CN105770867A - 一种治疗结核性心包炎的片剂及其制备方法 - Google Patents
一种治疗结核性心包炎的片剂及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种治疗结核性心包炎的片剂及其制备方法,所述片剂是主要由以下重量份的成分组成:曲安西龙、烟酰胺、多巴、牡荆素、白杨素、天冬酰胺、琥珀酸、核黄素、棉子糖、可待因、马兜铃酸、香柑内酯、异黄酮、脱氧核苷酸、核糖核酸酶、脂溶性维生素、L‑阿拉伯糖;所述片剂还包括辅料:填充剂、崩解剂、粘合剂、润滑剂。本发明的片剂是将多种西药的有效成分合理配比,能快速的控制结核传染,并扩张冠状动脉、增加血流量,减轻心脏负担,同时具有镇静止痛、止咳平喘、清肺消肿的作用,有效的缓解患者痛苦,增强肌体免疫能力,调节患者情绪来减缓精神负担,本发明片剂制备工艺简单,使用方便,副作用小可长期服用。
Description
技术领域
本发明涉及心血管内科用药技术领域,具体是涉及一种治疗结核性心包炎的片剂及其制备方法。
背景技术
近年来结核性心包炎逐渐成为一种临床常见的多发性疾病,其早期为纤维素性和血性心包炎,继而发病为心包积液,随后心包肥厚,可转为亚急性期或慢性期,部分发展为心包缩窄。结核性心包炎通常由气管、支气管周围及纵隔淋巴结核直接蔓延而来,或者由原发肺结核或胸膜结核感染血源性播散,少见的心包受累是远隔的泌尿系统结核、骨结核血行播散而致。结核性心包炎早期为纤维素性和血性心包炎,继以心包积液,随后心包肥厚,可转为亚急性期或慢性期,部分发展为心包缩窄。结核性心包炎的体征主要有:心动过速、心界扩大、心音遥远、偶有心包摩擦音、40%~50%并胸腔积液、大量者可致心脏压塞,可出现颈静脉怒张、奇脉、肝脏肿大、端坐呼吸、下肢水肿等。结核性心包炎发展为慢性缩窄性心包炎时无发热、盗汗等症状,而突出表现为颈静脉怒张、低血压及脉压小、腹部膨胀、腹腔积液及水肿等。患者多为年轻人,男性多见,起病缓慢,主要是非特异性全身症状,常有发热、胸痛、心悸、咳嗽、呼吸困难、食欲减退、消瘦乏力及盗汗等。常出现在心包渗液阶段或晚期缩窄性心包炎阶段。胸痛较急性病毒性或非特异性心肌炎为轻,若合并有肺结核可有咳嗽及咯血。
结核性心包炎的早期治疗对于预后效果是很关键的,目前主要是抗结核治疗或外科治疗,积极控制结核的流行能显著减少结核性心包炎的发病率,手术治疗可使预后改善,多数重症患者可以采取手术治疗,大多数患者以药物治疗为主,因此针对结核性心包炎的病理来说及时性的抵制结核的传染,多方面的预防和治疗多种并发症是及其重要的,这是目前此疾病在医学界的研究重点。
发明内容
本发明解决的技术问题是,提供一种治疗结核性心包炎的片剂及其制备方法。
本发明的技术方案是,一种治疗结核性心包炎的片剂,所述片剂是主要由以下重量份的成分组成:曲安西龙3-5份、烟酰胺8-12份、多巴9-14份、牡荆素12-15份、白杨素8-10份、天冬酰胺5-8份、琥珀酸6-10份、核黄素1-3份、棉子糖12-18份、可待因2-5份、马兜铃酸3-8份、香柑内酯6-12份、异黄酮0.5-1.5份、脱氧核苷酸0.8-1.6份、核糖核酸酶0.1-0.3份、脂溶性维生素3-8份、L-阿拉伯糖7-16份;所述片剂还包括辅料:填充剂110-150份、崩解剂18-26份、粘合剂30-50份、润滑剂8-12份。
进一步的,所述的白杨素制备方法为:取新鲜山白松的心木清洗干净后,干燥使其水分含量低于3%,粉碎过20-30目筛得到粗粉,将粗粉置于提取器中,加入粗粉重量0.6%-0.9%的生物酶,所述的生物酶为果胶酶、纤维素酶、半纤维素酶按照1:3:5的重量比混合制得的,可以有效的对山白松木心木中的含有白杨素的化合物进行酶解,同时加入粗粉重量6-8倍量的质量浓度为50-70%的乙醇,在pH值4-5,温度为36-45℃的条件下酶解2-3h,酶解完后将提取器中混合液进行超声提取45-60min,超声提取频率为25-35KHz,温度条件36-48℃过滤提取液后将得到的滤液减压浓缩成浸膏,给浸膏中加入3-5倍量的蒸馏水进行溶解,使用大孔吸附树脂吸附,再用5-8倍量的质量浓度为60-80%的乙醇溶液洗脱,将洗脱液通过溶液泵以高压状态急速喷入结晶釜内进行结晶,收集析出晶体即得到白杨素,白杨素具有很好的预防心脑血管疾病、抗菌、消炎的作用。
进一步的,所述的填充剂为微晶纤维素、乳糖或倍他环糊精中的任意一种或两种以上的任意组合,此类填充剂流动性、可压性好,结合力强,对药物有较大的容纳量。
进一步的,所述的崩解剂为羧甲基淀粉钠、低取代羟丙基纤维素或交联羧甲基纤维素钠中的任意一种或两种以上的任意组合,此类崩解剂吸水膨胀作用非常显著,崩解后的颗粒非常细小,有利于药物的溶出,崩解性能优越。
进一步的,所述的粘合剂为预交化淀粉、阿拉伯胶或羟丙基纤维素中的任意一种或两种以上的任意组合,此类粘合剂易溶于水,粘度强,在湿法制粒中能有效的将药物混合物中的各组份粘结,便于制粒。
进一步的,所述的润滑剂为硬脂酸镁、二氧化硅或滑石粉中的任意一种或两种以上的任意组合,此类润滑剂有效的降低颗粒之间的摩擦,改善粉末流动性,便于药物制粒中的均匀性。
一种治疗结核性心包炎的片剂的制备方法为:
步骤一:取新鲜山白松的心木清洗干净后,干燥使其水分含量低于3%,粉碎过20-30目筛得到粗粉,将粗粉置于提取器中,加入粗粉重量0.6%-0.9%的生物酶,所述的生物酶为果胶酶、纤维素酶、半纤维素酶按照1:3:5的重量比混合制得的,可以有效的对山白松木心木中的含有白杨素的化合物进行酶解,同时加入粗粉重量6-8倍量的质量浓度为50-70%的乙醇,在pH值4-5,温度为36-45℃的条件下酶解2-3h,酶解完后将提取器中混合液进行超声提取45-60min,超声提取频率为25-35KHz,温度条件36-48℃过滤提取液后将得到的滤液减压浓缩成浸膏,给浸膏中加入3-5倍量的蒸馏水进行溶解,使用大孔吸附树脂吸附,再用5-8倍量的质量浓度为60-80%的乙醇溶液洗脱,将洗脱液通过溶液泵以高压状态急速喷入结晶釜内进行结晶,收集析出晶体即得到白杨素,白杨素具有很好的预防心脑血管疾病、抗菌、消炎的作用;
步骤二:将所述重量组份的曲安西龙、烟酰胺、多巴、牡荆素、白杨素、天冬酰胺、琥珀酸、核黄素、棉子糖、可待因、马兜铃酸、香柑内酯、异黄酮、脱氧核苷酸、核糖核酸酶、脂溶性维生素、L-阿拉伯糖使用机械搅拌,置于搅拌机以120-180r/min,搅拌30-45min后得到混合药粉,再将混合药粉研磨粉碎,过200-300目筛,制成混合药物细粉,使药物的有效成分能够充分的释放,并且不会在压片过程中出现分层,备用;
步骤三:将所述重量组份的粘合剂和纯化水按照1:4-6的重量比混合溶解配制成粘合剂溶液,药用纯化水中无任何添加剂,可以使药物中的有效成分在制备片剂的过程中不受影响,更好的发挥药效,其检测标准为“中华人民共和国药典2010年版”中对于纯化水检验项目要求的标准,备用;
步骤四:将步骤二制备的混合药物细粉和所述重量组份的填充剂混合均匀,加入步骤三制备的粘合剂溶液中,制备成湿颗粒,再将湿颗粒干燥并整粒得到干颗粒,干燥温度35-45℃,给干颗粒中加入所述重量组份的崩解剂、润滑剂,混合均匀后压制成片剂,即制备治疗结核性心包炎的片剂。
本发明的有益效果体现在:将多种西药的有效成分合理配比,曲安西龙、烟酰胺、多巴、牡荆素、白杨素、天冬酰胺联合用药能快速的控制结核传染,并扩张冠状动脉、增加血流量,减轻心脏负担,同时具有镇静止痛、止咳平喘、清肺消肿的作用,琥珀酸、核黄素、棉子糖、可待因、马兜铃酸、香柑内酯、异黄酮、脱氧核苷酸、核糖核酸酶、脂溶性维生素、L-阿拉伯糖联合作用有效的缓解患者的心动过速、胸腔积液、心脏压塞,静脉怒张、肝脏肿大、下肢水肿等临床症状,增强肌体免疫能力,调节患者情绪来减缓精神负担,本发明片剂制备工艺简单,使用方便,副作用小可长期服用。
具体实施方式
实施例1:一种治疗结核性心包炎的片剂,所述片剂是主要由以下重量份的成分组成:曲安西龙3份、烟酰胺8份、多巴9份、牡荆素12份、白杨素8份、天冬酰胺5份、琥珀酸6份、核黄素1份、棉子糖12份、可待因2份、马兜铃酸3份、香柑内酯6份、异黄酮0.5份、脱氧核苷酸0.8份、核糖核酸酶0.1份、脂溶性维生素3份、L-阿拉伯糖7份;所述片剂还包括辅料:填充剂110份、崩解剂18份、粘合剂30份、润滑剂8份。
其中,所述的白杨素制备方法为:取新鲜山白松的心木清洗干净后,干燥使其水分含量低于3%,粉碎过20目筛得到粗粉,将粗粉置于提取器中,加入粗粉重量0.6%的生物酶,所述的生物酶为果胶酶、纤维素酶、半纤维素酶按照1:3:5的重量比混合制得的,可以有效的对山白松木心木中的含有白杨素的化合物进行酶解,同时加入粗粉重量6倍量的质量浓度为50%的乙醇,在pH值4,温度为36℃的条件下酶解2h,酶解完后将提取器中混合液进行超声提取45min,超声提取频率为25KHz,温度条件36℃过滤提取液后将得到的滤液减压浓缩成浸膏,给浸膏中加入3倍量的蒸馏水进行溶解,使用大孔吸附树脂吸附,再用5倍量的质量浓度为60%的乙醇溶液洗脱,将洗脱液通过溶液泵以高压状态急速喷入结晶釜内进行结晶,收集析出晶体即得到白杨素,白杨素具有很好的预防心脑血管疾病、抗菌、消炎的作用。所述的填充剂为微晶纤维素,此类填充剂流动性、可压性好,结合力强,对药物有较大的容纳量。所述的崩解剂为羧甲基淀粉钠,此类崩解剂吸水膨胀作用非常显著,崩解后的颗粒非常细小,有利于药物的溶出,崩解性能优越。所述的粘合剂为预交化淀粉,此类粘合剂易溶于水,粘度强,在湿法制粒中能有效的将药物混合物中的各组份粘结,便于制粒。所述的润滑剂为硬脂酸镁,此类润滑剂有效的降低颗粒之间的摩擦,改善粉末流动性,便于药物制粒中的均匀性。
一种治疗结核性心包炎的片剂的制备方法为:
步骤一:取新鲜山白松的心木清洗干净后,干燥使其水分含量低于3%,粉碎过20目筛得到粗粉,将粗粉置于提取器中,加入粗粉重量0.6%的生物酶,所述的生物酶为果胶酶、纤维素酶、半纤维素酶按照1:3:5的重量比混合制得的,可以有效的对山白松木心木中的含有白杨素的化合物进行酶解,同时加入粗粉重量6倍量的质量浓度为50%的乙醇,在pH值4,温度为36℃的条件下酶解2h,酶解完后将提取器中混合液进行超声提取45min,超声提取频率为25KHz,温度条件36℃过滤提取液后将得到的滤液减压浓缩成浸膏,给浸膏中加入3倍量的蒸馏水进行溶解,使用大孔吸附树脂吸附,再用5倍量的质量浓度为60%的乙醇溶液洗脱,将洗脱液通过溶液泵以高压状态急速喷入结晶釜内进行结晶,收集析出晶体即得到白杨素,白杨素具有很好的预防心脑血管疾病、抗菌、消炎的作用;
步骤二:将所述重量组份的曲安西龙、烟酰胺、多巴、牡荆素、白杨素、天冬酰胺、琥珀酸、核黄素、棉子糖、可待因、马兜铃酸、香柑内酯、异黄酮、脱氧核苷酸、核糖核酸酶、脂溶性维生素、L-阿拉伯糖使用机械搅拌,置于搅拌机以120r/min,搅拌30min后得到混合药粉,再将混合药粉研磨粉碎,过200目筛,制成混合药物细粉,使药物的有效成分能够充分的释放,并且不会在压片过程中出现分层,备用;
步骤三:将所述重量组份的粘合剂和纯化水按照1:4的重量比混合溶解配制成粘合剂溶液,药用纯化水中无任何添加剂,可以使药物中的有效成分在制备片剂的过程中不受影响,更好的发挥药效,其检测标准为“中华人民共和国药典2010年版”中对于纯化水检验项目要求的标准,备用;
步骤四:将步骤二制备的混合药物细粉和所述重量组份的填充剂混合均匀,加入步骤三制备的粘合剂溶液中,制备成湿颗粒,再将湿颗粒干燥并整粒得到干颗粒,干燥温度35℃,给干颗粒中加入所述重量组份的崩解剂、润滑剂,混合均匀后压制成片剂,即制备治疗结核性心包炎的片剂。
实施例2:一种治疗结核性心包炎的片剂,所述片剂是主要由以下重量份的成分组成:曲安西龙4份、烟酰胺10份、多巴11.5份、牡荆素13.5份、白杨素9份、天冬酰胺6.5份、琥珀酸8份、核黄素2份、棉子糖15份、可待因3.5份、马兜铃酸5.5份、香柑内酯9份、异黄酮1份、脱氧核苷酸1.2份、核糖核酸酶0.2份、脂溶性维生素5.5份、L-阿拉伯糖11.5份;所述片剂还包括辅料:填充剂130份、崩解剂22份、粘合剂40份、润滑剂10份。
其中,所述的白杨素制备方法为:取新鲜山白松的心木清洗干净后,干燥使其水分含量低于3%,粉碎过25目筛得到粗粉,将粗粉置于提取器中,加入粗粉重量0.75%的生物酶,所述的生物酶为果胶酶、纤维素酶、半纤维素酶按照1:3:5的重量比混合制得的,可以有效的对山白松木心木中的含有白杨素的化合物进行酶解,同时加入粗粉重量7倍量的质量浓度为60%的乙醇,在pH值4.5,温度为40.5℃的条件下酶解2.5h,酶解完后将提取器中混合液进行超声提取52.5min,超声提取频率为30KHz,温度条件42℃过滤提取液后将得到的滤液减压浓缩成浸膏,给浸膏中加入4倍量的蒸馏水进行溶解,使用大孔吸附树脂吸附,再用6.5倍量的质量浓度为70%的乙醇溶液洗脱,将洗脱液通过溶液泵以高压状态急速喷入结晶釜内进行结晶,收集析出晶体即得到白杨素,白杨素具有很好的预防心脑血管疾病、抗菌、消炎的作用。所述的填充剂为乳糖,此类填充剂流动性、可压性好,结合力强,对药物有较大的容纳量。所述的崩解剂为低取代羟丙基纤维素,此类崩解剂吸水膨胀作用非常显著,崩解后的颗粒非常细小,有利于药物的溶出,崩解性能优越。所述的粘合剂为阿拉伯胶,此类粘合剂易溶于水,粘度强,在湿法制粒中能有效的将药物混合物中的各组份粘结,便于制粒。所述的润滑剂为二氧化硅,此类润滑剂有效的降低颗粒之间的摩擦,改善粉末流动性,便于药物制粒中的均匀性。
一种治疗结核性心包炎的片剂的制备方法为:
步骤一:取新鲜山白松的心木清洗干净后,干燥使其水分含量低于3%,粉碎过25目筛得到粗粉,将粗粉置于提取器中,加入粗粉重量0.75%的生物酶,所述的生物酶为果胶酶、纤维素酶、半纤维素酶按照1:3:5的重量比混合制得的,可以有效的对山白松木心木中的含有白杨素的化合物进行酶解,同时加入粗粉重量7倍量的质量浓度为60%的乙醇,在pH值4.5,温度为40.5℃的条件下酶解2.5h,酶解完后将提取器中混合液进行超声提取52.5min,超声提取频率为30KHz,温度条件42℃过滤提取液后将得到的滤液减压浓缩成浸膏,给浸膏中加入4倍量的蒸馏水进行溶解,使用大孔吸附树脂吸附,再用6.5倍量的质量浓度为70%的乙醇溶液洗脱,将洗脱液通过溶液泵以高压状态急速喷入结晶釜内进行结晶,收集析出晶体即得到白杨素,白杨素具有很好的预防心脑血管疾病、抗菌、消炎的作用;
步骤二:将所述重量组份的曲安西龙、烟酰胺、多巴、牡荆素、白杨素、天冬酰胺、琥珀酸、核黄素、棉子糖、可待因、马兜铃酸、香柑内酯、异黄酮、脱氧核苷酸、核糖核酸酶、脂溶性维生素、L-阿拉伯糖使用机械搅拌,置于搅拌机以150r/min,搅拌37.5min后得到混合药粉,再将混合药粉研磨粉碎,过250目筛,制成混合药物细粉,使药物的有效成分能够充分的释放,并且不会在压片过程中出现分层,备用;
步骤三:将所述重量组份的粘合剂和纯化水按照1:5的重量比混合溶解配制成粘合剂溶液,药用纯化水中无任何添加剂,可以使药物中的有效成分在制备片剂的过程中不受影响,更好的发挥药效,其检测标准为“中华人民共和国药典2010年版”中对于纯化水检验项目要求的标准,备用;
步骤四:将步骤二制备的混合药物细粉和所述重量组份的填充剂混合均匀,加入步骤三制备的粘合剂溶液中,制备成湿颗粒,再将湿颗粒干燥并整粒得到干颗粒,干燥温度40℃,给干颗粒中加入所述重量组份的崩解剂、润滑剂,混合均匀后压制成片剂,即制备治疗结核性心包炎的片剂。
实施例3:一种治疗结核性心包炎的片剂,所述片剂是主要由以下重量份的成分组成:曲安西龙5份、烟酰胺12份、多巴14份、牡荆素15份、白杨素10份、天冬酰胺8份、琥珀酸10份、核黄素3份、棉子糖18份、可待因5份、马兜铃酸8份、香柑内酯12份、异黄酮1.5份、脱氧核苷酸1.6份、核糖核酸酶0.3份、脂溶性维生素8份、L-阿拉伯糖16份;所述片剂还包括辅料:填充剂150份、崩解剂26份、粘合剂50份、润滑剂12份。
其中,所述的白杨素制备方法为:取新鲜山白松的心木清洗干净后,干燥使其水分含量低于3%,粉碎过30目筛得到粗粉,将粗粉置于提取器中,加入粗粉重量0.9%的生物酶,所述的生物酶为果胶酶、纤维素酶、半纤维素酶按照1:3:5的重量比混合制得的,可以有效的对山白松木心木中的含有白杨素的化合物进行酶解,同时加入粗粉重量8倍量的质量浓度为70%的乙醇,在pH值5,温度为45℃的条件下酶解3h,酶解完后将提取器中混合液进行超声提取60min,超声提取频率为35KHz,温度条件48℃过滤提取液后将得到的滤液减压浓缩成浸膏,给浸膏中加入5倍量的蒸馏水进行溶解,使用大孔吸附树脂吸附,再用8倍量的质量浓度为80%的乙醇溶液洗脱,将洗脱液通过溶液泵以高压状态急速喷入结晶釜内进行结晶,收集析出晶体即得到白杨素,白杨素具有很好的预防心脑血管疾病、抗菌、消炎的作用。所述的填充剂为倍他环糊精,此类填充剂流动性、可压性好,结合力强,对药物有较大的容纳量。所述的崩解剂为交联羧甲基纤维素钠,此类崩解剂吸水膨胀作用非常显著,崩解后的颗粒非常细小,有利于药物的溶出,崩解性能优越。所述的粘合剂为羟丙基纤维素,此类粘合剂易溶于水,粘度强,在湿法制粒中能有效的将药物混合物中的各组份粘结,便于制粒。所述的润滑剂为滑石粉,此类润滑剂有效的降低颗粒之间的摩擦,改善粉末流动性,便于药物制粒中的均匀性。
一种治疗结核性心包炎的片剂的制备方法为:
步骤一:取新鲜山白松的心木清洗干净后,干燥使其水分含量低于3%,粉碎过30目筛得到粗粉,将粗粉置于提取器中,加入粗粉重量0.9%的生物酶,所述的生物酶为果胶酶、纤维素酶、半纤维素酶按照1:3:5的重量比混合制得的,可以有效的对山白松木心木中的含有白杨素的化合物进行酶解,同时加入粗粉重量8倍量的质量浓度为70%的乙醇,在pH值5,温度为45℃的条件下酶解3h,酶解完后将提取器中混合液进行超声提取60min,超声提取频率为35KHz,温度条件48℃过滤提取液后将得到的滤液减压浓缩成浸膏,给浸膏中加入5倍量的蒸馏水进行溶解,使用大孔吸附树脂吸附,再用8倍量的质量浓度为80%的乙醇溶液洗脱,将洗脱液通过溶液泵以高压状态急速喷入结晶釜内进行结晶,收集析出晶体即得到白杨素,白杨素具有很好的预防心脑血管疾病、抗菌、消炎的作用;
步骤二:将所述重量组份的曲安西龙、烟酰胺、多巴、牡荆素、白杨素、天冬酰胺、琥珀酸、核黄素、棉子糖、可待因、马兜铃酸、香柑内酯、异黄酮、脱氧核苷酸、核糖核酸酶、脂溶性维生素、L-阿拉伯糖使用机械搅拌,置于搅拌机以180r/min,搅拌45min后得到混合药粉,再将混合药粉研磨粉碎,过300目筛,制成混合药物细粉,使药物的有效成分能够充分的释放,并且不会在压片过程中出现分层,备用;
步骤三:将所述重量组份的粘合剂和纯化水按照1:6的重量比混合溶解配制成粘合剂溶液,药用纯化水中无任何添加剂,可以使药物中的有效成分在制备片剂的过程中不受影响,更好的发挥药效,其检测标准为“中华人民共和国药典2010年版”中对于纯化水检验项目要求的标准,备用;
步骤四:将步骤二制备的混合药物细粉和所述重量组份的填充剂混合均匀,加入步骤三制备的粘合剂溶液中,制备成湿颗粒,再将湿颗粒干燥并整粒得到干颗粒,干燥温度45℃,给干颗粒中加入所述重量组份的崩解剂、润滑剂,混合均匀后压制成片剂,即制备治疗结核性心包炎的片剂。
本发明药物的动物毒性试验
选取SD大鼠80只,雌雄兼用,体重180-230g,分成四组,每组20只,其中一组为超剂量试验组按照50ml/kg的用量使用本发明实施例2制备的片剂,其他三组正常剂量试验组,正常剂量试验组按照10ml/kg的用量分别使用本发明实施例1、实施例2、实施例3制备的片剂;给药方式为将本发明制备的片剂研磨成细粉后加入细粉10倍量的纯净水进行灌胃给药,每天两次,连服15天,每天观察给药反应,结果表明四组大鼠活动、饮食正常,解剖后对大鼠体内肝、胃等主要器官进行检验,均显示正常,未发现任何损伤,因此断定本发明制备的片剂暂未发现任何不良的毒副作用。
临床试验:
1.临床病例选择并分组:发明人共收集90例确诊的结核性心包炎患者,随机分为三组,每组30人,三组试验组,一组对照组,三组性别、年龄、病情等资料均无显著性差异,具有可比性。
2.诊断标准:临床表现为发热、胸痛、心悸、咳嗽、呼吸困难、食欲减退、消瘦乏力及盗汗等,体征表现为:心动过速、心界扩大、心音遥远、偶有心包摩擦音、40%~50%并胸腔积液、大量者可致心脏压塞,可出现颈静脉怒张、奇脉、肝脏肿大、端坐呼吸、下肢水肿等,症状严重表现为颈静脉怒张、低血压及脉压小、腹部膨胀、腹腔积液及水肿等。
3.试验方法:分别给试验组患者服用实施例1、实施例2、实施例3制备的片剂,每天服用2次,每次0.5g,7天为一个疗程,实验周期为三个疗程。
4.疗效标准与治疗结果
4.1疗效标准
显效:临床症状消失,心脏异常消失,各项体征恢复正常,观察半年无复发者;
好转:临床症状明显好转,各项体征有所改善,体质逐步恢复;
无效:临床症状未缓解或加重。
4.2治疗统计结果
表1—三组疗效比较
服用的药物 | 病例人数 | 显效 | 好转 | 无效 | 不良反应 | 总有效率% |
实施例1 | 30 | 13 | 13 | 4 | 0 | 86.7 |
实施例2 | 30 | 18 | 11 | 1 | 0 | 96.7 |
实施例3 | 30 | 16 | 12 | 2 | 0 | 93.3 |
5.结论:临床试验过程中,接受本发明片剂治疗的患者未发现有任何不良反应,由表1数据可见,本发明片剂对治疗结核性心包炎的总有效率达86.7%以上,是治疗结核性心包炎的安全有效药物,具有很好的临床意义。
6.临床个体病例
病例1:牛某某,男,28岁,男,患者一直发热、胸痛、心悸、咳嗽,并伴有严重的四肢乏力等症状,经检查发现胸腔有积液,后确诊为结核性心包炎,服用本发明实施例1制备的片剂2个疗程后,症状缓解,四肢活动正常,服用4个疗程后胸腔积液消除,继续服用2个疗程心脏异常消失,半年后回访未复发。
病例2:上官某,男,36岁,出现咳嗽、呼吸困难,食欲不佳,短期内明显消瘦,间歇性的出现心动过速、心绞痛,检查后确诊为结核性心包炎,服用本发明实施例2制备的片剂一个疗程,咳嗽减轻,呼吸正常,逐渐恢复食欲,接着服用三个疗程,临床症状消失,继续服用两个疗程后未见心动过速、心绞痛,一年后回访未复发。
病例3:宋某,男,42岁,由于体型较胖,患者经常性出现胸闷、气短加剧胸部紧张烦闷感,反复发作,因肝脏肿大、下肢水肿多次住院治疗,效果不佳,后复发次数逐渐增多,经确诊为结核性心包炎,服用本发明实施例3制备的片剂2个疗程后,胸闷气短症状消失,继续服用了两个疗程,下肢水肿减弱,继续服用2个疗程后,心电图检查正常,肝脏未见异常,随访一年未复发。
尽管已参照其具体实施方案描述和阐明了本发明,但本领域技术人员会认识到,可以在不背离本发明的精神和范围的情况下对其作出各种改变、修改和取代。例如,由于被治疗特定病症的人的响应能力的变化,如上阐述的优选剂量以外的有效剂量可能适用。同样地,观察到的药理学响应可能根据和依赖所选特定活性化合物或是否存在药用载体以及制剂类型和所用给药模式而变,根据本发明的目的和实践预想到结果中的这类预期变化或差异。因此,本发明意在仅受下列权利要求的范围限制且这些权利要求应在合理的程度上尽可能广义地解释。
Claims (7)
1.一种治疗结核性心包炎的片剂,其特征在于,所述片剂是主要由以下重量份的成分组成:曲安西龙3-5份、烟酰胺8-12份、多巴9-14份、牡荆素12-15份、白杨素8-10份、天冬酰胺5-8份、琥珀酸6-10份、核黄素1-3份、棉子糖12-18份、可待因2-5份、马兜铃酸3-8份、香柑内酯6-12份、异黄酮0.5-1.5份、脱氧核苷酸0.8-1.6份、核糖核酸酶0.1-0.3份、脂溶性维生素3-8份、L-阿拉伯糖7-16份;所述片剂还包括辅料:填充剂110-150份、崩解剂18-26份、粘合剂30-50份、润滑剂8-12份。
2.如权利要求1所述的一种治疗结核性心包炎的片剂,其特征在于,所述的白杨素制备方法为:取新鲜山白松的心木清洗干净后,干燥使其水分含量低于3%,粉碎过20-30目筛得到粗粉,将粗粉置于提取器中,加入粗粉重量0.6%-0.9%的生物酶,同时加入粗粉重量6-8倍量的质量浓度为50-70%的乙醇,在pH值4-5,温度为36-45℃的条件下酶解2-3h,酶解完后将提取器中混合液进行超声提取45-60min,超声提取频率为25-35KHz,温度条件36-48℃过滤提取液后将得到的滤液减压浓缩成浸膏,给浸膏中加入3-5倍量的蒸馏水进行溶解,使用大孔吸附树脂吸附,再用5-8倍量的质量浓度为60-80%的乙醇溶液洗脱,将洗脱液通过溶液泵以高压状态急速喷入结晶釜内进行结晶,收集析出晶体即得到白杨素。
3.如权利要求1所述的一种治疗结核性心包炎的片剂,其特征在于,所述的填充剂为微晶纤维素、乳糖或倍他环糊精中的任意一种或两种以上的任意组合。
4.如权利要求1所述的一种治疗结核性心包炎的片剂,其特征在于,所述的崩解剂为羧甲基淀粉钠、低取代羟丙基纤维素或交联羧甲基纤维素钠中的任意一种或两种以上的任意组合。
5.如权利要求1所述的一种治疗结核性心包炎的片剂,其特征在于,所述的粘合剂为预交化淀粉、阿拉伯胶或羟丙基纤维素中的任意一种或两种以上的任意组合。
6.如权利要求1所述的一种治疗结核性心包炎的片剂,其特征在于,所述的润滑剂为硬脂酸镁、二氧化硅或滑石粉中的任意一种或两种以上的任意组合。
7.如权利要求1-6任意一项所述的一种治疗结核性心包炎的片剂,其特征在于制备方法为:
步骤一:取新鲜山白松的心木清洗干净后,干燥使其水分含量低于3%,粉碎过20-30目筛得到粗粉,将粗粉置于提取器中,加入粗粉重量0.6%-0.9%的生物酶,同时加入粗粉重量6-8倍量的质量浓度为50-70%的乙醇,在pH值4-5,温度为36-45℃的条件下酶解2-3h,酶解完后将提取器中混合液进行超声提取45-60min,超声提取频率为25-35KHz,温度条件36-48℃过滤提取液后将得到的滤液减压浓缩成浸膏,给浸膏中加入3-5倍量的蒸馏水进行溶解,使用大孔吸附树脂吸附,再用5-8倍量的质量浓度为60-80%的乙醇溶液洗脱,将洗脱液通过溶液泵以高压状态急速喷入结晶釜内进行结晶,收集析出晶体即得到白杨素;
步骤二:将所述重量组份的曲安西龙、烟酰胺、多巴、牡荆素、白杨素、天冬酰胺、琥珀酸、核黄素、棉子糖、可待因、马兜铃酸、香柑内酯、异黄酮、脱氧核苷酸、核糖核酸酶、脂溶性维生素、L-阿拉伯糖使用机械搅拌,置于搅拌机以120-180r/min,搅拌30-45min后得到混合药粉,再将混合药粉研磨粉碎,过200-300目筛,制成混合药物细粉,备用;
步骤三:将所述重量组份的粘合剂和纯化水按照1:4-6的重量比混合溶解配制成粘合剂溶液,备用;
步骤四:将步骤二制备的混合药物细粉和所述重量组份的填充剂混合均匀,加入步骤三制备的粘合剂溶液中,制备成湿颗粒,再将湿颗粒干燥并整粒得到干颗粒,干燥温度35-45℃,给干颗粒中加入所述重量组份的崩解剂、润滑剂,混合均匀后压制成片剂,即制备治疗结核性心包炎的片剂。
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