CN106619650A - 一种治疗慢性肾小球炎的复合制剂 - Google Patents
一种治疗慢性肾小球炎的复合制剂 Download PDFInfo
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Abstract
本发明公开了一种治疗慢性肾小球炎的复合制剂,所述治疗慢性肾小球炎的复合制剂,按照重量份的主要原料为:三尖杉酯碱18‑30份、香风草甙5‑15份、柯诺辛8‑12份、降二氢辣椒碱5‑12份、硫秋水仙苷4‑8份、氯化琥珀胆碱2‑6份、薄荷醇2‑8份、泛酸钙7‑14份、甲基黄连碱5‑18份。本发明药物根据慢性肾小球炎的认识机理对原料成分进行严格挑选,从而达到全面康复的目的,具有起效快、作用稳定、携带服用方便、长期服用无毒副作用的特点。
Description
技术领域
本发明涉及一种医药制备领域,具体是一种治疗慢性肾小球炎的复合制剂。
背景技术
慢性肾小球肾炎(chronic glomerulonephritis),简称为慢性肾炎,系指蛋白尿、血尿、高血压、水肿为基本临床表现,起病方式各有不同,病情迁延,病变缓慢进展,以致不同程度肾功能减退,最终发展为慢性肾衰竭的一组肾小球疾病。由于本组疾病的病理类型及病期不同,主要临床表现各不相同,疾病表现呈多样化。目前临床使用的治疗慢性肾小球肾炎的中成药分为两大类:一为单体成分如冬虫夏草菌丝制剂;另一类为中药复方如复方肾炎片等等。前一类主要对肾脏局部损伤起保护作用,无法针对慢性肾脏疾病患者的临床表现进行治疗;后一类对慢性肾脏病患者的临床表现有一定作用,但慢性肾脏病肾脏局部的病理改变多为活动性病变与静止性病变并存,活动性病变得不到控制,临床表现虽为慢性过程,而肾脏本身的病变将进行性进展直至发展到尿毒症。
发明内容
本发明的目的在于提供一种治疗慢性肾小球炎的复合制剂,以解决上述背景技术中提出的问题。
为实现上述目的,本发明提供如下技术方案:
一种治疗慢性肾小球炎的复合制剂,按照重量份的主要原料为:三尖杉酯碱18-30份、香风草甙5-15份、柯诺辛8-12份、降二氢辣椒碱5-12份、硫秋水仙苷4-8份、氯化琥珀胆碱2-6份、薄荷醇2-8份、泛酸钙7-14份、甲基黄连碱5-18份。
作为本发明进一步的方案:所述治疗慢性肾小球炎的复合制剂,按照重量份的主要原料为:三尖杉酯碱21-27份、香风草甙8-12份、柯诺辛9-11份、降二氢辣椒碱7-11份、硫秋水仙苷4-8份、氯化琥珀胆碱2-6份、薄荷醇2-8份、泛酸钙8-12份、甲基黄连碱9-14份。
作为本发明进一步的方案:所述治疗慢性肾小球炎的复合制剂,按照重量份的主要原料为:三尖杉酯碱25份、香风草甙10份、柯诺辛10份、降二氢辣椒碱9份、硫秋水仙苷6份、氯化琥珀胆碱4份、薄荷醇5份、泛酸钙10份、甲基黄连碱12份。
一种治疗慢性肾小球炎的复合制剂的制备方法,具体步骤为:
首先,在医药级洁净区内,按上述计量比称取三尖杉酯碱、香风草甙、柯诺辛、降二氢辣椒碱、硫秋水仙苷、氯化琥珀胆碱、薄荷醇、泛酸钙、甲基黄连碱,过筛,机械混匀后添加超纯水,放置制药混合机中,混合4-8min,控制RSD≤5%,混合后压片并低温干燥,温度控制在4-8℃,包装即得治疗慢性肾小球炎的复合制剂。
作为本发明进一步的方案:具体步骤中混合6min。
与现有技术相比,本发明的有益效果是:
本发明药物根据慢性肾小球炎的认识机理对原料成分进行严格挑选,从而达到全面康复的目的,具有起效快、作用稳定、携带服用方便、长期服用无毒副作用的特点。
具体实施方式
下面将结合本发明实施例,对本发明实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例仅仅是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。
实施例1
一种治疗慢性肾小球炎的复合制剂,按照重量份的主要原料为:三尖杉酯碱18份、香风草甙5份、柯诺辛8份、降二氢辣椒碱5份、硫秋水仙苷4份、氯化琥珀胆碱2份、薄荷醇2份、泛酸钙7份、甲基黄连碱5份。
一种治疗慢性肾小球炎的复合制剂的制备方法,具体步骤为:
首先,在医药级洁净区内,按上述计量比称取三尖杉酯碱、香风草甙、柯诺辛、降二氢辣椒碱、硫秋水仙苷、氯化琥珀胆碱、薄荷醇、泛酸钙、甲基黄连碱,过筛,机械混匀后添加超纯水,放置制药混合机中,混合4min,控制RSD≤5%,混合后压片并低温干燥,温度控制在4℃,包装即得治疗慢性肾小球炎的复合制剂。
实施例2
一种治疗慢性肾小球炎的复合制剂,按照重量份的主要原料为:三尖杉酯碱21份、香风草甙8份、柯诺辛9份、降二氢辣椒碱7份、硫秋水仙苷4份、氯化琥珀胆碱2份、薄荷醇2份、泛酸钙8份、甲基黄连碱9份。
一种治疗慢性肾小球炎的复合制剂的制备方法,具体步骤为:
首先,在医药级洁净区内,按上述计量比称取三尖杉酯碱、香风草甙、柯诺辛、降二氢辣椒碱、硫秋水仙苷、氯化琥珀胆碱、薄荷醇、泛酸钙、甲基黄连碱,过筛,机械混匀后添加超纯水,放置制药混合机中,混合4min,控制RSD≤5%,混合后压片并低温干燥,温度控制在4℃,包装即得治疗慢性肾小球炎的复合制剂。
实施例3
一种治疗慢性肾小球炎的复合制剂,按照重量份的主要原料为:三尖杉酯碱25份、香风草甙10份、柯诺辛10份、降二氢辣椒碱9份、硫秋水仙苷6份、氯化琥珀胆碱4份、薄荷醇5份、泛酸钙10份、甲基黄连碱12份。
一种治疗慢性肾小球炎的复合制剂的制备方法,具体步骤为:
首先,在医药级洁净区内,按上述计量比称取三尖杉酯碱、香风草甙、柯诺辛、降二氢辣椒碱、硫秋水仙苷、氯化琥珀胆碱、薄荷醇、泛酸钙、甲基黄连碱,过筛,机械混匀后添加超纯水,放置制药混合机中,混合6min,控制RSD≤5%,混合后压片并低温干燥,温度控制在6℃,包装即得治疗慢性肾小球炎的复合制剂。
实施例4
一种治疗慢性肾小球炎的复合制剂,按照重量份的主要原料为:三尖杉酯碱27份、香风草甙12份、柯诺辛11份、降二氢辣椒碱11份、硫秋水仙苷8份、氯化琥珀胆碱6份、薄荷醇8份、泛酸钙12份、甲基黄连碱14份。
一种治疗慢性肾小球炎的复合制剂的制备方法,具体步骤为:
首先,在医药级洁净区内,按上述计量比称取三尖杉酯碱、香风草甙、柯诺辛、降二氢辣椒碱、硫秋水仙苷、氯化琥珀胆碱、薄荷醇、泛酸钙、甲基黄连碱,过筛,机械混匀后添加超纯水,放置制药混合机中,混合8min,控制RSD≤5%,混合后压片并低温干燥,温度控制在8℃,包装即得治疗慢性肾小球炎的复合制剂。
实施例5
一种治疗慢性肾小球炎的复合制剂,按照重量份的主要原料为:三尖杉酯碱30份、香风草甙15份、柯诺辛12份、降二氢辣椒碱12份、硫秋水仙苷8份、氯化琥珀胆碱6份、薄荷醇8份、泛酸钙14份、甲基黄连碱18份。
一种治疗慢性肾小球炎的复合制剂的制备方法,具体步骤为:
首先,在医药级洁净区内,按上述计量比称取三尖杉酯碱、香风草甙、柯诺辛、降二氢辣椒碱、硫秋水仙苷、氯化琥珀胆碱、薄荷醇、泛酸钙、甲基黄连碱,过筛,机械混匀后添加超纯水,放置制药混合机中,混合8min,控制RSD≤5%,混合后压片并低温干燥,温度控制在8℃,包装即得治疗慢性肾小球炎的复合制剂。
药理学试验
1、慢性毒性试验
以本发明实施例3制得的复合制剂为试验,采用灌胃给药方式,在24h内连续给药3次,每次间隔6h,每次给药500mg/kg药量,每天累积药物总量达1500mg药物/kg,相当于人临床用量的100倍。给药后7d内,小鼠活动、进食、排泄均正常,生长良好,毛色光亮,其平均体重均随实验时间的延长而增加。第8d处死后解剖每只小鼠,肉眼观察心、肝、脾、肺、肾、脑、胸腺、胃、肠等均未发现颜色及形态异常,未能测出半数致死量(LD50)。结果表明:本发明复合制剂无慢性毒性反应。
2、长期毒性试验
以本发明实施例3制得的复合制剂为试验,采用灌胃给药方式,将本发明复合制剂分为低剂量、中剂量、高剂量三组,各组的药物用量分别为150、300、450mg药物/kg/d,相当于临床剂量的10、20、30倍。灌胃给药24周后,本发明药物对动物的一般状况、血液学指标、血液生化指标均无明显的影响,系统解剖、脏器系数及组织病理学检查也未发现异常病理改变。停药2周也未见明显改变。结果表明:本发明复合制剂在长期毒性试验中,未发现明显毒性反应和延迟毒性反应。可见,本发明复合制剂无毒性反应,长期用药安全可靠。
3、临床试验
收治符合西医诊断标准的患者,共92例患者,男性43例,女性49例,平均年龄42.5岁,平均病程1.7年,尿蛋白量1.32±0.63g/d,血尿素氮7.64±1.22mmol/L,血肌酐168.41±51.32μmol/L。
西医诊断标准:(1)起病缓慢,病情迁延,时轻时重,肾功能逐步减退,血尿素氮、血肌酐轻度升高;(2)有不同程度的蛋白尿(尿蛋白定量>1g/24h)、血尿、水肿及高血压;(3)病程中可因呼吸道感染等原因诱发慢性发作,出现类似慢性肾炎的表现。
疗效判断标准:1.完全缓解:浮肿、腰痛完全消失,尿蛋白持续阴性,24小时尿蛋白定量持续小于0.3g,肾功能正常;2.基本缓解:浮肿与腰痛基本消失,尿蛋白持续减少50%以上,肾功能正常或基本正常(与正常值相差不超过15%);3.有效:水肿与腰痛明显好转,24小时尿蛋白量持续减少25%~49%,肾功能正常或有改善;4.无效:临床表现现与实验室检查均无明显改善或反而加重者。
治疗效果:92例患者采用本发明实施例3制备的复合制剂进行治疗,每天服用15mg/kg,治疗30天后,尿蛋白量0.54±0.82g/d,血尿素氮7.04±1.32mmol/L,血肌酐121.65±69.29μmol/L,与治疗前有显著性差异;完全缓解45例,基本缓解21例,有效23例,无效3例,总有效率96.7%;且在整个治疗期间均未出现不良反应。
对于本领域技术人员而言,显然本发明不限于上述示范性实施例的细节,而且在不背离本发明的精神或基本特征的情况下,能够以其他的具体形式实现本发明。因此,无论从哪一点来看,均应将实施例看作是示范性的,而且是非限制性的,本发明的范围由所附权利要求而不是上述说明限定,因此旨在将落在权利要求的等同要件的含义和范围内的所有变化囊括在本发明内。
此外,应当理解,虽然本说明书按照实施方式加以描述,但并非每个实施方式仅包含一个独立的技术方案,说明书的这种叙述方式仅仅是为清楚起见,本领域技术人员应当将说明书作为一个整体,各实施例中的技术方案也可以经适当组合,形成本领域技术人员可以理解的其他实施方式。
Claims (5)
1.一种治疗慢性肾小球炎的复合制剂,其特征在于,按照重量份的主要原料为:三尖杉酯碱18-30份、香风草甙5-15份、柯诺辛8-12份、降二氢辣椒碱5-12份、硫秋水仙苷4-8份、氯化琥珀胆碱2-6份、薄荷醇2-8份、泛酸钙7-14份、甲基黄连碱5-18份。
2.根据权利要求1所述的治疗慢性肾小球炎的复合制剂,其特征在于,所述治疗慢性肾小球炎的复合制剂,按照重量份的主要原料为:三尖杉酯碱21-27份、香风草甙8-12份、柯诺辛9-11份、降二氢辣椒碱7-11份、硫秋水仙苷4-8份、氯化琥珀胆碱2-6份、薄荷醇2-8份、泛酸钙8-12份、甲基黄连碱9-14份。
3.根据权利要求1或2所述的治疗慢性肾小球炎的复合制剂,其特征在于,所述治疗慢性肾小球炎的复合制剂,按照重量份的主要原料为:三尖杉酯碱25份、香风草甙10份、柯诺辛10份、降二氢辣椒碱9份、硫秋水仙苷6份、氯化琥珀胆碱4份、薄荷醇5份、泛酸钙10份、甲基黄连碱12份。
4.一种如权利要求1-3任一所述的治疗慢性肾小球炎的复合制剂的制备方法,其特征在于,具体步骤为:
首先,在医药级洁净区内,按上述计量比称取三尖杉酯碱、香风草甙、柯诺辛、降二氢辣椒碱、硫秋水仙苷、氯化琥珀胆碱、薄荷醇、泛酸钙、甲基黄连碱,过筛,机械混匀后添加超纯水,放置制药混合机中,混合4-8min,控制RSD≤5%,混合后压片并低温干燥,温度控制在4-8℃,包装即得治疗慢性肾小球炎的复合制剂。
5.根据权利要求4所述的治疗慢性肾小球炎的复合制剂的制备方法,其特征在于,具体步骤中混合6min。
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