提高小儿盐酸赖氨酸颗粒质量标准的研究
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摘要
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 C18 column(250 mm×4.6 mm,5μm)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.
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 C18 column(250 mm×4.6 mm,5μm)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.
引文
[1]刘玉波,苗惠珠,刘艳娥,等.复方赖氨酸颗粒中盐酸赖氨酸的HPLC测定[J].药物分析杂志,1999,19(6):410-412.
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[13]王棘,潘雪妍,杨宏伟.HPLC法和氨基酸分析仪(AAA)法测定肠外营养注射液(25)中18种氨基酸的含量的比较[J].药物分析杂志,2012,32(6):1085-1089.
[14]Arrieta M P,Prats-moya M S.Free amino acids and biogenic amines in Alicante Monastrell wines[J].Food Chem,2012,135(3):1511-1519.
[15]张萍,周玉春,王晓,等.HPLC柱前衍生化法测定发酵虫草制剂中总氨基酸的含量[J].药物分析杂志,2016,36(8):1338-1348.
[16]LU Yongmei,LU Xin,CHEN Xiaohong,et al.A survey of biogenic amines in Chinese rice wines[J].Food Chem,2007,100(4):1424-1428.
[17]冯欢,李新霞,冯崴,等.柱前衍生化HPLC法测定不同产地胡芦巴中4-羟基异亮氨酸的含量[J],西北药学杂志,2016,31(2):136-138.
[18]张亿,朱蓉,郑萍,等.邻苯二甲醛柱前衍生化HPLC法测定复方制剂中盐酸赖氨酸的含量[J].中国药房,2015,26(15):2131-2133.
[19]Onal A,Tekkei S E K,Onal C.A review of the liquid chromatographic methods for the determination of biogenic amines in foods[J].Food Chem,2012,138(1):509-515.
[20]Busto O,Valero Y,Guasch J,et al.Solid phase extraction applied to the determination of biogenic amines in wines by HPLC[J].Chromatographia,1994,38(9/10):571-578.
[2]姜静岩,刘顺良,尹晓飞.注射用盐酸赖氨酸辅助治疗急性颅脑损伤的临床疗效[J].解放军药学学报,2007,23(3):237-238.
[3] WS-10001-(HD-0793)-2002,国家药品标准:化学药品地方标准上升国家标准:第九册[S].
[4]赵庄.对《中国药典》(2000年版)盐酸赖氨酸含量测定方法的改进[J].中国药事,2002,16(6):352.
[5]程晓梅,尚伟,王娜.可见分光光度法测定盐酸赖氨酸含量[J].长春中医学院学报,2003,19(2):37.
[6]张伟,卓芝,周定娟,等.高效液相色谱-蒸发光散射检测法测定复方盐酸赖氨酸片的含量[J].儿科药学杂志,2004,10(4):43-44.
[7]张莉,黄哲苏,李海生.异硫氰酸苯酯柱前衍生法测定门冬氨酸鸟氨酸注射液含量[J].药物分析杂志,2008,28(7):1174-1176.
[8]张莹,黄哲甦.异硫氰酸苯酯柱前衍生法测定复方氨基酸注射液(3AA)中氨基酸含量[J].天津药学,2013,25(4):17-20.
[9]芮鸿飞,张晓瑜,刘兴泉,等.PITC柱前衍生-反相高效液相色谱法测定黄酒中游离氨基酸和生物胺[J].食品科学,2016,37(8):159-161.
[10]杨菁,孙黎光,白秀珍,等.异硫氰酸苯酯柱前衍生化反相高效液相色谱法同时测定18种氨基酸[J].色谱,2002,20(4):369-371.
[11]孔彬,巴吐尔·买买提明,马晓丽,等.柱前衍生RPHPLC荧光检测法测定人血浆中17种氨基酸[J].西北药学杂志,2013,28(2):141-144.
[12]陈再洁,殷金龙,李坤,等.柱前衍生RP-HPLC法测定人参中17种氨基酸的含量[J].中国药房,2012,23(25):3334-3337.
[13]王棘,潘雪妍,杨宏伟.HPLC法和氨基酸分析仪(AAA)法测定肠外营养注射液(25)中18种氨基酸的含量的比较[J].药物分析杂志,2012,32(6):1085-1089.
[14]Arrieta M P,Prats-moya M S.Free amino acids and biogenic amines in Alicante Monastrell wines[J].Food Chem,2012,135(3):1511-1519.
[15]张萍,周玉春,王晓,等.HPLC柱前衍生化法测定发酵虫草制剂中总氨基酸的含量[J].药物分析杂志,2016,36(8):1338-1348.
[16]LU Yongmei,LU Xin,CHEN Xiaohong,et al.A survey of biogenic amines in Chinese rice wines[J].Food Chem,2007,100(4):1424-1428.
[17]冯欢,李新霞,冯崴,等.柱前衍生化HPLC法测定不同产地胡芦巴中4-羟基异亮氨酸的含量[J],西北药学杂志,2016,31(2):136-138.
[18]张亿,朱蓉,郑萍,等.邻苯二甲醛柱前衍生化HPLC法测定复方制剂中盐酸赖氨酸的含量[J].中国药房,2015,26(15):2131-2133.
[19]Onal A,Tekkei S E K,Onal C.A review of the liquid chromatographic methods for the determination of biogenic amines in foods[J].Food Chem,2012,138(1):509-515.
[20]Busto O,Valero Y,Guasch J,et al.Solid phase extraction applied to the determination of biogenic amines in wines by HPLC[J].Chromatographia,1994,38(9/10):571-578.