Studies Of Quality Standard And Pharmacodynamics On Mongolian Medicine Yuzanqingyan-15Pills

Objective:To establish the quality standard for Mongolian Medicine Yuzanqingyan-15pills and to study its pharmacodynamics.Methods:Microscopic identification was used for the identification of medicinal materials in the prescription. The modern technology of TLC was used for the identification of Garden, Radix Aucklandiae and glacyrrhiza in the prescription. According to the pharmacopoeia, the method of ethyl amide and Gutzeit were used to determine the heavy metals content and arsenic salts and toluene method was used to determine the water content; content weight difference in preparations and the time limit of disintegration were detected with the lowest amount inspection and disintegration time limit method.HPLC was used to measure the content of Gardenoside.HPLC conditions were as follows: VP-ODS column (Diamonsil C185μm4.6mm×250mm), a mobile phase of CH3CN-H2O(15:85), detection wavelength238nm, flow velocity1.0ml/min, column temperature30℃, theoretical plate number not lower than1500Gardenoside peaks.Dimethylbenzene-induced auricle tumefaction test of mice, carrageenin-induced foot swelling test of rats, hot plate test of mice, acetic acid-induced writhing test of mice were used to study the anti-inflammatory and analgesic effects of Yuzanqingyan-15pills.Results:1. With microscopic identification methods, the microscopic characteristics of medicinal materials in Yuzanqingyan-15were researched.2. Garden, Radix Aucklandiae and glacyrrhiza were found in the prescription by TLC. No interference in the corresponding position in negative control was detected. Low temperature,low humidity and high humidity have no obvious effect on the separation. Qualitative analysis method was precise, reliable and simple.,3. Five batches of products checked are in line with regulations on heavy metals content.4. Gardenoside was linear within the range of0.128-0.765μg with a correlation coefficient of0.9996. The average recovery percentage was99.33%and RSD was1.20%(n=6).5. The results of pharmacodynamics experiment show:compared with blank group, in auricle tumefaction test of mice, the tumefaction of high dose group relieved obviously(P<0.05); in carrageenin-induced foot swelling test of rats, the tumefaction of both high dose group and low dose group were improved obviously (P<0.05, P<0.01); in hot plate test of mice, the pain threshold of both high dose group and low dose group were increased(P<0.05); in acetic acid-induced writhing test of mice, the writhing times of high dose group decreased significantly(P<0.05).Conclution:1. The quality standard for Mongolian Medicine Yuzanqingyan-15pills was established. The method is evidenced to be simple, timesaving and accurate with a favorable reliability; therefore it can be used effectively for the quality control of Yuzhanqingyan-15pills.2. Mongolian Medicine Yuzanqingyan-15pills show significant analgesic and anti-inflammatory pharmacological effects.