摘要
目的 探索将关节粘连外洗方的外用洗剂剂型转变为凝胶贴膏,优选凝胶贴膏的最佳基质处方。方法 初步拟定凝胶贴膏的5种关键基质,对聚丙烯酸钠NP700、甘羟铝、羧甲基纤维素钠(CMC-Na)、聚乙烯醇(PVA)、甘油这5种用量,进行单因素分析,并以成型贴膏的初黏力、持黏力、剥离强度等为考察指标进行判定。结果 从单因素考察中发现,当NP700合理用量范围在2%~15%,用量过低则膏体过软难以成型,无法涂布。当甘羟铝合理用量范围在0.03%~0.25%,用量增高则导致贴膏的初黏力和内聚力增高、剥离强度减少。当CMC-Na合理用量范围在0.5%~10%,随用量水平提高,则导致贴膏的初黏力明显增加和内聚力剥离强度减弱。当PVA合理用量范围在1%~6%,用量减少时贴膏不能成型,用量增多时贴膏初黏力增加、内聚力减弱。当甘油合理用量范围在28%~33%,用量过低则膏体偏硬,涂布出现硬块,用量过高则膏体过软,出现溢膏。结论 5种基质辅料均会对贴膏的各项指标造成明显影响,且作用并不相同,用量范围最终确定为:NP700(2%~15%)、甘羟铝(0.07%~0.25%)、CMC-Na(0.5%~10%)、PVA(1%~6%)、甘油(23%~33%)。
Objective To explore how to transform the external lotion form of joint adhesion prescription into gel plaster,and optimize the optimal matrix formula of gel plaster.Methods Five key matrices for gel plasters were preliminarily determined,including NP700,aluminum glycyrrhizinate,CMC-Na,PVA,and glycerin.Single factor analysis was conducted using the above five matrices.The initial adhesion,adhesion holding force,and peel strength of gel pastes were used as quality observation indicators.Results From a single factor investigation,it is found that when the reasonable dosage of NP700 is between 2%-15%,if the dosage is too low,the paste is too soft to be molded and cannot be coated.When the reasonable dosage of aluminum glyoxylate ranges from 0.03%-0.25%,the higher the dosage,the higher the initial adhesion and cohesion of the plaster,and the lower the peel strength.When the reasonable dosage of CMC-Na is in the range of 0.5%-10%,with the increase of the dosage level,the initial adhesion of the plaster will increase significantly and the cohesive peel strength will decrease.When the reasonable dosage of PVA is in the range of 1%-6%,the paste cannot be formed when the dosage is reduced,and the initial viscosity of the paste increases and the cohesion decreases when the dosage is increased.When the reasonable dosage of glycerin is in the range of 28%-33%,if the dosage is too low,the paste will be hard,and there will be lumps in the coating.Conclusions The five matrix excipients will have a significant impact on the indexes of the plaster,and the mechanism is not the same.The dosage range of the five matrix excipients was finally determined as follows:NP700(2%-15%),aluminum glycolium(0.07%-0.25%),CMC-Na(0.5%-10%),PVA(1%-6%),glycerol(23%-33%).
作者
李海涛
王辉
LI Haitao;WANG Hui(Department of Pharmacy,Beijing Fengsheng Traditional Chinese Medicine Orthopedics and Traumatology Hospital,Beijing 100031,China;Department of Biomedical,Beijing City University,Beijing 100094,China)
出处
《中国医药指南》
2024年第19期91-94,共4页
Guide of China Medicine
