Nepalese Miscellaneous Research For Small Tablets And Capsules

Nizatidine is a new H₂-receptor-antagonist. It shows a competitive and preferential inhibitory effect on the combining of histamine and H₂-receptor. By preventing gastric cell from secreting hydrochloric acid, nizatidine can cure gastric or duodenum ulcer with good curative effect, light side effect and lower price. Otherwise,nizatidine is used for cure urticaria,herpes etc. As we know from literature, when once take nizatidine capsule 150 mg orally, T_max is 2 h, C_max is 1197ng/ml, T_1/2 is 1.6h. In this paper, nizatidine tablets and capsules were overall syudied on formulation design, optimization of preparation, establishment of quality control criteria and stability investigation.First, using the method of single factor investigation, the formulation and preparation of nizatidine tablets and capsules were optimized and decided considering synthetically several evaluation quotas.According to 2000 edition of Chinese Pharmacopoeia, the quality criteria of nizatidine tablets and capsules was studied on the basis of its physical and chemical property and the feature of tablets and capsules. The research included description, indetification, related substance, dissolution and content assay, etc. The examination method of related substance and content assay were improved on the HPLC method of USP 24.In new method, related substance and content were assay simultaneity and a lower concentration of buffer solution was used.The result of accelerated testing and room temperature testing showed that nizatidinetablets and capsules had good stability.