CN100336510C - Cefpiramide composition - Google Patents
Cefpiramide composition Download PDFInfo
- Publication number
- CN100336510C CN100336510C CNB2004100516859A CN200410051685A CN100336510C CN 100336510 C CN100336510 C CN 100336510C CN B2004100516859 A CNB2004100516859 A CN B2004100516859A CN 200410051685 A CN200410051685 A CN 200410051685A CN 100336510 C CN100336510 C CN 100336510C
- Authority
- CN
- China
- Prior art keywords
- cefpiramide
- cosolvent
- sodium carbonate
- acid
- weight ratio
- 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.)
- Expired - Lifetime
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- PWAUCHMQEXVFJR-PMAPCBKXSA-N cefpiramide Chemical compound C1=NC(C)=CC(O)=C1C(=O)N[C@H](C=1C=CC(O)=CC=1)C(=O)N[C@@H]1C(=O)N2C(C(O)=O)=C(CSC=3N(N=NN=3)C)CS[C@@H]21 PWAUCHMQEXVFJR-PMAPCBKXSA-N 0.000 title claims abstract description 44
- 229960005446 cefpiramide Drugs 0.000 title claims abstract description 25
- 239000000203 mixture Substances 0.000 title claims abstract description 18
- 239000006184 cosolvent Substances 0.000 claims abstract description 17
- CDBYLPFSWZWCQE-UHFFFAOYSA-L Sodium Carbonate Chemical compound [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 claims description 44
- 229910000029 sodium carbonate Inorganic materials 0.000 claims description 22
- 238000004090 dissolution Methods 0.000 description 9
- 238000002347 injection Methods 0.000 description 8
- 239000007924 injection Substances 0.000 description 8
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 6
- 239000003086 colorant Substances 0.000 description 4
- 239000000843 powder Substances 0.000 description 4
- 239000000243 solution Substances 0.000 description 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 4
- KLCDQSGLLRINHY-UHFFFAOYSA-N 1-phenyldiazenylnaphthalen-2-amine Chemical compound NC1=CC=C2C=CC=CC2=C1N=NC1=CC=CC=C1 KLCDQSGLLRINHY-UHFFFAOYSA-N 0.000 description 3
- 239000007864 aqueous solution Substances 0.000 description 3
- 239000003814 drug Substances 0.000 description 3
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 description 2
- 230000003115 biocidal effect Effects 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 238000001802 infusion Methods 0.000 description 2
- 238000010255 intramuscular injection Methods 0.000 description 2
- 239000007927 intramuscular injection Substances 0.000 description 2
- 238000010253 intravenous injection Methods 0.000 description 2
- 239000002932 luster Substances 0.000 description 2
- 229910000162 sodium phosphate Inorganic materials 0.000 description 2
- 239000001488 sodium phosphate Substances 0.000 description 2
- 235000011008 sodium phosphates Nutrition 0.000 description 2
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 description 2
- 241000894006 Bacteria Species 0.000 description 1
- 241000192125 Firmicutes Species 0.000 description 1
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 1
- NNJVILVZKWQKPM-UHFFFAOYSA-N Lidocaine Chemical compound CCN(CC)CC(=O)NC1=C(C)C=CC=C1C NNJVILVZKWQKPM-UHFFFAOYSA-N 0.000 description 1
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 1
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 1
- 229910052782 aluminium Inorganic materials 0.000 description 1
- 239000004411 aluminium Substances 0.000 description 1
- 239000006067 antibiotic powder Substances 0.000 description 1
- 244000052616 bacterial pathogen Species 0.000 description 1
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 description 1
- 230000037396 body weight Effects 0.000 description 1
- 210000001217 buttock Anatomy 0.000 description 1
- 229920005549 butyl rubber Polymers 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 238000013329 compounding Methods 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 238000005138 cryopreservation Methods 0.000 description 1
- BNIILDVGGAEEIG-UHFFFAOYSA-L disodium hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])([O-])=O BNIILDVGGAEEIG-UHFFFAOYSA-L 0.000 description 1
- 229910000397 disodium phosphate Inorganic materials 0.000 description 1
- 235000019800 disodium phosphate Nutrition 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 235000021050 feed intake Nutrition 0.000 description 1
- 239000011521 glass Substances 0.000 description 1
- 239000008103 glucose Substances 0.000 description 1
- 229960004194 lidocaine Drugs 0.000 description 1
- 238000012856 packing Methods 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 238000007789 sealing Methods 0.000 description 1
- 238000004904 shortening Methods 0.000 description 1
- 229910000030 sodium bicarbonate Inorganic materials 0.000 description 1
- 235000017557 sodium bicarbonate Nutrition 0.000 description 1
- 230000001954 sterilising effect Effects 0.000 description 1
- 238000004659 sterilization and disinfection Methods 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 239000003643 water by type Substances 0.000 description 1
- 239000008215 water for injection Substances 0.000 description 1
Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
The present invention relates to a cefpiramide composition and discloses that the composition is prepared by mixing sterile cefpiramide acid and a sterile cosolvent, wherein the weight ratio of the cefpiramide acid to the cosolvent is from 1:0.10 to 1:0.6. The present invention has the advantage of stable quality when preserved at a normal temperature and is quickly dissolved when clinically used.
Description
Technical field
The present invention relates to human antibiotic powder pin, the injection cefpiramide injectable powder of clinical use specifically.
Background technology
At present, as the antibiotic Cefpiramide sodium powder injection agent of using clinically of human, extensively using, cefpiramide has the obvious treatment effect on pathogenic bacterium such as treatment gram positive bacteria and gram negative bacteria, cefpiramide sodium good water solubility, weak point are the less stable of cefpiramide sodium, need cryopreservation, and in the storage life, related substance significantly increases, and content significantly descends.
Summary of the invention
The purpose of this invention is to provide a kind of cefpiramide compositions, its room temperature is preserved steady quality, and clinical use dissolving rapidly.
Technical solution of the present invention is that aseptic Cefpiramide Acid and sterile sodium carbonate cosolvent mix, and Cefpiramide Acid and cosolvent weight ratio are 1: 0.1 to 1: 0.6.
More than Cefpiramide Acid of the present invention and cosolvent sodium carbonate preferably weight ratio be 1: 0.13～1: 0.5.
The better weight ratio scope of Cefpiramide Acid of the present invention and cosolvent sodium carbonate is 1: 0.16～1: 0.22.
The optimum weight ratio of Cefpiramide Acid of the present invention and cosolvent sodium carbonate is 1: 0.19.
PH scope after the above present composition dissolving is 7.5～10.0.
The pH scope of said composition dissolving of the present invention back the best is 8.0～9.0.
Preparating mechanism of the present invention is a cefpiramide acid-utilising sodium carbonate hydrotropy, and Cefpiramide Acid itself is water insoluble, utilizes Cefpiramide Acid and sodium carbonate can react rapidly in water, generates water-soluble cefpiramide sodium.
In the cosolvent of the present invention, Cefpiramide Acid and arginic weight ratio scope are 1: 0.3 to 1: 0.6, with sodium bicarbonate weight ratio scope be 1: 0.3 to 1: 0.6, with the weight ratio scope of sodium hydroxide be 1: 0.1 to 1: 0.2, with sodium hydrogen phosphate weight ratio scope be 1: 0.3 to 1: 0.6, with the weight ratio scope of sodium phosphate be 1: 0.2 to 1: 0.4.
Injectable powder stability of the present invention is high, can preserve at normal temperatures.
The relation of the addition of the sodium carbonate of cefpiramide compositions of the present invention, pH value, dissolution velocity:
1) addition of pH value and sodium carbonate is proportionate, and the amount that sodium carbonate adds is many more, and pH value is high more.
2) addition of dissolution time and pH value, sodium carbonate is negative correlation, and pH value is high more, and the dissolving required time is just short more, helps shortening the time of clinical pharmacy more.
3) appearance luster and pH value, sodium carbonate addition are proportionate, and the amount that adds sodium carbonate is many more, and pH value is high more, and solution colour is dark more, and this explanation pH value is high more, and sample is just unstable more in aqueous solution.
Clinical practice, need to select dissolution time short, stability is sample preferably, from following table as can be seen the best ratio range of sodium carbonate and Cefpiramide Acid be: 1: 0.16～1: 0.22, in this scope, pH is 8.0～9.0, between dissolution time 30S～60S, the aqueous solution color less than or be equivalent to yellow 1 color.Wherein best proportioning point is 1: 0.19, and on this aspect, pH value is 8.66, and dissolution time is 35S, and the aqueous solution color is less than yellow No. 1 color.
Cefpiramide compositions of the present invention is in Cefpiramide Acid: the ratio of sodium carbonate is to feed intake at 1: 0.19, with existing " cefpiramide sodium for injection " through 40 ℃ of tests that keep sample, prove that its stability improves greatly.
The packing of injection cefpiramide:
After aseptic Cefpiramide Acid and the mixing of aseptic cosolvent, contain 1 gram cefpiramide branch by every bottle and be filled in the control antibiotic glass bottle of sterilization, add a cover butyl rubber plug, the compound aluminium lid of reuse is tightened sealing.
The usage and dosage of injection cefpiramide:
But this product intramuscular injection or intravenous injection or slow infusion at 30～60 minutes.
Intravenously administrable:
The common daily dosage of being grown up is that per 12 hours 1 grams are to 2 grams.
Child's daily dose is 20 milligrams to 80 milligrams of pers kilogram of body weight, divides two to three administrations.
Adult's daily dose rises to 4 grams, is divided into two to three administrations according to patient's situation.
This product is a sterile injection powder, can use: water for injection (1 gram is dissolved in 10 milliliters of waters for injection), glucose or normal saline.Isosmotic solution only uses when infusion.
Intramuscular injection:
Dosage is same as intravenous injection.1 gram cefpiramide is dissolved in 6 milliliters 1% the lignocaine solution.Be injected in outer last 1/4th places of buttocks: about each half.
Advantage of the present invention is that its room temperature is preserved steady quality, and clinical use dissolving rapidly.
The specific embodiment
The best proportioning of sodium carbonate of the present invention and the optimal pH of hydrotropy
| Cefpiramide Acid: sodium carbonate (mass ratio) | PH value | Appearance luster | Dissolution time (second) |
| 1∶0.13 | 7.41 | Be not deeper than yellow No. 1 color | ＞120s |
| 1∶0.14 | 7.56 | Be not deeper than yellow No. 1 color | 104s |
| 1∶0.15 | 7.91 | Be not deeper than yellow No. 1 color | 90s |
| 1∶0.16 | 8.00 | Be not deeper than yellow No. 1 color | 47s |
| 1∶0.17 | 8.36 | Be not deeper than yellow No. 1 color | 46s |
| 1∶0.18 | 8.60 | Be not deeper than yellow No. 1 color | 40s |
| 1∶0.19 | 8.66 | Be not deeper than yellow No. 1 color | 35s |
| 1∶0.2 | 8.82 | Be equivalent to yellow No. 1 color | 37s |
| 1∶0.21 | 8.82 | Be equivalent to yellow No. 1 color | 33s |
| 1∶0.22 | 9.00 | Be equivalent to yellow No. 1 color | ＜30s |
| 1∶0.3 | 9.30 | Be equivalent to yellow No. 2 colors | ＜30s |
| 1∶0.33 | 9.39 | Be equivalent to yellow No. 2 colors | ＜30s |
| 1∶0.36 | 9.50 | Be equivalent to yellow No. 2 colors | ＜30s |
| 1∶O.5 | 9.61 | Be equivalent to yellow No. 2 colors | ＜30s |
Cosolvent and best cosolvent
As seen from the above table: what dissolution time was the shortest is sodium carbonate, sodium phosphate, sodium hydroxide.Medicine dissolution is fast more clinically, can shorten time of compounding more, is convenient to clinical practice.Therefore, analyze from the dissolution velocity of product, the stability and the drug safety each side of medicine: sodium carbonate is the best cosolvent of preparation injection cefpiramide.
Claims (6)
1, cefpiramide compositions is characterized in that it is mixed by aseptic Cefpiramide Acid and sterile sodium carbonate cosolvent, and Cefpiramide Acid and cosolvent weight ratio are 1: 0.10 to 1: 0.6.
2, cefpiramide compositions according to claim 1, the weight ratio that it is characterized in that Cefpiramide Acid and cosolvent sodium carbonate is 1: 0.13～1: 0.5.
3, cefpiramide compositions according to claim 2, the weight ratio scope that it is characterized in that Cefpiramide Acid and cosolvent sodium carbonate is 1: 0.16～1: 0.22.
4, cefpiramide compositions according to claim 3 is characterized in that the weight ratio of Cefpiramide Acid and cosolvent sodium carbonate is 1: 0.19.
5, cefpiramide compositions according to claim 1 is characterized in that pH scope after the said composition dissolving is 7.5～10.0.
6, cefpiramide compositions according to claim 5 is characterized in that pH scope after the said composition dissolving is 8.0～9.0.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2004100516859A CN100336510C (en) | 2004-09-30 | 2004-09-30 | Cefpiramide composition |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2004100516859A CN100336510C (en) | 2004-09-30 | 2004-09-30 | Cefpiramide composition |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1634074A CN1634074A (en) | 2005-07-06 |
| CN100336510C true CN100336510C (en) | 2007-09-12 |
Family
ID=34846082
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB2004100516859A Expired - Lifetime CN100336510C (en) | 2004-09-30 | 2004-09-30 | Cefpiramide composition |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN100336510C (en) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101284009B (en) * | 2008-05-29 | 2011-03-09 | 管小明 | Cefoperazone sodium and sulbactam sodium combination and preparation method thereof |
| CN102286002B (en) * | 2011-08-31 | 2013-07-03 | 山东罗欣药业股份有限公司 | Cefpiramide sodium powder injection composition and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR950010155B1 (en) * | 1992-10-10 | 1995-09-11 | 주식회사종근당 | Sefpyramide preparation for rapid soluble injection |
-
2004
- 2004-09-30 CN CNB2004100516859A patent/CN100336510C/en not_active Expired - Lifetime
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR950010155B1 (en) * | 1992-10-10 | 1995-09-11 | 주식회사종근당 | Sefpyramide preparation for rapid soluble injection |
Non-Patent Citations (3)
| Title |
|---|
| 先福吡兰 袁华，中国新药杂志，第7卷第2期 1998 * |
| 头孢匹胺临床药物动力学研究 施耀国等，中国抗生素杂志，第25卷第4期 2000 * |
| 头孢匹胺治疗急性细菌性感染临床评价 张慧琳等，中国抗生素杂志，第28卷第11期 2003 * |
Also Published As
| Publication number | Publication date |
|---|---|
| CN1634074A (en) | 2005-07-06 |
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| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| CX01 | Expiry of patent term |
Granted publication date: 20070912 |