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目的建立了“云威灵油软胶囊”溶出度的测定方法。方法以60%乙醇溶液100ml为溶出介质,采用小杯法(80r/min)40min取样,采用气相色谱法对其溶出度进行测定,并考察了溶出曲线。结果样品溶出均一性良好,溶出度均>70%。结论该方法结果可靠,可作为该产品质量控制的方法。
Objective To establish a method for measuring the dissolution of Yunwei Lingyou Soft Capsule. Methods The dissolution medium was prepared with 100% ethanol solution (100ml) and sampled by the small cup method (80r/min) for 40min. The dissolution was determined by gas chromatography and the dissolution profile was examined. Results The samples were well-dissolved and the dissolution was >70%. Conclusion The method is reliable and can be used as a method for quality control of the product.