CN117205151A - Amikacin sulfate injection and preparation method thereof - Google Patents
Amikacin sulfate injection and preparation method thereof Download PDFInfo
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- CN117205151A CN117205151A CN202311429430.0A CN202311429430A CN117205151A CN 117205151 A CN117205151 A CN 117205151A CN 202311429430 A CN202311429430 A CN 202311429430A CN 117205151 A CN117205151 A CN 117205151A
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- amikacin sulfate
- injection
- parts
- preparation
- amikacin
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- YWMSSKBMOFPBDM-UHFFFAOYSA-N 4-carbamoylbenzenesulfonyl chloride Chemical compound NC(=O)C1=CC=C(S(Cl)(=O)=O)C=C1 YWMSSKBMOFPBDM-UHFFFAOYSA-N 0.000 title claims abstract description 71
- 229960001656 amikacin sulfate Drugs 0.000 title claims abstract description 71
- 238000002347 injection Methods 0.000 title claims abstract description 45
- 239000007924 injection Substances 0.000 title claims abstract description 45
- 238000002360 preparation method Methods 0.000 title claims abstract description 34
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 34
- 239000008215 water for injection Substances 0.000 claims abstract description 34
- 230000001954 sterilising effect Effects 0.000 claims abstract description 27
- DWAQJAXMDSEUJJ-UHFFFAOYSA-M Sodium bisulfite Chemical compound [Na+].OS([O-])=O DWAQJAXMDSEUJJ-UHFFFAOYSA-M 0.000 claims abstract description 25
- 235000010267 sodium hydrogen sulphite Nutrition 0.000 claims abstract description 25
- 239000004289 sodium hydrogen sulphite Substances 0.000 claims abstract description 20
- 238000004659 sterilization and disinfection Methods 0.000 claims abstract description 18
- 239000000243 solution Substances 0.000 claims abstract description 16
- 238000000034 method Methods 0.000 claims abstract description 14
- 238000001914 filtration Methods 0.000 claims abstract description 10
- 238000003756 stirring Methods 0.000 claims abstract description 10
- 238000011049 filling Methods 0.000 claims abstract description 9
- 230000001105 regulatory effect Effects 0.000 claims abstract description 9
- 239000002994 raw material Substances 0.000 claims abstract description 8
- WBHQBSYUUJJSRZ-UHFFFAOYSA-M sodium bisulfate Chemical compound [Na+].OS([O-])(=O)=O WBHQBSYUUJJSRZ-UHFFFAOYSA-M 0.000 claims abstract description 3
- 229910000342 sodium bisulfate Inorganic materials 0.000 claims abstract description 3
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical group [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 42
- 229960004821 amikacin Drugs 0.000 claims description 13
- LKCWBDHBTVXHDL-RMDFUYIESA-N amikacin Chemical compound O([C@@H]1[C@@H](N)C[C@H]([C@@H]([C@H]1O)O[C@@H]1[C@@H]([C@@H](N)[C@H](O)[C@@H](CO)O1)O)NC(=O)[C@@H](O)CCN)[C@H]1O[C@H](CN)[C@@H](O)[C@H](O)[C@H]1O LKCWBDHBTVXHDL-RMDFUYIESA-N 0.000 claims description 13
- 239000000825 pharmaceutical preparation Substances 0.000 abstract description 4
- 230000015556 catabolic process Effects 0.000 abstract description 3
- 238000006731 degradation reaction Methods 0.000 abstract description 3
- 239000003814 drug Substances 0.000 description 15
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 12
- 239000007788 liquid Substances 0.000 description 12
- 239000000203 mixture Substances 0.000 description 9
- 239000004695 Polyether sulfone Substances 0.000 description 6
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 6
- 230000001276 controlling effect Effects 0.000 description 6
- 238000001816 cooling Methods 0.000 description 6
- 238000002844 melting Methods 0.000 description 6
- 230000008018 melting Effects 0.000 description 6
- 238000002156 mixing Methods 0.000 description 6
- 229910052757 nitrogen Inorganic materials 0.000 description 6
- 239000001301 oxygen Substances 0.000 description 6
- 229910052760 oxygen Inorganic materials 0.000 description 6
- 229920006393 polyether sulfone Polymers 0.000 description 6
- 238000007789 sealing Methods 0.000 description 6
- 239000000022 bacteriostatic agent Substances 0.000 description 5
- 230000000052 comparative effect Effects 0.000 description 4
- 229940079593 drug Drugs 0.000 description 4
- 238000009472 formulation Methods 0.000 description 4
- 239000012535 impurity Substances 0.000 description 3
- QAOWNCQODCNURD-UHFFFAOYSA-N Sulfuric acid Chemical compound OS(O)(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-N 0.000 description 2
- 238000002474 experimental method Methods 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 241000588724 Escherichia coli Species 0.000 description 1
- CEAZRRDELHUEMR-URQXQFDESA-N Gentamicin Chemical compound O1[C@H](C(C)NC)CC[C@@H](N)[C@H]1O[C@H]1[C@H](O)[C@@H](O[C@@H]2[C@@H]([C@@H](NC)[C@@](C)(O)CO2)O)[C@H](N)C[C@@H]1N CEAZRRDELHUEMR-URQXQFDESA-N 0.000 description 1
- 229930182566 Gentamicin Natural products 0.000 description 1
- 241000588769 Proteus <enterobacteria> Species 0.000 description 1
- 241000589517 Pseudomonas aeruginosa Species 0.000 description 1
- 241000191967 Staphylococcus aureus Species 0.000 description 1
- 229940126574 aminoglycoside antibiotic Drugs 0.000 description 1
- 239000002647 aminoglycoside antibiotic agent Substances 0.000 description 1
- 230000000844 anti-bacterial effect Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 239000003153 chemical reaction reagent Substances 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 229960002518 gentamicin Drugs 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 238000012827 research and development Methods 0.000 description 1
- 230000035945 sensitivity Effects 0.000 description 1
- 229940079827 sodium hydrogen sulfite Drugs 0.000 description 1
- 238000001228 spectrum Methods 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
- 230000001988 toxicity Effects 0.000 description 1
- 231100000419 toxicity Toxicity 0.000 description 1
Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention relates to amikacin sulfate injection and a preparation method thereof, wherein the amikacin sulfate injection comprises the following raw materials: 50 to 500 parts of amikacin sulfate, 0.5 to 6 parts of sodium bisulphite and 0.6 to 2 parts of pH regulator by weight, and the balance is complemented by water for injection; the preparation method comprises the following specific steps: 1) Adding sodium bisulfate and amikacin sulfate into water for injection according to the prescription amount, stirring and dissolving; adding a pH regulator into the solution obtained in the step 1), regulating the pH value to 5.3-6.3, and fixing the volume; 2) Filtering the step 2), and filling; 3) Sterilizing under damp heat. The amikacin sulfate injection has the advantages of solving the problem that amikacin sulfate injection cannot meet the requirement of excessive sterilization of a terminal, improving the thermal stability of the amikacin sulfate injection, and effectively reducing the degradation of amikacin sulfate in the wet heat sterilization process, thereby ensuring the stability of a pharmaceutical preparation in the transportation and storage processes.
Description
Technical Field
The invention relates to the technical field of medicines, in particular to amikacin sulfate injection and a preparation method thereof.
Background
Amikacin Sulfate (Amikacin Sulfate), named Amikacin Sulfate, is a semisynthetic aminoglycoside antibiotic, has an antibacterial spectrum similar to gentamicin, and is effective against Staphylococcus aureus, pseudomonas aeruginosa, escherichia coli, proteus, and the like. The product is marketed in the United states in 1993 at least as early as 50mg/ml;250mg/ml;500mg/ml and other specifications; 1ml:100mg;2ml:200mg specification Nichiiko is currently only marketed in Japan. There are several imitations of pharmacy in China to be marketed, and no imported medicines are marketed.
The original research medicine Nichiiko contains a bacteriostatic agent, the bacteriostatic agent has definite toxicity to cells, the bacteriostatic agent is possibly used for producing safety risks for human bodies, and the use of the bacteriostatic agent in the clear injection in the research and development technical instruction of medicine injection issued by CDE is strictly controlled, so that the use of the bacteriostatic agent is not suggested in principle, and the prescription process of the medicine is improved for improving the medication safety of human bodies.
Disclosure of Invention
The invention aims to overcome the defects in the prior art, provides amikacin sulfate injection and a preparation method thereof, solves the problem that amikacin sulfate injection cannot meet the requirement of excessive sterilization of a terminal, improves the thermal stability of amikacin sulfate injection, and effectively reduces the degradation of amikacin sulfate in the process of damp-heat sterilization, thereby ensuring the stability of a pharmaceutical preparation in the process of transportation and storage.
The invention is realized by the following technical scheme: in one aspect, a preparation method of amikacin sulfate injection is provided, and the amikacin sulfate injection comprises the following raw materials: 50 to 500 parts of amikacin sulfate, 0.5 to 6 parts of sodium bisulphite and 0.5 to 3 parts of pH regulator by weight, and the balance is complemented by water for injection; the preparation method comprises the following specific steps:
1) Adding sodium bisulfate and amikacin sulfate into water for injection according to the prescription amount, stirring and dissolving;
2) Adding a pH regulator into the solution obtained in the step 1), regulating the pH value to 5.3-6.3, and fixing the volume;
3) Filtering the solution obtained in the step 2), and filling;
4) Sterilizing under damp heat.
Further, the pH regulator is sodium hydroxide solution with the concentration of 1mol/L to 4 mol/L.
Further, the amikacin sulfate injection consists of the following raw materials: 100-400 parts of amikacin sulfate, 1-3 parts of sodium bisulfite and 0.6-2 parts of pH regulator, and the balance is complemented by water for injection.
Further, the amikacin sulfate injection consists of the following raw materials: 267 parts of amikacin sulfate, 2 parts of sodium bisulfite and 1.2 parts of pH regulator, and the balance is complemented by water for injection.
Further, in step 2), the content of amikacin in the obtained solution is 95.0% -105.0% of the labeled amount thereof.
Preferably, in step 3), the mesh size of the filtered cartridge is 0.22 μm.
Further, in the step 4), the sterilization temperature is 121 ℃ and the sterilization time is 8-15 min.
Also provided is amikacin sulfate injection, which is prepared by the preparation method.
The invention has the beneficial effects that: the invention solves the problem that amikacin sulfate injection cannot meet the requirement of excessive sterilization at the terminal, improves the thermal stability of amikacin sulfate injection, and effectively reduces the degradation of amikacin sulfate in the wet heat sterilization process, thereby ensuring the stability of the pharmaceutical preparation in the transportation and storage processes.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described in the following in conjunction with the embodiments of the present invention, and it is obvious that the described embodiments are only some embodiments of the present invention, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention. The experimental procedures, which do not address the specific conditions in the examples below, are generally carried out under conventional conditions or under conditions recommended by the manufacturer. All percentages, ratios, proportions or parts are by weight unless otherwise indicated.
Example 1
The preparation method of amikacin sulfate injection comprises the following steps: amikacin sulfate, sodium bisulphite, sodium hydroxide, the balance being 200mL of water for injection; the preparation method comprises the following specific steps:
1) Adding 85% (w/v) water for injection into a liquid preparation tank, and cooling to below 50deg.C; then 20g of amikacin sulfate is calculated by amikacin; and 0.2g of sodium bisulphite is added into the water for injection, and the mixture is continuously stirred until the sodium bisulphite is completely dissolved;
2) Adding 1mol/L sodium hydroxide into the solution obtained in the step 1), regulating the pH value to 5.3, adding water for injection to 200mL, stirring and mixing uniformly, and detecting that the amikacin content is 105.0% of the marked amount;
3) Filtering the liquid medicine obtained in the step 2) through a 0.22 mu m polyether sulfone filter element, filling under a nitrogen flow, sealing in a melting way, and controlling residual oxygen below 3%;
4) And (3) carrying out damp heat sterilization, and sterilizing the encapsulated product obtained in the step (3) at 121 ℃ for 12min.
Example 2
The preparation method of amikacin sulfate injection comprises the following steps: amikacin sulfate, sodium bisulphite, sodium hydroxide, the balance being 200mL of water for injection; the preparation method comprises the following specific steps:
1) Adding 85% (w/v) water for injection into a liquid preparation tank, and cooling to below 50deg.C; then 20g of amikacin sulfate is calculated by amikacin; and 0.2g of sodium bisulphite is added into the water for injection, and the mixture is continuously stirred until the sodium bisulphite is completely dissolved;
2) Adding 1mol/L sodium hydroxide into the solution obtained in the step 1), regulating the pH value to 5.8, adding water for injection to 200mL, stirring and mixing uniformly, and detecting that the amikacin content is 95.0% of the marked amount;
3) Filtering the liquid medicine obtained in the step 2) through a 0.22 mu m polyether sulfone filter element, filling under a nitrogen flow, sealing in a melting way, and controlling residual oxygen below 3%;
4) And (3) carrying out damp heat sterilization, and sterilizing the encapsulated product obtained in the step (3) at 121 ℃ for 15min.
Example 3
The preparation method of amikacin sulfate injection comprises the following steps: amikacin sulfate, sodium bisulphite, sodium hydroxide, the balance being 200mL of water for injection; the preparation method comprises the following specific steps:
1) Adding 85% (w/v) water for injection into a liquid preparation tank, and cooling to below 50deg.C; then 20g of amikacin sulfate is calculated by amikacin; and 0.2g of sodium bisulphite is added into the water for injection, and the mixture is continuously stirred until the sodium bisulphite is completely dissolved;
2) Adding 1mol/L sodium hydroxide into the solution obtained in the step 1), regulating the pH value to 6.3, adding water for injection to 200mL, stirring and mixing uniformly, and detecting that the amikacin content is 95.0% of the marked amount;
3) Filtering the liquid medicine obtained in the step 2) through a 0.22 mu m polyether sulfone filter element, filling under a nitrogen flow, sealing in a melting way, and controlling residual oxygen below 3%;
4) And (3) carrying out damp heat sterilization, and sterilizing the encapsulated product obtained in the step (3) at 121 ℃ for 12min.
Example 4
The preparation method of amikacin sulfate injection comprises the following steps: amikacin sulfate, sodium bisulphite, sodium hydroxide, the balance being 200mL of water for injection; the preparation method comprises the following specific steps:
1) Adding 85% (w/v) water for injection into a liquid preparation tank, and cooling to below 50deg.C; then 20g of amikacin sulfate is calculated by amikacin; and 0.3g of sodium bisulphite is added into the water for injection, and the mixture is continuously stirred until the sodium bisulphite is completely dissolved;
2) Adding 1mol/L sodium hydroxide into the solution obtained in the step 1), regulating the pH value to 5.8, adding water for injection to 200mL, stirring and mixing uniformly, and detecting that the amikacin content is 105.0% of the marked amount;
3) Filtering the liquid medicine obtained in the step 2) through a 0.22 mu m polyether sulfone filter element, filling under a nitrogen flow, sealing in a melting way, and controlling residual oxygen below 3%;
4) And (3) carrying out damp heat sterilization, and sterilizing the encapsulated product obtained in the step (3) at 121 ℃ for 12min.
Example 5
The preparation method of amikacin sulfate injection comprises the following steps: amikacin sulfate, sodium bisulphite, sodium hydroxide, the balance being 200mL of water for injection; the preparation method comprises the following specific steps:
1) Adding 85% (w/v) water for injection into a liquid preparation tank, and cooling to below 50deg.C; then 20g of amikacin sulfate is calculated by amikacin; and 0.6g of sodium bisulphite is added into the water for injection, and the mixture is continuously stirred until the sodium bisulphite is completely dissolved;
2) Adding 1mol/L sodium hydroxide into the solution obtained in the step 1), regulating the pH value to 5.8, adding water for injection to 200mL, stirring and mixing uniformly, and detecting that the amikacin content is 105.0% of the marked amount;
3) Filtering the liquid medicine obtained in the step 2) through a 0.22 mu m polyether sulfone filter element, filling under a nitrogen flow, sealing in a melting way, and controlling residual oxygen below 3%;
4) And (3) carrying out damp heat sterilization, and sterilizing the encapsulated product obtained in the step (3) at 121 ℃ for 12min.
Comparative example 1
The preparation method of amikacin sulfate injection comprises the following steps: amikacin sulfate, sodium bisulphite, sodium hydroxide, the balance being 200mL of water for injection; the preparation method comprises the following specific steps:
1) Adding 85% (w/v) water for injection into a liquid preparation tank, and cooling to below 50deg.C; adding 20g of amikacin sulfate into the water for injection according to the amikacin, and continuously stirring until the amikacin sulfate is completely dissolved;
2) Adding sodium hydroxide or sulfuric acid into the solution obtained in the step 1), regulating the pH value to 5.8, adding water for injection to 200mL, and stirring and uniformly mixing;
3) Filtering the liquid medicine obtained in the step 2) through a 0.22 mu m polyether sulfone filter element, filling under a nitrogen flow, sealing in a melting way, and controlling residual oxygen below 3%;
4) And (3) carrying out damp heat sterilization, and sterilizing the encapsulated product obtained in the step (3) at 121 ℃ for 15min.
Stability experiment:
the stability studies of examples 1 to 5 and comparative example 1 described above, specifically including the sensitivity studies of the injection to light and high temperature, are shown in tables 3 and 4 below.
TABLE 3 Table 3
As can be seen from the comparison of Table 3, the pH ranges of examples 1, 2 and 3 of the present invention are 5.3-6.3, the impurities are all in line with the limit, no obvious difference exists between the three batches, and the quality of the preparation is relatively stable. Furthermore, it was found from the results of examples 2, 4 and 5 that the sodium hydrogensulfite of the present invention had relatively stable quality of the preparation in the range of 1mg/ml to 3 mg/ml.
The test results of example 1 and comparative example 1 are shown in table 4 below;
TABLE 4 Table 4
As is clear from Table 4, comparative example 1 does not contain sodium bisulphite, is colored for 0 days, and is further enhanced in color under high temperature conditions, thereby demonstrating that the stability of the present invention is better.
Effect examples
Samples were prepared from the formulation disclosed in the specification of the original development reagent Nichiiko by Nichiiko corporation and the formulation of amikacin sulfate injection disclosed in the present invention, and the raw material formulation was as follows in the experimental formulation of amikacin sulfate injection of Table 1:
TABLE 1
The above samples were sterilized at 121℃for 12 minutes, and the results of comparing the impurity conditions before and after sterilization are shown in Table 2 below.
TABLE 2
The results in the table 2 show that the related substances of amikacin sulfate injection prepared by adopting the original prescription of the grinded medicine do not meet the standard regulation, and the disclosed prescription cannot enable the amikacin sulfate injection to withstand the terminal oversterilization condition; the preparation method disclosed by the patent can effectively reduce the generation of impurities in the sterilization process of amikacin sulfate injection, improve the stability of the amikacin sulfate injection, ensure the stability of a pharmaceutical preparation in the transportation and storage processes, reduce the medication risk and improve the safety of the medicine.
Finally, it should be noted that: the foregoing description is only illustrative of the preferred embodiments of the present invention, and although the present invention has been described in detail with reference to the foregoing embodiments, it will be apparent to those skilled in the art that modifications may be made to the embodiments described, or equivalents may be substituted for elements thereof, and any modifications, equivalents, improvements or changes may be made without departing from the spirit and principles of the present invention.
Claims (8)
1. The preparation method of amikacin sulfate injection is characterized in that the amikacin sulfate injection comprises the following raw materials: 50 to 500 parts of amikacin sulfate, 0.5 to 6 parts of sodium bisulphite and 0.5 to 3 parts of pH regulator by weight, and the balance is complemented by water for injection; the preparation method comprises the following specific steps:
1) Adding sodium bisulfate and amikacin sulfate into water for injection according to the prescription amount, stirring and dissolving;
2) Adding a pH regulator into the solution obtained in the step 1), regulating the pH value to 5.3-6.3, and fixing the volume;
3) Filtering the solution obtained in the step 2), and filling;
4) Sterilizing under damp heat.
2. The method for preparing amikacin sulfate injection according to claim 1, wherein the pH regulator is a sodium hydroxide solution of 1mol/L to 4 mol/L.
3. The preparation method of amikacin sulfate injection as claimed in claim 1, wherein the amikacin sulfate injection comprises the following raw materials: 100-400 parts of amikacin sulfate, 1-3 parts of sodium bisulfite and 0.6-2 parts of pH regulator, and the balance is complemented by water for injection.
4. The method for preparing amikacin sulfate injection according to claim 3, wherein the amikacin sulfate injection comprises the following raw materials: 267 parts of amikacin sulfate, 2 parts of sodium bisulfite and 1.2 parts of pH regulator, and the balance is complemented by water for injection.
5. The method for preparing amikacin sulfate injection according to claim 1, wherein in the step 2), the amikacin content in the obtained solution is 95.0% -105.0% of the labeled amount.
6. The method for preparing amikacin sulfate injection according to claim 1, wherein in the step 3), the mesh number of the filtering core is 0.22 μm.
7. The method for preparing amikacin sulfate injection according to claim 1, wherein in the step 4), the sterilization temperature is 121 ℃ and the sterilization time is 8-15 min.
8. Amikacin sulfate injection, characterized in that the amikacin sulfate injection is prepared by the preparation method of any one of claims 1-7.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202311429430.0A CN117205151A (en) | 2023-10-31 | 2023-10-31 | Amikacin sulfate injection and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202311429430.0A CN117205151A (en) | 2023-10-31 | 2023-10-31 | Amikacin sulfate injection and preparation method thereof |
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| CN117205151A true CN117205151A (en) | 2023-12-12 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN117618342A (en) * | 2023-12-15 | 2024-03-01 | 浙江诚意药业股份有限公司 | Preparation method of amikacin sulfate injection |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN117618342A (en) * | 2023-12-15 | 2024-03-01 | 浙江诚意药业股份有限公司 | Preparation method of amikacin sulfate injection |
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