CN105435192A - 一种治疗子宫肌瘤的外用阴道凝胶及其制作方法 - Google Patents
一种治疗子宫肌瘤的外用阴道凝胶及其制作方法 Download PDFInfo
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- CN105435192A CN105435192A CN201511015984.1A CN201511015984A CN105435192A CN 105435192 A CN105435192 A CN 105435192A CN 201511015984 A CN201511015984 A CN 201511015984A CN 105435192 A CN105435192 A CN 105435192A
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Classifications
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Abstract
一种治疗子宫肌瘤的外用阴道凝胶由按重量份数计的下列组分制成:生地0.5-15份、丹参0.5-15份、红花0.5-10份、枳壳0.5-15份、柴胡0.5-15份、郁金0.5-15份、桔梗0.5-15份、川芎0.5-15份、当归0.5-15份、牛膝0.5-15份、桂枝0.5-5份、茯苓0.5-15份、牡丹皮0.5-15份、赤芍0.5-15份、熟地黄0.5-15份、黄芩0.5-15份、干姜(炒)0.2-1份、延胡索0.5-15份、淫羊藿0.5-15份、吴茱萸0.5-15份、肉苁蓉0.5-15、野菊花0.5-15份、蛇床子0.5-15份、小茴香(炒)0.5-5份、白芨0.5-15份、肉桂0.2-1份、生半夏0.5-5份、麦冬0.5-5份、当归0.5-15份、桃仁0.5-5份、人参0.5-5份、温莪术0.5-15份、黑三棱0.5-15份、艾叶油0.1-0.5份、蒲黄0.5-5份、天花粉0.5-5份、阿胶0.2-1份、酸0.5-5份、碱0.5-5份、表面活性剂3-20份、复配防腐剂0.1-5份、Ph调节剂0.01-2份、增稠剂0.2-10份。本发明有效活血通经,预防和治愈子宫肌瘤。
Description
技术领域
本发明涉及一种治疗妇科病的中药制剂及其制作方法。
背景技术
近些年来,由于饮食、环境、情感、生活方式等的转变,中老年女性子宫肌瘤病例发生率越来越高,肌瘤进展到一定时期发生恶变的也不在少数,现代医学近年虽有醋酸棉酚口服或注射法,但易导致卵巢早衰或提前绝经,大多数医生建议肌瘤长大到一定程度鉴定清楚良恶性后再给予手术治疗,此法有“养虎为患”的嫌疑。
传统中医学认为子宫肌瘤为“气滞血瘀”或“寒凝经脉”或“气血痰火湿邪淤阻”而成“结”、“聚”发展而来,可以通过辨证施治来预防和早期干预,让早中期的肌瘤消之于无形,但多采用口服汤液或丸散的方式给药,长时间达数月的口服苦药,除给肝肾带来了巨大的负担甚至伤害外,也给患者的身心带来极大的痛楚。
发明内容
本发明要解决的技术问题在于:提出一种治疗子宫肌瘤的外用阴道凝胶,可以有效活血通经,预防和治愈子宫肌瘤,是一种可供选择的可以早期实施的预防和治疗子宫肌瘤的方式。
为了解决上述技术问题,本发明提出以下技术方案:一种治疗子宫肌瘤的外用阴道凝胶,其由按重量份数计的下列组分制成:生地0.5-15份、丹参0.5-15份、红花0.5-10份、枳壳0.5-15份、柴胡0.5-15份、郁金0.5-15份、桔梗0.5-15份、川芎0.5-15份、当归0.5-15份、牛膝0.5-15份、桂枝0.5-5份、茯苓0.5-15份、牡丹皮0.5-15份、赤芍0.5-15份、熟地黄0.5-15份、黄芩0.5-15份、干姜(炒)0.2-1份、延胡索0.5-15份、淫羊藿0.5-15份、吴茱萸0.5-15份、肉苁蓉0.5-15、野菊花0.5-15份、蛇床子0.5-15份、小茴香(炒)0.5-5份、白芨0.5-15份、肉桂0.2-1份、生半夏0.5-5份、麦冬0.5-5份、当归0.5-15份、桃仁0.5-5份、人参0.5-5份、温莪术0.5-15份、黑三棱0.5-15份、艾叶油0.1-0.5份、蒲黄0.5-5份、天花粉0.5-5份、阿胶0.2-1份、酸0.5-5份、碱0.5-5份、表面活性剂3-20份、复配防腐剂0.1-5份、Ph调节剂0.01-2份、增稠剂0.2-10份。
上述技术方案的进一步限定在于,所述的酸用于提取,其在中和后无毒性残留,其是下列物质中的一种或多种的混合物:盐酸、柠檬酸、醋酸、乳酸;
所述的碱用于提取,其在中和后无毒性残留,其是下列物质中的一种或多种的混合物:碳酸钠、碳酸钾、碳酸氢钠、碳酸氢钾、氢氧化钠、氢氧化钾、氢氧化钙、氢氧化锌;
所述的表面活性剂温和无毒,是下列物质中的一种或多种的混合物:司盘系列、吐温系列、聚氧乙烯醚系列、泊洛沙姆系列、脂肪酸酯系列、聚甘油脂肪酸酯系列;
所述的复配防腐剂由脂溶性防腐剂和水溶性防腐剂组成,所述脂溶性防腐剂是下列物质中的一种或多种的混合物:对氯间二甲基苯酚、单辛酸甘油酯、单硬脂酸甘油酯、百里香酚、三氯生、三氯卡班、尼泊金酯、醋酸氯己定,所述水溶性防腐剂是下列物质中的一种或多种的混合物:山梨酸钾、苯甲酸钠、尼泊金酯钠盐、脱氢乙酸钠、双乙酸钠、葡萄糖酸氯己定;
所述的Ph调节剂是下列物质中的一种或多种的混合物:盐酸、醋酸、柠檬酸、乳酸、磷酸、氢氧化钠、氢氧化钾、四硼酸钠、三乙醇胺;
所述的增稠剂是下列物质中的一种或多种的混合物:各种天然多糖、改性多糖、泊洛沙姆、卡波姆、聚丙烯酰胺、聚丙烯酸钠以及各种合成接枝共聚物。
为了解决上述技术问题,本发明提出以下技术方案:一种治疗子宫肌瘤的外用阴道凝胶的制作方法,其包括以下步骤:
步骤一,粉碎步骤,取下列组分并粉碎成5-1000目:
生地0.5-15份、丹参0.5-15份、红花0.5-10份、枳壳0.5-15份、柴胡0.5-15份、郁金0.5-15份、桔梗0.5-15份、川芎0.5-15份、当归0.5-15份、牛膝0.5-15份、桂枝0.5-5份、茯苓0.5-15份、牡丹皮0.5-15份、赤芍0.5-15份、熟地黄0.5-15份、黄芩0.5-15份、干姜(炒)0.2-1份、延胡索0.5-15份、淫羊藿0.5-15份、吴茱萸0.5-15份、肉苁蓉0.5-15、野菊花0.5-15份、蛇床子0.5-15份、小茴香(炒)0.5-5份、白芨0.5-15份、肉桂0.2-1份、生半夏0.5-5份、麦冬0.5-5份、当归0.5-15份、桃仁0.5-5份、人参0.5-5份、温莪术0.5-15份、黑三棱0.5-15份;
步骤二,碱提取、脂提取步骤,用40℃-80℃热水100-600份,缓缓溶入碱0.5-5份[A1],搅拌浸泡步骤一得到的粉末3小时后,加入表面活性剂3-20份,和防腐剂0.05-4份,97℃-100℃度文火煎,第一次煎2小时,全离心榨汁取汤待用;
步骤三,酸提取步骤,在步骤二的药渣内第二次加水100-600份,加入酸0.5-5份,搅拌中浸泡1小时,100℃武火煎1小时后,趁热全离心或压榨取汤,弃渣;
步骤四,趁热将步骤二和步骤三所得的液体混合后,用中温55-60℃真空-0.09MPa沸腾冷凝法除去多余水分,浓缩至70-80份,形成药物原液A;
步骤五,把艾叶油0.1-0.5份、蒲黄0.5-5份、天花粉0.5-5份,直接加入原液A,再将阿胶0.2-1份热熔后加入分散,再溶入防腐剂0.05-1份;
步骤六,在步骤五所得溶液中加入增稠剂0.2-10份,搅拌均匀后,称重,补水或旋转蒸发水调节重量至100份,搅匀。
步骤七,加入ph调节剂0.01-2份,调节ph,ph应为4.0~5.0。
步骤八,测试应无菌,分装到凝胶管,每支2-5ml。
与现有技术相比,本发明具有下列有益效果:
本发明遵传统中医学的“内治之药即外治之药,内治之理即外治之理”的原理,精选传统中医药一些明显无毒或低毒性植物药材(阿胶是动物性药材),合理组方,将“补肾益气”,“行气开郁”,“扶正祛邪”,“活血化瘀”,“通络散结”的中医药治疗理论整合为一体,创制了本盆腔靶向用药凝胶,单次给药剂量小,毒副作用低,通过无痛楚阴道反复给药的方式,避开胃肠的首过效应和肝脏的首关消除效应,让其近距离优先靶向分布至盆腔,发挥其调经止带、温经暖宫、通络活血、化淤散结的作用,见效快,效果好,比起口服药剂更胜一筹。
本发明人将凝胶先后试用于1925例,0.5-3cm直径的子宫肌瘤(未鉴定良性恶性)患者,持续用药3月为一疗程,第一疗程结束检查统计,其中,所有1cm以下直径127例患者肌瘤完全消失。1268例肌瘤直径1-3cm患者肌瘤缩小至原有一半以下大小,除16例肌瘤直径无明显减小外,其余患者各有子宫肌瘤直径缩小约三分之一的效果。部分肌瘤消失患者退出试验,1817名患者经继续第二疗程,检查结果证实,肌瘤完全消失者,增加至760人,其余患者不同程度进一步缩小,包括第一疗程无明显缩小的患者此时均缩小50%以上,第三疗程结束,肌瘤完全消失者总数增加至1207,其余患者肌瘤进一步缩小。部分肌瘤消失患者退出试验,1760人继续第四,第五,第六疗程后,肌瘤完全消失总数达1620人,其余140名患者肌瘤进一步缩小。直径最大者0.8,最小者0.3cm,未消失者均为治疗前直径达2.5-3cm者,所有患者经六个疗程(一年半)治疗后全部停药,每半年随访一次,经连续3年随访,所有经治疗者,肌瘤无重复生长,无恶变,表明本发明产品疗效持久肯定。
具体实施方式
本发明提出一种治疗子宫肌瘤的外用阴道凝胶,其由按重量份数计的下列组分制成:生地0.5-15份、丹参0.5-15份、红花0.5-10份、枳壳0.5-15份、柴胡0.5-15份、郁金0.5-15份、桔梗0.5-15份、川芎0.5-15份、当归0.5-15份、牛膝0.5-15份、桂枝0.5-5份、茯苓0.5-15份、牡丹皮0.5-15份、赤芍0.5-15份、熟地黄0.5-15份、黄芩0.5-15份、干姜(炒)0.2-1份、延胡索0.5-15份、淫羊藿0.5-15份、吴茱萸0.5-15份、肉苁蓉0.5-15、野菊花0.5-15份、蛇床子0.5-15份、小茴香(炒)0.5-5份、白芨0.5-15份、肉桂0.2-1份、生半夏0.5-5份、麦冬0.5-5份、当归0.5-15份、桃仁0.5-5份、人参0.5-5份、温莪术0.5-15份、黑三棱0.5-15份、艾叶油0.1-0.5份、蒲黄0.5-5份、天花粉0.5-5份、阿胶0.2-1份、酸0.5-5份、碱0.5-5份、表面活性剂3-20份、复配防腐剂0.1-5份、Ph调节剂0.01-2份、增稠剂0.2-10份。
所述的酸用于提取,其在中和后无毒性残留,其是下列物质中的一种或多种的混合物:盐酸、柠檬酸、醋酸、乳酸。
所述的碱用于提取,其在中和后无毒性残留,其是下列物质中的一种或多种的混合物:碳酸钠、碳酸钾、碳酸氢钠、碳酸氢钾、氢氧化钠、氢氧化钾、氢氧化钙、氢氧化锌。
所述的表面活性剂温和无毒,是下列物质中的一种或多种的混合物:司盘系列、吐温系列、聚氧乙烯醚系列、泊洛沙姆系列、脂肪酸酯系列、聚甘油脂肪酸酯系列。
所述的复配防腐剂由脂溶性防腐剂和水溶性防腐剂组成,所述脂溶性防腐剂是下列物质中的一种或多种的混合物:对氯间二甲基苯酚、单辛酸甘油酯、单硬脂酸甘油酯、百里香酚、三氯生、三氯卡班、尼泊金酯、醋酸氯己定,所述水溶性防腐剂是下列物质中的一种或多种的混合物:山梨酸钾、苯甲酸钠、尼泊金酯钠盐、脱氢乙酸钠、双乙酸钠、葡萄糖酸氯己定。
所述的Ph调节剂是下列物质中的一种或多种的混合物:盐酸、醋酸、柠檬酸、乳酸、磷酸、氢氧化钠、氢氧化钾、四硼酸钠、三乙醇胺。
所述的增稠剂是下列物质中的一种或多种的混合物:各种天然多糖、改性多糖、泊洛沙姆、卡波姆、聚丙烯酰胺、聚丙烯酸钠以及各种合成接枝共聚物。
本发明还提出了上述治疗子宫肌瘤的外用阴道凝胶的制作方法,包括以下步骤:
步骤一,粉碎步骤,取下列组分并粉碎成5-1000目:
生地0.5-15份、丹参0.5-15份、红花0.5-10份、枳壳0.5-15份、柴胡0.5-15份、郁金0.5-15份、桔梗0.5-15份、川芎0.5-15份、当归0.5-15份、牛膝0.5-15份、桂枝0.5-5份、茯苓0.5-15份、牡丹皮0.5-15份、赤芍0.5-15份、熟地黄0.5-15份、黄芩0.5-15份、干姜(炒)0.2-1份、延胡索0.5-15份、淫羊藿0.5-15份、吴茱萸0.5-15份、肉苁蓉0.5-15、野菊花0.5-15份、蛇床子0.5-15份、小茴香(炒)0.5-5份、白芨0.5-15份、肉桂0.2-1份、生半夏0.5-5份、麦冬0.5-5份、当归0.5-15份、桃仁0.5-5份、人参0.5-5份、温莪术0.5-15份、黑三棱0.5-15份;
步骤二,碱提取、脂提取步骤,用40℃-80℃热水100-600份,缓缓溶入碱0.5-5份,搅拌浸泡步骤一得到的粉末3小时后,加入表面活性剂3-20份,和防腐剂0.05-4份,97℃-100℃度文火煎,第一次煎2小时,全离心或压榨取汤待用;
步骤三,酸提取步骤,在步骤二的药渣内第二次加水100-400份,加入酸0.5-5份,搅拌中浸泡1小时,100℃武火煎1小时后,趁热全离心或压榨取汤,弃渣;
步骤四,趁热将步骤二和步骤三所得的液体混合后,用中温55-60℃真空-0.09MPa沸腾冷凝法除去多余水分,浓缩至70-80份,形成药物原液A;
步骤五,把艾叶油0.1-0.5份、蒲黄0.5-5份、天花粉0.5-5份,直接加入原液A,再将阿胶0.2-1份热熔后加入分散,再溶入防腐剂0.05-1份;
步骤六,在步骤五所得溶液中加入增稠剂0.2-10份,搅拌均匀后,称重,补水或旋转蒸发水调节重量至100份,搅匀。
步骤七,加入ph调节剂0.01-2份,调节ph,ph应为4.0~5.0。
步骤八,测试应无菌,分装到凝胶管,每支2-5ml。
上述治疗子宫肌瘤的外用阴道凝胶的使用方法是:经期后临睡觉前阴道宫颈部自行给药,每日一支或隔日一支。三个月为一疗程。
制备实施例1
步骤一,粉碎步骤,取下列药材并粉碎成5-1000目:
生地0.5份、丹参8份、红花0.5份、枳壳15份、柴胡8份、郁金0.5份、桔梗15份、川芎8份、当归0.5份、牛膝15份、桂枝3份、茯苓0.5份、牡丹皮8份、赤芍15份、熟地黄0.5份、黄芩15份、干姜(炒)0.6份、延胡索0.5份、淫羊藿0.5份、吴茱萸15份、肉苁蓉8、野菊花8份、蛇床子0.5份、小茴香(炒)5份、白芨8份、肉桂0.2份、生半夏0.5份、麦冬5份、当归8份、桃仁0.5份、人参0.5份、温莪术15份、黑三棱8份;
步骤二,碱提取、脂提取步骤,用40℃-80℃热水300份,缓缓溶入碱0.5份,[A2]搅拌浸泡步骤一得到的粉末3小时后,加入表面活性剂泊洛沙姆188*3份,和耐热的脂溶性防腐剂单辛酸甘油酯2份,文火97℃-100℃煎第一次煎2小时,全离心榨汁取汤待用;
步骤三,酸提取步骤,在步骤二的药渣内第二次加水280份,加入盐酸0.3份,搅拌中浸泡1小时,100℃武火煎1小时后,趁热全全离心或压榨取汤,弃渣;
步骤四,趁热将步骤二和步骤三所得的液体混合后,用中温55-60℃真空-0.09MPa沸腾冷凝法除去多余水分,浓缩至70-80份,形成药物原液A;
步骤五,把艾叶油0.1份、蒲黄3份、天花粉5份,直接加入原液A,再将阿胶0.5份热熔后加入分散,再溶入水溶性防腐剂0.5份;
步骤六,在步骤五所得溶液中加入增稠剂卡波姆SF-1*8份,搅拌均匀后,称重,补水或旋转蒸发水调节重量至100份,搅匀
步骤七,先后加入ph调节剂氢氧化钠1份和醋酸0。01份,调节ph,ph应为4.0~5.0。
步骤八,测试应无菌,分装到凝胶管,每支2-5ml。
制备实施例2
步骤一,粉碎步骤,取下列药材并粉碎成5-1000目:
生地15份、丹参0.5份、红花10份、枳壳8份、柴胡0.5份、郁金15份、桔梗8份、川芎15份、当归8份、牛膝0.5份、桂枝0.5份、茯苓8份、牡丹皮0.5份、赤芍0.5份、熟地黄8份、黄芩0.5份、干姜(炒)0.2份、延胡索15份、淫羊藿8份、吴茱萸0.5份、肉苁蓉0.5、野菊花15份、蛇床子8份、小茴香(炒)0.5份、白芨0.5份、肉桂1份、生半夏3份、麦冬3份、当归0.5份、桃仁5份、人参3份、温莪术0.5份、黑三棱15份;
步骤二,碱提取、脂提取步骤,用50℃热水500份,缓缓溶入碱-碳酸钾3份,搅拌浸泡步骤一得到的粉末3小时后,加入表面活性剂-脂肪醇聚氧乙烯醚AEO-9*10份,和耐热的脂溶性防腐剂三氯生0.2份,文火煎2小时,全离心榨汁取汤待用;
步骤三,酸提取步骤,在步骤二的药渣内第二次加水250份,加入酸-醋酸4份,搅拌中浸泡1小时,100℃煎1小时后,趁热全离心或压榨取汤,弃渣;
步骤四,趁热将步骤二和步骤三所得的液体混合后,用中温55-60℃真空-0.09MPa沸腾冷凝法除去多余水分,浓缩至70-80份,形成药物原液A;
步骤五,把艾叶油0.3份、蒲黄0.5份、天花粉3份,直接加入原液A,再溶入水溶性防腐剂尼泊金乙酯钠0.15份;
步骤六,在步骤五所得溶液中加入增稠剂海藻酸钠2份,搅拌均匀后,称重,补水或旋转蒸发水调节重量到100份,搅匀;
步骤七,先后加入ph调节剂氢氧化钠和乳酸共2份,调节ph,ph应为4.0~5.0。
步骤八,测试应无菌,分装到凝胶管,每支2-5ml。
制备实施例3
步骤一,粉碎步骤,取下列药材并粉碎成5-1000目:
生地8份、丹参15份、红花5份、枳壳0.5份、柴胡15份、郁金8份、桔梗0.5份、川芎0.5份、当归15份、牛膝8份、桂枝5份、茯苓15份、牡丹皮15份、赤芍8份、熟地黄15份、黄芩8份、干姜(炒)1份、延胡索8份、淫羊藿15份、吴茱萸8份、肉苁蓉15、野菊花0.5份、蛇床子15份、小茴香(炒)3份、白芨15份、肉桂0.5份、生半夏5份、麦冬0.5份、当归15份、桃仁3份、人参5份、温莪术8份、黑三棱0.5份;
步骤二,碱提取、脂提取步骤,用40℃-80℃热水500份,缓缓溶入碱-氢氧化钠5份,搅拌浸泡步骤一得到的粉末3小时后,加入表面活性剂聚氧乙烯氢化蓖麻油40*10份,和耐热的脂溶性防腐剂三氯卡班0.2份,文火97℃-100℃煎2小时,全离心榨汁取汤待用;
步骤三,酸提取步骤,在步骤二的药渣内第二次加水400份,加入酸-乳酸5份,搅拌中浸泡1小时,100-102摄氏度煎1小时后,趁热全离心或压榨取汤,弃渣;
步骤四,趁热将步骤二和步骤三所得的液体混合后,用中温55-60℃真空-0.09MPa沸腾冷凝法除去多余水分,浓缩至70-80份,形成药物原液A;
步骤五,把艾叶油0.5份、蒲黄5份、天花粉0.5份,直接加入原液A,再将阿胶0.6份热熔后加入分散,再溶入水溶性防腐剂山梨酸钾0.5份;
步骤六,在步骤五所得溶液中加入增稠剂黄原胶1份,搅拌均匀后,称重,补水或旋转蒸发水调节重量直到100份,搅匀;
步骤七,先后加入ph调节剂氢氧化钠和乳酸共1份,调节ph,ph应为4.0~5.0。
步骤八,测试应无菌,分装到凝胶管,每支2-5ml。
下面列举几个用本发明治疗子宫肌瘤的外用阴道凝胶的病例。
病例一
汪*萍,浙江绍兴人,47岁。2007年体检发现子宫底肌瘤2个,直径分别为23mm和12mm,2008年1月开始使用本凝胶,一个疗程(3个月)后,大肌瘤直径变小为0.8,小肌瘤消失,继续使用2疗程后,肌瘤完全消失。该患者肌瘤消失后仍然行经2年至50岁方停经,随访5年未复发。
病例二
陈*华,深圳市人,42岁,2007年初,停经半年不至,小腹微凉,影像检查见子宫后壁一直径8mm肌瘤,余无明显异常,经中西医治疗半年,月经仍不通。2007年底来诊,本发明人观其气血虽不虚,然舌色暗紫,舌下腺体迂曲,左尺脉沉涩,兼有下腹微凉,为少腹气血淤阻之相,建议使用本发明制剂,8次(8天)后,月经复通,经后继续使用满2个疗程(6个月),月事以时下,经量,经色,周期完全恢复正常,肌瘤消失。随访6年,月经一直正常,肌瘤无复发。
病例三
朱*淑,江西南昌人,37岁,2006年5月,查体见子宫内二肌瘤,直径分别为10mm.和7mm,余无异常,经多方治疗一年,肌瘤反而有增大趋势,2007年7月经影像检查,确定直径分别为13mm,9mm。2007年8月开始使用本发明制剂,2个疗程(6个月)后,肌瘤完全消失,继续使用2个疗程后停药。随访8年无复发。
病例四
楚英华,哈尔滨人,50岁,就诊前三年发现经血时间过长,误以为是更年期症状,未予重视,2010年3月检查见子宫后壁肌瘤2枚,直径分别为11mm、17mm,2010年5月,开始使用本发明制剂,一个疗程(3个月)后,子宫肌瘤消失,子宫无异常出血。继续一个疗程后停药,随访5年未复发。
病例五
蒋珍珠,广西柳州市人,39岁,经期腹痛,淋漓不尽数年,2010年4月经影像确诊为子宫腺肌症,2010年6月开始使用本发明制剂,一个疗程(3个月)后,经期腹痛症状明显减轻,两个疗程后,超声波下见子宫肌层透光均匀,已无腺样体存在,经期腹痛症状完全消失。继续两个疗程后停药,2011年9月,即将行经前经影像诊断,子宫肌层透声均匀正常,肌层内无低回声腺样充血区存在,腺肌症已彻底康复。随访4年,未再复发。
病例六
张香香,北京人,27岁,2011年8月,因经期紊乱,情绪烦躁,乳房胀痛来诊治,本发明人观察其善太息,乃肝气不舒之相,予制剂治疗一个疗程后,行经恢复正常,情绪良好,乳房不再胀痛,随访两年未复发。
本发明具有下列有益效果:
本发明人遵传统中医学“内治之药即外治之药,内治之理即外治之理”的原理,精选传统中医药一些明显无毒或低毒性植物药材(阿胶是动物性药材),合理组方,将补肾益气,扶正祛邪,行气开郁,活血化瘀,通络散结的中医药治疗理论整合为一体,创制了本盆腔靶向用药凝胶,单次给药剂量小,毒副作用低,通过无痛楚阴道反复给药的方式,避开胃肠的首过效应和肝脏的首关消除效应,让其近距离优先靶向分布至盆腔,发挥其调经止带、温经暖宫、通络活血、化淤散结的作用,见效快,效果好,比起口服药剂更胜一筹。
本发明人将凝胶先后试用于1925例,0.5-3cm直径的子宫肌瘤(未鉴定良性恶性)患者,持续用药3月为一疗程,第一疗程结束检查统计,其中,所有1cm以下直径127例患者肌瘤完全消失。1268例肌瘤直径1-3cm患者肌瘤缩小至原有一半以下大小,除16例肌瘤直径无明显减小外,其余患者各有子宫肌瘤直径缩小约三分之一的效果。部分肌瘤消失患者退出试验,1817名患者经继续第二疗程,检查结果证实,肌瘤完全消失者,增加至760人,其余患者不同程度进一步缩小,包括第一疗程无明显缩小的患者此时均缩小50%以上,第三疗程结束,肌瘤完全消失者总数增加至1207,其余患者肌瘤进一步缩小。部分肌瘤消失患者退出试验,1760人继续第四,第五,第六疗程后,肌瘤完全消失总数达1620人,其余140名患者肌瘤进一步缩小。直径最大者0.8,最小者0.3cm,未消失者均为治疗前直径达2.5-3cm者,所有患者经六个疗程(一年半)治疗后全部停药,每半年随访一次,经连续3年随访,所有经治疗者,肌瘤无重复生长,无恶变,表明本发明产品疗效持久肯定。
本发明产品同时开创了阴道用药调理月经的新途径,本发明产品补肾、暖宫、舒肝理气、养血、活血、化瘀、通络。最快通过持续7-14天的疗程即可调理好因气血不和或宫寒血瘀引起的经少、经闭、经量过多、经期过长等症,达到经血复通、经量正常、经期规律的效果。
Claims (4)
1.一种治疗子宫肌瘤的外用阴道凝胶,其特征在于,其由按重量份数计的下列组分制成:生地0.5-15份、丹参0.5-15份、红花0.5-10份、枳壳0.5-15份、柴胡0.5-15份、郁金0.5-15份、桔梗0.5-15份、川芎0.5-15份、当归0.5-15份、牛膝0.5-15份、桂枝0.5-5份、茯苓0.5-15份、牡丹皮0.5-15份、赤芍0.5-15份、熟地黄0.5-15份、黄芩0.5-15份、干姜(炒)0.2-1份、延胡索0.5-15份、淫羊藿0.5-15份、吴茱萸0.5-15份、肉苁蓉0.5-15、野菊花0.5-15份、蛇床子0.5-15份、小茴香(炒)0.5-5份、白芨0.5-15份、肉桂0.2-1份、生半夏0.5-5份、麦冬0.5-5份、当归0.5-15份、桃仁0.5-5份、人参0.5-5份、温莪术0.5-15份、黑三棱0.5-15份、艾叶油0.1-0.5份、蒲黄0.5-5份、天花粉0.5-5份、阿胶0.2-1份、酸0.5-5份、碱0.5-5份、表面活性剂3-20份、复配防腐剂0.1-5份、Ph调节剂0.01-2份、增稠剂0.2-10份。
2.根据权利要求1所述的治疗子宫肌瘤的外用阴道凝胶,其特征在于,
所述的酸用于提取,其在中和后无毒性残留,其是下列物质中的一种或多种的混合物:盐酸、柠檬酸、醋酸、乳酸;
所述的碱用于提取,其在中和后无毒性残留,其是下列物质中的一种或多种的混合物:碳酸钠、碳酸钾、碳酸氢钠、碳酸氢钾、氢氧化钠、氢氧化钾、氢氧化钙、氢氧化锌;
所述的表面活性剂温和无毒,是下列物质中的一种或多种的混合物:司盘系列、吐温系列、聚氧乙烯醚系列、泊洛沙姆系列、脂肪酸酯系列、聚甘油脂肪酸酯系列;
所述的复配防腐剂由脂溶性防腐剂和水溶性防腐剂组成,所述脂溶性防腐剂是下列物质中的一种或多种的混合物:对氯间二甲基苯酚、单辛酸甘油酯、单硬脂酸甘油酯、百里香酚、三氯生、三氯卡班、尼泊金酯、醋酸氯己定,所述水溶性防腐剂是下列物质中的一种或多种的混合物:山梨酸钾、苯甲酸钠、尼泊金酯钠盐、脱氢乙酸钠、双乙酸钠、葡萄糖酸氯己定;
所述的Ph调节剂是下列物质中的一种或多种的混合物:盐酸、醋酸、柠檬酸、乳酸、磷酸、氢氧化钠、氢氧化钾、四硼酸钠、三乙醇胺;
所述的增稠剂是下列物质中的一种或多种的混合物:各种天然多糖、改性多糖、泊洛沙姆、卡波姆、聚丙烯酰胺、聚丙烯酸钠以及各种合成接枝共聚物。
3.一种如权利要求1所述的治疗子宫肌瘤的外用阴道凝胶的制作方法,其特征在于,其包括以下步骤:
步骤一,粉碎步骤,取下列组分并粉碎成5-1000目:
生地0.5-15份、丹参0.5-15份、红花0.5-10份、枳壳0.5-15份、柴胡0.5-15份、郁金0.5-15份、桔梗0.5-15份、川芎0.5-15份、当归0.5-15份、牛膝0.5-15份、桂枝0.5-5份、茯苓0.5-15份、牡丹皮0.5-15份、赤芍0.5-15份、熟地黄0.5-15份、黄芩0.5-15份、干姜(炒)0.2-1份、延胡索0.5-15份、淫羊藿0.5-15份、吴茱萸0.5-15份、肉苁蓉0.5-15、野菊花0.5-15份、蛇床子0.5-15份、小茴香(炒)0.5-5份、白芨0.5-15份、肉桂0.2-1份、生半夏0.5-5份、麦冬0.5-5份、当归0.5-15份、桃仁0.5-5份、人参0.5-5份、温莪术0.5-15份、黑三棱0.5-15份;
步骤二,碱提取、脂提取步骤,用40℃-80℃热水100-600份,缓缓溶入碱0.5-5份,搅拌浸泡步骤一得到的粉末3小时后,加入表面活性剂3-20份,和防腐剂0.05-4份,97℃-101℃度文火煎,第一次煎2小时,全离心或压榨取汤待用;
步骤三,酸提取步骤,在步骤二的药渣内第二次加水100-600份,加入酸0.5-5份,搅拌中浸泡1小时,100℃煎1小时后,趁热全离心或压榨取汤,弃渣;
步骤四,趁热将步骤二和步骤三所得的液体混合后,用中温55℃-60℃真空-0.09MPa沸腾冷凝法除去多余水分,浓缩至70-80份,形成药物原液A;
步骤五,把艾叶油0.1-0.5份、蒲黄0.5-5份、天花粉0.5-5份,直接加入原液A,再将阿胶0.2-1份热熔后加入分散,再溶入防腐剂0.05-1份;
步骤六,在步骤五所得溶液中加入增稠剂0.2-10份,搅拌均匀后,称重,补水或旋转蒸发水调节重量至100份,搅匀;
步骤七,加入ph调节剂0.01-2份,调节ph,ph应为4.0~5.0;
步骤八,测试应无菌,分装到凝胶管,每支2-5ml。
4.根据权利要求3所述的治疗子宫肌瘤的外用阴道凝胶的制作方法,其特征在于,所述的酸用于提取,其在中和后无毒性残留,其是下列物质中的一种或多种的混合物:盐酸、柠檬酸、醋酸、乳酸;
所述的碱用于提取,其在中和后无毒性残留,其是下列物质中的一种或多种的混合物:碳酸钠、碳酸钾、碳酸氢钠、碳酸氢钾、氢氧化钠、氢氧化钾、氢氧化钙、氢氧化锌;
所述的表面活性剂温和无毒,是下列物质中的一种或多种的混合物:司盘系列、吐温系列、聚氧乙烯醚系列、泊洛沙姆系列、脂肪酸酯系列、聚甘油脂肪酸酯系列;
所述的复配防腐剂由脂溶性防腐剂和水溶性防腐剂组成,所述脂溶性防腐剂是下列物质中的一种或多种的混合物:对氯间二甲基苯酚、单辛酸甘油酯、单硬脂酸甘油酯、百里香酚、三氯生、三氯卡班、尼泊金酯、醋酸氯己定,所述水溶性防腐剂是下列物质中的一种或多种的混合物:山梨酸钾、苯甲酸钠、尼泊金酯钠盐、脱氢乙酸钠、双乙酸钠、葡萄糖酸氯己定;
所述的Ph调节剂是下列物质中的一种或多种的混合物:盐酸、醋酸、柠檬酸、乳酸、磷酸、氢氧化钠、氢氧化钾、四硼酸钠、三乙醇胺;
所述的增稠剂是下列物质中的一种或多种的混合物:各种天然多糖、改性多糖、泊洛沙姆、卡波姆、聚丙烯酰胺、聚丙烯酸钠以及各种合成接枝共聚物。
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CN112516207A (zh) * | 2020-12-14 | 2021-03-19 | 欧迪玛(湖北)生物科技有限公司 | 预防子宫肌瘤的凝胶组合物及其制备方法和应用 |
CN115518029A (zh) * | 2021-06-12 | 2022-12-27 | 左点实业(湖北)有限公司 | 一种卡波姆阴道填塞凝胶 |
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