CN109908354A - Sertraline hydrochloride takes orally concentrate and its preparation process - Google Patents
Sertraline hydrochloride takes orally concentrate and its preparation process Download PDFInfo
- Publication number
- CN109908354A CN109908354A CN201711315834.1A CN201711315834A CN109908354A CN 109908354 A CN109908354 A CN 109908354A CN 201711315834 A CN201711315834 A CN 201711315834A CN 109908354 A CN109908354 A CN 109908354A
- Authority
- CN
- China
- Prior art keywords
- concentrate
- sertraline hydrochloride
- takes orally
- antioxidant
- magnetic agitation
- 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
This application involves medicine field, specially sertraline hydrochloride takes orally concentrate and its preparation process.The oral solution prescription is made of sertraline hydrochloride, glycerol, ethyl alcohol, antioxidant, sweetener, essence.Compared with Conventional solid preparation such as tablet, capsule, oral solution dispersion degree is big, absorbs fast, bioavilability height.Meanwhile the compliance of patient has can be improved in oral solution, and it is convenient that there is the patient for swallowing oral solid formulation difficulty to use, guarantee the accuracy of dosage.In addition, the present invention uses antioxidant butylhydroxy anisole (BHA), related substance can be reduced, keeps preparation nature more stable.
Description
Technical field
The invention belongs to pharmaceutical technology fields, and in particular to a kind of sertraline hydrochloride takes orally concentrate and its preparation process.
Background technique
Sertraline is newest one kind in selective serotonin recycling inhibitor, can help the ability for improving body,
Effectively mitigate the depressive symptom of patient, including irritated mood, and the fatigue symptom and anxiety state of duration can be mitigated, has
There is the features such as long-acting, low to hepatotoxicity, internal removing is fast, has been widely used to treatment depressibility and mandatory essence in the world
Refreshing obstacle.Pfizer drugmaker, which is developed, takes orally concentrate and tablet for sertraline hydrochloride, and trade name ZOLOFT(is left
Lip river is multiple) at present in multiple country's listings.
Compared with Conventional solid preparation such as tablet, capsule, oral solution dispersion degree is big, absorbs fast, bioavilability height.Together
When, oral solution can be improved the compliance of patient, convenient to have the patient's use for swallowing oral solid formulation difficulty, guarantee to
The accuracy of pharmaceutical quantities.In addition, this patent uses antioxidant butylhydroxy anisole (BHA), related substance can be reduced, makes to make
Agent property is more stable.
Summary of the invention
The purpose of the application is to provide a kind of sertraline hydrochloride and takes orally concentrate and its preparation process, the application's
Purpose is solved by following scheme:
The sertraline hydrochloride takes orally concentrate, containing sertraline hydrochloride, glycerol, ethyl alcohol, antioxidant, sweetener, essence and
Pure water.
The sertraline hydrochloride takes orally concentrate, and antioxidant is butylhydroxy anisole (BHA), 2,6- di-t-butyl
Hydroxy-methylbenzene (BHT), vitamin E, ascorbyl palmitate one or both more than mixture, preferred tert-butyl hydroxy
Anisole (BHA).
The sertraline hydrochloride takes orally concentrate, sweetener be D-sorbite, mannitol, fructose, sucrose, maltose,
Mixture more than one or both of lactose, glucose, xylitol, saccharin sodium, aspartame, stevioside, preferably Ah Si
Pa Tan.
The sertraline hydrochloride takes orally concentrate, and essence is apple, honey peach, cherry, orange taste, strawberry, in "Hami" melon
One or both more than mixture.
The sertraline hydrochloride takes orally concentrate, the ingredient comprising following ratio:
The sertraline hydrochloride takes orally concentrate, and antioxidant, sweetener, essence are added to magnetic force in the ethyl alcohol of recipe quantity and stirred
Dissolution is mixed, is poured into volumetric flask, a certain amount of glycerol constant volume is added.It pours into beaker, magnetic agitation is uniformly mixed, and prescription is added
The bulk pharmaceutical chemicals of amount carry out magnetic agitation dissolution, and ultrasound 15min bubble removing is carried out after dissolution, both obtain sample.
Specific embodiment
This application involves sertraline hydrochlorides to take orally concentrate and its preparation process, and those skilled in the art can use for reference herein
Content is suitably modified realization of process parameters.In particular, it should be pointed out that all similar substitutions and modifications are to those skilled in the art
It is it will be apparent that they are considered as being included in the present invention for member.The present processes and application have passed through preferably real
Example is applied to be described, related personnel obviously can not depart from teachings herein, in spirit and scope to method described herein
It is modified or appropriate changes and combinations with application, carrys out implementation and application the technology of the present invention.
Embodiment 1:
Preparation process:
Antioxidant, sweetener, essence are added to magnetic agitation in the ethyl alcohol of recipe quantity to dissolve, pours into volumetric flask, is added one
Quantitative glycerol constant volume.It pours into beaker, magnetic agitation is uniformly mixed, and the bulk pharmaceutical chemicals progress magnetic agitation that recipe quantity is added is molten
Solution carries out ultrasound 15min bubble removing after dissolution, both obtain sample.
Embodiment 2:
Preparation process:
Antioxidant, sweetener, essence are added to magnetic agitation in the ethyl alcohol of recipe quantity to dissolve, pours into volumetric flask, is added one
Quantitative glycerol constant volume.It pours into beaker, magnetic agitation is uniformly mixed, and the bulk pharmaceutical chemicals progress magnetic agitation that recipe quantity is added is molten
Solution carries out ultrasound 15min bubble removing after dissolution, both obtain sample.
Embodiment 3:
Preparation process:
Antioxidant, sweetener, essence are added to magnetic agitation in the ethyl alcohol of recipe quantity to dissolve, pours into volumetric flask, is added one
Quantitative glycerol constant volume.It pours into beaker, magnetic agitation is uniformly mixed, and the bulk pharmaceutical chemicals progress magnetic agitation that recipe quantity is added is molten
Solution carries out ultrasound 15min bubble removing after dissolution, both obtain sample.
Embodiment 4:
Preparation process:
Antioxidant, sweetener, essence are added to magnetic agitation in the ethyl alcohol of recipe quantity to dissolve, pours into volumetric flask, is added one
Quantitative glycerol constant volume.It pours into beaker, magnetic agitation is uniformly mixed, and the bulk pharmaceutical chemicals progress magnetic agitation that recipe quantity is added is molten
Solution carries out ultrasound 15min bubble removing after dissolution, both obtain sample.
Embodiment 5:
Preparation process:
Antioxidant, sweetener, essence are added to magnetic agitation in the ethyl alcohol of recipe quantity to dissolve, pours into volumetric flask, is added one
Quantitative glycerol constant volume.It pours into beaker, magnetic agitation is uniformly mixed, and the bulk pharmaceutical chemicals progress magnetic agitation that recipe quantity is added is molten
Solution carries out ultrasound 15min bubble removing after dissolution, both obtain sample.
Comparative example 1:
Preparation process:
Antioxidant, sweetener, essence are added to magnetic agitation in the ethyl alcohol of recipe quantity to dissolve, pours into volumetric flask, is added one
Quantitative glycerol constant volume.It pours into beaker, magnetic agitation is uniformly mixed, and the bulk pharmaceutical chemicals progress magnetic agitation that recipe quantity is added is molten
Solution carries out ultrasound 15min bubble removing after dissolution, both obtain sample.
Related material result:
Embodiment 1,2,3,4,5 is miscellaneous, always miscellaneous in relation to the maximum unknown list of substance to be significantly better than that comparison compared with comparative example 1
Embodiment, embodiment 1,4,5 select antioxidant butylhydroxy anisole (BHA), and the related maximum unknown list of substance is miscellaneous, total miscellaneous equal
It is substantially better than embodiment 2,3, the preferred butylhydroxy anisole of antioxidant (BHA).
Compared with Conventional solid preparation such as tablet, capsule, oral solution dispersion degree is big, absorbs fast, bioavilability height.Together
When, oral solution can be improved the compliance of patient, convenient to have the patient's use for swallowing oral solid formulation difficulty, guarantee to
The accuracy of pharmaceutical quantities.In addition, this patent uses antioxidant butylhydroxy anisole (BHA), related substance can be reduced, makes to make
Agent property is more stable.
Claims (7)
1. a kind of sertraline hydrochloride takes orally concentrate, containing sertraline hydrochloride, glycerol, ethyl alcohol, antioxidant, sweetener, essence and
Pure water.
2. sertraline hydrochloride according to claim 1 takes orally concentrate, antioxidant be butylhydroxy anisole (BHA),
2,6- di-tert-butyl hydroxy toluenes (BHT), vitamin E, ascorbyl palmitate one or both more than mixture, it is excellent
Selecting antioxidant is butylhydroxy anisole (BHA).
3. sertraline hydrochloride according to claim 2 takes orally concentrate, antioxidant is butylhydroxy anisole (BHA)
Amount ranges are 0.1 ~ 1.5 %.
4. sertraline hydrochloride according to claim 1 takes orally concentrate, sweetener is D-sorbite, mannitol, fructose, sugarcane
Mixing more than one or both of sugar, maltose, lactose, glucose, xylitol, saccharin sodium, aspartame, stevioside
Object, preferably aspartame.
5. sertraline hydrochloride according to claim 1 takes orally concentrate, essence is apple, honey peach, cherry, orange taste, grass
The certain kind of berries, mixture more than one or both of "Hami" melon.
It include following proportional components 6. sertraline hydrochloride according to claim 1 takes orally concentrate
。
7. sertraline hydrochloride described in -6 takes orally concentrate according to claim 1, the preparation method comprises the following steps: by antioxidant, sweetener, perfume (or spice)
Finishing enters into the ethyl alcohol of recipe quantity magnetic agitation dissolution, pours into volumetric flask, a certain amount of glycerol constant volume is added；Pour into beaker
In, magnetic agitation is uniformly mixed, and the bulk pharmaceutical chemicals that recipe quantity is added carry out magnetic agitation dissolution, and ultrasound 15min is carried out after dissolution and is removed
Bubble both obtains sample.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201711315834.1A CN109908354A (en) | 2017-12-12 | 2017-12-12 | Sertraline hydrochloride takes orally concentrate and its preparation process |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201711315834.1A CN109908354A (en) | 2017-12-12 | 2017-12-12 | Sertraline hydrochloride takes orally concentrate and its preparation process |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN109908354A true CN109908354A (en) | 2019-06-21 |
Family
ID=66957456
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201711315834.1A Pending CN109908354A (en) | 2017-12-12 | 2017-12-12 | Sertraline hydrochloride takes orally concentrate and its preparation process |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN109908354A (en) |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1261794A (en) * | 1997-07-01 | 2000-08-02 | 辉瑞产品公司 | Solubilized sertraline compositions |
| CN1323202A (en) * | 1998-10-13 | 2001-11-21 | 辉瑞产品公司 | Sertraline oral concentrate |
| US20030096868A1 (en) * | 1998-10-13 | 2003-05-22 | Nancy J. Harper | Sertraline oral concentrate |
| CN101623252A (en) * | 2008-07-09 | 2010-01-13 | 北京德众万全药物技术开发有限公司 | Sertraline hydrochloride oral liquid and preparation method thereof |
| CN101632632A (en) * | 2008-07-21 | 2010-01-27 | 北京迈劲医药科技有限公司 | Sertraline oral aqueous solution and preparation method |
-
2017
- 2017-12-12 CN CN201711315834.1A patent/CN109908354A/en active Pending
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1261794A (en) * | 1997-07-01 | 2000-08-02 | 辉瑞产品公司 | Solubilized sertraline compositions |
| CN1323202A (en) * | 1998-10-13 | 2001-11-21 | 辉瑞产品公司 | Sertraline oral concentrate |
| US20030096868A1 (en) * | 1998-10-13 | 2003-05-22 | Nancy J. Harper | Sertraline oral concentrate |
| CN101623252A (en) * | 2008-07-09 | 2010-01-13 | 北京德众万全药物技术开发有限公司 | Sertraline hydrochloride oral liquid and preparation method thereof |
| CN101632632A (en) * | 2008-07-21 | 2010-01-27 | 北京迈劲医药科技有限公司 | Sertraline oral aqueous solution and preparation method |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| US11590100B2 (en) | Composition for buccal or sublingual administration of cannabis extract and methods for making same | |
| Keshavarao et al. | Formulation and evaluation of mouth dissolving film containing Rofecoxib | |
| CA2958925C (en) | Natural suspending agent including a synergistic blend of xanthan gum and konjac powder for oral pharmaceutical suspensions | |
| JP2011502974A (en) | Methods of hormone suppression in humans | |
| CN102159196B (en) | Pharmaceutical formulation for treating upper digestive tract | |
| WO2007019184A2 (en) | Oral suspension of prednisolone acetate | |
| CN105434351B (en) | A kind of compound fluocinonide spray and preparation method thereof | |
| CN104997741A (en) | Orally disintegrating tablet containing sertraline and preparation method thereof | |
| Kini et al. | Investigating the suitability of Isomalt and liquid glucose as sugar substitute in the formulation of Salbutamol sulfate hard candy lozenges | |
| CN108366961A (en) | Rapidly-soluble diphenhydramine peroral dosage form | |
| TWI648071B (en) | Dosage formulation of opioid receptor modulator | |
| WO2020139240A1 (en) | Pharmaceutics composition providing extended release comprising ibuprofen, pseudoephedrine and erdosteine | |
| WO2011109367A2 (en) | Methods and compositions for treating or preventing symptoms of hormonal variations | |
| CN109908354A (en) | Sertraline hydrochloride takes orally concentrate and its preparation process | |
| JP6800970B2 (en) | Oral suspension of physically and chemically stable Gibinostat | |
| CN111773203A (en) | Preparation process of phenylephrine hydrochloride-containing composition | |
| CA2835912A1 (en) | Pharmaceutical composition comprising fexofenadine | |
| ES2209490T3 (en) | ORAL SERTRALINE CONCENTRATE. | |
| Musko et al. | The use of compounded dispersing media for extemporaneous pediatric syrups with candesartan cilexetil and valsartan | |
| Yahyaei et al. | Healing effects of Ziziphus jujuba hydroalcoholic extract with exercise training on histopathological changes of male wistar rats testicular tissue in response to Boldenone steroid administration | |
| Katayama et al. | In vivo drug dissolution in human oral cavity from orally disintegrating tablet and comparability with in vitro testing | |
| MX2014004008A (en) | Pharmaceutical methods and topical compositions containing acitretin. | |
| Reddy et al. | Formulation development and evaluation of medroxyprogesterone acetate injectable suspension | |
| CN1509720A (en) | Progesterone capsule and preparing method thereof | |
| RU2771084C2 (en) | Pharmaceutical composition for buccal/gingian introduction of paracetamol |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| WD01 | Invention patent application deemed withdrawn after publication |
Application publication date: 20190621 |
|
| WD01 | Invention patent application deemed withdrawn after publication |