CN113633733B - 一种妇科再造丸的制备方法 - Google Patents
一种妇科再造丸的制备方法 Download PDFInfo
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- CN113633733B CN113633733B CN202110483050.XA CN202110483050A CN113633733B CN 113633733 B CN113633733 B CN 113633733B CN 202110483050 A CN202110483050 A CN 202110483050A CN 113633733 B CN113633733 B CN 113633733B
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Abstract
本发明公开了一种妇科再造丸的制备方法。包括有以下步骤:(1)膏粉混合物:按妇科再造丸标准处方制得膏粉混合物;(2)黏合剂的制备:取甘油于容器中,加入可药用的羧甲基纤维素盐,搅匀,密封,加热至羧甲基纤维素盐完全溶胀,制得黏合剂,备用;(3)丸剂的制备:在膏粉混合物中加入占制成药物总量25‑50%比例的黏合剂,混合均匀,制丸,即得。本发明具有不干燥,不包衣,使用的黏合剂成分符合药典标准,并且无毒副作用,安全性高,制得的丸剂容散时限低,使制丸过程更加的简便,减少制备工序,提高成品率,质量稳定、可控的有益效果。
Description
技术领域
本发明涉及一种妇科再造丸,特别是一种妇科再造丸(柔性丸)的制备方法。
背景技术
妇科再造丸,为养血调经、补肝益肾、暖宫止痛用药,用于月经先后不定期,带经日久,淋漓出血,痛经,带下等症。妇科再造丸其组方出自名医王聘贤之手,由酒当归、醋香附、白芍、熟地黄、阿胶、茯苓等42味药材组成,集调经、消炎、暖宫、止痛、养血、补气、疏肝、健脾、补肾九大功效于一身;既能治疗各类妇科病症,又能通过系统调理,提高身体素质,增强机体免疫力,祛斑养颜、延缓衰老。妇科再造丸已有百年历史,是贵阳德昌祥药业有限公司的独家产品,执行标准为国药药品标准,编号为:WS-10051(ZD-0051)-2002-2012Z。【处方】酒当归、醋香附、白芍、熟地黄、阿胶、茯苓、党参、黄苠、山药、等42味药材组成【制法】按照组方取黄芩、盐杜仲、熟地黄、等水煎煮两次,每次两小时,合并煎液,滤过,滤液浓缩;另取阿胶加适量水烊化与上述浓缩液合并,浓缩至相对密度为1.10(80℃)的清膏。其余当归等三十三味粉碎成细粉,过筛,混匀;用上述清膏泛丸,制成浓缩丸1000g,60-80℃干燥,包糖衣,打光,即得。
由于妇科再造丸为浓缩丸,其中处方中生粉量为清膏量的5.7倍,膏量少,生粉量大,在制丸过程中需要加水才能制丸,而且粘性小,难以成型,成型丸子在干燥过程中容易开裂,这些难题导致妇科再造丸成品率低;而且在药品的储存过程中,本来外观完整的丸子也会开裂,导致产品的外观不符合规定,影响产品质量。在生产过程中通过增加炼药次数、降低干燥温度等,开裂的难题依然不能得到解决。
发明内容
本发明的目的在于,提供一种妇科再造丸的制备方法。本发明具有不干燥,不包衣,使用的黏合剂成分符合药典标准,并且无毒副作用,安全性高,制得的丸剂容散时限低,使制丸过程更加的简便,减少制备工序,提高成品率,质量稳定、可控的特点。
本发明的技术方案:一种妇科再造丸的制备方法,所述妇科再造丸的药用有效成分为:酒当归65.14份、醋香附66.14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、洒炙地榆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;所述丸剂的制备方法包括下述步骤:
(1)膏粉混合物的制备:取黄芩、盐杜仲、熟地黄、续断、秦艽、肉苁蓉、牛膝、地骨皮加水煎煮,合并煎液,滤过,滤液浓缩;另取阿胶加适量水烊化与上述浓缩液合并,浓缩至清膏;其余当归等三十三味粉碎成细粉,过100目筛,将上述清膏和细粉混匀,得膏粉混合物;
(2)黏合剂的制备:取甘油于容器中,加入可药用的羧甲基纤维素盐,搅匀,密封,至羧甲基纤维素盐完全溶胀,制得黏合剂,备用;
(3)丸剂的制备:在膏粉混合物中加入占制成药物总量20-50%比例的黏合剂,混合均匀,制丸,即得。
所述膏粉混合物这样制备:取黄芩、盐杜仲、熟地黄、续断、秦艽、肉苁蓉、牛膝、地骨皮加水煎煮两次,每次两小时,合并煎液,滤过,滤液浓缩;另取阿胶加适量水烊化与上述浓缩液合并,浓缩至80℃时相对密度为1.10的清膏;其余当归等三十三味粉碎成细粉,过100目筛,将上述清膏和细粉混匀,即得。
所述可药用的羧甲基纤维素盐包括:羧甲基纤维素钠或羧甲基纤维素钙。
前述的妇科再造丸的制备方法中,所述步骤(2)中,按重量比,甘油:可药用的羧甲基纤维素盐=100:1-15。
具体地说,按重量比,甘油:可药用的羧甲基纤维素盐=100:2.5-10。
更具体地说,按重量比,甘油:可药用的羧甲基纤维素盐=100:2.5-7.66。
步骤(2)中,所述加热的条件是60-105℃下加热4-10小时,每间隔0.5-2 小时搅拌一次。最佳加热条件是85-105℃下加热5-7小时,
步骤(3)中,所述黏合剂加入的比例为制成药物总量的25-45%。
具体地说,所述黏合剂加入的比例为制成药物总量的30-40%。
与现有技术相比,本发明具有以下有益效果:
本发明具有不干燥,不包衣,使用的黏合剂成分符合药典标准,并且无毒副作用,安全性高,制得的丸剂容散时限低,使制丸过程更加的简便,减少制备工序,提高成品率,质量稳定、可控的有益效果。
申请人就本发明所述制备柔性丸的制备技术应用于妇科再造丸、儿童回春丸、六味地黄丸、杞菊地黄丸、苏合香丸、知柏地黄丸,均取得到了显著的效果。以下是妇科再造丸-柔性丸的相关试验证明。发明人做了大量试验,部分试验记录如下:
【制法】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2小时,合并煎液,滤过,滤液浓缩;另取阿胶加适量水烊化与上述浓缩液合并,浓缩至相对密度为1.10(80℃)的清膏。其余当归等三十三味粉碎成细粉,过筛,混匀;将清膏和细粉分别均匀分为两份备用。
妇科再造丸浓缩丸(以下简称浓缩丸):取其中一份清膏和细粉,用清膏泛丸,制成浓缩丸,60~80℃干燥,包糖衣,打光,即得。(备注:由于清膏量小,需要在制丸过程中加水)
妇科再造丸-柔性丸:取另一份清膏和细粉,将清膏和细粉混合均匀,备用。
黏合剂制备:取100.04g甘油于烧杯中,加入4.04g羧甲基纤维素钠,搅拌均匀,于90℃的环境下加热7小时,制成黏合剂备用。
取60.01g混合物,加入32.02g的黏合剂,混合均匀,制成柔性丸剂。
【性状】
浓缩丸:见图1:本品为糖衣浓缩丸,除去糖衣显棕黄色至棕褐色,味微苦、略麻。
柔性丸:见图2:本品为棕褐色,微有弹性,味微苦、略麻。
结论:二者外观不一致,浓缩丸有糖衣,而本发明的柔性丸不进行包衣,浓缩丸素丸和本发明的柔性丸外观相似,但是本发明改进后的柔性丸微有弹性。
【鉴别】
1、α-香附酮
浓缩丸供试品的制备:取本品15.07,研细,加石油醚(60~90℃)50ml,加热回流40分钟,滤过,滤液挥干,残渣加乙酸乙酯1ml使溶解,即得。
专利丸剂供试品制备:取本品15.17,加适量硅藻土研细,加石油醚(60~ 90℃)50ml,加热回流40分钟,滤过,滤液挥干,残渣加乙酸乙酯1ml使溶解,即得。
对照品的制备:另取α-香附酮对照品,加乙酸乙酯制成每1ml含1mg的溶液,即得。
温度:6℃;湿度:75%;
对照品名称:α-香附酮,来源:中国食品药品检定研究院;
批号:110748-201513;配制批号:20200618-01;
展开剂:环己烷-乙酸乙酯(9:1);
固定相:羧甲基纤维素钠为黏合剂的硅胶G;
供试品点样量:10μl;对照品点样量:2μl。
显色剂:二硝基苯肼试液(配制批号:20201021),放置片刻,在日光下检视。
供试品色谱中,在与对照品色谱相应的位置上,显橙色的斑点。薄层图见图 3,图3中从左到右依次为妇科再造丸浓缩丸、α-香附酮对照品、妇科再造丸柔性丸。
结论:妇科再造丸浓缩丸及本发明的柔性丸均能检验出α-香附酮。
2、芍药苷
浓缩丸供试品的制备:取本品15.00g,研细,加甲醇50ml,加热回流45 分钟,放冷,滤过,滤液蒸干,残渣加水30ml使溶解,用乙醚振摇提取2次,每次20ml,弃去醚液,用水饱和的正丁醇振摇提取3次,每次25ml,合并正丁醇液,再用正丁醇饱和的水洗3次,每次20ml,合并正丁醇液,蒸干,残渣加甲醇1ml使溶解,加中性氧化铝2g,在水浴上拌匀,干燥,装入中性氧化铝柱 (100~200目,2g,内径10mm,干法装柱)上,用乙酸乙酯-甲醇(1:1)40ml 洗脱,收集洗脱液,蒸干,残渣加乙醇1ml使溶解,即得。
柔性丸供试品的制备:取本品15.18g,加适量硅藻土研细,制法同浓缩丸。
对照品的制备:另取芍药苷对照品,加乙醇制成每1ml含1mg的溶液,即得。
温度:6℃;湿度:75%;
对照品名称:芍药苷,来源:中国食品药品检定研究院;
批号:110736-201943;配制批号:20201103;
展开剂:三氯甲烷-乙酸乙酯-甲醇-甲酸(40:5:10:0.2)。
固定相:羧甲基纤维素钠为黏合剂的硅胶G
供试品点样量:10μl;对照品点样量:10μl;
显色剂:5%香草醛硫酸溶液(配制批号:20200820),在105℃加热至斑点显色清晰,在日光下检视。
供试品色谱中,在与对照品色谱相应的位置上,显蓝紫色的斑点。薄层图见图4,图4中从左到右依次为妇科再造丸浓缩丸、芍药苷对照品、妇科再造丸柔性丸、妇科再造丸柔性丸;
结论:妇科再造丸浓缩丸及本发明的柔性丸均能检验出芍药苷。
3、黄芩苷
浓缩丸供试品的制备:取本品15.01g,研细,加乙醚50ml,加热回流30 分钟,滤过,弃去醚液。药渣挥去乙醚,加甲醇50ml,加热回流45分钟,滤过,滤液蒸干,残渣加水25ml使溶解,滤过,滤液用盐酸调pH值至2,用乙酸乙酯振摇提取2次,每次20ml,合并乙酸乙酯液,蒸干,残渣加甲醇1ml使溶解,即得。
柔性丸剂供试品制备:取本品15.47g,加适量硅藻土研细,制法同上。
对照品的制备:另取黄芩苷对照品,加甲醇制成每1ml含1mg的溶液,即得。
温度:5℃;湿度:75%;
对照品名称:黄芩苷,来源:中国食品药品检定研究院;
批号:110715-201821;配制批号:20201103;
展开剂:乙酸乙酯-丁酮-甲酸-水(5:3:1:1);
固定相:含4%醋酸钠的羧甲基纤维素钠溶液为黏合剂的硅胶G;
供试品点样量:10μl;对照品点样量:10μl;
显色剂:5%三氯化铁乙醇溶液(配制批号:20201103),在日光下检视。
供试品色谱中,在与对照品色谱相应的位置上,显浅棕色的斑点。薄层图见图5,图5中从左到右依次为妇科再造丸浓缩丸、黄芩苷对照品、妇科再造丸柔性丸。
结论:妇科再造丸浓缩丸及本发明的柔性丸均能检验出黄芩苷。
4、橙皮苷
供试品的制备:取【鉴别】(4)项下的供试品溶液作为供试品溶液。
对照品的制备:取橙皮苷对照品,加甲醇制成饱和溶液,即得。
温度:4℃;湿度:72%;
对照品名称:橙皮苷,来源:中国食品药品检定研究院;
批号:110721-201818;配制批号:J20200720-01;
展开剂:三氯甲烷-甲醇-水(32:17:5)的下层溶液;
配制批号:20201104;
固定相:1%氢氧化钠的羧甲基纤维素钠溶液为黏合剂的硅胶G
供试品点样量:10μl;对照品点样量:10μl;
显色剂:三氯化铝试液(配制批号:20200909),置紫外光灯(365nm) 下检视。
仪器名称:ZF-20D紫外分析仪;仪器编号:QC046;
供试品色谱中,在与对照品色谱相应的位置上,显浅绿色的荧光斑点。薄层图见图6,图6中从左到右依次为妇科再造丸浓缩丸、橙皮苷对照品、妇科再造丸柔性丸。
结论:妇科再造丸浓缩丸及本发明的柔性丸均能检验出橙皮苷成分。
5、丹参酮ⅡA
浓缩丸供试品制备:取本品24.81g,研细,加乙醚80ml,超声处理30分钟,滤过,滤液挥干,残渣加乙酸乙酯2ml使溶解,作为供试品溶液。
专利丸剂供试品的制备:取本品25.39g,加适量硅藻土研细,制法同上。
对照品制备:取丹参丹参酮ⅡA对照品,加乙酸乙酯制成每1ml含1mg的溶液,即得。
温度:3℃;湿度:71%;
对照品名称:丹参酮ⅡA,来源:中国食品药品检定研究院;
批号:110766-201520;配制批号:20201211;
展开剂:苯—乙酸乙酯(19:1);
配制批号:20201211;
固定相:硅胶G;
供试品点样量:20μl;对照品点样量:5μl;
显色剂:无,日光下检视。
仪器名称:ZF-20D紫外分析仪;仪器编号:QC046;
供试品色谱中,在与对照品色谱相应的位置上,显浅粉色的斑点。薄层图见图7,图7中从左到右依次为妇科再造丸浓缩丸、丹参酮ⅡA对照品、妇科再造丸柔性丸。
结论:妇科再造丸浓缩丸及本发明的柔性丸均能检验出丹参酮ⅡA成分。
6、黄芪药材、黄芪甲苷
浓缩丸供试品制备:取本品24.98g,研细,加水饱和正丁醇80ml,超声处理30分钟,滤过,滤液加氨试液振摇提取2次,每次25ml,弃去氨液,正丁醇液再以正丁醇饱和水洗涤2次,每次25ml,弃去水液,正丁醇液蒸干,残渣加甲醇2ml使溶解,作为供试品溶液。
专利丸剂供试品制备:取本品24.80g,加适量硅藻土研细,其余制法同上。
对照药材溶液制备:取黄芪对照药材,同发制成对照药材溶液,即得。
对照品溶液制备:取黄芪甲苷对照品,加甲醇制成每1ml含1mg的溶液,作为对照品溶液,即得。
温度:4℃;湿度:72%;
对照品名称:黄芪甲苷,来源:中国食品药品检定研究院;
批号:110781-201314;配制批号:20201211;
对照药材名称:黄芪,来源:中国食品药品检定研究院;
批号:120974-201813;
展开剂:三氯甲烷-甲醇-水(13:7:2)的下层溶液;
配制批号:20201211;
固定相:硅胶G;
供试品点样量:20μl;对照品点样量:5μl;
显色剂:10%硫酸乙醇溶液(配制批号:20200901),在105℃加热至斑点显色清晰,置紫外光灯(365nm)下检视。
仪器名称:ZF-20D紫外分析仪;仪器编号:QC046;
供试品色谱中,在与对照药材、对照品色谱相应的位置上,显的荧光斑点。薄层图见图8和图9,图8为日光下的薄层图,图9为紫外光灯 (365nm)下的薄层图;图8中中从左到右依次为妇科再造丸浓缩丸、黄芪甲苷、黄芪对照药材、妇科再造丸柔性丸;图9中中从左到右依次为妇科再造丸浓缩丸、黄芪甲苷、黄芪对照药材、妇科再造丸柔性丸。
结论:妇科再造丸浓缩丸及本发明的柔性丸均能检验出黄芪药材和黄芪甲苷成分。
【检查】
1、水分:不得过9%。
烘干法(妇科再造丸浓缩丸)
温度:4℃;湿度:72%;
干燥温度:105℃;干燥时间:7小时;
称量瓶(第一次,g)65.3432;称量瓶(恒重,g)65.3432;
称样量(g):3.998;1
称量瓶+样(第一次,g)69.3413;称量瓶+样(第二次,g)69.3407;
计算过程:
((65.3432+3.9981)-69.3407)/3.9981*100%=7.34%
甲苯法(本发明的柔性丸)
样品取样量:44.4405g;
甲苯量:200ml;
水分刻度读数:2.8ml;
计算过程:
2.8/44.4405*100%=6.30%
结论:本发明未进行干燥工艺的柔性丸水分比妇科再造丸浓缩丸水分更低,满足标准。
2、溶散时限:应在2小时内完全溶解。(妇科再造丸浓缩丸)
水温:37.0℃
崩解溶剂:水
崩解完全时间:102min
溶散时限:应在2小时内完全溶解。(本发明的柔性丸)
温度:37.0℃
崩解溶剂:水
崩解完全时间:18min
结论:本发明柔性丸的崩解时间远远短于妇科再造丸浓缩丸,浓缩丸崩解时间较长,柔性丸的工艺大大缩短了崩解时间,具体见图10。
含量测定:
照高效液相色谱法(中国药典2010年版一部附录ⅥD)测定。
温度:25℃;湿度:65%;
色谱柱:规格:4.6mm*250mm
流速:1ml/min;柱温:30℃
对照品名称:芍药苷,来源:中国食品药品检定研究院
芍药苷对照品批号:110736-201943;对照溶液配制批号:20201125
色谱条件与系统适用性试验:以氰基键合硅胶为填充剂;以甲醇-水(11:89) 为流动相,测波长为230nm。理论板数按芍药苷峰计算应不低于4000。
对照品溶液的制备:取芍药苷对照品10mg,精密称定,置20ml量瓶中,加甲醇溶解并稀释至刻度,摇匀,精密量取1ml,置20ml量瓶中,加甲醇至刻度,摇匀,即得。
浓缩丸供试品溶液的制备:取本品适量,除去糖衣,研细,取约1g,精密称定,置具塞锥形瓶中,精密加入50%甲醇25ml,密塞,称定重量,超声处理 (功率250W,频率35kHz)1小时,放冷,再称定重量,用50%甲醇补足减失的重量,摇匀,滤过,精密量取续滤液10ml,置水浴上挥至约0.5ml,再用甲醇溶解,移至10ml量瓶中,加甲醇至刻度,摇匀,滤过,取续滤液,即得。
专利丸剂供试品溶液制备:取本品1g,加入适量的硅藻土研细均匀,转移至具塞锥形瓶中,其余制法同浓缩丸。
测定法分别精密吸取对照品溶液与供试品溶液10μl,注入液相色谱仪,测定,即得。
本品每1g含白芍以芍药苷(C23H28O11)mg计,不得少于0.30mg。
芍药苷称样量:10.41mg
浓度:10.41mg*0.951/50ml*4ml/25ml=0.03168mg/ml
对照品峰面积①:501548 对照品峰面积②:504968
对照品峰面积③:505040 对照品峰面积④:518070
对照品峰面积⑤:521936
稀释倍数:25
浓缩丸丸重:=0.26g
柔性丸丸重:=0.42g
浓缩丸称样量①:1.1813g;柔性丸剂称样量①:0.9989g
浓缩丸称样量②:1.1473g;柔性丸剂称样量②:1.0861g
浓缩丸峰面积①:3126321.5;柔性丸剂峰面积①:162645
浓缩丸峰面积②:309136.5;柔性丸剂峰面积②:189065.5
计算过程:
结论:对比本发明改变工艺后的妇科再造丸柔性丸与传统工艺的妇科再造丸浓缩丸,指标成分含量无明显变化,工艺的变更和丸剂外观变化对于质量没有影响。
芍药苷对照品的色谱图见图11-图15:图11是本发明试验证明-检查中含量测定芍药苷对照品①的色谱图;图12是本发明试验证明-检查中含量测定芍药苷对照品②的色谱图;图13是本发明试验证明-检查中含量测定芍药苷对照品③的色谱图;图14是本发明试验证明-检查中含量测定芍药苷对照品④的色谱图;图 15是本发明试验证明-检查中含量测定芍药苷对照品⑤的色谱图。
浓缩丸样的色谱图见图16-18:图16是本发明试验证明-检查中含量测定妇科再造丸浓缩丸①的色谱图;图17是本发明试验证明-检查中含量测定妇科再造丸浓缩丸①的色谱图;图18是本发明试验证明-检查中含量测定妇科再造丸浓缩丸②的色谱图。
本发明的柔性丸样的色谱图见图19-22:图19是本发明试验证明-检查中含量测定妇科再造丸柔性丸①的色谱图;图20是本发明试验证明-检查中含量测定妇科再造丸柔性丸①的色谱图;图21是本发明试验证明-检查中含量测定妇科再造丸柔性丸②的色谱图;图22是本发明试验证明-检查中含量测定妇科再造丸柔性丸②的色谱图。
现有妇科再造丸浓缩丸和本发明的妇科再造丸柔性丸优势比较:
1、现有妇科再造丸浓缩丸易开裂,在素丸制丸、干燥、保存过程中均会出现开裂现象,开裂现象不仅影响妇科丸生产过程的成品率,同时影响妇科再造丸的保存和效期,影响产品形象及市场。
(1)现有妇科再造丸浓缩丸制丸过程中开裂主要是因为妇科丸煎煮药材较少,膏量少,药材细粉多,泛丸过程困难,需要加水才能制丸,因此粘性较低,药丸易开裂,见图23。
(2)现有妇科再造丸浓缩丸的干燥工序中开裂:由于制丸过程中加水,为了控制丸剂的水分,水分较大,干燥时间较长,易开裂,见图24。
(3)现有妇科再造丸浓缩丸的保存过程中易开裂:妇科再造丸干燥后丸子本身较脆,包衣后随着保存时间的延长,水分丢失或者吸水,都会导致丸剂发生不均匀收缩或者胀大,致使丸子包衣开裂,见图25。
(4)现有妇科再造丸浓缩丸丸子本身硬度较大,硬度测试为6.96kg,见图 26。
2、本发明的妇科再造丸柔性丸的优点:
(1)本发明的妇科再造丸柔性丸有效改善妇科再造丸开裂情况,保证在制丸、存放过程中不产生开裂现象,见图27。
(2)本发明的妇科再造丸柔性丸过程中使用不加水的黏合剂,减少生产过程中干燥工序,也能保证水分合格,且水分比原工艺水分低,更能有效控制水分,保证产品质量,节约工时,提高效率并降低成本。(见上述内容中水分测定试验)
(3)本发明的妇科再造丸柔性丸具有更有利于崩解,崩解时限比浓缩丸时间更短。(见崩解试验:柔性丸完全崩解时间18min,浓缩丸完全崩解时间 102min。)
(4)本发明的妇科再造丸柔性丸具有一定的柔性和弹性,且经过放置一段时间后任然具有弹性,见图28和29,本发明的妇科再造丸柔性丸刚制丸完成时的硬度测试为2.09kg,室内常温下放置一个月的硬度测试为2.31kg。
综上所述,本发明所述柔性丸具有不干燥,不包衣,使用的黏合剂成分符合药典标准,并且无毒副作用,安全性高,制得的丸剂容散时限低,使制丸过程更加的简便,减少制备工序,提高成品率,质量稳定、可控的有益效果。
附图说明
图1是本发明试验证明-性状中浓缩丸(现有的妇科再造丸浓缩丸)的实物图;
图2是本发明试验证明-性状中柔性丸(本发明的妇科再造丸柔性丸)的实物图;
图3是本发明试验证明-鉴别中α-香附酮的薄层图,其中从左到右依次为妇科再造丸浓缩丸、α-香附酮对照品、妇科再造丸柔性丸;
图4是本发明试验证明-鉴别中芍药苷的薄层图,其中从左到右依次为妇科再造丸浓缩丸、芍药苷对照品、妇科再造丸柔性丸、妇科再造丸柔性丸;
图5是本发明试验证明-鉴别中黄芩苷的薄层图,其中从左到右依次为妇科再造丸浓缩丸、黄芩苷对照品、妇科再造丸柔性丸;
图6是本发明试验证明-鉴别中橙皮苷的薄层图,其中从左到右依次为妇科再造丸浓缩丸、橙皮苷对照品、妇科再造丸柔性丸;
图7是本发明试验证明-鉴别中丹参酮ⅡA的薄层图,其中从左到右依次为妇科再造丸浓缩丸、丹参酮ⅡA对照品、妇科再造丸柔性丸;
图8是本发明试验证明-鉴别中黄芪甲苷、黄芪对照药材日光下的薄层图,其中从左到右依次为妇科再造丸浓缩丸、黄芪甲苷、黄芪对照药材、妇科再造丸柔性丸;
图9是本发明试验证明-鉴别中黄芪甲苷、黄芪对照药材紫外光灯(365nm) 下的薄层图,其中从左到右依次为妇科再造丸浓缩丸、黄芪甲苷、黄芪对照药材、妇科再造丸柔性丸;
图10是本发明试验证明-检查中妇科再造丸浓缩丸和妇科再造丸柔性丸的崩解试验图;
图11是本发明试验证明-检查中含量测定芍药苷对照品①的色谱图;
图12是本发明试验证明-检查中含量测定芍药苷对照品②的色谱图;
图13是本发明试验证明-检查中含量测定芍药苷对照品③的色谱图;
图14是本发明试验证明-检查中含量测定芍药苷对照品④的色谱图;
图15是本发明试验证明-检查中含量测定芍药苷对照品⑤的色谱图;
图16是本发明试验证明-检查中含量测定妇科再造丸浓缩丸①的色谱图;
图17是本发明试验证明-检查中含量测定妇科再造丸浓缩丸①的色谱图;
图18是本发明试验证明-检查中含量测定妇科再造丸浓缩丸②的色谱图;
图19是本发明试验证明-检查中含量测定妇科再造丸柔性丸①的色谱图;
图20是本发明试验证明-检查中含量测定妇科再造丸柔性丸①的色谱图;
图21是本发明试验证明-检查中含量测定妇科再造丸柔性丸②的色谱图;
图22是本发明试验证明-检查中含量测定妇科再造丸柔性丸②的色谱图;
图23是本发明试验证明-优势比较中妇科再造丸浓缩丸制丸过程的实物图;
图24是本发明试验证明-优势比较中妇科再造丸浓缩丸干燥过程的实物图;
图25是本发明试验证明-优势比较中妇科再造丸浓缩丸保存过程中的实物图;
图26是本发明试验证明-优势比较中妇科再造丸浓缩丸的硬度测试图;
图27是本发明试验证明-优势比较中妇科再造丸柔性丸的实物图;
图28是本发明试验证明-优势比较中妇科再造丸柔性丸刚制丸完成时的硬度测试图;
图29是本发明试验证明-优势比较中妇科再造丸柔性丸放置一个月的硬度测试图。
具体实施方式
下面结合附图和实施例对本发明作进一步的说明,但并不作为对本发明限制的依据。
实施例1。一种妇科再造丸的制备方法,包括有以下步骤:
(1)膏粉混合物:称取酒当归65.14g、醋香附66.14g、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、洒炙地榆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,取黄芩、盐杜仲、熟地黄、续断、秦艽、肉苁蓉、牛膝、地骨皮加水煎煮两次,每次两小时,合并煎液,滤过,滤液浓缩,得浓缩液;另取阿胶加适量水烊化与上述浓缩液合并,浓缩至80℃下相对密度为1.10的清膏,其余三十三味粉碎,过100目筛,得细粉,将上述清膏和细粉混匀,得膏粉混合物;
(2)黏合剂:取100g的甘油于容器中,加入4g的羧甲基纤维素钠,搅拌均匀,密封,将容器置于90℃的环境下加热5-6小时至羧甲基纤维素钠完全溶胀,每间隔1.5小时进行搅拌一次,制得黏合剂备用;
(3)妇科再造丸-柔性丸:在膏粉混合物中加入占制成药物总量34%比例的黏合剂,混合均匀,制丸,即得。
实施例2。一种妇科再造丸的制备方法,包括有以下步骤:
(1)按照实施例1所述方法制备膏粉混合物;
(2)黏合剂:取100g的甘油于容器中,加入1g的羧甲基纤维素钠,搅拌均匀,密封,将容器置于85℃的环境下加热6-7小时至羧甲基纤维素钠完全溶胀,每间隔2小时进行搅拌一次,制得黏合剂备用;
(3)妇科再造丸-柔性丸:在膏粉混合物中加入占制成药物总量20%比例的黏合剂,混合均匀,制丸,即得。
实施例3。一种妇科再造丸的制备方法,包括有以下步骤:
(1)按照实施例1所述方法制备膏粉混合物;
(2)黏合剂:取100g的甘油于容器中,加入15g的羧甲基纤维素钠,搅拌均匀,密封,将容器置于105℃的环境下加热4-5小时至羧甲基纤维素钠完全溶胀,每间隔0.5小时进行搅拌一次,制得黏合剂备用;
(3)妇科再造丸-柔性丸:在膏粉混合物中加入占制成药物总量50%比例的黏合剂,混合均匀,制丸,即得。
实施例4。一种妇科再造丸的制备方法,包括有以下步骤:
(1)按照实施例1所述方法制备膏粉混合物;
(2)黏合剂:取100g的甘油于容器中,加入2.5g的羧甲基纤维素钙,搅拌均匀,密封,将容器置于90℃的环境下加热6-7小时至羧甲基纤维素钙完全溶胀,每间隔1小时进行搅拌一次,制得黏合剂备用;
(3)妇科再造丸-柔性丸:在膏粉混合物中加入占制成药物总量40%比例的黏合剂,混合均匀,制丸,即得。
实施例5。一种妇科再造丸的制备方法,包括有以下步骤:
(1)按照实施例1所述方法制备膏粉混合物;
(2)黏合剂:取100g的甘油于容器中,加入10g的羧甲基纤维素钙,搅拌均匀,密封,将容器置于100℃的环境下加热4-6小时至羧甲基纤维素钙完全溶胀,每间隔1.5小时进行搅拌一次,制得黏合剂备用;
(3)妇科再造丸-柔性丸:在膏粉混合物中加入占制成药物总量30%比例的黏合剂,混合均匀,制丸,即得。
实施例6。一种妇科再造丸的制备方法,包括有以下步骤:
(1)按照实施例1所述方法制备膏粉混合物;
(2)黏合剂:取100g的甘油于容器中,加入5g的羧甲基纤维素钙,搅拌均匀,密封,将容器置于60℃的环境下加热9-10小时至羧甲基纤维素钙完全溶胀,每间隔1.5小时进行搅拌一次,制得黏合剂备用;
(3)妇科再造丸-柔性丸:在膏粉混合物中加入占制成药物总量45%比例的黏合剂,混合均匀,制丸,即得。
实施例7。一种妇科再造丸的制备方法,包括有以下步骤:
(1)按照实施例1所述方法制备膏粉混合物;
(2)黏合剂:取100g的甘油于容器中,加入6g的羧甲基纤维素钠,搅拌均匀,密封,将容器置于105℃的环境下加热4-5小时至羧甲基纤维素钠完全溶胀,每间隔1.5小时进行搅拌一次,制得黏合剂备用;
(3)妇科再造丸-柔性丸:在膏粉混合物中加入占制成药物总量30%比例的黏合剂,混合均匀,制丸,即得。
Claims (1)
1.一种妇科再造丸的制备方法,其特征在于:所述妇科再造丸的药用有效成分按重量份计算为:酒当归65.14份、醋香附66.14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、洒炙地榆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;所述丸剂的制备方法包括下述步骤:
(1)膏粉混合物的 制备:取黄芩、盐杜仲、熟地黄、续断、秦艽、肉苁蓉、牛膝、地骨皮加水煎煮两次,每次两小时,合并煎液,滤过,滤液浓缩;另取阿胶加适量水烊化与上述浓缩液合并,浓缩至80℃时相对密度为1.10的清膏;其余三十三味粉碎成细粉,过100目筛,将上述清膏和细粉混匀,即得;
(2)黏合剂的制备:取100.04g甘油于烧杯中,加入4.04g羧甲基纤维素钠,搅拌均匀,于90℃的环境下加热7小时,制成黏合剂备用;
(3)丸剂的制备:在60.01g混合物,加入32.02g的黏合剂,混合均匀,制成柔性丸剂。
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