CN106692668A - 治疗艾滋病的药物组合物及其制备方法 - Google Patents
治疗艾滋病的药物组合物及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种治疗艾滋病痴呆综合征精神行为症状的药物组合物及其制备方法,本发明药物组合物是以桑椹子、西红花、山大颜、黄精、水绵、半胱氨酸、二油酰基卵磷脂为原料药,配比而成,可按常规制剂工艺制成各种剂型,治疗艾滋病痴呆综合征精神行为症状疗效显著。
Description
技术领域
本发明属于中药技术领域,尤其涉及一种治疗艾滋病痴呆综合征精神行为症状的药物组合物及其制备方法。
背景技术
我国艾滋病流行形势可概括为:全国 HIV 感染者报告人数已超过 4 万例,感染者估计人数已超过 100 万人,31 个省、自治区、直辖市已全部发现 HIV感染者,三种传播途径(性接触传播、经血传播及母婴传播)均已存在。全国艾滋病的流行经过散发期、局部流行期已转入广泛流行期。
现阶段,我国尚处于艾滋病低流行期,但艾滋病疫情增长趋势明显。近年来病人数量增加明显,面临艾滋病发病死亡高峰。全国31省报告在注射毒品者中发现艾滋病或 HIV 感染者,经性传播和母婴传播的比例上升,预示着疫情从高危人群向一般人群传播。由艾滋病引起的痴呆综合征精神行为给患者精神和生活带来了极大的不便,目前为止尚未发现一种有效治疗治疗艾滋病痴呆综合征精神行为症状的药物。
桑椹子:为桑科植物桑的果穗。5~6月当桑的果穗变红色时采收,晒干或蒸后晒干。【原形态】落叶灌木或小乔木,高3-15m。树皮灰白色,有条状浅裂;根皮黄棕色或红黄色,纤维性强。单叶互生;叶柄长l-2.5cm;叶片卵形或宽卵形,长5-20cm,宽4-10cm,先端锐尖或渐尖,基部圆形或近心形,边缘有粗锯齿或圆齿,有时有不规则的分裂,上面无毛,有光泽,下面脉上有短毛,腋间有毛,基出脉3条与细脉交织成网状,背面较明显;托叶披针形,早落。花单性,雌雄异株;雌、雄花序均排列成穗状葇荑花序,腋生;雌花序长l-2cm,被毛,总花梗长5-10mm;雄花序长1-2.5cm,下垂,略被细毛;雄花具花被片4,雄蕊4,中央有不育的雌蕊;雌花具花被片4,基部合生,柱头2裂。瘦果,多数密集成一卵圆形或长圆形的聚合果,长l-2.5cm,初时绿色,成熟后变肉质、黑紫色或红色。种子小。花期4-5月,果期5-6月。【性状】性状鉴别 聚花果由多数小瘦果集合而成,呈长圆形,长1-2cm,直径5-8mm。黄棕色、棕红色至暗紫色;有短果序梗。小瘦果卵圆形,稍扁,长约2mm,宽约1mm,外具肉质花被片4枚。气微,味微酸而甜。以个大、肉厚、包紫红、糖性大者为佳。【化学成分】果穗含糖,鞣酸(tannicacid),苹果酸( malicacid),维生素(vitamin)B1、B2和胡萝卜素(carotene);其脂类的脂肪酸主要为亚油酸(linoleic acid),油酸(oleic acid),软脂酸(palmitic acid),硬脂酸(stearic acid),尚有少量辛酸(caprylic acid),壬酸(pelargonic acid),癸酸(capricacid),肉豆蔻酸(myris-tic acid),亚麻酸(linolenic acid)等。精油中含桉叶素(cineole),牻儿醇(geraniol),芳樟醇乙酸酯(linalyl acetat),芳樟醇(linalool),樟脑(camphor),a-蒎烯(α-pinene)和柠檬烯(limonene)等;磷脂总含量0.41%,其中磷脂酸胆碱(phosphatidyl choline)32.15%,溶血磷脂酸胆碱(lysophosphatidy choline)19.30%,磷脂酸乙醇胺(phosphatidyl ethanolamine)15.91%,磷脂酸(phosphatidicacid)12.40%,磷脂酰肌醇(phosphatidyl inosi-tol)10.53%,双磷脂酰甘油(diphosphatidyl glycerol)6.59%。还含矢车菊素(cyanidin)和矢车菊甙(chrysanthemin)。【药理作用】1.增强免疫功能 小鼠α-醋酸萘酯酯酶(ANAE)阳性的T淋巴细胞和脾脏B淋巴细胞(溶血空斑形成细胞数),随年龄增长逐渐减少。给LACA小鼠每日灌服桑椹水煎剂12.5g(生药)/kg,连续10天,可显着增加不同年龄组小鼠的T淋巴细胞;但同剂量的桑椹水煎剂,仅可增加幼龄小鼠B淋巴细胞数,对1年以上的老龄小鼠无明显影响。应用3H-TdR掺入淋巴细胞转化试验表明,桑椹水煎剂有中度激发淋巴细胞转化的作用。2.对Na+-K+ -ATP酶活性的影响 给3-24月龄的BALb/c和LACA纯系小鼠每日灌服桑椹煎剂12.5g/kg,连续2星期。除24月龄老龄小鼠外,与同龄对照组比较均能显着降低红细胞膜Na+ -K+ -ATP酶活性。Na+ -K+ -ATP酶与机体释放能量、供Na+和K+的主动转运有关,桑椹子降低该酶的活性可能是其滋阴作用机制之一。【性味】甘;酸;性寒,【归经】肝;肾经,【功能主治】滋阴养血;生津;润肠。主肝肾不足和血虚精亏的头晕目眩;腰酸耳鸣;须发早白;失眠多梦;津伤口渴;消渴;肠燥便秘。【摘录】《中华本草》。
西红花:本品为鸢尾科番红花属植物番红花Crocus sativus L.的干燥柱头。【性状】本品呈线形,三分枝,长约3cm。暗红色,上部较宽而略扁平,顶端边缘显不整齐的齿状,内侧有一短裂隙,下端有时残留一小段黄色花柱。体轻,质松软,无油润光泽,干燥后质脆易断。气特异,微有剌激性,味微苦。【性味】甘,平。【归经】归心、肝经。【功能主治】活血化瘀,凉血解毒,解郁安神。用于经闭症瘕,产后瘀阻,温毒发斑,忧郁痞闷,惊悸发狂。【摘录】《中国药典》。
山大颜:为茜草科九节属植物九节Psychotria rubra (Lour.)Poir.,以根、叶入药。全年采集,鲜用或洗净切片晒干。【原形态】常绿灌木,高1~3米。幼枝近四棱形,老枝近圆形,光滑;枝有明显的节。叶对生,纸质,椭圆状矩圆形,长8~20厘米,宽2.5~5厘米,先端尖或短渐尖,基部渐窄,下面脉腋内有簇毛,边波状,干时红色;托叶宽,膜质,早落。秋季开花,聚伞圆锥花序顶生及腋生;萼截形;花冠漏斗状,钱绿色或白色,5裂,裂片外反,冠内喉部有白毛。核果近球形,长约6毫米,熟时红色,光滑。种子背面有纵沟。【化学成分】根显内酯、甾类、鞣质及有机酸的反应。【性味】苦,寒。【功能主治】清热解毒,消肿拔毒。根、叶:白喉,扁桃体炎,咽喉炎,痢疾,肠伤寒,胃痛,风湿骨痛;叶:外用治跌打肿痛,外伤出血,毒蛇咬伤,疮疡肿毒,下肢溃疡。【摘录】《全国中草药汇编》。
黄精:为百合科植物黄精、多花黄精和滇黄精的根茎。【性状】性状鉴别(1)黄精根茎结节状。一端粗,类圆盘状,一端渐细,圆柱状,全角略似鸡头,长2.5-11cm,粗端直径1-2cm,常有短分枝,上面茎痕明显,圆形,微凹,直径2-3mm,周围隐约可见环节;细端长2.5-4cm,直径5-10mm,环节明显,节间距离5-15mm,有较多须根或须根痕,直径约1mm。表面黄棕色,有的半透明,具皱纹;圆柱形处有纵行纹理。质硬脆或稍柔韧,易折断,断面黄白色,颗粒状,有企多黄棕色给管束小点。气微,味微甜。(2)多花黄精 根茎连珠状或块状,稍带圆柱形,直径2-3cm。每一结节上茎痕明显,圆盘状,直径约1cm。圆柱形处环节明显,有众多须根痕,直径约1mm。表面黄棕色,有细皱纹。质坚实,稍带柔韧,折断面颗粒状,有众多黄棕色维管束小点散列。气微,味微甜。(3)滇黄精 根茎肥厚,姜快状或连珠状,直往2-4cm或以上,每一结节有明显茎痕,圆盘状,稍凹陷,宜往5-8mm;须根痕多,常突出,宜径约2mm。表面黄白色至黄棕色,有明显环节及不规则纵皱。质实,较柔韧,不易折断,断面黄白色,平坦,颗粒状,有众多深色维管束小点。气微,味甜,有粘性。【化学成分】黄精的根状茎含甾体皂甙,已分离出2个呋甾烯醇型皂甙和2个螺甾烯醇型皂甙。属于前者的是:26-O-β-D-吡喃葡萄糖基-22-O-甲基-(25)S-呋甾-5-烯-3β,26-二醇3-O-β-石蒜四糖甙[26-O-β-D-glucopyranosyl-22-O-methyl-25(S)-furost-5-ene-3β,26-diol3-O-β-lycotetraoside]即西伯利亚蓼甙A(sibiricoside-A)和26-O-β-D-吡喃葡萄糖基-22-O-甲基-25(S)-呋甾-5-烯-3β,14α,26-三醇 3-O-β-石蒜四糖甙[26-O-β-D-glucopyranosyl-22-O-methyl-25(S)-fruost-5-ene-3β,14α,26-triol 3-O-β-lycotetraoside]即14α-羟基西伯利亚蓼甙A(14α-hydroxysibiricoside A);属于后者的是:[(23S,25R)螺甾-5-烯-3β,14α,23-三醇 3-O-β-lycotetraoside]即西伯利亚蓼甙 B(sibiricoside B)和新巴拉次薯蓣皂甙元-A3-O-β-石蒜四糖甙(neoprazerigenin A 3-O-β-lycotetraoside)。另含黄精多糖A、B、C,三者的相对分子质量均大于20万,均由葡萄糖(glucose)、甘露糖(mannose)和半乳糖醛酸(galacturonicacid)按照摩尔比6:26:1缩合而成;又含黄精低聚糖A、B、C,相对分子质量分别为1 630、862和472,系由果糖(fructose)与葡萄糖按摩尔比8:1、4:1和2:1缩合而成。【药理作用】1.抗病原微生物作用:体外试验表明、黄精水提出液(1 :320)对伤寒杆菌、金黄色葡萄球菌、抗酸杆菌有抑制作用,2%黄精在沙氏培养基内对常见致病真菌有不同程度的抑制作用。2.对血糖的影响:兔灌胃黄精浸膏,其血糖含量渐次增高,然后降低。黄精浸膏对肾上腺素引起的血糖过高呈显着抑制作用。3.抗疲劳作用:黄精煎剂17.67%浓度0.3ml/只腹腔注射,可延长小鼠游泳时间。4.抗氧化作用:黄精煎液20%浓度,13ml/只喂饮,连续27天,使小鼠肝脏超氧化物歧化酶(SOD)活性升高,心肌脂褐质含量降低。5.延缓衰老作用:黄精煎剂,20%浓度浸泡桑叶喂养家蚕,有延长家蚕幼虫期的作用。6.止血作用:黄精甲醇提取物40mg/只,正丁醇部分20mg/只,水层部分20mg/只,腹腔注射,对干冰-甲醇冷冻小鼠尾部1分钟,切尾法实验表明有止血作用,使小鼠出血量减少。7.对心血管作用:黄精水浸膏0.16-0.26g/kg 静脉注射,明显增加麻醉犬冠脉流量;1.5g/kg 静脉注射,对垂体后叶素引起的兔心肌缺血有对抗作用,对抗垂体后叶素引起的T波增高,促进T波异常提前恢复;12g/kg腹腔注射,可增强小鼠对缺氧的耐受力。8.抗病毒作用:黄精多糖0.2%眼液滴眼,6次/天,或加服黄精多糖10mg/kg,2次/天,对兔实验性单纯疱疹病毒性角膜炎均有治疗作用。9.其它作用:黄精煎剂6g/kg 灌胃,连续10天,可提高小鼠红细胞膜Na+,K+ -ATP酶活性。40%黄精醇提液0.3ml/只腹腔注射,能提高小鼠心肌、肝、脾组织细胞DNA对3H-TdR的掺入率。黄精煎剂0.5g/只灌胃使小鼠血浆cAMP,cGMP含量均下降,而以cGMP下降更多,因此cAMP/cGMP比值大于对照组,对脾组织cAMP,cGMP含量均上升,但cAMP/cGMP比值无明显变化。【性味】甘;平。【归经】脾;肺;肾经。【功能主治】养阴润肺;补脾益气,滋肾填精。主阴虚劳嗽;肺燥咳嗽;脾虚乏力;食少口干;消渴;肾亏腰膝酸软;阳痿遗精;耳鸣目暗;须发早白;体虚赢瘦;风癞癣疾。【摘录】《中华本草》。
水绵:为双星藻科植物光洁水绵、扭曲水绵和异形水绵等的藻体。春、夏间采收,洗净晒干。【性状】性状鉴别 干品呈不规则片状,草绿至墨绿色,大小厚薄不一,表面可见细丝。质绵软,易碎裂,断裂处呈毛茸状。鲜品聚集成团状,黄绿色,有多数小气泡,藻丝可见,摸之有滑腻感。质柔软,易扯断。气腥,味咸。【化学成分】异形水绵含五没食子酰葡萄糖(pentagalloylglucose),即3-O-双没食子酰-1,2,6-三没食子酰葡萄糖(3-O-digalloyl-1,2,6-trigalloylglucose)。【药理作用】异形水绵甲醇提取物具 α-葡萄糖甙酶抑制剂活性,且为竞争性抑制作用,还有一定α-淀粉酶抑制活性。该提取物还有抗菌活性,对金黄色葡萄球菌、大肠杆菌、产气杆菌、草分枝杆菌、黄色微球菌、普通变形菌、铜绿假单胞菌均有抑制作用。1.5μl 该提取物加入2.7cm2 液态单层Vero 细胞中,显一定细胞毒活性。【性味】甘;平;无毒。【功能主治】清热解毒;利湿。主丹毒;痈肿;漆疮;烫伤;泄泻。【摘录】《中华本草》。
半胱氨酸(Cysteine):分子式:C3H7NO2S,分子量:121.15,CAS登录号:4371-52-2。密度:1.335g/cm3(计算值)。熔点:225°C(实验值)。沸点:293.883°Cat 760 mmHg(计算值)。闪点:131.536°C(计算值)。
二油酰基卵磷脂(Dioleoyl-Lecithin):分子式:C44H84NO8P,分子量:786.12,CAS登录号:10015-85-7。
2个原料药的化学结构:
半胱氨酸(Cysteine) 二油酰基卵磷脂(Dioleoyl-Lecithin)。
发明内容
本发明的目的是克服背景技术的不足,提供一种有效治疗艾滋病痴呆综合征精神行为症状的药物组合物及其制备方法。
本发明是采用如下技术方案实现的:
制成该治疗艾滋病痴呆综合征精神行为症状的药物组合物的原料药的组成和重量份为:
桑椹子2360—2460重量份、西红花2140—2240重量份、山大颜1830—1930重量份、黄精890—990重量份、水绵4150—4250重量份、半胱氨酸96—106重量份、二油酰基卵磷脂67—77重量份。
优选的用于治疗艾滋病痴呆综合征精神行为症状的药物组合物,是由如下重量份的原料药组成:
桑椹子2410重量份、西红花2190重量份、山大颜1880重量份、黄精930重量份、水绵4200重量份、半胱氨酸101重量份、二油酰基卵磷脂72重量份。
一种治疗艾滋病痴呆综合征精神行为症状的药物组合物,其特征在于药物组合物可以采用制剂学的常规方法制备成片剂或胶囊剂或滴丸。
一种治疗艾滋病痴呆综合征精神行为症状的药物组合物,其特征在于药物组合物与化学药或中药组成的治疗艾滋病痴呆综合征精神行为症状药物。
一种治疗艾滋病痴呆综合征精神行为症状的药物组合物的制备方法,其特征在于按如下步骤制备:
原料药的组成和重量份为:桑椹子2360—2460重量份、西红花2140—2240重量份、山大颜1830—1930重量份、黄精890—990重量份、水绵4150—4250重量份、半胱氨酸96—106重量份、二油酰基卵磷脂67—77重量份;
制备方法:
(1)按原料药配比取桑椹子、西红花、山大颜、黄精、水绵、半胱氨酸、二油酰基卵磷脂,混匀,用重量百分比浓度36%乙醇作为溶剂,在59℃温浸提取,提取次数为9次,每次提取时间为24小时,每次溶剂用量为原料药总重量的44倍,滤过,得药渣A和提取液A,提取液A回收乙醇,浓缩至相对密度1.14,滤过,药液通过LSA-40大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度54%乙醇溶液洗脱LSA-40大孔吸附树脂柱,收集重量百分比浓度54%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物A;
(2)取步骤(1)药渣A,用重量百分比浓度58%乙醇作为溶剂,加热回流提取4次,每次提取时间为5小时,每次溶剂用量为药渣A重量的15倍,滤过,得药渣B和提取液B,提取液B回收乙醇,浓缩至相对密度1.15,滤过,药液通过DM11大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度65%乙醇溶液洗脱DM11大孔吸附树脂柱,收集重量百分比浓度65%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物B;
(3)将提取物A和提取物B混匀,即得药物组合物。
优选的一种治疗艾滋病痴呆综合征精神行为症状的药物组合物的制备方法,其特征在于按如下步骤制备:
原料药的组成和重量份为:桑椹子2410重量份、西红花2190重量份、山大颜1880重量份、黄精930重量份、水绵4200重量份、半胱氨酸101重量份、二油酰基卵磷脂72重量份;
制备方法:
(1)按原料药配比取桑椹子、西红花、山大颜、黄精、水绵、半胱氨酸、二油酰基卵磷脂,混匀,用重量百分比浓度36%乙醇作为溶剂,在59℃温浸提取,提取次数为9次,每次提取时间为24小时,每次溶剂用量为原料药总重量的44倍,滤过,得药渣A和提取液A,提取液A回收乙醇,浓缩至相对密度1.14,滤过,药液通过LSA-40大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度54%乙醇溶液洗脱LSA-40大孔吸附树脂柱,收集重量百分比浓度54%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物A;
(2)取步骤(1)药渣A,用重量百分比浓度58%乙醇作为溶剂,加热回流提取4次,每次提取时间为5小时,每次溶剂用量为药渣A重量的15倍,滤过,得药渣B和提取液B,提取液B回收乙醇,浓缩至相对密度1.15,滤过,药液通过DM11大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度65%乙醇溶液洗脱DM11大孔吸附树脂柱,收集重量百分比浓度65%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物B;
(3)将提取物A和提取物B混匀,即得药物组合物。
一种治疗艾滋病痴呆综合征精神行为症状的药物组合物的制备方法,其特征在于药物组合物可以采用制剂学的常规方法制备成片剂或胶囊剂或滴丸。
一种治疗艾滋病痴呆综合征精神行为症状的药物组合物的制备方法,其特征在于药物组合物与化学药或中药组成治疗艾滋病痴呆综合征精神行为症状药物。
具体实施方式
实施例1:治疗艾滋病痴呆综合征精神行为症状的药物组合物及其制备方法
治疗艾滋病痴呆综合征精神行为症状的药物组合物的原料药的组成和重量份为:桑椹子2410重量份、西红花2190重量份、山大颜1880重量份、黄精930重量份、水绵4200重量份、半胱氨酸101重量份、二油酰基卵磷脂72重量份;
制备方法:
(1)按原料药配比取桑椹子、西红花、山大颜、黄精、水绵、半胱氨酸、二油酰基卵磷脂,混匀,用重量百分比浓度36%乙醇作为溶剂,在59℃温浸提取,提取次数为9次,每次提取时间为24小时,每次溶剂用量为原料药总重量的44倍,滤过,得药渣A和提取液A,提取液A回收乙醇,浓缩至相对密度1.14,滤过,药液通过LSA-40大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度54%乙醇溶液洗脱LSA-40大孔吸附树脂柱,收集重量百分比浓度54%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物A;
(2)取步骤(1)药渣A,用重量百分比浓度58%乙醇作为溶剂,加热回流提取4次,每次提取时间为5小时,每次溶剂用量为药渣A重量的15倍,滤过,得药渣B和提取液B,提取液B回收乙醇,浓缩至相对密度1.15,滤过,药液通过DM11大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度65%乙醇溶液洗脱DM11大孔吸附树脂柱,收集重量百分比浓度65%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物B;
(3)将提取物A和提取物B混匀,即得药物组合物。
实施例2:治疗艾滋病痴呆综合征精神行为症状的药物组合物及其制备方法
治疗艾滋病痴呆综合征精神行为症状的药物组合物的原料药的组成和重量份为:桑椹子2360重量份、西红花2240重量份、山大颜1830重量份、黄精990重量份、水绵4150重量份、半胱氨酸106重量份、二油酰基卵磷脂67重量份;
制备方法:
(1)按原料药配比取桑椹子、西红花、山大颜、黄精、水绵、半胱氨酸、二油酰基卵磷脂,混匀,用重量百分比浓度36%乙醇作为溶剂,在59℃温浸提取,提取次数为9次,每次提取时间为24小时,每次溶剂用量为原料药总重量的44倍,滤过,得药渣A和提取液A,提取液A回收乙醇,浓缩至相对密度1.14,滤过,药液通过LSA-40大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度54%乙醇溶液洗脱LSA-40大孔吸附树脂柱,收集重量百分比浓度54%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物A;
(2)取步骤(1)药渣A,用重量百分比浓度58%乙醇作为溶剂,加热回流提取4次,每次提取时间为5小时,每次溶剂用量为药渣A重量的15倍,滤过,得药渣B和提取液B,提取液B回收乙醇,浓缩至相对密度1.15,滤过,药液通过DM11大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度65%乙醇溶液洗脱DM11大孔吸附树脂柱,收集重量百分比浓度65%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物B;
(3)将提取物A和提取物B混匀,即得药物组合物。
实施例3:治疗艾滋病痴呆综合征精神行为症状的药物组合物及其制备方法
治疗艾滋病痴呆综合征精神行为症状的药物组合物的原料药的组成和重量份为:桑椹子2460重量份、西红花2140重量份、山大颜1930重量份、黄精890重量份、水绵4250重量份、半胱氨酸96重量份、二油酰基卵磷脂77重量份;
制备方法:
(1)按原料药配比取桑椹子、西红花、山大颜、黄精、水绵、半胱氨酸、二油酰基卵磷脂,混匀,用重量百分比浓度36%乙醇作为溶剂,在59℃温浸提取,提取次数为9次,每次提取时间为24小时,每次溶剂用量为原料药总重量的44倍,滤过,得药渣A和提取液A,提取液A回收乙醇,浓缩至相对密度1.14,滤过,药液通过LSA-40大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度54%乙醇溶液洗脱LSA-40大孔吸附树脂柱,收集重量百分比浓度54%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物A;
(2)取步骤(1)药渣A,用重量百分比浓度58%乙醇作为溶剂,加热回流提取4次,每次提取时间为5小时,每次溶剂用量为药渣A重量的15倍,滤过,得药渣B和提取液B,提取液B回收乙醇,浓缩至相对密度1.15,滤过,药液通过DM11大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度65%乙醇溶液洗脱DM11大孔吸附树脂柱,收集重量百分比浓度65%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物B;
(3)将提取物A和提取物B混匀,即得药物组合物。
实施例4:片剂的制备
取实施例1药物组合物305g,加入淀粉105g,混匀,制粒,干燥,加微晶纤维素33g,硬脂酸镁5g,混匀,压制成1000片, 即得药物组合物片剂。
实施例5:胶囊的制备
取实施例2药物组合物312g,加入淀粉80g,混匀,制粒,干燥,整粒,加入适量硬脂酸镁,混匀,装胶囊1000粒,即得药物组合物胶囊。
实施例6:滴丸的制备
称取聚乙二醇 6000 193g水浴(80℃)加热煮熔,加入实施例3药物组合物14g,充分搅拌均匀,以液体石蜡为冷却剂,置玻璃管(4*80cm)中,冷却温度为5℃,滴口内外径为7.0/2.0(mm/mm),滴口距液面为2.4cm,滴速以每分58滴为最佳条件,用棉布吸干滴丸表面的冷凝剂,即得药物组合物滴丸。
实施例7:治疗艾滋病痴呆综合征精神行为症状的药物组合物
治疗艾滋病痴呆综合征精神行为症状的药物组合物的原料药的组成和重量份为:
山大颜2150重量份、黄精1850重量份、水绵3150重量份、半胱氨酸25重量份、二油酰基卵磷脂50重量份。
实施例8:治疗艾滋病痴呆综合征精神行为症状的药物组合物
治疗艾滋病痴呆综合征精神行为症状的药物组合物的原料药的组成和重量份为:
山大颜2100重量份、黄精1900重量份、水绵3100重量份、半胱氨酸30重量份、二油酰基卵磷脂45重量份。
实施例9:治疗艾滋病痴呆综合征精神行为症状的药物组合物
治疗艾滋病痴呆综合征精神行为症状的药物组合物的原料药的组成和重量份为:
山大颜2200重量份、黄精1800重量份、水绵3200重量份、半胱氨酸20重量份、二油酰基卵磷脂55重量份。
实验例1:治疗艾滋病痴呆综合征精神行为症状的试验研究
1 对象和方法
选择2014 年12月至2015 年12月在济宁第一人民医院感染科治疗的门诊及住院ADC患者。诊断符合《国际疾病分类》第l0版,且伴有不同程度的行为紊乱、睡眠障碍等精神行为症状,ADC临床分为0.5~2 期之间;简易精神状态检查(MMSE )分在17—23分;年龄40.5~71岁,平均(48.25±2.15)岁;病程2—6年,平均(3.19±1.19 )年;文化程度:文盲10例,小学16例,初中15例,高中及以上10例; 既往有获得性免疫缺陷综合征(AIDS)病史,接受高效抗逆转录病毒治疗(HAR RT)> 1年,人组前2 周未使用任何抗精神病药;征得其监护人的知情同意。共入组51例,男35例,女l6例。
所有患者系统接受控制机会性感染的同时给予药物组合物(实施例1药物组合物批号20140425),每次2.0g,每日2次服用;疗程8周。分别在患者治疗前及治疗后2、4、8 周应用MMSE、日常生活能力评分(A D L)及阳性和阴性症状量表 (PANSS )评定总分,PA N SS减分率30%~70%为有效,>70%为显效,<30%为无效,以治疗中出现的症状量表(TESS)评定不良反应,并在治疗前后检查患者的血常规、尿常规、肝功能、肾功能、心电图和脑电图。采用SPSS13.0统计软件进行统计分析,统计方法采用t检验和X2 检验。
2 结果
51例患者中有2例因病情恶化死亡,3例患者因服用药物组合物(实施例1药物组合物批号20140425)后出现明显嗜睡而停止服用治疗。实际完成46例。治疗8周患者MMSE评分较治疗前明显提高,治疗前后比较差异有统计学意义[(20.16±1.26)与(25.35±0.86 ),(P<0.05)]。治疗8 周后与治疗前比较AD L评分显著下降[(44 .16±9.96)与(26.55±8.56),P<0.05]。治疗2 周患者PA NSS评分为(54.36±13.36),明显低于治疗前(91.16±7.56),P<0.05;经过4周和8周治疗,患者PANSS评分为(44.26±12.66)分和(36.876±9.46)分,均明显低于治疗前(P 均<0.01)。
患者不良反应总发生率为13.0%(6/46)。服用药物组合物(实施例1药物组合物批号20140425)后患者出现嗜睡、体质量增加较明显。
实验例1:典型病例
陆XX,男,50岁,艾滋病痴呆综合征精神行为症状患者,主要症状:记忆力减退,智力下降,生活能力也下降,还伴有幻觉、妄想以及冲动行为。2015年11月26日开始口服该药物组合物(实施例1药物组合物批号20140425),每次2.0g,每日2次服用,连续8周,患者症状全无,后又继续服用2周,彻底治愈。
Claims (8)
1.一种治疗艾滋病痴呆综合征精神行为症状的药物组合物,其特征在于制成该药物组合物的原料药的组成和重量份为:
桑椹子2360—2460重量份、西红花2140—2240重量份、山大颜1830—1930重量份、黄精890—990重量份、水绵4150—4250重量份、半胱氨酸96—106重量份、二油酰基卵磷脂67—77重量份。
2.根据权利要求1所述一种治疗艾滋病痴呆综合征精神行为症状的药物组合物,其特征在于制成该药物组合物的原料药的组成和重量份为:
桑椹子2410重量份、西红花2190重量份、山大颜1880重量份、黄精930重量份、水绵4200重量份、半胱氨酸101重量份、二油酰基卵磷脂72重量份。
3.根据权利要求1所述一种治疗艾滋病痴呆综合征精神行为症状的药物组合物,其特征在于药物组合物可以采用制剂学的常规方法制备成片剂或胶囊剂或滴丸。
4.根据权利要求1所述一种治疗艾滋病痴呆综合征精神行为症状的药物组合物,其特征在于药物组合物与化学药或中药组成的治疗艾滋病痴呆综合征精神行为症状药物。
5.一种治疗艾滋病痴呆综合征精神行为症状的药物组合物的制备方法,其特征在于按如下步骤制备:
原料药的组成和重量份为:桑椹子2360—2460重量份、西红花2140—2240重量份、山大颜1830—1930重量份、黄精890—990重量份、水绵4150—4250重量份、半胱氨酸96—106重量份、二油酰基卵磷脂67—77重量份;
制备方法:
(1)按原料药配比取桑椹子、西红花、山大颜、黄精、水绵、半胱氨酸、二油酰基卵磷脂,混匀,用重量百分比浓度36%乙醇作为溶剂,在59℃温浸提取,提取次数为9次,每次提取时间为24小时,每次溶剂用量为原料药总重量的44倍,滤过,得药渣A和提取液A,提取液A回收乙醇,浓缩至相对密度1.14,滤过,药液通过LSA-40大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度54%乙醇溶液洗脱LSA-40大孔吸附树脂柱,收集重量百分比浓度54%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物A;
(2)取步骤(1)药渣A,用重量百分比浓度58%乙醇作为溶剂,加热回流提取4次,每次提取时间为5小时,每次溶剂用量为药渣A重量的15倍,滤过,得药渣B和提取液B,提取液B回收乙醇,浓缩至相对密度1.15,滤过,药液通过DM11大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度65%乙醇溶液洗脱DM11大孔吸附树脂柱,收集重量百分比浓度65%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物B;
(3)将提取物A和提取物B混匀,即得药物组合物。
6.根据权利要求5所述一种治疗艾滋病痴呆综合征精神行为症状的药物组合物的制备方法,其特征在于按如下步骤制备:
原料药的组成和重量份为:桑椹子2410重量份、西红花2190重量份、山大颜1880重量份、黄精930重量份、水绵4200重量份、半胱氨酸101重量份、二油酰基卵磷脂72重量份;
制备方法:
(1)按原料药配比取桑椹子、西红花、山大颜、黄精、水绵、半胱氨酸、二油酰基卵磷脂,混匀,用重量百分比浓度36%乙醇作为溶剂,在59℃温浸提取,提取次数为9次,每次提取时间为24小时,每次溶剂用量为原料药总重量的44倍,滤过,得药渣A和提取液A,提取液A回收乙醇,浓缩至相对密度1.14,滤过,药液通过LSA-40大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度54%乙醇溶液洗脱LSA-40大孔吸附树脂柱,收集重量百分比浓度54%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物A;
(2)取步骤(1)药渣A,用重量百分比浓度58%乙醇作为溶剂,加热回流提取4次,每次提取时间为5小时,每次溶剂用量为药渣A重量的15倍,滤过,得药渣B和提取液B,提取液B回收乙醇,浓缩至相对密度1.15,滤过,药液通过DM11大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度65%乙醇溶液洗脱DM11大孔吸附树脂柱,收集重量百分比浓度65%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物B;
(3)将提取物A和提取物B混匀,即得药物组合物。
7.根据权利要求5所述一种治疗艾滋病痴呆综合征精神行为症状的药物组合物的制备方法,其特征在于药物组合物可以采用制剂学的常规方法制备成片剂或胶囊剂或滴丸。
8.根据权利要求5所述一种治疗艾滋病痴呆综合征精神行为症状的药物组合物的制备方法,其特征在于药物组合物与化学药或中药组成治疗艾滋病痴呆综合征精神行为症状药物。
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