The Quality Control Of The Malaridine Phosphate Capsule

Malaria is a kind of infectious parasitic diseases caused by the spreading of plasmodium parasite on human body through mosquitoes. Malaridine phosphate is a kind of antimalarial drug, which can combine with hemoglobin through competition to restrain the growth and proliferation of the plasmodium. In this article, we studied prescription and quality standard of malaridine phosphate capsule, provided gist for the research of the new drug.According to the physicochemical property and feature of the original auxiliary materials, we designed eight prescriptions with the malaridine phosphate capsule.Through the shape, the appearance, the angle of repose, the dissolution and the evaluation of particle, malaridine phosphate capsules was evaluated as hard capsule.Its specification is 0.1g, the labeled amount of every malaridine phosphate particle(calculated with malaridine) is 90.0% ~ 110.0%, the color of its content is from yellow to aurantium. The suitable formulation of prescription(1000 grains malaridine phosphate capsules) :100 g malaridine phosphate(calculated with malaridine), 88 g starch, 7g sucrose, 80 g 10% starch slurry, 0.01 g magnesium stearate. The prescription is reasonable, simple and feasible.Malaridine phosphate capsule is stable in high temperature(60 ?) and hard light(4500 lx±500 lx), but it is sensitive in high humidity(75%±5%). Through the accelerated test and the stability test, the appearance, difference of filling quantity limit, dissolution, moisture, microbial limit, content and related substances is of no obvious changes within 24 months. The storage conditions is keeping in dark place and sealed preservation. Its validity is two years. Through this test, we solved the disadvantage of low bioavailability and less dosing way in the existing preparation,which had a fine market effect and created good economic benefit and social benefit for the manufacturing enterprises.