CN108721461A - 一种敛痔散的制备方法 - Google Patents
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Abstract
本发明涉及一种敛痔散的制备方法,敛痔散的原料药包括黄芩、黄连、黄柏、大黄、煅炉甘石、冰片和血竭,其制备方法为:首先将煅炉甘石、冰片和血竭分别过120目筛;其次,将黄芩、黄连、黄柏、大黄加水提取并浓缩,得到四黄汤浓缩液;然后将浓缩液与已过筛的炉甘石粉末搅拌混匀,干燥,粉碎,得到四黄汤制炉甘石粉末;然后将粉末与已过筛的冰片、血竭粉末混匀,过120目筛,总混得到敛痔散。本发明提供的敛痔散制备工艺生产周期短、生产效率高。
Description
技术领域
本发明涉及一种敛痔散的制备方法。
背景技术
散剂系指原料药物或与适宜的辅料经粉碎、均匀混合制成的干燥粉末状制剂。敛痔散是利用植物药提取液与矿物药、合成药及树脂类中药药粉混匀,不用辅料的外用散剂。
中国专利CN102198205A于2011-09-28公开了一种敛痔散的制备方法,包括如下步骤:将96.5%制甘石、1%冰片、2.5%血竭均匀混合,之后粉碎并研磨,过筛即可,所述的百分比为质量百分比;其中,所述的制甘石由下述方法制得:将生甘石用武火烧红后倒入四黄汤内淬化、收集混悬液,未淬透的生甘石重复操作一次,将收集的混悬液静置并收集沉淀、除水即得;所述的四黄汤由黄芩、黄连、黄柏和大黄煎汤得到;所述的四黄汤的剂量为每50kg生甘石用1kg黄芩、0.5kg黄连、1kg黄柏和2kg大黄;所述的四黄汤由下述方法制备,将1kg黄芩、0.5kg黄连、1kg黄柏和2kg大黄与25kg水煎煮取提取液,之后再加25kg水煎煮再取提取液,即得四黄汤;所述的煎煮的时间为30min-45min。
1、“敛痔散”功效:具有清热解毒、活血化瘀、消肿止痛、祛腐生肌、收敛之功效。
2、“敛痔散”适应症:适用于痔疮(内痔、外痔、混合痔)、肛瘘、肛周脓肿等肛肠病手术后创面,能够改善肛肠病术后创面疼痛、消除水肿、缩短创面愈合时间;也可用于内痔出血、外痔疼痛、肛裂等症状;并适用于其他各类外科疮、疡、痈、疖等创面。
具体到临床应用上,根据不同病症使用方法亦有不同。散剂用于手术后的创面,易喷洒,止血、生肌、收敛作用强。如内痔出血、外痔疼痛、肛裂、褥疮等情况,可用蜂蜡或麻油或凡士林调成油膏,效果更佳。
3、“敛痔散”禁忌症:对“敛痔散”过敏者禁用。
敛痔散传统制备工艺属于传统中药炮制工艺的煅制法,需要对炉甘石进行反复的淬煅,生产工艺复杂,而且生产周期长,在反复操作的过程中,很难实现工艺过程的可控化,产品的批间一致性差。
发明内容
针对现有技术的上述不足,根据本发明的实施例,希望提供一种敛痔散的制备方法,通过该方法制得的散剂敛痔散生产周期短、生产效率高。
根据实施例,本发明提供的一种敛痔散的制备方法,所述敛痔散的原料药包括黄芩、黄连、黄柏、大黄、煅炉甘石、冰片和血竭,其制备方法包括以下步骤:
①将煅炉甘石、冰片和血竭分别过120目筛;
②将黄芩、黄连、黄柏、大黄加水提取3次,合并各次煎液并浓缩,得到四黄汤浓缩液;③将②中所述的浓缩液与①中所述的炉甘石粉末搅拌混匀,干燥,粉碎,得到四黄汤制炉甘石粉末;
④将③中所述四黄汤制炉甘石粉末与①中所述的冰片、血竭混匀,过120目筛,总混得到敛痔散。
根据一个实施例,本发明前述敛痔散的制备方法中,所述的煅炉甘石可自行按照药典规定方法煅制,也可使用市售煅炉甘石。
根据一个实施例,本发明前述敛痔散的制备方法中,所述的提取的加水量是10倍量。
根据一个实施例,本发明前述敛痔散的制备方法中,所述的提取的时间是每次30分钟。
根据一个实施例,本发明前述敛痔散的制备方法中,所述的浓缩温度是70~80℃。
根据一个实施例,本发明前述敛痔散的制备方法中,所述的浓缩密度是1.01~1.02g/cm3。
根据一个实施例,本发明前述敛痔散的制备方法中,所述的干燥条件是80℃真空。
根据一个实施例,本发明前述敛痔散的制备方法中,所述的干燥程度是水分符合药典对散剂的水分要求(2015版药典规定低于9%)。
根据一个实施例,本发明前述敛痔散的制备方法中,所述的四黄汤制炉甘石粉末与冰片、血竭的混匀采取等量递增法结合过筛混匀的方式。
本发明的有益效果:和中国专利CN102198205A公开的传统的制备工艺相比,本发明提供的敛痔散的制备工艺具有以下优势:无需对炉甘石进行反复的淬煅,生产周期短、生产效率高,整个制备工艺可控,敛痔散产品的批间一致性好。
具体实施方式
下面结合具体实施例,进一步阐述本发明。这些实施例应理解为仅用于说明本发明而不用于限制本发明的保护范围。在阅读了本发明记载的内容之后,本领域技术人员可以对本发明作各种改动或修改,这些等效变化和修改同样落入本发明权利要求所限定的范围。
本发明实施例公布了一种敛痔散的制备方法,敛痔散的原料药包括黄芩、黄连、黄柏、大黄、煅炉甘石、冰片和血竭,原料药之间的配伍同中国专利CN102198205A,制备方法包括以下步骤:
①将煅炉甘石、冰片和血竭分别过120目筛;②将黄芩、黄连、黄柏、大黄提取加水量、提取次数与提取时间优化为加10倍量水、提取3次、每次30分钟,合并各次煎液并浓缩,浓缩温度为70~80℃,为保证浓缩液能与炉甘石粉末混合均匀,浓缩密度为1.01~1.02g/cm3;③将②中所述的浓缩液与①中所述的炉甘石粉末搅拌混匀,在80℃真空下干燥至水分符合药典对散剂的要求,粉碎,得到四黄汤制炉甘石粉末;④将③中所述四黄汤制炉甘石粉末与①中所述的冰片、血竭混匀,过120目筛,总混得到敛痔散。
实施例1
将煅炉甘石50kg过100目筛,冰片500g和血竭1.26kg过120目筛;再将黄芩1kg、黄连500g、黄柏1kg、大黄2kg加6倍量水提取1次,提取时间为30分钟,提取液于70℃浓缩,得到四黄汤浓缩液;然后将浓缩液与已过筛的炉甘石粉末搅拌混匀,干燥,粉碎,得到四黄汤制炉甘石粉末;然后将粉末与已过筛的冰片、血竭粉末混匀,过120目筛,总混得到敛痔散。
实施例2
将煅炉甘石50kg、冰片500g和血竭1.26kg分别过120目筛;再将黄芩1kg、黄连500g、黄柏1kg、大黄2kg加8倍量水提取2次,提取时间为30分钟,提取液于75℃浓缩,得到四黄汤浓缩液;然后将浓缩液与已过筛的炉甘石粉末搅拌混匀,干燥,粉碎,得到四黄汤制炉甘石粉末;然后将粉末与已过筛的冰片、血竭粉末混匀,过120目筛,总混得到敛痔散。
实施例3
将煅炉甘石50kg过100目筛,冰片500g和血竭1.26kg过120目筛;再将黄芩1kg、黄连500g、黄柏1kg、大黄2kg加8倍量水提取1次,提取时间为60分钟,提取液于80℃浓缩,得到四黄汤浓缩液;然后将浓缩液与已过筛的炉甘石粉末搅拌混匀,干燥,粉碎,得到四黄汤制炉甘石粉末;然后将粉末与已过筛的冰片、血竭粉末混匀,过120目筛,总混得到敛痔散。
实施例4
将煅炉甘石50kg、冰片500g和血竭1.26kg分别过120目筛;再将黄芩1kg、黄连500g、黄柏1kg、大黄2kg加10倍量水提取3次,提取时间为30分钟,提取液于70℃浓缩,得到四黄汤浓缩液;然后将浓缩液与已过筛的炉甘石粉末搅拌混匀,干燥,粉碎,得到四黄汤制炉甘石粉末;然后将粉末与已过筛的冰片、血竭粉末混匀,过120目筛,总混得到敛痔散。
实施例5
将煅炉甘石50kg过200目筛,冰片500g和血竭1.26kg过120目筛;再将黄芩1kg、黄连500g、黄柏1kg、大黄2kg加10倍量水提取3次,提取时间为60分钟,提取液于80℃浓缩,得到四黄汤浓缩液;然后将浓缩液与已过筛的炉甘石粉末搅拌混匀,干燥,粉碎,得到四黄汤制炉甘石粉末;然后将粉末与已过筛的冰片、血竭粉末混匀,过120目筛,总混得到敛痔散。
本发明不局限于上述最佳实施方式,任何人在本发明的启示下所作的有关本发明的任何修饰或变更,凡是具有与本申请相同或相近似的技术方案,均落在本发明的保护范围之内。
Claims (9)
1.一种敛痔散的制备方法,所述敛痔散的原料药包括黄芩、黄连、黄柏、大黄、煅炉甘石、冰片和血竭,其特征在于,该制备方法包括以下步骤:
①将煅炉甘石、冰片和血竭分别过120目筛;
②将黄芩、黄连、黄柏、大黄加水提取3次,合并各次煎液并浓缩,得到四黄汤浓缩液;
③将②中所述的浓缩液与①中所述的炉甘石粉末搅拌混匀,干燥,粉碎,得到四黄汤制炉甘石粉末;
④将③中所述四黄汤制炉甘石粉末与①中所述的冰片、血竭混匀,过120目筛,总混得到敛痔散。
2.根据权利要求1所述的敛痔散的制备方法,其特征在于:所述的煅炉甘石按照药典规定方法煅制,或使用市售煅炉甘石。
3.根据权利要求1所述的敛痔散的制备方法,其特征在于:所述的提取的加水量为药材的10倍量。
4.根据权利要求1所述的敛痔散的制备方法,其特征在于:所述的提取的时间为每次30分钟。
5.根据权利要求1所述的敛痔散的制备方法,其特征在于:所述的浓缩温度是70~80℃。
6.根据权利要求1所述的敛痔散的制备方法,其特征在于:所述的浓缩密度是1.01~1.02g/cm3。
7.根据权利要求1所述的敛痔散的制备方法,其特征在于:所述的干燥条件是80℃减压干燥或常压干燥。
8.根据权利要求1所述的敛痔散的制备方法,其特征在于:所述的干燥程度是水分低于9%。
9.根据权利要求1所述的敛痔散的制备方法,其特征在于:所述的四黄汤制炉甘石粉末与冰片、血竭的混匀采取等量递增法结合过筛混匀的方式。
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