CN113679695A - Radix aconiti extract gel emplastrum and preparation method thereof - Google Patents

Radix aconiti extract gel emplastrum and preparation method thereof Download PDF

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CN113679695A
CN113679695A CN202111180327.8A CN202111180327A CN113679695A CN 113679695 A CN113679695 A CN 113679695A CN 202111180327 A CN202111180327 A CN 202111180327A CN 113679695 A CN113679695 A CN 113679695A
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radix aconiti
gel
extract
emplastrum
preparation
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刘越飞
张定堃
耿福能
裴瑾
刘彬
贺亚男
马秀英
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Sichuan Jianengda Panxi Pharmaceutical Industry Co ltd
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Sichuan Jianengda Panxi Pharmaceutical Industry Co ltd
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    • A61K36/71Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
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    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
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    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/70Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • A61K9/703Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
    • A61K9/7038Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
    • A61K9/7046Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
    • A61K9/7053Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene
    • A61K9/7061Polyacrylates
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/02Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

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Abstract

The invention discloses a radix aconiti extract gel paste and a preparation method thereof. The gel paste comprises the following components: extracts of different parts of common monkshood mother root, acrylic resin, a cross-linking agent, a humectant, a filler, an adhesive, a transdermal enhancer, a metal ion chelating agent, a pH regulator and pure water; the radix Aconiti different parts or radix Aconiti Preparata extract comprises one or more of radix Aconiti, radix Aconiti Preparata, radix Aconiti stem and leaf, radix Aconiti lateralis Preparata and radix Aconiti lateralis Preparata extract; the invention also provides a preparation method of the gel emplastrum, and pharmacological experimental research shows that the gel emplastrum has better anti-inflammatory and analgesic effects and can be used as a supplementary treatment method for treating rheumatoid arthritis, rheumatic arthritis and arthralgia.

Description

Radix aconiti extract gel emplastrum and preparation method thereof
Technical Field
The invention belongs to the field of medicines, and particularly relates to radix aconiti extract gel emplastrum and a preparation method thereof.
Background
Aconitum carmichaeli Debx (Aconitum carmichaeli Debx.) is a plant belonging to Ranunculaceae, has effects of dispelling pathogenic wind, removing dampness, warming channels and relieving pain, and has effects of restoring yang, relieving adverse qi, invigorating fire, tonifying yang, dispelling cold and relieving pain. The common part of aconitum chinese wolf is its root, while the overground part is generally discarded directly, but modern researches show that different parts of aconitum chinese wolf contain the same chemical components and different contents.
The gel paste is prepared by mixing medicinal material extract, decoction pieces or chemical medicine with appropriate hydrophilic matrix, and coating on backing material. Has the advantages of large drug loading, accurate dosage, repeated application, comfort, small irritation and allergy, air permeability, moisture retention, good permeability, etc.
Rheumatoid Arthritis (RA) is a highly heterogeneous, chronic, systemic autoimmune disease that occurs well in middle aged people, especially women. In recent years, the traditional Chinese medicine has obvious curative effects on treating rheumatoid arthritis and rheumatic joints. According to the traditional Chinese medicine, the rheumatoid arthritis and the rheumatic arthritis are caused by the fact that wind, cold and dampness invade a human body and accumulate heat for a long time, or the body is hot and heat is stagnated in meridians, so that the meridians are not smooth, and the liver and kidney are damaged and muscles and bones of the whole body are not nourished for a long time, so that the joint is stiff, malformed and painful. The first important point in the treatment method is to dispel wind-damp and alleviate pain. At present, the exact etiology and pathogenesis of rheumatoid arthritis and rheumatic arthritis are not clear at present, no specific medicine is clinically used, most doctors often select non-steroidal anti-inflammatory drugs, chronic anti-rheumatic drugs, glucocorticoids and biological agents for combined use, the medicines are poor in treatment effect, and the risk of adverse reaction is increased after long-term administration, so that the treatment is difficult. Aconitum carmichaeli has been used for thousands of years in China, and is widely used for treating rheumatoid arthritis, rheumatic arthritis and various joint swelling and pain, but most aconitum carmichaeli medicines are extremely toxic, are careless, are easy to cause poisoning and even die, have narrow oral safety window range and high administration risk, and can reduce the potential risk by adopting transdermal administration such as gel emplastrum.
The invention provides a gel composition containing different parts of monkshood, which has good crosslinking performance, so that a gel ointment taking the gel composition as an ointment does not have the phenomenon of ointment leakage when being applied, is convenient to use, has good uncovering property, does not remain on skin, is prepared into the gel ointment, can be used for resisting inflammation and easing pain, and can be used as a supplementary treatment method for treating rheumatoid arthritis, rheumatic arthritis and arthralgia.
Disclosure of Invention
The invention aims to provide a gel emplastrum of different part extracts of monkshood and a preparation method thereof, and the prepared gel emplastrum can be used for resisting inflammation and easing pain and can be used as a supplementary treatment method for treating rheumatoid arthritis, rheumatic arthritis and arthralgia.
The invention provides a radix aconiti extract gel emplastrum which comprises the following components in percentage by weight:
20-70% of radix aconiti extract, 1-3% of acrylic resin, 0.02-0.09% of cross-linking agent, 10-30% of humectant, 1-8% of filler, 1.5-4.5% of adhesive, 1.5-3.0% of transdermal enhancer, 0.05-0.3% of metal ion chelating agent, 0.1-0.5% of pH regulator and the balance of pure water.
Further, the gel emplastrum comprises the following components in percentage by weight:
40-60% of radix aconiti extract, 1.5-3% of acrylic resin, 0.036-0.073% of cross-linking agent, 15-30% of humectant, 2-6% of filler, 2-4.25% of adhesive, 1.7-2.8% of transdermal enhancer, 0.08-0.12% of metal ion chelating agent, 0.1-0.5% of pH regulator and the balance of pure water.
Further, the gel emplastrum comprises the following components in percentage by weight:
60% of radix aconiti extract, 2% of acrylic resin, 0.06% of cross-linking agent, 30% of humectant, 6% of filler, 2.75% of adhesive, 2.2% of transdermal enhancer, 0.1% of metal ion chelating agent, 0.15% of pH regulator and the balance of pure water.
Further, the acrylic resin is one or more of methyl ester, ethyl ester, dimethylamino ethyl ester, or copolymer sodium polyacrylate NP600, NP700 and NP 800;
the cross-linking agent is high-valence metal salt, mainly is aluminum salt, such as one or more of dihydroxyaluminum glycinate, crystalline aluminum chloride, aluminum sulfate, aluminum glycinate, alum or composite aluminum salt;
the humectant is one or more of glycerol, propylene glycol, sorbitol and polyethylene glycol;
the filler is selected from one or more of silicon dioxide, kaolin, diatomite, talcum powder, graphite, carbon black, alumina powder, glass powder, asbestos powder, mica powder, quartz powder, carbon fiber and powdered cork;
the adhesive is one or more of methylcellulose, carboxymethylcellulose and sodium salt CMC-Na thereof, sodium polyacrylate, polyvinyl alcohol PVA, polyvinylpyrrolidone PVP, carbomer and xanthan gum;
the transdermal absorption enhancer is one or more of dimethyl sulfoxide, Azone, oleum Menthae Dementholatum, Borneolum Syntheticum, oleum Eucalypti, and propylene glycol;
the metal ion chelating agent is ethylenediamine disodium oxalate EDTA-Na2
Further, the acrylic resin is one or more of sodium polyacrylate NP600, NP700 and NP 800;
the cross-linking agent is aluminum glycollate and crystalline aluminum chloride;
the humectant is glycerin;
the filler is one or more of silicon dioxide, diatomite and talcum powder;
the adhesive is CMC-Na and carbomer;
the transdermal absorption enhancer is one or more of azone and eucalyptus oil;
the metal ion chelating agent is ethylenediamine disodium oxalate EDTA-Na2
Further, the radix aconiti extract contains extracts of different parts or different processed products, and consists of one or more of extracts of raw radix aconiti, prepared radix aconiti, radix aconiti stem and leaf, raw radix aconiti lateralis preparata, black shun slice, white radix aconiti lateralis, light radix aconiti lateralis and processed radix aconiti lateralis, and the preparation method comprises the following steps: the raw radix aconiti, the raw radix aconiti lateralis preparata, the stem and leaf of the radix aconiti and the monkshood are extracted by adding water and decocted for 4 hours, the black shun slices, the raw radix aconiti lateralis preparata, the processed radix aconiti lateralis preparata and the processed radix aconiti are decocted by adding water and decocted for 2 hours, all extracting solutions are concentrated by opening the mouth, and the extracting solution is concentrated into a medicine extract with the relative density of 1.10-1.20 at the temperature of 60 ℃.
The invention also provides a preparation method of the radix aconiti extract gel emplastrum, which comprises the following steps:
a. preparing an oil phase: accurately weighing the acrylic resin, the adhesive, the cross-linking agent, the metal ion chelating agent and the humectant according to the formula ratio, placing the above substances in an open container, stirring and dispersing uniformly, and placing for later use;
b. preparing an aqueous phase: accurately weighing the extracts of different parts of the monkshood, the filler and the pH regulator according to the formula ratio, adding water and uniformly stirring;
c. preparing gel paste: slowly adding the water phase into the oil phase, rapidly stirring to form a viscous colloid with certain cohesion, uniformly coating the colloid on non-woven fabric, drying at 40 deg.C for 3 hr, taking out, recovering to normal temperature, cutting into rectangular bodies, and covering with a liner.
Further, the rectangular parallelepiped obtained in step c has a thickness of 0.5 to 1.0cm, and is one of 7 × 10cm, 8 × 12cm, 10 × 10cm, and 10 × 14 cm.
The radix aconiti extract gel emplastrum is applied to the preparation of anti-inflammatory and analgesic drugs.
The radix aconiti extract gel emplastrum is applied to rheumatoid arthritis, rheumatic arthritis and arthralgia.
Advantageous effects
The invention aims to provide a gel emplastrum of different part extracts of common monkshood mother root and a preparation method thereof, the gel emplastrum takes extracts of different parts of common monkshood mother root as main effective components, compared with the prior art, the common monkshood mother root gel emplastrum is prepared by adopting the common monkshood mother root Chinese medicament and auxiliary materials, pharmacological experiment results show that the gel emplastrum has better anti-inflammatory and analgesic effects, compared with the traditional Chinese medicament compound gel emplastrum in the prior art, the effect is better, the raw material of the gel emplastrum is only one of radix aconiti, while the prior art is mostly a traditional Chinese medicine compound, the preparation process is complicated, the quality of the raw material medicine is difficult to control, the preparation process is simple, the quality of the raw material medicine can be effectively ensured, the time and the cost are saved, the action and the curative effect are also improved, can be used as a supplementary therapy for treating rheumatoid arthritis, rheumatic arthritis and arthralgia. In addition, the gel composition has good crosslinking performance, so that the gel paste taking the gel composition as paste does not have paste leakage phenomenon when being applied, is convenient to use, has good stripping performance and does not remain on skin.
Detailed description of the preferred embodiments
The present invention will now be described in further detail with reference to specific examples, but it should not be construed that the scope of the invention as claimed is limited to the examples described below, and it will be understood by those skilled in the art that changes and substitutions in the details and forms of the technical solution of the present invention may be made without departing from the scope of the invention, but they are within the scope of the invention.
Example 1
Figure BDA0003296816890000041
The preparation method comprises the following steps:
a. preparing an oil phase: accurately weighing NP700, CMC-Na, carbomer, aluminum chloride and EDTA-Na according to the formula ratio2Putting the materials into an open container, stirring and dispersing uniformly, and then placing for later use;
b. preparing an aqueous phase: accurately weighing the prepared radix aconiti extract, the diatomite, the tartaric acid, the water and the like according to the formula ratio, and uniformly stirring;
c. preparing gel paste: the aqueous phase is slowly added to the oil phase and rapidly stirred until a viscous gel with a certain cohesion is formed. Uniformly coating the colloid on non-woven fabric, drying at 40 deg.C for 3 hr, taking out, recovering to normal temperature, cutting into 10 × 10cm cubes, and covering with a liner.
The obtained gel paste was subjected to sensory evaluation (consistency, spreading property, uniformity, skin-following property, repeated release property) and initial adhesion test by a rolling ball method (0925 in the 4 th official gazette of the Chinese pharmacopoeia), and the larger the number of the adhered small ball, the larger the initial adhesion. The results show that: the paste is formed, has proper consistency, spreading property, uniformity, skin following property and repeated stripping property, has initial adhesion of No. 16 small balls, and meets the requirement.
Example 2
Figure BDA0003296816890000051
A gel paste was prepared according to the preparation method of example 1. The obtained gel paste was subjected to sensory evaluation (consistency, spreadability, uniformity, skin-following property, repeated detachability) and initial adhesion test, and the results showed that: the paste is formed, has proper consistency, spreading property, uniformity, skin following property and repeated stripping property, has initial adhesion of No. 15 small balls, and meets the requirement.
Example 3
Figure BDA0003296816890000052
A gel paste was prepared according to the preparation method of example 1. The obtained gel paste was subjected to sensory evaluation (consistency, spreadability, uniformity, skin-following property, repeated detachability) and initial adhesion test, and the results showed that: the paste is formed, has proper consistency, spreading property, uniformity, skin following property and repeated stripping property, has initial adhesion of No. 11 small balls, and meets the requirement.
Example 4
Figure BDA0003296816890000053
A gel paste was prepared according to the preparation method of example 1. The obtained gel paste was subjected to sensory evaluation (consistency, spreadability, uniformity, skin-following property, repeated detachability) and initial adhesion test, and the results showed that: the paste is formed, has proper consistency, spreading property, uniformity, skin following property and repeated stripping property, has initial adhesion of No. 12 small balls, and meets the requirement.
Example 5
Figure BDA0003296816890000061
A gel paste was prepared according to the preparation method of example 1. The obtained gel paste was subjected to sensory evaluation (consistency, spreadability, uniformity, skin-following property, repeated detachability) and initial adhesion test, and the results showed that: the paste is formed, has proper consistency, spreading property, uniformity, skin following property and repeated stripping property, has initial adhesion of No. 11 small balls, and meets the requirement.
Example 6
Figure BDA0003296816890000062
A gel paste was prepared according to the preparation method of example 1. The obtained gel paste was subjected to sensory evaluation (consistency, spreadability, uniformity, skin-following property, repeated detachability) and initial adhesion test, and the results showed that: the paste is formed, has proper consistency, spreading property, uniformity, skin following property and repeated stripping property, has initial adhesion of No. 11 small balls, and meets the requirement.
Example 7
Figure BDA0003296816890000063
A gel paste was prepared according to the preparation method of example 1. The obtained gel paste was subjected to sensory evaluation (consistency, spreadability, uniformity, skin-following property, repeated detachability) and initial adhesion test, and the results showed that: the paste is formed, has proper consistency, spreading property, uniformity, skin following property and repeated stripping property, has initial adhesion of No. 11 small balls, and meets the requirement.
Example 8
Figure BDA0003296816890000071
A gel paste was prepared according to the preparation method of example 1. The obtained gel paste was subjected to sensory evaluation (consistency, spreadability, uniformity, skin-following property, repeated detachability) and initial adhesion test, and the results showed that: the paste is formed, has proper consistency, spreading property, uniformity, skin following property and repeated stripping property, has initial adhesion of No. 11 small balls, and meets the requirement.
Example 9
Figure BDA0003296816890000072
A gel paste was prepared according to the preparation method of example 1. The obtained gel paste was subjected to sensory evaluation (consistency, spreadability, uniformity, skin-following property, repeated detachability) and initial adhesion test, and the results showed that: the paste is formed, has proper consistency, spreading property, uniformity, skin following property and repeated stripping property, has initial adhesion of No. 11 small balls, and meets the requirement.
Example 10
Figure BDA0003296816890000073
A gel paste was prepared according to the preparation method of example 1. The obtained gel paste was subjected to sensory evaluation (consistency, spreadability, uniformity, skin-following property, repeated detachability) and initial adhesion test, and the results showed that: the paste is formed, has proper consistency, spreading property, uniformity, skin following property and repeated stripping property, has initial adhesion of No. 12 small balls, and meets the requirement.
Example 11
Figure BDA0003296816890000074
Figure BDA0003296816890000081
A gel paste was prepared according to the preparation method of example 1. The obtained gel paste was subjected to sensory evaluation (consistency, spreadability, uniformity, skin-following property, repeated detachability) and initial adhesion test, and the results showed that: the paste is formed, has proper consistency, spreading property, uniformity, skin following property and repeated stripping property, has initial adhesion of No. 10 small balls, and meets the requirement.
Example 12
Figure BDA0003296816890000082
A gel paste was prepared according to the preparation method of example 1. The obtained gel paste was subjected to sensory evaluation (consistency, spreadability, uniformity, skin-following property, repeated detachability) and initial adhesion test, and the results showed that: the paste is formed, has proper consistency, spreading property, uniformity, skin following property and repeated stripping property, has initial adhesion of No. 10 small balls, and meets the requirement.
Example 13
Figure BDA0003296816890000083
A gel paste was prepared according to the preparation method of example 1. The obtained gel paste was subjected to sensory evaluation (consistency, spreadability, uniformity, skin-following property, repeated detachability) and initial adhesion test, and the results showed that: the paste is formed, has proper consistency, spreading property, uniformity, skin following property and repeated stripping property, has initial adhesion of No. 10 small balls, and meets the requirement.
Example 14
Figure BDA0003296816890000084
A gel paste was prepared according to the preparation method of example 1. The obtained gel paste was subjected to sensory evaluation (consistency, spreadability, uniformity, skin-following property, repeated detachability) and initial adhesion test, and the results showed that: the paste is formed, has proper consistency, spreading property, uniformity, skin following property and repeated stripping property, has initial adhesion of No. 11 small balls, and meets the requirement.
Example 15
Figure BDA0003296816890000091
A gel paste was prepared according to the preparation method of example 1. The obtained gel paste was subjected to sensory evaluation (consistency, spreadability, uniformity, skin-following property, repeated detachability) and initial adhesion test, and the results showed that: the paste is formed, has proper consistency, spreading property, uniformity, skin following property and repeated stripping property, has initial adhesion of No. 11 small balls, and meets the requirement.
Example 16
Figure BDA0003296816890000092
A gel paste was prepared according to the preparation method of example 1. The obtained gel paste was subjected to sensory evaluation (consistency, spreadability, uniformity, skin-following property, repeated detachability) and initial adhesion test, and the results showed that: the paste is formed, has proper consistency, spreading property, uniformity, skin following property and repeated stripping property, has initial adhesion of No. 11 small balls, and meets the requirement.
Experimental example 1 analgesic experiment of Aconitum carmichaeli gel patch
1 materials and methods
1.1 materials
Experimental drugs: raw aconite group (prepared as described in example 1), raw aconite (prepared as described in example 2), black aconite group (prepared as described in example 3), aconite stem and leaf group (prepared as described in example 4), prepared aconite group (prepared as described in example 5), prepared aconite group (prepared as described in example 6), prepared aconite group (prepared as described in example 7), positive control group (compound redbud injury-eliminating babu plaster: shanghai traditional Chinese medicine pharmaceutical three factories);
1.2 groups of Experimental animals
Grouping experimental animals: SPF-grade Kunming mice (provided by laboratory animal research institute of Sichuan academy of medicine and sciences, quality certificate number: SCXK (Sichuan) 2013-15) with weight of 20-25 g and half of male and female, wherein the total number of 80 mice is randomly divided into 8 groups, namely a blank control group, a model control group, a positive control group and each administration group.
2 method of experiment
The mice in each experimental group are applied with the medicine 1 time at the back depilating position every day, the medicine is kept for 10 hours each time, the medicine is continuously administered for 3 days, 1 hour after the medicine is administered on the 4 th day, 1 percent glacial acetic acid solution (0.1mL/10g) is injected into the abdominal cavity, and after 10 minutes of intraperitoneal injection, the torsion reaction is positive by the repeated contraction of waist muscles, the inward concave of the abdomen, the stretching of the trunk and hind limbs, the rising of the hip and the like of the mice. The number of writhing reactions of each group of mice within 10min was observed and recorded.
The experimental data were analyzed using SPSS 22.0 software, with mean. + -. standard deviation
Figure BDA0003296816890000101
The significance levels are expressed as normalized by P < 0.05 and P < 0.01, with the results shown in Table 1.
Figure BDA0003296816890000102
3 results
By observation, the number of writhing reactions of the mice within 10min is shown in table 1.
TABLE 1 mouse ACETIC TOVOIDAL ANALGESIC TEST RESULTS (
Figure BDA0003296816890000103
n=10)
Figure BDA0003296816890000104
Compared with the model control group,*has significant difference (P)<0.05),**With a very significant difference (P)<0.01)
Compared with the positive control group, the test results show that,#has significant difference (P)<0.05),##With a very significant difference (P)<0.01)
The experimental result shows that compared with a blank control group, the writhing reaction times of mice in each group are obviously reduced (P is less than 0.01) after administration; compared with the model group, each plaster group has significant difference, which shows that each plaster administration group has better effect of inhibiting and easing pain; compared with a positive control group, the radix aconiti has obvious difference in each administration group, which shows that the analgesic effect of each group of radix aconiti gel plaster prepared by the invention is superior to the effect of the compound cercis chinensis trauma-eliminating cataplasm, and the pain-easing inhibition rate of the radix aconiti in each administration group of radix aconiti by the raw radix aconiti, the raw radix aconiti lateralis, the stem and leaf group of the radix aconiti to the acetic acid writhing of a mouse is high.
Experimental example 2 anti-inflammatory experiment of Sichuan aconite root gel emplastrum
1 materials of the experiment
1.1 materials
Experimental drugs: raw aconite group (prepared as described in example 1), raw aconite (prepared as described in example 2), black aconite group (prepared as described in example 3), aconite stem and leaf group (prepared as described in example 4), prepared aconite group (prepared as described in example 5), prepared aconite group (prepared as described in example 6), prepared aconite group (prepared as described in example 7), positive control group (compound redbud injury-eliminating babu plaster: shanghai traditional Chinese medicine pharmaceutical three factories);
1.2 groups of Experimental animals
Grouping experimental animals: SPF-grade Kunming mice (provided by laboratory animal research institute of Sichuan academy of medicine and sciences, quality certificate number: SCXK (Sichuan) 2013-15) with weight of 20-25 g and half of male and female, wherein the total number of the mice is 56, the mice are randomly divided into 8 groups, namely a blank control group, a model control group, a positive control group and each administration group.
2 method of experiment
The medicine is applied to the depilated part of the back of each experimental group for 1 time every day, the application is kept for 10 hours each time, the medicine is continuously applied for 3 days, after the medicine is applied for 1 hour on the fourth day, 50 mu l of dimethylbenzene is uniformly applied to the two sides of the right ear of the mouse (each side is 25 mu l), after 1 hour, the two ears are cut off, a 9mm hole puncher is used for taking the two ears off the same parts of the two ears, the two ears are placed on a precision balance for weighing, and the swelling degree and the swelling inhibition rate are calculated.
Swelling degree is equal to the weight of right ear and the weight of left ear
Figure BDA0003296816890000111
The experimental data were analyzed using SPSS 22.0 software, with mean. + -. standard deviation
Figure BDA0003296816890000112
Indicating that the significance levels were normalized to P < 0.05 and P < 0.01, the results are shown in Table 2.
3 results of the experiment
The results of ear swelling degree and swelling inhibition rate of the mice are shown in table 2 by weighing and calculating.
Table 2 mouse ear swelling test results (
Figure BDA0003296816890000121
n=7)
Figure BDA0003296816890000122
Compared with the model control group,*has significant difference (P)<0.05),**With a very significant difference (P)<0.01)
Compared with the positive control group, the test results show that,#has significant difference (P)<0.05),##With a very significant difference (P)<0.01)
The results show that compared with a blank control group, the model group has extremely significant difference, which indicates that the model is successfully manufactured; compared with the model group, each emplastrum group has significant difference, and the raw aconite group and the processed aconite group have significant difference, which shows that each emplastrum administration group has better effect on inhibiting the ear swelling of mice; compared with the positive group, the black shun tablet group and the processed radix aconiti lateralis preparata group have no significant difference, and the raw radix aconiti, the raw radix aconiti lateralis preparata group, the radix aconiti stem and leaf group, the processed radix aconiti preparata group and the processed radix aconiti lateralis preparata group have significant difference, which indicates that the anti-inflammatory effect of the black shun tablet group and the processed radix aconiti lateralis preparata group is similar to the effect of the compound cercis chinensis cataplasm for removing the injury, and the inhibition effect of other administration groups on the mouse ear swelling is better than that of the positive control group, especially the raw radix aconiti lateralis preparata group.

Claims (4)

1. A radix Aconiti extract gel patch comprises radix Aconiti Preparata extract gel,the gel emplastrum is characterized by comprising the following components: 60g of radix aconiti lateralis preparata extract, NP 7002 g, 0.06g of aluminum chloride, 30g of glycerol, 2g of kieselguhr, 4g of silicon dioxide, 2.5g of CMC-Na, 0.25g of carbomer and EDTA-Na20.1g, 0.15g tartaric acid and the balance of pure water; the preparation method of the radix aconiti lateralis preparata extract comprises the following steps: decocting the raw radix aconiti lateralis preparata slices for 4 hours by adding water, and concentrating an extracting solution into a medicine extract with the relative density of 1.10-1.20 at 60 ℃ after the extracting solution is opened; the preparation method of the gel emplastrum comprises the following steps:
a. preparing an oil phase: accurately weighing NP700, CMC-Na, carbomer, aluminum chloride and EDTA-Na according to the formula ratio2Glycerol, the substances are put in an open container to be stirred and dispersed evenly, and then the mixture is placed for standby;
b. preparing an aqueous phase: accurately weighing the raw radix aconiti lateralis preparata extract, the diatomite, the silicon dioxide and the tartaric acid according to the formula ratio, adding water and uniformly stirring;
c. preparing gel paste: slowly adding the water phase into the oil phase, rapidly stirring to form a viscous colloid with certain cohesion, uniformly coating the colloid on non-woven fabric, drying at 40 deg.C for 3 hr, taking out, recovering to normal temperature, cutting into rectangular bodies, and covering with a liner.
2. The method for preparing the radix aconiti extract gel emplastrum according to claim 1, wherein the rectangular parallelepiped in step c has any one of the specifications of 7 x 10cm, 8 x 12cm, 10 x 10cm and 10 x 14cm, and the thickness thereof is 0.5 to 1.0 cm.
3. The radix aconiti extract gel emplastrum as claimed in claim 1 or 2, characterized in that the application of the gel emplastrum in preparing anti-inflammatory and analgesic drugs.
4. The radix aconiti extract gel emplastrum as claimed in claim 1 or 2, characterized in that the application of the gel emplastrum in rheumatoid arthritis, rheumatoid arthritis and arthralgia.
CN202111180327.8A 2018-05-05 2018-05-05 Radix aconiti extract gel emplastrum and preparation method thereof Pending CN113679695A (en)

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