CAJ | 학술논문

目的：制备复方醋酸氯己定凝胶，并建立其质量控制方法。方法：以醋酸氯己定、盐酸达克罗宁、薄荷脑、曲安奈德为主药，以甲基纤维素4500为基质制备凝胶；采用高效液相色谱法测定醋酸氯己定、盐酸达克罗宁的含量。结果：制备的凝胶均匀细腻，分散性好；醋酸氯己定浓度在0.08152～0.40760μg范围内呈良好的线性关系（r=0.9999，n=5），平均回收率为98.82%，RSD为1.19（n=9）；盐酸达克罗宁在0.1636～0.8180μg范围内呈良好的线性关系（r =0.9999， n =5），平均回收率为98.85%， RSD为1.13（n =9）。结论：本制剂组方合理，制备工艺简便可行，质量稳定可控。
목적：제비복방작산록기정응효，병건립기질량공제방법。방법：이작산록기정、염산체극라저、박하뇌、곡안내덕위주약，이갑기섬유소4500위기질제비응효；채용고효액상색보법측정작산록기정、염산체극라저적함량。결과：제비적응효균균세니，분산성호；작산록기정농도재0.08152～0.40760μg범위내정량호적선성관계（r=0.9999，n=5），평균회수솔위98.82%，RSD위1.19（n=9）；염산체극라저재0.1636～0.8180μg범위내정량호적선성관계（r =0.9999， n =5），평균회수솔위98.85%， RSD위1.13（n =9）。결론：본제제조방합리，제비공예간편가행，질량은정가공。
Objective: To prepare a compound chlorhexidine acetate gels and establish the quality contro1 meth-ods . Methods: The compound gels were prepared with chlorhexidine acetate , dyclonine hydrochloride , menthol and triamcinolone acetonide as the main components using methylcellulose 4500 as the stroma . HPLC method was used to determine the contents of chlorhexidine acetate dyclonine hydrochloride . Results: The gel preparation was even and fine and a good dispersivity . In the concentration range of 0 . 081 52 ~ 0 . 407 60 μg , chlorhexidine acetate had a lin-ear relationship (r=0.999 9, n=5), the average recovery was 98.82%, RSD=1.19%(n=9); In the concentration range of 0 . 163 6 ~ 0 . 818 0 μg , the dyclonine hydrochloride had a linear relationship ( r = 0 . 999 9 , n = 5 ) , the average recovery was 98 . 85%, RSD = 1 . 13%( n = 9 ) . Conclusion: The formulation of the gelata is reasonable and the production technology is simple and feasible , and the quality of preparation is stable and controllable .