CN105902553A - 复方非那雄胺片及其制备工艺 - Google Patents
复方非那雄胺片及其制备工艺 Download PDFInfo
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- CN105902553A CN105902553A CN201610360713.8A CN201610360713A CN105902553A CN 105902553 A CN105902553 A CN 105902553A CN 201610360713 A CN201610360713 A CN 201610360713A CN 105902553 A CN105902553 A CN 105902553A
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- A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
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Abstract
本发明涉及一种复方非那雄胺片,其由下述原料制备而得:非那雄胺2.5kg,淀粉9.2kg,预胶化淀粉9.2kg,乳糖13.5kg,微晶纤维素11.6kg,羧甲基淀粉钠2.5kg,2%羟丙甲纤维素浆25kg,硬脂酸镁0.15kg,取上述原料,按照常规方法造粒,制备片剂50万片。本发明产品对前列腺增生治疗效果明显、稳定,应用前景广阔。
Description
技术领域
本发明属于药物技术领域,具体的,涉及一种复方非那雄胺片及其制备工艺。
背景技术
前列腺增生症是严重危害人类健康的常见多发病,且随年龄递增;且中国患者接近一亿人,是严重危害人类身心健康和寿命的疾病。随着人类社会进步,人口老龄化日趋严重,BPH的发病率在逐年升高。据统计,60~69岁的老年人中重度BPH患病率可达50%~60%,而年龄范围在70~80岁的老年人患病率则高达80%以上。有关前列腺增生的发病机制研究颇多,但病因至今仍未能阐明,前列腺增生的主要病症有以下几个症状: 1、尿频,尿频为早期症状,先为夜尿次数增加,但每次尿量不多。下尿路梗阻时,50%~80%的患者有尿急或急迫性尿失禁。膀胱逼尿肌失代偿后,发生慢性尿潴留,膀胱的有效容量因而减少,排尿间隔时间更为缩短。若伴有膀胱结石或感染,则尿频愈加明显,且伴有尿痛。 2、排尿困难,腺体增大,机械性梗阻加重,发现排尿困难症状,下尿路梗阻的程度与腺体大小不成正比。由于尿道阻力增加,患者排尿起始延缓,排尿时间延长,射程不远,尿线细而无力。小便分叉,有排尿不尽感觉。如梗阻进一步加重,患者必须增加腹压以帮助排尿。呼吸使腹压增减,出现尿流中断及淋漓。 残余尿是膀胱逼尿肌失代偿的结果。当残余尿量很大,膀胱过度膨胀且压力很高,高于尿道阻力,尿便自行从尿道溢出,称充溢性尿失禁。夜间熟睡后,盆底肌肉松弛,尿液更易自行流出,出现夜间遗尿。有的患者平时残余尿不多,但在受凉、饮酒、憋尿,服用药物或有其他原因引起交感神经兴奋时,可突然发生急性尿潴留。患者尿潴留的症状可时好时坏。部分患者可以是急性尿潴留为首发症状。 3、血尿,前列腺黏膜上毛细血管充血及小血管扩张并受到增大腺体的牵拉或与膀胱摩擦,当膀胱收缩时,可以引起镜下或肉眼血尿。
非那雄胺是常规的用于治疗前列腺增生的西药制剂,非那雄胺为一种4-氮杂甾体化合物,它是睾酮代谢成为更强的二氢睾丸酮过程中的细胞内酶-II型5a-还原酶的特异性抑制剂。而良性前列腺增生或称作前列腺肥大取决于前列腺内睾酮向二氢睾丸酮的转化。本药能非常有效地减少血液和前列腺内的二氢睾丸酮。非那雄胺对雄激素受体没有亲和力。非那雄胺属于5α还原酶抑制剂,其是通过其激素作用机制,即抑制睾酮转化成双氢睾酮(DHT),使前列腺体积缩小而改善症状、增加尿流速率、预防良性前列腺增生(BPH)进展。
然而,临床研究表明,采用非那雄胺治疗的男性患者有≥1%的人出现下列与用药有关的不良反应:性欲减退(非那雄胺1.8%,安慰剂1.3%)及阳痿(非那雄胺1.3%,安慰剂0.7%)。此外,男性患者有0.8%出现射精量减少,安慰剂对照组0.4%。中止保法止治疗后这些不良反应消失,在另一项研究中检测了非那雄胺对射精量的影响,发现与安慰剂无差异。非那雄胺上市后报告的不良事件还包括乳房触痛或肿大、过敏反应(包括皮疹、瘙痒、荨麻疹和口唇肿胀)和睾丸疼痛。
西药治疗由于存在不良反应及药物耐受性等原因使其应用受到限制,且西医治疗前列腺增生虽然当时见效,但是停药后容易复发不得根治,而且前列腺增生患者一般需要长期服药,易产生一系列的毒副作用,使老年病人难以承受,且费用昂贵。手术治疗适用范围窄,风险高;非手术介入治疗设备限制,且费用较高。相比之下,中医学治疗前列腺增生具有自已独特的理论,积累了丰富的经验,前列腺增生症属于中医学的“癃闭”的范畴,其主要病机是肾和膀胱气化失司导致的排尿困难,其中以小便不利,点滴而短少,病势较缓者称为“癃”;以小便闭塞,点滴全无,病势较急者 称为“闭”。癃闭之名,首见于《内经》,该书对癃闭的病位、病机作了概要的论述,如《素问标本病传论篇》谓:“膀胱病,小便闭”;《灵枢本输》云:“三焦者,……实者闭癃,虚则遗溺,遗溺则补之,闭癃则泻之。”癃闭的病位在膀胱,但和肾、脾、肺三焦均有密切的关系,其治疗应根据“六腑以通为用”的原则,着眼于通。中医药以其可靠的疗效和低毒无毒的优越性,已引起了世人的瞩目,因此,中医药治疗前列腺增生具有广阔的前景。
现有技术中药处方缺乏辩证,治疗周期长,对症性不强,疗效不明显,甚至还会给患者带来副作用,增加患者痛苦,从天然药物中寻找有效、安全的药物,已成为普遍需要解决的问题。
发明内容
本发明参考祖国医学对前列腺增生发病机理的认识以及治疗的宝贵经验,参阅已有合理组方,辨证论治,按照中国药典及药理配伍,推陈致新有所增益,辨证论治一直是中医药治疗疾病的核心理论,如何针对主要病机用药同时兼顾次要病机,兼顾共性与个性的治疗,从而最大程度体现中医治疗疾病的内涵与外延,是中成药配伍的一个现实难题。按中医辨证理论,造成该病的主要病因病机是湿热毒邪逆行,以致留驻下焦,阻于经络。发明者通过对传统中药的研究,并结合辩证论证,多方收集众家之长,寻求最佳治疗方案,从祖国医学宝库中,筛选出温胃散水、开宣肺气,淡渗利水,引浊外出,驱风散寒的天然成分,按中医理论组方,提取精华,结合传统中医技术精心配制成本发明的复方非那雄胺片,相对于西药,对前列腺增生治疗效果明显、稳定,有益男性健康。
为实现本发明目的,本发明采用的技术方案如下:
一种复方非那雄胺片,其由下述原料制备而得:
非那雄胺1kg,中草药成分1.5kg淀粉9.2kg,预胶化淀粉9.2kg,乳糖13.5kg,微晶纤维素11.6kg,羧甲基淀粉钠2.5kg,2%(质量分数)羟丙甲纤维素浆25kg,硬脂酸镁0.15kg,取上述原料,按照常规方法造粒,制备片剂50万片。
所述中草药成分,由下述原料制备而得:
桂枝、知母、熟地、王不留行、女贞子、淫羊藿、生姜、金钱草、杏仁、花椒、莪术、菟丝子、蒲公英、乳香、沉香、车前子、连翘、黄柏、牛膝、五味子、荆芥、山药、鱼腥草、
皂角刺、葛根、茵陈、苍术、甘草、麦冬、陈皮。
优选地,所述中草药成分,由下述重量的原料制备而得:
桂枝40份、知母40份、熟地40份、王不留行35份、女贞子35份、
淫羊藿35份、生姜35份、金钱草35份、杏仁30份、花椒30份、
莪术30份、菟丝子30份、蒲公英28份、乳香28份、沉香28份、
车前子28份、连翘25份、黄柏25份、牛膝25份、五味子25份、
荆芥25份、山药20份、鱼腥草20份、皂角刺20份、葛根20份、
茵陈20份、苍术15份、甘草15份、麦冬10份、陈皮10份。
所述中草药成分的制备方法为:
1)称取各原料药,备用;
2)取生姜、山药、甘草用文火炒8分钟,粉碎过90目筛,制备成分A;
3)取桂枝、熟地、王不留行、淫羊藿、金钱草、花椒、蒲公英、沉香、车前子、五味子、荆芥、鱼腥草、茵陈、麦冬放入容器内,加入4倍量的蒸馏水,浸泡1小时后,煮沸2小时,提取煎煮液;再次加入3倍量蒸馏水,煮沸1小时,提取煎煮液;最后,加入2倍量蒸馏水,加热煮沸1小时,提取煎煮液;合并三次煎煮液,浓缩成密度为1.3g/ml的浸膏,60℃干燥后,粉碎制备成分B;
4)取剩余原料添加3倍重量70%(体积比)的乙醇,回流提取2次,每次1小时,提取液合并,浓缩至密度为1.3g/ml的浸膏,60℃干燥后,粉碎制备成分C;
5)均匀混合成分A、B、C即得。
每次1片(含非那雄胺2mg),每天1次,空腹服用或与食物同时服用均可。
本发明药物的组分降低了非那雄胺的成分配比,每片降低了60%的纯西药成分含量,也大大降低了由于非那雄胺导致的诸多副作用。中草药组分均采用天然的中药原料,其配制简便,药源广泛,成本低廉,其遵循中医的处方用药原则,诸药合用,相得益彰,君臣佐使各施其效,本发明的复方制剂能够促进前列腺体积缩小,有效缓解膀胱出口梗阻症状;而且对人体气血及五脏生理功能具有协调平衡作用,调理气机,达到治病求本的目的。适用于中老年男性前列腺增生、肥大导致的尿频、尿急、尿细线、排尿无力、尿滴沥、尿等待、尿失禁、尿潴留,需手术治疗者或者因身体其他原因不能手术者
具体实施方式
实施例1
一种复方非那雄胺片,其由下述原料制备而得:
非那雄胺1kg,中草药成分1.5kg淀粉9.2kg,预胶化淀粉9.2kg,乳糖13.5kg,微晶纤维素11.6kg,羧甲基淀粉钠2.5kg,2%羟丙甲纤维素浆25kg,硬脂酸镁0.15kg,取上述原料,按照常规方法造粒,制备片剂50万片。
所述中草药成分,由下述重量的原料制备而得:
桂枝40份、知母40份、熟地40份、王不留行35份、女贞子35份、
淫羊藿35份、生姜35份、金钱草35份、杏仁30份、花椒30份、
莪术30份、菟丝子30份、蒲公英28份、乳香28份、沉香28份、
车前子28份、连翘25份、黄柏25份、牛膝25份、五味子25份、
荆芥25份、山药20份、鱼腥草20份、皂角刺20份、葛根20份、
茵陈20份、苍术15份、甘草15份、麦冬10份、陈皮10份。
所述中草药成分的制备方法为:
1)称取各原料药,备用;
2)取生姜、山药、甘草用文火炒8分钟,粉碎过90目筛,制备成分A;
3)取桂枝、熟地、王不留行、淫羊藿、金钱草、花椒、蒲公英、沉香、车前子、五味子、荆芥、鱼腥草、茵陈、麦冬放入容器内,加入4倍量的蒸馏水,浸泡1小时后,煮沸2小时,提取煎煮液;再次加入3倍量蒸馏水,煮沸1小时,提取煎煮液;最后,加入2倍量蒸馏水,加热煮沸1小时,提取煎煮液;合并三次煎煮液,浓缩成密度为1.3g/ml的浸膏,60℃干燥后,粉碎制备成分B;
4)取剩余原料添加3倍重量70%(体积比)的乙醇,回流提取2次,每次1小时,提取液合并,浓缩至密度为1.3g/ml的浸膏,60℃干燥后,粉碎制备成分C;
5)均匀混合成分A、B、C即得。
每次1片(含非那雄胺2mg),每天1次,空腹服用或与食物同时服用均可。
实施例2
病理试验
丙酸睾丸酮诱发去势大鼠前列腺增生模型的影响
实验动物Wistar大鼠,雄性,体重120-150克,40只,乙醚麻醉下行去势术(无菌操作下摘除睾丸),术后3天选用状态良好的大鼠30只,随机分为模型组、对照组、实验组。另取大鼠10只,手术过程同前,但不摘除睾丸,作为对照组(假手术组)。
给药方法与剂量受试药物口服(灌胃)给药,对照组(假手术组)和模型组给予同体积蒸馏水,实验组给予实施例1制备的复方非那雄胺片,对照组给予市售非那雄胺片。每天给药一次,连续给药21天。在此期间,除假手术组外,其它3组动物隔天皮下注射丙酸睾丸酮注射液一次,剂量为25mg·kg-1体重,于末次给药后24小时,称量记录体重后处死大鼠,剪取大鼠前列腺,在腺体处剪去输精管、尿道和膀胱等,用微量电子天秤称取前列腺的湿重。将称取的湿重组织(mg)除以体重(以100克为单位),计算前列腺湿重系数。然后将其置于10%福尔马林液固定,常规脱水透明,石蜡切片,邢染色,于光学显微镜下观察组织形态变化。镜下选取5个前列腺管腔,在图像处理仪下分别测量管腔壁厚度(1am)及管腔直径(um)。
数据处理以组为单位,分别计算各组动物前列腺平均湿重系数,比较各组动物前列腺湿重系数。组间差异的显著性检验用t检验。结果如下表1:
表1
组别 | 例数 | 湿重系数mg/100g |
假手术组 | 10 | 13.31±7.33 |
模型组 | 10 | 160.31±6.47 |
对照组 | 10 | 140.11±10.36 |
实验组 | 10 | 131.35±9.64 |
表明本发明药物对丙酸睾丸酮诱发的前列腺增生模型较之对照组和模型组有明显的改善作用。
实施例3
收集78例前列腺增生症的门诊患者,年龄32-59岁,病程1-12月。随机分为:治疗组39例,对照组39例。两组年龄、病情等资料无显著性差异,具有可比性。
诊断依据
参照《中药病证诊断疗效标准》
开始尿频,尤其夜尿次数增多,渐有排尿困难,余溺不尽,严重时可有尿闭或小便失禁。
本病多见于老年男性。
直肠指诊:精室肥大,表面光滑而无结节,边缘清楚,中等硬度而富弹性,中央沟变浅或消失。
B超检查:前列腺大小测定较正常增大,膀胱残留尿大于60毫升。
试验方法
对照组给予市售非那雄胺片,每次1片(含非那雄胺2mg),每天1次,空腹服用或与食物同时服用均可。
实验组给予实施例1制备的复方非那雄胺片,每次1片(含非那雄胺5mg),每天1次,空腹服用或与食物同时服用均可。
疗效标准与治疗结果
疗效标准
参照国家中医药管理局颁布的行业标准《中医病证诊断疗效标准》,对于前列腺增生症疗效评定:
治愈:排尿通畅,前列腺检查明显缩小,无残余尿。
好转:排尿症状好转,残余尿减少。
未愈:症状和各项检查均无改善。
治疗统计结果见表2。
表2 疗效结果
组别 | 例数 | 治愈 | 好转 | 未愈 | 总有效率 |
治疗组 | 39 | 23 | 12 | 4 | 89.7% |
对照组 | 39 | 16 | 13 | 10 | 74.3% |
治疗组较对照组差异显著。
以上列举的仅是本发明的最佳具体实施例。显然,本发明不限于以上实施例,还可以有许多变形。本领域的普通技术人员能从本发明公开的内容直接导出或联想到的所有变形,均应认为是本发明的保护范围。
Claims (4)
1.一种复方非那雄胺片,其由下述原料制备而得:
非那雄胺1kg,中草药成分1.5kg,淀粉9.2kg,预胶化淀粉9.2kg,乳糖13.5kg,微晶纤维素11.6kg,羧甲基淀粉钠2.5kg,2%羟丙甲纤维素25kg,硬脂酸镁0.15kg,取上述原料,按照常规方法造粒,制备片剂50万片。
2.根据权利要求1所述的复方非那雄胺片,其特征在于,所述中草药成分由下述重量的原料药制备而得:
桂枝40份、知母40份、熟地40份、王不留行35份、女贞子35份、
淫羊藿35份、生姜35份、金钱草35份、杏仁30份、花椒30份、
莪术30份、菟丝子30份、蒲公英28份、乳香28份、沉香28份、
车前子28份、连翘25份、黄柏25份、牛膝25份、五味子25份、
荆芥25份、山药20份、鱼腥草20份、皂角刺20份、葛根20份、
茵陈20份、苍术15份、甘草15份、麦冬10份、陈皮10份。
3.根据权利要求1-2所述的复方非那雄胺片,其特征在于,所述中草药成分的制备方法为:
1)称取各原料药,备用;
2)取生姜、山药、甘草,混合,用文火炒8分钟,粉碎过90目筛,制备成分A;
3)取桂枝、熟地、王不留行、淫羊藿、金钱草、花椒、蒲公英、沉香、车前子、五味子、荆芥、鱼腥草、茵陈、麦冬,混合,放入容器内,加入4倍重量的蒸馏水,浸泡1小时后,煮沸2小时,提取煎煮液;再次加入3倍重量蒸馏水,煮沸1小时,提取煎煮液;最后,加入2倍重量的蒸馏水,加热煮沸1小时,提取煎煮液;合并三次煎煮液,浓缩成密度为1.3g/ml的浸膏,60℃干燥后,粉碎制备成分B;
4)取剩余原料药,混合,添加3倍重量70%(体积比)的乙醇,回流提取2次,每次1小时,提取液合并,浓缩至密度为1.3g/ml的浸膏,60℃干燥后,粉碎制备成分C;
5)均匀混合成分A、B、C,即得。
4.权利要求1-3所述复方非那雄胺片的药物应用。
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