CN104258259A - 孕康胶囊的制备方法 - Google Patents

孕康胶囊的制备方法 Download PDF

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CN104258259A
CN104258259A CN201410538185.1A CN201410538185A CN104258259A CN 104258259 A CN104258259 A CN 104258259A CN 201410538185 A CN201410538185 A CN 201410538185A CN 104258259 A CN104258259 A CN 104258259A
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梁延波
刘声伟
邱振海
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Chaohu C-Dragon Pharmacy Co Ltdof Shanghai Haihong Industrial Co Ltd
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Chaohu C-Dragon Pharmacy Co Ltdof Shanghai Haihong Industrial Co Ltd
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Abstract

本发明公开了一种孕康胶囊的制备方法,将山药、续断、黄芪等二十二味中药材按下述步骤加工:步骤一、将上述原料药用50~60℃温水浸泡后过滤,滤液备用;步骤二、将步骤一过滤后的药渣加水煎煮后过滤,滤液备用;步骤三、合并步骤一和步骤二获得的滤液,加入原料药阿胶,浓缩制成稠膏;步骤四、醇沉步骤三获得的稠膏,取上清液并浓缩制成精制稠膏;步骤五、将步骤四获得的精制稠膏减压干燥制成干膏粉;步骤六、向步骤五获得的干膏粉中加入硬脂酸镁、淀粉浆,混匀后填充即得。本发明所述的孕康胶囊的制备方法能够保证新剂型可以实现原有孕康糖浆的功效,满足实际生产要求和消费需求。

Description

孕康胶囊的制备方法
技术领域
本发明涉及一种孕康胶囊的制备方法,属于医药产品生产制造技术领域。
背景技术
孕康糖浆是一种公知的健脾固肾、养血安胎的药物,主要用于治疗肾虚型和气血虚弱型先兆流产和习惯性流产。众所周知,中药糖浆制剂因含糖等营养成分,在制备和贮藏过程中极易被微生物污染,导致糖浆霉败变质;为防止霉败现象的发生,生产中除需要采取防止污染措施外,常加入适宜的防腐剂以阻止或延缓微生物的增殖,使糖浆质量符合卫生学要求。由此可知,孕康糖浆其制剂形式导致其保质期较短,且发生霉败变质的风险较高。
胶囊制剂是一种非常常见的药物制剂形式,其具有提高药物的稳定性的效果,因药物装在胶囊壳中与外界隔离,避开了水分、空气、光线的影响,对具有不良嗅味、不稳定的药物有一定程度的遮蔽、保护与稳定作用。由于传统的孕康糖浆其制剂中含有水份,会使胶囊壁溶解的液体药剂,因此无法直接制成胶囊制剂,而对于孕康糖浆中的原料改变加工工艺则难以保证新剂型可以实现原有孕康糖浆的功效。
发明内容
本发明正是针对现有技术存在的不足,提供一种孕康胶囊的制备方法,可以实现原有孕康糖浆的功效,满足实际生产要求和消费需求。
为解决上述问题,本发明所采取的技术方案如下:
一种孕康胶囊的制备方法,由以下各质量份的原料药按下述方法制成:山药150份,续断90份,黄芪120份,当归90份,狗脊120份,菟丝子90份,桑寄生60份,杜仲90份,补骨脂90份,党参90份,茯苓120份,白术90份,阿胶30份,地黄120份,山茱萸90份,枸杞子120份,乌梅60份,白芍90份,砂仁60份,益智60份,苎麻根90份,黄芩60份,艾叶10份;
步骤一、将上述原料药除阿胶外,其余均用50~60℃温水浸泡后过滤,滤液备用;
步骤二、将步骤一过滤后的药渣加水煎煮后过滤,滤液备用;
步骤三、合并步骤一和步骤二获得的滤液,加入上述原料药阿胶,浓缩制成稠膏;
步骤四、醇沉步骤三获得的稠膏,取上清液并浓缩制成精制稠膏;
步骤五、将步骤四获得的精制稠膏减压干燥制成干膏粉;
步骤六、向步骤五获得的干膏粉中加入硬脂酸镁、淀粉浆,混匀后填充即得。
作为上述技术方案的改进,在上述步骤一中,除阿胶外的原料药用50~60℃温水浸泡4小时,且水量为用于浸泡的原料药总质量的5倍。
作为上述技术方案的改进,在上述步骤二中,将步骤一过滤后的药渣加水煎煮3次,每次加水量为用于煎煮的药渣质量的4倍,3次煎煮时间分别为2小时、1小时和0.5小时,过滤并合并滤液。
作为上述技术方案的改进,所述步骤六中,用于混合的干膏粉、淀粉浆和硬脂酸镁的质量份数依次为:100份、5~10份和0.05~0.5份。
本发明与现有技术相比较,本发明的实施效果如下:
本发明所述的孕康胶囊的制备方法,为孕康糖浆提供了新的应用剂型,使药物在胶囊壳中与外界隔离,避开了水分、空气、光线的影响,对具有不良嗅味、不稳定的药物有一定程度的遮蔽、保护与稳定作用;且本发明提供的胶囊制备方法能够保证新剂型可以实现原有孕康糖浆的功效,满足实际生产要求和消费需求。
具体实施方式
下面将结合具体的实施例来说明本发明的内容。
具体实施例1
本具体实施所提供的孕康胶囊的制备方法,由以下各质量份的原料药按下述方法制成:山药150份,续断90份,黄芪120份,当归90份,狗脊120份,菟丝子90份,桑寄生60份,杜仲90份,补骨脂90份,党参90份,茯苓120份,白术90份,阿胶30份,地黄120份,山茱萸90份,枸杞子120份,乌梅60份,白芍90份,砂仁60份,益智60份,苎麻根90份,黄芩60份,艾叶10份;
步骤一、将上述原料药除阿胶外,其余均用50~60℃温水浸泡4小时,且水量为用于浸泡的原料药总质量的5倍,浸泡后过滤,滤液备用;
步骤二、将步骤一过滤后的药渣加水煎煮并过滤3次,每次加水量为用于煎煮的药渣质量的4倍,3次煎煮时间分别为2小时、1小时和0.5小时,合并滤液备用;
步骤三、合并步骤一和步骤二获得的滤液,加入上述原料药阿胶,浓缩制成稠膏;
步骤四、醇沉步骤三获得的稠膏,取上清液并浓缩制成精制稠膏;
步骤五、将步骤四获得的精制稠膏减压干燥制成干膏粉;
步骤六、取步骤五获得的干膏粉100克,加入淀粉浆8克、硬脂酸镁0.2克,混匀后填充制得胶囊。
对照实施例1
本具体实施所提供的孕康胶囊的制备方法,由以下各质量份的原料药按下述方法制成:山药150份,续断90份,黄芪120份,当归90份,狗脊120份,菟丝子90份,桑寄生60份,杜仲90份,补骨脂90份,党参90份,茯苓120份,白术90份,阿胶30份,地黄120份,山茱萸90份,枸杞子120份,乌梅60份,白芍90份,砂仁60份,益智60份,苎麻根90份,黄芩60份,艾叶10份;
步骤一、将上述原料药除阿胶外,其余均用50~60℃温水浸泡4小时,且水量为用于浸泡的原料药总质量的5倍,浸泡后过滤,滤液备用;
步骤二、将步骤一过滤后的药渣加水煎煮并过滤3次,每次加水量为用于煎煮的药渣质量的4倍,3次煎煮时间分别为2小时、1小时和0.5小时,合并滤液备用;
步骤三、合并步骤一和步骤二获得的滤液,加入上述原料药阿胶,浓缩制成稠膏;
步骤四、将步骤三获得的稠膏减压干燥制成干膏粉;
步骤五、取步骤四获得的干膏粉100克,加入淀粉浆8克、硬脂酸镁0.2克,混匀后填充制得胶囊。
对照实施例2
本具体实施所提供的孕康胶囊的制备方法,由以下各质量份的原料药按下述方法制成:山药150份,续断90份,黄芪120份,当归90份,狗脊120份,菟丝子90份,桑寄生60份,杜仲90份,补骨脂90份,党参90份,茯苓120份,白术90份,阿胶30份,地黄120份,山茱萸90份,枸杞子120份,乌梅60份,白芍90份,砂仁60份,益智60份,苎麻根90份,黄芩60份,艾叶10份;
步骤一、将上述原料药除阿胶外,加水煎煮并过滤3次,每次加水量为用于煎煮的药渣质量的4倍,3次煎煮时间分别为2小时、2小时和1小时,合并滤液备用;
步骤二、向步骤一获得的滤液中加入上述原料药阿胶,浓缩制成稠膏;
步骤三、醇沉步骤二获得的稠膏,取上清液并浓缩制成精制稠膏;
步骤四、将步骤三获得的精制稠膏减压干燥制成干膏粉;
步骤五、取步骤四获得的干膏粉100克,加入淀粉浆8克、硬脂酸镁0.2克,混匀后填充制得胶囊。
试验实施例
实验对象为昆明种小鼠;雌鼠体重为28~30克;雄鼠体重为35~40克;小鼠按2︰1的雌雄比例合笼交配,检出阴栓之日为妊娠第1天,将受孕的雌鼠随机分成7个试验组。
除空白组和模型组外,其余试验组连续给药10天,每天早、晚各一次;与此同时除空白组外,其余试验组于妊娠7~8日连续皮下注射己烯雌酚2天,空白组皮下注射等体积的生理盐水2天。
各试验组小鼠于妊娠第18日处死,解剖,观察各组活胎数。对己烯雌酚所致流产的保胎作用效果见下表1:
表1、己烯雌酚所致流产的保胎作用效果
分组 雌鼠数 剂量 活胎数 活胎率
空白组 20只 -- 16只 100%
模型组 20只 -- 3只 21%
具体实施例1 20只 2g/kg 12只 71%
对照实施例1 20只 2g/kg 7只 47%
对照实施例1 20只 4g/kg 10只 63%
对照实施例2 20只 2g/kg 5只 33%
对照实施例2 20只 4g/kg 6只 35%
由上述表1可知:具体实施例1所提供的孕康胶囊的制备方法所制得的药物具有较好的保胎效果;对照实施例1中由于未经过醇沉精制工艺处理,所制得的孕康胶囊产品效果有所下降,在增加一倍用量后效果能够接近具体实施例1;对照实施例2中原料药未经过温水浸泡,直接采用煎煮方式水提原料药中的有效成分,尽管延长了煎煮的时间,但所制得的孕康胶囊产品效果仍不理想。
以上内容是结合具体的实施例对本发明所作的详细说明,不能认定本发明具体实施仅限于这些说明。对于本发明所属技术领域的技术人员来说,在不脱离本发明构思的前提下,还可以做出若干简单推演或替换,都应当视为属于本发明保护的范围。

Claims (4)

1.一种孕康胶囊的制备方法,其特征是由以下各质量份的原料药按下述方法制成:山药150份,续断90份,黄芪120份,当归90份,狗脊120份,菟丝子90份,桑寄生60份,杜仲90份,补骨脂90份,党参90份,茯苓120份,白术90份,阿胶30份,地黄120份,山茱萸90份,枸杞子120份,乌梅60份,白芍90份,砂仁60份,益智60份,苎麻根90份,黄芩60份,艾叶10份;
步骤一、将上述原料药除阿胶外,其余均用50~60℃温水浸泡后过滤,滤液备用;
步骤二、将步骤一过滤后的药渣加水煎煮后过滤,滤液备用;
步骤三、合并步骤一和步骤二获得的滤液,加入上述原料药阿胶,浓缩制成稠膏;
步骤四、醇沉步骤三获得的稠膏,取上清液并浓缩制成精制稠膏;
步骤五、将步骤四获得的精制稠膏减压干燥制成干膏粉;
步骤六、向步骤五获得的干膏粉中加入硬脂酸镁、淀粉浆,混匀后填充即得。
2.如权利要求1所述的孕康胶囊的制备方法,其特征是,在上述步骤一中,除阿胶外的原料药用50~60℃温水浸泡4小时,且水量为用于浸泡的原料药总质量的5倍。
3.如权利要求2所述的孕康胶囊的制备方法,其特征是,在上述步骤二中,将步骤一过滤后的药渣加水煎煮3次,每次加水量为用于煎煮的药渣质量的4倍,3次煎煮时间分别为2小时、1小时和0.5小时,过滤并合并滤液。
4.如权利要求1至3中任一所述的孕康胶囊的制备方法,其特征是,所述步骤六中,用于混合的干膏粉、淀粉浆和硬脂酸镁的质量份数依次为:100份、5~10份和0.05~0.5份。
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