CN102266303A - Capecitabine medicinal composition and preparation method thereof - Google Patents
Capecitabine medicinal composition and preparation method thereof Download PDFInfo
- Publication number
- CN102266303A CN102266303A CN 201110189145 CN201110189145A CN102266303A CN 102266303 A CN102266303 A CN 102266303A CN 201110189145 CN201110189145 CN 201110189145 CN 201110189145 A CN201110189145 A CN 201110189145A CN 102266303 A CN102266303 A CN 102266303A
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- China
- Prior art keywords
- capecitabine
- parts
- preparation
- present
- tablet
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- GAGWJHPBXLXJQN-UORFTKCHSA-N Capecitabine Chemical compound C1=C(F)C(NC(=O)OCCCCC)=NC(=O)N1[C@H]1[C@H](O)[C@H](O)[C@@H](C)O1 GAGWJHPBXLXJQN-UORFTKCHSA-N 0.000 title claims abstract description 17
- GAGWJHPBXLXJQN-UHFFFAOYSA-N Capecitabine Natural products C1=C(F)C(NC(=O)OCCCCC)=NC(=O)N1C1C(O)C(O)C(C)O1 GAGWJHPBXLXJQN-UHFFFAOYSA-N 0.000 title claims abstract description 16
- 229960004117 capecitabine Drugs 0.000 title claims abstract description 16
- 238000002360 preparation method Methods 0.000 title claims description 6
- 239000000203 mixture Substances 0.000 title description 2
- 238000000034 method Methods 0.000 claims description 8
- 238000007908 dry granulation Methods 0.000 claims description 3
- 238000001035 drying Methods 0.000 claims description 3
- 239000007888 film coating Substances 0.000 claims description 3
- 238000009501 film coating Methods 0.000 claims description 3
- 238000005507 spraying Methods 0.000 claims description 3
- 238000005550 wet granulation Methods 0.000 claims description 3
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 abstract 2
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 abstract 2
- 229920002785 Croscarmellose sodium Polymers 0.000 abstract 1
- 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 abstract 1
- 229920000168 Microcrystalline cellulose Polymers 0.000 abstract 1
- 239000001767 crosslinked sodium carboxy methyl cellulose Substances 0.000 abstract 1
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 abstract 1
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 abstract 1
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 abstract 1
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 abstract 1
- 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 abstract 1
- 239000008101 lactose Substances 0.000 abstract 1
- 235000019359 magnesium stearate Nutrition 0.000 abstract 1
- 235000019813 microcrystalline cellulose Nutrition 0.000 abstract 1
- 239000008108 microcrystalline cellulose Substances 0.000 abstract 1
- 229940016286 microcrystalline cellulose Drugs 0.000 abstract 1
- 239000008213 purified water Substances 0.000 abstract 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 abstract 1
- 239000003814 drug Substances 0.000 description 3
- 229940079593 drug Drugs 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 239000002994 raw material Substances 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- UHDGCWIWMRVCDJ-UHFFFAOYSA-N 1-beta-D-Xylofuranosyl-NH-Cytosine Natural products O=C1N=C(N)C=CN1C1C(O)C(O)C(CO)O1 UHDGCWIWMRVCDJ-UHFFFAOYSA-N 0.000 description 1
- 206010055113 Breast cancer metastatic Diseases 0.000 description 1
- 206010052358 Colorectal cancer metastatic Diseases 0.000 description 1
- UHDGCWIWMRVCDJ-PSQAKQOGSA-N Cytidine Natural products O=C1N=C(N)C=CN1[C@@H]1[C@@H](O)[C@@H](O)[C@H](CO)O1 UHDGCWIWMRVCDJ-PSQAKQOGSA-N 0.000 description 1
- 206010027336 Menstruation delayed Diseases 0.000 description 1
- 229930012538 Paclitaxel Natural products 0.000 description 1
- CZPWVGJYEJSRLH-UHFFFAOYSA-N Pyrimidine Chemical compound C1=CN=CN=C1 CZPWVGJYEJSRLH-UHFFFAOYSA-N 0.000 description 1
- 239000000654 additive Substances 0.000 description 1
- 230000000996 additive effect Effects 0.000 description 1
- -1 amoxy Chemical group 0.000 description 1
- 150000001454 anthracenes Chemical class 0.000 description 1
- 125000002915 carbonyl group Chemical group [*:2]C([*:1])=O 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 238000002512 chemotherapy Methods 0.000 description 1
- UHDGCWIWMRVCDJ-ZAKLUEHWSA-N cytidine Chemical compound O=C1N=C(N)C=CN1[C@H]1[C@H](O)[C@@H](O)[C@H](CO)O1 UHDGCWIWMRVCDJ-ZAKLUEHWSA-N 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 229910052731 fluorine Inorganic materials 0.000 description 1
- 239000011737 fluorine Substances 0.000 description 1
- 229960001592 paclitaxel Drugs 0.000 description 1
- 239000008194 pharmaceutical composition Substances 0.000 description 1
- 239000000651 prodrug Substances 0.000 description 1
- 229940002612 prodrug Drugs 0.000 description 1
- RCINICONZNJXQF-MZXODVADSA-N taxol Chemical compound O([C@@H]1[C@@]2(C[C@@H](C(C)=C(C2(C)C)[C@H](C([C@]2(C)[C@@H](O)C[C@H]3OC[C@]3([C@H]21)OC(C)=O)=O)OC(=O)C)OC(=O)[C@H](O)[C@@H](NC(=O)C=1C=CC=CC=1)C=1C=CC=CC=1)O)C(=O)C1=CC=CC=C1 RCINICONZNJXQF-MZXODVADSA-N 0.000 description 1
- 229940053867 xeloda Drugs 0.000 description 1
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention discloses capecitabine tablets, which comprise the following components in part by weight: 100 to 600 parts of capecitabine, 10 to 80 parts of microcrystalline cellulose, 10 to 70 parts of lactose, 30 to 100 parts of cross-linked sodium carboxymethylcellulose, 10 to 70 parts of 1 percent hydroxypropyl methylcellulose 50 percent ethanol solution, 1 to 10 percent of magnesium stearate and a proper amount of purified water.
Description
Technical field
The present invention relates to a kind of capecitabine sheet and preparation method thereof.
Background technology
Capecitabine, English name are Capecitabine, chemical name: 5 '-deoxidation-5-fluoro-N-[(amoxy) carbonyl] cytidine, commodity are called xeloda, molecular formula: C
15H
22O
6N
3F, its chemical structural formula is as follows:
Capecitabine is a kind of novel 5-fluorine pyrimidine (5-FU) prodrug by the development of Switzerland Roche Holding Ag.In JIUYUE, 1998 obtains drugs approved by FDA and is used for the treatment of the late period constitutional or the further treatment of metastatic breast cancer invalid to anthracene nucleus medicament chemotherapy such as paclitaxel and doxorubicins, and go on the market at Japan registration with identical indication in April, 2003.Calendar year 2001 FDA ratifies the treatment that capecitabine is used for metastatic colorectal cancer again.
Summary of the invention
At the deficiencies in the prior art, one of purpose of the present invention is to provide the capecitabine tablet, and described tablet consists of by weight:
Two of purpose of the present invention is to provide a kind of preparation method of capecitabine tablet, and described method comprises: super dry granulation or wet granulation, fluidized bed with spraying drying, the film coating pulverized.
The capecitabine additive of tablet and the principal agent compatibility that the present invention is prepared are good, and effect of drugs is good.
Description of drawings
Fig. 1 is preparation technology's flow chart of capecitabine tablet.
The specific embodiment
Embodiment one
Get the raw materials ready by following weight portion composition:
Surpass and pulverize dry granulation or wet granulation, the fluidized bed with spraying drying, film coating finally makes capecitabine tablet of the present invention.
Applicant's statement, the present invention illustrates detailed process equipment of the present invention and technological process by the foregoing description, but the present invention is not limited to above-mentioned detailed process equipment and technological process, does not mean that promptly the present invention must rely on above-mentioned detailed process equipment and technological process could be implemented.The person of ordinary skill in the field should understand, any improvement in the present invention to the interpolation of the equivalence replacement of each raw material of product of the present invention and auxiliary element, the selection of concrete mode etc., all drops within protection scope of the present invention and the open scope.
Claims (2)
1. capecitabine tablet, described tablet consists of by weight:
2. the preparation method of the described capecitabine tablet of claim 1, described method comprises: super dry granulation or wet granulation, fluidized bed with spraying drying, the film coating pulverized.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 201110189145 CN102266303A (en) | 2011-07-07 | 2011-07-07 | Capecitabine medicinal composition and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 201110189145 CN102266303A (en) | 2011-07-07 | 2011-07-07 | Capecitabine medicinal composition and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN102266303A true CN102266303A (en) | 2011-12-07 |
Family
ID=45048889
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 201110189145 Pending CN102266303A (en) | 2011-07-07 | 2011-07-07 | Capecitabine medicinal composition and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN102266303A (en) |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103251569A (en) * | 2013-05-30 | 2013-08-21 | 成都苑东药业有限公司 | Capecitabine tablet composition and preparation method thereof |
| CN103830259A (en) * | 2012-11-21 | 2014-06-04 | 苏州鑫贝瑞药业有限公司 | Capecitabine pharmaceutical composition, and preparation method thereof |
| CN104997744A (en) * | 2015-08-04 | 2015-10-28 | 孙丽华 | High-stability capecitabine tablets and preparation method thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5472949A (en) * | 1992-12-18 | 1995-12-05 | Hoffmann-La Roche Inc. | N4 -(substituted-oxycarbonyl)-5'-deoxy-5-fluorocytidine compounds, compositions and methods of using same |
| CN101522168A (en) * | 2006-10-06 | 2009-09-02 | 霍夫曼-拉罗奇有限公司 | Capecitabine pediatric tablets |
| US20110027374A1 (en) * | 2008-12-16 | 2011-02-03 | Maria Oksana Bachynsky | Capecitabine rapidly disintegrating tablets |
-
2011
- 2011-07-07 CN CN 201110189145 patent/CN102266303A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5472949A (en) * | 1992-12-18 | 1995-12-05 | Hoffmann-La Roche Inc. | N4 -(substituted-oxycarbonyl)-5'-deoxy-5-fluorocytidine compounds, compositions and methods of using same |
| CN101522168A (en) * | 2006-10-06 | 2009-09-02 | 霍夫曼-拉罗奇有限公司 | Capecitabine pediatric tablets |
| US20110027374A1 (en) * | 2008-12-16 | 2011-02-03 | Maria Oksana Bachynsky | Capecitabine rapidly disintegrating tablets |
Non-Patent Citations (1)
| Title |
|---|
| 《美国FDA药品数据库》 20110209 处方药说明书 Full prescribing information for XELODA(capecitabine) tablets, film coated for oral use 第20页第11Description节 1-2 , * |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103830259A (en) * | 2012-11-21 | 2014-06-04 | 苏州鑫贝瑞药业有限公司 | Capecitabine pharmaceutical composition, and preparation method thereof |
| CN103251569A (en) * | 2013-05-30 | 2013-08-21 | 成都苑东药业有限公司 | Capecitabine tablet composition and preparation method thereof |
| CN103251569B (en) * | 2013-05-30 | 2015-10-28 | 成都苑东药业有限公司 | Capecitabine tablet composition and preparation method thereof |
| CN104997744A (en) * | 2015-08-04 | 2015-10-28 | 孙丽华 | High-stability capecitabine tablets and preparation method thereof |
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| C10 | Entry into substantive examination | ||
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| ASS | Succession or assignment of patent right |
Owner name: HUABEI PHARMACEUTICAL CO., LTD. Free format text: FORMER OWNER: CHENG XUEXIANG Effective date: 20121211 |
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| C41 | Transfer of patent application or patent right or utility model | ||
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Free format text: CORRECT: ADDRESS; FROM: 100101 CHAOYANG, BEIJING TO: 050015 SHIJIAZHUANG, HEBEI PROVINCE |
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| TA01 | Transfer of patent application right |
Effective date of registration: 20121211 Address after: 050015 Heping East Road, Hebei, Shijiazhuang, No. 388 Applicant after: Huabei Pharmaceutical Co., Ltd. Address before: 100101 Beijing city Chaoyang District Xiaoying Road No. 13 Building Room 9008 in Asia and Africa Applicant before: Cheng Xuexiang |
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| C12 | Rejection of a patent application after its publication | ||
| RJ01 | Rejection of invention patent application after publication |
Application publication date: 20111207 |