CN104688713A - Cefradine capsule and preparation method thereof - Google Patents
Cefradine capsule and preparation method thereof Download PDFInfo
- Publication number
- CN104688713A CN104688713A CN201510124640.8A CN201510124640A CN104688713A CN 104688713 A CN104688713 A CN 104688713A CN 201510124640 A CN201510124640 A CN 201510124640A CN 104688713 A CN104688713 A CN 104688713A
- Authority
- CN
- China
- Prior art keywords
- cefradine
- pregelatinized starch
- microcrystalline cellulose
- capsule
- capsules
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Withdrawn
Links
Abstract
The invention provides a cefradine capsule and a preparation method thereof. The capsule comprises the following components in weight percentage: 70-90 wt% of cefradine, 5-15 wt% of partial pregelatinized starch, 5-15 wt% of microcrystalline cellulose and 0.1-1 wt% of magnesium stearate. The components in the capsule have good compatibility; the prepared cefradine capsule is good in dissolution and high in stability; the provided preparation method is simple in process and easy in quality control.
Description
Technical field
The invention belongs to medical art, be specifically related to a kind of Cefradine Capsules agent and preparation method thereof.
Background technology
Cephalosporins is the semisynthetic antibiotics connecting different side chain and make on 7-amino-cephalosporanic acid (7-ACA) parent nucleus of cephalosporin.This class antibiotic has has a broad antifungal spectrum, sterilizing power and stablizes by force, to gastric acid and to beta-lactamase, the advantages such as anaphylaxis is few.Different according to its antibacterial action feature and clinical practice, can be divided into four generation cephalosporin.
Cefradine belongs to first generation cephalosporin, and be white or off-white color crystalline powder, micro-smelly, slightly molten in water, almost insoluble in ethanol, chloroform, ether, its structural formula is as follows:
Cefradine acid resistance is good, can be oral, and good absorbing, blood drug level is higher, and resistance to beta lactamase is better.Cefradine has bactericidal action rapidly and reliably to drug resistance S. aureus L-forms and other multiple bacillus to broad ectrum antibiotic drug resistance etc., can be distributed widely in body tissue, and in vivo not easily by metabolism, active high, mainly from renal excretion, concentration in urine is higher.The clinical infection being mainly used in urinary system that staphylococcus, streptococcus, streptococcus pneumoniae, escherichia coli, pneumobacillus, dysentery bacterium, salmonella etc. cause, respiratory system, digestive system, diseases of eye, ear, nose and throat section, surgery and department of obstetrics and gynecology.
Cefradine is beta-lactam antibiotic, and unstable chemcial property, is easily hydrolyzed, and to sensitive, therefore should not adopt wet granulation technique.
Summary of the invention
For improving the stability of Cefradine Capsules, improving the quality of products, the invention provides a kind of prescription composition and preparation method of Cefradine Capsules.
Concrete technical scheme provided by the invention is as follows:
A kind of Cefradine Capsules agent, it is characterized in that described capsule composition and percentage by weight be: cefradine 70 ~ 90%, partially pregelatinized starch 5 ~ 15%, microcrystalline Cellulose 5 ~ 15%, magnesium stearate 0.1 ~ 1%.
Its preparation method is as follows:
(1) dry: partially pregelatinized starch, microcrystalline Cellulose to be put in heated-air circulation oven 100 ± 5 DEG C of dryings 2 hours;
(2) sieve: cefradine, magnesium stearate are crossed 20 ~ 40 mesh sieves, after dry, after microcrystalline Cellulose and partially pregelatinized starch, cross 40 ~ 60 mesh sieves;
(3) mix: the powder taking each supplementary material of step (2) gained by recipe quantity, by cefradine, microcrystalline Cellulose and partially pregelatinized starch abundant mix homogeneously in mixer, then add magnesium stearate, mixing, obtains content needed for filling capsule;
(4) filling: the content that step (3) is obtained is pressed loading and load in Capsules, control content uniformity, obtained Cefradine Capsules, inspection;
(5) pack: the capsule after detection of learning from else's experience is qualified, Aluminium-coating Packer is packed, warehouse-in.
The stripping of the Cefradine Capsules prepared by above prescription composition provided by the invention and preparation technology is good, and adjuvant can not produce harmful effect to crude drug, and stability is high, the preparation technology provided is simple and easy to do, and impurity is few, and quality is easy to control, technique favorable reproducibility, is applicable to large-scale production.
Partially pregelatinized starch has the overall characteristic of corn starch and full pregelatinized Starch, has the function of binding agent, disintegrating agent, fluidizer and lubricant, and it has low water activity simultaneously, can improve the stability of moisture sensitive drags.
Partially pregelatinized starch and microcrystalline Cellulose with the use of the medicated powder that can obtain good fluidity, simultaneously because microcrystalline Cellulose is also a kind of multi-functional auxiliary material, have the function of filler, disintegrating agent and binding agent, the common use of two kinds of disintegrating agents can the better dissolution that must improve this product.
In addition, partially pregelatinized starch and magnesium stearate with the use of, significantly improve mobility and the lubricant effect of medicated powder, overcome the shortcoming that when being used alone magnesium stearate, medicated powder mobility is not good.
The mode that preparation method provided by the present invention adopts supplementary material directly to mix, without the need to processes such as heating, granulations, operating process is comparatively simple, can greatly enhance productivity, and reduces production cost.And because production process is without heating and the impact of moisture, effectively ensure that the stability of crude drug, avoid the impact on product such as moisture content, high temperature, improve the stability of product.After capsule disintegrates, medicine directly discharges from powder, and the coefficient of dispersion is large, is conducive to improving dissolution.
Detailed description of the invention
Following exemplary embodiments is used for illustrating the present invention, and the simple replacement or improvement etc. done the present invention those skilled in the art all belong within the technical scheme that the present invention protects.
Embodiment 1:
A kind of Cefradine Capsules, its prescription is composed as follows:
Preparation method:
(1) dry: partially pregelatinized starch, microcrystalline Cellulose to be put in heated-air circulation oven 100 ± 5 DEG C of dryings 2 hours;
(2) sieve: cefradine, magnesium stearate are crossed 20 mesh sieves, after dry, after microcrystalline Cellulose and partially pregelatinized starch, cross 40 mesh sieves;
(3) mix: the powder taking each supplementary material of step (2) gained by recipe quantity, cefradine, microcrystalline Cellulose and partially pregelatinized starch are mixed 20 minutes in mixer, abundant mix homogeneously, then magnesium stearate is added, mix 5 minutes, obtain content needed for filling capsule;
(4) filling: the content that step (3) is obtained is pressed loading and load in Capsules, control content uniformity within ± 10%, obtained Cefradine Capsules, inspection;
(5) pack: the capsule after detection of learning from else's experience is qualified, Aluminium-coating Packer is packed, warehouse-in.
Embodiment 2:
A kind of Cefradine Capsules, its prescription is composed as follows:
Preparation method:
(1) dry: partially pregelatinized starch, microcrystalline Cellulose to be put in heated-air circulation oven 100 ± 5 DEG C of dryings 2 hours;
(2) sieve: cefradine, magnesium stearate are crossed 20 mesh sieves, after dry, after microcrystalline Cellulose and partially pregelatinized starch, cross 40 mesh sieves;
(3) mix: the powder taking each supplementary material of step (2) gained by recipe quantity, cefradine, microcrystalline Cellulose and partially pregelatinized starch are mixed 20 minutes in mixer, abundant mix homogeneously, then magnesium stearate is added, mix 5 minutes, obtain content needed for filling capsule;
(4) filling: the content that step (3) is obtained is pressed loading and load in Capsules, control content uniformity within ± 10%, obtained Cefradine Capsules, inspection;
(5) pack: the capsule after detection of learning from else's experience is qualified, Aluminium-coating Packer is packed, warehouse-in.
Embodiment 3:
A kind of Cefradine Capsules, its prescription is composed as follows:
Preparation method:
(1) dry: partially pregelatinized starch, microcrystalline Cellulose to be put in heated-air circulation oven 100 ± 5 DEG C of dryings 2 hours;
(2) sieve: cefradine, magnesium stearate are crossed 20 mesh sieves, after dry, after microcrystalline Cellulose and partially pregelatinized starch, cross 40 mesh sieves;
(3) mix: the powder taking each supplementary material of step (2) gained by recipe quantity, cefradine, microcrystalline Cellulose and partially pregelatinized starch are mixed 20 minutes in mixer, abundant mix homogeneously, then magnesium stearate is added, mix 5 minutes, obtain content needed for filling capsule;
(4) filling: the content that step (3) is obtained is pressed loading and load in Capsules, control content uniformity within ± 7.5%, obtained Cefradine Capsules, inspection;
(5) pack: the capsule after detection of learning from else's experience is qualified, Aluminium-coating Packer is packed, warehouse-in.
Embodiment 4: stripping curve is tested
Get the sample preparing gained by embodiment 1,2 and 3, according to dissolution method (Chinese Pharmacopoeia 2010 editions two annex XC first methods), with 0.1mol/L hydrochloric acid solution 900ml for dissolution medium, rotating speed is 100 turns per minute.Respectively at getting solution 10ml (supplement the isopyknic dissolution medium of isothermal) when 3min, 5min, 10min, 15min simultaneously, filter, get subsequent filtrate 1ml to 10ml measuring bottle and add 0.1mol/L hydrochloric acid solution and be diluted to scale, as need testing solution; Separately get reference substance appropriate, add stripping medium dissolves and quantitatively dilute the solution made containing 25 μ g in every 1ml, product solution in contrast, according to ultraviolet visible spectrophotometry, measure absorbance at the wavelength place of 255nm, calculate accumulative dissolution, concrete dissolution data is in table 1.
Table 1 embodiment 1,2,3 gained Cefradine Capsules accumulative dissolution (%), n=6
| 3min | 5min | 10min | 15min | |
| Embodiment 1 | 80.6±7.4 | 96.3±1.7 | 98.3±2.3 | 99.2±0.8 |
| Embodiment 2 | 57.5±13.5 | 90.7±3.3 | 99.2±1.3 | 99.4±0.3 |
| Embodiment 3 | 35.7±12.4 | 75.1±5.7 | 91.6±3.0 | 98.3±1.0 |
The Cefradine Capsules sample prepared by embodiment 2 and formerly grind the comparative study of Cefradine Capsules dissolution in table 2.
Table 2 embodiment 2 and formerly grind Cefradine Capsules accumulative dissolution (%), n=6
| 3min | 5min | 10min | 15min | |
| Embodiment 2 | 57.5±13.5 | 90.7±3.3 | 99.2±1.3 | 99.4±0.3 |
| Formerly grind product | 60.2±8.9 | 93.6±2.2 | 99.0±0.4 | 99.6±0.1 |
Rapid in the stripping of 0.1mol/L hydrochloric acid solution by table 1 and 2 known Cefradine Capsules, 10min stripping is complete, with former to grind product stripping consistent.
Embodiment 5: stability test
Adopt the prescription of embodiment 2 and preparation method to prepare Cefradine Capsules, and to place at 40 DEG C ± 2 DEG C/75%RH ± 5%RH compare June with the former product that grind.The method in " Chinese Pharmacopoeia " version two in 2010 is wherein all adopted about detection methods such as content, moisture, related substances.Result of the test is in table 3, table 4 and table 5.
Table 3 accelerated test 0 month
Note [1]: 7-ADCA is 7-glycyl oxygen base Cephalosporanic acid.
Table 4 accelerated test March
Table 5 accelerated test June
The result of table 3 ~ 5 shows, the Cefradine Capsules prepared by technical scheme provided by the invention is adopted to place 6 months under 40 DEG C ± 2 DEG C/75%RH ± 5%RH condition, content does not almost change, and moisture and related substance slightly increase, and drug quality is with former to grind product consistent.
Claims (2)
1. a Cefradine Capsules agent, it is characterized in that described capsule composition and percentage by weight be: cefradine 70 ~ 90%, partially pregelatinized starch 5 ~ 15%, microcrystalline Cellulose 5 ~ 15%, magnesium stearate 0.1 ~ 1%.
2. a kind of Cefradine Capsules agent according to claim 1, its preparation method is as follows:
(1) dry: partially pregelatinized starch, microcrystalline Cellulose to be put in heated-air circulation oven 100 ± 5 DEG C of dryings 2 hours;
(2) sieve: cefradine, magnesium stearate are crossed 20 ~ 40 mesh sieves, after dry, after microcrystalline Cellulose and partially pregelatinized starch, cross 40 ~ 60 mesh sieves;
(3) mix: the powder taking each supplementary material of step (2) gained by recipe quantity, by cefradine, microcrystalline Cellulose and partially pregelatinized starch abundant mix homogeneously in mixer, then add magnesium stearate, mixing, obtains content needed for filling capsule;
(4) filling: the content that step (3) is obtained is pressed loading and load in Capsules, control content uniformity, obtained Cefradine Capsules, inspection;
(5) pack: the capsule after detection of learning from else's experience is qualified, Aluminium-coating Packer is packed, warehouse-in.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510124640.8A CN104688713A (en) | 2015-03-20 | 2015-03-20 | Cefradine capsule and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510124640.8A CN104688713A (en) | 2015-03-20 | 2015-03-20 | Cefradine capsule and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN104688713A true CN104688713A (en) | 2015-06-10 |
Family
ID=53336545
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201510124640.8A Withdrawn CN104688713A (en) | 2015-03-20 | 2015-03-20 | Cefradine capsule and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN104688713A (en) |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107496430A (en) * | 2017-09-13 | 2017-12-22 | 南通荣成医药化工有限公司 | A kind of Cefradine pharmaceutical composition |
| CN112206217A (en) * | 2020-10-21 | 2021-01-12 | 迪沙药业集团有限公司 | Cefradine pharmaceutical composition and preparation method thereof |
| CN112933061A (en) * | 2021-02-22 | 2021-06-11 | 石家庄四药有限公司 | Arbidol hydrochloride capsule and preparation method thereof |
| CN112972416A (en) * | 2021-03-30 | 2021-06-18 | 海南海力制药有限公司 | Preparation method of cefradine capsule |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3819620A (en) * | 1972-06-01 | 1974-06-25 | Squibb & Sons Inc | 7-(d-alpha-amino-1,4-cyclohexadien-1-ylacet-amido)desacetoxycephalosporanic acid dihydrate |
| CN1663614A (en) * | 2005-02-04 | 2005-09-07 | 北京阜康仁生物制药科技有限公司 | Compound ambroxol and cephalosporins preparation and application thereof |
| CN102488693A (en) * | 2011-11-30 | 2012-06-13 | 河南工业大学 | Broad spectrum and efficient composite antibacterial agent and preparation method thereof |
-
2015
- 2015-03-20 CN CN201510124640.8A patent/CN104688713A/en not_active Withdrawn
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3819620A (en) * | 1972-06-01 | 1974-06-25 | Squibb & Sons Inc | 7-(d-alpha-amino-1,4-cyclohexadien-1-ylacet-amido)desacetoxycephalosporanic acid dihydrate |
| CN1663614A (en) * | 2005-02-04 | 2005-09-07 | 北京阜康仁生物制药科技有限公司 | Compound ambroxol and cephalosporins preparation and application thereof |
| CN102488693A (en) * | 2011-11-30 | 2012-06-13 | 河南工业大学 | Broad spectrum and efficient composite antibacterial agent and preparation method thereof |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107496430A (en) * | 2017-09-13 | 2017-12-22 | 南通荣成医药化工有限公司 | A kind of Cefradine pharmaceutical composition |
| CN112206217A (en) * | 2020-10-21 | 2021-01-12 | 迪沙药业集团有限公司 | Cefradine pharmaceutical composition and preparation method thereof |
| CN112933061A (en) * | 2021-02-22 | 2021-06-11 | 石家庄四药有限公司 | Arbidol hydrochloride capsule and preparation method thereof |
| CN112972416A (en) * | 2021-03-30 | 2021-06-18 | 海南海力制药有限公司 | Preparation method of cefradine capsule |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN104688713A (en) | Cefradine capsule and preparation method thereof | |
| CN104800221A (en) | Medicinal cefetamet pivoxil hydrochloride composition for treating sensitive bacteria infectious diseases | |
| CN103083278A (en) | Roxithromycin capsule and preparation method thereof | |
| CN107095857A (en) | The production technology of Biomox | |
| CN103446075B (en) | A kind of Cefaclor Capsules and preparation method thereof | |
| CN103110596B (en) | Cefprozil dispersible tablet and preparation method thereof | |
| CN105920016A (en) | Cefalexin tablet composition | |
| CN107375247B (en) | Tilmicosin film-controlled enteric sustained-release preparation and preparation method thereof | |
| CN105343028A (en) | Medicine composition with norfloxacin and method for preparing medicine composition | |
| CN102525948A (en) | Dry suspension of cefpodoxime proxetil composition and preparation method thereof | |
| CN100391456C (en) | Beta-cyclodextrin / amoxicillin inclusion compound and its composition with clavulanic kalium and preparation thereof | |
| CN109432092B (en) | Compound antibacterial preparation in lactation period and preparation method and application thereof | |
| CN103145733A (en) | Amoxicillin compound and pharmaceutical composition of amoxicillin compound and potassium clavulanate | |
| CN103284958B (en) | A kind of Cefdinir composition granule and preparation method thereof | |
| CN105919960B (en) | A kind of roxithromycin dispersing tablet and preparation method thereof | |
| CN102406614A (en) | Amoxicillin potassium clavulanate powder injection and preparation method thereof | |
| CN100415230C (en) | Dispersion tablets of penicillin V potassium, and its preparing method | |
| CN104173310A (en) | Stable amoxicillin tablet composition, as well as preparation method and application thereof | |
| CN107929258A (en) | A kind of plant hollow capsule | |
| CN103432076A (en) | Cefprozil dry suspension and preparation method thereof | |
| CN106310286B (en) | Tosufloxacin tosylate composition | |
| CN105078920B (en) | A kind of azithromycin capsule and preparation method thereof | |
| CN106924198A (en) | Doxycycline hydrochloride oral disintegrating tablet for domestic fowls and preparation method thereof | |
| CN105640895A (en) | Cefadroxil granular preparation and preparation method thereof | |
| CN104546862A (en) | Ceftibuten pharmaceutical composition and preparation method thereof |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| WW01 | Invention patent application withdrawn after publication | ||
| WW01 | Invention patent application withdrawn after publication |
Application publication date: 20150610 |