CN115025055A - 一种含有桑黄提取物的分散片及其制备方法 - Google Patents
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Abstract
本发明公开了一种含有桑黄提取物的分散片及其制备方法,涉及中药制剂技术领域,本发明将桑黄提取物制剂化得到分散片,赋予了桑黄提取物携带和服用方便、剂量准确的优点,采用的是经有机溶剂提取制得的桑黄提取物,所含活性成分较高,解决了常规水提法制备的桑黄提取物所含活性成分低以及携带和服用不便的问题;并且该分散片崩解迅速,溶出性好,能够有效提高桑黄提取物的生物利用度,起效快,药效强。
Description
技术领域:
本发明涉及中药制剂技术领域,具体涉及一种含有桑黄提取物的分散片及其制备方法。
背景技术:
桑黄,中药名,为多孔菌科真菌火木层孔菌的子实体,具有活血、止血、化饮、止泻之功效,常用于血崩、血淋、脱肛泻血、带下、经闭、症瘕积聚、癖饮、脾虚泄泻。桑黄作为我国传统真菌类中药,包含多糖、黄酮、三萜类、芳香酸、氨基酸等化学成分,具有免疫调节、抗氧化、抗炎、抗癌等多种药理活性。
本领域通常采用乙醇提取桑黄活性成分,再将桑黄提取物应用于疾病的预防或治疗。本发明将桑黄提取物与制剂辅料混合后制成分散片,在水中能迅速崩解并均匀分散,具有服用方便、吸收快和生物利用度等特点。
发明内容:
本发明所要解决的技术问题在于提供一种含有桑黄提取物的分散片及其制备方法,采用稀释剂、崩解剂、粘合剂和润滑剂作为制剂辅料,制得的分散片比普通片剂具有崩解速度快、分散均匀、溶出度高的特点,可以在消化道内高效吸收,从而提高桑黄提取物的生物利用度;还可以将其先在水中分散再服用,解决特殊人群吞咽片剂困难的问题。
本发明所要解决的技术问题采用以下的技术方案来实现:
本发明的第一个目的是提供一种含有桑黄提取物的分散片,由以下重量百分比的原料制备而成:
优选地,由以下重量百分比的原料制备而成:
所述桑黄提取物的活性成分含量为20-40%。桑黄提取物的活性成分主要包括桑黄多糖、桑黄总黄酮和桑黄总三萜。
所述稀释剂为预胶化淀粉、微晶纤维素、乳糖、甘露醇中的至少一种。稀释剂又称填充剂,主要作用是增加片剂的重量或体积,利于成型和分剂量。
所述崩解剂为交联聚维酮、羧甲基淀粉钠、羟丙基纤维素中的至少一种。由于药物被较大压力压成片剂后孔隙率很小,结合力很强,即使在水中易溶解的药物在压成片剂后其在水中溶解或崩解也需要一定的时间。崩解剂的主要作用在于消除因粘合剂或由加压而形成片剂的结合力使片剂崩解。
所述粘合剂为淀粉、聚维酮、羟丙基甲基纤维素中的至少一种。粘合剂为溶液形式,采用水或者乙醇作溶剂。粘合剂的作用是将粉料润湿后粘合成颗粒以便于压片。
所述润滑剂为硬脂酸镁、聚乙二醇、滑石粉中的至少一种。润滑剂可以降低颗粒或片剂与冲模壁间的摩擦力,使压片时压力分布均匀,并减小片剂由模孔中推出所需之力;还能改善片剂的外观,使片剂表面光亮、平整。
本发明的第二个目的是提供一种含有桑黄提取物的分散片的制备方法,包括以下步骤:
(1)分别将桑黄提取物、稀释剂、崩解剂、粘合剂和润滑剂经干燥后粉碎、过筛,备用;
(2)按照重量配比,分别称取经步骤(1)处理所得的桑黄提取物、稀释剂、崩解剂、粘合剂和润滑剂;
(3)先将稀释剂和崩解剂混合,然后加入桑黄提取物混合,再加入粘合剂和润滑剂混合,得到粉料;
(4)将步骤(2)所得粉料直接压片,得到含有桑黄提取物的分散片。
所述过筛目数为80-100目。颗粒度对药物的质量有着直接的影响,颗粒度对药物的溶出性能也起着决定作用。
所述干燥温度不超过100℃。控制原料的干燥温度,一方面可以缩短干燥时间,另一方面能够避免高温干燥引发的原料变质问题。
上述技术方案制备的分散片在100s内全部崩解并通过药典二号筛。
鉴于崩解剂直接影响分散片的应用效果,本发明的第三个目的是提供一种崩解剂的制备方法,采用该崩解剂替代本领域常用的交联聚维酮、羧甲基淀粉钠和羟丙基纤维素,缩短崩解时限,提高分散均匀性。采用该崩解剂制备的分散片在80s内全部崩解并通过药典二号筛。
所述崩解剂是由羟丙基纤维素与N-异丙基-2-氯乙酰胺反应制得,羟丙基纤维素与N-异丙基-2-氯乙酰胺的摩尔用量比为1:(3-5)。通过反应将羟丙基纤维素分子结构中的部分-OH转变为-O-CH2-CONH-CH(CH3)2,制得的改性羟丙基纤维素属于吸湿膨胀型崩解剂,其崩解效果远优于羟丙基纤维素。
对于崩解剂来说,不仅要求其具有超强的吸水性,还必须具备快速吸水膨胀的效果,才能实现分散片的快速崩解以及均匀分散,上述技术方案就是通过对现有崩解剂羟丙基纤维素的结构改性来调控其吸水性和膨胀性,缩短崩解时限,保证分散均匀性。
本发明的有益效果是:本发明将桑黄提取物制剂化得到分散片,赋予了桑黄提取物携带和服用方便、剂量准确的优点,采用的是经有机溶剂提取制得的桑黄提取物,所含活性成分较高,解决了常规水提法制备的桑黄提取物所含活性成分低以及携带和服用不便的问题;并且该分散片崩解迅速,溶出性好,能够有效提高桑黄提取物的生物利用度,起效快,药效强。
具体实施方式:
为了使本发明实现的技术手段、创作特征、达成目的与功效易于明白了解,下面结合具体实施例,进一步阐述本发明。
本发明的桑黄提取物购于武汉能仁医药化工有限公司。
实施例1
(1)分别将桑黄提取物、稀释剂、崩解剂、粘合剂和润滑剂经80℃干燥后粉碎、过100目筛,备用;
(2)按照上述重量配比,分别称取经步骤(1)处理所得的桑黄提取物、稀释剂、崩解剂、粘合剂和润滑剂;
(3)先将稀释剂和崩解剂混合,然后加入桑黄提取物混合,再加入粘合剂和润滑剂混合,得到粉料;
(4)将步骤(2)所得粉料直接压片,得到含有桑黄提取物的分散片。
实施例2
(1)分别将桑黄提取物、稀释剂、崩解剂、粘合剂和润滑剂经80℃干燥后粉碎、过100目筛,备用;
(2)按照上述重量配比,分别称取经步骤(1)处理所得的桑黄提取物、稀释剂、崩解剂、粘合剂和润滑剂;
(3)先将稀释剂和崩解剂混合,然后加入桑黄提取物混合,再加入粘合剂和润滑剂混合,得到粉料;
(4)将步骤(2)所得粉料直接压片,得到含有桑黄提取物的分散片。
实施例3
(1)分别将桑黄提取物、稀释剂、崩解剂、粘合剂和润滑剂经80℃干燥后粉碎、过100目筛,备用;
(2)按照上述重量配比,分别称取经步骤(1)处理所得的桑黄提取物、稀释剂、崩解剂、粘合剂和润滑剂;
(3)先将稀释剂和崩解剂混合,然后加入桑黄提取物混合,再加入粘合剂和润滑剂混合,得到粉料;
(4)将步骤(2)所得粉料直接压片,得到含有桑黄提取物的分散片。
实施例4
(1)分别将桑黄提取物、稀释剂、崩解剂、粘合剂和润滑剂经80℃干燥后粉碎、过100目筛,备用;
(2)按照上述重量配比,分别称取经步骤(1)处理所得的桑黄提取物、稀释剂、崩解剂、粘合剂和润滑剂;
(3)先将稀释剂和崩解剂混合,然后加入桑黄提取物混合,再加入粘合剂和润滑剂混合,得到粉料;
(4)将步骤(2)所得粉料直接压片,得到含有桑黄提取物的分散片。
实施例5
(1)分别将桑黄提取物、稀释剂、崩解剂、粘合剂和润滑剂经80℃干燥后粉碎、过100目筛,备用;
(2)按照上述重量配比,分别称取经步骤(1)处理所得的桑黄提取物、稀释剂、崩解剂、粘合剂和润滑剂;
(3)先将稀释剂和崩解剂混合,然后加入桑黄提取物混合,再加入粘合剂和润滑剂混合,得到粉料;
(4)将步骤(2)所得粉料直接压片,得到含有桑黄提取物的分散片。
实施例6
本实施例只是将实施例5中的羟丙基纤维素替换为改性羟丙基纤维素,改性羟丙基纤维素是由羟丙基纤维素与N-异丙基-2-氯乙酰胺反应制得,羟丙基纤维素与N-异丙基-2-氯乙酰胺的摩尔用量比为1:3。
改性羟丙基纤维素的制备方法:将羟丙基纤维素和碳酸钾溶解于水中,升温至60-65℃后开始滴加N-异丙基-2-氯乙酰胺,滴加完毕后继续在60-65℃下保温至N-异丙基-2-氯乙酰胺反应完全,冷却至室温后加乙醇进行沉淀,过滤,滤渣烘干,破碎成粉体,得到改性羟丙基纤维素。
实施例7
本实施例只是将实施例5中的羟丙基纤维素替换为改性羟丙基纤维素,改性羟丙基纤维素是由羟丙基纤维素与N-异丙基-2-氯乙酰胺反应制得,羟丙基纤维素与N-异丙基-2-氯乙酰胺的摩尔用量比为1:4,改性羟丙基纤维素的制备方法同实施例6。
实施例8
本实施例只是将实施例5中的羟丙基纤维素替换为改性羟丙基纤维素,改性羟丙基纤维素是由羟丙基纤维素与N-异丙基-2-氯乙酰胺反应制得,羟丙基纤维素与N-异丙基-2-氯乙酰胺的摩尔用量比为1:5,改性羟丙基纤维素的制备方法同实施例6。
对照例
本实施例只是将实施例5中的羟丙基纤维素替换为改性羟丙基纤维素,改性羟丙基纤维素是由羟丙基纤维素与氯乙酰胺反应制得,羟丙基纤维素与氯乙酰胺的摩尔用量比为1:4,改性羟丙基纤维素的制备方法同实施例6。
按照《中国药典》2010版二部附录I A片剂“分散均匀性”对实施例1-7制备的分散片进行分散均匀性测试,取供试品5片,置于20±1℃的100mL水中,振摇,记录完全崩解的时间,取平均值作为测试分散片的分散均匀性指标,结果见表1。
表1
以上显示和描述了本发明的基本原理和主要特征和本发明的优点。本行业的技术人员应该了解,本发明不受上述实施例的限制,上述实施例和说明书中描述的只是说明本发明的原理,在不脱离本发明精神和范围的前提下,本发明还会有各种变化和改进,这些变化和改进都落入要求保护的本发明范围内。本发明要求保护范围由所附的权利要求书及其等效物界定。
Claims (10)
3.根据权利要求1或2所述的含有桑黄提取物的分散片,其特征在于:所述桑黄提取物的活性成分含量为20-40%。
4.根据权利要求1或2所述的含有桑黄提取物的分散片,其特征在于:所述稀释剂为预胶化淀粉、微晶纤维素、乳糖、甘露醇中的至少一种。
5.根据权利要求1或2所述的含有桑黄提取物的分散片,其特征在于:所述崩解剂为交联聚维酮、羧甲基淀粉钠、羟丙基纤维素中的至少一种。
6.根据权利要求1或2所述的含有桑黄提取物的分散片,其特征在于:所述粘合剂为淀粉、聚维酮、羟丙基甲基纤维素中的至少一种。
7.根据权利要求1或2所述的含有桑黄提取物的分散片,其特征在于:所述润滑剂为硬脂酸镁、聚乙二醇、滑石粉中的至少一种。
8.根据权利要求1或2所述的含有桑黄提取物的分散片,其特征在于,其制备方法包括以下步骤:
(1)分别将桑黄提取物、稀释剂、崩解剂、粘合剂和润滑剂经干燥后粉碎、过筛,备用;
(2)按照重量配比,分别称取经步骤(1)处理所得的桑黄提取物、稀释剂、崩解剂、粘合剂和润滑剂;
(3)先将稀释剂和崩解剂混合,然后加入桑黄提取物混合,再加入粘合剂和润滑剂混合,得到粉料;
(4)将步骤(2)所得粉料直接压片,得到含有桑黄提取物的分散片。
9.根据权利要求8所述的含有桑黄提取物的分散片,其特征在于:所述过筛目数为80-120目。
10.根据权利要求8所述的含有桑黄提取物的分散片,其特征在于:所述干燥温度不超过100℃。
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