CN106265567A - 一种水溶性氨茶碱片及其制备方法 - Google Patents
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- 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 title claims abstract description 52
- 229960003556 aminophylline Drugs 0.000 title claims abstract description 51
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 title claims abstract description 32
- 238000002360 preparation method Methods 0.000 title claims description 10
- 229920002472 Starch Polymers 0.000 claims abstract description 29
- 239000008107 starch Substances 0.000 claims abstract description 29
- 235000019698 starch Nutrition 0.000 claims abstract description 29
- 229920000858 Cyclodextrin Polymers 0.000 claims abstract description 17
- GDSRMADSINPKSL-HSEONFRVSA-N gamma-cyclodextrin Chemical compound OC[C@H]([C@H]([C@@H]([C@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O3)[C@H](O)[C@H]2O)CO)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H]3O[C@@H]1CO GDSRMADSINPKSL-HSEONFRVSA-N 0.000 claims abstract description 17
- 229940080345 gamma-cyclodextrin Drugs 0.000 claims abstract description 17
- 229920003063 hydroxymethyl cellulose Polymers 0.000 claims abstract description 17
- 229940031574 hydroxymethyl cellulose Drugs 0.000 claims abstract description 17
- 239000002994 raw material Substances 0.000 claims abstract description 12
- 239000008118 PEG 6000 Substances 0.000 claims description 15
- 229920002584 Polyethylene Glycol 6000 Polymers 0.000 claims description 15
- 239000008187 granular material Substances 0.000 claims description 8
- 239000011230 binding agent Substances 0.000 claims description 7
- 239000002002 slurry Substances 0.000 claims description 6
- ZFXYFBGIUFBOJW-UHFFFAOYSA-N theophylline Chemical compound O=C1N(C)C(=O)N(C)C2=C1NC=N2 ZFXYFBGIUFBOJW-UHFFFAOYSA-N 0.000 claims description 6
- 238000004806 packaging method and process Methods 0.000 claims description 4
- QGZKDVFQNNGYKY-UHFFFAOYSA-N Ammonia Chemical compound N QGZKDVFQNNGYKY-UHFFFAOYSA-N 0.000 claims 2
- 229910021529 ammonia Inorganic materials 0.000 claims 1
- 229960000278 theophylline Drugs 0.000 claims 1
- 239000003814 drug Substances 0.000 abstract description 5
- 238000005516 engineering process Methods 0.000 abstract description 3
- 238000000034 method Methods 0.000 abstract description 3
- 239000003651 drinking water Substances 0.000 abstract description 2
- 235000020188 drinking water Nutrition 0.000 abstract description 2
- 230000000144 pharmacologic effect Effects 0.000 abstract description 2
- 239000007962 solid dispersion Substances 0.000 abstract description 2
- 239000000126 substance Substances 0.000 abstract description 2
- 239000000203 mixture Substances 0.000 description 5
- PIICEJLVQHRZGT-UHFFFAOYSA-N Ethylenediamine Chemical compound NCCN PIICEJLVQHRZGT-UHFFFAOYSA-N 0.000 description 4
- 230000002950 deficient Effects 0.000 description 4
- 239000000843 powder Substances 0.000 description 4
- 229960004674 theophylline anhydrous Drugs 0.000 description 4
- 239000003795 chemical substances by application Substances 0.000 description 3
- 238000010521 absorption reaction Methods 0.000 description 2
- 230000006378 damage Effects 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 238000001035 drying Methods 0.000 description 2
- 238000012856 packing Methods 0.000 description 2
- 239000000273 veterinary drug Substances 0.000 description 2
- 238000004260 weight control Methods 0.000 description 2
- 210000005091 airway smooth muscle Anatomy 0.000 description 1
- 238000009360 aquaculture Methods 0.000 description 1
- 244000144974 aquaculture Species 0.000 description 1
- 238000013270 controlled release Methods 0.000 description 1
- 239000006184 cosolvent Substances 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 239000000314 lubricant Substances 0.000 description 1
- 150000003839 salts Chemical class 0.000 description 1
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- 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
- A61K31/522—Purines, e.g. adenine having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
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- 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
- A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
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- 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
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- 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
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Abstract
一种水溶性氨茶碱片，由以下重量份的原料制备而成：氨茶碱30‑40份、γ‑环糊精40‑60份、PEG‑6000 0.1‑0.5份、淀粉1‑5份、羟甲基纤维素2‑5份；优选的：由以下重量份的原料制备而成：氨茶碱35份、γ‑环糊精50份、PEG‑6000 0.3份、淀粉3份、羟甲基纤维素3.5份。本发明提供的水溶性氨茶碱片，加工简单，设备投资少，采用固体分散技术对难溶性原料进行理化处理，在不改变其化学结构和药理作用的前提下，明显提高了氨茶碱片的水溶性，增强了药物进入体内的缓释作用，使产品能满足饮水使用，更能适应市场的集约化养殖。
Description
技术领域
本发明属于兽药加工技术领域，具体涉及一种水溶性氨茶碱片及其制备方法。
背景技术
氨茶碱为茶碱与乙二胺复盐，对呼吸道平滑肌有直接松弛作用，目前兽药市场上氨茶碱片主要为非水溶性的，加上养殖模式的变化，由散养转变为集约化养殖，因此，市场用药对药品的水溶性要求不断提高。
发明内容
本发明的目的就在于提供一种水溶性氨茶碱片及其制备方法。
本发明的目的是以下述方式实现的：
一种水溶性氨茶碱片，由以下重量份的原料制备而成：氨茶碱30-40份、γ-环糊精40-60份、PEG-6000 0.1-0.5份、淀粉1-5份、羟甲基纤维素2-5份；优选的：由以下重量份的原料制备而成：氨茶碱35份、γ-环糊精50份、PEG-6000 0.3份、淀粉3份、羟甲基纤维素3.5份。
如上所述的水溶性氨茶碱片的制备方法，包括以下步骤：
（1）将氨茶碱和γ-环糊精混合粉碎，过60-100目筛，然后和羟甲基纤维素混合均匀，
（2）以淀粉和水制作成淀粉含量为8%-15%的淀粉浆作粘合剂，进行制粒，在40-50℃下烘干；
（3）整粒；
（4）加入PEG-6000作为水溶性润滑剂；
（5）压片；包装。
本发明提供的水溶性氨茶碱片，加工简单，设备投资少，采用固体分散技术对难溶性原料进行理化处理，在不改变其化学结构和药理作用的前提下，明显提高了氨茶碱片的水溶性，增强了药物进入体内的缓释作用，使产品能满足饮水使用，更能适应市场的集约化养殖。
具体实施方式
实施例1
一种水溶性氨茶碱片，由以下重量份的原料制备而成：氨茶碱30-40份、γ-环糊精40-60份、PEG-6000 0.1-0.5份、淀粉1-5份、羟甲基纤维素2-5份。
如上所述的水溶性氨茶碱片的制备方法，包括以下步骤：
（1）氨茶碱根据药典要求，无水茶碱比例为74.0-84.0%，乙二胺不少于11.25；将满足上述条件的氨茶碱和γ-环糊精混合粉碎，过60-100目筛，然后和羟甲基纤维素混合均匀，
（2）以淀粉和水制作成淀粉含量为8%-15%的淀粉浆作粘合剂，用24目筛进行制粒，在40-50℃下烘干，避免温度过高对氨茶碱的破坏；
（3）整粒，筛去多余细粉（60目）和不合格粗颗粒；
（4）加入PEG-6000作为水溶性润滑剂；
（5）压片；片重控制在0.5g/片，各车间应控制温湿度，温度在25℃左右，湿度在30-45%，防止片剂吸潮，出现粘冲现象；按照产品包装规格进行包装，包装之前应挑选不合格片剂，筛去细粉。
本发明氨茶碱以γ-环糊精为包合剂，增加主药稳定性，控制药物释放速度，启到缓释作用，以PEG-6000为助溶剂和润滑剂，以淀粉和羟甲基纤维素为崩解剂、粘合剂，制得的氨茶碱片（氨茶碱0.2g/片，片重0.5g/片）在200mL的温水（30-40℃）中可溶解10片，在3min内完全溶解，溶液基本澄清，当添加到12片时，溶液澄清度尚好，14片时溶液有些浑浊，因此，在100mL温水中，可以溶解5-6片 本发明制备的氨茶碱片，溶液澄清，药液中氨茶碱含量可以达到1.2g/100mL。
实施例2
一种水溶性氨茶碱片，由以下重量份的原料制备而成：氨茶碱35份、γ-环糊精50份、PEG-6000 0.3份、淀粉3份、羟甲基纤维素3.5份。
如上所述的水溶性氨茶碱片的制备方法，包括以下步骤：
（1）氨茶碱根据药典要求，无水茶碱比例为74.0-84.0%，乙二胺不少于11.25；将满足上述条件的氨茶碱和γ-环糊精混合粉碎，过80目筛，然后和羟甲基纤维素混合均匀；
（2）以淀粉和水制作成淀粉含量为11%的淀粉浆作粘合剂，用24目筛进行制粒，在45℃下烘干；避免温度过高对氨茶碱的破坏；
（3）整粒，筛去多余细粉（60目）和不合格粗颗粒，
（4）加入PEG-6000作为水溶性润滑剂；
（5）压片；片重控制在0.5g/片，各车间应控制温湿度，温度在25℃左右，湿度在30-45%，防止片剂吸潮，出现粘冲现象；按照产品包装规格进行包装，包装之前应挑选不合格片剂，筛去细粉。
实施例3
一种水溶性氨茶碱片，由以下重量份的原料制备而成：氨茶碱30份、γ-环糊精55份、PEG-6000 0.3份、淀粉4份、羟甲基纤维素4份。
如上所述的水溶性氨茶碱片的制备方法，包括以下步骤：
（1）氨茶碱根据药典要求，无水茶碱比例为74.0-84.0%，乙二胺不少于11.25；将满足上述条件的氨茶碱和γ-环糊精混合粉碎，过100目筛，然后和羟甲基纤维素混合均匀；
（2）以淀粉和水制作成淀粉含量为15%的淀粉浆作粘合剂，用24目筛进行制粒，在40℃下烘干；
（3）整粒；
（4）加入PEG-6000作为水溶性润滑剂；
（5）压片。
实施例4
一种水溶性氨茶碱片，由以下重量份的原料制备而成：氨茶碱35份、γ-环糊精45份、PEG-6000 0.4份、淀粉4份、羟甲基纤维素3份。
如上所述的水溶性氨茶碱片的制备方法，包括以下步骤：
（1）氨茶碱根据药典要求，无水茶碱比例为74.0-84.0%，乙二胺不少于11.25；将满足上述条件的氨茶碱和γ-环糊精混合粉碎，过60目筛，然后和羟甲基纤维素混合均匀；
（2）以淀粉和水制作成淀粉含量为8%的淀粉浆作粘合剂，用24目筛进行制粒，在50℃下烘干；
（3）整粒；
（4）加入PEG-6000作为水溶性润滑剂；
（5）压片。
本发明实施例5-18水溶性氨茶碱片配方见表1-2，其他同实施例2。
以上所述的仅是本发明的优选实施方式，应当指出，对于本领域的技术人员来说，在不脱离本发明整体构思前提下，还可以作出若干改变和改进，这些也应该视为本发明的保护范围。
Claims (3)
1.一种水溶性氨茶碱片，其特征在于由以下重量份的原料制备而成：氨茶碱30-40份、γ-环糊精40-60份、PEG-6000 0.1-0.5份、淀粉1-5份、羟甲基纤维素2-5份。
2.如权利要求1所述的水溶性氨茶碱片，其特征在于由以下重量份的原料制备而成：氨茶碱35份、γ-环糊精50份、PEG-6000 0.3份、淀粉3份、羟甲基纤维素3.5份。
3.如权利要求1-2任一项所述的水溶性氨茶碱片的制备方法，其特征在于包括以下步骤：
（1）将氨茶碱和γ-环糊精混合粉碎，过60-100目筛，然后和羟甲基纤维素混合均匀；
（2）以淀粉和水制作成淀粉含量为8%-15%的淀粉浆作粘合剂，进行制粒，在40-50℃下烘干；
（3）整粒；
（4）加入PEG-6000作为水溶性润滑剂；
（5）压片；包装。
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FR2390164B1 (zh) * | 1977-05-13 | 1980-07-18 | Blanie Paul | |
| CN1424112A (zh) * | 2002-12-17 | 2003-06-18 | 上海医药工业研究院 | 难溶性药物的水溶性包合物及其制备方法 |
| CN101199531A (zh) * | 2006-12-11 | 2008-06-18 | 何德义 | 小儿氨茶碱可溶片 |
| CN103877052A (zh) * | 2014-03-27 | 2014-06-25 | 哈药集团制药总厂 | 一种氨茶碱片及其制备方法 |
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Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FR2390164B1 (zh) * | 1977-05-13 | 1980-07-18 | Blanie Paul | |
| CN1424112A (zh) * | 2002-12-17 | 2003-06-18 | 上海医药工业研究院 | 难溶性药物的水溶性包合物及其制备方法 |
| CN101199531A (zh) * | 2006-12-11 | 2008-06-18 | 何德义 | 小儿氨茶碱可溶片 |
| CN103877052A (zh) * | 2014-03-27 | 2014-06-25 | 哈药集团制药总厂 | 一种氨茶碱片及其制备方法 |
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