CN101524333B - Amoxicillin dispersible tablet and production method thereof - Google Patents
Amoxicillin dispersible tablet and production method thereof Download PDFInfo
- Publication number
- CN101524333B CN101524333B CN2008101013323A CN200810101332A CN101524333B CN 101524333 B CN101524333 B CN 101524333B CN 2008101013323 A CN2008101013323 A CN 2008101013323A CN 200810101332 A CN200810101332 A CN 200810101332A CN 101524333 B CN101524333 B CN 101524333B
- Authority
- CN
- China
- Prior art keywords
- amoxicillin
- dispersible tablet
- pharmaceutical carrier
- micro
- crospolyvinylpyrrolidone
- 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.)
- Active
Links
Images
Landscapes
- Medicinal Preparation (AREA)
Abstract
The invention discloses a novel formulation of amoxicillin, and in particular relates to an amoxicillin dispersible tablet and a production method thereof. The production method adopts powder direct compression technology. The amoxicillin dispersible tablet consists of amoxicillin raw medicament and a drug carrier, wherein the drug carrier comprises a diluting agent, a disintegrant and a lubricant, and selectively comprises a sweetening agent and an aromatizer; and the weight ratio of the amoxicillin raw medicament to the drug carrier is 2:1-4:1.
Description
Technical field
The present invention relates to a kind of novel form of amoxicillin, concrete, the present invention relates to a kind of amoxicillin dispersible tablet and production method thereof, described production method adopts the direct powder compression technology.
Background technology
The amoxicillin is a kind of broad spectrum antimicrobicide, is one of present most widely used antimicrobial drug.
Amoxicillin dispersible tablet is a kind of oral formulations preferably, has to absorb the advantage fast, that bioavailability is high, and taking convenience, both can be directly oral, swallow after also can adding aqueous dispersion, and also can chew or buccal.But amoxicillin dispersible tablet in the market is that what to adopt is traditional production method mostly, promptly at first through granulating, more dried granule is pressed into tablet (referring to accompanying drawing 2), and technological process is long, and the adjuvant use amount is big, also so strengthened production cost.
Because the amoxicillin is a kind of to damp and hot highstrung medicine, and traditional production method need be to pharmaceutical raw material through preparation soft material and repeatedly exsiccant process, therefore not only there is the technological process complicated problems in traditional production method, and product quality and quality of stability thereof are also had great influence.
The direct powder compression technology is that development in recent years is a new technique, be characterized in: technological process is simple, only need batch mixing and tabletting step, but this technology is to particle size distribution, particle shape, bulk density, flowability, filling, compressibility, the stability of powder body, have higher requirements all.
Because flowability, dissolubility and the compressibility of the former powder in amoxicillin are all relatively poor, therefore, adopt the direct powder compression technology to produce amoxicillin dispersible tablet and need further investigate the adjuvant that this tablet uses.
For this reason, the applicant has carried out number of research projects, character to raw material and adjuvant is researched and analysed, finally found out with material density, granularity is close and have good compressibility, mobile adjuvant, and determine its usage ratio, thereby the compound powder that obtains after the former powder in amoxicillin and this adjuvant are mixed can meet the technological requirement of direct compression.Compressibility, good fluidity that the partition of amoxicillin dispersible tablet agent of the present invention is formed shorten production procedure greatly, and yield rate improves, and be corresponding, can reduce production costs greatly, also improved product quality stability simultaneously, thereby finished the present invention.
Summary of the invention
The purpose of this invention is to provide a kind of amoxicillin dispersible tablet, this dispersible tablet is made up of former medicine in amoxicillin and pharmaceutical carrier, described pharmaceutical carrier comprises diluent, disintegrating agent and lubricant, and optionally contain sweeting agent and/aromatic, wherein the weight ratio of former medicine in amoxicillin and pharmaceutical carrier is 2-4: 1.
Concrete, in dispersible tablet of the present invention, diluent in the used pharmaceutical carrier is a micro-crystalline lactose, and disintegrating agent is selected from crospolyvinylpyrrolidone (PVPP), low-substituted hydroxypropyl cellulose and carboxymethyl cellulose, and lubricant is selected from magnesium stearate and micropowder silica gel.
Because flowability, dissolubility and the compressibility of the former powder in amoxicillin are all relatively poor, must select suitable adjuvant to improve its character.Micro-crystalline lactose is a kind of complex that microcrystalline Cellulose and spray-dired lactose premix form, it is a kind of compound pharmaceutic adjuvant, be adjuvant commonly used in the dispersible tablet preparation, flowability, dissolubility and the compressibility of the former powder in amoxicillin are greatly improved.
Preferably, pharmaceutical carrier diluent used in the dispersible tablet is a micro-crystalline lactose, and disintegrating agent is a crospolyvinylpyrrolidone, and lubricant is magnesium stearate, and wherein the weight ratio of former medicine in amoxicillin and pharmaceutical carrier is 3: 1.
The use amount of used pharmaceutical carrier in the amoxicillin dispersible tablet of the present invention, gross weight in micro-crystalline lactose, crospolyvinylpyrrolidone and three kinds of adjuvant of magnesium stearate, three's percetage by weight is respectively micro-crystalline lactose 60-94%, crospolyvinylpyrrolidone 5-30%, and magnesium stearate 1-20%; Preferably, the optimum ratio of three kinds of adjuvant is: micro-crystalline lactose 75-85%, crospolyvinylpyrrolidone 10-20%, and magnesium stearate 1-5%; Preferred, the proportioning of three kinds of adjuvant is: micro-crystalline lactose 82%, crospolyvinylpyrrolidone 15%, and magnesium stearate 3%.
In amoxicillin dispersible tablet of the present invention, can also contain sweeting agent and/or aromatic, its use amount can be determined according to the general knowledge of this area, is as the criterion to reach the taste that is fit to most patient.Preferably, described sweeting agent is a cyclamate, and described aromatic is solid flavoring pineapple essence.
According to the general knowledge of pharmaceutical field, on the basis of above-mentioned amoxicillin dispersible tablet agent prescription, adopt conventional slow release method can further make the slow releasing agent of amoxicillin dispersible tablet.For example, on the basis of above-mentioned amoxicillin dispersible tablet agent prescription,, can obtain the slow releasing agent of amoxicillin dispersible tablet to the slow releasing agent that wherein adds suitable consumption.
Another object of the present invention has provided the method for producing above-mentioned amoxicillin dispersible tablet, and this method may further comprise the steps:
(1) with broken the sieving of the former medicated powder in amoxicillin;
(2) take by weighing three kinds of pharmaceutical carrier diluent, disintegrating agent and lubricants respectively by described proportioning, and optionally add sweeting agent and aromatic, all pharmaceutical carrier premixs, crushing screening;
(3) the product mixing of above-mentioned two steps is sieved; With
(4) with mixed material tabletting, obtain amoxicillin dispersible tablet.
Concrete, the product that above-mentioned steps (1) and (2) are obtained mix sieve after, preferably with resulting compound continuation batch mixing more than 30 minutes, so that this compound mixes very evenly.
Preferably, pharmaceutical carrier diluent used in the above-mentioned dispersible tablet is a micro-crystalline lactose, and disintegrating agent is a crospolyvinylpyrrolidone, and lubricant is a magnesium stearate.
The use amount of used pharmaceutical carrier in the amoxicillin dispersible tablet of the present invention, gross weight in micro-crystalline lactose, crospolyvinylpyrrolidone and three kinds of adjuvant of magnesium stearate, three's percetage by weight is respectively micro-crystalline lactose 60-94%, crospolyvinylpyrrolidone 5-30%, and magnesium stearate 1-20%; Preferably, the optimum ratio of three kinds of adjuvant is: micro-crystalline lactose 75-85%, crospolyvinylpyrrolidone 10-20%, and magnesium stearate 1-5%; Preferred, the proportioning of three kinds of adjuvant is: micro-crystalline lactose 82%, crospolyvinylpyrrolidone 15%, and magnesium stearate 3%.
In amoxicillin dispersible tablet of the present invention, can also contain sweeting agent and/or aromatic, its use amount can be determined according to the general knowledge of this area, is as the criterion to reach the taste that is fit to most patient.Preferably, described sweeting agent is a cyclamate, and described aromatic is solid flavoring pineapple essence.
For the ease of preparation, former powder in used amoxicillin and pharmaceutical carrier should be selected the similar product of granularity for use as far as possible.
Further, prepare the routine techniques of slow releasing agent, on the basis of above-mentioned amoxicillin dispersible tablet agent prescription, adopt conventional slow release method can further make the slow releasing agent of amoxicillin dispersible tablet according to pharmaceutical field.
Most preferred, production method according to amoxicillin dispersible tablet of the present invention, are micro-crystalline lactoses wherein with described three kinds of pharmaceutical carrier diluent, disintegrating agent is a crospolyvinylpyrrolidone, lubricant is a magnesium stearate, in the gross weight of three kinds of pharmaceutical carriers, three's percetage by weight is respectively micro-crystalline lactose (Cellactose-80) 82%, crospolyvinylpyrrolidone 15% and magnesium stearate 3%; Wherein also add an amount of cyclamate and solid flavoring pineapple essence.
Compare with traditional dispersible tablet production method, the method that the present invention produces amoxicillin dispersible tablet has the following advantages:
1, adopt the direct compression method, must add binding agent and water, vapour etc., technological process is short, and is simple to operate, constant product quality.
2, employed adjuvant is reduced to 3 kinds by 6 kinds of traditional method;
3, the tabletting operation is easy to control;
4, the outward appearance of product improves, and can cancel art for coating;
5, the mouthfeel of product improves.
Description of drawings
Fig. 1 is the process chart of amoxicillin dispersible tablet of the present invention;
Fig. 2 is the process chart of traditional handicraft amoxicillin dispersible tablet.
The specific embodiment
Following listed examples is more particularly understood technical scheme of the present invention, but its protection domain that does not limit the present invention in any way.
Embodiment 1Amoxicillin dispersible tablet of the present invention
The amoxicillin dispersible tablet prescription is as follows:
The former powder 1500g in amoxicillin
Micro-crystalline lactose (Cellactose-80) 400g
PVPP 75g
Magnesium stearate 15g
Cyclamate 100g
Flavoring pineapple essence (solid) 50g
The product that the former powder in above-mentioned amoxicillin adopts the safe company limited of elder generation of North China pharmacy group to produce according to pharmacopeia; Above-mentioned micro-crystalline lactose (Cellactose-80) is the product that the happy company of German U.S. agent produces.
According to following method, above-mentioned raw materials is made the amoxicillin dispersible tablet agent:
(1) with broken mistake 30 mesh sieve of the former medicated powder in amoxicillin;
(2) above-mentioned all adjuvants are mixed, pulverize, cross 30 mesh sieves;
(3) product with above-mentioned two steps mixes, and crosses 30 mesh sieves, and then continues batch mixing 40 minutes, makes this compound mix very evenly; With
(4), obtain the dispersible tablet that amoxicillin content is 0.25g with mixed material direct compression.
Prepare three batches of products according to the method described above, how according to conventional method resulting amoxicillin dispersible tablet to be detected, testing result is as follows:
In above-mentioned production tabletting process, diversity is better, and flowability, compressibility, mixing uniformity, dispersing uniformity are all fine.
By detecting data as can be known: this technology preparation is more stable, and every quality index is qualified, stablize suitable direct compression technology.
Below described embodiment of the present invention in detail, can do a lot of improvement and variation obviously for a person skilled in the art and can not deviate from essence spirit of the present invention.All these changes and improvements are all within protection scope of the present invention.
Claims (3)
1. an amoxicillin dispersible tablet wherein is made up of former medicine in amoxicillin and pharmaceutical carrier, and described pharmaceutical carrier comprises diluent, disintegrating agent and lubricant, and optional sweeting agent and/or the aromatic of comprising;
Wherein, the weight ratio of former medicine in described amoxicillin and pharmaceutical carrier is 3: 1;
Diluent in the described pharmaceutical carrier is a micro-crystalline lactose, and disintegrating agent is a crospolyvinylpyrrolidone, and lubricant is a magnesium stearate;
Described pharmaceutical carrier is in its gross weight, and three kinds of adjuvant weight percentage separately is respectively micro-crystalline lactose 82%, crospolyvinylpyrrolidone 15%, and magnesium stearate 3%;
Described micro-crystalline lactose is the complex that microcrystalline Cellulose and spray-dired lactose premix form.
2. according to the described amoxicillin dispersible tablet of claim 1, described sweeting agent is a cyclamate, and described aromatic is solid flavoring pineapple essence.
3. according to the production method of claim 1 or 2 described amoxicillin dispersible tablets, this method may further comprise the steps:
(1) with broken the sieving of the former medicated powder in amoxicillin;
(2) take by weighing three kinds of pharmaceutical carrier diluent, disintegrating agent and lubricants respectively by described proportioning, and optional sweeting agent and/or the aromatic of adding, with all pharmaceutical carrier premixs, crushing screening;
(3) the product mixing of above-mentioned two steps is sieved; With
(4) with mixed material tabletting, obtain amoxicillin dispersible tablet;
Wherein, the compound that obtains that the product of (1), (2) two steps is mixed after sieving continued batch mixing more than 30 minutes;
Described three kinds of pharmaceutical carriers are diluent micro-crystalline lactoses, disintegrating agent crospolyvinylpyrrolidone, magnesium stearate lubricant; In the gross weight of three kinds of pharmaceutical carriers, three's weight percentage is respectively micro-crystalline lactose 82%, crospolyvinylpyrrolidone 15% and magnesium stearate 3%; Wherein also optional cyclamate and/or the solid flavoring pineapple essence of adding;
Described micro-crystalline lactose is the complex that microcrystalline Cellulose and spray-dired lactose premix form.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2008101013323A CN101524333B (en) | 2008-03-04 | 2008-03-04 | Amoxicillin dispersible tablet and production method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2008101013323A CN101524333B (en) | 2008-03-04 | 2008-03-04 | Amoxicillin dispersible tablet and production method thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN101524333A CN101524333A (en) | 2009-09-09 |
| CN101524333B true CN101524333B (en) | 2011-11-30 |
Family
ID=41092516
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2008101013323A Active CN101524333B (en) | 2008-03-04 | 2008-03-04 | Amoxicillin dispersible tablet and production method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN101524333B (en) |
Families Citing this family (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102048704B (en) * | 2009-11-06 | 2012-02-29 | 华北制药股份有限公司 | Levofloxacin lactate dispersible tablet and preparation method thereof |
| CN102258495B (en) * | 2011-07-13 | 2013-01-30 | 石家庄四药有限公司 | Cefprozil tablet and preparation method thereof |
| CN103006589B (en) * | 2011-09-27 | 2015-11-25 | 闫亚梅 | Amoxicillin dispersible tablet and production method thereof |
| CN104161734B (en) * | 2014-09-04 | 2017-03-29 | 海口市制药厂有限公司 | A kind of amoxicillin dispersible tablet, Preparation Method And The Use |
| CN104173310A (en) * | 2014-09-04 | 2014-12-03 | 海口市制药厂有限公司 | Stable amoxicillin tablet composition, as well as preparation method and application thereof |
| CN104758264A (en) * | 2015-04-27 | 2015-07-08 | 四川制药制剂有限公司 | Process for preparing amoxicillin dispersible tablet |
| CN106509372A (en) * | 2016-10-09 | 2017-03-22 | 杨松杞 | New water-soluble carrier and preparation method thereof |
| CN107019677A (en) * | 2017-04-26 | 2017-08-08 | 四川制药制剂有限公司 | The preparation method of amoxicillin dispersible tablet |
| CN108066308A (en) * | 2018-01-19 | 2018-05-25 | 佛山手心制药有限公司 | Amoxicillin effervescent tablet and preparation method thereof |
| CN113143878A (en) * | 2021-03-19 | 2021-07-23 | 杭州新诺华医药有限公司 | Olanzapine composition and preparation method thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1803135A (en) * | 2006-01-24 | 2006-07-19 | 沈阳施德药业有限公司 | Amoxicillin-potsssium clavulanate dispersion tablet |
| CN1968682A (en) * | 2004-06-18 | 2007-05-23 | 株式会社柳韩洋行 | Oral dispersible tablet composition of amoxycillin and/or clavulanic acid comprising a surface-modified sodium bicarbonate |
-
2008
- 2008-03-04 CN CN2008101013323A patent/CN101524333B/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1968682A (en) * | 2004-06-18 | 2007-05-23 | 株式会社柳韩洋行 | Oral dispersible tablet composition of amoxycillin and/or clavulanic acid comprising a surface-modified sodium bicarbonate |
| CN1803135A (en) * | 2006-01-24 | 2006-07-19 | 沈阳施德药业有限公司 | Amoxicillin-potsssium clavulanate dispersion tablet |
Also Published As
| Publication number | Publication date |
|---|---|
| CN101524333A (en) | 2009-09-09 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN101524333B (en) | Amoxicillin dispersible tablet and production method thereof | |
| CN103083278B (en) | Roxithromycin capsule and preparation method thereof | |
| CN103610677B (en) | A kind of Repaglinide tablet and its preparation method | |
| CN102988993A (en) | Screening and composition of main auxiliary materials of compound acetaminophen tablet, and preparation method of compound acetaminophen tablet | |
| CN109925290B (en) | Theophylline sustained release tablet and preparation process thereof | |
| CN101744852B (en) | Preparation method of acanthopanax effervescent tablet and products thereof | |
| CN103720660A (en) | VB2 (vitamin B2) granule and preparation method thereof | |
| CN103142506B (en) | Cefpodoxime proxetil granules and preparation method thereof | |
| CN102302466A (en) | Capecitabine medicinal composition capable of direct powder tableting, and application thereof | |
| CN104161734B (en) | A kind of amoxicillin dispersible tablet, Preparation Method And The Use | |
| CN103007286B (en) | General smooth solid composite medicament is cut down in a kind of holder | |
| CN101011362A (en) | Dispersible tablet of pidotimod and its preparing process and use | |
| CN102755300A (en) | Voriconazole composition and preparation method thereof | |
| CN106880611A (en) | A kind of tolvaptan preparation of tolvaptan and water soluble adjuvant containing micronizing | |
| CN102552211B (en) | Preparation composite of agomelatine and preparation method thereof | |
| JP4774739B2 (en) | Kampo extract-containing tablet composition and method for producing the same | |
| CN107661305A (en) | A kind of Norfloxacin composition | |
| CN109700773B (en) | Ticagrelor preparation composition and preparation method thereof | |
| CN104173310A (en) | Stable amoxicillin tablet composition, as well as preparation method and application thereof | |
| CN112704668B (en) | Pramipexole dihydrochloride sustained-release composition | |
| CN104352465B (en) | Prucalopride succinate pharmaceutical composition free of silicon dioxide and preparation method of prucalopride succinate pharmaceutical composition | |
| CN103340855A (en) | Compound amoxicillin and clavulanate potassium tablet and preparation method thereof | |
| CN100471497C (en) | Naloxone Hydrochloride nose powder preparation | |
| CN103099825B (en) | Novel cordyceps sinensis capsule and preparation method thereof | |
| CN102988372A (en) | Screening and composition of main auxiliary materials of compound aspirin tablet, and preparation method of compound aspirin sheet |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| ASS | Succession or assignment of patent right |
Owner name: HUABEI PHARMACEUTICAL CO., LTD. Free format text: FORMER OWNER: WANG ZHILIANG Effective date: 20110919 |
|
| C41 | Transfer of patent application or patent right or utility model | ||
| COR | Change of bibliographic data |
Free format text: CORRECT: ADDRESS; FROM: 050015 SHIJIAZHUANG, HEBEI PROVINCE TO: 050011 SHIJIAZHUANG, HEBEI PROVINCE |
|
| TA01 | Transfer of patent application right |
Effective date of registration: 20110919 Address after: 050011 China in Hebei province Shijiazhuang city peace road Howard Street No. 6 Applicant after: Huabei Pharmaceutical Co., Ltd. Address before: 050015 No. 135 North sports street, Hebei, Shijiazhuang Applicant before: Wang Zhiliang |
|
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant |