CN1180779C - Sow-released roxithromycin capsule and method for preparing same - Google Patents
Sow-released roxithromycin capsule and method for preparing same Download PDFInfo
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- CN1180779C CN1180779C CNB021174857A CN02117485A CN1180779C CN 1180779 C CN1180779 C CN 1180779C CN B021174857 A CNB021174857 A CN B021174857A CN 02117485 A CN02117485 A CN 02117485A CN 1180779 C CN1180779 C CN 1180779C
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- roxithromycin
- capsule
- sealing coat
- sodium lauryl
- lauryl sulphate
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Abstract
The present invention relates to a slow release roxithromycin capsule which is an antibiotic and a preparation method thereof. The contents of the capsule are mini-pills (pellets), and each of the mini-pills (pellets) comprises a medicine pill core and an isolation layer. The capsule is a slow release dosage form, reduces the times of taking the medicine every day, and lightens patient's pain. Compared with the ordinary roxithromycin preparation, the slow release roxithromycin capsule of the present invention has the obvious characteristics of safety, effectiveness, low toxicity, preparation with a conventional process, and easy realization and industrialization production.
Description
Invention field
The present invention relates to a kind of slow releasing preparation and preparation thereof of antibacterials Roxithromycin.
Background of invention
The invention discloses slow releasing capsule of a kind of roxithromycin sustained release preparation, particularly Roxithromycin and preparation method thereof.Roxithromycin is the semi-synthetic derivant behind the erythromycin structure of modification, its chemistry 9-[0-(2-methoxy ethoxy) by name-methyl] oxime] erythromycin, its mechanism of action and antimicrobial spectrum are similar with erythromycin, and be slightly poor than erythromycin to the gram positive bacteria effect, strong than erythromycin to the legionella pneumophilia effect.To the anti-microbial effect of Chlamydia pneumoniae, mycoplasma pneumoniae, molten urea urea substance and erythromycin is similar or slightly strong.Roxithromycin has better chemical stability, and it is wide to distribute in tissue, and particularly the concentration in lung tissue is higher.
Slow releasing preparation is a kind of new medicinal preparation technology that development in recent years is got up.Roxithromycin is made slow releasing capsule medicining times is limited in once a day, medicine blood drug level is mild, and it is little to fluctuate, and reduces untoward reaction.Antibiotics class medicine divides three types: first kind is waviness dependent form, and promptly its bactericidal potency improves along with the increase of concentration; Second kind is time-dependent, promptly reach a certain concentration when above at medicine, its bactericidal potency is directly proportional with medicine and antibacterial time of contact, i.e. time long germicidal efficiency height more more, and the third does not have obvious concentration dependent form feature for both there being obvious time-dependent feature yet.Roxithromycin belongs to second type; So make slow release formulation and help keeping higher bacteriocidal concentration, thereby improve bactericidal potency.
Goal of the invention
One of purpose of the present invention provides a kind of sow-released roxithromycin capsule that can keep strong bacteriocidal concentration in a long time.
Two of purpose of the present invention provides a kind of preparation method of sow-released roxithromycin capsule.
Three of purpose of the present invention is by Roxithromycin being made the side effect that slow release formulation reduces Roxithromycin.
Summary of the invention
Sow-released roxithromycin capsule of the present invention prepares by the following method.Earlier Roxithromycin is made slow-release micro-pill (piller).The preparation method of this micropill (piller) has powder lamination method, suspension medicine-feeding method or wet pill method etc., and the equipment that is adopted can be centrifugal pan coating comminutor; fluidized-bed coating machine is extruded spheronizator etc., makes slow-release micro-pill; after wrapping one deck sealing coat then, reinstall capsule by specification.
Sow-released roxithromycin capsule of the present invention, medicine ball core wherein comprises Roxithromycin, a kind of binding agent, a kind of filler, a kind of water-soluble lubricant.Sealing coat composition wherein comprises: a kind of antitack agent, a kind of water solublity porogen, a kind of antistatic additive; A kind of non-PH dependency hangs down permeable polymers.
Sow-released roxithromycin capsule of the present invention, medicine ball core wherein is to spray medicine layer at its skin on the basis of blank pill nuclear, or principal agent thing and adjuvant be mixed and made into the ball core, blank pill nuclear composition comprises microcrystalline Cellulose, methacrylate polymer or ethyl cellulose.Binding agent in the ball core is a hydroxypropyl methylcellulose, and filler is microcrystalline Cellulose, Icing Sugar, and lubricant is a sodium lauryl sulphate.Sow-released roxithromycin capsule of the present invention, antitack agent is a Pulvis Talci in the sealing coat; The water solublity porogen is a Polyethylene Glycol, and antistatic additive is a sodium lauryl sulphate, and the low permeable polymers of non-PH dependency is methacrylate copolymer or ethyl cellulose.
Sow-released roxithromycin capsule of the present invention, diameter by the Roxithromycin that contains 100-500mg is formed at the ball-type slow releasing pharmaceutical micropill of 0.5-10mm, slow-release micro-pill wherein is made up of medicine ball core and sealing coat, consisting of of medicine ball core: Roxithromycin, a kind of binding agent, a kind of filler, a kind of water-soluble lubricant, consisting of of sealing coat: a kind of antitack agent, a kind of water solublity porogen, a kind of antistatic additive and a kind of non-pH value dependency hang down permeable polymers, and the binding agent in the medicine ball core is a hydroxypropyl methylcellulose, filler is a microcrystalline Cellulose, Icing Sugar, lubricant is a sodium lauryl sulphate, and antitack agent is a Pulvis Talci in the sealing coat, and the water solublity porogen is a Polyethylene Glycol, antistatic additive is a sodium lauryl sulphate, and the low permeable polymers of non-PH dependency is methacrylate copolymer or ethyl cellulose.
Sow-released roxithromycin capsule of the present invention is micropill (piller) capsule, preferred composition mode is: the ball core is made up of following composition: Roxithromycin (100mg-500mg), microcrystalline Cellulose (100mg-200mg), Icing Sugar (40mg-150mg) are diluent, sodium lauryl sulphate (0.1mg-1.5mg), also can add an amount of hydroxypropyl methylcellulose as binding agent, wherein Icing Sugar is a diluent, and sodium lauryl sulphate is a surfactant.The sealing coat coating fluid prescription is: it is the low permeable polymers that non-pH relies on that the plain ball of every 500g uses methacrylic acid copolymer or ethyl cellulose (10-100g) copolymer wherein, and Pulvis Talci (6g-90g) is as antiplastering aid; Polyethylene glycol 6000 (0.2g-3.0g) is a porogen; Sodium lauryl sulphate (0.1g-0.8g) is an antistatic additive.
The present invention is further illustrated by the following examples.
Embodiment
Embodiment one:
(1) preparation of parent nucleus (hollow micropellets)
Preparation: can adopt commercially available blank micropill, also can adopt centrifugal coating pelletizing machine, High Speed Stirring Machine, extrude the preparation of spheronizator or fluidised bed granulator.
(2) contain the pill core prescription:
Roxithromycin 300g
Microcrystalline Cellulose 70g
Icing Sugar 40g
5% hydroxypropyl methylcellulose is an amount of
Sodium lauryl sulphate 0.3g
Make 1000
(3) coating 500g pastille micropill consumption
Coating fluid prescription:
Methacrylic acid copolymer 27%
Or ethyl cellulose 35%
Pulvis Talci 28.0g
Polyethylene glycol 6000 0.85g
Sodium lauryl sulphate 0.21g
Water 107ml
Dosing: get recipe quantity methacrylic acid copolymer or ethyl cellulose, Pulvis Talci (1250 order), sodium lauryl sulphate, Polyethylene Glycol and water or ethanol mix and stir the back as coating solution.
Preparation: get 18-24 order pastille micropill 500g, put centrifugal coating pelletizing machine or fluidized bed granulation coating machine carries out coating.Above-mentioned pastille coated micropill is filled conventional capsule promptly in accordance with regulations.
Through investigating, sow-released roxithromycin capsule release in vitro degree of the present invention is: 2 hours are less than 30%, 6 hour is 40-80%, and 10 hours greater than 75%.
Claims (2)
1. sow-released roxithromycin capsule, it is characterized in that, this slow releasing capsule is made up of at the ball-type slow releasing pharmaceutical micropill of 0.5-10mm the diameter of the Roxithromycin that contains 100-500mg, slow-release micro-pill wherein is made up of medicine ball core and sealing coat, consisting of of medicine ball core: Roxithromycin, a kind of binding agent, a kind of filler, a kind of water-soluble lubricant, consisting of of sealing coat: a kind of antitack agent, a kind of water solublity porogen, a kind of antistatic additive and a kind of non-pH value dependency hang down permeable polymers, binding agent in the medicine ball core is a hydroxypropyl methylcellulose, and filler is a microcrystalline Cellulose, Icing Sugar, lubricant are sodium lauryl sulphate, antitack agent is a Pulvis Talci in the sealing coat, the water solublity porogen is a Polyethylene Glycol, and antistatic additive is a sodium lauryl sulphate, and the low permeable polymers of non-PH dependency is methacrylate copolymer or ethyl cellulose.
2. the sow-released roxithromycin capsule of claim 1, its Chinese medicine ball core and sealing coat composed as follows:
Contain pill core:
Roxithromycin 100mg-500mg
Microcrystalline Cellulose 100mg-200mg
Icing Sugar 40mg-150mg
Sodium lauryl sulphate 0.1mg-1.5mg
Sealing coat:
Every 500g contains pill core, and insolated layer materials is as follows:
Methacrylate copolymer or ethyl cellulose 10g-100g
Pulvis Talci 6g-90g
Polyethylene glycol 6000 0.2g-3.0g
Sodium lauryl sulphate 0.1g-0.8g.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB021174857A CN1180779C (en) | 2002-05-20 | 2002-05-20 | Sow-released roxithromycin capsule and method for preparing same |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB021174857A CN1180779C (en) | 2002-05-20 | 2002-05-20 | Sow-released roxithromycin capsule and method for preparing same |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1385164A CN1385164A (en) | 2002-12-18 |
| CN1180779C true CN1180779C (en) | 2004-12-22 |
Family
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB021174857A Expired - Fee Related CN1180779C (en) | 2002-05-20 | 2002-05-20 | Sow-released roxithromycin capsule and method for preparing same |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1180779C (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102266309A (en) * | 2011-07-12 | 2011-12-07 | 江苏黄河药业股份有限公司 | Novel roxithromycin capsule and preparation method thereof |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101224217B (en) * | 2008-01-03 | 2011-09-21 | 西安德天药业股份有限公司 | Skeleton type roxithromycin sustained release pellet capsule |
| CN106580903B (en) * | 2016-11-17 | 2019-12-13 | 江苏豪森药业集团有限公司 | Roxithromycin sustained-release pharmaceutical composition |
-
2002
- 2002-05-20 CN CNB021174857A patent/CN1180779C/en not_active Expired - Fee Related
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102266309A (en) * | 2011-07-12 | 2011-12-07 | 江苏黄河药业股份有限公司 | Novel roxithromycin capsule and preparation method thereof |
Also Published As
| Publication number | Publication date |
|---|---|
| CN1385164A (en) | 2002-12-18 |
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| CF01 | Termination of patent right due to non-payment of annual fee |
Granted publication date: 20041222 Termination date: 20110520 |