CN110339277A - 妇科止带片及其制备方法 - Google Patents
妇科止带片及其制备方法 Download PDFInfo
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- CN110339277A CN110339277A CN201910770116.6A CN201910770116A CN110339277A CN 110339277 A CN110339277 A CN 110339277A CN 201910770116 A CN201910770116 A CN 201910770116A CN 110339277 A CN110339277 A CN 110339277A
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Abstract
发明公开了一种妇科止带片及其制备方法,其原料主要由以下重量份的组分组成:椿皮363份、五味子64份、黄柏363份、龟板242份、茯苓363份、阿胶120份、山药363份。该制备方法将组方中黄柏、茯苓、五味子和山药等药味先经醇提水沉除杂后,药渣再与椿皮经水提醇沉除杂,保证了有效成分的提取完全,同时能有效去除杂质,提高了提取物中有效成分的含量,保证了产品的疗效。该发明产品克服了普通片剂、胶囊剂存在的崩解及起效较慢,溶出度低,生物利用度较低等问题,具有崩解速度快,溶出较好,吸收较快,作用起效快,生物利用度高,不良反应少,服用方便等优点。
Description
技术领域
本发明涉及药品领域,具体涉及一种妇科止带片及其制备方法。
背景技术
分散片(Dispersible tablets)又称水分散片(Water dispersible tablets),系指遇水可迅速崩解形成均匀粘性混悬液的片剂。相对于普通片剂来说,分散片可增加难溶性药物的溶解,吸收快,生物利用度高,不良反应小,能够降低药物对胃肠道的刺激性。分散片服用方便,可吞服、咀嚼、含吮,也可置水中分散后单独服用或与果汁、牛奶同服,尤其适合老、幼和吞服固体困难的患者。
妇科止带片处方收载于《中国药典》2015版,该方主要包括椿皮、五味子、黄柏、龟板、茯苓、阿胶、山药等7味药材,具清热燥湿,收敛止带之功效,用于湿热带下、阴痒等病,症见带下赤白,或黄白如脓,粘稠有味,或***瘙痒、疼痛、舌苔薄黄、脉搏多滑等。妇科止带片原有制备工艺为:方中药味椿皮加水煎煮,煎液醇沉,静置,滤过,滤过,回收乙醇并浓缩成相对密度1.38(80℃)的稠膏;黄柏用8倍量85%乙醇回流提取,滤过,滤液回收乙醇并浓缩成相对密度1.38(80℃)的稠膏;茯苓用60%乙醇、五味子、山药用45%乙醇进行渗漉,收集渗漉液,回收乙醇并浓缩成相对密度1.38(80℃)的稠膏;龟板用水浸洗除去肉屑,加水煎煮,滤过,滤液浓缩成稠膏,滤渣晾干,粉碎成粗粉,用3倍量10%醋酸溶液浸渍,滤过,滤液蒸干;阿胶用蛤粉炒后粉碎成细粉,过筛,与上述各稠膏及醋酸浸出物混匀,加微晶纤维素、羟丙基纤维素、羧甲基淀粉钠适量,制成颗粒,干燥,加入1%的硬脂酸镁、2%的滑石粉,混匀,压制成1000片,包薄膜衣,即得。妇科止带片对于慢性子***,子***、***粘膜炎等引起的湿热型赤白带症的治疗效果较好。由于原有制备工艺中药材提取杂质成分较多,需经除去一定的杂质才能满足分散片制备时中药提取物杂质尽量少的要求,因此,必须改进提取工艺。
发明内容
本发明的目的在于针对原妇科止带片制剂工艺的不足,进行合理的改革,提供一种药效好的妇科止带片及其制备方法。
本发明所采用的技术方案如下:
一种妇科止带片,其原料主要由以下重量份的组分组成:椿皮363份、五味子64份、黄柏363份、龟板242份、茯苓363份、阿胶120份、山药363份,其制备方法包括以下步骤:
R1.分别取椿皮、五味子、黄柏、龟板、茯苓、阿胶、山药,净选,干燥;
R2.按以下重量份称取组分:椿皮363份、五味子64份、黄柏363份、龟板242份、茯苓363份、阿胶120份、山药363份;
R3.制备药材提取物干膏粉;
R4.分别取交联聚乙烯吡咯烷酮、低取代羟丙基纤维素、微粉硅胶,粉碎过120目筛,备用;
R5.按以下重量份称取组分:取交联聚乙烯吡咯烷酮10份、低取代羟丙基纤维素10份、微粉硅胶1份;
R6.取药材提取物干膏粉、交联聚乙烯吡咯烷酮、低取代羟丙基纤维素加入搅拌机中,搅拌均匀后加入80%乙醇溶液,搅拌均匀后制成软材,过20目制粒,干燥,取出,50目筛整粒,得干颗粒;
R7.取步骤R7的干颗粒,加微粉硅胶混合均匀,压片,即得。
进一步的,以上所述的妇科止带片,其制备方法步骤R3制备药材提取物干膏粉的方法为:
S1.取黄柏、茯苓、五味子和山药,加乙醇回流提取,滤过,药渣备用,滤液浓缩至在60℃时相对密度为1.10~1.15的清膏,加4~6倍量水,搅拌均匀,静置24-48h,滤取上清液,浓缩至稠膏,减压干燥,粉碎,过100目筛,备用;
S2.取椿皮和S1的药渣,加水煎煮,滤过,滤液浓缩至60℃时相对密度为1.10~1.15的清膏,加乙醇使含醇量约为50%,静置24-48h,滤取上清液,回收乙醇并浓缩成稠膏,干燥,粉碎,过100目筛,备用;
S3.取龟板用水浸洗除去肉屑,加30倍量水煎煮二次,每次6小时,合并煎液,滤过,滤液浓缩成在80℃时相对密度为1.38胶状稠膏;滤渣晾干,粉碎成粗粉,用3倍量10%醋酸溶液浸渍,滤过,滤液蒸干,粉碎,过100目筛,备用;
S4.阿胶用蛤粉炒后粉碎成细粉,过100目筛,备用;
S5.取上述各细粉,混合,得干膏粉。
更进一步的,以上所述的妇科止带片,步骤S1所述加乙醇溶液回流提取为加8~12倍量70%乙醇回流提取2~3次,每次1~2小时。
更进一步的,以上所述的妇科止带片,步骤S2加水煎煮为加6-10倍量水煎煮2~3次,每次1-2小时。
一种如上所述的妇科止带片的制备方法,包括以下步骤:
R1.分别取椿皮、五味子、黄柏、龟板、茯苓、阿胶、山药,净选,干燥;
R2.按以下重量份称取组分:椿皮363份、五味子64份、黄柏363份、龟板242份、茯苓363份、阿胶120份、山药363份;
R3.制备药材提取物干膏粉;
R4.分别取交联聚乙烯吡咯烷酮、低取代羟丙基纤维素、微粉硅胶,粉碎过120目筛,备用;
R5.按以下重量份称取组分:取交联聚乙烯吡咯烷酮10份、低取代羟丙基纤维素10份、微粉硅胶1份;
R6.取药材提取物干膏粉、交联聚乙烯吡咯烷酮、低取代羟丙基纤维素加入搅拌机中,搅拌均匀后加入80%乙醇溶液,搅拌均匀后制成软材,过20目制粒,干燥,取出,50目筛整粒,得干颗粒;
R7.取步骤R7的干颗粒,加微粉硅胶混合均匀,压片,即得。
进一步的,以上所述的妇科止带片,其特征在于,其制备方法步骤R3制备药材提取物干膏粉的方法为:
S1.取黄柏、茯苓、五味子和山药,加乙醇回流提取,滤过,药渣备用,滤液浓缩至在60℃时相对密度为1.10~1.15的清膏,加4~6倍量水,搅拌均匀,静置24-48h,滤取上清液,浓缩至稠膏,减压干燥,粉碎,过100目筛,备用;
S2.取椿皮和S1的药渣,加水煎煮,滤过,滤液浓缩至60℃时相对密度为1.10~1.15的清膏,加乙醇使含醇量约为50%,静置24-48h,滤取上清液,回收乙醇并浓缩成稠膏,干燥,粉碎,过100目筛,备用;
S3.取龟板用水浸洗除去肉屑,加30倍量水煎煮二次,每次6小时,合并煎液,滤过,滤液浓缩成在80℃时相对密度为1.38胶状稠膏;滤渣晾干,粉碎成粗粉,用3倍量10%醋酸溶液浸渍,滤过,滤液蒸干,粉碎,过100目筛,备用;
S4.阿胶用蛤粉炒后粉碎成细粉,过100目筛,备用;
S5.取上述各细粉,混合,得干膏粉。
更进一步的,以上所述的妇科止带片,步骤S1所述加乙醇溶液回流提取为加8~12倍量70%乙醇回流提取2~3次,每次1~2小时。
更进一步的,以上所述的妇科止带片,步骤S2加水煎煮为加6-10倍量水煎煮2~3次,每次1-2小时。
本发明的有益效果是:
1.本发明将组方中黄柏、茯苓、五味子和山药等药味先经醇提水沉除杂后,药渣再与椿皮经水提醇沉除杂,保证了有效成分的提取完全,同时能有效去除杂质,提高了提取物中有效成分的含量,保证了产品的疗效,经临床试验结果表明,本发明产品在治疗慢性子***,子***、***粘膜炎等引起的湿热型赤白带症的总有效率达95.0%以上,明显高于传统制备方法生产的妇科止带片。
2.本发明制剂克服了普通片剂、胶囊剂存在的崩解及起效较慢,溶出度低,生物利用度较低等问题,具有崩解速度快,溶出较好,吸收较快,作用起效快,生物利用度高,不良反应少,服用方便等优点。
具体实施方式
下面结合具体实施例对本发明作进一步描述,但不限制本发明的保护范围和应用范围:
一、提取工艺的研究
根据方中药味有效部位的化学性质,尝试了对方中黄柏、茯苓、五味子、山药等药味先醇提再水提,再对提取物进行除杂。对比了以下几种方法。
1.原工艺路线
取椿皮加8倍量水煎煮二次,每次2小时,合并煎液,滤过,滤液浓缩至相对密度1.20(60℃)的清膏,加乙醇使含醇量约为50%,静置,滤过。黄柏用8倍量85%乙醇回流提取三次,每次1.5小时,合并提取液,滤过。茯苓用60%乙醇、五味子、山药用45%乙醇照流浸膏与浸膏剂项下的渗漉法进行渗漉。收集茯苓10倍量渗漉液,五味子、山药8倍量渗漉液。以上各液分别回收乙醇并浓缩成相对密度1.38(80℃)的稠膏。
2.本发明方法
取黄柏、茯苓、五味子和山药,加10倍量70%乙醇回流提取2次,每次2小时滤过,药渣备用,滤液浓缩至在60℃时相对密度为1.12的清膏,加5倍量水,搅拌均匀,静置36h,滤取上清液;取椿皮和前述药渣,加8倍量水煎煮2次,每次2小时,滤过,滤液浓缩至60℃时相对密度为1.12的清膏,加乙醇使含醇量约为50%,静置36h,滤取上清液,回收乙醇后与前述上清液混合并浓缩成稠膏。
测定上述稠膏的得膏率、黄柏总生物碱含量,结果见表1。
表1 不同提取方法的提取结果
由表1可知,两种方法所得提取物的黄柏总生物碱含量相当,但是方法2提取物的得膏率低于方法1的,说明方法2能除去部分杂质。
在以上对比实验的基础上,还对乙醇溶液的浓度进行了筛选试验,利用方法2,对比了60%、70%、80%三种不同浓度的乙醇溶液回流提取的结果,见表2。
表2 不同浓度乙醇溶液的提取结果
由表2可知,70%乙醇和80%乙醇回流提取得膏率与黄柏总生物碱含量相当,出于成本的考虑,选择70%乙醇回流提取。
二、制剂条件筛选
1.崩解剂的选择
崩解剂的种类及用量对分散片的崩解、溶出效果至关重要。选择分散片中常用的羧甲基淀粉钠(CMS-Na)、低取代羟丙基纤维素(L-HPC)、交联羧甲纤维素钠(cCMC-Na)、交联聚乙烯吡咯烷酮(PVPP)作为崩解剂进行比较,以崩解时限、分散均匀性和外观为评价指标进行综合评价,以确定分散片中最佳的崩解剂种类。结果见表3。
表3 崩解剂的选择试验结果表
从表3中的试验结果可知:以PVPP、L-HPC为崩解剂制得的片剂表面光滑,且崩解时限和分散均匀性均较好,故本发明选择PVPP、L-HPC联用为崩解剂,采用内加法加入。
2.粘合剂的选择
试验中考察了5%聚乙烯吡喏烷酮K30(PVPK30)水溶液、10%聚乙烯吡喏烷酮K30(PVPK30)乙醇溶液、80%乙醇溶液做粘合剂,以制粒情况、片剂成形、崩解时限为评价指标进行综合评价,结果见表4。
表4 粘合剂考察结果表
由表4中可知:使用80%乙醇溶液作粘合剂时,制粒情况、片剂成形和崩解时限均较好,故本发明粘合剂选择80%乙醇溶液。
3.助流剂的选择
试验中对比了1%微粉硅胶、1%硬脂酸镁、1%硬脂酸镁-微粉硅胶(1∶1),结果以1%微粉硅胶作为助流剂时效果最好,故本发明选用1%微粉硅胶做为助流剂。
三、妇科止带片的制备方法
实施例1
R1.分别取椿皮、五味子、黄柏、龟板、茯苓、阿胶、山药,净选,干燥;
R2.按以下重量份称取组分:椿皮363g、五味子64g、黄柏363g、龟板242g、茯苓363g、阿胶120g、山药363g;
R3.制备药材提取物干膏粉:取黄柏、茯苓、五味子和山药,加70%乙醇回流提取3次,第一次加12倍量回流提取2小时,第二次加10倍量回流提取1.5小时,第三次加8倍量回流提取1小时,合并滤液,滤过,药渣备用,滤液浓缩至在60℃时相对密度为1.10的清膏,加4倍量水,搅拌均匀,静置24小时,滤取上清液,浓缩至稠膏,减压干燥,粉碎,过100目筛,备用;取椿皮和乙醇溶液回流提取后的药渣,加水煎煮2次,第一次加10倍量水煎煮2小时,第二次加8倍量水煎煮1小时,合并水煎煮,滤过,滤液浓缩至60℃时相对密度为1.15的清膏,加乙醇使含醇量约为50%,静置48小时,滤取上清液,回收乙醇并浓缩成稠膏,干燥,粉碎,过100目筛,备用;取龟板用水浸洗除去肉屑,加30倍量水煎煮二次,每次6小时,合并煎液,滤过,滤液浓缩成在80℃时相对密度为1.38胶状稠膏;滤渣晾干,粉碎成粗粉,用3倍量10%醋酸溶液浸渍,滤过,滤液蒸干,粉碎,过100目筛,备用;阿胶用蛤粉炒后粉碎成细粉,过100目筛,备用;取各细粉,混合,得干膏粉;
R4.分别取交联聚乙烯吡咯烷酮、低取代羟丙基纤维素、微粉硅胶,粉碎过120目筛,备用;
R5.按以下重量份称取组分:取交联聚乙烯吡咯烷酮(PVPP)10g、低取代羟丙基纤维素(L-HPC)10g、微粉硅胶1g;
R6.取药材提取物干膏粉、交联聚乙烯吡咯烷酮、低取代羟丙基纤维素加入搅拌机中,搅拌均匀后加入80%乙醇溶液,搅拌均匀后制成软材,过20目制粒,干燥,取出,50目筛整粒,得干颗粒;
R7.取步骤R7的干颗粒,加微粉硅胶混合均匀,压片,即得。
实施例2
R1.分别取椿皮、五味子、黄柏、龟板、茯苓、阿胶、山药,净选,干燥;
R2.按以下重量份称取组分:椿皮363g、五味子64g、黄柏363g、龟板242g、茯苓363g、阿胶120g、山药363g;
R3.制备药材提取物干膏粉:取黄柏、茯苓、五味子和山药,加10倍量70%乙醇回流提取2次,每次2小时,合并滤液,滤过,药渣备用,滤液浓缩至在60℃时相对密度为1.15的清膏,加6倍量水,搅拌均匀,静置48小时,滤取上清液,浓缩至稠膏,减压干燥,粉碎,过100目筛,备用;取椿皮和乙醇溶液回流提取后的药渣,加水煎煮3次,第一次加12倍量水煎煮2小时,第二次加8倍量水煎煮1.5小时,第二次加6倍量水煎煮1小时,合并水煎煮,滤过,滤液浓缩至60℃时相对密度为1.15的清膏,加乙醇使含醇量约为50%,静置48小时,滤取上清液,回收乙醇并浓缩成稠膏,干燥,粉碎,过100目筛,备用;取龟板用水浸洗除去肉屑,加30倍量水煎煮二次,每次6小时,合并煎液,滤过,滤液浓缩成在80℃时相对密度为1.38胶状稠膏;滤渣晾干,粉碎成粗粉,用3倍量10%醋酸溶液浸渍,滤过,滤液蒸干,粉碎,过100目筛,备用;阿胶用蛤粉炒后粉碎成细粉,过100目筛,备用;取各细粉,混合,得干膏粉;
R4.分别取交联聚乙烯吡咯烷酮、低取代羟丙基纤维素、微粉硅胶,粉碎过120目筛,备用;
R5.按以下重量份称取组分:取交联聚乙烯吡咯烷酮(PVPP)10g、低取代羟丙基纤维素(L-HPC)10g、微粉硅胶1g;
R6.取药材提取物干膏粉、交联聚乙烯吡咯烷酮、低取代羟丙基纤维素加入搅拌机中,搅拌均匀后加入80%乙醇溶液,搅拌均匀后制成软材,过20目制粒,干燥,取出,50目筛整粒,得干颗粒;
R7.取步骤R7的干颗粒,加微粉硅胶混合均匀,压片,即得。
实施例3
R1.分别取椿皮、五味子、黄柏、龟板、茯苓、阿胶、山药,净选,干燥;
R2.按以下重量份称取组分:椿皮363g、五味子64g、黄柏363g、龟板242g、茯苓363g、阿胶120g、山药363g;
R3.制备药材提取物干膏粉:取黄柏、茯苓、五味子和山药,加10倍量70%乙醇回流提取3次,每次1.5小时,合并滤液,滤过,药渣备用,滤液浓缩至在60℃时相对密度为1.2的清膏,加5倍量水,搅拌均匀,静置36小时,滤取上清液,浓缩至稠膏,减压干燥,粉碎,过100目筛,备用;取椿皮和乙醇溶液回流提取后的药渣,加8倍量水煎煮3次,每次1.5小时,合并水煎煮,滤过,滤液浓缩至60℃时相对密度为1.13的清膏,加乙醇使含醇量约为50%,静置36小时,滤取上清液,回收乙醇并浓缩成稠膏,干燥,粉碎,过100目筛,备用;取龟板用水浸洗除去肉屑,加30倍量水煎煮二次,每次6小时,合并煎液,滤过,滤液浓缩成在80℃时相对密度为1.38胶状稠膏;滤渣晾干,粉碎成粗粉,用3倍量10%醋酸溶液浸渍,滤过,滤液蒸干,粉碎,过100目筛,备用;阿胶用蛤粉炒后粉碎成细粉,过100目筛,备用;取各细粉,混合,得干膏粉;
R4.分别取交联聚乙烯吡咯烷酮、低取代羟丙基纤维素、微粉硅胶,粉碎过120目筛,备用;
R5.按以下重量份称取组分:取交联聚乙烯吡咯烷酮(PVPP)10g、低取代羟丙基纤维素(L-HPC)10g、微粉硅胶1g;
R6.取药材提取物干膏粉、交联聚乙烯吡咯烷酮、低取代羟丙基纤维素加入搅拌机中,搅拌均匀后加入80%乙醇溶液,搅拌均匀后制成软材,过20目制粒,干燥,取出,50目筛整粒,得干颗粒;
R7.取步骤R7的干颗粒,加微粉硅胶混合均匀,压片,即得。
四、妇科止带片的质量评价
1.测定崩解时限
采用中国药典2015年版“崩解时限检查法”(通则0921),取实施例1-3样品以及市售妇科止带片(薄膜衣片)进行检测,分别记录崩解时限,结果见表5。
表5 崩解时限测定情况
由表5中可知,本发明妇科止带片及市妇科止带片片(薄膜衣片)崩解时限明显缩短,表明其吸收较快,能快速起效,有利于提高疗效。
2.测定溶出度
采用中国药典2015年版“溶出度与释放度测定法”第一法(通则0931),取实施例1-3的样品以及市售妇科止带片(薄膜衣片)进行检测,采用高效液相色谱法测定盐酸小檗碱的含量,然后计算溶出度,结果见表6。
表6 溶出度测定情况
从表6中可以看出,本发明妇科止带片比市售妇科止带片(薄膜衣片)溶出度明显提高,表明其生物利用度较高。
五、临床试验
1.资料与方法
1.1临床资料
选取86例慢性子***,子***、***粘膜炎引起的湿热型赤白带症患者,表现症状为白带过多、腰骶部酸胀疼痛及下腹部坠胀痛者;部分伴有***出血、淋漓不尽等。将上述患者随机分成试验组和对照组,每组43例。试验组患者,年龄23~47岁,平均(33.52±3.04)岁,病程1~4年,平均(2.48±0.85)年;观察组患者,年龄24~46岁,平均(34.05±3.15)岁,病程1~3年,平均(2.14±0.52)年,两组患者进行对比,无明显差异(P>0.05),具有统计学分析的意义。
以上患者均排除合并存在严重脏器疾病患者以及妊娠期和哺乳期的患者。
1.2治疗方法
试验组采用本发明实施例3样品治疗,口服,一次4片,一日3次,10天为一疗程。对照组采用市售妇科止带片,口服,一次4~6片,一日3次,10天为一疗程。
1.3疗效评价
一个疗程后观察两组治疗效果以及不良反应情况。疗效评价标准为:
(1)痊愈:***不规则出血或经后淋漓不尽,下腹部坠胀、腰骶部胀痛等症状消失,白带正常,月经恢复正常周期;
(2)显效:上述症状减轻,白带逐步减少,月经恢复正常周期;
(3)无效:上述症状有所减轻,但月经仍未恢复正常周期。
1.4统计学处理
采用SPSS 22.0统计软件进行数据处理和分析,,同时采用t检验,当P<0.05时,表明差异有统计学意义。
2.结果
2.1不良反应和安全性评价
治疗过程中,两组患者均未出现不良反应。
2.2临床疗效比较
结果见表7。
表7 两组临床疗效比较(例)
3.结论
以上临床试验结果表明,经本发明制备方法生产的实施例3样品在治疗慢性子***,子***、***粘膜炎等引起的湿热型赤白带症效果上优于传统方法生产的市售妇科止带片,说明其提高了有效性,且服用安全可靠,无不良反应副作用。
Claims (8)
1.一种妇科止带片,其原料主要由以下重量份的组分组成:椿皮363份、五味子64份、黄柏363份、龟板242份、茯苓363份、阿胶120份、山药363份,其特征在于,其制备方法包括以下步骤:
R1.分别取椿皮、五味子、黄柏、龟板、茯苓、阿胶、山药,净选,干燥;
R2.按以下重量份称取组分:椿皮363份、五味子64份、黄柏363份、龟板242份、茯苓363份、阿胶120份、山药363份;
R3.制备药材提取物干膏粉;
R4.分别取交联聚乙烯吡咯烷酮、低取代羟丙基纤维素、微粉硅胶,粉碎过120目筛,备用;
R5.按以下重量份称取组分:取交联聚乙烯吡咯烷酮10份、低取代羟丙基纤维素10份、微粉硅胶1份;
R6.取药材提取物干膏粉、交联聚乙烯吡咯烷酮、低取代羟丙基纤维素加入搅拌机中,搅拌均匀后加入80%乙醇溶液,搅拌均匀后制成软材,过20目制粒,干燥,取出,50目筛整粒,得干颗粒;
R7.取步骤R7的干颗粒,加微粉硅胶混合均匀,压片,即得。
2.根据权利要求1所述的妇科止带片,其特征在于,其制备方法步骤R3制备药材提取物干膏粉的方法为:
S1.取黄柏、茯苓、五味子和山药,加乙醇回流提取,滤过,药渣备用,滤液浓缩至在60℃时相对密度为1.10~1.15的清膏,加4~6倍量水,搅拌均匀,静置24-48h,滤取上清液,浓缩至稠膏,减压干燥,粉碎,过100目筛,备用;
S2.取椿皮和S1的药渣,加水煎煮,滤过,滤液浓缩至60℃时相对密度为1.10~1.15的清膏,加乙醇使含醇量约为50%,静置24-48h,滤取上清液,回收乙醇并浓缩成稠膏,干燥,粉碎,过100目筛,备用;
S3.取龟板用水浸洗除去肉屑,加30倍量水煎煮二次,每次6小时,合并煎液,滤过,滤液浓缩成在80℃时相对密度为1.38胶状稠膏;滤渣晾干,粉碎成粗粉,用3倍量10%醋酸溶液浸渍,滤过,滤液蒸干,粉碎,过100目筛,备用;
S4.阿胶用蛤粉炒后粉碎成细粉,过100目筛,备用;
S5.取上述各细粉,混合,得干膏粉。
3.根据权利要求2所述的妇科止带片,其特征在于,步骤S1所述加乙醇溶液回流提取为加8~12倍量70%乙醇回流提取2~3次,每次1~2小时。
4.根据权利要求2所述的妇科止带片,其特征在于,步骤S2加水煎煮为加6-10倍量水煎煮2~3次,每次1-2小时。
5.一种如权利要求1所述的妇科止带片的制备方法,其特征在于,包括以下步骤:
R1.分别取椿皮、五味子、黄柏、龟板、茯苓、阿胶、山药,净选,干燥;
R2.按以下重量份称取组分:椿皮363份、五味子64份、黄柏363份、龟板242份、茯苓363份、阿胶120份、山药363份;
R3.制备药材提取物干膏粉;
R4.分别取交联聚乙烯吡咯烷酮、低取代羟丙基纤维素、微粉硅胶,粉碎过120目筛,备用;
R5.按以下重量份称取组分:取交联聚乙烯吡咯烷酮10份、低取代羟丙基纤维素10份、微粉硅胶1份;
R6.取药材提取物干膏粉、交联聚乙烯吡咯烷酮、低取代羟丙基纤维素加入搅拌机中,搅拌均匀后加入80%乙醇溶液,搅拌均匀后制成软材,过20目制粒,干燥,取出,50目筛整粒,得干颗粒;
R7.取步骤R7的干颗粒,加微粉硅胶混合均匀,压片,即得。
6.根据权利要求5所述的妇科止带片,其特征在于,其制备方法步骤R3制备药材提取物干膏粉的方法为:
S1.取黄柏、茯苓、五味子和山药,加乙醇回流提取,滤过,药渣备用,滤液浓缩至在60℃时相对密度为1.10~1.15的清膏,加4~6倍量水,搅拌均匀,静置24-48h,滤取上清液,浓缩至稠膏,减压干燥,粉碎,过100目筛,备用;
S2.取椿皮和S1的药渣,加水煎煮,滤过,滤液浓缩至60℃时相对密度为1.10~1.15的清膏,加乙醇使含醇量约为50%,静置24-48h,滤取上清液,回收乙醇并浓缩成稠膏,干燥,粉碎,过100目筛,备用;
S3.取龟板用水浸洗除去肉屑,加30倍量水煎煮二次,每次6小时,合并煎液,滤过,滤液浓缩成在80℃时相对密度为1.38胶状稠膏;滤渣晾干,粉碎成粗粉,用3倍量10%醋酸溶液浸渍,滤过,滤液蒸干,粉碎,过100目筛,备用;
S4.阿胶用蛤粉炒后粉碎成细粉,过100目筛,备用;
S5.取上述各细粉,混合,得干膏粉。
7.根据权利要求5所述的妇科止带片,其特征在于,步骤S1所述加乙醇溶液回流提取为加8~12倍量70%乙醇回流提取2~3次,每次1~2小时。
8.根据权利要求5所述的妇科止带片,其特征在于,步骤S2加水煎煮为加6-10倍量水煎煮2~3次,每次1-2小时。
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