CN118001234A - Potassium aspartate injection and preparation method thereof - Google Patents
Potassium aspartate injection and preparation method thereof Download PDFInfo
- Publication number
- CN118001234A CN118001234A CN202410164514.4A CN202410164514A CN118001234A CN 118001234 A CN118001234 A CN 118001234A CN 202410164514 A CN202410164514 A CN 202410164514A CN 118001234 A CN118001234 A CN 118001234A
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- Prior art keywords
- potassium aspartate
- injection
- liquid medicine
- potassium
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- YKZPPPNXRZHVGX-PXYKVGKMSA-L dipotassium;(2s)-2-aminobutanedioate;hydron;hydrate Chemical compound [H+].[H+].O.[K+].[K+].[O-]C(=O)[C@@H](N)CC([O-])=O.[O-]C(=O)[C@@H](N)CC([O-])=O YKZPPPNXRZHVGX-PXYKVGKMSA-L 0.000 title claims abstract description 137
- 229940068988 potassium aspartate Drugs 0.000 title claims abstract description 137
- 238000002347 injection Methods 0.000 title claims abstract description 97
- 239000007924 injection Substances 0.000 title claims abstract description 97
- 238000002360 preparation method Methods 0.000 title claims abstract description 24
- 239000003814 drug Substances 0.000 claims abstract description 48
- 239000007788 liquid Substances 0.000 claims abstract description 42
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 33
- 238000001514 detection method Methods 0.000 claims abstract description 29
- 238000011049 filling Methods 0.000 claims abstract description 28
- 239000004695 Polyether sulfone Substances 0.000 claims abstract description 26
- 229920006393 polyether sulfone Polymers 0.000 claims abstract description 26
- 238000007689 inspection Methods 0.000 claims abstract description 17
- 238000007789 sealing Methods 0.000 claims abstract description 11
- 238000001914 filtration Methods 0.000 claims abstract description 9
- 239000011148 porous material Substances 0.000 claims abstract description 7
- 238000000034 method Methods 0.000 claims description 11
- 238000005286 illumination Methods 0.000 claims description 9
- 239000000243 solution Substances 0.000 claims description 4
- 239000000126 substance Substances 0.000 abstract description 6
- 229940079593 drug Drugs 0.000 abstract description 4
- 239000000825 pharmaceutical preparation Substances 0.000 abstract description 2
- 230000000052 comparative effect Effects 0.000 description 17
- 239000012535 impurity Substances 0.000 description 9
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 description 8
- 230000001954 sterilising effect Effects 0.000 description 8
- 238000004806 packaging method and process Methods 0.000 description 6
- 238000012360 testing method Methods 0.000 description 6
- 238000004659 sterilization and disinfection Methods 0.000 description 5
- 229910052799 carbon Inorganic materials 0.000 description 4
- 230000007774 longterm Effects 0.000 description 4
- 238000003860 storage Methods 0.000 description 4
- 239000008215 water for injection Substances 0.000 description 4
- 238000004519 manufacturing process Methods 0.000 description 3
- CKLJMWTZIZZHCS-UWTATZPHSA-N D-aspartic acid Chemical compound OC(=O)[C@H](N)CC(O)=O CKLJMWTZIZZHCS-UWTATZPHSA-N 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 229910001414 potassium ion Inorganic materials 0.000 description 2
- 239000002994 raw material Substances 0.000 description 2
- 108030001720 Bontoxilysin Proteins 0.000 description 1
- 206010019280 Heart failures Diseases 0.000 description 1
- 208000019025 Hypokalemia Diseases 0.000 description 1
- AHLPHDHHMVZTML-BYPYZUCNSA-N L-Ornithine Chemical compound NCCC[C@H](N)C(O)=O AHLPHDHHMVZTML-BYPYZUCNSA-N 0.000 description 1
- AHLPHDHHMVZTML-UHFFFAOYSA-N Orn-delta-NH2 Natural products NCCCC(N)C(O)=O AHLPHDHHMVZTML-UHFFFAOYSA-N 0.000 description 1
- UTJLXEIPEHZYQJ-UHFFFAOYSA-N Ornithine Natural products OC(=O)C(C)CCCN UTJLXEIPEHZYQJ-UHFFFAOYSA-N 0.000 description 1
- 229940024606 amino acid Drugs 0.000 description 1
- 235000001014 amino acid Nutrition 0.000 description 1
- 150000001413 amino acids Chemical class 0.000 description 1
- 235000003704 aspartic acid Nutrition 0.000 description 1
- OQFSQFPPLPISGP-UHFFFAOYSA-N beta-carboxyaspartic acid Natural products OC(=O)C(N)C(C(O)=O)C(O)=O OQFSQFPPLPISGP-UHFFFAOYSA-N 0.000 description 1
- 229940053031 botulinum toxin Drugs 0.000 description 1
- 239000002775 capsule Substances 0.000 description 1
- 208000019425 cirrhosis of liver Diseases 0.000 description 1
- 230000001419 dependent effect Effects 0.000 description 1
- 208000021264 digitalis poisoning Diseases 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 238000004090 dissolution Methods 0.000 description 1
- 230000002349 favourable effect Effects 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 238000009776 industrial production Methods 0.000 description 1
- 238000011835 investigation Methods 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 229960003104 ornithine Drugs 0.000 description 1
- 230000003647 oxidation Effects 0.000 description 1
- 238000007254 oxidation reaction Methods 0.000 description 1
- 208000024896 potassium deficiency disease Diseases 0.000 description 1
- 238000000275 quality assurance Methods 0.000 description 1
- 238000013112 stability test Methods 0.000 description 1
- 239000003826 tablet Substances 0.000 description 1
- 230000004102 tricarboxylic acid cycle Effects 0.000 description 1
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- Medicinal Preparation (AREA)
Abstract
The invention relates to the technical field of pharmaceutical preparations, and in particular discloses a potassium aspartate injection and a preparation method thereof. The preparation method provided by the invention comprises the following steps: adding the prescribed amount of potassium aspartate into the injection water with the total volume of 70-80% of the total volume at 45-55 ℃, and then adding the injection water to the total volume to obtain the potassium aspartate liquid medicine; filtering the potassium aspartate liquid medicine by a multi-stage polyether sulfone filter element with sequentially reduced pore diameters to obtain potassium aspartate liquid medicine; and (3) filling the filtered potassium aspartate liquid medicine, sealing, performing light inspection and leak detection to obtain the potassium aspartate injection. The invention can effectively reduce the content of related substances, improve the product quality of the potassium aspartate injection and has very important significance for improving the medication safety of patients by limiting the adding temperature of the potassium aspartate, utilizing a multistage polyethersulfone filter core to filter, limiting the temperature during filling and carrying out light inspection and leak detection on the liquid medicine sealed by filling.
Description
Technical Field
The invention relates to the technical field of pharmaceutical preparations, in particular to a potassium aspartate injection and a preparation method thereof.
Background
The aspartic acid in the potassium aspartate injection is an amino acid, participates in tricarboxylic acid cycle and ornithine cycle in vivo, has strong affinity with cells, can carry potassium ions into the cells, and improves the content of the potassium ions inside and outside the cells; the medicine containing potassium aspartate is used for treating heart failure, liver cirrhosis and other diseases, and the potassium aspartate medicine may be also used for treating hypokalemia and digitalis poisoning. However, at present, the preparation of potassium aspartate is in the forms of tablets, capsules, injection and the like, but the preparation has the problem of complicated process conditions.
Regarding potassium aspartate injection, the existing preparation method of the potassium aspartate injection mainly comprises the following two steps: 1. adding potassium aspartate into the water for injection, adjusting the pH, adding medicinal carbon, filtering while the water is hot, adding the rest water for injection, filling, sealing, and sterilizing at high temperature to obtain potassium aspartate injection; 2. adding water for injection into a concentrated preparation tank, adding potassium aspartate when the temperature is reduced to 25-60 ℃, adding the rest water for injection to the total volume, filtering, filling, and sterilizing at high temperature to obtain potassium aspartate injection; however, the above method has many problems, such as complicated process and strict production conditions; the quality difference of the prepared products is large; new impurities are introduced by adding the medicinal carbon; the high-temperature sterilization time is long, so that the content of related substances in the product is increased; moreover, the method can only improve the quality of the injection in the initial stage of preparation, reduce the content of the isomer (D-aspartic acid) and cannot achieve the long-term product quality assurance. Therefore, the preparation method of the potassium aspartate injection has important significance for solving the problem of poor long-term storage stability of the existing potassium aspartate injection.
Disclosure of Invention
In view of the above, the invention provides a potassium aspartate injection and a preparation method thereof, wherein the adding temperature of potassium aspartate is limited, a multi-stage polyether sulfone filter element is utilized to filter and replace the traditional high-temperature sterilization and active carbon adding process, the temperature during filling is limited, and the liquid medicine sealed by filling is subjected to light inspection and leak detection, so that the content of related substances can be effectively reduced, the product quality of the potassium aspartate injection is improved, and the potassium aspartate injection has very important significance for improving the medication safety of patients.
In order to solve the technical problems, the technical scheme provided by the invention is as follows:
A preparation method of potassium aspartate injection comprises the following steps:
Step a, adding the prescribed amount of potassium aspartate into injection water with the total volume of 70-80% of the total volume at the temperature of 45-55 ℃, and then adding the injection water to the total volume to obtain potassium aspartate liquid medicine;
Step b, filtering the potassium aspartate liquid medicine through a multi-stage polyether sulfone filter element with sequentially reduced pore diameters, and filtering the potassium aspartate liquid medicine;
C, filling, sealing, performing light inspection and leak detection on the filtered potassium aspartate liquid medicine to obtain the potassium aspartate injection;
wherein the temperature of the filling is less than 40 ℃.
Compared with the prior art, the preparation method of the potassium aspartate injection provided by the invention has the advantages that the addition temperature of the potassium aspartate is controlled, the dissolution rate of raw materials is improved, the preparation time is shortened, and meanwhile, the specific configuration temperature can also effectively reduce the oxidation of raw material medicines in the potassium aspartate injection, so that the content of related substance impurities is greatly reduced, and the long-term storage stability of the product is improved; the invention uses the multi-stage polyethersulfone filter element filtering technology to replace the traditional high-temperature sterilization and active carbon adding technology, thereby avoiding the problem of increased impurity content of the product when the product is placed for a long time due to high-temperature sterilization, avoiding the problem of increased impurity content of the product caused by introducing new impurities into the active carbon, and further improving the safety of the product; the stability of the potassium aspartate injection can be further improved by limiting the temperature during filling, and the product quality of the potassium aspartate injection is ensured; the liquid medicine filled and sealed is subjected to lamp inspection and leakage detection, so that products such as leakage can be removed to the greatest extent, and the long-term storage stability of the products is improved.
The invention can effectively reduce the content of related substances, improve the product quality of the potassium aspartate injection and have important significance for improving the medication safety of patients by limiting the adding temperature of the potassium aspartate, utilizing the multi-stage polyether sulfone filter element to filter and replace the traditional high-temperature sterilization and active carbon adding process, limiting the temperature during filling and carrying out lamp inspection and leak detection on the liquid medicine sealed by filling.
Preferably, in the step a, the pH of the potassium aspartate solution is 5.5-7.5.
The pH of the potassium aspartate solution can be adjusted by a pH adjustor.
Preferably, in the step b, the multi-stage filter element is a two-stage polyethersulfone filter element, wherein the pore diameter of the first-stage polyethersulfone filter element is 0.45 μm, and the pore diameter of the second-stage polyethersulfone filter element is 0.2 μm.
According to the invention, the special secondary polyether sulfone filter element is selected for filtration, so that the introduction of activated carbon can be avoided, and the botulinum toxin level in the product is ensured.
Preferably, in step c, the conditions of the light inspection are as follows: the illumination intensity is 1000LX-1500LX.
The preferable lamp inspection condition can accurately detect unqualified products on the premise of not influencing the increase of the content of related substances.
Preferably, in step c, the leak detection conditions are as follows: the discharge voltage is 17kV-19kV, and the threshold value is 5.
The traditional color water leakage detection method is too dependent on subjective judgment of people, and has the risk of misjudgment.
The second aspect of the invention provides a potassium aspartate injection, which is prepared by the preparation method of the potassium aspartate injection.
Preferably, each 1mL of potassium aspartate injection comprises: 171.2mg of potassium aspartate and pH of 5.5-7.5.
The potassium aspartate injection with obviously reduced impurity types and contents prepared by the invention obviously improves the storage stability of the potassium aspartate injection, has insignificant increase of impurity contents in stability investigation tests, improves the production efficiency, reduces the production cost, is convenient for realizing industrial production, and has wide application prospect.
Detailed Description
The present invention will be described in further detail with reference to the following examples in order to make the objects, technical solutions and advantages of the present invention more apparent. It should be understood that the specific embodiments described herein are for purposes of illustration only and are not intended to limit the scope of the invention.
In order to better illustrate the present invention, the following examples are provided for further illustration.
Example 1
The embodiment provides a potassium aspartate injection, each 1mL of the potassium aspartate injection comprises: 171.2mg of potassium aspartate;
The embodiment also provides a preparation method of the potassium aspartate injection, which comprises the following steps:
Step a, adding the prescribed amount of potassium aspartate into injection water with the total volume of 80% of the total volume at 50 ℃, and then adding the injection water to the total volume of the injection water to obtain potassium aspartate liquid medicine;
Step b, the potassium aspartate liquid medicine is filtered by sequentially passing through a polyether sulfone filter core with the aperture of 0.45 mu m and a polyether sulfone filter core with the aperture of 0.2 mu m, so as to obtain the potassium aspartate liquid medicine;
And c, filling the filtered potassium aspartate liquid medicine, controlling the filling temperature to be 35 ℃, sealing, performing lamp inspection under the illumination intensity of 1000LX, setting the voltage of a high-voltage discharge leakage detection machine to be 18KV, setting the threshold to be 5, performing leakage detection, and packaging after the leakage detection is qualified to obtain the potassium aspartate injection.
Example 2
The embodiment provides a potassium aspartate injection, each 1mL of the potassium aspartate injection comprises: 171.2mg of potassium aspartate;
The embodiment also provides a preparation method of the potassium aspartate injection, which comprises the following steps:
step a, adding the prescribed amount of potassium aspartate into injection water with the total volume of 70% at 45 ℃, and then adding the injection water to the total volume of the injection water to obtain potassium aspartate liquid medicine;
Step b, the potassium aspartate liquid medicine is filtered by sequentially passing through a polyether sulfone filter core with the aperture of 0.45 mu m and a polyether sulfone filter core with the aperture of 0.2 mu m, so as to obtain the potassium aspartate liquid medicine;
And c, filling the filtered potassium aspartate liquid medicine, controlling the filling temperature to be 38 ℃, sealing, performing lamp inspection under the illumination intensity of 1500LX, setting the voltage of a high-voltage discharge leakage detection machine to be 17KV, setting the threshold to be 5, performing leakage detection, and packaging after the leakage detection is qualified to obtain the potassium aspartate injection.
Example 3
The embodiment provides a potassium aspartate injection, each 1mL of the potassium aspartate injection comprises: 171.2mg of potassium aspartate;
The embodiment also provides a preparation method of the potassium aspartate injection, which comprises the following steps:
step a, adding the prescribed amount of potassium aspartate into injection water with the total volume of 75% at 55 ℃, and then adding the injection water to the total volume of the injection water to obtain potassium aspartate liquid medicine;
Step b, the potassium aspartate liquid medicine is filtered by sequentially passing through a polyether sulfone filter core with the aperture of 0.45 mu m and a polyether sulfone filter core with the aperture of 0.2 mu m, so as to obtain the potassium aspartate liquid medicine;
And c, filling the filtered potassium aspartate liquid medicine, controlling the filling temperature to be 30 ℃, sealing, performing lamp inspection under the illumination intensity of 1200LX, setting the voltage of a high-voltage discharge leakage detection machine to be 19KV, setting the threshold to be 5, performing leakage detection, and packaging after the leakage detection is qualified to obtain the potassium aspartate injection.
Comparative example 1
This comparative example provides a potassium aspartate injection comprising, per 1mL of potassium aspartate injection: 171.2mg of potassium aspartate;
The comparative example also provides a preparation method of the potassium aspartate injection, which comprises the following steps:
step a, adding the prescribed amount of potassium aspartate into injection water with the total volume of 80% of the total volume at 60 ℃, and then adding the injection water to the total volume of the injection water to obtain potassium aspartate liquid medicine;
Step b, the potassium aspartate liquid medicine is filtered by sequentially passing through a polyether sulfone filter core with the aperture of 0.45 mu m and a polyether sulfone filter core with the aperture of 0.2 mu m, so as to obtain the potassium aspartate liquid medicine;
And c, filling the filtered potassium aspartate liquid medicine, controlling the filling temperature to be 35 ℃, sealing, performing lamp inspection under the illumination intensity of 1000LX, setting the voltage of a high-voltage discharge leakage detection machine to be 18KV, setting the threshold to be 5, performing leakage detection, and packaging after the leakage detection is qualified to obtain the potassium aspartate injection.
Comparative example 2
This comparative example provides a potassium aspartate injection comprising, per 1mL of potassium aspartate injection: 171.2mg of potassium aspartate;
The comparative example also provides a preparation method of the potassium aspartate injection, which comprises the following steps:
step a, adding the prescribed amount of potassium aspartate into injection water with the total volume of 80% of the total volume at 40 ℃, and then adding the injection water to the total volume of the injection water to obtain potassium aspartate liquid medicine;
Step b, the potassium aspartate liquid medicine is filtered by sequentially passing through a polyether sulfone filter core with the aperture of 0.45 mu m and a polyether sulfone filter core with the aperture of 0.2 mu m, so as to obtain the potassium aspartate liquid medicine;
And c, filling the filtered potassium aspartate liquid medicine, controlling the filling temperature to be 35 ℃, sealing, performing lamp inspection under the illumination intensity of 1000LX, setting the voltage of a high-voltage discharge leakage detection machine to be 18KV, setting the threshold to be 5, performing leakage detection, and packaging after the leakage detection is qualified to obtain the potassium aspartate injection.
Comparative example 3
This comparative example provides a potassium aspartate injection comprising, per 1mL of potassium aspartate injection: 171.2mg of potassium aspartate;
The comparative example also provides a preparation method of the potassium aspartate injection, which comprises the following steps:
Step a, adding the prescribed amount of potassium aspartate into injection water with the total volume of 80% of the total volume at 50 ℃, and then adding the injection water to the total volume of the injection water to obtain potassium aspartate liquid medicine;
And b, filling the potassium aspartate liquid medicine, controlling the filling temperature to be 35 ℃, sealing, and sterilizing for 15min at 121 ℃ to obtain the potassium aspartate injection.
Comparative example 4
This comparative example provides a potassium aspartate injection comprising, per 1mL of potassium aspartate injection: 171.2mg of potassium aspartate;
The comparative example also provides a preparation method of the potassium aspartate injection, which comprises the following steps:
Step a, adding the prescribed amount of potassium aspartate into injection water with the total volume of 80% of the total volume at 50 ℃, and then adding the injection water to the total volume of the injection water to obtain potassium aspartate liquid medicine;
Step b, the potassium aspartate liquid medicine is filtered by sequentially passing through a polyether sulfone filter core with the aperture of 0.45 mu m and a polyether sulfone filter core with the aperture of 0.2 mu m, so as to obtain the potassium aspartate liquid medicine;
And c, filling the filtered potassium aspartate liquid medicine, controlling the filling temperature to be 45 ℃, sealing, performing lamp inspection under the illumination intensity of 1000LX, setting the voltage of a high-voltage discharge leakage detection machine to be 18KV, setting the threshold to be 5, performing leakage detection, and packaging after the leakage detection is qualified to obtain the potassium aspartate injection.
Quality inspection
Quality detection and stability tests were performed on the potassium aspartate injection products prepared in examples 1-3 and comparative examples 1-4, wherein the conditions of the light treatment were: 4500LUX, conditions of high temperature treatment are: the results are shown in tables 1-3 at 60 ℃.
Table 1 test results of examples 1-3
Table 2 comparative examples 1-2 test results
TABLE 3 comparative examples 3-4 test results
As can be seen from the above test data, compared with comparative examples 1 to 4, the potassium aspartate injection prepared in examples 1 to 3 of the present invention has lower impurity content and higher stability, and the increase of impurity content in the test process for 15 days under illumination and 30 days at high temperature is obviously lower than that of comparative examples 1 to 4, which proves that the potassium aspartate injection prepared in the examples of the present invention has better stability and safety, thereby being more favorable for improving the safety of clinical application.
The foregoing description of the preferred embodiments of the invention is not intended to be limiting, but rather is intended to cover all modifications, equivalents, or alternatives falling within the spirit and principles of the invention.
Claims (7)
1. The preparation method of the potassium aspartate injection is characterized by comprising the following steps:
Step a, adding the prescribed amount of potassium aspartate into injection water with the total volume of 70-80% of the total volume at the temperature of 45-55 ℃, and then adding the injection water to the total volume to obtain potassium aspartate liquid medicine;
Step b, filtering the potassium aspartate liquid medicine through a multi-stage polyether sulfone filter element with sequentially reduced pore diameters, and filtering the potassium aspartate liquid medicine;
C, filling, sealing, performing light inspection and leak detection on the filtered potassium aspartate liquid medicine to obtain the potassium aspartate injection; wherein the temperature of the filling is less than 40 ℃.
2. The method for preparing potassium aspartate injection according to claim 1, wherein in step a, the pH of the potassium aspartate solution is 5.5-7.5.
3. The method for preparing potassium aspartate injection according to claim 1, wherein in the step b, the multi-stage filter element is a two-stage polyethersulfone filter element, wherein the pore size of the first-stage polyethersulfone filter element is 0.45 μm, and the pore size of the second-stage polyethersulfone filter element is 0.2 μm.
4. The method for preparing potassium aspartate injection according to claim 1, wherein in step c, the condition for the light inspection is: the illumination intensity is 1000LX-1500LX.
5. The method for preparing potassium aspartate injection according to claim 1, wherein in step c, the leak detection condition is: the discharge voltage is 17kV-19kV, and the threshold value is 5.
6. The potassium aspartate injection according to any one of claims 1 to 5.
7. The potassium aspartate injection of claim 6, wherein each 1mL of the potassium aspartate injection comprises: 171.2mg of potassium aspartate and pH of 5.5-7.5.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202410164514.4A CN118001234A (en) | 2024-02-05 | 2024-02-05 | Potassium aspartate injection and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202410164514.4A CN118001234A (en) | 2024-02-05 | 2024-02-05 | Potassium aspartate injection and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN118001234A true CN118001234A (en) | 2024-05-10 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202410164514.4A Pending CN118001234A (en) | 2024-02-05 | 2024-02-05 | Potassium aspartate injection and preparation method thereof |
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| Country | Link |
|---|---|
| CN (1) | CN118001234A (en) |
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- 2024-02-05 CN CN202410164514.4A patent/CN118001234A/en active Pending
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