银杏叶提取物及其制剂质量监督专项工作中的风险控制

目的：介绍银杏叶提取物及其制剂质量监督的专项治理行动中成功运用的风险控制体系，以推进在全系统中的应用。方法：采用高效液相色谱法，使用C₁₈（4.6 mm×250 mm，5 μm）色谱柱，以乙腈（A）-0.4%磷酸溶液（B）为流动相，梯度洗脱，建立了银杏叶提取物及其制剂的指纹图谱；并就风险控制体系的几个方面进行介绍，包括风险分析、风险交流及风险管理等在银杏叶提取物专项治理工作中的作用的详细论述。结果：通过比较银杏叶提取物及其制剂指纹图谱的异同，发现银杏叶药品存在的系统性风险，通过风险分析，发现补充检验方法可能存在的风险点并对风险进行控制。风险管理和风险交流贯穿于银杏叶药品专项治理工作的始终。结论：银杏叶提取物及其制剂质量监督专项工作中成功运用了风险控制，通过风险分析、风险管理及风险交流，使得银杏叶药品专项治理工作得以完成。

Objective: The risk control system in the special supervision on the extract of Ginkgo biloba and its preparations was introduced to be applied in drug administration.Methods: The fingerprints of Ginkgo biloba extract and its preparations were established by HPLC method and the C₁₈ column(250 mm×4.6 mm,5 μm)was adopted.The mobile phase consisted of acetonitrile(A)and 0.4% phosphoric acid(B)with a gradient elution.Several aspects of risk control system, including risk analysis, risk communication and risk management were discussed in detail.Results: The systemic risk in Ginkgo biloba drugs was found by comparing the differences between the fingerprints of Ginkgo biloba extract and its preparation. Through the risk analysis,the possible risk was revealed and controlled. Risk management and risk communication ran throughout the special supervision on Ginkgo biloba preparations. Conclusion: The risk control system, including risk analysis, risk communication and risk management,was successfully applied in the special supervision on Ginkgo biloba extract, which has played a leading role in the whole system.

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