CN1255131C - 汉桃叶软胶囊及其制备方法 - Google Patents

汉桃叶软胶囊及其制备方法 Download PDF

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CN1255131C
CN1255131C CN 03117241 CN03117241A CN1255131C CN 1255131 C CN1255131 C CN 1255131C CN 03117241 CN03117241 CN 03117241 CN 03117241 A CN03117241 A CN 03117241A CN 1255131 C CN1255131 C CN 1255131C
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soft capsule
schefflerae arboricolae
radix schefflerae
extract
cera flava
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CN1454631A (zh
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张乐陵
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Guizhou Sanli Pharmaceutical Co ltd
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Abstract

本发明是一种汉桃叶软胶囊及其制备方法,它将汉桃叶采用水提或者醇提的方法提取出提取物再与食用油、蜂蜡混合均匀,灌装、压制成软胶囊,与现有技术相比:本发明构成简单、制作方法不复杂,生产工艺容易受到控制,能够保证药品的质量,本药品用于对三叉神经痛、神经性头痛、坐骨神经痛、风湿关节痛等疾病的治疗,疗效比较肯定。

Description

汉桃叶软胶囊及其制备方法
技术领域:本发明是一种汉桃叶软胶囊及其制备方法,属于中药技术领域。
技术背景:将汉桃叶作为治疗身体疼痛的药物是我国劳动人民长期生活的实践,现有技术中一般将其制作成为片剂供患者服用;但是其在制作过程中由于在工艺上需要添加一些辅助原料,比如:需要加入黏合剂,这样在实际使用过程中发现它的制剂稳定性特别差,药品易吸潮、霉变、裂片而影响了药品的质量;另外由于这种片剂为固体物,口服崩解后的粗颗粒需要溶散过程,起效速度比较缓慢,且粗颗粒表面积小而影响吸收,生物利用度比较低,为了达到治疗目的需要服用的量比较大,才能解决问题。
发明内容:本发明的目的在于:提供一种汉桃叶软胶囊及其制备方法,这种药品是一种软胶囊制剂,在制作过程中其汉桃叶的提取物不经制粒,使其分散在油状基质中,经胶皮压制完全密封,克服了吸潮性、增加了药品的稳定性、提高了生物利用度,增强了药品的疗效,降低服用的数量,减轻患者的心理负担;本发明是这样构成的:汉桃叶软胶囊,是按照重量组份计算,它由汉桃叶提取物1份与食用油0.3-3份、蜂蜡0.005-0.035份配制而成;具体地说:按照重量组份计算,它由汉桃叶提取物1份与豆油1份、蜂蜡0.02份配制而成;这种汉桃叶软胶囊的制备方法,按照重量组份:将汉桃叶采用水提或者醇提的方法提取出提取物1份再与食用油0.3-3份、蜂蜡0.005-0.035份混合均匀,灌装、压制成软胶囊;具体地说:取汉桃叶加6-20倍重量的水,煎煮1-4次,合并煎液,过滤,滤液减压浓缩至相对密度为1.15-1.20(60℃),加乙醇至含醇量达50-80%,静置沉淀,滤过,滤液回收乙醇并浓缩至相对密度为1.20-1.25(60℃),经干燥得提取物干粉,将干粉过100目筛,再按照给定的比例加食用油和蜂蜡,混匀,灌装、压制成软胶囊,食用油除豆油外,可以是市售食用油,如:菜油、花生油、调和油等等。
与现有技术相比:本发明构成简单、制作方法不复杂,生产工艺容易受到控制,能够保证药品的质量,实际上汉桃叶作为相关的药品已经在市场上流通,但是由于其存在的问题,所以本申请人在试验过程中进行了新的研究,主要是针对剂型的研究,通过研究表明:以汉桃叶作为主要原料制备这种药物,在口服药品中选用别的剂型均不能够较好的达到发明的目的;有的药品剂型要么粉状颗粒大,生物利用度低、患者吸收效果差,疗效不理想;有的剂型制备时用特别细小的粉状颗粒,但是又满足不了生产工艺的要求;比如制作片剂,如果原料的颗粒特别细小、不加黏合剂进行制粒,就会使制备比较困难、影响药品的质量;所以经过反复试验本申请人选定了将其制作成软胶囊制剂;由于在制作过程中汉桃叶的提取物不经制粒,使其分散在油状基质中,经胶皮压制完全密封,克服了吸潮性、增加了药品的稳定性,软胶囊内的药物为极细粉,崩解后直接分布在体液中进行吸收,起效比较快,且因表面积较大易于吸收而生物利用度较高,增强了药品的疗效,在对于相关病症的治疗中本药品的剂量确定、服用量小;对比之下,软胶囊每日服用量相当于有效物质1.8g,而片剂每日服用量相当于有效物质2.7g-4.5g;本药品用于对三叉神经痛、神经性头痛、坐骨神经痛、风湿关节痛等疾病的治疗,疗效比较肯定;口服一次3粒、一日三次。
本发明的实施例1:取汉桃叶加16倍重量的水,煎煮2次,合并煎液,过滤,滤液减压浓缩至相对密度为1.15-1.20(60℃),加乙醇至含醇量达60%,静置沉淀,滤过,滤液回收乙醇并浓缩至相对密度为1.20-1.25(60℃),经干燥得提取物干粉,将干粉过100目筛,再按照汉桃叶提取物1公斤与豆油1公斤、蜂蜡0.02公斤的比例加入豆油和蜂蜡,混匀,灌装、压制成软胶囊。
本发明的实施例2:取汉桃叶加20倍重量的水,煎煮4次,合并煎液,过滤,滤液减压浓缩至相对密度为1.15-1.20(60℃),加乙醇至含醇量达80%,静置沉淀,滤过,滤液回收乙醇并浓缩至相对密度为1.20-1.25(60℃),经干燥得提取物干粉,将干粉过100目筛,再按照汉桃叶提取物1公斤与菜油3公斤、蜂蜡0.035公斤的比例加豆油和蜂蜡,混匀,灌装、压制成软胶囊。
本发明的实施例3:取汉桃叶加6倍重量的水,煎煮1次,合并煎液,过滤,滤液减压浓缩至相对密度为1.15-1.20(60℃),加乙醇至含醇量达50%,静置沉淀,滤过,滤液回收乙醇并浓缩至相对密度为1.20-1.25(60℃),经干燥得提取物干粉,将干粉过100目筛,再按照汉桃叶提取物1公斤与调和油0.3公斤、蜂蜡0.005公斤的比例加豆油和蜂蜡,混匀,灌装、压制成软胶囊。
本发明的实施例4:取汉桃叶用乙醇按照常规技术进行醇提,得到的提取物干粉过筛,再按照汉桃叶提取物1公斤与豆油1.5公斤、蜂蜡0.005公斤的比例加花生油和蜂蜡,混匀,灌装、压制成软胶囊。
本发明为汉桃叶的利用提供了一种新的药物剂型,在进行实际检测中我们发现:使用现有的片剂,每日的服用量相当于有效物质2.7-4.5克,而本发明提供的药品每日服用量相当于有效物质1.8克;在片剂的使用说明中,规定了口服每日三次、一次3-5片,而本药品仅仅需要服用3粒即可;也就是说:在同等疗效状态下服用量少于现有药品的服用量,这样节省了药用资源、降低了生产成本,解决了患者对需要大量服用片剂而产生厌恶的心理反应,能够比较好的对相关病症进行治疗。

Claims (4)

1、一种汉桃叶软胶囊,其特征在于:按照重量组份计算,它由汉桃叶提取物1份与食用油0.3-3份、蜂蜡0.005-0.035份配制而成。
2、按照权利要求1所述的汉桃叶软胶囊,其特征在于:按照重量组份计算,它由汉桃叶提取物1份与豆油1份、蜂蜡0.02份配制而成。
3、一种汉桃叶软胶囊的制备方法,其特征在于:按照重量组份:将汉桃叶采用水提或者醇提的方法提取出提取物1份再与食用油0.3-3份、蜂蜡0.005-0.035份混合均匀,灌装、压制成软胶囊。
4、按照权利要求3所述的汉桃叶软胶囊的制备方法,其特征在于:取汉桃叶加6-20倍重量的水,煎煮1-4次,合并煎液,过滤,滤液减压浓缩至60℃时测相对密度为1.15-1.20,加乙醇至含醇量达50-80%,静置沉淀,滤过,滤液回收乙醇并浓缩至60℃时测相对密度为1.20-1.25,经干燥得提取物干粉,将干粉过100目筛,再按照给定的比例加食用油和蜂蜡,混匀,灌装、压制成软胶囊。
CN 03117241 2003-01-24 2003-01-24 汉桃叶软胶囊及其制备方法 Expired - Lifetime CN1255131C (zh)

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CN1293910C (zh) * 2005-02-25 2007-01-10 张海峰 一种复方天麻素注射制剂及其制备和应用
CN102600369A (zh) * 2011-01-20 2012-07-25 北京联馨药业有限公司 一种用于治疗偏头痛的中药组合物、其制备方法及用途
CN102836190A (zh) * 2012-09-25 2012-12-26 广西金海堂药业有限责任公司 一种汉桃叶总黄酮浸膏的制备及质量控制方法
CN106727796A (zh) * 2015-11-19 2017-05-31 哈尔滨圣吉药业股份有限公司 一种汉桃叶分散片及其制备方法
CN110279735B (zh) * 2019-08-09 2021-07-09 金鸿药业股份有限公司 一种汉桃叶有效部位及其制备方法

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