CN110279829B - 消肿止痛组合物在制备治疗痔疮药物中的用途 - Google Patents
消肿止痛组合物在制备治疗痔疮药物中的用途 Download PDFInfo
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Abstract
本发明涉及中药技术领域,提供消肿止痛组合物在制备治疗痔疮药物中的用途。消肿止痛组合物包括木香、防风、荆芥、细辛、五加皮、桂枝、牛膝、川芎、徐长卿、白芷、莪术、红杜仲、大罗伞、小罗伞、两面针、黄藤、栀子、三棱、沉香、樟脑、薄荷脑。本发明中药组合物中含有多种药物组分,作用靶点众多,对痔疮的治疗效果起到了标本兼治的效果,且该药配伍科学,疗效迅速,见效快、疗程短、治愈率高,且扩大了现有药物的适应症,为社会节约了大量的资源。
Description
技术领域
本发明涉及中药技术领域,具体涉及消肿止痛组合物在制备治疗痔疮药物中的用途。
背景技术
痔疮是人体直肠末端粘膜下和肛管皮肤下静脉丛发生扩张和屈曲所形成的柔软静脉团。多见于经常站立者和久坐者。痔疮包括内痔、外痔、混合痔,是肛门直肠底部及肛门粘膜的静脉丛发生曲张而形成的一个或多个柔软的静脉团的一种慢性疾病。通常当排便时持续用力,造成此处静脉内压力反复升高,静脉就会肿大。妇女在妊娠期,由于盆腔静脉受压迫,妨碍血液循环常会发生痔疮,许多肥胖的人也会罹患痔疮。如果患有痔疮,肛门内肿大扭曲的静脉壁就会变得很薄,因此排便时极易破裂。内痔是长在肛门管起始处的痔,如果膨胀的静脉位于更下方,几乎是在肛管口上,这种曲张的静脉就叫外痔。外痔有时会脱出或突现于肛管口外。但这种情形只有在排便时才会发生,排便后它又会缩回原来的位置。无论内痔还是外痔,都可能发生血栓。在发生血栓时,痔中的血液凝结成块,从而引起疼痛。痔疮给患者带来难以忍受的痛苦,严重者坐立不安,影响正常的工作和生活。
当前治疗这些疾病的方法有手术、套扎、注射、激光及药物内服外用等疗法,其不足是患者痛苦大,术后感染等。西药治疗镇痛效果好,但成本高,副作用大,不易根除。保守治疗的药物外用疗法中有马应龙麝香痔疮膏(栓)、九华痔疮栓、化痔栓、荣昌肛泰,然而配方不同,功效各异,尚不能满足临床需要。出血、搔痒、疼痛和脱出是痔疮的四种常见临床表现,同时痔疮也很容易引发肛肠疾病、贫血、妇科炎症、肛周湿疹、植物神经紊乱等其它系统性疾病,因此对痔疮进行及时的治疗,显得尤为重要。目前对痔疮的治疗方法主要包括手术疗法、药物内服疗法和药物外用疗法等,手术疗法在病后容易产生并发症,药物内服疗法疗效较慢,而目前市场上常见的痔疮外用药物疗效不够理想。
痔疮是慢性问题,而中医对于慢性问题的治疗早已闻名世界。和西医的手术治疗(易复发、痛苦、可能产生后遗症)相比较,中医对于痔疮此类慢性问题,以调理为主的治疗方式,效果十分理想。
消肿止痛酊为广西壮族自治区花红药业股份有限公司的独家产品,该品种收载于《中国药典》,产品包含二十一味中药原料,涉及到更多药材的提取。自目前尚未见消肿止痛酊组方在治疗痔疮方面的研究报道。
发明内容
本发明的目的是提供消肿止痛组合物在制备治疗痔疮药物中的用途。
所述组合物包括木香、防风、荆芥、细辛、五加皮、桂枝、牛膝、川芎、徐长卿、白芷、莪术、红杜仲、大罗伞、小罗伞、两面针、黄藤、栀子、三棱、沉香、樟脑、薄荷脑。
所述组合物包括木香10~50份,防风10~50份,荆芥10~50份,细辛10~50份,五加皮10~50份,桂枝10~50份,牛膝10~50份,川芎10~50份,徐长卿10~50份,白芷20~50份,莪术10~50份,红杜仲20~50份,大罗伞30~60份,小罗伞20~50份,两面针30~60份,黄藤25~60份,栀子30~60份,三棱20~50份,沉香5~60份,樟脑16~50份,薄荷脑16~50份
所述组合物进一步包括至少一种药学上可接受的辅料。
所述组合物的剂型为酊剂、巴布剂、涂膜剂、凝胶剂、气雾剂、喷雾剂、膏剂或糊剂。
所述组合物的制备方法包括以下制备步骤:
步骤1,按以下重量份称取原料:木香10~50份,防风10~50份,荆芥10~50份,细辛10~50份,五加皮10~50份桂枝10~50份,牛膝10~50份,川芎10~50份,徐长卿10~50份,白芷20~50份,莪术10~50份,红杜仲20~50份,大罗伞30~60份,小罗伞20~50份,两面针30~60份,黄藤25~60份,栀子30~60份,三棱20~50份,沉香5~60份,樟脑16~50份,薄荷脑16~50份;
步骤2,取木香、防风、川芎、三棱、沉香等5味药材,粗碎后,采用微米球磨机研磨2~3h,得粒径为100~200微米的药粉1;
步骤3,取荆芥、细辛、五加皮、桂枝、牛膝、徐长卿、白芷、莪术、大罗伞、小罗伞、红杜仲、两面针、黄藤、栀子等14味药材,粗碎后,采用微米球磨机研磨0.2~0.5h,得粒径为100~200微米的药粉2,与步骤2所得药粉1混合,真空冷冻干燥,得干燥粉;
步骤4,取纤维素酶液和步骤3所得干燥粉混合,真空负压浸渍0.5~1h小时,离心,收集上清液;
步骤5,利用陶瓷膜对步骤4所得上清液进行微滤,收集滤液;
步骤6,取樟脑、薄荷脑,加体积百分比为40~90%乙醇溶解,与步骤5所得滤液混匀,得消肿止痛中药组合物。
本发明通过临床试验验证了本发明药物组合物对痔疮患者的治疗效果,治疗结果显示(见表1):用本发明药物组合物治疗内痔患者52例,结果显效40例,总有效率为76.9%;外痔患者17例,显效11例,总有效率为94.1%;混合痔患者51例,显效38例,总有效率为96.1%。
可见,本发明药物组合物适合内痔、外痔和混合痔等各种类型痔疮的治疗。
总之,本发明中药组合物在痔疮方面,与现有技术相比具有如下优势:
1)与当前治疗的化学治疗药物相比,本发明中药组合物为天然纯中药制剂,不良反应和副作用显著降低,且本发明中药组合物作用全面,药物治疗效果更佳。
2)本发明中药组合物中含有多种药物组分,作用靶点众多,对痔疮的治疗效果起到了标本兼治的效果,且该药配伍科学,疗效迅速,见效快、疗程短、治愈率高、费用小的优点。
3)扩大了现有药物的适应症,为社会节约了大量的资源,因为新药研发需要使用大量的人力、物力、财力等大量资源。
4)为临床医生提供了新的治疗药物:老药新用。老药新用最大的优点是,不会产生新的不良反应,更加安全有效。
5)为患者提供经过科学试验确证的药物的新用途。
具体实施方式
下面以实施例作进一步说明,但本发明不局限于这些实施例。
实施例1
1.称取以下重量份的原料:木香22g,防风50g,荆芥30g,细辛15g,五加皮45g,桂枝18g,牛膝70g,川芎50g,徐长卿37g,白芷50g,莪术36g,红杜仲48g,大罗伞30g,小罗伞20g,两面针50g,黄藤35g,栀子30g,三棱50g,沉香9g,樟脑30g,薄荷脑50g。
2.取木香、防风、川芎、三棱、沉香等5味药材,粗碎后,采用微米球磨机研磨3h,得粒径小于200微米的药粉。
3.取荆芥、细辛、五加皮、桂枝、牛膝、徐长卿、白芷、莪术、大罗伞、小罗伞、红杜仲、两面针、黄藤、栀子等14味药材,粗碎后,采用微米球磨机研磨0.5h,得粒径小于200微米的药粉,与步骤2所得药粉混合,在温度-20℃、压力30Pa条件下真空冷冻干燥药粉2h,备用。
4.取纤维素酶液和步骤3所得药粉混合,真空浸渍1h,压力为0.6MPa,在转速3000rpm的条件下离心30min,收集上清液,其中,纤维素酶液由纤维素酶粉末加入于pH值5.5的醋酸-醋酸钠缓冲液中,调pH4.8,溶解定容而得。
5.利用陶瓷膜对步骤4所得的上清液进行微滤,收集滤液,所述微滤的工艺参数为:压力0.5MPa,流速2.5m/s,陶瓷膜过滤孔径为100nm。
6.取樟脑、薄荷脑,加200mL的90%乙醇溶解,与步骤5所得滤液混匀制得活性成分,活性成分以常规制剂手段制成外用涂剂。
以上提取时间总共为6.5小时。
实施例2
1.称取以下重量份的原料:木香10g,防风10g,荆芥10g,细辛10g,五加皮10g,桂枝10g,牛膝10g,川芎10g,徐长卿10g,白芷20g,莪术10g,红杜仲20g,大罗伞30g,小罗伞20g,两面针30g,黄藤25g,栀子30g,三棱20g,沉香5g,樟脑16g,薄荷脑16g。
2.取木香、防风、川芎、三棱、沉香等5味药材,粗碎后,采用微米球磨机研磨2h,得粒径小于100微米的药粉。
3.取荆芥、细辛、五加皮、桂枝、牛膝、徐长卿、白芷、莪术、大罗伞、小罗伞、红杜仲、两面针、黄藤、栀子等14味药材,粗碎后,采用微米球磨机研磨0.2h,粒径小于得粒径小于100微米的药粉,与步骤2所得药粉混合,在温度-10℃、压力10Pa条件下真空冷冻干燥药粉2h,备用。
4.取纤维素酶液和步骤3所得药粉混合,真空浸渍0.5h,压力为0.3MPa,在转速1000rpm的条件下离心30min,收集上清液,其中,纤维素酶液由纤维素酶粉末加入pH值为5.5的醋酸-醋酸钠缓冲液中,调pH至5.0,溶解定容而得。
5.利用陶瓷膜对步骤4所得的上清液进行微滤,收集滤液,所述微滤的工艺参数为:压力0.3MPa,流速1.5m/s,陶瓷膜过滤孔径为75nm。
6.取樟脑、薄荷脑,加50mL的40%乙醇溶解,与步骤5所得滤液混匀制得活性成分,活性成分以常规制剂手段制成外用膏剂。
以上提取时间总共为4.7小时。
实施例3
1.称取以下重量份的原料:木香50g,防风50g,荆芥50g,细辛50g,五加皮50g,桂枝50g,牛膝50g,川芎50g,徐长卿50g,白芷50g,莪术50g,红杜仲50g,大罗伞60g,小罗伞50g,两面针60g,黄藤60g,栀子60g,三棱50g,沉香60g,樟脑50g,薄荷脑50g。
2.取木香、防风、川芎、三棱、沉香等5味药材,粗碎后,采用微米球磨机研磨2.5h,粒径小于得粒径小于150微米的药粉。
3.取荆芥、细辛、五加皮、桂枝、牛膝、徐长卿、白芷、莪术、大罗伞、小罗伞、红杜仲、两面针、黄藤、栀子等14味药材,粗碎后,采用微米球磨机研磨0.3h,得粒径小于150微米的药粉,与步骤2所得药粉混合,在温度-15℃、压力20Pa条件下真空冷冻干燥药粉1.8h,备用。
4.取纤维素酶液和步骤3所得药粉混合,真空浸渍0.8h,压力为0.5MPa,在转速2000rpm的条件下离心30min,收集上清液,其中,纤维素酶液由纤维素酶粉末加入于pH值5.5的醋酸-醋酸钠缓冲液中,调pH5.5,溶解定容而得。
5.利用陶瓷膜对步骤4所得的上清液进行微滤,收集滤液,所述微滤的工艺参数为:压力0.4MPa,流速2.0m/s,陶瓷膜过滤孔径为60nm。
6.取樟脑、薄荷脑,加100mL的50%乙醇溶解,与步骤5所得滤液混匀制得活性成分,活性成分以常规制剂手段制成凝胶剂。
以上提取时间总共为5.4小时。
实施例4
1.称取以下重量份的原料:木香50g,防风40g,荆芥50g,细辛10g,五加皮50g,桂枝10g,牛膝50g,川芎50g,徐长卿50g,白芷45g,莪术20g,红杜仲20g,大罗伞30g,小罗伞35g,两面针60g,黄藤25g,栀子50g,三棱50g,沉香55g,樟脑26g,薄荷脑26g。
2.取木香、防风、川芎、三棱、沉香等5味药材,粗碎后,采用微米球磨机研磨3.0h,得粒径小于180微米的药粉。
3.取荆芥、细辛、五加皮、桂枝、牛膝、徐长卿、白芷、莪术、大罗伞、小罗伞、红杜仲、两面针、黄藤、栀子等14味药材,粗碎后,采用微米球磨机研磨0.5h,得粒径小于180微米的药粉,与步骤2所得药粉混合,在温度-15℃、压力20Pa条件下真空冷冻干燥药粉2.0h,备用。
4.取纤维素酶液和步骤3所得药粉混合,真空浸渍0.8h,压力为0.5MPa,在转速3000rpm的条件下离心30min,收集上清液,其中,纤维素酶液由纤维素酶粉末加入于pH值5.5的醋酸-醋酸钠缓冲液中,调pH6.0,溶解定容而得。
5.利用陶瓷膜对步骤4所得的上清液进行微滤,收集滤液,所述微滤的工艺参数为:压力0.4MPa,流速2.5m/s,陶瓷膜过滤孔径为50nm。
6.取樟脑、薄荷脑,加150mL的75%乙醇溶解,与步骤5所得滤液混匀制得活性成分,活性成分以常规制剂手段制成喷雾剂。
以上提取时间总共为6.3小时。
实施例5本发明临床实验例
1、一般资料
选择内痔、外痔、混合痔患者共120例,其中男79例,女41例,年龄22-65岁。平均年龄43.2岁。
2、诊断标准
痔疮临床分为内痔、外痔和混合痔,内痔病情较为严重。内痔的常见症状为出血、脱垂、肿胀、疼痛,分为4度。
I度:便时带血、滴血,便后出血可自行停止;无痔脱出。
Ⅱ度:常有便血;排便时有痔脱出,便后可自行还纳。
Ⅲ度:可有便血;排便或久站及咳嗽、劳累、负重时有痔脱出,需用手还纳。
Ⅳ度:可有便血;痔持续脱出或还纳后易脱出。
外痔平时无特殊症状,发生血栓及炎症可有肿胀、疼痛。
混合痔主要表现为内痔和外痔的症状同时存在。
3、治疗方法
口服本发明实施例1制备的外用制剂,每天2次,10天为一个疗程,连续治疗2个疗程。
4、疗效评定标准
显效:治疗后临床症状消失,体质恢复正常,观察半年无复发者;
好转:临床症状明显改善,体质逐步恢复;
无效:临床部分症状消失或无改变,达不到好转标准者。
5、治疗结果,参见表1
表1本发明药物组合物临床疗效数据
表1治疗结果显示:用本发明药物组合物治疗内痔患者52例,结果显效40例,总有效率为76.9%;外痔患者17例,显效11例,总有效率为94.1%;混合痔患者51例,显效38例,总有效率为96.1%。可见,本发明药物组合物适合内痔、外痔和混合痔等各种类型痔疮的治疗。
Claims (3)
1.消肿止痛组合物在制备治疗痔疮药物中的用途,所述组合物按重量份计由木香10~50份,防风10~50份,荆芥10~50份,细辛10~50份,五加皮10~50份,桂枝10~50份,牛膝10~50份,川芎10~50份,徐长卿10~50份,白芷20~50份,莪术10~50份,红杜仲20~50份,大罗伞30~60份,小罗伞20~50份,两面针30~60份,黄藤25~60份,栀子30~60份,三棱20~50份,沉香5~60份,樟脑16~50份,薄荷脑16~50份制成。
2.根据权利要求1所述的用途,其特征在于,所述组合物进一步加入至少一种药学上可接受的辅料。
3.根据权利要求1所述的用途,其特征在于,所述组合物的剂型为酊剂、巴布剂、涂膜剂、凝胶剂、气雾剂、喷雾剂、膏剂或糊剂。
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