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目的:建立温阳平喘胶囊的质量标准。方法:采用TLC法对处方中的麻黄、黄芩进行了定性鉴别;对附片进行了乌头碱的限量检查;用高效液相色谱法测定黄芩苷的含量。结果:黄芩苷在1.712～42.80μg范围内呈现良好的线性关系。回归方程为Y=293.7X-216,r=0.9999,理论板数在2000以上;定性鉴别TLC色谱中有麻黄及黄芩的特征斑点;乌头碱限量不超过规定。结论:所建立的方法准确可靠,重现性好,可用于该制剂的质量控制。
Objective: To establish the quality standard of Wenyang Pingchuan Capsule. Methods: The qualitative identification of ephedra and astragalus in the prescriptions was carried out by TLC method. The aconitine limit test was performed on the tabs; the content of baicalin was determined by high performance liquid chromatography. Results: Baicalin exhibited a good linear relationship in the range of 1.712 to 42.80 μg. The regression equation is Y=293.7X-216, r=0.9999, the number of theoretical plates is above 2,000; the characteristic spots of ephedra and jaundice are found in qualitative identification TLC chromatograms; the limit of aconitine is not more than specified. Conclusion: The established method is accurate and reliable with good reproducibility and can be used for quality control of the preparation.