CN101912368A - Compound cefaclor suspension and preparation method thereof - Google Patents
Compound cefaclor suspension and preparation method thereof Download PDFInfo
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- CN101912368A CN101912368A CN 201010291750 CN201010291750A CN101912368A CN 101912368 A CN101912368 A CN 101912368A CN 201010291750 CN201010291750 CN 201010291750 CN 201010291750 A CN201010291750 A CN 201010291750A CN 101912368 A CN101912368 A CN 101912368A
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- cefaclor
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Abstract
The invention discloses a compound cefaclor suspension and a preparation method thereof, belonging to the field of pharmaceutical preparations. The compound cefaclor suspension comprises the following components in percentage by weight: 4-50 percent of cefaclor, 0.14-1.75 percent of bromhexine hydrochloride, 0.5-6 percent of macromolecule suspending agent, 0.1-1.8 percent of sweetener, 38.45-95.256 percent of cane sugar, 0.003-1 percent of sunset yellow and 0.001-1 percent of flavoring orange essence. The preparation method comprises the following steps of: after uniformly mixing the macromolecule suspending agent sodium carboxymethylcellulose with the cane sugar, adding an ethanol-water solution containing the sunset yellow and the sweetener saccharin sodium; and after preparing a soft material, granulating and drying, uniformly mixing with the cefaclor, the bromhexine hydrochloride and the flavoring orange essence to obtain the compound cefaclor suspension. The compound cefaclor suspension can be used for treating respiratory tract mild-to-severe infection caused by sensitive bacteria, tonsillitis, chronic bronchitis acute exacerbation, pneumonia, nasosinusitis, and the like.
Description
Technical field
The present invention relates to a kind of compound cefaclor dry suspension and preparation method thereof, belong to field of medicine preparations.
Background technology
Cephalosporins is a class wide spectrum semisynthetic antibiotics, has that antibacterial action is strong, penicillin resistant enzyme, toxicity are low, anaphylaxis is than advantages such as penicillin are few.At present, cephalosporins accounts for larger specific gravity in anti-infectives market, the world, and its sales volume accounts for 40% of anti-infectives sales volume at present.
Cefaclor is a second generation cephalosporin, and its mechanism of action is synthetic for suppressing bacteria cell wall.Has a broad antifungal spectrum, effective to golden Portugal bacterium, Hemolytic streptococcus, streptococcus pneumoniae, hemophilus influenza, escherichia coli, proteus mirabilis, klepsiella pneumoniae, gonorrhea naphthalene plucked instrument Salmonella, propionibacterium acnes, bacteroid, dyspepsiacoccus, peptostreptococcus etc.
By the microbial infection of sensitivity; bring out pharyngitis, tonsillitis, acute episode of chronic bronchitis, pneumonia, sinusitis etc. through regular meeting; anti-infectives cefaclor and expectorant Bisolvon are share; make compound preparation; be used for the treatment of above-mentioned sensitive organism and infect the pharyngitis that causes, tonsillitis etc., respond well.
But cefaclor and Bisolvon are poorly soluble in water, and medicine stripping from preparation, are absorbed with the regular hour process, cause drug effect slower.The anti-infectives preparation that presses for clinically is that patient's taking convenience, drug effect are fast, and effect rapidly.We develop a kind of compound cefaclor dry suspension and preparation method thereof, face the time spent to add the water jolting and can be dispersed into for oral suspension, and the rapid stripping of medicine, rapid-action, and dry suspension has advantage easy to carry, that pharmaceutical properties is stable.
Summary of the invention
The present invention seeks in order to solve above-mentioned cefaclor and Bisolvon poorly soluble in water, and medicine stripping from preparation, be absorbed with the regular hour process, cause the slower problem of drug effect and provide a kind of rapid stripping that has, rapid-action compound cefaclor dry suspension and preparation method thereof.
Compound cefaclor dry suspension of the present invention, institute comprises component and percentage by weight is as follows:
Cefaclor 4～50%
Bisolvon 0.14～1.75%
Macromolecule suspending agent 0.5～6%
Sweeting agent 0.1～1.8%
Sucrose 38.45～95.256%
Sunset yellow 0.003～1%
Flavoring orange essence 0.001～1%
Preferred compound cefaclor dry suspension, institute comprises component and percentage by weight is as follows:
Cefaclor 7～25%
Bisolvon 0.25～0.88%
Macromolecule suspending agent 1～5%
Sweeting agent 0.3～1.2%
Sucrose 66.52～91.441%
Sunset yellow 0.006～0.7%
Flavoring orange essence 0.003～0.7%
Compound cefaclor dry suspension of the present invention is characterized in that the mass ratio of cefaclor and Bisolvon is 28.41 in its component.
The agent of macromolecule suspending can increase the viscosity of disperse medium to reduce the sedimentation velocity of microgranule, increases the granule hydrophilic.The agent of selected macromolecule suspending is arabic gum, tragakanta, sodium alginate, one or more in methylcellulose, sodium carboxymethyl cellulose, hydroxypropyl cellulose, carboxymethyl starch sodium, hydroxypropyl emthylcellulose, hydroxyethyl-cellulose, aluminium-magnesium silicate, the aluminium silicate.
Because the principal agent bitter in the mouth needs to add suitable sweeting agent and carries out flavoring in the dry suspension prescription, selected sweeting agent is one or more in aspartame, sucralose, steviosin, the saccharin sodium.
In optimizing prescriptions, the agent of selected macromolecule suspending is a sodium carboxymethyl cellulose, and selected sweeting agent is a saccharin sodium.
At preferred compound cefaclor dry suspension, it is characterized in that institute comprises component and percentage by weight is as follows:
Cefaclor 12.5%
Bisolvon 0.44%
Sodium carboxymethyl cellulose 3.0%
Saccharin sodium 0.7%
Sucrose 83.06%
Sunset yellow 0.2%
Flavoring orange essence 0.1%
A kind of preparation method of compound cefaclor dry suspension also is provided in the optimizing prescriptions in the present invention, has comprised the steps:
(1) take by weighing saccharin sodium, the sunset yellow of recipe quantity, add an amount of 95% ethanol after adding the water stirring and dissolving, it is standby to stir;
(2) sodium carboxymethyl cellulose, sucrose are crossed 80 mesh sieves, standby;
(3) with behind sodium carboxymethyl cellulose and the sucrose mixing, add the above-mentioned ethanol-water solution that contains saccharin sodium, sunset yellow, the system soft material is crossed 30 eye mesh screens and is granulated, 60 ℃ of dryings, and dried granule is crossed 30 order granulate;
(4) granule and cefaclor, Bisolvon equivalent are progressively increased mixing adds the flavoring orange essence mixing at last.
The resulting compound cefaclor dry suspension of above-mentioned preparation method as the treatment because of the microbial respiratory tract of sensitivity slightly to severe infection and pharyngitis, tonsillitis, acute episode of chronic bronchitis, pneumonia, the application of diseases such as sinusitis.
Beneficial effect of the present invention
Because the present invention has adopted the agent of macromolecule suspending, sucrose etc. to medicine disperses, result of extraction is good adjuvant; On preparation method, prepare granules of accessories earlier; again medicine and granules of accessories mixing are made the method for dry suspension; avoid medicine through preparation of granules conditions such as wet, heat, extruding; the medicine of final gained has rapid stripping; rapid-action characteristics, the compound cefaclor dry suspension of gained of the present invention also has advantage easy to carry, that pharmaceutical properties is stable simultaneously.
The specific embodiment
Further illustrate content of the present invention below in conjunction with embodiment, but the present invention is not limited to the scope of following embodiment.
Embodiment 1
The compound cefaclor dry suspension, in 1000 bags, its composition of writing out a prescription:
To prepare 1000 bags is example, and above-mentioned compound cefaclor dry suspension preparation method is as follows:
Take by weighing saccharin sodium, the sunset yellow of recipe quantity, add and add an amount of 95% ethanol after the water stirring and dissolving, it is standby to stir; Sodium carboxymethyl cellulose, sucrose are crossed 80 mesh sieves, standby; Behind sodium carboxymethyl cellulose and sucrose mixing, add the above-mentioned ethanol-water solution that contains saccharin sodium, sunset yellow, the system soft material is crossed 30 eye mesh screens and is granulated, 60 ℃ of dryings, dried granule is crossed 30 order granulate; With granule and cefaclor, the Bisolvon equivalent mixing that progressively increases, add the flavoring orange essence mixing at last, packing (2g/ bag) is promptly.
Get the compound cefaclor dry suspension sample of embodiment 1 gained, by the national drug standards physical and chemical indexs such as medicament contg, Bisolvon uniformity of dosage units, related substance, settling volume ratio, redispersibility, drug dissolution are studied, be the results are shown in following table 1.
Get commercially available Cefaclor dry suspension (cefaclor dry suspension), detect indexs such as its medicine related substance, dissolution, the results are shown in Table 2.
Get commercially available compound cefaclor dry suspension (U.S. excellent pharmaceutical Co. Ltd provides), detect physical and chemical indexs such as its medicament contg, Bisolvon uniformity of dosage units, the results are shown in Table 3.
From the contrast of table 1, table 2 and table 3 as can be seen, because the compound cefaclor dry suspension that prescription involved in the present invention is formed and preparation method obtains, the quality index of product of the present invention is better than commercially available product aspect medicine related substance and stripping index.
In addition, get the compound cefaclor dry suspension sample of embodiment 1 gained, carry out clinical control research.60 routine patients are divided into two groups at random, and test group 30 examples give this product (embodiment 1), and matched group 30 examples give cefaclor dry suspension (Cefaclor), and dosage is with reference to the dosage of cefaclor dry suspension (Cefaclor); Test group and matched group are respectively cure rate 87% to acute respiratory bacterial infection treatment situation, 83%, effective percentage 95%, 92%, bacteria clearance 93%, 93%, the adverse events incidence rate relevant with medicine is respectively 6%, 5%, can draw thus, compound cefaclor dry suspension treatment acute respiratory infection of the present invention has good and clinical curative effect.
Embodiment 2
The compound cefaclor dry suspension, in 1000 bags, its composition of writing out a prescription:
Take by weighing saccharin sodium, the sunset yellow of recipe quantity, add and add an amount of 95% ethanol after the water stirring and dissolving, it is standby to stir; Sodium carboxymethyl cellulose, sucrose are crossed 80 mesh sieves, standby; Behind sodium carboxymethyl cellulose and sucrose mixing, add the above-mentioned ethanol-water solution that contains saccharin sodium, sunset yellow, the system soft material is crossed 30 eye mesh screens and is granulated, 60 ℃ of dryings, dried granule is crossed 30 order granulate; With granule and cefaclor, the Bisolvon equivalent mixing that progressively increases, add flavoring orange essence, micropowder silica gel mixing at last, packing (1g/ bag) is promptly.
Embodiment 3
Cefaclor (1 former medicine), Bisolvon (2 former medicine) are granulated behind the mixing respectively by a certain percentage with relevant auxiliary materials, will make granule and carry out high light (4500Lx), high temperature (40 ℃) and high humidity (RH75%) factors influencing, the results are shown in Table 4.Former as can be seen from Table 4 medicine and each adjuvant factors influencing result show its stability better.
Embodiment 4
Take by weighing saccharin sodium, the sunset yellow of recipe quantity by table 5 prescription, add an amount of 95% ethanol after adding the water stirring and dissolving, it is standby to stir; Sodium carboxymethyl cellulose, sucrose are crossed 80 mesh sieves, standby; Behind sodium carboxymethyl cellulose and sucrose mixing, add the above-mentioned ethanol-water solution that contains saccharin sodium, sunset yellow, the system soft material is crossed 30 eye mesh screens and is granulated, 60 ℃ of dryings, dried granule is crossed 30 order granulate; With granule and cefaclor, the Bisolvon equivalent mixing that progressively increases, add the flavoring orange essence mixing at last, that is, the preparation envionmental humidity is controlled at below 50%.
To investigating the above-mentioned particulate outward appearance of gained of respectively writing out a prescription, mouthfeel, granule angle of repose, settling volume than, redispersibility and granule dissolution, the results are shown in Table 6,6 effects of writing out a prescription as can be seen from Table 6 are best, and mouthfeel is good, dissolution is maximum.
Above said content only is the basic explanation of the present invention under conceiving, and according to any equivalent transformation that technical scheme of the present invention is done, all should belong to protection scope of the present invention.
Claims (8)
1. compound cefaclor dry suspension is characterized in that institute comprises component and percentage by weight is as follows:
Cefaclor 4～50%
Bisolvon 0.14～1.75%
Macromolecule suspending agent 0.5～6%
Sweeting agent 0.1～1.8%
Sucrose 38.45～95.256%
Sunset yellow 0.003～1%
Flavoring orange essence 0.001～1%
The agent of described macromolecule suspending is arabic gum, tragakanta, sodium alginate, one or more mixture in methylcellulose, sodium carboxymethyl cellulose, hydroxypropyl cellulose, carboxymethyl starch sodium, hydroxypropyl emthylcellulose, hydroxyethyl-cellulose, aluminium-magnesium silicate, the aluminium silicate;
Described sweeting agent is one or more mixture in aspartame, sucralose, steviosin, the saccharin sodium.
2. the described a kind of compound cefaclor dry suspension of claim 1 is characterized in that institute comprises component and percentage by weight is as follows:
Cefaclor 7～25%
Bisolvon 0.25～0.88%
Macromolecule suspending agent 1～5%
Sweeting agent 0.3～1.2%
Sucrose 66.52～91.441%
Sunset yellow 0.006～0.7%
Flavoring orange essence 0.003～0.7%.
3. claim 1 or 2 described a kind of compound cefaclor dry suspension is characterized in that the mass ratio of cefaclor and Bisolvon is 28.41 in its component.
4. claim 1 or 2 described a kind of compound cefaclor dry suspension is characterized in that institute comprises component and percentage by weight is as follows:
Cefaclor 12.5%
Bisolvon 0.44%
Sodium carboxymethyl cellulose 3.0%
Saccharin sodium 0.7%
Sucrose 83.06%
Sunset yellow 0.2%
Flavoring orange essence 0.1%.
5. claim 1 or 2 described a kind of compound cefaclor dry suspension is characterized in that the macromolecule suspending agent preferably carboxymethyl cellulose sodium that it is contained.
6. claim 1 or 2 described a kind of compound cefaclor dry suspension is characterized in that the preferred saccharin sodium of its contained sweeting agent.
7. the preparation method of claim 1 or 2 described a kind of compound cefaclor dry suspension is characterized in that
Comprise and be prepared as follows step:
(1) take by weighing saccharin sodium, the sunset yellow of recipe quantity, add an amount of 95% ethanol after adding the water stirring and dissolving, it is standby to be stirred into aqueous solution;
(2) sodium carboxymethyl cellulose, sucrose are crossed 80 mesh sieves, standby;
(3) with behind sodium carboxymethyl cellulose and the sucrose mixing, add the above-mentioned ethanol-water solution that contains saccharin sodium, sunset yellow, the system soft material is crossed 30 eye mesh screens and is granulated, 60 ℃ of dryings, and dried granule is crossed 30 order granulate;
(4) granule and cefaclor, Bisolvon equivalent are progressively increased mixing adds the flavoring orange essence mixing at last.
Claim 1 or 2 described a kind of compound cefaclor dry suspension as the treatment because of the microbial respiratory tract of sensitivity slightly to severe infection and pharyngitis, tonsillitis, acute episode of chronic bronchitis, pneumonia, the application of sinusitis.
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| CN 201010291750 CN101912368A (en) | 2010-09-26 | 2010-09-26 | Compound cefaclor suspension and preparation method thereof |
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| CN 201010291750 CN101912368A (en) | 2010-09-26 | 2010-09-26 | Compound cefaclor suspension and preparation method thereof |
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Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102144975A (en) * | 2010-12-24 | 2011-08-10 | 山东省医药工业研究所 | Cefprozil suspension pharmaceutical composition |
| CN102327269A (en) * | 2011-07-14 | 2012-01-25 | 海南美大制药有限公司 | Solid lipidosome preparation of compound cefaclor medicinal composition |
| CN102525949A (en) * | 2012-01-17 | 2012-07-04 | 山东罗欣药业股份有限公司 | Cefaclor composition particles and preparation method thereof |
| 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 |
| CN105250223A (en) * | 2015-11-06 | 2016-01-20 | 石家庄四药有限公司 | Dry suspension containing Arbidol and salt thereof as well as preparation method of dry suspension |
| CN106619592A (en) * | 2016-11-17 | 2017-05-10 | 郑州郑先医药科技有限公司 | Medicine for treating acute pharyngitis |
| CN107137394A (en) * | 2017-05-11 | 2017-09-08 | 宁波双伟制药有限公司 | Coartem dry suspensoid agent of two-component treatment malaria and preparation method thereof |
| CN107561188A (en) * | 2017-09-27 | 2018-01-09 | 江苏正大清江制药有限公司 | A kind of method of plurality of active ingredients in oneself new dry suspensoid agent of measure clo |
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| CN1666743A (en) * | 2004-03-12 | 2005-09-14 | 黄本东 | Compound cefaclor dispersible tablet |
| 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 |
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| CN1666743A (en) * | 2004-03-12 | 2005-09-14 | 黄本东 | Compound cefaclor dispersible tablet |
| 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 |
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Cited By (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102144975A (en) * | 2010-12-24 | 2011-08-10 | 山东省医药工业研究所 | Cefprozil suspension pharmaceutical composition |
| CN102144975B (en) * | 2010-12-24 | 2012-12-12 | 山东省医药工业研究所 | Cefprozil suspension pharmaceutical composition |
| CN102327269A (en) * | 2011-07-14 | 2012-01-25 | 海南美大制药有限公司 | Solid lipidosome preparation of compound cefaclor medicinal composition |
| CN102525949A (en) * | 2012-01-17 | 2012-07-04 | 山东罗欣药业股份有限公司 | Cefaclor composition particles and preparation method thereof |
| CN102525949B (en) * | 2012-01-17 | 2013-06-05 | 山东罗欣药业股份有限公司 | Cefaclor composition particles and preparation method thereof |
| 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 |
| CN105250223A (en) * | 2015-11-06 | 2016-01-20 | 石家庄四药有限公司 | Dry suspension containing Arbidol and salt thereof as well as preparation method of dry suspension |
| CN110522733A (en) * | 2015-11-06 | 2019-12-03 | 石家庄四药有限公司 | A kind of arbidol and its salt dry suspensoid agent and preparation method thereof |
| CN106619592A (en) * | 2016-11-17 | 2017-05-10 | 郑州郑先医药科技有限公司 | Medicine for treating acute pharyngitis |
| CN107137394A (en) * | 2017-05-11 | 2017-09-08 | 宁波双伟制药有限公司 | Coartem dry suspensoid agent of two-component treatment malaria and preparation method thereof |
| CN107561188A (en) * | 2017-09-27 | 2018-01-09 | 江苏正大清江制药有限公司 | A kind of method of plurality of active ingredients in oneself new dry suspensoid agent of measure clo |
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Open date: 20101215 |