CN111388436A - 一种海藻酸钠咀嚼片及其制备方法 - Google Patents
一种海藻酸钠咀嚼片及其制备方法 Download PDFInfo
- Publication number
- CN111388436A CN111388436A CN202010315849.3A CN202010315849A CN111388436A CN 111388436 A CN111388436 A CN 111388436A CN 202010315849 A CN202010315849 A CN 202010315849A CN 111388436 A CN111388436 A CN 111388436A
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- CN
- China
- Prior art keywords
- parts
- sodium alginate
- chewable tablet
- magnesium
- weight
- 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
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- IXPNQXFRVYWDDI-UHFFFAOYSA-N 1-methyl-2,4-dioxo-1,3-diazinane-5-carboximidamide Chemical compound CN1CC(C(N)=N)C(=O)NC1=O IXPNQXFRVYWDDI-UHFFFAOYSA-N 0.000 title claims abstract description 56
- 239000000661 sodium alginate Substances 0.000 title claims abstract description 56
- 235000010413 sodium alginate Nutrition 0.000 title claims abstract description 56
- 229940005550 sodium alginate Drugs 0.000 title claims abstract description 56
- 239000007910 chewable tablet Substances 0.000 title claims abstract description 45
- 229940068682 chewable tablet Drugs 0.000 title claims abstract description 41
- 238000002360 preparation method Methods 0.000 title claims abstract description 21
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 claims abstract description 38
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims abstract description 36
- 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 32
- 239000003814 drug Substances 0.000 claims abstract description 26
- 239000000395 magnesium oxide Substances 0.000 claims abstract description 21
- CPLXHLVBOLITMK-UHFFFAOYSA-N magnesium oxide Inorganic materials [Mg]=O CPLXHLVBOLITMK-UHFFFAOYSA-N 0.000 claims abstract description 21
- AXZKOIWUVFPNLO-UHFFFAOYSA-N magnesium;oxygen(2-) Chemical compound [O-2].[Mg+2] AXZKOIWUVFPNLO-UHFFFAOYSA-N 0.000 claims abstract description 21
- 229910000019 calcium carbonate Inorganic materials 0.000 claims abstract description 19
- 108010011485 Aspartame Proteins 0.000 claims abstract description 18
- TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 claims abstract description 18
- 239000000605 aspartame Substances 0.000 claims abstract description 18
- 235000010357 aspartame Nutrition 0.000 claims abstract description 18
- IAOZJIPTCAWIRG-QWRGUYRKSA-N aspartame Chemical compound OC(=O)C[C@H](N)C(=O)N[C@H](C(=O)OC)CC1=CC=CC=C1 IAOZJIPTCAWIRG-QWRGUYRKSA-N 0.000 claims abstract description 18
- 229960003438 aspartame Drugs 0.000 claims abstract description 18
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims abstract description 18
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims abstract description 18
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims abstract description 18
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims abstract description 18
- 235000019359 magnesium stearate Nutrition 0.000 claims abstract description 18
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 claims abstract description 18
- 239000000811 xylitol Substances 0.000 claims abstract description 18
- 235000010447 xylitol Nutrition 0.000 claims abstract description 18
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 claims abstract description 18
- 229960002675 xylitol Drugs 0.000 claims abstract description 18
- 235000010355 mannitol Nutrition 0.000 claims abstract description 16
- 235000006679 Mentha X verticillata Nutrition 0.000 claims abstract description 15
- 235000002899 Mentha suaveolens Nutrition 0.000 claims abstract description 15
- 235000001636 Mentha x rotundifolia Nutrition 0.000 claims abstract description 15
- 239000002202 Polyethylene glycol Substances 0.000 claims abstract description 15
- UIIMBOGNXHQVGW-DEQYMQKBSA-M Sodium bicarbonate-14C Chemical compound [Na+].O[14C]([O-])=O UIIMBOGNXHQVGW-DEQYMQKBSA-M 0.000 claims abstract description 15
- 229920001223 polyethylene glycol Polymers 0.000 claims abstract description 15
- HCHKCACWOHOZIP-UHFFFAOYSA-N Zinc Chemical compound [Zn] HCHKCACWOHOZIP-UHFFFAOYSA-N 0.000 claims abstract description 14
- 239000011701 zinc Substances 0.000 claims abstract description 14
- 229910052725 zinc Inorganic materials 0.000 claims abstract description 14
- WBZFUFAFFUEMEI-UHFFFAOYSA-M Acesulfame k Chemical compound [K+].CC1=CC(=O)[N-]S(=O)(=O)O1 WBZFUFAFFUEMEI-UHFFFAOYSA-M 0.000 claims abstract description 12
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 claims abstract description 12
- 235000010358 acesulfame potassium Nutrition 0.000 claims abstract description 12
- 229960004998 acesulfame potassium Drugs 0.000 claims abstract description 12
- 239000000619 acesulfame-K Substances 0.000 claims abstract description 12
- 239000011575 calcium Substances 0.000 claims abstract description 12
- 229910052791 calcium Inorganic materials 0.000 claims abstract description 12
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 claims abstract description 11
- 239000011777 magnesium Substances 0.000 claims abstract description 11
- 229910052749 magnesium Inorganic materials 0.000 claims abstract description 11
- 239000002366 mineral element Substances 0.000 claims abstract description 8
- 239000008187 granular material Substances 0.000 claims description 15
- 238000002156 mixing Methods 0.000 claims description 15
- WHMDKBIGKVEYHS-IYEMJOQQSA-L Zinc gluconate Chemical compound [Zn+2].OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C([O-])=O.OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C([O-])=O WHMDKBIGKVEYHS-IYEMJOQQSA-L 0.000 claims description 14
- 208000021302 gastroesophageal reflux disease Diseases 0.000 claims description 14
- 239000011670 zinc gluconate Substances 0.000 claims description 14
- 235000011478 zinc gluconate Nutrition 0.000 claims description 14
- 229960000306 zinc gluconate Drugs 0.000 claims description 14
- 239000003826 tablet Substances 0.000 claims description 12
- 238000001035 drying Methods 0.000 claims description 10
- 230000001502 supplementing effect Effects 0.000 claims description 9
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 8
- 235000013305 food Nutrition 0.000 claims description 7
- 239000000853 adhesive Substances 0.000 claims description 6
- 230000001070 adhesive effect Effects 0.000 claims description 6
- 238000000034 method Methods 0.000 claims description 6
- 238000005303 weighing Methods 0.000 claims description 6
- 229960005164 acesulfame Drugs 0.000 claims description 5
- YGCFIWIQZPHFLU-UHFFFAOYSA-N acesulfame Chemical compound CC1=CC(=O)NS(=O)(=O)O1 YGCFIWIQZPHFLU-UHFFFAOYSA-N 0.000 claims description 5
- 239000000203 mixture Substances 0.000 claims description 5
- 229940093429 polyethylene glycol 6000 Drugs 0.000 claims description 3
- 239000008213 purified water Substances 0.000 claims description 3
- 239000002994 raw material Substances 0.000 claims description 3
- 238000007873 sieving Methods 0.000 claims description 3
- 239000000594 mannitol Substances 0.000 claims description 2
- 229940079593 drug Drugs 0.000 abstract description 12
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 abstract description 7
- 239000013589 supplement Substances 0.000 abstract description 7
- 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 abstract description 5
- 239000011734 sodium Substances 0.000 abstract description 5
- 229910052708 sodium Inorganic materials 0.000 abstract description 5
- 210000002784 stomach Anatomy 0.000 abstract description 5
- 210000003238 esophagus Anatomy 0.000 abstract description 4
- 238000010992 reflux Methods 0.000 abstract description 3
- 210000001156 gastric mucosa Anatomy 0.000 abstract description 2
- 230000007774 longterm Effects 0.000 abstract description 2
- 208000002193 Pain Diseases 0.000 description 9
- 208000007107 Stomach Ulcer Diseases 0.000 description 9
- 238000012360 testing method Methods 0.000 description 9
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 description 8
- 208000024891 symptom Diseases 0.000 description 8
- 230000000694 effects Effects 0.000 description 7
- 201000005917 gastric ulcer Diseases 0.000 description 7
- 229910052782 aluminium Inorganic materials 0.000 description 5
- 201000010099 disease Diseases 0.000 description 5
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 5
- 210000004211 gastric acid Anatomy 0.000 description 5
- 239000000243 solution Substances 0.000 description 5
- CURLTUGMZLYLDI-UHFFFAOYSA-N Carbon dioxide Chemical compound O=C=O CURLTUGMZLYLDI-UHFFFAOYSA-N 0.000 description 4
- 208000007882 Gastritis Diseases 0.000 description 4
- 206010067171 Regurgitation Diseases 0.000 description 4
- 208000025865 Ulcer Diseases 0.000 description 4
- 239000002253 acid Substances 0.000 description 4
- 230000001684 chronic effect Effects 0.000 description 4
- 235000005911 diet Nutrition 0.000 description 4
- 239000000047 product Substances 0.000 description 4
- 235000017557 sodium bicarbonate Nutrition 0.000 description 4
- 229910000030 sodium bicarbonate Inorganic materials 0.000 description 4
- 231100000397 ulcer Toxicity 0.000 description 4
- 208000027418 Wounds and injury Diseases 0.000 description 3
- 239000007864 aqueous solution Substances 0.000 description 3
- 230000006378 damage Effects 0.000 description 3
- 230000037213 diet Effects 0.000 description 3
- 201000006549 dyspepsia Diseases 0.000 description 3
- 230000007958 sleep Effects 0.000 description 3
- 206010000087 Abdominal pain upper Diseases 0.000 description 2
- BHPQYMZQTOCNFJ-UHFFFAOYSA-N Calcium cation Chemical compound [Ca+2] BHPQYMZQTOCNFJ-UHFFFAOYSA-N 0.000 description 2
- 206010015137 Eructation Diseases 0.000 description 2
- 229910019142 PO4 Inorganic materials 0.000 description 2
- 206010052428 Wound Diseases 0.000 description 2
- 210000001015 abdomen Anatomy 0.000 description 2
- 230000009471 action Effects 0.000 description 2
- UJOHNXQDVUADCG-UHFFFAOYSA-L aluminum;magnesium;carbonate Chemical compound [Mg+2].[Al+3].[O-]C([O-])=O UJOHNXQDVUADCG-UHFFFAOYSA-L 0.000 description 2
- 230000036528 appetite Effects 0.000 description 2
- 235000019789 appetite Nutrition 0.000 description 2
- 208000027687 belching Diseases 0.000 description 2
- 230000036772 blood pressure Effects 0.000 description 2
- 210000000988 bone and bone Anatomy 0.000 description 2
- 239000001569 carbon dioxide Substances 0.000 description 2
- 229910002092 carbon dioxide Inorganic materials 0.000 description 2
- 238000002474 experimental method Methods 0.000 description 2
- 230000002496 gastric effect Effects 0.000 description 2
- 210000001035 gastrointestinal tract Anatomy 0.000 description 2
- 238000002575 gastroscopy Methods 0.000 description 2
- 208000024798 heartburn Diseases 0.000 description 2
- 239000010452 phosphate Substances 0.000 description 2
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 description 2
- 231100000572 poisoning Toxicity 0.000 description 2
- 230000000607 poisoning effect Effects 0.000 description 2
- 230000008569 process Effects 0.000 description 2
- 208000018556 stomach disease Diseases 0.000 description 2
- 239000011573 trace mineral Substances 0.000 description 2
- 235000013619 trace mineral Nutrition 0.000 description 2
- 229940126672 traditional medicines Drugs 0.000 description 2
- 210000002700 urine Anatomy 0.000 description 2
- FHVDTGUDJYJELY-UHFFFAOYSA-N 6-{[2-carboxy-4,5-dihydroxy-6-(phosphanyloxy)oxan-3-yl]oxy}-4,5-dihydroxy-3-phosphanyloxane-2-carboxylic acid Chemical compound O1C(C(O)=O)C(P)C(O)C(O)C1OC1C(C(O)=O)OC(OP)C(O)C1O FHVDTGUDJYJELY-UHFFFAOYSA-N 0.000 description 1
- 206010000060 Abdominal distension Diseases 0.000 description 1
- 206010006956 Calcium deficiency Diseases 0.000 description 1
- 208000019505 Deglutition disease Diseases 0.000 description 1
- 208000020401 Depressive disease Diseases 0.000 description 1
- 206010012735 Diarrhoea Diseases 0.000 description 1
- 239000004277 Ferrous carbonate Substances 0.000 description 1
- 208000012895 Gastric disease Diseases 0.000 description 1
- 208000037147 Hypercalcaemia Diseases 0.000 description 1
- 206010020601 Hyperchlorhydria Diseases 0.000 description 1
- 206010020772 Hypertension Diseases 0.000 description 1
- 208000029663 Hypophosphatemia Diseases 0.000 description 1
- 208000028389 Nerve injury Diseases 0.000 description 1
- OAICVXFJPJFONN-UHFFFAOYSA-N Phosphorus Chemical compound [P] OAICVXFJPJFONN-UHFFFAOYSA-N 0.000 description 1
- 206010048259 Zinc deficiency Diseases 0.000 description 1
- 230000002159 abnormal effect Effects 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 229940072056 alginate Drugs 0.000 description 1
- 235000010443 alginic acid Nutrition 0.000 description 1
- 229920000615 alginic acid Polymers 0.000 description 1
- -1 aluminum ions Chemical class 0.000 description 1
- LCWAOCHOPBSGMU-UHFFFAOYSA-J aluminum;magnesium;sodium;hydrogen carbonate;oxygen(2-);silicon;trihydroxide Chemical compound [OH-].[OH-].[OH-].[O-2].[Na+].[Mg+2].[Al+3].[Si].OC([O-])=O LCWAOCHOPBSGMU-UHFFFAOYSA-J 0.000 description 1
- 229940069428 antacid Drugs 0.000 description 1
- 239000003159 antacid agent Substances 0.000 description 1
- 230000004888 barrier function Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 238000001574 biopsy Methods 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 230000002308 calcification Effects 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 239000003153 chemical reaction reagent Substances 0.000 description 1
- 210000000038 chest Anatomy 0.000 description 1
- 230000001055 chewing effect Effects 0.000 description 1
- 210000003792 cranial nerve Anatomy 0.000 description 1
- 206010061428 decreased appetite Diseases 0.000 description 1
- 238000003745 diagnosis Methods 0.000 description 1
- 230000000378 dietary effect Effects 0.000 description 1
- 230000029087 digestion Effects 0.000 description 1
- 230000000857 drug effect Effects 0.000 description 1
- 208000000718 duodenal ulcer Diseases 0.000 description 1
- 230000029142 excretion Effects 0.000 description 1
- 210000004051 gastric juice Anatomy 0.000 description 1
- 210000003736 gastrointestinal content Anatomy 0.000 description 1
- 239000003292 glue Substances 0.000 description 1
- 230000035876 healing Effects 0.000 description 1
- 208000006750 hematuria Diseases 0.000 description 1
- 230000000148 hypercalcaemia Effects 0.000 description 1
- 208000030915 hypercalcemia disease Diseases 0.000 description 1
- 230000002401 inhibitory effect Effects 0.000 description 1
- 208000014674 injury Diseases 0.000 description 1
- 230000003993 interaction Effects 0.000 description 1
- 230000003907 kidney function Effects 0.000 description 1
- 210000004185 liver Anatomy 0.000 description 1
- 230000003908 liver function Effects 0.000 description 1
- VTHJTEIRLNZDEV-UHFFFAOYSA-L magnesium dihydroxide Chemical compound [OH-].[OH-].[Mg+2] VTHJTEIRLNZDEV-UHFFFAOYSA-L 0.000 description 1
- 239000000347 magnesium hydroxide Substances 0.000 description 1
- 229910001862 magnesium hydroxide Inorganic materials 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 235000012054 meals Nutrition 0.000 description 1
- 201000003102 mental depression Diseases 0.000 description 1
- 230000003340 mental effect Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 210000004400 mucous membrane Anatomy 0.000 description 1
- 230000008764 nerve damage Effects 0.000 description 1
- 230000007935 neutral effect Effects 0.000 description 1
- 238000006386 neutralization reaction Methods 0.000 description 1
- 230000003472 neutralizing effect Effects 0.000 description 1
- 231100000957 no side effect Toxicity 0.000 description 1
- 239000011574 phosphorus Substances 0.000 description 1
- 229910052698 phosphorus Inorganic materials 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 229920006395 saturated elastomer Polymers 0.000 description 1
- 108010048734 sclerotin Proteins 0.000 description 1
- 238000012216 screening Methods 0.000 description 1
- 238000004904 shortening Methods 0.000 description 1
- 235000021023 sodium intake Nutrition 0.000 description 1
- 230000009747 swallowing Effects 0.000 description 1
- 230000035922 thirst Effects 0.000 description 1
- 210000002417 xiphoid bone Anatomy 0.000 description 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/125—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives containing carbohydrate syrups; containing sugars; containing sugar alcohols; containing starch hydrolysates
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/16—Inorganic salts, minerals or trace elements
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23P—SHAPING OR WORKING OF FOODSTUFFS, NOT FULLY COVERED BY A SINGLE OTHER SUBCLASS
- A23P10/00—Shaping or working of foodstuffs characterised by the products
- A23P10/20—Agglomerating; Granulating; Tabletting
- A23P10/28—Tabletting; Making food bars by compression of a dry powdered mixture
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/734—Alginic acid
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- A61K33/24—Heavy metals; Compounds thereof
- A61K33/30—Zinc; Compounds thereof
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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- A—HUMAN NECESSITIES
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- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
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- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
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- A—HUMAN NECESSITIES
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- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
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- A61P3/02—Nutrients, e.g. vitamins, minerals
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
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Abstract
本发明公开了一种海藻酸钠咀嚼片,包括以下重量份组份:包括以下重量份组份:海藻酸钠200‑300、碳酸氢钠50‑300、碳酸钙150‑300、氧化镁30‑300、D‑甘露糖醇50‑300、聚乙二醇6000 50‑200、羟丙基甲基纤维素E50 5‑20、薄荷香精1‑10、安赛蜜1‑3、阿斯巴甜1‑3、木糖醇DC级5‑100、硬脂酸镁5‑20。本申请的海藻酸钠咀嚼片的制备方法简单,制得的咀嚼片不仅能够调节胃食管反流保护胃黏膜,而且可以同时补充矿质元素钙和镁,还可以补充锌元素,适用于多种人群;口服更加方便,便于携带;避免了铝元素的超标以及钠元素的过量服用,可以长期的安全用药。
Description
技术领域
本发明涉及食品及医药技术领域,特别涉及一种海藻酸钠咀嚼片及其制备方法。
背景技术
胃食管反流是指胃食管腔因过度接触(或暴露于)胃液而引起的临床胃食管反流症和食管黏膜损伤的疾病。异常反流引发胃内容物返回食道。胃食管反流及其并发症的发生是多因素的,临床表现为胃灼热和反酸、吞咽疼痛、吞咽困难、反胃等等。对人们的生活质量将会产生重大的影响,比如精神抑郁、睡眠受干扰以及影响身体和社交表现。而且,胃食管反流还能引起胃溃疡等其他疾病。
传统的治疗胃食管反流的药物以碳酸氢钠、碳酸钙等为主,其起效时间快,但是其作用时间短,而缩短用药时间无疑增加了用药频率,对患者的身体其他性能造成影响,得不偿失。在传统药物的基础上,之后研发出海藻酸盐相关一些列的药物,其治疗效果比传统的药物更优,临床上也更加安全,但是其对胃溃疡患者存在较大风险,同时由于钠元素的大量使用容易导致患者体内钠平衡紊乱。
另外市场上常见的治疗胃病的药物,如达喜(主要成分铝碳酸镁片)、胃舒平(主要成分氢氧化铝、三硅酸镁)等,他们的主要成分都含有铝元素。但是这类药物属于非吸收性抗酸药,该药物使用中容易出现腹泻、口渴、食欲不振等等的副作用。同时,药物中含有难吸收的铝离子,口服后只能直接中和胃酸而没有被胃肠道吸收。长期大量服用可在肠道内保留形成不溶性磷铝而沉积下来,并使得磷酸盐从粪便中丢失而导致低磷酸血症,进一步引起骨中钙的渗出丢失,最后引起代磷酸盐尿和高钙质尿,甚至铝中毒。由此可见,为了避免铝中毒及钙流失,患者不宜长期大量服用铝碳酸镁片。
所以,现有的药物虽然可以治疗胃食管反流以及常见的胃病,但是其都存在着安全隐患,无法满足和适用于多种人群。
发明内容
本发明所要解决的技术问题是提供一种海藻酸钠咀嚼片及其制备方法,该咀嚼片既能治疗传统的胃食管反流又能补充人体所需的微量元素,同时无副作用,可以满足和适用于多种人群。
本发明所要解决的技术问题是通过以下技术方案来实现的:
一种海藻酸钠咀嚼片,包括以下重量份组份:海藻酸钠200-300、碳酸氢钠50-300、碳酸钙150-300、氧化镁30-300、D-甘露糖醇50-300、聚乙二醇6000 50-200、羟丙基甲基纤维素E50 5-20、薄荷香精1-10、安赛蜜1-3、阿斯巴甜1-3、木糖醇DC级5-100、硬脂酸镁5-20。
优选地,上述技术方案中,包括以下重量份组份:海藻酸钠225-275、碳酸氢钠120-220、碳酸钙200-250、氧化镁40-170、D-甘露糖醇120-220、聚乙二醇6000 50-100、羟丙基甲基纤维素E50 12-18、薄荷香精3-8、安赛蜜1-3、阿斯巴甜1-3、木糖醇DC级5-50、硬脂酸镁10-15。
优选地,上述技术方案中,包括以下重量份组份:海藻酸钠275、碳酸氢钠133.5、碳酸钙212.5、氧化镁60、D-甘露糖醇200、聚乙二醇6000 60、羟丙基甲基纤维素E50 15、薄荷香精7.5、安赛蜜2、阿斯巴甜2.5、木糖醇DC级10、硬脂酸镁13.5。
优选地,上述技术方案中,所述海藻酸钠咀嚼片还包括以下重量份组份:葡萄糖酸锌5-20。
优选地,上述技术方案中,所述海藻酸钠咀嚼片还包括以下重量份组份:葡萄糖酸锌优选为8.5。
一种海藻酸钠咀嚼片的制备方法,包括以下步骤:
(1)原料称取:按配方量称取各组份,备用;
(2)制粒:
(21)将聚乙二醇6000、羟丙基甲基纤维素加纯化水配制成20%和5%的浓度溶液,作粘合剂备用;
(22)再将配方量海藻酸钠、碳酸氢钠、碳酸钙、D-甘露糖醇、安赛蜜、阿斯巴甜混合均匀,加入粘合剂,30目制粒;
(3)干燥:将制好的湿颗粒在40-80℃下干燥20-60min,控制颗粒水分3%;
(4)整粒:将干燥好的颗粒过20目筛,整粒;
(5)总混:将干燥后的颗粒与氧化镁、薄荷香精、木糖醇混合25min;混合均匀后再加入硬脂酸镁混合5min,得总混物料;
(6)压片:用旋转式压片机进行压片,1.0g/片,定期检查片重差异。
优选地,上述技术方案中,所述步骤(22)的混合物中还包括葡萄糖酸锌。
优选地,上述技术方案中,所述步骤(3)干燥的温度为60℃,干燥时间为30min。
一种海藻酸钠咀嚼片在制备具有治疗胃食管反流和补充矿物元素钙、镁的药品或食品中的应用。
一种海藻酸钠咀嚼片在制备具有治疗胃食管反流和补充矿物元素钙、镁、锌的药品或食品中的应用。
本申请的海藻酸钠咀嚼片与胃酸接触时形成的强烈,粘稠,接近中性(pH值接近于7,即酸碱中和)的屏障(筏),其漂浮在胃内容物上,由二氧化碳气体支撑筏的形成,在严重胃食管反流的情况下,筏会首先回流到食管,不会造成伤害。同时,在形成筏下方的胃部酸碱度不会受到影响,消化过程可以正常进行。
钙促进钠的排出,达到钠平衡,减少钠摄入过多而产生的诸如高血压等疾病的危害。
氧化镁可以对患者进行镁补充,同时中和胃酸。氧化镁与水生成氢氧化镁,呈微碱性反应,饱和水溶液的pH 10.3,该水溶液极易溶于稀酸,极微溶于纯水,因二氧化碳的存在而增加其溶解度。利用这一特性,氧化镁在配方中不仅起到了镁元素的补充作用,最重要的是可以起到中和胃酸、抑制和缓解胃酸过多、治疗胃溃疡和十二指肠溃疡病的作用,而且其中和胃酸作用强劲且持久。同时,配方中的镁能促进钙元素的吸收,可防止骨质的钙化又能起到极强的降血压作用。
锌是人体必需微量元素之一,缺锌会导致皮肤黏膜的生长缓慢,是导致胃溃疡的原因之一。葡萄糖酸锌的作用则是补充锌元素,其补充锌元素的同时又防止了胃溃疡的产生。而且,锌元素能促进胃创伤和胃溃疡的愈合,尤其是用药初期的一段时间内,在锌的作用下溃疡和创伤面积明显缩小,其保护效果明显。同时,本申请添加锌元素,其和钙元素一起解决了常规胃药中铝元素超量引起脑神经损伤并引起骨骼软化和缺钙问题,达到同时补钙和补锌的目的。
本发明上述技术方案,具有如下有益效果:
(1)申请的海藻酸钠咀嚼片的制备方法简单,制备得到的咀嚼片不仅能够调节胃食管反流保护胃黏膜,而且可以同时补充矿质元素钙和镁,还可以补充锌元素,适用于多种人群的需要;
(2)本申请制备得到的咀嚼片口服更加方便,便于携带;
(3)本申请的海藻酸钠咀嚼片避免了铝元素的超标,而且尚未发现其与已知的药物相互作用,可以长期安全用药。
具体实施方式
下面对本发明的具体实施例进行详细描述,以便于进一步理解本发明。以下实施例中所有使用的实验方法如无特殊说明,均为常规方法。以下实施例中所用的材料、试剂等,如无特殊说明,均可通过商业途径获得。
实施例1
一种海藻酸钠咀嚼片,包括以下重量份组份(mg):海藻酸钠200、碳酸氢钠300、碳酸钙150、氧化镁300、D-甘露糖醇50、聚乙二醇6000 200、羟丙基甲基纤维素E50 5、薄荷香精10、安赛蜜1、阿斯巴甜3、木糖醇DC级5、硬脂酸镁20。
一种海藻酸钠咀嚼片的制备方法,包括以下步骤:
(1)原料称取:按配方量称取各组份,备用;
(2)制粒:
(21)将聚乙二醇6000、羟丙基甲基纤维素加纯化水配制成20%和5%的浓度溶液,作粘合剂备用;
(22)再将配方量海藻酸钠、碳酸氢钠、碳酸钙、D-甘露糖醇、安赛蜜、阿斯巴甜混合均匀,加入粘合剂,30目制粒;
(3)干燥:将制好的湿颗粒在60℃下干燥30min,控制颗粒水分3%;
(4)整粒:将干燥好的颗粒过20目筛,整粒;
(5)总混:将干燥后的颗粒与氧化镁、薄荷香精、木糖醇混合25min;混合均匀后再加入硬脂酸镁混合5min,得总混物料;
(6)压片:用旋转式压片机进行压片,1.0g/片,定期检查片重差异。
实施例2
一种海藻酸钠咀嚼片,包括以下重量份组份(mg):海藻酸钠300、碳酸氢钠50、碳酸钙300、氧化镁30、D-甘露糖醇300、聚乙二醇6000 50、羟丙基甲基纤维素E50 20、薄荷香精1、安赛蜜3、阿斯巴甜1、木糖醇DC级100、硬脂酸镁5。
其制备方法同实施例1。
实施例3
一种海藻酸钠咀嚼片,包括以下重量份组份(mg):海藻酸钠225、碳酸氢钠120、碳酸钙250、氧化镁170、D-甘露糖醇220、聚乙二醇6000 100、羟丙基甲基纤维素E50 12、薄荷香精3、安赛蜜3、阿斯巴甜1、木糖醇DC级50、硬脂酸镁10。
其制备方法同实施例1。
实施例4
一种海藻酸钠咀嚼片,包括以下重量份组份(mg):海藻酸钠275、碳酸氢钠220、碳酸钙200、氧化镁40、D-甘露糖醇120、聚乙二醇6000 50、羟丙基甲基纤维素E50 18、薄荷香精8、安赛蜜1、阿斯巴甜3、木糖醇DC级5、硬脂酸镁15。
其制备方法同实施例1。
实施例5
一种海藻酸钠咀嚼片,包括以下重量份组份(mg):海藻酸钠275、碳酸氢钠133.5、碳酸钙212.5、氧化镁60、D-甘露糖醇200、聚乙二醇6000 60、羟丙基甲基纤维素E50 15、薄荷香精7.5、安赛蜜2、阿斯巴甜2.5、木糖醇DC级10、硬脂酸镁13.5。
其制备方法同实施例1。
实施例6
一种海藻酸钠咀嚼片,包括以下重量份组份(mg):海藻酸钠225、碳酸氢钠120、碳酸钙250、氧化镁170、D-甘露糖醇220、聚乙二醇6000 100、羟丙基甲基纤维素E50 12、薄荷香精3、安赛蜜3、阿斯巴甜1、木糖醇DC级50、硬脂酸镁10、葡萄糖酸锌5。
其制备方法同实施例1相似,不同之处在于步骤(22)中还包括葡萄糖酸锌。
实施例7
一种海藻酸钠咀嚼片,包括以下重量份组份(mg):海藻酸钠275、碳酸氢钠220、碳酸钙200、氧化镁40、D-甘露糖醇120、聚乙二醇6000 50、羟丙基甲基纤维素E50 18、薄荷香精8、安赛蜜1、阿斯巴甜3、木糖醇DC级5、硬脂酸镁15、葡萄糖酸锌20。
其制备方法同实施例1相似,不同之处在于步骤(22)中还包括葡萄糖酸锌。
实施例8
一种海藻酸钠咀嚼片,包括以下重量份组份(mg):海藻酸钠275、碳酸氢钠133.5、碳酸钙212.5、氧化镁60、D-甘露糖醇200、聚乙二醇6000 60、羟丙基甲基纤维素E50 15、薄荷香精7.5、安赛蜜2、阿斯巴甜2.5、木糖醇DC级10、硬脂酸镁13.5、葡萄糖酸锌8.5。
其制备方法与实施例1相似,不同之处在于步骤(22)中还包括葡萄糖酸锌。
对实施例1-8的产品的压片过程会否存在粘冲现象以及崩解时限进行考察,发现8款产品均未出现粘冲现象,同时对产品进行硬度测试,发现在口中咀嚼硬度适宜。也就是说,本申请生产的产品能够满足生产和使用的要求。
将实施例5和8制备得到的咀嚼片拿来进行以下人体实验(实施例5或实施例8的份数量即为1片咀嚼片的含量):
(1)选择符合慢性浅表性胃炎诊断标准且经胃镜筛选确诊为浅表性胃炎的自愿受试者400人(实施例5和实施例8各200人)进行受试实验。
慢性浅表性胃炎诊断标准:病程迁延,有不同程度的消化不良、上腹痛、烧心、嗳气、反酸、腹胀等临床症状,可有上腹部轻度压痛。符合慢性浅表性胃炎纤维胃镜诊断标准及活体组织检查诊断标准。排除胃溃疡患者、排除18岁以下65岁以上以及特殊群体。
(2)将受试者进行分组受试,试食组按推荐服用方法、服用量服用受试产品,在试验期间停用其它用于慢性胃病的物品,对照组不用药(空白对照)。按双盲法进行试食试验。观察时间30天。试验期间不改变原来的饮食习惯,正常饮食。
食用方法:每日3次,每次2片,饭后或睡前服用。
(3)观察受试者指标,主要包括安全指标和功效指标:
安全指标包括精神、睡眠、饮食、大小便以及血压等;检查血尿便等常规项目;检查肝肾功能;检查胸、心电图以及腹部B超等;
功效指标包括症状观察(胃痛、嗳气、反酸、食欲不振、少食等临床症状)。体征观察剑突下压痛程度。按症状轻重统计积分(重症3分,中度2分,轻度1分),见表1。
表1人体试食试验症状轻重分级表
胃镜检查与体征观察:剑突下压痛程度检查,根据疼痛程度分为轻(1分)、中(2分)、重(3分)。轻度:用力时才出现疼痛,压痛轻微1分;中度:用力即出现疼痛,但疼痛尚能忍受,压痛明显2分;重症:稍微用力即出现疼痛,疼痛不能忍受,压痛剧烈3分;随机选择试食组和对照组各50例受试者进行胃镜检查,比较试食试验前后的改变。
对400例受试者进行跟踪观察,对实施例5和实施例8的治疗效果进行对比发现,实施例8增加了葡糖糖酸锌,虽然整体治疗周期没有较大改变,但是由于在治疗初期增加了锌元素,胃部受损的溃疡面恢复的更快,可以缩短患者被病痛折磨的时间。总体上来说,用药20天后,50%以上的患者症状得到明显改善,用药25天后,78%的患者症状得到缓解或减轻(胃溃疡患者伴有仪器检测溃疡面减小),用药30天后,90%以上的患者症状得到缓解或减轻(胃溃疡患者伴有仪器检测溃疡面减小)。
一种海藻酸钠咀嚼片在制备具有治疗胃食管反流和补充矿物元素钙、镁的药品或食品中的应用。
一种海藻酸钠咀嚼片在制备具有治疗胃食管反流和补充矿物元素钙、镁、锌的药品或食品中的应用。
本发明的海藻酸钠咀嚼片可以应用于所有治疗胃食管反流的药物中,可以作为主要或辅药与其他要去一起使用,也可以单独使用,药效明显,且可以长期使用,用药安全。
虽然本发明已以实施例公开如上,然其并非用于限定本发明,任何本领域技术人员,在不脱离本发明的精神和范围内,均可作各种不同的选择和修改,因此本发明的保护范围由权利要求书及其等同形式所限定。
Claims (10)
1.一种海藻酸钠咀嚼片,其特征在于,包括以下重量份组份:海藻酸钠200-300、碳酸氢钠50-300、碳酸钙150-300、氧化镁30-300、D-甘露糖醇50-300、聚乙二醇6000 50-200、羟丙基甲基纤维素E50 5-20、薄荷香精1-10、安赛蜜1-3、阿斯巴甜1-3、木糖醇DC级5-100、硬脂酸镁5-20。
2.根据权利要求1所述的海藻酸钠咀嚼片,其特征在于,包括以下重量份组份:海藻酸钠225-275、碳酸氢钠120-220、碳酸钙200-250、氧化镁40-170、D-甘露糖醇120-220、聚乙二醇6000 50-100、羟丙基甲基纤维素E5012-18、薄荷香精3-8、安赛蜜1-3、阿斯巴甜1-3、木糖醇DC级5-50、硬脂酸镁10-15。
3.根据权利要求2所述的海藻酸钠咀嚼片,其特征在于,包括以下重量份组份:海藻酸钠275、碳酸氢钠133.5、碳酸钙212.5、氧化镁60、D-甘露糖醇200、聚乙二醇6000 60、羟丙基甲基纤维素E50 15、薄荷香精7.5、安赛蜜2、阿斯巴甜2.5、木糖醇DC级10、硬脂酸镁13.5。
4.根据权利要求1、2或3所述的海藻酸钠咀嚼片,其特征在于,所述海藻酸钠咀嚼片还包括以下重量份组份:葡萄糖酸锌5-20。
5.根据权利要求4所述的海藻酸钠咀嚼片,其特征在于,所述海藻酸钠咀嚼片还包括以下重量份组份:葡萄糖酸锌优选为8.5。
6.根据权利要求1-5任一所述的海藻酸钠咀嚼片的制备方法,其特征在于,包括以下步骤:
(1)原料称取:按配方量称取各组份,备用;
(2)制粒:
(21)将聚乙二醇6000、羟丙基甲基纤维素加纯化水配制成20%和5%的浓度溶液,作粘合剂备用;
(22)再将配方量海藻酸钠、碳酸氢钠、碳酸钙、D-甘露糖醇、安赛蜜、阿斯巴甜混合均匀,加入粘合剂,30目制粒;
(3)干燥:将制好的湿颗粒在40-80℃下干燥20-60min,控制颗粒水分3%;
(4)整粒:将干燥好的颗粒过20目筛,整粒;
(5)总混:将干燥后的颗粒与氧化镁、薄荷香精、木糖醇混合25min;混合均匀后再加入硬脂酸镁混合5min,得总混物料;
(6)压片:用旋转式压片机进行压片,1.0g/片,定期检查片重差异。
7.根据权利要求6所述的海藻酸钠咀嚼片的制备方法,其特征在于,所述步骤(22)的混合物中还包括葡萄糖酸锌。
8.根据权利要求6所述的海藻酸钠咀嚼片的制备方法,其特征在于,所述步骤(3)干燥的温度为60℃,干燥时间为30min。
9.根据权利要求6-8任一所述制备方法制备的海藻酸钠咀嚼片在制备具有治疗胃食管反流和补充矿物元素钙、镁的药品或食品中的应用。
10.根据权利要求6-8任一所述制备方法制备的海藻酸钠咀嚼片在制备具有治疗胃食管反流和补充矿物元素钙、镁、锌的药品或食品中的应用。
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