盐酸莫西沙星氯化钠注射液的制备研究  

Preparation of moxifloxacin hydrochloride and sodium chloride injection

作　　者：赵越 王明伟 孙莹莹 孙长山[1] ZHAO Yue;WANG Mingwei;SUN Yingying;SUN Changshan(School of Pharmacy,Shenyang Pharmaceutical University,Shenyang 110016,China)

机构地区：[1]沈阳药科大学药学院,辽宁沈阳110016

出　　处：《中国药剂学杂志》2021年第5期145-153,共9页Chinese Journal of Pharmaceutics

摘　　要：目的制备盐酸莫西沙星氯化钠注射液。方法参考德国拜耳医药保健有限公司的盐酸莫西沙星氯化钠注射液的处方,通过考察原辅料的相容性、原辅料与注射用水的加入顺序、注射用水首次加入量、样品的溶解温度、制剂的pH、活性炭用量、灭菌条件及包材,确定制剂的处方和工艺。结果最终确定盐酸莫西沙星氯化钠注射液的处方以及制备工艺;取约总量60%的注射用水,加热至70~80℃,加入0.4364 g的盐酸莫西沙星,搅拌使溶解;再加入2.0 g氯化钠,搅拌使溶解,用20 mmol·L^(-1)盐酸溶液调节pH至4.2~4.5,补加注射用水至全量250 mL;用0.22μm微孔滤膜滤过,灌封,经121℃/15 min灭菌,即得。结论最终确定了适合于工业化大生产的处方及制备工艺,且自制样品的质量与原研制剂相当。Objective To prepare moxifloxacin hydrochloride and sodium chloride injection.Methods Based on moxifloxacin hydrochloride and sodium chloride injection from Bayer healthcare Co.,Ltd,the formulation and process of the preparation were determined by investigating the compatibility of raw and auxiliary materials,the adding sequence of raw and auxiliary materials and water for injection,the first adding amount of water for injection,the dissolving temperature of the drug,the pH value of the preparation,the amount of activated carbon,sterilization conditions and packaging materials.Results The final formulation and preparation process of moxifloxacin hydrochloride and sodium chloride injection were determined as follows:about 60%of the total amount of water for injection was heated to 70~80℃,and 0.4364 g of moxifloxacin hydrochloride was added with stirring until the drug was totally dissolved;2.0 g of sodium chloride was added,and stirred to be completely dissolved;the pH value was adjusted to 4.2~4.5 with 0.02 mol·L^(-1) hydrochloric acid solution;the water for injection was added up to total volume of 250 mL;After filtration with 0.22μm microporous membrane,encapsulation and sterilization at 121℃for 15 min,the final product was obtained.Conclusions The formulation and preparation process suitable for industrial production are determined,and the quality of the self-made samples is equivalent to that of the original preparation.

关 键 词：盐酸莫西沙星 氯化钠 注射液 制备 

分 类 号：R94[医药卫生—药剂学]