仔泻康口服液的质量标准研究

Study on the Quality Standard of Zai Oral liquid

关键词:  仔泻康口服液  博层鉴别  含量测定  质量控制

Key words:  Zai Oral liquid  TLC  HPLC  quality criteria

摘要:

为了制定仔泻康口服液质量标准,采用薄层色谱法(TLC)发对组方中黄芪、黄芩、黄连、白头翁进行定性鉴别；用高效液相色谱(HPLC)法对制剂中黄芩苷、盐酸小檗碱进行含量测定。结果TLC鉴别分离度好,简单,灵敏,专属性强。黄芩苷线性范围在0.12~0.75ug(R<sub>2</sub>=0.9975),平均回收率为97%,RSD=1.46%(n=6)；盐酸小檗碱线性范围在0.125~0.75ug(R<sub>2</sub>=0.9929),平均回收率为93.33%,RSD为2.21%(n=6)。对黄芪、黄芩、黄连的定性鉴别及黄芩苷、盐酸小檗碱的含量测定可为新药的研究提供试验资料。

Abstract:

To estable a quality control standaed for Zai oral liquid,Radix astragalos, Radix scutellariae,Rhizoma coptidis, Radix pulsatillae were identified by TLC .Content of Berberine hydrochloride and Baicalin were determinated by HPLC.The results showed that the TLC identification was good reproducibility,simple,sensitivity and highly specific.The calibration curve of Baicalin was linear in the range of 0.12 to 0.75ug(R<sub>2</sub>=0.9975).The average recovery rate was 97%,RSD=1.46%(n=6).The calibration curve of Berberine hydrochloride was linear in the range of 0.125 to 0.75ug(R<sub>2</sub>=0.9929).The average recovery rate was 93.33%,RSD=2.21%(n=6).The quality of the preparation could be controlled by qualitative identification of Radix astragalos, Radix scutellariae,Rhizoma coptidis, Radix pulsatillae and The result could be used for quality control of Zai Oral liquid tincture.