张敏新，侯冠雄，黄爱文，宋洪涛*

(1.南京军区福州总医院药学科，福州 350025；2.福建中医药大学，福州 350122)



提高肠得安胶囊质量标准的研究

张敏新1，侯冠雄2，黄爱文1，宋洪涛1*

(1.南京军区福州总医院药学科，福州 350025；2.福建中医药大学，福州 350122)

目的 优化肠得安胶囊的质量标准。方法 对原标准中薄层色谱鉴别黄柏、大黄和厚朴3味药的鉴别项进行了优化，并增加了甘草、乌药和芍药的薄层鉴别；建立了HPLC法测定处方中黄柏的盐酸小檗碱含量，色谱柱：Agilent Zorbax XDB C18(150 mm×4.6 mm，5 μm);检测波长：345 nm。结果 各薄层色谱鉴别斑点清晰、分离好，阴性样品皆无干扰；含量测定盐酸小檗碱质量浓度在0.84～8.40 μg·mL-1范围内呈良好的线性关系 (r=0.999 9)；平均加样回收率为97.3%，RSD值为0.86% (n=9)。结论 所用定性、定量方法准确可靠，且能有效控制肠得安胶囊的质量。

盐酸小檗碱；肠得安胶囊；质量标准；薄层色谱法；高效液相色谱法

A.stract:Objective To optimize the quality standard of Changdean Capsules prescription. Methods The original standard TLC methods of cork，rhubarb,and magnolia were improved.The new TLC methods for licorice，herbs obtusiloba and peony were added.An HPLC method for the determination of citrus hesperidin was estabished. The analytical column was Agilent Zorbax XDB C18(150 mm×4.6 mm，5 μm)，and the UV detection wavelength was set at 345 nm. Results TLC spots were clear and well-separated without any interference. The linear range of berberine hydrochloride was 0.84-8.40 μg·mL-1.(r=0.999 9) with an average recovery of 97.3%，RSD was 0.86% (n=9). Conclusion The method is simple，specific，accurate and can effectively control the quality of Changdean Capsules.

慢性泄泻是一种常见病、多发病，从中医理论来说，系本虚标实证。本虚证常见脾肾两虚证，标实证常见湿热证，两者互为因果。本越虚则邪越实，邪越实则本越虚，以致病程缠绵，久治不愈，反复发作，给患者带来极大痛苦和不安。神州总医院高河元主任医师发现骨碎补为民间治疗泄泻的药物，经多年实践发现，单味骨碎补对标证为湿热的泄泻疗效不太理想，应健脾祛湿、理气止痛等全面兼顾，根据中医理论及临床实践，经过反复筛选，增加了黄柏、白芍等共18味药，其中9味药粉碎成细粉，另9味药水提并浓缩成浸膏与药粉共同制粒，干燥，装胶囊，即得。……