CN85109551A - 制备萨克拉尔混悬剂 - Google Patents

制备萨克拉尔混悬剂 Download PDF

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CN85109551A
CN85109551A CN198585109551A CN85109551A CN85109551A CN 85109551 A CN85109551 A CN 85109551A CN 198585109551 A CN198585109551 A CN 198585109551A CN 85109551 A CN85109551 A CN 85109551A CN 85109551 A CN85109551 A CN 85109551A
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sucralfate
fitow
suspensoid
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尤尔里克·翰斯坦
洛瑟·巴俄
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K9/00—Medicinal preparations characterised by special physical form
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants

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Abstract

本发明涉及含萨克拉尔菲特(Sucralfate)的混悬剂，其特征是它们含重量为萨克拉尔菲特(Sucralfate)的重量的1～5％的苍耳(Xanthan)胶和1～12.5％的至少一种胶溶剂。

Description

本发明涉及含萨克拉尔菲特（Sucralfate）有效成分的混悬剂药物配方。萨克拉尔菲特〔Sucralfate    Culcogent（R），〕是一种碱式蔗糖硫盐铅。在德国公开说明书1，568，346中已作过叙述。它可作人用药，用于缓解胃及十二指肠溃疡症状和加速溃疡愈合。此外，在德国专利申请书P3，322，078中还提到它可作兽药，用于牲畜止吐和/或止泻。
萨克拉尔菲特（Sucralfate）的作用特点是它具有结合胃蛋酶和抗酸作用，且耐受性好。它是在消化道的酸性介质中（特别是在PH4下）起作用的，并在胃及十二指肠粘膜上涂上一层保护膜。结果由于它具有与受侵蚀粘膜优先结合的亲力，所以能加强粘膜保护和加速溃疡愈合以及使粘膜再生和恢复功能。
迄今含萨克拉尔菲特（Sucralfate）的制剂仅有固体剂型，如片剂、颗粒或粉末。然而，液体配方如混悬剂，对于萨克拉尔菲特（Sucralfate）特殊的作用模式可能有利，尤其是考虑到消化道粘膜的迅速而完全的覆盖，也确定有可能将市售的固体制剂分散混悬于液体介质如水中服用。但经验证明。这并不理想，并且常常带有不愉快的味道，因而实用意义不大。迄今为将含萨克拉尔菲特（Sucral-fate）的成药配成混悬剂的尝试都失败了。因为没有一种采用常用辅料配成的混悬液能放置一段时间后还能保持稳定。这些混悬剂在放置短时间后，固体即沉降并形成硬块，有时即使振摇也不能使它分散。
本发明旨在找出一种使含萨克拉尔菲特（Sucralfate）混悬剂稳定的方法，并且这种稳定的配方可作成药用。
为了配好这种混悬剂，尝试过加入适宜的添加剂来防止混悬颗粒沉降，或至少尽可能不发生沉积，即保证药剂保持均相，即使在放置一段时间后，仍适于服用。如果在放置过程中即使出现沉积，也要保证经振摇后固体能再次分散开。此外，口服用混悬剂应尽可能味道好，或至少是无味的，特别是固体物质或固体颗粒应不给服药带来麻烦。在用水作混悬剂时。上述性质可以通过加入能增加粘度的液体如甘油丙二醇，山梨醇和/或液体聚乙二醇和加入悬浮剂以及增稠剂来达到。用于增加粘度以防止固体颗粒沉降的物质，通常是一些大分子量纤维素衍生物或多糖类凝胶，例如羧甲基纤维素、甲基纤维素、藻酸盐和黄著胶。
为了配制一种不会出现沉降的含萨克拉尔菲特（Sucralfate）稳定混悬剂曾作过许多努力，但收效甚微，为此，对药物混悬剂制造工艺中，惯用的主要悬浮剂和相应的辅料及添加物都曾作过试验。发现显然由于萨克拉尔菲特（Sucralfate）在水溶液中能释放出AD3离子，所以它能与实际上所有的增稠剂产生相互作用，结果有时会导致粘度急剧减少或增加，并能使增稠剂沉淀。这意味着在混悬配方中萨克拉尔菲特（Sucralfate）颗粒会迅速沉降，形成块状沉淀沉积并粘结在包装容器的器壁上，再也不能振摇分散。
此外，又意外地发现，如果在含萨克拉尔菲特（Sucralfate）的混悬剂配方中加入重量为萨克拉尔菲特（Sucralfate）含量1～5%的苍耳（Xanfhan）胶和1～12.5%的至少一种胶溶剂，就可以得到稳定的制剂。
因此，本发明相应地涉及一种含萨克拉尔菲特（SUcralfate）的混悬剂，其中含有重量为Sucralfate）含量1-5%的苍耳（Xanfhan）胶和1-12.5%的至少一种胶溶剂。
本发明特别涉及这样一种配方，即其中所含胶溶剂为至少一种磷酸和/或柠檬酸的盐。
此外，本发明还涉及一种制备这种含萨克拉尔菲特（Sucralfate的稳定混悬剂的方法。此混悬剂还含重量为萨克拉尔菲特（Sucralfate）含量1-5%的苍耳（Xanthan）胶和1-12.5%的至少一种胶溶剂。
苍耳（Xanthan）胶是一种高分子多糖，可从碳水化合物与假单胞菌类微生物，特别是野油菜黄单胞菌（甘蓝黑腐病黄单胞菌）（Xanthomonas    Campestris）发酵制备。通常制成碱金属和/或碱土金属盐。众所周知，苍耳（Xanthan）胶也可用作药品和化妆品的悬浮剂和增稠剂（HP    Fiedler，Lexikon    der    Hilfsstoffe（Lexicon    of    Auxiliaries），Page    1016，2nd    edition（1981）或美国药典第20修订版（1980）。所以，例如苍耳Xanfhan胶的铝盐也可用作药物的赋形剂以及用作为X-线造影剂硫酸钡的悬浮剂（参见CA79（1973）23582m和81（1973）96461x）。
另一方面，苍耳（Xan    han）胶也用作金属氧化物、氢氧化物、碳酸盐，特别是铝混悬液的絮凝剂（CA    94（1981）52786w，95（1981）12692b和96（1982）247262）。从上所述，并不能因此认为苍耳（Xanthan）胶全都适用于稳化含萨克拉尔菲特（Suc-ralfate）的混悬剂。相反，在许多实验中发现用苍耳（Xanthan）胶并不容易满意地解决问题，这和用所有其它的增稠剂一样，即使与其它在药物混悬剂制造工艺中常用的辅料和添加剂合并使用时也如此。
结果导致了一种含药物萨克拉尔菲特（Sucralfate），增稠剂苍耳（Xanthan）胶和至少一种胶溶剂的稳定混悬制剂的产生。如果按本发明的要求选择组分的数量，则这种混悬剂能满足制剂和药用的要求，效果格外令人满意。
根据本发明，用于制备萨克拉尔菲特（Sucralfate）混悬剂的萨克拉尔菲特（Sucralfate）是常用的有效药物成分。这里所用的萨克拉尔菲特（Sucralfate）最好是研细的粉末，颗粒直径要小于50微米。
根据本发明，用作悬浮剂和增稠剂的苍耳（Xanthan）胶，可以用发酵过程工业规模制备，并有商品供应，质量符合各国药典规格。
根据本发明，加入混悬剂的胶溶剂是无机盐或有机盐。主要是保证大分子量苍耳（Xanthan）胶添加剂保持溶胶状态，即在分散系统中（如本混悬剂）保持均匀分布，通过生成凝胶而不会分层。这些胶溶剂，例如可以是可供药用的磷酸柠檬酸或其它三元酸的盐。这里最适用的是磷酸和柠檬酸盐，最好用磷酸二氢钠。
根据本发明，在混悬剂中加入重量为萨克拉尔菲特（Sucral-fate）含量1-5%的苍耳（Xanthan）胶和1-12.5%的至少一种胶溶剂，以有效地保持混悬剂持久的稳定性。在这些配方中，萨克拉尔菲特（Sucralfate）的含量可以在一个较宽的范围内变化。
通常，这种混悬剂可含占总量1-40%的萨克拉尔菲特（Suc-rafate）。根据本发明，典型的萨克拉尔菲特（Sucrafate）混悬剂配方含占总量1-40%（重量），最好为10-25%（重量）的萨克拉尔菲特（Sucralfate），0.01-2%（重量），最好为0.1-1%（重量）的苍耳（Xanthan）胶和0.01-5%（重量），最好为0.1-3%（重量）的胶溶剂。除了可用水作为液体介质外，根据本发明还可用能增加粘度的液体如甘油和丙二醇，其数量为1-50%（重量），最好为10-20%（重量）。此外，也可以加入在药物混悬剂制备工艺中常用的其它辅料和添加剂。主要包括防腐剂如甲基-4-羟基苯甲酸钠和丙基-4-羟基苯甲酸钠，可以合用也可以单用，其常用浓度为，例如0.1%（重量）。也可以加入调味香料，甜味剂和矫味剂。通常，这类添加剂的添加数量很少超过总量的1%。根据本发明，也可以在萨克拉尔菲特（Sucral-fate）混悬剂中加入其它的有效成分，如已知能和萨克拉尔菲特（Sucralfate）配伍的药物如抗酸药，解痉药，排气药，H2-受体阻滞剂，非甾体抗炎药和抑制酸泌的药物。还包括在欧洲专利AL-0.107，209中提到的氨基酸，它们能增强萨克拉尔菲特（Suc-ralfate）覆盖粘膜的作用或在恶劣的贮存条件下使产品的效果保持不变。
根据本发明，萨克拉尔菲特（Sucralfate）混悬剂可按已知的方法，将组分混合和均化来制备，并可用药物混悬剂常用的包装方法灌装，如用瓶，大安瓿或供口服或直肠给药用的分剂量包装（Por-tion    Pack）。有效成分在任何长时间的贮存期内能保持混悬状态，不会出现不能再分散的沉积，不会结块或粘结在容器壁上。
根据本发明，萨克拉尔菲特（Sucralfate）混悬剂的医用范围与已知的萨克拉尔菲特（Sucralfate）制剂相同。特别适用于人消化道受侵蚀粘膜的保护和愈合，尤其是用于胃及十二指肠溃疡症状的缓解和使溃疡愈合。但此药也可供兽用，以止吐和/或止泻。根据治疗要求，混悬剂通常用口服给药，剂量与已知的萨克拉尔菲特（Sucralfate）制剂相同。如合适也可以直肠给药。根据本发明，这种给药方式是这种萨克拉尔菲特（Sucralfate）混悬剂的一大优点，因为这种使用方式是以前已知的剂型所实际上不能达到的。
实施例1
5ml20%（重量）萨克拉尔菲特（Sucralfate）口服混悬剂含：
萨克拉尔菲特（Sucralfate）    1.118克
NaH2PO40.03克
苍耳（Xanthan）胶    0.02克
甘油    5.00克
甲基-4-羟基苯甲酸钠    0.0025克
矫味剂    适量
水    加至5.0毫升
实施例2
100    10%（重量）萨克拉尔菲特（Sucralfate）直肠给药用混悬剂含：
萨克拉尔菲特（Sucralfate）    11.18克
NaHPO40.40克
苍耳（Xanthan）胶    0.19克
甘油    10.00克
甲基-4-羟基苯甲酸钠    0.05克
丙基-4-羟基苯甲酸钠    0.05克
水    加至100毫克

Claims (1)

  1. 使萨克拉尔菲特(Sucralfate)的药物混悬剂稳定的配制方法，其特征是在这些配方中加入重量为萨克拉尔菲特(Sucralfate)含量1～5%的苍耳(Xanthan)胶和1～12.5%的胶溶剂。
CN198585109551A 1984-08-22 1985-11-15 制备萨克拉尔混悬剂 Pending CN85109551A (zh)

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DE19843430809 DE3430809A1 (de) 1984-08-22 1984-08-22 Sucralfat-suspension

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CN85109551A true CN85109551A (zh) 1987-05-20

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US4885281A (en) 1989-12-05
DE3430809A1 (de) 1986-03-06
NZ213185A (en) 1988-03-30
ES537578A0 (es) 1986-01-01
AU567257B2 (en) 1987-11-12
ATE41308T1 (de) 1989-04-15
FI861674A0 (fi) 1986-04-21
SG35889G (en) 1989-10-13
IL76138A (en) 1989-09-28
NO170126C (no) 1992-09-16
IE58201B1 (en) 1993-07-28
CA1236773A (en) 1988-05-17
FI80592B (fi) 1990-03-30
FI80592C (fi) 1990-07-10
IL76138A0 (en) 1985-12-31
IN164763B (zh) 1989-05-27
PH21250A (en) 1987-08-31
AU3438284A (en) 1986-03-24
DK183386A (da) 1986-04-21
HK62889A (en) 1989-08-11
DK164479B (da) 1992-07-06
IE852058L (en) 1986-02-22
WO1986001406A1 (en) 1986-03-13
EP0192640A1 (de) 1986-09-03
JPS61503031A (ja) 1986-12-25
ZA848884B (en) 1985-07-31
DK164479C (da) 1992-11-16
IT8449164A1 (it) 1986-05-14
NO861545L (no) 1986-04-18
FI861674A (fi) 1986-04-21
DK183386D0 (da) 1986-04-21
GR852023B (zh) 1985-12-16
SU1544173A3 (ru) 1990-02-15
PT79610A (en) 1985-01-01
JPH0535130B2 (zh) 1993-05-25
IT8449164A0 (it) 1984-11-14
EP0192640B1 (de) 1989-03-15
IT1178235B (it) 1987-09-09
ES8607727A1 (es) 1986-01-01
DE3477138D1 (en) 1989-04-20
NO170126B (no) 1992-06-09

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