CN1208350A - 高含量泛西洛维片剂 - Google Patents
高含量泛西洛维片剂 Download PDFInfo
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- CN1208350A CN1208350A CN97191703A CN97191703A CN1208350A CN 1208350 A CN1208350 A CN 1208350A CN 97191703 A CN97191703 A CN 97191703A CN 97191703 A CN97191703 A CN 97191703A CN 1208350 A CN1208350 A CN 1208350A
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- CN
- China
- Prior art keywords
- tablet
- famciclovir
- weight
- content
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- 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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- 229960004396 famciclovir Drugs 0.000 title claims abstract description 26
- GGXKWVWZWMLJEH-UHFFFAOYSA-N famcyclovir Chemical compound N1=C(N)N=C2N(CCC(COC(=O)C)COC(C)=O)C=NC2=C1 GGXKWVWZWMLJEH-UHFFFAOYSA-N 0.000 title claims abstract description 26
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 10
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 10
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims description 5
- 239000001863 hydroxypropyl cellulose Substances 0.000 claims description 5
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims description 5
- 235000019359 magnesium stearate Nutrition 0.000 claims description 5
- 229940079832 sodium starch glycolate Drugs 0.000 claims description 5
- 229920003109 sodium starch glycolate Polymers 0.000 claims description 5
- 239000008109 sodium starch glycolate Substances 0.000 claims description 5
- 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 4
- 239000008101 lactose Substances 0.000 claims description 4
- 238000000034 method Methods 0.000 claims description 4
- 239000000203 mixture Substances 0.000 claims description 4
- 239000004480 active ingredient Substances 0.000 abstract 1
- 239000003826 tablet Substances 0.000 description 28
- 239000011248 coating agent Substances 0.000 description 4
- 238000000576 coating method Methods 0.000 description 4
- 229940071676 hydroxypropylcellulose Drugs 0.000 description 4
- JNTOCHDNEULJHD-UHFFFAOYSA-N Penciclovir Chemical compound N1C(N)=NC(=O)C2=C1N(CCC(CO)CO)C=N2 JNTOCHDNEULJHD-UHFFFAOYSA-N 0.000 description 3
- 239000008187 granular material Substances 0.000 description 3
- 229960001179 penciclovir Drugs 0.000 description 3
- 230000000840 anti-viral effect Effects 0.000 description 2
- 238000005056 compaction Methods 0.000 description 2
- 238000001035 drying Methods 0.000 description 2
- 238000002360 preparation method Methods 0.000 description 2
- 238000012216 screening Methods 0.000 description 2
- 239000007916 tablet composition Substances 0.000 description 2
- 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
- 241000701074 Human alphaherpesvirus 2 Species 0.000 description 1
- 241000701085 Human alphaherpesvirus 3 Species 0.000 description 1
- 241000701076 Macacine alphaherpesvirus 1 Species 0.000 description 1
- 229920000168 Microcrystalline cellulose Polymers 0.000 description 1
- 239000003513 alkali Substances 0.000 description 1
- 230000003602 anti-herpes Effects 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 239000007891 compressed tablet Substances 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 238000001647 drug administration Methods 0.000 description 1
- 229940126534 drug product Drugs 0.000 description 1
- 239000007888 film coating Substances 0.000 description 1
- 238000009501 film coating Methods 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 238000000227 grinding Methods 0.000 description 1
- 208000002672 hepatitis B Diseases 0.000 description 1
- 235000019813 microcrystalline cellulose Nutrition 0.000 description 1
- 239000008108 microcrystalline cellulose Substances 0.000 description 1
- 229940016286 microcrystalline cellulose Drugs 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 150000003839 salts Chemical class 0.000 description 1
- 239000012453 solvate Substances 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
- A61K31/52—Purines, e.g. adenine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
- A61P31/20—Antivirals for DNA viruses
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
- A61P31/20—Antivirals for DNA viruses
- A61P31/22—Antivirals for DNA viruses for herpes viruses
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Virology (AREA)
- Oncology (AREA)
- Communicable Diseases (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Molecular Biology (AREA)
- Biotechnology (AREA)
- Engineering & Computer Science (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
一种以泛西洛维为活性成分的片剂,在这种片剂中,泛西洛维的百分重量为85%或者更高。
Description
本发明涉及一种药物产品的新型制剂。
EP-A-182024(Beecham Group p.l.c.)的实施例2披露了一种制备泛西洛维(famciclovir，一种可口服化合物)和喷西洛维的方法，喷西洛维具有抗疱疹病毒(如Ⅰ型单纯疱疹病毒、Ⅱ型单纯疱疹病毒和水痘带状疱疹病毒)感染，以及抗乙型肝炎病毒的抗病毒活性。喷西洛维及其抗病毒活性公开在于1986年9月7-13日在英国曼彻斯特召开的第十四届国际微生物学会议摘要(Abstracts of 14th Int.Congress of Microbiology)的摘要P.V11-5的193页中(Boyd等人)。
泛西洛维优选以含125mg、250mg、500mg或750mg活性成分的片剂形式给药。在片剂组合物中常见的是在片剂中包含赋形剂，如乳糖、淀粉羟基乙酸钠和硬脂酸镁，以使赋形剂总量至少为15％。无水乳糖通常包括在内，作为一种主要赋形剂以补偿在活性成分的压制特性中任何潜在的不稳定性。
赋形剂含量的百分数越高，则任何给定剂量的片剂尺寸越大。特别是在片剂含500mg和750mg活性成分的情况下，这种大尺寸片剂会影响病人的配合性，因为这种片剂的椭圆面将分别为18mm×8.5mm和21mm×10mm，此时片剂中含有大约76％的泛西洛维。
目前我们发现有可能将泛西洛维配制成含少于15％赋形剂的片剂，并且已证明泛西洛维的压制特性足够稳定，允许这种片剂存在。
因此，本发明提供了一种以泛西洛维为主要成分，并且泛西洛维的百分重量为85％或者更高的药物片剂。
除非另外说明，本文中所有的百分重量值都是根据可包衣(例如膜包衣)的任一种片剂芯定义的。
合适的片剂包含少于15％，少于10％，少于5％，优选0％的无水乳糖或者其它类似的赋形剂如微晶纤维素。
合适的片剂含泛西洛维的百分重量大于85％、86％、87％、88％、89％、90％或91％。优选泛西洛维的量为最高可能的百分含量。泛西洛维可以是任意合适的药物上可接受的形式，如以盐、溶剂化物或多晶型物的形式存在。优选泛西洛维呈无水的游离碱状态。
片剂组合物中包含的常见赋形剂包括羟丙基纤维素，例如最高到5％或3％，淀粉羟基乙酸钠，例如最高含量到15％、10％、7％或5％，以及硬脂酸镁，例如最高含量到2％或1％。
在这种片剂上，可以包覆用于片剂药物中的任意合适的包衣。
这种片剂是用本领域已知的常用压片方法制备的。在优选的方法中，泛西洛维与一种赋形剂如羟丙基纤维素一起制粒，目的是为了最小化活性成分物理形式变化的影响。这种颗粒经筛选和干燥后，与另一种任意的赋形剂混合，形成一种压制混合物。将片剂压制到适合所需剂量的尺寸和重量，然后可以按需要，任选包覆。
下列实施例举例说明了本发明。
实施例
括号中的百分数值是泛西洛维片剂中的百分数值，这种泛西洛维片剂目前已在大不列颠及北爱尔兰联合王国、美国和世界上其它国家的药品管理局注册。
组分 ％重量/重量 ％重量/重量
泛西洛维 91.42 (75.66)
羟基丙基纤维素 2.83 (2.34)
淀粉羟基乙酸钠 5.00 (5.00)
硬脂酸镁 0.75 (0.75)
无水乳糖 0 (16.25)
对于500mg的剂量，芯重大约547mg；对于750mg的剂量，芯重大约820mg。
对于包衣片剂，通过包衣添加2.5％的芯重。对于500mg剂量，该包覆片剂重量为560mg；对于750mg剂量，该包覆片剂重量为840mg。
这种片剂的制备是通过干混泛西洛维和羟丙基纤维素，然后在高剪切制粒机中用水使该混合物成粒状。将该湿物质筛选、干燥和研磨。然后将该研磨后的颗粒与淀粉羟基乙酸钠和硬脂酸镁混合以制造压制混合物。压制片剂到片剂所需强度的合适尺寸和重量，然后用水性膜包覆该片剂。
得到750mg片剂的椭圆形表面大小为19mm×9mm；500mg片剂的椭圆表面大小为17mm×8mm。
Claims (7)
1．一种药物片剂，其中活性成分为泛西洛维，并且泛西洛维在该片剂中的百分重量为85％或者更高。
2．根据权利要求1的一种药物片剂，其包含少于15％的乳糖。
3．根据权利要求1或2的一种药物片剂，其包含少于5％的乳糖。
4．根据权利要求1、2或3的一种药物片剂，其包含0％的乳糖。
5．根据权利要求1、2、3或4的一种药物片剂，其中该片剂中泛西洛维的百分重量是90％或者更高。
6．根据权利要求1至5中任一项的一种药物片剂，具有下述组成：
组分 ％重量/重量
泛西洛维 91.42
羟丙基纤维素 2.83
淀粉羟基乙酸钠 5.00
硬脂酸镁 0.75
无水乳糖 0
7．一种制备根据权利要求1至6中任一项的片剂的方法，其中将泛西洛维和赋形剂制成颗粒状，然后压制成片剂。
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GBGB9600847.9A GB9600847D0 (en) | 1996-01-16 | 1996-01-16 | Pharmaceuticals |
| GB9600847.9 | 1996-01-16 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1208350A true CN1208350A (zh) | 1999-02-17 |
| CN1132582C CN1132582C (zh) | 2003-12-31 |
Family
ID=10787105
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN97191703A Expired - Lifetime CN1132582C (zh) | 1996-01-16 | 1997-01-13 | 高含量泛西洛维片剂 |
Country Status (38)
| Country | Link |
|---|---|
| US (1) | US6765007B1 (zh) |
| EP (1) | EP0874632B1 (zh) |
| JP (2) | JP4711360B2 (zh) |
| KR (1) | KR100338829B1 (zh) |
| CN (1) | CN1132582C (zh) |
| AP (2) | AP747A (zh) |
| AR (1) | AR005456A1 (zh) |
| AT (1) | ATE220910T1 (zh) |
| AU (1) | AU713090B2 (zh) |
| BG (1) | BG63488B1 (zh) |
| BR (1) | BR9706982A (zh) |
| CY (1) | CY2390B1 (zh) |
| CZ (1) | CZ287205B6 (zh) |
| DE (1) | DE69714215T2 (zh) |
| DK (1) | DK0874632T3 (zh) |
| DZ (1) | DZ2159A1 (zh) |
| EA (1) | EA001946B1 (zh) |
| EG (1) | EG23684A (zh) |
| ES (1) | ES2180922T3 (zh) |
| GB (1) | GB9600847D0 (zh) |
| HK (1) | HK1016473A1 (zh) |
| HU (1) | HU225472B1 (zh) |
| IL (1) | IL124913A0 (zh) |
| MX (1) | MX9805713A (zh) |
| MY (1) | MY127527A (zh) |
| NO (1) | NO315689B1 (zh) |
| NZ (1) | NZ326769A (zh) |
| OA (1) | OA10812A (zh) |
| PE (1) | PE35498A1 (zh) |
| PL (1) | PL187291B1 (zh) |
| PT (1) | PT874632E (zh) |
| SK (1) | SK282132B6 (zh) |
| TR (1) | TR199800954T2 (zh) |
| TW (1) | TW434016B (zh) |
| UA (1) | UA63897C2 (zh) |
| UY (2) | UY24437A1 (zh) |
| WO (1) | WO1997025990A1 (zh) |
| ZA (1) | ZA97310B (zh) |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20100136106A1 (en) * | 2005-06-08 | 2010-06-03 | Gary Liversidge | Modified Release Famciclovir Compositions |
| KR101710148B1 (ko) | 2009-06-26 | 2017-02-27 | 타리스 바이오메디컬 엘엘씨 | 이식가능한 약물전달 디바이스에 사용되기 위한 고체 약물 정제 |
| JP2015063521A (ja) * | 2013-09-02 | 2015-04-09 | 科研製薬株式会社 | 高い薬物含有率を有する錠剤及びその製造方法 |
| CN104434852B (zh) * | 2013-09-18 | 2018-11-20 | 北京韩美药品有限公司 | 泛昔洛韦直压片及其制备方法 |
| CN112587491B (zh) * | 2021-01-03 | 2022-08-23 | 迪沙药业集团有限公司 | 一种泛昔洛韦片组合物 |
Family Cites Families (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE3421800C1 (de) * | 1984-06-12 | 1986-04-17 | Maschinen und Werkzeugbau Michael Brümmer GmbH, 8804 Dinkelsbühl | Elastische Walze zum Behandeln einer thermoplastischen Folie |
| DE3582399D1 (de) * | 1984-09-20 | 1991-05-08 | Beecham Group Plc | Purin-derivate und ihre pharmazeutische verwendung. |
| DE69207656T2 (de) * | 1991-01-30 | 1996-10-17 | Wellcome Found | Wasserlösliche tabletten |
| EP0586523A4 (en) | 1991-05-15 | 1995-11-29 | Univ Yale | Determination of prodrugs metabolizable by the liver and therapeutic use thereof |
| GB9303157D0 (en) * | 1993-02-17 | 1993-03-31 | Scotia Holdings Plc | Treatment of a group of related disorders |
| IL111138A (en) | 1993-10-05 | 1997-04-15 | Smithkline Beecham Plc | Pharmaceutical compositions comprising penciclovir and/or its bioprecursor and/or its derivatives for the treatment and prophylaxis of post-herpetic neuralgia |
| JP3702594B2 (ja) * | 1997-08-07 | 2005-10-05 | 株式会社明電舎 | パラメータ調節方法及び装置 |
-
1996
- 1996-01-16 GB GBGB9600847.9A patent/GB9600847D0/en active Pending
-
1997
- 1997-01-02 AP APAP/P/1997/000911A patent/AP747A/en active
- 1997-01-10 UY UY24437A patent/UY24437A1/es not_active IP Right Cessation
- 1997-01-13 EP EP97901539A patent/EP0874632B1/en not_active Expired - Lifetime
- 1997-01-13 HU HU9901021A patent/HU225472B1/hu unknown
- 1997-01-13 WO PCT/EP1997/000195 patent/WO1997025990A1/en active IP Right Grant
- 1997-01-13 DK DK97901539T patent/DK0874632T3/da active
- 1997-01-13 AU AU15418/97A patent/AU713090B2/en not_active Expired
- 1997-01-13 PT PT97901539T patent/PT874632E/pt unknown
- 1997-01-13 IL IL12491397A patent/IL124913A0/xx not_active IP Right Cessation
- 1997-01-13 AT AT97901539T patent/ATE220910T1/de active
- 1997-01-13 ES ES97901539T patent/ES2180922T3/es not_active Expired - Lifetime
- 1997-01-13 US US09/101,926 patent/US6765007B1/en not_active Expired - Lifetime
- 1997-01-13 CN CN97191703A patent/CN1132582C/zh not_active Expired - Lifetime
- 1997-01-13 CZ CZ19982254A patent/CZ287205B6/cs not_active IP Right Cessation
- 1997-01-13 EA EA199800573A patent/EA001946B1/ru not_active IP Right Cessation
- 1997-01-13 TR TR1998/00954T patent/TR199800954T2/xx unknown
- 1997-01-13 JP JP52569297A patent/JP4711360B2/ja not_active Expired - Lifetime
- 1997-01-13 NZ NZ326769A patent/NZ326769A/xx not_active IP Right Cessation
- 1997-01-13 UA UA98063199A patent/UA63897C2/uk unknown
- 1997-01-13 BR BR9706982A patent/BR9706982A/pt not_active IP Right Cessation
- 1997-01-13 AP APAP/P/1998/001298A patent/AP1114A/en active
- 1997-01-13 DE DE69714215T patent/DE69714215T2/de not_active Expired - Lifetime
- 1997-01-13 SK SK956-98A patent/SK282132B6/sk not_active IP Right Cessation
- 1997-01-13 PL PL97327922A patent/PL187291B1/pl unknown
- 1997-01-13 KR KR1019980705371A patent/KR100338829B1/ko not_active IP Right Cessation
- 1997-01-14 AR ARP970100130A patent/AR005456A1/es active IP Right Grant
- 1997-01-14 TW TW086100335A patent/TW434016B/zh not_active IP Right Cessation
- 1997-01-14 EG EG4697A patent/EG23684A/xx active
- 1997-01-15 DZ DZ970004A patent/DZ2159A1/fr active
- 1997-01-15 MY MYPI97000137A patent/MY127527A/en unknown
- 1997-01-15 ZA ZA9700310A patent/ZA97310B/xx unknown
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- 1997-05-16 UY UY24556A patent/UY24556A1/es not_active IP Right Cessation
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1998
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- 1998-07-15 BG BG102638A patent/BG63488B1/bg unknown
- 1998-07-15 NO NO19983259A patent/NO315689B1/no not_active IP Right Cessation
- 1998-07-16 OA OA9800116A patent/OA10812A/en unknown
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1999
- 1999-04-08 HK HK99101423A patent/HK1016473A1/xx not_active IP Right Cessation
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2003
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2008
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