The Quality Control of the Malaridine Phosphate Capsule
作者: 王洪杰 ：格特生物制药(天津)有限公司，天津;
Abstract: Malaria is an infectious disease which is spread by mosquitoes biting. Its features are shiver, high fever, sweating defervescence, anemia and splenomegalia. Malaria remains one of the ten largest infectious diseases globally. According to statistics, 300 - 500 million people are infected by malaria and 1 million people are died of malaria annually. The new anti-malarial medicine synthesized at the beginning of 1970s exists in the form of tetraphosphate clinically. This paper is to determine the prescription and production process of new drug—Malaridine Phosphate Capsule, establish quality standards, perform pilot scale production and detection, carry out acceleration and long-term stability investigation and research pharmacology, toxicology, pharmaceutical effect, pharmacokinetics, etc. It is to determine the optimum prescription and process by orthogonal test, hydromechanics, angle of repose research and pharmaceutical technology. It is to build quali-ty-control method by HPLC and UV; to perform pilot large-scale production and detection in national GMP workshop, detect the appearance, related substances, dissolution rate and content of commercially available packages by sampling in 40˚C, 40% relative humidity and 25% ± 5%, 60% ± 5% relative humidity respectively according to new drug stability guiding principle. Conclusion: 1) Reasonable prescription. 2) Simple and feasible process. 3) Quality standards and detection method have been established. 4) 2-year of stable-quality expiry date. 5) Obvious economical and social benefits instead of inadequate conventional formulations and bioavailability.
文章引用: 王洪杰 (2015) 磷酸咯萘啶胶囊的质量研究。 药物资讯， 4， 1-14. doi: 10.12677/PI.2015.41001
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