CN114984115B - 一种消银颗粒中药组合物的制备方法 - Google Patents

一种消银颗粒中药组合物的制备方法 Download PDF

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CN114984115B
CN114984115B CN202210809501.9A CN202210809501A CN114984115B CN 114984115 B CN114984115 B CN 114984115B CN 202210809501 A CN202210809501 A CN 202210809501A CN 114984115 B CN114984115 B CN 114984115B
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王延岭
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Shaanxi Kanghui Pharmaceutical Co Ltd
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Abstract

本发明涉及一种消银颗粒中药组合物的制备方法,该消银颗粒中药组合物是由地黄、牡丹皮、赤芍、当归、苦参、金银花、玄参、牛蒡子、蝉蜕、白鲜皮、防风、大青叶、红花共十三味中药制备而成;该药具有清热凉血、养血润燥、祛风止痒的功效,用于银屑病的治疗;主要用于血热风燥型白疕和血虚风燥型白疕,症见皮疹为点滴状,基底鲜红色,表面覆有银白色鳞屑,或皮疹表面覆有较厚的银白色鳞屑,较干燥,基底淡红色瘙痒较甚者。其临床药效学试验效果显著,工艺先进,生物利用度高,且无任何毒副作用。

Description

一种消银颗粒中药组合物的制备方法
技术领域
本发明涉及一种消银颗粒中药组合物的制备方法,属于制药技术领域。
技术背景
银屑病是临床中比较常见和多发的一种疾病,常见皮疹为点滴状,基底鲜红色,表面覆有银白色鳞屑,或皮疹表面覆有较厚的银白色鳞屑;严重的影响了人们的日常生活;现有治疗此病的中成药很多,但大多治疗效果都不够理想。现有技术专利检索:1、中国专利公报2004年9月15日公开了名称为“治疗银屑病的颗粒及其制备工艺”公开号为CN1528416A的专利申请;2、2017年02月01日中国专利公报公开了名称为“无糖型消银颗粒及其质量检测方法”,公开号为CN106361884A的专利申请;3、2008年6月18日中国专利公报公开了名称为“治疗银屑病的中药及其制备方法”,公开号为CN 101199663A的专利申请;4、2002年9月11日中国专利公报公开了名称为“纳米消银制剂药物及其制备方法”,公开号为CN1368099A的专利申请;5、《中国药典2020版一部》2020年5月公开了消银胶囊和消银片的处方及制法。在实际应用过程中我们发现用以上这五种制备工艺制成的中成药的效果均不够理想;以上专利申请CN1528416A和CN106361884A是申请人申请的关于消银颗粒的相关专利,《中国药典2020版一部》2020年5月公开了消银胶囊和消银片的处方配比及制法与CN106361884A专利公开的消银颗粒的处方配比及制法完全相同,专利申请人在近几年的时间里,通过发掘祖国丰富的中医药资源,结合大量的临床药效学研究,应用现代制药技术对该产品“消银颗粒”的工艺进行二次开发,通过大量的实验摸索,意外的发现将原工艺中“金银花、红花粉碎成细粉;其余玄参、地黄、牡丹皮、赤芍、当归、苦参、牛蒡子、蝉蜕、白鲜皮、防风、大青叶共十一味70%乙醇提取”部分改为“金银花、牡丹皮、防风加水提取挥发油,其余地黄、赤芍、当归、苦参、玄参、牛蒡子、蝉蜕、白鲜皮、大青叶、红花共十味50%乙醇提取”后,用此工艺制成的消银颗粒,临床药效学试验效果显著提高,且无任何毒副作用。
发明内容
本发明的目的是提供一种工艺先进,疗效更为显著的一种消银颗粒中药组合物的制备方法。此制剂具有清热凉血、养血润燥、祛风止痒的功效,用于银屑病的治疗;主要用于血热风燥型白疕和血虚风燥型白疕,症见皮疹为点滴状,基底鲜红色,表面覆有银白色鳞屑,或皮疹表面覆有较厚的银白色鳞屑,较干燥,基底淡红色瘙痒较甚者。
现有技术:1、中国专利公报2004年9月15日公开了名称为“治疗银屑病的颗粒及其制备工艺”公开号为CN1528416A的专利申请;2、2017年02月01日中国专利公报公开了名称为“无糖型消银颗粒及其质量检测方法”,公开号为CN106361884A的专利申请;3、2008年6月18日中国专利公报公开了名称为“治疗银屑病的中药及其制备方法”,公开号为CN101199663A的专利申请;4、2002年9月11日中国专利公报公开了名称为“纳米消银制剂药物及其制备方法”,公开号为CN 1368099A的专利申请;5、《中国药典2020版一部》2020年5月公开了消银胶囊和消银片的处方及制法。在实际应用过程中我们发现用以上这五种制备工艺制成的中成药的效果均不够理想;
以上专利申请CN1528416A和CN106361884A是申请人申请的关于消银颗粒的相关专利,《中国药典2020版一部》2020年5月公开了消银胶囊和消银片的处方配比及制法与CN106361884A专利公开的消银颗粒的处方配比及制法完全相同,专利申请人在近几年的时间里,通过发掘祖国丰富的中医药资源,结合大量的临床药效学研究,应用现代制药技术对该产品“消银颗粒”的工艺进行二次开发,通过大量的实验摸索,意外的发现将原工艺中“金银花、红花粉碎成细粉;其余玄参、地黄、牡丹皮、赤芍、当归、苦参、牛蒡子、蝉蜕、白鲜皮、防风、大青叶共十一味70%乙醇提取”部分改为“金银花、牡丹皮、防风加水提取挥发油,其余地黄、赤芍、当归、苦参、玄参、牛蒡子、蝉蜕、白鲜皮、大青叶、红花共十味50%乙醇提取”后,用此工艺制成的消银颗粒,临床药效学试验效果显著提高,且无任何毒副作用。
本发明是这样构成的:由如下重量配比的13味中药材经加工制成的颗粒剂,本发明中药组合物,其配方组成如下:
Figure BDA0003740056770000021
制备方法为:以上十三味,金银花、牡丹皮、防风加水10倍量蒸馏提取挥发油4小时,收集挥发油备用,滤液备用;其余地黄、赤芍、当归、苦参、玄参、牛蒡子、蝉蜕、白鲜皮、大青叶、红花共十味酌予碎断,加8倍量50%的乙醇浸渍12小时,滤过,再加50%的乙醇适量,回流提取12小时,滤过,合并提取液,回收乙醇至无醇味,与挥发油提取所得滤液合并,浓缩成稠膏,低温干燥,粉碎成细粉,加入阿司帕坦和糊精辅料,混匀,制粒,干燥,整粒,喷入挥发油,制成1000g颗粒,装袋,即得颗粒剂。
本发明方案是经过发明人多次反复试验,不断改进调整总结出来的,与现有技术相比,本发明具有工艺先进,疗效更为显著,其临床药效学试验效果显著提高,生物利用度高,且无任何毒副作用。
本发明提供的是一种具有明确的配方和制备方法,有充足的动物实验以证明该药物具有清热凉血、养血润燥、祛风止痒的功效,用于银屑病的治疗;主要用于血热风燥型白疕和血虚风燥型白疕,症见皮疹为点滴状,基底鲜红色,表面覆有银白色鳞屑,或皮疹表面覆有较厚的银白色鳞屑,较干燥,基底淡红色瘙痒较甚者。其临床药效学试验效果显著,工艺先进,生物利用度高,且无任何毒副作用。
主要药效学试验
实验药物的制备:
1、试验用药物的制备:
本发明消银颗粒组:按照本发明实施例1的方法制得颗粒剂。
a组为:按照公开号为CN1528416A专利申请说明书实施例1的方法制得的颗粒剂;
b组为:按照公开号为CN106361884A专利申请说明书具体实施例1的方法制得的颗粒剂;
c组为:按照公开号为CN101199663A专利申请说明书具体实施例1方法制得的片剂;
d组为:按照本发明实施例1的方法,实施例1使用的50%乙醇改为80%乙醇,制成的颗粒剂,具体工艺如下:
组方配比:
Figure BDA0003740056770000031
制备方法为:以上十三味,金银花、牡丹皮、防风加水10倍量蒸馏提取挥发油4小时,收集挥发油备用,滤液备用;其余地黄、赤芍、当归、苦参、玄参、牛蒡子、蝉蜕、白鲜皮、大青叶、红花共十味酌予碎断,加8倍量80%的乙醇浸渍12小时,滤过,再加80%的乙醇适量,回流提取12小时,滤过,合并提取液,回收乙醇至无醇味,与挥发油提取所得滤液合并,浓缩成稠膏,低温干燥,粉碎成细粉,加入阿司帕坦和糊精辅料,混匀,制粒,干燥,整粒,喷入挥发油,制成1000g颗粒,装袋,即得颗粒剂。
e组为:按照本发明实施例1的方法,实施例1使用的50%乙醇改为60%乙醇,制成的颗粒剂,具体工艺如下:
组方配比:
Figure BDA0003740056770000032
Figure BDA0003740056770000041
制备方法为:以上十三味,金银花、牡丹皮、防风加水10倍量蒸馏提取挥发油4小时,收集挥发油备用,滤液备用;其余地黄、赤芍、当归、苦参、玄参、牛蒡子、蝉蜕、白鲜皮、大青叶、红花共十味酌予碎断,加8倍量60%的乙醇浸渍12小时,滤过,再加60%的乙醇适量,回流提取12小时,滤过,合并提取液,回收乙醇至无醇味,与挥发油提取所得滤液合并,浓缩成稠膏,低温干燥,粉碎成细粉,加入阿司帕坦和糊精辅料,混匀,制粒,干燥,整粒,喷入挥发油,制成1000g颗粒,装袋,即得颗粒剂。
实验目的:通过对本发明消银颗粒组和a组、b组、c组、d组、e组的抗炎、抑制细胞增殖、止痒、抗敏、机体免疫等药理实验研究,将本发明消银颗粒与a组、b组、c组、d组、e组进行对比,观察其药理作用的强弱。
试验方法:本发明消银颗粒组和a组、b组、c组、d组、e组对二甲苯所致小鼠耳廓肿胀的影响;对小鼠阴道上皮细胞有丝分裂的影响;对磷酸组胺引起豚鼠致痒反应的影响;对二硝基氯苯诱发小鼠迟发型皮肤过敏反应的影响;对小鼠网状内皮系统的影响。
一、对二甲苯所致小鼠耳廓肿胀的影响
实验材料
1、动物:昆明种小鼠,雌雄兼有,体重18~22g。
2、药物:本发明消银颗粒组;a组、b组、c组、d组、e组五个剂量组。药物在实验前用蒸馏水配置,灌胃给药。
实验方法
昆明种小鼠70只,雌雄各半,体重18~22g,随机分成7组,每组10只。对照组灌胃同体积的蒸馏水;本发明消银颗粒组和a组、b组、c组、d组、e组分别灌胃给药均为4.2g/kg。连续给药7d,每日1次,末次给药1h后,用100%二甲苯0.03ml/只涂于右耳内外两面,左耳不作任何处理,0.5h后将小鼠乙醚麻醉处死,减下双耳用9mm直径打孔器分别在小鼠的同一部位打下圆耳片,称重。计算出小鼠耳肿胀度(小鼠耳肿胀度=右耳片重量-左耳片重量)。实验结果:见表1
表1对小鼠耳廓二甲苯所致肿胀的影响
Figure BDA0003740056770000042
Figure BDA0003740056770000051
与对照组相比*P<0.05;**P<0.01;与a组、b组、c组、d组、e组比△P<0.05。
结果表明:本发明消银颗粒组和a组、b组、c组、d组、e组对二甲苯所致小鼠耳廓肿胀具有显著的抑制作用,a组、b组、c组、d组、e组与对照组相比有显著性差异(P<0.05);本发明消银颗粒组与对照组相比有极显著性差异(P<0.01);本发明消银颗粒组与a组、b组、c组、d组、e组相比较有显著性差异(P<0.05)。可见,本发明消银颗粒组比a组、b组、c组、d组、e组抗炎作用强。
二、对小鼠阴道上皮细胞有丝分裂的影响
实验材料
1、动物:昆明种雌性小鼠,体重18~22g。
2、药物:本发明消银颗粒组;a组、b组、c组、d组、e组五个剂量组。药物在实验前用蒸馏水配置,灌胃给药。
实验方法
昆明种雌性小鼠70只,体重18~22g,随机分成7组,每组10只。为避免细胞有丝分裂的日夜节律对数据的影响,每日早上8点统一灌胃给药,对照组灌胃同体积的蒸馏水;本发明消银颗粒组和a组、b组、c组、d组、e组分别灌胃给药均为4.2g/kg。连续给药7d,每日1次。自给药前3d开始腹腔注射已烯雌酚,每次0.2mg/只,每日1次,连续注射3d。末次灌胃给药1小时后,腹腔注射秋水仙碱3mg/kg,使细胞处于有丝分裂的中期以便于计数。于末次给药当天下午2:00处死小鼠,取阴道标本用10%的福尔马林液常规固定、包埋、HE染色。用光学显微镜观察细胞有丝分裂,计数300个基底细胞中的有丝分裂数,算出每100个基底细胞的有丝分裂数为有丝分裂指数。实验结果:见表2
表2对小鼠阴道上皮细胞有丝分裂的影响
Figure BDA0003740056770000052
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Figure BDA0003740056770000053
Figure BDA0003740056770000061
与对照组相比*P<0.05;**P<0.01;与a组、b组、c组、d组、e组比△P<0.05。
结果表明:本发明消银颗粒组和a组、b组、c组、d组、e组可明显抑制小鼠阴道上皮细胞有丝分裂的活性,具有明显的抗增殖作用,a组、b组、c组、d组、e组与对照组相比有显著性差异(P<0.05);本发明消银颗粒组与对照组相比有极显著性差异(P<0.01);本发明消银颗粒组与a组、b组、c组、d组、e组相比较有显著性差异(P<0.05)。可见,本发明消银颗粒组比a组、b组、c组、d组、e组抑制细胞增殖作用强。
三、对磷酸组胺引起豚鼠致痒反应的影响
实验材料
1、动物:豚鼠,雌雄兼有,体重220~250g。
2、药物:本发明消银颗粒组;a组、b组、c组、d组、e组五个剂量组。药物在实验前用蒸馏水配置,灌胃给药。
实验方法
健康豚鼠70只,雌雄各半,体重220~250g,随机分成7组,每组10只。对照组灌胃同体积的蒸馏水;本发明消银颗粒组和a组、b组、c组、d组、e组分别灌胃给药均为1.6g/kg。连续给药7d,每日1次。于给药第7天用剪刀剪去豚鼠股外侧毛,面积约1cm2,用剃须刀剃净绒毛,再用粗砂纸擦伤至渗血。末次给药后1h,开始在创面处滴0.01%磷酸组织胺0.05ml/只,此后每隔3min依0.02%、0.03%、0.04%……递增浓度,每次均为0.05ml/只。直至出现豚鼠回头舔擦伤处,以引起豚鼠出现回头舔右股外侧所给予的磷酸组胺总量为致痒阈,求各组平均值。实验结果:见表3
表3对磷酸组胺引起豚鼠致痒反应的影响
Figure BDA0003740056770000062
Figure BDA0003740056770000063
与对照组相比*P<0.05;**P<0.01;与a组、b组、c组、d组、e组比△P<0.05。
结果表明:本发明消银颗粒组和a组、b组、c组、d组、e组能明显提高磷酸组胺引起豚鼠瘙痒的致痒阈,a组、b组、c组、d组、e组与对照组相比有显著性差异(P<0.05);本发明消银颗粒组与对照组相比有极显著性差异(P<0.01);本发明消银颗粒组与a组、b组、c组、d组、e组相比较有显著性差异(P<0.05)。可见,本发明消银颗粒组比a组、b组、c组、d组、e组的止痒作用强。
四、对二硝基氯苯所致小鼠迟发型皮肤过敏反应的影响
实验材料
1、动物:昆明种小鼠,雌雄兼有,体重18~22g。
2、药物:本发明消银颗粒组;a组、b组、c组、d组、e组五个剂量组。药物在实验前用蒸馏水配置,灌胃给药。
实验方法
昆明种小鼠70只,雌雄各半,体重18~22g,随机分成7组,每组10只。各组小鼠颈部去毛,用50%的二硝基氯苯丙酮溶液2μl/只均匀涂抹致敏,致敏当日开始灌胃给药。对照组灌胃同体积的蒸馏水;本发明消银颗粒组和a组、b组、c组、d组、e组分别灌胃给药均为4.2g/kg。连续给药12d,每日1次。末次给药后,在同一只小鼠将2.5%的二硝基氯苯丙酮溶液20μl/只均匀涂抹于小鼠腹部皮肤进行攻击,攻击24h后,每鼠尾静脉注射1%伊文思蓝10ml/kg,30min后处死小鼠,取下腹部蓝染皮肤,剪碎,置试管中,用1:1丙酮生理盐水混合液5ml浸泡24h,离心取上清液,用721型分光光度计(610nm)测定吸光度。
实验结果:见表4
表4对小鼠迟发型皮肤过敏反应的影响
Figure BDA0003740056770000071
Figure BDA0003740056770000072
与对照组相比*P<0.05;**P<0.01;与a组、b组、c组、d组、e组比△P<0.05。
结果表明:本发明消银颗粒组和a组、b组、c组、d组、e组显著增强二硝基氯苯所致小鼠迟发型过敏反应,a组、b组、c组、d组、e组与对照组相比有显著性差异(P<0.05);本发明消银颗粒组与对照组相比有极显著性差异(P<0.01);本发明消银颗粒组与a组、b
组、c组、d组、e组相比较有显著性差异(P<0.05)。可见,本发明消银颗粒组比a组、b组、c组、d组、e组抗皮肤迟发型过敏反应作用强。
五、对小鼠网状内皮系统的影响
实验材料
1、动物:昆明种雄小鼠,体重18~22g。
2、药物:本发明消银颗粒组;a组、b组、c组、d组、e组五个剂量组。药物在实验前用蒸馏水配置,灌胃给药。
实验方法
昆明种雄小鼠70只,体重18~22g,随机分成7组,每组10只。对照组灌胃同体积的蒸馏水;本发明消银颗粒组和a组、b组、c组、d组、e组分别灌胃给药均为4.2g/kg。连续给药7d,每日1次,末次给药后24h,与小鼠尾静脉注入稀释的印度墨汁0.1ml/10g,注入墨汁后30s和6min用特制取血吸管从小鼠眼眶后静脉丛取血0.025ml,立刻吹入0.1%碳酸钠液2ml中,吸管于该液中吸入、吹出数次,以充分洗出吸管壁附着之血液,取血完毕,以0.025ml正常小鼠血溶于2ml0.1%碳酸钠液校零,于分光光度计上波长675nm处测定吸光度,计算吞噬指数。实验结果:见表5
表5对小鼠炭粒的吞噬廓清能力的影响
Figure BDA0003740056770000081
Figure BDA0003740056770000082
与对照组相比*P<0.05;**P<0.01;与a组、b组、c组、d组、e组比△P<0.05。
结果表明:本发明消银颗粒组和a组、b组、c组、d组、e组可显著增强小鼠网状内皮系统吞噬功能,a组、b组、c组、d组、e组与对照组相比有显著性差异(P<0.05);本发明消银颗粒组与对照组相比有极显著性差异(P<0.01);本发明消银颗粒组与a组、b组、c组、d组、e组相比较有显著性差异(P<0.05)。可见,本发明消银颗粒组比a组、b组、c组、d组、e组提高机体免疫作用强。
实验结果:本发明消银颗粒组和a组、b组、c组、d组、e组明显抑制二甲苯所致小鼠耳廓肿胀;可明显抑制小鼠阴道上皮细胞有丝分裂的活性,具有抗增殖作用;能明显提高磷酸组胺引起豚鼠瘙痒的致痒阈;可明显抑制二硝基氯苯诱发小鼠迟发型皮肤过敏反应;能显著增强小鼠网状内皮系统吞噬功能,提高机体免疫力。
结论:本发明消银颗粒组比a组、b组、c组、d组、e组抗炎、抑制细胞增殖、止痒、抗过敏、提高机体免疫力等药理作用强,因此,本发明消银颗粒组比a组、b组、c组、d组、e组用于清热凉血,养血润燥,祛风止痒等临床疗效好。
具体实施方式:
实施例1:本发明颗粒剂的制备:
组方配比:
Figure BDA0003740056770000091
制备方法为:以上十三味,金银花、牡丹皮、防风加水10倍量蒸馏提取挥发油4小时,收集挥发油备用,滤液备用;其余地黄、赤芍、当归、苦参、玄参、牛蒡子、蝉蜕、白鲜皮、大青叶、红花共十味酌予碎断,加8倍量50%的乙醇浸渍12小时,滤过,再加50%的乙醇适量,回流提取12小时,滤过,合并提取液,回收乙醇至无醇味,与挥发油提取所得滤液合并,浓缩成稠膏,低温干燥,粉碎成细粉,加入阿司帕坦和糊精辅料,混匀,制粒,干燥,整粒,喷入挥发油,制成1000g颗粒,装袋,即得颗粒剂。

Claims (1)

1.一种消银颗粒中药组合物的制备方法,其特征在于所述中药组合物的配方组成为:
Figure FDA0003740056760000011
制备方法为:以上十三味,金银花、牡丹皮、防风加水10倍量蒸馏提取挥发油4小时,收集挥发油备用,滤液备用;其余地黄、赤芍、当归、苦参、玄参、牛蒡子、蝉蜕、白鲜皮、大青叶、红花共十味酌予碎断,加8倍量50%的乙醇浸渍12小时,滤过,再加50%的乙醇适量,回流提取12小时,滤过,合并提取液,回收乙醇至无醇味,与挥发油提取所得滤液合并,浓缩成稠膏,低温干燥,粉碎成细粉,加入阿司帕坦和糊精辅料,混匀,制粒,干燥,整粒,喷入挥发油,制成1000g颗粒,装袋,即得颗粒剂。
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CN1368099A (zh) * 2001-01-31 2002-09-11 杨孟君 纳米消银制剂药物及其制备方法
CN1528416A (zh) * 2003-10-17 2004-09-15 陕西康惠制药有限公司 治疗银屑病的颗粒及其制备工艺
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