CN117338893A - 一种散结的药物组合物及其制剂和应用 - Google Patents
一种散结的药物组合物及其制剂和应用 Download PDFInfo
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Abstract
本发明公开一种散结的药物组合物,由夏枯草、土贝母、透骨草、重楼、山慈菇、莪术、川芎、郁金、牡蛎、鹿角霜组成。所述散结的药物组合物添加药学上可接受的辅料,制成制剂。所述散结的药物组合物及其制剂可用于制备活血化瘀、消肿散结的药物。
Description
技术领域
本发明属于药物领域,具体涉及一种散结的药物组合物及其制剂和应用。
背景技术
良性结节及良性包块是临床上常见的体征,且发病率随着年龄增长而增长,主要包括甲状腺肿、子宫肌瘤、卵巢囊肿、宫外孕包块、前列腺增生、慢性淋巴结炎、脂肪瘤等。大部分良性结节早期没有明显的症状,大多数患者是在体检时经超声检查发现的,少数患者是自己触摸到结节、或行动时有异物感而进行超声检查确诊的。西医主要以随访观察为主,少数采取其他处理手段,且多为有创性治疗手段,缺乏非毁伤性治疗手段,存在复发风险大、适用范围局限、费用昂贵、易造成心理创伤等诸多不足。中医药具有整体调节、方法多样、多靶点用药、不良反应少等优势,患者的医从性及治疗意愿强,因此,研发一种副作用小的散结药物用于治疗各类结节是非常有必要的。
发明内容
针对现有技术存在的不足,本发明的目的在于提供一种散结的药物组合物及其制剂。本发明所述的药物组合物具有活血化瘀、消肿散结的功效,可用于治疗各种良性结节及包块,如甲状腺结节、乳腺结节、皮下结节、肺结节等。
本发明的目的是通过以下技术方案实现的:
一种散结的药物组合物,按重量份数计,由如下组分组成:夏枯草20-50份、土贝母20-50份、透骨草20-50份、重楼10-30份、山慈菇10-30份、莪术20-50份、川芎20-50份、郁金20-50份、牡蛎20-50份、鹿角霜20-50份。
优选地,所述散结的药物组合物,按重量份数计,由如下组分组成:夏枯草25-40份、土贝母25-40份、透骨草25-40份、重楼13-20份、山慈菇13-20份、莪术25-40份、川芎25-40份、郁金25-40份、牡蛎25-40份、鹿角霜25-40份。
更优选地,所述散结的药物组合物,按重量份数计,由如下组分组成:夏枯草28-35份、土贝母28-35份、透骨草28-35份、重楼15-17份、山慈菇15-17份、莪术28-35份、川芎28-35份、郁金28-35份、牡蛎28-35份、鹿角霜28-35份。
方中,夏枯草、土贝母、透骨草为君药,夏枯草清热化痰、解毒散结调痰郁、火郁之态;土贝母消癥散结,透骨草散瘀消肿,三药均有散结消癥之功,其中夏枯草、透骨草入肝经,土贝母入肺经,肝主疏泄,肺主治节,三药合用,肝肺同治,散结之力更甚;重楼、山慈菇可清热解毒、消瘀止痛、消痞散结,莪术、川芎、郁金有活血化瘀、行气散结之功,牡蛎软坚散结作用较强,可散结止痛,六味药合用使气得以顺,血得以行,气血通畅,共为臣药,配合君药则癥得以消,结得以散,散结不留瘀;配以佐药鹿角霜以温肾助阳,一以助长肾气、达生血之功,二佐制散结药之寒凉,诸药配伍,共奏行气活血、散结消肿之效。全方以行气化痰消瘿为基本治则,内服、外用治疗结节效果均甚佳。
所述散结的药物组合物,可以添加药学上可接受的辅料,制成凝胶贴膏、贴膏等制剂。
所述散结的药物组合物及其制剂,可用于制备行气活血、散结消肿的药物。
与现有技术相比,本发明具有的有益效果:
1、本发明所述散结的药物组合物及其制剂,适用于人身体各种良性包块和结节,能有效的对身体经络进行疏通,减小人体包块的大小,有助于身体机能恢复。
2、本发明所述散结的药物组合物的外用贴剂,外用无纺布包裹,贴敷方便,不易污染衣物,且安全有效,无毒副作用。
具体实施方式
下面结合实施例对本发明作进一步说明,但本发明并不局限于实施例。
实施例1
一种散结的药物组合物,由如下组分组成:夏枯草20g、土贝母20g、透骨草20g、重楼10g、山慈菇10g、莪术20g、川芎20g、郁金20g、牡蛎20g、鹿角霜20g。
实施例2
一种散结的药物组合物,由如下组分组成:夏枯草50g、土贝母50g、透骨草50g、重楼30g、山慈菇30g、莪术50g、川芎50g、郁金50g、牡蛎50g、鹿角霜50g。
实施例3
一种散结的药物组合物,由如下组分组成:夏枯草50g、土贝母20g、透骨草50g、重楼10g、山慈菇30g、莪术20g、川芎20g、郁金50g、牡蛎20g、鹿角霜50g。
实施例4
一种散结的药物组合物,由如下组分组成:夏枯草20g、土贝母50g、透骨草20g、重楼30g、山慈菇10g、莪术50g、川芎50g、郁金20g、牡蛎50g、鹿角霜20g。
实施例5
一种散结的药物组合物,由如下组分组成:夏枯草30g、土贝母30g、透骨草30g、重楼15g、山慈菇15g、莪术30g、川芎30g、郁金30g、牡蛎30g、鹿角霜30g。
实施例6
一种散结的药物组合物,由如下组分组成:夏枯草25g、土贝母28g、透骨草25g、重楼15g、山慈菇13g、莪术35g、川芎35g、郁金25g、牡蛎35g、鹿角霜28g。
实施例7
一种散结的药物组合物,由如下组分组成:夏枯草28g、土贝母35g、透骨草40g、重楼17g、山慈菇20g、莪术28g、川芎40g、郁金28g、牡蛎40g、鹿角霜25g。
实施例8
一种散结的药物组合物,由如下组分组成:夏枯草35g、土贝母40g、透骨草28g、重楼13g、山慈菇15g、莪术40g、川芎28g、郁金35g、牡蛎25g、鹿角霜40g。
实施例9
一种散结的药物组合物,由如下组分组成:夏枯草40g、土贝母25g、透骨草35g、重楼20g、山慈菇17g、莪术25g、川芎25g、郁金40g、牡蛎28g、鹿角霜35g。
实施例10
一种散结的药物组合物的凝胶贴膏剂,按照实施例1-9任意一项所述的药物组合物的重量称取药材,按以下步骤制备:
S1:将EDTA、甘羟铝、聚丙烯酸钠加入甘油中,在反应釜内搅拌均匀,为A相;
S2:将EM-178、AC-10H、促渗剂、防腐剂和加工后的药物组合物加入水中,搅拌混合后,为B相;
S3:将酒石酸加入水中,超声分散,为C相;
S4:将A相、B相、C相混合,真空搅拌均匀,涂布在背衬层,再盖上防粘膜,即得。
制得的凝胶贴膏剂包括背衬层、膏体层和防粘膜,所述膏体层为A相+B相+C相共同形成的凝胶层;所述背衬层为无纺布;所述防粘膜为黏胶面涂胶的压纹膜。载药量为10~25wt%。
优选地,甘油:EDTA:甘羟铝:聚丙烯酸钠:水:药物组合物:EM-178:AC-10H:促渗剂:防腐剂:酒石酸=(250~400g):(0.5~1.5g):(1.0~3.0g):(40~60g):(200~300g):150g:(100~200g):(50~200g):(20~40g):(0.5~2g):(2~4g)。
优选地,步骤S2中,EM-178:AC-10H:促渗剂:防腐剂:药物组合物:水=(100~200g):(50~200g):(20~40g):(0.5~2g):150g:(150~200g)。
优选地,步骤S2中,所述促渗剂为薄荷脑、樟脑、冰片或氮酮中的任意一种或两种以上的混合物。
优选地,步骤S2中,所述加工后的药物组合物为本发明所述药物组合物的水提物、醇提物、挥发油、混合药膏制剂或药粉。
优选地,步骤S3中,酒石酸:水=(2~4g):(50~100g)。
应用实施例1——本发明所述的散结的药物组合物凝胶贴膏剂外敷治疗良性甲状腺结节的临床疗效
1资料与方法
1.1一般资料
选取2021年9月-2022年5月于某省中医医院内分泌科就诊的良性甲状腺结节患者70例,按随机数表法分成治疗组及对照组,每组35例。治疗组男性7例,女性28例,年龄21-71岁,平均年龄(48.46±13.50)岁,最大结节体积0.021-9.158cm3;对照组男性4例,女性31例,年龄32-74岁,平均年龄(49.71±12.31)岁,最大结节体积0.025-9.012cm3。两组研究对象在性别、年龄、最大结节体积、中医证候积分上比较差异无统计学意义(P>0.05),具有可比性,见表1、表2。
1.2诊断标准
参照2012版《甲状腺结节和分化型甲状腺癌诊治指南》,标准如下:①影像学检查:超声检查提示结节数量≥1个,除外压迫周围器官及恶性肿瘤可能;②症状:结节可随吞咽上下活动,无红肿热痛;③体征:甲状腺查体可触及1个及以上结节,边界清楚,随吞咽上下活动,无压痛、震颤及血管杂音;④实验室检查:甲状腺功能及自身抗体无异常。
1.3纳入标准
①符合上述诊断标准,超声证实为结节且符合2012年《甲状腺结节和分化型甲状腺癌诊治指南》甲状腺良性结节筛选标准;若超声提示恶性征象,则完善超声引导下细针穿刺活检;②年龄20-75周岁;③获得知情同意书,自愿接受入组治疗,并提供追踪观察。
1.4排除标准
①Graves病、甲状腺功能减退、甲状腺炎等甲状腺功能异常;②甲状腺癌和转移性甲状腺癌;③精神疾病,妊娠或哺乳期,过敏体质及对本药过敏;④合并肝肾功能障碍及严重创伤或重大手术后。
1.5剔除标准
①不能耐受试验药物;②依从性差,未按规定用药及访视;③治疗期间接受其他治疗方案;④受试者妊娠。
1.6治疗方法
对照组予基础治疗,即健康教育,包括合理的饮食习惯、适度的运动、保持心情舒畅。治疗组在此基础上加用本发明所述散结的药物组合物的贴剂(采用实施例8所述药物组合物按照实施例10所述方法制备)外敷于颈部甲状腺处皮肤,每日更换1次,每天持续6~8h,两组均治疗12周。
1.7观察指标
1.7.1最大结节体积及疗效评定
运用超声测量治疗前后最大结节长、宽、高,记录并计算体积。体积计算公式=长×宽×高×π/6,体积缩小率=[(治疗前结节体积-治疗后结节体积)]×100%/治疗前结节体积。根据治疗后甲状腺结节缩小程度将临床疗效分为无效、有效、显效、痊愈。结节消失,临床症状完全消失为痊愈;结节体积缩小≥50%,临床症状明显改善为显效;结节体积缩小≥30%且<50%,临床症状有所减轻为有效;结节体积缩小<30%或出现增大趋势,临床症状无明显好转甚至有加重迹象为无效。总有效率=(痊愈+显效+有效)/总例数×100%。
1.7.2中医证候积分及疗效评定
采用中医证候积分表(参考2002年《中药新药临床研究指导原则》及临床实际情况制定),包括颈部触及结节、颈前胀满、喉间有痰、胸闷不适、纳差等,各项分值0~6分,分值越高症状越重。记录中医临床症状及体征,分别于治疗前及治疗后进行评分。疗效指数=[(治疗前积分-治疗后积分)/治疗前积分]×100%。证候积分下降≥95%为临床痊愈;70%≤下降<95%为显效;30%≤下降<70%为有效;下降<30%为无效。总有效率=(痊愈+显效+有效)/总例数×100%。
1.8统计学方法
采用SPSS26.0统计学进行数据处理分析,计量资料用()表示;计数资料采用卡方检验或秩和检验。P<0.05为差异有统计学意义。
2结果
2.1最大结节体积及疗效比较
2.1.1两组治疗前后最大结节体积比较,治疗组治疗前后最大结节体积明显减小,差异有统计学意义(P<0.05);对照组治疗前后最大结节体积未明显减小,差异无统计学意义(P>0.05),见表3。
2.1.2两组疗效比较,治疗组显著高于对照组,差异有统计学意义(P<0.05),见表4。
2.2 中医证候积分及疗效评定
2.2.1 两组治疗前后中医证候积分比较,治疗组治疗前后中医症候明显改善,差异有统计学意义(P<0.05);对照组治疗前后中医症候无明显改善,差异无统计学意义(P>0.05),见表5。
2.2.2两组疗效比较,治疗组显著优于对照组,差异有统计学意义(P<0.05),见表6。
3分析
结果显示,治疗组治疗前后最大结节体积、中医证候积分比较差异有统计学意义,治疗组疗效显著优于对照组。综上,本发明所述的散结的药物组合物凝胶贴膏剂外敷可缩小甲状腺结节,明显改善中医临床症状,为临床提供一种便捷、有效的治疗方法。
应用实施例2——本发明所述的散结的药物组合物凝胶贴膏剂外敷治疗良性乳腺结节的临床疗效
1资料与方法
1.1一般资料
选择2023年3月至2023年8月某省中医医院收治的157例乳腺结节患者,采用随机数字表法分为对照组85例和观察组72例。对照组患者年龄23-51岁,平均(35.43±7.58)岁;病程5个月-11年,平均(3.62±1.69)年。对照组患者年龄23-52岁,平均(35.68±7.51)岁;病程4个月-10年,平均(3.41±1.58)年。两组患者一般资料经比较,差异无统计学意义(P>0.05),组间可比,见表7。
1.2诊断标准
西医诊断标准:参考《妇产科学》中关于乳腺结节的诊断标准,①症状和体征,单侧/双侧乳房均存在程度不同的胀痛、隐痛、刺痛,疼痛持续90天或断续3-6个月未缓解;②经B超检查发现乳腺结构紊乱,有增多的反射波。
1.3纳入标准
符合上述中西医诊断标准者;4周内未应用治疗乳腺结节疾病的任何药物,半年内未实施激素类制剂者;无精神问题者;无严重性心脏、肝、肾功能障碍者等。
1.4排除标准
功能性出血者;妊娠期/哺乳期女性;对本研究药物过敏者;乳房恶性肿瘤者;凝血功能、免疫功能低下者等。研究已经院内医学伦理委员会批准,患者及其家属均签署知情同意书。
1.5治疗方法
对照组采用模拟剂,于乳腺结节处外涂模拟剂,制备的模拟剂要求规格、外观、性状、气味与实施例10所述方法制备的制剂基本一致,不含药物。治疗组采用本发明所述散结的药物组合物的贴剂(采用实施例5所述药物组合物按照实施例10所述方法制备)外敷于乳腺结节处皮肤,每日更换1次,每天持续6~8h,两组均治疗12周。
1.6观察指标
①比较两组患者治疗效果。痊愈:患者肿块消失,乳房胀痛感和刺痛反应消失,停药后无复发,内分泌水平基本稳定;改善:乳房刺痛和肿痛反应缓解,肿块直径明显缩小,内分泌水平相比于治疗前有所改善;无效:乳房刺痛和肿痛反应无任何改善,肿块无缩小,内分泌水平未改善。总有效率=(痊愈+改善)/总例数。
②比较两组患者肿块状态。肿块硬度1级:质软,相比于正常腺体较硬记3分;2级:质韧和鼻尖相近,记6分;3级:质地坚硬如额头记9分。肿块范围(1个乳房象限记录1.5分),1级:局限在1~2个乳房象限中3分;2级:局限在3~4个乳房象限中6分;3级:局限在5~6个乳房象限中9分;4级:局限在7~8个乳房象限12分。肿块大小,直径1级:肿块直径≤2cm为3分;2级:肿块直径2.1~5cm为6分;3级:肿块直径>5cm为9分。
③比较两组患者中医证候积分。依据《现代中医乳房病学》统计乳房肿块、乳房经前胀痛、胸闷肋胀、少气懒言、舌苔发红、脉弦细数等各项中医证候积分,根据严重程度分为无、轻度、中度、重度,分别评为 0、2、4、6分,分数越高判定为程度越严重。
④比较两组患者内分泌水平。采集两组患者治疗前后清晨空腹静脉血5mL,以3000r/min 转速离心处理10min,取血清,采用酶联免疫吸附实验法测定血清E2、PRL、P水平。
1.7统计学方法
采用SPSS 21.0统计学软件分析数据,计数资料以[例(%)]表示,行χ2检验;计量资料均经K-S法检验符合正态分布,以表示,行t检验。以P<0.05为差异有统计学意义。
2结果
2.1两组治疗效果比较
治疗组总有效率高于对照组,差异有统计学意义(P<0.05),见表8。
2.2两组肿块状态比较
与治疗前比,治疗后两组患者肿块的硬度、范围及大小评分均降低,且治疗组低于对照组,差异均有统计学意义(P<0.05),见表9。
2.3两组中医证候积分比较
与治疗前比,治疗后两组患者乳房肿块、乳房经前胀痛、胸闷肋胀、少气懒言、舌苔发红、脉弦细数等中医证候分值均降低,且治疗组低于对照组,差异均有统计学意义(P<0.05),见表10。
2.4两组内分泌水平比较
与治疗前比,治疗后两组患者血清E2、PRL水平均降低,且治疗组低于对照组;血清P水平均升高,且治疗组高于对照组,差异均有统计学意义(P <0.05),见表11。
3讨论
结果显示,治疗组治疗前后肿块状态、中医证候积分、内分泌水平均有改善,且治疗组疗效显著优于对照组。综上,本发明所述的散结的药物组合物可改善肿块硬度和大小,有效调节机体性激素指标水平,对于乳腺结节疗效显著。
Claims (10)
1.一种散结的药物组合物,其特征在于,按重量份数计,由如下组分组成:夏枯草20-50份、土贝母20-50份、透骨草20-50份、重楼10-30份、山慈菇10-30份、莪术20-50份、川芎20-50份、郁金20-50份、牡蛎20-50份、鹿角霜20-50份。
2.根据权利要求1所述的散结的药物组合物,其特征在于,按重量份数计,由如下组分组成:夏枯草25-40份、土贝母25-40份、透骨草25-40份、重楼13-20份、山慈菇13-20份、莪术25-40份、川芎25-40份、郁金25-40份、牡蛎25-40份、鹿角霜25-40份。
3.根据权利要求2所述的散结的药物组合物,其特征在于,按重量份数计,由如下组分组成:夏枯草28-35份,土贝母28-35份、透骨草28-35份、重楼15-17份、山慈菇15-17份、莪术28-35份、川芎28-35份、郁金28-35份、牡蛎28-35份、鹿角霜28-35份。
4.权利要求1至3任意一项所述的散结的药物组合物的制剂,其特征在于,所述制剂由所述散结的药物组合物添加药学上可接受的辅料,制成制剂。
5.根据权利要求4所述的散结的药物组合物的制剂,其特征在于,所述制剂为凝胶贴膏剂。
6.权利要求5所述的散结的药物组合物的凝胶贴膏剂的制备方法,其特征在于,包括以下步骤:
S1:将EDTA、甘羟铝、聚丙烯酸钠加入甘油中,在反应釜内搅拌均匀,为A相;
S2:将EM-178、AC-10H、促渗剂、防腐剂和加工后的药物组合物加入水中,搅拌混合后,为B相;
S3:将酒石酸加入水中,超声分散,为C相;
S4:将A相、B相、C相混合,真空搅拌均匀,涂布在背衬层,再盖上防粘膜,即得。
7.根据权利要求6所述的散结的药物组合物的凝胶贴膏剂的制备方法,其特征在于,甘油:EDTA:甘羟铝:聚丙烯酸钠:水:药物组合物:EM-178:AC-10H:促渗剂:防腐剂:酒石酸=(250~400g):(0.5~1.5g):(1.0~3.0g):(40~60g):(200~300g):150g:(100~200g):(50~200g):(20~40g):(0.5~2g):(2~4g)。
8.根据权利要求6所述的散结的药物组合物的凝胶贴膏剂的制备方法,其特征在于,步骤S2中,所述加工后的药物组合物为所述药物组合物的水提物、醇提物、挥发油、混合药膏制剂或药粉。
9.权利要求1至3任意一项所述的散结的药物组合物的应用,其特征在于,所述散结的药物组合物在制备行气活血、散结消肿的药物中的应用。
10.权利要求4所述的散结的药物组合物的制剂的应用,其特征在于,所述散结的药物组合物的制剂在制备行气活血、散结消肿的药物中的应用。
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