The medicine composition which contains [rehuamechinibu] 机翻标题: 暂无翻译,请尝试点击翻译按钮。

源语言标题
(JP2016531151) レファメチニブ​を​含有​する​医薬​組成​物
公开号/公开日
JP2016531151 A 2016-10-06 [JP2016531151] / 2016-10-06
申请号/申请日
2016JP-0542319 / 2014-09-11
发明人
;
申请人
BAYER HEALTHCARE PHARMACEUTICALS;
主分类号
IPC分类号
A61K-009/30A61K-031/18A61K-047/02A61K-047/04A61K-047/06A61K-047/10A61K-047/12A61K-047/14A61K-047/18A61K-047/20A61K-047/22A61K-047/24A61K-047/26A61K-047/32A61K-047/34A61K-047/36A61K-047/38A61K-047/46A61P-035/00
摘要
(JP2016531151) The present invention relates to pharmaceutical compositions which contain refametinib, a hydrate, solvate, meta bolite or pharmaceutically acceptable salt thereof or a polymorph thereof, and which are coated with a stability-maintaining coating, to processes of preparing such compositions, and to uses of such compositions for treating hyper-proliferative disorders and/or angiogenesis disorders, such as cancer, either as a sole agent or in combination with other anti-cancer therapies.  (From US2016220494 A1)
机翻摘要
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地址
代理人
代理机构
;
优先权号
2013EP-0184229 2013-09-13 2013EP-0184539 2013-09-16 2014WO-EP69453 2014-09-11
主权利要求
(JP2016531151)  1. The nucleus which includes below: o [rehuamechinibu], that hydrate, the solvent dishes dressed with sauce, the multiformity and the metabolite or that salt which is allowed pharmacy;  And 1 or the nuclear *** shape medicine where plural is allowed pharmacy;  And The polyethylene glycol which includes below the stability maintenance coating which is not included: The stability maintenance film formation medicine which is the o hydroxypropyl methyl cellulose;   The o furthermore the stability maintenance film formation medicine which it is good including;   o and, 1 or it is good including the coating *** shape medicine where plural is allowed pharmacy It includes, the coating lock. 2. Aforementioned [rehuamechinibu] to particulate features that it is the form which is converted, in claim 1 the coating lock of statement. 3. It features that aforementioned [rehuamechinibu] is form of multiformity A, in claim 1 or 2 the coating lock of statement. 4. The aforementioned further stability maintenance film formation medicine: For example hydroxyethyl cellulose, hydroxypropyl cellulose and methyl cellulose, poly- vinyl alcohol (PVA), copolymer of poly- vinyl pyrolidone, vinyl pyrolidone and vinyl acetate (for example Kollidon (registered trade mark) VA64 BASF and the like), copolymer of vinyl pyrolidone and vinyl acetate sucrose, polyacrylate and poly- methacrylate (acrylic acid and/or copolymer of methacrylic acid ester and copolymer, dimethyl amino methacrylic acid and neutral methacrylic acid ester of [torimechiruanmoniumumechiruakurireto], polymer of methacrylic acid or methacrylic acid ester, copolymer and liquefied glucose of copolymer, acrylic acid and methyl acrylate ester of copolymer, methacrylic acid and methyl acrylate ester of ethyl acrylate ester and methyl methacrylate ester, ethyl cellulose, cellulose acetate phthalate, [hidorokishipuropirumechiruserurosuasetetosukushineto],It features that it is selected from hydroxypropyl methyl cellulose phthalate and the group which consists of the shellac or those blends, claim 1, 2 or 3 either in one section the coating lock of statement. 5. The aforementioned further stability maintenance film formation medicine poly- vinyl alcohol (PVA) features that is, from claim 1 either of 4 in one section the coating lock of statement. 6. The aforementioned hydroxypropyl methyl cellulose, the aforementioned polyethylene glycol 100 weight % features that it exists at the quantity from 30 of the stability maintenance coating which is not included, from claim 1 either of 5 in one section the coating lock of statement. 7. The aforementioned hydroxypropyl methyl cellulose, the aforementioned polyethylene glycol 55 weight % features that it exists at the quantity from 40 of the stability maintenance coating which is not included, from claim 1 either of 6 in one section the coating lock of statement. 8. The nucleus which includes below: o [rehuamechinibu], that hydrate, the solvent dishes dressed with sauce, the multiformity and the metabolite or that salt which is allowed pharmacy;  And 1 or the nuclear *** shape medicine where plural is allowed pharmacy;  And The stability maintenance coating which includes below: o poly- vinyl alcohol, the stability maintenance film formation medicine which is the poly- vinyl alcohol which adding water was disassembled especially partly;   The o furthermore the stability maintenance film formation medicine which it is good including;   The plasticizer which is o polyethylene glycol;   o and, 1 or it is good including the coating *** shape medicine where plural is allowed pharmacy It includes, the coating lock. 9. Aforementioned [rehuamechinibu] to particulate features that it is the form which is converted, in claim 8 the coating lock of statement. 10. It features that aforementioned [rehuamechinibu] is form of multiformity A, in claim 8 or 9 the coating lock of statement. 11. It features that the aforementioned stability maintenance film formation medicine is, poly- vinyl alcohol (the part hydrolysate) (PVA) from 40 of the aforementioned stability maintenance coating 55 weight % exists desirably at the quantity, from claim 8 either of 10 in one section the coating lock of statement. 12. The aforementioned further stability maintenance film formation medicine: For example hydroxyethyl cellulose, hydroxypropyl cellulose and methyl cellulose, copolymer of poly- vinyl pyrolidone, vinyl pyrolidone and vinyl acetate (for example Kollidon (registered trade mark) VA64 BASF and the like), copolymer of vinyl pyrolidone and vinyl acetate sucrose, polyacrylate and poly- methacrylate (acrylic acid and/or copolymer of methacrylic acid ester and copolymer, dimethyl amino methacrylic acid and neutral methacrylic acid ester of [torimechiruanmoniumumechiruakurireto], polymer of methacrylic acid or methacrylic acid ester, copolymer and liquefied glucose of copolymer, acrylic acid and methyl acrylate ester of copolymer, methacrylic acid and methyl acrylate ester of ethyl acrylate ester and methyl methacrylate ester, ethyl cellulose, cellulose acetate phthalate, [hidorokishipuropirumechiruserurosuasetetosukushineto], hydroxypropyl methyl cellulose phthalate and shellac,Or it features that it is selected from the group which consists of those blends, from claim 8 either of 11 in one section the coating lock of statement. 13. Exists in the aforementioned stability maintenance coating the description above 1 which or plural is allowed pharmacy the coating *** shape medicine where: * 1 where it is not polyethylene glycol or the plural plasticizers;   *1 or plural coloration charges;   *1 or plural anti arrival medicines;  And *1 or plural opacefiers It features that it is selected from the group which consists of, from claim 1 either of 12 in one section the coating lock of statement. 14. The description above 1 or plural plasticizers: Propylene glycol, polypropylene glycol, sorbitol, the glycerine and multiple tall, [kishiritoru], mannitol and Eli pickpocket tall, [guriserorutorioreeto], citric acid tributyl, citric acid triethyl and acetyl citric acid triethyl, [guriserirutoriaseteto], it features that it is selected from the group which consists of stearic acid, medium chain triglyceride or those blends, in claim 13 the coating lock of statement. 15. The description above 1 or the plural plasticizers 35 weight % feature that it exists at the gross from 0 of the aforementioned stability maintenance coating, in claim 149 the coating lock of statement. 16. The description above 1 or plural coloration charges: Nature or the dye or the pigment of synthesis, for example red iron oxide, yellow iron oxide, black iron oxide and titanium dioxide, the indigo chin, sun set yellow FCF, [tarutorajin] and [erisuroshin], quinoline yellow and carbon black, the anthocyanin, the riboflavin, the carmine, curcumine, the chlorophyll and the carotin etc, or those blends, desirably titanium dioxide and iron oxide, it features that it is selected from the group which for example consists of, to be more desirable iron oxide and titanium dioxide such as yellow iron oxide, red iron oxide and/or black iron oxide, from claim 13 either of 15 in one section the coating lock of statement. 17. The description above 1 or plural coloration charges, 50 weight %, feature that from 15 45 weight % it exists desirably at the gross from 10 of the aforementioned stability maintenance coating, in claim 16 the coating lock of statement. 18. The description above 1 or plural anti arrival medicines: The talc and stearic acid magnesium, stearic acid, the lecithin and the soy bean lecithin, the mineral oil and the carnauba wax, acetylation mono glyceride and/or the poly- solvate or those blends, desirably the talc, the lecithin and the soy bean lecithin and/or the poly- solvate or those blends, to be more desirable it features that it is selected from the group which consists of the talc, the lecithin and the soy bean lecithin, from claim 13 either of 17 in one section the coating lock of statement. 19. The description above 1 or the plural anti arrival medicines, 40 weight %, feature that from 3 25 weight % it exists desirably at the gross from 1 of the aforementioned stability maintenance coating, in claim 18 the coating lock of statement. 20. The description above 1 or plural opacefiers: It features that it is selected from the group which consists of the talc and titanium dioxide, from claim 13 either of 19 in one section the coating lock of statement. 21. The description above 1 or the plural opacefiers, 60 weight % feature that it exists at the gross from 10 of the aforementioned stability maintenance coating, in claim 20 the coating lock of statement. 22. Exists in the aforementioned nucleus the description above 1 which or plural is allowed pharmacy the nuclear *** shape medicine where: *1 or plural dust diluents or dry binder;   *1 or plural collapse medicines;   The *1 or plural surface active agents, especially the penetrant;   *1 or plural binders (for wet granulation);   *1 or plural lubricants It features that it is selected from the group which consists of, from claim 1 either of 21 in one section the coating lock of statement. 23. The aforementioned dust diluent or dry binder: (For example) the powder cellulose, the crystallite characteristic cellulose, the silicide conversion crystallite characteristic cellulose and the ethyl cellulose, phosphoric acid two calcium and phosphoric acid three calcium, the kaolin and three silica magnesium, mannitol, sorbitol and multiple tall, [kishiritoru], the lactose, dextroglucose and the maltose, sucrose, glucose, fructose or [marutodekisutorin] precipitated calcium carbonate, sodium carbonate, the sodium phosphate and the starch, desirably the crystallite characteristic cellulose, mannitol, and/or the lactose, to be more desirable mannitol and the crystallite characteristic cellulose and/or it features that it is selected from the group which consists of the lactose as an anhydrous shape or a hydrate and for example one hydrate shape etc,In claim 22 coating lock of statement. 24. The aforementioned dust diluent or the dry binder, 95 weight %, features that from 30 80 weight % it exists desirably at the quantity from 0 of gross weight of the aforementioned nucleus, in claim 23 the coating lock of statement. 25. The aforementioned collapse medicine: [kurosukarumerosunatoriumu] and [kurosupobidon] (building a bridge poly- vinyl pyrolidone), the glycol acid starchy sodium, carboxymethyl cellulose calcium, the carboxymethyl cellulose sodium, the crystallite characteristic cellulose, the hydroxypropyl cellulose, the starch, the carboxymethyl starchy sodium and the starch which the degree of substitution hydroxypropyl cellulose, [porakuririnkariumu], alginic acid and the alginic acid sodium, adding water were disassembled low partly, desirably [kurosukarumerosunatoriumu] and/or [kurosupobidon], it features that more desirably it is selected from the group which consists of [kurosukarumerosunatoriumu], from claim 22 either of 24 in one section the coating lock of statement. 26. The aforementioned collapse medicine, 15 weight %, features that from 3 10 weight % it exists desirably at the quantity from 0 of gross weight of the aforementioned nucleus, in claim 25 the coating lock of statement. 27. The aforementioned penetrant (or "surface active agent"): [heputadekaechirenokishisetanoru], lecithin, stearic acid polyoxyethylene, [nonokishinoru] 9, [nonokishinoru] 10, [okusutokishinoru] (oxtoxynol) 9, sorbitan fatty acid ester, for example Span20, 40, 60, 80 or 85, poly- solvate, for example poly- solvate 20, 21, 40, 60, 61, 65 or 80, copolymer of ester, ethylene oxide and propylene oxide of ether, fatty acid and polyoxyethylene of fatty alcohol and polyoxyethylene such as part ester of fatty acid and alcohol such as sodium salt of sulfonic succinic acid such as sodium salt of fatty alcohol sulfuric acid and for example lauryl sodium sulfate and for example dioctyl sulfonic succinic acid sodium and for example mono stearic acid glycerine (Pluronic (registerTrade mark))The chloridation benzal conium and [etokishiru] conversion triglyceride, it features that desirably it is selected from the group which consists of the lauryl sodium sulfate, from claim 22 either of 26 in one section the coating lock of statement. 28. The aforementioned penetrant, 5 weight %, features that from 0.1 2 weight % it exists desirably at the quantity from 0 of gross weight of the aforementioned nucleus, in claim 27 the coating lock of statement. 29. The aforementioned binder (for wet granulation): The hydroxypropyl cellulose, [hipuromerosu] (the hydroxypropyl methyl cellulose, HPMC), the hydroxyethyl cellulose and the carboxymethyl cellulose, carboxymethyl cellulose calcium, the carboxymethyl cellulose sodium, the ethyl cellulose and the methyl cellulose, [pobidon] (poly- vinyl pyrolidone, PVP), poly- vinyl alcohol, the polyacrylate and the gelatin, liquefied glucose, the gum arabic, alginic acid and the I conversion starch, desirably the hydrophilic binder which is soluble in the water granulation liquid, to be more desirable [hipuromerosu] (the hydroxypropyl methyl cellulose, HPMC) and/or poly- vinyl pyrolidone, it features that furthermore more desirably it is selected from the group which consists of [hipuromerosu], from claim 22 either of 28 in one sectionCoating lock of statement. 30. The binder which is soluble in the aforementioned water granulation liquid, 15 weight %, features that from 0.5 8 weight % it exists desirably at the quantity from 0 of gross weight of the aforementioned nucleus, in claim 29 the coating lock of statement. 31. The aforementioned lubricant: Stearic acid calcium, stearic acid magnesium, the zinc stearate, stearic acid, fumaric acid and the steering rill fumaric acid sodium, the [jibehen] acid glycerine, [jisutearin] guriseroru and dipalmitostearin acid [guriseriru], the [behenoiruporiokishiru] - 8 glyceride mineral oils and polyethylene glycol, it features that desirably it is selected from the group which consists of stearic acid magnesium, from claim 22 either of 30 in one section the coating lock of statement. 32. The aforementioned lubricant, 5 weight %, features that from 0.2 3 weight % it exists desirably at the quantity from 0 of gross weight of the aforementioned nucleus, in claim 31 the coating lock of statement. 33. The nucleus which includes below: The to o particulate [rehuamechinibu] which is the multiformity A which is converted;  And It is below the o and the nuclear *** shape medicine which is allowed pharmacy: - The dust diluent and the dry binder which are mannitol;   - The collapse medicine which is [kurosukarumerosunatoriumu];   - The surface active agent which is the lauryl sodium sulfate;   - The binder which is [hipuromerosu];   - The lubricant which is stearic acid magnesium;   And The polyethylene glycol which includes below the stability maintenance coating which is not included: o hydroxypropyl methyl cellulose ([hipuromerosu] (HPMC))So the stability maintenance film formation medicine which is;   To be possible the o furthermore the stability maintenance film formation medicine to include;   And, It is below the o and it is good including the coating *** shape medicine which is allowed pharmacy: - Iron oxide and/or the coloration charge which is titanium dioxide;   - The talc, the lecithin and/or the anti arrival medicine which is the soy bean lecithin;  And - The talc and/or the opacefier which is titanium dioxide It includes, from claim 1 from 7 or 13 either of 32 in one section the coating lock of statement. 34. The nucleus which includes below: The to o particulate [rehuamechinibu] which is the multiformity A which is converted;  And It is below the o and the nuclear *** shape medicine which is allowed pharmacy: - The dust diluent and the dry binder which are mannitol;   - The collapse medicine which is [kurosukarumerosunatoriumu];   - The surface active agent which is the lauryl sodium sulfate;   - The binder which is [hipuromerosu];   - The lubricant which is stearic acid magnesium;   And The stability maintenance coating which includes below: o poly- vinyl alcohol (PVA) the stability maintenance film formation medicine which is;   From 0 of o aforementioned stability maintenance coating 19 weight % the polyethylene glycol which is the quantity (PEG);   And, It is below the o and it is good including the coating *** shape medicine which is allowed pharmacy: - Iron oxide and/or the coloration charge which is titanium dioxide;   - The talc, the lecithin and/or the anti arrival medicine which is the soy bean lecithin;  And - The talc and/or the opacefier which is titanium dioxide It includes, from claim 8 either of 32 in one section the coating lock of statement. 35. The nucleus which includes below: The to o particulate [rehuamechinibu] which is the multiformity A which is converted;  And It is below the o and the nuclear *** shape medicine which is allowed pharmacy: - Being mannitol, from 0 of gross weight of the aforementioned nucleus 95 weight %, the dust diluent and the dry binder which from 30 80 weight % exist desirably at the quantity;   - [kurokarumerosunatoriumu] (crocarmellose sodium) being, from 0 of gross weight of the aforementioned nucleus 15 weight %, the collapse medicine which from 3 10 weight % is contained desirably at the quantity;   - Being the lauryl sodium sulfate, from 0.5 of gross weight of the aforementioned nucleus 1 weight %, the surface active agent which from 0.1 2 weight % exists desirably at the quantity;   - Being [hipuromerosu], from 0 of gross weight of the aforementioned nucleus 15 weight %, the binder which from 0.5 8 weight % exists desirably at the quantity;   - Being stearic acid magnesium, from 0 of gross weight of the aforementioned nucleus 5 weight %, the lubricant which from 0.2 3 weight % is contained desirably at the quantity;   And The polyethylene glycol which includes below the stability maintenance coating which is not included: The stability maintenance film formation medicine which is below the o: - The aforementioned polyethylene glycol from 30 of the stability maintenance coating which is not included 100 weight %, the hydroxypropyl methyl cellulose which from 40 55 weight % exists desirably at the quantity ([hipuromerosu] (HPMC));   And, It is below the o and it is good including the coating *** shape medicine which is allowed pharmacy: - Being iron oxide or titanium dioxide, the aforementioned polyethylene glycol from 10 of the stability maintenance coating which is not included 50 weight % the coloration charge which exists at the quantity;   - Being the talc, the aforementioned polyethylene glycol from 1 of the stability maintenance coating which is not included 40 weight %, the anti arrival medicine which from 3 25 weight % exists desirably at the quantity;  And - Being the talc and/or titanium dioxide, the aforementioned polyethylene glycol from 10 of the stability maintenance coating which is not included 60 weight % the opacefier which exists at the quantity It includes, from claim 1 from 7 or 13 either of 33 in one section the coating lock of statement. 36. The nucleus which includes below: The to o particulate [rehuamechinibu] which is the multiformity A which is converted;  And It is below the o and the nuclear *** shape medicine which is allowed pharmacy: - Being mannitol, from 0 of gross weight of the aforementioned nucleus 95 weight %, the dust diluent and the dry binder which from 30 80 weight % exist desirably at the quantity;   - [kurokarumerosunatoriumu] (crocarmellose sodium) being, from 0 of gross weight of the aforementioned nucleus 15 weight %, the collapse medicine which from 3 10 weight % is contained desirably at the quantity;   - Being the lauryl sodium sulfate, from 0.5 of gross weight of the aforementioned nucleus 1 weight %, the surface active agent which from 0.1 2 weight % exists desirably at the quantity;   - Being [hipuromerosu], from 0 of gross weight of the aforementioned nucleus 15 weight %, the binder which from 0.5 8 weight % exists desirably at the quantity;   - Being stearic acid magnesium, from 0 of gross weight of the aforementioned nucleus 5 weight %, the lubricant which from 0.2 3 weight % is contained desirably at the quantity;   And The stability maintenance coating which includes below: The stability maintenance film formation medicine which is below the o;   - From 30 of the aforementioned stability maintenance coating 100 weight %, the poly- vinyl alcohol which from 40 55 weight % exists desirably at the quantity (the part hydrolysate) (PVA);   - From 0 of the aforementioned stability maintenance coating 19 weight % the polyethylene glycol which exists at the quantity (PEG);   And, It is below the o and it is good including the coating *** shape medicine which is allowed pharmacy: - Being iron oxide or titanium dioxide, from 10 of the aforementioned stability maintenance coating 50 weight % the coloration charge which exists at the quantity;   - Being the talc, from 1 of the aforementioned stability maintenance coating 40 weight %, the anti arrival medicine which from 3 25 weight % exists desirably at the quantity;  And - Being the talc and/or titanium dioxide, from 10 of the aforementioned stability maintenance coating 60 weight % the opacefier which exists at the quantity It includes, from claim 8 either 32 or 34 in one section the coating lock of statement. 37. 10, 20 and 30 or [rehuamechinibu] of 50mg is contained, from claim 1 either of 36 in one section the coating lock of statement. 38. Step below is included, from claim 1 either of 37 the method of manufacturing the coating lock of statement in one section: a) Being granulation step: i) Inserting the aforementioned binder and the aforementioned penetrant in underwater, it melts, it supplies the granulation liquid this way;   II) The to particulate for example the aforementioned granulation liquid, as a powder bed multiform A [rehuamechinibu] which is converted, the aforementioned dust diluent/for example in the fluidized bed granulation inside of a plane, for example from 20 at temperature of the 35.deg.C and the like, desirably at temperature of the 34.deg.C, it applies to the blend of the dry binder and the aforementioned collapse medicine, from 28 for example by among other things spraying doing;   [rehuamechinibu] content granulation ones are supplied this way, granulation step;   b) Being making tablet step: i) Ideal size, for example it does to screen aforementioned granulation ones, to 0.8mm such as 1.0mm desirably from 0.5, [rehuamechinibu] content granulation ones which are screened in this way it supplies;   II) The description above [rehuamechinibu] content granulation ones which are screened are mixed with the aforementioned collapse medicine and the aforementioned lubricant, manufacturing end for making tablet (ready-to-press) [rehuamechinibu] content blend is supplied this way;   III) The aforementioned [rehuamechinibu] content blend, for example is compressed in tablet with such as rotary making tablet on board, 10, 20 and 30 or the tablet where the [rehuamechinibu] content which contains [rehuamechinibu] of 50mg is not covered is supplied for example this way, making tablet step;   c) Being film coating step: i) Making use of the aforementioned stability maintenance film formation medicine, the aforementioned anti arrival medicine and the aforementioned coloration charge, and the aforementioned plasticizer it is good, it makes underwater disperse, it supplies coating dispersed ones this way;   II) Aforementioned coating dispersed ones, for example inside and the like perforated [doramukota], for example from 35 at temperature of the 60.deg.C, desirably at temperature of the 55.deg.C, are applied to the tablet where the aforementioned [rehuamechinibu] content is not covered, from 40 for example by among other things spraying doing;   Either of 37 the coating lock of statement is supplied to one section from claim 1 this way, film coating step. 39. The disease, from claim 1 for using especially in the disposal or preventing of the cancer either of 37 in one section the coating lock of statement. 40. The disease, especially, from claim 1 for preventing or disposal the cancer either of 37 in one section use of the coating lock of statement. 41. The aforementioned disease, the liver cell cancer, the pancreas cancer and the colon rectum cancer, the non small cell lung cancer, is the non [hojikinrinpa] swelling and the milk cancer, in claim 39 or 40 use of statement. 42. From claim 1 either of 37 the coating lock of statement it depends on prescribing to the object which has the necessity in one section, the excessive vegetating disease of the mammal and/or, desirably the liver cell cancer such as blood vessel new life obstacle and for example the cancer, the pancreas cancer and the colon rectum cancer, the non small cell lung cancer, the non [hojikinrinpa] swelling and the method of dealing with the milk cancer. 43. 1 or the plural activators, for example the anti- excessive multiplication medicine or the cell poisonous medicine and the signal transmission inhibiter etc and, or the other carcinostatic substance or the remedy, or other adaptation medicine (indication agent) with, it combines with those mixture ones and combination in the same way, in claim 42 method of statement.
法律状态
(JP2016531151) LEGAL DETAILS FOR JP2016531151  Actual or expected expiration date=2034-09-11    Legal state=ALIVE    Status=PENDING     Event publication date=2014-09-11  Event code=JP/APP  Event indicator=Pos  Event type=Examination events  Application details  Application country=JP JP2016542319  Application date=2014-09-11  Standardized application number=2016JP-0542319     Event publication date=2016-10-06  Event code=JP/A  Event indicator=Pos  Event type=Examination events  Published application  Publication country=JP  Publication number=JP2016531151  Publication stage Code=A  Publication date=2016-10-06  Standardized publication number=JP2016531151
专利类型码
A
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