The Pharmaceutical Study Of Levodopa And Benserazide Hydrochloride HBS Capsules

This paper discussed the manufacture of Levodopa and Benserazide Hydrochloride Hydrodynamically Balanced System Capsules using HPMC as hydro- gel matrix material, hydrogenated vegetable oil as fatty materials.It can remain floating in gastric fluid for a long time and controll release compositions. High-performance liquid chromatography was developed for the determination content and release in vitro assay.Levodopa and Benserazide Hydrochloride HBS Capsules is a compound preparation,which contains levodopa and benserazide (4:1). This medicine is used to treat parkinson disease. Levodopa and Benserazide Hydrochloride HBS Capsules is more effective and has less adverse reaction than other medicine. Levodopa and Benserazide Hydrochloride HBS Capsules has not been manufactured and sold in China. This project will improve economic performance and social effect.During the prescription and technical study, first we had done some research on the interaction of drug and excipients to screen out suitable excipients, and the resule showed the capsules should be stored in condition of cool and dry packing with blister pack. Levodopa and benserazide hydrochloride wet granulation respectively. We studies the single factor influencing drug release such as content of hydro gel matrix material, then we optimized the prescription with irthogonal design based on the mono-factor experiment. The optimized prescription is as follows: levodopa granules contain: levodopa 100mg; hydrogenated vegetable oil, 10mg; HPMC K4M, 40mg; mannitol 30mg; benserazide hydrochloride granules contain : benserazide hydrochloride 28.5mg(equivalent to 25mg benserazide); hydrogenated vegetable oil, 20mg; HPMC(K4M: K15M= 1:1), 30mg; calcium phosphate dibasic, 10mg; magnesium stearate 2.5mg; weight 271mg. The dissolution profiles of levodopa and benserazide hydrochloride conform to Higuchi and Ritger-Peppas model. The release of levodopa is synergistic effect of diffusion and bulk erosion, benserazide hydrochloride conforms to Fick diffusion.We studied the quality of Levodopa and Benserazide Hydrochloride HBS Capsules, including identification, related substance, assay and release, and we determined the content of levodopa and benserazide hydrochloride by HPLC and the analytical methods validationWe did the stability test of Levodopa and Benserazide Hydrochloride HBS Capsules, including accelerated test and long-term test. And the study showed the Levodopa and Benserazide Hydrochloride HBS Capsules is very stable.