CN101966152A - Cefpiramide composite - Google Patents
Cefpiramide composite Download PDFInfo
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- CN101966152A CN101966152A CN 201010524972 CN201010524972A CN101966152A CN 101966152 A CN101966152 A CN 101966152A CN 201010524972 CN201010524972 CN 201010524972 CN 201010524972 A CN201010524972 A CN 201010524972A CN 101966152 A CN101966152 A CN 101966152A
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- cefpiramide
- sodium carbonate
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Abstract
The invention relates to a cefpiramide composite which is used for the cefpiramide powder-injection in the medicinal manufacture field. The invention discloses the following characteristic of the cefpiramide composite: the composite for the cefpiramide powder-injection which is prepare by the conventional production technology of powder-injection contains two or more of the following components: (a) sterile cefpiramide, (b) sterile sodium carbonate; and (c) sterile anhydrous glucose, dextrose monohydrate, sodium chloride, mannitol, sorbitol, anhydrous lactose or lactose monohydrate, wherein the weight ratio of the component (a) to the component (b) and the component (c) is 1:0.15-0.4:0.03-4.0. The invention has the advantages that the problem that the cefpiramide for injection on the market is difficult to dissolve, especially at a low temperature is solved; the operation of the nurse is easy; and the raw materials are accessible and the drug stability is good.
Description
Technical field
The present invention relates to pharmaceutical industry, particularly be applicable to and make injection cefpiramide injectable powder.
Background technology
Cefpiramide is a third generation cephalosporin, and has a broad antifungal spectrum has been widely used in the clinical treatment bacterial infection, determined curative effect, and untoward reaction is rare and slight.Cefpiramide is water insoluble, is that form dissolving back with its sodium salt is by intramuscular injection, intravenous injection or intravenous drip administration during clinical use.
The injection cefpiramide powder pin of listing is the compositions of cefpiramide and sodium carbonate at present, operate insoluble shortcoming routinely with transfusions such as electrolyte solution or Glucose Liquids when mainly having clinical use, as when 25 ℃ of left and right sides, need 2～3 minutes ability to dissolve fully, if sticking wall conglomeration is serious during dissolving, then need 3～5 minutes, during low temperature (as 5～10 ℃) more indissoluble separate, even above 5 minutes.Just because of the difficult problem of dissolving, seriously limited the use clinically of injection cefpiramide, except that summer temperature when higher there is certain use in hospital, it is considerably less that the low more indissoluble of Yin Wendu in other season is separated use amount, its clinical use amount is less than 5% of cefpiramide sodium for injection.
Two kinds that disclose among the Chinese patent CN1634074 in the cefpiramide compositions consist of cefpiramide and cosolvent, and the ratio that reaches between the two is 1:0.1～0.6, the good stability of this kind compositions, but room temperature is preserved.This compositions is that mix homogeneously makes with cefpiramide (it is following to produce particle size range 50 μ m commonly used at present) with sodium carbonate (producing particle size range commonly used at present is 100～150 orders), but this compositions fails to solve insoluble problem.
Disclose among the Chinese patent 201010246519.x and adopted the method for spray drying and comminution by gas stream to prepare ultra-fine sodium carbonate, the particle size range of ultra-fine sodium carbonate is below the 20 μ m.The compositions that adopts ultra-fine sodium carbonate and cefpiramide mix homogeneously to make, its dissolution velocity is faster than the disclosed compositions of Chinese patent CN163407, but temperature when low dissolving still need about 1 minute, dissolution velocity is still undesirable.Simultaneously, the preparation cost height of ultra-fine sodium carbonate, energy consumption is big, is unfavorable for production application, the production of especially aseptic ultra-fine sodium carbonate, quality be cannot say for sure to demonstrate,prove.
Summary of the invention
The purpose of this invention is to provide the cefpiramide compositions, raw material is easy to get, and is simple to operate, and clinical use said composition dissolving is rapid, and medicine stability is good.
Technical scheme of the present invention is to be made up of following composition by the compositions that the packing of powder pin conventional production process makes injection cefpiramide injectable powder:
(a) aseptic cefpiramide;
(b) sterile sodium carbonate;
(c) aseptic anhydrous glucose, Dextrose Monohydrate, sodium chloride, mannitol, sorbitol, Lactis Anhydrous or lactose monohydrate and be wherein two kinds of compositions or the compositions of multiple composition;
The weight ratio of the above composition is (a): (b): (c)=and 1:0.15～0.4:0.03～4.0.
In the above (C) Dextrose Monohydrate, anhydrous glucose are arranged, each weight ratio of forming is (a) in the cefpiramide compositions of being formed: (b): Dextrose Monohydrate (or anhydrous glucose)=1:0.16～0.23:0.1～1.0.
Preparation method of the present invention is: take by weighing (b) and (c) mix homogeneously according to the above ratio, add (a) according to the above ratio, remix is even, presses the packing of powder pin conventional production process then, makes injection cefpiramide injectable powder.
Each particle diameter of forming of the present invention is: (a) aseptic cefpiramide, particle size range are 50 μ m(D
95) below, preferable range is 5～40 μ m; (b) sterile sodium carbonate, preferable particle size scope are 100～150 orders, present industrial particle size range, and need not further processing can use, and has reduced contamination of heavy; (c) particle size range is below the 90 μ m.The dissolubility of (c) used in the present invention material in water is big, can be dissolved in the transfusion rapidly, and (c) dissolved rapidly impel simultaneously (b) also dissolves (embodiment 1) rapidly, dissolves fast thereby make cefpiramide be converted into cefpiramide sodium.
Advantage of the present invention is to have solved the injection cefpiramide indissoluble that has gone on the market to separate, the insoluble problem of low temperature especially, and nurse operation is simple, and raw material is easy to get, and medicine stability is good.
Concrete embodiment
Embodiment 1 glucoses etc. are investigated with the composition dissolves speed of sodium carbonate
Adopt following two groups of samples under different temperatures, to use clinical common infusion fluid to carry out the investigation of dissolution velocity to pure sodium carbonate (sample 1) and sodium carbonate and mixture (c) (sample 2):
Sample 1: weighing sodium carbonate 50g presses the packing of 0.50g/ bottle.
Sample 2: weighing sodium carbonate 50g, (c) component an amount of (seeing Table 1), mix homogeneously contains sodium carbonate by 0.50g()/the bottle packing.
Dissolving method: manipulate clinical common infusion fluid 0.9% sodium chloride injection and 5% glucose injection 10ml routinely and dissolve, the results are shown in Table 1.
Pure sodium carbonate of table 1 and sodium carbonate and mixture (c) dissolution velocity under different temperatures relatively
As can be seen from Table 1, sodium carbonate is fast with the dissolution velocity of the purer sodium carbonate of dissolution velocity of (c) mixture, and promptly material such as glucose has the dissolving facilitation to sodium carbonate, and dissolution velocity is obviously fast during low temperature.
Embodiment 2
Weighing sodium carbonate 190g, Dextrose Monohydrate 500g adds cefpiramide 1000g behind the mix homogeneously, and remix is even, makes injection cefpiramide injectable powder by the packing of powder pin conventional production process then.
Embodiment 3
Weighing sodium carbonate 190g, sodium chloride 50g adds cefpiramide 1000g behind the mix homogeneously, and remix is even, makes injection cefpiramide injectable powder by the packing of powder pin conventional production process then.
Embodiment 4
Weighing sodium carbonate 190g, mannitol 500g adds cefpiramide 1000g behind the mix homogeneously, and remix is even, makes injection cefpiramide injectable powder by the packing of powder pin conventional production process then.
Embodiment 5
Weighing sodium carbonate 190g, sorbitol 500g adds cefpiramide 1000g behind the mix homogeneously, and remix is even, makes injection cefpiramide injectable powder by the packing of powder pin conventional production process then.
Embodiment 6
Weighing sodium carbonate 190g, anhydrous glucose 500g adds cefpiramide 1000g behind the mix homogeneously, and remix is even, makes injection cefpiramide injectable powder by the packing of powder pin conventional production process then.
Embodiment 7
Weighing sodium carbonate 190g, lactose monohydrate 500g adds cefpiramide 1000g behind the mix homogeneously, and remix is even, makes injection cefpiramide injectable powder by the packing of powder pin conventional production process then.
Embodiment 8
Weighing sodium carbonate 190g, Lactis Anhydrous 500g adds cefpiramide 1000g behind the mix homogeneously, and remix is even, makes injection cefpiramide injectable powder by the packing of powder pin conventional production process then.
Embodiment 9
Weighing sodium carbonate 184g, Dextrose Monohydrate 800g adds cefpiramide 800g behind the mix homogeneously, and remix is even, makes injection cefpiramide injectable powder by the packing of powder pin conventional production process then.
Embodiment 10
Weighing sodium carbonate 230g, sodium chloride 30g adds cefpiramide 1000g behind the mix homogeneously, and remix is even, makes injection cefpiramide injectable powder by the packing of powder pin conventional production process then.
Embodiment 11
Weighing sodium carbonate 720g, anhydrous glucose 180g adds cefpiramide 1800g behind the mix homogeneously, and remix is even, makes injection cefpiramide injectable powder by the packing of powder pin conventional production process then.
Embodiment 12
Weighing sodium carbonate 480g, lactose monohydrate 2400g adds cefpiramide 1200g behind the mix homogeneously, and remix is even, makes injection cefpiramide injectable powder by the packing of powder pin conventional production process then.
Embodiment 13
Weighing sodium carbonate 256g, Lactis Anhydrous 6400g adds cefpiramide 1600g behind the mix homogeneously, and remix is even, makes injection cefpiramide injectable powder by the packing of powder pin conventional production process then.
Embodiment 14
Weighing sodium carbonate 180g, sorbitol 120g adds cefpiramide 1200g behind the mix homogeneously, and remix is even, makes injection cefpiramide injectable powder by the packing of powder pin conventional production process then.
Embodiment 15
Weighing sodium carbonate 225g, mannitol 1500g adds cefpiramide 1500g behind the mix homogeneously, and remix is even, makes injection cefpiramide injectable powder by the packing of powder pin conventional production process then.
Embodiment 16
Weighing sodium carbonate 240g, anhydrous glucose 250g, mannitol 500g adds cefpiramide 1500g behind the mix homogeneously, and remix is even, makes injection cefpiramide injectable powder by the packing of powder pin conventional production process then.
Embodiment 17
Weighing sodium carbonate 230g, Lactis Anhydrous 350g, sorbitol 350g adds cefpiramide 1000g behind the mix homogeneously, and remix is even, makes injection cefpiramide injectable powder by the packing of powder pin conventional production process then.
Embodiment 18
Weighing sodium carbonate 720g, Dextrose Monohydrate 70g, sodium chloride 20g adds cefpiramide 1800g behind the mix homogeneously, and remix is even, makes injection cefpiramide injectable powder by the packing of powder pin conventional production process then.
Embodiment 19
Weighing sodium carbonate 240g, lactose monohydrate 480g, Dextrose Monohydrate 500g adds cefpiramide 1200g behind the sodium chloride 80g mix homogeneously, and remix is even, makes injection cefpiramide injectable powder by the packing of powder pin conventional production process then.
Embodiment 20
Weighing sodium carbonate 355g, mannitol 500g, glucose 350g adds cefpiramide 2000g behind the sorbitol 350g mix homogeneously, and remix is even, makes injection cefpiramide injectable powder by the packing of powder pin conventional production process then.
Embodiment 21 dissolving contrast tests
1. and 2. adopt the cefpiramide compositions of example 1～7 preparation and following reference composition (specification is 1.0g), under different temperatures, carry out the investigation of dissolution velocity.
Reference composition is 1.: the injection cefpiramide (1.0g) that has gone on the market
Reference composition is (by the preparation method preparation of Chinese patent 201010246519.x) 2.: take by weighing cefpiramide 1000g, and ultra-fine sodium carbonate 190g, mix homogeneously makes injection cefpiramide injectable powder by the packing of powder pin conventional production process then.
Dissolving method: routine operation uses clinical common infusion fluid 5% glucose injection and 0.9% sodium chloride injection 20ml to dissolve respectively, the results are shown in Table 2.
Table 2 routine operation uses the dissolution velocity of clinical common infusion fluid under different temperatures relatively
As can be seen from Table 2, the sample of using the technology of the present invention preparation uses different transfusions to dissolve under different temperatures, and all than reference composition 1. and 2. fast, advantage is more obvious under the cryogenic conditions for its dissolution velocity.
Embodiment 22 stability tests
Get the cefpiramide compositions of embodiment 1～7 preparation and the reference composition among the embodiment 24 1., specification is 1.0g, and in 40 ± 2 ℃, RH75 ± 5% time carries out stable accelerated test, investigates its stability.
The stable accelerated test contrast of table 3
As can be seen from Table 3, the stability of sample of application the technology of the present invention preparation is better.
Claims (2)
1. cefpiramide compositions is characterized in that the compositions that makes injection cefpiramide injectable powder by the packing of powder pin conventional production process is made up of following composition:
(a) aseptic cefpiramide;
(b) sterile sodium carbonate;
(c) aseptic anhydrous glucose, Dextrose Monohydrate, sodium chloride, mannitol, sorbitol, Lactis Anhydrous or lactose monohydrate and be wherein two kinds of compositions or the compositions of multiple composition;
The weight ratio of the above composition is (a): (b): (c)=and 1:0.15～0.4:0.03～4.0.
2. cefpiramide compositions according to claim 1, it is characterized in that in described (C) Dextrose Monohydrate, anhydrous glucose being arranged, each weight ratio of forming is (a) in the cefpiramide compositions of being formed: (b): Dextrose Monohydrate or anhydrous glucose=1:0.16～0.23:0.1～1.0.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2010105249722A CN101966152B (en) | 2010-10-29 | 2010-10-29 | Cefpiramide composite |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2010105249722A CN101966152B (en) | 2010-10-29 | 2010-10-29 | Cefpiramide composite |
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| CN101966152A true CN101966152A (en) | 2011-02-09 |
| CN101966152B CN101966152B (en) | 2012-05-09 |
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| CN2010105249722A Active CN101966152B (en) | 2010-10-29 | 2010-10-29 | Cefpiramide composite |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102772373A (en) * | 2011-05-11 | 2012-11-14 | 石药集团中奇制药技术（石家庄）有限公司 | Tartaric acid vinorelbine powder injection for injection and preparation method thereof |
| CN105232468A (en) * | 2015-11-03 | 2016-01-13 | 浙江永宁药业股份有限公司 | Flomoxef sodium powder injection and preparation method thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1965838A (en) * | 2005-11-17 | 2007-05-23 | 李海超 | Pharmaceutical composition containing cefpiramide and beta-lactamase inhibitor |
| CN101265267A (en) * | 2008-02-04 | 2008-09-17 | 山东罗欣药业股份有限公司 | Method for preparing cefozopran hydrochloride, cefozopran hydrochloride powder injection and preparation method thereof |
-
2010
- 2010-10-29 CN CN2010105249722A patent/CN101966152B/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1965838A (en) * | 2005-11-17 | 2007-05-23 | 李海超 | Pharmaceutical composition containing cefpiramide and beta-lactamase inhibitor |
| CN101265267A (en) * | 2008-02-04 | 2008-09-17 | 山东罗欣药业股份有限公司 | Method for preparing cefozopran hydrochloride, cefozopran hydrochloride powder injection and preparation method thereof |
Non-Patent Citations (1)
| Title |
|---|
| 《职业与健康》 20090531 孙立保 头孢菌素类抗生素与输液配伍的稳定性 1093-1094 1-2 第25卷, 第10期 2 * |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102772373A (en) * | 2011-05-11 | 2012-11-14 | 石药集团中奇制药技术（石家庄）有限公司 | Tartaric acid vinorelbine powder injection for injection and preparation method thereof |
| CN105232468A (en) * | 2015-11-03 | 2016-01-13 | 浙江永宁药业股份有限公司 | Flomoxef sodium powder injection and preparation method thereof |
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| Publication number | Publication date |
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| CN101966152B (en) | 2012-05-09 |
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