CN1520292A - 药物组合物 - Google Patents
药物组合物 Download PDFInfo
- Publication number
- CN1520292A CN1520292A CNA028106520A CN02810652A CN1520292A CN 1520292 A CN1520292 A CN 1520292A CN A028106520 A CNA028106520 A CN A028106520A CN 02810652 A CN02810652 A CN 02810652A CN 1520292 A CN1520292 A CN 1520292A
- Authority
- CN
- China
- Prior art keywords
- acid
- sodium
- powder
- pharmaceutical composition
- fudosteine
- 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
- KINWYTAUPKOPCQ-YFKPBYRVSA-N Fudosteine Chemical compound OC(=O)[C@@H](N)CSCCCO KINWYTAUPKOPCQ-YFKPBYRVSA-N 0.000 claims abstract description 56
- 229950006783 fudosteine Drugs 0.000 claims abstract description 55
- 230000000202 analgesic effect Effects 0.000 claims abstract description 39
- 239000000203 mixture Substances 0.000 claims abstract description 33
- RZVAJINKPMORJF-UHFFFAOYSA-N Acetaminophen Chemical compound CC(=O)NC1=CC=C(O)C=C1 RZVAJINKPMORJF-UHFFFAOYSA-N 0.000 claims description 52
- 239000008194 pharmaceutical composition Substances 0.000 claims description 37
- 239000003814 drug Substances 0.000 claims description 33
- 229960005489 paracetamol Drugs 0.000 claims description 26
- 229940079593 drug Drugs 0.000 claims description 21
- HEFNNWSXXWATRW-UHFFFAOYSA-N Ibuprofen Chemical compound CC(C)CC1=CC=C(C(C)C(O)=O)C=C1 HEFNNWSXXWATRW-UHFFFAOYSA-N 0.000 claims description 19
- 229960001680 ibuprofen Drugs 0.000 claims description 19
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical class [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 claims description 17
- 206010011224 Cough Diseases 0.000 claims description 6
- WVYADZUPLLSGPU-UHFFFAOYSA-N salsalate Chemical compound OC(=O)C1=CC=CC=C1OC(=O)C1=CC=CC=C1O WVYADZUPLLSGPU-UHFFFAOYSA-N 0.000 claims description 6
- ABBQHOQBGMUPJH-UHFFFAOYSA-M Sodium salicylate Chemical compound [Na+].OC1=CC=CC=C1C([O-])=O ABBQHOQBGMUPJH-UHFFFAOYSA-M 0.000 claims description 5
- 230000001387 anti-histamine Effects 0.000 claims description 5
- 239000000739 antihistaminic agent Substances 0.000 claims description 5
- 229960000514 ethenzamide Drugs 0.000 claims description 5
- SBNKFTQSBPKMBZ-UHFFFAOYSA-N ethenzamide Chemical compound CCOC1=CC=CC=C1C(N)=O SBNKFTQSBPKMBZ-UHFFFAOYSA-N 0.000 claims description 5
- 229960004025 sodium salicylate Drugs 0.000 claims description 5
- 229940088594 vitamin Drugs 0.000 claims description 5
- 229930003231 vitamin Natural products 0.000 claims description 5
- 235000013343 vitamin Nutrition 0.000 claims description 5
- 239000011782 vitamin Substances 0.000 claims description 5
- 150000003722 vitamin derivatives Chemical class 0.000 claims description 5
- MANKSFVECICGLK-UHFFFAOYSA-K aloxiprin Chemical compound [OH-].[Al+3].CC(=O)OC1=CC=CC=C1C([O-])=O.CC(=O)OC1=CC=CC=C1C([O-])=O MANKSFVECICGLK-UHFFFAOYSA-K 0.000 claims description 4
- 229940069428 antacid Drugs 0.000 claims description 4
- 239000003159 antacid agent Substances 0.000 claims description 4
- 230000001458 anti-acid effect Effects 0.000 claims description 4
- 210000004877 mucosa Anatomy 0.000 claims description 4
- 239000003223 protective agent Substances 0.000 claims description 4
- SKZKKFZAGNVIMN-UHFFFAOYSA-N Salicilamide Chemical compound NC(=O)C1=CC=CC=C1O SKZKKFZAGNVIMN-UHFFFAOYSA-N 0.000 claims description 3
- 229960001138 acetylsalicylic acid Drugs 0.000 claims description 3
- 239000002269 analeptic agent Substances 0.000 claims description 3
- 230000003555 analeptic effect Effects 0.000 claims description 3
- 238000009472 formulation Methods 0.000 claims description 3
- GHZNWXGYWUBLLI-UHFFFAOYSA-N p-Lactophenetide Chemical compound CCOC1=CC=C(NC(=O)C(C)O)C=C1 GHZNWXGYWUBLLI-UHFFFAOYSA-N 0.000 claims description 3
- PXWLVJLKJGVOKE-UHFFFAOYSA-N propyphenazone Chemical compound O=C1C(C(C)C)=C(C)N(C)N1C1=CC=CC=C1 PXWLVJLKJGVOKE-UHFFFAOYSA-N 0.000 claims description 3
- 229960002189 propyphenazone Drugs 0.000 claims description 3
- 229960000581 salicylamide Drugs 0.000 claims description 3
- 229960000953 salsalate Drugs 0.000 claims description 3
- 150000001875 compounds Chemical class 0.000 claims description 2
- 230000003110 anti-inflammatory effect Effects 0.000 abstract description 3
- 201000009240 nasopharyngitis Diseases 0.000 abstract description 3
- 206010036790 Productive cough Diseases 0.000 abstract 1
- 230000001754 anti-pyretic effect Effects 0.000 abstract 1
- 239000002221 antipyretic Substances 0.000 abstract 1
- 208000024794 sputum Diseases 0.000 abstract 1
- -1 hydroxypropyl Chemical group 0.000 description 104
- 239000000843 powder Substances 0.000 description 88
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 63
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 46
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 44
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 43
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 description 39
- 238000000034 method Methods 0.000 description 37
- 239000003826 tablet Substances 0.000 description 34
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 description 33
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 33
- 238000002360 preparation method Methods 0.000 description 31
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- 229920003171 Poly (ethylene oxide) Polymers 0.000 description 30
- 229920002472 Starch Polymers 0.000 description 29
- 239000008107 starch Substances 0.000 description 29
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- 235000012239 silicon dioxide Nutrition 0.000 description 28
- 235000019698 starch Nutrition 0.000 description 28
- 239000000194 fatty acid Substances 0.000 description 27
- 229930006000 Sucrose Natural products 0.000 description 26
- 239000000243 solution Substances 0.000 description 26
- 229960004793 sucrose Drugs 0.000 description 26
- 235000014113 dietary fatty acids Nutrition 0.000 description 24
- 229930195729 fatty acid Natural products 0.000 description 24
- ZEMPKEQAKRGZGQ-AAKVHIHISA-N 2,3-bis[[(z)-12-hydroxyoctadec-9-enoyl]oxy]propyl (z)-12-hydroxyoctadec-9-enoate Chemical compound CCCCCCC(O)C\C=C/CCCCCCCC(=O)OCC(OC(=O)CCCCCCC\C=C/CC(O)CCCCCC)COC(=O)CCCCCCC\C=C/CC(O)CCCCCC ZEMPKEQAKRGZGQ-AAKVHIHISA-N 0.000 description 23
- 239000008187 granular material Substances 0.000 description 23
- 239000003921 oil Substances 0.000 description 23
- 235000019198 oils Nutrition 0.000 description 23
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 22
- 235000020357 syrup Nutrition 0.000 description 22
- 239000006188 syrup Substances 0.000 description 22
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 21
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 description 20
- 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 19
- 239000011734 sodium Substances 0.000 description 19
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 description 18
- 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 18
- 239000003795 chemical substances by application Substances 0.000 description 18
- 230000003419 expectorant effect Effects 0.000 description 18
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 description 18
- 239000001863 hydroxypropyl cellulose Substances 0.000 description 18
- 229940071676 hydroxypropylcellulose Drugs 0.000 description 18
- 239000005720 sucrose Substances 0.000 description 18
- 235000011187 glycerol Nutrition 0.000 description 17
- 229960005150 glycerol Drugs 0.000 description 17
- 239000004615 ingredient Substances 0.000 description 17
- 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 16
- VZCYOOQTPOCHFL-OWOJBTEDSA-N Fumaric acid Chemical compound OC(=O)\C=C\C(O)=O VZCYOOQTPOCHFL-OWOJBTEDSA-N 0.000 description 16
- 229910000323 aluminium silicate Inorganic materials 0.000 description 16
- 210000000582 semen Anatomy 0.000 description 16
- 235000015424 sodium Nutrition 0.000 description 16
- 229940083542 sodium Drugs 0.000 description 16
- 229910052708 sodium Inorganic materials 0.000 description 16
- 229960002920 sorbitol Drugs 0.000 description 16
- 229920002261 Corn starch Polymers 0.000 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 description 15
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 15
- 239000008120 corn starch Substances 0.000 description 15
- 235000019441 ethanol Nutrition 0.000 description 15
- 239000007788 liquid Substances 0.000 description 15
- 229960003511 macrogol Drugs 0.000 description 15
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 description 14
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 description 14
- 239000000654 additive Substances 0.000 description 14
- 238000000576 coating method Methods 0.000 description 14
- 238000007796 conventional method Methods 0.000 description 14
- 235000011167 hydrochloric acid Nutrition 0.000 description 14
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 description 14
- 235000002639 sodium chloride Nutrition 0.000 description 14
- 239000000454 talc Substances 0.000 description 14
- 235000012222 talc Nutrition 0.000 description 14
- 229910052623 talc Inorganic materials 0.000 description 14
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 14
- 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 13
- AUNGANRZJHBGPY-SCRDCRAPSA-N Riboflavin Chemical compound OC[C@@H](O)[C@@H](O)[C@@H](O)CN1C=2C=C(C)C(C)=CC=2N=C2C1=NC(=O)NC2=O AUNGANRZJHBGPY-SCRDCRAPSA-N 0.000 description 13
- 235000010980 cellulose Nutrition 0.000 description 13
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- 239000001913 cellulose Substances 0.000 description 13
- 229960004756 ethanol Drugs 0.000 description 13
- 238000007670 refining Methods 0.000 description 13
- VBICKXHEKHSIBG-UHFFFAOYSA-N 1-monostearoylglycerol Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCC(O)CO VBICKXHEKHSIBG-UHFFFAOYSA-N 0.000 description 12
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 description 12
- 108010010803 Gelatin Proteins 0.000 description 12
- RYYVLZVUVIJVGH-UHFFFAOYSA-N caffeine Chemical compound CN1C(=O)N(C)C(=O)C2=C1N=CN2C RYYVLZVUVIJVGH-UHFFFAOYSA-N 0.000 description 12
- 229920001577 copolymer Polymers 0.000 description 12
- 239000008273 gelatin Substances 0.000 description 12
- 229920000159 gelatin Polymers 0.000 description 12
- 235000019322 gelatine Nutrition 0.000 description 12
- 235000011852 gelatine desserts Nutrition 0.000 description 12
- WGCNASOHLSPBMP-UHFFFAOYSA-N hydroxyacetaldehyde Natural products OCC=O WGCNASOHLSPBMP-UHFFFAOYSA-N 0.000 description 12
- JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical compound CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 description 12
- 229920001451 polypropylene glycol Polymers 0.000 description 12
- VZCYOOQTPOCHFL-UHFFFAOYSA-N trans-butenedioic acid Natural products OC(=O)C=CC(O)=O VZCYOOQTPOCHFL-UHFFFAOYSA-N 0.000 description 12
- FMCGSUUBYTWNDP-ONGXEEELSA-N (1R,2S)-2-(dimethylamino)-1-phenyl-1-propanol Chemical compound CN(C)[C@@H](C)[C@H](O)C1=CC=CC=C1 FMCGSUUBYTWNDP-ONGXEEELSA-N 0.000 description 11
- 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 11
- 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 11
- FMCGSUUBYTWNDP-UHFFFAOYSA-N N-Methylephedrine Natural products CN(C)C(C)C(O)C1=CC=CC=C1 FMCGSUUBYTWNDP-UHFFFAOYSA-N 0.000 description 11
- 229920002125 Sokalan® Polymers 0.000 description 11
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- FUFJGUQYACFECW-UHFFFAOYSA-L calcium hydrogenphosphate Chemical compound [Ca+2].OP([O-])([O-])=O FUFJGUQYACFECW-UHFFFAOYSA-L 0.000 description 11
- 239000002775 capsule Substances 0.000 description 11
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- 239000008101 lactose Substances 0.000 description 11
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- JLPULHDHAOZNQI-ZTIMHPMXSA-N 1-hexadecanoyl-2-(9Z,12Z-octadecadienoyl)-sn-glycero-3-phosphocholine Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@H](COP([O-])(=O)OCC[N+](C)(C)C)OC(=O)CCCCCCC\C=C/C\C=C/CCCCC JLPULHDHAOZNQI-ZTIMHPMXSA-N 0.000 description 10
- 206010062717 Increased upper airway secretion Diseases 0.000 description 10
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- CDBYLPFSWZWCQE-UHFFFAOYSA-L Sodium Carbonate Chemical compound [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 description 10
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- GLDOVTGHNKAZLK-UHFFFAOYSA-N octadecan-1-ol Chemical compound CCCCCCCCCCCCCCCCCCO GLDOVTGHNKAZLK-UHFFFAOYSA-N 0.000 description 10
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- 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 9
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- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 description 7
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- VMYFZRTXGLUXMZ-UHFFFAOYSA-N triethyl citrate Natural products CCOC(=O)C(O)(C(=O)OCC)C(=O)OCC VMYFZRTXGLUXMZ-UHFFFAOYSA-N 0.000 description 1
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- NCYCYZXNIZJOKI-UHFFFAOYSA-N vitamin A aldehyde Natural products O=CC=C(C)C=CC=C(C)C=CC1=C(C)CCCC1(C)C NCYCYZXNIZJOKI-UHFFFAOYSA-N 0.000 description 1
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Classifications
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- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
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- A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
- A61K31/166—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the carbon of a carboxamide group directly attached to the aromatic ring, e.g. procainamide, procarbazine, metoclopramide, labetalol
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- A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- 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
- A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid
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- 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]
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- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/415—1,2-Diazoles
- A61K31/4152—1,2-Diazoles having oxo groups directly attached to the heterocyclic ring, e.g. antipyrine, phenylbutazone, sulfinpyrazone
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Abstract
本发明提供了以包含弗多司坦和解热/镇痛药为特征的药物组合物。这些药物组合物是可用于治疗普通感冒等疾病的药物组合物,并具有较好的祛痰和抗炎效果。
Description
技术领域
本发明涉及一种药物组合物,更具体地说,本发明涉及一种具有极好的祛痰和抗炎作用的药物组合物,所述的药物组合物可有利地用作感冒药等药物。
背景技术
以往有许多感冒用药物组合物已经商品化。为了达到抑制或缓解各感冒症状的目的,除在该类组合物中添加解热/镇痛药之外通常还会添加一些其他成分。
例如,因感冒而引发支气管炎等炎症时,大多数情况下会有咳嗽和多痰等症状,所以感冒用药物组合物中可以加入具有祛痰作用的药用成分。但是,以往添加到常规感冒用药物组合物中的具有祛痰作用的祛痰药,祛痰效果差而不能令人满意。
痰粘住喉咙,会给感冒患者造成痛苦,并会过分消耗其体力,所以需要开发具有更好的祛痰作用的感冒药等药物组合物。
发明内容
为了得到具有优良祛痰作用的感冒用药物组合物,本发明人研究了公知的祛痰药与添加到药物组合物中的其他成分的组合的疗效,他们发现,因合用作为祛痰药的弗多司坦(fudostein)和解热/镇痛药,含有弗多司坦的感冒用药物组合物增强了祛痰作用和抗炎作用。这个发现使本发明得以完成。
具体而言,本发明提供了以包含弗多司坦和解热/镇痛药为特征的药物组合物。
具体实施方式
在本发明的药物组合物中加入弗多司坦和解热/镇痛药作为必要的药用成分。
本发明所用的弗多司坦是由以下通式(I)表示的S-(3-羟基丙基)-L-半胱氨酸,在日本特开平2-3674号中已报道该化合物可以用作祛痰药。
然而,所述添加了弗多司坦和解热/镇痛药的药物组合物尚属未知。
本发明的药物组合物中,可使用所述弗多司坦或其盐类,例如弗多司坦的无机酸盐、有机酸盐、碱金属盐或碱土金属盐等。
在本发明的药物组合物中,虽然对弗多司坦或其盐类的添加用量没有特别的限制,但通常情况下,成人的剂量为约12~2,400毫克/天,更优选约40~1,200毫克/天。
本发明的药物组合物中所用的解热/镇痛药的例子包括阿司匹林、阿司匹林铝、醋氯芬酸、阿西美辛、对乙酰氨基酚、阿氯芬酸、阿明洛芬、安吡昔康、安芬酸钠、异丙安替比林、布洛芬、吲哚美辛、吲哚美辛法奈、乙水杨胺、依托度酸、依匹唑、依莫法宗、盐酸替诺立定、盐酸噻拉米特、噁丙嗪、酮保泰松、酮洛芬、水杨酰水杨酸、水杨酰胺、水杨酸、水杨酸胆碱、水杨酸钠、扎托洛芬、双氯芬酸钠、双氟尼柳、舒林酸、安乃近、塞来考昔、噻洛芬酸、替诺昔康、托美丁钠、萘丁美酮、萘普生、吡罗昔康、非那西丁、非诺洛芬钙、芬替酸、芬布芬、氟芬那酸、氟比洛芬、氟芬那酸铝、普拉洛芬、夫洛非宁、马来酸丙谷美辛、甲芬那酸、美洛昔康、莫苯唑酸、乳酰乙氧苯胺、洛索洛芬钠、罗非考昔、氯诺昔康、托芬那酸、托芬那酸钠、替拉考昔(tiracoxib)、CS-502和T-614等。所述解热/镇痛药的优选例子包括阿司匹林、阿司匹林铝、对乙酰氨基酚、异丙安替比林、布洛芬、乙水杨胺、水杨酰水杨酸、水杨酰胺、水杨酸钠和乳酰乙氧苯胺。这些解热/镇痛药既可单独使用也可结合其中两种或多种一起使用。
可根据合用的其他药物的类型和用量基于公知的制剂技术,确定本发明药物组合物中所述解热/镇痛药的用量。通常成人的剂量为10~5,000毫克/天,优选225~3,000毫克/天。
除了以上的必要的药用成分之外,还可在本发明的药物组合物中加入其他药用成分。例如,可根据需要加入选自由抗组胺药、镇咳药、兴奋剂、维生素、生药、抗酸剂或粘膜保护剂组成的组中的一种或多种药用成分。
所述抗组胺药的例子包括盐酸异西喷地、盐酸二苯拉林、盐酸苯海拉明、盐酸二苯特罗、盐酸曲普利啶、盐酸曲吡那敏、盐酸松齐拉敏、盐酸芬乙嗪、盐酸甲地嗪、水杨酸苯海拉明、二苯二磺酸卡比沙明、酒石酸阿利马嗪、鞣酸苯海拉明、茶氯酸二苯拉林、萘二磺酸美海屈林、异丙嗪亚甲基二水杨酸酯、马来酸卡比沙明、dl-马来酸氯苯那敏、d-马来酸氯苯那敏、磷酸二苯特罗、异丙嗪、美喹他嗪、盐酸赛庚啶、盐酸异丙海汀、富马酸氯马斯汀、盐酸依匹斯汀、盐酸奥罗他定、盐酸非索非那定、氯雷他定、苯磺酸贝他斯汀、咪唑斯汀和NIP-531等。这些抗组胺药既可单独使用也可结合其中两种或多种一起使用。可根据合用的其他药物的类型和用量基于公知的制剂技术,确定所述抗组胺药的用量。通常成人的剂量为约1~300毫克/天,优选约1.5~150毫克/天。
所述镇咳药的例子包括盐酸阿洛拉胺、盐酸氯哌斯汀、枸橼酸替培啶、地布酸钠、氢溴酸右美沙芬、右美沙芬酚酞啉盐、海苯酸替培啶、芬地酸氯哌斯汀、磷酸可待因、磷酸双氢可待因、枸橼酸喷托维林、盐酸诺斯卡品、诺斯卡品、dl-盐酸甲麻黄碱、dl-甲麻黄碱糖精盐、枸橼酸喷托维林、磷酸二甲啡烷、磷酸苯丙哌林、枸橼酸异米尼尔、枸橼酸奥昔拉定、鞣酸奥昔拉定、盐酸依普拉酮、盐酸氯丁替诺、盐酸氯苯达诺、盐酸福米诺苯、l-盐酸甲麻黄碱、盐酸曲托喹酚、盐酸苯丙醇胺、盐酸甲氧那明、盐酸氯哌斯汀、羟蒂巴酚、阿片、盐酸乙基吗啡、盐酸吗啡、硫酸吗啡、盐酸阿片生物碱、TRK-851和CS-003。这些镇咳药既可单独使用也可结合其中两种或多种一起使用。可根据合用的其他药物的类型和用量基于公知的制剂技术,确定所述镇咳药的用量。通常成人的剂量为约2~900毫克/天,优选约12~90毫克/天。
所述兴奋剂的例子包括dl-盐酸甲麻黄碱、dl-甲麻黄碱糖精盐、安钠咖、咖啡因、无水咖啡因、盐酸麻黄碱、盐酸苯丙醇胺、去氧肾上腺素、l-盐酸甲麻黄碱、盐酸甲氧那明、dl-盐酸肾上腺素、dl-盐酸异丙肾上腺素、硫酸异丙肾上腺素、硫酸奥西那林、硫酸特布他林、硫酸沙丁胺醇、盐酸曲托喹酚、硫酸海索那林、盐酸氯丙那林、盐酸托布特罗、盐酸丙卡特罗、盐酸吡布特罗、氢溴酸非诺特罗、富马酸福莫特罗、盐酸克仑特罗、盐酸马布特罗、盐酸半胱乙酯、盐酸美司坦和伪麻黄碱等。这些兴奋剂既可单独使用也可结合其中两种或多种一起使用。可根据合用的其他药物的类型和用量基于公知的制剂技术,确定所述兴奋剂的用量。通常成人的剂量为约1~900毫克/天,优选约5~600毫克/天。
所述维生素的例子包括维生素B1、其衍生物及它们的盐类,如奥托硫胺、丙舒硫胺、呋喃硫胺、盐酸呋喃硫胺、双苯酰硫胺、苯磷硫胺、盐酸乙氧碳硫胺、赛可硫胺、辅羧酶、二硫硫胺、盐酸硫胺、硝酸硫胺、硝酸二硫胺、硫酸二鲸蜡硫胺(thiamine dicetylsulfate)、双异丁硫胺等;维生素B2、其衍生物及它们的盐类,如核黄素、丁酸核黄素、核黄素磷酸钠、黄素腺嘌呤二核苷酸钠等;维生素C、其衍生物及它们的盐类,如抗坏血酸、抗坏血酸钠、抗坏血酸钙等;橙皮苷、其衍生物及它们的盐类;维生素F;维生素A、其衍生物及它们的盐类,如乙酸维生素A和棕榈酸维生素A;维生素E、其衍生物及它们的盐类,如琥珀酸维生素E、琥钙维生素E、乙酸维生素E、维生素E。这些维生素既可单独使用也可结合其中两种或多种一起使用。可根据合用的其他药物的类型和用量基于公知的制剂技术,确定所述维生素的用量。通常成人的剂量为约0.1~2,000毫克/天,优选约1~500毫克/天。
所述生药的例子包括多种生药粉末及其浸膏,所述的生药举例来说有麻黄、南天竹、樱皮、远志、甘草、桔梗、车前子、车前草、石蒜、美远志、贝母、茴香、黄柏、黄连、莪术、春黄菊、桂皮、龙胆、牛黄、兽胆、沙参、生姜、苍术、丁香、陈皮、白术、地龙、竹节参(panax rhizome)、人参、黄芩、葛根、杏仁、香附子、粳米、厚朴、五味子、柴胡、细辛(asiasarumroot)、芍药、紫苏、枣、麦冬、半夏、茯苓、葛根汤、桂枝汤、香苏散、柴胡桂枝汤、小柴胡汤、小青龙汤、麦冬汤、半夏厚朴汤、麻黄汤、荆芥、连翘、辛夷、桃仁、附子。这些生药既可单独使用也可结合其中两种或多种一起使用。可根据合用的其他药物的类型和用量基于公知的制剂技术,确定所述生药的用量。通常成人的剂量为0.01~300克/天(浸膏的原生药换算量)或约0.0001~60克/天(粉末的原生药换算量),优选为0.05~30克/天(浸膏的原生药换算量)或约0.002-6克/天(粉末的原生药换算量)。
所述的抗酸剂或粘膜保护剂包括氨基乙酸、氧化镁、碳酸镁、硅酸镁、合成硅酸铝、合成水滑石、氨基乙酸二羟化铝、氢氧化铝凝胶、氢氧化铝干凝胶、氢氧化铝-碳酸镁混合干凝胶、氢氧化铝-碳酸氢钠共沉淀物、氢氧化铝-碳酸钙-碳酸镁共沉淀物、氢氧化镁-硫酸铝钾共沉淀物、硅铝酸镁、氢氧化镁、硫酸镁和硫糖铝等。这些药剂既可单独使用也可结合其中两种或多种一起使用。可根据合用的其他药物的类型和用量基于公知的制剂技术,确定所述抗酸剂或粘膜保护剂的用量。通常成人的剂量为约10~8,000毫克/天,优选约100~4,000毫克/天。
还可向所述的药物组合物中加入抗炎酶或除弗多司坦之外的其他祛痰药。所述抗炎酶的例子包括菠萝蛋白酶、链霉蛋白酶、舍雷肽酶、半碱性蛋白酶、链激酶、链道酶和氯化溶菌酶。这些药剂既可单独使用也可结合其中两种或多种一起使用。通常成人的剂量为4~300毫克/天,优选为15~60毫克/天。
所述的除弗多司坦之外的其他祛痰药的例子包括愈创木酚磺酸钾、愈创木酚甘油醚、碘化钾、茴香氨醑、碳酸氢钠、盐酸溴己新、羧甲半胱氨酸、盐酸氨溴素、盐酸美司坦、乙酰半胱氨酸、半胱氨酸乙酯盐酸盐、盐酸依普拉酮、氨茶碱、茶碱、二羟丙茶碱、丙羟茶碱、氯化铵、甲酚磺酸钾、l-薄荷醇、盐酸曲托喹酚、盐酸苯丙醇胺和盐酸甲氧那明等。这些祛痰药既可单独使用也可结合其中两种或多种一起使用。确定所述祛痰药的用量时,应考虑弗多司坦的用量。通常成人的剂量为1~3,000毫克/天,优选为6~900毫克/天。
本发明的药物组合物的制备是通过适当地组合上述成分与可药用的添加剂,并按常规方法将其制成口服用的固体、半固体或液体制剂例如片剂、颗粒剂、微粒剂、散剂、胶囊剂、软胶囊剂、丸剂、混悬剂、乳剂、内服的液体制剂、糖浆剂或干糖浆剂等。也可在制备上述制剂之前,先将所述的药用成分制成微粒,例如微囊、毫微囊、微球或毫微球等。
对制备本发明的药物组合物的方法没有特别的限制,可采用各种方法。例如,当需要制备用于片剂、颗粒剂、微粒剂、散剂、胶囊剂、丸剂或干糖浆剂等制剂的粒状粉末时,可采用常规的造粒方法,所述的造粒方法的例子包括使用含水或有机溶剂的溶液或分散液的湿式造粒法,例如喷雾造粒法、搅拌造粒法、流动床造粒法、旋转造粒法或旋转流动床造粒法等,以及使用粉状粘合剂的干式造粒法,如压缩造粒法。
可将含所述药用成分的粉末或粒状粉末混合并装入各种小包装,以制备颗粒剂、微粒剂或散剂等制剂。可使用胶囊填充机(capsuling machine)将散剂、粒状粉末或小片剂等填充到胶囊中制备胶囊制剂。可将药用成分的粉末、散剂、微粒剂、颗粒剂或丸剂与添加剂混合,并将所得的混合物压缩成型,从而制得片剂。
采用锅包衣法、流动床包衣法、旋转包衣法或其组合形式,用包衣材料包覆片剂或颗粒剂等制剂,从而制得例如糖衣片剂、薄膜包衣片剂或包衣颗粒剂等包衣制剂。可通过将所述包衣材料溶解和/或分散在水或有机溶剂中进行喷雾包衣;或采用加热或加压等制备条件直接喷洒包衣材料进行干式包衣。可根据剂型等条件,适当地选择所述包衣材料的用量。通常,所述的用量对于片剂来说是约0.1~100重量%,对于丸剂或颗粒剂来说是约0.1~200重量%,对于微粒剂来说是约0.1~300重量%。
通常,例如糖浆剂、酏剂、柠檬水、浸膏或饮剂等内服的液体制剂,以及填充了液体或半固体物质的硬胶囊或软胶囊等制剂也可采用以下方法制造:将药用成分与部分添加剂混合、或溶解或分散在部分添加剂中,该添加剂为例如纯净水等溶剂,然后向所得的混合物中添加剩余的添加剂例如溶剂等以调节液体的量。可采用酸或碱适当地调节pH值。可使用例如表面活性剂、增溶剂、乳化剂或助悬剂等添加剂使含脂溶性成分的制剂溶解、乳化或悬浊。如果有必要,在进行所述调节时,可对所得的混合物实施加热、冷却、氮气保护、过滤或杀菌等处理。
本发明的药物组合物中可适当地采用添加剂增加药用成分的稳定性、缓释性、持久性、快速崩解能力、快速溶解能力、改善的溶解性、味道掩盖性和改善的服用口感等性能。可采用常规方法来提供这些性能。所述的方法的例子包括各种方法,例如将药用成分添加到各自的颗粒中的方法、将药用成分制成多层颗粒的方法、将其制成多层片剂或有核片剂的方法、分别制粒再制成片剂的方法、将药用成分制成微囊的方法、制成例如糖衣片剂、薄膜包衣片剂或包衣颗粒剂等包衣制剂的方法、制成泡腾制剂的方法、制成咀嚼制剂的方法、制成口腔崩解剂的方法、制成骨架片制剂的方法、将药用成分一起粉碎的方法、制成固体溶液的方法、加入甜味剂或清凉剂的方法、加入抗氧化剂或稳定剂的方法以及使其具有特定的pH值、粘度、渗透压或盐浓度的方法。这些方法可组合使用。
可用作本发明的药物组合物中的可药用添加剂的例子有稳定剂、表面活性剂、增塑剂、滑润剂、增溶剂、还原剂、缓冲剂、甜味剂、基剂、吸附剂、矫味剂、粘合剂、助悬剂、抗氧化剂、增光剂、包衣剂、湿润剂、调湿剂、填充剂、消泡剂、清凉剂、着色剂、添味剂、香料、糖衣剂、等张剂、软化剂、乳化剂、增稠剂、泡腾剂、pH调节剂、稀释剂以及其他添加剂,例如赋形剂、分散剂、崩解剂、崩解助剂、崩解延缓剂、芳香剂、干燥剂、防腐剂、保存剂、溶解剂、溶解助剂、溶剂、助流剂、抗静电剂、增容剂、保湿剂和增湿剂。更具体地说,所述可药用添加剂的例子可以举出以下的添加剂。这些添加剂可单独使用,也可结合两种或多种一起使用。
所述赋形剂、基剂或填充剂的具体例子包括DL-丙氨酸、dl-苹果酸、D-山梨糖醇、D-山梨糖醇溶液、D-甘露醇、L-天冬氨酸、L-谷氨酰胺、β-环糊精、氨乙磺酸、粉状淀粉糖浆、阿拉伯胶、阿拉伯胶粉、海藻酸、海藻酸钠、海藻酸丙二酯、预凝胶淀粉、肌醇、乙醇、乙基纤维素、辛基癸基甘油三酯、米色欧巴代(opadry beige)、橄榄油、油酸、瓷土、可可脂、酪蛋白、酪蛋白酸钠、角叉菜胶、焦糖、巴西棕榈蜡、羧乙烯基聚合物、羧甲基淀粉钠、羧甲纤维素、羧甲纤维素钙、羧甲纤维素钠、甘草粉、琼脂、琼脂粉、黄原胶、木糖醇、枸橼酸、枸橼酸钠、枸橼酸二钠、甘氨酸、甘油、脂肪酸甘油酯、葡糖酸钙、葡糖酸钠、交联羧甲纤维素钠、交聚维酮、桂皮粉、硅铝酸镁、硅酸钙、硅酸镁、糙米麦芽、琥珀酸化明胶、芝麻油、小麦淀粉、小麦胚芽粉、米淀粉、胆固醇、红花油、白蜡、氨基乙酸二羟化铝、二甲基聚硅氧烷(内服用)、脂肪酸蔗糖酯、硬脂醇、硬脂酸、硬脂酸钙、聚乙二醇(40)硬脂酸酯、硬脂酸镁、玉米蛋白、脱水山梨糖醇倍半油酸酯、鲸蜡醇、石膏、明胶、脱水山梨醇脂肪酸酯、氢化豆油、豆油、滑石、葡聚糖40、糊精、脱氢乙酸钠、甘油磷酸钙、玉米糖浆、玉米淀粉、玉米淀粉粒、黄蓍胶、黄蓍胶粉、三醋精、菜籽油、珍珠粉、绿麦叶汁干燥粉末、蜂蜜、石蜡、马铃薯淀粉、可可浆、羟丙基淀粉、羟丙基纤维、羟丙基甲基纤维2208、羟丙基甲基纤维2906、羟丙基甲基纤维2910、羟丙基甲基纤维邻苯二甲酸酯、蓖麻油、葵花油、植酸、非那西丁、葡萄糖、葡糖水合物、支链淀粉、丙二醇、丙二醇脂肪酸酯、果胶、皂土、聚烯吡酮、聚丙烯酸钠、部分中和的聚丙烯酸、聚异丁烯、聚氧乙烯(105)聚氧丙烯(5)二醇、聚氧乙烯(160)聚氧丙烯(30)二醇、聚氧乙烯氢化蓖麻油、聚氧乙烯氢化蓖麻油(40)、聚氧乙烯氢化蓖麻油(60)、聚苯乙烯磺酸钠、聚山梨醇酯60、聚山梨醇酯80、聚乙烯醇缩乙醛二乙基氨基乙酸、(部分皂化的)聚乙烯醇、聚乙烯醇-二乙二醇混合物、牡蛎壳粉末、聚乙二醇1500、聚乙二醇1540、聚乙二醇20000、聚乙二醇300、聚乙二醇400、聚乙二醇4000、聚乙二醇6000、麦芽糖醇、黄蜡、肉豆寇醇、肉豆蔻酸辛基十二酯、甲基丙烯酸共聚物LD、硅铝酸镁、丙烯酸甲酯-甲基丙烯酸共聚物、甲基纤维素、木蜡、单硬脂酸铝、单硬脂酸甘油、十二烷基硫酸钠、聚桂醇、花生油、磷酸一氢钙、磷酸氢钙、磷酸氢钙颗粒、磷酸氢钠、磷酸二氢钾、磷酸二氢钙、磷酸二氢钠、玫瑰油、松香、氯化钠、果糖、干小球藻、干酵母、氢氧化铝干凝胶、干硫酸镁、寒梅粉、氢化麦芽糖淀粉糖浆、含水二氧化硅、含水无定形氧化硅、轻质二氧化硅、轻质液体石蜡、鲸蜡、结晶纤维素、结晶纤维素(颗粒)、结晶纤维素(微粒)、结晶纤维素-羧甲纤维素钠、氢化油、合成硅酸铝、合成硅酸铝-羟丙基淀粉-结晶纤维素、合成水滑石、氧化钛、氧化镁、蛇油、酒石酸、酒石酸氢钾、重质二氧化硅、小麦粉、小麦胚芽油、消毒用乙醇、烧石膏、乙酸钙、乙酸邻苯二甲酸纤维素、淀粉糖浆、氢氧化铝镁、氢氧化铝-碳酸镁-碳酸钙共沉淀物、氢氧化铝-碳酸氢钠共沉淀物、氢氧化铝凝胶、氢氧化镁、氢化植物油、生理盐水、精制明胶、精制虫胶、精制蜂蜜、纯水、精制蔗糖、精制蔗糖球状颗粒、大豆卵磷脂、非皂化豆油、磷酸三钙、脱脂奶粉、单糖浆、碳酸铵、碳酸钙、碳酸镁、中链脂肪酸甘油三酯、沉降碳酸钙、低取代羧甲基淀粉钠、低取代羟丙基纤维素、天然硅酸铝、二氧化硅、乳酸、乳酸钙、乳糖、乳糖颗粒、浓甘油、白色虫胶、蔗糖、蔗糖-淀粉球状颗粒、半消化淀粉、微晶纤维素、部分预凝胶的淀粉、粉糖、纤维素粉、氢化麦芽糖粉淀粉糖浆、米粉、枸橼酸酐、水合二氧化硅、无水磷酸氢钙、无水磷酸氢钙颗粒、无水乳糖、无水硫酸钠、无菌纯水、棉籽油、棉籽油-豆油混合物、药用炭、液体石蜡、硫酸钙和绿茶粉等。
所述溶剂、增溶剂、溶解剂或溶解助剂的具体例子包括dl-樟脑、D甘露醇、D-山梨糖醇、D-山梨糖醇溶液、L-天冬氨酸、L-精氨酸、α-环糊精、β-环糊精、己二酸、茴香油、酯化玉米油、乙醇、橄榄油、油酸、油酸油烯酯、羧甲纤维素钠、枸橼酸、枸橼酸钠、甘氨酸、甘油、脂肪酸甘油酯、芝麻油、红花油、红花油脂肪酸、水杨酸钠、紫苏油、二丁基羟甲苯、脂肪酸蔗糖酯、硬脂醇、聚乙二醇(40)硬脂酸酯、脱水山梨糖醇倍半油酸酯、脱水山梨糖醇脂肪酸酯、豆油、脱氢乙酸钠、玉米油、三醋精、脱水山梨糖醇三油酸酯、辛糖、菜籽油、烟酰胺、薄荷油、羟丙基纤维素、羟丙基甲基纤维素2910、蓖麻油、苯丙氨酯、葡萄糖、丙二醇、丙二醇脂肪酸酯、聚烯吡酮、聚氧乙烯(105)聚氧丙烯(5)二醇、聚氧乙烯(160)聚氧丙烯(30)二醇、聚氧乙烯氢化蓖麻油、聚氧乙烯氢化蓖麻油40、聚氧乙烯氢化蓖麻油60、聚山梨醇酯20、聚山梨醇酯60、聚山梨醇酯80、(部分皂化的)聚乙烯醇、聚乙二醇1500、聚乙二醇200、聚乙二醇300、聚乙二醇400、聚乙二醇4000、聚乙二醇600、聚乙二醇6000、马来酸、肉豆蔻酸异丙酯、脱水山梨糖醇单油酸酯、脱水山梨糖醇单月桂酸酯、椰子油、十二烷基硫酸钠、聚桂醇、花生油、利多卡因、林格氏溶液、磷酸、磷酸氢钠、磷酸二氢钾、苯甲酸钠、苯甲酸苄酯、氯化钠、氯化镁、干碳酸钠、稀盐酸、鱼鳞箔、氢化油、氧化镁、酒石酸、小麦胚芽油、消毒用乙醇、水、乙酸、乙酸邻苯二甲酸纤维素、氢氧化钠、生理盐水、精制豆油、纯水、精制大豆卵磷脂、石油醚、大豆卵磷脂、碳酸钠、碳酸氢钠、中链脂肪酸甘油三酯、低取代羟丙基纤维素、乳酸、浓甘油、蔗糖、冰醋酸、无水乙醇、枸橼酸酐、马来酸酐、无水磷酸氢二钠、无菌纯水、棉籽油和液体石蜡等。
所述崩解剂、崩解助剂、分散剂、干燥剂或助流剂的具体例子包括D-山梨糖醇、D-甘露醇、己二酸、甲基丙烯酸氨基烷基酯共聚物RS、阿拉伯树胶、阿拉伯树胶粉、海藻酸、海藻酸钠、海藻酸丙二酯、预凝胶的淀粉、乙醇、乙基纤维素、橄榄油、油酸、羧乙烯基聚合物、羧甲基淀粉钠、羧甲纤维素、羧甲纤维素钙、羧甲纤维素钠、甘草粉、琼脂粉、瓜尔胶、枸橼酸、枸橼酸钙、枸橼酸钠、甘油、脂肪酸甘油酯、交联羧甲纤维素钠、交聚维酮、硅酸镁、小麦淀粉、米淀粉、磷酸胆碱、红花油、白蜡、磺琥辛酯钠、脂肪酸蔗糖酯、硬脂酸、硬脂酸钙、聚乙二醇(40)硬脂酸酯、硬脂酸镁、脱水山梨糖醇倍半油酸酯、明胶、脱水山梨糖醇脂肪酸酯、滑石、豆油、糊精、玉米淀粉、黄蓍胶粉、脱水山梨糖醇三油酸酯、蜂蜜、石蜡、马铃薯淀粉、羟乙基纤维素、羟乙基甲基纤维素、羟丙基淀粉、羟丙基纤维素、羟丙基甲基纤维素2910、羟丙基甲基纤维素2910混合物、蓖麻油、富马酸、富马酸一钠、丙二醇、丙二醇脂肪酸酯、皂土、聚烯吡酮、聚氧乙烯(105)聚氧丙烯(5)二醇、聚氧乙烯(160)聚氧丙烯(30)二醇、聚氧乙烯氢化蓖麻油、聚氧乙烯氢化蓖麻油60、聚氧乙烯氢化蓖麻油40、聚山梨醇酯20、聚山梨醇酯40、聚山梨醇酯60、聚山梨醇酯80、聚乙烯醇缩乙醛二乙基氨基乙酸、多磷酸钠、聚乙二醇1500、聚乙二醇300、聚乙二醇400、聚乙二醇4000、聚乙二醇6000、硅铝酸镁、偏磷酸钠、甲基纤维素、木蜡、脱水山梨糖醇单油酸酯、单硬脂酸铝、单硬脂酸甘油酯、脱水山梨糖醇单棕榈酸酯、脱水山梨糖醇单月桂酸酯、十二烷基硫酸钠、聚桂醇、磷酸氢钙、磷酸氢钙颗粒、磷酸二氢钙、氢氧化铝干凝胶、轻质氧化铝、轻质二氧化硅、结晶纤维素、结晶纤维素-羧甲纤维素钠、氢化油、含水二氧化硅、合成硅酸铝、氧化钛、脱氢乙酸钠、重质二氧化硅、醋酸乙烯酯树脂、乙酸邻苯二甲酸纤维素、氢氧化铝镁、氢氧化钠、精制虫胶、精制大豆卵磷脂、精制蔗糖、大豆卵磷脂、磷酸三钙、碳酸镁、碳酸氢钠、沉降碳酸钙、低取代羧甲基淀粉钠、低取代羟丙基纤维素、乳糖、浓甘油、白色虫胶、蔗糖、部分预凝胶的淀粉、无水乙醇、枸橼酸酐、无水枸橼酸钠、无水焦磷酸钠和液体石蜡等。
所述pH调节剂、等张剂或缓冲剂的具体例子包括dl-苹果酸、D-山梨糖醇、D-山梨糖醇溶液、D-甘露醇、D-酒石酸、L-天冬氨酸镁、L-精氨酸、L-谷氨酸、L-谷氨酸钠、己二酸、抗坏血酸、氨乙基磺酸、木糖醇、枸橼酸、枸橼酸钙、枸橼酸钠、枸橼酸二钠、甘氨酸、甘油、葡糖酸-δ-内酯、葡糖酸钙、琥珀酸、琥珀酸二钠六水合物、烟酰胺、葡萄糖、富马酸一钠、丙二醇、多磷酸钠、聚乙二醇4000、马来酸、偏磷酸钠、磷酸、磷酸氢二钾、磷酸三钠、磷酸氢钠、磷酸二氢钾、磷酸二氢钠、玫瑰油、苯甲酸、苯甲酸钠、氯化钾、氯化钙、氯化钠、氯化镁、盐酸、盐酸葡糖胺、果糖、干亚硫酸钠、干碳酸钠、稀盐酸、酒石酸、乙酸、氢氧化钠、氢氧化镁、生理盐水、碳酸钠、碳酸氢钠、乳酸、乳酸钙、乳糖、浓甘油、冰醋酸、枸橼酸酐、无水枸橼酸钠、无水焦磷酸钠、无水磷酸氢二钠、无水磷酸三钠、无水磷酸二氢钠和硫酸氢钠等。
所述表面活性剂、乳化剂或泡腾剂的具体例子包括D-山梨糖醇、乙醇、角叉菜胶、羧乙烯基聚合物、羧甲纤维素钠、瓜尔胶、甘油、脂肪酸甘油酯、胆固醇、白色蜂蜡、磺琥辛酯钠、脂肪酸蔗糖酯、硬脂醇、硬脂酸、聚乙二醇(40)硬脂酸酯、脱水山梨糖醇倍半油酸酯、鲸蜡醇、明胶、脱水山梨糖醇脂肪酸酯、滑石、脱水山梨糖醇三油酸酯、石蜡、马铃薯淀粉、羟丙基纤维素、丙二醇、丙二醇脂肪酸酯、果胶、聚氧乙烯(105)聚氧丙烯(5)二醇、聚氧乙烯(160)聚氧丙烯(30)二醇、聚氧乙烯氢化蓖麻油、聚氧乙烯氢化蓖麻油40、聚氧乙烯氢化蓖麻油60、聚氧乙烯(35)蓖麻油、聚山梨醇酯20、聚山梨醇酯40、聚山梨醇酯60、聚山梨醇酯80、聚乙二醇400、肉豆蔻酸辛基十二酯、甲基纤维素、脱水山梨糖醇单油酸酯、单硬脂酸甘油酯、脱水山梨糖醇单棕榈酸酯、脱水山梨糖醇单月桂酸酯、氧化月桂基二甲胺溶液、十二烷基硫酸钠、聚桂醇、干碳酸钠、酒石酸、氢氧化钠、精制大豆卵磷脂、大豆卵磷脂、碳酸钾、碳酸氢钠、中链脂肪酸甘油三酯、枸橼酸酐、棉籽油-豆油混合物和液体石蜡。
所述湿润剂、粘合剂、助悬剂、增稠剂、胶粘剂、增粘剂、软化剂或增塑剂的具体例子包括D-山梨糖醇、D-山梨糖醇溶液、D-甘露醇、RSSNo.1生胶、β-克菌丹、β-环糊精、丙烯酸-丙烯酸辛酯共聚物、丙烯酸-2-乙基己酯—乙烯基吡咯烷酮共聚物溶液、丙烯酸-2-乙基己酯—甲基丙烯酸-2-乙基己酯—甲基丙烯酸十二酯共聚物溶液、丙烯酸酯-醋酸乙烯酯共聚物、丙烯酸乙酯-甲基丙烯酸甲酯共聚物分散液、脂肪酸乙酰甘油酯、丙烯酸-丝素蛋白共聚物树脂、丙烯酸甲酯—丙烯酸-2-乙基己酯共聚物树脂乳液、丙烯酸树脂链烷醇胺溶液、硬脂酸镁、甲基丙烯酸氨烷基酯共聚物E、甲基丙烯酸氨烷基酯共聚物RS、氨乙基磺酸、支链淀粉、粉状淀粉糖浆、阿拉伯胶、阿拉伯胶粉、海藻酸钠、海藻酸丙二酯、预凝胶淀粉、酯树胶、乙醇、乙基纤维素、异抗坏血酸钠、黄柏皮、橄榄油、油酸钠、瓷土、可可脂、酪蛋白酸钠、角叉菜胶、焦糖、巴西棕榈蜡、羧乙烯基聚合物、羧基甲基乙基纤维素、羧甲基淀粉钠、羧甲纤维素、羧甲纤维素钙、羧甲纤维素钠、琼脂、琼脂粉、黄原胶、乙酸苄酯、瓜尔胶、枸橼酸钠、甘氨酸、甘油、脂肪酸甘油酯、葡糖酸-δ-内酯、硅酸镁、硅铝酸镁、柯巴树脂、共聚维酮、芝麻油、小麦淀粉、米淀粉、火棉胶、硫酸软骨素钠、白蜡、磺琥辛酯钠、顺聚异戊二烯胶、氨乙酸二羟化铝、二丁基羟甲苯、二甲基聚硅氧烷(内用)、二甲基聚硅氧烷-二氧化硅混合物、脂肪酸蔗糖酯、硬脂醇、硬脂酸、硬脂酸铝、硬脂酸钙、聚乙二醇硬脂酸酯、聚乙二醇(40)硬脂酸酯、苯乙烯-异戊二烯-苯乙烯嵌段共聚物、苯乙烯异戊二烯胶乳、脱水山梨糖醇倍半油酸酯、鲸蜡醇、明胶、虫胶、脱水山梨糖醇脂肪酸酯、溶剂石脑油、大豆氢化油、滑石、达马树脂、葡聚糖70、糊精、萜烯树脂、(可溶)淀粉、玉米淀粉、玉米油、黄蓍胶、黄蓍胶粉、脱水山梨糖醇三油酸酯、菜籽油、高分子量顺聚异戊二烯胶(分子量:47,000)、蜂蜜、石蜡、马铃薯淀粉、中性维格姆(veegum neutral)、羟乙基纤维素、羟乙基甲基纤维素、羟丙基淀粉、羟丙基纤维素、羟丙基甲基纤维素2208、羟丙基甲基纤维素2906、羟丙基甲基纤维素2910、乙酸琥珀酸羟丙基甲基纤维素、羟丙基甲基纤维素邻苯二甲酸酯、乙烯基吡咯烷酮-乙酸乙烯酯共聚物、胡椒基丁醚、蓖麻油、葡萄糖、富马酸、富马酸-硬脂酸-聚乙烯醇缩乙醛二甲基氨基乙酸酯-羟丙基甲基纤维素2910混合物、硬脂基富马酸钠、支链淀粉、丙二醇、丙二醇脂肪酸酯、果胶、皂土、聚烯吡酮、聚丙烯酸、聚丙烯酸钠、聚丙烯酸水溶液、部分中和的聚丙烯酸、聚异丁烯、聚氧乙烯(160)聚氧丙烯(30)二醇、聚氧乙烯氢化蓖麻油、聚氧乙烯氢化蓖麻油60、聚山梨醇酯20、聚山梨醇酯60、聚山梨醇酯80、聚山梨醇酯80-聚乙烯醇缩乙醛二乙基氨乙酸酯、(完全皂化的)聚乙烯醇、(部分皂化的)聚乙烯醇、聚丁烯、多磷酸钠、聚乙二醇1500、聚乙二醇20000、聚乙二醇300、聚乙二醇400、聚乙二醇4000、聚乙二醇600、聚乙二醇6000、马来松香甘油酯、黄蜡、甲基丙烯酸-丙烯酸正丁酯共聚物、甲基丙烯酸共聚物L、甲基丙烯酸共聚物LD、甲基丙烯酸共聚物S、硅铝酸镁、偏磷酸钠、甲基纤维素、甲基乙烯基醚-马来酸酐共聚物、木蜡、单硬脂酸甘油酯、十二烷基硫酸钠、聚桂醇、花生油、磷酸、磷酸氢钙、松香、氯化钙、氯化钠、氯化镁、含水羊毛脂、水解明胶粉、水解淀粉的轻质二氧化硅、果糖、氢氧化铝干凝胶、寒梅粉、还原淀粉糖浆、含水二氧化硅、含水无定形氧化硅、轻质二氧化硅、含轻质二氧化硅的羟丙基纤维素、轻质液体石蜡、结晶纤维素、结晶纤维素-羧甲纤维素钠、氢化油、高分子量聚乙烯吡咯烷酮、合成硅酸铝、合成蜡、氧化钛、氧化镁、饱和脂环烃树脂、脂肪烃树脂、酒石酸钠钾、重质二氧化硅、小麦粉、水、醋酸乙烯酯树脂、乙酸邻苯二甲酸纤维素、淀粉糖浆、氢氧化铝凝胶、氢氧化钾、氢氧化钠、氢化松香甘油酯、生胶、精制明胶、精制虫胶、纯水、精制蔗糖、石油醚、石油树脂、大豆卵磷脂、单糖浆、碳酸钙、碳酸镁、中链脂肪酸甘油三酯、沉降碳酸钙、低取代羟丙基纤维素、乳酸、乳糖、浓甘油、白色虫胶、白凡士林、蔗糖、微晶纤维素、部分预凝胶的淀粉、米粉、无水乙醇、棉籽油-豆油混合物、液体石蜡、硫酸钙和磺化蓖麻油钾盐-烷基苯磺酸混合物等。
所述包衣剂、糖衣剂、增光剂或消泡剂的具体例子包括丙烯酸2-甲基-5-乙烯基吡啶甲酯—甲基丙烯酸共聚物、dl-苹果酸、D-山梨糖醇、D-山梨糖醇溶液、D-甘露醇、丙烯酸乙酯-甲基丙烯酸甲酯共聚物分散液、脂肪酸乙酰甘油酯、甲基丙烯酸氨基烷酯共聚物E、甲基丙烯酸氨基烷酯共聚物RS、阿拉伯胶、阿拉伯胶粉、精制虫蜡、乙醇、乙基纤维素、乙基纤维素水分散液、辛癸基甘油三酯、Opadry OY-6950、OpadryOY-S-22829、Opadry OY-S-22835、Opadry OY-S-22961、OpadryOY-S-7135、Opadry OY-S-8471、Opadry OY-S-9607、橄榄油、瓷土、可可脂、夏枯草、氢化蓖麻油、焦糖、巴西棕榈蜡、羧乙烯基聚合物、羧甲基乙基纤维素、羧甲基淀粉钠、羧甲纤维素钙、羧甲纤维素钠、枸橼酸三乙酯、甘油、脂肪酸甘油酯、硅酸镁、琥珀酸化明胶、小麦淀粉、米淀粉、白色蜂蜡、丙烯酸二甲基氨基乙酯-甲基丙烯酸甲酯共聚物、二甲基聚硅氧烷(内服)、二甲基聚硅氧烷-二氧化硅混合物、脂肪酸蔗糖酯、有机硅树脂乳液、有机硅消泡剂、沉香粉、硬脂醇、硬脂酸、硬脂酸铝、硬脂酸钙、聚乙二醇(40)硬脂酸酯、硬脂酸镁、玉米蛋白、脱水山梨糖醇倍半油酸酯、鲸蜡醇、石膏、虫胶、脱水山梨糖醇脂肪酸酯、滑石、萜烯树脂、(可溶)淀粉、玉米淀粉、玉米油、三醋精、失水山梨糖醇三油酸酯、珍珠粉、蜂蜜、石蜡、马铃薯淀粉、羟丙基纤维素、羟丙基甲基纤维素2208、羟丙基甲基纤维素2906、羟丙基甲基纤维素2910、羟丙基甲基纤维素2910-氧化钛-聚乙二醇400混合物、乙酸琥珀酸羟丙基甲基纤维素、羟丙基纤维素邻苯二甲酸酯、胡椒基丁醚、蓖麻油、苯二甲酸二乙酯、丁基邻苯二甲酰基甘醇酸丁酯、葡萄糖、富马酸-硬脂酸-聚乙烯醇缩乙醛二乙基氨基乙酸酯-羟丙基甲基纤维素2910混合物、支链淀粉、丙二醇、皂土、聚烯吡酮、聚氧乙烯(105)聚氧丙烯(5)二醇、聚氧乙烯(160)聚氧丙烯(30)二醇、聚氧乙烯氢化蓖麻油40、聚氧乙烯氢化蓖麻油60、聚山梨醇酯80、聚乙烯醇缩乙醛二乙基氨基乙酸酯、(部分皂化的)聚乙烯醇、聚乙二醇1500、聚乙二醇1540、聚乙二醇20000、聚乙二醇300、聚乙二醇35000、聚乙二醇400、聚乙二醇4000、聚乙二醇600、聚乙二醇6000、黄蜡、肉豆寇醇、甲基丙烯酸共聚物L、甲基丙烯酸共聚物LD、甲基丙烯酸共聚物S、硅铝酸镁、甲基纤维素、木蜡、单硬脂酸铝、单硬脂酸甘油酯、脱水山梨糖醇单月桂酸酯、褐煤酸酯蜡、十二烷基硫酸钠、聚桂醇、磷酸一氢钙、磷酸氢钙、磷酸氢钠、磷酸二氢钙、松香、干甲基丙烯酸共聚物LD、氢氧化铝干凝胶、干漂白虫胶片、寒梅粉、含水二氧化硅、鱼鳞箔、金箔、银箔、轻质二氧化硅、轻质液体石蜡、含轻质二氧化硅的羟丙基纤维素、鲸蜡、结晶纤维素、氢化蜡、氢化油、高葡萄糖淀粉糖浆、合成硅酸铝、合成蜡、氧化钛、氧化镁、小麦粉、烧石膏、乙酸纤维素、醋酸乙烯酯树脂、乙酸邻苯二甲酸纤维素、淀粉糖浆、氢氧化铝凝胶、氢化松香甘油酯、精制明胶、精制虫胶、精制石蜡-巴西棕榈蜡混合蜡、精制蔗糖、磷酸三钙、单糖浆、碳酸钙、碳酸镁、脱色银箔、沉降碳酸钙、低取代羟丙基纤维素、乳酸钙、乳糖、浓甘油、白色虫胶、蔗糖、部分预凝胶的淀粉、粉糖、水合二氧化硅、邻苯二甲酸酐、无水磷酸氢钙、药用炭、液体石蜡和硫酸钙等。
所述稳定剂、抗氧化剂、保存剂或防腐剂的具体例子包括己二酸、DL-丙氨酸、dl-樟脑、D-山梨糖醇溶液、d-龙脑、D-山梨糖醇、D-甘露醇、L-抗坏血酸硬脂酸酯、L-抗坏血酸钠、L-天冬氨酸、L-天冬氨酸钠、L-精氨酸、l-薄荷醇、β-环糊精、抗坏血酸、氨基乙磺酸、海藻酸钠、海藻酸丙二醇酯、白蛋白、硫、肌醇、茴香粉、乙醇、依地酸钙二钠、依地酸钠、异抗坏血酸、异抗坏血酸钠、可可脂、羧乙烯基聚合物、羧甲纤维素钙、羧甲纤维素钠、琼脂、黄原胶、木糖醇、枸橼酸、枸橼酸钙、枸橼酸钠、甘氨酸、甘油、脂肪酸甘油酯、葡糖酸-δ-内酯、葡糖酸钙、桂皮粉、芝麻油、硫酸软骨素钠、水杨酸、水杨酸钠、水杨酸苯酯、二丁基羟甲苯、脂肪酸蔗糖酯、硬脂酸、硬脂酸铝、聚乙二醇硬脂酸酯、硬脂酸镁、脱水山梨糖醇倍半油酸酯、鲸蜡醇、明胶、脱水山梨糖醇脂肪酸酯、山梨酸、山梨酸钾、滑石、葡聚糖、葡聚糖40、葡聚糖70、脱氢乙酸、脱氢乙酸钠、甘草酸二钠、生育酚、薄荷醇、萘酚、烟酰胺、蜂蜜、对羟基苯甲酸异丁酯、对羟基苯甲酸异丙酯、对羟基苯甲酸乙酯、对羟基苯甲酸丁酯、对羟基苯甲酸丙酯、对羟基苯甲酸甲酯、泛酸钙、羟丙基纤维素、氢醌、焦磷酸四钠、焦亚硫酸钠、非那西丁、叔丁基对羟基茴香醚、葡萄糖、富马酸、富马酸一钠、聚烯吡酮、部分中和的聚丙烯酸、聚氧乙烯(160)聚氧丙烯(30)二醇、聚氧乙烯氢化蓖麻油60、聚山梨酸酯20、聚山梨酸酯60、聚山梨酸酯80、(部分皂化的)聚乙烯醇、多磷酸钾、多磷酸钠、聚乙二醇300、聚乙二醇400、聚乙二醇4000、马来酸、丙二酸、硅铝酸镁、偏磷酸钠、甲基纤维素、甲基橙皮苷、单硬脂酸铝、单硬脂酸甘油酯、桉树油、十二烷基硫酸钠、龙脑粉、苹果酸、磷酸、磷酸氢二钠、磷酸二氢钾、磷酸二氢钙、亚硫酸钠、亚硫酸氢钠、苯甲酸、苯甲酸钠、苯甲酸苄酯、氯化钙、氯化钠、氯化镁、盐酸、盐酸精氨酸、盐酸半胱氨酸、果糖、干亚硫酸钠、干碳酸钠、含水二氧化硅、稀盐酸、轻质二氧化硅、结晶纤维素、氢化油、氧化镁、酒石酸、乙酸、乙酸生育酚、氢氧化钠、氢氧化镁、精制明胶、精制大豆卵磷脂、精制蔗糖、氢氧化铝干凝胶、大豆卵磷脂、非皂化豆油、碳酸钾、碳酸钠、碳酸镁、碳酸氢钾、碳酸氢钠、氮气、天然维生素E、乳酸、乳糖、浓甘油、蔗糖、微晶纤维素、冰醋酸、没食子酸丙酯、枸橼酸酐、无水枸橼酸钠、无水焦磷酸钠、无水磷酸氢二钠、药用炭和卵清蛋白等。
所述矫味剂、清凉剂、芳香剂或甜味剂的具体例子包括5’-肌苷酸二钠、5-鸟苷酸二钠、DL-丙氨酸、dl-樟脑、dl-薄荷醇、dl-苹果酸、dl-苹果酸钠、DL-酒石酸钠、d-樟脑、D-木糖、D-山梨糖醇、D-山梨糖醇溶液、d-龙脑、D-甘露醇、D-酒石酸、L-天冬氨酸、L-天冬氨酸钠、L-天冬氨酸镁、L-谷氨酸、L-谷氨酸L-精氨酸、L-谷氨酸钠、L-谷氨酸盐酸盐、l-薄荷醇、β-环糊精、抗坏血酸、阿斯巴甜、棕儿茶粉、甘茶、甘茶浸膏、甘茶粉、氨基乙磺酸、茴香、茴香酊剂、茴香粉、茴香油、乙醇、乙基香草醛、赤藓醇、黄柏皮粉、樱皮浸膏、黄连、黄连粉、芒柄花根干浸膏、橙、桔油、可可粉、焦糖、卡巴胆碱、甘草、甘草浸膏、粗甘草浸膏、甘草粉、木糖醇、枸橼酸、枸橼酸钙、枸橼酸钠、甘氨酸、甘油、甘草酸、甘草酸二铵、甘草酸二钾、甘草酸二钠、甘草酸一铵、甘草酸三钠、葡糖酸-δ-内酯、小球藻浸膏、小球藻粉、桂皮酊剂、桂皮粉、桂皮油、琥珀酸、琥珀酸二钠六水合物、琥珀酸一钠、昆布粉、糖精、糖精钠、藏红花粉末、苦椒皮酊剂、苦椒皮粉、豆蔻籽粉、生姜酊剂、生姜粉、生姜油、沉香粉、肉桂醛、硬脂酸、留兰香油、当药、紫苏粉、豆油、枣粉、泽泻根/草干浸膏、鞣酸、丁香酊剂、丁香油、陈皮酊剂、辣椒、辣椒粉、辣椒酊剂、苦橙皮酊剂、苦橙皮粉、苦木粉、菠萝粉香料51357、菠萝粉香料59492、蜂蜜、薄荷水、薄荷油、香草粉香料5428632、焦磷酸四钠、葡萄酒、葡萄糖、葡萄糖-果糖糖浆、富马酸、富马酸一钠、薄荷粉、聚吡维酮、麦芽糖醇、麦芽糖醇溶液、麦芽浸膏、麦芽糖、千叶芪草干浸膏、甲基纤维素、薄荷醇粉、桉树油、龙脑、龙脑粉、林格氏溶液、苹果汁、苹果醋、浓苹果汁(500%)、柠檬油、玫瑰水、玫瑰油、蜂王浆、糖浆、氯化钠、氯化镁、盐酸、果糖、果糖-葡萄糖糖浆、干酵母、还原麦芽糖淀粉糖浆、稀盐酸、高葡萄糖淀粉糖浆、高果糖糖浆、红糖、酒石酸、酒石酸氢钾、食用胡萝卜粉、乙酸、淀粉糖浆、精制甘草浸膏粉末、精制蜂蜜、精制蔗糖、精制蔗糖球状颗粒、脱脂奶粉、单糖浆、碳酸氢钠、中链脂肪酸甘油三酯、铜叶绿酸钠、乳酸、乳糖、浓甘油、李子浸膏、冰醋酸、粉糖、还原麦芽糖粉淀粉糖浆、无水乙醇、枸橼酸酐、无水焦磷酸钠、乳酸乙酯和绿茶粉等。
所述的吸附剂的具体例子包括瓷土、羧甲纤维素钙、含水二氧化硅、硅酸镁、轻质二氧化硅、硅藻土、结晶纤维素、合成硅酸铝、氧化铝、氢氧化铝、碳酸镁、沉降碳酸钙、糊精、二氧化硅、皂土、硅铝酸镁和药用炭等。
所述消泡剂的具体例子包括乙醇、脂肪酸甘油酯、二甲基聚硅氧烷(内服)、二甲基聚硅氧烷-二氧化硅混合物、脂肪酸蔗糖酯、有机硅树脂乳液、有机硅消泡剂、聚乙二醇(40)硬脂酸酯、脱水山梨糖醇脂肪酸酯、脱水山梨糖醇三油酸酯和聚山梨醇酯80等。
所述咀嚼剂的具体例子包括d-龙脑等。
所述着色剂的具体例子包括棕儿茶鞣酸粉末、姜黄浸膏溶液、黄三氧化二铁、Opaspray K-1-24904、柑橙香精、棕色氧化铁、炭黑、焦糖、卡红、胡萝卜素溶液、β-胡萝卜素、甘草浸膏、金箔、黑色氧化铁、轻质二氧化硅、氧化钛、三氧化二铁、食用蓝色1号、食用黄色4号、食用黄色4号铝土、食用黄色5号、食用红色2号、食用红色3号、食用红色102号、氢氧化钠、滑石、铜叶绿酸钠、叶绿酸铜、绿大麦叶浸膏、d-龙脑、月桂酸辛基十二酯、药用炭、丁酸核黄素、核黄素、绿茶粉、核黄素磷酸钠和玫瑰油等。
所述减痛剂的具体例子包括肌醇、碳酸氢钠、丁香油、葡萄糖、丙二醇和利多卡因等。
因为上述本发明的药物组合物中含有的弗多司坦和解热/镇痛药可产生相互作用从而增强所述两种成分的疗效,所以本发明的药物组合物可有效地用作治疗或缓解感冒等病症的药物,特别是伴有多痰的感冒等病症的药物。
具体而言,如下述试验例所示,通过组合使用弗多司坦和解热/镇痛药,增强了所述弗多司坦的祛痰效果和所述解热/镇痛药的抗炎效果。因此,可期望得到改善的疗效。
实施例
以下将参照实施例和试验例对本发明进行更详细的描述,但不应将这些实施例和试验例用于限制本发明的范围。
试验例1
用于确证祛痰的协同效果的试验
通过下述方法,确证合用弗多司坦和解热/镇痛药改善了祛痰效果。其结果列于表1。
(方法)
以每组七只12周龄的雄性费歇尔(Fischer)(F334)大鼠作为试验动物。使用戊巴比妥将这些大鼠麻醉,并使用手术用的去甲羟基安定(isodine)溶液对其皮肤进行消毒。正中切开,露出所述大鼠的气管。将连接着汉密尔顿注射器的注射针从咽部插入,从而将脂多糖(LPS,10μg/500μl)注射到气管内。将成分和剂量如表1所示的样品溶解或悬浮在0.5%CMC-Na溶液中。所述大鼠口服给予所得溶液或悬浮液共计三次,具体地说,是分别在给予LPS前30分钟、给予LPS后24小时和给予LPS后48小时后服用。给予LPS三天后,在所述大鼠处于戊巴比妥麻醉的状态下,切断其腹主动脉,使所述大鼠失血致死。取出其部分气管和支气管,并将所得气管和支气管固定于10%中性缓冲福尔马林溶液中。根据常规方法,将固定的支气管埋入石蜡中。将所述气管沿横截面切成片。使用阿尔新蓝/PAS(AB/PAS)将所得切片染色。显微镜观察每一气管的AB/PAS染色样品,根据已公开的方法(Enviromn.Tixicol.Pharmacol.,第5卷,第173页,1998年)测定杯形细胞的数目。
(结果)
表1
试验组 | 杯形细胞的数目 |
弗多司坦30mg/kg布洛芬50mg/kg布洛芬100mg/kg对乙酰氨基酚100mg/kg对乙酰氨基酚200mg/kg | 75.7±1.3**124.9±1.8124.3±2.0125.7±2.4122.9±1.7 |
弗多司坦(30mg/kg)+布洛芬(50mg/kg)弗多司坦(30mg/kg)+布洛芬(100mg/kg)弗多司坦(30mg/kg)+对乙酰氨基酚(100mg/kg)弗多司坦(30mg/kg)+对乙酰氨基酚(200mg/kg) | 52.9±2.3a),$$,**45.9±1.5b),$$,**,α47.9±0.7c),$$,**43.6±0.9d),$$,**,β |
未处理组 | 23.3±0.9 |
对照组 | 122.9±2.0$$ |
**:p<0.01,对于对照组
##:p<0.01,对于未处理组
a):p<0.01,对于布洛芬50mg/kg组
b):p<0.01,对于布洛芬100mg/kg组
c):p<0.01,对于对乙酰氨基酚100mg/kg组
d):p<0.01,对于对乙酰氨基酚200mg/kg组
$$:p<0.01,对于弗多司坦(30mg/kg)组
α:p<0.01,对于弗多司坦(30mg/kg)+布洛芬(50mg/kg)组
β:p<0.01,对于弗多司坦(30mg/kg)+对乙酰氨基酚(100mg/kg)组
以上结果显示,单独服用弗多司坦可使杯形细胞的数目发生下降,表现出祛痰效果,相反,单独服用布洛芬或对乙酰氨基酚并没有改变杯形细胞的数目,因而没有祛痰效果。然而,与单独服用弗多司坦所导致的杯形细胞数目的下降相比,合用弗多司坦与布洛芬或对乙酰氨基酚导致杯形细胞的数目发生了更为显著的下降。因此,通过合用弗多司坦与布洛芬或对乙酰氨基酚,增强了所述的祛痰效果。弗多司坦和布洛芬或对乙酰氨基酚均显示出剂量反应,并产生了协同效应。因此,显而易见的是,通过合用弗多司坦与解热/镇痛药,增强了祛痰效果。
试验例2
用于确证抗炎的协同效果的试验
通过下述方法,确证合用弗多司坦和解热/镇痛药改善了抗炎效果。其结果列于表2。
(方法)
采用每组五只5周龄的雄性Wistar大鼠作为试验动物。将成分和剂量如表2所示的样品溶解或悬浮在0.5%CMC-Na溶液中。连续五天每天一次,口服给予所述大鼠所得的溶液或悬浮液。在服用期的最后一日,待其服用完两小时后,将0.1ml的发炎剂(角叉菜胶)通过皮下注射的方式从所述大鼠的右后肢脚底注入。在注射完发炎剂四小时后,测定所述大鼠的足体积。基于注射发炎剂前的足体积,计算其水肿率。用防自舔罩将所述大鼠罩上后,使用器官充满度测量器(由Ugo Basile社制造)测定其右后肢体积。
(结果)
表2
测试组 | 水肿率(%) |
布洛芬50mg/kg布洛芬100mg/kg对乙酰氨基酚100mg/kg对乙酰氨基酚200mg/kg | 70.6±0.89**60.6±0.79**,a)70.6±0.68**60.6±0.88**,b) |
弗多司坦(30mg/kg)+布洛芬(50mg/kg)弗多司坦(30mg/kg)+布洛芬(100mg/kg)弗多司坦(30mg/kg)+对乙酰氨基酚(100mg/kg)弗多司坦(30mg/kg)+对乙酰氨基酚(200mg/kg) | 60.6±0.91**49.7±0.57**,c)60.5±0.88**49.5±0.71**,d) |
对照组(服用0.5%CMC-Na) | 81.4±0.71 |
**:p<0.01,对于对照组
a):p<0.01,对于布洛芬50mg/kg组
b):p<0.01,对于对乙酰氨基酚100mg/kg组
c):p<0.01,对于弗多司坦(30mg/kg)+布洛芬(50mg/kg)组
d):p<0.01,对于弗多司坦(30mg/kg)+对乙酰氨基酚(100mg/kg)组
以上结果显示,单独服用的布洛芬或对乙酰氨基酚具有剂量依赖性的抗炎效果。布洛芬或对乙酰氨基酚在与弗多司坦合用时,所表现出的抗炎效果优于单独服用布洛芬或对乙酰氨基酚时的效果。因此,显而易见的是,通过合用弗多司坦与解热/镇痛药,抗炎效果得到了增强。
实施例1
片剂:
采用常规方法将弗多司坦(200g)、布洛芬(75g)、玉米淀粉(33g)、滑石(1g)和硬脂酸镁(1g)制成压片用的粉末。使用旋转压片机对所得粉末进行压片,从而制得每片直径为9mm、重为310mg的片剂。
实施例2
片剂:
采用常规方法将弗多司坦(133.3g)、对乙酰氨基酚(100g)、马铃薯淀粉(44.7g)、滑石(1g)和硬脂酸镁(1g)制成压片用的粉末。使用旋转压片机对所得粉末进行压片,从而制得每片直径为8.5mm、重为280mg的片剂。
实施例3
液体制剂:
将弗多司坦(8g)、对乙酰氨基酚(6g)、赤藓醇(20g)、焦糖(100mg)、苯甲酸钠(70mg)和香料(100mg)溶于纯水。向所得的混合物中加入适当量的磷酸,以调节其pH值,接着再向该混合物中加入纯水,从而使其总量达到100ml,由此制得液体制剂。
实施例4
片剂:
采用常规方法将弗多司坦(80g)、布洛芬(45g)、磷酸二氢可待因(2.4g)、dl-盐酸甲麻黄碱(6g)、马来酸氯苯那敏(0.75g)、无水咖啡因(7.5g)、硝酸硫胺(2.4g)、抗坏血酸(30g)、玉米淀粉(49.75g)、乳糖(40g)、结晶纤维素(20g)、羟丙基纤维素(10g)、轻质二氧化硅(10g)、滑石(2g)和硬脂酸镁(1g)制成压片用的粉末。使用旋转压片机对所得粉末进行压片,从而制得每片直径为9mm、重为250mg的片剂。
实施例5
糖浆剂:
将弗多司坦(4g)、对乙酰氨基酚(3g)、磷酸二氢可待因(0.08g)、dl-盐酸甲麻黄碱(0.2g)、马来酸氯苯那敏(0.025g)、无水咖啡因(0.25g)、海藻糖(120g)、枸橼酸(0.1g)、枸橼酸钠(1g)、焦糖(0.1g)和香料(0.5g)溶于纯水,从而制得总量为240ml的糖浆剂。
实施例6
片剂:
采用常规方法将弗多司坦(160g)、对乙酰氨基酚(180g)、马来酸氯马斯汀(0.268g)、氯化溶菌酶制剂(13.2g)、磷酸二氢可待因(4.8g)、诺斯卡品(7.2g)、dl-盐酸甲麻黄碱(12g)、愈创木酚磺酸钾(48g)、无水咖啡因(15g)、苯磷硫胺(4.8g)、玉米淀粉(47.8g)、乳糖(209.32g)、结晶纤维素(40g)、羟丙基纤维素(6g)、轻质二氧化硅(4g)、滑石(6g)和硬脂酸镁(6g)制成压片用的粉末。使用旋转压片机对所得粉末进行压片,从而制得每片直径为9mm、重为320mg的片剂。
实施例7
颗粒剂:
采用常规方法将弗多司坦(200g)、对乙酰氨基酚(150g)、盐酸苯丙醇胺(12.5g)、马来酸氯苯那敏(1.3g)、氢溴酸右美沙芬(8g)、舍雷肽酶(2.5g)、无水咖啡因(12.5g)、盐酸呋喃硫胺(4.2g)、核黄素(2.0g)、玉米淀粉(333.3g)、轻质二氧化硅(10g)、精制蔗糖(203.8g)、羧甲纤维素(50g)和阿斯巴甜(10g)制成颗粒。将所得颗粒按每包2g的重量分别装入多个小包装,从而制得颗粒剂。
实施例8
薄膜包衣片剂:
采用常规方法将弗多司坦(400g)、对乙酰氨基酚(600g)、氯化溶菌酶制剂(44g)、磷酸二氢可待因(16g)、诺斯卡品(32g)、dl-盐酸甲麻黄碱(40g)、马来酸卡比沙明(5g)、愈创木酚甘油醚(83.34g)、无水咖啡因(50g)、双异丁硫胺(16g)、核黄素(8g)、玉米淀粉(40g)、乳糖(35.66g)、结晶纤维素(60g)、羟丙基纤维素(60g)、轻质二氧化硅(4g)、滑石(4g)和硬脂酸镁(2g)制成压片用的粉末。使用旋转压片机对所得粉末进行压片,从而制得每片直径为8.5mm、重为250mg的片剂。然后,将所得片剂投入包衣锅,使用以乙醇与纯水的1∶1混合物为溶剂并含有羟甲基纤维素(5重量%)、聚乙二醇6000(0.3重量%)和氧化钛(0.2重量%)的溶液作为包衣溶液,将所得片剂包覆,从而制得薄膜包衣片剂,每片增重15mg。
实施例9
胶囊制剂:
采用常规方法将弗多司坦(400g)、对乙酰氨基酚(300g)、盐酸溴己新(4g)、氯化溶菌酶制剂(22g)、磷酸二氢可待因(8g)、dl-盐酸甲麻黄碱(20g)、马来酸卡比沙明(2.5g)、无水咖啡因(25g)、双异丁硫胺(8g)、核黄素(4g)、玉米淀粉(96.5g)和羟丙基纤维素(10g)制成颗粒。将所得颗粒按每胶囊300mg的重量分别装入多个硬胶囊,从而制得胶囊制剂。
实施例10
胶囊制剂:
采用常规方法将弗多司坦(200g)、布洛芬(300g)、磷酸二氢可待因(12g)、马来酸卡比沙明(5g)、dl-盐酸甲麻黄碱(40g)、无水咖啡因(50g)、愈创木酚磺酸钾(160g)、硝酸硫胺(16g)、核黄素(8g)、玉米淀粉(197g)和羟丙基纤维素(12g)制成颗粒。将所得颗粒按每胶囊250mg的重量分别装入多个硬胶囊,从而制得胶囊制剂。
实施例11
糖衣片剂:
采用常规方法将弗多司坦(200g)、对乙酰氨基酚(240g)、d-马来酸氯苯那敏(2.3g)、乙水杨胺(600g)、氢溴酸右美沙芬(32g)、诺斯卡品(32g)、dl-盐酸甲麻黄碱(20g)、愈创木酚磺酸钾(166.7g)、甘草浸膏粉末(48g)樱皮浸膏(53.3g)、无水咖啡因(100g)、玉米淀粉(166.7g)、结晶纤维素(82.3g)、羟丙基纤维素(20g)、轻质二氧化硅(20g)、滑石(10g)和硬脂酸镁(6.7g)制成压片用的粉末。使用旋转压片机对所得粉末进行压片,从而制得每片直径为9mm、重为300mg的片剂。将所得片剂投入包衣锅。使用以乙醇与纯水的1∶1混合物为溶剂并含有羟甲基纤维素(5重量%)的溶液作为包衣溶液,将所得片剂包覆,其每片增重10mg。接着,采用包含滑石(2重量%)、氧化钛(2重量%)、碳酸钙(3重量%)、阿拉伯胶粉(1重量%)和精制蔗糖(60重量%)的溶液给所述包衣片剂加上内涂层,使其每片增重130mg。然后,采用含精制蔗糖(60重量%)的溶液,在具有内涂层的片剂上再涂一层包衣,使其每片增重10mg,从而制得糖衣片剂。
实施例12
散剂:
采用常规方法将弗多司坦(150g)、阿司匹林铝(50.625g)、对乙酰氨基酚(50.625g)、乙水杨胺(45g)、地龙浸膏粉末(18.75g)、盐酸二苯拉林(0.5g)、氢溴酸右美沙芬(6g)、愈创木酚磺酸钾(18.75g)、甘草浸膏(16.875g)、远志干浸膏(3.75g)、玉米淀粉(129.125g)、轻质二氧化硅(5g)、阿斯巴甜(2.5g)和羟丙基纤维素(2.5g)制成粉末。将所得粉末分别按每包2g的重量装入多个小包,从而制得散剂。
实施例13
颗粒剂:
采用常规方法将弗多司坦(120g)、对乙酰氨基酚(67.5g)、枸橼酸喷托维林(4.8g)、盐酸异西喷地(0.7g)、抗坏血酸钠(50g)、无水咖啡因(9g)、麻黄草干浸膏(40g)、甘草浸膏粉末(35.714g)、生姜粉(15g)、玉米淀粉(144.486g)、精制蔗糖(104.3g)、轻质二氧化硅(3g)、阿斯巴甜(3g)和羟丙基纤维素(2.5g)制成颗粒。将所得颗粒按每包2g的重量分别装入多个小包装,从而制得颗粒剂。
由于每种药用成分的作用均因另一种药用成分的存在而增强,本发明的以弗多司坦和解热/镇痛药为药用成分的药物组合物表现出极好的祛痰效果和抗炎效果。
因此,本发明的药物组合物作为一种治疗或缓解例如感冒等导致多痰的病症的药物,可有效地改善例如咽喉痛、多痰、寒战、发热、头痛、关节痛以及肌肉痛等普通感冒的症状,而且可有效地用作口服用的药物组合物。
Claims (5)
1.一种药物组合物,所述药物组合物包含弗多司坦和具有解热或镇痛作用的药物。
2.如权利要求1所述的药物组合物,其中所述的药物组合物是一种口服制剂。
3.如权利要求1或2所述的药物组合物,其中所述的药物组合物是一种感冒药。
4.如权利要求1至3中任一项所述的药物组合物,其中所述的具有解热或镇痛作用的药物是选自由阿司匹林、阿司匹林铝、对乙酰氨基酚、异丙安替比林、布洛芬、乙水杨胺、水杨酰水杨酸、水杨酰胺、水杨酸钠和乳酰乙氧苯胺组成的组的一种或多种化合物。
5.如权利要求1至4中任一项所述的药物组合物,所述的药物组合物还包含选自由抗组胺药、镇咳药、兴奋剂、维生素、生药和抗酸剂或粘膜保护剂组成的组的一种或多种药物。
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JP5796942B2 (ja) * | 2009-09-28 | 2015-10-21 | 興和株式会社 | ロキソプロフェン含有の医薬組成物 |
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WO2018183320A1 (en) * | 2017-03-31 | 2018-10-04 | Depco, Inc. | Therapeutic putty having analgesics and/or counterirritants |
CN109925300A (zh) * | 2017-12-19 | 2019-06-25 | 北京盈科瑞创新药物研究有限公司 | 一种福多司坦雾化吸入用溶液制剂及其制备方法 |
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-
2002
- 2002-05-24 JP JP2002592917A patent/JP4365107B2/ja not_active Expired - Lifetime
- 2002-05-24 US US10/477,757 patent/US20040147606A1/en not_active Abandoned
- 2002-05-24 CA CA002448081A patent/CA2448081A1/en not_active Abandoned
- 2002-05-24 CN CNB028106520A patent/CN1296040C/zh not_active Expired - Fee Related
- 2002-05-24 KR KR10-2003-7015167A patent/KR20040004638A/ko not_active Application Discontinuation
- 2002-05-24 WO PCT/JP2002/005042 patent/WO2002096406A1/ja not_active Application Discontinuation
- 2002-05-24 EP EP02726487A patent/EP1391201A4/en not_active Withdrawn
-
2004
- 2004-11-10 HK HK04108817A patent/HK1065944A1/xx not_active IP Right Cessation
Cited By (7)
Publication number | Priority date | Publication date | Assignee | Title |
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CN103083229A (zh) * | 2012-04-23 | 2013-05-08 | 重庆金邦动物药业有限公司 | 兽用复方安乃近注射液的制备方法 |
CN103083327A (zh) * | 2012-04-23 | 2013-05-08 | 重庆金邦动物药业有限公司 | 兽用复方安乃近注射液 |
CN103083338A (zh) * | 2012-04-23 | 2013-05-08 | 重庆金邦动物药业有限公司 | 增效复方安乃近注射液及其制备方法 |
CN103083229B (zh) * | 2012-04-23 | 2014-12-10 | 重庆金邦动物药业有限公司 | 兽用复方安乃近注射液的制备方法 |
CN102908328A (zh) * | 2012-11-19 | 2013-02-06 | 山东罗欣药业股份有限公司 | 一种福多司坦组合物片剂及其制备方法 |
CN106474130A (zh) * | 2016-08-31 | 2017-03-08 | 海南三风友制药有限公司 | 一种复方感冒口服溶液及其制备方法 |
CN107595930A (zh) * | 2017-10-17 | 2018-01-19 | 王龙 | 一种排痰药的制备方法 |
Also Published As
Publication number | Publication date |
---|---|
CN1296040C (zh) | 2007-01-24 |
EP1391201A4 (en) | 2004-06-30 |
CA2448081A1 (en) | 2002-12-05 |
EP1391201A1 (en) | 2004-02-25 |
WO2002096406A1 (fr) | 2002-12-05 |
HK1065944A1 (en) | 2005-03-11 |
KR20040004638A (ko) | 2004-01-13 |
US20040147606A1 (en) | 2004-07-29 |
JPWO2002096406A1 (ja) | 2004-09-09 |
JP4365107B2 (ja) | 2009-11-18 |
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