| 甄晓兰.苯巴比妥钠注射液细菌内毒素检查法标准研究[J].中国药品标准,2017,18(5):394-400 |
| 苯巴比妥钠注射液细菌内毒素检查法标准研究 |
| Study on Bacterial Endotoxin Test of Phenobarbital Sodium Injection |
| 投稿时间：2017-07-19 修订日期：2017-10-19 |
| DOI： |
| 中文关键词: 苯巴比妥钠注射液 热原物质 细菌内毒素 |
| 英文关键词: Phenobarbital sodium Injection pyrogen bacterial endotoxin |
| 基金项目:河北省科技计划项目(编号16272610),项目名称：苯巴比妥钠注射液的质量标准提高研究 |
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| 中文摘要: |
| 目的：苯巴比妥钠注射液现有检验标准“国家药品标准WS1-XG-058-2011”无细菌内毒素或热原检查项目,一方面给临床造成很大的安全隐患,另一方面也不符合“注射剂安全检查法应用指导原则” [1]。建立该品种的细菌内毒素检查方法非常必要。方法：依照《中国药典》2015年版四部1143检查法[2],采用凝胶限量法对两个厂家4个批次的苯巴比妥钠注射液进行干扰试验,拟定细菌内毒素检查限值；另取两个厂家8个批次的苯巴比妥钠注射液按拟定细菌内毒素检查限值采用凝胶法和动态浊度法对其进行定性和定量检验,验证方法的可行性。结果：根据干扰试验结果,参考USP40-NF35.2017苯巴比妥钠注射液细菌内毒素检验[3],拟定每1mg苯巴比妥钠中含细菌内毒素的量应小于0.3EU；采用凝胶法和动态浊度法对两个厂家8个批次的苯巴比妥钠注射液按细菌内毒素的限值小于0.3EU.mg-1 进行检查,结果均符合规定。结论：该实验建立的细菌内毒素检查法适用于苯巴比妥钠注射液。拟定标准：取本品,依法检验(《中国药典》2015年版四部1143),每1mg苯巴比妥钠注射液中含细菌内毒素的量应小于0.3EU.与USP40-NF35.2017苯巴比妥钠注射液细菌内毒素检验结果一致。 |
| 英文摘要: |
| ABSTRACT OBJECTIVE: : The current inspection standards about phenobarbital sodium injection "national drug standards WS1 - XG - 058-2011" has no bacterial endotoxin or pyrogen inspection, on the one hand this can cause clinical potential safety concerns，on the other hand this does not comply the "injection safety test application guidelines" [1] .To establish the bacterial endotoxin determination method of phenobarbital sodium injection is quite essential. METHODS: The interference test of 4 batches of phenobarbital sodium injection from 2 manufacturers were carried out in accordance with the bacterial endotoxin test approved by Chinese Pharmacopeia (2015 Vol.Ⅳ1143). Draw up the limit value of bacterial endotoxin. Another taking 8 batches of phenobarbital sodium injection from 2 manufacturers were tested bacterial endotoxin according prepared limits by using the gel clot method and kinetic turbidimetric method, to verify the method is feasible.RESULTS: No interference was found in the bacterial endotoxin test after phenobarbital sodium injection was diluted to 0.83mg?mL-1 .The limit value of the bacterial endotoxin could be 0.3EU of endotoxin per mg of phenobarbital sodium injection. The results of the bacterial endotoxin test of the 8 batches of samples were all accorded with the standard of the established quality control. CONCLUSION: The bacterial endotoxin determination method of phenobarbital sodium injection: Take this production accordance with the bacterial endotoxin test approved by Chinese Pharmacopeia (2015 Vol.Ⅳ1143), it contains not more than 0.3EU of endotoxin per mg of phenobarbital sodium, and consisted with the USP(40-NF35.2017 Vol 3).Thus, the product is safe for clinical application. |
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