萎胃宁颗粒剂的质量控制及稳定性考察

Establishment of the quality standard of Weiweining granules and investigation on its stability

目的：建立萎胃宁颗粒的质量标；住，并对其稳定性进行考察。方法：采用薄层色谱（TLC）法对方中延胡索、白术进行定性坚别；采用高效液相色谱法对制剂中野黄芩苷进行含量测定。结果：TLC宽点清晰、分离度好、专属性强；野黄芩苷进样浓度（0.016～0．16mg·mL^-1。范围内与峰面积积分值呈良好线性关系（r=0．999），平均回收率为99．13％，RSD为2．42％（7F9）。萎胃宁颗粒有效期暂定为2年。结论：本方法简便易行，适合用于萎胃宁颗粒的质量控制。

OBJECTIVE To establish the quality standard of Weiweining granules and to investigate its stability so as to determine its validity duration. METHODS TLC method was applied to the identification of tetrahydropalmatine and Atractylodes macrocephala; HPLC method was adopted to determine the contents of scutellarin. RESULTS TLC spots were clear,well-sepa rated and specific. The linear range of scutellarin was 0.016～0. 16 mg. mL^-1（r = 0. 999） with an average recovery of 99. I3 （RSD = 2. 42%, n = 9）. The validity duration of Weiweining granules was tentatively set as 2 years. CONCLUSION The established method is simple and feasible to operate,and it can be used to the quality control of Weiweining granules.