CN105213329A - Meglumine cyclic adenosine for injecta freeze-dried powder and preparation method thereof - Google Patents
Meglumine cyclic adenosine for injecta freeze-dried powder and preparation method thereof Download PDFInfo
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- CN105213329A CN105213329A CN201510762872.6A CN201510762872A CN105213329A CN 105213329 A CN105213329 A CN 105213329A CN 201510762872 A CN201510762872 A CN 201510762872A CN 105213329 A CN105213329 A CN 105213329A
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Abstract
The invention belongs to technical field of medicine, be specifically related to a kind of meglumine cyclic adenosine for injecta freeze-dried powder and preparation method thereof.Be made up of adenosine cyclophosphate and meglumine, the mass ratio of adenosine cyclophosphate and meglumine is 1: 0.55-0.65.The present invention, without the need to adding glycine, mannitol, sodium chloride, sodium citrate, citric acid, sodium hydrogen phosphate etc., improves drug safety and stability.The present invention also provides its preparation method, first use adenosine cyclophosphate and meglumine 1: 1 salify in molar ratio, pH to 5.8-7.0 is regulated again with meglumine, improve the stability of principal agent, through accelerated test test, this product stable content in 6 months, related substance change is less, extend the storage period of preparation, this preparation method technique is simple, is suitable for suitability for industrialized production.
Description
Technical field
The invention belongs to technical field of medicine, be specifically related to a kind of meglumine cyclic adenosine for injecta freeze-dried powder and preparation method thereof.
Background technology
Meglumine adenosine cycle phosphate is a kind of for heart failure, myocarditis, sick sinus syndrome, coronary heart disease and cardiomyopathy, can be used for ARR auxiliary treatment.Through Clinical practice determined curative effect for many years, its Main Function mechanism is: meglumine adenosine cycle phosphate is non-digitalis cardiac tonic, has positive inotropic action, can strengthen myocardial contraction, improves myocardium blood-pumping function, has blood vessel dilating effect, can reduce myocardial oxygen consumption; Improve metabolism of myocardium, the cardiac muscle of protection ischemia, anoxia; Sinuatrial node P cell function can be improved.
On market, existing meglumine adenosine cycle phosphate injection is in long-term storage process, meglumine adenosine cycle phosphate draws by force moist, melting degraded after the moisture absorption causes the content of preparation to decline, related substance increases, color burn, the stability of this product is relevant with the pH of itself, the salt of this strain adenosine cyclophosphate and meglumine, when pH is between 5.8 ~ 6.0, stability is better, pH is on the low side or the higher dissolubility that all can affect product, draw moist, prior art with the addition of citric acid as stabilizing agent in injection, but the drug safety of stabilizing agent does not ensure fully, simultaneously due to needs high temperature sterilize, the stability of product is bad, related substance increases obviously after sterilization, and in storage process, medicine is easily hydrolyzed.
Summary of the invention
For the deficiencies in the prior art, the object of this invention is to provide a kind of meglumine cyclic adenosine for injecta freeze-dried powder, compared with prior art, improve the safety and stability of medicine; The present invention provides its preparation method simultaneously, and technique is simple, be suitable for suitability for industrialized production.
Meglumine cyclic adenosine for injecta freeze-dried powder of the present invention, comprises following raw material: adenosine cyclophosphate and meglumine.
Meglumine cyclic adenosine for injecta freeze-dried powder of the present invention, is preferably made up of adenosine cyclophosphate and meglumine.
The mass ratio of adenosine cyclophosphate and meglumine is preferably 1:0.55-0.65.
Meglumine cyclic adenosine for injecta freeze-dried powder of the present invention, as a kind of preferred version, raw material is adenosine cyclophosphate 18.8g and meglumine 10.34-12.22g, injects water to 1500mL; Make 1000.
Meglumine cyclic adenosine for injecta freeze-dried powder of the present invention, as a kind of preferred version, raw material is adenosine cyclophosphate 37.6g and meglumine 20.65-24.44g, injects water to 1500mL; Make 1000.
Meglumine cyclic adenosine for injecta freeze-dried powder of the present invention, as one more preferably scheme, raw material is adenosine cyclophosphate 18.8g and meglumine 11.2g, injects water to 1500mL; Make 1000.
Meglumine cyclic adenosine for injecta freeze-dried powder of the present invention, as one more preferably scheme, raw material is adenosine cyclophosphate 37.6g and meglumine 22.4g, injects water to 1500mL; Make 1000.
The preparation method of meglumine cyclic adenosine for injecta freeze-dried powder of the present invention, comprises the steps:
(1) water for injection is added in material-compound tank, be cooled to less than 25 DEG C;
(2) claim meglumine, add in material-compound tank, be stirred to dissolving;
(3) claim adenosine cyclophosphate, add in material-compound tank, be stirred to dissolving, and then regulate pH to 5.5-7.0 by adding meglumine
(4) medicine after aseptic filtration carries out fill;
(5) medicine step (4) obtained loads freeze dryer and carries out freezing, dry, then rolls lid, packaging, Quan Jian, warehouse-in.
Preferably just logical sterile nitrogen from adding water for injection, pass into sterile nitrogen effectively can prevent solution and lyophilizing after product there is oxidation, improve the stability of principal agent.
(2) step first adds meglumine, and (3) step adds adenosine cyclophosphate again, and then regulates pH to 5.5-7.0 by adding meglumine, is preferably 5.5-6.0.After first adding meglumine dissolving, add adenosine cyclophosphate again, because the concentration under adenosine cyclophosphate prescription is undissolved, adenosine cyclophosphate is added again after adding meglumine, it dissolves at once, to avoid first adding after adenosine cyclophosphate insoluble in water and the phenomenon of caking, then dissolves more difficult after adding meglumine, after adenosine cyclophosphate and meglumine dissolve, then regulate pH to 5.5-7.0 by adding meglumine.Wherein: (2) step and (3) step first in molar ratio for 1:1 adds meglumine and adenosine cyclophosphate, and then regulate pH to 5.5-7.0 by adding meglumine.
In step (4), fill volume is 1.50mL, and the meglumine adenosine cycle phosphate content in meglumine adenosine cycle phosphate freeze-dried powder is 30mg or 60mg.
Freezing, drying is: medicine is loaded freeze dryer and carry out pre-freeze at-35 DEG C, maintains 3-4h; Rise-5 DEG C, medium, maintain 9-12h; Rise 10 DEG C, medium, maintain 1-2h; Rise 30 DEG C, medium, maintain 4-5h.In freeze dryer, the temperature of conduction oil is referred to as medium temperature.
In sum, the present invention has the following advantages:
(1) the present invention is in meglumine adenosine cycle phosphate freeze-dried powder preparation process, first use adenosine cyclophosphate and meglumine (preferred molar ratio is 1:1) salify, regulate between pH to 5.5-7.0 with meglumine again, improve the stability of principal agent, test through accelerated test, this product stable content in 6 months, related substance change is less, extends the storage period of preparation.
(2) stability of the present invention comparatively injection be significantly improved, and without the need to adding the materials such as glycine, mannitol, sodium chloride, sodium citrate, citric acid, sodium hydrogen phosphate, improve drug safety and stability.
(3) medicine stability of the present invention is good, and solubility is good, can recover the primary characteristic of medicinal liquid very soon, have good clinical efficacy.
(4) preparation method provided by the invention, technique is simple, be suitable for suitability for industrialized production.
Detailed description of the invention
Below in conjunction with embodiment, the present invention will be further described.
The all raw materials used in embodiment, except specified otherwise, are commercial.
Embodiment 1
Described meglumine cyclic adenosine for injecta freeze-dried powder formula consists of:
Its preparation method:
1, the water for injection of recipe quantity is added in material-compound tank, be cooled to less than 25 DEG C.
2, take the meglumine of recipe quantity, add in material-compound tank, be stirred to dissolving.
3, take the adenosine cyclophosphate of recipe quantity, add in material-compound tank, be stirred to dissolving, control ph is 5.65.
4, fill is carried out after aseptic filtration.
5, medicine loading freeze dryer carries out pre-freeze-35 DEG C, maintains 3h, rises-5 DEG C, medium, maintains 9h, rises 10 DEG C, medium, maintains 1h, rises 30 DEG C, medium, maintains 4h.
6, lid is rolled.
7, pack, Quan Jian, warehouse-in.
Embodiment 2
Its preparation method:
1, the water for injection of recipe quantity is added in material-compound tank, be cooled to less than 25 DEG C.
2, take the meglumine of recipe quantity, add in material-compound tank, be stirred to dissolving.
3, take the adenosine cyclophosphate of recipe quantity, add in material-compound tank, be stirred to dissolving, control ph is 5.75.
4, fill is carried out after aseptic filtration.
5, medicine loading freeze dryer carries out pre-freeze-35 DEG C, maintains 3.5h, rises-5 DEG C, medium, maintains 10h, rises 10 DEG C, medium, maintains 1.5h, rises 30 DEG C, medium, maintains 4.5h.
6, lid is rolled.
7, pack, Quan Jian, warehouse-in.
Embodiment 3
Its preparation method:
1, the water for injection of recipe quantity is added in material-compound tank, be cooled to less than 25 DEG C.
2, take the meglumine of recipe quantity, add in material-compound tank, be stirred to dissolving.
3, take the adenosine cyclophosphate of recipe quantity, add in material-compound tank, be stirred to dissolving, control ph is 5.90.
4, fill is carried out after aseptic filtration.
5, medicine loading freeze dryer carries out pre-freeze-35 DEG C, maintains 3.8h, rises-5 DEG C, medium, maintains 11h, rises 10 DEG C, medium, maintains 1.8h, rises 30 DEG C, medium, maintains 4.8h.
6, lid is rolled.
7, pack, Quan Jian, warehouse-in.
Embodiment 4
Its preparation method:
1, the water for injection of recipe quantity is added in material-compound tank, be cooled to less than 25 DEG C.
2, take the meglumine of recipe quantity, add in material-compound tank, be stirred to dissolving.
3, take the adenosine cyclophosphate of recipe quantity, add in material-compound tank, be stirred to dissolving, control ph is 6.00.
4, fill is carried out after aseptic filtration.
5, medicine loading freeze dryer carries out pre-freeze-35 DEG C, maintains 4h, rises-5 DEG C, medium, maintains 12h, rises 10 DEG C, medium, maintains 2h, rises 30 DEG C, medium, maintains 5h.
6, lid is rolled.
7, pack, Quan Jian, warehouse-in.
Comparative example 1
Its preparation method:
1, the water for injection of recipe quantity is added in material-compound tank, be cooled to less than 25 DEG C.
2, take the meglumine of recipe quantity, add in material-compound tank, be stirred to dissolving.
3, take the adenosine cyclophosphate of recipe quantity, add in material-compound tank, be stirred to dissolving, with 5ml sodium hydroxide (1%) solution control ph 6.00.
4, fill is carried out after aseptic filtration.
5, medicine loading freeze dryer carries out pre-freeze-35 DEG C, maintains 3h, rises-5 DEG C, medium, maintains 9h, rises 10 DEG C, medium, maintains 1h, rises 30 DEG C, medium, maintains 4h.
6, lid is rolled.
7, pack, Quan Jian, warehouse-in.
Comparative example 2
Its preparation method:
1, the water for injection of recipe quantity is added in material-compound tank, be cooled to less than 25 DEG C.
2, take the meglumine of recipe quantity, add in material-compound tank, be stirred to dissolving.
3, take the adenosine cyclophosphate of recipe quantity, add in material-compound tank, be stirred to dissolving, add sodium citrate 7g stirring and dissolving, control ph is 5.75.
4, fill is carried out after aseptic filtration.
5, medicine loading freeze dryer carries out pre-freeze-35 DEG C, maintains 3h, rises-5 DEG C, medium, maintains 9h, rises 10 DEG C, medium, maintains 1h, rises 30 DEG C, medium, maintains 4h.
6, lid is rolled.
7, pack, Quan Jian, warehouse-in.
Comparative example 3
Its preparation method:
1, the water for injection of recipe quantity is added in material-compound tank, be cooled to less than 25 DEG C.
2, take the meglumine of recipe quantity, add in material-compound tank, be stirred to dissolving.
3, take the adenosine cyclophosphate of recipe quantity, add in material-compound tank, be stirred to dissolving, add sodium hydrogen phosphate 10g stirring and dissolving, control ph is 5.90.
4, fill is carried out after aseptic filtration.
5, medicine loading freeze dryer carries out pre-freeze-35 DEG C, maintains 3h, rises-5 DEG C, medium, maintains 9h, rises 10 DEG C, medium, maintains 1h, rises 30 DEG C, medium, maintains 4h.
6, lid is rolled.
7, pack, Quan Jian, warehouse-in.
Estimation of stability is tested:
Carry out accelerated test to meglumine cyclic adenosine for injecta freeze-dried powder prepared by embodiment 1-4 and comparative example 1-3, result of the test is in table 1.Accelerated test adopts this area customary means: in calorstat, and control temperature 45 DEG C, humidity 75% accelerate 6 months.
Meglumine cyclic adenosine for injecta freeze-dried powder accelerated test result prepared by table 1 embodiment 1-4 and comparative example 1-3
Embodiment 5
A kind of meglumine cyclic adenosine for injecta freeze-dried powder formula consists of:
Its preparation method:
1, the water for injection of recipe quantity is added in material-compound tank, be cooled to less than 25 DEG C.
2, take the meglumine of recipe quantity, add in material-compound tank, be stirred to dissolving.
3, take the adenosine cyclophosphate of recipe quantity, add in material-compound tank, be stirred to dissolving, control ph is 5.68.
4, fill is carried out after aseptic filtration.
5, medicine loading freeze dryer carries out pre-freeze-35 DEG C, maintains 3h, rises-5 DEG C, medium, maintains 9h, rises 10 DEG C, medium, maintains 1h, rises 30 DEG C, medium, maintains 4h.
6, lid is rolled.
7, pack, Quan Jian, warehouse-in.
Embodiment 6
A kind of meglumine cyclic adenosine for injecta freeze-dried powder formula consists of:
Its preparation method:
1, the water for injection of recipe quantity is added in material-compound tank, be cooled to less than 25 DEG C.
2, take the meglumine of recipe quantity, add in material-compound tank, be stirred to dissolving.
3, take the adenosine cyclophosphate of recipe quantity, add in material-compound tank, be stirred to dissolving, control ph is 5.75.
4, fill is carried out after aseptic filtration.
5, medicine loading freeze dryer carries out pre-freeze-35 DEG C, maintains 3.5h, rises-5 DEG C, medium, maintains 10h, rises 10 DEG C, medium, maintains 1.5h, rises 30 DEG C, medium, maintains 4.5h.
6, lid is rolled.
7, pack, Quan Jian, warehouse-in.
Embodiment 7
A kind of meglumine cyclic adenosine for injecta freeze-dried powder formula consists of:
Its preparation method:
1, the water for injection of recipe quantity is added in material-compound tank, be cooled to less than 25 DEG C.
2, take the meglumine of recipe quantity, add in material-compound tank, be stirred to dissolving.
3, take the adenosine cyclophosphate of recipe quantity, add in material-compound tank, be stirred to dissolving, control ph is 5.85.
4, fill is carried out after aseptic filtration.
5, medicine loading freeze dryer carries out pre-freeze-35 DEG C, maintains 3.8h, rises-5 DEG C, medium, maintains 11h, rises 10 DEG C, medium, maintains 1.8h, rises 30 DEG C, medium, maintains 4.8h.
6, lid is rolled.
7, pack, Quan Jian, warehouse-in.
Embodiment 8
A kind of meglumine cyclic adenosine for injecta freeze-dried powder formula consists of:
Its preparation method:
1, the water for injection of recipe quantity is added in material-compound tank, be cooled to less than 25 DEG C.
2, take the meglumine of recipe quantity, add in material-compound tank, be stirred to dissolving.
3, take the adenosine cyclophosphate of recipe quantity, add in material-compound tank, be stirred to dissolving, control ph is 6.08.
4, fill is carried out after aseptic filtration.
5, medicine loading freeze dryer carries out pre-freeze-35 DEG C, maintains 4h, rises-5 DEG C, medium, maintains 12h, rises 10 DEG C, medium, maintains 2h, rises 30 DEG C, medium, maintains 5h.
6, lid is rolled.
7, pack, Quan Jian, warehouse-in.
Comparative example 4
A kind of meglumine cyclic adenosine for injecta freeze-dried powder formula consists of:
Its preparation method:
1, the water for injection of recipe quantity is added in material-compound tank, be cooled to less than 25 DEG C.
2, take the meglumine of recipe quantity, add in material-compound tank, be stirred to dissolving.
3, take the adenosine cyclophosphate of recipe quantity, add in material-compound tank, be stirred to dissolving, with 5ml sodium hydroxide (1%) solution control ph 6.05.
4, fill is carried out after aseptic filtration.
5, medicine loading freeze dryer carries out pre-freeze-35 DEG C, maintains 3h, rises-5 DEG C, medium, maintains 9h, rises 10 DEG C, medium, maintains 1h, rises 30 DEG C, medium, maintains 4h.
6, lid is rolled.
7, pack, Quan Jian, warehouse-in.
Comparative example 5
A kind of meglumine cyclic adenosine for injecta freeze-dried powder formula consists of:
Its preparation method:
1, the water for injection of recipe quantity is added in material-compound tank, be cooled to less than 25 DEG C.
2, take the meglumine of recipe quantity, add in material-compound tank, be stirred to dissolving.
3, take the adenosine cyclophosphate of recipe quantity, add in material-compound tank, be stirred to dissolving, add sodium citrate 7g stirring and dissolving, control ph is 5.72
4, fill is carried out after aseptic filtration.
5, medicine loading freeze dryer carries out pre-freeze-35 DEG C, maintains 3h, rises-5 DEG C, medium, maintains 9h, rises 10 DEG C, medium, maintains 1h, rises 30 DEG C, medium, maintains 4h.
6, lid is rolled.
7, pack, Quan Jian, warehouse-in.
Comparative example 6
A kind of meglumine cyclic adenosine for injecta freeze-dried powder formula consists of:
Its preparation method:
1, the water for injection of recipe quantity is added in material-compound tank, be cooled to less than 25 DEG C.
2, take the meglumine of recipe quantity, add in material-compound tank, be stirred to dissolving.
3, take the adenosine cyclophosphate of recipe quantity, add in material-compound tank, be stirred to dissolving, add sodium hydrogen phosphate 10g stirring and dissolving, control ph is 5.93
4, fill is carried out after aseptic filtration.
5, medicine loading freeze dryer carries out pre-freeze-35 DEG C, maintains 3h, rises-5 DEG C, medium, maintains 9h, rises 10 DEG C, medium, maintains 1h, rises 30 DEG C, medium, maintains 4h.
6, lid is rolled.
7, pack, Quan Jian, warehouse-in.
Estimation of stability is tested:
Carry out accelerated test to meglumine cyclic adenosine for injecta freeze-dried powder prepared by embodiment 5-8 and comparative example 4-6, result of the test is in table 2.Accelerated test adopts this area customary means: in calorstat, and control temperature 45 DEG C, humidity 75% accelerate 6 months.
Meglumine cyclic adenosine for injecta freeze-dried powder accelerated test result prepared by table 2 embodiment 5-8 and comparative example 4-6
As can be seen from table 1 and table 2, adopt meglumine to be adjusted to pH adjusting agent, in accelerated test 6 months, stabilize the oxidation that pH inhibits principal agent, improve the stability of principal agent, stable content, related substance change is less, extends the storage period of preparation.
Claims (8)
1. a meglumine cyclic adenosine for injecta freeze-dried powder, is characterized in that: comprise following raw material: adenosine cyclophosphate and meglumine.
2. meglumine cyclic adenosine for injecta freeze-dried powder according to claim 1, is characterized in that: be made up of adenosine cyclophosphate and meglumine.
3. meglumine cyclic adenosine for injecta freeze-dried powder according to claim 2, is characterized in that: the mass ratio of adenosine cyclophosphate and meglumine is 1:0.55-0.65.
4. meglumine cyclic adenosine for injecta freeze-dried powder according to claim 1, is characterized in that: raw material is adenosine cyclophosphate 18.8g and meglumine 10.34-12.22g, injects water to 1500mL; Make 1000.
5. meglumine cyclic adenosine for injecta freeze-dried powder according to claim 1, is characterized in that: raw material is adenosine cyclophosphate 37.6g and meglumine 20.65-24.44g, injects water to 1500mL; Make 1000.
6. a preparation method for the arbitrary described meglumine cyclic adenosine for injecta freeze-dried powder of claim 1-5, is characterized in that: comprise the steps:
(1) water for injection is added in material-compound tank, be cooled to less than 25 DEG C;
(2) claim meglumine, add in material-compound tank, be stirred to dissolving;
(3) claim adenosine cyclophosphate, add in material-compound tank, be stirred to dissolving, and then regulate pH to 5.5-7.0 by adding meglumine;
(4) medicine after aseptic filtration carries out fill;
(5) medicine step (4) obtained loads freeze dryer and carries out freezing, dry, then rolls lid, packaging, Quan Jian, warehouse-in.
7. the preparation method of meglumine cyclic adenosine for injecta freeze-dried powder according to claim 6, is characterized in that: in step (4), fill volume is 1.50mL, and the meglumine adenosine cycle phosphate content in meglumine adenosine cycle phosphate freeze-dried powder is 30mg or 60mg.
8. the preparation method of meglumine cyclic adenosine for injecta freeze-dried powder according to claim 6, is characterized in that: freezing, drying is: medicine is loaded freeze dryer and carry out pre-freeze at-35 DEG C, maintains 3-4h; Rise-5 DEG C, medium, maintain 9-12h; Rise 10 DEG C, medium, maintain 1-2h; Rise 30 DEG C, medium, maintain 4-5h.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN111372573A (en) * | 2017-10-09 | 2020-07-03 | 玻利萨恩科技制药有限责任公司 | Multi-ion infusion solution |
| CN111920781A (en) * | 2020-08-24 | 2020-11-13 | 瑞阳制药有限公司 | Preparation method of tedizolid phosphate preparation for injection |
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| CN1579413A (en) * | 2004-02-11 | 2005-02-16 | 江卫世 | Meglumine adenosine cyclophosphate for injection and its preparing method |
| CN1923180A (en) * | 2006-09-22 | 2007-03-07 | 江苏万邦生化医药股份有限公司 | Meglumine cyclic adenosine for injecta and its preparing process |
| CN102258531A (en) * | 2011-04-12 | 2011-11-30 | 宁辉 | Medicinal composition containing adenosine cyclophosphate and meglumine and preparation method thereof |
| CN104706655A (en) * | 2015-03-31 | 2015-06-17 | 山东北大高科华泰制药有限公司 | Meglumine adenosine cyclophosphate powder injection medicine composition for injection and preparation method thereof |
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| CN1579413A (en) * | 2004-02-11 | 2005-02-16 | 江卫世 | Meglumine adenosine cyclophosphate for injection and its preparing method |
| CN1923180A (en) * | 2006-09-22 | 2007-03-07 | 江苏万邦生化医药股份有限公司 | Meglumine cyclic adenosine for injecta and its preparing process |
| CN102258531A (en) * | 2011-04-12 | 2011-11-30 | 宁辉 | Medicinal composition containing adenosine cyclophosphate and meglumine and preparation method thereof |
| CN104706655A (en) * | 2015-03-31 | 2015-06-17 | 山东北大高科华泰制药有限公司 | Meglumine adenosine cyclophosphate powder injection medicine composition for injection and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN111372573A (en) * | 2017-10-09 | 2020-07-03 | 玻利萨恩科技制药有限责任公司 | Multi-ion infusion solution |
| CN111372573B (en) * | 2017-10-09 | 2022-04-29 | 玻利萨恩科技制药有限责任公司 | Multi-ion infusion solution |
| CN111920781A (en) * | 2020-08-24 | 2020-11-13 | 瑞阳制药有限公司 | Preparation method of tedizolid phosphate preparation for injection |
| CN111920781B (en) * | 2020-08-24 | 2024-01-09 | 瑞阳制药股份有限公司 | Preparation method of injection terozolomide disodium salt preparation |
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| CN105213329B (en) | 2018-03-27 |
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