CN102106830B - Cefmetazole sodium liposome freeze-dried preparation and preparation method - Google Patents
Cefmetazole sodium liposome freeze-dried preparation and preparation method Download PDFInfo
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- CN102106830B CN102106830B CN2011100262585A CN201110026258A CN102106830B CN 102106830 B CN102106830 B CN 102106830B CN 2011100262585 A CN2011100262585 A CN 2011100262585A CN 201110026258 A CN201110026258 A CN 201110026258A CN 102106830 B CN102106830 B CN 102106830B
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- preparation
- dried preparation
- cefmetazon
- sankyo
- cefmetazole sodium
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Abstract
The invention provides a cefmetazole sodium liposome freeze-dried preparation and a preparation method. The method comprises the following steps of: adding cefmetazole sodium, a stabilizing agent and an excipient into a blank membrane material made of a liposome carrier, performing ultrasonic processing, fixing volume, filling, and freeze drying to obtain the cefmetazole sodium liposome freeze-dried preparation. The cefmetazole sodium liposome freeze-dried preparation prepared by the method overcomes the defect of formulations appear on the market, has improved stability and is safer in clinical application of medicaments.
Description
Technical field:
The present invention relates to a kind of being used to treats the cephalosporins medicine by infecting due to staphylococcus aureus, escherichia coli, pneumobacillus, Proteus, morganella morganii, Providencia, Peptostreptococcus, the Bacteroides, particularly relates to a kind of cefmetazole sodium lipidosome freeze-dried preparation and method for preparing.
Background technology:
Cefmetazon (Sankyo), chemical name is: (6R, 7R)-7-[2-[(cyanogen methyl) sulfur] acetylamino]-7-methoxyl group-3-[(1-methyl isophthalic acid H-tetrazolium-5-yl) sulfane ylmethyl]-8-oxo-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylic acid sodium salt.
Chemical structural formula:
Molecular formula: C
15H
16N
7NaO
5S
3Molecular weight: 493.52
Cefmetazon (Sankyo) is that second filial generation cephalo is plain, is a kind of semi-synthetic antimicrobial drug of non-gastrointestinal applications, is at first introduced clinically by Japan, and the U.S. and other country have also carried out a large amount of animals and clinical research.Numerous relevant its safely and effectively data prove that all this medicine is to many G
-And G
+Aerobic and anaerobism all has antibacterial activity, and clinical efficacy is high, and toxic and side effects is low, and anaphylaxis is few, can be widely used in the control of clinical various infectious disease.Be at present aseptic subpackaged in the dosage form of listing, dissolve again during clinical use.Because these article are easy to generate deposition to temperature, illumination, humidity instability during use, in production and transport, use, very easily cause mass change, have increased the insecurity of clinical application.
Compare down because liposome has characteristics such as stability is high, envelop rate is good, through with drug encapsulation in membrane material, reduce contacting of medicine and environment, thereby can solve the caused clinical hidden danger of Cefmetazon (Sankyo) quality instability.Still supplementary invention a kind of ceftezole sodium lipidosome freeze-dried preparation, to remedy the weak point of Cefmetazon (Sankyo) listing dosage form.
Summary of the invention
The objective of the invention is to replenish with the Cefmetazon (Sankyo) is the deficiency of the pharmaceutical preparation of active component; A kind of cefmetazole sodium lipidosome freeze-dried preparation prescription and method for preparing are provided; Not enough to reduce the existing pharmaceutical dosage form of these article, improve medicine stability, strengthened the safety that clinical drug is used.
A kind of cefmetazole sodium lipidosome freeze-dried preparation provided by the invention and method for preparing, its prescription consists of:
1.0 unit of weights of Cefmetazon (Sankyo)
1.0～1.5 unit of weights of stabilizing agent
1.0～5.0 unit of weights of liposome vectors
1.0 unit of weights of excipient
0.5～3.0 unit of weight 0 of buffer salt.
In the prescription that the present invention proposes, the concentration of Cefmetazon (Sankyo) is 1.0 unit of weights.
In the prescription that the present invention proposes, the liposome vectors of being selected for use is one or more of Ovum Gallus domesticus Flavus lecithin, two stearic acid lecithin, soybean lecithin, two palmitic acid lecithin.
In the prescription that the present invention proposes, the excipient of being selected for use is a mannitol.
In the prescription that the present invention proposes, the buffer salt of being selected for use is 10% hydrophosphate.
In the prescription that the present invention proposes, the stabilizing agent of being selected for use is a sodium chloride.
The method for preparing that this prescription proposes, making cefmetazole sodium lipidosome particle diameter is 50～150nm.
The present invention proposes the method for preparing of cefmetazole sodium lipidosome freeze-dried preparation, may further comprise the steps: 1. and take by weighing recipe quantity Cefmetazon (Sankyo), stabilizing agent, excipient, mix water-solublely, stir, for use; 2. take by weighing an amount of buffer salt and be mixed with the finite concentration buffer salt solution; In the liposome vectors of recipe quantity disperseed to be dissolved in, drying under reduced pressure formed membrane material; Add in the above-mentioned aqueous solution Cefmetazon (Sankyo) liposome turbid liquor of supersound process to the required particle diameter and the uniformity; Standardize solution, vacuum lyophilization is carried out in fill, promptly gets the cefmetazole sodium lipidosome freeze-dried preparation.
Technical characterstic of the present invention is through the cefmetazole sodium lipidosome freeze-dried preparation that this prescription and method for preparing make good stable property to be arranged,
The specific embodiment
With by way of example the present invention is described further again below, provides implementation detail of the present invention, but be not to be intended to limit protection scope of the present invention.
Embodiment 1:
1.0 unit of weights of Cefmetazon (Sankyo)
1.5 unit of weights of sodium chloride
Ovum Gallus domesticus Flavus lecithin, two stearic acid lecithin, soybean lecithin mix at 1: 1 gets 2.5 unit of weights
1.0 unit of weights of mannitol
0.5～3.0 unit of weight of dibastic sodium phosphate
Take by weighing recipe quantity Cefmetazon (Sankyo), sodium chloride, mannitol and mix water-solublely, stir, for use; Take by weighing an amount of dibastic sodium phosphate and be mixed with 10% buffer salt solution; In the Ovum Gallus domesticus Flavus lecithin of recipe quantity, two stearic acid lecithin, soybean lecithin disperseed to be dissolved in; Drying under reduced pressure; Form the blank film material, add in the above-mentioned aqueous solution, the Cefmetazon (Sankyo) liposome turbid liquor of supersound process to the required particle diameter and the uniformity; Standardize solution, vacuum lyophilization is carried out in fill, promptly gets the cefmetazole sodium lipidosome freeze-dried preparation.
Embodiment 2
1.0 unit of weights of Cefmetazon (Sankyo)
1.5 unit of weights of sodium chloride
5.0 unit of weights of two palmitic acid lecithin
1.0 unit of weights of mannitol
0.5～3.0 unit of weight of calcium hydrogen phosphate
Take by weighing recipe quantity Cefmetazon (Sankyo), sodium chloride, mannitol and mix water-solublely, stir, for use; Take by weighing an amount of calcium hydrogen phosphate and be mixed with 10% buffer salt solution; In the two palmitic acid lecithin of recipe quantity were disperseed to be dissolved in, drying under reduced pressure formed the blank film material; Add in the above-mentioned aqueous solution Cefmetazon (Sankyo) liposome turbid liquor of supersound process to the required particle diameter and the uniformity; Standardize solution, vacuum lyophilization is carried out in fill, promptly gets the cefmetazole sodium lipidosome freeze-dried preparation.
Claims (2)
1. cefmetazole sodium lipidosome freeze-dried preparation; It is characterized in that said preparation processed by following materials of weight proportions: Cefmetazon (Sankyo): sodium chloride: liposome vectors: mannitol: dibastic sodium phosphate=1.0: 1.5: 5.0: 1.0: 0.5～3.0, wherein liposome vectors is two palmitic acid lecithin.
2. the method for preparing of the described cefmetazole sodium lipidosome freeze-dried preparation of claim 1 is characterized in that, may further comprise the steps:
(1) take by weighing recipe quantity Cefmetazon (Sankyo), sodium chloride, mannitol, mix soluble in waterly, stir, for use;
(2) take by weighing dibastic sodium phosphate and be mixed with buffer salt solution, in the liposome vectors of recipe quantity was disperseed to be dissolved in, drying under reduced pressure formed membrane material, adds in the above-mentioned aqueous solution, and supersound process obtains the Cefmetazon (Sankyo) liposome turbid liquor; Standardize solution, vacuum lyophilization is carried out in fill, promptly gets the cefmetazole sodium lipidosome freeze-dried preparation.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2011100262585A CN102106830B (en) | 2011-01-25 | 2011-01-25 | Cefmetazole sodium liposome freeze-dried preparation and preparation method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2011100262585A CN102106830B (en) | 2011-01-25 | 2011-01-25 | Cefmetazole sodium liposome freeze-dried preparation and preparation method |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN102106830A CN102106830A (en) | 2011-06-29 |
| CN102106830B true CN102106830B (en) | 2012-07-04 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2011100262585A Expired - Fee Related CN102106830B (en) | 2011-01-25 | 2011-01-25 | Cefmetazole sodium liposome freeze-dried preparation and preparation method |
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Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103044459B (en) * | 2012-12-28 | 2014-10-22 | 吴秋萍 | Novel cefmetazole compound and medicine composition thereof |
| CN109718213B (en) * | 2019-01-24 | 2021-06-08 | 四川制药制剂有限公司 | Preparation method of cefmetazole sodium for injection |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101623264A (en) * | 2009-08-24 | 2010-01-13 | 海南美大制药有限公司 | Cefmetazole sodium proliposome preparation |
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2011
- 2011-01-25 CN CN2011100262585A patent/CN102106830B/en not_active Expired - Fee Related
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101623264A (en) * | 2009-08-24 | 2010-01-13 | 海南美大制药有限公司 | Cefmetazole sodium proliposome preparation |
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| CN102106830A (en) | 2011-06-29 |
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Granted publication date: 20120704 Termination date: 20130125 |