Objective:To improve the quality standard of the traditional Mongolian patent medicine Sugmul-10 pills by the establishing of microscopic

TLC

physiochemical identification

and HPLC content assay methods. Method: Alpiniae oxyphyllae fructus

Caesalpinia fructus

Malva fructus and Eriocheir sinensis were identifred by microscopical analysis of episperm sclerenchymatous cells

scleroticnests and body wall debris in the sample powder. TLC identification of Alpiniae oxyphyllae fructus was performed on a silica gel plate GF254

with cyclohexane-ethyl acetate (9∶1) as developing solvent and standard medicinal materials as controls. Physiochemical methods were used to identify ammonium chloride in Sal Ammoniacus and calcium carbonate in Eriocheir sinensis. Piperine from Piperis longi fructus was selected for content supervision. HPLC method was performed on a ODS column

eluted with methol-H2O (77∶23)

and detected at 343 nm. Result: Five medicinal materials from Sugmul-10 pills can be identified by the methods

including Alpiniae oxyphyllae fructus

Caesalpinia fructus

Malva fructus

Sal Ammoniacus and Eriocheir sinensis. HPLC content determination method showed good linearity(r=0.999 9) in the range of 0.040 4-0.282 8 μg. The average recovery rate of piperine was 98.1% with RSD 0.62%

and the content limitation is not less than 1.4 mg·g-1. Conclusion: This methods can effectively control the product quality.