CN101797235B - Carbazochrome sodium sulfonate orally disintegrating tablet and preparation method thereof - Google Patents
Carbazochrome sodium sulfonate orally disintegrating tablet and preparation method thereof Download PDFInfo
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- CN101797235B CN101797235B CN2010101290751A CN201010129075A CN101797235B CN 101797235 B CN101797235 B CN 101797235B CN 2010101290751 A CN2010101290751 A CN 2010101290751A CN 201010129075 A CN201010129075 A CN 201010129075A CN 101797235 B CN101797235 B CN 101797235B
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- sodium sulfonate
- carbazochrome sodium
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- 229960004353 carbazochrome sodium sulfonate Drugs 0.000 title claims abstract description 67
- HLFCZZKCHVSOAP-WXIWBVQFSA-M sodium;(5e)-5-(carbamoylhydrazinylidene)-1-methyl-6-oxo-2,3-dihydroindole-2-sulfonate Chemical compound [Na+].NC(=O)N\N=C/1C(=O)C=C2N(C)C(S([O-])(=O)=O)CC2=C\1 HLFCZZKCHVSOAP-WXIWBVQFSA-M 0.000 title claims abstract description 67
- 238000002360 preparation method Methods 0.000 title abstract description 9
- 239000006191 orally-disintegrating tablet Substances 0.000 title abstract 4
- 238000000034 method Methods 0.000 claims abstract description 21
- 239000000945 filler Substances 0.000 claims abstract description 19
- 239000000314 lubricant Substances 0.000 claims abstract description 16
- 239000007884 disintegrant Substances 0.000 claims abstract description 14
- 239000008187 granular material Substances 0.000 claims description 51
- 239000003795 chemical substances by application Substances 0.000 claims description 30
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims description 27
- 229920002472 Starch Polymers 0.000 claims description 25
- 239000008107 starch Substances 0.000 claims description 25
- 235000019698 starch Nutrition 0.000 claims description 25
- 239000001253 polyvinylpolypyrrolidone Substances 0.000 claims description 24
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 claims description 24
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 claims description 24
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical group [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 22
- 238000002156 mixing Methods 0.000 claims description 22
- NOOLISFMXDJSKH-UHFFFAOYSA-N p-menthan-3-ol Chemical compound CC(C)C1CCC(C)CC1O NOOLISFMXDJSKH-UHFFFAOYSA-N 0.000 claims description 17
- 206010013786 Dry skin Diseases 0.000 claims description 15
- 239000011230 binding agent Substances 0.000 claims description 15
- 238000001035 drying Methods 0.000 claims description 15
- 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 14
- 229930195725 Mannitol Natural products 0.000 claims description 14
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- 239000000594 mannitol Substances 0.000 claims description 14
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- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 14
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 14
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 claims description 12
- 108010011485 Aspartame Proteins 0.000 claims description 11
- 239000000605 aspartame Substances 0.000 claims description 11
- 235000010357 aspartame Nutrition 0.000 claims description 11
- 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 description 11
- 229960003438 aspartame Drugs 0.000 claims description 11
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims description 11
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 11
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 11
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical group 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 description 11
- 235000019359 magnesium stearate Nutrition 0.000 claims description 11
- 239000000843 powder Substances 0.000 claims description 11
- 238000010298 pulverizing process Methods 0.000 claims description 9
- 239000007779 soft material Substances 0.000 claims description 9
- IDGUHHHQCWSQLU-UHFFFAOYSA-N ethanol;hydrate Chemical compound O.CCO IDGUHHHQCWSQLU-UHFFFAOYSA-N 0.000 claims description 8
- 235000017557 sodium bicarbonate Nutrition 0.000 claims description 6
- 229910000030 sodium bicarbonate Inorganic materials 0.000 claims description 6
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- 239000007789 gas Substances 0.000 claims description 3
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- 238000010579 first pass effect Methods 0.000 abstract description 3
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- 238000005550 wet granulation Methods 0.000 abstract description 2
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- 238000011031 large-scale manufacturing process Methods 0.000 abstract 1
- 239000007788 liquid Substances 0.000 abstract 1
- 238000001356 surgical procedure Methods 0.000 abstract 1
- 239000003826 tablet Substances 0.000 description 56
- 229960001855 mannitol Drugs 0.000 description 13
- 239000000203 mixture Substances 0.000 description 11
- 235000015165 citric acid Nutrition 0.000 description 6
- CDBYLPFSWZWCQE-UHFFFAOYSA-L sodium carbonate Substances [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 description 6
- VZCYOOQTPOCHFL-OWOJBTEDSA-N Fumaric acid Chemical compound OC(=O)\C=C\C(O)=O VZCYOOQTPOCHFL-OWOJBTEDSA-N 0.000 description 4
- 229960004106 citric acid Drugs 0.000 description 4
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- 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 3
- UIIMBOGNXHQVGW-DEQYMQKBSA-M Sodium bicarbonate-14C Chemical compound [Na+].O[14C]([O-])=O UIIMBOGNXHQVGW-DEQYMQKBSA-M 0.000 description 3
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 description 3
- 239000001768 carboxy methyl cellulose Substances 0.000 description 3
- 125000002057 carboxymethyl group Chemical group [H]OC(=O)C([H])([H])[*] 0.000 description 3
- 238000004132 cross linking Methods 0.000 description 3
- 229940031703 low substituted hydroxypropyl cellulose Drugs 0.000 description 3
- 239000011734 sodium Substances 0.000 description 3
- 229910052708 sodium Inorganic materials 0.000 description 3
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 description 3
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 description 3
- 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 description 2
- RZVAJINKPMORJF-UHFFFAOYSA-N Acetaminophen Chemical compound CC(=O)NC1=CC=C(O)C=C1 RZVAJINKPMORJF-UHFFFAOYSA-N 0.000 description 2
- 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 description 2
- CURLTUGMZLYLDI-UHFFFAOYSA-N Carbon dioxide Chemical compound O=C=O CURLTUGMZLYLDI-UHFFFAOYSA-N 0.000 description 2
- 208000019505 Deglutition disease Diseases 0.000 description 2
- 229920001353 Dextrin Polymers 0.000 description 2
- 239000004375 Dextrin Substances 0.000 description 2
- FEWJPZIEWOKRBE-JCYAYHJZSA-N Dextrotartaric acid Chemical compound OC(=O)[C@H](O)[C@@H](O)C(O)=O FEWJPZIEWOKRBE-JCYAYHJZSA-N 0.000 description 2
- 239000004386 Erythritol Substances 0.000 description 2
- UNXHWFMMPAWVPI-UHFFFAOYSA-N Erythritol Natural products OCC(O)C(O)CO UNXHWFMMPAWVPI-UHFFFAOYSA-N 0.000 description 2
- 239000001856 Ethyl cellulose Substances 0.000 description 2
- ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical compound CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 description 2
- 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 description 2
- 229920000881 Modified starch Polymers 0.000 description 2
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 2
- UEDUENGHJMELGK-HYDKPPNVSA-N Stevioside Chemical compound O([C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@H]1O[C@]12C(=C)C[C@@]3(C1)CC[C@@H]1[C@@](C)(CCC[C@]1([C@@H]3CC2)C)C(=O)O[C@H]1[C@@H]([C@@H](O)[C@H](O)[C@@H](CO)O1)O)[C@@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O UEDUENGHJMELGK-HYDKPPNVSA-N 0.000 description 2
- FEWJPZIEWOKRBE-UHFFFAOYSA-N Tartaric acid Natural products [H+].[H+].[O-]C(=O)C(O)C(O)C([O-])=O FEWJPZIEWOKRBE-UHFFFAOYSA-N 0.000 description 2
- TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 description 2
- 239000002253 acid Substances 0.000 description 2
- 238000006243 chemical reaction Methods 0.000 description 2
- 235000009508 confectionery Nutrition 0.000 description 2
- 235000019425 dextrin Nutrition 0.000 description 2
- FPAFDBFIGPHWGO-UHFFFAOYSA-N dioxosilane;oxomagnesium;hydrate Chemical compound O.[Mg]=O.[Mg]=O.[Mg]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O FPAFDBFIGPHWGO-UHFFFAOYSA-N 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 235000019414 erythritol Nutrition 0.000 description 2
- UNXHWFMMPAWVPI-ZXZARUISSA-N erythritol Chemical compound OC[C@H](O)[C@H](O)CO UNXHWFMMPAWVPI-ZXZARUISSA-N 0.000 description 2
- 229940009714 erythritol Drugs 0.000 description 2
- 235000019325 ethyl cellulose Nutrition 0.000 description 2
- 229920001249 ethyl cellulose Polymers 0.000 description 2
- 239000001530 fumaric acid Substances 0.000 description 2
- 235000011087 fumaric acid Nutrition 0.000 description 2
- 230000002496 gastric effect Effects 0.000 description 2
- 239000007924 injection Substances 0.000 description 2
- 238000002347 injection Methods 0.000 description 2
- 239000008101 lactose Substances 0.000 description 2
- 229960001375 lactose Drugs 0.000 description 2
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 description 2
- 229920000609 methyl cellulose Polymers 0.000 description 2
- 239000001923 methylcellulose Substances 0.000 description 2
- 235000010981 methylcellulose Nutrition 0.000 description 2
- 239000000825 pharmaceutical preparation Substances 0.000 description 2
- 239000003507 refrigerant Substances 0.000 description 2
- 238000011160 research Methods 0.000 description 2
- 229940085605 saccharin sodium Drugs 0.000 description 2
- 238000007873 sieving Methods 0.000 description 2
- 239000000741 silica gel Substances 0.000 description 2
- 229910002027 silica gel Inorganic materials 0.000 description 2
- 229910000029 sodium carbonate Inorganic materials 0.000 description 2
- 235000017550 sodium carbonate Nutrition 0.000 description 2
- 239000000243 solution Substances 0.000 description 2
- 229940032147 starch Drugs 0.000 description 2
- 230000008961 swelling Effects 0.000 description 2
- 239000011975 tartaric acid Substances 0.000 description 2
- 235000002906 tartaric acid Nutrition 0.000 description 2
- VZCYOOQTPOCHFL-UHFFFAOYSA-N trans-butenedioic acid Natural products OC(=O)C=CC(O)=O VZCYOOQTPOCHFL-UHFFFAOYSA-N 0.000 description 2
- 230000002485 urinary effect Effects 0.000 description 2
- 239000000811 xylitol Substances 0.000 description 2
- 235000010447 xylitol Nutrition 0.000 description 2
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 description 2
- 229960002675 xylitol Drugs 0.000 description 2
- 206010070840 Gastrointestinal tract irritation Diseases 0.000 description 1
- 241000167880 Hirundinidae Species 0.000 description 1
- 206010051077 Post procedural haemorrhage Diseases 0.000 description 1
- 208000037486 Postoperative Hemorrhage Diseases 0.000 description 1
- 206010071229 Procedural haemorrhage Diseases 0.000 description 1
- 229930006000 Sucrose Natural products 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
- 239000002671 adjuvant Substances 0.000 description 1
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- 150000007516 brønsted-lowry acids Chemical class 0.000 description 1
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- 230000005284 excitation Effects 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 239000000706 filtrate Substances 0.000 description 1
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- 230000000025 haemostatic effect Effects 0.000 description 1
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- 150000007524 organic acids Chemical class 0.000 description 1
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- 210000002345 respiratory system Anatomy 0.000 description 1
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- PAYGMRRPBHYIMA-UHFFFAOYSA-N sodium;trihydrate Chemical compound O.O.O.[Na] PAYGMRRPBHYIMA-UHFFFAOYSA-N 0.000 description 1
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- 239000005720 sucrose Substances 0.000 description 1
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- 230000002588 toxic effect Effects 0.000 description 1
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- Medicinal Preparation (AREA)
Abstract
The invention discloses a carbazochrome sodium sulfonate orally disintegrating tablet and a preparation method thereof, wherein the orally disintegrating tablet comprises the following components in percentage by mass: 1 to 15 percent of carbazochrome sodium sulfonate, 50 to 90 percent of filler, 5 to 40 percent of disintegrant, 1 to 8 percent of adhesive, 0.1 to 5 percent of lubricant and 0.1 to 5 percent of flavoring agent; the oral liquid has the advantages of smooth and attractive surface, proper hardness, rapid disintegration without water in the oral cavity, rapid absorption, quick effect, small first pass effect of the liver, high bioavailability, small irritation to the gastrointestinal tract, good taste and convenient taking, and is particularly suitable for the old, children, patients lying in bed or having difficulty in swallowing, especially patients who have inconvenience in drinking water due to hemorrhage in or after surgery; the orally disintegrating tablet is prepared by a wet granulation tabletting method, has simple production process, stable and easily controlled preparation quality and low cost, and is suitable for industrial large-scale production.
Description
Technical field
The present invention relates to a kind of pharmaceutical preparation, particularly a kind of carbazochrome sodium sulfonate oral disintegrating tablets also relates to the method for preparing of this oral cavity disintegration tablet.
Background technology
Tablet have steady quality, dosage accurately, take and advantage such as easy to carry, that the production mechanization degree high, production cost is low, be one of at present the most frequently used pharmaceutical dosage form.But disintegrate is slow, bioavailability is lower, part patient swallows than deficiencies such as difficulties because of it exists simultaneously, on using, receives restriction to a certain degree.In recent years, novel troches such as oral cavity disintegration tablet, dispersible tablet and Sublingual tablet continue to bring out.Oral cavity disintegration tablet is a kind of water disintegrate or dissolved tablet fast of in the oral cavity, not needing; Have fast, rapid-action, the advantages such as liver first-pass effect is little, bioavailability is high, GI irritation is little, taking convenience of absorption, be particularly suitable for the patient of old man, child, bed, dysphagia or drinking-water inconvenience.
Carbazochrome sodium sulfonate (Carbazochrome Sodium Sulfonate); Chemical name is 1-methyl-6-oxo-2,3,5; 6-tetrahydro indole-5-semicarbazone-2-sulfonate sodium trihydrate; Be the take the lead in hemorrhage of new generation of successful development of Japanese Tanabe Mitsubishi Pharmaceutical Co, have that haemostatic effect is good, onset rapidly, advantage such as persistent, toxic and side effects be little, be mainly used in urinary system, upper digestive tract, respiratory tract and department of obstetrics and gynecology hemorrhagic disease; Comparatively remarkable to the urinary system curative effect, also can be used for prevention and treatment of operative hemorrhage etc.
Carbazochrome sodium sulfonate
The preparation type that carbazochrome sodium sulfonate has gone on the market mainly contains conventional tablet, capsule, powder, granule, injection and injection powder pin etc., does not see the oral cavity disintegration tablet listing at present as yet, does not also see the correlational study report.
Summary of the invention
In view of this, one of the object of the invention is to provide a kind of carbazochrome sodium sulfonate oral disintegrating tablets, and two of purpose is to provide a kind of method for preparing of said carbazochrome sodium sulfonate oral disintegrating tablets.
For achieving the above object, the present invention adopts following technical scheme:
1, carbazochrome sodium sulfonate oral disintegrating tablets, composed of the following components by mass percentage: carbazochrome sodium sulfonate 1%～15%, filler 50%～90%, disintegrating agent 5%～40%, binding agent 1%～8%, lubricant 0.1%～5% and correctives 0.1%～5%.
Further, composed of the following components by mass percentage: carbazochrome sodium sulfonate 1%～10%, filler 65%～85%, disintegrating agent 5%～20%, binding agent 2%～6%, lubricant 0.1%～1% and correctives 0.4%～1.5%;
Further, composed of the following components by mass percentage: carbazochrome sodium sulfonate 8%～9%, filler 74%～80%, disintegrating agent 6%～12%, binding agent 3%～5%, lubricant 0.4%～0.5% and correctives 0.4%～1.0%;
Further, said filler is one or more in starch, pregelatinized Starch, dextrin, Icing Sugar, lactose, mannitol, xylitol, erythritol and the microcrystalline Cellulose; Said disintegrating agent is one or more in low-substituted hydroxypropyl cellulose, cross-linking sodium carboxymethyl cellulose, crosslinked carboxymethyl fecula sodium, polyvinylpolypyrrolidone and the gas-producing disintegrant, and gas-producing disintegrant is made up of tartaric acid, citric acid or fumaric acid and sodium bicarbonate or sodium carbonate; Said binding agent is one or more in starch, methylcellulose, ethyl cellulose and the hydroxypropyl methylcellulose; Said lubricant is one or more in magnesium stearate, Pulvis Talci and the micropowder silica gel; Said correctives is one or more in saccharin sodium, aspartame, steviosin and the Mentholum;
Further, said filler is one or more in starch, mannitol and the microcrystalline Cellulose; Said disintegrating agent is polyvinylpolypyrrolidone and/or gas-producing disintegrant; Said binding agent is a hydroxypropyl methylcellulose; Said lubricant is a magnesium stearate; Said correctives is Mentholum and/or aspartame;
Further, said filler is starch, mannitol and microcrystalline Cellulose; Said disintegrating agent is polyvinylpolypyrrolidone or polyvinylpolypyrrolidone and gas-producing disintegrant, and gas-producing disintegrant is made up of citric acid and sodium bicarbonate; Said correctives is Mentholum or Mentholum and aspartame.
2, the method for preparing of said carbazochrome sodium sulfonate oral disintegrating tablets adopts the wet granule compression tablet method, may further comprise the steps:
A, pulverizing: filler, disintegrating agent, binding agent, lubricant and correctives pulverize separately are become the fine powder of fineness more than 100 orders;
B, granulation: with carbazochrome sodium sulfonate and partially filled dose of mixing, pulverize, cross 80 mesh sieves; Again with the residue filler, in disintegrating agent, binding agent, in add the correctives mixing, cross 80 mesh sieves; Add wetting agent system soft material again, 20～40 mesh sieves are granulated, 60 ± 5 ℃ of dryings, and dried granule is crossed 20～60 mesh sieve granulate;
C, tabletting: with the dried granule behind the step b granulate with add disintegrating agent, lubricant, add the correctives mixing, tabletting promptly gets carbazochrome sodium sulfonate oral disintegrating tablets.
Further, the wetting agent among the said step b is that volume fraction is 60% ethanol water;
Further, adopt 24 mesh sieves to granulate among the said step b, dried granule is crossed 24 mesh sieve granulate.
Beneficial effect of the present invention is: carbazochrome sodium sulfonate oral disintegrating tablets any surface finish of the present invention, attractive in appearance, and hardness is suitable; Needn't use water delivery service, saliva can make its rapidly disintegrate in the oral cavity, and taking convenience is particularly suitable for the patient of old man, child, bed or dysphagia, especially in the operation or postoperative hemorrhage and the patient of the inconvenience of drinking water; Cool taste, sweetness, exquisiteness, the patient is easy to accept, and drug compliance is good; Medicine after the disintegrate has the direct trans-oral of considerable part to absorb except that part gets into the gastrointestinal tract with swallowing act, and rapid-action, liver first-pass effect is little, and bioavailability is high; Getting into the gastrointestinal medicine is homodisperse fine particle, in gastrointestinal tract, is large tracts of land and distributes, and absorption point increases, and local excitation reduces to gastrointestinal; The present invention adopts the wet granule compression tablet legal system to be equipped with carbazochrome sodium sulfonate oral disintegrating tablets, and production technology is simple, and stable being prone to of the quality of the pharmaceutical preparations controlled, and be with low cost, is fit to large-scale industrialization production.
The present invention is " Chongqing City's veterinary drug Engineering Technical Research Centre " research project.
The specific embodiment
In order to make the object of the invention, technical scheme and advantage clearer, will carry out detailed description to the preferred embodiments of the present invention below.
Carbazochrome sodium sulfonate oral disintegrating tablets of the present invention, composed of the following components by mass percentage:
Carbazochrome sodium sulfonate: 1%～15%, preferred 1%～10%, more preferably 8%～9%;
Filler: 50%～90%, preferred 65%～85%, more preferably 74%～80%;
Disintegrating agent: 5%～40%, preferred 5%～20%, more preferably 6%～12%;
Binding agent: 1%～8%, preferred 2%～6%, more preferably 3%～5%;
Lubricant: 0.1%～5%, preferred 0.1%～1%, more preferably 0.4%～0.5%;
Correctives: 0.1%～5%, preferred 0.4%～1.5%, more preferably 0.4%～1.0%.
Said filler is selected from one or more in starch, pregelatinized Starch, dextrin, Icing Sugar, lactose, mannitol, xylitol, erythritol and the microcrystalline Cellulose; In preferred starch, mannitol and the microcrystalline Cellulose one or more, more preferably mannitol, starch and microcrystalline Cellulose.Starch property is highly stable, low price, and hygroscopicity is little, and water absorption is strong and certain dilatancy is arranged, and is applicable to water-insoluble or microsolubility medicine.Mannitol is soluble in water, stable in properties, and no hygroscopicity, sugariness is equivalent to 70% of sucrose approximately, and heat absorption during because of dissolving has refrigerant sense when dissolving in the oral cavity.Microcrystalline Cellulose is water insoluble; Have good flowability and compressibility; Except that as also having concurrently lubricated the filler and disintegration, during with the strong low-substituted hydroxypropyl cellulose of swelling behavior, cross-linking sodium carboxymethyl cellulose, crosslinked carboxymethyl fecula sodium, polyvinylpolypyrrolidone Combined application, can improve the porosity of tablet; Strengthen capillarity, make tablet disintegrate fast in low amounts of water.
Said disintegrating agent is selected from one or more in low-substituted hydroxypropyl cellulose, cross-linking sodium carboxymethyl cellulose, crosslinked carboxymethyl fecula sodium, polyvinylpolypyrrolidone and the gas-producing disintegrant; Preferred polyvinylpolypyrrolidone and/or gas-producing disintegrant, more preferably polyvinylpolypyrrolidone or polyvinylpolypyrrolidone and gas-producing disintegrant.Polyvinylpolypyrrolidone has very high capillary activity and hydratability, can rapidly water be absorbed in the tablet, and when internal pressure is the intensity that swelling power surpasses tablet, disintegrate promptly takes place tablet, is efficient tablet disintegrant.Gas-producing disintegrant is made up of organic acid and weak base, and carbon dioxide makes the quick disintegrate of tablet thereby soda acid is met water reaction generation.In the present invention, said gas-producing disintegrant preferably is made up of tartaric acid, citric acid or fumaric acid and sodium bicarbonate or sodium carbonate, more preferably is made up of citric acid and sodium bicarbonate.
Said binding agent is selected from one or more in starch, methylcellulose, ethyl cellulose and the hydroxypropyl methylcellulose, preferred hydroxypropyl methylcellulose.
Said lubricant is selected from one or more in magnesium stearate, Pulvis Talci and the micropowder silica gel, preferred magnesium stearate.
Because oral cavity disintegration tablet is disintegrate or dissolving in the oral cavity, so when the preparation oral cavity disintegration tablet, should be specifically noted that sensory issues.Added correctives in the oral cavity disintegration tablet of the present invention, said correctives is selected from one or more in saccharin sodium, aspartame, steviosin and the Mentholum, preferred aspartame and/or Mentholum, more preferably Mentholum or aspartame and Mentholum.
Carbazochrome sodium sulfonate oral disintegrating tablets of the present invention adopts the preparation of wet granule compression tablet method, may further comprise the steps:
A, pulverizing: filler, disintegrating agent, binding agent, lubricant and correctives pulverize separately are become the fine powder of fineness more than 100 orders;
B, granulation: with carbazochrome sodium sulfonate and partially filled dose of mixing, pulverize, cross 80 mesh sieves; Again with the residue filler, in disintegrating agent, binding agent, in add the correctives mixing, cross 80 mesh sieves; Add wetting agent system soft material again, 20～40 mesh sieves are granulated, 60 ± 5 ℃ of dryings, and dried granule is crossed 20～60 mesh sieve granulate;
C, tabletting: with the dried granule behind the step b granulate with add disintegrating agent, lubricant, add the correctives mixing, tabletting promptly gets carbazochrome sodium sulfonate oral disintegrating tablets.
When wet granule compression tablet, should note following some: (1) is prone to when pulverizing separately stick on the machine because the water content of principal agent carbazochrome sodium sulfonate is about 15%, and a small amount of adhesion becomes strip and block, is difficult for sieving; Simultaneously, the water content of filler starch also higher (being generally 10%～15%) is mixed difficulty of pulverizing with principal agent, be difficult for sieving; Therefore, among the present invention starch with before should 100～105 ℃ in advance dry, make water content below 8%; Simultaneously,, pulverize, sieve, mix with other adjuvant again carbazochrome sodium sulfonate elder generation and dry starch mixing.(2) method that is routinely added to of disintegrating agent has three kinds: addition 1.: granulate behind disintegrating agent and other composition mix homogeneously, thereby make disintegrating agent be present in granule interior, though disintegrate is slower, once just beading of disintegrate, help stripping; 2. outer addition: disintegrating agent is added in the dried granule behind the granulate, thereby makes disintegrating agent be present in outside the granule and between each granule, after moisture content penetrated, disintegrate was rapid, but because of there not being disintegrating agent in the granule, easy disintegrating beading not, and stripping is poor slightly; 3. inside and outside addition: disintegrating agent is divided into two parts, and a by interior addition adding, another part adds by outer addition.Discover through single factor experiment,, more help the quick disintegrate of oral cavity disintegration tablet when disintegrating agent adds fashionablely by inside and outside addition.Therefore, the present invention adopts inside and outside addition to add disintegrating agent.Wherein, the adding method of gas-producing disintegrant is: with granulating behind the wherein a kind of of bronsted lowry acids and bases bronsted lowry and other composition mix homogeneously, another kind is added in the dried granule behind the granulate, thereby avoids the living reaction of soda acid chance waterishlogging when wet granulation.(3) because correctives such as Mentholum etc. have effumability; The present invention adds volatile correctives before being chosen in and granulating, and reduces its volatilization loss as far as possible, remains not volatile correctives and then after granulation, adds; Make made tablet outer sweet, on mouthfeel, more be prone to accepted by the patient.
Discover, adopt the carbazochrome sodium sulfonate oral disintegrating tablets of above-mentioned supplementary material and method preparation, any surface finish, attractive in appearance, hardness is suitable, and disintegrate and pass through 30 mesh sieves fully in 30 seconds meets the requirement of oral cavity disintegration tablet in 37 ± 1 ℃ of water.
Embodiment 1
Prescription
All components pulverize separately during method for making will be write out a prescription except that carbazochrome sodium sulfonate becomes the fine powder of fineness more than 100 orders; 100～105 ℃ of dryings, make water content starch below 8%; With the carbazochrome sodium sulfonate and the dry starch mixing of recipe quantity, pulverize, cross 80 mesh sieves; Mix with mannitol, microcrystalline Cellulose, hydroxypropyl methylcellulose and the Mentholum of recipe quantity and the polyvinylpolypyrrolidone of 1/2 recipe quantity again, cross 80 mesh sieves; Add volume fraction again and be 60% ethanol water and make soft material in right amount, 24 mesh sieves are granulated, 60 ± 5 ℃ of dryings, and dried granule is crossed 24 mesh sieve granulate; The magnesium stearate that in dried granule, adds residue polyvinylpolypyrrolidone and recipe quantity again, mixing, tabletting is processed 1000 of carbazochrome sodium sulfonate oral disintegrating tablets altogether, and every contains carbazochrome sodium sulfonate 10mg.
Quality gained oral cavity disintegration tablet any surface finish, attractive in appearance; Hardness is 22～27 Ns and pauses; 30 mesh sieves are also passed through in complete disintegrate in 24 seconds in 37 ± 1 ℃ of water; Taste and sweet mouthfeel, refrigerant, fine and smooth, no grittiness.
Embodiment 2
Prescription
All components pulverize separately during method for making will be write out a prescription except that carbazochrome sodium sulfonate becomes the fine powder of fineness more than 100 orders; 100～105 ℃ of dryings, make water content starch below 8%; With the carbazochrome sodium sulfonate and the dry starch mixing of recipe quantity, pulverize, cross 80 mesh sieves; Mix with mannitol, microcrystalline Cellulose, citric acid, hydroxypropyl methylcellulose and the Mentholum of recipe quantity and the polyvinylpolypyrrolidone of 1/2 recipe quantity again, cross 80 mesh sieves; Add volume fraction again and be 60% ethanol water and make soft material in right amount, 24 mesh sieves are granulated, 60 ± 5 ℃ of dryings, and dried granule is crossed 24 mesh sieve granulate; The sodium bicarbonate and the magnesium stearate that in dried granule, add residue polyvinylpolypyrrolidone and recipe quantity again, mixing, tabletting is processed 1000 of carbazochrome sodium sulfonate oral disintegrating tablets altogether, and every contains carbazochrome sodium sulfonate 10mg.
Quality gained oral cavity disintegration tablet any surface finish, attractive in appearance; Hardness is 21～28 Ns and pauses; 30 mesh sieves are also passed through in complete disintegrate in 23 seconds in 37 ± 1 ℃ of water; Cool taste, sweetness, exquisiteness, no grittiness.
Embodiment 3
Prescription
All components pulverize separately during method for making will be write out a prescription except that carbazochrome sodium sulfonate becomes the fine powder of fineness more than 100 orders; 100～105 ℃ of dryings, make water content starch below 8%; With the carbazochrome sodium sulfonate of recipe quantity and dry starch mixing, pulverizing, cross 80 mesh sieves; Mix with mannitol, microcrystalline Cellulose, hydroxypropyl methylcellulose and the Mentholum of recipe quantity and the polyvinylpolypyrrolidone of 1/2 recipe quantity again, cross 80 mesh sieves; Add volume fraction again and be 60% ethanol water and make soft material in right amount, 24 mesh sieves are granulated, 60 ± 5 ℃ of dryings, and dried granule is crossed 24 mesh sieve granulate; The magnesium stearate and the aspartame that in dried granule, add residue polyvinylpolypyrrolidone and recipe quantity again, mixing, tabletting is processed 1000 of carbazochrome sodium sulfonate oral disintegrating tablets altogether, and every contains carbazochrome sodium sulfonate 10mg.
Quality gained oral cavity disintegration tablet any surface finish, attractive in appearance; Hardness is 22～27 Ns and pauses; 30 mesh sieves are also passed through in complete disintegrate in 25 seconds in 37 ± 1 ℃ of water; Cool taste, sweetness, exquisiteness, no grittiness.
Embodiment 4
Prescription
All components pulverize separately during method for making will be write out a prescription except that carbazochrome sodium sulfonate becomes the fine powder of fineness more than 100 orders; 100～105 ℃ of dryings, make water content starch below 8%; With the carbazochrome sodium sulfonate of recipe quantity and dry starch mixing, pulverizing, cross 80 mesh sieves; Mix with mannitol, microcrystalline Cellulose, citric acid, hydroxypropyl methylcellulose and the Mentholum of recipe quantity and the polyvinylpolypyrrolidone of 1/2 recipe quantity again, cross 80 mesh sieves; Add volume fraction again and be 60% ethanol water and make soft material in right amount, 24 mesh sieves are granulated, 60 ± 5 ℃ of dryings, and dried granule is crossed 24 mesh sieve granulate; The sodium bicarbonate, magnesium stearate and the aspartame that in dried granule, add residue polyvinylpolypyrrolidone and recipe quantity again, mixing, tabletting is processed 1000 of carbazochrome sodium sulfonate oral disintegrating tablets altogether, and every contains carbazochrome sodium sulfonate 10mg.
Quality gained oral cavity disintegration tablet any surface finish, attractive in appearance; Hardness is 17～27 Ns and pauses; 30 mesh sieves are also passed through in complete disintegrate in 28 seconds in 37 ± 1 ℃ of water; Cool taste, sweetness, exquisiteness, no grittiness.
Embodiment 5
Prescription
All components pulverize separately during method for making will be write out a prescription except that carbazochrome sodium sulfonate becomes the fine powder of fineness more than 100 orders; 100～105 ℃ of dryings, make water content starch below 8%; With the carbazochrome sodium sulfonate of recipe quantity and dry starch mixing, pulverizing, cross 80 mesh sieves; Mix with mannitol, microcrystalline Cellulose, citric acid, hydroxypropyl methylcellulose and the Mentholum of recipe quantity and the polyvinylpolypyrrolidone of 1/2 recipe quantity again, cross 80 mesh sieves; Add volume fraction again and be 60% ethanol water and make soft material in right amount, 24 mesh sieves are granulated, 60 ± 5 ℃ of dryings, and dried granule is crossed 24 mesh sieve granulate; The sodium bicarbonate, magnesium stearate and the aspartame that in dried granule, add residue polyvinylpolypyrrolidone and recipe quantity again, mixing, tabletting is processed 1000 of carbazochrome sodium sulfonate oral disintegrating tablets altogether, and every contains carbazochrome sodium sulfonate 10mg.
Quality gained oral cavity disintegration tablet any surface finish, attractive in appearance; Hardness is 23～28 Ns and pauses; 30 mesh sieves are also passed through in complete disintegrate in 30 seconds in 37 ± 1 ℃ of water; Cool taste, sweetness, exquisiteness, no grittiness.
Embodiment 6
Prescription
All components pulverize separately during method for making will be write out a prescription except that carbazochrome sodium sulfonate becomes the fine powder of fineness more than 100 orders; 100～105 ℃ of dryings, make water content starch below 8%; With the carbazochrome sodium sulfonate of recipe quantity and dry starch mixing, pulverizing, cross 80 mesh sieves; Mix with mannitol, microcrystalline Cellulose, citric acid, hydroxypropyl methylcellulose and the Mentholum of recipe quantity and the polyvinylpolypyrrolidone of 1/2 recipe quantity again, cross 80 mesh sieves; Add volume fraction again and be 60% ethanol water and make soft material in right amount, 24 mesh sieves are granulated, 60 ± 5 ℃ of dryings, and dried granule is crossed 24 mesh sieve granulate; The sodium bicarbonate, magnesium stearate and the aspartame that in dried granule, add residue polyvinylpolypyrrolidone and recipe quantity again, mixing, tabletting is processed 1000 of carbazochrome sodium sulfonate oral disintegrating tablets altogether, and every contains carbazochrome sodium sulfonate 10mg.
Quality gained oral cavity disintegration tablet any surface finish, attractive in appearance; Hardness is 25～28 Ns and pauses; 30 mesh sieves are also passed through in complete disintegrate in 28 seconds in 37 ± 1 ℃ of water; Cool taste, sweetness, exquisiteness, no grittiness.
The dissolution of carbazochrome sodium sulfonate oral disintegrating tablets of the present invention and commercially available carbazochrome sodium sulfonate ordinary tablet relatively
Method: getting the carbazochrome sodium sulfonate oral disintegrating tablets of various embodiments of the present invention preparation and commercially available carbazochrome sodium sulfonate ordinary tablet respectively, is dissolution medium with water 900mL, and rotating speed is that per minute 50 changes; According to two appendix XC second method operations of Chinese Pharmacopoeia version in 2005, in the time of 1,5,10,15,20,25,30,45 minute, get solution 5mL respectively; Filter; Get subsequent filtrate as need testing solution, measure trap at wavelength 363nm place, press C
10H
11N
4O
5Absorptance (the E of SNa
1%1 Cm) be 862 calculating dissolutions.The result sees the following form.Visible by table, to compare with commercially available carbazochrome sodium sulfonate ordinary tablet, carbazochrome sodium sulfonate oral disintegrating tablets of the present invention has characteristics such as disintegrate is fast, stripping is fast, dissolution height.
The dissolution of table carbazochrome sodium sulfonate oral disintegrating tablets and carbazochrome sodium sulfonate ordinary tablet relatively
Explanation is at last; Above embodiment is only unrestricted in order to technical scheme of the present invention to be described; Although through invention has been described with reference to the preferred embodiments of the present invention; But those of ordinary skill in the art should be appreciated that and can make various changes to it in form with on the details, and the spirit and scope of the present invention that do not depart from appended claims and limited.
Claims (4)
1. carbazochrome sodium sulfonate oral disintegrating tablets is characterized in that: composed of the following components by mass percentage: carbazochrome sodium sulfonate 8%～9%, filler 74%～80%, disintegrating agent 6%～12%, binding agent 3%～5%, lubricant 0.4%～0.5% and correctives 0.4%～1%; Said filler is starch, mannitol and microcrystalline Cellulose; Said disintegrating agent is polyvinylpolypyrrolidone or polyvinylpolypyrrolidone and gas-producing disintegrant, and gas-producing disintegrant is made up of citric acid and sodium bicarbonate; Said binding agent is a hydroxypropyl methylcellulose; Said lubricant is a magnesium stearate; Said correctives is Mentholum or Mentholum and aspartame.
2. the method for preparing of the described carbazochrome sodium sulfonate oral disintegrating tablets of claim 1 is characterized in that: adopt the wet granule compression tablet method, may further comprise the steps:
A, pulverizing: filler, disintegrating agent, binding agent, lubricant and correctives pulverize separately are become the fine powder of fineness more than 100 orders;
B, granulation: with carbazochrome sodium sulfonate and partially filled dose of mixing, pulverize, cross 80 mesh sieves; Again with the residue filler, in disintegrating agent, binding agent, in add the correctives mixing, cross 80 mesh sieves; Add wetting agent system soft material again, 20～40 mesh sieves are granulated, 60 ± 5 ℃ of dryings, and dried granule is crossed 20～60 mesh sieve granulate;
C, tabletting: with the dried granule behind the step b granulate with add disintegrating agent, lubricant, add the correctives mixing, tabletting promptly gets carbazochrome sodium sulfonate oral disintegrating tablets.
3. the method for preparing of carbazochrome sodium sulfonate oral disintegrating tablets according to claim 2, it is characterized in that: the wetting agent among the said step b is that volume fraction is 60% ethanol water.
4. the method for preparing of carbazochrome sodium sulfonate oral disintegrating tablets according to claim 2 is characterized in that: adopt 24 mesh sieves to granulate among the said step b, dried granule is crossed 24 mesh sieve granulate.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1985808A (en) * | 2006-12-20 | 2007-06-27 | 山东省医药工业研究所 | Carbazochrome sodium sulfonate slow-released tablet and its preparing method |
| CN101554377A (en) * | 2008-04-09 | 2009-10-14 | 鲁南制药集团股份有限公司 | Pharmaceutical composition containing prasugrel and carbazochrome sodium sulfonate |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1985808A (en) * | 2006-12-20 | 2007-06-27 | 山东省医药工业研究所 | Carbazochrome sodium sulfonate slow-released tablet and its preparing method |
| CN101554377A (en) * | 2008-04-09 | 2009-10-14 | 鲁南制药集团股份有限公司 | Pharmaceutical composition containing prasugrel and carbazochrome sodium sulfonate |
Non-Patent Citations (1)
| Title |
|---|
| 贾伟、高文远，主编.口腔崩解片.《药物控释新剂型》.化学工业出版社、现代生物技术与医药科技出版中心,2005,(第1版),8-15. * |
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