CN112843130A - 一种药物组合物 - Google Patents

一种药物组合物 Download PDF

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CN112843130A
CN112843130A CN202110071749.5A CN202110071749A CN112843130A CN 112843130 A CN112843130 A CN 112843130A CN 202110071749 A CN202110071749 A CN 202110071749A CN 112843130 A CN112843130 A CN 112843130A
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lactobacillus acidophilus
enterococcus faecalis
bifidobacterium longum
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陈启仪
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Shanghai Tenth Peoples Hospital
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Abstract

本发明公开了一种药物组合物，按重量份数比制成此药物组合物的药效原料为：西牛黄60～65份；冰片90～100份；珍珠90～95份；人指甲150～155份；象牙屑900～1000份；青黛1800～1850份；壁钱20000～21000份；地塞米松5～8份；甲硝唑500～550份；果胶5000～5100份；长型双歧杆菌、嗜酸乳杆菌和粪肠球菌共210～220份。本发明的药物组合物能够显著治疗溃疡性结直肠炎、疗射性直肠损伤和直肠吻合口溃疡，放射性直肠损伤有效率达63.32％，溃疡性结直肠炎有效率52.6％。吻合口溃疡有效率42.83％；而传统治疗方法的有效率低于20％。

Description

一种药物组合物
技术领域
本发明涉及药物技术领域，尤其涉及一种药物组合物。
背景技术
慢性溃疡性结肠炎是一种原因不明的以大肠(主要是直肠和结肠)粘膜和粘膜下层为特点的慢性炎症性疾病。血性腹泻是最常见的早期症状。其他症状依次有腹痛、便血、体重减轻、里急后重、呕吐等。此病在1875年被首次描述，开始称为单纯性溃疡性结肠炎，后又称为非特异性结肠炎。
溃疡性结肠炎，目前传统的治疗基本上是采取药物和针剂，以及手术切除整个结肠治疗。现在药物治疗多采用类似水杨酸类药物和糖皮质激素等，比如：柳氮磺胺吡啶，5-氨基水杨酸，硫唑嘌呤、6-巯基嘌呤(6-MP)、环孢霉素等药物和制剂。而这些药物中，像磺胺吡啶对肝脏的副作用很大，且不能与抗生素共用或长期应用。手术治疗，就是切除整个结肠，但由于手术的并发症较多，严重影响术后患者的生命质量。因此国内外都在寻求对此病安全有效的治疗措施。
放射性直肠炎(radiation proctitis，RP)是指因盆腔恶性肿瘤如宫颈癌、子宫内膜癌、卵巢癌、前列腺癌、直肠癌、膀胱癌等患者接受放疗后引起的直肠放射性损伤。根据起病时间及病程变化情况，可分为急性放射性直肠炎(acute radiation proctitis，ARP)和慢性放射性直肠炎(chronic radiation proctitis，CRP)。超过75％的接受盆腔放疗的患者会发生ARP，5％～20％的患者会发展为CRP。放射性直肠损伤主要表现为便血。放射性直肠炎伴出血无特效药物，主要要有创操作如内镜、局部注射等，且疗效欠佳。
吻合口溃疡尤其是直肠低位吻合口溃疡发生率较高，病人可表现为便血、肛门部追涨感，严重影响生活治疗和危机生命，但先无特效治疗手段，主要局部使用减轻水肿药物。
因此，需要找到一种药物组合物，能够显著治疗溃疡性结直肠炎、疗射性直肠损伤和直肠吻合口溃疡。
发明内容
本发明的目的是针对现有技术中的不足，提供一种药物组合物，能够显著治疗溃疡性结直肠炎、疗射性直肠损伤和直肠吻合口溃疡。
为实现上述目的，本发明采取的技术方案是：
提供一种药物组合物，按重量份数比制成此药物组合物的药效原料为：西牛黄60～65份；冰片90～100份；珍珠90～95份；人指甲150～155份；象牙屑900～1000份；青黛1800～1850份；壁钱20000～21000份；地塞米松5～8份；甲硝唑500～550份；果胶5000～5100份；长型双歧杆菌、嗜酸乳杆菌和粪肠球菌共210～220份。
进一步地，按重量份数比制成所述药物组合物的药效原料为：西牛黄60份；冰片90份；珍珠90份；人指甲150份；象牙屑900份；青黛1800份；壁钱20000份；地塞米松5份；甲硝唑500份；果胶5000份；长型双歧杆菌、嗜酸乳杆菌和粪肠球菌共210份。
进一步地，按重量份数比制成此药物组合物的药效原料为：按重量份数比制成所述药物组合物的药效原料为：西牛黄65份；冰片100份；珍珠95份；人指甲155份；象牙屑1000份；青黛1850份；壁钱21000份；地塞米松8份；甲硝唑550份；果胶5100份；长型双歧杆菌、嗜酸乳杆菌和粪肠球菌共220份。
进一步地，所述长型双歧杆菌、嗜酸乳杆菌和粪肠球菌的活菌量≥1.0×107CFU。
进一步地，所述壁钱采自土壁砖上。
进一步地，所述药物组合物的制备方法包括如下步骤：按重量份数将西牛黄、冰片、珍珠、人指甲、象牙屑、青黛和壁钱的混合粉末，地塞米松，甲硝唑，以及长型双歧杆菌、嗜酸乳杆菌和粪肠球菌的混合粉末；混入2.5×105份的生理盐水中，形成混悬液。
进一步地，所述药物组合物与生理盐水形成混悬剂使用。
本发明采用以上技术方案，与现有技术相比，具有如下技术效果：
本发明的药物组合物能够显著治疗溃疡性结直肠炎、疗射性直肠损伤和直肠吻合口溃疡，放射性直肠损伤有效率达63.32％，溃疡性结直肠炎有效率52.6％。吻合口溃疡有效率42.83％；而传统治疗方法的有效率低于20％。
本发明的药物组合物由植物中草药和西药组成，中药方具有清热解毒，收敛，去腐生肌作用，地塞米松可降低局部免疫炎症反应，甲硝唑可局部抗感染左右，降低出血部位的炎症反应，修复创面，缓解或者治愈出血。
具体实施方式
下面具体实施例对本发明作进一步说明，但不作为本发明的限定。需要说明的是，在不冲突的情况下，本发明中的实施例及实施例中的特征可以相互组合。
实施例1
药物组合物包括：西牛黄0.06g；冰片0.09g；珍珠0.09g；人指甲0.15g；象牙屑0.9g(焙)；青黛1.8g(去脚灰，净)；壁钱20g(焙，土壁砖上者可以用，木板上不可用)；地塞米松5mg；甲硝唑0.5g；果胶5g；长型双歧杆菌、嗜酸乳杆菌和粪肠球菌共210mg，其中活菌量大于等于1.0×107CFU。
将上述药物组合物混入生理盐水250ml中，形成混悬液，作为治疗溃疡性结直肠炎、疗射性直肠损伤和直肠吻合口溃疡的混悬剂使用。
实施例2
药物组合物包括：西牛黄0.065g；冰片0.10g；珍珠0.095g；人指甲0.155g；象牙屑1.0g(焙)；青黛1.85g(去脚灰，净)；壁钱21g(焙，土壁砖上者可以用，木板上不可用)；地塞米松8mg；甲硝唑0.55g；果胶5.1g；长型双歧杆菌、嗜酸乳杆菌和粪肠球菌共220mg，其中活菌量大于等于1.0×107CFU。
将上述药物组合物混入生理盐水250ml中，形成混悬液，作为治疗溃疡性结直肠炎、疗射性直肠损伤和直肠吻合口溃疡的混悬剂使用。
实验例：
临床研究结果显示，使用本发明药物组合灌肠可较快消除溃疡性结肠炎患者腹泻、脓血便、腹痛等临床症状，可显著改善肠粘膜病理变化，消除炎症介质，促进溃疡愈合，从而达到良好的治疗作用。同时安全性指标显示，本发明药物组合物灌肠治疗后患者肝肾功能、X线胸片、心电图、血尿常规等检查均无异常改变，未发现不良反应和毒副作用。临床研究结果如下：
1.放射性肠损伤临床研究结果：本中心共收治放射性肠损伤伴血便患者653例，经6天的连续保留灌肠，平均出血停止时间在灌肠后72小时停止，有效人数412例，有效率为63.09％。
2.溃疡性结直肠炎临床研究结果：本中心共收治溃疡性结直肠炎伴血便患者386例，经12天的连续保留灌肠，平均出血停止时间在灌肠后48小时停止，有效人数201例，有效率为52.07％。
3.吻合口溃疡临床研究结果：本中心共收治吻合口溃疡伴血便患者163例，经9天的连续保留灌肠，平均出血停止时间在灌肠后48小时停止，有效人数83例，有效率为50.92％。
上述有效＝治愈+好转，治愈：临床症状消失，肠镜等检查肠粘膜病变恢复正常；好转：临床症状减轻，肠镜等检查肠粘膜病变改善，大便常规有少量红白细胞；无效：治疗前后临床症状和肠镜等检查无改善或无明显改善。
上所述仅为本发明较佳的实施例，并非因此限制本发明的实施方式及保护范围，对于本领域技术人员而言，应当能够意识到凡运用本发明说明书内容所作出的等同替换和显而易见的变化所得到的方案，均应当包含在本发明的保护范围内。

Claims (7)

1.一种药物组合物，其特征在于，按重量份数比制成此药物组合物的药效原料为：西牛黄60～65份；冰片90～100份；珍珠90～95份；人指甲150～155份；象牙屑900～1000份；青黛1800～1850份；壁钱20000～21000份；地塞米松5～8份；甲硝唑500～550份；果胶5000～5100份；长型双歧杆菌、嗜酸乳杆菌和粪肠球菌共210～220份。
2.根据权利要求1所述的药物组合物，其特征在于，按重量份数比制成所述药物组合物的药效原料为：西牛黄60份；冰片90份；珍珠90份；人指甲150份；象牙屑900份；青黛1800份；壁钱20000份；地塞米松5份；甲硝唑500份；果胶5000份；长型双歧杆菌、嗜酸乳杆菌和粪肠球菌共210份。
3.根据权利要求1所述的药物组合物，其特征在于，按重量份数比制成所述药物组合物的药效原料为：按重量份数比制成此药物组合物的药效原料为：西牛黄65份；冰片100份；珍珠95份；人指甲155份；象牙屑1000份；青黛1850份；壁钱21000份；地塞米松8份；甲硝唑550份；果胶5100份；长型双歧杆菌、嗜酸乳杆菌和粪肠球菌共220份。
4.根据权利要求1所述的药物组合物，其特征在于，所述长型双歧杆菌、嗜酸乳杆菌和粪肠球菌的活菌量≥1.0×107CFU。
5.根据权利要求1所述的药物组合物，其特征在于，所述壁钱采自土壁砖上。
6.根据权利要求1所述的药物组合物，其特征在于，所述药物组合物的制备方法包括如下步骤：按重量份数将西牛黄、冰片、珍珠、人指甲、象牙屑、青黛和壁钱的混合粉末，地塞米松，甲硝唑，以及长型双歧杆菌、嗜酸乳杆菌和粪肠球菌的混合粉末；混入2.5×105份的生理盐水中，形成混悬液。
7.根据权利要求6所述的药物组合物，其特征在于，所述药物组合物与生理盐水形成混悬剂使用。
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