CN1139379A - 制备栓剂的新方法 - Google Patents
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Abstract
本发明涉及药物技术领域。更具体地说,本发明涉及能释放二氧化碳并具有缓泻作用的栓剂的制备方法,其中脂肪物质单独熔化,将植物卵磷脂加入到熔化后得到的液体中,然后掺入无机遮光剂,然后边搅拌边倾入酒石酸钾和碳酸氢钠,这两种成分具有特定的粒度,然后连续搅拌直至达到完全均匀,然后放出该液体悬浮液。申请保护保存稳定泡腾栓剂的制备。
Description
本发明涉及药物技术领域。
更具体地说涉及制备栓剂并且特别是具有缓泻作用的栓剂的新方法。
具体地说,本发明主题是制备具有缓泻作用的栓剂的方法,所述栓剂通过与直肠壶腹中存在的水分接触,其中活性组分发生化学反应而能够释放出二氧化碳。
法国专利n°788,198(Waldenmeyer J.G)公开了一种方法,该方法可以在水分作用下或因其他原因释放出初生态的二氧化碳,并且其中通过混合而释放出该酸的各原料各自被包裹于脂肪物质中,脂肪物质可保护它们避免过早分解,但可使得它们在使用时通过一种亲水剂的催化作用而互相接触。
阅读该专利可推测这可能涉及一种制备释放二氧化碳的栓剂的方法,但没有对该主题进行描述,并且仅仅是脂肪物质例如可可油的使用才可能使人想到这样的用途。
随后在市场上出现了利用该方法制备的药物制剂。形成了一种含有酒石酸钾和碳酸氢钠的泡腾混合物的栓剂,在湿润环境下该栓剂可在直肠中释放约50ml-100ml的二氧化碳。
研制该药物制剂时的问题是难于制得这样的产物,即在生产期间或生产之后不久不会过早地反应,而能够保持完全的泡腾特性的产物。
因此该方法本身遭遇到两个问题。活性组分由于显著亲脂性、绝对密固的阻隔物作用而实际相互分离。由于阻隔物密固性的缘故,该药物制剂能够保存完好,但这样一来活性组分不能互相反应,结果药物制剂实际是非活性的。
另一方面,如果活性组分不是包裹于不能渗透的基质中,则它们易于在所提供的包装材料中过早地相互反应,特别是它们能够在直肠壶腹中相互之间过多强烈地反应,并激发直肠壶腹太强烈地扩张。
因此找到一种具有充分隔离特性的包膜材料,以阻止泡腾混合物的组成成分相互之间过早反应,但能够在与有或多或少水分的粘膜例如直肠壶腹接触时导致二氧化碳有规律地、不断地、逐渐释放是十分重要的。
采用本发明方法可以达到该目的。
在本方法中,将脂肪物质单独熔化,将混合物放置冷却至所需的温度,并将植物卵磷脂分散到经熔化得到的液体物质中,然后掺入无机遮光剂,随后在搅拌下紧接着连续倒入酒石酸钾,然后在更剧烈搅拌下倒入碳酸氢钠,其中这两种成分具有特定的粒度,然后继续搅拌直到达到完全均匀,然后将液体悬浮液倒入栓剂小泡中。
冷却之后,获得了具有经过规定截头的锥体形状的栓剂,其组成成分均匀,并且通过检测到的二氧化碳释放量证实其保存期至少为2年。
因此可清楚地看到所要解决的技术问题与Waldenmeyer方法考虑的显著不同,同时,脂肪物质组成一个密固包膜,该包膜可完全地、甚至很完全地防止亲水剂的催化作用,有必要在其中掺入一种有利于含水介质传递的产品。
相反,在本发明技术中,制备栓剂所用赋形剂用具有中等链的聚乙二醇硬脂酸酯或者脂肪酸甘油三脂制备,它们是亲脂性同时又是亲水性的物质,所以必须利用惰性保护屏障而不再是用类脂物质来保护混合物的反应活性物质。
在本发明方法的优选实施例中,用作栓剂的载体的脂肪物质是具有中等链的脂肪酸甘油三脂,其商品名为HENKEL公司的Novata BD。也可以使用由UNICHEMA公司的商品名为Estaram H 15,或者GATTEFOSSE公司的商品Suppocire AM,或者HULS公司的商品Witepsol H 15。这些甘油三脂的熔点范围为35-39℃。
所述植物卵磷脂是一种大豆卵磷脂,并且特别是由LUCAS MEYER公司销售的商品名为Topcithin 50的种类或者由同一公司销售的商品名为MC Thin AF1的种类。卵磷脂可以避免或者降低混合物在倾倒之前增稠,并且用于部分溶解的固体活性组分的情况中,或者特别是用于活性组分为粉末的情况下。根据环境不同,可将卵磷脂溶于脂肪物质中或者相反地,保持悬浮液状态。
所述遮光剂是天然或合成硅酸盐,例如滑石或者硅酸镁,或者是碱土金属硬脂酸盐,例如硬脂酸钙或硬脂酸镁,或者钛衍生物,例如二氧化钛,或者一种钡衍生物例如钛酸钡。
按下列方式调节泡腾混合物的各组成成分(酒石酸钾和碳酸氢钠)的粒度:所述方式为使粉末具有良好精细度,并且在前面所述制备过程中在搅拌下以充分均匀的方式使粉末分散而不沉降。
在倾至小泡中之后,通过冷却逐渐地降低栓剂的温度直到完全固化。
由此制备的栓剂其货架寿命期为2年,这样确保其保存期至少为相同的时间。
下列实施例描述发明,但不限制它。
实施例1
泡腾栓剂的制备
将36.7kg固体的半合成甘油酯加入到不锈钢容器中,并在35-39℃之间的温度下熔化。然后在搅拌下加入4.2kg大豆卵磷脂。然后仍在搅拌下逐渐掺入2.1kg滑石。在悬浮液均匀之后,剧烈搅拌下以少量分批加入23kg酒石酸钾,然后加入14kg碳酸氢钠。
将这些成分搅拌混合10分钟,然后在保持温度情况下,取出悬浮液,充填到小泡中,并送入到密闭的冷却室中直至完全固化。
栓剂泡腾性的测定:
原理:
通过于37℃检测二氧化碳气的释放而监测泡腾特性。
技术:
于37℃将栓剂快速导入到填充了水的试管A(100ml)中,用备有橡皮接头的多孔玻璃塞子(孔隙度为2)封闭试管,同时确保管中不留有气泡。
于37℃将试管A浸于填充了水的第二个试管B(250ml)中,并且试管B中有一个磁棒。将试管B置于约40℃水浴中,水浴放在一个磁性加热搅拌器上,以保持温度(37℃±1℃)不变。
在整个气体释放过程中,保持磁性搅拌和加热。读出试管A的二氧化碳体积。
泡腾栓剂稳定性的检测以及释放的二氧化碳剂量的检测。
泡腾栓剂的检测用三个不同时间生产的几个生产批次进行。
进行下列检测:
·在生产起始、生产中间或生产结束时的单个泡上检测,和
·在生产开始、生产中间或生产结束时的几个泡上检测。
这些检测可说明:
·在生产期间(开始、中间或结束)的给定时刻获取的单个泡中,释放出的二氧化碳体积的最大差异,和因此确定的泡内均匀性:
·在生产期间(开始、中间或结束)的不同时刻获取的几个泡中,释放出的二氧化碳体积的最大差异,和因此而确定的泡内均匀性。
·在生产开始、中间以及结束时释放的二氧化碳的平均体积。
·释放出的二氧化碳的平均总体积。
所有这些检测是在250ml试管中完成。
结论如下所示:
平均气体释放量是50和100ml。
生产的一批产品在时间为0时与前两年生产的一批产品之间释放的二氧化碳的体积没有显著减少。
在大多数情况下,在生产中期时获得最大的气体释放量;在大多数情况下,在生产结束时得到最坏的气体释放量。
更具体地说,所完成的检测产生下列结果:
生产 起始 10小时 12小时 14小时 结束
泡腾剂 批号1 批号2 批号3 批号4 批号5
检测n°1 94ml 80ml 80ml 76ml 76ml
检测n°2 91ml 84ml 86ml 82ml 80ml
检测n°3 93ml 73ml 84ml 80ml 78ml
总之,记录下的差异考虑了难于获得完全均匀的制剂,并且同时考虑了由于二氧化碳溶于水而导致气体释放量检测方法的灵敏度不确定性。
Claims (8)
1.一种制备栓剂的方法,所述栓剂在与水分接触时,可通过反应活性混合物的化学反应而导致释放二氧化碳气,其特征在于将栓剂的赋形剂单独熔化,将混合物冷却到所需温度,将卵磷脂掺入其中,然后加入无机遮光剂,再依次加入产生二氧化碳的成分,将该液体悬浮液倒入小泡中。
2.根据权利要求1的制备具有泡腾作用的栓剂的方法,其特征在于赋形剂是脂肪物质,其熔点在35和39℃之间,并且其中掺入酸性钾盐和碱性碳酸氢盐作为产生二氧化碳气的成分。
3.根据权利要求1或2的方法,其特征在于向栓剂的赋形剂中加入酒石酸钾;然后加入碳酸氢钠,这两种组成成分具有特定的粒度。
4.根据权利要求1至3之一的制备具有泡腾作用的栓剂的方法,其特征在于所用的脂肪物质是具有中等链的聚乙二醇硬脂酸酯或脂肪酸甘油三酯。
5.根据权利要求1至4之一的方法,其特征在于将具有中等链的脂肪酸甘油三酯用作脂肪物质。
6.根据权利要求1至4之一的方法,其特征在于用作赋形剂的具有中等链的脂肪酸甘油三酯是那些熔点为35-39℃的脂肪酸甘油三酯。
7.根据权利要求1的方法,其特征在于植物卵磷脂是大豆卵磷脂。
8.根据权利要求1的方法,其特征在于遮光剂是一种天然或合成硅酸盐,或者是一种碱土金属硬脂酸盐、硬脂酸镁或二氧化钛或一种不溶性钛酸盐。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
FR94/11913 | 1994-10-05 | ||
FR9411913A FR2725371B1 (fr) | 1994-10-05 | 1994-10-05 | Nouveau procede de fabrication de suppositoires |
Publications (2)
Publication Number | Publication Date |
---|---|
CN1139379A true CN1139379A (zh) | 1997-01-01 |
CN1303983C CN1303983C (zh) | 2007-03-14 |
Family
ID=9467597
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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CNB951913565A Expired - Fee Related CN1303983C (zh) | 1994-10-05 | 1995-10-05 | 制备栓剂的新方法 |
Country Status (13)
Country | Link |
---|---|
US (1) | US6033683A (zh) |
EP (1) | EP0741564B1 (zh) |
KR (1) | KR100384323B1 (zh) |
CN (1) | CN1303983C (zh) |
AT (1) | ATE322248T1 (zh) |
BR (1) | BR9506439A (zh) |
DE (1) | DE69534916T2 (zh) |
FI (1) | FI119140B (zh) |
FR (1) | FR2725371B1 (zh) |
MX (1) | MX9602121A (zh) |
NO (1) | NO317933B1 (zh) |
PL (1) | PL183374B1 (zh) |
WO (1) | WO1996010987A1 (zh) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
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CN105670003A (zh) * | 2014-11-21 | 2016-06-15 | 常州坤宇环保科技有限公司 | 高吸水树脂防结块剂 |
Families Citing this family (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CA2365905A1 (en) * | 1999-04-09 | 2000-10-19 | Human Genome Sciences, Inc. | 48 human secreted proteins |
GB0818336D0 (en) * | 2008-10-07 | 2008-11-12 | Cosmetic Warriors Ltd | Composition |
Family Cites Families (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
FR788198A (fr) * | 1934-12-18 | 1935-10-05 | Procédé pour la fabrication de préparations thérapeutiques dégageant de l'acide carbonique | |
FR5391M (zh) * | 1965-11-04 | 1967-10-23 | ||
US3764668A (en) * | 1970-09-30 | 1973-10-09 | Interx Research Corp | Compositions of salts of salicylamide |
JPS55136215A (en) * | 1979-04-10 | 1980-10-23 | Res Inst For Prod Dev | Preparation of laminar laxative suppository |
JPS5683417A (en) * | 1979-12-11 | 1981-07-08 | Kanae:Kk | Preparation of layer laxative suppository |
JPS58152809A (ja) * | 1982-03-05 | 1983-09-10 | Eisai Co Ltd | 安定な発泡性「膣」坐剤 |
IT1213464B (it) * | 1986-07-25 | 1989-12-20 | Riccardo Casero | Forma farmaceutica per la somministrazione enterica di acido etodolico o di suoi sali, in miscela con eccipienti. |
US5547976A (en) * | 1992-03-20 | 1996-08-20 | Burroughs Wellcome Co. | Further indole derivatives with antiviral activity |
-
1994
- 1994-10-05 FR FR9411913A patent/FR2725371B1/fr not_active Expired - Fee Related
-
1995
- 1995-10-05 BR BR9506439A patent/BR9506439A/pt not_active Application Discontinuation
- 1995-10-05 PL PL95314835A patent/PL183374B1/pl unknown
- 1995-10-05 EP EP95934170A patent/EP0741564B1/fr not_active Expired - Lifetime
- 1995-10-05 US US08/666,543 patent/US6033683A/en not_active Expired - Lifetime
- 1995-10-05 DE DE69534916T patent/DE69534916T2/de not_active Expired - Lifetime
- 1995-10-05 MX MX9602121A patent/MX9602121A/es unknown
- 1995-10-05 CN CNB951913565A patent/CN1303983C/zh not_active Expired - Fee Related
- 1995-10-05 WO PCT/FR1995/001294 patent/WO1996010987A1/fr active IP Right Grant
- 1995-10-05 AT AT95934170T patent/ATE322248T1/de not_active IP Right Cessation
- 1995-10-05 KR KR1019960702930A patent/KR100384323B1/ko not_active IP Right Cessation
-
1996
- 1996-06-04 FI FI962328A patent/FI119140B/fi not_active IP Right Cessation
- 1996-06-04 NO NO19962297A patent/NO317933B1/no not_active IP Right Cessation
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN105670003A (zh) * | 2014-11-21 | 2016-06-15 | 常州坤宇环保科技有限公司 | 高吸水树脂防结块剂 |
Also Published As
Publication number | Publication date |
---|---|
US6033683A (en) | 2000-03-07 |
KR100384323B1 (ko) | 2003-11-28 |
FI119140B (fi) | 2008-08-15 |
NO962297D0 (no) | 1996-06-04 |
BR9506439A (pt) | 1997-09-02 |
ATE322248T1 (de) | 2006-04-15 |
MX9602121A (es) | 1997-07-31 |
FR2725371B1 (fr) | 1997-08-29 |
DE69534916T2 (de) | 2007-03-08 |
CN1303983C (zh) | 2007-03-14 |
EP0741564B1 (fr) | 2006-04-05 |
PL183374B1 (pl) | 2002-06-28 |
DE69534916D1 (de) | 2006-05-18 |
PL314835A1 (en) | 1996-09-30 |
FR2725371A1 (fr) | 1996-04-12 |
WO1996010987A1 (fr) | 1996-04-18 |
KR960706324A (ko) | 1996-12-09 |
NO317933B1 (no) | 2005-01-10 |
EP0741564A1 (fr) | 1996-11-13 |
FI962328A0 (fi) | 1996-06-04 |
FI962328A (fi) | 1996-06-04 |
NO962297L (no) | 1996-06-04 |
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