提高小儿盐酸赖氨酸颗粒质量标准的研究

Study on the improvement of the quality standard of Pediatric Lysine Hydrochloride Granules

目的研究小儿盐酸赖氨酸颗粒的质量标准。方法根据盐酸赖氨酸的化学结构及性质,对其制剂进行定性鉴别。采用HPLC法测定,以异硫氰酸苯酯为衍生试剂,采用C18色谱柱(250mm×4.6mm,5μm),以0.1mol·L^(-1)醋酸钠溶液(用稀醋酸调节pH值至6.4)为流动相A,乙腈为流动相B,水为流动相C,进行梯度洗脱;检测波长为254nm;用内标法测定盐酸赖氨酸的含量。结果拟定了小儿盐酸赖氨酸颗粒的质量标准。结论拟定的质量标准可用于小儿盐酸赖氨酸颗粒的质量控制,并采用HPLC法代替非水滴定法测定主药的含量,有效分离盐酸赖氨酸与其他氨基酸,该方法专属性强、准确可靠。

Objective To study the quality standard of Pediatric Lysine Hydrochloride Granules. Methods Qualitative identification was carried out based on the chemical configuration and property of lysine hydrochloride in the granules.An HPLC method was established with pre-column derivatization for determining the content of lysine hydrochloride,in which phenyl isothiocyanate （PITC） was used as a derivative reagent.The C 18 column （250 mm×4.6 mm,5 μm） was used.The mobile phase A was 0.1 mol ·L -1 sodium acetate buffer （adjusting pH to 6.4 with acetic acid）,the mobile phase B was acetonitrile and mobile phase C was water with gradient elution.The detection wavelength was 254 nm.Internal standard method was adopted for the determination of lysine hydrochloride. Results The quality standard of Lysine Hydrochloride Granules was established. Conclusion The quality standard can be used for the quality control of Lysine Hydrochloride Granules.The method can effectively separate lysine hydrochloride and other amino acids,which is accurate and reliable.