医院制剂养胃膏的质控方法探讨

Discuss for Quality Control Methods of Hospital Preparation YangWei Oral Paste

目的建立医院制剂养胃膏的薄层鉴别方法及相对密度、水分检查限量范围,探讨养胃膏的质控方法。方法根据《中国药典》2020版四部通则,建立养胃膏的薄层定性鉴别方法,并根据试验结果确定相对密度、水分限量检查范围。结果建立的养胃膏薄层色谱鉴别方法重现性和专属性良好,其中黄芪甲苷薄层鉴别的定量限0.1 mg·mL^(-1);丹参酮ⅡA薄层鉴别的定量限0.2 mg·mL^(-1)。制定的相对密度、水分等内控标准可以较好的体现养胃膏的内控质量。结论建立的养胃膏薄层鉴别方法操作简便,方法可靠,供试液中标示成分均能显色清晰,达到定量限的最低浓度,可以作为院内制剂养胃膏的鉴别方法。

OBJECTIVE Established the thin layer Chromatography(TLC)identification,relative density and moisture limit of hospital preparation YangWei oral paste.Discuss for quality control methods of YangWei oral paste.METHODS Set up the relative density,moisture limit and the TLC qualitative identification method of main components in YangWei oral paste,according to general rule in ChP 2020Ⅳ.RESULTS The TLC identification methods which established had a good reproducibility and specificity.The limit of quantitation of astragalosideⅣwas 0.1 mg·mL^(-1),and the limit of quantitation of tansinoneⅡA was 0.2 mg·mL^(-1).The established internal control standards such as relative density and moisture could reflect the quality of YangWei oral paste.CONCLUSION The TLC identification method established of YangWei oral paste is simple and reliable.The labeled components in the test solution is clearly and reach the minimum concentration of the quantification limit.It can be the identification method of hospital preparation YangWei oral paste.