CN113662916A - 一种儿童用镇静剂及其制备方法 - Google Patents
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Abstract
本发明提供一种儿童用镇静剂及其制备方法,属于医药领域。所述儿童用镇静剂(水合氯醛溶液),原料包括下述物质:水合氯醛原料药、油脂类溶剂,其中水合氯醛原料药与油脂类溶剂的质量比可为:10‑32:68‑90,具体可为10:90、20:80或30:70;所述油脂类溶剂可选自:大豆油、玉米油、葵花籽油、茶油、芝麻油、橄榄油、花生油、中链甘油三酸脂、甘油三乙酯、油酸油酯、油酸的一种或多种,具体可为质量比10:1的大豆油与葵花籽油的混合物;所述儿童用镇静剂还可进一步包括维生素E。本发明用油脂类溶剂替代水制备儿童用镇静剂(水合氯醛溶液),油脂类溶剂对水合氯醛有较好的溶解度,且能保证水合氯醛的稳定性,维生素E的加入进一步增强了水合氯醛的稳定性。
Description
技术领域
本发明涉及一种儿童用镇静剂及其制备方法,属于医药领域。
背景技术
水合氯醛是三氯乙醛的水合物,是一种催眠药、抗惊厥药,为白色或无色透明的结晶;有刺激性,特臭,味微苦;在空气中渐渐挥发。具有镇静、催眠和抗惊厥作用。催眠机理可能与巴比妥类相似,引起近似生理性睡眠,无明显后作用。较大剂量有抗惊厥作用,大剂量可引起昏迷和麻醉。水合氯醛不易在体内蓄积中毒,常用量无毒性作用。刺激性强,应稀释后应用。
目前,在临床上的主要用途有1.治疗失眠,适用于入睡困难的患者。作为催眠药,短期应用有效,连续服用超过两周则无效。2.麻醉前、手术前和睡眠脑电图检查前用药,可镇静和解除焦虑,使相应的处理过程比较安全和平稳。3.抗惊厥,用于癫癎持续状态的治疗,也可用于小儿高热、破伤风及子癎引起的惊厥。
水合氯醛小剂量产生镇静,较大剂量引起睡眠,通常服药后分钟即可入睡,醒后无不适感,不易产生蓄积中毒,临床上很多检查操作时需要患儿保持安静,儿童特别是婴幼儿由于恐惧等原因,清醒状态下多不能配合,因此临床常使用水合氯醛对患儿进行镇静,是儿科临床上广泛应用中枢镇静药物,尤其是在保证婴幼儿中的各项检查中起了重要作用。
水合氯醛溶液的稳定性受贮存时间、贮存条件及温度的影响,应避免光照及长期贮存,宜低温贮存,现用现配(刘佳,姜清华,杨跃辉,水合氯醛溶液稳定性考察),水合氯醛在临床上给儿童使用时需要根据体重调整给药剂量,但因其自身稳定性不好,导致制药企业无法按药品技术要求开发口服溶液剂,因此考虑开发具有能满足稳定性要求,且可灵活调整剂量的溶液剂。
发明内容
本发明的目的是提供一种儿童用镇静剂(水合氯醛溶液)及其制备方法。
本发明所提供的儿童用镇静剂(水合氯醛溶液),其原料包括下述物质:水合氯醛原料药、油脂类溶剂,
其中水合氯醛原料药与油脂类溶剂的质量比可为:10-32:68-90,具体可为10:90、20:80或30:70;
所述油脂类溶剂可选自:大豆油、玉米油、葵花籽油、茶油、芝麻油、橄榄油、花生油、中链甘油三酸脂、甘油三乙酯、油酸油酯、油酸中的一种或多种,具体可为质量比10:1的大豆油与葵花籽油的混合物;
进一步地,所述儿童用镇静剂(水合氯醛溶液)还可进一步包括维生素E,维生素E与水合氯醛原料药的质量比可为0.1:10-30;
具体地,所述儿童用镇静剂(水合氯醛溶液),由1)-13)中任一项所述的质量份的原料制成:
1)大豆油:水合氯醛原料药:维生素E=89.9g:10g:0.1g或79.9g:20g:0.1g或69.9g:30g:0.1g;
2)玉米油:水合氯醛原料药:维生素E=89.9g:10g:0.1g或79.9g:20g:0.1g;
3)葵花籽油:水合氯醛原料药:维生素E=89.9g:10g:0.1g或79.9g:20g:0.1g或69.9g:30g:0.1g;
4)茶油:水合氯醛原料药:维生素EE=89.9g:10g:0.1g;
5)中链甘油三脂:水合氯醛原料药:维生素E=69.9g:30g:0.1g;
6)大豆油:水合氯醛原料药=22.5g:2.5g或20g:5g或18.6g:8g;
8)大豆油、葵花籽油:水合氯醛原料药:维生素E=81.73g:8.17g:10g:0.1g或72.64g:7.26g:20g:0.1g或63.55g:6.35g:30g:0.1g;
9)大豆油、葵花籽油:水合氯醛原料药:维生素E=85g:4.9g:10g:0.1g;
10)大豆油、葵花籽油:水合氯醛原料药:维生素E=89g:0.9g:10g:0.1g;
11)大豆油、葵花籽油:水合氯醛原料药:维生素E=50g:39.9g:10g:0.1g;
12)大豆油、茶油:水合氯醛原料药:维生素E=81.73g:8.17g:10g:0.1g;
13)大豆油、橄榄油:水合氯醛原料药:维生素E=81.73g:8.17g:10g:0.1g;
上述儿童用镇静剂(水合氯醛溶液)通过包括如下步骤的方法制备得到:将油脂类溶剂与水合氯醛原料药加入到烧杯后在加热状态下搅拌溶解,即得。
进一步地,将油脂类溶剂、维生素E与水合氯醛原料药一同加入到烧杯后在加热状态下搅拌溶解,即得。
本发明具有以下优点:本发明用油脂类溶剂替代水制备儿童用镇静剂(水合氯醛溶液),油脂类溶剂对水合氯醛有较好的溶解度,且能保证水合氯醛的稳定性,维生素E的加入进一步增强了水合氯醛的稳定性。另外,本发明制得的浓度为20%、30%的水合氯醛溶液无强烈气味,儿童服药顺应性好。
具体实施方式
下述实施例中所使用的实验方法如无特殊说明,均为常规方法。
下述实施例中所用的材料、试剂等,如无特殊说明,均可从商业途径得到。
本发明提供一种儿童用镇静剂(水合氯醛溶液),其原料包括下述物质:水合氯醛原料药、油脂类溶剂,
其中水合氯醛原料药与油脂类溶剂的质量比可为:10-32:68-90,具体可为10:90、20:80或30:70;
所述油脂类溶剂可选自:大豆油、玉米油、葵花籽油、茶油、芝麻油、橄榄油、花生油、中链甘油三酸脂、甘油三乙酯、油酸油酯、油酸中的一种或多种,具体可为质量比10:1的大豆油与葵花籽油的混合物;
进一步地,所述儿童用镇静剂(水合氯醛溶液)还可进一步包括维生素E,维生素E与水合氯醛原料药的质量比可为0.1:10-30;
具体地,所述儿童用镇静剂(水合氯醛溶液),由1)-13)中任一项所述的质量份的原料制成:
1)大豆油:水合氯醛原料药:维生素E=89.9g:10g:0.1g或79.9g:20g:0.1g或69.9g:30g:0.1g;
2)玉米油:水合氯醛原料药:维生素E=89.9g:10g:0.1g或79.9g:20g:0.1g;
3)葵花籽油:水合氯醛原料药:维生素E=89.9g:10g:0.1g或79.9g:20g:0.1g或69.9g:30g:0.1g;
4)茶油:水合氯醛原料药:维生素EE=89.9g:10g:0.1g或79.9g:20g:0.1g或69.9g:30g:0.1g;
5)中链甘油三脂:水合氯醛原料药:维生素E=69.9g:30g:0.1g;
6)橄榄油:水合氯醛原料药=22.5g:2.5g或20g:5g或18.6g:8g;
7)芝麻油:水合氯醛原料药=22.5g:2.5g;
8)大豆油、葵花籽油:水合氯醛原料药:维生素E=81.73g:8.17g:10g:0.1g或72.64g:7.26g:20g:0.1g或63.55g:6.35g:30g:0.1g;
9)大豆油、葵花籽油:水合氯醛原料药:维生素E=85g:4.9g:10g:0.1g;
10)大豆油、葵花籽油:水合氯醛原料药:维生素E=89g:0.9g:10g:0.1g;
11)大豆油、葵花籽油:水合氯醛原料药:维生素E=50g:39.9g:10g:0.1g;
12)大豆油、茶油:水合氯醛原料药:维生素E=81.73g:8.17g:10g:0.1g;
13)大豆油、橄榄油:水合氯醛原料药:维生素E=81.73g:8.17g:10g:0.1g;
上述儿童用镇静剂(水合氯醛溶液)通过包括如下步骤的方法制备得到:将油脂类溶剂与水合氯醛原料药加入到烧杯后在加热状态下搅拌溶解,即得。
进一步地,将油脂类溶剂、维生素E与水合氯醛原料药一同加入到烧杯后在加热状态下搅拌溶解,即得。
实施例1、
以大豆油:水合氯醛原料药:维生素E=89.9g:10g:0.1g为原料制备质量浓度10%的水合氯醛溶液;
实施例2、
以大豆油:水合氯醛原料药:维生素E=79.9g:20g:0.1g为原料制备质量浓度20%的水合氯醛溶液;
实施例3、
以大豆油:水合氯醛原料药:维生素E=69.9g:30g:0.1g为原料制备质量浓度30%的水合氯醛溶液;
实施例4、
以玉米油:水合氯醛原料药:维生素E=89.9g:10g:0.1g为原料制备质量浓度10%的水合氯醛溶液;
实施例5、
以玉米油:水合氯醛原料药:维生素E=79.9g:20g:0.1g为原料制备质量浓度20%的水合氯醛溶液;
实施例6、
以葵花籽油:水合氯醛原料药:维生素E=89.9g:10g:0.1g为原料制备质量浓度10%的水合氯醛溶液;
实施例7、
以葵花籽油:水合氯醛原料药:维生素E=79.9g:20g:0.1g为原料制备质量浓度20%的水合氯醛溶液;
实施例8、
以葵花籽油:水合氯醛原料药:维生素E=69.9g:30g:0.1g为原料制备质量浓度30%的水合氯醛溶液;
实施例9、
以茶油:水合氯醛原料药:维生素EE=89.9g:10g:0.1g为原料制备质量浓度10%的水合氯醛溶液;
实施例10、
以中链甘油三脂:水合氯醛原料药:维生素E=69.9g:30g:0.1g为原料制备质量浓度10%的水合氯醛溶液;
实施例11、
以大豆油:水合氯醛原料药=22.5g:2.5g为原料制备质量浓度10%的水合氯醛溶液;
实施例12、
以大豆油:水合氯醛原料药=20g:5g为原料制备质量浓度20%的水合氯醛溶液;
实施例13、
以大豆油:水合氯醛原料药=18.6g:8g为原料制备质量浓度30%的水合氯醛溶液;
实施例14、
以大豆油、葵花籽油:水合氯醛原料药:维生素E=81.73g:8.17g:10g:0.1g为原料制备质量浓度10%的水合氯醛溶液;
实施例15、
以大豆油、葵花籽油:水合氯醛原料药:维生素E=72.64g:7.26g:20g:0.1g为原料制备质量浓度20%的水合氯醛溶液;
实施例16、
以大豆油、葵花籽油:水合氯醛原料药:维生素E=63.55g:6.35g:30g:0.1g为原料制备质量浓度30%的水合氯醛溶液;
实施例17、
以大豆油、葵花籽油:水合氯醛原料药:维生素E=85g:4.9g:10g:0.1g为原料制备质量浓度10%的水合氯醛溶液;
实施例18、
以大豆油、葵花籽油:水合氯醛原料药:维生素E=89g:0.9g:10g:0.1g为原料制备质量浓度10%的水合氯醛溶液;
实施例19、
以大豆油、葵花籽油:水合氯醛原料药:维生素E=50g:39.9g:10g:0.1g为原料制备质量浓度10%的水合氯醛溶液;
实施例20、
以大豆油、茶油:水合氯醛原料药:维生素E=81.73g:8.17g:10g:0.1g为原料制备质量浓度10%的水合氯醛溶液;
实施例21、
以大豆油、橄榄油:水合氯醛原料药:维生素E=81.73g:8.17g:10g:0.1g为原料制备质量浓度10%的水合氯醛溶液。
对上述实施例1-21制得的水合氯醛溶液进行稳定性测试
用以下方法测定含量:
HPLC方法
流动相:0.01mol/L磷酸二氢钾(磷酸调节pH值至3.0)-乙腈(88:12)
流速:1.0ml/min
检测波长:210nm
柱温:25℃
进样体积:20μl
采集时间:15min
色谱柱:Ultiamte XB-C18 4.6*150mm 5μm
溶剂:流动相
1.溶液配制方式
对照品溶液:称取对照品约50mg置25ml量瓶,加溶剂超声溶解,放冷,溶剂稀释至刻度摇匀即得。
供试品溶液:称取供试品适量(约相当于含水合氯醛50mg)置25ml量瓶,加流动相置涡旋混合器上涡旋2min,溶剂稀释至刻度,摇匀,滤过,弃去初滤液2ml,取续滤液即得。
稳定性结果
由上表可以看出,用油脂类溶剂取代水制得的水合氯醛溶液稳定性明显提高,其中以质量比10:1的大豆油与葵花籽油的混合物为溶剂制得的水合氯醛溶液稳定性最佳,维生素E的添加进一步提高了溶液的稳定性。
Claims (6)
1.一种儿童用镇静剂,水合氯醛溶液,其原料包括下述物质:水合氯醛原料药、油脂类溶剂,
其中,水合氯醛原料药与油脂类溶剂的质量比为:10-32:68-90。
2.根据权利要求1所述的儿童用镇静剂,其特征在于:所述油脂类溶剂选自:大豆油、玉米油、葵花籽油、茶油、芝麻油、橄榄油、花生油、中链甘油三酸脂、甘油三乙酯、油酸油酯、油酸中的一种或多种。
3.根据权利要求2所述的儿童用镇静剂,其特征在于:所述油脂类溶剂为质量比10:1的大豆油与葵花籽油的混合物。
4.根据权利要求1-3中任一项所述的儿童用镇静剂,其特征在于:所述儿童用镇静剂还包括维生素E,维生素E与水合氯醛原料药的质量比为0.1:10-30。
5.制备权利要求1-3中任一项所述的儿童用镇静剂的方法,包括:将油脂类溶剂与水合氯醛原料药加入到烧杯后在加热状态下搅拌溶解,即得。
6.制备权利要求4所述的儿童用镇静剂的方法,包括:将油脂类溶剂、维生素E与水合氯醛原料药一同加入到烧杯后在加热状态下搅拌溶解,即得。
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Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
GB709283A (en) * | 1951-07-02 | 1954-05-19 | Fellows Medical Mfg Company In | Gelatine capsules containing chloral hydrate |
FR2624012A1 (fr) * | 1987-12-07 | 1989-06-09 | Fdb Ste Civile Rech | Nouvelles compositions pharmaceutiques a action hypnotique a base d'hydrate de chloral |
US20090297617A1 (en) * | 2002-07-05 | 2009-12-03 | Collegium Pharmaceuticals Inc. | Abuse-deterrent pharmaceutical compositions of opioids and other drugs |
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Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
GB709283A (en) * | 1951-07-02 | 1954-05-19 | Fellows Medical Mfg Company In | Gelatine capsules containing chloral hydrate |
FR2624012A1 (fr) * | 1987-12-07 | 1989-06-09 | Fdb Ste Civile Rech | Nouvelles compositions pharmaceutiques a action hypnotique a base d'hydrate de chloral |
US20090297617A1 (en) * | 2002-07-05 | 2009-12-03 | Collegium Pharmaceuticals Inc. | Abuse-deterrent pharmaceutical compositions of opioids and other drugs |
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