Inosine Sodium Chloride Injection Process And Quality Control

inosine (Inoside), also known as Inosine for the body's normal component involved in in vivo nucleic acid metabolism, energy metabolism and nucleic acid synthesis, activation of pyruvate oxidase to enhance the activity of coenzyme A, can in the low-energy oxygen state of the tissue cells to continue metabolism. Since the components can participate in energy metabolism and protein synthesis in vivo and activation of pyruvate oxidation enzymes, allowing cells to continue metabolism under hypoxia, prompting the damaged liver cells, heart cells and so the rapid repair, and therefore widely used in clinical practice, is mainly used for white blood cells and thrombocytopenia, a variety of acute and chronic hepatitis, heart disease, eye for central retinitis, optic nerve atrophy the main adjuvant therapy drugs in recent years, dermatologists for the treatment of psoriasis, flat wart, etc.; Prevention and the lifting of Dy agent poisoning and other poisoning caused by the heart and liver toxicity, for control of disease, improve the prognosis, there is a very important significance and clinical application. Inosine as a curative effect of the drugs, the tablets, injections after years of clinical use, in most areas are in sales, use of the drug, but so far there is no domestic manufacturers to produce and sell inosine sodium chloride injection, etc. injection products. Tablets role of the slow, low bioavailability, different manufacturers of inosine injection (small injection) in the process on a more or less, there are some instability in the light of this, we carried out the necessary Process and Control Research , according to their clinical usage for the 0.2-0.6g of glucose or sodium chloride into the intravenous drip, legislative questions developed Inosine Sodium Chloride Injection (100ml: 0.2g), to enhance the stability of the product improved drugs the timeliness of clinical efficacy, safety, can be widely applied to reduce the iatrogenic cross-infection, as much as possible to avoid, reduce side effects. As the injection has good efficacy, side effects and other features of its domestic market prospect is very impressive, development and production of inosine and sodium chloride injection is bound to produce good social and considerable economic benefits. New drug approval by the relevant provisions of inosine is a western four new drugs, clinical trials can be done to avoid a direct declaration of production.The study from the topics of the purpose and basis for the status quo at home and abroad about the food research or production, usage overview, inosine and sodium chloride injection overview of the research work, inosine and sodium chloride injection for the clinician's reference pharmacological, toxicological overview of inosine and sodium chloride injection preparation prescription and Technology, inosine and sodium chloride injection sources of raw materials and quality standards, quality standards for inosine and sodium chloride injection, and the drafting of the Bill shows that inosine chlorine Sodium Injection routine tests the quality of research data, a number of inosine and sodium chloride injection of biological testing, product stability study tours items and testing methods for influencing factors test, measurement data and the results of several aspects of the study. Production through the injection process to explore and repeated trial, combined with sodium chloride injection inosine made products and the overview of their research, carried out quality standards, quality control projects, qualitative research, and product stability of the research, carried out the data measurement and analysis. The results show that the product's high stability, good curative effect and side effects is small, the prospects for the domestic market more impressive.