Quality of control of compound chlorhexidine acetate ointment
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摘要: 目的 提高复方醋酸氯己定软膏的质量控制标准。 方法 增补处方中薄荷脑、樟脑的薄层色谱(TLC)法鉴别;建立高效液相色谱法同时测定处方中醋酸氯已定、盐酸丁卡因含量的方法。 结果 薄荷脑、樟脑薄层色谱斑点清晰,可用于鉴别;醋酸氯己定在10.01~160.14 μg/ml范围内线性关系良好,平均回收率为101.5%,RSD为1.8%;盐酸丁卡因在10.01~160.14 μg/ml范围内线性关系良好,平均回收率为100.5%,RSD为2.8%。 结论 提高后的质量标准可行。Abstract: Objective To improve the standard of the quality control of compound chlorhexidine acetate ointment. Methods TLC was used to control the quality of menthol crystal and camphor. A method to determine chlorhexidine acetate and cocaine hydrochloride simultaneously by HPLC was established. Results The spots of menthol crystal and camphor in TLC were clear. Chlorhexidine acetate and cocaine hydrochloride showed excellent linearity, which were at the range of 10.01-160.14 μg/ml and 10.01-160.14 μg/ml, respectively. The average recoveries were 101.5% (RSD=1.8%) and 100.5% (RSD=2.8%). Conclusion The methods were simple, sensitive and with good reproducibility and could be used to control the quality of compound chlorhexidine acetate ointment.
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Key words:
- compound chlorhexidine acetate ointment /
- TLC /
- HPLC
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