CN112587498A - 多库酯钠丹蒽醌及其制备方法 - Google Patents
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Abstract
多库酯钠丹蒽醌及其制备方法，涉及一种便秘药物及其制备方法。本发明提供了毒性和不良反应较低的多库酯钠丹蒽醌及其制备方法。多库酯钠丹蒽醌按质量份数比包括丹蒽醌、多库酯钠、水解淀粉、珍珠粉和苯甲酸钠。制备方法：一、将多库酯钠与水解淀粉按1:1的质量比混合、搅拌均匀，过筛；二、将丹蒽醌与余量水解淀粉混合均匀；三、将步骤一和步骤二的混合物与珍珠粉混合，然后加入苯甲酸钠和浓度为95％以上的乙醇，在制粒机中混合制粒，干燥，制成多库酯钠丹蒽醌胶囊颗粒。本发明可以减轻长期使用或高剂量使用库酯钠丹蒽醌药品的不良反应症状。
Description
技术领域
本发明涉及一种便秘药物及其制备方法。
背景技术
多库酯钠丹蒽醌胶囊适应症为适用于孕妇、痔疮、老弱、心血管病及肛门、妇产科等实施手术后患者出现的便秘。在原多库酯钠丹蒽醌胶囊说明书中介绍其注意事项为1.腹痛时勿服用。2.频繁或大量使用会导致轻微腹泻。3.忌与矿物油合用，因能促其吸收而产生不良反应。总体认为多库酯钠丹蒽醌是安全的。但是随着临床使用量的增加，出现了不良反应。2020年5月国家药监局修订了多库酯钠丹蒽醌胶囊说明书，不良反应由“尚未见有关报道。”修改为“使用本品，可能会出现轻微腹部绞痛。长期使用或高剂量使用后，可能会出现皮疹、皮肤刺激、皮肤变色和肛周皮肤表面脱皮、水和电解质紊乱、结肠无力、结肠黑色素沉着病(结肠粘膜变色)。观察到的不良反应个例报道还有白细胞减少合并肝损伤、皮肤颜色变为灰蓝、阴道分泌物变为橙色。”。
发明内容
本发明提供了毒性和不良反应较低的多库酯钠丹蒽醌及其制备方法。
本发明多库酯钠丹蒽醌按质量份数比包括10份丹蒽醌、20～30份多库酯钠、60～80份水解淀粉、20份珍珠粉和0.5～1份苯甲酸钠。
上述多库酯钠丹蒽醌胶囊按以下步骤制备：
一、将多库酯钠与水解淀粉按1:1的质量比混合、搅拌均匀，过筛；
二、将丹蒽醌与余量水解淀粉混合均匀；
三、将步骤一和步骤二的混合物与珍珠粉混合，然后加入苯甲酸钠和浓度为95％以上的乙醇，在制粒机中混合制粒，干燥，制成多库酯钠丹蒽醌胶囊颗粒。
上述多库酯钠丹蒽醌片按以下步骤制备：
一、将多库酯钠与水解淀粉按1:1的质量比混合、搅拌均匀，过筛；
二、将丹蒽醌与余量水解淀粉混合均匀；
三、将步骤一和步骤二的混合物与珍珠粉和崩解剂混合，然后加入苯甲酸钠、润滑剂、粘合剂和浓度为95％以上的乙醇混合制粒，干燥，压片，制成多库酯钠丹蒽醌片芯，包衣后得到多库酯钠丹蒽醌片。
本发明可以减轻长期使用或高剂量使用库酯钠丹蒽醌药品的不良反应症状。
具体实施方式
本发明技术方案不局限于以下所列举具体实施方式，还包括各具体实施方式间的任意组合。
具体实施方式一：本实施方式多库酯钠丹蒽醌按质量份数比包括10份丹蒽醌、20～30份多库酯钠、60～80份水解淀粉、20份珍珠粉和0.5～1份苯甲酸钠。
具体实施方式二：本实施方式与具体实施方式一的不同点是：多库酯钠丹蒽醌按质量份数比主要由10份丹蒽醌、24份多库酯钠、70份水解淀粉、20份珍珠粉和0.8份苯甲酸钠。其它步骤及参数与实施方式一相同。
具体实施方式三：本实施方式多库酯钠丹蒽醌胶囊按以下步骤制备：
一、按质量份数比称取10份丹蒽醌、20～30份多库酯钠、60～80份水解淀粉、20份珍珠粉和0.5～1份苯甲酸钠；
二、将多库酯钠与水解淀粉按1:1的质量比混合、搅拌均匀，过筛；
三、将丹蒽醌与余量水解淀粉混合均匀；
四、将步骤二和步骤三的混合物与珍珠粉混合，然后加入苯甲酸钠和浓度为95％以上的乙醇，在制粒机中混合制粒，干燥，制成多库酯钠丹蒽醌胶囊颗粒。
具体实施方式四：本实施方式多库酯钠丹蒽醌片按以下步骤制备：
一、按质量份数比称取10份丹蒽醌、20～30份多库酯钠、60～80份水解淀粉、20份珍珠粉和0.5～1份苯甲酸钠；
二、将多库酯钠与水解淀粉按1:1的质量比混合、搅拌均匀，过筛；
三、将丹蒽醌与余量水解淀粉混合均匀；
四、将步骤二和步骤三的混合物与珍珠粉和崩解剂混合，然后加入苯甲酸钠、润滑剂、粘合剂和浓度为95％以上的乙醇混合制粒，干燥，压片，制成多库酯钠丹蒽醌片芯，包衣后得到多库酯钠丹蒽醌片。
具体实施方式五：本实施方式与具体实施方式三或四的不同点是：步骤四干燥温度低于45℃。其它步骤及参数与实施方式三或四相同。
实施例1
一、按质量份数比称取10份丹蒽醌、24份多库酯钠、70份水解淀粉、20份珍珠粉和1份苯甲酸钠；
二、将多库酯钠与水解淀粉按1:1的质量比混合、搅拌均匀，过筛；
三、将丹蒽醌与余量水解淀粉混合均匀；
四、将步骤二和步骤三的混合物与珍珠粉混合，然后加入苯甲酸钠和无水乙醇，在制粒机中混合制粒，干燥，制成多库酯钠丹蒽醌胶囊颗粒。
本实施例制备的多库酯钠丹蒽醌胶囊和市售的多库酯钠丹蒽醌胶囊成分都为多库酯钠60mg/粒、丹蒽醌25mg/粒。用本实施例制备的多库酯钠丹蒽醌胶囊和市售的多库酯钠丹蒽醌胶囊进行对比试验：
实验1：
随机选取健康大鼠400只，平均分成2组，分别灌胃本实施例制备的多库酯钠丹蒽醌胶囊和市售的多库酯钠丹蒽醌胶囊；根据成人每日1次，一次1粒的剂量进行换算，连续灌胃大鼠14天，检查情况如表1所示。
表1
实验2：
随机选取健康大鼠400只，平均分成2组，分别灌胃本实施例制备的多库酯钠丹蒽醌胶囊和市售的多库酯钠丹蒽醌胶囊；根据成人每日1次，一次2粒的剂量进行换算，连续灌胃大鼠7天，检查情况如表2所示。
表2
临床对比使用本实施例制备的多库酯钠丹蒽醌胶囊和市售的多库酯钠丹蒽醌胶囊，服用本实施例制备的多库酯钠丹蒽醌胶囊患者出现轻微腹部绞痛和腹泻的概率比市售组患者低40％左右，而且绞痛和腹泻症状轻于市售组，恢复速度更快。
Claims (4)
1.多库酯钠丹蒽醌，其特征在于多库酯钠丹蒽醌按质量份数比包括10份丹蒽醌、20～30份多库酯钠、60～80份水解淀粉、20份珍珠粉和0.5～1份苯甲酸钠。
2.权利要求1所述多库酯钠丹蒽醌的制备方法，其特征在于多库酯钠丹蒽醌按以下步骤制备：
一、将多库酯钠与水解淀粉按1:1的质量比混合、搅拌均匀，过筛；
二、将丹蒽醌与余量水解淀粉混合均匀；
三、将步骤一和步骤二的混合物与珍珠粉混合，然后加入苯甲酸钠和浓度为95％以上的乙醇，在制粒机中混合制粒，干燥，制成多库酯钠丹蒽醌胶囊颗粒。
3.权利要求1所述多库酯钠丹蒽醌的制备方法，其特征在于多库酯钠丹蒽醌按以下步骤制备：
一、将多库酯钠与水解淀粉按1:1的质量比混合、搅拌均匀，过筛；
二、将丹蒽醌与余量水解淀粉混合均匀；
三、将步骤一和步骤二的混合物与珍珠粉和崩解剂混合，然后加入苯甲酸钠、润滑剂、粘合剂和浓度为95％以上的乙醇混合制粒，干燥，压片，制成多库酯钠丹蒽醌片芯，包衣后得到多库酯钠丹蒽醌片。
4.根据权利要求2和3所述的多库酯钠丹蒽醌的制备方法，其特征在于步骤三干燥温度低于45℃。
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