CN114601793A - 一种氨溴特罗口服溶液及其制备方法 - Google Patents
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Abstract
本发明公开了一种氨溴特罗口服溶液及其制备方法,包括:盐酸克仑特罗0.0001g,盐酸氨溴索0.15g,防腐剂0.20g,稳定剂2.90‑3.20g,甘油8.00g,甜味剂18.50‑24.50g,增稠剂0.23‑0.26g,pH调节剂0.04g,抗氧化剂0.10g,矫味剂0.15‑0.20g,纯化水余量。制备方法:将甘油和增稠剂混合搅拌;防腐剂、甜味剂、25%纯化水在80℃条件下搅拌30min,然后冷却备用;将稳定剂、抗氧化剂、盐酸氨溴索、盐酸克仑特罗、pH调节剂、矫味剂、65%纯化水与前述步骤的物料混合搅拌30min;用余量纯化水定容,循环搅拌过滤;灌装;成品;外包装。溶剂采用甘油、水,稳定剂采用丙二醇,增稠剂采用羟乙纤维素,配以科学的工艺参数生产,获得稳定性佳的口服液,加入用量合适的甜味剂、矫味剂能够改善药物服用风味、口感体验,利于病人服用。
Description
技术领域
本发明涉及一种药物制剂技术领域,尤其涉及氨溴特罗。
背景技术
氨溴特罗口服溶液,用于治疗急、慢性呼吸道疾病(如急、慢性支气管炎,支气管哮喘,肺气肿等)引起的咳嗽、痰液粘稠、排痰困难、喘息等。其中的盐酸氨溴索为黏液溶解药,能增加呼吸道黏膜浆液腺的分泌,减少黏液腺分泌,降低痰液黏度,促进肺表面活性物质的分泌,增加支气管纤毛运动,使痰液易于咳出,其另一功效成分盐酸克仑特罗为选择性β受体激动药,有松弛支气管平滑肌,增强纤毛运动、溶解黏液,促进痰液排出的作用。氨溴特罗口服溶液因其治疗效果佳具有广泛的应用,但是其药物的储存稳定性以及药物服用气味、口感等体验还需要有所提高。
发明内容
本发明的目的在于提供一种氨溴特罗口服溶液及其制备方法,以解决药物储存稳定性以及药物服用气味、口感体验提升的问题。
为了达到上述目的本发明采用如下技术方案:
一种氨溴特罗口服溶液,按100mL溶液计,包括如下成分:
盐酸克仑特罗0.0001g,盐酸氨溴索0.15g,防腐剂0.20g,稳定剂2.90-3.20g,甘油8.00g,甜味剂18.50-24.50g,增稠剂0.23-0.26g,pH调节剂0.04g,抗氧化剂0.10g,矫味剂0.15-0.20g,纯化水余量。
进一步地,按100mL溶液计,包括如下成分:
盐酸克仑特罗0.0001g,盐酸氨溴索0.15g,防腐剂0.20g,稳定剂3.20g,甘油8.00g,甜味剂24.50g,增稠剂0.26g,pH调节剂0.04g,抗氧化剂0.10g,矫味剂0.20g,纯化水余量。
进一步地,所述防腐剂是苯甲酸钠;
稳定剂是丙二醇;
甜味剂是山梨醇;
增稠剂是羟乙纤维素;
pH调节剂是DL酒石酸;
抗氧化剂是亚硫酸氢钠;
矫味剂是香精。
本发明还提供一种所述的氨溴特罗口服溶液的制备方法,步骤包括:
(1)将甘油和增稠剂混合搅拌10min;
(2)防腐剂、甜味剂、25%纯化水在80℃条件下搅拌30min,然后冷却至50℃以下备用;
(3)将稳定剂、抗氧化剂、盐酸氨溴索、盐酸克仑特罗、pH调节剂、矫味剂、65%纯化水与步骤(1)、(2)的物料混合搅拌30min;
(4)用余量纯化水定容,循环搅拌30min、60min、90min;
(5)过滤;
(6)灌装;
(7)成品;
(8)外包装。
本发明的优点包括:溶剂采用甘油、水,稳定剂采用丙二醇,增稠剂采用羟乙纤维素,配以科学的工艺参数进行生产,能够获得稳定性佳的口服液,另外加入用量合适的甜味剂、矫味剂能够改善药物服用风味、口感体验,利于病人服用。
具体实施方式
下面将结合具体实施例来详细说明本发明,在此以本发明的示意性实施例及说明用来解释本发明,但并不作为对本发明的限定。
实施例一
一种氨溴特罗口服溶液,按100mL溶液计,包括如下成分:
盐酸克仑特罗0.0001g,盐酸氨溴索0.15g,防腐剂0.20g,稳定剂2.90g,甘油8.00g,甜味剂24.50g,增稠剂0.23g,pH调节剂0.04g,抗氧化剂0.10g,矫味剂0.20g,纯化水余量。
所述防腐剂是苯甲酸钠;
稳定剂是丙二醇;
甜味剂是山梨醇;
增稠剂是羟乙纤维素;
pH调节剂是DL酒石酸;
抗氧化剂是亚硫酸氢钠;
矫味剂是香精。
本发明还提供一种所述的氨溴特罗口服溶液的制备方法,步骤包括:
(1)将甘油和增稠剂混合搅拌10min;
(2)防腐剂、甜味剂、25%纯化水在80℃条件下搅拌30min,然后冷却至50℃以下备用;
(3)将稳定剂、抗氧化剂、盐酸氨溴索、盐酸克仑特罗、pH调节剂、矫味剂、65%纯化水与步骤(1)、(2)的物料混合搅拌30min;
(4)用余量纯化水定容,循环搅拌30min、60min、90min;
(5)过滤;
(6)灌装;
(7)成品;
(8)外包装。
实施例二
一种氨溴特罗口服溶液,按100mL溶液计,包括如下成分:
盐酸克仑特罗0.0001g,盐酸氨溴索0.15g,防腐剂0.20g,稳定剂3.20g,甘油8.00g,甜味剂24.50g,增稠剂0.26g,pH调节剂0.04g,抗氧化剂0.10g,矫味剂0.20g,纯化水余量。
制备方法同实施例一。
实施例三
一种氨溴特罗口服溶液,按100mL溶液计,包括如下成分:
盐酸克仑特罗0.0001g,盐酸氨溴索0.15g,防腐剂0.20g,稳定剂3.20g,甘油8.00g,甜味剂18.50g,增稠剂0.26g,pH调节剂0.04g,抗氧化剂0.10g,矫味剂0.20g,纯化水余量。
制备方法同实施例一。
以上对本发明实施例所提供的技术方案进行了详细介绍,本文中应用了具体个例对本发明实施例的原理以及实施方式进行了阐述,以上实施例的说明只适用于帮助理解本发明实施例的原理;同时,对于本领域的一般技术人员,依据本发明实施例,在具体实施方式以及应用范围上均会有改变之处,综上所述,本说明书内容不应理解为对本发明的限制。
Claims (4)
1.一种氨溴特罗口服溶液,其特征在于:
按100mL溶液计,包括如下成分:
盐酸克仑特罗0.0001g,盐酸氨溴索0.15g,防腐剂0.20g,稳定剂2.90-3.20g,甘油8.00g,甜味剂18.50-24.50g,增稠剂0.23-0.26g,pH调节剂0.04g,抗氧化剂0.10g,矫味剂0.15-0.20g,纯化水余量。
2.根据权利要求1所述的一种氨溴特罗口服溶液,其特征在于:
按100mL溶液计,包括如下成分:
盐酸克仑特罗0.0001g,盐酸氨溴索0.15g,防腐剂0.20g,稳定剂3.20g,甘油8.00g,甜味剂24.50g,增稠剂0.26g,pH调节剂0.04g,抗氧化剂0.10g,矫味剂0.20g,纯化水余量。
3.根据权利要求1或2所述的一种氨溴特罗口服溶液,其特征在于:
所述防腐剂是苯甲酸钠;
稳定剂是丙二醇;
甜味剂是山梨醇;
增稠剂是羟乙纤维素;
pH调节剂是DL酒石酸;
抗氧化剂是亚硫酸氢钠;
矫味剂是香精。
4.一种权利要求1-3任一所述的氨溴特罗口服溶液的制备方法,其特征在于:
步骤包括:
(1)将甘油和增稠剂混合搅拌10min;
(2)防腐剂、甜味剂、25%纯化水在80℃条件下搅拌30min,然后冷却至50℃以下备用;
(3)将稳定剂、抗氧化剂、盐酸氨溴索、盐酸克仑特罗、pH调节剂、矫味剂、65%纯化水与步骤(1)、(2)的物料混合搅拌30min;
(4)用余量纯化水定容,循环搅拌30min、60min、90min;
(5)过滤;
(6)灌装;
(7)成品;
(8)外包装。
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Cited By (3)
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CN115350150A (zh) * | 2022-09-23 | 2022-11-18 | 海门普适医药有限公司 | 一种稳定的氨溴特罗口服溶液及其制备方法 |
CN115645366A (zh) * | 2022-11-15 | 2023-01-31 | 山东济坤生物制药有限公司 | 一种氨溴特罗口服溶液及其制备工艺 |
CN116440074A (zh) * | 2023-05-26 | 2023-07-18 | 浙江高跖医药科技股份有限公司 | 一种氯化钾口服制剂及其制备方法 |
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Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
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CN115350150A (zh) * | 2022-09-23 | 2022-11-18 | 海门普适医药有限公司 | 一种稳定的氨溴特罗口服溶液及其制备方法 |
CN115645366A (zh) * | 2022-11-15 | 2023-01-31 | 山东济坤生物制药有限公司 | 一种氨溴特罗口服溶液及其制备工艺 |
CN116440074A (zh) * | 2023-05-26 | 2023-07-18 | 浙江高跖医药科技股份有限公司 | 一种氯化钾口服制剂及其制备方法 |
CN116440074B (zh) * | 2023-05-26 | 2024-02-20 | 浙江高跖医药科技股份有限公司 | 一种氯化钾口服制剂及其制备方法 |
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