摘要
目的:制备消痘宁乳膏并建立其质量控制方法。方法:以单硬脂酸甘油酯等为基质,以盐酸克林霉素、甲硝唑为主药制备乳膏;采用高效液相色谱法分别测定其中2主药的含量;同时考察制剂放置6个月的稳定性。结果:所制乳膏质地均匀、细腻、黏稠度适宜;检查、鉴别均符合2005年版《中国药典》中的相关规定;盐酸克林霉素、甲硝唑进样量的线性范围分别为2.342～11.71μg(r=0.9998)、0.97～4.85μg(r=0.9998),平均回收率分别为98.3%(RSD=0.7%)、100.3%(RSD=1.6%)。稳定性试验中各检测指标未出现明显变化。结论:本制剂制备工艺简便可行,质量稳定可控。
OBJECTIVE： To prepare Xiaodouning cream and establish a method for its quality control. METHODS： The cream was prepared using glycerol monstearate as matrix with clindamycin hydrochloride and metronidazole as principle agents. The contents of the principal agents were determined by HPLC. The stability of the cream within 6 months was investigated. RESULTS： The cream was well- distributed and delicate with suitable viscidity, and it met the criteria of Chinese Pharma- copeia （2005 edition） in test and identification. The linear ranges of clindamycin hydrochloride and metronidazole were 2.342-- 11.71 p.g （ r = 0. 999 8） and 0.97-- 4.85μg （ r = 0. 999 8）, respectively, with average recoveries at 98.3 % （ RSD = 0.7% ） and 100.3% （RSD = 1.6% ）, respectively. In the stability test, no obvious change was noted for all indexes. CONCLUSION： The preparation technology of this cream is simple and feasible and its quality is stable and controllable.
出处
《中国药房》
CAS
CSCD
北大核心
2009年第34期2686-2688,共3页
China Pharmacy
