CN112618704A - 一种胆结石药品制剂及其制备方法 - Google Patents
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Abstract
本发明涉及属于医药制剂技术领域，尤其为一种胆结石药品制剂，包括阿嗪米特、胰酶、二甲硅油、金钱草、郁金、枳壳、白芍、黄芪和石韦，本发明通过采用利胆药物的阿嗪米特为主，主促进我们的胆汁分泌的药物，以及胰酶、二甲硅油并且与治疗胆结石的中药物组合物，组成了一个复方的固定制剂，能够对胆汁分泌不足，消化不良的患者，促进胆汁的排泌，促进脂肪类食物的吸收，消化，等等，还有二甲基硅油，对于气体过多的话，它会有一定的干预，对于我们这种胆汁分泌不足，引起的消化不良的患者，有比较好的作用，从而达到其配方合理，具有舒肝利胆，行气止痛功能，对肝胆内管结石，胆结石病症治疗，排石效果好，见效快的效果。
Description
技术领域
本发明涉及医药制剂技术领域，尤其涉及一种胆结石药品制剂及其制备方法。
背景技术
随着社会生活水平的提高，生活节奏的加快，胆囊炎、胆结石病的发生率呈上升趋势，并且多发生于35-55岁的中年人，属于中医学“胁痛”、“腹胀”、“胆胀”、“黄疸”等疾病的范畴，中医学认为其发病的是因情志不调饮食不节，湿热内生蕴结不散所致，病卫主要在肝胆，涉及脾、胃、大肠，主要病机为肝胆失疏，湿热内蕴，肝胃不和，胆汁排泄不畅，结石阻塞，胆腑不通，其病理产物形成胆结石，胆结石又称胆石症，是指胆道系统包括胆囊或胆管内发生结石的疾病；胆道感染是属于常见的疾病，按发病部位分为胆囊炎和胆管炎，结石在胆囊内形成后，可刺激胆囊黏膜，不仅可引起胆囊的慢性炎症，而且当结石嵌顿在胆囊颈部或胆囊管后，还可以引起继发感染，导致胆囊的急性炎症，由于结石对胆囊黏膜的慢性刺激，还可能导致胆囊癌的发生，有报告此种胆囊癌的发生率可达1％～2％，目前前治疗胆结石的排石疗法，排石效果差，病人要长期忍受疾病折磨。
综上所述，本发明通过设计一种胆结石药品制剂及其制备方法来解决存在的问题。
发明内容
本发明的目的在于提供一种胆结石药品制剂及其制备方法，以解决上述背景技术中提出的问题。
为实现上述目的，本发明提供如下技术方案：
一种胆结石药品制剂，包括阿嗪米特、胰酶、二甲硅油、金钱草、郁金、枳壳、白芍、黄芪和石韦，并且各成分按照重量份比分别为：阿嗪米特14～16份、胰酶10～12份、二甲硅油30～40份、金钱草7～9份、郁金10～12份、枳壳6～8份、白芍6～8份、黄芪4～6份和石韦6～8份。
一种胆结石药品制剂的制备方法，包括以下步骤：
S1，按重量份分别称取：金钱草7～9份、郁金10～12份、枳壳6～8份、白芍6～8份、黄芪4～6份和石韦6～8份分别依次加入反应釜中，并且搅拌混合，并且按照药材与水重量比1:4加入水并且加热至60～80℃提取0.8～1h，过滤，滤液浓缩至1:1的膏状，即中药组合提取物A，备用；
S2，按重量份分别称取：阿嗪米特14～16份、胰酶10～12份，在常温下，分别依次将阿嗪米特14～16份、胰酶10～12份，加入S1中得到的中药组合提取物，搅拌混合得粘稠状物B；
S3，滴丸：滴丸机内加入二甲硅油30～40份为冷凝剂，当滴丸机油浴温度升至50～55℃时，将待滴料加入调料罐内，用1排滴盘2.5#滴头进行滴制，设定药液启动温度60～65℃，开始滴丸；
S4，沥油选丸和包装：将滴制出来的滴丸放在集丸离心机的网袋中，进行离心，待沥尽冷凝剂后，将滴丸放入方形的擦油转笼孔形中选丸，将并且选出的合格滴丸收集于双层洁净低密度聚乙烯袋内，密封、称重、检验。
优选的，所述S1中搅拌混合的搅拌速度为400～500r/min，过滤，采用400～600目滤布过滤。
优选的，所述S2中的常温为22～24℃，所述S2中搅拌混合拌速度为300～400r/min，并且持续搅拌30～40min。
优选的，所述S1中滤液浓缩至1:1的膏状即1ml膏相当于1g药材。
优选的，所述S4中离心每次离心的产品重量≤2kg，离心时间4～6分钟，离心转速600～800r/min。
与现有技术相比，本发明的有益效果是：
1、本发明中，通过采用利胆药物的阿嗪米特为主，主促进我们的胆汁分泌的药物，以及胰酶、二甲硅油并且与治疗胆结石的中药物组合物，组成了一个复方的固定制剂，能够对胆汁分泌不足，消化不良的患者，比如说有些患者有腹胀，有反酸，甚至有烧心，还有口苦这类的患者，是由于胆汁的分泌不足，造成的消化功能的改变，在补充阿嗪米特以后，促进胆汁的排泌，促进脂肪类食物的吸收，消化，等等，还有二甲基硅油，对于气体过多的话，它会有一定的干预，对于我们这种胆汁分泌不足，引起的消化不良的患者，有比较好的作用，从而达到其配方合理，具有舒肝利胆，行气止痛功能，对肝胆内管结石，胆结石病症治疗，排石效果好，见效快，疗程短的效果。
具体实施方式
下面将结合本发明实施例中，对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本发明一部分实施例，而不是全部的实施例,基于本发明中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。
本发明提供一种技术方案：
一种胆结石药品制剂，包括阿嗪米特、胰酶、二甲硅油、金钱草、郁金、枳壳、白芍、黄芪和石韦，并且各成分按照重量份比分别为：阿嗪米特14～16份、胰酶10～12份、二甲硅油30～40份、金钱草7～9份、郁金10～12份、枳壳6～8份、白芍6～8份、黄芪4～6份和石韦6～8份。
一种胆结石药品制剂的制备方法，包括以下步骤：
S1，按重量份分别称取：金钱草7～9份、郁金10～12份、枳壳6～8份、白芍6～8份、黄芪4～6份和石韦6～8份分别依次加入反应釜中，并且搅拌混合，并且按照药材与水重量比1:4加入水并且加热至60～80℃提取0.8～1h，过滤，滤液浓缩至1:1的膏状，即中药组合提取物A，备用；
S2，按重量份分别称取：阿嗪米特14～16份、胰酶10～12份，在常温下，分别依次将阿嗪米特14～16份、胰酶10～12份、二甲硅油6～8份，加入S1中得到的中药组合提取物，搅拌混合得粘稠状物B；
S3，滴丸：滴丸机内加入二甲硅油30～40份为冷凝剂，当滴丸机油浴温度升至50～55℃时，将待滴料加入调料罐内，用1排滴盘2.5#滴头进行滴制，设定药液启动温度60～65℃，开始滴丸；
S4，沥油选丸和包装：将滴制出来的滴丸放在集丸离心机的网袋中，进行离心，待沥尽冷凝剂后，将滴丸放入方形的擦油转笼孔形中选丸，将并且选出的合格滴丸收集于双层洁净低密度聚乙烯袋内，密封、称重、检验。
进一步的，所述S1中搅拌混合的搅拌速度为400～500r/min，过滤，采用400～600目滤布过滤。
进一步的，所述S2中的常温为22～24℃，所述S2中搅拌混合拌速度为300～400r/min，并且持续搅拌30～40min。
进一步的，所述S1中滤液浓缩至1:1的膏状即1ml膏相当于1g药材。
进一步的，所述S4中离心每次离心的产品重量≤2kg，离心时间4～6分钟，离心转速600～800r/min。
具体实施案例：
本发明治疗胆结石药物组合物原料的药性如下：
金钱草：甘、咸，微寒。归肝、胆、肾、膀胱经。清利湿热，通淋，消肿。用于热淋，沙淋，尿涩作痛，黄疸尿赤，痈肿疔疮，毒蛇咬伤；肝胆结石，尿路结石；
郁金：辛、苦，寒。归肝、心、肺经。行气化瘀，清心解郁，利胆退黄。用于经闭痛经,胸腹胀痛、刺痛，热病神昏，癫痫发狂，黄疸尿赤；
枳壳：苦、辛、酸，温。归脾、胃经。理气宽中，行滞消胀。用于胸胁气滞，胀满疼痛，食积不化，痰饮内停；胃下垂，脱肛，子官脱垂；
白芍：苦、酸，微寒。归肝、脾经。平肝止痛，养血调经，敛阴止汗。用于头痛眩晕，胁痛，腹痛，四肢挛痛，血虚萎黄，月经不调，自汗，盗汗；
黄芪：甘，温。归肺、脾经。补气固表，利尿托毒，排脓，敛疮生肌。用于气虚乏力，食少便溏，中气下陷，久泻脱肛，便血崩漏，表虚自汗，气虚水肿，痈疽难溃，久溃不敛，血虚痿黄，内热消渴；慢性肾炎蛋白尿，糖尿病；
石韦：石韦，其性味甘、苦，微寒。入肺、膀胱经。有利水通淋、清肺泄热等作用。能清湿热、利尿通淋、治刀伤、烫伤、脱力虚损。
实施例1：
步骤1，按重量份分别称取：金钱草8份、郁金11份、枳壳7份、白芍7份、黄芪8份和石韦7份分别依次加入反应釜中，并且以搅拌速度为400～500r/min，搅拌混合，并且按照药材与水重量比1:4加入水并且加热至60～80℃提取0.8～1h，并且通过400～600目滤布过滤，滤液浓缩至1:1的膏状，即中药组合提取物A，备用；
步骤2，按重量份分别称取：阿嗪米特14份、胰酶10份，在22～24℃下，分别依次将阿嗪米特14份、胰酶10份，加入步骤1中得到的中药组合提取物，以搅拌混合拌速度为300～400r/min，并且持续搅拌30～40min，搅拌混合得粘稠状物B；
步骤3，滴丸：滴丸机内加入二甲硅油40份为冷凝剂，当滴丸机油浴温度升至50～55℃时，将待滴料加入调料罐内，用1排滴盘2.5#滴头进行滴制，设定药液启动温度60～65℃，开始滴丸；
步骤4，沥油选丸和包装：将滴制出来的滴丸放在集丸离心机的网袋中，，以每次离心的产品重量≤2kg，离心时间4～6分钟，离心转速600～800r/min，进行离心，待沥尽冷凝剂后，将滴丸放入方形的擦油转笼孔形中选丸，将并且选出的合格滴丸收集于双层洁净低密度聚乙烯袋内，密封、称重、检验。
实施例2：
步骤1，按重量份分别称取：金钱草8份、郁金11份、枳壳7份、白芍7份、黄芪8份和石韦7份分别依次加入反应釜中，并且以搅拌速度为400～500r/min，搅拌混合，并且按照药材与水重量比1:4加入水并且加热至60～80℃提取0.8～1h，并且通过400～600目滤布过滤，滤液浓缩至1:1的膏状，即中药组合提取物A，备用；
步骤2，按重量份分别称取：阿嗪米特15份、胰酶11份，在22～24℃下，分别依次将阿嗪米特15份、胰酶11份，加入步骤1中得到的中药组合提取物，以搅拌混合拌速度为300～400r/min，并且持续搅拌30～40min，搅拌混合得粘稠状物B；
步骤3，滴丸：滴丸机内加入二甲硅油40份为冷凝剂，当滴丸机油浴温度升至50～55℃时，将待滴料加入调料罐内，用1排滴盘2.5#滴头进行滴制，设定药液启动温度60～65℃，开始滴丸；
步骤4，沥油选丸和包装：将滴制出来的滴丸放在集丸离心机的网袋中，，以每次离心的产品重量≤2kg，离心时间4～6分钟，离心转速600～800r/min，进行离心，待沥尽冷凝剂后，将滴丸放入方形的擦油转笼孔形中选丸，将并且选出的合格滴丸收集于双层洁净低密度聚乙烯袋内，密封、称重、检验。
实施例3：
步骤1，按重量份分别称取：金钱草8份、郁金11份、枳壳7份、白芍7份、黄芪5份和石韦7份分别依次加入反应釜中，并且以搅拌速度为400～500r/min，搅拌混合，并且按照药材与水重量比1:4加入水并且加热至60～80℃提取0.8～1h，并且通过400～600目滤布过滤，滤液浓缩至1:1的膏状，即中药组合提取物A，备用；
步骤2，按重量份分别称取：阿嗪米特116份、胰酶12份，在22～24℃下，分别依次将阿嗪米特16份、胰酶12份，加入步骤1中得到的中药组合提取物，以搅拌混合拌速度为300～400r/min，并且持续搅拌30～40min，搅拌混合得粘稠状物B；
步骤3，滴丸：滴丸机内加入二甲硅油40份为冷凝剂，当滴丸机油浴温度升至50～55℃时，将待滴料加入调料罐内，用1排滴盘2.5#滴头进行滴制，设定药液启动温度60～65℃，开始滴丸；
步骤4，沥油选丸和包装：将滴制出来的滴丸放在集丸离心机的网袋中，，以每次离心的产品重量≤2kg，离心时间4～6分钟，离心转速600～800r/min，进行离心，待沥尽冷凝剂后，将滴丸放入方形的擦油转笼孔形中选丸，将并且选出的合格滴丸收集于双层洁净低密度聚乙烯袋内，密封、称重、检验。
取上述制得的固定制剂胆结石药丸，将76例临床确诊为慢性胆结石患者按数字随机法分为治疗组和对照组各38例结果治疗组患者采用复方阿嗪米特肠溶片治疗,每天2粒,每天3次,共治疗1个月。对照组口服消炎利胆片1个月,每次6片,每天1次。比较两组患者的疗效,不良反应和并发症发生率以及腹胀症状积分变化。与对照组比较疗组的疗效显著升高,不良反应和并发症发生率以及腹胀症状积分均下降,差异有统计学意义(P<0.05)。结论复方阿嗪米特治疗慢性胆结石可有效提高疗效,缓解患者腹胀症状并降低不良反应和并发症的发生率,值得临床推广使用。
以上所述，仅为本发明较佳的具体实施方式，但本发明的保护范围并不局限于此，任何熟悉本技术领域的技术人员在本发明揭露的技术范围内，根据本发明的技术方案及其发明构思加以等同替换或改变，都应涵盖在本发明的保护范围之内。
Claims (6)
1.一种胆结石药品制剂，其特征在于，包括阿嗪米特、胰酶、二甲硅油、金钱草、郁金、枳壳、白芍、黄芪和石韦，并且各成分按照重量份比分别为：阿嗪米特14～16份、胰酶10～12份、二甲硅油30～40份、金钱草7～9份、郁金10～12份、枳壳6～8份、白芍6～8份、黄芪4～6份和石韦6～8份。
2.根据权利要求1所述的一种胆结石药品制剂的制备方法，其特征在于，包括以下步骤：
S1，按重量份分别称取：金钱草7～9份、郁金10～12份、枳壳6～8份、白芍6～8份、黄芪4～6份和石韦6～8份分别依次加入反应釜中，并且搅拌混合，并且按照药材与水重量比1:4加入水并且加热至60～80℃提取0.8～1h，过滤，滤液浓缩至1:1的膏状，即中药组合提取物A，备用；
S2，按重量份分别称取：阿嗪米特14～16份、胰酶10～12份，在常温下，分别依次将阿嗪米特14～16份、胰酶10～12份，加入S1中得到的中药组合提取物，搅拌混合得粘稠状物B；
S3，滴丸：滴丸机内加入二甲硅油30～40份为冷凝剂，当滴丸机油浴温度升至50～55℃时，将待滴料加入调料罐内，用1排滴盘2.5#滴头进行滴制，设定药液启动温度60～65℃，开始滴丸；
S4，沥油选丸和包装：将滴制出来的滴丸放在集丸离心机的网袋中，进行离心，待沥尽冷凝剂后，将滴丸放入方形的擦油转笼孔形中选丸，将并且选出的合格滴丸收集于双层洁净低密度聚乙烯袋内，密封、称重、检验。
3.根据权利要求2所述的一种胆结石药品制剂及其制备方法，其特征在于，所述S1中搅拌混合的搅拌速度为400～500r/min，过滤，采用400～600目滤布过滤。
4.根据权利要求1所述的一种胆结石药品制剂及其制备方法，其特征在于，所述S2中的常温为22～24℃，所述S2中搅拌混合拌速度为300～400r/min，并且持续搅拌30～40min。
5.根据权利要求1所述的一种胆结石药品制剂及其制备方法，其特征在于，所述S1中滤液浓缩至1:1的膏状即1ml膏相当于1g药材。
6.根据权利要求1所述的一种胆结石药品制剂及其制备方法，其特征在于，所述S4中离心每次离心的产品重量≤2kg，离心时间4～6分钟，离心转速600～800r/min。
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