CN106620530A - 一种治疗癌性疼痛的癌痛贴 - Google Patents
一种治疗癌性疼痛的癌痛贴 Download PDFInfo
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Abstract
本发明涉及治疗癌性疼痛的癌痛贴,有效解决癌性疼痛的治疗问题,由以下原料药物制成:乳香、没药、夏枯草、延胡索、甘松、丁香、半夏、冰片、芒硝、莪术、土贝母、山慈菇、徐长卿和细辛,冰片、没药、乳香研细末,过筛;其余原料药物混合,加酒精浸泡,过滤,药渣加水,煎熬两次,合并两次煎熬药液,浓缩,倒入过滤液,搅匀,混合,静置,过滤,浓缩至提取液;制松香基质,去火毒,得基质;将基质、提取液、没药细粉、乳香细粉、冰片细粉制成膏料;倒入膏药布的防渗圈内,即得。本发明配伍科学,方法简单,成本低,效果好。
Description
技术领域
本发明涉及中医药领域,特别是一种治疗癌性疼痛的癌痛贴。
背景技术
癌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,也被认为是癌痛。癌痛是造成癌晚期患者主要痛苦的原因之一。癌痛一般以药物治疗为主,手术治疗往往需要结合病人的总体身体状况及生存期考虑。对于可能治愈的癌症患者,确切有效的止痛可以明显改善病人的一般情况,使其顺利地完成临床放疗、化疗等抗肿瘤治疗计划,达到治愈的目的。对于难以治愈的患者,有效的止痛可以使其获得较为舒适的带瘤生存,提高其生存质量,并可能延长其生存期。事实上,让癌症患者无痛或尽量使疼痛减轻到可以耐受的程度是完全能够做到的。根据WHO公布的资料,单纯使用止痛药物可使90%的疼痛得到不同程度的缓解。
疼痛是肿瘤患者最常见却又最难控制的症状之一。据世界卫生组织(WHO)统计,全世界每年有1000万新发癌症患者,600万人死于癌症,其中50%的患者有癌痛症状,70%的晚期癌症患者以疼痛为主要症状。在疼痛患者中,因各种原因使50%~80%的疼痛没有得到有效控制。当前,我国每年新发癌症患者数约180万,每年死于癌症的人数达到140万。研究表明,我国癌痛病人发病率高达50%左右,疼痛的原因以肿瘤直接引起的疼痛占第1位约占80%,同时治疗肿瘤也可引起疼痛,发生率占10%左右。其他10%为与肿瘤相关或无关原因。
中医在阐述癌性疼痛的病机主要有正气亏虚、癌毒内蕴、痰瘀互结、经络壅塞等,这些病机相互为因、相互影响、相互转化。如《临证指南医案》云:“积伤入络,气血皆淤,则流行失司,所谓痛则不通”,说明气滞血瘀是导致癌性疼痛主要机制之一;例如《肘后备急方》云:“治痤暴症,腹中有物如石,痛如刺,昼夜啼呼,不治之,百日死”,说明癌痛难以忍受,对病人生存质量影响较大。因此,只有全面深刻的认识这些病机,了解病人的疾苦,才能更有效缓解病人的痛苦。目前已认识到癌性疼痛是一类全身疾病的局部表现,现缓解癌性疼痛的西药种类繁多,或因其疗效欠佳、或因其成瘾性、或因其不良反应众多,故应用时顾虑甚多。而中医方面颇有优势在恶性肿瘤进展期,患者往往出现恶心、呕吐、腹胀、痞满、食欲下降、食水不进等顽固性的消化系统症状,此时口服中药治疗有相当难度,同时,由于肿瘤后期患者正气亏虚,患者体质极差,常用的活血止痛、软坚逐瘀药物通过口服方式对人体正气伤害较大,患者无法承受其带来的各种不良反应,使治疗上顾此失彼、进退维谷,造成困难,故中药外治疗法在治疗癌性疼痛方面更是具有其优势。而中药外治法因为其疗效明显、无创伤、易接受、无麻方的成瘾性等特点,受到临床医师的重视。中药外治的常规用药方式有:透皮给药、敷脐疗法、穴位注射、灌肠法、离子导入法、熏洗法,常用的中药外治剂型有膏剂、散剂、酒剂、酊剂、贴剂、巴布剂等等,那么能研制一种治疗癌痛的外用中药呢?是当前迫切需要解决的问题。
发明内容
针对上述情况,为克服现有技术之缺陷,本发明之目的就是提供一种治疗癌性疼痛的癌痛贴,可有效解决癌性疼痛的治疗问题。
本发明的技术方案是:由以下重量计的原料药物制成:乳香27-33g、没药27-33g、夏枯草27-33g、延胡索27-33g、甘松18-22g、丁香9-11g、半夏18-22g、冰片9-11g、芒硝27-33g、莪术27-33g、土贝母27-33g、山慈菇27-33g、徐长卿27-33g和细辛9-11g,制备步骤如下:
1)、将冰片、没药、乳香分别研细末,过120目筛,得冰片细粉、没药细粉和乳香细粉;
2)、其余的11味原料药物混合,加入质量浓度95%的酒精,浸没,浸泡15天,过滤,过滤液备用;
3)、过滤后的药渣加水,煎熬两次,每次水的加入量为除冰片、没药和乳香外的其余11味原料药物总重量的3倍,每次煎熬1小时,合并两次煎熬所得药液后,在140℃-150℃温度下,浓缩至200-300ml,倒入上述过滤液,搅拌均匀,混合,静置24小时,过滤,滤液在140℃-150℃温度下,浓缩至300ml的提取液;
4)、取香油加热至60℃-80℃,在搅拌下加入松香,香油和松香的重量比为20:100,松香加完后,再继续沿一个方向搅拌30-40分钟,即得松香基质;
5)、松香基质静置15-25分钟后,浸没于大于5℃小于30℃的水中,顺时针搅动30-40分钟,使松香基质冷却,将冷却的松香基质拧成坨,然后浸没于大于5℃小于30℃的水中7-10天,每日换水2次,即得基质(此过程是为了去火毒);
6)、取基质置锅内,在140℃-150℃下加热,溶化,直至水泡完全消失(如有水泡,即存水气,待泡沫消失后即已去尽水气);
7)、再在220-230℃下继续加热,边搅拌边加入上述3)步骤所得的提取液,基质与提取液的体积比为120:80,加热30-40分钟,再冷却至60-70℃,加入没药细粉和乳香细粉,搅匀,冷却至40℃,加入冰片细粉,搅匀,即成膏料;
8)、将膏料倒入膏药布的防渗圈内,防渗圈内的膏料为20g,即成膏药。
要指出的是,本发明的核心和关健在于组方及配伍量,凡是采用本组方及配伍量,不管是采用什么方法制成的其它剂型,均属于本发明的保护范围,本发明配伍科学,方法简单,成本低,效果好,是中医药上的一大创造。
具体实施方式
以下结合实际情况对本发明的具体实施方式作详细说明。
实施例1
本发明由以下重量计的原料药物制成:乳香30g、没药30g、夏枯草30g、延胡索30g、甘松20g、丁香10g、半夏20g、冰片10g、芒硝30g、莪术30g、土贝母30g、山慈菇30g、徐长卿30g和细辛10g,制备步骤如下:
1)、将冰片、没药、乳香分别研细末,过120目筛,得冰片细粉、没药细粉、乳香细粉;
2)、其余的11味原料药物混合,加入质量浓度95%的酒精,浸没,浸泡15天,过滤,过滤液备用;
3)、过滤后的药渣加水,煎熬两次,每次水的加入量为除冰片、没药和乳香外的其余11味原料药物总重量的3倍,每次煎熬1小时,合并两次煎熬所得药液后,在145℃温度下,浓缩至250ml,倒入上述过滤液,搅拌均匀,混合,静置24小时,过滤,滤液在145℃温度下,浓缩至300ml的提取液;
4)、取香油加热至70℃,在搅拌下加入松香,香油和松香的重量比为20:100,松香加完后,再继续沿一个方向搅拌35分钟,即得松香基质;
5)、松香基质静置15分钟后,浸没于18℃的水中,顺时针搅动30分钟,使松香基质冷却,将冷却的松香基质拧成坨,然后浸没于17℃的水中8天,每日换水2次,即得基质(此过程是为了去火毒);
6)、取基质置锅内,在145℃下加热,溶化,直至水泡完全消失(如有水泡,即存水气,待泡沫消失后即已去尽水气);
7)、再在225℃下继续加热,边搅拌边加入上述3)步骤所得的提取液,基质与提取液的体积比为120:80,加热30分钟,再冷却至65℃,加入没药细粉和乳香细粉,搅匀,冷却至40℃,加入冰片细粉,搅匀,即成膏料;
8)、将膏料倒入膏药布的防渗圈内,防渗圈内的膏料为20g,即成膏药。
实施例2
本发明由以下重量计的原料药物制成:乳香27g、没药27g、夏枯草27g、延胡索27g、甘松18g、丁香9g、半夏18g、冰片9g、芒硝27g、莪术27g、土贝母27g、山慈菇27g、徐长卿27g和细辛9g,制备步骤如下:
1)、将冰片、没药、乳香分别研细末,过120目筛,得冰片细粉、没药细粉、乳香细粉;
2)、其余的11味原料药物混合,加入质量浓度95%的酒精,浸没,浸泡15天,过滤,过滤液备用;
3)、过滤后的药渣加水,煎熬两次,每次水的加入量为除冰片、没药和乳香外的其余11味原料药物总重量的3倍,每次煎熬1小时,合并两次煎熬所得药液后,在140℃温度下,浓缩至200ml,倒入上述过滤液,搅拌均匀,混合,静置24小时,过滤,滤液在140℃温度下,浓缩至300ml的提取液;
4)、取香油加热至80℃,在搅拌下加入松香,香油和松香的重量比为20:100,松香加完后,再继续沿一个方向搅拌30分钟,即得松香基质;
5)、松香基质静置20分钟后,浸没于7℃的水中,顺时针搅动35分钟,使松香基质冷却,将冷却的松香基质拧成坨,然后浸没于8℃的水中7天,每日换水2次,即得基质(此过程是为了去火毒);
6)、取基质置锅内,在140℃下加热,溶化,直至水泡完全消失(如有水泡,即存水气,待泡沫消失后即已去尽水气);
7)、再在220℃下继续加热,边搅拌边加入上述3)步骤所得的提取液,基质与提取液的体积比为120:80,加热35分钟,再冷却至60℃,加入没药细粉和乳香细粉,搅匀,冷却至40℃,加入冰片细粉,搅匀,即成膏料;
8)、将膏料倒入膏药布的防渗圈内,防渗圈内的膏料为20g,即成膏药。
实施例3
本发明由以下重量计的原料药物制成:乳香33g、没药33g、夏枯草33g、延胡索33g、甘松22g、丁香11g、半夏22g、冰片11g、芒硝33g、莪术33g、土贝母33g、山慈菇33g、徐长卿33g和细辛11g,制备步骤如下:
1)、将冰片、没药、乳香分别研细末,过120目筛,得冰片细粉、没药细粉、乳香细粉;
2)、其余的11味原料药物混合,加入质量浓度95%的酒精,浸没,浸泡15天,过滤,过滤液备用;
3)、过滤后的药渣加水,煎熬两次,每次水的加入量为除冰片、没药和乳香外的其余11味原料药物总重量的3倍,每次煎熬1小时,合并两次煎熬所得药液后,在150℃温度下,浓缩至300ml,倒入上述过滤液,搅拌均匀,混合,静置24小时,过滤,滤液在150℃温度下,浓缩至300ml的提取液;
4)、取香油加热至60℃,在搅拌下加入松香,香油和松香的重量比为20:100,松香加完后,再继续沿一个方向搅拌40分钟,即得松香基质;
5)、松香基质静置25分钟后,浸没于28℃的水中,顺时针搅动40分钟,使松香基质冷却,将冷却的松香基质拧成坨,然后浸于29℃的水中10天,每日换水2次,即得基质(此过程是为了去火毒);
6)、取基质置锅内,在150℃下加热,溶化,直至水泡完全消失(如有水泡,即存水气,待泡沫消失后即已去尽水气);
7)、再在230℃下继续加热,边搅拌边加入上述3)步骤所得的提取液,基质与提取液的体积比为120:80,加热40分钟,再冷却至70℃,加入没药细粉和乳香细粉,搅匀,冷却至40℃,加入冰片细粉,搅匀,即成膏料;
8)、将膏料倒入膏药布的防渗圈内,防渗圈内的膏料为20g,即成膏药。
本发明组方中所用的原料药物均为市售中药饮片,本发明组方合理,应用安全,疗效好。具有活血化瘀、通络止痛、散结消癥之功效,是治疗癌性疼痛药物上的创新,并为临床资料所证明,本发明的有关临床资料如下:
一般资料:确诊为癌症疼痛的患者132例,随机分为本发明中药贴剂组、芬太尼透皮贴组。本发明中药贴剂组66例,男34例,女32例,年龄最大者60岁,最小者40岁。芬太尼透皮贴组66例,男34例,女32例,年龄最大者60岁,年龄最小者41岁。
癌症疼痛的分级标准:参照中华人民共和国卫生部2011年版《癌症疼痛诊疗规范》主诉疼痛程度分级法(VRS)的建议制定:
根据患者对疼痛的主诉,将疼痛分为轻度、中度、重度三类。
(1)轻度疼痛:有疼痛但可以忍受,生活正常,睡眠无干扰。
(2)中度疼痛:疼痛明显,不能忍受,要求服用镇痛药物,睡眠受干扰。
(3)重度疼痛:疼痛剧烈,不能忍受,需要镇痛药物,睡眠受严重干扰,可伴自主神经紊乱或被动体位。
纳入标准
患者治疗前疼痛程度为中重疼痛(NRS评分大于等于4分);预期生存时间6个月以上;疼痛部位未进行放射治疗、30日内未接受化学或免疫治疗;无阿片类药物过敏史以及滥用阿片类药物史,无伴随肿瘤急症。
排除标准
妊娠和哺乳患者;重症感染;非癌性发热;同时使用其他止痛方法;局部有破损者,不可将膏药直接贴在破损处,以免发生化脓性感染;如果贴膏药后局部皮肤出现丘疹、水疱,自觉瘙痒剧烈,说明对此膏药过敏,应立即停止贴敷;精神病患者;凡不符合纳入标准,未按规定用药,无法判断疗效或资料不全等影响疗效或安全性判断者。
治疗方案
本发明中药贴剂组(简称癌痛贴组)采用本发明癌痛贴,1贴/1次,局部贴敷,每3天更换一次,15天统计疗效。对照组为芬太尼透皮贴组(简称芬太尼组),2.1mg/贴,1贴/1次,疗程同本发明中药贴剂组。
疗效评定标准:
采用WHO疼痛疗效标准结合数字评分(NRS)法双重判定:完全缓解:完全无疼痛,NRS评分0分;(2)中度缓解:疼痛较前明显减轻,睡眠不受影响,NRS评分减少1/2-3/4;(3)轻度缓解:疼痛较前减轻,但仍明显疼痛,NRS评分减少小于1/2;(4)无效:疼痛较前无减轻,NRS评分无减少。总有效率=完全缓解+中度缓解+轻度缓解
结果:
表1两组患者用药后中度疼痛缓解情况比较
注:*P=0.029
表2两组患者用药后重度度疼痛缓解情况比较
注:*P=0.028
表3两组患者用药后不良反应发生率比较
由上表可知,癌痛贴组对中、重度疼痛的缓解总有效率分别为93.75%、94.12%,芬太尼透皮贴组的总有效率分别为73.33%、75.00%,癌痛贴组优于芬太尼透皮贴组,经统计学处理,有显著差异(P<0.05)。其中,癌痛贴组不良反应的发生率为9.09%,其中皮肤发痒者4例(6.06%),出现红疹2例(3.03%)。芬太尼透皮贴组出现恶心呕吐者6例(9.09%),便秘者8例(12.12%),皮肤瘙痒者4例(6.06%),头晕者4例(6.06%),嗜睡者2例(3.03%),不良反应总发生率为36.36%。经统计学分析,具有显著差异。
结论
综上所述,经临床试验表明,本发明癌痛贴组方科学合理,原料丰富,易生产制备,使用方便,具有血化瘀、通络止痛、散结消癥之功效,有效用于治疗癌性疼痛,疗效确切可靠,治疗效果优于芬太尼透皮贴组,且不良反应较芬太尼透皮贴组发生率低,具有很强的临床实际应用价值,有巨大的经济和社会效益。
Claims (4)
1.一种治疗癌性疼痛的癌痛贴,其特征在于,由以下重量计的原料药物制成:乳香27-33g、没药27-33g、夏枯草27-33g、延胡索27-33g、甘松18-22g、丁香9-11g、半夏18-22g、冰片9-11g、芒硝27-33g、莪术27-33g、土贝母27-33g、山慈菇27-33g、徐长卿27-33g和细辛9-11g,制备步骤如下:
1)、将冰片、没药、乳香分别研细末,过120目筛,得冰片细粉、没药细粉和乳香细粉;
2)、其余的11味原料药物混合,加入质量浓度95%的酒精,浸没,浸泡15天,过滤,过滤液备用;
3)、过滤后的药渣加水,煎熬两次,每次水的加入量为除冰片、没药和乳香外的其余11味原料药物总重量的3倍,每次煎熬1小时,合并两次煎熬所得药液后,在140℃-150℃温度下,浓缩至200-300ml,倒入上述过滤液,搅拌均匀,混合,静置24小时,过滤,滤液在140℃-150℃温度下,浓缩至300ml的提取液;
4)、取香油加热至60℃-80℃,在搅拌下加入松香,香油和松香的重量比为20:100,松香加完后,再继续沿一个方向搅拌30-40分钟,即得松香基质;
5)、松香基质静置15-25分钟后,浸没于大于5℃小于30℃的水中,顺时针搅动30-40分钟,使松香基质冷却,将冷却的松香基质拧成坨,然后浸没于大于5℃小于30℃的水中7-10天,每日换水2次,即得基质;
6)、取基质置锅内,在140℃-150℃下加热,溶化,直至水泡完全消失;
7)、再在220-230℃下继续加热,边搅拌边加入上述3)步骤所得的提取液,基质与提取液的体积比为120:80,加热30-40分钟,再冷却至60-70℃,加入没药细粉和乳香细粉,搅匀,冷却至40℃,加入冰片细粉,搅匀,即成膏料;
8)、将膏料倒入膏药布的防渗圈内,防渗圈内的膏料为20g,即得。
2.根据权利要求1所述的治疗癌性疼痛的癌痛贴,其特征在于,由以下重量计的原料药物制成:乳香30g、没药30g、夏枯草30g、延胡索30g、甘松20g、丁香10g、半夏20g、冰片10g、芒硝30g、莪术30g、土贝母30g、山慈菇30g、徐长卿30g和细辛10g,制备步骤如下:
1)、将冰片、没药、乳香分别研细末,过120目筛,得冰片细粉、没药细粉、乳香细粉;
2)、其余的11味原料药物混合,加入质量浓度95%的酒精,浸没,浸泡15天,过滤,过滤液备用;
3)、过滤后的药渣加水,煎熬两次,每次水的加入量为除冰片、没药和乳香外的其余11味原料药物总重量的3倍,每次煎熬1小时,合并两次煎熬所得药液后,在145℃温度下,浓缩至250ml,倒入上述过滤液,搅拌均匀,混合,静置24小时,过滤,滤液在145℃温度下,浓缩至300ml的提取液;
4)、取香油加热至70℃,在搅拌下加入松香,香油和松香的重量比为20:100,松香加完后,再继续沿一个方向搅拌35分钟,即得松香基质;
5)、松香基质静置15分钟后,浸没于18℃的水中,顺时针搅动30分钟,使松香基质冷却,将冷却的松香基质拧成坨,然后浸没于17℃的水中8天,每日换水2次,即得基质;
6)、取基质置锅内,在145℃下加热,溶化,直至水泡完全消失;
7)、再在225℃下继续加热,边搅拌边加入上述3)步骤所得的提取液,基质与提取液的体积比为120:80,加热30分钟,再冷却至65℃,加入没药细粉和乳香细粉,搅匀,冷却至40℃,加入冰片细粉,搅匀,即成膏料;
8)、将膏料倒入膏药布的防渗圈内,防渗圈内的膏料为20g,即得。
3.根据权利要求1所述的治疗癌性疼痛的癌痛贴,其特征在于,由以下重量计的原料药物制成:乳香27g、没药27g、夏枯草27g、延胡索27g、甘松18g、丁香9g、半夏18g、冰片9g、芒硝27g、莪术27g、土贝母27g、山慈菇27g、徐长卿27g和细辛9g,制备步骤如下:
1)、将冰片、没药、乳香分别研细末,过120目筛,得冰片细粉、没药细粉、乳香细粉;
2)、其余的11味原料药物混合,加入质量浓度95%的酒精,浸没,浸泡15天,过滤,过滤液备用;
3)、过滤后的药渣加水,煎熬两次,每次水的加入量为除冰片、没药和乳香外的其余11味原料药物总重量的3倍,每次煎熬1小时,合并两次煎熬所得药液后,在140℃温度下,浓缩至200ml,倒入上述过滤液,搅拌均匀,混合,静置24小时,过滤,滤液在140℃温度下,浓缩至300ml的提取液;
4)、取香油加热至80℃,在搅拌下加入松香,香油和松香的重量比为20:100,松香加完后,再继续沿一个方向搅拌30分钟,即得松香基质;
5)、松香基质静置20分钟后,浸没于7℃的水中,顺时针搅动35分钟,使松香基质冷却,将冷却的松香基质拧成坨,然后浸没于8℃的水中7天,每日换水2次,即得基质;
6)、取基质置锅内,在140℃下加热,溶化,直至水泡完全消失;
7)、再在220℃下继续加热,边搅拌边加入上述3)步骤所得的提取液,基质与提取液的体积比为120:80,加热35分钟,再冷却至60℃,加入没药细粉和乳香细粉,搅匀,冷却至40℃,加入冰片细粉,搅匀,即成膏料;
8)、将膏料倒入膏药布的防渗圈内,防渗圈内的膏料为20g,即得。
4.根据权利要求1所述的治疗癌性疼痛的癌痛贴,其特征在于,由以下重量计的原料药物制成:乳香33g、没药33g、夏枯草33g、延胡索33g、甘松22g、丁香11g、半夏22g、冰片11g、芒硝33g、莪术33g、土贝母33g、山慈菇33g、徐长卿33g和细辛11g,制备步骤如下:
1)、将冰片、没药、乳香分别研细末,过120目筛,得冰片细粉、没药细粉、乳香细粉;
2)、其余的11味原料药物混合,加入质量浓度95%的酒精,浸没,浸泡15天,过滤,过滤液备用;
3)、过滤后的药渣加水,煎熬两次,每次水的加入量为除冰片、没药和乳香外的其余11味原料药物总重量的3倍,每次煎熬1小时,合并两次煎熬所得药液后,在150℃温度下,浓缩至300ml,倒入上述过滤液,搅拌均匀,混合,静置24小时,过滤,滤液在150℃温度下,浓缩至300ml的提取液;
4)、取香油加热至60℃,在搅拌下加入松香,香油和松香的重量比为20:100,松香加完后,再继续沿一个方向搅拌40分钟,即得松香基质;
5)、松香基质静置25分钟后,浸没于28℃的水中,顺时针搅动40分钟,使松香基质冷却,将冷却的松香基质拧成坨,然后浸于29℃的水中10天,每日换水2次,即得基质;
6)、取基质置锅内,在150℃下加热,溶化,直至水泡完全消失;
7)、再在230℃下继续加热,边搅拌边加入上述3)步骤所得的提取液,基质与提取液的体积比为120:80,加热40分钟,再冷却至70℃,加入没药细粉和乳香细粉,搅匀,冷却至40℃,加入冰片细粉,搅匀,即成膏料;
8)、将膏料倒入膏药布的防渗圈内,防渗圈内的膏料为20g,即成膏药。
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