Studies On The Quality Control Standard Of Burn Ointment

Objective: Burn ointment has a good clinical application as a hospital preparation. But it doesn’t have a clear quality standard that does not conform to the new requirement of hospital preparations and limits its application for hospital preparation.Studying the quality standard of burn ointment and establishing a draft of quality standard to effectively control the quality and make it conform to the relevant standards.Methods: Honeysuckle, forsythia, houttuynia cordata, borneolum syntheticum were identified by TLC. Gas chromatography was used to identify myrrh. Load and bacteria were checked according to the reference of Chinese pharmacopoeia. GC was used to determinate borneolum syntheticum and methyl nonyl ketone. HPLC was used to determinate chlorogenic acid.Results: In the study of TLC identification qualitative research, the TLC maps of honeysuckle, forsythia, houttuynia cordata were clear. They had a clear relationship and good reproducibility. The negative reference substances were out of interference. They can be involved in the preparation draft of quality standard. The TLC map of borneolum syntheticum did not have a clear relationship and the testing samples were not separated. It can’t be involved in the preparation draft of quality standard. The identification of myrrh by gas chromatography had a good resolution and specificity. But the identification method was not simple. It can also not be involved in the preparation draft of quality standard. The loaded quantity difference is controlled and asepsis check can be performed.Borneolum syntheticum had a good linear relationship within the range of 0.09506-2.3764 mg·ml-1. The average recovery was 98.9% and the relative standard deviation was 1.2%.The primary determination of borneolum syntheticum was 7.60 mg·g-1.Methyl nonyl ketone had a good linear relationship within the range of 0.01152～1.152 mg·ml-1. The average recovery was 99.1% and the relative standard deviation was 1.6%. The primary determination of methyl nonyl ketone was 0.105 mg·g-1.Chlorogenic acid had a good linear relationship within the range of 1.446～43.38 μg·ml-1. The average recovery was 97.6% and the relative standard deviation was 1.3%. The primary determination of chlorogenic acid was34.1μg·g-1.Conclusion: The draft of quality standard involves TLC identifications of honeysuckle, forsythia, houttuynia cordata and check projects of load, asepsis and determinations of methyl nonyl ketone, borneolum syntheticum. The draft can be used as quality standard of burn ointment. It conforms to the new requirement of hospital preparations.