CN112439048A - A Chinese medicinal composition used as both medicine and food for relieving inflammation and pain or resisting bacteria, and its preparation method - Google Patents
A Chinese medicinal composition used as both medicine and food for relieving inflammation and pain or resisting bacteria, and its preparation method Download PDFInfo
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/906—Zingiberaceae (Ginger family)
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Abstract
The invention relates to an anti-inflammatory analgesic or antibacterial medicine and food dual purpose Chinese medicinal composition, which mainly comprises the following raw material medicaments in part by weight: 60-120 parts of dried ginger, 20-40 parts of pawpaw, 10-40 parts of angelica sinensis, 5-20 parts of orange peel, 5-20 parts of clove, 5-20 parts of angelica dahurica, 5-20 parts of anise, 5-20 parts of galangal, 5-20 parts of pepper, 5-20 parts of cinnamon, 5-20 parts of zaocys dhumnade, 5-20 parts of turmeric, 5-20 parts of rhizoma kaempferiae, 8-12 parts of gastrodia elata, 5-20 parts of fennel, 5-20 parts of peach kernel, 5-20 parts of hawthorn, 5-9 parts of eucommia ulmoides leaf, 8-12 parts of pepper and 8-12 parts of yellow mustard seed. The traditional Chinese medicine composition has the effects of warming channels for dispelling cold, dispelling wind and removing dampness, dredging collaterals, regulating qi-flowing for relieving pain and the like, has the characteristics of safety, effectiveness and convenience, and can be widely used as an external traditional Chinese medicine in the aspects of preventing and treating neck, shoulder, waist and leg pain, rheumatic arthritis, rheumatoid arthritis, traumatic injury, abdominal psychroalgia, external tumors and other diseases.
Description
Technical Field
The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to an anti-inflammatory, analgesic or antibacterial medicine and food dual-purpose traditional Chinese medicine composition and a preparation method thereof.
Background
External treatment with traditional Chinese medicine refers to a traditional medical method for preventing and treating diseases by using traditional Chinese medicine through non-oral administration methods of stimulating channels and collaterals, acupuncture points, skin, mucous membranes, muscles, bones and muscles and the like. The preparation is widely applied to dermatology, surgery and the like, can protect the skin, has local treatment effect on the skin or mucosa, and even can permeate the skin or the mucosa to have the systemic treatment effect. At present, compared with oral medicines, the traditional Chinese medicine external treatment method can be used for intensively treating the affected part, has less burden on the body and is safer. The transdermal drug delivery system using the plaster as the carrier becomes a new field in pharmaceutics, and has proved to have unique curative effect on a plurality of diseases, so the growth rate has the trend of exceeding oral administration and drug inhalation, and has wide market prospect.
Disclosure of Invention
The invention aims to overcome the defects of the prior art and provides a medicine and food dual-purpose traditional Chinese medicine composition for diminishing inflammation, relieving pain or resisting bacteria. The traditional Chinese medicine composition has the effects of warming channels for dispelling cold, dispelling wind and removing dampness, dredging collaterals and regulating qi, relieving swelling and pain and the like, has the characteristics of safety, effectiveness and convenience, and can be widely used as an external traditional Chinese medicine in the aspects of preventing and treating diseases such as neck, shoulder, waist and leg pain, rheumatic arthritis, rheumatoid arthritis, traumatic injury, abdominal psychroalgia, external tumors and the like.
The invention also provides a preparation method of the medicine and food dual-purpose Chinese medicinal composition.
In order to achieve the purpose, the invention adopts the following technical scheme:
a traditional Chinese medicine composition used as both medicine and food and having anti-inflammatory, analgesic or antibacterial effects mainly comprises the following raw material medicines in parts by weight:
60-120 parts of dried ginger, 20-40 parts of pawpaw, 10-40 parts of angelica sinensis, 5-20 parts of orange peel, 5-20 parts of clove, 5-20 parts of angelica dahurica, 5-20 parts of anise, 5-20 parts of galangal, 5-20 parts of pepper, 5-20 parts of cinnamon, 5-20 parts of zaocys dhumnade, 5-20 parts of turmeric, 5-20 parts of rhizoma kaempferiae, 8-12 parts of gastrodia elata, 5-20 parts of fennel, 5-20 parts of peach kernel, 5-20 parts of hawthorn, 5-9 parts of eucommia ulmoides leaf, 8-12 parts of pepper and 8-12 parts of yellow mustard seed.
The invention provides a preparation method of the anti-inflammatory, analgesic or antibacterial medicine and food dual-purpose traditional Chinese medicine composition, which comprises the steps of taking the medicines according to a certain proportion, placing the medicines into an extraction tank, heating and refluxing the medicines by using 70-80% ethanol, filtering an extracting solution (300 meshes), and concentrating the extracting solution under reduced pressure until the relative density is 1.4-1.6 to obtain the traditional Chinese medicine composition ointment.
The specific raw material medicine and 70-80% ethanol are mixed according to the solid-to-liquid ratio of 1 g: adding 5-8ml, extracting under reflux for 2-4 times (extraction temperature is 70-90 deg.C), each time for 2-4 hr. Vacuum concentrating at 50-70 deg.c and-0.07-0.09 MPa to recover solvent.
The invention also provides a preparation method of the anti-inflammatory, analgesic or antibacterial medicine and food dual-purpose traditional Chinese medicine composition, which comprises the following steps:
1) placing the above materials in an extraction tank, extracting with 70-80% ethanol under reflux, filtering the extractive solution, and concentrating under reduced pressure to relative density of 1.4-1.6 to obtain unguent;
2) melting 100kg of hot-melt pressure-sensitive adhesive at 300 ℃, adding 2.4kg of paste after the temperature is reduced to 175 ℃, and uniformly stirring; and coating the adhesive on a woven fabric by using a coating machine, wherein the thickness of the woven fabric is 0.5mm, the surface of the woven fabric is covered with ion paper, and the woven fabric is cut into a patch with the length and the width of 8 x 12cm, namely the hot melt pressure sensitive adhesive patch.
In addition, the traditional Chinese medicine composition can be prepared into a medicinal preparation together with conventional pharmaceutic adjuvants in pharmaceutics. The medicinal preparation can be external patch, external ointment, liniment, cataplasm, etc., can be made into patch of different shapes such as knee patch, cervical vertebra patch, navel patch, heel patch, foot patch, nose patch, acupoint patch, etc. according to different application parts of knee, cervical vertebra, lumbar vertebra, navel patch, heel patch, foot patch, nose patch, etc., and has effects of resisting inflammation, dredging collaterals, promoting blood circulation, dispelling cold, eliminating dampness, relieving pain, and treating diseases such as acute soft tissue injury, acute synovitis, abdominal pain, external tumor, etc.
According to the formula of the medicine-food dual-purpose traditional Chinese medicine composition for external treatment, the dried ginger is used as a monarch drug, and can increase local blood circulation to dissolve wind cold and stimulate hair follicles to open so as to play the roles of dispelling cold, relieving pain and removing moisture.
Clove, dahurian angelica root, cinnamon bark and gastrodia tuber are used as ministerial drugs. Wherein, the clove has the functions of warming the middle-jiao, lowering the adverse flow of qi, tonifying the kidney and supporting yang, and is a common medicine for treating the psychroalgia of the heart and the abdomen; the angelica dahurica is used for expelling wind-damp, promoting blood circulation, expelling pus, promoting granulation and relieving pain; the cassia bark recorded in the compendium of materia medica has the functions of strengthening bones and muscles, promoting blood circulation and guiding various medicines, has the functions of warming spleen and stomach, tonifying kidney, dispelling cold and relieving pain, and is a commonly used medicine for treating cold pain of waist and knees, deficiency-cold stomachache, chronic dyspepsia and abdominal pain; gastrodia elata, a common medicine for dispelling wind and eliminating dampness and warming and activating meridians and collaterals, is applied to traditional Chinese herbs in all ages, for example, Gastrodia elata recorded in Kaibao Bencao has the effects of treating various kinds of rheumatism, treating spasm of limbs … …, benefiting waist and knee, strengthening tendons and strengthening force, so that Gastrodia elata recorded in Yaobao Bencao has the effects of reducing body weight, activating meridian and benefiting waist and knee, and regulating blood vessels, and so on. The four medicines play the roles of dispelling cold, expelling wind, removing dampness, dredging collaterals and relieving pain together, are essential in the formula.
Fructus Chaenomelis, radix Angelicae sinensis, pericarpium Citri Tangerinae, fructus Anisi Stellati, rhizoma Alpiniae Officinarum, fructus Zanthoxyli, fructus Piperis, Zaocys, Curcuma rhizome, rhizoma Kaempferiae, fructus Foeniculi, semen Persicae, fructus crataegi, folium Eucommiae, Capsici fructus, and semen Brassicae Junceae as adjuvant drugs. The pawpaw has the effects of relaxing tendons and activating collaterals, harmonizing stomach and resolving dampness, and the pawpaw is recorded in the book Ben Cao Zheng (materia Medica) and is specially used for nourishing liver, tendons and blood; angelica sinensis, blood enriching and activating, menstruation regulating and pain relieving, amenorrhea and dysmenorrheal, deficiency cold and abdominal pain, rheumatic arthralgia and traumatic injury; haw, recorded in Shi Jian Ben Cao (herbal medicine for food identification), is used to treat blood clots, qi clots and promote blood circulation; pericarpium Citri Tangerinae, used in combination with fructus crataegi for regulating qi-flowing, invigorating spleen, eliminating dampness and phlegm, and treating dyspepsia, abdominal distention and pain, etc.; the anise is a good medicine for strengthening the stomach, expelling wind, easing pain, regulating the middle warmer, regulating the flow of qi and dispelling cold dampness, and is used for treating middle cold vomiting, abdominal cold pain and stomach swelling and stuffiness; galangal has the actions of dispelling cold and relieving pain, and the mutual reinforcement with ginger indicated in He Ji Ju Fang (pill of Alpinia officinarum and rhizoma Zingiberis recens) is a prepared pill for treating cold pain in stomach and abdomen; zanthoxylum bungeanum has the effects of warming the middle-jiao to dispel cold, removing dampness and relieving pain, and it is clearly indicated in the book of miscellaneous records that Zanthoxylum bungeanum can open the skin and skin striae, dredge blood vessels, strengthen the teeth and hair, regulate joints, resist cold and summer heat and be used as a plaster, and the book of property of the medicine records that it can treat aversion to wind and difficult paralysis of limbs; pepper, pungent in flavor and warm in nature, has the effects of warming the middle-jiao to dispel cold, descending qi and dissolving phlegm. Modern pharmacology indicates that pepper has activity in various aspects such as analgesia, sedation, cell protection, anti-inflammation, bacteriostasis, disinsection, anti-tumor and the like; zaocys dhumnades has the effects of dispelling wind-damp and dredging meridians, is recorded in Ben Cao gang mu of Li Shizhen, is mainly used for treating wind-evil, obstinate arthralgia and skin numbness, and is a preferred natural medicinal material for treating intractable diseases such as rheumatic arthritis, stroke, facial distortion, hemiplegia and the like; turmeric has the effects of promoting qi circulation, removing blood stasis, stimulating the menstrual flow and relieving pain, and is recorded in Yi Lin Du Yao (pharmaceutical Commission) to treat wind-cold-dampness arthralgia of limbs, mainly treat chest and abdomen distending pain, shoulder and arm pain, traumatic injury, tumor and the like; kaempferia galangal, pungent in flavor, warm middle energizer and resolve dampness, move qi and alleviate pain. Can be used for treating chest and abdomen psychroalgia, traumatic injury, etc.; fructus Foeniculi has effects of warming kidney for dispelling cold, regulating stomach and regulating qi-flowing, activating qi-flowing, dispelling cold, and relieving pain, and can be used for treating cold hernia, lower abdomen psychroalgia, lumbago due to kidney deficiency, and gastralgia; peach kernel, semen Persicae has effects of promoting blood circulation and removing blood stasis, and can be used for treating traumatic injury; eucommia bark leaf, eucommia bark. For liver and kidney deficiency, dizziness, soreness and pain of waist and knees, flaccidity of tendons and bones, it is recorded in Ben Cao gang mu Shi Yi that Chili can "dispel wind and promote blood circulation, dispel cold and remove stagnancy"; the mustard seed is a messenger drug, has the effects of promoting qi circulation, dissipating binds, dredging collaterals and relieving pain, is used for limb joint pain and numbness caused by phlegm-dampness blocking channels and collaterals, is matched with cinnamon, baked ginger, prepared rehmannia root and the like, has the functions of promoting blood circulation, dredging collaterals, dissipating phlegm and dissipating binds, has the foaming function when being externally applied, and can promote the drug to directly reach focus.
The invention adopts a model of swelling and pain of soles of mice (parasto Mojtahed, Zadeh-Ardabilia, Sima Kianpoor Rad, anti-pain and anti-inflammation effects of Neptune krill oil and fat oil obtained in animal tissue oil and fat oil induced inflammation in semiconductor modules: Current states and pilot states [ J ] Biotechnology Reports,2019,22:1-7.) to test and observe the prevention and treatment effects of the external application curative effect of the traditional Chinese medicine composition extract for medicine and food. The experimental results show that: after the medicine and food dual-purpose traditional Chinese medicine composition (one gram of ointment is equivalent to 3.2 grams of raw medicinal materials) provided by the invention is administrated, the sole swelling and pain index of a mouse with inflammatory pain can be obviously reduced.
The invention adopts a mouse auricle swelling model (Huang-he Yu, Ye Lin, Rong Zeng, et al, analytical and anti-inflammatory effects and molecular mechanisms of Kadsura hectare, an anti-inflammatory Chinese medicine and ethiometry pharmaceutical erb [ J ]. Journal of Ethnopharmacology,2019,238(28): 1-8), and experiments observe the prevention and treatment effects of the external application curative effect of the medicinal and edible Chinese medicinal composition extract provided by the invention. The experimental results show that: after the medicine and food dual-purpose traditional Chinese medicine composition (one gram of ointment is equivalent to 3.2 grams of raw medicinal materials) provided by the invention is administrated, the auricle swelling and pain index of a mouse with inflammatory pain can be obviously reduced.
Compared with the prior art, the technical scheme of the invention has the following obvious advantages:
1) the medicines in the prescription of the medicine-food dual-purpose traditional Chinese medicine external treatment composition belong to medicine-food homologous varieties published by the Wei-Jian Commission of the people's republic of China, and have the advantages of high raw material safety, wide application population, safe and convenient use and less clinical application side effects.
2) The invention adopts a formaldehyde foot licking experiment and a mouse auricle xylene inflammation experiment to observe the prevention and treatment effects of the medicine-food dual-purpose traditional Chinese medicine composition on pain and inflammation.
Detailed Description
The technical solution of the present invention is further described in detail with reference to the following examples, but the scope of the present invention is not limited thereto.
In the following examples, the parts of the raw materials added are all parts by weight unless otherwise specified.
Example 1
A traditional Chinese medicine composition used as both medicine and food and having anti-inflammatory, analgesic or antibacterial effects mainly comprises the following raw material medicines in parts by weight:
60 parts of dried ginger, 30 parts of pawpaw, 30 parts of angelica sinensis, 15 parts of orange peel, 15 parts of clove, 15 parts of angelica dahurica, 15 parts of anise, 15 parts of galangal, 15 parts of pepper, 15 parts of cinnamon, 15 parts of zaocys dhumnade, 15 parts of turmeric, 15 parts of rhizoma kaempferiae, 10 parts of gastrodia elata, 15 parts of fennel, 15 parts of peach kernel, 15 parts of hawthorn, 7 parts of folium cortex eucommiae, 10 parts of pepper and 10 parts of mustard seed.
A preparation method of the ointment of the anti-inflammatory, analgesic or antibacterial medicine and food dual-purpose traditional Chinese medicine composition comprises the following specific steps:
1) preparing an extracting solution: the raw materials are taken according to the proportion and placed in an extraction tank, and are heated and refluxed for extraction for 3 times by using 75% ethanol with 6 times (v/w) (namely, the raw material medicines and the 75% ethanol are added according to the solid-to-liquid ratio of 1 g: 6 ml) for 2 hours each time;
2) concentrating into paste: mixing the extractive solutions, filtering (300 mesh), concentrating the filtrate at 60 deg.C under reduced pressure (-0.09MPa) to recover solvent, and decocting to relative density of about 1.5 to obtain concentrated paste; each gram of the ointment contains about 3.2 g of medicinal materials.
Example 2:
a medical hot melt pressure sensitive adhesive plaster of a medical and edible dual-purpose traditional Chinese medicine composition and a preparation method thereof are as follows:
prescription: 60 parts of dried ginger, 30 parts of pawpaw, 30 parts of angelica sinensis, 15 parts of orange peel, 15 parts of clove, 15 parts of angelica dahurica, 15 parts of anise, 15 parts of galangal, 15 parts of pepper, 15 parts of cinnamon, 15 parts of zaocys dhumnade, 15 parts of turmeric, 15 parts of rhizoma kaempferiae, 10 parts of gastrodia elata, 15 parts of fennel, 15 parts of peach kernel, 15 parts of hawthorn, 7 parts of folium cortex eucommiae, 10 parts of pepper and 10 parts of yellow mustard seed, and the above medicines are crushed, uniformly mixed and sieved by a 350-mesh sieve to obtain the traditional Chinese medicine composition. The preparation method specifically comprises the following steps:
melting 100 parts of hot melt pressure sensitive adhesive (produced by Shanghai Tiandiao new material science and technology Co., Ltd.), melting at 300 deg.C, adding 3 parts of Chinese medicinal composition powder, rapidly stirring to mix uniformly, standing for 4 hr, cooling to 175 deg.C, adding 0.1 part of Borneolum Syntheticum, rapidly stirring uniformly, coating the mixture on a woven fabric with a thickness of 0.5mm, covering the surface with ion paper, and cutting into patches with length and width of 8 x 12 cm.
Example 3:
a hot melt pressure sensitive adhesive plaster of a Chinese medicinal composition used as both medicine and food and a preparation method thereof are as follows:
prescription: 60 parts of dried ginger, 30 parts of pawpaw, 30 parts of angelica sinensis, 15 parts of orange peel, 15 parts of clove, 15 parts of angelica dahurica, 15 parts of anise, 15 parts of galangal, 15 parts of pepper, 10 parts of pepper, 15 parts of cinnamon, 15 parts of zaocys dhumnade, 15 parts of turmeric, 15 parts of rhizoma kaempferiae, 10 parts of gastrodia elata, 15 parts of fennel, 15 parts of peach kernel, 15 parts of hawthorn, 7 parts of folium cortex eucommiae, 10 parts of pepper and 10 parts of mustard seed. The preparation method specifically comprises the following steps:
1) preparing 2.4kg of paste according to the method of the embodiment 1 for later use;
2) melting 100kg of hot melt pressure sensitive adhesive at 300 ℃, adding the paste and stirring uniformly after the temperature is reduced to 175 ℃. Coating the mixture on a woven fabric by using a coating machine, wherein the thickness is 0.5mm, the surface of the woven fabric is covered with ion paper, and then cutting the woven fabric into patches with the length and the width of 8 x 12cm to obtain the adhesive patches.
Example 4:
a medicine and food dual purpose Chinese medicinal composition external ointment and its preparation method are as follows:
prescription: 60 parts of dried ginger, 30 parts of pawpaw, 30 parts of angelica sinensis, 15 parts of orange peel, 15 parts of clove, 15 parts of angelica dahurica, 15 parts of anise, 15 parts of galangal, 15 parts of pepper, 10 parts of pepper, 15 parts of cinnamon, 15 parts of zaocys dhumnade, 15 parts of turmeric, 15 parts of rhizoma kaempferiae, 10 parts of gastrodia elata, 15 parts of fennel, 15 parts of peach kernel, 15 parts of hawthorn, 7 parts of folium cortex eucommiae, 10 parts of pepper and 10 parts of mustard seed. The preparation method specifically comprises the following steps:
1) preparing 20 parts of ointment, 10 parts of anhydrous lanolin and 100 parts of vaseline for later use according to the method in the embodiment 1;
2) placing the paste into a mortar, adding sterilized vaseline and anhydrous lanolin cooled to 55-65 deg.C, and grinding.
Example 5:
a medicinal and edible Chinese medicinal composition hydrogel and its preparation method are provided, which comprises:
prescription: 60 parts of dried ginger, 30 parts of pawpaw, 30 parts of angelica sinensis, 15 parts of orange peel, 15 parts of clove, 15 parts of angelica dahurica, 15 parts of anise, 15 parts of galangal, 15 parts of pepper, 15 parts of cinnamon, 15 parts of zaocys dhumnade, 15 parts of turmeric, 15 parts of rhizoma kaempferiae, 10 parts of gastrodia elata, 15 parts of fennel, 15 parts of peach kernel, 15 parts of hawthorn, 7 parts of folium cortex eucommiae, 10 parts of pepper and 10 parts of mustard seed. The preparation method specifically comprises the following steps:
1) 10 parts of a paste, 10 parts of a crosslinked sodium polyacrylate (SDB-L-400, manufactured by Zhengzhou Bill chemical products Co., Ltd.), 10 parts of PEG-400080 parts and 100 parts of glycerin were prepared for use in the same manner as in example 1;
2) weighing PEG-4000 and glycerol, placing in a beaker, heating slightly until completely dissolving, adding the paste, and mixing;
3) adding 800 parts of water (60 ℃) into SDB-L-400, and uniformly grinding in a mortar to prepare a hydrogel matrix;
4) and (3) uniformly mixing the hydrogel matrix obtained in the step 3) and the product obtained in the step 2).
Note: SDB-L-400 is a high water-absorbing resin material, can absorb 200-300 times of self weight in 90 seconds and can expand into a colloidal semi-solid, and the embodiment takes the SDB-L-400 as a substrate, so that the SDB-L-400 can play roles in moisturizing, thickening and infiltrating skin; PEG-4000 is used as transdermal absorption enhancer.
Application test 1: bacteriostatic activity experiment of medicine and food dual-purpose traditional Chinese medicine composition
1. Experimental strains: coli ATCC 25922, Staphylococcus aureus ATCC6538 and Candida albicans ATCC10231, all purchased from Nanjing fecal Biotech Ltd.
2. The experimental method comprises the following steps: determination of the bacteriostatic Activity of the extract obtained in example 1 by the Filter paper sheet method
Firstly, a plurality of circular filter paper sheets with the diameter of 6mm are prepared and sterilized. Clamping with sterile forceps, respectively adding into the concentrated paste aqueous solution of example 1 with concentration of 0.1g/mL, 0.4g/mL, and 1g/mL, soaking for 2 hr, taking out, and air drying under sterile condition. Putting the sterilized culture dishes and MH agar culture medium into a clean bench, cooling to 60 ℃, pouring plates with about 20mL of each dish, horizontally placing the culture dishes after pouring, and solidifying the culture medium. 0.2mL of the bacterial suspension was pipetted onto the plate and spread evenly with a spreading bar. The air-dried filter paper pieces are clamped by tweezers and placed on a seeded flat plate, 3 filter paper pieces are placed in each dish in an equilateral triangle shape and are parallel to each other, the dish is placed in an incubator and is inversely cultured for 24 hours at 37 ℃, and the diameter of a bacteriostatic circle is measured.
3. Judging the index: and determining the sensitivity according to the diameter of the inhibition zone. The diameter of the inhibition zone is less than 10mm, the resistance is drug resistance, the moderate sensitivity is 10-15 mm, and the high sensitivity is more than 15 mm.
4. The results are shown in Table 1.
TABLE 1 bacteriostatic activity of the extract obtained in example 1 against three common bacteria
Note: the diameter of the inhibition zone in the table is the average measurement value of three parallel experiments
As can be seen from the results in Table 1, the extract obtained in example 1 is highly sensitive to three common bacteria at a medium dose (0.4g/mL) and a high dose (1g/mL), and the bacteriostatic effect is enhanced with the increase of the dose, which indicates that the extract obtained in example 1 has a better inhibitory effect on three common bacteria.
Application test 2: experiments on mouse formaldehyde licking foot of medicinal and edible traditional Chinese medicine composition
2.1 Experimental animals
Female mice of Kunming species were provided by Schlekschada laboratory animals Co., Ltd, Hunan (Lot #43004700058462, laboratory animal license number: SCKX (Hunan) 2016-.
2.2 Experimental modeling and drug administration
The mice were randomly divided into three groups of 20 mice each. Depilatory cream is applied to both sides of the spine of the mouse for 5min and then cleaned with gauze. Each group of mice was coated with the drugs on the hair removal area (0.2 mL/mouse of physiological saline for the blank control group, 0.2 g/mouse of hydrocortisone for the positive control group, and 0.2 g/mouse of the concentrated cream in example 1 for the experimental group), continuously for 7 days, and after the mice were administered for 1 hour on day 7, 0.04 mL/mouse of formaldehyde solution of 2.5mL/L was injected on the left rear sole, and immediately timed.
2.3 Observation index
The cumulative time of left hind paw licking and left hind paw withdrawal of mice within 0-5min and 20-30min after injection was recorded separately and the differences between groups were compared.
2.4 results of the experiment
Statistical analysis of the experimental data was performed using SPSS 17.0 for t-test, and differences were considered statistically significant when P < 0.05. The results are shown in Table 2.
TABLE 2 Effect of groups of drugs on the Formaldehyde pain test in mice
*Comparison with blank control group P<0.05
The results in table 2 show: compared with a blank control group, the times of licking the feet of the positive control group and the experimental group of mice are obviously reduced within a time period of 0-5min, and the times of licking the feet of the experimental group of mice are less than those of the positive drug control group within a time period of 20-30min, which shows that the concentrated ointment in the embodiment 1 has good anti-inflammatory and analgesic effects on the model mice.
Application test 3: experiment of inflammation caused by xylene in mouse auricle of medicinal and edible traditional Chinese medicine composition
3.1 Experimental animals
Female mice of Kunming species were provided by Schlekschada laboratory animals Co., Ltd, Hunan (Lot #43004700058462, laboratory animal license number: SCKX (Hunan) 2016-.
3.2 Experimental modeling and drug administration
The mice were randomly divided into three groups of 6 mice each. Depilatory cream is applied to both sides of the spine of the mouse for 5min and then cleaned with gauze. Each group of mice is coated with drugs in a depilation area (a blank control group is coated with physiological saline 0.2 mL/mouse, a positive control group is coated with hydrocortisone 0.2 g/mouse, an experimental group is coated with concentrated cream 0.2 g/mouse in example 1), the drugs are continuously coated for 7 days, after the mice are administered for 1h on the 7 th day, the right two sides of the mice are coated with xylene 36 μ l respectively, the left ear is used as a control, and the mice are dislocated and killed after 30 min.
3.3 Observation index
Cutting two ears along the base line of auricle, respectively punching round ear pieces at the same position with a puncher with diameter of 8mm, weighing with an electronic balance, and calculating swelling degree and swelling inhibition rate.
Swelling degree is the right ear weight-left ear weight.
The swelling inhibition rate is (average swelling degree of blank control group-average swelling degree of administration group)/average swelling degree of blank control group × 100%.
3.4 results of the experiment
Statistical analysis of the experimental data was performed using SPSS 17.0 for t-test, and differences were considered statistically significant when P < 0.05. The results are shown in Table 3.
TABLE 3 Effect of each group of drugs on xylene-induced ear swelling in mice
*Comparison with blank control group P<0.05
The results in table 3 show: compared with a blank control group, the auricle swelling degrees of the mice of the positive control group and the experimental group are obviously reduced, and the auricle swelling inhibition rate of the mice of the experimental group is higher than that of the mice of the positive control group, which indicates that the concentrated ointment in the example 1 has good anti-inflammatory and swelling-relieving effects on the model mice.
Application test 4: acute soft tissue injury test
4.1 Experimental animals
SD rats were provided by Schlekstaka laboratory animals Ltd, Hunan (Lot #43004700058462, laboratory animal license number: SCKX (Hunan) 2016-.
4.2 Experimental modeling and drug administration
The left hind leg of the SD rat was clipped out of the rat 1 day before the experiment and then the left hind leg of the rat was removed with 8% sodium sulfide solution. Marking the outer side of the middle part of the left hind limb, carrying out intraperitoneal injection anesthesia (0.7 mL/rat) on the rat by using a 10% chloral hydrate solution, fixing the rat on a rat board after anesthesia, fixing a marked part on a soft tissue impactor table, vertically placing a hollow tube with the height of 100cm and the diameter of 1.2cm at the marked part, continuously striking the marked left hind limb soft tissue for 3 times by using a weight with the mass of 100g along the free falling body of the hollow tube, and causing obvious subcutaneous bleeding and swelling at the struck part. 30 rats with the weight of about 180-220 g and half male and female parts successfully modeled in a local acute soft tissue injury model are taken and randomly divided into a blank control group, a positive control group (Xiaoshangtong liniment, Chinese medicine standard Z10880032, Yang Zhongzhi pharmaceutical industry Limited responsibility company) and an experimental group, wherein each group contains 10 rats, each group takes a striking part as the center, corresponding medicines are smeared on the rats (0.2 mL/one of 0.9% physiological saline is given to the blank control group, the administration dose of the Xiaoshangtong liniment is 0.046 g/one, and the administration dose of the experimental group is 0.4 g/one of the concentrated ointment in the embodiment 1), taking the degree of covering the damaged part, fixedly administering the medicine for 1 time/d by using gauze and a breathable adhesive tape, continuously administering the medicine for 5 days after molding every day, removing the medicine 6 hours after the medicine is administered every day, observing the swelling and fading conditions of ecchymosis, and scoring according to a scoring standard table (shown in a table 4) of the ecchymosis of the local soft tissue injury.
TABLE 4 Scoring standard table for soft tissue injury ecchymoses
4.3 results of the experiment
Statistical analysis of the experimental data was performed using SPSS 17.0 for t-test, and differences were considered statistically significant when P < 0.05. The results are shown in Table 5.
TABLE 5 Effect of extracts on acute Soft tissue injury in rats
Note: n is equal to 10, and n is equal to 10,*，**respectively represent comparison with blank control group P<0.05，P<0.01。
The results in table 5 show: compared with a blank control group, the acute soft tissue injury degree of the positive control group and the test group is obviously reduced, and the treatment effect of the experimental group is better than that of the positive control group rat, which shows that the concentrated ointment in the embodiment 1 has good treatment effect on the acute soft tissue injury model rat.
Application test 5: clinical test of hot-melt pressure-sensitive adhesive plaster of medicine and food dual-purpose traditional Chinese medicine composition for preventing and treating neck, shoulder, waist and leg pains
5.1 data and methods
The hot melt pressure sensitive adhesive plaster is used for preventing and treating 100 patients with neck, shoulder, waist and leg pain, and clinical observation is carried out on 54 male patients and 46 female patients, wherein the age of the male patients is between 28 and 94 years, and the average age of the female patients is 46 years.
5.2 the diagnosis standard meets the middle cold-dampness type related diagnosis standard of the Chinese clinical disease diagnosis curative effect standard, and the patients show that the neck, shoulder, waist and leg are acid and swollen, pain, turn to the side is unfavorable, the patients feel cold and aggravate, the limbs are cold and the like.
5.3 inclusion and exclusion standard inclusion standard, namely, meeting the diagnosis standard; secondly, the consciousness is clear, and the communication can be carried out automatically; voluntarily participating and signing an informed consent. The elimination standard is that the liver, kidney, heart and lung are combined to have abnormal functions or organic lesions; ② there is operation history of neck, shoulder, waist and leg; ③ accompanied with proliferative spondylitis, spinal stenosis, intraspinal lesions and other lumbar diseases; and fourthly, the patient can not be matched with the treatment.
5.4, method: a multicenter random single-blind parallel control method is adopted, random numbers are generated by a random number table (refer to medical experiment design and statistical analysis), and a test group and a control group are regulated, wherein each group comprises 50 cases. Experimental groups: the medicinal and edible traditional Chinese medicine composition hot-melt pressure-sensitive adhesive prepared in the embodiment 3 is pasted on an affected part once a day, and each time lasts for 12 hours. Control group: the appearance of the plaster is consistent with that of the plaster in the example 3, but the traditional Chinese medicine composition is not contained. The experiment was observed 3 days later.
5.5 observation indexes and judgment standards: the two groups of patients were observed continuously and the treatment effect and the basal disease pain score were recorded for both groups of patients. The clinical curative effect is that the clinical symptoms such as neck, shoulder, waist and leg pains and the like are completely disappeared, the limb movement is not limited, and the recovery is realized after the normal recovery; the clinical symptoms such as neck, shoulder, waist and leg pains and the like are obviously improved, and the limb movement is basically recovered to be obvious; the symptoms of neck, shoulder, waist and leg pain are improved, and the limb movement is improved to be effective; neither clinical symptoms nor limb movement were restored to ineffectiveness.
5.6 results
The statistical method comprises the following steps: the data processing is carried out by adopting SPSS 17.0 software, the counting data is expressed by percentage and Chi is adopted2The test shows that the difference is statistically significant when P is less than 0.05. The results are shown in Table 6.
TABLE 6 statistics of clinical effects
As can be seen from Table 6, the total effective rate of the treatment in the experimental group was higher than that in the control group, and the difference was statistically significant (P < 0.05).
Claims (4)
1. A traditional Chinese medicine composition with anti-inflammatory, analgesic or antibacterial effects and used as both medicine and food is characterized by mainly comprising the following raw material medicines in parts by weight: 60-120 parts of dried ginger, 20-40 parts of pawpaw, 10-40 parts of angelica sinensis, 5-20 parts of orange peel, 5-20 parts of clove, 5-20 parts of angelica dahurica, 5-20 parts of anise, 5-20 parts of galangal, 5-20 parts of pepper, 5-20 parts of cinnamon, 5-20 parts of zaocys dhumnade, 5-20 parts of turmeric, 5-20 parts of rhizoma kaempferiae, 8-12 parts of gastrodia elata, 5-20 parts of fennel, 5-20 parts of peach kernel, 5-20 parts of hawthorn, 5-9 parts of eucommia ulmoides leaf, 8-12 parts of pepper and 8-12 parts of yellow mustard seed.
2. The preparation method of the anti-inflammatory, analgesic or antibacterial pharmaceutical and edible traditional Chinese medicine composition as claimed in claim 1, wherein the above raw materials are taken in proportion and placed in an extraction tank, the mixture is heated and refluxed with 70-80% ethanol for extraction, and the extract is filtered and concentrated under reduced pressure until the relative density is 1.4-1.6, so as to obtain the traditional Chinese medicine composition ointment.
3. The preparation method of the anti-inflammatory, analgesic or antibacterial pharmaceutical and edible traditional Chinese medicine composition as claimed in claim 2, wherein the ratio of the bulk drug to 70-80% ethanol is 1 g: adding 5-8 ml; reflux extracting for 2-4 times, each for 2-4 hr.
4. The preparation method of the anti-inflammatory, analgesic or antibacterial drug and food dual purpose Chinese medicinal composition as claimed in claim 1, which comprises the following steps:
1) placing the above materials in an extraction tank, extracting with 70-80% ethanol under reflux, filtering the extractive solution, and concentrating under reduced pressure to relative density of 1.4-1.6 to obtain unguent;
2) melting 100kg of hot-melt pressure-sensitive adhesive at 300 ℃, adding 2.4kg of paste after the temperature is reduced to 175 ℃, and uniformly stirring; and coating the adhesive on a woven fabric by using a coating machine, wherein the thickness of the woven fabric is 0.5mm, the surface of the woven fabric is covered with ion paper, and the woven fabric is cut into a patch with the length and the width of 8 x 12cm, namely the hot melt pressure sensitive adhesive patch.
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