甲硝唑氯化钠注射液生产质量回顾研究
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摘要
通过甲硝唑氯化钠注射液的质量回顾,保证药品的安全生产要求。甲硝唑主要用于治疗或预防厌氧菌引起的系统或局部感染,如腹腔、消化道、女性生殖系、下呼吸道、皮肤及软组织、骨和关节等部位的厌氧菌感染,对败血症、心内膜炎、脑膜感染以及使用抗生素引起的结肠炎也有效。治疗破伤风常与破伤风抗毒素联用。还可用于口腔厌氧菌感染。甲硝唑水溶性差,一般制成盐,做成注射液使用。根据国家药品法规要求,企业对关键控制点要进行结果回顾分析。通过跟踪84批次的产品,进行的质量数据分析。结果是:成品甲硝唑氯化钠注射液的甲硝唑标示量在98.2%～102.8%之间,生产波动正常,在企业内控质量标准95.0%～105.0%之间。符合国家药典的标准含甲硝唑应为标示量的93.0%～107.0%。保证了药品的生产质量安全。
The quality of metronidazole sodium chloride injection is reviewed to ensure the safe production requirements of the drug. Metronidazole is mainly used to treat or prevent systemic or local infections caused by anaerobic bacteria, such as anaerobic infections in the abdominal cavity, digestive tract, female reproductive system, lower respiratory tract, skin and soft tissue, bones and joints, etc. It is also effective for sepsis, endocarditis, meninges infection, and colitis caused by the use of antibiotics. The treatment of tetanus is often combined with tetanus antitoxin. It can also be used for oral anorexia infection. Metronidazole has poor water solubility and is generally made into salt for injection use. According to the requirements of National drug laws and regulations, enterprises should conduct a retrospective analysis of the results of key control points. Quality data analysis by tracking 84 batches of products. The result is that the marked amount of metronidazole in the finished product metronidazole sodium chloride injection is between 98.2% and 102.8%, and the production fluctuations are normal, and the internal control quality standard is between 95.0% and 105.0%. The standard containing metronidazole in accordance with the National Pharmacopoeia should be 93.0% to 107.0% of the indicated amount. The quality and safety of medicines are guaranteed.
The quality of metronidazole sodium chloride injection is reviewed to ensure the safe production requirements of the drug. Metronidazole is mainly used to treat or prevent systemic or local infections caused by anaerobic bacteria, such as anaerobic infections in the abdominal cavity, digestive tract, female reproductive system, lower respiratory tract, skin and soft tissue, bones and joints, etc. It is also effective for sepsis, endocarditis, meninges infection, and colitis caused by the use of antibiotics. The treatment of tetanus is often combined with tetanus antitoxin. It can also be used for oral anorexia infection. Metronidazole has poor water solubility and is generally made into salt for injection use. According to the requirements of National drug laws and regulations, enterprises should conduct a retrospective analysis of the results of key control points. Quality data analysis by tracking 84 batches of products. The result is that the marked amount of metronidazole in the finished product metronidazole sodium chloride injection is between 98.2% and 102.8%, and the production fluctuations are normal, and the internal control quality standard is between 95.0% and 105.0%. The standard containing metronidazole in accordance with the National Pharmacopoeia should be 93.0% to 107.0% of the indicated amount. The quality and safety of medicines are guaranteed.
引文
[1]国家药典委员会,中华人民共和国药典2015年版二部[M],中国医药科技出版社2015:212-215.
[2]何敬文,王玉刚,药物化学[M].中国轻工业出版社,2016,(1):257-259.
[3]杨松岭,关力.药事法规管理[M].中国轻工业出版社,2016,8,150-151.
[4]王家波,杨晶,王涛等,维脑路通片压片工段工艺质量回顾分析[J].北方药学,2016,(16),1,87-88
[5]杨松岭,张之奎.药品GMP管理教程[M].中国轻工业出版社,2018,3,216-229
[2]何敬文,王玉刚,药物化学[M].中国轻工业出版社,2016,(1):257-259.
[3]杨松岭,关力.药事法规管理[M].中国轻工业出版社,2016,8,150-151.
[4]王家波,杨晶,王涛等,维脑路通片压片工段工艺质量回顾分析[J].北方药学,2016,(16),1,87-88
[5]杨松岭,张之奎.药品GMP管理教程[M].中国轻工业出版社,2018,3,216-229
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