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目的:研制腰腿痛合剂并制定质量标准。方法:经多次煎煮浓缩加适量防腐剂,灭菌,制备腰腿痛合剂;对制剂中的氨基酸、糖类、苷类成分及独活进行定性鉴别,采用高效液相色谱法对制剂中的蛇床子素含量进行定量分析。结果:腰腿痛合剂味苦,呈棕褐色,性质稳定;蛇床子素在9.61～22.42μg·ml~(-1)的范围内线性关系良好(r=0.9995),平均回收率为98.97%,RSD为0.36%。结论:腰腿痛合剂质量可控。
OBJECTIVE: To develop a low back pain mixture and to establish quality standards. Methods: After decocting for several times, adding proper amount of preservative and sterilizing to prepare the remedial agent for waist and leg pain. The amino acids, saccharides and glycosides of the preparations were identified qualitatively and separately by using high performance liquid chromatography (HPLC) Osthol content quantitative analysis. Results: The results showed that waist and leg pain mixture had bitter, tan color and stable properties. Osthin had a good linearity (r = 0.9995) in the range of 9.61 ~ 22.42μg · ml ~ (-1) with an average recovery of 98.97% RSD is 0.36%. Conclusion: The quality of waist and leg pain mixture can be controlled.