复方克霉唑凝胶剂的制备工艺及其抗菌活性研究

Preparation and Antibacterial Activity of Compound Clotrimazole Gel

目的探讨复方克霉唑凝胶剂的制备工艺并研究其抗菌活性。方法以卡波姆-940、主药总量、凝胶pH值为因素和以综合评分为考察指标运用L9(34)正交实验方法对复方克霉唑凝胶剂的制备工艺进行研究,并对制备出的克霉唑凝胶剂进行皮肤组织学抗菌实验。结果复方克霉唑凝胶剂最佳制备工艺为:克霉唑3.0 g,尿素20 g,二甲基亚砜17 mL,甘油11 mL,卡波姆-940 1.5 g,吐温-80 1.0 g,三乙醇胺调节pH值到6.50,最后纯化水加至200 g;生理盐水组合赋性剂组在10天内愈合的创口较少,复方凝胶剂组合达克宁组在7天内创口全部愈合,与生理盐水组比较有显著性差异(P<0.05)。结论复方克霉唑凝胶剂制备工艺凝胶成型效果较佳,方法稳定可靠,可用于进一步工艺扩大生产,此外制备出的复方克霉唑凝胶剂抗菌活性显著。

Objective To study the preparation and antibacterial activity of compound clotrimazole gel. Methods The preparation of compound elotrimazole gel was studied by L9 （3^4 ） orthogonal test, with earbomer - 940, the total dosage of main drug, gel pH as the factors and the comprehensive score as the index. The effect of compound clotrimazole gels was e- valuated by antibacterial experiment in skin histology. Results The optimum preparation was achieved with clotrimazole 3.0 g, urea 20 g, dimethyl sulfoxide 17 mL, glycerin 11 mL carbomer -940 1.5 g, Tween -80 1.0 g, triethanolamine to adjust pH to 6. 50 and purified water 200 g. The wounds were healed within 7 days when treated with compound gel combined with daktarin, and the wounds treated treated with saline combined with excipient got healed within 10 days. The difference was significant in healing time between the two groups （ P 〈 0. 05 ）. Conclusion The preparation of compound clotrimazole gel is better, with stable and feasible methods, so it can be used to further expand the production. In addition, the compound clot- rimazole gel has significant antibacterial activity.