CN105078902A - Cefetamet pivoxil hydrochloride composite granules for treating bacterial infection - Google Patents
Cefetamet pivoxil hydrochloride composite granules for treating bacterial infection Download PDFInfo
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- CN105078902A CN105078902A CN201510614416.7A CN201510614416A CN105078902A CN 105078902 A CN105078902 A CN 105078902A CN 201510614416 A CN201510614416 A CN 201510614416A CN 105078902 A CN105078902 A CN 105078902A
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- pivoxil hydrochloride
- cefetamet pivoxil
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Abstract
The invention discloses cefetamet pivoxil hydrochloride composite granules for treating bacterial infection, and belongs to the technical field of medicines. A composite is prepared from cefetamet pivoxil hydrochloride, mannitol, carboxymethylcellulose, glycine, absolute ethyl alcohol, polysorbate 80 and banana essence. The cefetamet pivoxil hydrochloride is a novel compound, an X-ray powder diffraction pattern obtained by using Cu-Kalpha rays for measurement is shown as the figure 1, and the cefetamet pivoxil hydrochloride is different from cefetamet pivoxil hydrochloride in the prior art. It is found through tests that the granules prepared from the new crystal-form cefetamet pivoxil hydrochloride composite is low in high-molecular polymer content and high in stability, and the high-molecular polymer content is increased little along with the passage of time; the composite has more remarkable antibacterial activity to pneumococcocci and bacillus influenzae and high antibacterial activity to enterococcocci and staphylococcocci.
Description
Technical field
The invention belongs to medical art, relate to a kind of medicine Cefetamet Pivoxil Hydrochloride composition granule for the treatment of bacteriological infection.
Background technology
Cefetamet Pivoxil Hydrochloride is third generation broad-spectrum cephalosporin class antibiotic.The cefetamet being hydrolyzed to rapidly antibacterial activity after oral in vivo plays bactericidal action.Cefetamet Pivoxil Hydrochloride is to gram positive bacterias such as Streptococcus (except streptococcus faecalis), streptococcus pneumoniae, and have very strong antibacterial activity to escherichia coli, Klebsiella, hemophilus influenza, Diplococcus gonorrhoeae, especially obvious to the antibacterial activity of the low Serratia of cephalosporin sensitivity, indole-positive Bacillus proteus, Enterobacter and citric acid Pseudomonas.Bacteriogenic beta-lactamase is stablized.Cefetamet Pivoxil Hydrochloride is invalid to Pseudomonas, mycoplasma, chlamydia, enterococcus and drug resistance staphylococcus.
But because its basic structure is the same with antibiotic in the many semisynthetic beta-lactam gone on the market, Cefetamet Pivoxil Hydrochloride also can form high molecular polymer, also can cause type Ⅰ hypersensitivity reaction in Clinical practice, very harmful to patient.Prior art improves its stability from aspects such as raising content, reduction impurity mostly.
Research proves, the anaphylactogen causing beta-lactam antibiotic type Ⅰ hypersensitivity reaction is relevant with the high molecular polymer content wherein existed.Reduce the high molecular polymer content existed in Cefetamet Pivoxil Hydrochloride crude drug, improve stability, make it can ensure the lower effective way being the reaction of reduction anaphylactic shock and occurring of the content of its high molecular polymer existed in long term storage.Therefore, be necessary to provide the cefetamet pivoxil hydrochloride compound that a kind of high molecular polymer content is low, performance is more superior.
Summary of the invention
Goal of the invention of the present invention is to provide a kind of medicine Cefetamet Pivoxil Hydrochloride composition granule for the treatment of bacteriological infection.
In order to complete object of the present invention, the technical scheme of employing is:
Treat a medicine Cefetamet Pivoxil Hydrochloride composition granule for bacteriological infection, described composition granule is made up of Cefetamet Pivoxil Hydrochloride, mannitol, carboxymethyl cellulose, glycine, dehydrated alcohol, polyoxyethylene sorbitan monoleate, flavoring banana essence; Described Cefetamet Pivoxil Hydrochloride is crystal, and the X-ray powder diffraction pattern that the measurement of use Cu-K alpha ray obtains as shown in Figure 1.
Preferably, described composition granule is made up of the Cefetamet Pivoxil Hydrochloride of 1.25 weight portions, the mannitol of 0.8-1.2 weight portion, the carboxymethyl cellulose of 0.6-0.8 weight portion, the glycine of 0.3-0.5 weight portion, the dehydrated alcohol of 0.5-0.7 weight portion, the polyoxyethylene sorbitan monoleate of 0.04-0.06 weight portion, the flavoring banana essence of 0.04-0.06 weight portion.
Preferably, described composition granule is made up of the Cefetamet Pivoxil Hydrochloride of 1.25 weight portions, the mannitol of 1.0 weight portions, the carboxymethyl cellulose of 0.7 weight portion, the glycine of 0.4 weight portion, the dehydrated alcohol of 0.6 weight portion, the polyoxyethylene sorbitan monoleate of 0.05 weight portion, the flavoring banana essence of 0.05 weight portion.
The preparation method of described composition granule comprises the following steps:
(1) supplementary material process: sieve Cefetamet Pivoxil Hydrochloride, mannitol, carboxymethyl cellulose, glycine 80 orders;
(2) weigh: weigh according to prescription;
(3) binding agent preparation: the polyoxyethylene sorbitan monoleate of recipe quantity is dissolved in dehydrated alcohol, stand-by;
(4) granulate: the Cefetamet Pivoxil Hydrochloride taken, mannitol, carboxymethyl cellulose, glycine are poured in efficient wet mixer-granulator, stirring frequency 20Hz is set, unlatching is uniformly mixed 90-150s, after mixing, add polyoxyethylene sorbitan monoleate alcoholic solution, chopping frequency 40Hz is set, opens chopping and granulate, discharging;
(5) dry: the wet granular of granulation gained is evenly split in dry car drip pan on, set temperature 55-65 DEG C, dry total time is 2-3 hour, and after dry, material sieves 40-18 order;
(6) mix: after sieving, granule and flavoring banana essence drop into three-dimensional motion mixer, arrange premixing speed 15 revs/min, incorporation time 10 minutes;
(7) pack: use particles packing machine subpackage.
The preparation method of the crystal of described Cefetamet Pivoxil Hydrochloride comprises the following steps:
Volume Cefetamet Pivoxil Hydrochloride being dissolved in 35 DEG C is in the ethanol of 10 times of Cefetamet Pivoxil Hydrochloride weight and the mixed solvent of acetone, the volume ratio of ethanol and acetone is 3:1, after dissolving completes, add the iso-butanol solvent that volume is 6 times of Cefetamet Pivoxil Hydrochloride weight, room temperature is reduced the temperature in 1-2 hour, 1 hour is kept in room temperature, then, cool to-5 DEG C to-10 DEG C further again, then, place 3 hours at-5 DEG C to-10 DEG C, crystallize out, namely obtains Cefetamet Pivoxil Hydrochloride crystal.
The polymorphism of solid chemical is the natural phenomena that a kind of general material exists, this phenomenon refers to that a kind of solid chemical can exist 2 kinds or two or more crystal form state, be also called the polymorphic state of material, the polymorphic state of material is also referred to as " allomorphism " phenomenon.Although its chemical nature of allomorphous solid matter is identical, its physicochemical property may be different.For " allomorphism medicine " that physicochemical property is different, also can show the curative effect of different disease preventing and treating clinically, directly affect application and the clinical effectiveness of medicine.
Because the basic structure of Cefetamet Pivoxil Hydrochloride is the same with antibiotic in the many semisynthetic beta-lactam gone on the market, also type Ⅰ hypersensitivity reaction can be caused in Clinical practice, very harmful to patient.Research proves, the anaphylactogen causing beta-lactam antibiotic type Ⅰ hypersensitivity reaction is relevant with the high molecular polymer content wherein existed.But prior art improves its stability from aspects such as raising content, reduction impurity mostly, does not propose any improvement to high molecular polymer content wherein.
Compared with prior art, tool of the present invention has the following advantages:
(1) cefetamet pivoxil hydrochloride compound provided by the present invention is crystal compound, it is a kind of cefetamet pivoxil hydrochloride compound being different from prior art report, find through test, this Cefetamet Pivoxil Hydrochloride crystal compound is compared compared with the cefetamet pivoxil hydrochloride compound of prior art, not only there is lower high molecular polymer content, and increase seldom along with its high molecular polymer content of prolongation of period of storage, obtained granule has good stability, the advantages such as impurity content is low;
(2) cefetamet pivoxil hydrochloride compound of the present invention has more significant antibacterial activity to streptococcus pneumoniae, hemophilus influenza, and also has stronger antibacterial activity to the Cefetamet Pivoxil Hydrochloride of prior art report without the enterococcus of antibacterial activity, staphylococcus.
Accompanying drawing explanation
Fig. 1 is the X-ray powder diffraction that the Cefetamet Pivoxil Hydrochloride crystal of the embodiment of the present invention 1 preparation uses the measurement of Cu-K alpha ray to obtain.
Detailed description of the invention
Below by specific embodiment, summary of the invention of the present invention is described in further detail, but does not therefore limit content of the present invention.
embodiment 1:the preparation of Cefetamet Pivoxil Hydrochloride crystal
Volume Cefetamet Pivoxil Hydrochloride being dissolved in 35 DEG C is in the ethanol of 10 times of Cefetamet Pivoxil Hydrochloride weight and the mixed solvent of acetone, the volume ratio of ethanol and acetone is 3:1, after dissolving completes, add the iso-butanol solvent that volume is 6 times of Cefetamet Pivoxil Hydrochloride weight, room temperature is reduced the temperature in 1-2 hour, 1 hour is kept in room temperature, then, cool to-5 DEG C to-10 DEG C further again, then, place 3 hours at-5 DEG C to-10 DEG C, crystallize out, namely obtains Cefetamet Pivoxil Hydrochloride crystal.
The X-ray powder diffraction pattern that the Cefetamet Pivoxil Hydrochloride crystal prepared uses the measurement of Cu-K alpha ray to obtain as shown in Figure 1.
embodiment 2:the preparation of Cefetamet Pivoxil Hydrochloride granule
Prescription: Cefetamet Pivoxil Hydrochloride crystal-form compound, the mannitol of 0.8 weight portion, the carboxymethyl cellulose of 0.6 weight portion, the glycine of 0.3 weight portion, the dehydrated alcohol of 0.5 weight portion, the polyoxyethylene sorbitan monoleate of 0.04 weight portion, the flavoring banana essence of 0.04 weight portion that the embodiment 1 of 1.25 weight portions is obtained.
Preparation method:
(1) supplementary material process: sieve Cefetamet Pivoxil Hydrochloride, mannitol, carboxymethyl cellulose, glycine 80 orders;
(2) weigh: weigh according to prescription;
(3) binding agent preparation: the polyoxyethylene sorbitan monoleate of recipe quantity is dissolved in dehydrated alcohol, stand-by;
(4) granulate: the Cefetamet Pivoxil Hydrochloride taken, mannitol, carboxymethyl cellulose, glycine are poured in efficient wet mixer-granulator, stirring frequency 20Hz is set, unlatching is uniformly mixed 90-150s, after mixing, add polyoxyethylene sorbitan monoleate alcoholic solution, chopping frequency 40Hz is set, opens chopping and granulate, discharging;
(5) dry: the wet granular of granulation gained is evenly split in dry car drip pan on, set temperature 55-65 DEG C, dry total time is 2-3 hour, and after dry, material sieves 40-18 order;
(6) mix: after sieving, granule and flavoring banana essence drop into three-dimensional motion mixer, arrange premixing speed 15 revs/min, incorporation time 10 minutes;
(7) pack: use particles packing machine subpackage.
embodiment 3:the preparation of Cefetamet Pivoxil Hydrochloride granule
Prescription: Cefetamet Pivoxil Hydrochloride crystal-form compound, the mannitol of 1.0 weight portions, the carboxymethyl cellulose of 0.7 weight portion, the glycine of 0.4 weight portion, the dehydrated alcohol of 0.6 weight portion, the polyoxyethylene sorbitan monoleate of 0.05 weight portion, the flavoring banana essence of 0.05 weight portion that the embodiment 1 of 1.25 weight portions is obtained.
Preparation method:
(1) supplementary material process: sieve Cefetamet Pivoxil Hydrochloride, mannitol, carboxymethyl cellulose, glycine 80 orders;
(2) weigh: weigh according to prescription;
(3) binding agent preparation: the polyoxyethylene sorbitan monoleate of recipe quantity is dissolved in dehydrated alcohol, stand-by;
(4) granulate: the Cefetamet Pivoxil Hydrochloride taken, mannitol, carboxymethyl cellulose, glycine are poured in efficient wet mixer-granulator, stirring frequency 20Hz is set, unlatching is uniformly mixed 90-150s, after mixing, add polyoxyethylene sorbitan monoleate alcoholic solution, chopping frequency 40Hz is set, opens chopping and granulate, discharging;
(5) dry: the wet granular of granulation gained is evenly split in dry car drip pan on, set temperature 55-65 DEG C, dry total time is 2-3 hour, and after dry, material sieves 40-18 order;
(6) mix: after sieving, granule and flavoring banana essence drop into three-dimensional motion mixer, arrange premixing speed 15 revs/min, incorporation time 10 minutes;
(7) pack: use particles packing machine subpackage.
embodiment 4:the preparation of Cefetamet Pivoxil Hydrochloride granule
Prescription: Cefetamet Pivoxil Hydrochloride crystal-form compound, the mannitol of 1.2 weight portions, the carboxymethyl cellulose of 0.8 weight portion, the glycine of 0.5 weight portion, the dehydrated alcohol of 0.7 weight portion, the polyoxyethylene sorbitan monoleate of 0.06 weight portion, the flavoring banana essence of 0.06 weight portion that the embodiment 1 of 1.25 weight portions is obtained.
Preparation method:
(1) supplementary material process: sieve Cefetamet Pivoxil Hydrochloride, mannitol, carboxymethyl cellulose, glycine 80 orders;
(2) weigh: weigh according to prescription;
(3) binding agent preparation: the polyoxyethylene sorbitan monoleate of recipe quantity is dissolved in dehydrated alcohol, stand-by;
(4) granulate: the Cefetamet Pivoxil Hydrochloride taken, mannitol, carboxymethyl cellulose, glycine are poured in efficient wet mixer-granulator, stirring frequency 20Hz is set, unlatching is uniformly mixed 90-150s, after mixing, add polyoxyethylene sorbitan monoleate alcoholic solution, chopping frequency 40Hz is set, opens chopping and granulate, discharging;
(5) dry: the wet granular of granulation gained is evenly split in dry car drip pan on, set temperature 55-65 DEG C, dry total time is 2-3 hour, and after dry, material sieves 40-18 order;
(6) mix: after sieving, granule and flavoring banana essence drop into three-dimensional motion mixer, arrange premixing speed 15 revs/min, incorporation time 10 minutes;
(7) pack: use particles packing machine subpackage.
test example 1:high molecular polymer comparision contents is tested
(1) accelerated test
By following each sample temperature 40 DEG C, place 6 months under relative humidity 75% condition, respectively at the 1st, 2,3, sampling in June, according to " related substance in HPLC method mensuration Cefetamet Pivoxil Hydrochloride and polymer ", [king builds, and wangdan is red, the related substance in big vast sharp Ya .HPLC method mensuration Cefetamet Pivoxil Hydrochloride and polymer (J), pharmaceutical analysis magazine, 2015, (2)] measure the content of polymer in each sample, and with 0 day results contrast.Result of the test is shown in Table 1:
Trial target: the Cefetamet Pivoxil Hydrochloride crystal that the embodiment of the present invention 1 is obtained;
Reference substance: commercially available Cefetamet Pivoxil Hydrochloride raw material, is provided by Zhuhai United Laboratories Ltd.
The content of high molecular polymer in table 1 accelerated test each sample
(2) long term test
Each sample at room temperature, respectively at the 3rd, sampling in 6,9,12 months, according to " related substance in HPLC method mensuration Cefetamet Pivoxil Hydrochloride and polymer ", [king builds, wangdan is red, related substance in flood sharp Ya .HPLC method mensuration Cefetamet Pivoxil Hydrochloride and polymer (J), pharmaceutical analysis magazine, 2015, (2)] measure the content of polymer in each sample, and with 0 day results contrast.Result of the test is shown in Table 2:
The assay result of polymer in table 2 long term test each sample
Find out from above-mentioned result of the test, compared with commercially available prod, the polymer content of cefetamet pivoxil hydrochloride compound crystal of the present invention is lower, good stability, and the content of polymer is along with the prolongation of period of storage, and it increases seldom.
test example 2:antibacterial activity is tested
1, materials and methods
1.1 antibacterial
Certain clinical laboratory of institute is collected in the blood of clinical patient, expectorant, secretions, Urine specimens and isolates 84 strain clinical bacterias, through the qualification of VITEK-AMS microbiological analysis instrument, has 24 strain streptococcus pneumoniae, 23 influenzae strain bacillus, 18 strain enterococcus, 19 strain staphylococcuses.Quality-control strains is provided by Ministry of Public Health Clinical Laboratory center.
1.2 culture medium
Isolation medium is 5% blood plate, and drug test MH agar is purchased from Oxoid company.
1.3 antibacterials
Trial target: the Cefetamet Pivoxil Hydrochloride crystal that the embodiment of the present invention 1 is obtained;
Reference substance: commercially available Cefetamet Pivoxil Hydrochloride raw material, is provided by Zhuhai United Laboratories Ltd.
1.4 criterion
Standard bacteria and tested bacterium drug sensitivity tests judge by NCCLS standard in 2000.
1.5 statistical method
Calculate Sensitivity rate, medium sensitivity rate, the resistant rate of various antibacterials to different bacterium, and use χ
2check the Sensitivity rate of more each Cefetamet Pivoxil Hydrochloride.
2, the results are shown in Table 3, table 4, table 5, table 6
Table 3 cefetamet pivoxil hydrochloride compound is to the pneumococcal antibacterial activity in vitro of 24 strain
Table 4 cefetamet pivoxil hydrochloride compound is to the antibacterial activity in vitro of 23 influenzae strain bacillus
Table 5 cefetamet pivoxil hydrochloride compound is to the enterococcal antibacterial activity in vitro of 18 strain
Table 6 cefetamet pivoxil hydrochloride compound is to the staphylococcic antibacterial activity in vitro of 19 strain
As can be seen from above-mentioned result of the test, the cefetamet pivoxil hydrochloride compound prepared by the present invention has more significant antibacterial activity to streptococcus pneumoniae, hemophilus influenza; Commercially available Cefetamet Pivoxil Hydrochloride is to enterococcus, staphylococcus without antibacterial activity, and Cefetamet Pivoxil Hydrochloride provided by the invention has stronger antibacterial activity to enterococcus, staphylococcus.
Claims (5)
1. treat a medicine Cefetamet Pivoxil Hydrochloride composition granule for bacteriological infection, it is characterized in that: described composition granule is made up of Ro-15-8075, mannitol, carboxymethyl cellulose, glycine, dehydrated alcohol, polyoxyethylene sorbitan monoleate, flavoring banana essence; Described Cefetamet Pivoxil Hydrochloride is crystal, and the X-ray powder diffraction pattern that the measurement of use Cu-K alpha ray obtains as shown in Figure 1.
2. the medicine Cefetamet Pivoxil Hydrochloride composition granule for the treatment of bacteriological infection according to claim 1, is characterized in that: described composition granule is made up of the Cefetamet Pivoxil Hydrochloride of 1.25 weight portions, the mannitol of 0.8-1.2 weight portion, the carboxymethyl cellulose of 0.6-0.8 weight portion, the glycine of 0.3-0.5 weight portion, the dehydrated alcohol of 0.5-0.7 weight portion, the polyoxyethylene sorbitan monoleate of 0.04-0.06 weight portion, the flavoring banana essence of 0.04-0.06 weight portion.
3. the medicine Cefetamet Pivoxil Hydrochloride composition granule for the treatment of bacteriological infection according to claim 2, is characterized in that: described composition granule is made up of the Cefetamet Pivoxil Hydrochloride of 1.25 weight portions, the mannitol of 1.0 weight portions, the carboxymethyl cellulose of 0.7 weight portion, the glycine of 0.4 weight portion, the dehydrated alcohol of 0.6 weight portion, the polyoxyethylene sorbitan monoleate of 0.05 weight portion, the flavoring banana essence of 0.05 weight portion.
4. the medicine Cefetamet Pivoxil Hydrochloride composition granule of the treatment bacteriological infection according to any one of claim 1-3, it is characterized in that, the preparation method of described composition granule comprises the following steps:
(1) supplementary material process: sieve Cefetamet Pivoxil Hydrochloride, mannitol, carboxymethyl cellulose, glycine 80 orders;
(2) weigh: weigh according to prescription;
(3) binding agent preparation: the polyoxyethylene sorbitan monoleate of recipe quantity is dissolved in dehydrated alcohol, stand-by;
(4) granulate: the Cefetamet Pivoxil Hydrochloride taken, mannitol, carboxymethyl cellulose, glycine are poured in efficient wet mixer-granulator, stirring frequency 20Hz is set, unlatching is uniformly mixed 90-150s, after mixing, add polyoxyethylene sorbitan monoleate alcoholic solution, chopping frequency 40Hz is set, opens chopping and granulate, discharging;
(5) dry: the wet granular of granulation gained is evenly split in dry car drip pan on, set temperature 55-65 DEG C, dry total time is 2-3 hour, and after dry, material sieves 40-18 order;
(6) mix: after sieving, granule and flavoring banana essence drop into three-dimensional motion mixer, arrange premixing speed 15 revs/min, incorporation time 10 minutes;
(7) pack: use particles packing machine subpackage.
5. the medicine Cefetamet Pivoxil Hydrochloride composition granule for the treatment of bacteriological infection according to claim 1, it is characterized in that, the preparation method of the crystal of described Cefetamet Pivoxil Hydrochloride comprises the following steps: volume Cefetamet Pivoxil Hydrochloride being dissolved in 35 DEG C is in the ethanol of 10 times of Cefetamet Pivoxil Hydrochloride weight and the mixed solvent of acetone, the volume ratio of ethanol and acetone is 3:1, after dissolving completes, add the iso-butanol solvent that volume is 6 times of Cefetamet Pivoxil Hydrochloride weight, room temperature is reduced the temperature in 1-2 hour, 1 hour is kept in room temperature, then, cool to-5 DEG C to-10 DEG C further again, then, place 3 hours at-5 DEG C to-10 DEG C, crystallize out, namely Cefetamet Pivoxil Hydrochloride crystal is obtained.
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Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101756906A (en) * | 2009-11-02 | 2010-06-30 | 严洁 | Pharmaceutical composition of cefcapene pivoxil hydrochloride granules and preparation method thereof |
| CN102875573A (en) * | 2012-10-15 | 2013-01-16 | 黄金秀 | Cefixime compound and pharmaceutical composition thereof |
| CN104788470A (en) * | 2015-04-30 | 2015-07-22 | 苗怡文 | Cefetamet pivoxil hydrochloride compound for treating sensitive bacteria infectious diseases |
| CN104800221A (en) * | 2015-05-15 | 2015-07-29 | 苗怡文 | Medicinal cefetamet pivoxil hydrochloride composition for treating sensitive bacteria infectious diseases |
| CN104876947A (en) * | 2015-05-06 | 2015-09-02 | 山东罗欣药业集团股份有限公司 | Cefetamet pivoxil hydrochloride hydrate crystals and dispersible tablet thereof |
-
2015
- 2015-09-24 CN CN201510614416.7A patent/CN105078902A/en not_active Withdrawn
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101756906A (en) * | 2009-11-02 | 2010-06-30 | 严洁 | Pharmaceutical composition of cefcapene pivoxil hydrochloride granules and preparation method thereof |
| CN102875573A (en) * | 2012-10-15 | 2013-01-16 | 黄金秀 | Cefixime compound and pharmaceutical composition thereof |
| CN104788470A (en) * | 2015-04-30 | 2015-07-22 | 苗怡文 | Cefetamet pivoxil hydrochloride compound for treating sensitive bacteria infectious diseases |
| CN104876947A (en) * | 2015-05-06 | 2015-09-02 | 山东罗欣药业集团股份有限公司 | Cefetamet pivoxil hydrochloride hydrate crystals and dispersible tablet thereof |
| CN104800221A (en) * | 2015-05-15 | 2015-07-29 | 苗怡文 | Medicinal cefetamet pivoxil hydrochloride composition for treating sensitive bacteria infectious diseases |
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