CN114533655A - 一种改良的磺胺嘧啶锌银霜及其制备方法 - Google Patents
一种改良的磺胺嘧啶锌银霜及其制备方法 Download PDFInfo
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Abstract
本发明涉及一种改良的磺胺嘧啶锌银霜及其制备方法,属于药物制备技术领域。本发明所述改良的磺胺嘧啶锌银霜包括以下质量份的制备用原料:磺胺嘧啶锌200~700份、磺胺嘧啶银200~600份,地榆150份,黄芪100~400份,白及100~300份,虎杖300~600份,生理盐水3000份,薄荷冰10~50份,冰片50~330份,体积百分含量为75%的乙醇水溶液200~400份和乳膏基质40000份。本发明所述改良的磺胺嘧啶锌银霜疗效好,易操作,能够使患者的烧伤疼痛程度降低、创面愈合时间缩短、愈合后瘢痕发生情况减少及皮肤色素沉着脱失情况减弱,且能够减少创面铜绿假单胞菌感染发生率,同时减少磺胺嘧啶银的不良反应。
Description
技术领域
本发明涉及药物制备技术领域,具体涉及一种改良的磺胺嘧啶锌银霜及其制备方法。
背景技术
烧(烫)伤为临床急诊突发性皮肤热损伤,多见于突发事件或严重的灾难性成批人员受伤,如治疗不当易诱发感染,引起并发症,致残或致多脏器损伤而危及生命。由局部感染引起的脓毒血症、败血症是引起烧伤病人死亡的主要原因。防治烧伤创面感染,局部抗菌药物的应用有其重要的临床价值。目前治疗烧(烫)伤的外用药物大多为油剂、吸附力差、且需要反复多次清创换药、对创面刺激性大、愈合慢、容易感染。磺胺嘧啶银是常用局部抗感染制剂,但对伤口有较强烈的刺激,有使创面损害加重的风险。目前临床上并没有一种疗效高、易操作、市场前景广阔的治疗烧(烫)伤的理想外用中药。
发明内容
本发明的目的在于提供一种改良的磺胺嘧啶锌银霜及其制备方法。本发明所述改良的磺胺嘧啶锌银霜疗效好,易操作,能够使患者的烧伤疼痛程度降低、创面愈合时间缩短、愈合后瘢痕发生情况减少及皮肤色素沉着脱失情况减弱,且能够减少创面铜绿假单胞菌感染发生率,同时减少磺胺嘧啶银的不良反应。
本发明提供了一种改良的磺胺嘧啶锌银霜,包括以下质量份的制备用原料:磺胺嘧啶锌200~700份、磺胺嘧啶银200~600份,地榆150份,黄芪100~400份,白及100~300份,虎杖300~600份,生理盐水3000份,薄荷冰10~50份,冰片50~330份,体积百分含量为75%的乙醇水溶液200~400份和乳膏基质40000份。
优选的是,所述磺胺嘧啶锌银霜包括以下质量份的制备用原料:磺胺嘧啶锌280份、磺胺嘧啶银260份,地榆150份,黄芪250份,白及200份,虎杖400份,生理盐水3000份,薄荷冰10份,冰片200份,体积百分含量为75%的乙醇水溶液300份和乳膏基质40000份。
优选的是,所述乳膏基质的制备用原料包括石蜡油,无水羊毛脂,十六醇,吐温-80,司盘,甘油,防腐剂,抗氧剂和蒸馏水。
本发明还提供了上述技术方案所述磺胺嘧啶锌银霜的制备方法,包括以下步骤:
将研磨后的薄荷冰和冰片与体积百分含量为75%的乙醇水溶液混合,得到含薄荷冰与冰片的乙醇水溶液;
将乳膏基质加热溶化,得到熔化的乳膏基质;
将磺胺嘧啶银和磺胺嘧啶锌混悬于生理盐水后与熔化的乳膏基质混合,得到第一混合后乳膏基质;
将地榆、虎杖、黄芪和白及进行水煎,去渣浓缩,得到中药膏,将中药膏与第一混合后乳膏基质混合,得到第二混合后乳膏基质;
将含薄荷冰与冰片的乙醇水溶液与第二混合后乳膏基质混合,得到磺胺嘧啶锌银霜。
本发明提供了一种改良的磺胺嘧啶锌银霜。本发明改良的磺胺嘧啶锌银霜优化了锌粉和银粉的投药量,减少了磺胺嘧啶银的用量,并增加了镇静、收敛功效,增强了止痛和促进皮肤愈合等功能。与现有产品相比较,磺胺嘧啶锌:磺胺嘧啶银=4:3的比例效果更佳,总量比市售产品少30~40%,能够减少磺胺嘧啶银的副作用,同时用黄芪和白及增加促进皮肤肌肉再生之功,虎杖收敛、止血、抗菌,地榆促进创面微血管生成,薄荷、冰片镇静止痛,可缩短愈合时间,减少病人痛苦。本发明所述改良的磺胺嘧啶锌银霜疗效好,易操作,能够使患者的烧伤疼痛程度降低、创面愈合时间缩短、愈合后瘢痕发生情况减少及皮肤色素沉着脱失情况减弱,且能够减少创面铜绿假单胞菌感染发生率,同时减少磺胺嘧啶银的不良反应。
本发明改良的磺胺嘧啶锌银霜减少了银粉的用量,降低了银对机体的不良反应,同时加入筛选的中药,增加了该制剂抗菌消肿,促进皮肤愈合的效果。
附图说明
图1为本发明提供的市售药品治疗前后对比图;
图2为本发明提供的改良磺胺嘧啶锌银霜治疗前后图片。
具体实施方式
本发明提供了一种改良的磺胺嘧啶锌银霜,包括以下质量份的制备用原料:磺胺嘧啶锌200~700份、磺胺嘧啶银200~600份,地榆150份,黄芪100~400份,白及100~300份,虎杖300~600份,生理盐水3000份,薄荷冰10~50份,冰片50~330份,体积百分含量为75%的乙醇水溶液200~400份和乳膏基质40000份。本发明改良的磺胺嘧啶锌银霜优化了锌粉和银粉的投药量,减少了磺胺嘧啶银的用量,并增加了镇静、收敛功效,增强了止痛和促进皮肤愈合等功能。与现有产品相比较,磺胺嘧啶锌:磺胺嘧啶银=4:3的比例效果更佳,总量比市售产品少30~40%,能够减少磺胺嘧啶银的副作用,同时用虎杖、地榆、黄芪和白及促进创面愈合之功,薄荷、冰片镇静止痛,可缩短愈合时间,减少病人痛苦。
本发明所述改良的磺胺嘧啶锌银霜包括200~700份的磺胺嘧啶锌,更优选为280份。在本发明中,所述磺胺嘧啶锌为粉末状。本发明对所述磺胺嘧啶锌的来源没有特殊限定,采用本领域技术人员熟知的磺胺嘧啶锌的常规市售产品即可。本发明的锌盐能破坏细菌的DNA结构和促进上皮细胞生长,具有控制感染和促进愈合的双重功能。
本发明所述改良的磺胺嘧啶锌银霜包括200~600份的磺胺嘧啶银,更优选为260份。在本发明中,所述磺胺嘧啶银为粉末状。本发明对所述磺胺嘧啶银的来源没有特殊限定,采用本领域技术人员熟知的磺胺嘧啶银的常规市售产品即可。本发明通过银离子取代细菌DNA中的氢键,使细菌不能分裂和繁殖。
本发明所述改良的磺胺嘧啶锌银霜包括150份的地榆。本发明对所述地榆的来源没有特殊限定,采用本领域技术人员熟知的地榆的常规市售产品即可。本发明地榆具有清热解毒、祛瘀生肌之功,能够促进创面微血管生成。
本发明所述改良的磺胺嘧啶锌银霜包括100~400份的黄芪,更优选为250份。本发明对所述黄芪的来源没有特殊限定,采用本领域技术人员熟知的黄芪的常规市售产品即可。黄芪改善创面微循环,充实肉芽组织,促进组织修复和创面愈合。
本发明所述改良的磺胺嘧啶锌银霜包括100~300份的白及,更优选为200份。本发明对所述白及的来源没有特殊限定,采用本领域技术人员熟知的白及的常规市售产品即可。白及可促进创面愈合。
本发明所述改良的磺胺嘧啶锌银霜包括300~600份的虎杖,更优选为400份。本发明对所述虎杖的来源没有特殊限定,采用本领域技术人员熟知的虎杖的常规市售产品即可。本发明所述虎杖能够收敛止血、抗菌消炎,有利于创面愈合。
本发明所述改良的磺胺嘧啶锌银霜包括3000份的生理盐水。在本发明中,所述生理盐水为质量百分含量为0.9%的氯化钠水溶液。本发明对所述生理盐水的来源没有特殊限定,采用本领域技术人员熟知的生理盐水的常规市售产品即可。本发明所述生理盐水用于作为缓冲溶液制备磺胺嘧啶银粉和磺胺嘧啶锌粉混悬液,同时不影响患处的生理环境。
本发明所述改良的磺胺嘧啶锌银霜包括10~50份的薄荷冰,更优选为10份。本发明对所述薄荷冰的来源没有特殊限定,采用本领域技术人员熟知的薄荷冰的常规市售产品即可。本发明所述薄荷冰有镇静止痛的功效,能够缓解病人的症状。
本发明所述改良的磺胺嘧啶锌银霜包括50~330份的冰片,更优选为200份。本发明对所述冰片的来源没有特殊限定,采用本领域技术人员熟知的冰片的常规市售产品即可。本发明所述冰片能清热止痛,开窍醒神,能够缓解病人疼痛症状。
本发明所述改良的磺胺嘧啶锌银霜包括200~400份的体积百分含量为75%的乙醇水溶液,更优选为300份。本发明对所述乙醇水溶液的来源没有特殊限定,采用本领域技术人员熟知的常规方法进行制备即可。本发明应用乙醇水溶液将薄荷冰和冰片溶解,进而将溶液与乳膏基质混匀。
本发明所述改良的磺胺嘧啶锌银霜包括40000份的乳膏基质。在本发明中,所述乳膏基质的制备用原料优选包括石蜡油,无水羊毛脂,十六醇,吐温-80,司盘,甘油,防腐剂,抗氧剂和蒸馏水。本发明所述乳膏基质为油包水型乳膏,性质稳定,乳膏基质作为本制剂药物的载体,富有黏性,能保持创面湿润,使组织维持正常修复功能,隔绝外界刺激和污染,防御病原体侵犯,利于创面修复和再生。本发明对所述乳膏基质的来源没有特殊限定,采用本领域技术人员熟知的乳膏基质的常规市售产品即可,如购自广东恒健制药有限公司。
本发明还提供了上述技术方案所述磺胺嘧啶锌银霜的制备方法,包括以下步骤:
将研磨后的薄荷冰和冰片与体积百分含量为75%的乙醇水溶液混合,得到含薄荷冰与冰片的乙醇水溶液;
将乳膏基质加热溶化,得到熔化的乳膏基质;
将磺胺嘧啶银和磺胺嘧啶锌混悬于生理盐水后与熔化的乳膏基质混合,得到第一混合后乳膏基质;
将地榆、虎杖、黄芪和白及进行水煎,去渣浓缩,得到中药膏,将中药膏与第一混合后乳膏基质混合,得到第二混合后乳膏基质;
将含薄荷冰与冰片的乙醇水溶液与第二混合后乳膏基质混合,得到磺胺嘧啶锌银霜。
在本发明中,所述水煎优选为将地榆、虎杖、黄芪和白及与水混合,煎煮1h后去渣浓缩至膏状。本发明所述中药膏与第一混合后乳膏基质混合后,优选搅拌后冷却,得到磺胺嘧啶锌银霜。
下面结合具体实施例对本发明所述的一种改良的磺胺嘧啶锌银霜及其制备方法做进一步详细的介绍,本发明的技术方案包括但不限于以下实施例。
实施例1
按照磺胺嘧啶锌300份、磺胺嘧啶银400份,黄芪100份,白及100份,地榆150份,虎杖350份,生理盐水3000份,薄荷冰50份,冰片100份,体积百分含量为75%的乙醇水溶液200份和乳膏基质40000份的比例,称取磺胺嘧啶锌300g、磺胺嘧啶银400g,黄芪100g,白及100g,地榆150g,虎杖350g,生理盐水3000g,薄荷冰50g,冰片100g,体积百分含量为75%的乙醇水溶液200g和乳膏基质40000g。
将研磨后的薄荷冰和冰片与体积百分含量为75%的乙醇水溶液混合;
将乳膏基质加热溶化,得到熔化的乳膏基质;
将磺胺嘧啶银和磺胺嘧啶锌混悬于生理盐水后与熔化的乳膏基质乳膏基质混合,
将地榆、虎杖、黄芪、白及加水2kg后于一般铝锅内煎煮1小时后去渣浓缩至膏状,加入基质内,搅拌后冷却,再将薄荷冰与冰片的乙醇溶液加入基质,得到磺胺嘧啶锌银霜。
实施例2
按照磺胺嘧啶锌600份、磺胺嘧啶银500份,黄芪350份,白及300份,地榆150份,虎杖500份,生理盐水3000份,薄荷冰30份,冰片200份,体积百分含量为75%的乙醇水溶液200份和乳膏基质40000份的比例称取磺胺嘧啶锌600g、磺胺嘧啶银500g,黄芪350g,白及300g,地榆150g,虎杖500g,生理盐水3000g,薄荷冰30g,冰片200g,体积百分含量为75%的乙醇水溶液200g和乳膏基质40000g。
将研磨后的薄荷冰和冰片与体积百分含量为75%的乙醇水溶液混合;
将乳膏基质加热溶化,得到熔化的乳膏基质;
将磺胺嘧啶银和磺胺嘧啶锌混悬于生理盐水后与熔化的乳膏基质乳膏基质混合,
将地榆、虎杖、黄芪、白及加水2kg后于一般铝锅内煎煮1小时后去渣浓缩至膏状,加入基质内,搅拌后冷却,再将薄荷冰与冰片的乙醇溶液加入基质,得到磺胺嘧啶锌银霜。
实施例3
按照磺胺嘧啶锌280份、磺胺嘧啶银260份,黄芪250份,白及200份,地榆150份,虎杖400份,生理盐水3000份,薄荷冰10份,冰片200份,体积百分含量为75%的乙醇水溶液200份和乳膏基质40000份的比例称取磺胺嘧啶锌280g、磺胺嘧啶银260g,黄芪250g,白及200g,地榆150g,虎杖400g,生理盐水3000g,薄荷冰10g,冰片200g,体积百分含量为75%的乙醇水溶液200g和乳膏基质40000g。
将研磨后的薄荷冰和冰片与体积百分含量为75%的乙醇水溶液混合;
将乳膏基质加热溶化,得到熔化的乳膏基质;
将磺胺嘧啶银和磺胺嘧啶锌混悬于生理盐水后与熔化的乳膏基质乳膏基质混合,将地榆、虎杖、黄芪、白及加水2kg后于一般铝锅内煎煮1小时后去渣浓缩至膏状,加入基质内,搅拌均匀后冷却,再将薄荷冰与冰片的乙醇溶液加入基质,得到磺胺嘧啶锌银霜。
质量控制
1性状:本品为白色膏状物
2稳定性考察
2.1离心试验:取实施例1~3所述样品各10g,置于带刻度的离心管中,以2500r/min离心30min,结果霜剂无分层现象。
2.2留样观察:取实施例1~3所述样品各20g,于室温((25±5)℃)下,放置3分钟测试,鉴别检查,其外观、性状均无变化。
2.3耐热、耐寒试验:取实施例1~3所述样品各20g,置于53℃恒温箱内6h和-20℃冰箱内24h观察,结果样品均无异常现象。
3卫生学标准
依据中《中国药典》附录XIJ检查,符合规定。
4刺激性实验
选择2.5kg~3.0kg的健康家兔6只,剃去背毛2.5cm×2cm,休息6h,各部位均用本品1.0g均匀涂布,2次/d,共3d,结果无红肿、糜烂现象。
实施例4
方法:随机选择2017年6月至2019年5月使用本产品治疗烧伤创面的患者共92例,其中住院患者42例,门诊患者50例。其中男性60例,女性患者32例。年龄区间为23岁~78岁,机分为3组,本发明改良方组,市售药品(批号:201703,厂家:广东恒健制药有限公司)组,常规治疗组(给予生理盐水或双氧水清理创面,去除异物,若有未破损的水疱用无菌注射器针头刺破,完全引流水疱液。若出现创面感染则根据细菌培养及药敏结果进行抗感染治疗)。
诊断标准依据中华医学会编著《临床诊疗指南烧伤外科学分册》(2007年版)制定。①烧伤面积的估计:采用中国九分法和手掌法两种方法相配合的方式进行烧伤面积估计。②烧伤深度判断:采用四度五分法的组织学划分。将体表面积的5%≤烧伤总面积<体表面积的30%,烧伤创面表皮有水疱或表皮浮动,掀开浮动表皮后创面基底红润潮湿,定义为浅二度。
治疗方法
各组给予生理盐水清洗创面,去除异物,保留水疱疱皮,若有未破损的水疱用无菌注射器针头刺破,完全引流水疱液。若出现创面感染(创面有脓性分泌物、创面周围红肿,机体发热)时,根据细菌培养及药敏结果进行抗感染治疗,然后分别给药,市售药品组和改良药品组患者给予市售磺胺嘧啶锌银霜和改良磺胺嘧啶锌银霜涂布,用无菌纱布包扎或暴露,1次/d。给药之前,各组均以0.1%新洁尔灭溶液清洁消毒创面。
疗效标准
疗效按治愈、好转、未愈3级标准评定。治愈:创面愈合90%以上;不再需植皮。有效:创面愈合70%~90%;无全身症状;化验检查无重要项目异常;不再需植皮。无效:创面愈合50%以下或未愈;并发败血症等未好转;多处创面瘢痕形成,影响功能者还需植皮。
统计方法:计数资料以率(%)表示,采用卡方检验和秩和检验,计量资料用均数标准差表示,组间比较采用t检验。
治疗效果
总有效率比较:临床疗效观察结果见表1。改良磺胺嘧啶霜和市售药品的总有效率均达到100%,两组之间比较无显著统计学差异。
表1两组患者临床疗效观察结果
与对照组比较,*P<0.05。
创面愈合情况见表2。改良磺胺嘧啶霜组和市售磺胺嘧啶霜组(批号:201703,厂家:广东恒健制药有限公司)患者使用止痛药的例数、瘢痕发生率和皮肤色素沉着或脱失例数均显著低于对照组(P>0.05,而改良磺胺嘧啶霜组创面愈合情况较市售磺胺嘧啶霜组更优,但无统计学差异(P>0.05)。各组创面愈合时间无统计学差异。
表2创面愈合情况
与对照组比较,*P<0.05。
两组患者治疗情况相较结果见表3。与治疗前比较,各组创面疼痛评分均显著减低,各组之间比较无统计学差异。
表3创面疼痛评分比较(视觉模拟评分法,VAS)
与对照组比较,*P<0.05。与同组治疗前比较,#P<0.05,##P<0.01。
图1为市销磺胺嘧啶霜治疗前后对比,可以看出治疗后期大部分创面已愈合,但仍有很多未愈合创面散在分布,且这些未愈合创面具有迁延难愈,反复破溃的特点。
图2为改良磺胺嘧啶霜治疗前后对比,可以看出治疗后期创面愈合好,未出现散在分布未愈合创面的情况。
以上所述仅是本发明的优选实施方式,应当指出,对于本技术领域的普通技术人员来说,在不脱离本发明原理的前提下,还可以做出若干改进和润饰,这些改进和润饰也应视为本发明的保护范围。
Claims (4)
1.一种改良的磺胺嘧啶锌银霜,其特征在于,包括以下质量份的制备用原料:磺胺嘧啶锌200~700份、磺胺嘧啶银200~600份,地榆150份,黄芪100~400份,白及100~300份,虎杖300~600份,生理盐水3000份,薄荷冰10~50份,冰片50~330份,体积百分含量为75%的乙醇水溶液200~400份和乳膏基质40000份。
2.根据权利要求1所述的磺胺嘧啶锌银霜,其特征在于,所述磺胺嘧啶锌银霜包括以下质量份的制备用原料:磺胺嘧啶锌280份、磺胺嘧啶银260份,地榆150份,黄芪250份,白及200份,虎杖400份,生理盐水3000份,薄荷冰10份,冰片200份,体积百分含量为75%的乙醇水溶液300份和乳膏基质40000份。
3.根据权利要求1或2所述的磺胺嘧啶锌银霜,其特征在于,所述乳膏基质的制备用原料包括石蜡油、无水羊毛脂、十六醇、吐温-80、司盘、甘油、防腐剂、抗氧剂和蒸馏水。
4.权利要求1~3任一项所述磺胺嘧啶锌银霜的制备方法,包括以下步骤:
将研磨后的薄荷冰和冰片与体积百分含量为75%的乙醇水溶液混合,得到含薄荷冰与冰片的乙醇水溶液;
将乳膏基质加热溶化,得到熔化的乳膏基质;
将磺胺嘧啶银和磺胺嘧啶锌混悬于生理盐水后与熔化的乳膏基质混合,得到第一混合后乳膏基质;
将地榆、虎杖、黄芪和白及进行水煎,去渣浓缩,得到中药膏,将中药膏与第一混合后乳膏基质混合,得到第二混合后乳膏基质;
将含薄荷冰与冰片的乙醇水溶液与第二混合后乳膏基质混合,得到磺胺嘧啶锌银霜。
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