| As the world develops, the pace of people's life becomes faster and faster, which results in the increased incidence of gastrointestinal diseases.If gastrointestinal diseases was lack of timely, appropriate treatment, it would seriously affect the quality of the patient's life. Even it would likely deteriorate, leading to gastrointestinal perforation or cancers. Lansoprazole is a second generation proton pump inhibitor following omeprazole, with advantages such as high cure rate, reducing the symptoms faster,high bioavailability, few side effects, cheap. This subject is studying a safe, effective, quality controllable preparation for the treatment of gastric ulcer, duodenal ulcer, reflux esophagitis.To develop lansoprazole into a new preparation through the preliminary study on its production process, quality standards and pharmaceutical.The prescription of this subject is from the lansoprazole for injection of TAP Pharmaceuticals, the prescription has been applicated clinically for many years abroad, and there is few related reports of adverse reactions so far. Based on evaluating and determinating physical and chemical properties of the API(Active Pharmaceutical Ingredient) and studying the nature of the preparation, to choose the appropriate technology in the prescription process. It's very important for designing a stable,safe preparation. And according to L9(34)orthogonal survey conducted with the solubility of lansoprazole and the shape skeleton structure as the appraising index.The best prescription is:Lansoprazole 1.5%,eglumine 1.5%,mannitol 3%,appropriate sodium hydroxide.water for injection to full capacity. By measuring the eutectic point of lansoprazole, we have determined the freeze-dried curve of lansoprazole for injection, and the freeze-drying process is:cooling rate is down to below-35℃in 1.5～2h, the freeze temperature is below-35℃, maintenance time is 6-7h, the product temperature is≤-30℃, shelf temperature is -12℃～9℃, the condenser temperature is≤-50℃, the vacuum of the former case is≤10pa, the vacuum of the back case is≤5pa, the shelf heating rate is -9℃～40℃about 6h, products, the maximum temperature is≤39℃, condenser temperature≤-55℃.To establish a appropriate appropriate quality standards is of extremely importance to insure the preparations'quality controllablity. It not only involves the development of enterprises, but also insures patients, consumer's safety, rights.The subject have studied the quality standerd of lansoprazole for injection combining the characeteristics and relevant requirements of injection. According to the literatures, we have established quality controling requirements of the preparation's character, identification, pH, solution clarity and color, related substances, moisture, insoluble particles, bacterial endotoxin, load difference, and determination, et al. The study in this subject provides experimental basis and reference for the quality standards drafting. Through the investigating the factors,we have determined that:lansoprazole for injection should be preserved in dark, cool place because the powder is unstable to light and heat.The stability of the preparation is important content in pharmaceutics,and to prepare a stable preparation is the guarantee for the preparation playing a better role and reducing toxicity. Preddicting the preparation's stability accurately plays a key role in studing the prscrition and determining the manufacturing technique. According to Chinese Pharmacopoeia and combined with lansoprazole for injection's regulations of pre-production quality standards draft, we determine to focus on investigating characteristics, pH, related substances, sterility, determination of lansoprazole for injection. We use HPLC (high performance liquid chromatography) to testing related substances and determing lansoprazole for injection. Each indicator of lansoprazole for injection has no significant change at 40℃for 6 months in accelerated test and long-term test for 6 months. It means that the preparation,lansoprazole for injection,is stable, effective and it can achieve the requirements in quality control. |
PDF Full Text Request