CN101468138A - Gel patch for treating insomnia and method for preparing the same - Google Patents
Gel patch for treating insomnia and method for preparing the same Download PDFInfo
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- CN101468138A CN101468138A CNA2007100604660A CN200710060466A CN101468138A CN 101468138 A CN101468138 A CN 101468138A CN A2007100604660 A CNA2007100604660 A CN A2007100604660A CN 200710060466 A CN200710060466 A CN 200710060466A CN 101468138 A CN101468138 A CN 101468138A
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Abstract
The present invention relates to a gel plaster for sleep disorder and its preparation mehtod thereof, composed of 2% -100% of extract of traditional Chinese medicine and 98% -0% of medicinal adjuvant, wherein the extracts of the lily, tuckahoe are the water-soluble extracts using water extraction method and the extracts of spiny jujube seed, polygala root are fat-soluble extracts using alcohol extraction method. The traditional Chinese medicine plaster is prepared by mixing the molecule gel with the hydrogel and the water-soluble medicine enters into the skin through a water-based channel and the fat-soluble medicine enters into the skin by a fat-soluble channel, thus the production technique prevents the separation of medicine and matrix, at the same time a certain repulsion force of oil-based matrix to the water-based medicine and a certain repulsion force of water-based matrix to the oil-based medicine can promote the medicine absorption and the medicine efficacy is increased.
Description
Technical field
The present invention relates to up-to-date molecular gel novel form of Percutaneously administrable preparation technical field and hydrogel dosage form, add Transdermal absorption gel adhesive of medicinal substrate Cure for insomnia and preparation method thereof with Chinese medicine extract.
Background technology
Transdermal drug delivery system or percutaneous absorption patch refer to stick the mode medication through skin, and medicine enters the systemic blood circulation by skin absorbs and reaches a class preparation of effective blood drug concentration, realization disease treatment or prevention.The characteristics of percutaneous absorption patch are, transdermal drug delivery system can avoid the first pass effect of liver and medicine in the gastrointestinal deactivation, the absorption of medicine is not subjected to the influence of gastrointestinal factors, reduce the individual variation of medication, keep constant effective blood drug concentration or physiological effect, the blood drug level peak valley phenomenon of avoiding oral administration to cause reduces toxicity.Reduce administration number of times, improve therapeutic efficacy, prolong action time, avoid multiple dose administration, make most patient be easy to accept, simultaneously easy to use, independently medication of patient also can be cancelled medication at any time.
The profit ampholytic gels is meant that hydrogel and molecular gel (cry not only organogel) be mixed and made into can dissolve fat-soluble medicine but also can dissolve the gel of water soluble drug.Hydrogel is to be solvent with water, can dissolve water soluble drug, and molecular gel is to be solvent with the organic solvent, can dissolve fat-soluble medicine.Molecular gel is that the gel factor (some micromolecule organic compound) is passed through non-covalent interaction in non-aqueous media, spontaneously assembles, assembles orderly three-dimensional fiber network structure, makes the medium gelation.Reversible characteristics processing technology that molecular gel has heat is simple, and gelinite contains a large amount of organic solvents, be fit to the storage storehouse as lipophilic medicament, but molecular gel exists cohesiveness low, and viscosity is little, with the skin poor compliance, is not suitable for making shortcomings such as patch.Hydrogel water content height is fit to the storage storehouse as hydrophilic medicament, and is strong to the skin compliance, but is subjected to the influence of self property, and colloid poor plasticity, elasticity are little.In sum, be advantage in conjunction with these two kinds of gels, adopt the profit ampholytic gels factor that two kinds of gelinites are disperseed mixing, with the molecular gel is framework material, the patch substrate that hydrogel is made as sticky stuff, both high resilience forms have good compliance with skin, can peel off repeatedly, paste again, improve the drug loading of hydrophilic medicament and hydrophobic drug simultaneously again.Two kinds of gels twine staggered uniform distribution in substrate, by non-covalent bond form combinations such as Van der Waals forces, by fully contacting with skin, the both sexes medicine continues to see through skin through passage separately, enters blood circulation, the performance drug effect.
Bulbus Lilii has the nourishing YIN and moistening the lung cough-relieving, and the effect of tranquilizing by nourishing the heart is used for the fidgets due to deficiency palpitation with fear, insomnia and dreamful sleep etc.; The Poria promoting diuresis to eliminate damp pathogen, spleen-benefiting mind-tranquilizing is used for the malaise of deficiency of both the heart and spleen insufficiency of vital energy and blood; The Semen Ziziphi Spinosae the liver benefiting that nourishes heart is calmed the nerves, and arresting sweating is used for cardiopalmus, the insomnia of heart-liver blood deficiency; The Radix Polygalae mind tranquilizing and the heart calming eliminates the phlegm and has one's ideas straightened out, and the dissipation carbuncle main is gone into heart kidney, and gas and mind tranquilizing and the heart calming happily can lead to kidney qi again and strong will is not forgotten, and is restoring normal coordination between the heart and kidney, stabilizes the good merchantable brand of mind.Four kinds of medicines complement each other, and are the good recipes of Cure for insomnia.
Insomnia is often referred to the patient does not satisfy and influence the social function on daytime to the length of one's sleep and/or quality a kind of subjective experience.But the medicine of Cure for insomnia mostly is Western medicine greatly in the market, and the medicine of taking Cure for insomnia continually can stimulate gastric mucosa and cause drug dependence.
Summary of the invention
The objective of the invention is to advantage in conjunction with up-to-date molecular gel and hydrogel, both overcome the big shortcoming of existing oral formulations ubiquity side effect, avoided general aqueous gel poor plasticity, oil-base gel agent again shortcomings such as big, the easy pollution clothes of skin irritation.The invention provides a kind of to the Cure for insomnia effect remarkable and side effect is little, release slowly steadily, can long-term prescription, to little Transdermal absorption gel adhesive of skin irritation and preparation method thereof.
The technical solution used in the present invention is: gel adhesive of a kind of Cure for insomnia and preparation method thereof, it is made up of backing layer, adhesive-layer, protective layer, it is characterized in that the adhesive-layer in this patch mainly is made up of medicine, mixed gel and short penetrating agent.Said preparation is made up of following raw materials in weight portion: Bulbus Lilii 10-30 weight portions, Poria 10-30 weight portions, Semen Ziziphi Spinosae 10-40 weight portions, Radix Polygalae 5-30 weight portions, transdermal enhancer 8-20 weight portions, mixed gel 100-500 weight portions (molecular gel: hydrogel is 1:1-10); The weight percent content of total Chinese medicine extract is 1%-20% in the gel adhesive.The hydrogel of transdermal penetration agent, the molecular gel that contains the oil-soluble extract and hydrophilic extract adds with order respectively in proportion, and mix homogeneously is uniformly coated on the backing layer, the compound protective layer of going up, and after the extrusion modling, sterilization, stamping-out are made product.
Described drug molecule gel can be made as follows: 1%-30% gel factor is dissolved in the mixture of specific organic solvent or organic solvent.Medicine is dissolved in the organic solvent, adds a certain amount of gel factor then and mix, promptly get molecular gel.The gel factor that is adopted is divided into two classes, the first kind is simple tertiary amine and quaternary ammonium salt thereof such as lecithin, N, N, the two octadecane amine of N-three-octadecane amine, gallbladder steroid eicosane amine, methyl, dioctadecyl dimethyl ammonium chloride and cyclodextrin derivative class as: organic molecules such as beta-schardinger dextrin-, second class are derivative of fatty acid as 12-hydroxy octadecadienoic acid and associated salts, glyceryl monostearate etc.; Organic solvent comprises alkanes, arene, dimethyl sulfoxide (DMSO), acetonitrile, 1-propanol, 1-amylalcohol, 1-capryl alcohol, 1,2-propylene glycol, glycerol, silicone oil etc.
Described medicine hydrogel can be made as follows:
The first kind, 2%-15% sodium polyacrylate, 1%-30%PVP and 1%-20%CMC-Na pressed powder mix homogeneously are scattered in 15%-60% propylene glycol, the glycerol solvent, and mix homogeneously adds 40%-80% deionized water mix homogeneously promptly.The 0%-15% additive, additive comprises: Kaolin, starch, micropowder silica gel, aluminum chloride, Alumen, sodium alginate etc.
Second class, 0.1%-10% carbomer, 1%-20% sodium polyacrylate, 15%-40% glycerol, 30%-80% propylene glycol, 3%-15% ethanol, 5%-20% additive, additive comprises: Kaolin, starch, micropowder silica gel, citric acid, citric acid, ethanol, aluminum chloride, triethanolamine, ethyl hydroxybenzoate, ammonium stearate, disodium EDTA (EDTA-2Na), sodium benzoate, parabens or the like.
The above-mentioned described first kind prescription gel factor can only cooperate with first kind gel, and the second gellike factor and the second gellike agent cooperate.
Penetrating agent of the present invention comprises dimethyl sulfoxide and analog: dimethyl sulfoxide (DMSO); Azone compounds: laurocapram Azone; Alcohol compound: ethanol, propylene glycol, glycerol or the like.Described backing layer is non-woven fabrics or polyester film, and protective layer is paper or polyester film through release treatment.
Chinese crude drug extraction process of the present invention is not limited to extraction process by water, also can be that water is put forward other extraction processes such as organic solvent extractionprocess, alcohol extraction organic solvent extractionprocess and supercritical fluid extraction; Coating processes such as the also available blade coating molding of the preparation technology of patch.Gel adhesive of the present invention can be made arbitrary shape.
Process conditions:
A extract drugs technology
(a) get a certain amount of Bulbus Lilii, Poria coarse powder, water is 65 ℃ of following reflux, extract, 2 times, and solvent volume is respectively 15 times and 10 times of amounts, and the time is respectively 4h and 2h.Extracting solution is concentrated into 1/5 times of amount, with 30% ethanol precipitation of 4 times of amounts, standing over night, sucking filtration, precipitation drying for standby.
(b) get a certain amount of Semen Ziziphi Spinosae, the alcohol reflux with 80% 2 times, ethanol consumption be respectively 8 times, 7 times, and the time is respectively 3h and 2h.Decompression recycling ethanol, extractum is standby.
(c) get the coarse powder of a certain amount of Radix Polygalae, the alcohol reflux with 70% 2 times with the ethanol of 8 times of amounts, extracts 3h for the first time, for the second time with 6 times of amount ethanol, and extraction 2h, filtration, merging filtrate, concentrating under reduced pressure is to the extractum of certain volume, and is standby.
The preparation technology of B, patch:
(a) preparing process of profit ampholytic gels:
The first kind: get a certain amount of sodium polyacrylate, PVP and CMC-Na pressed powder and add in the agitator, heat 20-90 ℃, be scattered in propylene glycol, the glycerol solvent, mix homogeneously, add required organic solvent and the fat-soluble medicine extract mixing of molecular gel after adding deionized water and water soluble drug mix homogeneously, after slowly mixing after the adding mixed gel factor, progressively reduce to room temperature, form the profit ampholytic gels.
Second class: get in a certain amount of carbomer, sodium polyacrylate, glycerol, propylene glycol, ethanol, the additive adding agitator, heat 20-90 ℃, behind the mix homogeneously, add the water soluble drug extract, add required organic solvent of molecular gel and fat-soluble medicine extract again, mixing is after slowly mixing after the adding mixed gel factor, progressively reduce to room temperature, form the profit ampholytic gels.
(b) preparation technology of paster
The drug matrices that is mixed is evenly coated on the backing layer non-woven fabrics, will covers on the medicine glue-line through the polyester protecting film that release treatment is crossed, enter the roller bearing extrusion modling, THICKNESS CONTROL is below 5mm.Stamping-out, screening, quality inspection, packing are carried out by specification in the sterilization back.
The specific embodiment
Below example by the specific embodiment, foregoing of the present invention is described in further detail, embodiment only is indicative, means that never it limits the scope of the invention by any way.But under the situation that does not break away from the above-mentioned technological thought of the present invention, the various replacements of making according to ordinary skill knowledge and habitual means or the modification of change include within the scope of the invention.
Embodiment:
Transdermal enhancer oleic acid, azone 8kg
Molecular gel 2.5% lecithin,
97.5% Semen Myristicae isopropyl ester 100kg
Hydrogel 8% sodium polyacrylate, 2% polyvinylpyrrolidone
2% sodium carboxymethyl cellulose, 20% propylene glycol,
20% glycerol, 48% deionized water 300kg
Bulbus Lilii extract 20kg
Poria extract 15kg
Semen Ziziphi Spinosae extract 10kg
Radix Polygalae extract 10kg
Preparation method:
Take by weighing the 24kg sodium polyacrylate, 6kg polyvinylpyrrolidone and 6kg sodium carboxymethyl cellulose pressed powder mix homogeneously, be scattered in the 60kg propylene glycol, in the 60kg glycerol solvent, mix homogeneously in agitator, add Bulbus Lilii extract 20kg, Poria extract 15kg and 144L deionized water, mix homogeneously, get 97.5kg Semen Myristicae isopropyl ester and place agitator, add the 10kg Semen Ziziphi Spinosae extract, the mixture of 10kg Radix Polygalae extract and 8kg oleic acid and azone, 60 ℃ of heated and stirred are to complete mixing, add 2.5kg lecithin, after slowly stirring with 120 rev/mins, cooling, temperature reduce to stop to stir after the room temperature leave standstill 5h gel.The drug gel substrate that is mixed is evenly sprayed cloth on the backing layer non-woven fabrics, will cover on the medicine glue-line through the polyester protecting film that release treatment is crossed, enter the roller bearing extrusion modling, THICKNESS CONTROL is below 5mm.Stamping-out is carried out by specification in the sterilization back, makes patch, and coefficient of losses 15% is pressed Chinese Pharmacopoeia patch standard through quality inspection qualification rate 85%.The certified products packing.
Respectively to hydrogel adhesive, oil-base gel agent, molecular gel agent, four kinds of gels of ampholytic gels patch from mouldability, first viscous force, peeling force, tough elastic force, seven performance indications of compliance of skin irritation, preparation stability, patient are investigated.Every definition standard is as follows.
Mouldability: four kinds of gels of equal in quality are coated on the non-woven fabrics uniformly the overall appearance of observing colloid, loosely organized degree.
First viscous force: the assay method according to the first viscous force of patch in (2005) second appendix XJ patches of Chinese Pharmacopoeia adhesive force algoscopy is measured comparison to four kinds of gels that are coated on the non-woven fabrics.
Peeling force: the assay method according to peel strength in (2005) second appendix XJ patches of Chinese Pharmacopoeia adhesive force algoscopy is measured comparison to four kinds of gels that are coated on the non-woven fabrics.
Tough elasticity: coating on the non-woven fabrics circular glass sheet of placing identical size on four kinds of gel-type vehicles, a 20g counterweight is put by sheet central authorities, after the pressure relief, observes gel shape recovery situation and compares.
Skin irritation: observe animal intact skin single and repeatedly contact gel the local excitation reaction that is produced.(300g ± 20g), male and female half and half are divided into 8 groups, 5-6 every group to choose healthy albino guinea-pig.24h is with Cavia porcellus spinal column both sides unhairing before administration, check whether skin of unhairing has wound, apply ointment or plaster in the left and right sides of every Cavia porcellus the respectively gel of same dose is observed single-dose and is removed the situation that erythema and edema appear in skin in 1h, 24h behind the gel, 48h, the 72h.Repeatedly apply ointment or plaster more than the week, observe again a week after stopping, the redness of observed and recorded skin every day and edema situation and smear the position whether pigmentation, situation such as hemorrhage are arranged.
Stability: placed at ambient temperature 1 month, the character of observing each gel changes situation.
Patient's compliance: select some normal adults, stick four kinds of gels respectively, compare from situations such as the sensation of skin, degree easy to use.
Four kinds of various performance comparison results of gel
Annotate: +++for well; ++ in; + for poor
Claims (7)
1. gel adhesive of Cure for insomnia and preparation method thereof; it is characterized in that: it is made up of backing layer, adhesive-layer, protective layer; adhesive-layer is mixed and made into by Chinese medicine extract and molecular gel, hydrogel, transdermal enhancer; the weight portion proportioning is: Bulbus Lilii 10-30 weight portions; Poria 10-30 weight portions, Semen Ziziphi Spinosae 10-40 weight portions, Radix Polygalae 5-30 weight portions; transdermal enhancer 8-20 weight portions, mixed gel 100-500 weight portions (molecular gel: hydrogel is 1:1-10).
2. according to gel adhesive of the described Cure for insomnia of claim 1 and preparation method thereof, it is characterized in that: described molecular gel is formed and percentage by weight is: the gel factor 1%-30%, solvent or their mixture 50%-90%.The gel factor comprises the tertiary amine of ad hoc structure and quaternary amines organic compound thereof such as lecithin, N, N, N-three-octadecane amine, gallbladder steroid eicosane amine, the two octadecane amine of methyl, dioctadecyl dimethyl ammonium chloride; Organic molecules such as cyclodextrin derivative class such as beta-schardinger dextrin-; Derivative of fatty acid such as 12-hydroxy octadecadienoic acid and associated salts thereof, glyceryl monostearate, glyceryl tristearate, tripalmitin etc.Solvent comprises alkanes, arene, dimethyl sulfoxide (DMSO), acetonitrile, 2-ethoxy ethanol, 1-propanol, 1-amylalcohol, 1-capryl alcohol, 1,2-propylene glycol, glycerol, silicone oil, 14/isopropyl palmitate etc.
3. according to gel adhesive of the described Cure for insomnia of claim 1 and preparation method thereof, it is characterized in that: the composition of described hydrogel and percentage by weight are water-soluble base, water-insoluble substrate or their mixture 5%-30%, solvent 50%-90%, additive 1%-10%.Water-soluble base and non-aqueous substrate comprise polypropylene acid, sodium polyacrylate, carbomer resin, polyvinylpyrrolidone, sodium carboxymethyl cellulose, methylcellulose, polyvinyl alcohol and/or their mixture of various models; Additive comprises Kaolin, starch, micropowder silica gel, aluminum chloride, Alumen, sodium alginate etc.; Solvent comprises deionized water, propylene glycol, glycerol, ethanol and/or their mixture.
4. according to gel adhesive of the described Cure for insomnia of claim 1 and preparation method thereof, it is characterized in that: described penetrating agent comprises dimethyl sulfoxide and analog, azone class, alcohol compound, volatile oil and/or their mixture.
5. according to gel adhesive of the described Cure for insomnia of claim 1 and preparation method thereof, it is characterized in that: described backing layer is non-woven fabrics or polyester film, and protective layer is paper or polyester film through release treatment.
6. according to gel adhesive of the described Cure for insomnia of claim 1 and preparation method thereof, it is characterized in that: described preparation process comprises:
1) pressed powder of water intaking gel water-soluble base, non-aqueous substrate or their mixture places agitator, adds alcohols solvent, additive, deionized water and water soluble drug extract, mix homogeneously.Solvent and the fat-soluble medicine extract of getting molecular gel place agitator, add the gel factor, and 30 ℃ of-90 ℃ of heated and stirred are progressively reduced to room temperature and formed gel to mix homogeneously, and are standby.
2) drug matrices that will be mixed is uniformly coated on the backing layer non-woven fabrics, will cover on the medicine glue-line through the polyester protecting film that release treatment is crossed.Stamping-out, screening, quality inspection, packing are carried out by specification in the sterilization back.
7. according to gel adhesive of the described Cure for insomnia of claim 1 and preparation method thereof, it is characterized in that: preparation technology is spreading formation process, extrusion modling or spray mo(u)lding technology.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2007100604660A CN101468138A (en) | 2007-12-28 | 2007-12-28 | Gel patch for treating insomnia and method for preparing the same |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2007100604660A CN101468138A (en) | 2007-12-28 | 2007-12-28 | Gel patch for treating insomnia and method for preparing the same |
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| CN101468138A true CN101468138A (en) | 2009-07-01 |
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| CNA2007100604660A Pending CN101468138A (en) | 2007-12-28 | 2007-12-28 | Gel patch for treating insomnia and method for preparing the same |
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Cited By (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102302211A (en) * | 2011-07-26 | 2012-01-04 | 姜建国 | Health-care beverage |
| CN102688378A (en) * | 2012-06-04 | 2012-09-26 | 黄芸 | Traditional Chinese medicine oral liquid for relieving insomnia and preparation method for oral liquid |
| CN102716360A (en) * | 2012-06-20 | 2012-10-10 | 李良 | Cortex albiziae Chinese medicine decoction for relieving insomnia and preparation method |
| CN104069335A (en) * | 2014-07-17 | 2014-10-01 | 江苏东博生物医药有限公司 | Medicine composition capable of improving sleep quality and preparation method of medicine composition as well as application of medicine composition |
| CN104706768A (en) * | 2015-03-12 | 2015-06-17 | 施敬东 | Patch capable of calming nerves and helping sleep and preparation method of patch |
| CN105011129A (en) * | 2014-04-29 | 2015-11-04 | 赛珂睿德生物医药科技(上海)有限公司 | Functional food with sleep improving effect |
| CN105233060A (en) * | 2015-11-11 | 2016-01-13 | 曹涛 | Traditional Chinese medicine foot patch capable of promoting sleep and improving constipation |
| CN108815363A (en) * | 2018-09-05 | 2018-11-16 | 河南羚锐制药股份有限公司 | A kind of Chinese herbs paste of relieving mental strain and helping sleep |
| CN113262260A (en) * | 2021-06-05 | 2021-08-17 | 亳州益智健康产业有限公司 | Cold compress gel for treating insomnia |
| CN115813816A (en) * | 2022-09-16 | 2023-03-21 | 江苏集萃功能材料研究所有限公司 | Mild gel mask and application thereof |
| CN116785374A (en) * | 2023-06-08 | 2023-09-22 | 成都中医药大学 | Traditional Chinese medicine effervescent tablet for soothing nerves and aiding sleep and preparation method thereof |
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2007
- 2007-12-28 CN CNA2007100604660A patent/CN101468138A/en active Pending
Cited By (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102302211B (en) * | 2011-07-26 | 2013-05-01 | 姜建国 | Health-care beverage |
| CN102302211A (en) * | 2011-07-26 | 2012-01-04 | 姜建国 | Health-care beverage |
| CN102688378A (en) * | 2012-06-04 | 2012-09-26 | 黄芸 | Traditional Chinese medicine oral liquid for relieving insomnia and preparation method for oral liquid |
| CN102688378B (en) * | 2012-06-04 | 2014-01-08 | 黄芸 | Traditional Chinese medicine oral liquid for relieving insomnia and preparation method for oral liquid |
| CN102716360A (en) * | 2012-06-20 | 2012-10-10 | 李良 | Cortex albiziae Chinese medicine decoction for relieving insomnia and preparation method |
| CN105011129A (en) * | 2014-04-29 | 2015-11-04 | 赛珂睿德生物医药科技(上海)有限公司 | Functional food with sleep improving effect |
| CN104069335A (en) * | 2014-07-17 | 2014-10-01 | 江苏东博生物医药有限公司 | Medicine composition capable of improving sleep quality and preparation method of medicine composition as well as application of medicine composition |
| CN104706768A (en) * | 2015-03-12 | 2015-06-17 | 施敬东 | Patch capable of calming nerves and helping sleep and preparation method of patch |
| CN105233060A (en) * | 2015-11-11 | 2016-01-13 | 曹涛 | Traditional Chinese medicine foot patch capable of promoting sleep and improving constipation |
| CN108815363A (en) * | 2018-09-05 | 2018-11-16 | 河南羚锐制药股份有限公司 | A kind of Chinese herbs paste of relieving mental strain and helping sleep |
| CN113262260A (en) * | 2021-06-05 | 2021-08-17 | 亳州益智健康产业有限公司 | Cold compress gel for treating insomnia |
| CN115813816A (en) * | 2022-09-16 | 2023-03-21 | 江苏集萃功能材料研究所有限公司 | Mild gel mask and application thereof |
| CN115813816B (en) * | 2022-09-16 | 2024-05-28 | 江苏集萃功能材料研究所有限公司 | Mild gel mask and application thereof |
| CN116785374A (en) * | 2023-06-08 | 2023-09-22 | 成都中医药大学 | Traditional Chinese medicine effervescent tablet for soothing nerves and aiding sleep and preparation method thereof |
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Open date: 20090701 |