CN1212842C - Melazocine masticatory and its preparation - Google Patents
Melazocine masticatory and its preparation Download PDFInfo
- Publication number
- CN1212842C CN1212842C CN 03150528 CN03150528A CN1212842C CN 1212842 C CN1212842 C CN 1212842C CN 03150528 CN03150528 CN 03150528 CN 03150528 A CN03150528 A CN 03150528A CN 1212842 C CN1212842 C CN 1212842C
- Authority
- CN
- China
- Prior art keywords
- metadoxine
- chewable tablet
- tablet
- weight portion
- parts
- 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.)
- Expired - Lifetime
Links
- 238000002360 preparation method Methods 0.000 title abstract description 18
- RYKKQQUKJJGFMN-HVDRVSQOSA-N 4,5-bis(hydroxymethyl)-2-methylpyridin-3-ol;(2s)-5-oxopyrrolidine-2-carboxylic acid Chemical compound OC(=O)[C@@H]1CCC(=O)N1.CC1=NC=C(CO)C(CO)=C1O RYKKQQUKJJGFMN-HVDRVSQOSA-N 0.000 claims abstract description 90
- 239000007910 chewable tablet Substances 0.000 claims abstract description 67
- 229940068682 chewable tablet Drugs 0.000 claims abstract description 67
- 239000000796 flavoring agent Substances 0.000 claims abstract description 21
- 239000000945 filler Substances 0.000 claims abstract description 8
- 235000013355 food flavoring agent Nutrition 0.000 claims abstract description 8
- 238000000034 method Methods 0.000 claims abstract description 7
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 73
- 239000000576 food coloring agent Substances 0.000 claims description 18
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 18
- 229940109275 cyclamate Drugs 0.000 claims description 16
- HCAJEUSONLESMK-UHFFFAOYSA-N cyclohexylsulfamic acid Chemical compound OS(=O)(=O)NC1CCCCC1 HCAJEUSONLESMK-UHFFFAOYSA-N 0.000 claims description 16
- 239000008187 granular material Substances 0.000 claims description 16
- 239000000203 mixture Substances 0.000 claims description 16
- 239000007788 liquid Substances 0.000 claims description 14
- 235000009508 confectionery Nutrition 0.000 claims description 13
- 235000019634 flavors Nutrition 0.000 claims description 13
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims description 9
- 239000008101 lactose Substances 0.000 claims description 9
- 235000019359 magnesium stearate Nutrition 0.000 claims description 9
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 claims description 8
- 235000021355 Stearic acid Nutrition 0.000 claims description 8
- 239000011248 coating agent Substances 0.000 claims description 8
- 238000000576 coating method Methods 0.000 claims description 8
- 238000002156 mixing Methods 0.000 claims description 8
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 claims description 8
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 claims description 8
- 239000007779 soft material Substances 0.000 claims description 8
- 239000008117 stearic acid Substances 0.000 claims description 8
- 239000011230 binding agent Substances 0.000 claims description 7
- 229920001353 Dextrin Polymers 0.000 claims description 6
- 239000004375 Dextrin Substances 0.000 claims description 6
- 239000001856 Ethyl cellulose Substances 0.000 claims description 6
- 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 claims description 6
- 239000004378 Glycyrrhizin Substances 0.000 claims description 6
- 239000002202 Polyethylene glycol Substances 0.000 claims description 6
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 6
- 235000019425 dextrin Nutrition 0.000 claims description 6
- 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 claims description 6
- 229920001249 ethyl cellulose Polymers 0.000 claims description 6
- 235000019325 ethyl cellulose Nutrition 0.000 claims description 6
- LPLVUJXQOOQHMX-UHFFFAOYSA-N glycyrrhetinic acid glycoside Natural products C1CC(C2C(C3(CCC4(C)CCC(C)(CC4C3=CC2=O)C(O)=O)C)(C)CC2)(C)C2C(C)(C)C1OC1OC(C(O)=O)C(O)C(O)C1OC1OC(C(O)=O)C(O)C(O)C1O LPLVUJXQOOQHMX-UHFFFAOYSA-N 0.000 claims description 6
- 229960004949 glycyrrhizic acid Drugs 0.000 claims description 6
- UYRUBYNTXSDKQT-UHFFFAOYSA-N glycyrrhizic acid Natural products CC1(C)C(CCC2(C)C1CCC3(C)C2C(=O)C=C4C5CC(C)(CCC5(C)CCC34C)C(=O)O)OC6OC(C(O)C(O)C6OC7OC(O)C(O)C(O)C7C(=O)O)C(=O)O UYRUBYNTXSDKQT-UHFFFAOYSA-N 0.000 claims description 6
- 235000019410 glycyrrhizin Nutrition 0.000 claims description 6
- LPLVUJXQOOQHMX-QWBHMCJMSA-N glycyrrhizinic acid Chemical compound O([C@@H]1[C@@H](O)[C@H](O)[C@H](O[C@@H]1O[C@@H]1C([C@H]2[C@]([C@@H]3[C@@]([C@@]4(CC[C@@]5(C)CC[C@@](C)(C[C@H]5C4=CC3=O)C(O)=O)C)(C)CC2)(C)CC1)(C)C)C(O)=O)[C@@H]1O[C@H](C(O)=O)[C@@H](O)[C@H](O)[C@H]1O LPLVUJXQOOQHMX-QWBHMCJMSA-N 0.000 claims description 6
- 229920001223 polyethylene glycol Polymers 0.000 claims description 6
- 239000000741 silica gel Substances 0.000 claims description 6
- 229910002027 silica gel Inorganic materials 0.000 claims description 6
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims description 5
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims description 5
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims description 5
- FTLYMKDSHNWQKD-UHFFFAOYSA-N (2,4,5-trichlorophenyl)boronic acid Chemical compound OB(O)C1=CC(Cl)=C(Cl)C=C1Cl FTLYMKDSHNWQKD-UHFFFAOYSA-N 0.000 claims description 4
- 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 claims description 4
- 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 4
- ZZZCUOFIHGPKAK-UHFFFAOYSA-N D-erythro-ascorbic acid Natural products OCC1OC(=O)C(O)=C1O ZZZCUOFIHGPKAK-UHFFFAOYSA-N 0.000 claims description 4
- 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 description 4
- 229930195725 Mannitol Natural products 0.000 claims description 4
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 4
- 229920002472 Starch Polymers 0.000 claims description 4
- 229930006000 Sucrose Natural products 0.000 claims description 4
- 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 description 4
- 229930003268 Vitamin C Natural products 0.000 claims description 4
- TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 claims description 4
- 239000008103 glucose Substances 0.000 claims description 4
- 239000000594 mannitol Substances 0.000 claims description 4
- 235000010355 mannitol Nutrition 0.000 claims description 4
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 claims description 4
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 4
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 4
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 4
- 229940085605 saccharin sodium Drugs 0.000 claims description 4
- 239000000600 sorbitol Substances 0.000 claims description 4
- 239000008107 starch Substances 0.000 claims description 4
- 235000019698 starch Nutrition 0.000 claims description 4
- 239000005720 sucrose Substances 0.000 claims description 4
- 235000019154 vitamin C Nutrition 0.000 claims description 4
- 239000011718 vitamin C Substances 0.000 claims description 4
- 239000000811 xylitol Substances 0.000 claims description 4
- 235000010447 xylitol Nutrition 0.000 claims description 4
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 claims description 4
- 229960002675 xylitol Drugs 0.000 claims description 4
- 238000009495 sugar coating Methods 0.000 claims description 3
- 239000003795 chemical substances by application Substances 0.000 claims description 2
- 239000003826 tablet Substances 0.000 abstract description 27
- 239000003814 drug Substances 0.000 abstract description 25
- 230000000149 penetrating effect Effects 0.000 abstract description 5
- 230000008901 benefit Effects 0.000 abstract description 3
- 230000001055 chewing effect Effects 0.000 abstract description 3
- 238000005516 engineering process Methods 0.000 abstract description 3
- 239000003205 fragrance Substances 0.000 abstract description 3
- 230000009747 swallowing Effects 0.000 abstract description 2
- 206010036790 Productive cough Diseases 0.000 abstract 1
- 239000000853 adhesive Substances 0.000 abstract 1
- 230000001070 adhesive effect Effects 0.000 abstract 1
- 210000003238 esophagus Anatomy 0.000 abstract 1
- 230000002349 favourable effect Effects 0.000 abstract 1
- 235000019659 mouth feeling Nutrition 0.000 abstract 1
- 210000004400 mucous membrane Anatomy 0.000 abstract 1
- 210000003802 sputum Anatomy 0.000 abstract 1
- 208000024794 sputum Diseases 0.000 abstract 1
- 235000019605 sweet taste sensations Nutrition 0.000 abstract 1
- 238000009475 tablet pressing Methods 0.000 abstract 1
- 238000012360 testing method Methods 0.000 description 11
- 239000000049 pigment Substances 0.000 description 10
- 229940079593 drug Drugs 0.000 description 9
- 239000000523 sample Substances 0.000 description 7
- 210000004369 blood Anatomy 0.000 description 6
- 239000008280 blood Substances 0.000 description 6
- 238000004090 dissolution Methods 0.000 description 6
- 230000007062 hydrolysis Effects 0.000 description 6
- 238000006460 hydrolysis reaction Methods 0.000 description 6
- 239000000047 product Substances 0.000 description 6
- 210000000214 mouth Anatomy 0.000 description 5
- IKHGUXGNUITLKF-UHFFFAOYSA-N Acetaldehyde Chemical compound CC=O IKHGUXGNUITLKF-UHFFFAOYSA-N 0.000 description 4
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 4
- 239000002775 capsule Substances 0.000 description 4
- 210000004185 liver Anatomy 0.000 description 4
- LXNHXLLTXMVWPM-UHFFFAOYSA-N pyridoxine Chemical compound CC1=NC=C(CO)C(CO)=C1O LXNHXLLTXMVWPM-UHFFFAOYSA-N 0.000 description 4
- 244000144730 Amygdalus persica Species 0.000 description 3
- SEBIKDIMAPSUBY-ARYZWOCPSA-N Crocin Chemical compound C([C@H]1O[C@H]([C@@H]([C@@H](O)[C@@H]1O)O)OC(=O)C(C)=CC=CC(C)=C\C=C\C=C(/C)\C=C\C=C(C)C(=O)O[C@H]1[C@@H]([C@@H](O)[C@H](O)[C@@H](CO[C@H]2[C@@H]([C@@H](O)[C@H](O)[C@@H](CO)O2)O)O1)O)O[C@@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O SEBIKDIMAPSUBY-ARYZWOCPSA-N 0.000 description 3
- XINCECQTMHSORG-UHFFFAOYSA-N Isoamyl isovalerate Chemical compound CC(C)CCOC(=O)CC(C)C XINCECQTMHSORG-UHFFFAOYSA-N 0.000 description 3
- 241001093152 Mangifera Species 0.000 description 3
- 241000581835 Monodora junodii Species 0.000 description 3
- 235000006040 Prunus persica var persica Nutrition 0.000 description 3
- 235000009392 Vitis Nutrition 0.000 description 3
- 241000219095 Vitis Species 0.000 description 3
- 239000001055 blue pigment Substances 0.000 description 3
- 235000019219 chocolate Nutrition 0.000 description 3
- 239000013068 control sample Substances 0.000 description 3
- 239000006071 cream Substances 0.000 description 3
- QDOXWKRWXJOMAK-UHFFFAOYSA-N dichromium trioxide Chemical compound O=[Cr]O[Cr]=O QDOXWKRWXJOMAK-UHFFFAOYSA-N 0.000 description 3
- 239000012467 final product Substances 0.000 description 3
- 239000009627 gardenia yellow Substances 0.000 description 3
- 235000012907 honey Nutrition 0.000 description 3
- 238000005286 illumination Methods 0.000 description 3
- XMGQYMWWDOXHJM-UHFFFAOYSA-N limonene Chemical compound CC(=C)C1CCC(C)=CC1 XMGQYMWWDOXHJM-UHFFFAOYSA-N 0.000 description 3
- 239000007968 orange flavor Substances 0.000 description 3
- RZVAJINKPMORJF-UHFFFAOYSA-N Acetaminophen Chemical compound CC(=O)NC1=CC=C(O)C=C1 RZVAJINKPMORJF-UHFFFAOYSA-N 0.000 description 2
- RTZKZFJDLAIYFH-UHFFFAOYSA-N Diethyl ether Chemical compound CCOCC RTZKZFJDLAIYFH-UHFFFAOYSA-N 0.000 description 2
- 244000128206 Pyracantha coccinea Species 0.000 description 2
- KAESVJOAVNADME-UHFFFAOYSA-N Pyrrole Chemical compound C=1C=CNC=1 KAESVJOAVNADME-UHFFFAOYSA-N 0.000 description 2
- 230000001154 acute effect Effects 0.000 description 2
- 239000002671 adjuvant Substances 0.000 description 2
- 230000006870 function Effects 0.000 description 2
- FGIUAXJPYTZDNR-UHFFFAOYSA-N potassium nitrate Chemical compound [K+].[O-][N+]([O-])=O FGIUAXJPYTZDNR-UHFFFAOYSA-N 0.000 description 2
- 235000008160 pyridoxine Nutrition 0.000 description 2
- 239000011677 pyridoxine Substances 0.000 description 2
- 238000005070 sampling Methods 0.000 description 2
- 239000012047 saturated solution Substances 0.000 description 2
- 210000002966 serum Anatomy 0.000 description 2
- 239000011780 sodium chloride Substances 0.000 description 2
- 230000006641 stabilisation Effects 0.000 description 2
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- 238000011105 stabilization Methods 0.000 description 2
- 229940011671 vitamin b6 Drugs 0.000 description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 2
- ISBRQFNLCJBQKZ-UHFFFAOYSA-N 2-oxopyrrolidine-1-carboxylic acid;5-oxopyrrolidine-2-carboxylic acid Chemical compound OC(=O)C1CCC(=O)N1.OC(=O)N1CCCC1=O ISBRQFNLCJBQKZ-UHFFFAOYSA-N 0.000 description 1
- ODHCTXKNWHHXJC-VKHMYHEASA-N 5-oxo-L-proline Chemical class OC(=O)[C@@H]1CCC(=O)N1 ODHCTXKNWHHXJC-VKHMYHEASA-N 0.000 description 1
- QTBSBXVTEAMEQO-UHFFFAOYSA-M Acetate Chemical compound CC([O-])=O QTBSBXVTEAMEQO-UHFFFAOYSA-M 0.000 description 1
- 208000022309 Alcoholic Liver disease Diseases 0.000 description 1
- 208000007848 Alcoholism Diseases 0.000 description 1
- 102000005369 Aldehyde Dehydrogenase Human genes 0.000 description 1
- 108020002663 Aldehyde Dehydrogenase Proteins 0.000 description 1
- 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 1
- 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 1
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- 238000003379 elimination reaction Methods 0.000 description 1
- -1 erithritol Chemical compound 0.000 description 1
- 238000000605 extraction Methods 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- 210000003494 hepatocyte Anatomy 0.000 description 1
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Landscapes
- Medicinal Preparation (AREA)
Abstract
The present invention relates to a metadoxine chewable tablet and a preparation method thereof. The metadoxine chewable tablet is composed of metadoxine, a filling agent as a main medicine, corrigent, glidant, a flavoring agent and an adhesive. The metadoxine chewable tablet can be used for patients who have difficulty in swallowing common tablets, and the medicine elasticity is favorable. After put in a mouth for chewing, the metadoxine chewable tablet can dissolve in sputum. The metadoxine chewable tablet can be absorbed by a mucous membrane of a mouth cavity or an esophagus, and the biologic utilization degree is high. The metadoxine chewable tablet has the advantages of sweet taste, good mouth feelings, convenient administration and portability, and is prepared by a direct tablet pressing method. The penetrating odor is corrected, and the metadoxine chewable tablet has fragrance, and has the advantages of high stability, simple preparation technology and low cost.
Description
(1) technical field
The present invention relates to a kind of chewable tablet that contains metadoxine (Metadoxine) pharmacologically active component and preparation method thereof.
(2) background technology
Drink in population of China comparatively general and history more of a specified duration is arranged, along with people's raising of quality of life, the damage of drinking human body being caused more and more receives the concern of each side as the acute and chronic alcoholism of liver etc.But hepatoprotective medicine in the market is many after human body is subjected to certain damage, recovers the function of liver most possibly, so the degree of reversibility of recovering for liver function, most of people then still hold the suspection attitude.
Metadoxine (Metadoxine, pyridoxine L-2-pyrrolidone-5-carboxylic acid salt) be a kind of chemical compound of forming by pyrrole many hot (pyridoxine) and 2-pyrrolidone-5-carboxylic acid (pyrrolidone carboxylic acid), be a kind of metabolic balance medicine, the Biochemical Mechanism of alcoholic liver disease is had positive role.Liver ATP concentration is increased, and amino acid transport increases in the cell.And can obviously improve the activity of aldehyde dehydrogenase, and accelerate acetaldehyde and be metabolized to acetate, thereby quicken the removing of ethanol and acetaldehyde in blood plasma and the urine, recover the normal hepatocytes function, for prevention or delay the acute and chronic poisoning of liver ethanol positive clinical meaning is arranged.
Along with the prolongation of human average life and the decline of age growth swallow, the oral tablet administering mode becomes the problem that people pay close attention to.And according to estimates, have 50% people that swallow tablet or capsule are had any problem approximately, influenced the compliance of Drug therapy.In department of pediatrics and old medicine and pharmacology field, in water, dissolving or suspend, can chew or can in mouth, very big demand being arranged rapid dissolved solid preparation.Chewable tablet is as a kind of new dosage form, and it is by chewing in mouth or sucking and slowly taken, and can make medicine water and by oral not wherein, and it is sweet and fragrance, rapid-action, advantage that bioavailability is high arranged to have a sweet in the mouth.And the at present external commercially available metadoxine conventional tablet that is mainly, mouthfeel is poor, even the distinctive penetrating odor of medicine slightly, also there is not the chewable tablet preparation to occur, so be necessary to design that a kind of drug compliance is good, bioavailability is high, taking convenience and the good metadoxine chewable tablet preparation of mouthfeel.
(3) summary of the invention
The objective of the invention is to be to overcome metadoxine conventional tablet in the prior art swallow inconvenience, drug compliance is poor, bioavailability is low shortcoming, metadoxine chewable tablet that a kind of drug compliance is good, bioavailability is high, mouthfeel is good and preparation method thereof is provided.
For this reason, the technical solution used in the present invention is:
A kind of metadoxine chewable tablet, composed of the following components: weight portion is 200～800 parts a principal agent metadoxine, weight portion is 200～1200 parts a filler, weight portion is 5～200 parts a correctives, the fluidizer that weight portion is 2～80 parts, weight portion is 10～300 parts a flavoring agent, and weight portion is 2～100 parts a binding agent.Here used correctives is in order to improve the mouthfeel sense of taste of tablet, being adjusted to human body as far as possible easily accepts, flavoring agent is the penetrating odor that produces in order to metadoxine in the elimination tablet especially, makes this tablet before inlet, is difficult for being refused by the organum olfactorium of human body.In order to make the outward appearance of chewable tablet more beautiful, also can in the component of metadoxine chewable tablet, add weight portion and be 2～80 parts food coloring.
Described filler is as diluent, can select one of following formula or any two kinds or two or more mixture arbitrarily: 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. starch of erithritol of glucose of microcrystalline Cellulose of sorbitol of xylitol of mannitol of dextrin of sucrose of lactose.Wherein preferred lactose is a filler.
Described correctives is used for correcting because the poor taste that metadoxine or adjuvant bring, and can select one of following formula or any two kinds or two or more mixture arbitrarily: 1. 2. 4. 5. 6. vitamin C of thaumati of saccharin sodium of the sweet 3. glycyrrhizin of A Siba of cyclamate.
Be used for increasing the fluidizer of drug flow, can be one of following formula or any two kinds or two or more mixture arbitrarily: 1. 2. 3. 4. 5. stearic acid of Polyethylene Glycol of Pulvis Talci of micropowder silica gel of magnesium stearate.Wherein preferred magnesium stearate is a fluidizer.
In order to correct the flavoring agent of medicine penetrating odor, can accept the powdered flavor of taste with human body, as various fruity powdered flavors.
Binding agent in the prescription can be one of following formula or any two kinds or two or more mixture arbitrarily: 1. 2. 3. 4. 1～10% ethyl cellulose ethanol liquid of 1～10% polyvinylpyrrolidone ethanol liquid of 1～10% Polyethylene Glycol ethanol liquid of ethanol.Wherein preferred alcohol is a binding agent.
In addition, the food coloring in the medicament composing prescription is general human body acceptable pigment, as coloring agent, is used for improving the outward appearance of this preparation.
Described metadoxine chewable tablet more preferably component is made according to following prescription:
Metadoxine 200～800g
Lactose 200～1200g
Cyclamate 5～90g
Sweet 5～the 20g of A Siba
Magnesium stearate 2～80g
Powdered flavor 10～300g
Ethanol 2～100g
Food coloring 2～80g; Be pressed into the heavy slice, thin piece of 0.8～2.5g.
Preferred each set of dispense is than making by following prescription in the above-mentioned metadoxine chewable tablet component:
Metadoxine 500g
Lactose 600g
Cyclamate 90g
The sweet 20g of A Siba
Magnesium stearate 20g
Powdered flavor 100g
Ethanol 20g
Food coloring 10g
Make 1000.
The dosage of the film-making here can be adjusted on demand, owing to be chewable tablet, can make common sheet heavy prescription amount, also can be made into the special-shaped tablets more great than ordinary tablet, as can be made into polygon, capsule shape, circle, annular.
Prepare the method for above-mentioned prescription metadoxine chewable tablet, carry out according to following steps:
A. supplementary material is crossed 100 mesh sieves respectively;
B. metadoxine, filler, correctives mix homogeneously, add binding agent and make soft material, cross 20 mesh sieves and granulate, dry under 30～80 ℃ of vacuum conditions, cross 20 mesh sieves then and carry out granulate.
C. add fluidizer and flavoring agent, mixing.
D. be pressed into the heavy slice, thin piece of 0.8～2.5g.The slice, thin piece shape can be polygon, capsule shape, circle, annular and all rational shapes.
As having added food coloring in the prescription, then can in step b, add and add food coloring in the correctives.
But tablet is sugar coating also, can be behind the steps d tabletting sugar coating again, food coloring adds in the coating adjuvant.
The beneficial effect of metadoxine chewable tablet of the present invention and preparation method thereof is mainly reflected in: (1) the inconvenient patient of conventional tablet that can be used for swallowing, and drug compliance is good; (2) can be dissolved in saliva after putting into mouth and chewing, medicine can absorb the bioavailability height by oral cavity or intraesophageal mucosa; (3) not only the sweet mouthfeel of taste is good, and has corrected penetrating odor, and fragrance is arranged; (4) do not need drinking water also can take, taking convenience and being easy to carry; (5) adopt the direct compression process preparation, medicine stability is good, and production technology is simple, cost is low.
(4) specific embodiment
Embodiment 1
The preparation of metadoxine chewable tablet
1.1 prescription
Metadoxine 500g
Lactose 600g
Cyclamate 90g
The sweet 20g of A Siba
Magnesium stearate 20g
Fresh cream 100g
Ethanol 20g
Fructus Vitis viniferae pigment 10g
Be pressed into 1000 altogether
Wherein fresh cream is the powdered flavor that Hunan Shineway Enterprise Co., Ltd. produces, and the Fructus Vitis viniferae pigment is the food coloring that Wuhan Branch of the Chinese Academy of Sciences produces.
1.2 prepare the metadoxine chewable tablet of above-mentioned prescription, carry out according to following steps:
1.2.1 supplementary material is crossed 100 mesh sieves respectively;
1.2.2, add ethanol and make soft material metadoxine, lactose, cyclamate, sweet, the Fructus Vitis viniferae pigment mix homogeneously of A Siba, cross 20 mesh sieves and granulate, dry under 50 ℃ of vacuum conditions, cross 20 mesh sieves then and carry out granulate.
1.2.3 add magnesium stearate and fresh cream, mixing.
1.2.4 be pressed into the heavy olive shape slice, thin piece of 1.4g.
Embodiment 2
The preparation of metadoxine chewable tablet
2.1 prescription
Metadoxine 300g
Dextrin 450g
Cyclamate 20g
Glycyrrhizin 30g
Micropowder silica gel 18g
Green apple essence 60g
5% ethyl cellulose ethanol liquid 20g
Fructus Gardeniae blue pigment 5g
Be pressed into 1000 altogether
Wherein green apple essence is the powdered flavor that Hunan Shineway Enterprise Co., Ltd. produces, and the Fructus Gardeniae blue pigment is the food coloring that Wuhan Branch of the Chinese Academy of Sciences produces.
2.2 prepare the metadoxine chewable tablet of above-mentioned prescription, carry out according to following steps:
2.2.1 supplementary material is crossed 100 mesh sieves respectively;
2.2.2, add 5% ethyl cellulose ethanol liquid and make soft material metadoxine, dextrin, cyclamate, glycyrrhizin, Fructus Gardeniae blue pigment mix homogeneously, cross 20 mesh sieves and granulate, dry under 40 ℃ of vacuum conditions, cross 20 mesh sieves then and carry out granulate.
2.2.3 add micropowder silica gel and green apple essence, mixing.
2.2.4 be pressed into the heavy capsule shape slice, thin piece of 1.2g.
Embodiment 3
The preparation of metadoxine chewable tablet
3.1 prescription
Metadoxine 750g
Mannitol 1000g
Erithritol 100g
Cyclamate 100g
Stearic acid 60g
Orange flavor 100g
5% polyvinylpyrrolidone ethanol liquid 100g
Gardenia yellow pigment 60g
Be pressed into 1000 altogether
Wherein orange flavor is the powdered flavor that Hunan Shineway Enterprise Co., Ltd. produces, and the gardenia yellow pigment is the food coloring that Wuhan Branch of the Chinese Academy of Sciences produces.
3.2 prepare the metadoxine chewable tablet of above-mentioned prescription, carry out according to following steps:
3.2.1 supplementary material is crossed 100 mesh sieves respectively;
3.2.2, add 5% polyvinylpyrrolidone ethanol liquid and make soft material metadoxine, mannitol, erithritol, cyclamate mix homogeneously, cross 20 mesh sieves and granulate, dry under 55 ℃ of vacuum conditions, cross 20 mesh sieves then and carry out granulate.
3.2.3 add stearic acid and orange flavor, mixing.
3.2.4. be pressed into the heavy octagonal slice, thin piece of 2.03g, carry out coating, add the gardenia yellow pigment during coating, get final product.
Embodiment 4
The preparation of metadoxine chewable tablet
4.1 prescription
Metadoxine 780g
Xylitol 600g
Microcrystalline Cellulose 600g
The sweet 100g of A Siba
Saccharin sodium 80g
Pulvis Talci 40g
Stearic acid 30g
Honey peach essence 250g
2% ethyl cellulose ethanol liquid 90g
The plain 40g of leaf green
Make 1000 altogether
Wherein honey peach essence is the powdered flavor that Hunan Shineway Enterprise Co., Ltd. produces, and the leaf green element is the food coloring that Wuhan Branch of the Chinese Academy of Sciences produces.
4.2 prepare the metadoxine chewable tablet of above-mentioned prescription, carry out according to following steps:
4.2.1 supplementary material is crossed 100 mesh sieves respectively;
4.2.2, add 2% ethyl cellulose ethanol liquid and make soft material metadoxine, xylitol, microcrystalline Cellulose, sweet, the saccharin sodium mix homogeneously of A Siba, cross 20 mesh sieves and granulate, dry under 35 ℃ of vacuum conditions, cross 20 mesh sieves then and carry out granulate.
4.2.3 add Pulvis Talci, stearic acid and honey peach essence, mixing.
4.2.4 be pressed into the heavy octagonal slice, thin piece of 2.45g, carry out coating, add the leaf green element during coating amount, get final product.
Embodiment 5
The preparation of metadoxine chewable tablet
5.1 prescription
Metadoxine 250g
Sucrose 200g
Dextrin 100g
Glucose 200g
Cyclamate 10g
Thaumati 5g
Polyethylene Glycol 20g
Chocolate essence 20g
8% polyvinylpyrrolidone ethanol liquid 10g
Monascorubin 30g
Make 1000 altogether
Wherein chocolate essence is the powdered flavor that Hunan Shineway Enterprise Co., Ltd. produces, and monascorubin is the food coloring that Wuhan Branch of the Chinese Academy of Sciences produces.
5.2 prepare the metadoxine chewable tablet of above-mentioned prescription, carry out according to following steps:
5.2.1 supplementary material is crossed 100 mesh sieves respectively;
5.2.2, add 8% polyvidon ethanol liquid and make soft material metadoxine, sucrose, dextrin, glucose, cyclamate, thaumati mix homogeneously, cross 20 mesh sieves and granulate, dry under 60 ℃ of vacuum conditions, cross 20 mesh sieves then and carry out granulate.
5.2.3 add Polyethylene Glycol and chocolate essence, mixing.
5.2.4 be pressed into the heavy circular slice, thin piece of 0.85g, carry out coating, add monascorubin during coating, get final product.
Embodiment 6
The preparation of metadoxine chewable tablet
6.1 prescription
Metadoxine 400g
Sorbitol 300g
Starch 200g
Cyclamate 50g
Glycyrrhizin 20g
Vitamin C 20g
Micropowder silica gel 10g
Pulvis Talci 10g
Stearic acid 10g
Fructus Mangifera Indicae essence 80g
Ethanol 20g
Pyracantha pigment 10g
Be pressed into 1000 altogether
Wherein Fructus Mangifera Indicae essence is the powdered flavor that Hunan Shineway Enterprise Co., Ltd. produces, and pyracantha pigment is the food coloring that Wuhan Branch of the Chinese Academy of Sciences produces.
6.2 prepare the metadoxine chewable tablet of above-mentioned prescription, carry out according to following steps:
6.2.1 supplementary material is crossed 100 mesh sieves respectively;
6.2.2, add ethanol and make soft material metadoxine, sorbitol, starch, cyclamate, glycyrrhizin, vitamin C, pyracantha pigment mix homogeneously, cross 20 mesh sieves and granulate, dry under 75 ℃ of vacuum conditions, cross 20 mesh sieves then and carry out granulate.
6.2.3 add micropowder silica gel, Pulvis Talci, stearic acid and Fructus Mangifera Indicae essence, mixing.
6.2.4. be pressed into the heavy hexagon slice, thin piece of 1.2g.
Embodiment 7 metadoxine chewable tablet and the ordinary tablet stability under high light relatively
Get embodiment 1 chewable tablet and ordinary tablet (being provided by Zhejiang Zhenyuan Pharmaceutical Co., Ltd) sample is an amount of, be tiled in the plate, under 4500Lx illuminance light, placed 10 days, and the sampling at interval in the 0th, 1,3,5,10 day, measure.The results are shown in Table 1 and table 2
Table 1, metadoxine chewable tablet strong illumination result of the test
Branch standing time (falling) hydrolysis products dissolution (%) content
(my god) (%) (45min) (being equivalent to labelled amount 100%)
0 0.36 99.8 108.3
1 0.12 102.9 107.7
3 0.26 102.3 107.7
5 0.36 105.1 106.0
10 0.52 99.2 105.4
Table 2, metadoxine ordinary tablet strong illumination result of the test
Branch standing time (falling) hydrolysis products dissolution (%) content
(my god) (%) (45min) (being equivalent to labelled amount 100%)
0 0.35 99.9 104.0
1 0.24 99.6 109.7
3 0.38 102.5 102.7
5 0.59 108.2 99.5
10 1.25 107.2 82.3
As seen: under equal intensity of illumination, the metadoxine chewable tablet is more stable than metadoxine ordinary tablet.
Embodiment 8 metadoxine chewable tablet and ordinary tablet stability at high temperature relatively
It is an amount of to get embodiment 1 chewable tablet and ordinary tablet sample, puts respectively in 40 ℃, 60 ℃ and the 80 ℃ of calorstats, places 10 days, and the sampling at interval in the 0th, 1,3,5,10 day, measures.The results are shown in Table 3 and table 4.
Table 3, metadoxine chewable tablet heat stabilization test result
Laying temperature outward appearance standing time branch (falling) hydrolysis products dissolution (45min) content
(my god) (%) (%) (be equivalent to labelled amount
100％)
40 ℃ 0 good 0.36 99.2 108.3
1 good 0.47 98.9 107.5
3 good 0.30 100.2 108.2
5 good 0.54 101.0 108.3
10 good 0.36 100.1 107.9
60 ℃ 0 good 0.36 99.9 108.3
1 good 0.26 99.8 107.8
3 good 0.49 102.2 108.2
5 good 0.52 104.2 107.9
10 good 0.59 106.2 106.0
80 ℃ 0 good 0.36 100.2 108.3
1 good 0.59 100.6 100.8
3 slightly soften 1.02 108.3 99.5
5 slightly soften 3.40 89.1 98.5
10 softening 5.6 survey survey
Table 4 metadoxine ordinary tablet heat stabilization test result
Laying temperature outward appearance standing time branch (falling) hydrolysis products dissolution (45min) content
(my god) (%) (%) (be equivalent to the mark
The amount of showing 100%)
40 ℃ 0 good 0.35 100.5 108.0
1 good 0.40 100.9 109.5
3 good 0.35 101.2 106.2
5 good 0.57 99.9 107.3
10 good 0.42 99.6 107.0
60 ℃ 0 good 0.22 99.3 108.3
1 good 0.29 100.8 105.0
3 good 0.37 100.6 107.2
5 slightly soften 1.80 92.3 100.9
10 slightly soften 3.74 93.2 96.0
80 ℃ 0 good 0.36 99.6 108.3
1 slightly softens 2.59 93.2 " 100.8
3 softening 15.02 89.2 79.5
5 softening surveys are surveyed survey
10 softening surveys are surveyed survey
Above result as seen, under 40 ℃ of conditions, the heat stability basically identical of metadoxine chewable tablet and ordinary tablet, but under 60 ℃ and 80 ℃ of hot conditionss, the heat stability of metadoxine chewable tablet is obviously good than ordinary tablet.
Embodiment 9 metadoxine chewable tablet and the ordinary tablet stability under super-humid conditions relatively
Prepare sodium chloride saturated solution (RH75%) respectively and potassium nitrate saturated solution (RH92.5%) is put in the exsiccator, get metadoxine chewable tablet sample and the ordinary tablet sample of embodiment 1, in the horizontalization ware, put into dry airtight, placed 10 days, and took a sample at interval in the 0th, 1,3,5,10 day, measure.The results are shown in Table 5 and table 6.
Table 5, metadoxine chewable tablet high humidity stability test result
Relative humidity outward appearance standing time branch (falling) hydrolysis products dissolution (45min) content
(my god) (%) (%) (be equivalent to
Labelled amount 100%)
75% 0 normal 0.36 99.7 108.3
1 normal 0.40 100.8 108.1
3 normal 0.35 101.8 107.8
5 normal 0.32 102.6 107.8
10 normal 0.54 100.2 107.7
92.5% 0 normal 0.36 100.1 108.3
1 normal 0.22 100.1 108.0
3 normal 0.33 99.9 106.0
5 make moist 0.44 92.5 105.9
10 make moist 0.66 91.0 100.3
Table 6, metadoxine ordinary tablet high humidity stability test result
Relative humidity outward appearance standing time branch (falling) hydrolysis products dissolution (45min) content
(my god) (%) (%) (be equivalent to
Labelled amount 100%)
75% 0 normal 0.28 100.6 108.3
1 normal 0.44 100.8 106.0
3 normal 0.30 100.9 108.8
5 normal 0.38 99.0 102.9
10 make moist 0.56 89.0 97.1
92.5% 0 normal 0.29 100.2 108.3
1 normal 0.32 100.3 105.0
3 make moist 0.38 96.6 102.0
5 make moist 0.89 92.3 91.2
10 very damp 2.36 86.3 79.6
Embodiment 10 metadoxine chewable tablet and the comparative test of ordinary tablet human bioavailability
1. the experimenter selects:
Select health to be tried volunteer 10 people, tried to reach in the last week duration of test and do not take any other medicine, tried fasting in preceding 12 hours.
2. sample:
The I test specimen embodiment of the invention 1 metadoxine chewable tablet
The metadoxine tablet that II control sample Zhejiang Zhenyuan Pharmaceutical Co., Ltd provides
3. method of testing:
Test specimen I and each 1g of control sample II are taken in twice test of experimenter respectively, twice intertrial interval 3 days, take medicine get the blood time be h (hour): 0.25,0.5,1,1.5,2.5,5,8,12 equal extracting vein blood 3ml, centrifuging and taking serum, blood serum sample is handled; Quantitatively get serum, handle through NaCl, the centrifuging and taking upper organic phase is measured absorption value behind the ether extraction in the 248nm place, measures human body blood drug level.See Table 7;
4. result of the test:
From table 7 test data obviously as seen, chewable tablet I of the present invention is within taking medicine back 0.5 hour, and the blood drug level C of human body illustrates that than ordinary tablet II height chewable tablet of the present invention is absorbed easily, has rapid-action characteristics.By calculating, the bioavailability of common metadoxine sheet is 100% o'clock, and the bioavailability of chewable tablet of the present invention is 109.3, proves that chewable tablet of the present invention has high bioavailability, and these computational methods are
Prior art is not so describe in detail.
Different time human body blood drug level (um/mg) after table 7 is taken medicine
I is a chewable tablet of the present invention;
II is the control sample ordinary tablet;
H is for taking medicine the back time;
C is human body blood drug level (um/mg);
N is experimenter's numbering.
Claims (12)
1. metadoxine chewable tablet is characterized in that described metadoxine chewable tablet is composed of the following components:
Weight portion is 200～800 parts a principal agent metadoxine,
Weight portion is 200～1200 parts a filler,
Weight portion is 5～200 parts a correctives,
The fluidizer that weight portion is 2～80 parts,
Weight portion is 10～300 parts a flavoring agent,
Weight portion is 2～100 parts a binding agent.
2. metadoxine chewable tablet as claimed in claim 1, it is characterized in that also having in the described component: weight portion is 2～80 parts a food coloring.
3. metadoxine chewable tablet as claimed in claim 1 or 2 is characterized in that described filler is one of following formula or any two kinds or any two or more mixture:
1. 2. 3. 4. 5. 6. 7. 8. 9. 10. starch of erithritol of glucose of microcrystalline Cellulose of sorbitol of xylitol of mannitol of dextrin of sucrose of lactose.
4. metadoxine chewable tablet as claimed in claim 1 or 2 is characterized in that described correctives is one of following formula or any two kinds or any two or more mixture:
1. 2. 4. 5. 6. vitamin C of thaumati of saccharin sodium of the sweet 3. glycyrrhizin of A Siba of cyclamate.
5. metadoxine chewable tablet as claimed in claim 1 or 2 is characterized in that described fluidizer is one of following formula or any two kinds or any two or more mixture:
1. 2. 3. 4. 5. stearic acid of Polyethylene Glycol of Pulvis Talci of micropowder silica gel of magnesium stearate.
6. metadoxine chewable tablet as claimed in claim 1 is characterized in that described binding agent is one of following formula or any two kinds or any two or more mixture:
1. 2. 3. 4. 1～10% ethyl cellulose ethanol liquid of 1～10% polyvinylpyrrolidone ethanol liquid of 1～10% Polyethylene Glycol ethanol liquid of ethanol.
7. metadoxine chewable tablet as claimed in claim 1 is characterized in that described flavoring agent is the powdered flavor that human body can be accepted taste.
8. metadoxine chewable tablet as claimed in claim 2 is characterized in that described metadoxine chewable tablet makes by following prescription:
Metadoxine 200～800g
Lactose 200～1200g
Cyclamate 5～90g
Sweet 5～the 20g of A Siba
Magnesium stearate 2～80g
Powdered flavor 10～300g
Ethanol 2～100g
Food coloring 2～80g
Be pressed into the heavy slice, thin piece of 0.8～2.5g.
9. metadoxine chewable tablet as claimed in claim 8 is characterized in that described metadoxine chewable tablet makes by following prescription:
Metadoxine 500g
Lactose 600g
Cyclamate 90g
The sweet 20g of A Siba
Magnesium stearate 20g
Powdered flavor 100g
Ethanol 20g
Food coloring 10g
Make 1000.
10. method for preparing metadoxine chewable tablet as claimed in claim 1 or 2 is characterized in that described method carries out according to the following steps order:
A. supplementary material is crossed 100 mesh sieves respectively;
B. metadoxine, filler, correctives mix homogeneously, add binding agent and make soft material, cross 20 mesh sieves and granulate, dry under 30～80 ℃ of vacuum conditions, cross 20 mesh sieves then and carry out granulate;
C. add fluidizer and flavoring agent, mixing;
D. be pressed into the heavy slice, thin piece of 0.8～2.5g.
11., also add food coloring when it is characterized in that adding correctives among the step b as preparing the method for metadoxine chewable tablet as described in the claim 10.
12. as preparing the method for metadoxine chewable tablet as described in the claim 10, it is characterized in that behind the steps d tabletting sugar coating again, described food coloring adds when coating.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 03150528 CN1212842C (en) | 2003-08-20 | 2003-08-20 | Melazocine masticatory and its preparation |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 03150528 CN1212842C (en) | 2003-08-20 | 2003-08-20 | Melazocine masticatory and its preparation |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1490006A CN1490006A (en) | 2004-04-21 |
| CN1212842C true CN1212842C (en) | 2005-08-03 |
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| CN 03150528 Expired - Lifetime CN1212842C (en) | 2003-08-20 | 2003-08-20 | Melazocine masticatory and its preparation |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1301108C (en) * | 2004-10-15 | 2007-02-21 | 山东齐都药业有限公司 | Metadoxine dispersible tablet and preparation method thereof |
| IL187159A0 (en) * | 2007-07-03 | 2009-02-11 | Gur Megiddo | Use of metadoxine in relief of alcohol intoxication |
| CN102008448A (en) * | 2010-06-30 | 2011-04-13 | 吴光彦 | Metadoxine granules and preparation and quality control method thereof |
| CN103948554A (en) * | 2014-04-18 | 2014-07-30 | 赵辉 | Anastrozole chewable tablet and preparation method for same |
| CN103948549A (en) * | 2014-04-18 | 2014-07-30 | 赵辉 | Exemestane chewable tablet and preparation method for same |
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2003
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