CN110870849A - Sulfamonomethoxine sodium injection and preparation method and preparation system thereof - Google Patents
Sulfamonomethoxine sodium injection and preparation method and preparation system thereof Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/63—Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide
- A61K31/635—Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide having a heterocyclic ring, e.g. sulfadiazine
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
Abstract
The invention provides a sulfamonomethoxine sodium injection and a preparation method and a system thereof. The preparation method comprises the following steps: mixing sulfamonomethoxine sodium, a stabilizer, sodium thiosulfate, ethylene diamine tetraacetic acid and water to obtain a first solution, a second solution and a third solution; mixing the first solution, the second solution and the third solution to obtain a mixed solution; mixing the mixed solution with water to bring the volume to a predetermined volume; adjusting the pH value of the mixed solution; filtering; and mixing the filtered mixed solution with water to obtain the sulfamonomethoxine sodium injection. The injection comprises the solution prepared by the method. The preparation system comprises an injection water unit, a pH adjusting unit, a liquid preparation unit, a mixing unit, a first filtering unit, a volume adjusting unit, a second filtering unit and a liquid storage unit which are sequentially arranged. The beneficial effects of the invention include: the method is simple, the injection has good stability, the solution color is not easily affected by the environment, the treatment effect is good, and the product preparation efficiency is high.
Description
Technical Field
The invention relates to the field of veterinary medicines, and particularly relates to a sulfamonomethoxine sodium injection and a preparation method and a preparation system thereof.
Background
The sulfamonomethoxine sodium belongs to sulfonamides and synthesizes antibacterial drugs, has strong inhibition effect on most gram-positive bacteria and gram-negative bacteria, and has the advantages of difficult deterioration, convenient use and the like. The sulfamonomethoxine sodium can be mainly used for respiratory tract infection, digestive tract infection and urinary tract infection caused by sensitive bacteria, coccidiosis, swine toxoplasmosis and the like. At present, the sulfamonomethoxine sodium injection has some defects, such as unstable properties, such as easy discoloration, easy crystallization and the like.
Disclosure of Invention
In view of the deficiencies in the prior art, it is an object of the present invention to address one or more of the problems in the prior art as set forth above. For example, one of the objects of the present invention is to provide an sulfamonomethoxine sodium injection with stable efficacy and less discoloration, and a preparation method and a preparation system thereof.
In order to achieve the above purpose, the invention provides a preparation method of sulfamonomethoxine sodium injection on one hand.
The preparation method can comprise the following steps: mixing 27-33 parts by weight of sulfamonomethoxine sodium, 15-20 parts by weight of a stabilizer and a first volume of water to obtain a first solution; mixing 0.2-0.3 part by weight of sodium thiosulfate with a second volume of water to obtain a second solution; mixing 0.03-0.1 part by weight of disodium ethylene diamine tetraacetate with a third part by volume of water to obtain a third solution; wherein the sum of the volumes of the first, second and third solutions is not more than a first predetermined value, and the ratio of 1 part by weight to 1 part by volume is 1 kg/L; mixing the first solution, the second solution and the third solution to obtain a mixed solution; under the condition that the volume part of the mixed solution is smaller than a first preset value, mixing the mixed solution with a water body to adjust the volume part of the mixed solution to the first preset value; adjusting the pH value of the mixed solution with the volume part of the first preset value to 10.5-10.8 by using a pH regulator; filtering the mixed solution after the pH value is adjusted; and mixing the filtered mixed solution with a water body to obtain the sulfamonomethoxine sodium injection with the volume portion of a second preset value.
According to an exemplary embodiment of the method for preparing the sulfamonomethoxine sodium injection, the first volume part may be 30-40, for example 36.
According to an exemplary embodiment of the preparation method of the sulfamonomethoxine sodium injection, the preparation method may further include the steps of: and detecting whether the content and the pH value of the components in the obtained sulfamonomethoxine sodium injection reach a preset range or not, and introducing nitrogen for protection under the condition that the content and the pH value reach the preset range.
According to an exemplary embodiment of the preparation method of the sulfamonomethoxine sodium injection, the preparation method may further include the steps of: filtering the obtained sulfamonomethoxine sodium injection by adopting a microfiltration filter element with the filtering precision of 0.20-0.5 mu m; and encapsulating the obtained filtrate.
According to an exemplary embodiment of the method for preparing the sulfamonomethoxine sodium injection, the pH adjusting agent may include a hydrochloric acid solution or a sodium hydroxide solution. For example, a 5-15% sodium hydroxide solution.
According to an exemplary embodiment of the method for preparing sulfamonomethoxine sodium injection, the stabilizer includes at least one of propylene glycol, glycerol, ethanol, and glycerol formal.
According to an exemplary embodiment of the method for preparing sulfamonomethoxine sodium injection, the second predetermined value may be 96-110.
The invention also provides a sulfamonomethoxine sodium injection.
The sulfamonomethoxine sodium injection comprises the following components in percentage by mass of 27-33: 15-20: 0.2-0.3: 0.03-0.1 parts of sulfamonomethoxine sodium, a stabilizer, sodium thiosulfate and ethylene diamine tetraacetic acid disodium.
The sulfamonomethoxine sodium injection can also comprise an injection prepared by the method.
The invention also provides a preparation system of the sulfamonomethoxine sodium injection.
The preparation system comprises: the device comprises an injection water unit, a pH adjusting unit, a liquid preparation unit, a mixing unit, a first filtering unit, a volume adjusting unit, a second filtering unit and a liquid storage unit, wherein the liquid preparation unit, the mixing unit, the first filtering unit, the volume adjusting unit, the second filtering unit and the liquid storage unit are sequentially arranged in the flowing direction of a fluid; the second liquid preparation tank can mix sodium thiosulfate with the water body to obtain a second solution; the third liquid preparation tank can mix the disodium ethylene diamine tetraacetate with the water body to obtain a third solution; the mixing unit comprises a mixing tank, wherein a stirrer is arranged in a tank body, and the mixing tank is respectively connected with the first solution preparation tank, the second solution preparation tank and the third solution preparation tank so as to receive the first solution, the second solution and the third solution and uniformly mix the first solution, the second solution and the third solution to obtain a mixed solution; the injection water unit is connected with the mixing tank, and can add water into the mixing tank under the condition that the volume of the mixed solution is smaller than a first preset volume, so that the volume of the mixed solution reaches the first preset volume; the pH adjusting unit is connected with the mixing tank, and can inject a pH adjusting agent into the mixing tank under the condition that the volume of the mixed solution reaches a first preset volume so as to enable the pH value of the mixed solution to reach a preset value; the first filtering unit can filter the mixed solution after the pH value is adjusted; the volume adjusting unit comprises a volume tank, the volume tank is respectively connected with the first filtering unit and the injection water unit, the volume tank can receive the filtered mixed solution and measure the volume of the solution, and the injection water unit can inject water into the volume tank under the condition that the volume is smaller than a second preset volume so as to enable the volume to reach the second preset volume; the second filtering unit can circularly filter the mixed solution reaching a second preset volume to obtain the sulfamonomethoxine sodium injection; the liquid storage unit can store the obtained sulfamonomethoxine sodium injection.
According to an exemplary embodiment of a preparation system of the sulfamonomethoxine sodium injection, the mass ratio of the sulfamonomethoxine sodium, the stabilizer, the sodium thiosulfate and the disodium ethylene diamine tetraacetate can be 27-33: 15-20: 0.2-0.3: 0.03 to 0.1.
According to an exemplary embodiment of the system for preparing sulfamonomethoxine sodium injection, the system may further comprise a stabilizer storage unit connected to the volume tank, the stabilizer storage unit being capable of adding a stabilizer to the volume tank in case the content of the stabilizer in the volume tank is less than a predetermined value.
According to an exemplary embodiment of the preparation system of the sulfamonomethoxine sodium injection, the second filtering unit can comprise a microfiltration filter element with the filtering precision of 0.20-0.5 μm.
Compared with the prior art, the beneficial effects of the invention can include: the preparation method is simple; the injection has good stability, the color of the solution is not easily influenced by the environment, no crystal is separated out, the injection is safe and effective, and the treatment effect is good; the sealing performance of the preparation system is good, and the influence of bacteria in the environment can be avoided.
Drawings
The above and other objects and features of the present invention will become more apparent from the following description taken in conjunction with the accompanying drawings, in which:
FIG. 1 is a schematic flow chart of the preparation method of sulfamonomethoxine sodium injection of the invention;
FIG. 2 is another schematic flow chart of the preparation method of sulfamonomethoxine sodium injection of the invention;
FIG. 3 is a schematic diagram of a system for preparing sulfamonomethoxine sodium injection according to the present invention;
fig. 4 shows another schematic diagram of the preparation system of sulfamonomethoxine sodium injection of the invention.
Detailed Description
Hereinafter, the sulfamonomethoxine sodium injection and the preparation method and system thereof will be described in detail with reference to the accompanying drawings and exemplary embodiments.
The invention provides a preparation method of sulfamonomethoxine sodium injection on the one hand.
Fig. 1 shows a flow diagram of a preparation method of sulfamonomethoxine sodium injection of the invention. Fig. 2 shows another flow chart of the preparation method of the sulfamonomethoxine sodium injection of the invention.
In an exemplary embodiment of the preparation method of sulfamonomethoxine sodium injection of the present invention, as shown in fig. 1, the preparation method may include the following steps:
s01: mixing sulfamonomethoxine sodium, a stabilizer and a water body to obtain a first solution; mixing sodium thiosulfate with a water body to obtain a second solution; and mixing the disodium ethylene diamine tetraacetate with the water body to obtain a third solution. Specifically, it may be:
27-33 parts by weight of sulfamonomethoxine sodium, 15-20 parts by weight of a stabilizer and a first volume of water are mixed to obtain a first solution. And mixing 0.2-0.3 part by weight of sodium thiosulfate with a second volume of water to obtain a second solution. And mixing 0.03-0.1 part by weight of disodium ethylene diamine tetraacetate with a third volume part of water to obtain a third solution. Wherein, in the first solution, the sulfamonomethoxine sodium is fully dissolved, in the second solution, the sodium thiosulfate is fully dissolved, and in the third solution, the ethylene diamine tetraacetic acid disodium is fully dissolved; the sum of the volumes of the first, second and third solutions is not greater than a first predetermined value, and the sum of the volume fractions of the first, second and third solutions is less than the first predetermined value. The first volume fraction may be 40 or less. The ratio of 1 part by weight to 1 part by volume was 1 kg/L. In the invention, the weight parts are used for expressing the weight size relation among corresponding substances and do not refer to specific weight units; the volume fraction is used to indicate the volume size relationship between the corresponding substances, and does not refer to a specific volume unit.
S02: and mixing the first solution, the second solution and the third solution to obtain a mixed solution.
S03: water is added to the mixed solution to adjust the volume of the mixed solution to a first predetermined volume. Even if the volume part of the mixed solution is the first predetermined value. The first predetermined volume may be 90 to 95 parts by volume.
S04: and adjusting the pH value of the mixed solution after volume adjustment to a preset value by using a pH adjusting agent. Wherein the predetermined value can be 10.5-10.8. The pH regulator comprises hydrochloric acid solution or sodium hydroxide solution. The concentration of the sodium hydroxide solution may be 5-15%, for example 10%.
S05: and filtering the mixed solution after the pH value is adjusted.
S06: and mixing the filtered mixed solution with a water body to obtain the sulfamonomethoxine sodium injection with the volume portion of the second preset volume. The second predetermined volume is a second predetermined volume. The second predetermined volume may be 95 to 110 parts by volume, for example 100 parts by volume. Stirring can be carried out in the mixing process until the mixture is uniform, and the stirring time can be determined according to the actual situation, such as 15-30 min, and 20 min.
S07: the sulfamonomethoxine sodium injection is filtered again. Wherein, the filtration can include circulation filtration, and the filtration time can be 5-20 min, such as 10 min. The microfiltration filter element with the filtration precision of 0.20-0.5 mu m can be adopted for circular filtration, such as 0.22, 0.3 and 0.4 mu m microfiltration filter elements.
In this embodiment, further, the sulfamonomethoxine sodium may be 30 ± 1 parts by weight, the stabilizer may be 18 ± 1 parts by weight, the sodium thiosulfate may be 0.22 ± 0.01 parts by weight, and the disodium ethylenediaminetetraacetate may be 0.05 ± 0.01 parts by weight.
In this embodiment, the commonly used antioxidants include sodium sulfite, sodium bisulfite, sodium thiosulfate, sodium metabisulfite, etc., but not all antioxidants are applicable to the present invention, and in the preparation process of the injection of the present invention, sodium thiosulfate is selected, which can reduce the influence of illumination, temperature, etc. on the color of the solution, and is helpful for the stability of the solution form and the reduction of the change of the solution color; meanwhile, the sodium thiosulfate can also generate a synergistic effect with other substances in the invention, and the prepared injection has strong stability.
In this embodiment, the stabilizer may include at least one of propylene glycol, glycerin, ethanol, and glycerol formal. Furthermore, the invention can select propylene glycol, which can increase the stability of the medicine and solve the problem of crystallization.
In the embodiment, the disodium ethylenediamine acetate is selected as the metal complexing agent, and the disodium ethylenediamine acetate is added to remove metal ions in the injection, so that the influence of the metal ions on the drug effect of sulfamonomethoxine sodium is avoided.
In this embodiment, preferably, in the preparation process of the sulfamonomethoxine sodium injection, the sulfamonomethoxine sodium, the propylene glycol, the sodium thiosulfate and the ethylenediamine disodium acetate are combined for use, and such combination can not only solve the problems of instability, easy discoloration, easy crystallization, low drug effect and the like of a medicament, but also can effectively treat toxoplasmosis.
In this embodiment, the sum of the volumes of propylene glycol and the first volume of water may be 50 to 60.
In this embodiment, between steps S06 and S07, the preparation method may further include the steps of: detecting whether the content and the pH value of the components in the obtained sulfamonomethoxine sodium injection reach a preset range or not, and introducing nitrogen for protection under the condition that the content and the pH value reach the preset range.
In this embodiment, after step S07, the preparation method may further include a step of potting.
In this embodiment, after the potting, the preparation method may further include a sterilization step, wherein the sterilization temperature may be 105 to 110 ℃, and the time may be 30 min.
In this embodiment, the body of water comprises water for injection.
In another exemplary embodiment of the preparation method of sulfamonomethoxine sodium injection of the present invention, as shown in fig. 2, the preparation method may include the following steps:
and (3) preparing a concentrated solution by using the raw materials and the auxiliary materials. Wherein the raw material is sulfamonomethoxine sodium, and the auxiliary materials are sodium thiosulfate, ethylene diamine tetraacetic acid disodium and propylene glycol. Specifically, according to the requirement of the preset dosage, 60% of the total amount of water for injection and propylene glycol are added into a liquid preparation tank, the sulfamonomethoxine sodium is added and stirred to be completely dissolved, then a small amount of water for injection is respectively taken to dissolve the sodium thiosulfate and the ethylene diamine tetraacetic acid, and then the sodium thiosulfate and the ethylene diamine tetraacetic acid are added into the solution and mixed evenly. Adding water for injection to nearly the full amount, and adjusting the pH value to 10.5-10.8 by using 10% sodium hydroxide solution to obtain a concentrated solution (also called concentrated liquid medicine). Wherein, the total amount is the total water consumption of the injection water in the whole process.
The concentrated solution is coarsely filtered, so that foreign matters in the auxiliary materials can be removed, and the clarity is increased. For example, the concentrated solution may be filtered through a titanium rod filter to a dilution tank.
Diluting, namely adding water for injection to full volume, and stirring for 20 minutes to obtain diluted solution. Sampling, detecting the content (such as the content of sulfamonomethoxine sodium as a main drug) and the pH value, and introducing nitrogen into the diluting preparation tank for protection after the contents are qualified.
Fine filtering: this step may include: (1) before filtration, the sterilizing filter is subjected to complete inspection, and is cleaned after being qualified. (2) A filter (the precision of a filter screen can be 0.45um or 0.22um) of the filtering system, a pipeline and the like are installed. (3) And (3) circularly filtering the diluted preparation solution by using a filter for 10min, sampling at a sampling port to check visible foreign matters, and if the diluted preparation solution is qualified, delivering the diluted preparation solution to a filling and sealing station. Wherein, if the filter element needs to be replaced or the pipeline needs to be disconnected and reconnected in the filtering process, the integrity test needs to be carried out again, and the filtering can be continued after the visible foreign matters and the pH color are checked to be qualified. The filtering speed should be checked at any time during the filtering process, and if the filtering speed is too fast or too slow, the filtering system should be checked. After filtration is complete, the filter may be integrity checked again.
In this embodiment, the sulfamonomethoxine sodium can be in the specification of injection grade. The specification for sodium thiosulfate can be an analytically pure grade. The specification of disodium edetate may be of analytical grade. The propylene glycol specification may be pharmaceutical grade. The specification of the water for injection may be an injection grade.
In this embodiment, as shown in fig. 2, before the water for injection is used, a water quality clarity check may be performed.
In this example, as shown in fig. 2, a clarity check may be performed after diluting the liquid.
In this embodiment, as shown in fig. 2, after fine filtration, the solution may be inspected for visible foreign matter.
The invention also provides a sulfamonomethoxine sodium injection.
The sulfamonomethoxine sodium injection comprises the following components in percentage by mass of 27-33: 15-20: 0.2-0.3: 0.03-0.1 parts of sulfamonomethoxine sodium, a stabilizer, sodium thiosulfate and ethylene diamine tetraacetic acid disodium.
Preferably, the sulfamonomethoxine sodium injection comprises the following components in percentage by mass (30 +/-1): (18. + -.1): (0.22 ± 0.01): (0.05 ± 0.01) sulfamonomethoxine sodium, stabilizer, sodium thiosulfate and disodium ethylenediaminetetraacetate, such as 30: 18: 0.22: 0.05.
still further preferably, the sulfamonomethoxine sodium injection comprises the following components in percentage by mass (30 +/-1): (18. + -.1): (0.22 ± 0.01): (0.05 +/-0.01) of sulfamonomethoxine sodium, propylene glycol, sodium thiosulfate and ethylene diamine tetraacetic acid. According to the proportion, the prepared injection has strong stability and good effect.
The invention combines the sulfamonomethoxine sodium, the propylene glycol, the sodium thiosulfate and the ethylenediamine-disodium acetate for use, thereby not only solving the problems of unstable medicament, easy color change, easy crystallization, low medicament effect and the like, but also efficiently treating toxoplasmosis.
The sulfamonomethoxine sodium injection can also comprise an injection prepared by the preparation method.
The invention further provides a preparation system of the sulfamonomethoxine sodium injection.
Fig. 3 shows a schematic diagram of a system for preparing sulfamonomethoxine sodium injection of the invention. Fig. 4 shows another schematic diagram of the preparation system of sulfamonomethoxine sodium injection of the present invention, and arrows in fig. 3 and 4 indicate the flow direction of the fluid.
In an exemplary embodiment of the preparation system of the sulfamonomethoxine sodium injection, as shown in fig. 3, the preparation system may include an injection water unit, a pH adjusting unit, and a liquid preparation unit, a mixing unit, a first filtering unit, a volume adjusting unit, a second filtering unit, and a liquid storage unit, which are sequentially arranged along a fluid flow direction. Wherein the content of the first and second substances,
as shown in fig. 4, the liquid preparation unit includes a first liquid preparation tank, a second liquid preparation tank and a third liquid preparation tank, wherein the first liquid preparation tank can mix sulfamonomethoxine sodium and propylene glycol with a water body to obtain a first solution; the second liquid preparation tank can mix sodium thiosulfate with the water body to obtain a second solution; the third liquid preparation tank can mix the disodium ethylene diamine tetraacetate with the water body to obtain a third solution.
The mixing unit comprises a mixing tank in which a stirrer is arranged, as shown in fig. 4, the mixing tank can be respectively connected with the first, second and third liquid preparation tanks to receive the first, second and third solutions and mix the first, second and third solutions uniformly to obtain a mixed solution.
As shown in fig. 4, the water for injection unit may be connected to the mixing tank, and in case that the volume of the mixed solution is less than the first predetermined volume, the water for injection unit may add a water body to the mixing tank so that the volume of the mixed solution reaches the first predetermined volume.
As shown in fig. 4, the pH adjusting unit may be connected to the mixing tank, and may inject a pH adjusting agent into the mixing tank so that the pH value of the mixed solution reaches a predetermined value, for example, 10.5 to 10.8, when the volume of the mixed solution reaches a first predetermined volume.
The first filtering unit can filter the mixed solution after the pH value is adjusted. The first filter unit may comprise a titanium rod filter.
As shown in fig. 4, the volume adjusting unit includes a volume tank, the volume tank is respectively connected to the filtering unit and the water for injection, the volume tank can receive the filtered mixed solution and measure the volume of the solution, and the water for injection can inject water into the volume tank to make the volume reach a second predetermined volume when the volume is smaller than the second predetermined volume.
The second filtering unit can circularly filter the mixed solution reaching a second preset volume to obtain the sulfamonomethoxine sodium injection. The second filtering unit can comprise a filter, and the filter can comprise a microfiltration filter element with the filtering precision of 0.20-0.5 mu m.
The liquid storage unit can store the obtained sulfamonomethoxine sodium injection. The liquid storage unit may include a liquid storage tank.
In this embodiment, the units may be connected to each other by pipes. And regulating valves can be arranged on all the pipelines for connection.
In this embodiment, the apparatus may further include a shielding gas unit connected to the reservoir. The shielding gas unit may include a gas tank in which shielding gas, such as nitrogen, inert gas, etc., is stored. The gas storage tank and the storage tank can be connected through a pipeline, and the pipeline can be provided with an adjusting valve. The gas storage tank can introduce protective gas into the liquid storage tank.
In this embodiment, each of the adjustment valves not only can make the corresponding pipe be in a circulating or closed state, but also can adjust the flow rate of the fluid in the pipe.
In this embodiment, the sealing performance of each can is excellent, and the influence of the environment can be avoided.
In this embodiment, the ratio between various raw materials, the amount of water for injection, pH control, and the like may be the same as those in the exemplary embodiment of the preparation method of sulfamonomethoxine sodium injection.
In summary, the sulfamonomethoxine sodium injection, the preparation method and the preparation system thereof have the advantages that:
(1) the preparation method is simple and convenient, short in flow and high in effect.
(2) The injection has stable shape, little influence of the color of the solution by illumination, temperature and the like, and easy storage.
(3) The injection has strong stability and no crystal precipitation; the influence of metal ions on the drug effect of the sulfamonomethoxine sodium can be avoided; can effectively treat toxoplasmosis, and is safe and effective.
(4) The preparation system has high automation degree and good sealing performance, can well avoid the influence of bacteria in the environment, and has high product preparation efficiency.
Although the present invention has been described above in connection with exemplary embodiments, it will be apparent to those skilled in the art that various modifications and changes may be made to the exemplary embodiments of the present invention without departing from the spirit and scope of the invention as defined in the appended claims.
Claims (10)
1. A preparation method of sulfamonomethoxine sodium injection is characterized by comprising the following steps:
mixing 27-33 parts by weight of sulfamonomethoxine sodium, 15-20 parts by weight of a stabilizer and a first volume of water to obtain a first solution; mixing 0.2-0.3 part by weight of sodium thiosulfate with a second volume of water to obtain a second solution; mixing 0.03-0.1 part by weight of disodium ethylene diamine tetraacetate with a third part by volume of water to obtain a third solution; wherein the sum of the volumes of the first, second and third solutions is not more than a first predetermined value, and the ratio of 1 part by weight to 1 part by volume is 1 kg/L;
mixing the first solution, the second solution and the third solution to obtain a mixed solution;
under the condition that the volume part of the mixed solution is smaller than a first preset value, mixing the mixed solution with a water body to adjust the volume part of the mixed solution to the first preset value;
adjusting the pH value of the mixed solution with the volume part of the first preset value to 10.5-10.8 by using a pH regulator;
filtering the mixed solution after the pH value is adjusted;
and mixing the filtered mixed solution with a water body to obtain the sulfamonomethoxine sodium injection with the volume portion of a second preset value.
2. The preparation method of sulfamonomethoxine sodium injection as claimed in claim 1, wherein the preparation method further comprises the steps of:
and detecting whether the content and the pH value of the components in the obtained sulfamonomethoxine sodium injection reach a preset range or not, and introducing nitrogen for protection under the condition that the content and the pH value reach the preset range.
3. The preparation method of sulfamonomethoxine sodium injection as claimed in claim 1, wherein the preparation method further comprises the steps of:
filtering the obtained sulfamonomethoxine sodium injection by adopting a microfiltration filter element with the filtering precision of 0.20-0.5 mu m;
and encapsulating the obtained filtrate.
4. The method for preparing sulfamonomethoxine sodium injection according to claim 1, wherein the pH regulator comprises hydrochloric acid solution or sodium hydroxide solution.
5. The method for preparing sulfamonomethoxine sodium injection according to claim 1, wherein the stabilizer comprises at least one of propylene glycol, glycerol, ethanol and glycerol formal.
6. The method for preparing sulfamonomethoxine sodium injection according to claim 1, wherein the second predetermined value is 96-110.
7. The sulfamonomethoxine sodium injection is characterized by comprising the following components in percentage by mass: 15-20: 0.2-0.3: 0.03-0.1 parts of sulfamonomethoxine sodium, a stabilizer, sodium thiosulfate and ethylene diamine tetraacetic acid disodium.
8. A preparation system of sulfamonomethoxine sodium injection is characterized by comprising the following components: an injection water unit, a pH adjusting unit, a liquid preparing unit, a mixing unit, a first filtering unit, a volume adjusting unit, a second filtering unit and a liquid storing unit which are sequentially arranged along the flowing direction of a fluid, wherein,
the liquid preparation unit comprises a first liquid preparation tank, a second liquid preparation tank and a third liquid preparation tank, wherein the first liquid preparation tank can mix sulfamonomethoxine sodium, a stabilizer and a water body to obtain a first solution; the second liquid preparation tank can mix sodium thiosulfate with the water body to obtain a second solution; the third liquid preparation tank can mix the disodium ethylene diamine tetraacetate with the water body to obtain a third solution;
the mixing unit comprises a mixing tank, wherein a stirrer is arranged in a tank body, and the mixing tank is respectively connected with the first solution preparation tank, the second solution preparation tank and the third solution preparation tank so as to receive the first solution, the second solution and the third solution and uniformly mix the first solution, the second solution and the third solution to obtain a mixed solution;
the injection water unit is connected with the mixing tank, and can add water into the mixing tank under the condition that the volume of the mixed solution is smaller than a first preset volume, so that the volume of the mixed solution reaches the first preset volume;
the pH adjusting unit is connected with the mixing tank, and can inject a pH adjusting agent into the mixing tank under the condition that the volume of the mixed solution reaches a first preset volume so as to enable the pH value of the mixed solution to reach a preset value;
the first filtering unit can filter the mixed solution after the pH value is adjusted;
the volume adjusting unit comprises a volume tank, the volume tank is respectively connected with the first filtering unit and the injection water unit, the volume tank can receive the filtered mixed solution and measure the volume of the solution, and the injection water unit can inject water into the volume tank under the condition that the volume is smaller than a second preset volume so as to enable the volume to reach the second preset volume;
the second filtering unit can circularly filter the mixed solution reaching a second preset volume to obtain the sulfamonomethoxine sodium injection;
the liquid storage unit can store the obtained sulfamonomethoxine sodium injection.
9. The preparation system of sulfamonomethoxine sodium injection as claimed in claim 8, wherein the mass ratio of the sulfamonomethoxine sodium to the stabilizer to the sodium thiosulfate to the disodium ethylenediamine tetraacetate is 27-33: 15-20: 0.2-0.3: 0.03 to 0.1.
10. The system for preparing sulfamonomethoxine sodium injection according to claim 8, wherein the system further comprises a stabilizer storage unit connected to the volume tank, wherein the stabilizer storage unit is capable of adding a stabilizer to the volume tank in case that the content of the stabilizer in the volume tank is less than a predetermined value.
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Application publication date: 20200310 |