CN1263449C - Buccal tablet for treating oral anaerobe infection disease and its manufacturing method - Google Patents
Buccal tablet for treating oral anaerobe infection disease and its manufacturing method Download PDFInfo
- Publication number
- CN1263449C CN1263449C CN 200410060435 CN200410060435A CN1263449C CN 1263449 C CN1263449 C CN 1263449C CN 200410060435 CN200410060435 CN 200410060435 CN 200410060435 A CN200410060435 A CN 200410060435A CN 1263449 C CN1263449 C CN 1263449C
- Authority
- CN
- China
- Prior art keywords
- mixed
- metronidazole
- buccal tablet
- minutes
- stevioside
- 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.)
- Expired - Fee Related
Links
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 title claims abstract description 18
- 208000015181 infectious disease Diseases 0.000 title claims abstract description 12
- 238000004519 manufacturing process Methods 0.000 title claims description 11
- 229940046011 buccal tablet Drugs 0.000 title abstract 9
- 239000006189 buccal tablet Substances 0.000 title abstract 9
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims abstract description 30
- 239000003814 drug Substances 0.000 claims abstract description 24
- 239000008187 granular material Substances 0.000 claims abstract description 23
- VAOCPAMSLUNLGC-UHFFFAOYSA-N metronidazole Chemical compound CC1=NC=C([N+]([O-])=O)N1CCO VAOCPAMSLUNLGC-UHFFFAOYSA-N 0.000 claims abstract description 23
- 229960000282 metronidazole Drugs 0.000 claims abstract description 23
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims abstract description 20
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims abstract description 14
- 239000004375 Dextrin Substances 0.000 claims abstract description 14
- 229920001353 Dextrin Polymers 0.000 claims abstract description 14
- 229930195725 Mannitol Natural products 0.000 claims abstract description 14
- UEDUENGHJMELGK-HYDKPPNVSA-N Stevioside Chemical compound O([C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@H]1O[C@]12C(=C)C[C@@]3(C1)CC[C@@H]1[C@@](C)(CCC[C@]1([C@@H]3CC2)C)C(=O)O[C@H]1[C@@H]([C@@H](O)[C@H](O)[C@@H](CO)O1)O)[C@@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O UEDUENGHJMELGK-HYDKPPNVSA-N 0.000 claims abstract description 14
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims abstract description 14
- 229930006000 Sucrose Natural products 0.000 claims abstract description 14
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims abstract description 14
- 239000001768 carboxy methyl cellulose Substances 0.000 claims abstract description 14
- 235000019425 dextrin Nutrition 0.000 claims abstract description 14
- 239000000594 mannitol Substances 0.000 claims abstract description 14
- 235000010355 mannitol Nutrition 0.000 claims abstract description 14
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 claims abstract description 14
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 claims abstract description 14
- 229940013618 stevioside Drugs 0.000 claims abstract description 14
- OHHNJQXIOPOJSC-UHFFFAOYSA-N stevioside Natural products CC1(CCCC2(C)C3(C)CCC4(CC3(CCC12C)CC4=C)OC5OC(CO)C(O)C(O)C5OC6OC(CO)C(O)C(O)C6O)C(=O)OC7OC(CO)C(O)C(O)C7O OHHNJQXIOPOJSC-UHFFFAOYSA-N 0.000 claims abstract description 14
- 235000019202 steviosides Nutrition 0.000 claims abstract description 14
- 239000005720 sucrose Substances 0.000 claims abstract description 14
- NOOLISFMXDJSKH-UHFFFAOYSA-N DL-menthol Natural products CC(C)C1CCC(C)CC1O NOOLISFMXDJSKH-UHFFFAOYSA-N 0.000 claims abstract description 10
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims abstract description 10
- 235000019359 magnesium stearate Nutrition 0.000 claims abstract description 10
- 239000000080 wetting agent Substances 0.000 claims abstract description 9
- 239000000341 volatile oil Substances 0.000 claims abstract description 8
- 238000003756 stirring Methods 0.000 claims description 11
- 230000001476 alcoholic effect Effects 0.000 claims description 9
- 239000000203 mixture Substances 0.000 claims description 8
- 238000002156 mixing Methods 0.000 claims description 7
- 239000000843 powder Substances 0.000 claims description 7
- 229910001220 stainless steel Inorganic materials 0.000 claims description 7
- 239000010935 stainless steel Substances 0.000 claims description 7
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 7
- 238000001035 drying Methods 0.000 claims description 4
- 238000005453 pelletization Methods 0.000 claims description 4
- 238000010438 heat treatment Methods 0.000 claims description 3
- 238000005096 rolling process Methods 0.000 claims description 3
- 239000007921 spray Substances 0.000 claims description 3
- 206010013786 Dry skin Diseases 0.000 claims description 2
- 239000002131 composite material Substances 0.000 claims description 2
- 239000003826 tablet Substances 0.000 abstract description 17
- 201000010099 disease Diseases 0.000 abstract description 8
- 239000000686 essence Substances 0.000 abstract description 6
- 230000003115 biocidal effect Effects 0.000 abstract description 3
- 230000001225 therapeutic effect Effects 0.000 abstract description 3
- 238000002360 preparation method Methods 0.000 abstract 3
- NOOLISFMXDJSKH-UTLUCORTSA-N (+)-Neomenthol Chemical compound CC(C)[C@@H]1CC[C@@H](C)C[C@@H]1O NOOLISFMXDJSKH-UTLUCORTSA-N 0.000 abstract 2
- 238000013329 compounding Methods 0.000 abstract 2
- 239000001525 mentha piperita l. herb oil Substances 0.000 abstract 2
- 229940041616 menthol Drugs 0.000 abstract 2
- 235000019477 peppermint oil Nutrition 0.000 abstract 2
- 229960004106 citric acid Drugs 0.000 abstract 1
- 230000036449 good health Effects 0.000 abstract 1
- 239000004615 ingredient Substances 0.000 abstract 1
- 229960001855 mannitol Drugs 0.000 abstract 1
- 229960004793 sucrose Drugs 0.000 abstract 1
- 230000000694 effects Effects 0.000 description 17
- 210000000214 mouth Anatomy 0.000 description 12
- 210000003296 saliva Anatomy 0.000 description 9
- 208000007565 gingivitis Diseases 0.000 description 8
- 201000001245 periodontitis Diseases 0.000 description 8
- 239000000047 product Substances 0.000 description 7
- 238000012360 testing method Methods 0.000 description 7
- 208000009019 Pericoronitis Diseases 0.000 description 6
- 229940079593 drug Drugs 0.000 description 5
- 238000012856 packing Methods 0.000 description 5
- 208000024891 symptom Diseases 0.000 description 4
- 208000025157 Oral disease Diseases 0.000 description 3
- 230000003203 everyday effect Effects 0.000 description 3
- 208000030194 mouth disease Diseases 0.000 description 3
- 244000052769 pathogen Species 0.000 description 3
- 230000001717 pathogenic effect Effects 0.000 description 3
- HEDRZPFGACZZDS-UHFFFAOYSA-N Chloroform Chemical compound ClC(Cl)Cl HEDRZPFGACZZDS-UHFFFAOYSA-N 0.000 description 2
- 238000007599 discharging Methods 0.000 description 2
- 230000000857 drug effect Effects 0.000 description 2
- 238000002474 experimental method Methods 0.000 description 2
- 239000012467 final product Substances 0.000 description 2
- 230000002401 inhibitory effect Effects 0.000 description 2
- 230000003902 lesion Effects 0.000 description 2
- 238000000034 method Methods 0.000 description 2
- 230000000813 microbial effect Effects 0.000 description 2
- 235000010603 pastilles Nutrition 0.000 description 2
- 210000003800 pharynx Anatomy 0.000 description 2
- 238000007789 sealing Methods 0.000 description 2
- 238000003860 storage Methods 0.000 description 2
- 231100000331 toxic Toxicity 0.000 description 2
- 230000002588 toxic effect Effects 0.000 description 2
- ZCYVEMRRCGMTRW-UHFFFAOYSA-N 7553-56-2 Chemical compound [I] ZCYVEMRRCGMTRW-UHFFFAOYSA-N 0.000 description 1
- 241000193830 Bacillus <bacterium> Species 0.000 description 1
- 241000894006 Bacteria Species 0.000 description 1
- 241000606125 Bacteroides Species 0.000 description 1
- 241000606124 Bacteroides fragilis Species 0.000 description 1
- 206010006326 Breath odour Diseases 0.000 description 1
- 206010018276 Gingival bleeding Diseases 0.000 description 1
- 208000024283 Gingival haemorrhages Diseases 0.000 description 1
- 208000032139 Halitosis Diseases 0.000 description 1
- 206010020751 Hypersensitivity Diseases 0.000 description 1
- 206010052098 Iodine allergy Diseases 0.000 description 1
- 241000192035 Peptostreptococcus anaerobius Species 0.000 description 1
- 238000009825 accumulation Methods 0.000 description 1
- 208000026935 allergic disease Diseases 0.000 description 1
- 230000007815 allergy Effects 0.000 description 1
- 239000005030 aluminium foil Substances 0.000 description 1
- 238000004458 analytical method Methods 0.000 description 1
- 208000007502 anemia Diseases 0.000 description 1
- 235000019606 astringent taste Nutrition 0.000 description 1
- 230000033228 biological regulation Effects 0.000 description 1
- 150000001720 carbohydrates Chemical class 0.000 description 1
- 239000011248 coating agent Substances 0.000 description 1
- 238000000576 coating method Methods 0.000 description 1
- 235000009508 confectionery Nutrition 0.000 description 1
- 238000003745 diagnosis Methods 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 239000002389 essential drug Substances 0.000 description 1
- 238000011156 evaluation Methods 0.000 description 1
- 238000011049 filling Methods 0.000 description 1
- 210000004195 gingiva Anatomy 0.000 description 1
- 230000035876 healing Effects 0.000 description 1
- 239000003112 inhibitor Substances 0.000 description 1
- 229910052740 iodine Inorganic materials 0.000 description 1
- 239000011630 iodine Substances 0.000 description 1
- 230000000622 irritating effect Effects 0.000 description 1
- 238000011068 loading method Methods 0.000 description 1
- 231100000053 low toxicity Toxicity 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 235000012054 meals Nutrition 0.000 description 1
- 239000011812 mixed powder Substances 0.000 description 1
- 239000007935 oral tablet Substances 0.000 description 1
- 229940096978 oral tablet Drugs 0.000 description 1
- 238000004806 packaging method and process Methods 0.000 description 1
- 230000003239 periodontal effect Effects 0.000 description 1
- 230000003285 pharmacodynamic effect Effects 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- CPJJXNTZFVBYIA-UHFFFAOYSA-M potassium boric acid chloride Chemical compound [Cl-].[K+].OB(O)O CPJJXNTZFVBYIA-UHFFFAOYSA-M 0.000 description 1
- 239000003507 refrigerant Substances 0.000 description 1
- 230000004044 response Effects 0.000 description 1
- 238000005070 sampling Methods 0.000 description 1
- 230000006641 stabilisation Effects 0.000 description 1
- 238000011105 stabilization Methods 0.000 description 1
- 230000008961 swelling Effects 0.000 description 1
- 230000009885 systemic effect Effects 0.000 description 1
- 208000004371 toothache Diseases 0.000 description 1
- 231100000419 toxicity Toxicity 0.000 description 1
- 230000001988 toxicity Effects 0.000 description 1
- 238000012795 verification Methods 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The present invention relates to a buccal tablet for treating oral anaerobe infection diseases and a preparation method thereof. The buccal tablet can effectively solve the disease treatment problem caused by anaerobe. The tablet is prepared from metronidazole, sodium carboxymethylcellulose, dextrin, stevioside, mannitol, sucrose, citric acid, menthol, peppermint oil, essence, ethanol solution and magnesium stearate. The preparation method of the buccal tablet comprises the following steps: the sucrose, the mannitol, the metronidazole, the sodium carboxymethylcellulose, the dextrin and the stevioside are respectively pulverized and sieved to be evenly mixed according to the requirement of the compounding ratio; a wetting agent prepared from the ethanol solution and the citric acid is added; granules are prepared and dried; the menthol, the peppermint oil and the essence are mixed to be prepared into volatile oil, and the volatile oil is sprayed on the dry granules according to the requirement of the compounding ratio; the magnesium stearate is added into the medicament granules, the medicament granules are pressed into tablets, and the buccal tablet is obtained. The buccal tablet has the advantages that the ingredients are scientific and reasonable, a person can easily take the buccal tablet, the therapeutic effect is good, the preparation method is advanced, and the buccal tablet is an invention on the basis of the existing antibiotic medicament. The popularization and the application of the buccal tablet provide the creativity contribution for people's good health.
Description
One, technical field
The present invention relates to a kind of mouth cheek sheet and production method thereof for the treatment of oral anaerobe infection disease clinically.
Two, background technology
Anaerobic infection can cause multiple disease, as oral diseases such as periodontitis, gingivitis, pericoronitis.The essential drugs for the treatment of the anaerobic infection disease in the market have contain the metronidazole composition the fan you take off, cydiodine or other drug, oral, sticking tablet and stick etc. are arranged, though be used for the treatment of oral diseases such as periodontitis, gingivitis, pericoronitis certain curative effect is arranged, but the oral tablet amount is big, cause that systemic side effects is also big, the sticking tablet bitter in the mouth, the patient is difficult for accepting, stick can not be personal by the patient, its curative effect is also unsatisfactory, and therefore existing medicine for the treatment of the disease that causes because of anaerobic infection does not satisfy patient's needs.
Three, summary of the invention
Actual needs at above-mentioned situation and treatment disease, the present invention's purpose just provides a kind of mouth cheek sheet and production method thereof of new treatment oral anaerobe infection disease, can effectively solve the microbial disease treatment problem of anaerobism, the technical scheme of its realization is that this tablet is to be made by metronidazole, sodium carboxymethyl cellulose, dextrin, stevioside, mannitol, sucrose, citric acid, Mentholum, Oleum menthae, essence, alcoholic solution and magnesium stearate; The production method of its realization is with sucrose; mannitol; metronidazole; sodium carboxymethyl cellulose; dextrin; the stevioside pulverize separately sieves; by the ratio requirement uniform mixing together; add citric acid with alcoholic solution and become wetting agent; wetting agent is added in the mixed powder; use the granulator corning; be dried to dry granular; again by ratio requirement, with Mentholum; Oleum menthae and essence are mixed into volatile oil solution, and spray is added in the dry granular; on request magnesium stearate is added in the medicine grain that contains volatile oil again and mix; afterwards, repress is made sheet, gets final product through packing; component science of the present invention; rationally; easily take good effect, production method advanced person; be the invention greatly to existing antibiotic medicine, it is applied and will be people's the healthy creative contribution of making.
Four, the specific embodiment
Below in conjunction with concrete condition, the specific embodiment of the present invention is elaborated.
By the mouth cheek sheet of preceding described treatment oral anaerobe infection disease of the present invention be by:
Metronidazole 0.18-0.22kg sodium carboxymethyl cellulose 0.8-1.0kg dextrin 1.8-2.2kg
Stevioside 0.5-0.7kg mannitol 9-11kg sucrose 18-22kg
Citric acid 300-360g Mentholum 40-48g Oleum menthae 30-36ml
Essence 30-36ml mass concentration is that the alcoholic solution 5.5-6.5kg of 50-60% and the magnesium stearate of medicine dry granular total amount 0.8-1.2% are made, and can make the tablet of any amount by the ratio of above-mentioned quantity.Its production method is; with sucrose; mannitol; metronidazole; sodium carboxymethyl cellulose; dextrin; after stevioside is handled by the pharmacy requirement; pulverize separately sieves; by the dosage requirement with sucrose 18-22kg; mannitol 9-11kg; metronidazole 0.18-0.22kg; sodium carboxymethyl cellulose 0.8-1.0kg; dextrin 1.8-2.2kg and stevioside 0.5-0.7kg put in the mixing arrangement; mixing; standby; get mass concentration and be 95% ethanol and add entry; being mixed with mass concentration is the alcoholic solution 5.5-6.5kg of 50-60%; in solution, add citric acid 300-360g; make it fully be dissolved into wetting agent; wetting agent is added in the composite medicated powder; place in the mixer-granulator and granulate; again the wet granular that makes is put in the heated-air circulation oven; in 18-26 ℃ (room temperature) following air blast dehumidifying reheat drying after 20-30 minute; baking temperature is 70-75 ℃; regular dehumidifying; 55-65 minute stirring once; after doing the different granule mixing of wet degree; tiling evenly again; continued dry 35-45 minute; stirring once again; descended dry 2.5-3 hour at 70-75 ℃; to doing; stop heating; air blast; water content is 2-3% in the dry patent medicine grain; in time after the discharging, after loading onto 14 order stainless steel meshs and carry out granulate with quick crushing and pelletizing machine, place container; will be under the rolling situation by Mentholum 40-48g; the be mixed volatile oil mixed liquor that evenly becomes of Oleum menthae 30-36ml and essence 30-36ml sprays and is added in the dry granular; mixed 2-3 minute, and afterwards, added the magnesium stearate of dried granule gross weight 0.8-1.2%; roll and mixed 2-3 minute; place mixer again, mix homogeneously (about 30 minutes) gets final product with in blocks packing of tablet machine compacting.
To make 66000 tablets of medicines is example; its concrete production method is; with sucrose; mannitol is ground into 80 order fine powders with Universalpulverizer respectively; metronidazole; sodium carboxymethyl cellulose is crossed 100 mesh sieves respectively; dextrin; stevioside is crossed 60 mesh sieves respectively; by ratio requirement; with metronidazole 0.2kg; sodium carboxymethyl cellulose 0.9kg; stevioside 0.6kg; dextrin 2kg; mannitol 10kg; sucrose 20kg places three-dimensional motion mixer; mixed 30 minutes; with mass concentration is that to add mass concentration that pure water makes be 55% alcoholic solution for 95% ethanol; to be that the wetting agent of 55% alcoholic solution 6kg and citric acid 330g mixing melt into adds in the medicated powder of mix homogeneously in the pot by mass concentration again; place high efficient mixed granulator again; stir; cut 2-3 minute (being advisable) with 2.5 minutes; place oscillating granulator to granulate again again with 12 order stainless steel meshs; afterwards; be contained in the stainless steel disc; every dish grain thickness be no more than 3.5cm (centimetre); place heated-air circulation oven; at 25 ℃ of following air blast dehumidifying after 25 minutes; again at 70 ℃ of following heat dryings; regular dehumidifying; stirring once after 60 minutes; tiling was even again after the different granule of wet degree mixed with doing; continued dry about 40 minutes; stirring once again; dry 2.5-3 hour (be generally 3 hours the most suitable); stop heating; air blast; dry patent medicine grain water content is the dried granule of 2-3% (being advisable with 2%); the quick crushing and pelletizing machine of reuse is loaded onto 14 order stainless steel meshs and is carried out quick granulate; afterwards; with Mentholum 44g; the volatile oil mixed liquor that Oleum menthae 33ml and essence 33ml are mixed and made into is sprayed in the dried granule; mix 2-3 minute (be generally 3 minutes the most suitable); after again the magnesium stearate of 337 grams being crossed 100 mesh sieves; add in the granule in rolling; mix 2-3 minute (be generally and be advisable in 2.5 minutes); place the two dimensional motion mixer again; mixed 30 minutes; with the tablet machine compacting in flakes; every 0.5 gram includes metronidazole 3mg.In the tabletting process, heavy every 15-20 minute sampling check sheet, discharge useless sheet, in time sieve removes the fine powder in the sheet, and qualified sheet is loaded in the sealing clean container.In order to guarantee drug effect and storage period, qualified tablet is packed with aluminium foil, PVC material, can adopt the full-automatic Aluminium-coating Packer of DPP-250D II type during packing, heat sealed package under 100-160 ℃, pressure 0.4MPa, and this packing claims inner packing; For sell, storage and transport are convenient, also can carry out outer package again, are about to aluminium-plastic panel and put into multiple box bag, refill box, vanning.Packaging standard is OTC0.5g/ sheet * 12 slice/plate * 1 plate/box or 0.5g/ sheet * 12 slice/plate * 2 plates/box, includes metronidazole 3mg because of every, so be written as 3mg/ sheet * 12 slice/plate * 1 plate/box or 3mg/ sheet * 12 slice/plate * 2 plates/box again.
The shading of this tablet, sealing are preserved, and it is 2 years that time limit is arranged, and the rate that makes of tablet is more than 97%.This invention tablet oral cavity buccal, three times on the one, each a slice can directly act on pathogen, has avoided the general toxic reaction of medicine, reaches the purpose of directly curing the disease.The present invention's uniqueness of filling a prescription, production method advanced person, the mouth cheek sheet of making that is convenient to oral application, through clinical verification, pharmaceutical effectiveness is reliable, and every technical specification all meets or exceeds country to the antibiotic medicine specified standard, has obtained gratifying effect.
Efficiently: the highest 63.25 μ g/ml of saliva medicine metronidazole concentration that measure during medication, minimum is 47.33 μ g/ml, this concentration is 8-6 times of metronidazole minimum inhibitory concentration 8 μ g/ml, be about 10 times of oral metronidazole (200mg/ time) saliva concentration (4.9 μ g/ml), be enough to kill all anaerobe in the oral cavity, evident in efficacy.
Quick-acting: medication is after five minutes, and the saliva concentration can reach effective Mlc, and generally after 1.5 hours, symptom just can be eased, even disappears.
Low toxicity: this product is the 1/50-1/100 of oral metronidazole dosage every day (600-1200mg) by four calculating every day, and dosage is little, and toxicity is low.Because local application has avoided general toxic reaction, and there are not allergy and irritative response.
Slow release: this product is selected well behaved slow molten blocker for use, tablet is stopped in the oral cavity reach 1.5 hours, and this has just guaranteed that medicine has adequate time to act on pathogen, the stripping quantity value stabilization.
Tasty and refreshing: the refrigerant sweet part omitted of this product is bitter, and mouthfeel is pure and fresh, feels good.
Treatment target: medicine of the present invention is mainly used in oral cavity common diseases such as periodontitis, gingivitis, pericoronitis, to have a toothache, symptom such as gingival hemorrhage, red swelling of gingiva, halitosis, odontoseisis, periodontal pyorrhea all has excellent curative.
Administrated method: before taking medicine, gargle at every turn, put the gum buccal position of this product then, do not chew slow pharynx, make saliva soak into lesions position, treat till the tablet off-bottom in the lesion, oral cavity with cold water.
Dosage: each a slice, every day three times, in buccal after meal, serious symptom adds just before going to bed and contains a slice, and effect is better, the 4-12 days course of treatment, behind the transference cure, should continue buccal 1-2 days, or follow the doctor's advice.
Untoward reaction: the individual patient idol has obvious mouthful of astringent taste.
Contraindication: anemia of pregnant woman and women breast-feeding their children's forbidding.
Points for attention: during containing, please don't stir at every turn, not gargle in half an hour at least after the containing.
Clinical experiment, satisfactory, concrete condition is as follows:
The whole clinical experiment of this product is to finish under department of stomatology expert presides over, clinical case is by diagnosis Standard Selection patient, and criterion of therapeutical effect is pressed the national regulation evaluation, and therapeutic scheme is to establish matched group, test group is carried out, administration is undertaken by the consumption requirement, and the present invention sucks clothes three times on the 1st, each 1, clinical case 510 examples, wherein treatment group is 300 examples, and matched group is 210 examples, is matched group with cydiodine.
Clinical test results is as follows:
(1) the doing well,improving situation of disease is relatively:
| Group | The treatment group | Matched group | Ridit analyzes |
| Gingivitis test group periodontitis test group | 96.9％(376/388) 85.07％(450/529) | 90.53％(239/264) 79.94％(287/359) | u＝3.46＞u 0.01＝2.58 p＜0.01 u＝1.99＞u 0.05＝1.96 p＜0.05 |
Credit is analysed (Ridit analysis) result and is shown that the treatment group obviously is better than matched group (p＜0.01, p＜0.05) to the doing well,improving of gingivitis, periodontitis by statistics.
(2) treatment group and matched group curative effect are relatively
| The sick kind | The treatment group | Matched group | ||||||||||
| Case load | Cure | Produce effects | Effectively | Invalid | Effective percentage (%) | Case load | Cure | Produce effects | Effectively | Invalid | Effective percentage (%) | |
| Gingivitis periodontitis pericoronitis | 100 100 100 | 58 34 70 | 28 39 23 | 12 19 3 | 2 8 4 | 98.00 92.00 97.00 | 70 70 70 | 28 12 40 | 29 34 20 | 10 17 4 | 3 7 2 | |
After the medication, close to two groups of the total effective rates of gingivitis, be respectively treatment group 98.00%, matched group 95.71%, but in the case to cure case, up to 58%, Ridit analyzes, two groups of curative effects are u=2.39＞u relatively
0.05=1.96, p＜0.05; The situation of periodontitis, treatment group cure rate is 34%, analyzes u and matched group is 17.14%, two group of general curative effect through Ridit
0.05=1.96, there is significant difference p＜0.05, and two groups of curative effects to pericoronitis are all based on healing, and general curative effect is also variant.
The long and shows that through the clinical trial of 510 examples, the treatment group is improved by the cardinal symptom of gingivitis and general curative effect all is better than matched group (p＜0.05); Though it is two groups of curative effects to pericoronitis are close, do not contain iodine in the tablet of the present invention, therefore, more suitable to patient's this product of iodine allergy.
(3) pharmacodynamics test
Discharging time limit and Concentration in Saliva measures
Trial volunteer five people (adult: man 4, woman 1), earlier with clear water gargle, each ptysis 3ml, as the normal value that contains before the tablet, everyone respectively contains this product a slice, put between the gum cheek, do not chew not pharynx, every five minutes ptysis 3ml,, get altogether 18 times to 1.5 hours, each accurate saliva 1ml that draws, add 2ml boric acid-potassium chloride buffer, add 7ml chloroform shake well after shaking up and extract, measure trap at 285nm with spectrophotometer, on saliva medicine standard curve, find the concentration that contains metronidazole in the saliva, see the following form:
Saliva medicine time limit determination test is table as a result
| The pastille time (minute) | Average concentration (μ g/ml) | Standard degree (SD) | Accumulation concentration (μ g/ml) | The pastille time (minute) | Average concentration (μ g/ml) | Standard degree (SD) |
| 5 10 15 20 25 30 35 40 45 | 51.17 63.25 60.25 47.33 57.32 56.73 61.96 54.41 50.15 | 4.23 8.55 7.26 6.07 6.38 4.30 9.09 2.14 8.00 | 51.17 114.42 174.42 221.75 279.07 335.80 397.49 451.90 502.05 | 50 55 60 65 70 75 80 85 90 | 49.26 53.81 55.49 49.46 56.92 59.01 61.30 56.58 50.00 | 8.44 6.05 6.92 9.86 4.83 3.20 12.01 2.65 8.05 |
The result shows drug effect concentration longer duration, can fully act on pathogen, guarantees curative effect.
Extracorporeal bacteria inhibitor test: from patient's mouth cacodontia dirt, tell four kind of 31 strain of common anaerobe, wherein bacteroides melanogenicus 11 strains, bacteroides fragilis 7 strains are not understood 4 strains of saccharide bacillus, Streptococcus anaerobius 9 strains, measure through minimum inhibitory concentration (MIC), wherein 29 strain MIC are 4 μ g/ml, and it is 8 μ g/ml that two strain MIC are arranged, and illustrate that medicine of the present invention is reliable to the microbial oral disease curative effect of anaerobism.
Claims (3)
1, a kind of mouth cheek sheet for the treatment of oral anaerobe infection disease, it is characterized in that, be to be that the alcoholic solution 5.5-6.5kg of 50-60% and the magnesium stearate of the dried granule total amount of medicine 0.8-1.2% are made by metronidazole 0.18-0.22kg, sodium carboxymethyl cellulose 0.8-1.0kg, dextrin 1.8-2.2kg, stevioside 0.5-0.7kg, mannitol 9-11kg, sucrose 18-22kg, citric acid 300-360g, Mentholum 40-48g, Oleum menthae 30-36ml, essence 30-36ml, mass concentration.
2; the production method of the mouth cheek sheet of treatment oral anaerobe infection disease according to claim 1; it is characterized in that; with sucrose; mannitol; metronidazole; sodium carboxymethyl cellulose; dextrin; the stevioside pulverize separately sieves; by the dosage requirement; with sucrose 18-22kg; mannitol 9-11kg; metronidazole 0.18-0.22kg; sodium carboxymethyl cellulose 0.8-1.0kg; dextrin 1.8-2.2kg and stevioside 0.5-0.7kg put in the mixing arrangement; mixing; with mass concentration is that 95% ethanol adds water and makes the alcoholic solution 5.5-6.5kg that mass concentration is 50-60%; add citric acid 300-360g and become wetting agent; wetting agent is added in the composite medicated powder; place granulator to granulate; place baking oven again; 18-26 ℃ of following dehumidifying 20-30 minute post-heating drying; baking temperature is 70-75 ℃; 55-65 minute stirring once; tiling evenly; continued dry 35-45 minute; behind the stirring; descended dry 2.5-3 hour at 70-75 ℃; to doing; in pelletizing machine behind the granulate; placing container with Mentholum 40-48g; Oleum menthae 30-36ml is mixed into the spray of volatile oil mixed liquor with essence 30-36ml and is added in the dry granular; mixed 2-3 minute; the magnesium stearate that adds dried granule gross weight 0.8-1.2%; roll and mixed 2-3 minute, reuse mixer mix homogeneously, compacting is in flakes.
3; the production method of the mouth cheek sheet of treatment oral anaerobe infection disease according to claim 2; it is characterized in that; with sucrose; mannitol is ground into 80 order fine powders with Universalpulverizer respectively; metronidazole; sodium carboxymethyl cellulose is crossed 100 mesh sieves respectively; dextrin; stevioside is crossed 60 mesh sieves respectively; by ratio requirement; with metronidazole 0.2kg; sodium carboxymethyl cellulose 0.9kg; stevioside 0.6kg; dextrin 2kg; mannitol 10kg; sucrose 20kg places three-dimensional motion mixer; mixed 30 minutes; to be 55% alcoholic solution 6kg by mass concentration again adds in the medicated powder of mix homogeneously with the miscible wetting agent that becomes of citric acid 330g; place high efficient mixed granulator; stir; cut 2-3 minute; place oscillating granulator to granulate again again with 12 order stainless steel meshs; afterwards; be contained in the stainless steel disc; every dish grain thickness 3.5cm; place heated-air circulation oven; at 25 ℃ of following air blast dehumidifying after 25 minutes; again at 70 ℃ of following heat dryings; stirring once after 60 minutes; tiling evenly; continued dry 40 minutes; stirring once again; dry 3 hours; become water content and be 2% dried granule; the quick crushing and pelletizing machine of reuse is loaded onto 14 order stainless steel meshs and is carried out quick granulate; afterwards, with Mentholum 44g; the volatile oil mixed liquor that Oleum menthae 33ml and essence 33ml are mixed and made into is sprayed in the dried granule, mixes 3 minutes; after again the magnesium stearate of 337 grams being crossed 100 mesh sieves; add in the granule in rolling, mixed 2.5 minutes, place the two dimensional motion mixer again; mixed 30 minutes; with the tablet machine compacting in flakes, every 0.5 gram includes metronidazole 3mg.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410060435 CN1263449C (en) | 2004-08-02 | 2004-08-02 | Buccal tablet for treating oral anaerobe infection disease and its manufacturing method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410060435 CN1263449C (en) | 2004-08-02 | 2004-08-02 | Buccal tablet for treating oral anaerobe infection disease and its manufacturing method |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1602861A CN1602861A (en) | 2005-04-06 |
| CN1263449C true CN1263449C (en) | 2006-07-12 |
Family
ID=34666301
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200410060435 Expired - Fee Related CN1263449C (en) | 2004-08-02 | 2004-08-02 | Buccal tablet for treating oral anaerobe infection disease and its manufacturing method |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1263449C (en) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100425232C (en) * | 2006-06-08 | 2008-10-15 | 武汉远大制药集团有限公司 | Buccale tablet preparation and its making method |
| CN110859815A (en) * | 2019-12-05 | 2020-03-06 | 远大医药（中国）有限公司 | Metronidazole preparation and preparation method thereof |
-
2004
- 2004-08-02 CN CN 200410060435 patent/CN1263449C/en not_active Expired - Fee Related
Also Published As
| Publication number | Publication date |
|---|---|
| CN1602861A (en) | 2005-04-06 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN101099729B (en) | Oral solid preparation containing ambroxol hydrochloride and salbutamol active components | |
| EP0732920B1 (en) | Therapeutic agents containing thyroid hormones | |
| EP2328549B1 (en) | Sore throat compositions | |
| EA001898B1 (en) | Intraorally rapidly disintegrating tablet | |
| CN101455627A (en) | Use of beautyberry extract in oral-cavity cleaning products | |
| JPH07242557A (en) | Evacuant composition containing lactic acid bacterium | |
| WO2001076565A1 (en) | Compositions disintegrating in oral cavity and preparations disintegrating in oral cavity | |
| CN104922148A (en) | Particulate compositions comprising alginate and/or alginic acid | |
| CN110314110A (en) | A kind of effervescent tablet type mouthwash and preparation method thereof | |
| JP3064417B2 (en) | Controlled release formulations and methods | |
| WO2005084703A1 (en) | Sustained-release composition for oral cavity | |
| CN103040773A (en) | Doxycycline metal complex in a solid dosage form | |
| CN1263449C (en) | Buccal tablet for treating oral anaerobe infection disease and its manufacturing method | |
| CN100366288C (en) | Dental ulcerative glue | |
| CN1309425C (en) | Treating canker sores with patches to speed healing and relieve pain | |
| CN101062119A (en) | Buccal tablets having function of preventing decayed tooth and the preparing method thereof | |
| CN1297304C (en) | Aquilarid distillate suspensoid agent and its preparation method | |
| CN100345542C (en) | Tinizadole dental plaster for treating buccal inflammation | |
| CN1284585C (en) | Medicine for treating acute and chronic pharyogolaryngitis, recurring oral cavity sore and its preparation method | |
| CN101879211A (en) | Chinese medicinal preparation for clearing heat, relieving sore-throat and stopping pain and preparation method thereof | |
| TWI343818B (en) | ||
| CN105497068A (en) | Buccal patch containing artificial bezoar and metronidazole and preparation method of buccal patch | |
| CN100384407C (en) | Chinese medicine oral cavity adherent emplastrum and its preparation method | |
| CN1377645A (en) | Tea polyphenol buccal tablet for preventing and curing tooth decay and its preparing method | |
| CN113951412A (en) | Probiotic instant solid beverage for regulating health of oral cavity and throat and preparation method thereof |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| ASS | Succession or assignment of patent right |
Owner name: JIANGXI GUANGXIN PHARMACEUTICAL CO., LTD. Free format text: FORMER OWNER: ZHENG TANGHUA Effective date: 20090508 |
|
| C41 | Transfer of patent application or patent right or utility model | ||
| TR01 | Transfer of patent right |
Effective date of registration: 20090508 Address after: Jiangxi County in Guangfeng Province Lu Lin Industrial Zone Patentee after: JIANGXI GUANGXIN PHARMACEUTICAL Co.,Ltd. Address before: No. 1, Jinshui Road, Henan, Zhengzhou, Henan University of Traditional Chinese Medicine, College of pharmacy, Miao Ming, three Patentee before: Zheng Tanghua |
|
| PE01 | Entry into force of the registration of the contract for pledge of patent right |
Denomination of invention: Buccal tablet for treating oral anaerobe infection and its production method Effective date of registration: 20220525 Granted publication date: 20060712 Pledgee: Bank of China Limited Guangfeng sub branch Pledgor: JIANGXI GUANGXIN PHARMACEUTICAL Co.,Ltd. Registration number: Y2022980006435 |
|
| PE01 | Entry into force of the registration of the contract for pledge of patent right | ||
| PC01 | Cancellation of the registration of the contract for pledge of patent right |
Date of cancellation: 20230509 Granted publication date: 20060712 Pledgee: Bank of China Limited Guangfeng sub branch Pledgor: JIANGXI GUANGXIN PHARMACEUTICAL Co.,Ltd. Registration number: Y2022980006435 |
|
| PC01 | Cancellation of the registration of the contract for pledge of patent right | ||
| PE01 | Entry into force of the registration of the contract for pledge of patent right |
Denomination of invention: Buccal film and its production method for treating oral anaerobic bacterial infections Effective date of registration: 20230511 Granted publication date: 20060712 Pledgee: Bank of China Limited Guangfeng sub branch Pledgor: JIANGXI GUANGXIN PHARMACEUTICAL Co.,Ltd. Registration number: Y2023980040430 |
|
| PE01 | Entry into force of the registration of the contract for pledge of patent right | ||
| CF01 | Termination of patent right due to non-payment of annual fee |
Granted publication date: 20060712 |