CN104940172A - Melatonin-containing transdermal patch and preparation method thereof - Google Patents
Melatonin-containing transdermal patch and preparation method thereof Download PDFInfo
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- CN104940172A CN104940172A CN201510333583.4A CN201510333583A CN104940172A CN 104940172 A CN104940172 A CN 104940172A CN 201510333583 A CN201510333583 A CN 201510333583A CN 104940172 A CN104940172 A CN 104940172A
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- melatonin
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Abstract
The invention relates to the technical field of transdermal patches, in particular to a melatonin-containing transdermal patch and a preparation method thereof. The transdermal patch comprises a substrate, a melatonin-containing adhesive and an anti-sticking protective film, wherein the melatonin-containing adhesive is a pressure-sensitive adhesive; the melatonin content in the melatonin-containing adhesive is 1-20%. Through the adoption of the melatonin-containing transdermal patch, a user can fall asleep rapidly, the sleeping quality is improved, the immunity is enhanced, and the ageing process is delayed; medicine in the melatonin-containing transdermal patch is applied in a transdermal manner, so that the irritation to a digestive tract and the side effects caused by oral medicine application are avoided, and the use can be safer and more convenient.
Description
Technical field
The present invention relates to percutaneous plaster technical field, be specifically related to a kind of percutaneous plaster containing melatonin and preparation method thereof.
Background technology
Melatonin is a kind of indole hormone be secreted by humans and animals pinus, there is physiologically active widely, can control to coordinate human immune system, nervous system, hormonal system, reproductive system, there is antitonic, lipoid peroxidization resistant, participate in the activities such as calmness, hypnosis, analgesia and interest-free effect.Be widely used as defying age, enhancing immunity, angiocardiopathy preventing, cancer and various infirmities of age at home and abroad, maintain the health product of normal sexual function, improving water flood.
The biosynthesis of melatonin is by photoperiodic restriction.Pinus, under the control of light nerve, changes into 5-hydroxyryptophan by tryptophan transfer, changes into 5-hydroxy tryptamine further; under the effect of N-acetyltransferase; change into N-acetyl-5-hydroxytryptamine again, finally synthesize melatonin, thus content in the body rhythm and pace of moving things in property is round the clock changed.Night melatonin secretion amount than daytime more 5-10 doubly, 2 o'clock early mornings reached peak value by 3 o'clock, and Hakola etc., to the result of study of melatonin content in night shift's saliva, also demonstrate that this daily rhythmicity changes; Melatonin biosynthesis also has much relations with the age, and it can enter in fetus body by Placenta Hominis, also can authorize neonate through suckling.Therefore, also the melatonin of seldom amount can be detected in the infants of just birth, until three time-division at the monthly age amounts of secreting just increase, and present obvious Circadian Rhythm, the melatonin secretion amount at night of 3 ~ 5 years old childs is the highest, adolescence secretory volume slightly declines, and increases later and decline gradually along with the age.
With advancing age, the melatonin of body self secretion interior obviously declines, and on average within every 10 years, reduce 10-15%, cause sleep disordered and a series of functional disorder, and melatonin levels reduces, sleep minimizing is one of important symbol of mankind's brain aging.Therefore, from external supplementary melatonin, the melatonin levels in body can be made to maintain younger state, adjustment and recovery circadian rhythm, can not only add deep sleep, improve sleep quality, the more important thing is the functional status improving whole health, improve the quality of living, the process of slow down aging, reduces glucocorticoid.
Oral melatonin launch existing a large amount of at present, as melatonin etc., it regulates function of human body, the obvious effect of improving water flood quality gains universal acceptance.But the dosage form of current melatonin product is single, is generally oral liquid or oral tablet.Oral melatonin is easy to produce side effect such as having a headache, gastrointestinal tract is uncomfortable, therefore, needs to increase different dosage forms and different route of administration, to meet the different demands of consumer, overcomes the issuable side effect of oral formulations.
Summary of the invention
The object of this invention is to provide a kind of percutaneous plaster containing melatonin and preparation method thereof, user should can be impelled to fall asleep fast, improved sleep quality, enhancing immunity, slow down aging containing the percutaneous plaster of melatonin, and administering mode is administration through skin, do not stimulate digestion, avoid the side effect of oral administration, it is safer, convenient to use.
In order to realize above object, the present invention adopts following technical scheme:
Containing the percutaneous plaster of melatonin, described percutaneous plaster is by substrate, form containing the colloid of melatonin and antiseized protecting film, and the described colloid containing melatonin adopts pressure sensitive adhesive, and in described colloid, the content of melatonin is 1-20%.
Described substrate adopts plastic foil or the fibrous membrane of flexible, breathable, and described antiseized protecting film adopts has plastic foil or the paper film that certain degree of hardness and toughness, surface have anti-stick coating.
Preferably, described substrate adopts eva film, polyurethane film or non-woven fabrics, and described antiseized protecting film adopts PET film, release paper or the aluminium foil with anti-stick coating.
Preferably, described pressure sensitive adhesive is polyacrylic, silica type or rubber-like pressure sensitive adhesive.
Preferably, also penetrating agent and/or anti-allergic agent is contained in described colloid.
Preferably, described penetrating agent is azone, plants essential oil or oleic acid, and described anti-allergic agent is bisabolol.
Preferably, described plants essential oil is Herba Lysimachiae foenum-graeci quintessence oil.
Preferably, described colloid is composed as follows by weight percentage: pressure sensitive adhesive 78-95%, melatonin 1-20%, penetrating agent 0.5-5%.
The preparation method of the above-mentioned percutaneous plaster containing melatonin, is characterized in that, comprise the following steps:
(1) prepare burden: take pressure sensitive adhesive, melatonin or pressure sensitive adhesive, melatonin, penetrating agent and/or anti-allergic agent by formula;
(2) mix: the material weighed up to be poured in container and to stir;
(3) be coated with: the rubber cement that step (2) mixes is uniformly coated on substrate, and dry at 50 DEG C ~ 200 DEG C;
(4) laminating: by laminating for the adhesive surface of the colloid face of substrate after coating rubber cement and antiseized protecting film;
(5) cross cutting: by specification requirement shape by die-cutting.
The using method of described percutaneous plaster is: percutaneous plaster is cut into a certain size, throws off protecting film during use, is close on skin in the colloid face exposed.
Above-mentioned raw materials can also be prepared into the paster of lasting 24 hours release melatonin by the present invention, is exclusively used in the health care such as enhancing immunity, slow down aging.
Percutaneous plaster containing melatonin provided by the invention, by the substrate of flexible, breathable, containing colloid and the superimposed composition of antiseized protecting film of melatonin, antiseized protecting film is thrown off during use, the melatonin colloid that contains investing substrate is closely affixed on human skin, namely this paster can pass through skin continues to provide melatonin to human body, user can be impelled to fall asleep fast, improve sleep quality, enhancing immunity, slow down aging, and administering mode is administration through skin, avoid the more issuable side effect of oral melatonin and inconvenience, do not stimulate digestion, avoid the side effect of oral administration, use safer, convenient.
After percutaneous plaster containing melatonin provided by the invention is affixed on human body skin, continual and steady release melatonin 6 hours, to ensure the length of one's sleep, improves sleep quality, overcomes traditional oral preparation hypnotic short for action time, be easy to the defect of early awakening.This percutaneous plaster pastes and reduces rapidly by release amount after 6 hours; be convenient to paste user naturally wake up, paste with 8 hours afterwards to 24 hours, the still a small amount of melatonin of sustainable release; when not affecting user normal activity, its enhancing immunity, anti-ageing effect of waiting for a long time can be played.
Accompanying drawing explanation
Fig. 1 is the structural representation of the percutaneous plaster containing melatonin that the embodiment of the present invention 1 provides;
Fig. 2 is the rat skin in vitro drug release profiles containing the different prescription of melatonin percutaneous plaster described in the embodiment of the present invention 1,4,5,6,7,8;
Fig. 3 be described in the embodiment of the present invention 1 and 2 two kinds be respectively used to hypnotic and slow down aging containing the drug release profiles of melatonin percutaneous plaster in rat skin in vitro.
Detailed description of the invention
Embodiment 1
As shown in Figure 1; a kind of percutaneous plaster containing melatonin; described percutaneous plaster is by substrate 1, form containing the colloid 2 of melatonin and antiseized protecting film 3; described substrate employing thickness is the polyurethane film of 30 microns; antiseized protecting film adopts the PET film of 75 micron thickness; colloid adopts polyacrylic pressure sensitive adhesive to be substrate, and described colloid is composed as follows by mass percentage:
Polyacrylic acid pressure sensitive adhesive 82%, melatonin 15%, azone 3% (penetrating agent).
The using method of described percutaneous plaster is: percutaneous plaster is cut into a certain size, throws off protecting film during use, is close on skin in the colloid face exposed.
The preparation method of the above-mentioned percutaneous plaster containing melatonin comprises the following steps:
(1) prepare burden: take pressure sensitive adhesive, melatonin by weight percentage;
(2) mix: the material weighed up to be poured in container and to stir with high speed dispersor;
(3) be coated with: the rubber cement that step (2) mixes is uniformly coated on substrate, and dry at 140-150 DEG C;
(4) laminating: by laminating for the adhesive surface of the colloid face of substrate after coating rubber cement and antiseized protecting film;
(5) cross cutting: prepare mold cutter by specification requirement, uses die-cutting machine shape by die-cutting.
The percutaneous plaster prepared being cut into area is 5.5cm
2rounded square paster, every sheet containing melatonin 5mg, is used for the treatment of insomnia.This paster can quick acting and in 6 hours sustained release melatonin be about 3mg (relative amount about 60%), then reduce rate of release, be convenient to nature and wake up.
Embodiment 2
Containing a percutaneous plaster for melatonin, its substrate employing thickness is the EVA film of 30 microns, and antiseized protecting film adopts the PET film of 75 micron thickness, and colloid adopts polyacrylic pressure sensitive adhesive to be substrate, and described colloid is composed as follows by mass percentage:
Polyacrylic acid pressure sensitive adhesive 91%, melatonin 8%, oleic acid 1% (penetrating agent).
Above-mentioned containing in the percutaneous plaster its preparation method of melatonin, step (3) bake out temperature is 150-160 DEG C, and all the other are with embodiment 1.
The percutaneous plaster prepared is cut into the rounded square paster that area is 5.5cm2, every sheet, containing melatonin 3mg, is applicable to enhancing immunity, slow down aging.Paste and discharged melatonin continually and steadily in latter 24 hours.
Embodiment 3
Containing a percutaneous plaster for melatonin, its substrate employing thickness is the EVA film of 30 microns, and antiseized protecting film adopts the PET film of 75 micron thickness, and colloid adopts polyacrylic pressure sensitive adhesive to be substrate, and described colloid is composed as follows by mass percentage:
Polyacrylic acid pressure sensitive adhesive 85%, melatonin 13%, Herba Lysimachiae foenum-graeci quintessence oil 2% (penetrating agent).
Above-mentioned containing in the percutaneous plaster its preparation method of melatonin, step (3) bake out temperature is 100-120 DEG C, and all the other are with embodiment 1.
Embodiment 4
Containing a percutaneous plaster for melatonin, in its colloid, contained penetrating agent is Herba Lysimachiae foenum-graeci quintessence oil, and degree is 3%, and all the other are with embodiment 1.
Embodiment 5
Containing a percutaneous plaster for melatonin, its colloid adopts polyacrylic pressure sensitive adhesive to be substrate, and described colloid is composed as follows by mass percentage:
Polyacrylic acid pressure sensitive adhesive 80%, melatonin 15%, oleic acid 5% (penetrating agent).
All the other are with embodiment 1.
Embodiment 6
A kind of percutaneous plaster containing melatonin; described percutaneous plaster is by substrate, form containing the colloid of melatonin and antiseized protecting film; described substrate adopts non-woven fabrics; antiseized protecting film adopts the PET film of 75 micron thickness; colloid adopts polyacrylic pressure sensitive adhesive to be substrate, and described colloid is composed as follows by mass percentage:
Polyacrylic acid pressure sensitive adhesive 87%, melatonin 10%, azone 3% (penetrating agent).
Its preparation method is with embodiment 1.
Embodiment 7
A kind of percutaneous plaster containing melatonin, colloid adopts polyacrylic pressure sensitive adhesive to be substrate, and described colloid is composed as follows by mass percentage: polyacrylic acid pressure sensitive adhesive 87%, melatonin 10%, Herba Lysimachiae foenum-graeci quintessence oil 3% (penetrating agent), all the other are with embodiment 6.
Embodiment 8
Containing a percutaneous plaster for melatonin, colloid adopts polyacrylic pressure sensitive adhesive to be substrate, and described colloid is composed as follows by mass percentage: polyacrylic acid pressure sensitive adhesive 85%, melatonin 10%, and oleic acid 5% (penetrating agent), all the other are with embodiment 6.
Different penetrating agent and the releasing medicine through skin penetration speed of different additions on melatonin is adopted to have different impacts.As shown in Figure 2:
Series 5, series 2 are respectively embodiment 5,8---containing the oleic acid of 5%;
Series 3, series 4 are respectively embodiment 4,7---containing the Herba Lysimachiae foenum-graeci quintessence oil of 3%;
Series 1, series 6 are respectively embodiment 1,6---containing the azone of 3%;
Obviously, azone has better transdermal mechanism to melatonin.
Fig. 3 be described in the embodiment of the present invention 1 and 2 two kinds be respectively used to hypnotic and slow down aging containing the drug release profiles of melatonin percutaneous plaster in rat skin in vitro.
As can be seen from Figure 3: hypnotic paste (embodiment 1), quick acting and in 6 hours sustained release melatonin be about 3mg (relative amount about 60%), then reduce burst size, be convenient to nature and wake up.
To lengthen the life subsides (embodiment 2), paste and discharge about 3mg melatonin with lasting equilibrium in latter 24 hours.
The above-mentioned description to embodiment can understand and apply this case technology for the ease of those skilled in the art, person skilled in the art obviously can make various amendment to these examples easily, and General Principle described herein is applied in other embodiment and need not through performing creative labour.Therefore, this case is not limited to above embodiment, and those skilled in the art is according to the announcement of this case, and the improvement made for this case and amendment all should in the protection domains of this case.
Claims (9)
1. containing the percutaneous plaster of melatonin, it is characterized in that, described percutaneous plaster is by substrate, form containing the colloid of melatonin and antiseized protecting film, and the described colloid containing melatonin adopts pressure sensitive adhesive, and in described colloid, the content of melatonin is 1-20%.
2. the percutaneous plaster containing melatonin according to claim 1, is characterized in that, described substrate adopts plastic foil or the fibrous membrane of flexible, breathable, and described antiseized protecting film adopts has plastic foil or the paper film that certain degree of hardness and toughness, surface have anti-stick coating.
3. the percutaneous plaster containing melatonin according to claim 1, is characterized in that, described substrate adopts eva film, polyurethane film or non-woven fabrics, and described antiseized protecting film adopts PET film, release paper or the aluminium foil with anti-stick coating.
4. the percutaneous plaster containing melatonin according to claim 1, it is characterized in that, described pressure sensitive adhesive is polyacrylic, silica type or rubber-like pressure sensitive adhesive.
5. the percutaneous plaster containing melatonin according to claim 1, is characterized in that, also containing penetrating agent and/or anti-allergic agent in described colloid.
6. the percutaneous plaster containing melatonin according to claim 5, it is characterized in that, described penetrating agent is azone, plants essential oil or oleic acid, and described anti-allergic agent is bisabolol.
7. the percutaneous plaster containing melatonin according to claim 6, it is characterized in that, described plants essential oil is Herba Lysimachiae foenum-graeci quintessence oil.
8. the percutaneous plaster containing melatonin according to claim 5, it is characterized in that, described colloid is made up of following raw material by weight percentage: pressure sensitive adhesive 78-95%, melatonin 1-20%, penetrating agent 0.5-5%.
9. a preparation method for the percutaneous plaster containing melatonin according to claim 1, is characterized in that, comprise the following steps:
(1) prepare burden: take pressure sensitive adhesive, melatonin or pressure sensitive adhesive, melatonin, penetrating agent and/or anti-allergic agent by formula;
(2) mix: the material weighed up to be poured in container and to stir;
(3) be coated with: the rubber cement that step (2) mixes is uniformly coated on substrate, and dry at 100 ~ 160 DEG C;
(4) laminating: by laminating for the adhesive surface of the colloid face of substrate after coating rubber cement and antiseized protecting film;
(5) cross cutting: by specification requirement shape by die-cutting.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510333583.4A CN104940172A (en) | 2015-06-16 | 2015-06-16 | Melatonin-containing transdermal patch and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510333583.4A CN104940172A (en) | 2015-06-16 | 2015-06-16 | Melatonin-containing transdermal patch and preparation method thereof |
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| CN104940172A true CN104940172A (en) | 2015-09-30 |
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| CN201510333583.4A Pending CN104940172A (en) | 2015-06-16 | 2015-06-16 | Melatonin-containing transdermal patch and preparation method thereof |
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105232497A (en) * | 2015-10-29 | 2016-01-13 | 嘉兴鑫稳生物科技有限公司 | Composition and preparation system of Melatonin percutaneous delivery preparation |
| CN105362254A (en) * | 2015-12-09 | 2016-03-02 | 北京邦尼康达医药科技有限公司 | Nitroglycerin adhesive patch and preparation method thereof |
| CN105687186A (en) * | 2015-12-31 | 2016-06-22 | 卢秋妤 | Sleeping medicinal preparation for external use and preparation method thereof |
| RU2611392C1 (en) * | 2016-03-14 | 2017-02-21 | Государственное бюджетное образовательное учреждение высшего профессионального образования "Южно-Уральский государственный медицинский университет" Министерства здравоохранения Российской Федерации (ГБОУ ВПО ЮУГМУ Минздрава России) | Method for correction of behavioral disorders in experimental desynchronosis under conditions of led lighting |
| CN106727511A (en) * | 2016-12-23 | 2017-05-31 | 苏州大学附属第医院 | Purposes of the epiphysin in the medicine for the treatment of loosening Periprosthetic chronic inflammation and destruction of bone is prepared |
| WO2018080214A1 (en) * | 2016-10-31 | 2018-05-03 | 신신제약 주식회사 | Percutaneous absorption formulation for treating sleep disorders |
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| JPH10182455A (en) * | 1996-12-24 | 1998-07-07 | Teisan Seiyaku Kk | Melatonin-containing plaster |
| JP2001058960A (en) * | 1999-08-19 | 2001-03-06 | Yuutoku Yakuhin Kogyo Kk | Transdermal preparation of melatonin |
| CN1744893A (en) * | 2003-01-31 | 2006-03-08 | 弗西蒂技术有限公司 | Method for treating ischemic stroke with melatonin |
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2015
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH10182455A (en) * | 1996-12-24 | 1998-07-07 | Teisan Seiyaku Kk | Melatonin-containing plaster |
| JP2001058960A (en) * | 1999-08-19 | 2001-03-06 | Yuutoku Yakuhin Kogyo Kk | Transdermal preparation of melatonin |
| CN1744893A (en) * | 2003-01-31 | 2006-03-08 | 弗西蒂技术有限公司 | Method for treating ischemic stroke with melatonin |
Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105232497A (en) * | 2015-10-29 | 2016-01-13 | 嘉兴鑫稳生物科技有限公司 | Composition and preparation system of Melatonin percutaneous delivery preparation |
| CN105362254A (en) * | 2015-12-09 | 2016-03-02 | 北京邦尼康达医药科技有限公司 | Nitroglycerin adhesive patch and preparation method thereof |
| CN105687186A (en) * | 2015-12-31 | 2016-06-22 | 卢秋妤 | Sleeping medicinal preparation for external use and preparation method thereof |
| RU2611392C1 (en) * | 2016-03-14 | 2017-02-21 | Государственное бюджетное образовательное учреждение высшего профессионального образования "Южно-Уральский государственный медицинский университет" Министерства здравоохранения Российской Федерации (ГБОУ ВПО ЮУГМУ Минздрава России) | Method for correction of behavioral disorders in experimental desynchronosis under conditions of led lighting |
| WO2018080214A1 (en) * | 2016-10-31 | 2018-05-03 | 신신제약 주식회사 | Percutaneous absorption formulation for treating sleep disorders |
| CN106727511A (en) * | 2016-12-23 | 2017-05-31 | 苏州大学附属第医院 | Purposes of the epiphysin in the medicine for the treatment of loosening Periprosthetic chronic inflammation and destruction of bone is prepared |
| CN106727511B (en) * | 2016-12-23 | 2019-09-06 | 苏州大学附属第一医院 | Epiphysin treats the purposes in the drug for loosening Periprosthetic chronic inflammation and destruction of bone in preparation |
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Application publication date: 20150930 |