CN105998999A - 妇科再造制剂在制备防治肿瘤及其并发症药物中的应用 - Google Patents

妇科再造制剂在制备防治肿瘤及其并发症药物中的应用 Download PDF

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CN105998999A
CN105998999A CN201610412166.3A CN201610412166A CN105998999A CN 105998999 A CN105998999 A CN 105998999A CN 201610412166 A CN201610412166 A CN 201610412166A CN 105998999 A CN105998999 A CN 105998999A
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radix
parts
processed
rhizoma
preparation
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CN105998999B (zh
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尚秘
王海洋
刘莉
张仕林
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Hanfang Pharma Co ltd
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GUIZHOU HANFANG PHARMACEUTICAL CO Ltd
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Abstract

本发明提供了妇科再造制剂在制备治疗肿瘤及其并发症的药物中的应用。所述妇科再造制剂制剂由酒当归、醋炙香附、白芍、熟地黄、阿胶、茯苓、党参、黄芪、山药、白术、酒蒸女贞子、醋炙龟甲、山茱萸、续断、盐杜仲、肉苁蓉、覆盆子、鹿角霜、川芎、丹参、牛膝、益母草、延胡索、油酥三七、醋炙艾叶、小茴香、藁本、海螵蛸、醋炙地榆、益智、泽泻、醋炙荷叶、秦艽、地骨皮、白薇、椿皮、琥珀、酒黄芩、酸枣仁、制远志、陈皮、甘草及辅料制成，所述妇科再造制剂制剂能有效治疗肿瘤及其并发症，所述的肿瘤包括妇科肿瘤，所述的妇科肿瘤包括外阴癌，阴道癌，宫颈癌，子宫内膜癌，卵巢癌或乳腺癌，具有良好的应用前景。

Description

妇科再造制剂在制备防治肿瘤及其并发症药物中的应用
技术领域
本发明涉及妇科再造制剂的应用，特别涉及妇科再造制剂在制备预防或治疗肿瘤及其并发症的药物中的应用。
背景技术
肿瘤(tumour)是指机体在各种致瘤因子作用下，局部组织细胞增生所形成的新生物(neogrowth)，因为这种新生物多呈占位性块状突起，也称赘生物(neoplasm)。根据新生物的细胞特性及对机体的危害性程度，又将肿瘤分为良性肿瘤和恶性肿瘤两大类，而癌症即为恶性肿瘤的总称。需要注意的是，癌症与癌是两个不同的概念，癌指的是上皮性的恶性肿瘤，如由大肠黏膜上皮形成的恶性肿瘤称为大肠黏膜上皮癌，简称大肠癌。由皮肤上皮形成的称皮肤上皮癌，简称皮肤癌等等。白血病是一种血液系统的恶性肿瘤，所以俗称血癌。它是由骨髓中某型未成熟的白细胞弥漫性恶性生长，取代正常骨髓组织并进入血液中形成的。因在患者的血液中出现大量的这种肿瘤性白细胞，以致血液呈现乳糜样颜色的特征，因此人们便称它为白血病，其实此病名未能反映出它的癌细胞的生物学分类特征。在极大多数病例中，血液白细胞数量明显增多，但有时也可正常甚至减少。按白血病细胞的类型，可分为粒细胞型、淋巴细胞型、单核细胞型等3种。良性肿瘤与恶性肿瘤的主要区别：良性肿瘤生长缓慢，有包膜，膨胀性生长，摸之有滑动，边界清楚，不转移，预后一般良好，有局部压迫症状，一般无全身症状，通常不会引起患者死亡；恶性肿瘤(癌)生长迅速，侵袭性生长，与周围组织粘连，摸之不能移动，边界不清，易发生转移，治疗后易复发，早期即可能有低热、食欲差、体重下降、晚期可出现严重消，瘦、贫血、发热等，如不及时治疗，常导致死亡。
肿瘤在本质上是基因病。各种环境的和遗传的致癌因素以协同或序贯的方式引起DNA损害，从而激活原癌基因和(或)灭活肿瘤抑制基因，加上凋亡调节基因和(或)DNA修复基因的改变，继而引起表达水平的异常，使靶细胞发生转化。被转化的细胞先多呈克隆性的增生，经过一个漫长的多阶段的演进过程，其中一个克隆相对无限制的扩增，通过附加突变，选择性地形成具有不同特点的亚克隆(异质化)，从而获得浸润和转移的能力(恶性转化)，形成恶性肿瘤。内因如果机体内部的某些条件或状况适合外界环境中致癌物质的作用，这些人群就具备了癌症发病的内因。包括精神因素、内分泌失调、免疫缺陷与遗传因素等。约有60％的癌症患者在发病前有明显的精神创伤史。内分泌紊乱可能与乳腺癌、前列腺癌发病有关。先天性免疫缺陷或长期应用免疫抑制药的人群中，肿瘤的发病率较高。遗传因素与癌 的发病有密切关系，如患有错构瘤病综合征、遗传性皮肤病、染色体脆弱综合征等遗传病者，约10％发生恶性肿瘤，一些致癌外因诱发肿瘤时也都通过遗传因素起作用。外因外界致癌因素是引起癌症的重要刺激因素，大约80％～90％的癌症是由环境因素引起的。已知致癌因素有化学、物理、生物、营养等几种，较重要的有以下几项：①吸烟与被动吸烟。肺癌病人中吸烟者是不吸烟者的10倍；吸烟者肺癌、喉癌、食管癌、膀胱癌、口咽癌的发病率也比不吸烟者高。吸烟量与癌症发病关系尚不明确，即使接触烟草的烟雾量不大也会发生癌症。近年来还发现，经常生活在嗜烟者烟雾环境中的不吸烟者，发生癌症的机会也多。②职业因素。因长期接触煤焦油、芳香胺或偶氮染料、亚硝胺类化合物等而致的职业性癌，可占全部癌症的2％～8％。职业性癌一般有相当长的潜伏期，发生在皮肤、泌尿道、呼吸道等部位的职业性癌较常见。③放射线及紫外线。电离辐射(X射线、γ射线)所诱发的癌症约占全部癌症的3％，紫外线照射可诱发皮肤癌或恶性黑色素瘤。④膳食。人类的饮食结构和习惯与消化道癌关系密切。膳食中脂肪过多易诱发乳癌、大肠癌；水果和蔬菜可降低大肠癌的发病；有些食品添加剂具有致癌作用；腌、熏食品和一些蔬菜、肉类、火腿、啤酒中可能含有致癌的亚硝酸盐和硝酸盐；含有黄曲霉毒素的食品与肝癌发病可能有关。⑤药物。治疗癌症的各种抗肿瘤药特别是烷化剂，本身也具有致癌作用；此外，某些解热镇痛药、抗癫痫药、抗组胺药、激素类等与癌症的病因有关。⑥寄生虫与病毒。血吸虫病可引起膀胱癌；中华分枝睾吸虫可引起胆管癌。迁延性乙型肝炎所致的肝硬变患者容易发生肝癌；单纯疱疹病毒与宫颈癌的发病有关。许多病毒可以诱发动物肿瘤，但在人类尚缺乏直接证据。
妇科再造制剂由酒当归、醋炙香附、白芍、熟地黄、阿胶、茯苓、党参、黄芪、山药、白术、酒蒸女贞子、醋炙龟甲、山茱萸、续断、盐杜仲、肉苁蓉、覆盆子、鹿角霜、川芎、丹参、牛膝、益母草、延胡索、油酥三七、醋炙艾叶、小茴香、藁本、海螵蛸、醋炙地榆、益智、泽泻、醋炙荷叶、秦艽、地骨皮、白薇、椿皮、琥珀、酒黄芩、酸枣仁、制远志、陈皮、甘草及辅料制成；目前已有资料显示妇科再造制剂具有养血调经，补益肝肾，暖宫止痛功效。用于月经先后不定期，带经日久，淋漓出血，痛经，带下等症。发明人在临床研究中发现，妇科再造制剂还具有一定的治疗肿瘤及其并发症的作用。
发明内容
本发明的目的在于，提供妇科再造制剂在制备预防或治疗肿瘤及其并发症的药物中的应用。
本发明通过以下技术方案实现的：
妇科再造制剂在制备预防或治疗肿瘤及其并发症的药物中的应用。
前述的应用，所述的肿瘤包括妇科肿瘤。
前述的应用中，所述的妇科肿瘤包括外阴癌，阴道癌，宫颈癌，子宫内膜癌，卵巢癌或乳腺癌。
前述的应用中，所述妇科再造制剂按重量份计算，由酒当归60-70份、醋炙香附60-70份、白芍40-50份、熟地黄15-30份、阿胶5-20份、茯苓60-70份、党参15-30份、黄芪15-30份、山药25-40份、白术10-20份、酒蒸女贞子40-50份、醋炙龟甲25-40份、山茱萸15-30份、续断15-30份、盐杜仲15-30份、肉苁蓉5-20份、覆盆子10-20份、鹿角霜2-10份、川芎40-50份、丹参15-30份、牛膝10-20份、益母草15-30份、延胡索10-20份、油酥三七2-10份、醋炙艾叶40-50份、小茴香15-30份、藁本15-30份、海螵蛸25-40份、醋炙地榆25-40份、益智5-20份、泽泻15-30份、醋炙荷叶10-20份、秦艽15-30份、地骨皮15-30份、白薇40-50份、椿皮25-40份、琥珀2-10份、酒黄芩25-40份、酸枣仁5-20份、制远志10-20份、陈皮25-40份、甘草15-30份和辅料制作而成。
前述的应用中，所述的妇科再造制剂按照重量组分计算，由酒当归65.14份、醋炙香附65.14份、白芍43.43份、熟地黄21.71份、阿胶10.86份、茯苓65.14份、党参21.71份、黄芪21.71份、山药32.57份、白术16.28份、酒蒸女贞子43.43份、醋炙龟甲32.57份、山茱萸21.71份、续断21.71份、盐杜仲21.71份、肉苁蓉10.86份、覆盆子16.28份、鹿角霜5.43份、川芎43.43份、丹参21.71份、牛膝16.28份、益母草21.71份、延胡索16.28份、油酥三七5.43份、醋炙艾叶43.43份、小茴香21.71份、藁本21.71份、海螵蛸32.57份、酒炙地榆32.57份、益智10.86份、泽泻21.71份、醋炙荷叶16.28份、秦艽21.71份、地骨皮21.71份、白薇43.43份、椿皮32.57份、琥珀5.43份、酒黄芩32.57份、酸枣仁10.86份、制远志16.28份、陈皮32.57份、甘草21.71份和辅料制作而成。
前述的应用中，所述的妇科再造制剂这样制备：取上述药物，加入一种或多种药学上可以接受的辅料，再按照药学领域的常规方法，制备成医药领域中可接受的剂型。
前述的应用中，所述剂型包括口服制剂、注射制剂或外用制剂。
前述的应用中，所述口服制剂包括胶囊剂、丸剂、颗粒剂、片剂、口服液或糖浆剂。
前述的应用中，所述胶囊剂制备方法为：黄芪、盐杜仲、熟地黄、续断、秦艽、肉苁蓉、牛膝、地骨皮加水煎煮2次，每次2h合并煎煮液，滤过，滤液浓缩；另取阿胶适量水烊化与上述浓缩液合并，浓缩至相对密度为1.10(80℃)的浸膏，其余三十二味粉碎成细粉，过筛，混匀，用上述浸膏与药粉混匀，60-80℃干燥，粉碎成中粉或细粉，装入胶囊，即得。
为了使本领域普通技术人员更好的理解本发明，以下通过实验及实施例来进一步阐述本发明的用途：
实验例1.治疗肿瘤实验研究
1实验材料
1.1实验动物：雄性SD大鼠，8-10周龄，体重180-210g，由贵州医科大学动物中心提供。
1.2主要仪器设备：KDM型控温电热套(山东湮城华鲁仪器公司)；EYELA N-1000旋转蒸发仪(日本EYELA公司)；电热恒温水浴锅(山东龙口市先科仪器公司)；ER-182A电子天平(A&D company)；80-1型离心沉淀器(江苏金坛市正基仪器有限公司)；MDF-382E超低温冰箱(日本SANYO公司)。
1.3药物与试剂：妇科再造制剂(按照实施例1的制备方法进行制备)；二甲基亚砜(DMSO,AR试剂)；3-(4,5-二甲基噻唑-2)-2,5-二苯基四氮唑溴盐(MTT,Sigma试剂)；替加弗(FT-207)；小鼠肉瘤S180细胞(腹水型)、小鼠肝癌细胞H22、小鼠黑色瘤细胞B16-F10、人肝癌细胞HepG-2、艾氏腹水瘤细胞EAC，购自贵阳医学院。
2血清制备
大鼠25只分为5组：阳性对照(FT-207,3ml/kg)组，妇科再造制剂高剂量组(17ml/kg)，妇科再造制剂中剂量组(8.5ml/kg)，妇科再造制剂低剂量组(4.3ml/kg)，阴性对照组(蒸馏水)各5只。每天上、下午灌胃给药两次，共7次。末次给药后1.5h麻醉固定，手术暴露腹主动脉，小心剥离结缔组织，以10ml一次性注射器取血，迅速将血置于洁净玻璃离心管中，静置3h。离心(3500rpm×1h)，取血清。56℃水浴中静置30min灭活，针式滤器(0.22μm)滤过除菌。EP管无菌分装，1ml/管，封口，-20℃冷冻保存。
3MTT法测定妇科再造制剂对肿瘤细胞的抑制作用
肿瘤细胞(S180，H22，EAC,NKM,B16,HepG-2)悬浮液100μl(含2×104个细胞)，加入96孔板中，置37℃5％CO2、饱和水汽细胞培养箱中培养24h；去除含加药血清20μl，培养48h；再加0.5％MTT液15μl，继续培养4h，取出，悬浮细胞2500rmp×30min离心，小心去除上清，加DMSO200μl，置恒温振荡器中振摇10min，使甲臜颗粒溶解，于酶标仪上570nm波长处测光密度(OD)值，并按下式计算各组抑制率：
4统计分析
数据以表示。组间比较用方差分析法，p<0.05有统计学意义，采用SPSS软件进行分析。
5实验结果
由表1～表6可见，妇科再造制剂(8.5ml/kg)可以抑制B16细胞的生长(p＜0.01)，妇科再造制剂(17ml/kg)可以抑制S180和HepG-2细胞的生长(p＜0.01)，妇科再造制剂(17、8.5ml/kg)可以抑制H22和NKM细胞的生长(p＜0.01,p＜0.05)。因此，妇科再造制剂(即含妇科再造制剂的血清)对除EAC细胞外的其他五种细胞(S180，H22，NKM，B16，HepG-2)均有一定程度的抑制作用。
表1 含妇科再造制剂血清对B16细胞的抑制作用(n＝8)
与阴性对照组比较，**p＜0.01
表2 含妇科再造制剂血清对S180细胞的抑制作用(n＝8)
与阴性对照组比较，**p＜0.01
表3 含妇科再造制剂血清对H22细胞的抑制作用(n＝8)
与阴性对照组比较，**p＜0.01
表4 含妇科再造制剂血清对EAC细胞的抑制作用(n＝8)
与阴性对照组比较，*p＜0.05,**p＜0.01
表5 含妇科再造制剂血清对NKM细胞的抑制作用(n＝8)
与阴性对照组比较，*p＜0.05,**p＜0.01
表6 含妇科再造制剂血清对HepG-2细胞的抑制作用(n＝8)
与阴性对照组比较，*p＜0.05，**p＜0.01。
实验例2.治疗乳腺癌实验研究
1材料
1.1实验动物和细胞株
健康雌性BALB/C小鼠40只,体质量18-21g，实验前于本实验室适应1周,饲养条件为:(23±3)℃,相对湿度65％-70％,光暗周期12h/12h,自由摄食、饮水，所有实验在白天进行；4T1细胞株购自中国科学院上海生命科学院细胞资源中心。
1.2实验药物及试剂
本发明妇科再造制剂(按实施例1进行制备)，枸橼酸他莫西芬片(辽宁一成药业有限公司,国药准字:H21023608；注射用环孢素A(北京双鹤药业股份有限公司,国药准字:H20054367；超氧化物歧化酶(Superoxide Dismutase,SOD)检测试剂盒批号20120214,谷光甘肽过氧化物酶(Glutathione Peroxidase,GSH-Px)检测试剂盒批号20120217,丙二醛(Malondialdhyde,MDA)检测试剂盒批号20121109,均购自南京建成生物工程研究所。肿瘤坏死因子α(Tumor Necrosis Factor，TNF-α)检测试剂盒批号ARB13070,购自北京优剂生物科技有限公司。
1.3主要设备
550型酶标仪,BIO公司生产。DMS200型紫外可见分光光度计,美国VARIAN公司生产。1575型洗板机,BIO公司生产。VXH-3微型旋涡混合器,BIO公司生产。MM-1型微型馄合器,BIO公司生产。Sysmex血液分析仪,日本Sysmex公司生产。
2方法
2.1乳腺癌造模与分组给药
先将BALB/c小鼠腹腔注射环孢素A0.2g/d,连续注射8d并同时培养4T1细胞,于第8d将生长良好、密度为lxl06/mL的4T1细胞悬液O.lmL注射于小鼠右前肢腋下。再将BALB/c小鼠按照体质量随机分组,即正常组、模型组、他莫西芬组(他莫西芬4.1mg/kg)、本发明组(妇科再造胶囊药3g/kg)每组10只，4T1细胞接种第2d开始灌胃给药,小鼠每次灌胃剂量为0.4mL/20g,1次/d,连续28d。正常组和模型组灌胃给等量生理盐水。
2.2乳腺癌生长抑制率测定
给药28d后以脱颈椎处死,量称小鼠体质量。仔细剥离乳腺癌组织并称量乳腺癌组织质量,按公式计算小鼠乳腺癌组织生长抑制率。乳腺癌组织生长抑制率(％)＝[(模型对照组平均瘤重-实验组平均瘤重)/模型对照组平均瘤重]X 100％。
2.3脏器指数测定
小鼠处理同2.2方法,量称小鼠体质量并量称小鼠脾脏、胸腺质量,计算小鼠脾脏、胸腺指数。脏器指数＝脏器质量/小鼠体质量><100％。
2.4测定白细胞数
给药28d后,小鼠处死前眼眶取血,用血液分析仪测定白细胞数。
2.5氧化应激指标测定
严格按照试剂盒说明书操作,黄嘌呤氧化酶法测定血清SOD,二硫代二硝基苯甲酸(DTNB)直接法测GSH-Px,硫代巴比妥酸法测MDA活性。
2.6肿瘤坏死因子α水平测定
酶联免疫吸附实验测TNF-a,用酶联免疫检测仪在570nm，波长处测其吸光度OD值,OD值的高低与样品中的TNF-α浓度呈比例关系。
2.8统计学分析
利用SPSS19.0进行统计分析,数据以表示。组间差异采用单因素方差分析,两两比较采用q(Newman-Keuls法)检验，乳腺癌发生率采用Fisher's精确概率法检验,以P<0.05为有统计学意义。
3结果
3.1对4T1细胞乳腺癌小鼠的抑制作用
结果见表7，
表7 对4T1细胞乳腺癌小鼠的抑制作用(n＝10)
注：与正常对照组比较，**p＜0.01；
与模型组比较，+p＜0.05，++p＜0.01。
由表可知，组小鼠给予不同药物干预28d后，发现他莫西芬和本发明妇科再造制剂对4T1细胞乳腺癌小鼠均显示出不同的抑制作用。他莫昔芬组和本发明组小鼠平均瘤重比模型组明显减少，结果表明，本发明妇科再造制剂与他莫西芬对小鼠4T1细胞乳腺癌小鼠具有明显抑制作用。
3.2对4T1细胞乳腺癌小鼠脾指数、胸腺指数和WBC的影响
结果见表8.
表8 对4T1细胞乳腺癌小鼠脾指数、胸腺指数和WBC的影响(n＝10)
注：与正常对照组比较，*p＜0.05；
与模型组比较，+p＜0.05，++p＜0.01。
由表可知，与正常组比较,模型组、他莫西芬组和本发明妇科再造制剂组的WBC数明显升高，他莫西芬组和本发明妇科再造制剂组的WBC数又低于模型组，前者说明小鼠接种4T1细胞后刺激体内产生肿瘤细胞和免疫反应,一定程度激发了WBC的功能,后者说明WBC具有吞噬、参与免疫反应和抗肿瘤细胞的治疗作用；与模型组比较,他莫西芬组和本发明妇科再造制剂能降低小鼠的脾指数和胸腺指数(P<0.05),本发明妇科再造制剂脾指数和胸腺指数下降更为明显，表明本发明妇科再造制剂能够降低免疫器官的质量。
3.3对4T1细胞乳腺癌小鼠血清SOD、GSH-Px、MDA、TNF-α含量的影响
结果见表9.
表9 对4T1细胞乳腺癌小鼠血清SOD、GSH-Px、MDA、TNF-α含量的影响(n＝10)
注：与正常对照组比较，*p＜0.05；
与模型组比较，+p＜0.05，++p＜0.01。
由表可知，与正常对照组比较模型组GSH-P活性明显降低，他莫西芬组和本发明组GSH-Px活性高于模型组，与正常对照组比较,模型组SOD活性降低与模型组比较,他莫西芬组和本发明组活性上升，模型组MDA活性较正常对照组上升，他莫西芬组和本发明组MDA活性较模型组降低；他莫西芬组和本发明组TNF-α浓度较模型组降低。
与现有技术相比，本发明所述妇科再造制剂制剂能治疗肿瘤及其并发症。其治疗肿瘤及其并发症的作用可能与其在一定程度上抑制肿瘤细胞S180，H22，NKM，B16，HepG-2，本发明妇科再造制剂还能在一定程度上治疗妇科肿瘤，特别是治疗乳腺癌。
具体实施方式
实施例1：
处方：酒当归65.14g、醋炙香附65.14g、白芍43.43g、熟地黄21.71g、阿胶10.86g、茯苓65.14g、党参21.71g、黄芪21.71g、山药32.57g、白术16.28g、酒蒸女贞子43.43g、醋炙龟甲32.57g、山茱萸21.71g、续断21.71g、盐杜仲21.71g、肉苁蓉10.86g、覆盆子16.28g、鹿角霜5.43g、川芎43.43g、丹参21.71g、牛膝16.28g、益母草21.71g、延胡索16.28g、油酥三七5.43g、醋炙艾叶43.43g、小茴香21.71g、藁本21.71g、海螵蛸32.57g、酒炙地榆32.57g、益智10.86g、泽泻21.71g、醋炙荷叶16.28g、秦艽21.71g、地骨皮21.71g、白薇43.43g、椿皮32.57g、琥珀5.43g、酒黄芩32.57g、酸枣仁10.86g、制远志16.28g、陈皮32.57g、甘草21.71g和辅料。
工艺：黄芪、盐杜仲、熟地黄、续断、秦艽、肉苁蓉、牛膝、地骨皮加水煎煮2次，每次2h合并煎煮液，滤过，滤液浓缩；另取阿胶适量水烊化与上述浓缩液合并，浓缩至相对密度为1.10(80℃)的浸膏，其余三十二味粉碎成细粉，过筛，混匀，用上述浸膏与药粉混匀，60-80℃干燥，粉碎成中粉或细粉，装入胶囊，即得。
规格：0.41g/粒。
用法用量：口服，一次6粒，一日2次。一个月经周期为一个疗程，经前一周开始服用。
功能与主治：治疗肿瘤，包括外阴癌，阴道癌，宫颈癌，子宫内膜癌，卵巢癌、乳腺癌等。

Claims (9)

1.妇科再造制剂在制备预防或治疗肿瘤及其并发症的药物中的应用。
2.如权利要求1所述的应用，其特征在于：所述的肿瘤包括妇科肿瘤。
3.如权利要求1所述的应用，其特征在于：所述的妇科肿瘤包括外阴癌，阴道癌，宫颈癌，子宫内膜癌，卵巢癌或乳腺癌。
4.如权利要求1所述的应用，其特征在于：所述妇科再造制剂按重量份计算，由酒当归60-70份、醋炙香附60-70份、白芍40-50份、熟地黄15-30份、阿胶5-20份、茯苓60-70份、党参15-30份、黄芪15-30份、山药25-40份、白术10-20份、酒蒸女贞子40-50份、醋炙龟甲25-40份、山茱萸15-30份、续断15-30份、盐杜仲15-30份、肉苁蓉5-20份、覆盆子10-20份、鹿角霜2-10份、川芎40-50份、丹参15-30份、牛膝10-20份、益母草15-30份、延胡索10-20份、油酥三七2-10份、醋炙艾叶40-50份、小茴香15-30份、藁本15-30份、海螵蛸25-40份、醋炙地榆25-40份、益智5-20份、泽泻15-30份、醋炙荷叶10-20份、秦艽15-30份、地骨皮15-30份、白薇40-50份、椿皮25-40份、琥珀2-10份、酒黄芩25-40份、酸枣仁5-20份、制远志10-20份、陈皮25-40份、甘草15-30份和辅料制作而成。
5.如权利要求4所述的应用，其特征在于：所述的妇科再造制剂按照重量组分计算，由酒当归65.14份、醋炙香附65.14份、白芍43.43份、熟地黄21.71份、阿胶10.86份、茯苓65.14份、党参21.71份、黄芪21.71份、山药32.57份、白术16.28份、酒蒸女贞子43.43份、醋炙龟甲32.57份、山茱萸21.71份、续断21.71份、盐杜仲21.71份、肉苁蓉10.86份、覆盆子16.28份、鹿角霜5.43份、川芎43.43份、丹参21.71份、牛膝16.28份、益母草21.71份、延胡索16.28份、油酥三七5.43份、醋炙艾叶43.43份、小茴香21.71份、藁本21.71份、海螵蛸32.57份、酒炙地榆32.57份、益智10.86份、泽泻21.71份、醋炙荷叶16.28份、秦艽21.71份、地骨皮21.71份、白薇43.43份、椿皮32.57份、琥珀5.43份、酒黄芩32.57份、酸枣仁10.86份、制远志16.28份、陈皮32.57份、甘草21.71份和辅料制作而成。
6.如权利要求5所述的应用，其特征在于：所述的妇科再造制剂这样制备：取上述药物，加入一种或多种药学上可以接受的辅料，再按照药学领域的常规方法，制备成医药领域中可接受的剂型。
7.如权利要求6所述的应用，其特征在于：所述剂型包括口服制剂、注射制剂或外用制剂。
8.如权利要求7所述的应用，其特征在于：所述口服制剂包括胶囊剂、丸剂、颗粒剂、片剂、口服液或糖浆剂。
9.如权利要求8所述的应用，其特征在于：所述胶囊剂制备方法为：黄芪、盐杜仲、熟地黄、续断、秦艽、肉苁蓉、牛膝、地骨皮加水煎煮2次，每次2h合并煎煮液，滤过，滤液浓缩；另取阿胶适量水烊化与上述浓缩液合并，浓缩至相对密度为1.10(80℃)的浸膏，其余三十二味粉碎成细粉，过筛，混匀，用上述浸膏与药粉混匀，60-80℃干燥，粉碎成中粉或细粉，装入胶囊，即得。
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