CN108653245B - Hydrogel transdermal patch containing various pure plant extract oils and preparation method thereof - Google Patents

Abstract

The invention provides a hydrogel transdermal patch containing various pure plant extract oils and a preparation method thereof, the hydrogel transdermal patch comprises a gel layer, an isolation film on the surface of the gel layer and backing cloth on the back of the gel layer, wherein the gel layer is prepared from the following raw materials in parts by weight: pure plant extract oil: 14-30 parts; carbomer 940: 2-5 parts; NP 800: 4-7 parts; glycerol: 30-50 parts; aluminum glycollate: 4-9 parts; PVPK 90: 10-30 parts; tartaric acid: 2-9 parts of a solvent; ethanol: 20-30 parts of a solvent; EDTA-2 Na: 6-16 parts; pure water: 80-100 parts. The hydrogel transdermal patch of the invention improves the degree of application of the hydrogel transdermal patch, has firm adhesion, high colloid stability and more delicate product, and increases the content of plant components while increasing the viscosity of the hydrogel transdermal patch. By adding various blood-activating, swelling-diminishing and pain-relieving plants into the raw materials of the gel layer, the fever and blood circulation-promoting performance of the product is improved, and the application effect and the application time of the product are improved.

Description

Hydrogel transdermal patch containing various pure plant extract oils and preparation method thereof

Technical Field

The invention belongs to the field of traditional Chinese medicine patches, and particularly relates to a hydrogel transdermal patch containing various pure plant extract oils and a preparation method thereof.

Background

The hydrogel plaster is a novel external application agent with high technological content, wide application range and convenient use in the world at present. In the early seventies, medical hydrogel patches have been developed in Japan, Europe and other countries, and with the continuous development of the medical industry, the new dosage forms have been developed in China in recent years. The hydrogel plaster substrate has large drug-loading rate, strong moisture retention, good compatibility with skin, aging resistance, repeated uncovering and pasting, stopping drug administration at any time, accurate dosage, balanced blood concentration, no peak valley phenomenon, reduced toxic and side effects, no organic solvent pollution in industrial production and accordance with the medical GMP standard and the national environmental protection requirement. Compared with the traditional rubber type external plaster, the hydrogel plaster has the following advantages: the skin-friendly deodorant has good biocompatibility, affinity, air permeability and sweat resistance and is not easy to be allergic; the water-soluble macromolecular gel matrix is adopted, so that no residue is left after use, and clothes are not polluted; the moisturizing performance is good, the skin keratinocyte can be quickly hydrated, the transdermal absorption of plants is facilitated, and the effect is quick; the air permeability is good, and the use is comfortable; the patch has no irritation and sensitization to skin, can be repeatedly removed and attached, and does not affect curative effect; the capacity is large, the adhesive force of the common rubber plaster is reduced rapidly and even the adhesiveness is lost when the addition amount of the plant exceeds 2 percent, and the drug capacity of the hydrogel matrix can reach 15 to 30 percent and can reach 65 percent at most.

Most of the existing gel pastes in the market adopt a single-molecular low-density material such as PVPK30 or carbomer 930 as a cross-linking body of gel layer molecules, because the molecular weight is small, the cross-linking reaction is insufficient and the stability is poor, the added medicine is single, and the addition amount is low, the finished paste is easy to cause low medicine component containing amount, the blood circulation promoting effect is poor, the degree of adhesion is low, and the gel pastes are easy to fall off.

Disclosure of Invention

In view of the above, the present invention is directed to a hydrogel transdermal patch containing various pure plant extract oils and a preparation method thereof, so as to solve the above problems.

In order to achieve the purpose, the technical scheme of the invention is realized as follows:

a hydrogel transdermal patch containing various pure plant extract oils comprises a gel layer, an isolation film on the surface of the gel layer and backing cloth on the back of the gel layer, wherein the gel layer is prepared from the following raw materials in parts by weight:

pure plant extract oil: 14-30 parts;

carbomer 940: 2-5 parts;

NP 800: 4-7 parts;

glycerol: 30-50 parts;

aluminum glycollate: 4-9 parts;

PVPK 90: 10-30 parts;

tartaric acid: 2-9 parts of a solvent;

ethanol: 20-30 parts of a solvent;

EDTA-2 Na: 6-16 parts;

pure water: 80-100 parts.

Further, the pure plant extract oil comprises the following components in parts by weight:

white mustard seed extract oil: 4-10 parts;

extracting oil from cinnamon: 1-3 parts;

extracting oil from ginger: 1-3 parts;

saffron extraction oil: 2-4 parts;

mint extraction oil: 1-4 parts;

extracting oil from yellow mustard seeds: 5-6 parts.

Further, the gel layer is prepared from the following raw materials in parts by weight:

pure plant extract oil: 20 parts of (1);

carbomer 940: 5 parts of a mixture;

NP 800: 5 parts of a mixture;

glycerol: 45 parts of (1);

aluminum glycollate: 8 parts of a mixture;

PVPK 90: 20 parts of (1);

tartaric acid: 6 parts of (1);

ethanol: 22 parts of (A);

EDTA-2 Na: 12 parts of (1);

pure water: 95 parts of the components.

Further, the pure plant extract oil comprises the following components in parts by weight:

white mustard seed extract oil: 4.5 parts;

extracting oil from cinnamon: 2 parts of (1);

extracting oil from ginger: 2.2 parts of;

saffron extraction oil: 3 parts of a mixture;

mint extraction oil: 2.8 parts;

extracting oil from yellow mustard seeds: 5.5 parts.

Further, the isolating film is a medical release film.

Further, the back lining cloth is medical water-repellent spunlace cloth.

The preparation method of the hydrogel transdermal patch containing various pure plant extract oils comprises the following steps:

s1: adding tartaric acid into pure water, uniformly stirring, adding PVPK90, stirring, and uniformly stirring again to obtain a mixture A;

s2: adding glycerol into NP800, stirring, adding dihydroxyaluminum glycerol, stirring, adding EDTA-2Na, stirring uniformly, and stirring uniformly to obtain a mixture B;

s3: adding cortex Cinnamomi extract oil, rhizoma Zingiberis recens extract oil, stigma croci Sativi extract oil, herba Menthae extract oil, semen Brassicae Junceae extract oil, and semen Sinapis Albae extract oil into ethanol, and stirring to obtain mixture C;

s4: adding carbomer 940 into pure water, stirring, standing for 2-3 hr until carbomer 940 is completely swelled in water, and stirring to obtain mixture D;

s5: and (3) stirring the mixture A and the mixture D, adding the mixture B and the mixture C after uniformly stirring until the mixture A, the mixture B, the mixture C and the mixture D are all fused and subjected to crosslinking reaction to obtain a gel layer, starting the machine to coat the gel layer on the surface of the backing cloth, attaching the isolating membrane to the surface of the gel layer, and cutting to obtain a finished product.

The formulation efficacy principle of the gel layer in the invention is as follows:

1. white mustard seed extract oil: resolving phlegm and expelling retained fluid; disperse stagnation and relieve swelling; fullness in the chest and hypochondriac pain; numbness of limbs; joint swelling and pain; damp phlegm flowing and injecting; deep rooted carbuncle of yin type with pyogenic infections. It can be used for treating acute mastitis, breast cancer, mammary gland pain, apoplexy, numbness and pain of limbs, tinea pedis, carbuncle of yin type, toxic swelling, and traumatic injury.

2. Extracting oil from cinnamon: it can be used for treating rheumatism, lumbago due to cold arthralgia, thoracic obstruction, and dorsal furuncle. The pungent herbs with the action of dispersing warm and unblocking, can promote the circulation of qi and blood, dispel cold and alleviate pain. It is indicated for arthralgia due to wind-cold-dampness, especially for lumbago due to arthralgia due to cold.

3. Extracting oil from ginger: has the main functions of promoting blood circulation by removing blood stasis, activating the whole body mental tissue, relieving muscular soreness and arthralgia, and diminishing inflammation and easing pain.

4. Saffron extraction oil: the saffron oil is aromatic oil obtained by distilling saffron, and has the functions of promoting blood circulation to disperse blood clots, dredging meridian, cooling blood, detoxicating, diminishing inflammation, relieving pain, etc.

5. Mint extraction oil: aromatic drugs, flavoring drugs and carminative drugs. Can be used for skin or mucosa to produce cool feeling to relieve discomfort and pain. It can be used for treating neuralgia, skin pruritus, erythra, eczema, etc.

6. The main effects of the extracted oil of the yellow mustard seed are as follows:warm and pungent taste. Has the efficacies of moistening lung and reducing phlegm, relieving swelling and pain, warming spleen and stomach and dispelling cold, inducing diuresis and removing blood stasis, dredging channels and collaterals and eliminating swelling and toxin, and is mainly used for treating numbness of limbs, arthralgia, traumatic injury and the like which can promote blood circulation and remove blood stasis 5. carbomer: has a chemical formula of C₃H₄O₂) The neutralized carbomer is an excellent gel matrix and has important applications of thickening, suspending and the like, the process is simple, the stability is good, and the neutralized carbomer is widely applied to emulsion, cream and gel. The product is a high molecular polymer of acrylic acid bonded allyl sucrose or pentaerythritol allyl ether. The carboxylic acid group (-COOH) content should be 56.0% -68.0% calculated on the dried product.

NP 800: the molecular formula is (C)₃H₃NaO₂) n, the source and the preparation method are obtained by neutralizing acrylic acid or acrylic ester to form salt. Due to the different molecular weights of the polymers, their properties and uses vary. The thickener has physical and chemical properties, and is colorless and transparent water-soluble resin with molecular weight of millions. At about pH4, the polymer easily coagulated and dissolved at pH 2.5. Is easily dissolved in an aqueous sodium hydroxide solution, but precipitates in water containing calcium hydroxide, magnesium hydroxide, and the like. The application and dosage of the product can be used as thickening binder for medicine and cosmetics. It is commonly used in external lotions and gel formulations. After being dispersed evenly in water. Neutralizing the pH value of 6-10 with triethanolamine or inorganic base to generate the required viscosity. The main component of the safety agent is sodium polyacrylate, and no harm is found when the application test is carried out on skin.

8. Glycerol: alias glycerol, formula C₃H₈O₃Glycerol is the backbone component of the triglyceride molecule. Relative density 1.26362, melting point 17.8 ℃ and boiling point 290.0 ℃ (decomposition). Refractive index 1.4746. Flash point (open cup) 176 ℃.

9. Aluminum dihydroxylate, its chemical name is dihydroxyaminoacetic acid aluminum, its molecular formula is C₆H₁₂AlN₃O₁₂Molecular weight 345.1539, CAS number 41354-48-7.

PVPK90 with the chemical name polyvinylpyrrolidone and the molecular formula of (C)₆H₉NO), CAS number 900-39-8, white or off-white powder and clear aqueous solution, readily soluble in water and various organic solvents, PVP-K90 is used industrially as dispersant, film former, thickener, lubricant and binder.

11. Tartaric acid, chemical name is 2, 3-dihydroxy succinic acid, molecular formula is C4H6O6, CAS number is 87-69-4, 526-83-0, tartaric acid is colorless transparent crystal or white crystal powder, and has no odor, extremely acidic taste, and relative density of 1.7598. The melting point is 168-170 ℃. Is easily soluble in water, methanol and ethanol, slightly soluble in diethyl ether, and insoluble in chloroform.

12. Alcohol: chemical name of ethanol, purity 95%, can form azeotropic mixture (containing 4.43% of water) with water, and azeotropic point is 78.15 ℃. The relative density (d204) was 0.789. The melting point was-114.1 ℃. The boiling point was 78.5 ℃. Refractive index (n20D) was 1.361. The structural formula of ethanol is C₂H₅OH is commonly called alcohol, and is flammable, volatile, colorless and transparent liquid at normal temperature and normal pressure.

EDTA-2Na, the Chinese name being disodium edetate, of formula: c₁₀H₁₄N₂Na₂O₈·2H₂O, disodium edetate, also known as EDTA, is a good complexing agent in chemistry, having six coordinating atoms, forming complexes known as chelates, which are often used in coordination titration, typically to determine the content of metal ions.

Compared with the prior art, the hydrogel transdermal patch containing various pure plant extract oils has the following advantages:

the hydrogel transdermal patch increases the density of molecules in a gel layer, and simultaneously uses two high polymer materials of PVPk90 and carbomer 940 to ensure that the two high polymer materials are fully fused. The adhesive degree of the hydrogel transdermal patch is improved, the patch is firm, the colloid stability is high, the product is more delicate, and the content of plant components is increased while the viscosity of the hydrogel transdermal patch is increased. The heating and blood activating performance of the product is improved by adding various blood activating, swelling subsiding and pain relieving plants, namely the purified oil of white mustard seed, yellow mustard seed, ginger, saffron crocus, cinnamon, mint and the like into the raw materials of the gel layer, so that the application effect and the application time of the product are greatly improved.

The hydrogel transdermal patch of the invention comprises: the biocompatibility with skin is good, and the hydrophilic polymer matrix has air permeability, sweat resistance, no sensitization and no irritation; secondly, the drug loading is large, the drug release performance is good, the affinity with the skin is strong, the hydration function of the horny layer can be improved, and the transdermal absorption of the drug is facilitated; thirdly, the percutaneous absorption controlled release technology is applied to ensure that the blood concentration is stable and the drug effect is durable; fourthly, the use is convenient, the clothes are not polluted, the washing is easy, and the repeated sticking can be realized; gasoline and other organic solvents are not used in the production process, so that the pollution to the environment is avoided.

Detailed Description

Unless defined otherwise, technical terms used in the following examples have the same meanings as commonly understood by one of ordinary skill in the art to which the present invention belongs. The test reagents used in the following examples, unless otherwise specified, are all conventional biochemical reagents; the experimental methods are conventional methods unless otherwise specified.

The present invention will be described in detail with reference to examples.

Example 1

A hydrogel transdermal patch containing various pure plant extract oils comprises a gel layer, an isolation film on the surface of the gel layer and backing cloth on the back of the gel layer, wherein the gel layer is prepared from the following raw materials in parts by weight: pure plant extract oil: 100g of the total weight of the mixture; carbomer 940: 25g of the total weight of the mixture; NP 800: 25g of the total weight of the mixture; glycerol: 225g of the total weight of the mixture; aluminum glycollate: 40g of the total weight of the mixture; PVPK 90: 100g of the total weight of the mixture; tartaric acid: 30g of the total weight of the mixture; ethanol: 110 g; EDTA-2 Na: 60g of the total weight of the mixture; pure water: 475 g. Wherein the pure plant extract oil comprises the following components in weight g: white mustard seed extract oil: 22.5 g; extracting oil from cinnamon: 10g of a mixture; extracting oil from ginger: 11g of a reaction solution; saffron extraction oil: 15g of the total weight of the mixture; mint extraction oil: 14g of a mixture; extracting oil from yellow mustard seeds: 27.5 g.

The preparation method of the hydrogel transdermal patch containing various pure plant extract oils comprises the following steps:

s1: adding tartaric acid into pure water, uniformly stirring, adding PVPK90, stirring, and uniformly stirring again to obtain a mixture A;

s2: adding glycerol into NP800, stirring, adding dihydroxyaluminum glycerol, stirring, adding EDTA-2Na, stirring uniformly, and stirring uniformly to obtain a mixture B;

s3: adding cortex Cinnamomi extract oil, rhizoma Zingiberis recens extract oil, stigma croci Sativi extract oil, herba Menthae extract oil, semen Brassicae Junceae extract oil, and semen Sinapis Albae extract oil into ethanol, and stirring to obtain mixture C;

s4: adding carbomer 940 into pure water, stirring uniformly, standing for 2 hours until carbomer 940 is completely swelled in water, and stirring uniformly again to obtain a mixture D;

s5: and (3) stirring the mixture A and the mixture D, adding the mixture B and the mixture C after uniformly stirring until the mixture A, the mixture B, the mixture C and the mixture D are all fused and subjected to crosslinking reaction to obtain a gel layer, starting the machine to coat the gel layer on the surface of the backing cloth, attaching the isolating membrane to the surface of the gel layer, and cutting to obtain a finished product.

Example 2

A hydrogel transdermal patch containing various pure plant extract oils comprises a gel layer, an isolation film on the surface of the gel layer and backing cloth on the back of the gel layer, wherein the gel layer is prepared from the following raw materials in parts by weight: pure plant extract oil: 90g of the total weight of the mixture; carbomer 940: 10g of a mixture; NP 800: 25g of the total weight of the mixture; glycerol: 160g of a mixture; aluminum glycollate: 36g of a mixture; PVPK 90: 110 g; tartaric acid: 20g of the total weight of the mixture; ethanol: 120g of a mixture; EDTA-2 Na: 50g of the total weight of the mixture; pure water: 400 g. The pure plant extract oil comprises the following components in parts by weight: white mustard seed extract oil: 20g of the total weight of the mixture; extracting oil from cinnamon: 10g of a mixture; extracting oil from ginger: 10g of a mixture; saffron extraction oil: 15g of the total weight of the mixture; mint extraction oil: 10g of a mixture; extracting oil from yellow mustard seeds: 25 g.

The preparation method of the hydrogel transdermal patch containing various pure plant extract oils comprises the following steps:

s1: adding tartaric acid into pure water, uniformly stirring, adding PVPK90, stirring, and uniformly stirring again to obtain a mixture A;

s2: adding glycerol into NP800, stirring, adding dihydroxyaluminum glycerol, stirring, adding EDTA-2Na, stirring uniformly, and stirring uniformly to obtain a mixture B;

s3: adding cortex Cinnamomi extract oil, rhizoma Zingiberis recens extract oil, stigma croci Sativi extract oil, herba Menthae extract oil, semen Brassicae Junceae extract oil, and semen Sinapis Albae extract oil into ethanol, and stirring to obtain mixture C;

s4: adding carbomer 940 into pure water, stirring uniformly, standing for 2 hours until carbomer 940 is completely swelled in water, and stirring uniformly again to obtain a mixture D;

s5: and (3) stirring the mixture A and the mixture D, adding the mixture B and the mixture C after uniformly stirring until the mixture A, the mixture B, the mixture C and the mixture D are all fused and subjected to crosslinking reaction to obtain a gel layer, starting the machine to coat the gel layer on the surface of the backing cloth, attaching the isolating membrane to the surface of the gel layer, and cutting to obtain a finished product.

Example 3

A hydrogel transdermal patch containing various pure plant extract oils comprises a gel layer, an isolation film on the surface of the gel layer and backing cloth on the back of the gel layer, wherein the gel layer is prepared from the following raw materials in parts by weight: pure plant extract oil: 70g of a mixture; carbomer 940: 10g of a mixture; NP 800: 20g of the total weight of the mixture; glycerol: 150g of the total weight of the mixture; aluminum glycollate: 20g of the total weight of the mixture; PVPK 90: 50g of the total weight of the mixture; tartaric acid: 10g of a mixture; ethanol: 100g of the total weight of the mixture; EDTA-2 Na: 30g of the total weight of the mixture; pure water: 400 g. Wherein the pure plant extract oil comprises the following components in weight g: white mustard seed extract oil: 20g of the total weight of the mixture; extracting oil from cinnamon: 5g of the total weight of the mixture; extracting oil from ginger: 5g of the total weight of the mixture; saffron extraction oil: 10g of a mixture; mint extraction oil: 5g of the total weight of the mixture; extracting oil from yellow mustard seeds: 25 g.

The preparation method of the hydrogel transdermal patch containing various pure plant extract oils comprises the following steps:

s1: adding tartaric acid into pure water, uniformly stirring, adding PVPK90, stirring, and uniformly stirring again to obtain a mixture A;

s2: adding glycerol into NP800, stirring, adding dihydroxyaluminum glycerol, stirring, adding EDTA-2Na, stirring uniformly, and stirring uniformly to obtain a mixture B;

s3: adding cortex Cinnamomi extract oil, rhizoma Zingiberis recens extract oil, stigma croci Sativi extract oil, herba Menthae extract oil, semen Brassicae Junceae extract oil, and semen Sinapis Albae extract oil into ethanol, and stirring to obtain mixture C;

s4: adding carbomer 940 into pure water, stirring uniformly, standing for 2 hours until carbomer 940 is completely swelled in water, and stirring uniformly again to obtain a mixture D;

s5: and (3) stirring the mixture A and the mixture D, adding the mixture B and the mixture C after uniformly stirring until the mixture A, the mixture B, the mixture C and the mixture D are all fused and subjected to crosslinking reaction to obtain a gel layer, starting the machine to coat the gel layer on the surface of the backing cloth, attaching the isolating membrane to the surface of the gel layer, and cutting to obtain a finished product.

Example 4

A hydrogel transdermal patch containing various pure plant extract oils comprises a gel layer, an isolation film on the surface of the gel layer and backing cloth on the back of the gel layer, wherein the gel layer is prepared from the following raw materials in parts by weight: pure plant extract oil: 125 g; carbomer 940: 20g of the total weight of the mixture; NP 800: 25g of the total weight of the mixture; glycerol: 240 g; aluminum glycollate: 30g of the total weight of the mixture; PVPK 90: 125 g; tartaric acid: 35g of a soybean milk powder; ethanol: 130g of the total weight of the mixture; EDTA-2 Na: 60g of the total weight of the mixture; pure water: 440 g. The pure plant extract oil comprises the following components in parts by weight: white mustard seed extract oil: 40g of the total weight of the mixture; extracting oil from cinnamon: 10g of a mixture; extracting oil from ginger: 15g of the total weight of the mixture; saffron extraction oil: 15g of the total weight of the mixture; mint extraction oil: 15g of the total weight of the mixture; extracting oil from yellow mustard seeds: 30 g.

The preparation method of the hydrogel transdermal patch containing various pure plant extract oils comprises the following steps:

s1: adding tartaric acid into pure water, uniformly stirring, adding PVPK90, stirring, and uniformly stirring again to obtain a mixture A;

s2: adding glycerol into NP800, stirring, adding dihydroxyaluminum glycerol, stirring, adding EDTA-2Na, stirring uniformly, and stirring uniformly to obtain a mixture B;

s3: adding cortex Cinnamomi extract oil, rhizoma Zingiberis recens extract oil, stigma croci Sativi extract oil, herba Menthae extract oil, semen Brassicae Junceae extract oil, and semen Sinapis Albae extract oil into ethanol, and stirring to obtain mixture C;

s4: adding carbomer 940 into pure water, stirring uniformly, standing for 2 hours until carbomer 940 is completely swelled in water, and stirring uniformly again to obtain a mixture D;

s5: and (3) stirring the mixture A and the mixture D, adding the mixture B and the mixture C after uniformly stirring until the mixture A, the mixture B, the mixture C and the mixture D are all fused and subjected to crosslinking reaction to obtain a gel layer, starting the machine to coat the gel layer on the surface of the backing cloth, attaching the isolating membrane to the surface of the gel layer, and cutting to obtain a finished product.

Example 5

A hydrogel transdermal patch containing various pure plant extract oils comprises a gel layer, an isolation film on the surface of the gel layer and backing cloth on the back of the gel layer, wherein the gel layer is prepared from the following raw materials in parts by weight: pure plant extract oil: 150g of the total weight of the mixture; carbomer 940: 25g of the total weight of the mixture; NP 800: 35g of a soybean milk powder; glycerol: 250g of the total weight of the mixture; aluminum glycollate: 45g of the total weight of the mixture; PVPK 90: 150g of the total weight of the mixture; tartaric acid: 40g of the total weight of the mixture; ethanol: 150g of the total weight of the mixture; EDTA-2 Na: 75g of the total weight of the mixture; pure water: 500 g. The pure plant extract oil comprises the following components in parts by weight: white mustard seed extract oil: 50g of the total weight of the mixture; extracting oil from cinnamon: 15g of the total weight of the mixture; extracting oil from ginger: 15g of the total weight of the mixture; saffron extraction oil: 20g of the total weight of the mixture; mint extraction oil: 20g of the total weight of the mixture; extracting oil from yellow mustard seeds: 30 g.

The preparation method of the hydrogel transdermal patch containing various pure plant extract oils comprises the following steps:

s1: adding tartaric acid into pure water, uniformly stirring, adding PVPK90, stirring, and uniformly stirring again to obtain a mixture A;

s2: adding glycerol into NP800, stirring, adding dihydroxyaluminum glycerol, stirring, adding EDTA-2Na, stirring uniformly, and stirring uniformly to obtain a mixture B;

s3: adding cortex Cinnamomi extract oil, rhizoma Zingiberis recens extract oil, stigma croci Sativi extract oil, herba Menthae extract oil, semen Brassicae Junceae extract oil, and semen Sinapis Albae extract oil into ethanol, and stirring to obtain mixture C;

s4: adding carbomer 940 into pure water, stirring uniformly, standing for 2 hours until carbomer 940 is completely swelled in water, and stirring uniformly again to obtain a mixture D;

s5: and (3) stirring the mixture A and the mixture D, adding the mixture B and the mixture C after uniformly stirring until the mixture A, the mixture B, the mixture C and the mixture D are all fused and subjected to crosslinking reaction to obtain a gel layer, starting the machine to coat the gel layer on the surface of the backing cloth, attaching the isolating membrane to the surface of the gel layer, and cutting to obtain a finished product.

Test example 1: formability test

The hydrogel transdermal patches obtained in examples 1-5 were subjected to a forming test, which specifically comprises the following steps:

the hydrogel transdermal patches obtained in examples 1-5 were placed in a constant temperature and humidity chamber with a temperature of 37 ℃ and a relative humidity of 64% for 30 minutes, taken out, and the test sample was fixed on a flat steel plate with a clamp, the inclination angle between the steel plate and the horizontal plane was 60 °, and left for 24 hours, and no sagging phenomenon on the surface of the hydrogel transdermal patch was observed, and the test results are shown in the following table:

group of	Test results
		Example 1	Without flowing
Example 2	Without flowing
		Example 3	Without flowing
Example 4	Without flowing
		Example 5	Without flowing

As can be seen from the above table, the hydrogel transdermal patch of the invention has no flow phenomenon on the surface and good forming property.

Test example 2: adhesion test

Each of the products of examples 1 to 5 was taken, and the cover liner was removed, and the paste was placed on the upper side of the center of a 15 DEG inclined plate, and the initial adhesion was measured according to the method for measuring adhesive force of a patch XII E in the first appendix of pharmacopoeia of the people's republic of China, 2010 edition (first method), and the ball number and specification of the steel ball were as defined in the measuring method: the larger the number of the ball, the larger the diameter, indicating a higher initial adhesion.

The adhesion of the products obtained in examples 1 to 5 of the present invention was determined by the above method and the results are shown in the following table:

as can be seen from the above table, the hydrogel transdermal patch of the invention has good adhesiveness, can stick to No. 12 steel balls at least and can stick to No. 28 steel balls at most.

Test example 3: detection of cream content

Test apparatus and instruments: an analytical balance (sensing quantity is 0.1mg), a measuring tape, a glass container with a cover, a beaker, an elbow or flat-head surgical forceps, an oven (temperature control precision is plus or minus 1 degree), a dryer (common) and water.

The operation method comprises the following steps:

(1) 1 sample of each of 3 examples was taken and measured to have a measurement area of 70cm²The lid liner was removed and precision weighed into a stationary beaker. Adding appropriate amount of water, boiling until the back lining is separated from the paste, taking out the back lining, washing with water until no paste remains on the back lining, and air drying;

(2) placing the sample into an oven and drying at 105 ℃ for 30 min;

(3) cooling in a dryer, airing the back lining, and weighing;

(4) the weight of the sample paste minus the weight of the backing is the paste weight.

The test results obtained by repeating the test of the sample patch three times are as follows:

sample (I)	Weight of sample paste	Weight of backing	Weight of paste	Size of sample paste
					Example 1	8.5g	1g	7.5g	70cm2
Example 2	8.3g	1g	7.3g	70cm2
					Example 3	8.4g	1g	7.4g	70cm2

The product of the invention contains the paste in an amount of 70cm²The average value is 7.4 g per 100cm²The content of (A) is 10.92g, and the content is checked per 100cm (second method) according to the requirement of plaster in the first appendix I (Chinese pharmacopoeia) of version 2010²The amount of the compound should not be less than 6.7 g. The content of the ointment of the invention is in line with and higher than the requirement standard of Chinese pharmacopoeia. Namely, the gel layer of the invention has the advantages of enough gram weight, high viscosity, more lasting pasting, more ideal effect, difficult shedding and better ductility. The patch is more comfortable to be attached.

Test example 4: pure plant extract oil loading

Instruments and appliances: analytical balance (sensing quantity 0.1mg), measuring scale, glass container with cover, beaker, elbow or flat head surgical forceps, oven (temperature control precision plus or minus 1 degree), dryer (common), water-oil separator

The operation method comprises the following steps:

(1) 1 sample of each of 3 examples was taken and measured to have a measurement area of 70cm²The lid liner was removed and precision weighed into a stationary beaker. Adding appropriate amount of water, boiling until the back lining is separated from the paste, taking out the back lining, washing with water until no paste remains on the back lining, and air drying;

(1) placing the sample into an oven and drying at 105 ℃ for 30 min;

(1) cooling in a dryer, airing the back lining, and weighing;

(1) the paste weight is obtained by subtracting the backing weight from the sample paste weight;

(1) heating the washed gel paste and water until the gel paste is completely dissolved;

(1) extracting the vegetable oil by using a water-oil separator, and placing the vegetable oil in a container for precise weighing.

The test results obtained by repeating six times of the gel paste test of the sample paste and the gel paste test in the existing market are as follows:

from the above table, the product of the invention has a 2 times higher plant extract content than that of the common gel patch in the market by comparing the plant extract content of the common gel patch with that of the common gel patch in the market. The product of the invention has the advantages of long-lasting drug effect and strong permeability due to large content of the plant extracts and the effective components in the gel, and can better play the roles of activating blood circulation, reducing swelling and relieving pain. Greatly shortens the application time and reduces the allergic rate. The plaster is more convenient for patients to use, is more effective to be stuck, and can quickly relieve pains.

Test example 5

The product of the invention is prepared into 10 samples, each 10 samples are pasted, 10 patients with various diseases are found, the total number of the patients is 10, the patients respectively suffer from rheumatism bone pain, traumatic injury, cervical spondylosis, scapulohumeral periarthritis, lumbocrural pain, numbness and swelling, synovitis and hyperplasia of mammary glands, and the specific using process and the effect are as follows:

name (I)

Disease part

Number of uses

Application time

Analgesic effect

Therapeutic effects

Integrated feedback

Zhang-a

Rheumatic osteodynia in knee joint

10 paste

20 days

Promoting blood circulation, eliminating dampness and relieving pain

Is effective

Has no allergy

Lie somewhere

Traumatic injury of elbow joint

10 paste

15 days

Detumescence, blood circulation promoting and pain relieving

Recovery method

No allergy and quick effect

Dong's somebody

Cervical spondylosis of cervical vertebra

10 paste

10 days

Promoting blood circulation and relieving pain

Recovery method

No allergy and quick effect

Zhang-a

Pain in the waist and legs

10 paste

20 days

Promoting blood circulation and relieving pain

Recovery method

No allergy and quick effect

Lie somewhere

Scapulohumeral periarthritis

10 paste

20 days

Promoting blood circulation and relieving pain

Recovery method

No allergy and quick effect

Chen (a certain)

Prolapse of lumbar intervertebral disc

10 paste

20 days

Promoting blood circulation and relieving pain

Has obvious effect

No allergy and quick effect

King of a certain

Swelling and pain due to sour sesame

10 paste

22 days

Promoting blood circulation and relieving pain

Recovery method

No allergy and quick effect

Shen somewhere

Synovitis (synovitis)

10 paste

13 days

Detumescence and transforming effusion

The effect is obvious

No allergy and quick effect

Zhu someone

Arthralgia pain

10 paste

18 days

Promoting blood circulation and relieving pain

The effect is not obvious

Has no allergy

Feng (Chinese character of 'feng')

Hyperplasia of mammary glands

10 paste

15 days

Promoting blood circulation and detumescence

Recovery method

Has no allergy

As can be seen from the clinical data in the table, the product of the invention has the advantages of pain relieving rate of 90%, cure rate of 60%, effective rate of 90% and allergy rate of 0 case. Compared with the experiment of 10 parts of common plaster, the common plaster (medicinal powder coating plaster or decocted plaster) sold on the market has the pain relieving rate of 45%, the cure rate of 33%, the effective rate of 45% and the allergy rate of 3%. Compared with the prior art, the purified vegetable oil in the product has higher effective concentration, large colloid content and stronger permeability, and particularly, the peppermint oil has the effects of refreshing, inducing resuscitation and relieving pain and mainly can open skin pores. The hydrogel patch softens the horny layer of the skin, so that the cinnamon oil, the white mustard oil and the yellow mustard seed oil effectively and quickly permeate to play a role in activating blood, and meanwhile, the ginger oil and the saffron oil have the functions of activating blood and dissolving stasis, diminishing inflammation and relieving pain, so that the pain of a pain part of a patient can be quickly and effectively relieved, and further, the product has the treatment effects of good pain relieving effect, high treatment success rate and low allergy rate.

The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents, improvements and the like that fall within the spirit and principle of the present invention are intended to be included therein.

Claims (6)

1. A hydrogel transdermal patch containing various pure plant extract oils is characterized in that: the adhesive comprises a gel layer, an isolation film on the surface of the gel layer and backing cloth on the back of the gel layer, wherein the gel layer is prepared from the following raw materials in parts by weight:

pure plant extract oil: 14-30 parts;

carbomer 940: 2-5 parts;

NP 800: 4-7 parts;

glycerol: 30-50 parts;

aluminum glycollate: 4-9 parts;

PVPK 90: 10-30 parts;

tartaric acid: 2-9 parts of a solvent;

ethanol: 20-30 parts of a solvent;

EDTA-2 Na: 6-16 parts;

pure water: 80-100 parts of a binder;

the pure plant extract oil comprises the following components in parts by weight:

white mustard seed extract oil: 4-10 parts;

extracting oil from cinnamon: 1-3 parts;

extracting oil from ginger: 1-3 parts;

saffron extraction oil: 2-4 parts;

mint extraction oil: 1-4 parts;

extracting oil from yellow mustard seeds: 5-6 parts.

2. The hydrogel transdermal patch containing a plurality of pure plant-extracted oils according to claim 1, wherein: the gel layer is prepared from the following raw materials in parts by weight:

pure plant extract oil: 20 parts of (1);

carbomer 940: 5 parts of a mixture;

NP 800: 5 parts of a mixture;

glycerol: 45 parts of (1);

aluminum glycollate: 8 parts of a mixture;

PVPK 90: 20 parts of (1);

tartaric acid: 6 parts of (1);

ethanol: 22 parts of (A);

EDTA-2 Na: 12 parts of (1);

pure water: 95 parts of the components.

3. The hydrogel transdermal patch containing a plurality of pure plant-extracted oils according to claim 1, wherein: the pure plant extract oil comprises the following components in parts by weight:

white mustard seed extract oil: 4.5 parts;

extracting oil from cinnamon: 2 parts of (1);

extracting oil from ginger: 2.2 parts of;

saffron extraction oil: 3 parts of a mixture;

mint extraction oil: 2.8 parts;

extracting oil from yellow mustard seeds: 5.5 parts.

4. The hydrogel transdermal patch containing a plurality of pure plant-extracted oils according to claim 1, wherein: the isolating film is a medical release film.

5. The hydrogel transdermal patch containing a plurality of pure plant-extracted oils according to claim 1, wherein: the back lining cloth is medical water repellent spunlace cloth.

6. The method for preparing a hydrogel transdermal patch containing a plurality of pure plant-extracted oils according to any one of claims 1 to 5, wherein: the method comprises the following steps:

s1: adding tartaric acid into pure water, uniformly stirring, adding PVPK90, stirring, and uniformly stirring again to obtain a mixture A;

s2: adding glycerol into NP800, stirring, adding dihydroxyaluminum glycerol, stirring, adding EDTA-2Na, stirring uniformly, and stirring uniformly to obtain a mixture B;

s3: adding cortex Cinnamomi extract oil, rhizoma Zingiberis recens extract oil, stigma croci Sativi extract oil, herba Menthae extract oil, semen Brassicae Junceae extract oil, and semen Sinapis Albae extract oil into ethanol, and stirring to obtain mixture C;

s4: adding carbomer 940 into pure water, stirring, standing for 2-3 hr until carbomer 940 is completely swelled in water, and stirring to obtain mixture D;

s5: and (3) stirring the mixture A and the mixture D, adding the mixture B and the mixture C after uniformly stirring until the mixture A, the mixture B, the mixture C and the mixture D are all fused and subjected to crosslinking reaction to obtain a gel layer, starting the machine to coat the gel layer on the surface of the backing cloth, attaching the isolating membrane to the surface of the gel layer, and cutting to obtain a finished product.