CN1330314C - 西地碘口含片 - Google Patents

西地碘口含片 Download PDF

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CN1330314C
CN1330314C CNB2004100003896A CN200410000389A CN1330314C CN 1330314 C CN1330314 C CN 1330314C CN B2004100003896 A CNB2004100003896 A CN B2004100003896A CN 200410000389 A CN200410000389 A CN 200410000389A CN 1330314 C CN1330314 C CN 1330314C
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ground
brain
west
cydiodine
iodine
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CN1640412A (zh
Inventor
王兴华
汪红华
胡红丰
汤贤孙
晏敏红
吴兰燕
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Zhejiang China Resources Sanjiu Zhongyi Pharmaceutical Co ltd
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ZHONGYI PHARMACEUTICAL INDUSTRY Co Ltd
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Abstract

本发明涉及一种西地碘口含片,该含片具有下列比例的组成:西地碘1.8-5%,西地脑1-8%,硬脂酸镁0.5-1%,糖粉或乳糖80-95%,羟丙甲基纤维素0.01-3%。本发明的西地碘口含片中不含枸橼酸成分,稳定性好,碘含量降低慢。

Description

西地碘口含片
发明领域
本发明涉及一种治疗口腔、咽喉疾病的西地碘含片(β-Cyelodextion Inclusion Compound of Iodine,简称西地碘,即碘的β-环糊精包合物)。
背景技术
口腔疾病(口腔溃疡、牙周炎、牙龈炎、冠周炎),咽喉部疾病(急、慢性咽炎、扁桃体炎)是临床常见病和多发病。碘作为消毒杀菌剂已逾一个世纪,它对各种细菌、真菌以及病毒均有无选择性的高效杀灭作用。多年来临床使用最多的“含碘喉症片”,没有解决制剂的稳定性问题。专利号为90106682.6的专利发明了西地碘口含片及其制备方法。该发明复方中各组分配比为:西地碘0.20-7.0%;薄荷脑0.1-1.0%;枸橼酸0.5-3.0;硬脂酸镁0.5-2.0%;蔗糖87.0-98.7%。与常用的碘制剂“碘含喉症片”相比,该专利制剂具有高效广谱的杀菌功能,而且用途广泛,疗效显著。
但是,我们经过反复实验,进一步发现:由于存在枸橼酸,该专利制剂碘含量下降较快,质量难以控制。因此我们用不含枸橼酸的配方做出了西地碘口含片。用不含枸橼酸的配方做出的西地碘口含片,碘含量下降较慢,质量稳定。由此完成了本发明。
发明目的
本发明提供了一种用于治疗口腔疾病的西地碘口含片,该西地碘口含片不含枸橼酸成分。
发明内容
本发明人经过长期反复研究,研制出一种不含枸橼酸的西地碘口含片,其组成为:
1、西地碘(也称CD碘)
2、西地脑(也称CD脑,即薄荷脑的β-环糊精包合物)
3、硬脂酸镁
4、糖粉或乳糖
5、粘合剂HPMC(HPMC即羟丙甲基纤维素)
该西地碘口含片的特点是不含枸橼酸成分,本发明人发现,正是因为本发明的西地碘口含片不含枸橼酸成分,本发明的西地碘口含片的碘含量下降慢,质量稳定,保质期长。
本发明的西地碘口含片具有下列重量比例的组成:
西地碘           1.8-5%
西地脑           1-8%
硬脂酸镁         0.5-1%
糖粉或乳糖       80-95%
羟丙甲基纤维素   0.01-3%
本发明的西地碘口含片不含枸橼酸成分,稳定性好,碘含量降低慢。
本发明的西地碘口含片含有薄荷脑,其具有驱风清凉调味、抗菌防腐的作用,但其极易挥发,影响产品的稳定性,故本发明中利用包合技术将薄荷脑使用β-CD(即β-环糊精)进行包合,形成薄荷脑的β-CD包合物(简称CD脑),增加了产品的稳定性。
西地脑作为本发明的一个重要组成部分,其重量比例如下:
薄荷脑:            5-25%
β-CD(即β-环糊精):75-95%
其制备工艺如下:
1、称取β-CD125克,置于1000毫升三口瓶中,加纯化水500毫升,于50-90℃水浴加热,搅拌使其全部溶解。
2、将薄荷脑研碎后,直接加入上述β-CD饱和液中,保温反应30分钟,自然降温,静置24小时。
3、用布氏漏斗抽滤至干,并用纯化水洗涤三次,在40-80℃下鼓风干燥,即得。
本发明优选的西地碘口含片的组成如下:
(1)西地碘:4.2g
(2)糖粉或乳糖:210g
(3)西地脑:18g
(4)硬脂酸镁:2.25g
(5)粘合剂:4%的羟丙甲基纤维素水溶液17ml。
下面通过实施例进一步说明本发明。应该理解的是,本发明的实施例是用于说明本发明而不是对本发明的限制。根据本发明的实质对本发明进行的简单改进都属于本发明要求保护的范围。除非另有说明,本发明中的百分数是重量百分数。
实施例
实施例1.含有枸橼酸的西地碘口含片的制备
组成:
西地碘:4.2g
糖粉:210g
西地脑:18g
柠檬酸(即枸橼酸):2.25g
硬脂酸镁:2.25g
粘合剂:4%的羟丙甲基纤维素水溶液17ml。
称取糖粉过80目筛,与西地碘用等量递加法混匀,将枸橼酸溶于3%的HPMC作粘合剂。通过制软材,制粒(用16目尼龙筛制粒二遍)。在60℃下干燥2-3个小时,用16目尼龙筛整粒,再加入处方量的CD脑,硬脂酸镁混匀即得。在检测含量后用φ11mm平冲压片,检验合格后,进行双铝包装。
实施例2.本发明西地碘口含片的制备
组成:
(1)西地碘:4.2g
(2)糖粉:210g
(3)西地脑:18g
(4)硬脂酸镁:2.25g
(5)粘合剂:4%的羟丙甲基纤维素水溶液17ml
操作步骤:除了不加枸橼酸之外,其他步骤与实施例1方法相同。
实施例3.实施例1和实施例2的西地碘口含片的稳定性试验在包装后,将实施例1和实施例2的西地碘口含片分别放在相同的条件下(T:37-40℃,RH:75%)进行0、1.2.3个月的碘含量加速试验考察。统计结果如下:
批号 0月碘含量(%) 三个月碘含量(%)
实验一 0307052 103.1 52.6
0307062 104.8 53.9
0307072 100.4 59.8
实验二 0307051 106.1 95.4
0307061 104.7 96.0
0307071 105.7 95.2
上述实验表明,枸橼酸对西地碘的稳定性具有重要影响。本发明的西地碘口含片中正因为是不含枸橼酸成分,因此,稳定性好,碘含量降低慢。

Claims (2)

1.一种西地碘口含片,其具有下列重量比例的组成:
西地碘         1.8-5%
西地脑         1-8%
硬脂酸镁       0.5-1%
糖粉或乳糖     89.3-95%
羟丙甲基纤维素 0.01-3%
其中:
西地脑的重量组成如下:
薄荷脑:     5-25%
β-环糊精    75-95%
西地脑制备工艺如下:
步骤1.称取β-环糊精125克,置于1000毫升三口瓶中,加纯化水500毫升,于50-90℃水浴加热,搅拌使其全部溶解;
步骤2.将薄荷脑研碎后,直接加入上述β-环糊精饱和液中,保温反应30分钟,自然降温,静置;
步骤3.用布氏漏斗抽滤至干,并用纯化水洗涤三次,在40-80℃下鼓风干燥即得。
2.根据权利要求1的西地脑口含片,其具有下列重量的组成:
西地碘:          4.2g
糖粉或乳糖:      210g
西地脑:          18g
硬脂酸镁:        2.25g
羟丙甲基纤维素    4%的水溶液17ml。
CNB2004100003896A 2004-01-13 2004-01-13 西地碘口含片 Expired - Lifetime CN1330314C (zh)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1049099A (zh) * 1990-08-16 1991-02-13 中国人民解放军军事医学科学院毒物药物研究所 复方西地碘口含片及其制备方法
CN1166340A (zh) * 1996-05-28 1997-12-03 中国人民解放军九五三三工厂 防治牙病药片制造工艺方法
CN1203792A (zh) * 1997-06-02 1999-01-06 张志宏 复方聚维酮碘口含片

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1049099A (zh) * 1990-08-16 1991-02-13 中国人民解放军军事医学科学院毒物药物研究所 复方西地碘口含片及其制备方法
CN1166340A (zh) * 1996-05-28 1997-12-03 中国人民解放军九五三三工厂 防治牙病药片制造工艺方法
CN1203792A (zh) * 1997-06-02 1999-01-06 张志宏 复方聚维酮碘口含片

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