A kind of Chinese medicine composition for the treatment of periodontitis and preparation method thereof
Technical field
The present invention relates to a kind of Chinese medicine composition for the treatment of periodontitis and preparation method thereof, belong to the field of Chinese medicines.
Background technology
Periodontitis is one of modal oral pathology, is a kind of chronic infectious disease of invading gingiva, periodontal ligament and alveolar bone.With gingival swelling and pain, easily hemorrhage, periodontal pocket forms feature, periodontitis often causes patient's odontoseisis to come off, forfeiture masticatory function and have a strong impact on physical and mental health.Data shows: the sickness rate of periodontitis is up to 50%-60% among China adult.And that the danger of heart infarction takes place in the heart patient who suffers from periodontitis is higher 2~3 times than the heart patient of no periodontitis.Periodontitis and oral cavity bacterium also can cause bacterial pneumonia, and annual therefore nearly 8.3 ten thousand people are devitalized in the whole world.Because most of people are not enough to the seriousness of periodontal disease understanding, therefore, sickness rate that in recent years should disease continues to rise.Cultivate along with anaerobism behind the seventies and the progress of isolation technics, more and more evidences show that anaerobe is the dominant bacteria in the many infected specimens in oral cavity, comprising many gram negative bacterias, all can discharge endotoxin, having the various biological activity, is potential pro-inflammatory cytokine in the oral cavity.Bacillus fragilis is that clinical each section comprises most important pathogen in the department of stomatology anaerobic infection, and deep, oral cavity pus infections is normal relevant with fusiform bacilarmature.
The Chinese medicine periodontitis has a long history, and has accumulated the experience enriched, and forms complete theoretical system, has the incomparable advantage of Western medicine in some aspects.Periodontitis belongs to traditional Chinese medical science gingival atrophy category, though the traditional Chinese medical science is thought its diseased region at tooth and gum, its pathological change and gastric heat are processed and filled substantial connection, if eating and drinking without temperance or oral cavity are unclean at ordinary times, all can amass heat in stomach, gastric heat is followed through last inflammation, can cause the outbreak of primary disease, so control suitable eliminating stomach-fire.
Summary of the invention
Problem to be solved by this invention provide a kind ofly have storage, carry, taking convenience, curative effect height, Chinese medicine composition of the treatment periodontitis that dose is little, toxic and side effects is low and preparation method thereof.
Technical scheme provided by the invention is: a kind of Chinese medicine composition for the treatment of periodontitis, the method of pressing makes: with the Rhizoma Coptidis of 10~20wt%, the Rhizoma Cimicifugae of 20~35wt%, the Gypsum Fibrosum of 20~35t%, the Radix Angelicae Sinensis of 2~12wt%, the Radix Rehmanniae of 2~12wt%, the Cortex Moutan of 8~16wt% is the feedstock production fine powder, by fine powder: the weight proportion of adjuvant=1: 0.4~0.6 adds adjuvant in the fine powder, granulate, dry, sieve, promptly get Chinese medicine composition; Fine powder prepares as follows: Rhizoma Coptidis is used alcohol reflux, filters, and merging filtrate reclaims ethanol, concentrate extractum I; Cortex Moutan adopts hydrodistillation extraction volatile material altogether, filters, and gets filtrate I, and medicinal residues and surplus medicine Radix Rehmanniae, Radix Angelicae Sinensis, Gypsum Fibrosum and Rhizoma Cimicifugae decoct with water extraction, filter, filtrate II, merging filtrate I, II, concentrate extractum II, merge extractum I, II, be concentrated into thick paste, drying gets dry extract; Dry extract is broken into fine powder promptly.
The consumption of the raw material of above-mentioned preparation fine powder is preferably: the Gypsum Fibrosum of the Rhizoma Coptidis of 12~18wt%, the Rhizoma Cimicifugae of 25~30wt%, 25~30wt%, the Radix Angelicae Sinensis of 6~10wt%, the Radix Rehmanniae of 6~10wt%, the Cortex Moutan of 10~15wt%.
The present invention also provides the preparation method of above-mentioned Chinese medicine composition: Rhizoma Coptidis is used alcohol reflux, filters, and merging filtrate reclaims ethanol, concentrate extractum I; Cortex Moutan adopts hydrodistillation extraction volatile material altogether, filters, and gets filtrate I, and medicinal residues and surplus medicine Radix Rehmanniae, Radix Angelicae Sinensis, Gypsum Fibrosum and Rhizoma Cimicifugae decoct with water extraction, filter, filtrate II, merging filtrate I, II, concentrate extractum II, merge extractum I, II, be concentrated into thick paste, drying gets dry extract; Dry extract is broken into fine powder, presses fine powder: the weight proportion of adjuvant=1: 0.4~0.6 adds adjuvant, granulates, and drying is sieved, and promptly gets required Chinese medicine composition.The Chinese medicine composition that makes can incapsulate and make capsule; Also can beat sheet and become tablet; Or pack with medicinal aluminum-plastic composite membrane.
Above-mentioned adjuvant can be selected starch or dextrin etc. for use.
It is 2~3 times that above-mentioned decocting boils number of times, and each decocting time is 1.0~1.5 hours.
The used ethanol of above-mentioned alcohol reflux is the ethanol water of 50~90% volume ratios, and extraction time is 2~3 times, and each time is 1.0~1.5 hours.
Above-mentioned Cortex Moutan extracts volatile material---paeonol with being total to hydrodistillation.
Above-mentioned granulation adopts marumerization to granulate.
The present invention has storage, carries, taking convenience, the curative effect height, and dose is little, toxic and side effects is low, and is quality controllable, and plurality of advantages such as good stability have preferably gastric emptying, antiinflammatory, rush down down, analgesia and bacteriostasis; Periodontitis had better therapeutic effect.Thereby its broad market prospect.
The pharmacodynamics of the Chinese medicine composition of treatment periodontitis of the present invention and toxicology test result of study show:
(1), main pharmacodynamics research
1, emptying test: the present invention has obvious reinforcement mice gastric emptying, and along with dosage strengthens and the effect reinforcement, with blank group ratio, significant difference (P<0.05) is arranged.
2, gastric analysis test: three dosage groups of the present invention and detoxicating tablet of cow-bezoar group, each index of rat gastric analysis all there is not obvious influence.
3, full gastrointestinal tract ahead running test: the first grain of the present invention melena time of occurrence is faster than blank group, significant difference (P<0.05).The detoxicating tablet of cow-bezoar group also has similar effect, but than the effect of the present invention group little (P<0.05).Increase with dosage, discharge function of the present invention strengthens.
4, analgesic test: Dichlorodiphenyl Acetate of the present invention is pain caused to have obvious analgesic effect.
5, antiinflammatory test: each administration group of the present invention all has the effect of certain anti-mice caused by dimethylbenzene xylene ear swelling, and with blank group ratio, 1.11g/kg, 2.22g/kg (in crude drug) dosage group has significant difference (P<0.05, P<0.01).
6, antibacterial and bactericidal action:
1.. in vitro tests shows, the present invention pair 6 kind pathogen relevant with oral cavity infection, comprising gram-positive cocci, staphylococcus aureus, staphylococcus epidermidis, beta hemolytic streptococcus, Diplococcus pneumoniae, Gram-negative does not have brood cell's anaerobe, gums bacteroid, bacteroides fragilis and has significantly antibacterial and bactericidal action.Compare with the positive control drug detoxicating tablet of cow-bezoar, both are similar to the effect of golden Portugal bacterium, staphylococcus epidermidis, gums bacteroid, bacteroides fragilis, and Diplococcus pneumoniae the present invention slightly is better than detoxicating tablet of cow-bezoar.
2.. bacteriostatic test in the body: the present invention is to inhibitory action in the tangible body of the main pathogenic bacterium of periodontitis (Fusobacterium nucleatum, actinomyces viscosus, staphylococcus aureus) tool.The present invention of doses can effectively protect the animal that is subjected to pathogenic infection.
(2) toxicological study
1, acute toxicity test: to mouse stomach administration, LD
50Be 28.92g/kg (in crude drug), be equivalent to more than 156 times of oral recommendation consumption adult's every day, mouse peritoneal (ip) administration, LD
50Be 2.608g/kg (in crude drug), be equivalent to more than 14 times of oral recommendation consumption adult's every day.
2, long term toxicity test: around rat continuous irrigation stomach, dosage is equivalent to 60,15,3 times of clinical recommendation consumption, and all in normal range, toxic reaction is not seen to every blood parameters by histopathologic examination.
In sum, the Chinese medicine composition of treatment periodontitis of the present invention can be strengthened the gastric emptying effect of animal, quickens full gastrointestinal tract ahead running, promotes to rush down down, has obvious analgesic effect.Have significantly antibacterial and bactericidal action, to causing the important pathogenic bacteria of periodontitis---anaerobe has significantly antibacterial and bactericidal action, and does not see the effect report of domestic like product to anaerobe.Toxicity test explanation toxicity of the present invention is low.
The specific embodiment
Embodiment 1:
Get Rhizoma Coptidis 100g, Rhizoma Cimicifugae 250g, Gypsum Fibrosum 250g, Radix Angelicae Sinensis 90g, Radix Rehmanniae 90g, Cortex Moutan 150g; Rhizoma Coptidis was extracted 1.5 hours with 80% alcohol reflux twice for the first time, filtered; Extracted 1.0 hours for the second time, filter.Merging filtrate, ethanol is reclaimed in decompression (70 ℃), and concentrating under reduced pressure gets extractum (I).Cortex Moutan extracts volatile material with being total to hydrodistillation, filter, get filtrate (I), four flavors such as medicinal residues and surplus medicine Radix Rehmanniae, Rhizoma Cimicifugae, Gypsum Fibrosum, Radix Angelicae Sinensis decoct with water twice, decoct 1.5 hours for the first time, filter, decocted 1.0 hours for the second time, filter, get filtrate (II), merging filtrate (I), (II), concentrating under reduced pressure (70 ℃) gets extractum (II).Merge extractum (I), (II), concentrate thick paste, drying, dry extract.Dry extract is broken into fine powder.
Fine powder mixes with 180g starch, granulates with one-step-granulating method.Wet grain is put 60 ℃ of dryings, crosses 20 mesh sieve granulate, removes fine powder with 60 mesh sieves sieve, gets granule.Incapsulate, check gets finished product.
Embodiment 2: get Rhizoma Coptidis 200g, Rhizoma Cimicifugae 200g, Gypsum Fibrosum 200g, Radix Angelicae Sinensis 70g, Radix Rehmanniae 70g, Cortex Moutan 100g; Rhizoma Coptidis was extracted 1.5 hours with 70% alcohol reflux twice for the first time, filtered; Extracted 1.0 hours for the second time, filter.Merging filtrate, ethanol is reclaimed in decompression (70 ℃), and concentrating under reduced pressure gets extractum (I).Cortex Moutan extracts volatile material with being total to hydrodistillation, filter, get filtrate (I), four flavors such as medicinal residues and surplus medicine Radix Rehmanniae, Rhizoma Cimicifugae, Gypsum Fibrosum, Radix Angelicae Sinensis decoct with water twice, decoct 1.5 hours for the first time, filter, decocted 1.0 hours for the second time, filter, get filtrate (II), merging filtrate (I), (II), concentrating under reduced pressure (70 ℃) gets extractum (II).Merge extractum (I), (II), concentrate thick paste, drying, dry extract.Dry extract is broken into fine powder.
Fine powder mixes with 200g starch, granulates with one-step-granulating method.Wet grain is put 60 ℃ of dryings, crosses 20 mesh sieve granulate, removes fine powder with 60 mesh sieves sieve, gets granule.Incapsulate, check gets finished product.
Embodiment 3: get Rhizoma Coptidis 150g, Rhizoma Cimicifugae 250g, Gypsum Fibrosum 250g, Radix Angelicae Sinensis 75g, Radix Rehmanniae 75g, Cortex Moutan 125g; Rhizoma Coptidis was extracted 1.5 hours with 65% alcohol reflux twice for the first time, filtered; Extracted 1.0 hours for the second time, filter.Merging filtrate, ethanol is reclaimed in decompression (70 ℃), and concentrating under reduced pressure gets extractum (I).Cortex Moutan extracts volatile material with being total to hydrodistillation, filter, get filtrate (I), four flavors such as medicinal residues and surplus medicine Radix Rehmanniae, Rhizoma Cimicifugae, Gypsum Fibrosum, Radix Angelicae Sinensis decoct with water twice, decoct 1.5 hours for the first time, filter, decocted 1.0 hours for the second time, filter, get filtrate (II), merging filtrate (I), (II), concentrating under reduced pressure (70 ℃) gets extractum (II).Merge extractum (I), (II), concentrate thick paste, drying, dry extract.Dry extract is broken into fine powder.
Fine powder mixes with 190g starch, granulates with one-step-granulating method.Wet grain is put 60 ℃ of dryings, crosses 20 mesh sieve granulate, removes fine powder with 60 mesh sieves sieve, gets granule.Incapsulate, check gets finished product.
Embodiment 4: get Rhizoma Coptidis 150g, Rhizoma Cimicifugae 250g, Gypsum Fibrosum 250g, Radix Angelicae Sinensis 75g, Radix Rehmanniae 75g, Cortex Moutan 125g; Rhizoma Coptidis was extracted 1.5 hours with 65% alcohol reflux twice for the first time, filtered; Extracted 1.0 hours for the second time, filter.Merging filtrate, ethanol is reclaimed in decompression (70 ℃), and concentrating under reduced pressure gets extractum (I).Cortex Moutan extracts volatile material with being total to hydrodistillation, filter, get filtrate (I), four flavors such as medicinal residues and surplus medicine Radix Rehmanniae, Rhizoma Cimicifugae, Gypsum Fibrosum, Radix Angelicae Sinensis decoct with water twice, decoct 1.5 hours for the first time, filter, decocted 1.0 hours for the second time, filter, get filtrate (II), merging filtrate (I), (II), concentrating under reduced pressure (70 ℃) gets extractum (II).Merge extractum (I), (II), concentrate thick paste, drying, dry extract.Dry extract is broken into fine powder.
Fine powder mixes with 190g starch, granulates with one-step-granulating method.Wet grain is put 60 ℃ of dryings, crosses 20 mesh sieve granulate, removes fine powder with 60 mesh sieves sieve, gets granule.Beat sheet, check gets finished product.
Embodiment 5: get Rhizoma Coptidis 150g, Rhizoma Cimicifugae 200g, Gypsum Fibrosum 200g, Radix Angelicae Sinensis 50g, Radix Rehmanniae 50g, Cortex Moutan 120g; Rhizoma Coptidis was extracted 1.5 hours with 65% alcohol reflux twice for the first time, filtered; Extracted 1.0 hours for the second time, filter.Merging filtrate, ethanol is reclaimed in decompression (70 ℃), and concentrating under reduced pressure gets extractum (I).Cortex Moutan extracts volatile material with being total to hydrodistillation, filter, get filtrate (I), four flavors such as medicinal residues and surplus medicine Radix Rehmanniae, Rhizoma Cimicifugae, Gypsum Fibrosum, Radix Angelicae Sinensis decoct with water twice, decoct 1.5 hours for the first time, filter, decocted 1.0 hours for the second time, filter, get filtrate (II), merging filtrate (I), (II), concentrating under reduced pressure (70 ℃) gets extractum (II).Merge extractum (I), (II), concentrate thick paste, drying, dry extract.Dry extract is broken into fine powder.
Fine powder mixes with 190g starch, granulates with one-step-granulating method.Wet grain is put 60 ℃ of dryings, crosses 20 mesh sieve granulate, removes fine powder with 60 mesh sieves sieve, gets granule.Granule is packed with medicinal aluminum-plastic composite membrane, and check gets finished product.