痛块消口服液的质量标准研究
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篇名: 痛块消口服液的质量标准研究
TITLE:
摘要: 目的:建立痛块消口服液的质量标准。方法:采用薄层色谱法(TLC)对制剂中夏枯草、拳参进行定性鉴别;采用高效液相色谱法测定制剂中吗啡的含量:色谱柱为Kromsail C18,流动相为乙腈-0.1%磷酸溶液(15 ∶ 85,V/V)(每100 mL加庚烷磺酸钠0.1 g),流速为1.0 mL/min,检测波长为220 nm,柱温为25 ℃,进样量为10 μL。结果:夏枯草、拳参的TLC图斑点清晰,分离度好,阴性对照无干扰。吗啡检测质量浓度线性范围为15.13~242.08 μg/mL(r=0.999 9);精密度、重复性、稳定性试验的RSD<2.0%;加样回收率为97.80%~102.10%(RSD=1.57%,n=6)。结论:该研究所建标准可用于痛块消口服液的质量控制。
ABSTRACT: OBJECTIVE: To establish the quality standard for Tongkuaixiao oral liquid. METHODS: TLC was used for the qualitative identification of Prunella vulgaris and Polygonum bistorta in the preparation; HPLC was used for the content determination of morphine: the column was Kromsail C18 with mobile phase of acetonitrile-0.1% phosphoric acid (15 ∶ 85,V/V) (each 100 mL added sodium heptanesulfonate 0.1 g) at a flow rate of 1.0 mL/min, detection wavelength was 220 nm, column temperature was 25 ℃, and injection volume was 10 μL. RESULTS: The TLC spots of P. vulgaris and P. bistorta were clear and well-separated, negative control without interference. The linear range of morphine was 15.13-242.08 μg/mL(r=0.999 9); RSDs of precision, stability and reproducibility tests were lower than 2.0%; recovery was 97.80%-102.10% (RSD=1.57%,n=6). CONCLUSIONS: The establish standard can be used for the quality control of Tongkuaixiao oral liquid.
期刊: 2017年第28卷第3期
作者: 梁莹莹,张淑君,赫军,张丹,刘晓,王晓星,马秉智
AUTHORS: LIANG Yingying,ZHANG Shujun,HE Jun,ZHANG Dan,LIU Xiao,WANG Xiaoxing,MA Bingzhi
关键字: 痛块消口服液;薄层色谱法;高效液相色谱法;质量标准;吗啡
KEYWORDS: Tongkuaixiao oral liquid; TLC; HPLC; Quality standard; Morphine
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