CN105106105A - Application of external timolol preparations in treating infantile hemangioma and preparation method thereof - Google Patents
Application of external timolol preparations in treating infantile hemangioma and preparation method thereof Download PDFInfo
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- CN105106105A CN105106105A CN201510497475.0A CN201510497475A CN105106105A CN 105106105 A CN105106105 A CN 105106105A CN 201510497475 A CN201510497475 A CN 201510497475A CN 105106105 A CN105106105 A CN 105106105A
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- timolol
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- timolol maleate
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Abstract
The invention discloses application of external timolol preparations in treating infantile hemangioma and a preparation method thereof, belongs to the field of pharmacy and aims to providing various timolol preparations supportive of external use and used for treating infantile hemangioma. Various external preparations like gels, plastics, paste and pigmentum can be prepared by adding proper auxiliary materials like gel substrate, percutaneous penetration enhancer, preservative, humectant, emulsifier, film forming material and oily substrate. The external timolol preparations have the advantages of high safety, accurate curative effect, high tolerance and quickness in taking effect.
Description
Technical field
The invention belongs to pharmaceutical field, relate to timolol external preparation and preparation method thereof.
Background technology
Hemangioma is one of modal benign lesion of infant, and its sickness rate is 8.7% ~ 12.7%, and in premature infant or low birth weight infant, its prevalence can up to 22%, and wherein the hemangioma of about 60% occurs in incidence.Most hemangioma has self limiting, can disappear gradually along with the increase at age; But there are some angiomatous development may have a negative impact to life, organ-tissue and function, at this moment just need to carry out suitable treatment.The angiomatous method of current treatment comprises medicine, operation, laser and radiation etc.
After reported first in 2008 uses propranolol in treatment infant hemangioma to obtain better curative effect, domestic and international researcher more and more pays close attention to the efficacy and saferry of beta-blocker in treatment infant hemangioma, and find that external Timolol maleate eye drops is coated affected area and also can be obtained good therapeutic effect, and safety is better.
The chemical name of timolol maleate is that the tertiary fourth of (-)-1-(is amino)-3-[(4-morpholinyl-1,2,5-thiadiazoles-3-base) oxygen]-2-propanol maleate, molecular formula is C
13h
24n
4o
3sC
4h
4o
4, basic physical and chemical comprises: my white crystalline powder of this product; Odorless, bitter in the mouth.This product is dissolved in water or methanol, slightly molten in ethanol, and slightly soluble in chloroform is almost insoluble in cyclohexane extraction or ether.It is a kind of Nonselective beta-blockers, without membrane stabilizing action and endogenous sympathomimetic activity.Its possible mechanism of action being applied to treatment infant hemangioma comprises: (1) local vascular kinetic effect (vasoconstriction, the result that a kind of beta-adrenergic blocking agent of classics and IH pathological changes reduce); (2) by the impact on path, blood vessel formation against function is played; (3) the apoptosis effect of capillary endothelial cells is triggered.
The object of this invention is to provide a kind of timolol preparation for local, having the features such as the high and onset of determined curative effect, safety is rapid, is the new selection for the treatment of infant hemangioma.
Summary of the invention
The object of the present invention is to provide a kind of timolol external preparation that can be used for treating infant hemangioma.
Be used for the treatment of the timolol external preparation of infant hemangioma, it is characterized in that: in preparation, the content of timolol is 0.05% ~ 2%.Wherein, described timolol can be active component itself, also can be its pharmaceutically acceptable salt, wherein preferred timolol maleate.In preferred formulation, the content of timolol maleate is 0.1% ~ 2%.
Timolol maleate exterior-applied gel, is characterized in that consisting of the following composition:
Wherein, described gel-type vehicle can be selected from one or more in sodium carboxymethyl cellulose, carbomer, methylcellulose, polyvinyl alcohol; Described percutaneous penetrating agent can be selected from one or more in Oleum menthae, farnesol and glycyrrhizic acid dipotassium; Described wetting agent can be selected from glycerol and propylene glycol; Described antiseptic can be selected from sorbic acid and ethyl hydroxybenzoate.
Timolol maleate liniment, is characterized in that mainly consisting of the following composition:
Wherein, described filmogen can be selected from one or more combinations in ethyl cellulose, ethylene-vinyl acetate copolymer and polyvinylpyrrolidone; Described percutaneous penetrating agent can be selected from one or more combinations of lauryl alcohol and azone; Described plasticizer can be selected from one or more combinations of glycerol and propylene glycol; Described organic solvent is ethanol.
Timolol maleate ointment, is characterized in that consisting of the following composition:
Wherein, described oleaginous base can be selected from one or more in stearic acid, paraffin, vaseline, liquid paraffin, octadecanol; Described percutaneous penetrating agent can be selected from lauryl alcohol or azone; Described wetting agent can be selected from the one or both combination in glycerol and propylene glycol; Described emulsifying agent can be selected from sodium lauryl sulphate, Polysorbate and glyceryl monostearate; Described antiseptic can be selected from ethyl hydroxybenzoate and ethyl hydroxybenzoate.
Timolol maleate varnish, is characterized in that consisting of the following composition:
Wherein, described pH adjusting agent can be selected from one or more in sodium hydrogen phosphate, sodium dihydrogen phosphate, sodium chloride; Described stabilizing agent is sodium sulfite; Described thickening agent is glycerol.
The timolol external preparation prepared according to the present invention has the high and advantage such as rapid-action of determined curative effect, safety, is very applicable to clinical practice.
Detailed description of the invention
The present invention is further elaborated by following examples, but scope of the present invention is not limited to these embodiments.So, under method prerequisite of the present invention, all the scope of protection of present invention is belonged to simple modifications of the present invention.
the preparation method of described gel:
Preparation technology is substantially identical: take supplementary material by prescription.Gel-type vehicle being added suitable quantity of water stirs swelling, after raw material, wetting agent being dissolved, is added in swelling substrate completely, adds the alcoholic solution being dissolved with antiseptic, percutaneous penetrating agent, and add enough water and stir
embodiment 1
Prescription (by 100g): timolol maleate 0.5g, sodium carboxymethyl cellulose 2g, farnesol 1g, propylene glycol 12g, ethyl hydroxybenzoate 1g, appropriate amount of ethanol, all the other are water.
embodiment 2
Prescription (by 100g): timolol maleate 1g, carbomer 3g, Oleum menthae 2g, glycerol 8g, sorbic acid 0.5g, appropriate amount of ethanol, all the other are water.
embodiment 3
Prescription (by 100g): timolol maleate 2g, polyvinyl alcohol 2g, methylcellulose 1g, glycyrrhizic acid dipotassium 2.5g, glycerol 10g, ethyl hydroxybenzoate 1g, appropriate amount of ethanol, all the other are water.
The gel character prepared by embodiment 1 ~ 3 is homogeneous, and has certain viscosity.
the preparation method of described liniment:
Preparation technology is substantially identical: take supplementary material by prescription.Filmogen is added water swelling, can suitably heat in this process; Until swelling completely after, plasticizer is joined in gel and goes; After timolol maleate, transdermal enhancer are added organic solvent dissolution, in the gel that before being joined by solution, step obtains, and add enough organic solvent mix homogeneously.
embodiment 4
Prescription (by 100ml): timolol maleate 0.5g, polyvinylpyrrolidone 10g, lauryl alcohol 2g, glycerol 5g, add ethanol to 100ml.
embodiment 5
Prescription (by 100ml): timolol maleate 1g, ethylene-vinyl acetate copolymer 5g, azone 5g, propylene glycol 5g, add ethanol to 100ml.
embodiment 6
Prescription (by 100ml): timolol maleate 2g, ethyl cellulose 8g, lauryl alcohol 5g, glycerol 10g, add ethanol to 100ml.
The liniment outward appearance clarification prepared by embodiment 4 ~ 6, after coating skin surface, organic solvent can volatilize in 1 minute, formed thin film and was coated on skin surface.
the preparation method of described ointment:
Preparation technology is substantially identical: take supplementary material by prescription.Oil phase substrate is mixed and heated to molten condition, and temperature controls at 80 DEG C.Aqueous phase substrate is dissolved in suitable quantity of water, after it dissolves completely, is joined by oil phase in aqueous phase, stirs, is cooled to room temperature.
embodiment 7
Prescription (by 100g): timolol maleate 0.5g, octadecanol 6.5g, glyceryl monostearate 6.5g, stearic acid 6.5g, liquid paraffin 9g, propylene glycol 9g, sodium lauryl sulphate 2g, azone 0.5g, ethyl hydroxybenzoate 0.1g, all the other are water.
embodiment 8
Prescription (by 100g): timolol maleate 1g, paraffin 10g, stearic acid 6.5g, liquid paraffin 12g, glycerol 10g, Polysorbate 1.5g, lauryl alcohol 0.5g, ethyl hydroxybenzoate 0.2g, all the other are water.
embodiment 9
Prescription (by 100g): timolol maleate 2g, glyceryl monostearate 7g, stearic acid 10g, vaseline 12g, liquid paraffin 10g, glycerol 12g, sodium lauryl sulphate 1g, ethyl hydroxybenzoate 0.1g, all the other are water.
The ointment prepared by embodiment 7 ~ 9 all can keep character homogeneous, and viscosity is moderate.
the preparation method of described varnish:
Preparation technology is substantially identical: take supplementary material by prescription.Supplementary material suitable quantity of water dissolved, add water after stirring standardize solution, subpackage after filtering with microporous membrane.
embodiment 10
Prescription (by 100ml): timolol maleate 0.5g, sodium dihydrogen phosphate 0.62g, sodium hydrogen phosphate 0.2g, glycerol 1g, adds water to 100ml.
embodiment 11
Prescription (by 100ml): timolol maleate 1g, sodium dihydrogen phosphate 0.48g, sodium hydrogen phosphate 0.37g, sodium sulfite 0.2g, adds water to 100ml.
embodiment 12
Prescription (by 100ml): timolol maleate 2g, sodium hydrogen phosphate 0.1g, sodium chloride 0.7g, adds water to 100ml.
The varnish prepared by embodiment 10 ~ 12 is settled solution.
The timolol maleate external preparation prepared by embodiment 1,4,7,10 is applied to respectively the infant affected area of age in 0-2 year that 3 examples suffer from facial hemangioma, once a day, effect is more satisfactory, and does not find serious adverse reaction, and medication compliance improves greatly.The situation of change of the target blood tumor of infant is as shown in table 1-4.
The effect of Timoptic-XE prepared by table 1 embodiment 1
The effect of timolol maleate liniment prepared by table 2 embodiment 4
The effect of timolol maleate emulsifiable paste prepared by table 3 embodiment 7
The effect of timolol maleate varnish prepared by table 4 embodiment 10
Claims (7)
1. be used for the treatment of the timolol external preparation of infant hemangioma, it is characterized in that: in preparation, the content of timolol is 0.05% ~ 2%.
2. timolol external preparation according to claim 1, is characterized in that: described timolol can be active component itself, also can be its pharmaceutically acceptable salt, wherein preferred timolol maleate.
3., according to claim 1 and timolol external preparation according to claim 2, it is characterized in that: in preparation, the content of timolol maleate is preferably 0.1% ~ 2%.
4. timolol maleate exterior-applied gel according to claim 3, is characterized in that consisting of the following composition:
Wherein, described gel-type vehicle can be selected from one or more in sodium carboxymethyl cellulose, carbomer, methylcellulose, polyvinyl alcohol; Described percutaneous penetrating agent can be selected from one or more in Oleum menthae, farnesol and glycyrrhizic acid dipotassium; Described wetting agent can be selected from glycerol and propylene glycol; Described antiseptic can be selected from sorbic acid and ethyl hydroxybenzoate.
5. timolol maleate liniment according to claim 3, is characterized in that mainly consisting of the following composition:
Wherein, described filmogen can be selected from one or more combinations in ethyl cellulose, ethylene-vinyl acetate copolymer and polyvinylpyrrolidone; Described percutaneous penetrating agent can be selected from one or more combinations of lauryl alcohol and azone; Described plasticizer can be selected from one or more combinations of glycerol and propylene glycol; Described organic solvent is ethanol.
6. timolol maleate ointment according to claim 3, is characterized in that consisting of the following composition:
Wherein, described oleaginous base can be selected from one or more in stearic acid, paraffin, vaseline, liquid paraffin, octadecanol; Described percutaneous penetrating agent can be selected from lauryl alcohol or azone; Described wetting agent can be selected from the one or both combination in glycerol and propylene glycol; Described emulsifying agent can be selected from sodium lauryl sulphate, Polysorbate and glyceryl monostearate; Described antiseptic can be selected from ethyl hydroxybenzoate and ethyl hydroxybenzoate.
7. timolol maleate varnish according to claim 3, is characterized in that consisting of the following composition:
Wherein, described pH adjusting agent can be selected from one or more in sodium hydrogen phosphate, sodium dihydrogen phosphate, sodium chloride; Described stabilizing agent is sodium sulfite; Described thickening agent is glycerol.
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Cited By (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105998178A (en) * | 2016-05-06 | 2016-10-12 | 中国人民解放军第四军医大学 | Timolol external preparation for treating hemangioma |
| CN106176758A (en) * | 2016-06-17 | 2016-12-07 | 北京梅尔森医药技术开发有限公司 | A kind of externally-applied medicinal composition |
| CN106729614A (en) * | 2016-10-27 | 2017-05-31 | 刘腾 | A kind of preparation method for treating the ointment of infant hemangioma |
| CN106727278A (en) * | 2016-10-10 | 2017-05-31 | 北京梅尔森医药技术开发有限公司 | A kind of Timoptic-XE agent and preparation method thereof |
| CN107281094A (en) * | 2017-06-14 | 2017-10-24 | 上海奥科达生物医药科技有限公司 | A kind of timolol maleate Pharmaceutical composition and preparation method thereof |
| CN110755367A (en) * | 2019-10-11 | 2020-02-07 | 郑州儿童医院 | Hemangioma gel containing amphiphilic polymer and preparation method thereof |
| CN111067905A (en) * | 2020-01-15 | 2020-04-28 | 广州阿拉金医药科技有限公司 | Timolol or its salt composition, its hydrogel emplastrum and application for treating hemangioma |
| CN111374937A (en) * | 2019-10-11 | 2020-07-07 | 郑州儿童医院 | Gel for infantile hemangioma and preparation method thereof |
| CN112439071A (en) * | 2019-09-04 | 2021-03-05 | 武汉科福新药有限责任公司 | Transdermal penetration-promoting composition and application thereof in timolol preparation |
| CN112933096A (en) * | 2019-12-11 | 2021-06-11 | 中国科学院上海药物研究所 | Use of butyryl timolol in preparation of medicine for treating superficial, mixed or deep hemangioma |
| CN113244171A (en) * | 2021-01-28 | 2021-08-13 | 周斌 | Timolol maleate liposome gel and preparation method thereof |
| CN113559057A (en) * | 2021-08-16 | 2021-10-29 | 江苏苏赋科技发展有限公司 | Timolol maleate gel and preparation method thereof |
| CN115252718A (en) * | 2021-04-30 | 2022-11-01 | 武汉科福新药有限责任公司 | Transdermal patch containing timolol and preparation method thereof |
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Cited By (24)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105998178A (en) * | 2016-05-06 | 2016-10-12 | 中国人民解放军第四军医大学 | Timolol external preparation for treating hemangioma |
| CN106176758B (en) * | 2016-06-17 | 2019-07-23 | 北京梅尔森医药技术开发有限公司 | A kind of externally-applied medicinal composition |
| CN106176758A (en) * | 2016-06-17 | 2016-12-07 | 北京梅尔森医药技术开发有限公司 | A kind of externally-applied medicinal composition |
| CN106727278A (en) * | 2016-10-10 | 2017-05-31 | 北京梅尔森医药技术开发有限公司 | A kind of Timoptic-XE agent and preparation method thereof |
| CN106729614A (en) * | 2016-10-27 | 2017-05-31 | 刘腾 | A kind of preparation method for treating the ointment of infant hemangioma |
| CN107281094A (en) * | 2017-06-14 | 2017-10-24 | 上海奥科达生物医药科技有限公司 | A kind of timolol maleate Pharmaceutical composition and preparation method thereof |
| CN107281094B (en) * | 2017-06-14 | 2018-05-15 | 上海奥科达生物医药科技有限公司 | A kind of timolol maleate Pharmaceutical composition and preparation method thereof |
| JP2022547148A (en) * | 2019-09-04 | 2022-11-10 | 武▲漢▼科福新▲薬▼有限責任公司 | Transdermal Penetration Enhancer Compositions and Their Application in Timolol Formulations |
| GB2621775B (en) * | 2019-09-04 | 2024-05-15 | Wuhan Conform Pharmaceutical Co Ltd | Transdermal permeation enhancing composition and application thereof in timolol preparation |
| GB2600633B (en) * | 2019-09-04 | 2024-04-03 | Wuhan Conform Pharmaceutical Co Ltd | Transdermal permeation enhancing composition and application thereof in timolol preparation |
| GB2621775A (en) * | 2019-09-04 | 2024-02-21 | Wuhan Conform Pharmaceutical Co Ltd | Transdermal permeation enhancing composition and application thereof in timolol preparation |
| CN112439071A (en) * | 2019-09-04 | 2021-03-05 | 武汉科福新药有限责任公司 | Transdermal penetration-promoting composition and application thereof in timolol preparation |
| JP7369278B2 (en) | 2019-09-04 | 2023-10-25 | 武▲漢▼科福新▲薬▼有限責任公司 | Transdermal penetration promoting composition and its application in timolol formulations |
| EP4026565A4 (en) * | 2019-09-04 | 2023-03-15 | Wuhan Conform Pharmaceutical Co., Ltd. | Transdermal penetration enhancing composition and application thereof in timolol preparation |
| CN112439071B (en) * | 2019-09-04 | 2022-05-20 | 武汉科福新药有限责任公司 | Transdermal penetration-promoting composition and application thereof in timolol preparation |
| CN111374937B (en) * | 2019-10-11 | 2023-04-18 | 郑州儿童医院 | Gel for infantile hemangioma and preparation method thereof |
| CN111374937A (en) * | 2019-10-11 | 2020-07-07 | 郑州儿童医院 | Gel for infantile hemangioma and preparation method thereof |
| CN110755367A (en) * | 2019-10-11 | 2020-02-07 | 郑州儿童医院 | Hemangioma gel containing amphiphilic polymer and preparation method thereof |
| CN112933096B (en) * | 2019-12-11 | 2023-06-13 | 中国科学院上海药物研究所 | Use of Ding Xiansai molol in preparing medicament for treating shallow phenotype, mixed or deep hemangioma |
| CN112933096A (en) * | 2019-12-11 | 2021-06-11 | 中国科学院上海药物研究所 | Use of butyryl timolol in preparation of medicine for treating superficial, mixed or deep hemangioma |
| CN111067905A (en) * | 2020-01-15 | 2020-04-28 | 广州阿拉金医药科技有限公司 | Timolol or its salt composition, its hydrogel emplastrum and application for treating hemangioma |
| CN113244171A (en) * | 2021-01-28 | 2021-08-13 | 周斌 | Timolol maleate liposome gel and preparation method thereof |
| CN115252718A (en) * | 2021-04-30 | 2022-11-01 | 武汉科福新药有限责任公司 | Transdermal patch containing timolol and preparation method thereof |
| CN113559057A (en) * | 2021-08-16 | 2021-10-29 | 江苏苏赋科技发展有限公司 | Timolol maleate gel and preparation method thereof |
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Application publication date: 20151202 |