复方消积止咳蜜炼膏的质量标准及初步稳定性考察

目的建立复方消积止咳蜜炼膏的质量标准,并对其初步稳定性进行研究。方法采用薄层色谱（TLC）法对方中陈皮、五味子、山楂进行定性鉴别;采用高效液相色谱法（HPLC）对制剂中细叶远志皂苷进行含量测定。结果复方消积止咳蜜炼膏中陈皮、五味子、山楂薄层色谱斑点清晰、分离度好、专属性强;细叶远志皂苷在进样浓度0.02～0.20 mg/mL范围内与峰面积积分值呈良好线性关系,线性方程为Y=4.057×10^3X-6.008×10^4（r=0.999）。平均回收率为100.24%,RSD=2.04%（n=9）。初步稳定性试验表明制剂质量稳定。结论本方法简便易行,适合用于复方消积止咳蜜炼膏的质量控制。

Quality standard of Fufang Xiaoji Zhike Milian Concentrated Decoction and preliminary study on its stability

Objective To establish the quality standard of Fufang Xiaoji Zhike Milian Concentrated Decoction and to investigate its preliminary stability so as to determ its validity duration. Methods TLC method was applied to the identification of Pericarpium Cirri Reticulatae, Fructus Sehisandrae Chinensis and Fructus Crataegi; HPLC method was adopted to determine the contents of Tenuifolin. Results The TLC spots of Pericarpium Citri Reticulatae, Fructus Schisandrae Chinensis and Fructus Crataegi were clear, well-separated and spectific. The linear range of Tenuifolin was 0.02-0.20 mg/mL （r=0.999）, with the regression equation was Y=4.057×10^3X-6.008×10^4（r=0.999）. The average recovery was 100.24 % with RSD of 2.04% （n = 9）. The quality of Fufang Xiaoji Zhike Milian Concentrated Decoction was stable in stability test. Conclusion The established method is simple and feasible, and it can be used to the quality control Fufang Xiaoji Zhike Milian Concentrated Decoction.