CN115531482B - 人参固本口服液在制备低蛋白血症防治药物中的用途 - Google Patents
人参固本口服液在制备低蛋白血症防治药物中的用途 Download PDFInfo
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Abstract
本发明属于医药领域,涉及人参固本口服液在制备低蛋白血症防治药物中的用途,很好的解决了现阶段低蛋白血症治疗过程中出现的问题。通过具体实施例对人参固本口服液的药效进行研究,结果显示:人参固本口服液单用或者合用均能恢复异常的肾功能,显著增加肾病低蛋白血症模型大鼠的尿量,减少尿蛋白含量,增加血清总蛋白及白蛋白含量;可以改善肝功,升高血清总蛋白及白蛋白水平,对肝损伤引起的低蛋白血症具有显著的治疗作用;此外,对甲状腺功能异常导致的低蛋白血症亦具有显著的防治作用。人参固本口服液在对低蛋白血症进行治疗时具有疗效显著,作用广泛,无毒副作用,使用方便,价格低廉等优点,具有很大的临床应用价值。
Description
技术领域
本发明属于医药领域,涉及人参固本口服液的新用途,具体涉及人参固本口服液在制备低蛋白血症防治药物中的新用途。
背景技术
临床上通常将血浆总蛋白(total serum protein,TSP)的降低特别是血浆白蛋白(serum albumin,SAB)低于30g/L称为低蛋白血症,它不是一个独立的疾病而是各种疾病导致负氮平衡的结果。常见于肝脏疾病造成蛋白合成障碍,肾脏疾病造成蛋白丢失过多以及长期发热、恶性肿瘤引起的蛋白分解加速等。除有原发疾病的表现外,其主要临床表现是营养不良。血液中的蛋白质主要是血浆蛋白及红细胞所含的血红蛋白。血浆蛋白包括SAB、各种球蛋白、纤维蛋白原及少量结合蛋白如糖蛋白、脂蛋白等。SAB分子量较大,是维持胶体渗透压的主要成分,SAB减少时,有效渗透压减低,使组织间潴留过多的水分,出现水肿,浮肿严重时可出现胸水及腹水,性功能减退、闭经、骨质疏松、机体抵抗力低下等。血浆纤维蛋白原减少者可有出血倾向。目前临床上采用的治疗方法主要为静脉输注人SAB注射剂和氨基酸制剂;也可以按高蛋白饮食的食物疗法或采用综合氨基酸制剂给予口服治疗。但是,制备SAB的原料人血的来源和采集都很紧张,造成临床用SAB注射剂供不应求,价格昂贵,同时存在血液制剂可能混入细菌、病毒等一系列安全问题。由此看来寻找一种安全有效、价格低廉且使用方便的新药具有重要的现实意义。
此外,围手术期、老年人或长期卧床的慢性疾病的病人都可存在低蛋白血症的情形,并且一些危重病人的死亡发生率与低蛋白血症呈现正相关性。因此,寻找一种安全高效的低蛋白血症防治药物具有重要的的临床意义。
人参固本口服液由人参、地黄、茯苓、牡丹皮、熟地黄、山茱萸、山药、泽泻、天冬、麦冬制备而成。具有滋阴益气,固本培元的功效。用于阴虚气弱,虚劳咳嗽,心悸气短,骨蒸潮热,腰酸耳鸣,遗精盗汗,大便干燥。人参固本口服液为鲁南厚普制药有限公司的独家产品,批准文号为“国药准字Z10940013”。
发明内容
为解决现阶段低蛋白血症治疗过程中出现的问题,寻找一种安全有效、价格低廉且使用方便的新药,本发明提供了人参固本口服液在制备低蛋白血症防治药物中的用途。
本发明的发明目的是通过如下技术方案实现的:
实施例人参固本口服液对肾病低蛋白血症模型大鼠低蛋白血症的治疗作用研究结果显示:人参固本口服液单用或者合用均能恢复异常的肾功能,显著增加肾病大鼠模型的尿量,减少尿蛋白含量,增加血清总蛋白及白蛋白含量,明显改善模型大鼠的一般状况,减少腹水发生率,并且人参固本口服液与白蛋白合用效果显著好于单用白蛋白。
实施例人参固本口服液对CCl4诱导所致化学性肝损伤低蛋白血症的影响研究结果表明:人参固本口服液可以改善肝功,升高血清总蛋白及白蛋白水平,对肝损伤引起的低蛋白血症具有显著的治疗作用。
实施例人参固本口服液对甲状腺功能异常所致的低蛋白血症的治疗作用研究结果显示:人参固本口服液能显著升高甲状腺功能异常模型小鼠的血浆总蛋白水平,提示人参固本口服液对甲状腺功能异常导致的低蛋白血症具有显著的防治作用。
人参固本口服液在制备低蛋白血症防治药物中的用途。
人参固本口服液在防治低蛋白血症时可单用或者与低蛋白血症防治药物合用。
低蛋白血症防治药物为白蛋白或者其它对低蛋白血症具有防治作用的药物。
除上述实施例中所述的低蛋白血症类型外,人参固本口服液还对由蛋白质摄入不足,肿瘤、结核等病消耗过多或蛋白质丢失过多等原因引起的低蛋白血症具有显著的防治作用。
所述的蛋白质丢失过多除实施例中所述的肾脏疾病外还应包括失蛋白性胃肠病。
此外,人参固本口服液还对围手术期低蛋白血症及老年人低蛋白血症有显著的防治作用。
本发明中所述的人参固本口服液由人参、地黄、茯苓、牡丹皮、熟地黄、山茱萸、山药、泽泻、天冬、麦冬制备而成。
可将上述中药成分制备成口服制剂,优选地,口服制剂为片剂、颗粒剂、胶囊剂、口服液中的一种或多种,上述几种口服制剂均按普通口服制剂工艺制备。
本发明提供的人参固本口服液在对低蛋白血症进行防治时具有如下优势:
1.效果显著作用广泛
研究结果显示,单用或者合用人参固本口服液均能显著升高血清总蛋白及白蛋白含量,降低尿蛋白含量,并且对多种原因引起的低蛋白血症均具有显著的防治作用。
2.中药成分综合调理
人参固本口服液为纯中药成分,在纠正患者低蛋白血症状的同时可对机体起到综合调理的作用,对基础疾病具有显著的治疗作用。
3.价格低廉,使用方便,无毒副作用
与现阶段低蛋白血症的治疗药物相比,人参固本口服液使用方便,无毒副作用,并且具有很大的价格优势。
具体实施例
以下通过具体实施例进一步说明本发明的发明内容,但应该理解,本发明实施例并不以任何方式限制本发明。
实施例1人参固本口服液对肾病大鼠模型低蛋白血症的治疗作用
1.实验方法
1.1实验动物
健康雄性清洁级SD大鼠50只,体重180~200g。标准饲料喂养,适应环境1周后,供实验使用。
1.2分组及给药
大鼠清醒状态下,尾静脉一次性注射多柔比星7.5mg/kg构建肾病模型,正常对照组尾静脉注射相同量的生理盐水。将造模后大鼠随机分为4组:模型对照组、白蛋白组、人参固本口服液组及联合用药组,加正常对照组共5组。每组10只。造模前一天开始人参固本口服液组及联合用药组大鼠灌胃人参固本口服液,剂量为2mL,1次/d,至实验结束,共灌胃14d,模型对照组每日灌服2ml蒸馏水。自造模后第8天开始,白蛋白组及联合用药组大鼠尾静脉注射白蛋白0.2g(1ml),1次/d,共7d。造模后第15天,实验结束,取血并处死大鼠。
1.3观察指标和测定方法
(1)一般情况观察大鼠的精神状态、体重、体毛、饮水、活动和水肿情况。
(2)尿液检查各组大鼠均于实验第8天、第14天置于代谢笼中,收集24h尿液,检查尿量,每日抽检尿常规。
(3)血液生化检查实验第15天,大鼠在乙醚麻醉下心脏采血,使用AC一920全自动血液分析仪测定血清白蛋白、总胆固醇(Tch)、血清三酰甘油(TG)、总蛋白。
(4)肾脏形态学检查心脏采血后处死大鼠,取肾脏,以10%甲醛固定,石蜡包埋切片,进行HE染色,光学显微镜下观察肾脏组织的病理变化。
1.4统计学处理所有结果均以表示,采用SPSS13.0软件统计,数据处理采用方差分析。
2.实验结果
2.1一般情况
除正常对照组外,其余各组大鼠造模后均出现食量和尿量减少、腹泻、精神不振、体重减轻、喜蜷缩、体毛凌乱无光泽,活动迟缓等现象,其中人参固本口服液组及联合用药组上述症状明显轻于模型组及白蛋白组,并且人参固本口服液组及联合用药组的腹水发生率也明显低于模型组及白蛋白组。
2.2尿量检查
对造模前、造模后第8天和造模后第15天的各组大鼠分别收集并测量尿量,结果显示,造模前,各组大鼠24h尿量无显著性差异(P>0.05)。造模后第8天,与正常对照组相比,模型组及各给药组尿量均有极显著性差异(P<0.01),说明造模成功,与模型组相比,白蛋白组尿量无显著性差异,人参固本口服液组及联合用药组尿量均有显著性差异(P<0.05或P<0.01),说明人参固本口服液不论单用或者联用均能起到延缓肾损伤进程进而防止低蛋白血症的发生,并且随着时间的延长人参固本口服液组及联合用药组的尿量与模型组差异更加显著;与白蛋白组相比,人参固本口服液及联合用药组分别具有显著性或极显著性差异(P<0.05或P<0.01),说明单用或者联用人参固本口服液在增加尿量方面效果均显著好于单用白蛋白;联合用药组尿量多于人参固本口服液组,但差异无统计学意义。具体结果见表1。
表1治疗前后各组大鼠尿量比较(n=10,V/mL)
组别 | 造模前 | 造模后第8天 | 造模后第15天 |
正常组 | 23.1±3.2 | 22.9±2.6 | 23.4±3.1 |
模型组 | 22.4±2.9 | 10.2±2.4## | 8.9±3.8## |
白蛋白组 | 23.6±2.4 | 9.8±2.7## | 14.3±3.1##﹩ |
人参固本口服液组 | 22.9±3.0 | 13.9±1.8##﹩β | 20.9±3.3﹩﹩ββ |
联合用药组 | 24.2±2.7 | 15.5±2.4##﹩﹩ββ | 22.8±2.7﹩﹩ββ |
与正常组相比,##P<0.01;
与模型组相比,﹩P<0.05,﹩﹩P<0.01;
与白蛋白组相比,βP<0.05,ββP<0.01。
2.3尿蛋白检查
造模后第5天,除空白对照组外,各组大鼠尿常规检查出现蛋白阳性,并随造模天数增加呈进行性加剧,至造模后第8天,模型组及白蛋白组尿蛋白检查为+++,人参固本口服液及联合用药组尿蛋白检查结果为++,各组与空白对照组相比差异非常显著,提示造模成功。实验第15天,模型对照组及白蛋白组尿蛋白均为++++,人参固本口服液组和联合用药组均为+。由此可见,单用及联合应用人参固本口服液均可使大鼠蛋白排泄量明显减少。
2.4生化指标及肾功能检查结果
各组大鼠生化指标如表2所示,从表中可以看出,与正常对照组相比模型组各项指标均有极显著性差异(P<0.01),表明造模成功;与模型组相比,各治疗组白蛋白及总蛋白均具有极显著性差异(P<0.01),总胆固醇和三酰甘油具有显著性或极显著性差异(P<0.05或P<0.01);与白蛋白组相比,人参固本口服液及联合用药组白蛋白及总蛋白均无显著性差异,总胆固醇及三酰甘油均具有极显著性差异(P<0.01)。以上结果表明:单用或者合用人参固本口服液均能够增加血清白蛋白及总蛋白浓度,并且与白蛋白合用具有协同增效作用。
表2各组大鼠生化指标比较
与正常组相比,#P<0.01,##P<0.01;
与模型组相比,﹩P<0.05,﹩﹩P<0.01;
与白蛋白组相比,βP<0.01,ββP<0.01。
2.5肾脏形态学检查
(1)一般观察
肉眼观察各组大鼠肾脏无异常发现。
(2)病理学检查
正常对照组:未见异常。模型对照组:肾小球毛细血管壁变薄,上皮细胞增大,系膜细胞轻度增生,基膜增厚,毛细血管狭窄,部分闭塞,近曲小管上皮呈细胞内水肿及脂肪变性,少数近曲小管上皮细胞内玻璃样变性,肾小管内见蛋白管型。白蛋白组:基本同模型对照组。人参固本口服液组:肾小球毛细血管壁变薄较模型对照组轻,系膜细胞轻度增生,近曲小管上皮呈轻度细胞内水肿及脂肪变性。联合用药组的病理变化基本与人参固本口服液组相同。
实施例2人参固本口服液对CCl4诱导所致化学性肝损伤低蛋白血症的影响
1实验方法
1.1实验动物
SPF级雄性SD大鼠50只。体质量为180-250g。购回后适应性饲养7天,喂养在大鼠实验饲养室;温度:25±2℃;湿度:40-60%;光照:12小时明暗交替;给普通鼠粮,自由饮水。
1.2动物模型建立
从上述动物中随机选取10只作为正常对照组,其余40只按下述方法构建低蛋白血症模型,构建该模型分为诱导期和成模期。①诱导期:给受试动物饮用每升含0.35g PBS的水,时间为1周,激发肝脏酶的活性。②成模期:按1.25ml/kg的量腹腔注射40%CCl4橄榄油溶液,每周2次,连续4周;同时在饮用水中加入10%的食用乙醇为其惟一饮用水。第5周腹腔注射橄榄油中CCl4的浓度提高到50%,剂量仍为1.25ml/kg体重,每周2次,持续4周;同时饮用水中乙醇浓度提高到30%至实验结束。造模前检测总蛋白、白蛋白、谷丙转氨酶、总胆红素等指标做基础值。接受CCl48周后抽血检查上述指标,以白蛋白(SAB)低于30g/L为合格模型。
1.3分组给药
从上述造模成功的28只大鼠中随机选取20只分为模型组和人参固本口服液组,人参固本口服液组按2ml/kg的量灌胃给予人参固本口服液,模型组灌胃给予同体积的生理盐水,两组动物均每天一次,连续给药14天。
1.4血清酶学检测
用乙醚将SD大鼠浅麻醉,眼眶取血约2ml,3000转/分离心15分钟,留血清检测总蛋白、白蛋白、谷丙转氨酶、总胆红素等指标。
2.统计分析
实验结果以均数±标准差表示,用平均值的成对二样本分析进行给药前后t检验,以为P<0.05统计学差异具有显著性。
3实验结果
各组大鼠测定生化指标如表3所示,从表中可以看出:与正常组相比,模型组各项指标均具有显著性差异(P<0.01);与模型组相比,人参固本口服液组各项指标均具有显著性差异(P<0.01)。以上结果表明人参固本口服液可以改善肝功,升高血清总蛋白及白蛋白水平,对肝损伤引起的低蛋白血症具有显著的治疗作用。
表3各组大鼠血清酶学检测结果
与正常组相比,##P<0.01;
与模型组相比,﹩﹩P<0.01。
实施例3人参固本口服液对甲状腺功能异常所致的低蛋白血症的治疗作用
1.实验动物及分组
30只小鼠按体重分为正常对照组,模型对照组及人参固本口服液组,人参固本口服液组按5ml/kg的量灌胃给予人参固本口服液,正常对照组及模型对照组灌胃给予等体积的生理盐水,各组每天均给药两次,给药第10天模型对照组及人参固本口服液组按320mg/kg的量灌胃甲状腺素,每天一次,连续20天,造模期间继续给药,第30天晚禁食,第二天解剖取血,测定血浆总蛋白含量。
2.数据统计
实验结果以均数±标准差表示,用平均值的成对二样本分析进行给药前后t检验,以为P<0.05统计学差异具有显著性。
3.实验结果
各组小鼠血浆总蛋白含量如表4所示,从表中可以看出:与正常组相比,模型组血浆总蛋白显著降低,差异具有统计学意义(P<0.01),表明造模成功;与模型组相比,人参固本口服也组血浆总蛋白显著升高,差异具有统计学意义(P<0.01),说明人参固本口服液对甲状腺功能异常导致的低蛋白血症具有显著的治疗作用。
表4各组小鼠血浆总蛋白含量
与正常组相比,##P<0.01;
与模型组相比,﹩﹩P<0.01。
Claims (6)
1.人参固本口服液作为唯一活性成份在制备低蛋白血症防治药物中的用途。
2.如权利要求1所述的用途,其特征在于,所述低蛋白血症为肾病低蛋白血症。
3.如权利要求1所述的用途,其特征在于,所述低蛋白血症为化学性肝损伤低蛋白血症。
4.如权利要求1所述的用途,其特征在于,所述低蛋白血症为甲状腺功能异常导致的低蛋白血症。
5.如权利要求1所述的用途,其特征在于,人参固本口服液中所含的中药成分可制备成口服制剂。
6.如权利要求1所述的用途,其特征在于,所述口服制剂为片剂、颗粒剂、胶囊剂或口服液。
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六味地黄丸对糖皮质激素治疗肾病综合征增效减毒作用的临床研究;胡顺金等;世界科学技术;第8卷(第2期);113-116 * |
参麦注射液对血液透析相关性低血压患者血压、血清白蛋白及透析充分性的影响;林玲等;《河北中医》;第41卷(第5期);706-709 * |
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