CN105287625A - Hydrotalcite combined medicine tablet as well as preparation method and application thereof - Google Patents
Hydrotalcite combined medicine tablet as well as preparation method and application thereof Download PDFInfo
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- CN105287625A CN105287625A CN201510889941.XA CN201510889941A CN105287625A CN 105287625 A CN105287625 A CN 105287625A CN 201510889941 A CN201510889941 A CN 201510889941A CN 105287625 A CN105287625 A CN 105287625A
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- CN
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- Prior art keywords
- hydrotalcite
- medicine tablet
- stachyose
- sucralose
- lactose
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- 229960001545 hydrotalcite Drugs 0.000 title claims abstract description 53
- 229910001701 hydrotalcite Inorganic materials 0.000 title claims abstract description 53
- GDVKFRBCXAPAQJ-UHFFFAOYSA-A dialuminum;hexamagnesium;carbonate;hexadecahydroxide Chemical compound [OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[Mg+2].[Mg+2].[Mg+2].[Mg+2].[Mg+2].[Mg+2].[Al+3].[Al+3].[O-]C([O-])=O GDVKFRBCXAPAQJ-UHFFFAOYSA-A 0.000 title claims abstract description 52
- 239000003814 drug Substances 0.000 title claims abstract description 34
- 238000002360 preparation method Methods 0.000 title claims abstract description 17
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims abstract description 28
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims abstract description 14
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims abstract description 14
- UQZIYBXSHAGNOE-USOSMYMVSA-N Stachyose Natural products O(C[C@H]1[C@@H](O)[C@H](O)[C@H](O)[C@@H](O[C@@]2(CO)[C@H](O)[C@@H](O)[C@@H](CO)O2)O1)[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@H](CO[C@@H]2[C@@H](O)[C@@H](O)[C@@H](O)[C@H](CO)O2)O1 UQZIYBXSHAGNOE-USOSMYMVSA-N 0.000 claims abstract description 14
- 239000004376 Sucralose Substances 0.000 claims abstract description 14
- 239000008101 lactose Substances 0.000 claims abstract description 14
- 235000019359 magnesium stearate Nutrition 0.000 claims abstract description 14
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims abstract description 14
- 239000008108 microcrystalline cellulose Substances 0.000 claims abstract description 14
- 229940016286 microcrystalline cellulose Drugs 0.000 claims abstract description 14
- 229960000540 polacrilin potassium Drugs 0.000 claims abstract description 14
- WVWZXTJUCNEUAE-UHFFFAOYSA-M potassium;1,2-bis(ethenyl)benzene;2-methylprop-2-enoate Chemical compound [K+].CC(=C)C([O-])=O.C=CC1=CC=CC=C1C=C WVWZXTJUCNEUAE-UHFFFAOYSA-M 0.000 claims abstract description 14
- UQZIYBXSHAGNOE-XNSRJBNMSA-N stachyose 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[C@@H]2[C@@H]([C@@H](O)[C@@H](O)[C@@H](CO[C@@H]3[C@@H]([C@@H](O)[C@@H](O)[C@@H](CO)O3)O)O2)O)O1 UQZIYBXSHAGNOE-XNSRJBNMSA-N 0.000 claims abstract description 14
- 235000019408 sucralose Nutrition 0.000 claims abstract description 14
- BAQAVOSOZGMPRM-QBMZZYIRSA-N sucralose Chemical compound O[C@@H]1[C@@H](O)[C@@H](Cl)[C@@H](CO)O[C@@H]1O[C@@]1(CCl)[C@@H](O)[C@H](O)[C@@H](CCl)O1 BAQAVOSOZGMPRM-QBMZZYIRSA-N 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 12
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims abstract description 10
- ZLNQQNXFFQJAID-UHFFFAOYSA-L magnesium carbonate Chemical compound [Mg+2].[O-]C([O-])=O ZLNQQNXFFQJAID-UHFFFAOYSA-L 0.000 claims abstract description 3
- 239000001095 magnesium carbonate Substances 0.000 claims abstract description 3
- 229910000021 magnesium carbonate Inorganic materials 0.000 claims abstract description 3
- 239000000203 mixture Substances 0.000 claims description 24
- 229940008099 dimethicone Drugs 0.000 claims description 21
- 239000004205 dimethyl polysiloxane Substances 0.000 claims description 21
- 235000013870 dimethyl polysiloxane Nutrition 0.000 claims description 21
- 229920000435 poly(dimethylsiloxane) Polymers 0.000 claims description 21
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 12
- 239000012895 dilution Substances 0.000 claims description 8
- 238000010790 dilution Methods 0.000 claims description 8
- AMTWCFIAVKBGOD-UHFFFAOYSA-N dioxosilane;methoxy-dimethyl-trimethylsilyloxysilane Chemical compound O=[Si]=O.CO[Si](C)(C)O[Si](C)(C)C AMTWCFIAVKBGOD-UHFFFAOYSA-N 0.000 claims description 7
- 229940083037 simethicone Drugs 0.000 claims description 7
- 239000000377 silicon dioxide Substances 0.000 claims description 6
- 238000000034 method Methods 0.000 claims description 4
- 239000000843 powder Substances 0.000 claims description 4
- 235000012239 silicon dioxide Nutrition 0.000 claims description 4
- 238000013019 agitation Methods 0.000 claims description 3
- 238000007907 direct compression Methods 0.000 claims description 3
- 238000010348 incorporation Methods 0.000 claims description 3
- 238000010438 heat treatment Methods 0.000 claims description 2
- 239000012808 vapor phase Substances 0.000 claims description 2
- 230000003902 lesion Effects 0.000 claims 1
- 210000001156 gastric mucosa Anatomy 0.000 abstract description 6
- 230000035876 healing Effects 0.000 abstract description 4
- 238000004519 manufacturing process Methods 0.000 abstract description 4
- 238000012864 cross contamination Methods 0.000 abstract description 2
- 238000005265 energy consumption Methods 0.000 abstract description 2
- 239000002245 particle Substances 0.000 abstract description 2
- 239000000463 material Substances 0.000 abstract 2
- NOOLISFMXDJSKH-UTLUCORTSA-N (+)-Neomenthol Chemical compound CC(C)[C@@H]1CC[C@@H](C)C[C@@H]1O NOOLISFMXDJSKH-UTLUCORTSA-N 0.000 abstract 1
- 239000002253 acid Substances 0.000 abstract 1
- 230000007012 clinical effect Effects 0.000 abstract 1
- 238000005516 engineering process Methods 0.000 abstract 1
- 229940041616 menthol Drugs 0.000 abstract 1
- CXQXSVUQTKDNFP-UHFFFAOYSA-N octamethyltrisiloxane Chemical class C[Si](C)(C)O[Si](C)(C)O[Si](C)(C)C CXQXSVUQTKDNFP-UHFFFAOYSA-N 0.000 abstract 1
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 11
- 239000013641 positive control Substances 0.000 description 8
- 230000006378 damage Effects 0.000 description 7
- 229940069428 antacid Drugs 0.000 description 5
- 239000003159 antacid agent Substances 0.000 description 5
- 230000001458 anti-acid effect Effects 0.000 description 5
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical class [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 description 4
- 208000027418 Wounds and injury Diseases 0.000 description 4
- 229940079593 drug Drugs 0.000 description 4
- 230000000694 effects Effects 0.000 description 4
- 208000014674 injury Diseases 0.000 description 4
- 210000004877 mucosa Anatomy 0.000 description 4
- 230000001681 protective effect Effects 0.000 description 4
- 210000001187 pylorus Anatomy 0.000 description 4
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 3
- 102000057297 Pepsin A Human genes 0.000 description 3
- 108090000284 Pepsin A Proteins 0.000 description 3
- 208000025865 Ulcer Diseases 0.000 description 3
- 235000009508 confectionery Nutrition 0.000 description 3
- 229960004756 ethanol Drugs 0.000 description 3
- 210000004051 gastric juice Anatomy 0.000 description 3
- 230000007774 longterm Effects 0.000 description 3
- 229940111202 pepsin Drugs 0.000 description 3
- 238000012360 testing method Methods 0.000 description 3
- 229940126680 traditional chinese medicines Drugs 0.000 description 3
- 231100000397 ulcer Toxicity 0.000 description 3
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 2
- WSMYVTOQOOLQHP-UHFFFAOYSA-N Malondialdehyde Chemical compound O=CCC=O WSMYVTOQOOLQHP-UHFFFAOYSA-N 0.000 description 2
- 102000004316 Oxidoreductases Human genes 0.000 description 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 2
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 2
- 230000037396 body weight Effects 0.000 description 2
- 238000006243 chemical reaction Methods 0.000 description 2
- -1 dimethylsiloxane Chemical group 0.000 description 2
- 239000006260 foam Substances 0.000 description 2
- 210000004211 gastric acid Anatomy 0.000 description 2
- 230000002496 gastric effect Effects 0.000 description 2
- 238000011835 investigation Methods 0.000 description 2
- 239000012567 medical material Substances 0.000 description 2
- 238000002156 mixing Methods 0.000 description 2
- 239000002547 new drug Substances 0.000 description 2
- 210000002784 stomach Anatomy 0.000 description 2
- 229960004291 sucralfate Drugs 0.000 description 2
- MNQYNQBOVCBZIQ-JQOFMKNESA-A sucralfate Chemical compound O[Al](O)OS(=O)(=O)O[C@@H]1[C@@H](OS(=O)(=O)O[Al](O)O)[C@H](OS(=O)(=O)O[Al](O)O)[C@@H](COS(=O)(=O)O[Al](O)O)O[C@H]1O[C@@]1(COS(=O)(=O)O[Al](O)O)[C@@H](OS(=O)(=O)O[Al](O)O)[C@H](OS(=O)(=O)O[Al](O)O)[C@@H](OS(=O)(=O)O[Al](O)O)O1 MNQYNQBOVCBZIQ-JQOFMKNESA-A 0.000 description 2
- ASWBNKHCZGQVJV-UHFFFAOYSA-N (3-hexadecanoyloxy-2-hydroxypropyl) 2-(trimethylazaniumyl)ethyl phosphate Chemical compound CCCCCCCCCCCCCCCC(=O)OCC(O)COP([O-])(=O)OCC[N+](C)(C)C ASWBNKHCZGQVJV-UHFFFAOYSA-N 0.000 description 1
- BHQCQFFYRZLCQQ-UHFFFAOYSA-N (3alpha,5alpha,7alpha,12alpha)-3,7,12-trihydroxy-cholan-24-oic acid Natural products OC1CC2CC(O)CCC2(C)C2C1C1CCC(C(CCC(O)=O)C)C1(C)C(O)C2 BHQCQFFYRZLCQQ-UHFFFAOYSA-N 0.000 description 1
- 239000004380 Cholic acid Substances 0.000 description 1
- 102000004190 Enzymes Human genes 0.000 description 1
- 108090000790 Enzymes Proteins 0.000 description 1
- 208000007882 Gastritis Diseases 0.000 description 1
- 206010020601 Hyperchlorhydria Diseases 0.000 description 1
- 208000008469 Peptic Ulcer Diseases 0.000 description 1
- 102000003992 Peroxidases Human genes 0.000 description 1
- 208000019790 abdominal distention Diseases 0.000 description 1
- 230000003213 activating effect Effects 0.000 description 1
- 229910052782 aluminium Inorganic materials 0.000 description 1
- 239000002518 antifoaming agent Substances 0.000 description 1
- 238000003556 assay Methods 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 230000017531 blood circulation Effects 0.000 description 1
- 230000001055 chewing effect Effects 0.000 description 1
- 235000019416 cholic acid Nutrition 0.000 description 1
- BHQCQFFYRZLCQQ-OELDTZBJSA-N cholic acid Chemical compound C([C@H]1C[C@H]2O)[C@H](O)CC[C@]1(C)[C@@H]1[C@@H]2[C@@H]2CC[C@H]([C@@H](CCC(O)=O)C)[C@@]2(C)[C@@H](O)C1 BHQCQFFYRZLCQQ-OELDTZBJSA-N 0.000 description 1
- 229960002471 cholic acid Drugs 0.000 description 1
- 239000013530 defoamer Substances 0.000 description 1
- 229960000935 dehydrated alcohol Drugs 0.000 description 1
- KXGVEGMKQFWNSR-UHFFFAOYSA-N deoxycholic acid Natural products C1CC2CC(O)CCC2(C)C2C1C1CCC(C(CCC(O)=O)C)C1(C)C(O)C2 KXGVEGMKQFWNSR-UHFFFAOYSA-N 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 229940088598 enzyme Drugs 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 206010016766 flatulence Diseases 0.000 description 1
- 239000003205 fragrance Substances 0.000 description 1
- 239000007789 gas Substances 0.000 description 1
- 238000003304 gavage Methods 0.000 description 1
- 210000004907 gland Anatomy 0.000 description 1
- 238000003306 harvesting Methods 0.000 description 1
- 230000003859 lipid peroxidation Effects 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 230000014759 maintenance of location Effects 0.000 description 1
- 230000000813 microbial effect Effects 0.000 description 1
- 239000004570 mortar (masonry) Substances 0.000 description 1
- 230000009854 mucosal lesion Effects 0.000 description 1
- 229910052757 nitrogen Inorganic materials 0.000 description 1
- 208000011906 peptic ulcer disease Diseases 0.000 description 1
- 108040007629 peroxidase activity proteins Proteins 0.000 description 1
- 239000008194 pharmaceutical composition Substances 0.000 description 1
- 239000012071 phase Substances 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
- 150000003180 prostaglandins Chemical class 0.000 description 1
- 239000011780 sodium chloride Substances 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 238000003756 stirring Methods 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 238000003786 synthesis reaction Methods 0.000 description 1
Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention aims at providing a hydrotalcite combined medicine tablet which has acid resistance and strong defoaming ability and is stable for a long period of time, and a preparation method. The hydrotalcite combined medicine tablet is prepared from magnesium carbonate, activated dimeticone, polacrilin potassium, stachyose, microcrystalline cellulose, sucralose, lactose, menthol and magnesium stearate. According to the preparation formula and the preparation method provided by the invention, the particle sizes of raw and auxiliary materials are controlled; the fluidity after the raw and auxiliary materials are mixed can be significantly increased; the hydrotalcite combined medicine tablet is free of viscidity to teeth after being chewed, free of sense of gravels, fragrant, delicious, applicable to industrial mass production, simple in technology, low in cross contamination and low in energy consumption; the production cost is reduced; more importantly, the obtained hydrotalcite combined medicine tablet can effectively play a protecting role on gastric mucosa; the healing quality of anabrosis is improved; the clinical effect is also superior to that of a hydrotalcite table variety sold on the market.
Description
Technical field
The present invention relates to a kind of medicine for diseases such as hyperchlorhydria, gastritis, peptic ulcer, flatulence and heartburies, a kind of hydrotalcite composition of medicine tablet, preparation method and application thereof in particular.
Technical background
Hydrotalcite is a kind of antacid, and has mucosa concurrently.Oral hydrotalcite can fast in and gastric acid, and to be combined with pepsin, cholic acid, LYSOLECITHIN SUNLECITHIN A, to weaken the damage factor of gastric mucosa; promote synthesis and the release of prostaglandin simultaneously; promote mucosal blood flow, thus strengthen the protective effect of gastric mucosa, be beneficial to ulcer healing.Simethicone (Ddimethicone), chemical name is dimethylsiloxane polymer.Itself does not almost have defoaming capacity, and it is after stirring with silicon dioxide, becomes the activated dimethicone of superpower defoaming capacity after at high temperature activating certain hour, is medically used as defoamer, alleviates the abdominal distention etc. because gas retention causes.
Summary of the invention
In order to overcome the drawback that existing dosage form exists, the object of this invention is to provide a kind of have simultaneously capacity antacid and powerful defoaming capacity, hydrotalcite medicinal composition tablets steady in a long-term and preparation method.Wherein, described hydrotalcite composition of medicine tablet is made up of magnesium carbonate, activated dimethicone, polacrilin potassium, stachyose, microcrystalline Cellulose, sucralose, lactose, Mentholum and magnesium stearate.
The granularity of described hydrotalcite, polacrilin potassium, stachyose, microcrystalline Cellulose, sucralose, lactose and magnesium stearate is less than 200 microns.
Described activated dimethicone is after simethicone and vapor phase method or precipitated silica are mixed in proportion, under 100-150 DEG C of condition, and the activated dimethicone of reacting by heating 0.5-5 hour.Described silicon dioxide and the weight ratio of simethicone are 0.5-5:1-10.
The weight ratio of described hydrotalcite, activated dimethicone, polacrilin potassium, stachyose, microcrystalline Cellulose, sucralose, lactose, Mentholum and magnesium stearate is: 500-1000:50-150:50-200:50-250:100-200:1-5:200-500:1-2:10-20.In concrete application, containing hydrotalcite 500-1000g, activated dimethicone 50-150g, polacrilin potassium 50-200g, stachyose 50-250g, microcrystalline Cellulose 100-200g, sucralose 1-5g, lactose 200-500g, Mentholum 1-2g and magnesium stearate 10-20g in every 1000 preparation unit.
The preparation method of described hydrotalcite composition of medicine tablet, comprises as follows:
1) make by hydrotalcite, polacrilin potassium, stachyose, microcrystalline Cellulose, sucralose, lactose, Mentholum and magnesium stearate the powder that granularity is less than 200 microns;
2) lactose and the microcrystalline Cellulose of getting recipe quantity add agitation and dilution in the activated dimethicone of recipe quantity, then cross 80 mesh sieves and obtain activated dimethicone dilution;
3) finally by hydrotalcite, polacrilin potassium, activated dimethicone dilution, Mentholum, sucralose, magnesium stearate, stachyose adds in three-dimensional motion mixer, incorporation time 15-30 minute, obtains always mixed thing;
4) namely total mixed thing direct compression obtains hydrotalcite composition of medicine tablet.
Advantageous Effects of the present invention is: pharmaceutical formulation provided by the invention and preparation method significantly can increase the mixed mobility of supplementary material at control supplementary material particle diameter, and do not stick to one's teeth after chewing tooth, and without grittiness, fragrance is good to eat, is applicable to industrialized great production; And this technique is simple, and cross-contamination is few, and energy consumption is low, reduces production cost.The more important thing is, the hydrotalcite composition of medicine tablet obtained by the present invention can effectively be played a protective role to gastric mucosa, and improve the healing quality of ulcer, its clinical effectiveness is also better than commercially available hydrotalcite tablet kind.
Detailed description of the invention
The preparation of embodiment 1 hydrotalcite composition of medicine tablet
1, take and get silicon dioxide 5g, after simethicone 50g Homogeneous phase mixing, under 115 DEG C of conditions, the heat-activated activated dimethicone of 2 hours.Supplementary material is taken according to prescription 1.
Prescription 1
The first step, according to the parameter of formula 1, takes supplementary material, and hydrotalcite, polacrilin potassium, stachyose, microcrystalline Cellulose, sucralose, lactose, Mentholum and magnesium stearate be processed into the powder that granularity is less than 200 microns.
Second step, lactose and the microcrystalline Cellulose of getting recipe quantity add agitation and dilution in the activated dimethicone of recipe quantity, then 80 mesh sieves are crossed for subsequent use, finally by hydrotalcite, polacrilin potassium, activated dimethicone dilution, Mentholum, sucralose, magnesium stearate, stachyose adds in three-dimensional motion mixer, incorporation time 15-30 minute, obtains always mixed thing.
3rd step, namely obtains hydrotalcite composition of medicine tablet, called after experimental group A by always mixing thing direct compression.
2, take medical material according to the weight of prescription 2 and prepare activated dimethicone, experimentally organize the preparation method of A hydrotalcite composition of medicine tablet, prepare hydrotalcite composition of medicine tablet, called after experimental group B.
Prescription 2
2, take medical material according to the weight of prescription 3 and prepare activated dimethicone, experimentally organize the preparation method of A hydrotalcite composition of medicine tablet, prepare hydrotalcite composition of medicine tablet, called after experimental group C.
Prescription 3
Embodiment 2 couples of experimental grouies A, B, C detect
1. Testing index
Outward appearance: should be white or off-white color sheet
Disintegration: see Chinese Pharmacopoeia version in 2015 the 4th the 118th page, method label 0921;
3 antifoam performances: get above-mentioned hydrotalcite compositions sheet 1, put porphyrize in mortar, get 2 clean 250ml graduated cylinders, add the TritonX solution of 50ml1% respectively, the medicated powder of porphyrize is poured into gently wherein in a graduated cylinder, seal graduated cylinder and buckle, same powerful jolting 5 times, 1min counts out foam height, with without adding that graduated cylinder of medication amount for 100%, calculating defoaming capacity should be not less than 80% with the foam volume of test sample minimizing;
Weight differential: see Chinese Pharmacopoeia version in 2015 the 4th page 4;
Microbial limit: see Chinese Pharmacopoeia version in 2015 the 4th 140-151 page;
Friability: see Chinese Pharmacopoeia version in 2015 the 4th the 120th page;
Hydrotalcite antacid power: new drug is become a full member standard the 48th Western medicine part the 12nd page.
2, assay
Version in 2015 two 19 pages is shown in by simethicone;
Hydrotalcite is shown in that new drug is become a full member standard the 48th Western medicine part the 12nd page.
Wherein, the testing result of experimental group A, B, C is specifically as shown in table 1,2,3.
The quality examination result of table 1 experimental group A
The quality examination result of table 2 experimental group B
The quality examination result of table 3 experimental group C
The study on the stability of embodiment 3 experimental group A, B, C
Investigate sample experiments group A, B, C investigate through long-term (condition: 25 ± 2 DEG C, RH60% ± 10%) for 36 months.Investigate result as shown in table 4,5,6:
Table 4 experimental group A sample stability investigates result
Table 5 experimental group B sample stability investigates result
Table 6 experimental group C sample study on the stability result
Result shows 36 months long-term investigation, and experimental group A, B, C indices is without significant change.
The activity of embodiment 4 hydrotalcite medicinal composition tablets is investigated
1. pylorus ligation Mus (Shay rat) model: Wistar male rat (body weight 190g-220g) is divided into matched group, experimental group A, B, C group, positive controls 1 and positive controls 2, the hydrotalcite tablet (the accurate word H20153169 of traditional Chinese medicines) that wherein positive controls 1 administration is commercially available, the commercially available thiosugar aluminium flake (the accurate word H20057241 of traditional Chinese medicines) of positive controls 2 administration often organizes 6.Wherein respectively organize dosage and be conversion hydrotalcite crude drug and sucralfate crude drug 500mg/kgd, totally 3 times, matched group only gives saline.After last administration, the equal ligation pylorus of each group, 4 h before harvest gastric juice also measure gland Gastric mucosal injury index, and damage index represents with mucosa injury length (mm).Gastric juice is for measuring pepsin activity and gastric acidity.Specifically as shown in table 7.
Table 7 is on the protective effect of pylorus ligation Mus gastric mucosa and the impact on gastric acid, pepsin and gastric juice
* P<0.05 is compared with matched group; * P<0.001.
Anhydrous alcohol damage model: Wistar male rat (body weight 190g-220g) is divided into matched group, experimental group A, B, C, positive controls and ethanol group, the hydrotalcite tablet (the accurate word H20153169 of traditional Chinese medicines) that wherein positive controls 1 administration is commercially available, often organizes rat 6.Experimental group A, B, C, positive controls given low are conversion hydrotalcite crude drug 500mg/kg.d, totally 3 times.Last administration is after 1 hour, and experimental group A, B, C, positive controls and ethanol group gavage dehydrated alcohol, and matched group only gives normal saline.Rat is put to death after 1 hour to ethanol, get stomach, measure mucosa injury index, stomach is in liquid nitrogen flash freezer,-70 DEG C of Refrigerator stores, awake reductase (QR) to be measured, the sweet skin of paddy moon bright-S-transferring enzyme (GSTs), paddy moon bright sweet skin reductase (GR), the sweet skin peroxidase (GSH-PX) of paddy moon bright and lipid peroxidation product malonaldehyde (MDA) content.
Table 8 pair ethanol brings out the protection of mucosal lesion, resists the investigation of oxidasic reduction and lipoid peroxidization resistant
Note: compare * P<0.05 with ethanol group; * P<0.001; With matched group Bi compare ﹟ P<0.05 ， ﹟ ﹟ P<0.001.
Hydrotalcite is antacid, and the antacid containing aluminum generally has mucosa concurrently, and improves the healing quality of ulcer.Hydrotalcite tablet provided by the invention has remarkable protective effect to the gastric mucosa injury that pylorus ligation Mus and ethanol are brought out, and its effect is better than commercially available hydrotalcite tablet preparation and sucralfate tablet preparation.
Claims (7)
1. a hydrotalcite composition of medicine tablet, is characterized in that: described hydrotalcite composition of medicine tablet is made up of magnesium carbonate, activated dimethicone, polacrilin potassium, stachyose, microcrystalline Cellulose, sucralose, lactose, Mentholum and magnesium stearate.
2. hydrotalcite composition of medicine tablet according to claim 1, is characterized in that: the granularity of described hydrotalcite, polacrilin potassium, stachyose, microcrystalline Cellulose, sucralose, lactose and magnesium stearate is less than 200 microns.
3. hydrotalcite composition of medicine tablet according to claim 1, it is characterized in that: described activated dimethicone is after simethicone and vapor phase method or precipitated silica are mixed in proportion, under 100-150 DEG C of condition, the activated dimethicone of reacting by heating 0.5-5 hour.
4. hydrotalcite composition of medicine tablet according to claim 3, is characterized in that: described silicon dioxide and the weight ratio of simethicone are 0.5-5:1-10.
5. hydrotalcite composition of medicine tablet according to claim 1, is characterized in that: the weight ratio of described hydrotalcite, activated dimethicone, polacrilin potassium, stachyose, microcrystalline Cellulose, sucralose, lactose, Mentholum and magnesium stearate is 500-1000:50-150:50-200:50-250:100-200:1-5:200-500:1-2:10-20.
6. the preparation method of the hydrotalcite composition of medicine tablet according to any one of claim 1-5, is characterized in that: comprise as follows:
1) make by hydrotalcite, polacrilin potassium, stachyose, microcrystalline Cellulose, sucralose, lactose, Mentholum and magnesium stearate the powder that granularity is less than 200 microns;
2) lactose and the microcrystalline Cellulose of getting recipe quantity add agitation and dilution in the activated dimethicone of recipe quantity, then cross 80 mesh sieves and obtain activated dimethicone dilution;
3) finally by hydrotalcite, polacrilin potassium, activated dimethicone dilution, Mentholum, sucralose, magnesium stearate, stachyose adds in three-dimensional motion mixer, incorporation time 15-30 minute, obtains always mixed thing;
4) namely total mixed thing direct compression obtains hydrotalcite composition of medicine tablet.
7. the application of the hydrotalcite composition of medicine tablet described in any one of claim 1-5 in preparation treatment Gastroduodenal lesion medicine.
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| CN116763753A (en) * | 2023-07-14 | 2023-09-19 | 重庆希尔安药业有限公司 | A compound Chenxiang composition stomach tablet and its preparation method |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101797268A (en) * | 2010-03-11 | 2010-08-11 | 重庆健能医药开发有限公司 | Stable compound dimeticone hydrotalcite suspension |
| CN102151286A (en) * | 2010-12-13 | 2011-08-17 | 四川健能制药有限公司 | Hydrotalcite tablet and preparation method thereof |
| CN102532901A (en) * | 2010-12-21 | 2012-07-04 | 重庆北碚现代应用药物研究所 | Method for preparing simethicone |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101797268A (en) * | 2010-03-11 | 2010-08-11 | 重庆健能医药开发有限公司 | Stable compound dimeticone hydrotalcite suspension |
| CN102151286A (en) * | 2010-12-13 | 2011-08-17 | 四川健能制药有限公司 | Hydrotalcite tablet and preparation method thereof |
| CN102532901A (en) * | 2010-12-21 | 2012-07-04 | 重庆北碚现代应用药物研究所 | Method for preparing simethicone |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN116763753A (en) * | 2023-07-14 | 2023-09-19 | 重庆希尔安药业有限公司 | A compound Chenxiang composition stomach tablet and its preparation method |
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