CN1281217C - 活性碳在制备治疗甲亢症的口服药物制剂中的应用 - Google Patents
活性碳在制备治疗甲亢症的口服药物制剂中的应用 Download PDFInfo
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Abstract
本发明涉及活性碳在制备治疗甲亢症的口服药物制剂的应用。使用本发明的口服药物中含活性碳剂量在每日1g-100g即可，患者服用后无不良反应。活性碳将结合排入小肠的甲状腺激素，阻断甲状腺激素的肠肝循环，将增加甲状腺激素的肠道排泄，使血清中甲状腺激素水平迅速下降。完全适用于使用抗甲状腺药物有禁忌的各种临床情况及抗甲状腺药物不能及时起效的各种临床情况。
Description
本发明涉及药物的新用途，特别是活性碳在制备治疗甲亢症的口服药物制剂中的应用。
甲状腺功能亢进症是一组常见的临床综合征，已有调查结果显示，本病人群患病率大致在0.5％-1.5％之间，目前国内本病发病率呈明显上升的趋势，已成为内分泌科、核医学科等相关科室门诊、住院的最主要的病种之一。其主要表现为血清甲状腺激素水平增高，并由此引起一系列代谢增高的临床症状，如易饥、多汗、消瘦、腹泻等。由于该病使患者处于高代谢状态，如果不能及时控制病情，患者将出现一系列严重的并发症如甲亢性心脏病、甲亢肌病、骨质疏松症、电解质紊乱等，因而引起了医学界的高度重视。但对引起甲亢最主要的病因即Graves病的发病机制的认识却仍没有本质的突破，治疗也基本停留在20世纪70年代的水平。目前的治疗措施也存在一些让人失望的缺点，可大致归纳如下：(1)抗甲状腺药物治疗：该方法起效缓慢，即使采用足量的药物进行治疗，仍需要4-8周甚至更长时间才可使患者的甲状腺激素水平基本恢复正常，临床症状方可缓解。在治疗初期，由于用药剂量较大，需要医生仔细观察患者用药后有无粒细胞下降、过敏反应、肝功能异常等不良反应的发生，如果患者进行门诊治疗，显得并不方便。但是如果进行住院治疗，患者并不情愿在甲亢症状未被控制的情况下出院；如果患者待甲亢症状完全缓解后出院，将明显增加住院时间，极大地浪费医疗资源，并增加医疗费用。对于重症甲亢、严重甲亢性心脏病或甲亢危象患者，由于这种治疗方式起效慢，不能及时、有效地缓解病情，患者随时存在生命危险。对于妊娠期或哺乳期甲亢患者、粒细胞明显减少或缺乏患者、甲亢药物过敏者等等也并不适合采用本治疗方法，但这些情况临床上却并不少见。(2)I131进行同位素治疗或外科手术治疗：在实施此类治疗前需要将甲状腺激素水平控制到正常或接近正常的范围，采用普通抗甲状腺药物将需要太长时间进行术前准备；在实施此类治疗后，又由于甲状腺滤泡的大量破坏或甲状腺激惹而释放大量的甲状腺激素入血，甲状腺激素水平将一过性地明显增高，甲亢症状也随之加重。在这些情况下都需要采用更积极的治疗措施以迅速降低甲状腺激素水平，但抗甲状腺药物却不能在短时间内完全达到预期效果，临床上存在许多具体的困难。而妊娠期或哺乳期甲亢患者、严重甲亢性心脏病患者、粒细胞明显减少或缺乏患者、甲亢危象患者等等，也不能采用上述这两种治疗方法(见高绪文、李继莲主编。甲状腺疾病。人民卫生出版社，1999，92-104。)
本发明正是为了克服上述现有技术中的不足之处，而提供一种用活性碳口服药物制剂结合排入小肠的甲状腺激素，阻断甲状腺激素的肠肝循环，将使甲亢治疗时甲状腺激素水平迅速下降。为已有活性碳口服制剂增加新用途。
本发明在治疗甲状腺亢进的口服药物制剂中主要应用了活性碳1g-100g及其辅料。其新用途的作用原理如下：甲状腺功能亢进症是由于血清甲状腺激素水平增高而产生的，要成功治疗甲亢，应该首先将甲状腺激素水平减低至正常。在正常情况下，甲状腺激素由甲状腺合成，并储存于甲状腺滤泡内，由甲状腺滤泡释放入血。血中的甲状腺激素包括结合于蛋白质和不结合于蛋白质(游离)两部分。游离甲状腺激素可产生较弱的生理功能。约2/3的游离甲状腺激素经肝脏脱碘酶作用，主要转变为活性极强的三碘甲状腺原胺酸而再次入血，并发挥甲状腺激素的生理作用；约1/3的游离甲状腺激素不经过脱碘而直接与葡萄糖醛酸或硫酸盐结合，随胆汁排入小肠，排入肠道的这一部分近一半将被重吸收入血，形成甲状腺激素的肠肝循环；未被肠道重吸收的部分即随粪便排出体外。在甲亢时，游离甲状腺激素水平明显增加，经肝脏排入小肠的甲状腺激素比例大大增加，参与肠肝循环的甲状腺激素的比例也明显增加。如果采用特定的药物结合排入小肠的甲状腺激素，阻断甲状腺激素的肠肝循环，将增加肠道内甲状腺激素的排泄，使血清中甲状腺激素水平迅速下降。这种特定的药物就是活性碳又称为药用碳。它在人肠道内呈不分解微粒状，不被吸收入血，又能达到上述效果。
本发明与现有技术相比具有如下优点：(1)安全性好，适用范围广。它既是国家基本药物，也是国家非处方药物，即使妊娠妇女应用也不受限制。它完全避免了现有甲亢治疗药物的不良反应，并适于所有甲亢患者。由于活性碳不吸收入血，仅在肠道起作用，没有普通抗甲状腺药物的任何不良反应，但却具有降低甲状腺激素水平的作用，完全适用于使用抗甲状腺药物有禁忌的各种临床情况，如抗甲状腺药物过敏、粒细胞减少或缺乏、妊娠及哺乳期患者，也适用于抗甲状腺药物不能及时起效的各种临床情况，如普通甲亢治疗初期、重症甲亢、甲亢危象、甲亢性心脏病、I131同位素治疗或外科手术治疗的术前准备及术后处理等。(2)起效快，疗效确切。经过近1年80余例患者的临床前瞻性研究表明：抗甲状腺药物合用活性碳的患者，其血清甲状腺激素水平(TT3、TT4、FT3、FT4)下降速度明显高于单用抗甲状腺药物者(相差两倍左右)，促甲状腺激素(TSH)上升速度明显高于单用抗甲状腺药物者(相差5倍左右)，临床症状缓解也更快，业已证明了采用口服活性碳制剂治疗甲亢的有效性。(3)经济、方便。由于本口服药物制剂可以更快地控制甲亢，将明显减少甲亢患者痛苦并节约患者的医疗费用。(4)无副作用。患者在使用该药物前后，血常规、肝肾功能、血脂、大小便常规等没有变化，临床观察也无其他不适。
本发明以下将结合实施例作进一步详述：
实施例1.一种活性碳在制备治疗甲亢症的口服药物制剂中的应用，其特别之处主要应用了活性碳在治疗甲亢症的口服药物制剂中。活性碳口服药物制剂配方可以是由活性碳30-80％、糊精4-15％、淀粉4-15％、淀粉浆4-15％、桃胶4-15％、桃胶浆3-40g、硬脂酸镁1-3％组成，制作成片剂。本实例活性碳口服药物制剂配方按每100g计：含活性碳80g糊精4g、淀粉4g、淀粉浆4g、桃胶4g、桃胶浆3g、硬脂酸镁1g。患者可每日服用含活性碳1g-100g以上的口服药物制剂，无明显的不良反应。
实施例2.一种活性碳在制备治疗甲亢症的口服药物制剂中的应用，其特别之处主要应用了活性碳在治疗甲亢症的口服药物制剂中。本实例活性碳口服药物制剂配方按每100g计：活性碳56g、糊精7g、淀粉7g、淀粉浆6g、桃胶6g、桃胶浆17g、硬脂酸镁1g组成。患者每日服用剂量在实施例1范围内无不良反应。
实施例3.一种活性碳在制备治疗甲亢症的口服药物制剂中的应用，其特别之处主要应用了活性碳在治疗甲亢症的口服药物制剂中。本实例活性碳口服药物制剂配方按每100g计：活性碳30g、糊精15g、淀粉15g、淀粉浆15g、桃胶15g、桃胶浆7g、硬脂酸镁3g组成。患者每日服用剂量在实施例1范围内无不良反应。
实施例4.一种活性碳在制备治疗甲亢症的口服药物制剂中的应用，其特别之处主要应用了活性碳在治疗甲亢症的口服药物制剂中。本实例活性碳口服药物制剂配方接每100g计：活性碳19g、糊精10g、淀粉10g、淀粉浆10g、桃胶10g、桃胶浆40g、硬脂酸镁1g组成。患者每日服用剂量在实施例1范围内无不良反应。
实施例5.一种活性碳在制备治疗甲亢症的口服药物制剂中的应用，其特别之处主要应用了活性碳在治疗甲亢症的口服药物制剂中。活性碳口服药物制剂也可以直接使用活性碳100g。患者每日服用100g后无不良反应。
实施例6.一种活性碳在制备治疗甲亢症的口服药物制剂中的应用，其特别之处主要应用了活性碳在治疗甲亢症的口服药物制剂中。活性碳口服药物制剂可以应用市售活性碳口服药物制剂。只要活性碳剂量在本发明范围内即可。
Claims (1)
1.一种活性碳在制备治疗甲亢症的口服药物制剂中的应用。
Priority Applications (8)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB01128840XA CN1281217C (zh) | 2001-09-13 | 2001-09-13 | 活性碳在制备治疗甲亢症的口服药物制剂中的应用 |
| JP2003526420A JP2005524604A (ja) | 2001-09-13 | 2002-09-09 | 活性炭を含有する経口製剤及びその用途 |
| DE60231997T DE60231997D1 (de) | 2001-09-13 | 2002-09-09 | Orale pharmazeutische formulierung mit aktivkohle und ihre verwendung |
| ES02754173T ES2322041T3 (es) | 2001-09-13 | 2002-09-09 | Formula farmaceutica oral con ingrediente activo de carbon y uso de la misma. |
| EP02754173A EP1437140B1 (en) | 2001-09-13 | 2002-09-09 | Oral pharmaceutical formulation containing active carbon and use of the same |
| US10/489,505 US20040265299A1 (en) | 2001-09-13 | 2002-09-09 | Oral pharmaceutical formulation containing active carbon and use of the same |
| PCT/CN2002/000630 WO2003022292A1 (fr) | 2001-09-13 | 2002-09-09 | Formulation pharmaceutique orale contenant du charbon actif et utilisation de cette formulation |
| AT02754173T ATE428432T1 (de) | 2001-09-13 | 2002-09-09 | Orale pharmazeutische formulierung mit aktivkohle und ihre verwendung |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB01128840XA CN1281217C (zh) | 2001-09-13 | 2001-09-13 | 活性碳在制备治疗甲亢症的口服药物制剂中的应用 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1406587A CN1406587A (zh) | 2003-04-02 |
| CN1281217C true CN1281217C (zh) | 2006-10-25 |
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| Application Number | Title | Priority Date | Filing Date |
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| CNB01128840XA Expired - Fee Related CN1281217C (zh) | 2001-09-13 | 2001-09-13 | 活性碳在制备治疗甲亢症的口服药物制剂中的应用 |
Country Status (8)
| Country | Link |
|---|---|
| US (1) | US20040265299A1 (zh) |
| EP (1) | EP1437140B1 (zh) |
| JP (1) | JP2005524604A (zh) |
| CN (1) | CN1281217C (zh) |
| AT (1) | ATE428432T1 (zh) |
| DE (1) | DE60231997D1 (zh) |
| ES (1) | ES2322041T3 (zh) |
| WO (1) | WO2003022292A1 (zh) |
Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100456950C (zh) * | 2003-06-20 | 2009-02-04 | 希尔氏宠物营养品公司 | 碘在制备用于预防猫的甲状腺机能亢进的饮食中的用途 |
| US8501223B2 (en) | 2003-06-20 | 2013-08-06 | Hill's Pet Nutrition, Inc. | Methods for dietary management of cats to avoid hyperthyroidism |
| EA017359B1 (ru) * | 2007-11-23 | 2012-11-30 | Фармалунденсис Аб | Способ и композиция для достижения бронхиальной релаксации |
| KR101593287B1 (ko) * | 2011-03-04 | 2016-02-11 | 가부시끼가이샤 구레하 | 정제형의 경구 투여용 조성물 및 그의 제조 방법 |
| CN110151792A (zh) * | 2019-06-06 | 2019-08-23 | 合肥元佑健康管理有限公司 | 一种治疗甲亢的中药方及其制备方法 |
| WO2021134482A1 (en) * | 2019-12-31 | 2021-07-08 | Fresenius Medical Care Deutschland Gmbh | Direct compressed activated carbon tablet formulation |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| US3642986A (en) * | 1970-04-01 | 1972-02-15 | William Arthur Welch | Aspirin-charcoal compositions |
| AU2027595A (en) * | 1994-05-27 | 1995-12-07 | Kureha Kagaku Kogyo Kabushiki Kaisha | Pharmaceutical composition for treating inflammatory bowel diseases |
-
2001
- 2001-09-13 CN CNB01128840XA patent/CN1281217C/zh not_active Expired - Fee Related
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2002
- 2002-09-09 WO PCT/CN2002/000630 patent/WO2003022292A1/zh active Application Filing
- 2002-09-09 AT AT02754173T patent/ATE428432T1/de not_active IP Right Cessation
- 2002-09-09 US US10/489,505 patent/US20040265299A1/en not_active Abandoned
- 2002-09-09 EP EP02754173A patent/EP1437140B1/en not_active Expired - Lifetime
- 2002-09-09 DE DE60231997T patent/DE60231997D1/de not_active Expired - Lifetime
- 2002-09-09 ES ES02754173T patent/ES2322041T3/es not_active Expired - Lifetime
- 2002-09-09 JP JP2003526420A patent/JP2005524604A/ja active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| JP2005524604A (ja) | 2005-08-18 |
| ATE428432T1 (de) | 2009-05-15 |
| CN1406587A (zh) | 2003-04-02 |
| ES2322041T3 (es) | 2009-06-16 |
| DE60231997D1 (de) | 2009-05-28 |
| EP1437140B1 (en) | 2009-04-15 |
| WO2003022292A1 (fr) | 2003-03-20 |
| EP1437140A4 (en) | 2005-06-22 |
| US20040265299A1 (en) | 2004-12-30 |
| EP1437140A1 (en) | 2004-07-14 |
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