CN105832743A - 一种用于肾损伤后预防并发症的片剂 - Google Patents
一种用于肾损伤后预防并发症的片剂 Download PDFInfo
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- CN105832743A CN105832743A CN201610217825.8A CN201610217825A CN105832743A CN 105832743 A CN105832743 A CN 105832743A CN 201610217825 A CN201610217825 A CN 201610217825A CN 105832743 A CN105832743 A CN 105832743A
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
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Abstract
本发明公开了一种用于肾损伤后预防并发症的片剂及其制备方法，所述一种用于肾损伤后预防并发症的片剂主要是由以下成分组成：头孢霉素Ⅳ、氯美扎酮、薯蓣皂苷元、金丝桃甙、熊果酸、澳洲茄胺、挥发油、咖啡酸、槲皮素、芹菜素、鞣花酸、芸香甙、赖氨酸、丙氨酸、谷氨酰胺、羧甲基纤维素钠、填充剂、崩解剂、润滑剂、表面活性剂；本发明主要是针对肾损伤后的药物护理方面的研究，具有镇痛止血，消肿排脓，镇静，抗感染，增强机体免疫能力，补肾益肾的作用，从而降低肾损伤后出血，肾周围水肿，肾结石，慢性肾炎等并发症的概率，减轻患者痛苦，尽可能地保护人体肾脏。
Description
技术领域
本发明涉及护理用药技术领域，具体是涉及一种用于肾损伤后预防并发症的片剂。
背景技术
肾脏是人体的重要排泄器官，其主要功能是过滤形成尿并排出代谢废物，调节体内的电解质和酸碱平衡，肾脏位于腹膜后，位置较深，通常不易损伤，但是常因刀刺及枪弹伤而致开放性损伤，也可因腰部或上腹部的直接打击，或激烈的振荡致使肾实质损伤，称为闭合性损伤，由于肾脏血运丰富，一旦损伤常会合并伤，特别是肝、脾、胃肠道及胸部，且伤情重、休克发生率高，多有血尿、腰痛、腹部包块等症状，症状得以控制后若护理不好，所引发的各种并发症常会给患者增加更多的痛苦，常见并发症如继发性出血、尿外渗、肾周围脓肿、急性肾小管坏死、尿瘘等，晚期并发症包括高血压、肾积水、结石、慢性肾盂肾炎、慢性肾功衰竭、动静脉瘘、肾功能不全等。
目前对肾损伤的治疗包括手术治疗和非手术治疗，大部分患者可通过非手术治疗而痊愈，从而保留住肾脏，并通过临床护理使肾脏功能恢复正常，部分患者仍需手术治疗以免病症发展引起更严重的后果，术后仍需做好护理工作，以免引发感染，再次出血等症，加强对肾脏的营养，修护受损组织，使患者尽快康复，从而避免给患者以后的生活带来更多痛苦。本发明主要针对肾损伤患者预防并发症的研究，为患者减轻痛苦，使其快速康复。
发明内容
本发明的技术方案是，一种用于肾损伤后预防并发症的片剂，主要是由以下重量份的成分组成：头孢霉素Ⅳ0.6-1.4份、氯美扎酮0.2-0.8份、薯蓣皂苷元13-27份、金丝桃甙11.6-25.7份、熊果酸10.3-23.5份、澳洲茄胺8.9-21.1份、挥发油8.4-20.0份、咖啡酸7.4-18.2份、槲皮素6.6-17.2份、芹菜素6.1-16.1份、鞣花酸5.2-14.4份、芸香甙0.1-0.7份、赖氨酸0.008-0.016份、丙氨酸0.005-0.013份、谷氨酰胺0.004-0.012份、羧甲基纤维素钠30-58份、填充剂40-96份、崩解剂5-19份、润滑剂1-6份、表面活性剂1.5-3.3份。
进一步地，所述的挥发油是芳樟醇、柠檬烯、香叶醛以3:5:0.2的比例组成的组合物，具有抗菌，镇静，提高机体免疫能力的作用。
进一步地，将所述重量份的羧甲基纤维素钠加入到55-60℃的水中边搅拌边溶解，使其浓度达到2％即可，再向其中加入所述重量份的表面活性剂，制得含有表面活性剂的混合溶液。
进一步地，所述表面活性剂为聚山梨酯80，易溶于水，毒性小，可使药物在水中溶解度增加而更好地相溶。
一种用于肾损伤后预防并发症的片剂，它的制备方法为：
步骤一：将所述重量份的羧甲基纤维素钠加入到55-60℃的水中边搅拌边溶解，使其浓度达到2％即可，再向其中加入所述重量份的表面活性剂，制得含有表面活性剂的混合溶液，备用；
步骤二：将所述重量组份的头孢霉素Ⅳ、氯美扎酮、薯蓣皂苷元、金丝桃甙、熊果酸、澳洲茄胺、咖啡酸、槲皮素、芹菜素、鞣花酸、芸香甙、赖氨酸、丙氨酸、谷氨酰胺加入步骤一制得的混合溶液中，用搅拌机搅拌使药物之间更好相溶，再按片剂制备工艺加入填充剂制成软材，再用喷雾干燥制粒法制成干燥颗粒，并从干燥颗粒中筛出适量细粉与挥发油混合，再加入到干颗粒中整粒，整粒后置于混合桶中，同时加入崩解剂、润滑剂混合均匀，用压片机压片，即为所述的用于肾损伤后预防并发症的片剂。
进一步地，所述填充剂为：乳糖，性质稳定，可压性好，且与大多数药物不起化学反应，是优良的填充剂。
进一步地，所述崩解剂为：交联PVP，流动性好，在有机溶剂和强酸强碱溶液中均不溶，在水中可迅速溶胀，崩解性能优越。
进一步地，所述润滑剂为：月桂醇硫酸镁，水溶性润滑剂，可改善片剂的崩解和药物的溶出。
本发明的有益效果是：本发明主要是针对肾损伤后的药物护理方面的研究，具有镇痛止血，消肿排脓，镇静，抗感染，增强机体免疫能力，补肾益肾的作用，通过多种成分合理配比，共同作用，制备工艺简单，药物副作用小，且能有效降低肾损伤后出血，肾周围水肿，肾结石，慢性肾炎等并发症的概率，稳定病人情绪，减轻患者痛苦，尽可能地保护人体肾脏。
本发明的注意事项：本发明过敏体质者、孕妇慎服，与其他治疗药物同时服用时应遵医嘱。
具体实施方式
实施例1：
一种用于肾损伤后预防并发症的片剂，主要是由以下重量份的成分组成：头孢霉素Ⅳ0.6份、氯美扎酮0.2份、薯蓣皂苷元13份、金丝桃甙11.6份、熊果酸10.3份、澳洲茄胺8.9份、挥发油8.4份、咖啡酸7.4份、槲皮素6.6份、芹菜素6.1份、鞣花酸5.2份、芸香甙0.1份、赖氨酸0.008份、丙氨酸0.005份、谷氨酰胺0.004份、羧甲基纤维素钠30份、填充剂40份、崩解剂5份、润滑剂1份、表面活性剂1.5份。
其中，所所述的挥发油是芳樟醇、柠檬烯、香叶醛以3:5:0.2的比例组成的组合物，具有抗菌，镇静，提高机体免疫能力的作用；所述表面活性剂为聚山梨酯80，易溶于水，毒性小，可使药物在水中溶解度增加而更好地相溶；所述填充剂为：乳糖，性质稳定，可压性好，且与大多数药物不起化学反应，是优良的填充剂；所述崩解剂为：交联PVP，流动性好，在有机溶剂和强酸强碱溶液中均不溶，在水中可迅速溶胀，崩解性能优越；所述润滑剂为：月桂醇硫酸镁，水溶性润滑剂，可改善片剂的崩解和药物的溶出。
一种用于肾损伤后预防并发症的片剂，它的制备方法为：
步骤一：将所述重量份的羧甲基纤维素钠加入到55℃的水中边搅拌边溶解，使其浓度达到2％即可，再向其中加入所述重量份的表面活性剂，制得含有表面活性剂的混合溶液，所述表面活性剂为聚山梨酯80，易溶于水，毒性小，可使药物在水中溶解度增加而更好地相溶，备用；
步骤二：将所述重量组份的头孢霉素Ⅳ、氯美扎酮、薯蓣皂苷元、金丝桃甙、熊果酸、澳洲茄胺、咖啡酸、槲皮素、芹菜素、鞣花酸、芸香甙、赖氨酸、丙氨酸、谷氨酰胺加入步骤一制得的混合溶液中，用搅拌机搅拌使药物之间更好相溶，再按片剂制备工艺加入填充剂制成软材，再用喷雾干燥制粒法制成干燥颗粒，并从干燥颗粒中筛出适量细粉与挥发油混合，再加入到干颗粒中整粒，整粒后置于混合桶中，同时加入崩解剂、润滑剂混合均匀，用压片机压片，即为所述的用于肾损伤后预防并发症的片剂。
实施例2：
一种用于肾损伤后预防并发症的片剂，主要是由以下重量份的成分组成：头孢霉素Ⅳ1.0份、氯美扎酮0.5份、薯蓣皂苷元20份、金丝桃甙18.65份、熊果酸16.9份、澳洲茄胺15份、挥发油14.2份、咖啡酸12.8份、槲皮素11.9份、芹菜素11.1份、鞣花酸9.8份、芸香甙0.4份、赖氨酸0.012份、丙氨酸0.009份、谷氨酰胺0.008份、羧甲基纤维素钠44份、填充剂68份、崩解剂12份、润滑剂3.5份、表面活性剂2.4份。
其中，所所述的挥发油是芳樟醇、柠檬烯、香叶醛以3:5:0.2的比例组成的组合物，具有抗菌，镇静，提高机体免疫能力的作用；所述表面活性剂为聚山梨酯80，易溶于水，毒性小，可使药物在水中溶解度增加而更好地相溶；所述填充剂为：乳糖，性质稳定，可压性好，且与大多数药物不起化学反应，是优良的填充剂；所述崩解剂为：交联PVP，流动性好，在有机溶剂和强酸强碱溶液中均不溶，在水中可迅速溶胀，崩解性能优越；所述润滑剂为：月桂醇硫酸镁，水溶性润滑剂，可改善片剂的崩解和药物的溶出。
一种用于肾损伤后预防并发症的片剂，它的制备方法为：
步骤一：将所述重量份的羧甲基纤维素钠加入到57.5℃的水中边搅拌边溶解，使其浓度达到2％即可，再向其中加入所述重量份的表面活性剂，制得含有表面活性剂的混合溶液，所述表面活性剂为聚山梨酯80，易溶于水，毒性小，可使药物在水中溶解度增加而更好地相溶，备用；
步骤二：将所述重量组份的头孢霉素Ⅳ、氯美扎酮、薯蓣皂苷元、金丝桃甙、熊果酸、澳洲茄胺、咖啡酸、槲皮素、芹菜素、鞣花酸、芸香甙、赖氨酸、丙氨酸、谷氨酰胺加入步骤一制得的混合溶液中，用搅拌机搅拌使药物之间更好相溶，再按片剂制备工艺加入填充剂制成软材，再用喷雾干燥制粒法制成干燥颗粒，并从干燥颗粒中筛出适量细粉与挥发油混合，再加入到干颗粒中整粒，整粒后置于混合桶中，同时加入崩解剂、润滑剂混合均匀，用压片机压片，即为所述的用于肾损伤后预防并发症的片剂。
实施例3：
一种用于肾损伤后预防并发症的片剂，主要是由以下重量份的成分组成：头孢霉素Ⅳ1.4份、氯美扎酮0.8份、薯蓣皂苷元27份、金丝桃甙25.7份、熊果酸23.5份、澳洲茄胺21.1份、挥发油20.0份、咖啡酸18.2份、槲皮素17.2份、芹菜素16.1份、鞣花酸14.4份、芸香甙0.7份、赖氨酸0.016份、丙氨酸0.013份、谷氨酰胺0.012份、羧甲基纤维素钠58份、填充剂96份、崩解剂19份、润滑剂6份、表面活性剂3.3份。
其中，所所述的挥发油是芳樟醇、柠檬烯、香叶醛以3:5:0.2的比例组成的组合物，具有抗菌，镇静，提高机体免疫能力的作用；所述表面活性剂为聚山梨酯80，易溶于水，毒性小，可使药物在水中溶解度增加而更好地相溶；所述填充剂为：乳糖，性质稳定，可压性好，且与大多数药物不起化学反应，是优良的填充剂；所述崩解剂为：交联PVP，流动性好，在有机溶剂和强酸强碱溶液中均不溶，在水中可迅速溶胀，崩解性能优越；所述润滑剂为：月桂醇硫酸镁，水溶性润滑剂，可改善片剂的崩解和药物的溶出。
一种用于肾损伤后预防并发症的片剂，它的制备方法为：
步骤一：将所述重量份的羧甲基纤维素钠加入到60℃的水中边搅拌边溶解，使其浓度达到2％即可，再向其中加入所述重量份的表面活性剂，制得含有表面活性剂的混合溶液，所述表面活性剂为聚山梨酯80，易溶于水，毒性小，可使药物在水中溶解度增加而更好地相溶，备用；
步骤二：将所述重量组份的头孢霉素Ⅳ、氯美扎酮、薯蓣皂苷元、金丝桃甙、熊果酸、澳洲茄胺、咖啡酸、槲皮素、芹菜素、鞣花酸、芸香甙、赖氨酸、丙氨酸、谷氨酰胺加入步骤一制得的混合溶液中，用搅拌机搅拌使药物之间更好相溶，再按片剂制备工艺加入填充剂制成软材，再用喷雾干燥制粒法制成干燥颗粒，并从干燥颗粒中筛出适量细粉与挥发油混合，再加入到干颗粒中整粒，整粒后置于混合桶中，同时加入崩解剂、润滑剂混合均匀，用压片机压片，即为所述的用于肾损伤后预防并发症的片剂。
本发明片剂在肾损伤后预防并发症中的应用：
一、动物试验：
1.实验方法：选取60只健康SD大鼠，随机分成三组，一组为空白对照组，两组为实验组，分别为实验a组，实验b组，试验期间，给空白对照组大鼠进行生理盐水喂养，给实验a组大鼠灌服本发明实施例2制备的片剂，给实验b组大鼠灌服6倍量的本发明实施例3制备的片剂，连服一周，记录大鼠每天的身体指标。
2.结论：通过大鼠各项指标分析，显示其体重增加，未见任何毒性反应，解刨后未见有任何用药造成的机体损伤，说明本发明安全，毒副作用小。
二、临床资料：
1、发明人选取90例肾损伤患者，男50例，女40例，年龄在25-70岁之间，症状有血尿，疼痛，肾周围血肿，高热等症状。发明人将其随机分成两组，一组对照组，一组实验组，两组在预防并发症研究中，给实验组患者服用本发明实施例2制备的片剂，对照组服用普通抗炎止血的药物。
2、疗效标准：
(1)痊愈：症状消失，尿量正常，经过观察后未见有严重并发症出现；
(2)有效：症状有所好转，血尿仍存在异常，有少量并发症出现；
(3)无效：服药后病情无任何变化，出现并发症。
3、治疗统计结果：
两组疗效比较
| 组别 | 病例人数 | 痊愈 | 有效 | 无效 | 总有效率％ |
| 实验组 | 45 | 35 | 8 | 2 | 95.6 |
| 对照组 | 45 | 23 | 11 | 11 | 75.6 |
4、结论：由上表可看出，本发明的用于肾损伤后预防并发症的片剂总有效率达到95.6％以上，安全，毒副作用小，适于临床推广。
三、临床个体病例：
病例1：张某，男，38岁，车祸导致肾脏由于猛烈撞击造成实质性损伤，有见内膜损伤及内膜下出血，经及时抢救治疗后转病房护理，使用本发明实施例1制备的片剂，症状得到好转，服用5天后检查，未见有任何并发症状，病人情绪良好。
病例2：李某，女，55岁，有肿瘤病史，无特殊原因出现腹痛，尿血等症，入院后检查为肾脏破裂，进行紧急处理后住院护理，服用本发明实施例2制备的片剂，出血消失，也未引发感染，继发肿瘤等症状，患者状况良好。
病例3：刘某某，男，42岁，不慎从楼梯上滑跌致使腰部受到硬物撞击而导致的肾损伤，入院后对病情进行观察，处理后药物护理，服用本发明实施例3制备的片剂，血尿症状消失，未见感染等症，服药5天后病情稳定。
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 (8)
1.一种用于肾损伤后预防并发症的片剂，其特征在于，主要是由以下重量份的成分组成：头孢霉素Ⅳ0.6-1.4份、氯美扎酮0.2-0.8份、薯蓣皂苷元13-27份、金丝桃甙11.6-25.7份、熊果酸10.3-23.5份、澳洲茄胺8.9-21.1份、挥发油8.4-20.0份、咖啡酸7.4-18.2份、槲皮素6.6-17.2份、芹菜素6.1-16.1份、鞣花酸5.2-14.4份、芸香甙0.1-0.7份、赖氨酸0.008-0.016份、丙氨酸0.005-0.013份、谷氨酰胺0.004-0.012份、羧甲基纤维素钠30-58份、填充剂40-96份、崩解剂5-19份、润滑剂1-6份、表面活性剂1.5-3.3份。
2.如权利要求1所述的一种用于肾损伤后预防并发症的片剂，其特征在于，所述的挥发油是芳樟醇、柠檬烯、香叶醛的组合物。
3.如权利要求1所述的一种用于肾损伤后预防并发症的片剂，其特征在于于，将所述重量份的羧甲基纤维素钠用水溶解后再向其中加入表面活性剂，制得含有表面活性剂的混合溶液。
4.如权利要求3所述的一种用于肾损伤后预防并发症的片剂，其特征在于，所述表面活性剂为聚山梨酯80。
5.如权利要求1至4任意一项所述的一种用于肾损伤后预防并发症的片剂，其特征在于，它的制备方法为：
步骤一：将所述重量份的羧甲基纤维素钠用水溶解后再向其中加表面活性剂，制得含有表面活性剂的混合溶液，备用；
步骤二：将所述重量组份的头孢霉素Ⅳ、氯美扎酮、薯蓣皂苷元、金丝桃甙、熊果酸、澳洲茄胺、咖啡酸、槲皮素、芹菜素、鞣花酸、芸香甙、赖氨酸、丙氨酸、谷氨酰胺加入步骤一制得的混合溶液中，用搅拌机搅拌使药物之间更好相溶，再按片剂制备工艺加入填充剂制成软材，再用喷雾干燥制粒法制成干燥颗粒，并从干燥颗粒中筛出适量细粉与挥发油混合，再加入到干颗粒中整粒，整粒后置于混合桶中，同时加入崩解剂、润滑剂混合均匀，用压片机压片，即为所述的用于肾损伤后预防并发症的片剂。
6.如权利要求1所述的一种用于肾损伤后预防并发症的片剂，其特征在于，所述填充剂为：乳糖。
7.如权利要求1所述的一种用于肾损伤后预防并发症的片剂，其特征在于，所述崩解剂为：交联PVP。
8.如权利要求1所述的一种用于肾损伤后预防并发症的片剂，其特征在于，所述润滑剂为：月桂醇硫酸镁。
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