CN101518599A - Slow-release patch with daphne giraldii bark extract, and preparation method thereof - Google Patents
Slow-release patch with daphne giraldii bark extract, and preparation method thereof Download PDFInfo
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- CN101518599A CN101518599A CN200910010827A CN200910010827A CN101518599A CN 101518599 A CN101518599 A CN 101518599A CN 200910010827 A CN200910010827 A CN 200910010827A CN 200910010827 A CN200910010827 A CN 200910010827A CN 101518599 A CN101518599 A CN 101518599A
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- menthol
- daphne giraldii
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Abstract
The invention belongs to the technical field of medicament, and discloses a percutaneous slow-release patch with a daphne giraldii bark extract, and a reparation method thereof. The patch with the daphne giraldii bark extract comprises a back lining layer, a drug reservoir and an antisticking layer, wherein the drug reservoir consists of the daphne giraldii bark extract, pressure sensitive adhesive and a percutaneous absorption accelerator; plasticizer, tackifier and antioxidant and the like can be added if needed; the selected pressure sensitive adhesive is silicone pressure sensitive adhesive, isobutylene pressure sensitive adhesive or acrylate pressure sensitive adhesive, and can select one or more compounds therein. The percutaneous patch has the advantages that the percutaneous patch can prevent oral administration from causing liver first-pass effect and irritating gastrointestinal tracts, overcomes deficiency that ointment, plaster, liniment, cream and other preparations are uncertain in dosage, easy to pollute clothes and the like, is constant in drug-releasing speed, ensures lasting steady therapeutic effect, and is convenient to use, good in flexibility and suitable in adhesion. The 24-hour accumulated permeation amount of daphnetin in a daphne giraldii bark patch prepared by the method is obviously higher than that of the commercially available daphne giraldii bark plaster.
Description
Technical field:
The invention belongs to medical technical field, relate to slow-release patch with daphne giraldii bark extract and preparation method thereof, this slow-release patch can be treated scapulohumeral periarthritis, arthritis, lumbago and skelalgia, traumatic injury and be related to diseases such as the pain that causes, swelling.
Background technology:
Arthritis, scapulohumeral periarthritis, lumbago and skelalgia, traumatic injury be a kind of sickness rate height, relate to multiple widely, the wide property the sent out disease of crowd.According to World Health Organization's statistics, among the crowd more than 55 years old, the arthritis sickness rate is 80%.World Health Organization (WHO) in 1999 classifies arthritis and cardiovascular disease and cancer as threaten human health three big killers.Common saying: ＂ is painful as completely to climb, and be unable to do without Daphne giraldii Nitsche ＂.The hot temperature of Daphne giraldii Nitsche is gone into liver, reducing swelling and alleviating pain, and promoting blood circulation to remove obstruction in the collateral is the pain relieving famous medicine of using of a specified duration among the people.The compound preparation that contains Daphne giraldii Nitsche at present mainly contains injection, tablet, plaster etc.Injection for curing brings huge painful and consumption to the patient, and oral anti-inflammation analgesia medicine etc. remove common gastrointestinal side reaction, also have potential cardiovascular risk, so Chinese medicine percutaneous dosing approach is called the focus of modern medicine research.
Domestic scholars has been reported relevant effective parts of cirald daphne bark preparation method.Publication number is the preparation that the patent (a kind of effective parts of cirald daphne bark and preparation method thereof and application) of CN1883618A has been reported a kind of effective parts of cirald daphne bark, water or lower alcohol or moisture lower alcohol dipping or percolation are extracted, the use Amberlyst process separates, and does not mention ultrasonic extraction and silica gel partition method.Dipping and percolation length all consuming time, efficient is low, and macroporous resin application low concentration alcohol-water solution eluting, and its main effective ingredient Daphnetin structure is extremely unstable, and is perishable in aqueous solution, the yield instability.And ultrasonic method efficient, save time, easy operating, and during silicagel column partition method purification, crude extract contact with water in the whole separation and purification process, the chromatograph gradient elution, good separating effect, yield is high and stablize.Publication number is that the patent (detoxicated girald daphne and externally applied transdermal absorption preparation thereof and preparation technology) of CN1857702A has reported that detoxicated girald daphne gets the preparation method of thing extractum and spray and gel, not at patch.Detoxicated girald daphne extractum is that Daphne giraldii Nitsche decocts with medical herbs such as Rhizoma Zingiberis Recens, Radix Glycyrrhizaes and makes, the Daphne giraldii Nitsche crude extract is not carried out the separation and purification of modern crafts, in addition owing to spray, gel etc. also have some problems that are difficult to overcome in the use, must be through frequently spraying, embrocating, solvent evaporates then, drug exposure is at skin surface, not only medicine is easily separated out crystallization, and wiped by clothes easily, cause dose not enough, the curative effect instability.Compare with above-mentioned dosage form, with the patch of pressure sensitive adhesive preparation have that administration number of times is few, dosage is accurate, peel strength is good, with skin adhesive firmly, to the sharp zest of skin and anaphylaxis extremely a little less than, medication is convenient, and is evident in efficacy, the good advantage of patient's compliance.Therefore the present invention researches and develops Daphne giraldii Nitsche pressure sensitive adhesive decentralized patch.
Summary of the invention:
The object of the present invention is to provide a kind of Daphne giraldii Nitsche extract's percutaneous slow-release patch and preparation method thereof.The present invention makes the percutaneous patch with the refining extractum of Daphne giraldii Nitsche.This percutaneous patch divides three layers, adherent layer, backing layer and drug storing layer, and wherein adherent layer is identical with common transdermal patch with backing layer, and drug storing layer claims the intermediate layer again, for Drug Storage and pressure sensitive adhesive amalgamation layer, is made up of medicine and substrate.Its substrate comprises silicone pressure-sensitive adhesive or isobutylene type polymer or acrylic polymer and their derivant, compound transdermal enhancer.Medicine is the Daphne giraldii Nitsche extract; The Daphne giraldii Nitsche extract accounts for the 0.5-20wt% of drug storing layer, and the pressure sensitive adhesive consumption accounts for the 70-99wt% of drug storing layer, and the total consumption of compound transdermal absorption accelerator accounts for the 0-20wt% of drug storing layer, can add a certain amount of antioxidant when being necessary.
Transdermal absorption accelerator has been selected propylene glycol for use, glycerol, PEG300, PEG400, dimethyl acetylamide, diethyl ethylene diamine, diethylamine, triethylamine, N-methylmorpholine, benzyl ammonium chloride, azone, carbamide, glycerol list oleic acid) ester, glyceryl monolaurate, glycerol trioleate, isopropyl myristate, dibutyl sebacate, dibutyl phthalate, geraniol, nerolidol, menthol, the menthol ethyl ester, the menthol propyl ester, the menthol butyl ester, the menthol pentyl ester, the own ester of menthol, the menthol heptyl ester, the menthol monooctyl ester, menthol ester in the ninth of the ten Heavenly Stems, menthol ester in the last of the ten Heavenly stems, menthol ten diester, menthol 14 esters, the menthol hexadecyl ester, menthol stearic acid ester, the menthol oleate, menthanol lactic acid ester, the menthol salicylate, menthol ester, Camphora, eucalyptus oil, Borneolum Syntheticum, the N-N-methyl-2-2-pyrrolidone N-, tween 20, Tween-40, Tween-60, tween 80, Arlacel-20, Arlacel-40, Arlacel-60, Arlacel-80, lactic acid, maleic acid, fumaric acid, in the oxalic acid one or more are as compound transdermal enhancer, and its total consumption is 0% to 20%.
Described Daphne giraldii Nitsche extract is for being obtained by following extraction separation method: 6-12 doubly measures 50%-90% ethanol ultrasonic extraction 30min-120min, and 6-10 doubly measures the ultrasonic 30min-90min of 50%-90% ethanol, merge extractive liquid; Remove ethanol under reduced pressure and get aqueous solution, equivalent ethyl acetate extraction three times merges back evaporate to dryness ethyl acetate and gets extractum, and the rate of extract is a 80:1 (crude drug weight: extractum weight); The small amount of methanol dissolving, 3-6 doubly measures silica gel mixed sample, and it is divided silicon mucilage binding post that 5-20 doubly mixes sample silica gel, last sample, petroleum ether-ethyl acetate system eluting (ratio is 20:1-1:2), HPLC detects every flow point Daphnetin content, merges to contain the Daphnetin flow point; Remove solvent under reduced pressure and get the Daphne giraldii Nitsche extract.Daphnetin content 〉=30%.
Backing layer is selected for use and is contained the aluminumpolyethylene composite membrane, or elastic non-woven cloth.Adherent layer is polyester film or the paper of surface through the silicone oil release treatment.
The preparation technology of described patch is that the transdermal absorption accelerator with principal agent Daphne giraldii Nitsche extract, pressure sensitive adhesive and certain kind fully mixes, transfer coated is on silicone oil base paper, through 30-120 ℃ of drying, 5min-50min then with comprise PVC or non-woven fabrics to mount the backing material compound, be die-cut into 10cm
2～50cm
2Promptly.The thick 50 μ m of glue-line～100 μ m.
Daphne giraldii Nitsche extract's percutaneous slow-release patch of the present invention can be by the adjustment control dosage of administration area, and medicine discharges with zero level, 24 hours continual and steady release medicines, thus make the curative effect long lasting and stable; If want interruption of the administration, only need throw off patch and get final product, easy to use; This patch also has adhesiveness, compliance is good; Advantages such as zest is minimum.
The specific embodiment:
By the more explained in detail the present invention of following example, should be understood that: the present invention never only limits to embodiment, perhaps only shows as embodiment.
Embodiment 1
Daphne giraldii Nitsche medical material 500 grams, 4 liter of 90% ethanol ultrasonic extraction 60min for the first time, 4 liter of 90% ultrasonic 30min merge extractive liquid, of ethanol for the second time, steaming removes ethanol and gets aqueous solution, equivalent ethyl acetate collection three times, merge back evaporate to dryness ethyl acetate and get extractum 6.25 grams, the small amount of methanol dissolving, 5 times of heavy silica gel mixed samples of amount extractum, 15 times are mixed sample silica gel amount is divided silicon mucilage binding post, last sample, ethyl acetate-petroleum ether system eluting, HPLC detects every flow point Daphnetin content, merges to contain the Daphnetin flow point, steam desolventize the about 1g of Daphne giraldii Nitsche extract.The recipe quantity Daphne giraldii Nitsche extract is dissolved in an amount of ethyl acetate and recipe quantity penetrating agent and the abundant mixing of pressure sensitive adhesive, evenly coats on the adherent layer, through 60 ℃ of dryings 20 minutes, then with comprise PVC or non-woven fabrics to mount the backing material compound, be die-cut into 10cm
2Promptly.The thick 80 μ m of glue-line～100 μ m.
Prescription is formed: Daphne giraldii Nitsche extract 0.03g (1%)
Acrylate pressure sensitive adhesive 2.96g (99%)
Embodiment 2
It is composed as follows to remove prescription, and all the other use method similarly to Example 1.
Prescription is formed: Daphne giraldii Nitsche extract 0.03g (1%)
Polyisobutylene PSA 2.96g (99%)
Embodiment 3
Prescription is formed: Daphne giraldii Nitsche extract 0.03g (1%)
Polyisobutylene PSA 2.94g (98%)
Cinnamic acid menthol ester 0.03g (1%)
Embodiment 4
It is composed as follows to remove prescription, and all the other use method similarly to Example 1.
Prescription is formed: Daphne giraldii Nitsche extract 0.03g (1%)
Polyisobutylene PSA 2.94g (98%)
Azone 0.03g (1%)
Embodiment 5
It is composed as follows to remove prescription, and all the other use method similarly to Example 1.
Prescription is formed: Daphne giraldii Nitsche extract 0.15g (5%)
Polyisobutylene PSA 2.31g (77%)
Cinnamic acid menthol ester 0.24g (8%)
Azone 0.15g (5%)
Propylene glycol 0.15g (5%)
Embodiment 6
It is composed as follows to remove prescription, and all the other use method similarly to Example 1.
Prescription is formed: Daphne giraldii Nitsche extract 0.6g (20%)
Polyisobutylene PSA 2.10g (70%)
Cinnamic acid menthol ester 0.15g (5%)
Azone 0.12g (4%)
Vitamin E 0.03g (1%)
In-vitro percutaneous test:
Male rat about 180g is anaesthetized with 20% urethane, cut off belly wool, the hair that the reuse electric shaver carefully will be left is rejected clean, rat is put to death in the cervical vertebra dislocation, peel off skin, remove subcutaneous fat, be in store in-30 ℃ with the clean back of normal saline flushing.
Adopt improved Franz diffusion cell to carry out the percutaneous absorption test, 32 ℃ of bath temperatures, percutaneous area 0.96cm
2, reception tank volume 2.5ml, receiving liquid is the pH7.4 phosphate buffered solution.Patch is pasted on keratodermatitis, is fixed on the reception tank,, replenish the blank liquid that receives of 2ml respectively at 2,4,6,8,10,12,24 hours sampling 2ml.Sample is analyzed with high performance liquid chromatography.
Daphnetin HPLC condition determination chromatographic column: Inertsil ODS C18 post (250mm * 4.6mm); Mobile phase: mobile phase is methanol: 5% glacial acetic acid solution (40:60); Detect wavelength: 325nm; Flow velocity: 1.0mL/min; Sample size: 20 μ L.
Record Daphnetin 24h accumulative total transit dose result among the above embodiment and be respectively 13.66,16.96,55.29,38.22,283.37 and 630.65 μ g/cm
2
Claims (8)
1. slow-release patch with daphne giraldii bark extract, constitute by backing layer, drug storing layer and adherent layer, it is characterized in that: drug storing layer comprises Daphne giraldii Nitsche extract, pressure sensitive adhesive, transdermal absorption accelerator, wherein the Daphne giraldii Nitsche extract accounts for the 0.5-20wt% that drug storing layer is formed, the pressure sensitive adhesive consumption accounts for the 70-99wt% that drug storing layer is formed, and the total consumption of compound transdermal absorption accelerator accounts for the 0-20wt% that drug storing layer is formed.
2. slow-release patch with daphne giraldii bark extract according to claim 1, it is characterized in that: the Daphne giraldii Nitsche extract is obtained by following extraction separation method: 6-12 doubly measures 50%-90% ethanol ultrasonic extraction 30min-120min, 6-10 doubly measures the ultrasonic 30min-90min of 50%-90% ethanol, merge extractive liquid; Remove ethanol under reduced pressure and get aqueous solution, equivalent ethyl acetate extraction three times merges back evaporate to dryness ethyl acetate and gets extractum, and the rate of extract is a 80:1 (crude drug weight: extractum weight); The small amount of methanol dissolving, 3-6 doubly measures silica gel mixed sample, and it is divided silicon mucilage binding post that 5-20 doubly mixes sample silica gel, last sample, petroleum ether-ethyl acetate system eluting (ratio is 20:1-1:2), HPLC detects every flow point Daphnetin content, merges to contain the Daphnetin flow point; Remove solvent under reduced pressure and get the Daphne giraldii Nitsche extract, Daphnetin content 〉=30%.
3. slow-release patch with daphne giraldii bark extract according to claim 1 is characterized in that: the selected host material of pressure sensitive adhesive is one or more chemical compounds in silicone, isobutylene type polymer or acrylic polymer and their derivant.
4. slow-release patch with daphne giraldii bark extract according to claim 1, it is characterized in that: described transdermal absorption accelerator is a propylene glycol, glycerol, PEG300, PEG400, dimethyl acetylamide, diethyl ethylene diamine, diethylamine, triethylamine, N-methylmorpholine, benzyl ammonium chloride, azone, carbamide, glycerin mono-fatty acid ester, glyceryl monolaurate, glycerol trioleate, isopropyl myristate, dibutyl sebacate, dibutyl phthalate, geraniol, nerolidol, menthol, the menthol ethyl ester, the menthol propyl ester, the menthol butyl ester, the menthol pentyl ester, menthol is own, the menthol heptyl ester, the menthol monooctyl ester, menthol ester in the ninth of the ten Heavenly Stems, menthol ester in the last of the ten Heavenly stems, menthol ten diester, menthol 14 esters, the menthol hexadecyl ester, ester menthol stearic acid ester, the menthol oleate, menthanol lactic acid ester, the menthol salicylate, menthol ester, Camphora, eucalyptus oil, Borneolum Syntheticum, the N-N-methyl-2-2-pyrrolidone N-, tween 20, Tween-40, Tween-60, tween 80, Arlacel-20, Arlacel-40, Arlacel-60, Arlacel-80, lactic acid, maleic acid, fumaric acid, in the oxalic acid one or more, its total consumption is 0% to 20%.
5. slow-release patch with daphne giraldii bark extract according to claim 1 is characterized in that: backing layer is selected for use and is contained the aluminumpolyethylene composite membrane, or elastic non-woven cloth.
6. slow-release patch with daphne giraldii bark extract according to claim 1 is characterized in that: adherent layer is polyester film or the paper of surface through the silicone oil release treatment.
7. slow-release patch with daphne giraldii bark extract according to claim 1 is characterized in that: also can add antioxidant.
8. the preparation method of a slow-release patch with daphne giraldii bark extract as claimed in claim 1, it is characterized in that: Daphne giraldii Nitsche extract, pressure sensitive adhesive and transdermal absorption accelerator are fully mixed, transfer coated is on silicone oil base paper, through 30-120 ℃ of drying, 5min-50min, with comprising the compound of PVC or non-woven fabrics, be die-cut into 10cm then by the backing material
2～50cm
2, promptly make slow-release patch with daphne giraldii bark extract, the thick 50 μ m of glue-line～100 μ m.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200910010827A CN101518599A (en) | 2009-03-24 | 2009-03-24 | Slow-release patch with daphne giraldii bark extract, and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200910010827A CN101518599A (en) | 2009-03-24 | 2009-03-24 | Slow-release patch with daphne giraldii bark extract, and preparation method thereof |
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|---|---|
| CN101518599A true CN101518599A (en) | 2009-09-02 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN200910010827A Pending CN101518599A (en) | 2009-03-24 | 2009-03-24 | Slow-release patch with daphne giraldii bark extract, and preparation method thereof |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103181909A (en) * | 2011-12-31 | 2013-07-03 | 中国人民解放军军事医学科学院毒物药物研究所 | Daphnetin slow-release composition and preparation method thereof |
| CN104870005A (en) * | 2012-12-14 | 2015-08-26 | 莫茨药物股份两合公司 | Patch comprising an onion extract |
| CN107198762A (en) * | 2017-05-31 | 2017-09-26 | 华子昂 | It is a kind of that there is plaster for the treatment of mammary gland disease and preparation method thereof |
| CN108697655A (en) * | 2015-12-30 | 2018-10-23 | 考里安国际公司 | System and method for long-term transdermal administration |
| CN110545785A (en) * | 2017-04-04 | 2019-12-06 | 花王株式会社 | Body cosmetic |
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| CN1565523A (en) * | 2003-07-03 | 2005-01-19 | 上海现代药物制剂工程研究中心 | Percutaneous plaster and its preparation method |
| CN1883618A (en) * | 2005-06-21 | 2006-12-27 | 天津药物研究院 | Effective parts of cirald daphne bark, preparation method and application thereof |
| CN101371879A (en) * | 2008-10-10 | 2009-02-25 | 甘肃奇正藏药有限公司 | Aconitum sinomontanum transdermal paster and preparation method thereof |
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Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1565523A (en) * | 2003-07-03 | 2005-01-19 | 上海现代药物制剂工程研究中心 | Percutaneous plaster and its preparation method |
| CN1559466A (en) * | 2004-03-11 | 2005-01-05 | 秦皇岛市山海关制药厂 | Traditional Chinese medicinal plaster |
| CN1883618A (en) * | 2005-06-21 | 2006-12-27 | 天津药物研究院 | Effective parts of cirald daphne bark, preparation method and application thereof |
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Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103181909A (en) * | 2011-12-31 | 2013-07-03 | 中国人民解放军军事医学科学院毒物药物研究所 | Daphnetin slow-release composition and preparation method thereof |
| CN103181909B (en) * | 2011-12-31 | 2015-03-11 | 中国人民解放军军事医学科学院毒物药物研究所 | Daphnetin slow-release composition and preparation method thereof |
| CN104870005A (en) * | 2012-12-14 | 2015-08-26 | 莫茨药物股份两合公司 | Patch comprising an onion extract |
| CN104870005B (en) * | 2012-12-14 | 2019-06-11 | 莫茨药物股份两合公司 | Patch containing Herba Alii fistulosi extract |
| CN108697655A (en) * | 2015-12-30 | 2018-10-23 | 考里安国际公司 | System and method for long-term transdermal administration |
| CN108697655B (en) * | 2015-12-30 | 2021-12-10 | 考里安公司 | Systems and methods for long-term transdermal administration |
| US11648214B2 (en) | 2015-12-30 | 2023-05-16 | Corium, Llc | Systems and methods for long term transdermal administration |
| US11679086B2 (en) | 2015-12-30 | 2023-06-20 | Corium, Llc | Systems comprising a composite backing and methods for long term transdermal administration |
| CN110545785A (en) * | 2017-04-04 | 2019-12-06 | 花王株式会社 | Body cosmetic |
| CN107198762A (en) * | 2017-05-31 | 2017-09-26 | 华子昂 | It is a kind of that there is plaster for the treatment of mammary gland disease and preparation method thereof |
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Application publication date: 20090902 |