CN101856333B - Freeze-dried powder injection of cefamandole nafate and preparation method thereof - Google Patents
Freeze-dried powder injection of cefamandole nafate and preparation method thereof Download PDFInfo
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- CN101856333B CN101856333B CN2010101999749A CN201010199974A CN101856333B CN 101856333 B CN101856333 B CN 101856333B CN 2010101999749 A CN2010101999749 A CN 2010101999749A CN 201010199974 A CN201010199974 A CN 201010199974A CN 101856333 B CN101856333 B CN 101856333B
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- China
- Prior art keywords
- freeze
- dried powder
- cefamandole nafate
- cefamandole
- powder injection
- Prior art date
- 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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- 239000000843 powder Substances 0.000 title claims abstract description 48
- RRJHESVQVSRQEX-SUYBPPKGSA-N O-formylcefamandole Chemical compound CN1N=NN=C1SCC1=C(C(O)=O)N2C(=O)[C@@H](NC(=O)[C@H](OC=O)C=3C=CC=CC=3)[C@H]2SC1 RRJHESVQVSRQEX-SUYBPPKGSA-N 0.000 title claims abstract description 30
- 229960002440 cefamandole nafate Drugs 0.000 title claims abstract description 30
- 238000002347 injection Methods 0.000 title claims abstract description 15
- 239000007924 injection Substances 0.000 title claims abstract description 15
- 238000002360 preparation method Methods 0.000 title description 18
- 238000004108 freeze drying Methods 0.000 claims abstract description 30
- 238000000034 method Methods 0.000 claims abstract description 15
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 12
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims description 32
- 229910052708 sodium Inorganic materials 0.000 claims description 32
- 239000011734 sodium Substances 0.000 claims description 32
- ICZOIXFFVKYXOM-YCLOEFEOSA-M cefamandole nafate Chemical compound [Na+].CN1N=NN=C1SCC1=C(C([O-])=O)N2C(=O)[C@@H](NC(=O)[C@H](OC=O)C=3C=CC=CC=3)[C@H]2SC1 ICZOIXFFVKYXOM-YCLOEFEOSA-M 0.000 claims description 31
- 239000003814 drug Substances 0.000 claims description 21
- 229940079593 drug Drugs 0.000 claims description 18
- 238000004090 dissolution Methods 0.000 claims description 12
- 238000005374 membrane filtration Methods 0.000 claims description 8
- 239000012528 membrane Substances 0.000 claims description 6
- 238000012856 packing Methods 0.000 claims description 5
- CDBYLPFSWZWCQE-UHFFFAOYSA-L Sodium Carbonate Chemical compound [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 abstract description 14
- 229960003012 cefamandole Drugs 0.000 abstract description 11
- OLVCFLKTBJRLHI-AXAPSJFSSA-N cefamandole Chemical compound CN1N=NN=C1SCC1=C(C(O)=O)N2C(=O)[C@@H](NC(=O)[C@H](O)C=3C=CC=CC=3)[C@H]2SC1 OLVCFLKTBJRLHI-AXAPSJFSSA-N 0.000 abstract description 11
- 229910000029 sodium carbonate Inorganic materials 0.000 abstract description 7
- CURLTUGMZLYLDI-UHFFFAOYSA-N Carbon dioxide Chemical compound O=C=O CURLTUGMZLYLDI-UHFFFAOYSA-N 0.000 abstract description 6
- 239000001569 carbon dioxide Substances 0.000 abstract description 3
- 229910002092 carbon dioxide Inorganic materials 0.000 abstract description 3
- 238000001914 filtration Methods 0.000 abstract description 3
- 238000004806 packaging method and process Methods 0.000 abstract description 2
- 239000000243 solution Substances 0.000 abstract description 2
- 239000000126 substance Substances 0.000 abstract description 2
- 238000005303 weighing Methods 0.000 description 4
- 239000002994 raw material Substances 0.000 description 3
- 239000008215 water for injection Substances 0.000 description 3
- 206010001526 Air embolism Diseases 0.000 description 2
- 239000008280 blood Substances 0.000 description 2
- 210000004369 blood Anatomy 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- LSBDFXRDZJMBSC-UHFFFAOYSA-N Amide-Phenylacetic acid Natural products NC(=O)CC1=CC=CC=C1 LSBDFXRDZJMBSC-UHFFFAOYSA-N 0.000 description 1
- 241000894006 Bacteria Species 0.000 description 1
- 206010061695 Biliary tract infection Diseases 0.000 description 1
- 229930186147 Cephalosporin Natural products 0.000 description 1
- 206010011951 Decompression Sickness Diseases 0.000 description 1
- 208000005189 Embolism Diseases 0.000 description 1
- 206010019280 Heart failures Diseases 0.000 description 1
- 206010022678 Intestinal infections Diseases 0.000 description 1
- AYDQIZKZTQHYIY-UHFFFAOYSA-N OC(=O)C1(C)CC(C(O)=O)=CC=C1 Chemical compound OC(=O)C1(C)CC(C(O)=O)=CC=C1 AYDQIZKZTQHYIY-UHFFFAOYSA-N 0.000 description 1
- 206010040047 Sepsis Diseases 0.000 description 1
- 102000004377 Thiopurine S-methyltransferases Human genes 0.000 description 1
- 108090000958 Thiopurine S-methyltransferases Proteins 0.000 description 1
- 208000001435 Thromboembolism Diseases 0.000 description 1
- 210000003445 biliary tract Anatomy 0.000 description 1
- 230000017531 blood circulation Effects 0.000 description 1
- 210000000988 bone and bone Anatomy 0.000 description 1
- 229940124587 cephalosporin Drugs 0.000 description 1
- 150000001780 cephalosporins Chemical class 0.000 description 1
- 230000035606 childbirth Effects 0.000 description 1
- 208000003167 cholangitis Diseases 0.000 description 1
- 239000006184 cosolvent Substances 0.000 description 1
- 230000006837 decompression Effects 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 238000001035 drying Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 238000007710 freezing Methods 0.000 description 1
- 230000008014 freezing Effects 0.000 description 1
- 210000003128 head Anatomy 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 210000004072 lung Anatomy 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 210000003205 muscle Anatomy 0.000 description 1
- 210000003739 neck Anatomy 0.000 description 1
- 239000013618 particulate matter Substances 0.000 description 1
- 206010034674 peritonitis Diseases 0.000 description 1
- 210000003800 pharynx Anatomy 0.000 description 1
- 239000013558 reference substance Substances 0.000 description 1
- 210000002345 respiratory system Anatomy 0.000 description 1
- 238000005070 sampling Methods 0.000 description 1
- 208000013223 septicemia Diseases 0.000 description 1
- 210000003491 skin Anatomy 0.000 description 1
- 210000004872 soft tissue Anatomy 0.000 description 1
- 230000001954 sterilising effect Effects 0.000 description 1
- 238000010254 subcutaneous injection Methods 0.000 description 1
- 239000007929 subcutaneous injection Substances 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 210000000779 thoracic wall Anatomy 0.000 description 1
- 210000002229 urogenital system Anatomy 0.000 description 1
- 230000002792 vascular Effects 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
- Cephalosporin Compounds (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention relates to a freeze-dried powder injection of cefamandole nafate, which is obtained by packaging bulk pharmaceutical of the freeze-dried powder injection of cefamandole nafate according to dosage. The bulk pharmaceutical of the freeze-dried powder injection of cefamandole nafate are obtained by the following steps: dissolving the bulk pharmaceutical of cefamandole nafate with water, filtering with a film of 0.22mu m-1.0mu m, and putting the filtered solution into a freeze dryer for freeze drying. The invention adopts the filtration method to reduce the content of cefamandole in the bulk pharmaceutical, and causes the content of cefamandole nafate to be more than 95%; the process of freeze drying is carried out to obtain new bulk pharmaceutical chemicals; and the new bulk pharmaceutical are directly packaged respectively in accordance with the dosage so as to obtain the freeze-dried powder injection of cefamandole nafate. The obtained injection has good solubility, meets the requirements on all indexes in pharmacopeia, does not contain sodium carbonate and can not generate carbon dioxide, thereby solving the problems in the using process. The freeze-dried powder injection of cefamandole nafate obtained by the invention has good stability and high dissolving speed, merely contains a minute amount of cefamandole, can not influence the dissolvability, is not in need of adding sodium carbonate, and is directly packaged.
Description
Technical field
The present invention relates to a kind of cefamandole nafate freeze-dried powder, the invention still further relates to the method for preparing of this freeze-dried powder.
Background technology
The cefamandole nafate chemical formula is 7-D-(2-methanoyl phenyl acetamide)-3 [(1-methyl isophthalic acid H-tetrazolium-5 base) thiopurine methyltransferase]-3 cephems-4-carboxylic acid sodium salt, and molecular formula is C
19H
17N
6NaO
6S
2, be second generation cephalosporin, be applied to site infection such as respiratory tract, genito-urinary system, skin and soft tissue, bone and joint, pharynx otorhinolaryngology and peritonitis, septicemia etc. due to the responsive gram-negative bacteria.Biliary tract and intestinal infection there is better curative effect.
At present, mostly cefamandole nafate is the injection powder injection formulation, wherein contains a spot of cefamandole, therefore need in preparation, add sodium carbonate as cosolvent, can produce a large amount of carbon dioxide during the preparation injection, brings inconvenience to use.
Though muscle and subcutaneous injection air can not cause fatal harm to the people.But the volume air gets into blood circulation rapidly or is dissolved in free rapidly bubble, the caused thromboembolism of occluding vascular of forming of gas in the blood.The former is an air embolism, and pilosity is born in the entering of air after the phleborrhexis, during like the invasive surgery of head and neck, thoracic wall and lung and childbirth, surpasses 100ml and can cause heart failure if get into the venous air capacity rapidly; Latter's (promptly being dissolved in the free rapidly bubble that forms of gas in the blood) forwards the gas embolism that takes place in the decompression process of hypobaric to rapidly for hyperbaric environment, so claim decompression sickness again.
Summary of the invention
The objective of the invention is to overcome above-mentioned existing disadvantages of background technology part and a kind of cefamandole nafate freeze-dried powder is provided.The cefamandole nafate freeze-dried powder that the present invention obtains has reduced the content of cefamandole, and purity is high, need in preparation, not add sodium carbonate, and is easy to use.
Another object of the present invention is to provide a kind of method for preparing of above-mentioned cefamandole nafate freeze-dried powder.
The objective of the invention is to reach through following measure: the Mandokef sodium freeze-dried powder injection by Mandokef sodium freeze-drying powder crude drug, is packaged to be by using dosage; Said Mandokef sodium freeze-drying powder crude drug is obtained by purgation: the cefamandole nafate crude drug is used water dissolution, and the membrane filtration with 0.22 μ m-1.0 μ m places the freeze dryer lyophilization to obtain filtrating.
The method for preparing of Mandokef sodium freeze-dried powder injection comprises the steps: that the cefamandole nafate crude drug uses water dissolution, uses membrane filtration; Place the freeze dryer lyophilization; Get Mandokef sodium freeze-drying powder crude drug, press the using dosage packing, obtain the cefamandole nafate freeze-dried powder.
In technique scheme, said filter membrane is that the aperture is 0.22 μ m-1.0 μ m.
In technique scheme, said filter membrane is that the aperture is 0.22 μ m-0.45 μ m.
The present invention adopts filtering method, reduces the content of cefamandole in the crude drug, and cefamandole nafate is reached more than 95%, and lyophilization obtains new crude drug, directly presses the using dosage packing, obtains the cefamandole nafate freeze-dried powder.The preparation dissolubility that obtains is good, and each item index meets the pharmacopeia requirement, and carbonated sodium can not produce carbon dioxide, has solved the problem in using.
The Mandokef sodium freeze-drying powder of gained of the present invention, good stability, dissolution velocity is fast, only contains the cefamandole of trace, does not influence dissolubility, need not add sodium carbonate, the direct packaging preparation.
The related characteristics research of Mandokef sodium freeze-drying powder
1, cefamandole content
Get the Mandokef sodium freeze-drying powder and the crude drug contrast of above preparation; Detect the content of cefamandole by the method for pharmacopeia requirement; The result sees table 1; The content of cefamandole is merely 0.31% in the sample of this patent preparation, and the content of cefamandole is 7.8% in the reference substance, and the pharmacopeia regulation can not be greater than 9.5%.
Table 1 cefamandole content detection result:
2, the dissolubility of Mandokef sodium freeze-drying powder
Get the Mandokef sodium freeze-drying powder and the crude drug contrast of above preparation, clarity, visible foreign matters, the particulate matter of doing solution by the pharmacopeia requirement detect, and all meet standards of pharmacopoeia.
Get Mandokef sodium freeze-drying powder and the crude drug and the crude drug+sodium carbonate contrast of above preparation, compare three's dissolution velocity, result such as table 2, the dissolubility of the Mandokef sodium freeze-drying powder crude drug of the present invention's preparation obviously improves.
Table 2 dissolution velocity relatively
| Dissolution velocity | |
| The present invention prepares sample | 30s |
| The marketable material medicine | Greater than 30min |
| Marketable material medicine+sodium carbonate | 57s |
3, the stability of Mandokef sodium freeze-drying powder
The Mandokef sodium freeze-drying powder of getting the inventive method preparation carries out high wet test; And do contrast with commercial cefamandole nafate powder pin; In 40 ℃ of underlying relative humiditys are 75% climatic chamber; Placed 10 days, respectively at sampling calibrating in the 2nd, 4,6,8,10 day, result and 0 day sample survey result were relatively.The result sees table 1
Table 1 is at 40 ℃, and humidity is stability, the hygroscopicity under 75% condition, the clarity test result:
4, cefamandole nafate freeze-dried powder
Get the cefamandole nafate freeze-dried powder and the contrast of commercially available Mandokef sodium powder-needle preparation of above preparation.Quality all meets the pharmacopeia requirement.Dissolved the time, the preparation of the present invention's preparation dissolves rapidly, does not produce bubble.And produce a large amount of bubbles during the dissolving of commercially available Mandokef sodium powder-needle preparation.
The specific embodiment
The Mandokef sodium freeze-dried powder injection, it is with Mandokef sodium freeze-drying powder crude drug, presses the using dosage packing, obtains the cefamandole nafate freeze-dried powder; The method for preparing of said Mandokef sodium freeze-drying powder crude drug is: the cefamandole nafate crude drug is used water dissolution, and the membrane filtration with 0.22 μ m-1.0 μ m places the freeze dryer lyophilization to obtain filtrating.
The method for preparing of Mandokef sodium freeze-dried powder injection comprises the steps: that the cefamandole nafate crude drug uses water dissolution, uses membrane filtration; Place the freeze dryer lyophilization; Get Mandokef sodium freeze-drying powder crude drug, press the using dosage packing, obtain the cefamandole nafate freeze-dried powder.Said filter membrane is that the aperture is 0.22 μ m-1.0 μ m.Said filter membrane is that the aperture is 0.22 μ m-0.45 μ m (preferred version).
Embodiment 1
Take by weighing Mandokef sodium raw materials 200g, place the 100ml beaker, add the 50ml water dissolution.With the membrane filtration of 0.45 μ m, the filtrating lyophilizing gets the Mandokef sodium freeze-drying powder.Be dissolved in the water for injection fully in the 25s.
Embodiment 2
Take by weighing Mandokef sodium raw materials 2000g, place the 1000ml beaker, add the 500ml water dissolution.With the membrane filtration of 0.22 μ m, the filtrating lyophilizing gets the Mandokef sodium freeze-drying powder.Be dissolved in the water for injection fully in the 20s.
Embodiment 3
Take by weighing Mandokef sodium raw materials 2000g, place the 1000ml beaker, add the 500ml water dissolution.With the membrane filtration of 1.0 μ m, the filtrating lyophilizing gets the Mandokef sodium freeze-drying powder.Be dissolved in the water for injection fully in the 30s.
Embodiment 3
It is some to take by weighing the Mandokef sodium freeze-drying powder, pulverizes the back and crosses 60 mesh sieves, in sterilizing room under 100 grades of conditions, is undertaken aseptic subpackagedly by the loading amount requirement, promptly gets medicine cefamandole nafate for inj freeze-dried powder.Loading amount can be but be not only every bottle of 0.5g, 1g, 2g.
Embodiment 4
The freeze-dry process of Mandokef sodium freeze-drying powder is following, but is not limited only to following scheme:
The medicinal liquid quick freezing is to-40 ℃, and condenser is cooled to-50 ℃ then, is evacuated to below the 10Pa, begins to heat up; Phase I :-40 ℃～-30 ℃, 8 hours time, second stage :-30 ℃～0 ℃; 6 hours time, the phase III: 0 ℃～30 ℃, 7 hours time.30 ℃ of continued are incubated 3 hours.
Claims (2)
1. the method for preparing of Mandokef sodium freeze-dried powder injection; It is characterized in that, comprise the steps: cefamandole nafate is used water dissolution, with 0.22 μ m-1.0 μ m membrane filtration; Filtrating is placed the freeze dryer lyophilization; Get Mandokef sodium freeze-drying powder crude drug, press the using dosage packing then, obtain the cefamandole nafate freeze-dried powder; Said lyophilization condition is: filter membrane is frozen into-40 ℃, condenser is cooled to-50 ℃ then, is evacuated to below the 10Pa, begins to heat up; Phase I :-40～-30 ℃, 8 hours time, second stage :-30 ℃～0 ℃; 6 hours time, the phase III: 0 ℃～30 ℃, 7 hours time; 30 ℃ of continued are incubated 3 hours.
2. method for preparing according to claim 1 is characterized in that said filter membrane aperture is 0.22 μ m-0.45 μ m.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2010101999749A CN101856333B (en) | 2010-06-10 | 2010-06-10 | Freeze-dried powder injection of cefamandole nafate and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2010101999749A CN101856333B (en) | 2010-06-10 | 2010-06-10 | Freeze-dried powder injection of cefamandole nafate and preparation method thereof |
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| Publication Number | Publication Date |
|---|---|
| CN101856333A CN101856333A (en) | 2010-10-13 |
| CN101856333B true CN101856333B (en) | 2012-02-22 |
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| CN2010101999749A Expired - Fee Related CN101856333B (en) | 2010-06-10 | 2010-06-10 | Freeze-dried powder injection of cefamandole nafate and preparation method thereof |
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| CN106511281A (en) * | 2016-09-30 | 2017-03-22 | 华北制药河北华民药业有限责任公司 | Preparation method of Cefamandole Nafate powder injection for injection |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101219117A (en) * | 2007-08-14 | 2008-07-16 | 山东罗欣药业股份有限公司 | Cefamandole nafate powder injection, production method of powder injection and raw machine thereof |
| CN101279979A (en) * | 2008-06-03 | 2008-10-08 | 海南本创医药科技有限公司 | Separation and purification method of cefamandole nafate and preparation of cefathiamidine freeze-dried injectable powder |
| CN101637456A (en) * | 2009-08-18 | 2010-02-03 | 海南永田药物研究院有限公司 | Suspension powder injection of cefamandole nafate and new application thereof |
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2010
- 2010-06-10 CN CN2010101999749A patent/CN101856333B/en not_active Expired - Fee Related
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101219117A (en) * | 2007-08-14 | 2008-07-16 | 山东罗欣药业股份有限公司 | Cefamandole nafate powder injection, production method of powder injection and raw machine thereof |
| CN101279979A (en) * | 2008-06-03 | 2008-10-08 | 海南本创医药科技有限公司 | Separation and purification method of cefamandole nafate and preparation of cefathiamidine freeze-dried injectable powder |
| CN101637456A (en) * | 2009-08-18 | 2010-02-03 | 海南永田药物研究院有限公司 | Suspension powder injection of cefamandole nafate and new application thereof |
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