| 引用本文: | 訾晓伟,王丹丹,陈超,俞辉.PVC/PE/PVDC固体药用复合硬片PVDC涂布量测定[J].中国现代应用药学,2018,35(9):1327-1328. |
| ZI Xiaowei,WANG Dandan,CHEN Chao,YU Hui.Determination of PVDC Coating of PVC/PE/PVDC Composite Sheet for Solid Preparation[J].Chin J Mod Appl Pharm(中国现代应用药学),2018,35(9):1327-1328. |
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| 摘要: |
| 目的 建立一种测定聚氯乙烯/聚乙烯/聚偏二氯乙烯（PVC/PE/PVDC）固体药用复合硬片PVDC涂布量的方法。方法 裁取10 cm×10 cm的样品5片，将样品先在丙酮中浸泡，分离得到PVC层和PE/PVDC复合层。将PE/PVDC复合层于80℃中干燥2 h后，于23℃放置4 h，精密称定。再将PE/PVDC复合层在四氢呋喃中浸泡，使PVDC层溶解在四氢呋喃溶液中，得到PE膜层，于80℃中干燥2 h后，于23℃放置4 h，精密称定，前后2次差值即为PVDV质量（g）。最后计算PVDC涂布量（以g·m-2表示）。结果 5批样品PVDC涂布量测定结果与标示涂布量均一致，且偏差均在±5%之内。结论 该方法准确、灵敏，适用于PVC/PE/PVDC固体药用复合硬片PVDC涂布量的测定。 |
| 关键词: PVC/PE/PVDC固体药用复合硬片 PVDC涂布量 测定 |
| DOI：10.13748/j.cnki.issn1007-7693.2018.09.012 |
| 分类号:R943 |
| 基金项目:国家药典委员会2017年国家药品标准提高任务课题（373） |
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| Determination of PVDC Coating of PVC/PE/PVDC Composite Sheet for Solid Preparation |
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ZI Xiao-wei,WANG Dandan,CHEN Chao and YU Hui
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Zhejiang Institute for Food and Drug Control,Key Laboratory of Drug Contacting Materials Quality Control of Zhejiang Province,Zhejiang Institute for Food and Drug Control,Key Laboratory of Drug Contacting Materials Quality Control of Zhejiang Province,Zhejiang Institute for Food and Drug Control,Key Laboratory of Drug Contacting Materials Quality Control of Zhejiang Province,Zhejiang Institute for Food and Drug Control,Key Laboratory of Drug Contacting Materials Quality Control of Zhejiang Province
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| Abstract: |
| OBJECTIVE To develop a method for determination of PVDC coating of PVC/PE/PVDC composite sheet for solid preparation. METHODS Cut off 5 pieces of samples of 10 cm×10 cm, immersed in acetone to separate PE/PVDC composite layer from PVC layer. Dried PE/PVDC composite laied in 80℃ for 2 h, then laied in 23℃ for 4 h and weighed. Immersed PE/PVDC composite layer in THF, dissolved PVDC and obtained PE layer, dried PE layer in 80℃ for 2 h, then laied in 23℃ for 4 h and weighed. The difference of two weights was PVDC coating amount. Then calculated the PVDC coating (g·m-2). RESULTS Determination results of PVDC coatings of 5 batch samples were consistent with labelled PVDC coating and deviation was within ±5%. CONCLUSION This method is accurate, sensitive, it can be used for determination of PVDC coating of PVC/PE/PVDC composite sheet for solid preparation. |
| Key words: PVC/PE/PVDC composite sheet for solid preparation PVDC coating determination |
