CN102579726A - Chinese medicinal compound gel for treating osteoarthrosis and preparation method thereof - Google Patents
Chinese medicinal compound gel for treating osteoarthrosis and preparation method thereof Download PDFInfo
- Publication number
- CN102579726A CN102579726A CN2012100460699A CN201210046069A CN102579726A CN 102579726 A CN102579726 A CN 102579726A CN 2012100460699 A CN2012100460699 A CN 2012100460699A CN 201210046069 A CN201210046069 A CN 201210046069A CN 102579726 A CN102579726 A CN 102579726A
- Authority
- CN
- China
- Prior art keywords
- extract
- gel
- chinese medicine
- medicine compound
- radix aconiti
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Landscapes
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
The invention relates to the technical field of pharmacy, and discloses a Chinese medicinal compound gel for treating osteoarthrosis and a preparation method thereof. Unprocessed radix aconite, arisaema consanguineum schott, musk and the like are used as main drugs, a modern preparation technology is adopted to extract and refine the main drugs to prepare an external gel. Irritation to gastrointestinal tracts caused by oral administration can be avoided, the blood concentration of the whole body is reduced, and toxic or side effect is reduced; and the preparation method is simple and convenient for using, so that the administration compliance of the patient is improved, and a new medicament is provided for clinical treatment of osteoarthrosis.
Description
Technical field
The present invention relates to field of medicaments, relate in particular to a kind of Chinese medicine compound gel of treating osteoarthritis and preparation method thereof.
Background technology
Osteoarthritis (diseases such as hyperosteogeny, intervertebral disk hernia) is clinical common with multiple difficult and complicated illness, belongs to Chinese medicine arthromyodynia category.Epidemiological study shows; Incidence rate that should disease in China's mid-aged population is up to 70%, and wherein cervical vertebra, lumbar vertebra and kneed sickness rate are the highest, and the three amounts to and accounts for more than 90% of osteoarthrosis; Along with China steps into aging society gradually, this problem will be more outstanding.
The method of existing treatment osteoarthritis, doctor trained in Western medicine often adopt oral nonsteroidal antipyretic analgesic or operative therapys such as " tractions ".The oral drugs side effect is many; The operative treatment cycle is long, expense is high, misery is big, and is prone to recurrence.Chinese medicine is unique advantage aspect the treatment osteoarthritis, and extract oral, external application, fumigation and wash method, acupuncture, moxibustion and small needle knife therapy all have positive effect.But oral preparation of Chinese traditional medicinal contains hypertoxic medicines such as Radix Aconiti, Rhizoma Arisaematis, Semen Strychni more, and dosage is difficult to grasp, and sees that from the biopharmaceutics angle being difficult in diseased region reaches effective blood drug concentration, has influenced the performance of curative effect of medication.
Chinese medicine " inner disease outer treat " is theoretical with a long history, has accumulated a large amount of good recipes, proved recipe, but external treatment with Chinese medicine medicine ubiquity dosage form falls behind; Dosage is big; Use shortcomings such as inconvenience, therefore utilize modern preparation technique exploitation evident in efficacy lasting, Chinese medicine for outer use easy to use is particularly important.
Summary of the invention
An object of the present invention is to provide a kind of Chinese medicine compound gel that improves affected part drug level, toxic and side effects is little, relapse rate is low, easy to use treatment osteoarthritis.
The present invention is refining through extracting with Chinese medicine; Adopt modern preparation process to process the external-use gel preparation; Embrocate administration through skin or mucosa; Gel can be avoided the contingent liver first-pass effect of oral administration through skin (or mucosa) administration and gastrointestinal is stimulated, and reduces systemic blood concentration, reduces central inhibitory action; Improve the drug level in local affected parts such as skin, nasal mucosa; And have the minimizing administration number of times, and easy to use, improve the advantages such as compliance of patient's medication.Gel of the present invention not only can keep its excellent curative, and can reduce its untoward reaction.
Chinese medicine compound gel of the present invention also can contain nertralizer and penetration enhancer by being processed by medicine, polymer-based material, antiseptic, wetting agent and solvent.
Medicine comprises Radix Aconiti extract, the Rhizoma Arisaematis extract, Camphora, Moschus moschiferous perfume; Polymer-based material is selected from any in carbopol, sodium carboxymethyl cellulose, hypromellose, hydroxypropyl cellulose, the polyvinylpyrrolidone; Wetting agent is a glycerol; Antiseptic is selected from ethyl hydroxybenzoate, benzalkonium bromide, EDTA-Na
2In any; Solvent is a distilled water.
Each components contents is in every 100g gel: Radix Aconiti extract 1.5g, and Rhizoma Arisaematis extract 1g, Camphora 0.1g, Moschus 0.04g, polymer-based material 0.1-5g, wetting agent 5-15ml, antiseptic 0.01-0.5g, all the other are solvent.
As preferably, polymer-based material is a carbopol, must add nertralizer, and nertralizer is selected from sodium hydroxide or triethanolamine, and the nertralizer consumption is the 0.04-6% of gel weight.
As preferably, also contain penetration enhancer in the polymer-based material, penetration enhancer is selected from azone, limonene, propylene glycol, can select 1-2 kind chemical compound wherein simultaneously for use, and the penetration enhancer consumption is the 0.5-20% of gel weight.
As preferably, each components contents is in every 100g gel: Radix Aconiti extract 1.5g, Rhizoma Arisaematis extract 1g, Camphora 0.1g, Moschus 0.04g, carbopol 1g, propylene glycol 10ml, triethanolamine 1.5g, EDTA-Na
20.05g, glycerol 5ml, all the other are solvent.
Radix Aconiti another name goose is spent, the ornamental work of iron, the five poisonous creatures: scorpion, viper, centipede, house lizard, toad, is the parent root of ranunculaceae plant Ka Shi Aconitum carmichjaelii Debx. AconitumcarmichaeliDebx..Feeble QI, acrid in the mouth, numb tongue, expelling wind and removing dampness, antalgic.Being used for anemofrigid-damp arthralgia, arthralgia, trusted subordinate's cold type of pain, colic of cold type has a pain.
The Rhizoma Arisaematis medical material is the dry tuber of aroid Rhizoma Arisaematis Arisaema erubescens (Wall.) Schott., Arisaema heterophyllum B1. Arisaema heterophyllum Blume or arisaema amurense Maxim Arisaema amurense Maxim., another name Rhizoma Arisaematis, white Rhizoma Arisaematis, mountain maize, Serpentis Semen Maydis, mountain ear of maize.Have drying dampness to eliminate phlegm, expelling wind and relieving convulsion, the function of mass dissipating and swelling eliminating.
Camphora is called splendid brain, camphor, brain, oily brain, tree brain, orifice opening; Qi stagnation removing; Ward off foul; Killing parasites for relieving itching; Reducing swelling and alleviating pain.Camphora is applied to skin has gentle stimulation and antisepsis. and firmly embrocated and sent out effect red. can stimulate Cold receptor and refrigerant sense is arranged, can antipruritic pain relieving.
Moschus has special fragrance, and bitterness is arranged, and can process spice, also can be used as medicine.Be the central nervous excitation agent, external can be eased pain, subsided a swelling.Be called for short " Moschus moschiferous ".Moschus is very famous and precious medical material, contains the abundant nutrition composition; Moisture 22.66%, ash 8.62% (wherein containing potassium, sodium, calcium, magnesium, chlorine, sulfate radical, phosphate radical etc.), the chlorine-containing compound (ammonia 1.89% in middle carbonated ammonium 1.1%, the ammonium salt.Carbamide 0.4%, amino acid nitrogen 1.077%, total nitrogen 6.16%), cholesterol 2.19%, crude fibre 0.59%, fatty acid 5.15%, muscone 1.2%.Moschus property is hot, warm, nontoxic, bitter in the mouth.Go into the heart, spleen, Liver Channel, the function of having one's ideas straightened out, warding off dirty, collateral dredging, loosing silt is arranged.Cure mainly apoplexy, syncope due to accumulation of phlegm, infantile convulsion, attacked by pestiferous factors unhappiness, trusted subordinate's sudden pain, traumatic injury, swollen ulcer drug.
Carbopol (carbopol, another name: carbomer; Carboxypoly methylene; Carboxyvinyl polymer) be by acrylic crosslinking polymer with gather alkyl sucrose or gather the copolymer of alkyl tetramethylolmethane.
Sodium carboxymethyl cellulose is the sodium salt of carboxymethyl cellulose ether, belongs to the anionic cellulose ether, is white or milky fibrous powder or granule, density 0.5-0.7 gram/cubic centimetre, odorless, tasteless almost, tool hygroscopicity.Be easy to be dispersed in the transparent colloidal solution of one-tenth in the water, insoluble in organic solvents such as ethanol.
EDTA-Na
2The chinesization formal name used at school is a disodium EDTA, and disodium EDTA is good chelating agent (chelating agen), is mainly used in water softening, effectively the multiple metal ion in the chelating hard water (mainly being calcium, magnesium and ferrum, lead, copper, manganese etc.).These article are as water softener, stabilizing agent, synthetic rubber, polymerization initiator and heavy metal quantitative analysis agent etc. in the bleach-fixing liquid of color sensitive material washing processing and dyeing assistant, fibre finish, cosmetics additive, medicine, food, the little fertile production of agriculture chemistry, blood anticoagulant, the detergent.
Glycerol is glycerin, is the achromatism and clarity thick liquid.
Another object of the present invention provides a kind of method for preparing of treating the Chinese medicine compound gel of osteoarthritis.
The method for preparing of Chinese medicine compound gel of the present invention is: polymer-based material is added water-soluble expanding; Radix Aconiti extract, the Rhizoma Arisaematis extract, Camphora are with 70% dissolve with ethanol; Moschus adds medicine, wetting agent, antiseptic with ether dissolution respectively by said ratio, and solubilizer is to ormal weight; Stir, gel.
As preferably, Radix Aconiti preparation method of extract: the Radix Aconiti pulverizing medicinal materials is become coarse powder, adopt 70% acidic ethanol (pH=3) percolation to extract, collects 8 times and measure percolates; With the percolate decompression recycling ethanol, water-bath is concentrated into relative density 1.05～1.07 (60 ℃ of heat are surveyed), filters, and filtrating is with ammonia adjust pH 9～10; Chloroform extraction 5 times, to the inanimate object alkali reaction, combining extraction liquid reclaims chloroform; Get clear paste, 60 ℃ of drying under reduced pressure promptly get the Radix Aconiti extract.Coarse powder is meant and can be no more than 20% powder through No. three sieves but be mixed with all through a sieve; Sieve 10 orders, sieve aperture internal diameter 2000 μ m ± 70 μ m, No. three sieve 50 orders, sieve aperture internal diameter 355 μ m ± 13 μ m.
As preferably, the method for preparing of the Rhizoma Arisaematis extract: with the Rhizoma Arisaematis pulverizing medicinal materials, adopt 70% acidic ethanol (pH=3) percolation to extract, collects 10 times and measure percolates; With the percolate decompression recycling ethanol, water-bath is concentrated into relative density 1.05～1.07 (60 ℃ of heat are surveyed), and adjust pH 2～3 filters; Filtrating is with ammonia adjust pH 9～10, and chloroform extraction 5 times is to inanimate object alkali reaction, combining extraction liquid; Reclaim chloroform, get clear paste, 60 ℃ of drying under reduced pressure promptly get the Rhizoma Arisaematis extract.
The present invention processes gel with the Chinese medicine compound recipe, embrocates administration through skin, not only can avoid the GI irritation of oral administration; Reduce systemic blood concentration, reduce toxic and side effects, and prolonged action time; Reduce administration number of times, improved the compliance of patient's medication.This formulation preparation method is simple, and is easy to use, for the clinical treatment of osteoarthritis provides a kind of new medicine.
The specific embodiment
Mode through embodiment further specifies the present invention below, and therefore scope of the present invention is not confined to following embodiment, but is limited description of the present invention and claims.
Embodiment 1
The Chinese medicine compound gel of preparation treatment osteoarthritis.
The prescription of Chinese medicine compound gel of the present invention and proportioning:
Radix Aconiti preparation method of extract: the Radix Aconiti pulverizing medicinal materials is become coarse powder, adopt 70% acidic ethanol (pH=3) percolation to extract, collects 8 times and measure percolates, with the percolate decompression recycling ethanol; Water-bath is concentrated into relative density 1.05 (60 ℃ of heat are surveyed), filters, and filtrates with ammonia adjust pH 9 chloroform extraction 5 times; To the inanimate object alkali reaction, combining extraction liquid reclaims chloroform; Get clear paste, 60 ℃ of drying under reduced pressure promptly get the Radix Aconiti extract.
The method for preparing of the Rhizoma Arisaematis extract: with the Rhizoma Arisaematis pulverizing medicinal materials, adopt 70% acidic ethanol (pH=3) percolation to extract, collect 10 times of amount percolates, with the percolate decompression recycling ethanol; Water-bath is concentrated into relative density 1.05 (60 ℃ of heat are surveyed), and adjust pH 2 filters, and filtrating is with ammonia adjust pH 9; Chloroform extraction 5 times, to the inanimate object alkali reaction, combining extraction liquid reclaims chloroform; Get clear paste, 60 ℃ of drying under reduced pressure promptly get the Rhizoma Arisaematis extract.
The method for preparing of Chinese medicine compound gel of the present invention is: carbopol 940 is added 40 times the abundant swelling of distilled water, add Radix Aconiti extract, the Rhizoma Arisaematis extract, Camphora, Moschus, glycerol, EDTA-Na respectively by said ratio
2, propylene glycol and triethanolamine, adding distil water stirs to 100g, gel.
Embodiment 2
The Chinese medicine compound gel of preparation treatment osteoarthritis.
The prescription of Chinese medicine compound gel of the present invention and proportioning:
Radix Aconiti preparation method of extract: the Radix Aconiti pulverizing medicinal materials is become coarse powder, adopt 70% acidic ethanol (pH=3) percolation to extract, collects 8 times and measure percolates, with the percolate decompression recycling ethanol; Water-bath is concentrated into relative density 1.06 (60 ℃ of heat are surveyed), filters, and filtrates with ammonia adjust pH 9 chloroform extraction 5 times; To the inanimate object alkali reaction, combining extraction liquid reclaims chloroform; Get clear paste, 60 ℃ of drying under reduced pressure promptly get the Radix Aconiti extract.
The method for preparing of the Rhizoma Arisaematis extract: with the Rhizoma Arisaematis pulverizing medicinal materials, adopt 70% acidic ethanol (pH=3) percolation to extract, collect 10 times of amount percolates, with the percolate decompression recycling ethanol; Water-bath is concentrated into relative density 1.06 (60 ℃ of heat are surveyed), and adjust pH 2 filters, and filtrating is with ammonia adjust pH 9; Chloroform extraction 5 times, to the inanimate object alkali reaction, combining extraction liquid reclaims chloroform; Get clear paste, 60 ℃ of drying under reduced pressure promptly get the Rhizoma Arisaematis extract.
The method for preparing of Chinese medicine compound gel of the present invention is: hypromellose is added 50 times the abundant swelling of distilled water; Add Radix Aconiti extract, the Rhizoma Arisaematis extract, Camphora, Moschus, glycerol, azone, propylene glycol, ethyl hydroxybenzoate respectively by said ratio; Adding distil water is to 100g; Stir, gel.
Embodiment 3
The Chinese medicine compound gel of preparation treatment osteoarthritis.
The prescription of Chinese medicine compound gel of the present invention and proportioning:
Radix Aconiti preparation method of extract: the Radix Aconiti pulverizing medicinal materials is become coarse powder, adopt 70% acidic ethanol (pH=3) percolation to extract, collects 8 times and measure percolates, with the percolate decompression recycling ethanol; Water-bath is concentrated into relative density 1.07 (60 ℃ of heat are surveyed), filters, and filtrates with ammonia adjust pH 10 chloroform extraction 5 times; To the inanimate object alkali reaction, combining extraction liquid reclaims chloroform; Get clear paste, 60 ℃ of drying under reduced pressure promptly get the Radix Aconiti extract.
The method for preparing of the Rhizoma Arisaematis extract: with the Rhizoma Arisaematis pulverizing medicinal materials, adopt 70% acidic ethanol (pH=3) percolation to extract, collect 10 times of amount percolates, with the percolate decompression recycling ethanol; Water-bath is concentrated into relative density 1.07 (60 ℃ of heat are surveyed), and adjust pH 3 filters, and filtrating is with ammonia adjust pH 10; Chloroform extraction 5 times, to the inanimate object alkali reaction, combining extraction liquid reclaims chloroform; Get clear paste, 60 ℃ of drying under reduced pressure promptly get the Rhizoma Arisaematis extract.
The method for preparing of Chinese medicine compound gel of the present invention is: polyvinylpyrrolidone is added 50 times the abundant swelling of distilled water; Add Radix Aconiti extract, the Rhizoma Arisaematis extract, Camphora, Moschus, glycerol, benzalkonium bromide respectively by said ratio; Adding distil water is to 100g; Stir, gel.
Embodiment 4
The Chinese medicine compound gel of preparation treatment osteoarthritis.
The prescription of Chinese medicine compound gel of the present invention and proportioning:
Radix Aconiti preparation method of extract: the Radix Aconiti pulverizing medicinal materials is become coarse powder, adopt 70% acidic ethanol (pH=3) percolation to extract, collects 8 times and measure percolates, with the percolate decompression recycling ethanol; Water-bath is concentrated into relative density 1.07 (60 ℃ of heat are surveyed), filters, and filtrates with ammonia adjust pH 9 chloroform extraction 5 times; To the inanimate object alkali reaction, combining extraction liquid reclaims chloroform; Get clear paste, 60 ℃ of drying under reduced pressure promptly get the Radix Aconiti extract.
The method for preparing of the Rhizoma Arisaematis extract: with the Rhizoma Arisaematis pulverizing medicinal materials, adopt 70% acidic ethanol (pH=3) percolation to extract, collect 10 times of amount percolates, with the percolate decompression recycling ethanol; Water-bath is concentrated into relative density 1.05 (60 ℃ of heat are surveyed), and adjust pH 3 filters, and filtrating is with ammonia adjust pH 9; Chloroform extraction 5 times, to the inanimate object alkali reaction, combining extraction liquid reclaims chloroform; Get clear paste, 60 ℃ of drying under reduced pressure promptly get the Rhizoma Arisaematis extract.
The method for preparing of Chinese medicine compound gel of the present invention is: carbopol 980 is added 40 times the abundant swelling of distilled water; Add Radix Aconiti extract, the Rhizoma Arisaematis extract, Camphora, Moschus, glycerol, benzalkonium bromide respectively by said ratio; Adding distil water stirs to 100g, gel.
Embodiment 5
The Chinese medicine compound gel of preparation treatment osteoarthritis.
The prescription of Chinese medicine compound gel of the present invention and proportioning:
Radix Aconiti preparation method of extract: the Radix Aconiti pulverizing medicinal materials is become coarse powder, adopt 70% acidic ethanol (pH=3) percolation to extract, collects 8 times and measure percolates, with the percolate decompression recycling ethanol; Water-bath is concentrated into relative density 1.07 (60 ℃ of heat are surveyed), filters, and filtrates with ammonia adjust pH 9 chloroform extraction 5 times; To the inanimate object alkali reaction, combining extraction liquid reclaims chloroform; Get clear paste, 60 ℃ of drying under reduced pressure promptly get the Radix Aconiti extract.
The method for preparing of the Rhizoma Arisaematis extract: with the Rhizoma Arisaematis pulverizing medicinal materials, adopt 70% acidic ethanol (pH=3) percolation to extract, collect 10 times of amount percolates, with the percolate decompression recycling ethanol; Water-bath is concentrated into relative density 1.05 (60 ℃ of heat are surveyed), and adjust pH 2 filters, and filtrating is with ammonia adjust pH 10; Chloroform extraction 5 times, to the inanimate object alkali reaction, combining extraction liquid reclaims chloroform; Get clear paste, 60 ℃ of drying under reduced pressure promptly get the Rhizoma Arisaematis extract.
The method for preparing of Chinese medicine compound gel of the present invention is: Carboxymethyl cellulose sodium is added 50 times the abundant swelling of distilled water; Add Radix Aconiti extract, the Rhizoma Arisaematis extract, Camphora, Moschus, glycerol, benzalkonium bromide respectively by said ratio; Adding distil water is to 100g; Stir, gel.
Embodiment 6
The Chinese medicine compound gel of preparation treatment osteoarthritis.
The prescription of Chinese medicine compound gel of the present invention and proportioning:
Radix Aconiti preparation method of extract: the Radix Aconiti pulverizing medicinal materials is become coarse powder, adopt 70% acidic ethanol (pH=3) percolation to extract, collects 8 times and measure percolates, with the percolate decompression recycling ethanol; Water-bath is concentrated into relative density 1.05 (60 ℃ of heat are surveyed), filters, and filtrates with ammonia adjust pH 9 chloroform extraction 5 times; To the inanimate object alkali reaction, combining extraction liquid reclaims chloroform; Get clear paste, 60 ℃ of drying under reduced pressure promptly get the Radix Aconiti extract.
The method for preparing of the Rhizoma Arisaematis extract: with the Rhizoma Arisaematis pulverizing medicinal materials, adopt 70% acidic ethanol (pH=3) percolation to extract, collect 10 times of amount percolates, with the percolate decompression recycling ethanol; Water-bath is concentrated into relative density 1.05 (60 ℃ of heat are surveyed), and adjust pH 3 filters, and filtrating is with ammonia adjust pH 10; Chloroform extraction 5 times, to the inanimate object alkali reaction, combining extraction liquid reclaims chloroform; Get clear paste, 60 ℃ of drying under reduced pressure promptly get the Rhizoma Arisaematis extract.
The method for preparing of Chinese medicine compound gel of the present invention is: hydroxypropyl cellulose is added 60 times the abundant swelling of distilled water; Add Radix Aconiti extract, the Rhizoma Arisaematis extract, Camphora, Moschus, glycerol, benzalkonium bromide respectively by said ratio; Adding distil water is to 100g; Stir, gel.
Embodiment 7
Animal experiment: the toxic and side effects of Chinese medicine compound gel of the present invention.
Be divided into two groups at random before the medication of test white mice, two groups of equal no difference of science of statistics between body weight, male and female, activity, diet and hair color.
Experimental group: 10 of white mice, male and female dual-purpose, body weight 120-124g.By the gel percutaneous drug delivery that embodiment 1 makes, twice, one time on the one 6-9g.Observe white mice food, activity and fur situation, observed continuously 15 days.
Matched group: 10 of white mice, male and female dual-purpose, body weight 119-122g.Observe white mice food, activity and fur situation, observed continuously 15 days.
Conclusion: the experimental group result is no abnormal, and the matched group result is no abnormal.Chinese medicine compound gel of the present invention has no side effect.
Embodiment 8
Pharmacological evaluation: the pharmacological effect of Chinese medicine compound gel of the present invention.
1. laboratory animal
Wistar kind rat, male and female dual-purpose, 200 ± 20g; Kunming mouse, male and female dual-purpose, 20 ± 2g, rabbit, male and female dual-purpose, 2.0-2.5kg.
2. experimental drug
Chinese medicine compound gel (making) by embodiment 2, contrast medicine: diclofenac gel
3. Chinese medicine compound gel analgesic activity experimentation
3.1 the Chinese medicine compound gel causes the analgesic activity of pain mice to hot plate method
Get female mice; Put into 55 ± 0.5 ℃ of hot plate water-baths; Licking metapedes as the pain reaction index, prediction mice pain threshold with＞5s,＜30s is shown qualified mice, 50 mices that the threshold of pain is qualified are divided into 5 groups at random; The 1st group is isodose vehicle control group, and dosage is 0.0414g excipient/20g body weight (2.07g excipient/kg); The 2nd group of positive contrast medicine diclofenac gel plaster; The 3rd group is the heavy dose of group of Chinese medicine compound gel, and dosage is 0.124g crude drug/20g body weight (6.21g crude drug/kg); The 4th group is dose groups in the Chinese medicine compound gel, and dosage is 0.0828g crude drug/20g body weight (4.14g crude drug/kg).The 5th group is Chinese medicine compound gel small dose group, and dosage is 0.0414g crude drug/20g body weight (2.07g crude drug/kg).Medicine is applied to mouse tail, administration every day 2 times, successive administration 7 days, 0.5h after the last administration, 1h, 1.5h measure pain threshold respectively, and the result sees table 1.
Table 1 Chinese medicine compound gel causes analgesic activity (n=10, the X ± SD) of mice to hot plate method
| Group | Pain threshold before the medicine | 0.5h pain threshold | The 1h pain threshold | 1.5h pain threshold |
| Vehicle group | 22.9±4.5 | 23.6±6.8 | 23.2±8.1 | 20.8±4.1 |
| Diclofenac gel group | 22.3±4.7 | 33.2±8.2 * | 28.1±9.6 | 29.7±11.2 |
| Heavy dose of group | 22.8±5.4 | 39.5±15.2 * | 34.2±15.1 | 37.4±14.3 * |
| Middle dose groups | 23.3±3.6 | 44.2±14.2 ** | 35.4±17.6 | 41.2±14.0 ** |
| Small dose group | 23.2±4.3 | 24.5±11.3 | 28.4±10.9 | 32.7±15.7 |
Annotate: compare * P＜0.05, * * P＜0.01 with vehicle group
The result shows: the big or middle dose groups of Chinese medicine compound gel can significantly improve the mice pain threshold, has significant analgesia role.
3.2 Chinese medicine compound gel Dichlorodiphenyl Acetate causes the analgesic activity of pain mice
Get 50 of body weight 18-22g healthy mices, male and female half and half are divided into 5 groups at random, divide into groups and dosage with under 3.1.Medicine is applied to mouse tail, administration every day 2 times, successive administration 7 days; In the 7th day lumbar injection 0.6% acetic acid 0.2ml/10g; Use manual time-keeping simultaneously, write down that the time (being incubation period) of the 1st writhing response appears in each Mus and in 10 minutes each Mus turn round the body number of times, the result sees table 2.
Medicine analgesia percentage rate=(matched group is turned round body number of times-administration group and turned round the body number of times)/matched group is turned round the body number of times
Table 2 Chinese medicine compound gel Dichlorodiphenyl Acetate cause the pain mice analgesic activity (n=10X ± SD):
| Group | Incubation period (min) | Turn round the body number of times | Analgesia rate (%) |
| Vehicle group | 3.57±1.40 | 31.9±9.0 | |
| Diclofenac gel group | 7.53±2.03** | 17.0±11.8* | 46.7 |
| Heavy dose of group | 6.19±2.80* | 17.3±11.18* | 45.8 |
| Middle dose groups | 7.15±2.78** | 13.5±6.9** | 57.7 |
| Small dose group | 6.91±3.53* | 14.8±6.8** | 53.6 |
Annotate: compare * P＜0.05, * * P＜0.01 with vehicle group
The result shows: the large, medium and small dose groups of Chinese medicine compound gel all can prolong mice analgesia incubation period, and can reduce mice turn round the body number of times, explain that the Chinese medicine compound gel has significant analgesia role.
4. antiinflammatory action experimentation
4.1 the Chinese medicine compound gel is to the inhibitory action of mice ear
Get 50 of body weight 25-28g male and healthy mices, divide into groups and dosage with under the 1.3.1 item, successive administration 7 days; The 8th day every mouse right ear only is coated with xylene 0.05ml/ uniformly, cause scorching 15min after, mice is taken off cervical vertebra puts to death; Card punch with diameter 8mm sweeps away left and right sides auricle, after weighing on the electronic balance, calculates the ear swelling rate respectively.The result sees table 3.
Table 3 Chinese medicine compound gel is to the influence of the mice auricle swelling (n=10 of X ± SD)
| Group | Number of animals (only) | Ear swelling rate (%) |
| Vehicle group | 10 | 103.2±41.1 |
| Diclofenac gel group | 10 | 50.2±26.8* |
| Heavy dose of group | 10 | 57.5±22.8 |
| Middle dose groups | 10 | 46.7±23.4* |
| Small dose group | 10 | 78.6±34.2 |
Annotate: compare * P＜0.05 with vehicle group
The result shows that the Chinese medicine compound gel can obviously suppress mice by the mice auricle swelling that is caused by xylene.
4.2 the Chinese medicine compound gel is to the bullate influence of rat granuloma
Get 40 of male Wistar kind rats, body weight 150 ± 20g is divided into 5 groups at random.Grouping and dosage are seen under 3.1.The ether light anaesthesia; After the right knee of each Mus is with iodine disinfection; Cut the osculum of 1cm length, with the ophthalmology tweezers that the sterilization cotton balls (adding penicillin and mixed liquor of gentamicin 0.1ml and oven dry) of the dry 10mg that weighs is subcutaneous from little otch implantation, wrap with sterile gauze immediately.With the rat back depilation, the depilation area is 4cm behind the 24h
2, beginning administration in the depilation district.Every day 2 times, successive administration 7 days, in the 8th day with sacrifice of animal, open former otch, cotton balls is taken out together with connective tissue on every side, reject fatty tissue, put in the baking oven oven dry and weigh.With claim weight deduct the weight that the former weight of cotton balls promptly gets granuloma, the result sees table 4.
Table 4 Chinese medicine compound gel is to the bullate influence of rat granuloma (X ± SD)
| Group | Number of animals (only) | Granulation dry weight (mg) |
| Vehicle group | 8 | 30.7±5.4 |
| Diclofenac gel group | 8 | 22.4±5.0** |
| Heavy dose of group | 8 | 20.9±5.8** |
| Middle dose groups | 8 | 21.7±5.3** |
| Small dose group | 8 | 23.0±6.7* |
Annotate: compare * P＜0.05, * * P＜0.01 with vehicle group
The result shows that the large, medium and small dose groups of Chinese medicine compound gel all has the obvious suppression effect to granuloma induced by implantation of cotton pellets.
Pharmacodynamic study shows that the Chinese medicine compound gel has tangible antiinflammatory, analgesic activity, and with positive control drug diclofenac gel plaster therapeutic equivalence, most of indexs are superior to the diclofenac gel, have shown this medicine excellent development application prospect.
Embodiment 9
The clinical observation of Chinese medicine compound gel treatment osteoarthritis of the present invention.
1. physical data
Patient's 100 examples, male 18 examples, women 82 examples, age 23-51 year.
Wherein, hyperosteogeny 35 examples, intervertebral disk hernia 34 examples, cervical spondylosis 21 examples, lumbar spondylosis 10 examples.
Inclusion criteria: (1) agents area does not have history of operation; (2) agents area does not have skin injury, no dermatosis; (3) agents area does not have suppurative arthritis; (4) the medication zone does not have infection.
Exclusion standard: there is the operation medical history (1) part; (2) the medication part suffers from primary bone tumor or metastatic tumor of bone; (3) agents area has skin injury or dermatosis; (4) there are osteoclasia or space occupying lesion in the part; (5) pain is with the not good or long-term oral analgesic patient of strong effect pain relieving drug effect; (6) to this medicine skin allergy patient.
2. diagnostic criteria
The osteoarthritis criteria for classification of relevant knee joint, hands and the hip joint of nineteen ninety-five Americanism damp disease association revision:
The diagnostic criteria of kneecap arthrosis: satisfy following 1+2+3+4 bar, or 1+2+5 bar or 1+4+5 person, diagnosable is the kneecap arthrosis.
(1) preceding 1 month most of time has gonalgia;
(2) the bone sound is arranged during joint motion;
(3) morning, deadlock was less than 30 minutes;
(4) age was more than or equal to 38 years old;
(5) the knee joint inspection has bone property loose.
The diagnostic criteria of hands osteoarthritis: satisfy following 1+2+3+4. bar or 1+2+3+5 bar, diagnosable is the hands osteoarthritis.Annotate: specify the joint to contain bilateral the 2nd, 3 distal interphalangeal joint of finger and PIP and the 1st carpometacarpal joints for 10.
(1) preceding 1 month most of time has pain in hand, turns sour, sends out deadlock;
Rigid tissue hypertrophy more than 2 in (2) 10 appointment joints of hand;
(3) metacarpophalangeal joints swelling less than, 2;
(4) the rigid tissue hypertrophy of DIPJ is more than 1;
Specify for (5) 10 deformity more than 1 or 1 is arranged in the joint.
The arthropathic diagnostic criteria of hipbone: satisfy following 1+2+4 bar or 1+2+5 bar, or 1+3+6+7 bar person, diagnosable hipbone arthrosis.
(1) preceding 1 month most of time has pain of bone marrow;
(2) the hip inward turning is less than 15 degree;
(3) the hip inward turning is greater than 15 degree;
(4) erythrocyte sedimentation rate is less than 45 millimeters/hour;
(5) marrow deadlock in morning was less than 60 minutes;
(6) erythrocyte sedimentation rate do not do, the hip flexing less than 115 the degree;
(7) age was greater than 50 years old;
3. Therapeutic Method
By the gel percutaneous drug delivery that embodiment 1 makes, 6-9g is embrocated in the affected part twice, one time on the one.15 days courses of treatment, 2 courses of treatment of logotype.Inspection recurrence situation after six months.
4. efficacy assessment standard
Produce effects: osteoarthrosis does not have pain, does not have tenderness around the joint, and the joint does not have swelling, 130 ° of range of motion, and X ray examination joint is normal.
Take a turn for the better: osteoarthrosis is pain slightly, light tenderness around the joint, and the joint is swelling slightly, 130 ° of range of motion, the slightly fuzzy hypertrophy in X ray examination joint space.
Invalid: tenderness, swelling around the bone joint pain, joint, range of motion is less than 130 °, and X ray examination joint space narrows down.All sign the treatment letter of consent before the treatment, obtain the approval of local Ethics Committee.
5. therapeutic effect
Treat the observation of curative effect after 15 days and 30 days, see table 1.
The observation of curative effect of table 1 treatment after 15 days and 30 days
Recurrence situation after six months: the patient of produce effects and improvement was recurred 2 people, relapse rate 2.1% after six months.
Conclusion: this gel is evident in efficacy in this group patient, and obvious antiinflammatory, analgesia, detumescence effect are arranged, and obviously improves patients ' life quality, for clinical a kind of newtype drug is provided, and the good application development prospect is arranged.
Claims (9)
1. a Chinese medicine compound gel of treating osteoarthritis is characterized in that being processed by medicine, polymer-based material, antiseptic, wetting agent and solvent, and medicine comprises Radix Aconiti extract, the Rhizoma Arisaematis extract, Camphora, Moschus moschiferous perfume; Polymer-based material is selected from any in carbopol, sodium carboxymethyl cellulose, hypromellose, hydroxypropyl cellulose, the polyvinylpyrrolidone; Antiseptic is selected from ethyl hydroxybenzoate, benzalkonium bromide, EDTA-Na
2In any;
Each components contents is in every 100g gel: Radix Aconiti extract 1-3g, Rhizoma Arisaematis extract 0.5-1.5g, Camphora 0.05-0.2g; Moschus 0.02-0.08g, polymer-based material 0.1-5g, antiseptic 0.01-0.5g; Wetting agent 5-15ml, all the other are solvent.
2. a kind of Chinese medicine compound gel of treating osteoarthritis according to claim 1 is characterized in that each components contents is in every 100g gel: Radix Aconiti extract 1.5g; Rhizoma Arisaematis extract 1g, Camphora 0.1g, Moschus 0.04g; Polymer-based material 0.1-5g, antiseptic 0.01-0.5g, wetting agent 5-15ml; All the other are solvent, and wetting agent is a glycerol, and solvent is a distilled water.
3. a kind of Chinese medicine compound gel of treating osteoarthritis according to claim 1; It is characterized in that polymer-based material is a carbopol, must add nertralizer; Nertralizer is selected from sodium hydroxide or triethanolamine, and the nertralizer consumption is 0.04-6% of a gel weight.
4. a kind of Chinese medicine compound gel of treating osteoarthritis according to claim 1; It is characterized in that; Also contain penetration enhancer in the polymer-based material; Penetration enhancer is selected from azone, limonene, propylene glycol, can select 1-2 kind chemical compound wherein simultaneously for use, and the penetration enhancer consumption is 0.5-20% of a gel weight.
5. a kind of Chinese medicine compound gel of treating osteoarthritis according to claim 3; It is characterized in that; Also contain penetration enhancer in the polymer-based material; Penetration enhancer is selected from azone, limonene, propylene glycol, can select 1-2 kind chemical compound wherein simultaneously for use, and the penetration enhancer consumption is 0.5-20% of a gel weight.
6. a kind of Chinese medicine compound gel of treating osteoarthritis according to claim 5; It is characterized in that; Each components contents is in every 100g gel: Radix Aconiti extract 1.5g; Rhizoma Arisaematis extract 1g, Camphora 0.1g, Moschus 0.04g, carbopol 1g, propylene glycol 10ml, triethanolamine 1.5g, EDTA-Na
20.05g, wetting agent 5ml, all the other are solvent.
7. a kind of method for preparing of treating the Chinese medicine compound gel of osteoarthritis according to claim 1 is characterized in that method for preparing may further comprise the steps: earlier polymer-based material is added water-soluble expanding; Radix Aconiti extract, the Rhizoma Arisaematis extract, Camphora are with 70% dissolve with ethanol; Moschus adds medicine, antiseptic, wetting agent respectively by proportioning again with ether dissolution, and solubilizer is to ormal weight; Stir, gel.
8. a kind of Chinese medicine compound gel of treating osteoarthritis according to claim 7 is characterized in that wherein the Radix Aconiti preparation method of extract is: the Radix Aconiti pulverizing medicinal materials is become coarse powder, adopt the 70% acidic ethanol percolation of pH=3 to extract; Collect 8 times of amount percolates, with the percolate decompression recycling ethanol, water-bath is concentrated into relative density 1.05～1.07, and wherein relative density is surveyed 60 ℃ of heat; Filter, filtrate with ammonia adjust pH 9～10 chloroform extraction 5 times; To the inanimate object alkali reaction, combining extraction liquid reclaims chloroform; Get clear paste, 60 ℃ of drying under reduced pressure promptly get the Radix Aconiti extract.
9. a kind of Chinese medicine compound gel of treating osteoarthritis according to claim 7 is characterized in that wherein the method for preparing of the Rhizoma Arisaematis extract is: with the Rhizoma Arisaematis pulverizing medicinal materials, adopt the 70% acidic ethanol percolation of pH=3 to extract; Collect 10 times of amount percolates, with the percolate decompression recycling ethanol, water-bath is concentrated into relative density 1.05～1.07, and wherein relative density is surveyed 60 ℃ of heat; Adjust pH 2～3 filters, and filtrates with ammonia adjust pH 9～10 chloroform extraction 5 times; To the inanimate object alkali reaction, combining extraction liquid reclaims chloroform; Get clear paste, 60 ℃ of drying under reduced pressure promptly get the Rhizoma Arisaematis extract.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2012100460699A CN102579726A (en) | 2012-02-27 | 2012-02-27 | Chinese medicinal compound gel for treating osteoarthrosis and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2012100460699A CN102579726A (en) | 2012-02-27 | 2012-02-27 | Chinese medicinal compound gel for treating osteoarthrosis and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN102579726A true CN102579726A (en) | 2012-07-18 |
Family
ID=46469328
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2012100460699A Pending CN102579726A (en) | 2012-02-27 | 2012-02-27 | Chinese medicinal compound gel for treating osteoarthrosis and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN102579726A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103611133A (en) * | 2013-11-29 | 2014-03-05 | 安徽安科余良卿药业有限公司 | Blood circulation promotion and pain alleviation gel and preparation method thereof |
| CN109364168A (en) * | 2018-12-05 | 2019-02-22 | 重庆市中医院 | A kind of cold dispelling resolving sputum dissipates and preparation method thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1557418A (en) * | 2004-02-10 | 2004-12-29 | 清 顾 | Composite Chinese medicine gelling agent for treating osteo arthropathy and preparing method thereof |
| CN101314022A (en) * | 2008-06-25 | 2008-12-03 | 邓中南 | Externally used drug for treating bone joint diseases and preparation method thereof |
| CN101554427A (en) * | 2008-04-08 | 2009-10-14 | 中国人民解放军第二军医大学 | Traditional Chinese medicine compound gel for treating osteoporosis and preparation method thereof |
-
2012
- 2012-02-27 CN CN2012100460699A patent/CN102579726A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1557418A (en) * | 2004-02-10 | 2004-12-29 | 清 顾 | Composite Chinese medicine gelling agent for treating osteo arthropathy and preparing method thereof |
| CN101554427A (en) * | 2008-04-08 | 2009-10-14 | 中国人民解放军第二军医大学 | Traditional Chinese medicine compound gel for treating osteoporosis and preparation method thereof |
| CN101314022A (en) * | 2008-06-25 | 2008-12-03 | 邓中南 | Externally used drug for treating bone joint diseases and preparation method thereof |
Non-Patent Citations (2)
| Title |
|---|
| 刘向前编著: "《骨伤科常用中药的配伍运用》", 31 January 2007, article "洋金花", pages: 429-430 * |
| 张虹等: "《洛阳正骨传统用药精粹》", 31 July 2011, article "天南星善止骨痛", pages: 71-72 * |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103611133A (en) * | 2013-11-29 | 2014-03-05 | 安徽安科余良卿药业有限公司 | Blood circulation promotion and pain alleviation gel and preparation method thereof |
| CN103611133B (en) * | 2013-11-29 | 2016-01-27 | 安徽安科余良卿药业有限公司 | Promoting blood circulation and stopping pain gel and preparation method thereof |
| CN109364168A (en) * | 2018-12-05 | 2019-02-22 | 重庆市中医院 | A kind of cold dispelling resolving sputum dissipates and preparation method thereof |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN102068474B (en) | Capparis spinosa fruit gel ointment, production method thereof, and application thereof to antirheumatic medicaments | |
| CN104474076A (en) | Traditional Chinese medicine composition for treating eczema | |
| CN104013878B (en) | A kind of lavipeditum medicine vinegar and preparation method thereof for treating tinea pedis | |
| CN110898186A (en) | Humulus scandens dissolved granules capable of clearing heat and removing toxicity | |
| CN102579726A (en) | Chinese medicinal compound gel for treating osteoarthrosis and preparation method thereof | |
| CN103330794A (en) | Unguent for treating rheumatic arthritis and preparation method thereof | |
| CN103142959A (en) | Medicament for treating urticaria | |
| CN103784541A (en) | Traditional Chinese medicine for treating pains on neck, shoulders, waist and legs | |
| CN104000863A (en) | Medicinal composition for treating malignant tumor accompanied with gall-stone and preparation method and medical application thereof | |
| CN104042765A (en) | Medicine for promoting postoperative fracture recovery and preparation method of medicine | |
| CN109045112B (en) | Wall-broken ultrafine powder decoction pieces and production method and application thereof | |
| CN103768454B (en) | A kind of composition with prevention and treatment HIV/AIDS and preparation method thereof | |
| CN106177508A (en) | The Chinese medicine external ointment for the treatment of radioactive skin injury | |
| CN102302717B (en) | Traditional Chinese medicine composition and medical pad for treating prostatic disease, and preparation method of medical pad | |
| CN105343847A (en) | Traditional Chinese medicine composition for treating eczema containing folium artemisiae argyi and preparing method thereof | |
| CN108619344A (en) | Treat the externally applied drug and preparation method thereof of gout | |
| CN103623020A (en) | Traditional Kazakh pharmaceutical composition for treating leucoderma and preparation method of traditional Kazakh pharmaceutical composition | |
| CN107582776A (en) | One kind treats nettle rash purslane dip and preparation method thereof | |
| CN114028483B (en) | Pharmaceutical composition and preparation for treating chronic soft tissue injury | |
| CN103893436B (en) | A kind of externally applied drug for treating rheumatism | |
| CN113663049B (en) | Li nationality medicine postpartum medicated bath effervescent granules and preparation method thereof | |
| CN102727834B (en) | Traditional Chinese medicine composition for treating migraine, and preparation method and application thereof | |
| CN105326899A (en) | Traditional Chinese medicine for treating leukoderma and preparation method for traditional Chinese medicine | |
| CN102078483B (en) | Chinese patent medicine (Bezoar Qianliekang Turunda) for treating prostate disease and preparation method thereof | |
| CN101099781B (en) | External-applied traditional Chinese medicine for treating middle and late brain tumor |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| RJ01 | Rejection of invention patent application after publication |
Application publication date: 20120718 |