肛肠袋泡剂质量标准研究

Study on Quality Standard of Anorectal Granules in Bag

目的建立肛肠袋泡剂的质量控制标准。方法采用高效液相色谱（HPLC）法测定了处方中主药黄柏内盐酸小檗碱的含量。结果盐酸小檗碱进样质量浓度在30.0-150.0μg/mL范围内与峰面积线性关系良好（r=0.999 6）,平均回收率为97.40%,RSD为1.27%（n=6）。结论该方法可有效控制肛肠袋泡剂的质量。

Objective To establish the quality control standard of this new traditional Chinese medicine Anorectal Granules in Bag.Methods The HPLC method was adopted for determining the main drug berberine hydrochloride content in the formula. Results The mass concentration for the berberine hydrochloride sample size in the range of 30. 0- 150. 0 μg / mL showed the good linearity（ r =0. 999 6）. The average recovery rate of berberine hydrochloride was 97. 40% with RSD = 1. 27%（ n = 6）. Conclusion This quality standard can effectively control the quality of this preparation.