CN1329923A - 治疗小儿腹泻浓缩颗粒及其制备工艺 - Google Patents
治疗小儿腹泻浓缩颗粒及其制备工艺 Download PDFInfo
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Abstract
本发明治疗小儿腹泻浓缩颗粒及其制备工艺提供了专治小儿腹泻的药品,本药剂由多种酶,次碳酸铋、叶酸等十种药物和辅料制成、制备治疗小儿腹泻浓缩颗料的工艺,大致可分为糖浆调配、软材制粒、热风干燥、称量包装等工艺流程、该成药制剂备组方配比科学合理、至补作用明显、成本低、制备工艺科学,服用简便,治疗期短,疗效高,对小儿口炎性腹泻有特效。
Description
本发明治疗小儿腹泻浓缩颗粒及其制备工艺属专门治疗小儿腹胀、肠炎、肠功能絮乱及消化不良引起的腹泻药品及其制备工艺，尤其涉及一种治疗小儿腹泻新药配方浓缩颗粒及其制备工艺。
目前国内制药企业生产专治小儿腹泻的制剂很少，市场销售治疗小儿腹泻药品配方陈旧，多为片剂和水剂，用量标明不具体，幼儿服用不便，效果不明显。
本发明治疗小儿腹泻浓缩颗粒及其制备工艺给患有腹泻儿童提供了配方合理、各组方互补作用显著的新药剂。制备治疗小儿腹泻浓缩颗粒不仅工艺科学简便，而且制备工艺中强调了严格控制操作室湿度和药剂干燥时温度的规范标准，又注意了药剂PH值的规范要求，保证了多种酶成分活力和其他盐类结晶体的稳定性，使各药成分合理结合、配合治疗，达到了胃肠同治，标本同治、药力迅速、直达病所、疗效显著、成本低廉、无毒副作用。使小儿胃部和肠部积留的可溶性淀粉、凝固的卵蛋白和酪蛋白完全消化和转化，迅速治愈小儿腹泻，使小儿胃肠恢复正常的消化功能。
为了实现上述发明目的，其治疗小儿腹泻浓缩颗粒及其制备工艺如下所述：
1、治疗小儿腹泻浓缩颗粒由胰酶、胃蛋白酶、淀粉酶、次碳酸铋、醋酸甲萘氢醌、叶酸、白蔗糖粉、糖浆、淀粉和食用色素组方组成。治疗小儿腹泻浓缩颗粒各组方有效组方量、有效百分比含量如下表所示：
| 药名 | 胰酶 | 胃蛋白酶 | 淀粉酶 | 次碳酸铋 | 醋酸甲萘氢醌 | 叶酸 | 白蔗糖 | 糖浆50％ | 淀粉 | 食用色素 | 合计 |
| 配方量(克) | 1200 | 400 | 1200 | 3000 | 20 | 50 | 1000 | 2300 | 500 | 330 | 10000 |
| 含量(％) | 12.0 | 4.0 | 12.0 | 30.0 | 0.2 | 0.5 | 10.0 | 23.0 | 5.0 | 3.3 | 100 |
2、治疗小儿腹泻浓缩颗粒的制备工艺如下所述：
(1)将组方各药分别称量备齐，固体药分别过80目筛备用。
(2)除糖浆外，将各组方成分按有效组方量配齐在摇摆式制粒机中干混10分钟均匀后加入定量糖浆制成软材。
(3)将软材用18目筛网制粒，并经45℃以下热风循环干燥至含水量2％以下，分装成12克小袋为成药。
(4)为了稳定酶活，在制作时要注意室间湿度控制在65％以内，干燥时温度不能超过45℃。
(5)为了使叶酸保持稳定，在制作时软材PH值必须掌握在6.0—9.8之间，必要时可增减次碳酸铋使软材PH值得到调整。
治疗小儿腹泻浓缩颗粒服用方法：6个月以内小儿，一天三次，每次4克，温开水冲服；6个月至1岁小儿，一天三次，每次6克，温开水冲服；1-2岁，一天三次，每次12克，温开水冲服；3岁以上，一天三次，每次24克，温开水冲服。
腹泻是小儿常见病，是由于小儿饮食不当、饥饱无常或食用变质不洁食物后引起消化不良，使淀粉粘附胃肠，卵蛋白在胃肠中凝固，酪蛋白停止转化，刺激肠功能絮乱，肠蠕动加快，水份及营养不能吸收，直接排出小儿体外。小儿腹胀和大便如水为本病主要临床表现。本药组方中胰酶、淀粉酶和胃蛋白酶，具有帮助消化功能，其中淀粉酶能使可溶性淀粉完全消化，胃蛋白酶能使凝固的卵蛋白完全消化，胰酶能使酪蛋白迅速转化为胨被吸收。叶酸有补血、造血和消炎杀菌功能，对小儿口炎性腹泻有特效。次碳酸铋为组成不定的铋的硷式碳酸盐，对肠胃粘膜有收敛和保护作用，能使小儿腹胀后胃肠功能絮乱迅速恢复正常。醋酸甲萘氢醌能参与肝内凝血，可以预防小儿肠胃发炎后出血，并有松驰肠道平滑肌、解除痉挛、促进水分吸收的作用，从而达到止泻的目的。白蔗糖、糖浆和淀粉不仅为本药粘合物，而且可使药物改良苦性，增加小儿喜食性。
现代药理证明，以上各药合用，小儿口服后，药物即直接进入胃肠器管各药功能互补，使胃肠中积存和粘附的食物体迅速得到消化，粘液中的病菌迅速被杀灭，粘膜得到收敛、扑充和保护，使腹泻停止，小儿胃肠功能和大便恢复正常。
治疗小儿腹泻浓缩颗粒组方经长期临床应用和不断改进，选用诸药在糖浆中混配，其有效成分集中一体，形成均匀粘结颗粒，配伍合理，小儿口服后互补作用显著，可治疗小儿腹泻，特别是治疗肠炎、肠功能絮乱及消化不良引起的小儿腹泻病症，使用方便，效果明显，有效率达100％，治愈率达95％，本小儿口服治疗腹泻浓缩颗粒成本低廉，疗效高、无毒副作用，对小儿口炎性腹泻有特效。
Claims (2)
1、本发明治疗小儿腹泻浓缩颗粒及其制备工艺其特征在于治疗小儿腹泻浓缩颗粒由三种酶、次碳酸铋、醋酸甲萘氢醌、叶酸及白蔗糖、糖浆、淀粉和食用色素十种药料组方组成，制备治疗小儿腹泻浓缩颗粒的工艺如下所述：先将各种药物和辅料分别称量备齐，在摇摆式制粒机中干混10分钟后加入糖浆制成软材，将软材用14目筛网制粒后经45℃以下热风循环干燥，使含水量低于2％后，分装成袋，每袋重12克。
2、如权利要求1所述的治疗小儿腹泻浓缩颗粒及其制备工艺，其特征在于治疗小儿腹泻浓缩颗粒各组方有效百分比含量如下：胰 酶 12.0 胃蛋白酶 4.0 淀粉酶 12.0 次碳酸铋 30.0醋酸甲萘氢醌 0.2 叶 酸 0.5 白蔗糖 10.0 糖 浆 23.0淀 粉 5.0 食用色素 3.3
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