棓丙酯氯化钠注射液制备工艺的研究

目的为增加棓丙酯氯化钠注射液稳定性和用药的安全性,对其进行制备工艺研究。方法主要通过加入亚硫酸氢钠和依地酸钙钠防止棓丙酯被氧化和与金属离子发生显色反应,用盐酸调pH3.0~5.0,活性炭用量为配液量的0.02%(g.ml-1),采用115℃湿热蒸汽灭菌30min。结果经上述条件生产的棓丙酯氯化钠注射液经检验各项指标均合格,稳定性考察试验到目前为止各项指标均合格。结论以亚硫酸氢钠和依地酸钙钠为抗氧剂和金属络合剂,盐酸调pH3.0~5.0,活性炭用量为0.02%(g.ml-1),灭菌温度为115℃湿热蒸汽灭菌30min,作为棓丙酯氯化钠注射液生产条件是可行的,产品是稳定可靠的。

Technological research of Propylgallate and Sodium Chloride Injection

OBJECTIVE To increase the stability of Propylgallate and Sodium Chloride Injection as well as the security of administration,research on its preparation technology was carried out.METHODS Mainly through adding Sodium bisulfite and Calcium Disodium Edtate to prevent propygallate from being oxidated as well as chromogenic reaction with metal ions,adjusting pH 3.0～5.0 with hydrochloric acid,the quality of activated charcoal used is 0.02% of the solution,sterilization using moist heat must be done at 115℃ for 30 minutes.RESULTS Propygallate and Sodium Chloride Injection produced under this condition was tested that all indexes were qulification,stability testing was by far satisfactory.CONCLUSION It′s available to use Sodium bisulfite and Calcium Disodium Edtate as antioxygen and mental complexant,adjusting pH 3.0～5.0 with hydrochloric acid,the level of activated charcoal was 0.02%(g·ml~(-1)),moist heat sterilization at 115℃ for 30 minutes as condition of producing propylgallate and sodium chloride injection,its production was stabile and reliable.