CN115381912A - 一种降低癌性疼痛的外用中药复方制剂及其制备方法 - Google Patents
一种降低癌性疼痛的外用中药复方制剂及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种降低癌性疼痛的外用中药复方制剂及其制备方法,有效成分包括大黄、紫花地丁、川芎、全蝎、蟾酥、蚤休、山慈菇、姜黄、人工麝香、冰片、红花、桃仁、当归、龙血竭、莪术、蜈蚣、桂枝、制乳香、没药、细辛、薄荷脑。本发明外用中药复方制剂镇痛疗效显著,作用持久,能明显减轻患者痛苦,提高生存质量,且使用安全,无毒副作用,是治疗癌性疼痛的理想外用中成药,其生产工艺简单,生产周期短,保存时间长。
Description
技术领域
本发明属于中医药及制备技术领域,涉及一种降低癌性疼痛的外用中药复方制剂及其制备方法。
背景技术
癌性疼痛一般是指由肿瘤直接引起的疼痛,肿瘤侵犯或压迫神经根、神经干、神经丛或神经;侵犯脑和脊髓;肿瘤侵犯骨膜或骨骼;侵犯实质性脏器及空腔性脏器;侵犯或堵塞脉管系统;肿瘤引起局部坏死,溃疡,炎症等;在上述情况下均可导致严重的疼痛。在肿瘤治疗过程中所引起的疼痛,也被认为是癌性疼痛。
治疗癌性疼痛,运用WHO倡导的三段药物止痛方法,即第一阶段非激素类镇痛药,第二阶段可待因弱阿片类镇痛药,第三阶段吗啡等强阿片类镇痛药,虽然取得一定疗效,但由于肿瘤患者长期用药的特殊性,用药过久必然导致患者不能耐受。限制晚期肿瘤患者使用阿片类药物,而且药物耐受和成瘾后所造成的用药过量,使毒性蓄积,也会严重损害循环、呼吸及神经系统,以及肝、肾、骨髓、内分泌等功能,从而降低肿瘤患者生存质量,缩短其生存时间,如何有效地控制癌性疼痛是目前亟待解决的全球性研究课题,WHO已将控制癌痛列为肿瘤防治的四大重点之一。
癌性疼痛的治疗,西医采用的方法虽然能获得一定的效果,但出现的副作用较多,中医药对降低癌性的疼痛有一定的优势,中医外治法是其方法之一,它是在中医基础理论指导下,将中药或其他器械作用于皮肤、孔窍、经络、俞穴等部位,发挥疏通经络、调节气血、解毒化瘀、扶正祛邪等作用的治疗方法。外治法的渊源虽早,其理论基础在宋元时期才开始探讨。中医外治法形成于原始劳作时期,发展于汉朝,成熟于宋元时期,自形成到发展,由发展到成熟,历经2000多年,逐渐形成具有完善理论基础、丰富药物剂型的外治法体系。中医外治法历史悠久,《理瀹骈文》记载:“外治之理即内治之理,外治之药亦即内治之药,所异者法耳,医理药性无二。”现代专家提出晚期癌痛患者正气已虚,脾胃虚弱,内服药物可能不易吸收,外治法作用于皮肤、经络、腧穴,使药物直达局部病所,同样具有发挥药效、缓解病痛的作用。
中医外治法作为特色辅助镇痛疗法之一,历史悠久,疗效确切,简单易行,临床应用广泛,与常规“三阶梯”止痛疗法合用可有效增强治疗效果,并减少止痛药物的药量,降低药物的不良反应率。但近年来中医外治法还发现了一些不足之处。首先,癌症种类众多,现有专病专治的文献较少,单一的止痛疗法对不同的癌症类型表现出的疗效不一,应增加相关研究,尽快建立癌痛缓解专病专治的体系,针对不同类型的癌痛采用效果更好的外治方法,以提高临床疗效;其次,现有国内研究文献中,大多是临床用药疗效研究,对作用机制研究还相对较少,针灸对缓解癌痛的分子靶点研究尚不明确,还需要进一步研究,同时还应对缓解癌痛中药的有效性及成分进行更深入的研究,还缺乏此类项目的基础实验研究。现大多是临床经验用法,缺乏科学研究的基础。第三,近年来的研究大多是在“三阶梯”止痛疗法的基础上联合中医外治法,单用中医外治法治疗癌痛的文献很少。今后的研究应当考虑单用中医外治法的疗效,避免不适当的滥用。最后,国内研究大多是单中心、小样本的重复观察,缺乏多中心、大样本、盲法的研究,对外治方案的优化凝练不够。今后应当对外治方案不断优化,开展多中心、大样本的观察,建立疗效可靠、方案优化的中医外治癌痛新体系。
发明内容
为实现上述目的,本发明提供一种降低癌性疼痛的外用中药复方制剂,解决了现有药剂作用时间短,保存时间段,副作用较多的问题。
本发明还提供一种降低癌性疼痛的外用中药复方制剂的制备方法,解决了现有生产工艺复杂,生产周期长,有毒副作用的问题。
本发明所采用的一种技术方案是:一种降低癌性疼痛的外用中药复方制剂,由以下重量份数的原料有效成分组成:大黄2.744~3.087份,紫花地丁1.648~1.854份,川芎2.744~3.087份,全蝎1.648~1.854份,蟾酥0.164~0.1845份,蚤休3.292~3.7035份,山慈菇3.292~3.7035份,姜黄2.728~3.069份,人工麝香0.056~0.063份,冰片0.548~0.6165份,红花2.196~2.4705份,桃仁2.744~3.087份,当归2.744~3.087份,龙血竭1.648~1.854份,莪术2.744~3.087份,蜈蚣1.648~1.854份,桂枝3.292~3.7035份,制乳香1.648~1.854份,没药1.648~1.854份,细辛0.824~0.927份,薄荷脑0.1份组成。
本发明所采用的的另一技术方案是:一种降低癌性疼痛的外用中药复方制剂的制备方法,包括以下步骤:
S1,按照以下重量份数分别称取药材:大黄2.744~3.087份,紫花地丁1.648~1.854份,川芎2.744~3.087份,全蝎1.648~1.854份,蟾酥0.164~0.1845份,蚤休3.292~3.7035份,山慈菇3.292~3.7035份,姜黄2.728~3.069份,人工麝香0.056~0.063份,冰片0.548~0.6165份,红花2.196~2.4705份,桃仁2.744~3.087份,当归2.744~3.087份,龙血竭1.648~1.854份,莪术2.744~3.087份,蜈蚣1.648~1.854份,桂枝3.292~3.7035份,制乳香1.648~1.854份,没药1.648~1.854份,细辛0.824~0.927份,薄荷脑0.1份;热熔压敏胶作为基质,其重量份是蟾酥、大黄、紫花地丁、川芎、全蝎、蚤休、山慈菇、姜黄、红花、桃仁、当归、龙血竭、莪术、蜈蚣、桂枝、制乳香、没药、细辛十八味药材重量的1-1.5倍份;
S2,将称取的冰片、人工麝香两味药材取出备用;将蟾酥粗碎或剪碎后,与大黄、紫花地丁、川芎、全蝎、蚤休、山慈菇、姜黄、红花、桃仁、当归、龙血竭、莪术、蜈蚣、桂枝、制乳香、没药、细辛十七味药材60℃干燥至含水量8%以下,混合粉碎成细粉;
S3,将热熔压敏胶在135℃-145℃温度下完全融化,控制温度为120℃-130℃,加入S2所得细粉进行搅拌,搅拌均匀;
S4,膏体冷却至80℃-90℃,将冰片、人工麝香、薄荷脑共研成粉状加入至膏体进行搅拌,搅拌均匀即可得到外用药膏;
S5,保持温度80℃-85℃,将药膏摊涂于双向拉伸聚丙烯珠光薄膜上,涂布厚度控制在0.75mm-1.25mm,覆盖医用离型纸,卷成大药卷,并冷却至室温;
S6,将大药卷切制成大小合适的小药卷;
S7,将切好的药卷置贴合机上,贴合于带粘性的卫生用水刺法非织造布上,覆盖一层医用离型纸,切制成合适大小,包装。
进一步地,S3中搅拌时间为1.5h-2h。
进一步地,S4中搅拌时间为0.5h。
本发明的有益效果:
1.本发明的外用中药复方制剂是通过局部麻醉,改善肿瘤周围组织血液循环及直接抗肿瘤作用而发挥缓解疼痛的作用。
2.适用于癌性疼痛,肝癌、肺癌尤佳,镇痛疗效显著,作用持久,能明显减轻患者痛苦,提高生存质量,且使用安全,无毒副作用,是治疗癌性疼痛的理想外用中成药。
3.生产工艺相对简单,生产周期短,皮肤过敏概率小,使用时不受温度影响,保存时间长。
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。
本发明提供一种降低癌性疼痛的外用中药复方制剂,由以下重量份数的原料有效成分组成:大黄2.744~3.087份,紫花地丁1.648~1.854份,川芎2.744~3.087份,全蝎1.648~1.854份,蟾酥0.164~0.1845份,蚤休3.292~3.7035份,山慈菇3.292~3.7035份,姜黄2.728~3.069份,人工麝香0.056~0.063份,冰片0.548~0.6165份,红花2.196~2.4705份,桃仁2.744~3.087份,当归2.744~3.087份,龙血竭1.648~1.854份,莪术2.744~3.087份,蜈蚣1.648~1.854份,桂枝3.292~3.7035份,制乳香1.648~1.854份,没药1.648~1.854份,细辛0.824~0.927份,薄荷脑0.1份组成;热熔压敏胶作为基质,其重量份是蟾酥、大黄、紫花地丁、川芎、全蝎、蚤休、山慈菇、姜黄、红花、桃仁、当归、龙血竭、莪术、蜈蚣、桂枝、制乳香、没药、细辛十八味药材重量的1-1.5倍份。
大黄:性味苦,寒,归脾、胃、大肠、肝、心包经。具有泻下攻积、清热泻火、凉血解毒、逐瘀通经、利湿退黄的功效。《药品化义》:“大黄气味重浊,直降下行,走而不守,有斩关夺门之力,故号将军”。“治实热便秘”。《金匮要略》:“清热泻火,凉血止血。治血热妄行之吐血、衄血、咯血”。《和剂局方》:“治目赤肿痛、咽喉肿痛、牙龈肿痛等证”。《妇人良方》:“外用泻火解毒,凉血消肿。治热毒痈肿疔疖”。《医学发明》:“治跌打损伤,瘀血肿痛”。《保命集》:“泻下通便,导湿热外出。治肠道湿热积滞之痢疾”。
紫花地丁:性味苦、辛,寒,归心、肝经。具有清热解毒、凉血消肿的功效。《医宗金鉴》:“治乳痈,常与蒲公英同用,煎汤内服,并以渣外敷,或熬膏摊贴患处;治肠痈,常与大黄、大血藤、白花蛇舌草等同用”。
川芎:性味辛,温,归肝、胆、心包经。具有活血行气、祛风止痛的功效。《本草纲目》:“本品辛香形散,温通血脉,既能活血祛瘀,又能行气通滞,为“血中气药”,功善止痛,为治气滞血瘀诸证之要药。“下调经水,中开郁结”,善通达气血,为妇科活血调经要药。能“上行头目”,既能活血行气止痛,又长于祛风止痛,为治头痛之要药。”《医学心悟》:“本品辛散温通,能“旁通络脉”,具有祛风通络止痛之功,治风湿痹阻、肢节疼痛”。《金匮要略》:“治寒凝血瘀之经行腹痛,闭经”。《傅青主女科》:“治产后瘀阻腹痛,恶露不行”。
全蝎:性味辛,平,有毒,归肝经。具有息风镇痉、通络止痛、攻毒散结的功效。《经验方》:“治惊风、痉挛抽搐、瘰疬”。广州中医学院《方剂学》:“治破伤风痉挛抽搐、角弓反张”。《杨氏家藏方》:“风中经络、口眼斜”。
蟾酥:性味辛,温有毒,归心经。具有解毒、止痛、开窍醒神的功效。《外科正宗》:
“治痈疽恶疮,与雄黄、朱砂等配伍,用葱白汤送服取汗”。《喉科心法》:“治咽喉肿痛及痈疖”。《本草正》:“治风虫牙痛,单用本品研细少许点患处”。《医宗金鉴》:“传统常用本品与生川乌、生南星、生半夏为末,烧酒调敷患处,作麻药使用”。《集验简易良方》:“治伤于暑湿秽浊或饮食不洁而致痧胀腹痛,吐泻不止,甚至昏厥,用时研末吹入鼻中取嚏”。
蚤休:性味苦,微寒,有小毒,归肝经。具有清热解毒、消肿止痛、凉肝定惊的功效。《外科全生集》:“治痈肿疔毒,可单用为末,醋调外敷”。
山慈菇:性味甘、微辛,凉,归肝、脾经。具有清热解毒、化痰散结的功效。《百一选方》:“治痈疽发背、疔疮肿毒、瘰疬痰核、蛇虫咬伤”。
姜黄:性味辛、苦,温,归肝、脾经。具有破血行气、通络止痛的功效。《圣济总录》:“治气滞血瘀诸痛证”。《重订严氏济生方》:“治肝胃寒凝气滞治胸胁疼痛”。《妇人良方》:“治气滞血瘀治痛经经闭,产后腹痛”。《伤科方书》:“治跌打损伤,瘀肿疼痛”。
人工麝香:性味辛,温,归心、脾经。具有开窍醒神、活血通经、消肿止痛的功效。
冰片:性味辛、苦,微寒,归心、脾、肺经。具有开窍醒神、清热止痛的功效。《温病条辨》:“治热闭神昏”。《和剂局方》:“治寒闭神昏”。《中华人民共和国药典.一部》:“用治冠心病心绞痛”。《全国中成药处方集》:“治目赤肿痛”。《外科正宗》:“治咽喉肿痛、口舌生疮、牙龈肿痛”。《濒湖集简方》:“治风热喉痹”。《疡医大全》:“治疮疡溃后不敛”。《医林纂要》言:“冰片……,性走而不守,亦能生肌止痛。
红花:性味辛,温,归心、肝经。具有活血通经、散瘀止痛的功效。《金匮要略》:“治妇人腹中血气刺痛”。《医宗金鉴》:“治经闭痛经”。《报名集》:“治产后瘀滞腹痛”。《良方集腋》:“治跌打损伤、瘀滞肿痛”。
桃仁:性味苦、甘,平,归心、肝、大肠经。具有活血祛瘀、润肠通便、止咳平喘的功效。《医宗金鉴》:“治瘀血经闭、痛经”。《傅青主女科》:“治产后瘀滞腹痛”。《金匮要略》:“治瘀血蓄积之癥瘕痞块”。《伤寒论》:“治下焦蓄血证”。《医学发明》:“治跌打损伤,瘀肿疼痛”。《圣济总录》:“治咳嗽气喘”。
当归:性味甘、辛,温,归肝、心、脾经。具有补血活血、调经止痛、润肠通便的功效。《和剂局方》:“治血虚萎黄、心悸失眠、妇女月经不调、经闭、痛经、痈疽溃后不散”。《验方新编》:“治脱疽溃烂,阴血伤败”。
龙血竭:性味甘、咸,平,归心、肝经。具有活血定痛、化瘀止血、生肌敛疮的功效。《良方集腋》:“味咸入血分,主归心肝经,能活血散瘀,消肿止痛,为伤科及其他瘀滞痛证要药。治跌打损伤,筋骨疼痛。本品既能散瘀,又能止血,有止血不留瘀的特点,适用于瘀血阻滞,血不归经的出血,尤宜外伤出血。”
莪术:性味辛、苦,温,归肝、脾经。具有破血行气、消积止痛的攻效。《寿世保元》:“治经闭腹痛,腹中痞块”。《证治准绳》:“治食积气滞,脘腹胀痛”。
蜈蚣:性味辛,温,有毒,归肝经。具有息风镇痉、通络止痛、攻毒散结的功效。《经验方》:“治痉挛抽搐”。《证治准绳》:“治小儿撮口,手足抽搐”。《医宗金鉴》:“治破伤风、角弓反张”。《拔萃方》:“本品有毒,能以毒攻毒,味辛又能散结,同雄黄、猪胆汁配伍制膏,外敷恶疮肿毒”。
桂枝:性味辛、甘,温,归心、肺、膀胱经。具有发汗解肌、温通经脉、助阳化气、平冲降逆的功效。《伤寒论》:“治风寒感冒、风寒湿痹、水肿心悸、奔豚”。《金匮要略》:“治脘腹冷痛、血寒经闭、痰饮病”。
制乳香:性味辛、苦,温,归心、肝、脾经。具有活血定痛、消肿生肌的功效。《良方集腋》:“治跌打损伤”。《校注妇人良方》:“治疮疡肿毒初起,局部皮肤红肿热痛”。《外科全生集》:“治痈疽、瘰疬、痰核,肿块坚硬不消”。《疮疡经验全书》:“治疮疡溃破,久不收口”。《珍珠囊》谓其能“定诸经之痛”。《医学心悟》:“治胃脘疼痛,风寒湿痹,肢体麻木疼痛”。《医学衷中参西录》:“治痛经经闭,产后瘀阻腹痛”。
没药:性味辛、苦,平,归心、肝、脾经。具有散瘀定痛,消肿生肌的功效。
细辛:性味辛,温,归心、肺、肾经。具有解表散寒、祛风止痛、通窍、温肺化饮的功效。《此事难知》:“辛温发散,芳香透达,入肺经长于解表散寒,祛风止痛,宜于外感风寒,头身疼痛”。《伤寒论》:“细辛既入肺经散在表之风寒,又入肾经而除在里之寒邪,可治阳虚外感,恶寒发热、无汗、脉反沉者”。《证因脉治》:“治少阴头痛,足寒气逆,脉象沉细者”。《千金要方》:“细辛既散少阴肾经在里之寒邪以通阳散结,又搜筋骨间的风湿而浊痹止痛,治风寒湿痹,腰膝冷痛”。《金匮要略》:“治纯系寒痰停饮射肺,咳嗽胸满,气逆喘急”。《丹溪心法附余》:“治中恶或痰厥所致神昏窍闭证,常与皂荚共研末为散”。
本发明降低癌性疼痛的外用中药复方制剂以龙血竭为君药,活血止痛,散瘀生新;全蝎、蜈蚣通络止痛、攻毒散结,蟾酥、人工麝香活血消肿、解毒止痛,桃仁、红花、当归、川芎活血通经、散瘀止痛,莪术、姜黄破血、行气、止痛,制乳香行气通络、活血止痛,没药散瘀止痛,诸药共为臣药;佐以大黄、紫花地丁、蚤休、山慈菇清热解毒、攻毒散结;加用冰片、薄荷脑走窜,增强皮肤渗透效果以利透皮吸收,也是止痛良药,可清热止痛,消肿定痛,并中和诸多温燥药物,以达更好的治疗功用,又可助其他药物吸收扩散;辅料部分采用热熔压敏胶为基质,薄荷脑为透皮吸收促进剂。上述组方使本方寒热并用,通络止痛,更具解毒散结功效,以桂枝、细辛透皮药物为引药使直达病痛之所,共奏解毒散结,化瘀止痛之功效。
本发明的中药组方中多味药物具有明显的镇痛效果,其中制乳香、没药主要通过含有的挥发油达到止痛的作用;冰片在外用药中的作用主要是作为透皮剂促进药物吸收,同时具有一定的抗炎镇痛作用;细辛中含有的挥发油不仅有透皮剂效果,还可作用于中枢神经系统而止痛;蟾酥具有良好的止痛作用,历代医家将其作为麻醉药物之一,内服或外用于手术前局部麻醉,蟾酥能直接抑制神经纤维动作电位的形成、传导,产生神经阻滞麻醉作用。
本发明提供一种降低癌性疼痛的外用中药复方制剂的制备方法,包括以下步骤:
S1,按照以下重量份数分别称取药材:大黄2.744~3.087份,紫花地丁1.648~1.854份,川芎2.744~3.087份,全蝎1.648~1.854份,蟾酥0.164~0.1845份,蚤休3.292~3.7035份,山慈菇3.292~3.7035份,姜黄2.728~3.069份,人工麝香0.056~0.063份,冰片0.548~0.6165份,红花2.196~2.4705份,桃仁2.744~3.087份,当归2.744~3.087份,龙血竭1.648~1.854份,莪术2.744~3.087份,蜈蚣1.648~1.854份,桂枝3.292~3.7035份,制乳香1.648~1.854份,没药1.648~1.854份,细辛0.824~0.927份,薄荷脑0.1份;热熔压敏胶作为基质,其重量份是蟾酥、大黄、紫花地丁、川芎、全蝎、蚤休、山慈菇、姜黄、红花、桃仁、当归、龙血竭、莪术、蜈蚣、桂枝、制乳香、没药、细辛十八味药材重量的1-1.5倍份;
S2,将称取的冰片、人工麝香两味药材取出备用;将蟾酥粗碎或剪碎后,与大黄、紫花地丁、川芎、全蝎、蚤休、山慈菇、姜黄、红花、桃仁、当归、龙血竭、莪术、蜈蚣、桂枝、制乳香、没药、细辛十七味药材60℃干燥至含水量8%以下,混合粉碎成细粉。
本发明的外用中药复方制剂药味较少,若采用单独粉碎,其耗时长,不利于生产,浪费能源;故本发明采用混合粉碎的方式以省时节能,提高生产效率。
按照以下重量称取药材,分别取两组;称取大黄10g、紫花地丁6g、川芎10g、全蝎6g、蟾酥0.6g、蚤休12g、山慈菇12g、姜黄10g、红花8g、桃仁10g、当归10g、龙血竭6g、莪术10g、蜈蚣6g、桂枝12g、制乳香6g、没药6g、细辛3g,共143.6g。对照组将上述十八味药材60℃干燥,控制水分在8%以下,称重,粉碎成细粉,称重,计算出粉率,结果见表1;实验组将蟾酥粗碎或剪碎后,与剩余十七味药材在60℃干燥,控制水分于8%以下,称重,粉碎成细粉,称重,计算出粉率,结果见表2。
表1对照组出粉率实验结果
编号 | 1 | 2 | 3 |
饮片(g) | 143.62 | 143.73 | 149.66 |
细粉(g) | 122.81 | 122.34 | 128.18 |
出粉率(%) | 85.51 | 85.12 | 85.65 |
表2实验组出粉率实验结果
编号 | 1 | 2 | 3 |
饮片(g) | 143.63 | 143.67 | 143.72 |
细粉(g) | 134.22 | 134.32 | 137.94 |
出粉率(%) | 93.45 | 93.49 | 93.38 |
结果表明,饮片60℃干燥至其含水量小于8%时,样品的出粉率在85%,因为蟾酥是多张压制,导致干燥时,并未干燥完全;将蟾酥剪碎,与其他药材60℃干燥至其含水量小于8%时,样品的出粉率均在90%以上。
S3,将热熔压敏胶在135℃-145℃温度下完全融化,控制温度为120℃-130℃,加入S2所得细粉搅拌1.5h-2h,搅拌均匀;
本发明的外用中药复方制剂是全生药粉直接用药。以橡胶为基质的贴膏生产过程中使用大量汽油等有机溶剂,生产成本高,防爆防火措施要求严格、安全隐患大,在生产过程中药物挥发多,生产厂房和设备投资大,不能生药粉直接入药;本发明采用热熔压敏胶作为基质,其属于热塑橡胶,有以下优势:
1、相对于常规橡胶基质,无需汽油,生产安全、环保,且生产效率高,生产成本低。
2、载药量大,药物释放性好,疗效好。
3、使用方便,粘附力适中,皮肤过敏概率小,患者依从性更好。
4、可生药粉直接入药,工艺简明可控。
综上所述,热熔压敏胶作为基质明显优于橡胶基质,且符合传统制剂备案的基本条件,因此选择其作为本品的基质。
S4,膏体冷却至80℃-90℃,将冰片、人工麝香、薄荷脑共研成粉状加入至膏体进行搅拌,搅拌0.5h,搅拌均匀即可得到外用药膏;
透皮吸收促进剂(Penetration enhancers,PE)是指一种具有能暂时性调节经皮通透性的物质,PE在应用安全无毒的前提下,在临床上能够增强或者提高药物的经皮穿透速率,甚至通过皮肤局部给予就能够有利于治疗病人全身性疾病。而贴膏剂常用透皮吸收促进剂有冰片、合成樟脑、薄荷脑、月桂氮酮等。目前有关单一PE的研究已经较多,本发明发现薄荷脑在一定浓度范围内能够促进葛根素的渗透,当浓度达到5mg/mL时具有显著促渗作用;3%薄荷脑加3%冰片对青藤碱微乳体外透皮吸收优于单独使用冰片及薄荷脑;5%冰片能将钩藤中钩藤碱透皮速率提高2.24倍,5%薄荷脑能将钩藤碱透皮速率提高1.95倍;冰片和薄荷油对蛇床子素的促渗效果均优于相同用量的氮酮。
PE的促渗能力与药物的理化性质有关,单一PE不能同时提高中药复方中多种有效成分的透皮能力,因此联合使用PE是当前中药贴膏剂透皮促渗的研究热点,研究发现部分PE按一定比例组合时能够取得协同作用,比使用单一PE效果更佳,在不同促渗剂复方红茴香喷雾剂体外透皮吸收的影响研究中指出对槲皮苷的累积渗透及渗透速率影响大小为冰片>薄荷油>氮酮>PEG400,天然透皮促渗其毒性小于合成的促渗透剂,从而得到联合PE对药物的透皮吸收效果更佳,故本品选择冰片、薄荷脑两种天然PE联合使用,以促进药物吸收,提高疗效。
本发明的外用中药复方制剂选择冰片、薄荷脑两种天然透皮吸收促进剂联合使用,冰片的熔点在206℃-209℃、沸点在212℃,薄荷脑的熔点在34℃-36℃、沸点在215℃,人工麝香其主要成分的麝香酮的沸点在130℃-329℃,但其他成分沸点较低,考虑到高温会使薄荷脑、麝香受热流失,故控制温度为80℃-90℃,将冰片、薄荷脑、人工麝香共研成粉末加入,搅拌0.5h后,即可搅拌均匀。
S5,保持温度80℃-85℃,将药膏摊涂于双向拉伸聚丙烯珠光薄膜上,涂布厚度控制在0.75mm-1.25mm,覆盖医用离型纸,卷成大药卷,并冷却至室温;
S6,将大药卷切制成大小合适的小药卷;
S7,将切好的药卷置贴合机上,贴合于带粘性的卫生用水刺法非织造布上,覆盖一层医用离型纸,切制成合适大小,包装。
本发明在外用中药复方制剂制备过程中,处方临床用法为药材粉碎后,加凡士林搅拌均匀,摊与纱布上,涂抹于患处;在使用过程中,患者反馈凡士林容易通过纱布渗出,污染衣物,同时可能引起患处痤疮。随着医药工业的不断发展,贴膏剂在我国的医药市场上逐渐得到广泛的应用,以其载药量大、透皮效果好、透气性好、皮肤刺激性小等特点,成为理想的透皮给药载体,因此本发明的剂型选择贴膏剂。
贴膏可分为凝胶贴膏和橡胶贴膏。凝胶贴膏指原料药物与适宜的亲水性基质混匀后涂布于背衬材料上制成的贴膏剂。常用基质有聚丙烯酸钠、羧甲纤维素钠、明胶、甘油和微粉硅胶等。实际生产中凝胶贴膏生产工艺复杂,生产周期长,膏体含水量高且黏弹性不足,使用中会因体温升高发生熔化,导致跑膏和脱膏,且容易导致过敏;凝胶贴膏放置时间过长,膏体易失水而硬化,导致无法敷贴。橡胶贴膏生产工艺相对简单,生产周期短,皮肤过敏概率小,使用时不受温度影响,保存时间长,故本发明采用橡胶贴膏。
本发明的外用中药复方制剂利用热熔压敏胶与药粉搅拌时的高温进行灭菌。
按处方比例称取药材适量,将药材粉碎成细粉后,称取50g,加入到融化热熔压敏胶中,将药粉完全加入后,温度控制在120℃,分别于0.5h、1h、1.5h取样,照《中国药典》2020年版四部贴膏剂检查项下微生物限度进行检测,考查到达贴膏剂灭菌标准所用的时间,结果见表3。
表3生药粉灭菌的考查
结果表明,药粉在120℃的热熔压敏胶中搅拌0.5h,可到达灭菌作用,按微生物限度要求检测合格。
本发明的外用中药复方制剂是通过局部麻醉,改善肿瘤周围组织血液循环及直接抗肿瘤作用而发挥缓解疼痛的作用。该药镇痛疗效显著,作用持久,能明显减轻患者痛苦,提高生存质量,且使用安全,无毒副作用,是治疗癌性疼痛的理想外用中成药。
实施例1
处方:大黄:27.44g、紫花地丁:16.48g、川芎:27.44g、全蝎:16.48g、蟾酥:1.64g、蚤休:32.92g、山慈菇:32.92g、姜黄:27.28g、人工麝香:0.56g、冰片:5.48g、红花:21.96g、桃仁:27.44g、当归:27.44g、龙血竭:16.48g、莪术:27.44g、蜈蚣:16.48g、桂枝:32.92g、制乳香:16.48g、没药:16.48g、细辛:8.24g、薄荷脑:1g、热熔压敏胶590.94g、。
工艺:将称取的冰片、人工麝香两味药材取出备用;将蟾酥粗碎或剪碎后,与大黄、紫花地丁、川芎、全蝎、蚤休、山慈菇、姜黄、红花、桃仁、当归、龙血竭、莪术、蜈蚣、桂枝、制乳香、没药、细辛十七味药材60℃干燥至含水量8%以下,混合粉碎成细粉;将热熔压敏胶在135℃-145℃温度下完全融化,控制温度为120℃-130℃,加入细粉搅拌1.5h-2h,搅拌均匀;待膏体冷却至80℃-90℃,将冰片、人工麝香、薄荷脑共研成粉状加入至膏体进行搅拌,搅拌0.5h,搅拌均匀;保持温度80℃-85℃,将药膏摊涂于双向拉伸聚丙烯珠光薄膜上,涂布厚度控制在0.75mm-1.25mm,覆盖医用离型纸,卷成大药卷,并冷却至室温;将大药卷切制成大小合适的小药卷;将切好的药卷置贴合机上,贴合于带粘性的卫生用水刺法非织造布上,覆盖一层医用离型纸,切制成合适大小,包装。
用法用量:外敷方式进行止痛治疗,根据人体疼痛位置可同时使用≥2贴,每贴作用时效8-6小时/次,使用方法2-3次/天,达到持续止痛的作用。如有外敷料过敏患者可减少外敷时长和使用次数。
实施例2
处方:大黄:28.126g、紫花地丁:16.892g、川芎:28.126g、全蝎:16.892g、蟾酥:1.681g、蚤休:33.743g、山慈菇:33.743g、姜黄:27.962g、人工麝香:0.574g、冰片:5.617g、红花:22.509g、桃仁:28.126g、当归:28.126g、龙血竭:16.892g、莪术:28.126g、蜈蚣:16.892g、桂枝:33.743g、制乳香:16.892g、没药:16.892g、细辛:8.446g、薄荷脑:1g、热熔压敏胶605.714g。
工艺和用法用量同实施例1。
实施例3
处方:大黄:28.812g、紫花地丁:17.304g、川芎:28.812g、全蝎:17.304g、蟾酥:1.722g、蚤休:34.566g、山慈菇:34.566g、姜黄:28.644g、人工麝香:0.588g、冰片:5.754g、红花:23.058g、桃仁:28.812g、当归:28.812g、龙血竭:17.304g、莪术:28.812g、蜈蚣:17.304g、桂枝:34.566g、制乳香:17.304g、没药:17.304g、细辛:8.652g、薄荷脑:1g、热熔压敏胶620.487g。
工艺和用法用量同实施例1。
实施例4
处方:大黄:29.498g、紫花地丁:17.716g、川芎:29.498g、全蝎:17.716g、蟾酥:1.763g、蚤休:35.389g、山慈菇:35.389g、姜黄:29.326g、人工麝香:0.602g、冰片:5.891g、红花:23.607g、桃仁:29.498g、当归:29.498g、龙血竭:17.716g、莪术:29.498g、蜈蚣:17.716g、桂枝:35.389g、制乳香:17.716g、没药:17.716g、细辛:8.858g、薄荷脑:1g、热熔压敏胶635.201g。
工艺和用法用量同实施例1。
实施例5
处方:大黄:30.184g、紫花地丁:18.128g、川芎:30.184g、全蝎:18.128g、蟾酥:1.804g、蚤休:36.212g、山慈菇:36.212g、姜黄:30.008g、人工麝香:0.616g、冰片:6.028g、红花:24.156g、桃仁:30.184g、当归:30.184g、龙血竭:18.128g、莪术:30.184g、蜈蚣:18.128g、桂枝:36.212g、制乳香:18.128g、没药:18.128g、细辛:9.064g、薄荷脑:1g、热熔压敏胶650.034g、。
工艺和用法用量同实施例1。
实施例6
处方:大黄:30.87g、紫花地丁:18.54g、川芎:30.87g、全蝎:18.54g、蟾酥:1.845g、蚤休:37.035g、山慈菇:37.035g、姜黄:30.69g、人工麝香:0.63g、冰片:6.165g、红花:24.705g、桃仁:30.87g、当归:30.87g、龙血竭:18.54g、莪术:30.87g、蜈蚣:18.54g、桂枝:37.035g、制乳香:18.54g、没药:18.54g、细辛:9.27g、薄荷脑:1g、热熔压敏胶664.808g。
工艺和用法用量同实施例1。
对比例1
处方:紫花地丁:18.00g、川芎:30.87g、全蝎:18.54g、蚤休:35.035g、山慈菇:37.035g、姜黄:30.69g、冰片:6.165g、红花:24.705g、桃仁:30.87g、当归:30.87g、龙血竭:28.54g、莪术:30.87g、蜈蚣:10.20g、桂枝:40.035g、制乳香:30.54g、没药:30.54g、细辛:9.27g、薄荷脑:1g、热熔压敏654.915g。
工艺:将称取的冰片取出备用;将紫花地丁、川芎、全蝎、蚤休、山慈菇、姜黄、红花、桃仁、当归、龙血竭、莪术、蜈蚣、桂枝、制乳香、没药、细辛十六味药材60℃干燥至含水量8%以下,混合粉碎成细粉;将热熔压敏胶在135℃-145℃温度下完全融化,控制温度为120℃-130℃,加入细粉搅拌1.5h-2h,搅拌均匀;待膏体冷却至80℃-90℃,将冰片、薄荷脑共研成粉状加入至膏体进行搅拌,搅拌0.5h,搅拌均匀;保持温度80℃-85℃,将药膏摊涂于双向拉伸聚丙烯珠光薄膜上,涂布厚度控制在0.75mm-1.25mm,覆盖医用离型纸,卷成大药卷,并冷却至室温;将大药卷切制成大小合适的小药卷;将切好的药卷置贴合机上,贴合于带粘性的卫生用水刺法非织造布上,覆盖一层医用离型纸,切制成合适大小,包装。
用法用量:外敷方式进行止痛治疗,根据人体疼痛位置可同时使用≥2贴,每贴作用时效8-6小时/次,使用方法2-3次/天,达到持续止痛的作用。如有外敷料过敏患者可减少外敷时长和使用次数。
对比例2
处方:紫花地丁:20.00g、川芎:50.87g、全蝎:20.54g、蚤休:35.035g、山慈菇:37.035g、姜黄:30.69g、冰片:6.165g、红花:30.705g、桃仁:30.87g、当归:30.87g、龙血竭:28.54g、莪术:30.87g、蜈蚣:10.20g、桂枝:40.035g、制乳香:30.54g、没药:30.54g、细辛:9.27g、薄荷脑:1g、热熔压敏胶699.915g。
工艺和用法用量同实施例7。
对比例1去掉了大黄、蟾酥、人工麝香三味药材,增加了龙血竭、桂枝、制乳香、没药的用量,减少了蜈蚣的用量,其制得膏药的止痛效果与实施例相比明显变弱,止痛时间也明显缩短;对比例2去掉了大黄、蟾酥、人工麝香三味药材,增加了地丁、川芎、全蝎、冰片的用量,其制得膏药的止痛效果没有实施例、对比例1的效果显著,止痛时间也明显缩短。
(一)药效学实验
一、镇痛实验:热板法对小鼠痛阀的影响
将各雌性小鼠置于55±0.2℃测痛仪的热板上测定正常痛闽值,以小鼠舔后足所需时间为痛阀出现的指标,取痛阀值在5-30秒之同小鼠40只,每只测其正常痛阈值二次,取其均值为该鼠给药前的正常痛阀值。将小鼠随机分为4组,每组10只,治疗组1(本发明外用中药复方制剂,涂药2cm2),治疗组2(本发明外用中药复方制剂,涂药1cm2),蟾酥膏组(涂药膏2cm2),对照组(涂蒸馏水)。给药每天一次,连续5天,于末次给药后30分钟、60分钟、90分钟各测一次每组动物的痛阈值,并与给药前比较,结果见表4。
表4本发明外用中药复方制剂对小鼠痛阈(秒)及对致痛小鼠扭体反应(次)的影响
注:※、※※与对比组比较P<0.05、0.01
结果表明本发明外用中药复方制剂和蟾酥膏均能明显提高小鼠的痛阈(与对照组比较,P<0.05及P<0.01),具有明显的镇痛作用,且本发明外用中药复方制剂的高剂量组(治疗组1)有强于蟾酥膏组的趋势。
二、扭体法对小鼠醋酸扭体反应的影响
取小鼠40只,雌雄各半,随机分为4组,每组10只,对照组给药凡士林2cm2,治疗组1(本发明外用中药复方制剂,给药2cm2),治疗组2(本发明外用中药复方制剂,给药1cm2),蟾酥膏组给药2cm2,4组均涂布给药,每天一次,连续5天,于末次给药后30分钟各鼠腹腔注射0.6%冰醋酸0.2m1/20g,记录注射致痛剂后15分钟内各鼠扭体反应(腹部内凹、伸屈后腿、臀部抬高)次数,计数扭体反应抑制率,结果见表5。
结果表明,治疗组1(本发明外用中药复方制剂大剂量组)、治疗组2(本发明外用中药复方制剂小剂量组)、蟾酥膏组均能明显降低醋酸所致小鼠的扭体反应次数(与对照组比较,P<0.05),具有明显的镇痛作用。
三、对小鼠扭体模型的血液及给药局部皮肤的NO及PGE2的影响
取小鼠50只,小鼠腹部用10%硫化钠细胞脱毛后,分为5组,每组10只,治疗组1(本发明外用中药复方制剂,腹部涂药2cm2),治疗组2(本发明外用中药复方制剂,腹部涂药1cm2),蟾酥膏组取膏2cm2贴腹部,模型对照组及正常对照组均用凡士林涂腹部2cm2,各组均每日给药一次,各鼠单笼饲养,连续涂药3天后,除正常对照组小鼠腹腔等剂量注射生理盐水外,其它各组小鼠均腹腔注射0.6%水醋酸0.1m1/10g致痛,记录各组20分钟内的扭体次数。致痛后继续用药两天后,取小鼠眼球采血约2m1,并断头处死小鼠,小鼠致死后立即用扭力天平称取小鼠涂药处皮肤500mg,加5ml生理盐水,在低温下剪碎后,用玻璃匀浆器匀浆,然后3000rpm低温离心10min,取上清液用r计数仪检测NO、PGE2,结果见表6。
※、※※与模型对照组比较P<0.05、0.01
Δ、ΔΔ与正常对照组比较P<0.05、0.01
结果显示,本发明外用中药复方制剂能提高致痛小鼠血清及贴药局部的NO含量,降低PGE2含量,尤其对贴药局部皮肤影响明显。
(二)临床实验:
1.观察对象:选择已确诊为恶性肿瘤且伴有癌性疼痛的患者60例,随机数表法分为治疗组30例,对照组30例。
2.治疗方法:临床研究根据随机分组,两组均用单盲法给药外敷,治疗组采用本发明外用中药复方制剂,由湖南省中医药研究院附属医院制剂室生产,批号是980615;对照组采用蟾酥膏,由上海中药三厂生产。使用前先洗净患处皮肤,然后取膏药一张,烘热软化,贴敷肿痕检部或疼痛郁位,并用手轻轻在膏药上按降3~5分钟,24小时更换一次,7天为一疗程。以本发明外用中药复方制剂与蟾酥膏对照治疗,观察疼痛程度,止痛起效时间、持续时间,生存质量的KPS(卡氏)功能状态评分及治疗前后外周血象,肝、肾动能,心电图,局部皮肤有无刺激、过敏反应等安全性指标;
3.试验目的:确定其治疗癌性疼痛的临床疗效,探讨该药的药理和毒理。
4.试验结果:临床结果显示,治疗组止痛总有效率、止痛持续时间、生存质量的KPS(卡氏)功能状态评分均明显高于对照组,结果见表7、表8。
表7治疗后两组止痛疗效
总有效率=(显效+有效)/例数;*P<0.05
※、※※组内前后比较P<0.05、0.01
Δ、ΔΔ组间比较P<0.05、0.01
临床试验结果显示本发明的外用中药复方制剂治疗后疼痛总分较治疗前明显降低(P<0.01),治疗组止痛总有效率(93.33%)明显高于对照组(70%,P<0.05);本发明的外用中药复方制剂止痛的平均持续时间为16.6h,较对照组的10.97h明显延长(P<0.05);本发明的外用中药复方制剂治疗后生存质量的KPS(卡氏)功能状态评分明显高于治疗前(P<0.05),治疗组KPS(卡氏)功能状态评分提高,其稳定率为86.67%,明显优于对照组(73.33%,P<0.05),而对外周血象、心、肝、肾功能及皮肤均无明显损害。
5.试验结论:本发明的外用中药复方制剂对癌性疼痛作用显著、持久,能明显减轻患者痛苦,提高了生存质量。解毒化瘀,行气止痛是癌性疼痛的有效治疗方法,本发明的外用中药复方制剂是治疗癌性疼痛的有效药物。
(三)毒性实验
一、对小鼠S180肉瘤的抑制实验
无菌条件下抽取S180肉瘤瘤液,将S180肉瘤瘤液和生理盐水体积分数比为1:3进行稀释得到小鼠肿瘤无菌稀释液,取18~22gNIH小鼠,每批实验单用一种性别,于左腋按无菌操作皮下接种小鼠肿瘤无菌稀释液0.2m1/只,24小时后称重。随机分组为荷瘤对照组(动物数多一倍),治疗组1(本发明外用中药复方制剂大剂量组,涂布腹部面积2cm2),治疗组2(本发明外用中药复方制剂小剂量组,涂布腹部面积1cm2),环磷酰胺组(环磷酰胺每日20mg/kg),荷瘤对照组每日予等容积蒸瘤水。每日一次,连续7天,停药次日处死小鼠,称重并剥高皮下瘤块,称痕重,统计死亡率、体重、瘤重,并计算抑制率,本实验重复三批,结果见表9。
表9本发明外用中药复方制剂对小鼠S180肉瘤的影响
※、※※组内前后比较P<0.05、0.01
Δ、ΔΔ组间比较P<0.05、0.01
结果显示,本发明外用中药复方制剂大、小剂量组对S180肉瘤的抑制率三批结果相近,本发明外用中药复方制剂对S180肉瘤表现出较好的抑制活性(与荷瘤模型组比较,P<0.01),抑瘤率>30%。大剂量组最大抑瘤率达41.6%。
实验结论:本发明的外用中药复方制剂对小鼠S180肉瘤有较强、较稳定的抑制作用。
二、对小鼠H22肝癌腹水瘤的抑制实验
选择接种7天后腹水生长良好的NIH小鼠、灭菌抽取吸腹水,将吸腹水和生理盐水体积分数比为1:3进行稀释得到腹水稀释液,取18-22gNIH小鼠,每一批用单一性别,于腹腔接种腹水稀释液0.2m1/只,24小时后称重分组,随机分为4组,治疗组1(本发明外用中药复方制剂大剂量组,腹部涂药2cm2),治疗组2(本发明外用中药复方制剂小剂量组,腹部涂药1cm2),环磷酰胺(CTX)对照组每日注射CTX20mg/kg,荷瘤模型对照组以等容积蒸馏水腹腔注射,每日一次,连续7天,停药后称体重一次,作为治疗后体重,并开始观察动物的生存日数,计算生命延长率,本试验重复三批,结果见表10。
表10本发明外用中药复方制剂对小鼠H22肝癌腹水瘤的影响
组别 | 治疗后体重(g) | 生存日数(天) | 生命延长率(%) |
治疗组1 | 25.48±11.31<sup>※</sup> | 40 | 57.50±10.70<sup>ΔΔ</sup> |
治疗组2 | 25.70±11.03<sup>※</sup> | 39 | 56.10±10.10<sup>△</sup> |
荷瘤对照组 | 31.50±11.38 | 20 | 20.50±6.30 |
环磷酰胺对照组 | 24.10±10.70<sup>※</sup> | 47 | 58.50±11.38 |
※、※※组内前后比较P<0.05、0.01
Δ、ΔΔ组间比较P<0.05、0.01
结果显示,本发明外用中药复方制剂大、小剂量组对小鼠H22肝癌腹水瘤有一定抑制作用,与荷瘤对照组比较,本发明外用中药复方制剂大剂量组能明显延长小鼠存活时间(P<0.01)。
实验结论:本发明的外用中药复方制剂对小鼠H22肝癌腹水瘤有一定抑制作用,能明显延长荷瘤小鼠存活时间。
三、通过本发明的外用中药复方制剂对家兔完整皮肤和破损皮肤的急性毒性实验,对皮肤的刺激实验以及对皮肤的过敏实验的观察,本发明的外用中药复方制剂对家兔完整皮肤无刺激作用,对家兔破损皮肤有一定的刺激作用。结果表明本发明的外用中药复方制剂对皮肤用药无急性毒性反应,无致敏性。
综上,本发明的外用中药复方制剂是通过局部麻醉,改善肿瘤周围组织血液循环及直接抗肿瘤作用而发挥缓解疼痛的作用。该外用中药复方制剂镇痛疗效显著,作用持久,能明显减轻患者痛苦,提高生存质量的KPS(卡氏)功能状态评分,且使用安全,无毒副作用,是治疗癌性疼痛的理想外用中成药。
本说明书中的各个实施例均采用相关的方式描述,各个实施例之间相同相似的部分互相参见即可,每个实施例重点说明的都是与其他实施例的不同之处。尤其,对于系统实施例而言,由于其基本相似于方法实施例,所以描述的比较简单,相关之处参见方法实施例的部分说明即可。
以上所述仅为本发明的较佳实施例而已,并非用于限定本发明的保护范围。凡在本发明的精神和原则之内所作的任何修改、等同替换、改进等,均包含在本发明的保护范围内。
Claims (4)
1.一种降低癌性疼痛的外用中药复方制剂,其特征在于,所述外用中药复方制剂由以下重量份数的原料有效成分组成:大黄2.744~3.087份,紫花地丁1.648~1.854份,川芎2.744~3.087份,全蝎1.648~1.854份,蟾酥0.164~0.1845份,蚤休3.292~3.7035份,山慈菇3.292~3.7035份,姜黄2.728~3.069份,人工麝香0.056~0.063份,冰片0.548~0.6165份,红花2.196~2.4705份,桃仁2.744~3.087份,当归2.744~3.087份,龙血竭1.648~1.854份,莪术2.744~3.087份,蜈蚣1.648~1.854份,桂枝3.292~3.7035份,制乳香1.648~1.854份,没药1.648~1.854份,细辛0.824~0.927份,薄荷脑0.1份组成。
2.一种降低癌性疼痛的外用中药复方制剂的制备方法,其特征在于,包括以下步骤:
S1,按照以下重量份数分别称取药材:大黄2.744~3.087份,紫花地丁1.648~1.854份,川芎2.744~3.087份,全蝎1.648~1.854份,蟾酥0.164~0.1845份,蚤休3.292~3.7035份,山慈菇3.292~3.7035份,姜黄2.728~3.069份,人工麝香0.056~0.063份,冰片0.548~0.6165份,红花2.196~2.4705份,桃仁2.744~3.087份,当归2.744~3.087份,龙血竭1.648~1.854份,莪术2.744~3.087份,蜈蚣1.648~1.854份,桂枝3.292~3.7035份,制乳香1.648~1.854份,没药1.648~1.854份,细辛0.824~0.927份,薄荷脑0.1份;热熔压敏胶作为基质,其重量份是蟾酥、大黄、紫花地丁、川芎、全蝎、蚤休、山慈菇、姜黄、红花、桃仁、当归、龙血竭、莪术、蜈蚣、桂枝、制乳香、没药、细辛十八味药材重量的1-1.5倍;
S2,将称取的冰片、人工麝香两味药材取出备用;将蟾酥粗碎或剪碎后,与大黄、紫花地丁、川芎、全蝎、蚤休、山慈菇、姜黄、红花、桃仁、当归、龙血竭、莪术、蜈蚣、桂枝、制乳香、没药、细辛十七味药材60℃干燥至含水量8%以下,混合粉碎成细粉;
S3,将热熔压敏胶在135℃-145℃温度下完全融化,控制温度为120℃-130℃,加入S2所得细粉进行搅拌,搅拌均匀;
S4,膏体冷却至80℃-90℃,将冰片、人工麝香、薄荷脑共研成粉状加入至膏体进行搅拌,搅拌均匀即可得到外用药膏;
S5,保持温度80℃-85℃,将药膏摊涂于双向拉伸聚丙烯珠光薄膜上,涂布厚度控制在0.75mm-1.25mm,覆盖医用离型纸,卷成大药卷,并冷却至室温;
S6,将大药卷切制成大小合适的小药卷;
S7,将切好的药卷置贴合机上,贴合于带粘性的卫生用水刺法非织造布上,覆盖一层医用离型纸,切制成合适大小,包装。
3.根据权利要求2所述的一种降低癌性疼痛的外用中药复方制剂的制备方法,其特征在于,所述S3中搅拌时间为1.5h-2h。
4.根据权利要求2所述的一种降低癌性疼痛的外用中药复方制剂的制备方法,其特征在于,所述S4中搅拌时间为0.5h。
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