Method for determining residual amount of methanol in recombinant hand-foot-and-mouth disease vaccine stock solution and application of method in preparation of recombinant hand-foot-and-mouth disease vaccine

The embodiment of the invention discloses a method for determining the residual amount of methanol in a recombinant hand-foot-and-mouth disease vaccine stock solution and application of the method inpreparation of a recombinant hand-foot-and-mouth disease vaccine. The determination method comprises the following steps: preparing a sample solution; enabling the sample solution to enter a gas chromatograph through a headspace sample injector, and measuring the content of methanol in the sample solution. With application of the method, the residual amount of methanol in the recombinant hand-foot-and-mouth disease vaccine stock solution can be accurately determined, a basis is provided for the safety of the recombinant hand-foot-and-mouth disease vaccine, and real, reliable and effective datais provided for the stability of the process. 本发明实施例公开了一种重组手足口病疫苗原液中甲醇残留量测定方法及其在制备重组手足口病疫苗中的应用。所述测定方法包括以下步骤：制备样品溶液；样品溶液通过顶空进样器进入气相色谱仪，测定样品溶液中的甲醇含量。实施本发明，可对重组手足口病疫苗原液的甲醇残留量进行准确测定，为重组手足口病疫苗安全性提供依据，为工艺的稳定性提供真实、可靠、有效的数据。