对《中国药典》2015年版一部含雄黄制剂标准的建议

Suggestion on standard for preparations containing realgar in Chinese Pharmacopoeia (2015 edition Volume Ⅰ)

目的完善《中国药典》2015年版一部含雄黄制剂的标准。方法对《中国药典》2015年版一部收载的含雄黄制剂标准中雄黄相关项目进行统计分析。结果《中国药典》2015年版一部共收载含雄黄的制剂37个,在质量标准正文中雄黄炮制、雄黄鉴别、三氧化二砷限量检查、雄黄含量测定及注意等项目中存在一些问题。结论提出完善含雄黄制剂标准的建议。

Objective To improve the standard for preparations containing realgar in Chinese Pharmacopoeia（ 2015 edition Volume Ⅰ）. Methods The seleted items of realgar-containing preparation standard in Chinese Pharmacopoeia（ 2015 edition Volume Ⅰ） were analyzed statistically. Results There were 37 preparations containing realgar in Chinese Pharmacopoeia（ 2015 edition Volume Ⅰ）. There were some problems in the quality standard text, including processing and identification of realgar, limit test of arsenic trioxide,determination of realgar content and attention items.Conclusion Suggestions on improvement of standard of preparations containing realgar.