CN103976983A - Angelica oil transdermal patch and preparation method thereof - Google Patents
Angelica oil transdermal patch and preparation method thereof Download PDFInfo
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- CN103976983A CN103976983A CN201410241605.XA CN201410241605A CN103976983A CN 103976983 A CN103976983 A CN 103976983A CN 201410241605 A CN201410241605 A CN 201410241605A CN 103976983 A CN103976983 A CN 103976983A
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- angelicae sinensis
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Abstract
The invention discloses an angelica oil transdermal patch and a preparation method thereof, which provides a modern TTS (transdermal thrapeutic system) traditional Chinese medicinal preparation to broad women suffering from dysmenorrhea. The patch is characterized in that: angelica oil serving as a raw material and polyethylene glycol serving as a matrix are encapsulated between a lining membrane and a controlled-release membrane to prepare the membrane-controlled transdermal patch for treatment of dysmenorrhea. The patch can release drugs at a constant speed, so that the curative effect is durable and smooth, the acting time of the drug can be prolonged, the number of administration times can be reduced, the compliance of patients can be improved, and thus use of the angelica oil transdermal patch can be stopped at any time. The angelica oil transdermal patch represents the effective, safe, convenient and humanized administration therapeutic characteristics.
Description
One, technical field
The invention belongs to medical technical field, relate to a kind of Radix Angelicae Sinensis oil transdermal patch for the treatment of dysmenorrhea and preparation method thereof.
Two, background technology
Dysmenorrhea refers to gynecologic menstrual or the front and back of passing through, and periodically occurs lower abdomen spasmic pain, or falling inflation sense, or bitterly draws waist sacrum, and when serious, with symptoms such as nauseating, vomiting, cold extremities, even severe pain is fainted, genus motherland's medical science " abdominal pain during menstruation " category.Can be divided into clinically 2 large classes: a class is that the dysmenorrhea being caused by the clear and definite disease of genitals is called secondary dysmenorrhea; One class is that genitals is without the primary dysmenorrhea of significant organic pathological changes.According to the literature, in global women, 80% has dysmenorrhea in various degree, wherein approximately 3/4 impact study, work, and it is adolescent girls and young woman unmarried or that do not educate that colony mainly occurs.Dysmenorrhea causes absence from work without reason, the phenomenon of cutting classes very general, and has had a strong impact on patient's quality of life.
Pathogenesis Chinese and western medicine about dysmenorrhea has more deep understanding, western medicine primary dysmenorrhea has multiple therapy methods, NSAID (non-steroidal anti-inflammatory drug) is the most frequently used first-line treatment medicine, oral contraceptive can reach more than 90% this sick effective percentage, and calcium ion channel blocker, spasmolytic tranquilizer, receptor stimulating agent, vitamin E etc. are all effective medicines.These Western medicine unavoidably cause bad impact to human endocrine function.Chinese medicine dysmenorrhea has internal treatment and external treatment, has original curative effect, and side effect is little, and Clinical Basis is better, has certain development prospect.
Angelica essential oil has more report for the research of dysmenorrhea, Liu Shaoguang etc. nineteen thirty-five taken the lead in reporting Radix Angelicae Sinensis volatile oil for the isolated uterine of Canis familiaris L., rabbit, Cavia porcellus, have suppress to shrink, the myotonic effect of relaxing.The pharmacology of angelica essential oil report was more in recent years, as the mechanism for the treatment of dysmenorrhea, the pharmacodynamic study for the treatment of dysmenorrhea, suppress uterine myometrium mechanism, on the two-way function in uterus, on the impact of isolated uterine smooth muscle contraction function etc.Sun Shao Wujin row the clinical efficacy comparative study of Radix Angelicae Sinensis abdomen drip pills, Gao Yingmin has reported the analgesic effect of angelica essential oil ball to dysmenorrhea patient, Duan Zhixing has reported the flat soft gelatin capsule of Radix Angelicae Sinensis dysmenorrhea, the curative effect for the treatment of dysmenorrhea patient 322 examples.A large amount of pharmacology and clinical research confirmation, angelica essential oil can be alleviated uterine smooth muscle spasm effectively, for the definite curative effect of dysmenorrhea tool.
Transdermal drug delivery system or transdermal formulation (transdermal thrapeutic systems, transdermal drug delivery systems, be called for short TTS, TDDS): refer in skin surface administration, make medicine pass through skin with constant rate of speed (or approaching constant rate of speed), enter the Novel Drug Delivery Systems that body circulation produces whole body or local therapeutic effects.Its advantage applies exists: (1) transdermal drug delivery system can avoid the first pass effect of liver and medicine to affect in factors such as gastrointestinal tract pH, food, transhipment times. reduce the individual variation of medication.(2) maintain constant effective blood drug concentration or physiological effect, the blood drug level peak valley phenomenon of avoiding oral administration to cause, reduces toxicity.(3) reduce administration number of times, improve therapeutic efficacy, extend action time, avoid multiple dose administration, make most patient be easy to accept.(4) easy to use, independently medication of patient, also can cancel medication [1] at any time.I.e. drug treatment feature more effective, safer, more convenient, hommization more.
Transdermal drug delivery system belongs to one of pith of Modern New drug-supplying system, and Novel Drug Delivery Systems is promotion medicine differentiation, widens medical product, extends one of key factor of medicine life cycle.TTS preparation becomes the drug-supplying system of global focus development with its unique advantage, new varieties quantity is with annual 11.2% speed increase.According to statistics, 6,700,000,000 dollars of TTS preparation global marketing volumes in 2000,2003 are 9,100,000,000 dollars; 2010 800～1,000 hundred million dollars.U.S. the world of medicine thinks, in 10～15 years from now on, has 1/3 existing medication will adopt TTS preparation.Show that increasing medicine will be developed to TTS preparation.
Radix Angelicae Sinensis oil transdermal patch is the first TTS preparation of angelica essential oil, also belongs to first modern TTS Chinese medicine preparation in dysmenorrhea medication.Major embodiment following characteristics: (1) transdermal drug delivery system can avoid the first pass effect of liver and medicine to affect in factors such as gastrointestinal tract pH, food, transhipment times. reduce the individual variation of medication.(2) maintain constant effective blood drug concentration or physiological effect, the blood drug level peak valley phenomenon of avoiding oral administration to cause, reduces toxicity.(3) reduce administration number of times, improve treatment effect, can extend action time, avoid multiple dose administration, make most patient be easy to accept.(4) easy to use, independently medication of patient, also can cancel medication at any time.I.e. drug treatment feature more effective, safer, more convenient, hommization more.
Three, summary of the invention
The object of the present invention is to provide a kind of Radix Angelicae Sinensis oil transdermal patch for the treatment of dysmenorrhea and preparation method thereof.
Technical scheme of the present invention is: Radix Angelicae Sinensis oil transdermal patch comprises that backing layer, drug-reservoir, release-controlled film, pressure sensitive adhesive and adherent layer etc. partly form, medicine in drug-reservoir accounts for 20～40% principal agent Radix Angelicae Sinensis oil and consumption by consumption and accounts for 60～80% Polyethylene Glycol (PEG) substrate and form, and described PEG substrate is that two or more in PEG series is formulated.Backing layer is aluminum foil coating plastic film, plays sealing, the effect of protection drug depot.Release-controlled film is PE, the EVA high molecular polymer thin film of 50 μ m to 100 μ m.Pressure sensitive adhesive is medical pressure-sensitive adhesive, plays the effect that makes preparation capable of permeating skin be attached on skin.Adherent layer is surperficial through silicone oil release treatment or fluorine-containing polyester film or paper, plays the effect of protection adhered layer, tears off before use.
This patch be take Radix Angelicae Sinensis oil and is formed as main medicine and other adjuvant coordinate, being about to Radix Angelicae Sinensis oil mixs homogeneously with PEG substrate to make after Radix Angelicae Sinensis oil ointment and is coated with and is layered on backing layer, then cover release-controlled film, pressure sensitive adhesive and adherent layer, concrete preparation technology: 1) by two kinds and above PEG substrate heat fused mix homogeneously; 2) get in proportion Radix Angelicae Sinensis oil, mix homogeneously with substrate heating, can be made into Radix Angelicae Sinensis oil ointment; 3) ointment is coated with on backing layer to the drug-reservoir of paving thickness 0.2mm～0.5mm, area 4～6cm * 6～8cm, then covers PE, the EVA high molecular polymer release-controlled film of 50 μ m to 100 μ m, the sealing of surrounding thermoplastic; 4) first medical pressure-sensitive adhesive heat seeling coating is in adherent layer, then mucilage glue surface is covered in outside release-controlled film, and also can be coated with PEG substrate outward at release-controlled film, then cover adherent layer, and another attached Surgidressing; 5) aluminum-plastic composite membrane bag hermetic package, is stored in cool place, lucifuge place.
The present invention can be by the control dosage of administration area, and patch location is covered on lower abdomen, and medicine, through Transdermal absorption, produces the curative effect for the treatment of dysmenorrhea.
Patch provided by the present invention, medicine discharges with zero level, continual and steady release in 48 hours, thus make curative effect long lasting and stable; Result of the test also shows that patch of the present invention has good controlled release drug release characteristic.
The invention has the beneficial effects as follows: the first TTS preparation that Radix Angelicae Sinensis oil transdermal patch is angelica essential oil also belongs to first modern TTS Chinese medicine preparation in dysmenorrhea medication.Major embodiment following characteristics: (1) transdermal drug delivery system can avoid the first pass effect of liver and medicine to affect in factors such as gastrointestinal tract pH, food, transhipment times. reduce the individual variation of medication.(2) maintain constant effective blood drug concentration or physiological effect, the blood drug level peak valley phenomenon of avoiding oral administration to cause, reduces toxicity.(3) reduce administration number of times, improve treatment effect, can extend action time, avoid multiple dose administration, make most patient be easy to accept.(4) easy to use, independently medication of patient, also can cancel medication at any time.I.e. drug treatment feature more effective, safer, more convenient, hommization more.The present invention can be by the control dosage of administration area, and patch location is covered on lower abdomen, and medicine, through Transdermal absorption, produces the curative effect for the treatment of dysmenorrhea.Medicine discharges with zero level, continual and steady release in 48 hours, thus make curative effect long lasting and stable; Result of the test also shows that the present invention has good controlled release drug release characteristic.
Below in conjunction with accompanying drawing, the invention will be further described.
Four, accompanying drawing explanation
Fig. 1 is product structure schematic diagram of the present invention;
Fig. 2 is the releasing curve diagram of Radix Angelicae Sinensis oil transdermal patch of the present invention.
In figure: 1 is backing layer, 2 is drug-reservoir, and 3 is release-controlled film, and 4 is pressure sensitive adhesive, and 5 is adherent layer.
Five, the specific embodiment
As shown in Figure 1, Radix Angelicae Sinensis oil transdermal patch is to consist of backing layer 1, drug-reservoir 2, release-controlled film 3, pressure sensitive adhesive 4 and adherent layer 5, and backing layer 1 is selected aluminium foil plastic-coated film production, plays sealing, protection drug depot; Medicine in drug-reservoir 2 comprises that consumption accounts for 20～40% principal agent Radix Angelicae Sinensis oil and accounts for 60～80% Polyethylene Glycol (PEG) substrate, and PEG substrate is that two or more in PEG series is formulated; Release-controlled film 3 is high molecular polymer, comprises PE film, the EVA film of 50 μ m to 100 μ m.Pressure sensitive adhesive 4 is selected medical pressure-sensitive adhesive, plays the effect that makes preparation capable of permeating skin be attached on skin; Adherent layer 5 is surperficial through silicone oil release treatment or fluorine-containing polyester film or paper, plays the effect of protection adhered layer, tears off before use.
The Radix Angelicae Sinensis oil transdermal patch preparation method for the treatment of dysmenorrhea is Radix Angelicae Sinensis oil to be mixed homogeneously with PEG substrate make after Radix Angelicae Sinensis oil ointment to be coated with and to be layered on backing layer, then covers release-controlled film, pressure sensitive adhesive and adherent layer, and specifically preparation technology is as follows:
1) by two kinds and above PEG substrate heat fused mix homogeneously;
2) get in proportion Radix Angelicae Sinensis oil, mix homogeneously with substrate heating, can be made into Radix Angelicae Sinensis oil ointment;
3) ointment is coated with on backing layer to the drug-reservoir of paving thickness 0.2mm～0.5mm, area 4～6cm * 6～8cm, then covers PE, the EVA high molecular polymer release-controlled film of 50 μ m to 100 μ m, the sealing of surrounding thermoplastic;
4) first medical pressure-sensitive adhesive heat seeling coating is in adherent layer, then mucilage glue surface is covered in outside release-controlled film, and also can be coated with PEG substrate outward at release-controlled film, then cover adherent layer, and another attached Surgidressing;
5) aluminum-plastic composite membrane bag hermetic package, is stored in cool place, lucifuge place.
Below by following example, explain more in detail the present invention, should be understood that: the present invention never only limits to embodiment, or not only show as embodiment.
Embodiment 1:(1) by PEG400 4g and PEG4000 5g heat fused mix homogeneously.(2) get Radix Angelicae Sinensis oil 4g, mix homogeneously with substrate heating, make Radix Angelicae Sinensis oil ointment.(3) ointment is coated with on backing film to paving (thickness 0.3mm, area 4cm x6cm or 6cm x8cm), covers EVA release-controlled film (thickness 50 μ m), the sealing of surrounding thermoplastic.(4) pressure sensitive adhesive heat seeling coating, on adherent layer, is covered in mucilage glue surface outside release-controlled film.(5) with aluminum-plastic composite membrane bag hermetic package, be stored in cool place, lucifuge place.
Embodiment 2:(1) by PEG400 4g and PEG4000 5g heat fused mix homogeneously.(2) get Radix Angelicae Sinensis oil 4g, mix homogeneously with substrate heating, make Radix Angelicae Sinensis oil ointment.(3) ointment is coated with on backing film to paving (thickness 0.5mm, area 4cm x6cm or 6cm x8cm), covers EVA release-controlled film (thickness 50 μ m), the sealing of surrounding thermoplastic.(4) at release-controlled film, be coated with PEG substrate (thickness 0.2mm) outward, then cover adherent layer, and another attached Surgidressing.(5) with aluminum-plastic composite membrane bag hermetic package, be stored in cool place, lucifuge place.
Embodiment 3:(1) by PEG400 40g and PEG4000 50g heat fused mix homogeneously.(2) get Radix Angelicae Sinensis oil 40g, mix homogeneously with substrate heating, make Radix Angelicae Sinensis oil ointment.(3) ointment is coated with on backing film to paving (thickness 0.4mm, area 4cm x6cm or 6cm x8cm), covers EVA release-controlled film (thickness 50 μ m), the sealing of surrounding thermoplastic.(4) at release-controlled film, be coated with PEG substrate (thickness 0.2mm) outward, then cover adherent layer, and another attached Surgidressing.(5) with aluminum-plastic composite membrane bag hermetic package, be stored in cool place, lucifuge place.
Embodiment 4:(1) by PEG400 4g and PEG4000 5g heat fused mix homogeneously.(2) get Radix Angelicae Sinensis oil 4g, mix homogeneously with substrate heating, make Radix Angelicae Sinensis oil ointment.(3) ointment is coated with on backing film to paving (thickness 0.5mm, area 4cm x6cm or 6cm x8cm), covers PE release-controlled film (thickness 50 μ m), the sealing of surrounding thermoplastic.(4) at release-controlled film, be coated with PEG substrate (thickness 0.2mm) outward, then cover adherent layer, and another attached Surgidressing.(5) with aluminum-plastic composite membrane bag hermetic package, be stored in cool place, lucifuge place.
Embodiment 5: the release of Radix Angelicae Sinensis oil transdermal patch medicine.Adopt the apparatus of Chinese Pharmacopoeia drug release determination the 3rd method, release medium is the normal saline 1000mL containing 30% ethanol, medium temperature keeps 32 ± 0.5 ℃, adjust rotating speed and keep stable, draw solution is appropriate at the appointed time, measures the burst size of principal agent, the release (%) of take is vertical coordinate, time (h) is the drug release curve of abscissa drafting transdermal patch, Regression Analysis Result: Y=1.7301X+4.5391, r=0.9922.The release that shows this patch medicine meets zero order kinetics equation.Patch provided by the present invention, medicine discharges with zero level, has continual and steady release drug release characteristic (the results are shown in Table 1 and accompanying drawing 2).
The release of table 1. Radix Angelicae Sinensis oil transdermal patch
| Time (h) | Release (%) |
| 1 | 2.92 |
| 2 | 5.83 |
| 4 | 8.75 |
| 8 | 20.41 |
| 12 | 29.2 |
| 24 | 52.44 |
| 36 | 66.96 |
| 48 | 83.36 |
Claims (3)
1. a Radix Angelicae Sinensis oil transdermal patch, it comprises backing layer (1), drug-reservoir (2), release-controlled film (3), pressure sensitive adhesive (4) and adherent layer (5), it is characterized in that: the medicine in drug-reservoir (2) accounts for 20～40% principal agent Radix Angelicae Sinensis oil and consumption by consumption and accounts for 60～80% Polyethylene Glycol PEG substrate and form, and described PEG substrate is that two kinds in PEG series are above formulated.
2. Radix Angelicae Sinensis oil transdermal patch according to claim 1, it is characterized in that: backing layer (1) is aluminum foil coating plastic film, release-controlled film (3) is PE, the EVA high molecular polymer thin film of 50 μ m to 100 μ m, pressure sensitive adhesive (4) is medical pressure-sensitive adhesive, and adherent layer (5) is that surface is through silicone oil release treatment or fluorine-containing polyester film, paper.
3. the preparation method of a Radix Angelicae Sinensis oil transdermal patch, it is characterized in that: it be take Radix Angelicae Sinensis oil and forms as main medicine and other adjuvant coordinate, being about to Radix Angelicae Sinensis oil mixs homogeneously with PEG substrate to make after Radix Angelicae Sinensis oil ointment and is coated with and is layered on backing layer, then cover release-controlled film, pressure sensitive adhesive and adherent layer, concrete preparation technology is as follows:
(1) by two kinds and above PEG substrate heat fused mix homogeneously;
(2) get in proportion Radix Angelicae Sinensis oil, mix homogeneously with substrate heating, can be made into Radix Angelicae Sinensis oil ointment;
(3) ointment is coated with on backing layer to the drug-reservoir of paving thickness 0.2mm～0.5mm, area 4～6cm * 6～8cm, then covers PE, the EVA high molecular polymer release-controlled film of 50 μ m to 100 μ m, the sealing of surrounding thermoplastic;
(4) first medical pressure-sensitive adhesive heat seeling coating is in adherent layer, then mucilage glue surface is covered in outside release-controlled film, and also can be coated with PEG substrate outward at release-controlled film, then cover adherent layer, and another attached Surgidressing;
(5) aluminum-plastic composite membrane bag hermetic package, is stored in cool place, lucifuge place.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN201410241605.XA CN103976983A (en) | 2014-06-03 | 2014-06-03 | Angelica oil transdermal patch and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410241605.XA CN103976983A (en) | 2014-06-03 | 2014-06-03 | Angelica oil transdermal patch and preparation method thereof |
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| CN103976983A true CN103976983A (en) | 2014-08-13 |
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| CN201410241605.XA Pending CN103976983A (en) | 2014-06-03 | 2014-06-03 | Angelica oil transdermal patch and preparation method thereof |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104435027A (en) * | 2014-11-14 | 2015-03-25 | 南京中医药大学 | Pharmaceutical composition delivered in transdermal manner for treating dysmenorrhea, external preparation prepared by using pharmaceutical composition, and preparation method of external preparation |
| WO2018072755A1 (en) * | 2016-10-21 | 2018-04-26 | 温红卫 | Self-heating plaster having reflective metal layer |
| CN114515221A (en) * | 2022-01-27 | 2022-05-20 | 广东海洋大学 | Method for producing compound cassia twig decoction essential oil warm patch |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1432363A (en) * | 2002-12-24 | 2003-07-30 | 复旦大学 | Transdermal Ligustrazine plaster and its prepn |
| CN101049329A (en) * | 2006-04-07 | 2007-10-10 | 刘志峰 | Application of angelica oil in raising level of estradiol from internal source for treating estradiol related disease |
-
2014
- 2014-06-03 CN CN201410241605.XA patent/CN103976983A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1432363A (en) * | 2002-12-24 | 2003-07-30 | 复旦大学 | Transdermal Ligustrazine plaster and its prepn |
| CN101049329A (en) * | 2006-04-07 | 2007-10-10 | 刘志峰 | Application of angelica oil in raising level of estradiol from internal source for treating estradiol related disease |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104435027A (en) * | 2014-11-14 | 2015-03-25 | 南京中医药大学 | Pharmaceutical composition delivered in transdermal manner for treating dysmenorrhea, external preparation prepared by using pharmaceutical composition, and preparation method of external preparation |
| WO2018072755A1 (en) * | 2016-10-21 | 2018-04-26 | 温红卫 | Self-heating plaster having reflective metal layer |
| CN114515221A (en) * | 2022-01-27 | 2022-05-20 | 广东海洋大学 | Method for producing compound cassia twig decoction essential oil warm patch |
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Application publication date: 20140813 |
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