CN1206988C - 硫酸阿托品眼用凝胶 - Google Patents
硫酸阿托品眼用凝胶 Download PDFInfo
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- CN1206988C CN1206988C CN 02117622 CN02117622A CN1206988C CN 1206988 C CN1206988 C CN 1206988C CN 02117622 CN02117622 CN 02117622 CN 02117622 A CN02117622 A CN 02117622A CN 1206988 C CN1206988 C CN 1206988C
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- HOBWAPHTEJGALG-JKCMADFCSA-N [(1r,5s)-8-methyl-8-azoniabicyclo[3.2.1]octan-3-yl] 3-hydroxy-2-phenylpropanoate;sulfate Chemical compound [O-]S([O-])(=O)=O.C([C@H]1CC[C@@H](C2)[NH+]1C)C2OC(=O)C(CO)C1=CC=CC=C1.C([C@H]1CC[C@@H](C2)[NH+]1C)C2OC(=O)C(CO)C1=CC=CC=C1 HOBWAPHTEJGALG-JKCMADFCSA-N 0.000 title claims abstract description 38
- 229960002028 atropine sulfate Drugs 0.000 title claims abstract description 38
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- XIWFQDBQMCDYJT-UHFFFAOYSA-M benzyl-dimethyl-tridecylazanium;chloride Chemical compound [Cl-].CCCCCCCCCCCCC[N+](C)(C)CC1=CC=CC=C1 XIWFQDBQMCDYJT-UHFFFAOYSA-M 0.000 claims abstract description 11
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- 229930003347 Atropine Natural products 0.000 claims description 2
- RKUNBYITZUJHSG-UHFFFAOYSA-N Hyosciamin-hydrochlorid Natural products CN1C(C2)CCC1CC2OC(=O)C(CO)C1=CC=CC=C1 RKUNBYITZUJHSG-UHFFFAOYSA-N 0.000 claims description 2
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- 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 7
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- MYSWGUAQZAJSOK-UHFFFAOYSA-N ciprofloxacin Chemical compound C12=CC(N3CCNCC3)=C(F)C=C2C(=O)C(C(=O)O)=CN1C1CC1 MYSWGUAQZAJSOK-UHFFFAOYSA-N 0.000 description 2
- KWGRBVOPPLSCSI-UHFFFAOYSA-N d-ephedrine Natural products CNC(C)C(O)C1=CC=CC=C1 KWGRBVOPPLSCSI-UHFFFAOYSA-N 0.000 description 2
- 229960002179 ephedrine Drugs 0.000 description 2
- -1 ester sulfate monohydrate Chemical class 0.000 description 2
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- 229940126701 oral medication Drugs 0.000 description 2
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- 229940099259 vaseline Drugs 0.000 description 2
- GSDSWSVVBLHKDQ-UHFFFAOYSA-N 9-fluoro-3-methyl-10-(4-methylpiperazin-1-yl)-7-oxo-2,3-dihydro-7H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic acid Chemical compound FC1=CC(C(C(C(O)=O)=C2)=O)=C3N2C(C)COC3=C1N1CCN(C)CC1 GSDSWSVVBLHKDQ-UHFFFAOYSA-N 0.000 description 1
- 206010070840 Gastrointestinal tract irritation Diseases 0.000 description 1
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- ZADPBFCGQRWHPN-UHFFFAOYSA-N boronic acid Chemical compound OBO ZADPBFCGQRWHPN-UHFFFAOYSA-N 0.000 description 1
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- 229960003405 ciprofloxacin Drugs 0.000 description 1
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- 229960001699 ofloxacin Drugs 0.000 description 1
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- 229940054534 ophthalmic solution Drugs 0.000 description 1
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Abstract
本发明涉及一种药物有效成分-硫酸阿托品-首次制成眼用凝胶剂，硫酸阿托品能选择性的阻断M-胆碱能受体，能对抗乙酰胆碱及其拟胆碱药的M-受体激动作用，能接触平滑肌痉挛，能拟制腺体分泌，散大瞳孔。本发明首次将硫酸阿托品制成眼用凝胶，不仅解决了滴眼液易被泪液稀释、眼内停留时间短的问题；而且，提高药物有效成分的生物利用度，增加疗效和用药安全性。主要技术内容是：硫酸阿托品，羟丙甲基纤维素，硼酸，硼砂，氯化苯甲烃胺制成稳定的水溶性透明乳膏体，使用后在眼表形成一层透气的网状膜，作用持久，主要用于眼底检查及验光前的散疃，眼科手术术前散瞳，术后防止粘连，也可以用于角膜炎、虹膜睫状体炎等的治疗。
Description
所属技术领域
本发明涉及一种药物有效成分——硫酸阿托品——首次制成眼用凝胶，应用于眼科手术术前散瞳，术后防止粘连。也可以用于角膜炎、虹膜睫状体炎等的治疗。
背景技术
国内临床上除使用片剂、注射液外，眼科制剂常使用1.0％眼膏(以凡士林为基质)；国外眼科用药中除使用1.0％眼膏外，还使用1.0％硫酸阿托品滴眼液。硫酸阿托品眼用凝胶的开发和使用未见报道，在国内医疗机构的医院制剂中有使用凝胶剂者(非眼用)，据反映，效果很好。硫酸阿托品眼用凝胶剂目前还未见有研究和生产的报道。
发明内容
为了克服给药量大，口服药物难以通过血眼屏障的不足，发明一种眼用凝胶，眼科局部给药，不仅解决了滴眼液易被泪液稀释，眼内停留时间短的问题，且使用量少，提高药物有效成分的生物利用度，增加疗效和用药安全性。
本发明的技术方案是：硫酸阿托品药物成分与羟丙甲基纤维素膏体基质形成稳定的透明膏体，施用后在眼表形成一层透气的网状膜，作用持久。其具体特征如下：
硫酸阿托品眼用凝胶单方制剂，通用名：硫酸阿托品眼用凝胶；化学名：α-(羟甲基)苯乙酸-8-甲基-氮杂双环[3、2、1]-3-辛酯硫酸盐一水合物；英文名：Atropine sulfate ophthalmic gel；汉语拼音：Liusuan Atuopin yanyongningjiao；硫酸阿托品眼用凝胶为硫酸阿托品的单方制剂，根据制剂名称与原料相一致的原则，本品命名为硫酸阿托品眼用凝胶。硫酸阿托品药物与主要辅料成分及其按下列比例组成的应用于眼科疾患的制剂：其中含硫酸阿托品为0.1-5.0％(w/w)；含羟丙甲基纤维素为0-20.0％(w/w)；含硼酸为0-5.0％(w/w)；含硼砂为0-10.0％(w/w)；含氯化苯甲烃胺为0-0.05％(w/w)。取处方量的羟丙甲基纤维素用400ml注射用水溶胀，过夜。取处方量的硼砂、硼酸加入其中，搅拌均匀，制成透明凝胶基质；加入氯化苯甲烃胺，搅拌使溶解；加入硫酸阿托品药物有效成分，补水至全量，充分搅拌均匀；用220目筛布过滤，热压灭菌，分装，即得。另外，硫酸阿托品与卡泊姆系列、甲基纤维素系列、聚乙烯醇系列等基质均可形成凝胶，羟丙甲基纤维素系列基质效果最好。上述制备工艺中，其核心技术是：(1)羟丙甲基纤维素酸性条件下(pH＝5.0-6.0)以注射用水溶胀，(2)与硼砂、硼酸等辅料成分混合加热溶解(温度范围60-80℃)是保证膏体透明的关键，(3)加入硫酸阿托品药物有效成分适当温度下(45-55℃)搅拌溶解，(4)热压灭菌(115℃，30分钟)。
本发明的积极效果：硫酸阿托品眼用凝胶的研制与开发有以下优点：(1)、硫酸阿托品眼用凝胶直接作用于患处，能充分有效地发挥作用，可避免口服药物治疗所带来的胃肠道刺激和其他副作用。(2)、相对于其它眼用制剂，凝胶剂具有无可比拟的优点。和滴眼液相比硫酸阿托品眼用凝胶不易被泪液稀释，在眼内停留时间长，有利于主要的充分吸收和利用；和凡士林基质的眼膏相比，硫酸阿托品眼用凝胶水溶性好，容易清洗，不污染衣物，使用方便。另一方面，硫酸阿托品眼用凝胶不造成视野模糊，昼夜都可使用。本产品的开发成功，不仅可填补国内眼科用药的一项空白，还可带来很好的社会效益和经济效益。(3)、我们企业是国内专业的眼科用药生产厂家，30多年来一直致力于眼药的生产、研制、开发，积极参加社会公益事业，眼科用药占总产值的90％以上。尤其是，我们有环丙沙星滴眼液、氧氟沙星滴眼液(眼膏)的生产、开发经验。硫酸阿托品眼用凝胶一旦开发成功，必然会受到广大医生和患者的欢迎。
实施例
处方1：
硫酸阿托品 1.0克
羟丙甲基纤维素 4.0克
硼砂 1.0克
硼酸 0.5克
氯化苯甲烃胺 0.01克
注射用水 制成100克
操作过程：
①.取处方量的羟丙甲基纤维素用适量注射用水溶胀，过夜。
②.取处方量的硼砂、硼酸加入其中，搅拌均匀，加热制成透明凝胶基质；
③.加入氯化苯甲烃胺，搅拌使溶解；
④.加入硫酸阿托品，补水至全量，充分搅拌均匀；
⑤.用220目筛布过滤，热压灭菌，分装，即得。
处方2：
硫酸阿托品 0.1-5.0克
羟丙甲基纤维索 0.1-20.0克
硼砂 0.1-5.0克
硼酸 0.1-2.5克
氯化苯甲烃胺 0.01-0.5克
注射用水 制成100克
操作过程：
①.取处方量的羟丙甲基纤维素用适量注射用水溶胀，过夜。
②.取处方量的硼砂、硼酸加入其中，搅拌均匀，加热制成透明凝胶基质；
③.加入氯化苯甲烃胺，搅拌使溶解；
④.加入硫酸阿托品，补水至全量，充分搅拌均匀；
⑤.用220目筛布过滤，热压灭菌，分装，即得。
本发明的创造性，通过临床、毒理药理数据来实现，实质审查时一并提供。
图1为硫酸阿托品眼用凝胶制备工艺流程图。
Claims (4)
1.一种硫酸阿托品眼用凝胶，其特征在于：以重量计含有硫酸阿托品0.1～5.0％，羟丙甲纤维素0.1～20.0％，硼酸0.1～5.0％，硼砂0.1～10.0％，氯化苯甲烃胺0.01～0.05％。
2.根据权利要求1的硫酸阿托品眼用凝胶，其特征在于：以重量计含有硫酸阿托品0.1～5.0％，羟丙甲纤维素0.1～20.0％，硼酸0.1～2.5％，硼砂0.1～5.0％，氯化苯甲烃胺0.01～0.05％。
3.根据权利要求1的硫酸阿托品眼用凝胶，其特征在于：以重量计含硫酸阿托品1.0％，羟丙甲纤维素4.0％，硼酸0.5％，硼砂1.0％，氯化苯甲烃胺0.01％。
4.权利要求1的硫酸阿托品眼用凝胶的制备方法，将羟丙甲纤维素溶胀成水溶液，加入硼砂、硼酸，搅拌均匀，制成透明凝胶基质；加入氯化苯甲烃胺，搅拌使溶解，加入硫酸阿托品。
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 02117622 CN1206988C (zh) | 2002-05-10 | 2002-05-10 | 硫酸阿托品眼用凝胶 |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 02117622 CN1206988C (zh) | 2002-05-10 | 2002-05-10 | 硫酸阿托品眼用凝胶 |
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| CN1456161A CN1456161A (zh) | 2003-11-19 |
| CN1206988C true CN1206988C (zh) | 2005-06-22 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN 02117622 Expired - Lifetime CN1206988C (zh) | 2002-05-10 | 2002-05-10 | 硫酸阿托品眼用凝胶 |
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Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101322683B (zh) * | 2008-07-30 | 2013-01-16 | 浙江三叶药业有限公司 | 一种含有溴芬酸钠水合物的眼用凝胶剂及其制备方法 |
| WO2016172712A2 (en) | 2015-04-23 | 2016-10-27 | Sydnexis, Inc. | Ophthalmic composition |
| US9421199B2 (en) | 2014-06-24 | 2016-08-23 | Sydnexis, Inc. | Ophthalmic composition |
| US11382909B2 (en) | 2014-09-05 | 2022-07-12 | Sydnexis, Inc. | Ophthalmic composition |
| EP3302426A4 (en) | 2015-05-29 | 2018-12-05 | Sydnexis, Inc. | D2o stabilized pharmaceutical formulations |
| CN107456440A (zh) * | 2017-08-07 | 2017-12-12 | 杭州赫尔斯科技有限公司 | 一种低浓度阿托品类药物滴眼液及其制备方法 |
| CN107982212A (zh) * | 2017-11-28 | 2018-05-04 | 杭州赫尔斯科技有限公司 | 一种阿托品类药物缓释滴眼液及其制备方法 |
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2002
- 2002-05-10 CN CN 02117622 patent/CN1206988C/zh not_active Expired - Lifetime
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| CN1456161A (zh) | 2003-11-19 |
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