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Pitt spiramycin , roxithromycin and maleic acid fasudil injection administration study

Author: FangJinLing
Tutor: HeZhongGui
School: Shenyang Pharmaceutical University
Course: Pharmaceutical preparations
Keywords: Pitt spiramycin Roxithromycin Water-soluble salts Maleate fasudil Safety Test Acute toxicity test
CLC: R94
Type: Master's thesis
Year: 2006
Downloads: 26
Quote: 0
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Abstract


Purpose must Laid spiramycin, roxithromycin as a model drug, the method to generate a water-soluble salt by reacting with an acid to increase the solubility of poorly soluble drugs, without adding organic solvent to prepare an injection with a powder, to optimize the clinical application; addition, The article also developed maleate fasudil injection dosage forms. Method at room temperature, the two macrolides were at a molar ratio 1:1 with different acid reactions, generated by the solubility of the salt as an indicator, to determine the purpose of the formulation is prepared possibility. Prescription screening and Technology visits concentrated with prepared liquid, freeze-drying method to prepare two macrocyclic drugs for injection powder for injection. Quality research and Stability of Pitt spiramycin powder for injection; quality research and Stability of roxithromycin powder for injection by HPLC method using HPLC method and microbiological assay; reference to chemical drugs irritant, allergic and hemolytic technical research guidelines injection roxithromycin injection security evaluation; acute toxicity test, determination of injection The the roxithromycin LD 50 ; through prescription screening and process investigation, developed maleate fasudil injectable dosage forms, and establish a HPLC method for quality and stability study of maleate fasudil injection dosage forms. Two macrolides with acid into salt solubility greatly improved, can make the necessary special spiramycin and roxithromycin concentration of 100mg/ml (pH4.5) 75mg/ml (pH 5.5 ). Preparation obtained from two freeze-dried powder specifications were: injection will be special spiramycin 200mg / branch injection roxithromycin 150mg / support; visits of the quality indicators, as well as the stability of the results of the experiment are in line with the Chinese Pharmacopoeia requirements for injection powder for injection; injection Roxithromycin injection security. Acute toxicity test, injection LD roxithromycin 50 and 95% confidence limits of 368.4 (335.2 ~ 405.0) mg / kg; maleate fasudil injection and lyophilized powder injection specifications: 2ml: 37mg, 37mg / support; visits of the quality indicators, as well as the stability of the results of the experiment are in line with the requirements of the Chinese Pharmacopoeia injections; injection maleate fasudil at high temperatures very unstable. Conclusion injection Pitt spiramycin injection roxithromycin and maleic acid fasudil injection safe, effective, stable and controllable quality; maleate fasudil unfit made from freeze-dried powder .

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