JP2016050206A - レボカルニチンを含有する医薬錠剤 - Google Patents
レボカルニチンを含有する医薬錠剤 Download PDFInfo
- Publication number
- JP2016050206A JP2016050206A JP2015168835A JP2015168835A JP2016050206A JP 2016050206 A JP2016050206 A JP 2016050206A JP 2015168835 A JP2015168835 A JP 2015168835A JP 2015168835 A JP2015168835 A JP 2015168835A JP 2016050206 A JP2016050206 A JP 2016050206A
- Authority
- JP
- Japan
- Prior art keywords
- weight
- tablet
- water
- levocarnitine
- additive
- 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.)
- Pending
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- PHIQHXFUZVPYII-ZCFIWIBFSA-N (R)-carnitine Chemical compound C[N+](C)(C)C[C@H](O)CC([O-])=O PHIQHXFUZVPYII-ZCFIWIBFSA-N 0.000 title claims abstract description 83
- 229960001518 levocarnitine Drugs 0.000 title claims abstract description 74
- 239000000654 additive Substances 0.000 claims abstract description 115
- 230000000996 additive effect Effects 0.000 claims abstract description 95
- 229920002678 cellulose Polymers 0.000 claims abstract description 57
- 239000001913 cellulose Substances 0.000 claims abstract description 57
- 235000010980 cellulose Nutrition 0.000 claims abstract description 57
- 229940031703 low substituted hydroxypropyl cellulose Drugs 0.000 claims abstract description 55
- 235000012239 silicon dioxide Nutrition 0.000 claims abstract description 40
- 229920002134 Carboxymethyl cellulose Polymers 0.000 claims abstract description 37
- 235000010948 carboxy methyl cellulose Nutrition 0.000 claims abstract description 37
- RMAQACBXLXPBSY-UHFFFAOYSA-N silicic acid Chemical compound O[Si](O)(O)O RMAQACBXLXPBSY-UHFFFAOYSA-N 0.000 claims abstract description 30
- VJHCJDRQFCCTHL-UHFFFAOYSA-N acetic acid 2,3,4,5,6-pentahydroxyhexanal Chemical compound CC(O)=O.OCC(O)C(O)C(O)C(O)C=O VJHCJDRQFCCTHL-UHFFFAOYSA-N 0.000 claims abstract description 25
- 229950008138 carmellose Drugs 0.000 claims abstract description 25
- 229920002472 Starch Polymers 0.000 claims abstract description 19
- 239000008107 starch Substances 0.000 claims abstract description 19
- 235000019698 starch Nutrition 0.000 claims abstract description 19
- 239000013557 residual solvent Substances 0.000 claims abstract description 11
- 229920002261 Corn starch Polymers 0.000 claims abstract description 10
- 125000002057 carboxymethyl group Chemical group [H]OC(=O)C([H])([H])[*] 0.000 claims abstract description 10
- 239000008120 corn starch Substances 0.000 claims abstract description 10
- 239000008187 granular material Substances 0.000 claims description 81
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 28
- 238000004519 manufacturing process Methods 0.000 claims description 27
- 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 claims description 24
- 238000002156 mixing Methods 0.000 claims description 24
- 239000011734 sodium Substances 0.000 claims description 19
- 229910052708 sodium Inorganic materials 0.000 claims description 19
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 claims description 12
- 239000011575 calcium Substances 0.000 claims description 12
- 229910052791 calcium Inorganic materials 0.000 claims description 12
- 239000001768 carboxy methyl cellulose Substances 0.000 claims description 12
- 239000008112 carboxymethyl-cellulose Substances 0.000 claims description 12
- 239000000377 silicon dioxide Substances 0.000 claims description 12
- 229920002785 Croscarmellose sodium Polymers 0.000 claims description 11
- 229960001681 croscarmellose sodium Drugs 0.000 claims description 11
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 claims description 11
- 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 claims description 10
- 239000011247 coating layer Substances 0.000 claims description 7
- 239000011248 coating agent Substances 0.000 abstract description 15
- 238000000576 coating method Methods 0.000 abstract description 13
- 239000012458 free base Substances 0.000 abstract 2
- 239000003826 tablet Substances 0.000 description 157
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 27
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 description 21
- 239000001863 hydroxypropyl cellulose Substances 0.000 description 21
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 description 21
- 229940071676 hydroxypropylcellulose Drugs 0.000 description 21
- 239000000203 mixture Substances 0.000 description 19
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 18
- 238000002360 preparation method Methods 0.000 description 14
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 13
- -1 carnitine ions Chemical class 0.000 description 12
- 238000000034 method Methods 0.000 description 12
- 238000003756 stirring Methods 0.000 description 12
- 238000005469 granulation Methods 0.000 description 10
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- 235000019359 magnesium stearate Nutrition 0.000 description 9
- 239000003795 chemical substances by application Substances 0.000 description 8
- 238000009472 formulation Methods 0.000 description 8
- 239000000314 lubricant Substances 0.000 description 8
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 7
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 7
- 238000006467 substitution reaction Methods 0.000 description 7
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 description 6
- 238000000502 dialysis Methods 0.000 description 6
- 239000007888 film coating Substances 0.000 description 6
- 238000009501 film coating Methods 0.000 description 6
- 239000007788 liquid Substances 0.000 description 6
- 239000000546 pharmaceutical excipient Substances 0.000 description 6
- 239000011230 binding agent Substances 0.000 description 5
- FUFJGUQYACFECW-UHFFFAOYSA-L calcium hydrogenphosphate Chemical compound [Ca+2].OP([O-])([O-])=O FUFJGUQYACFECW-UHFFFAOYSA-L 0.000 description 5
- 229960004203 carnitine Drugs 0.000 description 5
- 235000019700 dicalcium phosphate Nutrition 0.000 description 5
- 239000003814 drug Substances 0.000 description 5
- 230000000694 effects Effects 0.000 description 5
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 description 5
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 description 5
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 description 5
- 239000011259 mixed solution Substances 0.000 description 5
- 239000000047 product Substances 0.000 description 5
- 206010058892 Carnitine deficiency Diseases 0.000 description 4
- 229920001353 Dextrin Polymers 0.000 description 4
- 239000004375 Dextrin Substances 0.000 description 4
- 235000019425 dextrin Nutrition 0.000 description 4
- IDGUHHHQCWSQLU-UHFFFAOYSA-N ethanol;hydrate Chemical compound O.CCO IDGUHHHQCWSQLU-UHFFFAOYSA-N 0.000 description 4
- 239000012528 membrane Substances 0.000 description 4
- 239000003960 organic solvent Substances 0.000 description 4
- 229940069328 povidone Drugs 0.000 description 4
- 208000016505 systemic primary carnitine deficiency disease Diseases 0.000 description 4
- 239000000454 talc Substances 0.000 description 4
- 229910052623 talc Inorganic materials 0.000 description 4
- 238000010521 absorption reaction Methods 0.000 description 3
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- 229940079593 drug Drugs 0.000 description 3
- 238000001035 drying Methods 0.000 description 3
- 125000002887 hydroxy group Chemical group [H]O* 0.000 description 3
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 description 3
- 230000001771 impaired effect Effects 0.000 description 3
- 239000000825 pharmaceutical preparation Substances 0.000 description 3
- 239000001267 polyvinylpyrrolidone Substances 0.000 description 3
- 150000003839 salts Chemical class 0.000 description 3
- 239000007787 solid Substances 0.000 description 3
- 238000005507 spraying Methods 0.000 description 3
- 239000000126 substance Substances 0.000 description 3
- 238000010998 test method Methods 0.000 description 3
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 description 2
- VEXZGXHMUGYJMC-UHFFFAOYSA-M Chloride anion Chemical compound [Cl-] VEXZGXHMUGYJMC-UHFFFAOYSA-M 0.000 description 2
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 description 2
- UQSXHKLRYXJYBZ-UHFFFAOYSA-N Iron oxide Chemical compound [Fe]=O UQSXHKLRYXJYBZ-UHFFFAOYSA-N 0.000 description 2
- 239000002202 Polyethylene glycol Substances 0.000 description 2
- 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 2
- 229930006000 Sucrose Natural products 0.000 description 2
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 description 2
- YKTSYUJCYHOUJP-UHFFFAOYSA-N [O--].[Al+3].[Al+3].[O-][Si]([O-])([O-])[O-] Chemical compound [O--].[Al+3].[Al+3].[O-][Si]([O-])([O-])[O-] YKTSYUJCYHOUJP-UHFFFAOYSA-N 0.000 description 2
- CJZGTCYPCWQAJB-UHFFFAOYSA-L calcium stearate Chemical compound [Ca+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O CJZGTCYPCWQAJB-UHFFFAOYSA-L 0.000 description 2
- 235000013539 calcium stearate Nutrition 0.000 description 2
- 239000008116 calcium stearate Substances 0.000 description 2
- 125000003178 carboxy group Chemical group [H]OC(*)=O 0.000 description 2
- PHIQHXFUZVPYII-UHFFFAOYSA-N carnitine Chemical compound C[N+](C)(C)CC(O)CC([O-])=O PHIQHXFUZVPYII-UHFFFAOYSA-N 0.000 description 2
- 229960000678 carnitine chloride Drugs 0.000 description 2
- 239000003086 colorant Substances 0.000 description 2
- 150000001875 compounds Chemical class 0.000 description 2
- 229940099112 cornstarch Drugs 0.000 description 2
- 229960000913 crospovidone Drugs 0.000 description 2
- 235000014113 dietary fatty acids Nutrition 0.000 description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
- 239000002270 dispersing agent Substances 0.000 description 2
- MVPICKVDHDWCJQ-UHFFFAOYSA-N ethyl 3-pyrrolidin-1-ylpropanoate Chemical compound CCOC(=O)CCN1CCCC1 MVPICKVDHDWCJQ-UHFFFAOYSA-N 0.000 description 2
- 239000000194 fatty acid Substances 0.000 description 2
- 229930195729 fatty acid Natural products 0.000 description 2
- 239000007941 film coated tablet Substances 0.000 description 2
- 125000000524 functional group Chemical group 0.000 description 2
- 238000004817 gas chromatography Methods 0.000 description 2
- 229960003943 hypromellose Drugs 0.000 description 2
- JEIPFZHSYJVQDO-UHFFFAOYSA-N iron(III) oxide Inorganic materials O=[Fe]O[Fe]=O JEIPFZHSYJVQDO-UHFFFAOYSA-N 0.000 description 2
- YOBAEOGBNPPUQV-UHFFFAOYSA-N iron;trihydrate Chemical compound O.O.O.[Fe].[Fe] YOBAEOGBNPPUQV-UHFFFAOYSA-N 0.000 description 2
- 229960003511 macrogol Drugs 0.000 description 2
- 229920000609 methyl cellulose Polymers 0.000 description 2
- 239000001923 methylcellulose Substances 0.000 description 2
- 235000010981 methylcellulose Nutrition 0.000 description 2
- 239000002245 particle Substances 0.000 description 2
- 229940127557 pharmaceutical product Drugs 0.000 description 2
- 239000004014 plasticizer Substances 0.000 description 2
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- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 description 2
- 229940088417 precipitated calcium carbonate Drugs 0.000 description 2
- 229940045902 sodium stearyl fumarate Drugs 0.000 description 2
- 239000005720 sucrose Substances 0.000 description 2
- 239000004094 surface-active agent Substances 0.000 description 2
- OGIDPMRJRNCKJF-UHFFFAOYSA-N titanium oxide Inorganic materials [Ti]=O OGIDPMRJRNCKJF-UHFFFAOYSA-N 0.000 description 2
- LNAZSHAWQACDHT-XIYTZBAFSA-N (2r,3r,4s,5r,6s)-4,5-dimethoxy-2-(methoxymethyl)-3-[(2s,3r,4s,5r,6r)-3,4,5-trimethoxy-6-(methoxymethyl)oxan-2-yl]oxy-6-[(2r,3r,4s,5r,6r)-4,5,6-trimethoxy-2-(methoxymethyl)oxan-3-yl]oxyoxane Chemical compound CO[C@@H]1[C@@H](OC)[C@H](OC)[C@@H](COC)O[C@H]1O[C@H]1[C@H](OC)[C@@H](OC)[C@H](O[C@H]2[C@@H]([C@@H](OC)[C@H](OC)O[C@@H]2COC)OC)O[C@@H]1COC LNAZSHAWQACDHT-XIYTZBAFSA-N 0.000 description 1
- 208000010444 Acidosis Diseases 0.000 description 1
- PNEYBMLMFCGWSK-UHFFFAOYSA-N Alumina Chemical compound [O-2].[O-2].[O-2].[Al+3].[Al+3] PNEYBMLMFCGWSK-UHFFFAOYSA-N 0.000 description 1
- 101710147349 Carnitine transporter Proteins 0.000 description 1
- AUNGANRZJHBGPY-UHFFFAOYSA-N D-Lyxoflavin Natural products OCC(O)C(O)C(O)CN1C=2C=C(C)C(C)=CC=2N=C2C1=NC(=O)NC2=O AUNGANRZJHBGPY-UHFFFAOYSA-N 0.000 description 1
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- OENHQHLEOONYIE-UKMVMLAPSA-N all-trans beta-carotene Natural products CC=1CCCC(C)(C)C=1/C=C/C(/C)=C/C=C/C(/C)=C/C=C/C=C(C)C=CC=C(C)C=CC1=C(C)CCCC1(C)C OENHQHLEOONYIE-UKMVMLAPSA-N 0.000 description 1
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- TUPZEYHYWIEDIH-WAIFQNFQSA-N beta-carotene Natural products CC(=C/C=C/C=C(C)/C=C/C=C(C)/C=C/C1=C(C)CCCC1(C)C)C=CC=C(/C)C=CC2=CCCCC2(C)C TUPZEYHYWIEDIH-WAIFQNFQSA-N 0.000 description 1
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- HUSUHZRVLBSGBO-UHFFFAOYSA-L calcium;dihydrogen phosphate;hydroxide Chemical compound O.[Ca+2].OP([O-])([O-])=O HUSUHZRVLBSGBO-UHFFFAOYSA-L 0.000 description 1
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- WTFXARWRTYJXII-UHFFFAOYSA-N iron(2+);iron(3+);oxygen(2-) Chemical compound [O-2].[O-2].[O-2].[O-2].[Fe+2].[Fe+3].[Fe+3] WTFXARWRTYJXII-UHFFFAOYSA-N 0.000 description 1
- SZVJSHCCFOBDDC-UHFFFAOYSA-N iron(II,III) oxide Inorganic materials O=[Fe]O[Fe]O[Fe]=O SZVJSHCCFOBDDC-UHFFFAOYSA-N 0.000 description 1
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- ZLGIYFNHBLSMPS-ATJNOEHPSA-N shellac Chemical compound OCCCCCC(O)C(O)CCCCCCCC(O)=O.C1C23[C@H](C(O)=O)CCC2[C@](C)(CO)[C@@H]1C(C(O)=O)=C[C@@H]3O ZLGIYFNHBLSMPS-ATJNOEHPSA-N 0.000 description 1
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- VZCYOOQTPOCHFL-UHFFFAOYSA-N trans-butenedioic acid Natural products OC(=O)C=CC(O)=O VZCYOOQTPOCHFL-UHFFFAOYSA-N 0.000 description 1
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- 238000005550 wet granulation Methods 0.000 description 1
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- OENHQHLEOONYIE-JLTXGRSLSA-N β-Carotene Chemical compound CC=1CCCC(C)(C)C=1\C=C\C(\C)=C\C=C\C(\C)=C\C=C\C=C(/C)\C=C\C=C(/C)\C=C\C1=C(C)CCCC1(C)C OENHQHLEOONYIE-JLTXGRSLSA-N 0.000 description 1
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- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2015168835A JP2016050206A (ja) | 2014-08-29 | 2015-08-28 | レボカルニチンを含有する医薬錠剤 |
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2014176384 | 2014-08-29 | ||
| JP2014176384 | 2014-08-29 | ||
| JP2015168835A JP2016050206A (ja) | 2014-08-29 | 2015-08-28 | レボカルニチンを含有する医薬錠剤 |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2020096003A Division JP7005687B2 (ja) | 2014-08-29 | 2020-06-02 | レボカルニチンを含有する医薬錠剤 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| JP2016050206A true JP2016050206A (ja) | 2016-04-11 |
Family
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Family Applications (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2015168835A Pending JP2016050206A (ja) | 2014-08-29 | 2015-08-28 | レボカルニチンを含有する医薬錠剤 |
| JP2020096003A Active JP7005687B2 (ja) | 2014-08-29 | 2020-06-02 | レボカルニチンを含有する医薬錠剤 |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
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| JP2019094305A (ja) * | 2017-11-27 | 2019-06-20 | 株式会社古川リサーチオフィス | オロット酸−カルニチン混合体粉体又はフマル酸−カルニチン混合体粉体の製造方法 |
| JP2020176107A (ja) * | 2019-04-18 | 2020-10-29 | 共和薬品工業株式会社 | 吸湿性成分を含むコーティング錠 |
| JP2021001168A (ja) * | 2019-06-24 | 2021-01-07 | 大塚製薬株式会社 | レボカルニチン含有錠剤 |
| JP2021011461A (ja) * | 2019-07-09 | 2021-02-04 | 東和薬品株式会社 | レボカルニチンを含有する錠剤 |
| CN112826803A (zh) * | 2021-02-24 | 2021-05-25 | 东北制药集团沈阳第一制药有限公司 | 一种左卡尼汀片及其制备方法 |
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Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2019094305A (ja) * | 2017-11-27 | 2019-06-20 | 株式会社古川リサーチオフィス | オロット酸−カルニチン混合体粉体又はフマル酸−カルニチン混合体粉体の製造方法 |
| JP2020176107A (ja) * | 2019-04-18 | 2020-10-29 | 共和薬品工業株式会社 | 吸湿性成分を含むコーティング錠 |
| JP7541319B2 (ja) | 2019-04-18 | 2024-08-28 | 共和薬品工業株式会社 | 吸湿性成分を含むコーティング錠 |
| JP2021001168A (ja) * | 2019-06-24 | 2021-01-07 | 大塚製薬株式会社 | レボカルニチン含有錠剤 |
| JP7588973B2 (ja) | 2019-06-24 | 2024-11-25 | 大塚製薬株式会社 | レボカルニチン含有錠剤 |
| JP2021011461A (ja) * | 2019-07-09 | 2021-02-04 | 東和薬品株式会社 | レボカルニチンを含有する錠剤 |
| JP7366612B2 (ja) | 2019-07-09 | 2023-10-23 | 東和薬品株式会社 | レボカルニチンを含有する錠剤 |
| CN112826803A (zh) * | 2021-02-24 | 2021-05-25 | 东北制药集团沈阳第一制药有限公司 | 一种左卡尼汀片及其制备方法 |
| CN112826803B (zh) * | 2021-02-24 | 2024-01-19 | 东北制药集团沈阳第一制药有限公司 | 一种左卡尼汀片及其制备方法 |
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| JP2022033292A (ja) | 2022-02-28 |
| JP2020128429A (ja) | 2020-08-27 |
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