蒙药地梢瓜的质量标准研究

Study on the Quality Standards of Mongolian Medicine Cynanchum thesioides

目的:建立蒙药地梢瓜的质量标准。方法:采用薄层色谱法(TLC)鉴别地梢瓜药材;按2015年版《中国药典》(四部)方法检测药材中的水分、总灰分、醇溶性浸出物含量;采用高效液相色谱法(HPLC)测定药材中地梢瓜苷的含量。结果:TLC图斑点清晰,供试品(地梢瓜药材)与对照品(地梢瓜苷)在相应位置上均显示相同的黄绿色荧光斑点。22批地梢瓜药材的水分含量为6.18%~12.97%,总灰分含量为4.64%~7.95%,醇溶性浸出物含量为12.46%~32.70%。地梢瓜苷检测进样量的线性范围为0.048~3.050μg(R^2=0.9999);精密度、稳定性、重复性、耐用性试验的RSD均小于1%;加样回收率为104.03%~106.36%(RSD=0.96%,n=6);22批地梢瓜药材中地梢瓜苷的含量为0.0062%~0.1305%。结论:初步拟定地梢瓜中水分不得超过11.50%,总灰分不得超过7.50%,醇溶性浸出物不得少于17.00%,地梢瓜苷含量不得少于0.05%。所建质量标准可用于蒙药地梢瓜药材的质量控制。

OBJECTIVE:To establish the quality standards of Mongolian medicine Cynanchum thesioides.METHODS:TLC was used for the qualitative identification of C.thesioides.According to 2015 edition of Chinese Pharmacopeia(partⅣ),the moisture,total ash and ethanol-soluble extract were determined.HPLC method was used to determine the content of thesioideoside in C.thesioides.RESULTS:TLC spots were clear,there were same yellow green fluorescent spots on the corresponding position of the sample(C.thesioides)and control(thesioideoside).In 22 batches of samples,contents of moisture were 6.18%-12.97%,total ash were 4.64%-7.95%,ethanol-soluble extract were 12.46%-32.70%.The linear range of thesioideoside were 0.048-3.050μg(R^2=0.9999).RSDs of precision,stability,repeatability and durability tests were all less than 1%.The recoveries were 104.03%-106.36%(RSD=0.96%,n=6).The contents of thesioideoside in 22 batches of C.thesioides were 0.0062%-0.1305%.CONCLUSIONS:It is suggested that the moisture and total ash should not exceed 11.50%and 7.50%,respectively;the contents of ethanol-soluble extract and the sioideoside are no less than 17.00%and 0.05%,respectively.The established quality standards can be used for quality control of Mongolian medicine C.thesioides.