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Study On Improvement Of The Preparation Technology & Stability Of 25% Vitamin C Injection

Posted on:2011-10-08Degree:MasterType:Thesis
Country:ChinaCandidate:Y S ZhangFull Text:PDF
GTID:2154330338482020Subject:Pharmaceutical Engineering
Abstract/Summary:PDF Full Text Request
25% vitamin C injection is widely used in various types of urgent treatment and prevention of chronic diseases. However, 25% vitamin C injection during storage may easily turns to yellow color. Also, the exploration from the ample usually results in the injury to the clinical individuals. thus to the production, storage, use a lot more difficult, a direct impact on the 25% vitamin C injection in clinical applications.Injection based on the impact of the characteristics of stability, in the prescribed course of the study were prescribed or thogonal design, the impact from raw materials, the choice of antioxidant, sterilization time for the identification, determination of the amount of activated carbon, the effects of metal ions, the order is expected to vote the impact of experimental studies, and the ultimate prescription for the study of the impact of factors to determine the best prescription manufacturing process. Prescription is as follows: Vitamin C: 2500g; sodium bicarbonate: 1250g; sodium sulfate: 20g; sodium dithionite: 20g; L-cysteine: 20 g; EDTA-2Na: 300mg; activated: 5g; water for injection added to 10000 ml. Based on "People's Republic of China PHarmacopoeia" (2005 version) the requirements of content, color, pH, bacterial endotoxin, sterile focused inspection.Process for the preparation of prescriptions according to the above 3 samples were approved for 6 months accelerated testing and long-term 36-month stability test results show that: In accordance with the production of the prescription and procedures listed on the packaging of products in the quality and stability under the conditions of quality, the packaging conditions for storage and transportation of drugs to meet the requirements. Reference to the goods in the course of the study preparation process factors affect the test results will be valid for the products identified as two years.Based on the production of the prescription process, and products to better control the 25% injection of vitamin C content, color, pH value changes, prescription reasonable quality; At the same time, reducing the high material and lower production costs, and ensure the validity of to meet the market demand to create economic benefits for the enterprise.
Keywords/Search Tags:Vitamin C injection, manufacturing technology, quality control, stability
PDF Full Text Request
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