pipe, the ceftazidime pentahydrate is suspended in the deionized water to obtain ceftazidime suspension, a driving motor is started, the driving motor is operated to drive a stirring blade to rotate through a rotating main shaft and a connecting rod, the rotating stirring blade stirs the ceftazidime suspension, a liquid adding pipe in acid is opened, enabling ceftazidime suspension to become clear to obtain a ceftazidime solution, opening a liquid adding pipe in an alkali liquor chamber, dropwise adding a sodium hydroxide solution into a purification box until the pH value of the ceftazidime solution is adjusted to be 1.5, separating out white-like precipitates, starting a stretching air cylinder, enabling a movable rod of the stretching air cylinder to contract to pull a filter plate to move upwards, simultaneously carrying the precipitates to move upwards, then continuously dropwise adding the sodium hydroxide solution until the pH value of the ceftazidime solution is adjusted to be 4.8, starting to separate out crystals to obtain the ceftazidime purification solution, starting a vacuum pump, operating the vacuum pump to vacuumize an inner cavity of the purification box to carry out vacuum drying on the ceftazidime purification solution, starting an air delivery pump, operating the air delivery pump to pump steam generated in the vacuum drying process through a steam pipe, delivering the steam to a plate-type condenser through a condensation inlet pipe to be condensed into a liquid state, discharging the liquid state, all crystals are separated out at the bottom of the purification box, purified ceftazidime is obtained, a discharge motor is started, the discharge motor runs to drive a linkage shaft to rotate, a supporting plate is driven to overturn through a connecting arm, the striker plate is moved away from the bottom of the purification box, the purified ceftazidime falls into a discharge groove, the ceftazidime is discharged and collected from the end part of the discharge groove, the contents of the ceftazidime and polymers in the purified ceftazidime are detected through a high performance liquid chromatography method, and the problems that the content of the ceftazidime in the existing ceftazidime antibiotics is low and the content of the polymers is high are solved.
The purpose of the invention can be realized by the following technical scheme:
a method for measuring ceftazidime polymer for injection comprises the following steps:
the method comprises the following steps: injecting deionized water into a water storage tank of the purification equipment, adding concentrated hydrochloric acid into an acid solution chamber, adding a sodium hydroxide solution into an alkali solution chamber, and closing a sealing cover;
step two: starting a stretching cylinder, wherein a movable rod of the stretching cylinder extends to push a filter plate to move downwards until the filter plate is attached to the bottom of an inner cavity of a purification box, adding the ceftazidime pentahydrate into the inner cavity of the purification box from a feeding port, starting a liquid conveying pump, and operating the liquid conveying pump to pump deionized water in a water storage box out and convey the deionized water to the inner cavity of the purification box through a conveying pipe, so that the ceftazidime pentahydrate is suspended in the deionized water to obtain a ceftazidime suspension liquid;
step three: starting a driving motor, driving the stirring blades to rotate by rotating a main shaft and a connecting rod, stirring the ceftazidime suspension by the rotating stirring blades, opening a liquid adding pipe in an acid liquid chamber, and dropwise adding concentrated hydrochloric acid into a purification box until the ceftazidime pentahydrate is completely dissolved, so that the ceftazidime suspension becomes clear, and obtaining a ceftazidime solution;
step four: opening a liquid adding pipe in an alkali liquid chamber, dropwise adding a sodium hydroxide solution into a purification box until the pH of the ceftazidime solution is adjusted to be 1.5, separating out a white-like precipitate, starting a stretching cylinder, drawing a filter plate to move upwards by contraction of a movable rod of the stretching cylinder, carrying the precipitate to move upwards, then continuously dropwise adding the sodium hydroxide solution until the pH of the ceftazidime solution is adjusted to be 4.8, and beginning to separate out crystals to obtain the ceftazidime purification solution;
step five: starting a vacuum pump, operating the vacuum pump to vacuumize the inner cavity of the purification box to carry out vacuum drying on the ceftazidime purification solution, starting a gas delivery pump, operating the gas delivery pump to pump out steam generated in the vacuum drying process through a steam pipe, delivering the steam to a plate-type condenser through a condensation inlet pipe to be condensed into a liquid state, and discharging the liquid state from a condensation outlet pipe, and separating out all crystals at the bottom of the purification box after deionized water in the ceftazidime purification solution is completely evaporated to dryness to obtain purified ceftazidime;
step six: starting a material discharging motor, driving a linkage shaft to rotate by the operation of the material discharging motor, driving a supporting plate to turn over through a connecting arm, moving a material baffle plate away from the bottom of a purifying box, discharging purified ceftazidime into a material discharging groove, and discharging and collecting the purified ceftazidime from the end part of the material discharging groove;
step seven: and detecting the contents of ceftazidime and the polymer in the purified ceftazidime by using a high performance liquid chromatography.
As a further scheme of the invention: the concentrated hydrochloric acid is 37% in mass fraction, and the sodium hydroxide solution is a sodium hydroxide solution with the mass concentration of 2 mol/L.
As a further scheme of the invention: the purification equipment comprises an installation frame, a water storage tank, a liquid conveying pump, a vacuum pumping pump, a plate-type condenser, a first installation plate, a gas conveying pump, a purification box, a discharge groove, an adjustment box, a charging opening, a second installation plate, a driving motor and a discharge motor, wherein the water storage tank and the vacuum pumping pump are respectively installed at two ends of the bottom of an inner cavity of the installation frame, the installation frame is sequentially provided with the liquid conveying pump and the plate-type condenser between the water storage tank and the vacuum pumping pump, the first installation plate is installed at the bottom of one side of the installation frame, the gas conveying pump is installed at the top of the first installation plate, the purification box is installed at the top of the installation frame, the discharge groove is installed at the bottom of the purification box, the charging opening is arranged at the middle position of the top of the purification box, the adjustment, driving motor is installed at the top of second mounting panel, the blowing motor is installed at the opposite side top of installation frame.
As a further scheme of the invention: the bottom of one side of water storage box communicates to the input port of transport liquid pump through the pipeline, the conveyer pipe is installed to the delivery outlet of transport liquid pump, the top of conveyer pipe communicates to the top of purification case, install the exhaust tube on the input port of evacuation pump, the top of exhaust tube communicates to the top of purification case, the one end that the mediation case was kept away from at the top of purification case is installed the steam pipe, the bottom of steam pipe communicates to the input port of transport gas pump, the condensation inlet pipe is installed to the output port of transport gas pump, the one end that the condensation inlet pipe kept away from transport gas pump communicates to the input port of plate condenser, install the condensation exit tube on the output port of plate condenser.
As a further scheme of the invention: rotate in the inner chamber of purification case and install the rotation main shaft, the one end that rotates the main shaft runs through the one end of purification case and extends to driving motor on the output shaft, rotate the main shaft on the equidistance install a plurality of installation splint, a plurality of all install the connecting rod on the installation splint, it is adjacent mutually perpendicular sets up, a plurality of between the connecting rod the one end that installation splint were kept away from to the connecting rod all installs the stirring leaf.
As a further scheme of the invention: two stretching cylinders are installed at the two ends of the top of the purification box, the two stretching cylinders at the same end are located on the two sides of the rotating main shaft respectively, the output shafts of the stretching cylinders are connected to four corners of the top of the filter plate respectively, and the filter screen is installed on the filter plate.
As a further scheme of the invention: the discharge gate has been seted up to the bottom of purification case, the striker plate is installed in the embedding on the discharge gate, the top in the backup pad is installed to the striker plate, the connecting plate is all installed, two at the both ends of backup pad the connecting plate is installed respectively at the bottom both ends of purification case and is located the inner chamber of row material groove, a plurality of linking arm, a plurality of are installed to bottom one side equidistance of backup pad, a plurality of the one end that the backup pad was kept away from to the linking arm is all fixed cup joints on the universal driving shaft, the universal driving shaft rotates and installs on two connecting plates, the one end of universal driving shaft runs through one of them.
As a further scheme of the invention: the top hinged joint of mediation case has sealed lid, the division board is vertically installed in the inner chamber middle part of mediation case, the combination forms sour liquid chamber, alkali lye room between the inner chamber of mediation case and the division board, the liquid feeding pipe is all installed to the bottom in sour liquid chamber, alkali lye chamber, two the bottom of liquid feeding pipe all is located the inner chamber of purification case, be provided with the metering valve on the liquid feeding pipe.
The invention has the beneficial effects that:
the invention relates to a method for determining ceftazidime polymer for injection, which comprises the steps of injecting deionized water into a water storage tank of a purifying device, adding concentrated hydrochloric acid into an acid solution chamber, adding sodium hydroxide solution into an alkali solution chamber, closing a sealing cover, starting a stretching cylinder, extending a movable rod of the stretching cylinder to push a filter plate to move downwards until the filter plate is attached to the bottom of an inner cavity of the purifying tank, adding ceftazidime pentahydrate into the inner cavity of the purifying tank from a feed inlet, starting a liquid conveying pump, pumping the deionized water in the water storage tank out by the operation of the liquid conveying pump, conveying the deionized water into the inner cavity of the purifying tank through a conveying pipe, suspending the ceftazidime pentahydrate in the deionized water to obtain ceftazidime suspension, starting a driving motor, driving a stirring blade to rotate by the operation of the driving motor through a rotating main shaft and a connecting rod, stirring the rotating stirring blade stirring the ceftazidime suspension, opening a liquid feeding pipe in an acid, enabling ceftazidime suspension to become clear to obtain a ceftazidime solution, opening a liquid adding pipe in an alkali liquor chamber, dropwise adding a sodium hydroxide solution into a purification box until the pH value of the ceftazidime solution is adjusted to be 1.5, separating out white-like precipitates, starting a stretching air cylinder, enabling a movable rod of the stretching air cylinder to contract to pull a filter plate to move upwards, simultaneously carrying the precipitates to move upwards, then continuously dropwise adding the sodium hydroxide solution until the pH value of the ceftazidime solution is adjusted to be 4.8, starting to separate out crystals to obtain the ceftazidime purification solution, starting a vacuum pump, operating the vacuum pump to vacuumize an inner cavity of the purification box to carry out vacuum drying on the ceftazidime purification solution, starting an air delivery pump, operating the air delivery pump to pump steam generated in the vacuum drying process through a steam pipe, delivering the steam to a plate-type condenser through a condensation inlet pipe to be condensed into a liquid state, discharging the liquid state, separating out all crystals at the bottom of the purification box to obtain purified ceftazidime, starting a discharge motor, operating the discharge motor to drive a linkage shaft to rotate, driving a supporting plate to turn over through a connecting arm, moving a baffle plate away from the bottom of the purification box, discharging and collecting the purified ceftazidime from the end part of a discharge groove, and detecting the contents of the ceftazidime and polymers in the purified ceftazidime by using a high performance liquid chromatography;
in the determination method, concentrated hydrochloric acid is added into ceftazidime pentahydrate water to dissolve the ceftazidime pentahydrate water, then sodium hydroxide solution is added to adjust the pH of the ceftazidime pentahydrate water solution to precipitate, the precipitate is removed by filtration, the obtained filtrate is continuously adjusted by the sodium hydroxide solution, finally, crystals are separated by vacuum drying, and purified ceftazidime is obtained;
in the determination method, the ceftazidime pentahydrate is purified by using the purification equipment, the automation degree of the purification equipment is high, and the work efficiency of purifying the ceftazidime pentahydrate is effectively improved.
Drawings
The invention will be further described with reference to the accompanying drawings.
FIG. 1 is a schematic view of the structure of a purification apparatus according to the present invention;
FIG. 2 is a schematic view showing the internal structure of the purification tank of the present invention;
FIG. 3 is a connection view of the driving motor, the rotating main shaft and the stirring blade in the present invention;
FIG. 4 is a connecting view of a discharge motor, a linkage shaft and a striker plate in the invention;
FIG. 5 is a schematic diagram of the internal structure of the mediation box of the present invention;
FIG. 6 is a schematic view of the structure of the filter plate of the present invention.
In the figure: 101. a mounting frame; 102. a water storage tank; 103. a liquid conveying pump; 104. a vacuum pump is pumped; 105. a plate condenser; 106. a first mounting plate; 107. a gas delivery pump; 108. a purification box; 109. a discharge chute; 110. a mediation box; 111. a feed inlet; 112. a second mounting plate; 113. a drive motor; 114. a discharging motor; 115. a striker plate; 116. a connecting plate; 117. rotating the main shaft; 118. a connecting rod; 119. installing a clamping plate; 120. stirring blades; 121. a linkage shaft; 122. a connecting arm; 123. a support plate; 124. a sealing cover; 125. a partition plate; 126. an acid liquid chamber; 127. an alkaline chamber; 128. a liquid feeding pipe; 129. a filter plate; 130. stretching the cylinder; 131. a filter screen; 201. an air exhaust pipe; 202. a delivery pipe; 203. a steam pipe; 204. a condensing inlet pipe; 205. and (6) condensing out a pipe.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
Example 1:
referring to fig. 1-6, the present embodiment is a method for determining ceftazidime polymer for injection, comprising the following steps:
the method comprises the following steps: injecting deionized water into the water storage tank 102 of the purification equipment, adding concentrated hydrochloric acid into the acid liquor chamber 126, adding sodium hydroxide solution into the alkali liquor chamber 127, and closing the sealing cover 124;
step two: starting the stretching cylinder 130, enabling a movable rod of the stretching cylinder 130 to extend to push the filter plate 129 to move downwards until the filter plate is attached to the bottom of the inner cavity of the purification box 108, adding the ceftazidime pentahydrate into the inner cavity of the purification box 108 from the feeding port 111, starting the liquid conveying pump 103, enabling the liquid conveying pump 103 to operate to pump deionized water in the water storage box 102 out and convey the deionized water into the inner cavity of the purification box 108 through the conveying pipe 202, and enabling the ceftazidime pentahydrate to be suspended in the deionized water to obtain a ceftazidime suspension;
step three: starting the driving motor 113, driving the stirring blade 120 to rotate by the rotation of the driving motor 113 through the rotation main shaft 117 and the connecting rod 118, stirring the ceftazidime suspension by the rotating stirring blade 120, opening the liquid adding pipe 128 in the acid liquid chamber 126, and dropwise adding concentrated hydrochloric acid into the purification box 108 until the ceftazidime pentahydrate is completely dissolved, so that the ceftazidime suspension becomes clear, and a ceftazidime solution is obtained;
step four: opening a liquid adding pipe 128 in an alkali liquid chamber 127 to dropwise add a sodium hydroxide solution into the purification box 108 until the pH of the ceftazidime solution is adjusted to be 1.5, separating out a white-like precipitate, starting a stretching cylinder 130, enabling a movable rod of the stretching cylinder 130 to contract to pull a filter plate 129 to move upwards while carrying the precipitate to move upwards, and then continuously dropwise adding the sodium hydroxide solution until the pH of the ceftazidime solution is adjusted to be 4.8, and starting to separate out crystals to obtain the ceftazidime purification solution;
step five: starting a vacuum pump 104, operating the vacuum pump 104 to vacuumize the inner cavity of a purification box 108 to carry out vacuum drying on the ceftazidime purification solution, starting a gas delivery pump 107, operating the gas delivery pump 107 to pump out steam generated in the vacuum drying process through a steam pipe 203, delivering the steam to a plate type condenser 105 through a condensation inlet pipe 204 to be condensed into a liquid state, and discharging the liquid state from a condensation outlet pipe 205, and separating out all crystals at the bottom of the purification box 108 after deionized water in the ceftazidime purification solution is completely evaporated to dryness to obtain purified ceftazidime;
step six: starting the discharging motor 114, operating the discharging motor 114 to drive the linkage shaft 121 to rotate, driving the supporting plate 123 to turn over through the connecting arm 122, moving the striker plate 115 away from the bottom of the purification box 108, dropping the purified ceftazidime into the discharge groove 109, and discharging and collecting the ceftazidime from the end part of the discharge groove 109;
step seven: and detecting the contents of ceftazidime and the polymer in the purified ceftazidime by using a high performance liquid chromatography.
The concentrated hydrochloric acid is 37% in mass fraction, and the sodium hydroxide solution is a sodium hydroxide solution with the mass concentration of 2 mol/L.
Example 2:
referring to fig. 1-6, the purifying apparatus in this embodiment includes a mounting frame 101, a water storage tank 102, a liquid delivery pump 103, a vacuum pump 104, a plate condenser 105, a first mounting plate 106, a gas delivery pump 107, a purifying tank 108, a discharging tank 109, an adjusting tank 110, a feeding port 111, a second mounting plate 112, a driving motor 113, and a discharging motor 114, the water storage tank 102 and the vacuum pump 104 are respectively mounted at two ends of the bottom of an inner cavity of the mounting frame 101, the liquid delivery pump 103 and the plate condenser 105 are sequentially mounted between the water storage tank 102 and the vacuum pump 104 on the mounting frame 101, the first mounting plate 106 is mounted at the bottom of one side of the mounting frame 101, the gas delivery pump 107 is mounted at the top of the first mounting plate 106, the purifying tank 108 is mounted at the top of the mounting frame 101, the discharging tank 109 is mounted at the bottom of the purifying tank 108, the feeding port 111 is disposed, an adjusting box 110 is installed at one end of the top of the purification box 108, a second mounting plate 112 is installed at the top end of one side of the mounting frame 101, a driving motor 113 is installed at the top of the second mounting plate 112, and a discharging motor 114 is installed at the top of the other side of the mounting frame 101;
the bottom of one side of the water storage tank 102 is communicated to an input port of a liquid conveying pump 103 through a pipeline, a conveying pipe 202 is installed at an output port of the liquid conveying pump 103, the top end of the conveying pipe 202 is communicated to the top of the purification tank 108, an extraction pipe 201 is installed at an input port of the vacuum pumping pump 104, the top end of the extraction pipe 201 is communicated to the top of the purification tank 108, a steam pipe 203 is installed at one end, away from the regulation tank 110, of the top of the purification tank 108, the bottom end of the steam pipe 203 is communicated to an input port of the gas conveying pump 107, a condensation inlet pipe 204 is installed at an output port of the gas conveying pump 107, one end, away from the gas conveying pump 107, of the condensation inlet pipe 204 is communicated to an input port;
a rotating main shaft 117 is rotatably installed in the inner cavity of the purification box 108, one end of the rotating main shaft 117 penetrates through one end of the purification box 108 and extends to an output shaft of the driving motor 113, a plurality of installation clamping plates 119 are installed on the rotating main shaft 117 at equal intervals, a plurality of installation clamping plates 119 are all installed on the installation clamping plates 119, adjacent connection rods 118 are arranged in a mutually perpendicular mode, and stirring blades 120 are all installed at one ends, far away from the installation clamping plates 119, of the connection rods 118;
two stretching cylinders 130 are respectively installed at two ends of the top of the purification box 108, the two stretching cylinders 130 at the same end are respectively located at two sides of the rotating main shaft 117, output shafts of the four stretching cylinders 130 are respectively connected to four corners of the top of the filter plate 129, and the filter plate 129 is provided with a filter screen 131;
a discharge port is formed in the bottom of the purification box 108, a baffle plate 115 is embedded in the discharge port, the baffle plate 115 is installed at the top of a support plate 123, connecting plates 116 are installed at two ends of the support plate 123, the two connecting plates 116 are installed at two ends of the bottom of the purification box 108 respectively and are located in an inner cavity of the discharge groove 109, a plurality of connecting arms 122 are installed on one side of the bottom of the support plate 123 at equal intervals, one ends, far away from the support plate 123, of the connecting arms 122 are fixedly sleeved on a linkage shaft 121, the linkage shaft 121 is rotatably installed on the two connecting plates 116, and one end of the linkage shaft 121 penetrates through one of the connecting plates 116 and extends to an output shaft of the discharge motor;
the top of the adjusting box 110 is hinged with a sealing cover 124, a partition plate 125 is vertically arranged in the middle of an inner cavity of the adjusting box 110, an acid liquid chamber 126 and an alkali liquid chamber 127 are formed between the inner cavity of the adjusting box 110 and the partition plate 125 in a combined mode, liquid adding pipes 128 are arranged at the bottoms of the acid liquid chamber 126 and the alkali liquid chamber 127, the bottom ends of the two liquid adding pipes 128 are located in the inner cavity of the purifying box 108, and a metering valve is arranged on the liquid adding pipes 128.
Referring to fig. 1-6, the operation of the purification apparatus in this embodiment is as follows:
the method comprises the following steps: injecting deionized water into the water storage tank 102 of the purification equipment, adding concentrated hydrochloric acid into the acid liquor chamber 126, adding sodium hydroxide solution into the alkali liquor chamber 127, and closing the sealing cover 124;
step two: starting the stretching cylinder 130, enabling a movable rod of the stretching cylinder 130 to extend to push the filter plate 129 to move downwards until the filter plate is attached to the bottom of the inner cavity of the purification box 108, adding the ceftazidime pentahydrate into the inner cavity of the purification box 108 from the feeding port 111, starting the liquid conveying pump 103, enabling the liquid conveying pump 103 to operate to pump deionized water in the water storage box 102 out and convey the deionized water into the inner cavity of the purification box 108 through the conveying pipe 202, and enabling the ceftazidime pentahydrate to be suspended in the deionized water to obtain a ceftazidime suspension;
step three: starting the driving motor 113, driving the stirring blade 120 to rotate by the rotation of the driving motor 113 through the rotation main shaft 117 and the connecting rod 118, stirring the ceftazidime suspension by the rotating stirring blade 120, opening the liquid adding pipe 128 in the acid liquid chamber 126, and dropwise adding concentrated hydrochloric acid into the purification box 108 until the ceftazidime pentahydrate is completely dissolved, so that the ceftazidime suspension becomes clear, and a ceftazidime solution is obtained;
step four: opening a liquid adding pipe 128 in an alkali liquid chamber 127 to dropwise add a sodium hydroxide solution into the purification box 108 until the pH of the ceftazidime solution is adjusted to be 1.5, separating out a white-like precipitate, starting a stretching cylinder 130, enabling a movable rod of the stretching cylinder 130 to contract to pull a filter plate 129 to move upwards while carrying the precipitate to move upwards, and then continuously dropwise adding the sodium hydroxide solution until the pH of the ceftazidime solution is adjusted to be 4.8, and starting to separate out crystals to obtain the ceftazidime purification solution;
step five: starting a vacuum pump 104, operating the vacuum pump 104 to vacuumize the inner cavity of a purification box 108 to carry out vacuum drying on the ceftazidime purification solution, starting a gas delivery pump 107, operating the gas delivery pump 107 to pump out steam generated in the vacuum drying process through a steam pipe 203, delivering the steam to a plate type condenser 105 through a condensation inlet pipe 204 to be condensed into a liquid state, and discharging the liquid state from a condensation outlet pipe 205, and separating out all crystals at the bottom of the purification box 108 after deionized water in the ceftazidime purification solution is completely evaporated to dryness to obtain purified ceftazidime;
step six: starting the discharging motor 114, operating the discharging motor 114 to drive the linkage shaft 121 to rotate, driving the supporting plate 123 to turn over through the connecting arm 122, moving the striker plate 115 away from the bottom of the purification box 108, dropping the purified ceftazidime into the discharge groove 109, and discharging and collecting the ceftazidime from the end part of the discharge groove 109;
step seven: and detecting the contents of ceftazidime and the polymer in the purified ceftazidime by using a high performance liquid chromatography.
And (3) detection results:
the contents of ceftazidime and the polymer in the ceftazidime pentahydrate and the purified ceftazidime are detected by using a high performance liquid chromatography, and the detection results are shown in the following table:
| sample (I) | Ceftazidime content (%) | Polymer content (%) |
| Ceftazidime pentahydrate | 90.3 | 8.6 |
| Purified ceftazidime | 99.1 | 0.06 |
In the description herein, references to the description of "one embodiment," "an example," "a specific example" or the like are intended to mean that a particular feature, structure, material, or characteristic described in connection with the embodiment or example is included in at least one embodiment or example of the invention. In this specification, the schematic representations of the terms used above do not necessarily refer to the same embodiment or example. Furthermore, the particular features, structures, materials, or characteristics described may be combined in any suitable manner in any one or more embodiments or examples.
The foregoing is illustrative and explanatory only and is not intended to be exhaustive or to limit the invention to the precise embodiments described, and various modifications, additions, and substitutions may be made by those skilled in the art without departing from the scope of the invention or exceeding the scope of the claims.
Claims (8)
1. The method for measuring the ceftazidime polymer for injection is characterized by comprising the following steps of:
the method comprises the following steps: injecting deionized water into a water storage tank (102) of the purification equipment, adding concentrated hydrochloric acid into an acid liquid chamber (126), adding a sodium hydroxide solution into an alkali liquid chamber (127), and closing a sealing cover (124);
step two: starting a stretching cylinder (130), wherein a movable rod of the stretching cylinder (130) extends to push a filter plate (129) to move downwards until the filter plate is attached to the bottom of an inner cavity of a purification box (108), ceftazidime pentahydrate is added into the inner cavity of the purification box (108) from a feed port (111), a liquid conveying pump (103) is started, the liquid conveying pump (103) operates to pump deionized water in a water storage box (102) out and convey the deionized water into the inner cavity of the purification box (108) through a conveying pipe (202), so that the ceftazidime pentahydrate is suspended in the deionized water, and a ceftazidime suspension is obtained;
step three: starting a driving motor (113), driving the stirring blade (120) to rotate by the operation of the driving motor (113) through a rotating main shaft (117) and a connecting rod (118), stirring the ceftazidime suspension liquid by the rotating stirring blade (120), opening a liquid adding pipe (128) in an acid liquid chamber (126), and dropwise adding concentrated hydrochloric acid into a purification box (108) until the ceftazidime pentahydrate is completely dissolved, so that the ceftazidime suspension liquid is clarified to obtain a ceftazidime solution;
step four: opening a liquid adding pipe (128) in an alkali liquid chamber (127) and dropwise adding a sodium hydroxide solution into a purification box (108) until the pH of the ceftazidime solution is adjusted to be 1.5, separating out a white-like precipitate, starting a stretching cylinder (130), drawing a filter plate (129) to move upwards by contraction of a movable rod of the stretching cylinder (130), carrying the precipitate to move upwards, and then continuously dropwise adding the sodium hydroxide solution until the pH of the ceftazidime solution is adjusted to be 4.8, and starting to separate out crystals to obtain the ceftazidime purification solution;
step five: starting a vacuum pumping pump (104), operating the vacuum pumping pump (104) to vacuumize an inner cavity of a purification box (108) to carry out vacuum drying on the ceftazidime purification solution, starting a gas delivery pump (107), operating the gas delivery pump (107) to pump out steam generated in the vacuum drying process through a steam pipe (203), conveying the steam to a plate-type condenser (105) through a condensation inlet pipe (204) to be condensed into a liquid state, and discharging the liquid state from a condensation outlet pipe (205), and separating out all crystals at the bottom of the purification box (108) after deionized water in the ceftazidime purification solution is completely evaporated to dryness to obtain purified ceftazidime;
step six: starting a feeding motor (114), operating the feeding motor (114) to drive a linkage shaft (121) to rotate, driving a supporting plate (123) to turn over through a connecting arm (122), moving a material baffle (115) away from the bottom of a purification box (108), dropping purified ceftazidime into a discharge groove (109), and discharging and collecting the ceftazidime from the end part of the discharge groove (109);
step seven: and detecting the contents of ceftazidime and the polymer in the purified ceftazidime by using a high performance liquid chromatography.
2. A method for determining ceftazidime polymer for injection as claimed in claim 1, wherein the concentrated hydrochloric acid is 37% by weight, and the sodium hydroxide solution is a sodium hydroxide solution with a substance concentration of 2 mol/L.
3. The ceftazidime polymer measuring method for injection according to claim 1, wherein the purifying device comprises a mounting frame (101), a water storage tank (102), a liquid conveying pump (103), a vacuum pumping pump (104), a plate-type condenser (105), a first mounting plate (106), a conveying air pump (107), a purifying tank (108), a discharge tank (109), an adjusting tank (110), a feeding port (111), a second mounting plate (112), a driving motor (113) and a discharging motor (114), the water storage tank (102) and the vacuum pumping pump (104) are respectively mounted at two ends of the bottom of the inner cavity of the mounting frame (101), the liquid conveying pump (103) and the plate-type condenser (105) are sequentially mounted between the water storage tank (102) and the vacuum pumping pump (104) on the mounting frame (101), the first mounting plate (106) is mounted at the bottom of one side of the mounting frame (101), air feed pump (107) are installed at the top of first mounting panel (106), purification case (108) are installed at the top of installation frame (101), row material tank (109) are installed to the bottom of purification case (108), the top intermediate position of purification case (108) is provided with charge door (111), mediation case (110) is installed to the top one end of purification case (108), second mounting panel (112) are installed on one side top of installation frame (101), driving motor (113) are installed at the top of second mounting panel (112), blowing motor (114) are installed at the opposite side top of installation frame (101).
4. The ceftazidime polymer measuring method for injection as claimed in claim 3, wherein the bottom of one side of the water storage tank (102) is connected to the input port of the liquid delivery pump (103) through a pipeline, the output port of the liquid delivery pump (103) is provided with a delivery pipe (202), the top end of the delivery pipe (202) is connected to the top of the purification tank (108), the input port of the vacuum pump (104) is provided with an air suction pipe (201), the top end of the air suction pipe (201) is connected to the top of the purification tank (108), the end of the top of the purification tank (108) far away from the regulating tank (110) is provided with a steam pipe (203), the bottom end of the steam pipe (203) is connected to the input port of the air delivery pump (107), the output port of the air delivery pump (107) is provided with a condensation pipe (204), and the end of the condensation pipe (204) far away from the air delivery pump (107) is connected to the input, and a condensation outlet pipe (205) is installed on the output port of the plate condenser (105).
5. The method for determining ceftazidime polymer for injection according to claim 3, wherein a rotating main shaft (117) is rotatably installed in the inner cavity of the purifying box (108), one end of the rotating main shaft (117) penetrates through one end of the purifying box (108) and extends to the output shaft of the driving motor (113), a plurality of installation clamping plates (119) are installed on the rotating main shaft (117) at equal intervals, connecting rods (118) are installed on the installation clamping plates (119), the adjacent connecting rods (118) are perpendicular to each other, and stirring blades (120) are installed at one ends, far away from the installation clamping plates (119), of the connecting rods (118).
6. A ceftazidime polymer assay method for injection according to claim 3, wherein two stretching cylinders (130) are installed at both ends of the top of the purification box (108), the two stretching cylinders (130) at the same end are respectively located at both sides of the main rotating shaft (117), the output shafts of the four stretching cylinders (130) are respectively connected to the four corners of the top of the filter plate (129), and the filter plate (129) is installed with a filter screen (131).
7. A method for assaying ceftazidime polymer for injection according to claim 3, a discharge hole is formed at the bottom of the purification box (108), a material baffle plate (115) is embedded and installed on the discharge hole, the material baffle plate (115) is arranged at the top of the support plate (123), the two ends of the support plate (123) are respectively provided with the connecting plates (116), the two connecting plates (116) are respectively arranged at the two ends of the bottom of the purification box (108) and are positioned in the inner cavity of the discharge groove (109), a plurality of connecting arms (122) are equidistantly arranged on one side of the bottom of the supporting plate (123), one ends of the connecting arms (122) far away from the supporting plate (123) are fixedly sleeved on the universal driving shaft (121), the linkage shaft (121) is rotatably installed on the two connecting plates (116), and one end of the linkage shaft (121) penetrates through one of the connecting plates (116) and extends to an output shaft of the discharging motor (114).
8. The method for determining ceftazidime polymer for injection according to claim 3, wherein a sealing cover (124) is hinged to the top of the regulating box (110), a partition plate (125) is vertically installed in the middle of the inner cavity of the regulating box (110), an acid liquid chamber (126) and an alkali liquid chamber (127) are formed between the inner cavity of the regulating box (110) and the partition plate (125) in a combined manner, liquid feeding pipes (128) are installed at the bottoms of the acid liquid chamber (126) and the alkali liquid chamber (127), the bottom ends of the two liquid feeding pipes (128) are located in the inner cavity of the purifying box (108), and a metering valve is arranged on each liquid feeding pipe (128).
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