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对痰热清注射液固形物中焦谷氨酸(P-Glu)的组分含量进行分析,通过对比P-Glu标准物质,采用反相高效液相色谱法(RP-HPLC)对不同批次的痰热清注射液的固形物进行测定,确定不同批次痰热清注射液中P-Glu含量。研究中所用色谱柱为Sionchrom ODS-BP(200 mm×4.6 mm,5μm),流动相为乙腈和3.5 mmol/L磷酸二氢钠缓冲液(两者体积比为1∶99),流速为1.0 mL/min,检测波长205 nm,柱温27℃。结果发现,不同批次痰热清注射液中P-Glu含量范围为0.5%～1.2%,平均含量近0.86%,故不同批次药品中P-Glu含量有一定差异。该方法能快速、有效地分析测定痰热清注射液固形物中P-Glu含量,对该注射液的质量控制有着重要意义。
The contents of pyroglutamic acid (P-Glu) in Tanreqing Injection were analyzed. By comparing RP-HPLC with P-Glu standard, Of Tanreqing injection solid content was determined to determine the different batches of Tanreqing P-Glu content of injection. The column used in this study was Sionchrom ODS-BP (200 mm × 4.6 mm, 5 μm) with a mobile phase of acetonitrile and 3.5 mmol / L sodium dihydrogen phosphate buffer (volume ratio of 1:99) at a flow rate of 1.0 mL / min, detection wavelength 205 nm, column temperature 27 ℃. The results showed that P-Glu content in different batches of Tanreqing injection ranged from 0.5% to 1.2% with an average content of nearly 0.86%. Therefore, the content of P-Glu in different batches of drugs was different. The method can rapidly and effectively analyze and determine the content of P-Glu in the solid of Tanreqing Injection and is of great significance for the quality control of the injection.