Relative bioavalability of hydrochloride eperisone granule in healthy volunteers / 中国临床药理学与治疗学

Aim The relative bioavalability of hydrochloride eperisone granule in 10 healthy volunteers was studied. Methods The time-plasma concentrations of hydrochloride eperisone granule, as test drug, and myonal, as reference drug, were determined by GC-MS, with tolperisone senuing as internal standard.The pharmacokinetic parameters of both reference and test drug were calculated and analyzed with two-one side test and confidential interval test. Results The results showed that the AUC0-8, AUC0-∞, Cmax, Tpeak, t1/2(?) and t1/2(?) were (17.9?1.3)ng?h?ml-1 and(18.6?1.6)ng?h?ml-1, (19.1?1.2)ng?h?ml-1 and (20.2?1.6)ng?h?ml-1, (5.2?0.5)ng?ml-1 and (5.4?0.5) ng?ml-1, (1.05?0.18)h and (1.08?0.23)h, (0.78? 0.13)h and ( 0.82?0.14)h,( 1.8?0.3)h and (1.8?0.3)h, respectively. The relative bioavalability of test drug was (105? 5)%. Conclusion It can be concluded that the test and reference are bioequivalented between individuals, preparations and periods.

The Clinical Evaluation Of Eperisone Hydrochloride (Mulex) / 대한류마티스학회지

Conservative treatment is the main therapy for cervicobrachial syndrome, scapulohumeral periarthritis, and lumbago as diseases with both pain and myotonia. The-conservative treatment mainly consists of medication, physiotherapy, and kinesiotherapy. In the recent years, attempts have been made to give relief to myotonia through combination therapy with antiinflammatory analgesics and muscle relaxants. The muscle relaxants using in general are tolperisone hydrochloride, chlormezanone, and diazepam. Eperizone hydrochloride(Mulex tablet) is a beta-propriophenone derivatives and a central acting muscle relaxant, And it benefited subjective symptoms such as muscular pain (lumbago, neck pain) and a stiff muscle sensation (shoulder tension, tension feeling of lower limb). Among 22 patients, there were 14 lumbagos, two cephalobrachial syndromes, one scapulohumeral periarthritis, and five combined patients were chosen and duration of symptom was 5 years (3months-15years) in average. Mulex tablet was administered in a dose of 3 tablets (150rag) per day in 22 patients for 6 weeks prospectively. We analysed general improvement rating (GIR), general usefulness rating(GUR), and overall safety rating. The general improvement rate was 78% and the aggravation rate was 4%. The complication after, madication was infrequently gastrointestinal trouble. Incidence of side effect was 22%, but all these complications were insignificant. Hematology, blood chemistry, and urinalysis after medication were normal.