复方四黄双水凝胶的成型工艺优化、抑菌效果和表征结构研究

Formulation Process and Antibacterial Effect of Compound Sihuang Hydrogel

目的:研究中山市中医院的中药外用制剂复方四黄外洗液的剂型改造,探讨复方中药复合水凝胶成型工艺优化。方法:采用正交试验法,以人工皮肤专用膜作为透皮试验介质,通过体外透皮试验,选取经皮渗透液中的小檗碱与黄芩苷的含量为指标;通过抑菌实验,以复方四黄双水凝胶对金黄色葡萄球菌的抑菌圈大小为指标,综合二者指标数据,对复方四黄双水凝胶的成型工艺进行优化;最后通过抑菌试验,选金黄色葡萄球菌、大肠杆菌和铜绿假单胞菌为考察对象,对比四黄外洗液及最佳工艺四黄双水凝胶二者的抑菌效果。最后采用扫描电子显微镜观察分析双水凝胶、卡波姆、海藻酸钠的表征结构。结果:复方四黄双凝胶的最佳配方为6%海藻酸钠、0.3%卡波姆、10%丙二醇及3%氮酮。三种致病菌抑菌实验中,四黄外洗液及凝胶剂二者对金黄色葡萄球菌抑菌效果最强,前者抑菌圈直径(14.5 mm)略强于后者(13.5 mm),对大肠杆菌具有微弱抑制效果,对铜绿假单胞菌无抑制作用,二者的抑菌效果相近,双扫描电镜观察得,双凝胶具有比海藻酸钠结构排列规律更细腻的多孔结构,又有卡波的光滑和丝状体特性。结论:该成型工艺及研究方法合理,稳定可行,可为复方四黄凝胶剂的进一步研究开发提供参考,四黄外洗液及凝胶剂对金黄色葡萄球菌敏感,双凝胶拥有海藻酸钠和卡波相表征结构。

Objective:To study the dosage form modification of the Chinese medicinal preparation of compound Sihuang external lotion in Zhongshan City Hospital of Traditional Chinese Medicine,and to develop compound Sihuang hydrogel by combining compound Sihuang external lotion with hydrogel as the matrix,and to investigate its forming process and antibacterial effect to meet the different needs in clinical use.Methods:Through reviewing the literature and relevant pre-experiments,the types and contents of the matrix required for the gel were initially selected,and through the investigation of the sensory index,stability and antibacterial effect of the gel,the blank gel matrix with the best combination of Sihuang solution was screened to determine the best drug loading capacity of the compound Sihuang hydrogel;Using the orthogonal test method,artificial membrane was used as the transdermal test medium,and the transdermal permeation was selected through in vitro transdermal test.The content of berberine hydrochloride and baicalin in the transdermal permeation fluid was selected as the index;and the size of the inhibition circle of Staphylococcus aureus was selected as the index by the inhibition test.The data of the two indicators were combined to determine the best formulation of the compound Sihuang hydrogel.Results:Carbomer/sodium alginate composite blank gel was the most ideal,and it was determined as the gel matrix of Sihuang external lotion;the optimal drug loading was 1.5 times;the optimal formulation was 6% sodium alginate,0.3% carbomer,10% propylene glycol and 3% nitrogen ketone.In the final antibacterial experiment,the two of Sihuang external wash and gel had the strongest effect on Staphylococcus aureus,and the former had a slightly stronger inhibition circle diameter(14.5 mm)than the latter(13.5 mm),and had a weak inhibition effect on Escherichia coli,and no inhibition effect on Pseudomonas aeruginosa.Conclusion:The molding process and research method are reasonable,stable and feasible,which can provide reference for further research and development of compound Sihuang hydrogel.Sihuang external lotion and gel were sensitive to staphylococcus aureus.