| The preparation process,quality criteria,efficacy and safety evaluation of each stage in the Liujing headache table production were studied in this dissertation.Orthogonal design test was applied to optimize the granulating process of the Liujing headache table.Ultimately,the parameters of boiling granulating process were confirmed,including the speed of peristaltic pump 40 ~ 60 rad/min,atomizing pressure 1.1 ~ 1.5 MPa,material temperature 80 ~ 85 ℃ and using pure water.After three consecutive bathes of enlarge production and stability test,the appearance,disintegration time,tablet weight variation,microbial limits of the end products were all in line with the evaluation requirements.The results showed the good quality evaluation criteria and stable process parameters,which were suitable for mass production.The identification method of Angelica dahurica,Magnolia FLos,Chuanxiong and Gaoben by TLC was developed for the Liujing headache table.Aristolochic acidⅠ should not be detected by HPLC.The content limit of Puerarin is3.0mg/tablets determined by HPLC.The chromatographic conditions were C18 column,methanol and sodium dihydrogen phosphate(adjusted to pH 2.5 to 3 with phosphoric acid)(20:80)as mobile phase,column temperature 35 ℃,flow rate 1.0ml/min,detection wavelength 250 nm,theoretical plates number according to the Puerarin peak no less than 6000.Through the experiment exploration and method durability tests proved that such method was a exclusive and feasible quality standard detection method for six-channel headache table.With Chuanxiong chatiao tablets as the control drug,Evaluate efficacy and safety of the Liujing headache tables,with treatment of upper respiratory tract infection,tension-type headache,migraine headache(exogenous pathogenic wind syndrome)positive randomized double blind and double simulation,parallel-group,multicenter clinical trial.The curative effect of the Liujing headache table for the treatment of upper respiratory tract infection,headache and migraine(exopathic wind syndrome)was reliable.Also,the effect in dispelling wind and activating effect,analgesic benefit of body was exact.Liujing headache table had no adverse drug reaction,safety and non-toxic side effects.Liujing headache table is worthy of furtherpromotion in treatment the of upper respiratory tract infection,headache,migraine and tension headaches. |
