CN110664967B

CN110664967B - Black plaster for softening hardness to dissipate stagnation, relieving swelling and pain and preparation process thereof

Info

Publication number: CN110664967B
Application number: CN201911130612.1A
Authority: CN
Inventors: 孟庆广
Original assignee: Individual
Current assignee: Individual
Priority date: 2019-11-19
Filing date: 2019-11-19
Publication date: 2021-07-09
Anticipated expiration: 2039-11-19
Also published as: CN110664967A

Abstract

The invention relates to a medicine and a preparation method thereof, namely a black plaster for softening hardness to dissipate stagnation, reducing swelling and relieving pain and a preparation process thereof, and the black plaster is characterized in that: the raw material medicines of the medicine are 30-50 parts of centipede, 25-35 parts of toad venom, 25-35 parts of radix bupleuri, 20-30 parts of salvia miltiorrhiza, 20-30 parts of radix scrophulariae, 20-30 parts of blackberry lily, 15-25 parts of radix curcumae, 15-25 parts of earthworm, 10-20 parts of scorpion, 200-300 parts of minium and 400-600 parts of castor oil according to the weight part ratio. The preparation process of the medicine comprises the following steps: the preparation method comprises making the raw materials into unguent by conventional process, removing fire toxin with solution composed of ethanol, glacial acetic acid, and water, and spreading the unguent on cloth. The beneficial effects are as follows: the transdermal absorption effect is enhanced, the traditional process is improved, and the black plaster formula for softening hardness, dissipating stagnation, reducing swelling and relieving pain is obtained, wherein the black plaster formula has high absorption rate, good drug effect and small irritation.

Description

Black plaster for softening hardness to dissipate stagnation, relieving swelling and pain and preparation process thereof

Technical Field

The invention relates to a medicine and a preparation method thereof, in particular to a black plaster for softening hardness, dissipating stagnation, reducing swelling and relieving pain and a preparation process thereof.

Background

Qi, blood, essence and body fluids are the basic substances constituting the human body, but abnormal distribution and metabolism will result in accumulation of pathological products, including phlegm and fluid, blood stasis, mass and calculi. The elimination of pathological products is an important link in the treatment of diseases, and the treatment method is different according to the reason for the formation of pathological products and different accumulation modes. The traditional Chinese Mongolian treatment methods include blood circulation promoting and blood stasis removing method, meridian passage dredging and activating method, and hardness softening and stagnation dissipating method. In clinical practice and literature records, the hardness-softening and stagnation-resolving method usually adopts a method of treating symptoms and root causes by external application, treating root causes by internal application and combining internal and external application, and treating both symptoms and root causes.

The black plaster is an external preparation for skin application as a traditional plaster, has the effects of drawing out poison, relieving swelling and pain, promoting blood circulation to remove blood stasis, softening hardness to dissipate stagnation and the like, and has the advantages of higher drug-loading rate, longer action and wider clinical application. The medicines in the black plaster enter the skin by penetration, and the effects of diminishing inflammation, relieving pain, promoting blood circulation to remove blood stasis, clearing and activating the channels and collaterals, inducing resuscitation and penetrating bones, dispelling wind and cold and the like are achieved, so the curative effect of the black plaster is directly influenced by the transdermal absorption effect of the black plaster. At present, methods for improving the transdermal absorption effect of the black plaster comprise pharmaceutical methods such as a penetration enhancer and a novel drug carrier, physical methods such as an electroporation method, an ion introduction method, an ultrasonic method and a laser penetration promotion method, and a meridian point transdermal drug delivery method, but the methods or the preparation process are complex, or easily generate stimulation to skin, or are complex to operate and not easy to popularize and use. Therefore, the research of utilizing the own medicinal components in the black plaster formula to promote the transdermal absorption effect of the medicament is an important way for the black plaster which is an ancient formulation to be popularized and used and to have great luster.

In addition, the disadvantages of the black plaster such as easy irritation to skin and difficult quality control are also problems to be solved by drug research personnel.

Disclosure of Invention

The invention aims to develop a black plaster formula which has no stimulation, good transdermal effect, lasting effect, consolidated curative effect, difficult relapse and controllable quality and is used for softening hardness, resolving hard mass, relieving swelling and pain.

The invention also aims to provide a preparation process of the black plaster for softening hardness to dissipate stagnation, and relieving swelling and pain.

The above purpose is realized by the following technical scheme: provides a black plaster for softening hardness, resolving hard mass, relieving swelling and pain, which is characterized in that:

the black plaster comprises, by weight, 30-50 parts of centipede, 25-35 parts of toad venom, 25-35 parts of radix bupleuri, 20-30 parts of salvia miltiorrhiza, 20-30 parts of radix scrophulariae, 20-30 parts of blackberry lily, 15-25 parts of radix curcumae, 15-25 parts of earthworm, 10-20 parts of scorpion, 200-300 parts of minium and 400-600 parts of castor oil.

The preferable scheme of the formula comprises the following raw material medicines in parts by weight: 40 parts of centipede, 30 parts of toad venom, 30 parts of radix bupleuri, 25 parts of salvia miltiorrhiza, 25 parts of radix scrophulariae, 25 parts of blackberry lily, 20 parts of radix curcumae, 20 parts of earthworm, 15 parts of scorpion, 250 parts of minium and 500 parts of castor oil.

The preparation process of the black plaster comprises the following steps:

pulverizing Plumbum preparatium, and sieving with 120 mesh sieve;

crushing the toad venom, and sieving with a 120-mesh sieve to obtain fine materials for later use;

heating castor oil to 35-50 deg.C at 18-26 deg.C, adding Scolopendra, bupleuri radix, Saviae Miltiorrhizae radix, radix scrophulariae, rhizoma Belamcandae, radix Curcumae, Lumbricus, and Scorpio into the castor oil, stirring, heating to 210-240 deg.C, frying until the surface is dark brown and the interior is brown, filtering with 120 mesh sieve, and removing residue to obtain medicinal oil;

decocting the medicinal oil at 300-330 deg.C to form dripping pills, stopping heating,

adding Plumbum Preparatium immediately, stirring, mixing to obtain unguent, spraying cold water to solidify unguent, soaking unguent in solution composed of ethanol, glacial acetic acid, and water (ethanol: glacial acetic acid: water =1:2.5: 4) for 24 hr, placing the unguent in container, melting with slow fire, adding fine materials, stirring, and uniformly spreading unguent on cloth.

30-50 parts of centipede, 25-35 parts of toad venom, 25-35 parts of radix bupleuri, 20-30 parts of radix salviae miltiorrhizae, 20-30 parts of radix scrophulariae, 20-30 parts of blackberry lily, 15-25 parts of radix curcumae, 15-25 parts of earthworm, 10-20 parts of scorpion, 200-300 parts of minium and 400-600 parts of castor oil, and 15-25 parts of fructus forsythiae, 15-25 parts of crude drugs and 20-30 parts of ground beetle are added.

The preparation process of the black plaster comprises the following steps: pulverizing Plumbum preparatium, and sieving with 120 mesh sieve;

mixing Bufonis venenum and the rest materials, pulverizing, and sieving with 120 mesh sieve to obtain fine powder;

heating castor oil to 35-50 deg.C at 18-26 deg.C, adding Scolopendra, bupleuri radix, Saviae Miltiorrhizae radix, radix scrophulariae, rhizoma Belamcandae, radix Curcumae, Lumbricus, fructus forsythiae, Scorpio, and Eupolyphaga Seu Steleophaga, stirring, heating castor oil to 210-240 deg.C, frying the materials until the surface is dark brown and the interior is dark yellow, filtering with 120 mesh sieve, and removing residue to obtain medicinal oil;

continuously decocting the medicinal oil at 300-330 deg.C to a degree of dripping water into beads, stopping heating, immediately adding Plumbum Preparatium, stirring, and mixing to obtain unguent; spraying cold water to solidify the ointment, soaking the ointment in a solution of ethanol, glacial acetic acid, and water (ethanol: glacial acetic acid: water =1:2.5: 4) for 24 hr, melting with slow fire, adding fine materials, stirring, and spreading the ointment on cloth.

30-50 parts of centipede, 25-35 parts of toad venom, 25-35 parts of radix bupleuri, 20-30 parts of radix salviae miltiorrhizae, 20-30 parts of radix scrophulariae, 20-30 parts of blackberry lily, 15-25 parts of radix curcumae, 15-25 parts of earthworm, 10-20 parts of scorpion, 200-300 parts of minium, 400-600 parts of castor oil, 15-25 parts of fructus forsythiae, 15-25 parts of crude drug and 20-30 parts of ground beetle, and 15-25 parts of frankincense and 15-25 parts of honeysuckle are added.

The preparation process of the black plaster comprises the following steps:

pulverizing Plumbum preparatium, and sieving with 120 mesh sieve;

mixing Olibanum, Bufonis venenum and the rest materials, pulverizing, and sieving with 120 mesh sieve to obtain fine powder;

heating castor oil to 35-50 ℃ in an environment with the temperature of 18-26 ℃, adding centipede, radix bupleuri, radix salviae miltiorrhizae, radix scrophulariae, blackberry lily, radix curcumae, ground beetle, earthworm, fructus forsythiae and scorpion, stirring, frying the medicinal materials until the surfaces of the medicinal materials are withered yellow, adding honeysuckle, stirring, continuously heating the castor oil to 210-240 ℃, frying the medicinal materials until the surfaces of the medicinal materials are dark brown and the interiors of the medicinal materials are scorched yellow, filtering by using a 120-mesh sieve, and removing dregs to obtain medicinal oil for later use;

continuously decocting the medicinal oil at 300-330 deg.C to form dripping pills, stopping heating, immediately adding Plumbum Preparatium, stirring, mixing to obtain ointment, spraying cold water to solidify the ointment, soaking the ointment in a solution of ethanol, glacial acetic acid, and water (ethanol: glacial acetic acid: water =1:2.5: 4) for 24 hr, placing the ointment in a container, melting with slow fire, adding fine materials, stirring, and uniformly spreading the ointment on a cloth.

30-50 parts of centipede, 25-35 parts of toad venom, 25-35 parts of radix bupleuri, 20-30 parts of radix salviae miltiorrhizae, 20-30 parts of radix scrophulariae, 20-30 parts of blackberry lily, 15-25 parts of radix curcumae, 15-25 parts of earthworm, 15-25 parts of frankincense, 10-20 parts of scorpion, 200-300 parts of minium, 400-600 parts of castor oil, 15-25 parts of fructus forsythiae, 15-25 parts of crude drug, 20-30 parts of ground beetle and 15-25 parts of honeysuckle are added, and 15-25 parts of laurel seed and 15-25 parts of fennel are added.

The preparation process of the black plaster comprises the following steps:

pulverizing Plumbum preparatium, and sieving with 120 mesh sieve;

heating castor oil to 35-50 ℃ in an environment with the temperature of 18-26 ℃, adding radix bupleuri, radix salviae miltiorrhizae, radix scrophulariae, blackberry lily, radix curcumae, centipede, ground beetle, earthworm, fructus forsythiae, scorpion and laurel, stirring, frying the medicinal materials until the surfaces of the medicinal materials are withered yellow, adding honeysuckle and fennel, stirring, continuously heating the castor oil to 210-240 ℃, frying the medicinal materials until the surfaces of the medicinal materials are dark brown and the interiors of the medicinal materials are scorched yellow, filtering the medicinal materials by using a 120-mesh sieve, and removing dregs to obtain medicinal oil for later use;

The invention has the beneficial effects that: the black plaster formula for softening hardness, dissipating stagnation, relieving swelling and pain with high absorption rate and good drug effect is obtained through research by enhancing the transdermal absorption effect of the medicine through the components of the medicine formula, and meanwhile, the preparation method of the black plaster with small irritation, low side effect, safety, effectiveness and controllable quality is obtained through improvement of the traditional black plaster preparation process.

Detailed Description

The first embodiment:

200-300 parts of minium is taken according to parts by weight, crushed and sieved by a 120-mesh sieve for later use, 25-35 parts of toad venom is taken, crushed and sieved by the 120-mesh sieve for later use, 400-600 parts of castor oil is taken and heated to 35-50 ℃ under the environment of 18-26 ℃, 30-50 parts of centipede, 25-35 parts of radix bupleuri, 20-30 parts of salvia miltiorrhiza, 20-30 parts of radix scrophulariae, 20-30 parts of blackberry lily, 15-25 parts of radix curcumae, 15-25 parts of earthworm and 10-20 parts of scorpion are added and stirred, the castor oil is continuously heated to 210-240 ℃, the medicinal materials are fried to be dark brown on the surface and burnt yellow inside, the medicinal materials are filtered by the 120-mesh sieve, the dregs of the medicinal materials are removed, medicinal oil is obtained for later use, the medicinal oil is continuously prepared into the degree of dripping water and beading at the temperature of 300-330 ℃, the minium is immediately added, the minium is continuously stirred and uniformly mixed to obtain ointment, cold water is sprayed to solidify the ointment, and the ointment is immersed in ethanol, Adding glacial acetic acid and water (ethanol: glacial acetic acid: water =1:2.5: 4) into the solution for 24 hr, then placing the ointment into a container, melting with slow fire, adding the fine materials, stirring, and uniformly spreading the ointment on an ointment cloth.

250 parts of Plumbum preparatium by weight are preferably selected, the materials are crushed and sieved by a 120-mesh sieve for standby, 30 parts of toad venom are selected, crushed and sieved by a 120-mesh sieve to obtain fine materials for standby, 500 parts of castor oil is selected and heated to 35-50 ℃ under the environment of 18-26 ℃, 40 parts of centipede, 30 parts of radix bupleuri, 25 parts of radix salviae miltiorrhizae, 25 parts of radix scrophulariae, 25 parts of blackberry lily, 20 parts of radix curcumae, 20 parts of earthworm and 15 parts of scorpion are added, the castor oil is stirred and continuously heated to 210-240 ℃, the medicinal materials are fried to be dark brown on the surface and scorched inside, the medicinal materials are filtered by a 120-mesh sieve to remove medicinal residues to obtain medicinal oil for standby, the medicinal oil is continuously decocted to the degree of dripping water into beads at 300-330 ℃, the fire is stopped, the Plumbum preparatium is immediately added, the medicinal oil is continuously stirred and uniformly mixed to obtain medicinal ointment, cold water is sprayed to solidify the medicinal ointment, and is immersed in a solution consisting of ethanol, glacial acetic acid and water (ethanol: glacial acetic acid: water =1:2., then, the ointment is taken out and placed in a container, the mixture is melted by slow fire, the fine materials are added, the mixture is stirred evenly, and the ointment is evenly spread on the ointment cloth. Is applied to affected parts and replaced every 48 hours.

Animal experiments were performed with reference to relevant literature.

First, skin safety test

1. Preparing a black plaster:

250g of minium is taken, crushed and sieved by a 120-mesh sieve for later use, 30g of toad venom is taken, crushed and sieved by a 120-mesh sieve to obtain fine materials for later use, 500g of castor oil is taken and heated to 35-50 ℃ under the environment of 18-26 ℃, 40g of centipede, 30g of radix bupleuri, 25g of radix salviae miltiorrhizae, 25g of radix scrophulariae, 25g of blackberry lily, 20g of radix curcumae, 20g of earthworm and 15g of scorpion are added into the fine materials, the castor oil is stirred, the castor oil is continuously heated to 210-240 ℃, the medicinal materials are fried to be dark brown on the surface and burnt yellow inside, the medicinal materials are filtered by a 120-mesh sieve, dregs are removed to obtain medicinal oil, the medicinal oil is reserved for later use, the medicinal oil is continuously decocted to be beaded at the temperature of 300-330 ℃, the medicinal oil is immediately added with minium and stirred without stopping heating, the stirring to obtain ointment, the ointment is sprayed with cold water to enable the ointment to be solidified, and the ointment is immersed in a solution consisting of ethanol, glacial acetic acid and water (ethanol, glacial acetic, then, placing the ointment into a container, melting with slow fire, adding the fine materials, stirring, and uniformly spreading the ointment on an ointment cloth.

2. Acute toxicity test of skin

Test animals and treatments: 32 SPF-grade guinea pigs with weight of 200-260 g and 16 male and female animals were randomly divided into A, B, C, D groups of 8 animals each. Group a is the intact skin high dose group, group B is the intact skin low dose group, group C is the broken skin high dose group, and group D is the broken skin low dose group. The guinea pigs were depilated 24h prior to dosing on both sides of the spinal column, at a range of 6cm x 6cm (approximately 10% of the body surface area) around the spinal column.

The test method comprises the following steps: the black plaster is cut into the size of the hair removal area of the guinea pig. Group A the cut black plaster was applied directly to the hair removal area of guinea pigs (equivalent to 60 times the adult dose); b group, after removing half of the medicine from the cut black plaster, the black plaster is pasted on the hair removal part of the guinea pig (equivalent to 30 times of the adult dose); group C, before application, a disinfected large-size needle is used for making # -shaped scratches on the skin of the tested parts on the two sides of the back of the guinea pig, the scratched cuticle can be obviously seen by naked eyes and has slight bleeding degree, the distance between the scratches is about 0.5cm, and then the cut black plaster is directly applied to the depilated part of the guinea pig (which is equivalent to 60 times of the dosage of an adult); group D: before application, a disinfected large-size needle is used for making a # -shaped scratch on the skin of a tested part on two sides of the back of a guinea pig, the scratched stratum corneum is obviously visible with naked eyes and slight bleeding is caused, the distance between the scratches is about 0.5cm, and then the sheared black plaster is applied to a depilated part of the guinea pig (which is equivalent to 30 times of the dosage of an adult) after half of the medicine is removed. A. B, C, D after administration for 48h, the plaster is removed from four groups of guinea pigs, and the behavior, skin, weight, hair, diet, and death of guinea pigs are continuously observed for 7 days.

And (4) observing results: no death occurred in any of the four groups of guinea pigs after 7 days, and no abnormal phenomena were observed in body weight, skin, hair, diet, activity of limbs, and behavior pattern. The black plaster shows that no acute toxic reaction occurs when the guinea pigs are externally used under the dosage.

3. Skin irritation test

Test animals and treatments: 20 SPF-grade guinea pigs with weight of 200-260 g and 10 male and female animals were randomly divided into A, B groups of 10 animals each. Group A is the intact skin administration group, and group B is the damaged skin administration group. The guinea pigs were depilated 24h prior to dosing on both sides of the spinal column, at a range of 6cm x 6cm (approximately 10% of the body surface area) around the spinal column. The left depilatory area of the spine of each guinea pig in the group A is used as an intact skin irritation test area, and the right depilatory area of the spine is used as an intact skin irritation blank area; the left depilated area of the spine of each guinea pig in group B was used as the damaged skin irritation test area, and the right depilated area of the spine was used as the damaged skin irritation blank area.

Preparation method of guinea pig damaged skin: the skin of the tested part on both sides of the back of the guinea pig is scratched like a # with a sterilized large-size needle, so that the scratched stratum corneum and slight bleeding can be obviously seen by naked eyes, and the distance between the scratches is about 0.5 cm.

The test method comprises the following steps: cutting black plaster into half size of hair removal area of guinea pigs, and applying on A, B test zones of two groups of guinea pigs; plaster cloth with corresponding size and without medicine is pasted on the blank area as a control. After 48h, the black plaster and the plaster cloth are removed, and the condition of erythema, edema and the like at the hairless area of the guinea pig and the recovery condition of the hairless area of the guinea pig are observed for 1h, 24h, 48h and 72h respectively. The test was continued 3 times as described above.

And (4) observing results: in the first test, no erythema and edema are observed in 1h, 24h, 48h and 72h of the application part of 10 black guinea pig plasters and a control blank application area in the group A, and the black guinea pig plasters are nonirritating according to skin anaphylaxis stage division and a skin irritation test evaluation table; in the group B, no erythema and edema were observed in 1h, 24h, 48h and 72h in the black plaster application part of 2 guinea pigs and the control blank application area, slight erythema and edema occurred in 1h after the black plaster application part of 3 guinea pigs was applied, moderate erythema and edema occurred in 1h after the black plaster application part of 5 guinea pigs was applied, no erythema and edema occurred in the control blank application area, and it was known from the skin allergy progression division and skin irritation test evaluation table that the black plaster application part and the control blank application area were moderate irritation. Compared with the observation results of the second test and the third test with the first test, no obvious difference exists.

The results show that: the black plaster in this example is non-irritating to intact skin and moderately irritating to broken skin.

4. Skin allergy test

SPF-grade guinea pigs 24 were taken and depilated 24h prior to testing, approximately 3cm by 3cm on each side of the back. Guinea pigs were randomly divided into A, B, C groups of 8 animals each, half male and half female, according to body weight and sex. A group is black plaster, B group is plaster cloth, and C group is positive sensitizer, namely 0.2ml of 1%2, 4-dinitrochlorobenzene. After a duration of 6h, the patch was removed A, B, C from the back of all three guinea pigs and wiped clean with an alcohol cotton ball. Sensitization exposure was repeated 3 times in the same manner at 7d and 14 d. After the third sensitization, the guinea pigs were observed for the presence or absence of skin allergy at 0h, 24h, 48h, and 72h, respectively.

And (4) observing results: 7 of the guinea pigs in the group C have obvious anaphylactic reaction at different time, 4 of the guinea pigs have mild edema, and the skin of the administration area of the guinea pigs in the group A and the group B is glossy and smooth, smooth and wrinkle-free, and has no erythema or edema, which proves that the black plaster has no anaphylactic reaction through the skin anaphylactic test of the guinea pigs. A. B, C No serious allergic reactions such as asthma, unstable stance or shock were observed in guinea pigs.

The results show that: the black plaster in this example was not sensitive to skin.

Second, pharmacodynamic test

The test method comprises the following steps: taking 32 New Zealand rabbits, half of each of the male and female, shearing two hind limbs of the rabbits 24h before the experiment, wherein the left hind limb is a medicine leg, and the right hind limb is a control leg. The rabbit hind limb local soft tissue injury hematoma model is caused by falling from a height of 1m by a weight of 50g, and the model has no fracture and no skin fracture. Randomly dividing rabbits into A, B groups, wiping the injury part of right hind limb of rabbits with alcohol without any treatment in group A, applying black plaster with corresponding size to the injury part of left hind limb of rabbits, and changing the medicine every 48 h; and B, wiping the injury of the right hind limb of the rabbit with alcohol, and then wiping the injury of the left hind limb of the rabbit with the hibirine ointment, wherein the medicine is changed once every 8 hours. After the self-modeling, the affected limb ecchymosis and swelling performance are observed every day for 21 days during the raising and treatment period.

And (4) observing results: after 3d, the swelling of the left hind limb (coated with black plaster) of 16 rabbits in the group A is basically subsided, ecchymosis is rarely seen under the skin, the nodules of the injured part of the left hind limb of the rabbit are reduced after 3d, and after 15d, the nodules basically disappear after 7d, and 13 left hind limbs of 16 rabbits are basically recovered to be normal; the right hind limb (alcohol only swabbed) of 16 rabbits remained swollen after 7d, with all subcutaneous ecchymoses present and nodules still evident.

After 10 days, the swelling of the left hind limb (wiping the hibirine ointment) of 16 rabbits in the group B is basically subsided, subcutaneous ecchymosis becomes shallow, and the left hind limb of 9 rabbits is basically recovered to be normal after 20 days; after 10 days, the right hind limb (only alcohol is wiped) of 16 rabbits still swelled, subcutaneous ecchymosis is all present, and nodules are still evident.

The results show that: the black plaster in the embodiment has obvious drug effects on traumatic injury, blood stasis retention, obstruction of tendons and vessels, swelling and pain, and is superior to a control drug, namely the ertapeline ointment.

Third, process test

Fire toxin is a low molecular decomposition product generated in the oxidative polymerization of oil at high temperature, such as aldehyde, ketone, lower fatty acid, etc. These "dry" components can cause local irritation to the skin, and allergic phenomena such as itching, redness, swelling, ulceration, blistering, etc. The fire toxin problem limits the clinical application of the black plaster to a great extent. The production process adopts water soaking, water spraying, water frying and other steps to eliminate fire toxin. The water immersion method for removing fire toxin requires repeated kneading and water replacement, requires 7 to 10 days, is time-consuming and labor-consuming, and is likely to breed microorganisms; in the process of fire toxin removal by a water spraying method, a large amount of dense smoke is generated when cold water is poured into a high-temperature oil pan, the air environment is seriously influenced, and splashed oil easily scalds the skin, so that the method is not suitable for large-scale production; although the fire toxin removing effect is obvious by combining the water-frying method and the water-soaking method, the process is more complicated.

In the embodiment, the black plaster is soaked in a solution consisting of ethanol, glacial acetic acid and water (the ethanol is glacial acetic acid: the water is =1:2.5: 4) to remove fire toxin for 24 hours, so that irritant low-grade decomposition products (aldehyde, ketone, low-grade fat and the like) generated by oxidative decomposition during boiling under a high-temperature condition can be dissolved in the solution, and macromolecular nonpolar active ingredients of the black plaster cannot be dissolved, so that the irritant ingredients of the black plaster can be removed without influencing the curative effect.

Based on consulting a large amount of documents, the inventor of the improved preparation process (process II) in the embodiment selects and mixes a plurality of solvents such as water, methanol, ethanol, isopropanol, glacial acetic acid, diethyl ether, propylene oxide, methyl acetate, ethyl acetate, acetone and the like in a laboratory through a large amount of animal tests, and finally determines the ratio of ethanol to glacial acetic acid according to the principle of no toxicity, little irritation and no influence on the treatment effect: water =1:2.5:4 as a solution for removing fire toxin of the black plaster.

The traditional preparation process (process I): 250g of minium is taken, crushed and sieved by a 120-mesh sieve for later use, 30g of toad venom is taken, crushed and sieved by a 120-mesh sieve to obtain fine materials for later use, 500g of castor oil is taken and heated to 35-50 ℃ under the environment of 18-26 ℃, 40g of centipede, 30g of radix bupleuri, 25g of salvia miltiorrhiza, 25g of radix scrophulariae, 25g of blackberry lily, 20g of radix curcumae, 20g of earthworm and 15g of scorpion are added and stirred, the castor oil is continuously heated to 210-240 ℃, the medicinal materials are fried to be dark brown on the surface and burnt yellow inside, the medicinal materials are filtered by a 120-mesh sieve, dregs are removed to obtain medicinal oil, the medicinal oil is kept for later use, the medicinal oil is continuously decocted to be beaded at the temperature of 300-330 ℃, the plaster is immediately added with minium and continuously stirred to obtain ointment, the ointment is poured into cold water to be coagulated into blocks, the blocks are immersed into the cold water for 7 days, water is changed for 1 time every day, placing the ointment in a container, melting with slow fire, adding the fine materials, stirring, and uniformly spreading the ointment on an ointment cloth.

An improved preparation process (process II):

68 volunteer patients were selected and randomly and evenly divided into I and II groups, each group had 34 patients, and the general data comparison of the two groups of patients had no statistical significance (P > 0.05) and were comparable. The black plaster prepared by the process I and the process II is used for treating the patient suffering from the volunteer, is replaced every 48 hours and is continuously used for 10 days. The skin irritation effect is shown in table 1.

TABLE 1 skin irritation Effect Table

"+" indicates irritation at the skin application site and "-" indicates no irritation or insignificant irritation at the skin application site.

As a result: in group I, 23 patients had skin irritation, wherein 12 patients had neck, 7 patients had chest, and 4 patients had limbs; in group I, 11 patients had no skin irritation, and the parts applied were four limbs. No skin irritation was observed in any of the 34 patients in group II, wherein the applied part was neck in 15 patients, breast in 9 patients, and four limbs in 10 patients. The results show that the improved preparation process (process II) has better skin irritation response than the traditional preparation process (process I).

The second embodiment:

200-300 parts of minium is taken according to the weight part, crushed and sieved by a 120-mesh sieve for standby, 25-35 parts of toad venom and 15-25 parts of crude drugs are taken, mixed, crushed and sieved by the 120-mesh sieve to obtain fine materials for standby, 400-600 parts of castor oil are taken and heated to 35-50 ℃ under the environment of 18-26 ℃, 30-40 parts of centipede, 25-35 parts of radix bupleuri, 20-30 parts of salvia miltiorrhiza, 20-30 parts of radix scrophulariae, 20-30 parts of blackberry lily, 20-30 parts of ground beetle, 15-25 parts of radix curcumae, 15-25 parts of earthworm, 15-25 parts of forsythia and 10-20 parts of scorpion are added, stirring is carried out, the castor oil is continuously heated to 210-240 ℃, the medicinal materials are fried to be dark brown on the surface and burnt yellow inside, the 120-mesh sieve is used for filtering, dregs are removed, medicinal oil is obtained for standby, the medicinal oil is continuously prepared into the degree of dripping water at the temperature of 300-330 ℃, fire is stopped, the minium is immediately added, and stirred continuously, mixing to obtain ointment, spraying cold water to solidify the ointment, soaking the ointment in a solution of ethanol, glacial acetic acid, and water (ethanol: glacial acetic acid: water =1:2.5: 4) for 24 hr, placing the ointment in a container, melting with slow fire, adding fine materials, stirring, and spreading the ointment on a cloth.

Selecting 250 parts of minium according to parts by weight, crushing, sieving by a 120-mesh sieve for later use, taking 30 parts of toad venom and 20 parts of unprepared medicines, mixing, crushing, sieving by a 120-mesh sieve to obtain fine materials, taking 500 parts of castor oil, heating to 35-50 ℃ under the environment of 18-26 ℃, adding 40 parts of centipede, 30 parts of radix bupleuri, 25 parts of radix salviae miltiorrhizae, 25 parts of radix scrophulariae, 25 parts of blackberry lily, 25 parts of ground beetle, 20 parts of radix curcumae, 20 parts of earthworm, 20 parts of fructus forsythiae and 15 parts of scorpion, stirring, continuously heating the castor oil to 210-240 ℃, frying the medicines to the surface of which is dark brown and the interior of which is dark yellow, filtering by a 120-mesh sieve, removing dregs of the medicines to obtain medicinal oil, preparing for later use, continuously decocting the medicinal oil to the degree of minium beading at the temperature of 300-330 ℃, immediately adding the minium, continuously stirring, uniformly mixing, spraying cold water to the medicinal ointment, solidifying the medicinal ointment, immersing the ointment in ethanol, and stirring, Adding glacial acetic acid and water (ethanol: glacial acetic acid: water =1:2.5: 4) into the solution for 24 hr, then placing the ointment into a container, melting with slow fire, adding the fine materials, stirring, and uniformly spreading the ointment on an ointment cloth. Is applied to affected parts and replaced every 48 hours.

The first example demonstrates that the black plaster in the example has the efficacies of promoting blood circulation by removing blood stasis, relieving swelling and pain, and the like. According to the treatment purpose of the traditional Chinese medicine external treatment method, a traditional Chinese medicine application method is used for treating swelling and pain so as to improve the local symptoms of a patient, relieve pain and improve the treatment effect. The black plaster is added with forsythia, crude drugs, ground beetle and other components, and is externally applied to the neck and chest of a patient to relieve swelling and pain, blood stasis, lumps, inflammation and the like, so that a good treatment effect is achieved.

The Chinese patent medicine consists of male essence, hackberry and borax in a weight ratio: naive: borax = 2: 5: 2.

clinical efficacy test:

126 volunteers, 40 with mammary gland hyperplasia, were divided into group A, and were randomly and evenly divided into experimental group and control group, and the comparison of general data between experimental group patients and control group patients had no statistical significance (P > 0.05), and had comparability; 26 persons with tonsillar enlargement are divided into a group B, and are randomly and averagely divided into an experimental group and a control group, and the comparison difference of the general data of the patients in the experimental group and the patients in the control group has no statistical significance (P is more than 0.05) and has comparability; the patients with lymphadenectasis 32 are divided into C groups, and are randomly and averagely divided into an experimental group and a control group, and the comparison difference of the general data of the patients in the experimental group and the patients in the control group has no statistical significance (P is more than 0.05), and has comparability; 28 persons with parotitis are divided into D groups, and the D groups are randomly and averagely divided into an experimental group and a control group, and the comparison difference of the general data of the patients in the experimental group and the patients in the control group has no statistical significance (P is more than 0.05), and the D groups are comparable.

2. The treatment method comprises the following steps: the preparation method of the external black plaster for the control group 1 comprises the following steps: 250g of minium is taken, crushed and sieved by a 120-mesh sieve for later use, 30g of toad venom is taken, crushed and sieved by a 120-mesh sieve to obtain fine materials for later use, 500g of castor oil is taken and heated to 35-50 ℃ under the environment of 18-26 ℃, 40g of centipede, 30g of radix bupleuri, 25g of radix salviae miltiorrhizae, 25g of radix scrophulariae, 25g of blackberry lily, 20g of radix curcumae, 20g of earthworm and 15g of scorpion are added into the fine materials, the castor oil is stirred, the castor oil is continuously heated to 210-240 ℃, the medicinal materials are fried to be dark brown on the surface and burnt yellow inside, the medicinal materials are filtered by a 120-mesh sieve, dregs are removed to obtain medicinal oil, the medicinal oil is reserved for later use, the medicinal oil is continuously decocted to be beaded at the temperature of 300-330 ℃, the medicinal oil is immediately added with minium and stirred without stopping heating, the stirring to obtain ointment, the ointment is sprayed with cold water to enable the ointment to be solidified, and the ointment is immersed in a solution consisting of ethanol, glacial acetic acid and water (ethanol, glacial acetic, then, placing the ointment into a container, melting with slow fire, adding the fine materials, stirring, and uniformly spreading the ointment on an ointment cloth.

The preparation method of the external black plaster for the experimental group 2 comprises the following steps: taking 250g of minium, crushing, sieving by a 120-mesh sieve for later use, taking 30g of toad venom and 20g of unprocessed medicinal materials, mixing, crushing, sieving by a 120-mesh sieve to obtain fine materials for later use, heating 500g of castor oil to 35-50 ℃ in an environment with the temperature of 18-26 ℃, adding 40g of centipede, 30g of radix bupleuri, 25g of radix salviae miltiorrhizae, 25g of radix scrophulariae, 25g of blackberry lily, 25g of ground beetle, 20g of radix curcumae, 20g of earthworm, 20g of fructus forsythiae and 15g of scorpion, stirring, continuously heating the castor oil to 210-240 ℃, frying the medicinal materials to the surface of which is dark brown and the interior of which is scorched, filtering by a 120-mesh sieve, removing dregs of the medicinal materials to obtain medicinal oil for later use, continuously decocting the medicinal oil to the degree of beading at the temperature of 300-330 ℃, immediately adding the minium, continuously stirring, uniformly mixing to obtain an ointment, spraying cold water to solidify the ointment, and putting the medicinal materials into ethanol for later use, Adding glacial acetic acid and water (ethanol: glacial acetic acid: water =1:2.5: 4) into the solution for 24 hr, then placing the ointment into a container, melting with slow fire, adding the fine materials, stirring, and uniformly spreading the ointment on an ointment cloth.

Black plaster 1 was applied to the affected parts of volunteers in the control group of A, B, C, D groups, and was replaced every 48 hours. The black plaster 2 was applied to the affected part of volunteers in A, B, C, D four groups of experimental groups, and was changed every 48 hours. The application was continued for 3 times. The therapeutic effect is shown in table 1.

TABLE 1 therapeutic results

The therapeutic effect judgment standard is as follows: and (3) healing: the pain disappears, the functional activity returns to normal, and the work and life are normal; improvement: the pain is obviously relieved, the functional activity is partially recovered, and the daily work and life can be carried out; and (4) invalidation: the pain is not obviously improved or aggravated, and the daily life is affected.

The cure rate = cure person/total person 100%

Good turnover rate = number of good turnover/total number of people 100%

Inefficiency = number of invalid persons/total persons 100%

Total effective number = number of healed persons + number of improvement persons

Total effective rate = total effective number/total number 100%

Remarking: the above "+" represents "multiplication number"

The results show that the cure rate and the total effective rate of all the four groups of A, B, C, D are greater than those of the control group, and the significant difference is achieved. The treatment effect of the black plaster 2 formula is better than that of the black plaster 1 formula, namely the black plaster formula of the embodiment has better treatment effect than that of the black plaster formula of the embodiment.

Third embodiment:

200-300 parts of minium is taken according to the weight part, crushed and sieved by a 120-mesh sieve for standby, 15-25 parts of frankincense, 25-35 parts of toad venom and 15-25 parts of crude drugs are mixed and crushed, and sieved by the 120-mesh sieve to obtain fine materials for standby, 400-600 parts of castor oil are taken and heated to 35-50 ℃ under the environment of the temperature of 18-26 ℃, 30-50 parts of centipede, 25-35 parts of radix bupleuri, 20-30 parts of salvia miltiorrhiza, 20-30 parts of radix scrophulariae, 20-30 parts of blackberry lily, 15-25 parts of radix curcumae, 20-30 parts of ground beetle, 15-25 parts of earthworm, 15-25 parts of fructus forsythiae and 10-20 parts of scorpion are added and stirred, the medicinal materials are fried to be withered on the surface, 15-25 parts of honeysuckle are added and stirred, the castor oil is continuously heated to 210-240 ℃, the medicinal materials are fried to be dark brown and burnt yellow on the inside, filtered by the 120-mesh sieve, the dregs are removed, the medicinal oil is obtained for standby at the temperature of 300-330 ℃, decocting the medicinal oil to a degree of dripping into bead, stopping heating, immediately adding Plumbum Preparatium, stirring, mixing to obtain unguent, spraying cold water to solidify the unguent, soaking the unguent in solution of ethanol, glacial acetic acid, and water (ethanol: glacial acetic acid: water =1:2.5: 4) for 24 hr, placing the unguent in a container, melting with slow fire, adding fine materials, stirring, and uniformly spreading the unguent on the cloth.

Selecting 250 parts of minium according to parts by weight, crushing, sieving by a 120-mesh sieve for later use, mixing and crushing 20 parts of frankincense, 30 parts of toad venom and 20 parts of unprepared drugs, sieving by a 120-mesh sieve to obtain fine materials, heating 500 parts of castor oil to 35-50 ℃ in an environment with the temperature of 18-26 ℃, adding 40 parts of centipede, 30 parts of radix bupleuri, 25 parts of salvia miltiorrhiza, 25 parts of radix scrophulariae, 25 parts of blackberry lily, 20 parts of radix curcumae, 25 parts of ground beetle, 20 parts of earthworm, 20 parts of fructus forsythiae and 15 parts of scorpion, stirring, frying the medicinal materials to be withered yellow on the surface, adding 20 parts of honeysuckle, stirring, continuously heating the castor oil to 210-240 ℃, frying the medicinal materials to be dark brown on the surface and scorched yellow inside, filtering by the 120-mesh sieve, removing dregs of the medicinal materials to obtain medicinal oil for later use, continuously decocting the medicinal oil to be beaded at the temperature of 300-330 ℃, stopping fire, immediately adding the minium, and continuously stirring, mixing to obtain ointment, spraying cold water to solidify the ointment, soaking the ointment in a solution of ethanol, glacial acetic acid, and water (ethanol: glacial acetic acid: water =1:2.5: 4) for 24 hr, placing the ointment in a container, melting with slow fire, adding fine materials, stirring, and spreading the ointment on a cloth. Is applied to affected parts and replaced every 48 hours.

After the skin is damaged, symptoms such as inflammation, red swelling, swelling pain and the like are more likely to appear, but the black plaster in the above embodiment has certain irritation when being applied to the damaged skin, and the application range of the black plaster is limited. In the embodiment, in order to reduce the irritation of the components of the black plaster to the damaged skin, a large number of screening tests are carried out according to the principles of traditional Chinese medicine dialectical treatment and the efficacy, main treatment and meridian tropism of traditional Chinese medicines, the efficacy of the medicines in coordination is fully adjusted, and the honeysuckle and the frankincense are selected and added into the formula, so that the effect of reducing the irritation of the black plaster is achieved.

The honeysuckle flower is also called honeysuckle flower, and is a dried flower bud or a flower with initial blossoming of Lonicera japonica Thunb, Lonicera hypoglauca Miq, Lonicera confusa DC or Lonicera dasycarpus Rehd of Lonicera japonica Thunb. The double flowers are known as "fire-reducing hero", also known as "plant antibiotics", and are good at removing toxicity, removing toxicity and pus, and are holy drugs after ulcer of superficial infection.

Boswellia carterii Birdw, Boswellia Birdw, and Boswellia latifolia B, Neglecta M, Moore, etc., belonging to Boswellia of Burseraceae, are administered with oleoresin exuded from the wound of the bark of the trunk.

Animal skin irritation test:

taking 8 healthy adult rabbits and 8 newly weaned young rabbits respectively, and taking the male rabbit and the female rabbit respectively in half. Two damaged skin areas are respectively arranged on the left side and the right side of the back of each rabbit by adopting a self-contrast method. The skin preparation is carried out 24 hours in advance. The left side is pasted with black plaster 2, the right side is pasted with black plaster 3, the area is 3cm multiplied by 3cm, the application time is 48h, the medicine is cleaned and removed after the application is finished, and the medicine is continuously administered for 10 d. Erythema and edema were recorded daily at 1h before and after dosing, and continued at 1h, 24h, 48h and 72h after the last dose. If moderate or above stimulation is present, recovery observation is continued for 14d and the recovery period is terminated and histopathological examination of the administration site is performed. And (4) scoring according to skin irritation response scoring standards, calculating average scores, and evaluating irritation strength. No erythema, edema count 0 points, mild erythema, edema (barely visible) count 1 point each, moderate edema, erythema (clearly visible) count 2 points each, severe edema (skin bulge 1mm, clear outline), erythema count 3 points each, purplish red erythema to mild eschar formation, severe edema (skin bulge more than 1mm with enlargement) count 4 points each; after the average value of all the scores is taken, 0-0.49 is non-irritant, 0.5-2.99 is mild irritant, 3-5.99 is moderate irritant, and 6-8 is severe irritant.

The preparation method of the rabbit damaged skin comprises the following steps: the skin of the tested part at the two sides of the back of the rabbit is scratched with a sterilized large-gauge needle in a shape like a Chinese character '#', the scratched cuticle and slight bleeding can be obviously seen by naked eyes, and the distance between the marks is about 0.5 cm.

The preparation method of the black plaster 2 comprises the following steps: taking 250g of minium, crushing, sieving by a 120-mesh sieve for later use, taking 30g of toad venom and 20g of unprocessed medicinal materials, mixing, crushing, sieving by a 120-mesh sieve to obtain fine materials for later use, heating 500g of castor oil to 35-50 ℃ in an environment with the temperature of 18-26 ℃, adding 40g of centipede, 30g of radix bupleuri, 25g of radix salviae miltiorrhizae, 25g of radix scrophulariae, 25g of blackberry lily, 25g of ground beetle, 20g of radix curcumae, 20g of earthworm, 20g of fructus forsythiae and 15g of scorpion, stirring, continuously heating the castor oil to 210-240 ℃, frying the medicinal materials to the surface of which is dark brown and the interior of which is scorched, filtering by a 120-mesh sieve, removing dregs of the medicinal materials to obtain medicinal oil for later use, continuously decocting the medicinal oil to the degree of beading at the temperature of 300-330 ℃, immediately adding the minium, continuously stirring, uniformly mixing to obtain an ointment, spraying cold water to solidify the ointment, and putting the medicinal materials into ethanol for later use, Adding glacial acetic acid and water (ethanol: glacial acetic acid: water =1:2.5: 4) into the solution for 24 hr, then placing the ointment into a container, melting with slow fire, adding the fine materials, stirring, and uniformly spreading the ointment on an ointment cloth.

The preparation method of the black plaster 3 comprises the following steps: taking 250g of minium, crushing, sieving with a 120-mesh sieve for later use, heating 500g of castor oil to 35-50 ℃ for later use, adding 40g of centipede, 30g of radix bupleuri, 25g of radix salviae miltiorrhizae, 25g of radix scrophulariae, 25g of blackberry lily, 20g of radix curcumae, 25g of ground beetle, 20g of earthworm, 20g of fructus forsythiae and 15g of scorpion, stirring, frying the medicinal materials to be withered yellow on the surface, adding 20g of honeysuckle, stirring, continuously heating the castor oil to 210-240 ℃, frying the medicinal materials to be dark brown on the surface and scorched yellow inside, filtering with the 120-mesh sieve, removing dregs of a medicine to obtain medicinal oil for later use, continuously decocting the medicinal oil to be beaded at 300-330 ℃, stopping heating, adding the minium, immediately stirring, dripping water and uniformly mixing, spraying cold water to solidify the ointment, soaking the ointment in a solution of ethanol, glacial acetic acid and water (ethanol: glacial acetic acid: water =1:2.5: 4) for 24 hr, placing the ointment in a container, melting with slow fire, adding the fine materials, stirring, and spreading the ointment on a cloth.

And (3) test results: observations showed that after 3 days of administration, 16 rabbits applied on the left side with the black plaster 2 showed mild erythema and edema on all the administered sites, and that adult and young rabbits showed mild to moderate irritation after 10 days of administration. The young rabbits and the adult rabbits are approximately recovered to the state before the administration on the 6 th day and the 10 th day after the withdrawal of the medicine respectively; observation showed that the right side was coated with the black plaster on one side of 3d, and the administered part of all rabbits had no erythema and edema after 3d administration, and after 7 days, 3 young rabbits had slight erythema but no edema, and 1 young rabbit had slight erythema and slight edema, and after 10d administration, the slight erythema and edema resolved after 24 h.

Histopathological examination shows that the skin epidermal cells on one side of the right side of the rabbit, which is pasted with the black plaster 3, are increased, the epidermis is thickened, and the skin thickening degree of young rabbits is lower; compared with the side of the adult rabbit which is pasted with the black plaster 2, the side which is pasted with the black plaster 3 on the right side of the adult rabbit has more obvious degrees of subcutaneous inflammatory cell infiltration, edema or tissue repair. The young animals recover better and more quickly than the adult animals.

The results show that: the irritation of the black plaster 3 to the damaged skin is obviously less than that of the black plaster 2, and the black plaster 3 also has no irritation to the skin of young rabbits, and can be safely applied.

The fourth embodiment:

200-300 parts of minium is taken according to the weight part, crushed and sieved by a 120-mesh sieve for standby, 15-25 parts of frankincense, 25-35 parts of toad venom and 15-25 parts of crude drug are mixed and crushed, and sieved by the 120-mesh sieve to obtain fine material for standby, 400-600 parts of castor oil is taken and heated to 35-50 ℃ under the environment of 18-26 ℃, 25-35 parts of radix bupleuri, 20-30 parts of salvia miltiorrhiza, 20-30 parts of radix scrophulariae, 20-30 parts of blackberry lily, 15-25 parts of radix curcumae, 30-50 parts of centipede, 20-30 parts of ground beetle, 15-25 parts of earthworm, 15-25 parts of fructus forsythiae, 10-20 parts of scorpion and 15-25 parts of laurel are added, the mixture is stirred, the drug is fried to be dry yellow on the surface, 15-25 parts of honeysuckle and 15-25 parts of fennel are added, the mixture is stirred, the castor oil is continuously heated to 210-240 ℃, the drug is fried to be dark brown on the surface and burnt yellow inside, the drug is filtered by the 120-mesh sieve to remove dregs, and (2) obtaining medicinal oil for later use, continuously decocting the medicinal oil at the temperature of 300-330 ℃ to a degree of dripping water into beads, stopping heating, immediately adding Plumbum Preparatium, continuously stirring, uniformly mixing to obtain an ointment, spraying cold water on the ointment to solidify the ointment, immersing the ointment in a solution consisting of ethanol, glacial acetic acid and water (ethanol: glacial acetic acid: water =1:2.5: 4) for 24 hours, then placing the ointment in a container, melting with slow fire, adding fine materials, uniformly stirring, and uniformly spreading the ointment on an ointment cloth.

Selecting 250 parts of minium according to parts by weight, crushing, sieving by a 120-mesh sieve for later use, mixing and crushing 20 parts of frankincense, 30 parts of toad venom and 20 parts of undried drug, sieving by a 120-mesh sieve to obtain fine powder, heating 500 parts of castor oil to 35-50 ℃ in an environment with the temperature of 18-26 ℃, adding 30 parts of radix bupleuri, 25 parts of salvia miltiorrhiza, 25 parts of radix scrophulariae, 25 parts of blackberry lily, 20 parts of radix curcumae, 40 parts of centipede, 25 parts of ground beetle, 20 parts of earthworm, 20 parts of fructus forsythiae, 15 parts of scorpion and 20 parts of laurel, stirring, frying the medicinal materials until the surfaces of the medicinal materials are withered yellow, adding 20 parts of honeysuckle and 20 parts of fennel, stirring, continuously heating the castor oil to 210-240 ℃, frying the medicinal materials until the surfaces of the medicinal materials are dark brown and the interiors of the medicinal materials are scorched, filtering by a 120-mesh sieve, removing drug residues to obtain medicinal oil, decocting for later use, continuously preparing the medicinal oil into water drops at the temperature of 300-330 ℃, stopping fire, adding Plumbum Preparatium immediately, stirring, mixing to obtain unguent, spraying cold water to solidify unguent, soaking unguent in solution composed of ethanol, glacial acetic acid, and water (ethanol: glacial acetic acid: water =1:2.5: 4) for 24 hr, placing the unguent in a container, melting with slow fire, adding fine materials, stirring, and uniformly spreading the unguent on plaster cloth. Is applied to affected parts and replaced every 48 hours.

The low transdermal absorption rate is an important factor for restricting the black plaster to exert the drug effect, expand the application range and popularize and apply. In the embodiment, the transdermal absorption of the medicament is promoted by adding the medicinal components of the black plaster, so that a good effect is achieved.

Laurel is fruit of Laurel of Lauraceae. The fruit contains 1% of aromatic oil. The dried fruit contains fat 44.1%, Lauric acid 1%, palmitic acid 19%, oleic acid 56.6%, linoleic acid 21%, and linolenic acid 2.5%. The nut contains 26.3% of fat, 45.1% of lauric acid, 3.8% of palmitic acid, 28% of oleic acid and 23.1% of linoleic acid.

Fructus Foeniculi is dried mature fruit of Foeniculum vuLgare vuLgare Mill. The fruit contains volatile oil about 3-8%, and its main components are anisole 50-60%, d-cuminone 18-20%, d-and l-limonene, pinene, dipentene, anisaldehyde, etc. The endosperm contains about 15% of fatty oil and about 20% of protein. In addition, it contains vitamin A-like substances, starch, saccharides, and mucilage. The leaf contains xanthophyll glycoside, anisidine (quercetin-3-L-arabinoside), kaempferol-3-arabinoside, kaempferol-3-glucuronic acid and quercetin-3-glucuronic acid.

Transdermal absorption test:

preparation of in vitro skin: a test-grade male SD rat of about 200g is taken, hairs on the back of the rat are carefully cut off by a shaver after anesthesia, the rat is killed after being washed clean, the skin on the back is cut off, fat and subcutaneous tissues are removed, the skin in a selected area is complete, the rat is repeatedly washed clean by normal saline and stored in a refrigerator at the temperature of minus 20 ℃ for later use. The test was started by thawing naturally and checking the integrity of the skin each time without any damage.

Preparing black ointment:

the preparation method of the black plaster 1 comprises the following steps: 250g of minium is taken, crushed and sieved by a 120-mesh sieve for later use, 30g of toad venom is taken, crushed and sieved by a 120-mesh sieve to obtain fine materials for later use, 500g of castor oil is taken and heated to 35-50 ℃ under the environment of 18-26 ℃, 40g of centipede, 30g of radix bupleuri, 25g of radix salviae miltiorrhizae, 25g of radix scrophulariae, 25g of blackberry lily, 20g of radix curcumae, 20g of earthworm and 15g of scorpion are added into the fine materials, the castor oil is stirred, the castor oil is continuously heated to 210-240 ℃, the medicinal materials are fried to be dark brown on the surface and burnt yellow inside, the medicinal materials are filtered by a 120-mesh sieve, dregs are removed to obtain medicinal oil, the medicinal oil is reserved for later use, the medicinal oil is continuously decocted to be beaded at the temperature of 300-330 ℃, the medicinal oil is immediately added with minium and stirred without stopping heating, the stirring to obtain ointment, the ointment is sprayed with cold water to enable the ointment to be solidified, and the ointment is immersed in a solution consisting of ethanol, glacial acetic acid and water (ethanol, glacial acetic, then, placing the ointment into a container, melting with slow fire, adding the fine materials, stirring, and uniformly spreading the ointment on an ointment cloth.

The preparation method of the black plaster 4 comprises the following steps: selecting 250g of minium according to parts by weight, crushing, sieving by a 120-mesh sieve for later use, mixing and crushing 20g of frankincense, 30g of toad venom and 20g of undried drug for later use, heating 500g of castor oil to 35-50 ℃ in an environment with the temperature of 18-26 ℃, adding 30g of radix bupleuri, 25g of salvia miltiorrhiza, 25g of radix scrophulariae, 25g of blackberry lily, 20g of radix curcumae, 40g of centipede, 25g of ground beetle, 20g of earthworm, 20g of fructus forsythiae, 15g of scorpion and 20g of laurel, stirring, frying the medicinal materials until the surfaces of the medicinal materials are withered yellow, adding 20 parts of honeysuckle and 20 parts of fennel, stirring, continuously heating the castor oil to 210-240 ℃, frying the medicinal materials until the surfaces of the medicinal materials are dark brown and the interiors of the medicinal materials are scorched yellow, filtering by the 120-mesh sieve, removing dregs of the medicinal materials to obtain medicinal oil for later use, continuously preparing the medicinal oil into dripping water into drops at the temperature of 300-330 ℃, stopping fire, adding Plumbum Preparatium immediately, stirring, mixing to obtain unguent, spraying cold water to solidify unguent, soaking unguent in solution composed of ethanol, glacial acetic acid, and water (ethanol: glacial acetic acid: water =1:2.5: 4) for 24 hr, placing the unguent in container, melting with slow fire, adding fine materials, stirring, and uniformly spreading unguent on cloth.

The test method comprises the following steps: cutting prepared rat skin into 4 pieces with appropriate size, placing between 4 supply pools and receiving pools of transdermal tester, respectively, the receiving pool volume is 17ml, and the diffusion surfaceProduct 1.67cm². Respectively sticking the black plaster 1, the black plaster 2, the black plaster 3 and the black plaster 4 on the outer surface of the standby rat skin, and fixing the rat skin stuck with the plaster between a diffusion chamber and a receiving chamber of a diffusion instrument with the sticking surface facing upwards. The receiving pool was filled with 30% ethanol physiological saline. The water bath is kept at the constant temperature of 37 ℃, the stirrer is stirred at a constant speed of 200 r/min, 5ml of receiving solution is taken out of the sample receiving pool respectively 2h, 4h, 6h, 8h, 10h and 12h after the start of the experiment, and simultaneously 30% ethanol physiological saline preheated at 37 ℃ with the same volume is added. Filtering the obtained liquid with 0.45 μm microporous membrane, removing bubbles by ultrasonic wave, and measuring effective component tanshinone II contained in black plaster 1, black plaster 2, black plaster 3, and black plaster 4 by high performance liquid chromatography_AAnd the cumulative permeation amount of saikosaponin a. The results are shown in Table 2.

TABLE 2 tanshinone II_AAnd the determination result of saikosaponin a

From the measurement results, it was found that: tanshinone II in black plaster 1, black plaster 2 and black plaster 3_AThe accumulated permeability of the saikosaponin a has no obvious difference; tanshinone II in black plaster 4_AThe cumulative permeation amount of the saikosaponin a is obviously higher than that of the black plaster 1, the black plaster 2 and the black plaster 3. The specific components of the laurel and the fennel in the black plaster 4 formula have the effect of promoting the skin transdermal absorption, the effect difference of the skin transdermal absorption promotion in the first 4 hours is small, and the difference is gradually obvious after 4 hours. The laurel and the fennel added in the black plaster can obviously improve the transdermal efficiency of the main active ingredients.

Claims

1. A black plaster for softening hardness to dissipate stagnation, relieving swelling and pain is characterized in that:

the black plaster comprises the following raw material medicines in parts by weight: 30-50 parts of centipede, 25-35 parts of toad venom, 25-35 parts of radix bupleuri, 20-30 parts of salvia miltiorrhiza, 20-30 parts of radix scrophulariae, 20-30 parts of blackberry lily, 15-25 parts of radix curcumae, 15-25 parts of earthworm, 10-20 parts of scorpion, 200-300 parts of minium and 400-600 parts of castor oil.

2. A black plaster for softening hardness to dissipate stagnation, relieving swelling and pain according to claim 1, which is characterized in that:

the black plaster comprises the following raw material medicines in parts by weight: 40 parts of centipede, 30 parts of toad venom, 30 parts of radix bupleuri, 25 parts of salvia miltiorrhiza, 25 parts of radix scrophulariae, 25 parts of blackberry lily, 20 parts of radix curcumae, 20 parts of earthworm, 15 parts of scorpion, 250 parts of minium and 500 parts of castor oil.

3. A process for preparing a black plaster for softening hardness to dissipate stagnation, relieving swelling and alleviating pain as claimed in claim 1 or 2, wherein:

pulverizing Plumbum preparatium, and sieving with 120 mesh sieve;

heating castor oil to 35-50 deg.C at 18-26 deg.C, adding Scolopendra, bupleuri radix, Saviae Miltiorrhizae radix, radix scrophulariae, rhizoma Belamcandae, radix Curcumae, Lumbricus, and Scorpio, stirring, heating castor oil to 210-240 deg.C, frying until the surface is dark brown and the interior is dark yellow, filtering with 120 mesh sieve, and removing residue to obtain medicinal oil;

continuously decocting the medicinal oil at 300-330 deg.C to a degree of dripping water into beads, stopping heating, immediately adding Plumbum Preparatium, stirring, and mixing to obtain unguent;

spraying cold water to solidify the ointment, soaking the ointment in a solution of ethanol, glacial acetic acid, and water for 24 hr, placing the ointment in a container, melting with slow fire, adding fine materials, stirring, and uniformly spreading the ointment on a cloth.

4. A black plaster for softening hardness to dissipate stagnation, relieving swelling and pain is characterized in that:

the black plaster comprises the following raw material medicines in parts by weight: 30-50 parts of centipede, 25-35 parts of toad venom, 25-35 parts of radix bupleuri, 20-30 parts of radix salviae miltiorrhizae, 20-30 parts of radix scrophulariae, 20-30 parts of blackberry lily, 15-25 parts of radix curcumae, 15-25 parts of earthworm, 10-20 parts of scorpion, 200-300 parts of minium, 400-600 parts of castor oil, 15-25 parts of fructus forsythiae, 15-25 parts of crude drugs and 20-30 parts of ground beetle.

5. The preparation process of the black plaster for resolving hard lump, relieving swelling and pain as claimed in claim 4, wherein the black plaster comprises the following steps:

pulverizing Plumbum preparatium, and sieving with 120 mesh sieve;

6. A black plaster for softening hardness to dissipate stagnation, relieving swelling and pain is characterized in that:

the black plaster comprises the following raw material medicines in parts by weight: 30-50 parts of centipede, 25-35 parts of toad venom, 25-35 parts of radix bupleuri, 20-30 parts of radix salviae miltiorrhizae, 20-30 parts of radix scrophulariae, 20-30 parts of blackberry lily, 15-25 parts of radix curcumae, 15-25 parts of earthworm, 10-20 parts of scorpion, 200-300 parts of minium, 400-600 parts of castor oil, 15-25 parts of fructus forsythiae, 15-25 parts of crude drug and 20-30 parts of ground beetle, 15-25 parts of frankincense and 15-25 parts of honeysuckle are added.

7. The preparation process of the black plaster for resolving hard lump, relieving swelling and pain as claimed in claim 6, wherein the black plaster comprises the following steps:

pulverizing Plumbum preparatium, and sieving with 120 mesh sieve;

8. A black plaster for softening hardness to dissipate stagnation, relieving swelling and pain is characterized in that:

the black plaster comprises the following raw material medicines in parts by weight: 30-50 parts of centipede, 25-35 parts of toad venom, 25-35 parts of radix bupleuri, 20-30 parts of radix salviae miltiorrhizae, 20-30 parts of radix scrophulariae, 20-30 parts of blackberry lily, 15-25 parts of radix curcumae, 15-25 parts of earthworm, 15-25 parts of frankincense, 10-20 parts of scorpion, 200-300 parts of minium, 400-600 parts of castor oil, 15-25 parts of fructus forsythiae, 15-25 parts of crude drug, 20-30 parts of ground beetle and 15-25 parts of honeysuckle are added, and 15-25 parts of laurel seed and 15-25 parts of fennel are added.

9. The preparation process of the black plaster for resolving hard lump, relieving swelling and pain as claimed in claim 8, wherein the black plaster comprises the following steps:

pulverizing Plumbum preparatium, and sieving with 120 mesh sieve;

10. A process for preparing a black plaster for softening and resolving hard mass, decreasing swelling and alleviating pain as claimed in claim 3, 5, 7 or 9, wherein:

the volume ratio of the solution consisting of ethanol, glacial acetic acid and water is that the ratio of ethanol to glacial acetic acid to water is =1:2.5: 4.