CN102743335A - Timolol hydrogenmaleate eye drops and preparation method thereof - Google Patents
Timolol hydrogenmaleate eye drops and preparation method thereof Download PDFInfo
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- CN102743335A CN102743335A CN2012102676058A CN201210267605A CN102743335A CN 102743335 A CN102743335 A CN 102743335A CN 2012102676058 A CN2012102676058 A CN 2012102676058A CN 201210267605 A CN201210267605 A CN 201210267605A CN 102743335 A CN102743335 A CN 102743335A
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- eye drops
- timolol maleate
- timolol
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Abstract
The invention provides timolol hydrogenmaleate eye drops, comprising timolol hydrogenmaleate, an isotonizing agent, a thickener, and a stabilizing agent, wherein glycerol is used as the isotonizing agent, the thickener and the stabilizing agent and plays a stabilizing role in the timolol hydrogenmaleate eye drops since glycerol has osmosis and thickening functions. According to the invention, glycerol is used as the isotonizing agent, the thickener and the stabilizing agent, and the effect that one raw material has multiple functions is achieved, so that the timolol hydrogenmaleate eye drops can be produced conveniently and can be applied comfortably without irritation; moreover, since glycerol which is used as the isotonizing agent, the thickener and the stabilizing agent in the timolol hydrogenmaleate eye drops, the stability of the medicine is increased and the clinical functions of the timolol hydrogenmaleate eye drops are ensured. In addition, the invention also provides a preparation method of the timolol hydrogenmaleate eye drops.
Description
Technical field
The present invention relates to a kind of Timolol maleate eye drops and preparation method thereof.
Background technology
Timolol maleate eye drops reduces the eye of intraocular pressure and uses medicine for being used for prevention, treatment glaucoma.Timolol maleate eye drops on the market is generally the product that does not contain thickening agent, stabilizing agent; Have plenty of with sodium chloride is isotonic agent; Or hydroxypropyl emthylcellulose is stabilizing agent and thickening agent; Above-mentioned Timolol maleate eye drops stability is poor, in sampling procedure, has a lot of product adularescent white points or white precipitate to produce, and influences clinical effectiveness during use.
Summary of the invention
The technical problem that the present invention will solve provides a kind of Timolol maleate eye drops, requires the good stability of this Timolol maleate eye drops; The method for preparing of this Timolol maleate eye drops also need be provided in addition.
For solving the problems of the technologies described above, the invention provides a kind of Timolol maleate eye drops, comprise timolol maleate, isotonic agent, thickening agent, stabilizing agent.
Said isotonic agent, thickening agent, stabilizing agent are glycerol.
Glycerol characteristic: achromatism and clarity thick liquid.Odorless.Warm sweet taste is arranged.Relative density (water=1): 1.26331 (20 ℃), viscosity (20 ℃): 1412mPa.s, (25 ℃): 945mPa.s.Aspect medical science, glycerol is commonly used to produce various preparations, solvent, hygroscopic agent, antifreezing agent and sweeting agent, ingredients externally-applied ointment or suppository etc.
Because of glycerol has osmosis, thickness effect, in Timolol maleate eye drops, has Stabilization.Selecting for use glycerol as stabilizing agent, isotonic agent, thickening agent, is to play multiple action with a kind of raw material, both can guarantee convenient for productionly, and uses comfortablely, does not have zest.Therefore, the glycerol among the present invention can strengthen the stability of medicine as isotonic agent, thickening agent, stabilizing agent, guarantees the clinical effect of Timolol maleate eye drops.
As optimization of the present invention, also comprise pH value regulator, antibacterial, water for injection in said a kind of Timolol maleate eye drops.
Said pH value regulator is phosphate buffer or borate buffer solution.
The addition of pH value regulator is for guaranteeing that the product pH value is between the 6.9-7.2.
Said antibacterial is any in benzalkonium chloride, benzalkonium bromide, hibitane, methyl hydroxybenzoate, propyl hydroxybenzoate, benzoic acid, the sodium benzoate.
The advantage of a kind of Timolol maleate eye drops of the present invention is described through two contrast tests below.
First contrast test:
1, test recipe is formed:
Timolol maleate 3.42g
PH value regulator: sodium hydrogen phosphate 8.95 g
Sodium dihydrogen phosphate 1.30 g
Isotonic agent, thickening agent, stabilizing agent: glycerol 10ml
Antibacterial: benzalkonium bromide 1ml
Add the injection water to 1000ml
Fill is produced totally 198
2, the contrast test prescription is formed:
Timolol maleate 3.42g
PH value regulator sodium hydrogen phosphate 8.95 g
Sodium dihydrogen phosphate 1.30 g
Isotonic agent sodium chloride 5.5g
Antibacterial benzalkonium bromide 1ml
Add the injection water to 1000ml
Fill is produced totally 201
3, comparing result: test recipe of the present invention with sodium chloride as the contrast of the contrast test of isotonic agent prescription; Deposit at ambient temperature and investigated visible foreign matters in 6 months; The present invention's 198 visible foreign matters situation of writing out a prescription are 0, have 5 white precipitates to occur in 201 of the contrast test prescriptions.
Second contrast test:
1, test recipe is formed:
Timolol maleate 3.42g
PH value regulator sodium hydrogen phosphate 8.95 g
Sodium dihydrogen phosphate 1.30 g
Isotonic agent, thickening agent, stabilizing agent glycerol 10ml
Antibacterial benzalkonium bromide 1ml
Add the injection water to 1000ml
Fill is produced totally 198
2, the contrast test prescription is formed:
Timolol maleate 3.42g
PH value regulator sodium hydrogen phosphate 8.95 g
Sodium dihydrogen phosphate 1.30 g
Isotonic agent sodium chloride 5.5 g
Thickening agent, stabilizing agent hydroxypropyl emthylcellulose 3.0g
Antibacterial benzalkonium bromide 1ml
Add the injection water to 1000ml
Fill is produced totally 199
Test recipe of the present invention; Be the contrast prescription contrast of stabilizing agent and thickening agent as isotonic agent and hydroxypropyl emthylcellulose with sodium chloride; Deposit at ambient temperature and investigated visible foreign matters in 6 months; The present invention's 198 visible foreign matters situation of writing out a prescription are 0, and 199 of contrast test prescriptions have 4 white white points, 2 to occur and white precipitates occur.
In sum, a kind of Timolol maleate eye drops of the present invention has the advantage of good stability, and uses comfortablely, does not have zest.
The method for preparing of said a kind of Timolol maleate eye drops may further comprise the steps:
(1) get timolol maleate and glycerol, sodium hydrogen phosphate, sodium dihydrogen phosphate dissolves with proper amount of water for injection, medicinal liquid, medicinal liquid is heated to boiling and stirred 15 minutes, the cooling medicinal liquid is to 40-50 ℃;
(2) in cooled medicinal liquid, add antibacterial, the after-filtration that stirs must be filtrated;
(3) in filtrating, add to the full amount of water for injection, utilize the pH value regulator to regulate pH value and be 6.9-7.2, return through microfilter and filter to medicinal liquid clear and brightly, passed examination promptly gets said Timolol maleate eye drops.
The aperture of said microfilter is 0.22 μ m.
The specific embodiment
Through specific embodiment the present invention is described further below:
Embodiment:
A kind of Timolol maleate eye drops, its preparation method may further comprise the steps:
(1) get timolol maleate 3.42g and glycerol 10ml, sodium hydrogen phosphate 8.95g, sodium dihydrogen phosphate 1.30g with the dissolving of 100ml water for injection, medicinal liquid, medicinal liquid is heated to boiling and stirred 15 minutes, the cooling medicinal liquid is to 40-50 ℃;
(2) in cooled medicinal liquid, add benzalkonium bromide 1ml, the after-filtration that stirs must be filtrated;
(3) in filtrating, add the injection water to 1000ml; Utilize pH value regulator sodium hydrogen phosphate, sodium dihydrogen phosphate to regulate pH value and be 6.9-7.2; Via hole diameter is that the microfilter of 0.22 μ m returns and filters to medicinal liquid clear and brightly again, and passed examination promptly gets said Timolol maleate eye drops.
Above-described is a kind of embodiment of the present invention.Among this embodiment; The pH value regulator also can be borate buffer solution; Antibacterial also can be selected any in benzalkonium chloride, hibitane, methyl hydroxybenzoate, propyl hydroxybenzoate, benzoic acid, the sodium benzoate, and the Timolol maleate eye drops that makes all has the characteristics of good stability.
Should be pointed out that for the person of ordinary skill of the art under the prerequisite that does not break away from the principle of the invention, can also make conspicuous some conversion or alternative and remodeling, these also should be regarded as belonging to protection scope of the present invention.
Claims (7)
1. a Timolol maleate eye drops comprises timolol maleate, isotonic agent, thickening agent, stabilizing agent.
2. a kind of Timolol maleate eye drops according to claim 1 is characterized in that: said isotonic agent, thickening agent, stabilizing agent are glycerol.
3. a kind of Timolol maleate eye drops according to claim 1 and 2 is characterized in that: also comprise pH value regulator, antibacterial, water for injection.
4. a kind of Timolol maleate eye drops according to claim 3 is characterized in that: said pH value regulator is phosphate buffer or borate buffer solution.
5. a kind of Timolol maleate eye drops according to claim 3 is characterized in that: said antibacterial is any in benzalkonium chloride, benzalkonium bromide, hibitane, methyl hydroxybenzoate, propyl hydroxybenzoate, benzoic acid, the sodium benzoate.
6. according to the method for preparing of the arbitrary described a kind of Timolol maleate eye drops of claim 1 to 5, may further comprise the steps:
(1) get timolol maleate and glycerol, sodium hydrogen phosphate, sodium dihydrogen phosphate dissolves with proper amount of water for injection, medicinal liquid, medicinal liquid is heated to boiling and stirred 15 minutes, the cooling medicinal liquid is to 40-50 ℃;
(2) in cooled medicinal liquid, add antibacterial, the after-filtration that stirs must be filtrated;
(3) in filtrating, add to the full amount of water for injection, utilize the pH value regulator to regulate pH value and be 6.9-7.2, return through microfilter and filter to medicinal liquid clear and brightly, passed examination promptly gets said Timolol maleate eye drops.
7. the method for preparing of a kind of Timolol maleate eye drops according to claim 6, it is characterized in that: the aperture of said microfilter is 0.22 μ m.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2012102676058A CN102743335A (en) | 2012-07-30 | 2012-07-30 | Timolol hydrogenmaleate eye drops and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2012102676058A CN102743335A (en) | 2012-07-30 | 2012-07-30 | Timolol hydrogenmaleate eye drops and preparation method thereof |
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| CN102743335A true CN102743335A (en) | 2012-10-24 |
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| CN2012102676058A Pending CN102743335A (en) | 2012-07-30 | 2012-07-30 | Timolol hydrogenmaleate eye drops and preparation method thereof |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103040837A (en) * | 2013-01-13 | 2013-04-17 | 广东宏盈科技有限公司 | Ophthalmologic intraocular pressure reduction drug for external use |
| CN105106105A (en) * | 2015-08-14 | 2015-12-02 | 天津市聚星康华医药科技有限公司 | Application of external timolol preparations in treating infantile hemangioma and preparation method thereof |
| CN112451478A (en) * | 2020-11-26 | 2021-03-09 | 江苏远恒药业有限公司 | Timolol maleate eye drops and preparation process thereof |
| CN116687844A (en) * | 2023-05-25 | 2023-09-05 | 广州大陌医药科技有限公司 | Dextromethorphan maleate eye drops and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101474146A (en) * | 2009-01-06 | 2009-07-08 | 河北科技大学 | Timolol maleate eye drops without bacteriostatic agent and preparation method thereof |
-
2012
- 2012-07-30 CN CN2012102676058A patent/CN102743335A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101474146A (en) * | 2009-01-06 | 2009-07-08 | 河北科技大学 | Timolol maleate eye drops without bacteriostatic agent and preparation method thereof |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103040837A (en) * | 2013-01-13 | 2013-04-17 | 广东宏盈科技有限公司 | Ophthalmologic intraocular pressure reduction drug for external use |
| CN105106105A (en) * | 2015-08-14 | 2015-12-02 | 天津市聚星康华医药科技有限公司 | Application of external timolol preparations in treating infantile hemangioma and preparation method thereof |
| CN112451478A (en) * | 2020-11-26 | 2021-03-09 | 江苏远恒药业有限公司 | Timolol maleate eye drops and preparation process thereof |
| CN116687844A (en) * | 2023-05-25 | 2023-09-05 | 广州大陌医药科技有限公司 | Dextromethorphan maleate eye drops and preparation method thereof |
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Application publication date: 20121024 |