Abstract：Objective To study the stability of Compound Camphor Cream. Methods Triamcinolone acetate in Compound Camphor Cream was determined by high performance liquid chromatography with methanol∶ 0.2% aqueous phosphate∶ ether (60∶38∶2) as mobile phase, shvmadzu chromatographic column (4.6 mm×150 mm, 5 μm) at a wavelength of 239 nm. High temperature, strong light, acceleration, and long-term tests were carried out under the same chromatographic conditions according to the Chinese pharmacopoeia standards. Thin layer chromatography was used to identify camphor and menthol in compound camphor cream. Results Triamcinolone acetate showed a good linear relationship (r=0.999) between 0.23-1.15 μg, RSD of precision were 0.19 %, RSD of stability were 0.12 %, RSD of repeatability were 0.09 %, average recovery was 100.05%, RSD of 0.95 % (n=9). The thin layer chromatographic spots of camphor and menthol in the cream were clear, Rf value was moderate, negative without interference. The product was placed at high temperature (40±2)℃ and strong light (4 500±500) Lx for ten days. The appearance, character and content of the preparation all met the regulations. The quality of the preparation was stable after accelerated test and long-term test. Conclusion Compound Camphor Cream has good stability.
任洁 闫晓兰 谢六生. 复方樟脑乳膏稳定性试验研究[J]. 中国医药导报, 2023, 20(19): 35-39.
REN Jie YAN Xiaolan XIE Liusheng. Study on stability of Compound Camphor Cream. 中国医药导报, 2023, 20(19): 35-39.
京公网安备 11010502046598号