CN116966157B - Theophylline sustained release tablet and preparation method thereof - Google Patents
Theophylline sustained release tablet and preparation method thereof Download PDFInfo
- Publication number
- CN116966157B CN116966157B CN202311226686.1A CN202311226686A CN116966157B CN 116966157 B CN116966157 B CN 116966157B CN 202311226686 A CN202311226686 A CN 202311226686A CN 116966157 B CN116966157 B CN 116966157B
- Authority
- CN
- China
- Prior art keywords
- parts
- theophylline
- release tablet
- preparation
- sustained
- 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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- ZFXYFBGIUFBOJW-UHFFFAOYSA-N theophylline Chemical compound O=C1N(C)C(=O)N(C)C2=C1NC=N2 ZFXYFBGIUFBOJW-UHFFFAOYSA-N 0.000 title claims abstract description 142
- 229960000278 theophylline Drugs 0.000 title claims abstract description 71
- 238000002360 preparation method Methods 0.000 title claims abstract description 40
- 239000007939 sustained release tablet Substances 0.000 title claims abstract description 39
- 239000001856 Ethyl cellulose Substances 0.000 claims abstract description 21
- 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 abstract description 21
- 235000019325 ethyl cellulose Nutrition 0.000 claims abstract description 21
- 229920001249 ethyl cellulose Polymers 0.000 claims abstract description 21
- 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 claims abstract description 19
- 229960004977 anhydrous lactose Drugs 0.000 claims abstract description 19
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 claims abstract description 17
- 239000011575 calcium Substances 0.000 claims abstract description 17
- 229910052791 calcium Inorganic materials 0.000 claims abstract description 17
- 239000000463 material Substances 0.000 claims abstract description 16
- 239000002994 raw material Substances 0.000 claims abstract description 15
- 239000000203 mixture Substances 0.000 claims abstract description 13
- 239000000853 adhesive Substances 0.000 claims abstract description 11
- 230000001070 adhesive effect Effects 0.000 claims abstract description 11
- 239000000945 filler Substances 0.000 claims abstract description 11
- 239000000314 lubricant Substances 0.000 claims abstract description 8
- 239000000080 wetting agent Substances 0.000 claims abstract description 5
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical group CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 53
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical group [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 34
- 238000002156 mixing Methods 0.000 claims description 28
- 238000001035 drying Methods 0.000 claims description 19
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims description 18
- 239000001863 hydroxypropyl cellulose Substances 0.000 claims description 17
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims description 17
- 235000019359 magnesium stearate Nutrition 0.000 claims description 17
- 239000007779 soft material Substances 0.000 claims description 15
- 239000008187 granular material Substances 0.000 claims description 12
- 239000002245 particle Substances 0.000 claims description 12
- 239000003826 tablet Substances 0.000 claims description 12
- 238000013268 sustained release Methods 0.000 claims description 7
- 239000012730 sustained-release form Substances 0.000 claims description 6
- FUFJGUQYACFECW-UHFFFAOYSA-L calcium hydrogenphosphate Chemical compound [Ca+2].OP([O-])([O-])=O FUFJGUQYACFECW-UHFFFAOYSA-L 0.000 claims description 5
- 229920003156 Eudragit® RL PO Polymers 0.000 claims 2
- 235000019700 dicalcium phosphate Nutrition 0.000 claims 2
- 238000000034 method Methods 0.000 abstract description 15
- 238000004519 manufacturing process Methods 0.000 abstract description 3
- 239000000825 pharmaceutical preparation Substances 0.000 abstract description 2
- 239000003814 drug Substances 0.000 description 17
- 229920003134 Eudragit® polymer Polymers 0.000 description 13
- VVQNEPGJFQJSBK-UHFFFAOYSA-N Methyl methacrylate Chemical compound COC(=O)C(C)=C VVQNEPGJFQJSBK-UHFFFAOYSA-N 0.000 description 13
- 238000012360 testing method Methods 0.000 description 13
- 239000008280 blood Substances 0.000 description 12
- 210000004369 blood Anatomy 0.000 description 12
- 229940079593 drug Drugs 0.000 description 12
- 239000003405 delayed action preparation Substances 0.000 description 11
- 235000019441 ethanol Nutrition 0.000 description 9
- 230000000052 comparative effect Effects 0.000 description 6
- 230000000694 effects Effects 0.000 description 6
- 239000007788 liquid Substances 0.000 description 6
- 230000000291 postprandial effect Effects 0.000 description 6
- 238000005550 wet granulation Methods 0.000 description 6
- 238000004090 dissolution Methods 0.000 description 5
- 239000003153 chemical reaction reagent Substances 0.000 description 4
- 230000001276 controlling effect Effects 0.000 description 4
- 230000001225 therapeutic effect Effects 0.000 description 4
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 description 3
- 239000002552 dosage form Substances 0.000 description 3
- 239000000523 sample Substances 0.000 description 3
- 239000000243 solution Substances 0.000 description 3
- 230000002459 sustained effect Effects 0.000 description 3
- 206010067484 Adverse reaction Diseases 0.000 description 2
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Chemical compound 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 description 2
- 230000006838 adverse reaction Effects 0.000 description 2
- FQPFAHBPWDRTLU-UHFFFAOYSA-N aminophylline Chemical compound NCCN.O=C1N(C)C(=O)N(C)C2=C1NC=N2.O=C1N(C)C(=O)N(C)C2=C1NC=N2 FQPFAHBPWDRTLU-UHFFFAOYSA-N 0.000 description 2
- 208000006673 asthma Diseases 0.000 description 2
- 239000003795 chemical substances by application Substances 0.000 description 2
- 239000012738 dissolution medium Substances 0.000 description 2
- 238000009472 formulation Methods 0.000 description 2
- 239000002609 medium Substances 0.000 description 2
- 239000000843 powder Substances 0.000 description 2
- 239000008213 purified water Substances 0.000 description 2
- 230000001105 regulatory effect Effects 0.000 description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 2
- KMEBCRWKZZSRRT-UHFFFAOYSA-N 2-methyl-7h-purine Chemical compound CC1=NC=C2NC=NC2=N1 KMEBCRWKZZSRRT-UHFFFAOYSA-N 0.000 description 1
- 235000007627 Caesalpinia Nutrition 0.000 description 1
- 241000522234 Caesalpinia Species 0.000 description 1
- 101000939517 Homo sapiens Ubiquitin carboxyl-terminal hydrolase 2 Proteins 0.000 description 1
- 206010061218 Inflammation Diseases 0.000 description 1
- 229920000168 Microcrystalline cellulose Polymers 0.000 description 1
- 206010028813 Nausea Diseases 0.000 description 1
- 206010033557 Palpitations Diseases 0.000 description 1
- VMHLLURERBWHNL-UHFFFAOYSA-M Sodium acetate Chemical compound [Na+].CC([O-])=O VMHLLURERBWHNL-UHFFFAOYSA-M 0.000 description 1
- 102100029643 Ubiquitin carboxyl-terminal hydrolase 2 Human genes 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- WEVYAHXRMPXWCK-UHFFFAOYSA-N acetonitrile Substances CC#N WEVYAHXRMPXWCK-UHFFFAOYSA-N 0.000 description 1
- 229960003556 aminophylline Drugs 0.000 description 1
- 230000006793 arrhythmia Effects 0.000 description 1
- 206010003119 arrhythmia Diseases 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 238000009835 boiling Methods 0.000 description 1
- 201000009267 bronchiectasis Diseases 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 238000004140 cleaning Methods 0.000 description 1
- 238000000576 coating method Methods 0.000 description 1
- 238000013270 controlled release Methods 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 238000013461 design Methods 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 238000007922 dissolution test Methods 0.000 description 1
- 230000000857 drug effect Effects 0.000 description 1
- -1 hydroxypropyl Chemical group 0.000 description 1
- 230000036039 immunity Effects 0.000 description 1
- 230000004054 inflammatory process Effects 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 229960001375 lactose Drugs 0.000 description 1
- 239000008101 lactose Substances 0.000 description 1
- 238000011068 loading method Methods 0.000 description 1
- FYYHWMGAXLPEAU-OUBTZVSYSA-N magnesium-25 atom Chemical group [25Mg] FYYHWMGAXLPEAU-OUBTZVSYSA-N 0.000 description 1
- 235000012054 meals Nutrition 0.000 description 1
- 238000000691 measurement method Methods 0.000 description 1
- 229940016286 microcrystalline cellulose Drugs 0.000 description 1
- 235000019813 microcrystalline cellulose Nutrition 0.000 description 1
- 239000008108 microcrystalline cellulose Substances 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 230000008693 nausea Effects 0.000 description 1
- 235000016709 nutrition Nutrition 0.000 description 1
- 230000035764 nutrition Effects 0.000 description 1
- 239000011148 porous material Substances 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 239000012488 sample solution Substances 0.000 description 1
- 238000010008 shearing Methods 0.000 description 1
- 239000001632 sodium acetate Substances 0.000 description 1
- 235000017281 sodium acetate Nutrition 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 229910001220 stainless steel Inorganic materials 0.000 description 1
- 239000010935 stainless steel Substances 0.000 description 1
- 238000013179 statistical model Methods 0.000 description 1
- 238000003756 stirring Methods 0.000 description 1
- 238000010998 test method Methods 0.000 description 1
Classifications
-
- 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
- A61K31/522—Purines, e.g. adenine having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
-
- 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
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- 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
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/06—Antiasthmatics
Landscapes
- Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Pulmonology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Description
Claims (7)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN202311226686.1A CN116966157B (en) | 2023-09-22 | 2023-09-22 | Theophylline sustained release tablet and preparation method thereof |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN202311226686.1A CN116966157B (en) | 2023-09-22 | 2023-09-22 | Theophylline sustained release tablet and preparation method thereof |
Publications (2)
Publication Number | Publication Date |
---|---|
CN116966157A CN116966157A (en) | 2023-10-31 |
CN116966157B true CN116966157B (en) | 2024-02-09 |
Family
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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CN202311226686.1A Active CN116966157B (en) | 2023-09-22 | 2023-09-22 | Theophylline sustained release tablet and preparation method thereof |
Country Status (1)
Country | Link |
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CN (1) | CN116966157B (en) |
Citations (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN85108712A (en) * | 1985-11-15 | 1987-05-20 | 信谊药厂 | A kind of manufacture method of Slow-release Theophylline |
US4795645A (en) * | 1986-03-03 | 1989-01-03 | Yissum Research And Development | Sustained release tablets of theophylline |
CN101590022A (en) * | 2008-05-29 | 2009-12-02 | 焦作平光制药有限责任公司 | Theophylline sodium glycinate slow-release tablet and preparation method thereof |
CN103239419A (en) * | 2013-05-15 | 2013-08-14 | 瑞阳制药有限公司 | Method for preparing theophylline sustained release |
CN106074426A (en) * | 2016-06-23 | 2016-11-09 | 南京华宽信息咨询中心 | A kind of Theo-Dur treating bronchial asthma and preparation method thereof |
CN107550880A (en) * | 2017-10-31 | 2018-01-09 | 瑞阳制药有限公司 | 24 hours sustained release tablets of theophylline and preparation method thereof |
CN109925290A (en) * | 2017-12-18 | 2019-06-25 | 广州白云山明兴制药有限公司 | Theo-Dur and its preparation process |
CN111202716A (en) * | 2018-11-05 | 2020-05-29 | 广州白云山光华制药股份有限公司 | Theophylline sustained release tablet and preparation method thereof |
CN115887397A (en) * | 2022-11-30 | 2023-04-04 | 广州茂丰药业有限公司 | Theophylline skeleton type slow-release core material, preparation method thereof and theophylline slow-release tablet |
-
2023
- 2023-09-22 CN CN202311226686.1A patent/CN116966157B/en active Active
Patent Citations (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN85108712A (en) * | 1985-11-15 | 1987-05-20 | 信谊药厂 | A kind of manufacture method of Slow-release Theophylline |
US4795645A (en) * | 1986-03-03 | 1989-01-03 | Yissum Research And Development | Sustained release tablets of theophylline |
CN101590022A (en) * | 2008-05-29 | 2009-12-02 | 焦作平光制药有限责任公司 | Theophylline sodium glycinate slow-release tablet and preparation method thereof |
CN103239419A (en) * | 2013-05-15 | 2013-08-14 | 瑞阳制药有限公司 | Method for preparing theophylline sustained release |
CN106074426A (en) * | 2016-06-23 | 2016-11-09 | 南京华宽信息咨询中心 | A kind of Theo-Dur treating bronchial asthma and preparation method thereof |
CN107550880A (en) * | 2017-10-31 | 2018-01-09 | 瑞阳制药有限公司 | 24 hours sustained release tablets of theophylline and preparation method thereof |
CN109925290A (en) * | 2017-12-18 | 2019-06-25 | 广州白云山明兴制药有限公司 | Theo-Dur and its preparation process |
CN111202716A (en) * | 2018-11-05 | 2020-05-29 | 广州白云山光华制药股份有限公司 | Theophylline sustained release tablet and preparation method thereof |
CN115887397A (en) * | 2022-11-30 | 2023-04-04 | 广州茂丰药业有限公司 | Theophylline skeleton type slow-release core material, preparation method thereof and theophylline slow-release tablet |
Non-Patent Citations (2)
Title |
---|
尤特奇RS-PO/RL-PO制备缓释片的工艺研究;韩巧玲;张丽;徐凌云;姚清娇;张多成;;河北工业科技(06);全文 * |
尤特奇在口服固体制剂中的应用;李扬;李金;陶涛;;中国医药工业杂志(05);全文 * |
Also Published As
Publication number | Publication date |
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CN116966157A (en) | 2023-10-31 |
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SE01 | Entry into force of request for substantive examination | ||
GR01 | Patent grant | ||
GR01 | Patent grant | ||
CP03 | Change of name, title or address |
Address after: Floor 4, Building D, Biomedical Innovation Park, No. 1, Lutai Avenue, High tech Zone, Zibo City, Shandong Province 255,035 Patentee after: SHANDONG HI-QUAL PHARMATECH CO.,LTD. Country or region after: China Patentee after: Shanghai Zezheng Pharmaceutical Technology Co.,Ltd. Address before: Floor 4, Building D, Biomedical Innovation Park, No. 1, Lutai Avenue, High tech Zone, Zibo City, Shandong Province 255,035 Patentee before: SHANDONG HI-QUAL PHARMATECH CO.,LTD. Country or region before: China Patentee before: Shanghai Zezheng Biopharmaceutical Co.,Ltd. Address after: Floor 4, Building D, Biomedical Innovation Park, No. 1, Lutai Avenue, High tech Zone, Zibo City, Shandong Province 255,035 Patentee after: SHANDONG HI-QUAL PHARMATECH CO.,LTD. Country or region after: China Patentee after: Shanghai Zezheng Biopharmaceutical Co.,Ltd. Address before: Floor 4, Building D, Biomedical Innovation Park, No. 1, Lutai Avenue, High tech Zone, Zibo City, Shandong Province 255,035 Patentee before: SHANDONG HI-QUAL PHARMATECH CO.,LTD. Country or region before: China Patentee before: Zezheng (Shanghai) Biotechnology Co.,Ltd. |
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CP03 | Change of name, title or address |