| 引用本文: | 戚继红,岳莉,沈伟.HQ841水凝胶树脂粉微生物限度检查方法验证[J].中国现代应用药学,2013,30(11):1226-1228. |
| QI Jihong,YUE Li,SHEN Wei.Validation of Microbial Limit Method of HQ841 Hydrogel Resin Powder[J].Chin J Mod Appl Pharm(中国现代应用药学),2013,30(11):1226-1228. |
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| 摘要: |
| 目的 建立HQ841水凝胶树脂粉微生物限度检查法，并对方法进行验证。方法 将供试品配制为1∶20的溶液，按常规法进行细菌数、霉菌和酵母菌数检查及控制菌(铜绿假单胞菌、金黄色葡萄球菌)的检查。结果 在3次独立的平行试验中，细菌数、霉菌和酵母菌数检查方法的验证试验，5株试验菌回收率均>70%；控制菌测定中，检查铜绿假单胞菌和金黄色葡萄球菌，试验组均可检出试验菌。结论 采用常规法进行HQ841水凝胶树脂粉细菌数、霉菌和酵母菌计数及控制菌检查，方法有效可行。 |
| 关键词: HQ841水凝胶树脂粉 微生物限度检查法 方法学验证 |
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| Validation of Microbial Limit Method of HQ841 Hydrogel Resin Powder |
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QI Jihong, YUE Li, SHEN Wei
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Huaibei Institute for Food and Drug Control of Anhui Province, Huaibei 235000, China
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| Abstract: |
| OBJECTIVE To establish a method for the microbial limit test of HQ841 hydrogel resin powder. METHODS The sample preparation of 1∶20 solution, bacteria, yeast and mold counts the number of inspection and control bacteria by conventional method (Pseudomonas aeruginosa, Staphylococcus aureus) examination. RESULTS In the parallel test of 3 independent, verification test bacteria, yeast and mold count number check method, 5 strains of tested bacteria recovery rate was >70%. The control bacteria examination determination, Pseudomonas aeruginosa and Staphylococcus aureus, the test group were detected bacteria, negative group are sterile growth, Gram-negative bacteria in the control group had no growth. CONCLUSION The method can be used in microbial limit test of HQ841 hydrogel resin powder. |
| Key words: HQ841 hydrogel resin powder microbial limit test validation of method |
