消痔片质量标准研究

Study on quality standard for Xiaozhi Tablets

目的 :建立了消痔片的质量标准 (马勃、薯莨、山豆根、牡砺等 )。方法 :采用TLC法对处方中薯莨、山豆根进行鉴别 ;用HPLC法测定苦参碱含量。结果 :在TLC色谱中均能检出薯莨、山豆根 ;苦参碱在 0 .2 0 4～ 2 .0 4 0 μg范围内呈良好线性关系 (r=0 .9999) ,平均回收率为 97.6 4 % ,RSD为 1.4 9%。结论 :本方法简便可行 ,重现性好 ,为消痔片的质量控制提供了方法。

AIM: To establish the quality standard for Xaozhi Tablets(Lasiosphaera seu Calvatia, Rhizoma Dioscoreae Cirrhosae, Radix Sophorae Tonkinensis, Concha Ostreae, etc.). METHODS: Rhizoma Dioscoreae Cirrhosae and Radix Sophorae Tonkinensis were identified by TLC. Matrine was determined by HPLC. RESULTS: Rhizoma Dioscoreae Cirrhosae and Radix Sophorae Tonkinensis could be detected by TLC. Matrine showed a good linear relationship in the range of 0.2040～2.040μg and the average recovery was 97.64%, RSD was 1.49%. CONCLUSION: The methods are simple, sensitive and accurate with good reproducibility. The methods may be used for the quality control of Xiaozhi Tablets.