CN103751727B - 一种治疗宫外孕的药物组合物及其应用 - Google Patents
一种治疗宫外孕的药物组合物及其应用 Download PDFInfo
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Abstract
本发明涉及一种治疗宫外孕的药物组合物及其应用，该药物组合物由如下重量份的中药材原料制备而成：浮小麦12-20份、莪术15-25份、老鼠耳8-15份、紫石英8-15份、黄芩21-30份、红花10-20份、锁阳6-12份、远志10-20份。本发明的该药物组合物能达到活血杀胚和化瘀消瘾的药用功效，又大幅度降低了西药的胃肠道刺激和肝功能损害等毒副反应发生率。
Description
技术领域
本发明属于中医药技术领域，具体涉及一种治疗宫外孕的药物组合物及其应用。
背景技术
官外孕是指非官腔内正常妊娠，由于各种原因，受精卵不能到达并正常着床于子宫体部内膜所致，并最终以流产或破裂而终结。宫外孕95％-98％发生在输卵管，其中55%-60%为壶腹部妊娠，且大部分为流产型，内出血量不多。
近年来，宫外孕的发病机率逐年增加，其患病群体也不断扩大，越来越多的女性受到此种病症的困扰。宫外孕在某种程度上可导致患者腹腔内大量出血或反复破裂出血现象的发生和发展。以往一旦确诊后便采用外科手术疗法对其进行治疗，但由于受到手术创伤性大且出血量多等因素的影响而不易于被患者所接受和认可。随着对子宫外孕发病机制认识和研究的不断深入，再加之高敏感血清HCG和阴道彩超等全新诊疗技术在子宫外孕中的广泛应用，从而为子宫外孕的药物保守治疗奠定了坚实的基础。
发明内容
本发明的目的在于提供一种治疗宫外孕的药物组合物及应用。该药物组合物是在祖传秘方基础上改进而得，能达到活血杀胚和化瘀消瘾的药用功效，又大幅度降低了西药的胃肠道刺激和肝功能损害等毒副反应发生率，是一种治疗宫外孕的特效药。
本发明的目的是这样实现的：
一种治疗宫外孕的药物组合物，它由包含如下重量份的中药材原料制备而成：浮小麦12-20份、莪术15-25份、老鼠耳8-15份、紫石英8-15份、黄芩21-30份、红花10-20份、锁阳6-12份、远志10-20份。
优选地，如上所述的治疗宫外孕的药物组合物，它由如下重量份的中药材原料制备而成：浮小麦14-17份、莪术18-22份、老鼠耳10-12份、紫石英10-12份、黄芩24-26份、红花13-16份、锁阳8-9份、远志13-16份。
在本发明的一个最优选的实施例中，如上所述的治疗宫外孕的药物组合物由如下重量份的中药材原料制备而成：浮小麦15份、莪术20份、老鼠耳11份、紫石英11份、黄芩25份、红花14份、锁阳8份、远志14份。
通过试验研究发现，本发明所述的药物组合物具有活血杀胚和化瘀消瘾的药用功效。因此，本发明的第二个目的在于提供一种制药用途，即上述药物组合物在制备治疗宫外孕的药物中的应用。
优选地，在制药应用时所述的药物为口服制剂。进一步优选地，所述的口服制剂包括口服液、片剂、胶囊、颗粒剂。
本发明涉及的药物组合物的制备方法包括如下步骤：（1）取处方量的浮小麦12-20份、莪术15-25份、老鼠耳8-15份、紫石英8-15份、黄芩21-30份、红花10-20份、锁阳6-12份和远志10-20份，洗净去杂，晾干，粉碎；（2）再将上述颗粒状药材加水漫过药面2cm，浸泡1-1.2h，捞出药材置多功能提取灌中加水煎煮二次，第一次加总药材8-10倍量的水，煎煮2h，取煎液，滤过，第二次加总药材6-8倍量的水，煎煮1h，取两次煎液合并，滤过，浓缩至90℃时相对密度为1.15g/mL的浓缩液；（3）将浓缩液置0-5℃低温冷藏24h，将冷藏液加0.3%的助滤剂硅藻土，滤过，滤液再浓缩至每毫升含3g生药量，置0-5℃低温冷藏24h，将冷藏液滤过，得药液。
与现有技术相比，本发明的该药物组合物能达到活血杀胚和化瘀消瘾的药用功效，又大幅度降低了西药的胃肠道刺激和肝功能损害等毒副反应发生率。
具体实施方式
需要说明的是，本发明实施例所采用的中药材原料的来源如下：浮小麦选用禾本科小麦属植物小麦TriticumaestivumL.的干燥轻浮瘪瘦的果实。莪术选用姜科植物桂莪术CurcuamkwangsiensisS.G.LesetC.F.Liang的根茎。老鼠耳选用鼠李科植物老鼠耳Berchemialineata(L.)DC.的干燥嫩茎叶。紫石英选用氟化物类矿物萤石族萤石，主要含有氟化钙。黄芩选用唇形科植物黄芩ScutellariabaicalensisGeorgi的干燥根。红花选用菊科植物红花CarthamustinctoriusL.的筒状花冠。锁阳选用锁阳科植物锁阳CynomoriumsongaricumRupr.的干燥肉质茎。远志选用远志科植物远志PolygalatenuifoliaWilld．和卵叶远志P.sibiricaL.的干燥根。
以下是本发明的具体实施例，对本发明的技术方案进一步作描述，但是本发明的保护范围并不限于这些实施例。凡是不背离本发明构思的改变或等同替代均包括在本发明的保护范围之内。
实施例1
称取浮小麦1.5kg、莪术2.0kg、老鼠耳1.1kg、紫石英1.1kg、黄芩2.5kg、红花1.4kg、锁阳0.8kg和远志1.4kg，洗净去杂，晾干，粉碎；再将上述颗粒状药材加水漫过药面2cm，浸泡1-1.2h，捞出药材置多功能提取灌中加水煎煮二次，第一次加总药材10倍量的水，煎煮2h，取煎液，滤过，第二次加总药材8倍量的水，煎煮1h，取两次煎液合并，滤过，浓缩至90℃时相对密度为1.15g/mL的浓缩液；将浓缩液置0-5℃低温冷藏24h，将冷藏液加0.3%的助滤剂硅藻土，滤过，滤液再浓缩至每毫升含3g生药量，置0-5℃低温冷藏24h，将冷藏液滤过，得药液。
实施例2
称取浮小麦1.7kg、莪术2.2kg、老鼠耳1.2kg、紫石英1.0kg、黄芩2.1kg、红花1.0kg、锁阳1.0kg和远志1.0kg，洗净去杂，晾干，粉碎；再将上述颗粒状药材加水漫过药面2cm，浸泡1-1.2h，捞出药材置多功能提取灌中加水煎煮二次，第一次加总药材8倍量的水，煎煮2h，取煎液，滤过，第二次加总药材8倍量的水，煎煮1h，取两次煎液合并，滤过，浓缩至90℃时相对密度为1.15g/mL的浓缩液；将浓缩液置0-5℃低温冷藏24h，将冷藏液加0.3%的助滤剂硅藻土，滤过，滤液再浓缩至每毫升含3g生药量，置0-5℃低温冷藏24h，将冷藏液滤过，得药液。
实施例3
称取浮小麦2.0kg、莪术2.5kg、老鼠耳0.8kg、紫石英1.2kg、黄芩2.5kg、红花1.6kg、锁阳0.9kg和远志1.5kg，洗净去杂，晾干，粉碎；再将上述颗粒状药材加水漫过药面2cm，浸泡1-1.2h，捞出药材置多功能提取灌中加水煎煮二次，第一次加总药材8倍量的水，煎煮2h，取煎液，滤过，第二次加总药材6倍量的水，煎煮1h，取两次煎液合并，滤过，浓缩至90℃时相对密度为1.15g/mL的浓缩液；将浓缩液置0-5℃低温冷藏24h，将冷藏液加0.3%的助滤剂硅藻土，滤过，滤液再浓缩至每毫升含3g生药量，置0-5℃低温冷藏24h，将冷藏液滤过，得药液。
实施例4
称取浮小麦1.2kg、莪术1.5kg、老鼠耳1.5kg、紫石英1.5kg、黄芩3.0kg、红花2.0kg、锁阳1.2kg和远志2.0kg，洗净去杂，晾干，粉碎；再将上述颗粒状药材加水漫过药面2cm，浸泡1-1.2h，捞出药材置多功能提取灌中加水煎煮二次，第一次加总药材8倍量的水，煎煮2h，取煎液，滤过，第二次加总药材6倍量的水，煎煮1h，取两次煎液合并，滤过，浓缩至90℃时相对密度为1.15g/mL的浓缩液；将浓缩液置0-5℃低温冷藏24h，将冷藏液加0.3%的助滤剂硅藻土，滤过，滤液再浓缩至每毫升含3g生药量，置0-5℃低温冷藏24h，将冷藏液滤过，得药液。
实施例5中药口服液对宫外孕患者的疗效和毒副反应研究
经相关检查和明确诊断后确诊的输卵管性宫外孕患者53例，年龄22-37岁之间，平均年龄为28.1±2.5岁；孕龄4-10周，全部为未产妇。所有患者随机分为试验组（27例）和对照组（26例），两组患者患者的年龄、孕龄、病情等资料差异不明显，具有可比性。
对照组患者给予西药临床治疗，具体给药方法：注射用甲氨蝶呤60mg/m2，肌肉注射1次/d，1周为1个疗程；米非司酮片75mg，空腹口服2次/d，l周为1个疗程，2个疗程后统计疗效。试验组患者口服本发明实施例1处方和方法制备的中药口服液，每天早中晚各一次，每次25mL；1周为一个疗程，共服用1-3个疗程后统计疗效。所有患者在临床治疗过程中每7d对两组子宫外孕患者进行血人绒毛膜促性腺激素(HCG)和彩超的监测和复查，并以此判断是否有效和指导后续临床用药。
分别比较和分析两组子宫外孕患者的临床疗效和毒副反应，根据《实用中西结合同妇产科学》将临床疗效的评定标准分为：(1)痊愈：患者经治疗后自觉症状和体征消失，妊娠试验阴性，血HCG正常，盆腔包块消失；(2)显效：患者经治疗后主要症状和体征消失，盆腔包块缩小，血HCG降幅度在15％以上；(3)有效：患者经治疗后症状和体征好转，盆腔包块缩小或无增大，血HCG有所下降；(4)无效：患者经治疗后症状和体征未改善或加重，盆腔包块增大或无变化，血HCG不降或升高。总有效率为痊愈率和显效率及有效率之和。其中毒副反应的考察项目包括胃肠道刺激和肝功能损害。
治疗后两组临床疗效比较具体试验结果见表1，根据表1的结果可见，试验组患者的总有效率分别为92.59%，明显高于对照组患者的69.23%。
表1试验组和对照组患者的临床疗效比较（例）
试验组患者胃肠道刺激和肝功能损害的毒副反应发生率较对照组患者均有显著降低，结果见表2。
表2试验组与对照组患者毒副反应比较【例（%）】
典型应用例：连某，女，27岁。停经51天，阴道不规则流血10天，伴腹痛4天，平时月经准时(≥28)，无生育史，人流1次。妇检宫颈无提举痛，宫体前位，大小正常，左附件触及一2cm×3cm×2cm大小包块。HCG阳性，血β-hCGl6ng/ml，B超显示宫内无妊娠囊，左附件包块3.6cm×2.6cm，直肠窦积液2.6cm×3cm。即行诊刮术并收住人院，病检示内膜呈蜕膜变化。采用本发明方剂（浮小麦15g、莪术20g、老鼠耳11g、紫石英11g、黄芩25g、红花14g、锁阳8g、远志14g）主治，7剂。服上药3剂后已无腹痛及阴道流血，查血β-hCG2.9ng/ml，尿HCG转阴，B超示左附件包块3.4cm×2.6cm，再服药2周，B超复查包块已消失，直肠窦积液消失。
Claims (3)
1.一种治疗宫外孕的药物组合物，其特征在于所述的药物组合物由如下重量份的中药材原料制备而成：浮小麦15份、莪术20份、老鼠耳11份、紫石英11份、黄芩25份、红花14份、锁阳8份、远志14份；
所述药物组合物由如下制备方法制得：（1）称取浮小麦、莪术、老鼠耳、紫石英、黄芩、红花、锁阳和远志，洗净去杂，晾干，粉碎；（2）再将上述颗粒状药材加水漫过药面2cm，浸泡1-1.2h，捞出药材置多功能提取罐中加水煎煮二次，第一次加总药材8-10倍量的水，煎煮2h，取煎液，滤过，第二次加总药材6-8倍重量的水，煎煮1h，取两次煎液合并，滤过，浓缩至90℃时相对密度为1.15的浓缩液；（3）将浓缩液置0-5℃低温冷藏24h，将冷藏液加0.3%的助滤剂硅藻土，滤过，滤液再浓缩至每毫升含3g生药量，置0-5℃低温冷藏24h，将冷藏液滤过，即得。
2.根据权利要求1的治疗宫外孕的药物组合物，其特征在于：所述的药物组合物为口服制剂。
3.根据权利要求2的治疗宫外孕的药物组合物，其特征在于：所述的口服制剂为口服液、片剂、胶囊或颗粒剂。
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