CN112675192A - Hydrotalcite chewable tablet and preparation method thereof - Google Patents
Hydrotalcite chewable tablet and preparation method thereof Download PDFInfo
- Publication number
- CN112675192A CN112675192A CN202110036123.0A CN202110036123A CN112675192A CN 112675192 A CN112675192 A CN 112675192A CN 202110036123 A CN202110036123 A CN 202110036123A CN 112675192 A CN112675192 A CN 112675192A
- Authority
- CN
- China
- Prior art keywords
- hydrotalcite
- chewable tablet
- percent
- wet
- hydrotalcite chewable
- 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
- 229960001545 hydrotalcite Drugs 0.000 title claims abstract description 43
- 229910001701 hydrotalcite Inorganic materials 0.000 title claims abstract description 43
- 239000007910 chewable tablet Substances 0.000 title claims abstract description 32
- 229940068682 chewable tablet Drugs 0.000 title claims abstract description 28
- 238000002360 preparation method Methods 0.000 title claims abstract description 26
- 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 17
- 239000003826 tablet Substances 0.000 claims abstract description 26
- 239000003814 drug Substances 0.000 claims abstract description 22
- 239000008187 granular material Substances 0.000 claims abstract description 21
- 238000000034 method Methods 0.000 claims abstract description 21
- 238000002156 mixing Methods 0.000 claims abstract description 21
- 239000000314 lubricant Substances 0.000 claims abstract description 17
- 239000003085 diluting agent Substances 0.000 claims abstract description 16
- 239000000796 flavoring agent Substances 0.000 claims abstract description 16
- 235000013355 food flavoring agent Nutrition 0.000 claims abstract description 15
- 239000002994 raw material Substances 0.000 claims description 21
- 235000020985 whole grains Nutrition 0.000 claims description 13
- 238000001035 drying Methods 0.000 claims description 10
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 9
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 8
- 239000011777 magnesium Substances 0.000 claims description 7
- FTLYMKDSHNWQKD-UHFFFAOYSA-N (2,4,5-trichlorophenyl)boronic acid Chemical compound OB(O)C1=CC(Cl)=C(Cl)C=C1Cl FTLYMKDSHNWQKD-UHFFFAOYSA-N 0.000 claims description 6
- 229920002261 Corn starch Polymers 0.000 claims description 6
- 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 description 6
- 229930195725 Mannitol Natural products 0.000 claims description 6
- 239000008120 corn starch Substances 0.000 claims description 6
- 229910052749 magnesium Inorganic materials 0.000 claims description 6
- 239000000594 mannitol Substances 0.000 claims description 6
- 235000010355 mannitol Nutrition 0.000 claims description 6
- 239000008213 purified water Substances 0.000 claims description 6
- 229940085605 saccharin sodium Drugs 0.000 claims description 6
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 claims description 5
- UJOHNXQDVUADCG-UHFFFAOYSA-L aluminum;magnesium;carbonate Chemical compound [Mg+2].[Al+3].[O-]C([O-])=O UJOHNXQDVUADCG-UHFFFAOYSA-L 0.000 claims description 5
- 239000002245 particle Substances 0.000 claims description 5
- 238000005550 wet granulation Methods 0.000 claims description 5
- 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 description 4
- 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 description 4
- CJZGTCYPCWQAJB-UHFFFAOYSA-L calcium stearate Chemical compound [Ca+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O CJZGTCYPCWQAJB-UHFFFAOYSA-L 0.000 claims description 4
- 235000013539 calcium stearate Nutrition 0.000 claims description 4
- 239000008116 calcium stearate Substances 0.000 claims description 4
- 239000008101 lactose Substances 0.000 claims description 4
- 235000019359 magnesium stearate Nutrition 0.000 claims description 4
- 238000007908 dry granulation Methods 0.000 claims description 3
- 239000000080 wetting agent Substances 0.000 claims description 3
- 235000016257 Mentha pulegium Nutrition 0.000 claims description 2
- 244000246386 Mentha pulegium Species 0.000 claims description 2
- 235000004357 Mentha x piperita Nutrition 0.000 claims description 2
- 235000001050 hortel pimenta Nutrition 0.000 claims description 2
- 239000011361 granulated particle Substances 0.000 claims 1
- 239000002253 acid Substances 0.000 abstract description 23
- 229940079593 drug Drugs 0.000 abstract description 11
- 230000008569 process Effects 0.000 abstract description 9
- 238000009478 high shear granulation Methods 0.000 abstract description 2
- 238000011031 large-scale manufacturing process Methods 0.000 abstract description 2
- PWZFXELTLAQOKC-UHFFFAOYSA-A dialuminum;hexamagnesium;carbonate;hexadecahydroxide;tetrahydrate Chemical compound O.O.O.O.[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 PWZFXELTLAQOKC-UHFFFAOYSA-A 0.000 description 26
- 239000000843 powder Substances 0.000 description 12
- 239000000126 substance Substances 0.000 description 12
- 230000000694 effects Effects 0.000 description 9
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical class [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 description 7
- 229940069428 antacid Drugs 0.000 description 7
- 239000003159 antacid agent Substances 0.000 description 7
- 230000001458 anti-acid effect Effects 0.000 description 7
- 210000001156 gastric mucosa Anatomy 0.000 description 6
- 238000004519 manufacturing process Methods 0.000 description 6
- 229940099112 cornstarch Drugs 0.000 description 5
- 239000003795 chemical substances by application Substances 0.000 description 4
- 230000000052 comparative effect Effects 0.000 description 4
- 238000001514 detection method Methods 0.000 description 4
- 238000009472 formulation Methods 0.000 description 4
- 239000000203 mixture Substances 0.000 description 4
- 239000008194 pharmaceutical composition Substances 0.000 description 4
- 235000006679 Mentha X verticillata Nutrition 0.000 description 3
- 235000002899 Mentha suaveolens Nutrition 0.000 description 3
- 235000001636 Mentha x rotundifolia Nutrition 0.000 description 3
- 102000057297 Pepsin A Human genes 0.000 description 3
- 108090000284 Pepsin A Proteins 0.000 description 3
- 239000003205 fragrance Substances 0.000 description 3
- 210000004211 gastric acid Anatomy 0.000 description 3
- 229940111202 pepsin Drugs 0.000 description 3
- 208000007882 Gastritis Diseases 0.000 description 2
- 230000009286 beneficial effect Effects 0.000 description 2
- 230000006378 damage Effects 0.000 description 2
- 201000006549 dyspepsia Diseases 0.000 description 2
- HCRBXQFHJMCTLF-ZCFIWIBFSA-N ethyl (2r)-2-methylbutanoate Chemical compound CCOC(=O)[C@H](C)CC HCRBXQFHJMCTLF-ZCFIWIBFSA-N 0.000 description 2
- 239000000945 filler Substances 0.000 description 2
- 235000013373 food additive Nutrition 0.000 description 2
- 239000002778 food additive Substances 0.000 description 2
- 208000024798 heartburn Diseases 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- -1 magnesium aluminate Chemical class 0.000 description 2
- 150000002894 organic compounds Chemical class 0.000 description 2
- 239000000546 pharmaceutical excipient Substances 0.000 description 2
- 235000019605 sweet taste sensations Nutrition 0.000 description 2
- HSINOMROUCMIEA-FGVHQWLLSA-N (2s,4r)-4-[(3r,5s,6r,7r,8s,9s,10s,13r,14s,17r)-6-ethyl-3,7-dihydroxy-10,13-dimethyl-2,3,4,5,6,7,8,9,11,12,14,15,16,17-tetradecahydro-1h-cyclopenta[a]phenanthren-17-yl]-2-methylpentanoic acid Chemical compound C([C@@]12C)C[C@@H](O)C[C@H]1[C@@H](CC)[C@@H](O)[C@@H]1[C@@H]2CC[C@]2(C)[C@@H]([C@H](C)C[C@H](C)C(O)=O)CC[C@H]21 HSINOMROUCMIEA-FGVHQWLLSA-N 0.000 description 1
- RYCNUMLMNKHWPZ-SNVBAGLBSA-N 1-acetyl-sn-glycero-3-phosphocholine Chemical compound CC(=O)OC[C@@H](O)COP([O-])(=O)OCC[N+](C)(C)C RYCNUMLMNKHWPZ-SNVBAGLBSA-N 0.000 description 1
- HNAGHMKIPMKKBB-UHFFFAOYSA-N 1-benzylpyrrolidine-3-carboxamide Chemical compound C1C(C(=O)N)CCN1CC1=CC=CC=C1 HNAGHMKIPMKKBB-UHFFFAOYSA-N 0.000 description 1
- 206010000060 Abdominal distension Diseases 0.000 description 1
- 102000009024 Epidermal Growth Factor Human genes 0.000 description 1
- 101800003838 Epidermal growth factor Proteins 0.000 description 1
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 1
- 206010020601 Hyperchlorhydria Diseases 0.000 description 1
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 1
- 229920000168 Microcrystalline cellulose Polymers 0.000 description 1
- 206010028813 Nausea Diseases 0.000 description 1
- 208000008469 Peptic Ulcer Diseases 0.000 description 1
- 206010067171 Regurgitation Diseases 0.000 description 1
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 description 1
- 229920002472 Starch Polymers 0.000 description 1
- 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 description 1
- 229930006000 Sucrose Natural products 0.000 description 1
- 208000025865 Ulcer Diseases 0.000 description 1
- 206010047700 Vomiting Diseases 0.000 description 1
- 208000027418 Wounds and injury Diseases 0.000 description 1
- 206010000059 abdominal discomfort Diseases 0.000 description 1
- 208000019790 abdominal distention Diseases 0.000 description 1
- 230000001154 acute effect Effects 0.000 description 1
- 150000001298 alcohols Chemical class 0.000 description 1
- 150000001299 aldehydes Chemical class 0.000 description 1
- WQZGKKKJIJFFOK-PHYPRBDBSA-N alpha-D-galactose Chemical compound OC[C@H]1O[C@H](O)[C@H](O)[C@@H](O)[C@H]1O WQZGKKKJIJFFOK-PHYPRBDBSA-N 0.000 description 1
- 150000001450 anions Chemical class 0.000 description 1
- 229940124350 antibacterial drug Drugs 0.000 description 1
- 239000000739 antihistaminic agent Substances 0.000 description 1
- 229940125715 antihistaminic agent Drugs 0.000 description 1
- 239000002246 antineoplastic agent Substances 0.000 description 1
- 229940041181 antineoplastic drug Drugs 0.000 description 1
- 238000000889 atomisation Methods 0.000 description 1
- 235000008452 baby food Nutrition 0.000 description 1
- 230000004888 barrier function Effects 0.000 description 1
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 description 1
- 239000003613 bile acid Substances 0.000 description 1
- 239000011230 binding agent Substances 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- OBNCKNCVKJNDBV-UHFFFAOYSA-N butanoic acid ethyl ester Natural products CCCC(=O)OCC OBNCKNCVKJNDBV-UHFFFAOYSA-N 0.000 description 1
- 125000002057 carboxymethyl group Chemical group [H]OC(=O)C([H])([H])[*] 0.000 description 1
- 208000023652 chronic gastritis Diseases 0.000 description 1
- 235000009508 confectionery Nutrition 0.000 description 1
- 239000002826 coolant Substances 0.000 description 1
- 239000013078 crystal Substances 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- XEYBRNLFEZDVAW-ARSRFYASSA-N dinoprostone Chemical compound CCCCC[C@H](O)\C=C\[C@H]1[C@H](O)CC(=O)[C@@H]1C\C=C/CCCC(O)=O XEYBRNLFEZDVAW-ARSRFYASSA-N 0.000 description 1
- 229960002986 dinoprostone Drugs 0.000 description 1
- 238000007907 direct compression Methods 0.000 description 1
- 150000002016 disaccharides Chemical class 0.000 description 1
- 238000010494 dissociation reaction Methods 0.000 description 1
- 230000005593 dissociations Effects 0.000 description 1
- 229940116977 epidermal growth factor Drugs 0.000 description 1
- 150000002148 esters Chemical class 0.000 description 1
- 239000001813 ethyl (2R)-2-methylbutanoate Substances 0.000 description 1
- 229940090910 ethyl 2-methylbutyrate Drugs 0.000 description 1
- 235000019634 flavors Nutrition 0.000 description 1
- 229930182830 galactose Natural products 0.000 description 1
- 210000004051 gastric juice Anatomy 0.000 description 1
- 208000021302 gastroesophageal reflux disease Diseases 0.000 description 1
- 239000008103 glucose Substances 0.000 description 1
- 238000005469 granulation Methods 0.000 description 1
- 230000003179 granulation Effects 0.000 description 1
- 238000000227 grinding Methods 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- 230000002209 hydrophobic effect Effects 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
- 208000014674 injury Diseases 0.000 description 1
- 230000002045 lasting effect Effects 0.000 description 1
- 235000019813 microcrystalline cellulose Nutrition 0.000 description 1
- 239000008108 microcrystalline cellulose Substances 0.000 description 1
- 229940016286 microcrystalline cellulose Drugs 0.000 description 1
- 239000008368 mint flavor Substances 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 210000003097 mucus Anatomy 0.000 description 1
- 230000008693 nausea Effects 0.000 description 1
- 230000003472 neutralizing effect Effects 0.000 description 1
- 230000020477 pH reduction Effects 0.000 description 1
- 208000000689 peptic esophagitis Diseases 0.000 description 1
- 208000011906 peptic ulcer disease Diseases 0.000 description 1
- 230000000144 pharmacologic effect Effects 0.000 description 1
- 150000003904 phospholipids Chemical class 0.000 description 1
- 239000004597 plastic additive Substances 0.000 description 1
- 238000003825 pressing Methods 0.000 description 1
- XEYBRNLFEZDVAW-UHFFFAOYSA-N prostaglandin E2 Natural products CCCCCC(O)C=CC1C(O)CC(=O)C1CC=CCCCC(O)=O XEYBRNLFEZDVAW-UHFFFAOYSA-N 0.000 description 1
- 230000002940 repellent Effects 0.000 description 1
- 239000005871 repellent Substances 0.000 description 1
- 238000001223 reverse osmosis Methods 0.000 description 1
- CVHZOJJKTDOEJC-UHFFFAOYSA-N saccharin Chemical compound C1=CC=C2C(=O)NS(=O)(=O)C2=C1 CVHZOJJKTDOEJC-UHFFFAOYSA-N 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- 239000008107 starch Substances 0.000 description 1
- 235000019698 starch Nutrition 0.000 description 1
- 230000003637 steroidlike Effects 0.000 description 1
- 239000005720 sucrose Substances 0.000 description 1
- 150000005846 sugar alcohols Chemical class 0.000 description 1
- 239000000375 suspending agent Substances 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
- 238000003786 synthesis reaction Methods 0.000 description 1
- 150000004685 tetrahydrates Chemical class 0.000 description 1
- 239000002562 thickening agent Substances 0.000 description 1
- 231100000397 ulcer Toxicity 0.000 description 1
- VBEQCZHXXJYVRD-GACYYNSASA-N uroanthelone Chemical compound C([C@@H](C(=O)N[C@H](C(=O)N[C@@H](CS)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CS)C(=O)N[C@H](C(=O)N[C@@H]([C@@H](C)CC)C(=O)NCC(=O)N[C@@H](CC=1C=CC(O)=CC=1)C(=O)N[C@@H](CO)C(=O)NCC(=O)N[C@@H](CC(O)=O)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CS)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CC(O)=O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCNC(N)=N)C(O)=O)C(C)C)[C@@H](C)O)NC(=O)[C@H](CO)NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CO)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@@H](NC(=O)[C@H](CC=1NC=NC=1)NC(=O)[C@H](CCSC)NC(=O)[C@H](CS)NC(=O)[C@@H](NC(=O)CNC(=O)CNC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CS)NC(=O)[C@H](CC=1C=CC(O)=CC=1)NC(=O)CNC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CC=1C=CC(O)=CC=1)NC(=O)[C@H](CO)NC(=O)[C@H](CO)NC(=O)[C@H]1N(CCC1)C(=O)[C@H](CS)NC(=O)CNC(=O)[C@H]1N(CCC1)C(=O)[C@H](CC=1C=CC(O)=CC=1)NC(=O)[C@H](CO)NC(=O)[C@@H](N)CC(N)=O)C(C)C)[C@@H](C)CC)C1=CC=C(O)C=C1 VBEQCZHXXJYVRD-GACYYNSASA-N 0.000 description 1
- 239000011782 vitamin Substances 0.000 description 1
- 229940088594 vitamin Drugs 0.000 description 1
- 229930003231 vitamin Natural products 0.000 description 1
- 235000013343 vitamin Nutrition 0.000 description 1
Abstract
The invention provides a hydrotalcite chewable tablet and a preparation method thereof, the method provided by the invention prepares micronized hydrotalcite bulk drug and diluent into granules by a high-shear wet granulation process, and prepares tablets after mixing the obtained granules with lubricant and flavoring agent to obtain the hydrotalcite chewable tablet; the invention can improve the acid making speed of the hydrotalcite chewable tablet and improve the product quality; the hydrotalcite chewable tablet with good taste is obtained by matching with a prescription and a granulating process, so that the compliance of a patient is enhanced; the product obtained by the invention has stable quality, and the preparation method is suitable for large-scale production.
Description
Technical Field
The invention relates to the technical field of medicinal preparations, in particular to an aluminum magnesium carbonate chewable tablet and a preparation method thereof.
Background
Magnesium aluminocarbonate (Hydrotalcite), chemical name: basic magnesium aluminocarbonate tetrahydrate, molecular formula: al (Al)2Mg6(OH)16CO3·4H2O。
The chemical formula is as follows:
the hydrotalcite chewable tablet is suitable for acute and chronic gastritis, reflux esophagitis, peptic ulcer, heartburn and stomach discomfort related to gastric acid, can relieve symptoms such as heartburn, acid regurgitation, nausea, emesis and abdominal distention caused by hyperchlorhydria, and can prevent gastric mucosa injury of non-steroidal drugs.
The hydrotalcite chewable tablet belongs to antacid drugs, and when the quality of the drugs is evaluated, the antacid capacity index of the drugs not only comprises the acid making capacity item in pharmacopeia standard, but also needs to be examined for the acid making speed; at present, chewable tablets prepared by using domestic magnesium aluminate bulk drugs have the phenomenon of slow acid preparation speed to different degrees, and the quality is inferior to that of the originally ground product; in addition to this, the taste of chewable tablets is an important item to be focused on in order to improve patient compliance, and various solutions have been developed to address the above problems.
The Chinese patent CN200710093165.8 micronizes the hydrotalcite raw material and mannitol, the preparation process is firstly granulated by a high-shear wet method and then granulated by one step, the process is complex, the consumed time is long, the preparation is not suitable for large-scale flow line production, the preparation has the effect taking time of 10min, and the effect taking time is still long.
The Chinese patent CN201010584531.1 adopts a powder direct pressing process, and combines microcrystalline cellulose and crosslinked carboxymethyl starch sodium as a disintegrating agent, so that the acid making speed can be increased, but the improvement effect on the acid making speed is not stable.
The Chinese patent CN201210001044.7 uses micronized bulk drug to increase the disintegration speed by adding sodium dodecyl sulfate in the prescription, but the tablet prepared by the proposal can generate gas in the acid making process and can aggravate abdominal distension.
Chinese patent CN201610610562.7 adopts a wet granulation tabletting process to prepare the hydrotalcite chewable tablet, and does not pay attention to the acid making speed of the product.
The Chinese patent CN201811603597.3 adopts a direct powder tabletting process to prepare the hydrotalcite chewable tablet, only pays attention to the acidity and taste of the product, and does not pay attention to the acidity preparation speed of the product.
Chinese patents CN201810022721.0 and CN202010321155.0 improve the disintegration rate by selecting and proportioning the filler and the disintegrating agent, thereby improving the acid making rate, but the taste is still not ideal.
Based on the problems in the prior art, the hydrotalcite chewable tablet which has high acidification speed, stable quality and good taste and is suitable for industrial mass production and the preparation process thereof need to be developed.
Disclosure of Invention
The invention aims to overcome the defects in the prior art and provides a hydrotalcite chewable tablet and a preparation method thereof.
The invention is realized by the following technical scheme: a hydrotalcite chewable tablet comprises the following raw materials: micronized hydrotalcite, diluent, lubricant and flavoring agent.
Preferably, the raw materials are in the following ratio: 50% of micronized hydrotalcite, 47.5-49.5% of diluent, 0.5-2.0% of lubricant and 0-0.5% of flavoring agent.
Preferably, the treatment method of the micronized hydrotalcite comprises the following steps: the particle diameter D of the crushed raw material medicine is obtained by adopting a jet mill through crushing equipment90The thickness is controlled to be 15-10 μm.
Preferably, the diluent is one or the combination of more than two of mannitol, lactose and corn starch.
Preferably, the lubricant is one of magnesium stearate or calcium stearate.
Preferably, the flavoring agent is one or a combination of more than two of saccharin sodium, mint essence and orange essence.
A preparation method of a hydrotalcite chewable tablet comprises the following steps:
(1) the raw materials are weighed according to the proportion of 50 percent of micronized hydrotalcite, 47.5 to 49.5 percent of diluent, 0.5 to 2.0 percent of lubricant and 0 to 0.5 percent of flavoring agent.
(2) Premixing: and (2) putting the magnesium aluminocarbonate subjected to micronization in the step (1) and a diluent into a high-shear wet-process granulator for mixing.
(3) And (3) granulating: preparing the raw material prepared in step (2) into wet granules by a high shear wet granulator using purified water as a wetting agent.
(4) Wet granulation: and (4) granulating the wet granules obtained in the step (3) by using a swinging granulator.
(5) And (3) drying: and (3) drying the wet-sized particles obtained in the step (4) by using a fluidized bed, wherein the drying air inlet temperature is 50-70 ℃.
(6) Dry granulation: and (5) finishing the dried granules obtained in the step (5) by using a swing granulator.
(7) Total mixing: and (3) putting the granules obtained in the step (6) and the lubricant and the flavoring agent weighed in the step (1) into a multidirectional motion mixer for mixing.
(8) Tabletting: and (4) preparing tablets from the mixed raw materials obtained in the step (7) by using a high-speed tabletting machine.
Preferably, the premixing time in the step (2) is 5-15 minutes, and the total mixing time in the step (7) is 5-10 minutes.
Preferably, the purified water in step (3) is added by atomization.
Preferably, the mesh number of the wet whole grain sieve used in the step (4) is 10 to 20 meshes, and the mesh number of the dry whole grain sieve used in the step (6) is 14 to 24 meshes.
The functions and characteristics of the raw materials in the technical scheme are as follows:
aluminum magnesium carbonate: powder; the pharmacological effects include: neutralizing gastric acid: the product can maintain the pH value of gastric juice between 3 and 5, neutralize 99 percent of gastric acid, inactivate 80 percent of pepsin and has rapid, mild and lasting antacid effect; protecting gastric mucosa: the product can increase synthesis of prostaglandin E2, enhance barrier function of gastric mucosa, promote release of epidermal growth factor in gastric mucosa, increase content of phospholipid in hydrophobic layer of lower layer of mucus, and prevent gastric mucosa damage caused by H + reverse osmosis; ③ the product can absorb and bind pepsin, directly inhibit the activity of pepsin, is beneficial to the restoration of ulcer surfaces, and can also bind bile acid and absorb lysophosphatidylcholine to prevent the substances from damaging and destroying gastric mucosa.
Mannitol: has a chemical formula of C6H14O6Is a sugar alcohol; is easily soluble in water, is white crystalline powder, and has sweet taste similar to sucrose; as excipient for tablet, mannitol has no hygroscopicity, quick drying, good chemical stability, good taste, and good granulation propertyAnd the like, and is used for most of tablets such as anticancer drugs, antibacterial drugs, antihistamines, vitamins and the like. In addition, it is also used for chewable tablets such as sobering drugs and mouth coolants.
Lactose: has a chemical formula of C12H22O11Is disaccharide composed of glucose and galactose, white crystal or crystalline powder; is mainly used for preparing infant food and preparing medicines, such as tablets and medicinal powder, and is used as diluent.
Corn starch: also known as cornstarch, is an important excipient of medicines, and corn starch is mostly used as a filler and a binder in tablets produced by pharmaceutical factories in various countries in the early days.
Magnesium stearate: has a chemical formula of C36H70MgO4Is an organic compound, which is white non-gritty fine powder; mainly used as lubricant, anti-sticking agent and glidant; can be used as glidant in direct compression, filter aid, clarifier and foam-dropping agent, and suspending agent and thickening agent for liquid preparation.
Calcium stearate: is an organic compound with a molecular formula of C36H70CaO4White powder, insoluble in water, can be used as a water repellent, a lubricant, a plastic additive and the like.
Sodium saccharin: has a chemical formula of C7H5NO3SNa is an organic chemical synthetic product and is a food additive; in sweetness, the anion decomposed from saccharin sodium has strong sweetness, but has no sweetness in molecular state; the saccharin sodium has high solubility and dissociation degree, so the saccharin sodium has strong sweet taste.
Mint essence: oily liquid with mint characteristic fragrance is a food additive; has pure mint flavor, strong cool feeling, fresh and clear aroma and is refreshing.
Orange essence: is an essence which mainly imitates the fragrance characteristic of orange pulp. The key components for forming the orange fragrance are aldehydes, alcohols and esters; wherein the trace components for generating the fresh and sweet fruity flavor are ethyl butyrate, ethyl 2-methylbutyrate, sinenseal and the like.
The invention has the beneficial effects that: the method provided by the invention adopts a high-shear wet granulation process, the magnesium aluminum carbonate bulk drug subjected to micronization and a diluent are prepared into granules, and the obtained granules are mixed with a lubricant and a flavoring agent to prepare tablets so as to obtain the magnesium aluminum carbonate chewable tablets; the invention can improve the acid making speed of the hydrotalcite chewable tablet and improve the product quality; the hydrotalcite chewable tablet with good taste is obtained by matching with a prescription and a granulating process, so that the compliance of a patient is enhanced; the product obtained by the invention has stable quality, and the preparation method is suitable for large-scale production.
Detailed Description
In the description of the present invention, it is also to be noted that, unless explicitly stated or limited otherwise; the specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art.
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all embodiments; all other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
A hydrotalcite chewable tablet comprises the following raw materials: micronized hydrotalcite, diluent, lubricant and flavoring agent.
The treatment method of the micronized hydrotalcite comprises the following steps: the particle diameter D of the crushed raw material medicine is obtained by adopting a jet mill through crushing equipment90The thickness is controlled to be 15-10 μm.
The diluent is one or two or three of mannitol, lactose and corn starch.
The lubricant is one of magnesium stearate or calcium stearate.
The flavoring agent is one or two or three of saccharin sodium, peppermint essence and orange essence.
Examples 1-4 were prepared using the following wet granulation process:
a preparation method of a hydrotalcite chewable tablet comprises the following steps:
(1) the raw materials are weighed according to the proportion of 50 percent of micronized hydrotalcite, 47.5 to 49.5 percent of diluent, 0.5 to 2.0 percent of lubricant and 0 to 0.5 percent of flavoring agent.
(2) Premixing: and (2) putting the magnesium aluminocarbonate subjected to micronization in the step (1) and a diluent into a high-shear wet-process granulator for mixing.
(3) And (3) granulating: preparing the raw material prepared in step (2) into wet granules by a high shear wet granulator using purified water as a wetting agent.
(4) Wet granulation: and (4) granulating the wet granules obtained in the step (3) by using a swinging granulator.
(5) And (3) drying: and (3) drying the wet-sized particles obtained in the step (4) by using a fluidized bed, wherein the drying air inlet temperature is 50-70 ℃.
(6) Dry granulation: and (5) finishing the dried granules obtained in the step (5) by using a swing granulator.
(7) Total mixing: and (3) putting the granules obtained in the step (6) and the lubricant and the flavoring agent weighed in the step (1) into a multidirectional motion mixer for mixing.
(8) Tabletting: and (4) preparing tablets from the mixed raw materials obtained in the step (7) by using a high-speed tabletting machine.
The premixing time in the step (2) is 5-15 minutes, and the total mixing time in the step (7) is 5-10 minutes.
The purified water in the step (3) is added in an atomized manner.
The mesh number of the wet whole grain screen used in the step (4) is 10-20 meshes, and the mesh number of the dry whole grain screen used in the step (6) is 14-24 meshes.
Example 1
The formulation is shown in table 1:
table 1:
in the preparation process, the crushing degree of the hydrotalcite raw material used in the step (1) is below 10 mu m; in the step (2), the premixing time is 5 min; in the step (4), the mesh number of the wet whole grain screen is 16 meshes; in the step (5), the air inlet temperature of the fluidized bed is 60 ℃, and in the step (6), the mesh number of the dry whole-grain screen is 18 meshes; in the step (7), the total mixing time is 5 min.
Preparing into granule by the above preparation process, and further preparing into tablet; and (3) detecting the powder chemical properties of the intermediate after the total mixing in the step (7), the acid making capacity and the acid making curve of the tablet, comparing the acid making curve with the Daxi tablet (approval document: Chinese medicine standard H20013410, production enterprise: Bayer medicine health-care Co., Ltd.) of the original product, and obtaining a detection result shown in Table 2.
Table 2:
from the above comparative data, it can be seen that the pharmaceutical formulation prepared according to the present technology can achieve approximately the same antacid effect as the "darxi" tablet under the same conditions.
Example 2
The formulation is shown in table 3:
table 3:
in the preparation process, the crushing degree of the hydrotalcite raw material used in the step (1) is below 15 mu m; in the step (2), the premixing time is 10 min; in the step (4), the mesh number of the wet whole grain screen is 10 meshes; in the step (5), the air inlet temperature of the fluidized bed is 70 ℃; in the step (6), the mesh number of the dry whole granule screen is 16 meshes; in the step (7), the total mixing time is 5 min.
Preparing into granule by the above preparation process, and further preparing into tablet; and (3) detecting the powder chemical properties of the intermediate after the total mixing in the step (7), the acid making capacity and the acid making curve of the tablet, comparing the acid making curve with the Daxi tablet (approval document: Chinese medicine standard H20013410, production enterprise: Bayer medicine health-care Co., Ltd.) of the original product, and obtaining a detection result shown in Table 4.
Table 4:
from the above comparative data, it can be seen that the pharmaceutical formulation prepared according to the present technology can achieve approximately the same antacid effect as the "darxi" tablet under the same conditions.
Example 3
The formulation is shown in table 5:
table 5:
in the preparation process, the crushing degree of the hydrotalcite raw material used in the step (1) is below 12 mu m; in the step (2), the premixing time is 10 min; in the step (4), the mesh number of the wet whole grain screen is 16 meshes; in the step (5), the air inlet temperature of the fluidized bed is 60 ℃; in the step (6), the mesh number of the dry whole grain sieve is 20 meshes; in the step (7), the total mixing time is 8 min.
Preparing into granule by the above preparation process, and further preparing into tablet; and (3) detecting the powder chemical properties of the intermediate after the total mixing in the step (7), the acid making capacity and the acid making curve of the tablet, comparing the acid making curve with the Daxi tablet (approval document: Chinese medicine standard H20013410, production enterprise: Bayer medicine health-care Co., Ltd.) of the original product, and obtaining a detection result shown in Table 6.
Table 6:
from the above comparative data, it can be seen that the pharmaceutical formulation prepared according to the present technology can achieve approximately the same antacid effect as the "darxi" tablet under the same conditions.
Example 4
The formulation is shown in table 7:
table 7:
in the preparation process, the crushing degree of the hydrotalcite raw material used in the step (1) is below 10 mu m; in the step (2), the premixing time is 8 min; in the step (5), the mesh number of the wet whole grain screen is 18 meshes; in the step (6), the air inlet temperature of the fluidized bed is 70 ℃; in the step (7), the mesh number of the dry whole grain sieve is 20 meshes; in the step (8), the total mixing time is 5 min.
Preparing into granule by the above preparation process, and further preparing into tablet; the powder properties of the intermediate after the final mixing in the step (7) and the acid making power and acid making curve of the tablet are detected, the acid making curve is compared with the original grinding product Daxi tablet (approval document: Chinese medicine standard H20013410, production enterprise: Bayer medicine health Limited company), and the detection results are shown in Table 8.
Table 8:
from the above comparative data, it can be seen that the pharmaceutical formulation prepared according to the present technology can achieve approximately the same antacid effect as the "darxi" tablet under the same conditions.
Finally, it should be noted that: although the present invention has been described in detail with reference to the foregoing embodiments, it will be apparent to those skilled in the art that modifications may be made to the embodiments or portions thereof without departing from the spirit and scope of the invention.
Claims (9)
1. A hydrotalcite chewable tablet is characterized in that: the raw materials comprise 50 percent of micronized hydrotalcite, 47.5 to 49.5 percent of diluent, 0.5 to 2.0 percent of lubricant and 0 to 0.5 percent of flavoring agent.
2. The hydrotalcite chewable tablet of claim 1, wherein: the treatment method of the micronized hydrotalcite comprises the following steps: the particle diameter D of the crushed raw material medicine is obtained by adopting a jet mill through crushing equipment90The thickness is controlled to be 15-10 μm.
3. The hydrotalcite chewable tablet of claim 1, wherein: the diluent is one or the combination of more than two of mannitol, lactose and corn starch.
4. The hydrotalcite chewable tablet of claim 1, wherein: the lubricant is one of magnesium stearate or calcium stearate.
5. The hydrotalcite chewable tablet of claim 1, wherein: the flavoring agent is one or more of saccharin sodium, peppermint essence and orange essence.
6. A preparation method of a hydrotalcite chewable tablet is characterized in that: comprises the following steps
(1) According to specification D9050 percent of aluminum magnesium carbonate micronized at 15 mu m to 10 mu m, 47.5 to 49.5 percent of diluent, 0.5 to 2.0 percent of lubricant and 0 to 0.5 percent of flavoring agent are weighed according to the proportion;
(2) premixing: putting the magnesium aluminocarbonate subjected to micronization in the step (1) and a diluent into a high-shear wet-process granulator for mixing;
(3) and (3) granulating: preparing the raw materials prepared in the step (2) into wet granules by using purified water as a wetting agent through a high-shear wet granulator;
(4) wet granulation: granulating the wet granules obtained in the step (3) by using a swinging granulator;
(5) and (3) drying: drying the wet and granulated particles obtained in the step (4) by using a fluidized bed, wherein the drying air inlet temperature is 50-70 ℃;
(6) dry granulation: finishing the dried granules obtained in the step (5) by using a swinging granulator;
(7) total mixing: putting the granules obtained in the step (6) and the lubricant and the flavoring agent weighed in the step (1) into a multidirectional motion mixer for mixing;
(8) tabletting: and (4) preparing tablets from the mixed raw materials obtained in the step (7) by using a high-speed tabletting machine.
7. The method for preparing the hydrotalcite chewable tablet according to claim 6, wherein the step of: the premixing time in the step (2) is 5-15 minutes, and the total mixing time in the step (7) is 5-10 minutes.
8. The method for preparing the hydrotalcite chewable tablet according to claim 6, wherein the step of: the purified water in the step (3) is added in an atomized manner.
9. The method for preparing the hydrotalcite chewable tablet according to claim 6, wherein the step of: the mesh number of the wet whole grain screen used in the step (4) is 10-20 meshes, and the mesh number of the dry whole grain screen used in the step (6) is 14-24 meshes.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202110036123.0A CN112675192A (en) | 2021-01-12 | 2021-01-12 | Hydrotalcite chewable tablet and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202110036123.0A CN112675192A (en) | 2021-01-12 | 2021-01-12 | Hydrotalcite chewable tablet and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN112675192A true CN112675192A (en) | 2021-04-20 |
Family
ID=75457574
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202110036123.0A Pending CN112675192A (en) | 2021-01-12 | 2021-01-12 | Hydrotalcite chewable tablet and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN112675192A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114699427A (en) * | 2022-04-12 | 2022-07-05 | 广西南宁百会药业集团有限公司 | Hydrotalcite chewable tablet and preparation method thereof |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4447417A (en) * | 1978-02-17 | 1984-05-08 | Anphar S.A. | Basic aluminium magnesium carbonate |
| CN101219150A (en) * | 2007-12-19 | 2008-07-16 | 游洪涛 | Rapidly effectual aluminum magnesium carbonate preparation and technique of preparing the same |
| CN102813634A (en) * | 2012-01-04 | 2012-12-12 | 重庆华森制药有限公司 | Hydrotalcite tablet and its preparation method |
| CN106214647A (en) * | 2016-07-29 | 2016-12-14 | 花园药业股份有限公司 | Bangxiaoan and preparation technology thereof |
-
2021
- 2021-01-12 CN CN202110036123.0A patent/CN112675192A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4447417A (en) * | 1978-02-17 | 1984-05-08 | Anphar S.A. | Basic aluminium magnesium carbonate |
| CN101219150A (en) * | 2007-12-19 | 2008-07-16 | 游洪涛 | Rapidly effectual aluminum magnesium carbonate preparation and technique of preparing the same |
| CN102813634A (en) * | 2012-01-04 | 2012-12-12 | 重庆华森制药有限公司 | Hydrotalcite tablet and its preparation method |
| CN106214647A (en) * | 2016-07-29 | 2016-12-14 | 花园药业股份有限公司 | Bangxiaoan and preparation technology thereof |
Non-Patent Citations (2)
| Title |
|---|
| 周长征 辛义周主编: "《制药工程原理与设备》", 31 August 2008, 山东科学技术出版社 * |
| 赵宁等: "铝碳酸镁咀嚼片的处方及制剂工艺研究", 《应用化工》 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114699427A (en) * | 2022-04-12 | 2022-07-05 | 广西南宁百会药业集团有限公司 | Hydrotalcite chewable tablet and preparation method thereof |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| US8153157B2 (en) | Porous cellulose aggregate and molding composition thereof | |
| AU2004242688B2 (en) | Cellulose powder | |
| KR100802645B1 (en) | Calcium metasilicates and methods for making the same | |
| CN101374503B (en) | Quickly disintegrating tablet produced by direct dry-tabletting | |
| NO331462B1 (en) | Process for the preparation of an orally administrable calcium composition in tablet form | |
| WO2005037319A1 (en) | Composition for tablet rapidly disintegrable in mouth | |
| KR20080080197A (en) | Pharmaceutical formulation for producing rapidly disintegrating tablets | |
| EP1097722A1 (en) | Excipient | |
| CN100546571C (en) | Sangju effervescent tablet for treating common cold | |
| CN100556401C (en) | Effervescence tablet for cold | |
| CN112675192A (en) | Hydrotalcite chewable tablet and preparation method thereof | |
| CN1935120B (en) | Effervescent dry-mixed suspension agent | |
| RU2519768C2 (en) | Directly pressible and rapidly-decomposable tablet matrix | |
| CN102526748B (en) | Oral tablet containing Valsartan, Hydrochioro and Amlodipine Besylate Tablet | |
| CA2748496C (en) | Disintegrable formulations of lanthanum carbonate | |
| CN108078937A (en) | A kind of hydrotalcite tablet and preparation method thereof | |
| CN108992480A (en) | Honeysuckle chrysanthemum effervescent tablets and preparation method thereof | |
| CN111617042A (en) | Composite calcium carbonate vitamin D3Water-free swallow granule and preparation method thereof | |
| CN111481568B (en) | Hydrotalcite tablet and preparation process thereof | |
| CN1957938B (en) | Effervescence tablet of Glucurolactone, and preparation method | |
| CN102670533B (en) | Aripiprazole orally disintegrating tablet of stabilization and preparation method thereof | |
| CN101297869A (en) | Gastralgia dispersed tablet and preparation | |
| CN100546570C (en) | Effervescence tablet for treating wind-cold type cold | |
| CN110200935A (en) | A kind of Couoidal bismuth pectin capsules and its preparation process | |
| JP2003501484A (en) | Filler binder for tablets |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| RJ01 | Rejection of invention patent application after publication | ||
| RJ01 | Rejection of invention patent application after publication |
Application publication date: 20210420 |