CN112370438A - 一种氢溴酸右美沙芬透皮贴剂 - Google Patents
一种氢溴酸右美沙芬透皮贴剂 Download PDFInfo
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Abstract
一种氢溴酸右美沙芬透皮贴剂，包含载药层、背衬层和防粘层，所述载药层由氢溴酸右美沙芬、促渗剂和压敏胶基质组成。所述载药层中氢溴酸右美沙芬的重量百分比含量为2％～4％。所述载药层中促渗剂的重量百分比含量为1％～3％，所述促渗剂为重量比1：0.2～0.4：0.1～0.2的丙二醇、肉豆蔻酸和薄荷酮。所述压敏胶基质为聚硅氧烷压敏胶基质。
Description
技术领域
本发明涉及一种经皮给药制剂，尤其是涉及一种以氢溴酸右美沙芬为活性成分的透皮贴剂。
背景技术
氢溴酸右美沙芬(Dextromethorphan Hydrobromid)为中枢性镇咳药，主要抑制延脑的咳嗽中枢而发挥作用，作用与可待因相当，但无可待因的镇痛和镇静作用，无成瘾性，治疗剂量不会抑制呼吸中枢和呼吸道黏膜分泌。临床应用镇咳效果显著，不良反应发生率低，临床应用极为安全，具有服用剂量少而镇咳效果好的优点，被越来越广泛的用于镇咳治疗。现有的氢溴酸右美沙芬片剂的规格为15mg。但口服给药在人体内的生物半衰期仅为2.3小时，一天需要给药3-4次。在需要持续镇咳时，口服给药药物摄入较多，出现毒副作用的可能性较大。透皮贴剂作为一种经皮吸收制剂，可以通过皮肤贴敷给药，活性成分经皮肤吸收进入全身血液循环，可以延长作用时间，减少用药次数，用药方便，避免首过效应，减少胃肠道刺激。可以采用贴敷不同面积的透皮贴的方式，灵活调节给药剂量。因此提供一种氢溴酸右美沙芬透皮贴剂，以降低氢溴酸右美沙芬在用于持续镇咳治疗时的用量，并提高给药灵活性成为现有技术中亟待解决的问题。
发明内容
为解决前述技术问题，本发明采取的技术方案是：
提供了一种氢溴酸右美沙芬透皮贴剂，其特征是所述透皮贴剂包含载药层、背衬层和防粘层，所述载药层由氢溴酸右美沙芬、促渗剂和压敏胶基质组成。
所述的一种氢溴酸右美沙芬透皮贴剂，其特征是所述载药层中氢溴酸右美沙芬的重量百分比含量为2％～4％。
所述的一种氢溴酸右美沙芬透皮贴剂，其特征是所述载药层中促渗剂的重量百分比含量为1％～3％，所述促渗剂为重量比1：0.2～0.4：0.1～0.2的丙二醇、肉豆蔻酸和薄荷酮，所述丙二醇、肉豆蔻酸、和薄荷酮的重量比优选为1:0.2～0.3：0.15～0.2。
所述一种氢溴酸右美沙芬透皮贴剂，其特征是所述压敏胶基质为聚硅氧烷压敏胶基质。
所述一种氢溴酸右美沙芬透皮贴剂的制备方法，包括以下步骤：
1)将丙二醇、肉豆蔻酸和薄荷酮、氢溴酸右美沙芬和聚硅氧烷压敏胶基质混合均匀，涂布于防粘层上，于65-85℃干燥后再与背衬层复合，切割成贴剂，即得。
本发明提供的一种氢溴酸右美沙芬透皮贴剂，优选了丙二醇、肉豆蔻酸和薄荷酮作为促渗剂体系并优选了促渗剂的比例，以聚硅氧烷压敏胶基质，得到了一种氢溴酸右美沙芬透皮贴剂。本发明提供你的氢溴酸右美沙芬透皮贴，在贴敷使用时能够持续稳定释药，在用于持续镇咳时，可以减少药物总摄入量，降低副作用的发生。还可以通过贴敷不同面积的透皮贴，灵活调节用药量，满足镇咳治疗的实际需要。
具体实施方式
所有实施例中的百分比均为重量百分含量
实施例1
氢溴酸右美沙芬2％
促渗剂总用量1％，丙二醇、肉豆蔻酸和薄荷酮的重量比为1：0.2：0.1；余量的聚硅氧烷压敏胶基质，
配制方法如下
1)将丙二醇、肉豆蔻酸和薄荷酮、氢溴酸右美沙芬和聚硅氧烷压敏胶基质混合均匀，涂布于防粘层上，于65-85℃干燥后再与背衬层复合，切割成贴剂，即得。
实施例2
氢溴酸右美沙芬3％
促渗剂总用量2％，丙二醇、肉豆蔻酸和薄荷酮的重量比为1：0.4：0.2；余量的聚硅氧烷压敏胶基质，
配制方法如下
1)将丙二醇、肉豆蔻酸和薄荷酮、氢溴酸右美沙芬和聚硅氧烷压敏胶基质混合均匀，涂布于防粘层上，于65-85℃干燥后再与背衬层复合，切割成贴剂，即得。
实施例3
氢溴酸右美沙芬4％
促渗剂总用量3％，丙二醇、肉豆蔻酸和薄荷酮的重量比为1：0.2：0.15；余量的聚硅氧烷压敏胶基质，
配制方法如下
1)将丙二醇、肉豆蔻酸和薄荷酮、氢溴酸右美沙芬和聚硅氧烷压敏胶基质混合均匀，涂布于防粘层上，于65-85℃干燥后再与背衬层复合，切割成贴剂，即得。
实施例4
氢溴酸右美沙芬3％
促渗剂总用量2％，丙二醇、肉豆蔻酸和薄荷酮的重量比为1：0.3：0.15；余量的聚硅氧烷压敏胶基质配制方法如下
1)将丙二醇、肉豆蔻酸和薄荷酮、氢溴酸右美沙芬和聚硅氧烷压敏胶基质混合均匀，涂布于防粘层上，于65-85℃干燥后再与背衬层复合，切割成贴剂，即得。。
实施例5
氢溴酸右美沙芬3％
促渗剂总用量2％，丙二醇、肉豆蔻酸和薄荷酮的重量比为1：0.2：0.2；余量的聚硅氧烷压敏胶基质，
配制方法如下
1)将丙二醇、肉豆蔻酸和薄荷酮、氢溴酸右美沙芬和聚硅氧烷压敏胶基质混合均匀，涂布于防粘层上，于65-85℃干燥后再与背衬层复合，切割成贴剂，即得。
通过对实施例1～5的贴剂进行考察，可知其含量均匀度、释放度、初黏力、持黏力、和剥离强度均符合中国药典2015版二部附录IV贴剂中的相关规定。
药理实施例1一种氢溴酸右美沙芬透皮贴剂的体外经皮渗透实验。
采用立式扩散池，有效扩散面积为2.8cm2，所用皮肤为去毛猪耳朵皮肤，皮肤厚度约为约600μm。将贴剂贴于去毛猪耳朵皮肤的角质层一侧，置于扩散池与接收池之间，角质层朝向扩散池，真皮层朝向接收池。接收池体积为6.5mL，加满pH7.4PBS并排除气泡，置于循环水浴磁力搅拌池中，磁子转速设为300r/min，水浴温度为37℃。透皮开始后第2h、4h、6h、8h、10h、12h、14h、24h取样1mL，取样后立即补充新鲜的接收液，将取样液用0.45μm微孔滤膜滤过后用高效液相色谱法测定氢溴酸右美沙芬的浓度，计算经皮渗透速率和累积渗透量，结果如下表所示(means±SD，n＝3)
| 组别 | 经皮渗透速率(μg<sup>.</sup>cm-2.h<sup>-1</sup>) | 累计渗透量(μg<sup>.</sup>cm<sup>-2</sup>) |
| 实施例1 | 0.52±0.14 | 8.85±0.87 |
| 实施例2 | 0.61±0.12 | 9.21±0.92 |
| 实施例3 | 0.73±0.15 | 12.19±1.04 |
| 实施例4 | 0.85±0.12 | 14.57±0.98 |
| 实施例5 | 0.87±0.11 | 15.36±1.24 |
实验结果表明，本发明提供的透皮贴剂，在优选了压敏胶基质和促渗剂的情况下，能够实现氢溴酸右美沙芬的体外透皮给药。
Claims (5)
1.一种氢溴酸右美沙芬透皮贴剂，其特征是所述透皮贴剂包含载药层、背衬层和防粘层，所述载药层由氢溴酸右美沙芬、促渗剂和压敏胶基质组成。
2.如权利要求1所述的一种氢溴酸右美沙芬透皮贴剂，其特征是所述载药层中氢溴酸右美沙芬的重量百分比含量为2％～4％。
3.如权利要求2所述的一种氢溴酸右美沙芬透皮贴剂，其特征是所述载药层中促渗剂的重量百分比含量为1％～3％，所述促渗剂为重量比1：0.2～0.4：0.1～0.2的丙二醇、肉豆蔻酸和薄荷酮。
4.如权利要求3所述的一种氢溴酸右美沙芬透皮贴剂，其特征是所述丙二醇、肉豆蔻酸、和薄荷酮的重量比为1:0.2～0.3：0.15～0.2。
5.如权利要求1～4任一所述一种氢溴酸右美沙芬透皮贴剂，其特征是所述压敏胶基质为聚硅氧烷压敏胶基质。
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| CN202011366521.0A Pending CN112370438A (zh) | 2020-11-30 | 2020-11-30 | 一种氢溴酸右美沙芬透皮贴剂 |
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Application publication date: 20210219 |