CN1568975A - Preparing method of freeze-dried antibiotic formulation - Google Patents
Preparing method of freeze-dried antibiotic formulation Download PDFInfo
- Publication number
- CN1568975A CN1568975A CN 200410024054 CN200410024054A CN1568975A CN 1568975 A CN1568975 A CN 1568975A CN 200410024054 CN200410024054 CN 200410024054 CN 200410024054 A CN200410024054 A CN 200410024054A CN 1568975 A CN1568975 A CN 1568975A
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- CN
- China
- Prior art keywords
- effective ingredient
- imipenum
- freeze
- cilastatin
- cilastatin sodium
- 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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Abstract
The invention dislcloses the process for preparing Imipenem/Cilastatin Sodiun cryodesiccation powder preparation, which is prepared from imipenem, Cilastatin Sodium or the mixture of imipenem and Cilastatin Sodium.
Description
(1) technical field under
The invention belongs to the preparation method of imipenum/Cilastatin Sodium [Imipenem/CilastatinSodiun] lyophilized powder dosage form.
Imipenum (Imipenem) is the derivant of a thiomycin, and molecular formula is C
12H
17N
3O
4SH
2O, molecular weight are 317.36.Cilastatin Sodium (Cilastatin Sodiun) molecular formula is C
16H
25N
2NaO
5S, molecular weight are 380.44.
(2) background technology
Imipenum/Cilastatin Sodium [Imipenem/Cilastatin Sodiun] is a kind of broad-spectrum carbapenem antibiotic.Imipenum is the thiomycin derivant of first stable existence, is characterized in that fungicidal spectrum is extensive than the antibiotic of other any research.Cilastatin Sodium is a kind of specificity enzyme inhibitor, its blocking-up imipenum medicine kidney in metabolism, make it to bring into play bactericidal action.
Imipenum/Cilastatin Sodium is supplied with the injectable powder type of intravenous drip at present in China.Mainly mix and obtain with imipenum sterilized powder and Cilastatin Sodium sterilized powder and buffer salt.
Imipenem cilastatin
Owing to contain sulfur in imipenum and the Cilastatin Sodium, very easily generate with airborne combination with oxygen
The impurity of form, simultaneously to thermo-responsive, unstable in solution.Dissolved liquid status was preserved about 4 hours.
(3) summary of the invention
The present invention avoids the active component degradation in order to remedy the deficiencies in the prior art, to provide, and reduces the preparation method with the antibiotic freeze-dried formulation that contacts of air simultaneously.
The present invention is achieved through the following technical solutions:
A kind of preparation is with the method for imipenum as the pharmaceutical composition of effective ingredient, and this method comprises with said effective ingredient and one or more pharmaceutically acceptable carriers, by the mixing of cryodesiccated method.
A kind of preparation is with the method for Cilastatin Sodium as the pharmaceutical composition of effective ingredient, and this method comprises with said effective ingredient and one or more pharmaceutically acceptable carriers, by the mixing of cryodesiccated method.
A kind of preparation is with the mixture of imipenum and the Cilastatin Sodium method as the pharmaceutical composition of effective ingredient, and this method comprises with said effective ingredient and one or more pharmaceutically acceptable carriers, by the mixing of cryodesiccated method.
The said compositions of the present invention contains the said effective ingredient of 10-1500mg.
Further improvement of the present invention is: said compositions contains the said effective ingredient of 20-1200mg.
Of the present invention further the improvement is: said compositions contains the said effective ingredient of 50-1000mg.
Chemical compound imipenum/Cilastatin Sodium of the present invention comprises that in smelting treatment and prevention moderate to severe life-threatening severe infections is very effective.
Also should further recognize needs the amount of the pharmaceutical composition of the present invention of use not only to change with selected chemical compound in smelting is treated, and with being changed by the character of treatment disease and patient's age and situation, and this consumption is finally by doctor who participates in or licensed pharmacist decision, but suitable usually dosage, scope is to arrive about 750mg/kg body weight every day about 0.1, is preferably 0.5 to 100mg/kg/ days.
But needed dosage every day with suitable interval easily with single dose or the dosage that separates, for example: two, three, four or more low dose of administration obtain.
Compositions can be easily with the unit dosage form administration, and for example the per unit dosage form contains effective composition 10 to 1500mg, is 20 to 1000mg easily.
Therefore the present invention further provides a kind of pharmaceutical composition, it contains imipenum and or Cilastatin Sodium and multiple pharmaceutically acceptable carrier.Carrier with compositions in other composition be compatible and be must be " acceptable " on the harmless meaning to its receiver.Pharmaceutical composition comprises parenteral (comprise intramuscular, subcutaneous with intravenous) administration.
All methods all comprise mixes reactive compound with liquid-carrier, by lyophilization product is configured as required preparation.
Because cryodesiccated method carries out in a vacuum, so active substance is difficult for oxidation, while product water content is low, helps long preservation, and this method production opportunities for contamination reduces relatively, so the foreign body in the product is than lacking in other method.
(4) specific embodiment
Present invention will be further described by the following example, and these embodiment all do not limit the present invention going up in all senses, and all temperature all are Celsius temperatures.
Embodiment one
Under logical condition of nitrogen gas, the 50g sodium bicarbonate is added in the 325g water for injection, the 125g imipenum adds, and stirs simultaneously and obtains settled solution, solution pH value 6.5-8.5.Solution filters with 0.2 μ m filter membrane, is filled in the vial, places freeze dryer (ChristAlpha1-2) lyophilization, and bottle is chilled to-45 ℃, rises to-20 ℃ then--and 5 ℃, vacuum (0.1-0.5 millibar) drying.Behind main dry the end, temperature rises to 15 ℃, and vacuum is adjusted to 0.02 millibar, continues dry 2 hours, obtains the off-white color freeze-drying prods.
Embodiment two
Under logical condition of nitrogen gas, the 100g sodium bicarbonate is added in the 500g water for injection, the 250g Cilastatin Sodium adds, and stirs simultaneously and obtains settled solution, solution pH value 6.5-8.0.Solution filters with 0.2 μ m filter membrane, is filled in the vial, places freeze dryer (ChristAlpha1-2) lyophilization, and bottle is chilled to-40 ℃, rises to-20 ℃ then--and 5 ℃, vacuum (0.1-0.5 millibar) drying.Behind main dry the end, temperature rises to 20 ℃, and vacuum is adjusted to 0.02 millibar, continues dry 3 hours, obtains the off-white color freeze-drying prods.
Embodiment three
Under logical condition of nitrogen gas, the 50g sodium bicarbonate is added in the 500g water for injection, the 125g imipenum adds, and the 125g Cilastatin Sodium adds, and stirs simultaneously and obtains settled solution, solution pH value 6.5-8.5.Solution filters with 0.2 μ m filter membrane, is filled in the vial, places freeze dryer (Christ Alpha1-2) lyophilization, and bottle is chilled to-45 ℃, rises to-20 ℃ then--and 5 ℃, vacuum (0.1-0.5 millibar) drying.Behind main dry the end, temperature rises to 15 ℃, and vacuum is adjusted to 0.02 millibar, continues dry 3 hours, obtains the off-white color freeze-drying prods.
Claims (6)
1. one kind prepares with the method for imipenum as the pharmaceutical composition of effective ingredient, and this method comprises with said effective ingredient and one or more pharmaceutically acceptable carriers, by the mixing of cryodesiccated method.
2. one kind prepares with the method for Cilastatin Sodium as the pharmaceutical composition of effective ingredient, and this method comprises with said effective ingredient and one or more pharmaceutically acceptable carriers, by the mixing of cryodesiccated method.
3. one kind prepares with the mixture of imipenum and the Cilastatin Sodium method as the pharmaceutical composition of effective ingredient, and this method comprises with said effective ingredient and one or more pharmaceutically acceptable carriers, by the mixing of cryodesiccated method.
4. according to each method of claim 1-3, wherein said compositions contains the said effective ingredient of 10-1500mg.
5. according to the method for claim 4, wherein said compositions contains the said effective ingredient of 20-1200mg.
6. according to the method for claim 5, wherein said compositions contains the said effective ingredient of 50-1000mg.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410024054 CN1568975A (en) | 2004-04-28 | 2004-04-28 | Preparing method of freeze-dried antibiotic formulation |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410024054 CN1568975A (en) | 2004-04-28 | 2004-04-28 | Preparing method of freeze-dried antibiotic formulation |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1568975A true CN1568975A (en) | 2005-01-26 |
Family
ID=34480463
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200410024054 Pending CN1568975A (en) | 2004-04-28 | 2004-04-28 | Preparing method of freeze-dried antibiotic formulation |
Country Status (1)
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102266326A (en) * | 2011-07-14 | 2011-12-07 | 海南美兰史克制药有限公司 | Imipenem and cilastatin sodium pharmaceutical composition liposome injection |
| CN102579431A (en) * | 2011-12-16 | 2012-07-18 | 苏州二叶制药有限公司 | Preparation process of imipenem and cilastatin sodium for injection |
| CN104095847A (en) * | 2014-08-06 | 2014-10-15 | 国药集团国瑞药业有限公司 | Pharmaceutical composition containing imipenem cilastatin sodium and preparation thereof |
| CN105055169A (en) * | 2015-07-11 | 2015-11-18 | 山东新时代药业有限公司 | Preparation method of imipenem-cilastatin sodium sterile powder |
-
2004
- 2004-04-28 CN CN 200410024054 patent/CN1568975A/en active Pending
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102266326A (en) * | 2011-07-14 | 2011-12-07 | 海南美兰史克制药有限公司 | Imipenem and cilastatin sodium pharmaceutical composition liposome injection |
| CN102266326B (en) * | 2011-07-14 | 2013-07-10 | 海南美兰史克制药有限公司 | Imipenem and cilastatin sodium pharmaceutical composition liposome injection |
| CN102579431A (en) * | 2011-12-16 | 2012-07-18 | 苏州二叶制药有限公司 | Preparation process of imipenem and cilastatin sodium for injection |
| CN104095847A (en) * | 2014-08-06 | 2014-10-15 | 国药集团国瑞药业有限公司 | Pharmaceutical composition containing imipenem cilastatin sodium and preparation thereof |
| CN105055169A (en) * | 2015-07-11 | 2015-11-18 | 山东新时代药业有限公司 | Preparation method of imipenem-cilastatin sodium sterile powder |
| CN105055169B (en) * | 2015-07-11 | 2019-01-22 | 鲁南制药集团股份有限公司 | A method of preparing Imipenem and Cilasatin Sodium aseptic powdery |
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| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
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| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
| WD01 | Invention patent application deemed withdrawn after publication |