PVC/PE/PVDC固体药用复合硬片PVDC涂布量测定

    Determination of PVDC Coating of PVC/PE/PVDC Composite Sheet for Solid Preparation

    • 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。

       

      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.

       

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