CN102920680A - Roxithromycin capsule and preparation method thereof - Google Patents
Roxithromycin capsule and preparation method thereof Download PDFInfo
- Publication number
- CN102920680A CN102920680A CN2012104954062A CN201210495406A CN102920680A CN 102920680 A CN102920680 A CN 102920680A CN 2012104954062 A CN2012104954062 A CN 2012104954062A CN 201210495406 A CN201210495406 A CN 201210495406A CN 102920680 A CN102920680 A CN 102920680A
- Authority
- CN
- China
- Prior art keywords
- roxithromycin
- preparation
- capsules
- time
- recipe quantity
- 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.)
- Pending
Links
Abstract
The invention discloses a roxithromycin capsule and a preparation method thereof. The roxithromycin capsule consists of the following materials in percentage by weight: 60-75% of roxithromycin, 3-5% of talcum powder, 6-12% of carboxymethyl starch sodium, 15-20% of silicon dioxide, 0.1-1% of magnesium stearate and 1-2% of sodium bicarbonate. The preparation method disclosed by the invention is simple in preparation process and convenient to operate, and the content of the main medicine in the prepared roxithromycin is stable. The utilization of an anti-sticking agent and a solubilizer is reduced and the bioavailability of the medicine and the medicine adaptability of patients are enhanced.
Description
Technical field
The invention belongs to field of medicine preparations, be specifically related to a kind of roxithromycin capsules and preparation method thereof.
Background technology
Roxithromycin, English name: Roxithromycin, English another name: Claramid, Rulid are a kind of semisynthetic erythromycin derivatives, belong to Western medicine drug.At first be applied in France, and be widely applied all over the world now in 1988.Roxithromycin antimicrobial spectrum and erythromycin are close, to staphylococcus aureus (except the MRsA), streptococcus (comprises streptococcus pneumoniae and A, B, C type streptococcus, but except G type and the enterococcus), corynebacterium, Lee department is bacterium too, mucositis mora bacterium (micrococcus catarrhalis), the legionella equal altitudes is responsive or responsive, to bacteroides oralis, produce black bacteroid, dyspepsiacoccus, peptostreptococcus, anaerobe and the encephalitis toxoplasmas such as propionibacterium acnes, chlamydia, treponema pallidums etc. also have preferably antibacterial action, to pylori, gonococcus, meningococcus, a little less than the effect such as bordetella pertussis, its vitro antibacterial activity and erythromycin are similar, and vivo bacteria corrosion action is stronger 1-4 times than erythromycin.The blood peak concentration of drug of this product is the highest kind of macrolide apoplexy due to endogenous wind, is macrolide antibiotics of new generation, and Main Function is in gram positive bacteria, anaerobe, chlamydia and mycoplasma etc.For the upper and lower respiratory tract infection for the treatment of, otorhinolaryngology infection, genitals (except the gonococcal infection) and skin infection fabulous curative effect is arranged.
Roxithromycin capsules is widely used clinical in recent years.Chinese patent literature CN1180779C discloses a kind of sow-released roxithromycin capsule, and the Product Process of the method preparation is simple, and its product drug effect is obvious, is worth certainly.CN101224217B discloses a kind of skeleton type roxithromycin sustained release pellet capsule, the method is by adopting framework material to delay drug release, in the density that reduces slow-release micro-pill, prolong the holdup time of slow-release micro-pill in intestines and stomach, improved to a certain extent the bioavailability of medicine.The roxithromycin capsules that above-mentioned two kinds of methods are produced meets the requirement of suitability for industrialized production, but the pharmaceutic adjuvant of its interpolation is too much, and the safety of the stability of its drug content, medicine itself, patient's medicine compliance remain to be investigated.
Summary of the invention
The present invention aims to provide that a kind of bioavailability is high, patient's medicine compliance is good, the roxithromycin capsules of safe without toxic side effect and preparation method thereof.
For achieving the above object, a kind of roxithromycin capsules of the present invention and preparation method thereof, its specific embodiments is:
A kind of roxithromycin capsules of the present invention and preparation method thereof is characterized in that each component of the method is by weight percentage: Roxithromycin 60-75%, Pulvis Talci 3-5%, carboxymethylstach sodium 6-12%, silica 1 5-20%, magnesium stearate 0.1-1%, sodium bicarbonate 1-2%.
A kind of roxithromycin capsules of the present invention and preparation method thereof is characterized in that the method concrete steps are:
1) supplementary material is processed: the Roxithromycin raw material is by 60 mesh sieves sieve powder, and carboxymethyl starch sodium is crossed 100 mesh sieves.
2) granulate: take by weighing Roxithromycin, carboxymethyl starch sodium by recipe quantity; recipe quantity 1/2-2/3 silicon dioxide joins to be dry mixed in the wet granulator and stirs; add 50% ethanol and stir soft material processed, check soft material quality: make it hands and pinch agglomeratingly, namely faling apart of stranding is advisable.Soft material is granulated with 24 mesh sieves, drying.
3) granulate, total mixed: dried granule is with 24 mesh sieve granulate, adds remaining silicon dioxide, Pulvis Talci, magnesium stearate, sodium bicarbonate and places V-Mixer, mix homogeneously.
4) granule with preparation is filled into the Capsules of preparation by specification, carries out aluminum-plastic packaged after the Bao Pinquan inspection is qualified.
A kind of roxithromycin capsules of the present invention and preparation method thereof is characterized in that it is 5 minutes that the method wet granulation is dry mixed mixing time, and the wet mixing mixing time is 3 minutes, baking temperature 50-60 ℃, and 1-3 hour drying time.
A kind of roxithromycin capsules of the present invention and preparation method thereof is characterized in that the method is always done time to be controlled to be half an hour.
A kind of roxithromycin capsules of the present invention and preparation method thereof is characterized in that the method use 1
#Mould, 1
#Capsules, the preparation roxithromycin capsules.
A kind of roxithromycin capsules of the present invention and preparation method thereof is characterized in that the method silicon dioxide adds at twice, adds 2/3 of recipe quantity for the first time, adds 1/3 of recipe quantity for the second time.
Compared with prior art, the method for the invention has the following advantages:
1. technique of the present invention is simple, and supplementary material is easy to get, and production cost is low.
2. product main ingredient reasonable mixture ratio of the present invention, bioavailability is high, safe without toxic side effect.
3. this product drug content is stable, storage, easy to carry.
This product can be used as the prophylactic with epidemic encephalitis patient Close contacts, mainly adapts to the following infection that sensitive strain causes: 1, upper respiratory tract infection; 2, lower respiratory infection; 3, otorhinolaryngology infects; 4, genital infection (except the gonococcal infection); 5, skin soft-tissue infection; 6, mycoplasma pneumonia, chlamydia trachomatis infection and legionnaires disease etc.According to clinical trial, this product comprises the cure rate 78%～100% of mycoplasma pneumoniae pneumonia to lower respiratory infection, and bacteria clearance reaches 91%～95%.Curative effect and doxycycline to acute and chronic non gonococcal urethritis are suitable, and bacteria clearance reaches 86%～100%.Curative effect to children's Ge Ke infection and skin, soft tissue infection is similar to other Macrolidees.
The specific embodiment
Below enforcement only for more detailed description the present invention, but do not limit in any form the present invention.
Embodiment: the preparation of roxithromycin capsules
Prescription:
Roxithromycin 1500g
Pulvis Talci 82.5g
Carboxymethylstach sodium 250 g
Silicon dioxide 390 g
Magnesium stearate 24 g
Sodium bicarbonate 45 g
Make altogether 10000
Preparation method:
At first the Roxithromycin raw material is sieved powder by 60 mesh sieves, carboxymethyl starch sodium is crossed 100 mesh sieves.Take by weighing Roxithromycin, carboxymethyl starch sodium by recipe quantity again; recipe quantity 2/3 silicon dioxide joins and is dry mixed 5 minutes in the wet granulator and stirs; add 50% ethanol and stir 240 seconds soft materials processed, check soft material quality: make it hands and pinch agglomeratingly, namely faling apart of stranding is advisable.Soft material is granulated with 24 mesh sieves, about 2 hours of 50-60 ℃ of drying.Dried granule with 24 mesh sieve granulate, is added remaining silicon dioxide, Pulvis Talci, magnesium stearate, sodium bicarbonate and places V-Mixer, mix homogeneously, incorporation time is 30 minutes.By the filling instruction sheet granule is carried out capsule-filling at last.After the Bao Pinquan inspection is qualified, carry out aluminum-plastic packaged.
Claims (5)
1. roxithromycin capsules and preparation method thereof is characterized in that each component of the method is by weight percentage: Roxithromycin 60-75%, Pulvis Talci 3-5%, carboxymethylstach sodium 6-12%, silica 1 5-20%, magnesium stearate 0.1-1%, sodium bicarbonate 1-2%, its preparation process is:
1) supplementary material is processed: the Roxithromycin raw material is by 60 mesh sieves sieve powder, and carboxymethyl starch sodium is crossed 100 mesh sieves;
2) granulate: take by weighing Roxithromycin, carboxymethyl starch sodium by recipe quantity, recipe quantity 1/2-2/3 silicon dioxide joins to be dry mixed in the wet granulator and stirs, and adds 50% ethanol stirring soft material processed, and soft material is granulated with 24 mesh sieves, drying;
3) granulate, total mixed: dried granule is with 24 mesh sieve granulate, adds remaining silicon dioxide, Pulvis Talci, magnesium stearate, sodium bicarbonate and places V-Mixer, mix homogeneously;
4) granule with preparation is filled into the Capsules of preparation by specification, carries out aluminum-plastic packaged after the Bao Pinquan inspection is qualified.
2. ask 1 described method according to right, it is characterized in that it is 5 minutes that the method wet granulation is dry mixed mixing time, the wet mixing mixing time is 3 minutes, baking temperature 50-60 ℃, and 1-3 hour drying time.
3. described method according to claim 1 is characterized in that the method is always done time to be controlled to be half an hour.
4. described method according to claim 1 is characterized in that the method uses 1 when filling
#Mould, 1
#Capsules prepares roxithromycin capsules.
5. according to described method according to claim 1, it is characterized in that the method silicon dioxide adds at twice, add 2/3 of recipe quantity for the first time, add 1/3 of recipe quantity for the second time.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2012104954062A CN102920680A (en) | 2012-11-29 | 2012-11-29 | Roxithromycin capsule and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2012104954062A CN102920680A (en) | 2012-11-29 | 2012-11-29 | Roxithromycin capsule and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN102920680A true CN102920680A (en) | 2013-02-13 |
Family
ID=47635708
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2012104954062A Pending CN102920680A (en) | 2012-11-29 | 2012-11-29 | Roxithromycin capsule and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN102920680A (en) |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105997929A (en) * | 2016-06-23 | 2016-10-12 | 南京华宽信息咨询中心 | Roxithromycin capsule and preparation method thereof |
| CN107638419A (en) * | 2017-06-26 | 2018-01-30 | 安徽永生堂药业有限责任公司 | A kind of roxithromycin capsules and preparation method thereof |
| CN109758433A (en) * | 2019-02-14 | 2019-05-17 | 武汉同济现代医药科技股份有限公司 | A kind of Roxithromycin Capsules and preparation method thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2003099197A2 (en) * | 2002-05-28 | 2003-12-04 | J.B. Chemicals & Pharmaceuticals Ltd. | Formulations of erythromycin derivatives with improved bioavailability |
| CN101664395A (en) * | 2008-09-03 | 2010-03-10 | 山东淄博新达制药有限公司 | Method for producing roxithromycin capsules |
-
2012
- 2012-11-29 CN CN2012104954062A patent/CN102920680A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2003099197A2 (en) * | 2002-05-28 | 2003-12-04 | J.B. Chemicals & Pharmaceuticals Ltd. | Formulations of erythromycin derivatives with improved bioavailability |
| CN101664395A (en) * | 2008-09-03 | 2010-03-10 | 山东淄博新达制药有限公司 | Method for producing roxithromycin capsules |
Non-Patent Citations (1)
| Title |
|---|
| 李国章: "浅析一种罗红霉素胶囊制备工艺的优化方案", 《求医问药（下半月刊）》 * |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105997929A (en) * | 2016-06-23 | 2016-10-12 | 南京华宽信息咨询中心 | Roxithromycin capsule and preparation method thereof |
| CN107638419A (en) * | 2017-06-26 | 2018-01-30 | 安徽永生堂药业有限责任公司 | A kind of roxithromycin capsules and preparation method thereof |
| CN109758433A (en) * | 2019-02-14 | 2019-05-17 | 武汉同济现代医药科技股份有限公司 | A kind of Roxithromycin Capsules and preparation method thereof |
| CN109758433B (en) * | 2019-02-14 | 2020-12-15 | 武汉同济现代医药科技股份有限公司 | Roxithromycin capsule and preparation method thereof |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| WO2020113811A1 (en) | Biopolymer nanosphere containing nicotinamide mononucleotide, preparation method therefor and use thereof | |
| CN102920680A (en) | Roxithromycin capsule and preparation method thereof | |
| JP2005515212A (en) | Wet granulation method of azithromycin | |
| CN101904813A (en) | Freeze-dried coated mechanograph | |
| CN106580887A (en) | Marbofloxacin soluble pulvis | |
| CN101607086B (en) | Compound bismuth composition and preparation method thereof | |
| CN103156814B (en) | A kind of Azithromycin enteric composition and preparation method | |
| CN103610658A (en) | Immunomodulator slow-release preparation and preparation method thereof | |
| CN106822097B (en) | Orlistat-containing pharmaceutical composition for losing weight | |
| CN103263395A (en) | Telmisartan tablet preparation and preparation method thereof | |
| CN102525878A (en) | Tranexamic acid sustained-release solid composition and preparation method thereof | |
| CN102358749B (en) | Roxithromycin ambroxol tablet composite and preparing method thereof | |
| CN104173310A (en) | Stable amoxicillin tablet composition, as well as preparation method and application thereof | |
| CN100500161C (en) | Azithromycin micro-pill capsule and its preparing method | |
| CN102935232A (en) | Production and application methods of magnesium-stearate-containing medicinal premix auxiliary material used in direct tableting or capsule filling | |
| CN103040787A (en) | Azithromycin capsule and preparation method thereof | |
| CN102058611A (en) | Compound solid preparation for treating asthma | |
| CN101278918A (en) | Azithromycin sustained release tablets and method of preparing the same | |
| CN105193760A (en) | High-content glucosamine sulfate tablet and preparation method | |
| CN102058587A (en) | Solid preparation for treating asthma | |
| CN113747886A (en) | Novel specific water-soluble vitamin delivery system | |
| CN101249080A (en) | Acetylkitasamycin dispersible tablet and method of preparing the same | |
| CN103462922B (en) | A kind of levetiracetam sustained-release tablets and method for making thereof | |
| CN106310222A (en) | Colistin sulfate and berberine hydrochloride composition and preparation method of pellets of colistin sulfate and berberine hydrochloride composition | |
| CN101926782B (en) | Oral solid drug compound containing dienogest |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| RJ01 | Rejection of invention patent application after publication | ||
| RJ01 | Rejection of invention patent application after publication |
Application publication date: 20130213 |