CN101180046A - 含有屈昔多巴的稳定片剂 - Google Patents
含有屈昔多巴的稳定片剂 Download PDFInfo
- Publication number
- CN101180046A CN101180046A CNA2006800172020A CN200680017202A CN101180046A CN 101180046 A CN101180046 A CN 101180046A CN A2006800172020 A CNA2006800172020 A CN A2006800172020A CN 200680017202 A CN200680017202 A CN 200680017202A CN 101180046 A CN101180046 A CN 101180046A
- Authority
- CN
- China
- Prior art keywords
- tablet
- starch
- corn
- droxidopa
- described tablet
- 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.)
- Granted
Links
- 229960001104 droxidopa Drugs 0.000 title claims abstract description 65
- QXWYKJLNLSIPIN-SFYZADRCSA-N droxidopa Chemical compound OC(=O)[C@H](N)[C@@H](O)C1=CC=C(O)C(O)=C1 QXWYKJLNLSIPIN-SFYZADRCSA-N 0.000 title claims abstract 10
- 238000002360 preparation method Methods 0.000 claims abstract description 51
- 229920002472 Starch Polymers 0.000 claims abstract description 49
- 239000008107 starch Substances 0.000 claims abstract description 49
- 235000019698 starch Nutrition 0.000 claims abstract description 49
- 239000011230 binding agent Substances 0.000 claims abstract description 47
- 235000002017 Zea mays subsp mays Nutrition 0.000 claims abstract description 44
- 235000005824 Zea mays ssp. parviglumis Nutrition 0.000 claims abstract description 43
- 235000005822 corn Nutrition 0.000 claims abstract description 43
- 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 33
- 229920002451 polyvinyl alcohol Polymers 0.000 claims abstract description 32
- 239000004372 Polyvinyl alcohol Substances 0.000 claims abstract description 31
- 239000000546 pharmaceutical excipient Substances 0.000 claims abstract description 29
- 235000010355 mannitol Nutrition 0.000 claims abstract description 25
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims abstract description 17
- 229930195725 Mannitol Natural products 0.000 claims abstract description 17
- 239000008101 lactose Substances 0.000 claims abstract description 17
- 239000000594 mannitol Substances 0.000 claims abstract description 17
- 239000004386 Erythritol Substances 0.000 claims abstract description 15
- UNXHWFMMPAWVPI-UHFFFAOYSA-N Erythritol Natural products OCC(O)C(O)CO UNXHWFMMPAWVPI-UHFFFAOYSA-N 0.000 claims abstract description 15
- 235000019414 erythritol Nutrition 0.000 claims abstract description 15
- UNXHWFMMPAWVPI-ZXZARUISSA-N erythritol Chemical compound OC[C@H](O)[C@H](O)CO UNXHWFMMPAWVPI-ZXZARUISSA-N 0.000 claims abstract description 15
- 229940009714 erythritol Drugs 0.000 claims abstract description 15
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims abstract description 13
- 229930006000 Sucrose Natural products 0.000 claims abstract description 13
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims abstract description 12
- 239000005720 sucrose Substances 0.000 claims abstract description 12
- 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 claims abstract description 11
- 239000008103 glucose Substances 0.000 claims abstract description 11
- 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 claims abstract description 9
- 239000008120 corn starch Substances 0.000 claims description 60
- 229920002261 Corn starch Polymers 0.000 claims description 59
- 240000008042 Zea mays Species 0.000 claims description 42
- 238000000034 method Methods 0.000 claims description 33
- 239000000203 mixture Substances 0.000 claims description 29
- 210000000214 mouth Anatomy 0.000 claims description 28
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 27
- 229920000881 Modified starch Polymers 0.000 claims description 18
- 238000005469 granulation Methods 0.000 claims description 13
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- 241000209149 Zea Species 0.000 abstract 2
- 239000004480 active ingredient Substances 0.000 abstract 2
- QXWYKJLNLSIPIN-JGVFFNPUSA-N droxidopa Chemical compound OC(=O)[C@@H](N)[C@H](O)C1=CC=C(O)C(O)=C1 QXWYKJLNLSIPIN-JGVFFNPUSA-N 0.000 description 62
- 229940099112 cornstarch Drugs 0.000 description 55
- 238000004519 manufacturing process Methods 0.000 description 22
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 18
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 13
- 230000004075 alteration Effects 0.000 description 13
- 239000000741 silica gel Substances 0.000 description 13
- 229910002027 silica gel Inorganic materials 0.000 description 13
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 10
- 239000007788 liquid Substances 0.000 description 10
- 239000002245 particle Substances 0.000 description 10
- 239000000314 lubricant Substances 0.000 description 9
- 235000019359 magnesium stearate Nutrition 0.000 description 9
- 239000011521 glass Substances 0.000 description 8
- 239000006185 dispersion Substances 0.000 description 7
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- MVPICKVDHDWCJQ-UHFFFAOYSA-N ethyl 3-pyrrolidin-1-ylpropanoate Chemical compound CCOC(=O)CCN1CCCC1 MVPICKVDHDWCJQ-UHFFFAOYSA-N 0.000 description 6
- 238000011156 evaluation Methods 0.000 description 6
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- 229940045902 sodium stearyl fumarate Drugs 0.000 description 6
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- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 description 5
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 description 4
- TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 description 4
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- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 description 4
- 229920000609 methyl cellulose Polymers 0.000 description 4
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- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 4
- STFSJTPVIIDAQX-LTRPLHCISA-M sodium;(e)-4-octadecoxy-4-oxobut-2-enoate Chemical compound [Na+].CCCCCCCCCCCCCCCCCCOC(=O)\C=C\C([O-])=O STFSJTPVIIDAQX-LTRPLHCISA-M 0.000 description 4
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- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 description 3
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- 239000004570 mortar (masonry) Substances 0.000 description 3
- 238000010298 pulverizing process Methods 0.000 description 3
- HDTRYLNUVZCQOY-UHFFFAOYSA-N α-D-glucopyranosyl-α-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OC1C(O)C(O)C(O)C(CO)O1 HDTRYLNUVZCQOY-UHFFFAOYSA-N 0.000 description 2
- 229920001817 Agar Polymers 0.000 description 2
- 240000004307 Citrus medica Species 0.000 description 2
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 description 2
- 108010010803 Gelatin Proteins 0.000 description 2
- 208000027089 Parkinsonian disease Diseases 0.000 description 2
- 206010034010 Parkinsonism Diseases 0.000 description 2
- HDTRYLNUVZCQOY-WSWWMNSNSA-N Trehalose Natural products O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-WSWWMNSNSA-N 0.000 description 2
- 239000008272 agar Substances 0.000 description 2
- 235000010419 agar Nutrition 0.000 description 2
- HDTRYLNUVZCQOY-LIZSDCNHSA-N alpha,alpha-trehalose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-LIZSDCNHSA-N 0.000 description 2
- 150000008064 anhydrides Chemical class 0.000 description 2
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- 235000019322 gelatine Nutrition 0.000 description 2
- 235000011852 gelatine desserts Nutrition 0.000 description 2
- 238000011835 investigation Methods 0.000 description 2
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- 229920001592 potato starch Polymers 0.000 description 2
- 239000008213 purified water Substances 0.000 description 2
- 230000009467 reduction Effects 0.000 description 2
- 229940100486 rice starch Drugs 0.000 description 2
- 238000007127 saponification reaction Methods 0.000 description 2
- 229960002920 sorbitol Drugs 0.000 description 2
- 238000001228 spectrum Methods 0.000 description 2
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- 230000000007 visual effect Effects 0.000 description 2
- OWEGMIWEEQEYGQ-UHFFFAOYSA-N 100676-05-9 Natural products OC1C(O)C(O)C(CO)OC1OCC1C(O)C(O)C(O)C(OC2C(OC(O)C(O)C2O)CO)O1 OWEGMIWEEQEYGQ-UHFFFAOYSA-N 0.000 description 1
- 206010061818 Disease progression Diseases 0.000 description 1
- 244000024675 Eruca sativa Species 0.000 description 1
- 235000014755 Eruca sativa Nutrition 0.000 description 1
- IMROMDMJAWUWLK-UHFFFAOYSA-N Ethenol Chemical compound OC=C IMROMDMJAWUWLK-UHFFFAOYSA-N 0.000 description 1
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- 229920003114 HPC-L Polymers 0.000 description 1
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- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 description 1
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- 229920003072 Plasdone™ povidone Polymers 0.000 description 1
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- LKDRXBCSQODPBY-ZXXMMSQZSA-N alpha-D-fructopyranose Chemical compound OC[C@]1(O)OC[C@@H](O)[C@@H](O)[C@@H]1O LKDRXBCSQODPBY-ZXXMMSQZSA-N 0.000 description 1
- 230000002421 anti-septic effect Effects 0.000 description 1
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- 230000003078 antioxidant effect Effects 0.000 description 1
- 238000009835 boiling Methods 0.000 description 1
- CJZGTCYPCWQAJB-UHFFFAOYSA-L calcium stearate Chemical compound [Ca+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O CJZGTCYPCWQAJB-UHFFFAOYSA-L 0.000 description 1
- 239000008116 calcium stearate Substances 0.000 description 1
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- 235000014113 dietary fatty acids Nutrition 0.000 description 1
- 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 1
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- 235000009973 maize Nutrition 0.000 description 1
- VQHSOMBJVWLPSR-WUJBLJFYSA-N maltitol Chemical compound OC[C@H](O)[C@@H](O)[C@@H]([C@H](O)CO)O[C@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O VQHSOMBJVWLPSR-WUJBLJFYSA-N 0.000 description 1
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- 239000002105 nanoparticle Substances 0.000 description 1
- 231100000862 numbness Toxicity 0.000 description 1
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 description 1
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 description 1
- 150000007524 organic acids Chemical class 0.000 description 1
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- 239000008117 stearic acid Substances 0.000 description 1
- 238000003756 stirring Methods 0.000 description 1
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- 239000000725 suspension Substances 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
- A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
- A61P25/16—Anti-Parkinson drugs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Neurology (AREA)
- Biomedical Technology (AREA)
- Organic Chemistry (AREA)
- Neurosurgery (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Heart & Thoracic Surgery (AREA)
- Cardiology (AREA)
- Psychology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
Description
制剂1 | 投料量(kg) |
L-threo DOPS | 14.5 |
D-甘露醇1 | 13.05 |
玉米淀粉2 | 1.43 |
St-Mg3 | 微量 |
样品 | 评价 | 初始值 | 60℃×1M | 40℃×1M | 40℃×3M | 40℃×6M | 25℃×3M |
制剂1 | 外观判断 | - | + | ± | ± | ± | - |
色调 | 白色 | 淡褐色 | 淡褐色 | 淡褐色 | 淡褐色 | 白色 | |
色差(ΔE) | 0.00 | 6.51 | 1.02 | 1.70 | 2.09 | 0.6 | |
水份含量(%) | n.d. | 0.64 | n.d. | 0.55 | n.d. | 0.48 | |
制剂1+硅胶 | 外观判断 | - | ± | - | - | - | - |
色调 | 白色 | 淡褐色 | 白色 | 白色 | 白色 | 白色 | |
色差(ΔE) | 0.00 | 2.37 | 0.41 | 0.78 | 0.80 | 0.26 | |
水份含量(%) | n.d. | 0.39 | n.d. | 0.27 | n.d. | 0.27 |
样品 | 刚压片后 | 25℃×3M | 40℃×3M |
制剂1 | 100.0 | 101.7 | 101.9 |
制剂1+硅胶 | 100.0 | 102.0 | 99.7 |
成分 | 每片量(mg) |
L-threo DOPS | 200 |
木糖醇8 | 180 |
甲基纤维素9 | 20 |
硬脂酸镁3 | 微量 |
样品 | 评价 | 初始值 | 40℃×1M |
制剂1 | 外观判断 | - | ± |
色调 | 白色 | 淡褐色 | |
比较例 | 外观判断 | - | ++ |
色调 | 白色 | 部分变黑 |
制剂2 | 投料量(g) |
L-threo DOPS | 600 |
D-甘露醇1 | 540 |
玉米淀粉2 | 60 |
PRUV5 | 36 |
制剂3 | 每片量(mg) |
L-threo DOPS乳糖6预胶化淀粉7St-Mg3 | 2009010微量 |
No. | 添加剂 | 60℃×2W色差 | 40℃75%×2W潮解 |
1 | D-甘露醇1 | 0.72 | 无 |
2 | 乳糖6 | 1.74 | 无 |
3 | 赤藓糖醇14 | 2.65 | 无 |
4 | 葡萄糖15 | 2.39 | 无 |
5 | 蔗糖16 | 1.30 | 无 |
6 | 结晶纤维素17 | 3.81 | 无 |
7 | 预胶化淀粉(来源于玉米的)7 | 3.47 | 无 |
8 | 部分预胶化淀粉(来源于玉米的)18 | 3.50 | 无 |
9 | 玉米淀粉2 | 2.83 | 无 |
10 | 羟丙基淀粉19 | 7.12 | n.d. |
11 | 木糖醇8 | 1.35 | 潮解 |
12 | D-山梨醇20 | 3.83 | 潮解 |
13 | 海藻糖21 | 5.14 | n.d. |
14 | multitol 22 | 5.06 | n.d. |
15 | 果糖23 | 6.94 | n.d. |
16 | 马铃薯淀粉24 | 7.52 | n.d. |
17 | 米淀粉25 | 8.51 | n.d. |
18 | 仅屈昔多巴(无崩解剂) | 2.73 | n.d. |
No. | 添加剂 | 60℃×2W色差 | 40℃75%×2W潮解 |
1 | 聚乙烯醇26 | 3.27 | 无 |
2 | 聚乙烯吡咯烷酮27 | 4.63 | n.d. |
3 | 羟丙纤维素28 | 9.67 | n.d. |
4 | 羟丙基甲基纤维素29 | 13.72 | n.d. |
5 | 甲基纤维素9 | 17.83 | n.d. |
6 | 仅屈昔多巴(无粘合剂) | 2.73 | n.d. |
每片处方 | 制剂4(mg) | 制剂5(mg) |
L-threo DOPS | 200 | 200 |
D-甘露醇1 | 180 | 176 |
玉米淀粉2 | 20 | 20 |
枸橼酸酐12 | 0 | 2 |
天冬甜素13 | 0 | 2 |
St-Mg3 | 微量 | 微量 |
总计 | 400 | 400 |
制剂例 | 原药平均粒径(μm) | 原药90%D(μm) | 口感(粉末性)(得分) | 容易服用性(得分) | 制备时的操作(制造性) | 颗粒的休止角 |
4 | 48 | 154 | 2.5 | 2.9 | 良好 | 39° |
4 | 39 | 138 | 2.7 | n.d. | 良好 | 39° |
4 | 10 | 34 | 3.3 | n.d. | 差 | 43 ° |
5 | 39 | 138 | 3.1 | 3.7 | n.d. | n.d. |
5 | 25 | 80 | n.d. | n.d. | 良好 | 39° |
粉末性评价得分 | |
无感觉 | 4 |
不厌烦 | 3 |
稍微厌烦 | 2 |
厌烦 | 1 |
容易服用性评价得分 | |
可无问题地服用 | 4 |
可以正常服用 | 3 |
通过一些努力可以服用 | 2 |
服用困难 | 1 |
样品 | 评价 | 初始值 | 60℃×2W |
制剂4(+硅胶) | 判断 | - | ± |
色调 | 白色 | 淡褐色 | |
色差(ΔE) | 0.00 | 1.53 | |
制剂5(+硅胶) | 判断 | - | ± |
色调 | 白色 | 淡褐色 | |
色差(ΔE) | 0.00 | 1.78 |
每片处方 | 制剂6 | 制剂7 |
L-threo DOPSD-甘露醇1玉米淀粉2PVA26St-Mg3 | 2001651916微量 | 200172204微量 |
总计 | 400 | 396 |
样品 | 评价 | 初始值 | 60℃×2W |
制剂6(+硅胶) | 判断 | - | ± |
色调 | 白色 | 淡褐色 | |
色差(ΔE) | 0.00 | 1.75 | |
制剂7(+硅胶) | 判断 | - | ± |
色调 | 白色 | 淡褐色 | |
色差(ΔE) | 0.00 | 1.68 |
Claims (22)
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JP (2) | JP5219508B2 (zh) |
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CN (1) | CN101180046B (zh) |
CA (1) | CA2608690C (zh) |
DK (1) | DK1886678T3 (zh) |
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CN103282051A (zh) * | 2010-12-28 | 2013-09-04 | 大鹏药品工业株式会社 | 口腔内崩解片剂 |
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Cited By (4)
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CN102119034B (zh) * | 2008-06-13 | 2013-05-22 | 大日本住友制药株式会社 | 在口腔中快速崩解的片剂和制备其的方法 |
CN103282051A (zh) * | 2010-12-28 | 2013-09-04 | 大鹏药品工业株式会社 | 口腔内崩解片剂 |
WO2013167998A3 (en) * | 2012-05-10 | 2016-09-01 | Cellixbio Private Limited | Compositions and methods for the treatment of autonomic and other neurological disorders |
CN109414051A (zh) * | 2016-06-28 | 2019-03-01 | 株式会社日本抗菌总和研究所 | 赋形剂和片剂 |
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WO2006123678A1 (ja) | 2006-11-23 |
CA2608690A1 (en) | 2006-11-23 |
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EP1886678A1 (en) | 2008-02-13 |
CN101180046B (zh) | 2011-12-28 |
JP5219508B2 (ja) | 2013-06-26 |
EP1886678B1 (en) | 2017-04-19 |
CA2608690C (en) | 2016-07-05 |
EP1886678A4 (en) | 2009-06-10 |
US20090074861A1 (en) | 2009-03-19 |
JP5219924B2 (ja) | 2013-06-26 |
ES2633088T3 (es) | 2017-09-19 |
JP2009185083A (ja) | 2009-08-20 |
US8980316B2 (en) | 2015-03-17 |
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