CN102525949A - Cefaclor composition particles and preparation method thereof - Google Patents
Cefaclor composition particles and preparation method thereof Download PDFInfo
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- CN102525949A CN102525949A CN201210014134XA CN201210014134A CN102525949A CN 102525949 A CN102525949 A CN 102525949A CN 201210014134X A CN201210014134X A CN 201210014134XA CN 201210014134 A CN201210014134 A CN 201210014134A CN 102525949 A CN102525949 A CN 102525949A
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Abstract
The invention relates to the technical field of medicine, and discloses cefaclor composition particles and a preparation method thereof. The cefaclor composition particles disclosed by the invention are prepared from the following raw materials in parts by weight: 250 parts of cefaclor, 8 parts of bromhexine hydrochloride, 1,490 parts of sucrose, 20 parts of acesulfame, 2.5 parts of essence and 250 parts of sorbitol. The cefaclor composition particles disclosed by the invention comprise sorbitol which can be taken as a medicament dispersing agent for enhancing the medicament solubility and can be used for enhancing the antibacterial action of cefaclor. As proved by a test, the cefaclor composition particles disclosed by the invention have enhanced antibacterial action and high stability and can be widely applied to treatment of bacterial infection diseases such as respiratory tract infection, bone and joint infection, pelvic infection, abdominal infection and the like.
Description
Technical field
The present invention relates to medical technical field, relate to a kind of cefaclor composition grain and preparation method thereof specifically.
Background technology
Respiratory system infection is one of modal infectious disease clinically, respiratory tract infection that causes like acute and chronic respiratory tract infection, pneumonia, chronic obstructive pulmonary disease, flu etc.According to foreign statistic, the incidence rate of respiratory system infection accounts for more than 60% of the total incidence rate of all kinds of infectious disease.At home, respiratory system infection is first cause of disease that causes rural population dead, also is one of four big killers of causing death in the city.Therefore, the treatment to respiratory system infection is the problem that often faces clinically.
When respiratory tract infection takes place, because respiratory inflammation causes a large amount of secreting mucus such as trachea, bronchus body of gland and trephocyte, and mix some inflammation exudates and exfoliative cyte etc., thereby form sputum.Ciliated cell this moment is impaired, and hypokinesis can not in time be discharged sputum, causes the cough aggravation, increases the weight of to infect and asthma, and a large amount of sputums can also block respiratory tract, cause dyspnea, even suffocate.Therefore, to the treatment of respiratory tract infection, removing needs to use the antimicrobial drug beyond the region of objective existence, also often need be aided with the eliminating phlegm and relieving cough medicine, accelerates the purpose of patient's rehabilitation to reach treating both the principal and secondary aspects of a disease.For a long time; Although anti-infectives and cough-relieving and phlegm-eliminating medicine Combined application clinically are very general, owing to never have the compound preparation supply of rational regular collocation ratio, no matter domestic still external; Clinical treatment can only carry out according to the doctors experience prescription; Use very inconvenience, types of medicines and ratio are also unreasonable, can not guarantee clinical application safety and effectiveness.
Is the compound preparation of the treatment respiratory tract infection of first kind of fixed prescription by U.S. Lilly company at the compound cefaclor preparation of the mid-90 in last century exploitation listing, is made up of the oral cephalo-type antimicrobial drug of strong effect wide-spectrum cefaclor and the strong antisussive and expectorant agent Bisolvon of imitating.Cefaclor is a wide spectrum semi-synthetic cephalosporins antibiotic; Belong to second filial generation oral cephalosporin, have broad-spectrum antibacterial action, multiple gram positive bacteria and gram negative bacteria are all had very strong killing action; Strong, the anti-enzyme of antibacterial action, safety, orally-ingestible, absorption are rapidly and fully; And, be difficult for producing fastbacteria because its construction features is highly stable to beta-lactamase.Bisolvon is a kind of mucus regulator commonly used and sputum lytic agent class expectorant, can make the cracking of apoplexy due to phlegm mucopolysaccharide fiber differentiation, and serous secretion increases, and the thick sputum degree is reduced, and sputum is thinning to be easy to expectoration, makes respiratory passage unblocked.Bisolvon also can increase antimicrobial drug at the respiratory tract distributed density in addition, and is convenient to the infiltration of antimicrobial drug to sputum.Two kinds of medicine couplings produce synergism, can antimicrobial while eliminating phlegm and relieving coughs, and relief of symptoms is cured respiratory system infection rapidly, is a kind of good effect, untoward reaction compound recipe few, easy to use.
Yet existing compound cefaclor preparation majority is tablet and capsule, be unfavorable for swallowing, and dissolution is poor, and it is relatively poor to cause the patient to take compliance.
Summary of the invention
The invention provides a kind of cefaclor composition grain and preparation method thereof, said cefaclor composition grain dissolution is high, and antibacterial action strengthens, and good stability.
The present invention adopts following technical scheme:
A kind of cefaclor composition grain is processed by following weight portion raw material: 250 parts of 250 parts of cefaclors, 8 parts of Bisolvon, 1490 parts of sucrose, 20 parts of acesulfame potassiums, 2.5 parts in essence and sorbitol.
Cefaclor composition grain according to the invention is that raw material is processed by cefaclor, Bisolvon, sucrose, acesulfame potassium, essence and sorbitol.
Cefaclor composition grain according to the invention as wetting agent, can overcome difficulty when granulating with ethanol, avoids the medicine caking.Researcher of the present invention is found to add in the prescription sorbitol through a large amount of tests and not only can be used as the medicine wetting agent; Avoid the medicine caking; Improve drug dissolution; And can also strengthen the antibacterial action of cefaclor, and stability of drug and safety change not quite, reaches safety, the effectiveness of medication.
Sucrose is one of human basic food additive, is photosynthetic primary product, is distributed widely in the plant, and particularly content is high in Radix Betae, Caulis Sacchari sinensis and the fruit.Cefaclor composition grain according to the invention as filler, is used for the weight of filler particles preparation with sucrose, guarantees grain forming.Cefaclor composition grain according to the invention with acesulfame potassium and essence as correctives, to cover the strong bitterness of cefaclor.
Test shows that cefaclor composition grain according to the invention has stronger antibacterial activity, suppresses the minimum inhibitory concentration (MIC, μ g/mL) of about 90% bacterial strain; Staphylococcus aureus 3.13, streptococcus pneumoniae 0.39, micrococcus scarlatinae 0.78, escherichia coli, Klebsiella, proteus mirabilis are equal 3.13, hemophilus influenza 6.25; And stable to penicillinase, to the drug resistance staphylococcus aureus and the effect of hemophilus influenza demonstration excellent antibiotic of ampicillin, amoxicillin.Compare with existing cefaclor granule, cefaclor composition grain antibacterial action according to the invention strengthens.
The present invention also provides a kind of method for preparing of cefaclor composition grain; For getting 20 parts of 250 parts of cefaclors, 8 parts of Bisolvon, 1490 parts of sucrose and acesulfame potassiums; Add in the high speed granulator and mixed 10 minutes; Add sorbitol then and mixed 3 minutes for 250 parts, granulate with waving granulation machine, the wet granular that makes was 65 ℃ of oven dry 25～30 minutes; With the dried granule that makes and 2.5 parts of mixing of essence, promptly get.
Can find out that from above-mentioned technical scheme cefaclor composition grain provided by the invention is processed by cefaclor, Bisolvon, sucrose, acesulfame potassium, essence and sorbitol.Not only can be used as the medicine wetting agent, avoid medicine caking, improve drug dissolution, and can also strengthen the antibacterial action of cefaclor, and stability of drug changes not quite with safety, reach safety, the effectiveness of medication.Test shows that cefaclor composition grain antibacterial action according to the invention strengthens, and good stability, can be widely used in the treatment of respiratory infection diseases.
The specific embodiment
The embodiment of the invention discloses a kind of cefaclor composition grain and preparation method thereof.Those skilled in the art can use for reference this paper content, suitably improve technological parameter and realize.Special needs to be pointed out is that all similarly replace and change apparent to those skilled in the art, they all are regarded as and are included in the present invention.Product of the present invention and method are described through preferred embodiment, and the related personnel obviously can change or suitably change and combination method as herein described in not breaking away from content of the present invention, spirit and scope, realizes and use technology of the present invention.
In order further to understand the present invention, the present invention is elaborated below in conjunction with embodiment.
Embodiment 1: cefaclor composition grain according to the invention
Method for preparing: get in cefaclor 250g, Bisolvon 8g, sucrose 1490g and the acesulfame potassium 20g adding high speed granulator and mixed 10 minutes; Add sorbitol 250g then, mixed 3 minutes, emit granule; Granulate with waving granulation machine; The wet granular that makes changed the wet granular of making in the ebullated dryer over to, 65 ℃ of oven dry 25～30 minutes; With the dried granule that makes and essence 2.5g mixing, granulate, sieve, promptly get.
Embodiment 2: cefaclor composition grain antibacterial action according to the invention
Adopt agar dilution to measure cefaclor compositions according to the invention and the particulate minimum inhibitory concentration of existing cefaclor (MIC); The two adopts the different concentration dilution range to different bacterial strains; With the inoculation of multiple spot dibbler, it is 104CFU that each point contains the bacterium number approximately.Cultivate 24h for 37 ℃, the result is as shown in table 1.
Table 1 antibacterial experiment result
Visible by table 1 result; Cefaclor composition grain according to the invention has stronger antibacterial activity, suppresses the minimum inhibitory concentration (MIC, μ g/mL) of about 90% bacterial strain: staphylococcus aureus 3.13; Streptococcus pneumoniae 0.39; Micrococcus scarlatinae 0.78, escherichia coli, Klebsiella, proteus mirabilis are equal 3.13, hemophilus influenza 6.25; And stable to penicillinase, drug resistance staphylococcus aureus and the effect of hemophilus influenza demonstration excellent antibiotic to ampicillin, amoxicillin show that cefaclor composition grain antibacterial action according to the invention strengthens.
Embodiment 3: cefaclor composition grain antibacterial action according to the invention clinical research
Respiratory tract infection, urinary tract infection, skin soft-tissue infection patient due to the 2000 routine sensitive bacterials are divided into treatment A group, treatment B group and matched group at random.Treatment group A gives existing compound cefaclor tablet on the basis of conventional therapy; Treatment group B gives the cefaclor composition grain of the embodiment of the invention 1 preparation on the basis of conventional therapy, every day 2 times, each 300mg; The course of treatment 10d, matched group gives cefalexin.Statistics is respectively organized bacteria clearance, and the result sees table 2.
The clinical research of table 2 antibacterial action
| Matched group | Treatment A group | Treatment B group | |
| Bacteria clearance | / | 93.6％ | 97.5％ |
| Obvious effective rate | / | 55.4％ | 65.1％ |
| Effective percentage | / | 93％ | 95％ |
Visible by table 2 result; Treatment group patient bacteria clearance, treatment obvious effective rate and effective percentage all are significantly higher than matched group; And treatment B group is that cefaclor composition grain group obvious effective rate according to the invention and effective percentage promptly have the compound cefaclor tablet now apparently higher than treatment A group, shows that cefaclor composition grain according to the invention can strengthen antibacterial action.
Embodiment 3: cefaclor composition grain stability study according to the invention
With the embodiment of the invention 1 prepared cefaclor composition grain is object of study, carries out comprehensive study on the stability, comprising: accelerated test, long-time stability.Each study on the stability experimental condition and visible foreign matters inspection method are all with reference to " long-time stability were investigated to 24 months for the relevant regulations in the Chinese pharmacopoeia appendix, accelerated test investigation 6 months, and the result sees table 3～4.
Table 3 accelerated test
Annotate: 40 ℃ ± 2 ℃ of temperature, relative humidity 75% ± 5%
Table 4 long-term stable experiment
Annotate: 20 ℃ ± 2 ℃ of temperature, relative humidity 60% ± 10%
Can know that by table 3～4 results the prepared cefaclor composition grain of the embodiment of the invention 1 is investigated 6 months at 40 ℃ under the acceleration environment of relative humidity 75%; At 20 ℃ ± 2 ℃; Investigate 24 months under relative humidity 60% ± 10% condition, main quality index does not have significant change, shows that cefaclor composition grain according to the invention is stable and controllable for quality; Good stability, safe.
The explanation of above embodiment just is used for helping to understand method of the present invention and core concept thereof.Should be pointed out that for those skilled in the art, under the prerequisite that does not break away from the principle of the invention, can also carry out some improvement and modification to the present invention, these improvement and modification also fall in the protection domain of claim of the present invention.
Claims (2)
1. a cefaclor composition grain is characterized in that, is processed by following weight portion raw material: 250 parts of 250 parts of cefaclors, 8 parts of Bisolvon, 1490 parts of sucrose, 20 parts of acesulfame potassiums, 2.5 parts in essence and sorbitol.
2. the method for preparing of the said cefaclor composition grain of claim 1; It is characterized in that; Get 20 parts of 250 parts of cefaclors, 8 parts of Bisolvon, 1490 parts of sucrose and acesulfame potassiums, add in the high speed granulator and mixed 10 minutes, add sorbitol then and mixed 3 minutes for 250 parts; Granulate with waving granulation machine, the wet granular that makes was 65 ℃ of oven dry 25～30 minutes; With the dried granule that makes and 2.5 parts of mixing of essence, promptly get.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105085549A (en) * | 2015-09-01 | 2015-11-25 | 山东罗欣药业集团股份有限公司 | Cefaclor compound, medicine composition of cefaclor compound and bromhexine hydrochloride, and preparation of cefaclor compound |
| CN106109421A (en) * | 2016-07-15 | 2016-11-16 | 江西亿友药业有限公司 | A kind of Bisolvon granule and preparation technology thereof |
| CN114191375A (en) * | 2021-12-20 | 2022-03-18 | 广东金城金素制药有限公司 | Cefuroxime sodium for injection and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101836994A (en) * | 2010-06-01 | 2010-09-22 | 哈尔滨誉衡药业股份有限公司 | Compound oral preparation of cefaclor and bromhexine and preparation method thereof |
| CN101912368A (en) * | 2010-09-26 | 2010-12-15 | 上海理工大学 | Compound cefaclor suspension and preparation method thereof |
| CN102114019A (en) * | 2009-12-30 | 2011-07-06 | 汤明昌 | Compound cefaclor preparation and preparation method |
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102114019A (en) * | 2009-12-30 | 2011-07-06 | 汤明昌 | Compound cefaclor preparation and preparation method |
| CN101836994A (en) * | 2010-06-01 | 2010-09-22 | 哈尔滨誉衡药业股份有限公司 | Compound oral preparation of cefaclor and bromhexine and preparation method thereof |
| CN101912368A (en) * | 2010-09-26 | 2010-12-15 | 上海理工大学 | Compound cefaclor suspension and preparation method thereof |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105085549A (en) * | 2015-09-01 | 2015-11-25 | 山东罗欣药业集团股份有限公司 | Cefaclor compound, medicine composition of cefaclor compound and bromhexine hydrochloride, and preparation of cefaclor compound |
| CN106109421A (en) * | 2016-07-15 | 2016-11-16 | 江西亿友药业有限公司 | A kind of Bisolvon granule and preparation technology thereof |
| CN114191375A (en) * | 2021-12-20 | 2022-03-18 | 广东金城金素制药有限公司 | Cefuroxime sodium for injection and preparation method thereof |
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Address after: Seven of 276017 Shandong province Linyi city Luozhuang District Patentee after: Shandong Luo Xin Pharmaceutical Group Plc Address before: Seven of 276017 Shandong province Linyi city Luozhuang District Patentee before: SHANDONG LUOXIN PHARMACY STOCK Co., LTD. |