CN111000832A - 一种含西吡氯铵的口腔膜剂 - Google Patents
一种含西吡氯铵的口腔膜剂 Download PDFInfo
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Abstract
本发明公开了一种含西吡氯铵的口腔膜剂,是由以下重量份的原料药及辅料制成的:西吡氯铵1.0~5.0份,羟丙基纤维素20.0~40.0份,填充剂20.0~30.0份,黄原胶0.5~1.0份,卡波姆0.5~2.0份,增塑剂20.0~40.0份,糖精钠2.0~5.0份。本发明的含有西吡氯铵的口服膜剂,可方便的应用于具有吞咽困难的患者,药物释放平稳,提高了生物利用度及患者顺应性,药物以膜剂形式存在于制剂中,能够延长药物保存期限,兼具掩盖药物不良口味的效果。
Description
技术领域
本发明涉及中药物制剂,更具体的说涉及一种包含西吡氯铵的口腔膜剂。
背景技术
西吡氯铵为阳离子季铵化合物,作为表面活性剂,主要通过降低表面张力而抑制和杀灭细菌。体外试验结果表明本品对多种口腔致病和非致病菌有抑制和杀灭作用,包括白色念珠菌。含能减少或抑制牙菌斑的形成,具有保持口腔清洁、清除口腔异味的作用。
目前国内上市西吡氯铵制剂主要为含漱液,由于含漱液一般体积较大,携带不方便。国内亦有西吡氯铵固体制剂上市,但厂家较少,只有两家片剂上市,主要是西吡氯铵固体制剂需要解决一些技术方面的难点,才能保证西吡氯铵固体制剂在临床应用中患者的依从性和产品的质量稳定性符合要求。申请人在开发西吡氯铵固体制剂的过程中,特别在开发西吡氯铵口腔膜剂的过程中,意外发现了对西吡氯铵口腔膜剂口感和质量起关键作用的影响因素。
膜剂是由成膜材料及药物成分制备的一种固体制剂,能在无需咀嚼和水送服的条件下数分钟内于口腔崩解及释放。膜剂因其制备方法简单、携带方便、无需水送服及咀嚼、起效快,患者顺应性高的优点,特别适用于吞咽困难的卧床病人、老人及儿童患者。由于舌下粘膜富有静脉血管,药物被直接吸收进入血循环,从而避免了肝脏首过效应,提高了药物的生物利用度。
发明内容
针对上述现有技术,本发明提供了一种包含西吡氯铵的口腔膜剂,可方便的应用于具有吞咽困难的患者,药物释放迅速,提高了生物利用度及患者顺应性,能够延长药物保存期限,兼具鉴于现有的西吡氯铵制剂普遍存在含量下降的问题。
本发明是通过以下技术方案实现的:
一种包含西吡氯铵的口腔膜剂,是由以下重量份的原料药及辅料制成的:西吡氯铵1.0~5.0份,羟丙基纤维素20.0~40.0份,填充剂20.0~30.0份,黄原胶0.5~1.0份,卡波姆0.5~2.0份,增塑剂20.0~40.0份,糖精钠2.0~5.0份。
优选的,是由以下重量份的原料药及辅料制成的西吡氯铵3.0份,羟丙基纤维素40.0份,填充剂25.0份,黄原胶1.0份,卡波姆1.0份,增塑剂27.0份,糖精钠3.0份。
所述羟丙基纤维素选自SSL,SL,L,优选L。羟丙基纤维素作为载体,用于抑制药物结晶形成,加速药物释放及掩盖药物不良口味。
所述增塑剂选自甘油,山梨醇,优选山梨醇。
优选的,所述包含西吡氯铵的口腔膜剂,每片规格2.0cm×2.5cm,西吡氯铵的重量含量为:3g/片。
所述包含西吡氯铵的口腔膜剂的制备方法,步骤如下:
(1)制备西吡氯铵溶液:取西吡氯铵和羟丙基纤维素置于混合搅拌器中,加入纯化水中,均匀搅拌使其溶解;
(2)制备包含西吡氯铵的口腔膜剂:
1)将羟丙基纤维素用50℃的60%乙醇溶液分散均匀,得羟丙基纤维素溶液;取黄原胶、卡波姆,分别用水分散均匀,得黄原胶-卡波姆溶液;取增塑剂,用水溶解,得增塑剂溶液;2)将黄原胶-卡波姆溶液加入羟丙基纤维素溶液中,边加边搅拌,加完后室温继续搅拌使混合均匀;3)然后滴加增塑剂溶液,搅拌均匀,得成膜溶液;4)取糖精钠,用水溶解,得糖精钠溶液;5)将西吡氯铵溶液以及糖精钠溶液加入成膜溶液,室温搅拌使混合均匀,超声脱气,静置,得西吡氯铵成膜溶液;6)将西吡氯铵成膜溶液涂布于提前预热的玻璃板上,45℃烘干,即得包含西吡氯铵的口腔膜剂,进行切割(2.0cm×2.5cm)、包装等。
本发明的有益技术效果是:能有效的避免贮存过程中主药的挥发;保持产品质量的长期稳定,确保产品的疗效;掩盖药物的不良气味或味道,提高生物利用度;掩盖药物不良口味的效果。
附图说明
图1体外溶出度比较。
具体实施方式
下面结合实施例对本发明作进一步的说明。
实施例1西吡氯铵的口服速释膜剂的制备
制备含有西吡氯铵的口服速释膜剂制备100片,每片中含西吡氯铵3g,原料及辅料用量为:西吡氯铵3g,羟丙基纤维素40.0g,玉米淀粉25.0g,黄原胶1.0g,卡波姆1.0g,山梨醇:27.0g,糖精钠3.0g。
制备方法步骤如下:
(1)制备西吡氯铵:取西吡氯铵置于混合搅拌器中,加入纯化水,均匀搅拌使其溶解得西吡氯铵溶液;
(2)制备包含西吡氯铵的口腔膜剂:
1)将羟丙基纤维素用50℃的60%乙醇溶液分散均匀,得羟丙基纤维素溶液;取黄原胶、卡波姆,分别用水分散均匀,得黄原胶-卡波姆溶液;取增塑剂,用水溶解,得增塑剂溶液;
2)将黄原胶-卡波姆溶液加入羟丙基纤维素溶液中,边加边搅拌,加完后室温继续搅拌使混合均匀;
3)然后滴加增塑剂溶液,搅拌均匀,得成膜溶液;
4)取糖精钠,用水溶解,得糖精钠溶液;
5)将西吡氯铵溶液以及糖精钠溶液加入成膜溶液,室温搅拌使混合均匀,超声脱气,静置,得西吡氯铵成膜溶液;
6)将西吡氯铵成膜溶液涂布于提前预热的玻璃板上,45℃烘干,即得包含西吡氯铵的口腔膜剂,进行切割(2.0cm×2.5cm)、包装等。
对照例1:制备含有西吡氯铵的口服膜剂
制备100片,每片中含西吡氯铵3g,原料及辅料用量为:西吡氯铵3g,羟丙基甲基纤维素50.0g,甲基纤维素15.0g,明胶2.0g,糖精钠1.0g。
制备方法同实施例1:的步骤(2)。
对照例2:含片(市售品)
实验比较含有西吡氯铵的口服膜剂(实施例1制备)、含有西吡氯铵的口服普通膜剂(对照例1制备)及购买的市售品,剂型为含片。
(一)溶出实验:
实验方法:按照中国药典2015年版四部通则第四法进行实施例和对照例体外溶出度测定。以超声脱气的纯化水为溶出介质,温度37±0.5℃。取膜剂2.0*2.5cm,固定于两层碟片的中央,再将网碟置于溶出杯下部,使其与桨底旋转面平行,相距25±2mm,50r/min的转速5min,10min,15min,20min,30min,45min,60min取释放液5ml并补充同温等量的空白溶出介质,经微孔滤膜过滤后,取续滤液进行紫外测定;
结果:如图1所示,由图1可以看出包含西吡氯铵的膜剂具有比普通膜剂、市售品含片更快的溶出度。
(二)口腔黏膜反应的效果观察实验
实验方法:
选择大鼠36例,随机分为观察组和对照组,两组大鼠相关指标差异无显著性(P>0.05)。
对照组采用普通膜剂,观察组采用实施例1制备的膜剂,3次/d。每日观察记录大鼠进食情况,口腔黏膜变化等。
最后按WHO黏膜反应0~4级标准分级,并进行比较。①0级:无征象及症状;②Ⅰ级:口腔黏膜充血、水肿,点状溃疡;③Ⅱ级:口腔黏膜充血、水肿,点状溃疡;④Ⅲ级:口腔黏膜充血、水肿,片状溃疡,上覆白膜,疼痛加剧并影响进食;⑤Ⅳ级:口腔黏膜大面积溃疡、剧痛,张口困难并不能进食,需肠外营养或经肠营养支持。
实验结果:
两组大鼠口腔黏膜反应出现的时间比较,无统计学意义(P>0.05)。两组口腔黏膜反应程度比较,观察组轻于对照组,差异有显著意义(P<0.05),见表1。
表1两组大鼠口腔黏膜反应比较
(三)牙龈炎及牙菌斑作用的实验:
实验方法:
选择12例固定正畸伴有牙龈炎患者,年龄19~29岁,随机分成实验组和对照组。洁治后8~10d,选择15、13、21、26、35、33、41、46作为指数牙,记录指数牙的菌斑指数、牙龈指数作为基线值,对照组用普通膜剂,实验组以实施例1。分别于4周、8周、12周后记录菌斑指数、牙龈指数。统计学处理方面,纵向比较采用单因素方差分析和student-Newman-Keuls法;横向比较,采用t检验,所有统计均采用SPSS10.0软件统计完成。
实验结果:
1、横向比较:4周时所测临床指数与基线水平比较,实验组与对照组间无显著差异(P>0.05);8周时菌斑指数有显著性差异(P<0.05),牙龈指数有显著性差异(P<0.01);12周时,实验组各项指数均低于对照组,有显著性差异(P<0.01)。
2、纵向比较:对照组与基线值比较,4周、8周、12周时,所测各项指数均值均无显著性差异(P>0.05);实验组与基线值比较,4周、8周时菌斑指数降低均有显著性差异(P<0.05),12周时菌斑指数降低有显著性差异(P<0.01);与基线值比较,4周时牙龈指数变化无统计学意义(P>0.05),8周时,12周时牙龈指数明显降低(P<0.01),见表2。
表2对照组和实验组各项临床参数比较
注:*P<0.05,**P<0.01为横向比较。
Claims (6)
1.一种包含西吡氯铵的口腔膜剂,其特征在于:是由以下重量份的原料药和辅料制成的:西吡氯铵1.0~5.0份,羟丙基纤维素20.0~40.0份,填充剂20.0~30.0份,黄原胶0.5~1.0份,卡波姆0.5~2.0份,增塑剂20.0~40.0份,糖精钠2.0~5.0份。
2.根据权利要求1所述的包含西吡氯铵的口腔膜剂,其特征在于:是由以下重量份的原料药及辅料制成的:西吡氯铵3.0份,羟丙基纤维素40.0份,填充剂25.0份,黄原胶1.0份,卡波姆1.0份,增塑剂27.0份,糖精钠3.0份。
3.根据权利要求2所述的包含西吡氯铵的口腔膜剂,其特征在于:所述羟丙基纤维素型号选自SSL,SL,L。
4.根据权利要求2所述的包含西吡氯铵的口腔膜剂,其特征在于:所述增塑剂选自甘油,山梨醇。
5.根据权利要求1~4中任一项所述的包含西吡氯铵的口腔膜剂的制备方法,其特征在于:步骤如下:
1)制备西吡氯铵:取西吡氯铵和羟丙基纤维素置于混合搅拌器中,加入纯化水中,均匀搅拌使其溶解;
2)制备包含西吡氯铵的口腔膜剂。
6.根据权利要求5所述的包含西吡氯铵的口腔膜剂的制备方法,其特征在于:步骤2)所述:制备包含西吡氯铵的口腔膜剂包括以下步骤:
1)将羟丙基纤维素用50℃的60%乙醇溶液分散均匀,得羟丙基纤维素溶液;取黄原胶、卡波姆,分别用水分散均匀,得黄原胶-卡波姆溶液;取增塑剂,用水溶解,得增塑剂溶液;
2)将黄原胶-卡波姆溶液加入羟丙基纤维素溶液中,边加边搅拌,加完后室温继续搅拌使混合均匀;
3)然后滴加增塑剂溶液,搅拌均匀,得成膜溶液;
4)取糖精钠,用水溶解,得糖精钠溶液;
5)将西吡氯铵溶液以及糖精钠溶液加入成膜溶液,室温搅拌使混合均匀,超声脱气,静置,得西吡氯铵成膜溶液;
6)将西吡氯铵成膜溶液涂布于提前预热的玻璃板上,45℃烘干,即得包含西吡氯铵的口腔膜剂。
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CN109700786A (zh) * | 2018-12-28 | 2019-05-03 | 重庆健能医药开发有限公司 | 一种含枸橼酸莫沙必利固体分散体的口腔膜剂 |
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CN109700786A (zh) * | 2018-12-28 | 2019-05-03 | 重庆健能医药开发有限公司 | 一种含枸橼酸莫沙必利固体分散体的口腔膜剂 |
Non-Patent Citations (1)
Title |
---|
M. FRIEDMAN等: "Inhibition of plaque formation by a sustained release delivery system for cetylpyridinium chloride" * |
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