CN103263399A - Cefradine capsules and preparation method thereof - Google Patents
Cefradine capsules and preparation method thereof Download PDFInfo
- Publication number
- CN103263399A CN103263399A CN201310225189XA CN201310225189A CN103263399A CN 103263399 A CN103263399 A CN 103263399A CN 201310225189X A CN201310225189X A CN 201310225189XA CN 201310225189 A CN201310225189 A CN 201310225189A CN 103263399 A CN103263399 A CN 103263399A
- Authority
- CN
- China
- Prior art keywords
- cefradine
- capsule
- preparation
- span
- fine powder
- 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.)
- Granted
Links
Classifications
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention discloses cefradine capsules and a preparation method thereof. The capsules consist of filler and capsule shells, wherein the filler is obtained by mixing medicament-containing fine powder and a lubricating agent uniformly, and the medicament-containing fine powder is prepared from cefradine, Span and neutral inorganic salt. The preparation method comprises the following steps of: adding the cefradine into the Span, stirring uniformly, then adding the inorganic salt, performing adsorption to obtain the medicament-containing fine powder, mixing the medicament-containing fine powder and the lubricating agent, and filling the capsule shells with the mixture. The capsules have the advantages of high stability and quick dissolution, meanwhile, the preparation method is simple and meets the requirement of mass production.
Description
Technical field
The invention belongs to medical technical field, be specifically related to a kind of cefradine capsule and preparation method thereof.
Background technology
Cefradine (Cephradine, Velosef) another name cephradine, cefradine etc. are the semi-synthetic cephalosporin of the first generation, antibacterial action is similar to cefalexin.This product is acidproof can be oral, good absorbing, and blood drug level is higher, characteristics are anti-beta lactamases, the multiple bacillus to the broad ectrum antibiotic drug resistance of drug resistance gold Portugal bacterium and other etc. is had bactericidal action rapidly and reliably, mainly with original shape through homaluria, concentration is higher in the urine.The clinical infection that is mainly used in respiratory tract, urinary tract, skin and soft tissue etc., as bronchitis, pneumonia, pyelonephritis, cystitis, ear,nose ﹠ throat infection, enteritis and dysentery etc.
Yet, because cefradine is beta-lactam enzyme antibiotic, unstable chemcial property, hydrolysis easily seriously influences product quality, has influence on drug safety even.At present, the listing preparation requires to preserve in cool dark place, to guarantee preparation stability, does not fundamentally solve the problem of cefradine facile hydrolysis.
Summary of the invention
At the deficiencies in the prior art, the inventor intends fundamentally solving the problem of cefradine facile hydrolysis.The inventor considers if block contacting of cefradine and extraneous water, will increase substantially the stability of cefradine, thereby high cefradine capsule of a kind of stability and preparation method thereof is provided.
In order to realize the foregoing invention purpose, the inventor has finally obtained following technical scheme by a large amount of experimental studies:
A kind of cefradine capsule is made up of implant and capsule shells, and wherein said implant is with pastille fine powder and lubricant mixing and get, and described pastille fine powder is prepared from by cefradine, span and neutral inorganic.
Preferably, above-mentioned cefradine capsule, wherein said pastille fine powder are cefradine to be added in the span stir evenly, and add inorganic salt absorption then and form.
Preferably, above-mentioned cefradine capsule, wherein said neutral inorganic is one or more in calcium sulfate, calcium carbonate and the calcium hydrogen phosphate.
Further preferably, above-mentioned cefradine capsule, wherein said neutral inorganic is selected from calcium sulfate.
Preferably, above-mentioned cefradine capsule, wherein the weight ratio of cefradine, span, neutral inorganic is 1:0.5-1.5:0.8-2.
Again further preferably, above-mentioned cefradine capsule, wherein said span are that sorbester p17 is or/and sorbester p37.
Again further preferably, above-mentioned cefradine capsule, wherein said lubricant are that Pulvis Talci is or/and micropowder silica gel.
The inventor creatively is dispersed in cefradine in the span, because span is hydrophobic surfactant, forms one deck oil film on the medicine top layer, has blocked the influence of moisture to cefradine; Then with inert material neutral inorganic absorption oil phase, because it is neutral substance, do not have draw moist, at last with this mixture and mix lubricant, capsule charge, namely.
Therefore, second purpose of the present invention is to provide a kind of preparation method of above-mentioned arbitrary cefradine capsule, this preparation method comprises the steps: cefradine is sieved, join in the span, stir, add then inorganic salt adsorb the pastille fine powder, at last with pastille fine powder and mix lubricant, the capsule charge shell.
Preferably, the preparation method of above-mentioned cefradine capsule, wherein said span is that sorbester p17 is or/and sorbester p37.
Preferably, the preparation method of above-mentioned cefradine capsule, wherein said lubricant is that Pulvis Talci is or/and micropowder silica gel.
The present invention selects contacting of hydrophobic surfactant span blocking drugs and water for use, simultaneously, although span is water insoluble, can disperse in water, can not influence the medicine stripping; Select the inorganic salt absorption oil phase of high adsorption capacity in addition for use, inorganic salt such as calcium sulfate, calcium hydrogen phosphate, calcium carbonate dissolubility in hydrochloric acid is good, and when carrying out dissolution determination, inorganic salt dissolves fast, helps medicine to be dispersed in rapidly in the dissolution medium, stripping fast.Experimental studies have found that by accelerating experiment and dissolution determination the cefradine capsule of the present invention's preparation has good stability, stripping advantage rapidly, preparation technology is simple simultaneously, is fit to big production requirement.
The specific embodiment
Following examples further describe preparation process of the present invention and beneficial effect, embodiment only is used for the purpose of illustration, do not limit the scope of the invention, apparent change and modification that while those of ordinary skills make according to the present invention are also contained within the scope of the invention.
The preparation of embodiment 1 cefradine capsule
Preparation technology
Cefradine is crossed 100 mesh sieves, joins in the sorbester p17 of recipe quantity, stirs, and adds the calcium hydrogen phosphate absorption of 80 mesh sieves, mixes capsule charge with micropowder silica gel at last.
The preparation of embodiment 2 cefradine capsules
Preparation technology
Cefradine is crossed 120 mesh sieves, joins in the sorbester p37 of recipe quantity, stirs, and adds calcium hydrogen phosphate and the titanium pillaring solution of 80 mesh sieves, mixes capsule charge with Pulvis Talci at last.
The preparation of embodiment 3 cefradine capsules
Preparation technology
Cefradine is crossed 100 mesh sieves, joins in the sorbester p17 of recipe quantity, stirs, and adds the calcium sulfate absorption of 80 mesh sieves, mixes capsule charge with micropowder silica gel at last.
The preparation of comparative example's 1 cefradine capsule
Cefradine 125g
Calcium sulfate 200g
Micropowder silica gel 5g
Preparation technology
Cefradine is crossed 100 mesh sieves, adds the calcium sulfate mix homogeneously of 80 mesh sieves, mixes capsule charge then with micropowder silica gel.
Dissolution and the stability study of embodiment 4 cefradine capsules
1. dissolution.The cefradine capsule sample of each embodiment preparation is got in sampling, according to dissolution method (appendix XC first method), be dissolution medium with 0.lmol/L hydrochloric acid solution 900ml, rotating speed is that per minute 100 changes, operation in accordance with the law, in the time of 15 minutes, it is an amount of to get solution, filters, it is an amount of that precision is measured subsequent filtrate, make the solution that contains 25 μ g among every lml approximately with the quantitative dilution of dissolution medium, according to ultraviolet visible spectrophotometry (appendix IV A), measure absorbance at the wavelength place of 255nm; Other gets the content under the content uniformity item, mix homogeneously, and precision takes by weighing in right amount (being equivalent to average loading amount), by labelled amount add the stripping medium dissolves and quantitatively dilution make the solution that contains 25 μ g among every lml, filter, get subsequent filtrate, measure with method, calculate every stripping quantity.Limit is 80%, should be up to specification.
2. related substance.Get the content under the content uniformity item, mix and all to collude, precision takes by weighing in right amount, adds the mobile phase dissolving and quantitatively dilutes and make the solution that contains cefradine lmg among every lml, as need testing solution.Measure according to the method under the cefradine item, the detection wavelength is 254nm.In the need testing solution chromatogram if any impurity peaks, each impurity peak area and must not be greater than 2 times (1.0%) of contrast solution main peak area.
Table 1 embodiment measurement result
From the experimental result of table 1 as can be seen: the cefradine capsule stability of embodiment of the invention 1-3 preparation is good, accelerates only increase slightly again of related substance after 6 months, and stripping is rapid, the complete stripping of 15min; Comparative example 1 does not prepare capsule filling with span as oil phase, and the related substance of preparation increases obviously.
Claims (10)
1. a cefradine capsule is made up of implant and capsule shells, it is characterized in that: described implant is with pastille fine powder and lubricant mixing and get, and described pastille fine powder is prepared from by cefradine, span and neutral inorganic.
2. cefradine capsule according to claim 1, it is characterized in that: described pastille fine powder is cefradine to be added in the span stir evenly, and adds inorganic salt absorption then and forms.
3. cefradine capsule according to claim 1, it is characterized in that: described neutral inorganic is one or more in calcium sulfate, calcium carbonate and the calcium hydrogen phosphate.
4. cefradine capsule according to claim 3, it is characterized in that: described neutral inorganic is calcium sulfate.
5. cefradine capsule according to claim 1, it is characterized in that: the weight ratio of cefradine, span, neutral inorganic is 1:0.5-1.5:0.8-2.
6. according to each described cefradine capsule of claim 1-5, it is characterized in that: described span is that sorbester p17 is or/and sorbester p37.
7. according to each described cefradine capsule of claim 1-5, it is characterized in that: described lubricant is that Pulvis Talci is or/and micropowder silica gel.
8. preparation method according to each described cefradine capsule of claim 1-5, it is characterized in that comprising the steps: cefradine is sieved, join in the span, stir, add then inorganic salt adsorb the pastille fine powder, at last with pastille fine powder and mix lubricant, the capsule charge shell.
9. the preparation method of cefradine capsule according to claim 8, it is characterized in that: described span is that sorbester p17 is or/and sorbester p37.
10. the preparation method of cefradine capsule according to claim 8, it is characterized in that: described lubricant is that Pulvis Talci is or/and micropowder silica gel.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310225189.XA CN103263399B (en) | 2013-06-06 | 2013-06-06 | Cefradine capsules and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310225189.XA CN103263399B (en) | 2013-06-06 | 2013-06-06 | Cefradine capsules and preparation method thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN103263399A true CN103263399A (en) | 2013-08-28 |
| CN103263399B CN103263399B (en) | 2015-07-22 |
Family
ID=49007097
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201310225189.XA Active CN103263399B (en) | 2013-06-06 | 2013-06-06 | Cefradine capsules and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN103263399B (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103462928A (en) * | 2013-09-04 | 2013-12-25 | 南京正亮医药科技有限公司 | Cefalexin capsules and preparation method thereof |
| CN104688712A (en) * | 2015-03-19 | 2015-06-10 | 南京多宝生物科技有限公司 | Cefradine capsule |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1586486A (en) * | 2004-07-12 | 2005-03-02 | 北京瑞伊人科技发展有限公司 | Cefpodoxime proxetil soft capsule preparation and its preparing method |
| CN101843599A (en) * | 2009-03-23 | 2010-09-29 | 杭州锐思医药科技有限公司 | Oral cephalosporin ester capsule |
| CN102335159A (en) * | 2011-09-30 | 2012-02-01 | 深圳市国源药业有限公司 | Cefetamet pivoxil hydrochloride capsule and preparation method thereof |
-
2013
- 2013-06-06 CN CN201310225189.XA patent/CN103263399B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1586486A (en) * | 2004-07-12 | 2005-03-02 | 北京瑞伊人科技发展有限公司 | Cefpodoxime proxetil soft capsule preparation and its preparing method |
| CN101843599A (en) * | 2009-03-23 | 2010-09-29 | 杭州锐思医药科技有限公司 | Oral cephalosporin ester capsule |
| CN102335159A (en) * | 2011-09-30 | 2012-02-01 | 深圳市国源药业有限公司 | Cefetamet pivoxil hydrochloride capsule and preparation method thereof |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103462928A (en) * | 2013-09-04 | 2013-12-25 | 南京正亮医药科技有限公司 | Cefalexin capsules and preparation method thereof |
| CN104688712A (en) * | 2015-03-19 | 2015-06-10 | 南京多宝生物科技有限公司 | Cefradine capsule |
Also Published As
| Publication number | Publication date |
|---|---|
| CN103263399B (en) | 2015-07-22 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| Mooranian et al. | Release and swelling studies of an innovative antidiabetic-bile acid microencapsulated formulation, as a novel targeted therapy for diabetes treatment | |
| CN101856356B (en) | Cefazedone sodium composition powder injection | |
| CN103263399B (en) | Cefradine capsules and preparation method thereof | |
| CN102895215A (en) | Cellulose and red alga polysaccharide plant empty capsule and raw material composition and preparation method thereof | |
| CN103462928A (en) | Cefalexin capsules and preparation method thereof | |
| CN109432092B (en) | A kind of lactation period compound antibacterial preparation and its preparation method and application | |
| CN100370984C (en) | Telmisartan dispersible tablet and its preparation method | |
| CN103919744B (en) | A kind of Cefteram Pivoxil Tablets and preparation technology thereof | |
| CN100415230C (en) | Dispersion tablets of penicillin V potassium, and its preparing method | |
| CN105476954B (en) | A kind of lomefloxacin hydrochloride injection and preparation method | |
| CN106265505B (en) | A kind of amoxicillin and clavulanate potassium oil suspension and preparation method thereof | |
| CN104000774A (en) | Tannin paste and preparation method | |
| CN108159002B (en) | A kind of preparation method of onion biomimetic multilayer structure controllable drug release carrier | |
| CN104688712A (en) | Cefradine capsule | |
| Morais et al. | Comparative study on the influence of the content and functionalization of alginate matrices on K-562 cell viability and differentiation | |
| CN103432076A (en) | Cefprozil dry suspension and preparation method thereof | |
| CN109646392A (en) | A kind of gelling agent and its preparation process containing clindamycin phosphate | |
| CN110448538B (en) | N-acetylglucosamine capsule preparation and preparation method thereof | |
| CN104644601B (en) | Capecitabine tablet | |
| CN104188914B (en) | Amoxicillin powder and its production technology | |
| CN101642432A (en) | Latamoxef sodium proliposome preparation | |
| CN113081988B (en) | Cefradine dispersible tablet and preparation method thereof | |
| CN102600143B (en) | Vinpocetine medicament composition and preparation method thereof | |
| CN102895175B (en) | Prulifloxacin oral solid composition and preparation method thereof | |
| CN103417535B (en) | A kind of amoxicillin and clavulanate potassium tablets and preparation method thereof |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| C41 | Transfer of patent application or patent right or utility model | ||
| TR01 | Transfer of patent right |
Effective date of registration: 20161207 Address after: 200000 Shanghai Road, Fengxian District, No. 54, No. 1388 Patentee after: Shanghai Meiu Pharmaceutical Co., Ltd. Address before: Qingfeng District of Lishui District of Nanjing City, Jiangsu province 211200 Yong Yang Town Green Village building 22 Room 301 Patentee before: Nanjing Zhengkuan Pharmaceutical Science and Technology Co., Ltd. |