CN105640897A - Ceftaroline fosamil pharmaceutical composition for injection - Google Patents
Ceftaroline fosamil pharmaceutical composition for injection Download PDFInfo
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- CN105640897A CN105640897A CN201410632129.4A CN201410632129A CN105640897A CN 105640897 A CN105640897 A CN 105640897A CN 201410632129 A CN201410632129 A CN 201410632129A CN 105640897 A CN105640897 A CN 105640897A
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- CN
- China
- Prior art keywords
- injection
- ceftaroline fosamil
- water
- pharmaceutical composition
- mannitol
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- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Links
- 229960004828 ceftaroline fosamil Drugs 0.000 title claims abstract description 50
- ZCCUWMICIWSJIX-NQJJCJBVSA-N ceftaroline fosamil Chemical compound S([C@@H]1[C@@H](C(N1C=1C([O-])=O)=O)NC(=O)\C(=N/OCC)C=2N=C(NP(O)(O)=O)SN=2)CC=1SC(SC=1)=NC=1C1=CC=[N+](C)C=C1 ZCCUWMICIWSJIX-NQJJCJBVSA-N 0.000 title claims abstract description 49
- 239000008194 pharmaceutical composition Substances 0.000 title claims abstract description 23
- 238000002347 injection Methods 0.000 title claims abstract description 22
- 239000007924 injection Substances 0.000 title claims abstract description 22
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims abstract description 69
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims abstract description 21
- 229930195725 Mannitol Natural products 0.000 claims abstract description 21
- 235000010355 mannitol Nutrition 0.000 claims abstract description 21
- 239000000594 mannitol Substances 0.000 claims abstract description 21
- 239000000843 powder Substances 0.000 claims abstract description 9
- 238000002360 preparation method Methods 0.000 claims abstract description 9
- 230000008901 benefit Effects 0.000 claims abstract description 7
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 33
- 239000008215 water for injection Substances 0.000 claims description 25
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 claims description 23
- 239000000243 solution Substances 0.000 claims description 16
- 239000003814 drug Substances 0.000 claims description 10
- 238000004108 freeze drying Methods 0.000 claims description 10
- 239000000543 intermediate Substances 0.000 claims description 10
- 238000010792 warming Methods 0.000 claims description 10
- 230000008014 freezing Effects 0.000 claims description 9
- 238000007710 freezing Methods 0.000 claims description 9
- 239000007788 liquid Substances 0.000 claims description 8
- 238000003756 stirring Methods 0.000 claims description 6
- 239000003610 charcoal Substances 0.000 claims description 5
- 210000004907 gland Anatomy 0.000 claims description 5
- 238000009413 insulation Methods 0.000 claims description 5
- 238000011068 loading method Methods 0.000 claims description 5
- 238000005259 measurement Methods 0.000 claims description 5
- 229940105082 medicinal charcoal Drugs 0.000 claims description 5
- 239000012535 impurity Substances 0.000 abstract description 3
- 239000000047 product Substances 0.000 description 16
- 238000000034 method Methods 0.000 description 11
- 238000001035 drying Methods 0.000 description 10
- 238000004821 distillation Methods 0.000 description 6
- 238000000859 sublimation Methods 0.000 description 6
- 230000008022 sublimation Effects 0.000 description 6
- 239000000126 substance Substances 0.000 description 5
- 238000012360 testing method Methods 0.000 description 5
- 238000005516 engineering process Methods 0.000 description 3
- 239000002671 adjuvant Substances 0.000 description 2
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 2
- 229910052782 aluminium Inorganic materials 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 238000002474 experimental method Methods 0.000 description 2
- 239000012467 final product Substances 0.000 description 2
- 238000005286 illumination Methods 0.000 description 2
- 230000007774 longterm Effects 0.000 description 2
- 239000000203 mixture Substances 0.000 description 2
- 238000011160 research Methods 0.000 description 2
- 238000001179 sorption measurement Methods 0.000 description 2
- ITHCSGCUQDMYAI-ZMIZWQJLSA-N 2-carboxy-D-arabinitol 1,5-bisphosphate Chemical compound OP(=O)(O)OC[C@@H](O)[C@@H](O)[C@](O)(COP(O)(O)=O)C(O)=O ITHCSGCUQDMYAI-ZMIZWQJLSA-N 0.000 description 1
- 206010003694 Atrophy Diseases 0.000 description 1
- 201000001178 Bacterial Pneumonia Diseases 0.000 description 1
- RJQXTJLFIWVMTO-TYNCELHUSA-N Methicillin Chemical compound COC1=CC=CC(OC)=C1C(=O)N[C@@H]1C(=O)N2[C@@H](C(O)=O)C(C)(C)S[C@@H]21 RJQXTJLFIWVMTO-TYNCELHUSA-N 0.000 description 1
- 102100021486 Protein S100-G Human genes 0.000 description 1
- 101710122252 Protein S100-G Proteins 0.000 description 1
- 241000191967 Staphylococcus aureus Species 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 230000001133 acceleration Effects 0.000 description 1
- 230000001154 acute effect Effects 0.000 description 1
- 239000003463 adsorbent Substances 0.000 description 1
- -1 after filtration Substances 0.000 description 1
- 230000037444 atrophy Effects 0.000 description 1
- 230000001580 bacterial effect Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000003115 biocidal effect Effects 0.000 description 1
- 230000005540 biological transmission Effects 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 230000000052 comparative effect Effects 0.000 description 1
- 239000000356 contaminant Substances 0.000 description 1
- 238000004090 dissolution Methods 0.000 description 1
- 238000001647 drug administration Methods 0.000 description 1
- 239000002158 endotoxin Substances 0.000 description 1
- 150000002148 esters Chemical class 0.000 description 1
- 230000005496 eutectics Effects 0.000 description 1
- 238000001914 filtration Methods 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 239000008187 granular material Substances 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 238000011835 investigation Methods 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 239000011159 matrix material Substances 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 229960003085 meticillin Drugs 0.000 description 1
- 230000007935 neutral effect Effects 0.000 description 1
- 238000004806 packaging method and process Methods 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 239000002510 pyrogen Substances 0.000 description 1
- 238000000275 quality assurance Methods 0.000 description 1
- 230000000630 rising effect Effects 0.000 description 1
- 238000005070 sampling Methods 0.000 description 1
- 230000006641 stabilisation Effects 0.000 description 1
- 238000013112 stability test Methods 0.000 description 1
- 238000011105 stabilization Methods 0.000 description 1
- 238000012546 transfer Methods 0.000 description 1
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- Medicinal Preparation (AREA)
Abstract
The present invention relates to a stable and safe ceftaroline fosamil pharmaceutical composition for injection, and a preparation method thereof, preferably freeze-dried powder. According to the present invention, the ceftaroline fosamil pharmaceutical composition mainly comprises an active component ceftaroline fosamil, mannitol, and sodium hydroxide; and the obtained ceftaroline fosamil pharmaceutical composition for injection has characteristics of stable pH value, low impurity content, effectively-improved treatment effect, cost reducing, and high benefit creating.
Description
Technical field
The invention belongs to pharmaceutical technology field, be specifically related to stable safe injection Ceftaroline Fosamil pharmaceutical composition and preparation method thereof.
Background technology
His Lorraine ester Zinforo(active component ceftarolinefosamil of cephalo), a kind of injection antibiotic, for treating the acquired bacterial pneumonia in Adults Community (CABP) and acute bacterial skin and skin structure infection (ABSSSI), including methicillin-resistant staphylococcus aureus (MRSA).
Its structural formula is:
The injection Ceftaroline Fosamil pharmaceutical composition that the present invention obtains on the basis of great many of experiments, has the advantage that: safety is high, and maximum contaminant is less than 0.1%; Good stability, even if room temperature preserves, reliable in quality.
Summary of the invention
In order to overcome the drawbacks described above of prior art, thering is provided a kind of stable Ceftaroline Fosamil pharmaceutical composition, the present inventor have passed through further investigation, it was surprisingly found that, select specific adjuvant (sodium hydroxide), it is possible to obtain the Ceftaroline Fosamil pharmaceutical composition of good stability, effective and safe.
Therefore, it is an object of the present invention to provide that a kind of formulation and technology is simple, the injection Ceftaroline Fosamil pharmaceutical composition of good stability, effective and safe, this pharmaceutical composition contains Ceftaroline Fosamil, mannitol and sodium hydroxide. The Ceftaroline Fosamil pharmaceutical composition of the present invention, it is the pharmaceutical preparation being suitable for drug administration by injection, be preferably lyophilized injectable powder, and when this injection is lyophilized injectable powder, its by Ceftaroline Fosamil, mannitol, sodium hydroxide, inject and prepare freeze-dried technique with water and make.
It is a further object to provide one and be easy to industrialized mass, the preparation method of the simple Ceftaroline Fosamil pharmaceutical composition of technique.
The Ceftaroline Fosamil pharmaceutical composition of the present invention, wherein the prescription of compositions consists of: Ceftaroline Fosamil, mannitol, sodium hydroxide and water for injection.
Ceftaroline Fosamil 50-100g
Mannitol 20-40g
Sodium hydroxide 7-15g
Water for injection adds to 1.5-3L
Make 1000
Prescription is preferably: Ceftaroline Fosamil, mannitol, sodium hydroxide and water for injection, and the weight ratio of each component is: Ceftaroline Fosamil: mannitol: sodium hydroxide: water=50-100:20-40:7-15:1500-3000.
Preferred preparation method is:
1) joining in water for injection by the sodium hydroxide of recipe quantity, Ceftaroline Fosamil, mannitol, water for injection temperature is in 10 �� 5 DEG C, so as to dissolve, benefit adds to the full amount of water for injection;
2) according to the 0.1%g/ml of medicine liquid volume amount in the solution that step 1) prepares, add medicinal charcoal, after stirring 15 minutes, filter;
3) intermediates content measures;
4) according to intermediates content measurement result, regulate loading amount, fill, partly jump a queue;
5) medicinal liquid lyophilization step 4) obtained, aseptically gland, aluminum seals, and to obtain final product.
Containing active component Ceftaroline Fosamil and adjuvant mannitol, sodium hydroxide in the Ceftaroline Fosamil lyophilized injectable powder of the present invention.
Active component Ceftaroline Fosamil in prescription is readily soluble in water, so making injection, research process finds, in neutral solution, Ceftaroline Fosamil is unstable, placement process easily there is related substance increase, solution colour easily turns yellow, have impact on the safety of the quality of medicine and clinical practice, find through lot of experiments research, add sodium hydroxide available buffer pH value and medicinal liquid is played Stabilization, not only solving in the storage of injection has related substance to exceed standard, the problem of solution changes color, also solve freeze-dried powder has related substance to increase simultaneously in storage, ensure that the quality of medicine and stable.
The character of the technique of frozen preparation, product quality and drug solution has close relationship, freezing dry process is the process of a dynamic change, different drug solutions needs the refrigerating process to refrigerating process, dry run, three processes of vacuum control to be correspondingly improved, just can draw standard compliant product, to this, inventor pays all effort, obtains following technique.
Preparing Ceftaroline Fosamil pharmaceutical composition for realizing the present invention, the technical scheme of employing is:
1) joining in water for injection by the sodium hydroxide of recipe quantity, Ceftaroline Fosamil, mannitol, water for injection temperature is in 10 �� 5 DEG C, so as to dissolve, benefit adds to the full amount of water for injection;
2) according to the 0.1%g/ml of medicine liquid volume amount in the solution that step 1) prepares, add medicinal charcoal, after stirring 15 minutes, filter;
3) intermediates content measures;
4) according to intermediates content measurement result, regulate loading amount, fill, partly jump a queue;
5) medicinal liquid lyophilization step 4) obtained, aseptically gland, aluminum seals, and to obtain final product.
It is characterized in that, described lyophilization, the vial that fill is good is put into the freeze drying box being cooled to 5 DEG C, it is cooled to rapidly-40 DEG C, freezing 3 hours of insulation, then evacuation, it is warming up to-5 DEG C in 3 hours, the time maintaining-5 DEG C was 10 hours, was warming up to 40 DEG C at 3 hours, and the time maintaining 40 DEG C is 6 hours.
Above-mentioned steps 1) described in course of dissolution in, first sodium hydroxide and Ceftaroline Fosamil are joined in the water for injection of 10 �� 5 DEG C after fully dissolving, add mannitol, both are uniformly distributed in the solution, finally obtain lyophilisation product redissolution type good.
Above-mentioned steps 2) in the 0.1%g/ml that consumption is joined liquor capacity of activated carbon.
The impact on product of the consumption of activated carbon, if activated carbon dosage is too many, the active component in adsorbent solution can be caused, the productivity making its product reduces, if activated carbon dosage is very little, it is impossible to decoloured by solution completely, pyrogen removal, the removal of impurity, and then affect the performances such as the quality of product, purity, so the selection of the consumption of activated carbon should be considered.
The inventors discovered that, in CPT ester solution, add the activated carbon of 0.1%g/ml, now principal agent Ceftaroline Fosamil be there's almost no adsorption by activated carbon, after filtration, solution colour is colorless cleared solution, and after activated carbon adsorption, Ceftaroline Fosamil carries out having related substance to detect, and wherein impurity is almost without change, bacterial endotoxin is qualified, refers to experimental example 1.
Above-mentioned steps 2) in, after adding activated carbon, stir 15 minutes.
Above-mentioned steps 5) in, freezing dry process divides three phases, freezing, distillation, dry run.
In the freezing dry process of Ceftaroline Fosamil pharmaceutical composition of the present invention, consider frozen product dry run, the mode of appearance of product and the content of moisture, make the fast color of product be refrigerated to-40 DEG C, freezing 3 hours of insulation.
After Pharmaceutical freeze, starting vacuum machine and be evacuated to 15Pa, close fridge, be warming up to-5 DEG C to medicine in 3 hours, the time maintaining-5 DEG C is 10 hours.
The choice relation of sublimation temperature, to the speed of distillation, selects temperature to-5 DEG C, during distillation, upper materials takes the lead in drying, if the rising of its temperature is too fast, it is possible to reach disintegrate temperature, porous matrix rigidity reduces, coming off occurs in granule in drying layer, and can close the microporous filter membrane of drying nest, stops the carrying out of distillation, rate of sublimation is made to slow down, even make underclad portion slightly atrophy, affect the content of the residual moisture of goods, cause that solubility, stability and clarity are deteriorated simultaneously.
Pressure during distillation is 15Pa, rather than lower, although this is because pressure is low is conducive to the life of ice in product, but due to pressure too low time, heat transfer is unfavorable, and product not easily obtains heat, and rate of sublimation reduces on the contrary. But, when pressure is too high, in product, the rate of sublimation of ice slows down, and product caloric receptivity will reduce, and then the temperature of product self rises, when higher than temperature of eutectic point, product will melt, and causes lyophilizing failure, therefore, being 15Pa by pressure set, the transmission being both beneficial to heat is conducive to the carrying out of distillation.
During drying going out the process of Bound moisture, after sublimation drying, also remaining part absorption water and Bound moisture, these water are not frozen, can not remove in primary drying. Temperature was warming up to 40 DEG C at 3 hours by the present invention after sublimation drying, and the time maintaining 40 DEG C is 6 hours, and the freeze-drying prods moisture of gained is lower than 3%, as well known to those skilled in the art, and the moisture of freeze-drying prods is more low, and its stability is more good.
Detailed description of the invention:
Below in conjunction with embodiment, the present invention is described further, makes professional and technical personnel in the field be better understood from the present invention. Embodiment is only indicative, is in no way to be construed as the scope that it is intended to limit the present invention in any manner.
Embodiment 1
Ceftaroline Fosamil 50g
Mannitol 20g
Sodium hydroxide 7g
Water for injection adds to 1.5L
Make 1000
Preparation method is:
1) joining in water for injection by the sodium hydroxide of recipe quantity, Ceftaroline Fosamil, mannitol, water for injection temperature is in 10 �� 5 DEG C, so as to dissolve, benefit adds to the full amount of water for injection;
2) according to the 0.1%g/ml of medicine liquid volume amount in the solution that step 1) prepares, add medicinal charcoal, after stirring 15 minutes, filter;
3) intermediates content measures;
4) according to intermediates content measurement result, regulate loading amount, fill, partly jump a queue;
5) vial that fill is good is put into the freeze drying box being cooled to 5 DEG C, it is cooled to rapidly-40 DEG C, freezing 3 hours of insulation, then evacuation, being warming up to-5 DEG C in 3 hours, the time maintaining-5 DEG C is 10-15 hour, is warming up to 40 DEG C at 3 hours, the time maintaining 40 DEG C is 3-6 hour, tamponade;
6) gland, obtains injection Ceftaroline Fosamil pharmaceutical composition.
Embodiment 2
Ceftaroline Fosamil 100g
Mannitol 40g
Sodium hydroxide 15g
Water for injection adds to 3L
Make 1000
Preparation method is:
1) joining in water for injection by the sodium hydroxide of recipe quantity, Ceftaroline Fosamil, mannitol, water for injection temperature is in 10 �� 5 DEG C, so as to dissolve, benefit adds to the full amount of water for injection;
2) according to the 0.1%g/ml of medicine liquid volume amount in the solution that step 1) prepares, add medicinal charcoal, after stirring 15 minutes, filter;
3) intermediates content measures;
4) according to intermediates content measurement result, regulate loading amount, fill, partly jump a queue;
5) vial that fill is good is put into the freeze drying box being cooled to 5 DEG C, it is cooled to rapidly-40 DEG C, freezing 3 hours of insulation, then evacuation, being warming up to-5 DEG C in 3 hours, the time maintaining-5 DEG C is 10-15 hour, is warming up to 40 DEG C at 3 hours, the time maintaining 40 DEG C is 3-6 hour, tamponade;
6) gland, obtains injection Ceftaroline Fosamil pharmaceutical composition.
Experimental example 1
Testing according to 2010 editions two annex XIXC stability test guidelines of Chinese Pharmacopoeia, the key index to embodiment: character, visible foreign matters, clarity, have related substance and content to test, testing result is in Table 1,2.
Under influence factor's high temperature (temperature 60 C �� 2 DEG C) illumination (illumination 4500 �� 500LX) result of the test is shown in.
Take sample, it is accelerated (when temperature is 40 DEG C �� 2 DEG C, relative humidity is 75% �� 5%) 6 months and long-term (when temperature is 25 DEG C �� 2 DEG C, relative humidity is 60% �� 10%) experimental study in 24 months by paid packaging, detecting according to table 3 point in time sampling, result is as follows.
Every key index is without significant change in influence factor, acceleration, long term test for product prepared by the present invention, and especially clarity and visible foreign matters item are better than comparative example, quality assurance, good stability.
Claims (4)
1. the Ceftaroline Fosamil pharmaceutical composition of an injection, it is characterized in that this injection is lyophilized injectable powder, wherein each components by weight is: Ceftaroline Fosamil, mannitol, sodium hydroxide and water for injection, and the weight ratio of each component is: Ceftaroline Fosamil: mannitol: sodium hydroxide: water=50-100:20-40:7-15:1500-3000, prepare 1000, composed as follows:
Ceftaroline Fosamil 50-100g
Mannitol 20-40g
Sodium hydroxide 7-15g
Water for injection adds to 1.5-3L.
2. the Ceftaroline Fosamil pharmaceutical composition of injection according to claim 1, it is characterised in that this injection is lyophilized injectable powder, prepares 1000, composed as follows:
Ceftaroline Fosamil 50g
Mannitol 20g
Sodium hydroxide 7g
Water for injection adds to 1.5L.
3. the Ceftaroline Fosamil pharmaceutical composition of injection according to claim 1, it is characterised in that this injection is lyophilized injectable powder, prepares 1000, composed as follows:
Ceftaroline Fosamil 100g
Mannitol 40g
Sodium hydroxide 15g
Water for injection adds to 3L.
4. the preparation method of the Ceftaroline Fosamil pharmaceutical composition of injection according to claim 1, wherein the preparation method of lyophilized injectable powder comprises the following steps:
1)Joining in water for injection by the sodium hydroxide of recipe quantity, Ceftaroline Fosamil, mannitol, water for injection temperature is in 10 �� 5 DEG C, so as to dissolve, benefit adds to the full amount of water for injection;
2)According to the 0.1%g/ml of medicine liquid volume amount in the solution that step 1) prepares, add medicinal charcoal, after stirring 15 minutes, filter;
3)Intermediates content measures;
4)According to intermediates content measurement result, regulate loading amount, fill, partly jump a queue;
5)The vial that fill is good is put into the freeze drying box being cooled to 5 DEG C, is cooled to rapidly-40 DEG C, freezing 3 hours of insulation, then evacuation, was warming up to-5 DEG C in 3 hours, and the time maintaining-5 DEG C is 10-15 hour, be warming up to 40 DEG C at 3 hours, the time maintaining 40 DEG C is 3-6 hour, tamponade;
6)Gland, obtains injection Ceftaroline Fosamil pharmaceutical composition.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410632129.4A CN105640897A (en) | 2014-11-12 | 2014-11-12 | Ceftaroline fosamil pharmaceutical composition for injection |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410632129.4A CN105640897A (en) | 2014-11-12 | 2014-11-12 | Ceftaroline fosamil pharmaceutical composition for injection |
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| Publication Number | Publication Date |
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| CN105640897A true CN105640897A (en) | 2016-06-08 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN201410632129.4A Pending CN105640897A (en) | 2014-11-12 | 2014-11-12 | Ceftaroline fosamil pharmaceutical composition for injection |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106491537A (en) * | 2016-12-02 | 2017-03-15 | 瑞阳制药有限公司 | Injectable sterile powder comprising Ceftaroline Fosamil and preparation method thereof |
-
2014
- 2014-11-12 CN CN201410632129.4A patent/CN105640897A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106491537A (en) * | 2016-12-02 | 2017-03-15 | 瑞阳制药有限公司 | Injectable sterile powder comprising Ceftaroline Fosamil and preparation method thereof |
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Application publication date: 20160608 |