CN104306894B - 一种治疗食管癌根治切除术并发乳糜胸的中药及其制备方法 - Google Patents
一种治疗食管癌根治切除术并发乳糜胸的中药及其制备方法 Download PDFInfo
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Abstract
本发明属于医药技术领域,具体涉及一种治疗食管癌根治切除术并发乳糜胸的中药及其制备方法。该中药由以下重量份的中药原料药制成:葶苈子11‑19份、桑白皮11‑19份、姜黄6‑14份、瓜蒌皮8‑16份、柴胡6‑14份、白芥子6‑14份、枳壳6‑14份、大枣6‑14份、金银花8‑16份、黄芩6‑14份、麦冬6‑14份、沙参6‑14份、地骨皮6‑14份、甘草2‑10份。该药物具有泻肺逐饮,理气活血,祛痰通络的功效。临床用于治疗食管癌根治切除术并发乳糜胸,总有效率94.6%,治愈率83.78%。
Description
技术领域
本发明属于医药技术领域,具体涉及一种治疗食管癌根治切除术并发乳糜胸的中药及其制备方法。
背景技术
食管癌术后乳糜胸的出现是一种严重的并发症, 国内报道其发生率约为0.4%~2.6%。乳糜胸是食管癌切除术后严重的并发症之一, 大量体液、电解质及营养物质丢失会导致患者营养状况迅速恶化, 最终衰竭死亡。主要原因是损伤胸导管或其属支, 但术中未能及时发现或没能得到适当的处理, 从而术后出现乳糜液的漏出, 导致乳糜胸。近年来,随着食管癌根治术的广泛应用及较多的临床分期较晚患者得以进行食管癌根治术, 肿瘤与周围组织粘连严重的患者数量明显增多, 使手术中胸导管及其属支损伤的机会增大。手术治疗是治疗糜胸的主要方法之一, 长期以来手术时机的掌握始终存在争议, 有报道认为胸腔乳糜液引流量超过1200mL/ d 持续1 周无停止迹象, 可行手术治疗。因为大量电解质、蛋白及脂肪等成份的丢失, 可迅速导致严重的代谢紊乱及机体衰竭, 容易失去最佳手术时机, 导致二次手术后死亡率的增长。因此,需要寻找治疗乳糜胸的药物,药物不需要判断手术时机,发现乳糜胸即可使用。
目前,尚未有专用于治疗食管癌根治切除术并发乳糜胸的药物。
发明内容
本发明所要解决的技术问题是避免上述现有技术所存在的不足之处,提供一种治疗食管癌根治切除术并发乳糜胸的中药,该药物具有泻肺逐饮,理气活血,祛痰通络的功效。
本发明所要解决的另一技术问题是提供该中药组合物的剂型及其制备方法。
本发明是通过如下技术方案实现的:
一种治疗食管癌根治切除术并发乳糜胸的中药,由以下重量份的中药原料药制成:
葶苈子11-19份、桑白皮11-19份、姜黄6-14份、瓜蒌皮8-16份、柴胡6-14份、白芥子6-14份、枳壳6-14份、大枣6-14份、金银花8-16份、黄芩6-14份、麦冬6-14份、沙参6-14份、地骨皮6-14份、甘草2-10份。
优选的,上述的治疗食管癌根治切除术并发乳糜胸的中药,由以下重量份的中药原料药制成:
葶苈子13-17份、桑白皮13-17份、姜黄8-12份、瓜蒌皮10-14份、柴胡8-12份、白芥子8-12份、枳壳8-12份、大枣8-12份、金银花10-14份、黄芩8-12份、麦冬8-12份、沙参8-12份、地骨皮8-12份、甘草4-8份。
更优选的,上述的治疗食管癌根治切除术并发乳糜胸的中药,由以下重量份的中药原料药制成:
葶苈子15份、桑白皮15份、姜黄10份、瓜蒌皮12份、柴胡10份、白芥子10份、枳壳10份、大枣10份、金银花12份、黄芩10份、麦冬10份、沙参10份、地骨皮10份、甘草6份。
上述的治疗食管癌根治切除术并发乳糜胸的中药,该中药组合物的剂型形式为口服制剂。优选为颗粒剂。
上述的治疗治疗食管癌根治切除术并发乳糜胸的中药的制备方法,包含如下步骤:
(a)将葶苈子、桑白皮、姜黄、大枣、黄芩、麦冬、沙参、地骨皮、甘草9味药材加上述药材8~12倍重量的水煎煮2次,每次煎煮0.5~1.5小时,合并两次的煎出液,于60℃下减压浓缩至原煎出液体积的一半,倾出放凉,冷藏12小时,滤过,滤液60℃减压浓缩至相对密度为1.25~1.28的清膏;
(b)将瓜蒌皮、柴胡、白芥子、枳壳、金银花用药材体积3~5倍量的75%乙醇浸泡10~14小时后回流提取2次,每次1小时,过滤,合并滤液,滤液在0.05~0.07MPa下减压回收乙醇至药液无醇味儿,60℃减压浓缩至相对密度为1.20~1.25的清膏;
(c)合并两部分清膏,混匀,减压干燥,粉碎,过100目筛,制备成浸膏粉,加入药学上可接受的辅料,混匀,以75%乙醇作润湿剂制粒,干燥,整粒,即得。
优选的,上述的治疗食管癌根治切除术并发乳糜胸的中药的制备方法,所述步骤(1)中加水量为药材10倍重量,每次煎煮1小时。
优选的,上述的治疗食管癌根治切除术并发乳糜胸的中药的制备方法,所述步骤(2)中加75%乙醇量为药材4倍体积,每次煎煮12小时。
上述的治疗食管癌根治切除术并发乳糜胸的中药的制备方法,详细步骤如下:
(a)将葶苈子、桑白皮、姜黄、大枣、黄芩、麦冬、沙参、地骨皮、甘草9味药材加上述药材10倍重量的水煎煮2次,每次煎煮1小时,合并两次的煎出液,于60℃下减压浓缩至原煎出液体积的一半,倾出放凉,冷藏12小时,滤过,滤液60℃减压浓缩至相对密度为1.25~1.28的清膏;
(b)将瓜蒌皮、柴胡、白芥子、枳壳、金银花用药材体积4倍量的75%乙醇浸泡12小时后回流提取2次,每次1小时,过滤,合并滤液,滤液在0.05~0.07MPa下减压回收乙醇至药液无醇味儿,60℃减压浓缩至相对密度为1.20~1.25的清膏;
(c)合并两部分清膏,混匀,减压干燥,粉碎,过100目筛,制备成浸膏粉,加入药学上可接受的辅料,混匀,以75%乙醇作润湿剂制粒,干燥,整粒,即得。
所述的药学上可接受的辅料选自:蔗糖、淀粉、硬脂酸镁、甘露醇、山梨醇、山梨酸或钾盐、焦亚硫酸钠、亚硫酸氢钠、硫代硫酸钠、盐酸半胱氨酸、巯基乙酸、蛋氨酸、维生素A、维生素C、维主素E、维生素D、氮酮、EDTA二钠、EDTA钙钠,一价碱金属的碳酸盐、醋酸盐、磷酸盐或其水溶液、盐酸、醋酸、硫酸、磷酸、氨基酸、氯化钠、氯化钾、乳酸钠、木糖醇、麦芽糖、葡萄糖、果糖、右旋糖苷、甘氨酸、乳糖、甘露糖醇、硅衍生物、纤维素及其衍生物、藻酸盐、明胶、聚乙烯吡咯烷酮、甘油、丙二醇、乙醇、吐温60~80、司班~80、蜂蜡、羊毛脂、液体石蜡、十六醇、没食子酸酯类、琼、三乙醇胺、碱性氨基酸、尿素、尿囊素、碳酸钙、碳酸氢钙、表面活性剂、聚乙二醇、环糊精、β~环糊精、磷脂类材料、高岭土、滑石粉、硬脂酸钙等。
本发明的的治疗食管癌根治切除术并发乳糜胸的中药具有泻肺逐饮,理气活血,祛痰通络的功效,临床用于治疗食管癌根治切除术并发乳糜胸。
乳糜胸属中医悬饮范畴。治以泻肺逐饮为法。本发明的中药中,葶苈子、桑白皮泻肺逐饮,金银花、黄芩清泄肺热,麦冬、沙参、地骨皮滋阴清热,姜黄、丹参、桃仁理气活血,和络消饮,栝萎皮、枳壳理气化饮,柴胡清热和解,白芥子祛痰通络,大枣缓和药性,甘草调和诸药,诸药共凑泻肺逐饮,理气活血,祛痰通络之功,使胸胁气机升降调畅,络气和利,饮邪得除。
具体实施方式
下面结合具体实施例对本发明作更进一步的说明,以便本领域的技术人员更了解本发明,但并不因此限制本发明。
实施例1:本发明中药组合物颗粒剂的制备
处方:葶苈子150g、桑白皮150g、姜黄100g、瓜蒌皮120g,柴胡100g、白芥子100g、枳壳100g、大枣100g、金银花120g、黄芩100g、麦冬100g、沙参100g、地骨皮100g、甘草60g。
制备方法:
(a)将葶苈子、桑白皮、姜黄、大枣、黄芩、麦冬、沙参、地骨皮、甘草9味药材加上述药材10倍重量的水煎煮2次,每次煎煮1小时,合并两次的煎出液,于60℃下减压浓缩至原煎出液体积的一半,倾出放凉,冷藏12小时,滤过,滤液60℃减压浓缩至相对密度为1.25~1.28的清膏;
(b)将瓜蒌皮、柴胡、白芥子、枳壳、金银花用药材体积4倍量的75%乙醇浸泡12小时后回流提取2次,每次1小时,过滤,合并滤液,滤液在0.05~0.07MPa下减压回收乙醇至药液无醇味儿,60℃减压浓缩至相对密度为1.20~1.25的清膏;
(c)合并两部分清膏,混匀,减压干燥,粉碎,过100目筛,制备成浸膏粉,加入蔗糖,混匀,以75%乙醇作润湿剂制粒,干燥,整粒,即得本发明中药的颗粒剂。
共制备1000g,产品进行质量检验,检验合格后包装消毒。每袋重10g,每日服三次,每次1袋。
实施例2:本发明中药组合物颗粒剂的制备
处方:葶苈子130g、桑白皮170g、姜黄80g、瓜蒌皮140g、柴胡80g、白芥子120g、枳壳80g、大枣120g、金银花100g、黄芩120g、麦冬80g、沙参120g、地骨皮80g、甘草80g。
制备方法:
(a)将葶苈子、桑白皮、姜黄、大枣、黄芩、麦冬、沙参、地骨皮、甘草9味药材加上述药材10倍重量的水煎煮2次,每次煎煮1小时,合并两次的煎出液,于60℃下减压浓缩至原煎出液体积的一半,倾出放凉,冷藏12小时,滤过,滤液60℃减压浓缩至相对密度为1.25~1.28的清膏;
(b)将瓜蒌皮、柴胡、白芥子、枳壳、金银花用药材体积4倍量的75%乙醇浸泡12小时后回流提取2次,每次1小时,过滤,合并滤液,滤液在0.05~0.07MPa下减压回收乙醇至药液无醇味儿,60℃减压浓缩至相对密度为1.20~1.25的清膏;
(c)合并两部分清膏,混匀,减压干燥,粉碎,过100目筛,制备成浸膏粉,加入蔗糖,混匀,以75%乙醇作润湿剂制粒,干燥,整粒,即得本发明中药的颗粒剂。
共制备1000g,产品进行质量检验,检验合格后包装消毒。每袋重10g,每日服三次,每次1袋。
实施例3:本发明中药组合物颗粒剂的制备
处方:葶苈子170g、桑白皮130g、姜黄120g、瓜蒌皮100g、柴胡120g、白芥子80g、枳壳120g、大枣80g、金银花140g、黄芩80g、麦冬120g、沙参80g、地骨皮120g、甘草40g。
制备方法:
(a)将葶苈子、桑白皮、姜黄、大枣、黄芩、麦冬、沙参、地骨皮、甘草9味药材加上述药材10倍重量的水煎煮2次,每次煎煮1小时,合并两次的煎出液,于60℃下减压浓缩至原煎出液体积的一半,倾出放凉,冷藏12小时,滤过,滤液60℃减压浓缩至相对密度为1.25~1.28的清膏;
(b)将瓜蒌皮、柴胡、白芥子、枳壳、金银花用药材体积4倍量的75%乙醇浸泡12小时后回流提取2次,每次1小时,过滤,合并滤液,滤液在0.05~0.07MPa下减压回收乙醇至药液无醇味儿,60℃减压浓缩至相对密度为1.20~1.25的清膏;
(c)合并两部分清膏,混匀,减压干燥,粉碎,过100目筛,制备成浸膏粉,加入蔗糖,混匀,以75%乙醇作润湿剂制粒,干燥,整粒,即得本发明中药的颗粒剂。
共制备1000g,产品进行质量检验,检验合格后包装消毒。每袋重10g,每日服三次,每次1袋。
实施例4:本发明中药组合物颗粒剂的制备
处方:葶苈子110g、桑白皮190g、姜黄60g、瓜蒌皮160g、柴胡60g、白芥子140g、枳壳60g、大枣140g、金银花80g、黄芩140g、麦冬60g、沙参140g、地骨皮60g、甘草100g。
制备方法同实施例1。
共制备1000g,产品进行质量检验,检验合格后包装消毒。每袋重10g,每日服三次,每次1袋。
实施例5:本发明中药组合物颗粒剂的制备
处方:葶苈子190g、桑白皮110g、姜黄140g、瓜蒌皮80g、柴胡140g、白芥子60g、枳壳140g、大枣60g、金银花160g、黄芩60g、麦冬140g、沙参60g、地骨皮140g、甘草20g。
制备方法同实施例1。
共制备1000g,产品进行质量检验,检验合格后包装消毒。每袋重10g,每日服三次,每次1袋。
对本发明实施例1制备的颗粒剂进行了临床试验,详情如下:
1 临床资料
1.1 一般资料
本组患者37例,男23例,女14例;年龄38.2~80.3岁,平均58.3岁。上段食管癌11例,中段食管癌10例,下段食管癌16例。全组病例均有吞咽梗阻感并经食道镜或纤维胃镜取病理活检确诊为食管癌,病变长度3.2~13.5cm,平均5.3cm。病理形态:髓样型25例,缩窄型7例,溃疡型5例。组织学特点:30例鳞状细胞癌,7例腺癌。临床病理分期:Ⅰ期2例,Ⅱ期8例,Ⅲ期27例。37例中行左侧剖胸手术31例,右侧剖胸手术6例;19例行食管-胃颈部吻合,15例行食管-胃弓上吻合,3例行食管-胃弓下吻合,术中均见病变与邻近组织有不同程度粘连。
1.2 乳糜液情况
乳糜胸发生时间为术后1~14d,平均为术后4.9d。其中左侧30例,占81.1%,右侧6例,占16.2%;双侧1例,占2.7%。出现下列情况高度怀疑乳糜胸:(1)胸腔闭式引流瓶中发现有不凝固的“牛乳”状液体;(2)引流液中含有微小的游离脂肪滴,脂肪含量高于血浆;(3)引流液涂片在显微镜下进行检查,可见清亮脂肪滴;(4)涂片苏丹Ⅲ染色后显微镜下观察,有脂肪滴;(5)乳糜液5mL装入试管内加少许乙醚进行震荡,乳白色“牛乳”状颜色消失,转为澄清。引流量500~2000mL/d,平均1250mL,颜色分别为淡红、淡黄或乳白色。本组出现呼吸困难、胸廓饱满症状者28例,占75.7%,心率快、心慌气促者7例,占18.9%,血压下降、电解质紊乱、脱水2例,占5.4%。
1.3 治疗方法
非手术治疗笔者采用:(1)保持胸腔闭式引流的通畅,以利于胸腔液的观察、排出,保护呼吸功能;(2)维持水电解质平衡,给予支持治疗,如输血、白蛋白、血浆等促进肌体合成代谢;(3)能进食的患者给予高蛋白、高热量、低脂肪饮食;(4给予本发明实施例制备的中药颗粒,每次1袋,每日3次,饭后服用。7天为1个疗程。
1.4 疗效判定标准
治愈:乳糜胸消失,胸腔闭式引流瓶中不再有有不凝固的“牛乳”状液体。
有效:胸腔闭式引流瓶中不凝固的“牛乳”状液体减少50%以上。
无效:未见症状改善。
1.5 结果
37例患者中,治愈31例,有效4例,无效2例,无效的2例2例死于水电解质紊乱和全身衰竭。总有效率94.6%,治愈率83.78%。
Claims (6)
1.一种治疗食管癌根治切除术并发乳糜胸的中药,由以下重量份的中药原料药制成:
葶苈子11-19份、桑白皮11-19份、姜黄6-14份、瓜蒌皮8-16份、柴胡6-14份、白芥子6-14份、枳壳6-14份、大枣6-14份、金银花8-16份、黄芩6-14份、麦冬6-14份、沙参6-14份、地骨皮6-14份、甘草2-10份;
其中,上述治疗治疗食管癌根治切除术并发乳糜胸的中药的制备方法,包含如下步骤:
(a)将葶苈子、桑白皮、姜黄、大枣、黄芩、麦冬、沙参、地骨皮、甘草9味药材加上述药材8~12倍重量的水煎煮2次,每次煎煮0.5~1.5小时,合并两次的煎出液,于60℃下减压浓缩至原煎出液体积的一半,倾出放凉,冷藏12小时,滤过,滤液60℃减压浓缩至相对密度为1.25~1.28的清膏;
(b)将瓜蒌皮、柴胡、白芥子、枳壳、金银花用药材体积3~5倍量的75%乙醇浸泡10~14小时后回流提取2次,每次1小时,过滤,合并滤液,滤液在0.05~0.07MPa下减压回收乙醇至药液无醇味儿,60℃减压浓缩至相对密度为1.20~1.25的清膏;
(c)合并两部分清膏,混匀,减压干燥,粉碎,过100目筛,制备成浸膏粉,加入药学上可接受的辅料,混匀,以75%乙醇作润湿剂制粒,干燥,整粒,即得。
2.根据权利要求1所述的治疗食管癌根治切除术并发乳糜胸的中药,其特征在于,由以下重量份的中药原料药制成:
葶苈子13-17份、桑白皮13-17份、姜黄8-12份、瓜蒌皮10-14份、柴胡8-12份、白芥子8-12份、枳壳8-12份、大枣8-12份、金银花10-14份、黄芩8-12份、麦冬8-12份、沙参8-12份、地骨皮8-12份、甘草4-8份。
3.根据权利要求2所述的治疗食管癌根治切除术并发乳糜胸的中药,其特征在于,由以下重量份的中药原料药制成:
葶苈子15份、桑白皮15份、姜黄10份、瓜蒌皮12份、柴胡10份、白芥子10份、枳壳10份、大枣10份、金银花12份、黄芩10份、麦冬10份、沙参10份、地骨皮10份、甘草6份。
4.根据权利要求1所述的治疗食管癌根治切除术并发乳糜胸的中药,其特征在于,所述步骤(a)中加水量为药材10倍重量,每次煎煮1小时。
5.根据权利要求1所述的治疗食管癌根治切除术并发乳糜胸的中药,其特征在于,所述步骤(b)中加75%乙醇量为药材4倍体积,浸泡12小时后回流提取2次。
6.一种如权利要求1所述的治疗食管癌根治切除术并发乳糜胸的中药的制备方法,详细步骤如下:
(a)将葶苈子、桑白皮、姜黄、大枣、黄芩、麦冬、沙参、地骨皮、甘草9味药材加上述药材10倍重量的水煎煮2次,每次煎煮1小时,合并两次的煎出液,于60℃下减压浓缩至原煎出液体积的一半,倾出放凉,冷藏12小时,滤过,滤液60℃减压浓缩至相对密度为1.25~1.28的清膏;
(b)将瓜蒌皮、柴胡、白芥子、枳壳、金银花用药材体积4倍量的75%乙醇浸泡12小时后回流提取2次,每次1小时,过滤,合并滤液,滤液在0.05~0.07MPa下减压回收乙醇至药液无醇味儿,60℃减压浓缩至相对密度为1.20~1.25的清膏;
(c)合并两部分清膏,混匀,减压干燥,粉碎,过100目筛,制备成浸膏粉,加入药学上可接受的辅料,混匀,以75%乙醇作润湿剂制粒,干燥,整粒,即得。
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