CN102525949B - Cefaclor composition particles and preparation method thereof - Google Patents
Cefaclor composition particles and preparation method thereof Download PDFInfo
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- CN102525949B CN102525949B CN 201210014134 CN201210014134A CN102525949B CN 102525949 B CN102525949 B CN 102525949B CN 201210014134 CN201210014134 CN 201210014134 CN 201210014134 A CN201210014134 A CN 201210014134A CN 102525949 B CN102525949 B CN 102525949B
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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 specifically a kind of cefaclor composition particles and preparation method thereof.
Background technology
Respiratory system infection is one of modal infectious disease clinically, respiratory tract infection that causes as 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 death, is also one of four large killers of causing death in the city.Therefore, be the problem that often faces clinically to the treatment of respiratory system infection.
When respiratory tract infection occurs, due to respiratory inflammation, cause a large amount of secreting mucus such as trachea, bronchus body of gland and trephocyte, and adulterate 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, except needing to use the antimicrobial drug beyond the region of objective existence, also often need be aided with the eliminating phlegm and relieving cough medicine, accelerate the purpose of 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 use in conjunction clinically are very general, but due to the compound preparation supply that never has rational regular collocation ratio, no matter domestic or external, clinical treatment can only carry out according to the doctors experience prescription, use very inconveniently, types of medicines and ratio are also unreasonable, can not guarantee safety and the effectiveness of clinical application.
Be the compound preparation of the treatment respiratory tract infection of the first fixed prescription by U.S. Lilly company at the compound cefaclor preparation of the mid-90 in last century exploitation listing, formed by strong effect wide-spectrum oral cephalo-type antimicrobial drug cefaclor and potent antisussive and expectorant agent Bisolvon.Cefaclor is wide spectrum semi-synthetic cephalosporins antibiotic, belong to second filial generation oral cephalosporin, has broad-spectrum antibacterial action, multiple gram positive bacteria and gram negative bacteria all had very strong killing action, antibacterial action is strong, anti-enzyme, safety, can be oral, absorb rapidly and fully, and due to its construction features, highly stable to beta-lactamase, be difficult for producing fastbacteria.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 Study On Fiber Differentiation, and serous secretion increases, and the thick sputum degree is reduced, and sputum is thinning is 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 antimicrobial drug to the infiltration of sputum.Two kinds of medicine couplings produce synergism, can antimicrobial while eliminating phlegm and relieving coughs, and relief of symptoms, cure 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 the Tablet and Capsula agent, be unfavorable for swallowing, and dissolution is poor, causes the patient to take compliance relatively poor.
Summary of the invention
The invention provides a kind of cefaclor composition particles and preparation method thereof, described cefaclor composition particles dissolution is high, and antibacterial action strengthens, and good stability.
The present invention adopts following technical scheme:
A kind of cefaclor composition particles is made 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, essence and sorbitol.
Cefaclor composition particles of the present invention is that raw material is made by cefaclor, Bisolvon, sucrose, acesulfame potassium, essence and sorbitol.
Cefaclor composition particles of the present invention as wetting agent, can overcome difficulty when granulating with ethanol, avoids the medicine caking.Researcher of the present invention is found to add sorbitol not only to can be used as the medicine wetting agent in prescription by lot of experiments, avoid the medicine caking, improve drug dissolution, and can also strengthen the antibacterial action of cefaclor, and the stability of medicine and safety change little, reach safety, the effectiveness of medication.
Sucrose is one of basic food additive of the mankind, is photosynthetic primary product, is distributed widely in plant, and particularly in Radix Betae, Caulis Sacchari sinensis and fruit, content is high.Cefaclor composition particles of the present invention as filler, is used for the weight of filler particles preparation with sucrose, guarantees grain forming.Cefaclor composition particles of the present invention with acesulfame potassium and essence as correctives, to cover the strong bitterness of cefaclor.
Test shows, cefaclor composition particles of the present invention has stronger antibacterial activity, suppresses the approximately minimum inhibitory concentration of 90% bacterial strain (MIC, μ g/mL); 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 resistant Staphylococcus aureus and the good antibacterial action of hemophilus influenza demonstration of ampicillin, amoxicillin.With existing cefaclor Particle Phase ratio, cefaclor composition particles antibacterial action of the present invention strengthens.
The present invention also provides a kind of preparation method of cefaclor composition particles, for getting 20 parts of 250 parts of cefaclors, 8 parts of Bisolvon, 1490 parts of sucrose and acesulfame potassiums, add in high speed granulator and mixed 10 minutes, then add 250 parts of sorbitol to mix 3 minutes, granulate with oscillating granulator, the wet granular that makes was 65 ℃ of oven dry 25～30 minutes; With dried granule and the 2.5 parts of mixing of essence that make, and get final product.
Can find out from above-mentioned technical scheme, cefaclor composition particles provided by the invention is made 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 the stability of medicine and safety change not quite, reach safety, the effectiveness of medication.Test shows, cefaclor composition particles antibacterial action of the present 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 particles 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, all similarly replace and change apparent to those skilled in the art, and they all are deemed to be included in the present invention.Product of the present invention and method are described by preferred embodiment, and the related personnel obviously can change method as herein described within not breaking away from content of the present invention, spirit and scope or suitably change and combination, realizes and use the technology of the present invention.
In order further to understand the present invention, the present invention is described in detail below in conjunction with embodiment.
Embodiment 1: cefaclor composition particles of the present invention
Preparation method: get cefaclor 250g, Bisolvon 8g, sucrose 1490g and acesulfame potassium 20g and add in high speed granulator and to mix 10 minutes, then add sorbitol 250g, mixed 3 minutes, emit granule, granulate with oscillating granulator, the wet granular that makes changed the wet granular of making in ebullated dryer over to, 65 ℃ of oven dry 25～30 minutes; With the dried granule and essence 2.5g mixing, the granulate that make, sieve, and get final product.
Embodiment 2: cefaclor composition particles antibacterial action of the present invention
Adopt agar dilution to measure the minimum inhibitory concentration (MIC) of cefaclor compositions of the present invention and existing cefaclor granule, both different bacterial strains is adopted different concentration dilution scopes, with the inoculation of multiple spot dibbler, it is 104CFU that each point approximately contains the bacterium number.Cultivate 24h for 37 ℃, result is as shown in table 1.
Table 1 antibacterial experiment result
By table 1 result as seen, cefaclor composition particles of the present invention has stronger antibacterial activity, suppress the approximately minimum inhibitory concentration (MIC of 90% bacterial strain, μ g/mL): 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, resistant Staphylococcus aureus and the good antibacterial action of hemophilus influenza demonstration to ampicillin, amoxicillin show that cefaclor composition particles antibacterial action of the present invention strengthens.
Embodiment 3: cefaclor composition particles antibacterial action of the present invention clinical research
Respiratory tract infection, urinary tract infection, skin soft-tissue infection patient due to 2000 routine sensitive bacterials are divided into treatment A group, treatment B group and matched group at random.Treatment group A gives existing Compound cefacior tablets agent on the basis of conventional therapy, treatment group B gives the cefaclor composition particles of the embodiment of the present invention 1 preparation on the basis of conventional therapy, every day 2 times, each 300mg, the course for the treatment of 10d, matched group gives cefalexin.Statistics is respectively organized bacteria clearance, the results are shown in 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％ |
By table 2 result as seen, treatment group patient's bacteria clearance, treatment obvious effective rate and effective percentage all are significantly higher than matched group, and treatment B group is that cefaclor composition particles group obvious effective rate of the present invention and effective percentage namely have the Compound cefacior tablets agent now apparently higher than treatment A group, shows that cefaclor composition particles of the present invention can strengthen antibacterial action.
Embodiment 3: cefaclor composition particles stability study of the present invention
Take the prepared cefaclor composition particles of the embodiment of the present invention 1 as object of study, carry 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, the results are shown in Table 3～4 for the relevant regulations in the Chinese pharmacopoeia appendix, accelerated test investigation 6 months.
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%
By table 3～4 results as can be known, the prepared cefaclor composition particles of the embodiment of the present invention 1 is at 40 ℃, investigate 6 months under the acceleration environment of relative humidity 75%, at 20 ℃ ± 2 ℃, investigate 24 months under relative humidity 60% ± 10% condition, main quality index shows that without significant change cefaclor composition particles of the present 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 particles, is characterized in that, made 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, essence and sorbitol.
2. the preparation method of the described cefaclor composition particles 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 high speed granulator and mixed 10 minutes, then add 250 parts of sorbitol to mix 3 minutes, granulate with oscillating granulator, the wet granular that makes was 65 ℃ of oven dry 25～30 minutes; With dried granule and the 2.5 parts of mixing of essence that make, and get final product.
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| CN105085549B (en) * | 2015-09-01 | 2017-08-15 | 山东罗欣药业集团股份有限公司 | The pharmaceutical composition and its preparation of a kind of Cefaclor compound, the compound and bromhexine hydrochloride |
| CN106109421B (en) * | 2016-07-15 | 2017-08-25 | 江西亿友药业有限公司 | A kind of bromhexine hydrochloride granule and its preparation technology |
| CN114191375B (en) * | 2021-12-20 | 2022-07-26 | 广东金城金素制药有限公司 | Cefuroxime sodium for injection and preparation method thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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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| 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 |
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Owner name: SHANDONG LUOXIN PHARMACY GROUP CO., LTD. Free format text: FORMER NAME: SHANDONG LUOXIN PHARMACY STOCK CO., LTD. |
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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. |