CN101548958B - Dispersing tablet containing terbinafine hydrochloride - Google Patents
Dispersing tablet containing terbinafine hydrochloride Download PDFInfo
- Publication number
- CN101548958B CN101548958B CN 200810103327 CN200810103327A CN101548958B CN 101548958 B CN101548958 B CN 101548958B CN 200810103327 CN200810103327 CN 200810103327 CN 200810103327 A CN200810103327 A CN 200810103327A CN 101548958 B CN101548958 B CN 101548958B
- Authority
- CN
- China
- Prior art keywords
- terbinafine hcl
- dispersible tablet
- terbinafine hydrochloride
- dispersing tablet
- tablet
- 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
Abstract
The invention discloses a dispersing tablet containing terbinafine hydrochloride. The dispersing tablet comprises active components of the terbinafine hydrochloride and medical auxiliary materials andis clinically used for killing or inhibiting fungus.
Description
Technical field
The invention belongs to medical technical field, particularly a kind of dispersible tablet that contains terbinafine HCl.
Background technology
Terbinafine HCl ((E)-N-(6,6-dimethyl-2 heptene-4-alkynes)-N methyl isophthalic acid-naphthalene methylamine hydrochloric salt) is a kind of propylamine medicine of broad-spectrum antifungal activity, the early stage biosynthesis of the interference mycosterol that these article can be special; Highly selective suppresses the Squalene Cycloxygenase of fungus; Ground Squalene epoxidation reaction is obstructed, thereby reaches the effect of killing or suppressing fungus, determined curative effect; And toxic and side effects is slight, has vast potential for future development.
The conventional formulation of terbinafine HCl is many to be main with external, for oral formulations, present clinical use be merely ordinary tablet and capsule.Terbinafine HCl is a kind of chemical compound of slightly solubility; Its stripping is the rate-limiting step that medicine absorbs in vivo and utilizes, and the method for raising solid preparation stripping commonly used mainly contains: improve binding agent disintegrating agent in the prescription etc. selection, improve supplementary material hybrid technique, solid dispersion technology and cyclodextrin inclusion technique.At present; The related patent U.S. Patent No. of terbinafine HCl does not have the people deeply to inquire into to the stripping that how to improve its solid preparation as yet; And people also need a kind of commercial receptible, to patient, especially convenient and receptible terbinafine HCl oral formulations to child and old man, the present invention provides a kind of dispersible tablet that contains terbinafine HCl.Dispersible tablet has advantages such as drug release rate is fast, bioavailability is high, untoward reaction is few; Clinical application both can be swallowed as ordinary tablet; Can put into water again and take after the dispersion rapidly, can also chewing or containing to suck of having taken, and portably uses conveniently; Have the advantage of tablet and liquid preparation concurrently, the very convenient old man of the tablet of this quick dissolved, quick effect, child and the difficult person that swallows use.
A kind of Terbinafine hydrochloride vagina gel and method for making thereof and method of quality control are disclosed among the CN1813697A.
Disclose a kind of capsule preparations of terbinafine HCl among the CN1440746A, compared with dispersible tablet, capsule does not possess quick-acting quick-dissolving characteristics, and the difficult person that is not suitable for swallowing uses.
Disclose a kind of pharmaceutical composition and application thereof that contains terbinafine among the CN1527706A, it is characterized in that improving the comprehensive safety property of terbinafine HCl, terbinafine HCl used in the present invention is the safe and effective dosage through clinical verification.
Summary of the invention
The purpose of this invention is to provide a kind of dispersible tablet that contains terbinafine HCl, this dispersible tablet through self dosage form advantage and improve the selection of filler, can make the better stripping of active ingredient hydrochloric acid terbinafine.
Terbinafine HCl dispersible tablet provided by the invention is a kind of dispersible tablet that contains the solubility filler, meets water and can form even suspension immediately, has taking convenience, rapid, the simple advantage of production technology of stripping.
Terbinafine HCl dispersible tablet provided by the invention, clinical application both can be swallowed as ordinary tablet, can put into again to take after water disperses rapidly, and can also chewing or containing to suck of having taken, and portably uses conveniently, has the advantage of tablet and liquid preparation concurrently.
Dispersible tablet provided by the invention contains filler, binding agent, disintegrating agent, lubricant, correctives as suitable adjuvant of the present invention.
Dispersible tablet provided by the present invention; Contain water-soluble filler and water-insoluble filler as suitable filler of the present invention; Wherein water-soluble filler can be selected from one or more in lactose, sorbitol, mannitol, the sucrose, and the water-insoluble filler can be selected from one or more in microcrystalline Cellulose, calcium hydrogen phosphate, starch, the pregelatinized Starch.
Dispersible tablet provided by the present invention contains in the water-soluble filler one or more at least as being fit to filler of the present invention.
The present invention is through selection, and disintegrating agent can be selected from one or more in carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, crospolyvinylpyrrolidone, the cross-linking sodium carboxymethyl cellulose in the adjuvant.
In order to improve the taste of tablet, can also add an amount of correctives,, glycyrrhizin sweet like A Siba, sucralose, medicinal essence etc. in order to guarantee the stable of principal agent, can also add an amount of antioxidant and antiseptic etc.
Dispersible tablet disclosed by the invention is used to kill or suppress fungus.
The specific embodiment
Come composition and method of making the same of the present invention done further specifying through following examples, but be not limited in following instance.
The comparative example 1:
Preparation technology: take by weighing recipe quantity terbinafine HCl and starch, calcium hydrogen phosphate, microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose by recipe quantity, mixing, the system soft material is crossed 20 mesh sieves and is granulated drying, 24 mesh sieve granulate; The magnesium stearate, the citric acid mixing that add the prescription ratio, tabletting.
Embodiment 1:
Preparation technology: take by weighing terbinafine HCl and lactose, mannitol, microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose by recipe quantity, mixing, the system soft material is crossed 20 mesh sieves and is granulated drying, 24 mesh sieve granulate; The magnesium stearate, the citric acid mixing that add the prescription ratio, tabletting.
Embodiment 2:
Preparation technology: take by weighing terbinafine HCl and lactose, xylitol, polyvidone, carboxymethyl starch sodium by recipe quantity, mixing, the system soft material is crossed 20 mesh sieves and is granulated drying, 24 mesh sieve granulate; The grape essence, the magnesium stearate mixing that add the prescription ratio, tabletting.
Embodiment 3
Preparation technology: take by weighing terbinafine HCl and Polyethylene Glycol by recipe quantity, mannitol, low-substituted hydroxypropyl cellulose, sucrose, mixing, the system soft material is crossed 20 mesh sieves and is granulated drying, 24 mesh sieve granulate; The hami melon essence, the magnesium stearate mixing that add the prescription ratio, tabletting.
Embodiment 1～3 and comparative example 1, commercially available conventional tablet dissolution be (n=6, X ± SD) relatively
The result shows: dispersible tablet all is significantly higher than commercially available conventional tablet at the dissolution rate of each time point, and embodiment 1 makes sample all is superior to comparative example 1 in the stripping of each time point sample.
Claims (1)
1. dispersible tablet that contains terbinafine HCl, it consists of:
Its preparation method is: take by weighing terbinafine HCl, and lactose, xylitol, polyvidone, carboxymethyl starch sodium, mixing, the system soft material is crossed 20 mesh sieves and is granulated drying, 24 mesh sieve granulate; Add grape essence, magnesium stearate mixing, tabletting.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200810103327 CN101548958B (en) | 2008-04-03 | 2008-04-03 | Dispersing tablet containing terbinafine hydrochloride |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200810103327 CN101548958B (en) | 2008-04-03 | 2008-04-03 | Dispersing tablet containing terbinafine hydrochloride |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN101548958A CN101548958A (en) | 2009-10-07 |
| CN101548958B true CN101548958B (en) | 2012-10-17 |
Family
ID=41153601
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200810103327 Active CN101548958B (en) | 2008-04-03 | 2008-04-03 | Dispersing tablet containing terbinafine hydrochloride |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN101548958B (en) |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102198111A (en) * | 2011-06-17 | 2011-09-28 | 哈尔滨乐泰药业有限公司 | Preparation method of antifungal tablet |
| CN104666257B (en) * | 2013-12-03 | 2017-09-15 | 长春海悦药业股份有限公司 | A kind of pharmaceutical composition containing terbinafine HCl |
| CN104523645A (en) * | 2014-11-20 | 2015-04-22 | 美吉斯制药（厦门）有限公司 | Paroxetine mesylate tablet core, and preparation method of coated tablet of paroxetine mesylate |
| CN110200929A (en) * | 2018-12-14 | 2019-09-06 | 悦康药业集团上海制药有限公司 | A kind of oral tablet and preparation method thereof containing terbinafine HCl |
| CN117085135A (en) * | 2023-09-28 | 2023-11-21 | 哈尔滨商业大学 | Use of squalene epoxidase inhibitor in preparation of medicine for treating endometrial cancer |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1279944A (en) * | 1999-07-08 | 2001-01-17 | 齐鲁制药厂 | Effervescent tablets for curing vaginitis and its preparing method |
| CN1337876A (en) * | 1999-01-27 | 2002-02-27 | R.P.斯克尔公司 | Fast dispersing dosage forms free of gelatin |
-
2008
- 2008-04-03 CN CN 200810103327 patent/CN101548958B/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1337876A (en) * | 1999-01-27 | 2002-02-27 | R.P.斯克尔公司 | Fast dispersing dosage forms free of gelatin |
| CN1279944A (en) * | 1999-07-08 | 2001-01-17 | 齐鲁制药厂 | Effervescent tablets for curing vaginitis and its preparing method |
Also Published As
| Publication number | Publication date |
|---|---|
| CN101548958A (en) | 2009-10-07 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| TWI257311B (en) | Rapidly disintegrable solid preparation | |
| JP5421775B2 (en) | Oxycodone-containing granules and orally disintegrating tablets | |
| JP5859664B2 (en) | Oral pharmaceutical composition with masked taste of drug and method for producing the same | |
| RU2401109C2 (en) | Tablet-form slow-release preparation for vertigo | |
| WO2000078292A1 (en) | Quickly disintegrating solid preparations | |
| JP2008531681A (en) | Fast disintegrating preparation containing magnesium carbonate heavy | |
| CN103813785A (en) | New abuse-resistant pharmaceutical composition for the treatment of opioid dependence | |
| CN101548958B (en) | Dispersing tablet containing terbinafine hydrochloride | |
| CA2182004C (en) | Film coated tablet of paracetamol and domperidone | |
| AU2011247642C1 (en) | Orally disintegrating tablet containing acarbose | |
| JP2983973B1 (en) | Oral fast disintegrating solid preparation | |
| EP2745848B1 (en) | Orally disintegrating tablet containing hydroxyalkyl cellulose fine particles | |
| DK2849730T3 (en) | New alfentanyl composition for the treatment of acute pain | |
| KR20100086140A (en) | A composition of fast dissolving tablets containing montelukast and it's manufacturing thereof | |
| JP2013533881A (en) | Pharmaceutical composition containing vanoxerin | |
| JP2010241760A (en) | Tablet quickly disintegrable in oral cavity that has unpleasant taste reduced, and method for preparing the same | |
| CN102232929A (en) | Voriconazole dried suspension and preparation method thereof | |
| JP2011246428A (en) | Orally disintegrating medicine and production method | |
| CN101390861A (en) | Solid medicine composition containing voriconazole | |
| US20110060008A1 (en) | Pharmaceutical composition containing acetylcholine esterase inhibitor and method for the preparation thereof | |
| JP5275815B2 (en) | Orally disintegrating tablets and bitterness-suppressing preparations containing risperidone | |
| JP2007332063A (en) | Povidone-iodine-containing intraoral disintegration type solid preparation | |
| KR20140076998A (en) | Bitter taste masked pharmaceutical formulation comprising esomeprazole free base or alkali salt thereof and preparation method thereof | |
| CN101926798B (en) | Dispersible tablet containing amlodipine and valsartan | |
| CN101152187A (en) | Eplerenone pharmaceutical composition |
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: VENTURE PHARMACEUTICAL (HAINAN) CO., LTD. Free format text: FORMER OWNER: DEZHONG WANQUAN PHARMACEUTICALS TECH. DEV. CO., LTD., BEIJING Effective date: 20120530 |
|
| C41 | Transfer of patent application or patent right or utility model | ||
| COR | Change of bibliographic data |
Free format text: CORRECT: ADDRESS; FROM: 100097 HAIDIAN, BEIJING TO: 570314 HAIKOU, HAINAN PROVINCE |
|
| TA01 | Transfer of patent application right |
Effective date of registration: 20120530 Address after: 570314 Nanhai Avenue, Hainan, Haikou, China, No. 279 Applicant after: Beijing D-Venturepharm Technology Development Co., Ltd. Address before: 100097 Beijing city Haidian District Sijiqing Wanquan Zhuang 3 Building Applicant before: Dezhong Wanquan Pharmaceuticals Tech. Dev. Co., Ltd., Beijing |
|
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant |