龙血竭涂膜剂制备工艺研究及临床应用
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摘要
目的探讨龙血竭涂膜剂的制作工艺,并评价其治疗褥疮的临床效果。方法采用正交试验,以聚乙烯醇、聚乙烯吡咯烷酮、药物质量、甘油量作为考察因素,涂膜剂的外观均匀性、柔韧性、耐热、耐寒及离心试验为考察指标,筛选涂膜剂最佳配比处方。临床褥疮实验,随机抽取一期褥疮患者60例,分为对照组和观察组,对照组外用医院敷料,观察组使用龙血竭涂膜剂,观察2组褥疮患者使用药物后创面恢复情况、治愈率和患者的出院时间。结果正交试验结果处方A1B3C3D3工艺涂膜剂基质评分最高,与其他处方相比,此处方亲肤性良好,成膜迅速,易剥离。观察组临床疗效、治愈率虽然高于对照组,但差异无统计学意义(P>0.05)。观察组出院率明显高于对照组,出院时间及药物起效时间短于对照组,差异均有统计学意义(P<0.05)。结论该涂膜剂的处方和制备工艺稳定可行,涂膜剂外观颜色均匀,涂布性良好,耐热、耐寒性试验制剂均无变化。临床实验中,龙血竭涂膜剂组对于褥疮治疗具有较好的效果。
Objective To prepare the Dragon′s blood gels and to investigate its clinical effect of the gels.Methods Orthogonal test was used.Polyvinyl alcohol,polyvinylpyrrolidone,drug quality and glycerol content were taken as the investigation factors.The appearance uniformity,flexibility,heat resistance,cold resistance and centrifugal test of the coating agent were taken as the indexes to select the best formulation of the coating agent.In the clinical experiment,60 bedsore patients were randomly divided into 2 groups,the control group(pharmaceutical dressing)and observation group(Dragon′s blood gels).The wound healing,cure rate and discharge time of 2 groups of patients with bedsore after medication were observed.Results Orthogonal test results showed that the formulation of A1 B3 C3 D3 film coating agent had the highest matrix score.Compared with other prescriptions,this prescription has good skin affinity,fast film formation and easy to peel off.The clinical efficacy and cure rate of the observation group were higher than those of the control group,but the difference was not statistically significant(P>0.05),The discharge rate of the observation group was significantly higher than the control group,the discharge time and drug effective time were shorter than the control group(P<0.05),which showed significant difference.Conclusion The preparation technology of Dragon′s blood gels is simple and the gel has good appearance and stability.Moreover,the Dragon′s blood gels have a good effect on bedsore patients.
Objective To prepare the Dragon′s blood gels and to investigate its clinical effect of the gels.Methods Orthogonal test was used.Polyvinyl alcohol,polyvinylpyrrolidone,drug quality and glycerol content were taken as the investigation factors.The appearance uniformity,flexibility,heat resistance,cold resistance and centrifugal test of the coating agent were taken as the indexes to select the best formulation of the coating agent.In the clinical experiment,60 bedsore patients were randomly divided into 2 groups,the control group(pharmaceutical dressing)and observation group(Dragon′s blood gels).The wound healing,cure rate and discharge time of 2 groups of patients with bedsore after medication were observed.Results Orthogonal test results showed that the formulation of A1 B3 C3 D3 film coating agent had the highest matrix score.Compared with other prescriptions,this prescription has good skin affinity,fast film formation and easy to peel off.The clinical efficacy and cure rate of the observation group were higher than those of the control group,but the difference was not statistically significant(P>0.05),The discharge rate of the observation group was significantly higher than the control group,the discharge time and drug effective time were shorter than the control group(P<0.05),which showed significant difference.Conclusion The preparation technology of Dragon′s blood gels is simple and the gel has good appearance and stability.Moreover,the Dragon′s blood gels have a good effect on bedsore patients.
引文
[1] 苏小琴,李曼曼,顾宇凡,等.龙血竭酚类成分研究[J].中草药,2014,45(11):1511-1514.
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[11] 肖立新,彭力平,马笃军,等.消瘀散涂膜剂和即型凝胶剂治疗急性软组织挫伤的实验研究[J].中华中医药学刊,2013,31(1):184-188.
[12] 金玲,王锦玉,仝燕,等.涂膜剂研究概述[J].中国实验方剂学,2012,18(8):277-280.
[13] 石永坚,程艳芹,李明春,等.正交设计法优选复方苦黄涂膜剂的基质组成[J].解放军药学学报,2014,30(2):122-124.
[14] 杨香华,陈咏敏,徐小芳.中药龙血竭应用于压疮患者的临床护理效果[J].新中医,2016,48(6):232-233.
[15] 王云云,王振宜.肛瘘手术镇痛机制及镇痛的研究进展[J].河北医科大学学报,2017,38(3):367-369.
[16] 陈莹璐,钟传篪,徐月,等.龙血竭胶囊合九华膏对环状混合痔术后创面促愈作用及对新生血管形成的影响[J].中国实验方剂学,2017,23(8):178-183.
[17] 刘建芳,薛改,李云霞,等.创伤涂膜剂对烫伤大鼠感染绿脓杆菌的治疗作用[J].解放军药学学报,2013,29(6):506-508.
[18] 马乃荣,陈梅,姜婷婷,等.龙血竭剂型的研究进展[J].当代医学,2017,23(31):175-177.
[2] 周密,徐晓勇,马凤森,等.雷公藤涂膜剂的制备及其体外透皮试验[J].中成药,2015,37(3):526-529.
[3] 庞露,陈志科,吕冠欣.复方丙酸氯倍他索涂膜剂的质控研究[J].中国药房,2013,24(5):435-437.
[4] 石聪,张兰春,余晓玲,等.龙血竭凝胶剂的制备及对创面组织的修复作用[J].中国实验方剂学杂志,2015,21(2):156-160.
[5] 王秀丽,魏忠梅,崔丽雅,等.压疮治疗护理新进展[J].河北医科大学学报,2013,34(1):117-119.
[6] 冯锐,王音,朱凤,等.Ento-Ⅰ涂膜剂的镇痛及其抗凝抗血栓形成作用[J].国际药学研究杂志,2016,43(3):509-519.
[7] 庞露,林耀坚,陈志科,等.复方苦参涂膜剂成膜材料及辅加剂的工艺研究[J].中药材,2014,37(4):694-697.
[8] 杨波,纪宏宇,车丽丽,等.复方延胡索涂膜剂成膜材料的优选[J].中国药师,2017,20(3):469-471.
[9] 张鹏,刘美欣,庞雅菊,等.中药“洗眼一号”涂膜剂的制备工艺研究[J].天津中医药,2016,33(7):437-439.
[10] 阙慧卿,陈洪,彭华毅,等.雷公藤内脂醇纳米脂质体涂膜剂制备研究[J].中草药,2016,47(20):3626-3631.
[11] 肖立新,彭力平,马笃军,等.消瘀散涂膜剂和即型凝胶剂治疗急性软组织挫伤的实验研究[J].中华中医药学刊,2013,31(1):184-188.
[12] 金玲,王锦玉,仝燕,等.涂膜剂研究概述[J].中国实验方剂学,2012,18(8):277-280.
[13] 石永坚,程艳芹,李明春,等.正交设计法优选复方苦黄涂膜剂的基质组成[J].解放军药学学报,2014,30(2):122-124.
[14] 杨香华,陈咏敏,徐小芳.中药龙血竭应用于压疮患者的临床护理效果[J].新中医,2016,48(6):232-233.
[15] 王云云,王振宜.肛瘘手术镇痛机制及镇痛的研究进展[J].河北医科大学学报,2017,38(3):367-369.
[16] 陈莹璐,钟传篪,徐月,等.龙血竭胶囊合九华膏对环状混合痔术后创面促愈作用及对新生血管形成的影响[J].中国实验方剂学,2017,23(8):178-183.
[17] 刘建芳,薛改,李云霞,等.创伤涂膜剂对烫伤大鼠感染绿脓杆菌的治疗作用[J].解放军药学学报,2013,29(6):506-508.
[18] 马乃荣,陈梅,姜婷婷,等.龙血竭剂型的研究进展[J].当代医学,2017,23(31):175-177.