| Ribavirin is the nucleoside drugs chemical synthesis.It has the function of broad-spectrum antiviral effect, especially for the virus RNA and DNA. As an antiviral drug, Ribavirin primary manufacturers abroad for the ICN Scientists, and it is in the United States in1972listed in the first place. The trial of Ribavirin began in1973in China, and through the appraisal in1980. The raw material, injection, nasal drops and the production of documents through the identification in1981, which have been used for thirty years. Practice shows that Ribavirin has potent and broad spectrum antiviral effect comparing with other drugs. The antiviral effect is stronger than Ara-A and Ara-C, amantadine, Moroxydine, iodine and mercury. Therefore, Ribavirin has a wide clinical application range and it is one of the commonly used antiviral drugs currently in clinical for the treatment of various viral diseases, especially in treatment of some infectious disease.There are many kinds of Ribavirin preparations, but the Oral preparation work time slow, does not apply to patients with dysphagia; Topical formulations can’t effect the entire body, also can not be used for the treatment of acute viral infection; Injection is commonly used in clinical dosage form with the rapid efficacy and gastrointestinal mucosa irritation, and can avoid the first pass effect of oral dosage forms etc. In practical application, Ribavirin will be made to glucose injection, which can avoid many medical problems of some small injection joined into the infusion, such as the change of pyrogen, particulate, pH and so on.It can also make the nurse operation more easier, safer, and effectively avoiding cross pollution, meanwhile, ensuring the safe and effect of clinical treatment, and saving the effective time comparing with the injection.This study is based on relevant national standards through prescription screening test to determine the full prescribing of Ribavirin and glucose injection; The sterilization process selection and validation studies improved the sterilization parameters which increase to "121℃for heat8minutes," and the preparation of the production process meet the technical requirements of the national chemical injections. The larger problem of activated carbon adsorption of Ribavirin found in the experiments was improved through the test of the preparation process, and determined the drug added after the main process. After the influence factors scale sample test the formulation and preparation of Ribavirin and glucose injection was ultimately determine.The study established a scientific and complete quality inspection method through the quality standard of conduct systematic research and method validation of homemade Ribavirin and glucose injection. The results of the quality inspection of the goods in three sizes each of three batches of samples were qualified, shows that, this study of the prescription and preparation technology of injection production quality conforms to the national standard of pharmacopoeia. By influencing factor test, accelerated testing and long-term test to determine the product storage conditions and expiration dates, the requirements of this product should be sealed preservation in shading.It also shows that the product had no significant change in a certain period of time reasonable storage. The study suggest that the process route of Ribavirin and glucose injection is short and simple operation, low cost and less pollution, also the production process is reasonable, could realize the industrialization of large-scale production. Research of quality control standards can be used widely, which can provide the reference for the industrial production in the future and can also provide quality assurance for Ribavirin and glucose injection curing the viral diseases more safe and effective. |
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